Circulation: Cardiovascular Interventions最新文献

{"title":"Finding the Optimal Strategy for Nonculprit Revascularization in Acute Myocardial Infarction: The Role of Angiography-Derived Physiology.","authors":"Natalija Odanovic, Rushi V Parikh, Samit M Shah","doi":"10.1161/CIRCINTERVENTIONS.124.014129","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.124.014129","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141075522","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ACURATE neo2 Versus SAPIEN 3 Ultra Transcatheter Heart Valve in Severe Aortic Valve Calcification: A Propensity-Matched Analysis.","authors":"Clemens Eckel, Won-Keun Kim, Dagmar Sötemann, Christina Grothusen, Vedat Tiyerili, Guido Dohmen, Matthias Renker, Efstratios I Charitos, Christian W Hamm, Yeong-Hoon Choi, Albrecht Elsässer, Helge Möllmann, Johannes Blumenstein","doi":"10.1161/CIRCINTERVENTIONS.123.013608","DOIUrl":"10.1161/CIRCINTERVENTIONS.123.013608","url":null,"abstract":"<p><strong>Background: </strong>Comparative data on transcatheter self-expanding ACURATE neo2 (NEO2) and balloon-expandable SAPIEN 3 Ultra prostheses in technically challenging anatomy of severe aortic valve calcified aortic annuli are scarce.</p><p><strong>Methods: </strong>A total of 1987 patients with severe native aortic stenosis treated with the self-expanding NEO2 (n=1457) or balloon-expandable SAPIEN 3 Ultra (n=530) from January 2017 to April 2023 were evaluated. The primary end point was procedural outcome according to the Valve Academic Research Consortium 3 definitions. Propensity matching defined 219 pairs with severe calcification (calcium density cutoff, 758 AU/cm²) of the native aortic valve.</p><p><strong>Results: </strong>Technical success (90.4% versus 91.8%; risk difference, 1.4% [95% CI, -4.4 to -7.2]; <i>P</i>=0.737) and device success at 30 days (80.8% versus 75.8%; risk difference, -5.0% [95% CI, -13.2 to 3.1]; <i>P</i>=0.246) were comparable between NEO2 and SAPIEN 3 Ultra. The rate of severe prosthesis-patient mismatch (1.1% versus 10.1%; risk difference, 10.0% [95% CI, 4.0-13.9]; <i>P</i><0.001) and mean transvalvular gradient ≥20 mm Hg (2.8% versus 14.3%; risk difference, 11.5% [95% CI, 5.8-17.1]; <i>P</i><0.001) was lower with NEO2. The rate of more-than-mild paravalvular leakage or valve-in-valve due to paravalvular leakage was significantly higher (6.2% versus 0.0%; risk difference, 6.2% [95% CI, -10.1 to -2.7]; <i>P</i>=0.002), and there was a tendency for a higher rate of device embolization or migration (1.8% versus 0.0%; risk difference, -1.8% [95% CI, -4.1 to 0.4]; <i>P</i>=0.123) with NEO2. Multivarate regression revealed no independent impact of transcatheter heart valve selection on device success (odds ratio, 0.93 [95% CI, 0.48-1.77]; <i>P</i>=0.817).</p><p><strong>Conclusions: </strong>In patients with severely calcified annuli, supraannular implantation of NEO2 showed hemodynamic advantages. Nevertheless, NEO2 was associated with a higher incidence of relevant paravalvular leakage and a numerically higher rate of device embolization than SAPIEN 3 Ultra in this particular patient group.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140287020","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Angiogenic Gene Therapy for Refractory Angina: Results of the EXACT Phase 2 Trial.","authors":"Kenta Nakamura, Timothy D Henry, Jay H Traverse, David A Latter, Nahush A Mokadam, Geoffrey A Answini, Adam R Williams, Benjamin C Sun, Christopher R Burke, Faisal G Bakaeen, Marcelo F DiCarli, Bernard R Chaitman, Mark W Peterson, Dawn G Byrnes, E Magnus Ohman, Carl J Pepine, Ronald G Crystal, Todd K Rosengart, Elaine Kowalewski, Gary G Koch, Howard C Dittrich, Thomas J Povsic","doi":"10.1161/CIRCINTERVENTIONS.124.014054","DOIUrl":"10.1161/CIRCINTERVENTIONS.124.014054","url":null,"abstract":"<p><strong>Background: </strong>XC001 is a novel adenoviral-5 vector designed to express multiple isoforms of VEGF (vascular endothelial growth factor) and more safely and potently induce angiogenesis. The EXACT trial (Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment) assessed the safety and preliminary efficacy of XC001 in patients with no option refractory angina.</p><p><strong>Methods: </strong>In this single-arm, multicenter, open-label trial, 32 patients with no option refractory angina received a single treatment of XC001 (1×10¹¹ viral particles) via transepicardial delivery.</p><p><strong>Results: </strong>There were no severe adverse events attributed to the study drug. Twenty expected severe adverse events in 13 patients were related to the surgical procedure. Total exercise duration increased from a mean±SD of 359.9±105.55 seconds at baseline to 448.2±168.45 (3 months), 449.2±175.9 (6 months), and 477.6±174.7 (12 months; +88.3 [95% CI, 37.1-139.5], +84.5 [95% CI, 34.1-134.9], and +115.5 [95% CI, 59.1-171.9]). Total myocardial perfusion deficit on positron emission tomography imaging decreased by 10.2% (95% CI, -3.1% to 23.5%), 14.3% (95% CI, 2.8%-25.7%), and 10.2% (95% CI, -0.8% to -21.2%). Angina frequency decreased from a mean±SD 12.2±12.5 episodes to 5.2±7.2 (3 months), 5.1±7.8 (6 months), and 2.7±4.8 (12 months), with an average decrease of 7.7 (95% CI, 4.1-11.3), 6.6 (95% CI, 3.5-9.7), and 8.8 (4.6-13.0) episodes at 3, 6, and 12 months. Angina class improved in 81% of participants at 6 months.</p><p><strong>Conclusions: </strong>XC001 administered via transepicardial delivery is safe and generally well tolerated. Exploratory improvements in total exercise duration, ischemic burden, and subjective measures support a biologic effect sustained to 12 months, warranting further investigation.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT04125732.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":6.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11097950/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140851699","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Value of Single-Projection Angiography-Derived FFR in Noninfarct-Related Artery.","authors":"Woochan Kwon, Ki Hong Choi, Seung Hun Lee, David Hong, Doosup Shin, Hyun Kuk Kim, Keun Ho Park, Eun Ho Choo, Chan Joon Kim, Min Chul Kim, Young Joon Hong, Sung Gyun Ahn, Joon-Hyung Doh, Sang Yeub Lee, Sang Don Park, Hyun-Jong Lee, Min Gyu Kang, Jin-Sin Koh, Yun-Kyeong Cho, Chang-Wook Nam, Hyun Sung Joh, Taek Kyu Park, Jeong Hoon Yang, Young Bin Song, Seung-Hyuk Choi, Myung Ho Jeong, Hyeon-Cheol Gwon, Joo-Yong Hahn, Joo Myung Lee","doi":"10.1161/CIRCINTERVENTIONS.123.013844","DOIUrl":"10.1161/CIRCINTERVENTIONS.123.013844","url":null,"abstract":"<p><strong>Background: </strong>The Murray law-based quantitative flow ratio (μFR) is an emerging technique that requires only 1 projection of coronary angiography with similar accuracy to quantitative flow ratio (QFR). However, it has not been validated for the evaluation of noninfarct-related artery (non-IRA) in acute myocardial infarction (AMI) settings. Therefore, our study aimed to evaluate the diagnostic accuracy of μFR and the safety of deferring non-IRA lesions with μFR >0.80 in the setting of AMI.</p><p><strong>Methods: </strong>μFR and QFR were analyzed for non-IRA lesions of patients with AMI enrolled in the FRAME-AMI trial (Fractional Flow Reserve Versus Angiography-Guided Strategy for Management of Non-Infarction Related Artery Stenosis in Patients With Acute Myocardial Infarction), consisting of fractional flow reserve (FFR)-guided percutaneous coronary intervention and angiography-guided percutaneous coronary intervention groups. The diagnostic accuracy of μFR was compared with QFR and FFR. Patients were classified by the non-IRA μFR value of 0.80 as a cutoff value. The primary outcome was a vessel-oriented composite outcome, a composite of cardiac death, non-IRA-related myocardial infarction, and non-IRA-related repeat revascularization.</p><p><strong>Results: </strong>μFR and QFR analyses were feasible in 443 patients (552 lesions). μFR showed acceptable correlation with FFR (R=0.777; <i>P</i><0.001), comparable C-index with QFR to predict FFR ≤0.80 (μFR versus QFR: 0.926 versus 0.961, <i>P</i>=0.070), and shorter total analysis time (mean, 32.7 versus 186.9 s; <i>P</i><0.001). Non-IRA with μFR >0.80 and deferred percutaneous coronary intervention had a significantly lower risk of vessel-oriented composite outcome than non-IRA with performed percutaneous coronary intervention (3.4% versus 10.5%; hazard ratio, 0.37 [95% CI, 0.14-0.99]; <i>P</i>=0.048).</p><p><strong>Conclusions: </strong>In patients with multivessel AMI, μFR of non-IRA showed acceptable diagnostic accuracy comparable to that of QFR to predict FFR ≤0.80. Deferred non-IRA with μFR >0.80 showed a lower risk of vessel-oriented composite outcome than revascularized non-IRA.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT02715518.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":6.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141075593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Incidence and Impact of Contrast-Associated Acute Kidney Injury in Patients With High-Bleeding Risk Undergoing Percutaneous Coronary Intervention.","authors":"Johny Nicolas, Nicholas Pitaro, Samantha Sartori, Alessandro Spirito, Kenneth F Smith, Birgit Vogel, Annapoorna Kini, George Dangas, Samin K Sharma, Roxana Mehran","doi":"10.1161/CIRCINTERVENTIONS.123.013835","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.123.013835","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141075527","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug-Coated Balloons in the Management of Coronary Artery Disease.","authors":"Serge Korjian, Killian J McCarthy, Emily A Larnard, Donald E Cutlip, Margaret B McEntegart, Ajay J Kirtane, Robert W Yeh","doi":"10.1161/CIRCINTERVENTIONS.123.013302","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.123.013302","url":null,"abstract":"<p><p>Drug-coated balloons (DCBs) are specialized coronary devices comprised of a semicompliant balloon catheter with an engineered coating that allows the delivery of antiproliferative agents locally to the vessel wall during percutaneous coronary intervention. Although DCBs were initially developed more than a decade ago, their potential in coronary interventions has recently sparked renewed interest, especially in the United States. Originally designed to overcome the limitations of conventional balloon angioplasty and stenting, they aim to match or even improve upon the outcomes of drug-eluting stents without leaving a permanent implant. Presently, in-stent restenosis is the condition with the most robust evidence supporting the use of DCBs. DCBs provide improved long-term vessel patency compared with conventional balloon angioplasty and may be comparable to drug-eluting stents without the need for an additional stent layer, supporting their use as a first-line therapy for in-stent restenosis. Beyond the treatment of in-stent restenosis, DCBs provide an additional tool for de novo lesions for a strategy that avoids a permanent metal scaffold, which may be especially useful for the management of technically challenging anatomies such as small vessels and bifurcations. DCBs might also be advantageous for patients with high bleeding risk due to the decreased necessity for extended antiplatelet therapy, and in patients with diabetes and patients with diffuse disease to minimize long-stented segments. Further studies are crucial to confirm these broader applications for DCBs and to further validate safety and efficacy.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141075519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prognostic Impact of Left Atrial Appendage Patency After Device Closure","authors":"Mu Chen, Peng-Cheng Yao, Zhen-Tao Fei, Qun-Shan Wang, Yi-Chi Yu, Peng-Pai Zhang, Wei Li, Rui Zhang, Bin-Feng Mo, Ming-Zhe Zhao, Yi Yu, Mei Yang, Yan Zhao, Chang-Qi Gong, Jian Sun, Yi-Gang Li","doi":"10.1161/circinterventions.123.013579","DOIUrl":"https://doi.org/10.1161/circinterventions.123.013579","url":null,"abstract":"BACKGROUND:The prognostic impact of left atrial appendage (LAA) patency, including those with and without visible peri-device leak (PDL), post–LAA closure in patients with atrial fibrillation, remains elusive.METHODS:Patients with atrial fibrillation implanted with the WATCHMAN 2.5 device were prospectively enrolled. The device surveillance by cardiac computed tomography angiography was performed at 3 months post-procedure. Adverse events, including stroke/transient ischemic attack (TIA), major bleeding, cardiovascular death, all-cause death, and the combined major adverse events (MAEs), were compared between patients with complete closure and LAA patency.RESULTS:Among 519 patients with cardiac computed tomography angiography surveillance at 3 months post–LAA closure, 271 (52.2%) showed complete closure, and LAA patency was detected in 248 (47.8%) patients, including 196 (37.8%) with visible PDL and 52 (10.0%) without visible PDL. During a median of 1193 (787–1543) days follow-up, the presence of LAA patency was associated with increased risks of stroke/TIA (adjusted hazard ratio for baseline differences, 3.22 [95% CI, 1.17–8.83]; <i>P</i>=0.023) and MAEs (adjusted hazard ratio, 1.12 [95% CI, 1.06–1.17]; <i>P</i>=0.003). Specifically, LAA patency with visible PDL was associated with increased risks of stroke/TIA (hazard ratio, 3.66 [95% CI, 1.29–10.42]; <i>P</i>=0.015) and MAEs (hazard ratio, 3.71 [95% CI, 1.71–8.07]; <i>P</i>=0.001), although LAA patency without visible PDL showed higher risks of MAEs (hazard ratio, 3.59 [95% CI, 1.28–10.09]; <i>P</i>=0.015). Incidences of stroke/TIA (2.8% versus 3.0% versus 6.7% versus 22.2%; <i>P</i>=0.010), cardiovascular death (0.9% versus 0% versus 1.7% versus 11.1%; <i>P</i>=0.005), and MAEs (4.6% versus 9.0% versus 11.7% versus 22.2%; <i>P</i>=0.017) increased with larger PDL (0, &gt;0 to ≤3, &gt;3 to ≤5, or &gt;5 mm). Older age and discontinuing antiplatelet therapy at 6 months were independent predictors of stroke/TIA and MAEs in patients with LAA patency.CONCLUSIONS:LAA patency detected by cardiac computed tomography angiography at 3 months post–LAA closure is associated with unfavorable prognosis in patients with atrial fibrillation implanted with WATCHMAN 2.5 device.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03788941.","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140617517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Outcomes of Transcatheter Tricuspid Edge-to-Edge Repair in Patients With Right Ventricular Dysfunction","authors":"Johanna Vogelhuber, Tetsu Tanaka, Refik Kavsur, Tadahiro Goto, Can Öztürk, Miriam Silaschi, Georg Nickenig, Sebastian Zimmer, Marcel Weber, Atsushi Sugiura","doi":"10.1161/circinterventions.123.013156","DOIUrl":"https://doi.org/10.1161/circinterventions.123.013156","url":null,"abstract":"BACKGROUND:We assessed the safety profile of tricuspid transcatheter edge-to-edge repair (TEER) in patients with right ventricular (RV) dysfunction.METHODS:We identified patients undergoing TEER to treat tricuspid regurgitation from June 2015 to October 2021 and assessed tricuspid annular plane systolic excursion (TAPSE) and RV fractional area change (RVFAC). RV dysfunction was defined as TAPSE &lt;17 mm and RVFAC &lt;35%. The primary end point was 30-day mortality after TEER. We also investigated the change in the RV function in the early phase and clinical outcomes at 2 years.RESULTS:The study participants (n=262) were at high surgical risk (EuroSCORE II, 6.2% [interquartile range, 4.0%–10.3%]). Among them, 44 patients met the criteria of RV dysfunction. Thirty-day mortality was 3.2% in patients with normal RV function and 2.3% in patients with RV dysfunction (<i>P</i>=0.99). Tricuspid regurgitation reduction to ≤2+ was consistently achieved irrespective of RV dysfunction (76.5% versus 70.5%; <i>P</i>=0.44). TAPSE and RVFAC declined after TEER in patients with normal RV function (TAPSE, 19.0±4.7 to 17.9±4.5 mm; <i>P</i>=0.001; RVFAC, 46.2%±8.1% to 40.3%±9.7%; <i>P</i>&lt;0.001). In contrast, those parameters were unchanged or tended to increase in patients with RV dysfunction (TAPSE, 13.2±2.3 to 15.3±4.7 mm; <i>P</i>=0.011; RVFAC, 29.6%±4.1% to 31.6%±8.3%; <i>P</i>=0.14). Two years after TEER, compared with patients with normal RV function, patients with RV dysfunction had significantly higher mortality (27.0% versus 56.3%; <i>P</i>&lt;0.001).CONCLUSIONS:TEER was safe and feasible to treat tricuspid regurgitation in patients with RV dysfunction. The decline in the RV function was observed in patients with normal RV function but not in patients with RV dysfunction.","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140616146","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cardiac Damage in Degenerative Mitral Regurgitation Treated With Transcatheter Mitral Edge-to-Edge Repair","authors":"Atsushi Sugiura, Masanori Yamamoto, Mike Saji, Masahiko Asami, Yusuke Enta, Masaki Nakashima, Shinichi Shirai, Masaki Izumo, Shingo Mizuno, Yusuke Watanabe, Makoto Amaki, Kazuhisa Kodama, Junichi Yamaguchi, Yoshifumi Nakajima, Toru Naganuma, Hiroki Bota, Yohei Ohno, Masahiro Yamawaki, Hiroshi Ueno, Kazuki Mizutani, Yuya Adachi, Toshiaki Otsuka, Shunsuke Kubo, Georg Nickenig, Kentaro Hayashida, on behalf of the OCEAN-Mitral Investigators","doi":"10.1161/circinterventions.123.013794","DOIUrl":"https://doi.org/10.1161/circinterventions.123.013794","url":null,"abstract":"BACKGROUND:The extent of cardiac damage and its association with clinical outcomes in patients undergoing transcatheter edge-to-edge repair (TEER) for degenerative mitral regurgitation remains unclear. This study was aimed to investigate cardiac damage in patients with degenerative mitral regurgitation treated with TEER and its association with outcomes.METHODS:We analyzed patients with degenerative mitral regurgitation treated with TEER in the Optimized Catheter Valvular Intervention-Mitral registry, which is a prospective, multicenter observational data collection in Japan. The study subjects were classified according to the extent of cardiac damage at baseline: no extravalvular cardiac damage (stage 0), mild left ventricular or left atrial damage (stage 1), moderate left ventricular or left atrial damage (stage 2), or right heart damage (stage 3). Two-year mortality after TEER was compared using Kaplan-Meier analysis.RESULTS:Out of 579 study participants, 8 (1.4%) were classified as stage 0, 76 (13.1%) as stage 1, 319 (55.1%) as stage 2, and 176 (30.4%) as stage 3. Two-year survival was 100% in stage 0, 89.5% in stage 1, 78.9% in stage 2, and 75.3% in stage 3 (<i>P</i>=0.013). Compared with stage 0 to 1, stage 2 (hazard ratio, 3.34 [95% CI, 1.03–10.81]; <i>P</i>=0.044) and stage 3 (hazard ratio, 4.51 [95% CI, 1.37–14.85]; <i>P</i>=0.013) were associated with increased risk of 2-year mortality after TEER. Significant reductions in heart failure rehospitalization rate and New York Heart Association functional scale were observed following TEER (both, <i>P</i>&lt;0.001), irrespective of the stage of cardiac damage.CONCLUSIONS:Advanced cardiac damage is associated with an increased risk of mortality in patients undergoing TEER for degenerative mitral regurgitation.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: UMIN000023653.","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140616254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Factors Associated With Coronary Angiography Performed Within 6 Months of Randomization to the Conservative Strategy in the ISCHEMIA Trial","authors":"Radosław Pracoń, John A. Spertus, Samuel Broderick, Sripal Bangalore, Frank W. Rockhold, Witold Ruzyllo, Elena Demchenko, Thuraia Nageh, Gabriel Blacher Grossman, Kreton Mavromatis, Cholenahally N. Manjunath, Paola E.P. Smanio, Gregg W. Stone, G.B. John Mancini, William E. Boden, Jonathan D. Newman, Harmony R. Reynolds, Judith S. Hochman, David J. Maron","doi":"10.1161/circinterventions.123.013435","DOIUrl":"https://doi.org/10.1161/circinterventions.123.013435","url":null,"abstract":"BACKGROUND:ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) did not find an overall reduction in cardiovascular events with an initial invasive versus conservative management strategy in chronic coronary disease; however, there were conservative strategy participants who underwent invasive coronary angiography early postrandomization (within 6 months). Identifying factors associated with angiography in conservative strategy participants will inform clinical decision-making in patients with chronic coronary disease.METHODS:Factors independently associated with angiography performed within 6 months of randomization were identified using Fine and Gray proportional subdistribution hazard models, including demographics, region of randomization, medical history, risk factor control, symptoms, ischemia severity, coronary anatomy based on protocol-mandated coronary computed tomography angiography, and medication use.RESULTS:Among 2591 conservative strategy participants, angiography within 6 months of randomization occurred in 8.7% (4.7% for a suspected primary end point event, 1.6% for persistent symptoms, and 2.6% due to protocol nonadherence) and was associated with the following baseline characteristics: enrollment in Europe versus Asia (hazard ratio [HR], 1.81 [95% CI, 1.14–2.86]), daily and weekly versus no angina (HR, 5.97 [95% CI, 2.78–12.86] and 2.63 [95% CI, 1.51–4.58], respectively), poor to fair versus good to excellent health status (HR, 2.02 [95% CI, 1.23–3.32]) assessed with Seattle Angina Questionnaire, and new/more frequent angina prerandomization (HR, 1.80 [95% CI, 1.34–2.40]). Baseline low-density lipoprotein cholesterol &lt;70 mg/dL was associated with a lower risk of angiography (HR, 0.65 [95% CI, 0.46–0.91) but not baseline ischemia severity nor the presence of multivessel or proximal left anterior descending artery stenosis &gt;70% on coronary computed tomography angiography.CONCLUSIONS:Among ISCHEMIA participants randomized to the conservative strategy, angiography within 6 months of randomization was performed in &lt;10% of patients. It was associated with frequent or increasing baseline angina and poor quality of life but not with objective markers of disease severity. Well-controlled baseline low-density lipoprotein cholesterol was associated with a reduced likelihood of angiography. These findings point to the importance of a comprehensive assessment of symptoms and a review of guideline-directed medical therapy goals when deciding the initial treatment strategy for chronic coronary disease.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140616259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}