LVAD Implantation Research Articles

Značaj funkcije desne srčane komore za ishod lečenja i remodelovanje srca nakon implantacije uređaja za trajnu mehaničku cirkulatornu potporu leve komore

The efficiency of the device for permanent circulatory support of the left ventricle has been proven through clinical practice with the trend of constant improvement of treatment results along with biotechnological progress and improvement of surgical implantation techniques. The published reports of most reference cardiac surgery centers present a one-year survival rate of over 85%, a two-year survival rate of 70% and a five-year survival rate of 45-50%. In addition to clear benefits for the patient, implantation of LVAD also carries significant specific risks, so infections, post-implantation bleeding, strokes, and right ventricular postimplantation weakness are the most common complications. Given that the progress of the LVAD program is ensured primarily by reducing the incidence of complications not related to the functioning of individual segments of the cardiovascular system, and as left ventricular function is completely replaced by LVAD device, the most recent challenge is the decision to install LVAD device in the heart with right ventricular, given that the postimplantation weakness of right ventricular is associated with proven increased mortality and morbidity. Since the 1990s, studies on hearts with implanted LVAD as a bridge to heart transplantation have shown regression of cell hypertrophy, normalization of cell size, muscle fiber architecture, and heart chamber geometry. The described changes are characterized by the notion of reverse remodeling, which is synonymous with function recovery. It is this process at the level of the right ventricle that is recognized as extremely important for the success of LVAD programs, especially in the group of patients who have a certain degree of right ventricular weakness preoperatively. The basic requirements of the cardiac surgery team are adequate preoperative assessment of right ventricular weakness, then application of measures to prevent damage and load on the right ventricle during and after LVAD implantation, as well as providing adequate therapeutic measures for right ventricular recovery in the postimplantation period.

630 Impact of right ventricular dysfunction after mitraclip treatment as a bridge to heart transplantation: insight from the mitrabridge strategy

Abstract Aims MitraClip treatment has been recently proposed as a ‘bridge strategy’ solution for advanced heart failure (HF) patients with significant functional mitral regurgitation (MR), who are potential candidates or are waiting for cardiac replacement therapy (LVAD or heart transplantation, HTx). In this clinical scenario, left-ventricular-related right ventricular dysfunction (RVD) represents an important prognostic factor. Our study aimed to investigate the possible prognostic implication of RVD in advanced HF patients treated with MitraClip as a bridge to HTx strategy. Methods and results RVD was assessed using the relationship between tricuspid annular peak systolic excursion (TAPSE) and pulmonary artery systolic pressure (PASP). All patients from the MitraBridge registry for whom these two echocardiographic parameters were available, were included in the study. A cut-off value of TAPSE/PASP ratio < 0.36 was used to defined RVD, as previously reported. The primary outcome was a composite Endpoint of all-cause death or rehospitalization for HF at 2-year. For patients who underwent LVAD implantation or HTx, follow-up data were censored at the time of those events. A total of 80 patients were included in the study. The median TAPSE/PASP ratio was 0.35 (25th–75th: 0.27–0.46), with 43 (54%) patients having a TAPSE/PASP ratio < 0.36 (RVD group). The latter had a prevalent MR ischaemic etiology (49% vs. 38%), with a more frequent history of percutaneous coronary intervention (46.5% vs. 22%, P = 0.02). Except for TAPSE (15.7 ± 3.6 mm vs. 19.2 ± 3.7 mm, P = 0.001) and PASP (61 ± 14 mmHg vs. 39.5 ± 9.5 mmHg, P < 0.001), the other echocardiographic characteristics were similar between the two study groups (overall mean left ventricular ejection fraction 26.9 ± 8%, median left ventricular end-diastolic volume index 120.7, 25th–75th: 102.2–146.5 ml/m2). After a median follow-up time of 508 (25th–75th: 160–899) days, elective HTx occurred in 12 patients (7 from the RVD group), while LVAD implantation was performed in 13 patients (7 from the RVD group). The primary outcome occurred in 30 patients (38%) with a 2-year Kaplan–Meier estimate of freedom from the composite endpoint of 41%. At univariate (HR: 1.3; 95% CI: 0.6–2.8, P = 0.451) and multivariate (HR: 1.6; CI: 0.7–3.8, P = 0.249) Cox-regression analysis, TAPSE/PASP ratio < 0.36 was not identified as an independent predictor of primary outcome. Indeed, at follow-up echocardiographic control (median time 252, 25th–75th: 122–365 days), a significant improvement in TAPSE/PASP ratio was observed in the RVD group (baseline median TAPSE/PASP ratio 0.27, 25th–75th: 0.22–0.32 vs. follow-up median TAPSE/PASP ratio 0.37, 25th–75th: 0.28–0.47, P < 0.001). Conclusions In advanced HF patients with functional MR, MitraClip treatment could prevent or ameliorate left-ventricular-related RVD, allowing safe access to HTx or LVAD.

Clinical outcome in patients with end-stage heart failure who underwent continuous-flow left ventricular assist devices in a single center.

Background/AimsThe continuous flow left ventricular assist device (cf-LVAD) has improved the survival of chronic end-stage heart failure (HF) patients. Here we describe our clinical experience of the initial 50 LVAD patients from a single center.MethodsA total of 50 patients underwent LVAD implantation as bridge to transplantation (BTT; n = 28, 56%), bridge to candidacy (BTC; n = 2, 4%), or as destination therapy (DT; n = 20, 40%) from 2012 to 2019. Pre-implant characteristics and clinical outcomes were compared between BTT/BTC and DT.ResultsThe median age of patients was 67 years (range, 59 to 73). Men were more likely to receive LVAD (76% vs. 24%) than women. DT patients were older, had smaller body surface area, and worse laboratory profiles than BTT/BTC patients. There was no in-hospital mortality. During an average of 14 months (range, 8 to 23), the all-cause mortality was 22%. The first-year survival was 86 and 90% in BTT/BTC and DT groups, respectively. Hemorrhagic stroke was the most common cause (27%) of death. In the BTT/BTC group, 22 patients successfully underwent heart transplantation during median duration of 10 months (range, 7 to 14). The most common post-LVAD complication during the first year of LVAD implantation was major bleeding (44%). A significant proportion (76%) of patients experienced rehospitalization with gastrointestinal bleeding as the most common cause.ConclusionsWe describe short-term clinical outcome of LVAD patients from a single center for the first time in Korea. With the newer generation LVAD and a dedicated team approach, improved clinical outcomes of LVAD for end-stage HF are expected.

Outcomes of Impella compared with intra-aortic balloon pump in ST-elevation myocardial infarction complicated by cardiogenic shock

BackgroundDespite limited randomized trial data demonstrating clinical efficacy, the utilization of Impella in ST-elevation myocardial infarction (STEMI) patients complicated with cardiogenic shock (CS) has increased over time. MethodsWe identified 75,769 hospitalizations with STEMI complicated by CS between October 2015 and December 2018 using International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes. From this cohort, hospitalizations were stratified according to IABP or Impella placement. The primary outcome was all-cause in-hospital mortality. Secondary outcomes were divided into efficacy, safety, and device-related complications. Propensity-score matching was used to account for differences in the baseline characteristics between the groups. Logistic regression was performed to get the odds ratio and confidence intervals. ResultsAmong 75,769 admissions with STEMI and CS, hospitalizations with <18 years old, both IABP and Impella placement, and who underwent ECMO and/or LVAD implantation were excluded. After the exclusion, out of 72,791 admissions, 25,260 (34.70%) hospitalizations received IABP, and 7825 (10.75%) received Impella support. After propensity score-matched analysis, 7345 hospitalizations were included in each group. All-cause in-hospital mortality was higher in the hospitalizations requiring Impella support as compared to IABP (42.10% vs. 31.54%, adjusted OR 1.71; 95% confidence interval (CI) 1.60–1.84, P < 0.0001). Impella was associated with a higher risk of in-hospital complications and hospitalization cost compared with IABP. ConclusionImpella compared with IABP in STEMI patients with CS was associated with higher in-hospital mortality and other adverse clinical and procedural outcomes.

Abstract 10027: Pulsatile Load, Rather Than Cardiac Power Output, for the Right Ventricle Determines the Prognosis in Heart Failure Patients

Background: Although cardiac power output (CPO), a parameter of cardiac performance, for the left ventricle (LV) is reported to be a powerful prognostic indicator in heart failure (HF), significance of the right ventricular (RV) CPO in HF has not been elucidated. On the other hand, RV pulsatile load stands for one of the prognostic markers in HF. We thus investigated the relationship of the RV CPO and pulsatile load to the outcome in HF. Methods: Right heart catheterization and echocardiography were performed in 231 HF patients (62±16 years, LV ejection fraction 42±18%). Invasive and noninvasive CPOs were calculated from mean systemic or pulmonary arterial pressures and cardiac output for the LV and RV. LV CPO was then corrected by LV mass (LV CPO/M). Pulmonary artery compliance (PAC) and the ratio of acceleration time to ejection time (AcT/ET) of the RV outflow velocity were used as parameters of RV pulsatile load. Cardiac death, HF hospitalization, ventricular arrhythmia and LVAD implantation after the examination were recorded. Results: Noninvasive CPOs were moderately correlated with invasive ones (LV: R=0.73, RV: R=0.58, P &lt;0.001 for both). During a median follow-up period of 441 days, cardiac events occurred in 57 patients. Using the cut-off of median values, lower LV CPO/M was associated with higher event rates, however, RV CPO did not discriminate the risk of future cardiac events. In contrast, higher RV pulsatile load was associated with higher event rates regardless of the level of LV CPO/M ( Figure ). In multivariable Cox proportional hazard analyses, echocardiographic LV CPO/M and AcT/ET both determined cardiac events independently of age, NYHA classification, LV ejection fraction and plasma brain natriuretic peptide levels. Conclusion: Pulsatile load, rather than CPO, for the RV was associated with cardiac events in HF. Furthermore, combination of echocardiographic LV CPO/M and AcT/ET could become a novel noninvasive prognostic indicator in HF patients.

Abstract 12210: Long-Term Efficacy and Safety of ARRY-371797 (PF-0765803) in an Open-Label Rollover Study in Patients With Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation

Introduction: Dilated cardiomyopathy due to LMNA gene mutations ( LMNA -DCM) accounts for ~6% of DCM cases and is a life-threatening condition with a high unmet need. No disease-specific treatment targeting the underlying mechanism of disease is currently available. ARRY-371797 (PF-0765803), a potent, selective, oral, small-molecule inhibitor of the p38α MAPK pathway, improved exercise capacity (6MWT) in symptomatic LMNA -DCM patients (n=12) in a 48-week, open-label, Phase 2 study. Methods: This was an open-label rollover study of the long-term safety and efficacy of ARRY-371797 in symptomatic LMNA -DCM patients previously participating in the Phase 2 parent study, with eligible patients continuing on the same dose. Safety and efficacy assessments (6MWT, NT-proBNP, and KCCQ) were performed at Weeks 48, 72, 96, 120, and 144 from treatment initiation in the parent study. Results: Eight patients were enrolled (mean [SD] age, 51 [10] years; 4 males). There was a &gt;30 m mean improvement and &gt;10% mean increase in 6MWT distance from parent study baseline up to Week 120 ( Table ), with 3 patients (37.5%) having ≥10% improvement from baseline to Week 144. The decrease in mean NT-proBNP concentration in the parent study was maintained ( Table ). KCCQ Physical Limitation score increased at all visits except Week 48. Changes in KCCQ Clinical Summary and Overall Summary scores were variable. Treatment was generally well tolerated: 3 patients discontinued due to causes not considered treatment-related (UTI and nausea, CRT-D, and LVAD implantation); 2 experienced Grade 1 adverse events considered treatment-related. There were no deaths. Conclusions: ARRY-371797 was generally well tolerated, with evidence suggesting preserved exercise capacity over &gt;2 years’ follow-up. Efficacy and safety of ARRY-371797 is being investigated in the REALM-DCM trial, an ongoing, pivotal, Phase 3, randomized, placebo-controlled study in LMNA -DCM.

Abstract 12310: Metabolic Gain Index is Associated With Adverse Clinical Outcomes Independently of Peak VO 2 in Patients With Heart Failure With Reduced Ejection Fraction Undergoing Cardiopulmonary Exercise Stress Testing

Introduction: Cardiopulmonary exercise stress test (CPET) is an essential prognostic tool in patients with heart failure with reduced ejection fraction (HFrEF) for advanced therapy evaluation. We studied the predictive utility of the metabolic gain index (MGI), which reflects the relative gain of the CPET-estimated stroke volume by the relative change in the product of VO 2 and heart rate (HR) from resting to peak exercise. This novel MGI aims to reflect cardiac reserve function, and, overall prognosis in HFrEF patients. Hypothesis: The MGI is an independent predictor of adverse outcomes in patients with HFrEF. Methods: We reviewed electronic medical records of 843 HFrEF patients (LVEF ≤40%) undergoing CPET from 12/2012 to 9/2020. The MGI was calculated using the formula, [(Peak VO 2 x Peak HR)-(Resting VO 2 x Resting HR)]/(Resting VO 2 x Resting HR). Patients with hypotensive or bradycardia response during exercise were excluded. Primary outcome was the composite of all-cause mortality, LVAD implantation, and heart transplantation. Multivariable Cox proportional hazard models and log rank test were used. For subgroup analysis, patients were stratified by the RER, age, sex, BMI, and beta-blocker use. Results: In our study cohort (mean age 56.2±12.2 years, 73% men, 85% with beta-blockers, mean LVEF 24.8±8.0 %, 16% with BMI ≥35 kg/m 2 , and 75% with RER &gt;1.05), there were 279 (33.1%) patients developed adverse events during median follow up time of 897 days. Lower MGI was independently associated with increased risk of the adverse outcomes with adjustment for age, sex, comorbidities, LVEF, and peak VO 2 (quartile 1 vs 4, hazard ratio 1.83, 95% CI 1.03-3.25, p =0.040, Figure 1A ), especially in patients with RER &gt; 1.05, BMI &lt; 35 kg/m 2 , and without beta-blocker use ( Figure 1B ). Conclusions: Lower MGI is associated with poor prognosis independently of peak VO 2 . The prognostic value of MGI needs to be further corroborated in other multicenter HFrEF cohorts.

Abstract 10726: Cardiac Resynchronization Therapy Response in Cardiac Sarcoidosis

Introduction: Cardiac Sarcoidosis (CS) is a non-ischemic cardiomyopathy (NICM) characterized by infiltration of non-caseating granulomas involving in the heart with highly variable clinical manifestations. Cardiac resynchronization therapy (CRT) has shown significant promise in NICM, though little is known about its effectiveness in patients with CS. Hypothesis: We sought to determine if CRT improved cardiac remodeling and reduced hospitalizations in patients with CS. Methods: We retrospectively reviewed all patients with a clinical or histological diagnosis of CS who underwent CRT implantation at a Mayo Clinic site from 2000-2021. Baseline characteristics, echocardiographic parameters, heart failure hospitalization, and major adverse cardiac events (MACE) were assessed. Results: Our cohort was comprised of 55 patients with 61.8% male and a mean age of 58.7 ± 10.9 years. At baseline, 38 (69.1%) patients had isolated CS, while 17 (30.9%) had evidence of CS with extra-cardiac sarcoidosis. The overwhelming majority underwent CRT-D implantation (n=52, 94.5%) with 67.3% of implanted devices upgrades from prior pacemaker or implantable cardioverter defibrillator. At 6 months post-implantation there was no significant different in ejection fraction (34.8 ± 10.9 % vs. 37.7 ± 14.2 %, p = 0.237), left ventricular end systolic diameter (49.1 ± 9.9 mm vs. 45.7 ± 9.9 mm, p = 0.077) or left ventricular end-diastolic diameter (58.5 ± 10.2 mm vs. 57.5 ± 8.1 mm, p = 0.574). Within the first 6 months post-implantation, 5 (9.1%) patients sustained a heart failure hospitalization. At a mean follow up of 4.1 ± 3.7 years, 14 (25.5%) patients experienced a heart failure hospitalization, 11 (20.0%) underwent cardiac transplantation, 1 (1.8%) underwent LVAD implantation and 7 (12.7%) patients died. Conclusions: Our findings suggest a poor response to CRT in patients with CS with no significant evidence of reverse remodeling within 6 months and a substantial proportion of patients progressing to advanced heart failure therapies.

Degree of change in right ventricular adaptation measures during axillary Impella support informs risk stratification for early, severe right heart failure following durable LVAD implantation

Risk assessment for early, severe right heart failure (RHF) after LVAD implantation remains imperfect. We sought to define the differences in RV adaptation and load after axillary Impella support between patients who experienced RHF and those who did not. Seventeen of 18 patients included were deemed intermediate or high risk for RHF by EUROMACS-RHF score. Before Impella insertion, RV adaptation parameters (RAP, RAP:PCWP, PAPi) were worse in the non-RHF group compared to the RHF group. In both groups, RV load parameters (effective pulmonary arterial elastance, pulmonary vascular resistance, and pulmonary vascular compliance) improved after Impella insertion. Lesser improvements in RV adaptation were seen in the RHF group. Moreover, load-to-adaptation relationships (EA/RAP and EA/RAP:PCWP) worsened to a greater degree. In patients at intermediate or high risk for RHF after LVAD, assessment of RV adaptation and load during axillary Impella support may improve risk stratification.

Direct transaortic transcather valve-in-valve implantation into a mechanical aortic valve prosthesis during left ventricular assist device implantation: description of a surgical technique.

The presence of a mechanical aortic valve prosthesis is considered a relative contraindication for left ventricular assist device implantation (LVAD) due to the occurrence of thromboembolic events. Five patients were operated on for LVAD implantation with status post mechanical aortic valve implantation (n = 3 with status post Bentall procedure). After removal of the leaflets, a transcatheter balloon-expandable valve was placed within the mechanical ring in all patients. Three patients were discharged from hospital with a maximum follow-up of 3.3 years. Transaortic transcatheter valve implantation into a mechanical aortic valve during LVAD implantation is a feasible option. It reduces operative times and might also prevent thromboembolic events.

Improvement of exercise tests and reduction of heart failure biomarkers in short term follow up after comprehensive rehabilitation program of patients with implanted LVAD

Abstract Background There is increasing recognition of the importance of rehabilitating patients after LVAD implantation. The novel method of comprehensive rehabilitation starting directly after LVAD implantation was designed for our LVAD patients population. Aim of the study The study aimed to determine, if novel rehabilitation program improves functional and biochemical parameters in patients after recent LVAD implantation. Study group 37 recent LVAD (22 Heart Mate III, 15 HeartWare) recipients (19–67, mean 58.7 years, 35 men) participated in specially designed rehabilitation program. The program included 4–5 weeks of sationary rehabilitation: supervised endurance training on cycloergometer (5 times per week), resistance training, general fitness exercises with elements of equivalent and coordination exercises (every day). It was followed by individual exercises performed at home. At the beginning and at the end of rehabilitation program the patients performed 6 minute walking test (6MWT), cardiopulmonary exercise test (CPET). Following prognostic biomarkers of heart failure: NT-proBNP, galectin-3 and ST2 were also measured. Results See table 1. Increase of 6MWT distance, higher maximal workload, peak VO2 and upward shift of anaerobic threshold in CPET were observed in all patients. Significant reductions of NTproBNP, ST2 and galectin-3 levels were observed. There were no major adverse events during rehabilitation. Conclusions Comprehensive novel rehabilitation in LVAD recipients is safe and results in significant improvement of functional tests and biomarkers of heart failure. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): National Center for Research and Development: National grant - STRATEGMED II,

Long-term outcome after adding an ICD to CRT in non-ischemic patients

Abstract Background There are limited and contradictory data on the long-term mortality benefit of cardiac resyncronization therapy with implantable cardioverter defibrillator (CRT-D)as compared to Cardiac resynchonization therapy with pacemaker. Purpose Our aim was to evaluate the long-term all-cause mortality benefit of CRT-D compared to CRT-P by ischemic aetiology. Methods Between 2000 and 2018, patients, who underwent successful CRT implantation were registered. From 2524 patients, 1366 (54%) had a CRT-D implantation and 1099 (44%) had CRT-P implantation. 59 (2%) patients were excluded from the current analysis, who had an ICD upgrade with a CRT-P device during the follow-up. The primary composite endpoint was all-cause mortality, LVAD implantation or heart transplantation. Kaplan-Meier and multivariate Cox regression analyses were used to assess all-cause mortality in the total cohort and by ischemic aetiology. Results The median follow-up time was 3.6 years. During this time 1389 patients died from any cause, 692 patients (50%) with a CRT-D device, and 697 patients (50%) with a CRT-P. Patients in the CRT-D group were younger (67 years vs. 70 years; p&amp;lt;0.001), had a less advanced functional class (NYHA III/IV., 52.2% vs. 61.4%; p&amp;lt;0.001), wider QRS [160ms (140/180) vs. 160ms (140/170); p=0.03] and less females (18.9% vs. 33.3%; p&amp;lt;0.001) with an ischemic aetiology (57.7% vs. 40.2%; p&amp;lt;0.0001). CRT-D patients had a better renal function [eGFR, 60.5 (ml/min/1.73m2) vs. 57 (ml/min/1.73m2); p=0.02], decreased ejection fraction (28% vs. 30%; p=0.002), had more frequently ventricular arrhythmia (36% vs. 9.8%; p&amp;lt;0.001). CRT-D patients took more amount of beta-blockers (90.2% vs. 87.3%; p=0.03), MRA (72.2% vs. 61.6%; p&amp;lt;0.001) and amiodaron (32.2% vs. 20%; p&amp;lt;0.001). By multivariate analysis in the total cohort gender, renal function, functional class, aetiology, and the presence of ICD were independent predictors of all-cause mortality. By multivariate analysis, patients with a CRT-D device showed a 25% decreased risk of long-term mortality compared to CRT-P alone in the total cohort. (aHR 0.75; 95% CI 0.58–0.97; p=0.03). When patients were analysed by their etiology, those with non-ischemic cardiomyopathy showed a significant mortality benefit from ICD even after adjusting for relevant clinical variables (aHR 0.45; 95% CI 0.28–0.72; p&amp;lt;0.01). In ischemic patients despite of having a clear mid-term mortality benefit of ICD, it is decreasing after 5 years and less considerable after adjusting for clinical variables (aHR 0.92; 95% CI 0.67–1.27; p=0.60). Conclusions Although, CRT-D had a notable mid-term mortality benefit in ischemic patients compared to CRT-P alone, after 5 years it became less pronounced. While in non-ischemic patients, the benefit of adding an ICD to CRT lasts over 10 years. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Project no. NVKP_16-1–2016-0017 (“National Heart Program”) has been implemented with the support provided by the National Research, Development and Innovation Fund of Hungary, financed under the NVKP_16 funding scheme. The research was financed by the Thematic Excellence Programme (2020-4.1.1.-TKP2020) of the Ministry for Innovation and Technology in Hungary, within the framework of the Therapeutic Development and Bioimaging thematic programmes of the Semmelweis University. All-cause mortality

Impact of right ventricular dysfunction after MitraClip treatment as a bridge to heart transplantation: insights from the MitraBridge registry

Abstract Background MitraClip treatment has been recently proposed as a “bridge strategy” solution for advanced heart failure (HF) patients with significant functional mitral regurgitation (MR), who are potential candidates or are waiting for cardiac replacement therapy (LVAD or heart transplantation, HTx). In this clinical scenario, left-ventricular-related right ventricular dysfunction (RVD) represents an important prognostic factor. Purpose Our study aimed to investigate the possible prognostic implication of RVD in advanced HF patients treated with MitraClip as a bridge to HTx strategy. Methods RVD was assessed using the relationship between tricuspid annular peak systolic excursion (TAPSE) and pulmonary artery systolic pressure (PASP). All patients from the MitraBridge registry for whom these two echocardiographic parameters were available, were included in the study. A cut-off value of TAPSE/PASP ratio &amp;lt;0.36 was used to defined RVD, as previously reported. The primary outcome was a composite end-point of all-cause death or rehospitalization for HF at 2-year. For patients who underwent LVAD implantation or HTx, follow-up data were censored at the time of those events. Results A total of 80 patients were included in the study. The median TAPSE/PASP ratio was 0.35 (25th-75th: 0.27–0.46), with 43 (54%) patients having a TAPSE/PASP ratio &amp;lt;0.36 (RVD group). The latter had a prevalent MR ischemic etiology (49% vs 38%), with a more frequent history of percutaneous coronary intervention (46.5% vs 22%, p=0.02). Except for TAPSE (15.7±3.6 mm vs 19.2±3.7 mm, p=0.001) and PASP (61±14 mmHg vs 39.5±9.5 mmHg, p&amp;lt;0.001), the other echocardiographic characteristics were similar between the two study groups (overall mean left ventricular ejection fraction 26.9±8%, median left ventricular end-diastolic volume index 120.7, 25th-75th: 102.2–146.5 mL/m2). After a median follow-up time of 508 (25th-75th: 160–899) days, elective HTx occurred in 12 patients (7 from the RVD group), while LVAD implantation was performed in 13 patients (7 from the RVD group). The primary outcome occurred in 30 patients (38%) with a 2-year Kaplan-Meier estimate of freedom from the composite end-point of 41%. At univariate (HR 1.3 95% CI 0.6–2.8, p=0.451) and multivariate (HR 1.6 CI 0.7–3.8, p=0.249) Cox-regression analysis, TAPSE/PASP ratio &amp;lt;0.36 was not identified as an independent predictor of primary outcome. Indeed, at follow-up echocardiographic control (median time 252, 25th-75th: 122–365 days), a significant improvement in TAPSE/PASP ratio was observed in the RVD group (baseline median TAPSE/PASP ratio 0.27, 25th-75th: 0.22–0.32 vs follow-up median TAPSE/PASP ratio 0.37, 25th-75th: 0.28–0.47, p&amp;lt;0.001). Conclusion In advanced HF patients with functional MR, MitraClip treatment could prevent or ameliorate left-ventricular-related RVD, allowing safe access to HTx or LVAD. Funding Acknowledgement Type of funding sources: None.

VAD related infections and the risk of pump thrombosis and thromboembolic events: a EUROMACS study

Abstract Background In patients supported by a ventricular assist device (VAD) major infections are a frequently reported adverse event with increased morbidity and mortality. Purpose The purpose of this study was to investigate the possible association between infections and cerebrovascular accidents (CVAs) in VAD patients. Methods An analysis of the European Registry for Patients Assisted with Mechanical Circulatory Support (EUROMACS) was performed identifying all patients aged ≥18 years with a LVAD or BiVAD implantation. Infections were categorized as VAD-specific infections, VAD-related infections and, non-VAD infections. An extended Kaplan-Meier analysis for the risk of CVA and mortality with infection as a time-dependent covariate was performed. Furthermore, a multivariable Cox proportional hazard model was performed including 24 variables. Results For this analysis 3784 patients were included, with 45 patients being supported by a BiVAD and 3739 by an LVAD. The majority of patients were male (83.2%) and 60.5% had an INTERMACS patient profile 2 or 3. During follow-up, 3108 major infections were identified in 1385 (36.6%) of the patients, while 673 CVAs were identified in 545 (14.4%) of the patients. Extended Kaplan-Meier analysis with first infection as time-dependent covariate revealed a hazard ratio (HR) for CVA of 1.95 (95% CI: 1.57–2.36; p&amp;lt;0.005) (Figure) and 1.50 (95% CI: 1.33–1.68, p&amp;lt;0.005) for mortality. Multivariable analysis confirmed a significant association for infection and CVAs with a HR of 1.46 (95% CI: 1.29–1.64). With infections subcategorized, VAD-specific (HR: 1.57 (95% CI: 1.18–2.09)) and VAD-related infections (HR: 2.04 (95% CI: 1.44–2.89)) remained significantly associated with CVA but non-VAD infections (HR: 1.22 (95% CI: 0.92–1.64)) were not. Conclusion Both VAD-related and VAD-specific infections are associated with a significantly increased risk of CVA with increased risk of mortality. Funding Acknowledgement Type of funding sources: None. KM freedom of CVA and infection

Long-term outcome of patients with cardiolaminopathy undergoing defibrillator implantation: single-center experience

Abstract Background Mutations in the LMNA gene are associated with a high arrhythmic risk. The history of the disease in patients undergoing ICD implantation is poorly characterized. Purpose To evaluate the phenotype of patients with cardiolaminopathy at the time of first ICD implantation, the incidence, characteristics and timing of ventricular arrhythmias (VAs) during follow up and the predictive value of the European score (that assigns a point each to non-sustained VT (NSVT), left ventricular ejection fraction (LVEF)&amp;lt;45% at first contact, male sex and non-missense mutations) and of the Wahbi score (that also includes conduction disturbances) for both VAs and heart failure (HF) related outcomes. Methods Patients were identified retrospectively. Clinical and device data were collected at baseline and during follow-up. Results We identified 26 patients (54% male, 42±8 years, 31% with familial history of sudden cardiac death, 31% with non-missense mutation) undergoing ICD implantation, 96% in primary prevention, 47% with single chamber ICD, 38% with dual chamber ICD. At the time of implantation, 30% had skeletal muscle involvement, 15% history of syncope, 4% of cardiac arrest, 62% previous NSVT. Also, 38% had a history of supraventricular arrhythmias and 61% had AV conduction disturbances. LVEF was 41±11%, 35% were in NYHA class ≥2, the mean European and Wahbi scores were 2.1±0.8 and 18.2±8.9, respectively. During 8.3±5 years, 15% were transplanted, 8% died due to HF, 4% underwent LVAD implantation, despite 31% having received an upgrade to CRT-D. Appropriate device interventions occurred in 46% of patients with a median time to first event of 29 months (IQR 13–93), for a total of 137 ATP, 51% of which effective (median 3ATP/patient, IQR 1–8) and of 26 shocks, 96% of which effective (median 2 shocks/patient, IQR 1–3); 12% had an arrhythmic storm. The first treated arrhythmia was a polymorphic VT/VF in 17%, a monomorphic VT in the others (medium cycle length 293±37 msec). Survival free from appropriate ICD interventions at 1 and at 5 years was 75% and 19% respectively in case of a European score ≥3 vs 94% and 82% in case of a score &amp;lt;3 (Logrank test p&amp;lt;0.01), 72% and 46% in case of Wahbi score ≥30 vs 100% and 86% with score &amp;lt;30 (p&amp;lt;0.01), with no differences in terms of death/transplant (figure). At last follow-up, 92% of patients a were taking beta-blocker, 42% amiodarone, 8% sotalol, 4% flecainide, 8% mexiletine. Also, 4% had undergone invasive VT ablation, 8% bilateral cardiac sympathetic denervation. Conclusions Patients with cardiolaminopathy are at a high risk of both arrhythmic and heart failure progression over the first decade after implantation of the first ICD. A European score ≥3 identifies patients with 5-year shock/ATP free survival of less than 20% but does not predict death/transplantation. The first arrhythmic event in these patients is more frequently a rapid monomorphic VT with modest ATP efficacy. Funding Acknowledgement Type of funding sources: None.

The growing role of designated communicators in the monitoring of patients with left ventricular assist device in the era of the COVID pandemic

Abstract Background Left ventricular assist devices (LVAD) are increasingly implanted in patients with end-stage heart failure. Patients require special care in terms of the safety and effectiveness of therapy, but during pandemic lockdown it is much more difficult to achieve. For many years at our institution, apart from routine personal visits, we have been using the REMEDIZER® internet communicator for remote care in LVAD group of patients. Objective - evaluation of the safety and effectiveness of remote monitoring in the care of patients with LVAD during the COVID pandemic – evaluation of the safety of remote monitoring with a designated communicator instead of personal visits Methods During the lockdown period (01/03/2020 - 31/12/2020), 72 patients (3 female) pts mean age 54.7±12,1 years with LVAD were monitored. For epidemiological reasons, the number of personal visits has been reduced in favor of telephone consultations and an increased volume of data entered into the REMEDIZER® internet communicator. The data collected in this period were compared with the data collected on 1 March 2019 - 31 December 2019, when: 53 pts (1 female) mean age 56,2±11,78 years were routinely, personally controlled at the Center for at least every 3 months and had blood, echo and LVAD examinations. Patients entered pump parameters: flow, motor speed, power consumption, pulse and blood pressure, body weight and temperature, at least twice a day (morning and evening) INR and dose of warfarin used were also reported. The number of complications during LVAD support was assessed: death or heart transplantation major complications: stroke, hemorrhage, pump thrombosis also other like arrhythmias requiring ICD intervention, hospitalization. Results Mean time of monitoring from hospital discharge after LVAD implantation to the end of observation in 2020 cohort was 651±486 days compared to 586±508, days in 2019 cohort In 2019, personal visits were performed significantly more often, 94 v. 17 (p&amp;lt;0.05), while remote visits (by phone or internet) were significantly more frequent in 2020 (2033 v. 1390). In 2019 patients were hospitalized significantly more often (28 vs. 10), but if we considered urgent hospitalizations, the differences were not statistically significant (9 vs. 8). In 2020, 5 patients (6,94%) died compared with 4 (7,55%) in 2019 (NS). In 2020, 9 patients (12,5%) were transplanted v. 3 (5,66%) in 2019. We observed 22 episodes of major complications in the 2020 cohort vs 20 in 2019 (NS); 11 ICD interventions vs 13 in 2019 (NS). Conclusions Replacing routine personal visits with increased patient self-control and constant remote contact with the center allowed a safe organization of patient care during COVID-19 pandemic The use of REMEDIZER® internet communicator dedicated for LVAD patients for remote care control proved to be effective and safe to control LVAD patients. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): The study is funded by the National Center for Research and Development, Poland

Long-Term Outcomes in Ventricular Assist Device Outflow Cannula Anastomosis to the Descending Aorta

BackgroundLeft ventricular assist device (LVAD) implantation via thoracotomy with outflow cannula anastomosis to the descending aorta is an alternative implantation technique that uses a single incision and avoids anterior mediastinal planes. We evaluated long-term survival and hospital readmissions after LVAD implantation via thoracotomy with outflow cannula anastomosis to the descending aorta. MethodsAdult patients implanted with a continuous flow centrifugal LVAD at an academic center were retrospectively analyzed. Patients were assigned to 1 of 2 cohorts based on the anastomosis site of the LVAD outflow cannula: ascending aorta cohort (Asc-Ao) and descending aorta cohort (Desc-Ao). Primary and secondary outcomes were survival and hospital readmissions during device support. Readmission analysis included patients with ≥30-day survival after discharge. Multivariable analysis and propensity score matching were performed. ResultsSurvival analysis included 330 patients (Asc-Ao: 272, Desc-Ao: 58). Readmission analysis included 277 patients (Asc-Ao: 231, Desc-Ao: 46) and a total of 1028 readmissions during 654 patient-years of follow-up were analyzed. There was no significant difference in in-hospital, 6-month, 1-year, 3-year, and 5-year mortality between the two cohorts. Readmission-free survival, 30-day readmission, number of admissions per year and hospital length of stay per year were not significantly different between the 2 cohorts after adjustment for patient characteristics. ConclusionsThis study found no difference in long-term survival or hospital readmissions between LVAD implantation via thoracotomy with outflow cannula anastomosis to the descending aorta and standard implantation.

Comparison of ECMO vs ECpella in Patients With Non-Post-Pericardiotomy Cardiogenic Shock: An Updated Meta-Analysis

IntroductionThe impact of Impella and ECMO (ECPELLA) in cardiogenic shock (CS) remains to be defined. The aim of this meta-analysis is to evaluate the benefit of ECPELLA compared to VA-ECMO in patients with non post-pericardiotomy CS. MethodsAll studies reporting short term outcomes of ECpella or VA ECMO in non post-pericardiotomy CS were included. The primary endpoint was 30-day mortality. Vascular and bleeding complications and LVAD implantation/heart transplant within 30-days were assessed as secondary outcomes. ResultsOf 407 studies identified, 13 observational studies (13,682 patients, 13,270 with ECMO and 412 with ECpella) were included in this analysis. 30-day mortality was 55.8% (51.6–59.9) in the VA-ECMO group and 58.3% (53.5–63.0) in the ECpella group. At meta-regression analysis the implantation of IABP did not affect mortality in the ECMO group. The rate of major bleeding in patients on VA-ECMO and ECpella support were 21.3% (16.9–26.5) and 33.1% (25.9–41.2) respectively, while the rates of the composite outcome of LVAD implantation and heart transplantation within 30-days in patients on VA-ECMO and ECpella support were 14.4% (9.0–22.2) and 10.8%. When directly compared in 3 studies, ECpella showed a positive effect on 30-day mortality compared to ECMO (OR: 1.81: 1.039–3.159). ConclusionOur data suggest that ECpella may reduce 30-day mortality and increase left ventricle recovery, despite increased of bleeding rates.

Impact of Ischaemic and Dilated Cardiomyopathy on Short-Term and Long-Term Survival After Ventricular Assist Device Implantation: A Single-Centre Experience

Prognosis of patients with end-stage heart failure is known to be impacted by the aetiology of heart failure (HF). Ischaemic cardiomyopathy (ICM) and dilated cardiomyopathy (DCM) are the most frequent pathologies necessitating ventricular assist device (VAD) support in these patients. However, the specific impact of ICM and DCM in clinical outcomes after VAD implantation remains unclear. Therefore, this study aimed to analyse clinical differences in ICM and DCM patients after LVAD surgery from the current institution. All consecutive patients from the LVAD centre were included in this retrospective study. To analyse specific differences in in-hospital outcomes, patients were divided into two groups: ICM and DCM. Long-term follow-up was calculated by Kaplan-Meier estimation of survival. Between January 2010 and July 2020, 60 consecutive patients underwent LVAD implantation at the institution: 36 patients (60%) were supported due to end-stage ICM and 24 patients (40%) in regard of therapy-refractory DCM. Baseline characteristics showed no between-group differences. The ICM patients showed a clear trend to higher amount of additional cardiac procedures during VAD surgery (36% ICM vs 12% DCM; p=0.052). In-hospital mortality was comparable between ICM and DCM patients (36% ICM vs 21% DCM; p=0.206). A trend towards higher frequency of pump thrombosis was seen in DCM patients (p=0.080). Long-term survival was comparable between the groups. The aetiology of heart failure did not impact short-term or long-term clinical outcomes after VAD surgery. Multicentre registry data are necessary to substantiate these findings.

Comparison of Impella 5.0 and extracorporeal left ventricular assist device in patients with cardiogenic shock.

Choice of mechanical circulatory support to stabilize hemodynamics until cardiac recovery or next treatment is a strategic cornerstone for improving outcomes in patients with severe cardiogenic shock. We aimed to clarify the difference in treatment course and outcomes with the use of Impella 5.0 and an extracorporeal left ventricular assist device (eLVAD) in patients with cardiogenic shock refractory to medical therapy or other mechanical circulatory support. We performed a retrospective medical record review of consecutive patients who were implanted with Impella 5.0 or eLVAD as a bridge to decision at our medical center. A total of 26 patients (median age 40 years, 16 males) were analyzed. Of seven patients managed with Impella 5.0, the Impella 5.0 was removed successfully in two patients and five patients underwent surgery for durable LVAD implantation. Of 19 patients managed with eLVAD, the eLVAD was successfully removed in 3 patients, 9 patients required durable LVAD, and 7 patients died during eLVAD management. The period between Impella 5.0 or eLVAD implantation to durable LVAD surgery was significantly shorter with Impella 5.0 (58 vs 235 days, p = 0.001). Cardiopulmonary bypass time was significantly shorter and a significantly smaller amount of red blood cell transfusion was required with Impella 5.0 (149 vs 192 min, p = 0.042; 7.0 vs 15.0 units, p = 0.019). There were four massive stroke events with eLVAD, but no massive stroke event with Impella 5.0. Impella 5.0 facilitates smoother management as a bridge to decision and reduces surgical invasiveness during durable LVAD implantation.