298 Domiciliary periodic Levosimendan infusions in advanced heart failure: a single centre experience

Abstract Aims There are several studies that describes a possible use of periodical infusions of Levosimendan in patients with advance heart failure (AHF). In these studies, Levosimendan was administered in ambulatory settings (LevoRep, LION-HEART) or during 24 h of hospital stay (LAICA) and for a maximum of 12 months. Currently there is no strong evidence about the feasibility and safety of performing the infusions in an out of hospital setting. Aim of our study was to analyse the feasibility and safety of periodical Levosimendan infusions in AHF patients, in an out of hospital setting for palliative use. Methods and results Aretrospective study was conducted from June 2016 to September 2021 on AHF patients, followed by our centre for periodic infusion of Levosimendan. All patients were previously implanted with an ICD, were ineligible for heart transplant or for ventricular assist devices. All patients on each cycle underwent a cardiological evaluation, a blood sample (complete blood count, biochemical profile, coagulation profile, and NTproBNP), and Levosimendan was administrated with a wearable infusion pump (CADD-Legacy®; Smiths Medical). The patient went home and came back the day after, to return the pump and for reassessment. We collected data on the different infusion regimen, adapted for every patient, and on adverse events during infusions. We enrolled 11 patients with AHF, 9 (82%) of which of ischaemic origin, 2 (18%) were female, median age 72 years (IQR: 64–75), 10 with NYHA class III, 1 with a NYHA class IV, for a total of 231 infusions, with a median Follow-up of 459 days (IQR 132; 783). A total dose of 6.25 mg was administered at 0.05 μg/kg/min in 24 h. In five patients the infusion was of 12.5 mg at 0.1 μg/kg/min rate in 24 h and in other three patients at 0.05 μg/kg/min in 48 h. The median interval between administrations was 21 days (IQR: 14–24.5). Mild adverse events (i.e. that did not contraindicate successive cycles) were 7 on 231 infusions (3.0%): symptomatic hypotension (four cases, 1.7%), loss of consciousness (two cases 0.9%), bleeding for vein access misplacement (one case, 0.4%). No serious adverse event such as sustained or malignant arrhythmia, allergic reaction, or need for hospital admission were recorded. Conclusions The administration of Levosimendan at home with a wearable iv pump is safe and well tolerated. This practice allows to reduce infusion costs of day hospital regime and to lengthen the time available for drug infusion, thus reducing the events caused by a too rapid infusion.

Download Full-text

Abstract 225: Frequency and Assessment of Poor Global Outcome in Patients with Left Ventricular Assist Devices

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.8.suppl_2.225 ◽

2015 ◽

Vol 8 (suppl_2) ◽

Author(s):

Timothy J Fendler ◽

Michael E Nassif ◽

Kevin F Kennedy ◽

John A Spertus ◽

Shane J LaRue ◽

...

Keyword(s):

Heart Failure ◽

Nyha Class ◽

Left Ventricular ◽

Advanced Heart Failure ◽

Ventricular Assist Devices ◽

Left Ventricular Assist Devices ◽

Ventricular Assist ◽

Bridge To Transplant ◽

Patient Reported ◽

Left Ventricular Assist

Background: Left ventricular assist device (LVAD) therapy can improve survival and quality of life in advanced heart failure (HF), but some patients may still do poorly after LVAD. Understanding the likelihood of experiencing poorer outcomes after LVAD can better inform patients and calibrate their expectations. Methods: We analyzed patients receiving LVAD therapy from January 2012 to October 2013 at a single, high-volume, high-acuity center. We defined a poor global outcome at 1 year after LVAD as the occurrence of death, disabling stroke (precluding transplant), poor patient-reported health status (most recent KCCQ at 3, 6, or 12 months < 45, corresponding to NYHA class IV), or recurrent HF (≥2 HF readmissions post-implant). We compared characteristics of those with and without poor global outcome. Results: Among 164 LVAD recipients who had 1-year outcomes data, mean age was 56, 76.7% were white, 20.9% were female, and 85.9% were INTERMACS Profile 1 or 2 (cardiogenic shock or declining despite inotropes). Poor global outcome occurred in 58 (35.4%) patients at 1 year, of whom 37 (63.8%) died, 17 (29.3%) had a most recent KCCQ score < 45, 3 (5.2%) had ≥2 HF readmissions, and 1 (1.7%) had a disabling stroke (Figure). Eight of the patients who died also experienced one of the three other poor outcomes prior to death. Patients who experienced a poor global outcome were more likely to be designated for destination therapy (46.4% vs. 23.6%, p=0.01) than bridge to transplant, have longer index admissions (median [IQR]: 39 [24, 57] days vs. 25 [18, 35] days, p=0.003), and have major GI bleeding (44.2% vs. 27.7%, p=0.056), and were less likely to undergo LVAD exchange (0% vs. 12.3%, p=0.004). Conclusion: In this large, single-center study assessing global outcome after LVAD implantation, we found that about a third of all patients had experienced a poor global outcome at 1 year. While LVAD therapy remains life-saving and the standard of care for many patients with advanced heart failure, these findings could help guide discussions with eligible patients and families. Future work should compare patients’ pre-LVAD expectations with likely outcomes and create risk models to estimate the probability of poorer outcomes for individual patients using pre-procedural factors.

Download Full-text

Mechanical Circulatory Support: Heart Failure Therapy “in Motion”

Innovations Technology and Techniques in Cardiothoracic and Vascular Surgery ◽

10.1097/imi.0000000000000305 ◽

2016 ◽

Vol 11 (5) ◽

pp. 305-314 ◽

Cited By ~ 2

Author(s):

Stephan M. Ensminger ◽

Gino Gerosa ◽

Jan F. Gummert ◽

Volkmar Falk

Keyword(s):

Heart Failure ◽

Adverse Events ◽

Continuous Flow ◽

Mechanical Circulatory Support ◽

First Generation ◽

Ventricular Assist Devices ◽

Circulatory Support ◽

Destination Therapy ◽

Flow Devices

Because the first generation of pulsatile-flow devices was primarily used to bridge the sickest patients to transplantation (bridge-to-transplant therapy), the current generation of continuous-flow ventricular assist devices qualifies for destination therapy for patients with advanced heart failure who are ineligible for transplantation. The first-generation devices were associated with frequent adverse events, limited mechanical durability, and patient discomfort due device size. In contrast, second-generation continuous-flow devices are smaller, more quiet, and durable, thus resulting in less complications and significantly improved survival rates. Heart transplantation remains an option for a limited number of patients only, and this fact has also triggered the discussion about the optimal timing for device implantation. The increasing use of continuous-flow devices has resulted in new challenges, such as adverse events during long-term support, and high hospital readmission rates. In addition, there are a number of device-related complications including mechanical problems such as device thrombosis, percutaneous driveline damage, as well as conditions such as hemolysis, infection, and cerebrovascular accidents. This review provides an overview of the evolution of mechanical circulatory support systems from bridge to transplantation to destination therapy including technological advances and clinical improvements in long-term patient survival and quality of life. In addition, recent changes in device implant strategies and current trials are reviewed and discussed. A brief glimpse into the future of mechanical circulatory support therapy will summarize the innovations that may soon enter clinical practice.

Download Full-text

MMMELD-XI Score Is Associated With Short-Term Adverse Events in Patients With Heart Failure With Preserved Ejection Fraction

Frontiers in Cardiovascular Medicine ◽

10.3389/fcvm.2021.650191 ◽

2021 ◽

Vol 8 ◽

Author(s):

Sunying Wang ◽

Yuwei Wang ◽

Manqing Luo ◽

Kaiyang Lin ◽

Xiaoxu Xie ◽

...

Keyword(s):

Heart Failure ◽

Adverse Events ◽

Ejection Fraction ◽

Risk Stratification ◽

Cardiovascular Mortality ◽

Nyha Class ◽

Preserved Ejection Fraction ◽

Short Term ◽

All Cause Mortality ◽

Discriminatory Capacity

Aim: Accumulating evidence suggests that MELD-XI score holds the ability to predict the prognosis of congestive heart failure. However, most of the evidence is based on the end-stage heart failure population; thus, we aim to explore the association between the MELD-XI score and the prognosis in heart failure with preserved ejection fraction (HFpEF).Methods: A total of 30,096 patients hospitalized for HFpEF in Fujian Provincial Hospital between January 1, 2014 and July 17, 2020 with available measures of creatinine and liver function were enrolled. The primary endpoint was 60-day in-hospital all-cause mortality. Secondary endpoints were 60-day in-hospital cardiovascular mortality and 30-day rehospitalization for heart failure.Results: A total of 222 patients died within 60 days after admission, among which 75 deaths were considered cardiogenic. And 73 patients were readmitted for heart failure within 30 days after discharge. Generally, patients with an elevated MELD-XI score tended to have more comorbidities, higher NYHA class, and higher inflammatory biomarkers levels. Meanwhile, the MELD-XI score was positively correlated with NT-pro BNP, left atrial diameter, E/e' and negatively correlated with LVEF. After adjusting for conventional risk factors, the MELD-XI score was independently associated with 60-day in-hospital all-cause mortality [hazard ratio(HR) = 1.052, 95% confidential interval (CI) 1.022–1.083, P = 0.001], 60-day in-hospital cardiovascular mortality (HR = 1.064, 95% CI 1.013–1.118, P = 0.014), and 30-day readmission for heart failure (HR = 1.061, 95% CI 1.015–1.108, P = 0.009). Furthermore, the MELD-XI score added an incremental discriminatory capacity to risk stratification models developed based on this cohort.Conclusion: The MELD-XI score was associated with short-term adverse events and provided additional discriminatory capacity to risk stratification models in patients hospitalized for HFpEF.

Download Full-text

4301Diastolic dysfunction is an independent predictor of adverse events in patients with systolic dysfunction. Insights from the MADIT-CRT trial

European Heart Journal ◽

10.1093/eurheartj/ehz745.0146 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

M Gori ◽

B Claggett ◽

A M Shah ◽

M Senni ◽

I Goldenberg ◽

...

Keyword(s):

Heart Failure ◽

Adverse Events ◽

Cox Regression ◽

Independent Predictor ◽

Nyha Class ◽

Systolic Dysfunction ◽

Classification And Regression Tree ◽

Cardiac Resynchronization ◽

Venous Flow ◽

Cart Analysis

Abstract Background Diastolic dysfunction (DD) is common in patients with heart failure with reduced ejection fraction (HFrEF). However, its prognostic relevance in HFrEF, on top of conventional risk factors including natriuretic peptides, is unknown Purpose To show the prognostic contribution of DD in HFrEF Methods We analyzed 1155 baseline echocardiograms (63% of all available exams) in the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) study, comprising HFrEF patients with LVEF≤30%, QRS duration ≥130 ms, and NYHA class I/II. We classified DD according to ASE 2016 classification, based on transmitral Doppler velocities, mitral annular Tissue Doppler velocities, pulmonary venous flow velocities, and left atrial volumes. Using Cox regression and C-statistics we assessed the independent prognostic value of DD for nonfatal HF or death. We also evaluated CART (Classification And Regression Tree) analysis Results Patients were 64±11 years-old, 24% females, and mean LVEF was 24±5%. While 45% had impaired relaxation, 33% had pseudo-normal filling, 12% restrictive patter, 6% had indeterminate diastolic function, and 4% were not classifiable due to missing data. During a mean follow-up of 2.1±1.0 years, there were 233 adverse events. After multiple adjustment, compared to patients with impaired relaxation, those with pseudo-normal and restrictive filling had greater risk of HF/death (respectively HR 1.76, 95% CI 1.16–2.66, p=0.007; HR 2.70, 95% CI 1.58–4.60, p<0.001), independently of assigned treatment (p-interaction 0.34). Adding DD to conventional markers of risk improved prediction (C-statistic 0.733, 95% CI 0.689–0.776 versus 0.708, 95% CI 0.663–0.753, p=0.024). Finally, at CART analysis DD was the first parameter to be considered to risk stratify patients (Figure) Risk stratification tree Conclusions DD is a strong independent predictor of death or heart failure in HFrEF patients with mild symptoms and should be considered in assessment of risk in this population

Download Full-text

HFrEF other treatment: ventricular assist devices

ESC CardioMed ◽

10.1093/med/9780198784906.003.0432 ◽

2018 ◽

pp. 1884-1889

Author(s):

Emer Joyce ◽

Randall C Starling

Keyword(s):

Heart Failure ◽

Adverse Events ◽

Continuous Flow ◽

Survival Rates ◽

Advanced Heart Failure ◽

Ventricular Assist Devices ◽

Ventricular Assist ◽

Assist Devices ◽

Heart Failure Patients ◽

Transplant Candidates

Over 30,000 ventricular assist devices (VADs) have been implanted worldwide in the past decade. Continuous-flow VAD therapy has realized greater durability and improved survival. Both axial and centrifugal flow devices are approved for the treatment of chronic and refractory advanced heart failure. Patients waiting for transplants that are ‘bridged’ and transplant-ineligible patients (destination therapy), receive VAD therapy. One-year survival rates are now approximately 80% and 70% at 2 years. The advent of continuous-flow VADs replaced volume displacement pulsatile VADs and numerous adverse events related to lack of circulatory pulsatility became recognized and prevalent as VAD therapy proliferated. Common adverse events include driveline infection, device infection, haemorrhagic and embolic stroke, bleeding, aortic insufficiency, and VAD thrombosis. Current VAD therapy requires systemic anticoagulation and antiplatelet therapy. A lack of donor hearts has resulted in prolonged and frequent VAD therapy in transplant candidates. Careful selection of VAD candidates is imperative and requires careful risk stratification. New VAD models with technological advances will enhance patient acceptance of VAD therapy and lead to further expansion in advanced heart failure patients.

Download Full-text

Early rehabilitation in cardiology – heart failure: The ERIC-HF protocol, a novel intervention to decompensated heart failure patients rehabilitation

European Journal of Cardiovascular Nursing ◽

10.1177/1474515120913806 ◽

2020 ◽

Vol 19 (7) ◽

pp. 592-599 ◽

Cited By ~ 1

Author(s):

Bruno Miguel Delgado ◽

Ivo Lopes ◽

Bárbara Gomes ◽

André Novo

Keyword(s):

Heart Failure ◽

Adverse Events ◽

Aerobic Exercise ◽

Functional Capacity ◽

Exercise Tolerance ◽

Nyha Class ◽

Training Group ◽

Decompensated Heart Failure ◽

Heart Failure Patients ◽

Training Protocol

Background: Decompensated heart failure patients are characterised by functional dependence and low exercise tolerance. Aerobic exercise can improve symptoms, functional capacity and an increase in exercise tolerance. However, the benefits of early rehabilitation have not yet been validated. Objective: To evaluate the safety and feasibility of an aerobic exercise training programme in functional capacity of decompensated heart failure patients. Methodology: A single centre, parallel, randomised controlled, open label trial, with 100 patients. The training group (TG, n=50) performed the training protocol and the control group (CG, n=50) performed the usual rehabilitation procedures. The London chest activity of daily living (LCADL) scale, the Barthel index (BI) and the 6 minute walking test (6MWT) at discharge were used to evaluate the efficacy of the protocol. Safety was measured by the existence of adverse events. Results: The mean age of the patients was 70 years, 20% were New York Heart Association (NYHA) class IV and 80% NYHA class III at admission. The major heart failure aetiology was ischaemic (35 patients) and valvular disease (25 patients). There were no significant differences between groups at baseline in terms of sociodemographic or pathophysiological characteristics. There was a statistically significant difference of 54.2 meters for the training group ( P=0.026) in the 6MWT and at LCADL 12 versus 16 ( P=0.003), but the BI did not: 96 versus 92 ( P=0.072). No major adverse events occurred. Conclusions: The training protocol demonstrated safety and efficacy, promoting functional capacity. This study elucidated about the benefits of a systematised implementation of physical exercise during the patient’s clinical stabilisation phase, which had not yet been demonstrated. Trial registration: Clinicaltrials.gov NCT03838003, URL: https://clinicaltrials.gov/ct2/show/NCT03838003 .

Download Full-text

2177Cardiac resynchronization therapy in patients greater than 75 years of age - results from the European Society of Cardiology Survey II with 11 088 patients

European Heart Journal ◽

10.1093/eurheartj/ehz748.0096 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

C Normand ◽

K Dickstein ◽

C Linde

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Adverse Events ◽

Cardiac Resynchronization Therapy ◽

European Society ◽

Nyha Class ◽

Cardiac Resynchronization ◽

Class Iii ◽

Resynchronization Therapy ◽

European Society Of Cardiology

Abstract Background Cardiac Resynchronization Therapy (CRT) reduces morbidity and mortality in selected patients with heart failure (HF) and electrical dyssynchrony. The median age for patients included in the CRT landmark trials ranged from 62–68 years, therefore limited trial evidence exists on CRT in patients ≥75 years of age. Purpose To assess similarities and differences in patient demographics and implantation practice in different age groups implanted with a CRT device. Methods Between 2015 and 2017, two European Society of Cardiology (ESC) associations, European Heath Rhythm Society and the Heart Failure Association, conducted the CRT Survey II, a survey of CRT implantations in 11,088 patients in 42 ESC member states. Results In our survey 32% of patients included were ≥75 years of age. These patients were more frequently in NYHA Class III or IV, had more comorbidity (including hypertension, atrial fibrillation, anaemia and renal dysfunction) and had significantly higher NT-pro BNP levels than younger patients. Slightly fewer patients ≥75 years of age had LBBB but all groups had the same median QRS duration. Despite substantially more patients ≥75 years of age having HF of ischaemic aetiology compared with those <65 year of age, far fewer patients in oldest age group category were implanted with a CRT-defibrillator (CRT-D) compared with those in the youngest group. CRT Survey II Patients by Age Categories Demographics Age <65 years Age 65–74 years Age ≥75 years N 3478 (32%) 4025 (36%) 3536 (32%) NYHA class III & IV 52% 59% 66%* Ischaemic HF aetiology 33% 49% 50%* Atrial fibrillation 17% 27% 33* NT proBNP (pg/ml, median, IQR) 1651 (670, 3811) 2319 (1070, 5169) 3510 (1647, 7631)* CRT-D 81% 76% 52%* Peri-procedural complications 5% 6% 6% Adverse Events during hospitalization 4% 5% 5% CRT-D, Cardiac resynchronization therapy – defibrillator; HF, heart failure; IQR, interquartile range. *Differences between groups is significant with p<0.001. Conclusions Patients ≥75 years of age had greater comorbidity and experienced more symptoms from their heart failure. However, they did not suffer more complications or adverse events during the index hospitalization, suggesting that CRT may safely be offered to elderly patients. Acknowledgement/Funding The work was supported by EHRA, the HFA, Biotronik, Boston Scientific, Medtronic, Sorin, St. Jude, Abbott, Bayer, Bristol-Myers Squibb and Servier

Download Full-text

Cellular Microparticles As Predictive Markers for Thrombosis and Other Clinical Events in Patients with Implanted Lvads

Blood ◽

10.1182/blood.v124.21.4995.4995 ◽

2014 ◽

Vol 124 (21) ◽

pp. 4995-4995

Author(s):

Bryan Menapace ◽

Walter Jeske ◽

Vicki Escalante ◽

Erin Coglianese ◽

Jeffrey Schwartz ◽

...

Keyword(s):

Heart Failure ◽

Adverse Events ◽

Thrombotic Event ◽

Left Ventricular ◽

Ventricular Assist Devices ◽

Left Ventricular Assist Devices ◽

Healthy Individuals ◽

Blood Samples ◽

Clinical Events

Abstract Introduction: Since the implantation of left ventricular assist devices (LVAD) in heart failure patients has become more frequent, the need to prevent, predict, and treat the associated pathologies has become paramount. The most common complications, which include thrombosis, gastrointestinal bleeds, anemia, and hemolysis, are also the adverse events that carry a less than favorable prognosis. Current methods for predicting these conditions, i.e. elevated LDH or low hemoglobin levels, typically provide an alert, at most, days in advance. This can result in inadequate time to prevent the event, forcing emergency device exchange or heart transplant. Cellular microparticles (MPs) are formed from numerous cell types as a result of activation or damage, and may play a role in mediating hemostatic or inflammatory alterations. The altered shear stress on blood induced by an implanted LVAD may be a further source of MP generation. Our study sought to determine whether alterations in blood MP levels are observed prior to the occurrence of common adverse events in patients with implanted LVADs to determine their potential clinical usefulness. Methods: Blood samples were collected peri-operatively and long-term post-operatively (until transplant or expiration) during normal clinic visits from consented patients who were implanted with a HeartMate II LVAD (Thoratec Inc, Pleasanton, CA). Fresh whole blood specimens collected in 3.2% sodium citrate were centrifuged for platelet poor plasma then ultracentrifuged (20,000 x g for 90 minutes) to pellet the MPs. Aliquots of the MP rich samples were stained with the membrane dye PKH67 (to differentiate MPs from biological membranes vs waste) then separated into five tubes containing either: Tyrode’s buffer (control), CD41-PE (platelets), CD45-PE (leukocytes), CD146-PE (endothelium), or CD235-PE [erythrocytes (RBCs)]. Samples were analyzed on an EPICS XL flow cytometer (Beckman-Coulter, Miami, FL) to determine the presence and quantity of cellular MPs using an in-house established and validated assay (modified to enhance sensitivity to MPs). Blood samples collected from six healthy individuals were processed and analyzed in the same manner to establish normal MP levels. A database of clinical events in the consented patients was created from medical chart reviews by the Heart Failure Clinic. Results: In healthy individuals, MPs derived from platelets and RBCs were most common and MPs derived from endothelium were least prevalent. Sixteen LVAD patients, with a mean follow-up of 291±91 days (range: 52-330 days), were evaluated. Thrombosis and elevated LDH each occurred once in the study patients. With both of these events, sustained elevations in MP quantities were observed. Preceding the diagnosis of thrombus, the patient had elevated CD41+ MP [2-6 standard deviations (SD) above normal], CD45+ MP (3-5 SD above normal), and CD+146 (5-8 SD above normal). These MPs, which were within 1 SD of the normal for the first two months following implant, remained at an elevated state for more than seven months. In the patient with the elevated LDH, a clinical sign of potential thrombus formation, levels for CD41+ (3-6 SD above normal), CD45+ (2-5 SD above normal), CD146+ (1-8 SD above normal), and C235+ (2-5 SD above normal) MPs were increased for two months prior to LDH elevation. Regarding hemolytic events, extreme elevations in MP levels (all four MP types were greater than 6 SD above their respective normal values) were noted in one patient 3 days before diagnosis, but elevated levels were not observed in a separate patient’s sample that was collected 43 days prior to hemolysis. Discussion: Based on the results of this ongoing study, the sustained elevations in CD41+, CD45+, and CD146+ MP quantities were an indication of an imminent thrombotic event in LVAD patients. Because these heightened quantities occurred months prior to the diagnosis, their levels may be useful to identify and prevent thrombosis in LVAD patients. With regard to hemolysis, since elevated MP levels were only observed a few days prior to diagnosis, it is unlikely that MP levels would be an effective method to identify and prevent hemolysis in LVAD patients. We are evaluating seven additional patients enrolled in this study, will consent new patients as they emerge, and continue to follow all patients long-term. The physiological/pathological function of these blood MPs will be investigated. Disclosures No relevant conflicts of interest to declare.

Download Full-text

Results of primary biventricular support: an analysis of data from the EUROMACS registry

European Journal of Cardio-Thoracic Surgery ◽

10.1093/ejcts/ezz173 ◽

2019 ◽

Vol 56 (6) ◽

pp. 1037-1045 ◽

Cited By ~ 8

Author(s):

Juliane Vierecke ◽

Brigitta Gahl ◽

Theo M M H de By ◽

Herwig Antretter ◽

Friedhelm Beyersdorf ◽

...

Keyword(s):

Heart Failure ◽

Adverse Events ◽

Right Ventricular ◽

Continuous Flow ◽

Left Ventricular ◽

Ventricular Assist Devices ◽

Short Term ◽

Ventricular Assist ◽

Assist Devices

Abstract OBJECTIVES The purpose of this study was to describe pre- and postoperative data from the EUROMACS registry with regard to indications, for and survival and complication rates of patients with primary continuous flow and pulsatile biventricular long-term assist devices (BiVADs) versus total artificial hearts (TAHs) or left ventricular assist devices (LVADs) + short-term right ventricular assist device (RVAD) implants. METHODS We investigated patients who received implants between 1 January 2011 and 21 October 2017. Clinical baseline information about comorbidities, laboratory results, medical and device therapies and echocardiographic, haemodynamic and right ventricle (RV) parameters were evaluated along with the rates of deaths and complications. RESULTS A total of 413 of 3282 patients (12.5%) needed a biventricular pump. We investigated 37 long-term BiVADs, 342 LVAD + short-term RVAD implants and 34 TAHs. Minor differences were found in the baseline characteristics of our population, which had an overall high morbidity profile. The 1-year survival rate was 55% for patients with a continuous flow BiVAD; 52% for patients with an LVAD + short-term RVAD; 37% for patients with pulsatile BiVADs; and 36% for patients with a TAH. No statistical difference was observed among the groups. Over 50% of patients with BiVAD support were classified as INTERMACS profiles 1 and 2. The percent of patients with ambulatory heart failure (INTERMACS 4‒7) undergoing BiVAD implants was modest at <15%. No patients with a pulsatile BiVAD (n = 15) or a TAH (n = 34) were implanted as destination therapy, but 27% of the patients with continuous flow BiVADs (n = 6) and 23% of the patients with LVAD + short-term RVAD (n = 342) were implanted as ‘destination’. The adverse events profile remained high, with no significant difference among pump types. The right ventricular stroke work index and right heart failure scores indicated poor RV function in all groups. After 3 months of LVAD + short-term RVAD support, 46.7% still required ongoing support, and only 18.5% were weaned from RVAD support; 33.1% died. CONCLUSIONS The mortality rate after BiVAD support was high. Survival rates and adverse events were statistically not different among the investigated groups. In the future, composite study end points examining quality of life and adverse events beyond survival may help in shared decision-making prior to general mechanical circulatory support, particularly in patients with BiVAD implants.

Download Full-text