- Email: [email protected]
235 Thrombus within the HeartMate II Left Ventricular Assist Device (LVAD): Are All Clots Created Equal?
Abstracts patients 60-69 years old, careful selection in this higher risk cohort is warranted given these outcomes. 232 Improvement in Blood Sugar Control and Insulin Requirements in Patients with a Ventricular Assist Device K.L. Eleuteri, C.D. Kline, A. El-Banayosy, W. Pae, S. Behzad, E. Stephenson. Penn State Milton S. Hershey Medical Center, Hershey, PA. Purpose: Heart failure is associated with persistent sympathetic stimulation and inflammation, causing an induced insulin resistance creating a need for higher doses of insulin. We hypothesized that cortisol and chatecholamine levels would be elevated in end stage heart failure patients, however, would be reduced after the implantation of a left ventricular assist device (LVAD). Insulin requirements and diabetic control would also be reduced post LVAD implant. Methods and Materials: Pre- and postoperative cortisol, catecholamine, glycolated hemoglobin (HbA1c) and blood glucose levels were evaluated retrospectively in 97 LVAD patients at our facility from January 2007 through November 2011. Serum was collected before and after LVAD implantation. Results were evaluated and compared to insulin requirements before and after implant. Results: There were a total of 97 continuous flow LVAD patients, 79 male and 18 female. The mean age was 59 years, ⫾ 10. Total patient years of support were 92.5. 28 patients had Type II diabetes mellitus. Of those patients, 24 required insulin with an average daily dose of 45 units/day. Average preoperative HbA1c levels were 6.8% with fasting blood sugar (FBS) measurements of 136 mg/dL. Mean cortisol levels were measured at 24.3 g/dL preop with mean plasma chatecholamine levels of 1824. Post operatively, average HbA1c levels were 5.38%,FBS of 122 mg/dL, mean cortisol levels of 10.9 g/dL with average plasma chatecholamine levels of 815. There was a significant decrease in both cortisol levels post LVAD implant (p⫽0.012) and chatecholamine levels (p⫽0.044). Average daily insulin requirements post LVAD implant was significantly reduced to 13 units/day (p⫽0.001). Six (6) patients no longer required any insulin after implant. Conclusions: Frequently, diabetes is a co morbid condition that exists amongst heart failure patients. With LVAD support, many patients can see a reduction in their blood glucose levels as well as insulin requirements. 233 Contemporary Continuous Flow Devices: How Much Does It Cost To Keep a Patient on Support for One Year? D.J. Goldstein, A. Sileo, L. Baker, K. Vandevoort, P. Cotter. Cardiothoracic Surgery, Montefiore Medical Center, Bronx, NY. Purpose: With comprehensive health care cost cutting measures on the horizon, growing use of costly interventions like left ventricular assist devices (LVAD) gains increasing importance. Little is known about the cost of maintaining patients alive for 1 year after implantation of a contemporary LVAD. We sought to calculate total costs associated with contemporary LVAD support at an urban tertiary academic medical center. Methods and Materials: 20 consecutive LVAD recipients who lived at least 1 year on support were selected. Costs were divided into pre-implant, implant, post-implant and post-discharge and included all medical costs (direct and indirect), including readmissions, for 1 year following date of implant. Charges were converted to costs using hospital-specific cost-to-charge ratios. Results: Pre-implant hospitalization costs for the 20 patients averaged $46,141 ⫾ 35,087, with 66% of total pre-implant cost drivers related to room/board and professional fees. Median pre-implant length of stay was 7.5 days. Total implant day costs were $2,907,347 or 32% of total yearly costs and mostly due to cost of device and surgical supplies. Median post-implant length of stay was 23 days (range 13-113). 85% of patients were readmitted during the 1st year at a mean time of 53 ⫾ 69 days following index discharge. Total costs associated with 1st readmission were $269,121.There were 37 readmissions during 1-year f/up. Mean total costs for the 20 patients was $449,591 ($268,543 – 857,585). One-year total costs from day of implant totaled $8,068,994. Patients enjoyed 6022/7300 (82%) days out of hospital (OOH) at a total cost of $1105/day of support. Conclusions: LVAD support is associated with prolonged index hospitalization, frequent readmission and high costs. Nonetheless, LVAD recipients
S85 enjoy 82% of their 1st year OOH. Efforts to decrease total costs should focus on outpatient pre-implant optimization and reduction of readmissions. Future availability of more approved devices may reduce implant costs. 234 Allosensitization Associated with Continuous Axial Flow Left Ventricular Assist Device Implantation Does Not Affect Outcomes after Heart Transplantation N. Shankar, J. Geske, M. Gandhi, M. Timmons, B. Boilson, J. Schirger, A. Clavell, R. Frantz, R. Rodeheffer, R. Daly, L. Joyce, B. Edwards, W. Kremers, S.K. Kushwaha, S. Park, N.L. Pereira. Mayo Clinic, Rochester, MN. Purpose: Left ventricular assist devices (LVAD) used as a bridge to heart transplantation (BTT) may be limited by the formation of anti-HLA antibodies. Despite patients undergoing heart transplantation (HTX) by means of virtual crossmatch (VXM) there has been no data published to date on sensitization associated with LVAD implant as assessed by solid phase arrays. Methods and Materials: Both panel reactive antibody (PRA) and solid phase Single Antigen Bead (SAB) assay were analyzed in all HTX recipients undergoing LVAD implant as a BTT. Sensitization was defined as peak anti-HLA antibody titers, mean fluorescent intensity⬎2000. Results: There were 30 patients who had LVADs implanted as BTT. Types of devices included HeartMate II 67 % (20/30), VentrAssist 20%(6/ 30), and Jarvik 2000 13%(4/30). The mean duration of support was 264⫾36 days. There were 7 % (2/30) of patients prior to and no patients after LVAD implant with PRA ⬎10%. However, 20 % (6/30) of the population prior to and 53 % (16/30) after LVAD were sensitized as measured by SAB. At the time of HTX 47 % (14/30) of patients remained sensitized. Using anti-HLA antibody titers ⬎ 2000, a positive VXM was seen in 28 % (4/14) of the sensitized and none in the non-sensitized patients. There was no difference in the total usage of blood products (64⫾11 vs. 63⫾39 units) and time to HTX (286⫾63 vs. 257⫾48 days) and after HTX at 1 year, there were no differences in rejection (total rejection score 0.30 vs. 0.37) and survival (93% vs. 88%) between the sensitized and non-sensitized groups (p⬎0.4 for all). Conclusions: This is the first study to characterize the presence of antiHLA antibodies prior to and after continuous axial flow LVAD implant as measured by SAB assays. Sensitization as measured by SAB after LVAD is common despite PRA being negative resulting in a positive VXM in significant number of HTX recipients. However, this sensitization does not translate into increased rejection rates or reduced survival. 235 Thrombus within the HeartMate II Left Ventricular Assist Device (LVAD): Are All Clots Created Equal? I.D. Ledford, M. Labedi, A.G. Kfoury, J. Stehlik, R. Alharethi, B.B. Reid, D. Budge, C.H. Selzman, M.P. Revelo, S. Stoker, F. Bader, D.V. Miller. UTAH Cardiac Transplant Program, Salt Lake City, UT. Purpose: Thrombus formation within the LVAD circuit can be a devastating complication, but is fortunately rare. Clinically, clots are generally of two types: nonocclusive with embolic potential and occlusive with pump failure. In this study, an in-depth morphologic analysis of the composition of these clots at the tissue and cell level provides important clues to their formation and propagation. Methods and Materials: Included were patients with pump replacement for clinically manifest clots and incidental clots found during LVAD explant at the time of cardiac transplant. Clinical data and clot descriptions were reviewed. Available clot tissue was submitted for routine histology and portions prepared for transmission electron microscopy. Results: Among 130 patients with HeartMate II in our program, 10 (7.7%) developed clots in the LVAD circuit. Clinically, these were insidious (9) or catastrophic (1) in presentation. Representative clot tissue from each clinical type was examined. The 1st were non-occlusive, generally appeared white, firm, and brittle (Figure - Left) and were comprised of amorphous debris with aggregated platelets. The 2nd clot was occlusive red, soft, and more gelatinous (Figure - Right); comprised largely of fibrin mesh with entrapped blood elements. Conclusions: In this limited in-depth analysis, it appears that small white
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clots derive primarily from heat induced coagulation likely generated by LVAD speed ramping, whereas large occlusive red clots result from triggering of the coagulation cascade and formation/propagation of a fibrin meshwork. This new insight may help in shaping future preventive and therapeutic measures for this potentially devastating complication.
and 18 female, with a mean age of 59 ⫾10 yrs. and a median of 63 yrs. 62 patients had an ischemic cardiomyopathy and 35 patients had a dilated cardiomyopathy. Total patient years of LVAD support was 92.5 yrs. There was a significant difference in LVSD and LVEDD of both devices preoperatively and postoperatively at 3 months (LVSD p⫽.029, LVEDD p⫽.054) and at 6 months (LVSD p⫽.010, LVEDD p⫽ .014). There was a reduction of BNP by 675% in Heartmate II patients and a 368% BNP reduction in HeartWare patients.
236 Left Ventricular Assist Device Exchange Due to Driveline Failure after 1 Year of Support: Incidence, Operative Technique and Clinical Outcomes. Single-Center Experience A. Stepanenko, N. Dranishnikov, E. Hennig, F. Kaufmann, J. Vierecke, B. Jurmann, T. Drews, H. Lehmkuhl, Y. Weng, M. Pasic, E.V. Potapov, T. Krabatsch, R. Hetzer. Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum Berlin, Berlin, Germany. Purpose: In the last decade the duration of support in patients treated with left ventricle assist devices (LVAD) significantly increased. Consequently, patients are at risk of driveline damage requiring emergency surgical treatment (pump exchange, explantation or heart transplantation). Methods and Materials: We evaluate incidence of driveline damage, surgical therapy options and clinical outcomes in total of 153 patients who were supported for over 1 year with rotary blood pumps (Incor I, n⫽63 HeartMate II, n⫽57, DuraHeart, n⫽7, HeartWare, n⫽26) implanted at our institution. Results: In a total of 17 patients supported with different rotary pumps (Incor I, n⫽7; HeartMate II, n⫽8 and DuraHeart, n⫽2) driveline damage occurred at a median of 886 days (range 351-1471). The median age was 58 (range 28-74) years, one of them female. Two patients with intermittent device malfunction received heart transplantation; in 13 others the device was exchanged (5 with cardiopulmonary bypass and 8 without). One patient died before device exchange and in one the device was explanted after 763 days showing myocardial recovery. In two patients temporary RVAD support was necessary for 18 and 4 days. There was no perioperative mortality. Two late deaths occurred on postoperative days 48 and 53 due to sepsis and one further patient died at home 281 days after pump exchange. Conclusions: Pump exchange or heart transplantation in eligible candidates is a life-saving procedure with acceptable clinical outcomes for patients who suffer driveline failure. Regular evaluation of technical components including X-ray of the intracorporeal driveline after 1 year of support may early identify driveline damage. 237 Reverse Remodeling (RR) Following Rotary Blood Pump Implantation: Is There a Difference between Axial (AFP) and Centrifugal Flow Pumps (CFP)? K.L. Eleuteri, B. Soleimani, C. Brehm, E. Stephenson, W. Pae, A. El-Banayosy. Penn State Milton S. Hershey Medical Center, Hershey, PA. Purpose: Little is known about the effects of rotary flow pumps on RR and if whether there are any differences between AFP versus CFP. To study this, we performed a retrospective review of 97 patients implanted with rotary blood pumps between Jun 2006 and November 2011. Methods and Materials: Blinded LVEDD and LVSD readings were measured before and after implant, and at 3 and 6 months. LVAD speed was optimized in all patients by assuring complete closure of the aortic valve with the ventricular septum in the midline. BNP measurements were also performed at the same intervals. Results: 82 patients were implanted with an AFP, Thoratec Heartmate II®(HMII), and 15 with a CFP, HeartWare LVAS® (HW); 79 were male
Conclusions: RR has been demonstrated in both types of pumps. The extent of RR was more significant with the Heartmate II as compared to the HeartWare device. Inflow cannula diameter and gap size may contribute to RR differences. This data may be useful in identifying potential Bridge to Recovery (BTR) patients. Additional data and further evaluation is required to confirm these results. 238 Driveline Staging System: Help in Managing Acute and Chronic Driveline Infections K.L. Eleuteri, A. El-Banayosy, W. Suzanne. Mechanical Circulatory Support, Heart and Vascular Institute, Penn State Milton S. Hershey Medical Center, Hershey, PA. Purpose: Despite advances in LVAD technology with smaller pumps and drivelines, infections continue to be a challenge. We developed a Driveline Grading System algorithm to target and initiate appropriate treatments based on severity and type of infection. Methods and Materials: Between January 2006 and November 1, 2011, we implanted 97 patients (79 men, 18 women with a mean age of 59 years ⫾ 10) with continuous flow left ventricular assist devices; 82 Heartmate II and 15 HeartWare LVAS. We developed a Driveline Grading System based on severity of infection (clinical observation, amount of drainage, and positive wound cultures). We also initiated a new LVAD Driveline Management Kit which included all required supplies, including 2 forms of driveline securement to alleviate driveline exit site trauma and provide early driveline incorporation. Staff and family education included the use of a mannequin for supervised LVAD driveline dressing changes. Results: The mean duration of LVAD support was 3359 days, ⫾ 340 (median 239.5 days). Total patient years on mechanical support were 92.5. 32 patients were bridge to transplantation (BTT), 21 patients were bridge to candidacy (BTC), and 46 patients were destination therapy (DT). Prior to July, 2009, 12 out of 33 patients had a documented driveline infection (36%). After July 2009, we implemented our Driveline Grading System and began using our new kits on a total of 66 patients through November 2011. Our driveline infection rate improved to16%. This illustrated a significant decrease in driveline infection rates, p⫽ 0.04. Conclusions: Although LVAD complications continue to be an hindrance with MCS patients, meticulous care and management of the LVAD driveline has helped to lower infection rates and prevent further mortality and morbidity. A Driveline Infection Grading System can be used to guide the management of driveline infections and to assist with the reduction in overall LVAD driveline infections.
S85 enjoy 82% of their 1st year OOH. Efforts to decrease total costs should focus on outpatient pre-implant optimization and reduction of readmissions. Future availability of more approved devices may reduce implant costs. 234 Allosensitization Associated with Continuous Axial Flow Left Ventricular Assist Device Implantation Does Not Affect Outcomes after Heart Transplantation N. Shankar, J. Geske, M. Gandhi, M. Timmons, B. Boilson, J. Schirger, A. Clavell, R. Frantz, R. Rodeheffer, R. Daly, L. Joyce, B. Edwards, W. Kremers, S.K. Kushwaha, S. Park, N.L. Pereira. Mayo Clinic, Rochester, MN. Purpose: Left ventricular assist devices (LVAD) used as a bridge to heart transplantation (BTT) may be limited by the formation of anti-HLA antibodies. Despite patients undergoing heart transplantation (HTX) by means of virtual crossmatch (VXM) there has been no data published to date on sensitization associated with LVAD implant as assessed by solid phase arrays. Methods and Materials: Both panel reactive antibody (PRA) and solid phase Single Antigen Bead (SAB) assay were analyzed in all HTX recipients undergoing LVAD implant as a BTT. Sensitization was defined as peak anti-HLA antibody titers, mean fluorescent intensity⬎2000. Results: There were 30 patients who had LVADs implanted as BTT. Types of devices included HeartMate II 67 % (20/30), VentrAssist 20%(6/ 30), and Jarvik 2000 13%(4/30). The mean duration of support was 264⫾36 days. There were 7 % (2/30) of patients prior to and no patients after LVAD implant with PRA ⬎10%. However, 20 % (6/30) of the population prior to and 53 % (16/30) after LVAD were sensitized as measured by SAB. At the time of HTX 47 % (14/30) of patients remained sensitized. Using anti-HLA antibody titers ⬎ 2000, a positive VXM was seen in 28 % (4/14) of the sensitized and none in the non-sensitized patients. There was no difference in the total usage of blood products (64⫾11 vs. 63⫾39 units) and time to HTX (286⫾63 vs. 257⫾48 days) and after HTX at 1 year, there were no differences in rejection (total rejection score 0.30 vs. 0.37) and survival (93% vs. 88%) between the sensitized and non-sensitized groups (p⬎0.4 for all). Conclusions: This is the first study to characterize the presence of antiHLA antibodies prior to and after continuous axial flow LVAD implant as measured by SAB assays. Sensitization as measured by SAB after LVAD is common despite PRA being negative resulting in a positive VXM in significant number of HTX recipients. However, this sensitization does not translate into increased rejection rates or reduced survival. 235 Thrombus within the HeartMate II Left Ventricular Assist Device (LVAD): Are All Clots Created Equal? I.D. Ledford, M. Labedi, A.G. Kfoury, J. Stehlik, R. Alharethi, B.B. Reid, D. Budge, C.H. Selzman, M.P. Revelo, S. Stoker, F. Bader, D.V. Miller. UTAH Cardiac Transplant Program, Salt Lake City, UT. Purpose: Thrombus formation within the LVAD circuit can be a devastating complication, but is fortunately rare. Clinically, clots are generally of two types: nonocclusive with embolic potential and occlusive with pump failure. In this study, an in-depth morphologic analysis of the composition of these clots at the tissue and cell level provides important clues to their formation and propagation. Methods and Materials: Included were patients with pump replacement for clinically manifest clots and incidental clots found during LVAD explant at the time of cardiac transplant. Clinical data and clot descriptions were reviewed. Available clot tissue was submitted for routine histology and portions prepared for transmission electron microscopy. Results: Among 130 patients with HeartMate II in our program, 10 (7.7%) developed clots in the LVAD circuit. Clinically, these were insidious (9) or catastrophic (1) in presentation. Representative clot tissue from each clinical type was examined. The 1st were non-occlusive, generally appeared white, firm, and brittle (Figure - Left) and were comprised of amorphous debris with aggregated platelets. The 2nd clot was occlusive red, soft, and more gelatinous (Figure - Right); comprised largely of fibrin mesh with entrapped blood elements. Conclusions: In this limited in-depth analysis, it appears that small white
S86
The Journal of Heart and Lung Transplantation, Vol 31, No 4S, April 2012
clots derive primarily from heat induced coagulation likely generated by LVAD speed ramping, whereas large occlusive red clots result from triggering of the coagulation cascade and formation/propagation of a fibrin meshwork. This new insight may help in shaping future preventive and therapeutic measures for this potentially devastating complication.
and 18 female, with a mean age of 59 ⫾10 yrs. and a median of 63 yrs. 62 patients had an ischemic cardiomyopathy and 35 patients had a dilated cardiomyopathy. Total patient years of LVAD support was 92.5 yrs. There was a significant difference in LVSD and LVEDD of both devices preoperatively and postoperatively at 3 months (LVSD p⫽.029, LVEDD p⫽.054) and at 6 months (LVSD p⫽.010, LVEDD p⫽ .014). There was a reduction of BNP by 675% in Heartmate II patients and a 368% BNP reduction in HeartWare patients.
236 Left Ventricular Assist Device Exchange Due to Driveline Failure after 1 Year of Support: Incidence, Operative Technique and Clinical Outcomes. Single-Center Experience A. Stepanenko, N. Dranishnikov, E. Hennig, F. Kaufmann, J. Vierecke, B. Jurmann, T. Drews, H. Lehmkuhl, Y. Weng, M. Pasic, E.V. Potapov, T. Krabatsch, R. Hetzer. Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum Berlin, Berlin, Germany. Purpose: In the last decade the duration of support in patients treated with left ventricle assist devices (LVAD) significantly increased. Consequently, patients are at risk of driveline damage requiring emergency surgical treatment (pump exchange, explantation or heart transplantation). Methods and Materials: We evaluate incidence of driveline damage, surgical therapy options and clinical outcomes in total of 153 patients who were supported for over 1 year with rotary blood pumps (Incor I, n⫽63 HeartMate II, n⫽57, DuraHeart, n⫽7, HeartWare, n⫽26) implanted at our institution. Results: In a total of 17 patients supported with different rotary pumps (Incor I, n⫽7; HeartMate II, n⫽8 and DuraHeart, n⫽2) driveline damage occurred at a median of 886 days (range 351-1471). The median age was 58 (range 28-74) years, one of them female. Two patients with intermittent device malfunction received heart transplantation; in 13 others the device was exchanged (5 with cardiopulmonary bypass and 8 without). One patient died before device exchange and in one the device was explanted after 763 days showing myocardial recovery. In two patients temporary RVAD support was necessary for 18 and 4 days. There was no perioperative mortality. Two late deaths occurred on postoperative days 48 and 53 due to sepsis and one further patient died at home 281 days after pump exchange. Conclusions: Pump exchange or heart transplantation in eligible candidates is a life-saving procedure with acceptable clinical outcomes for patients who suffer driveline failure. Regular evaluation of technical components including X-ray of the intracorporeal driveline after 1 year of support may early identify driveline damage. 237 Reverse Remodeling (RR) Following Rotary Blood Pump Implantation: Is There a Difference between Axial (AFP) and Centrifugal Flow Pumps (CFP)? K.L. Eleuteri, B. Soleimani, C. Brehm, E. Stephenson, W. Pae, A. El-Banayosy. Penn State Milton S. Hershey Medical Center, Hershey, PA. Purpose: Little is known about the effects of rotary flow pumps on RR and if whether there are any differences between AFP versus CFP. To study this, we performed a retrospective review of 97 patients implanted with rotary blood pumps between Jun 2006 and November 2011. Methods and Materials: Blinded LVEDD and LVSD readings were measured before and after implant, and at 3 and 6 months. LVAD speed was optimized in all patients by assuring complete closure of the aortic valve with the ventricular septum in the midline. BNP measurements were also performed at the same intervals. Results: 82 patients were implanted with an AFP, Thoratec Heartmate II®(HMII), and 15 with a CFP, HeartWare LVAS® (HW); 79 were male
Conclusions: RR has been demonstrated in both types of pumps. The extent of RR was more significant with the Heartmate II as compared to the HeartWare device. Inflow cannula diameter and gap size may contribute to RR differences. This data may be useful in identifying potential Bridge to Recovery (BTR) patients. Additional data and further evaluation is required to confirm these results. 238 Driveline Staging System: Help in Managing Acute and Chronic Driveline Infections K.L. Eleuteri, A. El-Banayosy, W. Suzanne. Mechanical Circulatory Support, Heart and Vascular Institute, Penn State Milton S. Hershey Medical Center, Hershey, PA. Purpose: Despite advances in LVAD technology with smaller pumps and drivelines, infections continue to be a challenge. We developed a Driveline Grading System algorithm to target and initiate appropriate treatments based on severity and type of infection. Methods and Materials: Between January 2006 and November 1, 2011, we implanted 97 patients (79 men, 18 women with a mean age of 59 years ⫾ 10) with continuous flow left ventricular assist devices; 82 Heartmate II and 15 HeartWare LVAS. We developed a Driveline Grading System based on severity of infection (clinical observation, amount of drainage, and positive wound cultures). We also initiated a new LVAD Driveline Management Kit which included all required supplies, including 2 forms of driveline securement to alleviate driveline exit site trauma and provide early driveline incorporation. Staff and family education included the use of a mannequin for supervised LVAD driveline dressing changes. Results: The mean duration of LVAD support was 3359 days, ⫾ 340 (median 239.5 days). Total patient years on mechanical support were 92.5. 32 patients were bridge to transplantation (BTT), 21 patients were bridge to candidacy (BTC), and 46 patients were destination therapy (DT). Prior to July, 2009, 12 out of 33 patients had a documented driveline infection (36%). After July 2009, we implemented our Driveline Grading System and began using our new kits on a total of 66 patients through November 2011. Our driveline infection rate improved to16%. This illustrated a significant decrease in driveline infection rates, p⫽ 0.04. Conclusions: Although LVAD complications continue to be an hindrance with MCS patients, meticulous care and management of the LVAD driveline has helped to lower infection rates and prevent further mortality and morbidity. A Driveline Infection Grading System can be used to guide the management of driveline infections and to assist with the reduction in overall LVAD driveline infections.