This post-hoc analysis of data from a randomized controlled trial found that patients who underwent the Ross procedure for aortic valve disease had excellent long-term survival compared to the general population as well as long-term freedom from reintervention.
Summary: Aortic valve disease is the most common cause of valvular heart disease in the United States. Surgical aortic valve replacement (AVR) has been the standard of care for the management of aortic valve lesions not amenable to repair. Given the inherent limitations of bioprosthetic valves (limited lifetime durability) and mechanical valves (require lifelong anticoagulation), there has been considerable interest in the pursuit of better aortic valve substitutes. The Ross procedure is an operation that replaces the patient’s disease aortic valve with their own pulmonary valve (autograft) and implants a pulmonary valve homograft in the pulmonic position (homograft). This procedure is the only AVR operation that utilizes a living tissue valve substitute and has been shown to produce excellent hemodynamics, with limited valve-related complications and no need for lifelong anticoagulation. However, some studies have raised concerns about the technical complexity of the operation compared to standard AVR and the long-term durability of the pulmonary autograft in the aortic position. The present study is a post hoc analysis of clinical trial data aimed at evaluating long-term clinical and echocardiographic outcomes following the Ross procedure.
The study was a retrospective analysis of a single institution, randomized controlled trial that enrolled patients less than 69 years old with aortic valve disease requiring AVR from 1994 to 2001. In the initial trial, patients were randomized 1:1 to undergo AVR with either aortic valve homograft or Ross procedure. The trial included patients with concomitant aortic root or ascending aortic dilatation (>5 cm), bicuspid aortic valve disease, active endocarditis, rheumatic heart disease, decreased ejection fraction, or those who had previous cardiac surgery. Patients with Marfan’s syndrome, rheumatoid arthritis, and Reiter’s syndrome were excluded from the study. Of note, all Ross procedures were performed by a single surgeon using the same technique during the study period. The primary endpoint was long-term survival. Secondary endpoints include freedom from any valve-related reintervention (pulmonary autograft in aortic position or pulmonary homograft in pulmonic position) and longitudinal evaluation of autograft and homograft regurgitation, autograft root dimensions, and functional status at last follow-up. This post-hoc analysis only evaluated outcomes for the patients randomized to the Ross procedure in the initial trial, and therefore does not include comparative data on the patients randomized to aortic homograft.
A total of 108 patients (mean age 38 years, 85% male) were randomly assigned to the Ross procedure in the initial trial. The most common aortic valve pathology was isolated aortic insufficiency (n=49, 45%). Notably, one-third of patients underwent a previous AVR with either a homograft (n=24, 22%) or mechanical/bioprosthetic substitute (n=13, 12%). Overall survival in this cohort at 25-years from the time of the Ross procedure was 83% (95% CI, 75.5-91.2%) with only one perioperative death. This represents a 99.1% (95% CI 91.8-100%) relative survival when compared to age, sex, and country of origin matched controls in the general population. Freedom from any Ross-related reintervention at 25-years was 71.1% (95% CI 61.6-82%), with 17 patients (15.7%) requiring 18 reinterventions on their pulmonary autograft and 14 patients (13%) requiring 18 reinterventions on their pulmonary homograft. For those who underwent reintervention on the autograft, the most common indication was aortic insufficiency with or without neo-aortic root dilation. In comparison, indications for intervention on the pulmonary homograft were more varied, and included pulmonary stenosis (7 patients), endocarditis (5 patients), severe pulmonary insufficiency (2 patients), and undetermined cause (4 patients). Older age at time of operation was associated with a lower risk for any reintervention (HR 0.96, 95% CI 0.92-0.99, p=0.02) and for homograft reintervention (HR 0.93, 95% CI 0.88-0.99, p=0.02). Interestingly, preoperative severe aortic regurgitation and previous aortic valve interventions were not found to be associated with an elevated risk of valve reintervention after the Ross procedure. Finally, despite a slow yet steady progression of autograft insufficiency in this cohort, the majority of patients had mild or mild-to-moderate autograft insufficiency, stable neo-aortic root diameters, and normal left ventricular ejection fractions during the follow-up period. This study was, first and foremost, limited by small sample size. Similarly, since each surgery was performed by a single surgeon at a Ross center of excellence, these results should be interpreted with some caution until more data on this topic is accrued.
Bottom line: The Ross procedure may provide excellent long-term durability and survival for select, younger patients undergoing AVR by an experienced surgeon and should be considered in surgical armamentarium to optimize the lifetime management of aortic valve disease.