Implantation of CardioWest total artificial heart for irreversible acute myocardial infarction shock.

Patients who develop cardiogenic shock after acute myocardial infarction have a very high mortality rate despite early reperfusion therapy. Hemodynamic stabilization can often only be achieved by implanting a mechanical circulatory support system. When, in cases representing expansive myocardial impairment without any chance of recovery, pharmacological therapy and the use of percutaneous assist devices have failed, the implantation of a total artificial heart is indicated. We report our first experiences with this extensive and innovative method of managing irreversible cardiogenic shock patients. The CardioWest total artificial heart was implanted in 5 patients (male; mean age, 50 years). All patients were in irreversible cardiogenic shock despite maximum dosages of catecholamines, an intra-aortic balloon pump and/or a femoro-femoral bypass. In all patients early reperfusion therapy was performed. After implantation of the Cardio West system, all dysfunctional organ systems rapidly recovered in all patients. Four of 5 patients underwent successful heart transplantation after a mean support time of 156 days. One patient died because of enterocolic necroses caused by an embolic event after termination of dicumarol therapy. In summary, our first experiences justify this extensive management in young patients who would otherwise have died within a few hours.

IgG classification of anti-PF4/heparin antibodies to identify patients with heparin-induced thrombocytopenia during mechanical circulatory support.

Commercial immunoassays frequently detect anti-PF4/heparin antibodies during mechanical circulatory support (MCS), but only a small minority of patients develops heparin-induced thrombocytopenia (HIT). Whereas platelet functional tests can distinguish between platelet-activating and non-platelet-activating antibodies, commercial PF4-dependent immunoassays do not. Between 2003 and 2004, 113 patients were placed on MCS. Blood samples were obtained on postimplant day 5-7 for analyses by antibody assays and the functional heparin-induced platelet activation (HIPA) assay. Three distinct groups of patient sera were identified: platelet-activating anti-PF4/heparin antibodies (n = 10), non-platelet-activating anti-PF4/heparin antibodies (n = 53), and anti-PF4/heparin antibody negative (n = 50). Patients with platelet-activating antibodies had the highest risk for thromboembolic events (P < 0.005), whereas those with non-platelet-activating antibodies did not differ from antibody negative patients (P = 0.369). The enzyme-immunoassay and column agglutination assays, which cover all immunoglobulin classes, demonstrated adequate sensitivity and negative predictive value; yet, both lacked specificity with respect to the platelet-activating antibodies. If all antibody positive patients were further classified by an IgG-specific anti-PF4/heparin enzyme-immuno assay, specificity for platelet-activating antibodies increased. Whereas IgG-specific optical density (OD) values below 1.0 were likely for non-platelet-activating anti-PF4/heparin antibodies, higher values were progressively predictive for pathogenic platelet activation. The probability of the development of clinical HIT also increased steeply. In conclusion, platelet-activating anti-PF4/heparin antibodies are relatively common (about 9%) in patients on MCS and are associated with significantly higher thrombotic event rates. Low IgG-specific OD values (< 1.0) in the enzyme-immunoassay indicate low likelihood for the presence of platelet-activating antibodies. These results justify further validation so that anticoagulation during MCS becomes safer and adequate.

Papillary fibroelastoma of the ascending aorta presenting with cardiogenic shock.

We describe an uncommon case of a 58-year-old woman who presented with cardiogenic shock. The echocardiography examination revealed a papillary fibroadenoma located in the ascending aorta which was subsequently surgically treated.

Mechanical circulatory support: reality and dreams experience of a single center.

Because of the increasing number of patients waiting for heart transplantation and the decreasing number of donor organs, mechanical circulatory support has become a generally accepted therapeutic option. Several high-tech devices developed in the last 15 years differ in terms of location, kind of support, and driving units. They are suitable for different patients and their therapeutics objectives. Based on 13 years of experience, we developed a specific protocol for selection and management of patients and devices. Six hundred two patients have received mechanical circulatory support (MCS) in our institution since 1987. The indication spectrum includes cardiogenic shock for various reasons: acute myocarditis, right heart failure, acute rejection and postcardiotomy heart failure, alternative to transplantation, and bridge to recovery. Eight different systems are in use at our center. The extracorporeal devices, the Biomedicus centrifugal pump (n = 169) and the Abiomed BVS 5000 (n = 92) are used for short-term support. The Thoratec VAD (n = 179), and Medos HIA-VAD (n = 10) located in paracorporeal position preferably used for midterm support. Novacor LVAS (n= 96), and HeartMate (n = 58) are partially implantable systems used for long-term ventricular assistance in patients who did not require biventricular support. The advantage of the implantable devices is the option of discharging patients under support if they fulfill special criteria before being discharged to home. Eighty-five LVAD patients were discharged home with support, Novacor (n = 52), HeartMate (n = 27), ThoratecTLC-II (n = 8), Lionheart (n = 3) fulfill our criteria for being discharged home while on support. Careful postoperative patient management does not exclude a variety of complications. Bleeding: occurred in 22-35% of patients, right heart failure in 15-26%, neurologic disorder in 7-28%, infection in 7-30%, and liver failure in 11-20%. Complications varied with different devices, and the patients' preoperative conditions. Eighty-five patients fulfilled the criteria of our out of hospital program (OOH) and were discharged from hospital for a mean period of 184 days. Readmission was necessary for complications caused by thromboembolism and infection. This report describes our patient device selection criteria as a bridge to transplant setting.

[Implantation of CardioWest total artificial heart in irreversible acute myocardial infarction shock-new hope for patients with infaust prognosis]. / Einsatz des CardioWest-Kunstherzens beim irreversiblen kardiogenen Schock nach Myokardinfarkt. Eine Hoffnung für Patienten mit infauster Prognose.

Patients in whom cardiogenic shock develops after acute myocardial infarction have a very high death rate despite early reperfusion therapy. Often hemodynamic stabilization can be achieved only by implantation of a mechanical circulatory support system. When pharmacological therapy and onset of percutaneous assist devices fails in cases representing expansive myocardial impairment without any chance of recovery, the indication for implanting a total artificial heart is given. We report on our first experiences with this extensive and innovative management of irreversible cardiogenic shock patients. In five patients (male, mean age 50 years) the CardioWest total artificial heart was implanted. All patients were in irreversible cardiogenic shock despite maximal dosages of catecholamines, intraaortic balloon pump and/or femorofemoral bypass. In all patients early reperfusion therapy was performed. After implantation of the CardioWest system, rapid recovery of all dysfunctional organ systems occurred in all patients. Four of five patients underwent successful heart transplantation after a mean support time of 156 days. One patient died because of enterocolic necroses caused by embolic event after termination of dicumarol therapy. In summary, first experiences justify this extensive management in these young patients who otherwise would have died within a few hours.

Recovery of organ dysfunction during bridging to heart transplantation in children and adolescents.

The beneficial effects of ventricular assist devices on organ dysfunction during bridging to heart transplantation have been widely reported in the adult population. In contrast, the use of ventricular assist devices used as bridge-to-transplant in children is limited. To evaluate organ recovery during ventricular support in pediatric transplant candidate, respiratory, renal and hepatic function were reviewed retrospectively. The Thoratec device (stroke volume 65 ml) and the HIA-Medos-system (stroke volume 25/10 ml) were used as bridge-to transplant in 11 children and adolescents who were in low-output-syndrome despite maximal pharmacological support. Prior to implantation five patients were mechanically ventilated, six patients underwent cardiopulmonary resuscitation, eight patients had anuria (one treated by hemofiltration), three patients had liver dysfunction and four patients had signs of severe infection. At the time of implantation one patient was supported by the intraaortic balloon pump and one by the femorofemoral bypass for rapid hemodynamic stabilization. Eight patients were treated using the Thoratec device (one of these by Nova cor on the left side), three by the HIA-Medos system. The support time ranged between seven and 140 days. Seven patients could be extubated within three days. Renal function recovered in all pts. Liver enzymes decreased in all pts without reaching normal values. Bilirubin values also decreased in survivors but increased to 9.3 mg/dL in non-survivors. At least seven patients underwent successful heart transplantation, three patients died because of multiorgan failure after extended transfusion and one patient because of technical failure. In our experience the hemodynamic situation was sufficient in all bridging to transplant candidates. In all patients who underwent successful transplantation, transplantability was associated with rapid organ recovery within seven days after initiating mechanical assistance. Extended blood tranfusions, combined failure of three organs and increasing bilirubin values during support seem to be predictors of poor outcome.

The time course of natriuretic hormones as plasma markers of myocardial recovery in heart transplant candidates during ventricular assist device support reveals differences among device types.

BACKGROUND: The natriuretic hormones ANP and BNP are expressed differently in the myocardium. Both hormones have compensatory diuretic activity during heart failure. Mechanical stretch of the myocardial walls induces the expression of these hormones. In failing human myocardium, both ANP and BNP are transcribed in the ventricular myocardium in high amounts. We measured the plasma concentrations of ANP and BNP in patients supported by various ventricular assist devices (VADs) at various times. We analyzed the time courses of ANP and BNP to determine (1) the time scale of their down-regulation as a marker of putative myocardial recovery, (2) their steady-state levels under VAD support and (3) differences caused by various VAD devices. METHODS: We analyzed ANP and BNP using commercially available radioimmune assays. We analyzed the time courses of patients supported by Thoratec (THO) LVAD (n = 8), TCI Heartmate (TCI) (n = 6), Novacor (NOV) (n = 7), and Lionheart (LIO) (n = 3). RESULTS: Patients supported with NOV and some patients with TCI showed down-regulation of BNP to a steady-state level at 30 to 50 days, following a single exponential decay. In contrast, patients supported by THO or LIO did not reveal a determined time course of the natriuretic hormones. Only a few patients reached normal plasma values during VAD support. CONCLUSION: The time courses of ANP and BNP differ among VAD types because of construction and/or driving mode, which might be important when considering patients for weaning from VAD without heart transplant.

Outcome of heart transplantation in patients previously infected with hepatitis C virus.

The lack of knowledge about the course of hepatitis C virus infection (HCV) before heart transplantation (HTx) prompted us to describe our experience with 4 such patients who presented with positive HCV serology before surgery. Two experienced non-liver related deaths at 3.5 and 5 years after HTx, and none of the patients developed signs of hepatic insufficiency during the follow-up (mean 3.8 years). Tests for HCV antibodies were frequently negative, whereas viral RNA was detected in 81% of the measurements, showing that virus detection techniques seem to be more sensitive than serology techniques in detecting HCV infection in this group of patients. Although immunosuppression promotes active HCV replication, it does not seem to change the chronic features of HCV infection during the first years in patients with good liver function.

Device and patient management in a bridge-to-transplant setting.

BACKGROUND: A variety of sophisticated devices have been developed for mechanical circulatory support in patients bridged to cardiac transplantation. Based on 13 years' experience, we have developed specific protocols for patient selection and management for different devices. METHODS: The principal systems applied in the bridge-to-transplant cohort are the Thoratec ventricular assist device (n = 144, mean duration of support 53 +/- 57 days), the Novacor left ventricular assist system (LVAS) (n = 85, mean duration of support 154 +/- 15 days), and the HeartMate LVAS (n = 54, mean duration of support 143 +/- 142 days). The Thoratec device is used for biventricular assistance or if the duration of support is expected to be less than 6 months. For long-term support, either the Novacor or HeartMate LVAS are preferred. RESULTS: Despite careful postoperative patient management, this group of patients is prone to a variety of complications. Bleeding occurred in 22% to 35%, right heart failure in 15% to 26%, neurologic disorders in 7% to 28%, infection in 7% to 30%, and liver failure in 11% to 20% of patients. Complications varied with the device applied and the patient's preoperative condition. A total of 73 patients were discharged from hospital for a mean period of 184 days; this cumulative experience amounted to 37.5 patient-years. CONCLUSIONS: The Novacor and the HeartMate systems offer the additional possibility of discharging patients during support if they fulfill certain criteria. The main reasons for rehospitalization were thromboembolic and infectious complications.

Midterm follow-up of patients discharged from hospital under left ventricular assistance.

BACKGROUND: Against the background of increasing demand for long-term mechanical circulatory support, discharging patients to their homes while on assist devices becomes more and more important. This report describes the midterm follow-up of 66 patients who were allowed to leave the hospital under left ventricular assist device (LVAD) support with Novacor or HeartMate systems. Between May 1994 and January 2000, 66 patients (9 women, 57 men, between 15 and 68 years old) under LVAD support fulfilled our criteria for being discharged home on the device. Intent to treat comprised bridging to transplantation in 59 patients, bridging to recovery in 5 patients, and alternative to transplantation in 2 patients. Forty-four patients received support with Novacor, 18 patients with the VE HeartMate, 2 patients with centrifugal pumps and Novacor, and 1 patient each with Novacor and Thoratec/Medos HIA-VAD. The mean out-of-hospital (OOH) follow-up period was 162 +/- 187 days, with a cumulative OOH experience of 30 patient years. Twenty-nine patients were not readmitted, and 37 patients were readmitted 54 times (23 patients were readmitted once, 11 patients twice, and 3 patients 3 times). The primary reasons for readmission included neurologic disorders and infection complications. At 229 days, 50% of all patients were free from readmission. The readmission rate was 1.8 patient/year. Sixteen patients died while on LVAD support (24%). Our midterm follow-up results show the safety and efficacy of this therapeutic option. Acceptable hospital readmission rates strongly support the future use of this technology as an alternative to transplantation in managing end-stage heart failure patients.

Predictors of survival in patients bridged to transplantation with the thoratec VAD device: a single-center retrospective study on more than 100 patients.

BACKGROUND: Careful patient selection markedly influences the outcome of patients who undergo mechanical circulatory support. Therefore, we tried to evaluate predictors of survival after implantation of the Thoratec ventricular assist device (VAD). METHODS: Between October 1992 and January 2000, 104 patients (86 men, 18 women, aged 11 to 69 years) received the Thoratec VAD as a bridge to transplant. A total of 51 patients required left ventricular support (LVAD), 50 patients required biventricular support (BVAD), and 3 patients required total artificial heart implantation. We performed univariate analysis of 25 parameters with regard to their effect on survival and then applied a multivariate analysis to evaluate those factors that turned out to be marginally significant. We performed all analysis for the total collective as well as for the LVAD and BVAD sub-group. RESULTS: The BVAD patients tended to have worse outcomes than did LVAD patients. We found no significant predictors of survival in either sub-group. In the total collective, however, we found the following pre-implant conditions were independent risk factors for survival after VAD implantation: patient age > 60 years (odds ratio [OR] 3.87, confidence interval [CI] 1.39 to 10.76), pre-implant ventilation (OR, 6.76; CI 2.42 to 18.84), and increased pre-implant total bilirubin (OR, 1.42; CL, 1.19 to 1.69). CONCLUSIONS: Transplant candidates on inotropic support should be considered for bridging to transplant as soon as bilirubin values start to increase or before respiratory function deteriorates and ventilation becomes necessary. In elderly patients, careful patient selection, particularly considering potential risk factors, might favorably affect their outcomes.

Morbidity and outcome after mechanical ventricular support using Thoratec, Novacor, and HeartMate for bridging to heart transplantation.

Between September 1989 and June 1999, 228 patients were supported with a ventricular assist device as a bridge to heart transplantation. In this study, the results of implantation were evaluated in patients supported with one type of device, including 85 supported with a Thoratec, 61 with a Novacor, and 37 with a HeartMate. The mean support time was 49, 148, and 124 days, respectively. Successful transplantation and weaning rates were 64. 7% with Thoratec, 59.0% with Novacor, and 62.0% with HeartMate. Cerebral embolism and drive-line and pocket infection were major causes of postoperative morbidity and mortality. We recommended that a Thoratec system be employed as a bridge to heart transplantation for patients with biventricular heart failure, and that a Novacor or HeartMate system be implanted in patients requiring a long-term circulatory support.

Pre-existing elevated pulmonary vascular resistance: long-term hemodynamic follow-up and outcome of recipients after orthotopic heart transplantation.

BACKGROUND: Elevation of pulmonary vascular resistance (PVR) has been considered to predict a bad outcome after orthotopic heart transplantation (HTx). A transpulmonary gradient (TG) > or =15 mmHg and PVR > or =5 wood (w) are correlated with a three-fold increase in 2-days as well as 30-days and 6-, 12-month mortality. METHODS: We performed a retrospective analysis of 400 consecutive transplanted patients (pts) on hemodynamic data over a time period of 3.5 years. In 83 pts (23%) preoperative PVR was > or =5 w and TG >15 mmHg. Vasodilator studies were performed in this group of pts in order to evaluate pulmonary vasoreactivity or hemodynamic improvement. RESULTS: Hemodynamic follow-up post-transplantation showed a significant (p<0.001) decrease in mean TG to 8.8 mmHg within the first, 7.7 after the fifth year as well as decrease in PVR from 5.5 to 1.6, within the first and fifth year post-transplantation. Compared to the control group (n=286) (re-transplants n=6 and pediatric pts n=25 excluded) pts with TG <15 mmHg and/or PVR <5 w, transplanted within the same period, 30-day mortality and cumulative survival after 1 and 5 years do not show any significant difference with a mortality of 3%, 22% and 33% (p<0.05). Subgroup analysis for pts with endstage of ischemic versus dilatative cardiomyopathy has not shown any significant difference in mortality. CONCLUSIONS: In a retrospective analysis of 400 pts elevated PVR does not predict a bad outcome after orthotopic heart transplantation in early and late mortality.

Novacor left ventricular assist system versus Heartmate vented electric left ventricular assist system as a long-term mechanical circulatory support device in bridging patients: a prospective study.

OBJECTIVE: Long-term mechanical circulatory support as a bridge-to-transplantation procedure and bridge to recovery is of increasing importance. The implantable left ventricular assist devices, Novacor N100 left ventricular assist system (Baxter Healthcare Corporation, Berkeley, Calif) and TCI HeartMate vented electric left ventricular assist system (Thermo Cardiosystems Inc, Woburn, Mass), have proved to be efficient devices in bridge-to-transplantation settings and for prolonged support. The two systems were compared with regard to reliability and morbidity. METHODS: Between October 1996 and March 1998, a prospective, single-center study was done that included 40 patients, 20 of whom were treated with the Novacor system and 20 of whom were treated with the HeartMate device. The diseases were mainly dilated cardiomyopathy (13/9) and ischemic cardiomyopathy (6/10). There were no statistically significant differences between the two groups regarding age, sex, preoperative clinical blood chemistry values, hemodynamic data, or risk factors. RESULTS: There were no statistically significant differences between the two groups with regard to postoperative hemodynamics, organ recovery, out-of-hospital support, and survival to heart transplantation. Mean duration of support was 235.3 +/- 210 days for the Novacor group and 174.6 +/- 175 days for the HeartMate group and mean out-of-hospital support was 241 +/- 179 days and 166 +/- 152 days for the two groups, respectively. Neurologic complications occurred significantly more often among the Novacor group, whereas the HeartMate group had a higher prevalence of infections and technical problems, which was statistically significant. Survival to transplantation was 65% for the Novacor group and 60% for the HeartMate group. CONCLUSIONS: Most patients had organ recovery with left ventricular assist system support, and a considerable number of patients in both groups underwent transplantation. However, both devices need revision to address the current problems, that is, thromboembolism for the Novacor device and infection and reliability for the HeartMate device.

Single-center experience with the thoratec ventricular assist device.

OBJECTIVE: The Thoratec ventricular assist device (Thoratec Laboratories, Pleasanton, Calif) is widely accepted for univentricular and biventricular support in patients with various indications. The aim of this study is to describe our experience with implantation of the Thoratec ventricular assist device in more than 100 patients. METHODS: From March 1992 to June 1998, 114 patients (98 men and 16 women; mean age, 47.9 years) received the Thoratec ventricular assist device for a mean duration of 44.9 days. The patients were divided into 3 groups. Group 1 included 84 patients in whom the system was applied as a bridge-to-transplant procedure. Group 2 included 17 patients with postcardiotomy cardiogenic shock, and group 3 included 13 patients with cardiogenic shock of other causes. RESULTS: Sixty-eight percent of patients in group 1 survived to transplantation with a posttransplant survival of 88%. The only independent risk factor affecting survival was age more than 60 years. Survivals in groups 2 and 3 were 47% and 31%, respectively. Main complications in all groups were bleeding, multiple organ failure, liver failure, sepsis, and neurologic disorders. CONCLUSIONS: The Thoratec ventricular assist device has proved to be a reliable device for bridge to transplantation and postcardiotomy support. Further studies are required on patient selection and on patient and device management to reduce the incidence of complications in these patient populations.

Influence of different assist devices on survival after orthotopic heart transplantation.

BACKGROUND: In 1995, a risk factor of 1.88 was indicated for one-year mortality in connection with bridging to heart transplantation. Both one-year and three-year survival rates in patients bridged to transplantation were less than 80%. METHODS: From 3/89 to 12/98, 903 orthotopic heart transplantations were performed at our center in 888 recipients. Bridging was necessary in 142 patients. RESULTS: The one-year survival rate was 76% in pts without VAD, 86% in pts bridged with VAD and 66% in pts with VAD due to postcardiotomy syndrome. The three-year survival rates were 73%, 80% and 55% respectively. CONCLUSIONS: Early and late results in patients bridged to transplantation remarkably improved over 1995. One-year and long-term survival rates are significantly lower when assist devices are used in patients with postcardiotomy syndrome. Despite a high incidence of assist-related complications, electively bridged patients showed significantly better early and long-term results than the control group.