Journal: Circ Cardiovasc Interv

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Abstract

Impact of Periprocedural Myocardial Injury and Infarction Definitions on Long-Term Mortality After Chronic Total Occlusion Percutaneous Coronary Intervention.

Song L, Wang Y, Guan C, Zou T, ... Qiao S, Xu B
Background
The prognostic implications of biomarker elevation following percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) lesions remain controversial. This study assessed the association of periprocedural myocardial injury and clinically relevant definition of periprocedural myocardial infarction with subsequent outcomes after CTO-PCI.
Methods
We enrolled consecutive patients between January 2010 and December 2013 who underwent CTO-PCI at a large-volume center with serial CK-MB (creatine kinase-myocardial band) or cTnI (cardiac troponin I) measurements. The primary outcome was 5-year cardiovascular death.
Results
A total of 2616 patients (2691 CTOs) with postprocedural CK-MB or cTnI undergoing PCI recanalization were included, per-lesion technical success rate was 74.4%. Postprocedural CK-MB and cTnI elevation occurred in 5.6% and 65.5% patients, respectively. For 2485 patients with serial CK-MB measurements, only postprocedural peak CK-MB ≥5× upper reference limit was associated with increased 5-year cardiovascular death (adjusted hazard ratio, 9.88 [95% CI, 3.06-31.9]). In contrast, for 1233 patients with serial cTnI measurements, no such association was present in any threshold. The Society for Cardiovascular Angiography and Interventions definition of periprocedural myocardial infarction was associated with 5-year cardiovascular death (adjusted hazard ratio, 8.45 [95% CI, 3.58-20.0]), whereas the ARC-2 (Academic Research Consortium-2) and fourth UDMI (Universal Definition of Myocardial Infarction) were not.
Conclusions
In a large cohort of CTO-PCI, moderate to high levels of peak postprocedural CK-MB were prognostically significant, whereas such association was not observed in postprocedural cTnI. The Society for Cardiovascular Angiography and Intervention criteria (but not ARC-2 and fourth UDMI) were identified as clinically relevant periprocedural myocardial infarction definition following CTO-PCI.



Circ Cardiovasc Interv: 21 Oct 2021:CIRCINTERVENTIONS121010923; epub ahead of print
Song L, Wang Y, Guan C, Zou T, ... Qiao S, Xu B
Circ Cardiovasc Interv: 21 Oct 2021:CIRCINTERVENTIONS121010923; epub ahead of print | PMID: 34674557
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Abstract

Balloon-Augmented Leaflet Modification With Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction and Laceration of the Anterior Mitral Leaflet to Prevent Outflow Obstruction: Benchtop Validation and First In-Man Experience.

Perdoncin E, Bruce CG, Babaliaros VC, Yildirim DK, ... Lederman RJ, Greenbaum AB
Background
Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) and laceration of the anterior mitral leaflet to prevent outflow obstruction (LAMPOON) reduce the risk of coronary and left ventricular outflow obstruction obstruction during transcatheter aortic valve replacement and transcatheter mitral valve replacement. Despite successful laceration, BASILICA or LAMPOON may fail to prevent obstruction caused by inadequate leaflet splay in patients having challenging anatomy such as very small valve-to-coronary distance, diffusely calcified, rigid leaflets, or undergoing transcatheter aortic valve replacement inside existing transcatheter aortic valve replacement. We describe a novel technique of balloon-augmented (BA) leaflet laceration to enhance leaflet splay.
Methods
We measured the incremental leaflet splay from BA-BASILICA in vitro. From November 2019 to March 2021, 16 patients underwent BA-BASILICA and 4 BA-LAMPOON at 3 centers.
Results
BA-BASILICA increased benchtop leaflet tip splay 17%, maximum splay angle 30%, and splay area 23%, resulting in a more rounded apex and larger effective area. Sixteen patients at risk for inadequate BASILICA leaflet splay, including 4 transcatheter aortic valve replacement inside existing transcatheter aortic valve replacement, underwent BA-BASILICA. All had successful leaflet laceration. One had coronary obstruction requiring immediate orthotopic stenting. Two underwent elective orthotopic coronary stenting through the transcatheter valve cells for leaflet prolapse without coronary ischemia. There were no deaths during the procedure or at 30 days. Four patients at risk for inadequate anterior mitral leaflet splay underwent BA-LAMPOON. All had successful target leaflet laceration without left ventricular outflow obstruction obstruction or procedural death. One died within 30 days.
Conclusions
BA leaflet laceration enhances leaflet splay in vitro and may allow transcatheter aortic valve replacement and transcatheter mitral valve replacement in patients otherwise ineligible for traditional BASILICA or LAMPOON due to challenging anatomy.



Circ Cardiovasc Interv: 21 Oct 2021:CIRCINTERVENTIONS121011028; epub ahead of print
Perdoncin E, Bruce CG, Babaliaros VC, Yildirim DK, ... Lederman RJ, Greenbaum AB
Circ Cardiovasc Interv: 21 Oct 2021:CIRCINTERVENTIONS121011028; epub ahead of print | PMID: 34674556
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Abstract

Prognostic Impact of Pancoronary Quantitative Flow Ratio Assessment in Patients Undergoing Percutaneous Coronary Intervention for Acute Coronary Syndromes.

Erbay A, Penzel L, Abdelwahed YS, Klotsche J, ... Stähli BE, Leistner DM
Background
Quantitative flow ratio (QFR) has been introduced as a novel angiography-based modality for fast hemodynamic assessment of coronary artery lesions and validated against fractional flow reserve. This study sought to define the prognostic role of pancoronary QFR assessment in patients with acute coronary syndrome (ACS) including postinterventional culprit and nonculprit vessels.
Methods
In a total of 792 patients with ACS (48.6% ST-segment-elevation ACS and 51.4% non-ST-segment-elevation ACS), QFR analyses of postinterventional culprit (n=792 vessels) and nonculprit vessels (n=1231 vessels) were post hoc performed by investigators blinded to clinical outcomes. The follow-up comprised of major adverse cardiovascular events, including all-cause mortality, nonfatal myocardial infarction, and ischemia-driven coronary revascularization within 2 years after the index ACS event.
Results
Major adverse cardiovascular events as composite end point occurred in 99 patients (12.5%). QFR with an optimal cutoff value of 0.89 for postinterventional culprit vessels and 0.85 for nonculprit vessels emerged as independent predictor of major adverse cardiovascular events after ACS (nonculprit arteries: adjusted odds ratio, 3.78 [95% CI, 2.21-6.45], P<0.001 and postpercutaneous coronary intervention culprit arteries: adjusted odds ratio, 3.60 [95% CI, 2.09-6.20], P<0.001).
Conclusions
The present study for the first time demonstrates the prognostic implications of a pancoronary angiography-based functional lesion assessment in patients with ACS. Hence, QFR offers a novel tool to advance risk stratification and guide therapeutic management after ACS.



Circ Cardiovasc Interv: 21 Oct 2021:CIRCINTERVENTIONS121010698; epub ahead of print
Erbay A, Penzel L, Abdelwahed YS, Klotsche J, ... Stähli BE, Leistner DM
Circ Cardiovasc Interv: 21 Oct 2021:CIRCINTERVENTIONS121010698; epub ahead of print | PMID: 34674555
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Abstract

Association Between Stent Implantation and Progression of Nontarget Lesions in a Rabbit Model of Atherosclerosis.

Ma J, Liu X, Qiao L, Meng L, ... Zhang C, Zhang Y
Background
Progression of nontarget lesions (NTLs) after percutaneous coronary intervention (PCI) has been reported. However, it remains unknown whether progression of NTLs was causally related to stenting. This study was undertaken to test the hypothesis that stent implantation triggers acute phase response and systemic inflammation which may be associated with progression of NTLs.
Methods
Thirty New Zealand rabbits receiving endothelial denudation and atherogenic diet were randomly divided into stenting, sham, and control groups. Angiography and intravascular ultrasonography were performed in the stenting and sham groups, and stent implantation performed only in the stenting group. Histopathologic study was conducted and serum levels of APPs (acute phase proteins) measured in all rabbits. Proteomics analysis was performed to screen the potential proteins related to NTLs progression after stent implantation. The serum levels of APPs and inflammatory cytokines were measured in 147 patients undergoing coronary angiography or PCI.
Results
Plaque burden in the NTLs was significantly increased 12 weeks after stent implantation in the stenting group versus sham group. Serum levels of APPs and their protein expression in NTLs were significantly increased and responsible for stenting-triggered inflammation. In patients receiving PCI, serum levels of SAA-1 (serum amyloid A protein 1), CRP (C-reactive protein), TNF (tumor necrosis factor)-α, and IL (interleukin)-6 were substantially elevated up to 1 month post-PCI.
Conclusions
In a rabbit model of atherosclerosis, stent implantation triggered acute phase response and systemic inflammation, which was associated with increased plaque burden and pathological features of unstable plaque in NTLs. The potential mechanism involved vessel injury-triggered acute phase response manifested as increased serum levels of SAA-1, CRP, and LBP (lipopolysaccharide-binding protein) and their protein expression in NTLs. These findings provided a new insight into the relation between stent implantation and progression of NTLs, and further studies are warranted to clarify the detailed mechanism and clinical significance of these preliminary results.
Registration
URL: http://www.chictr.org.cn; Unique identifier: ChiCTR1900026393.



Circ Cardiovasc Interv: 21 Oct 2021:CIRCINTERVENTIONS121010764; epub ahead of print
Ma J, Liu X, Qiao L, Meng L, ... Zhang C, Zhang Y
Circ Cardiovasc Interv: 21 Oct 2021:CIRCINTERVENTIONS121010764; epub ahead of print | PMID: 34674554
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Abstract

Midterm Outcomes Following Sutureless and Transcatheter Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.

Vilalta V, Alperi A, Cediel G, Mohammadi S, ... Bayés-Genís A, Rodés-Cabau J
Background
Sutureless-surgical aortic valve replacement (SU-SAVR) has been proposed as a surgical alternative for treating aortic stenosis, which facilitates a minimally invasive approach. While some studies have compared the early outcomes of SU-SAVR versus transcatheter aortic valve replacement (TAVR), most data were obtained in high-risk patients and/or limited to in-hospital outcomes. This study aimed to compare in-hospital and midterm clinical outcomes following SU-SAVR and TAVR in low-risk patients with aortic stenosis.
Methods
A total of 806 consecutive low-risk (EuroSCORE II <4%) patients underwent TAVR or SU-SAVR between 2011 and 2020 in 2 centers. A 1:1 propensity score matching was performed and identified 171 pairs with similar characteristics that were included in the analysis. Baseline characteristics, in-hospital and follow-up events (defined according to Valve Academic Research Consortium-2) were collected.
Results
Baseline characteristics were well balanced between groups, with a median EuroSCORE II of 1.9% (1.3%-2.5%) in both SU-SAVR and TAVR groups (P=0.85). There were no statistically significant differences regarding in-hospital mortality (SU-SAVR: 4.1%, TAVR: 1.8%, P=0.199) and stroke (SU-SAVR: 2.3%, TAVR: 2.9%, P=0.736), but SU-SAVR recipients exhibited higher rates of bleeding and new-onset atrial fibrillation, higher residual transvalvular gradients (P<0.001), and a lower rate of pacemaker implantation (P=0.011). After a median follow-up of 2 (1-3) years, there were no differences between groups in all-cause mortality (hazard ratio, 0.97 [95% CI, 0.52-1.82], P=0.936) and stroke (hazard ratio, 0.83 [95% CI, 0.32-2.15], P=0.708), but SU-SAVR was associated with a higher risk of heart failure hospitalization (hazard ratio, 5.38 [95% CI, 1.88-15.38], P=0.002).
Conclusions
In low-risk patients with aortic stenosis, TAVR was associated with improved in-hospital outcomes (except for conduction disturbances) and valve hemodynamics, compared with SU-SAVR. Although similar mortality and stroke rates were observed at 2-year follow-up, the risk of heart failure hospitalization was higher among SU-SAVR patients. These results may contribute to reinforce TAVR over SU-SAVR for the majority of such patients.



Circ Cardiovasc Interv: 04 Oct 2021:CIRCINTERVENTIONS121011120; epub ahead of print
Vilalta V, Alperi A, Cediel G, Mohammadi S, ... Bayés-Genís A, Rodés-Cabau J
Circ Cardiovasc Interv: 04 Oct 2021:CIRCINTERVENTIONS121011120; epub ahead of print | PMID: 34607449
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Abstract

Pretreatment With P2Y12 Inhibitors in Patients With Chronic Coronary Syndrome Undergoing Percutaneous Coronary Intervention: A Report From the Swedish Coronary Angiography and Angioplasty Registry.

Jurga J, Szummer KE, Lewinter C, Mellbin L, ... Jernberg T, Venetsanos D
Background
In patients with chronic coronary syndrome undergoing percutaneous coronary intervention, the optimal timing of P2Y12 inhibitors\' administration is uncertain. We compared pretreatment versus treatment in the catheterization laboratory (In-Cathlab) in a real-world population.
Methods
In Swedish Coronary Angiography and Angioplasty Registry, all patients with chronic coronary syndrome undergoing coronary angiography and ad hoc percutaneous coronary intervention, between 2006 and 2017 were identified. Pretreatment was defined as P2Y12 inhibitor administration before coronary angiography, outside the catheterization laboratory. Outcomes were net adverse clinical events including death, myocardial infarction, stroke, or bleeding within 30 days of the index procedure and in-hospital bleeding.
Results
We included 26 814 patients, 8237 in the In-Cathlab, and 18 577 in the pretreatment group. In-Cathlab treatment compared with pretreatment was associated with lower risk for net adverse clinical event (4.2 versus 5.1%, adjusted hazard ratio 0.79 [0.63-0.99]), bleeding (2.3 versus 2.6%, adjusted hazard ratio, 0.76 [0.57-1.01]). and in-hospital bleeding (1.9 versus 2.1%, adjusted odds ratio, 0.70 [0.51-0.96]). The risk for death, myocardial infarction, or stroke did not significantly differ between the groups. Among the In-Cathlab treated patients, 41% received ticagrelor or prasugrel and 59% clopidogrel. Treatment with ticagrelor or prasugrel was associated with higher risk for net adverse clinical events (5.4% versus 3.4%, adjusted hazard ratio, 1.66 [1.12-2.48]), bleeding (3.4 versus 1.6%, adjusted hazard ratio, 2.14 [1.34-3.42]), and in-hospital bleeding (2.9 versus 1.2%, adjusted odds ratio, 2.24 [1.29-3.90]) but similar risk for death, myocardial infarction, or stroke, compared with clopidogrel.
Conclusions
In patients with chronic coronary syndrome undergoing coronary angiography and ad hoc percutaneous coronary intervention, pretreatment with P2Y12 inhibitors, before arrival to the catheterization laboratory, was not associated with improved clinical outcomes but was associated with increased risk for bleeding. Our data support clopidogrel administration in the catheterization laboratory as the standard of care.



Circ Cardiovasc Interv: 30 Sep 2021:CIRCINTERVENTIONS121010849; epub ahead of print
Jurga J, Szummer KE, Lewinter C, Mellbin L, ... Jernberg T, Venetsanos D
Circ Cardiovasc Interv: 30 Sep 2021:CIRCINTERVENTIONS121010849; epub ahead of print | PMID: 34592825
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Abstract

Ultrasound- Versus Fluoroscopy-Guided Strategy for Transfemoral Transcatheter Aortic Valve Replacement Access: A Systematic Review and Meta-Analysis.

Kotronias RA, Bray JJH, Rajasundaram S, Vincent F, ... Van Belle E, Banning AP
Background
Access site vascular and bleeding complications remain problematic for patients undergoing transcatheter aortic valve replacement (TAVR). Ultrasound-guided transfemoral access approach has been suggested as a technique to reduce access site complications, but there is wide variation in adoption in TAVR. We performed a systematic review and meta-analysis to compare access site vascular and bleeding complications according to the Valve Academic Research Consortium-2 classification following the use of either ultrasound- or conventional fluoroscopy-guided transfemoral TAVR access.
Methods
Medline, Embase, Web of Science, and The Cochrane Library were searched to November 2020 for studies comparing ultrasound- and fluoroscopy-guided access for transfemoral TAVR. A priori defined primary outcomes were extracted: (1) major, (2) minor, and (3) major and minor (total) access site vascular complications and (4) life-threatening/major, (5) minor, and (6) life-threatening, major, and minor (total) access site bleeding complications.
Results
Eight observational studies (n=3875) were included, with a mean participant age of 82.8 years, STS score 5.81, and peripheral vascular disease in 23.5%. An ultrasound-guided approach was significantly associated with a reduced risk of total (Mantel-Haenszel odds ratio [MH-OR], 0.50 [95% CI, 0.35-0.73]), major (MH-OR, 0.51 [95% CI, 0.35-0.74]), and minor (MH-OR, 0.59 [95% CI, 0.38-0.91]) access site vascular complications. Ultrasound guidance was also significantly associated with total access site bleeding complications (MH-OR, 0.59 [95% CI, 0.39-0.90]). The association remained significant in sensitivity analyses of maximally adjusted minor and total vascular access site complications (MH-OR, 0.51 [95% CI, 0.29-0.90]; MH-OR, 0.44 [95% CI, 0.20-0.99], respectively).
Conclusions
In the absence of randomized studies, our data suggests a potential benefit for ultrasound guidance to obtain percutaneous femoral access in TAVR.
Registration
URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42020218259.



Circ Cardiovasc Interv: 19 Sep 2021:CIRCINTERVENTIONS121010742; epub ahead of print
Kotronias RA, Bray JJH, Rajasundaram S, Vincent F, ... Van Belle E, Banning AP
Circ Cardiovasc Interv: 19 Sep 2021:CIRCINTERVENTIONS121010742; epub ahead of print | PMID: 34538068
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Abstract

Bleeding and Subsequent Cardiovascular Events and Death in Atrial Fibrillation With Stable Coronary Artery Disease: Insights From the AFIRE Trial.

Kaikita K, Yasuda S, Akao M, Ako J, ... Ogawa H, AFIRE Investigators
Background
Early bleeding after percutaneous coronary intervention is associated with increased risk of death and myocardial infarction; however, the association between bleeding and subsequent major adverse cardiac and cerebrovascular events (MACCE) remains unclear in patients with atrial fibrillation and stable coronary artery disease. We thus aimed to investigate this association.
Methods
The AFIRE trial (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) was a multicenter, open-label trial conducted in Japan. This post hoc analysis included 2215 patients with atrial fibrillation and stable coronary artery disease treated with rivaroxaban or rivaroxaban plus an antiplatelet agent. MACCE was defined as a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause. The association of bleeding with subsequent MACCE risk was investigated using time-adjusted Cox multivariate analysis after adjusting for baseline characteristics and time from bleeding. Bleeding events were classified according to the International Society on Thrombosis and Haemostasis criteria.
Results
Among the 2215 patients, 386 (17.4%) had bleeding during follow-up, of whom 63 (16.3%) also experienced MACCE; MACCE incidence was higher in patients with bleeding than in those without (8.38% versus 4.20% per patient-year; hazard ratio, 2.01 [95% CI, 1.49-2.70]; P<0.001). The proportion of patients with both bleeding and MACCE (developed after bleeding) was 73.0% (46 of 63); 27.0% (17 of 63) experienced MACCE before bleeding. Time-adjusted Cox multivariate analysis revealed a temporal association between major bleeding and subsequent MACCE, with particularly high MACCE risks within 30 days after major bleeding (hazard ratio, 7.81 [95% CI, 4.20-14.54]).
Conclusions
In patients with atrial fibrillation and stable coronary artery disease, major bleeding was strongly associated with subsequent MACCE. Thus, it is important to prevent major bleeding to avoid cardiovascular events and death. Registration: URL: https://www.umin.ac.jp/ctr; Unique identifier: UMIN000016612. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02642419.



Circ Cardiovasc Interv: 02 Sep 2021:CIRCINTERVENTIONS120010476; epub ahead of print
Kaikita K, Yasuda S, Akao M, Ako J, ... Ogawa H, AFIRE Investigators
Circ Cardiovasc Interv: 02 Sep 2021:CIRCINTERVENTIONS120010476; epub ahead of print | PMID: 34474583
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Abstract

Transcatheter Mitral Valve Implantation: Current Status and Future Perspectives.

Russo G, Gennari M, Gavazzoni M, Pedicino D, ... Taramasso M, Maisano F
Mitral transcatheter therapies represent the treatment of choice for all patients deemed unsuitable for cardiac surgery. So far, the largest clinical experience has been limited to percutaneous repair techniques. However, given the complexity and heterogeneity of mitral valve anatomy and pathology, transcatheter mitral valve implantation will widen the mitral valve therapies horizon, toward a patient-tailored approach. Current data about transcatheter mitral valve implantation is still limited and, although some data are promising, there are still some issues to be addressed. This review provides a comprehensive insight into the available devices and describes potential advantages and limitations of transcatheter mitral valve implantation.



Circ Cardiovasc Interv: 30 Aug 2021; 14:e010628
Russo G, Gennari M, Gavazzoni M, Pedicino D, ... Taramasso M, Maisano F
Circ Cardiovasc Interv: 30 Aug 2021; 14:e010628 | PMID: 34407621
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Abstract

Compared Outcomes of ST-Elevation Myocardial Infarction Patients with Multivessel Disease Treated with Primary Percutaneous Coronary Intervention and Preserved Fractional Flow Reserve of Non-Culprit Lesions Treated Conservatively and of Those with Low Fractional Flow Reserve Managed Invasively: Insights from the FLOWER MI trial.

Denormandie P, Simon T, Cayla G, Steg PG, ... Danchin N, Puymirat E
Background: In patients with ST-elevation myocardial infarction (STEMI) and multivessel disease, percutaneous coronary intervention (PCI) for non-culprit lesions guided by FFR is superior to treatment of the culprit lesion alone. Whether deferring non-culprit PCI is safe in this specific context is questionable. We aimed to assess clinical outcomes at one-year in STEMI patients with multivessel coronary artery disease and an FFR-guided strategy for non-culprit lesions, according to whether or not ≥1 PCI was performed.
Methods:
Outcomes were analyzed in patients of the randomized FLOWER MI (Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction) trial in whom, after successful primary PCI, non-culprit lesions were assessed using FFR. The primary outcome was a composite of all-cause death, non-fatal MI, and unplanned hospitalization with urgent revascularization at one year.
Results:
Among 1,171 patients enrolled in this study, 586 were assigned to the FFR-guided group: 388 (66%) of them had ≥1 PCI and 198 (34%) had no PCI. Mean FFR before decision (i.e., PCI or not) of non-culprit lesions were 0.75±0.10 and 0.88±0.06, respectively. During follow-up, a primary outcome event occurred in 16 of 388 patients (4.1%) in patients with PCI and in 16 of 198 patients (8.1%) in patients without PCI (adjusted hazard ratio, 0.42; 95% confidence interval, 0.20 to 0.88; P = 0.02). Conclusions: In patients with STEMI undergoing complete revascularization guided by FFR measurement, those with ≥1 PCI had lower event rates at 1 year, compared with patients with deferred PCI, suggesting that deferring lesions judged relevant by visual estimation but with FFR >0.80 may not be optimal in this context. Future randomized studies are needed to confirm this data.




Circ Cardiovasc Interv: 22 Aug 2021; epub ahead of print
Denormandie P, Simon T, Cayla G, Steg PG, ... Danchin N, Puymirat E
Circ Cardiovasc Interv: 22 Aug 2021; epub ahead of print | PMID: 34420366
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Abstract

Hypothermia for Reduction of Myocardial Reperfusion Injury in Acute Myocardial Infarction: Closing the Translational Gap.

El Farissi M, Keulards DCJ, Zelis JM, van \'t Veer M, ... Pijls NHJ, Otterspoor LC
Myocardial reperfusion injury-triggered by an inevitable inflammatory response after reperfusion-may undo a considerable part of the myocardial salvage achieved through timely percutaneous coronary intervention in patients with acute myocardial infarction. Because infarct size is strongly correlated to mortality and risk of heart failure, the importance of endeavors for cardioprotective therapies to attenuate myocardial reperfusion injury and decrease infarct size remains undisputed. Myocardial reperfusion injury is the result of several complex nonlinear phenomena, and for a therapy to be effective, it should act on multiple targets involved in this injury. In this regard, hypothermia remains a promising treatment despite a number of negative randomized controlled trials in humans with acute myocardial infarction so far. To turn the tide for hypothermia in patients with acute myocardial infarction, sophisticated solutions for important limitations of systemic hypothermia should continue to be developed. In this review, we provide a comprehensive overview of the pathophysiology and clinical expression of myocardial reperfusion injury and discuss the current status and possible future of hypothermia for cardioprotection in patients with acute myocardial infarction.



Circ Cardiovasc Interv: 30 Jul 2021; 14:e010326
El Farissi M, Keulards DCJ, Zelis JM, van 't Veer M, ... Pijls NHJ, Otterspoor LC
Circ Cardiovasc Interv: 30 Jul 2021; 14:e010326 | PMID: 34266310
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Abstract

Transcatheter Aortic Valve Replacement for Bicuspid Aortic Valve Stenosis: A Practical Operative Overview.

Tarantini G, Fabris T
The bicuspid aortic valve (BAV) represents a complex anatomic scenario for transcatheter aortic valve replacement (TAVR) because of its unique technical challenges. As TAVR is moving towards younger and lower-risk populations, the proportion of BAV patients undergoing TAVR is expected to rise. Initial experiences of TAVR with first-generation transcatheter heart valves in high surgical risk patients with BAV stenosis showed higher rates of device failure and periprocedural complications as compared to tricuspid anatomy. The subsequent advances in imaging techniques and understanding of BAV anatomy, new iterations of transcatheter heart valves, and growing operators\' experience yielded better outcomes. However, in the lack of randomized trials and rigorous evidence, the field of TAVR in BAV has been driven by empirical observations, with wide variability in transcatheter heart valve sizing and implantation techniques across different centers and operators. Thus, in this review article, we provide a fully illustrated overview of operative periprocedural steps for TAVR in BAV stenosis, though recognizing that it still remains anecdotal.



Circ Cardiovasc Interv: 29 Jun 2021; 14:e009827
Tarantini G, Fabris T
Circ Cardiovasc Interv: 29 Jun 2021; 14:e009827 | PMID: 34130478
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Abstract

Calcific Plaque Modification by Acoustic Shock Waves: Intravascular Lithotripsy in Coronary Interventions.

Karimi Galougahi K, Patel S, Shlofmitz RA, Maehara A, ... Stone GW, Ali ZA
Constituting a significant proportion of lesions treated with transcatheter interventions in the coronary arteries, moderate-to-severe calcification portends lower procedural success rates, increased periprocedural major adverse events, and unfavorable long-term clinical outcomes compared with noncalcific plaques. Adapted from the lithotripsy technology for treatment of nephrolithiasis, intravascular lithotripsy is a new technique for treatment of severely calcific lesions that uses acoustic shock waves in a balloon-based system to induce fracture in the calcium deposits to facilitate luminal gain and stent expansion. Herein, we summarize the physics and characteristics of the currently available intravascular lithotripsy system (Shockwave Medical, Santa Clara, CA), the clinical data on intravascular lithotripsy use in the coronary arteries, and future directions for adoption of the technique in percutaneous coronary intervention.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009354
Karimi Galougahi K, Patel S, Shlofmitz RA, Maehara A, ... Stone GW, Ali ZA
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009354 | PMID: 32907343
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Abstract

Percutaneous Axillary Access for Placement of Microaxial Ventricular Support Devices: The Axillary Access Registry to Monitor Safety (ARMS).

McCabe JM, Kaki AA, Pinto DS, Kirtane AJ, ... Kapur NK, Tayal R
Background
There has been increasing utilization of short-term mechanical circulatory support devices for a variety of clinical indications. Many patients have suboptimal iliofemoral access options or reasons why early mobilization is desirable. Axillary artery access is an option for these patients, but little is known about the utility of this approach to facilitate short-term use for circulatory support with microaxial pump devices.
Methods
The Axillary Access Registry to Monitor Safety (ARMS) was a prospective, observational multicenter registry to study the feasibility and acute safety of mechanical circulatory support via percutaneous upper-extremity access.
Results
One hundred and two patients were collected from 10 participating centers. Successful device implantation was 98% (100 of 102). Devices were implanted for a median of 2 days (interquartile range, 0-5 days; range, 0-35 days). Procedural complications included 10 bleeding events and 1 stroke. There were 3 patients with brachial plexus-related symptoms all consisting of C8 tingling and all arising after multiple days of support. Postprocedural access site hematoma or bleeding was noted in 9 patients. Device explantation utilized closure devices alone in 61%, stent grafts in 17%, balloon tamponade facilitated closure in 15%, and planned surgical explant in 5%. Duration of support appeared to be independently associated with a 1.1% increased odds of vascular complication per day ([95% CI, 0.0%-2.3%] P=0.05).
Conclusions
Percutaneous axillary access for use with microaxial support pumps appears feasible with acceptable rates of bleeding despite early experience. Larger studies are necessary to confirm the pilot data presented here.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009657
McCabe JM, Kaki AA, Pinto DS, Kirtane AJ, ... Kapur NK, Tayal R
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009657 | PMID: 33322918
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Abstract

Feasibility and Validity of Computed Tomography-Derived Fractional Flow Reserve in Patients With Severe Aortic Stenosis: The CAST-FFR Study.

Michail M, Ihdayhid AR, Comella A, Thakur U, ... Ko BS, Brown AJ
Background
Coronary artery disease is common in patients with severe aortic stenosis. Computed tomography-derived fractional flow reserve (CT-FFR) is a clinically used modality for assessing coronary artery disease, however, its use has not been validated in patients with severe aortic stenosis. This study assesses the safety, feasibility, and validity of CT-FFR in patients with severe aortic stenosis.
Methods
Prospectively recruited patients underwent standard-protocol invasive FFR and coronary CT angiography (CTA). CTA images were analyzed by central core laboratory (HeartFlow, Inc) for independent evaluation of CT-FFR. CT-FFR data were compared with FFR (ischemia defined as FFR ≤0.80).
Results
Forty-two patients (68 vessels) underwent FFR and CTA; 39 patients (92.3%) and 60 vessels (88.2%) had interpretable CTA enabling CT-FFR computation. Mean age was 76.2±6.7 years (71.8% male). No patients incurred complications relating to premedication, CTA, or FFR protocol. Mean FFR and CT-FFR were 0.83±0.10 and 0.77±0.14, respectively. CT calcium score was 1373.3±1392.9 Agatston units. On per vessel analysis, there was positive correlation between FFR and CT-FFR (Pearson correlation coefficient, R=0.64, P<0.0001). Sensitivity, specificity, positive predictive value, and negative predictive values were 73.9%, 78.4%, 68.0%, and 82.9%, respectively, with 76.7% diagnostic accuracy. The area under the receiver-operating characteristic curve for CT-FFR was 0.83 (0.72-0.93, P<0.0001), which was higher than that of CTA and quantitative coronary angiography (P=0.01 and P<0.001, respectively). Bland-Altman plot showed mean bias between FFR and CT-FFR as 0.059±0.110. On per patient analysis, the sensitivity, specificity, positive predictive, and negative predictive values were 76.5%, 77.3%, 72.2%, and 81.0% with 76.9% diagnostic accuracy. The per patient area under the receiver-operating characteristic curve analysis was 0.81 (0.67-0.95, P<0.0001).
Conclusions
CT-FFR is safe and feasible in patients with severe aortic stenosis. Our data suggests that the diagnostic accuracy of CT-FFR in this cohort potentially enables its use in clinical practice and provides the foundation for future research into the use of CT-FFR for coronary evaluation pre-aortic valve replacement.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009586
Michail M, Ihdayhid AR, Comella A, Thakur U, ... Ko BS, Brown AJ
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009586 | PMID: 33322917
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Impact:
Abstract

First-in-Human Study to Assess the Safety and Feasibility of the Bashir Endovascular Catheter for the Treatment of Acute Intermediate-Risk Pulmonary Embolism.

Sista AK, Bhatheja R, Rali P, Natarajan K, ... Bashir R, Rosenfield K
Background
The Bashir Endovascular Catheter (BEC) is a novel pharmaco-mechanical device designed to enhance thrombolysis by increasing the exposure of thrombus to endogenous and exogenous thrombolytics. The aim of this prospective, multicenter, single-arm study was to evaluate the feasibility and initial safety of the BEC in patients with acute intermediate-risk pulmonary embolism (PE).
Methods
Patients with symptomatic PE and right ventricular to left ventricular diameter ratio ≥0.9 as documented by computer tomography angiography were eligible for enrollment. The primary safety end points were device related death or adverse events, and major bleeding within 72 hours after BEC directed therapy.
Results
Nine patients were enrolled across 4 US sites. The total dose of r-tPA (recombinant tissue-type plasminogen activator) was 14 mgs in bilateral PE and 12 mgs in unilateral PE over 8 hours delivered via the expanded BEC. At 30-day follow-up, there were no deaths or device-related adverse events. At 48 hours post-BEC therapy, the right ventricular to left ventricular diameter ratio decreased from 1.52±0.26 to 0.97±0.06 (P=0.0009 [95% CI, 0.33-0.82]; 37.0% reduction). Thrombus burden as measured by the Modified Miller Index decreased from 25.4±5.3 to 16.0±4.0 (P=0.0005; [95% CI, 5.5-13.4]; 37.1% reduction).
Conclusions
In this early feasibility study of the BEC for intermediate-risk PE, there were no deaths or device-related adverse events and a significant reduction in right ventricular to left ventricular diameter ratio and thrombus burden. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03927508.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009611
Sista AK, Bhatheja R, Rali P, Natarajan K, ... Bashir R, Rosenfield K
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009611 | PMID: 33356383
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Impact:
Abstract

Clinical and Anatomic Complexity of Patients Undergoing Coronary Intervention With and Without On-Site Surgical Capabilities: Insights From the Veterans Affairs Clinical Assessment, Reporting and Tracking (CART) Program.

Waldo SW, Hebbe A, Grunwald GK, Doll JA, Schofield R
Background
Professional society consensus statements articulate the clinical and anatomic complexity of patients that may undergo percutaneous coronary intervention (PCI) without on-site cardiothoracic surgery, although compliance with these recommendations has not been assessed. We sought to evaluate the clinical and anatomic complexity of patients undergoing PCI with and without cardiothoracic surgery on-site.
Methods
We identified all patients undergoing PCI in the Veterans Affairs health care system between October 2009 and September 2017. The clinical and anatomic complexity of patients treated at sites with or without cardiothoracic surgery was evaluated with a comparative interrupted time series, and mortality was ascertained in a propensity-matched cohort.
Results
We identified 75 564 patients who underwent PCI, with the majority (53 708, 71%) treated at sites with cardiothoracic surgery. The overall clinical complexity was statistically greater for those treated at sites with cardiothoracic surgery (National Cardiovascular Data Registries CathPCI: 18.4) compared with those at sites without (17.8, P<0.001) throughout the study, with similar annual increases in complexity before (2% versus 3%; P=0.107) and after (3% versus 3%; P=0.704) January 2014. The anatomic complexity of patients treated was also statistically greater (Veterans Affairs SYNTAX: 11.0 versus 10.2; P<0.001) and increased at comparable rates (2% versus 1%, P=0.731) before 2014. After publication of the consensus statement, anatomic complexity declined at sites with cardiothoracic surgery (-2%) but increased at sites without on-site surgery (5%, P=0.025) such that it was similar at the end of the study (P=0.622). Referrals for emergent cardiothoracic surgery were rare regardless of treatment venue (61, 0.08%) and the hazard for mortality was similar (hazard ratio, 0.883 [95% CI, 0.662-1.176]) after propensity matching.
Conclusions
There are minor differences in complexity of patients undergoing coronary intervention at sites with and without cardiothoracic surgery. Clinical outcomes are similar regardless of treatment venue, suggesting an opportunity to improve access to complex interventional care without sacrificing quality.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009697
Waldo SW, Hebbe A, Grunwald GK, Doll JA, Schofield R
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009697 | PMID: 33354988
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Impact:
Abstract

Heart Team/Guidelines Discordance Is Associated With Increased Mortality: Data From a National Survey of Revascularization in Patients With Complex Coronary Artery Disease.

Witberg G, Segev A, Barac YD, Raanani E, ... Goldenberg I, Kornowski R
Background
Practice guidelines emphasize the role of the SYNTAX score (SS; Synergy Between PCI With TAXUS and Cardiac Surgery) in choosing between percutaneous coronary intervention and coronary artery bypass graft surgery in cases of complex coronary artery disease. There is paucity of data on the implementation of these recommendations in daily practice, and on the consequences of guideline discordant revascularization.
Methods
This was a retrospective analysis of a prospective national survey of consecutive real world patients undergoing coronary revascularization for complex coronary artery disease according to decisions of local heart team at each center. SS was calculated at a dedicated CoreLab, and patients were classified as heart team/guidelines agreement/discordant.
Results
Nine hundred seventy-nine patients (571 percutaneous coronary intervention and 408 coronary artery bypass graft) were included. Mean age was 65 years and the mean SS was 22. Heart team/guidelines discordance occurred in 170 (17.3%) patients. Independent predictors of heart team/guidelines discordance were age, admission to a center with no cardiac surgery service, SS, and previous percutaneous coronary intervention/myocardial infarction. A multivariate model based on these characteristics had a C statistic of 0.83. Thirty-day outcomes were similar in the agreement/discordance groups, however, heart team/guidelines discordance was associated with a significant increase in 3 year mortality (17.6% versus 8.4%; hazard ratio, 2.05; P=0.002) after multivariate adjustment.
Conclusions
Heart team/guidelines discordance is not infrequent in real world patients with complex coronary artery disease undergoing revascularization. This is more likely to occur in elderly patients, those with more complex coronary disease (as determined by the SS), and those treated at centers with no cardiac surgery service. These patients have a higher risk for mid-term mortality.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009686
Witberg G, Segev A, Barac YD, Raanani E, ... Goldenberg I, Kornowski R
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009686 | PMID: 33423541
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Impact:
Abstract

Randomized Trial of Aspirin Versus Warfarin After Transcatheter Aortic Valve Replacement in Low-Risk Patients.

Rogers T, Shults C, Torguson R, Shea C, ... Satler LF, Waksman R
Background
The optimal antithrombotic regimen after transcatheter aortic valve replacement remains unclear.
Methods
In this randomized open-label study, low-risk patients undergoing transfemoral transcatheter aortic valve replacement at 7 centers in the United States were randomized 1:1 to low-dose aspirin or warfarin plus low-dose aspirin for 30 days. Patients who could not be randomized were enrolled in a separate registry. Computed tomography or transesophageal echocardiography was performed at 30 days. The primary effectiveness end point was a composite of the following at 30 days: hypoattenuated leaflet thickening, at least moderately reduced leaflet motion, hemodynamic dysfunction (mean aortic valve gradient ≥20 mm Hg, effective orifice area ≤1.0 cm2, dimensionless valve index <0.35, or moderate or severe aortic regurgitation), stroke, or transient ischemic attack.
Results
Between July 2018 and October 2019, 94 patients were randomly assigned, 50 to aspirin and 44 to warfarin plus aspirin, and 30 were enrolled into the registry. In the intention-to-treat analysis of the randomized cohort, the composite primary effectiveness end point was met in 26.5% for aspirin versus 7.0% for warfarin plus aspirin (P=0.014; odds ratio, 4.8 [95% CI, 1.3-18.3]). The rate of hypoattenuated leaflet thickening was 16.3% for aspirin versus 4.7% for warfarin plus aspirin (P=0.07; odds ratio, 4.0 [95% CI, 0.8-20.0]). There was no excess bleeding at 30 days with anticoagulation. In the as-treated analysis of pooled randomized and registry cohorts, the rate of hypoattenuated leaflet thickening was 16.7% for aspirin versus 3.1% for warfarin plus aspirin (P=0.011; odds ratio, 6.3 [95% CI, 1.3-30.6]).
Conclusions
In low-risk transcatheter aortic valve replacement patients, anticoagulation with warfarin may prevent transcatheter heart valve dysfunction in the short term without excess bleeding. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03557242.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009983
Rogers T, Shults C, Torguson R, Shea C, ... Satler LF, Waksman R
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009983 | PMID: 33423540
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Impact:
Abstract

Safety and Feasibility of Same-Day Discharge After Left Atrial Appendage Closure With the WATCHMAN Device.

Tan BE, Boppana LKT, Abdullah AS, Chuprun D, ... Bhatt DL, Depta JP
Background
As the use of left atrial appendage closure (LAAC) becomes more widespread, improvements in resource utilization and cost-effectiveness are necessary. Currently, there are limited data on same-day discharge (SDD) after LAAC. We aimed to evaluate the safety and feasibility of SDD versus non-SDD in patients with nonvalvular atrial fibrillation who underwent LAAC.
Methods
We retrospectively studied 211 patients who underwent the WATCHMAN procedure in a tertiary hospital (June 2016 to June 2019). The primary safety outcome was the composite of stroke, systemic embolism, major bleeding requiring transfusion, vascular complications requiring endovascular intervention, or death through 7 days (periprocedural) and 45 days post-procedure. The secondary outcomes were the individual components of the primary outcome and all-cause readmission. We compared the clinical outcomes of patients who had SDD and non-SDD post-procedure.
Results
Patients with procedure-related complications on the day of LAAC and patients who were admitted for acute clinical events before LAAC were excluded. One hundred ninety patients were included in the final analysis. Seventy-two of 190 (38%) patients had SDD, and 118 of 190 (62%) had non-SDD. There were no statistically significant differences in the primary safety outcome through 7 days (1.4% versus 5.9%; P=0.26) and 45 days post-procedure (2.8% versus 9.3%; P=0.14) between the two groups. The secondary outcomes were similar in both groups. No patients had device-related thrombus on transesophageal echocardiography at 45 days. Only 1 patient from the non-SDD group had clinically significant peri-device flow (>5 mm) at 45 days.
Conclusions
In a selected cohort of patients who underwent successful elective LAAC with WATCHMAN without same-day procedure-related complications, the primary safety outcome and secondary outcomes through 7 and 45 days post-procedure were similar in the SDD and non-SDD groups. Our findings are hypothesis generating and warrant further investigation in prospective trials.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009669
Tan BE, Boppana LKT, Abdullah AS, Chuprun D, ... Bhatt DL, Depta JP
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009669 | PMID: 33423538
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Impact:
Abstract

Sex Differences in Ischemic and Bleeding Outcomes in Patients With Non-ST-Segment-Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Insights From the TAO Trial.

Dillinger JG, Ducrocq G, Elbez Y, Cohen M, ... Mehta SR, Steg PG
Background
Previous studies have observed poorer outcomes in females with myocardial infarction, but older age and lower use of percutaneous coronary intervention in females are factors that potentially explain the worse outcome. This study sought to determine if female sex is an independent factor of ischemic and bleeding outcomes in non-ST-segment-elevation acute coronary syndrome treated with a systematic invasive approach.
Methods
The TAO trial (Treatment of Acute Coronary Syndrome With Otamixaban) randomized patients with non-ST-segment-elevation acute coronary syndrome treated invasively to heparin plus eptifibatide versus otamixaban. In this post hoc analysis, the primary ischemic end point (all-cause death, myocardial infarction within 180 days) and the primary safety end point (Thrombolysis in Myocardial Infarction major or minor bleeding within 30 days) were analyzed according to sex.
Results
Of 13 229 randomized patients, 3980 (30.1%) were females and 9249 (69.9%) were males. Females were older (64.8±11.0 versus 60.7±11.1 years), had more comorbidities, received less peri-procedural antithrombotic therapy, and underwent less frequently revascularization. Overall, females experienced a higher risk of ischemic (10.2% versus 9.1%; odds ratio [OR], 1.15 [1.01-1.30]) and bleeding events (4.2% versus 3.4%; OR, 1.23 [1.02-1.49]) than males. After multivariate analysis, the risk of ischemic outcomes (OR, 1.04 [0.90-1.19]), death (OR, 1.00 [0.75-1.23]), or bleeding (OR, 1.05 [0.85-1.28]), were similar between females and males. Only, noncoronary artery bypass graft related Thrombolysis in Myocardial Infarction major bleeding were increased in females (OR, 1.69 [1.11-2.56]).
Conclusions
In patients with non-ST-segment-elevation acute coronary syndrome with systematic invasive management, ischemic outcomes, bleeding events, and mortality were higher in females. After multivariate analyses, female sex was not an independent predictor of ischemic and bleeding events although noncoronary artery bypass graft related Thrombolysis in Myocardial Infarction major bleeding was higher in females. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01076764.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009759
Dillinger JG, Ducrocq G, Elbez Y, Cohen M, ... Mehta SR, Steg PG
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009759 | PMID: 33430604
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Impact:
Abstract

Systematic Approach to High Implantation of SAPIEN-3 Valve Achieves a Lower Rate of Conduction Abnormalities Including Pacemaker Implantation.

Sammour Y, Banerjee K, Kumar A, Lak H, ... Krishnaswamy A, Kapadia S
Background
The conventional method of implanting balloon-expandable SAPIEN-3 (S3) valve results in a final 70:30 or 80:20 ratio of the valve in the aorta:left ventricular outflow tract with published rates of permanent pacemaker around 10%. We sought to evaluate whether higher implantation of S3 reduces conduction abnormalities including the need for permanent pacemaker.
Methods
We included consecutive patients who underwent transfemoral transcatheter aortic valve replacement using S3 between April 2015 and December 2018 and compared outcomes with typical valve deployment strategy to our more contemporary high deployment technique (HDT). We excluded patients with nontransfemoral access or valve-in-valve.
Results
Among 1028 patients, HDT was performed in 406 patients (39.5%). Mean implantation depth under the noncoronary cusp was significantly smaller with HDT compared with conventional technique (1.5±1.6 versus 3.2±1.9 mm; P<0.001). Successful implantation was achieved in 100% of the patients in both groups with no cases of conversion to open heart surgery, second valve implantation within the first transcatheter aortic valve replacement, or coronary occlusion during transcatheter aortic valve replacement. One patient (0.2%) had valve embolization with HDT (P=0.216). Thirty-day permanent pacemaker rates were lower with HDT (5.5% versus 13.1%; P<0.001), as were rates of complete heart block (3.5% versus 11.2%; P<0.001) and new-onset left bundle branch block (5.3% versus 12.2%; P<0.001). There were no differences in mild (16.5% versus 15.9%; P=0.804), or moderate-to-severe aortic regurgitation (1% versus 2.7%; P=0.081) at 1 year. HDT was associated with slightly higher 1-year mean gradients (13.1±6.2 versus 11.8±4.9 mm Hg; P=0.042) and peak gradients (25±11.9 versus 22.5±9 mm Hg; P=0.026). However, Doppler velocity index was similar (0.47±0.15 versus 0.48±0.13; P=0.772).
Conclusions
Our novel technique for balloon-expandable S3 valve positioning consistently achieves higher implantation resulting in substantial reduction in conduction abnormalities and permanent pacemaker requirement after transcatheter aortic valve replacement without compromising procedural safety or valve hemodynamics. Operators should consider this as an important technique to improve patient outcomes.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009407
Sammour Y, Banerjee K, Kumar A, Lak H, ... Krishnaswamy A, Kapadia S
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009407 | PMID: 33430603
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Impact:
Abstract

Calcium Modification Techniques in Complex Percutaneous Coronary Intervention.

Shah M, Najam O, Bhindi R, De Silva K
Percutaneous coronary intervention is the most common mode of revascularization and is increasingly undertaken in high-risk subsets, including the elderly. The presence of coronary artery calcification is increasingly observed and significantly limits technical success. The mechanisms for this are multi-factorial, including increased arterial wall stiffness and impaired delivery of devices, leading to suboptimal stent delivery, deployment, and expansion which are harbingers for increased risk of in-stent restenosis and stent thrombosis. Although conventional balloon pretreatment techniques aim to mitigate this risk by modifying the lesion before stent placement, many lesions remain resistant to conventional strategies, due to the severity of calcification. There have been several substantial technological advancements in calcium modification methods in recent years, which have allowed improved procedural success with low periprocedural complication rates. This review will summarize the current adjunctive modification technologies that can be employed to improve technical outcomes in percutaneous coronary intervention in calcific disease and the evidence supporting these tools.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009870
Shah M, Najam O, Bhindi R, De Silva K
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009870 | PMID: 33441017
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Impact:
Abstract

Time Delay, Infarct Size, and Microvascular Obstruction After Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction.

Redfors B, Mohebi R, Giustino G, Chen S, ... Ben-Yehuda O, Stone GW
Background
Symptom-to-balloon time (SBT) and door-to-balloon time (DBT) are both considered important metrics in patients undergoing primary percutaneous coronary intervention (pPCI) for ST-segment-elevation myocardial infarction (STEMI). We sought to assess the relationship of SBT and DBT with infarct size and microvascular obstruction (MVO) after pPCI.
Methods
Individual patient data for 3115 ST-segment-elevation myocardial infarction patients undergoing pPCI in 10 randomized trials were pooled. Infarct size (% left ventricular mass) was assessed within 1 month after randomization by technetium-99 m sestamibi single-photon emission computerized tomography (3 studies) or cardiac magnetic resonance imaging (7 studies). MVO was assessed by cardiac magnetic resonance. Patients were stratified by short (≤2 hours), intermediate (2-4 hours), or long (>4 hours) SBTs, and by short (≤45 minutes), intermediate (45-90 minutes), or long (>90 minutes) DBTs.
Results
Median [interquartile range] SBT and DBT were 185 [130-269] and 46 [28-83] minutes, respectively. Median [interquartile range] time to infarct size assessment after pPCI was 5 [3-12] days. There was a stepwise increase in infarct size according to SBT category (adjusted difference, 2.0% [95% CI, 0.4-3.5] for intermediate versus short SBT and 4.4% [95% CI, 2.7-6.1] for long versus short SBT) but not according to DBT category (adjusted difference, 0.4% [95% CI, -1.2 to 1.9] for intermediate versus short DBT and -0.1% [95% CI, -1.0 to 3.0] for long versus short SBT). MVO was greater in patients with long versus short SBT (adjusted difference, 0.9% [95% CI, 0.3-1.4]) but was not different between patients with intermediate versus short SBT (adjusted difference, 0.1 [95% CI, -0.4 to 0.6]). There was no difference in MVO according to DBT. Results were similar in multivariable analysis with SBT and DBT included as continuous variables.
Conclusions
Among 3115 patients with ST-segment-elevation myocardial infarction undergoing infarct size assessment after pPCI, SBT was more strongly correlated with infarct size and MVO than DBT.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009879
Redfors B, Mohebi R, Giustino G, Chen S, ... Ben-Yehuda O, Stone GW
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009879 | PMID: 33440999
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Impact:
Abstract

Percutaneous Implantation of Adult Sized Stents for Coarctation of the Aorta in Children ≤20 kg: A 12-Year Experience.

Boe BA, Armstrong AK, Janse SA, Loccoh EC, ... Cheatham JP, Berman DP
Background
Stent implantation (SI) is more effective than balloon angioplasty for the treatment of coarctation of the aorta (CoA). Due to technical factors, balloon angioplasty is more commonly performed in small patients. We sought to evaluate outcomes of percutaneous adult sized SI for the treatment of CoA in small patients.
Methods
A single-center retrospective review of all patients ≤20 kg who underwent percutaneous adult sized SI for native or recurrent CoA from 2004 to 2015 was performed.
Results
Thirty-nine patients (20 patients ≤10 kg) were identified, with 28 (71.8%) having recurrent CoA and 22 (56.4%) previously failed balloon angioplasty. At the time of SI, the median (range) patient age and weight were 1.1 (0.3-7.9) years and 10 (5.5-20.4) kg, respectively. SI resulted in significant improvements in the median gradient (26 mm Hg [interquartile range (IQR), 18-42] to 0 mm Hg [IQR, 0-2]; P< 0.05) and median minimum diameter (3.6 mm [IQR, 2.4-4.8] to 7.7 mm [IQR, 6.5-9.4]; P<0.05). Seven patients (18%) had procedural adverse events. Twenty-seven (69%) patients underwent elective reintervention at a median time of 49.3 (IQR, 26.5-63.2) months from SI, with 8 (21%) stents requiring repeat SI for stent fracture. Over a median follow-up of 67.2 (IQR, 33.8-116.1) months, 25 patients (69%) were without hypertension or blood pressure gradient. Three (11%) patients developed femoral arterial occlusion.
Conclusions
Adult sized SI is an alternative to surgical intervention for small patients with CoA. SI carries a risk of access-related complications, which may improve with the development of lower profile stents with adult sized maximum diameters.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009399
Boe BA, Armstrong AK, Janse SA, Loccoh EC, ... Cheatham JP, Berman DP
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009399 | PMID: 33544625
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Impact:
Abstract

Relative Impact of Clinical Risk Versus Procedural Risk on Clinical Outcomes After Percutaneous Coronary Intervention.

Kang J, Park KW, Lee HS, Zheng C, ... Koo BK, Kim HS
Background
The clinical outcome after percutaneous coronary intervention (PCI) is affected by various clinical and procedural risk factors. We investigated the relative impact of clinical and procedural risks on clinical outcomes after PCI.
Methods
A total of 13 172 patients were enrolled from the Grand-DES registry. The population was grouped into tertiles (high-, intermediate-, low-risk) according to the number of prespecified clinical and procedural risk factors, respectively. The primary end point was major adverse cardiac and cerebrovascular events (MACCE) at 3 years post-PCI.
Results
MACCE occurred in 1109 (8.4%) patients during the follow-up period (median duration: 1126 days). Compared with procedural risk, clinical risk showed superior predictive power (area under the curve: 0.678 versus 0.570, P<0.001, for clinical and procedural risks, respectively) and greater magnitude of effect in the multivariate analysis for MACCE (Clinical risk: hazard ratio, 1.953 [95% CI, 1.809-2.109], P<0.001; procedural risk: hazard ratio, 1.240 [95% CI, 1.154-1.331], P<0.001). In subgroup analyses within each clinical risk tertile, procedural risk had no significant impact on MACCE in the lowest clinical risk tertile. An annual landmark analysis revealed that clinical and procedural risks were both significant predictors of MACCE, which occurred within the first and second year post-PCI. However, for MACCE occurring in the third year post-PCI, only clinical risk but not procedural risk was a significant predictor of events.
Conclusions
Clinical and procedural risks were both significant predictors for ischemic clinical events in patients undergoing PCI. However, clinical risk had a greater and more prolonged effect on outcomes than procedural risk. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03507205.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009642
Kang J, Park KW, Lee HS, Zheng C, ... Koo BK, Kim HS
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009642 | PMID: 33541106
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Impact:
Abstract

Accuracy of Intravascular Ultrasound-Based Fractional Flow Reserve in Identifying Hemodynamic Significance of Coronary Stenosis.

Yu W, Tanigaki T, Ding D, Wu P, ... Wijns W, Tu S
Background
Ultrasonic flow ratio (UFR) is a novel method for fast computation of fractional flow reserve (FFR) from intravascular ultrasound images. The objective of this study is to evaluate the diagnostic performance of UFR using wire-based FFR as the reference.
Methods
Post hoc computation of UFR was performed in consecutive patients with both intravascular ultrasound and FFR measurement in a core lab while the analysts were blinded to FFR.
Results
A total of 167 paired comparisons between UFR and FFR from 94 patients were obtained. Median FFR was 0.80 (interquartile range, 0.68-0.89) and 50.3% had a FFR≤0.80. Median UFR was 0.81 (interquartile range, 0.69-0.91), and UFR showed strong correlation with FFR (r=0.87; P<0.001). The area under the curve was higher for UFR than intravascular ultrasound-derived minimal lumen area (0.97 versus 0.89, P<0.001). The diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio for UFR to identify FFR≤0.80 was 92% (95% CI, 87-96), 91% (95% CI, 82-96), 96% (95% CI, 90-99), 96% (95% CI, 89-99), 91% (95% CI, 93-96), 25.0 (95% CI, 8.2-76.2), and 0.10 (95% CI, 0.05-0.20), respectively. The agreement between UFR and FFR was independent of lesion locations (P=0.48), prior myocardial infarction (P=0.29), and imaging catheters (P=0.22). Intraobserver and interobserver variability of UFR analysis was 0.00±0.03 and 0.01±0.03, respectively. Median UFR analysis time was 102 (interquartile range, 87-122) seconds.
Conclusions
UFR had a strong correlation and good agreement with FFR. The fast computational time and excellent analysis reproducibility of UFR bears the potential of a wider adoption of integration of coronary imaging and physiology in the catheterization laboratory.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009840
Yu W, Tanigaki T, Ding D, Wu P, ... Wijns W, Tu S
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009840 | PMID: 33541105
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Impact:
Abstract

Short-Term Outcomes of Transcatheter Versus Isolated Surgical Aortic Valve Replacement for Mediastinal Radiation-Associated Severe Aortic Stenosis.

Nauffal V, Bay C, Shah PB, Sobieszczyk PS, ... O\'Gara P, Nohria A
Background
Surgical aortic valve replacement (SAVR) is associated with adverse outcomes in patients with radiation-associated aortic stenosis. Transcatheter aortic valve replacement (TAVR) may improve outcomes in this population.
Methods
We evaluated 1668 TAVR and 2611 patients with SAVR enrolled in the Society of Thoracic Surgeons\' database between 2011 and 2018. Multiple logistic regression was used to compare 30- day outcomes between TAVR and SAVR. Propensity-matched analysis was performed to confirm results of the overall cohort. Additionally, the cohort was stratified into early (2011-2014) versus contemporary (2015-2018) TAVR eras, and 30-day outcomes for TAVR and SAVR were compared. Finally, outcomes with transfemoral TAVR versus SAVR were compared.
Results
In the overall cohort, TAVR was associated with significantly reduced 30-day mortality (odds ratio [OR]TAVR/SAVR=0.60 [0.40-0.91]). Postoperative atrial fibrillation, pneumonia, pleural effusion, renal failure, and bleeding also occurred less frequently with TAVR. Stroke/transient ischemic attack (TIA; ORTAVR/SAVR, 2.03 [1.09-3.77]) and pacemaker implantation (ORTAVR/SAVR, 1.62 [1.21-2.17]) were higher with TAVR. Propensity-matched analysis yielded similar results as the overall cohort. Following stratification by era, TAVR versus SAVR was associated with reduced 30-day mortality in the contemporary but not early era (OREarly, 0.78 [0.48-1.28]; ORContemporary, 0.31 [0.14-0.65]). Pacemaker implantation was higher with TAVR versus SAVR in both eras (OREarly, 1.60 [1.03-2.46]; ORContemporary, 1.64 [1.10-2.45]). There was also a nonsignificant trend towards increased stroke/TIA with TAVR during both eras (OREarly, 1.39 [0.58-3.36]; ORContemporary, 2.46 [0.99-6.10]). Finally, transfemoral TAVR (N=1369) versus SAVR revealed similar findings as the overall cohort; however, the association of TAVR with stroke/TIA was not statistically significant (ORStroke/TIA, 1.57 [0.79-3.09]).
Conclusions
TAVR provides an effective and evolving alternative to SAVR for radiation-associated severe aortic stenosis and was associated with lower 30-day mortality and postoperative complications. TAVR was associated with increased pacemaker implantation and a trend towards increased stroke/TIA. In this unique population with extensive valvular and vascular calcifications, the risk of stroke/TIA with TAVR requires careful consideration and further investigation.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e010009
Nauffal V, Bay C, Shah PB, Sobieszczyk PS, ... O'Gara P, Nohria A
Circ Cardiovasc Interv: 30 Dec 2020; 14:e010009 | PMID: 33541102
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Abstract

Patient Selection and Clinical Outcomes in the STOPDAPT-2 Trial: An All-Comer Single-Center Registry During the Enrollment Period of the STOPDAPT-2 Randomized Controlled Trial.

Kanenawa K, Yamaji K, Tashiro H, Domei T, ... Watanabe H, Kimura T
Background
We sought to evaluate the impact of patient selection for the STOPDAPT-2 trial (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2) on clinical outcomes in a registry from a single center that participated in the STOPDAPT-2 trial.
Methods
Among 2190 consecutive patients who underwent percutaneous coronary intervention using stent in Kokura Memorial Hospital during the enrollment period of the STOPDAPT-2 trial, 521 patients had exclusion criteria such as in-hospital major complications, anticoagulant use, or prior intracranial bleeding (ineligible group). Among 1669 patients who met the eligibility criteria (eligible group), 582 were enrolled (enrolled group) and 1087 were not enrolled (nonenrolled group) in the STOPDAPT-2 trial. The primary outcome measure was defined as a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, stroke, or Thrombolysis in Myocardial Infarction major and minor bleeding.
Results
Compared with the enrolled group, patients in the nonenrolled group more often had high bleeding risk according to the Academic Research Consortium for High Bleeding Risk definition (52.6% versus 41.2%; P<0.001) and were frailer according to the Canadian Study of Health and Aging Clinical Frailty Scale (intermediate, 21.4% versus 14.1%; high, 6.4% versus 2.1%; P<0.001). The cumulative 1-year incidences of the primary outcome measure, all-cause death, and major bleeding were significantly higher in the nonenrolled group than in the enrolled group (7.2% versus 4.5%, P=0.03; 4.1% versus 0.9%, P<0.001; and 4.3% versus 2.1%, P=0.03, respectively) and in the ineligible group than in the eligible group (21.2% versus 6.3%, P<0.001; 9.9% versus 3.0%, P<0.001; and 13.5% versus 3.5%, P<0.001, respectively).
Conclusions
Patients who were ineligible, eligible but not enrolled, and enrolled in the STOPDAPT-2 trial had different risk profiles and clinical outcomes, suggesting important implications in applying the trial results in daily clinical practice.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e010007
Kanenawa K, Yamaji K, Tashiro H, Domei T, ... Watanabe H, Kimura T
Circ Cardiovasc Interv: 30 Dec 2020; 14:e010007 | PMID: 33541100
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Abstract

Prognostic Impact of Change in Nutritional Risk on Mortality and Heart Failure After Transcatheter Aortic Valve Replacement.

González Ferreiro R, López Otero D, Álvarez Rodríguez L, Otero García Ó, ... Cruz-González I, González Juanatey JR
Background
Limited data are available regarding change in the nutritional status after transcatheter aortic valve replacement (TAVR). This study evaluated the prognostic impact of the change in the geriatric nutritional risk index following TAVR.
Methods
TAVR patients were analyzed in a prospective and observational study. To analyze the change in nutritional status, geriatric nutritional risk index of the patients was calculated on the day of TAVR and at 3-month follow-up. The impact of the change in nutritional risk index after TAVR on all-cause mortality, heart failure hospitalization (HF-h), and the composite of all-cause death and HF hospitalization was analyzed using the Cox Proportional Hazards model.
Results
Four hundred thirty-three patients were included. After TAVR, 68.4% (n=182) patients with baseline nutritional risk improved compared with 31.6% (n=84) who remained at nutritional risk. The change from no-nutritional risk to nutritional risk after TAVR occurred in 15.0% (n=25), while 85.0% (n=142) remained without risk of malnutrition. During follow-up, 157 (36.3%) patients died and 172 patients (39.7%) were hospitalized due to HF. Patients who continued to be at nutritional risk had a higher risk of mortality (hazard ratio [HR], 2.10 [95% CI, 1.30-3.39], P=0.002), HF-h (HR, 1.97 [95% CI, 1.26-3.06], P=0.000), and the composite of death and HF-h (HR, 2.0 [95% CI, 1.37-2.91], P<0.001). The change to non-nutritional risk after TAVR significantly impacted mortality (HR, 0.48 [95% CI, 0.30-0.78], P=0.003), HF-h (HR, 0.50 [95% CI, 0.34-0.74], P=0.001), and the composite outcome (HR, 0.44 [95% CI, 0.32-0.62], P<0.001).
Conclusions
Remaining at nutritional risk after TAVR confers a poor prognosis and is associated with an increased risk of mortality and HF-h, while the change from risk of malnutrition to non-nutritional risk after TAVR was associated with a halving of the risk of mortality and HF-h. Further studies are needed to identify whether patients at nutritional risk would benefit from nutritional intervention during processes of care of TAVR programs.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009342
González Ferreiro R, López Otero D, Álvarez Rodríguez L, Otero García Ó, ... Cruz-González I, González Juanatey JR
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009342 | PMID: 33541099
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Abstract

Therapeutic Approaches for the No-Option Refractory Angina Patient.

Povsic TJ, Henry TD, Ohman EM
The combination of an aging population and improved survival rates among patients with coronary artery disease has resulted in an increase in the number of patients with refractory angina or anginal equivalent symptoms despite maximal medical therapy. Patients with refractory angina are often referred to the cardiac catheterization laboratory; however, they have often exhausted conventional revascularization options; thus, this population is often deemed as having \"no options.\" We review the definition, prevalence, outcomes, therapeutic options, and treatment considerations for no-option refractory angina patients and focus on novel therapies for this complex and challenging population. We propose a multidisciplinary team approach for the evaluation and management of patients with refractory angina, ideally in a designated clinic. The severe limitations and symptomatology experienced by these patients highlight the need for additional research into the development of innovative treatments.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009002
Povsic TJ, Henry TD, Ohman EM
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009002 | PMID: 33541098
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Abstract

Transcatheter Tricuspid Valve Intervention in Patients With Right Ventricular Dysfunction or Pulmonary Hypertension: Insights From the TriValve Registry.

Muntané-Carol G, Taramasso M, Miura M, Gavazzoni M, ... Hahn RT, Rodés-Cabau J
Background
Scarce data exist on patients with right ventricular dysfunction (RVD) or pulmonary hypertension (PH) undergoing transcatheter tricuspid valve intervention. This study aimed to determine the early and midterm outcomes and the factors associated with mortality in this group of patients.
Methods
This subanalysis of the multicenter TriValve (Transcatheter Tricuspid Valve Therapies) registry included 300 patients with severe tricuspid regurgitation with RVD (n=244), PH (n=127), or both (n=71) undergoing transcatheter tricuspid valve intervention. RVD was defined as a tricuspid annular plane systolic excursion <17 mm, and PH as an estimated pulmonary artery systolic pressure ≥50 mm Hg.
Results
Mean age of the patients was 77±9 years (54% women). Procedural success was 80.7%, and 9 patients (3%) died during the hospitalization. At a median follow-up of 6 (interquartile range, 2-12) months, 54 patients (18%) died, and the independent associated factors were higher gamma-glutamyl transferase values at baseline (hazard ratio, 1.02 for each increase of 10 u/L [95% CI, 1.002-1.04]), poorer renal function defined as an estimated glomerular filtration rate <45 mL/min (hazard ratio, 2.3 [95% CI, 1.22-4.33]), and the lack of procedural success (hazard ratio, 2.11 [95% CI, 1.17-3.81]). The grade of RVD and the amount of PH at baseline were not found to be predictors of mortality. Most patients alive at follow-up improved their functional class (New York Heart Association I-II in 66% versus 7% at baseline, P<0.001).
Conclusions
In patients with severe tricuspid regurgitation and RVD/PH, transcatheter tricuspid valve intervention was associated with high procedural success and a relatively low in-hospital mortality, along with significant improvements in functional status. However, about 1 out of 5 patients died after a median follow-up of 6 months, with hepatic congestion, renal dysfunction, and the lack of procedural success determining an increased risk. These results may improve the clinical evaluation of transcatheter tricuspid valve intervention candidates and would suggest a closer follow-up in those at increased risk. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03416166.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009685
Muntané-Carol G, Taramasso M, Miura M, Gavazzoni M, ... Hahn RT, Rodés-Cabau J
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009685 | PMID: 33541097
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Abstract

Risk Stratification Guided by the Index of Microcirculatory Resistance and Left Ventricular End-Diastolic Pressure in Acute Myocardial Infarction.

Maznyczka AM, McCartney PJ, Oldroyd KG, Lindsay M, ... McConnachie A, Berry C
Background
The index of microcirculatory resistance (IMR) of the infarct-related artery and left ventricular end-diastolic pressure (LVEDP) are acute, prognostic biomarkers in patients undergoing primary percutaneous coronary intervention. The clinical significance of IMR and LVEDP in combination is unknown.
Methods
IMR and LVEDP were prospectively measured in a prespecified substudy of the T-TIME clinical trial (Trial of Low Dose Adjunctive Alteplase During Primary PCI). IMR was measured using a pressure- and temperature-sensing guidewire following percutaneous coronary intervention. Prognostically established thresholds for IMR (>32) and LVEDP (>18 mm Hg) were predefined. Contrast-enhanced cardiovascular magnetic resonance imaging (1.5 Tesla) was acquired 2 to 7 days and 3 months postmyocardial infarction. The primary end point was major adverse cardiac events, defined as cardiac death/nonfatal myocardial infarction/heart failure hospitalization at 1 year.
Results
IMR and LVEDP were both measured in 131 patients (mean age 59±10.7 years, 103 [78.6%] male, 48 [36.6%] with anterior myocardial infarction). The median IMR was 29 (interquartile range, 17-55), the median LVEDP was 17 mm Hg (interquartile range, 12-21), and the correlation between them was not statistically significant (r=0.15; P=0.087). Fifty-three patients (40%) had low IMR (≤32) and low LVEDP (≤18), 18 (14%) had low IMR and high LVEDP, 31 (24%) had high IMR and low LVEDP, while 29 (22%) had high IMR and high LVEDP. Infarct size (% LV mass), LV ejection fraction, final myocardial perfusion grade ≤1, TIMI (Thrombolysis In Myocardial Infarction) flow grade ≤2, and coronary flow reserve were associated with LVEDP/IMR group, as was hospitalization for heart failure (n=18 events; P=0.045) and major adverse cardiac events (n=21 events; P=0.051). LVEDP>18 and IMR>32 combined was associated with major adverse cardiac events, independent of age, estimated glomerular filtration rate, and infarct-related artery (odds ratio, 5.80 [95% CI, 1.60-21.22] P=0.008). The net reclassification improvement for detecting major adverse cardiac events was 50.6% (95% CI, 2.7-98.2; P=0.033) when LVEDP>18 was added to IMR>32.
Conclusions
IMR and LVEDP in combination have incremental value for risk stratification following primary percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02257294.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009529
Maznyczka AM, McCartney PJ, Oldroyd KG, Lindsay M, ... McConnachie A, Berry C
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009529 | PMID: 33591821
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Abstract

Left Main Trifurcation and Its Percutaneous Treatment: What Is Known So Far?

Kovacevic M, Burzotta F, Elharty S, Besis G, ... Romagnoli E, Trani C
In humans, the most common anatomic variation of the left main (LM) stem is represented by its distal division in 3 branches (LM trifurcation) instead of 2. LM trifurcation disease accounts for ≈10% to 15% of all LM diseases and is often managed by cardiac surgery. Over the last decades, due to the improvement of interventional material and techniques, percutaneous coronary intervention started gaining acceptance to treat patients with LM disease including those with trifurcated anatomy. Yet, LM trifurcation stenosis with its intrinsic anatomic complexity (3 branches, at least 4 angles, wide variability in branch size and disease) is recognized as a challenging lesion subset for percutaneous coronary intervention. In this review, we summarize available data about LM trifurcation anatomy, its influence on percutaneous coronary intervention feasibility, and the evidence collected regarding the different technical options (including trissing balloon inflation).



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009872
Kovacevic M, Burzotta F, Elharty S, Besis G, ... Romagnoli E, Trani C
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009872 | PMID: 33685210
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Abstract

Surgical Explantation of Transcatheter Aortic Valve Bioprostheses: A Statewide Experience.

Brescia AA, Deeb GM, Sang SLW, Tanaka D, ... Fukuhara S, Michigan Society of Thoracic and Cardiovascular Surgeons and the Blue Cross Blue Shield of Michigan Cardiovascular Consortium
Background
Despite the rapid adoption of transcatheter aortic valve replacement (TAVR) since its initial approval in 2011, the frequency and outcomes of surgical explantation of TAVR devices (TAVR-explant) is poorly understood.
Methods
Patients undergoing TAVR-explant between January 2012 and June 2020 at 33 hospitals in Michigan were identified in the Society of Thoracic Surgeons Database and linked to index TAVR data from the Transcatheter Valve Therapy Registry through a statewide quality collaborative. The primary outcome was operative mortality. Indications for TAVR-explant, contraindications to redo TAVR, operative data, and outcomes were collected from Society of Thoracic Surgeons and Transcatheter Valve Therapy databases. Baseline Society of Thoracic Surgeons Predicted Risk of Mortality was compared between index TAVR and TAVR-explant.
Results
Twenty-four surgeons at 12 hospitals performed TAVR-explants in 46 patients (median age, 73). The frequency of TAVR-explant was 0.4%, and the number of explants increased annually. Median time to TAVR-explant was 139 days and among known device types explanted, most were self-expanding valves (29/41, 71%). Common indications for TAVR-explant were procedure-related failure (35%), paravalvular leak (28%), and need for other cardiac surgery (26%). Contraindications to redo TAVR included need for other cardiac surgery (28%), unsuitable noncoronary anatomy (13%), coronary obstruction (11%), and endocarditis (11%). Overall, 65% (30/46) of patients underwent concomitant procedures, including aortic repair/replacement in 33% (n=15), mitral surgery in 22% (n=10), and coronary artery bypass grafting in 16% (n=7). The median Society of Thoracic Surgeons Predicted Risk of Mortality was 4.2% at index TAVR and 9.3% at TAVR-explant (P=0.001). Operative mortality was 20% (9/46) and 76% (35/46) of patients had in-hospital complications. Of patients alive at discharge, 37% (17/37) were discharged home and overall 3-month survival was 73±14%.
Conclusions
TAVR-explant is rare but increasing, and its clinical impact is substantial. As the utilization of TAVR expands into younger and lower-risk patients, providers should consider the potential for future TAVR-explant during selection of an initial valve strategy.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009927
Brescia AA, Deeb GM, Sang SLW, Tanaka D, ... Fukuhara S, Michigan Society of Thoracic and Cardiovascular Surgeons and the Blue Cross Blue Shield of Michigan Cardiovascular Consortium
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009927 | PMID: 33719506
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Abstract

Implications of Atrial Fibrillation on the Mechanisms of Mitral Regurgitation and Response to MitraClip in the COAPT Trial.

Gertz ZM, Herrmann HC, Lim DS, Kar S, ... Stone GW, Mack MJ
Background
Atrial fibrillation (AF), mitral regurgitation (MR), and left ventricular (LV) ejection fraction have a complex interplay. We evaluated the role of AF in patients with heart failure and moderate-to-severe or severe secondary MR enrolled in the randomized COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) and its impact on mechanisms and outcomes with the MitraClip.
Methods
Patients in the COAPT trial were stratified by the presence (n=327) or absence (n=287) of a history of AF and by assignment to treatment group. Clinical, echocardiographic, and outcome measures were assessed. The primary outcome was the composite rate of death or heart failure hospitalization at 24 months.
Results
Patients with history of AF were older and more often male. They had a higher LV ejection fraction, larger left atrial volumes and mitral valve orifice areas, smaller LV volumes, and similar MR severity. Patients with AF compared with those without a history of AF had a higher unadjusted (hazard ratio [HR], 1.32 [95% CI, 1.06–1.64], P=0.01) and adjusted (HR, 1.30 [1.03–1.64], P=0.03) 2-year rate of the primary outcome. Treatment with the MitraClip compared with guideline-directed medical therapy alone reduced death or heart failure hospitalization in both those with (HR, 0.61 [0.46–0.82]) and without (HR, 0.46 [0.33–0.66]) a history of AF (Pint=0.18). Treatment with the MitraClip was associated with a lower risk of stroke in patients with a history of AF (HR, 0.18 [0.04–0.86]) but not in those without a history of AF (HR, 1.64 [0.58–4.62]; Pint=0.02).
Conclusions
In the COAPT trial, patients with a history of AF had larger left atrial and mitral valve orifice areas with higher LV ejection fraction and smaller LV volumes, suggesting an atrial mechanism contribution to functional MR. Despite the worse prognosis of heart failure patients with a history of AF, MR reduction with the MitraClip still afforded substantial clinical benefits. Treatment with MitraClip was associated with a lower risk of stroke in patients with a history of AF.
Registration
URL: https://www.clinicaltrials.gov; Unique identifier: NCT01626079.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e010300
Gertz ZM, Herrmann HC, Lim DS, Kar S, ... Stone GW, Mack MJ
Circ Cardiovasc Interv: 30 Dec 2020; 14:e010300 | PMID: 33719505
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Abstract

Mid-Term Outcomes Following Percutaneous Pulmonary Valve Implantation Using the \"Folded Melody Valve\" Technique.

Jalal Z, Valdeolmillos E, Malekzadeh-Milani S, Eicken A, ... Thambo JB, Boudjemline Y
Background
The folded valve is a manual shortening of the Melody device, which has been validated as a valuable therapeutic option for the management of dysfunctional right ventricular outflow tracts needing a short valved stent. In this article, we aimed to evaluate, in a multicenter cohort, the mid-term outcomes of patients in whom a percutaneous pulmonary valve implantation was performed using the folded valve technique.
Methods
A 2012 to 2018 retrospective multicenter study was performed in 7 European institutions. All patients who benefit from percutaneous pulmonary valve implantation with a folded Melody valve were included.
Results
A total of 49 patients (median age, 19 years [range 4–56], 63% male) were included. The primary percutaneous pulmonary valve implantation indication was right ventricular outflow tract stenosis (n=19; 39%), patched native right ventricular outflow tracts were the most common substrate (n=15; 31%). The folded technique was mostly used in short right ventricular outflow tracts (n=28; 57%). Procedural success was 100%. After a median follow-up of 28 months (range, 4–80), folded Melody valve function was comparable to the immediate postimplantation period (mean transvalvular peak velocity=2.6±0.6 versus 2.4±0.6 m/s, P>0.1; only 2 patients had mild pulmonary regurgitation). Incidence rate of valve-related reinterventions was 2.1% per person per year (95% CI, 0.1%–3.9%). The probability of survival without valve-related reinterventions at 36 months was 90% (95% CI, 76%–100%).
Conclusions
The folded Melody valve is a safe technique with favorable mid-term outcomes up to 6.5 years after implantation, comparable with the usual Melody valve implantation procedure. Complications and reinterventions rates were low, making this technique relevant in selected patients.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009707
Jalal Z, Valdeolmillos E, Malekzadeh-Milani S, Eicken A, ... Thambo JB, Boudjemline Y
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009707 | PMID: 33726503
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Impact:
Abstract

Variation in Antithrombotic Therapy and Clinical Outcomes in Patients With Preexisting Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

Sherwood MW, Gupta A, Vemulapalli S, Li Z, ... Kirtane AJ, Peterson ED
Background
Optimal antithrombotic management of patients with preexisting atrial fibrillation undergoing transcatheter aortic valve replacement is challenging given the need to balance the risk of bleeding and thromboembolism. We aimed to examine variation in care and association of antithrombotic therapies with 1-year outcomes of stroke, bleeding, and mortality in patients undergoing transcatheter aortic valve replacement with concomitant atrial fibrillation in the United States.
Methods
Patients who underwent transcatheter aortic valve replacement with preexisting atrial fibrillation from November 2011 through September 2015 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry linked to the Medicare database were examined according to receipt of oral anticoagulants (OACs) or antiplatelet therapies (APTs) or a combination of these (OAC+APT) at discharge. To assess the associations of antithrombotic therapies with 1-year outcomes of stroke, bleeding, and mortality, we utilized inverse probability weighting for antithrombotic therapies and multivariable regression modeling to adjust for patient- and hospital-level variables.
Results
In the 11 382 patients included in our study, 5833 (51.2%) were discharged on OAC+APT, 4786 (42.0%) on APT alone, and 763 (6.7%) on OAC alone. There was significant variability in discharge medication patterns, including 42% of patients discharged without OAC therapy. In adjusted analyses, the risk for all-cause mortality and stroke was not significantly different when comparing the 3 different antithrombotic strategies. Risk of bleeding was higher with OAC+APT compared with APT alone (hazard ratio, 1.16 [95% CI, 1.05–1.27]) and similar compared with OAC alone (hazard ratio, 1.17 [95% CI, 0.93–1.47]).
Conclusions
There was significant variability in discharge medication patterns across US sites in patients with atrial fibrillation undergoing transcatheter aortic valve replacement, including significant underuse of OAC in this high-risk cohort. The use of OAC+APT (versus OAC alone or APT alone) was not associated with a lower risk of stroke or mortality but was associated with increased risk of bleeding complications at 1 year compared with APT alone.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009963
Sherwood MW, Gupta A, Vemulapalli S, Li Z, ... Kirtane AJ, Peterson ED
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009963 | PMID: 33877866
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Abstract

Pregnancy in the Cardiac Catheterization Laboratory: A Safe and Feasible Endeavor.

Cheney AE, Vincent LL, McCabe JM, Kearney KE
Concerns over radiation exposure are ubiquitous to all interventional cardiologists; however, fear of exposure during childbearing years disproportionately deters women from entering the field. This review summarizes the available data on occupational radiation exposure during pregnancy with an emphasis on radiation quantification, the impact of exposure at various stages of fetal development, societal recommendations for safe levels of exposure during gestation, threshold levels necessary to induce fetal harm, and safe practices for the pregnant interventionalist. Reconciling the available information, we conclude that pregnancy in the cardiac catheterization laboratory is both safe and feasible. This review also highlights new technologies that may augment standard radiation safety techniques and are of particular interest to the pregnant interventional cardiologist. Finally, we propose steps to improve female representation in this field, underscoring the importance of a sex-balanced workforce.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009636
Cheney AE, Vincent LL, McCabe JM, Kearney KE
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009636 | PMID: 33877865
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Impact:
Abstract

BASILICA Trial: One-Year Outcomes of Transcatheter Electrosurgical Leaflet Laceration to Prevent TAVR Coronary Obstruction.

Khan JM, Greenbaum AB, Babaliaros VC, Dvir D, ... Rogers T, Lederman RJ
Background
Coronary artery obstruction is a rare, devastating complication of transcatheter aortic valve replacement. Transcatheter electrosurgical aortic leaflet laceration (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction [BASILICA]) is a novel technique to prevent coronary artery obstruction. We report the 1-year outcomes of the BASILICA trial. Primary end points of 30-day success and safety have been reported previously.
Methods
The BASILICA trial was a prospective, multicenter, single-arm safety and feasibility study. Subjects with severe native or bioprosthetic aortic valve disease at high or extreme risk for surgery, and high risk of coronary artery obstruction, were included. End points at 1 year included death, stroke, and myocardial infarction. Source data was independently verified and end points independently adjudicated.
Results
Thirty subjects were enrolled between February 2018 and July 2018. At 30 days, BASILICA was successful in 28 subjects (93.3%), there were 3 strokes (10%), including 1 disabling stroke (3.3%), 1 death (3.3%), and 1 periprocedural myocardial infarction (3.3%). Between 30 days and 1 year, there were no additional strokes, no myocardial infarction, and 2 deaths (10% 1-year mortality). No subject needed repeat intervention for aortic valve or coronary disease. Two subjects had infective endocarditis (6.7%), but neither was isolated to the aortic valve. There were no hospital admissions for heart failure. Fourteen (46.7%) subjects required repeat hospital admission for other causes. Aortic valve gradients on echocardiography, New York Heart Association functional class, and Kansas City Cardiomyopathy Questionnaire scores improved from baseline to 30 days and were maintained at 1 year.
Conclusions
In these subjects with multiple comorbidities and restrictive anatomy that underwent transcatheter aortic valve replacement, there was no late stroke, myocardial infarction, or death related to BASILICA. Mitigation of coronary obstruction remained intact at 1 year and was not related to recurrent readmission. These results are reassuring for patients and physicians who wish to avoid the long-term complications related to snorkel stenting.
Registration
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03381989.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e010238
Khan JM, Greenbaum AB, Babaliaros VC, Dvir D, ... Rogers T, Lederman RJ
Circ Cardiovasc Interv: 30 Dec 2020; 14:e010238 | PMID: 34003670
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Abstract

Colchicine to Prevent Periprocedural Myocardial Injury in Percutaneous Coronary Intervention: The COPE-PCI Pilot Trial.

Cole J, Htun N, Lew R, Freilich M, Quinn S, Layland J
Background
Periprocedural myocardial infarction and injury (PM-injury) are the most common complications of percutaneous coronary intervention (PCI) and are associated with future adverse cardiac events. Inflammation plays a pivotal role in the development of PM-injury. In this randomized pilot trial, we assessed the effect of an anti-inflammatory medication colchicine on periprocedural myocardial injury.
Methods
Patients undergoing PCI for stable angina or non–ST-segment–elevation myocardial infarction were randomized to oral colchicine (1 mg followed by 0.5 mg 1 hour later) or placebo, 6 to 24 hours preprocedure. Blood samples were taken immediately pre- and 24-hours post-PCI. The primary outcome, periprocedural myocardial infarction, was defined by an increase in post-PCI troponin >5×99th% upper reference limit when the pre-PCI troponin was normal, or >20% increase in post-PCI troponin when the pre-PCI troponin was raised, including supporting evidence of new myocardial ischemia. Major PM-injury was defined as per periprocedural myocardial infarction without supporting evidence of new myocardial ischemia. Minor PM-injury was defined by post-PCI troponin increase >99th% upper reference limit but ≤5×99th% upper reference limit.
Results
A total of 196 patients met inclusion criteria and were randomized. One hundred twenty-one patients were excluded (no PCI, unstable troponin before PCI, or poor-quality measurements) leaving a study population of 75 patients. Thirty-six patients were randomized to colchicine and 39 to placebo preprocedure. Forty-four presented with non–ST-segment–elevation myocardial infarction and 31 with stable angina. High-sensitive (hs) troponin-I pre-PCI was similar between treatment groups (colchicine: 79 ng/L [4–1336] versus placebo: 35 [5–448], P=0.42). Absolute change in hs-troponin-I (calculated as 24-hour post-PCI minus pre-PCI measurements) was significantly lower in the colchicine group: 59 (1–221) versus placebo: 166 (53–530), P=0.02. No patients developed periprocedural myocardial infarction in either group. Significantly fewer patients developed major PM-injury: 11 (31%) versus 21 (54%), P=0.04 or minor PM-injury: 21 (58%) versus 33 (85%), P=0.01, if given colchicine pre-PCI.
Conclusions
In this randomized pilot trial, colchicine given 6 to 24 hours pre-PCI reduces periprocedural myocardial injury.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009992
Cole J, Htun N, Lew R, Freilich M, Quinn S, Layland J
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009992 | PMID: 34003667
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Impact:
Abstract

Valve-in-Surgical-Valve With SAPIEN 3 for Transcatheter Aortic Valve Replacement Based on Society of Thoracic Surgeons Predicted Risk of Mortality.

Kaneko T, Makkar RR, Krishnaswami A, Hermiller J, ... Kapadia S, Abbas AE
Background
The use of valve-in-valve–transcatheter aortic valve replacement (VIV-TAVR) in degenerated aortic bioprosthesis has been increasing, but the Food and Drug Administration approval is limited to high-risk patients. We analyzed the real-world experience of SAPIEN 3 VIV-TAVR, especially in lower-risk patients, based on the Society of Thoracic Surgeons (STS) score.
Methods
All transfemoral VIV-TAVR with the SAPIEN 3 and Ultra valves between June 2015 and January 2020 were identified using the STS/American College of Cardiology Transcatheter Valve Therapies Registry. Patients were grouped based on STS score (low score: <4%, intermediate score: 4%≤ and≤8%, high score: >8%). Propensity-matched (1:3) analysis was conducted to compare to patients undergoing native TAVR.
Results
Of 145 917 SAPIEN 3 TAVR patients, 4460 (3%) underwent transfemoral VIV-TAVR with available baseline STS data in 4276 patients. Average age was 73.9±11.2, 66.4% were male, and the mean STS score was 6.9±6.0%. Overall 30-day mortality was 2.4% (observed to expected ratio, 0.33), and 1-year mortality was 10.8%. 30-day mortality and observed to expected ratio were 0.9% and 0.32 in low-score, 2.2% and 0.38 in the intermediate-score, and 4.3% and 0.31 in the high-score group. Based on propensity-matched analysis, 30-day mortality was similar and 1-year mortality was lower in VIV compared to native TAVR among all risk groups. When the groups were analyzed based on the Heart Team risk stratification using high-risk and non–high risk, the findings remained consistent.
Conclusions
In this real-world study, VIV-TAVR had excellent 30-day and 1-year outcomes, especially in lower-risk patients. These findings may suggest the feasibility and expansion of VIV-TAVR in lower-risk patients. However, long-term follow-up continues to be crucial.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e010288
Kaneko T, Makkar RR, Krishnaswami A, Hermiller J, ... Kapadia S, Abbas AE
Circ Cardiovasc Interv: 30 Dec 2020; 14:e010288 | PMID: 34003666
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Abstract

Aspirin Versus Clopidogrel as Single Antithrombotic Therapy After Transcatheter Aortic Valve Replacement: Insight From the OCEAN-TAVI Registry.

Kobari Y, Inohara T, Saito T, Yoshijima N, ... Yamamoto M, Hayashida K
Background
Current guidelines recommend dual antiplatelet therapy for the first 1 to 6 months after transcatheter aortic valve replacement (TAVR); however, recent studies have reported better outcomes with single antiplatelet therapy than with dual antiplatelet therapy in the occurrence of bleeding events, while not increasing thrombotic events. However, no data exist about optimal single antiplatelet therapy following TAVR.
Methods
Patients who underwent TAVR between October 2013 and May 2017 were enrolled from the OCEAN-TAVI Japanese multicenter registry (Optimized Transcatheter Valvular Intervention). After excluding 1759 patients, 829 who received aspirin (100 mg/d) or clopidogrel (75 mg/d) after TAVR were identified and stratified according to the presence or absence of anticoagulation. Propensity score matching was performed to adjust the baseline characteristics between the aspirin and clopidogrel groups. Outcomes of interest were all-cause and cardiovascular deaths, stroke, and life-threatening or major bleeding within 2 years following TAVR.
Results
After propensity score matching, 98 and 157 pairs of patients without and with anticoagulation, respectively, were identified. Falsification end points of pneumonia, urinary tract infection, and hip fracture were evaluated, and their rates were not different between groups. All-cause deaths were not statistically different between the groups in patients with (aspirin, 17.5%; clopidogrel, 11.1%; log-rank P=0.07) and without (aspirin, 29.6%; clopidogrel, 20.1%; log-rank P=0.15) anticoagulation at 2 years post-TAVR, whereas clopidogrel was associated with a lower cardiovascular mortality at 2 years in patients with (aspirin, 8.5%; clopidogrel, 2.7%; log-rank P=0.03) and without (aspirin, 18.0%; clopidogrel, 5.2%; log-rank P=0.02) anticoagulation.
Conclusions
We demonstrated that clopidogrel monotherapy was associated with a lower incidence of cardiovascular death compared with aspirin monotherapy during the 2-year follow-up after TAVR regardless of anticoagulation use.
Registration
URL: https://upload.umin.ac.jp; Unique identifier: UMIN000020423.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e010097
Kobari Y, Inohara T, Saito T, Yoshijima N, ... Yamamoto M, Hayashida K
Circ Cardiovasc Interv: 30 Dec 2020; 14:e010097 | PMID: 34003663
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Abstract

Very Short Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Patients Who Underwent Complex Percutaneous Coronary Intervention: Insight From the STOPDAPT-2 Trial.

Yamamoto K, Watanabe H, Morimoto T, Domei T, ... Kimura T, STOPDAPT-2 Investigators
Background
Safety and efficacy of clopidogrel monotherapy after very short dual antiplatelet therapy (DAPT) is uncertain in patients undergoing complex percutaneous coronary intervention (PCI).
Methods
We conducted a post hoc subgroup analysis based on the complexity of PCI in the STOPDAPT-2 trial (Short and Optimal Duration of Dual Antiplatelet Therapy-2), which randomly compared 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT after cobalt-chromium everolimus-eluting stent implantation. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents, >60 mm total stent lengths, and target of chronic total occlusion. The primary end point was the composite of cardiovascular (cardiovascular death/myocardial infarction/definite stent thrombosis/stroke) and bleeding (TIMI [Thrombolysis in Myocardial Infarction] major/minor) end points. The major secondary end points were the cardiovascular and bleeding end points.
Results
Among the 3009 study patients, there were 509 patients (16.9%) with complex PCI (1-month DAPT: N=245, and 12-month DAPT: N=264) and 2500 patients (83.1%) without complex PCI (1-month DAPT: N=1255, and 12-month DAPT: N=1245). There were no significant interactions between the complexity of PCI and the effects of 1-month DAPT versus 12-month DAPT on the primary end point (complex PCI: 1.67% versus 5.32%, hazard ratio, 0.30 [95% CI, 0.10–0.92], P=0.04, and noncomplex PCI: 2.50% versus 3.35%, hazard ratio, 0.75 [95% CI, 0.47–1.20], P=0.23; Pinteraction=0.14), and on the major secondary cardiovascular end point (complex PCI: 1.67% versus 3.04%, hazard ratio, 0.54 [95% CI, 0.16–1.79], P=0.31, and noncomplex PCI: 2.02% versus 2.39%, hazard ratio, 0.86 [95% CI, 0.50–1.47], P=0.58; Pinteraction=0.49). The cumulative 1-year incidence of the major secondary bleeding end point was significantly lower in the 1-month DAPT group than in the 12-month DAPT group regardless of the complexity of PCI (complex PCI: 0% versus 2.29%, log-rank P=0.02, and noncomplex PCI: 0.48% versus 1.38%, log-rank P=0.02).
Conclusions
The effects of clopidogrel monotherapy after 1-month DAPT relative to 12-month DAPT for the primary and major secondary end points were comparable in complex PCI and noncomplex PCI without significant interactions.
Registration
URL: https://www.clinicaltrials.gov; Unique identifier: NCT02619760.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e010384
Yamamoto K, Watanabe H, Morimoto T, Domei T, ... Kimura T, STOPDAPT-2 Investigators
Circ Cardiovasc Interv: 30 Dec 2020; 14:e010384 | PMID: 34003662
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Abstract

Device-Related Thrombus After Left Atrial Appendage Closure: Data on Thrombus Characteristics, Treatment Strategies, and Clinical Outcomes From the EUROC-DRT-Registry.

Sedaghat A, Vij V, Al-Kassou B, Gloekler S, ... Rodes-Cabau J, Nickenig G
Background
Left atrial appendage closure is an established therapy in patients with atrial fibrillation. Although device-related thrombosis (DRT) is relatively rare, it is potentially linked to adverse events. As data on DRT characteristics, outcome, and treatment regimen are scarce, we aimed to assess these questions in a multicenter approach.
Methods
One hundred fifty-six patients with the diagnosis of DRT after left atrial appendage closure were included in the multinational EUROC-DRT registry. Baseline characteristics included clinical and echocardiographic data. After inclusion, all patients underwent further clinical and echocardiographic follow-up to assess DRT dynamics, treatment success, and outcome.
Results
DRT was detected after a median of 93 days (interquartile range, 54–161 days) with 17.9% being detected >6 months after left atrial appendage closure. Patients with DRT were at high ischemic and bleeding risk (CHA2DS2-VASc 4.5±1.7, HAS-BLED 3.3±1.2) and had nonparoxysmal atrial fibrillation (67.3%), previous stroke (53.8%), and spontaneous echo contrast (50.6%). The initial treatment regimens showed comparable resolution rates (antiplatelet monotherapy: 57.1%, dual antiplatelet therapy: 85.7%, vitamin K antagonists: 80.0%, novel oral anticoagulants: 75.0%, and heparin: 68.6%). After intensification or switch of treatment, complete DRT resolution was achieved in 79.5% of patients. Two-year follow-up revealed a high risk of mortality (20.0%) and ischemic stroke (13.8%) in patients with DRT. Patients with incomplete DRT resolution showed numerically higher stroke rates and increased mortality rates (stroke: 17.6% versus 12.3%, P=0.29; mortality: 31.3% versus 13.1%, P=0.05).
Conclusions
A substantial proportion of DRT is detected >6 months after left atrial appendage closure, highlighting the need for imaging follow-up. Patients with DRT appear to be at a high risk for stroke and mortality. While DRT resolution was achieved in most patients, incomplete DRT resolution appeared to identify patients at even higher risk. Optimal DRT diagnostic criteria and treatment regimens are warranted.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e010195
Sedaghat A, Vij V, Al-Kassou B, Gloekler S, ... Rodes-Cabau J, Nickenig G
Circ Cardiovasc Interv: 30 Dec 2020; 14:e010195 | PMID: 34003661
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Abstract

Long-Term Outcomes of the Coarctation of the Aorta Stent Trials.

Holzer RJ, Gauvreau K, McEnaney K, Watanabe H, Ringel R
Background
Long-term outcome data of stent-implantation for coarctation of the aorta are limited. We report up to 5 years of postimplant follow-up in patients enrolled into the COAST (Coarctation of the Aorta Stent Trial) and the COAST II trial (Covered Cheatham-Platinum Stents for Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta), evaluating the bare and Covered Cheatham-Platinum Stents for the treatment of coarctation of the aorta and associated aortic wall injury.
Methods
Data was prospectively collected during the 2 multi-center studies, enrolling 248 patients (COAST: n=121, COAST II: n=127). Late follow-up data (48–60 month) was compared with immediate (1 month) and early (12 months) follow-up.
Results
There was a notable decrease in the use of antihypertensive medication, from 53% at immediate, to 42% at early, and 29% at late follow-up. The cumulative incidence of stent fractures was 0% immediately, 2.9% at early, and 24.4% at late follow-up. Independent predictors for stent fractures at late follow-up were age <18 years, male sex, minimum stent diameter ≥12 mm, and use of bare metal stent. The cumulative incidence of reintervention was 1.6% at immediate, 5.1% at early, and 21.3% at late follow-up. Independent predictors for reinterventions at late follow-up were age <18 years, post implantation systolic arm-leg blood pressure gradient ≥10 mm Hg, minimum stent diameter at implantation <12 mm, and initial coarctation minimum diameter <6 mm. There were 13 patients with aortic aneurysms, with a cumulative incidence of 6.3% at late follow-up.
Conclusions
Coarctation stenting is effective at maintaining obstruction relief up to 60 months postimplant with reduction in the number of patients requiring antihypertensive medication. However, an increase in-stent fractures and reinterventions were observed between medium and long-term follow-up. Covered stents appear to confer some protection from the development of stent fractures but do not provide complete protection from late aneurysm formation.
Registration
URL: https://www.clinicaltrials.gov; Unique identifiers: NCT00552812 and NCT01278303.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e010308
Holzer RJ, Gauvreau K, McEnaney K, Watanabe H, Ringel R
Circ Cardiovasc Interv: 30 Dec 2020; 14:e010308 | PMID: 34039015
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Abstract

Coronary Artery Disease Evaluation and Management Considerations for High Risk Occupations: Commercial Vehicle Drivers and Pilots.

Sutton NR, Banerjee S, Cooper MM, Arbab-Zadeh A, ... Rao SV, Blumenthal RS
Optimal treatment of stable ischemic heart disease for those in the transportation industry is considered in the context of the individual\'s health, as well as with the perspective that sudden impairment could have catastrophic consequences for others. This article focuses on two high risk occupations that one may encounter in practice: commercial motor vehicle drivers and commercial pilots. This article discusses coronary heart disease in patients in high risk occupations and covers current guideline recommendations for screening, treatment, and secondary prevention. The importance of the complimentary perspectives of the regulatory agency, medical examiners, physicians, and pilot or driver are considered in this narrative review, as are considerations for future guideline updates.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009950
Sutton NR, Banerjee S, Cooper MM, Arbab-Zadeh A, ... Rao SV, Blumenthal RS
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009950 | PMID: 34092098
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Impact:
Abstract

Transcatheter Aortic Valve Replacement for Degenerated Transcatheter Aortic Valves: The TRANSIT International Project.

Testa L, Agnifili M, Van Mieghem NM, Tchétché D, ... Sondergaard L, Bedogni F
Background
Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bioprostheses is still a matter of concern, and little is known about the management of degenerated TAV. We sought to evaluate the outcomes of patients with a degenerated TAV treated by means of a second TAVR.
Methods
The TRANSIT is an international registry that included cases of degenerated TAVR from 28 centers. Among around 40 000 patients treated with TAVR in the participating centers, 172 underwent a second TAVR: 57 (33%) for a mainly stenotic degenerated TAV, 97 (56%) for a mainly regurgitant TAV, and 18 (11%) for a combined degeneration. Overall, the rate of New York Heart Association class III/IV at presentation was 73.5%.
Results
Valve Academic Research Consortium 2 device success rate was 79%, as a consequence of residual gradient (14%) or regurgitation (7%). At 1 month, the overall mortality rate was 2.9%, while rates of new hospitalization and New York Heart Association class III/IV were 3.6% and 7%, respectively, without significant difference across the groups. At 1 year, the overall mortality rate was 10%, while rates of new hospitalization and New York Heart Association class III/IV were 7.6% and 5.8%, respectively, without significant difference across the groups. No cases of valve thrombosis were recorded.
Conclusions
Selected patients with a degenerated TAV may be safely and successfully treated by means of a second TAVR. This finding is of crucial importance for the adoption of the TAVR technology in a lower risk and younger population.
Registration
URL: https://www.clinicaltrials.gov; Unique identifier: NCT04500964.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e010440
Testa L, Agnifili M, Van Mieghem NM, Tchétché D, ... Sondergaard L, Bedogni F
Circ Cardiovasc Interv: 30 Dec 2020; 14:e010440 | PMID: 34092097
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Abstract

Correlation of Intravascular Ultrasound and Instantaneous Wave-Free Ratio in Patients With Intermediate Left Main Coronary Artery Disease.

El Hajj SC, Toya T, Warisawa T, Nan J, ... Davies JE, Lerman A
Background
There is great degree of interobserver variability in the visual angiographic assessment of left main coronary disease (LMCD). Fractional flow reserve and intravascular ultrasound are often used in this setting. The use of instantaneous wave-free ratio (iFR) for evaluation of LMCD has not been well studied. The aim of this study is to evaluate the use of iFR in the assessment of angiographically intermediate LMCD.
Methods
This is an international multicenter retrospective observational study of patients who underwent both iFR and intravascular ultrasound evaluation for angiographically intermediate LMCD. An independent core laboratory performed blinded off-line analysis of all intravascular ultrasound data. A minimum lumen area of 6 mm2 was used as the cutoff for significant disease.
Results
One hundred twenty-five patients (mean age, 68.4±9.5 years, 84.8% male) were included in this analysis. Receiver operating curve analysis showed that an iFR of ≤0.89 identified minimum lumen area <6 mm2 with an area under the curve of 0.77 (77% sensitivity, 66% specificity; P<0.0001). Among the 69 patients without ostial left anterior descending artery or left circumflex artery disease, receiver operating curve analysis showed that an iFR of ≤0.89 identified minimum lumen area <6 mm2 with an area under the curve of 0.84 (70% sensitivity, 84% specificity; P<0.0001). The correlation was not significantly different when the body surface area was considered.
Conclusions
In this study, in patients with intermediate LMCD, iFR of ≤0.89 correlates with intravascular ultrasound minimum lumen area <6 mm2 regardless of body surface area. The current study supports the use of iFR for the evaluation of intermediate LMCD.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009830
El Hajj SC, Toya T, Warisawa T, Nan J, ... Davies JE, Lerman A
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009830 | PMID: 34092096
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Abstract

Aortic Valve Surgery After Neonatal Balloon Aortic Valvuloplasty in Congenital Aortic Stenosis.

Kido T, Guariento A, Doulamis IP, Porras D, ... Del Nido PJ, Nathan M
Background
We sought to identify predictive factors for aortic valve (AoV) surgery after neonatal balloon aortic valvuloplasty (BAV) and characterize clinical outcomes of AoV surgery after neonatal BAV.
Methods
Time-to-event analysis identified predictors for AoV surgery after neonatal BAV. Clinical outcomes of AoV surgery following neonatal BAV were examined.
Results
This study included 96 consecutive patients who underwent neonatal BAV for congenital aortic stenosis between 1998 and 2018, in 26 of whom a fetal BAV had been performed. Fifty-six patients underwent AoV surgery at a median age of 2.0 years. Significant risk factors for AoV surgery in univariate Cox regression (result presented as hazard ratio [HR], [95% CI]; P value) were a history of fetal BAV (HR, 4.05 [95% CI, 2.19–7.40]; P<0.001), AoV annulus diameter Z score (HR, 0.56 [95% CI, 0.43–0.75]; P=0.001), the presence of endocardial fibroelastosis (HR, 2.61 [95% CI, 1.48–4.51]; P=0.001), severe left ventricular dysfunction before neonatal BAV (HR, 1.75 [95% CI, 1.03–2.97]; P=0.04), and recent era (HR, 3.08 [95% CI, 1.68–5.91]; P=0.0002) in the entire cohort. Area under the receiver operating characteristic curve and Youden J index analysis identified a cutoff value for AoV annulus diameter Z score of −2.6 in patients without fetal BAV. In 24 patients with midterm cardiac catheterization data, univariate linear regression analysis (result presented as B coefficient [95% CI]; P) showed that the presence of greater-than-moderate aortic regurgitation immediately after BAV (B coefficient, 4.8 [95% CI, 1.0–8.6]; P=0.018) and before AoV surgery (B coefficient, 6.1 [95% CI, 2.2–10.0]; P=0.004) were significant risk factors for elevated left ventricular end-diastolic pressure after AoV surgery, while concomitant endocardial fibroelastosis resection at AoV surgery had a protective effect (B coefficient, −3.8 [95% CI, −7.6 to −0.06]; P=0.05).
Conclusions
A small AoV annulus diameter Z score with a cutoff value of −2.6 and a history of fetal BAV were significantly associated with AoV surgery after neonatal BAV. Concomitant endocardial fibroelastosis resection is recommended at AoV surgery following neonatal BAV to improve left ventricular diastolic function.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e009933
Kido T, Guariento A, Doulamis IP, Porras D, ... Del Nido PJ, Nathan M
Circ Cardiovasc Interv: 30 Dec 2020; 14:e009933 | PMID: 34092095
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Abstract

Atherectomy and Drug-Coated Balloon Angioplasty for the Treatment of Long Infrapopliteal Lesions: A Randomized Controlled Trial.

Rastan A, Brodmann M, Böhme T, Macharzina R, ... Neumann FJ, Zeller T
Background
Prospective, randomized, multicenter trials show no beneficial impact of drug-coated balloon (DCB) therapy alone on the technical and clinical outcomes of infrapopliteal artery lesions in comparison to plain old balloon angioplasty. The aim of this study was to evaluate the performance of directional atherectomy (DA) plus DCB angioplasty versus DCB alone in treatment of long infrapopliteal artery lesions.
Methods
We conducted a prospective, randomized, 2-center trial comparing the performance of DA+DCB and DCB alone in treatment of 80 patients with de novo infrapopliteal artery lesions. The primary study end point was the 6-month primary patency of the target lesion detected by angiography and duplex ultrasound. Secondary end points included clinically driven target vessel revascularization, amputation rates, and changes in Rutherford-Becker class at 1 year. A core laboratory provides independent analyses for all scheduled and unscheduled duplex ultrasound examinations and angiographies, and a research institute ensured independent data collection.
Results
The mean target lesion length was 179.7±98.2 mm. Nine patients (11.3%) died during the follow-up period. At 6 months, primary patency was 49% (n=18) with DA+DCB versus 34% (n=12) with DCB alone (P=0.241), and clinically driven target vessel revascularization was 8% (n=3) versus 14% (n=5; P=0.475), respectively. At 1 year, the target lesion revascularization rates were 30% (n=10) versus 43% (n=12; P=0.308), the median in Rutherford-Becker class was 2 (0.25–5) versus 5 (0.25–5; P=0.329), and amputation rates were 22% (n=8) versus 32% (n=11; P=0.618) in the DA+DCB group and the DCB group, respectively.
Conclusions
Treatment of long infrapopliteal artery lesions with DA+DCB versus DCB alone leads to comparable clinical and technical results at 6 months and 1 year.
Registration
https://www.clinicaltrials.gov; Unique identifier: NCT01763476.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e010280
Rastan A, Brodmann M, Böhme T, Macharzina R, ... Neumann FJ, Zeller T
Circ Cardiovasc Interv: 30 Dec 2020; 14:e010280 | PMID: 34092093
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Impact:
Abstract

Five-Year Clinical and Quality of Life Outcomes From the CoreValve US Pivotal Extreme Risk Trial.

Arnold SV, Petrossian G, Reardon MJ, Kleiman NS, ... Cohen DJ, US CoreValve Investigators
Background
Older adults with comorbidities who are at extreme risk for surgical aortic valve replacement may be appropriate candidates for transcatheter aortic valve replacement (TAVR). We present the 5-year clinical, echocardiographic, and health status outcomes of such patients treated with CoreValve self-expanding supra-annular TAVR.
Methods
The CoreValve US Extreme Risk Pivotal Trial was a prospective, nonrandomized, single-arm clinical trial of TAVR at 41 sites in the United States. The primary outcome was all-cause mortality or major stroke. Secondary outcomes included echocardiographic parameters and patient-reported health status, assessed with the Kansas City Cardiomyopathy Questionnaire.
Results
Between February 2011 and August 2012, 639 patients with severe aortic stenosis at extreme surgical risk underwent attempted TAVR (mean age 82.8±8.4 years, 53% women, mean Society of Thoracic Surgeons Predicted Risk of Mortality 10.4±5.6%, 77% iliofemoral access). The 5-year Kaplan-Meier rate of death or major stroke was 72.6% ([95% CI, 68.4%–76.7%]; death 71.6%, major stroke 11.5%), with no significant differences according to access site. Among patients who survived 5 years, mean transvalvular gradient was 7.5±5.9 mm Hg, and 3.1% had moderate or severe aortic regurgitation. Health status measures improved significantly by 1 month after TAVR through 1 year (mean change in Kansas City Cardiomyopathy Questionnaire–Overall Summary score 24.8 points [95% CI, 22.4–27.2]). Beyond 1 year, the Kansas City Cardiomyopathy Questionnaire–Overall Summary score decreased gradually but remained significantly improved from pre-TAVR through 5 years of follow-up among surviving patients (mean change from baseline, 14.3 points [95% CI, 10.7–17.9]).
Conclusions
Patients with severe aortic stenosis at extreme surgical risk who are treated with self-expanding supra-annular TAVR have high 5-year mortality. However, the short-term benefits of TAVR in terms of valve hemodynamics and quality of life are mostly preserved among surviving patients at 5 years, thereby supporting the continued use of TAVR in these challenging patients.
Registration
https://www.clinicaltrials.gov; Unique identifier: NCT01240902.



Circ Cardiovasc Interv: 30 Dec 2020; 14:e010258
Arnold SV, Petrossian G, Reardon MJ, Kleiman NS, ... Cohen DJ, US CoreValve Investigators
Circ Cardiovasc Interv: 30 Dec 2020; 14:e010258 | PMID: 34092091
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Impact:

This program is still in alpha version.