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Morbidity reduction with the thoratec ventricular assist device (TVAD) for CHF using improved management strategies: a 12 year experience
S148
Abstracts
312 CLINICAL APPLICATION OF A WEAR-RESISTANT AXIAL FLOW PUMP WITH AN INTELLIGENT CONTROL ALGORITHM AS LEFT VENTRICULAR ASSIST DEVIVCE (LVAD) J. Mueller, Y. Weng, T. Drews, D. Kemper, E. Potapov, M. Jurmann, R. Hetzer, Cardiac Surgery, Deutsches Herzzentrum Berlin, Berlin, Germany Since the earliest applications of LVADs, it has always been a goal to obtain a totally wear-free system. INCOR, an axial flow pump for left-heart support, has a virtually unlimited life due to magnetic suspension of the rotating impeller. A control algorithm avoids sucking-in of myocardial tissue and therefore all side effects such as profound arrhythmia. In-pump sensors allow flow adaptation to the patient’s needs. Out of 72 patients supported by the device since June 2002, 31 (1f, 30m; mean age 53, range 36-65 years) with end-stage heart failure received the system at this institute. Anticoagulation consisted of postoperative administration of heparin and of Aspirin, clopidogrel, and Warfarin later on. For dosage adjustment, INR, thrombelastography and platelet aggregometry were performed. Anti-heart-failure medication was administered. A variety of blood chemistry examinations were performed to check for hemolysis. The mean follow-up period is 127 days (range, 12-454); 19 patients are still being supported. It was possible to wean two of the patients because of cardiac improvement after 178 and 206 days, respectively. Two patients received transplants and 8 died due to multi-organ failure after a mean of 49 (range 22-126) days. Three patients showed signs of a TIA and two had cerebral bleeding. Due to the anti-suction algorithm, suction of myocardium with subsequent arrhythmia could not be detected. After 2 months, blood chemistry showed normal values for all organ functions, in particular no hemolysis and no deviations of any blood cell count were observed. None of the patients showed signs of infection (CRP normal). According to the information gained from the in-pump sonsors, an adjustment of the flow to meet the therapeutic goal and the patient’s needs was easily achieved. Application of up-to-date technology in the design of axial flow pumps significantly improves the clinical outcome. Especially the problems resulting from chronic systemic infection seem to have been solved. The in-pump sensor system enables optimization of the treatment. 313 MORBIDITY REDUCTION WITH THE THORATEC VENTRICULAR ASSIST DEVICE (TVAD) FOR CHF USING IMPROVED MANAGEMENT STRATEGIES: A 12 YEAR EXPERIENCE A.N. Patel,1 L. Carroza,1 J. Ristich,1 L. Shears,1 S. Winowich,1 E. Stanford,1 P. Anagnostopoulos,1 R. Kormos,1 1Cardiothoracic Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA Background: Specific strategies were adopted in the past 4 years to prevent thromboembolic and infectious complications using the TVAD in end-stage CHF through staged anticoagulant usage, improved percutaneous driveline care and an aggressive discharge policy. Methods: Analysis of preoperative factors and post-implant adverse events collected prospectively in 113 patients who received TVAD’s over the past 12 years was performed in two groups: Grp 1 implanted before the year 2000 and Grp 2 after January 1, 2000. Freedom from neurologic events (neuro) and driveline (DL) or bloodstream (BS) infections were expressed actuarially at 60 days. Results: Overall utilization of biventricular devices (BiVAD) vs left (LVAD) increased from 56% in Grp 1 to 72% in Grp 2 (*p ⬍ 0.05)
The Journal of Heart and Lung Transplantation February 2004
reflecting acuity of CHF. Neuro events were more commonly seen in females (39%) vs males (16%) * and in patients supported for longer (121 days with neuro event vs 74 days without *). Freedom at 60 days from bloodstream infection in LVAD’s was 100% in Grp 1 vs 90% in Grp 2 and in BiVADs 77% in Grp 1 vs 91% in Grp 2. BS infections were seen in more often in obese patients and those requiring pre-implant ventilatory support*.Patients with DL infection had longer support times (134 days with vs 64 days without*).
N Support Days Pre-Trx Mortality LVAD Pre-Trx Mortality BiVAD Freedom From Neuro Events LVAD Freedom From Neuro Events BiVAD Freedom From DL Infection LVAD Freedom From DL Infection BiVAD
Group 1
Group 2
55 76 12% 35% 59% 61% 65% 48%
58 94 7% 35% 100%* 81% 92%* 92%*
Conclusions: Adoption of new management policies with paracorporeal TVAD’s have resulted in a significant reduction in the rate of neurologic and infectious adverse events especially in patients needing LVAD’s. These results are very favourable for a system which recently has become implantable.
314 EFFECT OF MECHANICAL CIRCULATORY SUPPORT ON OUTCOMES AFTER HEART TRANSPLANTATION IN THE MODERN ERA S.G. Drakos,1 J.W. Long,1 J.C. Stringham,1 E.M. Gilbert,1 S.A. Moore,1 B.D. Horne,1 B.A. Campbell,1 K.E. Nelson,1 D.G. Renlund,1 1 Utah Transplantation Affiliated Hospitals (UTAH) Cardiac Transplant Program, LDS Hospital, University of Utah School of Medicine and Veterans Affairs Medical Center, Salt Lake City, UT We hypothesized that patients (PTS) in the modern era who require mechanical circulatory support (MCS) prior to heart transplantation (TX) have similar outcomes after TX as those not needing MCS. Methods: We retrospectively reviewed 278 PTS who underwent cardiac TX from 1993 to 2002. MCS was required in 72 PTS (HeartMate LVAS in 66; CardioWest Total Artificial Heart in 6) and was not in 206 PTS. Results: Baseline clinical characteristics (age, gender, etiology of heart failure, history of diabetes and donor age and gender) were similar in the two groups. Ischemic time was longer (200 ⫾ 65 vs. 175 ⫾ 67 minutes, p ⫽ 0.009) and perioperative blood product use was greater in the MCS group. One-month and 1-year survival after TX did not differ between the groups (MCS: 92% and 85%, respectively vs. non-MCS: 97% and 92%, respectively). Similar percentages of patients were free from rejection (ISHLT score ⱖ 3A) at 1 year of follow-up (MCS: 56% vs. non-MCS: 52%, p ⫽ 0.60). No difference was observed between MCS and non-MCS groups in other post-TX events, such as hospital stay (14.5 ⫾ 15.0 vs. 14.7 ⫾ 14.7 days), ICU stay (8.5 ⫾ 8.1 vs. 8.4 ⫾ 8.6 days), extubation time (68.4 ⫾ 157 vs. 61.1 ⫾ 188 hours), acute allograft dysfunction (6.9% vs. 4.7%), re-operation rates (6.9% vs. 4.1%), acute renal dysfunction (5.5% vs. 12.4%), acute hepatic dysfunction (20.8% vs. 17.7%), infections (15.3% vs. 22.5%), arrhythmias (5.5% vs. 11.2%), thromboembolic complications (5.5% vs. 7.7%), neurologic complications (9.7% vs. 7.7%), gastrointestinal complications (8.3% vs. 5.3%) and cardiac allograft vasculopathy (1.4% vs. 4.1%). The incidence of chronic renal insufficiency was lower in the MCS group (15.3% vs. 37.9%, p ⫽ 0.001). Conclusion: Post-TX outcomes after pre-TX use of MCS are similar to those when MCS is not required. When hemodynamically indicated, inordinate deferral of pre-TX MCS should be avoided.
Abstracts
312 CLINICAL APPLICATION OF A WEAR-RESISTANT AXIAL FLOW PUMP WITH AN INTELLIGENT CONTROL ALGORITHM AS LEFT VENTRICULAR ASSIST DEVIVCE (LVAD) J. Mueller, Y. Weng, T. Drews, D. Kemper, E. Potapov, M. Jurmann, R. Hetzer, Cardiac Surgery, Deutsches Herzzentrum Berlin, Berlin, Germany Since the earliest applications of LVADs, it has always been a goal to obtain a totally wear-free system. INCOR, an axial flow pump for left-heart support, has a virtually unlimited life due to magnetic suspension of the rotating impeller. A control algorithm avoids sucking-in of myocardial tissue and therefore all side effects such as profound arrhythmia. In-pump sensors allow flow adaptation to the patient’s needs. Out of 72 patients supported by the device since June 2002, 31 (1f, 30m; mean age 53, range 36-65 years) with end-stage heart failure received the system at this institute. Anticoagulation consisted of postoperative administration of heparin and of Aspirin, clopidogrel, and Warfarin later on. For dosage adjustment, INR, thrombelastography and platelet aggregometry were performed. Anti-heart-failure medication was administered. A variety of blood chemistry examinations were performed to check for hemolysis. The mean follow-up period is 127 days (range, 12-454); 19 patients are still being supported. It was possible to wean two of the patients because of cardiac improvement after 178 and 206 days, respectively. Two patients received transplants and 8 died due to multi-organ failure after a mean of 49 (range 22-126) days. Three patients showed signs of a TIA and two had cerebral bleeding. Due to the anti-suction algorithm, suction of myocardium with subsequent arrhythmia could not be detected. After 2 months, blood chemistry showed normal values for all organ functions, in particular no hemolysis and no deviations of any blood cell count were observed. None of the patients showed signs of infection (CRP normal). According to the information gained from the in-pump sonsors, an adjustment of the flow to meet the therapeutic goal and the patient’s needs was easily achieved. Application of up-to-date technology in the design of axial flow pumps significantly improves the clinical outcome. Especially the problems resulting from chronic systemic infection seem to have been solved. The in-pump sensor system enables optimization of the treatment. 313 MORBIDITY REDUCTION WITH THE THORATEC VENTRICULAR ASSIST DEVICE (TVAD) FOR CHF USING IMPROVED MANAGEMENT STRATEGIES: A 12 YEAR EXPERIENCE A.N. Patel,1 L. Carroza,1 J. Ristich,1 L. Shears,1 S. Winowich,1 E. Stanford,1 P. Anagnostopoulos,1 R. Kormos,1 1Cardiothoracic Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA Background: Specific strategies were adopted in the past 4 years to prevent thromboembolic and infectious complications using the TVAD in end-stage CHF through staged anticoagulant usage, improved percutaneous driveline care and an aggressive discharge policy. Methods: Analysis of preoperative factors and post-implant adverse events collected prospectively in 113 patients who received TVAD’s over the past 12 years was performed in two groups: Grp 1 implanted before the year 2000 and Grp 2 after January 1, 2000. Freedom from neurologic events (neuro) and driveline (DL) or bloodstream (BS) infections were expressed actuarially at 60 days. Results: Overall utilization of biventricular devices (BiVAD) vs left (LVAD) increased from 56% in Grp 1 to 72% in Grp 2 (*p ⬍ 0.05)
The Journal of Heart and Lung Transplantation February 2004
reflecting acuity of CHF. Neuro events were more commonly seen in females (39%) vs males (16%) * and in patients supported for longer (121 days with neuro event vs 74 days without *). Freedom at 60 days from bloodstream infection in LVAD’s was 100% in Grp 1 vs 90% in Grp 2 and in BiVADs 77% in Grp 1 vs 91% in Grp 2. BS infections were seen in more often in obese patients and those requiring pre-implant ventilatory support*.Patients with DL infection had longer support times (134 days with vs 64 days without*).
N Support Days Pre-Trx Mortality LVAD Pre-Trx Mortality BiVAD Freedom From Neuro Events LVAD Freedom From Neuro Events BiVAD Freedom From DL Infection LVAD Freedom From DL Infection BiVAD
Group 1
Group 2
55 76 12% 35% 59% 61% 65% 48%
58 94 7% 35% 100%* 81% 92%* 92%*
Conclusions: Adoption of new management policies with paracorporeal TVAD’s have resulted in a significant reduction in the rate of neurologic and infectious adverse events especially in patients needing LVAD’s. These results are very favourable for a system which recently has become implantable.
314 EFFECT OF MECHANICAL CIRCULATORY SUPPORT ON OUTCOMES AFTER HEART TRANSPLANTATION IN THE MODERN ERA S.G. Drakos,1 J.W. Long,1 J.C. Stringham,1 E.M. Gilbert,1 S.A. Moore,1 B.D. Horne,1 B.A. Campbell,1 K.E. Nelson,1 D.G. Renlund,1 1 Utah Transplantation Affiliated Hospitals (UTAH) Cardiac Transplant Program, LDS Hospital, University of Utah School of Medicine and Veterans Affairs Medical Center, Salt Lake City, UT We hypothesized that patients (PTS) in the modern era who require mechanical circulatory support (MCS) prior to heart transplantation (TX) have similar outcomes after TX as those not needing MCS. Methods: We retrospectively reviewed 278 PTS who underwent cardiac TX from 1993 to 2002. MCS was required in 72 PTS (HeartMate LVAS in 66; CardioWest Total Artificial Heart in 6) and was not in 206 PTS. Results: Baseline clinical characteristics (age, gender, etiology of heart failure, history of diabetes and donor age and gender) were similar in the two groups. Ischemic time was longer (200 ⫾ 65 vs. 175 ⫾ 67 minutes, p ⫽ 0.009) and perioperative blood product use was greater in the MCS group. One-month and 1-year survival after TX did not differ between the groups (MCS: 92% and 85%, respectively vs. non-MCS: 97% and 92%, respectively). Similar percentages of patients were free from rejection (ISHLT score ⱖ 3A) at 1 year of follow-up (MCS: 56% vs. non-MCS: 52%, p ⫽ 0.60). No difference was observed between MCS and non-MCS groups in other post-TX events, such as hospital stay (14.5 ⫾ 15.0 vs. 14.7 ⫾ 14.7 days), ICU stay (8.5 ⫾ 8.1 vs. 8.4 ⫾ 8.6 days), extubation time (68.4 ⫾ 157 vs. 61.1 ⫾ 188 hours), acute allograft dysfunction (6.9% vs. 4.7%), re-operation rates (6.9% vs. 4.1%), acute renal dysfunction (5.5% vs. 12.4%), acute hepatic dysfunction (20.8% vs. 17.7%), infections (15.3% vs. 22.5%), arrhythmias (5.5% vs. 11.2%), thromboembolic complications (5.5% vs. 7.7%), neurologic complications (9.7% vs. 7.7%), gastrointestinal complications (8.3% vs. 5.3%) and cardiac allograft vasculopathy (1.4% vs. 4.1%). The incidence of chronic renal insufficiency was lower in the MCS group (15.3% vs. 37.9%, p ⫽ 0.001). Conclusion: Post-TX outcomes after pre-TX use of MCS are similar to those when MCS is not required. When hemodynamically indicated, inordinate deferral of pre-TX MCS should be avoided.