LVAD Implantation Research Articles

Overcoming Racial Disparities: Towards Equitable Care in Left Ventricular Assist Device Patients

<h3>Purpose</h3> Literature has reported conflicting findings on racial disparities in clinical outcomes in patients with advanced heart failure. In this study, we sought to investigate whether racial differences influence clinical outcomes after LVAD implantation. <h3>Methods</h3> We retrospectively analyzed 208 patients who underwent durable LVAD implantation at a US tertiary medical center between January 2010 and April 2020. Patients were divided into three racial groups: Caucasian (45.4%), African American (44.4%), or Other (7.9%) and compared for all-cause mortality and freedom from readmissions. <h3>Results</h3> No difference in survival was seen between the two racial groups at 1 year (P=0.36) and 3 years (P=0.59). Similarly, no difference in freedom from readmission was seen between the two groups at 1 year (P=0.468) and 3 years (P=0.521). After adjusting for relevant covariates, African American race was not a significant predictor of reduced survival at 1 year (HR, 1.88; 95% CI, 0.40-8.85; P=0.42) or 3 years (HR, 1.11; 95% CI, 0.45-2.7; P=0.83). When distinguished, Asian and Hispanic patients did not have significantly different outcomes from Black or White patients (data not shown due to small sample size). <h3>Conclusion</h3> In this single center retrospective study, African American patients had similar survival to Caucasian patients in both the short- and long-term after LVAD implantation, and that patients of all races have similar clinical outcomes following LVAD despite different preoperative clinical profiles. Optimal care in a comprehensive, multi-disciplinary cardiac center with program-wide patient assistance and risk mitigation measures may help eliminate racial disparity in clinical outcomes for LVAD patients.

Successful Recovery with Venovenous ECMO for ARDS After LVAD HeartMate 3 Implantation: A Case Report

<h3>Introduction</h3> ARDS following LVAD implantation is an unusual but devastating complication. Venovenous (VV) extracorporeal membrane oxygenation (ECMO) can be used as a salvage treatment. We report the successful use of VV ECMO for ARDS Klebsiella pneumonia following urgent LVAD Heartmate 3 implantation. <h3>Case Report</h3> A 69-year-old male with past medical history significant for ischemic cardiomyopathy, status post CABG, and with known CHF presented to the emergency department after a witnessed cardiac arrest. He was found to have a wide-complex tachycardia and his internal cardiac defibrillator discharged. He was started on intravenous lidocaine which was transitioned to amiodarone and carvedilol. An echo demonstrated an EF of 10-15% and a dilated left ventricle. Left and right heart catheterization showed a patent LIMA to LAD bypass graft and a cardiac index of 1.64 L/min/m². The patient was optimized and underwent urgent LVAD Heartmate 3 implantation (HM3, Abbott, Chicago, IL). Post-operatively he was on 20 (ppm) inhaled nitric oxide (iNO) which was weaned and he was extubated on postoperative day 2 but subsequently re-intubated on the same day due to profound hypoxemia. On post-operative day 3 the hypoxemia was refractory despite maximal ventilator support with FiO2 100%, PIP 37, PEEP 13, 20 ppm iNO. The arterial blood gas (ABG) was a pH 7.4, pO2 54, pCO2 38, HCO3 24, BE -1,and the decision was made to cannulate for VV ECMO. The patient was cannulated with a dual-lumen cannula (Avalon Elite, Getinge, Gothenburg, Sweden) in the right internal jugular vein. Respiratory cultures were positive for Klebsiella aerogenes and the patient was treated with vancomycin and cefepime. He was supported with VV ECMO for 6 days then decannulated. Two days later, a percutaneous tracheostomy was performed and he was ambulating the halls. The tracheostomy was removed after 18 days. He was discharged to a rehab facility on post-operative day 18 where he stayed for 6 days. <h3>Summary</h3> When the ventilator is at maximal settings, with minimal changes in oxygenation, VV ECMO is the next step of care for otherwise appropriate candidates. Our case demonstrates that the use of VV ECMO is a successful treatment option for a patient with refractory hypoxemia, post-cardiotomy, s/p LVAD implantation. A multi-disciplinary approach along with early initiation of these interventions can result in successful weaning of VV ECMO.

Combined Heart Transplantation and Latissimus Dorsi Myo-Cutaneous Flap as Ultima Ratio Due to Severe Osteomyelitis Following LVAD Implantation and Total Sternectomy

<h3>Introduction</h3> Infections in LVAD-patients are common and may lead to life-threatening complications. Although driveline infections are most commonly detected, development of blood stream infections related to LVAD-implantation can also pilot towards mediastinitis and osteomyelitis, thus resulting in extensive bone destruction of the sternum. <h3>Case Report</h3> A 37-year-old patient was transferred to our heart failure unit following complete sternectomy due to severe osteomyelitis, mediastinitis and a pyopericardium three years after an emergent LVAD implantation. An LVAD weaning was not possible due to immediate compromise of hemodynamics. The patient presented a thorax apertum secured in vacuum therapy and persistent wound infection with 3 MRGN positivity. Through intensified antibiotic therapy, continuous wound dressing and renewal of vacuum therapy, the infection was controlled, and a stable status achieved. After excluding contraindications for heart transplantation (HTx), the patient was accepted for a high-urgency transplantation and successfully transplanted one month later. Thereupon, the thorax was surgically reconstructed using an extended, right-sided latissimus-dorsi, myo-cutaneous flap. Relevant hemorrhage and partial repositioning of the flap was surgically approached two weeks after the initial procedure. Antibiotic treatment was continued to prevent superinfection and modified due to postoperative pneumonia and coloproctitis. The latissimus plastic showed continuous serous perfusion without inflammation, which was drained once weekly in an external clinic for two months. Echocardiography showed preserved biventricular function. Myocardial biopsies detected no higher-grade rejection as immunosuppression was established. After achieving full recovery, the patient was successfully discharged. <h3>Summary</h3> Extended and undetected osteomyelitis can rapidly lead to life-threatening mediastinitis and sepsis. Whenever inflammation parameters remain elevated, osteomyelitis should always be considered as a focus of infection on patients following LVAD-implantation. A combined heart transplantation and latissimus-dorsi plastic present a viable option for defect coverage and a possible long-term solution after extensive sternal resection in LVAD patients.

Variable Phenotypes At Initial Presentation Of Cardiac Sarcoidosis: A Comparison Of De Novo Cardiac Sarcoidosis Versus Prior Extracardiac Sarcoidosis

Background Sarcoidosis is an inflammatory granulomatous disease that can affect several organs. Cardiac involvement is increasingly prevalent. However, characteristics of patients who present de novo with cardiac sarcoidosis (CS) compared to those diagnosed with CS after prior extracardiac sarcoidosis (ECS) diagnosis have not been studied. Methods : A retrospective cohort of 253 CS patients from 2000-2020 at an urban, quaternary medical center was studied. Medical records were reviewed for initial CS presentation, management, and outcomes. Differences (two sample t-test, chi-squared test, or Fisher's exact test) between de novo CS and prior ECS groups were analyzed. Results : There were 124 (49%) de novo CS patients and 129 (51%) with prior ECS at time of CS diagnosis (Table). De novo CS patients were more likely to meet Heart Rhythm Society definite CS criteria (P<0.001) and were diagnosed and started immunosuppression for CS at a younger age (p=0.001 and p=0.003, respectively). De novo CS patients had a more advanced cardiac presentation at CS diagnosis, with lower left ventricular ejection fraction (LVEF) (p<0.001), more frequent ventricular tachycardia/fibrillation (p<0.001), heart failure (p=0.052), reduced LVEF<50% (p=0.004), and complete heart block (p=0.001). As for treatment, de novo CS patients received prednisone at a higher frequency (p<0.001) and dose (p=0.011) compared to patients with prior ECS. Steroid sparing agent (SSA) frequency was similar with mycophenolate mofetil used more commonly among de novo CS patients. During follow-up, new VT, VT ablation, LVAD implantation, and heart transplantation were more common in the de novo CS group. LVEF recovery was less common in this group while mortality was similar. Conclusions : Patients diagnosed with de novo CS were younger, with more advanced cardiac presentation and worse clinical outcomes when compared to those presenting with CS after known ECS. These findings highlight the importance of upfront consideration of CS as a cause of unexplained heart block, arrhythmia, or cardiomyopathy to ensure timely treatment and prevention of advanced heart failure. One cannot wait for a diagnosis of ECS to consider CS. Sarcoidosis is an inflammatory granulomatous disease that can affect several organs. Cardiac involvement is increasingly prevalent. However, characteristics of patients who present de novo with cardiac sarcoidosis (CS) compared to those diagnosed with CS after prior extracardiac sarcoidosis (ECS) diagnosis have not been studied. : A retrospective cohort of 253 CS patients from 2000-2020 at an urban, quaternary medical center was studied. Medical records were reviewed for initial CS presentation, management, and outcomes. Differences (two sample t-test, chi-squared test, or Fisher's exact test) between de novo CS and prior ECS groups were analyzed. : There were 124 (49%) de novo CS patients and 129 (51%) with prior ECS at time of CS diagnosis (Table). De novo CS patients were more likely to meet Heart Rhythm Society definite CS criteria (P<0.001) and were diagnosed and started immunosuppression for CS at a younger age (p=0.001 and p=0.003, respectively). De novo CS patients had a more advanced cardiac presentation at CS diagnosis, with lower left ventricular ejection fraction (LVEF) (p<0.001), more frequent ventricular tachycardia/fibrillation (p<0.001), heart failure (p=0.052), reduced LVEF<50% (p=0.004), and complete heart block (p=0.001). As for treatment, de novo CS patients received prednisone at a higher frequency (p<0.001) and dose (p=0.011) compared to patients with prior ECS. Steroid sparing agent (SSA) frequency was similar with mycophenolate mofetil used more commonly among de novo CS patients. During follow-up, new VT, VT ablation, LVAD implantation, and heart transplantation were more common in the de novo CS group. LVEF recovery was less common in this group while mortality was similar. : Patients diagnosed with de novo CS were younger, with more advanced cardiac presentation and worse clinical outcomes when compared to those presenting with CS after known ECS. These findings highlight the importance of upfront consideration of CS as a cause of unexplained heart block, arrhythmia, or cardiomyopathy to ensure timely treatment and prevention of advanced heart failure. One cannot wait for a diagnosis of ECS to consider CS.

Outcomes in Patients with a Centrifugal Flow with Full Magnetic Levitation Left Ventricular Assist Device (CF-FML LVAD) Who Did Not Receive Bridging with a Continuous Heparin Infusion (CHI) After Implantation

PurposeCompare outcomes in CF-FML LVAD patients who received a CHI after implantation until they reached a therapeutic INR on warfarin to patients who were started on warfarin only and did not receive a CHI.MethodsA retrospective analysis using chart review and the institutional LVAD database was completed on 27 patients.Results5 of the 27 patients did not receive a CHI after implantation of CF-FML LVAD (due to a medication shortage), they were started on warfarin post-operative day 1 or 2 (POD1 or POD2) for an INR goal of 2-3. CHI was initiated on the remaining patients (DOS-POD8) and PTT reached therapeutic range POD2 (DOS-POD9). 2 patients did not reach therapeutic PTT before their INR was therapeutic. The CHI patients were started on warfarin POD4 (DOS-POD14). INR was therapeutic for patients without CHI POD6 (POD5-POD11). INR was therapeutic for patients with CHI POD10 (POD2-POD31). The no CHI patients reached therapeutic INR faster and were discharged from index hospitalization sooner. The no CHI patients had similar or less adverse events (AEs) then the CHI patients (Image 1).ConclusionIn a small cohort of patients, initiation of warfarin anticoagulation without CHI was not associated with thromboembolic complications. Further work to identify populations of LVAD supported patients who need less anticoagulation post-operatively is warranted before considering practice changes. Compare outcomes in CF-FML LVAD patients who received a CHI after implantation until they reached a therapeutic INR on warfarin to patients who were started on warfarin only and did not receive a CHI. A retrospective analysis using chart review and the institutional LVAD database was completed on 27 patients. 5 of the 27 patients did not receive a CHI after implantation of CF-FML LVAD (due to a medication shortage), they were started on warfarin post-operative day 1 or 2 (POD1 or POD2) for an INR goal of 2-3. CHI was initiated on the remaining patients (DOS-POD8) and PTT reached therapeutic range POD2 (DOS-POD9). 2 patients did not reach therapeutic PTT before their INR was therapeutic. The CHI patients were started on warfarin POD4 (DOS-POD14). INR was therapeutic for patients without CHI POD6 (POD5-POD11). INR was therapeutic for patients with CHI POD10 (POD2-POD31). The no CHI patients reached therapeutic INR faster and were discharged from index hospitalization sooner. The no CHI patients had similar or less adverse events (AEs) then the CHI patients (Image 1). In a small cohort of patients, initiation of warfarin anticoagulation without CHI was not associated with thromboembolic complications. Further work to identify populations of LVAD supported patients who need less anticoagulation post-operatively is warranted before considering practice changes.

Living at Distance from the Implanting Center: Any Impact on LVAD Patients Outcome?

<h3>Purpose</h3> Implanting Centers (IC) provide higher standard of care for LVAD patients compared to other facilities. The study aimed to analyze the impact of the distance between the LVAD patient residency and IC on outcomes. <h3>Methods</h3> All patients discharged from 5 Italian Centers after LVAD implantation from 2010 to 2020 were divided into 2 groups by the distance from IC: A<100 Miles (n=175) and B>100 Miles (n=141). Patients were followed-up regularly by VAD Teams. Primary end-point was freedom from Adverse Events (AEs), a composite outcome including death and device-related complications. Secondary end-points included event rates for mortality and complications. <h3>Results</h3> Baseline clinical characteristics and indications for LVAD did not differ between the two groups (Table). Group A patients received more centrifugal flow pump (p=0.02). During a mean time of 23±18 months, Group B was more likely to receive Heart Transplantation compared to Group A (27% vs 14%, p=0.01). Freedom from AEs at 3 years was 51% and 43% for Group A and B, respectively (p=0.32), Fig A. Event-rates complications for patients on pump were similar between the two groups, as shown in Fig B. <h3>Conclusion</h3> A distance >100 Miles from IC does not represent a risk factor for worse outcomes at mid-term follow-up. Different factors (strict follow-up protocols and/or telemedicine) could justify satisfactory results independently from patient residency. The higher rate of heart transplantation in group B could be related to different allocation policies among IC.

Multicenter Italian Study on Radial Mechanically Assisted Circulatory Support (MIRAMACS): Ongoing Analyses

<h3>Purpose</h3> The Multicenter Italian study on Radial Mechanically Assisted Circulatory Support (MIRAMACS) represents the first national observational registry, gathering continuous-flow (CF) left ventricular (LVAD) and biventricular assist device (BiVAD) implantation performed in adult patients. <h3>Methods</h3> Eight participating Italian hospitals contributed pre-, peri- and long-term postoperative data on LVAD implants to the registry. Data for all implants in adult patients (>18 years of age) performed between January 2000 to December 2020 were analysed. BiVADs were excluded in this preliminary analysis. This initial report focuses on patient demographics, survival, device types, adverse events and competing outcomes. <h3>Results</h3> A total of 515 patients received a CF LVAD. The mean age of LVAD recipients was 60.2 +/- 10.5 years. The majority of patients were male (89.3%). The adopted systems were: HeartWare HVAD (n=213), HeartMate III (n=140), HeartMate II (n=89), Jarvik 2000 (n=50), Berlin Heart Incor (n=19) and other brands (n=4). In 6.6% of patients the LVAD implantation was performed by usage of less invasive surgical approaches. Mortality at 30- and 90-days was 6.1% and 11.1%, respectively. A temporary right ventricular assist device (RVAD) support was necessary in 5.1% of patients. Mean follow-up time was 54.2 +/- 17.1 months. Heart transplantation was performed in 99 patients (19.2%). Survival at 1-year, 3-years, and 5-years of bridge to transplantation (BTT) cohort was 82.1%, 60.4% and 41.8%, respectively. Survival at 1-year, 3-years, and 5-years of destination therapy (DT) cohort was 69.8%, 45.6% and 30.1%, respectively. Major infection, neurological events, major bleeding and device malfunction were reported in 143 (27.7%), 97 (18.8%), 40 (7.7%) and 36 (6.9%) patients, respectively. Full Maglev technology showed competitive results. <h3>Conclusion</h3> This first MIRAMACS report reveals frequencies and results comparable with other registries. Overall success rate of CF LVAD patients is satisfactory. Detailed prospective data collection, additional participating centres and further analyses may provide robust scientific contributions.

Surgical Specialization and Standardization of Care Improves Outcomes in Mechanical Circulatory Support: A Single Center Experience

<h3>Purpose</h3> Cardiac surgery continues to transform into areas of sub-specialization and expertise to reduce variability and have superior outcomes. We sought to analyze the impact of surgical sub-specialization and use of protocol and clinical pathways on outcomes with MCS at the time of LVAD implantation. <h3>Methods</h3> A single center retrospective analysis of long term durable MCS patients between 2004-2019 was performed. The analysis was conducted comparing management of patients before (Era 1: 2004-2011) vs. after (Era 2: 2012-2019) based on before and after introduction of MCS sub-specialization. Since 2012, multiple initiatives were introduced namely recruitment of specialized MCS/transplant surgeons, multidisciplinary team rounds, establishment of a shock team, development of clinical care pathways, electronic medical record order sets and clinical practice guidelines. <h3>Results</h3> A total of 542 patients were included. During Era 1, five cardiac surgeons implanted LVADs in 123 patients, while in Era 2, two MCS/transplant trained surgeons implanted LVADs in 419 patients. Era 2 included higher number of INTERMACS 1 and 2 profile patients (41% vs. 63%) reflecting higher-acuity patient population. With implementation of the sub-specialization services, 1-year survival improved from 70% to 90%. Median ICU stay decreased from 13 to 8 days and percent of patients discharged to home increased from 62% to 95%. Standardized protocols for management of high LDH, GI bleeding, and blood pressure management resulted in significant reduction in overall hospital length of stay. With introduction of clinical care pathways, the average time for workup from admission to LVAD implant decreased from 27.6 days to 8.5 days. <h3>Conclusion</h3> Introduction of surgical sub-specialization and standardization of care with the use of clinical pathways and protocols in managing patients with LVADs can help improve survival, reduce variability in medical care, and reduce ICU length of stay.

Treatment Results of LVAD Implantation and Heart Transplantation for Oncotherapy Induced Cardiomyopathy in Women and Men

<h3>Purpose</h3> Due to the increase of patient's survival after different types of malignancies, patient's cardiovascular morbidity during these treatments is rising in mid and long term. Heart failure is one of these entities- mainly due to the increasing complexity of chemotherapeutic substances and preexisting heart disease. <h3>Methods</h3> We retrospectively analyzed our patient's files to assess the options and outcome of HF therapies after tumor related therapy. <h3>Results</h3> Out of 450 patients treated at our institution for HF after oncological therapy 46 pts. (14 female/32 male) received advanced surgical heart failure therapy as LVAD implantation and/or and heart transplantation (HTx). The individual types of tumor and the timeline of individual therapies will be reported. Heart transplantation was considered to be possible again 5 years after tumor treatment and recurrence free oncological follow up. Surgical procedures took place during Jan 2011 and May 2021. At the time point of tumor diagnosis, women were 37,9 ± 12 years of age and developed severe heart failure 10,25 ± 4 years later. Men at time point of tumor diagnosis, were 44 ± 16 years. Terminal heart failure was diagnosed and surgically treated 7,2 ± 4 years later in men. This age related disparity is due to different carcinoma entities among men and women. 35 patients received an LVAD exclusively. 3 patients recovered from VAD. 7 patients initially received LVAD followed by subsequent HTx in 4 cases. 3 pts. still are listed for Htx. Four patients underwent primary heart transplantation. Preexisting heart failure was present in 5 % of women and 7 % of men prior to the diagnosed malignancy. 80 % of women and 72 % of men are alive. <h3>Conclusion</h3> Terminal heart failure is one the leading morbidities in oncological patients in mid and long term caused by available treatment options. Higher age and better survival make advanced HF therapies (LVAD/HTx) possible with reasonable results. Patients should be referred early to evaluate these specific options.

Reviewing Sildenafil Rates: An Evaluation of Sildenafil Prescribing Trends in LVAD Patients

<h3>Purpose</h3> There remains no clear role for sildenafil use post-LVAD, raising concerns for patient adverse events, healthcare resource utilization, and unnecessary costs. This study evaluates whether sildenafil use post-LVAD has changed over time. We hypothesize an overall decrease in trend of sildenafil prescribing given uncertainty in outcomes. <h3>Methods</h3> Patients ≥ 18 years who underwent LVAD implant from April 2009 to June 2021 and were prescribed sildenafil following implant were included. The primary outcome of the study was to evaluate the yearly prescribing trends of sildenafil following LVAD. Secondary outcomes included time to sildenafil discontinuation, pharmacy resource utilization, and cost to patients. <h3>Results</h3> 86 patient encounters were included for analysis (<b>Table 1.</b>). The data was separated into two groups: patients receiving LVAD implants 2009 to 2014 versus 2015 to present. Overall, there was an approximate 11.5% decreased trend in sildenafil prescribing from 2009 to June 2021 (<b>Figure 1.)</b>. Of 86 patients who were prescribed sildenafil, 62 discontinued before (n=24) or after discharge (n=38), 19 were still on therapy at the end of the study period, and 5 were discontinued prior to heart transplantation. Time to discontinuation was significantly lower in the 2015-2021 cohort (p<0.05). The median acquisition wholesale price, initial, and maximum dose of sildenafil were lower in patients receiving LVAD implants from 2015 to 2021. <h3>Conclusion</h3> Peak use of sildenafil occurred in 2010. Our analysis demonstrated a general decline in the prescribing trend as well as the total time patients remained on therapy over the study period.

Quality of Life Post-Sternotomy: Reassessing the Utility of Standard-of-Care Sternal Precautions

<h3>Purpose</h3> Standard sternal precautions are prescribed for six to eight weeks following median sternotomy and include measures such as avoiding >10 lb weight lifting, overhead movements, and driving. However, postoperative complications have declined in large part due to advances in sternal closure techniques from traditional wire cerclage to sternal plating. A single published report from overseas suggested that current precautions may be unnecessarily restrictive and result in increased recovery time and reduced quality of life post sternotomy. To date, there is no published US study that investigated the psychosocial outcomes following median sternotomy. We hypothesize that reduction in sternal precautions will lead to a higher quality of life without compromising sternal integrity. <h3>Methods</h3> In this single-center, prospective 1:1 randomized study, we plan to enroll 64 patients who will undergo sternotomy for open heart surgeries (excluding heart transplant and LVAD implantation) at University of Chicago Medical Center into either standard of care or self-managed precautions groups. The former group requires strict adherence to current institutional sternal precautions, while the latter group will be guided by comfort and/or pain based on self-perceived and self-assessed physical limitations. English-speaking patients between the ages of 18-70 receiving a first-time median sternotomy are eligible for enrollment. For eight weeks post discharge, a quality of life EQ5D questionnaire will be administered weekly via telephone by a medical professional who will separately verify adherence to the assigned protocols as well as document occurrence of major adverse clinical events. <h3>Endpoints</h3> The primary objective of this study is to determine whether patients in the self-managed group can achieve increased quality of life as compared to the standard sternal precautions group following median sternotomy without increase in adverse clinical events. The findings could potentially provide strong evidence for updated and uniform sternal precautions protocols that eliminate outdated restrictions and enhance overall quality of life post sternotomy.

Recurrent Pump Thromboses in an LVAD Patient with Chronic Lymphocytic Leukemia

<h3>Introduction</h3> There is limited literature regarding the management of LVAD patients with concomitant hematologic malignancies. This case report describes a patient with chronic lymphocytic leukemia (CLL) who developed recurrent pump thromboses after LVAD implantation. <h3>Case Report</h3> A 66-year-old man with a past medical history of ischemic cardiomyopathy requiring HeartWare implant, CLL, and secondary polycythemia presents with recurrent pump thromboses. After an uneventful 17 months, the patient presented with gross hematuria, elevated LDH, and high pump parameters. Chronic antithrombotic therapy (AT) was per center protocol with warfarin (goal INR 2-3, time in therapeutic range [TTR] 65%) and aspirin. Hgb levels were elevated with an average of 14.0g/dL over the prior 3 months. Upon admission, he was treated with heparin without improvement in LDH or symptoms. Therapy was then escalated to alteplase (two bolus regimen of 10mg push over 1 minute and a 1mg/min push over 20 minutes followed by an extended infusion dosed at 1mg/hr for 45 hours), with improvement in LDH, pump parameters, and no adverse events. AT was intensified at discharge (INR goal 2.5-3.0, ticagrelor added) and oncology was consulted to manage Hgb levels outpatient with therapeutic phlebotomy for a goal of <12g/dL. Patient had 2 more events of pump thromboses, 2.5 and 15 months after the first and second events, respectively - both of which responded to alteplase. Hgb was at goal after the first event but was temporarily elevated 8 months prior to third event following a course of IV iron. After the second event, AT was altered to enoxaparin 1mg/kg q12hr and aspirin, given warfarin failure (two thrombotic events with above average TTR); ticagrelor was discontinued in the event an urgent pump exchange was needed. After the third event, AT was intensified again by resuming ticagrelor. Pump exchange was deferred given improvements in LDH and resolution of symptoms. In an LVAD patient with CLL, escalating AT was insufficient. Targeting a lower Hgb level, to reduce the resistance within the pump, may be beneficial. <h3>Summary</h3> Hematologic malignancies can pose an increased risk of thrombosis despite appropriate anticoagulation, and management can be challenging in LVAD patients. More aggressive control of hemoglobin in addition to adequate anticoagulation is critical in managing these patients.

Development of Aortic Regurgitation After LVAD Implantation with Descending Thoracic Aorta Anastomosis Technique

<h3>Introduction</h3> Aortic regurgitation (AR) is a complication of LVAD support. Prevalence raises 30%. Left thoracotomy (LT) access and descending thoracic aorta anastomosis technique (DTAAT) avoid conventional sternotomy complications, especially with patients with previous coronary artery bypass grafts (CABG), those with previous sternotomies or porcelain aorta. We describe two cases of severe AR after LVAD implantation with DTAAT. <h3>Case Report</h3> First case is a 70 y-o-male with advanced heart failure (HF) due to dilated ischaemic cardiomyopathy (ICM) with previous CABG. LVEF was 25%. In June 2019, he had a HM3 (HeartMate III, St. Jude Medical) implantation by LT. The initial plan was to anastomose the outflow graft to the ascending aorta but due to calcified plaques, DTAA was done. Postoperative course included hemothorax. On discharge, there was pulsatility and patient reached high dose of vasodilators. His LVAD parameters: 5100 rpm, 3.1 Lpm, PI 6-7. After 803 days on support, in August 2021, he was admitted due to an ulcerative colitis flare-up. Natriuretic peptides were high and a transoesophageal echocardiogram (TOE) revealed a significant aortic regurgitation which is pending of a TAVR procedure. Second case is a 73 y-o-male with advanced HF due to dilated ICM with previous CABG. LVEF was 15%. In December 2019, he had a HM3 implantation by LT. Due to CABG (internal mammary artery to the descending coronary artery) near the sternum, a DTAAT was performed. Postoperative course included left hemothorax and politrasfusion. Early after, the aortic valve was closed with 5200 rpm, 4.1Lpm, PI 4-5 and echocontrast was noticed in the aortic root. Later on a thrombus was evidenced above the non coronary cusp. After 354 days on support, in December 2020, he went into pulmonary oedema. A TOE revealed a torrential AR with was successfully treated with an urgent TAVR. <h3>Summary</h3> We report two cases of AR after DTAAT in which the aetiology could be related to a minor wash out of the aortic root. DTAAT is particularly applicable for patients with a history of previous cardiac surgery and usually done in destination therapy cases because the anastomosis to the descending aorta can be hard to reach during transplantation. DTAAT should be applicable to patients with increased ventricle dimensions and if aortic valve is closed, a surveillance of thrombus formation and AR development should be advised.

Adverse Events in HVAD vs. HM3 Patients under Outpatient Bridging with Low-Molecular Weight Heparin for Subtherapeutic Anticoagulation

<h3>Purpose</h3> The standard of care in patients with durable left-ventricular assist devices combines antiplatelet with anticoagulation therapy. Current guidelines recommend use of intravenous (IV) unfractionated heparin as bridge to therapeutic INR-values in the postoperative period. However, management of subtherapeutic INR in the ambulatory setting is not yet clearly defined by guidelines. The protocol at our center proposes the use of unfractionated heparin perioperatively and low-molecular weight heparin in outpatients. Therefore, we aimed to analyse outcomes in patients with continuous-flow LVAD (CF-LVAD). <h3>Methods</h3> In this single-center retrospective trial all patients after CF-LVAD implantation at our center were included between 1/2015 and 12/2020 (n=110 patients; HVAD n=80, HM3 n=30). Patients were followed up from initial discharge after LVAD implantation until death, heart transplantation or end of the observation period (9/2021). Bridging for subtherapeutic INR (≤ 0.4 below target INR) were provided with enoxaparin in a therapeutic dose adapted to weight and renal function. Only patients with an INR > 0.4 below target INR were admitted to hospital for bridging with IV unfractionated heparin. Bleeding events leading to hospital admission, cerebrovascular events and pump thromboses were evaluated and provided in percent of study population and/or events per patient year (eppy). <h3>Results</h3> Follow-up covers a total of 214.2 patient years. Overall mortality was 18.2 %. Bleeding events occurred in 42.7 %, of which GI bleeding constituted the largest group with 21.8 % (HVAD: 0.25 eppy; HM3: 0.05 eppy). Stroke/TIA/PRIND occurred in 5.5 % of the patients (HVAD: 0.07 eppy; HM3: 0.01 eppy; in total: 0.03 eppy). Intracerebral hemorrhage (overall 0.04 eppy) occurred 6.3 times more often in HVAD patients. Pump thrombosis occurred in 8.2 % of all CF-LVAD patients and was limited to HVAD (0.13 eppy). <h3>Conclusion</h3> Current studies tend to promote the use of low molecular weight heparins, especially enoxaparin for outpatient anticoagulation bridging in case of subtherapeutic INRs. However, in most cases old generation CF-LVADs were studied. Our study includes a relevant number of HM3 devices. Overall, the adverse event rates presented herein suggest feasibility of low-molecular weight heparin bridging in patients with HM3 devices.

Pre-Operative Global Longitudinal Strain Predictive Of Long-Term Risk Of GI Bleeding In Patients Undergoing Ventricular Assist Device Placement

The relationship between Right Ventricular (RV) function and gastrointestinal bleeding (GIB) after continuous flow left ventricular assist device (CF-LVAD) implantation has been an area of focus and frequent study. Herein we sought to determine whether preoperative RV function, as assessed noninvasively using two-dimensional (2D) strain analysis is a predictor for GIB. Methods: A total of 156 patients who underwent an implantation of a CF-LVAD at University of California, San Diego were prospectively recruited and studied over an 8-year period. Invasive and noninvasive hemodynamic measures were obtained and associations with GIB were investigated. Peak longitudinal strain of the RV free wall prior to CF-LVAD implantation was assessed with 2D speckle tracking. Results: A total of 97 episodes of GIB occurred in 47 (30.1%) patients after a median follow-up of 312 days (IQR 151.0-589.5). Patients with GIB had greater basal RV diastolic dimensions (5.3±1.0 cm vs. 4.9±0.9 cm, p=0.02) and worse longitudinal strain of the RV free wall (-9.9±4.0% vs. -11.6±4.1%, p=0.01). On multivariate analysis, RV free wall longitudinal strain, basal RV diastolic dimension, severity of mitral regurgitation, left atrial volume index, history of smoking, diabetes mellitus, stroke and prior GIB were independently associated with GIB. Conclusion: Pre-operative RV free wall longitudinal strain is associated with increased risk of GIB in patients after LVAD implantation, and hence may be used independent predictor of this common and morbid complication.

Three-Dimensional CT Reconstruction for Diagnosis of LVAD Outflow Graft Twist

<h3>Introduction</h3> Third generation LVAD, HeartMate3 (HM3) are associated with favorable prognosis. A rare life-threatening adverse event is a sudden outflow graft obstruction due to a rotational twist. There is limited data regarding the natural history of this complication. <h3>Case Report</h3> A 70-year-old male with dilated cardiomyopathy was implanted with an HM3 LVAD on September 2019. Echocardiography and cardiac CT immediately following the implantation showed appropriate left ventricular (LV) unloading and normal outflow cannula flows and patency. On April 2021 the patient complained of weakness. Clinical examination was normal, but LVAD interrogation identified decline of LVAD flow. Laboratory tests revealed INR in therapeutic range and normal LDH. An echocardiography revealed impaired unloading of the LV and opening of the aortic valve. A CTA showed a large irregular filling defect sized 7cm at the proximal outflow cannula. Differential diagnosis included outflow cannula twist or thrombosis. Three-dimensional CT volume rendering demonstrated a full rotational twist of the outflow cannula. An untwist operation using a lateral thoracotomy approach identified a >270º twist of the outflow graft. The cannula was untwisted and using a fixation device, the cannula was fixed, resulting in immediate improvement of the flow rate. Repeated transient low flow events at the end of the procedure mandated a repeat CTA to confirm the adequacy of cannula untwisting. Four months following the untwist procedure, the patient is well with stable LVAD flows. <h3>Summary</h3> This is the first case of an outflow graft twist obstruction with comprehensive CTA imaging at 3 critical time points: immediately after LVAD implantation, at twist occurrence and after surgical repair. We believe that it is very important to maintain a high degree of active awareness that a sudden drop in pump flow without signs of pump thrombosis may indicate outflow graft obstruction due to a twist, which is best recognized by three-dimensional CT reconstruction of the outflow graft.

Lymphopenia at Time of Index Hospital Discharge Predicts 1-Year Mortality Post Left Ventricular Device Implant

<h3>Purpose</h3> Improved pre- and post-operative predictors of mortality following LVAD implantation remain an unmet need in the field. Pre-operative lymphopenia (absolute lymphocyte count (ALC) <1500 cells/μl) has been shown to predict mortality in a cohort of LVAD patients. We first sought to validate these findings, and then determine whether post-operative lymphopenia could also risk-stratify patients. <h3>Methods</h3> We retrospectively studied 141 patients who received LVAD therapy between December 2009 and November 2018. Absolute lymphocyte count (ALC) values were obtained prior to LVAD implantation as well as upon discharge from index hospitalization. The main outcome of interest was 1-year mortality. Survival and death groups were compared using descriptive statistics, logistic regression, and area under receiver operator curve (AUROC) analysis. <h3>Results</h3> In line with previous reports, preoperative mean (standard deviation) ALC was significantly lower in the death group (1160±580 versus 1469±743 cells/μl, p=0.02). A decrease in preoperative ALC by 1000 cells/μl was associated with a 50% increased risk of mortality at 1-year (standard error (SE)= 0.15, p = 0.02). At time of LVAD hospitalization discharge, ALC was even more associated with 1-year mortality post LVAD (844±639 versus 1620±1264 cells/μl, p=0.007). Discharge ALC predicted 1-year survival with an AUC of 0.81 (Figure). By AUROC analysis, the optimal ALC cut-point was < 920 cells/μl (Sensitivity 81%, Specificity 81%). Patients below this ALC cut-point had a 3.9-fold greater risk of 1-year mortality in logistic regression (SE = 1.6, p=0.001). This remained significant even when adjusting for age and INTERMACS stage (p=0.003). <h3>Conclusion</h3> We confirmed pre-operative lymphopenia is significantly worse in patients who succumb to death post-LVAD. Moreover, we found post-operative lymphopenia at time of discharge was also predictive of 1-year mortality. Lymphopenia may prove a useful way to risk stratify patients both pre- and post-LVAD.

Sternal Precautions After LVAD Implantation: Are We Overdoing It?

<h3>Purpose</h3> Sternal precautions after median sternotomy for left ventricular device surgery (LVAD) restricts the use of the upper body movement for 6 weeks to ensure complete bone healing. Enforcing strict sternal precautions can prolong the rehabilitative process. Variability and absence of clearly defined sternal precautions further limits physical therapist in fully engaging the patient in therapy. The purpose of this study was to evaluate a strategy of limiting sternal precautions with early use of a platform walker. <h3>Methods</h3> 168 patients underwent an LVAD implantation between January 2018 to December 2020. One hundred and thirty-one met inclusion criteria of not being intubated or on biventricular support at the end of 1 week. These patients were divided into two groups based on use of this strategy. Group W (platform walker, n=74) included patients who started ambulating with a platform walker and group NW (no platform walker, n=57) consisted of patient who started ambulating without a platform walker. <h3>Results</h3> 78% (58/74) of W group patients reported increased confidence and engagement with physical therapy vs. 51% (30/57) of NW patients (<i>p</i>< 0.05). The average distance ambulated at the end of two weeks was 152 (StD 31) for the W group vs. 111 feet (StD 46) for the NW group (p< 0.001). No sternal dehiscence was noted in either group. Two patients in the w group (3%) and one (2%) had superficial separation of the sternal incision with no signs of infection (<i>p</i>=0.70). <h3>Conclusion</h3> A strategy of limiting the duration of sternal precautions with early use of a platform walker does not increase the incidence of sternal dehiscence or wound complication and increases early mobilization, confidence, and engagement of patients after LVAD implantation in physical therapy.

Prognostic Implications of Delirium After Left Ventricular Assist Device (LVAD) Implantation: A Retrospective Study

<h3>Purpose</h3> Heart failure is a risk factor for delirium with a prevalence of up to 35%. While historically thought to be a benign disorder, delirium is now recognized as a condition prognostic for mortality and morbidity. This study investigates the impact of Post-Operative Delirium (PODe) on outcomes after LVAD implantation. <h3>Methods</h3> We reviewed all adult patients receiving LVAD as Bridge to Transplant (BT) or Destination Therapy (DT) between June 2017 and December 2020. We assessed risk factors for PODe; 1-, 6-months, and in-hospital mortality; re-intubation rate; Length of Stay (LoS); discharge disposition and readmission rates. <h3>Results</h3> In total, 360 patients (26.7% women, 75.8% African American) received durable LVAD implants for either BT (n=173, 48%) or DT (n=187, 52%). 94 patients (26.1%) developed PODe. Pre-implantation characteristics of gender, race, past medical or psychiatric conditions, INTERMACS score, and laboratory values did not differ between the two groups with and without PODe; age (55.88 vs 59.00; p=0.031) was associated with development of PODe. PODe was associated with higher 1-month (p=0.007), 6-months (p=0.004), in-hospital mortality (p<0.001), and unplanned re-intubations (p<0.001). Patients with delirium who survived their index admission were less likely to be discharged home (42% vs 60%, p=0.03). There was a clinically significant association of PODe with a longer LoS in hospital by 4.61 days and an earlier re-admission by 5.4 days. Delirium was not associated with a higher number of re-admissions. A subgroup analysis shows that the treatment of PODe with either physical or chemical restraints in the post-LVAD population is associated with higher mortality and adverse hospitalization outcomes. <h3>Conclusion</h3> In this single-center retrospective study, PODe was associated with higher mortality, adverse hospitalization outcomes, and unfavorable discharge disposition. This study highlights the need to identify and aggressively prevent and treat delirium in the LVAD surgical population, with particular emphasis on non-pharmacological strategies. Future prospective studies are needed to identify modifiable delirium risk factors as well as establish the prognostic value of delirium in this vulnerable population.

Evaluation of the Stanford Integrated Psychosocial Assessment for Transplantation on Clinical Outcomes Following Left Ventricular Assist Device Implantation

<h3>Purpose</h3> The Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT) is a validated psychosocial risk assessment tool widely used in evaluation of heart transplant candidates. We explored its usefulness and re-purposability in predicting post-operative clinical outcomes in the LVAD patient population. <h3>Methods</h3> 145 patients implanted with a durable LVAD at a US tertiary medical center between January 2010 and April 2020 were retrospectively enrolled. Patients were risk-stratified into three groups by SIPAT score based on commonly accepted thresholds of <6 as excellent (31.7%), 6-20 as good (53.8%), and >20 as acceptable/poor (14.5%). <h3>Results</h3> The enrolled patients were predominantly male (68.3%) with a mean age of 54.8 years and mean overall SIPAT score of 12.4. When defined continuously, SIPAT score was not a significant predictor for survival at 1 year (HR, 0.995; 95% CI, 0.927-1.068; P=0.897) or 3 years (HR, 0.989; 95% CI, 0.942-1.039 P=0.666). There was no significant difference in survival between patient groups of different SIPAT strata at 1 year (P=0.888) or 3 years (P=0.743) or in freedom from readmission at 3 years (P=0.389). Additionally, no differences were observed when subgroup analysis was performed by device type. <h3>Conclusion</h3> Several published studies have reported conflicting findings regarding SIPAT's applicability in the LVAD population. In this contemporary single center study, we showed that SIPAT score has no direct correlation to survival or free from readmission following LVAD implantation. Further study may help identify potential contributors (e.g., implementation of a comprehensive patient/family assistance protocol) to the observed enhanced clinical outcome and reduced disparities.