Follow-up results
Mean follow-up time of Group 1 was 6.6±4 years and 4.7±4 years in Group 2, respectively. We observed 10 late deaths in Group 1 and one in Group 2, respectively (p=0.07). Cause of death was cardiac related in 4 patients of Group 1 and one patient in Group 2, respectively. The estimated 5- and 10-year survival was 93±2.9% and 81±5.8% in Group 1 and 96±3.1% and 96±3.1% in Group 2, respectively and did not differ between the groups significantly (p=0.31; Figure 2).
During the follow-up 16 patients required reoperation of the AV, 11 patients of Group 1 (1.7%/patient-year) and 5 patients of Group 2 (2.2%/patient-year) (p=0.5). The estimated 5- and 10-year freedom from reoperation was 93.0±2.1% and 77.1±7.1% in Group 1 and 93.0±5.0% and 76.7±9.6% in Group 2, respectively and did not differ significantly between the two groups (p=0.83, Figure 3). We analysed the cause of reoperation in detail. Group 1: cause of reoperation was severe AR due to endocarditis in 4 patients. Four other patients underwent reoperation due to severe AR as a consequence of leaflet perforation (n=1), leaflet prolapse (n=1), detachment of the pericardial patch at the commissure (n=1) or root dilatation (n=1). A re-repair was possible in the patient with detachment of the pericardial patch. Root replacement (biological valved-conduit) was performed in one patient. The remaining 6 patients received aortic valve replacement. Aortic valve stenosis due to calcification of both leaflets was the cause of reoperation in three other patients. They underwent AV replacement. Group 2: three patients underwent reoperation due to endocarditis. Two other patients were reoperated because of severe AR. In one of them the regurgitation was caused by a leaflet prolapse. In the other case AR was due to calcification of the fused leaflet. In both cases the pericardial patch was intact. The AV was replaced in all 5 patients.
During the follow-up period 4 patients of Group 1 and 3 patients of Group 2 developed AV endocarditis (p=0.6). There was no significant difference in the late stroke rate as the linearized incidence was 0.2%/patient-year in Group 1 vs 0.4%/ patient-year Group 2 (p=0.6). The follow-up results are listed in Table 3. The rate of bleeding events was not significantly different between the two groups (p=0.4). One patient of Group 1 developed gastric bleeding, another one (also Group 1) had cerebral bleeding with minor stroke. One of them was on anticoagulation (coumadin) because of atrial fibrillation. At the latest follow-up, mean New York Heart Association (NYHA) class was 1.4±0.6 in Group 1 and 1.4±0.5 in Group 2, respectively (p=0.5). The cumulative linearized incidence of all valve-related complications (bleeding, stroke, endocarditis, and reoperation) was 2.9%/patient-year in Group 1 and 4%/patient-year in Group 2, respectively (p=0.6).
At the latest follow-up 70 patients (97%) of Group 1 and 40 patients (98%) of Group 2 had AR<2° (p=0.7). Only two patients of Group 1 and 1 patient of Group 2 had AR=2°, respectively (p=0.7). We did not observe patients with AR>2°. The AV mean gradient was significantly higher in Group 1 (17±12 mmHg) in comparison to Group 2 (9±5 mmHg) (p<0.01; Table 4).