Jonathon Leipsic

Regional systems of care to optimize outcomes in patients undergoing transcatheter aortic valve replacement

OBJECTIVESnThis study sought to describe the development of a multicenter, transcatheter aortic valve replacement program and regional systems of care intended to optimize coordinated, efficient, and appropriate delivery of this new therapy.nnnBACKGROUNDnTranscatheter aortic valve replacement (TAVR) has become an accepted treatment option for patients with severe aortic stenosis who are at high surgical risk. Regional systems of care have led to improvements in outcomes for patients undergoing intervention for myocardial infarction, cardiac arrest, and stroke. We implemented a regional system of care for patients undergoing TAVR in British Columbia, Canada.nnnMETHODSnWe describe a prospective observational cohort of 583 patients who underwent TAVR in British Columbia between 2012 and 2014. Regionalization of TAVR care in British Columbia refers to a centrally coordinated, funded, and evaluated program led by a medical director and a multidisciplinary advisory group that oversees planning, access to care, and quality of outcomes at the 4 provincial sites. Risk-stratified case selection for transfemoral TAVR is performed by heart teams at each site on the basis of consensus provincial indications. Referrals for lower volume and more complicated TAVR, including nontransfemoral access and valve-in-valve procedures, are concentrated at a single site. In-hospital and 30-day outcomes are reported.nnnRESULTSnThe median age was 83 years (interquartile range [IQR]: 78 to 87 years) and median STS score was 6% (IQR: 4% to 8%). Transfemoral access was performed in 499 (85.6%) cases and nontransfemoral in 84 (14.4%). Transcatheter valve-in-valve procedures in for failed bioprosthetic valves were performed in 43 patients (7.4%). A balloon-expandable valve was inserted in 386 (66.2%) and a self-expanding valve in 189 (32.4%). All-cause 30-day mortality was 3.5%. All-cause in-hospital mortality and disabling stroke occurred in 3.1% and 1.9%, respectively. Median length of stay was 3 days (IQR: 3 to 6 days), with 92.8% of patients discharged directly home.nnnCONCLUSIONSnThis experience demonstrates the potential benefits of a regional system of care for TAVR. Excellent outcomes were demonstrated: most patients had short in-hospital stays and were discharged directly home.

Trials Testing the Value of Imaging Use in Valve Disease and in Transcatheter Valvular Interventions

The role of imaging in the diagnosis of valvular heart disease is well established through years of investigation and validation. However, the role of imaging in guiding the treatment decision-making for valvular heart disease is less well established, and there is a striking paucity of randomized trial data to help inform these decisions. Given this relative absence of randomized trial data, the present article highlights some of the most important knowledge gaps and defines meaningful opportunities for the field to help advance the care of patients with valvular heart disease in a cost-effective fashion. (The PARTNER 3-Trial: The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [P3]; NCT02675114; Medtronic Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).

Multimodality imaging for transcatheter aortic valve replacement

Multimodality imaging for transcatheter aortic valve replacement / , Multimodality imaging for transcatheter aortic valve replacement / , کتابخانه دیجیتال جندی شاپور اهواز

Use of Imaging Endpoints in Clinical Trials

Cardiovascular imaging is an integral component of many clinical trials beyond those for which the primary goal is to evaluate or validate imaging technologies. The scope of such trials is broad, ranging from those in which a medical, surgical, or interventional cardiovascular device or drug is being evaluated to those in which there is concern about cardiovascular adverse events complicating treatment for noncardiac conditions. This paper discusses study design as itxa0pertains to the incorporation of imaging elements, the important role played by imaging core laboratories, the rationale for and approaches to involvement of imagers in clinical trials, and guidance by the U.S. Food and Drug Administration onxa0imaging endpoints in clinical trials.