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1-Year Clinical Outcomes in Women After Transcatheter Aortic Valve Replacement: Results From the First WIN-TAVI Registry
Conclusions Intermediate to high-risk women enrolled in this first ever all-women contemporary TAVR registry experienced a 1-year VARC-2 composite efficacy endpoint of 16.5%, with a low incidence of 1-year mortality and stroke. Prior revascularization and EuroSCORE I were independent predictors of the VARC-2 efficacy endpoint, whereas EuroSCORE I, baseline atrial fibrillation, and prior percutaneous coronary intervention were independent predictors of the 1-year death or stroke.
Source: Journal of the American College of Cardiology: Cardiovascular Interventions - January 1, 2018 Category: Cardiology Authors: Chieffo, A., Petronio, A. S., Mehilli, J., Chandrasekhar, J., Sartori, S., Lefevre, T., Presbitero, P., Capranzano, P., Tchetche, D., Iadanza, A., Sardella, G., Van Mieghem, N. M., Meliga, E., Dumonteil, N., Fraccaro, C., Trabattoni, D., Mikhail, G., Shar Tags: Focus on Cardiovascular Outcomes Among Women Source Type: research

Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap
Conclusions The safety and efficacy results of this study support the use of the Evolut PRO System for the treatment of severe symptomatic aortic stenosis in patients who are at increased surgical risk, resulting in excellent hemodynamics and minimal paravalvular leak (The Medtronic TAVR 2.0 US Clinical Study; NCT02738853)
Source: Journal of the American College of Cardiology: Cardiovascular Interventions - January 15, 2018 Category: Cardiology Authors: Forrest, J. K., Mangi, A. A., Popma, J. J., Khabbaz, K., Reardon, M. J., Kleiman, N. S., Yakubov, S. J., Watson, D., Kodali, S., George, I., Tadros, P., Zorn, G. L., Brown, J., Kipperman, R., Saul, S., Qiao, H., Oh, J. K., Williams, M. R. Tags: Structural: Focus on TAVR Source Type: research

A Composite Metric for Benchmarking Site Performance in TAVR: Results from the STS/ACC TVT Registry
Conclusions: There are substantial variations in the quality of TAVR care received in the United States, and 11% of sites were identified as providing care below the average level of performance. Further study is necessary to determine structural, process-related, and technical factors associated with high- and low-performing sites.PMID:33947202 | DOI:10.1161/CIRCULATIONAHA.120.051456
Source: Circulation - May 5, 2021 Category: Cardiology Authors: Nimesh D Desai Sean M O'Brien David J Cohen John Carroll Sreekanth Vemulapalli Suzanne V Arnold John K Forrest Vinod H Thourani Ajay J Kirtane Brian O'Neill Pratik Manandhar David M Shahian Vinay Badhwar Joseph E Bavaria Source Type: research

Comparison of a Complete Percutaneous versus Surgical Approach to Aortic Valve Replacement and Revascularization in Patients at Intermediate Surgical Risk: Results from the Randomized SURTAVI Trial.
CONCLUSIONS: For patients at intermediate surgical risk with severe AS and non-complex CAD (SYNTAX score ≤ 22), a complete percutaneous approach of TAVR and PCI is a reasonable alternative to SAVR and CABG. CLINICAL TRIAL REGISTRATION: URL: www.clinicaltrials.gov Unique Identifier: NCT01586910. PMID: 31476897 [PubMed - as supplied by publisher]
Source: Circulation - September 2, 2019 Category: Cardiology Authors: Søndergaard L, Popma JJ, Reardon MJ, Van Mieghem NM, Deeb GM, Kodali S, George I, Williams MR, Yakubov SJ, Kappetein AP, Serruys PW, Grube E, Schiltgen MB, Chang Y, Engstrøm T, SURTAVI Trial Investigators Tags: Circulation Source Type: research

Current Role of the Total Artificial Heart in the Management of Advanced Heart Failure
AbstractThe total artificial heart (TAH) is a form of mechanical circulatory support that involves resection of the native ventricles followed by placement of a device that can restore total pulmonary and systemic flow. Given the increasing burden of congestive heart failure and cardiovascular disease, the number of people in need of cardiac replacement therapy will continue to grow. Despite aggressive efforts to expand the donor pool, the number of heart transplants in the United States (US) has plateaued at less than 3000 per year. In addition, there is increasing recognition of the long-term complications of current gen...
Source: Current Cardiology Reports - November 21, 2019 Category: Cardiology Source Type: research

The Lotus Valve System: an In-depth Review of the Technology
AbstractPurpose of ReviewInnovation for transcatheter aortic valve replacement (TAVR) has transformed a medically complex treatment into a standardized procedure. While Edwards SAPIEN and Medtronic CoreValve occupy the market for TAVR in the United States (US), additional valve systems are being developed. The Boston Scientific Lotus Valve system was recently FDA-approved and will represent the third valve in the US market. This evidence-based review will summarize advantages, disadvantages, and projected impact of this new TAVR system.Recent FindingsThe Lotus Valve system demonstrates superiority in terms of rates of para...
Source: Current Cardiology Reports - November 24, 2019 Category: Cardiology Source Type: research

Benefit-Risk Tradeoffs in Assessment of New Drugs and Devices.
Abstract Balancing benefits and risks is a complex task that poses a major challenge, both to the approval of new medicines and devices by regulatory authorities and in therapeutic decision-making in practice. Several analysis methods and visualization tools have been developed to help evaluate and communicate whether the benefit-risk profile is favorable or unfavorable. In this White Paper, we describe approaches to benefit-risk assessment using qualitative approaches such as the Benefit Risk Action Team framework developed by the Pharmaceutical Research and Manufacturers of America, and the Benefit-Risk Framewor...
Source: Circulation - November 17, 2020 Category: Cardiology Authors: Kaul S, Stockbridge N, Butler J Tags: Circulation Source Type: research

Safety of Conscious Sedation for Transcatheter Aortic Valve Replacement Without an Anesthetist.
CONCLUSIONS: In this modest-sized transfemoral TAVR cohort with a low conversion rate to emergency surgery, TAVR-NA was associated with safety outcomes that were equivalent to TAVR-A. In healthcare systems where access to TAVR may be limited by anesthetic resources, TAVR-NA appears to be a reasonable option to enable the application of this therapy. PMID: 33542161 [PubMed - as supplied by publisher]
Source: The Journal of Invasive Cardiology - February 7, 2021 Category: Cardiology Tags: J Invasive Cardiol Source Type: research

Feasibility of Sentinel Cerebral Embolic Protection Device Deployment During Transfemoral Transcatheter Aortic Valve Replacement
Cerebral embolic protection has emerged as a preventive measure for procedural stroke in transcatheter aortic valve replacement (TAVR).1 The Sentinel System (Boston Scientific Corp. Boston, Massachusetts), a 2-filter debris-capturing system, has been the only commercially available protection device in the United States since its approval by the Food and Drug Administration in 2017. In the Sentinel trial, the largest randomized trial (n  = 363) so far, the device was successfully deployed in 94.7% of patients.
Source: The American Journal of Cardiology - October 1, 2022 Category: Cardiology Authors: Toshiaki Isogai, Husitha Reddy Vanguru, Amar Krishnaswamy, Ankit Agrawal, Nikolaos Spilias, Shashank Shekhar, Anas M. Saad, Beni Rai Verma, Rishi Puri, Grant W. Reed, Zoran B. Popovi ć, Shinya Unai, James J. Yun, Ken Uchino, Samir R. Kapadia Source Type: research

Economic Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis and Low Surgical Risk: Results from the PARTNER 3 Trial
CONCLUSIONS: For patients with severe aortic stenosis and low surgical risk similar to those enrolled in the PARTNER 3 trial, transfemoral TAVR with the SAPIEN 3 valve is cost saving compared with SAVR at 2 years and is projected to be economically attractive in the long run as long as there are no substantial differences in late death between the 2 strategies. Long-term follow-up will be critical to ultimately determine the preferred treatment strategy for low-risk patients from both a clinical and economic perspective.PMID:37154049 | DOI:10.1161/CIRCULATIONAHA.122.062481
Source: Circulation - May 8, 2023 Category: Cardiology Authors: Benjamin Z Galper Khaja M Chinnakondepalli Kaijun Wang Elizabeth A Magnuson Michael Lu Vinod H Thourani Susheel Kodali Raj Makkar Howard C Herrmann Samir Kapadia Mathew Williams John Webb Craig R Smith Michael J Mack Martin B Leon David J Cohen PARTNER In Source Type: research