Simple Tool Assesses Frailty in Elderly Considering TAVR

Batya Swift Yasgur MA, LSW

January 24, 2020

New research has offered an approach to the dilemma of whether elderly and potentially frail patients should undergo transcatheter aortic valve replacement (TAVR).

A multicenter group of investigators studied more than 36,200 patients 65 years or older who had undergone TAVR to evaluate the ability of three frailty indices — anemia, albumin level, and 5 m walk speed — to predict 30-day and 1-year mortality.

They found these indices to be independently associated with mortality at both time points and helpful in risk stratification for mortality, with low albumin the most powerful predictor, even after adjustment for potential confounders.

"The impact of frailty on patients' outcomes after TAVR should not be understated and is an important consideration when risk-stratifying patients prior to the procedure," lead author Soroosh Kiani, MD, MS, cardiac electrophysiology fellow, Emory University School of Medicine, Atlanta, told theheart.org | Medscape Cardiology.

The study was published online January 20 in JACC: Cardiovascular Interventions.

Selection Dilemma

TAVR is "an effective and increasingly utilized treatment option for patients with severe aortic stenosis with elevated surgical risk," but "long-term outcomes may be poorer with advancing age and with markers of advanced frailty," the authors write.

"Patient selection can be a dilemma, especially when weighing factors that are difficult to quantify, like frailty," Kiani commented.

"In the case of older adults, there can be a discrepancy between their numeric age and how robust they are," he added.

Previous descriptions of frailty have included an array of measures, such as nutrition status, muscle wasting, and functional and cognitive impairments. Some of these markers are difficult to obtain but are required in risk-stratification tools.

"We know from other studies in other cardiac procedures that patients who are more frail are more vulnerable to poorer outcomes, [so] we wanted to see if this held true among the TAVR population and, if so, what easy-to-quantify metrics we could use to screen these patients for frailty," he said.

The researchers drew on data from the Society of Thoracic Surgeons American College of Cardiology Transcatheter Valve Therapy Registry (STC/ACC TVT), a "collaborative registry program" in which all TAVR facilities in the United States are mandated by the Centers for Medical and Medicaid Services (CMS) to participate.

They identified a cohort of all patients in this registry who had undergone TAVR from November 2011 to June 2016, were 65 years or older, and had not undergone a previous valve procedure.

The cohort was then linked with the CMS dataset to assess 30-day and 1-year clinical outcomes, with the primary outcome being all-cause mortality at 30 days and at 1 year after TAVR.

Secondary outcomes included a composite outcome (all-cause mortality and readmission for heart failure [HF] at 30 days and 1 year after TAVR); the incidence of stroke; myocardial infarction (MI); bleeding complications; readmission for HF at 30 days and 1 year; and length of stay (LOS) of at least 3 days.

The markers of frailty used by the researchers were:·     

  • Serum albumin level, with low albumin defined as below 3.5 mg/dL

  • Anemia, defined as hemoglobin level below 13 mg/dL for men and below 12 mg/dL for women

  • A low 5 m walk test result, defined as completing the test in more than 6 seconds, translating to a walking speed of less than 0.83 m/s, or an inability to compete the test, including the inability to walk.

Incremental Association

Of the patients in the STS/ACC TVT registry, 56,500 patients (mean age, 83 [78 – 88] years;, 47.94% female; 3.65% Hispanic or Latino) met the inclusion criteria.

Of the patients who met the inclusion criteria, 36,242 whose data were linked to the CMS administrative claims data were included in the overall analysis.

For patients included in the survival analysis (n = 23,605), the median follow-up time was 380 days; median follow-up time in those alive at 1 year (n = 19,959) was 405 days.

Outcomes for those with vs without the three indices of frailty at 30 days showed significant relationships with outcome.

30-Day Outcomes After TAVR With vs Without Frailty Indices
Outcome With vs Without Indices P Value
Low albumin
Mortality 6.06% vs 3.75% <.0001
Any bleeding 13.30% vs 11.10% <.0001
Length of stay 6 (3–9) vs 3 (3–6) days <.0001
Rehospitalization 4.51% vs 3.06% <.0001
Anemia
Mortality 4.79% vs 3.76% <.001
Any bleeding 12.40% vs 10.00% <.0001
Length of stay 4 (3–7) vs 4 (2–6) days <.0001
Rehospitalization 4.08% vs 2.71% <.0001
Slow walking speed
Mortality 4.55% vs 3.22% <.001
Any bleeding 11.80% vs 9.46% <.0001
Length of stay 5 (3–8) vs 4 (3–7) days <.0001
Rehospitalization 3.69% vs 2.71% <.0001

At 1 year, the results were even more dramatic.

One-Year Outcomes After TAVR With vs Without Frailty Indices
Outcome With vs Without Indices P Value
Low albumin
Mortality 25.90% vs 14.70% <.0001
Any bleeding 26.30% vs 20.10% <.0001
Rehospitalization 15.50% vs 11.20% <.0001
Anemia
Mortality 20.50% vs 13.30% <.0001
Any bleeding 24.70% vs 16.00% <.0001
Rehospitalization 14.60% vs 9.80% <.0001
Slow walking speed
Mortality 18.07% vs 12.40% <.0001
Any bleeding 22.20% vs 17.30% <.0001
Rehospitalization 12.90% % vs 9.38% <.0001

At 1 year, patients with any positive marker of frailty had poorer survival and a higher incidence of the composite outcome, compared with those without any positive markers — relationships that persisted in adjusted analyses.

Survival was "incrementally poorer" at 1 year among patients with increasing positive markers (adjusted HR for patients with three positive markers, 2.5 [2.1 - 3.0]; P < .001).

Low albumin had the highest association both with 30-day and 1-year mortality (adjusted HR, 1.3 [1.1 - 1.5] and 1.5 [1.4 - 1.6], respectively; P < .001).

"We found that these metrics were independently associated with mortality, as well as readmissions for heart failure at 30 days and 1 year, regardless of the patient's age," Kiani summarized.

"While the strongest single metric was low albumin, we also found that these metrics were incrementally associated with poorer outcomes, including mortality, readmission for heart failure, bleeding after TAVR, and longer lengths of stay," he added.

Easy Parameters

Commenting on the study for theheart.org | Medscape Cardiology, Josep Rodés-Cabau, MD, director, Catheterization and Interventional Laboratories, Quebec Heart and Lung Institute, Quebec City, Canada, called the frailty index "one of the easiest frailty algorithms and scores that have been developed because it includes three parameters — albumin, presence of anemia, and 5 meter speed test — which are very easy to do, are not time-consuming, and relatively easy to implement in real daily practice."

Moreover, the study was "performed in a very large cohort of patients," noted Rodés-Cabau, who was not involved with the study.

One limitation is that the investigators "evaluated patients from 2011 to 2016, and TAVR procedures have evolved a lot since then."

These parameters, therefore, "need validation in a more contemporary cohort of patients," he said.

An accompanying editorial, coauthored by physicians in the Department of Cardiology, St. Thomas' Hospital, King's College, London, raises a "pressing" question: "Once frailty is diagnosed, what do we do about it?"

Ideally, more accurate risk stratification should inform discussions with patients and families, better targeted follow-up, and identification of those unlikely to benefit from the procedure. The decision whether or not to perform TAVR is "individualized…based on heart team discussion and patient involvement," the authors suggest.

Kiani said: "Patients with these frailty metrics may be at risk for poorer outcomes after TAVR, [but] that doesn't mean they shouldn't undergo the procedure. Rather, it should prompt a discussion between the physician and patient."

Moreover, he added, "a deeper investigation into frailty syndrome among patients with these metrics should be strongly considered."

Kiani reports no relevant financial relationships. The other authors' disclosures are listed on the original paper. The disclosures of the editorial authors are likewise listed on the original editorial. Rodés-Cabau has received institutional research grants from and is consultant for Edwards Lifesciences, Medtronic and Boston Scientific.

JACC Cardiovasc Interv. Published online January 20, 2020. Abstract, Editorial

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