Total Artificial Heart Implantation Blood Pressure Management as Resolving Treatment for Massive Hemolysis following Total Artificial Heart Implantation.

The SynCardia Total Artificial Heart (TAH) has been used for patients with biventricular failure, who cannot be managed with implantation of a left ventricular (LV) assist device. Following TAH implantation, our patient developed severe hemolysis, which could only be managed successfully by aggressive blood pressure control [Ohashi 2003; Nakata 1998].

Successful treatment of peripartum cardiomyopathy with extracorporeal membrane oxygenation.

A 24-year-old female developed heart failure within four months of delivering her first child. Echocardiogram revealed a moderately dilated left ventricle with severely reduced systolic function. She continued to decompensate, requiring intubation and inotropic support. When the use of an intra-aortic balloon pump failed to stabilize the patient, the decision was made to place her on ECMO. The circuit consisted of a Quadrox D membrane oxygenator and a CentriMag centrifugal pump. After 11 days of support, the patient met the weaning criteria and was successfully removed from ECMO. She was discharged one month after her admission. The new technology available allows for ECMO to be considered as an earlier option for the treatment and management of these patients as a bridge to recovery.

Alternatives to heart transplantation. Symposium of the "Treatment of End-stage Heart and Lung Failure" working group on October 22, 2005 in Munich.

Heart transplantation is currently the treatment of first choice in patients with end-stage refractory heart failure. But already the demand for donor organs cannot be met, and patients face long waiting times for transplantation. In the future waiting times will become even longer as life expectancy increases and the number of heart-failure patients requiring transplantation grows. Consequently, in view of the poor prognosis of the disease in its advanced stages, alternatives to heart transplantation are increasingly gaining importance. In recent years new innovative treatment methods and techniques have been developed which have already proved clinically successful in patients with end-stage heart failure, especially as bridging measures. Some of these techniques appear suitable for long-term use and could therefore serve as an alternative to heart transplantation in some patients. Interesting new avenues of research may even lead to cardiac cell replacement therapies in the future. These approaches are currently undergoing initial clinical trials. This report presents surgical and cardiologic treatments for end-stage heart failure that have already been clinically investigated as well as techniques that are still in the preclinical stage and discusses their potential as alternatives to heart transplantation.

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.

A risk score to predict 30-day mortality in patients with intra-aortic balloon pump implantation.

BACKGROUND: Several risk factors for early mortality after intra-aortic balloon pump (IABP) implantation have been described. METHODS: We performed a retrospective analysis in 120 patients receiving peri- or postoperative IABP support. Univariate and multivariate analyses were carried out to assess variables potentially influencing 30-day mortality in order to develop a risk score for the prognosis of survival and for the decision on optimal patient-specific treatment. RESULTS: The 4 parameters (mean arterial pressure, adrenaline dose, central venous pressure, and blood lactate concentrations) at 6 hours of IABP use were independently related to 30-day mortality. They were used to develop a risk score (0 - 4 points). With this score, patients who scored 3 or 4 points had no probability of surviving, whereas patients with a score of zero had a probability of 84.4 %. A prospectively screened cohort of 145 patients confirmed the reliability of our risk score. CONCLUSIONS: Our data demonstrate that a score can predict 30-day mortality in patients with IABP implantation. Such a score can be useful to find out whether or not ECMO/VAD implantation is necessary.

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.

Heart transplantation in children after mechanical circulatory support: comparison of heart transplantation with ventricular assist devices and elective heart transplantation.

Heart transplantation (HTx) is an ultimate treatment for children with end-stage heart failure or inoperable congenital heart disease. The supply of hearts is inadequate; therefore, different mechanical support systems must be used as bridge to HTx in pediatric patients with postoperative low output. The use of ventricular assist devices (VADs) as bridge to HTx in children is limited because of size differences. The purpose of this study was to evaluate the overall long-term outcome of pediatric circulatory support before pediatric HTx. From 1989 through 2004, 91 pediatric patients underwent isolated HTx. Seven of them required mechanical support before transplantation. We reviewed retrospectively the course of 91 children (mean age 14.7 years) who underwent HTx. Group A consisted of elective HTx patients who were treated as outpatients before HTx, whereas group B was the VAD-HTx bridging group (n=7; mean age 12.31 +/- 2.8 years). Mean duration of VAD support was 108 +/- 98 days (minimum 1 day, maximum 258 days). Overall survival rate after HTx was 80% at 1 year without significant differences between groups. Five of seven patients survived and could be discharged after successful HTx, for a survival rate of 77%. The mean follow-up period was 16.76 +/- 10.6 months. No differences in posttransplantation long-term survival and rejection episodes occurred between patients transplanted with or without VAD. VAD therapy can keep pediatric patients with end-stage heart failure alive until successful HTx, and bridge to HTx is a safe procedure in pediatric patients. After HTx, survival rates of these children are similar to those of patients awaiting elective HTx.

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.

First use of the Molecular Adsorbent Recirculating System technique on patients with hypoxic liver failure after cardiogenic shock.

The Molecular Adsorbent Recirculating System (MARS) has been proven to prolong survival in patients with hepatorenal syndrome. MARS is a modified dialysis that uses an albumin containing dialysate, which is recirculated and perfused online through charcoal and anion exchanger columns. It allows the selective removal of albumin bound substances. Despite advances in medical therapy and technology, the prognosis of patients with cardiogenic shock remains poor. Mortality rates are as high as 80%, often because of persistent multiple organ failure. To determine whether patients with hypoxic liver failure after cardiogenic shock after cardiac surgery might benefit from MARS, we performed a prospective, randomized, controlled, single center study. The primary objective was to prove that MARS improves survival. This article is a report on the interim analysis of the first 27 patients included between August 2000 and December 2001; 14 patients were in the MARS group, and 13 patients were in the non-MARS group. All had bilirubin levels greater than 8 mg/ml. Both groups had a similar risk profile. The MARS group received MARS for 3 consecutive days-if bilirubin was still greater than 6 mg/dl afterward, MARS was continued. The non-MARS group received conventional therapy. We had seven survivors in the MARS group (50%) compared with four (32%; p = ns) in the non-MARS group. We conclude that despite the limited number of patients included in this analysis, MARS can be recommended for patients with acute, hypoxic liver failure because it might prolong survival. Further studies in similar patient cohorts are needed to verify our results.

Intermittent aortic cross-clamping for isolated CABG can save lives and money: experience with 15307 patients.

BACKGROUND: The ideal myocardial protection during isolated CABG is still a matter of debate. Cardioplegia versus intermittent aortic cross-clamping (IACC) are the main opponents; the following article shows that IACC can be safe, efficient and might be cheaper than cardioplegia. METHODS: Demographics and co-morbidities of 15307 CABG only patients consecutively operated on between January 1993 and October 2001 in the Heart Center in Bad Oeynhausen were assessed by the German Quality Assurance data set and risk-stratified using the EuroSCORE. Outcome (30-day or in-hospital mortality) was compared to the expected EuroSCORE estimation. RESULTS: Expected mortality was 3.25 %, observed mortality was 1.3 %, being significantly lower in the low, medium as well as high risk patients subgroup. Complication rates increased steadily with expected mortality rates. Stroke and myocardial infarction rates for patients with peripheral vessel disease were not higher than in comparable studies. More than 1000000 EUR were saved by lower cardioplegia bills. CONCLUSION: Myocardial protection with intermittent aortic cross-clamping for isolated CABG can be safe, effective, and economically advantageous when compared to cardioplegic solutions.

[Mechanical circulatory support: 15 years of experience in the Heart Center North Rhine-Westphalia]. / Mechanische Kreislaufunterstützung--15 Jahre Erfahrung im Herzzentrum Nordrhein-Westfalen.

OBJECTIVES: Against the background of an increasing number of patients suffering from severe congestive heart failure, mechanical circulatory support becomes more and more important. The indications for this therapeutic option ranges from bridging to cardiac transplantation, the application of the most recent systems as an alternative to transplantation, as well as in cardiogenic shock following open-heart surgery, acute myocardial infarction of fulminant myocarditis. PATIENTS AND METHODS: Between September 1987 and November 2002, 670 implantations of 11 different mechanical circulatory support systems were performed in 607 patients (125 women, 482 men, age 1 month - 82 years). 255 patients received the device as a bridge to recovery (BTR) of their native organ, 276 patients as a bridge to cardiac transplantation (BTT), 49 patients as an emergency measure in life-threatening cardiogenic shock (bridge-to-bridge, BTB), and 27 patients as an alternative to transplantation (ATT). RESULTS: 38% of the BTR group, 56% of the BTT group, 34% of the BTB group and 27% of the ATT group underwent successful cardiac transplantation or could be discharged from hospital. Infections and thromboembolic events were the most frequent complications but decreased with increasing experience and sophistication of devices. Some systems offer the possibility of discharging patients home while on the device. In our cohort, 90 patients left the hospital on support for a mean duration of 204 days. Readmission rate after 200 days was 50% and was system-related in less than 6%. CONCLUSIONS: In spite of a still considerable morbidity associated with the employment of mechanical circulatory support, the results are encouraging and justify the high economic burden.

[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.

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.

Differential indication for mechanical circulatory support following heart transplantation.

PURPOSE: We describe our experience with ventricular assist devices (VAD) in patients with cardiogenic shock refractory to pharmacological therapy and support using intraaortic balloon pump after cardiac transplantation. PATIENTS: Between July 1987 and August 1997, 848 patients underwent cardiac transplantation in our hospital. INTERVENTIONS: Fifteen patients (1.8%) needed mechanical circulatory support for refractory cardiac failure due to right heart failure (six patients), primary graft failure (three patients), and acute rejection (six patients). Three pump systems were used: Biomedicus Centrifugal Pump, Abiomed BVS 500, and Thoratec VAD. The choice of system depended on the indication and quality of each device. Seven patients (47%) could be weaned from the mechanical circulatory support (MCS) system and three patients (20%) are long-term survivors. RESULTS: All 15 patients developed at least one serious complication, such as multiorgan failure (MOF), liver failure, acute renal failure or sepsis. Twenty-five per cent had severe bleeding and 13% had neurological complication. Mortality was due mostly to MOF, MOF and sepsis or sepsis. The survivors had a CI greater than 2.2 l.min.m2, total bilirubin less than 1.0 U/1, and did not undergo resuscitation. CONCLUSIONS: Heart failure after cardiac transplantation severe enough to require MCS is currently associated with several major complications and high mortality (80%).

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.

Multicenter experience with the thoratec ventricular assist device in children and adolescents.

BACKGROUND: Patient size is 1 determinant in selecting a mechanical circulatory support device. The current pulsatile ventricular assist devices (VADs) were designed primarily for average-sized adults. The flexibility of the Thoratec VAD, however, has encouraged physicians to use it in a significant number of intermediate-sized older children and adolescents. METHODS: We conducted a retrospective study in 58 children and adolescents <18 years (41 boys, 17 girls) who had been supported with the Thoratec VAD in 27 centers worldwide as of December 1999. Mean patient age was 13.8 years (range, 7 to 17 years), and mean patient weight and body surface area were 51.6 kg (range, 17 to 93 kg) and 1.5 m(2) (range, 0.7 to 2.1 m(2)), respectively. RESULTS: Thirty-five patients (60%) survived to transplantation and 6 (10%) to recovery of the native heart, respectively; 38 were discharged from the hospital (66%). In the transplanted group, post-transplantation survival was 97%. Patient age and size were not associated with significantly increased risk for death or adverse events. Fifteen patients (27%) had 18 neurologic events during support, and 6 of these were fatal. Left atrial cannulation proved a risk factor for neurologic complications. CONCLUSIONS: The Thoratec VAD has successfully been used in a large number of children and adolescents with similar morbidity and mortality results as with adults. The risk of neurologic complications may be increased, particularly in patients cannulated in the left atria.