Total Artificial Heart Support Research Articles

Heart Transplant Outcomes After Total Artificial Heart

We sought to compare heart transplant (HTX) outcomes from patients with a total artificial heart (TAH), biventricular assist device (BiVAD), or left ventricular assist device (LVAD) as a bridge to transplant (BTT). Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS)-Scientific Registry of Transplant Recipients (SRTR) created a dataset with TAH or durable mechanical circulatory support (MCS) who reached HTX between 2006 and 2015. The retrospective analysis compared TAH outcomes with those with a BiVAD or LVAD before HTX. The primary outcome was posttransplant survival at 1, 36, and 60 months. Secondary outcomes included simultaneous heart-kidney transplants, donor characteristics, and mortality risk factors. INTERMACS-SRTR cohort had, at the time of HTX, 2762 patients with LVAD; 205 BiVAD (139 durable and 66 temporary RVAD); 176 TAH (6 prior HeartMate II). Sixty months after HTX, mortality rates were 16.5% in the total group: LVAD 15.2%, BiVAD 22.4%, and TAH 29%. Survival differed between the LVAD, the TAH, and BiVAD but not between the BiVAD and TAH groups. One-year survival and complication rates were similar across groups-there was no difference in survival by donor age in the overall cohort. There was a difference in TTD based on recipient age in the LVAD group but not in BiVAD or TAH groups. Occurrence of HTX-kidney and post-transplant dialysis were higher in the TAH versus LVAD and BiVAD groups. The TAH is an efficacious BTT. Refinements in technology and patient selection may improve outcomes.

HeartMate-3 Ventricular Assist Devices Versus the Total Artificial Heart for Biventricular Support: A Single-Center Series.

The SynCardia total artificial heart (TAH) is the only device approved for biventricular support. Continuous flow ventricular assist devices (VAD) in a biventricular configuration (BiVAD) have been used with variable results. The purpose of this report was to examine differences in patient characteristics and outcomes between two HeartMate-3 (HM-3) VADs in comparison with TAH support. All patients who received durable biventricular mechanical support from November 2018 to May 2022 at The Mount Sinai Hospital (New York) were considered. Baseline clinical, echocardiographic, hemodynamic, and outcome data were extracted. Primary outcomes were postoperative survival and successful bridge-to-transplant (BTT). A total of 16 patients received durable biventricular mechanical support during the study period, of which 6 (38%) patients received two HM-3 VAD pumps as BiVAD support and 10 (62%) patients received a TAH. Overall, TAH patients had a lower median lactate ( p < 0.05) at baseline compared to those on HM-3 BiVAD support yet had higher operative morbidity, lower 6-month survival ( p < 0.05), and a higher rate of renal failure (80 vs . 17%; p = 0.03). However, survival declined to the same rate at 1 year (50%) and was largely because of extracardiac adverse events related to underlying comorbidities (particularly, renal failure and diabetes, p < 0.05). Successful BTT was achieved in 3 out of 6 HM-3 BiVAD patients and in 5 out of 10 TAH patients. In our single center experience, similar outcomes were observed among patients BTT with HM-3 BiVAD compared to those BTT on TAH support despite lower Interagency Registry for Mechanically Assisted Circulatory Support level.

Abstract 15813: Comparative Case Series of Biventricular Support Between Heartmate-3 Ventricular Assist Devices and the Total Artificial Heart: A Single-Center Experience

Introduction: Currently, only the Syncardia Total Artificial Heart (TAH) is approved for biventricular support as a bridge-to-transplant (BTT). The off-label use of continuous flow ventricular assist devices (VAD) in a biventricular configuration (BiVAD) has been used with variable results, emphasizing the need for patient selection. We report our single-center BiVAD experience in patients supported with two HeartMate-3 (HM-3) VADs in a biventricular configuration in comparison with TAH support. Methods: All patients receiving durable biventricular mechanical support at The Mount Sinai Hospital (New York, New York) were considered. Baseline clinical, echocardiographic, hemodynamic and outcome data were extracted. Outcomes of interest were postoperative survival and adverse events, and compared using non-parametric statistics. Successful BTT and post-transplant survival were descriptively evaluated. Results: From November 2018 through May 2022, a total of 6 (37.5%) patients received two HM-3 VAD pumps in a BiVAD configuration and 10 (62.5%) patients received a TAH. Overall, TAH patients had significantly higher median INTERMACS profiles (p &lt; 0.05) at baseline compared to those on HM-3 BiVAD support but lower 30-day and 6-month survival and with a significantly higher rate of renal failure (Table 1). However, survival declined to the same rate at 1-year with both forms of support and was largely due to extracardiac adverse events related to underlying comorbidities (particularly, CKD/ESRD and diabetes, p &lt; 0.05). Successful BTT has thus far been achieved in 2 (33%) HM-3 BiVAD compared to 5 (50%) TAH patients, and had similar post-transplant survival at 1-year. Conclusions: HM-3 BiVAD demonstrated lower short-term and similar long-term mortality compared to TAH support among patients in extremis. However, larger studies are needed to optimize patient selection and pursuit of mechanical support in biventricular failure.

P91: Novel management approach utilizing CardioMEMS™ HF system in a pediatric patient on Total Artificial Heart support with concurrent pulmonary arterial hypertension – A case report

P91: Novel management approach utilizing CardioMEMS™ HF system in a pediatric patient on Total Artificial Heart support with concurrent pulmonary arterial hypertension – A case report

Total artificial heart implantation as a bridge to transplantation in the United States

ObjectivesAlthough the SynCardia total artificial heart (SynCardia Systems, LLC) was approved for use as a bridge to transplantation in 2004 in the United States, most centers do not adopt the total artificial heart as a standard bridging strategy for patients with biventricular failure. This study was designed to characterize the current use and outcomes of patients placed on total artificial heart support. MethodsThe United Network of Organ Sharing Standard Transplant Research File was queried to identify total artificial heart implantation in the United States between 2005 and 2018. Multivariable Cox regression models were used for risk prediction. ResultsA total of 471 patients (mean age, 49 years; standard deviation, 13 years; 88% were male) underwent total artificial heart implantation. Of 161 transplant centers, 11 centers had cumulative volume of 10 or more implants. The 6-month cumulative incidence of mortality on the total artificial heart was 24.6%. The 6-month cumulative incidence of transplant was 49.0%. The 1-year mortality post-transplantation was 20.0%. Cumulative center volume less than 10 implants was predictive of both mortality on the total artificial heart (hazard ratio, 2.2, 95% confidence interval, 1.5-3.1, P < .001) and post-transplant mortality after a total artificial heart bridge (hazard ratio, 1.5, 95% confidence interval, 1.0-2.2, P = .039). ConclusionsTotal artificial heart use is low, but the total artificial heart can be an option for biventricular bridge to transplant with acceptable bridge to transplant and post-transplant survival, especially in higher-volume centers. The observation of inferior outcomes in lower-volume centers raises questions as to whether targeted training, center certifications, and minimum volume requirements could improve outcomes for patients requiring the total artificial heart.

Trends and outcomes following total artificial heart as bridge to transplant from the UNOS database.

Bridge to transplantation (BTT) with a SynCardia Total Artificial Heart (TAH) has been gaining momentum as a therapy for patients with biventricular heart failure. Recent transplant waitlist and posttransplant outcomes with this strategy have not been comprehensively characterized. We reviewed the United Network for Organ Sharing (UNOS) database to examine BTT outcomes for the TAH system since approval. Adult patients listed for heart transplantation in the UNOS system between 2004 and 2020 who underwent BTT therapy with a TAH were included in the study. Trends in utilization of TAH compared with other durable mechanical support strategies were examined. The primary outcome was 1-year survival following heart transplantation following BTT with TAH. Secondary outcomes included waitlist deterioration and risk factors for waitlist or posttransplant mortality. During the study 433 total patients underwent TAH implant as BTT therapy; 236 (54.4%) were listed with the TAH, while the remaining patients were upgraded to TAH support while on the waitlist. Waitlist mortality was 7.4%, with 375 patients (86.6%) ultimately being transplanted. Age, cerebrovascular disease, functional status, and ventilator dependence were risk factors for waitlist mortality. One-year survival following successful BTT was 80%. Risk factors for mortality following BTT included age, body mass index, and underlying diagnosis. Patients undergoing BTT with TAH demonstrate acceptable waitlist survival and good 1-year survival. While utilization initially increased as a BTT therapy, there has been a plateau in relative utilization. Individual patient and transplantation center factors deserve further investigation to determine the ideal population for this therapy.

Ethical Issues in the Deactivation of Total Artificial Heart Support – A Systematic Review

"Introduction: In the context of a relatively constant heart donation rate, the effort to satisfy the needs, has led to the development of mechanical devices that can replace the cardiac function. Estimating an annual potential of 100,000 artificial heart implants in the United States alone, there is an increased interest in these devices, which is why it is appropriate to explore the situations where its inactivation may be ethically appropriate. Method: We performed a systematic review, which includes all the studies regarding the dilemma of artificial hearts inactivation from the beginning until 2020, published in PubMed, Embase and Scopus. The searched keywords were “totally artificial heart and ethics”; the duplicate studies and those referring to other cardiac support devices were excluded. Results: Following the selection, 12 articles were included in the review. The conflict between the principle of discontinuity and the prohibition generated by the indispensability of the artificial heart was emphasized. The decision to inactivate the support dependent on the patient’s declared level of happiness or clinical evolution over time was reviewed. The dilemma of self-inactivation of artificial cardiac support as suicide versus the acceptance of death caused by the underlying heart condition, as well as the impact of total removal of the native heart were included in the ethical analysis. Conclusions: Requests for withdrawal of TAH support are not uncommon among patients, their discontinuation being ethically acceptable when it does not serve the patient’s interests, even though they may still be capable to prolong their life. "

P0696 / #465: WHEN DIVERTING COLOSTOMY PERFORM TO CRITICAL ILLNES FOR SEVERE PERIANAL OPEN WOUNDS?

Aims & Objectives: The aim of the present study was to analyze the outcome after performing a diversion colostomy in children with severe perianal lesion. Methods: We are presenting to case series whose diverting colostomy was opened for large perianal open wounds and sepsis. Results: Our first patient was 6-month girl whose diagnosed with meningococcemia had extensive necrotizing wounds in the perianal region, a colostomy performed (on the 40th day hospitalization) to prevent stool passage and skin irritation. In the follow-up of the patient, wound healing was observed and no additional problem was observed. It was learned that the patient’s colostomy was closed in the 5th month. Second patient was 7-moth girl, also she was diagnosed meningococcemia along with severe purpura fulminans then extensive necrotizing wounds in the perianal region, a colostomy performed (on the 23th day of admission). The patient is still in our hospital and has colostomy. The patient was in good general condition. Third patient’s disorder was dilated cardiomopathy and then total artificial heart support implanted because of failure. He had extensive sacral decubitus ulcer and a colostomy performed (on the 58th day of hospitalization). After healing of the patient’s wound, colostomy was closed in the 10th month hospitalization. We achieved successful results in 3 patients.Conclusions: In conclusion, the present study is the first to case series the use of diverting colostomy method for critically ill children sever and large open perianal wounds. Colostomy may be good treatment option for perineal severe tissue lost.

A heart transplant after total artificial heart support: initial and long-term results.

At our centre, the SynCardia temporary Total Artificial Heart (TAH-t) (SynCardia Systems, LLC, Tucson, AZ, USA) is used to provide long-term support for patients with biventricular failure as a bridge to a transplant. However, a heart transplant (HT) after such support remains challenging. The aim of this retrospective study was to assess the immediate and long-term results following an HT in the cohort of patients who had a TAH-t implant. A total of 73 patients were implanted with the TAH-t between 1988 and 2019 in our centre. Of these 73 consecutive patients, 50 (68%) received an HT and are included in this retrospective analysis of prospectively collected data. In the selected cohort, in-hospital mortality after an HT was 10% (n = 5). The median intensive care unit stay was 33 days (range 5-278). The median hospital stay was 41 days (range 28-650). A partial or total pericardiectomy was performed during the HT procedure in 21 patients (42%) due to a severe pericardial reaction. Long-term survival rates after an HT at 5, 10 and 12 years were 79.1 ± 5.9% (n = 32), 76.5 ± 6.3% (n = 22) and 72.4 ± 7.1% (n = 12), respectively, which was similar to the long-term survival for a primary HT without TAH-t during the same period (n = 686). An HT performed within 3-6 months post-TAH-t implantation appeared to provide the best survival (P = 0.007). Eight (16%) patients required chronic dialysis during the subsequent follow-up period, with 3 patients requiring a kidney transplant. The long-term outcomes with the SynCardia TAH-t as a bridge to transplant in patients with severe biventricular failure are very encouraging. Our review noted that an HT following TAH-t can be technically challenging, especially in the case of a severe pericardial reaction, with potential pitfalls that should be recognized preoperatively.

Right Ventricular Device HeartWare Implant to the Right Atrium with Fixation to the Chest Wall in Patient with Biventricular Support.

Right Ventricular Device HeartWare Implant to the Right Atrium with Fixation to the Chest Wall in Patient with Biventricular Support.

Biventricular Support with Syncardia Total Artificial Heart: Long-Term Single-Center Experience

The SynCardia Total Artificial Heart (TAH) is a pneumatically driven assist system to provide mechanical circulatory support in patients with severe non-reversible biventricular failure, who otherwise have no mechanical support devices. The aim of our retrospective study is to assess the comorbidity and survival of patients awaiting cardiac transplant while circulatory support with TAH. We examined data related to survival, adverse events, and outcomes from patients undergoing TAH implantation between Januar 2001 and September 2019. For determination of the predictors for mortality we used multivariate analysis. Between February 2001 and September 2019, a total of 190 consecutive patients (88.9% men; mean age, 53±11.6 years,) underwent TAH implantation. Indications for TAH implantation were cardiomyopathy in 84 (44.2%), acute myocardial infarction in 50 (26.3%) and postcardiotomy biventricular heart failure in 29 (15.3%) and others (allograft rejection, myocarditis, endocarditis, congenital heart disease) in 27 patients (14.2%). The majority of patients (166/87.4%) were in INTERMACS profile 1, the remainder (24/12.7%) in INTERMACS profiles 2-3. Preoperative measures of the creatinine was 2.0±1.3 mg/dl and total bilirubin 3.0±3.8 mg/dl. The median support time was 169 days (range, 1 to 971 days). During TAH support, 32.1% of patients suffered from stroke, 30.5% from mesenteric ischemia and 24.2% from gastrointestinal bleeding. The median follow-up for survival of patients on support was 4.3 months. The 1-, 6- and 12-month survival was 71%, 42% and 35%, respectively. A total of 120 (63.2%) patients died during support. The most common causes of the death were multiorgan failure or/with sepsis. Multivariate analysis revealed that age p=0.003), underweight with BMI <18.5 kg/m² (p=0.001), higher total bilirubin (p=0.007) and preoperative IABP (p=0.013) were independent predictors for mortality during support. Sixty-nine (35.3%) were successfully bridged to transplantation after a mean support time of 311±205 days. 1-, 5- and 10-year survival was 64%, 58% and 51%, respectively. SynCardia TAH provides acceptable outcomes in critically sick patients with irreversible heart failure who are candidates for cardiac transplantation. More than one third of our TAH-patients were be successfully bridged to transplantation.

Evolving understanding of total artificial heart support of young infants and children

BackgroundWe have developed a new method of total artificial heart (TAH) support for young patients, and here share our preliminary results and evolving understanding. MethodsThis report is a retrospective chart review of all patients <10 kg who received a TAH at our institution from May 2017 to the time of this report. ResultsOur cohort includes 5 patients. Two had single-ventricle circulation, 1 of whom had undergone a Glenn procedure and was revised back to a Sano shunt. Four were on extracorporeal life support for longer than 10 days, 3 with an open chest. In these 3 patients, the TAH was a salvage operation. Centrifugal pumps were used for 2 patients and pulsatile pumps for 3 patients. Three patients survived to transplantation and discharge, with support times of 79, 44, and 96 days; in these patients, the duration of follow-up from discharge to the time of this report was 687, 19, and 8 days, respectively, and all patients were well. For the pulsatile pumps, in the first patient we placed valved conduits for inflow connections. For the second patient, we omitted the valved conduits and oversized the pumps to avoid full fill; yet, despite our best efforts, full fill occurred frequently, and thus we converted to a systemic centrifugal pump. ConclusionsOur method of TAH support can be tailored to provide effective support of carefully selected young children with single or biventricular physiology. In our opinion, for pulsatile pumps, oversizing the pump and using valved inflow conduits may be important adjuncts to achieve effective support.

Initial United Kingdom experience with the syncardia total artificial heart

Introduction The SynCardia Total Artificial Heart (TAH) is a form of mechanical circulatory support where the patient's native ventricles and valves are explanted and replaced by a pneumatically powered artificial heart (1). Implantation is indicated in patients with irreversible biventricular cardiac failure (2). We have recently initiated a TAH program at Harefield Hospital for the UK patient population. The aim of this study is to review our initial experience in terms of success rate of bridging patients to transplantation and post cardiac transplant outcomes. Methods We analysed data from all patients who received a TAH from July 2014 until April 2019 at our institution to quantify the rate of successful bridging to transplantation and the subsequent post cardiac transplant outcomes. Results 22patients (males, n = 14; mean age 39 ± 17) received TAH implants due to severe, irrecoverable biventricular failure. Aetiologies were dilated (n = 11, 50%), ischaemic (n = 6, 27%) and valvular (n = 3, 13%) cardiomyopathies. 12 patients (55%) were on veno-arterial extra corporeal membrane oxygen support with mean duration of 8.3 ± 8.6 days prior to TAH implantation. Mean duration on TAH support was 95 ± 114 days. 7 patients (32%) suffered stroke, 8 (36%) required surgical exploration for bleeding and 7 (32%) developed sepsis. 9 patients (40%) were successfully bridged to and received a heart transplant, another 3 patients are on the waiting list. 6 patients (27%) are still living: 3 post heart transplantation and 3 remain on the waiting list for a heart transplant. Discussion We have successfully introduced The TAH program in the UK as an important and unique intervention for a high risk patient population with biventricular heart failure who are not candidates for left ventricular assist device. Despite high rate of perioperative and early mortality and postoperative complications TAH implantation provides a realistic alternative for these otherwise futile cases.

SynCardia, total artificial heart, as a bridge to transplant.

Implantation of a total artificial heart is an alternative to durable biventricular assist device support in selected patients. We present our initial experience with the implantation of the SynCardia total artificial heart (TAH) in three patients. The first patient, was the first SynCardia (TAH) implantation in the Visegrad Four (V4) countries METHOD: Three patients with severe refractory end stage biventricular heart failure listed for heart transplant were indicated for SynCardia TAH implantationRESULTS: We present in details the perioperative and postoperative outcomes of these patients. The first and the third patient, after 195 and 126 days of TAH support respectively, had asuccessful heart transplants, the second patient died on 11th postoperative day. The cause of death was brain bleeding due to ruptured undiagnosed brain aneurysm. SynCardia TAH is an alternative therapy in patients with end-stage biventricular heart failure waiting for heart transplantation. The SynCardia TAH with pulsatility resembles the physiologic circulation, improves the condition of the patients and increases survival compared to the biventricular assist devices. It is an intermediate step until the development of genetically modified animal hearts, engineered bioartificial hearts or hearts from induced pluripotent stem cells that would replace the failing heart in the patients with end-stage heart disease (Tab. 2, Fig. 1, Ref. 27).

Abstract 16732: Differential Association of Various Cardiac Hemodynamic Parameters With Renal Dysfunction in End-Stage Heart Failure Patients

Introduction: Decreased cardiac output is often thought to be the main determinant of renal dysfunction in patients with heart failure. However, large cohort studies are lacking to show these correlations in patients with end stage heart failure. Methods: We selected all adult patients between 2007-2016 who were listed for heart transplant (n=11,030) after excluding those on life support, inotropes, nitric oxide, total artificial heart, percutaneous mechanical or ECMO support, dialysis dependent, biventricular or only right ventricular assist device support and with prior heart or kidney transplant using the United Network for Organ Sharing database. We evaluated associations between renal function and three hemodynamic parameters: 1) cardiac index (CI), 2) mean pulmonary artery pressure (mPA) and 3) pulmonary vascular resistance (PVR) using robust regression models. Results: Average age of patients was 53.5±12.3 years (23% females) with mean estimated glomerular filtration rate (eGFR) of 71.7±26.2 mL/min/1.73m 2 . Nearly half (49%) of the patients had left ventricular assist devices (LVAD) with mPA pressure of 26.2±9.9 mmHg and average CI of 2.4±0.7. There was an inverse correlation between mPA pressure and eGFR (p&lt;0.001) however no association between CI and eGFR (p=0.853); or between PVR and eGFR (p=0.989). After multivariate adjustment, mPA pressure was inversely correlated with eGFR (p&lt;0.001). Subgroup analysis of individuals with LVADs (N=5,417) showed similar results with significant inverse relations between mPA and eGFR (p= 0.008) and no significant correlation between PVR or CI and eGFR (p&gt;0.2 for both). Analysis restricted to individuals with low CI (&lt; 1.8 L/min/m 2 ) and PVR &lt; 4 Woods Units (n=8376) also showed inverse linear correlation between mPA pressures up to 45 mmHg and eGFR (p&lt;0.001). Conclusions: Among patients with end stage heart failure, higher mPA pressure and not the lower cardiac index are cross-sectionally related to lower eGFR values.

Impact of Mechanical Circulatory Support on Posttransplant Outcomes

Mechanical circulatory support (MCS) has markedly improved the likelihood of transplant among patients with advanced heart failure. Transplant survival following MCS is similar for supported and unsupported recipients. Transplant survival is only reduced following left ventricle assist device (LVAD) support complicated by infection, total artificial heart support, and extracorporeal life support. Despite allosensitization and a higher incidence of vasoplegia syndrome, posttransplant survival for durable LVADs is similar to patients with inotropes alone at the time of transplant. MCS as a bridge to transplant offers significant benefits over waiting without support.

Pulmonary Pressure Assessment with the Total Artificial Heart.

Reversal of pulmonary hypertension has been observed in patients during a bridge to transplant with a left ventricular assist device. Total artificial heart (TAH) implant prevents subsequent right heart catheterization. Consequently, controversy exists over whether the prosthetic right ventricle improves or exacerbates pulmonary hypertension. A pulmonary artery (PA) pressure monitor was placed in two patients undergoing TAH implant, as a bridge to transplant. One patient had pulmonary hypertension at implant; the other had normal pulmonary pressures. Daily measurements were taken of systolic, diastolic, and mean PA pressures throughout support. Patient 1 received successful transplant after TAH support of 91 days. Systolic/diastolic (mean) PA pressures steadily decreased from 55/39 (28) mm Hg at implant to 29/18 (7) mm Hg currently. Patient 2 received support for 101 days before death due to abdominal ischemic complications. Pulmonary arterial pressures stayed consistent throughout this period, from 26/17 (20) mm Hg at implant to 23/13 (17) mm Hg at the time of death. These findings suggest that an implantable PA pressure monitor may be useful in optimizing hemodynamics and planning appropriate timing of transplant with TAH support.

Experience with the SynCardia total artificial heart in a Canadian centre.

The SynCardia total artificial heart (TAH) provides complete circulatory support by replacing both native ventricles. Accepted indications include bridge to transplantation and destination therapy. We review our experience with TAH implantation during a period when axial flow pump became available. We retrospectively analyzed the demographics, clinical characteristics and survival of all patients receiving the TAH. From September 2004 to November 2016, 13 patients (12 men, mean age 45 ± 13 yr) received the TAH for refractory cardiogenic shock secondary to idiopathic (56%) or ischemic (17%) cardiomyopathy and to other various causes (33%). Before implantation, mean ejection fraction was 14% ± 4%, 7 (54%) patients had previous cardiac surgery, 4 (31%) were on mechanical ventilation, and 3 (23%) patients were on dialysis. The mean duration of TAH support was 46 ± 40 days. Three (23%) patients died while on support after a mean of 15 days. Actuarial survival on support was 77% ± 12% at 30 days after implantation. Complications on support included stroke (n = 1, 8%), acute respiratory distress syndrome requiring prolonged intubation (n = 5, 38%) and acute renal failure requiring temporary dialysis (n = 5, 38%). Ten (77%) patients survived to be transplanted after a mean of 52 ± 42 days of support. Actuarial survival rates after transplant were 67% ± 16% at 1 month and 56% ± 17% at 1 year after transplantation. The TAH provides an alternative with low incidence of neurologic events in extremely fragile and complex patients waiting for heart transplantation. Complex and unusual anatomic conditions explained the current use of TAH.

Infections in Patients with a Total Artificial Heart Are Common but Rarely Fatal.

Patients who received a total artificial heart (TAH) at Virginia Commonwealth University (VCU) between January 1, 2010 and December 31, 2011 were identified from the VCU Mechanical Circulatory Support Clinical Database. Retrospective data extraction from the medical records was performed from the time of TAH implantation until heart transplantation or death. Infections were classified as confirmed or suspected. Twenty-seven men and five women, mean age 49.5 years (range 24-68 years) received a TAH. The mean duration of TAH support was 225 days (range 1-1,334 days). Of the 32 patients, 4 (12.5%) died and 28 (87.5 %) underwent heart transplantation. Causes of death were pneumonia (n = 1), TAH malfunction (n = 1), refractory cardiogenic shock (n = 1), and respiratory failure (n = 1). Seventy documented and 13 suspected infections developed in 25 patients (78%). The most common sources of infection were urinary tract (n = 26), respiratory tract (n = 18), and bloodstream (n = 11). There were five pump infections and two driveline infections. The number of infections per patient ranged from 0 to 10. Sixteen different pathogens were identified; the most common were: Klebsiella pneumoniae (n = 15), coagulase-negative Staphylococci (n = 10), Enterococcus species (n = 9), and Enterobacter species (n = 8). Mortality directly attributable to infection was infrequent.

Ethical Analysis of Withdrawing Total Artificial Heart Support

ObjectivesTo describe the characteristics of patients who undergo withdrawal of total artificial heart support and to explore the ethical aspects of withdrawing this life-sustaining treatment. Patients and MethodsWe retrospectively reviewed the medical records of all adult recipients of a total artificial heart at Mayo Clinic from the program's inception in 2007 through June 30, 2015. Management of other life-sustaining therapies, approach to end-of-life decision making, engagement of ethics and palliative care consultation, and causes of death were analyzed. ResultsOf 47 total artificial heart recipients, 14 patients or their surrogates (30%) requested withdrawal of total artificial heart support. No request was denied by treatment teams. All 14 patients were supported with at least 1 other life-sustaining therapy. Only 1 patient was able to participate in decision making. ConclusionIt is widely held to be ethically permissible to withdraw a life-sustaining treatment when the treatment no longer meets the patient's health care–related goals (ie, the burdens outweigh the benefits). These data suggest that some patients, surrogates, physicians, and other care providers believe that this principle extends to the withdrawal of total artificial heart support.