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Data for nearly all patients undergoing transcatheter edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR) with an approved device in the United States is captured in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. All data submitted for TEER or TMVR between 2014 and March 31, 2020, are reported. A total of 37,475 patients underwent a mitral transcatheter procedure, including 33,878 TEER and 3,597 TMVR. Annual procedure volumes for TEER have increased from 1,152 per year in 2014 to 10,460 per year in 2019 at 403 sites and for TMVR from 84 per year to 1,120 per year at 301 centers. Mortality rates have decreased for TEER at 30 days (5.6%-4.1%) and 1 year (27.4%-22.0%). Early off-label use data on TMVR in mitral valve-in-valve therapy led to approval by the U.S. Food and Drug Administration in 2017, and the 2019 30-day mortality rate was 3.9%. Overall improvements in outcomes over the last 6 years are apparent. (STS/ACC TVT Registry Mitral Module; NCT02245763)., (Copyright © 2022 The Society of Thoracic Surgeons and The American College of Cardiology Foundation. Published by Elsevier Inc. Published by Elsevier Inc. All rights reserved.)

Data for nearly all patients undergoing transcatheter edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR) with an approved device in the United States is captured in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. All data submitted for TEER or TMVR between 2014 and March 31, 2020, are reported. A total of 37,475 patients underwent a mitral transcatheter procedure, including 33,878 TEER and 3,597 TMVR. Annual procedure volumes for TEER have increased from 1,152 per year in 2014 to 10,460 per year in 2019 at 403 sites and for TMVR from 84 per year to 1,120 per year at 301 centers. Mortality rates have decreased for TEER at 30 days (5.6%-4.1%) and 1 year (27.4%-22.0%). Early off-label use data on TMVR in mitral valve-in-valve therapy led to approval by the U.S. Food and Drug Administration in 2017, and the 2019 30-day mortality rate was 3.9%. Overall improvements in outcomes over the last 6 years are apparent. (STS/ACC TVT Registry Mitral Module; NCT02245763)., Competing Interests: Funding Support and Author Disclosures Dr Mack has served as uncompensated co–principal investigator for the Partner 3 Trial by Edwards Lifesciences, study chair for the Apollo Trial by Medtronic, and co–principal investigator for the Coapt Trial by Abbott, receiving only travel expenses for trial-related meetings. Dr Carroll has been a local investigator for Abbott (COAPT, TRILUMINATE, and EXPAND clinical trials), Edwards Lifesciences (PARTNER 2 and CLASP clinical trials), and Medtronic (Low Risk TAVR clinical trial; has been the chair of the data and safety monitoring board for Abbott Tendyne clinical trial; and has been a steering committee member for the Abbott RESPECT clinical trial. Dr Thourani has received consultancy and research grants from Abbott and Edwards Lifesciences. Dr Vemulapalli has received grants/contracts from Abbott, Boston Scientific, American College of Cardiology, Society of Thoracic Surgeons, National Institutes of Health, National Evaluation System for health Technology Coordinating Center (FDA); and has received consulting fees/served on the advisory board/Speakers Bureau for Boston Scientific, Janssen, HeartFlow, and American College of Physicians. Dr Deeb has been an executive committee and investigator for all the Medtronic TAVR Trials; has served on the surgical Advisory Committee for Medtronic; and has served on the data management committee for the Medtronic EV-ICD Trial (no personal reimbursement). Dr Batchelor has served as a consultant for V-Wave, Medtronic, Abbott, Boston Scientific, and Idorsia; and has received research support from Abbott and Boston Scientific. Dr Herrmann has received institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; has received consultant fees from Edwards Lifesciences and Medtronic; and has equity in Microinterventional Devices. Dr Cohen has received research grant support and consulting income from Abbott, Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Hanzel has served as a local investigator for Abbott (COAPT and Summit clinical trials), Boston Scientific (REPRISE III and REPRISE IV clinical trials), and Edwards Lifesciences (PARTNER 2 and PARNTER 3 clinical trials). Dr Gleason serves on the medical advisory board for Abbott. Dr Kirtane has received institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, and ReCor Medical; has received institutional funding, including fees paid to Columbia University and/or Cardiovascular Research Foundation for speaking engagements and/or consulting; has received consulting fees from Neurotronic; and has received travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr Desai has received speaking fees from Medtronic, Gore, and Terumo; and has received research grants from Gore and Medtronic. Dr Brindis serves as Senior Medical Officer, External Affairs, ACC National Cardiovascular Data Registry. Dr Masoudi has a contract with the ACC for his role as Chief Scientific Advisor, National Cardiovascular Data Registry. Dr Bavaria has served as a site principal investigator on clinical trials for Edwards Lifesciences, Medtronic, W.L. Gore, and Abbott; has served as a consultant for Edwards Lifesciences, W.L. Gore, and Abbott; has served on the Speakers Bureau for Medtronic; and has served as data and safety monitoring board chair for Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 by The American College of Cardiology Foundation and The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration-approved transcatheter valve devices performed in the United States, and is mandated as a condition of reimbursement by the Centers for Medicaid & Medicare Services., Objectives: This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States., Methods: We reviewed data for all patients receiving commercially approved devices from 2012 through December 31, 2015, that are entered in the TVT Registry., Results: The 54,782 patients with transcatheter aortic valve replacement demonstrated decreases in expected risk of 30-day operative mortality (STS Predicted Risk of Mortality [PROM]) of 7% to 6% and transcatheter aortic valve replacement PROM (TVT PROM) of 4% to 3% (both p < 0.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9%, and 1-year mortality decreased from 25.8% to 21.6%. However, 30-day post-procedure pacemaker insertion increased from 8.8% in 2013 to 12.0% in 2015. The 2,556 patients who underwent transcatheter mitral leaflet clip in 2015 were similar to patients from 2013 to 2014, with hospital mortality of 2% and with mitral regurgitation reduced to grade ≤2 in 87% of patients (p < 0.0001). The 349 patients who underwent mitral valve-in-valve and mitral valve-in-ring procedures were high risk, with an STS PROM for mitral valve replacement of 11%. The observed hospital mortality was 7.2%, and 30-day post-procedure mortality was 8.5%., Conclusions: The TVT Registry is an innovative registry that that monitors quality, patient safety and trends for these rapidly evolving new technologies., (Copyright © 2017 American College of Cardiology Foundation and The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background and Aim of the Study: Mitral regurgitation (MR) is frequently present in patients with calcific aortic stenosis (AS). Yet, the issue of whether to surgically correct the MR during aortic valve replacement (AVR) remains uncertain. The study aim was to define the outcome of MR after transcatheter aortic valve implantation (TAVI) in the TRanscatheter EndoVascular Implantation of VALves (REVIVAL) II trial., Methods: Echocardiography was performed before and at 24 h, and three and six months after valve implantation. The degree of MR was evaluated by expert readers and by the vena contracta (VC) method. Significant MR was defined as at least mild to moderate MR. Those patients with a 30% reduction in VC were classified as good responders (GR group), and the remainder as poor responders (PR group)., Results: The study comprised 35 subjects with at least mild to moderate MR before TAVI. The mean VC of the whole group declined from 0.5 +/- 0.2 cm initially to 0.32 +/- 0.2 cm and 0.38 +/- 0.2 cm at 24 h and three months, respectively (p < 0.05). At three months, 12 patients had > 30% VC reduction; these constituted the GR group, while the remainder constituted the PR group. The percentage of patients with mitral annular calcification with restriction (MACr), defined as calcification encroaching onto the leaflets and restricting leaflet motion, was significantly lower in the GR group compared to the PR group (17% versus 61%, respectively; p < 0.05). The remaining pre-specified parameters did not differ significantly between the GR and PR groups, including age, gender, mitral valve tethering height and area (6 +/- 2 mm versus 5 +/- 3 mm and 10 +/- 4 mm2 versus 13 +/- 9 and 10 +/- 4 mm2, respectively), change in the aortic valve area (336 +/- 130% versus 285 +/- 180%), change in mean systolic aortic valve pressure (-20 +/- 8% versus - 23 +/- 10%), and left ventricular ejection fraction (47 +/- 15% versus 45 +/- 18%)., Conclusion: MR is improved significantly after TAVI for AS. MACr was the only variable associated with a reduction in MR improvement. These results suggest that a careful echocardiographic evaluation of the mitral valve prior to TAVI may help to predict which patients should experience an improvement in their MR.

Transcatheter aortic valve implantation (TAVI) with the Cribier-Edwards prosthesis may provide an alternative to conventional aortic valve replacement in high-risk patients with aortic stenosis. Previous studies have indicated that TAVI is feasible in this patient population. Transcatheter implantation of a Cribier-Edwards prosthesis was attempted in 55 patients in a United States Food and Drug Administration-approved prospective observational study. Clinical and echocardiographic outcomes were assessed in hospital and at 30 days, 6 months, and 12 months. Fifty-five patients (55% women, mean age 83 years) with a mean aortic valve area of 0.57 ± 0.14 cm(2) and a mean logistic European System for Cardiac Operative Risk Evaluation score of 33.5 ± 17.0% were enrolled. Transcatheter heart valves were implanted successfully in 48 patients (87%). Mean echocardiographic aortic valve area improved from 0.56 ± 0.14 to 1.6 ± 0.48 cm(2) after the procedure (p <0.0001). Thirty-day all-cause mortality and major adverse cardiac and cerebrovascular events were 7.3% and 20%, respectively. There were also 7 major procedural vascular complications (12.7%). Mortality and major adverse cardiac and cerebrovascular events increased to 23.6% and 32.7%, respectively, at 1 year, with most late events related to underlying co-morbidities. Mean New York Heart Association functional class improved from 3.22 ± 0.66 at baseline to 1.50 ± 0.85 at 1 year follow-up (p <0.001). In conclusion, TAVI in high-risk patients with aortic stenosis was feasible, with sustained clinical benefit at 12 months. Procedural complications and late major adverse cardiac and cerebrovascular events, however, overshadowed the overall clinical benefit of TAVI in this high-risk patient population., (Copyright © 2011 Elsevier Inc. All rights reserved.)