Background: Transcatheter mitral valve replacement using aortic transcatheter heart valves has recently become an alternative for patients with degenerated mitral bioprostheses, failed surgical repairs with annuloplasty rings or severe mitral annular calcification who are poor surgical candidates. Outcomes of these procedures are collected in the Society of Thoracic Surgeons/American College of Cardiology/Transcatheter Valve Therapy Registry. A comprehensive analysis of mitral valve-in-valve (MViV), mitral valve-in-ring (MViR), and valve-in-mitral annular calcification (ViMAC) outcomes has not been performed. We sought to evaluate short-term outcomes of early experience with MViV, MViR, and ViMAC in the United States. Methods: Retrospective analysis of data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Results: Nine hundred three high-risk patients (median Society of Thoracic Surgeons score 10%) underwent MViV (n=680), MViR (n=123), or ViMAC (n=100) between March 2013 and June 2017 at 172 hospitals. Median age was 75 years, 59.2% female. Technical and procedural success were higher in MViV. Left ventricular outflow tract obstruction occurred more frequently with ViMAC (ViMAC=10%, MViR=4.9%, MViV=0.7%; P <0.001). In-hospital mortality (MViV=6.3%, MViR=9%, ViMAC=18%; P =0.004) and 30-day mortality (MViV=8.1%, MViR=11.5%, ViMAC=21.8%; P =0.003) were higher in ViMAC. At 30-day follow-up, median mean mitral valve gradient was 7 mm Hg, most patients (96.7%) had mitral regurgitation grade ≤1 (+) and were in New York Heart Association class I to II (81.7%). Conclusions: MViV using aortic balloon-expandable transcatheter heart valves is associated with a low complication rate, a 30-day mortality lower than predicted by the Society of Thoracic Surgeons score, and superior short-term outcomes than MViR and ViMAC. At 30 days, patients in all groups experienced improvement of symptoms, and valve performance remained stable. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02245763.
BackgroundPatients with severe aortic stenosis (AS) at high risk for aortic valve replacement are a unique population with multiple treatment options, including medical therapy, surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR). Traditionally, in elderly populations, goals of treatment may favour quality of life over survival. Professional guidelines recommend that clinicians engage patients in shared decision making, a process that may lead to decisions more aligned with patient‐defined goals of care. Goals of care for high‐risk patients with AS are not well defined in the literature, and patient‐reported barriers to shared decision making highlight the need for explicit encouragement from clinicians for patient involvement.ObjectiveThe purpose of this study was to elicit and report patient‐defined goals from elderly patients facing treatment decisions for severe AS.MethodsThis analysis was conducted at Dartmouth‐Hitchcock Medical Center, an academic medical institution. In a retrospective manner, we qualitatively analysed goal statements reported by high‐risk, elderly patients with severe AS evaluated for TAVR between June 2012 and August 2014.ResultsForty‐six patients provided treatment goals during consideration of TAVR and defined preferred outcomes as maintaining independence, staying alive, reducing symptoms or, most commonly, increasing their ability to do a specific activity or hobby.ConclusionsIn the high‐risk patient population considering TAVR, patient‐reported goals may be obtained with a simple question delivered during the clinical encounter. Encouraging patients to define their goals may lead to a greater degree of shared decision making, as advocated in current professional guidelines.
Although it is not clear whether this is primarily because of patient or physician preference, there is consistency in patient misperception of the benefit of PCI. 8 The treatment of stable CAD represents a preferencesensitive decision with comparable, alternative treatments. Shared decision making (SDM), as a "process of interacting with patients who wish to be involved in arriving at an informed, values-based choice among…medically reasonable alternatives," 9 offers a unique approach to healthcare delivery of patients with stable CAD. Decision aids may help Background-Percutaneous coronary intervention (PCI) for stable coronary artery disease does not reduce the risk of death and myocardial infarction compared with optimal medical therapy (OMT), but many patients think otherwise. PCI Choice, a decision aid (DA), was designed for use during the clinical visit and includes information on quality of life and mortality outcomes for PCI with OMT versus OMT alone for stable coronary artery disease. Methods and Results-We conducted a randomized trial to assess the impact of the PCI Choice DA compared with usual care when there is a choice between PCI and optimal medical therapy. Primary outcomes were patient knowledge and decisional conflict, and the secondary outcome was an objective measure of shared decision making. A total of 124 patients were eligible for final analysis. Knowledge was higher among patients receiving the DA compared with usual care (60% DA; 40% usual care; P=0.034), and patients felt more informed (P=0.043). Other measures of decisional quality were not improved, and engagement of the patient by the clinician in shared decision making did not change with use of the DA. There was evidence that clinicians used the DA as an educational tool. Conclusions-The PCI Choice DA improved patient knowledge but did not significantly impact decisional quality. Further work is needed to effectively address clinician knowledge gaps in shared decision-making skills, even in the context of carefully designed DAs. Clinical Trial Registration-URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01771536.(Circ Cardiovasc Qual Outcomes. 2016;9:767-776.
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