One in Six COAPT Patients Had Malnutrition: TEER Helped Regardless

PHOENIX, AZ—One out of six patients who participated in the COAPT trial had malnutrition, which was independently associated with all-cause mortality at 4 years, a post hoc analysis reveals. The link between malnutrition and mortality was seen in the overall cohort, and among those randomized to guideline-directed medical therapy (GDMT), but not in patients randomized to transcatheter edge-to-edge repair (TEER).

The analysis, said Andrea Scotti, MD (Cardiovascular Research Foundation and Montefiore Medical Center, New York, NY), represents one of the first analyses of how malnutrition might impact outcomes in patients with heart failure (HF) and secondary mitral regurgitation (MR), as well as TEER’s effects in patients with baseline malnutrition.

“Malnutrition was an independent predictor of 4-year mortality in patients on GDMT alone, [whereas] TEER improved survival and freedom from heart failure hospitalizations independent of baseline malnutrition status,” said Scotti, who presented the analysis last week at TVT 2023.

Speaking with TCTMD, Scotti pointed out that this analysis was not prespecified but rather was inspired by other studies trying to understand malnutrition distinct from other measures of frailty. “What we can conclude from this is that malnutrition is important. We should screen patients for malnutrition and assess the malnutrition status at baseline because it's a prognostic factor. But also, this doesn't mean that we should not treat these patients; we should treat patients irrespective of malnutrition or not, and actually we should treat them as soon as possible before . . . a vicious cycle of cardiac cachexia and severe malnutrition develops.”

The analysis was published simultaneously in the Journal of the American College of Cardiology.

Checking for Malnutrition

Nutrition status was calculated using the geriatric nutritional risk index (GNRI) in 552 out of 614 COAPT patients with sufficient baseline data, with a cut point of GNRI ≤ 98 used to define malnutrition. The GNRI score is well validated in patients with HF and reduced ejection fraction and combines measures of both albumin and body weight. Since fluid retention and chronic inflammation can influence both anthropometric parameters, like body weight, and serum markers, like albumin, combining both helps to improve the accuracy of the score, Scotti explained.

In all, 17% of the COAPT patients tested met criteria for malnutrition, with 61, 26, and 7 patients, respectively, found to have mild, moderate, or severe malnutrition at baseline.

On multivariate analysis, malnutrition was an independent predictor of 4-year all-cause death for the entire population (adjusted HR 1.37; 95% CI: 1.03-1.82) and among patients treated with GDMT alone (adjusted HR 1.57; 95% CI: 1.08-2.28), but not in patients randomized to TEER on top of GDMT (adjusted HR 1.16; 95% CI: 0.73-1.84).

Malnutrition did not appear to be associated with rates of heart failure hospitalization in the cohort as a whole, or in either of the randomized groups alone, but it was associated with noncardiovascular hospitalizations across groups.

Importantly, said Scotti, the benefit of TEER-plus-GDMT over medical therapy alone in reducing mortality was unchanged by malnutrition status, showing similar benefits in both groups.

Keeping Watchful for Malnutrition

Malnutrition is already on the radar of heart failure specialists, Scotti told TCTMD, but whether there was any interplay with the benefits of TEER had been unclear. “I think this is important for us to know that we can perform this procedure—we are not doing a futile procedure. This is important for interventionalists. For our heart failure colleagues, it's important to acknowledge the importance of malnutrition and that they should involve, also, a nutritional assessment in all their patients.”

Amanda Vest, MBBS, MPH (Tufts Medical Center, Boston, MA), who has done extensive research in the field of heart failure, nutrition, and cachexia, applauded the researchers for going back and looking for malnutrition in the COAPT cohort, particularly given the very high all-cause mortality rates seen at 4 years—68% in those with malnutrition and nearly 53% in those without.

“I'm delighted to see that malnutrition is being considered as one of these risk factors for mortality, because it is incredibly important and it's somewhat under-recognized and undertreated in these patients,” she said.

A number of small studies have suggested that nutrition interventions may improve outcomes in patients with heart failure with reduced EF—Vest herself is leading the ASTRD-HF trial testing whether boosting dietary protein can improve skeletal muscle recovery in heart failure patients.

But beyond a handful of smaller studies, she said, “we don't have a lot of data to support that treating nutrition in a multidisciplinary manner helps prevent mortality. So I, as a cardiologist, am very interested in nutrition and metabolism and I definitely think it's an area that we should be both counseling our patients on currently, as well as ensuring that we don't utilize very restrictive dietary counseling around sodium restriction or restriction of other food types that's unintentionally worsening malnutrition.”

That said, she continued, “we still have fairly limited data to show that it reduces adverse events in this patient population. We need further study in that area.”

Importantly, she added, the GNRI is a screening tool, not a diagnostic one. “That’s important to recognize. The GNRI has been validated in terms of its association with mortality across a range of populations and is a useful tool [for] picking up those at high malnutrition risk . . . but it is not an assessment of a patient's body composition, a patient's nutritional intake, or the completeness of their diet.”

Cause and Effects

During the Q&A following Scotti’s presentation, moderator Nino Mihatov, MD (NewYork-Presbyterian Brooklyn Methodist Hospital, New York, NY), offered his take on what is driving the adverse effects of malnutrition, versus the benefits of the intervention.

“My sense is that our understanding of [mitral] TEER is really as an adjunctive therapy in the management of heart failure, and at the end of the day, this is still a disease of the ventricle,” Mihatov said. “I think that markers of heart failure prognosis, malnutrition being one of them, are probably related, and it seems like TEER can modulate that or can lead to modulation. Is that a fair statement?”

“For sure,” Scotti responded. “We have to acknowledge that malnutrition is a prognostic factor in all of these patients, not the only one . . . but heart failure patients also should be assessed for malnutrition at baseline. If TEER can modulate this—and we don't know, because we did not perform follow-up analysis on malnutrition and how this changes in the follow-up—but we can speculate that maybe yes, because we see that there is a benefit in TEER and especially the mortality was higher in the GDMT-alone patients, but not in patients treated with TEER.”

It might also be, however, that improving physical function and quality of life through TEER leads, in turn, to improvements in nutritional status, Scotti told TCTMD.

Both Scotti and Vest urged their colleagues to consider malnutrition during heart team discussions and to involve nutritionists and dieticians as a way of tackling this risk factor. “Anything you can do to give a shout out to dieticians and the important work of people who are helping promote patients’ healthy eating, that’s awesome,” Vest said.

But further along the care pathway, for everyone involved in deciding which patients are eligible for TEER, the notion that malnutrition should not be a barrier is important, Mihatov noted. “Many times our decision to offer therapy is sometimes influenced by, let’s say, ‘the eyeball test,’ and malnutrition probably factors into that more so than many other [visual cues]: reminding us that there is still value in pursuing TEER in those circumstances is important.”