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

Abstract

Frequent occurrence of paravalvular leak (PVL) after transcatheter aortic valve replacement (TAVR) was the main concern with earlier-generation devices. Current meta-analysis compared outcomes of TAVR with next-generation devices: ACURATE neo and SAPIEN 3. In random-effects meta-analysis, the pooled incidence rates of procedural, clinical and functional outcomes according to VARC-2 definitions were assessed. One randomized controlled trial and five observational studies including 2818 patients (ACURATE neo n = 1256 vs. SAPIEN 3 n = 1562) met inclusion criteria. ACURATE neo was associated with a 3.7-fold increase of moderate-to-severe PVL (RR (risk ratio): 3.70 (2.04–6.70); P < 0.0001), which was indirectly related to higher observed 30-day mortality with ACURATE valve (RR: 1.77 (1.03–3.04); P = 0.04). Major vascular complications, acute kidney injury, periprocedural myocardial infarction, stroke and serious bleeding events were similar between devices. ACURATE neo demonstrated lower transvalvular pressure gradients both at discharge (P < 0.00001) and at 30 days (P < 0.00001), along with lower risk of patient–prosthesis mismatch (RR: 0.29 (0.10–0.87); P = 0.03) and pacemaker implantation (RR: 0.64 (0.50–0.81); P = 0.0002), but no differences were observed regarding composite endpoints early safety and device success. In conclusion, ACURATE neo, as compared with SAPIEN 3, was associated with higher rates of moderate-to-severe PVL, which were indirectly linked with increased observed 30-day all-cause mortality.

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.…”

“… References 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 , 133 , 134 , 135 …”

Smoking enhances the expression of angiotensin‐converting enzyme 2 involved in the efficiency of severe acute respiratory syndrome coronavirus 2 infection

“…Smoking is one of the risk factors for respiratory infectious disorders, including viral infections. 9 Inflammatory cells infiltrate into the mucosa and glandular tissue due to smoke exposure, which leads to the excessive production of mucus. This has additional harmful effects, such as epithelial cell hyperplasia, prevention of tissue repair, thickened small bronchioles, and emphysema.…”

“…Smoking is one of the risk factors for respiratory infectious disorders, including viral infections 9 . Inflammatory cells infiltrate into the mucosa and glandular tissue due to smoke exposure, which leads to the excessive production of mucus.…”

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. J. Clin. Med. 2020, 9, 397

“…The authors sincerely apologise for the imperfections made during the collection of the data and wish to make the following corrections to this paper [1].…”