Total Artificial Heart Patients Research Articles

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.

Reversal of Total Artificial Heart Mechanical Valve Thrombosis Using Catheter-Directed Thrombolysis.

Total artificial heart is associated with increased incidence of thromboembolism, which can prove to be fatal. The presence of four metallic tilting discs increases the chances of thrombus formation and sudden obstruction of the valve in a closed position resulting in severe hemodynamic collapse. Such a condition is conventionally treated by a surgical approach for device change; however, this procedure is extremely high risk and associated with complications and poor outcomes. We describe two total artificial heart patients with sudden obstruction to the filling of the right side due to fixing of the atrioventricular valve in a closed position due to a thrombus. After a quick diagnosis by rescue transesophageal echocardiography, we successfully treated these patients with catheter-directed thrombolysis with minimal adverse outcomes. We propose a carefully weighed application of this approach in hemodynamically unstable patients too tenuous for a timely surgery and with low risk for bleeding.

Impact of extra-corporeal life support (ECLS) cannulation strategy on outcome after durable mechanical circulation support system implantation on behalf of durable MCS after ECLS Study Group.

The literature on outcomes of patients requiring durable mechanical circulatory support (MCS) after extra-corporeal life support (ECLS) is limited. The aim of this study was to investigate the impact of preoperative ECLS cannulation on postoperative outcome after durable MCS implantation. The durable MCS after ECLS registry is a multicenter retrospective study that gathered data on consecutive patients who underwent durable MCS implantation after ECLS between January 2010 and August 2018 in eleven high volume European centers. Patients who underwent the implantation of total artificial heart, pulsatile pumps, or first-generation pumps after ECLS were excluded from the analysis. The remaining patients were divided into two groups; central ECLS group (cECLS) and peripheral ECLS group (pECLS). A 1:1 propensity score analysis was performed to identify two matched groups. The outcome of these two groups was compared. A total of 531 durable MCS after ECLS were implanted during this period. The ECLS cannulation site was peripheral in 87% (n=462) and central in 13% (n=69) of the patients. After excluding pulsatile pumps and total artificial heart patients, a total of 494 patients remained (pECLS =434 patients, cECLS =60 patients). A 1:1 propensity score analysis resulted in 2 matched groups (each 55 patients) with median age of 54 years (48-60 years) in cECLS group and 54 years (43-60 years) in pECLS group. HeartWare HVAD (Medtronic, Minneapolis, MN) was implanted in the majority of the patients (cECLS =71% vs. pECLS =76%, P=0.67). All postoperative morbidities were comparable between the groups. The thirty-day, one year and long-term survival was comparable between the groups (P=0.73). The cannulation strategy of ECLS appears to have no impact on the post-operative outcome after durable MCS implantation.

International Normalized Ratio Elevation as a Marker for Clinical Change in Mechanical Circulatory Support Patients

Purpose To determine if an unexpectedly elevated international normalized ratio (INR) may be associated with symptomatic clinical change in mechanical circulatory support (MCS) patients on relatively stable doses of warfarin. We hypothesize that a significant INR rise while on consistent doses of warfarin may be a signal for current or pending declines in clinical status. Methods A retrospective review of 64 outpatient MCS recipients was performed during the period 9/2013-5/2018. Patient information regarding signs and symptoms of acute decompensation were collected. These included hospital admission for fluid overload, low-flow alarms with syncope, ventricular tachyarrhythmia with/without implantable cardiac defibrillator firing, right ventricular failure, or noted fluid overload at clinic visits necessitating diuretic increase. An INR rise to values >4.0 was compared to a concurrent incidence of changes in clinical status or need for intervention within the subsequent month after an unexplained labile INR. Results The cohort included both left ventricular assist device and total artificial heart patients. Sixty-two INR values >4.0 occurred at hospital admission or preceded a clinical event by 30 days or less. The average INR that fit these criteria was 5.0 +/- 1.3. The positive predictive value of an acute clinical change as a potential for INR elevation was 28.7% with a sensitivity of 0.54. Fifty-three instances of a herein defined decline in clinical status were not associated with elevated INR. The negative predictive value of an INR 4.0, nor in the 5,836 recorded INRs that were Conclusion An unexpected INR rise may be evidence of a worsening scenario for an MCS patient experiencing a change in clinical status.

Portable Pneumatic Driver [Freedom™ Driver] System Use for Complete Circulatory Support Allows for Discharge Home in Total Artificial Hearts: The Pivotal United States Experience

To study the safety and efficacy of the portable pneumatic driver [Freedom™ Driver] in clinically stable patients supported with a total artificial heart (TAH). This is a multi-center, non-randomized study of the Freedom™ Driver System between 2010 and 2015. Patients who had a TAH implanted and were clinically stable were enrolled then followed from the initiation of Freedom™ Driver support until transplant, 90 days post-discharge, 90 days of in-hospital Freedom™ support, or death, whichever occurred first. The criteria for study success are that 95% of study subjects maintain an average cardiac index ≥ 2.2 L/min/m2 during Freedom™ Driver support and that the overall out-of-hospital to in-hospital adverse event profiles are clinically comparable while on Freedom™ Driver support. A total of 96 subjects were enrolled from 22 institutions in the United States. Of the 96 subjects, 73 (76%) were discharged after an average of 15 ± 15 days in the hospital after Freedom™ Driver initiation (median 11 days, range 3 - 86 days). For both in-hospital and discharged subjects, the overall mean cardiac index was 3.4 ± 0.4 L/min/m2 (median 3.4 L/min/m2, range 2.5 - 4.7 L/min/m2). There were 154 adverse events, 69 (45%) while inpatient and 85 (55%) while outpatient, 39 (46%) of which required readmission. There were approximately 1.2 readmissions for each of the 73 discharged subjects, with a mean 11 days length of stay (median 5 days, range 0 - 130 days). Most common causes for readmission were anemia/hemolysis/bleeding (17.7%), alarms (11.1%), infection (11.1%), and sub-therapeutic INR (10%). The mortality rate was 2.7% within 90 days post-discharge and was not associated with device failure. This is comparable to the event rate for in-hospital subjects. No preclusion from transplant occurred through the respective study endpoint. All subjects with the Freedom™ Driver maintained a cardiac index above 2.2 L/min/m2 without preclusions from transplant and minimal death rate. The Freedom™ Driver is a safe portable pneumatic driver system for clinically stable TAH patients in both hospital and outpatient settings when used per the manufacturer's instructions.

The Burden of Total Artificial Heart Patients and Complications after Heart Transplantation

Increased perioperative risk has been observed in patients with left ventricular assist devices (LVAD) and total artificial hearts (TAH) undergoing heart transplantation with worse outcomes in TAH patients. The purpose of this study was to review perioperative transplant outcomes in TAH vs LVAD patients at a high-volume transplant center. We reviewed perioperative transplant outcomes of 46 TAH patients and 85 LVAD patients from 2010-2018. Outcomes included perioperative transfusions (units of packed red blood cells, fresh frozen plasma, platelets, cryoprecipitate), time in the operating room (OR), intensive care unit (ICU) days immediately post-transplant, freedom from return to OR for bleeding, freedom from primary graft dysfunction (PGD), and 1-year freedom from temporary dialysis. In addition, 1-year outcomes included survival, freedom from cardiac allograft vasculopathy (CAV), freedom from non-fatal major adverse cardiac events (NF-MACE: myocardial infarction, heart failure, percutaneous intervention, defibrillator/pacemaker implant, stroke), and freedom from first-year rejection (any treated rejection (ATR), acute cellular rejection (ACR), antibody-mediated rejection (AMR)). TAH patients had more perioperative blood transfusions, and had decreased freedom from return to the OR for bleeding, temporary dialysis, and NF-MACE. There were no differences between groups in the time in OR, ICU days post-transplant, and freedom from PGD, survival, CAV, and rejection. TAH patients appear to have increased perioperative post-transplant risk for some parameters though no difference in PGD or survival compared to LVAD patients. In a high volume center, there can be acceptable post-transplant outcomes in TAH patients.

Comparison of SynCardia total artificial heart and HeartWare HVAD biventricular support for management of biventricular heart failure: a systematic review and meta-analysis.

The aim of this study was to compare the outcomes of patients undergoing SynCardia total artificial heart (TAH) and biventricular HeartWare ventricular assist device (Bi-HVAD) support for biventricular heart failure (HF). Electronic search was performed to identify all relevant studies detailing patients who underwent biventricular assist device implantation using Bi-HVAD devices and those who underwent TAH placement for biventricular HF. Twelve studies including 512 patients in the TAH group versus 38 patients in the Bi-HVAD group were pooled for meta-analysis. Ischemic cardiac etiology was present in 32% (95% CI, 24-47) of TAH vs. 15% (95% CI, 4-44) of Bi-HVAD patients (P=0.21). There was a comparable incidence of stroke [TAH 11% (95% CI, 7-16) vs. Bi-HVAD 13% (95% CI, 2-51), P=0.86] and acute kidney injury [TAH 28% (95% CI, 2-89) vs. Bi-HVAD 27% (95% CI, 9-59), P=0.98]. Overall infection rate was 67% (95% CI, 47-82) in TAH and 36% (95% CI, 10-74) in Bi-HVAD (P=0.16). Driveline infections were comparable between the two groups [TAH 11% (95% CI, 6-19) vs. Bi-HVAD 8% (95% CI, 1-39), P=0.73] and although a higher incidence of mediastinitis was found in the Bi-HVAD group [TAH 4% (95% CI, 2-7) vs. Bi-HVAD 15% (95% CI, 4-45), P=0.07] there was no statistically significant difference between the groups. Postoperative bleeding was present in 42% (95% CI, 28-58) of TAH vs. 23% (95% CI, 8-52) of Bi-HVAD (P=0.22). Patients in the TAH group had shorter duration of support [TAH 71 days (95% CI, 15-127) vs. Bi-HVAD 167 days (95% CI, 116-217), P=0.01]. At the mean follow-up time of 120 days, (95% CI, 83-157) patients in both groups had similar overall mortality [TAH 36% (95% CI, 22-49) vs. Bi-HVAD 26% (95% CI, 6-46), P=0.44] including mortality on device support [TAH 26% (95% CI, 17-36) vs. Bi-HVAD 21% (95% CI, 4-37), P=0.55]. Discharge home on support was achieved in 6% (95% CI, 4-17%) of TAH patients vs. 73% (95% CI, 48-89%) of Bi-HVAD (P<0.01), and 68% (95% CI, 52-84) of TAH patients were transplanted vs. 61% (95% CI, 47-75) in the Bi-HVAD group (P=0.14). Patients on Bi-HVAD support were more likely to be able to be discharged home on support and had similar overall mortality to TAH, albeit with much longer duration of support.

TOTAL ARTIFICIAL HEART: PERFORMANCE AS A BRIDGE TO HEALTH AND SURVIVAL

The performance of Total Artificial Heart (TAH) as a bridge to transplant, survival and perceived health remains underreported. Retrospective analysis of TAH patients implanted between 1/2012 and 6/2019 at a large single center. Visual analog scale (VAS) questionnaire was used during ambulatory

Assessing Cerebrovascular Hemodynamics Using Transcranial Doppler in Patients with Mechanical Circulatory Support Devices.

Mechanical circulatory support (MCS) devices are commonly used in heart failure patients. These devices carry risk for presumably embolic and additionally hemorrhagic stroke. Alterations in blood flow play a key role in stroke pathophysiology, and we aimed to learn more about hemodynamic compromise. In this study, we used transcranial Doppler (TCD) ultrasound to define hemodynamics of commonly used nonpulsatile MCS devices, as well as pulsatile devices, with special attention to the total artificial heart (TAH). From 2/2013 through 12/2016, we prospectively enrolled patients with MCS who underwent TCD imaging. We analyzed TCD parameters, including peak systolic velocity, end-diastolic velocity, pulsatility indices (PIs), and number of high-intensity transient signals. Waveform morphologies were compared between various MCS devices. We performed 132 TCD studies in 86 MCS patients. Waveforms in patients supported by venoarterial-extracorporeal membrane oxygenation demonstrated continuous flow without clear systolic peaks with an average (±SD) PI of .43 (±.2). PIs were low in patients with continuous-flow left ventricular assist devices with a mean PI of .32 (±.13). Impella patients had morphologically distinct pulsatile waveforms and a higher mean PI of .65 (±.24). In intra-arterial balloon pump patients, mean PI was 1.01 (±.16) and diastolic upstrokes were pronounced. In TAH patients, mean middle cerebral artery velocity of 79.69 (±32.33) cm/seconds and PI of .74 (±.14) approached normal values. TCD can detect characteristic waveforms in patients supported by various MCS devices. These device-specific TCD patterns are recognizable and reproducible.

Association of Infections in Patients Supported with Left Ventricular Assist Device with Vasoplegia and Post-Cardiac Transplant Outcomes

Background LVAD-specific infections (LSI) are common in patients on LVAD support. The impact of LSI on post-heart transplant (HT) outcomes is not clear. We hypothesized that LSI are associated with higher rates of acute renal failure (ARF), rejection and mortality in the first year post-HT with perioperative vasoplegia serving as a mediating factor. Methods A retrospective analysis at our institution was conducted for all LVAD patients from 10/2012 to 9/2017 who received HT. Total artificial heart patients were excluded. LSI was defined as driveline infection, pump pocket, pump or cannula infection. Vasoplegia was considered present if the following criteria were met: epinephrine/norepinephrine ≥ 150 ng/kg/min, dopamine ≥ 10 ug/kg/min or vasopressin ≥ 4 U/hr at any time point or duration of inotropic support > 14 days with a cardiac index > 2.1 L/min/m2 and systemic vascular resistance less than 15 mmHg), or any use of methylene blue or vitamin B12 complex. The primary outcome was a composite of ARF, rejection (antibody-mediated or acute cellular rejection ≥ 2R or hemodynamic compromise), and mortality in the first year post-HT. Results A total of 105 patients were bridged to HT with LVAD therapy. Of these, 63 (60%) had evidence of an LSI pre-HT with a majority (92%) being driveline-associated. These patients were more likely to be men (85% vs 69%), have higher BSA (2.05 m2 vs 1.89 m2), and be UNOS 1A (97% vs 64%), but no differences were noted in BMI, etiology of cardiomyopathy, device type, duration on LVAD support, or medical therapy. Among patients with LSI, there was an equal distribution of gram positive and negative organisms identified and 56% were on oral antibiotics vs 41% on IV antibiotics. The incidence of vasoplegia in the overall cohort was 12% (13/105), with 16% (10/63) in the LSI group vs 7% (3/42) in the no LSI group (p=0.183). Over half of the patients (56/105) experienced a composite of ARF, rejection or death post HT, 59% (37/63) in the LSI group vs 45% (19/42) in the no LSI group (p=0.175). Similarly, there was no difference in the individual components of the composite outcomes or in the secondary outcome hospital length of stay. Conclusions In our cohort, LSI were common among LVAD patients but not associated with vasoplegia or the clinical outcome of ARF, graft rejection, or mortality in the first year post HT. This may be limited by a small sample size.

Total artificial heart implantation as a bridge to transplantation: a viable model for the future?

ABSTRACTIntroduction: Since the first total artificial heart (TAH) surgery in a human patient performed in 1969, over 1300 devices have been implanted worldwide. Patients are benefiting from increased lengths of durable support and indications have expanded beyond biventricular failure including allograft failure, severe restrictive disease, and complex congenital anomalies.Areas covered: The role of the TAH in biventricular failure, rates of successful bridge-to-transplant (BTT), and survival compared with biventricular assist devices (BiVADs) are discussed and differences between TAH and LVAD patient populations are highlighted. The device’s niche role in physiologies not amenable to single ventricle support is further described. New developments such as the 50cc Syncardia, continuous flow mechanisms (BiVACOR and Cleveland Clinic CF-TAH), and a bioprosthetic model (CARMAT) are discussed.Literature review was conducted utilizing the PubMed database selecting published research, database analyses, and case reports under ‘total artificial heart’ relevant to the paper’s aims.Expert commentary: TAH patients have high rates of successful BTT and survival on par with BiVAD-supported patients. Ongoing developments including decreased device size, continuous flow mechanisms, and use of bioprosthetic materials will ensure that the TAH will have an increasing role in advanced heart failure with increased device longevity and decreased post-implant complications.

(1287) - Managing Driveline Repairs in Total Artificial Heart Patients: A Single Center Experience

(1287) - Managing Driveline Repairs in Total Artificial Heart Patients: A Single Center Experience

Abstract WMP66: Cerebrovascular Hemodynamics of Mechanical Circulatory Support Device Patients

Background: Multiple types of mechanical circulatory support (MCS) devices are commonly used in heart failure patients. These devices carry risk for neurologic complications, specifically cardioembolic stroke. Alterations in blood flow play a role in the pathophysiology, however there is limited data regarding cerebrovascular hemodynamics in MCS patients. We used transcranial Doppler (TCD) to define hemodynamics of commonly used MCS devices. Methods: We retrospectively examined charts from 2/2013 through 6/2016 for patients with MCS who underwent TCD, and obtained the following: peak systolic,end-diastolic velocities, mean flow velocities, pulsatility indices (PI) and number of high-intensity transient signals (HITS). Waveform morphologies were compared between devices. Results: Of 1,796 TCDs studies screened, 62 TCD studies were from 32 MCS patients. Of these, 21 were on extracorporeal membrane oxygenation (ECMO), 15 had a left ventricular assist device (LVAD), 18 had total artificial heart (TAH), and 2 had intra-aortic balloon pumps (IABP). Waveforms in patients supported by ECMO demonstrated continuous flow without clear systolic peaks. The averaged mean MCA velocity was 57.57 (SD= 21.00) cm/sec and mean PI is 0.35 (0.17). LVAD averaged mean MCA velocity was 57.57 (14.38) cm/sec and mean PI of 0.45 (0.28). PIs were low in patients with continuous-flow LVADs. Impella patients had morphologically distinct pulsatile waveforms compared to other types of VADs. IABP had averaged mean velocity of 56.21 (14.78) cm/sec and mean PI of 0.77 (0.15). These waveforms demonstrated pronounced diastolic upstrokes not present in other devices. In TAH patients, mean MCA velocity was 73.69 (33.00) cm/sec and PI of 0.86 (0.40). Emboli detection was performed in 46 studies, and HITS were detected in 29 (63%). Of these 15 (51%) were administered 100% oxygen which suppressed &gt;50% HITS in 10 (67%) patients. Conclusion: Patients supported by MCS devices produce unique and characteristic waveforms on TCD studies. Further studies will describe normative values in this special population. HITS were not universally present and intermittently suppressible by oxygen, suggesting some may be gaseous in nature. Risk of stroke in patients with MCS and HITS is under study.

(786) - Desensitization in Total Artificial Heart Patients

(786) - Desensitization in Total Artificial Heart Patients

Multi-Targeted Antithrombotic Therapy for Total Artificial Heart Device Patients

To prevent thrombotic or bleeding events in patients receiving a total artificial heart (TAH), agents have been used to avoid adverse events. The purpose of this article is to outline the adoption and results of a multi-targeted antithrombotic clinical procedure guideline (CPG) for TAH patients. Based on literature review of TAH anticoagulation and multiple case series, a CPG was designed to prescribe the use of multiple pharmacological agents. Total blood loss, Thromboelastograph® (TEG), and platelet light-transmission aggregometry (LTA) measurements were conducted on 13 TAH patients during the first 2 weeks of support in our institution. Target values and actual medians for postimplant days 1, 3, 7, and 14 were calculated for kaolinheparinase TEG, kaolin TEG, LTA, and estimated blood loss. Protocol guidelines were followed and anticoagulation management reduced bleeding and prevented thrombus formation as well as thromboembolic events in TAH patients postimplantation. The patients in this study were susceptible to a variety of possible complications such as mechanical device issues, thrombotic events, infection, and bleeding. Among them all it was clear that patients were at most risk for bleeding, particularly on postoperative days 1 through 3. However, bleeding was reduced into postoperative days 3 and 7, indicating that acceptable hemostasis was achieved with the anticoagulation protocol. The multidisciplinary, multi-targeted anticoagulation clinical procedure guideline was successful to maintain adequate antithrombotic therapy for TAH patients.

Manifestations of Atrial Tamponade in a Patient Implanted with SynCardia Total Artificial Heart

&#x0D; &#x0D; &#x0D; &#x0D; &#x0D; Implantation rates of the SynCardia Total Artificial Heart (TAH) system is growing owing to the increasing incidence of biventricular heart failure and the limited number of transplantable hearts. Among the complications associated with the device, atrial tamponade is an emergent condition that requires immediate attention. Atrial tamponade occurs when increasing pericardial hemorrhage leads to atrial compression that produces tamponade physiology and compromises cardiac output. Unfortunately to our knowledge, information concerning the early manifestations of tamponade in TAH patients is extremely scarce. Previous reports have focused on decreased cardiac output as an indicator of tamponade. However, other presentations including pulmonary decompensation are largely undescribed. This case provides a valuable account of the early manifestations of atrial tamponade observed prior to diminished cardiac output.&#x0D; &#x0D; &#x0D; &#x0D; &#x0D;

(568) - Left Ventricular Assist Devices vs. the Total Artificial Heart: Which Causes More Cerebrovascular Accidents?

(568) - Left Ventricular Assist Devices vs. the Total Artificial Heart: Which Causes More Cerebrovascular Accidents?

Percutaneous dilatational tracheostomy following total artificial heart implantation.

Coagulation disorders and an immune-altered state are common among total artificial heart patients. In this context, we sought to evaluate the safety of percutaneous dilatational tracheostomy in cases of prolonged need for mechanical ventilatory support. We retrospectively analysed the charts of 11 total artificial heart patients who received percutaneous dilatational tracheostomy. We focused on early and late complications. We observed no major complications and no procedure-related deaths. Early minor complications included venous oozing (45.4%) and one case of local infection. Late complications, including subglottic stenosis, stomal infection or infections of the lower respiratory tract, were not observed. In conclusion, percutaneous dilatational tracheostomy in total artificial heart patients is safe. Considering the well-known benefits of early tracheotomy over prolonged translaryngeal intubation, we advocate early timing of therapy in cases of prolonged mechanical ventilation.

Neuron-specific enolase correlates to laboratory markers of haemolysis in patients on long-term circulatory support.

Neuron-specific enolase (NSE) is used as a diagnostic tool in neuropathies, cerebral diseases or traumata and for some tumours. Furthermore, it is also expressed by erythrocytes and platelets and has been linked to haemolysis ex vivo as a laboratory issue. Chronic haemolysis is frequently associated with mechanical circulatory support by ventricular assist device (VAD) or total artificial heart (TAH). Therefore, we compared NSE with indicators of haemolysis in VAD and TAH patients. We included 599 data sets of 97 patients who underwent VAD or TAH implantation. NSE, haptoglobin (HAPT), haemopexin (HPX), free haemoglobin (frHB), lactate dehydrogenase activity (LDH), platelet counts and total bilirubin (TBIL) in plasma were analysed. Further, all major cerebral events were assessed. NSE correlated to frHB (rs = 0.553) and to LDH (rs = 0.695). An inverse correlation was found with HAPT (rs = -0.484) and HPX (rs = -0.398). Thirty-two patients suffered neurological events. Within the time frame of 1 day before to 4 days after a neurological event, correlations of NSE to HAPT (rs = -0.540) and HPX (rs = -0.611) in negative and to frHB (rs = 0.757), LDH (rs = 0.862) and TBIL (rs = 0.549) in positive direction were established (all P < 0.05). Furthermore, haemolysis was graded into three groups for severe, moderate or no or only slight haemolysis. NSE values differed correspondingly between these groups (P < 0.001). NSE correlates to laboratory parameters indicative of haemolysis in VAD and TAH patients. Our data suggest an influence of intravascular haemolysis on NSE. Therefore, the parameter should be used with caution when it is used to assess cerebral damage.