One-Year, Real-World TAVR Data Help Identify Risks, Benefits

Marlene Busko

March 12, 2015

ROCHESTER, MN — In a study of more than 12 000 patients who underwent transcatheter aortic-valve replacement (TAVR) in clinical practice in the US, 1 year after the procedure, 23.7% had died, 4.1% had a stroke, and 26% had either died or had a stroke[1].

Furthermore, following TAVR, 59.8% of the patients, who had a median age of 84, went home rather than to a nursing home or extended-care facility. At 1 year, 46.8% of patients who were alive had not been hospitalized again.

This study, published in the March 10, 2015 issue of the Journal of the American Medical Association, updates 30-day results based on the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapies (TVT) registry, which were published earlier.

"In this very high-risk group of patients, if you can keep them out of the hospital and improve their quality of life, that's a pretty good thing," Dr David R Holmes Jr (Mayo Clinic, Rochester, MN) told heartwire from Medscape. "If you're 93, you don't have that many years left, but you'd like to make those years count."

Being very elderly, on dialysis, with severe lung disease, or a high STS Predicted Risk of Operative Mortality (STS PROM) score was linked with a higher risk of 1-year mortality, and women who underwent TAVR had a higher risk of stroke than men.

Taken together, these findings will help clinicians better assess TAVR risks vs benefits and counsel individual patients, Holmes said.

Quality of Life, Survival After TAVR?

Holmes and colleagues examined TVT registry data linked to patient-specific Centers for Medicare & Medicaid Services (CMS) claims data. They identified 12 182 patients who underwent TAVR procedures performed in 299 US hospitals from November 2011 through June 30, 2013.

Most patients (57.4%) had STS PROM scores below 8%; 30.8% had scores between 8% and 15%; and 11.9% had scores above 15%—which indicates low risk of death from surgery, high risk of death from surgery, and inoperable, respectively, Holmes explained.

The median STS PROM score was 7.1%, which was lower than in PARTNER A and PARTNER B (11.8% and 11.2%, respectively), but similar to that in the CoreValve study (7.3%), the researchers note.

Most patients were either 75 to 84 years old (38.2%) or 85 to 94 years old (47%). Only 12.7% were younger than 75 and 2.1% were 95 or older. About half were women.

At 30 days after TAVR, 7% of patients had died and 2.5% had had a stroke.

Multiple characteristics were associated with a greater risk of 1-year mortality.

Characteristics Significantly Associated With Mortality at 1 Year After TAVR

Characteristic HR (95% CI)
Age >95 vs <75 years 1.61 (1.24– 2.09)
Age 85 to 94 vs <75 years 1.35 (1.18–1.55)
Age 75 to 84 vs <75 years 1.23 (1.08–1.41)
Male vs female 1.21 (1.12–1.31)
Dialysis vs creatinine <2 mg/dL 1.66 (1.41–1.95)
Severe chronic obstructive pulmonary disease vs none or mild 1.39 (1.25–1.55)
Other access vs transfemoral 1.37 (1.27–1.48)
STS PROM score >15% vs <8% 1.82 (1.60–2.06)

In contrast, only female sex was associated with an increased risk of stroke, which was "a little surprising" and may be due to women's small body size or to large catheters or other reasons, Holmes said.

"Although this study includes only patients considered to have high risks with [surgical aortic-valve replacement], the majority of this mortality does not represent periprocedural complications, as 30-day mortality was only 7.0%," Holmes and colleagues point out. Thus, it is "imperative to focus on better prediction of the overall risks and benefits of the procedure, particularly given the existing comorbidities of the group of patients being considered for TAVR."

This study may help identify patients who may not benefit from this procedure and should be counseled accordingly, they add. However, there were few events in the exploratory, very high-risk-subgroup analysis, and moreover, quality of life and risk of rehospitalization for congestive heart failure also need to be considered, they caution.

European registries are not as large or comprehensive, Holmes observed. Based on the current data, the researchers are developing and testing a TAVR risk-prediction model "so when you're seeing a patient, you're going to be able to more definitively say, 'The chance of doing poorly is this, or the chance of doing very well is this in a year,' " he said. "These scores will be incredibly important for patients as well as for healthcare systems."

This STS/ACC TVT Registry is an initiative of the Society of Thoracic Surgeons and the American College of Cardiology Foundation. This research was supported by the American College of Cardiology Foundation's National Cardiovascular Data Registry and the Society of Thoracic Surgeons. Holmes had no relevant financial relationships. Disclosures for the coauthors are listed in the article.

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