<div><h4>Do PCI Facility Openings and Closures Affect AMI Outcomes Differently in High- vs Average-Capacity Markets?</h4><i>Shen YC, Krumholz HM, Hsia RY</i><br /><b>Background</b><br />Disparities in access to percutaneous coronary intervention (PCI) for patients with acute myocardial infarction may result from openings and closures of PCI-providing hospitals, potentially leading to low hospital PCI volume, which is associated with poor outcomes.<br /><b>Objectives</b><br />The authors sought to determine whether openings and closures of PCI hospitals have differentially impacted patient health outcomes in high- vs average-capacity PCI markets.<br /><b>Methods</b><br />In this retrospective cohort study, the authors identified PCI hospital availability within a 15-minute driving time of zip code communities. The authors categorized communities by baseline PCI capacity and identified changes in outcomes associated with PCI-providing hospital openings and closures using community fixed-effects regression models.<br /><b>Results</b><br />From 2006 to 2017, 20% and 16% of patients in average- and high-capacity markets, respectively, experienced a PCI hospital opening within a 15-minute drive. In average-capacity markets, openings were associated with a 2.6 percentage point decrease in admission to a high-volume PCI facility; high-capacity markets saw an 11.6 percentage point decrease. After an opening, patients in average-capacity markets experienced a 5.5% and 7.6% relative increase in likelihood of same-day and in-hospital revascularization, respectively, as well as a 2.5% decrease in mortality. PCI hospital closures were associated with a 10.4% relative increase in admission to high-volume PCI hospitals and a 1.4 percentage point decrease in receipt of same-day PCI. There was no change observed in high-capacity PCI markets.<br /><b>Conclusions</b><br />After openings, patients in average-capacity markets derived significant benefits, whereas those in high-capacity markets did not. This suggests that past a certain threshold, facility opening does not improve access and health outcomes.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 22 May 2023; 16:1129-1140</small></div>

<div><h4>Effects of Elective Coronary Revascularization vs Medical Therapy Alone on Noncardiac Mortality: A Meta-Analysis.</h4><i>Navarese EP, Lansky AJ, Farkouh ME, Grzelakowska K, ... Wijns W, Kereiakes DJ</i><br /><b>Background</b><br />Uncertainty exists whether coronary revascularization plus medical therapy (MT) is associated with an increase in noncardiac mortality in chronic coronary syndrome (CCS) when compared with MT alone, particularly following recent data from the ISCHEMIA-EXTEND (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial.<br /><b>Objectives</b><br />This study conducted a large-scale meta-analysis of trials comparing elective coronary revascularization plus MT vs MT alone in patients with CCS to determine whether revascularization has a differential impact on noncardiac mortality at the longest follow-up.<br /><b>Methods</b><br />We searched for randomized trials comparing revascularization plus MT vs MT alone in patients with CCS. Treatment effects were measured by rate ratios (RRs) with 95% CIs, using random-effects models. Noncardiac mortality was the prespecified endpoint. The study is registered with PROSPERO (CRD42022380664).<br /><b>Results</b><br />Eighteen trials were included involving 16,908 patients randomized to either revascularization plus MT (n = 8,665) or to MT alone (n = 8,243). No significant differences were detected in noncardiac mortality between the assigned treatment groups (RR: 1.09; 95% CI: 0.94-1.26; P = 0.26), with absent heterogeneity (I<sup>2</sup> = 0%). Results were consistent without the ISCHEMIA trial (RR: 1.00; 95% CI: 0.84-1.18; P = 0.97). By meta-regression, follow-up duration did not affect noncardiac death rates with revascularization plus MT vs MT alone (P = 0.52). Trial sequential analysis confirmed the reliability of meta-analysis, with the cumulative Z-curve of trial evidence within the nonsignificance area and reaching futility boundaries. Bayesian meta-analysis findings were consistent with the standard approach (RR: 1.08; 95% credible interval: 0.90-1.31).<br /><b>Conclusions</b><br />In patients with CCS, noncardiac mortality in late follow-up was similar for revascularization plus MT compared with MT alone.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 22 May 2023; 16:1144-1156</small></div>

<div><h4>Ventricular Remodeling and Outcomes After Mitral Transcatheter Edge-to-Edge Repair in Heart Failure: The COAPT Trial.</h4><i>Lindman BR, Asch FM, Grayburn PA, Mack MJ, ... Lindenfeld J, Stone GW</i><br /><b>Background</b><br />The relationship between left ventricular (LV) remodeling and clinical outcomes after treatment of severe mitral regurgitation (MR) in heart failure (HF) has not been examined.<br /><b>Objectives</b><br />The aim of this study was to evaluate the association between LV reverse remodeling and subsequent outcomes and assess whether transcatheter edge-to-edge repair (TEER) and residual MR are associated with LV remodeling in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial.<br /><b>Methods</b><br />Patients with HF and severe MR who remained symptomatic on guideline-directed medical therapy (GDMT) were randomized to TEER plus GDMT or GDMT alone. Baseline and 6-month core laboratory measurements of LV end-diastolic volume index and LV end-systolic volume index were examined. Change in LV volumes from baseline to 6 months and clinical outcomes from 6 months to 2 years were evaluated using multivariable regression.<br /><b>Results</b><br />The analytical cohort comprised 348 patients (190 treated with TEER, 158 treated with GDMT alone). A decrease in LV end-diastolic volume index at 6 months was associated with reduced cardiovascular death between 6 months and 2 years (adjusted HR: 0.90 per 10 mL/m<sup>2</sup> decrease; 95% CI: 0.81-1.00; P = 0.04), with consistent results in both treatment groups (P<sub>interaction</sub> = 0.26). Directionally similar but nonsignificant relationships were present for all-cause death and HF hospitalization and between reduced LV end-systolic volume index and all outcomes. Neither treatment group nor MR severity at 30 days was associated with LV remodeling at 6 or 12 months. The treatment benefits of TEER were not significant regardless of the degree of LV remodeling at 6 months.<br /><b>Conclusions</b><br />In patients with HF and severe MR, LV reverse remodeling at 6 months was associated with subsequently improved 2-year outcomes but was not affected by TEER or the extent of residual MR. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] and COAPT CAS [COAPT]; NCT01626079).<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 22 May 2023; 16:1160-1172</small></div>

<div><h4>Impact of Mitral Regurgitation Etiology on Mitral Surgery After Transcatheter Edge-to-Edge Repair: From the CUTTING-EDGE Registry.</h4><i>Zaid S, Avvedimento M, Vitanova K, Akansel S, ... Tang GHL, CUTTING-EDGE Investigators</i><br /><b>Background</b><br />Although >150,000 mitral TEER procedures have been performed worldwide, the impact of MR etiology on MV surgery after TEER remains unknown.<br /><b>Objectives</b><br />The authors sought to compare outcomes of mitral valve (MV) surgery after failed transcatheter edge-to-edge repair (TEER) stratified by mitral regurgitation (MR) etiology.<br /><b>Methods</b><br />Data from the CUTTING-EDGE registry were retrospectively analyzed. Surgeries were stratified by MR etiology: primary (PMR) and secondary (SMR). MVARC (Mitral Valve Academic Research Consortium) outcomes at 30 days and 1 year were evaluated. Median follow-up was 9.1 months (IQR: 1.1-25.8 months) after surgery.<br /><b>Results</b><br />From July 2009 to July 2020, 330 patients underwent MV surgery after TEER, of which 47% had PMR and 53.0% had SMR. Mean age was 73.8 ± 10.1 years, median STS risk at initial TEER was 4.0% (IQR: 2.2%-7.3%). Compared with PMR, SMR had a higher EuroSCORE, more comorbidities, lower LVEF pre-TEER and presurgery (all P < 0.05). SMR patients had more aborted TEER (25.7% vs 16.3%; P = 0.043), more surgery for mitral stenosis after TEER (19.4% vs 9.0%; P = 0.008), and fewer MV repairs (4.0% vs 11.0%; P = 0.019). Thirty-day mortality was numerically higher in SMR (20.4% vs 12.7%; P = 0.072), with an observed-to-expected ratio of 3.6 (95% CI: 1.9-5.3) overall, 2.6 (95% CI: 1.2-4.0) in PMR, and 4.6 (95% CI: 2.6-6.6) in SMR. SMR had significantly higher 1-year mortality (38.3% vs 23.2%; P = 0.019). On Kaplan-Meier analysis, the actuarial estimates of cumulative survival were significantly lower in SMR at 1 and 3 years.<br /><b>Conclusions</b><br />The risk of MV surgery after TEER is nontrivial, with higher mortality after surgery, especially in SMR patients. These findings provide valuable data for further research to improve these outcomes.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 22 May 2023; 16:1176-1188</small></div>

<div><h4>Impact of High Implantation of Transcatheter Aortic Valve on Subsequent Conduction Disturbances and Coronary Access.</h4><i>Ochiai T, Yamanaka F, Shishido K, Moriyama N, ... Makkar R, Saito S</i><br /><b>Background</b><br />Data regarding the impact of high transcatheter heart valve (THV) implantation on coronary access after transcatheter aortic valve replacement (TAVR) as assessed by postimplantation computed tomography (CT) are scarce.<br /><b>Objectives</b><br />The authors sought to assess the impact of high THV implantation on coronary access after TAVR.<br /><b>Methods</b><br />We included 160 and 258 patients treated with Evolut R/PRO/PRO+ and SAPIEN 3 THVs, respectively. In the Evolut R/PRO/PRO+ group, the target implantation depth was 1 to 3 mm using the cusp overlap view with commissural alignment technique for the high implantation technique (HIT), whereas it was 3 to 5 mm using 3-cusp coplanar view for the conventional implantation technique (CIT). In the SAPIEN 3 group, the HIT employed the radiolucent line-guided implantation, whereas the central balloon marker-guided implantation was used for the CIT. Post-TAVR CT was performed to analyze coronary accessibility.<br /><b>Results</b><br />HIT reduced the incidence of new conduction disturbances after TAVR for both THVs. In the Evolut R/PRO/PRO+ group, post-TAVR CT showed that the HIT group had a higher incidence of the interference of THV skirt (22.0% vs 9.1%; P = 0.03) and a lower incidence of the interference of THV commissural posts (26.0% vs 42.7%; P = 0.04) with access to 1 or both coronary ostia compared with the CIT group. These incidences were similar between the HIT and CIT groups in the SAPIEN 3 group (THV skirt: 0.9% vs 0.7%; P = 1.00; THV commissural tabs: 15.7% vs 15.3%; P = 0.93). In both THVs, CT-identified risk of sinus sequestration in TAVR-in-TAVR was significantly higher in the HIT group compared with the CIT group (Evolut R/PRO/PRO+ group: 64.0% vs 41.8%; P = 0.009; SAPIEN 3 group: 17.6% vs 5.3%; P = 0.002).<br /><b>Conclusions</b><br />High THV implantation substantially reduced conduction disturbances after TAVR. However, post-TAVR CT revealed that there is a risk for unfavorable future coronary access after TAVR and sinus sequestration in TAVR-in-TAVR. (Impact of High Implantation of Transcatheter Heart Valve during Transcatheter Aortic Valve Replacement on Future Coronary Access; UMIN000048336).<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 22 May 2023; 16:1192-1204</small></div>

<div><h4>Coronary Obstruction After Transcatheter Aortic Valve Replacement: Insights From the Spanish TAVI Registry.</h4><i>Ojeda S, González-Manzanares R, Jiménez-Quevedo P, Piñón P, ... Serra V, Pan M</i><br /><b>Background</b><br />Coronary obstruction (CO) following transcatheter aortic valve replacement (TAVR) is a life-threatening complication, scarcely studied.<br /><b>Objectives</b><br />The authors analyzed the incidence of CO after TAVR, presentation, management, and in-hospital and 1-year clinical outcomes in a large series of patients undergoing TAVR.<br /><b>Methods</b><br />Patients from the Spanish TAVI (Transcatheter Aortic Valve Implantation) registry who presented with CO in the procedure, during hospitalization or at follow-up were included. Computed tomography (CT) risk factors were assessed. In-hospital, 30-day, and 1-year all-cause mortality rates were analyzed and compared with patients without CO using logistic regression models in the overall cohort and in a propensity score-matched cohort.<br /><b>Results</b><br />Of 13,675 patients undergoing TAVR, 115 (0.80%) presented with a CO, mainly during the procedure (83.5%). The incidence of CO was stable throughout the study period (2009-2021), with a median annual rate of 0.8% (range 0.3%-1.3%). Preimplantation CT scans were available in 105 patients (91.3%). A combination of at least 2 CT-based risk factors was less frequent in native than in valve-in-valve patients (31.7% vs 78.3%; P < 0.01). Percutaneous coronary intervention was the treatment of choice in 100 patients (86.9%), with a technical success of 78.0%. In-hospital, 30-day, and 1-year mortality rates were higher in CO patients than in those without CO (37.4% vs 4.1%, 38.3% vs 4.3%, and 39.1% vs 9.1%, respectively; P < 0.001).<br /><b>Conclusions</b><br />In this large, nationwide TAVR registry, CO was a rare, but often fatal, complication that did not decrease over time. The lack of identifiable predisposing factors in a subset of patients and the frequently challenging treatment when established may partly explain these findings.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 22 May 2023; 16:1208-1217</small></div>

<div><h4>Myocardial Injury After Transcatheter Aortic Valve Replacement According to VARC-3 Criteria.</h4><i>Real C, Avvedimento M, Nuche J, Franzone A, ... Esposito G, Rodés-Cabau J</i><br /><b>Background</b><br />The Valve Academic Research Consortium (VARC)-3 definition for myocardial injury after transcatheter aortic valve replacement (TAVR) lacks of clinical validation.<br /><b>Objectives</b><br />This study sought to determine the incidence, predictors, and clinical impact of periprocedural myocardial injury (PPMI) following TAVR as defined by recent VARC-3 criteria.<br /><b>Methods</b><br />We included 1,394 consecutive patients who underwent TAVR with a new-generation transcatheter heart valve. High-sensitivity troponin levels were assessed at baseline and within 24 hours after the procedure. PPMI was defined according to VARC-3 criteria as an increase ≥70 times in troponin levels (vs ≥15 times according to the VARC-2 definition). Baseline, procedural, and follow-up data were prospectively collected.<br /><b>Results</b><br />PPMI was diagnosed in 193 (14.0%) patients. Female sex and peripheral artery disease were independent predictors of PPMI (P < 0.01 for both). PPMI was associated with a higher risk of mortality at 30-day (HR: 2.69, 95% CI: 1.50-4.82; P = 0.001) and 1-year (for all-cause mortality, HR: 1.54; 95% CI: 1.04-2.27; P = 0.032; for cardiovascular mortality, HR: 3.04; 95% CI: 1.68-5.50; P < 0.001) follow-up. PPMI according to VARC-2 criteria had no impact on mortality.<br /><b>Conclusions</b><br />About 1 out of 10 patients undergoing TAVR in the contemporary era had PPMI as defined by recent VARC-3 criteria, and baseline factors like female sex and peripheral artery disease determined an increased risk. PPMI had a negative impact on early and late survival. Further studies on the prevention of PPMI post-TAVR and implementing measures to improve outcomes in PPMI patients are warranted.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 22 May 2023; 16:1221-1232</small></div>

<div><h4>Transcatheter Treatment of Native Aortic Valve Regurgitation: The North American Experience with a Novel Device.</h4><i>Garcia S, Ye J, Webb J, Reardon M, ... Jollis JG, Kereiakes DJ</i><br /><b>Background</b><br />Transcatheter treatment of native aortic valve regurgitation (AR) has been limited by anatomic factors. No transcatheter device has received U.S. regulatory approval for the treatment of AR.<br /><b>Objectives</b><br />To describe the compassionate use experience in North America with a dedicated transcatheter device (J-Valve, J.C. Medical, Burlingame, CA).<br /><b>Methods</b><br />Multicenter, observational registry of compassionate use cases of J-Valve for the treatment of patients with severe symptomatic aortic regurgitation and elevated surgical risk in North America. The J-Valve consists of a self-expanding nitinol frame, bovine pericardial leaflets, and a valve locating feature. The available size matrix (5 sizes) can treat a wide range of anatomies (minimum/maximal annular perimeters 57-109 mm).<br /><b>Results</b><br />A total of 27 patients (median age 81 [72-85], 81% high surgical risk, 96% NYHA FC III-IV) with native valve AR were treated with J-Valve during the study period (2018-2022). Procedural success (J-Valve delivered to the intended location without need for surgical conversion or a second THV) was 81% (22 out 27 cases) in the overall experience and 100% in the last 15 cases. Two cases required conversion to surgery in the early experience leading to changes in valve design. At 30-days, there were 1 death, 1 stroke, 3 new pacemakers (13%), and 88% of patients were NYHA FC I-II. No patient had residual AR ≥ moderate at 30-days.<br /><b>Conclusion</b><br />J-Valve appears to provide a safe and effective alternative to surgery in patients with pure aortic regurgitation and elevated/prohibitive surgical risk.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>JACC Cardiovasc Interv: 12 May 2023; epub ahead of print</small></div>

<div><h4>Anonymous Comparison of Various Angiography-Derived Fractional Flow Reserve Software With Pressure-Derived Physiological Assessment.</h4><i>Ninomiya K, Serruys PW, Kotoku N, Zhou J, ... Patel MR, Onuma Y</i><br /><b>Background</b><br />Software to compute angiography-derived fractional flow reserve (angio-FFR) have been validated against pressure wire-derived fractional flow reserve (PW-FFR) with an area under the receiver-operating characteristic curve (AUC) of 0.93 to 0.97.<br /><b>Objectives</b><br />The aim of this study was to investigate diagnostic accuracies of 5 angio-FFR software/methods by an independent core lab in a prospective cohort of 390 vessels with carefully documented sites of PW-FFR and pressure wire-derived instantaneous wave-free ratio.<br /><b>Methods</b><br />One \"matcher investigator\" colocalized on angiography the sites of pressure wire measurement with angio-FFR measurements and provided the same 2 optimal angiographic views and frame selection to independent analysts who were blinded to invasive physiological results and results from other software. The results were anonymized and randomly presented. The AUC of each angio-FFR was compared with 2-dimensional quantitative coronary angiography (QCA) percent diameter stenosis (%DS) using a 2-tailed paired comparison of AUC.<br /><b>Results</b><br />All 5 software/methods yielded a high proportion of analyzable vessels (A: 100%, B: 100%, C: 92.1%, D: 99.5%, and E: 92.1%). The AUCs for predicting fractional flow reserve ≤0.8 for software A, B, C, D, E, and 2-dimensional QCA %DS were 0.75, 0.74, 0.74, 0.73, 0.73, and 0.65, respectively. The AUC for each angio-FFR was significantly greater than that for 2-dimensional QCA %DS.<br /><b>Conclusions</b><br />This head-to-head comparison by an independent core lab demonstrated that the diagnostic accuracy of various angio-FFR software for predicting PW-FFR ≤0.80 was useful, with a higher discrimination compared with 2-dimensional QCA %DS; however, it did not reach the diagnostic accuracy previously reported in validation studies of various vendors. Therefore, the intrinsic clinical value of \"angiography-derived fractional flow reserve\" requires confirmation in large clinical trials.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 10 May 2023; epub ahead of print</small></div>

<div><h4>Validation of UK-BCIS CHIP Score to Predict 1-Year Outcomes in a Contemporary United States Population.</h4><i>Khandelwal G, Spirito A, Tanner R, Koshy AN, ... Kini AS, Sharma SK</i><br /><b>Background</b><br />A complex high-risk indicated percutaneous coronary intervention (CHIP) score was recently developed from the British Cardiovascular Intervention Society (BCIS) database to define CHIP cases and their risk of in-hospital major adverse cardiac or cerebrovascular events (MACCE).<br /><b>Objectives</b><br />The authors sought to apply this score to a contemporary U.S. population for the prediction of adverse events at 1 year following percutaneous coronary intervention (PCI).<br /><b>Methods</b><br />Consecutive patients undergoing PCI at a large tertiary care center between 2011 and 2020 were considered for inclusion. Patients were categorized into 4 groups based on their BCIS-CHIP score (0, 1-2, 3-4, ≥5). In each category, we assessed the 1-year risk of MACCE, a composite of all-cause death, myocardial infarction, and stroke. Secondary outcomes were the individual components of MACCE, and major bleeding at 1 year.<br /><b>Results</b><br />Among 20,799 patients included, MACCE at 1 year occurred in 1.7% patients with score 0 (reference), 3.0% with score 1 or 2 (HR: 1.72; 95% CI: 1.32-2.24), 6.1% with score 3 or 4 (HR: 3.60; 95% CI: 2.78-4.66), and 12.0% with score ≥5 (HR: 7.40; 95% CI: 5.75-9.51). Each point increase of the BCIS-CHIP score conferred a 28.0% increase of MACCE risk. The BCIS-CHIP score demonstrated good discrimination for the prediction of 1-year MACCE (C-index 0.70). The risk of secondary outcomes also progressively increased with higher score values.<br /><b>Conclusions</b><br />In a large PCI registry, the BCIS-CHIP score had a good predictive value for MACCE at 1 year. The utilization of this score can facilitate an accurate risk stratification of patients undergoing PCI.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 08 May 2023; 16:1011-1020</small></div>

<div><h4>Impact of Eruptive vs Noneruptive Calcified Nodule Morphology on Acute and Long-Term Outcomes After Stenting.</h4><i>Sato T, Matsumura M, Yamamoto K, Shlofmitz E, ... Ali ZA, Maehara A</i><br /><b>Background</b><br />Whether an eruptive or noneruptive target lesion calcified nodule (CN) portends worse acute and long-term clinical outcomes after stenting has not been established.<br /><b>Objectives</b><br />The authors sought to compare acute and long-term clinical outcomes in eruptive CN vs noneruptive CN morphology.<br /><b>Methods</b><br />Using optical coherence tomography, an eruptive CN was defined as an accumulation of small calcium fragments protruding and disrupting the overlying fibrous cap, typically with small amount of thrombus. A noneruptive CN was defined as an accumulation of small calcium fragments with a smooth intact fibrous cap without an overlying thrombus. The primary endpoint was target lesion failure (TLF) including cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization in patients with ≥6-month follow-up.<br /><b>Results</b><br />Among 3,231 patients with evaluable pre- and postintervention OCT, 236 patients had lesions with CNs (7.3%). After eliminating 4 secondary lesions and 6 patients without ≥6-month follow-up, 126 (54.8%) lesions with eruptive CNs and 104 (45.2%) lesions with noneruptive CNs formed the current report. Compared with noneruptive CNs, eruptive CNs were independently associated with greater stent expansion (89.2% ± 18.7% vs. 81.5% ± 18.9%; P = 0.003) after adjusting for morphologic and procedural factors. At 2 years, eruptive CNs trended toward more TLF compared with noneruptive CNs (Kaplan-Meier estimates, 19.8% vs 12.5%; P = 0.11) and significantly more target lesion revascularization (18.3% vs 9.6%; P = 0.04). In the adjusted model, eruptive CNs were independently associated with 2-year TLF (HR: 2.07; 95% CI: 1.01-4.50; P = 0.048).<br /><b>Conclusions</b><br />Compared with noneruptive CN morphology, lesions with an eruptive CN appearance on optical coherence tomography had a worse poststent long-term clinical outcome despite better acute stent expansion.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>JACC Cardiovasc Interv: 08 May 2023; 16:1024-1035</small></div>

<div><h4>The Association Between Angiographically Derived Radial Wall Strain and the Risk of Acute Myocardial Infarction.</h4><i>Li C, Wang Z, Yang H, Hong H, ... Tu S, Ge J</i><br /><b>Background</b><br />The radial wall strain (RWS) is a novel angiography-based method to assess the biomechanical property of the coronary artery and whether it can predict future acute myocardial infarction (AMI) events remains to be elucidated.<br /><b>Objectives</b><br />This study aimed to investigate the association between angiography-derived RWS and future AMI events in mild to intermediate lesions.<br /><b>Methods</b><br />We performed a matched case-control analysis nested in a retrospective cohort of patients who had received prior angiography (the index procedure) at least 1 month before and were hospitalized again for repeat angiography. Patients with at least 1 de novo mild to intermediate lesion identified at the index procedure and eligible for RWS analysis were enrolled. The study identified cases with target lesion-related AMI diagnosed at the repeat angiography, matching each case to 3 control subjects without AMI.<br /><b>Results</b><br />Altogether 44 patients with lesion-related AMI and 132 matched controls were enrolled. The median diameter stenosis of the overall interrogated lesions was 34.0%. The baseline maximum RWS (RWS<sub>max</sub>), which was defined as the highest RWS in the stenotic segment, was significantly higher in lesions responsible for AMI than those that remained quiescent (median 13% vs 10%; P < 0.001). RWS<sub>max</sub> was predictive of lesion-related AMI, with an area under the curve of 0.83 (95% CI: 0.76-0.90; P < 0.001) and an optimal cutoff >12%. RWS<sub>max</sub> >12% was found to be independently associated with subsequent AMI events with a risk ratio of 7.25 (95% CI: 3.94-13.37; P < 0.001).<br /><b>Conclusions</b><br />Among angiographically mild to intermediate lesions, a high-strain pattern identified by angiography-derived RWS was associated with an increased risk of AMI events.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 08 May 2023; 16:1039-1049</small></div>

<div><h4>Long-Term Outcome of Drug-Coated Balloon vs Drug-Eluting Stent for Small Coronary Vessels: PICCOLETO-II 3-Year Follow-Up.</h4><i>Cortese B, Testa G, Rivero F, Erriquez A, Alfonso F</i><br /><b>Background</b><br />Native vessel coronary artery disease represents 1 of the most attractive fields of application for drug-coated balloons (DCBs). To date, several devices have been compared with drug-eluting stents (DESs) in this setting with different outcomes.<br /><b>Objectives</b><br />The authors sought to compare the short- and long-term performance of the paclitaxel DCB with the everolimus-eluting stent in patients with de novo lesions in small coronary vessel disease.<br /><b>Methods</b><br />PICCOLETO II (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment) was an academic, international, investigator-driven, multicenter, open-label randomized clinical trial in which patients were allocated to a DCB (n = 118) or DES (n = 114). We previously reported the superiority of DCBs regarding in-lesion late lumen loss at 6 months. Herein we report the final 3-year clinical follow-up with the occurrence of major adverse cardiac events (MACEs), a composite of cardiac death, nonfatal myocardial infarction, target lesion revascularization, and its individual components.<br /><b>Results</b><br />The 3-year clinical follow-up (median 1,101 days; IQR: 1,055-1,146 days) was available for 102 patients allocated to DCB and 101 to DES treatment. The cumulative rate of all-cause death (4% vs 3.9%; P = 0.98), cardiac death (1% vs 1.9%; P = 0.56), myocardial infarction (6.9% vs 2%; P = 0.14), and target lesion revascularization (14.8% vs 8.8%; P = 0.18) did not significantly differ between DCBs and DESs. MACEs and acute vessel occlusion occurred more frequently in the DES group (20.8% vs 10.8% [P = 0.046] and 4% vs 0% [P = 0.042], respectively).<br /><b>Conclusions</b><br />The long-term clinical follow-up of the PICCOLETO II randomized clinical trial shows a higher risk of MACEs in patients with de novo lesions in small vessel disease when they are treated with the current-generation DES compared with the new-generation paclitaxel DCB. (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment [PICCOLETO II]; NCT03899818).<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 08 May 2023; 16:1054-1061</small></div>

<div><h4>5-Year Outcomes of Drug-Coated Balloons for Peripheral Artery In-Stent Restenosis, Long Lesions, and CTOs.</h4><i>Tepe G, Brodmann M, Micari A, Scheinert D, ... Zeller T, IN.PACT Global Study Investigators</i><br /><b>Background</b><br />Long-term data on drug-coated balloon (DCB) outcomes in complex femoropopliteal atherosclerotic lesions are limited.<br /><b>Objectives</b><br />The authors sought to report 5-year safety and effectiveness outcomes of a paclitaxel DCB for the treatment of de novo in-stent restenosis (ISR), long lesions (LL), or chronic total occlusions (CTOs) in the prespecified imaging cohorts of the IN.PACT Global Study.<br /><b>Methods</b><br />The IN.PACT Global study was a prospective, international single-arm study. Assessments through 5 years included freedom from clinically driven target lesion revascularization (CD-TLR), a safety composite (freedom from device- and procedure-related death to 30 days, and freedom from major target limb amputation and freedom from clinically driven target vessel revascularization within 60 months), and major adverse events.<br /><b>Results</b><br />The prespecified imaging cohorts enrolled 132 de novo ISR, 158 LL, and 127 CTO participants. Kaplan-Meier estimates of freedom from CD-TLR through 5 years were 58.0% (ISR), 67.3% (LL), and 69.8% (CTO). The cumulative incidences of the composite safety endpoint were 56.0% (ISR), 65.7% (LL), and 69.8% (CTO). The 5-year freedom from all-cause mortality with vital status update were 81.4% (ISR), 75.2% (LL), and 78.2% (CTO). Within the ISR cohort, 15.9% of participants experienced 2 or more TLRs, compared with 9.5% and 5.5% in the LL and CTO groups, respectively.<br /><b>Conclusions</b><br />Results demonstrate long-term safety and effectiveness of this DCB in all 3 cohorts, with low reintervention rates in the LL and CTO cohorts and no safety issues. These results support the inclusion of this DCB into the treatment algorithm for complex femoropopliteal disease.<br /><br />Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 08 May 2023; 16:1065-1078</small></div>

<div><h4>Impact of Right Ventricular Pacing in Patients With TAVR Undergoing Permanent Pacemaker Implantation.</h4><i>Bruno F, Munoz Pousa I, Saia F, Vaira MP, ... D\'Ascenzo F, De Ferrari GM</i><br /><b>Background</b><br />Long-term right ventricular pacing (VP) has been related to negative left ventricular remodeling and heart failure (HF), but there is a lack of evidence regarding the prognostic impact on transcatheter aortic valve replacement (TAVR) patients.<br /><b>Objectives</b><br />The aim of the PACE-TAVI registry is to evaluate the association of high percentage of VP with adverse outcomes in patients with pacemaker implantation after TAVR.<br /><b>Methods</b><br />PACE-TAVI is an international multicenter registry of all consecutive TAVR patients who underwent permanent pacemaker implantation for conduction disturbances in the first 30 days after the procedure. Patients were divided into 2 subgroups according to the percentage of VP (<40% vs ≥40%) at pacemaker interrogation. The primary endpoint was the composite of cardiovascular mortality or hospitalization for HF.<br /><b>Results</b><br />A total of 377 patients were enrolled, 158 with VP <40% and 219 with VP ≥40%. After multivariable adjustment, VP ≥40% was associated with a higher incidence of the primary endpoint (HR: 2.76; 95% CI: 1.39-5.51; P = 0.004), first HF hospitalization (HR: 3.37; 95% CI: 1.50-7.54; P = 0.003), and cardiovascular death (HR: 3.77; 95% CI: 1.02-13.88; P = 0.04), while the incidence of all-cause death was not significantly different (HR: 2.17; 95% CI: 0.80-5.90; P = 0.13). Patients with VP ≥ 40% showed a higher New York Heart Association functional class both at 1 year (P = 0.009) and at last available follow-up (P = 0.04) and a nonsignificant reduction of left ventricular ejection fraction (P = 0.18) on 1-year echocardiography, while patients with VP <40% showed significant improvement (P = 0.009).<br /><b>Conclusions</b><br />In TAVR patients undergoing permanent pacemaker implantation, a high percentage of right VP at follow-up is associated with an increased risk for cardiovascular death and HF hospitalization. These findings suggest the opportunity to minimize right VP through dedicated algorithms in post-TAVR patients without complete atrioventricular block and to evaluate a more physiological VP modality in patients with persistent complete atrioventricular block.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 08 May 2023; 16:1081-1091</small></div>

<div><h4>Sex Differences in Outcomes After Transcatheter Aortic Valve Replacement: A POPular TAVI Subanalysis.</h4><i>van Bergeijk KH, van Ginkel DJ, Brouwer J, Nijenhuis VJ, ... Wykrzykowska JJ, Ten Berg JM</i><br /><b>Background</b><br />Stroke and bleeding are complications after transcatheter aortic valve replacement (TAVR). A higher incidence of bleeding and stroke has been reported in women, but the role of antithrombotic management pre- and post-TAVR has not been studied.<br /><b>Objectives</b><br />The study sought to compare bleeding and ischemic complications after TAVR between women and men stratified by antiplatelet and oral anticoagulant (OAC) regimen.<br /><b>Methods</b><br />The POPular TAVI (Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation) trial was a randomized clinical trial to test the hypothesis that monotherapy with aspirin or OAC after TAVR is safer than the addition of clopidogrel. The primary endpoints of interest of this post hoc subanalysis were: 1) all bleeding; and 2) a composite of ischemic events consisting of stroke and myocardial infarction. Secondary endpoints were: 1) nonprocedural bleeding; 2) major or life-threatening bleeding; 3) minor bleeding; 4) stroke; 5) myocardial infarction; and 6) all-cause death.<br /><b>Results</b><br />A total of 978 patients (466 [47.6%] women) were included in this study. All bleeding and the composite of myocardial infarction and stroke rates were similar between sexes (all bleeding: 106 [22.8%] women vs 121 [23.6%] men; P = 0.815; ischemic events: 26 [5.6%] vs 36 [7.0%]; P = 0.429). However, major or life-threatening bleeding occurred more often in women (58 [12.5%]) vs men (38 [7.4%]) (P = 0.011), most of which were access site bleedings. The use of aspirin pre- and post-TAVR increased major or life-threatening bleeding in women but not in men.<br /><b>Conclusions</b><br />After TAVR, overall bleeding and ischemic outcomes were similar between women and men. However, women had more major or life-threatening bleedings, especially those receiving aspirin pre- and post-TAVR.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 08 May 2023; 16:1095-1102</small></div>

<div><h4>Emerging Approaches to Management of Left Ventricular Outflow Obstruction Risk in Transcatheter Mitral Valve Replacement.</h4><i>Eleid MF, Collins JD, Mahoney P, Williamson EE, ... Rihal CS, Guerrero ME</i><br /><AbstractText>An increasing number of patients with mitral valve disease are high risk for surgery and in need of less invasive treatments including transcatheter mitral valve replacement (TMVR). Left ventricular outflow tract (LVOT) obstruction is a predictor of poor outcome after TMVR, and its risk can be accurately predicted using cardiac computed tomography analysis. Novel treatment strategies that have shown efficacy in reducing risk of LVOT obstruction after TMVR include pre-emptive alcohol septal ablation, radiofrequency ablation, and anterior leaflet electrosurgical laceration. This review describes recent advances in the management of LVOT obstruction risk after TMVR, provides a new management algorithm, and explores forthcoming studies that will further advance the field.</AbstractText><br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 24 Apr 2023; 16:885-895</small></div>

<div><h4>Impact of Transcatheter Edge-to-Edge Mitral Valve Repair on Guideline-Directed Medical Therapy Uptitration.</h4><i>Adamo M, Tomasoni D, Stolz L, Stocker TJ, ... Hausleiter J, Metra M</i><br /><b>Background</b><br />Guideline-directed medical therapy (GDMT) optimization is mandatory before transcatheter edge-to-edge mitral valve repair (M-TEER) in patients with secondary mitral regurgitation (SMR) and heart failure (HF) with reduced ejection fraction (HFrEF). However, the effect of M-TEER on GDMT is unknown.<br /><b>Objectives</b><br />The authors sought to evaluate frequency, prognostic implications and predictors of GDMT uptitration after M-TEER in patients with SMR and HFrEF.<br /><b>Methods</b><br />This is a retrospective analysis of prospectively collected data from the EuroSMR Registry. The primary events were all-cause death and the composite of all-cause death or HF hospitalization.<br /><b>Results</b><br />Among the 1,641 EuroSMR patients, 810 had full datasets regarding GDMT and were included in this study. GDMT uptitration occurred in 307 patients (38%) after M-TEER. Proportion of patients receiving angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors, beta-blockers, and mineralocorticoid receptor antagonists was 78%, 89%, and 62% before M-TEER and 84%, 91%, and 66% 6 months after M-TEER (all P < 0.001). Patients with GDMT uptitration had a lower risk of all-cause death (adjusted HR: 0.62; 95% CI: 0.41-0.93; P = 0.020) and of all-cause death or HF hospitalization (adjusted HR: 0.54; 95% CI: 0.38-0.76; P < 0.001) compared with those without. Degree of MR reduction between baseline and 6-month follow-up was an independent predictor of GDMT uptitration after M-TEER (adjusted OR: 1.71; 95% CI: 1.08-2.71; P = 0.022).<br /><b>Conclusions</b><br />GDMT uptitration after M-TEER occurred in a considerable proportion of patients with SMR and HFrEF and is independently associated with lower rates for mortality and HF hospitalizations. A greater decrease in MR was associated with increased likelihood for GDMT uptitration.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 24 Apr 2023; 16:896-905</small></div>

<div><h4>Sex-Related Differences in Clinical Characteristics and Outcome Prediction Among Patients Undergoing Transcatheter Tricuspid Valve Intervention.</h4><i>Fortmeier V, Lachmann M, Körber MI, Unterhuber M, ... Lurz P, Rudolph V</i><br /><b>Background</b><br />Men and women differ regarding comorbidities, pathophysiology, and the progression of valvular heart diseases.<br /><b>Objectives</b><br />This study sought to assess sex-related differences regarding clinical characteristics and the outcome of patients with severe tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve intervention (TTVI).<br /><b>Methods</b><br />All 702 patients in this multicenter study underwent TTVI for severe TR. The primary outcome was 2-year all-cause mortality.<br /><b>Results</b><br />Among 386 women and 316 men in this study, men were more often diagnosed with coronary artery disease (52.9% in men vs 35.5% in women; P = 5.6 × 10<sup>-6</sup>). Subsequently, the underlying etiology for TR in men was predominantly secondary ventricular (64.6% in men vs 50.0% in women; P = 1.4 × 10<sup>-4</sup>), whereas women more often presented with secondary atrial etiology (41.7% in women vs 24.4% in men, P = 2.0 × 10<sup>-6</sup>). Notably, 2-year survival after TTVI was similar in women and men (69.9% in women vs 63.7% in men; P = 0.144). Multivariate regression analysis identified dyspnea expressed as New York Heart Association functional class, tricuspid annulus plane systolic excursion (TAPSE), and mean pulmonary artery pressure (mPAP) as independent predictors for 2-year mortality. The prognostic significance of TAPSE and mPAP differed between sexes. Consequently, we looked at right ventricular-pulmonary arterial coupling expressed as TAPSE/mPAP and identified sex-specific thresholds to best predict survival; women with a TAPSE/mPAP ratio <0.612 mm/mm Hg displayed a 3.43-fold increased HR for 2-year mortality (P < 0.001), whereas men with a TAPSE/mPAP ratio <0.434 mm/mm Hg displayed a 2.05-fold increased HR for 2-year mortality (P = 0.001).<br /><b>Conclusions</b><br />Even though men and women differ in the etiology of TR, both sexes show similar survival rates after TTVI. The TAPSE/mPAP ratio can improve prognostication after TTVI, and sex-specific thresholds should be applied to guide future patient selection.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 24 Apr 2023; 16:909-923</small></div>

<div><h4>Explant vs Redo-TAVR After Transcatheter Valve Failure: Mid-Term Outcomes From the EXPLANTORREDO-TAVR International Registry.</h4><i>Tang GHL, Zaid S, Kleiman NS, Goel SS, ... Reardon MJ, Sathananthan J</i><br /><b>Background</b><br />Valve reintervention after transcatheter aortic valve replacement (TAVR) failure has not been studied in detail.<br /><b>Objectives</b><br />The authors sought to determine outcomes of TAVR surgical explantation (TAVR-explant) vs redo-TAVR because they are largely unknown.<br /><b>Methods</b><br />From May 2009 to February 2022, 396 patients in the international EXPLANTORREDO-TAVR registry underwent TAVR-explant (181, 46.4%) or redo-TAVR (215, 54.3%) for transcatheter heart valve (THV) failure during a separate admission from the initial TAVR. Outcomes were reported at 30 days and 1 year.<br /><b>Results</b><br />The incidence of reintervention after THV failure was 0.59% with increasing volume during the study period. Median time from index-TAVR to reintervention was shorter in TAVR-explant vs redo-TAVR (17.6 months [IQR: 5.0-40.7 months] vs 45.7 months [IQR: 10.6-75.6 months]; P < 0.001], respectively. TAVR-explant had more prosthesis-patient mismatch (17.1% vs 0.5%; P < 0.001) as the indication for reintervention, whereas redo-TAVR had more structural valve degeneration (63.7% vs 51.9%; P = 0.023), with a similar incidence of ≥moderate paravalvular leak between groups (28.7% vs 32.8% in redo-TAVR; P = 0.44). There was a similar proportion of balloon-expandable THV failures (39.8% TAVR-explant vs 40.5% redo-TAVR; P = 0.92). Median follow-up was 11.3 (IQR: 1.6-27.1 months) after reintervention. Compared with redo-TAVR, TAVR-explant had higher mortality at 30 days (13.6% vs 3.4%; P < 0.001) and 1 year (32.4% vs 15.4%; P = 0.001), with similar stroke rates between groups. On landmark analysis, mortality was similar between groups after 30 days (P = 0.91).<br /><b>Conclusions</b><br />In this first report of the EXPLANTORREDO-TAVR global registry, TAVR-explant had a shorter median time to reintervention, with less structural valve degeneration, more prosthesis-patient mismatch, and similar paravalvular leak rates compared with redo-TAVR. TAVR-explant had higher mortality at 30 days and 1 year, but similar rates on landmark analysis after 30 days.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 24 Apr 2023; 16:927-941</small></div>

<div><h4>Redo Surgical Aortic Valve Replacement After Prior Transcatheter Versus Surgical Aortic Valve Replacement.</h4><i>Hawkins RB, Deeb GM, Sukul D, Patel HJ, ... Ailawadi G, Fukuhara S</i><br /><b>Background</b><br />Aortic stenosis treatment should consider risks and benefits for lifetime management. Although the feasibility of redo transcatheter aortic valve replacement (TAVR) remains unclear, concerns are emerging regarding reoperation after TAVR.<br /><b>Objectives</b><br />The authors sought to define comparative risk of surgical aortic valve replacement (SAVR) after prior TAVR or SAVR.<br /><b>Methods</b><br />Data on patients undergoing bioprosthetic SAVR after TAVR and/or SAVR were extracted from the Society of Thoracic Surgeons Database (2011-2021). Overall and isolated SAVR cohorts were analyzed. The primary outcome was operative mortality. Risk adjustment using hierarchical logistic regression as well as propensity score matching for isolated SAVR cases were performed.<br /><b>Results</b><br />Of 31,106 SAVR patients, 1,126 had prior TAVR (TAVR-SAVR), 674 had prior SAVR and TAVR (SAVR-TAVR-SAVR), and 29,306 had prior SAVR (SAVR-SAVR). Yearly rates of TAVR-SAVR and SAVR-TAVR-SAVR increased over time, whereas SAVR-SAVR was stable. The TAVR-SAVR patients were older, with higher acuity, and with greater comorbidities than other cohorts. The unadjusted operative mortality was highest in the TAVR-SAVR group (17% vs 12% vs 9%, respectively; P < 0.001). Compared with SAVR-SAVR, risk-adjusted operative mortality was significantly higher for TAVR-SAVR (OR: 1.53; P = 0.004), but not SAVR-TAVR-SAVR (OR: 1.02; P = 0.927). After propensity score matching, operative mortality of isolated SAVR was 1.74 times higher for TAVR-SAVR than SAVR-SAVR patients (P = 0.020).<br /><b>Conclusions</b><br />The number of post-TAVR reoperations is increasing and represent a high-risk population. Yet even in isolated SAVR cases, SAVR after TAVR is independently associated with increased risk of mortality. Patients with life expectancy beyond a TAVR valve and unsuitable anatomy for redo-TAVR should consider a SAVR-first approach.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 24 Apr 2023; 16:942-953</small></div>

<div><h4>Prevalence and Predictors of Cardiogenic Shock in Intermediate-Risk Pulmonary Embolism: Insights From the FLASH Registry.</h4><i>Bangalore S, Horowitz JM, Beam D, Jaber WA, ... Weinberg MD, Mina B</i><br /><b>Background</b><br />Patients with acute pulmonary embolism (PE) and hypotension (high-risk PE) have high mortality. Cardiogenic shock can also occur in nonhypotensive or normotensive patients (intermediate-risk PE) but is less well characterized.<br /><b>Objectives</b><br />The authors sought to evaluate the prevalence and predictors of normotensive shock in intermediate-risk PE.<br /><b>Methods</b><br />Intermediate-risk PE patients in the FLASH (FlowTriever All-Comer Registry for Patient Safety and Hemodynamics) registry undergoing mechanical thrombectomy with the FlowTriever System (Inari Medical) were included. The prevalence of normotensive shock (systolic blood pressure ≥90 mm Hg but cardiac index ≤2.2 L/min/m<sup>2</sup>) was assessed. A composite shock score consisting of markers of right ventricular function and ischemia (elevated troponin, elevated B-type natriuretic peptide, moderately/severely reduced right ventricular function), central thrombus burden (saddle PE), potential additional embolization (concomitant deep vein thrombosis), and cardiovascular compensation (tachycardia) was prespecified and assessed for its ability to identify normotensive shock patients.<br /><b>Results</b><br />Over one-third of intermediate-risk PE patients in FLASH (131/384, 34.1%) were in normotensive shock. The normotensive shock prevalence was 0% in patients with a composite shock score of 0 and 58.3% in those with a score of 6 (highest score). A score of 6 was a significant predictor of normotensive shock (odds ratio: 5.84; 95% CI: 2.00-17.04). Patients showed significant on-table improvements in hemodynamics post-thrombectomy, including normalization of the cardiac index in 30.5% of normotensive shock patients. Right ventricular size, function, dyspnea, and quality of life significantly improved at the 30-day follow-up.<br /><b>Conclusions</b><br />Although hemodynamically stable, over one-third of intermediate-risk FLASH patients were in normotensive shock with a depressed cardiac index. A composite shock score effectively further risk stratified these patients. Mechanical thrombectomy improved hemodynamics and functional outcomes at the 30-day follow-up.<br /><br />Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 24 Apr 2023; 16:958-972</small></div>

<div><h4>Periprocedural Complications With Balloon Pulmonary Angioplasty: Analysis of Global Studies.</h4><i>Jain N, Sheikh MA, Bajaj D, Townsend W, ... Mclaughlin VV, Aggarwal V</i><br /><b>Background</b><br />Balloon pulmonary angioplasty (BPA) was introduced as a treatment modality for patients with inoperable, medically refractory chronic thromboembolic pulmonary hypertension decades ago; however, reports of high rates of pulmonary vascular injury have led to considerable refinement in procedural technique.<br /><b>Objectives</b><br />The authors sought to better understand the evolution of BPA procedure-related complications over time.<br /><b>Methods</b><br />The authors conducted a systematic review of original articles published by pulmonary hypertension centers globally and performed a pooled cohort analysis of procedure-related outcomes with BPA.<br /><b>Results</b><br />This systematic review identified 26 published articles from 18 countries worldwide from 2013 to 2022. A total of 1,714 patients underwent 7,561 total BPA procedures with an average follow up of 7.3 months. From the first period (2013-2017) to the second period (2018-2022), the cumulative incidence of hemoptysis/vascular injury decreased from 14.1% (474/3,351) to 7.7% (233/3,029) (P < 0.01); lung injury/reperfusion edema decreased from 11.3% (377/3,351) to 1.4% (57/3,943) (P < 0.01); invasive mechanical ventilation decreased from 0.7% (23/3,195) to 0.1% (4/3,062) (P < 0.01); and mortality decreased from 2.0% (13/636) to 0.8% (8/1,071) (P < 0.01).<br /><b>Conclusions</b><br />Procedure-related complications with BPA, including hemoptysis/vascular injury, lung injury/reperfusion edema, mechanical ventilation, and death, were less common in the second period (2018-2022), compared with first period (2013-2017), likely from refinement in patient and lesion selection and procedural technique over time.<br /><br />Published by Elsevier Inc.<br /><br /><small>JACC Cardiovasc Interv: 24 Apr 2023; 16:976-983</small></div>

<div><h4>Clinical Impact of CYP2C19 Genotype on Clopidogrel-Based Antiplatelet Therapy After Percutaneous Coronary Intervention.</h4><i>Lee SH, Jeong YH, Hong D, Choi KH, ... Song YB, PTRG-DES Registry Investigators</i><br /><b>Background</b><br />Although there is a growing body of evidence that CYP2C19 genotyping can be beneficial when considering treatment with clopidogrel after percutaneous coronary intervention (PCI), whether a genotype-guided strategy can be generally adopted in routine practice remains unclear among East Asians.<br /><b>Objectives</b><br />This study sought to investigate long-term outcomes of patients undergoing clopidogrel-based antiplatelet therapy after drug-eluting stent (DES) implantation according to CYP2C19 genotypes.<br /><b>Methods</b><br />From the nationwide multicenter PTRG-DES (Platelet function and genoType-Related long-term proGnosis in DES-treated patients) consortium, patients who underwent CYP2C19 genotyping were selected and classified according to CYP2C19 loss-of-function allele: rapid metabolizers (RMs) or normal metabolizers (NMs) vs intermediate metabolizers (IMs) or poor metabolizers (PMs). The primary outcome was a composite of cardiac death, myocardial infarction, and stent thrombosis at 5 years after the index procedure.<br /><b>Results</b><br />Of 8,163 patients with CYP2C19 genotyping, 56.7% presented with acute coronary syndrome. There were 3,098 (37.9%) in the RM or NM group, 3,906 (47.9%) in the IM group, and 1,159 (14.2%) in the PM group. IMs or PMs were associated with an increased risk of 5-year primary outcome compared with RMs or NMs (HR<sub>adj</sub>: 1.42; 95% CI: 1.01-1.98; P = 0.041), and the effect was more pronounced in the first year (HR<sub>adj</sub>: 1.67; 95% CI: 1.10-2.55; P = 0.016). The prognostic implication of being an IM and PM was significant in acute coronary syndrome patients (HR<sub>adj</sub>: 1.88; 95% CI: 1.20-2.93; P = 0.005) but not in those with stable angina (HR<sub>adj</sub>: 0.92; 95% CI: 0.54-1.55; P = 0.751) (interaction P = 0.028).<br /><b>Conclusions</b><br />Among East Asians with clopidogrel-based antiplatelet therapy after DES implantation, CYP2C19 genotyping could stratify patients who were likely to have an increased risk of atherothrombotic events. (Platelet Function and genoType-Related Long-term progGosis in DES-treated Patients: A Consortium From Multi-centered Registries [PTRG-DES]; NCT04734028).<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 10 Apr 2023; 16:829-843</small></div>

<div><h4>Provisional Strategy for Left Main Stem Bifurcation Disease: A State-of-the-Art Review of Technique and Outcomes.</h4><i>Paradies V, Banning A, Cao D, Chieffo A, ... Smits PC, Van Mieghem NM</i><br /><AbstractText>Left main coronary artery (LMA) disease jeopardizes a large area of myocardium and increases the risk of major adverse cardiovascular events. LMCA disease is found in 5% to 7% of all diagnostic coronary angiographies, and more than 80% of the patients enrolled in recent large randomized controlled left main trials had distal left main bifurcation or trifurcation disease. Emerging clinical evidence from prospective all-comer registries and randomized trials has provided a solid basis for percutaneous coronary intervention as a treatment option in selected patients with unprotected LMCA disease; however, to date, no uniform recommendations as to optimal stenting strategy for LMCA bifurcation lesions exist. This review provides an overview of provisional stenting technique and escalation to 2-stent strategies in LMCA bifurcation lesions. Data from randomized controlled trials and registries are reviewed. Technical characteristics of optimal provisional LMCA stenting technique and angiographic and intravascular determinants of escalation are also summarized.</AbstractText><br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 10 Apr 2023; 16:743-758</small></div>

<div><h4>A Randomized Comparison of 2 Different Drug-Coated Balloons for In-Stent Restenosis.</h4><i>Liu S, Zhou Y, Shen Z, Chen H, ... Qiao S, Dissolve ISR Investigators</i><br /><b>Background</b><br />Although use of drug-coated balloons (DCB) is a promising technique, little is known about the clinical efficacy of the Dissolve DCB in drug-eluting stent (DES) in-stent restenosis (ISR).<br /><b>Objectives</b><br />This study sought to evaluate the efficacy and safety of the Dissolve DCB in patients with DES ISR.<br /><b>Methods</b><br />This was a prospective, multicenter, randomized, noninferiority trial comparing Dissolve DCB with SeQuent Please DCB in patients with DES ISR. Angiographic and clinical follow-up was planned at 9 months in all patients. The primary endpoint was 9-month in-segment late loss.<br /><b>Results</b><br />A total of 260 patients with ISR from 10 Chinese sites were included (Dissolve DCB, n = 128; SeQuent Please DCB, n = 132). Nine-month in-segment late loss was 0.50 ± 0.06 mm with Dissolve DCB vs 0.47 ± 0.07 mm with SeQuent Please DCB; the 1-sided 97.5% upper confidence limit of the difference was 0.18 mm (P for noninferiority = 0.03). Rates of target lesion failure and binary restenosis were numerical higher in the Dissolve DCB cohort compared with the SeQuent Please DCB cohort at 9 months (17.5% vs 10.7%; P = 0.12; 23.4% vs 16.4%; P = 0.19, respectively). At 9 months, major adverse cardiac and cerebrovascular events occurred in 36 patients (28.3%) vs 30 patients (22.9%) in the Dissolve DCB and SeQuent Please DCB groups, respectively.<br /><b>Conclusions</b><br />In this head-to-head randomized trial, the Dissolve DCB was noninferior to the SeQuent Please DCB for 9-month in-segment late loss. However, Dissolve DCB with its numerical increase in target lesion failure and binary restenosis warrants assessment in larger clinical trials (A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary In-Stent Restenosis; NCT03373695).<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>JACC Cardiovasc Interv: 10 Apr 2023; 16:759-767</small></div>

<div><h4>Assessment of Paclitaxel Drug-Coated Balloon Only Angioplasty in STEMI.</h4><i>Merinopoulos I, Gunawardena T, Corballis N, Bhalraam U, ... Vassiliou VS, Eccleshall SC</i><br /><b>Background</b><br />Primary percutaneous coronary intervention (pPCI) with drug-eluting stents (DES) has emerged as the standard of care, but stent-related events have persisted. Drug-coated balloon (DCB)-only angioplasty is an emerging technology, although it is not fully evaluated compared with DES in the context of pPCI.<br /><b>Objectives</b><br />The aim of this study was to investigate the safety of DCB-only angioplasty compared with second-generation DES in pPCI.<br /><b>Methods</b><br />All-cause mortality and net adverse cardiac events (cardiovascular mortality, acute coronary syndrome, ischemic stroke or transient ischemic attack, major bleeding, and unplanned target lesion revascularization [TLR]) were compared among all patients treated with DCBs only or with second-generation DES only for first presentation of ST-segment elevation myocardial infarction (STEMI) due to de novo disease between January 1, 2016, and November 15, 2019. Patients treated with both DCBs and DES were excluded. Data were analyzed using Cox regression models, Kaplan-Meier estimator plots and propensity score matching.<br /><b>Results</b><br />Among 1,139 patients with STEMI due to de novo disease, 452 were treated with DCBs and 687 with DES. After a median follow-up period of >3 years, all-cause mortality was 49 of 452 and 62 of 687 in the DCB and DES groups, respectively (P = 0.18). On multivariable Cox regression analysis, there was no difference in mortality between DCBs and DES in the full and propensity score-matched cohorts. Age, frailty risk, history of heart failure, and family history of ischemic heart disease remained significant independent predictors of mortality. There was no difference in any of the secondary endpoints, including unplanned TLR.<br /><b>Conclusions</b><br />DCB-only angioplasty appears safe compared with DES for STEMI in terms of all-cause mortality and all net adverse cardiac events, including unplanned TLR. DCB may be an efficacious and safe alternative to DES in selected patient groups. (Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty; NCT04482972).<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 10 Apr 2023; 16:771-779</small></div>

<div><h4>Abbreviated or Standard Antiplatelet Therapy in HBR Patients: Final 15-Month Results of the MASTER-DAPT Trial.</h4><i>Landi A, Heg D, Frigoli E, Vranckx P, ... Valgimigli M, MASTER DAPT Investigators</i><br /><b>Background</b><br />Clinical outcomes and treatment selection after completing the randomized phase of modern trials, investigating antiplatelet therapy (APT) after percutaneous coronary intervention (PCI), are unknown.<br /><b>Objectives</b><br />The authors sought to investigate cumulative 15-month and 12-to-15-month outcomes after PCI during routine care in the MASTER DAPT trial.<br /><b>Methods</b><br />The MASTER DAPT trial randomized 4,579 high bleeding risk patients to abbreviated (n = 2,295) or standard (n = 2,284) APT regimens. Coprimary outcomes were net adverse clinical outcomes (NACE) (all-cause death, myocardial infarction, stroke, and BARC 3 or 5 bleeding); major adverse cardiac and cerebral events (MACCE) (all-cause death, myocardial infarction, and stroke); and BARC type 2, 3, or 5 bleeding.<br /><b>Results</b><br />At 15 months, prior allocation to a standard APT regimen was associated with greater use of intensified APT; NACE and MACCE did not differ between abbreviated vs standard APT (HR: 0.92 [95% CI: 0.76-1.12]; P = 0.399 and HR: 0.94 [95% CI: 0.76-1.17]; P = 0.579; respectively), as during the routine care period (HR: 0.81 [95% CI: 0.50-1.30]; P = 0.387 and HR: 0.74 [95% CI: 0.43-1.26]; P = 0.268; respectively). BARC 2, 3, or 5 was lower with abbreviated APT at 15 months (HR: 0.68 [95% CI: 0.56-0.83]; P = 0.0001) and did not differ during the routine care period. The treatment effects during routine care were consistent with those observed within 12 months after PCI.<br /><b>Conclusions</b><br />At 15 months, NACE and MACCE did not differ in the 2 study groups, whereas the risk of major or clinically relevant nonmajor bleeding remained lower with abbreviated compared with standard APT. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 10 Apr 2023; 16:798-812</small></div>

<div><h4>Genetic-Guided Oral P2Y Inhibitor Selection and Cumulative Ischemic Events After Percutaneous Coronary Intervention.</h4><i>Ingraham BS, Farkouh ME, Lennon RJ, So D, ... Rihal C, Pereira NL</i><br /><b>Background</b><br />Genetic-guided P2Y<sub>12</sub> inhibitor selection has been proposed to reduce ischemic events by identifying CYP2C19 loss-of-function (LOF) carriers at increased risk with clopidogrel treatment after percutaneous coronary intervention (PCI). A prespecified analysis of TAILOR-PCI (Tailored Antiplatelet Therapy Following PCI) evaluated the effect of genetic-guided P2Y<sub>12</sub> inhibitor therapy on cumulative ischemic and bleeding events.<br /><b>Objectives</b><br />Here, the authors detail a prespecified analysis of cumulative endpoints. The primary endpoint was cumulative incidence rate of ischemic events at 12 months. Cumulative incidence of major and minor bleeding was a secondary endpoint. Cox proportional hazards models as adapted by Wei, Lin, and Weissfeld were used to estimate the effect of this strategy on all observed events.<br /><b>Methods</b><br />The TAILOR-PCI trial was a prospective trial including 5,302 post-PCI patients with acute and stable coronary artery disease (CAD) who were randomized to genetic-guided P2Y<sub>12</sub> inhibitor or conventional clopidogrel therapy. In the genetic-guided group, LOF carriers were prescribed ticagrelor, whereas noncarriers received clopidogrel. TAILOR-PCI\'s primary analysis was time to first event in LOF carriers.<br /><b>Results</b><br />Among 5,276 patients (median age 62 years; 25% women; 82% acute CAD; 18% stable CAD), 1,849 were LOF carriers (903 genetic-guided; 946 conventional therapy). The cumulative primary endpoint was significantly reduced in the genetic-guided group compared with the conventional therapy (HR: 0.61; 95% CI: 0.41-0.89; P = 0.011) with no significant difference in cumulative incidence of major or minor bleeding (HR: 1.36; 95% CI: 0.67-2.76; P = 0.39).<br /><b>Conclusions</b><br />Among CYP2C19 LOF carriers undergoing PCI, a genetic-guided strategy resulted in a statistically significant reduction in cumulative ischemic events without a significant difference in bleeding. (Tailored Antiplatelet Therapy Following PCI [TAILOR-PCI]; NCT01742117).<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>JACC Cardiovasc Interv: 10 Apr 2023; 16:816-825</small></div>

<div><h4>Peridevice Leak After Left Atrial Appendage Occlusion: Incidence, Mechanisms, Clinical Impact, and Management.</h4><i>Alkhouli M, De Backer O, Ellis CR, Nielsen-Kudsk JE, ... Lakkireddy D, Holmes DR</i><br /><AbstractText>Left atrial appendage occlusion is an increasingly adopted stroke prevention strategy in patients with atrial fibrillation. However, peridevice leaks after the procedure are not infrequent and have recently been shown to confer a higher risk for subsequent ischemic events. In this paper, the authors review the available research on the frequency, mechanisms, clinical significance, and management of peridevice leak after percutaneous left atrial appendage occlusion.</AbstractText><br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 27 Mar 2023; 16:627-642</small></div>

<div><h4>Impact of Computational Modeling on Transcatheter Left Atrial Appendage Closure Efficiency and Outcomes.</h4><i>De Backer O, Iriart X, Kefer J, Nielsen-Kudsk JE, ... Søndergaard L, Garot P</i><br /><b>Background</b><br />When performing transcatheter left atrial appendage (LAA) closure, peridevice leaks and device-related thrombus (DRT) have been associated with worse clinical outcomes-hence, their risk should be mitigated.<br /><b>Objectives</b><br />The authors sought to assess whether use of preprocedural computational modeling impacts procedural efficiency and outcomes of transcatheter LAA closure.<br /><b>Methods</b><br />The PREDICT-LAA trial (NCT04180605) is a prospective, multicenter, randomized trial in which 200 patients were 1:1 randomized to standard planning vs cardiac computed tomography (CT) simulation-based planning of LAA closure with Amplatzer Amulet. The artificial intelligence-enabled CT-based anatomical analyses and computer simulations were provided by FEops (Belgium).<br /><b>Results</b><br />All patients had a preprocedural cardiac CT, 197 patients underwent LAA closure, and 181 of these patients had a postprocedural CT scan (standard, n = 91; CT + simulation, n = 90). The composite primary endpoint, defined as contrast leakage distal of the Amulet lobe and/or presence of DRT, was observed in 41.8% in the standard group vs 28.9% in the CT + simulation group (relative risk [RR]: 0.69; 95% CI: 0.46-1.04; P = 0.08). Complete LAA closure with no residual leak and no disc retraction into the LAA was observed in 44.0% vs 61.1%, respectively (RR: 1.44; 95% CI: 1.05-1.98; P = 0.03). In addition, use of computer simulations resulted in improved procedural efficiency with use of fewer Amulet devices (103 vs 118; P < 0.001) and fewer device repositionings (104 vs 195; P < 0.001) in the CT + simulation group.<br /><b>Conclusions</b><br />The PREDICT-LAA trial demonstrates the possible added value of artificial intelligence-enabled, CT-based computational modeling when planning for transcatheter LAA closure, leading to improved procedural efficiency and a trend toward better procedural outcomes.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 27 Mar 2023; 16:655-666</small></div>

<div><h4>Commissural Alignment With ACURATE neo2 Valve in an Unselected Population.</h4><i>Meduri CU, Rück A, Linder R, Verouhis D, ... Daher D, Saleh N</i><br /><b>Background</b><br />Commissural alignment has become an important topic in transcatheter aortic valve replacement (TAVR) because it may improve coronary access, facilitate future valve procedures, and possibly improve valve durability. The efficacy of commissural alignment with ACURATE neo2 has not yet been shown in a large population.<br /><b>Objectives</b><br />The authors sought to determine the feasibility and success of attempting commissural alignment in an unselected TAVR population treated with the ACURATE neo2 prosthetic heart valve.<br /><b>Methods</b><br />A total of 170 consecutive patients underwent TAVR with a dedicated implantation technique to align the TAVR valve to the native valve. Using right-left overlap and 3-cusp views, valve orientation was adjusted by rotation of the unexpanded valve at the level of the aortic root. Effectiveness was assessed postprocedure as the degree of misalignment determined by analyzing fluoroscopic valve orientation to corresponding cusp orientation on preprocedural computed tomography. Safety endpoints included mortality, stroke/transient ischemic attack, and additional complications through 30 days.<br /><b>Results</b><br />Of 170 patients, 167 (98.2%) could be analyzed for alignment, and all 170, for safety outcomes. Most patients (97%) had successful alignment (≤ mild misalignment), with 80% with commissural alignment, while the degrees of misalignment were 17% mild, 1.2% moderate, 1.8% severe.<br /><b>Conclusions</b><br />In this large evaluation of a commissural alignment technique, alignment was achieved in nearly all patients without safety concerns or impact to procedure duration. Commissural alignment appears effective and safe across all patients with this novel technique.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 27 Mar 2023; 16:670-677</small></div>

<div><h4>30-Day Clinical Outcomes of a Self-Expanding Transcatheter Aortic Valve: The International PORTICO NG Study.</h4><i>Reardon MJ, Chehab B, Smith D, Walton AS, ... Bates N, Søndergaard L</i><br /><b>Background</b><br />The self-expanding, intra-annular Navitor (Abbott Structural Heart) valve includes an outer cuff to reduce paravalvular leak (PVL) and large stent cells for future coronary access.<br /><b>Objectives</b><br />The purpose of the PORTICO NG (Evaluation of the Portico NG [Next Generation] Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis) study is to evaluate the safety and effectiveness of the Navitor valve in patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk.<br /><b>Methods</b><br />PORTICO NG is a prospective, multicenter, global study with follow-up at 30 days, 1 year, and annually through 5 years. The primary endpoints are all-cause mortality and moderate or greater PVL at 30 days. Valve Academic Research Consortium-2 events and valve performance are assessed by an independent clinical events committee and echocardiographic core laboratory.<br /><b>Results</b><br />A total of 260 subjects were treated at 26 clinical sites across Europe, Australia, and the United States between September 2019 and August 2022. The mean age was 83.4 ± 5.4 years, 57.3% were female, and the average Society of Thoracic Surgeons score was 3.9% ± 2.1%. At 30 days, the rate of all-cause mortality was 1.9%, and no subjects had moderate or greater PVL. The rate of disabling stroke was 1.9%, life-threatening bleeding was 3.8%, stage 3 acute kidney injury was 0.8%, major vascular complications were 4.2%, and new permanent pacemaker implantation was 19.0%. Hemodynamic performance included a mean gradient of 7.4 ± 3.5 mm Hg and an effective orifice area of 2.00 ± 0.47 cm<sup>2</sup>.<br /><b>Conclusions</b><br />The Navitor valve is safe and effective for the treatment of subjects with severe aortic stenosis who are at high or greater risk for surgery, which is supported by low rates of adverse events and PVL. (Evaluation of the Portico NG [Next Generation] Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis [PORTICO NG]; NCT04011722).<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 27 Mar 2023; 16:681-689</small></div>

<div><h4>Leaflet Morphology and its Implications for Direct Transcatheter Annuloplasty of Tricuspid Regurgitation.</h4><i>Körber MI, Roder F, Gerçek M, Koell B, ... Baldus S, Pfister R</i><br /><b>Background</b><br />Leaflet morphology has been associated with treatment success in edge-to-edge repair of tricuspid regurgitation (TR), but the impact on annuloplasty is unclear.<br /><b>Objectives</b><br />The authors sought to examine the association of leaflet morphology with efficacy and safety of direct annuloplasty in TR.<br /><b>Methods</b><br />The authors analyzed patients who underwent catheter-based direct annuloplasty with the Cardioband at 3 centers. Leaflet morphology was assessed according to number and location of leaflets by echocardiography. Patients with simple morphology (2 or 3 leaflets) were compared with complex morphology (>3 leaflets).<br /><b>Results</b><br />The study included 120 patients (median age 80 years) with ≥severe TR. A total of 48.3% of patients had a 3-leaflet morphology, 5% a 2-leaflet morphology, and 46.7% had >3 tricuspid leaflets. Baseline characteristics did not differ relevantly between groups except for a higher incidence of torrential TR grade (50 vs 26.6%) in complex morphologies. Postprocedural improvement of 1 (90.6% vs 92.9%) and 2 (71.9% vs 67.9%) TR grades was not significantly different between groups, but patients with complex morphology had more often residual TR ≥3 at discharge (48.2 vs 26.6%; P = 0.014). This difference did not remain significant (P = 0.112) after adjusting for baseline TR severity, coaptation gap, and nonanterior jet localization. Safety endpoints including complications of the right coronary artery, and technical success did not show significant differences.<br /><b>Conclusions</b><br />Efficacy and safety of transcatheter direct annuloplasty using Cardioband are not affected by leaflet morphology. Assessment of leaflet morphology should be part of procedural planning in patients with TR and might help to individually tailor repair techniques to patient anatomy.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 27 Mar 2023; 16:693-702</small></div>

<div><h4>SCAI/HRS Expert Consensus Statement on Transcatheter Left Atrial Appendage Closure.</h4><i>Saw J, Holmes DR, Cavalcante JL, Freeman JV, ... Wang DD, Whisenant BK</i><br /><AbstractText>Exclusion of the left atrial appendage to reduce thromboembolic risk related to atrial fibrillation was first performed surgically in 1949. Over the past 2 decades, the field of transcatheter endovascular left atrial appendage closure (LAAC) has rapidly expanded, with a myriad of devices approved or in clinical development. The number of LAAC procedures performed in the United States and worldwide has increased exponentially since the Food and Drug Administration approval of the WATCHMAN (Boston Scientific) device in 2015. The Society for Cardiovascular Angiography & Interventions (SCAI) has previously published statements in 2015 and 2016 providing societal overview of the technology and institutional and operator requirements for LAAC. Since then, results from several important clinical trials and registries have been published, technical expertise and clinical practice have matured over time, and the device and imaging technologies have evolved. Therefore, SCAI prioritized the development of an updated consensus statement to provide recommendations on contemporary, evidence-based best practices for transcatheter LAAC focusing on endovascular devices.</AbstractText><br /><br />Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 17 Mar 2023; epub ahead of print</small></div>

<div><h4>Left Atrial to Coronary Sinus Shunting for Treatment of Symptomatic Heart Failure.</h4><i>Hibbert B, Zahr F, Simard T, Labinaz M, ... Gray WA, ALTFLOW investigators</i><br /><b>Background</b><br />Heart failure (HF) is associated with both mortality and a significant decline in health status. Inter-atrial shunting is increasingly being investigated as a novel therapeutic option.<br /><b>Objectives</b><br />The ALT FLOW Early Feasibility Study was designed to evaluate the safety of the Edwards left atrial to coronary sinus APTURE<sup>TM</sup> Transcatheter Shunt System in patients with symptomatic HF.<br /><b>Methods</b><br />18 centers enrolled patients with symptomatic HF with a pulmonary capillary wedge pressure (PCWP) >15mmHg at rest or 25mmHg during exercise.<br /><b>Results</b><br />Between May 2018 and September 2022, 87 patients underwent attempted APTURE<sup>TM</sup> shunt implantation. Mean age was 71 years, and 53% were male. At baseline mean LVEF was 59% with 90% of the patients being NYHA III. Device success was achieved in 78 (90%) of patients with no device occlusions or associated adverse events identified after implantation. The primary safety outcome occurred in only 2 (2.3%) patients at 30 days. At 6 months health status improved: 68% of participants achieved NYHA I-II status, with a 23-point improvement (p<0.0001, 95% CI [17, 29]) in the Kansas City Cardiomyopathy Questionnaire overall summary score. Also at 6 months, 20-watt exercise pulmonary capillary wedge pressure was -7mmHg lower (p<0.0001, 95% CI [-11, -4]) without change in right atrial pressure or other right heart function indices.<br /><b>Conclusions</b><br />In this single-arm experience, the APTURE<sup>TM</sup> Transcatheter Shunt System in patients with symptomatic HF was observed to be safe and resulted in reduction in PCWP and clinically meaningful improvements in HF symptoms and quality of life indices.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>JACC Cardiovasc Interv: 13 Mar 2023; epub ahead of print</small></div>

<div><h4>Best Practices for Cardiac Catheterization Laboratory Morbidity and Mortality Conferences.</h4><i>Blankenship JC, Doll JA, Latif F, Truesdell AG, ... Vetrovec G, Welt F</i><br /><AbstractText>Cardiac catheterization laboratory (CCL) morbidity and mortality conferences (MMCs) are a critical component of CCL quality improvement programs and are important for the education of cardiology trainees and the lifelong learning of CCL physicians and team members. Despite their fundamental role in the functioning of the CCL, no consensus exists on how CCL MMCs should identify and select cases for review, how they should be conducted, and how results should be used to improve CCL quality. In addition, medicolegal ramifications of CCL MMCs are not well understood. This document from the American College of Cardiology\'s Interventional Section attempts to clarify current issues and options in the conduct of CCL MMCs and to recommend best practices for their conduct.</AbstractText><br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 13 Mar 2023; 16:503-514</small></div>

<div><h4>Deformation of Transcatheter Heart Valve Following Valve-in-Valve Transcatheter Aortic Valve Replacement: Implications for Hemodynamics.</h4><i>Fukui M, Sorajja P, Cavalcante JL, Thao KR, ... Lesser JR, Bapat VN</i><br /><b>Background</b><br />Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) may be associated with adverse hemodynamics, which might affect clinical outcomes.<br /><b>Objectives</b><br />This study sought to evaluate the extent and predictors of transcatheter heart valve (THV) deformity in ViV TAVR and the relation to postprocedural hemodynamics.<br /><b>Methods</b><br />We examined 53 patients who underwent ViV TAVR in surgical heart valves with self-expanding Evolut prostheses. THV deformation was examined using cardiac computed tomography prospectively performed 30 days after ViV TAVR, and correlated with 30-day echocardiographic hemodynamic data.<br /><b>Results</b><br />Near complete expansion of the functional portion of the implanted ViV prostheses (ie, >90%) was observed in 16 (30.2%) patients. Factors related to greater expansion of the functional portion and consequently larger neosinus volume were absence of polymer surgical frame, higher implantation and use of balloon aortic valvuloplasty or bioprosthetic valve fracture during the procedure (all P < 0.05). Underexpansion of the functional portion, but not the valve inflow frame, was closely associated with mean gradient and effective orifice area at 30 days on echocardiography, with and without adjustment for the sizes of the THV and surgical heart valve.<br /><b>Conclusions</b><br />Underexpansion of the functional portion of THV prostheses is common during ViV TAVR, occurs more frequently with deep implantation and the presence of a polymer surgical stent frame, and is associated with worse postprocedural hemodynamics. Procedural techniques, such as higher implantation and balloon postdilatation, may be used to help overcome problems with THV underexpansion and improve clinical outcomes.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 13 Mar 2023; 16:515-526</small></div>

<div><h4>Outcomes of Bioprosthetic Valve Fracture in Patients Undergoing Valve-in-Valve TAVR.</h4><i>Chhatriwalla AK, Allen KB, Depta JP, Rodriguez E, ... Bapat V, Garcia S</i><br /><b>Background</b><br />Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) is increasingly used to treat degenerated surgical bioprostheses. Bioprosthetic valve fracture (BVF) has been shown to improve hemodynamic status in VIV TAVR in case series. However, the safety and efficacy of BVF are unknown.<br /><b>Objectives</b><br />The primary objective of this study was to assess the safety and efficacy of VIV TAVR using SAPIEN 3 and SAPIEN 3 Ultra valves with or without BVF using data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry.<br /><b>Methods</b><br />The primary outcome was in-hospital mortality. Secondary outcomes included echocardiography-derived valve gradient and aortic valve area. Inverse probability of treatment weighting was used to adjust for baseline characteristics.<br /><b>Results</b><br />A total of 2,975 patients underwent VIV TAVR from December 15, 2020, to March 31, 2022. BVF was attempted in 619 patients (21%). In adjusted analyses, attempted BVF was associated with higher in-hospital mortality (OR: 2.51; 95% CI: 1.30-4.84) and life-threatening bleeding (OR: 2.55; 95% CI: 1.44-4.50). At discharge, VIV TAVR with attempted BVF was associated with larger aortic valve area (1.6 cm<sup>2</sup> vs 1.4 cm<sup>2</sup>; P < 0.01) and lower mean gradient (16.3 mm Hg vs 19.2 mm Hg; P < 0.01). When BVF was compared with no BVF according to timing (before vs after transcatheter heart valve implantation), BVF after transcatheter heart valve implantation was associated with improved hemodynamic status and similar mortality.<br /><b>Conclusions</b><br />BVF as an adjunct to VIV TAVR with the SAPIEN 3 and SAPIEN 3 Ultra valves is associated with a higher risk for in-hospital mortality and significant bleeding and modest improvements in echocardiography-derived hemodynamic status. The timing of BVF is an important determinant of safety and efficacy.<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 13 Mar 2023; 16:530-539</small></div>

<div><h4>Hemodynamic and Mid-Term Outcomes for Transcatheter Aortic Valve Replacement in Degenerated Internally Stented Valves.</h4><i>AlBadri A, Joseph J, Patel V, Patel D, ... Jilaihawi H, Makkar R</i><br /><b>Background</b><br />Valve-in-valve (ViV) transcatheter aortic valve replacement is indicated in patients undergoing repeat intervention for degenerative aortic valve bioprostheses. Patients with internally stented valves (ie, Mitroflow and Trifecta) are at high risk for coronary artery obstruction during ViV procedures because of valve design, as the leaflets are mounted outside the valve stent.<br /><b>Objectives</b><br />The aim of this study was to compare the hemodynamic and clinical outcomes of transcatheter aortic valve replacement within internally stented valves (ViV-IS) vs other surgical valves (ViV-OS).<br /><b>Methods</b><br />Baseline characteristics, hemodynamic parameters, and clinical outcomes of patients who underwent ViV-IS were retrospectively collected and compared with those of patients who underwent ViV-OS.<br /><b>Results</b><br />A total of 250 patients (65% men, median Society of Thoracic Surgeons score 4.4% [IQR: 2.2%-8.4%]) were included. Seventy-one patients (28%) underwent ViV-IS, and 179 (72%) patients underwent ViV-OS. Patients who underwent ViV-OS had better periprocedural hemodynamic status compared with those who underwent ViV-IS (median mean gradient 6 [IQR: 2-13] vs 12 [IQR: 6-16]; P < 0.001). This was not significantly different when both groups were matched on the basis of age, sex, and valve internal diameter size (median mean gradient: 18 [IQR: 13-25] for ViV-OS vs 18 [IQR: 11-24] for ViV-IS; P = 0.36). Coronary protection for potential occlusion was performed more in ViV-IS vs ViV-OS pr (79% vs 6%, respectively; P < 0.001). Patients who underwent ViV-IS had a higher risk for coronary occlusion, requiring stent deployment, compared with those who underwent ViV-OS (54% vs 3%, respectively; P < 0.001. There was no difference in mortality at 3 years between the 2 groups (P = 0.59).<br /><b>Conclusions</b><br />Patients who underwent ViV-IS had a very high incidence of coronary compromise that can be safely and effectively treated. In the setting of a systematic coronary protection strategy, ViV-OS and ViV-IS provide similar mid-term outcome, and periprocedural hemodynamic status (following adjustment for age, sex, and true internal diameter).<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 13 Mar 2023; 16:542-554</small></div>

<div><h4>Clinical Impact of Standardized TAVR Technique and Care Pathway: Insights From the Optimize PRO Study.</h4><i>Grubb KJ, Gada H, Mittal S, Nazif T, ... Li S, Yakubov SJ</i><br /><b>Background</b><br />Procedural success and clinical outcomes after transcatheter aortic valve replacement (TAVR) have improved, but residual aortic regurgitation (AR) and new permanent pacemaker implantation (PPI) rates remain variable because of a lack of uniform periprocedural management and implantation.<br /><b>Objectives</b><br />The Optimize PRO study evaluates valve performance and procedural outcomes using an \"optimized\" TAVR care pathway and the cusp overlap technique (COT) in patients receiving the Evolut PRO/PRO+ (Medtronic) self-expanding valves.<br /><b>Methods</b><br />Optimize PRO, a nonrandomized, prospective, postmarket study conducted in the United States, Canada, Europe, Middle East, and Australia, is enrolling patients with severe symptomatic aortic stenosis and no pre-existing pacemaker. Sites follow a standardized TAVR care pathway, including early discharge and a conduction disturbance management algorithm, and transfemoral deployment using the COT.<br /><b>Results</b><br />A total of 400 attempted implants from the United States and Canada comprised the main cohort of this second interim analysis. The mean age was 78.7 ± 6.6 years, and the mean Society of Thoracic Surgeons predictive risk of mortality was 3.0 ± 2.4. The median length of stay was 1 day. There were no instances of moderate or severe AR at discharge. At 30 days, all-cause mortality or stroke was 3.8%, all-cause mortality was 0.8%, disabling stroke was 0.7%, hospital readmission was 10.1%, and cardiovascular rehospitalization was 6.1%. The new PPI rate was 9.8%, 5.8% with 4-step COT compliance. In the multivariable model, right bundle branch block and the depth of the implant increased the risk of PPI, whereas using the 4-step COT lowered 30-day PPI.<br /><b>Conclusions</b><br />The use of the TAVR care pathway and COT resulted in favorable clinical outcomes with no moderate or severe AR and low PPI rates at 30 days while facilitating early discharge and reproducible outcomes across various sites and operators. (Optimize PRO; NCT04091048).<br /><br />Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 13 Mar 2023; 16:558-570</small></div>

<div><h4>Intraprocedural Residual Mitral Regurgitation and Survival After Transcatheter Edge-to-Edge Repair: Prospective German Multicenter Registry (MITRA-PRO).</h4><i>Boekstegers P, Hausleiter J, Schmitz T, Bufe A, ... Schneider S, MITRA-PRO Investigators</i><br /><b>Background</b><br />Residual mitral regurgitation (MR) is thought to be an important predictor of long-term survival following transcatheter edge-to-edge repair (TEER). Intraprocedural MR assessment using transesophageal echocardiography could be limited by image quality, hemodynamics, and patient sedation. The MitraScore is a validated multimodal approach for intraprocedural MR assessment during TEER.<br /><b>Objectives</b><br />This study aimed to assess the impact of residual MR using the MitraScore on 1-year mortality.<br /><b>Methods</b><br />Patients undergoing mitral TEER were eligible for inclusion in the prospective, multicenter MITRA-PRO registry (A Prospective Registry Study on 1-Year Mortality and the Prognostic Significance of MitraScore After MitraClip Implantation in Patients With Mitral Regurgitation). Patients with a MitraScore ≤3 were defined as patients with mild residual MR after mitral TEER, whereas a MitraScore ≥4 was considered as relevant residual MR. Mortality, rehospitalization, and major adverse events were assessed 1 year after TEER.<br /><b>Results</b><br />A MitraScore ≤3 was found in 1,059 patients (71.0%), whereas 432 patients revealed a MitraScore ≥4 (29.0%). One-year mortality was significantly lower in patients with nonrelevant residual MR (MitraScore ≤3 14.6% vs MitraScore≥4 22.1%). An almost linear relationship between intraprocedural MitraScore after TEER and mortality was observed. The combined clinical endpoint of mortality and rehospitalization within the 1-year follow-up was also significantly lower in the MitraScore ≤3 group (31.5%) than in the MitraScore ≥4 group (40.8%). A subgroup analysis confirmed the predictive value of the MitraScore in patients with primary, secondary, or mixed MR etiologies.<br /><b>Conclusions</b><br />Residual MR assessed by intraprocedural MitraScore after TEER predicts 1-year mortality and rehospitalization. Therefore, the multimodal MitraScore improves MR assessment during mitral TEER and might improve patient survival.(A Prospective Registry Study on 1-Year Mortality and the Prognostic Significance of MitraScore After MitraClip Implantation in Patients With Mitral Regurgitation [MITRA-PRO]; DRKS00012288).<br /><br />Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.<br /><br /><small>JACC Cardiovasc Interv: 13 Mar 2023; 16:574-585</small></div>

<div><h4>Contemporary Outcomes Following Transcatheter Edge-to-Edge Repair: 1-Year Results From the EXPAND Study.</h4><i>Kar S, von Bardeleben RS, Rottbauer W, Mahoney P, ... Asch FM, Maisano F</i><br /><b>Background</b><br />The third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system was introduced to assist in leaflet grasping with the longer clip arms of MitraClip XTR and to improve ease of use with the modified delivery catheter.<br /><b>Objectives</b><br />The EXPAND study evaluated contemporary real-world outcomes in subjects with mitral regurgitation (MR) treated with the third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system.<br /><b>Methods</b><br />EXPAND is a prospective, multicenter, international, single-arm study that enrolled patients with primary MR and secondary MR at 57 centers. Follow-up was conducted through 12 months. Echocardiograms were analyzed by an echocardiographic core laboratories. Study outcomes included: MR severity, functional capacity measured by New York Heart Association functional class, quality of life measured by Kansas City Cardiomyopathy Questionnaire, heart failure hospitalizations, all-cause mortality.<br /><b>Results</b><br />1,041 patients were enrolled from April 2018 through March 2019, of which 50.5% had primary or mixed etiology. Implant success was 98.9%; 1.5 ± 0.6 clips were implanted per subject. Significant MR reduction from baseline (≥MR 3+: 56.0%) to 30 days (≤MR 1+:88.8%) was maintained through 1 year (MR ≤1+: 89.2%). A total of 84.5% and 93.0% of subjects in primary MR and secondary MR, respectively, had ≤1+ MR at 1 year. Significant improvements were observed in clinical outcomes (New York Heart Association functional class I/II in 80.3%, +21.6 improvement in Kansas City Cardiomyopathy Questionnaire score) at 1 year. All-cause mortality and heart failure hospitalizations at 1 year were 14.9% and 18.9%, respectively, which was significantly lower than previous studies.<br /><b>Conclusions</b><br />The study demonstrates treatment with the third-generation system resulted in substantial reduction of MR in a contemporary real-world practice, compared with the results of earlier EVEREST and COAPT trials.(The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices [EXPAND]; NCT03502811).<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>JACC Cardiovasc Interv: 13 Mar 2023; 16:589-602</small></div>

<div><h4>Prognostic Value of Tricuspid Valve Gradient After Transcatheter Edge-to-Edge Repair: Insights From the TriValve Registry.</h4><i>Coisne A, Scotti A, Taramasso M, Granada JF, ... Hahn RT, Latib A</i><br /><b>Background</b><br />Data regarding the impact of the tricuspid valve gradient (TVG) after tricuspid transcatheter edge-to-edge repair (TEER) are scarce.<br /><b>Objectives</b><br />This study sought to evaluate the association between the mean TVG and clinical outcomes among patients who underwent tricuspid TEER for significant tricuspid regurgitation.<br /><b>Methods</b><br />Patients with significant tricuspid regurgitation who underwent tricuspid TEER within the TriValve (International Multisite Transcatheter Tricuspid Valve Therapies) registry were divided into quartiles based on the mean TVG at discharge. The primary endpoint was the composite of all-cause mortality and heart failure hospitalization. Outcomes were assessed up to the 1-year follow-up.<br /><b>Results</b><br />A total of 308 patients were included from 24 centers. Patients were divided into quartiles of the mean TVG as follows: quartile 1 (n = 77), 0.9 ± 0.3 mm Hg; quartile 2 (n = 115), 1.8 ± 0.3 mm Hg; quartile 3 (n = 65), 2.8 ± 0.3 mm Hg; and quartile 4 (n = 51), 4.7 ± 2.0 mm Hg. The baseline TVG and the number of implanted clips were associated with a higher post-TEER TVG. There was no significant difference across TVG quartiles in the 1-year composite endpoint (quartiles 1-4: 35%, 30%, 40%, and 34%, respectively; P = 0.60) or the proportion of patients in New York Heart Association class III to IV at the last follow-up (P = 0.63). The results were similar after adjustment for clinical and echocardiographic characteristics (composite endpoint quartile 4 vs quartile 1-quartile 3 adjusted HR: 1.05; 95% CI: 0.52-2.12; P = 0.88) or exploring post-TEER TVG as a continuous variable.<br /><b>Conclusions</b><br />In this retrospective analysis of the TriValve registry, an increased discharge TVG was not significantly associated with adverse outcomes after tricuspid TEER. These findings apply for the explored TVG range and up to the 1-year follow-up. Further investigations on higher gradients and longer follow-up are needed to better guide the intraprocedural decision-making process.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>JACC Cardiovasc Interv: 10 Mar 2023; epub ahead of print</small></div>