Grigorios Korosoglou MD , Andrej Schmidt MD , Michael Lichtenberg MD , Nasser Malyar MD , Konstantinos Stavroulakis MD , Holger Reinecke MD , Gerd Grözinger MD , Lorenzo Patrone MD , Ramon L. Varcoe MBBS, MS, PhD, MMed (ClinEpi) , Peter A. Soukas MD , Dittmar Böckler MD , Christian-Alexander Behrendt MD , Eric A. Secemsky MD , Thomas Zeller MD , Erwin Blessing MD , Ralf Langhoff MD , Christos Rammos MD
{"title":"Global Algorithm for the Endovascular Treatment of Chronic Femoropopliteal Lesions","authors":"Grigorios Korosoglou MD , Andrej Schmidt MD , Michael Lichtenberg MD , Nasser Malyar MD , Konstantinos Stavroulakis MD , Holger Reinecke MD , Gerd Grözinger MD , Lorenzo Patrone MD , Ramon L. Varcoe MBBS, MS, PhD, MMed (ClinEpi) , Peter A. Soukas MD , Dittmar Böckler MD , Christian-Alexander Behrendt MD , Eric A. Secemsky MD , Thomas Zeller MD , Erwin Blessing MD , Ralf Langhoff MD , Christos Rammos MD","doi":"10.1016/j.jcin.2024.11.038","DOIUrl":"10.1016/j.jcin.2024.11.038","url":null,"abstract":"<div><div>A global treatment algorithm was developed for the endovascular revascularization of femoropopliteal lesions and chronic total occlusions, aiming toward a more standardized approach to endovascular treatment in patients with peripheral artery disease. The following steps are proposed. 1) Evaluation of lesion morphology based on preprocedural imaging by Duplex sonography and intravenous ultrasound for selection of lesion preparation tools. Lesion characteristics are mainly defined by calcification, lesion length, and the presence of total occlusion and in-stent restenosis. 2) Selection of vessel preparation strategies, which encompass plain old balloon angioplasty, atherectomy, thrombectomy, intravascular lithotripsy and specialty balloons, or a combination of the preceding, based on lesion and patient-specific characteristics. In addition, a Delphi consensus was applied for the appropriateness of lesion preparation strategies, depending on lesion anatomy, length, plaque morphology, and subintimal versus intraluminal guidewire crossing. 3) Definitive lesion treatment strategies using drug-coated balloons, bare-metal stents, drug-eluting stents, and/or covered stents or a combination. By establishing this treatment algorithm in routine practice, improvements in vessel- and patient-specific outcomes are anticipated, which will be further enhanced by continuous collaboration among experts from different countries and disciplines and by randomized controlled trials.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 5","pages":"Pages 545-557"},"PeriodicalIF":11.7,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143592371","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":"No Class Effect Among the Second in Class","authors":"Pierfrancesco Agostoni MD, PhD, Enrico Poletti MD","doi":"10.1016/j.jcin.2024.12.012","DOIUrl":"10.1016/j.jcin.2024.12.012","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 5","pages":"Pages 663-665"},"PeriodicalIF":11.7,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364723","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}
Amit N. Vora MD, MPH , Lucy A. Pereira BA , Chengan Du PhD , Zhen Tan MS , Chien Yu Huang PhD , Daniel J. Friedman MD , Yongfei Wang MS , Kamil F. Faridi MD, MSc , Dhanunjaya R. Lakkireddy MD , Sarah Zimmerman MS , Angela Y. Higgins MD , Samir R. Kapadia MD , Jeptha P. Curtis MD , James V. Freeman MD, MPH, MS
{"title":"Association of Physician Certification and Outcomes Among Patients Undergoing Left Atrial Appendage Occlusion","authors":"Amit N. Vora MD, MPH , Lucy A. Pereira BA , Chengan Du PhD , Zhen Tan MS , Chien Yu Huang PhD , Daniel J. Friedman MD , Yongfei Wang MS , Kamil F. Faridi MD, MSc , Dhanunjaya R. Lakkireddy MD , Sarah Zimmerman MS , Angela Y. Higgins MD , Samir R. Kapadia MD , Jeptha P. Curtis MD , James V. Freeman MD, MPH, MS","doi":"10.1016/j.jcin.2024.10.020","DOIUrl":"10.1016/j.jcin.2024.10.020","url":null,"abstract":"<div><h3>Background</h3><div>Percutaneous left atrial appendage occlusion (LAAO) is indicated in patients with atrial fibrillation for whom long-term oral anticoagulation is contraindicated. Whether outcomes are different based on operator certification (interventional cardiology [IC] vs electrophysiology [EP]) is unclear.</div></div><div><h3>Objectives</h3><div>The authors sought to compare LAAO outcomes by physician certification (EP vs IC) in the NCDR (National Cardiovascular Data Registry) LAAO Registry.</div></div><div><h3>Methods</h3><div>We identified patients from 2020 to 2022 undergoing implantation of a Watchman FLX (Boston Scientific) or Amulet (Abbott Cardiovascular) LAAO device and stratified patients by primary operator certification. Outcomes of interest included: 1) any major adverse event (MAE); 2) mortality; 3) ischemic stroke; and 4) major bleeding during the initial hospitalization and at 45 days. We performed multivariable Cox proportional hazards regression analysis to determine the risk of adverse events by physician certification.</div></div><div><h3>Results</h3><div>A total of 1,638 physicians (57% electrophysiologists) performing 91,711 procedures during the study period were included. EPs were more likely to use intracardiac echocardiography (25.2% vs 9.7%; <em>P</em> < 0.001) and had lower radiation total (235 mGy vs 305 mGy; <em>P</em> < 0.001). EPs were more likely than ICs to discharge patients on DOAC + aspirin, whereas ICs were more likely to discharge patients on single or dual antiplatelet therapy (all <em>P</em> < 0.001). In-hospital death (0.1% vs 0.1%; <em>P</em> = 0.46) and MAE (1.5% vs 1.6%; <em>P</em> = 0.42) were similar by physician certification. At 45 days, there was no difference in death (HR<sub>death</sub>: 1.03; 95% CI: 0.89-1.20) or MAE (HR<sub>MAE</sub>: 0.97; 95% CI: 0.91-1.03) after multivariable regression.</div></div><div><h3>Conclusions</h3><div>Contemporary LAAO is safe with low rates of procedural complications and no significant differences in procedural outcomes by operator subspecialty after multivariable adjustment. Continued utilization of technology by EPs and ICs is necessary to allow for broad access to this treatment for eligible patients.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 5","pages":"Pages 591-602"},"PeriodicalIF":11.7,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545511","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}
Robert A. Byrne MB BCh, PhD , Joo-Yong Hahn MD, PhD , Peter O’Kane MD , Manel Sabaté MD , Ralph Toelg MD , Samuel Copt PhD , Sean Fitzgerald MB BCh , Marie-Claude Morice MD , Jasper Trevelyan MD , Darren Mylotte MD , Antonio Fernandez Ortiz MD, PhD , Himanshu Rai PhD , Rory Durand MB BCh , Jochen Wöhrle MD , Franz Xever Kleber MD , Giuilo Stefanini MD , Fernando Alfonso MD, PhD
{"title":"Randomized Trial of Biolimus DCB for In-Stent Restenosis","authors":"Robert A. Byrne MB BCh, PhD , Joo-Yong Hahn MD, PhD , Peter O’Kane MD , Manel Sabaté MD , Ralph Toelg MD , Samuel Copt PhD , Sean Fitzgerald MB BCh , Marie-Claude Morice MD , Jasper Trevelyan MD , Darren Mylotte MD , Antonio Fernandez Ortiz MD, PhD , Himanshu Rai PhD , Rory Durand MB BCh , Jochen Wöhrle MD , Franz Xever Kleber MD , Giuilo Stefanini MD , Fernando Alfonso MD, PhD","doi":"10.1016/j.jcin.2024.11.026","DOIUrl":"10.1016/j.jcin.2024.11.026","url":null,"abstract":"<div><h3>Background</h3><div>In recent years, drug-coated balloon (DCB) angioplasty has become an established treatment option for the treatment of coronary in-stent restenosis (ISR).</div></div><div><h3>Objectives</h3><div>The aim of this study was to compare the angiographic and clinical performance of the Biolimus A9–coated balloon (BCB; Biosensors Europe) with that of the paclitaxel-coated balloon (PCB; SeQuent Please, Braun Melsungen).</div></div><div><h3>Methods</h3><div>REFORM (Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the Biolimus A9™ Drug Coated Balloon for the Treatment of In-Stent Restenosis: First-in-Man Trial) was a multicenter, assessor-blinded, noninferiority, 2:1 randomized controlled trial comparing the BCB and the PCB for the treatment of coronary ISR. The primary endpoint was in-segment percentage diameter stenosis at 6 months. Secondary endpoints included target lesion failure. The trial was registered prospectively at ClinicalTrials.gov (<span><span>NCT04079192</span><svg><path></path></svg></span>).</div></div><div><h3>Results</h3><div>A total of 202 patients were randomized at 20 centers in 6 countries, with 135 in the BCB group and 67 in the PCB group. The mean patient age was 68.5 ± 10 years. At 6 months, in-segment percentage diameter stenosis was 43.3% ± 22.9% in the BCB group compared with 31.4% ± 17.7% in the PCB group (95% CI for the difference: 4.9%-18.8%; prespecified noninferiority margin 12%, noninferiority <em>P</em> = 0.48). At 1 year, target lesion failure was observed in 23.7% of patients in the BCB group vs 17.1% in the PCB group (HR: 1.44; 95% CI: 0.72-2.88; <em>P</em> = 0.28).</div></div><div><h3>Conclusions</h3><div>In patients with ISR, the REFORM study failed to demonstrate noninferiority of the investigational biolimus DCB compared with the standard paclitaxel DCB.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 5","pages":"Pages 654-662"},"PeriodicalIF":11.7,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364698","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}
Takao Sato MD , Mitsuaki Matsumura PhD , Kei Yamamoto MD , Yoichiro Sugizaki MD , Evan Shlofmitz DO , Jeffrey W. Moses MD , Omar K. Khalique MD , Susan V. Thomas MPH , Sarah Malik MD , Ali Dakroub MD , Mandeep Singh BS , Doosup Shin MD , David J. Cohen MD, MSc , Gary S. Mintz MD , Richard A. Shlofmitz MD , Allen Jeremias MD, MSc , Ziad A. Ali MD, DPhil , Akiko Maehara MD
{"title":"A Revised Optical Coherence Tomography–Derived Calcium Score to Predict Stent Underexpansion in Severely Calcified Lesions","authors":"Takao Sato MD , Mitsuaki Matsumura PhD , Kei Yamamoto MD , Yoichiro Sugizaki MD , Evan Shlofmitz DO , Jeffrey W. Moses MD , Omar K. Khalique MD , Susan V. Thomas MPH , Sarah Malik MD , Ali Dakroub MD , Mandeep Singh BS , Doosup Shin MD , David J. Cohen MD, MSc , Gary S. Mintz MD , Richard A. Shlofmitz MD , Allen Jeremias MD, MSc , Ziad A. Ali MD, DPhil , Akiko Maehara MD","doi":"10.1016/j.jcin.2024.12.001","DOIUrl":"10.1016/j.jcin.2024.12.001","url":null,"abstract":"<div><h3>Background</h3><div>Severe calcification is the morphology most strongly associated with stent underexpansion.</div></div><div><h3>Objectives</h3><div>The aim of this study was to revise an optical coherence tomography (OCT)–derived calcium score to predict stent underexpansion in severely calcified lesions (angle >270°) using a point-based system.</div></div><div><h3>Methods</h3><div>A retrospective observational study was conducted in which 250 de novo lesions undergoing OCT-guided stenting, with angiographically visible calcium and optical coherence tomographic maximum superficial calcium angle >270°, not subjected to atherectomy or specialty balloon treatment before stent implantation, were randomly divided into derivation (n = 167) and validation (n = 83) cohorts. The endpoint was stent expansion (minimum stent area/average of reference luminal area) at the maximum calcium deposition site, and stent expansion <70% was considered underexpansion.</div></div><div><h3>Results</h3><div>Stent underexpansion was present in 19.6% of lesions (49 of 250). In the multivariable linear regression model, the morphologic characteristics associated with stent expansion in the derivation cohort were: 1) calcium >270° with a length longer than 3 mm (regression coefficient = −10.3; 95% CI: −17.8 to −2.8; <em>P</em> = 0.007); 2) calcium angle of 360° (regression coefficient = −15.5; 95% CI: −25.2 to −5.8; <em>P</em> = 0.002); and 3) minimum calcium thickness >0.30 mm (regression coefficient = −12.4; 95% CI: −19.1 to −5.6; <em>P</em> = 0.0004). In the validation cohort, the calcium score (range: 0-3) was significantly correlated with stent expansion (regression coefficient = −9.1; 95% CI: −12.6 to −6.1; <em>P</em> < 0.0001).</div></div><div><h3>Conclusions</h3><div>This revised OCT-derived calcium score can serve as a reliable tool for identifying severely calcified lesions at risk for stent underexpansion.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 5","pages":"Pages 622-633"},"PeriodicalIF":11.7,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143592368","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}