Conduction disorders following transcatheter aortic valve replacement using acurate Neo2 transcatheter heart valve: A propensity matched analysis.

BACKGROUND: The ACURATE neo2 transcatheter aortic valve was developed to improve paravalvular leak (PVL) rates while maintaining low rates of conduction disturbances and permanent pacemaker implantation (PPMI) seen with its predecessor. We aimed to compare conduction disturbances rates of transcatheter aortic valve replacement (TAVR) using ACURATE Neo2 with other commonly used valves. METHODS: A retrospective analysis of the Israeli TAVR registry between the years 2014-2023 was performed to compare conduction disturbances and PVL rates, and procedural outcomes, among patients treated with ACURATE neo2, Edwards Sapien 3 (S3), and Evolut PRO valves. Propensity score matching was performed to compare groups with similar characteristics. RESULTS: Following exclusion of patients with non-femoral access, unknown valve type, older-generation valves, and less commonly used valves or (n = 4387), our analysis included 3208 patients undergoing TAVR using ACURATE neo2, Edwards S3, and Evolut PRO valves. Propensity matched groups comprised 169 patients each. Rates of any conduction disturbances [left bundle branch block (LBBB), atrioventricular block, or PPMI] were lower in the ACURATE neo2 group compared to both other valves [15.8 %, S3-37.5 % (p < 0.001), Evolut PRO-27.5 % (p = 0.02)] as were LBBB rates [9.0 %, S3-31.3 % (p < 0.001); Evolut PRO-20.1 % (p = 0.01). Atrioventricular block and PPMI rates were lower without statistical significance, as were rates of above-moderate PVL. CONCLUSIONS: In this analysis, TAVR using ACURATE neo2 was associated with a lower composite rate of conduction disturbances in comparison to the Evolut PRO and Edwards S3 valves, mainly due to lower left bundle branch block rates, with non-significantly lower rates of PPMI and PVL.

Generational Differences in Outcomes of Self-Expanding Valves for Transcatheter Aortic Valve Replacement.

BACKGROUND: The Medtronic Evolut Pro valve (EPV) is a new-generation self-expanding valve (SEV), particularly designed to reduce paravalvular leak (PVL) rates in transcatheter aortic valve replacement (TAVR). We aimed to compare the safety and efficacy of EPV with older-generation SEVs, in particular, postprocedural PVL and permanent pacemaker (PPM) implantation rates. METHODS: We performed a retrospective, multicenter, propensity-matched analysis of the Israeli TAVR registry between September 2008 and June 2019. Two independent propensity score-matched comparisons were performed comparing EPV with the first-generation CoreValve (CV), and comparing EPV with the second-generation Evolut R valve (ERV). RESULTS: The registry included 2591 patients who were propensity-matched into 3 cohorts: EPV (n = 222), CV (n = 212), and ERV (n = 213). Moderate and above PVL rates were lower for EPV (angiographic PVL [aPVL], 0.6%; echocardiographic PVL [ePVL], 3.0%) as compared with CV (aPVL, 7.8% [P<.001] and ePVL, 11.6% [P<.01]), but not as compared with ERV (aPVL, 6.4% [P<.01] and ePVL, 4.4% [P=.57]). Lower rates of PPM were noted for EPV (16.3%) as compared with both CV (33.5%; P<.001) and ERV (24.4%; hazard ratio, 0.61; 95% confidence interval, 0.37-0.995; P=.046). Other safety and efficacy outcome rates were excellent, with significant improvements as compared with older-generation SEVs. CONCLUSIONS: The EPV demonstrates excellent procedural safety and efficacy outcomes. Moderate and above PVL rates were significantly reduced in comparison with CV; however, not significantly reduced as compared with ERV. The need for PPM implantation was lower as compared with both older-generation valves.

Temporal Trends in Gender-Related Differences and Outcomes in Patients Who Underwent Transcatheter Aortic Valve Implantation (from the Israeli Transcatheter Aortic Valve Implantation Multicenter Registry).

We evaluated temporal trends in gender-related differences in patients who underwent transcatheter aortic valve implantation (TAVI) for severe symptomatic aortic stenosis from a multicenter TAVI registry during the years 2008 to 2016. Our final cohort included 1,159 males and 1,370 females, with a median follow-up of 2.3 (IQR 1.2, 4.4) years. For temporal trends analysis, the entire population was divided according to period of procedure: 2008 to 2012 and 2013 to 2016. During the 2008 to 2012 period, the rates of in-hospital aortic paravalvular leak, myocardial infarction, pacemaker implantation, and stroke were higher among men than women, but became comparable between the gender during the 2013 to 2016 period. Multivariate analysis demonstrated that female patients who underwent TAVI between the years 2008 and 2012 had a 26% lower risk of death compared with male patients (p = 0.004), but there were no gender-related differences in mortality risk between the years 2013 and 2016 (hazard ratio 1.07, p = 0.6; gender-by-year of procedure, p = 0.027 for interaction). In conclusion, the favorable long-term prognosis described in female patients during the earlier TAVI period seemed to diminish with contemporary TAVI. This might be attributed to current technological advances and improved valve sizing, with a more significant benefit in favor of male patients.

Pacemaker implantation after transcatheter aortic valve implantation.

Thirty- to 35% of patients after transcatheter aortic valve implantation undergo implantation of a permanent pacemaker (PPM) because of development of atrioventricular block (AVB) or development of a condition with high risk of progression to AVB. There are insufficient data regarding long-term follow-up on pacing dependency. From February 2009 to July 2011, 191 transcatheter aortic valve implantation procedures were performed at the Rabin Medical Center (125 CoreValve and 66 Edwards SAPIEN). Thirty-two patients (16.7%) received a PPM (30 with CoreValve and 2 with Edwards SAPIEN). Data from the pacemaker clinic follow-up was available in 27 patients. After a mean follow-up of 52 weeks (range, 22 to 103), only 8 (29%) of 27 patients were pacing dependent. The indication of PPM in these 8 patients was complete AVB. In conclusion, in our center, the rate of PPM implantation was 16%, which is lower than that reported in the published works. Only 29% of those patients implanted with PPM were pacemaker dependent. Further studies are necessary to define reliable predictors for long-term pacing.

Percutaneous aortic valve implantation: early clinical experience and future perspectives.

The incidence of aortic valve stenosis is growing rapidly in the elderly. Nonetheless, many symptomatic patients are not referred for surgery usually because of high surgical risk. Unfortunately, percutaneous balloon valvuloplasty is unsatisfactory due to high recurrence rates. In 2002, Cribier and colleagues were the first to describe percutaneous aortic valve implantation in a patient, opening a new era of aortic stenosis management. In the present review we report a patient treated by this novel method, discuss and assess how it is implanated, report the findings of studies conducted to date, and suggest future directions for percutaneous treatment of aortic valve disease.

Acute and intermediate-term results of percutaneus left main coronary artery interventions.

BACKGROUND: Left main coronary artery disease is considered a surgical indication in most centers. However, in some cases prohibited from surgery or in patients with prior bypass grafting, there is a need for percutaneous coronary intervention in LMCA disease scenarios. OBJECTIVES: To assess the clinical outcomes among patients undergoing stent-based LMCA angioplasty. METHODS: We identified 34 consecutive patients who underwent PCI in LMCA at our institution. Procedural data and clinical outcomes were obtained for all patients. RESULTS: The mean age was 71 +/- 12 years. There were 27 elective and 7 emergent procedures performed on 23 "protected" LMCA and 11 "unprotected" LMCA. In emergent procedures, the prevalence of cardiogenic shock (29% vs. 0%, P = 0.04) in patients with prior coronary bypass (29% vs. 8.5%, P = 0.007) was significantly higher compared to elective cases. Procedural success in emergent procedures was significantly lower than in elective procedures (71 vs. 100%, P = 0.04). In emergent versus elective procedures, the in-hospital mortality rate was higher (43 vs. 0%, P = 0.006). The rate of cumulative major adverse cardiac events at 1 and 6 months was 43% and 71% in emergent cases versus 0% and 33% in elective cases (P < 0.05 for both comparisons). In patients with "unprotected" LMCA the overall rate of major cardiac events at 1 month was higher compared to "protected" LMCA patients (27 vs. 0%, P = 0.02). Multivariate analysis revealed emergent procedure as an independent predictor for mortality and adverse cardiac events (odds ratio 6.7, 95% confidence interval 1.2-36; P = 0.02). CONCLUSIONS: Percutaneous interventions in LMCA are feasible and relatively safe in carefully selected cases. Procedural outcomes and clinical prognosis is highly dependent on the nature of disease prior to angioplasty (e.g., elective vs. emergent procedure) as well as on protection of the LMCA by patent grafts.