The MANTRA study: a new umbrella concept prospectively applied to assess implantable medical devices for heart valve procedures (original) (raw)
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Open heart, 2016
The future promises many technological advances in the field of heart valve interventions, like tissue-engineered heart valves (TEHV). Prior to introduction in clinical practice, it is essential to perform early health technology assessment. We aim to develop a conceptual model (CM) that can be used to investigate the performance and costs requirements for TEHV to become cost-effective. After scoping the decision problem, a workgroup developed the draft CM based on clinical guidelines. This model was compared with existing models for cost-effectiveness of heart valve interventions, identified by systematic literature search. Next, it was discussed with a Delphi panel of cardiothoracic surgeons, cardiologists and a biomedical scientist (n=10). The CM starts with the valve implantation. If patients survive the intervention, they can remain alive without complications, die from non-valve-related causes or experience a valve-related event. The events are separated in early and late even...
Scientific Reports
Transcatheter aortic valve implantation (TAVI) for aortic stenosis is becoming an appealing alternative to surgical aortic valve replacement in high-risk patients and to medical therapy for inoperable ones. Several new-generation TAVI devices have been recently introduced, but comparative analyses are lacking. We aimed to compare 1-month outcomes associated with such five leading new-generation TAVI devices exploiting data collected in the prospective observational RISPEVA (Registro Italiano GISE sull’impianto di Valvola Aortica Percutanea) Study. We queried the dataset of the ongoing RISPEVA study to retrieve baseline, procedural and 1-month outcome details of patients undergoing TAVI with Acurate, Evolut, Portico, Lotus, and Sapien3. Analysis was based on unadjusted and propensity score-adjusted methods. We included 1976 patients, 234 (11.8%) treated with Acurate, 703 (35.6%) with Evolut, 151 (7.6%) with Lotus, 347 (17.6%) with Portico, and 541 (27.4%) with Sapien3. Unadjusted ana...
Cardiac implant registries 2006–2016: a systematic review and summary of global experiences
BMJ Open
Objectives The importance of Cardiac Implant Registry (CIR) for ensuring a long-term follow-up in postmarket surveillance has been recognised and approved, but there is lack of consensus standards on how to establish a CIR. The aim of this study is to investigate the structure and key elements of CIRs in the past decade (2006-2016) and to provide recommendations on 'best practice' approaches. settings and participants A systematic search on CIR was employed in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The following databases were searched: the PubMed (Medline), ScienceDirect and the Scopus database, EMBASE. After identifying the existing CIRs, an aggregative approach will be used to explore key elements emerging in the identified registries. results The following 82 registries were identified: 18 implantable cardioverterdefibrillator (ICD) registries, 7 cardiac resynchronisation therapy (CRT) registries, 5 pacemaker registries and 6 cardiovascular implantable electronic device registries which combined ICD, pacemaker and CRT implantation data; as well as 22 coronary stent registries and 24 transcatheteraortic heart valve implantation registries. While 71 national or local registries are from a single country, 44 are from European countries and 9 are located in USA. The following criteria have been summarised from the identified registries, including: registry working group, ethic issues, transparency, research objective, inclusion criteria, compulsory participation, endpoint, sample size, data collection basement, data collection methods, data entry, data validation and statistical analysis. Conclusions Registries provide a 'real-world' picture for patients, physicians, manufacturers, payers, decisionmakers and other stakeholders. CIRs are important for regulatory decisions concerning the safety and therefore approval issues of the medical device; for payers CIRs provide evidence on the medical device benefit and drive the decision whether the product should be reimbursed or not; for hospitals CIRs' data are important for sound procurement decisions, and CIRs also help patients and their physicians to joint decision-making which of the products is the most appropriate. Contributors PLK-R provided substantial contributions to conception and design; SZ drafted the articles with acquisition of data, analysis and interpretation of data;
Transcatheter valve therapy registry is a model for medical device innovation and surveillance
Health affairs (Project Hope), 2015
Heart valve diseases are increasingly prevalent, especially in people older than age seventy. Many of these elderly people have other comorbid conditions, making them poor candidates for surgical treatment of heart valve diseases. Since 2011 such patients have been eligible to receive new nonsurgical heart valve treatments approved by the Food and Drug Administration (FDA) and covered by Medicare. This article examines the Transcatheter Valve Therapy Registry, which captures clinical information on all US patients undergoing new nonsurgical heart valve treatments. The registry has patient-level data from more than 27,000 patients treated with the novel devices. Patient- and procedure-related data are gathered from hospitals, patient-reported outcomes are assessed pre- and postprocedure, and longer-term data on mortality and repeat hospitalization are provided by linking the registry's data to Medicare patient data. The registry is a model of collaboration among professional soci...
Trials, 2013
Background: Degenerative aortic valve (AV) stenosis is the most prevalent heart valve disease in the western world. Surgical aortic valve replacement (SAVR) has until recently been the standard of treatment for patients with severe AV stenosis. Whether transcatheter aortic valve implantation (TAVI) can be offered with improved safety and similar effectiveness in a population including low-risk patients has yet to be examined in a randomised setting. Methods/Design: This randomised clinical trial will evaluate the benefits and risks of TAVI using the transarterial CoreValve System (Medtronic Inc., Minneapolis, MN, USA) (intervention group) compared with SAVR (control group) in patients with severe degenerative AV stenosis. Randomisation ratio is 1:1, enrolling a total of 280 patients aged 70 years or older without significant coronary artery disease and with a low, moderate, or high surgical risk profile. Trial outcomes include a primary composite outcome of myocardial infarction, stroke, or all-cause mortality within the first year after intervention (expected rates 5% for TAVI, 15% for SAVR). Exploratory safety outcomes include procedure complications, valve re-intervention, and cardiovascular death, as well as cardiac, cerebral, pulmonary, renal, and vascular complications. Exploratory efficacy outcomes include New York Heart Association functional status, quality of life, and valve prosthesis and cardiac performance. Enrolment began in December 2009, and 269 patients have been enrolled up to December 2012.
PP17 Comprehensive Evaluation Of A Technology With Expanding Indications
International Journal of Technology Assessment in Health Care
Introduction:The use of transcatheter aortic valve implantation (TAVI) is evolving. Our Cardiovascular Evaluation Unit is implementing a comprehensive approach to inform decision-makers on optimal use of TAVI, including the development of quality standards. We are implementing a multifaceted evaluation framework in collaboration with clinical stakeholders.Methods:Our unit has carried out a continuous field evaluation in collaboration with the clinical teams at all six TAVI centers in Québec for the past four years (1 April 2013–31 March 2017), with regular feedback to the teams and sharing of results with each individual center. Hospital documentation was reviewed according to established national quality indicator definitions. Field evaluation data were combined with the results of systematic literature review to establish provincial standards for practice, through a deliberation process by an interdisciplinary committee of clinical experts from each center. Systematic surveillance...
Health technology assessment process of a cardiovascular medical device in four different settings
Journal of comparative effectiveness research, 2017
Health technology assessment (HTA) is a tool to help the decision-making process. The aim is to describe methods and processes used in the reimbursement decision making for drug-eluting stents (DES) in four different settings. DES as a technology under study was selected according to different criteria, all of them agreed by a working group. A survey of key informants was designed. DES was evaluated following well-structured HTA processes. Nonetheless, scope for improvement was observed in relation to the data considered for the final decision, the transparency and inclusiveness of the process as well as in the methods employed. An attempt to describe the HTA processes of a well-known medical device.