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Older Patients Benefited from Transfemoral TAVR
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Transfemoral transcatheter aortic valve replacement for severe aortic stenosis in patients older than 85 years yielded outcomes similar to those in younger patients, recent study findings showed.
The investigators said there are insufficient data demonstrating the effect of age on baseline characteristics and outcome measures in individuals with severe aortic stenosis who undergo TAVR.
The current analysis included 293 patients, 93 of whom were older than 85 years and 200 of whom were aged 85 years or younger. The aim of the trial was to describe baseline clinical profile of these patients and determine the effect of age in the transfemoral TAVR setting.
The mean patient age was 85 ± 5.3 years (range, 63-98 years). The older cohort was 70% women, whereas the younger cohort was 57.5% women (P=.043). EuroSCORE index and preprocedural aortic valve area, along with other baseline clinical profile measures, were similar between the two age-group cohorts.
Procedures were conducted at the Tel Aviv Medical Center.
The investigators observed no significant differences between the two groups regarding multiple outcome measures, including:
- 30-day mortality (≤85 years, 1.5% vs. >85 years, 4.3%; P=.14);
- Major vascular complications (≤85 years, 2.5% vs. >85 years, 4.3%; P=.41);
- New pacemaker (≤85 years, 23.5% vs. >85 years, 21.5%; P=.7);
- Length of hospital stay (≤85 years, 8 days vs. >85 years, 8.6 days; P=.19);
- 30-day NYHA functional capacity (≤85 years, 1.3 vs. >85 years, 1.4; P=.45).
No change in outcomes was reported when adjustments were made for clinical differences at baseline.
The investigators concluded that transfemoral TAVR may benefit older as well as younger patients in terms of the observed clinical outcomes.
Disclosure: The researchers report no relevant financial disclosures.
Perspective
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Jacob Dal-Bianco, MD
This study by Havakuk and colleagues reports on a single-center, real-world TAVR experience in high surgical risk patients with symptomatic, severe aortic stenosis. Accepting the limitations of cardiac surgery risk calculation and estimation, these patients appear to have been of somewhat lower risk than the patients in the PARTNER cohort A trial. This and the growing experience with TAVR technology likely explain the relatively low observed rate of procedural complications, the remarkable low short- and long-term all-cause mortality and the encouraging HF symptom improvements. The risk of older age seems largely limited to manageable procedural complications not leading to increased 30-day mortality. As expected, long-term all-cause mortality is higher in older compared with younger patients.
Main caveats in applying these findings to the current US TAVR practice are that 84% of patients were treated with the Medtronic CoreValve system, a TAVR technology that is currently in US trial evaluation and not FDA approved for commercial “off the shelf” use; and all patients were treated via the transfemoral approach and thus the reported findings may not apply to patients treated with transapical TAVR.
Nevertheless, this study and ongoing large TAVR registries show that routine, real-world TAVR has a favorable risk-to-benefit profile. The key prerequisites for this favorable profile are appropriate patient selection and a heart valve program experienced in pre-, intra- and post-procedural TAVR patient care. Patient selection starts with appropriate surgical risk classification, anatomic suitability and careful identification of those patients in whom TAVR would meaningfully improve quality of life and the natural history of aortic stenosis. Old age seen isolated as a number should not preclude TAVR consideration. As stated by others previously, the goal is to identify and treat those patients who would die from aortic stenosis and not patients with aortic stenosis.
The patient’s and physician’s temptation to apply TAVR in lower than high-risk patients is currently not supported by medical evidence, but in evaluation in the ongoing PARTNER II (Edwards Lifesciences Sapien valves) and SURTAVI (Medtronic CoreValve system) trials. Potential future TAVR indication broadening will also depend on TAVR bioprosthesis durability and long-term hemodynamic characteristics, and ongoing TAVR delivery system and bioprosthesis design improvements with the aim to minimize paravalvular leak and neurologic and vascular complications.
TAVR is a very exciting and critically needed option in aortic stenosis therapy. Predicting procedural success and especially symptom and mortality benefit in an individual patient can be challenging and is largely dependent on a heart valve program’s TAVR expertise and experience. The importance of appropriate patient selection cannot be overstated and ongoing research efforts are needed to further optimize this process.
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