Biomedical subjects

Robert Jarvik

Publications and source records attributed to Robert Jarvik.

6 recordsLinked to original sources

PubMed2006

Mechanical reliability of the Jarvik 2000 Heart.

BACKGROUND: Device failure is a limitation of permanent mechanical circulatory support. We studied the mechanical reliability of the Jarvik 2000 Heart, an axial flow pump with ceramic bearings designed to provide more than 10 years' durability. METHODS: The Jarvik 2000 Heart was implanted in 102 patients between April 2000 and December 2004. Eighty-three pumps with an abdominal driveline were implanted as a bridge-to-transplantation, and 19 with postauricular power supply as lifetime therapy. Eighteen pumps were recovered intact after clinical use and run continuously on the bench to further assess durability. RESULTS: No implantable component failure occurred either in patients or during bench testing. The cumulative pump run-time was 110 years: 59 years overall in vivo and 51 years in vitro. The mean support time for bridge-to-transplant recipients was 159 days, and for discharged lifetime-therapy recipients 551 days. Six recipients were supported moer than 2 years, with the longest ongoing approaching 5 years. External cables caused three system failures, with a 95% freedom from system failure at 4 years. Device malfunctions, related to external cables (9) and lack of a backup battery (1), caused no adverse consequences. Before introduction of noncorrosive, gold-plated stainless steel connectors, corrosion was observed on three connectors to the retroauricular power supply. CONCLUSIONS: The Jarvik 2000 Heart has had no implantable component failure. Meaningful durability data and failure mode can only be established by real-time testing in patients. The reliability and dependability of this device, in addition to the exchangeability of external components, give promise for long-term circulatory support in critically ill heart failure patients.

Equipment Failure Analysis↗

PubMed2002

Initial clinical experience with the Jarvik 2000 implantable axial-flow left ventricular assist system.

BACKGROUND: Implantable left ventricular assist systems (LVASs) are used for bridging to transplantation, bridging to myocardial improvement, and for permanent circulatory support. Conventional implantable systems have inherent limitations that increase morbidity during support. In contrast, small, efficient, axial-flow pumps, which have been under development for the past decade, have the potential to improve the length and quality of life in patients with severe heart failure. Methods and Results- To assess the safety and clinical utility of the Jarvik 2000, we implanted this device in 10 transplant candidates (mean age 51.3 years) in New York Heart Association (NYHA) class IV. Implantation was achieved through a left thoracotomy during partial cardiopulmonary bypass. The mean support period was 84 days. Within 48 hours postoperatively, the cardiac index increased 43%, pulmonary capillary wedge pressure decreased 52%, systemic vascular resistance decreased significantly, and inotropic support became unnecessary. Eight patients underwent physical rehabilitation and returned to NYHA class I. Their left ventricular dimensions, cardiothoracic ratios, and pressure-volume loop analyses showed good left ventricular unloading. Seven patients underwent transplantation and 3 died during support. No device thrombosis was observed at explantation. CONCLUSIONS: The Jarvik 2000 functions as a true assist device by partially unloading the left ventricle, thereby optimizing the patient's hemodynamics. Our preliminary results indicate that this LVAS may safely provide circulatory assistance for heart transplant candidates.

Adult↗

PubMed2002

Circulatory support for long-term treatment of heart failure: experience with an intraventricular continuous flow pump.

BACKGROUND: A lifetime mechanical solution for advanced heart failure must be reliable, with a low risk of life-threatening complications. After extensive laboratory testing, we began clinical trials with an axial flow pump for long-term treatment of New York Heart Association class IV, transplant-ineligible patients. METHODS AND RESULTS: The Jarvik 2000 is a continuous flow device that is implanted in the apex of the left ventricle with offloading to the descending thoracic aorta. Skull-based percutaneous power delivery was derived from cochlear implant technology. We used this system in 4 patients with end-stage dilated cardiomyopathy. Exercise capacity, quality of life, device parameters, and native heart function were monitored serially. One patient died from right heart failure at 3 months. The other patients were discharged from hospital between 3 and 8 weeks postoperatively and are currently New York Heart Association I or II. Follow-up lasted between 9 and 20 months. There has been no device failure or hemolysis. Native heart function and quality of life were markedly improved. CONCLUSIONS: The Jarvik 2000 is a true assist (rather than replacement) device that functions synergistically with the native left ventricle and provides excellent quality of life. Adverse events are infrequent. This blood pump may provide a mechanical solution for end-stage heart failure in the community.

Adrenergic beta-Antagonists↗

PubMed2002

The Jarvik 2000 Heart. Clinical validation of the intraventricular position.

OBJECTIVE: Heart failure is now a public health epidemic. Donor hearts are severely restricted in availability. Permanent mechanical circulatory support or bridge to myocardial recovery are emerging alternatives. After extensive laboratory experience we sought to evaluate the intraventricular Jarvik 2000 Heart in patients with endstage heart failure. METHODS: The Jarvik 2000 Heart is a novel thumb-sized left ventricular assist device (LVAD) which is fitted within the apex of the native left ventricle. A vascular graft off loads this to the descending thoracic aorta. The pump rotor spins at between 8000 and 12,000 rpm providing 5-6 litres blood flow per minute. We have used the device with skull-mounted power delivery for seven permanent implants and trans-abdominal drive line for ten bridge-to-transplant patients. RESULTS: All patients survived the operation. Three died from non-device related complications. Survivors had early resolution of heart failure with return to NYHA I/II. All had pulsatile circulation. The device was user-friendly and imperceptible to the patient. Both the pump and native left ventricle contributed to the cardiac output during exercise. Seven patients have been transplanted successfully. All explanted devices were free from thrombus formation. Two permanent implant patients left hospital as early as 3 weeks postoperatively. CONCLUSIONS: The Jarvik 2000 is an effective user-friendly LVAD which allows early discharge from hospital. The intraventricular position has distinct advantages especially through absence of an inflow cannula. Synergy develops between the LVAD and native left ventricle. Early experience suggests that this may be a realistic LVAD to treat heart failure routinely in the outpatient setting.

Adult↗

PubMed2002

Postauricular percutaneous power delivery for permanent mechanical circulatory support.

OBJECTIVE: Percutaneous driveline infection continues to detract from both quality and length of life in patients with a left ventricular assist device. We have pursued an alternative route by using a skull-mounted percutaneous pedestal similar to cochlear implant technology. We have now used this method in patients implanted with the Jarvik 2000 heart (Jarvik Heart, Inc, New York, NY) as destination therapy for end-stage (New York Heart Association class IV) heart failure. METHODS: Four men with cardiomyopathy aged 61 to 72 years received the Jarvik 2000 heart with postauricular power delivery for permanent mechanical circulatory support. The power cable was brought through the second posterior intercostal space and routed through the neck to a percutaneous titanium implant screwed to the skull. This joins with the cable to the external controller and battery. RESULTS: In 3 patients the pedestal healed well and remained free from infection up to 1 year. The system was user friendly, and the whole external apparatus is exchangeable. The second patient had a subdural hematoma. This caused us to improve the preparation and modify the implant procedure. CONCLUSION: For widespread use, permanent implantable circulatory support requires a reliable, user-friendly device with freedom from powerline infection. Our early experience with the Jarvik 2000 heart suggests that rigid fixation and the vascularity of scalp skin promote healing and reduce the risk of driveline infection.

Aged↗

PubMedDate not supplied

The effect of intermittent low speed mode upon aortic valve opening in calves supported with a Jarvik 2000 axial flow device.

We assessed the effects of an axial flow left ventricular assist device (LVAD) upon aortic valve opening, pump outflow, and biologic and hematologic parameters when operated in intermittent low speed (ILS) mode. An ILS controller equipped Jarvik 2000 LVAD was implanted in six calves. Pump speed was maintained at 10,000 rpm, and pump outflow was measured throughout the study period (71 +/- 6 days [mean +/- SD]). Hematologic and biochemical parameters were analyzed daily for the first 10 days, weekly for the first month, and biweekly thereafter to monitor for kidney or liver dysfunction, hemolysis, bleeding, or infection. Before study termination, esmolol hydrochloride was infused to induce low cardiac output and totally impair aortic valve opening. Radiopaque cineaortography was performed over 30 second intervals (10 seconds before, 10 seconds during, and 10 seconds immediately after ILS controller activation) to assess the effect of ILS mode upon aortic valve opening. After study termination, major end organs and the major vascular tree were removed and examined macroscopically and histologically for thrombus formation and infarction; the aortic valve was examined for thickening and fusion. All pumps were explanted and examined for thrombus formation. All six calves recovered without surgical or mechanical complications. Hematologic and biochemical parameters did not change significantly between baseline and study termination. The aortic valve successfully opened when ILS mode was activated, even under low cardiac output conditions. No thrombus was detected in the major end organs and vascular tree, except for some small renal infarcts in three calves that did not affect renal function. These results indicate that operating an axial flow LVAD in ILS mode allows aortic valve opening and aortic root washout.

Animals↗