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Post-introduction observation of transcatheter aortic valve implantation in Galicia (Spain).

Published on Feb 1, 2015in Journal of Evaluation in Clinical Practice 1.54
· DOI :10.1111/jep.12225
Leonor Varela-Lema5
Estimated H-index: 5
,
Teresa Queiro-Verdes1
Estimated H-index: 1
+ 12 AuthorsMarisa López-García2
Estimated H-index: 2
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Abstract
Rationale, aims and objectives Transcatheter aortic valve implantation constitutes an example of a technology introduced into the Galician Health Care System basket and subjected to a post-introduction observational study after coverage. This paper aims to describe the process and results of this experience, illustrating the main challenges and opportunities in using these studies for supporting decision making. Methods The study protocol was developed by a multidisciplinary team consisting of experts from the Galician HTA Agency (avalia-t), interventional cardiologists and cardiac surgeons. Together they agreed on the information that was relevant and feasible for collection, and planned the study design, data collection and analysis of results. Results During the 1-year recruitment period, 94 patients underwent percutaneous aortic valve replacement in the three authorized centres. Implantation rate and prosthesis models differed substantially across the centres. Overall, procedural success rate was 96.8% and hospital mortality was 7.4%. Complications during post-surgical admission were recorded in 40.4% of patients. Moderate residual aortic regurgitation was observed in 10% of patients, and the procedure was associated with a stroke rate of 3.3% at 30 days and 5.3% at 1 year. Conclusions Post-introduction observation has made it feasible to determine the use of this procedure within the SERGAS context and has enabled the assessment of performance in real-life conditions. The proposed strategic actions and interventions have been drawn up based upon the collective judgement of a group of experienced professionals, and have served to establish recommendations on further research that would be required to optimize health benefits.
  • References (24)
  • Citations (2)
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References24
Newest
Published on Aug 1, 2014in Clinical Research in Cardiology 4.91
Stephan Haussig6
Estimated H-index: 6
(Leipzig University),
Gerhard Schuler97
Estimated H-index: 97
(Leipzig University),
Axel Linke60
Estimated H-index: 60
(Leipzig University)
With a rapidly aging society, the number of patients with cardiovascular disease—in particular aortic stenosis—is progressively increasing. Although conventional aortic valve replacement remains the only treatment known to improve prognosis and symptoms in symptomatic patients with aortic stenosis, about one-third are still withhold from the life-saving therapy. Based on the compelling evidence of the randomized Placement of Aortic transcatheter valves (PARTNER) A and B cohort, TAVI is now consi...
31 Citations Source Cite
Published on Apr 1, 2013in Eurointervention 4.02
Carlo Di Mario82
Estimated H-index: 82
(Imperial College London),
Hélène Eltchaninoff42
Estimated H-index: 42
+ 26 AuthorsEduardo Alegria Barrero6
Estimated H-index: 6
(Imperial College London)
Aims: The aim of this prospective multinational registry is to assess and identify predictors of in-hospital outcome and complications of contemporary TAVI practice. Methods and results: The Transcatheter Valve Treatment Sentinel Pilot Registry is a prospective independent consecutive collection of individual patient data entered into a web-based case record form (CRF) or transferred from compatible national registries. A total of 4,571 patients underwent TAVI between January 2011 and May 2012 i...
126 Citations Source Cite
Published on Jan 1, 2013in Annals of Internal Medicine 19.32
Prateek J. Khatri1
Estimated H-index: 1
,
John G. Webb98
Estimated H-index: 98
+ 6 AuthorsDennis T. Ko42
Estimated H-index: 42
148 Citations Source Cite
Published on Dec 13, 2012in The New England Journal of Medicine 70.67
Arthur J. Moss109
Estimated H-index: 109
(UR: University of Rochester),
Claudio Schuger27
Estimated H-index: 27
+ 13 AuthorsJosef Kautzner44
Estimated H-index: 44
We randomly assigned 1500 patients with a primary-prevention indication to receive an ICD with one of three programming configurations. The primary objective was to determine whether programmed high-rate therapy (with a 2.5-second delay before the initiation of therapy at a heart rate of ≥200 beats per minute) or delayed therapy (with a 60-second delay at 170 to 199 beats per minute, a 12-second delay at 200 to 249 beats per minute, and a 2.5-second delay at ≥250 beats per minute) was associ ate...
735 Citations Source Cite
Published on Dec 1, 2012in Journal of Evaluation in Clinical Practice 1.54
Leonor Varela-Lema5
Estimated H-index: 5
,
Alberto Ruano-Ravina23
Estimated H-index: 23
(University of Santiago de Compostela),
Teresa Cerdá Mota2
Estimated H-index: 2
Rationale, aims and objectives Early assessment of health technologies after they are covered by the health system is deemed crucial to promptly identify and analyse unforeseen problems that may arise when these are used in real world settings. This paper aims to describe the various instruments which could be used for collecting information intended for prospective observation of health technologies, so as to choose the specific instrument best suited to each context. Methods Systematic review ...
2 Citations Source Cite
Published on Sep 1, 2012in European Journal of Cardio-Thoracic Surgery 3.85
Augusto D'Onofrio14
Estimated H-index: 14
(UNIPD: University of Padua),
Paolo Rubino3
Estimated H-index: 3
+ 4 AuthorsGino Gerosa40
Estimated H-index: 40
(UNIPD: University of Padua)
OBJECTIVES: Redo cardiac surgery has an increased risk of morbidity and mortality when compared with the initial operation. The aim of this study was to assess the impact of previous cardiac operations on patients undergoing transapical aortic valve implantation (TATAVI). METHODS: We analysed data from 566 patients included in the Italian Registry of Transapical Aortic Valve Implantation who underwent TA-TAVI implantation with the Sapien valve (Edwards Lifesciences, Irvine, CA, USA) from April 2...
24 Citations Source Cite
Leonor Varela-Lema5
Estimated H-index: 5
,
Alberto Ruano-Ravina23
Estimated H-index: 23
(University of Santiago de Compostela)
+ 6 AuthorsLaura Sampietro-Colom13
Estimated H-index: 13
Objectives: When a new health technology has been approved by a health system, it is difficult to guarantee that it is going to be efficiently adopted, adequately used, and that effectiveness, safety, and consumption of resources and costs are in line with what was expected in preliminary investigations. Many governmental institutions promote the idea that efficient mechanisms should be established aimed at developing and incorporating continuous evidence into health technologies management. The...
4 Citations Source Cite
Published on May 3, 2012in The New England Journal of Medicine 70.67
Martine Gilard44
Estimated H-index: 44
,
Hélène Eltchaninoff42
Estimated H-index: 42
+ 38 AuthorsAlain Prat26
Estimated H-index: 26
Background Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses. We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2. Methods All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause. Results A total...
882 Citations Source Cite
Published on Nov 1, 2011in Journal of the American College of Cardiology 18.64
Neil Moat30
Estimated H-index: 30
(National Health Service),
Peter Ludman6
Estimated H-index: 6
(University Hospitals Birmingham NHS Foundation Trust)
+ 18 AuthorsPhilip MacCarthy35
Estimated H-index: 35
(University of Cambridge)
Objectives The objective was to define the characteristics of a real-world patient population treated with transcatheter aortic valve implantation (TAVI), regardless of technology or access route, and to evaluate their clinical outcome over the mid to long term. Background Although a substantial body of data exists in relation to early clinical outcomes after TAVI, there are few data on outcomes beyond 1 year in any notable number of patients. Methods The U.K. TAVI (United Kingdom Transcatheter ...
716 Citations Source Cite
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Published on Dec 1, 2014in Journal of Thoracic Disease 2.03
Background: Transcatheter aortic valve implantation (TAVI) has been developed recently for patients with high morbidities and who are believed to be not tolerate standard surgical aortic valve replacement. Nevertheless, the TAVI is associated with complications such as potential obstruction of coronary ostia, mitral valve insufficiency, and stent migration although it seems promising. Impairment of the coronary blood flow after TAVI is catastrophic and it was believed to be associated with the c...
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