Journal: JACC Cardiovasc Interv

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<div><h4>Concomitant Transcatheter Edge-to-Edge Treatment of Secondary Tricuspid and Mitral Regurgitation: An Expert Opinion.</h4><i>Sisinni A, Taramasso M, Praz F, Metra M, ... Adamo M, Godino C</i><br /><AbstractText>Secondary (functional) tricuspid regurgitation (sTR) is common in patients with mitral regurgitation (MR). Because combined valvular heart disease affects long-term survival, in comparison with isolated MR or tricuspid regurgitation, it is essential to offer patients adequate treatment. Despite considerable experience, no conclusive data are yet available on the prognostic impact of concomitant tricuspid valve surgery at the time of mitral valve surgery. Emerging transcatheter treatments offer the opportunity to treat both conditions (MR and sTR) simultaneously or in a stepwise fashion. This review provides a clinical overview on available data regarding the rationale for treatment of sTR in patients with relevant MR undergoing mitral transcatheter edge-to-edge repair, focusing on clinical and anatomical selection criteria.</AbstractText><br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 23 Jan 2023; 16:127-139</small></div>
Sisinni A, Taramasso M, Praz F, Metra M, ... Adamo M, Godino C
JACC Cardiovasc Interv: 23 Jan 2023; 16:127-139 | PMID: 36697147
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<div><h4>Staging Heart Failure Patients With Secondary Mitral Regurgitation Undergoing Transcatheter Edge-to-Edge Repair.</h4><i>Stolz L, Doldi PM, Orban M, Karam N, ... Hausleiter J, EuroSMR Investigators</i><br /><b>Background</b><br />Secondary mitral regurgitation (SMR) is a progressive disease with characteristic pathophysiological changes that may influence prognosis. Although the staging of SMR patients suffering from heart failure with reduced ejection fraction (HFrEF) according to extramitral cardiac involvement has prognostic value in medically treated patients, such data are so far lacking for edge-to-edge mitral valve repair (M-TEER).<br /><b>Objectives</b><br />This study sought to classify M-TEER patients into disease stages based on the phenotype of extramitral cardiac involvement and to assess its impact on symptomatic and survival outcomes.<br /><b>Methods</b><br />Based on echocardiographic and clinical assessment, patients were assigned to 1 of the following HFrEF-SMR groups: left ventricular involvement (Stage 1), left atrial involvement (Stage 2), right ventricular volume/pressure overload (Stage 3), or biventricular failure (Stage 4). A Cox regression model was implemented to investigate the impact of HFrEF-SMR stages on 2-year all-cause mortality. The symptomatic outcome was assessed with New York Heart Association functional class at follow-up.<br /><b>Results</b><br />Among a total of 849 eligible patients who underwent M-TEER for relevant SMR from 2008 until 2019, 9.5% (n = 81) presented with left ventricular involvement, 46% (n = 393) with left atrial involvement, 15% (n = 129) with right ventricular pressure/volume overload, and 29% (n = 246) with biventricular failure. An increase in HFrEF-SMR stage was associated with increased 2-year all-cause mortality after M-TEER (HR: 1.39; CI: 1.23-1.58; P < 0.01). Furthermore, higher HFrEF-SMR stages were associated with significantly less symptomatic improvement at follow-up.<br /><b>Conclusions</b><br />The classification of M-TEER patients into HFrEF-SMR stages according to extramitral cardiac involvement provides prognostic value in terms of postinterventional survival and symptomatic improvement.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 23 Jan 2023; 16:140-151</small></div>
Stolz L, Doldi PM, Orban M, Karam N, ... Hausleiter J, EuroSMR Investigators
JACC Cardiovasc Interv: 23 Jan 2023; 16:140-151 | PMID: 36697148
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<div><h4>The 5 Phenotypes of Tricuspid Regurgitation: Insight From Cluster Analysis of Clinical and Echocardiographic Variables.</h4><i>Anand V, Scott CG, Hyun MC, Lara-Breitinger K, ... Schulte PJ, Pislaru SV</i><br /><b>Background</b><br />The recent morphologic classification of tricuspid regurgitation (TR) (ie, atrial functional, ventricular functional, lead related, and primary) does not capture underlying comorbidities and clinical characteristics.<br /><b>Objectives</b><br />This study aimed to identify the different phenotypes of TR using unsupervised cluster analysis and to determine whether differences in clinical outcomes were associated with these phenotypes.<br /><b>Methods</b><br />We included 13,611 patients with ≥moderate TR from January 2004 to April 2019 in the final analyses. Baseline demographic, clinical, and echocardiographic data were obtained from electronic medical records and echocardiography reports. Ward\'s minimum variance method was used to cluster patients based on 38 variables. The analysis of all-cause mortality was performed using the Kaplan-Meier method, and groups were compared using log-rank test.<br /><b>Results</b><br />The mean age of patients was 72 ± 13 years, and 56% were women. Cluster analysis identified 5 distinct phenotypes: cluster 1 represented \"low-risk TR\" with less severe TR, a lower prevalence of right ventricular enlargement, atrial fibrillation, and comorbidities; cluster 2 represented \"high-risk TR\"; and clusters 3, 4, and 5 represented TR associated with lung disease, coronary artery disease, and chronic kidney disease, respectively. Cluster 1 had the lowest mortality followed by clusters 2 (HR: 2.22 [95% CI: 2.1-2.35]; P < 0.0001) and 4 (HR: 2.19 [95% CI: 2.04-2.35]; P < 0.0001); cluster 3 (HR: 2.45 [95% CI: 2.27-2.65]; P < 0.0001); and, lastly, cluster 5 (HR: 3.48 [95% CI: 3.07-3.95]; P < 0.0001).<br /><b>Conclusions</b><br />Cluster analysis identified 5 distinct novel subgroups of TR with differences in all-cause mortality. This phenotype-based classification improves our understanding of the interaction of comorbidities with this complex valve lesion and can inform clinical decision making.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 23 Jan 2023; 16:156-165</small></div>
Anand V, Scott CG, Hyun MC, Lara-Breitinger K, ... Schulte PJ, Pislaru SV
JACC Cardiovasc Interv: 23 Jan 2023; 16:156-165 | PMID: 36697150
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<div><h4>The Relationship Between Hospital Stroke Center Designation and TVT Reported Stroke: The Michigan TAVR Experience.</h4><i>Grossman PM, Sukul D, Lall SC, Villablanca PA, ... Patel HJ, Deeb GM</i><br /><b>Background</b><br />The 30-day rate of stroke after transcatheter aortic valve replacement (TAVR) has been suggested as a hospital quality metric. Thirty-day stroke rates for nonsurgical, high, and moderate-risk TAVR trials were 3.4% to 6.1%, whereas those in the national Transcatheter Valve Therapy (TVT) Registry for the same patient population were much lower. Hospital comprehensive stroke center (CSC) is the highest designation for integrated acute stroke recognition, management, and care.<br /><b>Objectives</b><br />Using Michigan TVT data, we assessed whether in-hospital post-TAVR stroke rates varied between CSC and non-CSC institutions.<br /><b>Methods</b><br />TVT data submitted from the 22 Michigan Transcatheter Aortic Valve Replacement Collaborative participating institutions between January 1, 2016, and June 30, 2019, were included (N = 6,231). Bayesian hierarchical regression models accounting for patient clinical characteristics and hospital clustering were fitted to assess the association between hospital CSC accreditation and in-hospital post-TAVR stroke. Adjusted ORs and 95% credible intervals were estimated. The University of Michigan Institutional Review Board has waived the need for the approval of studies based on the data collected by the Blue Cross Blue Shield of Michigan Cardiovascular Consortium registry.<br /><b>Results</b><br />There were 3,882 (62.3%) patients at 9 CSC sites and 2,349 (37.7%) patients at 13 non-CSC sites. CSC sites had significantly higher rates of in-hospital post-TAVR stroke (CSC: 2.65% vs non-CSC: 1.15%; P < 0.001). After adjustment, patients who underwent TAVR at a CSC hospital had a significantly higher risk of in-hospital stroke (adjusted OR: 2.21; 95% CI: 1.03-4.62). However, CSC designation was not significantly associated with other important post-TAVR clinical outcomes including 30-day mortality.<br /><b>Conclusions</b><br />Reported Michigan Transcatheter Aortic Valve Replacement Collaborative TVT stroke rates were significantly higher at sites with Joint Hospital Commission stroke designation status; however, other reported important clinical outcomes did not differ significantly based on this designation. CSC designation is a possible factor in stroke rate detection differences between TAVR institutions and might be a factor in the observed differences in stroke rates between TAVR trials and those reported in TVT. In addition, these data suggest that comparison between hospitals based on post-TAVR stroke rates is potentially problematic.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 23 Jan 2023; 16:168-176</small></div>
Grossman PM, Sukul D, Lall SC, Villablanca PA, ... Patel HJ, Deeb GM
JACC Cardiovasc Interv: 23 Jan 2023; 16:168-176 | PMID: 36697152
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<div><h4>Nursing Home Admission Following Transcatheter Aortic Valve Replacement: A Danish Nationwide Cohort Study.</h4><i>Strange JE, Sindet-Pedersen C, Holt A, Andersen MP, ... Olesen JB, Fosbøl EL</i><br /><b>Background</b><br />Loss of autonomy associated with nursing home admission (NHA) is a concern for patients. Yet the incidence of NHA after transcatheter aortic valve replacement (TAVR) is unknown.<br /><b>Objectives</b><br />The aim of this study was to investigate the incidence and factors associated with NHA following TAVR compared with the general population.<br /><b>Methods</b><br />Through Danish registries, patients alive at discharge after TAVR were identified from January 2014 to October 2021. Patients were matched 1:5 on sex, age, and calendar year to the general population. The 3-year cumulative incidence and 95% CI of NHA were estimated using the Aalen-Johansen estimator, accounting for the competing risk for death. Through multivariate cause-specific Cox regression models, factors associated with NHA were examined.<br /><b>Results</b><br />In total, 5,312 TAVR patients were matched to 26,560 control subjects with a median age of 81 years and 56.1% males. Comorbidity burden was higher for TAVR patients. The 3-year cumulative incidence of NHA was 6.3% (95% CI: 5.5%-7.1%) for TAVR patients compared with 5.8% (95% CI: 5.4%-6.1%) for the general population. For TAVR patients >85 years of age, the cumulative incidence of NHA was 11.6% (95% CI: 9.5%-13.8%), and the risk for death was 23.3% (95% CI: 20.4%-26.2%). Factors associated with NHA were increasing age, frailty, living alone, and atrial fibrillation.<br /><b>Conclusions</b><br />TAVR was not associated with an increased incidence of NHA compared with the general population. Despite the increased incidence of NHA for TAVR patients >85 years of age, approximately 2 in 3 patients were still alive and not admitted to nursing homes 3 years after TAVR.<br /><br />Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 23 Jan 2023; 16:179-188</small></div>
Strange JE, Sindet-Pedersen C, Holt A, Andersen MP, ... Olesen JB, Fosbøl EL
JACC Cardiovasc Interv: 23 Jan 2023; 16:179-188 | PMID: 36697154
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<div><h4>Transient vs In-Hospital Persistent Acute Kidney Injury in Patients With Acute Coronary Syndrome.</h4><i>Landi A, Branca M, Leonardi S, Frigoli E, ... Valgimigli M, MATRIX Investigators</i><br /><b>Background</b><br />The occurrence of acute kidney injury (AKI) among patients with acute coronary syndrome (ACS) undergoing invasive management is associated with worse outcomes. However, the prognostic implications of transient or in-hospital persistent AKI may differ.<br /><b>Objectives</b><br />The aim of this study was to evaluate the prognostic implications of transient or in-hospital persistent AKI in patients with ACS.<br /><b>Methods</b><br />In the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) trial, 203 subjects were excluded because of incomplete information or end-stage renal disease, with a study population of 8,201 patients. Transient and persistent AKI were defined as renal dysfunction no longer or still fulfilling the AKI criteria (>0.5 mg/dL or a relative >25% increase in creatinine) at discharge, respectively. Thirty-day coprimary outcomes were the out-of-hospital composite of death, myocardial infarction, or stroke (major adverse cardiovascular events [MACE]) and net adverse cardiovascular events (NACE), defined as the composite of MACE or Bleeding Academic Research Consortium type 3 or 5 bleeding.<br /><b>Results</b><br />Persistent and transient AKI occurred in 750 (9.1%) and 587 (7.2%) subjects, respectively. After multivariable adjustment, compared with patients without AKI, the risk for 30-day coprimary outcomes was higher in patients with persistent AKI (MACE: adjusted HR: 2.32; 95% CI: 1.48-3.64; P < 0.001; NACE: adjusted HR: 2.29; 95% CI: 1.48-3.52; P < 0.001), driven mainly by all-cause mortality (adjusted HR: 3.43; 95% CI: 2.03-5.82; P < 0.001), whereas transient AKI was not associated with higher rates of MACE or NACE. Results remained consistent when implementing the KDIGO (Kidney Disease Improving Global Outcomes) criteria.<br /><b>Conclusions</b><br />Among patients with ACS undergoing invasive management, in-hospital persistent but not transient AKI was associated with higher risk for 30-day MACE and NACE. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox [MATRIX]; NCT01433627).<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 23 Jan 2023; 16:193-205</small></div>
Landi A, Branca M, Leonardi S, Frigoli E, ... Valgimigli M, MATRIX Investigators
JACC Cardiovasc Interv: 23 Jan 2023; 16:193-205 | PMID: 36697156
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<div><h4>Cause-Specific Mortality in Patients With Advanced Chronic Kidney Disease in the ISCHEMIA-CKD Trial.</h4><i>Sidhu MS, Alexander KP, Huang Z, Mathew RO, ... Bangalore S, ISCHEMIA-CKD Research Group</i><br /><b>Background</b><br />In ISCHEMIA-CKD, 777 patients with advanced chronic kidney disease and chronic coronary disease had similar all-cause mortality with either an initial invasive or conservative strategy (27.2% vs 27.8%, respectively).<br /><b>Objectives</b><br />This prespecified secondary analysis from ISCHEMIA-CKD (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Chronic Kidney Disease) was conducted to determine whether an initial invasive strategy compared with a conservative strategy decreased the incidence of cardiovascular (CV) vs non-CV causes of death.<br /><b>Methods</b><br />Three-year cumulative incidences were calculated for the adjudicated cause of death. Overall and cause-specific death by treatment strategy were analyzed using Cox models adjusted for baseline covariates. The association between cause of death, risk factors, and treatment strategy were identified.<br /><b>Results</b><br />A total of 192 of the 777 participants died during follow-up, including 94 (12.1%) of a CV cause, 59 (7.6%) of a non-CV cause, and 39 (5.0%) of an undetermined cause. The 3-year cumulative rates of CV death were similar between the invasive and conservative strategies (14.6% vs 12.6%, respectively; HR: 1.13, 95% CI: 0.75-1.70). Non-CV death rates were also similar between the invasive and conservative arms (8.4% and 8.2%, respectively; HR: 1.25; 95% CI: 0.75-2.09). Sudden cardiac death (46.8% of CV deaths) and infection (54.2% of non-CV deaths) were the most common cause-specific deaths and did not vary by treatment strategy.<br /><b>Conclusions</b><br />In ISCHEMIA-CKD, CV death was more common than non-CV or undetermined death during the 3-year follow-up. The randomized treatment assignment did not affect the cause-specific incidences of death in participants with advanced CKD and moderate or severe myocardial ischemia. (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Chronic Kidney Disease [ISCHEMIA-CKD]; NCT01985360).<br /><br />Copyright © 2023 American College of Cardiology Foundation. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 23 Jan 2023; 16:209-218</small></div>
Sidhu MS, Alexander KP, Huang Z, Mathew RO, ... Bangalore S, ISCHEMIA-CKD Research Group
JACC Cardiovasc Interv: 23 Jan 2023; 16:209-218 | PMID: 36697158
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<div><h4>Timing, Selection, Modulation, and Duration of P2Y Inhibitors for Patients With Acute Coronary Syndromes Undergoing PCI.</h4><i>Capodanno D, Angiolillo DJ</i><br /><AbstractText>Dual antiplatelet therapy with aspirin and the oral P2Y<sub>12</sub> inhibitor clopidogrel as the cornerstone of treatment for patients with an acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) was firstly established in 2001. Soon thereafter, the newer-generation P2Y<sub>12</sub> inhibitors prasugrel and ticagrelor became commercially available. The clinical management of ACS patients undergoing PCI has evolved significantly in the last 2 decades, with a shift toward more rapid invasive management, broader use of drug-eluting stents, and the increasing recognition that major bleeding due to antiplatelet therapy is detrimental. In this ever-changing scenario, numerous studies have addressed 4 main questions regarding P2Y<sub>12</sub> inhibition in ACS patients undergoing PCI: timing, selection, modulation, and duration. This paper reviews the latest evidence surrounding these topical questions, with a focus on efficacy and safety data, practice guidelines, and residual areas of uncertainty.</AbstractText><br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 09 Jan 2023; 16:1-18</small></div>
Capodanno D, Angiolillo DJ
JACC Cardiovasc Interv: 09 Jan 2023; 16:1-18 | PMID: 36599574
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<div><h4>Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Patients With Diabetes Undergoing Percutaneous Coronary Intervention.</h4><i>Yamamoto K, Watanabe H, Morimoto T, Obayashi Y, ... Kimura T, STOPDAPT-2 and STOPDAPT-2 ACS Investigators</i><br /><b>Background</b><br />Diabetes was reported to be associated with an impaired response to clopidogrel.<br /><b>Objectives</b><br />The aim of this study was to evaluate the safety and efficacy of clopidogrel monotherapy after very short dual antiplatelet therapy (DAPT) in patients with diabetes undergoing percutaneous coronary intervention (PCI).<br /><b>Methods</b><br />A subgroup analysis was conducted on the basis of diabetes in the STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2) Total Cohort (N = 5,997) (STOPDAPT-2, n = 3,009; STOPDAPT-2 ACS [Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2 for the Patients With ACS], n = 2,988), which randomly compared 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT with aspirin and clopidogrel after cobalt-chromium everolimus-eluting stent implantation. The primary endpoint was a composite of cardiovascular (cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) or bleeding (TIMI [Thrombolysis In Myocardial Infarction] major or minor) endpoints at 1 year.<br /><b>Results</b><br />There were 2,030 patients with diabetes (33.8%) and 3967 patients without diabetes (66.2%). Regardless of diabetes, the risk of 1-month DAPT relative to 12-month DAPT was not significant for the primary endpoint (diabetes, 3.58% vs 4.12% [HR: 0.87; 95% CI: 0.56-1.37; P = 0.55]; nondiabetes, 2.46% vs 2.49% [HR: 0.99; 95% CI: 0.67-1.48; P = 0.97]; P<sub>interaction</sub> = 0.67) and for the cardiovascular endpoint (diabetes, 3.28% vs 3.05% [HR: 1.10; 95% CI: 0.67-1.81; P = 0.70]; nondiabetes, 1.95% vs 1.43% [HR: 1.38; 95% CI: 0.85-2.25; P = 0.20]; P<sub>interaction</sub> = 0.52), while it was lower for the bleeding endpoint (diabetes, 0.30% vs 1.50% [HR: 0.20; 95% CI: 0.06-0.68; P = 0.01]; nondiabetes, 0.61% vs 1.21% [HR: 0.51; 95% CI: 0.25-1.01; P = 0.054]; P<sub>interaction</sub> = 0.19).<br /><b>Conclusions</b><br />Clopidogrel monotherapy after 1-month DAPT compared with 12-month DAPT reduced major bleeding events without an increase in cardiovascular events regardless of diabetes, although the findings should be considered as hypothesis generating, especially in patients with acute coronary syndrome, because of the inconclusive result in the STOPDAPT-2 ACS trial. (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2 [STOPDAPT-2], NCT02619760; Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2 for the Patients With ACS [STOPDAPT-2 ACS], NCT03462498).<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 09 Jan 2023; 16:19-31</small></div>
Yamamoto K, Watanabe H, Morimoto T, Obayashi Y, ... Kimura T, STOPDAPT-2 and STOPDAPT-2 ACS Investigators
JACC Cardiovasc Interv: 09 Jan 2023; 16:19-31 | PMID: 36599584
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<div><h4>Simultaneous Hybrid Coronary Revascularization vs Conventional Strategies for Multivessel Coronary Artery Disease: A 10-Year Follow-Up.</h4><i>Ding T, Yuan X, Chen K, Shen L, ... Wu Y, Hu S</i><br /><b>Background</b><br />Although evidence is sufficient to confirm that hybrid coronary revascularization (HCR) is safe and effective in the short term, its value in the long run is debatable.<br /><b>Objectives</b><br />This study sought to compare the long-term outcomes of HCR with coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for multivessel disease.<br /><b>Methods</b><br />Three groups of patients, 540 each, receiving HCR, CABG, or PCI between June 2007 to September 2018, were matched using propensity score matching. Patients were stratified by EuroSCORE (European System for Cardiac Operative Risk Evaluation) II (low ≤0.9; 0.9 < medium <1.5; high ≥1.5) and SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (low ≤22; 22 < medium <33; high ≥33). Major adverse cardiac and cerebrovascular events (MACCE) and Seattle Angina Questionnaire (SAQ) scores were compared among the 3 groups.<br /><b>Results</b><br />In terms of MACCE and SAQ, HCR performed similarly to off-pump CABG but significantly outperformed PCI (P < 0.001). In the low-to-medium EuroSCORE II and medium-to-high SYNTAX score tertiles, MACCE rates in the HCR group were significantly lower than those in the PCI (EuroSCORE II: low, 30.7% vs 41.2%; P = 0.006; medium, 31.3% vs 41.7%; P = 0.013; SYNTAX score: medium, 27.6% vs 41.2%; P = 0.018; high, 32.4% vs 52.7%; P = 0.011) but were similar to those in the CABG group. In the high EuroSCORE II stratum, HCR had a lower MACCE rate than CABG (31.9% vs 47.0%; P = 0.041) and PCI (31.9% vs 53.7%; P = 0.015).<br /><b>Conclusions</b><br />Compared with conventional strategies, HCR provided satisfactory long-term outcomes in MACCE and functional status for multivessel disease.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>JACC Cardiovasc Interv: 09 Jan 2023; 16:50-60</small></div>
Ding T, Yuan X, Chen K, Shen L, ... Wu Y, Hu S
JACC Cardiovasc Interv: 09 Jan 2023; 16:50-60 | PMID: 36599587
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<div><h4>Early Invasive Strategy Based on the Time of Symptom Onset of Non-ST-Segment Elevation Myocardial Infarction.</h4><i>Bae S, Cha JJ, Lim S, Kim JH, ... Jeong MH, Ahn TH</i><br /><b>Background</b><br />A limitation of the current guidelines regarding the timing of invasive coronary angiography for patients with non-ST-segment elevation acute coronary syndrome is the randomization time. To date, no study has reported the clinical outcomes of invasive strategy timing on the basis of the time of symptom onset.<br /><b>Objectives</b><br />The aim of this study was to investigate the effect of invasive strategy timing from the time of symptom onset on the 3-year clinical outcomes of patients with non-ST-segment elevation myocardial infarction (NSTEMI).<br /><b>Methods</b><br />Among 13,104 patients from the Korea Acute Myocardial Infarction Registry-National Institutes of Health, 5,856 patients with NSTE myocardial infarction were evaluated. The patients were categorized according to symptom-to-catheter (StC) time (<48 or ≥48 hours). The primary outcome was 3-year all-cause mortality.<br /><b>Results</b><br />Overall, 3,919 patients (66.9%) were classified into the StC time <48 hours group. This group had lower all-cause mortality than the group with StC time ≥48 hours (7.3% vs 13.4%; P < 0.001). The lower risk for all-cause mortality in the group with StC time <48 hours group was consistent in all subgroups. Notably, emergency medical service use (HR: 0.31; 95% CI: 0.19-0.52) showed a lower risk for all-cause mortality than no emergency medical service use (HR: 0.54; 95% CI: 0.46-0.65; P value for interaction = 0.008).<br /><b>Conclusions</b><br />An early invasive strategy on the basis of StC time was associated with a decreased risk for all-cause mortality in patients with NSTEMI. Because the study was based on a prospective registry, the results should be considered hypothesis generating, highlighting the need for further research. (iCReaT Study No. C110016).<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 09 Jan 2023; 16:64-75</small></div>
Bae S, Cha JJ, Lim S, Kim JH, ... Jeong MH, Ahn TH
JACC Cardiovasc Interv: 09 Jan 2023; 16:64-75 | PMID: 36599589
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<div><h4>No Antithrombotic Therapy After Transcatheter Aortic Valve Replacement: Insight From the OCEAN-TAVI Registry.</h4><i>Kobari Y, Inohara T, Tsuruta H, Yashima F, ... Yamamoto M, Hayashida K</i><br /><b>Background</b><br />Several trials demonstrated that aspirin monotherapy compared with aspirin plus clopidogrel is associated with a lower incidence of bleeding without an increased risk of ischemic events in patients after transcatheter aortic valve replacement (TAVR); however, there remains a paucity of data to prove the necessity of even aspirin monotherapy.<br /><b>Objectives</b><br />This study aimed to compare clinical outcomes and valve performance of the 3 different antithrombotic strategies post-TAVR from the OCEAN-TAVI (Optimized transCathEter vAlvular iNtervention) registry.<br /><b>Methods</b><br />Patients who received anticoagulation or had procedural complications were excluded. The remaining patients were classified into 3 groups according to the antithrombotic regimen at discharge: 1) nonantithrombotic therapy (None); 2) single-antiplatelet therapy (SAPT); and 3) dual-antiplatelet therapy (DAPT). The primary outcome was the incidence of net adverse clinical events (NACEs) (ie, cardiovascular death, stroke, myocardial infarction, and life-threatening or major bleeding).<br /><b>Results</b><br />Overall, 3,575 TAVR patients were included (None, 293; SAPT, 1,354; DAPT, 1,928). The median follow-up period was 841 days (IQR: 597-1,340 days). The incidence of NACEs did not differ between the groups (None vs SAPT: adjusted HR [aHR]: 1.18; P = 0.45; None vs DAPT: aHR: 1.09; P = 0.67). There was a lower incidence of all bleeding in patients with no antithrombotics (None vs SAPT: aHR: 0.63; P = 0.12; None vs DAPT: aHR: 0.51; P = 0.04). The valve performance was similar among the groups. Leaflet thrombosis was detected in 8.5% of the nonantithrombotic group.<br /><b>Conclusions</b><br />Compared with SAPT/DAPT, the nonantithrombotic strategy was not associated with an increased risk of NACEs and potentially reduced the risk of bleeding events. The nonantithrombotic strategy may be an acceptable alternative to SAPT/DAPT in selected patients with TAVR.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 09 Jan 2023; 16:79-91</small></div>
Kobari Y, Inohara T, Tsuruta H, Yashima F, ... Yamamoto M, Hayashida K
JACC Cardiovasc Interv: 09 Jan 2023; 16:79-91 | PMID: 36599591
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<div><h4>First-in-Human Dedicated Leaflet Splitting Device for Prevention of Coronary Obstruction in Transcatheter Aortic Valve Replacement.</h4><i>Dvir D, Leon MB, Abdel-Wahab M, Unbehaun A, ... Klein C, Kempfert J</i><br /><b>Background</b><br />Coronary artery obstruction is a life-threatening complication of transcatheter aortic valve replacement (TAVR) procedures. Current preventive strategies are suboptimal.<br /><b>Objectives</b><br />The aim of this study was to describe bench testing and clinical experience with a novel device that splits valve leaflets that are at risk for causing coronary obstruction after TAVR, allowing normal coronary flow.<br /><b>Methods</b><br />The ShortCut device was initially tested in vitro and preclinically in a porcine model for functionality and safety. The device was subsequently offered to patients at elevated risk for coronary obstruction. Risk for coronary obstruction was based on computed tomography-based anatomical characteristics. Procedure success was determined as patient survival at 30 days with a functioning new valve, without stroke or coronary obstruction.<br /><b>Results</b><br />Following a successful completion of bench testing and preclinical trial, the device was used in 8 patients with failed bioprosthetic valves (median age 81 years; IQR: 72-85 years; 37.5% man) at 2 medical centers. A total of 11 leaflets were split: 5 patients (63.5%) were considered at risk for left main obstruction alone, and 3 patients (37.5%) were at risk for double coronary obstruction. All patients underwent successful TAVR without evidence of coronary obstruction. All patients were discharged from the hospital in good clinical condition, and no adverse neurologic events were noted. Procedure success was 100%.<br /><b>Conclusions</b><br />Evaluation of the first dedicated transcatheter leaflet-splitting device shows that the device can successfully split degenerated bioprosthetic valve leaflets. The procedure was safe and successfully prevented coronary obstruction in patients at risk for this complication following TAVR.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 09 Jan 2023; 16:94-102</small></div>
Dvir D, Leon MB, Abdel-Wahab M, Unbehaun A, ... Klein C, Kempfert J
JACC Cardiovasc Interv: 09 Jan 2023; 16:94-102 | PMID: 36599593
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<div><h4>Clinical Impact of Drug-Coated Balloon-Based Percutaneous Coronary Intervention in Patients With Multivessel Coronary Artery Disease.</h4><i>Shin ES, Jun EJ, Kim S, Kim B, ... Jeong YH, Choi BJ</i><br /><b>Background</b><br />Data on drug-coated balloon (DCB) treatment in the context of multivessel coronary artery disease (CAD) are limited.<br /><b>Objectives</b><br />To investigate the impact of DCB-based treatment on percutaneous coronary intervention for multivessel CAD.<br /><b>Methods</b><br />A total of 254 patients with multivessel disease successfully treated with DCBs or in combination with drug-eluting stents (DES) were retrospectively enrolled (DCB-based group) and compared with 254 propensity-matched patients treated with second-generation DES from the PTRG-DES (Platelet Function and Genotype-Related Long-Term Prognosis in Drug-Eluting Stent-Treated Patients With Coronary Artery Disease) registry (n = 13,160 patients) (DES-only group). Major adverse cardiovascular events (MACE) comprised cardiac death, myocardial infarction, stroke, stent thrombosis, target vessel revascularization, and major bleeding at 2 years.<br /><b>Results</b><br />Baseline clinical characteristics were comparable between the groups. In the DCB-based group, 34.3% of patients were treated with DCBs only and 65.7% were treated with the DES hybrid approach. The number of stents and total stent length were significantly reduced by 65.4% and 63.7%, respectively, in the DCB-based group compared with the DES-only group. Moreover, the DCB-based group had a lower rate of MACE than the DES-only group (3.9% and 11.0%; P = 0.002) at 2-year follow-up. The DES-only group had a higher risk for cardiac death and major bleeding.<br /><b>Conclusions</b><br />The DCB-based treatment approach showed a significantly reduced stent burden for multivessel percutaneous coronary intervention and led to a lower rate of MACE than the DES-only treatment. This study shows that DCB-based treatment approach safely reduces stent burden in multivessel CAD, and improved long-term outcomes may be expected by reducing stent-related events. (Impact of Drug-Coated Balloon Treatment in De Novo Coronary Lesion; NCT04619277).<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 28 Dec 2022; epub ahead of print</small></div>
Shin ES, Jun EJ, Kim S, Kim B, ... Jeong YH, Choi BJ
JACC Cardiovasc Interv: 28 Dec 2022; epub ahead of print | PMID: 36609038
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<div><h4>Real-World Examination of Revascularization Strategies for Left Main Coronary Disease in Ontario, Canada.</h4><i>Tam DY, Fang J, Rocha RV, Rao SV, ... Fremes SE, Lee DS</i><br /><b>Background</b><br />Randomized trials have compared percutaneous coronary intervention and coronary artery bypass grafting (CABG) in patients with left main coronary artery disease undergoing nonemergent revascularization. However, there is a paucity of real-world contemporary observational studies comparing percutaneous coronary intervention (PCI) and CABG.<br /><b>Objectives</b><br />To compare the long-term clinical outcomes of CABG versus PCI in patients with left main coronary disease.<br /><b>Methods</b><br />Clinical and administrative databases for Ontario, Canada, were linked to obtain records of all patients with angiographic evidence of left main coronary artery disease (≥50% stenosis) treated with either isolated CABG or PCI from 2008 to 2020. Emergent, cardiogenic shock, and ST-segment elevation myocardial infarction patients were excluded. Baseline characteristics of patients were compared and 1:1 propensity score matching was performed. Late mortality and major adverse cardiac and cerebrovascular events were compared between the matched groups using a Cox proportional hazard model.<br /><b>Results</b><br />After exclusions, 1,299 and 21,287 patients underwent PCI and CABG, respectively. Prior to matching, PCI patients were older (75.2 vs 68.0 years) and more likely to be women (34.6% vs 20.1%), although they had less CAD burden. Propensity score matching on 25 baseline covariates yielded 1,128 well-matched pairs. There was no difference in early mortality between PCI and CABG (5.5% vs 3.9%; P = 0.075). Over 7-year follow-up, all-cause mortality (53.6% vs 35.2%; HR: 1.63; 95% CI: 1.42-1.87; P < 0.001) and major adverse cardiac and cerebrovascular events (66.8% vs 48.6%; HR: 1.77; 95% CI: 1.57-2.00) were significantly higher with PCI than CABG.<br /><b>Conclusions</b><br />CABG was the most common revascularization strategy in this real-world registry. Patients undergoing PCI were much older and of higher risk at baseline. After matching, there was no difference in early mortality but improved late survival and freedom from major adverse cardiac and cerebrovascular events with CABG.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>JACC Cardiovasc Interv: 28 Dec 2022; epub ahead of print</small></div>
Tam DY, Fang J, Rocha RV, Rao SV, ... Fremes SE, Lee DS
JACC Cardiovasc Interv: 28 Dec 2022; epub ahead of print | PMID: 36609048
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<div><h4>Variation in Survival After Cardiopulmonary Arrest in Cardiac Catheterization Laboratories in the United States.</h4><i>Tripathi A, Chan PS, Albagdadi MS, Khan MS, ... Bhatt DL, American Heart Association’s Get With the Guidelines Resuscitation Investigators</i><br /><b>Background</b><br />In-hospital cardiac arrest during cardiac catheterization is not uncommon. The extent of variation in survival after cardiac arrest occurring in the cardiac catheterization laboratory (CCL) and underlying factors are not well known.<br /><b>Objectives</b><br />The aim of this study was to identify the factors associated with higher survival rates after an index cardiac arrest in the CCL.<br /><b>Methods</b><br />Within the GWTG (Get With The Guidelines)-Resuscitation registry, patients ≥18 years of age who had index in-hospital cardiac arrest in the CCL between January 1, 2003, and December 31, 2017, were identified. Hierarchical models were used to adjust for demographics, comorbidities, and cardiac arrest characteristics to generate risk-adjusted survival rates (RASRs) to discharge for each hospital with ≥5 cases during the study period. Median OR was used to quantify the extent of hospital-level variation in RASR.<br /><b>Results</b><br />The study included 4,787 patients from 231 hospitals. The median RASR was 36% (IQR: 21%) and varied from a median of 20% to 52% among hospitals in the lowest and highest tertiles of RASR, respectively. The median OR was 1.71 (95% CI: 1.52-1.87), suggesting that the odds of survival for patients with identical characteristics with in-hospital cardiac arrest in the CCL from 2 randomly chosen different hospitals varied by 71%. Hospitals with greater annual numbers of cardiac arrest cases in the CCL had higher RASRs.<br /><b>Conclusions</b><br />Even in controlled settings such as the CCL, there is significant hospital-level variation in survival after in-hospital cardiac arrest, which suggests an important opportunity to improve resuscitation outcomes in procedural areas.<br /><br />Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 26 Dec 2022; 15:2463-2471</small></div>
Tripathi A, Chan PS, Albagdadi MS, Khan MS, ... Bhatt DL, American Heart Association’s Get With the Guidelines Resuscitation Investigators
JACC Cardiovasc Interv: 26 Dec 2022; 15:2463-2471 | PMID: 36543439
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<div><h4>Association of Residual Ischemic Disease With Clinical Outcomes After Percutaneous Coronary Intervention.</h4><i>Kovach CP, Hebbe A, Glorioso TJ, Barrett C, ... Valle JA, Waldo SW</i><br /><b>Background</b><br />Anatomical scoring systems have been used to assess completeness of revascularization but are challenging to apply to large real-world datasets.<br /><b>Objectives</b><br />The aim of this study was to assess the prevalence of complete revascularization and its association with longitudinal clinical outcomes in the U.S. Department of Veterans Affairs (VA) health care system using an automatically computed anatomic complexity score.<br /><b>Methods</b><br />Patients undergoing percutaneous coronary intervention (PCI) between October 1, 2007, and September 30, 2020, were identified, and the burden of prerevascularization and postrevascularization ischemic disease was quantified using the VA SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score. The association between residual VA SYNTAX score and long-term major adverse cardiovascular events (MACE; death, myocardial infarction, repeat revascularization, and stroke) was assessed.<br /><b>Results</b><br />A total of 57,476 veterans underwent PCI during the study period. After adjustment, the highest tertile of residual VA SYNTAX score was associated with increased hazard of MACE (HR: 2.06; 95% CI: 1.98-2.15) and death (HR: 1.50; 95% CI: 1.41-1.59) at 3 years compared to complete revascularization (residual VA SYNTAX score = 0). Hazard of 1- and 3-year MACE increased as a function of residual disease, regardless of baseline disease severity or initial presentation with acute or chronic coronary syndrome.<br /><b>Conclusions</b><br />Residual ischemic disease was strongly associated with long-term clinical outcomes in a contemporary national cohort of PCI patients. Automatically computed anatomic complexity scores can be used to assess the longitudinal risk for residual ischemic disease after PCI and may be implemented to improve interventional quality.<br /><br />Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 26 Dec 2022; 15:2475-2486</small></div>
Kovach CP, Hebbe A, Glorioso TJ, Barrett C, ... Valle JA, Waldo SW
JACC Cardiovasc Interv: 26 Dec 2022; 15:2475-2486 | PMID: 36543441
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<div><h4>Outcomes of Functionally Complete vs Incomplete Revascularization: Insights From the FAVOR III China Trial.</h4><i>Zhang R, Wang HY, Dou K, Yin D, ... Stone GW, FAVOR III China Study Group</i><br /><b>Background</b><br />Functional complete revascularization (FCR) after percutaneous coronary intervention (PCI) as determined by the residual functional SYNTAX score (rFSS) based on pressure wire fractional flow reserve assessment has been associated with an improved prognosis.<br /><b>Objectives</b><br />This study sought to determine the rates and clinical implications of FCR as assessed by the quantitative flow ratio (QFR), and to determine the outcomes of pre-PCI QFR guidance compared with standard angiography guidance in patients achieving and not achieving FCR after PCI.<br /><b>Methods</b><br />In the randomized, sham-controlled, blinded, multicenter FAVOR (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease) III China trial, QFR-guided PCI reduced the 1-year rate of major adverse cardiac events (MACE) compared with angiography-guided PCI. In the present prespecified substudy, the incidence of MACE was compared according to the presence of post-PCI FCR (rFSS = 0 based on core laboratory-assessed QFR) in the QFR-guided and angiography-guided groups.<br /><b>Results</b><br />Among 3,781 patients with available rFSS assessments, 3,221 (85.2%) achieved FCR, including 88.1% after QFR guidance and 82.2% after angiography guidance (P < 0.001). Patients with FCR had a markedly lower rate of 1-year MACE compared with those with functional incomplete revascularization (FIR) (rFSS ≥1) (5.1% vs 19.7%; P < 0.001). Prognostic models including the rFSS had higher discrimination and reclassification ability than those with the anatomic residual SYNTAX score. The relative risks for 1-year MACE with QFR-guided compared with the angiography-guided lesion selection were consistent in patients achieving FCR (4.1% vs 6.3%; HR: 0.65; 95% CI: 0.47-0.88) and in those with FIR (18.7% vs 20.4%; HR: 0.90; 95% CI: 0.61-1.32) (P<sub>interaction</sub> = 0.19).<br /><b>Conclusions</b><br />In this large-scale trial, achieving FCR after PCI was associated with markedly lower 1-year rates of MACE. Compared with standard angiography guidance, QFR-guided PCI lesion selection improved the likelihood of achieving FCR and improved 1-year clinical outcomes in patients with both FCR and FIR.<br /><br />Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 26 Dec 2022; 15:2490-2502</small></div>
Zhang R, Wang HY, Dou K, Yin D, ... Stone GW, FAVOR III China Study Group
JACC Cardiovasc Interv: 26 Dec 2022; 15:2490-2502 | PMID: 36543443
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<div><h4>Differential Improvement in Angina and Health-Related Quality of Life After PCI in Focal and Diffuse Coronary Artery Disease.</h4><i>Collet C, Collison D, Mizukami T, McCartney P, ... De Bruyne B, Oldroyd K</i><br /><b>Background</b><br />An increase in fractional flow reserve (FFR) after percutaneous coronary intervention (PCI) is associated with improvement in angina. Coronary artery disease (CAD) patterns (focal vs diffuse) influence the FFR change after stenting and may predict angina relief.<br /><b>Objectives</b><br />The aim of this study was to investigate the differential improvement in patient-reported outcomes after PCI in focal and diffuse CAD as defined by the pullback pressure gradient (PPG).<br /><b>Methods</b><br />This is a subanalysis of the TARGET-FFR (Trial of Angiography vs. pressure-Ratio-Guided Enhancement Techniques-Fractional Flow Reserve) randomized clinical trial. The 7-item Seattle Angina Questionnaire (SAQ-7) was administered at baseline and 3 months after PCI. The PPG index was calculated from manual pre-PCI FFR pullbacks. The median PPG value was used to define focal and diffuse CAD. Residual angina was defined as an SAQ-7 score <100.<br /><b>Results</b><br />A total of 103 patients were analyzed. There were no differences in the baseline characteristics between patients with focal and diffuse CAD. Focal disease had larger increases in FFR after PCI than patients with diffuse disease (0.30 ± 0.14 vs 0.19 ± 0.12; P < 0.001). Patients with focal disease who underwent PCI for focal CAD had significantly higher SAQ-7 summary scores at follow-up than those with diffuse CAD (87.1 ± 20.3 vs 75.6 ± 24.4; mean difference = 11.5 [95% CI: 2.8-20.3]; P = 0.01). After PCI, residual angina was present in 39.8% but was significantly less in those with treated focal CAD (27.5% vs 51.9%; P = 0.020).<br /><b>Conclusions</b><br />Residual angina after PCI was almost twice as common in patients with a low PPG (diffuse disease), whereas patients with a high PPG (focal disease) reported greater improvement in angina and quality of life. The baseline pattern of CAD can predict the likelihood of angina relief. (Trial of Angiography vs. pressure-Ratio-Guided Enhancement Techniques-Fractional Flow Reserve [TARGET-FFR]; NCT03259815).<br /><br />Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 26 Dec 2022; 15:2506-2518</small></div>
Collet C, Collison D, Mizukami T, McCartney P, ... De Bruyne B, Oldroyd K
JACC Cardiovasc Interv: 26 Dec 2022; 15:2506-2518 | PMID: 36543445
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<div><h4>Early Outcomes of 2 Mitral Valve Transcatheter Leaflet Approximation Devices: A Propensity Score-Matched Multicenter Comparison.</h4><i>Mauri V, Sugiura A, Spieker M, Iliadis C, ... Lurz P, Pfister R</i><br /><b>Background</b><br />In addition to the edge-to-edge MitraClip repair system, the edge-to-spacer PASCAL repair system was approved for percutaneous treatment of severe mitral regurgitation (MR). Comparative data are lacking.<br /><b>Objectives</b><br />The aim of this study was to compare procedural and short-term safety and efficacy of 2 leaflet-based transcatheter mitral valve repair systems.<br /><b>Methods</b><br />Procedural and 30-day outcomes were investigated in a propensity score-matched cohort of 307 PASCAL and 307 MitraClip patients at 10 sites. Matching criteria included sex, age, left ventricular ejection fraction, New York Heart Association functional class, MR etiology, left ventricular end-diastolic diameter, left atrial volume index, and vena contracta width. The primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE).<br /><b>Results</b><br />Technical success was 97.0% in the PASCAL group and 98.0% in the MitraClip group (P = 0.624). MR ≤2+ at discharge was comparable in both groups (PASCAL: 93.8% vs MitraClip: 92.4%; P = 0.527), with more patients exhibiting MR ≤1+ in the PASCAL group (70.5% vs 56.6%; P < 0.001). The postprocedural mean gradient was significantly higher in the MitraClip group (3.3 ± 1.5 mm Hg vs 3.9 ± 1.7 mm Hg; P < 0.001). At 30 days, all-cause mortality and MAE rates were similar (mortality: 1.7% vs 3.3%; P = 0.299; MAE: 3.9% vs 5.2%; P = 0.562).<br /><b>Conclusions</b><br />In this first large propensity score-matched comparison, procedural success rates and MAE did not differ significantly between patients treated with the PASCAL or MitraClip valve repair system. Procedural results with less than moderate MR and no elevated transmitral gradient were more common in the PASCAL group, which might have an impact on long-term outcome.<br /><br />Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 26 Dec 2022; 15:2541-2551</small></div>
Mauri V, Sugiura A, Spieker M, Iliadis C, ... Lurz P, Pfister R
JACC Cardiovasc Interv: 26 Dec 2022; 15:2541-2551 | PMID: 36543448
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<div><h4>Mitral Valve Transcatheter Edge-to-Edge Repair Using MitraClip or PASCAL: A Multicenter Propensity Score-Matched Comparison.</h4><i>Schneider L, Markovic S, Mueller K, Felbel D, ... Rottbauer W, Keßler M</i><br /><b>Background</b><br />Since its introduction in 2003, Abbott\'s MitraClip (MC) has become the most established catheter-based treatment for mitral regurgitation (MR). Recent approval of Edwards Lifescience\'s PASCAL device has extended the field of TEER.<br /><b>Objectives</b><br />The aim of this retrospective multicenter study was to compare the PASCAL and MC regarding procedural results and short- and long-term outcomes after mitral valve transcatheter edge-to-edge repair (TEER).<br /><b>Methods</b><br />Data from 3 high-volume centers were analyzed. The primary endpoint was residual MR at discharge. Secondary endpoints were technical success, MR reduction, and 30-day mortality. After 1 year, all-cause mortality and residual MR were reported.<br /><b>Results</b><br />A total of 412 patients (216 MC, 196 PASCAL) treated between 2018 and 2020 were included. A total of 184 patients (92 in each treatment group) remained after propensity score matching. The rate of baseline MR ≥3 was 98.9% in both groups (P = 1.00). Both TEER systems achieved equally high technical success rates (97.8%; P = 1.00), resulting in residual MR ≤1 in 69.6% vs 77.1% of patients (P = 0.24) and MR reduction by ≥2 grades in 83.7% vs 92.4% of patients (P = 0.13) using the MC and PASCAL, respectively. Thirty-day mortality was 1.1% in both cohorts (P = 0.98), and 1-year follow-up showed similar MR reductions (residual MR ≤1, 78.0% with MC vs 82.3% with PASCAL; P = 0.70) and comparable all-cause mortality (14.1% with MC vs 6.5% with PASCAL; P = 0.14). In multivariate regression analysis, Society of Thoracic Surgeons score independently correlated with an optimal result (MR ≤1), while device choice did not show a significant impact.<br /><b>Conclusions</b><br />In this retrospective multicenter study, the established MC and the novel PASCAL mitral valve TEER systems were safe and offered excellent performance with comparable short- and long-term outcomes.<br /><br />Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 26 Dec 2022; 15:2554-2567</small></div>
Schneider L, Markovic S, Mueller K, Felbel D, ... Rottbauer W, Keßler M
JACC Cardiovasc Interv: 26 Dec 2022; 15:2554-2567 | PMID: 36543450
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<div><h4>Aortic Annulus S-Curve: Implications for Transcatheter Aortic Valve Replacement and Related Procedures, Part 1.</h4><i>Zgheib A, Campens L, Abualsaud A, Al Isma\'ili A, ... De Backer O, Piazza N</i><br /><AbstractText>Most transcatheter aortic valve replacement-related procedures (eg, transcatheter aortic valve replacement implantation depth, commissural alignment, coronary access, bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction, paravalvular leak closure) require an optimal fluoroscopic viewing angle located somewhere along the aortic annulus S-curve. Chamber views, coronary cusp and coronary anatomy, can be understood along the aortic annulus S-curve. A better understanding of the optimal fluoroscopic viewing angles along the S-curve may translate into increased operator confidence and improved safety and efficacy while reducing procedural time, radiation dose, contrast volume, and complication rates.</AbstractText><br /><br />Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 12 Dec 2022; 15:2353-2373</small></div>
Zgheib A, Campens L, Abualsaud A, Al Isma'ili A, ... De Backer O, Piazza N
JACC Cardiovasc Interv: 12 Dec 2022; 15:2353-2373 | PMID: 36480983
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<div><h4>Quantification of Commissural Alignment of Balloon-Expandable THV on Fluoroscopy: A Comparison Study With Post-TAVR CT.</h4><i>Akodad M, Tzimas G, Meier D, Haugan D, ... Webb JG, Blanke P</i><br /><b>Background</b><br />Coronary access may be challenging following transcatheter aortic valve replacement (TAVR) in the setting of transcatheter heart valve (THV) commissural misalignment.<br /><b>Objectives</b><br />The authors aimed to quantify the degree of commissural alignment following balloon-expandable THV implantation using a fluoroscopy-based trigonometric approach and assess its correlation with post-TAVR computed tomography (CT).<br /><b>Methods</b><br />Twenty patients who had undergone both TAVR with the balloon-expandable SAPIEN 3 THV and post-TAVR CT were included in the analysis. Optimized, predeployment 3-cusp angiographic view and postdeployment angiographic view using identical fluoroscopic projections were required. The distance between the most central posterior commissural strut and the THV centerline was assessed. Commissural alignment was calculated by means of a trigonometrical approach using an arcsine function, assuming circular deployment of the THV. Commissural alignment was stratified using a 4-tier scale: aligned (0° to 15°); mildly misaligned (15° to 30°); moderately misaligned (30° to 45°), and severely misaligned (45° to 60°).<br /><b>Results</b><br />Seven patients (35.0%) were misclassified by 1 tier, and no patient was misclassified by 2 or more tiers, with strong agreement between CT and fluoroscopy (weighted Cohen\'s kappa coefficient = 0.724). Correlation of the commissural offset angle determined from fluoroscopy and CT was excellent (r = 0.986; 95% CI: 0.965 to 0.995). Bland-Altman analysis demonstrated a strong agreement between both modalities with a mean difference of 0.5° (95% limits of agreement: -12.7° to 13.7°).<br /><b>Conclusions</b><br />The degree of commissural alignment of the balloon-expandable THV can be reliably assessed and quantified on postdeployment fluoroscopy using a standardized 3-cusp view and trigonometry-based analysis.<br /><br />Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 12 Dec 2022; 15:2374-2383</small></div>
Akodad M, Tzimas G, Meier D, Haugan D, ... Webb JG, Blanke P
JACC Cardiovasc Interv: 12 Dec 2022; 15:2374-2383 | PMID: 36480984
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<div><h4>P2Y Inhibitor or Aspirin Following Dual Antiplatelet Therapy After Percutaneous Coronary Intervention: A Network Meta-Analysis.</h4><i>Andò G, De Santis GA, Greco A, Pistelli L, ... De Caterina R, Capranzano P</i><br /><b>Background</b><br />It is still unknown which antiplatelet monotherapy should be continued after a period of dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention (PCI).<br /><b>Objectives</b><br />The aim of this study was to compare aspirin vs P2Y<sub>12</sub> inhibitor (P2Y<sub>12</sub>-I) monotherapy after dual antiplatelet therapy (DAPT) discontinuation in patients undergoing percutaneous coronary intervention (PCI).<br /><b>Methods</b><br />Randomized studies enrolling patients undergoing PCI with second-generation drug-eluting stents and comparing aspirin or P2Y<sub>12</sub>-I monotherapy after DAPT discontinuation vs prolonged DAPT or aspirin vs P2Y<sub>12</sub>-I monotherapy after DAPT were included. Primary efficacy and safety endpoints were myocardial infarction (MI) and major bleeding (MB), respectively. Point estimates for dichotomous outcomes were pooled using frequentist and Bayesian frameworks. Sensitivity analyses and treatment hierarchy were performed.<br /><b>Results</b><br />Nineteen studies encompassing 73,126 patients were included. The transitivity assumption was met. Under the frequentist framework, patients receiving aspirin had a significantly higher risk for MI compared with P2Y<sub>12</sub>-I monotherapy (risk ratio: 1.32; 95% CI: 1.08-1.62). Compared with DAPT, both monotherapies reduced MB, but only P2Y<sub>12</sub>-I showed equivalent efficacy in preventing MI. No significant differences in MB, death, and other thrombotic outcomes were observed. However, point estimates for the risk for stent thrombosis and stroke favored P2Y<sub>12</sub>-I monotherapy. Consistent results were found in a fixed-effects model and the Bayesian framework, with all models having adequate convergence. P2Y<sub>12</sub>-I vs aspirin monotherapy had the highest probability of being ranked first for reduction of all assessed outcomes.<br /><b>Conclusions</b><br />P2Y<sub>12</sub>-I monotherapy following DAPT discontinuation after PCI is associated with a significantly lower risk for MI and similar risk for MB, suggesting a potentially relevant net clinical benefit vs aspirin monotherapy. These findings strengthen the rationale for further studies directly comparing the 2 monotherapies after DAPT in PCI patients.<br /><br />Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 28 Nov 2022; 15:2239-2249</small></div>
Andò G, De Santis GA, Greco A, Pistelli L, ... De Caterina R, Capranzano P
JACC Cardiovasc Interv: 28 Nov 2022; 15:2239-2249 | PMID: 36423966
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<div><h4>Platelet Reactivity and Clinical Outcomes After Drug-Eluting Stent Implantation: Results From the PTRG-DES Consortium.</h4><i>Lee SJ, Cha JJ, Jeong YH, Hong SJ, ... Kim BK, PTRG Investigators</i><br /><b>Background</b><br />The long-term prognostic implication of platelet reactivity after percutaneous coronary intervention (PCI) is not clearly known.<br /><b>Objectives</b><br />The impacts of platelet reactivity from the PTRG-DES consortium were assessed.<br /><b>Methods</b><br />The primary endpoint was the major adverse cardiac and cerebrovascular events (MACCE) including all-cause death, myocardial infarction, stent thrombosis, or stroke. Key secondary endpoints were all-cause mortality, major bleeding, and net adverse clinical events (NACE), including MACCE and bleeding.<br /><b>Results</b><br />Between 2003 and 2018, a total of 11,714 patients were enrolled and grouped into tertiles according to P2Y<sub>12</sub> reaction units (PRUs): high PRUs (≥253), intermediate PRUs (188-252), and low PRUs (<188). The Kaplan-Meier (KM) estimates of the primary outcome were significantly different across the groups; the high-PRU group showed the highest MACCE rate at 5 years (12.9%, 11.1%, and 7.0% in high-, intermediate-, and low-PRU groups, respectively; P < 0.001), as well as at 1 year (P < 0.001). The high-PRU group had the greatest KM estimates of all-cause death (8.2%, 5.9%, and 3.7%, respectively; P < 0.001) at 5 years without significant differences of major bleeding, and resultant of a higher KM estimates of NACE (15.7%, 13.6%, and 9.7%, respectively; P < 0.001). A PRU ≥252, the best cutoff value, was strongly related to MACCE (HR: 1.39; 95% CI: 1.11-1.74; P = 0.003) and all-cause death at 5 years after PCI (HR: 1.42; 95% CI: 1.04-1.94; P = 0.026). The optimal cutoff value of aspirin reaction units predicting the MACCE occurrence was ≥414 and was significantly associated with 5-year MACCE occurrence or all-cause death (P < 0.001).<br /><b>Conclusions</b><br />In this large-scale cohort, high PRU was significantly associated with occurrence of MACCE, all-death death, and NACE at 5 years, as well as 1 year after PCI. (PTRG-DES Consortium [PTRG]; NCT04734028).<br /><br />Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 28 Nov 2022; 15:2253-2265</small></div>
Lee SJ, Cha JJ, Jeong YH, Hong SJ, ... Kim BK, PTRG Investigators
JACC Cardiovasc Interv: 28 Nov 2022; 15:2253-2265 | PMID: 36423968
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<div><h4>Ticagrelor vs Prasugrel in a Contemporary Real-World Cohort Undergoing Percutaneous Coronary Intervention.</h4><i>Koshy AN, Giustino G, Sartori S, Kyaw H, ... Mehran R, Sharma SK</i><br /><b>Background</b><br />Potent P2Y<sub>12</sub> agents such as ticagrelor and prasugrel are increasingly utilized across the clinical spectrum of patients undergoing percutaneous coronary intervention (PCI). There is a paucity of data supporting their use in a patient population inclusive of both acute coronary syndrome (ACS) and chronic coronary syndrome (CCS) patients.<br /><b>Objectives</b><br />The authors compared the efficacy and safety of ticagrelor and prasugrel in a real-world contemporary PCI cohort.<br /><b>Methods</b><br />Consecutive patients undergoing PCI between 2014 and 2019 discharged on either prasugrel or ticagrelor were included from the prospectively collected institutional PCI registry. Primary endpoint was the composite of death and myocardial infarction (MI), with secondary outcomes including rates of bleeding, stroke, and target vessel revascularization at 1 year.<br /><b>Results</b><br />Overall, 3,858 patients were included in the study (ticagrelor: n = 2,771; prasugrel: n = 1,087), and a majority (48.4%) underwent PCI in the context of CCS. Patients prescribed ticagrelor were more likely to be female, have a history of cerebrovascular disease, and have ACS presentation, while those receiving prasugrel were more likely to be White with a higher prevalence of prior revascularization. No difference in the risk of death or MI was noted across the groups (ticagrelor vs prasugrel: 3.3% vs 3.1%; HR: 0.88; 95% CI: 0.54-1.43; P = 0.59). Rates of target vessel revascularization were significantly lower in the ticagrelor cohort (9.3% vs 14.0%; adjusted HR: 0.71; 95% CI: 0.55-0.91; P = 0.007) with no differences in stroke or bleeding. The results were consistent in patients with CCS (HR: 0.84; 95% CI: 0.46-1.54) and ACS (HR: 1.18; 95% CI: 0.46-1.54), without evidence of interaction (P = 0.37), and confirmed across multivariable adjustment and propensity score stratification analysis.<br /><b>Conclusions</b><br />In this contemporary patient population undergoing PCI, prasugrel and ticagrelor were associated with similar 1-year efficacy and safety.<br /><br />Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 28 Nov 2022; 15:2270-2280</small></div>
Koshy AN, Giustino G, Sartori S, Kyaw H, ... Mehran R, Sharma SK
JACC Cardiovasc Interv: 28 Nov 2022; 15:2270-2280 | PMID: 36423970
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<div><h4>Use of the Limited Antegrade Subintimal Tracking Technique in Chronic Total Occlusion Percutaneous Coronary Intervention.</h4><i>Karacsonyi J, Kostantinis S, Simsek B, Alaswad K, ... Burke MN, Brilakis ES</i><br /><b>Background</b><br />There are limited data on the limited antegrade subintimal tracking (LAST) technique for chronic total occlusion (CTO) percutaneous coronary intervention (PCI).<br /><b>Objectives</b><br />The aim of this study was to analyze the frequency of use and outcomes of the LAST technique for CTO PCI.<br /><b>Methods</b><br />We analyzed 2,177 CTO PCIs performed using antegrade dissection and re-entry (ADR) in the PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) registry between 2012 and January 2022 at 39 centers. ADR was attempted in 1,465 cases (67.3%).<br /><b>Results</b><br />Among antegrade re-entry cases, LAST was used in 163 (11.1%) (primary LAST in 127 [8.7%] and secondary LAST [LAST after other ADR approaches failed] in 36 [2.5%]), the Stingray system (Boston Scientific) in 980 (66.9%), subintimal tracking and re-entry in 387 (26.4%), and contrast-guided subintimal tracking and re-entry in 29 (2.0%). The mean patient age was 65.2 ± 10 years, and 85.8% were men. There was no significant difference in technical (71.8% vs 77.8%; P = 0.080) and procedural (69.9% vs 75.3%; P = 0.127) success and major cardiac adverse events (1.84% vs 3.53%; P = 0.254) between LAST and non-LAST cases. However, on multivariable analysis, the use of LAST was associated with lower procedural success (OR: 0.61; 95% CI: 0.41-0.91). Primary LAST was associated with higher technical (76.4% vs 55.6%; P = 0.014) and procedural (75.6% vs 50.0%; P = 0.003) success and similar major adverse cardiac event (1.57% vs 2.78%; P = 0.636) rates compared with secondary LAST.<br /><b>Conclusions</b><br />LAST was used in 11.1% of antegrade re-entry CTO PCI cases and was associated with lower procedural success on multivariable analysis, suggesting a limited role of LAST in contemporary CTO PCI.<br /><br />Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 28 Nov 2022; 15:2284-2293</small></div>
Karacsonyi J, Kostantinis S, Simsek B, Alaswad K, ... Burke MN, Brilakis ES
JACC Cardiovasc Interv: 28 Nov 2022; 15:2284-2293 | PMID: 36423972
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<div><h4>Distal vs Conventional Radial Access for Coronary Angiography and/or Intervention: A Meta-Analysis of Randomized Trials.</h4><i>Ferrante G, Condello F, Rao SV, Maurina M, ... Bertrand O, Valgimigli M</i><br /><b>Background</b><br />Emerging evidence from randomized clinical trials (RCTs) comparing distal radial access (DRA) with conventional radial access (RA) is available.<br /><b>Objectives</b><br />The aim of this study was to provide a quantitative appraisal of the effects of DRA) vs conventional RA for coronary angiography with or without intervention.<br /><b>Methods</b><br />The PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases were searched for RCT comparing DRA vs conventional RA for coronary angiography and/or intervention. Data were pooled by meta-analysis using a random-effects model. The primary endpoint was radial artery occlusion (RAO) at the longest available follow-up.<br /><b>Results</b><br />Fourteen studies enrolling 6,208 participants were included. Compared with conventional RA, DRA was associated with a significant lower risk of RAO, either detected at latest follow-up (risk ratio [RR]: 0.36; 95% CI: 0.23-0.56; P < 0.001; number needed to treat [NNT] = 30) or in-hospital (RR: 0.32; 95% CI: 0.19-0.53; P < 0.001; NNT = 28), as well as EASY (Early Discharge After Transradial Stenting of Coronary Arteries) ≥II hematoma (RR: 0.51; 95% CI: 0.27-0.96; P = 0.04; NNT = 107). By contrast, DRA was associated with a higher risk of access site crossover (RR: 3.08; 95% CI: 1.88-5.06; P < 0.001; NNT = 12), a longer time for radial puncture (standardized mean difference [SMD]: 3.56; 95% CI: 0.96-6.16; P < 0.001), a longer time for sheath insertion (SMD: 0.37; 95% CI: 0.16-0.58; P < 0.001), and a higher number of puncture attempts (SMD: 0.59, 95% CI: 0.48-0.69; P < 0.001).<br /><b>Conclusions</b><br />Compared with conventional RA, DRA is associated with lower risks of RAO and EASY ≥II hematoma but requires longer time for radial artery cannulation and sheath insertion, more puncture attempts, and a higher access site crossover.<br /><br />Copyright © 2022 American College of Cardiology Foundation. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 28 Nov 2022; 15:2297-2311</small></div>
Ferrante G, Condello F, Rao SV, Maurina M, ... Bertrand O, Valgimigli M
JACC Cardiovasc Interv: 28 Nov 2022; 15:2297-2311 | PMID: 36423974
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<div><h4>The Effect of Psychosocial Risk Factors on Outcomes After Aortic Valve Replacement.</h4><i>Newell P, Zogg C, Shirley H, Feliz J, ... Shah P, Kaneko T</i><br /><b>Background</b><br />Psychosocial risk factors (PSRFs) have emerged as important nontraditional risk factors that are associated with worse surgical outcomes but have not been well-characterized in valvular disease.<br /><b>Objectives</b><br />This study evaluates the impact of PSRFs on 30-day outcomes following surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR).<br /><b>Methods</b><br />All adult patients (≥18 years of age) who underwent isolated TAVR or SAVR in the Nationwide Readmissions Database from 2016 to 2018 were included. Patients were classified as having 0 PSRFs vs ≥1 PSRF. PSRFs included limited cognitive understanding, substance use, psychiatric disease, low socioeconomic status, or uninsured status. Primary outcomes included 30-day mortality, readmission, and composite morbidity (stroke, pulmonary embolus, pacemaker implantation, bleeding complications, acute kidney injury, myocardial infarction, or new atrial fibrillation).<br /><b>Results</b><br />A nationally weighted total of 74,763 SAVR and 87,142 TAVR patients met inclusion criteria. For SAVR, patients with PSRFs had significantly higher 30-day mortality (4.2% vs 3.7%; P = 0.048) and readmissions (13.1% vs 11.3%; P < 0.001), but there was no difference in composite morbidity. For TAVR, patients with PSRFs had significantly higher 30-day readmission (11.7% vs 10.7%; P = 0.012) but no difference in 30-day mortality or composite morbidity. On risk-adjusted analysis, presence of PSRFs was a significant predictor of higher 30-day readmissions following SAVR (adjusted OR: 1.10; 95% CI: 1.02-1.19).<br /><b>Conclusions</b><br />The presence of PSRFs is associated with worse short-term outcomes following SAVR and TAVR, with a more profound impact in SAVR. This study highlights the importance of identifying at-risk patients and suggests that TAVR may be beneficial in patients with less social support.<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>JACC Cardiovasc Interv: 28 Nov 2022; 15:2326-2335</small></div>
Newell P, Zogg C, Shirley H, Feliz J, ... Shah P, Kaneko T
JACC Cardiovasc Interv: 28 Nov 2022; 15:2326-2335 | PMID: 36423976
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<div><h4>Comparative Safety of Transcatheter LAAO With the First-Generation Watchman and Next-Generation Watchman FLX Devices.</h4><i>Price MJ, Friedman DJ, Du C, Wang Y, ... Curtis JP, Freeman JV</i><br /><b>Background</b><br />Procedural complications limit the clinical benefit of transcatheter left atrial appendage occlusion (LAAO). Next-generation devices incorporate design modifications intended to improve procedural safety, but their clinical impact has not been described.<br /><b>Objectives</b><br />The aim of this study was to compare in-hospital outcomes for the Watchman FLX with the predicate Watchman 2.5 device.<br /><b>Methods</b><br />The National Cardiovascular Data Registry LAAO Registry was used to identify patients who received the Watchman FLX and an identical number of patients receiving the Watchman 2.5 at the same sites directly preceding the first Watchman FLX case at each site. The primary endpoint was in-hospital major adverse events (MAE), defined as a composite of death, cardiac arrest, stroke, transient ischemic attack, intracranial hemorrhage, systemic arterial embolism, major bleeding, major vascular complication, myocardial infarction, pericardial effusion requiring intervention (percutaneous or surgical), and device embolization. A secondary analysis was performed using 2:1 propensity score matching of patients receiving the Watchman 2.5 or Watchman FLX.<br /><b>Results</b><br />The study cohort consisted of 27,013 patients receiving each device. The rate of in-hospital MAE was significantly lower for the Watchman FLX compared with the Watchman 2.5 (1.35% vs 2.40%; adjusted OR: 0.57; 95% CI: 0.50-0.65; P < 0.0001), driven largely by fewer pericardial effusions requiring intervention (0.42% vs 1.23%; adjusted OR: 0.34; 95% CI: 0.28-0.42; P < 0.0001). The Watchman FLX was also associated with significant lower rates of the individual endpoints of in-hospital mortality (0.12% vs 0.24%; P < 0.0001), major bleeding (1.08% vs 2.05%; P < 0.0001), cardiac arrest (0.13% vs 0.24%; P = 0.006), and device embolization (0.02% vs 0.06%; P = 0.028), while myocardial infarction, stroke, and major vascular complications did not differ between groups. Propensity score matching analysis demonstrated similar results, with lower rates of MAE with the Watchman FLX (1.34% vs 2.58%; OR: 0.51; 95% CI: 0.46-0.58; P < 0.0001).<br /><b>Conclusions</b><br />Transcatheter LAAO with the Watchman FLX was associated with lower rates of in-hospital MAE compared with the predicate Watchman device, including mortality, pericardial effusion, major bleeding, cardiac arrest, and device embolization. This may favorably influence the balance of risks and benefits of transcatheter LAAO for stroke prevention in patients with atrial fibrillation.<br /><br />Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 14 Nov 2022; 15:2115-2123</small></div>
Price MJ, Friedman DJ, Du C, Wang Y, ... Curtis JP, Freeman JV
JACC Cardiovasc Interv: 14 Nov 2022; 15:2115-2123 | PMID: 36357014
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<div><h4>Peridevice Leak After Transcatheter Left Atrial Appendage Occlusion: An Analysis of the Amulet IDE Trial.</h4><i>Price MJ, Ellis CR, Nielsen-Kudsk JE, Thaler D, ... Gage R, Lakkireddy D</i><br /><b>Background</b><br />Peridevice leak (PDL) is a limitation of left atrial appendage occlusion.<br /><b>Objectives</b><br />The aim of this study was to assess the incidence of and outcomes associated with PDL in the Amulet IDE (AMPLATZER™ Amulet™ LAA Occluder Trial) randomized controlled trial.<br /><b>Methods</b><br />Patients with atrial fibrillation at increased stroke risk were randomly assigned to undergo either Amulet (dual occlusive mechanism) or Watchman 2.5 (single occlusive mechanism) device implantation. Transesophageal echocardiography was performed at 45 days and 12 months postprocedure. Clinically significant PDL was defined as ≥3 mm. The primary endpoint was ischemic stroke or systemic embolism, and the secondary endpoint was stroke, systemic embolism, or cardiovascular death. The Kaplan-Meier method was used to estimate 18-month cumulative event rates landmarked at day 45 postprocedure.<br /><b>Results</b><br />A total of 1,593 patients underwent successful left atrial appendage occlusion and had an evaluable transesophageal echocardiographic studies at 45 days. The dual-occlusive mechanism device provided superior closure (defined as leak <3 mm) compared with the single-occlusive mechanism device at 45 days (88.9% vs 74.1%; P < 0.01) and 12 months (90.5% vs. 78.3%; P < 0.01). Through 18 months, PDL was associated with a higher, but not statistically significant, risk for the primary endpoint (3.6% vs 1.8%; adjusted HR: 1.98; 95% CI: 0.93-4.19; P = 0.07) and a statistically significantly higher risk for the secondary endpoint (8.1% vs. 4.7%; adjusted HR: 1.66; 95% CI: 1.02-2.69; P = 0.04).<br /><b>Conclusions</b><br />The dual-occlusive mechanism device provided superior closure compared with the single-occlusive mechanism device at both 45 days and 1 year postprocedure. PDL ≥3 mm was associated with a significantly increased 18-month risk for the composite of stroke, systemic embolism, or cardiovascular death. Completeness of closure of the left atrial appendage has important implications for patient outcomes. (AMPLATZER™ Amulet™ LAA Occluder Trial [Amulet IDE]; NCT02879448).<br /><br />Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 14 Nov 2022; 15:2127-2138</small></div>
Price MJ, Ellis CR, Nielsen-Kudsk JE, Thaler D, ... Gage R, Lakkireddy D
JACC Cardiovasc Interv: 14 Nov 2022; 15:2127-2138 | PMID: 36357016
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<div><h4>Sex Differences in Safety and Effectiveness of LAAO: Insights From the Amulet IDE Trial.</h4><i>Alkhouli M, Russo AM, Thaler D, Windecker S, ... Gage R, Lakkireddy D</i><br /><b>Background</b><br />Women have higher rates of acute complications after left atrial appendage occlusion (LAAO). However, data on long-term safety and effectiveness are limited.<br /><b>Objectives</b><br />The aim of this study was to examine sex-specific short- and long-term outcomes after LAAO in the Amulet IDE (Amplatzer™ Amulet™ LAA Occluder) trial.<br /><b>Methods</b><br />The following outcomes were compared between men and women: in-hospital complications, device-related outcomes (peridevice leak at 45 days and device-related thrombus at 18 months), and long-term clinical outcomes (death, thromboembolism, and bleeding). Subanalyses for the interaction between sex and device type were performed.<br /><b>Results</b><br />A total of 1,833 patients underwent attempted device implantation (917 with the Amulet and 916 with the Watchman), of whom 734 were women (40%). Device success was 97.4% in men and 97.1% in women (P = 0.60). Rates of major in-hospital adverse events were higher in women (4.4% vs 1.9%; P < 0.01), driven by major bleeding (3.7% vs 1.0%; P < 0.01) and pericardial effusion requiring intervention (2.0% vs 0.5%; P < 0.01). Peridevice leak and device-related thrombus were similar in men and women (18.3% vs 18.9% [P = 0.78] and 3.3% vs 5.0% [P = 0.10], respectively). There were no differences between men and women in rates of ischemic stroke or systemic embolism (2.6% vs 2.6%; P = 0.98), transient ischemic attack (1.3% vs 1.6%; P = 0.69), hemorrhagic stroke (0.5% vs 0.4%; P = 0.88), major bleeding (10.1% vs 10.9%; P = 0.49), cardiovascular death (4.3% vs 3.5%; P = 0.45), or all-cause death (8.9% vs 6.9%; P = 0.16).<br /><b>Conclusions</b><br />In the Amulet IDE trial, long-term clinical outcomes including effectiveness following LAAO were comparable in men and women despite the higher rates of in-hospital complications due to major bleeding and pericardial effusion in women. (Amplatzer™ Amulet™ LAA Occluder Trial [Amulet IDE]; NCT02879448).<br /><br />Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 14 Nov 2022; 15:2143-2155</small></div>
Alkhouli M, Russo AM, Thaler D, Windecker S, ... Gage R, Lakkireddy D
JACC Cardiovasc Interv: 14 Nov 2022; 15:2143-2155 | PMID: 36357018
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<div><h4>Evaluation of Multimodality LAA Leak Closure Methods Following Incomplete Occlusion: The LAA Leak Study.</h4><i>Charate R, Ahmed A, Della Rocca DG, Bloom S, ... Natale A, Lakkireddy D</i><br /><b>Background</b><br />Incomplete left atrial appendage (LAA) closure is an evolving topic of clinical significance and thromboembolic potential, with recent long-term studies suggesting lower cutoffs for relevant leak size.<br /><b>Objectives</b><br />The aim of this prospective observational study was to assess 3 different closure techniques for persistent peridevice leaks after incomplete LAA closure and compare their efficacy and safety outcomes.<br /><b>Methods</b><br />We studied 160 patients (mean age 72 ± 9 years; 71% men) who underwent 1 of the 3 available modalities (detachable embolization coils, vascular plugs or septal occluders, and radiofrequency ablation) for residual central or eccentric leak closure. Both acute postprocedural success (closure or <1-mm leak at the end of the procedure) and closure at 1-year follow-up transesophageal echocardiography imaging were evaluated.<br /><b>Results</b><br />Of 160 patients, 0.6%, 41.3%, and 58.1% had mild (1-2 mm), moderate (3-5 mm), and severe (≥5 mm) leaks, respectively. Baseline LAA closure type was 72.5% Watchman FLX, 16.3% Lariat, 5.6% surgical ligation, 1.9% AtriClip, and 1.9% Amulet. Successful closure (0- or <1-mm leak) was seen in 100% of patients in all cohorts following intervention, with overall complete closure (0-1 mm) or mild or minimal leaks (1-2 mm) on 1-year follow-up transesophageal echocardiography seen in 100% of the atrial septal occluder or vascular plug cohort, 85.9% of the coil cohort, and 83.3% of the radiofrequency ablation cohort (P < 0.001). Two patients (1.3%) experienced cardiac tamponade, and there were no deaths or other complications.<br /><b>Conclusions</b><br />Peridevice leaks can safely and effectively be closed using 3 different modalities depending on size and location.<br /><br />Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 14 Nov 2022; 15:2158-2170</small></div>
Charate R, Ahmed A, Della Rocca DG, Bloom S, ... Natale A, Lakkireddy D
JACC Cardiovasc Interv: 14 Nov 2022; 15:2158-2170 | PMID: 36357020
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<div><h4>Functional Patterns of Coronary Disease: Diffuse, Focal, and Serial Lesions.</h4><i>Scarsini R, Fezzi S, Leone AM, De Maria GL, ... Wijns W, Ribichini FL</i><br /><AbstractText>The physiological assessment of coronary lesions is influenced by the pattern and distribution of coronary artery disease (CAD), including focal lesions, serial lesions, diffuse disease, and mixed patterns. These various patterns of CAD impact the accuracy of pressure wire and angiography-derived physiology indexes, and diffuse disease in particular is an important determinant of the anticipated outcome of percutaneous coronary intervention. Therefore, identification of the physiological pattern of disease provides relevant information for the management of CAD and percutaneous coronary intervention procedural planning. At present, the classification of physiological patterns and its implications for the tailored management of a patient with CAD are poorly defined. This state-of-the-art review provides an overview of the available evidence on functional patterns of CAD with a special focus on their diagnostic and therapeutic implications. It also aims to provide clear definitions of physiological patterns of CAD based on the available evidence and expert opinion. A practical algorithm is provided to optimize the use of pressure wire and angiography-derived indexes of coronary physiology in the settings of focal, serial, and diffuse lesions, with the addition of intracoronary imaging in selected cases.</AbstractText><br /><br />Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 14 Nov 2022; 15:2174-2191</small></div>
Scarsini R, Fezzi S, Leone AM, De Maria GL, ... Wijns W, Ribichini FL
JACC Cardiovasc Interv: 14 Nov 2022; 15:2174-2191 | PMID: 36357022
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<div><h4>Trans-Stent FFR Gradient as a Modifiable Integrant in Predicting Long-Term Target Vessel Failure.</h4><i>Uretsky BF, Agarwal SK, Vallurupalli S, Al-Hawwas M, ... Biscaglia S, Hakeem A</i><br /><b>Background</b><br />Fractional flow reserve (FFR) after percutaneous coronary intervention (PCI) is associated with long-term outcomes. Data relating FFR-based trans-stent gradient (TSG) after PCI to long-term outcomes are sparse.<br /><b>Objectives</b><br />The aim of this study was to test whether TSG is associated with adverse events at follow-up after PCI.<br /><b>Methods</b><br />Data were gathered from a prospective registry evaluating 501 vessels in 416 patients with median follow-up period of 596 days. Primary endpoints were: 1) target vessel failure (TVF), including target vessel revascularization, and target vessel myocardial infarction after discharge; and 2) major adverse cardiac events (MACE) including TVF, target vessel revascularization, nontarget vessel MI, cardiac death.<br /><b>Results</b><br />After PCI, median post-PCI FFR was 0.86 and median TSG was 0.04. TSG >0.04 was associated with increased rates of TVF (8.7% vs 2.9%; P = 0.014) and MACE (17.8% vs 9.2%; P = 0.02). Post-PCI FFR < 0.86 was associated with increased rates of TVF (6.1% vs 2.2%; P = 0.03) and MACE (16.5% vs 10%; P = 0.036). The vessel subgroup with high TSG and low FFR had significantly higher rates of TVF (10.2%; P = 0.02) and MACE (20.1%; P = 0.049) than vessels with: 1) high TSG and high FFR (TVF, 2.9%; MACE, 9.7%); 2) low TSG and low FFR (TVF, 3.8%; MACE, 11.3%); and 3) low TSG high FFR (TVF, 2.2%; MACE, 7.5%). In multivariate analysis, TSG was independently predictive of TVF.<br /><b>Conclusions</b><br />Higher TSG was an independent predictor of adverse events, particularly TVF, and identified a subgroup of patients at higher risk for poor outcomes. The combination of high TSG and low FFR showed significantly worse outcomes compared with an \"ideal result\" (high FFR and low TSG). These data support a recommendation to use TSG during FFR evaluation to determine the functional success of PCI.<br /><br />Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 14 Nov 2022; 15:2192-2202</small></div>
Uretsky BF, Agarwal SK, Vallurupalli S, Al-Hawwas M, ... Biscaglia S, Hakeem A
JACC Cardiovasc Interv: 14 Nov 2022; 15:2192-2202 | PMID: 36357023
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Abstract
<div><h4>Impact of Nonobstructive Left Main Coronary Artery Atherosclerosis on Long-Term Mortality.</h4><i>Noguchi M, Gkargkoulas F, Matsumura M, Kotinkaduwa LN, ... Mintz GS, Maehara A</i><br /><b>Background</b><br />Although the presence of severe stenosis in the left main coronary artery (LMCA) is a well-established predictor of mortality, whether this extends to nonobstructive atherosclerosis in the LMCA is unknown.<br /><b>Objectives</b><br />The aim of this study was to evaluate the association between LMCA disease by intravascular ultrasound (IVUS) and long-term mortality.<br /><b>Methods</b><br />Between 2005 and 2013, 3,239 patients with LMCA IVUS imaging without LMCA revascularization (either before angiography or scheduled based on index angiography or IVUS) were included. The primary and secondary endpoints were all-cause and cardiac mortality at a minimum of 5 years obtained from the National Death Index.<br /><b>Results</b><br />The IVUS-measured LMCA minimum lumen area (MLA) and plaque burden were 13.1 ± 5.0 mm<sup>2</sup> and 41.7% ± 15.6%, respectively. The median follow-up was 8.2 years. The Kaplan-Meier estimated 12-year all-cause and cardiac death rates were 37.5% and 17.0%, respectively. Greater plaque burden (unadjusted HR per 10%: 1.17; 95% CI: 1.12-1.22; P < 0.0001) and smaller IVUS MLA (unadjusted HR per 1 mm<sup>2</sup>: 0.98; 95% CI: 0.96-0.99; P = 0.0008) were associated with all-cause death. After adjusting for clinical, angiographic, and IVUS factors, plaque burden (adjusted HR per 10%: 1.12; 95% CI: 1.04-1.21; P = 0.003) but not MLA (adjusted HR per 1 mm<sup>2</sup>: 1.02; 95% CI: 0.99-1.04; P = 0.18) was associated with long-term all-cause death. These findings were also consistent for long-term cardiac mortality.<br /><b>Conclusions</b><br />In the present large-scale study with a 12-year follow-up, increasing LMCA plaque burden was associated with long-term all-cause and cardiac mortality in patients not undergoing LMCA revascularization, even when the lumen area was preserved.<br /><br />Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 14 Nov 2022; 15:2206-2217</small></div>
Noguchi M, Gkargkoulas F, Matsumura M, Kotinkaduwa LN, ... Mintz GS, Maehara A
JACC Cardiovasc Interv: 14 Nov 2022; 15:2206-2217 | PMID: 36357025
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Abstract
<div><h4>Hybrid Approach Using the Cusp-Overlap Technique for Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve.</h4><i>Akodad M, Blanke P, Nestelberger T, Alosail A, ... Wood DA, Webb JG</i><br /><b>Background</b><br />The cusp-overlap (CO) technique has recently been advocated and is being increasingly adopted for self-expandable transcatheter heart valve (THV) implantation.<br /><b>Objectives</b><br />The aim of this study was to evaluate the feasibility, implantation depth, and outcomes of the CO technique for the balloon-expandable SAPIEN 3 THV.<br /><b>Methods</b><br />The CO technique was used in consecutive patients undergoing balloon-expandable THV implantation at one center between April 2021 and March 2022. Optimal fluoroscopic angles were determined from preprocedural computed tomography and confirmed on predeployment angiography. The THV radiolucent line was positioned 2 to 4 mm below the noncoronary cusp in the CO view, and positioning was confirmed in the 3-cusp view. Postdeployment THV implantation depth was assessed in both views. One-month outcomes were assessed using Valve Academic Research Consortium 3 criteria.<br /><b>Results</b><br />Among 137 patients eligible for the CO technique, the CO view was not used because of unfavorable ergonomics in 27 patients (26.5%) and hemodynamic instability in 8 patients (7.8%). Among 102 patients, the mean age was 81.1 ± 6.6 years, the mean Society of Thoracic Surgeons score was 3.3% ± 2.2%, and 64.7% were men. The mean measured THV implantation depth was 3.0 ± 1.4 mm in the CO view and 2.5 ± 1.4 mm in the 3-cusp view. At 1-month follow-up, 1 patient (1.0%) had died, 1 (1.0%) had had a stroke, and 7 (6.8%) had undergone permanent pacemaker implantation.<br /><b>Conclusions</b><br />The CO technique is feasible and safe and may facilitate more accurate balloon-expandable THV positioning, especially when deep implantation needs to be avoided. Further studies are required to explore potential reduction in atrioventricular conduction block, pacemakers, or paravalvular regurgitation.<br /><br />Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 08 Nov 2022; epub ahead of print</small></div>
Akodad M, Blanke P, Nestelberger T, Alosail A, ... Wood DA, Webb JG
JACC Cardiovasc Interv: 08 Nov 2022; epub ahead of print | PMID: 36402718
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This program is still in alpha version.