Author + information
- Paolo Pagnotta1,
- Cristina Panico2,
- Francesco Giannini3,
- Luca Baldetti4,
- Francesco Cannata5,
- Matteo Montorfano6,
- Mauro Chiarito7,
- Alaide Chieffo3,
- Azeem Latib3,
- Bernhard Reimers8 and
- Antonio Colombo9
- 1Humanitas Clinical and Research Center, Milan, Milan, Italy
- 2Istituto Clinico Humanitas, Rozzano, Milan, Italy
- 3Interventional Cardiology Institute San Raffaele Hospital, Milan, Milan, Italy
- 4IRCCS San Raffaele Hospital, Milan, Milan, Italy
- 5Istituto Clinico Humanitas, Rozzano, Milan, Milan, Italy
- 6San Raffaele Scientific Institute, Milan, Milan, Italy
- 7Humanitas Clinical Institute, Milan, Milan, Italy
- 8Humanitas Research Hospital, Rozzano, Milan, Italy
- 9Interventional Cardiology Institute San Raffaele Hospital - Stamford Hospital - Columbia University - Centro Cuore Columbus, Milan, Milan, Italy
Transcatheter aortic valve implantation (TAVI) has emerged as a feasible and effective alternative to surgical aortic valve replacement in patients at high and intermediate surgical risk. Although improvements of both materials and implantation techniques have led to better outcomes, bleeding, vascular complications, conduction disorders and paravalvular leak (PVL) remain frequent procedure-related complications. Over the past decade, several transcatheter devices have been developed and tested in order to decrease complications and improve clinical outcomes. The purpose of this study was to report the first Milan experience with the new generation self-expandable SYMETIS Acurate neoTM TF valve.
Consecutive patients who underwent TAVI with SYMETIS Acurate neoTM TF valve at Humanitas Research Hospital (Rozzano, Milan, Italy) and at San Raffaele Scientific Institute (Milan, Italy) were included in a prospective registry between July 2015 and June 2017. Clinical and echocardiographic assessment was performed at baseline, after the procedure, and at early follow up. Baseline characteristics and outcomes were assessed according to valvular academic research consortium (VARC-2) criteria. Atrioventricular and intraventricular conduction delays were assessed on ECGs acquired prior to TAVI and before discharge.
A total of 85 patients were included, with a mean age was 82.7 ± 5.7 years and a mean Society of Thoracic Surgeons score of 5.7 ± 3.8%. Device success was achieved in 83 (87.1 %) patients and only one patient required an immediate second valve-in-valve implantation due to valve migration. Valve implantation resulted in a significant reduction in mean transvalvular gradient (48.32 ±14.54 mmHg vs 7.93 ± 3.18 mmHg, p< 0.001). Moderate to severe paravalvular leak was present in 6 (7.8%) patients at discharge. New conduction disturbances occurred in 29 (34.5%) patients but new permanent pacemaker implantation was required in only 5 (6%) patients. Major bleedings occurred in 5 (6%) patients, major vascular complications in 2 patients (2.4%). There were no peri-procedural deaths, myocardial infractions or strokes. At early follow up (mean of 150 days), 5 patients (5.9%) died, 2 (2.4%) of which for cardiovascular causes.
The preliminary findings of this prospective registry indicate that the new-generation SYMETIS Acurate neoTM TF valve is a safe and effective in routine clinical practice, with a low rate of procedural complications and favorable early clinical outcomes.
STRUCTURAL: Valvular Disease: Aortic