Bridge-to-bridge experience has documented the feasibility of a switch from short-term to long-term mechanical circulatory support until heart transplant. We describe a case of irreversible cardiogenic shock due to giant cell myocarditis treated consecutively with extracorporal membrane oxygenation, bi-ventricular assist device, and total artificial heart. The postoperative course was complicated by human leukocyte antigen sensitization and heparin-induced thrombocytopenia type II. Our patient successfully underwent heart transplant after 10 months of support and was discharged in good condition. This case illustrates suitable device selection for myocarditis and represents two treatable immunological complications.

Aims: Brain natriuretic peptide (BNP) is a hormone, which is synthesized by the ventricular myocardium as a response to mechanical stress. In heart failure BNP is highly upregulated in the plasma. In patients, who are bridged to heart transplantation (HTx) by left ventricular assist devices (LVAD), BNP is downregulated after VAD-implantation due to mechanical unloading of the myocardium. We found profound differences of the BNP-plasma profile after VAD-implantation between different pulsatile LVAD due to construction and/or driving mode of the device. Therefore, we compared the BNP plasma concentrations after LVAD-implantation in pulsatile devices and compared the data to non-pulsatile LVAD.

Objectives: The CorAide™ is an electrically powered, magnetically levitated third generation left ventricular assist system (LVAS), designed for long-term mechanical circulatory support (MCS). We report our initial experience with the CorAide.

Objectives: Application of mechanical circulatory support systems (MCS) for treatment of end-stage cardiac failure or cardiogenic shock is gaining more importance. However, the technology is still expensive and its use is associated with high morbidity and mortality. Identification of risk factors might be helpful in optimizing patient selection and outcome.

BACKGROUND:The use of ventricular assist devices (VAD) has become a widely accepted therapeutic option. However, there are still limitations to the patient collective eligible for VAD placement, who might therefore benefit from the implantation of a total artificial heart. We present the first German single-center experience with the CardioWest total artificial heart (TAH) (SynCardia Systems, Tucson, AZ) in 42 patients.METHODS:Between February 2001 and December 2003, 42 patients (37 men, 5 women, mean age 51 +/- 13 years) received a TAH at our Center. Their body surface area ranged between 1.5 and 2.4 (mean, 1.9 +/- 0.19) m2. All patients were in persistent cardiogenic shock in spite of maximum inotropic support and had numerous preoperative risk factors (intraaortic balloon pumping, mechanical ventilation, acute renal failure, previous cardiac surgery, recent cardiopulmonary resuscitation).RESULTS:Duration of support was 1 to 291 days. Eleven patients (26%) underwent successful transplantation; 9 of them could be discharged home. Twenty-two patients died under support, 21 of them from multiple organ failure and 1 patient from a technical problem. Nine patients are still on the device, 4 of them at home after the original CardioWest console was replaced by the Berlin Heart EXCOR driver (Berlin Heart, Berlin, Germany). Exceptional results were achieved in patients with cardiogenic shock after cardiac surgery or after acute myocardial infarction.CONCLUSIONS:Against the background of the extremely poor preoperative situation of our patients, the overall survival rate of 48% can be considered as favorable. A prospective, randomized study is planned to find out whether patients with idiopathic dilated or ischemic cardiomyopathy are more likely to benefit from a biventricular assist device or a total artificial heart.

Aims: Survival rates of postcardiotomy cardiogenic shock (CS) patients (pts) requiring mechanical circulatory support systems (MCSS) is still poor. This work reports our experience with postcardiotomy CS pts, requiring ECMO or at least three inotropes. Subsequent cardiac replacement with CardioWest-SynCardia (CW) Total Artificial Heart (TAH) was indicated due to prolonged biventricular failure.

Evaluate safety and performance of the first successful third generation implantable LVAS.

Purpose: Many reports have demonstrated the efficacy of ventricular assist devices (VAD’S) as bridge to cardiac transplantation (BTT). However, there are some limitations-technical and medical-in their use. In some terminally ill patients (pts) the CardioWest TAH is more beneficial than a VAD. For these cases, the application of a TAH might open a new therapy window. We report our experience with 22 pts supported with the CardioWest TAH in our center.

Purpose: Long-term mechanical circulatory support (MCS) is gaining more importance, not only as a bridge to transplantation (BTT), but also as destination therapy (ATT). Discharging patients (pts) home improves quality of life. To prove the safety and efficacy of this ambulatory therapy we analyzed data from 105 OOH pts. Methods: Since 1994, 105 inotrope-dependent pts (12 female, 93 male, aged 12–73 years, mean 511, requiring MCS, fulfilled our discharge criteria for OOH treatment. In an ongoing process we analyze causes of readmissions and complications. Devices applied were Novacor LVAD (n = 60), HeartMate LVAD (n=28), Thoratec assist device (n = 12), LionHeart (n = 3) and recently the CardioWest TAH combined with the BerlinHeart Excor driver (n = 2). Intention to treat was BTT in 89 cases, bridge to recovery in 6 and ATT in 10 cases. Results: Mean OOH support was 202 ±217 days (variation 2–1043 days),equal to a cumulative experience of 54.8 pt years. We counted 87 readmissions in 61 pts (readmission rate of 1.8 per payear). At 229 days 50% of the pts were free from readmission. 38 pts were readmitted l×, 17 pts 2×, 2 pts 3 × and in 4 pts we counted ≤ 4 readmissions. Main causes for readmission were neurological disorders (34%) and infections (24%). Conclusion: The readmission rate of 1.8 per payear is acceptable and better than the readmission rate for pts with terminal heart failure on optimal medical therapy. Our results demonstrate the safety and efficacy of the OOH treatment and justify its use in MCS pts suffering from end-stage heart failure.

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.

Introduction: The increasing long-term use of mechanical circulatory support (MCS) not only as bridge to transplantation (BTT) but also as destination therapy (DT) is strongly related to the out-of-hospital (OOH) treatment option. Our experience in > than 100 patients (pts) advocates that it is a safe tool, which guarantees an acceptable quality of life for pts suffering from end-stage cardiac failure. Methods and Patients: Since 1994 111 inotrope dependent pts (12 female, 99 male, aged between 12–74 years, mean 51years) fulfilled our selection criteria (published elsewhere) for OOH MCS. Assist devices used were Novacor LVAD (61 pts), HeartMate I (28 pts), LionHeart (4 pts), Thoratec (11 pts), IVAD (1 pt), DuraHeart (1 pt) and CW TAH with the Berlin Heart Excor driver (5 pts). Intention to treat was BTT in 94 cases, bridge to recovery in 6 cases and DT in 11 cases. All complications and readmissions during OOH treatment and their causes were analyzed. Patients reported regularly QOL by answering the SF 36 questionnaire. Results: Duration of support varied from 2-1043 days (mean 202±217) which is a cumulative experience of 55 patient years. We had 100 readmissions in 65 pts. At 200 days of OOH treatment 50% of our pts were free from readmission. Most frequent causes leading to readmission were neurological disorders (34%) and infections (24%). Minor technical problems occurred in 10% of our pts and in 3% arrhythmias caused readmission. Conclusion: Our results demonstrate the safety and efficacy of the OOH treatment option and advocate its use in MCS pts suffering from end-stage cardiac failure.

Background: Reliable predictors of myocardial recovery after the implantation of a left ventricular assist device (LVAD) is still subject of major investigational work. The aim of our study was to investigate the predictive value of repeated hemodynamic measurements under exercise for myocardial recovery.

Background: Mechanical circulatory support has meanwhile become a generally accepted therapeutic option with a quite large number of patients (pts) undergoing long-term support. The aim of our study was to assess the impact of right ventricular (RV) function and of pump valves after one year of support.

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.

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.Methods: 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.Results: 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 patient died while on LVAD support (24%).Conclusions: 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.

The HeartMate vented electric (VE) left ventricular assist system (LVAS) (TCI; Thermo Cardiosystems Inc, Woburn, Mass) has been used in more than 1400 patients worldwide and in 42 patients in our hospital since November 1995. We experienced a case of fatal mechanical disorder with this device, which required an emergency exchange of the LVAS. The patient was a 34-year-old man who had undergone implantation of the HeartMate VE LVAS because of dilative cardiomyopathy more than 1 year earlier. He was referred to us twice for problems with a cable. In both events, the LVAS worked normally and the patient’s condition was stable. The cable was thoroughly examined and repaired by a technician from TCI. Four days after the second cable repair, the red alarm suddenly warned at home. The manual mechanical pumping with the hand pump was immediately initiated by the patient himself, and he was transferred to our hospital urgently by helicopter. During the transport his condition worsened and he needed to be intubated. This emergency occurred 380 days after the LVAS implantation. The LVAS could still work with the pneumatic system, so that his hemodynamic condition was well controlled with dopamine perfusion. The problem with the LVAS was studied by a technician from TCI. Because dried bloodlike material was observed in the hand pump and the stroke volume limiter connecting tube, we suspected a rupture of the drive line or the diaphragm separating the blood pump chamber from the motor chamber in the LVAS. We exchanged the LVAS through the incision in the abdominal pocket with cardiopulmonary bypass established through the femoral artery and vein. The postoperative course was excellent. He was discharged to his home on postoperative day 24 and is now waiting for heart transplantation. The explanted pump was carefully examined. The motor chamber was filled with clotted dried blood, which prevented the motor/cam assembly from working (Fig 1). However, by macroscopic observation we could not find any tears or holes in the diaphragm. The pump was sent to TCI for precise inspection. TCI’s technicians detected small tears at the rim of the diaphragm, which might have been caused by mechanical fatigue. The TCI HeartMate LVAS is one of the most reliable systems in the world. 1Oz MC Argenziano M Catanese KA Gardocki MT Goldstein DJ Ashton RC et al.Bridge experience with long-term implantable left ventricular assist devices.Circulation. 1997; 95: 1844-1852Crossref PubMed Scopus (187) Google Scholar, 2Massad MG McCarthy PM Will permanent LVADs be better than heart transplantation?.Eur J Cardiothorac Surg. 1997; 11: S11-S17Crossref PubMed Scopus (9) Google Scholar We have implanted the pneumatic HeartMate LVAS in 14 patients since April 1994 and the VE HeartMate LVAS in 28 patients since November 1995.3El-Banayosy A Minami K Arusoglu L Fey O Kitzner L Hartmann D et al.Long-term mechanical circulatory support.Thorac Cardiovasc Surg. 1997; 45: 127-130Crossref PubMed Scopus (6) Google Scholar A similar device disorder with the VE HeartMate LVAS was reported by Piccione and colleagues4Piccione W Kao WG Mattea A Rodriguez ER Trohman RG Failure of an implantable left ventricular assit device: a distinctive electrocardiographic pattern before malfunction.J Thorac Cardiovasc Surg. 1998; 115: 1376-1378Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar in 1998. They showed, as in this report, that the motor chamber filled with clotted blood. However, they could not find any perforation on the drive line, and they did not refer to the diaphragm. To our knowledge, this is the first report of a disorder of the diaphragm in the pump with the VE HeartMate LVAS. The support time of this patient was 380 days. This long support time might be one of the reasons for this defect.