One year after transcatheter aortic valve replacement in the United States, the overall mortality was 23.7%, the stroke rate was 4.1%, and the composite outcome of death and stroke was 26.0%, according to a report published online March 10 in JAMA.
Long-term outcomes for TAVR haven’t been well studied until now, yet the procedure is being performed with increasing frequency for aortic stenosis in patients who are too high risk to undergo conventional surgical aortic valve replacement, said Dr. David R. Holmes Jr. of the Mayo Clinic, Rochester, Minn., and his associates.
They assessed 1-year outcomes by analyzing administrative data from the Centers for Medicare & Medicaid Services and clinical data from the Transcatheter Valve Therapies Registry, an initiative of the Society of Thoracic Surgeons and the American College of Cardiology. The study involved 12,182 patients who underwent TAVR at 299 medical centers across the country during a 19-month period. The patients’ median age was 84 years; 95% were white and 52% were women. The transfemoral approach was used in most patients, but alternative approaches were used in roughly 44%. As expected for an elderly, high-risk study population, baseline functional status was poor and comorbidities were common. They included reduced left ventricular ejection fraction (26% of patients), prior stroke (12%), moderate or severe lung disease (28%), renal failure (16%), peripheral vascular disease (32%), and atrial fibrillation (42%), Dr. Holmes and his associates reported (JAMA 2015 March 10 [doi:10.1001/jama.2015.1474]).
In addition to the mortality and stroke rates listed above, the 1-year rate of one rehospitalization was 24.4%, that of two rehospitalizations was 12.5%, and that of three or more rehospitalizations was 11.6%. The 1-year readmission rate specifically for stroke, heart failure, or repeat aortic valve intervention was 18.6%. These are important considerations for elderly, fragile patients because rehospitalizations indicate “an unacceptable quality-of-life outcome” and are very costly, the investigators noted.
Several baseline characteristics, including male sex, severe chronic obstructive pulmonary disease, dialysis-dependent end-stage renal disease, older age, higher STS Predicted Risk of Operative Mortality (PROM) score, a history of atrial fibrillation/flutter, and use of an access route (other than transfemoral), were found to be independently associated with higher 1-year mortality. Thus, “It may be possible to identify patients who may not benefit from this procedure and who should be counseled accordingly.” For example, in this study there was a small (77 patients) very high-risk subset of patients – aged 85-94 years, dependent on dialysis, and having an STS PROM score greater than 15% – whose 1-year mortality was 53.5%.
The STS and the ACC supported this study, and support the Transcatheter Valve Therapies Registry. Dr. Holmes reported having no relevant financial disclosures; his associates reported ties to Boston Scientific, Edwards Lifesciences, Janssen, Eli Lilly, Boehringer Ingelheim, Bayer, and AstraZeneca.