Correction to: Cerebrovascular Events in Patients With Centrifugal-Flow Left Ventricular Assist Devices: Propensity Score–Matched Analysis From the Intermacs Registry

Background: Ischemic and hemorrhagic cerebrovascular accidents (ICVA and HCVA, respectively) remain common among patients with centrifugal-flow left ventricular assist devices (CF-LVADs), despite improvements in survival and device longevity. Therefore, the incidence of neurological adverse events (NAEs) associated with two contemporary CF-LVADs, the Abbott HeartMate3 ® (HM3) and the Medtronic HeartWare ™ HVAD ® (HVAD), were compared. Methods: Using the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs), we collected data on adult patients who received a CF-LVAD as a primary isolated implant between 1/1/2017 and 9/30/2019. Major NAEs were defined as transient ischemic attack (TIA), ICVA, and HCVA. The association of HVAD with risk of NAE in the first year post implant was evaluated using propensity score matching to balance for pre-implant risk factors. After matching, freedom from first major NAE in the HM3 and HVAD cohorts was compared with Kaplan-Meier curves. A secondary analysis using multivariable multiphase hazard models was used to identify predictors of NAE, which uses a data driven parametric fit of the early declining and constant phase hazards and the associations of risk factor with either phase. Results: Of 6,205 included patients, 3,076 (49.6%) received the HM3 and 3,129 (50.4%) received the HVAD. Median follow-up was 9 and 12 months (HM3 and HVAD). HVAD patients had more major NAEs (16.4% vs. 6.4%, p <0.001), as well as each subtype (TIA: 3.3% vs. 1.0%, p <0.001; ICVA: 7.7% vs. 3.4%, p <0.001; and HCVA: 7.2% vs. 2.0%, p <0.001), than did HM3 patients. A propensity-matched cohort balanced for pre-implant risk factors showed that HVAD was associated with higher probabilities of major NAEs (% freedom from NAE: 82% vs. 92%, p <0.001). Device type was not significantly associated with NAEs in the early hazard phase, but HVAD was associated with higher incidence of major NAEs during the constant hazard phase (hazard ratio: 5.71, confidence interval: 3.90-8.36). Conclusions: HM3 is associated with lower hazard of major NAEs than is HVAD beyond the early post-implantation period and during the constant hazard phase. Defining the explanation for this observation will inform device selection for individual patients.

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Abstract W P163: Ischemic and Hemorrhagic Cerebrovascular Events after Left Ventricular Assist Devices

Stroke ◽

10.1161/str.46.suppl_1.wp163 ◽

2015 ◽

Vol 46 (suppl_1) ◽

Author(s):

Pouya Tahsili-Fahadan ◽

David R Curfman ◽

Albert A Davis ◽

Noushin Yahyavi-Firouz-Abadi ◽

Michael E Nassif ◽

...

Keyword(s):

Heart Failure ◽

Left Ventricular ◽

Advanced Heart Failure ◽

Ventricular Assist Devices ◽

Left Ventricular Assist Devices ◽

Ventricular Assist ◽

Assist Devices ◽

Cerebrovascular Events ◽

Left Ventricular Assist ◽

Lvad Support

Introduction: Left ventricular assist devices (LVADs) are increasingly implanted for advanced heart failure either as a bridge to transplantation (BTT) or destination therapy (DT). The reported incidence of cerebrovascular events (CVE) following LVAD is 8-25%. The effects of medical comorbidities and perioperative events on the development of CVE are unclear. Methods: CVEs were retrospectively identified from the Barnes-Jewish Hospital LVAD database consisting of 373 patients with mean LVAD support of 13.5 months (range 0 days-8.2 years); Heartmate II 87%, Heartware 13%. Demographic, clinical, and outcome data were collected and analyzed in patients with and without CVE using standard statistical methods. Results: CVE occurred in 71 patients (19%) at a rate of 0.17 per patient-year 24.5±30.7 months after implantation. Coronary artery disease (P=0.007), diabetes mellitus (P=0.02) and LVAD indication of DT (P=0.04) were more common in patients with CVEs. Duration of cardiopulmonary bypass, hospital length of stay and incidence of bacteremia were not different between those with early CVE (within 30 days of implantation, 35%) and without CVE. CVEs were ischemic (ICVE) in 35 (49%), hemorrhagic (HCVE, including intracerebral, subarachnoid, and subdural) in 26 (37%), and both in 10 (14%). Patients with ICVE and HCVE did not differ in demographic variables, pre-LVAD co-morbidities, post-LVAD complications, NIH Stroke Scale at time of event, or anti-thrombotic regimen (ATR), except that events in those on no ATR were only ischemic. Patients with HCVEs were more likely to be discharged with no ATR (P=0.015). Mortality was significantly higher in patients with CVE (59.1% vs. 29.2% in those without CVE) but did not differ by CVE type. In patients with CVE, 57.1% of deaths were secondary to the CVE (ICVE 25%, HCVE 93.7%, P<0.001). Among BTT patients, only 14.6% with CVE underwent transplantation vs. 39.8% without CVE (P =0.002). Conclusions: CVE remains a serious complication of LVAD support for advanced heart failure and is associated with increased mortality and lower rates of heart transplantation. Further investigations to identify risk factors for CVEs in LVAD patients and potential preventive measures including optimal ATRs are warranted.

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Cerebrovascular Events in Patients With Centrifugal-Flow Left Ventricular Assist Devices: Propensity Score–Matched Analysis From the Intermacs Registry

Circulation ◽

10.1161/circulationaha.121.055716d ◽

2021 ◽

Vol 144 (10) ◽

pp. 763-772

Author(s):

Sung-Min Cho ◽

J. Hunter Mehaffey ◽

Susan L. Meyers ◽

Ryan S. Cantor ◽

Randall C. Starling ◽

...

Keyword(s):

Risk Factors ◽

Propensity Score ◽

Cerebrovascular Accident ◽

Left Ventricular ◽

Ventricular Assist Devices ◽

Left Ventricular Assist Devices ◽

Ventricular Assist ◽

Assist Devices ◽

Left Ventricular Assist ◽

Ischemic Attack

Background: Ischemic and hemorrhagic cerebrovascular accidents remain common among patients with centrifugal-flow left ventricular assist devices, despite improvements in survival and device longevity. We compared the incidence of neurologic adverse events (NAEs) associated with 2 contemporary centrifugal-flow left ventricular assist devices: the Abbott HeartMate3 (HM3) and the Medtronic HeartWare HVAD (HVAD). Methods: Using the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs), we collected data on adult patients who received a centrifugal-flow left ventricular assist device as a primary isolated implant between January 1, 2017, and September 30, 2019. Major NAEs were defined as transient ischemic attack, ischemic cerebrovascular accident, or hemorrhagic cerebrovascular accident. The association of HVAD with risk of NAE in the first year after implant was evaluated using propensity score matching to balance for preimplant risk factors. After matching, freedom from first major NAE in the HM3 and HVAD cohorts was compared with Kaplan-Meier curves. A secondary analysis using multivariable multiphase hazard models was used to identify predictors of NAE, which uses a data-driven parametric fit of the early declining and constant phase hazards and the associations of risk factor with either phase. Results: Of 6205 included patients, 3129 (50.4%) received the HM3 and 3076 (49.6%) received the HVAD. Median follow-up was 9 and 12 months (HM3 and HVAD, respectively). Patients receiving HVAD had more major NAEs (16.4% versus 6.4%, P <0.001) as well as each subtype (transient ischemic attack: 3.3% versus 1.0%, P <0.001; ischemic cerebrovascular accident: 7.7% versus 3.4%, P <0.001; hemorrhagic cerebrovascular accident: 7.2% versus 2.0%, P <0.001) than did patients receiving HM3. A propensity-matched cohort balanced for preimplant risk factors showed that HVAD was associated with higher probabilities of major NAEs (% freedom from NAE 82% versus 92%, P <0.001). Device type was not significantly associated with NAEs in the early hazard phase, but HVAD was associated with higher incidence of major NAEs during the constant hazard phase (hazard ratio, 5.71 [CI, 3.90–8.36]). Conclusions: HM3 is associated with lower hazard of major NAEs than is HVAD beyond the early postimplantation period and during the constant hazard phase. Defining the explanation for this observation will inform device selection for individual patients.

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