Prior Clotting Events as Predictors of Post LVAD Morbidity and Mortality

Prior Clotting Events as Predictors of Post LVAD Morbidity and Mortality

S250 The Journal of Heart and Lung Transplantation, Vol 36, No 4S, April 2017 6( 53) De-Airing Method of HeartMate II LVAD Influences Post-Operativ...

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S250

The Journal of Heart and Lung Transplantation, Vol 36, No 4S, April 2017

6( 53) De-Airing Method of HeartMate II LVAD Influences Post-Operative LDH: A Possible Explanation for Some Thrombotic Events D. Tanaka ,1 A. Boyle,2 J.W. Entwistle.1  1Cardiothoracic Surgery, Thomas Jefferson University, Philadelphia, PA; 2Cardiology, Thomas Jefferson University, Philadelphia, PA. Purpose: Pump thrombosis (PT) is a relatively uncommon but serious complication of a left ventricular assist device (LVAD). Rising LDH levels are a marker of hemolysis which may be caused by PT. We believe that 1) implantation technique influences the rate of PT; 2) thrombus present early after implantation does not completely resolve; 3) post-operative LDH levels are influenced by the presence of small thrombi; and 4) de-airing with the pump turned on and a clamp across the outflow graft prevents heat dissipation from mechanical bearings of the HeartMate II (HMII) and leads to early thrombus formation. We compared the incidence of PT and LDH levels using two de-airing methods. Methods: Patients who underwent HMII implantation from November 2012 to February 2016 were retrospectively reviewed. Patients were separated into two groups depending on the timing of removing the clamp from the outflow graft. Patients in Group 1 underwent de-airing by turning on the pump with the vascular clamp on the outflow graft and patients in Group 2 were completely de-aired with the pump off and the pump was only activated after removing the clamp. The incidence of PT was compared between two groups. LDH levels were averaged over postoperative day 1 to 1 month (30 days) for early postoperative period and 1 month to 3 months (31 to 90 days) for late postoperative period. Results: There were 45 patients in Group 1 (“clamp on”) and 33 patients in Group 2 (“clamp off”). Ischemic cardiomyopathy was more common in Group 1 (p= 0.01) and patients in Group 1 received more red blood cell transfusion during implantation (p< 0.0001). No patient had suspected air embolization. Five patients had PT in group 1 but none in Group 2 (p= 0.07). PT occurred within 3 months after initial implantation in 4 of the 5 patients. Average LDH levels in the early postoperative period were similar (404±168 IU/L vs 425±267 IU/L; p= 0.71). However, average LDH levels in the late postoperative period were significantly higher in Group 1 (388±214 IU/L vs 313±73 IU/L; p= 0.045). Conclusion: De-airing a running HMII with the outflow graft clamped increases LDH levels, suggesting that there may be a nidus of thrombus on the bearings caused by the lack of heat dissipation. This may increase the incidence of PT. Delaying pump activation until removal of the clamp on the outflow graft may help further decrease the incidence of PT after HMII implantation.

of Follow-up were 222 ±78 days). There were no thrombotic events or mortality events. Conclusion: Anti-coagulation bridging with LMWH in HVAD patients is safe and effective. Prospective, randomized studies are needed to compare bridging with LMWH to bridging with Heparin. 6( 55) Management of Antiplatelet Therapy During Left Ventricular Assist Device Support After Thrombo-Hemorrhagic Events M. Gallo , J.R. Trivedi, E.J. Birks, D. Abramov, M.S. Slaughter.  Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, KY. Purpose: Patients during left ventricular assist device (LVAD) support can present with hemorrhagic or thrombotic complications. The relation between hematologic complications and the antiplatelet therapy is uncertain during concomitant warfarin treatment. Aim of this study is to investigate the effect of change in antiplatelet therapy on thrombo-hemorrhagic events. Methods: Between April 2010 and June 2015, 176 patients supported by a LVAD for at least 6 months were included in a single center study. Patients were categorized into 3 groups: (1) high antiplatelet regimen (325mg), n= 80 (2) low antiplatelet regimen started after hemorrhagic complications (81mg), n= 67 (3) double antiplatelet therapy started after thrombotic complications, n= 29. Non-parametric tests and Kaplan-Meier curves were used to analyze differences between the groups at baseline and event free survival. Results: Patients requiring low antiplatelet therapy after a bleeding event were older (59.3±13.4 vs. 50.8±13.2 ,p= 0.007) compared to patients requiring dual therapy. The indications for low antiplatelet therapy were gastrointestinal bleeding(GI) (n= 41, 61%), hemorrhagic stroke (n= 10, 15%) and epistaxis (n= 5, 7%). Despite low antiplatelet therapy, 23% (n= 16) of patients had recurrent GI bleeding. Major indications for double antiplatelet therapy were pump thrombosis (n= 16, 55%) and coronary artery stent placement (n= 4, 13%). Freedom from major bleeding event at 1 year was comparable for groups 1, 2 and 3 respectively 96%, 97% and 91% (p= 0.421). Freedom from thrombotic events at 1 year was comparable for groups 1, 2 and 3 respectively 97%, 98% and 91% (p= 0.317) (Figure 1). Conclusion: Older patients are more prone to bleeding events with recurrence of GI bleeding despite low antiplatelet therapy. Young patients are more prone to thrombotic events. Reducing or increasing anti-thrombotic therapies in response to major thrombo-hemorrhagic events in LVAD patients is a safe strategy to try avoid recurrences.

6( 54) Bridging Anti-Coagulation with Low-Molecular-Weight Heparin in HVAD Patients - A Safe and Effective Option B. Schrage , J. Braetz, A. Bernhardt, M. Rybczynski, M. Barten, H. Reichenspurner, S. Blankenberg, H. Grahn.  University Heart Center Hamburg, Hamburg, Germany. Purpose: Anti-coagulation with Vitamin-K-antagonists is imperatively required to prevent thrombotic events in patients on left ventricular assist devices (LVAD). In the case of sub-therapeutic INR, Heparin is commonly used to bridge anticoagulation. However, its short half-life, instable metabolism and the need for intravenous treatment are major drawbacks of this approach which may lead to bleeding or insufficient anticoagulation. In this study, we sought to analyse the safety and efficacy of anti-coagulation bridging with low-molecular-weight Heparin (LMWH) as an alternative for HVAD patients. Methods: In a retrospective, single-centre study we analysed the usage of LMWH for anti-coagulation bridging in 14 consecutive HVAD patients with 27 bridging events. The LMWH Enoxaparin was used. Bridging was initiated for patients with insufficient INR (> 0.4 below target INR) until reestablishment of target INR. Results: Mean INR at presentation was 1.78 ± 0.34, mean Creatinine at presentation was 1.3 ±0.6 mg/dl. Mean duration of treatment were 2.78 ±1.8 days with a mean dose of 87.5 ± 46 mg Enoxaparin per day. There were two minor bleeding events (7.4%) during the Follow-up period (mean duration

6( 56) Prior Clotting Events as Predictors of Post LVAD Morbidity and Mortality J. Johannesen ,1 J. Whittier,2 S. Feitell,1 S.R. Hankins,2 W. Fischer,3 H.J. Eisen.2  1Medicine, Drexel University, Philadelphia, PA; 2Cardiology/ Medicine, Drexel University, Philadelphia, PA; 3Cardiothoracic Surgery, Drexel University, Philadelphia, PA. Purpose: Purpose: To determine if a past medical history of clotting can be used to predict adverse events post LVAD implantation. Background: Bleeding, pump thrombosis, and other thromboembolic events remain among the most feared post implantation complications for patients receiving LVADs. Despite this concern, a patient's coagulopathy history is rarely discussed when patients are presented as potential candidates for device

Abstracts S251 implantation. This project aims to determine if patients with previous histories of clotting are more prone to these post LVAD complications. Methods: Methods: A retrospective chart review of 46 patients who received Heartmate II LVADs from 2008-2013 in a single university transplant center was performed. These patients were sorted into those who had no history of clotting events and those who did. Clotting events included PE, DVT, LV/LA thrombus, thrombophlebitis and CVA. The two groups were then examined to determine which group suffered more post LVAD complications including hemorrhage, pump thrombosis, death within 6 months, stroke and MI. Results: Results: Of a total of 46 patients, 12 had a history of previous clot while 34 did not. Seventeen patients had an adverse event post LVAD implantation. Of those 17 patients, nine had a history of prior clot. In our analysis we found a significant relationship between history of clot and adverse LVAD outcome (p =  .004, OR 9.75, 95% CI 2.11-44.9). Conclusion: Conclusion: Despite a limited number of patients, our results were able to find a statistically meaningful difference in post LVAD complications between those patients with prior clotting events and those without. While future larger studies are warranted, these results would argue for different coagulation parameters in patients with histories of clotting. 6( 57) Antiphospholipid Syndrome in Patients with Left Ventricular Assist Device A. Al-Naamani ,1 A.L. Meyer,1 K. Jawad,1 J. Fischer,1 A. Siegemund,2 T. Siegemund,2 A. Oberbach,1 J. Hahn,1 S. Lehmann,1 F.W. Mohr,1 J. Garbade.1  1Leizpig Heart Center, Leizpig, Germany; 2MVZ Labor Leipzig, Leizpig, Germany. Purpose: Left ventricular assist device (LVAD) implantation is an established therapy in patients with end-stage heart failure. Limitations in the durability of these pumps include the development of pump thrombosis. Risk factors are multivariable. We wanted to evaluate the role of antiphospholipid antibodies in the development of a pump thrombosis. Methods: In a cross-sectional study 102 patients after LVAD implantation from our outpatient clinic were evaluated for an antiphospholipid syndrome. Serum samples were examined for IgG/IgM positivity in anticardiolipin, anti-β 2 glycoprotein I, lupus anticoagulant, annexin v, phosphatidylethanolamine, phosphatidylserine and prothrombin. Samples were measured on at least two separate occasions > 12 weeks apart. Antiphospholipid syndrome were determined if at least one of the antibodies were elevated in 2 or more occasions. Results: Of 102 patients 18 patients developed a pump thrombosis during a mean follow-up of 40±19 months. The mean age of the 97 male and 5 female patients was 60±12years. Implanted devices were HVAD (n= 74), HM II (n=  25), MVAD (n=  2) and HM 3 (n=  1). At least one of the antibodies was positive in 51% of the patients. An antiphospholipid syndrome was not significant more often in patients with a pump thrombosis (44% vs. 52%). A risk factor for an LVAD thrombosis was only a mechanical mitral valve (p= 0.002). Conclusion: Antiphospholipid antibodies are more often in patients after LVAD implantation than in the normal population. Patients with a pump thrombosis have not a significant higher rate of antiphospholipid antibodies. Therefore, a different or stronger anticoagulation is not necessary. 6( 58) Incidence of Gastrointestinal Bleeding and Acquired von Willebrand Syndrome in Japanese Recipients of Continuous-Flow Left Ventricular Assist Devices -Comparison Between Axial and Centrifugal-Flow Pumps S. Nakajima ,1 K. Kuroda,1 H. Sunami,1 T. Sato,1 O. Seguchi,1 M. Yanase,1 Y. Matsumoto,2 H. Hata,2 T. Fujita,2 J. Kobayashi,2 N. Fukushima.1  1Department of Transplant Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan; 2Department of Adult Cardiac Surgery, National Cerebral and Cardiovascular Center, Osaka, Japan. Purpose: Previous studies have shown that there was a significantly high rate of gastrointestinal bleeding (GIB) and acquired von Willebrand syndrome (AVWS) in recipients of left ventricular assist devices (LVAD) with an axialflow pumps (AFP). However, the actual incidences of GIB and AVWS in Japanese patients especially with centrifugal-flow pumps (CFP), and the risk factors for GIB, are still unclear.

Methods: Fifty-nine patients implanted with AFP-LVAD (HMII (n= 35), Jarvik 2000 (n= 9)), and CFP-LVAD (DuraHeart (n= 5), EVAHEART (n= 10)) between 2013 and 2016 in our institution were included in this study. GIB events, and von Willebrand factor (VWF) profiles after LVAD implantation were compared between AFP recipients (mean age 42.0 ± 13.2 year-old, 32 males, BSA 1.61 ± 0.19 m2) and CFP recipients(mean age 40.2 ± 11.8 year-old, 15 males, BSA 1.76 ± 0.13 m2). ImageJ software (National Institutes of Health) was used to calculate the large VWF multimer index. Results: The large VWF multimer index was significantly lower in AFP recipients than that in CFP recipients (50.7 (42.9-59.8) % vs 66.7 (55.080.6) %, p= 0.0005). 16 GIB episodes occurred in 11 AFP recipients while no GIB episodes occurred in CFP recipients. In AFP recipients, patients with GIB (n= 11) were significantly older and exhibited significantly lower large VWF multimer index than patients without GIB (n= 33) (54 (37-59) years old vs 44 (28-50) years old, p= 0.016; 41.7 (34.7-50.5) % vs 54.2 (46.0-60.7) %, p= 0.0062, respectively). Receiver operating characteristic curve analysis identified an age of 52 years old and a large VWF multimer index of 51% as the optimal cut-off value for predicting GIB (sensitivity 71.7 %, specificity 78.7%, AUC 0.74, and sensitivity 90.9%, specificity 60.6%, AUC 0.77, respectively). Multivariate logistic regression analysis revealed patients’ age (odds ratio [OR], 1.09; 95% confidence interval [CI], 1.01-1.20; p=  0.014) and Jarvik 2000 (OR, 9.45; 95% CI, 1.10-145.53; p= 0.039) as independent risk factors for GIB in AFP recipients. Conclusion: CFP recipients demonstrated the lower incidence of GIB and the milder forms of AVWS compared with AFP recipients. In AFP recipients, patients’ age and the device Jarvik 2000 were identified as risk factors for GIB. 6( 59) Examining Pump Exchange and Laboratory Markers of Organ Function Among LVAD Related Hospitalizations for Hemolytic Events G. Murtaza , T. Yousuf, C. Kabir, C. Desai.  UIC/Advocate Christ Medical Center, Oak Lawn, IL. Purpose: Heart Failure that is unresponsive to medical therapy is increasingly being treated with Left Ventricular Assist Device (LVAD). One of the common complications after device implant, pump hemolysis, which usually occurs due to VAD thrombosis, is associated with thromboembolic and/or thrombotic events and increased mortality that may result from cardiogenic shock. While anticoagulation plays a role, operative intervention (pump exchange) is definitive. We analyzed patients with pump hemolysis after LVAD placement to see if any association existed between peak Lactate Dehydrogenase (LDH) levels, other laboratory markers and the severity of hemolysis requiring pump exchange. Methods: We retrospectively analyzed LVAD HM II patients admitted to Advocate Christ Medical Center between 3/1/2005 and 12/31/2015. Among 504 patients, 573 durable continuous LVADs were implanted. Pump hemolysis was defined as LDH greater than 2.5 times its baseline value. Nonexchange hemolytic events vs. exchange hemolytic events were analyzed using χ 2 tests for independence for categorical variables and Student’s t-tests for continuous variables, with a threshold of two-sided p< 0.05 for statistical significance. Results: The prevalence of pump hemolysis amongst these LVAD patients was 7.5% (38/504). There were a total of 88 hemolysis events and 16 hemolytic events required pump exchanges. Mean LDH was found to be significantly higher during the hemolytic events requiring pump exchanges (M= 2913.9 U/L, SD= 1031.5) in comparison to events not requiring pump exchanges (M= 1799.3 U/L, SD= 904.9) (p<  .01). In addition, albumin was significantly lower in those with pump exchanges (M= 2.57, SD= 0.46) compared to non-exchange events (M= 2.95, SD= 0.52) (p= .02). Acute kidney injury (AKI), peak creatinine, B-type Natriuretic peptide (BNP), INR, and chronic kidney disease (CKD) were not statistically significantly associated with pump exchanges. Conclusion: Our results showed a statistically significant correlation between peak LDH levels and pump exchange with higher LDH levels necessitating a pump exchange. Albumin was found to be lower in those with pump exchange. AKI, peak creatinine, BNP, INR and CKD were not statistically significantly associated with pump exchanges.