Pub Date : 2024-05-01Epub Date: 2024-05-21DOI: 10.1161/CIRCINTERVENTIONS.123.013844
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
Background: 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.
Methods: 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.
Results: μFR and QFR analyses were feasible in 443 patients (552 lesions). μFR showed acceptable correlation with FFR (R=0.777; P<0.001), comparable C-index with QFR to predict FFR ≤0.80 (μFR versus QFR: 0.926 versus 0.961, P=0.070), and shorter total analysis time (mean, 32.7 versus 186.9 s; P<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]; P=0.048).
Conclusions: 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.
背景:基于默里定律的定量血流比(μFR)是一种新兴技术,只需冠状动脉造影的一次投影,准确性与定量血流比(QFR)相似。然而,在评估急性心肌梗死(AMI)中的非梗死相关动脉(non-IRA)时,该技术尚未得到验证。因此,我们的研究旨在评估μFR的诊断准确性,以及在AMI情况下推迟μFR>0.80的非IRA病变的安全性。方法:对参加 FRAME-AMI 试验(急性心肌梗死患者非梗死相关动脉狭窄管理的分数血流储备与血管造影引导策略)的 AMI 患者的非 IRA 病变的 μFR 和 QFR 进行分析,该试验包括分数血流储备(FFR)引导的经皮冠状动脉介入治疗组和血管造影引导的经皮冠状动脉介入治疗组。μFR的诊断准确性与QFR和FFR进行了比较。以非 IRA μFR 值 0.80 为临界值对患者进行分类。主要结果是以血管为导向的综合结果,即心源性死亡、非 IRA 相关心肌梗死和非 IRA 相关重复血管再通的综合结果。结果:μFR 和 QFR 分析适用于 443 例患者(552 个病变)。070),总分析时间更短(平均为 32.7 秒对 186.9 秒;P0.80),与进行经皮冠状动脉介入治疗的非 IRA 相比,延迟经皮冠状动脉介入治疗的血管导向复合结局风险显著更低(3.4% 对 10.5%;危险比为 0.37 [95% CI, 0.14-0.99]; P=0.048):在多血管急性心肌梗死患者中,非IRA的μFR在预测FFR≤0.80方面显示出与QFR相当的可接受的诊断准确性。与血管再通的非IRA相比,μFR>0.80的延迟非IRA显示出较低的血管导向复合结局风险:URL:https://www.clinicaltrials.gov;唯一标识符:NCT02715518。
{"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}
Pub Date : 2024-05-01Epub Date: 2024-05-21DOI: 10.1161/CIRCINTERVENTIONS.123.013302
Serge Korjian, Killian J McCarthy, Emily A Larnard, Donald E Cutlip, Margaret B McEntegart, Ajay J Kirtane, Robert W Yeh
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.
{"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}
Pub Date : 2024-04-17DOI: 10.1161/circinterventions.123.013579
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
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]; P=0.023) and MAEs (adjusted hazard ratio, 1.12 [95% CI, 1.06–1.17]; P=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]; P=0.015) and MAEs (hazard ratio, 3.71 [95% CI, 1.71–8.07]; P=0.001), although LAA patency without visible PDL showed higher risks of MAEs (hazard ratio, 3.59 [95% CI, 1.28–10.09]; P=0.015). Incidences of stroke/TIA (2.8% versus 3.0% versus 6.7% versus 22.2%; P=0.010), cardiovascular death (0.9% versus 0% versus 1.7% versus 11.1%; P=0.005), and MAEs (4.6% versus 9.0% versus 11.7% versus 22.2%; P=0.017) increased with larger PDL (0, >0 to ≤3, >3 to ≤5, or >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.
{"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, >0 to ≤3, >3 to ≤5, or >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}
Pub Date : 2024-04-17DOI: 10.1161/circinterventions.123.013156
Johanna Vogelhuber, Tetsu Tanaka, Refik Kavsur, Tadahiro Goto, Can Öztürk, Miriam Silaschi, Georg Nickenig, Sebastian Zimmer, Marcel Weber, Atsushi Sugiura
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 <17 mm and RVFAC <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 (P=0.99). Tricuspid regurgitation reduction to ≤2+ was consistently achieved irrespective of RV dysfunction (76.5% versus 70.5%; P=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; P=0.001; RVFAC, 46.2%±8.1% to 40.3%±9.7%; P<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; P=0.011; RVFAC, 29.6%±4.1% to 31.6%±8.3%; P=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%; P<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.
{"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 <17 mm and RVFAC <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><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><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}
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 (P=0.013). Compared with stage 0 to 1, stage 2 (hazard ratio, 3.34 [95% CI, 1.03–10.81]; P=0.044) and stage 3 (hazard ratio, 4.51 [95% CI, 1.37–14.85]; P=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, P<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.
{"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><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}
Pub Date : 2024-04-17DOI: 10.1161/circinterventions.123.013435
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
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 <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 >70% on coronary computed tomography angiography.CONCLUSIONS:Among ISCHEMIA participants randomized to the conservative strategy, angiography within 6 months of randomization was performed in <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.
{"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 <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 >70% on coronary computed tomography angiography.CONCLUSIONS:Among ISCHEMIA participants randomized to the conservative strategy, angiography within 6 months of randomization was performed in <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}
Pub Date : 2024-04-17DOI: 10.1161/circinterventions.123.013237
Ha Hye Jo, Do-Yoon Kang, Joong Min Lee, So-Min Lim, Young-Sun Park, Yeonwoo Choi, Hoyun Kim, Jinho Lee, Jung-Min Ahn, Duk-Woo Park, Seung-Jung Park
BACKGROUND:The optimal functional evaluation of coronary artery stenosis in patients with severe aortic stenosis (AS) has not been established. The objective of the study was to evaluate the instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) in patients with and without severe AS.METHODS:We retrospectively investigated 395 lesions in 293 patients with severe AS and 2257 lesions in 1882 patients without severe AS between 2010 and 2022 from a subgroup of the Interventional Cardiology Research In-Cooperation Society FFR Registry. All patients had FFR values, and iFR was analyzed post hoc using dedicated software only in lesions with adequate resting pressure curves (311 lesions in patients with severe AS and 2257 lesions in patients with nonsevere AS).RESULTS:The incidence of iFR ≤0.89 was 66.6% and 31.8% (P<0.001), while the incidence of FFR ≤0.80 was 45.3% and 43.9% (P=0.60) in the severe AS group and the nonsevere AS group, respectively. In the severe AS group, most lesions (95.2%) with iFR >0.89 had FFR >0.80, while 36.2% of lesions with iFR ≤0.89 had FFR >0.80. During a median follow-up of 2 years, FFR ≤0.80 was significantly associated with deferred lesion failure (adjusted hazard ratio, 2.71 [95% CI, 1.08–6.80]; P=0.034), while iFR ≤0.89 showed no prognostic value (adjusted hazard ratio, 1.31 [95% CI, 0.47–3.60]; P=0.60) in the severe AS group. Lesions with iFR ≤0.89 and FFR >0.80, in particular, were not associated with a higher rate of deferred lesion failure at 3 years compared with lesions with iFR >0.89 (15.4% versus 17.0%; P=0.58).CONCLUSIONS:This study suggested that FFR appears to be less affected by the presence of severe AS and is more associated with prognosis. iFR may overestimate the functional severity of coronary artery disease without prognostic significance, yet it can be useful for excluding significant stenosis in patients with severe AS.
{"title":"Evaluation of Instantaneous Wave-Free Ratio and Fractional Flow Reserve in Severe Aortic Valve Stenosis","authors":"Ha Hye Jo, Do-Yoon Kang, Joong Min Lee, So-Min Lim, Young-Sun Park, Yeonwoo Choi, Hoyun Kim, Jinho Lee, Jung-Min Ahn, Duk-Woo Park, Seung-Jung Park","doi":"10.1161/circinterventions.123.013237","DOIUrl":"https://doi.org/10.1161/circinterventions.123.013237","url":null,"abstract":"BACKGROUND:The optimal functional evaluation of coronary artery stenosis in patients with severe aortic stenosis (AS) has not been established. The objective of the study was to evaluate the instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) in patients with and without severe AS.METHODS:We retrospectively investigated 395 lesions in 293 patients with severe AS and 2257 lesions in 1882 patients without severe AS between 2010 and 2022 from a subgroup of the Interventional Cardiology Research In-Cooperation Society FFR Registry. All patients had FFR values, and iFR was analyzed post hoc using dedicated software only in lesions with adequate resting pressure curves (311 lesions in patients with severe AS and 2257 lesions in patients with nonsevere AS).RESULTS:The incidence of iFR ≤0.89 was 66.6% and 31.8% (<i>P</i><0.001), while the incidence of FFR ≤0.80 was 45.3% and 43.9% (<i>P</i>=0.60) in the severe AS group and the nonsevere AS group, respectively. In the severe AS group, most lesions (95.2%) with iFR >0.89 had FFR >0.80, while 36.2% of lesions with iFR ≤0.89 had FFR >0.80. During a median follow-up of 2 years, FFR ≤0.80 was significantly associated with deferred lesion failure (adjusted hazard ratio, 2.71 [95% CI, 1.08–6.80]; <i>P</i>=0.034), while iFR ≤0.89 showed no prognostic value (adjusted hazard ratio, 1.31 [95% CI, 0.47–3.60]; <i>P</i>=0.60) in the severe AS group. Lesions with iFR ≤0.89 and FFR >0.80, in particular, were not associated with a higher rate of deferred lesion failure at 3 years compared with lesions with iFR >0.89 (15.4% versus 17.0%; <i>P</i>=0.58).CONCLUSIONS:This study suggested that FFR appears to be less affected by the presence of severe AS and is more associated with prognosis. iFR may overestimate the functional severity of coronary artery disease without prognostic significance, yet it can be useful for excluding significant stenosis in patients with severe AS.","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":"140617486","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}
Pub Date : 2024-04-16DOI: 10.1161/circinterventions.122.013000
Carlos M. Campos, Roxana Mehran, Davide Capodanno, Ruth Owen, Stephan Windecker, Olivier Varenne, Gregg W. Stone, Marco Valgimigli, Ludhmila Abrahão Hajjar, Roberto Kalil Filho, Keith Oldroyd, Marie-Claude Morice, Philip Urban, Alexandre Abizaid
BACKGROUND:Oncological patients with coronary artery disease face an elevated risk of hemorrhagic and ischemic events following percutaneous coronary intervention. Despite medical guidelines recommending minimal dual antiplatelet therapy (DAPT) duration for patients with cancer, dedicated data on abbreviated DAPT in this population is lacking. This study aims to evaluate the occurrence of ischemic and hemorrhagic events in patients with cancer compared with other high-bleeding risk individuals.METHODS:Patient-level data from 4 high-bleeding risk coronary drug-eluting stent studies (ONYX One, LEADERS FREE, LEADERS FREE II, and SENIOR trials) treated with short DAPT were analyzed. The comparison focused on patients with high-bleeding risk with and without cancer, assessing 1-year rates of net adverse clinical events (all-cause death, myocardial infarction, stroke, revascularization, and Bleeding Academic Research Consortium [BARC] types 3 to 5 bleeding) and major adverse clinical events (all-cause death, myocardial infarction, stroke).RESULTS:A total of 5232 patients were included, of whom 574 individuals had cancer, and 4658 were at high-bleeding risk without previous cancer. Despite being younger with fewer risk factors, patients with cancer had higher net adverse clinical event (HR, 1.25; P=0.01) and major adverse clinical event (HR, 1.26; P=0.02), primarily driven by all-cause mortality and major bleeding (BARC 3–5), but not myocardial infarction, stroke, stent thrombosis, or repeat revascularization. Cancer was an independent predictor of net adverse clinical event (P=0.005), major adverse clinical event (P=0.01), and major bleeding (P=0.03).CONCLUSIONS:The present work is the first report on abbreviated DAPT dedicated to patients with cancer. Cancer is a major marker of adverse outcomes and these events had high lethality. Despite short DAPT, patients with cancer experienced higher rates of major bleeding compared with patients without cancer with high-bleeding risk, which occurred mainly after DAPT discontinuation. These findings reinforce the need for a more detailed and individualized stratification of those patients.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03344653, NCT01623180, NCT02843633, NCT0284.
{"title":"Risk Burden of Cancer in Patients Treated With Abbreviated Dual Antiplatelet Therapy After PCI: Analysis of Multicenter Controlled High-Bleeding Risk Trials","authors":"Carlos M. Campos, Roxana Mehran, Davide Capodanno, Ruth Owen, Stephan Windecker, Olivier Varenne, Gregg W. Stone, Marco Valgimigli, Ludhmila Abrahão Hajjar, Roberto Kalil Filho, Keith Oldroyd, Marie-Claude Morice, Philip Urban, Alexandre Abizaid","doi":"10.1161/circinterventions.122.013000","DOIUrl":"https://doi.org/10.1161/circinterventions.122.013000","url":null,"abstract":"BACKGROUND:Oncological patients with coronary artery disease face an elevated risk of hemorrhagic and ischemic events following percutaneous coronary intervention. Despite medical guidelines recommending minimal dual antiplatelet therapy (DAPT) duration for patients with cancer, dedicated data on abbreviated DAPT in this population is lacking. This study aims to evaluate the occurrence of ischemic and hemorrhagic events in patients with cancer compared with other high-bleeding risk individuals.METHODS:Patient-level data from 4 high-bleeding risk coronary drug-eluting stent studies (ONYX One, LEADERS FREE, LEADERS FREE II, and SENIOR trials) treated with short DAPT were analyzed. The comparison focused on patients with high-bleeding risk with and without cancer, assessing 1-year rates of net adverse clinical events (all-cause death, myocardial infarction, stroke, revascularization, and Bleeding Academic Research Consortium [BARC] types 3 to 5 bleeding) and major adverse clinical events (all-cause death, myocardial infarction, stroke).RESULTS:A total of 5232 patients were included, of whom 574 individuals had cancer, and 4658 were at high-bleeding risk without previous cancer. Despite being younger with fewer risk factors, patients with cancer had higher net adverse clinical event (HR, 1.25; <i>P</i>=0.01) and major adverse clinical event (HR, 1.26; <i>P</i>=0.02), primarily driven by all-cause mortality and major bleeding (BARC 3–5), but not myocardial infarction, stroke, stent thrombosis, or repeat revascularization. Cancer was an independent predictor of net adverse clinical event (<i>P</i>=0.005), major adverse clinical event (<i>P</i>=0.01), and major bleeding (<i>P</i>=0.03).CONCLUSIONS:The present work is the first report on abbreviated DAPT dedicated to patients with cancer. Cancer is a major marker of adverse outcomes and these events had high lethality. Despite short DAPT, patients with cancer experienced higher rates of major bleeding compared with patients without cancer with high-bleeding risk, which occurred mainly after DAPT discontinuation. These findings reinforce the need for a more detailed and individualized stratification of those patients.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03344653, NCT01623180, NCT02843633, NCT0284.","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140616168","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}
Pub Date : 2024-04-16DOI: 10.1161/circinterventions.123.013196
Yuanjia Zhu, Shin Yajima, Matthew H. Park, Akshay Venkatesh, Charles J. Stark, Nicholas A. Tran, Sabrina K. Walsh, Sidarth Ethiraj, Robert J. Wilkerson, Luca E. Lin, Seung Hyun Lee, Kate Y. Gates, Justin D. Arthur, Sam W. Baker, Danielle M. Mullis, Catherine A. Wu, Shun Harima, Bipul Pokhrel, Dominique Resuello, Hunter Bergamasco, Matthew A. Wu, Basil M. Baccouche, Pearly K. Pandya, Stefan Elde, Hanjay Wang, Y. Joseph Woo
BACKGROUND:Various mitral repair techniques have been described. Though these repair techniques can be highly effective when performed correctly in suitable patients, limited quantitative biomechanical data are available. Validation and thorough biomechanical evaluation of these repair techniques from translational large animal in vivo studies in a standardized, translatable fashion are lacking. We sought to evaluate and validate biomechanical differences among different mitral repair techniques and further optimize repair operations using a large animal mitral valve prolapse model.METHODS:Male Dorset sheep (n=20) had P2 chordae severed to create the mitral valve prolapse model. Fiber Bragg grating force sensors were implanted to measure chordal forces. Ten sheep underwent 3 randomized, paired mitral valve repair operations: neochord repair, nonresectional leaflet remodeling, and triangular resection. The other 10 sheep underwent neochord repair with 2, 4, and 6 neochordae. Data were collected at baseline, mitral valve prolapse, and after each repair.RESULTS:All mitral repair techniques successfully eliminated regurgitation. Compared with mitral valve prolapse (0.54±0.18 N), repair using neochord (0.37±0.20 N; P=0.02) and remodeling techniques (0.30±0.15 N; P=0.001) reduced secondary chordae peak force. Neochord repair further decreased primary chordae peak force (0.21±0.14 N) to baseline levels (0.20±0.17 N; P=0.83), and was associated with lower primary chordae peak force compared with the remodeling (0.34±0.18 N; P=0.02) and triangular resectional techniques (0.36±0.27 N; P=0.03). Specifically, repair using 2 neochordae resulted in higher peak primary chordal forces (0.28±0.21 N) compared with those using 4 (0.22±0.16 N; P=0.02) or 6 neochordae (0.19±0.16 N; P=0.002). No difference in peak primary chordal forces was observed between 4 and 6 neochordae (P=0.05). Peak forces on the neochordae were the lowest using 6 neochordae (0.09±0.11 N) compared with those of 4 neochordae (0.15±0.14 N; P=0.01) and 2 neochordae (0.29±0.18 N; P=0.001).CONCLUSIONS:Significant biomechanical differences were observed underlying different mitral repair techniques in a translational large animal model. Neochord repair was associated with the lowest primary chordae peak force compared to the remodeling and triangular resectional techniques. Additionally, neochord repair using at least 4 neochordae was associated with lower chordal forces on the primary chordae and the neochordae. This study provided key insights about mitral valve repair optimization and may further improve repair durability.
{"title":"Large Animal Translational Validation of 3 Mitral Valve Repair Operations for Mitral Regurgitation Using a Mitral Valve Prolapse Model: A Comprehensive In Vivo Biomechanical Engineering Analysis","authors":"Yuanjia Zhu, Shin Yajima, Matthew H. Park, Akshay Venkatesh, Charles J. Stark, Nicholas A. Tran, Sabrina K. Walsh, Sidarth Ethiraj, Robert J. Wilkerson, Luca E. Lin, Seung Hyun Lee, Kate Y. Gates, Justin D. Arthur, Sam W. Baker, Danielle M. Mullis, Catherine A. Wu, Shun Harima, Bipul Pokhrel, Dominique Resuello, Hunter Bergamasco, Matthew A. Wu, Basil M. Baccouche, Pearly K. Pandya, Stefan Elde, Hanjay Wang, Y. Joseph Woo","doi":"10.1161/circinterventions.123.013196","DOIUrl":"https://doi.org/10.1161/circinterventions.123.013196","url":null,"abstract":"BACKGROUND:Various mitral repair techniques have been described. Though these repair techniques can be highly effective when performed correctly in suitable patients, limited quantitative biomechanical data are available. Validation and thorough biomechanical evaluation of these repair techniques from translational large animal in vivo studies in a standardized, translatable fashion are lacking. We sought to evaluate and validate biomechanical differences among different mitral repair techniques and further optimize repair operations using a large animal mitral valve prolapse model.METHODS:Male Dorset sheep (n=20) had P2 chordae severed to create the mitral valve prolapse model. Fiber Bragg grating force sensors were implanted to measure chordal forces. Ten sheep underwent 3 randomized, paired mitral valve repair operations: neochord repair, nonresectional leaflet remodeling, and triangular resection. The other 10 sheep underwent neochord repair with 2, 4, and 6 neochordae. Data were collected at baseline, mitral valve prolapse, and after each repair.RESULTS:All mitral repair techniques successfully eliminated regurgitation. Compared with mitral valve prolapse (0.54±0.18 N), repair using neochord (0.37±0.20 N; <i>P</i>=0.02) and remodeling techniques (0.30±0.15 N; <i>P</i>=0.001) reduced secondary chordae peak force. Neochord repair further decreased primary chordae peak force (0.21±0.14 N) to baseline levels (0.20±0.17 N; <i>P</i>=0.83), and was associated with lower primary chordae peak force compared with the remodeling (0.34±0.18 N; <i>P</i>=0.02) and triangular resectional techniques (0.36±0.27 N; <i>P</i>=0.03). Specifically, repair using 2 neochordae resulted in higher peak primary chordal forces (0.28±0.21 N) compared with those using 4 (0.22±0.16 N; <i>P</i>=0.02) or 6 neochordae (0.19±0.16 N; <i>P</i>=0.002). No difference in peak primary chordal forces was observed between 4 and 6 neochordae (<i>P</i>=0.05). Peak forces on the neochordae were the lowest using 6 neochordae (0.09±0.11 N) compared with those of 4 neochordae (0.15±0.14 N; <i>P</i>=0.01) and 2 neochordae (0.29±0.18 N; <i>P</i>=0.001).CONCLUSIONS:Significant biomechanical differences were observed underlying different mitral repair techniques in a translational large animal model. Neochord repair was associated with the lowest primary chordae peak force compared to the remodeling and triangular resectional techniques. Additionally, neochord repair using at least 4 neochordae was associated with lower chordal forces on the primary chordae and the neochordae. This study provided key insights about mitral valve repair optimization and may further improve repair durability.","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140616148","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}
Pub Date : 2024-04-16DOI: 10.1161/circinterventions.123.013675
Giovanni Luigi De Maria, John P. Greenwood, Azfar G. Zaman, Didier Carrié, Pierre Coste, Marco Valgimigli, Miles Behan, Colin Berry, Andrejs Erglis, Vasileios F. Panoulas, Eric Van Belle, Christian Juhl Terkelsen, Lukas Hunziker Munsch, Ajay K. Jain, Jens Flensted Lassen, Nick Palmer, Gregg W. Stone, Adrian P. Banning
BACKGROUND:Primary percutaneous coronary intervention (pPCI) has improved clinical outcomes in patients with ST-segment-elevation myocardial infarction. However, as many as 50% of patients still have suboptimal myocardial reperfusion and experience extensive myocardial necrosis. The PiCSO-AMI-I trial (Pressure-Controlled Intermittent Coronary Sinus Occlusion-Acute Myocardial Infarction-I) evaluated whether PiCSO therapy can further reduce myocardial infarct size (IS) in patients undergoing pPCI.METHODS:Patients with anterior ST-segment–elevation myocardial infarction and Thrombolysis in Myocardial Infarction flow 0-1 were randomized at 16 European centers to PiCSO-assisted pPCI or conventional pPCI. The PiCSO Impulse Catheter (8Fr balloon-tipped catheter) was inserted via femoral venous access after antegrade flow restoration of the culprit vessel and before proceeding with stenting. The primary end point was the difference in IS (expressed as a percentage of left ventricular mass) at 5 days by cardiac magnetic resonance. Secondary end points were the extent of microvascular obstruction and intramyocardial hemorrhage at 5 days and IS at 6 months.RESULTS:Among 145 randomized patients, 72 received PiCSO-assisted pPCI and 73 conventional pPCI. No differences were observed in IS at 5 days (27.2%±12.4% versus 28.3%±11.45%; P=0.59) and 6 months (19.2%±10.1% versus 18.8%±7.7%; P=0.83), nor were differences between PiCSO-treated and control patients noted in terms of the occurrence of microvascular obstruction (67.2% versus 64.6%; P=0.85) or intramyocardial hemorrhage (55.7% versus 60%; P=0.72). The study was prematurely discontinued by the sponsor with no further clinical follow-up beyond 6 months. However, up to 6 months of PiCSO use appeared safe with no device-related adverse events.CONCLUSIONS:In this prematurely discontinued randomized trial, PiCSO therapy as an adjunct to pPCI did not reduce IS when compared with conventional pPCI in patients with anterior ST-segment–elevation myocardial infarction. PiCSO use was associated with increased procedural time and contrast but no increase in adverse events up to 6 months.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03625869.
{"title":"Pressure-Controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction: The PiCSO-AMI-I Trial","authors":"Giovanni Luigi De Maria, John P. Greenwood, Azfar G. Zaman, Didier Carrié, Pierre Coste, Marco Valgimigli, Miles Behan, Colin Berry, Andrejs Erglis, Vasileios F. Panoulas, Eric Van Belle, Christian Juhl Terkelsen, Lukas Hunziker Munsch, Ajay K. Jain, Jens Flensted Lassen, Nick Palmer, Gregg W. Stone, Adrian P. Banning","doi":"10.1161/circinterventions.123.013675","DOIUrl":"https://doi.org/10.1161/circinterventions.123.013675","url":null,"abstract":"BACKGROUND:Primary percutaneous coronary intervention (pPCI) has improved clinical outcomes in patients with ST-segment-elevation myocardial infarction. However, as many as 50% of patients still have suboptimal myocardial reperfusion and experience extensive myocardial necrosis. The PiCSO-AMI-I trial (Pressure-Controlled Intermittent Coronary Sinus Occlusion-Acute Myocardial Infarction-I) evaluated whether PiCSO therapy can further reduce myocardial infarct size (IS) in patients undergoing pPCI.METHODS:Patients with anterior ST-segment–elevation myocardial infarction and Thrombolysis in Myocardial Infarction flow 0-1 were randomized at 16 European centers to PiCSO-assisted pPCI or conventional pPCI. The PiCSO Impulse Catheter (8Fr balloon-tipped catheter) was inserted via femoral venous access after antegrade flow restoration of the culprit vessel and before proceeding with stenting. The primary end point was the difference in IS (expressed as a percentage of left ventricular mass) at 5 days by cardiac magnetic resonance. Secondary end points were the extent of microvascular obstruction and intramyocardial hemorrhage at 5 days and IS at 6 months.RESULTS:Among 145 randomized patients, 72 received PiCSO-assisted pPCI and 73 conventional pPCI. No differences were observed in IS at 5 days (27.2%±12.4% versus 28.3%±11.45%; <i>P</i>=0.59) and 6 months (19.2%±10.1% versus 18.8%±7.7%; <i>P</i>=0.83), nor were differences between PiCSO-treated and control patients noted in terms of the occurrence of microvascular obstruction (67.2% versus 64.6%; <i>P</i>=0.85) or intramyocardial hemorrhage (55.7% versus 60%; <i>P</i>=0.72). The study was prematurely discontinued by the sponsor with no further clinical follow-up beyond 6 months. However, up to 6 months of PiCSO use appeared safe with no device-related adverse events.CONCLUSIONS:In this prematurely discontinued randomized trial, PiCSO therapy as an adjunct to pPCI did not reduce IS when compared with conventional pPCI in patients with anterior ST-segment–elevation myocardial infarction. PiCSO use was associated with increased procedural time and contrast but no increase in adverse events up to 6 months.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03625869.","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140616253","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}