Treatment Of Advanced Heart Failure Research Articles

Evaluation of relationship between interlead electrical delay time and reverse remodeling of left ventricle in patients with quadripolar cardiac resynchronization therapy for long-term follow-up

Abstract Background Cardiac resynchronization therapy (CRT) has undoubtedly shown a high role in the treatment of advanced heart failure (HF). The effectiveness of CRT is individual and variable in each case. It is associated with the functional and structural features of heart as well as the dynamics of these features over time. Despite the quadripolar left ventricle (LV) lead widespread use, the problem of low response to CRT in the early and long-term remains actual. The search for predictors of the CRT response is an important scientific and practical issue. Purpose To determine the relationship between the interlead electrical delay time and the CRT response during 24 month postoperative period. Materials and methods We evaluated the clinical status, the quality of life and echocardiographic response of 37 patients with HF treated for 2 years with quadripolar LV lead CRT devices implanted according to guidelines: 25 males/12 females with age 62±10 years, 25 pts with history of ischemic cardiac disease, LVEF 26±7%; QRS duration 184±31 ms. The response to CRT was defined as 15% decrease of LV end-systolic volume (ESV). Interlead electrical delay time (EDT) was calculated automatically during CRT implantation, and subsequent 3–6-12–18–24 month follow-up. Results The dynamic changes EDT and ESV were assessed for 24 months after CRT. There was a significantly higher average percentage of decrease of ESV in patients (n=18), in whom the stimulation of the LV lead was carried out from a pole having a maximum EDT, in 3 months (12±8% versus 10±6% p=0.021) and in 6 months (23±9% versus 18±9% p=0.003) after CRT. That was the dynamic of reverse remodeling is significantly higher in such patients for the first 6 months. Using logistic regression, it was shown that the relative decrease EDT in the first 3 months after CRT can be a predictor of outcomes in18 and 24 months after CRT with an accuracy of 71% and 77%, respectively. The greater the relative decrease EDT between 0 and 3 months, the greater the probability of a respond in 18 and 24 months after CRT. The cut-off threshold for determining the outcomes in 18 months was 18% on the balance of specificity and sensitivity equal to 80% and in 24 months was 15% on the balance of specificity and sensitivity equal to 90%. There were no differences between the HF etiology (ischemic/ non-ischemic) and baseline rhythm. Conclusion The relationship between EDT and LV reverse remodeling have been investigated for 24 months. The rate of reverse remodeling is higher in patients in whom the stimulation of the LV lead was carried out from a pole having a maximum EDT. Relative decrease EDT in early period after CRT may be a predictor of the CRT outcomes in longtime period. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Russian Science Foundation

Implantable ventricular assistance systems (VAD) as a bridge to transplant or as 'destination therapy'.

Heart failure is a complex clinical syndrome associated with a high mortality and morbidity rate. Despite the extensive pharmacological armamentarium, a non-negligible percentage of patients develop advanced heart failure and require further therapies. In these circumstances, heart transplantation remains the treatment of choice, but the limited number of donors and the reduction of potential candidates have made necessary to develop new technologies. Since the 1980s, left ventricular assist devices (LVADs) have been introduced and have completely revolutionized the landscape of advanced heart failure treatments. This article has identified the categories of patients who can benefit from the implantation of an LVAD and summarized the new classifications. In addition, the main LVADs are described, analysing the results of the main clinical studies, with particular reference to adverse events. Although there is no perfect LVAD, a multidisciplinary team approach, dedicated to the treatment of advanced heart failure, can guide the choices on the best device to implant, in order to minimize complications and improve the patient’s quality of life.

Stem cell therapy in patients with nonischemic heart failure

Abstract Funding Acknowledgements None Background Advanced chronic heart failure, characterized by a functional NYHA class III/IV, low LVEF, elevated B-type natriuretic peptides and other criteria’s is a big epidemiological problem, and its prevalence is increasing every year. There are many treatment options for patients with chronic and advanced heart failure. Treatment options include optimal medical therapy, treatment with cardiac resynchronization devices, left ventricular assist devices, heart transplantation and from 2006 treatment with CD 34 + stem cells. Method Patient inclusion criteria for stem cell therapy include dilated cardiomyopathy with no valve disease, hypertension or substance abuse, with optimal medical management for 6 months and a decreased left ventricular ejection fraction of <40%. Patients are treated with autologous pluripotent CD 34+ cells, which are mobilized in the blood stream with a bone marrow stimulant Filgrastim, administered subcutaneously for 5 days. The patients are educated by the nurses to do administer the injections at home, and have a contact number of our department in case of side effects. On the day of the procedure, stem cells are collected using the apheresis technique and then delivered transendocardialy in the catheterisation laboratory using the system for electromechanical mapping. If no complications develop, the patients can go home the next day. Results During follow-up visits patients treated with stem cells have an increased left ventricular ejection fraction, lower levels of NT-proBNP, increased distance of 6-minute walk test and increased survival compared with the control group. They also report better physical performance. Conclusion Stem cell therapy is thus a viable option and could become a mainstream therapy for the treatment of advanced heart failure in the future.

Factors influencing health-related quality of life of patients with a left ventricular assist device: a systematic review and thematic synthesis.

Left ventricular assist devices (LVADs) are increasingly being used in the treatment of advanced heart failure. Left ventricular assist device patients frequently report improvements in health-related quality of life (HRQOL) post-implantation. However, HRQOL varies over time and between patients, which can be explained by patient-related and environmental factors, as individual studies suggest. This review aims to synthesize qualitative evidence on factors influencing HRQOL of LVAD patients. We systematically searched the databases PubMed, Scopus, PsycINFO, and CINAHL for qualitative studies on factors influencing HRQOL of patients with continuous flow LVADs. The included papers were synthesized using a thematic synthesis. The results were validated in discussion with a patient and practical implications were jointly developed. We included 11 papers and developed 7 themes that represent influencing factors for HRQOL of LVAD patients: disease experiences, emotional reactivity, heart failure and mechanical circulatory support symptoms, medical care, self-care, self-concept, and social environment. The identified themes highlight influencing factors on HRQOL. These help to explain variation in patient outcomes and to better consider the individual situation in rehabilitation. Based on the results, four strategies are proposed for promoting psychosocial outcomes: facilitate self-care, ensure social support, offer psychosocial support, and manage patient expectations.

Precipitation of Euglycemic DKA (euDKA) From the Initiation of SGLT2 Inhibitor (SGLT2i) and 0-Carb Diet Inpatient

Background: SGLT2i are increasingly prescribed for their cardiorenal benefits. Nationally renowned endocrinologists have begun to actively discuss the need for guidelines on safe use of SGLT2i inpatient, with the most common indication being treatment for advanced heart failure (HF). However, no consensus has been reached to date. While in the hospital, patients with HF who are taking SGLT2i are at an increased risk for developing euDKA due to volume depletion, critical illnesses, and restricted dietary intake. We present a case of euDKA inpatient in a man admitted for HF treated with empagliflozin (EMPA). Clinical Case: A 54-year-old man with HF and non-ischemic cardiomyopathy was admitted for decompensated HF. The patient was also newly diagnosed with T2D on admission when he presented with an elevated blood glucose (BG) of 395 mg/dL (n 62–125 mg/dL) and an elevated A1C of 13.6% (n 4–6%). Cardiologists initiated EMPA 25 mg PO daily on hospital day (HD) 2, in addition to MDI insulin. On HD3, a 0-carb diet was started for a planned FDG PET/CT scan to assess the etiology of cardiomyopathy. With an extremely limited food selection, the patient became largely fasting between HD3-6 while awaiting the PET scan, eating only eggs once a day. On HD6, patient developed chest pain and hypotension and was found to be in euDKA with AKI. Labs were notable for arterial pH 7.14 (n 7.35–7.45), CO2 12 meq/L (n 22–32 meq/L), anion gap (AG) 23 (n 4–12), BG 238 mg/dL (n 62–125 mg/dL), beta-hydroxybutyrate 7.29 mmol/L (n <0.30 mmol/L), and an acute rise in creatinine from 0.8 to 1.4 mg/dL (n 0.51–1.18 mg/dL). In addition to stopping the EMPA, the patient required treatment with IV insulin and fluids for 24 hours, with resolution of euDKA, hypovolemia, and AKI. Patient was safely discharged on HD14 on MDI insulin and metformin. Conclusion: While euDKA is increasingly recognized outpatient and perioperatively, it is under-recognized in the hospital setting. A study reported 94 patients at one center using SGLT2i inpatient experiencing no euDKA (1). However, hospitalized patients taking SGLT2i remain vulnerable to euDKA, especially with concurrent critical illnesses, volume depletion and restricted dietary intake. Zero-carb intake triggers energy production by ketosis, which greatly amplifies the risk of euDKA on SGLT2i. There are currently no guidelines for safe use of SGLT2i inpatient. When using SGLT2i inpatient, we advocate for clinicians to closely monitor patients’ symptoms and AG twice a day and consider holding SGLT2i with prolonged fasting of >24 hours to readily prevent, diagnose and treat euDKA. We recommend educating clinicians on the side effects associated with SGLT2i, developing EMR alerts, and involving endocrinologists with inpatient use of SGLT2i in high-risk patients.

Advanced heart failure

The authors of the article have analyzed the problem of advanced heart failure (AHF). Despite significant and, it is not an exaggeration to say, revolutionary achievements in clinical pharmacology, cardiac surgery and implantation arrhythmology, the number of patients with chronic heart failure (CHF) in many countries is not decreasing, and in some, for example, in Russia, it is increasing. At the same time, unfortunately, often the immediate and longterm results of the so-called optimal therapy of CHF are disappointing for both the patient and the doctor. In 2007, experts from The Heart Failure Association of the European Society of Cardiology proposed the term AHF to refer to CHF in which optimal drug therapy, as well as cardiac resynchronization therapy, are not effective, which causes repeated hospitalizations and justifies the need for the advanced treatment methods such as heart transplantation and mechanical circulatory support, and/or transition to palliative care. The agreed positions of experts from the established cardiological communities in the Old and New Worlds on the definition, diagnostic criteria and treatment of AHF have been changing over time. Unfortunately, this evolution has not yet arrived at a consensus. The lecture consistently addresses the issues of terminology, diagnosis, prognostic stratification and routing of patients with AHF, as well as short- and long-term strategies for treating these patients.

Unusual complications following left ventricular assisted device implantation: case series

BackgroundWhile left ventricular assisted devices (LVAD) have revolutionized the treatment of advanced heart failure, they are associated with a wide range of complications, including bleeding and infection which are the most common complications reported in the literature. Our case series report four unusual complications not related to gastrointestinal bleeding and infections and their management.Case presentationA 61 year old female after LVAD implantation with late onset of severe symptomatic aortic regurgitation treated by transfemoral transcatheter valve implantation (TAVI) with good long term results.A 75 year old male patient with acute pump failure secondary to cable damage, who underwent urgent pump replacement. A 49 year old female patient with a history of myoma who developed massive uterine bleeding which was treated with emergent open hysterectomy after failed gonadotropin-releasing hormone therapy replacement. A 57 year old male patient with device display failure 1 month after LVAD implantation without the ability to monitor speed, power consumption and blood flow.ConclusionsLVAD patients can be presented with a great variety of complications. Physicians should be aware of their manifestations and the management options.

Effects of Patient Distance from LVAD Implant Center on Outcomes and Quality of Life

Purpose Left Ventricular Assist Devices (LVADs) are a leading treatment for advanced heart failure. However, it is primarily major medical centers that have the resources to support an LVAD program. Many patients live far from an implant center, which makes it imperative that LVAD programs can provide quality care and support patients at a distance. The purpose of this project is to assess if distance to an implant center has an effect on patient outcomes and quality of life. We hypothesized that due to decreased accessibility to the hospital, increased distance to LVAD center would have an adverse effect on outcome and quality of life. Methods We performed a retrospective analysis of LVAD patients implanted at our institution from January 2012 to September 2020. Patients’ residential distance to LVAD center, outcome (transplant, explant, or death) and quality of life data (from EuroQol EQ-5D and KCCQ questionnaires) were analyzed. Descriptive statistics and logistic regression modeling were performed using STATA/ SE 15.1. Results 228 patients were included in the study (82% male, mean age of 57). The median distance from the hospital was 44.2 miles, with a range of 0.7 - 2458.0 miles. Distance was not associated with INTERMACS score, age at implant, race, gender, discharge destination, number of rehospitalizations within the first-year post-implant, or outcome. Distance was not associated with confidence in heart failure management, stress from health issues, or enjoyment of life (measured by EuroQol EQ-5D and KCCQ). Additionally, change in QOL scores from pre-implant to 6 months post-implant were analyzed and no significant associations were found based on distance to LVAD center. The mean distance to implant center was much higher in patients who had a stroke, however this difference was not statistically significant (94.8 mi vs 211.6 mi, p = 0.082). Conclusion Patient distance from LVAD center was not associated with outcomes including stroke and readmission or quality of life in this study. This indicates that patients do not need to reside near their LVAD center to feel supported and confident in their ability to manage their LVAD and that regional programs can provide quality care at a distance. There is a signal that of an increased risk of stroke in patients who are farther away which needs further investigation.

Severe Pulmonary Hemorrhage after Left Ventricular Assist Device Implantation - Gambling with Luck?

Purpose Left ventricular assist device (LVAD) implantation is an invasive treatment for advanced heart failure. Anticoagulation is required to prevent thrombotic events and subsequently bleeding complications are feared, most commonly gastrointestinal and intracranial. The aim of this analysis was to identify risk factors for severe pulmonary hemorrhage (SPH) after LVAD implantation. Methods We retrospectively analyzed our institutional database of 125 patients who underwent LVAD implantation between 2008 and 2019 and reviewed pre-/ intra-/ and postoperative variables, duration of intensive care unit (ICU) stay, ventilation time and hospital mortality. Results Nine out of 125 patients suffered SPH in their postoperative course. None of them had a known history of lung disease or bleeding disorder. No differences were noted between LVAD device manufacturers, intraoperative management including blood, plasma, platelet and coagulation factor transfusion or pulmonary vasodilator administration. Concomitant aortic valve replacement was statistically more common in the group with SPH (33.3% versus 7.0%, p = 0.034). Postoperatively, patients with SPH developed kidney failure (100% versus 36.7%, p = 0.001) with need for renal replacement more frequently (100% versus 24.7%, p Conclusion SPH is a rare but very serious complication after LVAD implantation and significantly worsens prognosis. Risk factors remain uncertain and may be related to parameters not included in our database, such as frequent suctioning or empiric bronchoscopy causing airway irritation.

Left Ventricular Assist Device Decommissioning, the Journey so Far - Single Centre Experience

Purpose Durable left ventricular assist device (LVAD) therapy is indicated in the treatment of advanced heart failure. Prolonged mechanical support may lead to reverse remodeling and recovery of LV function to such an extent that continued support is no longer necessary. When LV recovery occurs, the implanting center must exclude the LVAD from the circulation. Options include full surgical explant or isolation of the LVAD from the circulation without explant: ‘decommissioning’. Here we present a single-center experience of LVAD explant and decommissioning Methods We reviewed the local LVAD database (2006-2020). LVAD indication, time on support, survival, time to explant/decommission,date and indication for explant/decommission were recorded. Results 304 durable LVADs were implanted over the time reviewed. 22 patients, of which 18 male and 4 Female, underwent decommissioning/explanation of their device after a mean of 652 days . Indications for LVAD in this group were: 11 dilated cardiomyopathy, 2 familial cardiomyopathy, 7 myocarditis. In 10 patients LVAD therapy was discontinued following full myocardial recovery determined by echocardiography and right heart catheterization. In 11, partial myocardial recovery had occurred with explant/decommission expedited due to device complications. 1 experienced sudden pump failure with subsequent decommission without prior assessment of recovery. 2 patients underwent full primary surgical explant with the remaining 20 undergoing either a minimally invasive ligation of the outflow graft (n=9) or trans arterial vascular plug device occlusion (n=8). In patients undergoing less invasive procedures the driveline was cut and buried at the skin. 8 patients died following decommission/explant . 7 had partial recovery as assessed prior to intervention, with 1 patients with full recovery dying of non compliance to medical therapy. Conclusion Trans arterial vascular plug device occlusion of the LVAD outflow graft is a safe procedure in well selected patients with LV recovery, free from major procedural complications. LVAD infection is a major cause of re-intervention as following explant/decommission.

Clinical Characteristics and Outcomes of Cancer Survivors Undergoing Heart Transplantation

<h3>Purpose</h3> Heart transplantation (HT) remains the gold standard treatment for advanced heart failure (HF). Cancer survivors (CS) are at increased risk of developing HF in general and in some cases advanced HF. New consensus statements for organ transplantation in CS support the utilization of HT amongst select CS . The aim of this study was to examine clinical characteristics and outcomes of CS undergoing HT. <h3>Methods</h3> Retrospective cohort study of patients undergoing HT at a large medical center between Jan 1, 2010 and October 2020. CS were defined as those with history of malignancy other than non-melanoma skin cancer (CA) prior to HT. Baseline demographics, CA history and survival data were obtained from electronic medical records. <h3>Results</h3> 57(10.2%) CS were identified out of total of 560 HT recipients during the study period. Median age at the time of transplantation was 60 (IQR 50-65) years, and 60% of patients were male. Common pre-transplant malignancies included 13 breast CA (22.8%), 13 leukemia/lymphoma (22.8%), 8 prostate CA (14%), and 4 testicular CA (7%). 24 CS (42.1%) had received previous anthracycline therapy, and 23 CS (40.4%) had received chest radiation. Median follow-up time post-transplantation was 3.2 years (IQR 1.6-6.9 years). At the end of the study period, 50 of 57 (87.7%) CS were alive. Causes of deaths included infection (n=4), recurrent CA (n=2), and primary graft failure (n=1). Overall 9 patients (15.8%) developed 10 malignancies post HT. 4 patients had recurrence of their prior CA (2 breast ,1 colon, 1 prostate), while 6 patients developed new primary CA (prostate, renal, thyroid, lung, melanoma, lymphoma). The Kaplan Meier 5 year CA free survival was 69.8%(CI 49.8-83.1) (Figure 1) <h3>Conclusion</h3> CS appear to be at high risk of CA recurrence after HT; however infection is the leading cause of death on short term follow up. Longer follow-up is needed to understand long-term outcomes in this heterogenous group of patients to guide listing criteria, immunosuppression and CA screening.

Ventricular Assist Devices and Chronic Kidney Replacement Therapy: Technology and Outcomes.

Heart failure and kidney failure are very common conditions, precipitating and exacerbating each other. Left ventricular assist devices (LVADs) represent a relatively new technology for treatment of advanced heart failure. Kidney dysfunction, if present, makes candidate selection for LVADs challenging and contributes to multiple complications while the patients are on an LVAD support. Although kidney function generally improves after LVAD implantation, some patients develop acute and then chronic kidney disease sometimes requiring kidney replacement therapies (KRTs). Overall, chronic KRT in LVAD recipients is feasible and well tolerated, but routine technique of blood pressure monitoring should be adjusted to the continuous blood flow. Both hemodialysis and peritoneal dialysis can be used. Unique challenges for chronic KRT posed by the presence of LVAD are discussed in this review.

Abstract 17337: The Effect of Digoxin on Hemocompatibility Related Adverse Events in Patients With Durable Left Ventricular Assist Devices

Introduction: Hemocompatibility-related adverse events (HRAE) including stroke, pump thrombosis, and gastrointestinal bleeding (GIB), is a major cause of mortality in patients with continuous flow left ventricular assist devices (CF-LVAD). Digoxin (dig) is used in treatment of advanced heart failure, and has been implicated in decreasing angiogenesis via HIF-alpha/TGF inhibition. There is conflicting data regarding the effect of dig on GIB rates in patients with cf-LVADs. We investigated the association of dig use in patients implanted with CF-LVADs with HRAE with both centrifugal and axial flow devices. Methods: 12,002 patients from the INTERMACS registry implanted with cf-LVADs between 2012-2017 and were alive at 1-month were included. The event rates of HRAE at 1-yr post implant were compared in patients with or without dig use at 1-month post implant. Cox proportional hazards modeling was used to assess the independent association of dig use and HRAE. Results: There was no significant difference in age, sex, race, Cr, INR, DM, and AST in those who were prescribed vs. not prescribed dig at 1 month. On univariate analysis, dig was associated with decreased HRAE in patients with CF-LVADs at 1-year post implantation (37% vs 41%, p&lt;0.01) (Fig. 1) however this was primarily driven by decreased neurologic events. There was no association with GIB (p 0.18). On multivariate analysis, dig was not found to be an independent predictor of HRAE (HR 0.95, 95% CI 0.89-1.02, p 0.2) (Figure 2). Conclusions: Despite previous smaller studies which suggested a decreased risk of HRAE and GIB in patients with cf-LVADs, we found that dig was not an independent predictor of HRAE.

Abstract 16531: Patient With Left Ventricular Assist Device Presents in Asystole

Introduction: Left Ventricular Assist Devices (LVAD) are becoming more common in the treatment of advanced heart failure. Patients with LVADs can present with life threatening sequelae of heart failure such as sustained VT and VF. Despite frequent documented presentations with ventricular arrhythmias in this patient population, presenting with ventricular asystole in patients with LVADs has not been previously described. We present a patient with LVAD, and without ICD, who presented in ventricular asystole. Case Report: A 67-year-old male with a history of ischemic cardiomyopathy and Heartmate III LVAD implanted one year prior to presentation as destination therapy presented to our facility complaining of three weeks of fatigue, dizziness with four days of nausea and emesis. He was noted to have an electrocardiogram (ECG) demonstrating artifact associated with the LVAD, however without discernible ventricular activity (Figure 1). Multiple ECGs and cardiac monitor tracings failed to demonstrate ventricular electrical activity, concerning for fine VF versus asystole. Transthoracic Echocardiogram (TTE) demonstrated bi-ventricular standstill. The patient was started on inotropes with Dobutamine then underwent Right Heart Catheterization (RHC). Catheter-induced ventricular potentials were repeatedly recorded, favoring asystole due to complete heart block (CHB) over fine VF. The patient underwent dual chamber ICD implant to allow ventricular pacing, which resulted in hemodynamic improvement. Conclusions: There have been several case reports which mentioned patients surviving fatal arrhythmias with an LVAD. To our knowledge, none have described hemodynamic stability with asystole due to CHB as the presenting rhythm. The incidence of conduction disease and arrhythmia in this patient population may indicate necessity of ICD implantation prior to LVAD implant.

Abstract 13468: Effect of Listing Criteria on Transplant Rate and Early Outcomes in Adults With Congenital Heart Disease

Introduction: Heart failure (HF) is the leading cause of death in adults with congenital heart disease (ACHD). Heart transplant (HT) is one of the few options for the treatment of advanced HF in this growing population. In October 2018, the United Network for Organ Sharing (UNOS) implemented a change in organ allocation criteria. The effect of this change on outcomes in ACHD patients (pts) after listing and transplant has not been evaluated. Hypothesis: Change in organ allocation criteria negatively impacts outcomes in ACHD patients. Methods: Data from the Scientific Registry of Transplant Recipients in pts age &gt; 18 years old listed for HT between Oct. 2016 and 0ct. 2019 and followed through March 2020 were analyzed. Pts were grouped by diagnosis (ACHD and non-ACHD) and by the time of listing (pre- and post-change in allocation criteria). Differences in comorbidities, outcomes while listed, and 1-year Kaplan Meier survival post-HT were compared among groups. For comparison, post-change criteria (status 1-6) were equated to pre-change criteria (status 1A, 1B, 2). Results: Over 3 years, 11,931 patients were listed for HT; 459 had a primary diagnosis of ACHD. ACHD was present in 279/7942 pts listed in the 2 years pre-change and 180/3989 pts in the year post-change. ACHD pts listed post-change were less likely to have a history of cardiac surgery (88% vs. 79%, p=0.01) and more likely to have an abnormal BMI (p=0.015) than ACHD pts pre-change. Post-change, ACHD pts were listed at a higher priority status compared to pre-change ACHD. (Figure). The proportion of pts transplanted with ACHD increased slightly pre- and post-change (3.7% vs. 4.1%). There was no difference in 1-year survival in ACHD pts transplanted pre- and post-change (Figure). Conclusions: Recent changes to the UNOS organ allocation policy increased the proportion of ACHD patients transplanted with no change in early post-HT survival.

Intracoronary autologous bone marrow mononuclear cells for the compassionate treatment of advanced heart failure

Abstract Background Intracoronary delivery of autologous bone marrow-derived mononuclear cells (BMCs) has been shown to be beneficial in the treatment of patients with ischaemic (IHD) and non-ischaemic dilated cardiomyopathy (DCM). Given the results of phase II clinical trials in this population, our centre initiated the only programme to offer intracoronary BMCs to patients with advanced heart failure due to IHD or DCM in the UK. Clinical data and outcomes in these patients were maintained as part of a registry, the results of which are reported herein. Purpose To report outcomes of the first 20 patients with DCM treated at the compassionate stem cell unit. Methods A total of 45 patients with advanced heart failure (left ventricular ejection fraction (LVEF) at referral of ≤45%, New York Heart Association (NYHA) classification ≥2 and no secondary cause for the cardiomyopathy) despite optimal medical therapy (OMT) were accepted into the programme and received treatment with intracoronary BMCs, manufactured and supplied as Advanced Therapy Medicinal Products, with adjunctive granulocyte colony stimulating factor (G-CSF). All patients received 5 days of G-CSF followed by bone marrow aspiration and IC infusion of cells (∼10ml of BMCs) on Day 6. LVEF was assessed by cardiac CT. Results Of the 20 patients with DCM, 80% were male with a mean age of 64.6±10.6 years (range 45–81 years old). Baseline LVEF was 36.1%±10.6. Baseline NYHA class distributions were 70% NYHA class II (n=14), NYHA class III 25% (n=5), and NYHA class IV – 5% (n=1). All procedures were performed successfully with no procedural complications (100% radial). One year after treatment, 71.4% of people improved by 1 or more NYHA classes with 28.6% noting no change (1 year NYHA classes I (60%), II (27%) and III (13%)). No patients felt worse. A mean increase of 3.4% (±9.6%) was seen in LVEF at 1 year compared to baseline with a corresponding mean reduction in NT-pro-BNP of 18.9% (mean 1012pmol/l vs 1250pmol/l). In terms of clinical events, at 1 year all treated patients were alive, with no reported MACE events and no admissions for heart failure. Conclusion IC autologous BMC injections are a novel therapy for patients with advanced HF despite OMT. These data indicate this therapy is safe and results in significant improvement in symptoms of heart failure. An improvement in the LVEF is seen at levels which support initial findings of phase II clinical trials. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Heart Cell Foundation; Barts Heart Centre, St Bartholomew's Hospital

Outcomes Following Left Ventricular Assist Device Exchange: Focus on the Impacts of Device Infection.

Hemodynamic support with continuous-flow left ventricular assist device (CF-LVAD) therapy has proven a reliable treatment for advanced heart failure. Although modern LVADs are highly durable, device failure and infection can be resolved with surgical exchange of pump components. In this study, we investigated the incidence and outcomes of LVAD exchange with the HeartMate II and HeartWare HVAD. Data were obtained from 677 patients who underwent CF-LVAD implantation between 2005 and 2016. Patients who underwent a device exchanged were included. The primary outcomes were length of hospital stay and mortality. Of the 677 patients included in this study, 72 (10.6%) required LVAD exchange. Thirty-day and 1-year mortality rates were comparable to primary LVAD implantation: 4.3% vs. 3.49%, p = 0.727 and 20.3% vs. 20.7%, p = 0.989, respectively. Thirty-one patients (4.5%) underwent exchange with ongoing infection. Kaplan-Meier analysis indicated significant differences in survival between groups based on indication for exchange. Patients who underwent exchange after more than 150 days of active infection suffered worse postexchange survival than those who underwent exchanged earlier (P = 0.007). While exchange was required only in 10.6% of patients undergoing LVAD implantation, our results show device exchange may be executed safely and effectively, with long-term outcomes similar to primary LVAD implantation. The indication for device exchange impacts postexchange outcomes, and those exchanged with LVAD infection tend to fare worse than those exchanged for device malfunction or thrombus. Patients who are exchanged with active infection have better postoperative survival if the exchange is performed expeditiously after medical management has failed.

Living with a left ventricular assist device: psychological burden and coping: protocol for a cross-sectional and longitudinal qualitative study

IntroductionDue to technological progress and persistent shortage of donor hearts, left ventricular assist devices (LVADs) have become established in the treatment of advanced heart failure. Accordingly, more patients live with...

Safety of Ultrasound-guided Bedside Swan-ganz Catheter Insertion In Advanced Heart Failure And Cardiogenic Shock

Background Right heart catheterization (RHC) is a critical part of the diagnosis and subsequent treatment of advanced heart failure and cardiogenic shock. With increasing literature supporting mechanical ventricular assist devices, hemodynamic assessment in the acute setting is paramount to improving outcomes. This study is meant to evaluate the safety of ultrasound guided Swan-Ganz catheter (USSGC) insertion when compared to RHC done in the catheterization laboratory, with respect to major adverse events. Hypothesis USSGC insertion has a similar risk of serious adverse event when compared to RHC done in the catheterization laboratory with fluoroscopy. Methods Retrospective chart analysis was performed on patients admitted to Deborah Heart and Lung Center and undergoing RHC in a one-year period from 1/1/2019 until 12/31/2019. Clinical course was monitored following the procedure for major adverse events within 48 hours. Major adverse events related to the procedure were defined as pneumothorax requiring chest tube intervention, BARC bleeding class 3-5, pulmonary artery rupture, pulmonary infarction or venous fistula. These data were then compared between the two groups. The number of delayed days from the procedure recommendation until completion between the two groups was compared using negative binomial regression. Results Of 339 patients who underwent the procedure, 216 were performed at the bedside with USSGC, and 123 performed in the catheterization lab with fluoroscopy. There were no major adverse events in either groups. Delay to procedure was significantly lower in the USSGC group (0.02 days) compared to fluoroscopic group (1.4 days) which is a reduction of 33.6 hours in the USSGC group (P Conclusions Ultrasound guided Swan-Ganz right heart catheterization at the bedside appears to be equally as safe as fluoroscopic RHC done in the catheterization laboratory, as our analysis showed no major adverse events in both groups. Additionally, we found that USSGC insertion at the bedside was performed on average 1.4 days or 33.6 hours sooner than RHC in the catheterization lab. Further prospective studies are needed to see if rapid insertion of USSGC will lead to improved clinical outcomes in the setting of cardiogenic shock and advanced heart failure.

Correction to: Cardiac Contractility Modulation: an Important Therapy in the Treatment of Advanced Heart Failure

The article title in the original publication contains a mistake.