Transcatheter aortic valve replacement with Lotus and Sapien 3 prosthetic valves: a systematic review and meta-analysis

Abstract

Background: Frequent occurrence of paravalvular leak (PVL) after transcatheter aortic valve replacement (TAVR) was the main concern with early-generation devices and focused technological improvements.Current systematic review and meta-analysis sought to compare outcomes of TAVR for severe native valve stenosis with next-generation devices: Lotus and Sapien 3. Methods: Electronic databases were screened for studies comparing outcomes of TAVR with Lotus and Sapien 3. In a random-effects meta-analysis, the pooled incidence rates of procedural, clinical and functional outcomes according to VARC-2 definitions were assessed.Results: Eleven observational studies including 2,836 patients (Lotus N=862 vs. Sapien 3 N=1,974) met inclusion criteria. No differences were observed regarding composite endpoints-device success and early safety. Similarly, 30-day mortality, major vascular complications, acute kidney injury and serious bleeding events were similar with both devices. Lotus valve demonstrated 35% reduction of the risk for mild PVL: risk ratio (RR) 0.65, 95% confidence interval (CI): 0.49-0.85, P=0.002; but there were no statistical differences with regard to moderate/severe PVL (RR 0.56, 95% CI: 0.18-1.77, P=0.320). Lotus valves produced significantly higher mean transaortic gradients: mean difference (MD) 0.88 mmHg, 95% CI, 0.24-1.53 mmHg, P=0.007; however, without translation into higher rate of prosthesis-patient mismatch (RR 1.10, 95% CI: 0.82-1.47, P=0.540). As compared to Sapien 3, Lotus device placement was associated with significantly higher rate of permanent pacemaker implantation (RR 2.30, 95% CI: 1.95-2.71, P<0.

Transcatheter Aortic Valve Replacement with Self-Expandable ACURATE neo as Compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-Analysis of Randomized and Propensity-Matched Studies

“…More importantly, though, SCOPE I trial, by design, excluded over 300 patients with excessive calcification of aortic valve or left ventricular outflow tract (LVOT), which was not the case in remaining studies included in the current analysis. Presence of calcifications in both aortic annulus and LVOT could have accounted for much higher rates of PPI in the SAPIEN 3 arms across included PS-matched studies (average PPI incidence rate of 15.8%) as compared to SCOPE I trial with 9.3% rate, similarly to what has been already demonstrated for SAPIEN 3 in another meta-analysis by the same group [30].…”

“…Previous observational studies [15][16][17][18][19][20][21] and, among them, the SAVI-TF (Symetis ACURATE neo Valve Implantation Using Transfemoral Access) registry [29,30] reported on excellent short-term outcomes with low complications and, in particular, PPI rates in ACURATE neo valve attributable to the design of the prosthesis. The particularly low gradients also contributed to the similar or better rates of device success for ACURATE neo and SAPIEN 3 in propensity matched comparisons.…”

Predictors of Permanent Pacemaker Implantation in Patients Undergoing Transcatheter Aortic Valve Replacement ‐ A Systematic Review and Meta‐Analysis

“…On review, we found 40 previous meta‐analyses discussing the risk factors of PPM implantation, however in light of the current evidence the applicability of those studies is limited. 92 , 95 , 96 , 97 , 98 , 99 , 100 , 101 , 102 , 103 , 104 , 105 , 106 , 107 , 108 , 109 , 110 , 111 , 112 , 113 , 114 , 115 , 116 , 117 , 118 , 119 , 120 , 121 , 122 , 123 , 124 , 125 , 126 , 127 , 128 , 129 , 130 , 131 , 132 Most of these meta‐analyses included a smaller number of previously published studies ranging from 4 to 41 articles, missing a large amount of contemporary data. The selection criteria and measured predictors were limited with respect to conduction abnormalities evaluated, indications for TAVR, and in some incidences inclusive of SAVR patients.…”

Patient-Tailored Aortic Valve Replacement

“…Consideration should also be given to the higher risk of some THV systems to induce atrioventricular conduction disturbance. However, it is important to realize that the choice of THV type/size and implantation depth is a complex interplay that will determine the final risk of PVL and conduction disturbance (34).…”