Hans Granfeldt

HeartMate Left Ventricular Assist Device as Bridge to Heart Transplantation

BACKGROUND Because of the limited supply of donor hearts, prospective recipients continue to die while on the waiting list for heart transplantation. Use of long-term mechanical circulatory support devices as a bridge to transplantation may reduce this mortality. However, with the present state of technology, continued clinical evaluation of the various long-term, mechanical circulatory support devices available is mandatory. METHODS Sixteen patients were bridged with the HeartMate left ventricular assist device (LVAD) to heart transplantation for New York Heart Association functional class IV cardiac failure. Twelve pneumatic and six electric devices were used. The mean cardiac index and the mean pulmonary vascular resistance of the patient cohort were 1.71 x min(-1) x m(-2) and 3.1 Wood units, respectively. RESULTS The mean LVAD support time per transplanted patient was 237 days, with a cumulative LVAD support time of about 7.2 years. Bleeding was the main operative and postoperative complication. Two patients suffered from neurologic complications and there were two major incidents of device malfunction. Twelve patients (75%) now have received a transplant, 3 (19%) are awaiting a transplant, and in 1 patient (6%), the device was explanted after spontaneous left ventricular recovery. Eleven of the 12 patients who received a transplant are alive and doing well. The HeartMate LVAD gave adequate circulatory support over extended periods of time and reversed the vital organ dysfunction. Since the start of the LVAD program, only 1 patient has died on our heart transplantation waiting list, compared to nine deaths in the 2 preceding years. CONCLUSIONS The HeartMate LVAD bridge to heart transplantation can be performed with low post-LVAD implantation and posttransplantation mortality and offers 1- and 2-year posttransplantation actuarial survival rates comparable to those for nonbridged heart transplant recipients.

Coronary artery operation supported by the hemopump: An experimental study on pig

Twelve pigs undergoing coronary artery bypass grafting had the Hemopump to decompress the heart and as circulatory support. The pigs also were given a short-acting beta-blocker, esmolol, to make the heart flaccid. Extracorporeal circulation was not used. During Hemopump support, a bolus dose of 0.5 to 5 mg/kg of esmolol was given before incremental titration steps from 100 to 600 micrograms.kg-1.min-1 over 15 to 20 minutes. The internal thoracic artery was sutured to the distal part of the left anterior descending artery. The Hemopump was withdrawn to the aorta after a weaning period of 20 to 30 minutes. Seven of 12 pigs went through the whole procedure and the Hemopump was weaned off without complications. Five animals died due to right ventricular failure in association with esmolol administration. There was a big interindividual difference in esmolol dose-response curves in the surviving animals. No significant differences in the hemodynamic variables were observed during the experiment. The Hemopump in combination with a short-acting beta-blocker could be an alternate way of performing coronary artery bypass grafting in selected patients.

Coronary artery operation with support of the hemopump cardiac assist system

Five patients with one- or two-vessel disease had one to three bypass grafts using the Hemopump cardiac assist system instead of cardiopulmonary bypass to decompress the heart and as circulatory support. In addition, the short-acting beta-blocker esmolol was given as a bolus and stepwise titrated to make the heart flaccid and facilitate operation. All patients had a 24F Hemopump placed into the left ventricle. The patients were given 7,500 U of heparin. Average time on Hemopump support was 56 minutes. All patients went through the procedure uneventfully. Thirty minutes after pump removal all patients were back to baseline hemodynamic values. None of the patients needed blood transfusion. No postoperative renal impairment was seen. This method has great potential and could avoid the drawbacks associated with cardiopulmonary bypass and cardioplegic arrest. Careful evaluation in randomized studies is the next step.

Cost effectiveness of local collagen-gentamicin as prophylaxis for sternal wound infections in different risk groups

Objectives. In a randomized trial addition of local collagen-gentamicin in the sternal wound reduced the rate of sternal wound infection (SWI) to about 50% compared to intravenous prophylaxis alone. The aim of the present study was to evaluate the economic rationale for its use in every-day clinical practice. This includes the question whether high-risk groups that may have particular benefit should be identified. Design. For each patient with SWI in the trial the costs attributable to the SWI were calculated. Risk factors for SWI were identified and any heterogeneity of the effect of the prophylaxis examined. Results. The mean cost of a SWI was about 14500 Euros. A cost effectiveness analysis showed that the prophylaxis was cost saving. The positive net balance was even higher in risk groups. Assignment to the control group, overweight, diabetes, younger age, mammarian artery use, left ventricular ejection fraction < 35% and longer operation time were independent risk factors for infection. Conclusion. The addition of local collagen-gentamicin to intravenous antibiotic prophylaxis was dominant, i.e. resulted in both lower costs and fewer wound infections.

Experience with the Impella® recovery axial-flow system for acute heart failure at three cardiothoracic centers in Sweden

Objectives. The Impella® recovery axial-flow system is a mechanical assist system for use in acute heart failure. This retrospective study reports the use of the device at three cardiothoracic units in Sweden. Design. Fifty patients (35 men, mean age 55.8 years, range 26 to 84 years) underwent implantation of 26 Impella®LP 2.5/5.0 (support-time 0.1 to 14 days), 16 Impella®LD (support-time 1 to 7 days) and 8 Impella®RD (support-time 0.1 to 8 days) between 2003 and 2007. Implantation was performed because of postcardiotomy heart failure (surgical group, n=33) or for various states of heart failure in cardiological patients (non-surgical group, n=17). The intention for the treatments was mainly to use the pump as a ”bridge-to-recovery”. Results. Early mortality in the surgical and non-surgical groups was 45% and 23%, respectively. Complications included infection, 36% and right ventricular failure, 28%. Cardiac output and cardiac power output postoperatively were significantly higher among survivors than non-survivors. Conclusions. The Impella® recovery axial-flow system facilitates treatment in acute heart failure. Early intervention in patients with acute heart failure and optimized hemodynamics in the post-implantation period seem to be of importance for long-term survival. Insufficient early response to therapy should urge to consider further treatment options.

Postoperative management of patients with hemopump support after coronary artery bypass grafting

BACKGROUND In this study, we describe postoperative monitoring, pharmacologic therapy, and hemodynamic responses in patients receiving Hemopump support after postcardiotomy heart failure. METHODS The Hemopump was used in 24 patients with severe left ventricular dysfunction after coronary artery bypass grafting. RESULTS Fourteen patients (58%) were weaned from the Hemopump. Low to moderate doses of a combination of catecholamines, phosphodiesterase inhibitors, vasodilators, and vasoconstrictors were required to optimize Hemopump function and left ventricular unloading. Mean arterial blood pressure, mixed venous oxygen saturation, and urinary output were the most important therapy guidelines. CONCLUSIONS Together with our clinical protocol, the Hemopump effectively unloaded the failing ventricle while maintaining vital-organ perfusion. Doses of vasoactive drugs could be kept low. This approach to treatment provides good conditions for recovery of the stunned myocardium.

Initial tests with a new cardiac assist device

Before, during, and after cardiac intervention, there is occasionally a need for circulatory support because of hemodynamic deterioration. For this purpose, a new minimally invasive cardiac assist device has been developed, and an early prototype has been studied in a bench test and in three pigs. The pump is a catheter system with a distal motor driven propeller (0-15,000 rpm) surrounded by a cage. The catheter was first tested in a tube in a water bath, where efficiency with respect to pressure generation and flow properties was measured. In the pig experiments, the pump was placed in the descending part of the aorta via a graft, and hemodynamic effects were recorded with three different propellers. The bench tests showed a velocity dependent pressure generation in the tube to the second power of the rpm, and 30 cm of water (> 22 mm Hg) could easily be achieved with all propellers. A pressure dependent flow in the tube was observed, with maximum flows of 20 L at 12,000 rpm and 27 L at 15,000 rpm. In the animal experiments, there was a velocity dependent mean pressure difference across the propeller, with up to 48 mm of mercury for the biggest propeller. An increase in cardiac output in all of the pigs was observed as well as a drop in pressure in the proximal part of the aorta. This study demonstrates the efficiency of this new device in vitro and in vivo. Hemodynamic changes are pronounced and are related to the speed and size of the propeller.

Acoustic Analysis of a Mechanical Circulatory Support

Mechanical circulatory support technology is continually improving. However, adverse complications do occur with devastating consequences, for example, pump thrombosis that may develop in several parts of the pump system. The aim of this study was to design an experimental clot/thrombosis model to register and analyze acoustic signals from the left ventricular assist device (LVAD) HeartMate II (HMII) (Thoratec Corporation, Inc., Pleasanton, CA, USA) and detect changes in sound signals correlating to clots in the inflow, outflow, and pump housing. Using modern telecom techniques, it was possible to register and analyze the HMII pump-specific acoustic fingerprint in an experimental model of LVAD support using a mock loop. Increase in pump speed significantly (P < 0.005) changed the acoustic fingerprint at certain frequency (0–23 000 Hz) intervals (regions: R1–3 and peaks: P1,3–4). When the ball valves connected to the tubing were narrowed sequentially by ∼50% of the inner diameter (to mimic clot in the out- and inflow tubing), the frequency spectrum changed significantly (P < 0.005) in P1 and P2 and R1 when the outflow tubing was narrowed. This change was not seen to the same extent when the lumen of the ball valve connected to the inflow tube was narrowed by ∼50%. More significant (P < 0.005) acoustic changes were detected in P1 and P2 and R1 and R3, with the largest dB figs. in the lower frequency ranges in R1 and P2, when artificial clots and blood clots passed through the pump system. At higher frequencies, a significant change in dB figs. in R3 and P4 was detected when clots passed through the pump system. Acoustic monitoring of pump sounds may become a valuable tool in LVAD surveillance.

Risk factor analysis of Swedish left ventricular assist device (LVAD) patients

BACKGROUND The use of left ventricular assist devices (LVADs) is established as a bridge to heart transplantation. METHODS All Swedish patients on the waiting list for heart transplantation, treated with LVAD since 1993 were retrospectively collected into a database and analyzed in regards to risk factors for mortality and morbidity. RESULTS Fifty-nine patients (46 men) with a median age of 49 years (range, 14 to 69 years), Higgins score median of 9 (range, 3 to 15), EuroScore median of 10 (range, 5 to 17) were investigated. Dominating diagnoses were dilated cardiomyopathy in 61% (n = 36) and ischemic cardiomyopathy in 18.6% (n = 11). The patients were supported with LVAD for a median time of 99.5 days (range, 1 to 873 days). Forty-five (76%) patients received transplants, and 3 (5.1%) patients were weaned from the device. Eleven patients (18.6%) died during LVAD treatment. Risk factor analysis for mortality before heart transplantation showed significance for a high total amount of autologous blood transfusions (p < 0.001), days on mechanical ventilation postoperatively (p < 0.001), prolonged postoperative intensive care unit stay (p = 0.007), and high central venous pressure 24 hours postoperatively and at the final measurement (p = 0.03 and 0.01, respectively). Mortality with LVAD treatment was 18.6% (n = 11). High C-reactive protein (p = 0.001), low mean arterial pressure (p = 0.03), and high cardiac index (p = 0.03) preoperatively were risk factors for development of right ventricular failure during LVAD treatment. CONCLUSIONS The Swedish experience with LVAD as a bridge to heart transplantation was retrospectively collected into a database. This included data from transplant and nontransplant centers. Figures of mortality and morbidity in the database were comparable to international experience. Specific risk factors were difficult to define retrospectively as a result of different protocols for follow-up among participating centers.

Hemopump treatment in patients with postcardiotomy heart failure

BACKGROUND This study examined the use of the Hemopump to treat low cardiac output syndrome after cardiopulmonary bypass. METHODS We used the Hemopump temporary cardiac assist system in 29 patients with severe left ventricular dysfunction after open heart operations from September 1991 to November 1994. RESULTS Five patients were excluded from the study due to initial patient/device-related problems. Ten patients died in the operating room or early during the stay in the intensive care unit due to progressive biventricular failure. Fourteen patients (58.3%) were weaned from the device, and all of them were later discharged. In a subgroup of patients (54%) in whom we had a more aggressive approach for early insertion of the pump, the survival rate was 85%. Preoperative Higging risk score was significantly related to survival. CONCLUSIONS The Hemopump can effectively unload a failing left ventricle with preservation of multiorgan perfusion. A minor decrease in kidney function was observed in most patients, but none of the surviving patients needed hemodialysis. One patient required a short period of peritoneal dialysis to get rid of fluid overload. Hemolysis or platelet dysfunction was not a clinical problem.