Overview of in-hospital outcomes in patients undergoing percutaneous coronary intervention with the revived directional coronary atherectomy.

Numasawa Y, Inohara T, Ishii H, Yamaji K, ... Ikari Y, J-PCI Registry Investigators
Objectives
We sought to provide clinical insights on the usage rate, indications, and in-hospital outcomes of the revived directional coronary atherectomy (DCA) catheter (Atherocut™) in a Japanese nationwide percutaneous coronary intervention (PCI) registry.
Background
Debulking devices such as the revived DCA catheter have become increasingly important in the era of complex PCI. However, little is known about PCI outcomes using a novel DCA catheter in contemporary real-world practice.
Methods
We analyzed 188,324 patients who underwent PCI in 1112 hospitals from January to December 2018. Baseline characteristics and in-hospital outcomes of patients with stable coronary artery disease or unstable angina who underwent PCI with or without the DCA were analyzed.
Results
Overall, 1696 patients (0.9%) underwent PCI with the DCA during the study period, predominantly for left main trunk or proximal left anterior descending artery lesions under a transfemoral approach. Patients in the DCA group were younger and had fewer comorbidities such as hypertension, diabetes mellitus, and chronic kidney disease than patients in the non-DCA group. Stentless PCI using the DCA with drug-coated balloon angioplasty was a preferred treatment strategy in the DCA group (50.0%). Predefined in-hospital adverse outcomes, including mortality (0.2% vs. 0.3%, p = 0.446) and periprocedural complications (1.8% vs. 1.7%, p = 0.697), were comparable between the two groups, whereas the fluoroscopy time was longer and the total contrast volume was higher in the DCA group.
Conclusions
In Japan, PCI using the revived DCA catheter is safely performed with low complication rates in patients with stable coronary artery disease or unstable angina.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 20 May 2022; epub ahead of print

Real-world experience with the new Watchman FLX device: Data from two high-volume Sicilian centers. The FLX-iEST registry.

Vizzari G, Grasso C, Sardone A, Mazzone P, ... Tamburino C, Contarini M
Introduction
The Watchman-FLX left atrial appendage closure (LAAC) device presents innovative features: higher conformability, reduced length, closed distal \"flex-ball\" during deployment, and flattened surface. We report our real-world experience with the Watchman-FLX device in two centers with consolidated LAAC expertise.
Methods
We enrolled 200 consecutive Watchman-FLX patients (2019-2021) in a nonrandomized double-center registry; procedural data and follow-up for midterm clinical outcomes were collected. A control group of 100 patients treated with first-generation Watchman (2.5) was included.
Results
According to mean CHAD₂ DS₂ -VASc (5 ± 1.40) and HAS-BLED (3.8 ± 1.01) scores, the population included in this study was at high risk: 29% had a previous stroke and 56.5% a bleeding event. Main LAAC indications were symptomatic hemorrhage (39.5%), need for triple antithrombotic therapy (39%), gastrointestinal bleeding (32%), and oral anticoagulation intolerance (18%). Transesophageal echocardiography guidance was followed in 93% of cases (48% in general anesthesia and 45% under conscious sedation). Repositioning an FLX device was required in 20% of cases and no complication occurred. In 96% of patients, the first selected device was delivered, while in 4% a device size change was required after the first choice (7% with Watchman 2.5). Peridevice leaks (<5 mm) were found postimplant in two cases (1%). Overall, the procedural success rate was 99.5%. One patient\'s procedure was unsuccessful (0.5%), due to left atrial appendage (LAA) anatomy; differently, the mean failure rate with Watchman 2.5 was 2%. No device embolization was reported. Complications (8.5%) were mainly related to the access site (3%); major bleedings (1%), and in-hospital death (0.5%) rarely occurred. After a follow-up of 272 ± 173 days, 2.3% of cases experienced a non-device-related stroke and 0.6% fatal bleeding.
Conclusion
Our registry showed a high procedural success rate of the Watchman-FLX in a high-risk population. According to our experience, the main advantages include easy implanting and repositioning, absence of embolization, good LAA sealing, and low rate of complications in the follow-up period.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 20 May 2022; epub ahead of print

Temporal changes and clinical significance of peridevice leak following left atrial appendage occlusion with Amplatzer devices.

Korsholm K, Jensen JM, Nørgaard BL, Nielsen-Kudsk JE
Background
The natural history of peridevice leak (PDL) following left atrial appendage occlusion (LAAO) is unknown. This study sought to investigate changes of PDL from 2 until 12 months after LAAO, using cardiac computed tomography (CT), and to assess the potential association between persistent PDL and clinical outcomes
Methods:
Single-center observational study of Amplatzer LAAO implants between 2010 and 2017 (n = 206). Patients with 2 and 12 months cardiac CT were included in the study (n = 153). Images were blindly analyzed. PDL was characterized by frequency and size at the device disc, lobe, and left atrial appendage contrast patency. Patients were followed for the composite outcome of ischemic stroke, transient ischemic attack, systemic embolism, or all-cause death. Median follow up from LAAO was 3.1 (2.3-4.3) years.
Results
Contrast patency was present in 101 (66%) and 72 (47%) (p < 0.001) at 2 and 12 months, respectively. PDL was identified at the disc in 103 (67%) patients at 2 months versus 93 (61%) at 12 months (p = 0.08), and at the lobe in 29 (19%) at both time points. PDL area at the disc did not change significantly over time, ∆ $\\unicode{x02206}$ area: -8.95 mm (95% confidence interval [CI]: -18.9; 1.01) p = 0.08. Permanent atrial fibrillation was independently associated with persistent PDL. Persistent versus no PDL was associated with a 62% worse clinical outcome, however not statistically significant, hazard ratio (HR): 1.62 (95% CI: 0.9-2.93), p = 0.11.
Conclusion
Persistent PDL was frequently observed following LAAO with Amplatzer devices. The PDL frequency and size appeared unchanged between 2 and 12 months. Persistent PDL was not significantly associated with worse clinical outcomes, yet this needs further delineation in future studies.

Catheterization and Cardiovascular Interventions© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 18 May 2022; epub ahead of print

Percutaneous approach to left ventricular assist device decommissioning.

Moroni F, Shah KB, Quader MA, Klein K, ... Parris KE, Gertz ZM
Objective
To assess the outcomes of a single-center experience with percutaneous left ventricular assist device (LVAD) decommissioning.
Background
Patients with LVADs may eventually require their removal, either due to recovery of left ventricular function or recurrent complications. Traditionally, withdrawal of LVAD support has been managed with surgical device explantation, which carries significant procedural risks. Transcatheter LVAD decommissioning, with outflow graft occlusion and driveline transection, has recently been described as an alternative to surgical removal.
Methods
Here, we report on a retrospective cohort of five consecutive cases treated with transcatheter LVAD decommissioning.
Results
The procedure was effective in all cases, and no patient experienced procedure-related complications. At midterm follow-up, the three patients who had myocardial function recovery were alive and had not experienced heart failure-related symptoms or complications.
Conclusion
Percutaneous LVAD decommissioning appears to be a safe and effective approach to LVAD treatment discontinuation.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 17 May 2022; epub ahead of print

In-hospital mortality and readmission after ST-elevation myocardial infarction in nonagenarians: A nationwide analysis from the United States.

Ismayl M, Machanahalli Balakrishna A, Walters RW, Pajjuru VS, Goldsweig AM, Aboeata A
Objectives
To assess readmission rates in nonagenarians (age ≥ 90 years) with ST-elevation myocardial infarction (STEMI) following primary percutaneous coronary intervention (pPCI) versus no pPCI.
Background
There are limited data exploring readmissions following STEMI in nonagenarians undergoing pPCI versus no pPCI.
Methods
We retrospectively analyzed the Nationwide Readmissions Database to identify nonagenarians hospitalized with STEMI. We divided the cohort into two groups based on pPCI status. We compared mortality during index hospitalization and during 30-day readmission, readmission rates, and causes of readmissions.
Results
We identified 58,231 nonagenarian STEMI hospitalizations between 2010 and 2018, of which 18,809 (32.3%) included pPCI, and 39,422 (67.7%) had no pPCI. Unadjusted unplanned 30-day readmission was higher in pPCI cohort (21.0% vs. 15.4%, p < 0.001). However, mortality during index hospitalization and during 30-day readmission were significantly lower in pPCI cohort (15.8% vs. 32.2%, p < 0.001; 7.4% vs. 14.2%, p < 0.001, respectively). After adjusting for baseline characteristics, hospitalizations that included pPCI had 25% greater odds of unplanned 30-day readmission (adjusted odds ratio [aOR]: 1.25, 95% confidence interval [CI]: 1.12-1.39, p < 0.001) and 49% lower odds of in-hospital mortality during index hospitalization (aOR: 0.51, 95% CI: 0.46-0.56, p < 0.001). Heart failure was the most common cause of readmission in both cohorts followed by myocardial infarction.
Conclusions
In nonagenarians with STEMI, pPCI is associated with slightly higher 30-day readmission but significantly lower mortality during index hospitalization and during 30-day readmission than no pPCI. Given the overwhelming mortality benefit with pPCI, further research is necessary to optimize the utilization of pPCI while reducing readmissions following STEMI in nonagenarians.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 May 2022; epub ahead of print

Preclosure of large bore venous access sites in patients undergoing transcatheter mitral replacement and repair.

Mohammed M, Nona P, Abou Asala E, Chiang M, ... Eng M, Villablanca PA
Objective
We aim to report on the efficacy and safety of large bore venous access (LBVA) preclosure with Perclose™ (Abbott Vascular Devices) suture-mediated device use following transcatheter edge-to-edge (TEER) and replacement (TMVR).
Background
Patients requiring TEER and TMVR require LBVA. Clinical outcome data on the use of suture-mediated devices for LBVA site closure are limited.
Methods
Between 2012 and 2019, 354 consecutive high-risk patients with mitral valvular heart disease underwent TEER (n = 287) with MitraClip and TMVR (n = 67) with Edwards Sapien Valves. Patients had LBVA with 24 or 16 French sheaths. All patients underwent preclosure of LBVA except for one that underwent manual hemostasis.
Results
There were no closure device failures. None of the cases required surgical repair of the access site following venous preclosure. Two cases had large hematomas (>6 cm) following Perclose in each group. Six cases had small hematomas (<6 cm and >2 cm) with three in each group. There was one major bleeding using Mitral Valve Academic Research Consortium 2 definition (retroperitoneal bleed from arterial puncture) unrelated to the venous closure. Transfusion related to vascular access complication was required in five cases. There were two immediate acute deep venous thromboses postprocedure; one of which occurred after preclosure. There were no arteriovenous malformations, pseudoaneurysms, or access site infections reported following Perclose.
Conclusion
In this large sample size analysis, Proglide preclosure technique is a feasible and safe alternative approach to achieving hemostasis after removal of LBVA sheaths in patients undergoing TEER and TMVR. Randomized trials are needed to compare the different modalities of hemostasis.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 May 2022; epub ahead of print

Right ventricular hematoma: A rare but potentially fatal complication of percutaneous coronary artery intervention.

van Hattem VAE, Otterspoor LC, Lipsic E, Vlaar PJJ
Right ventricular hematoma secondary to coronary artery perforation during the percutaneous coronary intervention (PCI) is a rare complication. Nevertheless, with the growth of complex PCIs, including chronic total occlusion procedures, this complication may increase in frequency. We describe three cases of subepicardial right ventricular hematoma after complex right coronary artery PCI with different outcomes. Two cases were successfully managed with medication only. One case was managed with medication and pericardial drainage, unfortunately with a fatal outcome. All cases emphasize the need for awareness concerning this complication, which warrants prompt diagnosis and adequate therapy.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 12 May 2022; epub ahead of print

Transcatheter aortic valve implantation with the novel-generation Navitor device: Procedural and early outcomes.

Corcione N, Berni A, Ferraro P, Morello A, ... Giovannelli F, Giordano A
Transcatheter aortic valve implantation (TAVI) has proved beneficial in patients with severe aortic stenosis, especially when second-generation devices are used. We aimed at reporting our experience with Navitor, a third-generation device characterized by intrannular, large cell, and cuffed design, as well as high deliverability and minimization of paravalvular leak. Between June and December 2021, a total of 39 patients underwent TAVI with Navitor, representing 20% of all TAVI cases. Mean age was 80.0 ± 6.7 years, and 14 (36.8%) women were included. Severe aortic stenosis was the most common indication to TAVI (37 [97.4%] cases), whereas 2 (5.3%) individuals were at low surgical risk. Device and procedural success was obtained in all patients, with a total hospital stay of 6.6 ± 4.5 days. One (2.9%) patient required permanent pacemaker implantation, but no other hospital events occurred. At 1-month follow-up, a cardiac death was adjudicated in an 87-year-old man who had been at high surgical risk. Echocardiographic follow-up showed no case of moderate or severe aortic regurgitation, with mild regurgitation in 18 (47%), and none or trace regurgitation in 20 (53%). The Navitor device, thanks to its unique features, is a very promising technology suitable to further expand indications and risk-benefit profile of TAVI.

Catheterization and Cardiovascular Interventions© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 12 May 2022; epub ahead of print

Anomalous coronary artery in Tetralogy of Fallot-Feasibility of right ventricular outflow tract stenting as initial palliation.

Afifi ARSA, Mehta C, Bhole V, Chaudhari M, ... Jones TJ, Stumper O
This study addresses the outcome of right ventricle outflow tract (RVOT) stenting in Tetralogy of Fallot (ToF) with anomalous coronaries crossing the RVOT. RVOT stenting in ToF patients has emerged as an alternative to Blalock Taussig shunting. This is a single center study of patients who underwent RVOT stenting for symptomatic ToF at Birmingham Children\'s Hospital between 2005 and 2020. A total of 122 patients underwent RVOT stenting as initial palliation over a 15-year period, 10 patients had anomalous coronaries crossing the RVOT (study group) and 112 not (comparative group). Median age of the study group was 72.5 days (interquartile range [IQR]: 28-103) with a weight of 4.7 kg (IQR: 3.5-4.9). No significant differences were found between the two groups regarding the patients\' weights and ages, procedure and screening times, or hospital stay. Four had valve sparing stenting. Oxygen saturations increased from a median of 75.5% (IQR: 70-82) to 94.5% (IQR: 90-95), p < 0.002. Postprocedure median hospital stay was 3 days (IQR: 2-6). Six patients underwent interstage catheterization reintervention and one needed early surgical palliation due to stent suboptimal position. Complete repair could be delayed for a median of 11.1 months (IQR: 5.6-19.2). At surgical repair, the patients had a median age of 12.3 months (IQR: 7.5-25.6) and weight of 7.7 kg (IQR: 6.8-10.8). There were no deaths. RVOT stenting in ToF with anomalous coronaries is safe and effective. Dilatable stents should be used when two-stage delayed conduit repair is the default approach.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 11 May 2022; epub ahead of print

Clinical impact of FFR-guided PCI compared to angio-guided PCI from the France PCI registry.

Adjedj J, Morelle JF, Saint Etienne C, Fichaux O, ... Range G, all France PCI investigators
Objectives
We sought to compare, in a national French registry (FrancePCI), the clinical impact of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) compared with angio-guided PCI at 1 year.
Background
FFR has become the invasive gold standard to quantify myocardial ischemia generated by a coronary stenosis in patients with chronic coronary syndrome, but in clinical practice it is still underutilised to guide PCI compared to angiography (angio).
Methods
We extracted from the FrancePCI database all chronic coronary syndrome patients treated with PCI for coronary stenosis <90% between 2014 and 2019. Our composite clinical endpoint was the rate of major adverse clinical events (MACE).
Results
Fourteen thousand three hundred eighty-four patients with 1-year clinical follow-up were included. Among them, 13,125 had angio-guided PCI (91%) and 1259 (9%) had FFR-guided PCI. We observed a significantly higher rate of MACE in the angio-guided group versus the FFR-guided group: 1478 (11.3%) versus 100 (7.9%) (p < 0.0001), respectively, with hazard ratio (HR) of 1.440, 95% confidence interval (CI) [1.211-1.713] (p = 0.0004). This result was driven by the higher occurrence of death in the angio-guided group versus the FFR-guided-group: 506 (3.9%) versus 17 (1.4%) (p < 0.0001), respectively, with HR of 2.845, 95% CI [2.099-3.856] (p < 0.0001). After adjustment for potential confounding factors, HRs were 1.287, 95% CI [1.028-1.613] (p = 0.028) for MACE and 2.527, 95% CI [1.452-4.399] (p = 0.001) for death. No significant differences between angio-guided PCI and FFR-guided PCI were observed for other clinical endpoints.
Conclusions
FFR-guided PCI improves outcome at 1 year compared to angio-guided PCI with a reduction of 64% of death.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 11 May 2022; epub ahead of print

Atrial mitral regurgitation: Characteristics and outcomes of transcatheter mitral valve edge-to-edge repair.

Simard T, Reddy YNV, Thaden JJ, Padang R, ... Rihal CS, Eleid MF
Background
Mitral transcatheter edge-to-edge repair (MTEER) is an established therapeutic approach for mitral regurgitation (MR). Functional mitral regurgitation originating from atrial myopathy (A-FMR) has been described.
Objectives
We sought to assess the clinical, echocardiographic and hemodynamic considerations in A-FMR patients undergoing MTEER.
Methods
From 2014 to 2020, patients undergoing MTEER for degenerative MR (DMR), functional MR (FMR), and mixed MR were assessed. A-FMR was defined by the presence of MR > moderate in severity; left ventricular (LV) ejection fraction (LVEF) ≥ 50%; and severe left atrial (LA) enlargement in the absence of LV dysfunction, leaflet pathology, or LV tethering. The diagnosis of A-FMR (vs. ventricular-FMR [V-FMR]) was confirmed by three independent echocardiographers. Baseline characteristics, procedural outcomes as well as clinical and echocardiographic follow-up are reported. Device success was defined as final MR grade ≤ moderate; MR reduction ≥1 grade; and final transmitral gradient <5 mmHg.
Results
306 patients underwent MTEER, including DMR (62%), FMR (19%), and mixed MR (19%). FMR cases included 37 (63.8%) V-FMR and 21 (36.2%) A-FMR. Tricuspid regurgitation (≥ moderate) was higher in A-FMR (80.1%) compared to V-FMR (54%) and DMR (42%). Device success did not significantly differ between A-FMR and V-FMR (57% vs. 73%, p = 0.34) or DMR (57% vs. 64%, p = 1.0). The A-FMR cohort was less likely to achieve ≥3 grades of MR reduction compared to V-FMR (19% vs. 54%, p = 0.01) and DMR (19% vs. 49.7%, p = 0.01). Patients with V-FMR and DMR demonstrated significant reductions in mean left atrial pressure (LAP) and peak LA V-wave, though A-FMR did not (LAP -0.24 ± 4.9, p = 0.83; peak V-wave -1.76 ± 9.1, p = 0.39). In follow-up, echocardiographic and clinical outcomes were similar.
Conclusions
In patients undergoing MTEER, A-FMR represents one-third of FMR cases. A-FMR demonstrates similar procedural success but blunted acute hemodynamic responses compared with DMR and V-FMR following MTEER. Dedicated studies specifically considering A-FMR are needed to discern the optimal therapeutic approaches.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 10 May 2022; epub ahead of print

Iso-osmolar versus low-osmolar contrast media and outcomes after percutaneous coronary intervention: Insights from the VA CART Program.

Jovin IS, Warsavage TJ, Plomondon ME, Grunwald GK, ... Brilakis ES, Azzalini L
Objectives
To assess whether contrast media type is associated with outcomes in veterans undergoing percutaneous coronary intervention (PCI).
Background
There is uncertainty about the impact of iso-osmolar contrast medium (IOCM) versus low-osmolar contrast medium (LOCM) on acute kidney injury (AKI) and other major adverse renal or cardiovascular events (MARCE) after PCI. We assessed the association between contrast media type and MARCE in patients who underwent PCI within the Veterans Administration Healthcare System.
Methods
We reviewed PCIs performed between 2009 and 2019 using data from the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program. The primary endpoint was MARCE, a composite of myocardial infarction, stroke, all-cause death, AKI, and dialysis onset at 30 days.
Results
The analysis cohort consisted of 50,389 patients of whom 25,555 received LOCM and 24,834 received IOCM. There was significant variation in contrast type across sites. After adjustment for comorbidities, no significant association between contrast media type and MARCE was observed in both site-unadjusted (odds ratio [OR] for IOCM: 0.99; 95% confidence interval [CI]: 0.92-1.08; p = 0.97) and site-adjusted (OR: 1.06; 95% CI: 0.95-1.18; p = 0.30) analyses. Similar results were obtained when contrast volume was imputed or the data was subset to individuals with available contrast volume.
Conclusion
In a large cohort of veterans undergoing PCI, we found considerable site variation in the type of contrast media used but no significant association between contrast media type and the incidence of MARCE, both before and after adjustment for the site.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 May 2022; epub ahead of print

Impact of proton pump inhibitors on efficacy of antiplatelet strategies with ticagrelor or aspirin after percutaneous coronary intervention: Insights from the GLOBAL LEADERS trial.

Ono M, Onuma Y, Kawashima H, Hara H, ... Serruys PW, GLOBAL LEADERS trial investigators
Background
Several studies have suggested that proton pump inhibitors (PPIs) may reduce the antiplatelet effects of clopidogrel and/or aspirin, possibly leading to cardiovascular events.
Aims
We aimed to investigate the association between PPI and clinical outcomes in patients treated with ticagrelor monotherapy or conventional antiplatelet therapy after percutaneous coronary intervention (PCI).
Methods
This is a subanalysis of the randomized GLOBAL LEADERS trial, comparing the experimental antiplatelet arm (23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT]) with the reference arm (12-month aspirin monotherapy following 12-month DAPT) after PCI. Patient-oriented composite endpoints (POCEs: all-cause mortality, myocardial infarction, stroke, or repeat revascularization) and its components were assessed stratified by PPI use as a time-dependent covariate in patients with the experiment or reference antiplatelet arm.
Results
Among 15,839 patients, 2115 patients (13.5%) experienced POCE at 2 years. In the reference arm, the use of PPIs was independently associated with POCE (hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 1.12-1.44) and its individual components, whereas it was not in the experimental arm (HR: 1.04; 95% CI: 0.92-1.19; p_interaction  = 0.035). During the second-year follow-up, patients taking aspirin with PPIs had a significantly higher risk of POCE compared to those on aspirin without PPIs (HR: 1.57; 95% CI: 1.27-1.94), whereas the risk did not differ significantly irrespective of PPI in ticagrelor monotherapy group (HR: 1.03; 95% CI: 0.83-1.28; p_interaction  = 0.008).
Conclusions
In contrast to conventional antiplatelet strategy, there were no evidence suggesting the interaction between ticagrelor monotherapy and PPIs on increased cardiovascular events, which should be confirmed in further studies.
Clinical trial registration
URL: https://clinicaltrials.gov.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 May 2022; epub ahead of print

Valve-in-valve transcatheter aortic valve replacement or re-surgical aortic valve replacement in degenerated bioprostheses: A systematic review and meta-analysis of short and midterm results.

Bruno F, Elia E, D\'Ascenzo F, Marengo G, ... De Ferrari GM, Conrotto F
Introduction
Despite limited to short and midterm outcomes, valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) has emerged as a valid alternative to re-surgical aortic valve replacement (re-SAVR) for high- and intermediate-risk patients with degenerated surgical bioprosthesis.
Methods
All studies comparing multivariate adjustment between ViV TAVI and re-SAVR were screened. The primary end-points were all-cause and cardiovascular (CV) mortality at 30 days and at Midterm follow-up. Short-term complications were the secondary endpoints.
Results
We obtained data from 11 studies, encompassing 8570 patients, 4224 undergoing ViV TAVI, and 4346 re-SAVR. Four studies included intermediate-risk patients and seven high-risk patients. 30-day all-cause and CV mortality were significantly lower in ViV (odds ratio [OR] 0.43, 95% confidence intervals [CIs] 0.29-0.64 and OR 0.44, 0.26-0.73 respectively), while after a mean follow-up of 717 (180-1825) days, there was no difference between the two groups (OR 1.04, 0.87-1.25 and OR 1.05, 0.78-1.43, respectively). The risk of stroke (OR 1.03, 0.59-1.82), MI (OR 0.70, 0.34-1.44), major vascular complications (OR 0.92, 0.50-1.67), and permanent pacemaker implantation (OR 0.67, 0.36-1.25) at 30 days did not differ, while major bleedings and new-onset atrial fibrillation were significantly lower in ViV patients (OR 0.41, 0.25-0.67 and OR 0.23, 0.12-0.42, respectively, all 95% CIs).
Conclusions
In high- and intermediate-risk patients with degenerated surgical bioprostheses, ViV TAVI is associated with reduced short-term mortality, compared with re-SAVR. Nevertheless, no differences were found in all-cause and CV mortality at midterm follow-up. PROSPERO CRD42021226488.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Apr 2022; epub ahead of print

Optical coherence tomography assessment of acute thrombogenicity at bifurcation sites using different stenting techniques: A porcine arteriovenous shunt study.

Dan K, Bhogal S, Kuku KO, Melaku GD, ... Waksman R, Garcia-Garcia HM
Objectives
We aimed to compare bare-metal stents (BMS), durable-polymer everolimus-eluting stents (DP-EES), and abluminal biodegradable-polymer sirolimus-eluting stents (ABP-SES) in the bifurcation model setup.
Background
The mechanism of thrombogenicity, which differs among second-generation stents implanted using double-kissing (DK) crush or culotte stenting techniques, remains unclear. We have shown previously that setting up a porcine arteriovenous shunt model is feasible and useful to assess thrombogenicity at vessel bifurcation points.
Methods
Six porcine shunt models were prepared for the comparison between DK crush and culotte stenting techniques using BMS, DP-EES, and ABP-SES. Intracoronary imaging with high-resolution optical coherence tomography (OCT) was performed to evaluate the thrombogenicity in different stent types in the bifurcation stenting model and was evaluated by a core lab.
Results
Culotte stenting demonstrated more thrombogenicity at the proximal main branch (MB) with DP-EES, side branch (SB) with BMS, and the bifurcation site irrespective of the stent type, while DK crush technique exhibited thrombogenicity only at SB with BMS and ABP-SES. OCT analysis revealed malapposition of DP-EES in the proximal MB with culotte stenting. Stent expansion was generally larger in ABP-SES than BMS and DP-EES.
Conclusions
The study provides hypothesis-generating findings in distinct thrombogenicity of bifurcation stenting with DP- or ABP-coated drug-eluting stents.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Apr 2022; epub ahead of print

Case series of closure devices complications.

Chami T, Janus SE, Shishehbor MH, Li J
Vascular closure devices (VCD) are effective at achieving hemostasis. VCD failure is attributed to underlying arterial disease, leading to a hazardous situation for obtaining contralateral femoral access. Radial-to-peripheral (R2P) access has emerged as a safe option to rescue these procedural complications. Here, we present two cases of VCD failure rescue utilizing R2P and outline this approach step-by-step.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Apr 2022; epub ahead of print

Regulatory strategies for early device development and approval.

Holmes DR, Geoffrion R, Hunt J, Hance RC, ... Mack MJ, Kaplan AV
The development of new technology to treat unmet clinical needs is an important component of modern cardiovascular disease. The need for this has been emphasized in the past several years beginning with the Food and Drug Administration (FDA) guidance document on Early Feasibility Studies in 2012 and then the 21st Century Cures legislation. A number of steps need to be considered in this process by the stakeholders involved including physician innovators and scientists, professional societies such as Society for Cardiovascular Angiography & Interventions, regulatory agencies, and medical device companies. This article focuses on the early iterative steps required to optimize the process and achieve the goal of timely efficient innovation and device development in cardiovascular disease.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Apr 2022; epub ahead of print

Novel oral anticoagulants versus vitamin K antagonists in patients with atrial fibrillation after transcatheter aortic valve replacement: A systematic review and meta-analysis.

Memon MM, Siddiqui AA, Amin E, Shaikh FN, ... Doukky R, Krasuski RA
Background
The efficacy and safety of novel oral anticoagulants (NOACs) compared to the current guideline-recommended vitamin K antagonists (VKAs) in atrial fibrillation (AF) patients undergoing transcatheter aortic valve replacement (TAVR) has not been well established. We pooled evidence from all available studies to assess the risks and benefits of this drug class.
Methods
We queried electronic databases (MEDLINE, Scopus, and Cochrane central) up until January 28th, 2022 for studies comparing NOACs to VKAs in AF patients undergoing TAVR. Results from studies were presented as risk ratios (RR) and pooled using a random-effects model. Subgroup analysis by study design and meta-regression analysis were performed to explore heterogeneity.
Results
A total of 12 studies (3 RCTs and 9 observational) containing 12,203 patients (mean age 81.2 years; 50.5% men) were identified and included in the analysis. Pooled analysis revealed no significant difference between NOACs and VKAs in terms of stroke or systemic embolism (RR: 0.78; p = 0.18), major bleeding (RR: 0.84; p = 0.32), intracranial hemorrhage (RR 0.61; p = 0.06), all-cause mortality (RR: 0.69; p = 0.07), and myocardial infarction (RR: 1.60; p = 0.24) at a mean length of follow-up of 15.1 months. RCTs and observational studies did not significantly differ across outcomes on subgroup analysis. Meta-regression analysis found heterogeneity in all-cause mortality to be significantly explained by percentage of males (coefficient: 0.049, p = 0.007), mean age (coefficient: 0.221, p < 0.001), and CHA2DS2-VASc score (coefficient: -1.657, p < 0.001).
Conclusions
This meta-analysis suggests that outcomes with NOACs do not significantly differ compared to VKAs following TAVR in patients with AF.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 27 Apr 2022; epub ahead of print

Spontaneous coronary artery dissection and exogenous estrogen in a transgender female.

Hirsch K, Yogeswaran V, Dean LS
We report the case of a 37-year-old transgender patient with a history of orchiectomy on gender-affirming estrogen therapy who was hospitalized with an acute onset of chest pain with a resolution shortly after the presentation. On presentation, the patient had a rapid rise in troponin level and was urgently taken to the cardiac catheterization lab where spontaneous coronary artery dissection was diagnosed and treated with cutting balloon angioplasty and medical management. After a multidisciplinary discussion, the only notable risk factor was estrogen supplementation after gender reassignment surgery. To our knowledge, this is the only report of a male to female transgender patient reported to have spontaneous coronary artery dissection.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 21 Apr 2022; epub ahead of print

Guide-Extension Carlino: A novel technique for crossing a microcatheter uncrossable proximal cap during chronic total occlusion interventions.

Karacsonyi J, Brilakis ES, Chandwaney RH
Balloon and microcatheter uncrossable chronic total occlusions can be challenging to treat. We present a novel technique for treating such lesions through contrast injection via a guide catheter extension wedged against the proximal cap. We named this technique \"guide-extension Carlino.\"

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 21 Apr 2022; epub ahead of print

Novel method for left ventricular unloading utilizing percutaneous pulmonary artery drainage in cardiorespiratory failure due to COVID-19 infection.

Kumar K, Coonse K, Zakhary B, Cigarroa JE
Left ventricular (LV) unloading is an important concept in patients undergoing peripheral venoarterial extracorporeal membrane oxygenation (VA-ECMO). We present a case of a 32-year-old male in acute cardiorespiratory collapse due to coronavirus disease (COVID-19) who underwent VA-ECMO cannulation in the setting of cardiogenic shock and acute respiratory distress syndrome. Due to inability to utilize percutaneous LV assist device (pLVAD) for LV unloading due to small end diastolic dimension, alternative strategies were explored. A traditionally utilized right ventricular support device, the ProTek Duo (TandemLife, Pittsburgh, PA), was utilized to drain the pulmonary artery, leading to improvement in parameters for cardiogenic shock. To our knowledge, this is the first case in which a ProTek Duo has been utilized in conjunction with VA-ECMO to provide LV unloading in support of a patient in cardiogenic shock. This method can be employed in future challenging situations where pLVAD is not feasible.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 21 Apr 2022; epub ahead of print

Safety gaps in medical team communication: Closing the loop on quality improvement efforts in the cardiac catheterization lab.

Doorey AJ, Turi ZG, Lazzara EH, Casey M, ... Garratt KN, Weintraub WS
Closed-loop communication (CLC) is a fundamental aspect of effective communication, critical in the cardiac catheterization laboratory (cath lab) where physician orders are verbal. Complete CLC is typically a hospital and national mandate. Deficiencies in CLC have been shown to impair quality of care. Single center observational study, CLC for physician verbal orders in the cath lab were assessed by direct observation during a 5-year quality improvement effort. Performance feedback and educational efforts were used over this time frame to improve CLC, and the effects of each intervention assessed. Responses to verbal orders were characterized as complete (all important parameters of the order repeated, the mandated response), partial, acknowledgment only, or no response. During the first observational period of 101 cases, complete CLC occurred in 195 of 515 (38%) medication orders and 136 of 235 (50%) equipment orders. Complete CLC improved over time with various educational efforts, (p < 0.001) but in the final observation period of 117 cases, complete CLC occurred in just 259 of 328 (79%) medication orders and 439 of 581 (76%) equipment orders. Incomplete CLC was associated with medication and equipment errors. CLC of physician verbal orders was used suboptimally in this medical team setting. Baseline data indicate that physicians and staff have normalized weak, unreliable communication methods. Such lapses were associated with errors in order implementation. A subsequent 5-year quality improvement program resulted in improvement but a sizable minority of unacceptable responses. This represents an opportunity to improve patient safety in cath labs.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Apr 2022; epub ahead of print

Bedside intra-aortic balloon pump insertion in cardiac intensive care unit: A single-center experience.

Baldetti L, Beneduce A, Boccellino A, Pagnesi M, ... Sacchi S, Cappelletti AM
Background
In contemporary Cardiac Intensive Care Unit (CICU), bedside intra-aortic balloon pump (IABP) insertion under echocardiographic guidance may be an attractive option for selected patients with cardiogenic shock (CS). Currently available data on this approach are limited.
Aim
This study aimed to assess the feasibility and safety of bedside IABP insertion, as compared to fluoroscopic-guided insertion in the Catheterization Laboratory (CathLab), and to describe the clinical features of patients receiving bedside IABP insertion using a standardized technique in real-world CICU practice.
Methods
We prospectively evaluated all patients admitted the CICU who received transfemoral IABP between June 2020 and October 2021. The overall study cohort was divided according to implant strategy in bedside and CathLab groups. The primary outcome was correct radiographic IABP positioning at the first bedside chest X-ray obtained after insertion. Secondary outcomes included IABP-related complications.
Results
Among 115 patients, bedside IABP insertion was performed in 35 (30.4%) cases, mainly presenting with CS-related to acute decompensated heart failure (ADHF) (68.6 vs 33.8%; p < 0.001), with lower LVEF, higher proportion of right ventricular involvement and higher need of inotropes/vasopressors, compared to those receiving CathLab insertion. Bedside IABP insertion resulted feasible and safe, with similar rates of correct IABP positioning (82.9 vs. 82.5%; p = 0.963) and IABP-related major vascular complications (5.7 vs. 5.0%; p = 0.874), as compared to CathLab positioning.
Conclusion
This study suggests the feasibility and safety of bedside IABP insertion, which could be of relevant interest in patients with ADHF-related CS who may not need coronary angiography or other urgent CathLab procedures.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Apr 2022; epub ahead of print

Reasons for lesion uncrossability as assessed by intravascular ultrasound.

Salem H, Mintz GS, Matsumura M, Zhang M, ... Karmpaliotis D, Maehara A
Objectives
The purpose of the current study was to use intravascular ultrasound (IVUS) to clarify anatomical and morphological lesion characteristics of uncrossable lesions.
Background
Uncrossable lesions are not always severely calcified. The prevalence of uncrossable lesions that are nonseverely calcified as well as other mechanisms for uncrossability has not been well clarified.
Methods
A total of 252 de novo uncrossable lesions in native coronary arteries that underwent either rotational or orbital atherectomy due to inability of any balloon to cross the lesion and 38 lesions with severe calcium in which IVUS crossed preatherectomy were included. Severe calcium is defined as maximum arc of calcium ≥270°.
Results
Severe calcification was absent in 16% of uncrossable lesions, 83% of which had a significant vessel bend. Compared with crossable lesions with severe calcium, uncrossable lesions with severe calcium more often had a bend in the vessel (71% vs. 21%, p < 0.001) and a longer length of continuous severe calcium (median length of calcium ≥270° 3.8 mm vs. 1.9 mm, p = 0.001). Other than severe calcium (especially long continuous calcium) or a bend in the vessel, anatomical factors associated with uncrossabilty were aorto-ostial lesion location and small vessels.
Conclusions
Uncrossable lesions are not always severely calcified. The interaction of lesion morphology (continuous long and large arcs of calcium) and vessel geometry (bend in the vessel or ostial lesion location) affect lesion crossability.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Apr 2022; epub ahead of print

Single versus double Perclose techniques for vascular closure during transfemoral transcatheter aortic valve replacement.

Hollowed J, Akhondi A, Rabbani A, Oncel D, ... Shemin R, Aksoy O
Introduction
The preferred approach for transcatheter aortic valve replacement (TAVR) is transfemoral. There has been widespread adoption of the Perclose Proglide^TM device for vascular closure. Typically, two devices are deployed before upsizing the access sheath in the \"preclose technique.\" Prior investigations have compared the use of a single device versus double device technique, but none have shown significant clinical benefit to either approach.
Methods
Five hundred and six patients underwent transfemoral TAVR (TF-TAVR) with single or double Perclose devices for vascular closure from July 2015 to February 2020. A retrospective review was conducted, and propensity-matched analyses were used to account for differences in baseline characteristics.
Results
In the matched analysis, there were 251 patients in the single Perclose group and 238 in the double. There was a statistically significant improvement in overall procedural success using the single closure device (94.6% vs. 88.5%, p = 0.009) This was defined as intraprocedural hemostatic control, lack of contrast extravasation, arterial dissection, occlusion, or stenosis >50% in the final crossover angiogram, as well as unimpaired limb perfusion without claudication throughout the index hospitalization. There was also a significant improvement in arterial dissection rates (0.6% vs. 4.6%, p = 0.004), stenosis >50% (1.3% vs. 4.4%, p = 0.028), and Valve Academic Research Consortium major vascular complications (1.8% vs. 4.9%, p = 0.038).
Conclusion
A single Perclose device is a safe means of vascular closure during TF-TAVR and may have important clinical benefits compared to the commonly used two-device technique.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Apr 2022; epub ahead of print

Efficacy of larger valve sizing with underfilling in balloon-expandable transcatheter aortic valve replacement.

Kawaguchi T, Miyoshi T, Hayashi M, Ishizu K, ... Shirai S, Ando K
Objectives
To investigate the efficacy and safety of larger valve sizing beyond the commercially recommended annular range in transcatheter aortic valve replacement (TAVR) with balloon-expandable transcatheter heart valve (THVs).
Background
The clinical implications of larger balloon-expandable THV implantation with underfilling are poorly evaluated.
Methods
This retrospective study included 692 consecutive patients who underwent TAVR with SAPIEN3. A total of 271 patients who underwent SAPIEN 3 implantation were analyzed based on three border zones (Zone 1: 300-345 mm² , 23 vs. 20 mm; Zone 2: 400-430 mm² , 26 vs. 23 mm; Zone 3: 500-546 mm² , 29 vs. 26 mm). The primary endpoint was the effective orifice area (EOA) assessed by echocardiography at 1 year, and secondary endpoints were a 30-day mortality rate, procedural complications during TAVR, and a composite of death from any cause and heart failure requiring rehospitalization at 1 year.
Results
At 1-year follow-up, the EOA in the larger valve groups was greater than that in the recommended valve group in each zone (Zone 1: 1.45 ± 0.03 vs. 1.06 ± 0.06 cm² , p < 0.001; Zone 2: 1.83 ± 0.05 vs. 1.41 ± 0.05 cm² , p < 0.001; Zone 3: 1.93 ± 0.07 vs. 1.69 ± 0.07 cm² , p = 0.02). No significant difference in the secondary endpoint was observed in any of the zones.
Conclusions
Implantation of the out-of-range larger SAPIEN 3 THVs with underfilling was associated with greater EOA at the 1-year follow-up and feasible in the selected patients.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Apr 2022; epub ahead of print

Transcatheter closure of fenestrated atrial septal aneurysm in children: Feasibility and long-term results.

Mahmoud HT, Gaio G, Giordano M, Pizzuto A, ... Russo MG, Santoro G
Background
To date, extensive experience in transcatheter closure of fenestrated atrial septal aneurysm (ASA) in the pediatric population is limited.
Methods
To report on procedural feasibility, efficacy, and long-term outcome, we enrolled all children submitted to an attempt of transcatheter closure of fenestrated ASA at two, large volume, pediatric cardiology units (Naples and Massa, Italy) between April 2000 to May 2020.
Results
This retrospective study included 139 patients (median age 9 years [range 2-18] and weight 36 kg [range 10-102]); 19 (13.7%) children were ≤20 kg (range 10-20) and 14 (10.1%) were ≤5 years old. Single perforation was observed in 28 patients (20.1%), while 111 patients (79.9%) had multifenestrated ASA. The median size of the main defect was 15 mm (range 6-34) and 25 patients (18%) had a defect ≥20 mm. The procedural success rate was 99% (95% confidence interval [CI]: 94.9-99.8) using a single device in 75 (69%), two devices in 31 (28%), and three devices in 3 (3%) cases. Early minor adverse events (AEs) occurred in four patients (2.8%). Late minor AEs were recorded in one patient (0.7%) over a median follow-up of 5 years ([range 0-18 years; total 890.2 person-years, and with 30 patients (22%) followed ≥10 years). Neither mortality nor major AEs were recorded. Freedom from AEs was 99.1% at 10-15 years (95% CI: 93.5-99.8%), without any difference according to atrial septum anatomy or patient age and weight.
Conclusion
Transcatheter closure of fenestrated ASA is technically feasible and effective in children with excellent long-term outcomes.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Apr 2022; epub ahead of print

Percutaneous balloon mitral valvuloplasty using veno-arterial loop and neuro-embolic protection for mitral stenosis with thrombus.

Hou S, Pan W, Zhou D, Ge J
Percutaneous balloon mitral valvuloplasty (PBMV) is not traditionally suitable for patients with mitral stenosis (MS) and left atrium (LA) thrombus. Moreover, PBMV cannot be performed in patients with LA thrombus not resolving after anti-coagulation treatment. Here we present a case of PBMV using a novel technique employing both a veno-arterial loop and neuro-embolic protection, in a patient with MS and LA thrombus resistant to warfarin therapy. The patient successfully underwent PBMV without any complications.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Apr 2022; epub ahead of print

Temporal trends in transcatheter aortic valve replacement use and outcomes by race, ethnicity, and sex.

Yong CM, Jaluba K, Batchelor W, Gummipundi S, Asch SM, Heidenreich P
Objectives
To identify trends in transcatheter aortic valve replacement (TAVR) use and outcomes by race (non-Hispanic White, Black), ethnicity (Hispanic), and sex over time.
Background
Despite rapid growth in TAVR use over time, our understanding of its use and outcomes among males and females of underrepresented racial/ethnic groups remains limited.
Methods
A retrospective analysis of hospitalizations from 2013 to 2017 from the Healthcare Cost and Utilization Project database was performed.
Results
White patients comprised 65% (n = 2.16 × 10⁷ ) of all hospitalizations, yet they comprised 83% (n = 176,887) of the admissions for aortic stenosis (p < 0.0001). Among 91,693 hospitalizations for aortic valve replacement, 64,069 were surgical (34.0% female, 7.0% Hispanic, and 5.9% Black) and 27,624 were transcatheter (46.6% female, 4.5% Hispanic, and 4.4% Black). Growth in TAVR volumes was the slowest among minorities and females. Hispanic males, Hispanic females, and White females had the highest in-hospital mortality (2.7%-3.3%; compared to White males, adjusted odds ratio: Hispanic males 1.9 [1.2-3.0], Hispanic females 1.9 [1.2-3.1], and White females 1.4 [1.2-1.7]). Despite less baseline vascular disease, females of all races/ethnicities had more vascular complications than men (female 5% vs. male 3.5%, p ≤ 0.001). Further adjustment for vascular complications only partially attenuated mortality differences. Black and Hispanic patients had a longer mean length of hospital stay than White patients, which was most pronounced among females. Pacemaker requirements were consistently low among all groups.
Conclusion
Differences in TAVR growth and outcomes by race, ethnicity, and sex over time highlight areas for focused efforts to close gaps in minimally invasive structural heart disease care.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Apr 2022; epub ahead of print

Transcatheter implantation of covered stents serving as extravascular conduits-Proof of a CT-based approach in three cases.

Ewert P, Eicken A, Tanase D, Georgiev S, ... Meierhofer C, Hörer J
Background
Covered stents perform similar to surgically implanted conduits, although the stents work inside of vessels. We present a computed tomography (CT)-based workflow for the implantation of covered stents as extravascular conduits.
Methods
We selected three different use cases: 1. Connecting a left-sided partially anomalous drainage of a pulmonary vein to the left atrium. 2. Bypassing an outgrown Dacron conduit in aortic recoarctation. 3. Re-directing hepatic venous blood to the left lung in a Fontan patient with heterotaxy, connecting the innominate vein to the right pulmonary artery like a right-sided cavopulmonary connection. By postprocessing and analyzing CT scans for planning and by the use of long needles under biplane fluoroscopy for the realization of the procedure, we projected and performed the exit of a long needle out of a vessel, the re-entering of a target vessel, and the bridging of the extravascular distance by implantation of covered stents.
Results
In all three cases, the covered stents were placed successfully, connecting vessels of 15-50 mm distance from each other with very good hemodynamic results. In one case, two stents were placed consecutively, overlapping each other to accomplish an exact fitting at the connection sites to the native vessels.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Apr 2022; epub ahead of print

Outcomes of emergency transcatheter aortic valve replacement in patients with cardiogenic shock: A multicenter retrospective study.

Piriou PG, Manigold T, Letocart V, Le Ruz R, ... Guérin P, Plessis J
Rescue transcatheter aortic valve replacement (TAVR) in patients with cardiogenic shock is challenging, and there is limited literature on these critical patients. The aim of this study was to determine the characteristics and outcomes of patients undergoing TAVR, feasibility and safety of the procedure, and 1-year mortality factors. Thirty-eight patients with severe aortic disease and cardiogenic shock admitted to two French hospitals from 2015 to 2019 were included. The patients were critical, 78.9% of them had a left ventricular ejection fraction of <30%, and all of them received inotropic support. \"Valve-in-valve\" procedures were performed in 15.8% and 13.2% underwent balloon aortic valvuloplasty before TAVR. Edwards Sapien3® and Medtronic CoreValve EvolutR® were used. The survival probability remained reasonable for patients with cardiogenic shock who underwent rescue TAVR. The 30-day mortality rate was 7.9% and 21.1% at 1 year. No patient died during the intervention. The procedure was safe, with few complications except for acute kidney failure, the development of a left bundle branch block, and the need for pacemaker implantation. Both functional and echocardiographic results were good at 1 year, although 29% of the patients underwent rehospitalization within 1 year. The development of a left bundle branch block was found to be a mortality risk factor. This procedure is a safe and effective therapy with acceptable survivorship in critically ill patients. The benefits to their quality of life should be evaluated in future studies, and the need for providing early cardiac resynchronization therapy must be emphasized.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Apr 2022; epub ahead of print

Age stratified sex-related differences in incidence, management, and outcomes of cardiogenic shock.

Osman M, Syed M, Kheiri B, Bianco C, ... Fonarow GC, Balla S
Background
There is a lack of data on age-stratified sex differences in the incidence, treatment, and outcomes of cardiogenic shock (CS). We sought to study these differences from a contemporary database.
Methods
Patients admitted with CS (2004-2018) were identified from the United States National Inpatient Sample. We compared CS (acute myocardial infarction-related cardiogenic shock [AMI-CS] and non-acute myocardial infarction-related cardiogenic shock [Non-AMI-CS]) incidence, management, and outcomes in males and females, stratified into four age groups (20-44, 45-64, 65-84, and ≥85 years of age). Propensity score matching (PSM) was used for adjustment.
Results
A total of 1,506,281 weighted hospitalizations for CS were included (AMI-CS, 39%; Non-AMI-CS, 61%). Across all age groups, females had a lower incidence of CS compared with males. After PSM and among the AMI-CS cohort, higher mortality among females compared with males was observed in the age groups 45-64 (28.5% vs. 26.3%) and 65-84 years (39.3% vs. 37.9%) (p < 0.01, for all). Among the Non-AMI-CS cohort, higher mortality among females compared with males was observed in the age groups 20-44 (33.5% vs. 30.5%), 45-64 (35.1% vs. 31.9%), and 65-84 years (41.7% vs. 40.3%) (p < 0.01, for all). Similar age-dependent differences in the management of CS were also observed between females and males.
Conclusions
Females have a lower incidence of CS regardless of age. Significant disparities in the management and outcomes of CS were observed based on sex. However, these disparities varied by age and etiology of CS (AMI-CS vs. Non-AMI-CS) with pronounced disparity among females in the age range of 45-84 years.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 07 Apr 2022; epub ahead of print

Adverse events and stroke prevention by interventional left atrial appendage occlusion in patients with low CHA DS -VASc score-results from the multicenter German LAARGE registry.

Fastner C, Brachmann J, Lewalter T, Zeymer U, ... Akin I, Ansari U
Background
Interventional left atrial appendage occlusion (LAAO) is routinely performed in patients with nonvalvular atrial fibrillation and contraindications to standard anticoagulation.
Aims
We investigated its role in patients at low stroke risk, and compared the effectiveness and safety in patients with low versus high risk.
Methods
LAARGE is a prospective registry depicting the clinical reality of LAAO. LAAO was conducted with different standard commercial devices, and follow-up period was 1 year. Patients with started procedure and documented CHA₂ DS₂ -VASc score were selected from the whole database.
Results
A total of 638 patients from 38 centers were divided into CHA₂ DS₂ -VASc score ≤2, i.e., low-risk group (10.2%), and >2, i.e., high-risk group (89.8%). The latter had a pronounced cardiovascular risk profile and preceding strokes (0% vs. 23.9%; p < 0.001). Implantation success was consistently high (97.6%), frequencies of intrahospital major adverse cardiac and cerebrovascular events (0% vs. 0.5%) and other major complications (4.6% vs. 4.0%) were low (each p = not significant [NS]). Numerous moderate complications were also observed in the low-risk patients (12.3% vs. 9.4%; p = NS). Frequencies of nonfatal strokes (0% vs. 0.7%) and severe bleedings (0% vs. 0.7%) were low (each p = NS). In a specig analysis, patients at very high risk of stroke (i.e., CHA₂ DS₂ -VASc score >4) did not have increased rates of complications or nonfatal strokes in the first year after the procedure.
Conclusions
Low-risk patients had no nonfatal strokes and major bleedings within 1 year after hospital discharge but had unexpectedly high rates of moderate procedural complications. The indication in these patients should be strictly defined based on an individual benefit-risk assessment.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 06 Apr 2022; epub ahead of print

Impact of diabetes on clinical outcomes after revascularization with the dual therapy CD34 antibody-covered sirolimus-eluting Combo stent and the sirolimus-eluting Orsiro stent.

Jakobsen L, Christiansen EH, Freeman P, Kahlert J, ... Hansen HS, Jensen LO
Objectives
To compare the efficacy and safety of the dual therapy CD34 antibody-covered sirolimus-eluting Combo stent (DTS) and the sirolimus-eluting Orsiro stent (SES) in patients with and without diabetes mellitus (DM) included in the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) X study.
Background
The incidence of target lesion failure (TLF) after treatment with modern drug-eluting stents has been reported to be significantly higher in patients with DM when compared to patients without DM. Thus, whether the results from the SORT OUT X study apply to patients with and without DM remains unknown.
Methods
In total 3146 patients were randomized to stent implantation with DTS (n = 1578; DM: n = 279) or SES (n = 1568; DM: n = 271). The primary end point, TLF, was a composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 1 year.
Results
At 1 year, the rate of TLF was increased in the DTS group compared to the SES group, both among patients with DM (9.3% vs. 4.8%; risk difference: 4.5%; incidence rate ratio: 1.99, 95% confidence interval [CI]: 1.02-3.90) and without DM (5.7% vs. 3.5%; incidence rate ratio: 1.67, 95% CI: 1.15-2.42). The differences were mainly explained by higher rates of TLR.
Conclusion
Compared to the SES, the DTS was associated with an increased risk of TLF at 12 months in patients with and without DM. 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 DM.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 06 Apr 2022; epub ahead of print

When coronary imaging and physiology are discordant, how best to manage coronary lesions? An appraisal of the clinical evidence.

Fernández-Peregrina E, Ahmad H, Mintz GS, Garcia-Garcia HM
Background
Discordant physiology and anatomy may occur when nonsevere angiographic stenosis has positive physiology as well as the opposite situation.
Aim
To underline the reasons behind the discrepancy in physiology and anatomy and to summarize the information that coronary imaging may add to physiology.
Methods
A review of the published literature on physiology and intravascular imaging assessment of intermediate lesions was carried out.
Results
The limitations of angiography, the possibility of an underlying diffuse disease, the presence of a \"grey zone\" in both techniques, the amount of myocardial mass that subtends the stenosis, and plaque vulnerability may play a role in such discrepancy. Intracoronary imaging has a poor diagnostic accuracy compared to physiology. However, it may add information about plaque vulnerability that might be useful in deciding whether to treat or not a certain lesion.
Conclusions
Coronary revascularization is recommended for patients with ischemia based on physiology. Intracoronary imaging adds information on plaque vulnerability and can help on the decision whether to revascularize or not a lesion.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 04 Apr 2022; epub ahead of print

Angiography-derived versus invasively-determined index of microcirculatory resistance in the assessment of coronary microcirculation: A systematic review and meta-analysis.

Fernández-Peregrina E, Garcia-Garcia HM, Sans-Rosello J, Sanz-Sanchez J, ... Tebaldi M, De Maria GL
Background
The index of microvascular resistance (IMR) is an established tool to assess the status of coronary microcirculation. However, the need for a pressure wire and hyperemic agents have limited its routine use and have led to the development of angiography-derived pressure-wire-free methods (angiography-derived IMR [IMRAngio]). In this review and meta-analysis, we aim to assess the global diagnosis accuracy of IMRAngio versus IMR.
Methods
A systematic review of the literature was performed. Studies directly evaluating IMRAngio versus IMR were considered eligible. Pooled values of diagnostic test and summary receiver operator curve were calculated.
Results
Seven studies directly comparing IMRAngio versus IMR were included (687 patients; 807 vessels). Pooled sensitivity, specificity, +likelihood ratio (LR), and -LR were 82%, 83%, 4.5, and 0.26 respectively. Pooled accuracy was 83% while pooled positive predictive value and negative predictive value were 76% and 85%, respectively. Comparable results were obtained when analyzing by clinical scenario (acute and nonacute coronary syndromes).
Conclusion
IMRAngio shows a good diagnostic performance for the prediction of abnormal IMR.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Apr 2022; epub ahead of print

Outcomes of rotational atherectomy followed by cutting balloon versus plain balloon before drug-eluting stent implantation for calcified coronary lesions: A meta-analysis.

Patel N, Bandyopadhyay D, Agarwal G, Chakraborty S, ... Mamas MA, Naidu SS
Objective
The aim of this study is to compare outcomes of rotational atherectomy and cutting balloon (RACB) versus rotational atherectomy and plain balloon (RAPB) before drug-eluting stent (DES) implantation in calcified coronary lesions.
Methods
Randomized controlled trials (RCT) and observational studies comparing RACB with RAPB were identified through a systematic search of published literature across multiple databases. Random effect meta-analysis was performed to compare the outcome between the two groups.
Results
Four studies were included in the meta-analysis (three observational and one RCT) involving a total of 315 patients. 166 patients had RACB, and 149 patients had RAPB before DES placement with a median follow-up of 11.5 months. Compared with patients who had RAPB there was no difference in MACE (composite of death, myocardial infarction, and target vessel revascularization) (odds ratio [OR]: 0.74; 95% confidence interval [CI]: 0.25-2.18], slow flow/no reflow (OR: 0.71; 95% CI: 0.23-2.16), all-cause mortality (OR: 2.02; 95% CI: 0.28-14.60), and device success rate (OR: 1.79; 95% CI: 0.28-11.18) in the RACB approach. There was a benefit towards less target lesion revascularization in the RACB group; however, this outcome was reported in two studies (OR: 0.29; 95% CI: 0.08-0.99). On meta-regression there was no association between age, sex, diabetes, or lesion location with MACE and all-cause mortality. The studies were homogenous across all outcomes.
Conclusion
RACB, as compared with RAPB, had a similar risk of MACE, all-cause mortality, device success, and complication, but a lower risk of target lesion revascularization.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Apr 2022; epub ahead of print

Transcatheter mitral valve repair in patient with atrial functional mitral regurgitation using novel DragonFly™ device.

Liu X, Chen Y, Lim DS, Wang J
We report the first case of transcatheter mitral valve repair with the novel DragonFly™ device, a transcatheter edge-to-edge mitral regurgitation (MR) repair device, in a patient with severe, symptomatic MR due to annular dilation from atrial functional disease (Carpentier type I). The patient had experienced multiple heart failure events and was unsuitable for surgery due to pulmonary dysfunction and obesity.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 01 Apr 2022; 99:1691-1695

A little leak goes a long way! 5-Year-outcome after transcatheter aortic valve implantation.

Inci E, Block PC
Mild paravalvular leak after TAVR is associated with increased 5-year mortality. Current noninvasive and invasive prediction models for mortality may only hold for short term outcomes. Other imaging modalities aside from transthoracic echocardiography should be strongly considered when assessing paravalvular leak, regardless of severity.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 01 Apr 2022; 99:1590-1591

Transcatheter edge-to-edge repair of the tricuspid valve: The US experience.

Sedhom R, Megaly M, Saad M, Elbadawi A, ... Latib A, Gafoor SA
Objectives
To examine the trends in utilization and outcomes of tricuspid valve (TV) transcatheter edge-to-edge repair (TEER).
Background
Surgery for isolated tricuspid regurgitation is associated with high morbidity and mortality and is rarely performed. TV TEER is an attractive alternative.
Methods
The Nationwide Readmissions Database was queried using the International Classification of Diseases, 10th Revision, procedure code for TV TEER for years 2016-2019. The main outcomes were trends in utilization and in-hospital all-cause mortality.
Results
We identified 918 hospitalizations for TV TEER. There was an uptrend in its utilization from 13 cases in the first quarter of 2016 to 122 cases in the last quarter of 2019 (p trend < 0.001). Concomitant mitral valve (MV) TEER was performed in 42.1% of admissions. The overall in-hospital mortality was 2.1%. Surgical TV replacement was needed in 1.1% of admissions; none of them died during the index hospitalization. Unplanned rehospitalizations were common at 30 days (15.7%); 38.2% of those were due to heart failure. There was no difference in in-hospital mortality between isolated TV TEER and combined MV and TV TEER (1.7% vs. 2.6%, p = 0.359). However, admissions receiving combined procedure had lower length of stay and urgent readmission rate.
Conclusion
The current study showed that there was an increase in the utilization of TV TEER over 2016-2019 in the United States. TV TEER was associated with low rates of in-hospital mortality; however, the rate of urgent readmission remains high, mainly due to heart failure.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 01 Apr 2022; epub ahead of print

A novel \"proximal first\" Inoue balloon catheter for retrograde aortic valvuloplasty: Initial case report.

Onishi T, Fukutomi M, Ando T, Tobaru T
The Inoue balloon, invented for percutaneous transseptal mitral commissurotomy for mitral stenosis, is initially dilated in the distal portion and then the proximal portion, forming an hourglass shape that stabilizes the balloon at the mitral valve orifice with a pulling action. The device has been successfully applied to antegrade aortic valvuloplasty; the hourglass shape stabilizes the balloon across the aortic valve without rapid ventricular pacing. Subsequently, an Inoue balloon was developed for retrograde aortic valvuloplasty using the same design as the antegrade balloon. The hourglass-shaped balloon, however, has difficulty maintaining stability across the aortic valve because the distal portion of the balloon, which inflates first, directly receives systolic pressure from the left ventricle. A novel Inoue balloon was invented to overcome this issue by altering the manner of inflation: the proximal portion inflates first, followed by the distal portion. Theoretically, the proximal portion, which initially inflates just above the aortic valve, remains secure across the valve by applying a pressing force that counteracts the systolic forward pressure. Furthermore, a radiopaque marker is placed at the center of the balloon to enable rapid and precise balloon adjustment. We present a case involving a 65-year-old female hemodialysis patient with severe symptomatic aortic stenosis who we successfully treated with balloon aortic valvuloplasty using the novel Inoue balloon followed by transcatheter aortic valve implantation. The present case demonstrates the feasibility and effectiveness of the novel \"proximal first\" Inoue balloon for retrograde balloon aortic valvuloplasty for severe aortic stenosis.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Mar 2022; epub ahead of print

International percutaneous coronary intervention complication survey.

Simsek B, Kostantinis S, Karacsonyi J, Hall A, ... Sandoval Y, Brilakis ES
Objectives
To investigate the perceptions of interventional cardiologists (IC) regarding the frequency, impact, and management strategies of percutaneous coronary intervention (PCI) complications.
Background
The perceptions and management strategies of ICs of PCI complications have received limited study.
Methods
Online survey on PCI complications: 46 questions were distributed via email lists and Twitter to ICs.
Results
Of 11,663 contacts, 821 responded (7% response rate): 60% were from the United States and the median age was 46-50 years. Annual PCI case numbers were <100 (26%), 100-199 (37%), 200-299 (21%), and ≥300 (16%); 42% do not perform structural interventions, others reported performing <40 (30%), or >100 (11%) structural cases annually. On a scale of 0-10, participating ICs were highly concerned about potential complications with a median score of 7.2 (interquartile range: 5.0-8.7). The most feared complication was death (39%), followed by coronary perforation (26%) and stroke (9%). Covered stents were never deployed by 21%, and 32% deployed at least one during the past year; 79% have never used fat to seal perforations; 64% have never used coils for perforations. Complications were attributed to higher patient/angiographic complexity by 68% and seen as opportunities for improvement by 70%; 97% of participants were interested in learning more about the management of PCI complications. The most useful learning methods were meetings (66%), webinars (48%), YouTube (32%), and Twitter (29%).
Conclusion
ICs who participated in the survey are highly concerned about complications. Following complication management algorithms and having access to more experienced operators might alleviate stress and optimize patient outcomes.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Mar 2022; epub ahead of print

Completion peripheral angiography in single-access, Impella-assisted, high-risk PCI: Using a buddy microcatheter sheath after MANTA closure for imaging and potential bailout.

Summers MR, Lavigne PM, Mahoney PD
High-risk percutaneous coronary intervention (HR-PCI) is increasingly performed, often with mechanical circulatory support (MCS) provided by devices like the Impella CP. Bleeding and vascular complications remain concerns for HR-PCI, leading to significantly higher in-hospital mortality, duration of stay, and cost, which are important considerations in the decisions surrounding MCS support for HR-PCI. Newly introduced, single-catheter techniques for Impella-supported HR-PCI, along with recent approvals of dedicated large-bore closure devices (MANTA®-Vascular Closure Device) may reduce bleeding and vascular complications, but have limitations with regard to completion of peripheral angiography and/or postclosure percutaneous bailout options. The present technique offers a potential solution to these limitations, and describes a buddy microcatheter approach to postclosure management of HR-PCI with MCS, which was highly successful in a consecutive series of patients at our institution.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Mar 2022; epub ahead of print

Mitral valve-in-valve and valve-in-ring procedures: Midterm outcomes in a French nationwide registry.

Le Ruz R, Guérin P, Leurent G, Leroux L, ... Iung B, Manigold T
Objectives
Report contemporary outcomes in patients included in the Mitragister registry and treated with transcatheter mitral valve implantation for failed surgical annuloplasty rings or deteriorated bioprosthesis.
Background
Midterm survival rates have been reported, but little is known about contemporary morbimortality endpoints.
Methods
The primary safety outcome was the technical success rate. The primary efficacy composite endpoint was a composite of cardiovascular mortality and heart failure hospitalizations.
Results
From 2016 to 2021, 102 patients (median age: 81 [74;84] years, 61% female, Euroscore II 11.0% [7.8;16.0]) undergoing valve-in-valve (ViV; n = 89) or valve-in-ring (ViR; n = 13) procedures were consecutively included. At baseline, ViR group patients had worse left ventricular ejection fraction (50% vs. 60%; p = 0.004) and more frequently severe regurgitation (46% vs. 15%; p = 0.014). The primary safety outcome was 95%: 77% and 98% in the ViR and ViV populations, respectively, (p = 0.014). At intermediate follow-up (6-12 months) clinical improvement was notable, 88% of the patients were in NYHA class ≤ II (vs. 25% at baseline; p < 0.001). At a mean follow-up of 17.1 ± 11.0 months, the primary efficacy composite reached 27%. By multivariate analysis, paravalvular leak (PVL) was the only independent predictor (hazard ratio: 2.39, 95% confidence interval: 1.08-5.29; p = 0.031) while ViR was not found statistically associated (p = 0.456).
Conclusions
This study confirms the safety and efficacy of the mitral ViV procedure. ViR patients appear at higher risk of procedural complications. The presence of PVL could be associated with markedly worse midterm prognosis. Whatever the intervention, procedural strategies to reduce PVL incidence remain to be assessed to prevent latter adverse outcomes.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 24 Mar 2022; epub ahead of print

Validation of a novel staging classification system based on the extent of cardiac damage among Chinese patients after transcatheter aortic valve replacement: A single-center retrospective study.

Zhu Q, Yuan Z, Xu Y, Chen J, ... Liu X, Wang J
Objectives
We aimed to validate a novel staging system for aortic stenosis (AS) in a Chinese patient cohort undergoing transcatheter aortic valve replacement (TAVR), and to compare this classification system to the traditional Society of Thoracic Surgeons (STS) score for TAVR risk stratification.
Background
A novel staging system for AS based on the extent of cardiac damage upon echocardiography was recently proposed.
Methods
Patients were prospectively enrolled into the Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population and analyzed retrospectively following additional exclusion criteria. On the basis of echocardiographic findings of cardiac damage, patients were classified into five stages (0-4).
Results
A total of 427 patients were included in the current analysis. Forty-eight deaths occurred during a median follow-up of 730 days following TAVR. The staging system showed a statistically significant association between cardiac damage and all-cause mortality; advanced stages were associated with higher mortality. In a multivariate-adjusted Cox proportional hazards regression model, stage and STS scores served as risk factors for 2-year mortality. Each increment in the staging class was associated with an increased risk of mortality (hazard ratio, 1.275; 95% confidence interval [CI], 1.052-1.545). Receiver operating characteristic (ROC) curves were plotted for stage (area under the curve, 0.644; 95% CI, 0.562-0.725) and STS score (0.661; 0.573-0.749), and with no statistically significant differences between ROC curves (p = 0.920).
Conclusions
We validated a novel staging system as a key risk factor for 2-year mortality in a Chinese TAVR patient cohort. Efficacy for risk stratification was comparable to the STS score.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 24 Mar 2022; epub ahead of print

Annual operator volume among patients treated using percutaneous coronary interventions with rotational atherectomy and procedural outcomes: Analysis based on a large national registry.

Januszek R, Siudak Z, Malinowski KP, Wańha W, ... Legutko J, Bartuś S
Background
Low operator and institutional volume are associated with poorer procedural and long-term clinical outcomes in the general population of patients treated with percutaneous coronary interventions (PCI).
Aim
To assess the relationship between operator experience and procedural outcomes of patients treated with PCI and rotational atherectomy (RA).
Methods
Data for conducting the current analysis were obtained from the national registry of percutaneous coronary interventions (ORPKI) maintained in cooperation with the Association of Cardiovascular Interventions (AISN) of the Polish Cardiac Society. The study covers data from January 2014 to December 2020.
Results
During the investigated period, there were 162 active CathLabs, at which 747,033 PCI procedures were performed by 851 operators (377 RA operators [44.3%]). Of those, 5188 were PCI with RA procedures; average 30 ± 61 per site/7 years (Me: 3; Q1-Q3: 0-31); 6 ± 18 per operator/7 years (Me: 0; Q1-Q3: 0-3). Considering the number of RA procedures annually performed by individual operators during the analyzed 7 years, the first quartile totaled (Q1: < =2.57), the second (Q2: < =5.57), and the third (Q3: < =11.57), while the fourth quartile was (Q4: > 11.57). The maximum number of procedures was 39.86 annually per operator. We demonstrated, through a nonlinear relationship with annualized operator volume and risk-adjusted, that operators performing more PCI with RA per year (fourth quartile) have a lower number of the overall periprocedural complications (p = 0.019).
Conclusions
High-volume RA operators are related to lower overall periprocedural complication occurrence in patients treated with RA in comparison to low-volume operators.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 22 Mar 2022; epub ahead of print

Device entrapment during percutaneous coronary intervention.

Sanz-Sánchez J, Mashayekhi K, Agostoni P, Egred M, ... Brilakis ES, Gasparini GL
Introduction
Device entrapment is a life-threatening complication during percutaneous coronary intervention (PCI). However, the success for its management is predominantly based on operator experience with limited available guidance in the published literature.
Methods
A systematic review was performed on December 2021; we searched PubMed for articles on device entrapment during PCI. In addition, backward snowballing (i.e., review of references from identified articles and pertinent reviews) was employed.
Results
A total of 4209 articles were retrieved, of which 150 studies were included in the synthesis of the data. A methodical algorithmic approach to prevention and management of device entrapment can help to optimize outcomes. The recommended sequence of steps are as follows: (a) pulling, (b) trapping, (c) snaring, (d) plaque modification, (e) telescoping, and (f) surgery.
Conclusions
In-depth knowledge of the techniques and necessary tools can help optimize the likelihood of successful equipment retrieval and minimization of complications.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 21 Mar 2022; epub ahead of print

Volume of contrast to creatinine clearance ratio predicts early mortality and AKI after TAVI.

Venturi G, Scarsini R, Pighi M, Kotronias RA, ... Banning A, Ribichini F
The volume of contrast to creatinine clearance ratio (CV/CrCl) is a useful indicator of the risk of acute kidney injury (AKI) in patients undergoing percutaneous interventional procedures. Association between CV/CrCl and adverse outcome after transcatheter aortic valve implantation (TAVI) was suggested but it is not well established. A large retrospective multicenter cohort of 1381 patients treated with TAVI was analyzed to assess the association between CV/CrCl and the risk of AKI and mortality at 90 days and 1 year after TAVI. Patients receiving renal replacement therapy at the time of TAVI were excluded. CV/CrCl ≥ 2.2 was associated with the risk of AKI and 90 days mortality after TAVI after adjustment for age, sex, diabetes, baseline left ventricular function, baseline chronic kidney disease (CKD), previous myocardial infarction and peripheral vascular disease (hazard ratio [HR]: 1.16, 95% confidence interval [CI]: 1.09-1.22, p < 0.0001). Importantly, CV/CrCl was associated with the adverse outcome independently from the presence of baseline CKD (p for interaction = 0.22). CV/CrCl was independently associated with the individual components of the composite primary outcome including AKI (odds ratio: 1.18, 95% CI: 1.08-1.28, p < 0.0001) and 90 days mortality (HR: 1.90, 95% CI: 1.01-3.60, p = 0.047) after TAVI. AKI (HR: 1.94, 95% CI: 1.21-3.11, p = 0.006) but not CV/CrCl was associated with the risk of 1-year mortality after TAVI. CV/CrCl is associated with excess renal damage and early mortality after TAVI. Procedural strategies to minimize the CV/CrCl during TAVI may improve early clinical outcomes in patients undergoing TAVI.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 21 Mar 2022; epub ahead of print

Coronary orbital atherectomy treatment of Hispanic and Latino patients: A real-world comparative analysis.

Beohar N, Stone GW, Martinsen BJ, Parise H, ... Leon MB, Kirtane AJ
Objectives
To assess coronary orbital atherectomy (OA) use in Hispanic or Latino (HL) patients compared to non-HL patients.
Background
HL patients are at greater risk of cardiovascular disease mortality compared with Whites with similar coronary artery calcium (CAC) scores. The safety and efficacy of coronary atherectomy in the HL patient population is unknown due to the under-representation of minorities in clinical trial research.
Methods
A retrospective analysis of consecutive patients undergoing coronary OA treatment of severely calcified lesions at the Mount Sinai Medical Center, Miami Beach, Florida (MSMCMB) was completed. From January 2014 to September 2020, a total of 609 patients from MSMCMB who underwent percutaneous coronary intervention with OA were identified in the electronic health records.
Results
Of those identified, 350 (57.5%) had an ethnicity classification of HL. The overall mean age was 74 years and there was a high prevalence of diabetes in the HL group compared to the non-HL group (49.7% vs. 34.7%; p = 0.0003). Severe angiographic complications were uncommon and in-hospital freedom from major adverse cardiac events (MACE), a composite of cardiac death, MI, and stroke (ischemic or hemorrhagic cerebrovascular accidents), was 98.5% overall, with no significant difference between the HL and non-HL groups, despite the higher prevalence of diabetes in the HL group.
Conclusions
This study represents the largest real-world experience of OA use in HL versus non-HL patients. The main finding in this retrospective analysis is that OA can be performed safely and effectively in a high-risk population of HL patients.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 21 Mar 2022; epub ahead of print

Early and late outcomes of surgical aortic valve replacement with sutureless and rapid-deployment valves versus transcatheter aortic valve implantation: Meta-analysis with reconstructed time-to-event data of matched studies.

Sá MP, Jabagi H, Dokollari A, Awad AK, ... Weymann A, Ramlawi B
Sutureless/rapid-deployment (SURD) valves are options different from the stented prostheses included in the pivotal trials comparing surgical aortic valve replacement (AVR) and transcatheter aortic valve implantation (TAVI). We performed a meta-analysis with reconstructed time-to-event data of matched studies published by November 2021 to compare SURD-AVR and TAVI. Primary endpoints were 30-day mortality and overall survival in the follow-up. Secondary endpoints included: 30-day stroke, acute kidney injury (AKI), major bleeding, permanent pacemaker implantation (PPI), paravalvular leak (PVL), prosthesis-patient mismatch (PPM), postoperative aortic valve area (AVA), and mean gradients. Ten studies met our eligibility criteria, including a total of 5134 patients (2567 underwent SURD-AVR and 2567 underwent TAVI). Pooled risk of 30-day mortality did not favor any group (odds ratio [OR]: 0.69; 95% confidence interval [CI]: 0.31-1.53; p = 0.360). Patients undergoing SURD-AVR had lower risk of PVL (OR: 0.09; 95% CI: 0.05-0.17; p < 0.001). No statistically significant differences were observed for 30-day stroke, AKI, major bleeding, PPI, PPM, and postoperative AVA. In the follow-up, we observed a higher risk of mortality (hazard ratio: 1.74; 95% CI: 1.26-2.40; p < 0.001) with TAVI. Patients who underwent SURD-AVR experienced better survival, however, the interpretation of these results warrant caution due to the fact that SURD-AVR patients tended to be younger than TAVI patients. Structural heart surgeons and interventional cardiologists should consider initial risk and life expectancy when referring patients for one approach over the other.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 21 Mar 2022; epub ahead of print

Outcomes and feasibility of redo-TAVR after Sapien 3 Ultra TAVR in extremely-undersized versus nominally-sized annuli.

Tang GHL, Hooda A, Zaid S, Chuang MY, ... Webb JG, Sathananthan J
Objectives
To compare outcomes in Sapien 3 Ultra (S3U) transcatheter aortic valve replacement (TAVR) with extreme annular undersizing (EAU) versus nominal annular sizing (NAS).
Background
The Edwards S3U valve has reduced paravalvular leak (PVL) in TAVR but outcomes remain unknown in extremely undersized anatomy. Implanting a smaller S3U valve may facilitate future redo-TAVR but risk compromising hemodynamics.
Methods
From December 2019 to July 2021, 366 patients with native aortic stenosis underwent S3U TAVR. Patients with EAU (annular areas >430 mm² for 23 mm or >546 mm² for 26 mm) were compared to NAS (338-430 mm² for 23 mm or 430-546 mm² for 26 mm). In-hospital and 30-day outcomes, and redo-TAVR feasibility were determined.
Results
There were 79 (21.6%) EAU patients, with more bicuspid (p = 0.0014) and ≥moderate annular/left ventricular outflow tract calcification (p < 0.001). The EAU group had less annular oversizing than NAS group (23 mm: -8.2 ± 2.6% vs. 4.0 ± 7.0%, p < 0.001; 26 mm: -8.9 ± 2.2% vs. 6.7 ± 6.9%, p < 0.001), more balloon overfilling (71.3% vs. 11.6%, p < 0.001), and postdilatation (15.0% vs. 5.8%, p = 0.016). No differences were found in in-hospital or 30-day mortality and stroke (p > 0.05). Mild PVL (13.4% EAU vs. 11.5% NAS, p = 0.56) and mean gradients (23 mm: 13.0 ± 4.5 vs. 14.1 ± 5.4 mmHg, p = 0.40; 26 mm: 11.4 ± 4.1 vs. 11.5 ± 3.9 mmHg, p = 1.0) were similar at 30 days. Had the EAU group undergone NAS with the larger Sapien 3/S3U, by computed tomography analysis simulating 80:20 or 90:10 target implant depth, 33.3%-60.9% (vs. 4.3%-23.2%) would not be feasible for redo-TAVR due to high risk of coronary obstruction.
Conclusions
In this first report of EAU with S3U TAVR, similar excellent short-term outcomes can be achieved compared to NAS, and may preserve future redo-TAVR option.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 21 Mar 2022; epub ahead of print

Stroke after transcatheter aortic valve replacement: A severe complication with low predictability.

Eschenbach LK, Erlebach M, Deutsch MA, Ruge H, ... Lange R, Burri M
Objectives
We aimed to describe stroke and transient ischemic attacks (TIAs) after transcatheter aortic valve replacement (TAVR) and to identify associated risk factors.
Background
Stroke/TIA after TAVR is a major complication.
Methods
A total of 1919 concomitant patients underwent TAVR in a single center from 2007 to 2017. Pre-, intra-, and postprocedural data were collected prospectively in a database and analyzed retrospectively. Stroke and TIA were documented according to the Valve Academic Research Consortium-II criteria. Logistic regression was used to determine risk factors for stroke after TAVR.
Results
Mean age was 79.5 ± 6.8 years, mean logistic EuroScore was 17.6% ± 12.8%, and 51.8% (n = 994) of the patients were female. Stroke/TIA occurred in 76 patients (3.9%), 1.9% were disabling, and 1.6% nondisabling. The predominant type of stroke were territorial ischemic lesions (82.4%), with primary bleeding in 4.4% and border zone infarctions in 4.4%. Left-sided lesions were more common (45.6% left sided vs. 25% right sided) and 13.2% of the lesions were bilateral (4.4% no finding and 11.8% missing data). In multivariate logistic regression, prior stroke (odds ratio [OR] = 1.83, p = 0.046) and initial experience (first 300 TAVR implanted at our center) were identified as independent risk factors for stroke/TIA during the first 30 days (OR = 1.95, p = 0.045). Overall, the occurrence of stroke had a highly significant impact on a 30-day mortality (13.2% vs. 4.9% in patients without stroke (p = 0.005).
Conclusion
Stroke within the first 30 days after TAVR severely impairs 30-day survival. We identified prior stroke and initial experience as significant independent risk factors for the occurrence of stroke after TAVR.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 21 Mar 2022; epub ahead of print

Mitral valve edge-to-edge repair versus indirect mitral valve annuloplasty in atrial functional mitral regurgitation.

Rottländer D, Golabkesh M, Degen H, Ögütcü A, Saal M, Haude M
Objectives
We aimed to compare indirect mitral annuloplasty using the Carillon Mitral Contour System and edge-to-edge repair via MitraClip in atrial functional mitral regurgitation (aFMR).
Background
In patients with left ventricular dilation, both edge-to-edge repair and indirect mitral annuloplasty are effective in reducing mitral regurgitation, while no clinical trial has compared both interventional methods in aFMR.
Methods
In a retrospective single-center analysis, 41 patients with aFMR underwent either edge-to-edge mitral valve repair (MitraClip group, n = 20) or indirect annuloplasty (Carillon group, n = 21).
Results
Both treatment groups showed high procedural success (100%) and low complication rates. Both treatment groups showed a comparable reduction of New York Heart Association (NYHA) classification postimplantation, after 3- and 12-months follow-up. Quantitative reduction in echocardiographic FMR parameters was significantly pronounced in the MitraClip group (reduction in vena contracta MitraClip vs. Carillon: postimplantation -74.6 ± 25.8 vs. -29.1 ± 17.8%, 3-months follow-up -65.8 ± 31.2 vs. -33.9 ± 17.5%, 12-months follow-up -50.8 ± 27.9 vs. -23.9 ± 17.0%, p < 0.05). Qualitative mitral valve assessment showed improved FMR class postimplantation, at 3-and 12-months follow-up in both treatment groups. Edge-to-edge repair revealed better results with lower average FMR classification compared to indirect coronary sinus-based annuloplasty. After 12-months left atrial (LA) volume was significantly reduced in the Carillon group, while in the MitraClip group no LA remodeling was found (reduction in LA volume MitraClip vs. Carillon at 12 months: +9.6 ± 25.1% vs. -12.3 ± 12.7%, p < 0.05).
Conclusions
Both indirect mitral valve annuloplasty and edge-to-edge repair are feasible and safe in patients with aFMR, while the reduction in FMR was pronounced in the edge-to-edge repair group.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 21 Mar 2022; epub ahead of print

Effect of prehospital treatment in STEMI patients undergoing primary PCI.

Fabris E, Menzio S, Gregorio C, Pezzato A, ... Van\'t Hof AW, Sinagra G
Background
The appropriate timing to administer antithrombotic therapies in ST-elevation myocardial infarction (STEMI) remains uncertain. This study aims to evaluate the role of antithrombotic therapy administration at first medical contact (FMC) compared with the administration in the Cathlab.
Methods
We conducted a \"before-after\" observational study enrolling STEMI undergoing primary percutaneous coronary intervention (PCI). Outcomes were evaluated during two successive periods, before (control group: aspirin only at FMC) and after (pretreated intervention group: heparin, aspirin plus ticagrelor at FMC) the introduction of a new regional pretreatment protocol.
Results
A total of 537 consecutive patients (300 in control vs. 237 in intervention group) were enrolled. The pretreated compared with no pretreated population showed better basal reperfusion, expressed as basal Thrombolysis in Myocardial Infarction (TIMI)-flow (p for trend p < 0.001). Pretreated population showed lower frequency of TIMI 0 (56.5% vs. 73.7%, odds ratio [OR]: 0.46, 95% confidence interval [CI]: 0.32-0.67, p < 0.001) and higher frequency of TIMI 2-3 (33.3% vs. 19.3% OR: 2.0, 95% CI: 1.38-2.00, p < 0.001) and TIMI 3 (14.3% vs. 9.7%, OR: 1.56, 95% CI: (0.92-2.65), p = 0.094). Pretreated compared with no pretreated population showed reduced infarct size expressed as Troponin Peak (20,286 (8726-75,027) versus 48,676 (17,229-113,900), p = 0.001), and higher left ventricular ejection fraction at discharge (53% (44-59) vs. 50% (44-56), p = 0.027). In-hospital BARC ≥ 2 bleeding were similar (2.1% vs. 2.0%, p = 0.929, in pretreated versus no pretreated population, respectively).
Conclusion
This study provides support for an early pretreatment strategy in STEMI patients and confirmed the importance of an efficient organization of STEMI networks which allow initiation of antithrombotic treatment at FMC.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Mar 2022; epub ahead of print

Characteristics and clinical outcomes in patients with prior chest radiation undergoing TAVR: Observations from PARTNER-2.

Mohanty BD, Coylewright M, Sequeira AR, Shin D, ... Leon MB, Malenka D
Objectives
The purpose of this study is to investigate the viability of transcatheter aortic valve replacement (TAVR) for severe symptomatic aortic stenosis (AS) in patients with prior chest radiation therapy (cXRT).
Background
Since patients with prior cXRT perform poorly with surgical aortic valve replacement, TAVR can be a viable alternative. However, clinical outcomes after TAVR in this patient population have not been well studied.
Methods
From the pooled registry of the placement of aortic transcatheter valves II trial, we identified patients with and without prior cXRT who underwent TAVR (n = 64 and 3923, respectively). The primary outcome was a composite of all-cause death and any stroke at 2 years. Time to event analyses were shown as Kaplan-Meier event rates and compared by log-rank testing. Hazard ratios (HRs) were estimated and compared by Cox proportional hazards regression model.
Results
There was no significant difference in the primary outcome between the patients with and without prior cXRT (30.7% vs. 27.0%; p = 0.75; HR, 1.08; 95% confidence interval, 0.66-1.77). Rates of myocardial infarction, vascular complications, acute kidney injury, or new pacemaker implant after TAVR were not statistically different between the two groups. The rate of immediate reintervention with a second valve for aortic regurgitation after TAVR was higher among the patients with prior cXRT. However, no further difference was observed during 2 years follow-up after discharge from the index-procedure hospitalization.
Conclusions
TAVR is a viable alternative for severe symptomatic AS in patients who had cXRT in the past.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Mar 2022; epub ahead of print

Supravalvular pulmonary stenosis: A risk factor for reintervention in Noonan syndrome with pulmonary valve stenosis.

Abumehdi M, Mehta C, Afifi ARSA, Yong SF, ... Dhillon R, Stumper O
To assess the short- and long-term outcomes of balloon pulmonary valvuloplasty (BPV) in children with Noonan syndrome (NS). Pulmonary stenosis (PS) is the most common congenital heart lesion in NS. BPV is the accepted first line treatment in PS. However, BPV in NS patients has been reported to be less effective, without specific factors for the need for reintervention being identified. Retrospective case-note review of all patients with NS who underwent BPV between 1985 and 2020. Patients were divided into 2 groups: those with supravalvular pulmonary stenosis (SPS) in addition to valvar PS, and those with isolated valvar PS. A cohort of 54 patients with NS underwent BPV at a median of 275 (interquartile range [IQR]: 108-575) days of age. SPS was present in 32 (59%) patients whereas 22 had (41) isolated PS. The preprocedural invasive gradient was 47 (IQR: 35-69) mmHg, and 44 (IQR: 35-48) mmHg in those with SPS and those without respectively (p = 0.88). Reintervention was required in 22 patients (41%): 17 (77%) -with SPS and 5 (23%) without (p = 0.017). Fourteen patients (11 with SPS) required surgical reintervention and 8 (6 with SPS) required further BPV. There was no significant difference in the age at initial BPV, pre- and postprocedural gradients and interval until reintervention between groups. This is the largest reported cohort of patients with NS undergoing BPV. Although BPV is often successful, the reintervention rates are high. SPS was a risk factor for reintervention.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Mar 2022; epub ahead of print

Rates and impact of vascular complications in mechanical circulatory support.

Lemor A, Dabbagh MF, Cohen D, Villablanca P, ... O\'Neill W, Basir MB
Background
Mechanical circulatory support (MCS) devices are increasingly used for hemodynamic support in cardiogenic shock or high-risk percutaneous coronary interventions. Vascular complications remain a major source of morbidity and mortality despite technological advances with percutaneous techniques. Little is known about the rates and predictors of vascular complications with large-bore access MCS in the contemporary era.
Methods
The study cohort was derived from National Inpatient Sample using data from 2015 to 2019 for cardiac hospitalizations with the use of: intra-aortic balloon pump (IABP) Impella, and/or extracorporeal membrane oxygenation (ECMO). The rates of vascular complications and in-hospital outcomes were analyzed using multivariable logistic regression.
Results
Of 221,700 hospitalizations with MCS use, the majority had only IABP (68%). The rates of vascular complications were greatest with ECMO (15.8%) when compared with IABP (3.0%) and Impella (5.6%). Among patients with vascular complications, in-hospital mortality was higher with ECMO (56.3%) when compared with IABP (26.2%) and Impella (33.8%). Peripheral arterial disease (PAD) was the strongest predictor of vascular complications, with 10 times higher odds when present (adjusted odds ratio [aOR] 10.96, p < 0.001). In risk-adjusted models, when compared with IABP, the use of Impella (aOR: 1.73, p < 0.001), ECMO (aOR: 5.35, p < 0.001), or a combination of MCS devices (aOR: 3.47, p < 0.001) was associated with higher odds of vascular complications.
Conclusions
In contemporary practice, the use of MCS is associated with significant vascular complications and in-hospital mortality. Predictors of vascular complications include larger arteriotomy size, female gender, and peripheral arterial disease. Vascular access management remains essential to prevent major complications.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Mar 2022; epub ahead of print

The Gore Cardioform Atrial Septal Defect Occluder: A novel solution to the management of severe hemolysis following transcatheter septal defect closure.

Naimi I, Jones TK, Steinberg Z
Significant hemolysis is a recognized complication of transcatheter high-velocity shunt occlusion using some Amplatzer devices. We describe a case of severe hemolysis following occlusion of an iatrogenic Gerbode defect with an Amplatzer muscular ventricular septal defect occluder successfully managed by transcatheter device removal and reocclusion with a Gore Cardioform Atrial Septal Defect Occluder.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 07 Mar 2022; epub ahead of print

Impact of severity of baseline thrombocytopenia on outcomes after percutaneous coronary interventions: Analysis from the Veterans Affairs Clinical Assessment, Reporting, and Tracking (VA CART) Program.

Vallurupalli S, Hess E, Plomondon ME, Park K, ... Agarwal S, Uretsky BF
Objectives
The aim of this study was to evaluate the effect of the degree of severity of baseline thrombocytopenia (TCP) on outcomes after percutaneous coronary intervention (PCI) BACKGROUND: The association of TCP with clinical outcomes among patients undergoing coronary intervention has not been previously evaluated.
Methods
Using data from the US Veterans Affairs Clinical Assessment, Reporting, and Tracking (CART) Program, we identified patients undergoing PCI between October 1, 2007, to September 30, 2017. The cohort was then stratified by platelet count, as no TCP (platelet count >150,000/mcl), mild TCP (100-150,000/mcl), or moderate-severe TCP (<100,000/mcl) and this was associated with clinical outcomes.
Results
The cohort included 80,427 patients (98% male), of which 14.9% (13.2% mild, 1.7% moderate-severe) suffered from TCP at the time of PCI. Compared with mild or no TCP, moderate-severe TCP was associated with increased risk of post-PCI pericardiocentesis (0.6% vs. 0.2% vs. 0.2%, p = 0.018) and in-hospital mortality (1.5% vs. 0.7% vs. 0.7%) without a difference in postprocedure stroke (0.5% vs. 0.3% vs. 0.3%, p = 0.6). Over a median follow-up of 1729 days, time-to-repeat revascularization was significantly shorter in moderate-severe TCP (1080 vs. 1347 vs. 1467 days, p < 0.001) despite lower risk of revascularization. Both mild (adjusted HR: 1.11, 95% CI: 1.07-1.15, p < 0.001) and moderate-severe TCP (HR: 1.55, 95% CI: 1.43-1.69, p < 0.001) were associated with increased all-cause mortality compared with those without TCP.
Conclusions
Thrombocytopenia was associated with increased short- and long-term adverse events among patients undergoing PCI. Any degree of TCP was associated with increased long-term all-cause mortality while moderate-severe TCP was also associated with increased risk of periprocedural adverse events.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 06 Mar 2022; epub ahead of print

Individual patient data meta-analysis of patients treated with a heparin-bonded Viabahn in the femoropopliteal artery for chronic limb-threatening ischemia.

Groot Jebbink E, van Wijck I, Holewijn S, Iida O, ... Bosiers M, Reijnen MMPJ
Objectives
The aim of the study was to analyze available data on patients treated for chronic limb-threatening ischemia (CLTI) with the heparin-bonded Viabahn endoprosthesis.
Background
The patency of self-expanding covered stents in patients with complex femoropopliteal lesions is encouraging. However, data were mostly derived in patients with intermittent claudication. Patients with CLTI often have more advanced disease and worse outcome.
Methods
After the abstract screening, full-text papers were checked. Authors were approached to consider joining the consortium. Data were sent anonymously, databases were merged and an individual patient data meta-analysis was performed. Kaplan-Meier curves were used to calculate the freedom from amputations, the amputation-free survival, and patency rates.
Results
Seven studies were enrolled, representing 161 limbs that were treated for CLTI. Median lesion length was 28.0 cm (interquartile range 25.0-33.0 cm) and 82.7% were chronic total occlusions. The technical success rate was 98.1% and the 30-day mortality 1.9%. Through 2-year follow-up, the freedom-from-major-amputations was 99.3%, with an amputation-free survival of 78.8%. The freedom-from-loss-of primary, primary-assisted, and secondary patency was 70.4%, 71.8%, and 88.2%, respectively, at 1-year and 59.5%, 62.7%, and 86.1% at 2-year follow-up, respectively. The reintervention-free survival was 62.2% at a 2-year follow-up.
Conclusions
Treatment of femoropopliteal disease in CLTI patients with the use of the heparin-bonded Viabahn is safe and effective with favorable clinical outcomes and low amputation rates. Reinterventions are needed in a subset of the population to maintain endoprosthesis patency. Close follow-up using duplex is recommended to detect potential edge stenosis, allowing treatment before device occlusion.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 06 Mar 2022; epub ahead of print

Laser vaporization of atherothrombotic burden before drug-coated balloon application in ST-segment elevation myocardial infarction: Two-year outcomes of the laser-DCB trial.

Tonomura D, Shimada Y, Yamanaka Y, Terashita K, ... Tsuchida T, Fukumoto H
Objectives
This study aimed to examine whether the combination of excimer laser coronary atherectomy (ELCA) and drug-coated balloon (DCB) angioplasty can provide feasible clinical outcome in patients with ST-segment elevation myocardial infarction (STEMI) with 8-month and 2-year scheduled follow-up angiography.
Background
Intracoronary thrombus elevates the risk of interventional treatment in patients with STEMI and hampers drug absorption into the vasculature released from DCB.
Methods
Sixty-two patients with STEMI within 24 h after the onset of symptoms were enrolled in this prospective, single-center, single-arm study.
Results
The laser catheter was successfully crossed distal to the culprit lesion in all cases. No ELCA-related adverse events occurred. Bail-out stenting was required in two patients (3.2%) after adjunctive ballooning; thus, the remaining 60 patients were completed with DCB angioplasty without stenting. Scheduled angiography at 8 months and 2 years was completed in 100% and 85.2%, respectively, and minimal lumen diameters were 3.4 ± 0.5, 3.4 ± 0.6, and 3.4 ± 0.5 mm after the procedure, at 8 months and at 2 years, respectively. Binary restenosis was observed in five patients (8.1%) in whom target lesion revascularization was performed. The duration of dual antiplatelet therapy was 2.3 ± 2.2 months, and neither abrupt vessel closure, reinfarction, cardiac death nor major bleeding was observed.
Conclusion
A combination of DCB angioplasty with ELCA is a feasible therapeutic option for STEMI.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 06 Mar 2022; epub ahead of print

The double injection technique to improve visualization of severe coronary lesions with optical coherence tomography.

Rivero F, Marco V, Biccirè FG, Budassi S, ... Prati F, Alfonso F
Background
Optical coherence tomography (OCT) is a high-resolution imaging modality that provides a precise evaluation of coronary anatomy. However, the presence of severe coronary lesions can prevent the required adequate distal contrast flushing resultting in inadequate blood clearance and poor image quality or complete blood shadowing of the underlying vessel wall.
Objectives
The aim of this prospective study was to evaluate the feasibility and safety of a novel \"double injection technique\" (DIT) to overcome the limitations of the conventional technique (CT) in patients with severely stenotic lesions.
Methods
Twenty-three patients with severe angiographic lesions were sequentially imaged before intervention with OCT with the CT and then with DIT. A total of 5125 OCT frames were carefully matched and analyzed by an independent central core lab. A semiquantitative image quality score was used to grade the number of quadrants (0-4) with vessel wall visualization.
Results
Optimal OCT visualization (Grades 3-4) significantly improved by the DIT (68% vs. 38% of frames, p < 0.001). The DIT also improved the mean score (3.1 ± 0.6 vs. 2.0 ± 0.8; p < 0.05; mean improvement of 1.1 ± 0.5 per patient). There were no complications associated with the DIT.
Conclusion
The DIT significantly improved preintervention image quality of OCT in severe coronary lesions.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Mar 2022; epub ahead of print

Not all pseudoaneurysms are femoral-A transcaval transcatheter aortic valve replacement rare complication.

Mano TB, Ramos R, Cacela D, Patrício L
We report a case of a 73-year-old male with multiple comorbidities, including postpoliomyelitis severe scoliosis, referred to our tertiary center due to a severe symptomatic aortic stenosis, considered high risk for surgical aortic valve replacement (AVR). Due to unsuitable femoral and subclavian accesses, the patient underwent a transcaval transcatheter AVR (TAVR) procedure, complicated by the development of an iatrogenic infrarenal aortic pseudoaneurysm with aortocaval fistula. Scoliosis can cause varying anatomic relationships between retroperitoneal vessels and intervertebral disk spaces, which increase the difficulty of the procedure and consequently lead to this vascular complication. Although most aortocaval fistulas close spontaneously after 1 year, the risk of pseudoaneurysm rupture in this critical area was crucial in the decision of a new successful percutaneous aortic stent intervention.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Mar 2022; epub ahead of print

Development, validation, and reproducibility of the pullback pressure gradient (PPG) derived from manual fractional flow reserve pullbacks.

Sonck J, Mizukami T, Johnson NP, Nagumo S, ... De Bruyne B, Collet C
Fractional flow reserve (FFR) pullbacks assess the location and magnitude of pressure drops along the coronary artery. The pullback pressure gradient (PPG) quantifies the FFR pullback curve and provides a numeric expression of focal versus diffuse coronary artery disease. This study aims (1) to validate the PPG using manual FFR pullbacks compared with motorized FFR pullbacks as a reference; and (2) to determine the intra- and interoperator reproducibility of the PPG derived from manual FFR pullbacks. Patients with stable coronary artery disease and an FFR ≤ 0.80 were included. All patients underwent FFR pullback evaluation either with a motorized device or manually, depending on the study cohort. The agreement of the PPG between repeated pullbacks was assessed using the Bland-Altman method. Overall, 116 FFR pullback maneuvers (96 manual and 20 motorized) were analyzed. There was excellent agreement between the PPG derived from manual and motorized pullbacks (mean difference -0.01 ± 0.07, 95% limits of agreement [LOA] -0.14 to 0.12). The intra- and interoperator reproducibility of PPG derived from manual pullbacks were excellent (mean difference <0.01, 95% LOA -0.11 to 0.12, and mean difference <0.01, 95% LOA -0.12 to 0.11, respectively). The duration of the pullback maneuver did not impact the reproducibility of the PPG (r = 0.12, 95% CI: -0.29 to 0.49, p = 0.567). Manual pullbacks allow for an accurate PPG calculation. The inter- and intraoperator reproducibility of PPG derived from manual pullbacks were excellent.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 01 Mar 2022; epub ahead of print

Leak closure following left atrial appendage exclusion procedures: A multicenter registry.

Killu AM, Gbolabo Adeola O, Della Rocca DG, Ellis C, ... Alkhouli M, Holmes DR
Background
Though infrequent, incomplete left atrial appendage closure (LAAC) may result from residual leaks. Percutaneous closure has been described though data is limited.
Methods
We compiled a registry from four centers of patients undergoing percutaneous closure of residual leaks following LAAC via surgical means or with the Watchman device. Leak severity was classified as none (no leak), mild (1-2 mm), moderate (3-4 mm), or severe (≥5 mm). Procedural and clinical success was defined as the elimination of leak or mild residual leak at the conclusion of the procedure or follow-up, respectively.
Results
Of 72 (age 72.2 ± 9.2 years; 67% male) patients, 53 had undergone prior LAAC using the Watchman device and 19 patients surgical LAAC. Mean CHADS₂ -VA₂ Sc score was 4.0 ± 1.8. The median leak size was 5 mm, range: 2-13). A total of 13 received Amplatzer Vascular Plug-II, 18 received Amplatzer Duct Occluder-II and 40 patients received coils. One underwent closure using a 21 mm-Watchman. Procedural success was 94%. Zero surgical and nine Watchman patients (13%) had a residual leak at procedural-end (five mild, three moderate, and one severe)-only one patient had no reduction in leak size. Overall leak size reduction was 94%. Two (3%) had intraoperative pericardial effusion. There were no device embolizations, device-related thrombi, or procedural deaths. Clinical success was maintained at 94%. Two had cerebrovascular accidents-at 2 days (transient ischemic attack) and 10 months postprocedure. Two had major bleeding outside the 30-day periprocedural window.
Conclusion
Percutaneous closure of residual leaks following left atrial appendage closure is feasible and associated with good outcomes. The procedural risk appears to be satisfactory.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 28 Feb 2022; epub ahead of print

Use of iso-osmolar contrast media during endovascular revascularization is associated with a lower incidence of major adverse renal, cardiac, or limb events.

Prasad A, Amin AP, Ryan MP, Gunnarsson C, Brilakis ES
Objective
We examined the association of iso-osmolar contrast media (IOCM) versus low-osmolar contrast media (LOCM) with major adverse renal, cardiovascular, or limb events in patients at high-risk of acute kidney injury (AKI) undergoing peripheral endovascular procedures.
Background
Procedural characteristics including iodinated contrast type and volume have been associated with adverse renal and cardiovascular outcomes in patients undergoing angiographic interventions.
Methods
Patients at high-risk of AKI, undergoing peripheral endovascular procedures were identified using the Premier Healthcare Database and separated into claudication and critical limb ischemia (CLI) cohorts. For each cohort, we compared IOCM versus LOCM for the primary endpoint of MARCE (major adverse renal or cardiovascular events) and secondary endpoints of major adverse renal events (MARE) and major adverse renal and limb events (MARLE). These outcomes were captured within the indexed hospitalization via adjusted multivariable regression analyses.
Results
Two procedure-based cohorts of high-risk patients were formed: claudication (N = 11,976) and CLI (N = 8713). Use of IOCM was associated with a significant absolute risk reduction (ARR) of 2.2% (p < 0.0001) for MARCE overall and in each cohort (claudication, 1.8%, p = 0.0070; CLI, 2.7%, p = 0.0054). The incidence of MARE and MARLE in the overall cohort was also lower with the use of IOCM: MARE (ARR = 1.4%, p = 0.0072) and MARLE (ARR = 2.0%, p = 0.0043).
Conclusions
Using IOCM versus LOCM in patients at high-risk of adverse renal events undergoing peripheral endovascular procedures was independently associated with lower risk of MARCE, MARE, and MARLE.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 28 Feb 2022; 99:1335-1342

Novel predictors of stent under-expansion regarding calcified coronary lesions assessed by optical coherence tomography.

Ma W, Wang Q, Wang B, Wang C, ... Chu Y, Li Y
A previous calcium scoring system using circumferential angle, thickness, and length of coronary calcium by OCT could assist in predicting stent under-expansion. However, this scoring system only reflects the calcification distribution within a single cross-section and fails to consider the lumen\'s original size. The current study aims to investigate whether novel parameters to quantify calcium lesions, including calcium burden, area, and volume assessed by optical coherence tomography (OCT), could predict stent under-expansion related to calcium lesions. Consecutive patients admitted between March 10th to October 19th 2021 with calcified coronary lesions undergoing percutaneous coronary intervention (PCI) with OCT guidance were screened for inclusion. The calcium burden, area, and volume of the target lesions were measured using OCT at pre-PCI. After successful stent implantation, stent expansion at the corresponding lesions was also measured by OCT. A total of 125 patients who underwent OCT-guided PCI were included in this study. While the calcium grades by angiography failed to show a significant correlation with stent expansion, maximum and average calcium burden, maximum calcium area, and calcium volume exhibited a moderate correlation with stent expansion. According to the receiver operating characteristic curves, the optimal cutoffs of calcium volume and area for predicting stent under-expansion were 4.37 mm³ and 2.48 mm² , respectively. Calcium burden, area, and volume by OCT are more favorable predictors of stent under-expansion given its better performance than calcium grades by angiography. Using cutoffs of calcium area and volume could identify high-risk patients of under-expansion and might guide future clinical practice.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 23 Feb 2022; epub ahead of print

Challenges and outcomes of the double kissing crush stenting technique: Insights from the PROGRESS-BIFURCATION registry.

Simsek B, Kostantinis S, Karacsonyi J, Vemmou E, ... Rangan BV, Brilakis ES
Background
Although the double kissing (DK) crush stenting technique can provide excellent outcomes in percutaneous coronary intervention (PCI) of bifurcation lesions, it can be challenging to perform.
Methods
We examined the clinical and angiographic characteristics, challenges encountered, and procedural outcomes of bifurcation PCI with DK crush in Prospective Global Registry of Percutaneous Coronary Intervention in Bifurcation Lesions (PROGRESS-BIFURCATION, NCT05100992).
Results
DK crush was used in 48 of 435 bifurcation lesions (11%). Technical success was 100%, procedural success was 96%, and the incidence of in-hospital major adverse cardiovascular events was 4%. Challenges while performing DK crush were encountered in 26 lesions (54%): (1) difficulty in side branch (SB) first rewiring (38%) that was overcome with the use of a new guidewire (30%) or a microcatheter (15%); (2) inability to deliver balloon to an SB for the first kiss (54%) that was overcome with the use of a smaller balloon (86%), rewiring (29%), microcatheter (14%), and increased support 7%; (3) difficulty in SB second rewiring (19%) that was overcome with the use of a new guidewire (80%) and/or microcatheter (60%). DK crush was more often performed in left main and proximal left anterior descending artery lesions (70% vs. 50%, p = 0.014). DK crush cases required more contrast (198 ± 84 ml vs. 163 ± 70 ml, p = 0.003), fluoroscopy time (35 ± 20 min vs. 25 ± 21 min, p = 0.004), and lasted longer (137 ± 69 min vs. 99 ± 66 min, p = 0.001) compared with non-DK crush techniques.
Conclusions
While challenges are common when performing DK crush bifurcation stenting, success rates are high and complication rates are low.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 22 Feb 2022; epub ahead of print

Modified safety techniques for transcatheter repair of superior sinus venosus defects with partial anomalous pulmonary venous drainage using a 100-mm Optimus-CVS® covered XXL stent.

Haddad RN, Bonnet D, Gewillig M, Malekzadeh-Milani S
We report the first use of a single 100-mm long custom-made version of the Optimus-CVS® balloon-expandable PTFE-covered XXL (15-Zig) stent (AndraTec, GmbH) to eliminate sinus venosus defect left-to-right shunt and redirect anomalous right pulmonary veins blood flow through a new walled channel to the left atrium. Anatomical feasibility and strategy decision were guided by ex-vivo procedure simulation on the patient-specific 3D printed heart model and in-vivo balloon interrogation. Modified procedural and implantation techniques are detailed. Immediate and one-month follow-up showed excellent outcomes.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 22 Feb 2022; epub ahead of print