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566: Improved Outcomes after Ventricular Assist Device Implantation in Patients Requiring Intra-Aortic Balloon Pump
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The Journal of Heart and Lung Transplantation, Vol 29, No 2S, February 2010
off-pump procedure. The inflow cannula draws blood from the LA and pumps blood via an outflow graft to the subclavian artery. We compared the adverse events associated with Synergy to a similar HeartMate II patient population. Results: 27 patients with baseline MAP 76 mmHg, PCWP 27 mmHg and CO 2.6 L/min were implanted with a Synergy device. Duration of support averaged 106 (6-281) days. Survival to discharge or transplantation was 93% (25/27). Hemodynamics, demographics and overall outcomes are similar to those reported for HeartMate II. The rates of adverse events (events/patient year) are summarized below:[table1]
HeartMate IIⴱ
CircuLite
Bleeding (re-op) Bleeding (transfusion) Ventricular arrhythmias Driveline/pocket infection Local infection (non-device) Sepsis Renal failure Stroke Embolism during pump exchange Spinal cord infarct TIA Other neurologic ⴱ
hemodynamical stabilization by IABP might contribute to improve postVAD outcomes.[figure1]
0-30 Days
⬎30 Days
0-30 (Days
⬎30 (Days)
2.62 1.05 1.57 0.52 0.52 0.52 0.52 0.52 0 0 0 0
0 0.42 0.21 0.21 0.84 0.21 0.42 0 0.21 0 0 0.21
4.41 8.33 2.55 0 3.63 1.77 1.47 0.89 0 0 0.2 0.29
0.06 0.85 0.45 0.45 0.64 0.39 0.08 0.08 0 0.02 0.08 0.14
Miller et al, NEJM 2007
Conclusions: Partial circulatory support with the Synergy device, which is less invasive and intended for a less sick population, appears to result in less adverse events as compared to HeartMate II. This device has the potential to expand the use of circulatory support to a large group of patients with severe medically refractory CHF. 566 Improved Outcomes after Ventricular Assist Device Implantation in Patients Requiring Intra-Aortic Balloon Pump S. Osaki,1 N.M. Edwards,1 M.R. Johnson,2 M.A. Murray,1 A.K. Proebstle,1 L. Lozonschi,1 T. Kohmoto.1 1University of Wisconsin School of Medicine and Public Health, Madison, WI; 2University of Wisconsin School of Medicine and Public Health, Madison, WI. Purpose: Recently a multicenter registry for ventricular assist device (VAD) support reported that cardiogenic shock requiring temporary circulatory support such as an intra-aortic balloon pump (IABP) was a significant risk factor for death after VAD therapy. To determine if the need for pre-operative IABP is a risk factor for post-VAD survival, we evaluated the outcomes since the inception of our multidisciplinary VAD and heart transplantation program. Methods and Materials: We retrospectively studied 89 consecutive VAD recipients between Aug 2003 and Sept 2009 in our center. The cohort was divided into the IABP (with IABP before VAD, n⫽31) and the non-IABP (without IABP before VAD, n⫽58) groups. Demographics and post-VAD implant survival were assessed. Results: Patient age, diagnosis, and cardiac function were similar between the groups. However, the patients with IABP had lower mean pulmonary arterial pressure (34 vs 41 mmHg, p⬍0.01) and a higher serum aspartate aminotransferase level (657 vs 62 U/L, p⬍0.01). The rate of biventricular support was similar between the groups (3/31 [10%] vs 4/58 [7%], p⫽0.80). Post-VAD implant survival at 30-day, 1-year and 3-year was 100%, 86% and 72% in the IABP group, and 95%, 74% and 69% in the non-IABP group (p⫽0.52, Figure). Conclusions: Our data demonstrates excellent short- and mid-term survival in both groups. The data does not support the notion that preoperative IABP support is associated with worse post VAD outcomes. In fact, despite higher prevalence of cardiogenic shock criteria, the IABP supported patients did not fare worse than patients without IABP support. Pre-VAD
567 Single-Center Experience Using the Heartmate II Left Ventricular Assist Device as a Bridge to Decision M. Toma,1 G.V. Gonzalez-Stawinski,2 D. Schmuhl,1 N.G. Smedira,2 R.C. Starling,1 M.M. Mountis.1 1The Cleveland Clinic Foundation, Cleveland, OH; 2The Cleveland Clinic Foundation, Cleveland, OH. Purpose: There is scant data regarding the outcomes of patients deemed Bridge to Decision (BTD) with a HeartMate II left ventricular assist device (LVAD). We sought to review the outcomes of patients who received a HM II LVAD as BTD. Methods and Materials: All patients who received a HM II LVAD between June 2006 and July 2009 were included in this analysis and followed for a mean period of 235 days. BTD was defined using the Interagency Registry for Mechanical Assisted Circulatory Support (INTERMACS) strategy at implant (BTT – likely, BTT – moderate likelihood, BTT – unlikely). We reviewed the factors precluding listing as BTT. Clinical outcomes at 30-days and end of follow-up were determined. Results: A total of 96 patients underwent implantation of HM II LVAD during the study period. The listing strategy was BTD in 34 pts (35%), BTT in 41 pts (43%), and DT in 21 pts (22%). Of the 34 pts listed as BTD, 24 (71%) were BTT-likely, 8 (24%) were BTT-moderate, and 2 (6%) were BTT-unlikely. Factors for BTD listing were: psychosocial issues (6), substance abuse (5), pulmonary hypertension (4), morbid obesity (3), history of malignancy (2), kidney dysfunction (1) and emergent implantation (4), and other (9). The 30-day and end of follow-up survival were 91% and 79%, respectively, for BTD; 95% and 83%, respectively, for BTT; and 86% and 52% for DT, respectively. Of those alive at the end of follow-up in the BTD group, 5 were transplanted, 4 were changed to BTT, 2 were changed to DT, and 16 remain listed as BTD. Conclusions: The BTD strategy is commonly used in patients undergoing LVAD support using the HM II LVAD and is associated with favorable clinical outcomes. The 30-day and end of follow-up survival for BTT listed patients and BTD (likely, moderately, and unlikely) were similar for both groups. Further, many BTD candidates became BTT patients. Future guidelines should incorporate BTD as an accepted category for patients receiving LVAD support. 568 Liberal Use of Tricuspid Valve Annuloplasty during Left Ventricular Assist Device Implantation Does Not Increase Perioperative Risk K. Krishan, S. Pinney, V. Ramjee, D. Adams, A. Anyanwu. Mount Sinai Medical Center, New York, NY. Purpose: Although patients undergoing left ventricular assist device (LVAD) surgery often have tricuspid regurgitation (TR), tricuspid valve repair (TVr) is not generally performed during because of fear of precipitating right ventricular failure or increasing morbidity. Persisting TR post-LVAD may however have significant mid-term implications, particularly in destination or recovery patients. We reviewed our experience to determine whether liberal use of TVr is associated with adverse outcomes. Methods and Materials: Retrospective review of 43 implantable LVADs
The Journal of Heart and Lung Transplantation, Vol 29, No 2S, February 2010
off-pump procedure. The inflow cannula draws blood from the LA and pumps blood via an outflow graft to the subclavian artery. We compared the adverse events associated with Synergy to a similar HeartMate II patient population. Results: 27 patients with baseline MAP 76 mmHg, PCWP 27 mmHg and CO 2.6 L/min were implanted with a Synergy device. Duration of support averaged 106 (6-281) days. Survival to discharge or transplantation was 93% (25/27). Hemodynamics, demographics and overall outcomes are similar to those reported for HeartMate II. The rates of adverse events (events/patient year) are summarized below:[table1]
HeartMate IIⴱ
CircuLite
Bleeding (re-op) Bleeding (transfusion) Ventricular arrhythmias Driveline/pocket infection Local infection (non-device) Sepsis Renal failure Stroke Embolism during pump exchange Spinal cord infarct TIA Other neurologic ⴱ
hemodynamical stabilization by IABP might contribute to improve postVAD outcomes.[figure1]
0-30 Days
⬎30 Days
0-30 (Days
⬎30 (Days)
2.62 1.05 1.57 0.52 0.52 0.52 0.52 0.52 0 0 0 0
0 0.42 0.21 0.21 0.84 0.21 0.42 0 0.21 0 0 0.21
4.41 8.33 2.55 0 3.63 1.77 1.47 0.89 0 0 0.2 0.29
0.06 0.85 0.45 0.45 0.64 0.39 0.08 0.08 0 0.02 0.08 0.14
Miller et al, NEJM 2007
Conclusions: Partial circulatory support with the Synergy device, which is less invasive and intended for a less sick population, appears to result in less adverse events as compared to HeartMate II. This device has the potential to expand the use of circulatory support to a large group of patients with severe medically refractory CHF. 566 Improved Outcomes after Ventricular Assist Device Implantation in Patients Requiring Intra-Aortic Balloon Pump S. Osaki,1 N.M. Edwards,1 M.R. Johnson,2 M.A. Murray,1 A.K. Proebstle,1 L. Lozonschi,1 T. Kohmoto.1 1University of Wisconsin School of Medicine and Public Health, Madison, WI; 2University of Wisconsin School of Medicine and Public Health, Madison, WI. Purpose: Recently a multicenter registry for ventricular assist device (VAD) support reported that cardiogenic shock requiring temporary circulatory support such as an intra-aortic balloon pump (IABP) was a significant risk factor for death after VAD therapy. To determine if the need for pre-operative IABP is a risk factor for post-VAD survival, we evaluated the outcomes since the inception of our multidisciplinary VAD and heart transplantation program. Methods and Materials: We retrospectively studied 89 consecutive VAD recipients between Aug 2003 and Sept 2009 in our center. The cohort was divided into the IABP (with IABP before VAD, n⫽31) and the non-IABP (without IABP before VAD, n⫽58) groups. Demographics and post-VAD implant survival were assessed. Results: Patient age, diagnosis, and cardiac function were similar between the groups. However, the patients with IABP had lower mean pulmonary arterial pressure (34 vs 41 mmHg, p⬍0.01) and a higher serum aspartate aminotransferase level (657 vs 62 U/L, p⬍0.01). The rate of biventricular support was similar between the groups (3/31 [10%] vs 4/58 [7%], p⫽0.80). Post-VAD implant survival at 30-day, 1-year and 3-year was 100%, 86% and 72% in the IABP group, and 95%, 74% and 69% in the non-IABP group (p⫽0.52, Figure). Conclusions: Our data demonstrates excellent short- and mid-term survival in both groups. The data does not support the notion that preoperative IABP support is associated with worse post VAD outcomes. In fact, despite higher prevalence of cardiogenic shock criteria, the IABP supported patients did not fare worse than patients without IABP support. Pre-VAD
567 Single-Center Experience Using the Heartmate II Left Ventricular Assist Device as a Bridge to Decision M. Toma,1 G.V. Gonzalez-Stawinski,2 D. Schmuhl,1 N.G. Smedira,2 R.C. Starling,1 M.M. Mountis.1 1The Cleveland Clinic Foundation, Cleveland, OH; 2The Cleveland Clinic Foundation, Cleveland, OH. Purpose: There is scant data regarding the outcomes of patients deemed Bridge to Decision (BTD) with a HeartMate II left ventricular assist device (LVAD). We sought to review the outcomes of patients who received a HM II LVAD as BTD. Methods and Materials: All patients who received a HM II LVAD between June 2006 and July 2009 were included in this analysis and followed for a mean period of 235 days. BTD was defined using the Interagency Registry for Mechanical Assisted Circulatory Support (INTERMACS) strategy at implant (BTT – likely, BTT – moderate likelihood, BTT – unlikely). We reviewed the factors precluding listing as BTT. Clinical outcomes at 30-days and end of follow-up were determined. Results: A total of 96 patients underwent implantation of HM II LVAD during the study period. The listing strategy was BTD in 34 pts (35%), BTT in 41 pts (43%), and DT in 21 pts (22%). Of the 34 pts listed as BTD, 24 (71%) were BTT-likely, 8 (24%) were BTT-moderate, and 2 (6%) were BTT-unlikely. Factors for BTD listing were: psychosocial issues (6), substance abuse (5), pulmonary hypertension (4), morbid obesity (3), history of malignancy (2), kidney dysfunction (1) and emergent implantation (4), and other (9). The 30-day and end of follow-up survival were 91% and 79%, respectively, for BTD; 95% and 83%, respectively, for BTT; and 86% and 52% for DT, respectively. Of those alive at the end of follow-up in the BTD group, 5 were transplanted, 4 were changed to BTT, 2 were changed to DT, and 16 remain listed as BTD. Conclusions: The BTD strategy is commonly used in patients undergoing LVAD support using the HM II LVAD and is associated with favorable clinical outcomes. The 30-day and end of follow-up survival for BTT listed patients and BTD (likely, moderately, and unlikely) were similar for both groups. Further, many BTD candidates became BTT patients. Future guidelines should incorporate BTD as an accepted category for patients receiving LVAD support. 568 Liberal Use of Tricuspid Valve Annuloplasty during Left Ventricular Assist Device Implantation Does Not Increase Perioperative Risk K. Krishan, S. Pinney, V. Ramjee, D. Adams, A. Anyanwu. Mount Sinai Medical Center, New York, NY. Purpose: Although patients undergoing left ventricular assist device (LVAD) surgery often have tricuspid regurgitation (TR), tricuspid valve repair (TVr) is not generally performed during because of fear of precipitating right ventricular failure or increasing morbidity. Persisting TR post-LVAD may however have significant mid-term implications, particularly in destination or recovery patients. We reviewed our experience to determine whether liberal use of TVr is associated with adverse outcomes. Methods and Materials: Retrospective review of 43 implantable LVADs