David Pigott

Preliminary experience with a novel intraoperative fluorescence imaging technique to evaluate the patency of bypass grafts in total arterial revascularization.

BACKGROUND Early graft failure is a common cause of cardiac morbidity and mortality after coronary artery bypass grafting (CABG), and there is particular concern about graft patency in off-pump CABG. We describe our preliminary experience with a novel imaging technique (the SPY system), based on fluorescence of Indocyanine Green when exposed to near infrared light, for the intraoperative assessment of coronary graft patency. METHODS Graft patency was assessed in patients undergoing off-pump and on-pump total arterial revascularization. The imaging technique requires injection of a 1-mL bolus of Indocyanine Green into the central venous line, followed by imaging with the SPY system. RESULTS We assessed intraoperative graft patency in 213 conduits in 84 patients (mean, 2.54 grafts per patient), of which, 65 (77%) were done off-pump. It took approximately 3 minutes to image each graft. Skeletonized conduits provided better visualization than pedicled ones. Fluorescence, confirming graft patency, was observed in all but four (1.9%) conduits in 4 (5%) patients. In these latter cases, graft revision was necessitated. CONCLUSIONS Fluorescence imaging of coronary grafts using the SPY is a uniquely simple, safe, noninvasive, and reproducible technique for intraoperative confirmation of graft patency. In 4 patients, it necessitated revision of the initial intraoperative procedure. Quantification of graft flow would enhance the value of the system.

First permanent implant of the Jarvik 2000 Heart

BACKGROUND Heart failure is a major public-health concern. Quality and duration of life on maximum medical therapy are poor. The availability of donor hearts is severely limited, therefore an alternative approach is necessary. We have explored the use of a new type of left-ventricular assist device intended as a long-term solution to end-stage heart failure. METHODS As part of a prospective clinical trial, we implanted the first permanent Jarvik 2000 Heart--an intraventricular device with an innovative power delivery system--into a 61-year-old man (New York Heart Association functional class IV) with dilated cardiomyopathy. We assessed the effect of this left-ventricular assist device on both native heart function and the symptoms and systemic characteristics of heart failure. FINDINGS The Jarvik 2000 Heart sustained the patients circulation, and was practical and user-friendly. After 6 weeks, exercise tolerance, myocardial function, and end-organ function improved. Symptoms of heart failure have resolved, and continuous decreased pulse-pressure perfusion has had no adverse effects in the short term. There has been no significant haemolysis and no device-related complications. The skull-mounted pedestal is unobtrusive and has healed well. CONCLUSIONS The initial success of this procedure raises the possibility of a new treatment for end-stage heart failure. In the longer term, its role will be determined by mechanical reliability.

Research and development of an implantable, axial-flow left ventricular assist device: the Jarvik 2000 Heart

Advances in technology and increased clinical need have led to the development of a new type of blood pump. The Jarvik 2000 Heart is an electrically powered, axial-flow left ventricular assist device that has been developed during the past 13 years. Unlike first-generation left ventricular assist devices, which were developed in the 1970s and were designed to totally capture the cardiac output, the Jarvik 2000 is designed to normalize the cardiac output by augmenting the function of the chronically failed heart for extended periods. Design iterations have been tested in 67 animals, and clinical trials have recently begun. Three patients have received the Jarvik 2000 as a bridge to transplantation, and 1 patient is being supported permanently outside the hospital. All 4 patients have improved from New York Heart Association functional class IV to class I, and 2 of them have been discharged from the hospital after heart transplantation. The experimental and clinical results indicate that the Jarvik 2000 can provide physiologic support with minimal complications and is reliable, biocompatible, and easy to implant.

Does furosemide prevent renal dysfunction in high-risk cardiac surgical patients? Results of a double-blinded prospective randomised trial §,§§

OBJECTIVE Renal dysfunction following cardiac surgery is more apparent in high-risk patients with pre-existing renal dysfunction, diabetes and impaired left-ventricular function, and following complicated procedures involving prolonged cardiopulmonary bypass (CPB). The aim of this prospectively randomised double-blinded placebo-controlled study was to evaluate reno-protective effect of low-dose furosemide infusion in this high-risk group. METHODS Patients with preoperative serum creatinine >130 micromol/l (1.4 mg/dl), left-ventricular ejection fraction <50%, congestive heart failure, diabetes, or procedures involving prolonged CPB were randomised to receive either saline at 2 ml/h (n=21), or furosemide at 4 mg/h (n=21). Infusion was commenced after induction of anaesthesia and continued for 12h postoperatively. Renal dysfunction was defined as >50% increase in serum creatinine postoperatively, or >130 micromol/l (1.4 mg/dl), or requirement for haemodialysis, or all of these. In patients with preoperative serum creatinine >130 micromol/l, >50% increase over preoperative levels was used to define postoperative renal dysfunction. RESULTS Following cardiac surgery, patients receiving furosemide had a higher urine output (3.4+/-1.2 ml/kg/h in furosemide group and 1.2+/-0.5 ml/kg/h in placebo group; p<0.001), higher postoperative fluid requirement (4631+/-1359 ml in furosemide group and 3714+/-807 ml in placebo group, p=0.011), and lower urinary-creatinine (2+/-1.3 micromol/l in furosemide group and 5.9+/-2.5 micromol/l in placebo group p<0.001). Both groups had significant increase in retinol binding protein/creatinine ratio (7.2+/-6 to 3152+/-1411 in furosemide group; 4.9+/-2.1 to 2809+/-1125 in placebo group; p<0.001) and peak serum creatinine (98+/-33 to 177+/-123 micromol/l in furosemide group; 96+/-20 to 143+/-87 micromol/l in placebo group; p<0.001), and a significant decrease in peak creatinine-clearance (64.3+/-29.4 to 39.1+/-16.6 ml/min in furosemide group; 65.5+/-38.6 to 41.8+/-17.8 ml/min in placebo group; p<0.001) following cardiac surgery, implying significant renal injury following cardiac surgery. Peak creatinine levels (177+/-123 micromol/l in furosemide group and 143+/-87 micromol/l in placebo group; p=0.35) and peak creatinine-clearance (39.1+/-16.6 ml/min in furosemide group and 41.8+/-17.8 ml/min in placebo group; p=0.61) were similar in the two groups. Importantly, there was no difference in incidence of renal dysfunction between the furosemide group (9/21) and the control group (8/21) (relative risk 1.1, 95% confidence interval 0.6-2.2; p=0.99). CONCLUSIONS Our randomised trial did not demonstrate any benefit of furosemide-infusion postoperatively in high-risk cardiac surgical patients. Although urinary output increased with furosemide, there was no decrease in renal injury, and no decrease in incidence of renal dysfunction.

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.

Jarvik 2000 Heart Potential for Bridge to Myocyte Recovery

BACKGROUND Mechanical bridge to left ventricular recovery is an emerging strategy for the treatment of heart failure. We sought to validate the use of a new intracardiac axial flow impeller pump for this purpose. METHODS AND RESULTS The Jarvik 2000 Heart was implanted into 30 sheep to ascertain mechanical reliability, biocompatibility, and hemodynamic function. We attempted but failed to anticoagulate with warfarin. Elective explants with survival were performed in 3 animals to simulate bridge to recovery. Extensive autopsy studies were performed in all other animals. At speeds between 8000 and 12 000 rpm the device pumped up to 8 L/min, captured all mitral flow, and augmented cardiac output with elevation of mean arterial pressure. The pump was silent and hemolysis negligible. Nonpulsatile flow did not adversely affect neurological or renal function. Device removal proved straightforward and safe. A fractured inflow bearing occurred in 1 early model. There were no other pump failures, but power interruption occurred when the sheep chewed the cables or head-butted the percutaneous pedestal. At autopsy, there was no thromboembolism or primary thrombus formation in any device. Pump occlusion occurred in 2 sheep with bacterial endocarditis. One electively explanted pump, previously switched off for 5 months, had no thrombus in the device or vascular graft. CONCLUSIONS The Jarvik 2000 Heart is a major advance in blood-pump technology and increases the scope of mechanical circulatory support. Reliability and ease of removal favor its use for bridge to myocyte recovery, as well as for bridge to transplantation or long-term support.

Implant technique for the Jarvik 2000 heart

The Jarvik 2000 Heart is a silent compact axial flow impeller pump which is now undergoing clinical trials for both bridge to transplantation and permanent mechanical circulatory support. The pump is implanted into the apex of the failing left ventricle by left thoracotomy. A vascular graft offloads to the descending thoracic aorta so that only the left pleural cavity is opened. Power supply is through an abdominal drive line or postauricular titanium pedestal according to the treatment strategy.

LVAD Power Delivery: A Percutaneous Approach to Avoid Infection

BACKGROUND Driveline infection limits the event-free survival of patients with a left ventricular assist device. With the evolving prospect of improved left ventricular assist devices in the bridge-to-transplantation or recovery setting, we sought to reduce the risk of driveline complications. METHODS As part of the Oxford Jarvik 2000 research program, we developed a carbon and then titanium pedestal to transmit the electric wires through the skin. In a sheep model, the pedestal was brought out through the skin of the shoulder (n = 10) or the scalp (n = 9) with underlying fixation to the skull. Exit wounds were carefully inspected for healing and infection. Power cable durability tests were performed in 6 additional animals without an implanted pump. RESULTS The cumulative observation period was 1,491 days (mean time, 78 days; range, 14 days to 198 days). There was no difference in observation period between the two groups. Infection (n = 2) and impaired healing (n = 5) occurred in the mobile tissues at the shoulder. Skull-mounted pedestals were free from infection or healing problems. The electric cables were not interrupted by repeated neck flexion (cumulative observation period, 588 days). The carbon pedestal was replaced by a titanium pedestal when the head butting of the sheep fractured the carbon. CONCLUSIONS The combination of rigid fixation and highly vascular scalp skin reduces the risk of percutaneous driveline infection and may solve an important outstanding problem in use of left ventricular assist devices.

The Jarvik 2000 oxford system: Increasing the scope of mechanical circulatory support

METHODS We developed a system for mechanical circulatory support based on the Jarvik 2000 intraventricular axial flow impeller pump (Jarvik Research, Inc., New York, N.Y.) and percutaneous electric power. The adult pump provides flow at a rate up to 10 L/min with an energy requirement of 7 to 10 watts. The device was implanted into the apex of the left ventricle through a left thoracotomy without cardiopulmonary bypass. A Dacron graft conveyed blood to the descending thoracic aorta. In patients, we will use a skull-mounted carbon pedestal to transmit fine electric wires through the scalp skin. Being highly vascular, the scalp skin is resistant to infection. RESULTS We tested 16 adult systems and one pediatric system in 17 adult ewes weighing between 60 and 90 kg. Five died of perioperative complications. Twelve survived between 3 and 198 days (mean 44 days) with a functioning device. None of the sheep could receive adequate anticoagulation with warfarin (INR 1.0 to 1.5). Acute thrombotic occlusion occurred after a 3-hour power loss in one device (46 days) but was cleared with streptokinase. In a second animal with endocarditis, the pump inflow became occluded with vegetations. No other device-related problems or important hemolysis developed despite pump speeds between 10,000 and 18,000 rpm. Renal function remained normal in all animals. Autopsy studies showed no pannus ingrowth at the device inflow despite the restrictive left ventricular cavity size. No sign of thromboembolism could be detected in the brains or kidneys. CONCLUSION Our findings indicate the Jarvik 2000 Oxford System to be a safe and effective circulatory assist device. Potential uses include permanent circulatory support, bridge to transplantation, or bridge to myocardial recovery in acute or chronic left ventricular failure.

Mechanical bridge to recovery in fulminant myocarditis

A patient with acute fulminant lymphocytic myocarditis and cardiogenic shock was successfully treated by mechanical off loading of the left ventricle. A nonpulsatile left-heart bypass was undertaken with an implantable centrifugal blood pump. Careful weaning resulted in device removal on the seventh day. Left and right ventricular function is sustained at 7 months. Widespread application of this method depends on the availability of an inexpensive user friendly blood pump, appropriate weaning protocols and emerging strategies to promote sustainable myocardial recovery.