CardioWest Total Artificial Heart: Bad Oeynhausen Experience

doi:10.1016/j.athoracsur.2005.02.084

The Annals of Thoracic Surgery

Volume 80, Issue 2, August 2005, Pages 548-552

https://doi.org/10.1016/j.athoracsur.2005.02.084 Get rights and content

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.

Section snippets

Selection Criteria

Since the CardioWest TAH became available at our Center in February 2001, our previously published [2] selection criteria for patients scheduled for biventricular support have been modified. Patients with severe cardiogenic shock resulting in extensive multiple organ failure and a body surface area of more than 1.5 m² are now more likely to receive the CardioWest TAH. This also applies to patients after massive myocardial infarction in whom a left ventricular or biventricular device cannot be

Results

The implantation procedure was uneventful in all patients without any intraoperative fatality. Eight patients (most of them after acute myocardial infarction) had fit problems and chest closure was only possible on PODs 2–5. Three of these patients had a body surface area less than 1.7 m². However, fit problems were not observed in three other patients with a body surface area less than 1.7 m². A bleeding complication defined as blood loss greater than 1,500 cc · m² · 24 hours occurred in 9

Comment

Although a variety of devices for mechanical circulatory support have become available, patients with intracardiac thrombi or shunts, structural damage to the heart, or congenital heart defects are not eligible for the implantation of these assist devices but need a total artificial heart in case of endstage heart failure. This paper describes the application of the CardioWest TAH in one of the sickest patient cohort receiving mechanical circulatory support ever reported as shown by their

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Cited by (63)

Outcomes after heart transplantation and total artificial heart implantation: A multicenter study
2021, Journal of Heart and Lung Transplantation
We sought to assess the outcomes after heart transplantation (HT) of patients supported with a temporary total artificial heart (t-TAH) as a bridge to transplantation in high-volume centers.
A retrospective analysis of 217 consecutive patients who underwent t-TAH (SynCardia Systems, Tucson, Arizona) implantation between January 2014 and May 2019 in 6 high-volume North American centers was performed. End points included survival and adverse events after t-TAH and HT.
The mean age of patients was 49 ± 12 years, and heart failure etiologies were non-ischemic dilated cardiomyopathy (36%), ischemic (25%), restrictive (12%), and cardiac graft failure (9%). A total of 101 (48%) patients had Interagency Registry for Mechanically Assisted Circulatory Support patient profile 1, and 65 (31%) had Interagency Registry for Mechanically Assisted Circulatory Support patient profile 2. At the end of the study period, 138 of 217 (63.5%) patients had undergone HT, and 75 (34.5%) patients died before HT. The mean time between t-TAH implantation and HT averaged 181 ± 179 days (range: 0–849) and the mean follow-up after HT was 35 ± 25 months. The overall survival in the entire cohort was 75%, 64%, and 58% at 1, 2, and 5 years, respectively. Post-transplant survival was 88%, 84%, 79%, and 74% at 6 months, 1 year, 2 years, and 5 years, respectively. Among the 32 patients (23%) who died after HT, the main causes of death were chronic allograft vasculopathy (25%), multiorgan failure (21.8%), sepsis (15.6%), and stroke (9%).
In this multicenter study, almost two thirds of patients implanted with a t-TAH could be transplanted. The overall and post-transplantation survival after t-TAH was satisfactory in these critically ill patients.
Predictors of Renal Failure in Patients Treated With the Total Artificial Heart
2020, Journal of Cardiac Failure
The incidence of hemodialysis (HD)-dependent renal failure after total artificial heart (TAH) implantation is high. We sought to determine the preoperative predictors of HD after TAH implantation.
We studied 87 patients after TAH implantation at our institution between April 2006 and March 2017. Baseline clinical data were obtained from the medical records, and patients were followed until death or heart transplantation. We performed logistic regression analysis to identify predictors of HD after TAH implantation. Of the patients, 24 (28%) required postimplantation HD. Those requiring HD were more likely to have histories of coronary artery disease (58% vs 29%; P = 0.01), required preoperative membrane oxygenation (33% vs 4.8%; P = 0.001) and had lower baseline estimated glomerular filtration rates (54 ± 29 vs 67 ± 24 mL/min/1.73m²; P = 0.04). Patients requiring HD were at a higher risk of death on device at 1 year (33% vs 5%, P = 0.001; log rank test: P =0.001, hazard ratio 6.6 [95% CI:1.8–23], P = 0.003).
The incidence of postimplantation HD is high and is associated with increased likelihood of mortality. Lower baseline estimated glomerular filtration rates, histories of coronary artery disease and preoperative membrane oxygenation support are predictors of postimplantation requirement of HD. These data may help to identify patients at risk for adverse outcomes after TAH implantation.
Status, Indications, and Use of Cardiac Replacement Therapy in the Era of Multimodal Mechanical Approaches to Circulatory Support: A Scoping Review
2020, Canadian Journal of Cardiology
Citation Excerpt :
Quality assessment of the included studies was performed with the use of the ROBINS-I tools.31 Five studies published from 2005 to 2014 were retained.26,32-35 All of the studies showed at least a moderate risk of bias according to the ROBINS-I tools.
The aim of this review is to describe the current use, indications, and outcomes of the Syncardia temporary total artificial heart (TAH) (Syncardia Systems, Tucson, AZ, USA), the only TAH currently approved as a bridge-to-transplant strategy in Canada, the United States, and Europe. With more than 1700 implantations worldwide, the Syncardia temporary TAH is the most commonly used pump. Globally, it represents 2% of the long-term mechanical circulatory support devices implanted, with a recent decrease in its use. The main candidates for TAH are heart transplant candidates suffering from acute or decompensated chronic irreversible biventricular failure at high risk of imminent death and for whom a suitable donor is not available. Most patients receiving a TAH are acutely ill, characterized by an INTERMACS profile of 1 or 2, and 20% are under extracorporeal membrane oxygenation. The TAH provides efficient circulatory support and allows the end-organ to recover from the initial hypoperfusion injury. More than 60% of patients implanted with a Syncardia TAH will later undergo transplantation, with a 1-year survival rate of 70% after transplantation, compared with a 1-year survival rate of ∼ 42% in nontransplant patients. Bleeding, infection, stroke, and acute kidney injury are the most common complications in this critically ill population. The new miniaturization of the console (Freedom Portable Driver) facilitates the recovery of TAH recipients by allowing ambulation, aggressive physiotherapy, and, eventually, hospital discharge. This last aspect is one of the main benefits of TAH compared with other biventricular assist devices. In conclusion, the Syncardia temporary TAH is a reasonable bridge-to-transplant option for selected patients with either biventricular failure or special anatomic conditions.
Les auteurs décrivent l’utilisation, les indications et les résultats actuels du cœur artificiel total (CAT) temporaire Syncardia (Syncardia Systems, Tucson, AZ, États-Unis), le seul CAT actuellement approuvé comme stratégie de transition vers une transplantation au Canada, aux États-Unis et en Europe. Implanté chez plus de 1 700 patients dans le monde, le CAT temporaire Syncardia est la pompe la plus utilisée. À l’échelle mondiale, il représente 2 % des dispositifs d’assistance circulatoire mécanique de longue durée implantés, bien que l’on constate depuis peu une diminution de son emploi. Les principaux candidats à un CAT sont des patients en attente d’une transplantation cardiaque souffrant d’une défaillance biventriculaire irréversible chronique aiguë ou décompensée et présentant un risque élevé de décès imminent, pour qui aucun donneur compatible n’est disponible. La plupart des patients qui reçoivent un CAT sont très malades et présentent un score INTERMACS de 1 ou 2; 20 % d’entre eux sont sous oxygénation extracorporelle par membrane. Le CAT offre une assistance circulatoire efficace et permet aux organes cibles de se rétablir après l’épisode d’hypoperfusion initial. Plus de 60 % des patients à qui on implante un CAT Syncardia subissent par la suite une transplantation et affichent un taux de survie à 1 an de 70 % après la greffe, comparativement à un taux de survie à 1 an de 42 % environ chez les patients qui ne subissent pas de transplantation. Les hémorragies, les infections, l’accident vasculaire cérébral et l’atteinte rénale aiguë sont les complications les plus courantes au sein de cette population gravement malade. La nouvelle console miniaturisée (Freedom Portable Driver) facilite le rétablissement des patients qui reçoivent un CAT, car elle leur permet de se déplacer, de suivre une physiothérapie intensive et, finalement, de recevoir leur congé de l’hôpital. Ce dernier point est l’un des principaux avantages d’un CAT par rapport aux autres dispositifs d’assistance biventriculaire. En conclusion, le CAT temporaire Syncardia constitue une option valable pour la transition vers une transplantation chez certains patients présentant une défaillance biventriculaire ou des caractéristiques anatomiques particulières.
Current types of devices for durable mechanical circulatory support
2019, Mechanical Circulatory Support: A Companion to Braunwald’s Heart Disease
Like most technologies, mechanical circulatory support devices have rapidly evolved since their invention. The left ventricular assist device (LVAD) has become smaller and more durable, which has enhanced reliability and biocompatibility. Durable LVADs and the total artificial heart have become mainstay therapy for advanced stage heart failure. State of the art mechanical circulatory support systems are described in this chapter. The history, function and research regarding devices are detailed. Overall, extensive clinical research has demonstrated that these devices are safe and effective when used for bridging to transplantation and myocardial recovery, or for lifetime destination therapy. In addition, adverse event rates have declined as survival has increased. Ongoing research is targeted at reducing adverse events and expanding the population of treatable patients. Further, additional research targets less-invasive implantation techniques and transcutaneous energy transmission, which may help to minimize trauma and infection related complications.
How should cardiogenic shock be managed (including assist devices)?
2019, Evidence-Based Practice of Critical Care
: Cardiogenic shock (CS) refers to the inability to deliver oxygen effectively due to cardiac dysfunction. Causes of CS are multifactorial but most often are seen in the setting of acute myocardial infarction. Diagnosis can be difficult because CS may coexist in the presence of other forms of shock. Evaluation through a history and physical examination can often yield a diagnosis and be confirmed through echocardiography. With newer training in bedside ultrasound, this can now be performed with accuracy by the critical care physician. Treatment of CS is accomplished through a multidisciplinary approach and a combination of medical therapies, medical devices, and revascularization.
Interagency registry for mechanically assisted circulatory support report on the total artificial heart
2018, Journal of Heart and Lung Transplantation
We sought to better understand the patient population who receive a temporary total artificial heart (TAH) as bridge to transplant or as bridge to decision by evaluating data from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database.
We examined data related to survival, adverse events, and competing outcomes from patients who received TAHs between June 2006 and April 2017 and used hazard function analysis to explore risk factors for mortality.
Data from 450 patients (87% men; mean age, 50 years) were available in the INTERMACS database. The 2 most common diagnoses were dilated cardiomyopathy (50%) and ischemic cardiomyopathy (20%). Risk factors for right heart failure were present in 82% of patients. Most patients were INTERMACS Profile 1 (43%) or 2 (37%) at implantation. There were 266 patients who eventually underwent transplantation, and 162 died. Overall 3-, 6-, and 12-month actuarial survival rates were 73%, 62%, and 53%, respectively. Risk factors for death included older age (p = 0.001), need for pre-implantation dialysis (p = 0.006), higher creatinine (p = 0.008) and lower albumin (p < 0.001) levels, and implantation at a low-volume center (≤10 TAHs; p < 0.001). Competing-outcomes analysis showed 71% of patients in high-volume centers were alive on the device or had undergone transplantation at 12 months after TAH implantation vs 57% in low-volume centers (p = 0.003).
Patients receiving TAHs have rapidly declining cardiac function and require prompt intervention. Experienced centers have better outcomes, likely related to patient selection, timing of implantation, patient care, and device management. Organized transfer of knowledge to low-volume centers could improve outcomes.

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Original articleCardiovascularCardioWest Total Artificial Heart: Bad Oeynhausen Experience

Background

Methods

Results

Conclusions

Section snippets

Selection Criteria

Results

Comment

Ann Thorac Surg

J Heart Lung Transplant

J Heart Lung Transplant

Ann Thorac Surg

Original article
Cardiovascular
CardioWest Total Artificial Heart: Bad Oeynhausen Experience