Comparison of outcomes of self-expanding versus balloon-expandable valves for transcatheter aortic valve replacement: a meta-analysis of randomized and propensity-matched studies.

BACKGROUND: The postoperative outcomes of transcatheter aortic valve replacement (TAVR) with the new generation of self-expanding valves (SEV) and balloon-expandable valves (BEV) remain uncertain. METHODS: We conducted a meta-analysis based on randomized controlled trials (RCTs) and propensity score-matched (PSM) studies to evaluate the performance of the new generation TAVR devices, with a focus on Edwards SAPIEN 3/Ultra BEV, Medtronic Evolut R/PRO SEV, and Boston ACURATE neo SEV. Our primary endpoints were mortality and complications at both 30 days and one year post-operation. RESULTS: A total of 4 RCTs and 14 PSM studies were included. Our findings showed no significant difference between SEV and BEV regarding 30-day and 1-year mortality rates. ACURATE SEV required less permanent pacemaker implantation (PPI) at 30-day as compared to SAPIEN BEV, while Evolut SEV required a higher rate of PPI than SAPIEN BEV. The incidence of stroke, major or life-threatening bleeding (MLTB), major vascular complications (MVC), coronary artery obstruction (CAO) and acute kidney injury (AKI) did not differ significantly between the two groups. SEV had a larger effective orifice area (EOA) and lower mean transvalvular gradients (MPG) compared to BEV. However, there was an increased risk of paravalvular leakage (PVL) associated with SEV. CONCLUSIONS: In terms of 30-day mortality, stroke, bleeding, MVC, AKI, CAO, and one-year mortality, there was comparability between the two valve types following TAVR. SEV was associated with better hemodynamic outcomes, except for a higher incidence of PVL. Compared to SAPIEN BEV, ACURATE SEV had a lower risk of PPI at 30 days, while Evolut SEV was associated with a higher risk of PPI. These findings underscore the importance of personalized valve selection.

Balloon-Expandable Pulmonary Valves for Patched or Native Right Ventricular Outflow Tracts.

The implantation of percutaneous balloon expandable valves in native or patched right ventricular outflow tracts (nRVOT) is a challenging technique due to the diversity of anatomies and shapes, the large sizes, and the distensibility of the nRVOT, for which specific techniques have been developed. We present a single center experience with balloon expandable percutaneous pulmonary valves in nRVOT, describing the techniques used, complications observed, and a short-mid term follow-up.. This is a single center descriptive study of patients who underwent a percutaneous pulmonary valve implantation in a nRVOT with a balloon expandable pulmonary valve in our center between September 2012 and June 2022.. We implanted successfully 45 valves in 46 patients (20 Sapien and 25 Melody). Tetralogy of Fallot or pulmonary atresia with VSD were the main congenital heart disease (n = 32). All were pre-stented, 18 in a one step procedure. We used a Dryseal sheath in 13/21 Sapien. In 6 patients we used the anchoring technique, 5 with a very large nRVOT and one pyramidal nRVOT. In the 3.5 year follow-up 7 patients developed endocarditis and 3 required a valve redilation, no fractures were observed. PPVI of native RVOT with balloon expandable valves is feasible in a number of selected anatomies, including large or pyramidal nRVOT, using specific techniques, (presenting, LPA anchoring).

Effect of valve design and anticoagulation strategy on 30-day clinical outcomes in transcatheter aortic valve replacement: Results from the BRAVO 3 randomized trial.

BACKGROUND: Selection of valve type and procedural anticoagulant may impact bleeding and vascular complications in transfemoral transcatheter aortic valve replacement (TAVR). We sought to compare outcomes by valve [balloon expandable (BE) or non-BE] and anticoagulant [bivalirudin vs. unfractionated heparin (UFH)] type from the BRAVO-3 trial. METHODS: BRAVO-3 was a randomized multicenter trial including 500 BE-TAVR and 282 non-BE TAVR patients, randomized to bivalirudin versus UFH. Selection of valve type was at the discretion of the operator but randomization was stratified according to valve type. Total follow up was to 30 days. We examined the incidence of Bleeding Academic Research Consortium type ≥3b bleeding, major vascular complications and all ischemic outcomes at 30-days. Outcomes were adjusted using logistic regression analysis. RESULTS: Of the trial cohort, 63.9% were treated with BE valves (n = 251 bivalirudin vs. n = 249 UFH) and 36.1% with non-BE valves (n = 140 bivalirudin vs. n = 142 UFH). Patients treated with non-BE valves were older, with higher euroSCORE I. At 30 days, there were nonsignificant differences between the two valve types for adjusted risk of all-cause death (HR 2.07, 95% CI 0.91-4.70, P = 0.084) and major vascular complications (HR 1.78, 95% CI 0.97-3.26, P = 0.062) with non-BE compared with BE valves, but all other outcomes were similar. A significant interaction was observed between valve and anticoagulant type, with lower risk of major vascular complications with bivalirudin compared with UFH in non-BE TAVR (P-interaction = 0.039). CONCLUSIONS: Majority of patients in the BRAVO 3 trial received BE valves. At 30-days, adjusted risk of clinical outcomes was similar with non-BE vs. BE valves. A significant interaction was observed between valve type and procedural anticoagulant for lower risk of major vascular complications with bivalirudin versus UFH in non-BE TAVR.

Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Implantation in Patients With Small Aortic Annulus: A Meta-Analysis.

Although transcatheter aortic valve implantation (TAVI) is considered a superior option to surgery in patients with small aortic annulus (SAA), it is not clear which type of transcatheter heart valve (THV) has better results in terms of echocardiographic hemodynamics and clinical outcomes. A random-effects meta-analysis was performed comparing balloon-expandable valves (BEVs) and self-expanding valves (SEVs) in patients with SAA who underwent TAVI regarding their impact on hemodynamic and clinical outcomes at short- and midterm follow-up. Relative risk (RR) and mean difference (MD) with 95% confidence interval (95% CI) were measured for the outcomes, as appropriate. Subgroup analyses were performed based on the generation type of devices and study designs. A total of 16 articles comprising 1 randomized trial, 3 propensity-matched studies, and 12 observational studies including 4,341 patients (1,967 in BEV and 2,374 in the SEV group) with SAA were included. The implantation of BEVs correlated with a lower indexed effective orifice area (MD -0.19 [-0.25 to -0.13]) and higher transvalvular mean pressure gradient (MD 3.91, 95% CI 2.96 to 4.87). Compared with SEVs, BEVs had increased risk of prosthesis-patient mismatch (PPM; RR 2.09, 95% CI 1.79 to 2.45) and severe PPM (RR 2.16, 95% CI 1.48 to 3.15). However, BEV had lower moderate and severe paravalvular leak (RR 0.45, 95% CI 0.29 to 0.69), risk of stroke (RR 0.57, 95% CI 0.42 to 0.76), and permanent pacemaker implantation (RR 0.63, 95% CI 0.44 to 0.91). The 1-year all-cause mortality (RR 1.13, 95% CI 0.86 to 1.49) and cardiac-related mortality (RR 1.53, 95% CI 0.24 to 9.81) were not different between the 2 groups. In conclusion, SEVs were associated with larger indexed effective orifice area and lower PPM but higher paravalvular leak. In contrast, patients with SEVs were more likely to develop stroke and required permanent pacemaker implantation. Both THVs did not show difference in terms of early and midterm all-cause and cardiac mortality. Because both types of THVs show similar results regarding mortality data, hemodynamics should be among the factors considered in decision making for patients with SAA who underwent TAVI.

Multicenter comparison of latest-generation balloon-expandable versus self-expanding transcatheter heart valves: Ultra versus Evolut.

BACKGROUND: Direct comparisons of latest-generation balloon-expandable versus self-expanding transcatheter heart valves (THV) are scarce. To compare outcomes after transcatheter aortic valve replacement (TAVR) with SAPIEN 3 Ultra (Ultra) versus Evolut R or Pro (Evolut) THVs. METHODS: 1612 consecutive patients undergoing TAVR with either Ultra (n = 616) or Evolut (n = 996) were included. After propensity score matching (PSM), 467 and 205 matched pairs were identified in the entire cohort and with latest-generation THVs, respectively. Outcomes were investigated up to 30 days after TAVR. RESULTS: After PSM, baseline characteristics were comparable in the entire cohort (n = 934). Device success (92.7% vs. 87.6%; p = 0.011) and need for permanent pacemaker implantation (PPI) (15.2% vs. 8.4%; p = 0.002) were higher for Evolut compared with Ultra. Elevated gradients (≥20 mm Hg) were less frequent (1.6% vs. 10.4%; p < 0.001), whereas rates of ≥ moderate paravalvular leakage (PVL II+) were more frequent for Evolut compared with Ultra (3.7% vs. 1.3%; p = 0.019). With latest-generation THVs (n = 410), device success was comparable (93.2% vs. 89.8%; p = 0.216), whereas the need for PPI was higher for Evolut Pro compared with Ultra (15.6% vs. 9.8%; p = 0.075). Elevated gradients were less frequent (0% vs. 8%; p < 0.001), whereas rates of PVL II+ were more frequent for Evolut compared with Ultra (5.4% vs. 1.5%; p = 0.028). CONCLUSIONS: Device success rates were high with both THV platforms with low rates of adverse events up to 30 days after TAVR. Compared with Ultra, Evolut was associated with higher pacemaker rates as well as PVL II+, but with less elevated gradients.

Conduction disorders after transcatheter aortic valve implantation: A comparison between SAPIEN 3 and SAPIEN 3 Ultra balloon-expandable valves.

Background: Conduction disorders (CD) are the most common complications after Transcatheter Aortic Valve Implantation (TAVI). The last generation of Edwards balloon expandable valves, the SAPIEN 3 Ultra (S3U), is provided with an external sealing skirt that aims to further reduce paravalvular leakage (PVL) compared to SAPIEN 3 (S3) and could potentially lead to higher CD rate. We sought to investigate the rate of new-onset CD in patients undergoing TAVI with the S3 or S3U valve. Methods: We included 582 consecutive patients undergoing TAVI in a single high-volume Center. Patients with previously implanted pacemaker and Valve in valve procedures were excluded. CD rate was evaluated early after implantation and at discharge. Results: No significant difference in the overall CD rate was found between S3 and S3U patients both immediately after the procedure (S3 45.5% vs. S3U 41.8%, p = 0.575) and at discharge (S3 30.4% vs. S3U 35.6%, p = 0.348) with low rate of permanent pacemaker implantation (S3 6.3% vs. S3U 5.5%, p = 0.749). No significant differences were found also in patients with pre-existing atrial fibrillation (S3 8.2% vs. S3U 5%, p = 0.648). A significantly lower rate of PVL was found with S3U compared to S3 (S3 42% vs. S3U 26%, p = 0.007). According to the manufacturer's guidelines we confirmed that S3U were implanted in a significantly higher position compared to S3 (S3 4.89 ± 1.57 mm vs. S3U 4.47 ± 1.36 mm, p = 0.001). Conclusion: No significant difference in the rate of CD, including the need for PPM implantation, was found in patients undergoing TAVI with the S3 compared to S3U. Moreover, S3U significantly reduced the PVL rate.

Propensity-matched comparison of balloon-expandable and self-expanding valves for transcatheter aortic valve replacement in a Chinese population.

Background: Balloon-expandable valves (BEV) and self-expanding valves (SEV) for transcatheter aortic valve replacement (TAVR) have shown promising results in Western populations. Herein, we comparatively evaluated their hemodynamics and early clinical outcomes in a Chinese population. Methods: One hundred seventy-eight patients with symptomatic aortic stenosis who had undergone transfemoral TAVR using SEV (n=153; Venus-A, 97; VitaFlow, 56) or BEV (n=25; Sapien3) from September 2020 to April 2021 were retrospectively enrolled, and 25 pairs were propensity-score matched for 10 baseline variables. The primary study outcomes were aortic valve hemodynamics and postoperative complications at discharge and 3-month follow-up. Results: TAVR was successful in all patients. Compared with SEV group, the BEV group had similarly distributed baseline characteristics, procedural time, hospital stay, new pacemaker implantation, and paravalvular regurgitation grade. We also observed that the BEV group had lower rates of balloon pre-dilation (60% vs. 92%, P=0.018), post-dilation (0 vs. 20%, P=0.050) and second valve implantation (0 vs. 24%, P=0.022); higher mean transaortic gradient (14.3±6.1 vs. 10.8±4.9, P=0.030) and proportion of patients with elevated gradients (20% vs. 0, P=0.050) at discharge; and similar rehospitalization, mean transaortic gradient, new pacemaker implantation, and paravalvular regurgitation grade than the SEV group at the 3-month follow-up. There were no deaths in either group. However, the proportion of patients with elevated gradients in SEV group was higher at 3 months than before discharge (24% vs. 0, P=0.022). Conclusions: BEV and SEV for transfemoral TAVR appear comparably safe and effective, with high device success and favorable 3-month clinical outcomes. However, the transaortic gradient and new pacemaker implantation in the SEV group increased during follow-up, warranting larger studies with longer-term follow-up.

Annular size and interaction with trans-catheter aortic valves for treatment of severe bicuspid aortic valve stenosis: Insights from the BEAT registry.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is safe and feasible in patients with bicuspid aortic valve (BAV), but whether annular size may influence TAVR results in BAV patients remains unclear. We aimed at evaluating the impact of aortic annular size on procedural and clinical outcomes of BAV patients undergoing TAVR, as well as potential interactions between annular dimension and trans-catheter heart valve (THV) type (balloon-expandable (BEV) vs. self-expanding (SEV). METHODS: BEAT is a multicenter registry of consecutive BAV stenosis undergoing TAVR. For this sub-study patients were classified according to annular dimension in small-annulus (area < 400 mm2 or perimeter <72 mm), medium-annulus (area ≥ 400 and < 575 mm2, perimeter ≥72 mm and< 85 mm), large-annulus (area ≥ 575 mm2 or perimeter ≥85 mm). Primary endpoint was Valve Academic Research Consortium-2 (VARC-2) device success. RESULTS: 45(15.5%) patients had small, 132(45.3%) medium, and 114(39.2%) large annuli. Compared with other groups, patients with large annuli were more frequently male, younger, with higher body mass index, larger aortic valve area, higher rate of moderate-severe calcification, lower mean trans-aortic valve gradient and lower left ventricular ejection fraction. In large-annuli SEVs were associated with a lower VARC-2 device success (75.9% vs. 90.6%, p = 0.049) driven by a higher rate of paravalvular valvular leak (PVL) compared to BEVs (20.7% vs. 1.2%, p < 0.001). However, no differences in clinical outcomes were observed according to annular size nor THV type. CONCLUSIONS: TAVR in BAV patients is feasible irrespective of annular size. However in patients with large aortic annulus SEVs were associated with a significantly higher rate of PVLs compared to BEVs.

Personalised Treatment in Aortic Stenosis: A Patient-Tailored Transcatheter Aortic Valve Implantation Approach.

Transcatheter aortic valve replacement (TAVI) has become a game changer in the management of severe aortic stenosis shifting the concept from inoperable or high-risk patients to intermediate or low surgical-risk individuals. Among devices available nowadays, there is no clear evidence that one device is better than the other or that one device is suitable for all patients. The selection of the optimal TAVI valve for every patient represents a challenging process for clinicians, given a large number of currently available devices. Consequently, understanding the advantages and disadvantages of each valve and personalising the valve selection based on patient-specific clinical and anatomical characteristics is paramount. This review article aims to both analyse the available devices in the presence of specific clinical and anatomic features and offer guidance to select the most suitable valve for a given patient.

Device profile of the SAPIEN 3 transcatheter heart valve in low-risk patients with aortic stenosis: overview of its safety and efficacy.

INTRODUCTION: Transcatheter aortic valve replacement (TAVR) has become a treatment of reference for patients with symptomatic severe aortic stenosis, and the balloon-expandable SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve systems are two of the most broadly used worldwide. Lately, TAVR has progressively expanded toward the treatment of low-risk patients. AREAS COVERED: In this review we aimed to describe the main characteristics of the SAPIEN 3 valve, and to delineate the main clinical findings regarding the safety and efficacy associated with this THV system in low-risk patients undergoing TAVR. EXPERT OPINION: The approval of THV systems for use in low-risk patients has been a significant step forward in expanding current TAVR indications. Along with procedural refinement and growing operator experience, device iterations implemented in new-generation THV systems have played a vital role in the successful spread of TAVR. The availability of SAPIEN 3 represented an inflection point, as it allows for a predictable positioning and safer navigability while dramatically decreasing the rate of residual paravalvular leakage compared to previous balloon-expandable systems. However, some unresolved issues remain like the relatively high rates of conduction disturbances and the uncertainty about valve performance in the long-term. Future studies are warranted.

Aortic valve replacement vs. balloon-expandable and self-expandable transcatheter implantation: A network meta-analysis.

INTRODUCTION: Recently, observational data have raised concerns about safety of selfexpandable (SE) compared to balloon-expandable (BE) valves in TAVI, although potentially limited by patient selection bias. METHODS: All Randomized Controlled Trials (RCTs) comparing BE vs. SE TAVI or/and vs. aortic valve replacement (AVR) were included and compared through Network Meta Analysis (NMA). All-cause and cardiovascular (CV) mortality were the primary endpoints, stroke, rates of permanent pacemaker implantation (PPI), moderate/severe paravalvular leak (PVL) and reintervention were the secondary endpoints. Results We obtained data from 11 RCTs, encompassing 9752 patients. After one and two years, no significant differences for allcause and CV mortality were observed. Compared to surgical bioprostheses, both BE and SE TAVI reduced the risk of acute kidney injury (OR 0.42; CI 95% 0.30-0.60 and OR 0.44; CI 95% 0.32-0.60), new-onset atrial fibrillation (OR 0.24; CI 95% 0.14-0.42 and OR 0.21; CI 95% 0.13-0.34) and major bleedings (OR 0.32; CI 95% 0.16-0.65 and OR 0.47; CI 95% 0.25-0.89). The BE prostheses reduced the risk of moderate/severe PVL at 30-day (OR 0.31; CI 95% 0.17-0.55) and of PPI both at 30-day (OR 0.51; CI 95% 0.33-0.79) and 1 year (OR 0.40; CI 95% 0.30-0.55) as compared to SE TAVI. Conclusions A TAVI strategy, independently from BE or SE prostheses, offers a midterm survival comparable to AVR. The BE prostheses are associated with a reduction of PPI and PVL compared to SE prostheses without any differences in all-cause and CV mortality during two years of follow up. PROSPERO ID CRD42020182407.