Midterm experience with the Jarvik 2000 axial flow left ventricular assist device.
ABSTRACT Rotary axial flow pumps have several potential advantages and disadvantages over pulsatile pumps. The Jarvik 2000 is distinctive in being intracardiac. We report our experience in 22 patients.
The Jarvik 2000 was implanted in 15 men and 7 women. Mean age was 38.8 (range 23-59) years, preoperative diagnosis was dilated cardiomyopathy in 16, postpartum cardiomyopathy in 3, ischemic heart disease in 2, and chronic allograft failure in 1. Twenty-one patients were in New York Heart Association class IV, and 1 patient was in class III. Nineteen patients were on inotropic support, 6 were supported with an intra-aortic balloon pump, and 2 patients had been salvaged with a Centrimag (Levitronix) ventricular assist device. The median pulmonary vascular resistance was 3 Wood units; median pulmonary capillary wedge pressure was 26.6 mm Hg; and mean Cardiac Index was 1.5 L/min/m2.
There were 2 early deaths and 6 late deaths. The average postoperative ventilation time and Intensive Treatment Unit stay was 2.2 and 10 days, respectively. One patient required a right ventricular assist device for short-term support and another for medium-term support. Seven patients were bridged to transplant, 3 had myocardial recovery, and 4 are ongoing. Mean and total duration of support was 280.5 and 6172 days, respectively. Driveline failures were noted in 3, but there were no pump infections or failure.
The Jarvik 2000 provides satisfactory intermediate-term results as a bridge to transplant or recovery. It appears to be associated with a low rate of serious driveline or pump infections and technical failure. However, bleeding complications due to the required anticoagulation treatment frequently occurred.
- SourceAvailable from: Pablo Gerardo Sanchez[show abstract] [hide abstract]
ABSTRACT: The infant Jarvik 2000 heart is a very small, hermetically sealed, intracorporeal, axial-flow ventricular assist device (VAD) designed for circulatory support in neonates and infants. The anatomic fit, short-term biocompatibility and hemodynamic performance of the device were evaluated in a neonate piglet model. The infant Jarvik 2000 heart with two different blade profiles (low- or high-flow blade design) was tested in 6 piglets (8.8±0.9 kg). Using a median sternotomy, the pump was placed in the left ventricle through the apex without cardiopulmonary bypass. An outflow graft was anastomosed to the ascending aorta. Hemodynamics and biocompatibility were studied for 6 hours. All 6 pumps were implanted without complication. Optimal anatomic positioning was found with the pump body inserted 2.4 cm into the left ventricle. Hemodynamics demonstrated stability throughout the 6-hour duration. The pump flow increased from 0.27 to 0.95 liter/min at increasing speeds from 18 to 31 krpm for the low-flow blade design, whereas the pump flow increased from 0.54 liter/min to 1.12 liters/min at increasing speeds from 16 krpm to 31 krpm for the high-flow blade design. At higher speeds, >80% of flow could be supplied by the device. Blood chemistry and final pathology demonstrated no acute organ injury or thrombosis for either blade design. The infant Jarvik 2000 heart is anatomically and biologically compatible with an short-term neonate piglet model. This in vivo study demonstrates the future feasibility of this device for clinical use.The Journal of heart and lung transplantation: the official publication of the International Society for Heart Transplantation 01/2013; 32(1):112-9. · 3.54 Impact Factor
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ABSTRACT: Left ventricular assist devices (LVADs) are increasingly being used as a bridge to heart transplantation or destination therapy. It is unclear which antithrombotic regimen should be used to reduce the risk of stroke. We systematically reviewed the literature on all types of antithrombotic regimens and stroke in patients with any type of LVADs. Our primary outcome measure was the mean incidence of any type of stroke. Twenty-six articles were selected as relevant, comprehending 1989 patients with a mean LVAD support of 200 days (range 30-621). The mean proportion of patients affected with stroke was 20% (range 0-55%), with a mean incidence of 0.74 (range 0-6.91) events/patient-year. Support with HeartMate II and a regimen of postoperative heparin converted to coumarins, acetylsalicylic acid (ASA) and dipyridamole resulted in 0.17 (mean; range 0.06-0.29) strokes/patient-year. HeartMate II support and the same regime without heparin was associated with 0.07 (mean; range 0.03-0.11) strokes/patient-year. A Novacor device with heparin, converted to coumarins, was associated with 3.82 (mean; range 1.03-6.91) strokes/patient-year, while ASA added to this regime resulted in 0.97 ischaemic strokes/patient-year (mean; range 0.53-1.48). Other combinations of assist devices and antithrombotic regimes were investigated in one or two studies only. This systematic review provides risk estimates for stroke for various LVADs and antithrombotic regimes. Our findings indicate that the postoperative use of heparin in HeartMate II patients is doubtful, and suggest an important role for antiplatelet drugs to prevent stroke in patients supported with a Novacor device.European journal of cardio-thoracic surgery: official journal of the European Association for Cardio-thoracic Surgery 06/2012; 42(4):612-20. · 2.40 Impact Factor
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ABSTRACT: BACKGROUND: Survival of patients on left ventricular assist devices (LVADs) has improved. We examined the differences in risk of adverse outcomes between LVAD supported and medically managed candidates on the heart transplant waiting list. METHODS AND RESULTS: We analyzed mortality and morbidity in 33,073 heart transplant candidates registered on the United Network for Organ Sharing (UNOS) waiting list between 1999 and 2011. Five groups were selected: patients without LVADs in urgency Status 1A, 1B and 2, patients with pulsatile-flow (PF) and patients with continuous-flow (CF) LVADs. Outcomes in patients requiring biventricular assist devices (BIVADs), total artificial heart (TAH) and temporary VADs were also analyzed. Two eras were defined based on the approval date of the first CF-LVAD for bridge-to-transplant in the US (2008). Mortality was lower in the current compared with the first era - 2.1% vs. 2.9%/month, p<0.0001. In the first era, mortality of PF-LVAD patients was higher than in Status 2 (HR 2.15, p<0.0001) and similar to Status 1B patients (HR 1.04, p=0.61). In the current era, patients with CF-LVADs had similar mortality compared to Status 2 (HR 0.80, P=0.12) and lower mortality compared with Status 1A and 1B patients (HR 0.24 and 0.47, p<0.0001 for both comparisons). However, status upgrade for LVAD-related complications occurred frequently (28%) and increased the mortality risk (HR 1.75, p=0.001). Mortality was highest in patients with BIVADs (HR 5.00, p<0.0001) and temporary VADs (HR 7.72, p<0.0001). CONCLUSIONS: Mortality and morbidity on the heart transplant waiting list have decreased. Candidates supported with contemporary CF-LVADs have favorable waiting list outcomes; however, these worsen significantly once a serious LVAD-related complication occurs. Transplant candidates requiring temporary and biventricular support have the highest risk of adverse outcomes. These results may help to guide optimal allocation of donor hearts.Circulation 12/2012; · 15.20 Impact Factor