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574: Sildenafil or Bosentan in Patients Considered Inelegible for Heart Transplantation Because of Severe Pulmonary Hypertension
The Journal of Heart and Lung Transplantation Volume 28, Number 2S
Methods and Materials: The post-transplant outcome of 485 (82%) elective, 64 (11%) LVAD (DeBakey, Duraheart, Heartware LVAD) and 43 (7%) urgent patients (HU) undergoing cardiac transplantation between January 1998 and May 2008 was retrospectively analyzed. Survival, incidence of rejection, severe infections, CMV-disease and graft vasculopathy (CAV) were compared. All patients received immunosuppressive quadruple therapy consisting of thymoglobuline, Tac/Cyclo⫹MMF/Evl and low dose steroids. Kaplan-Meier analysis was performed to test differences between the groups. Results: Patients in the three groups were comparable with regard to primary disease. Urgent patients were younger (42⫾16yrs) than elective (52⫾13yrs) and LVAD (50⫾11yrs) patients (p⬍.001). Actuarial survival of elective (80%, 75%, 72%), LVAD (84%, 77%, 71%) and HU (81%, 78%, 71%) patients was comparable 1, 3 and 5 years post-transplant (log-rank .671). Furthermore, freedom from rejection episodes (elective: 91%, 90%, 90%, LVAD: 90%, 90%, 90%, HU: 93%, 93%, 93%; log-rank .991), severe infections (elective: 73%, 68%, 67%, LVAD: 84%, 82%, 82, HU: 73%, 73%, 70%; log-rank .118), CMV disease (elective: 91%, 90%, 90%, LVAD: 92%, 92%, 92%, HU: 86%, 86%, 86%; log-rank .415) and CAV (elective: 97%, 92%, 85%, LVAD: 96%, 89%, 83%, HU: 94%, 82%, 82%; log-rank .317) was comparable between elective, LVAD and HU patients 1, 3, and 5 years post-transplant respectively. Conclusions: Despite the increased risk of LVAD and urgent patients post-transplant outcome is excellent and compares to elective patients. The low incidence of rejections and CAV underlines the importance of induction therapy and individualized immunosuppression. 573 Normalization of Fixed Pulmonary Hypertension in Severe Heart Failure Patients with Placement of Left Ventricular Assist Device R. Zolty1, T. Vittorio1, B. Lowes2, S. Shakar2, A. Brieke2, A. Cannon2, J. Cleveland2, D. D’Alessandro3, D. Goldstein3, S. Maybaum3 1Albert Einstein College of Medicine, Bronx, NY; 2 University of Colorado Health Sciences Center, Aurora, CO; 3 Montefiore Medical Center, Bronx, NY Purpose: Fixed pulmonary hypertension in severe heart failure (HF) patients is an absolute contraindication to cardiac transplantation. The purpose of this study was to evaluate the effect of left ventricular assist device (LVAD) on pulmonary artery pressures and pulmonary vascular resistance (PVR) in patients with severe HF and fixed pulmonary hypertension non-responsive to pulmonary vasodilators and/or inotropic agents. Fixed pulmonary hypertension is defined as elevated pulmonary pressures, with a trans-pulmonary gradient ⬎15mmHg, Pulmonary Vascular Resistance (PVR) ⬎5mmHg and PA diastolic-wedge gradient⬎7mmHg, not reversible with pharmacologic agents. Methods and Materials: 12 patients with severe HF (8 non-ischemic, 4 ischemic cardiomyopathy), left ventricular ejection fraction ⬍25% and fixed pulmonary hypertension (PA systolic 66⫾7 mmHg and PVR 7.6⫾0.7 WU) underwent placement of LVAD. These patients were prospectively studied for reassessment of their hemodynamics and pulmonary artery pressures at 1 to 3 months post LVAD implantation. Results: The placement of LVAD (8 HM XVE, 4 HM II) resulted in statistical improvement of pulmonary pressures and PVR . Subsequently, all these patients were successfully transplanted with no development of RV failure after transplantation. Conclusions: Patients with severe HF and fixed pulmonary hypertension may benefit from LVAD implantation with normalization of their pulmonary pressures and may therefore subsequently be listed for orthotopic heart transplantation.
Abstracts
S265
Pulmonary Arety Pressures Improvement After Placement of LVAD Devices in 12 Patients with Fixed Pulmonary Hypertension PA PA mean Wedge Cardiac PVR systolic diastolic PA Mean Output (Wood (mmHg) (mmHg) (mmHg) Pressure (L/min) Units) (mmHg) Baseline 66⫾7 Post LVAD 36⫾2 placement P-value 0.0187* (compared to baseline)
36⫾1 14⫾4
48⫾2 23⫾2
24⫾1 13⫾2
3.1⫾0.1 7.6⫾0.7 5⫾0.6 2.2⫾0.2
0.0035*
0.0023*
0.0155*
0.028*
0.0023*
574 Sildenafil or Bosentan in Patients Considered Inelegible for Heart Transplantation Because of Severe Pulmonary Hypertension M. Farrero, F. Perez-Villa, A. Arias, A. Sionis, A. Castel, E. Roig Thorax Institut. Hospital Clinic., Barcelona, Spain Purpose: Elevated pulmonary vascular resistance (PVR) is associated to an increase in mortality in the early post-heart transplant period, mainly due to right ventricle dysfunction. This study aims to assess the effectiveness of both sildenafil and bosentan in decreasing the PVR in a group of patients initially considered ineligible for heart transplantation because of severe pulmonary hypertension. Methods and Materials: Sixteen patients with end-stage congestive heart failure and severe pulmonary hypertension were prospectively included. These were randomly assigned to receive either bosentan (125 mg bid) or sildenafil (80 mg tid). A second right heart catheterization was performed after 16 weeks of therapy. Results: No significant differences were observed in the two group’s basal characteristics. The bosentan group (n⫽7) had a basal transpulmonary gradient (TPG) of 21 ⫾6 mmHg that was reduced to 10 ⫾ 7 (p⫽0.005) during the treatment. Also the pulmonary vascular resistance decreased from 5.6 ⫾2.4 Wood units to 2.2 ⫾ 1.5 (p⫽0.003). The sildenafil group (n⫽7) showed a non significative trend towards RVP reduction (4.8 ⫾1.5 vs. 3.29 ⫾1.1; p⫽0,053) and TPG decrease (21 ⫾4 vs. 19 ⫾6; p⫽NS). TPG reduction was greater with bosentan (10.5 ⫾5 vs. 4.5 ⫾2mmHg, bosentan vs sildenafil; p⫽0.04). Treatment was stopped in 1 patient of each group due to intolerance. After treatment, 8 patients (5 bosentan, 3 sildenafil) were listed for heart transplantation and 6 of them (4 bosentan, 2 sildenafil) have already been transplanted successfully. Conclusions: Bosentan and sildenafil reduce RVP in patients considered ineligible for heart transplantation due to pulmonary hypertension, allowing them to be transplanted with good results. In our study, bosentan showed to be more effective than sildenafil in decreasing TPG and PVR. 575 Prognostic Value of Right Ventricular Dysfunction and Pulmonary Artery Hypertension Parameters for Risk Stratification of Patients with Heart Failure J.M. Barcelo, J. Segovia, M. Gomez-Bueno, P. Garcia-Pavia, M. Cobo, E. Sufrate, J. Mirelis, L. Alonso-Pulpon Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain Purpose: It is well established that the right ventricular dysfunction (RVD) is a powerful predictor of mortality in patients with heart failure. However, the additive prognostic value of RVD and pulmonary artery hypertension (PAH) is not well known. The aim of this study was to evaluate multiple RVD and PAH parameters that allowed an easy risk stratification of patients with symptomatic heart failure
Methods and Materials: The post-transplant outcome of 485 (82%) elective, 64 (11%) LVAD (DeBakey, Duraheart, Heartware LVAD) and 43 (7%) urgent patients (HU) undergoing cardiac transplantation between January 1998 and May 2008 was retrospectively analyzed. Survival, incidence of rejection, severe infections, CMV-disease and graft vasculopathy (CAV) were compared. All patients received immunosuppressive quadruple therapy consisting of thymoglobuline, Tac/Cyclo⫹MMF/Evl and low dose steroids. Kaplan-Meier analysis was performed to test differences between the groups. Results: Patients in the three groups were comparable with regard to primary disease. Urgent patients were younger (42⫾16yrs) than elective (52⫾13yrs) and LVAD (50⫾11yrs) patients (p⬍.001). Actuarial survival of elective (80%, 75%, 72%), LVAD (84%, 77%, 71%) and HU (81%, 78%, 71%) patients was comparable 1, 3 and 5 years post-transplant (log-rank .671). Furthermore, freedom from rejection episodes (elective: 91%, 90%, 90%, LVAD: 90%, 90%, 90%, HU: 93%, 93%, 93%; log-rank .991), severe infections (elective: 73%, 68%, 67%, LVAD: 84%, 82%, 82, HU: 73%, 73%, 70%; log-rank .118), CMV disease (elective: 91%, 90%, 90%, LVAD: 92%, 92%, 92%, HU: 86%, 86%, 86%; log-rank .415) and CAV (elective: 97%, 92%, 85%, LVAD: 96%, 89%, 83%, HU: 94%, 82%, 82%; log-rank .317) was comparable between elective, LVAD and HU patients 1, 3, and 5 years post-transplant respectively. Conclusions: Despite the increased risk of LVAD and urgent patients post-transplant outcome is excellent and compares to elective patients. The low incidence of rejections and CAV underlines the importance of induction therapy and individualized immunosuppression. 573 Normalization of Fixed Pulmonary Hypertension in Severe Heart Failure Patients with Placement of Left Ventricular Assist Device R. Zolty1, T. Vittorio1, B. Lowes2, S. Shakar2, A. Brieke2, A. Cannon2, J. Cleveland2, D. D’Alessandro3, D. Goldstein3, S. Maybaum3 1Albert Einstein College of Medicine, Bronx, NY; 2 University of Colorado Health Sciences Center, Aurora, CO; 3 Montefiore Medical Center, Bronx, NY Purpose: Fixed pulmonary hypertension in severe heart failure (HF) patients is an absolute contraindication to cardiac transplantation. The purpose of this study was to evaluate the effect of left ventricular assist device (LVAD) on pulmonary artery pressures and pulmonary vascular resistance (PVR) in patients with severe HF and fixed pulmonary hypertension non-responsive to pulmonary vasodilators and/or inotropic agents. Fixed pulmonary hypertension is defined as elevated pulmonary pressures, with a trans-pulmonary gradient ⬎15mmHg, Pulmonary Vascular Resistance (PVR) ⬎5mmHg and PA diastolic-wedge gradient⬎7mmHg, not reversible with pharmacologic agents. Methods and Materials: 12 patients with severe HF (8 non-ischemic, 4 ischemic cardiomyopathy), left ventricular ejection fraction ⬍25% and fixed pulmonary hypertension (PA systolic 66⫾7 mmHg and PVR 7.6⫾0.7 WU) underwent placement of LVAD. These patients were prospectively studied for reassessment of their hemodynamics and pulmonary artery pressures at 1 to 3 months post LVAD implantation. Results: The placement of LVAD (8 HM XVE, 4 HM II) resulted in statistical improvement of pulmonary pressures and PVR . Subsequently, all these patients were successfully transplanted with no development of RV failure after transplantation. Conclusions: Patients with severe HF and fixed pulmonary hypertension may benefit from LVAD implantation with normalization of their pulmonary pressures and may therefore subsequently be listed for orthotopic heart transplantation.
Abstracts
S265
Pulmonary Arety Pressures Improvement After Placement of LVAD Devices in 12 Patients with Fixed Pulmonary Hypertension PA PA mean Wedge Cardiac PVR systolic diastolic PA Mean Output (Wood (mmHg) (mmHg) (mmHg) Pressure (L/min) Units) (mmHg) Baseline 66⫾7 Post LVAD 36⫾2 placement P-value 0.0187* (compared to baseline)
36⫾1 14⫾4
48⫾2 23⫾2
24⫾1 13⫾2
3.1⫾0.1 7.6⫾0.7 5⫾0.6 2.2⫾0.2
0.0035*
0.0023*
0.0155*
0.028*
0.0023*
574 Sildenafil or Bosentan in Patients Considered Inelegible for Heart Transplantation Because of Severe Pulmonary Hypertension M. Farrero, F. Perez-Villa, A. Arias, A. Sionis, A. Castel, E. Roig Thorax Institut. Hospital Clinic., Barcelona, Spain Purpose: Elevated pulmonary vascular resistance (PVR) is associated to an increase in mortality in the early post-heart transplant period, mainly due to right ventricle dysfunction. This study aims to assess the effectiveness of both sildenafil and bosentan in decreasing the PVR in a group of patients initially considered ineligible for heart transplantation because of severe pulmonary hypertension. Methods and Materials: Sixteen patients with end-stage congestive heart failure and severe pulmonary hypertension were prospectively included. These were randomly assigned to receive either bosentan (125 mg bid) or sildenafil (80 mg tid). A second right heart catheterization was performed after 16 weeks of therapy. Results: No significant differences were observed in the two group’s basal characteristics. The bosentan group (n⫽7) had a basal transpulmonary gradient (TPG) of 21 ⫾6 mmHg that was reduced to 10 ⫾ 7 (p⫽0.005) during the treatment. Also the pulmonary vascular resistance decreased from 5.6 ⫾2.4 Wood units to 2.2 ⫾ 1.5 (p⫽0.003). The sildenafil group (n⫽7) showed a non significative trend towards RVP reduction (4.8 ⫾1.5 vs. 3.29 ⫾1.1; p⫽0,053) and TPG decrease (21 ⫾4 vs. 19 ⫾6; p⫽NS). TPG reduction was greater with bosentan (10.5 ⫾5 vs. 4.5 ⫾2mmHg, bosentan vs sildenafil; p⫽0.04). Treatment was stopped in 1 patient of each group due to intolerance. After treatment, 8 patients (5 bosentan, 3 sildenafil) were listed for heart transplantation and 6 of them (4 bosentan, 2 sildenafil) have already been transplanted successfully. Conclusions: Bosentan and sildenafil reduce RVP in patients considered ineligible for heart transplantation due to pulmonary hypertension, allowing them to be transplanted with good results. In our study, bosentan showed to be more effective than sildenafil in decreasing TPG and PVR. 575 Prognostic Value of Right Ventricular Dysfunction and Pulmonary Artery Hypertension Parameters for Risk Stratification of Patients with Heart Failure J.M. Barcelo, J. Segovia, M. Gomez-Bueno, P. Garcia-Pavia, M. Cobo, E. Sufrate, J. Mirelis, L. Alonso-Pulpon Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain Purpose: It is well established that the right ventricular dysfunction (RVD) is a powerful predictor of mortality in patients with heart failure. However, the additive prognostic value of RVD and pulmonary artery hypertension (PAH) is not well known. The aim of this study was to evaluate multiple RVD and PAH parameters that allowed an easy risk stratification of patients with symptomatic heart failure