Clinical profile, treatment assignment and clinical outcome of patients with severe aortic stenosis not eligible to participate in a clinical trial of percutaneous aortic valve replacement.

Patients with severe aortic stenosis and considered at high surgical risk or inoperable, and not eligible for a randomized clinical trial evaluating percutaneous aortic valve replacement (PAVR), were studied. Many of the patients referred to the study did not meet the inclusion criteria and/or had conditions listed in the exclusion criteria. These patients were then deferred to other treatment modalities. The study cohort consisted of 285 patients with severe aortic stenosis referred to participate in a clinical trial of PAVR. Patients were screened for eligibility on the basis of the protocol inclusion and exclusion criteria and deferred to other treatment modalities if they did not meet the enrollment criteria. Those patients were followed clinically by telephone contact or office visits. Of the 285 patients referred for PAVR, 216 (75.8%) were not included. The leading reasons for lack of eligibility were significant peripheral vascular disease in 50 (23.1%), Society of Thoracic Surgeons score <10% in 48 (22.9%), aortic valve area >0.8 cm(2) in 30 (13.9%), significant coronary artery disease in 25 (11.6%), and renal failure in 22 (10.2%). Sixty-nine of these patients (31.9%) were treated medically, 102 (47.2%) with balloon aortic valvuloplasty, and 45 (20.9%) with surgical aortic valve replacement. Major baseline characteristics were similar. Society of Thoracic Surgeons scores were lower in the surgical group compared with the medical and balloon aortic valvuloplasty groups (10.2 +/- 2.5 vs 12.8 +/- 3.3 vs 13.7 +/- 3.3, respectively, p <0.001). During a median follow-up period of 175.5 days (range 55.7 to 344.75), the mortality rate was higher in the balloon aortic valvuloplasty group compared with the medical and surgical aortic valve replacement groups (46 [45.1%] vs 22 [31.9%] vs 10 [22.2%], respectively, p = 0.01). In conclusion, high-risk patients with severe aortic stenosis who are deferred from PAVR often do poorly and incur high mortality rates, especially when treated with balloon valvuloplasty or medical therapy, while a loss of quality of life is apparent in those treated surgically.