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552 Are LVAD Support and Cardiac Transplantation Approaching Equipoise?
Abstracts
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complication. Programs engaged in implantation of continuous flow devices should have algorithms in place for management of devices undergoing thrombosis and be prepared to perform device exchange.
quality of life by maintaining necessary clinical resources in the local community while expanding the number of recipients.
550
Initial Experience – Cost Adjusted Quality of Life Years for Patients Supported by Ventricular Assist Devices for Destination Therapy Indication T.B. Icenogle,1,2 D. Sandler,1,2 A.A. Schmitt,1 D. Sato,1 J. Bjelkengren,1 S.A. Schaefer,1 S. Lewey.1 1Inland Northwest Thoracic Organ Transplant Program, Providence Sacred Heart Medical Center, Spokane, WA; 2Northwest Cardiothoracic & Transplant Surgeons, Spokane, WA.
0 to 60 in under 3 Years: Creating a Regional Referral Network To Grow a New VAD Center W.H. Perry,1 K.E. Nelson,1 J.W. Long,1 N.M. Chelikani,1 S.R. Clements,1 T.A. Snyder,1 B.V. Bogomilov,2 A.M. Kaneshige,3 H. Farhoud,4 C. Simpson,5 D.A. Horstmanshof.1 1Mechanical Circulatory Support, Integris Baptist Medical Center, Oklahoma City, OK; 2Walker Heart Institute Cardiovascular Clinic, Fayetteville, AR; 3 Oklahoma Heart Institute at Hillcrest Medical Center, Tulsa, OK; 4 Kansas Medical Center, Andover, KS; 5Mercy Heart and Vascular Center, Rogers, AR. Purpose: As ventricular assist device (VAD) therapy expands, implanting center cultivation of regional providers can provide avenues for growth. Our program covers 4 states and 620 sq mi; thus, outpatient follow-up inconveniences patients and their families, while straining implant center resources. Herein, we describe establishment of a regional VAD referral and support network. Methods and Materials: Partnership with referring centers involves obtaining clinician commitment, determining space requirements, and training local staff. Services provided to regional clinics include 24 hr phone support, equipment maintenance, assistance with procedures, reimbursement support, and weekly patient communication. Referring and implanting teams collaborate on challenging issues to allocate resources effectively.
551
Purpose: To calculate the cost adjusted quality of life years (QALYs) gained by patients supported by continuous flow ventricular assist devices (VADs) for Destination Therapy (DT) indication at a single center. Methods and Materials: Quality of life (QOL) scores obtained from the Minnesota Living with Heart Failure Questionnaires (MLHFQ) were collected at baseline and post-operative months (POM) 1, 3, 6, 12, 18, and 24 for DT patients on continuous flow VADs (n⫽10). Scores were scaled to fit a 0 to 1 outcome, with a score of 1 representing the best QOL possible. Costs were compiled from time of hospital admission for VAD implant to POM 24, per patient. Some patients did not reach POM 24, therefore interim costs were calculated to match the timescale for collecting QOL data. Two common methods were used for calculating a cost adjusted QALY. Method 1 divides total costs by life expectancy times QOL score improvement. Life expectancy data was pulled from actuarial life tables, or extrapolated from estimated Kaplan-Meier survival curves for DT patients to yield two variations of method 1. Method 2 for calculating cost adjusted QALYs divides total costs per year by the raw QOL score. Results: Preliminary results showed maximum QOL gains by POM 12, with a QOL score improvement of 0.36 (n⫽6). The average QOL score at POM 12 was 0.72, and average costs per patient were $368,577. The average QOL score by POM 24 was 0.73, and average costs per patient were $373,138 (n⫽3). This resulted in a cost adjusted QALY of $118,677 using method 1 and $256,596 using method 2. Additional data points will be incorporated into the data set and cost adjusted QALYs will be computed, as the original sample completes endpoints. Conclusions: Preliminary data show a clear improvement in QOL scores, which has been reported in other studies. Preliminary data also show a sizeable financial investment made by POM 12. Financial investments made between POM 12 and POM 24 were much smaller. 552
Results: We identified 7 follow-up clinics and 2 regional hospitals for general medical care, allowing our center to grow from 18 implants in 2008 to 50⫹ in 2011. As of Oct 2011, 120 VAD patients have been implanted at our center, with 74 on VAD support and 20-25% of patients receiving follow-up care at a regional clinic.
Are LVAD Support and Cardiac Transplantation Approaching Equipoise? R.M. Adamson,1 B. Jaski,2 P. Hoagland,2 J. Chammas,1 V. Norman,1 V. McCalmont,3 L. Hazard,3 K. Ortiz,3 S. Chillcott,3 M. Stahovich,3 W.P. Dembitsky.1 1Cardiothoracic Surgery, Sharp Memorial Hospital, San Diego, CA; 2Cardioloy, Sharp Memorial Hospital, San Diego, CA; 3 Nursing, Sharp Memorial Hospital, San Diego, CA. Purpose: Cardiac transplantation (Tx) is the standard of care for terminal heart failure although limited donor availability has made its impact epidemiologically trivial. Recent outcomes with the HeartMate II (HMII) have approached those of Tx making direct comparisons timely. Methods and Materials: All patients having a HMII implant (102) or Tx (59) at a single institution since 2006 were reviewed. Patient length of stay, survival, and hospital cost/procedure were compared. Results Summary HM II
Conclusions: Dissemination of VAD technology reduces the burden on the implanting center and, with careful management, can improve VAD patient
Male Age (years) LOS (days) Required bridge Cost Change
86% 62.9 22 8% ⫺41%
Tx 64% 51.6 18 33% ⫹17%
p-value p ⬍.001 p ⬍.05 NS p ⬍.05 p ⬍.05
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The Journal of Heart and Lung Transplantation, Vol 31, No 4S, April 2012
Results: Compared to Tx, HMII patients were older and more frequently male. Length of stay and survival to discharge were similar. Longer term survival favored Tx patients. Of all 98 patients listed for Tx during the study period, 32/98 (33%) required an LVAD for bridging to decision or transplant and overall 59/98 (60%) were transplanted of which 11/59 (19%) were on device at the time of transplant. Pre-LVAD mortality was 0/102 vs. pre-Tx mortality 15/98 (15%), p⬍.05. Post-operatively 9/28 (32%) HMII deaths were related to mechanical support whereas all 6/6 deaths in the Tx group were immunosuppression related.
HMII patients exhibited a 3.2 fold increase in MAC-1 expression to 18% at POD 14 (p⬍0.03) and remained elevated to POD 60 while for HW pts it stayed between 5% and 7% over the same period. Infection events peaked at 0.023 events/pt-day at 60 days for the HMII while the rate remained 0 for the HW out to 120 days. Conclusions: Alterations in WBC profiles and granulocyte activation experienced by LVAD pts may be device-specific. HMII pts experienced elevation of circulating granulocyte MAC-1 expression to POD 60, which was significantly higher than PVAD and HW patients. In contrast, HW pts exhibited very little granulocyte activation and experienced no infection events. Advances in LVAD design need to consider cellular-level interactions between the pump and the pt. 554 Safety of Discontinuation of Anticoagulation in Patients with Continuous-Flow LVADs F. Kamdar, P. Eckman, K. Liao, M. Colvin-Adams, R. John. University of Minnesota, Minneapolis, MN.
Conclusions: Disparity in outcomes and cost between LVADs and Tx have narrowed over time. However, equipoise is difficult to determined because LVAD patients are older with more associated non-cardiac comorbidities. 553 Temporal Leukocyte Profiles and Granulocyte Activation in LVAD Recipients R.L. Kormos,1 J.R. Woolley,2 K.L. Lockard,1 C. Bermudez,1 J.K. Bhama,1 J.J. Teuteberg,1 W.R. Wagner.2 1Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA; 2McGowan Institute for Regenerative Medicine, University of Pittsburgh, PA. Purpose: The impact of LVAD technology on cellular function is poorly reported. Rotary LVAD’s produce elevated shear stress which may effect leukocytes(WBC) and impact infection resistance. MAC-1 is an adhesion molecule expressed on stimulated granulocytes that mediates migration of the WBC from the circulation into inflamed tissue. No studies have presented comparative data on rotary and pulsatile LVAD patients(pt) for CD11b (MAC-1) expression on circulating granulocytes. Methods and Materials: Pts implanted with HeartMate II (HMII), HeartWare (HW) or Thoratec PVAD (PVAD) LVAD between 03/01/2009 to07/01/ 2010 were prospectively followed for up to 300 days of support. WBC counts and MAC-1 were measured using flow cytometry on post-operative day(POD) 14, 21, 30, and monthly thereafter until POD 300 or VAD cessation. Results: HMII and PVAD patients exhibited a significant peak in WBC counts and substantial upward trends in relative granulocyte concentration.
Purpose: Continuous-flow (CF) LVADs are an increasingly utilized therapy for end-stage heart failure given their efficacy and durability. However these devices require systemic anticoagulation and anti-platelet therapy, which can result in significant bleeding, occasionally warranting discontinuation of such therapy. The incidence and safety of stopping anticoagulation in CF LVAD patients is not well described. Methods and Materials: All patients who received CF LVADs at our institution between 6/2005 and 10/2011 were reviewed. Those patients whose antiplatelet therapy or anticoagulation was discontinued for at least 30 days were included in this analysis. Results: 213 patients received CF LVADs during this period. Of these, 10 patients had warfarin discontinued, 4 patients had both aspirin (ASA) and warfarin discontinued, and 12 patients had only ASA discontinued. The 14 patients that were off warfarin or warfarin and ASA had a mean age of 61 ⫾ 14 years, 79% were male and 79% had an ischemic etiology. The indication for discontinuing anticoagulation was significant gastrointestinal (GI) bleeding in all patients. Discontinuation of warfarin occurred at a mean duration of 381 days of LVAD support (range 9-1670 days). The mean duration off warfarin was 392 days (range 31 to 1980 days). The total cumulative time off warfarin was 15 patient-years. 5 patients have been off warfarin for at least 1 year. One patient had a thrombus due to device malposition requiring a device exchange after being off of warfarin for 1.3 years. There were no additional adverse events in these patients after discontinuing warfarin. Conclusions: Despite the successes of CF LVADs, adverse events such as GI bleeding may necessitate the discontinuation of anticoagulation therapy. However, the majority of these patients may tolerate discontinuation of anticoagulation therapy without an increased risk of adverse thromboembolic events. Understanding the biology of altered coagulation in patients receiving CF LVADs and strategies to further optimize anticoagulation is paramount to achieving further success.
S191
complication. Programs engaged in implantation of continuous flow devices should have algorithms in place for management of devices undergoing thrombosis and be prepared to perform device exchange.
quality of life by maintaining necessary clinical resources in the local community while expanding the number of recipients.
550
Initial Experience – Cost Adjusted Quality of Life Years for Patients Supported by Ventricular Assist Devices for Destination Therapy Indication T.B. Icenogle,1,2 D. Sandler,1,2 A.A. Schmitt,1 D. Sato,1 J. Bjelkengren,1 S.A. Schaefer,1 S. Lewey.1 1Inland Northwest Thoracic Organ Transplant Program, Providence Sacred Heart Medical Center, Spokane, WA; 2Northwest Cardiothoracic & Transplant Surgeons, Spokane, WA.
0 to 60 in under 3 Years: Creating a Regional Referral Network To Grow a New VAD Center W.H. Perry,1 K.E. Nelson,1 J.W. Long,1 N.M. Chelikani,1 S.R. Clements,1 T.A. Snyder,1 B.V. Bogomilov,2 A.M. Kaneshige,3 H. Farhoud,4 C. Simpson,5 D.A. Horstmanshof.1 1Mechanical Circulatory Support, Integris Baptist Medical Center, Oklahoma City, OK; 2Walker Heart Institute Cardiovascular Clinic, Fayetteville, AR; 3 Oklahoma Heart Institute at Hillcrest Medical Center, Tulsa, OK; 4 Kansas Medical Center, Andover, KS; 5Mercy Heart and Vascular Center, Rogers, AR. Purpose: As ventricular assist device (VAD) therapy expands, implanting center cultivation of regional providers can provide avenues for growth. Our program covers 4 states and 620 sq mi; thus, outpatient follow-up inconveniences patients and their families, while straining implant center resources. Herein, we describe establishment of a regional VAD referral and support network. Methods and Materials: Partnership with referring centers involves obtaining clinician commitment, determining space requirements, and training local staff. Services provided to regional clinics include 24 hr phone support, equipment maintenance, assistance with procedures, reimbursement support, and weekly patient communication. Referring and implanting teams collaborate on challenging issues to allocate resources effectively.
551
Purpose: To calculate the cost adjusted quality of life years (QALYs) gained by patients supported by continuous flow ventricular assist devices (VADs) for Destination Therapy (DT) indication at a single center. Methods and Materials: Quality of life (QOL) scores obtained from the Minnesota Living with Heart Failure Questionnaires (MLHFQ) were collected at baseline and post-operative months (POM) 1, 3, 6, 12, 18, and 24 for DT patients on continuous flow VADs (n⫽10). Scores were scaled to fit a 0 to 1 outcome, with a score of 1 representing the best QOL possible. Costs were compiled from time of hospital admission for VAD implant to POM 24, per patient. Some patients did not reach POM 24, therefore interim costs were calculated to match the timescale for collecting QOL data. Two common methods were used for calculating a cost adjusted QALY. Method 1 divides total costs by life expectancy times QOL score improvement. Life expectancy data was pulled from actuarial life tables, or extrapolated from estimated Kaplan-Meier survival curves for DT patients to yield two variations of method 1. Method 2 for calculating cost adjusted QALYs divides total costs per year by the raw QOL score. Results: Preliminary results showed maximum QOL gains by POM 12, with a QOL score improvement of 0.36 (n⫽6). The average QOL score at POM 12 was 0.72, and average costs per patient were $368,577. The average QOL score by POM 24 was 0.73, and average costs per patient were $373,138 (n⫽3). This resulted in a cost adjusted QALY of $118,677 using method 1 and $256,596 using method 2. Additional data points will be incorporated into the data set and cost adjusted QALYs will be computed, as the original sample completes endpoints. Conclusions: Preliminary data show a clear improvement in QOL scores, which has been reported in other studies. Preliminary data also show a sizeable financial investment made by POM 12. Financial investments made between POM 12 and POM 24 were much smaller. 552
Results: We identified 7 follow-up clinics and 2 regional hospitals for general medical care, allowing our center to grow from 18 implants in 2008 to 50⫹ in 2011. As of Oct 2011, 120 VAD patients have been implanted at our center, with 74 on VAD support and 20-25% of patients receiving follow-up care at a regional clinic.
Are LVAD Support and Cardiac Transplantation Approaching Equipoise? R.M. Adamson,1 B. Jaski,2 P. Hoagland,2 J. Chammas,1 V. Norman,1 V. McCalmont,3 L. Hazard,3 K. Ortiz,3 S. Chillcott,3 M. Stahovich,3 W.P. Dembitsky.1 1Cardiothoracic Surgery, Sharp Memorial Hospital, San Diego, CA; 2Cardioloy, Sharp Memorial Hospital, San Diego, CA; 3 Nursing, Sharp Memorial Hospital, San Diego, CA. Purpose: Cardiac transplantation (Tx) is the standard of care for terminal heart failure although limited donor availability has made its impact epidemiologically trivial. Recent outcomes with the HeartMate II (HMII) have approached those of Tx making direct comparisons timely. Methods and Materials: All patients having a HMII implant (102) or Tx (59) at a single institution since 2006 were reviewed. Patient length of stay, survival, and hospital cost/procedure were compared. Results Summary HM II
Conclusions: Dissemination of VAD technology reduces the burden on the implanting center and, with careful management, can improve VAD patient
Male Age (years) LOS (days) Required bridge Cost Change
86% 62.9 22 8% ⫺41%
Tx 64% 51.6 18 33% ⫹17%
p-value p ⬍.001 p ⬍.05 NS p ⬍.05 p ⬍.05
S192
The Journal of Heart and Lung Transplantation, Vol 31, No 4S, April 2012
Results: Compared to Tx, HMII patients were older and more frequently male. Length of stay and survival to discharge were similar. Longer term survival favored Tx patients. Of all 98 patients listed for Tx during the study period, 32/98 (33%) required an LVAD for bridging to decision or transplant and overall 59/98 (60%) were transplanted of which 11/59 (19%) were on device at the time of transplant. Pre-LVAD mortality was 0/102 vs. pre-Tx mortality 15/98 (15%), p⬍.05. Post-operatively 9/28 (32%) HMII deaths were related to mechanical support whereas all 6/6 deaths in the Tx group were immunosuppression related.
HMII patients exhibited a 3.2 fold increase in MAC-1 expression to 18% at POD 14 (p⬍0.03) and remained elevated to POD 60 while for HW pts it stayed between 5% and 7% over the same period. Infection events peaked at 0.023 events/pt-day at 60 days for the HMII while the rate remained 0 for the HW out to 120 days. Conclusions: Alterations in WBC profiles and granulocyte activation experienced by LVAD pts may be device-specific. HMII pts experienced elevation of circulating granulocyte MAC-1 expression to POD 60, which was significantly higher than PVAD and HW patients. In contrast, HW pts exhibited very little granulocyte activation and experienced no infection events. Advances in LVAD design need to consider cellular-level interactions between the pump and the pt. 554 Safety of Discontinuation of Anticoagulation in Patients with Continuous-Flow LVADs F. Kamdar, P. Eckman, K. Liao, M. Colvin-Adams, R. John. University of Minnesota, Minneapolis, MN.
Conclusions: Disparity in outcomes and cost between LVADs and Tx have narrowed over time. However, equipoise is difficult to determined because LVAD patients are older with more associated non-cardiac comorbidities. 553 Temporal Leukocyte Profiles and Granulocyte Activation in LVAD Recipients R.L. Kormos,1 J.R. Woolley,2 K.L. Lockard,1 C. Bermudez,1 J.K. Bhama,1 J.J. Teuteberg,1 W.R. Wagner.2 1Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA; 2McGowan Institute for Regenerative Medicine, University of Pittsburgh, PA. Purpose: The impact of LVAD technology on cellular function is poorly reported. Rotary LVAD’s produce elevated shear stress which may effect leukocytes(WBC) and impact infection resistance. MAC-1 is an adhesion molecule expressed on stimulated granulocytes that mediates migration of the WBC from the circulation into inflamed tissue. No studies have presented comparative data on rotary and pulsatile LVAD patients(pt) for CD11b (MAC-1) expression on circulating granulocytes. Methods and Materials: Pts implanted with HeartMate II (HMII), HeartWare (HW) or Thoratec PVAD (PVAD) LVAD between 03/01/2009 to07/01/ 2010 were prospectively followed for up to 300 days of support. WBC counts and MAC-1 were measured using flow cytometry on post-operative day(POD) 14, 21, 30, and monthly thereafter until POD 300 or VAD cessation. Results: HMII and PVAD patients exhibited a significant peak in WBC counts and substantial upward trends in relative granulocyte concentration.
Purpose: Continuous-flow (CF) LVADs are an increasingly utilized therapy for end-stage heart failure given their efficacy and durability. However these devices require systemic anticoagulation and anti-platelet therapy, which can result in significant bleeding, occasionally warranting discontinuation of such therapy. The incidence and safety of stopping anticoagulation in CF LVAD patients is not well described. Methods and Materials: All patients who received CF LVADs at our institution between 6/2005 and 10/2011 were reviewed. Those patients whose antiplatelet therapy or anticoagulation was discontinued for at least 30 days were included in this analysis. Results: 213 patients received CF LVADs during this period. Of these, 10 patients had warfarin discontinued, 4 patients had both aspirin (ASA) and warfarin discontinued, and 12 patients had only ASA discontinued. The 14 patients that were off warfarin or warfarin and ASA had a mean age of 61 ⫾ 14 years, 79% were male and 79% had an ischemic etiology. The indication for discontinuing anticoagulation was significant gastrointestinal (GI) bleeding in all patients. Discontinuation of warfarin occurred at a mean duration of 381 days of LVAD support (range 9-1670 days). The mean duration off warfarin was 392 days (range 31 to 1980 days). The total cumulative time off warfarin was 15 patient-years. 5 patients have been off warfarin for at least 1 year. One patient had a thrombus due to device malposition requiring a device exchange after being off of warfarin for 1.3 years. There were no additional adverse events in these patients after discontinuing warfarin. Conclusions: Despite the successes of CF LVADs, adverse events such as GI bleeding may necessitate the discontinuation of anticoagulation therapy. However, the majority of these patients may tolerate discontinuation of anticoagulation therapy without an increased risk of adverse thromboembolic events. Understanding the biology of altered coagulation in patients receiving CF LVADs and strategies to further optimize anticoagulation is paramount to achieving further success.