Journal: Catheter Cardiovasc Interv

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<div><h4>Transcatheter aortic valve replacement-related aortic dissection: A clinical case series.</h4><i>Hiruma T, Higuchi R, Saji M, Takamisawa I, Shimokawa T, Nanasato M</i><br /><b>Objectives</b><br />We review our experience with 13 periprocedural aortic dissection (AD) cases caused by transcatheter aortic valve replacement (TAVR).<br /><b>Background</b><br />AD is a potentially lethal complication of TAVR; however, only sporadic case reports have been published to date.<br /><b>Methods</b><br />Among 1335 consecutive patients who underwent TAVR in 2013-2021, we retrospectively extracted 13 patients (1.0%) with TAVR-related AD (Stanford type A in 6 [46%], type B in 7 [54%]). AD was defined as a new-onset dissected layer of the aortic wall and diagnosed by aortography, computed tomography, or transesophageal echocardiography.<br /><b>Results</b><br />Five of the six type A AD cases (83%) were detected during TAVR versus only one of the seven type B AD cases (14%). Four of the seven type B AD cases (57%) were asymptomatic and incidentally detected on computed tomography. The presumed causes of AD were injury by the delivery sheath (39%), delivery catheter (23%), valve implantation (15%), stent edge (15%), and pre-dilation balloon (8%). Complicated AD occurred in only one patient (8%). Considering the patient\'s age and prohibitive surgical risk, all patients were treated conservatively and free of any aortic-related deaths or interventions during a follow-up of 1087 days.<br /><b>Conclusions</b><br />TAVR-related AD is a rare but life-threatening condition that may be underdiagnosed. Its optimal therapy remains unclear, and conservative management might be an option for selected patients. Further studies are needed to elucidate the incidence, risk factors, effective screening, optimal therapy, and outcomes of TAVR-related AD.<br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 26 Jan 2023; epub ahead of print</small></div>
Hiruma T, Higuchi R, Saji M, Takamisawa I, Shimokawa T, Nanasato M
Catheter Cardiovasc Interv: 26 Jan 2023; epub ahead of print | PMID: 36701398
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<div><h4>Single vs. multiple operators for chronic total occlusion percutaneous coronary interventions: From the PROGRESS-CTO Registry.</h4><i>Karacsonyi J, Alaswad K, Krestyaninov O, Karmpaliotis D, ... Brilakis ES, Sandoval Y</i><br /><b>Background</b><br />There is limited data on the impact of a second attending operator on chronic total occlusion (CTO) percutaneous coronary intervention (PCI) outcomes.<br /><b>Methods</b><br />We analyzed the association between multiple operators (MOs) (>1 attending operator) and procedural outcomes of 9296 CTO PCIs performed between 2012 and 2021 at 37 centers.<br /><b>Results</b><br />CTO PCI was performed by a single operator (SO) in 85% of the cases and by MOs in 15%. Mean patient age was 64.4 ± 10 years and 81% were men. SO cases were more complex with higher Japan-CTO (2.38 ± 1.29 vs. 2.28 ± 1.20, p = 0.005) and Prospective Global Registry for the Study of Chronic Total Occlusion Intervention scores (1.13 ± 1.01 vs. 0.97 ± 0.93, p < 0.001) compared with MO cases. Procedural time (131 [87, 181] vs. 112 [72, 167] min, p < 0.001), fluoroscopy time (49 [31, 76] vs. 42 [25, 68] min, p < 0.001), air kerma radiation dose (2.32 vs. 2.10, p < 0.001), and contrast volume (230 vs. 210, p < 0.001) were higher in MO cases. Cases performed by MOs and SO had similar technical (86% vs. 86%, p = 0.9) and procedural success rates (84% vs. 85%, p = 0.7), as well as major adverse complication event rates (MACE 2.17% vs. 2.42%, p = 0.6). On multivariable analyses, MOs were not associated with higher technical success or lower MACE rates.<br /><b>Conclusion</b><br />In a contemporary, multicenter registry, 15% of CTO PCI cases were performed by multiple operators. Despite being more complex, SO cases had lower procedural and fluoroscopy times, and similar technical and procedural success and risk of complications compared with MO cases.<br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 25 Jan 2023; epub ahead of print</small></div>
Karacsonyi J, Alaswad K, Krestyaninov O, Karmpaliotis D, ... Brilakis ES, Sandoval Y
Catheter Cardiovasc Interv: 25 Jan 2023; epub ahead of print | PMID: 36695421
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<div><h4>Impact of complex percutaneous coronary intervention features on clinical outcomes in patients with or without chronic kidney disease.</h4><i>Chen H, Spirito A, Sartori S, Nicolas J, ... Dangas G, Mehran R</i><br /><b>Background</b><br />Patients with chronic kidney disease (CKD) are at higher risk of ischemic and bleeding events after percutaneous coronary intervention (PCI). Complex PCI (CPCI) is associated with higher rates of ischemic complications. Whether CPCI confers an additive risk of adverse events in CKD patients is unclear.<br /><b>Methods</b><br />Patients who underwent PCI at a single tertiary-care-center between 2012 and 2019 were stratified by CKD status and CPCI. The primary outcome was major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), and target-vessel revascularization (TVR) at 1-year follow-up. Secondary outcomes included the individual components of the primary outcome and major bleeding.<br /><b>Results</b><br />Out of 15,071 patients, 4537 (30.1%) had CKD and 10,534 (69.9%) had no CKD. Patients undergoing CPCI were 1151 (25.4%) and 2983 (28.3%) in the two cohorts, respectively. At one year, CPCI compared with no CPCI was associated with higher risk of MACE in both CKD (Adj. HR 1.72, 95% confidence interval [CI] 1.45-2.06, p < 0.001) and no-CKD patients (Adj. hazard ratios [HR] 2.19, 95% CI 1.91-2.51, p < 0.001; p of interaction 0.057), determined by an excess of death, MI and TVR in CKD patients and of TVR and MI only in no-CKD. CPCI was related with a consistent increase of major bleeding in the CKD (Adj. HR 1.49, 95% CI 1.18-1.87, p < 0.001) and no-CKD group (Adj. HR 1.23, 95% CI 0.98-1.54, p = 0.071, p of interaction 0.206).<br /><b>Conclusion</b><br />At 1-year follow-up, CPCI was associated with higher risk of MACE and major bleeding irrespective of concomitant CKD. CPCI predicted mortality in CKD patients only.<br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 24 Jan 2023; epub ahead of print</small></div>
Chen H, Spirito A, Sartori S, Nicolas J, ... Dangas G, Mehran R
Catheter Cardiovasc Interv: 24 Jan 2023; epub ahead of print | PMID: 36691863
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<div><h4>Novel dual guiding catheter technique for kissing balloon inflation in percutaneous coronary intervention for bifurcated chronic total occlusive lesion.</h4><i>Kawamura Y, Yoshimachi F, Kasai S, Ikari Y</i><br /><AbstractText>Traditionally, two bigger-sized guiding catheters (GCs) via the femoral artery have been used in percutaneous coronary intervention (PCI) for chronic total occlusion (CTO). However, those GCs are associated with an increased incidence of bleeding. Therefore, the use of smaller GCs (e.g., 5-Fr) may lessen the invasiveness of this procedure. However, the use of 5-Fr GCs in PCI is complicated by device limitations. A novel technique was developed to overcome the challenges with regard to kissing balloon inflation. This approach involves simultaneous balloon inflation through a dual 5-Fr GC technique for CTO-PCI. In our hospital, this technique was successfully performed in 9 cases of CTO with 10 bifurcated lesions (including four left main-related bifurcations). During the study period, there was no requirement for an additional invasive procedure or occurrence of complications related to the PCI procedure. This technique may be a good option for performing KBI during CTO-PCI through the use of two 5-Fr GCs.</AbstractText><br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 24 Jan 2023; epub ahead of print</small></div>
Kawamura Y, Yoshimachi F, Kasai S, Ikari Y
Catheter Cardiovasc Interv: 24 Jan 2023; epub ahead of print | PMID: 36691868
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<div><h4>Percutaneous treatment of multiple fistulas associated with a giant aneurysm.</h4><i>Vera-Vera S, Jurado-Roman A, Moreno R, Galeote G</i><br /><AbstractText>Coronary fistulas are not common in patients undergo coronary angiography. It is described, even less frequently, that coronary fistulas may be associated with giant aneurysms along their course. These cases classically are treated surgically. We present a case treated fully percutaneously in a novel fashion.</AbstractText><br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 24 Jan 2023; epub ahead of print</small></div>
Vera-Vera S, Jurado-Roman A, Moreno R, Galeote G
Catheter Cardiovasc Interv: 24 Jan 2023; epub ahead of print | PMID: 36691874
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<div><h4>Role of the retrograde Carlino technique for chronic total occlusion percutaneous coronary intervention.</h4><i>Azzalini L, Boudou N, Avran A, Kane J, ... Kearney KE, Carlino M</i><br /><b>Background</b><br />There is scarce data on the outcomes of the Carlino technique for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We aimed to investigate the indications and outcomes of the Carlino technique as performed in the context of the retrograde approach.<br /><b>Methods</b><br />We pooled CTO PCI cases where a retrograde Carlino technique was performed from high-volume operators at four centers. The Carlino technique was characterized according to its indication (achieving plaque/cap modification, clarifying microcatheter location within the vessel, resolving distal cap ambiguity) and was considered successful when it led to the desired outcome.<br /><b>Results</b><br />A total of 43 patients were included. Occlusion complexity was very high (mean J-CTO score 3.3 ± 0.8). The two most common indications were understanding the anatomy of the occlusion and clarifying gear location (37.2%) and impenetrable distal cap (34.9%). The Carlino technique was successful in 88.4% of cases. Overall technical and procedural success was 86.0%. The most common successful crossing technique was reverse controlled antegrade and retrograde subintimal tracking (70.3%). No complications were attributed to the Carlino technique.<br /><b>Conclusions</b><br />We observed a high success rate of the retrograde Carlino technique, as well as overall technical and procedural success rates. No Carlino technique-related complications were observed. Additional data from larger registries are warranted to further confirm the safety and efficacy of this technique.<br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 22 Jan 2023; epub ahead of print</small></div>
Azzalini L, Boudou N, Avran A, Kane J, ... Kearney KE, Carlino M
Catheter Cardiovasc Interv: 22 Jan 2023; epub ahead of print | PMID: 36682073
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<div><h4>Left atrial appendage closure in end-stage renal disease and hemodialysis: Data from a German multicenter registry.</h4><i>Fink T, Paitazoglou C, Bergmann MW, Sano M, ... Sandri M, Eitel I</i><br /><b>Background</b><br />Left atrial appendage closure (LAAC) has emerged as an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). OAC treatment has been proven feasible in mild-to-moderate chronic kidney disease (CKD). In contrast, the optimal antithrombotic management of AF patients with end-stage renal disease (ESRD) is unknown and LAAC has not been proven in these patients in prospective randomized clinical trials.<br /><b>Objectives</b><br />The objective of this study is to evaluate safety and efficacy of LAAC in patients with ESRD.<br /><b>Methods</b><br />Patients undergoing LAAC were collected in a German multicenter real-world observational registry. A composite endpoint consisting of the occurrence of ischemic stroke/transient ischemic attack, systemic embolism, and/or major clinical bleeding was assessed. Patients with ESRD were compared with propensity score-matched patients without severe CKD. ESRD was defined as a glomerular filtration rate < 15 ml/min/1.73 m<sup>2</sup> or chronic hemodialysis treatment.<br /><b>Results</b><br />A total of 604 patients were analyzed, including 57 with ESRD and 57 propensity-matched patients. Overall, 596 endocardial and 8 epicardial LAAC procedures were performed. Frequency of major complications was 7.0% (42/604 patients) in the overall cohort, 8.8% (5/57 patients) in patients with ESRD, and 10.5% (6/57 patients) in matched controls (p = 0.75). The estimated event-free survival of the combined endpoint after 500 days was 90.7 ± 4.5% in patients with ESRD and 90.2 ± 5.5% in matched controls (p = 0.33).<br /><b>Conclusions</b><br />LAAC had comparable procedural safety and clinical efficacy in patients with ESRD and patients without severe CKD.<br /><br />© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 22 Jan 2023; epub ahead of print</small></div>
Fink T, Paitazoglou C, Bergmann MW, Sano M, ... Sandri M, Eitel I
Catheter Cardiovasc Interv: 22 Jan 2023; epub ahead of print | PMID: 36682074
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<div><h4>Validation of the new PROGRESS-CTO complication risk scores in the OPEN-CTO registry.</h4><i>Azzalini L, Hirai T, Salisbury A, Gosch K, ... Lombardi WL, Grantham JA</i><br /><b>Background</b><br />Risk stratification before chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is important to inform procedural planning as well as patients and their families. We sought to externally validate the PROGRESS-CTO complication risk scores in the OPEN-CTO registry.<br /><b>Methods</b><br />OPEN-CTO is a prospective registry of 1000 consecutive CTO PCIs performed at 12 experienced US centers using the hybrid algorithm. Endpoints of interest were in-hospital all-cause mortality, need for pericardiocentesis, acute myocardial infarction (MI), and major adverse cardiovascular events (MACE) (a composite of all-cause mortality, stroke, periprocedural MI, urgent repeat revascularization, and tamponade requiring pericardiocentesis). Model discrimination was assessed with the area under the curve (AUC) method, and calibration with the observed-versus-predicted probability method.<br /><b>Results</b><br />Mean age was 65.4 ± 10.3 year, and 36.5% of patients had prior coronary artery bypass graft. Overall, 41 patients (4.1%) suffered MACE, 9 (0.9%) mortality, 26 (2.6%) acute MI, and 11 (1.1%) required pericardiocentesis. Technical success was achieved in 86.3%. Patients who experienced MACE had higher anatomic complexity, and more often required antegrade dissection/reentry and the retrograde approach. Increasing PROGRESS-CTO MACE scores were associated with increasing MACE rates: 0.5% (score 0-1), 2.4% (score 2), 3.7% (score 3), 4.5% (score 4), 7.8% (score 5), 13.0% (score 6-7). The AUC were as follows: MACE 0.72 (95% confidence interval [CI]: 0.66-0.78), mortality 0.79 (95% CI: 0.66-0.95), pericardiocentesis 0.71 (95% CI: 0.60-0.82), and acute MI 0.57 (95% CI: 0.49-0.66). Calibration was adequate for MACE and mortality, while the models underestimated the risk of pericardiocentesis and acute MI.<br /><b>Conclusions</b><br />In a large external cohort of patients treated with the hybrid algorithm by experienced CTO operators, the PROGRESS-CTO MACE, mortality, and pericardiocentesis risk scores showed good discrimination, while the acute MI score had inferior performance.<br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 22 Jan 2023; epub ahead of print</small></div>
Azzalini L, Hirai T, Salisbury A, Gosch K, ... Lombardi WL, Grantham JA
Catheter Cardiovasc Interv: 22 Jan 2023; epub ahead of print | PMID: 36682075
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<div><h4>Percutaneous coronary intervention with drug-coated balloon-only strategy combined with single antiplatelet treatment in patients at high bleeding risk: Single center experience of a novel concept.</h4><i>Räsänen A, Kärkkäinen JM, Eranti A, Eränen J, Rissanen TT</i><br /><b>Objectives</b><br />At least 1 month of dual antiplatelet therapy is required after coronary stenting. The aim of this all-comers retrospective registry study was to assess the efficacy and safety of percutaneous coronary intervention (PCI) using drug-coated balloon (DCB) with single antiplatelet treatment (SAPT).<br /><b>Methods</b><br />Between 2011 and 2020, 232 PCIs were performed in 172 patients using the DCB-only strategy and discharged with SAPT.<br /><b>Results</b><br />The mean age of the patients was 75 ± 11 years and 59% were male. The clinical presentation was stable coronary artery disease (CAD) in 42% of the patients and acute coronary syndrome (ACS) in 58%. The lesions were mainly de novo (96%). The majority (58%) of treated lesions were in large coronary arteries (≥3.0 mm). Most (87%) of the patients were at high bleeding risk (HBR) with at least one major or two minor Academic Research Consortium (ARC) risk factors for bleeding. Periprocedural DAPT was used in 49% of the patients. The 12-month major adverse cardiac events (MACE, the composition of cardiovascular death, nonfatal myocardial infarction, and target-lesion revascularization) rate was 1.4% in stable CAD and 7.1% in ACS. The 12-month all-cause mortality after DBC only + SAPT strategy was 4.1% in stable CAD and 12.1% in ACS. The rate of ischemia-driven target lesion revascularisation (TLR) was 0% in stable CAD and 3.0% in ACS at 12 months. The 12-month rate of significant bleeding (BARC type 2-5) was 10.5%. There were no acute or subacute vessel closures.<br /><b>Conclusions</b><br />Despite the aged patient population with comorbidities, the TLR, MACE, and bleeding rates were low with DCB-only PCI combined with SAPT. This novel approach could reduce the post-PCI bleeding risk in patients with CAD and HBR compared to stenting.<br /><br />© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 22 Jan 2023; epub ahead of print</small></div>
Räsänen A, Kärkkäinen JM, Eranti A, Eränen J, Rissanen TT
Catheter Cardiovasc Interv: 22 Jan 2023; epub ahead of print | PMID: 36682076
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<div><h4>Cusp-overlap versus coplanar view in transcatheter aortic valve implantation with self-expandable valves: A meta-analysis of comparative studies.</h4><i>Sá MP, Van den Eynde J, Jacquemyn X, Erten O, ... Sicouri S, Ramlawi B</i><br /><b>Background</b><br />Permanent pacemaker implantation (PPI) is a common complication after transcatheter aortic valve implantation (TAVI). The cusp-overlap view (COV) was adopted to reduce PPI risk after TAVI with self-expandable valves (SEVs); however, the evidence remains scarce. We performed a systematic review with meta-analysis comparing COV and the standard coplanar view (CPV) technique to evaluate their effectiveness and safety.<br /><b>Methods</b><br />Following the PRISMA statement, data were extracted from studies published by August 2022 and found in PubMed/MEDLINE, EMBASE, CENTRAL/CCTR, ClinicalTrials.gov, SciELO, LILACS, and Google Scholar. The primary outcome of interest was post-procedural PPI and the secondary outcomes were new left bundle branch block (LBBB), moderate/severe paravalvular leak (PVL), valve dislocation (pop-out); need of second transcatheter heart valve, 30-day mortality, stroke, conversion to surgery, coronary obstruction, implantation depth (mm), and post-TAVI mean gradients (mmHg).<br /><b>Results</b><br />Eleven studies met our eligibility criteria and included 1464 patients in the COV group and 1743 patients in the CPV group. Patients who underwent TAVI with COV had lower risk of PPI (odds ratio 0.48; 95% confidence interval [CI] 0.33-0.70; p = 0.001) and higher implantation depths with COV (mean difference -0.83; 95% CI -1.2 to -0.45; p < 0.001). We did not observe any statistically significant differences in the rates of new LBBB, moderate/severe PVL, valve dislocation, need of second transcatheter heart valve, 30-day mortality, stroke, conversion to surgery, coronary obstruction, and post-TAVI mean gradients (mmHg).<br /><b>Conclusion</b><br />In TAVI with SEVs, the application of COV is associated with lower risk of PPI compared with the standard CPV without increasing risk for adverse outcomes.<br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 19 Jan 2023; epub ahead of print</small></div>
Sá MP, Van den Eynde J, Jacquemyn X, Erten O, ... Sicouri S, Ramlawi B
Catheter Cardiovasc Interv: 19 Jan 2023; epub ahead of print | PMID: 36655511
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<div><h4>Long-term follow-up of contemporary drug-eluting stent implantation in diabetic patients: Subanalysis of a randomized controlled trial.</h4><i>van Hemert ND, Voskuil M, Rozemeijer R, Kraaijeveld AO, ... Stella PR, ReCre8 Study Investigators</i><br /><b>Objective</b><br />The elevated risk of adverse events following percutaneous coronary intervention in diabetic patients persists with newer-generation DES. The polymer-free amphilimus-eluting stent (PF-AES) possesses characteristics with a potentially enhanced performance in patients with diabetes. Data from the 1-year follow-up period has been previously published. The aim of this subanalysis was to assess long-term performance of two contemporary drug-eluting stents (DES) in a diabetic population.<br /><b>Methods</b><br />In the ReCre8 trial, patients were stratified for diabetes and troponin status, and randomized to implantation of a permanent polymer zotarolimus-eluting stent (PP-ZES) or PF-AES. The primary endpoint was target-lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction and target-lesion revascularization. Clinical outcomes between discharge and 3 years follow-up were assessed.<br /><b>Results</b><br />A total of 302 patients with diabetes were included in this analysis. After 3 years, TLF occurred in 12.5% of PP-ZES patients versus 10.0% in PF-AES patients (p = 0.46). Similarly, the separate components of TLF were comparable between the two study arms. The secondary composite endpoint of NACE was higher in the PP-ZES arm with 45 cases (29.6%) versus 30 cases (20.0%) in the PF-AES arm (p = 0.036). In the insulin-dependent diabetic population, TLF occurred in 19.1% of PP-ZES patients versus 10.4% of PF-AES patients (p = 0.21). NACE occurred in 40.4% of PP-ZES patients versus 27.1% of PF-AES patients (p = 0.10).<br /><b>Conclusions</b><br />This subanalysis shows that the use of PF-AES results in similar clinical outcomes as compared to PP-ZES, yet some benefits of use of PF-AES in diabetic patients may prevail. Future dedicated trials should confirm these findings.<br /><br />© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 18 Jan 2023; epub ahead of print</small></div>
van Hemert ND, Voskuil M, Rozemeijer R, Kraaijeveld AO, ... Stella PR, ReCre8 Study Investigators
Catheter Cardiovasc Interv: 18 Jan 2023; epub ahead of print | PMID: 36651339
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<div><h4>Leaflet modification or chimney stenting in patients at risk for coronary artery obstruction in valve-in-valve procedure for a failed surgical bioprosthetic aortic valve.</h4><i>Montarello NJ, Quagliana A, Søndergaard L, De Backer O</i><br /><AbstractText>Valve-in-valve transcatheter aortic valve replacement (VIV-TAVR) for a degenerated surgical aortic bioprosthesis is a well-established treatment modality but carries an increased risk of coronary artery obstruction (CAO) with potentially catastrophic consequences. Both chimney stenting and leaflet modification by BASILICA (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Obstruction) are increasingly employed and can be highly effective means of preventing CAO. Using a case report, in which both strategies were utilized, as a platform for detailed discussion, we address the indications, contraindications, and relative merits of each technique in the prevention of CAO.</AbstractText><br /><br />© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 18 Jan 2023; epub ahead of print</small></div>
Montarello NJ, Quagliana A, Søndergaard L, De Backer O
Catheter Cardiovasc Interv: 18 Jan 2023; epub ahead of print | PMID: 36651342
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<div><h4>Transcatheter aortic valve implantation in patients with anomalous coronary artery.</h4><i>Bajoras V, Diečkus L, Wong I, Laurinavičienė A, Davidavičius G, Čėsna S</i><br /><b>Objectives</b><br />The aim of this review was to analyze literature and provide systematic algorithm to guide decision making during TAVI procedure.<br /><b>Background</b><br />Transcatheter aortic valve implantation (TAVI) is growing in popularity and expanding to younger patients with lower risk profiles. Currently, there is no concise guideline on the management strategy during TAVI in patients with anomalous coronary artery (ACA) anatomy undergoing this procedure.<br /><b>Methods</b><br />A systematic search was conducted for relevant case reports of TAVI in patients who had confirmed ACA anatomy. Twenty-four case reports, that met the criteria for this review, were identified and included in the final study size.<br /><b>Results</b><br />TAVI was successful in 23 out of 24 cases. Half of the cases (12) described performing balloon aortic valvuloplasty (BAV) before TAVI. The majority (15) reported using angiogram Postimplantation. Only one-third of cases (8) reported performing coronary protection (with either wire, wire and stent or wire and balloon). Two-third of case reports (16/24, 67%) mentioned using Edwards SAPIEN balloon expandable transcatheter heart valves (THV).<br /><b>Conclusions</b><br />Preprocedural diagnostic imaging tests play important role in determining the ACA anatomy and its relation to the aortic valve. BAV with simultaneous coronary arteries angiography or aortography should be performed before implantation of THV, as it could potentially predict whether the ACA would be compressed. Using at least a coronary wire for ACA protection is recommended in case there is high risk of ACA obstruction. Management strategy should be individualized when performing TAVI in patients with ACA.<br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 14 Jan 2023; epub ahead of print</small></div>
Bajoras V, Diečkus L, Wong I, Laurinavičienė A, Davidavičius G, Čėsna S
Catheter Cardiovasc Interv: 14 Jan 2023; epub ahead of print | PMID: 36640415
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<div><h4>Effect of randomized prophylactic nitroglycerin on radial artery spasm during transradial catheterization: An analysis based on operator experience.</h4><i>da Silva RL, Dangas GD, de Andrade PB, Joaquim RM, ... Feres F, Costa JR</i><br /><AbstractText>One limitation to transradial access (TRA) is the occurrence of spasms (RAS), for which the use of prophylactic medications is recommended. Improvement in TRA material combined with the increase in operators\' expertise, might mitigate this benefit. We assess the effect of preventive nitroglycerin on RAS during TRA, evaluating the role of the operator\'s experience. Patients received 500 μg nitroglycerin or placebo. The operator\'s expertise was classified as: inexperienced (I), intermediate (M), and experienced (E). 2040 patients were included. Prophylactic use of nitroglycerin did not reduce RAS (10.8% vs. 13.4% (placebo), p = 0.07). RAS incidence was 14.5% in I, 12.5% in M, and 9.7% in E (p = 0.01). In group I, nitroglycerin reduced RAS (17.4% vs. 11.1%, p = 0.04), which was not observed in other groups. Overall, nitroglycerin does not prevent RAS, which is more common among inexperienced operators. More experienced operators could abolish preventive nitroglycerin use.</AbstractText><br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 14 Jan 2023; epub ahead of print</small></div>
da Silva RL, Dangas GD, de Andrade PB, Joaquim RM, ... Feres F, Costa JR
Catheter Cardiovasc Interv: 14 Jan 2023; epub ahead of print | PMID: 36640416
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<div><h4>A very rare vascular complication of the Edwards expandable eSheath during transcatheter aortic valve replacement.</h4><i>Savvoulidis P, Nadir AM, Mechery A, Doshi SN</i><br /><AbstractText>Transcatheter aortic valve replacement (TAVR) has revolutionized the management of severe symptomatic aortic valve stenosis. TAVR is now indicated as an alternative to surgical replacement in a wide risk profile ranging from high to low surgical risk. Although vascular complications have decreased in frequency over time, with the introduction of lower profile delivery systems and sheaths, they remain one of the most frequently encountered and serious complications of TAVR. Patient-specific predisposing factors have been well characterized. However, much less is known about device-specific complications. Awareness of the possible device-related complications may lead to earlier identification, prompt management, and better outcomes. We report a previously unreported complication of the Edwards expandable eSheath that lead to avulsion of the external iliac artery following successful TAVR with a 29-mm Edwards Sapien 3 transcatheter heart valve. Bleeding was promptly controlled with an occlusion balloon and emergency surgical repair was required with a favorable outcome.</AbstractText><br /><br />© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 14 Jan 2023; epub ahead of print</small></div>
Savvoulidis P, Nadir AM, Mechery A, Doshi SN
Catheter Cardiovasc Interv: 14 Jan 2023; epub ahead of print | PMID: 36640417
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<div><h4>Timing of sedation and patient-reported pain outcomes during cardiac catheterization: Results from the UNTAP-intervention study.</h4><i>Mall A, Girton TA, Yardley K, Ronn M, ... Jones WS, Granger BB</i><br /><b>Background</b><br />Invasive cardiac catheterization (CC) temporarily increases pain, discomfort, and anxiety. Procedural sedation is deployed to mitigate these symptoms, though practice varies. Research evaluating peri-procedural patient-reported outcomes is lacking.<br /><b>Methods and results</b><br />We randomized 175 patients undergoing CC to short interval ([SI] group, <6 min) or long interval ([LI] group, ≥6 min) time intervals between initial intravenous sedation and local anesthetic administration. Outcomes included: (1) total pain medication use, (2) patient-reported and behaviorally assessed pain and (3) patient satisfaction during outpatient CC. Generalized linear mixed effect models were used to evaluate the impact of treatment time interval on total medication utilization, pain, and satisfaction. Among enrollees the mean age was 62 (standard deviation [SD] = 13.4), a majority were male (66%), white (74%), and overweight (mean body mass index = 28.5 [SD = 5.6]). Total pain medication use did not vary between treatment groups (p = 0.257), with no difference in total fentanyl (p = 0.288) or midazolam (p = 0.292). Post-treatment pain levels and nurse-observed pain were not statistically significant between groups (p = 0.324 & p = 0.656, respectively. No significant differences with satisfaction with sedation were found between the groups (p = 0.95) Patient-reported pain, satisfaction and nurse-observed measures of pain did not differ, after adjustment for demographic and procedural factors. Analyses of treatment effect modification revealed that postprocedure self-reported pain levels varied systematically between individuals undergoing percutaneous coronary intervention (PCI) (SI = 2.2 [0.8, 3.6] vs. LI = 0.7 [-0.6, 2.0]) compared with participants not undergoing PCI (SI = 0.4 [-0.8, 1.7] vs. LI = 0.7 [-0.3, 1.6]) (p = 0.043 for interaction).<br /><b>Conclusion</b><br />No consistent treatment differences were found for total medication dose, pain, or satisfaction regardless of timing between sedation and local anesthetic. Treatment moderations were seen for patients undergoing PCI. Further investigation of how procedural and individual factors impact the patient experience during CC is needed.<br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 14 Jan 2023; epub ahead of print</small></div>
Mall A, Girton TA, Yardley K, Ronn M, ... Jones WS, Granger BB
Catheter Cardiovasc Interv: 14 Jan 2023; epub ahead of print | PMID: 36640418
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<div><h4>Temporary balloon occlusion test can overestimate the risk of acute pulmonary edema after transcatheter atrial septal defect closure.</h4><i>Nakagawa K, Akagi T, Takaya Y, Miki T, ... Morita H, Ito H</i><br /><b>Background</b><br />Atrial septal defect (ASD) closure can cause acute pulmonary edema. Before transcatheter closure is performed, temporary balloon occlusion test (BOT) is recommended in patients with left ventricular dysfunction to predict the risk of pulmonary edema. However, the accuracy of BOT has not been verified. This study aimed to compare hemodynamic differences between BOT and transcatheter closure.<br /><b>Methods</b><br />A total of 42 patients with a single ASD over age 18 years who underwent BOT before transcatheter ASD closure between October 2010 and May 2020 were analyzed. Pulmonary capillary wedge pressure (PCWP) was measured using a Swan-Ganz catheter placed in the pulmonary artery at baseline, after 10 min of BOT, and after transcatheter closure. Amplatzer septal occluder was used for all transcatheter closures.<br /><b>Results</b><br />Mean patient age was 64 ± 18 years (range, 18-78). Mean ASD diameter and pulmonary to systemic flow ratio were 18 ± 5 and 2.8 ± 1.0 mm, respectively. Mean PCWP at baseline, during BOT, and after transcatheter closure was 8.9 ± 2.9, 13.5 ± 4.2, and 9.5 ± 2.6 mmHg, respectively. The difference between BOT and after transcatheter closure values was significant (p < 0.001). During BOT, PCWP increased ≥18 mmHg in 7 patients, whereas after ASD closure, PCWP was <18 mmHg in all 7 and none developed acute pulmonary edema.<br /><b>Conclusion</b><br />Temporary balloon occlusion of an ASD and transcatheter ASD closure result in different hemodynamic change. BOT overestimates increase of PCWP after transcatheter ASD closure and requires careful interpretation. Well-designed, larger studies in higher-risk patients are warranted to verify the clinical implications of BOT in more detail.<br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 14 Jan 2023; epub ahead of print</small></div>
Nakagawa K, Akagi T, Takaya Y, Miki T, ... Morita H, Ito H
Catheter Cardiovasc Interv: 14 Jan 2023; epub ahead of print | PMID: 36640419
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Abstract
<div><h4>Suicide left ventricle following protamine: A case report.</h4><i>Erdem S, An SY, McAlister CA, Basra SS</i><br /><AbstractText>A patient with severe aortic stenosis and left ventricular hypertrophy underwent a transcatheter aortic valve replacement. The patient\'s blood pressure significantly dropped after protamine administration. A diagnosis of suicide left ventricle post-valve replacement was made. The diagnosis and management of the protamine reaction are detailed. This case highlights the need to slowly infuse protamine sulfate and monitor for adverse events.</AbstractText><br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 10 Jan 2023; epub ahead of print</small></div>
Erdem S, An SY, McAlister CA, Basra SS
Catheter Cardiovasc Interv: 10 Jan 2023; epub ahead of print | PMID: 36626268
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Abstract
<div><h4>Ultrasound-guided distal transradial access for cardiac catheterization: Technical notes for the interventionalist.</h4><i>Zuin M, Turchetta S, Drudi A, Gasparetto M, Rubin L, Rigatelli G</i><br /><AbstractText>Over the latest years, the use of distal radial access (dTRA), also called \"snuffbox,\" has become more and more popular for cardiac catheterization. Indeed, dTRA has several advantages compared to the traditional proximal radial approach, such as a lower risk of hand ischemia, radial artery occlusion (RAO) and faster post-procedural hemostasis. However, due to the presence of different muscular-skeletal structures, as well as to the small diameter of the distal radial artery (dRA), an ultrasound-guided cannulation would be preferred since a blind puncture increases the risk of tendon damage and/or the irritation of the underlying periosteum. The present article is aimed to provide the key tips for performing US-guided access using the dRA in patients undergoing percutaneous cardiac procedures.</AbstractText><br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 10 Jan 2023; epub ahead of print</small></div>
Zuin M, Turchetta S, Drudi A, Gasparetto M, Rubin L, Rigatelli G
Catheter Cardiovasc Interv: 10 Jan 2023; epub ahead of print | PMID: 36626276
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<div><h4>Percutaneous heart valves demonstrating long-term durability: A case series of Melody valves in the pulmonary position lasting up to 19 years.</h4><i>MacDonald ST, Bhan A, Khambadkone S, Mullen M</i><br /><AbstractText>It is uncertain how long catheter delivered percutaneous heart valves may last. In congenital cardiology, stenosis and regurgitation of right ventricular to pulmonary artery conduits and valves is common, leading to repeated operations for young patients with concomitant mortality and morbidity. It has also been unclear whether percutaneous pulmonary valves last as long as surgical pulmonary valves. When the current generation of the percutaneous pulmonary valve was first implanted in the United Kingdom from 2003, randomized trials were initially not performed, decided on a case-by-case basis in congenital cardiology, nor long-term registries kept. We describe three cases where such percutaneous heart valves have lasted up to 19 years. All valves were working without significant stenosis and minor degrees of regurgitation on long-term echocardiographic follow-up, patients being asymptomatic. This demonstrates that percutaneous pulmonary valves can achieve long-term durability and may prevent the need for otherwise high-risk surgery in congenital cardiac patients.</AbstractText><br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 10 Jan 2023; epub ahead of print</small></div>
MacDonald ST, Bhan A, Khambadkone S, Mullen M
Catheter Cardiovasc Interv: 10 Jan 2023; epub ahead of print | PMID: 36626279
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Abstract
<div><h4>Improved left atrial appendage closure procedural efficiency using radiofrequency transseptal wire system.</h4><i>Whitler C, McClellan B, Patel H, Rajpurohit D, ... David S, Shah D</i><br /><b>Objective</b><br />The radiofrequency (RF) needle has been shown to improve transseptal puncture efficiency and safety compared to mechanical needles. This study aimed to investigate the use of VersaCross RF transseptal wire system (Baylis Medical) to improve procedural efficiency of left atrial appendage closure (LAAC) compared to the standard RF needle-based workflow.<br /><b>Methods</b><br />Eighty-one LAAC procedures using WATCHMAN FLX were retrospectively analyzed comparing the standard RF needle-based workflow to a RF wire-based workflow. Study primary endpoint was time to WATCHMAN device release, and secondary endpoints were transseptal puncture time, LAAC success, fluoroscopy use, and procedural complications.<br /><b>Results</b><br />Twenty-five cases using standard RF needle-based workflow were compared to 56 cases using the RF wire-based workflow. Baseline patient characteristics were similar between both groups. LAAC was successful in all patients with no differences in intraprocedural complication rates (p = 0.40). Transseptal puncture time was 1.3 min faster using the RF wire-based workflow compared to the standard RF needle-based workflow (6.5 ± 2.3  vs. 7.8 ± 2.3 min, p = 0.02). Overall, time to final WATCHMAN device release was 4.5 min faster with the RF wire-based workflow compared to the RF needle-based workflow (24.6 ± 5.6 vs. 29.1 ± 9.6 min, p = 0.01). Fluoroscopy time was 21% lower using the RF wire-based workflow (7.6 ± 2.8 vs. 9.6 ± 4.4 min; p = 0.05) and fluoroscopy dose was 67% lower (47.1 ± 35.3 vs. 144.9 ± 156.9 mGy, p = 0.04) and more consistent (F-test, p ˂ 0.0001).<br /><b>Conclusions</b><br />The RF wire-based workflow streamlines LAAC procedures, improving LAAC efficiency and safety by reducing fluoroscopy, device exchanges, and delivery sheath manipulation.<br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 10 Jan 2023; epub ahead of print</small></div>
Whitler C, McClellan B, Patel H, Rajpurohit D, ... David S, Shah D
Catheter Cardiovasc Interv: 10 Jan 2023; epub ahead of print | PMID: 36626294
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<div><h4>Feasibility, safety, and efficacy of Atrial Flow Regulator in children under 10 kg.</h4><i>Bautista-Rodriguez C, Hascoët S, Fraisse A</i><br /><b>Introduction</b><br />The Atrial Flow Regulator (AFR) is a new self-expandable percutaneous-delivered fenestrated device providing an interatrial shunt. Its use in pediatric population has been reported in failing Fontan, pulmonary hypertension, or in patients with cardiomyopathy and venoarterial extracorporeal membrane oxygenator (ECMO) support. Its use in small children under 10 kg has not been reported.<br /><b>Methods</b><br />We report the initial single center experience of the AFR implantation in children below 10 kg.<br /><b>Results</b><br />Four children underwent AFR implantation. Patients\' age and weight ranged between 9 and 22 months and 5-8.7 kgs. Indications were to unload the left atrium during ECMO support for end-stage cardiomyopathy and to enlarge a restrictive interatrial shunt in two other patients with complex congenital heart diseases. Devices implanted were AFR-6 and AFR-8. Delivery sheaths used via venous femoral access were undersized and ranged from 9 to 11 Fr. Devices were successfully implanted and provided unrestrictive interatrial shunt in all cases. One child developed a nonocclusive thrombus in the inferior vena cava which resolved within 1 month. Clinical improvement and femoral vein patency were observed in all cases.<br /><b>Conclusion</b><br />AFR implantation is feasible in selected children under 10 kg. The AFR can be safely deployed through sheaths that are 1-2 Fr smaller than the recommended manufacturer size. More studies are needed to confirm safety and efficacy of the device in selected pediatric patients.<br /><br />© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 08 Jan 2023; epub ahead of print</small></div>
Bautista-Rodriguez C, Hascoët S, Fraisse A
Catheter Cardiovasc Interv: 08 Jan 2023; epub ahead of print | PMID: 36617379
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<div><h4>Transcatheter tricuspid valve-in-valve implantation for degenerated surgical bioprosthesis.</h4><i>Chen J, Yang Y, Song W, Feng D, ... Wang C, Wei L</i><br /><b>Background</b><br />Isolated redo surgery for degenerated tricuspid bioprosthesis is of very high risk. We aimed to evaluate the safety and efficacy of transcatheter valve-in-valve (TVIV) implantation using a novel balloon expandable Renato valve.<br /><b>Methods</b><br />A prospective multicenter study was conducted to enroll patients with degenerated tricuspid bioprostheses. A total of 12 patients underwent TVIV implantation using the Renato valve system via transfemoral, transjugular, or transatrial approaches at three institutions from May 2021 to October 2021. All-cause mortality and hemodynamic performance were evaluated up to 6 months after procedure.<br /><b>Results</b><br />The median age was 68.2 years, and 75.0% were female. Six patients had a history of rheumatic left-sided valve surgery and late tricuspid valve replacement. The median preoperative Society of Thoracic Surgeons score was 9.9%. The procedures were successful in all cases. Tricuspid regurgitation and paravalvular leak were none or mild in all patients. The median transvalvular gradient decreased from 7.8 mmHg preoperatively to 4.5 mmHg at 6 months after TVIV, respectively. No death occurred and all patients recovered to New York Heart Association functional class I or II during a 6-month follow-up.<br /><b>Conclusions</b><br />TVIV implantation with the Renato valve was a safe and effective treatment for degenerated bioprostheses in high-risk patients.<br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 08 Jan 2023; epub ahead of print</small></div>
Chen J, Yang Y, Song W, Feng D, ... Wang C, Wei L
Catheter Cardiovasc Interv: 08 Jan 2023; epub ahead of print | PMID: 36617381
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<div><h4>No \"July Effect\" in the management and outcomes of acute myocardial infarction: An 18-year United States national study.</h4><i>Patlolla SH, Truesdell AG, Basir MB, Rab ST, ... Zhao DX, Vallabhajosyula S</i><br /><b>Background</b><br />There has been conflicting reports on the effect of new trainees on clinical outcomes at teaching hospitals in the first training month (July in the United States of America). We sought to assess this \"July effect\" in a contemporary acute myocardial infarction (AMI) population.<br /><b>Methods</b><br />Adult (>18 years) AMI hospitalizations in May and July in urban teaching and urban nonteaching hospitals in the United States were identified from the HCUP-NIS database (2000-2017). In-hospital mortality was compared between May and July admissions. A difference-in-difference analysis comparing a change in outcome from May to July in teaching hospitals to a change in outcome from May to July in nonteaching hospitals was also performed.<br /><b>Results</b><br />A total of 1,312,006 AMI hospitalizations from urban teaching (n = 710,593; 54.2%) or nonteaching (n = 601,413; 45.8%) hospitals in the months of May and July were evaluated. May admissions in teaching hospitals, had greater comorbidity, higher rates of acute multiorgan failure (10.6% vs. 10.2%, p < 0.001) and lower rates of cardiac arrest when compared to July admissions. July AMI admissions had lower in-hospital mortality compared to May (5.6% vs. 5.8%; adjusted odds ratio 0.94 [95% confidence interval 0.92-0.97]; p < 0.001) in teaching hospitals. Using the difference-in-difference model, there was no evidence of a July effect for in-hospital mortality (p = 0.19).<br /><b>Conclusions</b><br />There was no July effect for in-hospital mortality in this contemporary AMI population.<br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 08 Jan 2023; epub ahead of print</small></div>
Patlolla SH, Truesdell AG, Basir MB, Rab ST, ... Zhao DX, Vallabhajosyula S
Catheter Cardiovasc Interv: 08 Jan 2023; epub ahead of print | PMID: 36617382
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<div><h4>Impact of sex on in-hospital mortality and 90-day readmissions in patients undergoing transcatheter mitral valve replacement (TMVR): Analysis from the nationwide readmission database.</h4><i>Ismayl M, Machanahalli Balakrishna A, Elgayesh MM, Thandra A, ... Goldsweig AM, Smer A</i><br /><b>Objectives</b><br />To evaluate sex differences in in-hospital mortality and 90-day readmission rates among patients undergoing transcatheter mitral valve replacement (TMVR) in the United States of America.<br /><b>Background</b><br />Women have higher rates of mortality and rehospitalization than men following many cardiac procedures. TMVR has grown as an alternative to mitral valve surgery for patients at high surgical risk. The rates of TMVR mortality and rehospitalization by sex are unknown.<br /><b>Methods</b><br />We analyzed the Nationwide Readmissions Database (NRD) from 2016 to 2019 to identify hospitalizations for TMVR. Sex differences in in-hospital mortality and 90-day readmissions were determined using logistic regression models.<br /><b>Results</b><br />Between 2016 and 2019, 4109 hospitalizations for TMVR were identified, comprised of 1758 (42.8%) men and 2351 (57.2%) women. The median age was 74 years for both men and women. There was no significant difference in in-hospital mortality during index hospitalization (6.51% vs. 6.69%; p = 0.852) and all-cause 90-day readmission (28.19% vs. 29.59%; p = 0.563) between men and women. Across the study period, trend analysis did not reveal a significant change in in-hospital mortality (men p = 0.087, women p = 0.194) or 90-day readmission rates (men p = 0.569, women p = 0.454).<br /><b>Conclusions</b><br />In patients undergoing TMVR, in-hospital mortality and 90-day readmissions are similar between men and women. Between 2016 and 2019, TMVR in-hospital mortality and 90-day readmission rates remained unchanged. Further research is necessary to confirm these findings.<br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 08 Jan 2023; epub ahead of print</small></div>
Ismayl M, Machanahalli Balakrishna A, Elgayesh MM, Thandra A, ... Goldsweig AM, Smer A
Catheter Cardiovasc Interv: 08 Jan 2023; epub ahead of print | PMID: 36617383
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<div><h4>Success rate and influencing factors of a balloon-push technique: A new technique to remove side branch-jailed struts under three-dimensional optical coherence tomography guidance.</h4><i>Nagoshi R, Kijima Y, Kozuki A, Fujiwara R, ... Higuchi K, Shite J</i><br /><b>Background</b><br />Kissing balloon inflation with distal guide wire recross can cause severe stent deformation depending on the stent link location with respect to the carina. The balloon-push technique, by which an inflated balloon is forced into the SB from the proximal main vessel (MV), is a feasible way to remove jailed struts without causing severe stent deformation.<br /><b>Aims</b><br />We investigated the procedural success rate, patterns of jailed strut removal at side branch (SB) orifices, factors related to failure of jailed strut removal, and follow-up angiogram results of the balloon-push technique.<br /><b>Methods</b><br />Between September 2015 and December 2020, 51 bifurcation stenting cases in which the balloon-push technique was used were enrolled. Based on three-dimensional optical coherence tomography images, strut removal with 1 stent crown length was defined as successful. Strut removal patterns were classified into two types: parallel-slide type (stent struts shifted distally into the MV lumen without inversion) and under-carina type (stent struts shifted distally under the carina with strut inversion or strut slide).<br /><b>Results</b><br />Procedural success was attained in 39 cases (success rate: 76.5%). Parallel-slide type and under-carina type occurred in 43% and 33% of cases, respectively. Factors related to failure were trifurcation lesions and a smaller pushed balloon-SB artery ratio compared with those in success cases (0.95 ± 0.18 vs. 1.10 ± 0.22, p = 0.032). Follow-up angiography was performed in 37 cases, and 2 cases had binary in-stent restenosis.<br /><b>Conclusions</b><br />Removal of jailed struts with the balloon-push technique was feasible, without severe stent deformation, in bifurcation stentings.<br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 08 Jan 2023; epub ahead of print</small></div>
Nagoshi R, Kijima Y, Kozuki A, Fujiwara R, ... Higuchi K, Shite J
Catheter Cardiovasc Interv: 08 Jan 2023; epub ahead of print | PMID: 36617385
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<div><h4>Stingray CART (K14 technique): A novel antegrade dissection reentry strategy.</h4><i>Kalyanasundaram A, Hira RS, Lombardi WL</i><br /><AbstractText>A novel device based CART technique (K14 technique) has been described with 2 case examples to illustrate the same. This CART has been performed after ADR and Reverse-CART were unsuccessful.</AbstractText><br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 08 Jan 2023; epub ahead of print</small></div>
Kalyanasundaram A, Hira RS, Lombardi WL
Catheter Cardiovasc Interv: 08 Jan 2023; epub ahead of print | PMID: 36617386
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<div><h4>\"Power knuckle\" for facilitating the \"move the cap\" technique.</h4><i>Vo MN, Brilakis ES, Lombardi W</i><br /><AbstractText>Chronic total occlusions with proximal cap ambiguity remains the most challenging to recanalize and are associated with higher failure rate. We describe the \"power knuckle\" technique, in which the subintimal space proximal to the proximal cap is safely entered with a knuckle wire supported by a microcatheter and an inflated balloon. The \"power knuckle\" can facilitate entry into the extraplaque space for subsequent antegrade dissection and re-entry.</AbstractText><br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 08 Jan 2023; epub ahead of print</small></div>
Vo MN, Brilakis ES, Lombardi W
Catheter Cardiovasc Interv: 08 Jan 2023; epub ahead of print | PMID: 36617390
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<div><h4>External validation of the PROGRESS-CTO perforation risk score: Individual patient data pooled analysis of three registries.</h4><i>Simsek B, Tajti P, Carlino M, Ojeda S, ... Brilakis ES, Azzalini L</i><br /><b>Background</b><br />Coronary artery perforation is one of the most feared and common complications of chronic total occlusion (CTO) percutaneous coronary intervention (PCI).<br /><b>Methods</b><br />To assess the usefulness of the recently developed PROGRESS-CTO (NCT02061436) perforation risk score in independent cohorts. Individual patient-level data pooled analysis of three registries was performed.<br /><b>Results</b><br />Of the 4566 patients who underwent CTO PCI at 25 centers, 196 (4.2%) had coronary artery perforation. Patients with perforations were older (69 ± 10 vs. 65 ± 10, p < 0.001), more likely to be women (19% vs. 13%, p = 0.009), more likely to have a history of prior coronary artery bypass graft (34% vs. 20%, p < 0.001), and unfavorable angiographic characteristics such as blunt stump (62% vs. 48%, p < 0.001), proximal cap ambiguity (52% vs. 34%, p < 0.001), and moderate-severe calcification (60% vs. 49%, p = 0.002). Technical success was lower in patients with perforations (73% vs. 88%, p < 0.001). The area under the receiver operating characteristic curve of the PROGRESS-CTO perforation risk model was 0.76 (95% confidence interval [CI], 0.72-0.79), with good calibration (Hosmer-Lemeshow p = 0.97). We found that the CTO PCI perforation risk increased with higher PROGRESS-CTO perforation scores: 0.3% (score 0), 2.3% (score 1), 3.1% (score 2), 5.5% (score 3), 7.5% (score 4), 14.6% (score 5).<br /><b>Conclusion</b><br />Given the good discriminative performance, calibration, and the ease of calculation, the PROGRESS-CTO perforation score may facilitate assessment of the risk of perforation in patients undergoing CTO PCI.<br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 08 Jan 2023; epub ahead of print</small></div>
Simsek B, Tajti P, Carlino M, Ojeda S, ... Brilakis ES, Azzalini L
Catheter Cardiovasc Interv: 08 Jan 2023; epub ahead of print | PMID: 36617391
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<div><h4>Intravascular lithotripsy in the treatment of coronary artery calcification in a high-risk real world population.</h4><i>Yeoh J, Kanyal R, Pareek N, Macaya F, ... Hill J, Byrne J</i><br /><b>Background</b><br />The DISRUPT-CAD study series demonstrated feasibility and safety of intravascular lithotripsy (IVL) in selected patients, but applicability across a broad range of clinical scenarios remains unclear.<br /><b>Aims</b><br />This study aims to evaluate the procedural and clinical outcomes of IVL in a high-risk real-world cohort, compared to a regulatory approval cohort.<br /><b>Methods</b><br />Consecutive patients treated with IVL and percutaneous coronary intervention at our center from May 2016 to April 2020 were included. Comparison was made between those enrolled in the DISRUPT-CAD series of studies to those with calcified lesions but an exclusion criteria.<br /><b>Results</b><br />Among 177 patients treated with IVL, 142 were excluded from regulatory trials due to acute coronary syndrome presentation (47.2%), left ventricular ejection fraction <40% (22.5%), chronic renal failure (12.0%), or use of mechanical circulatory support (8.5%). This clinical cohort had a higher SYNTAX score (22.6 ± 12.1 vs. 17.4 ± 9.9, p = 0.019), and more treated ACC/AHA C lesions (56.3% vs. 37.1%, p = 0.042). Rates of device success (93.7% vs. 100.0%, p = 0.208), procedural success (96.5% vs. 100.0%, p = 0.585), and minimal lumen area gain (221.2 ± 93.7% vs. 198.6 ± 152.0%, p = 0.807) were similar in both groups. The DISRUPT-CAD cohort had no in-hospital mortality, 30-day major adverse cardiac events (MACE), or 30-day target vessel revascularization (TVR). The clinical cohort had an in-hospital mortality of 4.2%, 30-day MACE of 7.8%, and 30-day TVR of 1.5%. There was no difference in 12-month TVR (2.9% vs. 2.2%; p = 0.825). Twelve-month MACE was higher in the clinical cohort (21.1% vs. 8.6%, p = 0.03).<br /><b>Conclusion</b><br />IVL use remains associated with high clinical efficacy, procedural success, and low complication rates in a real-world population previously excluded from regulatory approving trials.<br /><br />© 2023 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 08 Jan 2023; epub ahead of print</small></div>
Yeoh J, Kanyal R, Pareek N, Macaya F, ... Hill J, Byrne J
Catheter Cardiovasc Interv: 08 Jan 2023; epub ahead of print | PMID: 36617393
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<div><h4>An algorithmic approach to balloon undilatable coronary lesions.</h4><i>Rempakos A, Kostantinis S, Simsek B, Karacsonyi J, ... Burke MN, Brilakis ES</i><br /><AbstractText>Balloon undilatable lesions are lesions that have been successfully crossed by both a guidewire and a balloon but cannot be expanded despite multiple high-pressure balloon inflations. Balloon undilatable lesions can be de novo or in-stent. We describe a systematic, algorithmic approach to treat both de novo and in-stent balloon undilatable lesions using various techniques, such as high-pressure balloon inflation, plaque modification balloons, intravascular lithotripsy, very high-pressure balloon inflation, coronary atherectomy, laser coronary angioplasty, and extraplaque lesion crossing. Knowledge of the various techniques can increase the efficiency, success and safety of the procedure.</AbstractText><br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 28 Dec 2022; epub ahead of print</small></div>
Rempakos A, Kostantinis S, Simsek B, Karacsonyi J, ... Burke MN, Brilakis ES
Catheter Cardiovasc Interv: 28 Dec 2022; epub ahead of print | PMID: 36579411
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<div><h4>Diagnostic performance of angiography-derived fractional flow reserve in patients with NSTEMI.</h4><i>Skalidis I, Meier D, De Bruyne B, Collet C, ... Muller O, Fournier S</i><br /><b>Unlabelled</b><br />Noninvasive methods of estimating invasively measured fractional flow reserve (FFR<sub>invasive</sub> ) are actively being explored, aiming to avoid the use of an invasive pressure wire and the administration of hyperemia-inducing drugs. Coronary angiography-derived FFR (FFR<sub>angio</sub> ) has already demonstrated its diagnostic performance in the context of stable coronary artery disease. However, its applicability in the context of non-ST-segment elevation myocardial infarction (NSTEMI) has yet to be established. We sought to determine the diagnostic performance of FFR<sub>angio</sub> exclusively in patients presenting with NSTEMI. We performed a prospective, single-center, single-arm, double-blinded study comparing FFR calculated by FFR<sub>angio</sub> to FFR<sub>invasive</sub> in NSTEMI patients. FFR<sub>invasive</sub> was measured in all angiographically intermediate lesions (30%-70% stenosis) and was then compared to FFR<sub>angio</sub> which was calculated at the same position, by a blinded operator. The primary endpoints were the sensitivity and specificity of FFR<sub>angio</sub> for predicting FFR<sub>invasive</sub> using a cut-off value of ≤0.80. Among 100 NSTEMI patients who were screened, 46 patients with 60 vessels in total underwent FFR<sub>invasive</sub> and were included in the study. The mean value of FFR<sub>invasive</sub> was 0.83 ± 0.3 with 22 (36%) being ≤0.80 while the mean FFR<sub>angio</sub> was 0.82 ± 0.1 with 22 (36%) being ≤0.80. FFR<sub>angio</sub> exhibited a sensitivity of 95.5%, a specificity of 97.4%, and a diagnostic accuracy of 96.7%. FFR<sub>angio</sub> can precisely and noninvasively estimate FFR<sub>invasive</sub> in acute coronary syndromes and may have a role in guiding treatment decisions related to angiographically intermediate coronary lesions in this context.<br /><b>What is known</b><br />FFR<sub>angio</sub> has demonstrated its diagnostic performance in validation studies, as a noninvasive and cost-effective method in the context of stable coronary artery disease but its performance has never been exclusively evaluated in NSTEMI patients.<br /><b>What is new</b><br />The present prospective single-center study demonstrates the excellent diagnostic performance of FFR<sub>angio</sub> in detecting functionally significant coronary artery stenosis in the setting of NSTEMI, providing more confidence in utilizing FFR<sub>angio</sub> in this population, avoiding the risk of an invasive pressure wire and the administration of hyperemia-inducing drugs.<br /><b>What is next</b><br />Future randomized trials evaluating FFR<sub>angio</sub> -guided treatment of coronary artery disease (stable or ACS) are now needed to definitively establish the role of FFR<sub>angio</sub> in the physiological assessment of coronary lesions.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 28 Dec 2022; epub ahead of print</small></div>
Skalidis I, Meier D, De Bruyne B, Collet C, ... Muller O, Fournier S
Catheter Cardiovasc Interv: 28 Dec 2022; epub ahead of print | PMID: 36579415
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<div><h4>Suction-based catheter retrieval of right ventricular clot-in-transit.</h4><i>Li LT, Alexis M, Wilson SR, Yu PJ</i><br /><AbstractText>Right ventricular clot-in-transit (CIT) is a rare finding in venous thromboembolic disease and carries a high mortality rate. Its optimal treatments have yet to be established in the literature. Here we describe the usage of a suction-based catheter, the INARI FlowTriever® system (INARI Medical Inc.) to successfully retrieve a CIT from the right ventricle of a patient with coronavirus disease 2019 acute respiratory distress syndrome on veno-veno extracorporeal membrane oxygenation.</AbstractText><br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 27 Dec 2022; epub ahead of print</small></div>
Li LT, Alexis M, Wilson SR, Yu PJ
Catheter Cardiovasc Interv: 27 Dec 2022; epub ahead of print | PMID: 36573416
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<div><h4>Direct oral anticoagulant versus antiplatelet therapy following transcatheter aortic valve replacement in patients without prior or concurrent indication for anticoagulation: A meta-analysis of randomized studies.</h4><i>Barbosa Moreira MJ, Peixoto NADA, Udoma-Udofa OC, de Araújo SLS, Enriquez SKT</i><br /><b>Introduction</b><br />The antithrombotic management following transcatheter aortic valve replacement (TAVR) in patients who do not have a concurrent indication for long-term anticoagulation therapy is an ongoing source of debate.<br /><b>Methods</b><br />We performed a systematic review and meta-analysis to compare direct oral anticoagulants (DOACs) versus antiplatelet therapy after TAVR in patients without a concomitant indication for chronic oral anticoagulation. PubMed, Embase, and Cochrane databases were searched. Only randomized controlled trials were included. Risk ratios (RR) with p < 0.05 were considered statistically significant.<br /><b>Results</b><br />Three studies were included, with 2922 patients who underwent TAVR, of whom 1463 (50.1%) received DOACs. Patients who received DOACs therapy had significantly higher all-cause mortality (RR: 1.68; 95% confidence intervals [CI]: 1.22-2.30; p = 0.001) and non-cardiovascular mortality (RR: 2.33; 95% CI: 1.13-4.80; p = 0.02). The incidence of major bleeding was not significantly different between the groups (5.3% vs. 3.8%; RR: 1.44; 95% CI: 0.90-2.32; p = 0.13). There was no difference between DOACs and antiplatelet therapy in terms of: ischemic stroke (RR: 1.28; 95% CI: 0.76-2.15; p = 0.35) and cardiovascular mortality (RR: 1.36; 95% CI: 0.92-2.03; p = 0.13). Lastly, the DOACs group had a significantly lower risk of valve thrombosis than the antiplatelet group (0.8% vs. 3.2%; RR: 0.27; 95% CI: 0.14-0.51; p < 0.0001).<br /><b>Conclusion</b><br />In this meta-analysis of randomized studies comparing DOACs to antiplatelet therapy after TAVR in patients without a concomitant indication for anticoagulation, DOACs were associated with a lower incidence of valve thrombosis and a higher rate of all-cause mortality, driven by an increase in noncardiac causes of death.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 27 Dec 2022; epub ahead of print</small></div>
Barbosa Moreira MJ, Peixoto NADA, Udoma-Udofa OC, de Araújo SLS, Enriquez SKT
Catheter Cardiovasc Interv: 27 Dec 2022; epub ahead of print | PMID: 36573426
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<div><h4>A 3-year analysis of the impact of COVID-19 pandemic on NSTEMI incidence, clinical characteristics, management, and outcomes.</h4><i>Hyder SA, Schoenl SA, Kesiena O, Ali SH, Davis K, Murrow JR</i><br /><b>Objective</b><br />The COVID-19 pandemic has been associated with decreased incidence of acute coronary syndrome with worsened outcomes. Few studies have addressed the effects beyond the initial phases of the pandemic. This study elucidated the incidence, clinical characteristics, management, and outcomes of NSTEMI at a tertiary referral center from sample time periods of 2019-2022.<br /><b>Methods</b><br />This study included consecutive NSTEMI patients from March 14-May 9, 2019-2022. Variables included baseline characteristics, clinical features on arrival, management strategy, time parameters, and adverse outcomes. The primary outcome was defined as death, heart failure requiring diuretics, and/or sustained ventricular arrhythmia.<br /><b>Results</b><br />This study comprised 250 patients of whom 181 who were admitted during the COVID-19 outbreak. Baseline characteristics were similar among groups. There was a reduction in door-to-angiography time from 29 h in 2019 to 19 h in 2020 [p = 0.01] and 20 h in 2021 [p = 0.02]. PCI intervention increased from 31.8% in 2019% to 50.0% in 2020 [p = 0.05] and 54.7% in 2021 [p < 0.01]. Median length-of-stay (LOS) was reduced from 3 days in 2019 to 2 days in 2020 [p = 0.03]. There was no significant change in outcomes in COVID-19 cohorts compared to control year.<br /><b>Conclusions</b><br />NSTEMI patients during the first 2 years of the COVID-19 pandemic were associated with reduced door-to-angiography times and increased percutaneous coronary intervention (PCI), and patients in year one were associated with reduced LOS. This study suggests that NSTEMI may be managed more efficiently thus reducing hospital bed utilization and potential costs.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 21 Dec 2022; epub ahead of print</small></div>
Hyder SA, Schoenl SA, Kesiena O, Ali SH, Davis K, Murrow JR
Catheter Cardiovasc Interv: 21 Dec 2022; epub ahead of print | PMID: 36542751
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<div><h4>Impact of implantation technique on conduction disturbances for TAVR with the self-expanding portico/navitor valve.</h4><i>Wang X, Wong I, Bajoras V, Vanhaverbeke M, ... De Backer O, Sondergaard L</i><br /><b>Background</b><br />Use of a right-left (R-L) cusp overlap view for transcatheter aortic valve replacement (TAVR) with self-expanding valves has recently been proposed aiming to reduce permanent pacemaker implantation (PPMI). An objective, data-driven explanation for this observation is missing.<br /><b>Aims</b><br />To assess the impact of different implantation techniques on the risk of PPMI following TAVR with the Portico/Navitor<sup>TM</sup> transcatheter heart valve (THV; Abbott).<br /><b>Methods</b><br />A TAVR-population treated with Portico/Navitor<sup>TM</sup> had the THV implanted in a right versus left anterior oblique (RAO/LAO) fluoroscopic view with no parallax in the delivery system. The impact of these different implantation views on the spatial relationship between THV and native aortic annulus and the risk of conduction disturbances and PPMI after TAVR was studied.<br /><b>Results</b><br />A total of 366 matched TAVR patients were studied: 183 in the RAO group and 183 in the LAO group. The degree of aortic annulus plane tilt was significantly smaller in the RAO versus LAO group (median: 0° vs. 23°, p < 0.001), with no plane tilt in 105 out of 183 cases (57.3%) in the RAO group. At 30 days after TAVR, the overall PPMI and guideline-directed PPMI rates were 12.6% versus 18.0% (p = 0.15) and 8.2% versus 15.3% (p = 0.04) in the RAO versus LAO group, respectively.<br /><b>Conclusions</b><br />Use of a R-L cusp overlap (RAO-caudal) view for implantation of the Portico/Navitor<sup>TM</sup> valve results in less tilt of the native aortic annulus plane and a clear trend toward a lower 30-day PPMI rate as compared to TAVR using the conventional LAO implantation view.<br /><br />© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 21 Dec 2022; epub ahead of print</small></div>
Wang X, Wong I, Bajoras V, Vanhaverbeke M, ... De Backer O, Sondergaard L
Catheter Cardiovasc Interv: 21 Dec 2022; epub ahead of print | PMID: 36542648
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<div><h4>Overinflation of balloon-expandable valves for transcatheter treatment of pure noncalcified native aortic regurgitation: How much oversizing is needed and achievable?</h4><i>Orzalkiewicz M, Taglieri N, Palmerini T, Saia F</i><br /><AbstractText>Transcatheter aortic valve implantation (TAVI) in noncalcified pure aortic valve regurgitation is challenging as dedicated valves are not widely available. We present a case series of four inoperable patients who underwent compassionate TAVI for this indication at our institution with a balloon-expandable valve. In this context, we analyzed the relevant technical aspects such as the need for larger oversizing of the transcatheter prosthesis and the safety and limits of valve overexpansion.</AbstractText><br /><br />© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 21 Dec 2022; epub ahead of print</small></div>
Orzalkiewicz M, Taglieri N, Palmerini T, Saia F
Catheter Cardiovasc Interv: 21 Dec 2022; epub ahead of print | PMID: 36542666
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<div><h4>Long-term outcomes following intravascular lithotripsy (IVL) for calcified coronary lesions: A Real-World Multicenter European Study.</h4><i>Basavarajaiah S, Ielasi A, Raja W, Naneishvili T, ... Raju P, Wassef N</i><br /><b>Objectives</b><br />To explore the long-term clinical outcomes following intravascular lithotripsy (IVL) in calcified coronary lesions from a real-world population.<br /><b>Background</b><br />IVL is a relatively new but promising modality for treating coronary calcified lesions, but there is a dearth of long-term outcome data from real-world patients.<br /><b>Methods</b><br />This was a multicenter, observational study in which we enrolled all patients treated with IVL from November 2018 to February 2021 from eight centers in Europe and the United Kingdom. Procedural success, complications, and clinical outcomes (cardiac death, target vessel myocardial infarction [TVMI], target lesion revascularization [TLR], and MACE [major adverse cardiac events, the composite of cardiac death, TVMI, and TLR]) were assessed.<br /><b>Results</b><br />In total, 273 patients with a mean age of 72 ± 9.1 years were treated with IVL. Major comorbidities included diabetes mellitus (n = 110, 40%) and chronic kidney disease (n = 45, 16%). Acute coronary syndrome accounted for 48% (n = 132) of patients, while 52% (n = 141) had stable angina. De novo lesions and in-stent restenosis accounted for 79% and 21% of cases, respectively. Intravascular imaging was used in 33% (n = 90) of patients. An upfront IVL strategy was adopted in 34% (n = 92), while the rest were bailout procedures. Adjuvant rotational atherectomy (\"RotaTripsy\") was required in 11% (n = 31) of cases. The procedural success was 99%. During a median follow-up of 687 days (interquartile range: 549-787), cardiac death occurred in 5% (n = 14), TVMI in 3% (n = 8), TLR in 6% (n = 16), and MACE rate was 11% (n = 30).<br /><b>Conclusion</b><br />This is the largest multicenter registry with a long-term follow-up showing the remarkably high procedural success of IVL use in calcified coronary lesions with low rates of hard endpoints and MACE.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 16 Dec 2022; epub ahead of print</small></div>
Basavarajaiah S, Ielasi A, Raja W, Naneishvili T, ... Raju P, Wassef N
Catheter Cardiovasc Interv: 16 Dec 2022; epub ahead of print | PMID: 36525378
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<div><h4>Continuous mechanical aspiration thrombectomy performs equally well in main versus branch pulmonary emboli: A subgroup analysis of the EXTRACT-PE trial.</h4><i>Leong DW, Ayadi B, Dexter DJ, Rosenberg M, ... Chuang ML, Dohad S</i><br /><b>Introduction</b><br />The EXTRACT-PE trial evaluated the safety and performance of the Indigo Aspiration System (Penumbra Inc.) with an 8F continuous mechanical aspiration thrombectomy system for the treatment of pulmonary embolism (PE). This subgroup analysis evaluates performance outcomes of patients with main pulmonary artery (PA) emboli versus discrete unilateral or bilateral PA emboli without main PA involvement.<br /><b>Methods</b><br />The EXTRACT-PE trial was a prospective, single-arm, multicenter trial that enrolled 119 patients with acute submassive PE. Emboli location was collected at the time of enrollment, CT obstruction was measured and assessed by a Core Lab, and patients were grouped on whether emboli involved the main PA (with or without branch vessels) or not (branch vessels alone). Procedural device time, changes in the right ventricle to left ventricle (RV/LV) ratio, and systolic PA pressure from pre-and posttreatment were compared between the two groups.<br /><b>Results</b><br />Out of the 119 patients enrolled, 118 had core lab-assessed clot locations. Forty-five (38.1%) had emboli that involved the main PA and 73 (61.9%) had only branch emboli. No significant difference was observed between these groups for 30-day mortality, procedural device time, changes in RV/LV ratio, reduction in CT Obstruction Index, or for systolic PA pressure from pre-and posttreatment. The mean absolute reduction in clot burden was significant in both groups.<br /><b>Conclusion</b><br />Continuous mechanical aspiration thrombectomy with the 8F Indigo Aspiration System was effective at improving clinical outcomes for submassive PE patients regardless of emboli location, and clot burden was significantly reduced in both groups.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 16 Dec 2022; epub ahead of print</small></div>
Leong DW, Ayadi B, Dexter DJ, Rosenberg M, ... Chuang ML, Dohad S
Catheter Cardiovasc Interv: 16 Dec 2022; epub ahead of print | PMID: 36525386
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<div><h4>Plaque burden estimated from optical coherence tomography with deep learning: In vivo validation using co-registered intravascular ultrasound.</h4><i>Huang J, Tu S, Masuda S, Ninomiya K, ... Serruys PW, Wijns W</i><br /><b>Objectives</b><br />The objective of the present study was to compare plaque burden (PB) calculated from optical coherence tomography (OCT) using deep learning (DL) with PB derived from co-registered intravascular ultrasound (IVUS).<br /><b>Background</b><br />A DL algorithm was developed for automated plaque characterization and PB quantification from OCT images. However, the performance of this algorithm for PB quantification has not been validated.<br /><b>Methods</b><br />Five-year follow-up OCT and IVUS images from 15 patients implanted with bioresorbable vascular scaffold (BVS) at baseline were analyzed. Precise co-registration for 72 anatomical slices was achieved utilizing unique BVS radiopaque markers. PB derived from OCT DL and IVUS were compared. OCT cross-sections were divided into four subgroups with different media visibility level. The impact of media visibility on the numerical difference between OCT-derived and IVUS-derived PB was investigated. The stent sizes selected by OCT DL and IVUS were compared.<br /><b>Results</b><br />Sixty-four paired OCT and IVUS cross-sections were compared. OCT DL showed good concordance with IVUS for PB assessment (ICC = 0.81, difference = -3.53 ± 6.17%, p < 0.001). The numerical difference between OCT DL-derived PB and IVUS-derived PB was not substantially impacted by missing segments of media visualization (p = 0.21). OCT DL showed a diagnostic accuracy of 92% in identifying PB > 65%. The stent sizes selected by OCT DL were smaller compared to the ones selected by IVUS (difference = 0.30 ± 0.34 mm, p < 0.001).<br /><b>Conclusions</b><br />The DL algorithm provides a feasible and reliable method for automated PB estimation from OCT, irrespective of media visibility. OCT DL showed good diagnostic accuracy in identifying PB > 65%, revealing its potential to complement conventional OCT imaging.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 15 Dec 2022; epub ahead of print</small></div>
Huang J, Tu S, Masuda S, Ninomiya K, ... Serruys PW, Wijns W
Catheter Cardiovasc Interv: 15 Dec 2022; epub ahead of print | PMID: 36519717
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<div><h4>\"Reverse Spider View\" for left stem coronary artery angiographic evaluation.</h4><i>Rigatelli G, Gianese F, Zuin M, Rodino\' G, Marchese G, Pasquetto G</i><br /><AbstractText>Among the angiographic views used to evaluate left coronary system, the so-called \"spider view\" represents one of the most iconic, in particular for its ability to evaluate the Left Main stem (LM) and/or to guide percutaneous coronary interventions (PCIs) on LM bifurcation disease. Unfortunately, the use of such view is graved by a high X-ray exposure for both the operator and the patient. To overcome these limitations, we described an alternative coronary angiographic view, called \"reverse spider\" which is able to give more information about LM body and bifurcation disease with less X-ray exposure for the operator.</AbstractText><br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 13 Dec 2022; epub ahead of print</small></div>
Rigatelli G, Gianese F, Zuin M, Rodino' G, Marchese G, Pasquetto G
Catheter Cardiovasc Interv: 13 Dec 2022; epub ahead of print | PMID: 36511241
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<div><h4>One-year clinical and echocardiographic outcomes of transcatheter aortic valve replacement with SAPIEN 3 Ultra versus SAPIEN 3.</h4><i>Isogai T, Agrawal A, Shekhar S, Spilias N, ... Krishnaswamy A, Kapadia SR</i><br /><b>Background</b><br />The newest-generation balloon-expandable valve, SAPIEN 3 Ultra (S3U), is expected to function well with the enhanced sealing skirt compared with SAPIEN 3 (S3). However, current literature on the comparison between these two valves is limited to short-term follow-ups. Therefore, we aimed to evaluate the 1-year outcomes and echocardiographic changes of S3U compared with S3.<br /><b>Methods</b><br />We retrospectively identified patients who underwent transfemoral-transcatheter aortic valve replacement with S3U or S3 (20/23/26 mm) at our institution in 2018-2020. Outcomes were 1-year clinical events and echocardiographic parameters, and were compared between S3U and S3 after adjustment with inverse probability of treatment weighting.<br /><b>Results</b><br />The S3U and S3 groups included 297 (25.7%) and 858 (74.3%) patients, respectively. There were no significant differences between the two groups in clinical events (death 5.8% vs. 5.5%, hazard ratio [HR] 1.07, 95% confidence interval [CI] 0.81-1.90; death or heart failure hospitalization 10.3% vs. 10.1%, HR 1.04, 95% CI 0.67-1.62). The S3U group had a lower prevalence of mild paravalvular leakage (PVL) (13.7% vs. 22.3%, p = 0.044), with similar moderate PVL (0.7% vs. 1.2%, p > 0.99). No significant differences were observed in aortic valve mean gradient and Doppler velocity index at 1 year. However, the S3U group had a larger increase in mean gradient from implantation to 1 year (median +4.70 vs. +1.63 mmHg, p < 0.001).<br /><b>Conclusions</b><br />S3U and S3 carried similarly favorable clinical event risks. Nonetheless, S3U was associated with less frequent mild PVL but a larger increase in transprosthetic gradient. Further studies are needed to determine the prognostic impact of these hemodynamic differences.<br /><br />© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 13 Dec 2022; epub ahead of print</small></div>
Isogai T, Agrawal A, Shekhar S, Spilias N, ... Krishnaswamy A, Kapadia SR
Catheter Cardiovasc Interv: 13 Dec 2022; epub ahead of print | PMID: 36511393
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<div><h4>Rescue right ventricular outflow tract stenting for refractory hypoxic spells.</h4><i>Sasikumar N, Mohanty S, Balaji S, Kumar RK</i><br /><b>Background</b><br />While right ventricular outflow tract stenting (RVOTS) has become an acceptable alternative to palliative surgery in Tetralogy of Fallot (TOF) and similar physiologies, its utility for relief of refractory hypoxic spells is unclear.<br /><b>Methods</b><br />Patients who underwent RVOTS for emergency relief of refractory hypoxic spells were identified. Specific modifications to enable expeditious RVOTS included use of stent delivery systems (guiding catheter or long sheath) upfront to minimize catheter exchanges; using coronary wires to cross RVOT initially; stabilizing the catheter with a wire in the aorta while crossing RVOT with a second wire.<br /><b>Results</b><br />From 2015 to 2022, 11 patients underwent RVOTS for hypoxic spells refractory to medical management. Their median age was 27 days (IQR 8.5-442.5); weight 3.27 kg (2.7-8.96); 9 males. Median pulmonary annulus Z score was -4.13 (IQR-4.85 to -0.86). Thirteen stents with median diameter 5 (4-6.5) mm and length 19 (16-19.75) mm were implanted, fluoroscopy time:13.6 (11-26.3) min; procedure time (60, 30-70 min). All were ventilated. Oxygen saturations improved from 45% (40-60) to 90% (84-92); (p < 0.0001) with no major complications. Postprocedure ventilation was needed for 21 (20-49) hours and 4 required diuretic infusion for pulmonary over-circulation. Four needed re-stenting 13 days to 5 months later. At median follow-up of 7 (4-17) months; 2 died from unrelated causes, 3 underwent surgery (two correction and one aorto-pulmonary shunt) and 6 await surgery.<br /><b>Conclusion</b><br />RVOTS enables safe, expeditious and effective short-term palliation for refractory hypoxic spells. Specific technical modifications facilitate safety, ease and swiftness.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 13 Dec 2022; epub ahead of print</small></div>
Sasikumar N, Mohanty S, Balaji S, Kumar RK
Catheter Cardiovasc Interv: 13 Dec 2022; epub ahead of print | PMID: 36511421
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<div><h4>Incidence and severity of thrombocytopenia associated with use of intravascular microaxial ventricular assist devices for treatment of cardiogenic shock.</h4><i>Goetz J, O\'Brien M, Bream-Rouwenhorst H, Toyoda A, Hobbs R, Horwitz PA</i><br /><b>Introduction</b><br />The use of temporary mechanical circulatory support (MCS) for patients with refractory cardiogenic shock has increased over the past decade. Impella devices (intravascular microaxial ventricular assist devices [VADs]) have become common MCS options but reportedly cause thrombocytopenia. Limited published data regarding the incidence or severity of microaxial VAD-associated thrombocytopenia exists.<br /><b>Objectives</b><br />The goal of this study was to determine the incidence, timing, and severity of thrombocytopenia in a microaxial VAD population.<br /><b>Methods</b><br />A retrospective multicenter review of electronic medical records identified all patients implanted with microaxial VAD at three US academic teaching hospitals between June 2015 and August 2017. Patients were excluded for short-term procedural microaxial VAD use during percutaneous coronary intervention.<br /><b>Results</b><br />Sixty-four patients underwent microaxial VAD insertion (95% for left-sided support) during the observed time period. Support was in place for a median duration of 5.2 (interquartile range [IQR]: 2.4-10.0) days. Within 7 days postinsertion, 98.5% of patients developed thrombocytopenia (platelet count <150,000/μl) and 81.3% of patients experienced a >50% platelet decrease. Average platelet count nadir was 68,200/μl or 63.9% from baseline occurring on median day 3.8 (IQR: 2.4-5.4). Twenty-four patients (38.1%) were tested for heparin-induced thrombocytopenia by the heparin-dependent antibody (HDA) test. All HDAs were either negative or had serotonin release assay negative confirmation. Postdevice removal, platelet counts returned to baseline or >150,000/μl in 63% of patients by Day 5.<br /><b>Conclusion</b><br />Microaxial VAD-associated thrombocytopenia is common. Practitioners should consider this when evaluating supported patients for other causes of thrombocytopenia. Platelet counts return to preimplantation levels within days of device removal.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 09 Dec 2022; epub ahead of print</small></div>
Goetz J, O'Brien M, Bream-Rouwenhorst H, Toyoda A, Hobbs R, Horwitz PA
Catheter Cardiovasc Interv: 09 Dec 2022; epub ahead of print | PMID: 36490219
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<div><h4>Novel application of intravascular lithotripsy in stent under-expansion: A single-center experience.</h4><i>Hinton J, Mariathas M, Chan E, Patel A, ... Talwar S, O\'Kane P</i><br /><b>Introduction</b><br />Stent under-expansion due to calcification is associated with a less durable result. The development of intravascular lithotripsy (IVL) has provided clinicians with a readily available, simple-to-use treatment option for coronary calcification, but the use of IVL within a previously stented segment is currently off-license. There are, however, developing data suggesting that the use of IVL can be an effective treatment option for patients with calcific stent under-expansion.<br /><b>Method</b><br />This was a single-center study of all patients treated with IVL for calcific stent under-expansion between January 2019 and June 2021. The impact of IVL on quantitative coronary angiography (QCA) stenosis and on the minimal stent area (MSA) derived from intracoronary imaging were recorded. The presence of periprocedural complications and adverse cardiovascular events was obtained from the clinical record during the study timeframe.<br /><b>Results</b><br />Thirty-nine patients underwent IVL for calcific stent under-expansion during the study time frame with one patient treated with more than one lesion in the same session. In all lesions, there was an improvement in the QCA stenosis with 37 (92.5%) having a residual stenosis of ≤30%. The mean QCA stenosis pre-IVL was 68 ± 21% and following IVL the mean QCA was 18 ± 9% (p < 0.001). In all lesions, there was an improvement in the MSA, with 26 (92.9%) achieving an MSA of more than 4.5 mm<sup>2</sup> . The mean MSA pre-IVL was 3.88 ± 1.51 mm<sup>2</sup> and following IVL the mean MSA was 7.41 ± 2.34 mm<sup>2</sup> (p < 0.001). There were no major procedural complications. Over a mean follow-up of 506 ± 277 days, one patient died from ventricular arrhythmia but there were no other major adverse cardiovascular events.<br /><b>Conclusion</b><br />This single-center study demonstrates that IVL is a safe and effective treatment for calcific stent under-expansion with good medium-term results.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 09 Dec 2022; epub ahead of print</small></div>
Hinton J, Mariathas M, Chan E, Patel A, ... Talwar S, O'Kane P
Catheter Cardiovasc Interv: 09 Dec 2022; epub ahead of print | PMID: 36490226
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<div><h4>Short-term dual antiplatelet therapy for 1-3 months after percutaneous coronary intervention using drug eluting stents: A systematic review and meta-analysis of randomized clinical trials.</h4><i>Rout A, Sharma A, Ikram S, Garg A</i><br /><b>Background</b><br />The optimal dual antiplatelet therapy (DAPT) duration and regimen in patients undergoing percutaneous coronary intervention (PCI) using current generation drug eluting stents (DES) is still unclear.<br /><b>Aims</b><br />To compare the safety and efficacy of short-term DAPT (S-DAPT) with longer duration DAPT (l-DAPT) after contemporary PCI.<br /><b>Methods</b><br />We searched for studies comparing S-DAPT (≤3 months) followed by single antiplatelet therapy (SAPT) with aspirin or a P2Y<sub>12</sub> inhibitor against L-DAPT (6-12 months) after PCI with current generation DES. Primary end-points of interest were major bleeding and stent thrombosis (ST) at 1 year. Random-effects meta-analyses were performed to calculate odds ratios with 95% CIs.<br /><b>Results</b><br />Eleven RCTs (n = 48,946) were included in the primary analysis. Major bleeding was significantly lower with S-DAPT (n = 24,424) (odd ratio [OR 0.65; 95% confidence interval, CI 0.52-0.80]) compared with L-DAPT (n = 24,486). There were no differences in ST between the two groups [OR 1.26; 95% CI 0.97-1.63]. There were no significant differences in risks of all-cause death, cardiovascular death or myocardial infarction between S-DAPT and L-DAPT groups. In a subgroup analysis, there was borderline significantly higher ST with 1 month S-DAPT [1.39; 1.0-1.92], but not with 3 months S-DAPT [1.07; 0.70-1.64], when compared to L-DAPT. Finally, there were no significant treatment interactions observed when trials using SAPT with aspirin were compared with those using P2Y<sub>12</sub> inhibitor monotherapy.<br /><b>Conclusion</b><br />Among patients undergoing current generation DES implantation, S-DAPT for 1-3 months reduces major bleeding without an increase in ischemic events compared with L-DAPT. Three months S-DAPT might provide a better risk-benefit profile based on current analysis. Further study is needed to define the SAPT of choice after 1-3 months DAPT.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 09 Dec 2022; epub ahead of print</small></div>
Abstract
<div><h4>Comparison of radiation exposure associated with transradial and transfemoral access: An updated meta-analysis.</h4><i>Saqib N, Pir MS, Rajagopalan S, Patel TM, Pancholy SB</i><br /><b>Objectives</b><br />To assess differences in radiation exposure between transradial access (TRA) and transfemoral access (TFA) for coronary procedures.<br /><b>Background</b><br />TRA is associated with increased radiation exposure as compared to TFA. We compared radiation exposure between the two access sites.<br /><b>Methods</b><br />Databases were searched from June 2014 to August 2021 for randomized controlled trials (RCTs) reporting coprimary outcomes of fluoroscopy time (FT) and/or dose area product (DAP) comparing TRA with TFA. Meta-regression was performed to assess the behavior of weighted mean difference (WMD) in FT from 1995 to 2021. Observational study data was used for corroborative evidence.<br /><b>Results</b><br />Data from 8 RCTs (11,611 patients) showed the WMD of FT was 0.62 min (37 s) (95% confidence interval [CI]: [0.08-1.17], p = 0.023) in favor of TFA, WMD in DAP (9169 patients) was 1.94 Gy.cm<sup>2</sup> (95% CI: [-2.1 to 5.9], p = 0.35) showing no significant difference. Pooled data from OBS and RCTs (83,990 patients) showed a similar trend. Studies from outside US between 1995 and 2021 showed WMD of FT between TRA and TFA of 0.88 min (52 s) (95% CI: [0.67-1.09], p = 0.005) versus 2.1 min (126 s) (95% CI: [1.38-2.8], p = 0.005) for US in favor of TFA. Meta-regression showed a declining WMD of FT between TRA and TFA from 1.6 min (96 s) in 1996 to 0.5 min (30 s) in 2020 with the lower limit of CI crossing the zero line in 2019.<br /><b>Conclusion</b><br />Radiation exposure between TRA and TFA continues to decrease overtime and is becoming clinically nonsignificant.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 09 Dec 2022; epub ahead of print</small></div>
Saqib N, Pir MS, Rajagopalan S, Patel TM, Pancholy SB
Catheter Cardiovasc Interv: 09 Dec 2022; epub ahead of print | PMID: 36490230
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<div><h4>Drug-coated balloon for the treatment of small vessel disease: 9 months of angiographic results and 12 months of clinical outcomes of the PEPCAD China SVD study.</h4><i>Qian J, Wu Y, Li C, Yin J, ... Ge J, PEPCAD China SVD study</i><br /><b>Background</b><br />Whether the drug-coated balloons (DCBs)-alone strategy was superior to plain old balloon angioplasty (POBA) in treating SVD remains unknown.<br /><b>Aims</b><br />We aimed to evaluate the efficacy and safety of DCBs for the treatment of coronary de novo small vessel disease (SVD) and provide further evidence for extending the clinical indications of DCBs. (ChiCTR1800014966).<br /><b>Methods</b><br />Eligible patients were randomized at a 2:1 ratio to receive DCB treatment or POBA in this prospective, multicenter clinical trial. The reference vessel diameter of lesions was visually assessed to be 2.0 to 2.75 mm. The primary endpoint of the study was angiographic in-segment late luminal loss (LLL) at the 9-month follow-up to demonstrate the superiority of DCB treatment to POBA in SVD. The composite clinical endpoints included clinically driven target lesion revascularization (CD-TLR), target lesion failure (TLF), major adverse cardiac events (MACEs), and thrombosis at the 12-month follow-up.<br /><b>Results</b><br />A total of 270 patients were enrolled (181 for DCB, 89 for POBA) at 18 centers in China. The primary endpoint of 9-month in-segment LLL in the intention-to-treat population was 0.10 ± 0.33 mm with DCB and 0.25 ± 0.38 mm with POBA (p = 0.0027). This difference indicated significant superiority of DCB treatment (95% CI: -0.22, -0.04, p<sub>superiority</sub>  = 0.0068). The rates of the clinical endpoints-CD-TLR, TLF, and MACEs-were comparable between groups. No thrombosis events were reported.<br /><b>Conclusions</b><br />DCB treatment of de novo SVD was superior to POBA with lower 9-month in-segment LLL. The rates of clinical events were comparable between the two devices.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 08 Dec 2022; epub ahead of print</small></div>
Qian J, Wu Y, Li C, Yin J, ... Ge J, PEPCAD China SVD study
Catheter Cardiovasc Interv: 08 Dec 2022; epub ahead of print | PMID: 36480798
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<div><h4>Incorporating economic analysis in interventional cardiology research.</h4><i>O\'Byrne ML, Wilensky R, Glatz AC</i><br /><AbstractText>Evaluative research in interventional cardiology has focused on clinical and technical outcomes. Inclusion of economic data can enhance evaluative research by quantifying the relative economic burden incurred by different therapies. When combined with clinical outcomes, cost data can provide a measure of value (e.g., marginal cost-effectiveness). In some select situations, cost data can also be used as surrogates for complexity of care and morbidity. In this narrative review, we aim to provide a framework for the application of cost data in clinical trials and observational research, detailing how to incorporate this kind of data into interventional cardiology research.</AbstractText><br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 08 Dec 2022; epub ahead of print</small></div>
O'Byrne ML, Wilensky R, Glatz AC
Catheter Cardiovasc Interv: 08 Dec 2022; epub ahead of print | PMID: 36480805
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<div><h4>Comparison between the diagnostic performance of vessel fractional flow reserve and nonhyperemic pressure ratio for functionally significant coronary stenosis severity as assessed by fractional flow reserve.</h4><i>Ikeda K, Kobayashi M, Chikamori T, Yanaka Y, ... Hokama Y, Tanaka N</i><br /><b>Background</b><br />Fractional flow reserve (FFR) and nonhyperemic pressure ratios (NHPRs) have been widely used to assess the functional severity of coronary stenosis. However, their measurement requires using a pressure wire, making their use in all patients difficult. The recently developed vessel fractional flow reserve (vFFR), derived from three-dimensional quantitative coronary angiography, is expected to serve as a surrogate for pressure wire assessment.<br /><b>Methods</b><br />This retrospective study was conducted on patients with intermediate coronary stenosis who underwent FFR and NHPR measurements. The vFFR and NHPR values were compared for diagnosing coronary stenosis as defined by an FFR of ≤0.80, and the number of patients not requiring wire-based assessment was estimated.<br /><b>Results</b><br />In a total of 90 lesions from 74 patients (median [SD] age 75 [12] years; men 80%), the median FFR was 0.78 (0.72-0.84), and 57% of these lesions (N = 51) exhibited an FFR of ≤0.80. vFFR provided high discrimination for coronary stenosis (area under the curve 0.80, 95% confidence interval 0.70-0.90), which was comparable to that of NHPRs (p = 0.42). High diagnostic accuracy was consistently observed across a variety of clinical presentations (i.e., old age, diabetes, target coronary artery, and left ventricular hypertrophy) (p<sub>interaction</sub>  > 0.05). In total, 55 lesions (61%) demonstrated positive or negative likelihood of coronary stenosis when vFFR was <0.73 (specificity 90%) or >0.87 (sensitivity 88%), respectively.<br /><b>Conclusion</b><br />vFFR demonstrated excellent diagnostic performance for detecting functionally significant coronary stenosis as evaluated by FFR. vFFR may be used as a surrogate for pressure wire assessment.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 08 Dec 2022; epub ahead of print</small></div>
Ikeda K, Kobayashi M, Chikamori T, Yanaka Y, ... Hokama Y, Tanaka N
Catheter Cardiovasc Interv: 08 Dec 2022; epub ahead of print | PMID: 36480810
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Abstract
<div><h4>Radial and ulnar approach for carotid artery stenting with Roadsaver™ double layer micromesh stent: Early and long-term follow-up.</h4><i>Petkoska D, Zafirovska B, Vasilev I, Novotni G, Bertrand OF, Kedev S</i><br /><b>Aims</b><br />We aimed to evaluate the feasibility and safety of carotid artery stenting (CAS) with a newly designed double-layer micromesh stent using wrist approach in patients with significant carotid disease.<br /><b>Materials and methods</b><br />Between January 2016 and December 2021, 105 patients undergoing CAS with Roadsaver™ stent were enrolled in a single center prospective study. Follow-up assessments included neurological exams, duplex ultrasound (DUS), and 12-lead ECG. The primary endpoint was the 30-day composite rate of stroke, death, and myocardial infarction. Secondary endpoints included procedure success, access site complications, device success, target lesion revascularization, and in-stent restenosis evaluated with DUS. Long-term outcomes up to 72 months of follow-up were assessed in all eligible patients.<br /><b>Results</b><br />The study population was predominantly male (69.5%) with a median age of 68 ± 8 years. Patients were symptomatic in 80% of the cases, and 35% fulfilled the high-risk criteria for surgical endarterectomy. The right internal carotid artery was the target artery in 56 (53.4%), and the left in 49 (46.6%) of the cases. All procedures were successfully completed from the right wrist, with right radial access in 94 (89.5%) cases and ulnar artery access with previous radial artery occlusion in 11 (10.5%) cases. All patients were treated successfully with the study device. The primary endpoint was met with a 30-day major adverse event rate of 0.9% (1/105). Up to 72 months of follow-up (median 30 ± 20 months) there were no strokes, neurological deaths, or target lesion revascularization of the treated lesion. Doppler ultrasound examination revealed nonsignificant in-stent restenosis in two asymptomatic patients. There was no hand ischemia detected in any patient.<br /><b>Conclusion</b><br />Results from this study demonstrate the radial and ulnar access for CAS with double layer micromesh Roadsaver™ stent is safe and feasible and associated with favorable early and long-term follow-up.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 07 Dec 2022; epub ahead of print</small></div>
Petkoska D, Zafirovska B, Vasilev I, Novotni G, Bertrand OF, Kedev S
Catheter Cardiovasc Interv: 07 Dec 2022; epub ahead of print | PMID: 36478513
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<div><h4>Single arterial access closure of post-infarction ventricular septal defect: A case series.</h4><i>Doost A, Chilmeran A, Gomes A, Dworakowski R, ... Byrne J, Hildick-Smith D</i><br /><b>Background</b><br />Post-infarction ventricular septal defect (PIVSD) carries a very poor prognosis. Surgical repair offers reasonable outcomes in patients who survive the initial healing period. Percutaneous device implantation remains a potentially effective earlier alternative.<br /><b>Methods and results</b><br />From March 2018 to May 2022, 11 trans-arterial PIVSD closures were attempted in 9 patients from two centers (aged 67.2 ± 11.1 years; 77.8% male). Two patients had a second procedure. Myocardial infarction was anterior in four patients (44.5%) and inferior in five cases (55.5%). Devices were successfully implanted in all patients. There were no major immediate procedural complications. Immediate shunt grade postprocedure was significant (11.1%), minimal (77.8%), or none (11.1%). Median length of stay after the procedure was 14.8 days. Five patients (55%) survived to discharge and were followed up for a median of 605 days, during which time no additional patients died.<br /><b>Conclusion</b><br />Single arterial access for percutaneous closure of PIVSD is a good option for these extremely high-risk patients, in the era of effective large-bore arterial access closure. Mortality remains high, but patients who survive to discharge do well in the longer term.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 07 Dec 2022; epub ahead of print</small></div>
Doost A, Chilmeran A, Gomes A, Dworakowski R, ... Byrne J, Hildick-Smith D
Catheter Cardiovasc Interv: 07 Dec 2022; epub ahead of print | PMID: 36478105
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<div><h4>Readmission with infective endocarditis within 90 days following transcatheter aortic valve implantation.</h4><i>Ogami T, Kliner DE, Toma C, Serna-Gallegos D, ... Yousef S, Sultan I</i><br /><b>Introduction</b><br />Transcatheter aortic valve implantation (TAVI) continues to be the most common modality of treating aortic stenosis in the United States. While infective endocarditis (IE) and its outcomes have been well documented after surgical aortic valve replacement, the incidence and outcomes of early IE after TAVI have not been well described.<br /><b>Methods</b><br />All patients who underwent TAVI from 2012 through 2018 were identified using the National Readmission Database. Among them, patients who underwent TAVI at the index admission and readmitted within 90 days were included. Patients who died or had IE during the index admission were excluded. Clinical outcomes were compared between patients readmitted with IE (IE group) and those without (non-IE group).<br /><b>Results</b><br />A total of 168,283 patients were readmitted to a hospital within 90 days after TAVI. The median age of the IE group and non-IE group were 81 and 82 years old, respectively (p = 0.21). Of those, 525 (0.3%) were readmitted with IE. The median time from TAVI to readmission was 20 days. During readmissions, 11.6% of the IE group died while only 3.15% of the non-IE group experienced death (p < 0.001). The most common causative organism of IE was enterococcus (22.1%). Multivariable analysis revealed that congestive heart failure, cerebrovascular disease, dialysis, concomitant valve disease, Medicaid, and discharge to a facility were independently associated with readmission with IE within 90 days.<br /><b>Conclusion</b><br />The incidence of readmission with IE is low after TAVI. However, the mortality was markedly high during readmissions. Surgical intervention was rarely performed for IE during the first admission. Enterococcus was the most common organism observed in IE after TAVI.<br /><b>Disclosure</b><br />IS receives institutional research support from Abbott, Atricure, cryolife, and Medtronic. None related to this manuscript.<br /><b>Clinical trial registration</b><br />Not applicable.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 07 Dec 2022; epub ahead of print</small></div>
Ogami T, Kliner DE, Toma C, Serna-Gallegos D, ... Yousef S, Sultan I
Catheter Cardiovasc Interv: 07 Dec 2022; epub ahead of print | PMID: 36478377
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<div><h4>Minimalist transcatheter aortic valve replacement misses paravalvular regurgitation: Incidence and echocardiographic distribution of missed paravalvular regurgitation.</h4><i>Zaid S, Haniyeh AA, Rosenzveig A, Malik A, ... Tang GHL, Ahmad H</i><br /><b>Background</b><br />Paravalvular regurgitation (PVR) may be missed intraoperatively with transthoracic echocardiography (TTE) guided minimalist TAVR. We sought to determine the incidence and echocardiographic distribution of PVR missed on intra-op TTE, but detected on predischarge TTE.<br /><b>Methods</b><br />From July 2015 to 2020, 475 patients with symptomatic severe native aortic stenosis underwent TTE-guided minimalist TAVR. Missed PVR was defined as predischarge PVR that was ≥1 grade higher than the corresponding intra-op PVR severity. PVR was classified as anterior or posterior on the four standard TTE views; parasternal short-axis (PSAX), parasternal long-axis (PLAX), apical 3-chamber (A3C), and 5-chamber (A5C). Location-specific risk of missed PVR was then determined.<br /><b>Results</b><br />Mild or greater PVR was seen in 55 (11.5%) cases intra-op and 91 (19.1%) at predischarge, with no severe PVR. Among the 91 patients with ≥mild predischarge PVR, missed PVR was present in 42 (46.2%). Compared to the corresponding anterior jets, missed PVR rate was significantly higher for posterior jets in PLAX (62.5% vs. 25.0%, p = 0.005), A5C (56.9% vs. 25.0%, p = 0.009), PSAX (66.7% vs. 24.3%, 0.001), but not A3C (58.5% vs. 40.0%, p = 0.28).<br /><b>Conclusions</b><br />Intraoperative TTE-guided minimalist TAVR either misses nearly half of ≥mild PVR or underestimates PVR by ≥1 grade when compared to predischarge TTE. Posterior PVR jets are more likely to be missed. Transesophageal echo guidance may help minimize missing PVR. Further studies are warranted.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 07 Dec 2022; epub ahead of print</small></div>
Zaid S, Haniyeh AA, Rosenzveig A, Malik A, ... Tang GHL, Ahmad H
Catheter Cardiovasc Interv: 07 Dec 2022; epub ahead of print | PMID: 36478154
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<div><h4>Aortic annulus ellipticity and outcomes after transcatheter aortic valve implantation.</h4><i>Tomii D, Okuno T, Lanz J, Stortecky S, Windecker S, Pilgrim T</i><br /><b>Background</b><br />Elliptical shape of the aortic annulus has been associated with an increased risk of device failure after transcatheter aortic valve implantation (TAVI) compared with a circular annular shape.<br /><b>Aims</b><br />To assess the impact of annulus ellipticity on procedural outcomes and device performance in patients undergoing TAVI.<br /><b>Methods</b><br />In a prospective TAVI registry, aortic annulus ellipticity was assessed by preprocedural multidetector computed tomography. The annulus ratios, defined by the ratio of minimum and maximum annulus diameters measured in a transverse double oblique plane, were split into tertiles for comparisons between groups.<br /><b>Results</b><br />A total of 1732 patients undergoing TAVI between August 2007 and June 2020 were included in the present analysis. Patients in the tertile with the most elliptical shape of the annulus were more likely to be female (59.7% vs. 47.9%; p < 0.001) and had a higher Society of Thoracic Surgeons Predicted Risk of Mortality (5.4 ± 3.8 vs. 4.8 ± 3.5; p = 0.002). There were no significant differences in the rate of technical success (95.3% vs. 96.5%; p = 0.235), device success (83.6% vs. 86.5%; p = 0.118) and intended valve performance (90.7% vs. 91.7; p = 0.503) between patients in the most elliptical tertile and the rest. However, valve dislocation/embolization occurred more frequently in patients with elliptical as compared to circular annular shape (2.6% vs. 1.2%; p = 0.046).<br /><b>Conclusions</b><br />Ellipticity of the aortic annulus does not affect procedural and device outcomes in patients undergoing TAVI irrespective of transcatheter heart valve design and generation. https:www.//clinicaltrials.gov. NCT01368250.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 01 Dec 2022; epub ahead of print</small></div>
Tomii D, Okuno T, Lanz J, Stortecky S, Windecker S, Pilgrim T
Catheter Cardiovasc Interv: 01 Dec 2022; epub ahead of print | PMID: 36453455
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<div><h4>A novel comprehensive radiation shielding system eliminates need for personal lead aprons in the catheterization laboratory.</h4><i>Rabah M, Allen S, Abbas AE, Dixon S</i><br /><b>Objectives</b><br />This clinical study evaluated the efficacy of a novel radiation shielding system for the cardiac catheterization laboratory designed to provide comprehensive protection that obviates the need for personal lead aprons.<br /><b>Background</b><br />Invasive Cardiologists are exposed to occupational health hazards related directly to radiation exposure (RE) and indirectly to the orthopedic burden of wearing only partially protective lead aprons. Innovations to reduce these risks are warranted. A novel comprehensive shielding system (Protego<sup>TM</sup> , Image Diagnostics Inc, Fitchburg, Ma) has been validated in pre-clinical studies to provide excellent radiation protection, sufficient for the State of Michigan to certify it for use without need for personal lead aprons.<br /><b>Methods</b><br />This clinical analysis measured RE to a single Physician operator utilizing the Protego<sup>TM</sup> shield (and not wearing personal lead apron) during routine cardiac catheterization procedures (diagnostic and interventional). RE was measured at both thyroid and waist level with a real-time dosimetry system (Raysafe<sup>TM</sup> , Billdal, Sweden), calculated on a median per case basis (mrems). Additional parameters collected included procedure type, access site, per case fluoroscopy time, and patient factors including body mass index.<br /><b>Results</b><br />In n=98 cases (25% diagnostic, 75% interventional including 22% chronic total occlusions), median/case RE was 0.4 mrems (thyroid) and 0.2 mrems (waist). RE=0 in 12 cases. In no case did radiation exposure exceed 3.2 mrems.<br /><b>Conclusion</b><br />The Protego<sup>TM</sup> shield system provides excellent RE protection to the Physician operator, without the need for personal lead aprons and has the potential to reduce catheterization laboratory occupational health hazards.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 01 Dec 2022; epub ahead of print</small></div>
Rabah M, Allen S, Abbas AE, Dixon S
Catheter Cardiovasc Interv: 01 Dec 2022; epub ahead of print | PMID: 36453459
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<div><h4>Mechanical thrombectomy versus catheter directed thrombolysis in patients with pulmonary embolism: A multicenter experience.</h4><i>Inci EK, Khandhar S, Toma C, Licitra G, ... Bashline M, Jaber WA</i><br /><b>Objectives</b><br />Compare in-hospital outcomes of patients treated with either mechanical thrombectomy (MT) or catheter directed lysis (CDL) in treatment of acute pulmonary embolism (PE).<br /><b>Methods</b><br />This is a multicenter, retrospective cohort study of patients undergoing MT or CDL for acute PE between 2014 and 2021. The primary outcome was the composite of in-hospital death, significant bleed, vascular complication, or need for mechanical support post-procedure. Secondary outcomes included the individual components of the composite outcome in addition to blood transfusions, invasive hemodynamics, echocardiographic data, and intensive care unit (ICU) utilization.<br /><b>Results</b><br />458 patients were treated for PE with 266 patients in the CDL arm and 192 patients in the MT arm. The primary composite endpoint was not significantly different between the two groups with CDL 12% versus MT 11% (p = 0.5). There was a significant difference in total length of ICU time required with more in the CDL group versus MT (3.8 ± 2.0 vs. 2.8 ± 3.0 days, p = 0.009). All other secondary end points showed no significant difference between the groups.<br /><b>Conclusions</b><br />In patients undergoing catheter directed treatment of PE, there was no difference between MT and CDL in terms of in-hospital mortality, bleeds, catheter-related complications, and hemodynamics.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 30 Nov 2022; epub ahead of print</small></div>
Inci EK, Khandhar S, Toma C, Licitra G, ... Bashline M, Jaber WA
Catheter Cardiovasc Interv: 30 Nov 2022; epub ahead of print | PMID: 36448401
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<div><h4>Hybrid approach for harmony transcatheter pulmonary valve replacement.</h4><i>Shibbani K, Aboulhosn J, Levi D, Mohammad Nijres B, ... Van Arsdell G, Aldoss O</i><br /><AbstractText>The Harmony™ Transcatheter Pulmonary Valve (Medtronic) was recently approved by the Food and Drug Administration for transcatheter pulmonary valve replacement in native right ventricular outflow tracts. Despite this milestone, some patients have main pulmonary arteries that are severely dilated and continue to require surgical pulmonary valve replacement. The hybrid approach combines surgical creation of a landing zone, transcatheter valve deployment, and suture stabilization of the implanted valve. In this case series, we report the first use of a hybrid approach for Harmony™ transcatheter pulmonary valve replacement. Two cases are reported with varying approaches for surgical creation of a landing zone followed by successful placement of a Harmony™ valve.</AbstractText><br /><br />© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 26 Nov 2022; epub ahead of print</small></div>
Shibbani K, Aboulhosn J, Levi D, Mohammad Nijres B, ... Van Arsdell G, Aldoss O
Catheter Cardiovasc Interv: 26 Nov 2022; epub ahead of print | PMID: 36434791
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<div><h4>Frequency and outcomes of STEMI patients presenting between 12 and 24 h after symptom onset: Late-presenting STEMI.</h4><i>Griffin ACG, Yildiz M, Bradley S, Smith JE, ... Sharkey SW, Henry TD</i><br /><b>Objectives</b><br />To assess the characteristics and prognosis of ST-elevation myocardial infarction (STEMI) patients, presenting between 12 and 24 h after symptom onset, in contemporary regional STEMI systems of care in the United States.<br /><b>Background</b><br />Previous observational studies have been inconsistent regarding the benefit of primary percutaneous coronary intervention (PCI) compared with conservative management for late-presenting STEMI patients and the majority of randomized trials are from the fibrinolytic era.<br /><b>Methods</b><br />Using a two-center registry-based cohort from March 2003 to December 2020, we evaluated the frequency, clinical characteristics, and outcomes of STEMI patients, stratified by symptom onset to balloon time: <3, 3-6, 6-12, and 12-24 h (late presenters).<br /><b>Results</b><br />Among 5427 STEMI patients with available symptom onset time, 6.2% were late presenters, which increased to 11% during the early phase of the Covid-19 pandemic. As symptom onset to balloon time increased, patients were more likely to be older, female, and have a history of hypertension and diabetes mellitus. Late presenters with an identifiable culprit lesion were less likely to be revascularized with PCI (96%, 96%, 95%, and 92%; p for trend = 0.004) and had a longer median door-to-balloon time (82, 109, 107, and 117 min; p for trend < 0.001). In-hospital and 1-year death risks were comparable between late and earlier presenters.<br /><b>Conclusion</b><br />Despite the unfavorable risk profile and longer door-to-balloon time, clinical outcomes of late presenters were similar to those presenting within 12 h of symptom onset.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 24 Nov 2022; epub ahead of print</small></div>
Griffin ACG, Yildiz M, Bradley S, Smith JE, ... Sharkey SW, Henry TD
Catheter Cardiovasc Interv: 24 Nov 2022; epub ahead of print | PMID: 36423258
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Abstract
<div><h4>A word of caution: Early failure of Magmaris® bioresorbable stent after pulmonary artery stenting.</h4><i>Haddad RN, Adel Hassan A, Al Soufi M, Kasem M</i><br /><AbstractText>Bioresorbable scaffolds (BRS) have been advocated as the fourth revolution in interventional cardiology medical devices with promising technology to improve the treatment of coronary artery disease with an event-free future. We describe the first reported use and early collapse of the Magmaris® Resorbable Magnesium Scaffold (RMS) stent (BIOTRONIK AG, Switzerland) to relieve left pulmonary artery severe stenosis in a newborn after the Norwood procedure. The stent collapse was detected 2 weeks after implantation and urgently treated with a balloon-expandable stent. This complication raises the alarm about the need to keep implanted RMS under scrutiny. The possibility of faster scaffold resorption in small babies or lack of sufficient radial force of RMS to resist acute vessel recoil has led to ineffective relief of branch pulmonary artery stenosis and failure to enable a safe short-term bridge to Stage II palliation.</AbstractText><br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 22 Nov 2022; epub ahead of print</small></div>
Haddad RN, Adel Hassan A, Al Soufi M, Kasem M
Catheter Cardiovasc Interv: 22 Nov 2022; epub ahead of print | PMID: 36413609
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<div><h4>Procedural simplification of left atrial appendage occlusion using the VersaCross connect system: First in-human experience.</h4><i>Perrin N, McAlister C, Tsang M, Mondésert B, Ibrahim R, Saw J</i><br /><b>Background</b><br />Left atrial appendage occlusion (LAAO) has emerged over the last two decades as an efficient and safe alternative to oral anticoagulation for stroke prevention. However, LAAO remains challenging due to the variety of anatomies and the multiple steps required to complete the procedure.<br /><b>Aims</b><br />We report the first series of in-human experience of the new all-in-one VersaCross Connect system designed to access the left atrium in conjunction with the delivery sheath for deployment of the WATCHMAN FLX device.<br /><b>Methods</b><br />We prospectively included the first nine consecutive cases of LAAO using the new VersaCross Connect system for WATCHMAN FLX device implantation at the Montreal Heart Institute and Vancouver General Hospital and collected procedural duration (defined as time from femoral access to closure) and time from transseptal puncture to device delivery.<br /><b>Results</b><br />VersaCross Connect system use for WATCHMAN FLX implantation was successful in all patients. No procedural complication was reported. Mean procedural time was 31 ± 6.3 min with a fluoroscopy time of 6.7 ± 4.9 min. The mean delay between the transseptal puncture and device implantation was 12.2 ± 1.9 min.<br /><b>Conclusions</b><br />We showed that the VersaCross Connect system was safe and successfully used in all first nine cases. This new system helped improve the efficiency of the procedure.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 22 Nov 2022; epub ahead of print</small></div>
Perrin N, McAlister C, Tsang M, Mondésert B, Ibrahim R, Saw J
Catheter Cardiovasc Interv: 22 Nov 2022; epub ahead of print | PMID: 36413620
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<div><h4>Multimodality imaging results of TAP versus novel modified TAP stenting in coronary bifurcation: From bench testing to first-in-man investigation.</h4><i>Ng JCK, Ang H, Zhong L, Hakim D, ... Foin N, Leesar MA</i><br /><b>Objectives</b><br />We investigated the results of T and small protrusion (TAP) versus a novel modification of TAP (mTAP) stenting by multimodality imaging in bench testing and in patients with coronary bifurcation lesions (CBL).<br /><b>Background</b><br />TAP stenting is a suboptimal technique for bailout side branch (SB) stenting.<br /><b>Methods</b><br />In a bench model, optical coherence tomography (OCT), microscopic examinations (ME), and computational fluid dynamics (CFD) were performed after TAP and mTAP stenting. In 20 patients with CBL, 80 intravascular ultrasound (IVUS) examinations were performed during mTAP stenting in which the SB stent was pulled-back to indent the inflated main vessel (MV) balloon and deployed while deflating it. For TAP stenting, the tip of the SB stent was positioned in the MV and deployed.<br /><b>Results</b><br />In bench testing, OCT showed neocarina length (NL) was shorter and minimum stent area (MSA) was larger after mTAP versus TAP stenting (2.84 ± 0.70 vs. 4.80 ± 020 mm; 6.75 ± 1.50 vs. 4.5 ± 2.2 mm<sup>2</sup> ; respectively; p < 0.05). By ME, NL was shorter and shear rate trended lower after mTAP versus TAP stenting. In patients, IVUS showed MSA was larger after versus before mTAP stenting (6.32 ± 0.58 vs. 5.21 ± 0.56 mm<sup>2</sup> ; p < 0.01); NL was 1.43 ± 0.22 mm with SB ostium coverage. The Seattle Angina questionnaire (SAQ) score was higher at 6 months versus baseline (85 ± 4.0 vs. 48 ± 6.0, respectively; p < 0.001).<br /><b>Conclusions</b><br />This multimodality imaging study showed, for the first time, mTAP stenting resulted in larger stent area and shorter neocarina than TAP stenting in bench testing. In patients with CBL, mTAP stenting led to larger stent area, short neocarina with complete SB ostium coverage, and improved the SAQ score at follow-up.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 20 Nov 2022; epub ahead of print</small></div>
Ng JCK, Ang H, Zhong L, Hakim D, ... Foin N, Leesar MA
Catheter Cardiovasc Interv: 20 Nov 2022; epub ahead of print | PMID: 36403271
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<div><h4>Management of a right coronary artery mycotic coronary aneurysm with percutaneous intervention with covered stents.</h4><i>Price J, Okyere R, Al-Kindi S, Gupta A</i><br /><AbstractText>Coronary artery aneurysmal dilation is a rare finding with poorly understood mechanism of action that is found in small population of patients undergoing coronary angiography. Mycotic coronary aneurysm is an even rarer cause of coronary aneurysmal dilatation that develops as a potentially fatal complication of bacteremia. We present a case of mycotic right coronary artery aneurysm in a nonsurgical candidate with complex medical comorbidities treated with percutaneous coronary intervention via covered stents.</AbstractText><br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 20 Nov 2022; epub ahead of print</small></div>
Price J, Okyere R, Al-Kindi S, Gupta A
Catheter Cardiovasc Interv: 20 Nov 2022; epub ahead of print | PMID: 36403280
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<div><h4>Correlation of aortic valve annular plane assessment by on-table three-dimensional rotational angiography and preprocedural computed tomography.</h4><i>Tanner R, Murphy S, Malone C, McGorrian C, ... Margey R, Casserly IP</i><br /><b>Objectives</b><br />To assess the correlation between the aortic valve annular plane (AVAP) obtained by preprocedural computed tomography (CT) with on-table three-dimensional rotational angiography (3DRA), in patients undergoing transcatheter aortic valve replacement (TAVR).<br /><b>Background</b><br />Accurate assessment of the AVAP is critical during TAVR procedures to enable optimal positioning and minimize complications. Most commonly, preprocedural CT has been used to determine the AVAP. However, this can differ from the actual AVAP obtained during the TAVR procedure.<br /><b>Methods</b><br />Consecutive TAVR patients at a single center undergoing both preprocedural CT and 3DRA were included in the study. The AVAP assessment by CT was performed using 3mensio software (Pie Medical Imaging). 3DRA assessment was performed using DynaCT (Siemens).<br /><b>Results</b><br />A total of 100 patients were included in the analysis. A difference of ≥5° and ≥10° in both the LAO/RAO and cranial/caudal components of the AVAP projection angle as assessed by CT and 3DRA was recorded in 39% and 10% of patients, respectively. The concordance correlation coefficient for the LAO/RAO and cranial/caudal implantation angles was 0.519 (95% CI: 0.377-0.661) and 0.558 (95% CI: 0.432-0.684), respectively.<br /><b>Conclusion</b><br />Correlation between preprocedural CT and on-table 3DRA in the prediction of the actual AVAP at the time of TAVR implantation is moderate.<br /><br />© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 20 Nov 2022; epub ahead of print</small></div>
Tanner R, Murphy S, Malone C, McGorrian C, ... Margey R, Casserly IP
Catheter Cardiovasc Interv: 20 Nov 2022; epub ahead of print | PMID: 36403283
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<div><h4>Long-term outcomes after paclitaxel-coated balloon angioplasty of femoropopliteal arteries in Asian patients of the IN.PACT Global Study.</h4><i>Ko YG, Choi D, Rha SW, Won JH, ... Menk JS, Kum S</i><br /><b>Objectives</b><br />The long-term data on the use of drug-coated balloons (DCBs) for femoropopliteal atherosclerotic lesions in the real-world setting are limited, even more so for racially and geographically distinct populations. The present analysis reports the 5-year safety and effectiveness outcomes of a DCB in the Asian subset of the prospective, real-world IN.PACT Global Study.<br /><b>Methods</b><br />The IN.PACT Global Study was a prospective, multicenter, international, single-arm study designed to assess the long-term safety and effectiveness of the IN.PACT Admiral DCB in real-world participants with femoropopliteal artery disease. The present analysis included 114 Asian participants (138 lesions) treated in South Korea and Singapore. Assessments through 5 years included freedom from clinically driven target lesion revascularization, the safety endpoint (a composite of freedom from device- and procedure-related mortality through 30 days; and freedom from major target limb amputation and clinically driven target vessel revascularization within 60 months after the index procedure) and major adverse events.<br /><b>Results</b><br />In this prespecified Asian subset, there was a high incidence of diabetes mellitus (54.4%), hypertension (78.1%), coronary artery disease (43.9%), and concomitant below-the-knee vascular disease of target leg (39.5%). Mean lesion length was 17.4 ± 12.4 cm; 26.8% were in-stent restenosis, and more than half of the lesions were totally occluded (51.4%) and calcified (54.3%). The 5-year Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization was 77.1% (95% confidence interval: 67.0%-84.5%). The safety composite endpoint was 76.0%; the cumulative incidence of all-cause mortality was 19.9%, and no major target limb amputations were reported through 5 years.<br /><b>Conclusions</b><br />This subset analysis of Asian participants from the IN.PACT Global Study demonstrated consistent results with the previously reported data of the IN.PACT Admiral DCB. The data confirm the durable clinical effectiveness and safety profile of the DCB through 5 years for femoropopliteal atherosclerotic disease in this real-world population.<br /><br />© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 16 Nov 2022; epub ahead of print</small></div>
Ko YG, Choi D, Rha SW, Won JH, ... Menk JS, Kum S
Catheter Cardiovasc Interv: 16 Nov 2022; epub ahead of print | PMID: 36385562
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<div><h4>Bail out lithotripsy to treat delayed valve-in-valve TAVR-related coronary obstruction.</h4><i>Bingen BO, Al Amri I, Montero-Cabezas JM, van der Kley F</i><br /><AbstractText>Coronary access difficulty and stent compression by the juxtaposed aortic valve leaflet hamper percutaneous management of delayed coronary artery obstruction (CAO) after valve-in-valve (Edwards Sapien 3 in St. Jude Trifecta) transcatheter aortic valve replacement (TAVR). Here, we present a case of delayed post-TAVR CAO treated with intravascular lithotripsy and multistenting to overcome stent compression by the adjacent calcified leaflet.</AbstractText><br /><br />© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 16 Nov 2022; epub ahead of print</small></div>
Bingen BO, Al Amri I, Montero-Cabezas JM, van der Kley F
Catheter Cardiovasc Interv: 16 Nov 2022; epub ahead of print | PMID: 36385465
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<div><h4>SCAI stage reclassification at 24 h predicts outcome of cardiogenic shock: Insights from the Altshock-2 registry.</h4><i>Morici N, Frea S, Bertaina M, Sacco A, ... Tavazzi G, Pappalardo F</i><br /><b>Background</b><br />Cardiogenic shock (CS) includes several phenotypes with heterogenous hemodynamic features. Timely prognostication is warranted to identify patients requiring treatment escalation. We explored the association of the updated Society for Cardiovascular Angiography and Interventions (SCAI) stages classification with in-hospital mortality using a prospective national registry.<br /><b>Methods</b><br />Between March 2020 and February 2022 the Altshock-2 Registry has included 237 patients with CS of all etiologies at 11 Italian Centers. Patients were classified according to their admission SCAI stage (assigned prospectively and independently updated according to the recently released version). In-hospital mortality was evaluated for association with both admission and 24-h SCAI stages.<br /><b>Results</b><br />The overall in-hospital mortality was 38%. Of the 237 patients included and staged according to the updated SCAI classification, 20 (8%) had SCAI shock stage B, 131 (55%) SCAI stage C, 61 (26%) SCAI stage D and 25 (11%) SCAI stage E. In-hospital mortality stratified according to the SCAI classification at 24 h was 18% for patients in SCAI stage B, 27% for SCAI stage C, 63% for SCAI stage D and 100% for SCAI stage E. Both the revised SCAI stages on admission and at 24 h were associated with in-hospital mortality, but the classification potential slightly increased at 24-h. After adjusting for age, sex, lactate level, eGFR, CVP, inotropic score and mechanical circulatory support [MCS], SCAI classification at 24 h was an independent predictor of in-hospital mortality.<br /><b>Conclusions</b><br />In the Altshock-2 registry the utility of SCAI shock stages to identify risk of in-hospital mortality increased at 24 h after admission. Escalation of treatment (either pharmacological or with MCS) should be tailored to achieve prompt clinical improvement within the first 24 h after admission. Registration: http://www.<br /><b>Clinicaltrials</b><br />gov; Unique identifier: NCT04295252.<br /><br />© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print</small></div>
Morici N, Frea S, Bertaina M, Sacco A, ... Tavazzi G, Pappalardo F
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378673
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<div><h4>Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30-day results.</h4><i>Baldus S, Schofer N, Hausleiter J, Friedrichs K, ... Ren CB, Geisler T</i><br /><b>Background</b><br />Severe tricuspid regurgitation (TR) is independently associated with increased morbidity and mortality. Percutaneous transcatheter approaches may offer an alternative for patients not amenable to surgery.<br /><b>Methods</b><br />TriCLASP is a prospective, single-arm, multicenter European post-market clinical follow-up study (NCT04614402) to evaluate the safety and performance of the PASCAL system (Edwards Lifesciences) in patients with severe or greater TR. At 30 days, a composite of major adverse events (MAEs) adjudicated by a clinical events committee, echocardiographic parameters adjudicated by core laboratory, and clinical, functional, and quality-of-life measures were evaluated.<br /><b>Results</b><br />Mean age of the 74 enrolled patients was 80.3 years, with 58.1% female, 90.5% systemic hypertension, and 77.0% in New York Heart Association (NYHA) class III/IV. Mean Society for Thoracic Surgeons score (MV repair) was 9.0%. TR severity was significantly reduced at discharge (p < 0.001) and sustained at 30 days (p < 0.001), and 90.0% of patients achieved ≤moderate TR. The composite MAE rate at 30 days was 3.0%, including 4 events in 2 patients: cardiovascular mortality 1.5%, stroke 1.5%, renal complications requiring unplanned dialysis or renal replacement therapy 1.5%, and severe bleeding 1.5%. There were no nonelective tricuspid valve reinterventions, major access site and vascular complications, major cardiac structural complications, or device embolizations. NYHA class I/II was achieved in 55.8%, 6-minute walk distance improved by 38.2 m (p < 0.001), and Kansas City cardiomyopathy questionnaire scores improved by 13.4 points (p < 0.001).<br /><b>Conclusion</b><br />Experience with the PASCAL transcatheter valve repair system in a European post-market setting confirms favorable safety and effectiveness at 30 days. TR significantly reduced, and clinical, functional, and quality-of-life outcomes significantly improved. This study is ongoing. Clinical Trial Registration: The study is ongoing and registered on ClinicalTrials.gov as NCT04614402. The current analysis is an interim report.<br /><br />© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print</small></div>
Baldus S, Schofer N, Hausleiter J, Friedrichs K, ... Ren CB, Geisler T
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378678
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<div><h4>Chronic total occlusion percutaneous coronary intervention in heart transplant patients.</h4><i>Azzalini L, Moroni F, Dawson KL, Kearney KE</i><br /><AbstractText>Cardiac allograft vasculopathy (CAV) is frequently observed after heart transplant (HT), and represents one of the main causes of chronic rejection, graft loss, and death. While the role of percutaneous coronary intervention (PCI) is well established in the management of CAV in cases of nonocclusive stenoses, the outcomes and technical aspects of this procedure in chronic total occlusions (CTOs) are unknown. We describe our experience with three cases in which CTO PCI was indicated to treat CAV in HT recipients, and we discuss the peculiarities and therapeutic approach to this challenging patient population. In particular, all patients were asymptomatic for angina, and CTO PCI was indicated to promote recovery of left ventricular function, extend graft survival, and/or protect from future ischemic events. CTO PCI was performed using hybrid techniques and was successful in all three cases. Intravascular imaging was used in all cases to maximize the durability of the procedure.</AbstractText><br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print</small></div>
Azzalini L, Moroni F, Dawson KL, Kearney KE
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378679
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<div><h4>Comparison of outcomes in patients with or without ARC-HBR criteria undergoing PCI with polymer-free biolimus coated stents: The BioFreedom France study.</h4><i>Garot P, Brunel P, Dibie A, Morelle JF, ... Lipiecki J, BioFreedom France Investigators</i><br /><b>Background</b><br />The polymer-free biolimus coated stent (BioFreedom) was shown to be superior to bare metal stents in the LEADERS FREE randomized trial in high bleeding risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT). However, there is limited outcome data with this device in an all-comers\' population.<br /><b>Methods</b><br />We conducted a prospective single-arm study of patients undergoing percutaneous coronary intervention with the polymer-free biolimus coated stent in 25 centers in France with wide inclusion criteria including multivessel disease, complex lesions, and acute coronary syndromes. The primary endpoint was the incidence of target lesion failure (TLF), a composite of cardiac death or target-vessel myocardial infarction (MI) or clinically indicated target lesion revascularization (ci-TLR) at 1-year. The patient population was classified according to the presence (or not) of HBR criteria according to the recent ARC-HBR definition.<br /><b>Results</b><br />Between April 2019 and April 2020, 1497 patients were enrolled. TLF occurred in 101 (6.9%) patients, including cardiac death in 35 (2.4%), target vessel MI in 20 (1.4%) and ci-TLR in 65 (4.5%) of them. There were 491 HBR patients (32.8%) and 1006 non-HBR patients. The median duration of DAPT was 74 days in the HBR group versus 348 days in the non-HBR group (p < 0.0001). TLF occurred in 44 (9.2%) of the HBR group and in 57 (5.8%) of the non-HBR group (relative risk 1.62 [95% confidence interval: 1.10-2.41], p = 0015). Compared to the non-HBR group, HBR patients had higher rates of cardiac death (4.4% vs. 1.4%, p = 0.0005) and target vessel MI (2.9% vs. 0.6%, p = 0.0003), but similar rates of ci-TLR. BARC 3-5 bleeding occurred in 6.2% of the HBR group versus 1.4% of the non-HBR group (p < 0.0001).<br /><b>Conclusion</b><br />In this multicenter all-comers study, HBR patients treated with a polymer-free biolimus coated stent had, compared to non-HBR patients, an increased risk of cardiac death and MI, and despite a shorter duration of DAPT, continued to have higher rates of BARC 3-5 bleeding.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print</small></div>
Garot P, Brunel P, Dibie A, Morelle JF, ... Lipiecki J, BioFreedom France Investigators
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378683
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<div><h4>Underweight and obesity are related to higher mortality in patients undergoing coronary angiography: The KARDIO invasive cardiology register study.</h4><i>Laukkanen JA, Kunutsor SK, Hernesniemi J, Immonen J, ... Nikus K, KARDIO Study Group</i><br /><b>Background</b><br />In patients with some cardiovascular disease conditions, slightly elevated body mass index (BMI) is associated with a lower mortality risk (termed \"obesity paradox\"). It is uncertain, however, if this obesity paradox exists in patients who have had invasive cardiology procedures. We evaluated the association between BMI and mortality in patients who underwent coronary angiography.<br /><b>Methods</b><br />We utilised the KARDIO registry, which comprised data on demographics, prevalent diseases, risk factors, coronary angiographies, and interventions on 42,636 patients. BMI was categorised based on WHO cut-offs or transformed using P-splines. Hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated for all-cause mortality.<br /><b>Results</b><br />During a median follow-up of 4.9 years, 4688 all-cause deaths occurred. BMI was nonlinearly associated with mortality risk: compared to normal weight category (18.5-25 kg/m<sup>2</sup> ), the age-adjusted HRs (95% CIs) for all-cause mortality were 1.90 (1.49, 2.43), 0.96 (0.92, 1.01), 1.04 (0.99, 1.09), 1.08 (0.96, 1.20), and 1.45 (1.22, 1.72) for underweight (<18.5 kg/m<sup>2</sup> ), preobesity (25 to <30 kg/m<sup>2</sup> ), obesity class I (30 to <35 kg/m<sup>2</sup> ), obesity class II (35 to <40 kg/m<sup>2</sup> ), and obesity class III (>40 kg/m<sup>2</sup> ), respectively. The corresponding multivariable adjusted HRs (95% CIs) were 2.00 (1.55, 2.58), 0.92 (0.88, 0.97) 1.01 (0.95, 1.06), 1.10 (0.98, 1.23), and 1.49 (1.26, 1,78), respectively.<br /><b>Conclusions</b><br />In patients undergoing coronary angiography, underweight and obesity class III are associated with increased mortality risk, and the lowest mortality was observed in the preobesity class. It appears the obesity paradox may be present in patients who undergo invasive coronary procedures.<br /><br />© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print</small></div>
Laukkanen JA, Kunutsor SK, Hernesniemi J, Immonen J, ... Nikus K, KARDIO Study Group
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378689
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<div><h4>Impact of acute coronary syndrome on clinical outcomes after revascularization with the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent and the sirolimus-eluting Orsiro stent.</h4><i>Jakobsen L, Christiansen EH, Freeman P, Kahlert J, ... Hansen HS, Jensen LO</i><br /><b>Objectives</b><br />To compare the efficacy and safety of the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent (DTS) and the sirolimus-eluting Orsiro stent (O-SES) in patients with and without acute coronary syndrome (ACS) included in the SORT OUT X study.<br /><b>Background</b><br />The incidence of target lesion failure (TLF) after treatment with modern drug-eluting stents has been reported to be significantly higher in patients with ACS when compared to patients without ACS. Whether the results from the SORT OUT X study apply to patients with and without ACS remains unknown.<br /><b>Methods</b><br />In total, 3146 patients were randomized to stent implantation with DTS (n = 1578; ACS: n = 856) or O-SES (n = 1568; ACS: n = 854). The primary end point, TLF, was a composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 1 year.<br /><b>Results</b><br />At 1 year, the rate of TLF was higher in the DTS group compared to the O-SES group, both among patients with ACS (6.7% vs. 4.1%; incidence rate ratio: 1.65 [95% confidence interval, CI: 1.08-2.52]) and without ACS (6.0% vs. 3.2%; incidence rate ratio: 1.88 [95% CI: 1.13-3.14]). The differences were mainly explained by higher rates of TLR, whereas rates of cardiac death and target lesion MI did not differ significantly between the two stent groups in patients with or without ACS <br /><b>Conclusion:</b><br/>Compared to the O-SES, the DTS was associated with a higher risk of TLF at 12 months in patients with and without ACS. The differences were mainly explained by higher rates of TLR.<br /><br />© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print</small></div>
Jakobsen L, Christiansen EH, Freeman P, Kahlert J, ... Hansen HS, Jensen LO
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378691
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<div><h4>Risk factors for percutaneous left ventricular assist device explant complications.</h4><i>Schott JP, Rusia A, Lynch S, Tawney A, ... Balla AK, Hanson ID</i><br /><b>Introduction</b><br />Percutaneous left ventricular assist device (pLVAD) explant remains nonstandardized with potential complications of bleeding and thrombosis. Explant settings include percutaneous techniques in the catheterization laboratory (CL), manually at bedside (MB), and surgically in the operating room (OR).<br /><b>Objective</b><br />Identify high-risk features for explant-related complications, including indication for support, setting, and technique.<br /><b>Methods</b><br />Postexplant bleeding and thrombosis/limb ischemia were identified following pLVAD removals over 2 years at a multicenter healthcare system.<br /><b>Results</b><br />Of 156 patients, bleeding (n = 26 [17%]) and thrombosis (n = 9 [6%]) occurred more often in patients with the peripheral arterial disease (PAD), female gender, anemia, and cardiogenic shock. OR explants had a higher combined endpoint (4/8 [50%]) versus CL (23/133 [17%], p < 0.05) driven by transfusion. There was no difference between OR versus MB (5/15 [33%], p = 0.66) or CL versus MB (p = 0.62). In shock patients, there was no difference between CL (7/30 [23%]) versus MB (5/15 [33%], p = 0.5) and OR (4/7 [57%], p = 0.16); or MB versus OR (p = 0.38). Average length of stay was significantly lower in the CL group versus MB and OR (3.6 ± 33.2 vs. 18.4 ± 10.9 vs. 28.1 ± 15.8 days, p < 0.0001). Preclosure in shock patients (5/25 [20%] vs. 11/27 [41%], p = 0.1383) and crossover balloon occlusion technique (9/44 [16%] vs. 25/112 [22%]; p = 1) were not associated with higher combined endpoints versus control.<br /><b>Conclusion</b><br />Risk factors for pLVAD explant complications include PAD, female gender, and cardiogenic shock. There was no difference in complication rates between explant settings among cardiogenic shock patients, but shorter length of stay when performed in the CL. There was no difference in complication rates when using the crossover balloon occlusion technique.<br /><br />© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print</small></div>
Schott JP, Rusia A, Lynch S, Tawney A, ... Balla AK, Hanson ID
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378715
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<div><h4>Trans-caval aspiration artherectomy/thrombectomy of large mobile plaques and thrombi in aortic arch and descending aorta.</h4><i>Chiang M, Villablanca PA, O\'Neill WW, Frisoli T</i><br /><AbstractText>Aspiration thrombectomy with the AngioVac is approved for percutaneous removal of thrombus in the venous system. While not approved for aspiration of thrombus or other mass in the left heart or arterial system, it has been used in that setting. Patients with left heart or arterial mass are often deemed unfavorable for surgery and treated conservatively. This may not be the best option for all patients, as some may have lesions that represent a short-term increased risk of complications, for which intervention and aspiration could be considered reasonable. Unfortunately, femoral arteries sizes often cannot accommodate the Angiovac current aspiration cannula dimensions. Here, we demonstrated trans-caval approach for aspiration thrombectomy of extensive aortic mobile plaque and thrombus.</AbstractText><br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print</small></div>
Chiang M, Villablanca PA, O'Neill WW, Frisoli T
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378598
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Abstract
<div><h4>Unrecoverable stent deformation in the left main: Crush it or remove it?</h4><i>Achim A, Krivoshei L, Leibundgut G</i><br /><AbstractText>Serial ostial and distal left main lesions continue to be one of the most difficult tasks for the interventional cardiologist, with many potential complications occurring. We present such a high-risk percutaneous coronary intervention where immediate stent explantation was deemed necessary because the metal deformation and high radial strength of the particular stent platform would prevent an acceptable procedural result if it had been crushed to the vessel wall. The aim of this paper was to discuss left main stent deformation, debate the risks and benefits of stent explantation and finally test in-vitro our theory on \"insufficient\" crush with stents with high radial strength and compare it with conventional stents. Bench-testing supports our ad-hoc explantation decision showing stent underexpansion, recoil, and malapposition, obtaining an inadequate minimal stent area.</AbstractText><br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print</small></div>
Achim A, Krivoshei L, Leibundgut G
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378603
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Abstract
<div><h4>Clinical and echocardiographic outcomes with new-onset left bundle branch block after SAPIEN-3 transcatheter aortic valve replacement.</h4><i>Sammour YM, Lak H, Chahine J, Abushouk A, ... Krishnaswamy A, Kapadia SR</i><br /><b>Background</b><br />New-onset left bundle branch block (LBBB) can develop after transcatheter aortic valve replacement (TAVR) resulting in worse outcomes.<br /><b>Aims</b><br />Describe clinical and echocardiographic outcomes with new-onset LBBB after TAVR.<br /><b>Methods</b><br />We included consecutive patients who underwent transfemoral-TAVR with SAPIEN-3 (S3) valve between April 2015 and December 2018. Exclusion criteria included pre-existing LBBB, right BBB, left anterior hemiblock, left posterior hemiblock, wide QRS ≥ 120ms, prior permanent pacemaker (PPM), and nontransfemoral access.<br /><b>Results</b><br />Among 612 patients, 11.4% developed new-onset LBBB upon discharge. The length of stay was longer with new-onset LBBB compared with no LBBB [3 (2-5) days versus 2 (1-3) days; p < 0.001]. New-onset LBBB was associated with higher rates of 30-day PPM requirement (18.6% vs. 5.4%; p < 0.001) and 1-year heart failure hospitalizations (10.7% vs. 4.4%; p = 0.033). There was no difference in 3-year mortality between both groups (30.9% vs. 30.6%; p = 0.829). Further, new-onset LBBB was associated with lower left ventricular ejection fraction (LVEF) at both 30 days (55.9 ± 11.4% vs. 59.3 ± 9%; p = 0.026) and 1 year (55 ± 12% vs. 60.1 ± 8.9%; p = 0.002). These changes were still present when we stratified patients according to baseline LVEF (≥50% or <50%). New-onset LBBBs were associated with a higher 1-year LV end-diastolic volume index (51.4 ± 18.6 vs. 46.4 ± 15.1 ml/m<sup>2</sup> ; p = 0.036), and LV end-systolic volume index (23.2 ± 14.1 vs. 18.9 ± 9.7 ml/m<sup>2</sup> ; p = 0.009). Compared with resolved new-onset LBBB, persistent new-onset LBBB was associated with worse LVEF and higher PPM at 1 year.<br /><b>Conclusions</b><br />New-onset LBBB after S3 TAVR was associated with higher PPM requirement, worse LVEF, higher LV volumes, and increased heart failure hospitalizations, with no difference in mortality.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print</small></div>
Sammour YM, Lak H, Chahine J, Abushouk A, ... Krishnaswamy A, Kapadia SR
Catheter Cardiovasc Interv: 15 Nov 2022; epub ahead of print | PMID: 36378620
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<div><h4>Hybrid coronary revascularization (HCR) versus coronary artery bypass grafting (CABG) in multivessel coronary artery disease (MVCAD): A meta-analysis of 14 studies comprising 4226 patients.</h4><i>Nagraj S, Tzoumas A, Kakargias F, Giannopoulos S, ... Alvarez Villela M, Latib A</i><br /><b>Objectives</b><br />To compare the outcomes of hybrid coronary revascularization (HCR) with traditional coronary artery bypass grafting (CABG) in multivessel coronary artery disease (MVCAD).<br /><b>Background</b><br />HCR has emerged as an alternative to CABG in patients with MVCAD. Through minimally invasive surgical techniques, HCR carries the potential for faster recovery postoperatively, fewer complications, and lower utilization of resources.<br /><b>Methods</b><br />Systematic search of electronic databases was conducted up to December 2021 and studies comparing HCR with CABG in the treatment of MVCAD were included in this meta-analysis. Primary outcomes of interest were incidence of 5-year mortality and major adverse cardiac and cerebral event (MACCE).<br /><b>Results</b><br />Fourteen studies (12 observational studies and 2 randomized controlled trials) comprising 4226 patients were included. The rates of 5-year mortality (odds ratios [OR]: 1.55; 95% confidence interval [CI]: 0.92-2.62; I<sup>2</sup>  = 83.0%) and long-term MACCE (OR: 0.97; 95% CI: 0.47-2.01; I<sup>2</sup>  = 74.7%) were comparable between HCR and CABG groups. HCR was associated with a significantly lower likelihood of perioperative blood transfusion (OR: 0.36; 95% CI: 0.25-0.51; I<sup>2</sup>  = 55.9%), shorter mean hospital stay (weighted mean difference: -2.04; 95% CI: -2.60 to -1.47; I<sup>2</sup>  = 54%), and risk of postoperative acute kidney injury (OR: 0.45; 95% CI: 0.23-0.88; p = 0.02). CABG demonstrated a lower likelihood of requiring long-term repeat revascularization (OR: 1.51; 95% CI: 1.03-2.20; I<sup>2</sup>  = 18%) over a follow-up duration of 29.14 ± 21.75 months.<br /><b>Conclusion</b><br />This meta-analysis suggests that HCR is feasible and safe for the treatment of MVCAD. However, benefits of HCR should be carefully weighed against the increased long-term risk of repeat-revascularization when selecting patients, and further studies evaluating differences in long-term mortality between HCR and CABG are required.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 06 Nov 2022; epub ahead of print</small></div>
Nagraj S, Tzoumas A, Kakargias F, Giannopoulos S, ... Alvarez Villela M, Latib A
Catheter Cardiovasc Interv: 06 Nov 2022; epub ahead of print | PMID: 36335643
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<div><h4>Three versus 12-month dual antiplatelet therapy duration in patients with acute coronary syndrome undergoing percutaneous coronary intervention: A meta-analysis of randomized controlled trials.</h4><i>Selvaraj V, Chatterjee S, Hirai T, Abbott JD, Bavishi C</i><br /><b>Introduction</b><br />The American Heart Association/American College of Cardiology guidelines on dual antiplatelet therapy (DAPT) recommend at least 12 months of a P2Y12 inhibitor and low dose aspirin in patients with an acute coronary syndrome (ACS) treated with a stent. Since that recommendation, several randomized controlled trials (RCTs) have studied an abbreviated duration of DAPT in ACS. Therefore, we sought to perform a meta-analysis of RCTs comparing 3- versus 12-month DAPT in patients presenting with ACS undergoing percutaneous coronary intervention (PCI).<br /><b>Methods</b><br />PubMed, Embase, and Cochrane Central databases were searched until July 31, 2022, for RCTs comparing 3- versus 12-month DAPT in patients with ACS undergoing PCI. Outcomes assessed were major adverse cardiovascular events (MACE), cardiovascular mortality, all-cause mortality, myocardial infarction (MI), stent thrombosis (ST) and bleeding. A random-effects model was used to calculate pooled relative risk (RR) and 95% confidence intervals (CI).<br /><b>Results</b><br />We included 5 trials comprising 16,781 patients with an ACS that underwent PCI. There was no significant difference in MACE (RR: 0.92; 95% CI: 0.76-1.11), cardiovascular mortality (RR: 1.26; 95% CI: 0.38-4.17), or all-cause mortality (RR: 0.92; 95% CI: 0.48-1.77) between the 2 groups. In addition, there was no difference in rates of MI (RR: 0.98; 95% CI: 0.74-1.30), or ST (RR: 1.30; 95% CI: 0.55-3.05) between 3- and 12-month DAPT. However, compared with 12-month DAPT, 3-month DAPT significantly reduced risk of major bleeding (RR: 0.53; 95% CI: 0.43-0.64).<br /><b>Conclusions</b><br />In patients with ACS undergoing PCI, 3-month DAPT reduced risk of bleeding without evidence of harm.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 03 Nov 2022; epub ahead of print</small></div>
Selvaraj V, Chatterjee S, Hirai T, Abbott JD, Bavishi C
Catheter Cardiovasc Interv: 03 Nov 2022; epub ahead of print | PMID: 36326115
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<div><h4>Stent expansion of restrictive Fontan conduits to nominal diameter and beyond.</h4><i>Salaets T, Cools B, De Meester P, Heying R, ... Budts W, Gewillig M</i><br /><b>Background</b><br />Mechanical factors may cause bottlenecks in a Fontan circuit. Extracardiac conduits (ECC) are placed at a young age, but the materials do not allow growth. Restriction in ECC dimensions may deteriorate the function of the circuit.<br /><b>Aims</b><br />This study aimed to evaluate the feasibility and safety of stent expansion of an ECC to the nominal dimension at the time of implant and, if possible, beyond nominal.<br /><b>Methods</b><br />Retrospective, single-center observational review of all ECC Fontan patients who received a stent to expand a previously placed surgical conduit.<br /><b>Results</b><br />A total of 44 restrictive conduits were stented over a 14-year study period with a median of 11.8 (interquartile ranges [IQR]: 9.1-13.8) years after ECC placement. Cross-sectional areas were a median of 30% (IQR: 21-42) smaller than the originally placed ECC; there was no gradient in 23/44 patients and in 21/44, a minimal gradient of 1.3 ± 0.5 (range 1-3 mmHg). All conduits could be enlarged with a significant (p < 0.0001) increase in diameter from 13.6 ± 1.8 to 19.2 ± 1.2 mm, corresponding to a median cross-sectional area increase of 171% (IQR: 153-220). In three patients where the conduits were not contracted, expansion of between 127% and 165% was obtained. There were no conduit ruptures and only one minor complication.<br /><b>Conclusions</b><br />ECC in some Fontan patients become smaller than nominal over time, usually without overt symptoms. The dimensions of ECC\'s can be safely and significantly increased to nominal or even beyond employing stenting. It allows adjustment of ECC dimensions to compensate for somatic growth.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print</small></div>
Salaets T, Cools B, De Meester P, Heying R, ... Budts W, Gewillig M
Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print | PMID: 36321584
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Abstract
<div><h4>Right atrial structural remodeling predict worse outcomes in transcatheter mitral valve repair.</h4><i>Miller MS, Cutts J, Donatelle M, Shah K, ... Bilchick K, Mazimba S</i><br /><b>Background</b><br />In the current study, we assess the predictive role of right and left atrial volume indices (RAVI and LAVI) as well as the ratio of RAVI/LAVI (RLR) on mortality following transcatheter mitral valve repair (TMVr).<br /><b>Methods</b><br />Transthoracic echocardiograms of 158 patients who underwent TMVr at a single academic medical center from 2011 to 2018 were reviewed retrospectively. RAVI and LAVI were calculated using Simpson\'s method. Patients were stratified based on etiology of mitral regurgitation (MR). Cox proportional-hazard regression was created utilizing MR type, STS-score, and RLR to assess the independent association of RLR with survival. Kaplan-Meier analysis was used to analyze the association between RAVI and LAVI with all-cause mortality. Hemodynamic values from preprocedural right heart catheterization were also compared between RLR groups.<br /><b>Results</b><br />Among 123 patients included (median age 81.3 years; 52.5% female) there were 50 deaths during median follow-up of 3.0 years. Patients with a high RAVI and low LAVI had significantly higher all-cause mortality while patients with high LAVI and low RAVI had significantly improved all-cause mortality compared to other groups (p = 0.0032). RLR was significantly associated with mortality in patients with both functional and degenerative MR (p = 0.0038). Finally, Cox proportion-hazard modeling demonstrated that an elevated RLR above the median value was an independent predictor of all-cause mortality [HR = 2.304; 95% CI = 1.26-4.21, p = 0.006] when MR type and STS score were accounted for.<br /><b>Conclusion</b><br />Patients with a high RAVI and low LAVI had significantly increased mortality than other groups following TMVr suggesting RA remodeling may predict worse outcomes following the procedure. Concordantly, RLR was predictive of mortality independent of MR type and preprocedural STS-score. These indices may provide additional risk stratification in patients undergoing evaluation for TMVr.<br /><br />© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print</small></div>
Miller MS, Cutts J, Donatelle M, Shah K, ... Bilchick K, Mazimba S
Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print | PMID: 36321593
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<div><h4>Prediction of functional results of percutaneous coronary interventions with virtual stenting and quantitative flow ratio.</h4><i>Lee HJ, Mejía-Rentería H, Escaned J, Doh JH, ... Shin ES, Koo BK</i><br /><b>Background</b><br />The clinical value of residual quantitative flow ratio (rQFR), a novel function of QFR technique, is unknown.<br /><b>Aim</b><br />We investigated the clinical value of rQFR, aimed to predict residual ischemia after virtual percutaneous coronary intervention (vPCI).<br /><b>Methods</b><br />This is a substudy of the COE-PERSPECTIVE registry, which investigated the prognostic value of post-PCI fractional flow reserve (FFR). From pre-PCI angiograms, QFR and rQFR were analyzed and their diagnostic performance was assessed at blinded fashion using pre-PCI FFR and post-PCI FFR as reference, respectively. The prognostic value of rQFR after vPCI was assessed according to vessel-oriented composite outcome (VOCO) at 2 years.<br /><b>Results</b><br />We analyzed 274 patients (274 vessels) with FFR-based ischemic causing lesions (49%) from 555 screened patients. Pre-PCI QFR and FFR were 0.63 ± 0.10 and 0.66 ± 0.11 (R = 0.756, p < 0.001). rQFR after vPCI and FFR after real PCI were 0.93 ± 0.06 and 0.86 ± 0.07 (R = 0.528, p < 0.001). The mean difference between rQFR and post-PCI FFR was 0.068 (95% limit of agreement: -0.05 to 0.19). Diagnostic performance of rQFR to predict residual ischemia after PCI was good (area under the curve [AUC]: 0.856 [0.804-0.909], p < 0.001). rQFR predicted well the incidence of 2-year VOCO after index PCI (AUC: 0.712 [0.555-0.869], p = 0.041), being similar to that of actual post-PCI FFR (AUC: 0.691 [0.512-0.870], p = 0.061). rQFR ≤0.89 was associated with increased risk of 2-year VOCO (hazard ratio [HR]: 12.9 [2.32-71.3], p = 0.0035). This difference was mainly driven by a higher rate of target vessel revascularization (HR: 16.98 [2.33-123.29], p = 0.0051).<br /><b>Conclusions</b><br />rQFR estimated from pre-PCI angiography and virtual coronary stenting mildly overestimated functional benefit of PCI. However, it well predicted suboptimal functional result and long-term vessel-related clinical events.<br /><b>Clinical trial registration</b><br />Influence of fractional flow reserve on the Clinical OutcomEs of PERcutaneouS Coronary Intervention (COE-PESPECTIVE) Registry, NCT01873560.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print</small></div>
Lee HJ, Mejía-Rentería H, Escaned J, Doh JH, ... Shin ES, Koo BK
Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print | PMID: 36321601
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<div><h4>Diagnostic accuracy of angiography-based vessel fractional flow reserve after chronic coronary total occlusion recanalization.</h4><i>Scoccia A, Scarparo P, Neleman T, Kakar H, ... Daemen J, Diletti R</i><br /><b>Background</b><br />Angiography-based vessel fractional flow reserve (vFFR) demonstrated a strong correlation with invasive fractional flow reserve (FFR) in both a pre- and post-percutaneous coronary intervention (PCI) setting. However, the role of vFFR and its correlation with post-PCI FFR in chronic coronary occlusions (CTO) has not been evaluated yet. We sought to investigate the diagnostic performance of post-PCI vFFR with post-PCI FFR as a reference in patients undergoing successful CTO PCI.<br /><b>Methods</b><br />Between March 2016 and April 2020, a total of 80 patients from the FFR-SEARCH (prospective registry) and FFR REACT (randomized controlled trial) studies underwent successful CTO recanalization with post-PCI FFR measurements.<br /><b>Results</b><br />A total of 50 patients (median age 66 (interquartile range [IQR]: 56-74) years, 76% were male) were eligible for the analysis. Median post-PCI FFR was 0.89 (IQR: 0.84-0.94), while median post-PCI vFFR was 0.91 (IQR: 0.85-0.94) (p 0.10). Suboptimal physiological results, defined as FFR and vFFR <0.90, were identified in 26 (52%) and in 21 (42%) patients, respectively. A strong correlation (r = 0.82) was found between vFFR and FFR with a mean bias of 0.013 ± 0.051. Receiver-operating characteristics curve analysis revealed an excellent accuracy of vFFR in predicting FFR <0.90 (area under the curve: 0.97; 95% confidence interval: 0.93-1.00).<br /><b>Conclusion</b><br />Post-PCI vFFR shows a good correlation with post-PCI FFR and a high diagnostic accuracy for post-PCI FFR ≤0.90 in patients undergoing successful PCI of a CTO lesion.<br /><br />© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print</small></div>
Scoccia A, Scarparo P, Neleman T, Kakar H, ... Daemen J, Diletti R
Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print | PMID: 36321612
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<div><h4>Feasibility of transcaval access TAVI in morbidly obese patients: A single-center experience.</h4><i>Michail M, Cockburn J, Tanseco KVP, Arunothayaraj S, ... Trivedi U, Hildick-Smith D</i><br /><b>Objectives</b><br />We report a single-center experience in utilizing the transcaval-access transcatheter aortic valve implantation (TAVI) as an alternative approach in morbidly obese patients.<br /><b>Background</b><br />Morbidly obese patients present frequently for TAVI. Transfemoral arterial access TAVI in these patients is technically challenging due to deep arterial access, resulting in a higher risk of vascular complications. Transcaval access TAVI is increasingly used in patients with prohibitive iliofemoral arterial access.<br /><b>Methods</b><br />We used the transcaval approach for eight morbidly obese patients who had otherwise technically feasible femoral arterial access. This technique provides an alternative arterial access point that potentially circumvents some of the challenges relating to femoral arterial access.<br /><b>Results</b><br />We report eight morbidly obese patients with a mean body mass index of 42.3 ± 6.2 kg/m<sup>2</sup> who underwent transcaval access TAVI at our center (mean EuroScore II 2.47 ± 1.83%). The patient mean age was 70.3 ± 9.8 years; six were female. All eight patients underwent a successful and uncomplicated procedure. The median time to discharge was 2 days and all patients were alive at 30 days.<br /><b>Conclusions</b><br />Transcaval access TAVI is a feasible alternative for morbidly obese patients and may reduce vascular complications. Further data are required to evaluate the safety of this approach.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print</small></div>
Michail M, Cockburn J, Tanseco KVP, Arunothayaraj S, ... Trivedi U, Hildick-Smith D
Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print | PMID: 36321613
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<div><h4>A new FDA approved stent for congenital heart disease: First-in-man experiences with G-ARMOR.</h4><i>Morgan GJ, Zablah J</i><br /><AbstractText>We present the first clinical experience with a new hybrid cell structure covered stent, designed for congenital heart disease applications. It represents a significant redesign of the Cheatham Platinum (CP) Stent (Numed Inc.), maintaining the traditional benefits of the covered CP whilst significantly decreasing shortening and allowing controlled flaring at the ends through its combination of larger and standard sized cells. We first implanted the stent in 2 patients with superior sinus venosus defects with anomalous drainage of the right upper and middle lobe pulmonary veins. The first was a 40 year male and the second a 36 year old female. The third case was a 60 year old patient with near atresia of the aorta, with pre and poststenotic aortic dilation. The clinical result in all cases was excellent with no obstruction to pulmonary venous return and no visible L-R shunt on the transthoracic echo on 24 h and 2 week follow-up for the patient with sinus venosus defects and uniform complete revascularization of the aorta without any vascular complications in the patient with coarctation. These are the first uses of this stent in human subjects. The design is specifically aimed toward procedures where stent shortening is undesirable. Hence, coarctation of the aorta as well as stent implantation in preparation for percutaneous pulmonary valve placement are obvious use areas, as well as the growing body of evidence supporting percutaneous treatment of sinus venosus defects.</AbstractText><br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print</small></div>
Morgan GJ, Zablah J
Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print | PMID: 36321626
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<div><h4>Coronary angiography of the ex-situ beating donor heart in a portable organ care system.</h4><i>Meredith T, Scheuer S, Hoffman M, Joshi Y, ... Macdonald P, Muller D</i><br /><b>Objectives</b><br />To determine safety and feasibility of ex-situ coronary angiography.<br /><b>Background</b><br />To cater for the perpetually growing demand for heart donors, interest in donation following circulatory death (DCD) has been rekindled. Further pursuit of donor pool expansion has led to eligibility extension to \"marginal\" donors who are at higher risk of coronary artery disease (CAD). Excluding CAD in potentially eligible DCD donors, for whom ante-mortem angiography is commonly not permitted, is therefore challenging. Ex-situ coronary angiography serves as an ethical and feasible diagnostic tool to assess for preclusive CAD.<br /><b>Methods</b><br />We undertook a systematic review of the published literature and institutional retrospective review of case experience with ex-situ coronary angiography of donor hearts, supported by a portable organ care system.<br /><b>Results</b><br />Combined literature and institutional case review yielded nine total cases of ex-situ coronary angiography of donor human hearts plus one experimental porcine model. Of the eight cases of ex-situ coronary angiography performed at our institute, all were conducted without complication or injury to the allograft. Two thirds of reported human cases have proceeded to successful transplantation.<br /><b>Conclusions</b><br />Diagnostic coronary angiography of the ex-situ beating donor heart is safe, feasible, and demonstrates novel clinical utility in mitigating subsequent transplantation of unsuitable allografts. In the setting of suspected coronary atherosclerosis of the donor heart, which may preclude favorable transplantation outcomes, ex-situ coronary angiography should be considered at eligible transplant centers.<br /><br />© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print</small></div>
Meredith T, Scheuer S, Hoffman M, Joshi Y, ... Macdonald P, Muller D
Catheter Cardiovasc Interv: 02 Nov 2022; epub ahead of print | PMID: 36321629
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<div><h4>Improving efficiency and operator proficiency during percutaneous coronary interventions utilizing a standardized optical coherence tomography workflow.</h4><i>Khuddus MA, Darki A, Padaliya BB, West NEJ, ... Secemsky EA, LightLab Initiative Investigators</i><br /><b>Objectives</b><br />This study was designed to compare efficiency and quality metrics between percutaneous coronary intervention (PCI) procedures using optical coherence tomography (OCT) guided by a variable workflow versus a standardized workflow in a real-world population.<br /><b>Background</b><br />The LightLab (LL) Initiative was designed to evaluate the impact of a standardized OCT workflow during PCI to address barriers to adoption.<br /><b>Methods</b><br />The LL Initiative was a multicenter, prospective, observational study. PCI efficiency data were collected from 1/21/19 to 1/8/21 from 45 physicians at 17 US centers. OCT-guided PCIs were compared between baseline phase (variable workflow; N = 383) and the LL workflow utilization phase (N = 447). The LL workflow uses OCT to assess lesion Morphology, Length and Diameter, and then optimize outcomes by correcting for Medial dissection, stent mal-Apposition, and under-eXpansion (MLD MAX). Matching based on propensity scores was used to control for differences between PCIs.<br /><b>Results</b><br />After propensity matching, 291 paired procedures were included. Integration of the LL versus variable workflow resulted in no difference in procedure time (51 min vs. 51 min, p = 0.93). There was a reduction in radiation exposure (1124 mGy vs. 1493 mGy, p < 0.0001) and contrast volume (160 cc vs. 172 cc, p < 0.001). The LL workflow decreased the proportion of underexpanded lesions (34% vs. 54%, p < 0.0001) and improved minimum stent expansion (85% vs. 79%, p < 0.0001). Number of noncompliant balloons used was reduced with the LL workflow. (2.0 vs. 1.7, p < 0.01).<br /><b>Conclusions</b><br />These data suggest that standardizing imaging with the LL workflow may overcome barriers to imaging and improve PCI outcomes without prolonging procedures.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 01 Nov 2022; 100:S14-S24</small></div>
Khuddus MA, Darki A, Padaliya BB, West NEJ, ... Secemsky EA, LightLab Initiative Investigators
Catheter Cardiovasc Interv: 01 Nov 2022; 100:S14-S24 | PMID: 36661365
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Abstract
<div><h4>OCT utilization: Summary statistics from the LightLab clinical initiative.</h4><i>Raja A, Osborn EA, Bergmark BA, Croce KD, ... Secemsky EA, LightLab Clinical Initiative Investigators</i><br /><b>Objectives</b><br />The study describes the evolution of optical coherence tomography (OCT) adoption and performance during percutaneous coronary intervention (PCI) following implementation of a standardized LightLab (LL) workflow.<br /><b>Background</b><br />The purpose of the LL Clinical Initiative was to evaluate the impact of a standardized workflow on physician efficiency, decision making, and image quality.<br /><b>Methods</b><br />The LL Clinical Initiative is a multicenter, prospective, observational clinical program. Data were collected from 48 physicians at 17 U.S. centers from 01/21/19 to 06/08/21. The study included 401 OCT-guided PCIs during the baseline phase and 1898 during the LL workflow phases. The baseline phase consisted of physicians utilizing OCT at their discretion. After completing the baseline phase, the workflow progressed through multiple phases culminating in the expansion phase, which focused on addressing greater procedural complexity. The LL workflow utilized OCT to assess plaque Morphology, lesion Length, and vessel Diameter before PCI, and optimized results by treating Medial edge dissection, stent mal-Apposition, and stent under-eXpansion (MLD MAX). High-level summary statistics were generated to elucidate trends.<br /><b>Results</b><br />After program implementation, there was a rise in the number of PCIs where the LL workflow was utilized compared to the baseline phase (68% during the expansion phase vs. 41% at baseline; p for trend <0.0001). Adoption of the LL workflow was associated with progressively greater procedural and lesion complexity when OCT was performed pre- and post-PCI (87% vs. 52%, p < 0.0001; 55% vs. 37%, p < 0.0001, respectively). In addition, the quality of OCT imaging obtained improved after LL workflow introduction, with over 95% of pre- and post-PCI pullback quality considered usable during the expansion phase. Finally, there was a reduction in time spent on OCT interpretation, both pre-PCI (4.6 min vs. 7.5 min, p < 0.0001) and post-PCI (2.9 min vs. 5.3 min, p < 0.0001).<br /><b>Conclusions</b><br />After completion of the standardized OCT-guided workflow, there was greater uptake of OCT imaging, incorporation in more complex procedures, procedural efficiency, and image quality.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 01 Nov 2022; 100:S36-S43</small></div>
Raja A, Osborn EA, Bergmark BA, Croce KD, ... Secemsky EA, LightLab Clinical Initiative Investigators
Catheter Cardiovasc Interv: 01 Nov 2022; 100:S36-S43 | PMID: 36661366
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Abstract
<div><h4>The MLD MAX OCT algorithm: An imaging-based workflow for percutaneous coronary intervention.</h4><i>Shlofmitz E, Croce K, Bezerra H, Sheth T, ... Shlofmitz R, Ali ZA</i><br /><AbstractText>Although extensive clinical data support the utility of intravascular imaging to guide and optimize outcomes following percutaneous coronary interventions (PCI), clinical adoption remains limited. One of the primary reasons for limited utilization may be a lack of standardization on how to best integrate the data provided by intravascular imaging practically. Optical coherence tomography (OCT) offers a high-resolution intravascular imaging modality with integrated software automation that allows for incorporation of OCT into the routine workflow of PCIs. We suggest use of an algorithm called MLD MAX to incorporate OCT for imaging-guided interventions: the baseline OCT imaging run is intended to facilitate procedural planning and strategizing, consisting of assessment for predominant lesion morphology (M), measurement for stent length (L) and determination of stent diameter (D); the post-PCI OCT imaging run is designated for assessment of need for further optimization of stent result, and consists of analysis for medial dissections (M), adequate stent apposition (A) and stent expansion (X). Incorporation of the MLD MAX algorithm into daily practice guides an efficient and easily-memorable workflow for optimized PCI procedures.</AbstractText><br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 01 Nov 2022; 100:S7-S13</small></div>
Shlofmitz E, Croce K, Bezerra H, Sheth T, ... Shlofmitz R, Ali ZA
Catheter Cardiovasc Interv: 01 Nov 2022; 100:S7-S13 | PMID: 36661367
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Abstract
<div><h4>Investigating real-world impact of optical coherence tomography workflow-guided coronary interventions: Design and rationale of the LightLab Clinical Initiative.</h4><i>Buccola J, Meinen J, Spinelli J, Hammerstone M, Rapoza R, West NEJ</i><br /><b>Objective</b><br />The LightLab Clinical Initiative was designed to examine adoption of optical coherence tomography (OCT) imaging during routine percutaneous coronary intervention (PCI) practice, and enable identification and reduction of barriers to broader adoption of intracoronary imaging in real-world practice.<br /><b>Background</b><br />Intracoronary imaging guidance during PCI has been shown to improve clinical outcomes and features as a recommendation in societal guidelines, yet widespread routine adoption remains low. Perceived barriers to utilization include familiarity with, and ability to interpret imaging, concerns over added procedure time and contrast load, alongside a lack of actionable outcome data.<br /><b>Methods and results</b><br />LightLab was a multicenter prospective observational data-gathering project, conducted between January 2019, and June 2021, with 17 participating hospitals and physicians. Data were gathered in real-time, where OCT guidance was employed during PCI using a standardized OCT-guided workflow algorithm, MLD MAX (where MLD stands for plaque Morphology, lesion Length, vessel Diameter and MAX for Medial dissection, stent Apposition, stent eXpansion) which was developed to simplify and integrate information from OCT throughout the PCI procedure. Integration of this workflow/algorithm was implemented through a series of phases, focusing on physician decision-making, efficiency, and safety improvements during the procedure.<br /><b>Conclusions</b><br />Through real-time, prospective procedural data acquisition in the cardiac catheterization laboratory setting, the LightLab Clinical Initiative demonstrates the impact of a standardized OCT-guided workflow on procedural metrics, including time, contrast use, radiation exposure, as well as financial efficiencies such as device utilization. These results can potentially mitigate underlying concerns over the utility of adoption of intracoronary imaging guidance during PCI.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 01 Nov 2022; 100:S1-S6</small></div>
Buccola J, Meinen J, Spinelli J, Hammerstone M, Rapoza R, West NEJ
Catheter Cardiovasc Interv: 01 Nov 2022; 100:S1-S6 | PMID: 36661368
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Abstract
<div><h4>Determinants and long-term outcomes of largely uncovered struts in thin-struts drug-eluting stents assessed by optical coherence tomography.</h4><i>Moretti F, Bernelli C, Pellegrini D, Boccuzzi G, ... Capodanno D, Guagliumi G</i><br /><b>Background</b><br />Uncovered struts are a determinant of stent failure. The impact of plaque composition and procedural factors on the occurrence, evolution, and outcomes of uncovered struts in a high-risk setting has not been investigated.<br /><b>Objective</b><br />To investigate the determinants and long-term clinical impact of largely uncovered struts (LUS) in thin-struts drug-eluting stents (DES) implanted in complex lesions by intracoronary optical coherence tomography (OCT).<br /><b>Methods</b><br />Ninety patients with multivessel disease undergoing staged complete revascularization were randomly assigned to bioabsorbable or durable polymer DES. OCT were serially performed during the index procedure, at 3- and 18-month follow-up, and analyzed by an independent core lab. Struts were defined uncovered by OCT if no tissue was visible above the struts. LUS were defined as ≥30% of uncovered struts at 3-month follow-up. Clinical outcomes were the occurrence of target vessel failure (TVF) and major adverse cardiac and cerebrovascular events (MACCE) at 5-year follow-up.<br /><b>Results</b><br />LUS occurred in 31 patients (34.4%) regardless of stent platform. At 5 years, no differences were observed in the rate of TVF (12.7% vs. 13.4%; p = 0.91) and MACCE (23.9% vs. 24.9%; p = 0.88) between the two groups. At multivariate logistic regression, plaque rupture, mean lumen diameter, proximal reference vessel area, and maximum stent deployment pressure were independent predictors of LUS.<br /><b>Conclusions</b><br />LUS are a frequent finding in complex coronary lesions treated with thin-struts DES, especially in the presence of plaque rupture. However, in this study, no significant safety signal related to LUS emerged in long-term follow-up.<br /><br />© 2022 Wiley Periodicals LLC.<br /><br /><small>Catheter Cardiovasc Interv: 01 Nov 2022; 100:S25-S35</small></div>
Moretti F, Bernelli C, Pellegrini D, Boccuzzi G, ... Capodanno D, Guagliumi G
Catheter Cardiovasc Interv: 01 Nov 2022; 100:S25-S35 | PMID: 36661369
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Older ...

This program is still in alpha version.