Pub Date : 2024-02-01Epub Date: 2024-01-18DOI: 10.1161/CIRCINTERVENTIONS.123.013298
Elliot J Stein, Colin Neill, Sangeeta Nair, J Greg Terry, J Jeffrey Carr, William F Fearon, Sammy Elmariah, Juyong B Kim, Samir Kapadia, Dharam J Kumbhani, Linda Gillam, Brian Whisenant, Nishath Quader, Alan Zajarias, Frederick G Welt, Anthony A Bavry, Megan Coylewright, Robert Piana, Ravinder R Mallugari, Anna Vatterott, Natalie Jackson, Shi Huang, Brian R Lindman
Background: Frailty associates with worse outcomes after transcatheter aortic valve replacement (TAVR). Sarcopenia underlies frailty, but the association between a comprehensive assessment of sarcopenia-muscle mass, strength, and performance-and outcomes after TAVR has not been examined.
Methods: From a multicenter prospective registry of patients with symptomatic severe aortic stenosis undergoing TAVR, 445 who had a preprocedure computed tomography and clinical assessment of frailty were included. Cross-sectional muscle (psoas and paraspinal) areas were measured on computed tomography and indexed to height. Gait speed and handgrip strength were obtained, and patients were dichotomized into fast versus slow; strong versus weak; and normal versus low muscle mass. As measures of body composition, cross-sectional fat (subcutaneous and visceral) was measured and indexed to height.
Results: The frequency of patients who were slow, weak, and had low muscle mass was 56%, 59%, and 42%, respectively. Among the 3 components of sarcopenia, only slower gait speed (muscle performance) was independently associated with increased post-TAVR mortality (adjusted hazard ratio, 1.12 per 0.1 m/s decrease [95% CI, 1.04-1.21]; P=0.004; adjusted hazard ratio, 1.38 per 1 SD decrease [95% CI, 1.11-1.72]; P=0.004). Meeting multiple sarcopenia criteria was not associated with higher mortality risk than fewer. Lower indexed visceral fat area (adjusted hazard ratio, 1.48 per 1 SD decrease [95% CI, 1.15-1.89]; P=0.002) was associated with mortality but indexed subcutaneous fat was not. Death occurred in 169 (38%) patients.
Conclusions: Among patients with symptomatic severe aortic stenosis and comprehensive sarcopenia and body composition phenotyping, gait speed was the only sarcopenia measure associated with post-TAVR mortality. Lower visceral fat was also associated with increased risk pointing to an obesity paradox also observed in other patient populations. These findings reinforce the clinical utility of gait speed as a measure of risk and a potential target for adjunctive interventions alongside TAVR to optimize clinical outcomes.
{"title":"Associations of Sarcopenia and Body Composition Measures With Mortality After Transcatheter Aortic Valve Replacement.","authors":"Elliot J Stein, Colin Neill, Sangeeta Nair, J Greg Terry, J Jeffrey Carr, William F Fearon, Sammy Elmariah, Juyong B Kim, Samir Kapadia, Dharam J Kumbhani, Linda Gillam, Brian Whisenant, Nishath Quader, Alan Zajarias, Frederick G Welt, Anthony A Bavry, Megan Coylewright, Robert Piana, Ravinder R Mallugari, Anna Vatterott, Natalie Jackson, Shi Huang, Brian R Lindman","doi":"10.1161/CIRCINTERVENTIONS.123.013298","DOIUrl":"10.1161/CIRCINTERVENTIONS.123.013298","url":null,"abstract":"<p><strong>Background: </strong>Frailty associates with worse outcomes after transcatheter aortic valve replacement (TAVR). Sarcopenia underlies frailty, but the association between a comprehensive assessment of sarcopenia-muscle mass, strength, and performance-and outcomes after TAVR has not been examined.</p><p><strong>Methods: </strong>From a multicenter prospective registry of patients with symptomatic severe aortic stenosis undergoing TAVR, 445 who had a preprocedure computed tomography and clinical assessment of frailty were included. Cross-sectional muscle (psoas and paraspinal) areas were measured on computed tomography and indexed to height. Gait speed and handgrip strength were obtained, and patients were dichotomized into fast versus slow; strong versus weak; and normal versus low muscle mass. As measures of body composition, cross-sectional fat (subcutaneous and visceral) was measured and indexed to height.</p><p><strong>Results: </strong>The frequency of patients who were slow, weak, and had low muscle mass was 56%, 59%, and 42%, respectively. Among the 3 components of sarcopenia, only slower gait speed (muscle performance) was independently associated with increased post-TAVR mortality (adjusted hazard ratio, 1.12 per 0.1 m/s decrease [95% CI, 1.04-1.21]; <i>P</i>=0.004; adjusted hazard ratio, 1.38 per 1 SD decrease [95% CI, 1.11-1.72]; <i>P</i>=0.004). Meeting multiple sarcopenia criteria was not associated with higher mortality risk than fewer. Lower indexed visceral fat area (adjusted hazard ratio, 1.48 per 1 SD decrease [95% CI, 1.15-1.89]; <i>P</i>=0.002) was associated with mortality but indexed subcutaneous fat was not. Death occurred in 169 (38%) patients.</p><p><strong>Conclusions: </strong>Among patients with symptomatic severe aortic stenosis and comprehensive sarcopenia and body composition phenotyping, gait speed was the only sarcopenia measure associated with post-TAVR mortality. Lower visceral fat was also associated with increased risk pointing to an obesity paradox also observed in other patient populations. These findings reinforce the clinical utility of gait speed as a measure of risk and a potential target for adjunctive interventions alongside TAVR to optimize clinical outcomes.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139485207","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 : 2024-02-01Epub Date: 2024-02-13DOI: 10.1161/CIRCINTERVENTIONS.123.013846
Stephanie S Colello, Paul N Fiorilli, John W Hirshfeld
{"title":"Old Dogs Can Learn New Tricks: Reducing Radiation Exposure in the Cardiac Catheterization Laboratory.","authors":"Stephanie S Colello, Paul N Fiorilli, John W Hirshfeld","doi":"10.1161/CIRCINTERVENTIONS.123.013846","DOIUrl":"10.1161/CIRCINTERVENTIONS.123.013846","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139721861","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: A high permanent pacemaker implantation (PPI) risk remains a concern of self-expandable transcatheter aortic valve implantation, despite the continued improvements in implantation methodology. We aimed to assess the impact of real-time direct visualization of the membranous septum using transjugular intracardiac echocardiography (ICE) during transcatheter aortic valve implantation on reducing the rates of conduction disturbances including the need for PPI.
Methods: Consecutive patients treated with Evolut R and Evolut PRO/PRO+ from February 2017 to September 2022 were included in this study. We compared outcomes between the conventional implantation method using the 3-cusps view (3 cusps without ICE group), the recent method using cusp-overlap view (cusp overlap without ICE group), and our novel method using ICE (cusp overlap with ICE group).
Results: Of the 446 patients eligible for analysis, 211 (47.3%) were categorized as the 3 cusps without ICE group, 129 (28.9%) were in the cusp overlap without ICE group, and 106 (23.8%) comprised the cusp overlap with ICE group. Compared with the 3 cusps without ICE group, the cusp overlap without ICE group had a smaller implantation depth (2.2 [interquartile range, 1.0-3.5] mm versus 4.3 [interquartile range, 3.3-5.4] mm; P<0.001) and lower 30-day PPI rates (7.0% versus 14.2%; P=0.035). Compared with the cusp overlap without ICE group, the cusp overlap with ICE group had lower 30-day PPI rates (0.9%; P=0.014), albeit with comparable implantation depths (1.9 [interquartile range, 0.9-2.9] mm; P=0.150). Multivariable analysis showed that our novel method using ICE with the cusp-overlap view was independently associated with a 30-day PPI rate reduction. There were no group differences in 30-day all-cause mortality (1.4% versus 1.6% versus 0%; P=0.608).
Conclusions: Our novel implantation method using transjugular ICE, which enable real-time direct visualization of the membranous septum, achieved a predictably high position of prostheses, resulting in a substantial reduction of conduction disturbances requiring PPI after transcatheter aortic valve implantation.
{"title":"Impact of Transjugular Intracardiac Echocardiography-Guided Self-Expandable Transcatheter Aortic Valve Implantation on Reduction of Conduction Disturbances.","authors":"Kenichi Ishizu, Shinichi Shirai, Norihisa Miyawaki, Kenji Nakano, Tadatomo Fukushima, Euihong Ko, Yasuo Tsuru, Hiroaki Tashiro, Hiroyuki Tabata, Miho Nakamura, Toru Morofuji, Takashi Morinaga, Masaomi Hayashi, Akihiro Isotani, Nobuhisa Ohno, Shinichi Kakumoto, Kenji Ando","doi":"10.1161/CIRCINTERVENTIONS.123.013094","DOIUrl":"10.1161/CIRCINTERVENTIONS.123.013094","url":null,"abstract":"<p><strong>Background: </strong>A high permanent pacemaker implantation (PPI) risk remains a concern of self-expandable transcatheter aortic valve implantation, despite the continued improvements in implantation methodology. We aimed to assess the impact of real-time direct visualization of the membranous septum using transjugular intracardiac echocardiography (ICE) during transcatheter aortic valve implantation on reducing the rates of conduction disturbances including the need for PPI.</p><p><strong>Methods: </strong>Consecutive patients treated with Evolut R and Evolut PRO/PRO+ from February 2017 to September 2022 were included in this study. We compared outcomes between the conventional implantation method using the 3-cusps view (3 cusps without ICE group), the recent method using cusp-overlap view (cusp overlap without ICE group), and our novel method using ICE (cusp overlap with ICE group).</p><p><strong>Results: </strong>Of the 446 patients eligible for analysis, 211 (47.3%) were categorized as the 3 cusps without ICE group, 129 (28.9%) were in the cusp overlap without ICE group, and 106 (23.8%) comprised the cusp overlap with ICE group. Compared with the 3 cusps without ICE group, the cusp overlap without ICE group had a smaller implantation depth (2.2 [interquartile range, 1.0-3.5] mm versus 4.3 [interquartile range, 3.3-5.4] mm; <i>P</i><0.001) and lower 30-day PPI rates (7.0% versus 14.2%; <i>P</i>=0.035). Compared with the cusp overlap without ICE group, the cusp overlap with ICE group had lower 30-day PPI rates (0.9%; <i>P</i>=0.014), albeit with comparable implantation depths (1.9 [interquartile range, 0.9-2.9] mm; <i>P</i>=0.150). Multivariable analysis showed that our novel method using ICE with the cusp-overlap view was independently associated with a 30-day PPI rate reduction. There were no group differences in 30-day all-cause mortality (1.4% versus 1.6% versus 0%; <i>P</i>=0.608).</p><p><strong>Conclusions: </strong>Our novel implantation method using transjugular ICE, which enable real-time direct visualization of the membranous septum, achieved a predictably high position of prostheses, resulting in a substantial reduction of conduction disturbances requiring PPI after transcatheter aortic valve implantation.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139048424","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 : 2024-02-01Epub Date: 2024-01-23DOI: 10.1161/CIRCINTERVENTIONS.123.013455
Pengsheng Chen, John W Eikelboom, Chunyue Tan, Wenhao Zhang, Yi Xu, Jianling Bai, Jun Wang, Tong Wang, Xiaoxuan Gong, Kun Liu, Xin Chen, Xiaoyan Wang, Li Zhu, Xin Zhao, Naiquan Yang, Jun Jiang, Jun Pu, Bo Zhao, Zengguang Chen, Baihong Li, Guoyu Wang, Chuan Lu, Lianghong Ying, Meng Jiang, Xiaomei Zhu, Jiazheng Ma, Zhou Dong, Chen Li, Jiaxin Zong, Fumin Zhang, Jun Zhu, Jun Huang, Xiangqing Kong, Hao Yu, Chunjian Li
Background: It is uncertain whether adjunctive thrombolysis is beneficial for patients with ST-segment-elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) within 120 minutes of presentation. This study was to determine whether in patients presenting with ST-segment-elevation myocardial infarction a single bolus recombinant staphylokinase (r-SAK) before timely PCI leads to improved patency of the infarct-related artery and reduces the infarct size.
Methods: This is an open-label, prospective, multicenter, randomized study. We enrolled patients aged 18 to 75 years who were within 12 hours of symptom onset of ST-segment-elevation myocardial infarction and expected to undergo PCI within 120 minutes. Patients were administered loading doses of aspirin and ticagrelor and intravenous heparin and were randomized to receive 5 mg bolus of r-SAK or normal saline intravenously before PCI. The primary end point was Thrombolysis in Myocardial Infarction flow grade 2 to 3 or grade 3 in the infarct-related artery 60 minutes after thrombolysis. The infarct size was detected by cardiac magnetic resonance 5 days after randomization. The safety end point was major bleeding (Bleeding Academic Research Consortium ≥3) during 30-day follow-up.
Results: A total of 283 patients were screened from 8 centers and 200 were randomized (median age, 58.5 years; 14% female). The median symptom to thrombolysis time was 252.5 (interquartile range, 142.8-423.8) minutes and thrombolysis to coronary arteriography was 50.0 (interquartile range, 37.0-66.0) minutes. Patients randomized to r-SAK compared with normal saline more often had Thrombolysis in Myocardial Infarction flow grade 2 to 3 (69.0% versus 29.0%; P<0.001) and Thrombolysis in Myocardial Infarction flow grade 3 (51.0% versus 18.0%; P<0.001) and had smaller infarct size (21.91±10.84% versus 26.85±12.37%; P=0.016). There was no increase in major bleeding (r-SAK, 1.0% versus control, 3.0%; P=0.616).
Conclusions: A single bolus r-SAK before primary PCI for ST-segment-elevation myocardial infarction improves infarct-related artery patency and reduces infarct size without increasing major bleeding.
{"title":"Single Bolus r-SAK Before Primary PCI for ST-Segment-Elevation Myocardial Infarction.","authors":"Pengsheng Chen, John W Eikelboom, Chunyue Tan, Wenhao Zhang, Yi Xu, Jianling Bai, Jun Wang, Tong Wang, Xiaoxuan Gong, Kun Liu, Xin Chen, Xiaoyan Wang, Li Zhu, Xin Zhao, Naiquan Yang, Jun Jiang, Jun Pu, Bo Zhao, Zengguang Chen, Baihong Li, Guoyu Wang, Chuan Lu, Lianghong Ying, Meng Jiang, Xiaomei Zhu, Jiazheng Ma, Zhou Dong, Chen Li, Jiaxin Zong, Fumin Zhang, Jun Zhu, Jun Huang, Xiangqing Kong, Hao Yu, Chunjian Li","doi":"10.1161/CIRCINTERVENTIONS.123.013455","DOIUrl":"10.1161/CIRCINTERVENTIONS.123.013455","url":null,"abstract":"<p><strong>Background: </strong>It is uncertain whether adjunctive thrombolysis is beneficial for patients with ST-segment-elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) within 120 minutes of presentation. This study was to determine whether in patients presenting with ST-segment-elevation myocardial infarction a single bolus recombinant staphylokinase (r-SAK) before timely PCI leads to improved patency of the infarct-related artery and reduces the infarct size.</p><p><strong>Methods: </strong>This is an open-label, prospective, multicenter, randomized study. We enrolled patients aged 18 to 75 years who were within 12 hours of symptom onset of ST-segment-elevation myocardial infarction and expected to undergo PCI within 120 minutes. Patients were administered loading doses of aspirin and ticagrelor and intravenous heparin and were randomized to receive 5 mg bolus of r-SAK or normal saline intravenously before PCI. The primary end point was Thrombolysis in Myocardial Infarction flow grade 2 to 3 or grade 3 in the infarct-related artery 60 minutes after thrombolysis. The infarct size was detected by cardiac magnetic resonance 5 days after randomization. The safety end point was major bleeding (Bleeding Academic Research Consortium ≥3) during 30-day follow-up.</p><p><strong>Results: </strong>A total of 283 patients were screened from 8 centers and 200 were randomized (median age, 58.5 years; 14% female). The median symptom to thrombolysis time was 252.5 (interquartile range, 142.8-423.8) minutes and thrombolysis to coronary arteriography was 50.0 (interquartile range, 37.0-66.0) minutes. Patients randomized to r-SAK compared with normal saline more often had Thrombolysis in Myocardial Infarction flow grade 2 to 3 (69.0% versus 29.0%; <i>P</i><0.001) and Thrombolysis in Myocardial Infarction flow grade 3 (51.0% versus 18.0%; <i>P</i><0.001) and had smaller infarct size (21.91±10.84% versus 26.85±12.37%; <i>P</i>=0.016). There was no increase in major bleeding (r-SAK, 1.0% versus control, 3.0%; <i>P</i>=0.616).</p><p><strong>Conclusions: </strong>A single bolus r-SAK before primary PCI for ST-segment-elevation myocardial infarction improves infarct-related artery patency and reduces infarct size without increasing major bleeding.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT05023681.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139519433","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 : 2024-02-01Epub Date: 2024-02-13DOI: 10.1161/CIRCINTERVENTIONS.123.013847
Jennifer A Rymer, J Antonio Gutierrez
{"title":"Drug-Coated Balloons With or Without Provisional Bare Metal Stenting in Femoropopliteal Disease: No Metal Left Behind?","authors":"Jennifer A Rymer, J Antonio Gutierrez","doi":"10.1161/CIRCINTERVENTIONS.123.013847","DOIUrl":"10.1161/CIRCINTERVENTIONS.123.013847","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139721859","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 : 2024-02-01Epub Date: 2024-02-13DOI: 10.1161/CIRCINTERVENTIONS.123.013084
Gary M Ansel, Marianne Brodmann, Krishna J Rocha-Singh, Jeremiah S Menk, Thomas Zeller
Background: The treatment of complex infra-inguinal disease with drug-coated balloons (DCBs) is associated with a significant number of patients undergoing provisional stenting to treat a suboptimal result. To determine the potential long-term impact of DCB treatment with provisional bare metal stenting in complex lesions in real-world patients, a post hoc analysis was performed on data from the IN.PACT Global Study (The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral Drug-Eluting Balloon). Five-year outcomes were compared between participants who were stented after DCB treatment versus those treated with DCB alone.
Methods: The IN.PACT Global Study enrolled 1535 participants with intermittent claudication and/or ischemic rest pain caused by femoropopliteal lesions; 1397 patients were included in this subgroup analysis (353 stented and 1044 nonstented). Effectiveness was assessed as freedom from clinically driven target lesion revascularization through 60 months. The primary safety composite end point was defined as freedom from device- and procedure-related death through 30 days, and freedom from major target limb amputation and clinically driven target vessel revascularization through 60 months.
Results: Lesions in the stented group were longer (15.37 versus 10.98 cm; P<0.001) and had more total occlusions (54.7% versus 28.6%; P<0.001) compared with the nonstented group. The 5-year Kaplan-Meier estimated freedom from clinically driven target lesion revascularization was similar between groups (66.8% stented versus 70.0% nonstented group, log-rank P=0.22). The safety composite end point was achieved in 64.5% stented versus 68.2% nonstented participants (log-rank P=0.19) as estimated by the Kaplan-Meier method. No significant difference was observed in the cumulative incidence of major adverse events (49.1% stented versus 45.0% nonstented; log-rank P=0.17), including all-cause death (19.6% stented versus 19.3% nonstented, log-rank P=0.99).
Conclusions: In this real-world study, revascularization of complex femoropopliteal artery lesions with DCB angioplasty alone or DCB followed by provisional bare metal stenting in certain lesions achieved comparable long-term safety and clinical effectiveness.
{"title":"Five-Year Safety and Effectiveness of Paclitaxel Drug-Coated Balloons Alone or With Provisional Bare Metal Stenting for Real-World Femoropopliteal Lesions: IN.PACT Global Study Subgroup Analysis.","authors":"Gary M Ansel, Marianne Brodmann, Krishna J Rocha-Singh, Jeremiah S Menk, Thomas Zeller","doi":"10.1161/CIRCINTERVENTIONS.123.013084","DOIUrl":"10.1161/CIRCINTERVENTIONS.123.013084","url":null,"abstract":"<p><strong>Background: </strong>The treatment of complex infra-inguinal disease with drug-coated balloons (DCBs) is associated with a significant number of patients undergoing provisional stenting to treat a suboptimal result. To determine the potential long-term impact of DCB treatment with provisional bare metal stenting in complex lesions in real-world patients, a post hoc analysis was performed on data from the IN.PACT Global Study (The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral Drug-Eluting Balloon). Five-year outcomes were compared between participants who were stented after DCB treatment versus those treated with DCB alone.</p><p><strong>Methods: </strong>The IN.PACT Global Study enrolled 1535 participants with intermittent claudication and/or ischemic rest pain caused by femoropopliteal lesions; 1397 patients were included in this subgroup analysis (353 stented and 1044 nonstented). Effectiveness was assessed as freedom from clinically driven target lesion revascularization through 60 months. The primary safety composite end point was defined as freedom from device- and procedure-related death through 30 days, and freedom from major target limb amputation and clinically driven target vessel revascularization through 60 months.</p><p><strong>Results: </strong>Lesions in the stented group were longer (15.37 versus 10.98 cm; <i>P</i><0.001) and had more total occlusions (54.7% versus 28.6%; <i>P</i><0.001) compared with the nonstented group. The 5-year Kaplan-Meier estimated freedom from clinically driven target lesion revascularization was similar between groups (66.8% stented versus 70.0% nonstented group, log-rank <i>P</i>=0.22). The safety composite end point was achieved in 64.5% stented versus 68.2% nonstented participants (log-rank <i>P</i>=0.19) as estimated by the Kaplan-Meier method. No significant difference was observed in the cumulative incidence of major adverse events (49.1% stented versus 45.0% nonstented; log-rank <i>P</i>=0.17), including all-cause death (19.6% stented versus 19.3% nonstented, log-rank <i>P</i>=0.99).</p><p><strong>Conclusions: </strong>In this real-world study, revascularization of complex femoropopliteal artery lesions with DCB angioplasty alone or DCB followed by provisional bare metal stenting in certain lesions achieved comparable long-term safety and clinical effectiveness.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT01609296.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10871603/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139721860","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}
Pub Date : 2024-02-01Epub Date: 2024-02-13DOI: 10.1161/CIRCINTERVENTIONS.123.013502
Ryan D Madder, Milan Seth, Kathleen Frazier, Simon Dixon, Milind Karve, John Collins, Ronald V Miller, Elizabeth Pielsticker, Manoj Sharma, Devraj Sukul, Hitinder S Gurm
Background: Improved radiation safety practices are needed across hospitals performing percutaneous coronary intervention (PCI). This study was performed to assess the temporal trend in PCI radiation doses concurrent with the conduct of a statewide radiation safety initiative.
Methods: A statewide initiative to reduce PCI radiation doses was conducted in Michigan between 2017 and 2021 and included focused radiation safety education, reporting of institutional radiation doses, and implementation of radiation performance metrics for hospitals. Using data from a large statewide registry, PCI discharges between July 1, 2016, and July 1, 2022, having a procedural air kerma (AK) recorded were analyzed for temporal trends. A multivariable regression analysis was performed to determine whether declines in procedural AK over time were attributable to changes in known predictors of radiation doses.
Results: Among 131 619 PCI procedures performed during the study period, a reduction in procedural AK was observed over time, from a median dose of 1.46 (0.86-2.37) Gy in the first year of the study to 0.97 (0.56-1.64) Gy in the last year of the study (P<0.001). The proportion of cases with an AK ≥5 Gy declined from 4.24% to 0.86% over the same time period (P<0.0001). After adjusting for variables known to impact radiation doses, a 1-year increase in the date of PCI was associated with a 7.61% (95% CI, 7.38%-7.84%) reduction in procedural AK (P<0.0001).
Conclusions: Concurrent with the conduct of a statewide initiative to reduce procedural radiation doses, a progressive and significant decline in procedural radiation doses was observed among patients undergoing PCI in the state of Michigan.
{"title":"Statewide Initiative to Reduce Patient Radiation Doses During Percutaneous Coronary Intervention.","authors":"Ryan D Madder, Milan Seth, Kathleen Frazier, Simon Dixon, Milind Karve, John Collins, Ronald V Miller, Elizabeth Pielsticker, Manoj Sharma, Devraj Sukul, Hitinder S Gurm","doi":"10.1161/CIRCINTERVENTIONS.123.013502","DOIUrl":"10.1161/CIRCINTERVENTIONS.123.013502","url":null,"abstract":"<p><strong>Background: </strong>Improved radiation safety practices are needed across hospitals performing percutaneous coronary intervention (PCI). This study was performed to assess the temporal trend in PCI radiation doses concurrent with the conduct of a statewide radiation safety initiative.</p><p><strong>Methods: </strong>A statewide initiative to reduce PCI radiation doses was conducted in Michigan between 2017 and 2021 and included focused radiation safety education, reporting of institutional radiation doses, and implementation of radiation performance metrics for hospitals. Using data from a large statewide registry, PCI discharges between July 1, 2016, and July 1, 2022, having a procedural air kerma (AK) recorded were analyzed for temporal trends. A multivariable regression analysis was performed to determine whether declines in procedural AK over time were attributable to changes in known predictors of radiation doses.</p><p><strong>Results: </strong>Among 131 619 PCI procedures performed during the study period, a reduction in procedural AK was observed over time, from a median dose of 1.46 (0.86-2.37) Gy in the first year of the study to 0.97 (0.56-1.64) Gy in the last year of the study (<i>P</i><0.001). The proportion of cases with an AK ≥5 Gy declined from 4.24% to 0.86% over the same time period (<i>P</i><0.0001). After adjusting for variables known to impact radiation doses, a 1-year increase in the date of PCI was associated with a 7.61% (95% CI, 7.38%-7.84%) reduction in procedural AK (<i>P</i><0.0001).</p><p><strong>Conclusions: </strong>Concurrent with the conduct of a statewide initiative to reduce procedural radiation doses, a progressive and significant decline in procedural radiation doses was observed among patients undergoing PCI in the state of Michigan.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139721862","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 : 2024-02-01Epub Date: 2024-01-31DOI: 10.1161/CIRCINTERVENTIONS.123.013848
Eugene Yuriditsky, James M Horowitz
{"title":"Prioritizing Rapid Reperfusion in ST-Segment-Elevation Myocardial Infarction Complicated by Cardiogenic Shock: Leveraging Regionalized Systems of Care.","authors":"Eugene Yuriditsky, James M Horowitz","doi":"10.1161/CIRCINTERVENTIONS.123.013848","DOIUrl":"10.1161/CIRCINTERVENTIONS.123.013848","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139641736","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 : 2024-02-01Epub Date: 2024-01-31DOI: 10.1161/CIRCINTERVENTIONS.123.013415
Sean van Diepen, Yinggan Zheng, Janek M Senaratne, Benjamin D Tyrrell, Debraj Das, Holger Thiele, Timothy D Henry, Kevin R Bainey, Robert C Welsh
Background: In patients with ST-segment-elevation myocardial infarction complicated by cardiogenic shock, primary percutaneous coronary intervention (pPCI) is the preferred revascularization option. Little is known about the efficacy and safety of a pharmacoinvasive approach for patients with cardiogenic shock presenting to a non-PCI hospital with prolonged interhospital transport times.
Methods: In a retrospective analysis of geographically extensive ST-segment-elevation myocardial infarction network (2006-2021), 426 patients with cardiogenic shock and ST-segment-elevation myocardial infarction presented to a non-PCI-capable hospital and underwent reperfusion therapy (53.8% pharmacoinvasive and 46.2% pPCI). The primary clinical outcome was a composite of in-hospital mortality, renal failure requiring dialysis, cardiac arrest, or mechanical circulatory support, and the primary safety outcome was major bleeding defined as an intracranial hemorrhage or bleeding that required transfusion was compared in an inverse probability weighted model. The electrocardiographic reperfusion outcome of interest was the worst residual ST-segment-elevation.
Results: Patients with pharmacoinvasive treatment had longer median interhospital transport (3 hours versus 1 hour) and shorter median symptom-onset-to-reperfusion (125 minute-to-needle versus 419 minute-to-balloon) times. ST-segment resolution ≥50% on the postfibrinolysis ECG was 56.6%. Postcatheterization, worst lead residual ST-segment-elevation <1 mm (57.3% versus 46.3%; P=0.01) was higher in the pharmacoinvasive compared with the pPCI cohort, but no differences were observed in the worst lead ST-segment-elevation resolution ≥50% (77.4% versus 81.8%; P=0.57). The primary clinical end point was lower in the pharmacoinvasive cohort (35.2% versus 57.0%; inverse probability weighted odds ratio, 0.44 [95% CI, 0.26-0.72]; P<0.01) compared with patients who received pPCI. An interaction between interhospital transfer time and reperfusion strategy with all-cause mortality was observed, favoring a pharmacoinvasive approach with transfer times >60 minutes. The incidence of the primary safety outcome was 10.1% in the pharmacoinvasive arm versus 18.7% in pPCI (adjusted odds ratio, 0.41 [95% CI, 0.14-1.09]; P=0.08).
Conclusions: In patients with ST-segment-elevation myocardial infarction presenting with cardiogenic shock and prolonged interhospital transport times, a pharmacoinvasive approach was associated with improved electrocardiographic reperfusion and a lower rate of death, dialysis, or mechanical circulatory support without an increase in major bleeding.
背景:对于ST段抬高心肌梗死并发心源性休克的患者,首选的血管重建方案是经皮冠状动脉介入治疗(pPCI)。对于在医院间转运时间较长的非冠状动脉介入治疗医院就诊的心源性休克患者,人们对药物介入治疗的有效性和安全性知之甚少:在一项对地域广泛的ST段抬高型心肌梗死网络(2006-2021年)的回顾性分析中,426名心源性休克和ST段抬高型心肌梗死患者前往不具备PCI能力的医院,并接受了再灌注治疗(53.8%为药物介入治疗,46.2%为pPCI治疗)。主要临床结局是院内死亡率、需要透析的肾功能衰竭、心脏骤停或机械循环支持的综合结果,而主要安全性结局是大出血,定义为颅内出血或需要输血的出血。心电图再灌注的主要结果是最严重的残余ST段抬高:结果:接受药物介入治疗的患者的院间转运中位时间更长(3小时对1小时),从症状出现到再灌注的中位时间更短(125分钟到针头对419分钟到气球)。纤溶后心电图ST段≥50%的患者占56.6%。与 pPCI 队列相比,药物介入治疗后最差导联残余 ST 段抬高率(P=0.01)更高,但在最差导联 ST 段抬高缓解率≥50% 方面未观察到差异(77.4% 对 81.8%;P=0.57)。药物介入治疗队列的主要临床终点较低(35.2% 对 57.0%;反概率加权几率比为 0.44 [95% CI, 0.26-0.72]; P60 分钟)。药物介入治疗组的主要安全结果发生率为 10.1%,而 pPCI 为 18.7%(调整后的几率比为 0.41 [95% CI,0.14-1.09];P=0.08):结论:对于出现心源性休克和院间转运时间延长的 ST 段抬高型心肌梗死患者,无创药物治疗可改善心电图再灌注,降低死亡、透析或机械循环支持的发生率,同时不会增加大出血。
{"title":"Reperfusion in Patients With ST-Segment-Elevation Myocardial Infarction With Cardiogenic Shock and Prolonged Interhospital Transport Times.","authors":"Sean van Diepen, Yinggan Zheng, Janek M Senaratne, Benjamin D Tyrrell, Debraj Das, Holger Thiele, Timothy D Henry, Kevin R Bainey, Robert C Welsh","doi":"10.1161/CIRCINTERVENTIONS.123.013415","DOIUrl":"10.1161/CIRCINTERVENTIONS.123.013415","url":null,"abstract":"<p><strong>Background: </strong>In patients with ST-segment-elevation myocardial infarction complicated by cardiogenic shock, primary percutaneous coronary intervention (pPCI) is the preferred revascularization option. Little is known about the efficacy and safety of a pharmacoinvasive approach for patients with cardiogenic shock presenting to a non-PCI hospital with prolonged interhospital transport times.</p><p><strong>Methods: </strong>In a retrospective analysis of geographically extensive ST-segment-elevation myocardial infarction network (2006-2021), 426 patients with cardiogenic shock and ST-segment-elevation myocardial infarction presented to a non-PCI-capable hospital and underwent reperfusion therapy (53.8% pharmacoinvasive and 46.2% pPCI). The primary clinical outcome was a composite of in-hospital mortality, renal failure requiring dialysis, cardiac arrest, or mechanical circulatory support, and the primary safety outcome was major bleeding defined as an intracranial hemorrhage or bleeding that required transfusion was compared in an inverse probability weighted model. The electrocardiographic reperfusion outcome of interest was the worst residual ST-segment-elevation.</p><p><strong>Results: </strong>Patients with pharmacoinvasive treatment had longer median interhospital transport (3 hours versus 1 hour) and shorter median symptom-onset-to-reperfusion (125 minute-to-needle versus 419 minute-to-balloon) times. ST-segment resolution ≥50% on the postfibrinolysis ECG was 56.6%. Postcatheterization, worst lead residual ST-segment-elevation <1 mm (57.3% versus 46.3%; <i>P</i>=0.01) was higher in the pharmacoinvasive compared with the pPCI cohort, but no differences were observed in the worst lead ST-segment-elevation resolution ≥50% (77.4% versus 81.8%; <i>P</i>=0.57). The primary clinical end point was lower in the pharmacoinvasive cohort (35.2% versus 57.0%; inverse probability weighted odds ratio, 0.44 [95% CI, 0.26-0.72]; <i>P</i><0.01) compared with patients who received pPCI. An interaction between interhospital transfer time and reperfusion strategy with all-cause mortality was observed, favoring a pharmacoinvasive approach with transfer times >60 minutes. The incidence of the primary safety outcome was 10.1% in the pharmacoinvasive arm versus 18.7% in pPCI (adjusted odds ratio, 0.41 [95% CI, 0.14-1.09]; <i>P</i>=0.08).</p><p><strong>Conclusions: </strong>In patients with ST-segment-elevation myocardial infarction presenting with cardiogenic shock and prolonged interhospital transport times, a pharmacoinvasive approach was associated with improved electrocardiographic reperfusion and a lower rate of death, dialysis, or mechanical circulatory support without an increase in major bleeding.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139641737","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 : 2024-02-01Epub Date: 2024-01-18DOI: 10.1161/CIRCINTERVENTIONS.123.013424
Alon Shechter, Mirae Lee, Danon Kaewkes, Vivek Patel, Ofir Koren, Tarun Chakravarty, Keita Koseki, Takashi Nagasaka, Sabah Skaf, Moody Makar, Raj R Makkar, Robert J Siegel
Background: Limited data exist regarding the impact of mitral annular calcification (MAC) on outcomes of transcatheter edge-to-edge repair for mitral regurgitation (MR).
Methods: We retrospectively analyzed 968 individuals (median age, 79 [interquartile range, 70-86] years; 60.0% males; 51.8% with functional MR) who underwent an isolated, first-time intervention. Stratified by MAC extent per baseline transthoracic echocardiogram, the cohort was assessed for residual MR, functional status, all-cause mortality, heart failure hospitalizations, and mitral reinterventions post-procedure.
Results: Patients with above-mild MAC (n=101; 10.4%) were older and more likely to be female, exhibited a greater burden of comorbidities, and presented more often with severe, primary MR. Procedural aspects and technical success rate were unaffected by MAC magnitude, as was the significant improvement from baseline in MR severity and functional status along the first postprocedural year. However, the persistence of above-moderate MR or functional classes III and IV at 1 year and the cumulative incidence of reinterventions at 2 years were overall more pronounced within the above-mild MAC group (significant MR or functional impairment, 44.7% versus 29.9%, P=0.060; reinterventions, 11.9% versus 6.2%, P=0.033; log-rank P=0.035). No link was demonstrated between MAC degree and the cumulative incidence or risk of mortality and mortality or heart failure hospitalizations. Differences in outcomes frequencies were mostly confined to the primary MR subgroup, in which patients with above-mild MAC also experienced earlier, more frequent 2-year heart failure hospitalizations (20.8% versus 9.6%; P=0.016; log-rank P=0.020).
Conclusions: Mitral transcatheter edge-to-edge repair in patients with and without above-mild MAC is equally feasible and safe; however, its postprocedural course is less favorable among those with primary MR.
背景:关于二尖瓣环钙化(MAC)对二尖瓣反流(MR)经导管边缘到边缘修复术疗效影响的数据有限:关于二尖瓣环钙化(MAC)对二尖瓣反流(MR)经导管边缘到边缘修补术结果影响的数据有限:我们回顾性分析了968名首次接受孤立介入治疗的患者(中位年龄79岁[四分位间范围70-86岁];60.0%为男性;51.8%患有功能性二尖瓣反流)。根据基线经胸超声心动图的 MAC 程度进行分层,对队列中的残余 MR、功能状态、全因死亡率、心力衰竭住院率和二尖瓣术后再介入情况进行评估:轻度以上二尖瓣置换术患者(n=101;10.4%)年龄较大,更可能是女性,合并症较多,更常见于严重的原发性 MR。手术方面和技术成功率不受 MAC 程度的影响,术后第一年的 MR 严重程度和功能状态与基线相比也有显著改善。然而,中度以上 MR 或功能 III 级和 IV 级在术后 1 年的持续情况以及术后 2 年再介入的累积发生率在轻度以上 MAC 组中总体上更为明显(明显 MR 或功能障碍,44.7% 对 29.9%,P=0.060;再介入,11.9% 对 6.2%,P=0.033;对数秩 P=0.035)。MAC程度与死亡率、死亡率或心力衰竭住院的累积发生率或风险之间没有关联。结果频率的差异主要局限于原发性MR亚组,其中轻度以上MAC患者的2年心衰住院时间更早、更频繁(20.8%对9.6%;P=0.016;对数秩P=0.020):二尖瓣经导管边缘对边缘修补术在轻度以上MAC患者和非轻度MAC患者中同样可行、安全;但在原发性MR患者中,其术后情况较差。
{"title":"Implications of Mitral Annular Calcification on Outcomes Following Mitral Transcatheter Edge-to-Edge Repair.","authors":"Alon Shechter, Mirae Lee, Danon Kaewkes, Vivek Patel, Ofir Koren, Tarun Chakravarty, Keita Koseki, Takashi Nagasaka, Sabah Skaf, Moody Makar, Raj R Makkar, Robert J Siegel","doi":"10.1161/CIRCINTERVENTIONS.123.013424","DOIUrl":"10.1161/CIRCINTERVENTIONS.123.013424","url":null,"abstract":"<p><strong>Background: </strong>Limited data exist regarding the impact of mitral annular calcification (MAC) on outcomes of transcatheter edge-to-edge repair for mitral regurgitation (MR).</p><p><strong>Methods: </strong>We retrospectively analyzed 968 individuals (median age, 79 [interquartile range, 70-86] years; 60.0% males; 51.8% with functional MR) who underwent an isolated, first-time intervention. Stratified by MAC extent per baseline transthoracic echocardiogram, the cohort was assessed for residual MR, functional status, all-cause mortality, heart failure hospitalizations, and mitral reinterventions post-procedure.</p><p><strong>Results: </strong>Patients with above-mild MAC (n=101; 10.4%) were older and more likely to be female, exhibited a greater burden of comorbidities, and presented more often with severe, primary MR. Procedural aspects and technical success rate were unaffected by MAC magnitude, as was the significant improvement from baseline in MR severity and functional status along the first postprocedural year. However, the persistence of above-moderate MR or functional classes III and IV at 1 year and the cumulative incidence of reinterventions at 2 years were overall more pronounced within the above-mild MAC group (significant MR or functional impairment, 44.7% versus 29.9%, <i>P</i>=0.060; reinterventions, 11.9% versus 6.2%, <i>P</i>=0.033; log-rank <i>P</i>=0.035). No link was demonstrated between MAC degree and the cumulative incidence or risk of mortality and mortality or heart failure hospitalizations. Differences in outcomes frequencies were mostly confined to the primary MR subgroup, in which patients with above-mild MAC also experienced earlier, more frequent 2-year heart failure hospitalizations (20.8% versus 9.6%; <i>P</i>=0.016; log-rank <i>P</i>=0.020).</p><p><strong>Conclusions: </strong>Mitral transcatheter edge-to-edge repair in patients with and without above-mild MAC is equally feasible and safe; however, its postprocedural course is less favorable among those with primary MR.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139485216","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}