Author + information
- Arturo Giordano1,
- Francesco Bedogni2,
- Nicola Corcione1,
- Paolo Ferraro1,
- Stefano Messina1,
- Gennaro Maresca1,
- Luca Testa3,
- Nedy Brambilla2,
- Federico De Marco2,
- Carlo Pierli4,
- Giulio Stefanini5,
- Giacomo Frati6 and
- Giuseppe Biondi-Zoccai7
- 1Pineta Grande Hospital, Castel Volturno, Caserta, Italy
- 2Policlinico San Donato, San Donato Milanese, Milan, Italy
- 3IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy
- 4Le Scotte Hospital, Siena, Siena, Italy
- 5Humanitas University, Rozzano, Milan, Milan, Italy
- 6Sapienza University of Rome, Rome, Rome, Italy
- 7Sapienza University of Rome, Latina, Rome, Italy
Transcatheter aortic valve implantation (TAVI) for aortic stenosis is becoming an appealing alternative to surgical aortic valve replacement in high-risk patients and to medical therapy for inoperable ones. Several new-generation TAVI devices have been recently introduced, but comparative analyses are lacking. Equipoise cannot yet be assumed among them. We aimed to compare such five leading new-generation TAVI devices exploiting data collected in the prospective multicenter RISPEVA Study.
We queried the RISPEVA Study dataset to retrieve details on patients undergoing TAVI with Acurate neo devices, Evolut R, Lotus, Portico, Sapien3, and). Baseline, procedural features and early (within 1 month) clinical and echocardiographic results were compared with unadjusted bivariate analysis and adjusted inverse-probability-of-treatment weighting analysis obtained from propensity scores.
A total of 1409 patients were included: 88 (6.2%) with Acurate neo, 823 (58.4%) treated with Evolut R, 91 (6.5%) with Lotus, 82 (5.8%) with Portico, and 325 (23.1%) with Sapien3. Several baseline and procedural differences were evident at unadjusted analysis, including valve disease type, surgical risk, ejection fraction, aortic gradient, aortic regurgitation, anesthesia, hemostasis, use of anti-embolic devices, predilation, post-dilation, contrast, and procedural time (all p<0.05). Nonetheless, device success and procedural success rates were all above 96% (p>0.05). In-hospital event rates were similar, with death rates all below 4% (p=0.168), despite a significant difference in the rate of permanent pacemaker implantation (with higher rates for Evolut R and Lotus, p<0.001). One-month event rates were also similar, with death rates all below 6% (p=0.078), despite significant differences for major vascular complications (with higher rates for Lotus and Sapien3, p=0.024) and permanent pacemaker implantation (with higher rates for Evolut R and Lotus, p<0.001). One-month echocardiographic follow-up showed significant differences in aortic regurgitation 2+ (with higher rates in Portico and Acurate neo, p<0.001), as well as in aortic gradients (with higher values in Lotus and Sapien3, p<0.001) and aortic valve area (with lower values in Portico and Acurate neo, p=0.019). Adjusted analyses for one-month outcomes showed similar results for key clinical outcomes, while highlighting that Acurate neo was associated with significantly lower rates of pacemaker pacemaker implantation (p<0.05), and that Lotus was associated with the lowest rate for aortic regurgitation 2+(p<0.05).
New-generation TAVI devices are not borne equal, and one-month data suggest that Acurate neo may minimize rates of permament pacemaker implantation whereas Lotus reduces the risk of aortic regurgitation. Longer follow-up of the RISPEVA study and others is required to confirm these findings.
STRUCTURAL: Valvular Disease: Aortic