Antonio Miceli explores the data for sutureless and rapid-deployment surgical valves for the management of patients with severe aortic stenosis. He also reviews the place of these new devices alongside traditional surgical valves and transcatheter aortic valve implantation (TAVI) devices.
Data indicate that surgical bioprosthetic valves are associated with a very high rate of freedom from reoperation at 15 years (90% in patients aged 65–75 years; 99% for patients aged >75 years), which has led—according a German registry—to an increase in the use of these valves. However despite these excellent results, new bioprosthetic valves have been developed as an alternative to stented valves to simplify the surgical implantation procedure and to reduce the operation times, particularly in the setting of minimally invasive aortic valve surgery.
Sutureless and rapid-deployment valves are now available (in Europe) and are indicated for the treatment of medium-to-high risk patients undergoing aortic valve replacement, with the aim of avoiding or minimising passing stitches through the aortic annulus and suture knotting. They are, respectively: Perceval (LivaNova) and Edwards Intuity (Edwards Lifesciences); another device—Enable (Medtronic)—was also available but has now been withdrawn from the market. Both of these devices are associated with an excellent haemodynamic performance and excellent postoperative outcomes as well as good midterm survival and a high rate of freedom from reoperation, in absence of structural valve deterioration. For example, a meta-analysis of 1,000 patients undergoing sutureless aortic valve replacement found, overall, that 30-day and one-year mortality was 2.1% and 4.9%, respectively, whereas the predicted mortality was 10%.
Additionally, the rates of stroke, paravalvular leak, permanent pacemaker implantation and valve degeneration/dislocation at one year were 1.5%, 3%, 5.6% and 0.4%, respectively. Finally, compared with the Society of Thoracic Surgeons’ data for traditional surgical aortic valve replacement, surgery with a sutureless valve reduces cardiopulmonary bypass and cross-clamp times by 50% through full sternotomy and by 35% through a minimally invasive approach.
Although further studies on these devices are required, available evidence suggests that the use of sutureless valves and rapid deployment valves decrease operative times, time spent in intensive care unit and time spent in hospital overall, as well as reduce postoperative complications such as blood transfusions, renal failure, atrial fibrillation, prolonged ventilation. Compared with traditional valves, they reduce costs by 25%.
The use of sutureless valves facilitates the minimally invasive approach either for ministernotomy or right anterior minithoracotomy approach. Specifically, a recent European bicentric study has shown this approach is a safe and reproducible procedure that is associated with excellent haemodynamic results, postoperative outcomes and one-year survival. Overall mortality was only 0.7% compared with a predicted mortality of 10% and the rate of major paravalvular leak was only 1.8%. These excellent results have raised the hypothesis that a minimally invasive approach in combination with a sutureless or rapid deployment valve may be the first-line option for the treatment of high-risk operable patients and a real alternative to TAVI. TAVI has been shown to be superior to medical therapy in non-operable patients and to be non-inferior to surgical aortic valve replacement, but several studies and meta-analyses (including data from randomised trials) for more than 8,000 patients have indicated that TAVI is ineffective at reducing early and midterm all-cause mortality compared with surgical aortic valve replacement. Furthermore, a subanalysis of randomised controlled trials showed that, compared with surgery, TAVI is associated with a higher incidence of neurological events, vascular complications, permanent pacemaker implantation and aortic regurgitation. It is well known that paravalvular leak is a predictor of poor survival at two years and, therefore, should be avoided. Based on current literature, TAVI is recommended for inoperable and very high-risk patients, whereas a minimally invasive approach in combination with a sutureless valve should be seen as the first-line treatment option for high-risk but operable patients considered to be in the “grey zone” between TAVI and conventional surgery. In this setting, the role of a heart team is essential in the decision making for high-risk patients undergoing aortic valve replacement.
An international expert consensus panel recently published a report in the European Journal of Cardio-Thoracic Surgery to set out recommendations for the use of sutureless and rapid deployment valves. Authors Borut Gersak (University of Ljubljana School of Medicine and University Medical Center Ljubljana, Ljubljana, Slovenia) and others (including myself) state that such valves should be considered the first-line treatment option for patients with several comorbidities, advanced age or in presence of diseased aortic wall conditions such as small calcified aortic root, porcelain aorta or prior implantation of aortic homograft and stentless valves with the aim of reducing cross-clamp time. However, they also advise that education and proctoring are mandatory for surgeon training in order to reduce the bias of the learning curve and that these new prostheses are not recommended for patients with type 0 Sievers bicuspid aortic valve, in presence of annular abscess, or valve destruction due to infective endocarditis. An international registry collecting data from more than 27 cardiac centres is ongoing and will provide robust clinical evidence for the safety, efficacy and haemodynamic outcomes of sutureless aortic valve replacement.
Antonio Miceli is at Cardiothoracic Center, Istituto Sant’Ambrogio, Gruppo Ospedaliero San Donato, Milan, Italy.