Background: Untreated, symptomatic AS has a high rate of death, but a significant proportion of patients with severe aortic stenosis are poor surgical candidates. Available since 2002, transcatheter aortic-valve implantation (TAVI) is a promising, nonsurgical treatment option for severe AS. However, to date, TAVI has lacked rigorous clinical data.
Study design: Prospective, multicenter, randomized, active-treatment-controlled clinical trial.
Setting: Twenty-one centers, 17 of which were in the U.S.
Synopsis: A total of 358 patients with severe AS who were considered nonsurgical candidates were randomized to either TAVI or standard therapy. A majority (83.8%) of the patients in the standard group underwent balloon aortic valvuloplasty.
Researchers found a significant reduction (HR 0.55, 95% CI 0.40 to 0.74, P<0.001) in all-cause mortality at one year in those patients undergoing TAVI (30.7%) vs. standard therapy (50.7%). Additional benefits included lower rates of the composite endpoints of death from any cause or repeat hospitalization (42.5% vs. 71.6%, P<0.001) and NYHA Functional Class III or IV symptoms (25.2% vs. 58.0%, P<0.001) at one year. However, higher incidences of major strokes (5.0% vs. 1.6%, P=0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001) were seen.
While the one-year mortality benefit of TAVI over standard nonoperative therapy was clearly demonstrated by this study, hospitalists should interpret these data cautiously with respect to their inpatient populations as exclusion criteria were extensive, including bicuspid or noncalcified aortic valve, LVEF less than 20%, and severe renal insufficiency. Additionally, the entity of standard therapy was poorly delineated.
Bottom line: TAVI should be considered in patients with severe aortic stenosis who are not suitable surgical candidates.
Citation: Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597-1607.
ADEPT Score Better Predicts Six-Month Mortality in Nursing Home Residents with Advanced Dementia
Clinical question: Are current Medicare hospice eligibility guidelines accurate enough to predict six-month survival in nursing home residents with dementia when compared with the Advanced Dementia Prognostic Tool (ADEPT)?
Background: Incorrectly estimating the life expectancy in almost 5 million nursing home residents with dementia prevents enrollment to palliative care and hospice for those who would benefit most. Creating and validating a mortality risk score would allow increased services to these residents.
Study design: Prospective cohort study.
Setting: Twenty-one nursing homes in Boston.
Synopsis: A total of 606 nursing home residents with advanced dementia were recruited for this study. Each resident was assessed for Medicare hospice eligibility and assigned an ADEPT score. Mortality rate was determined six months later. These two assessment tools were compared regarding their ability to predict six-month mortality.
The mean ADEPT score was 10.1 (range of 1.0-32.5), with a higher score meaning worse prognosis. Sixty-five residents (10.7%) met Medicare hospice eligibility guidelines. A total of 111 residents (18.3%) died.
The ADEPT score was more sensitive (90% vs. 20%) but less specific (28.3% vs. 89%) than Medicare guidelines. The area under the receiver operating characteristic (AUROC) curve was 0.67 (95% CI, 0.62-0.72) for ADEPT and 0.55 (95% CI, 0.51-0.59) for Medicare.
ADEPT was slightly better than hospice guidelines in predicting six-month mortality.
This study was limited in that the resident data were collected at a single random time point and might not reflect reality, as with palliative care and hospice, there usually is a decline in status that stimulates the referrals.
Bottom line: The ADEPT score might better estimate the six-month mortality in nursing home residents with dementia, which can help expand the enrollment of palliative care and hospice for these residents.