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Total Artificial Heart (TAH): Survival Outcomes, Risk Factors, Adverse Events in Intermacs
Abstracts S95 2( 36) Early Results of Biventricular Support with Durable, Intracorporeal Continuous Flow Centrifugal Ventricular Assist Devices: Analysis from INTERMACS F. Arabia ,1 C.A. Milano,2 C. Mahr,3 E.C. McGee Jr.,4 S. Maltais,5 S.W. Boyce,6 V. Pretorius,7 A.B. Civitello,8 H.R. Mallidi,9 N.A. Mokadam,10 J.E. Rame,11 D.C. Naftel,12 S.L. Myers,12 J.K. Kirklin.12 1Cardiothoracic Surgery, Cedars-Sinai Medical Center, Los Angeles, CA; 2Duke University Medical Center, Durham, NC; 3University of Washington, Seattle, WA; 4Loyola University Medical Center, Maywood, IL; 5Mayo Clinic, Rochester, MN; 6Washington Hospital Center, Washington, DC; 7University of California at San Diego Medical Center, La Jolla, CA; 8Baylor St. Luke’s Medical Center, Houston, TX; 9Brigham and Women’s Hospital, Boston, MA; 10University of Washington Medical Center, Seattle, WA; 11Penn Heart and Vascular Center, Philadelphia, PA; 12University of Alabama at Birmingham, Birmingham, AL. Purpose: The incidence of right ventricular dysfunction requiring RVAD following LVAD implantation has been reported between 5 to 40%. The mortality in this group is higher compared to pts who require LVAD support only and the most effective and safest BiVAD device configuration remains unknown. We aimed to determine the survival outcomes (competing outcomes) and frequency of the most common adverse events in pts with two durable, intracorporeal continuous flow centrifugal pumps for right and left-sided support. Methods: Between Nov 2012 thru June 2015, 38 pts were identified from INTERMACS who received durable, intra-corporeal, continuous flow centrifugal pumps for biventricular support. Pediatric pts were excluded. Mean age was 47 yrs and there were 74% males. The most common primary diagnoses in this cohort were dilated myopathy: idiopathic (37%) and dilated myopathy: ischemic (16%). Results: Nineteen participating ctrs implanted devices in 38 pts, 11 pts died with the device in place, 9 pts received a heart transplant and 18 were alive on support with the RVAD in place. Survival outcomes (alive on device + transplanted) were 68% at 6 months and 62% at 12 months. The LVAD was placed in the LV apex in 91% of the cases and in 9% the location was not specified. The RVAD was placed in the RV in 50%, right atrium in 37%, and in 13% the location was not specified. The most common adverse events included infection in 50%, bleeding in 44%, respiratory failure 31.6%, device malfunction 26.3%, neurological dysfunction 26.3%, renal dysfunction 18.4%, and cardiac arrhythmia in 18.4%. Conclusion: Pts requiring BiVAD support remain a challenge for MCS therapy. The use of durable, intra-corporeal, continuous flow centrifugal pumps for management of advanced biventricular heart failure is associated with high morbidity and mortality. Further investigation of this device configuration is warranted.
Center, Los Angeles, CA; 2University of Texas Health Science Center Houston, Houston, TX; 3Virginia Commonwealth University Medical Center, Richmond, VA; 4Cedars-Sinai Medical Center, Los Angeles, CA; 5University of Alabama at Birmingham, Birmingham, AL. Purpose: The concept of the TAH for the management of advanced heart failure has encountered challenges in its medical mgmt and outcomes. We aim to better understand the pt population with biventricular failure receiving TAH as a BTT, determine outcomes in 3 eras, ascertain effect of implanting ctr on outcomes, and identify adverse events related to this therapy. Methods: Between June 2006 and March 2015 359 pts received 362 TAH (3 pts received a second device) implants as BTT in 44 hospitals in the Intermacs registry. Mean age was 50 yrs and 85% males. The most common primary diagnoses were: 34% Dilated CM, 30% ischemic CM, and 26% other. A total of 210 pts received a heart transplant and 114 pts died while on the device. Mean follow up was 5 mths. Outcome events were analyzed with competing outcomes methods. Results: Outcomes were separated into Era 1 (2006-09), Era 2 (2010-12), and Era 3 (2013-15); ctrs that implanted 1-5, 6-10, and ≥ 11 implants (per year). Intermacs patient profile (IP) 1+2 accounted for 88% of pts in Era 1, 74% in Era 2, & 70% in Era 3. Competing outcome survival at 6 mths were: Era 1, 80%; Era 2, 76%; and Era 3, 67% (Era 1 vs. Era 2, p= .86; Era 1 vs Era 3, p= .24; Era 2 vs Era 3, p= .13). Ctrs that performed ≥ 11 implants experienced survival at 85% 6 mths post implant for pts IP 1 + 2 (1-5 vs 6-10, p= .70; 1-5 vs 11+, p= .0003; 6-10 vs 11+, p= .0009). Baseline characteristic (p < 0.05) TAH vs. LVAD populations were respectively: CVP 17.3 vs. 12.9, IP1 38.7% vs 15.8%, ECMO 12.4% vs. 2.3%, ventilator 19.1% vs. 6.8%. Common AEs included bleeding 47%, resp failure 36%, renal dysf 33.7%, neuro dysf 24.9%, and hepatic dysf 13.5%. Hazard function analysis revealed the following risk factors for death: older age, elevated bilirubin, lower albumin, prior history of cancer and valve surgery. Conclusion: Implanting ctrs with the largest experience (≥ 11) have the best outcomes probably secondary to better experience in pt selection, timing of intervention and mgmt. AE rates appear to be similar when compared to those reported in the LVAD literature.
2( 38) Outcomes of Medical and Surgical Therapy for Patients with Left Ventricular Assist Device Pump Thrombosis D.T. Majure , F.H. Sheikh, S.I. Ahmed, M.E. Rodrigo, R.K. Young, T.I. Elliott, E.J. Molina, S.W. Boyce, S.S. Najjar. MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC.
2( 37) Total Artificial Heart (TAH): Survival Outcomes, Risk Factors, Adverse Events in Intermacs F. Arabia ,1 I. Gregoric,2 V. Kasirajan,3 J.D. Moriguchi,4 D.C. Naftel,5 S.L. Myers,5 J.K. Kirklin.5 1Cardiothoracic Surgery, Cedars-Sinai Medical
Purpose: Pump thrombosis (PT) is one of the feared complications of continuous flow LVADs. Management of PT includes both medical and surgical (urgent transplantation or pump exchange (PE)) therapies. The outcomes of patients with LVADs who experience a PT are not well defined. Methods: We reviewed all patients who were implanted with an LVAD at our center between 1/2010 and 9/2015. PT was defined as LDH or plasma free Hb > 2.5 x upper limit of normal, abnormal increase in power or flows, or abnormal pump sounds or waveforms consistent with PT. Results: During the study period, 278 patients received an LVAD with a mean follow-up of 515±472 days. 32 (11.5%) patients developed a total of 45 PT events. Nine patients had ≥ 2 PT, defined as an event > 30 days following
Center, Los Angeles, CA; 2University of Texas Health Science Center Houston, Houston, TX; 3Virginia Commonwealth University Medical Center, Richmond, VA; 4Cedars-Sinai Medical Center, Los Angeles, CA; 5University of Alabama at Birmingham, Birmingham, AL. Purpose: The concept of the TAH for the management of advanced heart failure has encountered challenges in its medical mgmt and outcomes. We aim to better understand the pt population with biventricular failure receiving TAH as a BTT, determine outcomes in 3 eras, ascertain effect of implanting ctr on outcomes, and identify adverse events related to this therapy. Methods: Between June 2006 and March 2015 359 pts received 362 TAH (3 pts received a second device) implants as BTT in 44 hospitals in the Intermacs registry. Mean age was 50 yrs and 85% males. The most common primary diagnoses were: 34% Dilated CM, 30% ischemic CM, and 26% other. A total of 210 pts received a heart transplant and 114 pts died while on the device. Mean follow up was 5 mths. Outcome events were analyzed with competing outcomes methods. Results: Outcomes were separated into Era 1 (2006-09), Era 2 (2010-12), and Era 3 (2013-15); ctrs that implanted 1-5, 6-10, and ≥ 11 implants (per year). Intermacs patient profile (IP) 1+2 accounted for 88% of pts in Era 1, 74% in Era 2, & 70% in Era 3. Competing outcome survival at 6 mths were: Era 1, 80%; Era 2, 76%; and Era 3, 67% (Era 1 vs. Era 2, p= .86; Era 1 vs Era 3, p= .24; Era 2 vs Era 3, p= .13). Ctrs that performed ≥ 11 implants experienced survival at 85% 6 mths post implant for pts IP 1 + 2 (1-5 vs 6-10, p= .70; 1-5 vs 11+, p= .0003; 6-10 vs 11+, p= .0009). Baseline characteristic (p < 0.05) TAH vs. LVAD populations were respectively: CVP 17.3 vs. 12.9, IP1 38.7% vs 15.8%, ECMO 12.4% vs. 2.3%, ventilator 19.1% vs. 6.8%. Common AEs included bleeding 47%, resp failure 36%, renal dysf 33.7%, neuro dysf 24.9%, and hepatic dysf 13.5%. Hazard function analysis revealed the following risk factors for death: older age, elevated bilirubin, lower albumin, prior history of cancer and valve surgery. Conclusion: Implanting ctrs with the largest experience (≥ 11) have the best outcomes probably secondary to better experience in pt selection, timing of intervention and mgmt. AE rates appear to be similar when compared to those reported in the LVAD literature.
2( 38) Outcomes of Medical and Surgical Therapy for Patients with Left Ventricular Assist Device Pump Thrombosis D.T. Majure , F.H. Sheikh, S.I. Ahmed, M.E. Rodrigo, R.K. Young, T.I. Elliott, E.J. Molina, S.W. Boyce, S.S. Najjar. MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC.
2( 37) Total Artificial Heart (TAH): Survival Outcomes, Risk Factors, Adverse Events in Intermacs F. Arabia ,1 I. Gregoric,2 V. Kasirajan,3 J.D. Moriguchi,4 D.C. Naftel,5 S.L. Myers,5 J.K. Kirklin.5 1Cardiothoracic Surgery, Cedars-Sinai Medical
Purpose: Pump thrombosis (PT) is one of the feared complications of continuous flow LVADs. Management of PT includes both medical and surgical (urgent transplantation or pump exchange (PE)) therapies. The outcomes of patients with LVADs who experience a PT are not well defined. Methods: We reviewed all patients who were implanted with an LVAD at our center between 1/2010 and 9/2015. PT was defined as LDH or plasma free Hb > 2.5 x upper limit of normal, abnormal increase in power or flows, or abnormal pump sounds or waveforms consistent with PT. Results: During the study period, 278 patients received an LVAD with a mean follow-up of 515±472 days. 32 (11.5%) patients developed a total of 45 PT events. Nine patients had ≥ 2 PT, defined as an event > 30 days following