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Influence of Device Type on Stroke Risk in Women Undergoing LVAD Implantation
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The Journal of Heart and Lung Transplantation, Vol 38, No 4S, April 2019
397 Digoxin is Associated with Decreased Survival Free from Hemocompatibility-Related Adverse Events in LVAD Patients - A Propensity Score Matched Analysis A. Pinsino,1 A. Gaudig,2 K.L. Hoffman,3 D. D'Angelo,3 E.A. Royzman,2 G.M. Mondellini,2 F. Castagna,2 A.M. Zuver,2 A.R. Garan,2 H. Takayama,4 K. Takeda,4 Y. Naka,4 R.T. Demmer,5 M. Yuzefpolskaya,2 and P.C. Colombo.2 1Jacobi - Albert Einstein College of Medicine, Bronx, NY; 2 Department of Medicine, Columbia University Medical Center, New York, NY; 3Healthcare Policy and Research, Weill Cornell Medicine, New York, NY; 4Department of Surgery, Columbia University Medical Center, New York, NY; and the 5Epidemiology and Community Health, University of Minnesota, Minneapolis, MN. Purpose: Hemocompatibility-related adverse events (HRAEs) (stroke, suspected pump thrombosis (sPT), gastrointestinal bleeding (GIB)) reduce survival and quality of life in LVAD pts. The association between pharmacotherapy and both HRAEs and survival is poorly characterized. We aimed to assess this association in HeartMate II (HMII) pts. Methods: We retrospectively studied pts implanted between Jan 2011 and Aug 2016. The primary endpoint was survival free from HRAEs. Cox proportional hazard models assessed time to primary endpoint by medication status at the time of the first post-implant outpt visit. Medication status was defined as receiving vs. not receiving PDE5 inhibitors, Digoxin, Aldosterone Receptor Antagonist (ARAs), ACE inhibitors (ACEi) or Angiotensin Receptor Blockers (ARBs), and b Blockers (BBs). A 1:1 propensity score (PS) match was performed based on 16 covariables. Results: Of 209 HMII pts (age 57§14, 19% F), 96 (46%) met the primary endpoint - 16 deaths, 10 strokes, 30 sPT, 40 GIBs - over a mean follow-up of 1.68§1.31 years. In univariable analysis for the primary endpoint, ACE/ ARBs were associated with reduced event rates (HR: 0.62, 0.41-0.96, p=0.03), while Digoxin had a trend toward increased event rates (HR: 1.49, 0.98-2.25, p=0.06). In the PS-matched analysis, the association between the primary endpoint and Digoxin reached significance (HR: 1.56, 1.02-2.39, p=0.04), while the one with ACE/ARBs did not (HR: 0.74, 0.45-1.20, p=0.22). Other drugs did not show any significant association (Fig.). HRs for Digoxin were generally consistent for individual components of the primary endpoint (death: 1.72, 0.75-3.94; stroke: 1.74, 0.555.50; sPT: 1.50, 0.71-3.17; GIB: 1.34, 0.65-2.74). Conclusion: Our results suggest that the outpt use of Digoxin is associated with decreased survival free from HRAEs. Prospective randomized studies are warranted to assess the impact of Digoxin as well as other medications on outcomes among LVAD pts.
398 Influence of Device Type on Stroke Risk in Women Undergoing LVAD Implantation R.J. Vela,1 J. Pruszynski,1 A. Amin,2 M. Drazner,2 L.C. Huffman,1 and M. Peltz.1 1Cardiovascular & Thoracic Surgery, UT Southwestern Medical Center, Dallas, TX; and the 2Internal Medicine, UT Southwestern Medical Center, Dallas, TX.
Purpose: Stroke risk after left ventricular assist device (LVAD) implantation seems to be increased in women. The role of device type has not previously been investigated. We hypothesized that stroke risk in female patients was influenced by LVAD device type. Methods: A retrospective review of all adult patients who underwent implantation of a Heartware HVAD (HW) or Heartmate 2 (HM2) LVAD from January 2010 to July 2018 at our institution was conducted. Demographic and outcome variables in implanted patients were collected. Stroke risk was compared by gender and device type. The Kruskal-Wallis test was used for comparison of non-normal continuous and ordered categorical variables. Non-ordered categorical variables were compared by the Chi square and Fisher’s exact tests. Multivariable logistic regression models were developed to assess the effect of gender and other confounding factors on stroke occurrence. A p %lt 0.05 was considered significant. Results: 204 patients underwent continuous-flow LVAD implantation at our institution over the study period; 141 patients (69%) received a HM2, and 63 patients (31%) received a HW LVAD. In total, 45 implanted patients (22%) were women and 159 patients (78%) were men. Occurrence of stroke was more common in women (47%) then in men (14%), p < 0.001. Univariate analysis suggested device type did not influence stroke risk in female patients (HM2 50%, HW 41%, p = 0.79). However, by multivariate analysis for each device type, female gender was a risk factor for stroke in HM2 patients (OR 8.17, 95% confidence interval 2.32-28.79, p = 0.001) but not HW patients (OR 2.46, 95% confidence interval 0.5111.57, p = 0.26). Conclusion: At our institution, women versus men experienced more strokes after LVAD implantation. This increased stroke risk was particularly pronounced in women receiving a HM2 device. 399 Concentrated Factor Administration and Subsequent Stroke Rates on HeartMate II LVAD Support J. Schultz,1 A. Shaffer,2 J. Misialek,1 H. Shah,1 R. John,2 C. Martin,1 T. Thenappan,1 T. Alexy,1 F. Kamdar,1 and R. Cogswell.1 1Department of Medicine, Division of Cardiology, University of Minnesota, Minneapolis, MN; and the 2Department of Surgery, Division of Cardiovascular Surgery, University of Minnesota, Minneapolis, MN. Purpose: Limited data exists regarding concentrated factor administration during continuous flow left ventricular assist device (CF-LVAD) implantation and subsequent neurologic events. While the hemocompatability profile of CF pumps are presently changing, this is the largest concentrated factor experience reported in a CF-LVAD population to date. Methods: The study cohort consisted of patients with a first time HeartMate II implantation at a single center (n=330). Patients were coded as receiving concentrated factor if prothrombin 4 factor complex or recombinant factor VIIa was charted intra-operatively or within 48 hours of device implantation. Time to first stroke (ischemic or hemorrhagic) was recorded using INTERMACS definitions. Multivariate cox regression was used to assess the association between concentrated factor administration and the time to first stroke. Results: Eighteen percent of patients (60/330) received concentrated factor intra-operatively or within 48 hours of device implantation. During a median follow up time of 488 days, 47 patients developed a stroke on LVAD support (51% ischemic, 49% hemorrhagic). In the final multivariate models, concentrated factor administration was not significantly associated with all cause stroke (HR 0.70, 95% CI 0.32-1.72, p = 0.50), ischemic stroke (HR 1.23, 95% CI 0.43-3.56, p = 0.7), or hemorrhagic stroke (0.39, 95% CI 0.09-1.75, p =0.22). All models were adjusted for age, INTERMACS profile, implant year, ischemic cardiomyopathy diagnosis, diabetes, presence or absence of atrial fibrillation at implantation, and discharge pump speed. Conclusion: While there was no statistical association with stroke rates after concentrated factor administration, the hazard ratios suggests a protective effect against hemorrhagic events and a slight increase in ischemic events with factor administration. Larger data will be needed to fully answer this question in the contemporary continuous flow era.
The Journal of Heart and Lung Transplantation, Vol 38, No 4S, April 2019
397 Digoxin is Associated with Decreased Survival Free from Hemocompatibility-Related Adverse Events in LVAD Patients - A Propensity Score Matched Analysis A. Pinsino,1 A. Gaudig,2 K.L. Hoffman,3 D. D'Angelo,3 E.A. Royzman,2 G.M. Mondellini,2 F. Castagna,2 A.M. Zuver,2 A.R. Garan,2 H. Takayama,4 K. Takeda,4 Y. Naka,4 R.T. Demmer,5 M. Yuzefpolskaya,2 and P.C. Colombo.2 1Jacobi - Albert Einstein College of Medicine, Bronx, NY; 2 Department of Medicine, Columbia University Medical Center, New York, NY; 3Healthcare Policy and Research, Weill Cornell Medicine, New York, NY; 4Department of Surgery, Columbia University Medical Center, New York, NY; and the 5Epidemiology and Community Health, University of Minnesota, Minneapolis, MN. Purpose: Hemocompatibility-related adverse events (HRAEs) (stroke, suspected pump thrombosis (sPT), gastrointestinal bleeding (GIB)) reduce survival and quality of life in LVAD pts. The association between pharmacotherapy and both HRAEs and survival is poorly characterized. We aimed to assess this association in HeartMate II (HMII) pts. Methods: We retrospectively studied pts implanted between Jan 2011 and Aug 2016. The primary endpoint was survival free from HRAEs. Cox proportional hazard models assessed time to primary endpoint by medication status at the time of the first post-implant outpt visit. Medication status was defined as receiving vs. not receiving PDE5 inhibitors, Digoxin, Aldosterone Receptor Antagonist (ARAs), ACE inhibitors (ACEi) or Angiotensin Receptor Blockers (ARBs), and b Blockers (BBs). A 1:1 propensity score (PS) match was performed based on 16 covariables. Results: Of 209 HMII pts (age 57§14, 19% F), 96 (46%) met the primary endpoint - 16 deaths, 10 strokes, 30 sPT, 40 GIBs - over a mean follow-up of 1.68§1.31 years. In univariable analysis for the primary endpoint, ACE/ ARBs were associated with reduced event rates (HR: 0.62, 0.41-0.96, p=0.03), while Digoxin had a trend toward increased event rates (HR: 1.49, 0.98-2.25, p=0.06). In the PS-matched analysis, the association between the primary endpoint and Digoxin reached significance (HR: 1.56, 1.02-2.39, p=0.04), while the one with ACE/ARBs did not (HR: 0.74, 0.45-1.20, p=0.22). Other drugs did not show any significant association (Fig.). HRs for Digoxin were generally consistent for individual components of the primary endpoint (death: 1.72, 0.75-3.94; stroke: 1.74, 0.555.50; sPT: 1.50, 0.71-3.17; GIB: 1.34, 0.65-2.74). Conclusion: Our results suggest that the outpt use of Digoxin is associated with decreased survival free from HRAEs. Prospective randomized studies are warranted to assess the impact of Digoxin as well as other medications on outcomes among LVAD pts.
398 Influence of Device Type on Stroke Risk in Women Undergoing LVAD Implantation R.J. Vela,1 J. Pruszynski,1 A. Amin,2 M. Drazner,2 L.C. Huffman,1 and M. Peltz.1 1Cardiovascular & Thoracic Surgery, UT Southwestern Medical Center, Dallas, TX; and the 2Internal Medicine, UT Southwestern Medical Center, Dallas, TX.
Purpose: Stroke risk after left ventricular assist device (LVAD) implantation seems to be increased in women. The role of device type has not previously been investigated. We hypothesized that stroke risk in female patients was influenced by LVAD device type. Methods: A retrospective review of all adult patients who underwent implantation of a Heartware HVAD (HW) or Heartmate 2 (HM2) LVAD from January 2010 to July 2018 at our institution was conducted. Demographic and outcome variables in implanted patients were collected. Stroke risk was compared by gender and device type. The Kruskal-Wallis test was used for comparison of non-normal continuous and ordered categorical variables. Non-ordered categorical variables were compared by the Chi square and Fisher’s exact tests. Multivariable logistic regression models were developed to assess the effect of gender and other confounding factors on stroke occurrence. A p %lt 0.05 was considered significant. Results: 204 patients underwent continuous-flow LVAD implantation at our institution over the study period; 141 patients (69%) received a HM2, and 63 patients (31%) received a HW LVAD. In total, 45 implanted patients (22%) were women and 159 patients (78%) were men. Occurrence of stroke was more common in women (47%) then in men (14%), p < 0.001. Univariate analysis suggested device type did not influence stroke risk in female patients (HM2 50%, HW 41%, p = 0.79). However, by multivariate analysis for each device type, female gender was a risk factor for stroke in HM2 patients (OR 8.17, 95% confidence interval 2.32-28.79, p = 0.001) but not HW patients (OR 2.46, 95% confidence interval 0.5111.57, p = 0.26). Conclusion: At our institution, women versus men experienced more strokes after LVAD implantation. This increased stroke risk was particularly pronounced in women receiving a HM2 device. 399 Concentrated Factor Administration and Subsequent Stroke Rates on HeartMate II LVAD Support J. Schultz,1 A. Shaffer,2 J. Misialek,1 H. Shah,1 R. John,2 C. Martin,1 T. Thenappan,1 T. Alexy,1 F. Kamdar,1 and R. Cogswell.1 1Department of Medicine, Division of Cardiology, University of Minnesota, Minneapolis, MN; and the 2Department of Surgery, Division of Cardiovascular Surgery, University of Minnesota, Minneapolis, MN. Purpose: Limited data exists regarding concentrated factor administration during continuous flow left ventricular assist device (CF-LVAD) implantation and subsequent neurologic events. While the hemocompatability profile of CF pumps are presently changing, this is the largest concentrated factor experience reported in a CF-LVAD population to date. Methods: The study cohort consisted of patients with a first time HeartMate II implantation at a single center (n=330). Patients were coded as receiving concentrated factor if prothrombin 4 factor complex or recombinant factor VIIa was charted intra-operatively or within 48 hours of device implantation. Time to first stroke (ischemic or hemorrhagic) was recorded using INTERMACS definitions. Multivariate cox regression was used to assess the association between concentrated factor administration and the time to first stroke. Results: Eighteen percent of patients (60/330) received concentrated factor intra-operatively or within 48 hours of device implantation. During a median follow up time of 488 days, 47 patients developed a stroke on LVAD support (51% ischemic, 49% hemorrhagic). In the final multivariate models, concentrated factor administration was not significantly associated with all cause stroke (HR 0.70, 95% CI 0.32-1.72, p = 0.50), ischemic stroke (HR 1.23, 95% CI 0.43-3.56, p = 0.7), or hemorrhagic stroke (0.39, 95% CI 0.09-1.75, p =0.22). All models were adjusted for age, INTERMACS profile, implant year, ischemic cardiomyopathy diagnosis, diabetes, presence or absence of atrial fibrillation at implantation, and discharge pump speed. Conclusion: While there was no statistical association with stroke rates after concentrated factor administration, the hazard ratios suggests a protective effect against hemorrhagic events and a slight increase in ischemic events with factor administration. Larger data will be needed to fully answer this question in the contemporary continuous flow era.