Short-term outcome of the intuity rapid deployment prosthesis: A systematic review and meta-analysis

Abstract

OBJECTIVES: Limited access aortic valve replacement is an alternative approach for the treatment of calcified aortic valve disease. To facilitate limited access aortic valve replacement, rapid deployment valve prostheses have been developed aiming to reduce surgical impact. This systematic review gives an overview of current literature regarding the INTUITY or INTUITY Elite rapid deployment biological valve prosthesis. Methods: Cochrane, Embase and MEDLINE were searched to identify relevant studies. All studies reporting on patients who underwent isolated or combined surgical aortic valve replacement with the INTUITY or INTUITY Elite valve prosthesis were considered eligible. Primary end points were technical success rate, 30-day mortality, cerebrovascular accident, paravalvular leak and permanent pacemaker implantation. Secondary end points included procedural data such as aortic cross-clamping time, cardiopulmonary bypass time and procedural approach. Results: A total of 16 articles fulfilled the inclusion and exclusion criteria and comprised 4.184 patients. Thirty-day mortality was 2.7% (1.9-3.7%), cerebrovascular accident 2.6% (1.4-4.7%), permanent pacemaker implantation 7.9% (6.6-9.5%) and severe postoperative paravalvular leak requiring a reintervention 3.3% (1.7-6.1%). Technical success rate varied between 93.9% and 100%. Conventional median sternotomy was most commonly performed, ranging from 21.7% to 89.6%. Upper hemi-sternotomy was performed more often than anterior right thoracotomy, ranging from 10.4% to 63.3% and 2.2% to 26.1%. The mean transvalvular pressure gradient ranged between 9.0 and 10.3 mmHg at 1 year postoperatively. Conclusions: This review demonstrates that the technical success rate of the INTUITY or INTUITY Elite rapid deployment valve system is high, also in limited access aortic valve replacement. Mortality and cerebrovascular accident rates are low, but the need for postoperative permanent pacemaker implantation and reintervention rate for paravalvular leakage is increased.