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Minimally-Invasive Implantation of Left Ventricular Assist Devices Improves the Operative Outcome in Adult Patients with Severe Heart Failure
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The Journal of Heart and Lung Transplantation, Vol 32, No 4S, April 2013 Conclusions: Although a challenging cohort, the majority of these complex patients were successfully supported, particularly adolescents with congenital heart disease. 370
Methods and Materials: The study cohort included INTERMACS pts in Profiles 1-3 who were implanted with a continuous flow LVAD (CFLVAD). Kaplan-Meier and hazard multivariable modeling was used to assess survival. Results: 3433 CFLVAD implants (3/2009-3/2012) in Profiles 1-3 were selected where 661 were bridged with TCS and the majority (75%) on an IABP. Pts supported with TCS were more likely to have lower albumin, lower hemoglobin, lower platelet counts, abnormal liver function, lower systemic blood pressures (TCS: 100, non-TCS: 103, po 0.0001), more likely to have coronary artery disease and more likely to require mechanical ventilation. The frequency of TCS within the 3 INTERMACS profiles was: Profile 1 (55%), Profile 2 (17%), and Profile 3 (1%). Pts bridged with TCS had a lower survival. When corrected for the increased disease burden of the pts bridged with TCS, there was no difference in mortality except in profile 3 where TCS was associated with decreased survival (p¼0.004). Conclusions: Despite the use of TCS, outcomes are not improved in high risk pts undergoing implantation of a current-generation left VAD. Clinical studies are necessary to investigate strategies to bridge F1 cardiogenic shock pts to long-term success with LVADs. 369 The Worldwide Use of SynCardia Total Artificial Heart in Patients with Congenital Heart Disease D.L. Morales,1 F. Zafar,1 J.W. Gaynor,2 J.W. Rossano,2 J.L. Jefferies,1 T.D. Ryan,1 J.A. Towbin,1 A. Lorts.1 1Heart Institute, Cincinnati Children’s Hospital, University of Cincinnati School of Medicine, Cincinnati, OH; 2Cardiac Center, Children’s Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia, PA. Purpose: Over the past 3 decades, palliation of children with congenital heart disease (CHD) has been increasingly successful. This has created an ever-growing cohort of adolescents and young adults with congenital heart disease who unfortunately develop heart failure. Mechanically supporting such patients is possible, however, patients who have residual lesions or require multiple procedures (i.e. conduit exchange, valve repair) in order to place a ventricular assist device have a higher risk of morbidity and mortality. In complex patients, the use of the SynCardia total artificial heart (TAH) to avoid multiple procedures may be beneficial. However, the success of the TAH in the CHD cohort has not been reported. Methods and Materials: All patients with congenital heart disease who had the SynCardia TAH implanted from 1986 to 2012 were identified in the Worldwide Syncardia TAH database, which contains 1091 patients. Results: TAH was implanted in 24 patients with CHD (2.2% of total cohort). 25% (6/24) of the CHD patients were adolescents (12-18yo). These TAHs were implanted in 16 institutions around the world [US(9), EU(5) and Canada(2)]. Median age was 28 years [13- 56] and 25% were female. Total days of support were 1476 days with a median of 24 [1-359] days. Overall survival was 62% with a 100% survival in adolescents with CDH. Mortalities occurred in the 1st month of support in 89% (8/9) of cases. Cause of death was multisystem organ failure in 5, pulmonary hemorrhage in 1, not reported in 3. Competing outcomes analysis at 2 months demonstrates 67% of patients had a positive outcome: 34% were still on the TAH, 33% were transplanted, and 33% died.
Minimally-Invasive Implantation of Left Ventricular Assist Devices Improves the Operative Outcome in Adult Patients with Severe Heart Failure S.V. Rojas,1 M. Avsar,1 J.S. Hanke,1 L. Fischer,1 A. Meyer,1 2 L. Repges,1 T. Thoms,1 B. Wiegmann,1 I. Kutschka,1 M. Struber, ¨ A. Haverich,1 J.D. Schmitto.1 1Deparment of Cardiothoracic-, Transplantation- and Vascular Surgery, Hannover Medical School, Hannover, Germany; 2Department of Cardiac Surgery, Heart Centre Leipzig, Leipzig, Germany. Purpose: Left ventricular assist devices (LVAD) are gaining more importance in the treatment of heart failure. The constant development of novel technologies in this field is being reflected by enhanced and considerably miniaturized LVAD-systems. However from a surgical point of view, complications like bleeding or right ventricular failure with liver impairment are still major hurdles in LVAD-therapy. Therefore, we recently developed a novel minimally invasive LVAD implantation technique in order to minimize complication rates and improve operative outcome. Methods and Materials: We reviewed the early outcome of 100 consecutive end-stage heart failure patients (74% male, age 51,6 ⫾ 12,6, DCM 49%, ICM 36%) who recently underwent LVAD (HVAD, HeartWare, USA) implantation in our institution between 2011 and 2012. Patients who were operated conventionally by a median sternotomy (group A; n ¼ 65) were compared to patients receiving a minimal invasive upper hemisternotomy combined with an anterolateral thoracotomy (group B; n ¼ 35). Results: Intra-hospital-mortality was lower in group B (12,3% vs. 8,6%). ICU stay was significantly lower (p o 0,05) in group B (20,2 ⫾ 4,9 days vs. 9,8 ⫾ 2,7 days). Bleeding incidence was also significantly (p o 0,05) lower in group B (18.5% vs. 5,7%). Postoperative glutamate dehydrogenase (GLDH) levels were also significantly (p o 0,05) lower in group B (76,2 ⫾ 238,5 U/L vs. 15,5 ⫾ 52,1 U/L). None of the patients had a pump thrombosis. Conclusions: Our data show that the applied minimally invasive LVADimplantation technique improves the early postoperative outcome by improving survival and reducing bleeding events, liver impairment and postoperative ICU stay of terminal heart failure patients. 371 Advanced Heart Failure Therapy in HIV Positive Patients: Do These Patients Get Equal Treatment? N. Uriel,1 P.C. Colombo,1 M. Yuzefpolskaya,1 S.W. Restaino,1 N. Nahumi,1 J. Han,1 S.S. Thomas,1 A.R. Garan,1 H. Takayama,2 D.M. Mancini,1 Y. Naka,2 U.P. Jorde.1 1Medicine, Columbia University, New York, NY; 2Surgery, Columbia University, New York, NY. Purpose: More than 1 million Americans are currently infected with HIV. This study investigates the position of transplant centers towards advanced heart failure (HF) therapy in HIVþ pts. Methods and Materials: A survey concerning heart transplant (HT) and LVAD implantation protocol and outcome in HIVþ pts was distributed to all American HT centers (103 in US, 8 in Canada). Results: 79% (n¼81) of US and 100% (n¼8) of Canadian centers (100%) responded. A total of 18 HTs were performed in HIVþ pts with excellent outcome (1,3,10 years survival of 100%, 90%, 63%). 92% (n¼82) of the centers never performed HT in HIVþ pts and 57% (n¼51) marked HIVþ as a contraindication. The predominant rationales provided were: 1) high-risk pts should be avoided given the scarcity of organ supply (59%), 2) Immunosuppression required for HT may induce HIV progression to AIDS (51%) and 3) drug interactions may worsen prognosis (49%). 76% (n¼68) have never conducted LVAD implantations in HIVþ pts and 20% marked HIVþ as a contraindication. Overall, 34 LVAD implantations in HIVþ pts
The Journal of Heart and Lung Transplantation, Vol 32, No 4S, April 2013 Conclusions: Although a challenging cohort, the majority of these complex patients were successfully supported, particularly adolescents with congenital heart disease. 370
Methods and Materials: The study cohort included INTERMACS pts in Profiles 1-3 who were implanted with a continuous flow LVAD (CFLVAD). Kaplan-Meier and hazard multivariable modeling was used to assess survival. Results: 3433 CFLVAD implants (3/2009-3/2012) in Profiles 1-3 were selected where 661 were bridged with TCS and the majority (75%) on an IABP. Pts supported with TCS were more likely to have lower albumin, lower hemoglobin, lower platelet counts, abnormal liver function, lower systemic blood pressures (TCS: 100, non-TCS: 103, po 0.0001), more likely to have coronary artery disease and more likely to require mechanical ventilation. The frequency of TCS within the 3 INTERMACS profiles was: Profile 1 (55%), Profile 2 (17%), and Profile 3 (1%). Pts bridged with TCS had a lower survival. When corrected for the increased disease burden of the pts bridged with TCS, there was no difference in mortality except in profile 3 where TCS was associated with decreased survival (p¼0.004). Conclusions: Despite the use of TCS, outcomes are not improved in high risk pts undergoing implantation of a current-generation left VAD. Clinical studies are necessary to investigate strategies to bridge F1 cardiogenic shock pts to long-term success with LVADs. 369 The Worldwide Use of SynCardia Total Artificial Heart in Patients with Congenital Heart Disease D.L. Morales,1 F. Zafar,1 J.W. Gaynor,2 J.W. Rossano,2 J.L. Jefferies,1 T.D. Ryan,1 J.A. Towbin,1 A. Lorts.1 1Heart Institute, Cincinnati Children’s Hospital, University of Cincinnati School of Medicine, Cincinnati, OH; 2Cardiac Center, Children’s Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia, PA. Purpose: Over the past 3 decades, palliation of children with congenital heart disease (CHD) has been increasingly successful. This has created an ever-growing cohort of adolescents and young adults with congenital heart disease who unfortunately develop heart failure. Mechanically supporting such patients is possible, however, patients who have residual lesions or require multiple procedures (i.e. conduit exchange, valve repair) in order to place a ventricular assist device have a higher risk of morbidity and mortality. In complex patients, the use of the SynCardia total artificial heart (TAH) to avoid multiple procedures may be beneficial. However, the success of the TAH in the CHD cohort has not been reported. Methods and Materials: All patients with congenital heart disease who had the SynCardia TAH implanted from 1986 to 2012 were identified in the Worldwide Syncardia TAH database, which contains 1091 patients. Results: TAH was implanted in 24 patients with CHD (2.2% of total cohort). 25% (6/24) of the CHD patients were adolescents (12-18yo). These TAHs were implanted in 16 institutions around the world [US(9), EU(5) and Canada(2)]. Median age was 28 years [13- 56] and 25% were female. Total days of support were 1476 days with a median of 24 [1-359] days. Overall survival was 62% with a 100% survival in adolescents with CDH. Mortalities occurred in the 1st month of support in 89% (8/9) of cases. Cause of death was multisystem organ failure in 5, pulmonary hemorrhage in 1, not reported in 3. Competing outcomes analysis at 2 months demonstrates 67% of patients had a positive outcome: 34% were still on the TAH, 33% were transplanted, and 33% died.
Minimally-Invasive Implantation of Left Ventricular Assist Devices Improves the Operative Outcome in Adult Patients with Severe Heart Failure S.V. Rojas,1 M. Avsar,1 J.S. Hanke,1 L. Fischer,1 A. Meyer,1 2 L. Repges,1 T. Thoms,1 B. Wiegmann,1 I. Kutschka,1 M. Struber, ¨ A. Haverich,1 J.D. Schmitto.1 1Deparment of Cardiothoracic-, Transplantation- and Vascular Surgery, Hannover Medical School, Hannover, Germany; 2Department of Cardiac Surgery, Heart Centre Leipzig, Leipzig, Germany. Purpose: Left ventricular assist devices (LVAD) are gaining more importance in the treatment of heart failure. The constant development of novel technologies in this field is being reflected by enhanced and considerably miniaturized LVAD-systems. However from a surgical point of view, complications like bleeding or right ventricular failure with liver impairment are still major hurdles in LVAD-therapy. Therefore, we recently developed a novel minimally invasive LVAD implantation technique in order to minimize complication rates and improve operative outcome. Methods and Materials: We reviewed the early outcome of 100 consecutive end-stage heart failure patients (74% male, age 51,6 ⫾ 12,6, DCM 49%, ICM 36%) who recently underwent LVAD (HVAD, HeartWare, USA) implantation in our institution between 2011 and 2012. Patients who were operated conventionally by a median sternotomy (group A; n ¼ 65) were compared to patients receiving a minimal invasive upper hemisternotomy combined with an anterolateral thoracotomy (group B; n ¼ 35). Results: Intra-hospital-mortality was lower in group B (12,3% vs. 8,6%). ICU stay was significantly lower (p o 0,05) in group B (20,2 ⫾ 4,9 days vs. 9,8 ⫾ 2,7 days). Bleeding incidence was also significantly (p o 0,05) lower in group B (18.5% vs. 5,7%). Postoperative glutamate dehydrogenase (GLDH) levels were also significantly (p o 0,05) lower in group B (76,2 ⫾ 238,5 U/L vs. 15,5 ⫾ 52,1 U/L). None of the patients had a pump thrombosis. Conclusions: Our data show that the applied minimally invasive LVADimplantation technique improves the early postoperative outcome by improving survival and reducing bleeding events, liver impairment and postoperative ICU stay of terminal heart failure patients. 371 Advanced Heart Failure Therapy in HIV Positive Patients: Do These Patients Get Equal Treatment? N. Uriel,1 P.C. Colombo,1 M. Yuzefpolskaya,1 S.W. Restaino,1 N. Nahumi,1 J. Han,1 S.S. Thomas,1 A.R. Garan,1 H. Takayama,2 D.M. Mancini,1 Y. Naka,2 U.P. Jorde.1 1Medicine, Columbia University, New York, NY; 2Surgery, Columbia University, New York, NY. Purpose: More than 1 million Americans are currently infected with HIV. This study investigates the position of transplant centers towards advanced heart failure (HF) therapy in HIVþ pts. Methods and Materials: A survey concerning heart transplant (HT) and LVAD implantation protocol and outcome in HIVþ pts was distributed to all American HT centers (103 in US, 8 in Canada). Results: 79% (n¼81) of US and 100% (n¼8) of Canadian centers (100%) responded. A total of 18 HTs were performed in HIVþ pts with excellent outcome (1,3,10 years survival of 100%, 90%, 63%). 92% (n¼82) of the centers never performed HT in HIVþ pts and 57% (n¼51) marked HIVþ as a contraindication. The predominant rationales provided were: 1) high-risk pts should be avoided given the scarcity of organ supply (59%), 2) Immunosuppression required for HT may induce HIV progression to AIDS (51%) and 3) drug interactions may worsen prognosis (49%). 76% (n¼68) have never conducted LVAD implantations in HIVþ pts and 20% marked HIVþ as a contraindication. Overall, 34 LVAD implantations in HIVþ pts