Author + information
- Arturo Giordano1,
- Francesco Bedogni2,
- Nicola Corcione1,
- Stefano Messina1,
- Paolo Ferraro1,
- Gennaro Maresca1,
- Luca Testa3,
- Nedy Brambilla4,
- Federico De Marco4,
- Carlo Pierli5,
- Giulio Stefanini6,
- Giacomo Frati7 and
- Giuseppe Biondi-Zoccai8
- 1Pineta Grande Hospital, Castel Volturno, Caserta, Italy
- 2Policlinico San Donato, Milano, Milan, Italy
- 3IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy
- 4Policlinico San Donato, San Donato Milanese, Milan, Italy
- 5Le Scotte Hospital, Siena, Siena, Italy
- 6Humanitas University, Rozzano, Milan, Milan, Italy
- 7Sapienza University of Rome, Rome, Rome, Italy
- 8Sapienza University of Rome, Latina, Rome, Italy
Transcatheter aortic valve implantation (TAVI) has become a mainstay in the management of significant aortic stenosis in patients at high or intermediate surgical risk. Predilation is often performed to facilitate TAVI implantation, but may be associated with embolization or rupture. It is uncertain whether predilation is needed also in the new-generation TAVI device era.
We queried the data collected in the prospective multicenter RISPEVA Study, comparing patients with vs without predilation receiving Acurate neo, Evolut R, Lotus, Portico, Sapien3, or devices. 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 subjects were included, 1055 (74.9%) receiving predilation, and 354 (25.1%) undergoing direct TAVI. Patients undergoing predilation had a higher baseline prevalence of pure aortic stenosis, lower prevalence of prior cardiac surgery, lower EuroSCORE II, higher aortic gradients and lower prevalence of aortic regurgitation 2+ (all p<0.05). Other significant differences between subjects undergoing predilation vs no predilation included general anesthesia, hemostasis device, and device type, with predilation being more proportionally frequent in those receiving Acurate neo, Portico, and Sapien3 (all p<0.05). In-hospital clinical outcomes were similar in the 2 groups, as were the 1-month rates of death (11 [3.1%] vs 15 [1.4%] in those who had undergone direct TAVI, p=0.276), stroke (6 [1.7%] vs 16 [1.5%], p=0.947), myocardial infarction (1 [0.3%] vs 3 [0.3%], p=0.315), major bleeding (9 [2.5%] vs [p=0.967), major vascular complication (18 [5.1%] vs 30 [2.8%], p=0.096), and pacemaker implantation (56 [15.8%] vs 160 [15.2%], 0.918). One-month echocardiophic follow-up showed similar results for ejection fraction (53.4±8.8 vs 51.9±10.9 in those who had undergone direct TAVI, p=0.559), peak aortic gradient (17.1±11.4 vs 18.3±9.7 mm Hg, p=0.214), mean aortic gradient (9.0±5.2 vs 9.7±5.6, p=0.151), and aortic regurgitation 2+ (61 [7.9%] vs 33 [12.6%], p=0.384), whereas aortic valve area appeared greated in patients who had received predilation (1.54±0.65 vs 1.48±0.48 cm2, p=0.036).
Direct TAVI is associated with similar clinical results to TAVI after predilation with new-generation devices. Whether predilation can improve long-term echocardiographic results awaits longer follow-up of the RISPEVA study and others.
STRUCTURAL: Valvular Disease: Aortic