Thomas K Jones, Doff B McElhinney, Julie A Vincent, William E Hellenbrand, John P Cheatham, Darren P Berman, Evan M Zahn, Danyal M Khan, John F Rhodes, Shicheng Weng, Lisa J Bergersen
{"title":"Long-Term Outcomes After Melody Transcatheter Pulmonary Valve Replacement in the US Investigational Device Exemption Trial.","authors":"Thomas K Jones, Doff B McElhinney, Julie A Vincent, William E Hellenbrand, John P Cheatham, Darren P Berman, Evan M Zahn, Danyal M Khan, John F Rhodes, Shicheng Weng, Lisa J Bergersen","doi":"10.1161/CIRCINTERVENTIONS.121.010852","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.121.010852","url":null,"abstract":"<p><strong>Background: </strong>The Melody valve was developed to extend the useful life of previously implanted right ventricular outflow tract (RVOT) conduits or bioprosthetic pulmonary valves, while preserving RV function and reducing the lifetime burden of surgery for patients with complex congenital heart disease.</p><p><strong>Methods: </strong>Enrollment for the US Investigational Device Exemption study of the Melody valve began in 2007. Extended follow-up was completed in 2020. The primary outcome was freedom from transcatheter pulmonary valve (TPV) dysfunction (freedom from reoperation, reintervention, moderate or severe pulmonary regurgitation, and/or mean RVOT gradient >40 mm Hg). Secondary end points included stent fracture, catheter reintervention, surgical conduit replacement, and death.</p><p><strong>Results: </strong>One hundred seventy-one subjects with RVOT conduit or bioprosthetic pulmonary valve dysfunction were enrolled. One hundred fifty underwent Melody TPV replacement. Median age was 19 years (Q1-Q3: 15-26). Median discharge mean RVOT Doppler gradient was 17 mm Hg (Q1-Q3: 12-22). The 149 patients implanted >24 hours were followed for a median of 8.4 years (Q1-Q3: 5.4-10.1). At 10 years, estimated freedom from mortality was 90%, from reoperation 79%, and from any reintervention 60%. Ten-year freedom from TPV dysfunction was 53% and was significantly shorter in children than in adults. Estimated freedom from TPV-related endocarditis was 81% at 10 years (95% CI, 69%-89%), with an annualized rate of 2.0% per patient-year.</p><p><strong>Conclusions: </strong>Ten-year outcomes from the Melody Investigational Device Exemption trial affirm the benefits of Melody TPV replacement in the lifetime management of patients with RVOT conduits and bioprosthetic pulmonary valves by providing sustained symptomatic and hemodynamic improvement in the majority of patients. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00740870.</p>","PeriodicalId":516631,"journal":{"name":"Circulation. Cardiovascular interventions","volume":" ","pages":"e010852"},"PeriodicalIF":5.6,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f3/5b/hcv-15-e010852.PMC8765216.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39604540","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Madeleine Barker, Amr E Abbas, John G Webb, Philippe Pibarot, Janarthanan Sathananthan, Nathan Brunner, Dee Dee Wang, Jia Wang, Martin B Leon, David A Wood
{"title":"Standardized Invasive Hemodynamics for Management of Patients With Elevated Echocardiographic Gradients Post-Transcatheter Aortic Valve Replacement at Midterm Follow-Up.","authors":"Madeleine Barker, Amr E Abbas, John G Webb, Philippe Pibarot, Janarthanan Sathananthan, Nathan Brunner, Dee Dee Wang, Jia Wang, Martin B Leon, David A Wood","doi":"10.1161/CIRCINTERVENTIONS.121.011243","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.121.011243","url":null,"abstract":"","PeriodicalId":516631,"journal":{"name":"Circulation. Cardiovascular interventions","volume":" ","pages":"e011243"},"PeriodicalIF":5.6,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39642190","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":"Response by Puymirat and Danchin to Letter Regarding Article, \"Compared Outcomes of ST-Elevation Myocardial Infarction Patients With Multivessel Disease Treated With Primary Percutaneous Coronary Intervention and Preserved Fractional Flow Reserve of Nonculprit Lesions Treated Conservatively and of Those With Low Fractional Flow Reserve Managed Invasively: Insights From the FLOWER MI Trial\".","authors":"Etienne Puymirat, Nicolas Danchin","doi":"10.1161/CIRCINTERVENTIONS.121.011614","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.121.011614","url":null,"abstract":"","PeriodicalId":516631,"journal":{"name":"Circulation. Cardiovascular interventions","volume":" ","pages":"e011614"},"PeriodicalIF":5.6,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39829356","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}
Fabio V Lima, Pratik Manandhar, Daniel Wojdyla, Tracy Wang, Herbert D Aronow, Vishnu Kadiyala, E Hope Weissler, Nidhi Madan, Ian C Gilchrist, Cindy Grines, J Dawn Abbott
{"title":"Percutaneous Coronary Intervention Following Diagnostic Angiography by Noninterventional Versus Interventional Cardiologists: Insights From the CathPCI Registry.","authors":"Fabio V Lima, Pratik Manandhar, Daniel Wojdyla, Tracy Wang, Herbert D Aronow, Vishnu Kadiyala, E Hope Weissler, Nidhi Madan, Ian C Gilchrist, Cindy Grines, J Dawn Abbott","doi":"10.1161/CIRCINTERVENTIONS.121.011086","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.121.011086","url":null,"abstract":"<p><strong>Background: </strong>There are limited contemporary, national data describing diagnostic cardiac catheterization with subsequent percutaneous coronary intervention (ad hoc percutaneous coronary intervention [PCI]) performed by an invasive-diagnostic and interventional (Dx/IC) operator team versus solo interventional operator (solo-IC). Using the CathPCI Registry, this study aimed at analyzing trends and outcomes in ad hoc PCI among Dx/IC versus solo-IC operators.</p><p><strong>Methods: </strong>Quarterly rates (January 2012 to March 2018) of ad hoc PCI cases by Dx/IC and solo-IC operators were obtained. Odds of inhospital major adverse cardiovascular events, net adverse cardiovascular events (ie, composite major adverse cardiovascular event+bleeding), and rarely appropriate PCI were estimated using multivariable regression.</p><p><strong>Results: </strong>From 1077 sites, 1 262 948 patients were included. The number of invasive-diagnostic operators and cases performed by Dx/IC teams decreased from nearly 9% to 5% during the study period. Patients treated by Dx/IC teams were more often White and had fewer comorbidities compared with patients treated by solo-IC operators. Considerable variation existed across sites, and over two-fifths of sites had 0% ad hoc PCI performed by Dx/IC. In adjusted analyses, ad hoc performed by Dx/IC had similar risks of major adverse cardiovascular event (OR, 1.04 [95% CI, 0.97-1.11]) and net adverse cardiovascular events (OR, 0.98 [95% CI, 0.94-1.03]) compared with solo-IC. Rarely appropriate PCI, although low overall (2.1% versus 1.9%) occurred more often by Dx/IC compared with solo-IC (OR, 1.20 [95% CI, 1.13-1.26]).</p><p><strong>Conclusions: </strong>Contemporary, nationwide data from the CathPCI Registry demonstrates the number of Dx/IC operator teams and cases has decreased but that case volume is stable among operators. Outcomes were independent of operator type, which supports current practice patterns. The finding of a higher risk of rarely appropriate PCI in Dx/IC teams should be further studied.</p>","PeriodicalId":516631,"journal":{"name":"Circulation. Cardiovascular interventions","volume":" ","pages":"e011086"},"PeriodicalIF":5.6,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39607045","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}
Mehdi H Shishehbor, Tarek A Hammad, Tonia J Rhone, Ahmad Younes, Norman Kumins, Abdullah Abdullah, Jun Li, Karem Harth, Teresa L Carman, Heather L Gornik, Peter J Pronovost, Vikram S Kashyap
{"title":"Impact of Interdisciplinary System-Wide Limb Salvage Advisory Council on Lower Extremity Major Amputation.","authors":"Mehdi H Shishehbor, Tarek A Hammad, Tonia J Rhone, Ahmad Younes, Norman Kumins, Abdullah Abdullah, Jun Li, Karem Harth, Teresa L Carman, Heather L Gornik, Peter J Pronovost, Vikram S Kashyap","doi":"10.1161/CIRCINTERVENTIONS.121.011306","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.121.011306","url":null,"abstract":"","PeriodicalId":516631,"journal":{"name":"Circulation. Cardiovascular interventions","volume":" ","pages":"e011306"},"PeriodicalIF":5.6,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39744029","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":"Response by Puymirat and Danchin to Letter Regarding Article, \"Compared Outcomes of ST-Segment-Elevation Myocardial Infarction Patients With Multivessel Disease Treated With Primary Percutaneous Coronary Intervention and Preserved Fractional Flow Reserve of Nonculprit Lesions Treated Conservatively and of Those With Low Fractional Flow Reserve Managed Invasively: Insights From the FLOWER-MI Trial\".","authors":"Etienne Puymirat, Nicolas Danchin","doi":"10.1161/CIRCINTERVENTIONS.121.011667","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.121.011667","url":null,"abstract":"","PeriodicalId":516631,"journal":{"name":"Circulation. Cardiovascular interventions","volume":" ","pages":"e011667"},"PeriodicalIF":5.6,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39829354","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}
Selai Akseer, Lusine Abrahamyan, Douglas S Lee, Ella Huszti, Lukas M Meier, Mark Osten, Lee Benson, Eric Horlick
{"title":"Long-Term Outcomes in Adult Patients With Pulmonary Hypertension After Percutaneous Closure of Atrial Septal Defects.","authors":"Selai Akseer, Lusine Abrahamyan, Douglas S Lee, Ella Huszti, Lukas M Meier, Mark Osten, Lee Benson, Eric Horlick","doi":"10.1161/CIRCINTERVENTIONS.121.011110","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.121.011110","url":null,"abstract":"<p><strong>Background: </strong>Pulmonary hypertension (PH), recently redefined as mean pulmonary arterial pressure >20 mm Hg (PH<sub>20</sub>), may be observed in patients with atrial septal defects (ASD). We aimed to determine the effect of preprocedural PH<sub>20</sub> status on outcomes among patients undergoing ASD closure.</p><p><strong>Methods: </strong>Study population was selected from a retrospective registry of adult patients who underwent percutaneous ASD closure from 1998 to 2016 from a single center and had right heart catheterizations during the procedure. The clinical registry was linked to administrative databases to capture short- and long-term outcomes.</p><p><strong>Results: </strong>We included a total of 632 ASD closure patients of whom 359 (56.8%) had PH<sub>20</sub>. The mean follow-up length was 7.6±4.6 years. Patients with PH<sub>20</sub> were older (mean age 56.5 versus 43.1 years, <i>P</i><0.001) and a higher prevalence of comorbidities including hypertension (54.3% versus 21.6%, <i>P</i><0.001) and diabetes (18.1% versus 5.9%, <i>P</i><0.001) than those without PH. In a Cox proportional hazards model after covariate adjustment, patients with PH had a significantly higher risk of developing major adverse cardiac and cerebrovascular events (heart failure, stroke, myocardial infarction, or cardiovascular mortality), with hazards ratio 2.45 (95% CI, 1.4-4.4). When applying the prior, mean pulmonary arterial pressure ≥25 mm Hg (PH<sub>25</sub>) cutoff, a significantly higher hazard of developing major adverse cardiac and cerebrovascular events was observed in PH versus non-PH patients.</p><p><strong>Conclusions: </strong>ASD patients with PH undergoing closure suffer from more comorbidities and worse long-term major adverse cardiac and cerebrovascular events outcomes, compared with patients without PH. The use of the new PH<sub>20</sub> definition potentially dilutes the effect of this serious condition on outcomes in this population.</p>","PeriodicalId":516631,"journal":{"name":"Circulation. Cardiovascular interventions","volume":" ","pages":"e011110"},"PeriodicalIF":5.6,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39590646","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}
Jason H Anderson, Allison K Cabalka, Robert P Frantz, Hector R Cajigas, Nathaniel W Taggart
{"title":"Transcatheter Nonductal Reverse Potts Shunt Creation in Pulmonary Arterial Hypertension.","authors":"Jason H Anderson, Allison K Cabalka, Robert P Frantz, Hector R Cajigas, Nathaniel W Taggart","doi":"10.1161/CIRCINTERVENTIONS.121.011315","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.121.011315","url":null,"abstract":"","PeriodicalId":516631,"journal":{"name":"Circulation. Cardiovascular interventions","volume":" ","pages":"e011315"},"PeriodicalIF":5.6,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39744027","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}
Matthias Aurich, Martin J Volz, Derliz Mereles, Nicolas A Geis, Norbert Frey, Mathias H Konstandin, Philip W Raake
{"title":"Initial Experience With the PASCAL Ace Implant System for Treatment of Severe Tricuspid Regurgitation.","authors":"Matthias Aurich, Martin J Volz, Derliz Mereles, Nicolas A Geis, Norbert Frey, Mathias H Konstandin, Philip W Raake","doi":"10.1161/CIRCINTERVENTIONS.121.010770","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.121.010770","url":null,"abstract":"<p><p>[Figure: see text].</p>","PeriodicalId":516631,"journal":{"name":"Circulation. Cardiovascular interventions","volume":" ","pages":"e010770"},"PeriodicalIF":5.6,"publicationDate":"2021-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39343226","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}