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Objectives: To demonstrate safety, feasibility and short-term clinical outcomes after transcatheter aortic valve-in-valve (ViV) implantation under local anesthesia without contrast aortography or echocardiographic guidance., Background: Transcatheter ViV implantation is an emerging treatment modality for patients with degenerative surgical bioprostheses. Given the radiopaque properties of the surgical aortic valve (SAV) frame, ViV procedures can often be performed with fluoroscopic guidance alone., Methods: ViV implantation was performed in 37 patients with SAV failure under local anesthesia without contrast aortography. Clinical and echocardiographic data were obtained at baseline, discharge, and 30 days., Results: Mean age was 74 ± 10 years and STS predicted risk of mortality was 5.6 ± 2.4%. Mean transaortic gradient decreased from 39.4 ± 15.5 mmHg to 13 ± 6.3 mmHg at discharge (p < .001), and 20 ± 7.5 mmHg at 30 days (p < .001 compared to baseline), aortic valve area increased from 0.9 ± 0.3 cm 2 to 1.2 ± 0.4 cm 2 at 30 days (p = .007). No patient had more than mild aortic regurgitation. Hospital discharge occurred at a median of 2.6 ± 4.4 days. At 30-day follow-up there were no deaths, myocardial infarctions, strokes, repeat hospital admissions for heart failure, or renal failure. One patient (2.7%) required a new pacemaker. 93% of the patients were in New York Heart Association functional class I or II., Conclusions: Transcatheter aortic ViV implantation for selected patients with degenerative surgical bioprostheses under local anesthesia without aortography or echocardiographic guidance is feasible and safe., (© 2019 Wiley Periodicals, Inc.)

Objectives: The aim of this study was to compare transcatheter aortic valve replacement (TAVR) with the Acurate neo (NEO) and Evolut PRO (PRO) devices., Background: The NEO and PRO bioprostheses are 2 next-generation self-expanding devices developed for TAVR., Methods: The NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) registry retrospectively included patients who underwent transfemoral TAVR with either NEO or PRO valves at 24 centers between January 2012 and March 2018. One-to-one propensity score matching resulted in 251 pairs. Pre-discharge and 30-day Valve Academic Research Consortium (VARC)-2 defined outcomes were evaluated. Binary logistic regression was performed to adjust the treatment effect for propensity score quintiles., Results: A total of 1,551 patients (n = 1,263 NEO; n = 288 PRO) were included. The mean age was 82 years, and the mean Society of Thoracic Surgeons score was 5.1%. After propensity score matching (n = 502), VARC-2 device success (90.6% vs. 91.6%; p = 0.751) and pre-discharge moderate to severe (II+) paravalvular aortic regurgitation (7.3% vs. 5.7%; p = 0.584) were comparable between the NEO and PRO groups. Furthermore, there were no significant differences in any 30-day clinical outcome between matched NEO and PRO pairs, including all-cause mortality (3.2% vs. 1.2%; p = 0.221), stroke (2.4% vs. 2.8%; p = 1.000), new permanent pacemaker implantation (11.0% vs. 12.8%; p = 0.565), and VARC-2 early safety endpoint (10.6% vs. 10.4%; p = 1.000). Logistic regression on the unmatched cohort confirmed a similar risk of VARC-2 device success, paravalvular aortic regurgitation II+, and 30-day clinical outcomes after NEO and PRO implantation., Conclusions: In this multicenter registry, transfemoral TAVR with the NEO and PRO bioprostheses was associated with high device success, acceptable rates of paravalvular aortic regurgitation II+, and good 30-day clinical outcomes. After adjusting for potential confounders, short-term outcomes were similar between the devices., (Copyright © 2019. Published by Elsevier Inc.)

Background: The use of transcatheter aortic valve replacement (TAVR) is steadily increasing with TAVR procedures offered to patients across the entire spectrum of surgical risks. The Gulf TAVR registry captures the demographics of patients undergoing TAVR in the Gulf region, comorbidities that drive outcomes, procedural success, complications, and one-year outcomes of death or rehospitalization.Methods: This is a retrospective cohort study for adult patients aged at least 18 years undergoing TAVR at eight centers in the Gulf region. The primary outcome was a composite of death or re-hospitalization at one-year. Secondary outcomes included the individual components of the composite, stroke, and myocardial infarction (MI). We used multivariable Cox regression to determine factors associated with the composite endpoint.Results: A total of 795 patients (56% male) were included in the final analysis with a mean age of 74.6 (standard deviation (SD) 8.9) years, Society of Thoracic Surgeons Score (STS) Score 4.9 (4.2), ejection fraction of 53% (12.7%). Transfemoral approach was employed in over 95% (762/795). The primary outcomes rate was 12.8% (95% confidence interval [CI]: 10.6-15.4); secondary endpoints were death 5.4% (95% CI 4.0-7.2); stroke 0.8% (95% CI 0.3, 1.7), MI 0.8% (95% CI 0.4-1.9), rehospitalization: 9.3% (95% CI 7.5-11.5) of whom 71.6% were related to cardiovascular causes. 77% of the cardiovascular admissions were attributable to heart failure or the need for pacemaker implantation. Stage IV or V chronic kidney disease was significantly associated with the primary composite endpoint (Hazard Ratio: 2.49, [95% CI: 1.31, 4.73], p = 0.005). Although not significant, paravalvular leak and severe left ventricular dysfunction showed a 2-fold and 3-fold increased risk for the composite endpoint, respectively.Conclusions: The Gulf TAVR registry is the first of its kind in the region. It profiles an elderly population with a high procedural success rate and a low rate of complications. One-year outcomes were primarily driven by repeat hospitalization for heart failure and pacemaker implantation indicating a need to optimize heart failure management and improve algorithms for the detection of conduction abnormalities. [ABSTRACT FROM AUTHOR]