Reduced infection with use of left ventricular assist device (LVAD) as an alternative to transplantation

The Journal of Heart and Lung Transplantation Volume 23, Number 2S

315 THE THORATEC IVAD: A NEW IMPLANTABLE VENTRICULAR ASSIST DEVICE M.S. Slaughter,1 S.S.L. Tsui,2 A. El-Banayosy,3 R.L. Kormos,4 T.B. Icenogle,5 J.D. Hill,6 1Surgery, Cardiothoracic Division, Advocate Christ Medical Center, Oak Lawn, IL; 2Surgery, Papworth Hospital, Cambridge, United Kingdom; 3Surgery, Heart Center NRW, Bad Oeynhausen, Germany; 4Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA; 5Surgery, Sacred Heart Medical Center, Spokane, WA; 6Surgery, California Pacific Medical Center, San Francisco, CA Purpose: The Thoratec IVAD (implantable ventricular assist device) is a new implantable VAD which can be used an an LVAD, RVAD, or BVAD in patients with a BSA as low as 1.3m2. Results of the multi-center trial are reviewed. Methods: Between October 2001 and July 2003, 30 patients at 11 institutions were supported with the Thoratec IVAD. The IVAD is pneumatically driven with the TLC-II portable driver. Nineteen patients required LVAD and 11 patients BVAD support. Indications for implantation included bridge to transplantation (21) and postcardiotomy failure (9). Results: Twenty-one males and 9 females were supported with an average age of 47 yrs (range 16-17 yrs). There was a total of 2265 days (6.2 yrs) of patient support. The average duration of support was 76 days (range 3-266 days). BSA ranged from 1.31 to 2.26 m2. Seven patients were discharged for a total of 737 days at home. There were no pump failures or pump infections. Complications include: 5 TIA’s (17%), 2 (6.7%) driveline infections and 1 (3%) pocket infection. Six patients remain on IVAD support. Of the remaining 24 patients 16 (67%) were either successfully bridged to transplantation (11) or weaned from the device (5). Eight expired while on the device: multi-organ failure (6), hemorrhagic CVA (1) and subdural hematoma after a fall (1). Conclusion: The new Thoratec IVAD is a versatile VAD which can successfully support patients as bridge to transplantation or for postcardiotomy failure both in and out of the hospital. 316 LEFT VENTRICULAR ASSISTANCE WITH AXIAL FLOW PUMPS: CAN WE CONTROL RIGHT VENTRICULAR FUNCTION? M.E.W. Kirsch,1 E. Vermes,1 S. Nakashima,1 T. Farrokhi,1 D.Y. Loisance,1 1Cardiothoracic Surgery, Henri Mondor Hospital, Cre´teil, France Background: Right ventricular (RV) dysfunction after LVAD implantation remains a major problem. Leftward septal shift secondary to left ventricular (LV) unloading is believed to be an important mechanism. Axial flow pump devices allow for controlled LV unloading by adjustment of rotational speed. We wished to evaluate the impact of progressively increased LV unloading on RV function. Patients and Methods: Two patients were implanted with the Incor Berlin Heart威 axial flow pump. Patient 1 had post-ischemic congestive heart failure with preserved RV function (RV area shortening fraction reduction, RVASF ⫽ 45%). Patient 2 had idiopathic dilated cardiomyopathy which affected both ventricles (RVASF ⫽ 25%). Pulmonary vascular resistances reached 3.2 Wood Units in both patients. The pump’s rotational speed was progressively increased from 6000 to 9000 rpm by increments of 500. RV and LV dimensions were assessed by transthoracic echocardiography at each rotational speed after 3 min of equilibration. Each patient was evaluated at three different time points after complete weaning of haemodynamic drugs. Results: Pump flows increased linearly with rotational speed. LV unloading improved at higher speeds as assessed by reduced LV dimensions and rates of aortic valve opening. In patient 1, RV

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end-systolic (RVES) and end-diastolic (RVED) areas remained similar, while RVASF increased with rotational speeds. In patient 2, RVES area remained similar during the whole speed range. However, RVED area and RVASF increased up to a maximum at 8500 rpm, and decreased thereafter. Conclusion: In patients with normal preoperative RV function, increased rotational speed does not compromise RV function. Patients with impaired preoperative RV function need careful adjustment of pump speed in order to optimise RV function.

317 COMPARISON OF NOVACOR AND HEARTMATE VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICES IN A SINGLE INSTITUTION A.V. Kalya,1 A.J. Tector,1 J.D. Crouch,1 F.X. Downey,1 M.L. McDonald,1 D.P. O’Hair,1 A.J. Anderson,1 C.J. Bartoszewski,1 J.D. Hosenpud,1 1Cardiac Transplant Program, St. Luke’s Medical Center, Milwaukee, WI We are unique as a single center to utilize both Novacor Wearable LVAD device (NOV) and Vented Electric HeartMate (HM) devices. We compared the LVAD to heart transplantation (HTx) rates, LVAD related hospitalization, stroke, infection, PRA and blood product transfusion data amongst the NOV and HM system recipients. Methods: 51 pts (42 men, 9 women; 32 to 70 yrs) received HM and 13 pts (12 men, 1 woman; 26 to 65 yrs) received NOV. Results: Mean duration of LVAD support was 3.8 months for HM and 4.6 months for NOV. There were 36 (70.5 %) patients (pts) with HM and 11 pts (84.7 %) with NOV who were either transplanted or waiting for a HTx at the time of data analysis (p ⫽ NS). Hospitalization for strokes occurred in 3 pts (23 %) with NOV and in 1 pt (1.9%) with HM (p ⫽ 0.02). 7 NOV pts (53.8 %) had LVAD related hospitalizations as compared to 20 HM pts (39.2 %) (p ⫽ NS). LVAD related infection occurred in 5 NOV pts (38.4 %) and in 15 HM pts (29.4 %) (p ⫽ NS). The transfusion of red blood cells (RBC), platelets and fresh frozen plasma (FFP) amongst the NOV pts and HM pts were similar at the time of LVAD placement. However at the time of HTx, NOV pts received significantly higher RBC, platelets and FFP use (p ⫽ 0.01, 0.05, and 0.001 respectively) compared to HM pts. Six HM pts were sensitized, 3 underwent Htx after a single negative crossmatch, 2 pts died early post VAD and thus were never activated, and one pt was just activated and has not had a donor identified. No NOV pt was sensitized. Conclusions: The HTx rates, LVAD related hospitalization and infection rates were similar comparing the HM and NOV pts. Stroke was significantly higher in NOV pts as was blood product use at the time of HTx, likely due to the need for and use of chronic anticoagulation. A positive PRA did not appear to clinically impact HM pts in our experience and may not represent true allosensitization. 318 REDUCED INFECTION WITH USE OF LEFT VENTRICULAR ASSIST DEVICE (LVAD) AS AN ALTERNATIVE TO TRANSPLANTATION

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L.W. Miller,1 S.J. Park,2 J.W. Long,3 D.E. Renlund,3 A.J. Boyle,1 M.M. Colvin-Adams,1 1Cardiology, University of Minnesota, Minneapolis, MN; 2Surgery, University of Minnesota, Minneapolis, MN; 3Surgery, LDS Hospital, Salt Lake City, UT Purpose: Serious infection was the leading cause of death in the REMATCH trial which compared the benefit and complications of VAD support versus medical therapy for patients with end stage heart failure who were not eligible for transplantation. During the trial it became apparent that advancements in infection prevention were needed. Two centers had previously adopted novel, extensive approaches to infection prevention. We report the incidence of infection at our two centers and the impact of disseminating a rigorous protocol to others. Methods: 19 patients from the two centers were enrolled in the REMATCH trial and received a HeartMate VE LVAD (Thoratec Corp, California). All patients were managed with rigorous perioperative preventative measures, including broad spectrum, antibiotic prophylaxis, uniquely were managed with abdominal binders for percutanous lead immobilization, and aggressively supported by the medical team. The cumulative days of VAD support in the 19 patients was 11,243 days, with a mean of 592, and a range of 3-1131 days. The patients were similar to the entire cohort from the REMATCH trial. Results: In these two centers the incidence of infection in the 19 patients was: (a) sepsis as cause of death ⫽ 0, (b) all sepsis events ⫽ 3, (c) localized patient infection ⫽ 21, (d) LVAD perc lead exit site infection ⫽ 8, (e) LVAD pocket infection ⫽ 0, (f) LVAD housing/ inflow/outflow tract infection ⫽ 0 and (g) repeat hospitalization for treatment of infection ⫽ 0. After developing an infection prevention protocol incorporating rigorous practices at these two centers, it was disseminated to all REMATCH investigators. This was associated with reduction in incidence of serious infection for the entire REMATCH LVAD cohort (68 patients) from 68% to 41%. Conclusions: This experience demonstrates the importance of rigorous infection prevention protocols, and demonstrates that infection with long-term LVAD support can be minimized.

319 FIRST GERMAN EXPERIENCE WITH THE CARDIOWEST TAHREPORT FROM A SINGLE CENTER A. El-Banayosy,1 L. Arusoglu,1 M. Morshuis,1 L. Kizner,1 P. Sarnowski,1 R. Koerfer,1 1Department of Cardiothoracic Surgery, Heart and Diabetescenter NRW, Bad Oeynhausen, Germany Purpose: Many reports have demonstrated the efficacy of ventricular assist devices (VAD’S) as bridge to cardiac transplantation (BTT). However, there are some limitations-technical and medical-in their use. In some terminally ill patients (pts) the CardioWest TAH is more beneficial than a VAD. For these cases, the application of a TAH might open a new therapy window. We report our experience with 22 pts supported with the CardioWest TAH in our center. Procedures: From October 2001 until June 2003 22 pts (age 17-77 years, mean 46; 4 female, 18 male, mean BSA 1.9) with cardiogenic shock (CS) were supported with the TAH. Etiology of CS was DCM in 6 pts, ICM in 4 pts, postcardiotomy heart-failure in 4 pts, fulminate myocarditis in 3 pts, acute myocardial infarction in 4 pts and primary graft failure in 1 pt. Risk factors emphasizing the severity of the illness were: 54% of pts had previous cardiac surgery, 69% needed IABP support, 59% other mechanical circulatory support, 94% were ventilated, 62% needed CVVH and 56% had recent CPR. Mean total bilirubin was 3.1 mg/dl and mean creatinine 2.1 mg/dl. Results: Almost all pts recovered from multiple organ failure and gained a mobile state, which was limited though to in-hospital treatment due to the large driving console of the CardioWest TAH.

The Journal of Heart and Lung Transplantation February 2004

Duration of support varied from 5-330 days (mean 96). 9 pts (41%) were transplanted, 3 are waiting for HTX (14%) and 10 pts died on the system (45%). Main complicationes were bleeding (18%), liver failure (18%), abdominal complications (14%). Conclusion: The results show the efficacy and safety of the CardioWest TAH as bridging device for the sickest pts. A portable driver would improve quality of life for these pts and allow out-of-hospital treatment, thus widening the indication for a TAH.

320 LUNG TRANSPLANTATION USING LUNGS FROM DONORS 50 YEARS OF AGE AND OLDER S. Fischer,1 P. Struckmeier,1 R. Tessmann,1 A.R. Simon,1 J. Niedermeyer,1 B. Gohrbandt,1 G. Warnecke,1 A. Haverich,1 M. Strueber,1 1Hannover Thoracic Transplant Program, Hannover Medical School, Hannover, NS, Germany A shortage of donors has led to the progressive expansion of criteria for donor selection in lung transplantation. The outcome of lung transplant (LTx) recipients from donors aged 50 years an older is analysed systematically. From 12/2000 to 06/2003, 31 recipients received lungs from donors 50 years of age and older (range 50-64, mean 54 ⫾ 3 years). This group of recipients was compared to 131 patients receiving lungs from donors younger than 50 years of age (range 7-49, mean 32 ⫾ 11 years) during the same time period. Age, recipient gender and indication for transplant did not differ significantly among groups. Also, the numbers of different types of transplants (bilateral or single LTx) performed was equal with 90% bilateral and 10% single LTx procedures in both cohorts. The proportion of smokers (30% vs 29%, p ⫽ 0.1), PaO2 before lung retrieval (420 ⫾ 131 vs 411 ⫾ 100 mmHg, p ⫽ 0,4), and the length of ischemic time (left lung 359 ⫾ 87/right lung 299 ⫾ 93 min vs left lung 339 ⫾ 67/right lung 258 ⫾ 59 min, p ⫽ 0,4 and p ⫽ 0,07, respectively) did not differe significantly between the older and younger donor group. The following posttransplant parameters were also not statistically different among groups: first paO2 at ICU arrival (older donor group: 232 ⫾ 122 vs 270 ⫾ 114 mmHg in the young donor group, respectively; p ⫽ 0,1), mechanical ventilation time (272 ⫾ 374 vs 259 ⫾ 329 hrs, respectively; p ⫽ 0,5) and length of stay in the ICU (14 ⫾ 16 vs 13 ⫾ 14 days, respectively; p ⫽ 0,7). Recipient survival in the older and younger donor group at 30-days, 3, 6 and 12 months was 83,9 ⫾ 7%, 83,9 ⫾ 7%, 79,6 ⫾ 8% and 79,6 ⫾ 8% vs 84,9 ⫾ 3%, 81,4 ⫾ 4%, 79.6 ⫾ 4% and 76,2 ⫾ 4%, respectively; p ⫽ 0,9. Lung grafts from elderly donors have been considered as marginal organs for transplantation. However, this study indicates that transplantation of lungs from carefully selected donors 50 years of age and older may lead to similar short and mid-term outcome compared to lungs from younger donors. The utilization of lungs from elderly donors could help to increase the number of donor organs in lung transplantation. 321 BENEFICIAL EFFECTS OF TUMOR NECROSIS FACTOR CONVERTING ENZYME INHIBITOR ON REIMPLANTATION LUNG INJURY T. Goto,1 A. Ishizaka,2 M. Kohno,1 M. Sawafuji,1 K. Kobayashi,1 1 Department of Surgery, Keio University, Tokyo, Japan; 2 Department of Medicine, Keio University, Tokyo, Japan Despite the well-known pro-inflammatory effects of tumor necrosis factor (TNF), role of TNF in the pathogenesis of lung injury following lung transplantation remains unclear. TNF has two forms with apparently different biological activities, a membrane associated form and a soluble form generated from the membrane-bound protein by proteolytic cleavage with TNF converting enzyme (TACE). TACE