Article

Multisociety (AATS, ACCF, SCAI, and STS) Expert Consensus Statement: Operator and Institutional Requirements for Transcatheter Valve Repair and Replacement, Part 1: Transcatheter Aortic Valve Replacement

Division of Cardiology, NorthShore University HealthSystem, Skokie Hospital, Skokie, Illinois 60076, USA.
Journal of the American College of Cardiology (Impact Factor: 15.34). 02/2012; 59(22):2028-42.
Source: PubMed
0 Bookmarks
 · 
81 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: Transcatheter aortic valve replacement (TAVR) is performed with increasing frequency in the United States since Food and Drug Administration approval in 2011. The procedure involves the replacement of a severely stenosed native or bioprosthetic aortic valve with a specially constructed valvular prosthesis that is mounted onto a stent, without the use of cardiopulmonary bypass and the complications of a major open surgical procedure. TAVR has been performed mostly in elderly patients with multiple comorbidities or who have undergone previous cardiac surgery. The most commonly used access routes are the femoral artery (transfemoral) or the cardiac apex (transapical), but the transaortic and transubclavian approaches are also used with varying frequency. Conscious sedation may be used in patients undergoing transfemoral TAVR, but the use of general anesthesia has not been shown to carry greater risk and permits the use of transesophageal echocardiography to assist in valve positioning and diagnose complications. Cardiovascular instability during TAVR is relatively common, necessitating invasive monitoring and frequent use of vasoactive medications. Complications of the procedure are still relatively common and the most frequent is vascular injury to the access sites or the aorta. Cardiovascular collapse may be the result of major hemorrhage pericardial effusion with tamponade or coronary occlusion due to incorrect valve placement. Persistent hypotension, myocardial stunning, or injury requiring open surgical intervention may necessitate the use of cardiopulmonary bypass, the facilities for which should always be immediately available. Ongoing and planned trials comparing conventional surgery with TAVR in lower risk and younger patients should determine the place of TAVR in the medium- to long-term future.
    Anesthesia & Analgesia 10/2014; 119(4):784-798. · 3.42 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Assessing the value of health technologies, through health technology assessment is critically dependent on the existence of relevant and robust clinical data on the efficacy, safety and ideally, effectiveness of the technologies concerned. However, in the case of medical devices, such clinical data may not always be available, because of the different nature of the regulatory requirements in different jurisdictions. Therefore, we conducted a systematic review of the regulatory requirements in seven major jurisdictions in order to identify current challenges and to suggest possible improvements. There are differences in the requirements across jurisdictions and in the balance between pre-market and post-market controls. Several improvements are required in order to generate adequate clinical data for health technology assessment.
    Expert Review of Pharmacoeconomics & Outcomes Research 09/2014; · 1.87 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Background: Transcatheter aortic valve replacement (TAVR) is an increasingly available therapy for the management of aortic stenosis in higher risk populations. Beyond addressing the procedural challenges, centers must attend to the unique requirements of developing TAVR programs from referral to follow-up.Aim: The aim of this manuscript is to outline the recommendations for best practice for program development from centers with early and extensive experience.Recommendations: The guideline-recommended Heart Team approach requires interdisciplinary agreements, delineation of roles and responsibilities, and the development of the role of the TAVR Coordinator. To support appropriate case selection, the screening and evaluation must be organized in a comprehensive clinic visit. In addition to the multimodality imaging tests, the assessment of functional status and frailty is pivotal to the eligibility decision. Throughout the TAVR trajectory, careful attention must be afforded to the integration of geriatric best practices. Pre-procedure care requires patient and family education to manage expectations and facilitate early discharge planning. Peri-procedural care planning, including equipment requirements, monitoring protocols and emergency intervention agreements, contributes to procedural success. The aims of post-procedure care are to monitor the recovery, facilitate the rapid return to baseline status, and optimize length of stay. TAVR programs require data management strategies to manage and monitor program growth, support program evaluation, and meet the requirements for submission to national registries.Conclusion: TAVR represents a paradigm shift in the management of structural heart disease. Programmatic success and patient outcomes depend on the development of a comprehensive and collaborative program tailored to TAVR. © 2014 Wiley Periodicals, Inc.
    Catheterization and Cardiovascular Interventions 04/2014; 84(6). · 2.51 Impact Factor