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Implantation of the Syncardia Total Artificial Heart
Published on: July 18, 2014
Stroke risk following implantation of current generation centrifugal flow left ventricular assist devices
Yuting P Chiang1, Daniel Cox2, Jacob N Schroder1
1Division of Cardiothoracic Surgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina.
Insights
The HeartWare HVAD device showed a significantly higher risk of stroke compared to the HeartMate 3 device in left ventricular assist device (LVAD) therapy patients. This finding highlights potential differences in stroke risk between LVAD models.
Area of Science:
- Cardiology
- Neurology
- Biomedical Engineering
Background:
- Stroke is a major complication of left ventricular assist device (LVAD) therapy.
- Evaluating stroke risk in patients receiving HeartWare HVAD or HeartMate 3 devices is crucial for patient safety.
Purpose of the Study:
- To compare the stroke risk between HeartWare HVAD and HeartMate 3 left ventricular assist devices.
- To identify factors associated with stroke in LVAD recipients.
Main Methods:
- Retrospective study of patients receiving first-time HVAD or HM3 implantation.
- Stroke-free survival was the primary endpoint, with stroke defined by neurological deficits and radiographic evidence.
- Multivariate hazard regression analysis was used to identify independent predictors of stroke, accounting for competing risks.
Main Results:
- The study analyzed 163 HVAD and 84 HM3 patients.
- One-year stroke-free survival was 76.8% for HVAD and 84.3% for HM3.
- The HVAD device was associated with a significantly higher stroke risk (HR, 2.57; P=.045) compared to the HM3.
Conclusions:
- Different left ventricular assist device models are associated with significantly different stroke risks.
- The findings suggest a need for careful consideration of device type in mitigating stroke risk during LVAD therapy.
Background And Aim:
Stroke remains a significant complication of left ventricular assist device (LVAD) therapy. We performed a single-center retrospective study evaluating patients undergoing first-time HeartWare HVAD (Medtronic Inc) or HeartMate 3 (Abbott Inc) implantation from September 2009-February 2018.
Methods:
Exclusion criteria were age <18 and preoperative ECMO. The primary endpoint was stroke-free survival. Stroke was defined as new neurological deficits persisting >24 hours with corresponding radiographic evidence. Risk factors evaluated included demographics, medical comorbidities, heart failure etiology, LVAD indication, INTERMACS profile, and device type. Univariate predictors (P < .15) and variables clinically suspected to raise stroke risk were entered in a multivariate hazard regression model, specified using backward selection of covariates and accounting for competing risks of transplant/LVAD exchange.
Results:
A total of 163 HVAD and 84 HM3 patients were analyzed. Median follow up (until death, censoring for transplant/LVAD removal, or end of follow up) was 1.2 years in HVAD patients and 1.4 years in HM3 patients. Stroke occurred in 24 HVAD patients (15 ischemic, 9 hemorrhagic) and 6 HM3 patients (4 ischemic, 2 hemorrhagic). One-year stroke-free survival was 76.8% for HVAD and 84.3% for HM3. Thirty-day mortality following stroke was 41.7% for HVAD and 66.7% for HM3; 54.2% of HVAD strokes were disabling compared to 83.3% of HM3 strokes. Age, LVAD indication, and device type were associated (P < .15) with stroke on univariate analysis. On multivariate analysis, the HVAD was associated with significantly higher stroke risk (hazard ratio, 2.57; 95% confidence interval, 1.02-6.44; P = .045).
Conclusions:
Different LVAD models appear to be associated with significantly different stroke risks.

