LVADs in HF: Weigh Complication Risks, Not Just Survival Odds, Studies Say

April 29, 2015

KANSAS CITY, MO — Two new studies scheduled for presentation this week highlight some of the poor clinical outcomes following the implantation of a left ventricular assist device (LVAD) in patients with heart failure and underscore the importance of patient-physician discussions about the device's risks and benefits[1,2].

In the first study, which included 164 patients who received an LVAD as destination therapy or as a bridge to heart transplantation, roughly one-third of patients had a poor clinical outcome—defined as death, stroke, HF readmission, or patient-reported decline in quality of life—at 1 year.

Lead investigator Dr Timothy Fendler (St Luke's Mid America Heart Institute, Kansas City, MO) told heartwire from Medscape that the rate of survival with LVADs in HF patients is fairly well established at this point, with approximately 80% of patients surviving to 1 year. While survival, fittingly, is often the most important outcome to patients and clinicians when deciding on this potentially life-prolonging but invasive therapy, LVADs confer a high risk for a number of adverse events that can lead to death or seriously impair quality of life, he said.

"We wanted to think a little bit more about the things that might matter to patients above and beyond mortality," said Fendler. "We think there might be other serious adverse events that may weigh very heavily when making a decision about a therapy like this. Perhaps not quite as heavily as the risk of death, but we know from the literature that patients not only hope for a good quality of life, but in some clinical scenarios are willing to trade time lived for a guaranteed good quality of life."

The results of the study were scheduled to be presented at the American Heart Association Quality of Care and Outcomes Research (AHA-QCOR) 2015 Scientific Sessions in Baltimore, MD. The meeting, which was scheduled to start April 29, was canceled in the wake of the rioting that followed the death of Freddie Gray.

Poor Global Outcomes and Declining Brain Function

As part of their analysis, researchers devised a clinical composite end point—known as a poor global outcome—that included the occurrence of death, disabling stroke, patient-reported health status (using the Kansas City Cardiomyopathy Questionnaire), or two or more recurrent HF readmissions postimplantation.

Of the 58 patients with poor global outcomes, 64% had died by 1 year, 29% self-reported a diminished quality of life, 5.2% were rehospitalized two or more times for HF, and 1.7% had a disabling stroke. Eight of the patients who died within the first year also experienced an additional adverse event. Patients who received the LVAD as destination therapy were significantly more likely to experience worse clinical outcomes at 1 year than those designated as a bridge to transplant (46.4% vs 23.6%; P=0.01).

In a second study, Fendler analyzed data from the INTERMACS registry to assess the potential risks of cognitive decline in patients who received an LVAD. That study, which also would have been presented at AHA QCOR, included 1151 LVAD patients with 12-month follow-up.

Overall, 29% of patients experienced a significant decline in cognitive function as assessed by the Trailmaking B Test (TBT), a validated measure that is also capable of detecting subclinical stroke. Older patients, those with chronic kidney disease, those with more severe heart failure at baseline, and those who had better TBT scores at baseline were significantly more likely to experience cognitive decline at 12 months.

"We found that the rate was quite high," said Fendler. "The cumulative incidence [of cognitive decline] was almost 30% within the first year following LVAD implantation."

Guiding Clinical Discussions With Patients

To heartwire , Fendler said that the LVAD would be expected to improve end-organ function, whether it is the brain, liver, or kidney, by restoring blood flow from the heart. However, there have been small studies suggesting that LVAD patients might be at risk for cognitive decline. "We also know that patients with LVADs are at risk for clinical strokes," he said. "That's because the device is a foreign body placed inside the heart, and foreign bodies are thrombogenic."

Fendler said they are currently working on another analysis to determine whether the decrease in cognitive function on the TBT observed in the INTERMACS registry is associated with an increased risk of clinical stroke, mortality, or declines in quality of life.

Overall, both studies' results should help physicians guide risk/benefit discussions with advanced heart-failure patients and their families, he said. Fendler added that patient selection for an LVAD consists of a rigorous multidisciplinary approach with a great deal of scrutiny and pretesting to assess eligibility. Despite these run-up discussions with the patient, it can be difficult for them to truly comprehend the risks and the benefits.

"This can be especially true when they're acutely ill and in the hospital when they're being offered the possibility [of an LVAD]," he said. "I think it becomes increasingly more important for us to crystallize for patients the counterbalancing risks and benefits of therapy. The clearer we can be about what the device can offer and what it might put them at risk for, the more informed patients can be and the better able to determine if this is an appropriate therapy for them."

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