Temporary Left Ventricular Assist Device Research Articles

Early Stroke Following Durable Left Ventricular Assist Device (LVAD) Implantation: An Analysis of The Society of Thoracic Surgeons Intermacs National Database

BackgroundStroke remains a devastating complication of durable left ventricular assist device (LVAD) therapy. This study evaluated the incidence and risk factors for early stroke within 7 days following LVAD implantation investigating both traditional pre-implant and new intraoperative variables collected by The Society of Thoracic Surgeons (STS) Intermacs National Database. MethodsSTS Intermacs was queried for patients undergoing implantation of a fully magnetically levitated centrifugal LVAD between 11/25/2020 and 6/30/2023. STS Intermacs stroke definitions were used to identify patients who suffered a stroke within the first 7 postoperative days (POD). A multivariable logistic regression model was created to generate adjusted odd ratios (OR) for variables associated with early stroke. ResultsAmong 6950 patients in the study cohort, 5.9% (413/6950) developed a stroke after a median follow-up of 11 months, with 50% (205/413) of strokes occurring within 7 days after LVAD implantation. Of the strokes occurring during POD 0-7, 70% (144/205) occurred on POD 0-2. By multivariable analysis, the following factors were associated with early stroke: older age (70 vs. 50; OR 1.4, P=0.0129), white race (OR 1.5, P=0.0078), pre-implant temporary MCS bridge (temporary LVAD only: OR 1.6, ECMO only: OR 1.7, combination of both devices: OR 3.3; P=0.0001) and presence of an unremoved left atrial clot (OR 8.0, P<0.0001). ConclusionA significant proportion of strokes occur within the first 7 days following LVAD implantation, particularly within the first 2 days. In addition to pre-implant variables, we identified modifiable intraoperative factors associated with stroke that provide an opportunity for further risk mitigation and improvement in quality of care.

Comparison of Intraoperative Blood Product Use During Heart Transplantation in Patients Bridged with Impella 5.5 versus Durable Left Ventricular Assist Devices

To determine if the intraoperative transfusion requirements differ based on the mechanical circulatory device used as a bridge to heart transplantation. A single-center retrospective analysis of intraoperative transfusion requirements in all patients undergoing heart or heart/kidney transplantation between November 2018 and July 2021 who were bridged with a temporary (Impella 5.5) or durable left ventricular assist device (LVAD). A tertiary care hospital. Forty-three adult patients bridged to heart or heart/kidney transplantation with a temporary or durable LVAD between 2018 and 2021 INTERVENTIONS: Recording of baseline characteristics and intraoperative transfusion requirements, including packed red blood cells, fresh frozen plasma, cryoprecipitate, autologous blood salvage, and platelets. The difference in cardiopulmonary bypass times, intensive care unit length of stay, and the vasoactive inotrope score following transplantation were also recorded. The primary outcome was the volume of blood products transfused intraoperatively. Patients who underwent bridge to transplantation using the Impella 5.5 had statistically significant lower median transfusions of cryoprecipitate (155 mL versus 200 mL, p = 0.015), autologous blood salvage (675 mL versus 1,125 mL, p ≤ 0.01), and platelets (412 mL versus 675 mL, p ≤ 0.01). Additionally, there was a trend toward lower transfusion of intraoperative packed red blood cells (4.5 units versus 6.5 units, p = 0.29) and fresh frozen plasma (675 mL versus 800 mL, p = 0.11), but these were not statistically significant. The results suggest a reduction in certain intraoperative transfusion requirements in patients undergoing heart transplantation bridged with the Impella 5.5 versus durable left ventricular assist device.

Abstract 18247: Society for Cardiovascular Angiography and Intervention Shock Staging is Associated With Outcomes in Patients With an Impella 5.5 Temporary Left Ventricular Assist Device

Introduction: Surgically implanted microaxial ventricular assist devices (VAD) such as Impella 5.5 are increasingly used as temporary mechanical circulatory support (tMCS) in patients at risk for and with cardiogenic shock (CS). Understanding the associations between CS severity and outcomes in patients supported with Impella 5.5 may optimize patient selection and prevent futile interventions. Hypothesis: Increasingly severe Society for Cardiovascular Angiography and Intervention (SCAI) SHOCK stages in patients supported with Impella 5.5 are associated with worse outcomes. Methods: From 2019-2022, retrospective review of perioperative characteristics, SCAI SHOCK stage and outcomes in patients supported with an Impella 5.5. Results: In total, 228 Impella 5.5s were implanted in 226 patients; 28% (63) SCAI SHOCK stage A, 4% (10) stage B, 14% (31) stage C, 46% (104) stage D and 9% (20) stage E. Stage A and B patients more often had elective Impella 5.5s for tMCS-assisted interventions (cardiac surgery, PCI, VT ablation) (30%, 69/228) while stage C-E patients primarily had Impella 5.5 placement for acute MI (AMI), chronic cardiomyopathy and postcardiotomy CS (60%, 136/228) (p&lt;0.01). Death on Impella support by SCAI SHOCK stage was: A 3.2%, B 10%, C 13%, D 27%, E 37% (p&lt;0.01). The transition to durable VAD or heart transplant by SCAI SHOCK stage was: A 1.6%, B 0%, C 48%, D 35%, E 16% (p&lt;0.01). Conclusions: Patients supported with Impella 5.5s presented in varying degrees of CS as defined by SCAI SHOCK stage. Patients with AMI, chronic cardiomyopathy, and postcardiotomy CS more commonly presented in higher SCAI SHOCK stages than those who underwent planned Impella 5.5-assisted cardiac interventions. Patients in stage E at implant had the highest mortality while patients in stage C and D were more likely to be bridged to durable VAD or heart transplant.

Right ventricular adaptation to isolated temporary left ventricular support for cardiogenic shock

Abstract Background Acute right ventricular (RV) failure is a well-described, yet not completely understood, complication of durable left ventricular assist device (LVAD) implantation. Although temporary percutaneous LVAD may have a similar hemodynamic impact on the RV, evidence in this setting is minimal. Purpose This study aims to assess the acute adaptation of the RV to isolated left side support with the Impella device in cardiogenic shock (CS). Methods Consecutive patients assisted with an Impella device and monitored with a pulmonary artery catheter in two tertiary centres between September 2018 and November 2021 were included. Clinical and hemodynamic data were retrospectively recorded at the baseline and up to 72 hours after the implantation of the pLVAD and analysed. Two subgroups analysis were performed to test the chance of a different trend on the basis of baseline RV hemodynamics and of the cause of CS. Results Forty-eight consecutive patients were included; median age was 61 (51.5–70.5) years, 83.3% were male. 54.2% presented with SCAI (Society for Cardiovascular Angiography and Interventions) stage D cardiogenic shock [1], mostly due to myocardial infarction (AMI-CS 56.3%). Impella support was associated with a relevant improvement of the systemic perfusion and left ventricular (LV) loading condition (Table 1). At 24 hours, cardiac output improved from 3.4 (2.6–4.2) to 4.0 (3.0–5.5) L/min, p&amp;lt;0.01; lactate decreased from 3.2 (1.65–6.3) to 1.55 (1.25–2.35) mmol/L, p&amp;lt;0.01. An improvement of RV afterload, reflected by a mean pulmonary arterial pressure dropping from 31.5 (25–38.5) to 25.5 (22–32.5) mmHg, p&amp;lt;0.01, was associated with a trend toward an improvement of the right atrial pressure (RAP, from 15.8±7.3 to 13.3±5.9 mmHg, p=0.05) and a stability of the pulmonary artery pulsatility index (PAPi) from 1.08 (0.72–1.5) to 1.19 (0.83–1.64), p=0.11. When stratifying patients by RV hemodynamic parameters at baseline [2], a significantly more pronounced improvement of RAP, RAP/pulmonary capillary wedge pressure (PCWP) and PAPi in the first 24 and 48 hours was seen in those who had poor RV hemodynamics at the baseline (Table 2). Thus, at 24 and 48-hours no differences were detectable anymore in RV hemodynamic parameters between the subgroup with and without RV dysfunction at the baseline evaluation. When stratifying patients by CS aetiology, those with a non-ischemic cause of CS showed a trend toward progressively better parameters of RV function than patients with AMI-CS [median PAPi at 48 hours 1.55 (0.85–2.89) versus 1 (0.73–1.47) in AMI-CS, p=0.1; median RAP/PCWP at 48 hours 0.68 (0.55–0.81) versus 0.89 (0.77–0.92) in AMI-CS, p=0.01]. Conclusion In this cohort of patients with cardiogenic shock undergoing isolated LV support a significant improvement of systemic perfusion and LV loading condition was followed by a tendency towards an improvement of right ventricular function, even in patients with compromised RV hemodynamic profiles at baseline. Funding Acknowledgement Type of funding sources: None.

Simple left ventricular apical cannulation for temporary mechanical circulatory support.

Surgical management of cardiogenic shock, utilizing mechanical circulatory support, can provide a bridge to recovery, bridge to decision making and/or bridge to transplantation. Despite extracorporeal membrane oxygenation (ECMO) being a reliable, temporary form of support, intracardiac thrombosis is a devastating complication of veno-arterial ECMO. The use of a temporary left ventricular assist device (LVAD), although not immune to thrombosis, helps reduce intracardiac thrombosis, maintaining flow through the heart but importantly allowing for concurrent venting and drainage of the left ventricle. We demonstrate a technique for LV apical cannulation, as a part of a temporary LVAD circuit, aiming to prevent thrombotic complications secondary to cannula angulation.

Abstract 12782: Predicting One-Year Survival in LVAD Patients Using Different Predictive Models

Introduction: Left ventricular assist device (LVAD) support improves quality of life and survival in patients with end-stage heart failure (HF), but predicting which patients benefit most remains a challenge. The Penn Columbia Risk Score (PCR) and pretransplant risk stratification score (RSS) have predicted 1-year mortality in LVAD and transplant patients, respectively. We sought to compare the PCR and RSS in our single center’s LVAD population and evaluate additional predictors of survival at 1 year. Methods: Perioperative data were collected from 202 patients who received an LVAD (HVAD, Heartmate II, or Heartmate III) from 2014-2020. The logistic regression model assessed goodness-of-fit of the PCR and RSS in our population. The PCR model is based on age, creatinine, total bilirubin (tbili), body mass index, right ventricular dysfunction, aortic insufficiency while the RSS score is based on age, prior sternotomy, HF etiology, eGFR, tbili, and mechanical support. Logistic regression models were used to identify additional predictors of 1-year mortality. Results: In our 202 patients, the RSS was more predictive of 1-year mortality (R 2 =0.14) than PCR (R 2 =0.02). In addition to age, tbili, inotrope score, pulmonary artery pulsatility index (PAPi), right ventricular dysfunction, mechanical support (defined as intra-aortic balloon pump, ECMO, or temporary LVAD), and albumin were each associated with 1-year mortality (p &lt;0.05). A multivariate model including age, tbili, PAPi, right ventricular dysfunction, and albumin, had higher correlation with 1-year mortality than the RSS (R 2 =0.21). The addition of inotrope score and mechanical support to this model did not significantly change the association (R 2 =0.20). Discussion: In our patient population, the PCR and RSS were poorly predictive of 1-year survival showing almost no association. Our novel model showed higher association, while still being suboptimal. Further research is needed to refine which clinical characteristics will best predict success and survival in LVAD patients.

ELSO Interim Guidelines for Venoarterial Extracorporeal Membrane Oxygenation in Adult Cardiac Patients.

ELSO Interim Guidelines for Venoarterial Extracorporeal Membrane Oxygenation in Adult Cardiac Patients.

Early Outcomes of the First 200 US Patients Treated with Impella 5.5: A Novel Temporary Left Ventricular Assist Device.

To report the initial clinical experience with the Impella 5.5® with SmartAssist®, a temporary left ventricular assist device that provides up to 6.2 L/min forward flow, with recent FDA approval for up to 14 days. From October 2019 to March 2020, 200 patients at 42 US centers received the Impella 5.5 and entered into the IQ registry, a manufacturer-maintained quality database that captures limited baseline/procedural characteristics and outcomes through device explant. Post hoc subgroup analyses were conducted to assess the role of baseline and procedural characteristics on survival, defined as successful device weaning or bridge to durable therapy. Median patient age was 62 years (range, 13 to 83 years); 83.4% were male. The device was most commonly used for cardiomyopathy (45.0%), acute myocardial infarction complicated by cardiogenic shock (AMICS; 29.0%), and post cardiotomy cardiogenic shock (PCCS; 16.5%). Median duration of support was 10.0 days (range, 0.001 to 64.4 days). Through device explant, overall survival was 74.0%, with survival of 80.0%, 67.2%, 57.6%, and 94.7% in cardiomyopathy, AMICS, PCCS, and others (comprising high-risk revascularization, coronary artery bypass graft, electrophysiology/ablation, and myocarditis), respectively. Patients requiring extracorporeal membrane oxygenation and Impella support (35 patients, 17.5%) had significantly lower survival (51.4% vs 78.8%, P = 0.002). In the first 200 US patients treated with the Impella 5.5, we observed overall survival to explant of 74%. Survival outcomes were improved compared to historic rates observed with cardiogenic shock, particularly PCCS. Prospective studies assessing comparative performance of this device to conventional strategies are warranted in future.

Left Ventricular Assist Device in Patients with History of Alcohol Abuse or Substance Abuse: An INTERMACS Analysis

<h3>Purpose</h3> In order to understand the impact of history of alcohol and illicit substance abuse on outcomes after left ventricular assist device (LVAD) implantation, we analyzed the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) registry. <h3>Methods</h3> All patients entered into the INTERMACS registry who received a continuous-flow LVAD (CF-LVAD) from June 2006 to December 2017 were included. Patients who had a temporary LVAD, pulsatile-flow LVAD, right ventricular assist device (RVAD), total artificial hearts, or biventricular assist devices were excluded. The Median follow-up duration was 13.3 months (IQR 5.3-28.3). Multivariable Cox proportional hazards model was performed to compare survival in patients with history of alcohol or substance abuse with the rest of the population (control). <h3>Results</h3> There were a total of 15069 patients in the final study group with 1184 patients with history of alcohol abuse and 1139 patients with history of substance abuse. The mean age in alcohol abuse and substance abuse group were 53.3 ± 12.4 (years), and 47.6 ± 12.5 (years), while the mean age in control group was 57.8 ± 12.8 (years). The overall mortality rate during the follow-up in alcohol abuse and substance abuse group were 24.8%, and 21.0%, respectively, compared with 28.7% in control. There was no significant difference in adjusted mortality between the history of alcohol abuse group and control (HR, 0.97, 95% CI, 0.86-1.10, p = 0.62). Similarly, there was no difference between the history of substance abuse group and control (HR, 0.95, 95% CI, 0.83-1.10, p = 0.51) (Figure). <h3>Conclusion</h3> Our findings suggest that patients with history of alcohol abuse or substance abuse have similar mortality rates as control.

Treatment of Anti-Body Mediated Rejection Complicated by Cardiogenic Shock with a Temporary Left Ventricular Assist Device as a Bridge to Recovery

<h3>Introduction</h3> Anti-body mediated rejection (AMR) after cardiac transplantation is a difficult entity to diagnose and treat. Mortality rates in AMR remain high and treatment strategies vary but consist of therapies that aim to remove circulating antibodies, decrease antibody production, suppress T and B-cell responses, and inhibit complement. We report a case of AMR associated cardiogenic shock supported on Impella 5.0. <h3>Case Report</h3> : A 51-year-old man who received a cardiac transplant in 2018 was admitted for chest pain and dyspnea. Six weeks prior, he had similar symptoms with a right heart catherization (RHC) showing normal hemodynamics. Endomyocardial biopsy did not show cellular or AMR. On admission, he was found to be in cardiogenic shock SCAI stage D with severe bi-ventricular failure. RHC confirmed elevated right and left-sided filling pressures and low cardiac output (cardiac power output 0.7). Biopsy showed grade 1R cellular rejection and infiltrative quilty lesions with focal endocardial inflammation and C3d positive capillaries. He was intubated for hypoxemic respiratory failure and an Impella 5.0 was placed for left ventricular unloading and tissue perfusion in addition to milrinone and epinephrine drips. Labs were significant for new class II DSA (DQ7, DR53 immunodominant antibodies). He was treated with intravenous solumedrol, plasmapheresis, and antithymocyte globulin-rabbit (rATG, Thymoglobulin). He received multiple sessions of bortezomib infusion with plasmapheresis while supported with Impella 5.0. He improved over the following three weeks and was extubated with explant of the Impella 5.0 on day 16. His DSA's continued to decrease and graft function improved with ejection fraction up to 50% (Figure 1). He was discharged with plans for further bortezomib and plasmapheresis sessions. <h3>Summary</h3> This case demonstrates the successful treatment of cardiogenic shock precipitated by AMR with an Impella 5.0 as a bridge to recovery.

Timing of LVAD Implantation: A Case Report

Optimal timing of left ventricular assist device (LVAD) implantation in critically ill patients remains uncertain. Multiple studies have demonstrated that implantation of LVADs in hemodynamically stable patients with preserved end-organ function leads to better outcomes. Although seemingly intuitive, this concept highlights the importance of patient selection and the optimal timing of LVAD implantation in critically ill patients. A 35 year-old gentleman with a past medical history of morbid obesity and alcohol abuse presented from an outside hospital. He was initially diagnosed with a cardiomyopathy eight years prior to admission, although demonstrated recovery of his left ventricular ejection fraction (LVEF) after guideline directed medical therapy. He subsequently stopped his medications five years prior to admission and had been doing well. He initially presented to the other institution with shortness of breath and progressive dyspnea on exertion. A cardiac catheterization was performed and demonstrated nonobstructive coronary artery disease. An echocardiogram demonstrated severe biventricular failure with an estimated LVEF of 10%, severe mitral regurgitation and an elevated RVSP of 40%. An Impella 3.5 was placed and the patient was aggressively diuresed. Despite ongoing management, the patient developed multi-organ failure with a peak total bilirubin of 65.5 mg/dL and a creatinine of 4.27 mg/dL. He was transferred to our institution for advanced therapy. Given his morbid obesity and findings of progressively worsening multi-organ failure, immediate surgical intervention was deferred. With placement of an Impella 5 and continued aggressive medical management, he made daily improvement. Multiple selection committee discussions were held regarding the optimal timing of intervention on the previously healthy 35 year old gentleman. Temporary LVAD support with the Impella 5 was maintained for a total of 5 weeks while his respiratory, renal, liver and nutritional function were addressed. The patient was found with significant azotemia and anuria which ultimately improved with supportive medical care and continuous renal replacement therapy. Prior to LVAD implantation, CRRT was no longer required. A HeartMate 3 was ultimately implanted on day 42 of his hospitalization and the patient continued to make excellent progress in recovery. It is unclear what led to the patient's decline in cardiac function, although his morbid obesity, continued alcohol use and cessation of medical therapy likely all contributed. It Is impossible to determine whether earlier intervention would have changed his outcome. Regardless, this case highlights the importance of careful patient selection and multidisciplinary decision-making for timing of LVAD implantation.

Hemodynamic Evaluation of Right Ventricular Function before and after Impella 5.0 Placement for Cardiogenic Shock

Purpose Right ventricular (RV) dysfunction is a known complication following implantation of a durable left ventricular assist device (LVAD). Whether this occurs following temporary LVAD support with the Impella 5.0 is unknown. With increasing use of the Impella 5.0, knowledge of the acute hemodynamic effects on RV function after implantation are relevant for appropriate patient selection. The pulmonary artery (PA) pulsatility index or PAPi (PA systolic pressure minus PA diastolic pressure divided by right atrial pressure) is a novel hemodynamic marker associated with increased risk of RV failure after durable LVAD implantation. Whether this is true following temporary LVAD support is not known. The purpose of this study was to determine if patients with cardiogenic shock and pre-existing RV dysfunction had worsening or improvement in RV function following Impella 5.0 placement. Methods During a 5-year period ending August 2018 a total of 103 patients underwent Impella 5.0 placement for cardiogenic shock at our institution. Sixty-one of these patients had hemodynamic variables before and after implantation, 39 of which had a baseline PAPi ≤ 2, a value below which there is an increased risk for developing RV failure after durable LVAD placement. Hemodynamic variables were compared using Mann-Whitney U test. Results Median age was 56 (interquartile range (IQR) = 43 - 63) years at the time of Impella 5.0 placement. After device placement, PAPi increased to above 2 in 23 (59%) patients. Median PAPi increased from 1 (IQR = 0.75-1.34) to 2.40 (IQR = 1.28-3.20); p Conclusion In patients with biventricular dysfunction and cardiogenic shock before Impella 5.0 implantation, a majority demonstrated improvement in RV function (PAPi) as well as RAP, mPAP, and CI after temporary LVAD placement.

Abstract 12162: Changes in Renal Function Following Left Ventricular Assist Device Placement in Pediatric Patients: A PediMACS Analysis

Introduction: Renal dysfunction (RD) is prevalent among pediatric patients with advanced heart failure. Data are limited regarding changes in renal function following left ventricular assist device (LVAD) placement in this population. Hypothesis: Renal function will improve following pediatric LVAD placement, but degree and durability of improvement may vary based upon patient and device characteristics. Methods: Pediatric LVAD recipients enrolled in the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS) between September 19, 2012 and December 31, 2015 were included. The Schwartz equation was used to calculate eGFR and longitudinal changes in renal function were analyzed for the entire cohort as well as subgroups stratified by patient and device characteristics. Results: Data from 218 patients from 39 centers were analyzed. Mean age at implant was 9.2 years and total follow up time was 768 patient-months. There were 117 (54%) durable continuous flow LVADs, 60 (27%) durable pulsatile flow LVADs, and 41 (19%) temporary LVADs. The underlying diagnosis was cardiomyopathy in 162 (74%) patients and congenital heart disease in 47 (22%) patients. Baseline RD (eGFR &lt; 90 mL/min/1.73 m 2 ) was present in 140 (64%) patients. Overall, eGFR improved post-LVAD, peaking at 1 month post-implant (Figure 1). There was an inverse relationship between baseline eGFR and the degree of improvement at 1 month (mean increase in eGFR of 45 +/- 16 for patients with baseline RD vs. mean increase of 16 +/- 58 for patients with normal eGFR pre-LVAD, p=0.001). Degree of improvement in eGFR at 1 month did not appear impacted by device type, age, or diagnosis. There was a downward trend in eGFR after 1 month, although eGFR remained over baseline for patients with pre-implant RD. Conclusions: Renal function improves post-LVAD placement in pediatric patients regardless of age, diagnosis or device type, with improvement most pronounced in patients with baseline RD.

Temporary left ventricular assist device through an axillary access is a promising approach to improve outcomes in refractory cardiogenic shock patients.

Cardiogenic shock (CS) causes significant morbidity and mortality and such patients can deteriorate rapidly. Temporary left ventricular assist devices (LVADs) are a promising approach to manage these patients. The following is a case series in which patients stabilized with a temporary LVAD for CS improvement were analyzed retrospectively. Between June 2011 and January 2014, 15 patients received temporary devices through an axillary approach (mean age: 53 ± 15, 93% male). Mean survival time was 317.8 ± 359.5 days (range: 6-936 days). During support there were no major bleeding events, infectious complications at the axillary access site, upper extremity edema, or emboli. The most of the patients recovered from CS (93%) were mobilized (67%) and were extubated (73%) while on temporary device support. Median times to extubation, intensive care unit discharge, and discontinuation of inotropic medications were: 1.63, 18, and 15 days, respectively. Four patients recovered to no device support and five received a long-term LVAD, all of whom remain alive. Therefore, implantation of a temporary LVAD through an axillary approach is a promising therapy for improving outcomes in patients needing mechanical circulatory support as a bridge to recovery or a definitive LVAD.

Circulation : Clinical Summaries

<i>Circulation</i> : Clinical Summaries

Mesenchymal Precursor Cells as Adjunctive Therapy in Recipients of Contemporary Left Ventricular Assist Devices

Allogeneic mesenchymal precursor cells (MPCs) injected during left ventricular assist device (LVAD) implantation may contribute to myocardial recovery. This trial explores the safety and efficacy of this strategy. In this multicenter, double-blind, sham-procedure controlled trial, 30 patients were randomized (2:1) to intramyocardial injection of 25 million MPCs or medium during LVAD implantation. The primary safety end point was incidence of infectious myocarditis, myocardial rupture, neoplasm, hypersensitivity reaction, and immune sensitization (90 days after randomization). Key efficacy end points were functional status and ventricular function while temporarily weaned from LVAD support (90 days after randomization). Patients were followed up until transplant or 12 months after randomization, whichever came first. Mean age was 57.4 (±13.6) years, mean left ventricular ejection fraction was 18.1%, and 66.7% were destination therapy LVADs. No safety events were observed. Successful temporary LVAD weaning was achieved in 50% of MPC and 20% of control patients at 90 days (P=0.24); the posterior probability that MPCs increased the likelihood of successful weaning was 93%. At 90 days, 3 deaths (30%) occurred in control patients, and none occurred in MPC patients. Mean left ventricular ejection fraction after successful wean was 24.0% (MPC=10) and 22.5% (control=2; P=0.56). At 12 months, 30% of MPC patients and 40% of control patients were successfully temporarily weaned from LVAD support (P=0.69), and 6 deaths (30%) occurred in MPC patients. Donor-specific HLA sensitization developed in 2 MPC and 3 control patients and resolved by 12 months. In this preliminary trial, administration of MPCs appeared to be safe, and there was a potential signal of efficacy. Future studies will evaluate the potential for higher or additional doses to enhance the ability to wean LVAD recipients off support. http://www.clinicaltrials.gov. Unique identifier: NCT01442129.

Techniques for Venoarterial Extracorporeal Membrane Oxygenation Support and Conversion to Temporary Left Ventricular Assist Device

Veno-arterial ECMO is a powerful tool for resuscitating patients in refractory cardiogenic shock. However, outcomes are poor unless it is implemented correctly and converted to more long term devices in a stepwise and timely fashion. In this article we detail the steps required to guarantee the highest survival rate for these critically ill patients.

Carotid Duplex Imaging on a Patient with a Temporary Left Ventricular Assist Device

Introduction In a carotid Duplex scan, the spectral Doppler examination is used to quantify stenosis by using the peak systolic and end diastolic velocities and ratios of the systolic velocities. The carotid spectral waveform is markedly different when a patient has a temporary left ventricular assist device (LVAD) that is nonpulsatile or continuous because of the oxygenated blood being redirected from the left atrium into the femoral artery via a centrifugal pump. This continuous-flow device provides complete circulatory support, preserving organ function and allowing quick restoration of hemodynamic stability. Case Report A 23-year-old man with idiopathic dilated cardiomyopathy, end-stage congestive heart failure, and cardiogenic shock required emergent placement of a TandemHeart temporary LVAD. Carotid Duplex imaging was performed the next day as a routine examination ordered for preheart transplant evaluation. No atherosclerotic disease was noted on B-mode images; however, intermittent bubbles were visualized and appeared as high-intensity transient signals within the Doppler spectral waveform. Flow was continuous in the carotid and vertebral arteries bilaterally. Discussion Percutaneous LVAD devices are increasingly being used as a short-term “bridge to cardiac transplantation.” Vascular sonographers should be aware that peripheral arterial flow will be nonpulsatile in patients who are sustained on these continuous flow devices. If significant disease is present we will need to rely on B-mode and color images and calculation of percent area or diameter reduction instead of waveform and velocity data.

Preclinical evaluation of a biolized temporary ventricular assist device.

An external clinical temporary ventricular assist device (VAD) has been developed with the use of our universal, multipurpose cardiac prosthesis with specially designed inflow and outflow cannulas. The cannulas allow flexibility in application of the VAD, which can access the vascular system via either the atrium or ventricle for inflow, and the aorta or pulmonary artery for outflow. A high-pressure pneumatic actuator activates the pusher-plate of the VAD. The clinical drive system for this VAD has complete redundancy and automatic switching to a backup system in the event of any component failure. Six VADs were tested in calves as a temporary left VAD before clinical use and functioned well.

Initial Clinical Experience with a New Temporary Left Ventricular Assist Device

A new, simple left ventricular assist system has been developed and its use in experimental animals has been evaluated. The system achieves ventricular drainage by a transaortic valve cannula and utilizes a new centrifugal pump; the blood access is unique in requiring only a simple end-to-side synthetic graft anastomosis to the ascending aorta. Adequate pulsatility is obtained by concomitant use of an intraaortic balloon pump. This case report documents our initial clinical experience with this system in a postoperative patient with profound left ventricular failure unresponsive to all usual treatment. There was temporary recovery of left ventricular function upon decannulation after five and a half days of assist pumping. Despite the eventual death of the patient, the system functioned adequately, suggesting that it has good potential for use in a small, selected group of patients.