New-generation TAVI devices: Which one has the best features?
Five new-generation devices for transcatheter aortic valve implantation (TAVI) feature diverse profiles of early comparative safety and effectiveness, which should be considered for individualized decision-making and patient management, according to a study.
The researchers compared 1-month outcomes associated with five leading new-generation TAVI devices (Acurate, Evolut, Portico, Lotus and Sapien3) using data collected in the prospective observational RISPEVA* study. The dataset of this ongoing investigation was probed to obtain baseline, procedural and 1-month outcome details of patients undergoing TAVI. Unadjusted and propensity score-adjusted methods were utilized for the analysis.
Of the 1,976 patients included, 234 (11.8 percent) were treated with Acurate, 703 (35.6 percent) with Evolut, 151 (7.6 percent) with Lotus, 347 (17.6 percent) with Portico and 541 (27.4 percent) with Sapien3. [Sci Rep 2019;9:17098]
In unadjusted analyses, several significant differences were found for baseline features as well as other discrepancies for procedural features. All TAVI devices showed similarly high procedural success (range, 98.0–99.4 percent; p>0.05) despite their differences. However, more patients had procedural valve migration with Acurate (p=0.007) and major bleeding with Sapien3 (p=0.002).
Unadjusted analysis for 1-month outcomes also revealed significant differences in the composite of death, stroke, myocardial infarction, major vascular complication, major bleeding or renal failure (favouring Portico; p<0.001); major vascular complications (favouring Lotus; p<0.001); renal failure (favouring Portico; p=0.035); and permanent pacemaker implantation (favouring Acurate; p<0.001).
In propensity score-adjusted analyses, Evolut and Portico (p<0.05) were associated with lower rates of major adverse events (p<0.05), Lotus and Portico with fewer major vascular complications (p<0.05), Sapien3 with fewer incidence of renal failure (p<0.05), and Acurate with lower permanent pacemaker implantation (PPI) rates (p<0.05).
“Overall, all recent reports reaffirm the safety of TAVI, confirming its established role in patients with aortic stenosis at intermediate to prohibitive surgical risk and sustaining recent trials testing the role of TAVI in low-risk patients,” the researchers said. [N Engl J Med 2019;380:1695-1705; N Engl J Med 2019;380:1706-1715]
Although adverse events are uncommon, uncertainty persists on the long-term durability of TAVI, considering recent reports on valve deterioration and leaflet thrombosis, they added. [Cardiovasc Interv 2019;12:433-443; Cardiol J 2019;doi:10.5603/CJ.a2019.0019; Eur Heart J 2019;40:456-465]
Balloon-expandable devices were initially considered superior to self-expandable devices in terms of PPI and aortic regurgitation rates. However, in some series or comparisons, the former correlated with higher rates of stroke and vascular complications. [Minerva Cardioangiol 2018;66:747-761; Curr Emerg Hosp Med Rep 2019;doi:10.1007/s40138-019-00202-4]
“Indeed, in light of prior and recent comparative studies on new-generation TAVI devices as well as our own present ones, we may first infer that experienced operators who have confidence with a given device can obtain satisfactory results with any chosen product, but probably each institution should consider becoming familiar with at least two devices with different features, in order to maximize the benefit of individualized device choice, without compromising skills,” the researchers said.