Cheung, Anson

Introduction: Aortic valve replacement approaches have shifted towards catheter-based therapies in older patients. While this strategy is appropriate in extreme risk cases, concerns regarding aortic insufficiency(AI)/paravalvular leak and stroke with catheter valves may favor use of surgical aortic valve replacement in intermediate and low risk patients. We present outcomes of intermediate risk octogenarian patients undergoing surgical aortic valve replacement enrolled in a prospective trial with robust endpoint assessment and follow-up. Methods: The St. Jude Trifecta IDE trial was a prospective approval study for a new aortic valve prosthesis. The Trifecta bioprosthesis was implanted in 210 pts over 80 years of age between 2007 and 2009 at 28 centers in the US, Canada, and Europe. Mean age was 83.5 ± 2.7 years(range 80-95) of which 103[49.0%] were female. 62[29.5%] subjects had undergone previous cardiac surgery. Concomitant CABG was performed in 103 [49.0%] patients. Results: The mean STS predicted mortality score was 4.02 +/- 2.16. Follow-up was 399.4 late patient-years. Early (≤ 30 day) mortality occurred in 3 [1.4%] patients and there were 17 late (≥ 31 days) deaths yielding a survival of 91.7% at 2 years and 87.1% at 3 years. There was no paravalvular leak, valve thrombosis, early endocarditis or hemolysis. There were 7 early neurologic events including 2 [1.0%] strokes, and 5 [2.4%] reversible neurologic events. There were 9 late thromboembolic events, including 3 strokes and 6 reversible neurologic events or transient ischemic attacks (linearized rate 2.25%/year of follow-up). Freedom from valve explant was 99.4% at 3 years. Mean gradient and effective orifice area at 3 year follow-up was 10.2 mmHg +/- 5.0 and 1.43 cm2 +/- 0.26, respectively. 88.9% of patients demonstrated none or trivial AI, 2.2% and 0% demonstrated moderate and severe AI, respectively. Conclusions: In conclusion, surgical valve replacement in elderly intermediate risk patients demonstrates superb clinical outcomes and results. Extremely low rates of stroke and aortic insufficiency in combination with excellent 3-4 year survival show a favorable profile for intermediate risk patients to undergo surgical aortic valve replacement.

Background: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. Methods: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate. Results: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76–996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510–1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR ( P <0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients ( P =0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P <0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P =0.02). The rates of Mitral Valve Academic Research Consortium–defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P =0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74–12.56; P =0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88–21.53; P <0.001) were both independently associated with repeat mitral valve replacement. Conclusions: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.

De novo progressive aortic insufficiency (AI) is a side effect frequently related to prolonged support with continuous-flow left ventricular assist devices (CF-LVAD). Its progression can result in recurrent clinical heart failure symptoms and significantly increased mortality. Recently, percutaneous intervention methods, such as transcatheter aortic valve replacement (TAVR) and percutaneous occluder devices, have emerged. However, given the very scarce global experience with these approaches, evidence in the literature is lacking. We sought to assess the outcomes of CF-LVAD patients who had undergone percutaneous intervention for AI. A systematic search of six databases from inception to April 2016 was performed by two independent reviewers. Eligible studies were those that included series or cases where patients had percutaneous transcatheter interventions for AI in CF-LVAD patients. Data were extracted and meta-analyzed from the identified studies. A total of 29 patients from 15 published studies and 3 unpublished records were included in the analysis. Mean patient age was 56.6 ± 13.7 years, and 72.4% were male. The etiology of heart failure resulting in LVAD placement was ischemic cardiomyopathy in 17.2%. The two intervention groups were TAVR (27.6%) and occluder devices (72.4%). A transfemoral approach (69%), apical approach (10%), brachial approach (7%), subclavian approach (3%), and mini-sternotomy (3%) were used. The preintervention AI grade was severe with a median grade of 4 (interquartile range, 4–4). Postoperatively, the AI grade improved significantly to a median grade of 0 (0–2). At long-term follow-up AI grade was still trivial with a median AI grade of 1 (0–1). Subgrouping the treatments into the occluder device and TAVR, it was found that both interventional techniques were similarly effective in reducing the AI grade from severe to trivial. In terms of complications, from the occluder group, two patients were complicated with device migration and another two with transient hemolysis. In the TAVR cohort, two patients experienced device migration and another had significant postimplant perivalvular leakage. Our results indicate that percutaneous interventions for AI in CF-LVAD patients with TAVR, and closure devices demonstrate similar efficacy in significantly reducing severe AI. Current results are encouraging, potentiating viability as a treatment option, particularly in nonsurgical candidates. Future research with larger patient cohorts and comparative controls is required to sufficiently evaluate the efficacy of this technique and promote its widespread acceptance as a mainstay treatment.