LATERAL: LVAD implant reduces risk for stroke

For discussion with your doctor. 

LATERAL: LVAD implant reduces risk for stroke

Medtronic announced that clinical trial data for its left ventricular assist device showed that 95% of recipients were free from disabling stroke after 2 years of follow-up.
The findings of the LATERAL trial, which evaluated the use of the system (HeartWare HVAD, Medtronic) in patients who had the device implanted via thoracotomy, were presented at the American Society for Artificial Internal Organs conference in San Francisco, the company stated in a press release.

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“Remembering my earliest experiences with the very first HVAD system implant in [a] patient more than 15 years ago, I’ve seen both the significant benefits and also the risks for patients who receive a ventricular assist device. These new data are impressive,” Georg Wieselthaler, MD, the director of the heart transplant and mechanical circulatory support programs at the University of California, San Francisco, and a LATERAL trial investigator, said in the release. “Many of us have dedicated our lives’ work to improving this therapy, including minimizing adverse events.”
Research from the trial found that adverse events were more likely to occur during the first 30 days after implant, with a decline in bleeding (1.53 vs. 0.51 events per patient-year; P < .001) and in arrhythmias (3.22 vs. 0.26 events per patient-year; P < .001), according to the release. There was also a decline in strokes at 30 to 180 days (0.51 vs. 0.12 events per patient-year; P = .01), according to the release.
Overall, adverse event rates were meaningfully reduced 1 to 6 months after implant, according to the release.
Late risk for stroke was “very low,” with total stroke occurring at only 0.05 events per patient-year in years 1 and 2 after implant, the release stated. Previously published data from the LATERAL trial showed survival at 87% after 2 years.
The heart system is available in 56 countries and has the “broadest base of clinical evidence of any centrifugal-flow LVAD,” with more than 2,000 clinical trial patients and 18,000 worldwide implants, according to the release.
“These data give us more comprehensive information showing low adverse event and stroke rates for end-stage heart failure patients who receive the HVAD system,” Rob Kowal, MD, PhD, chief medical officer and vice president of medical affairs in the cardiac rhythm and heart failure division at Medtronic, said in the release.
Reference:
Weiselthaler G, et al. Cardiac 1: The Future of MCS. Presented at: American Society for Artificial Internal Organs Annual Conference; June 26-29, 2019; San Francisco.

Cerebrovascular Accidents During Mechanical Circulatory Support

You'll want to talk with your doctor on reducing the risk of stroke if you have LVAD.
http://stroke.ahajournals.org/content/49/5/1197.short?rss=1

New Predictors of Ischemic and Hemorrhagic Strokes and Outcome

Saef Izzy, Daniel B. Rubin, Firas S. Ahmed, Feras Akbik, Simone Renault, Katelyn W. Sylvester, Henrikas Vaitkevicius, Jennifer A. Smallwood, Michael M. Givertz, Steven K. Feske

Stroke. 2018;49:1197-1203

Originally published April 11, 2018

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Abstract

Background and Purpose—Left ventricular assist devices (LVADs) have emerged as an effective treatment for patients with advanced heart failure refractory to medical therapy. Post-LVAD strokes are an important cause of morbidity and reduced quality of life. Data on risks that distinguish between ischemic and hemorrhagic post-LVAD strokes are limited. The aim of this study was to determine the incidence of post-LVAD ischemic and hemorrhagic strokes, their association with stroke risk factors, and their effect on mortality.

Methods—Data are collected prospectively on all patients with LVADs implanted at Brigham and Women’s Hospital. We added retrospectively collected clinical data for these analyses.

Results—From 2007 to 2016, 183 patients (median age, 57; 80% male) underwent implantation of HeartMate II LVAD as a bridge to transplant (52%), destination therapy (39%), or bridge to transplant candidacy (8%). A total of 48 strokes occurred in 39 patients (21%): 28 acute ischemic strokes in 24 patients (13%) and 20 intracerebral hemorrhages in 19 patients (10.3%). First events occurred at a median of 238 days from implantation (interquartile range, 93–515) among those who developed post-LVAD stroke. All but 9 patients (4.9%) were on warfarin (goal international normalized ratio, 2–3.5) and all received aspirin (81–325 mg). Patients with chronic obstructive pulmonary disease were more likely to have an ischemic stroke (odds ratio, 2.96; 95% confidence interval, 1.14–7.70). Dialysis-dependent patients showed a trend toward a higher risk of hemorrhagic stroke (odds ratio, 6.31; 95% confidence interval, 0.99–40.47). Hemorrhagic stroke was associated with higher mortality (odds ratio, 3.92; 95% confidence interval, 1.34–11.45) than ischemic stroke (odds ratio, 3.17; 95% confidence interval, 1.13–8.85).

Stroke is a major cause of morbidity and mortality in patients on LVAD support. Chronic obstructive pulmonary disease increases the risk of ischemic stroke, whereas dialysis may increase the risk of hemorrhagic stroke. Although any stroke increases mortality, post-LVAD hemorrhagic stroke was associated with higher mortality compared with ischemic stroke.

Novel Pericardial LVAD Fails to Impress More strokes and right heart failure with no less device thrombosis

Be careful out there.
http://www.medpagetoday.com/Cardiology/CHF/62856?

• by Nicole Lou
  Contributing Writer, MedPage Today February 01, 2017
• This article is a collaboration between MedPage Today® and:
  

Action Points

• Note that a randomized trial evaluating an intrapericardial LVAD versus a more conventional axial-flow device showed that the new device was non-inferior in terms of a composite endpoint that included death and device failure.
• The new device was associated with a higher rate of stroke and sepsis, however.

As destination therapy for advanced heart failure, the novel HeartWare left ventricular assist device (LVAD) performed on par with the FDA-approved HeartMate II LVAD device in a randomized trial -- but with some safety concerns.
The proportion of patients who survived 2 years after implantation without disabling stroke or device malfunction leading to LVAD removal was non-inferior for the HeartWare (55.4% versus 59.1% for HeartMate II, P=0.01 for non-inferiority), according to Joseph Rogers, MD, of Duke University Medical Center in Durham, N.C., and co-investigators of the ENDURANCE trial.
LVAD malfunction or failure requiring replacement was numerically more common among HeartMate II recipients (16.2% versus 8.8%), the study published in the Feb. 2 issue of the New England Journal of Medicine showed. HeartWare, on the other hand, trended towards more deaths (34.7% versus 26.4%).
"An analysis of the components of the primary endpoint showed no differences between the study group and the control group with regard to death, disabling strokes, or imputed study failures," the authors nonetheless wrote.
The HeartWare device uses a smaller, centrifugal-flow design aimed at reducing thrombus formation by eliminating bearings and instead relying on magnetic and hydrodynamic rotor levitation. It is smaller than the continuous axial-flow HeartMate II LVAD, which provides continuous axial flow, and sits entirely in the pericardial space.
However, even with those design features, the HeartWare failed to show an advantage in the rate of pump exchange due to LVAD thrombosis, Rogers and colleagues reported.
HeartWare was associated with more strokes (29.7% versus 12.1%, P<0.001). Also, HeartWare recipients were more likely to develop right heart failure (38.5% versus 26.8%, P=0.02) and sepsis (23.6% versus 15.4%, P=0.048) during follow-up.
From 2010 to 2012, the ENDURANCE trialists randomized patients to the HeartWare (n=297) or HeartMate II LVADs (n=148). Participants had advanced heart failure and weren't candidates for heart transplants.
Use of antithrombotics was up to the discretion of operators throughout the study.
Rogers and colleagues acknowledged that the HeartWare that they started with at the beginning of the trial wasn't the one they ended up with: the LVAD evolved in the middle of the study (when the first third of patients were already enrolled) with changes to the inflow cannula and a modified coring tool for the ventricle.
In an accompanying editorial, clinicians expressed disappointment with the HeartWare and another new centrifugal-flow LVAD, St. Jude Medical's HeartMate 3.
Data from the MOMENTUM 3 study, first presented in November 2016 at the annual scientific sessions of the American Heart Association and now published in the same issue of NEJM, showed that HeartMate 3 was better at avoiding pump thrombosis than its predecessor, the HeartMate II.
"It is clear, however, that the newest devices have not yet resolved some of the most important problems with LVAD support. It is disappointing that there was no benefit with either of the magnetically levitated centrifugal pumps, as compared with the axial-flow pump, in reducing the risk of bleeding or sepsis," wrote Roland Hetzer, MD, PhD, and Eva M. Delmo Walter, MD, PhD, both of Germany's Cardio Centrum Berlin.
"The risk of right heart failure was not lower with the HeartMate 3 than with the HeartMate II and was actually higher with the HeartWare device," they continued. "Most importantly, stroke risk was not reduced; the overall stroke risk was higher with the HeartWare pump and was not significantly lower with the HeartMate 3."
Hetzer and Walter questioned whether trials can really show that adjustments in the antithrombotic regimen decrease the risk of stroke with these LVADs.
In the meantime, the duo concluded: "The data from MOMENTUM 3 and ENDURANCE revealed to us that none of the pumps is fully superior to the others. The perfect approach to mechanical circulatory support in advanced heart failure has not yet been achieved."

ENDURANCE was supported by HeartWare, which also paid for trial supervision by a clinical research organization.
Rogers, Walter, and Hetzer disclosed no relevant conflicts of interest.
Co-authors reported relationships with HeartWare and St. Jude Medical.

• Reviewed by F. Perry Wilson, MD, MSCE Assistant Professor, Section of Nephrology, Yale School of Medicine and Dorothy Caputo, MA, BSN, RN, Nurse Planner

• Primary Source

  New England Journal of Medicine

  Source Reference: Rogers JG, et al "Intrapericardial left ventricular assist device for advanced heart failure" New Engl J Med 2016; DOI: 10.1056/NEJMoa1602954.

• Secondary Source

  New England Journal of Medicine

  Source Reference: Hetzer R and Delmo Walter EV "Mechanical circulatory support devices -- in progress" New Engl J Med 2016; DOI: 10.1056/NEJMe1613755.