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564 Use of Novel Thrombosis Index of Risk (TIR) as Indicator for Left Ventricular Assist Device (LVAD) Thrombosis
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The Journal of Heart and Lung Transplantation, Vol 31, No 4S, April 2012
mechanical ventilation (25 vs. 4.5%, p ⫽ 0.019) or re-intubation (37.5 vs. 13.6%, p ⫽ 0.023). Mean blood pressure during the 2 months after LVAD implantation was significant lower in the Group N (80.6 ⫾ 5.9 vs. 84.6 ⫾ 5.9, p ⫽ 0.009). Multivariate analysis revealed that pre-operative pulmonary disease (odds ratio [OR], 4.65; 95% confidence interval [CI] 1.09 – 19.66, p ⫽ 0.037) and re-intubation (OR, 7.57; 95% CI, 1.04 – 55.2, p ⫽ 0.046) were independent predictors of poor renal restoration. Furthermore, one and half year survival was significantly lower for patients in the Group N (N: 29.5%, R: 62.3%, p ⫽ 0.044). Conclusions: Larger BMI, diabetes, respiratory insufficiency, and lower mean blood pressure while on device support contribute to poor renal recovery, which leads to compromised outcome. 564 Use of Novel Thrombosis Index of Risk (TIR) as Indicator for Left Ventricular Assist Device (LVAD) Thrombosis M. Sobieski, S. Schwartz, J.R. Trivedi, E.J. Birks, K.C. McCants, M.L. Williams, M.S. Slaughter. University of Louisville, Louisville, KY. Purpose: Left Ventricular Assist Device (LVAD), is an effective therapy for patients in advanced-stage heart failure, increasing patient survival and quality of life. LVADs are associated with risk of bleeding and thrombosis. We used LDH and BNP as biomarkers for indexing risk of thrombosis. Methods and Materials: Data from single center was retrospectively queried between 1/1/2008 and 8/15/2011 to identify LVAD patients and related complications. Of all 75 patients, 9 had device thrombosis. Analysis of the relationship between INR, BNP, LDH, and device thrombosis was performed. Results: Of 9 patients with thrombosis, 7 had at least 30% INR readings below therapeutic (⬍1.5) and 2 had at least 22% readings below therapeutic from the time of LVAD implant to date of thrombosis. Timeline variability (in a device thrombosis patient) in INR, BNP and LDH were used to calculate Thrombosis Index of Risk.
Figure 1 describes the timeline of LVAD placement, documented date of thrombosis and earliest evidence of increase in BNP and LDH. Conclusions: Indexed rise in BNP and LDH in LVAD patients may be useful to identify early device thrombosis. Fibrinogen and D-dimer assays are currently being evaluated in these patients for thrombosis activity. 565 Readmissions Following Implantation of Axial Flow Left Ventricular Assist Devices T. Hasin, Y. Marmor, Y. Topilsky, J.A. Schirger, B.A. Boilson, A.L. Clavell, R.J. Rodeheffer, R.P. Frantz, B.S. Edwards, N.L. Pereira, L. Joyce, D. Richard, S.J. Park, S.S. Kushwaha. Mayo Clinic, Rochester. Purpose: Based on the REMATCH experience, readmissions following left ventricular assist devices (LVAD) implantation are thought to be
frequent. We sought to determine the occurrence and causes of readmissions in our single center population. Methods and Materials: We retrospectively analyzed readmissions to our facility in a cohort of 99 patients, of whom 34 were bridge to transplant, implanted between February 2007 and June 2011 with the Heartmate II axial flow LVAD. Results: The patients were followed for 1.3⫾0.8 years. There were 179 readmissions in 68 patients with a readmission rate of 1.1 (0, 2.5) [median (25%, 75%)] per patient/year follow-up. Patients spent 6.2 (0, 15) days in the hospital per patient/year follow-up. Timing of readmission was 142 (56, 327) days after LVAD implant. Leading defined causes of readmission were gastrointestinal bleeding (40 returns in 25 patients), infections unrelated to pump (20 in 17 patients), ventricular arrhythmias (19 in 12 patients), other non-LVAD cardiac related readmissions (18 in 16 patients), other bleeding including cerebral bleeding (15 in 14 patients) and hemolysis (10 in 9 patients). Less frequent causes included biliary complications, pump parameter abnormalities, thromboembolic events, pacing device complications, supraventricular arrhythmias, pleural effusion, trauma and device infection. Conclusions: In conclusion readmission rates for recipients of axial flow LVAD are low. The leading cause is gastrointestinal bleeding followed by sepsis and cardiac (non-LVAD) complications. 566 Clinical Outcomes of Individualized Antiplatelet Therapy in Centrifugal Rotary Blood Pump Recipients A. Canteli, A. Stepanenko, N. Dranishnikov, E. Hennig, F. Kaufmann, J. Vierecke, B. Jurmann, T. Drews, H.B. Lehmkuhl, Y. Weng, M. Pasic, E.V. Potapov, T. Krabatsch, R. Hetzer. Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, Berlin, Germany. Purpose: Antiplatelet therapy (anti-PLT)routinely follows oral anticoagulation in rotary blood pump recipients. However, in the long-term course, withdrawal of Aspirin due to bleeding events is required in some patients. Our study evaluated thromboembolic (TE) and bleeding events (BE) and their relationship to regimes of antiplatelet therapy. Methods and Materials: We included 84 patients with implantation of HeartWare HVAD between 08/2009 and 10/2011 and still on support at latest follow-up of 1.11.11. All TE and BE episodes after initial discharge and data at time of event, anticoagulation regime, laboratory data and other factors were retrospectively analyzed. Results: Cumulative follow-up is 85.7 pt/years; anti-PLT is shown in table 1. Cumulative rate for any BE was 0.17 events per pt/year and for any TE 0.10 events per pt/year. 24 events in 20 pts were observed. BE: epistaxis n⫽10, gastrointestinal n⫽3, intracranial bleeding n⫽2. TE: transitory ischemic attack n⫽7, stroke n⫽1, and pump thrombosis n⫽1. Median time for cumulative event onset was 217 days (range 14-554). Four of 9 TE occurred in absence of any anti-PLT and 5 under ASA, in 4 cases in association with dipyridamol. In 4 BE cases, patients had been free of any anti-PLT; 11 others episodes occurred on ASA therapy, in 10 in combination with dipyridamol. International normalized ratio was in therapeutic range in 23 of 24 cases. Table 1
Antiplatelet therapy course DISCHARGE, n⫽84
6 MONTHS, n⫽77
1 YEAR, n⫽53
2 YEARS, n⫽19
ANTIPLATELET AGENTS
% (mg, median)
% (mg, median)
% (mg, median)
% (mg, median)
ASA
69 (25)
70 (25)
64 (25)
58 (50)
DIPYRIDAMOL
61 (200)
57 (200)
57 (200)
37 (200)
CLOPIDOGREL
2 (56)
2.6 (56.25)
1.8 (37.5)
5.2 (37.5)
FOLLOW-UP:
Conclusions: We observed in centrifugal pump recipients more bleeding episodes than thromboembolism despite relatively low aggressivity of our institutional anti-PLT protocol. It seems that event onset is not related to INR level. Individualized antiplatelet therapy is safe for long-term thromboembolic/bleeding event free support.
The Journal of Heart and Lung Transplantation, Vol 31, No 4S, April 2012
mechanical ventilation (25 vs. 4.5%, p ⫽ 0.019) or re-intubation (37.5 vs. 13.6%, p ⫽ 0.023). Mean blood pressure during the 2 months after LVAD implantation was significant lower in the Group N (80.6 ⫾ 5.9 vs. 84.6 ⫾ 5.9, p ⫽ 0.009). Multivariate analysis revealed that pre-operative pulmonary disease (odds ratio [OR], 4.65; 95% confidence interval [CI] 1.09 – 19.66, p ⫽ 0.037) and re-intubation (OR, 7.57; 95% CI, 1.04 – 55.2, p ⫽ 0.046) were independent predictors of poor renal restoration. Furthermore, one and half year survival was significantly lower for patients in the Group N (N: 29.5%, R: 62.3%, p ⫽ 0.044). Conclusions: Larger BMI, diabetes, respiratory insufficiency, and lower mean blood pressure while on device support contribute to poor renal recovery, which leads to compromised outcome. 564 Use of Novel Thrombosis Index of Risk (TIR) as Indicator for Left Ventricular Assist Device (LVAD) Thrombosis M. Sobieski, S. Schwartz, J.R. Trivedi, E.J. Birks, K.C. McCants, M.L. Williams, M.S. Slaughter. University of Louisville, Louisville, KY. Purpose: Left Ventricular Assist Device (LVAD), is an effective therapy for patients in advanced-stage heart failure, increasing patient survival and quality of life. LVADs are associated with risk of bleeding and thrombosis. We used LDH and BNP as biomarkers for indexing risk of thrombosis. Methods and Materials: Data from single center was retrospectively queried between 1/1/2008 and 8/15/2011 to identify LVAD patients and related complications. Of all 75 patients, 9 had device thrombosis. Analysis of the relationship between INR, BNP, LDH, and device thrombosis was performed. Results: Of 9 patients with thrombosis, 7 had at least 30% INR readings below therapeutic (⬍1.5) and 2 had at least 22% readings below therapeutic from the time of LVAD implant to date of thrombosis. Timeline variability (in a device thrombosis patient) in INR, BNP and LDH were used to calculate Thrombosis Index of Risk.
Figure 1 describes the timeline of LVAD placement, documented date of thrombosis and earliest evidence of increase in BNP and LDH. Conclusions: Indexed rise in BNP and LDH in LVAD patients may be useful to identify early device thrombosis. Fibrinogen and D-dimer assays are currently being evaluated in these patients for thrombosis activity. 565 Readmissions Following Implantation of Axial Flow Left Ventricular Assist Devices T. Hasin, Y. Marmor, Y. Topilsky, J.A. Schirger, B.A. Boilson, A.L. Clavell, R.J. Rodeheffer, R.P. Frantz, B.S. Edwards, N.L. Pereira, L. Joyce, D. Richard, S.J. Park, S.S. Kushwaha. Mayo Clinic, Rochester. Purpose: Based on the REMATCH experience, readmissions following left ventricular assist devices (LVAD) implantation are thought to be
frequent. We sought to determine the occurrence and causes of readmissions in our single center population. Methods and Materials: We retrospectively analyzed readmissions to our facility in a cohort of 99 patients, of whom 34 were bridge to transplant, implanted between February 2007 and June 2011 with the Heartmate II axial flow LVAD. Results: The patients were followed for 1.3⫾0.8 years. There were 179 readmissions in 68 patients with a readmission rate of 1.1 (0, 2.5) [median (25%, 75%)] per patient/year follow-up. Patients spent 6.2 (0, 15) days in the hospital per patient/year follow-up. Timing of readmission was 142 (56, 327) days after LVAD implant. Leading defined causes of readmission were gastrointestinal bleeding (40 returns in 25 patients), infections unrelated to pump (20 in 17 patients), ventricular arrhythmias (19 in 12 patients), other non-LVAD cardiac related readmissions (18 in 16 patients), other bleeding including cerebral bleeding (15 in 14 patients) and hemolysis (10 in 9 patients). Less frequent causes included biliary complications, pump parameter abnormalities, thromboembolic events, pacing device complications, supraventricular arrhythmias, pleural effusion, trauma and device infection. Conclusions: In conclusion readmission rates for recipients of axial flow LVAD are low. The leading cause is gastrointestinal bleeding followed by sepsis and cardiac (non-LVAD) complications. 566 Clinical Outcomes of Individualized Antiplatelet Therapy in Centrifugal Rotary Blood Pump Recipients A. Canteli, A. Stepanenko, N. Dranishnikov, E. Hennig, F. Kaufmann, J. Vierecke, B. Jurmann, T. Drews, H.B. Lehmkuhl, Y. Weng, M. Pasic, E.V. Potapov, T. Krabatsch, R. Hetzer. Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, Berlin, Germany. Purpose: Antiplatelet therapy (anti-PLT)routinely follows oral anticoagulation in rotary blood pump recipients. However, in the long-term course, withdrawal of Aspirin due to bleeding events is required in some patients. Our study evaluated thromboembolic (TE) and bleeding events (BE) and their relationship to regimes of antiplatelet therapy. Methods and Materials: We included 84 patients with implantation of HeartWare HVAD between 08/2009 and 10/2011 and still on support at latest follow-up of 1.11.11. All TE and BE episodes after initial discharge and data at time of event, anticoagulation regime, laboratory data and other factors were retrospectively analyzed. Results: Cumulative follow-up is 85.7 pt/years; anti-PLT is shown in table 1. Cumulative rate for any BE was 0.17 events per pt/year and for any TE 0.10 events per pt/year. 24 events in 20 pts were observed. BE: epistaxis n⫽10, gastrointestinal n⫽3, intracranial bleeding n⫽2. TE: transitory ischemic attack n⫽7, stroke n⫽1, and pump thrombosis n⫽1. Median time for cumulative event onset was 217 days (range 14-554). Four of 9 TE occurred in absence of any anti-PLT and 5 under ASA, in 4 cases in association with dipyridamol. In 4 BE cases, patients had been free of any anti-PLT; 11 others episodes occurred on ASA therapy, in 10 in combination with dipyridamol. International normalized ratio was in therapeutic range in 23 of 24 cases. Table 1
Antiplatelet therapy course DISCHARGE, n⫽84
6 MONTHS, n⫽77
1 YEAR, n⫽53
2 YEARS, n⫽19
ANTIPLATELET AGENTS
% (mg, median)
% (mg, median)
% (mg, median)
% (mg, median)
ASA
69 (25)
70 (25)
64 (25)
58 (50)
DIPYRIDAMOL
61 (200)
57 (200)
57 (200)
37 (200)
CLOPIDOGREL
2 (56)
2.6 (56.25)
1.8 (37.5)
5.2 (37.5)
FOLLOW-UP:
Conclusions: We observed in centrifugal pump recipients more bleeding episodes than thromboembolism despite relatively low aggressivity of our institutional anti-PLT protocol. It seems that event onset is not related to INR level. Individualized antiplatelet therapy is safe for long-term thromboembolic/bleeding event free support.