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European multicentre experience with the sutureless Perceval valve: clinical and haemodynamic outcomes up to 5 years
Malakh Shrestha1, Theodore Fischlein2, Bart Meuris3
1Cardio-thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany shrestha.malakh.lal@mh-hannover.de.
Insights
The Perceval sutureless aortic valve shows excellent 5-year clinical and hemodynamic outcomes in elderly patients undergoing aortic valve replacement (AVR). This sutureless technique offers a promising alternative for biological aortic valve replacement with low mortality rates.
Area of Science:
- Cardiovascular Surgery
- Medical Devices
- Clinical Trials
Background:
- Aortic valve replacement (AVR) is a common procedure for severe aortic stenosis.
- Sutureless valves offer potential advantages in reducing procedural time and complications.
- Long-term data on sutureless valves are crucial for establishing their efficacy.
Purpose of the Study:
- To summarize 5-year clinical and hemodynamic data of the Perceval sutureless aortic valve.
- To evaluate the safety and efficacy of this device in a large European multicenter trial.
- To assess long-term outcomes in an elderly patient cohort.
Main Methods:
- Prospective, European multicenter trial involving 731 patients undergoing AVR with the Perceval valve.
- Data collected from April 2007 to August 2012, with a cumulative follow-up of 729 patient-years.
- Included both full sternotomy and minimally invasive approaches.
Main Results:
- Excellent 5-year survival rates (74.7%) and low early cardiac-related death rate (1.9%).
- Significant improvements in clinical status and hemodynamic parameters, including reduced gradients and left ventricular mass.
- Low rates of major paravalvular leak (1%) and no instances of valve migration, degeneration, or thrombosis.
Conclusions:
- The Perceval sutureless valve demonstrates excellent and stable clinical and hemodynamic results up to 5 years.
- Low early and late mortality rates were observed, even in an elderly population (40% octogenarians).
- The sutureless technique is a safe and effective alternative for biological aortic valve replacement.
Objectives:
This report summarizes the 5-year clinical and haemodynamic data from three prospective, European multicentre trials with the Perceval sutureless aortic valve.
Methods:
From April 2007 to August 2012, 731 consecutive patients (mean age: 78.5 years; 68.1% females; mean logistic EuroSCORE 10.9%) underwent AVR with the Perceval valve in 25 European centres. Isolated AVR was performed in 498 (68.1%) patients. A minimally invasive approach was performed in 189 (25.9%) cases. The cumulative follow-up was 729 patients-years.
Results:
In isolated AVR, mean cross-clamp and cardiopulmonary bypass times were 30.8 and 50.8 min in full sternotomy, and 37.6 and 64.4 min in the minimally invasive approach, respectively. Early cardiac-related deaths occurred in 1.9%. Overall survival rates at 1 and 5 years were 92.1 and 74.7%, respectively. Major paravalvular leak occurred in 1.4% and 1% at early and late follow-up, respectively. Significant improvement in clinical status was observed postoperatively in the majority of patients. Mean and peak gradients decreased from 42.9 and 74.0 mmHg preoperatively, to 7.8 and 16 mmHg at the 3-year follow-up. LV mass decreased from 254.5 to 177.4 g at 3 years.
Conclusions:
This European multicentre experience, with the largest cohort of patients with sutureless valves to date, shows excellent clinical and haemodynamic results that remain stable even up to the 5-year follow-up. Even in this elderly patient cohort with 40% octogenarians, both early and late mortality rates were very low. There were no valve migrations, structural valve degeneration or valve thrombosis in the follow-up. The sutureless technique is a promising alternative to biological aortic valve replacement.
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