- Email: [email protected]
284: Renal Dysfunction Adversely Affects Outcome after Continuous Flow Left Ventricular Assist Device Implantation
S162
Abstracts
The Journal of Heart and Lung Transplantation February 2008
tion fraction (EF) and LV end-diastolic circumferential wall stress (EDWS) were measured at baseline and at 2 and 4 hours after instituting CAFA or IABP. LV tissue obtained at end of 4 hours of therapy was used to measure mRNA expression of SERCA-2a, and the stretch response genes p21ras, p38MAPK and BNP. Results: IABP had no significant effects on LVEDP, ESV, and EF. In contrast, institution of CAFA for 4 hours significantly decreased LVEDP and ESV and increased EF. CAFA resulted in a greater reduction of EDWS than IABP. In addition, CAFA was accompanied by better normalization of expression of SERCA-2a, p21ras, p38MAPK and BNP compared to IABP. Conclusions: The results indicate that CAFA is superior to IABP in achieving acute global LV unloading and improved LV gene expression in chronic HF not complicated by ongoing myocardial ischemia and/or cardiogenic shock. IABP
LVEDP (mmHg) ESV (ml) EF (%) EDWS (gm/cm2)
CAFA
Baseline
2 Hours
4 Hours
Baseline
2 Hours
4 Hours
15 ⫾ 1 38 ⫾ 1 36 ⫾ 1 83 ⫾ 6
14 ⫾ 1 37 ⫾ 1 37 ⫾ 1 73 ⫾ 58*
14 ⫾ 1 38 ⫾ 1 36 ⫾ 1 69 ⫾ 4*
17 ⫾ 1 38 ⫾ 1 36 ⫾ 1 85 ⫾ 4
13 ⫾ 1* 31 ⫾ 1* 43 ⫾ 1* 61 ⫾ 3*
13 ⫾ 1* 27 ⫾ 1* 46 ⫾ 2* 53 ⫾ 2*
* ⫽ p⬍0.05 vs. Baseline
282 The DuraHeart™ Left Ventricular Assist System Requires Less Intensive Antocoagulation A. El-Banayosy,1 R. Koerfer,1 C. Nojiri,2 1Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Bad Oeynhausen, Germany; 2Terumo Heart Inc., Ann Arbor, MI Purpose: There has been concern that rotary blood pumps (RBP) provoke thrombosis unless aggressive anticoagulation (AC) therapy with multiple antiplatelet agents (AP) controlled by a thrombelastogram in addition to coumadin and aspirin is applied. In some RBPs thrombolysis using recombinant plasminogen activator was required to resolve pump thrombosis. This aggressive therapy sometimes resulted in fatal hemorrhagic stroke (HS). Risk of stroke exponentially increases with age after 40 – 45 years. HS has a significantly higher mortality rate within 30 days for patients (pts) older than 45 years than ischemic stroke (IS). We analyzed the rate of neurological dysfunction for the DuraHeart LVAS (DH) in association with AC/AP therapy. Methods and Materials: 26 pts (4 females) with end-stage heart failure (NYHA class IV, 10 ischemic), eligible for cardiac tx, received a DH. Median age was 58 (29-72) years (ⱖ 60 years: 46%, ⱖ65 years: 23%). Results: Average support duration was 192⫾170 (17-635) days (cumulative duration 13.7 years). There were 7 deaths; the majority of deaths (85%) occurred in the first 11 pts.(older than 60 years) and were due to massive intracerebral bleeding and subdural hematoma, likely associated with excessive AC therapy. It was then ensured that investigators followed the sponsor’s guideline of AC/AP. Since then, no HS or IS was reported in the last 15 pts.The linearized rate of neurological events was 0.12/patient-month for the earlier patient group, and 0.01/patient-month for the last 15 pts, showing a significantly low neurological event rate (p⫽0.001) after implementing less intensive AC. Stroke free Kaplan-Meier survival estimate for the last 15 pts at 1 year was 89%. There was 1 late death due to multi-organ failure in this group. Despite less intensive AC/AP therapy, no pump thrombosis, or device-related thromboembolic events occurred. Conclusions: The data suggest that the AC/AP regimen should be as low as possible, especially in older patients. The DH provided stroke and pump thrombosis free operation despite less intensive AC therapy.
283 Use of the Tandem Heart Percutaneous Ventricular Assist System in High-Risk Cardiac Surgery I. Gregoric,1 B. Bruckner,2 L. Jacob,1 S. LaFrancesca,1 B. Kar,1 P. Loyalka,1 M. Loebe,2 O.H. Frazier,1 1Cardiopulmonary Transplantation, Texas Heart Institute, Houston, TX; 2DeBakey Heart Center, The Methodist Hospital, Houston, TX Purpose: The TandemHeart Percutaneous Ventricular Assist (PTVA) System has been used successfully as a rescue device in patients with terminal cardiogenic shock. Methods and Materials: In 32 patients with refractory cardiogenic shock, the PTVA was used as a bridge to additional cardiac surgery: 5 patients underwent cardiac transplantation; 14 patients underwent left ventricular assist device (LVAD) implantation; and 13 patients underwent other cardiac surgery. Results: During the mean follow-up period of 8.1 months, there were 8 deaths, for a mortality of 25%. None of the deaths were related to the TandemHeart device. Of the 14 LVAD patients, 3 expired during support, 1 was bridged to transplant and the rest are still undergoing long-term support. Five of the 13 cardiac surgery patients expired in the immediate post-operative period, while the 5 patients bridged to transplant are currently alive. Complications related to the TandemHeart included minor bleeding around the femoral artery cannula requiring blood transfusion (n⫽3), retroperitoneal bleed (n⫽1), residual atrial septal defect that required percutaneous closure (n⫽1), and lower-extremity ischemia (n⫽1). Out of the 14 patients with long term LVADs, 6 patients had ASDs closed prophylactically thru sternotomy. Of the remaining 8 patients (non-sternotomy patients), only 1 ASD had clinically significant hypoxemia and therefore the AS was closed by percutaneous means. Conclusions: In patients with refractory cardiogenic shock, the TandemHeart proved quite promising as a bridge to transplantation, LVAD use, or further cardiac surgery. Additional studies are needed to better delineate which patients will benefit most from this technology. 284 Renal Dysfunction Adversely Affects Outcome after Continuous Flow Left Ventricular Assist Device Implantation S.E. Sandner,1 D. Zimpfer,1 P. Zrunek,1 B. Steinlechner,2 A. Rajek,2 H. Schima,1 E. Wolner,1 G.M. Wieselthaler,1 1 Cardiothoracic Surgery, Medical University of Vienna, Vienna, Austria; 2Cardiothoracic Anesthesia, Medical University of Vienna, Vienna, Austria Purpose: Renal dysfunction is a risk factor for morbidity and mortality with the use of left ventricular assist devices (LVAD). We determined the effect of pre-LVAD renal function on outcome after continuous flow LVAD implantation. Methods and Materials: From 11/98 to 07/07 87 patients with end-stage heart failure underwent implantation of continuous flow LVADs as bridge to transplantation. Renal function was assessed using the Modification of Diet in Renal Disease (MDRD)-derived glomerular filtration rates (GFR, mL/min/1.73 m2). Patients were categorized into 2 groups: normal renal function (Group 1, GFR ⬎60, n ⫽ 47, 54%), and renal dysfunction (Group 2, GFR ⬍60, n ⫽ 40, 46%). Results: Sixty eight % (Group 1) and 40% (Group 2) underwent heart transplantation or had ongoing LVAD support at 6 months (P ⫽ 0.009). Actuarial survival at 1 and 6 months was 92% and 75% (Group 1) and 93% and 48% (Group 2) (P ⫽ 0.03). Bridge-to-transplant rate was 64% (Group 1) and 35% (Group 2) (P ⫽ 0.007). Mean duration of LVAD support was 150 ⫾ 106 days (Group 1) and 129 ⫾ 111 days (Group 2) (P ⫽ 0.36). Incidence of acute renal failure was 34% (Group 1) and 40% (Group 2) (P ⫽ 0.56). Incidence of death from
The Journal of Heart and Lung Transplantation Volume 27, Number 2S
Abstracts
multi-organ failure and sepsis was 0% and 54% (Group 1) and 45% (P ⫽ 0.005) and 25% (P ⫽ 0.09) (Group 2). Overall GFR (Group 2) increased from 41 ⫾ 11 to 72 ⫾ 20 (P ⬍0.001) on LVAD support. Actuarial survival at 6 months was 63% in patients whose GFR increased to ⬎60 and 35% in patients whose GFR remained ⬍60 (P ⫽ 0.01). Conclusions: Renal dysfunction adversely affects outcome after continuous flow LVAD implantation. 285 Similar Transplant Survival for Non-Recoverable Acute and Chronic Heart Failure Patients Bridged with VADS D.J. Goldstein,1 M.B. Anderson,2 A.J. Crumbley III,3 J.A. Elefteriades,4 M.M. Madani,5 1Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY; 2Surgery, Robert Wood Johnson Medical Center, New Brunswick, NJ; 3 Surgery, Medical University of South Carolina, Charleston, SC; 4 Surgery, Yale University Medical Center, New Haven, CT; 5 Surgery, University of California at San Diego Medical Center, San Diego, CA Purpose: Regardless of etiology, patients in profound cardiogenic shock often require circulatory support. For acute heart failure (AHF) patients, recovery of ventricular function and device explantation is the desired outcome. However, when end-organ recovery occurs without concomitant cardiac recovery, cardiac transplantation remains an option. For acutely decompensated chronic heart failure (CHF) patients, recovery is unlikely and transplantation is the preferred goal. This study compares the bridge-to-transplant (BTT) and early post-transplant survival of AHF patients with those of acutely decompensated CHF patients. Methods and Materials: Data were obtained from the Abiomed voluntary registry. All patients who were implanted with the AB5000 VAD system for bridge-to-recovery (BTR) but were later listed for transplant constitute the AHF group (n⫽29, 19 centers). These included patients with acute MI (76%) or myocarditis (24%). For comparison, results were analyzed for a CHF group (n⫽29, 14 centers) with acute cardiac decompensation who also received the AB5000. Results: Patient group (N)
AHF (29)
CHF (29)
p-value
Required BiVAD Support (#, % pts) Recovered (#, % pts surviving 30 days post-wean) Transplanted (#, % of non-recovered pts) Survived 30 days post-transplant (#, % of transplanted pts) Total duration of VAD support (days, mean ⫾ SD)
9 (31%) 4 (14%)
18 (62%) 1 (3%)
0.013 NS
19 (76%)
19 (68%)
NS
16 (84%)
17 (90%)
NS
38 ⫾ 29
27 ⫾ 22
NS
Conclusions: Use of the AB5000 in patients with acutely decompensated CHF provides BTT survival and post-transplantation survival similar to that experienced by AHF patients who are transplanted subsequent to the BTR phase. This suggests that the benefit of the VAD in stabilizing cardiogenic shock patients is an important determinant of transplant success for either disease etiology. Because of a moderate chance of recovery after listing for transplantation, efforts to induce and assess recovery should continue until transplantation. 286 The Effect of Centrifugal, Axial, and Pulsatile Left Ventricular Assist Device Support on End-Organ Function in Heart Failure Patients
S163
F. Kamdar,1 A. Boyle,1 M. Colvin-Adams,1 M. Pritzker,1 E. Missov,1 K. Liao,1 L. Joyce,1 R. John,1 1University of Minnesota, Minneapolis Purpose: Evolving LVAD design has led to the development of newer continuous flow devices. Questions existed about the safety of nonpulsatile flow, but previous studies have shown that end organ function is well maintained with either pulsatile or axial flow devices. It remains to be seen if newer centrifugal LVADs have similar effects. Methods and Materials: We reviewed all patients who underwent LVAD implantation as BTT at our institution between January 2004 and May 2007. Centrifugal, axial, and pulsatile devices were represented by VentrAssist (VA), HeartMate (HM) II, and HeartMate (HM) XVE respectively. Results: 8 VA, 30 HM II, and 18 HM XVE were implanted during this period. Overall demographics were comparable amongst the three patient groups. No significant differences existed between groups with respect to renal function or hepatic function at baseline. At the 1 and 3 month follow-up after LVAD support, renal and hepatic function either improved or remained within normal limits in all patients. Conclusions: Adequate circulatory support is provided by centrifugal, axial, and pulsatile LVADs to maintain appropriate end-organ function. The advantages of newer continuous flow devices are that the pumps can be miniaturized with improved reliability. However, long term studies to assess end organ function with continuous flow devices are needed, as this may have important implications for use as destination therapy. Table 1: Laboratory values by LVAD type
Creatinine [mg/dl] BUN [mg/ dl] TBili [mg/ dl] ALT [U/L] AST [U/L]
Centrifugal (nⴝ8)
Axial (nⴝ30)
Pulsatile (nⴝ18)
Baseline
3 Months
Baseline
3 Months
Baseline
3 Months
1.21⫾0.52
0.99⫾0.29
1.5⫾0.57
1.2⫾0.53
1.17⫾0.23
1.1⫾0.3
21.4⫾12.4
17.4⫾7.2
34.9⫾18.8
22.6⫾13.1
25.5⫾11.6
20.3⫾9.5
1.58⫾1.8
0.44⫾0.23
1.32⫾0.86
0.78⫾0.5
1.29⫾1.07
0.68⫾0.4
36.0⫾14.0 33.3⫾11.1
37.1⫾16.0 39.8⫾8.69
69.1⫾104 72.2 ⫾122
36.2⫾19.3 53.5⫾30
29.8⫾7.78 36.2⫾23.3
28.6⫾22.2 35.9⫾17.1
287 Routine Left Ventricular Device Exchange? L. Lozonschi,1 N.M. Edwards,1 M.R. Johnson,2 S. Osaki,1 T. Kohmoto,1 1Department of Cardiothoracic Surgery, University of Wisconsin School of Medicine, Madison, WI; 2Division of Heart Failure and Transplant Cardiology, University of Wisconsin School of Medicine, Madison, WI Purpose: Patient survival on LVAD support often exceeds the life of one device. Methods and Materials: Between August 2003 and August 2007, 54 heart failure patients received mechanical assist devices at our institution. Outcomes of patients after first LVAD implant and of those who underwent LVAD exchange were reviewed. Results: Actuarial survival in the entire LVAD group (n⫽54) was 85%, 79% and 74% at 1, 2 and 3 years respectively (Figure). Out of 7 (11.4%) patients that required LVAD exchange, 5 were performed at our institution and one patient required more than two devices. The median support time for the 1st device implanted was 108 days for the entire group, 433 days in LVAD exchange group and 297 days for the 2nd device. There was no in-hospital 30-day mortality for either 1st time LVAD implant group or LVAD exchange group. Indication for LVAD exchange was inflow valve regurgitation in all but two patients who demonstrated advanced bearing wear. Hospital stay was 23 ⫾ 36 (median of 7) days in the LVAD exchange group and 22 ⫾16 (median of 13) days in the entire group at 1st LVAD implant procedure. There was no right heart failure in
Abstracts
The Journal of Heart and Lung Transplantation February 2008
tion fraction (EF) and LV end-diastolic circumferential wall stress (EDWS) were measured at baseline and at 2 and 4 hours after instituting CAFA or IABP. LV tissue obtained at end of 4 hours of therapy was used to measure mRNA expression of SERCA-2a, and the stretch response genes p21ras, p38MAPK and BNP. Results: IABP had no significant effects on LVEDP, ESV, and EF. In contrast, institution of CAFA for 4 hours significantly decreased LVEDP and ESV and increased EF. CAFA resulted in a greater reduction of EDWS than IABP. In addition, CAFA was accompanied by better normalization of expression of SERCA-2a, p21ras, p38MAPK and BNP compared to IABP. Conclusions: The results indicate that CAFA is superior to IABP in achieving acute global LV unloading and improved LV gene expression in chronic HF not complicated by ongoing myocardial ischemia and/or cardiogenic shock. IABP
LVEDP (mmHg) ESV (ml) EF (%) EDWS (gm/cm2)
CAFA
Baseline
2 Hours
4 Hours
Baseline
2 Hours
4 Hours
15 ⫾ 1 38 ⫾ 1 36 ⫾ 1 83 ⫾ 6
14 ⫾ 1 37 ⫾ 1 37 ⫾ 1 73 ⫾ 58*
14 ⫾ 1 38 ⫾ 1 36 ⫾ 1 69 ⫾ 4*
17 ⫾ 1 38 ⫾ 1 36 ⫾ 1 85 ⫾ 4
13 ⫾ 1* 31 ⫾ 1* 43 ⫾ 1* 61 ⫾ 3*
13 ⫾ 1* 27 ⫾ 1* 46 ⫾ 2* 53 ⫾ 2*
* ⫽ p⬍0.05 vs. Baseline
282 The DuraHeart™ Left Ventricular Assist System Requires Less Intensive Antocoagulation A. El-Banayosy,1 R. Koerfer,1 C. Nojiri,2 1Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Bad Oeynhausen, Germany; 2Terumo Heart Inc., Ann Arbor, MI Purpose: There has been concern that rotary blood pumps (RBP) provoke thrombosis unless aggressive anticoagulation (AC) therapy with multiple antiplatelet agents (AP) controlled by a thrombelastogram in addition to coumadin and aspirin is applied. In some RBPs thrombolysis using recombinant plasminogen activator was required to resolve pump thrombosis. This aggressive therapy sometimes resulted in fatal hemorrhagic stroke (HS). Risk of stroke exponentially increases with age after 40 – 45 years. HS has a significantly higher mortality rate within 30 days for patients (pts) older than 45 years than ischemic stroke (IS). We analyzed the rate of neurological dysfunction for the DuraHeart LVAS (DH) in association with AC/AP therapy. Methods and Materials: 26 pts (4 females) with end-stage heart failure (NYHA class IV, 10 ischemic), eligible for cardiac tx, received a DH. Median age was 58 (29-72) years (ⱖ 60 years: 46%, ⱖ65 years: 23%). Results: Average support duration was 192⫾170 (17-635) days (cumulative duration 13.7 years). There were 7 deaths; the majority of deaths (85%) occurred in the first 11 pts.(older than 60 years) and were due to massive intracerebral bleeding and subdural hematoma, likely associated with excessive AC therapy. It was then ensured that investigators followed the sponsor’s guideline of AC/AP. Since then, no HS or IS was reported in the last 15 pts.The linearized rate of neurological events was 0.12/patient-month for the earlier patient group, and 0.01/patient-month for the last 15 pts, showing a significantly low neurological event rate (p⫽0.001) after implementing less intensive AC. Stroke free Kaplan-Meier survival estimate for the last 15 pts at 1 year was 89%. There was 1 late death due to multi-organ failure in this group. Despite less intensive AC/AP therapy, no pump thrombosis, or device-related thromboembolic events occurred. Conclusions: The data suggest that the AC/AP regimen should be as low as possible, especially in older patients. The DH provided stroke and pump thrombosis free operation despite less intensive AC therapy.
283 Use of the Tandem Heart Percutaneous Ventricular Assist System in High-Risk Cardiac Surgery I. Gregoric,1 B. Bruckner,2 L. Jacob,1 S. LaFrancesca,1 B. Kar,1 P. Loyalka,1 M. Loebe,2 O.H. Frazier,1 1Cardiopulmonary Transplantation, Texas Heart Institute, Houston, TX; 2DeBakey Heart Center, The Methodist Hospital, Houston, TX Purpose: The TandemHeart Percutaneous Ventricular Assist (PTVA) System has been used successfully as a rescue device in patients with terminal cardiogenic shock. Methods and Materials: In 32 patients with refractory cardiogenic shock, the PTVA was used as a bridge to additional cardiac surgery: 5 patients underwent cardiac transplantation; 14 patients underwent left ventricular assist device (LVAD) implantation; and 13 patients underwent other cardiac surgery. Results: During the mean follow-up period of 8.1 months, there were 8 deaths, for a mortality of 25%. None of the deaths were related to the TandemHeart device. Of the 14 LVAD patients, 3 expired during support, 1 was bridged to transplant and the rest are still undergoing long-term support. Five of the 13 cardiac surgery patients expired in the immediate post-operative period, while the 5 patients bridged to transplant are currently alive. Complications related to the TandemHeart included minor bleeding around the femoral artery cannula requiring blood transfusion (n⫽3), retroperitoneal bleed (n⫽1), residual atrial septal defect that required percutaneous closure (n⫽1), and lower-extremity ischemia (n⫽1). Out of the 14 patients with long term LVADs, 6 patients had ASDs closed prophylactically thru sternotomy. Of the remaining 8 patients (non-sternotomy patients), only 1 ASD had clinically significant hypoxemia and therefore the AS was closed by percutaneous means. Conclusions: In patients with refractory cardiogenic shock, the TandemHeart proved quite promising as a bridge to transplantation, LVAD use, or further cardiac surgery. Additional studies are needed to better delineate which patients will benefit most from this technology. 284 Renal Dysfunction Adversely Affects Outcome after Continuous Flow Left Ventricular Assist Device Implantation S.E. Sandner,1 D. Zimpfer,1 P. Zrunek,1 B. Steinlechner,2 A. Rajek,2 H. Schima,1 E. Wolner,1 G.M. Wieselthaler,1 1 Cardiothoracic Surgery, Medical University of Vienna, Vienna, Austria; 2Cardiothoracic Anesthesia, Medical University of Vienna, Vienna, Austria Purpose: Renal dysfunction is a risk factor for morbidity and mortality with the use of left ventricular assist devices (LVAD). We determined the effect of pre-LVAD renal function on outcome after continuous flow LVAD implantation. Methods and Materials: From 11/98 to 07/07 87 patients with end-stage heart failure underwent implantation of continuous flow LVADs as bridge to transplantation. Renal function was assessed using the Modification of Diet in Renal Disease (MDRD)-derived glomerular filtration rates (GFR, mL/min/1.73 m2). Patients were categorized into 2 groups: normal renal function (Group 1, GFR ⬎60, n ⫽ 47, 54%), and renal dysfunction (Group 2, GFR ⬍60, n ⫽ 40, 46%). Results: Sixty eight % (Group 1) and 40% (Group 2) underwent heart transplantation or had ongoing LVAD support at 6 months (P ⫽ 0.009). Actuarial survival at 1 and 6 months was 92% and 75% (Group 1) and 93% and 48% (Group 2) (P ⫽ 0.03). Bridge-to-transplant rate was 64% (Group 1) and 35% (Group 2) (P ⫽ 0.007). Mean duration of LVAD support was 150 ⫾ 106 days (Group 1) and 129 ⫾ 111 days (Group 2) (P ⫽ 0.36). Incidence of acute renal failure was 34% (Group 1) and 40% (Group 2) (P ⫽ 0.56). Incidence of death from
The Journal of Heart and Lung Transplantation Volume 27, Number 2S
Abstracts
multi-organ failure and sepsis was 0% and 54% (Group 1) and 45% (P ⫽ 0.005) and 25% (P ⫽ 0.09) (Group 2). Overall GFR (Group 2) increased from 41 ⫾ 11 to 72 ⫾ 20 (P ⬍0.001) on LVAD support. Actuarial survival at 6 months was 63% in patients whose GFR increased to ⬎60 and 35% in patients whose GFR remained ⬍60 (P ⫽ 0.01). Conclusions: Renal dysfunction adversely affects outcome after continuous flow LVAD implantation. 285 Similar Transplant Survival for Non-Recoverable Acute and Chronic Heart Failure Patients Bridged with VADS D.J. Goldstein,1 M.B. Anderson,2 A.J. Crumbley III,3 J.A. Elefteriades,4 M.M. Madani,5 1Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY; 2Surgery, Robert Wood Johnson Medical Center, New Brunswick, NJ; 3 Surgery, Medical University of South Carolina, Charleston, SC; 4 Surgery, Yale University Medical Center, New Haven, CT; 5 Surgery, University of California at San Diego Medical Center, San Diego, CA Purpose: Regardless of etiology, patients in profound cardiogenic shock often require circulatory support. For acute heart failure (AHF) patients, recovery of ventricular function and device explantation is the desired outcome. However, when end-organ recovery occurs without concomitant cardiac recovery, cardiac transplantation remains an option. For acutely decompensated chronic heart failure (CHF) patients, recovery is unlikely and transplantation is the preferred goal. This study compares the bridge-to-transplant (BTT) and early post-transplant survival of AHF patients with those of acutely decompensated CHF patients. Methods and Materials: Data were obtained from the Abiomed voluntary registry. All patients who were implanted with the AB5000 VAD system for bridge-to-recovery (BTR) but were later listed for transplant constitute the AHF group (n⫽29, 19 centers). These included patients with acute MI (76%) or myocarditis (24%). For comparison, results were analyzed for a CHF group (n⫽29, 14 centers) with acute cardiac decompensation who also received the AB5000. Results: Patient group (N)
AHF (29)
CHF (29)
p-value
Required BiVAD Support (#, % pts) Recovered (#, % pts surviving 30 days post-wean) Transplanted (#, % of non-recovered pts) Survived 30 days post-transplant (#, % of transplanted pts) Total duration of VAD support (days, mean ⫾ SD)
9 (31%) 4 (14%)
18 (62%) 1 (3%)
0.013 NS
19 (76%)
19 (68%)
NS
16 (84%)
17 (90%)
NS
38 ⫾ 29
27 ⫾ 22
NS
Conclusions: Use of the AB5000 in patients with acutely decompensated CHF provides BTT survival and post-transplantation survival similar to that experienced by AHF patients who are transplanted subsequent to the BTR phase. This suggests that the benefit of the VAD in stabilizing cardiogenic shock patients is an important determinant of transplant success for either disease etiology. Because of a moderate chance of recovery after listing for transplantation, efforts to induce and assess recovery should continue until transplantation. 286 The Effect of Centrifugal, Axial, and Pulsatile Left Ventricular Assist Device Support on End-Organ Function in Heart Failure Patients
S163
F. Kamdar,1 A. Boyle,1 M. Colvin-Adams,1 M. Pritzker,1 E. Missov,1 K. Liao,1 L. Joyce,1 R. John,1 1University of Minnesota, Minneapolis Purpose: Evolving LVAD design has led to the development of newer continuous flow devices. Questions existed about the safety of nonpulsatile flow, but previous studies have shown that end organ function is well maintained with either pulsatile or axial flow devices. It remains to be seen if newer centrifugal LVADs have similar effects. Methods and Materials: We reviewed all patients who underwent LVAD implantation as BTT at our institution between January 2004 and May 2007. Centrifugal, axial, and pulsatile devices were represented by VentrAssist (VA), HeartMate (HM) II, and HeartMate (HM) XVE respectively. Results: 8 VA, 30 HM II, and 18 HM XVE were implanted during this period. Overall demographics were comparable amongst the three patient groups. No significant differences existed between groups with respect to renal function or hepatic function at baseline. At the 1 and 3 month follow-up after LVAD support, renal and hepatic function either improved or remained within normal limits in all patients. Conclusions: Adequate circulatory support is provided by centrifugal, axial, and pulsatile LVADs to maintain appropriate end-organ function. The advantages of newer continuous flow devices are that the pumps can be miniaturized with improved reliability. However, long term studies to assess end organ function with continuous flow devices are needed, as this may have important implications for use as destination therapy. Table 1: Laboratory values by LVAD type
Creatinine [mg/dl] BUN [mg/ dl] TBili [mg/ dl] ALT [U/L] AST [U/L]
Centrifugal (nⴝ8)
Axial (nⴝ30)
Pulsatile (nⴝ18)
Baseline
3 Months
Baseline
3 Months
Baseline
3 Months
1.21⫾0.52
0.99⫾0.29
1.5⫾0.57
1.2⫾0.53
1.17⫾0.23
1.1⫾0.3
21.4⫾12.4
17.4⫾7.2
34.9⫾18.8
22.6⫾13.1
25.5⫾11.6
20.3⫾9.5
1.58⫾1.8
0.44⫾0.23
1.32⫾0.86
0.78⫾0.5
1.29⫾1.07
0.68⫾0.4
36.0⫾14.0 33.3⫾11.1
37.1⫾16.0 39.8⫾8.69
69.1⫾104 72.2 ⫾122
36.2⫾19.3 53.5⫾30
29.8⫾7.78 36.2⫾23.3
28.6⫾22.2 35.9⫾17.1
287 Routine Left Ventricular Device Exchange? L. Lozonschi,1 N.M. Edwards,1 M.R. Johnson,2 S. Osaki,1 T. Kohmoto,1 1Department of Cardiothoracic Surgery, University of Wisconsin School of Medicine, Madison, WI; 2Division of Heart Failure and Transplant Cardiology, University of Wisconsin School of Medicine, Madison, WI Purpose: Patient survival on LVAD support often exceeds the life of one device. Methods and Materials: Between August 2003 and August 2007, 54 heart failure patients received mechanical assist devices at our institution. Outcomes of patients after first LVAD implant and of those who underwent LVAD exchange were reviewed. Results: Actuarial survival in the entire LVAD group (n⫽54) was 85%, 79% and 74% at 1, 2 and 3 years respectively (Figure). Out of 7 (11.4%) patients that required LVAD exchange, 5 were performed at our institution and one patient required more than two devices. The median support time for the 1st device implanted was 108 days for the entire group, 433 days in LVAD exchange group and 297 days for the 2nd device. There was no in-hospital 30-day mortality for either 1st time LVAD implant group or LVAD exchange group. Indication for LVAD exchange was inflow valve regurgitation in all but two patients who demonstrated advanced bearing wear. Hospital stay was 23 ⫾ 36 (median of 7) days in the LVAD exchange group and 22 ⫾16 (median of 13) days in the entire group at 1st LVAD implant procedure. There was no right heart failure in