Correlates and Causes of Death in Patients With Severe Symptomatic Aortic Stenosis Who Are Not Eligible to Participate in a Clinical Trial of Transcatheter Aortic Valve Implantation

Abstract

Background— Transcatheter aortic valve implantation is currently being evaluated in patients with severe aortic stenosis who are considered high-risk surgical candidates. This study aimed to detect incidences, causes, and correlates of mortality in patients ineligible to participate in transcatheter aortic valve implantation studies. Methods and Results— From April 2007 to July 2009, a cohort of 362 patients with severe aortic stenosis were screened and did not meet the inclusion/exclusion criteria necessary to participate in a transcatheter aortic valve implantation trial. These patients were classified into 2 groups: group 1 (medical): 274 (75.7%): 97 (35.4%) treated medically and 177 (64.6%) treated with balloon aortic valvuloplasty; and group 2 (surgical): 88 (24.3%). The medical/balloon aortic valvuloplasty group had significantly higher clinical risk compared with the surgical group, with significantly higher Society of Thoracic Surgeons score (12.8±7.0 versus 8.5±5.1; P <0.001) and logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) (42.4±22.8 versus 24.4±18.1; P <0.001). The medical/balloon aortic valvuloplasty group had a higher New York Heart Association functional class, incidence of renal failure, and lower ejection fraction. During median follow-up of 377.5 days, mortality in the medical/balloon aortic valvuloplasty group was 102 (37.2%), and during median follow-up of 386 days, mortality in the surgical group was 19 (21.5%). Multivariable adjustment analysis identified renal failure (hazard ratio [HR]: 5.60), New York Heart Association class IV (HR: 5.88), and aortic systolic pressure (HR: 0.99) as independent correlates for mortality in the medical group, whereas renal failure (HR: 7.45), Society of Thoracic Surgeons score (STS; HR: 1.09) and logistic EuroSCORE (HR: 1.45) were correlates of mortality in the in the surgical group. Conclusion— Patients with severe symptomatic aortic stenosis not included in transcatheter aortic valve implantation trials do poorly and have extremely high mortality rates, especially in nonsurgical groups, and loss of quality of life in surgical groups.

Long-Term Outcomes of Conventional Aortic Valve Replacement in High-Risk Patients: Where Do We Stand?

“…1,2) After the onset of symptoms, patients with severe AS have a poor prognosis with a one-year mortality of 30%-50% with conservative therapy. 3,4) Given current population projections, it is reasonable to expect that the number of patients affected by aortic valve disease will also increase in the coming years.…”

Valvuloplastia aórtica por cateter balão na estenose aórtica degenerativa: impacto terapêutico em pacientes em condição clínica in extremis

“…16 Several studies have correlated the presence of renal insufficiency before the procedure with increased mortality. 9,17,18 A study of 262 patients at high surgical risk undergoing BAV showed that creatinine clearance ≤ 60 mL/min before the procedure is a strong predictor of mortality. 7 The absence of vascular complications in this study may be related to the use of sheaths with small calibre (10F) in all patients, as well as to the immediate withdrawal of the sheath.…”

Aortic Stenosis: Pathophysiology, Diagnosis, and Medical Management of Nonsurgical Patients

“…Surgical repair is the only effective treatment for symptomatic aortic stenosis; however, some patients may not be considered surgical candidates or may require medical stabilization before surgery; other patients refuse surgical options altogether. 6,25 For patients who do not have surgical repair, medical management of angina, exertional syncope, and signs and symptoms of heart failure becomes necessary.…”

“…In another study 6 of 274 medically managed patients with severe aortic stenosis, 66.4% of whom had concomitant coronary artery disease, the cardiac related mortality rate in the median follow-up period of 377.5 days was 43.1%, including a sudden cardiac death rate of 3.9%.…”