Aljoscha Rastan, Marianne Brodmann, Tanja Böhme, Roland Macharzina, Elias Noory, Ulrich Beschorner, Peter-Christian Flügel, Karlheinz Bürgelin, Franz-Josef Neumann, Thomas Zeller
{"title":"Atherectomy and Drug-Coated Balloon Angioplasty for the Treatment of Long Infrapopliteal Lesions: A Randomized Controlled Trial.","authors":"Aljoscha Rastan, Marianne Brodmann, Tanja Böhme, Roland Macharzina, Elias Noory, Ulrich Beschorner, Peter-Christian Flügel, Karlheinz Bürgelin, Franz-Josef Neumann, Thomas Zeller","doi":"10.1161/CIRCINTERVENTIONS.120.010280","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.120.010280","url":null,"abstract":"<p><strong>Background: </strong>Prospective, randomized, multicenter trials show no beneficial impact of drug-coated balloon (DCB) therapy alone on the technical and clinical outcomes of infrapopliteal artery lesions in comparison to plain old balloon angioplasty. The aim of this study was to evaluate the performance of directional atherectomy (DA) plus DCB angioplasty versus DCB alone in treatment of long infrapopliteal artery lesions.</p><p><strong>Methods: </strong>We conducted a prospective, randomized, 2-center trial comparing the performance of DA+DCB and DCB alone in treatment of 80 patients with de novo infrapopliteal artery lesions. The primary study end point was the 6-month primary patency of the target lesion detected by angiography and duplex ultrasound. Secondary end points included clinically driven target vessel revascularization, amputation rates, and changes in Rutherford-Becker class at 1 year. A core laboratory provides independent analyses for all scheduled and unscheduled duplex ultrasound examinations and angiographies, and a research institute ensured independent data collection.</p><p><strong>Results: </strong>The mean target lesion length was 179.7±98.2 mm. Nine patients (11.3%) died during the follow-up period. At 6 months, primary patency was 49% (n=18) with DA+DCB versus 34% (n=12) with DCB alone (P=0.241), and clinically driven target vessel revascularization was 8% (n=3) versus 14% (n=5; P=0.475), respectively. At 1 year, the target lesion revascularization rates were 30% (n=10) versus 43% (n=12; P=0.308), the median in Rutherford-Becker class was 2 (0.25–5) versus 5 (0.25–5; P=0.329), and amputation rates were 22% (n=8) versus 32% (n=11; P=0.618) in the DA+DCB group and the DCB group, respectively.</p><p><strong>Conclusions: </strong>Treatment of long infrapopliteal artery lesions with DA+DCB versus DCB alone leads to comparable clinical and technical results at 6 months and 1 year.</p><p><strong>Registration: </strong>https://www.clinicaltrials.gov; Unique identifier: NCT01763476.</p>","PeriodicalId":516631,"journal":{"name":"Circulation. Cardiovascular interventions","volume":" ","pages":"e010280"},"PeriodicalIF":5.6,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39064163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Takashi Kido, Alvise Guariento, Ilias P Doulamis, Diego Porras, Christopher W Baird, Pedro J Del Nido, Meena Nathan
{"title":"Aortic Valve Surgery After Neonatal Balloon Aortic Valvuloplasty in Congenital Aortic Stenosis.","authors":"Takashi Kido, Alvise Guariento, Ilias P Doulamis, Diego Porras, Christopher W Baird, Pedro J Del Nido, Meena Nathan","doi":"10.1161/CIRCINTERVENTIONS.120.009933","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.120.009933","url":null,"abstract":"<p><strong>Background: </strong>We sought to identify predictive factors for aortic valve (AoV) surgery after neonatal balloon aortic valvuloplasty (BAV) and characterize clinical outcomes of AoV surgery after neonatal BAV.</p><p><strong>Methods: </strong>Time-to-event analysis identified predictors for AoV surgery after neonatal BAV. Clinical outcomes of AoV surgery following neonatal BAV were examined.</p><p><strong>Results: </strong>This study included 96 consecutive patients who underwent neonatal BAV for congenital aortic stenosis between 1998 and 2018, in 26 of whom a fetal BAV had been performed. Fifty-six patients underwent AoV surgery at a median age of 2.0 years. Significant risk factors for AoV surgery in univariate Cox regression (result presented as hazard ratio [HR], [95% CI]; P value) were a history of fetal BAV (HR, 4.05 [95% CI, 2.19–7.40]; P<0.001), AoV annulus diameter Z score (HR, 0.56 [95% CI, 0.43–0.75]; P=0.001), the presence of endocardial fibroelastosis (HR, 2.61 [95% CI, 1.48–4.51]; P=0.001), severe left ventricular dysfunction before neonatal BAV (HR, 1.75 [95% CI, 1.03–2.97]; P=0.04), and recent era (HR, 3.08 [95% CI, 1.68–5.91]; P=0.0002) in the entire cohort. Area under the receiver operating characteristic curve and Youden J index analysis identified a cutoff value for AoV annulus diameter Z score of −2.6 in patients without fetal BAV. In 24 patients with midterm cardiac catheterization data, univariate linear regression analysis (result presented as B coefficient [95% CI]; P) showed that the presence of greater-than-moderate aortic regurgitation immediately after BAV (B coefficient, 4.8 [95% CI, 1.0–8.6]; P=0.018) and before AoV surgery (B coefficient, 6.1 [95% CI, 2.2–10.0]; P=0.004) were significant risk factors for elevated left ventricular end-diastolic pressure after AoV surgery, while concomitant endocardial fibroelastosis resection at AoV surgery had a protective effect (B coefficient, −3.8 [95% CI, −7.6 to −0.06]; P=0.05).</p><p><strong>Conclusions: </strong>A small AoV annulus diameter Z score with a cutoff value of −2.6 and a history of fetal BAV were significantly associated with AoV surgery after neonatal BAV. Concomitant endocardial fibroelastosis resection is recommended at AoV surgery following neonatal BAV to improve left ventricular diastolic function.</p>","PeriodicalId":516631,"journal":{"name":"Circulation. Cardiovascular interventions","volume":" ","pages":"e009933"},"PeriodicalIF":5.6,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39064164","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Luca Testa, Mauro Agnifili, Nicolas M Van Mieghem, Didier Tchétché, Anita W Asgar, Ole De Backer, Azeem Latib, Bernhard Reimers, Giulio Stefanini, Carlo Trani, Antonio Colombo, Francesco Giannini, Antonio Bartorelli, Wojtek Wojakowski, Maciej Dabrowski, Dariusz Jagielak, Adrian P Banning, Rajesh Kharbanda, Raul Moreno, Joachim Schofer, Niels van Royen, Duane Pinto, Antoni Serra, Amit Segev, Arturo Giordano, Nedy Brambilla, Antonio Popolo Rubbio, Matteo Casenghi, Jacopo Oreglia, Federico De Marco, Rudolph Tanja, James M McCabe, Alexander Abizaid, Michiel Voskuil, Rui Teles, Giuseppe Biondi Zoccai, Giovanni Bianchi, Lars Sondergaard, Francesco Bedogni
{"title":"Transcatheter Aortic Valve Replacement for Degenerated Transcatheter Aortic Valves: The TRANSIT International Project.","authors":"Luca Testa, Mauro Agnifili, Nicolas M Van Mieghem, Didier Tchétché, Anita W Asgar, Ole De Backer, Azeem Latib, Bernhard Reimers, Giulio Stefanini, Carlo Trani, Antonio Colombo, Francesco Giannini, Antonio Bartorelli, Wojtek Wojakowski, Maciej Dabrowski, Dariusz Jagielak, Adrian P Banning, Rajesh Kharbanda, Raul Moreno, Joachim Schofer, Niels van Royen, Duane Pinto, Antoni Serra, Amit Segev, Arturo Giordano, Nedy Brambilla, Antonio Popolo Rubbio, Matteo Casenghi, Jacopo Oreglia, Federico De Marco, Rudolph Tanja, James M McCabe, Alexander Abizaid, Michiel Voskuil, Rui Teles, Giuseppe Biondi Zoccai, Giovanni Bianchi, Lars Sondergaard, Francesco Bedogni","doi":"10.1161/CIRCINTERVENTIONS.120.010440","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.120.010440","url":null,"abstract":"<p><strong>Background: </strong>Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bioprostheses is still a matter of concern, and little is known about the management of degenerated TAV. We sought to evaluate the outcomes of patients with a degenerated TAV treated by means of a second TAVR.</p><p><strong>Methods: </strong>The TRANSIT is an international registry that included cases of degenerated TAVR from 28 centers. Among around 40 000 patients treated with TAVR in the participating centers, 172 underwent a second TAVR: 57 (33%) for a mainly stenotic degenerated TAV, 97 (56%) for a mainly regurgitant TAV, and 18 (11%) for a combined degeneration. Overall, the rate of New York Heart Association class III/IV at presentation was 73.5%.</p><p><strong>Results: </strong>Valve Academic Research Consortium 2 device success rate was 79%, as a consequence of residual gradient (14%) or regurgitation (7%). At 1 month, the overall mortality rate was 2.9%, while rates of new hospitalization and New York Heart Association class III/IV were 3.6% and 7%, respectively, without significant difference across the groups. At 1 year, the overall mortality rate was 10%, while rates of new hospitalization and New York Heart Association class III/IV were 7.6% and 5.8%, respectively, without significant difference across the groups. No cases of valve thrombosis were recorded.</p><p><strong>Conclusions: </strong>Selected patients with a degenerated TAV may be safely and successfully treated by means of a second TAVR. This finding is of crucial importance for the adoption of the TAVR technology in a lower risk and younger population.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT04500964.</p>","PeriodicalId":516631,"journal":{"name":"Circulation. Cardiovascular interventions","volume":" ","pages":"e010440"},"PeriodicalIF":5.6,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39064166","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mila Kovacevic, Francesco Burzotta, Sameh Elharty, George Besis, Cristina Aurigemma, Enrico Romagnoli, Carlo Trani
{"title":"Left Main Trifurcation and Its Percutaneous Treatment: What Is Known So Far?","authors":"Mila Kovacevic, Francesco Burzotta, Sameh Elharty, George Besis, Cristina Aurigemma, Enrico Romagnoli, Carlo Trani","doi":"10.1161/CIRCINTERVENTIONS.120.009872","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.120.009872","url":null,"abstract":"<p><p>In humans, the most common anatomic variation of the left main (LM) stem is represented by its distal division in 3 branches (LM trifurcation) instead of 2. LM trifurcation disease accounts for ≈10% to 15% of all LM diseases and is often managed by cardiac surgery. Over the last decades, due to the improvement of interventional material and techniques, percutaneous coronary intervention started gaining acceptance to treat patients with LM disease including those with trifurcated anatomy. Yet, LM trifurcation stenosis with its intrinsic anatomic complexity (3 branches, at least 4 angles, wide variability in branch size and disease) is recognized as a challenging lesion subset for percutaneous coronary intervention. In this review, we summarize available data about LM trifurcation anatomy, its influence on percutaneous coronary intervention feasibility, and the evidence collected regarding the different technical options (including trissing balloon inflation).</p>","PeriodicalId":516631,"journal":{"name":"Circulation. Cardiovascular interventions","volume":" ","pages":"e009872"},"PeriodicalIF":5.6,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25449003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Optical Coherence Tomography Versus Intravascular Ultrasound Versus Angiography, Once Again.","authors":"Akiko Maehara","doi":"10.1161/CIRCINTERVENTIONS.121.010593","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.121.010593","url":null,"abstract":"","PeriodicalId":516631,"journal":{"name":"Circulation. Cardiovascular interventions","volume":" ","pages":"e010593"},"PeriodicalIF":5.6,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25448929","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correction to: Self-Expandable Nitinol Stents for the Treatment of Nonmalignant Deep Venous Obstruction.","authors":"","doi":"10.1161/HCV.0000000000000081","DOIUrl":"https://doi.org/10.1161/HCV.0000000000000081","url":null,"abstract":"","PeriodicalId":516631,"journal":{"name":"Circulation. Cardiovascular interventions","volume":" ","pages":"e000081"},"PeriodicalIF":5.6,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25483003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}