STS/ACC Transcatheter Valve Therapy Registry (TVT Registry)

Официальное название

Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry (STS/ACC TVT Registry).

Обзор

The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world outcomes related to the transcatheter aortic valve replacement (TAVR) procedure. Created by The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), the TVT Registry is designed to monitor the safety and efficacy of this new procedure for the treatment of aortic stenosis.

Подробное описание

Purpose of the Registry

The TVT Registry was designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies. Patient-level data are submitted by participating hospitals to The Society of Thoracic Surgeons (STS) and American College of Cardiology Foundation's (ACCF) joint TVT Registry. The purposes of the TVT Registry include: (i) collecting pertinent and standardized data elements from participating hospitals, health care providers and others that measure and assess the quality of care for patients receiving TVT; (ii) providing confidential periodic reports to participating hospitals, health care providers and others, to evaluate and improve the quality of care in these areas; and (iii) permitting and fostering appropriate research based upon the data collected by means of the TVT Registry.

The secondary aim of the TVT Registry is to serve as a scalable data infrastructure for post market studies.

Background and Significance

Transcatheter valve therapies are now emerging into clinical practice from the research phase in the United States. The first of several approaches to replacing the aortic valve without open-chest surgery has now become a reality. Other valve and delivery systems are expected to be approved in the upcoming years. An Expert Consensus Document on Transcatheter Valve Therapy has outlined the initial technology, targeted patient population, and the multidisciplinary heart team and specialized facilities needed. The document also proposes the establishment of a national registry of patients with valvular heart disease that can collect and analyze data as these new valve treatment options become available. Surveillance of device performance, monitoring of long-term outcomes, and performance of comparative effectiveness research are some of the proposed uses of the registry.

Transcatheter valve therapies have emerged because of unmet patient needs. Furthermore, TVT has developed at a time when degenerative heart valve diseases of both the mitral and aortic valves are increasing in frequency as the population ages. With the introduction of the first TAVR commercial product, the targeted patient group is the "inoperable" patient who cannot receive the traditional therapy of surgical aortic valve replacement (SAVR). It is expected that TAVR will subsequently be extended to patients who have high risk with SAVR. The marked reduction of mortality by TAVR in the inoperable patients and the similar mortality of TAVR versus SAVR in the high risk patients provide patients with a new therapy with benefits but also with a different risk profile. Patients and their families will need to make informed decisions regarding the likelihood of having a mortality benefit, of improving their functional class and quality of life, of suffering a complication, and of choosing between different care options and therapeutic approaches.

For these patients there are unique issues such as the prioritization of the health related quality of life versus the quantity of life, the desire to preserve independence and avoid becoming a burden to families, and the need to clearly understand what about their current condition is reversible versus irreversible and linked to other conditions and aging. These issues become further highlighted when considering the considerable costs and other treatment burdens of the TVT technologies versus the disabling symptoms and recurrent hospitalizations caused by untreated severe valvular heart disease.

Вмешательства

• Процедура Transcatheter Aortic Valve Replacement
  Minimal invasive implantation of a biological prothesis in Aortic Position

Первичные конечные точки

• Major adverse cardiac and cerebrovascular events [Срок оценки: 30 day]

Вторичные конечные точки (1)

• Mortality [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 18 years or older

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• American College of Cardiology — Washington D.C.

Публикации

• Tang GHL, Sengupta A, Alexis SL, Bapat VN, Adams DH, Sharma SK, Kini AS, Kodali SK, Ramlawi B, Gada H, Vora AN, Forrest JK, Kaple RK, Liu F, Reardon MJ. Outcomes of Prosthesis-Patient Mismatch Following Supra-Annular Transcatheter Aortic Valve Replacement: From the STS/ACC TVT Registry. JACC Cardiovasc Interv. 2021 May 10;14(9):964-976. doi: 10.1016/j.jcin.2021.03.040. PMID 33958170
• Carroll JD, Mack MJ, Vemulapalli S, Herrmann HC, Gleason TG, Hanzel G, Deeb GM, Thourani VH, Cohen DJ, Desai N, Kirtane AJ, Fitzgerald S, Michaels J, Krohn C, Masoudi FA, Brindis RG, Bavaria JE. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. Ann Thorac Surg. 2021 Feb;111(2):701-722. doi: 10.1016/j.athoracsur.2020.09.002. Epub 2020 Nov 16. PMID 33213826
• Carroll JD, Mack MJ, Vemulapalli S, Herrmann HC, Gleason TG, Hanzel G, Deeb GM, Thourani VH, Cohen DJ, Desai N, Kirtane AJ, Fitzgerald S, Michaels J, Krohn C, Masoudi FA, Brindis RG, Bavaria JE. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2020 Nov 24;76(21):2492-2516. doi: 10.1016/j.jacc.2020.09.595. PMID 33213729
• Attizzani GF, Patel SM, Dangas GD, Szeto WY, Sorajja P, Reardon MJ, Popma JJ, Kodali S, Chenoweth S, Costa MA. Comparison of Local Versus General Anesthesia Following Transfemoral Transcatheter Self-Expanding Aortic Valve Implantation (from the Transcatheter Valve Therapeutics Registry). Am J Cardiol. 2019 Feb 1;123(3):419-425. doi: 10.1016/j.amjcard.2018.10.041. Epub 2018 Nov 6. PMID 30527797
• Abramowitz Y, Vemulapalli S, Chakravarty T, Li Z, Kapadia S, Holmes D, Matsouaka RA, Wang A, Cheng W, Forrester JS, Smalling R, Thourani V, Mack M, Leon M, Makkar RR. Clinical Impact of Diabetes Mellitus on Outcomes After Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Circ Cardiovasc Interv PMID 29138245
• Fanaroff AC, Manandhar P, Holmes DR, Cohen DJ, Harrison JK, Hughes GC, Thourani VH, Mack MJ, Sherwood MW, Jones WS, Vemulapalli S. Peripheral Artery Disease and Transcatheter Aortic Valve Replacement Outcomes: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Therapy Registry. Circ Cardiovasc Interv. 2017 Oct;10(10):e005456. doi: 10.1161/CIRCINTERVENTIONS. PMID 29042398
• Carroll JD, Vemulapalli S, Dai D, Matsouaka R, Blackstone E, Edwards F, Masoudi FA, Mack M, Peterson ED, Holmes D, Rumsfeld JS, Tuzcu EM, Grover F. Procedural Experience for Transcatheter Aortic Valve Replacement and Relation to Outcomes: The STS/ACC TVT Registry. J Am Coll Cardiol. 2017 Jul 4;70(1):29-41. doi: 10.1016/j.jacc.2017.04.056. PMID 28662805
• Alfredsson J, Stebbins A, Brennan JM, Matsouaka R, Afilalo J, Peterson ED, Vemulapalli S, Rumsfeld JS, Shahian D, Mack MJ, Alexander KP. Gait Speed Predicts 30-Day Mortality After Transcatheter Aortic Valve Replacement: Results From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Circulation. 2016 Apr 5;133(14):1351-9. doi: 10.1161/CIRCULATIONA PMID 26920495

Идентификаторы

NCT: NCT01737528 · TVTR-2012-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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