Marlene Busko

April 12, 2017

SAN DIEGO — For some ambulatory patients with advanced heart failure and symptoms at rest who received a left ventricular assist device (LVAD), there was a nonsignificant trend toward improved 1-year survival, results from a new study show.

Patients who meet the criteria for Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 4, "who are limited at home with symptoms at rest, should be strongly advised to seek evaluation for ventricular assist devices," said investigator Lynne Stevenson, MD, from Brigham and Women's Hospital in Boston.

The benefits of an LVAD for seriously ill patients who meet the criteria for INTERMACS profiles 2 and 3 have been demonstrated in REMATCH (N Engl J Med. 2001;345:1435-1443) and other studies. But little research has been done on patients who meet the criteria for INTERMACS profiles 4 to 7, who are not quite as sick.

So Dr Stevenson and her colleagues looked at 1-year survival in this population. The findings were presented here at the International Society of Heart and Lung Transplantation 2017 Scientific Sessions.

The team compared patients with advanced heart failure — defined as NYHA class III to IV and INTERMACS profile 4 to 7 — who were treated with optimal medical therapy or an LVAD.

The 1753 patients in the INTERMACS cohort received an LVAD. Of these, 80% met the criteria for profile 4, 13% for profile 5, 4% for profile 6, and 3% for profile 7.

The 161 patients identified from the Medical Arm of Mechanically Assisted Circulatory Support (MedaMACS) registry received guideline-directed medical therapy, were not dependent on inotropes, were not on a wait list for heart transplantation, and had at least one hospitalization for heart failure in the previous year. They were seen at 11 transplant centers in the United States from May 2013 to October 2015 and were followed for 1 to 2 years.

At baseline, the mean age of the MedaMACS patients was 59 years, mean left-ventricular ejection fraction was 21%, mean NT-proBNP was 5365 pg/mL, 69% of the patients were white, and 36% were women. Almost all of the patients — 90% — were receiving a beta blocker, 64% were receiving an aldosterone antagonist, and 60% were receiving an angiotensin-converting-enzyme inhibitor or an angiotensin II receptor blocker.

In the MedaMACS cohort, 49% of the patients met the criteria for INTERMACS profile 6, 32% for profile 5, 12% for profile 4, and 7% for profile 7.

Only 53% of the MedaMACS patients met the primary end point — survival free of transplantation or LVAD at 1 year — and more than half were hospitalized at least once.

Survival outcomes were similar in this cohort, regardless of INTERMACS profile.

Table. 1-Year Outcomes for the 161 MedaMACS Patients

Outcome n %
Death 39 24
LVAD implantation 17 11
Transplantation 19 12
Initiation of inotropes 22 14
≥1 rehospitalization 92 57

 

One-year survival was similar in the MedaMACS and INTERMACS cohorts.

However, for profile 4 patients who received an LVAD, there was a nonsignificant trend toward better 1-year survival; only 219 of the 1409 INTERMACS patients died, whereas six of 21 MedaMACS patients died (15.5% vs 28.6%; P = .07).

Mean scores on the 100-point EuroQoL quality-of-life visual analog scale improved from 43 to 70 in the INTERMACS cohort, and from 56 to 65 in the MedaMACS cohort. However, 1-year quality-of-life measures were missing for half of the patients.

Management of Patients in the "Grey Zone" Remains Unclear

INTERMACS profile 4 to 7 is a "grey zone," said discussant Luciano Potena, MD, from Bologna University in Italy.

In patients with higher INTERMACS profiles, "decision-making should be tailored to the patient, based on their symptoms and predicted risk of post-VAD complications," he explained. "We should not forget that we may have a less-symptomatic patient who cannot walk properly because of a stroke caused by the VAD."

Although this study indicates that survival is no worse with an LVAD than with medical therapy in these patients, it would be good to know 2- or 3-year outcomes, Dr Potena added.

This study is just an "initial step," said study investigator Amrut Ambardekar, MD, from the University of Colorado Denver.

The REVIVAL study (NCT01369407), which has completed enrollment, will follow 400 heart failure patients with higher INTERMACS profiles for 2 years, and should provide further insight on LVAD use, he explained.

Dr Stevenson reports being a consultant for and receiving grants and research support from St. Jude Medical, receiving financial support from Novartis, and being a scientific medical advisor for Medtronic. Dr Potena reports receiving research grants, being a principal site investigator, and being a consultant for Novartis, Qiagen, and Biotest. Dr Ambardekar has disclosed no relevant financial relationships.

International Society of Heart and Lung Transplantation (ISHLT) 2017 Scientific Sessions: Abstract 0496. Presented April 8, 2017.

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