Outcomes from 100 patients treated with implantable LVAD therapy: are we ready for destination therapy?

Outcomes from 100 patients treated with implantable LVAD therapy: are we ready for destination therapy?

The Journal of Heart and Lung Transplantation Volume 22, Number 1S scale (RFSS) was developed. The distribution of patients for each score revealed th...

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The Journal of Heart and Lung Transplantation Volume 22, Number 1S scale (RFSS) was developed. The distribution of patients for each score revealed that with a RFSSⱖ7, all patients would be allocated to the “poor” group. Conclusion: ECMO could work as a route to select more suitable patients for VAD or HTx. The RFSS is statistically valid to screen for survival likelihood and the chance for future transplantations and helping further decision-making.

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failure (2) or CVA (1) and three patients remain ongoing with IVAD support. Conclusion: Early clinical experience suggests that the Thoratec IVAD can successfully support patients as a bridge to transplantation or for myocardial recovery. Preliminary data also suggests an improvement in the incidence of serious adverse events and patient outcome compared to earlier PVAD trials. 391 PERIOPERATIVE USE OF NESERITIDE IN HEART FAILURE PATIENTS UNDERGOING IMPLANTATION OF LEFT VENTRICULAR ASSIST DEVICE B. Radovancevic,1 B. Vrtovec,1 A.P. Yazdanbakhsh,1 P.A. Odegaard,2 C.D. Thomas,1 R.M. Delgado,1 O.H. Frazier,1 1Cardiopulmonary Transplantation, Texas Heart Institute, Houston, TX; 2Transplant Service, St. Luke’s Episcopal Hospital, Houston, TX

390 INITIAL CLINICAL EXPERIENCE WITH THE THORATEC IVAD: A VERSATILE IMPLANTABLE UNI- OR BI-VENTRICULAR ASSIST DEVICE S. Tsui,1 M. Slaughter,2 J. Hill,3 N. Burton,4 R. Ko ¨rfer,5 1Department of Cardiothoracic Surgery, Papworth Hospital, Cambridge, United Kingdom; 2Department of Cardiothoracic Surgery, Christ Hospital and Medical Center, Chicago, IL; 3Department of Cardiothoracic Surgery, California Pacific Medical Center, San Francisco, CA; 4Department of Cardiothoracic Surgery, Inova Fairfax Hospital, Falls Church, VA; 5 Department of Cardiothoracic Surgery, Heart Center NRW, Bad Oeynhausen, Germany Purpose: The Thoratec implantable ventricular assist device (IVAD) utilizes the same internal working components and geometry as the Thoratec paracorporeal blood pump (PVAD), but has a titanium alloy outer housing. Similar to the PVAD, the IVAD can also be placed externally and can be powered by the TLC-II portable driver (TLC-ll). The initial clinical experience with the IVAD was studied. Methods: Between October 2001 and September 2002, 10 males and 3 females at five institutions [median age: 52 yrs (18-66 yrs)] were supported with the IVAD and TLC-II as a bridge to cardiac transplantation (10) or for postcardiotomy failure (3). Before implantation, all patients were NYHA functional class IV refractory to maximal medical management. Nine patients required LVAD support and 4 patients required BIVAD support. Results: Current cumulative support time is 790 days [mean: 60.8 days; (9-176 days)]. Four patients were discharged home while awaiting cardiac transplantation or myocardial recovery after IVAD durations of 32, 36, 58 and 88 days. One patient required hospital readmission for fever and dehydration after 99 days at home. There were no reported device system failures and no reported embolic events. Severe adverse events occurred in three patients who suffered from bleeding complications (2 re-operations and 1 fatal intracranial bleed). Five patients were successfully bridged to transplantation, two patients weaned from the device, three patients expired on the device from multi-organ

Background: The effects of perioperative nesiritide infusion in heart failure patients undergoing left ventricular assist device (LVAD) implantation have not been studied. Methods: Hemodynamic parameters and kidney and liver function were assessed in 15 LVAD patients in whom nesiritide infusion (0.02 mg/kg/min) was started in the intraoperative period and continued for at least 48 hours thereafter. The medication-matched control group included 15 LVAD patients who were treated with a comparable perioperative regimen that did not include nesiritide (epinephrine in 46%, norepinephrine in 13%, dopamine in 50%, vasopressin in 48%, and milrinone in 48% of patients). Results: Nesiritide-treated patients (Gr I) and controls (Gr II) did not differ in age (52 ⫾ 13 years in Gr I vs. 54 ⫾ 13 years in Gr II, p⫽0.7), gender (male: 93% in Gr I vs. 80% in Gr II, p⫽0.6), heart failure etiology (ischemic: 40% in Gr I vs. 60% in Gr II, p⫽0.3), or LVAD type (Gr I: 8 Jarvik 2000™, 7 TCI HeartMate™; Gr II: 5 Jarvik 2000™, 10 TCI HeartMate™, p⫽0.5). Within the first 48 hours after LVAD implantation mean pulmonary artery pressures (PAP) and pulmonary capillary wedge pressures (PCW) declined more in Gr I than in Gr II (PAP: -9 ⫾ 4 mmHg vs. -4 ⫾ 8 mmHg, p⫽0.03; PCW: -11 ⫾ 5 mmHg vs. -5 ⫾ 3 mmHg, p⫽0.003). Although changes in cardiac index were similar in both groups (⫹1.14 ⫾ 0.44 l/min/m2 in Gr I vs. ⫹1.02 ⫾ 0.48 l/min/m2 in Gr II, p⫽0.12), the improvement in renal function was more pronounced in Gr I (BUN: -13 ⫾ 10 mg/dl in Gr I vs. ⫹0.9 ⫾ 9 mg/dl in Gr II, p⫽0.001; creatinine: -0.56 ⫾ 0.49 mg/dl in Gr I vs. ⫹0.02 ⫾ 0.32 mg/dl Gr II, p⫽0.001). No difference in systemic pressures and liver function between groups was found. Conclusions: Perioperative infusion of nesiritide in patients undergoing LVAD implantation has beneficial effects on hemodynamics and renal function without affecting systemic arterial pressure. 392 OUTCOMES FROM 100 PATIENTS TREATED WITH IMPLANTABLE LVAD THERAPY: ARE WE READY FOR DESTINATION THERAPY? I.A. Smolens,1 H.J. Patel,1 S. Wright,1 D.B. Dyke,2 K.D. Aaronson,2 F.D. Pagani,1 1Section of Cardiac Surgery, University of Michigan, Ann Arbor, MI; 2Division of Cardiology, University of Michigan, Ann Arbor, MI Background: Implantable LVAD therapy is the preferred means to bridge pts in severe refractory heart failure or shock. Indications for LVAD implant are currently being expanded to include patients for destination therapy. We evaluated outcomes from pts undergoing

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LVAD implant to assess utilization of medical resources and to identify areas for quality improvement. Methods: A prospective evaluation of outcomes was performed in 100 pts (median age 52 yrs; 80% male) undergoing HeartMate LVAD implant as a bridge to transplant (n⫽96) or destination therapy (4). Results: LVAD survival was 83⫾4% at 1, 6, and 11 months, 66⫾15% at 1 year and 42⫾21% out to 2.2 years. There were 19 deaths (17 deaths ⬍19 days and 2 deaths @ 335, 463 days). Deaths were attributed to right-sided circulatory failure or multisystem failure (14), device malfunction (1); CVA (1); technical (1); hemorrhage (1), and self-directed withdrawal of care (1). Freedom from major device failure was 86⫾6% at 6 months, 48⫾21 at 1 yr, and 0% at 1.4 yrs. The median postop LOS for the index admission was 22 days. Sixty-one percent were discharged home on LVAD support (82% of the last 50 pts). Forty-five percent of pts discharged required readmission (median 9.5 days / pt). Freedom from readmission was 50% at 72 days. Of the total of 10,971 days of LVAD support, 949 (8.7%) were ICU, 3280 (29.9%) were in-patient non-ICU, and 6742 (61.5%) were at home (last 50 pts (6795 days of support), 437 were ICU (6.4%), 1050 in-patient non-ICU (15.5%), and 5308 (78%) at home). Conclusions: LVAD therapy results in meaningful 1 year survival. Early deaths attributable to right-sided circulatory or multisystem organ failure account for the majority of deaths year 1. Utilization of in-patient hospital services and significant incidence of device failure remain critical areas for improvement. Better candidate selection with earlier operation in suitable patients may improve early mortality and also reduce the requirment for in-patient services. 393 THE RISK OF THROMBOEMBOLISM WITH THE NOVACOR LEFT VENTRICULAR ASSIST DEVICE J.G. Rogers,1 G.A. Ewald,1 C.M. Hanselman,1 K.S. Shelton,1 M.K. Pasque,2 1Cardiology, Washington University School of Medicine, St. Louis, MO; 2Cardiothoracic Surgery, Washington University School of Medicine, St. Louis, MO Mechanical circulatory support is associated with a risk of thromboembolism (TE). The TE incidence is related to surgical technique, the anticoagulation regimen, device characteristics, pump flows, and device infection. The TE rate of the Novacor left ventricular assist device (LVAD) has been reported to be higher than observed with other devices. Methods: We retrospectively analyzed our experience with 30 Novacor LVAD recipients. The mean age was 46 ⫾ 15 years and 7 were female. This population was supported for a cumulative 6,310 days and the mean duration of support was 210 days (range 4 - 1052). A single surgeon implanted all devices. The patients (pts) received warfarin (target INR⫽2.5-4.0) and aspirin. Patients with a TE on this regimen also received clopidogrel 75 mg daily. Results: Seven pts (23%) had 13 TEs during LVAD support. Six pts had 10 TIAs and 2 pts had 3 CVAs. One pt had a peripheral embolus. There were no fatal TEs. One CVA resulted in a right-sided sensory-motor deficit and expressive aphasia that did not limit daily function. The other pt had 2 CVAs that resulted in left upper extremity motor and sensory loss that improved to the point that the extremity could be used. The TE incidence in this experience was 0.81/pt-yr of support. The CVA rate was 0.12/pt-yr of support. The TE risk was not predicted by the relative degree of anticoagulation. The event day INRs were not statistically different from those obtained during the 6-month period that surrounded the TE. No TE was associated with device infection. The TE patients had a lower body surface area (1.83 vs. 2.02, p⫽0.04) and lower pump flows (l/min) than patients without TE (0-6 months:

The Journal of Heart and Lung Transplantation January 2003 5.14 vs. 5.77, p⫽0.04; 6-12 months: 5.33 vs. 6.14, p⫽0.03; and ⬎12 months: 5.32 vs. 6.43, p⫽0.02). Conclusions: The use of the Novacor LVAD is associated with a defined TE risk. However, the risk of a TE that results in permanent neurological dysfunction is low and appears to be best predicted by low pump flows. 394 SERIOUS ABDOMINAL COMPLICATIONS OF INTRAPERITONEAL PLACEMENT OF LEFT VENTRICULAR ASSIST DEVICES P. Tansley, E. Birks, P. McDonald, M. Hipkin, J. Hardy, C. Bowles, N. Banner, A. Khaghani, M. Yacoub, Cardiothoracic Surgery, Harefield Hospital, Harefield, Middlesex, United Kingdom Prolonged use of left ventricular assist devices (LVAD) is valuable in end stage heart failure, but is associated with serious abdominal complications for which little data is currently available. Since 1995 we have implanted LVADs in 67 patients of which 22 in a recovery program were prospectively monitored. Emergency intraperitoneal implantation of 21 HeartMate I and 1 HeartMate II was performed in 18 males and 4 females (15-58 years) with deteriorating end stage dilated cardiomyopathy (NYHA IV) of idiopathic 19 (86%), post-chemotherapy 1 (5%) and post-partum 2 (9%) aetiologies. Mean⫾sd weights, heights and body surface areas were 78⫾16.9kg, 174⫾10.4cm, and 1.93⫾0.26m2 respectively. Variables relating to patients, disease and implantation procedure were examined. Minor complications in 7 (32%) comprised early satiety, distension, nausea & vomiting, driveline infection and failure to gain weight. Major complications threatening myocardial recovery occurred in 8 (36%) including wound infections & dehiscence 2 (9%), compression & gastrointestinal haemorrhage 1 (5%), obstruction 3 (14%) & abscess formation 1 (5%) and perforation & fistulae 2 (9%). A combination of severe infective and bowel complications required emergency explantation in 2 (9%) and caused 1 death. Septic LVAD damage in 1 (5%) required device replacement. Small abdominal volumes predisposed to obstruction, fistulae and haemorrhage. Driveline infection correlated with progressive intraabdominal infection, larger patients being more susceptible. Age did not affect the incidence of complications, but all major complications were in males. Severe abdominal complications are common and can adversely affect morbidity, quality of life and mortality. This warrants active preventative measures. 395 CARDIAC RHYTHM DURING AND AFTER EXPLANTATION OF LEFT VENTRICULAR ASSIST DEVICES (LVAD) USING THE HAREFIELD RECOVERY PROGRAMME J. Hardy, P. Tansley, E. Birks, M. Hipkin, A. Khaghani, N. Banner, M. Yacoub, Cardiothoracic Surgery, Harefield Hospital, Harefield, Middlesex, United Kingdom Ventricular arrhythmias and sudden death are common in dilated cardiomyopathy (DCM). LVADs induce specific haemodynamic changes with near complete unloading of the left heart combined with a possible overload of the right heart. The influence of this haemodynamic paradox on cardiac rhythm, and whether myocardial recovery and device explantation leads to reduction in arrhythmias was studied. Holter recordings were examined in 15 patients undergoing LVAD(HeartMate 1 and 2) and pharmacologic therapy for DCM, mean duration of implantation 311 days. Recordings were also examined in 10