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

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  • References (24)
  • Cited By (2)
Neil E. Moat5
Estimated H-index: 5
(National Health Service),
Peter Ludman4
Estimated H-index: 4
(University Hospitals Birmingham NHS Foundation Trust),
Mark A. de Belder29
Estimated H-index: 29
(James Cook University Hospital)
... more
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 ...
703 Citations Download PDF Cite
Leonor Varela-Lema4
Estimated H-index: 4
,
Alberto Ruano-Ravina18
Estimated H-index: 18
(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
Anna Sonia Petronio33
Estimated H-index: 33
(University of Pisa),
Marco De Carlo33
Estimated H-index: 33
,
Francesco Bedogni35
Estimated H-index: 35
... more
Background—Transcatheter aortic valve implantation (TAVI) is a new option for patients with severe aortic stenosis at high surgical risk. The standard retrograde approach through the femoral artery is contraindicated in case of unfavorable iliofemoral anatomy or extensive disease. In these patients, a trans-subclavian approach may be feasible. Methods and Results—Between June 2007 and July 2009, TAVI with the CoreValve bioprosthesis (Medtronic, Minneapolis, Minn) was performed in 514 consecutive...
212 Citations Download PDF Cite
2013 in Eurointervention [IF: 4.42]
Carlo Di Mario78
Estimated H-index: 78
(Imperial College London),
Hélène Eltchaninoff35
Estimated H-index: 35
,
Neil Moat26
Estimated H-index: 26
(Imperial College London)
... more
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...
125 Citations Source Cite
2010 in Circulation [IF: 18.88]
Martyn Thomas36
Estimated H-index: 36
,
Gerhard Schymik17
Estimated H-index: 17
,
Thomas Walther69
Estimated H-index: 69
... more
Background— Transcatheter aortic valve implantation was developed to mitigate the mortality and morbidity associated with high-risk traditional aortic valve replacement. The Edwards SAPIEN valve was approved for transcatheter aortic valve implantation transfemoral delivery in the European Union in November 2007 and for transapical delivery in January 2008. Methods and Results— The SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry was designed to assess the initial clinical results o...
725 Citations Source Cite
1999 in JAMA [IF: 47.66]
John M. Eisenberg36
Estimated H-index: 36
SOON AFTERRENELAENNEC INVENTED THE STETHOSCOPE in1816, itwasmetwith“suspicionanddistrust . . . by those who were practicing medicine when it was introduced.” As late as the 1850s, skeptics described the new diagnostic aid as “a dangerous instrument.” While most agree that health care technology has advanced physicians’ ability to improve their patients’ health and quality of life, there has been considerable disagreement about which technologies to use, how much is too much, and whether the tech...
77 Citations Source Cite
2011 in European Heart Journal [IF: 23.43]
Martin B. Leon135
Estimated H-index: 135
(Columbia University Medical Center),
Nicolo Piazza40
Estimated H-index: 40
(Columbia University Medical Center),
Eugenia Nikolsky43
Estimated H-index: 43
(Columbia University Medical Center)
... more
Objectives To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical research and to enable meaningful comparisons between clinical trials. To make these consensus definitions accessible to all stakeholders in TAVI clinical research through a peer reviewed publication, on behalf of the public health. Background Transcatheter aortic valve implantation may provide ...
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2011 in JAMA [IF: 47.66]
Sana M. Al-Khatib49
Estimated H-index: 49
(Duke University),
Anne S. Hellkamp43
Estimated H-index: 43
,
Jeptha P. Curtis52
Estimated H-index: 52
... more
Context Practice guidelines do not recommend use of an implantable cardioverter-defibrillator (ICD) for primary prevention in patients recovering from a myocardial infarction or coronary artery bypass graft surgery and those with severe heart failure symptoms or a recent diagnosis of heart failure. Objective To determine the number, characteristics, and in-hospital outcomes of patients who receive a non–evidence-based ICD and examine the distribution of these implants by site, physician specialt...
186 Citations Download PDF Cite
Stephan Haussig6
Estimated H-index: 6
(Leipzig University),
Gerhard Schuler95
Estimated H-index: 95
(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
  • References (24)
  • Cited By (2)
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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