Driveline infections in left ventricular assist devices-Incidence, epidemiology, and staging proposal.

BACKGROUND: Driveline infections (DLI) are a serious complication in patients with left ventricular assist devices (LVAD). Apart from the differentiation between superficial and deep DLI, there is no consensus on the classification of the severity of DLI. Little is known about risk factors and typical bacteria causing DLI in centrifugal-flow LVADs. METHODS: In this single-center study with 245 patients, DLI were classified by their local appearance using a modification of a score suggested by the Sharp Memorial group. The driveline exit site was inspected routinely every 6 months. RESULTS: Severe DLI were detected in 34 patients (15%) after 6 months and in 24 patients (22%) after 24 months. The proportion of patients with DLI increased significantly during the follow-up (p = 0.0096). The most common bacteria in local smears were Corynebacterium, coagulase-negative Staphylococcus, and Staphylococcus aureus. Fifty-nine patients were hospitalized more than once for DLI. In these patients, S. aureus was the most common bacterium. It was also the most common bacterium in blood cultures. Higher BMI, no partnership, and a HeartMate 3 device were identified as risk factors for DLI in a multivariable cause-specific Cox regression. CONCLUSION: This study is a standardized analysis of DLI in a large cohort with centrifugal-flow LVADs.

Insights into the daily life of ventricular assist device coordinators: Outcome of an international questionnaire.

BACKGROUND: As the incidence of heart failure in developed countries is on the rise, mechanical circulatory support (MCS) often remains the only treatment option for patients with end-stage heart failure and is well established worldwide. Even though VAD coordinators play a key role in VAD programs, their responsibilities and daily duties are not clearly defined and characterized. Recently published data from the first 5-year multicenter clinical trial assessing experience with the HeartMate 3 left ventricular system (Abbott, Abbott Park, IL) show an overall survival of 61% at 5 years. When it comes to possible improvements to these systems, it is necessary for developers not only to know the status quo but also to determine and consider the visions and wishes of those individuals who take care of patients, provide education and deal with possible complications. This would be helpful a meaningful effort towards implementing a standard of care. METHODS: To fill this knowledge gap, we conducted an online survey using the SurveyMonkey tool, addressing representatives of programs implanting VADs worldwide. Representatives answered a standardized block of 14 questions and were asked to provide responses within 3 months. RESULTS: A total of 91 VAD coordinators from centers of various regions of the world completed the survey. The majority came from European countries. The numbers of patients followed up by the centers ranged from <20 to 390 patients. The majority of VAD coordinators had a nursing background (68%). Seventy-seven percent of the centers operate a 24-h hotline and 3-monthly visits to the outpatient department are most common. Fifty-nine percent of the centers do not use an infection scoring system for driveline wound care. The majority of the centers indicated that an optimized follow-up concept including wound care, medication, and social care is crucial and the key issue for an improved outcome. Smaller components and intensified psychosocial support ranked highest in questions about how to improve quality of life. Surprisingly, the future prospects of telemetric monitoring were not rated high in significance. CONCLUSIONS: There is a wide variability in the composition and tasks of VAD programs worldwide. Implementing a standard of care and improving psychosocial care as well as equipment is regarded most important to improve outcomes and quality of life. From the point of view of those responsible, the significance of telemetric monitoring seemed overrated.

Severe pulmonary valve insufficiency caused by transjugular cannulation of pulmonary artery for right ventricular assist device: diagnosis and surgical solution-a case report.

Implantation of a temporary percutaneous right ventricular assist device (RVAD) in patients with right heart failure after left ventricular assist device (LVAD) implantation is an established technique that may cause complications. We present a 60-year-old male patient who underwent urgent LVAD implantation. On the second postoperative day the patient developed acute right heart failure. We implanted a temporary percutaneous RVAD with two cannulas via the right internal jugular vein and the right femoral vein. Transesophageal echocardiography revealed severe pulmonary insufficiency. After performing re-sternotomy we anastomosed a prosthetic graft to the pulmonary trunk (PT), performed subxiphoid tunneling of the graft and replaced the transjugular outflow cannula. The pulmonary regurgitation caused by the percutaneous transvalvular cannula disappeared. In such case a direct anastomosis to the PT is the solution.

Results of non-elective withdrawal of continuous-flow left ventricular assist devices in selected patients.

BACKGROUND: Protocols have been developed to identify patients for elective withdrawal of continuous-flow left ventricular device (cfLVAD) support. However, little is known about non-elective explantation or decommissioning of cfLVADs. METHODS: A retrospective analysis of all patients who underwent left ventricular assist device (LVAD) explantation or decommissioning at a single center between 2002 and 2021 was performed. RESULTS: Sixty-one patients underwent withdrawal of a cfLVAD (HeartMate II [Abbott] n = 17, HeartMate 3 [Abbott] n = 2, HeartWare HVAD [Medtronic] n = 36, INCOR [Berlin Heart] n = 6). The median follow-up after withdrawal was 1,039 days. The survival at 5 years was 76.1% (95% CI: 64.2%-95.2%). Predictors of worse outcomes in univariate regressive analysis were the duration of heart failure and the age at LVAD implantation. Of the 61 patients, 40 underwent elective withdrawal following a specific protocol. The other twenty-one patients underwent non-elective withdrawal of the cfLVAD because of device infection (n = 12), device thrombosis (n = 6), device malfunction (n = 2) or due to acute intracerebral bleeding (n = 1), also with an excellent survival at 5 years of 81.3%. (95% CI: 63.8-1). The withdrawal was performed in these patients even though they did not fulfill established criteria for successful explantation or decommissioning like clinical stability (n = 21), left ventricular end-diastolic diameter ≤ 55 mm (n = 3), performance of right heart catheterization (n = 6), or pulmonary artery wedge pressure ≤ 15 mm Hg (n = 3). CONCLUSION: Non-elective withdrawal is possible in selected patients after discussion in a team of experienced cardiac surgeons, cardiologists, technicians, and VAD coordinators. The appropriate preoperative assessment before decommissioning or explantation of a cfLVAD warrants further investigation.

A multicenter evaluation of external outflow graft obstruction with a fully magnetically levitated left ventricular assist device.

BACKGROUND: The HeartMate 3 (HM 3; Abbott) left ventricular assist device (LVAD) has improved hemocompatibility-related adverse outcomes. In sporadic cases, external compression of the outflow graft causing obstruction (eOGO) can result from substance accumulation between the outflow graft and its bend relief. We sought to evaluate the prevalence, course, and clinical implications of eOGO in an international study. METHODS: A multicenter retrospective analysis of HM 3 LVADs implanted between November 2014 and April 2021 (n = 2108) was conducted across 17 cardiac centers in 8 countries. We defined eOGO as obstruction >25% in the cross-sectional area in imaging (percutaneous angiography, computed tomography, or intravascular ultrasound). The prevalence and annual incidence were calculated. Serious adverse events and outcomes (death, transplantation, or device exchange) were analyzed for eOGO cases. RESULTS: Of 2108 patients, 62 were diagnosed with eOGO at a median LVAD support duration of 953 (interquartile range, 600-1267) days. The prevalence of eOGO was 3.0% and the incidence at 1, 2, 3, 4, and 5 years of support was 0.6%, 2.8%, 4.0%, 5.2%, and 9.1%, respectively. Of 62 patients, 9 were observed, 27 underwent surgical revision, 15 underwent percutaneous stent implantation, 8 received a heart transplant, and 2 died before intervention. One patient underwent surgical revision and later stent implantation. The mortality with therapeutic intervention was 9/53 (17.0%). CONCLUSIONS: Although uncommon, HM 3 LVAD-supported patients might develop eOGO with an increasing incidence after 1 year of support. Although engineering efforts to reduce this complication are under way, clinicians must maintain a focus on early detection and remain vigilant.

Left Ventricular Assist Device Implantation in Cancer-Therapy-Related Heart Failure.

OBJECTIVES: Cancer-therapy-related heart failure (CTrHF) due to cardiotoxic drugs or radiation is a growing cause of end-stage heart failure. Limited knowledge is available concerning the use of continuous-flow left-ventricular-assist devices (cfLVAD) in this setting. METHODS: The files of all 1334 patients who underwent cfLVAD implantation between December 2008 and December 2020 were screened for the cause of heart failure. All patients with CTrHF were included in the analysis. RESULTS: A total of 32 patients with a median age of 58 years (IQR: 46-65) were included in the study; 15 (47%) were male. The median time from the first diagnosis of heart failure (HF) to cfLVAD implantation was 6 months (IQR 2-24), and from cancer treatment to cfLVAD implantation 40 months (IQR 5-144). Malignancies comprised non-Hodgkin lymphoma (n = 12, 37%), breast cancer (n = 9, 28%), sarcoma (n = 5, 16%), leukemia (n = 5, 16%), and others (n = 1, 3%). In 24 patients, chemotherapy included anthracyclines (others n = 2, unknown n = 6). Chest radiation was performed in 13 patients (39%). Moreover, 71% were classified as INTERMACS profile 1 or 2. The 30-day survival rate after LVAD implantation was 88%. Rethoracotomy was necessary in nine (29%), and a temporary right ventricular assist device in seven (21%) patients. The median survival was 29 months. There was no significant difference in survival or right HF between patients with CTrHF and a matched control group. CONCLUSIONS: CfLVAD implantation is feasible in high-risk patients with CTrHF with or without prior chest radiation.

Cardiac remodeling in patients with centrifugal left ventricular assist devices assessed by serial echocardiography.

AIM: The aim of the study was to characterize the remodeling process in a large cohort of patients supported with a centrifugal left ventricular assist device (cfLVAD) by standardized serial echocardiography. METHODS AND RESULTS: From 3/2018 all cfLVAD patients underwent transthoracic echocardiography at 6 and 12 months after implantation using a standardized protocol. A total of 512 echocardiograms were reviewed (216 preoperative, 156 at 6 months, 140 at 12 months). While on cfLVAD support, left ventricular (LV) diameter decreased (p < .001). LV ejection fraction (LVEF) and LV fractional area change improved (p < .001). Potential for cfLVAD explantation (as defined by an LVEF ≥45% and opening of the aortic valve [AV]) was seen in nine patients at 6 and 21 patients at 12 months. The tricuspid annular excursion decreased significantly, while the right ventricular fractional area change did not change. Tricuspid regurgitation (TR) and mitral regurgitation (MR) improved significantly during LVAD support. Opening of the AV was seen in >64% of the patients at 6 months and in 66% at 12 months. Moderate aortic regurgitation (AR) was rare with 3.8% at 6 months but increased with the duration of cfLVAD support (8.5% at 12 months). We found no significant difference in echocardiographic parameters between patients supported with a HeartWare HVAD™ or a HeartMate 3™ device. CONCLUSION: LVAD therapy can lead to reverse LV remodeling and improvement of MR and TR. However, right ventricular function does not improve and prevalence of AR progressively increases during mechanical support.

Interventional Procedures for Left Ventricular Assist Device-Associated Complications.

As patients on long-term left ventricular assist device (LVAD) face a substantial risk for open cardiac reoperation, interventional treatment approaches are becoming increasingly important in this population. We evaluated data of 871 patients who were on LVAD support between January 1, 2016 and December 1, 2020. Interventional treatments for LVAD-associated complications were performed in 76 patients. Seventeen patients underwent transcatheter aortic valve replacements (TAVR) and 61 patients underwent outflow graft interventions (OGI). TAVR improved symptoms in patients with severe symptomatic aortic regurgitation. Postinterventional complications included aggravation of preexisting right heart failure (RHF), third-degree atrioventricular block, and intrapump thrombosis (in 3 [16.7%], 2 [11.1%], and 1 [5.6%] patients, respectively). In outflow graft obstructions, OGI led to recovery of LVAD flow ( p < 0.001), unloading of the left ventricle ( p = 0.004), decrease of aortic valve opening time ( p = 0.010), and improvement of right heart function ( p < 0.001). Complications included bleeding, RHF, and others (in 9 [10.8%], 5 [6.0%], and 5 [6.0%] patients, respectively). Eight (9.6%) patients died within the hospital stay after OGI, including mortality secondary to prolonged cardiogenic shock. In conclusion, interventional procedures are a feasible and safe treatment modality for LVAD-associated complications.

Bacteriophage therapy as a treatment option for complex cardiovascular implant infection: The German Heart Center Berlin experience.

Conventional antimicrobials have low or no activity against multidrug-resistant or chronic implant-associated infections. Lytic bacteriophages can rapidly and selectively kill bacteria, and can be combined with antibiotics. However, clinical experience of bacteriophage therapy in patients with cardiovascular infections is limited. We documented the outcome and safety of intravenous and local adjunctive bacteriophage therapy, to treat chronic relapsing cardiovascular implant infections at our institution.

Comparison of feasibility and results of frailty assessment methods prior to left ventricular assist device implantation.

AIMS: Assessing frailty and sarcopenia is considered a valuable cornerstone of perioperative risk stratification in advanced heart failure patients. The lack of an international consensus on a diagnostic standard impedes its implementation in the clinical routine. This study aimed to compare the feasibility and prognostic impact of different assessment tools in patients undergoing continuous-flow left ventricular assist device (cf-LVAD) implantation. METHODS AND RESULTS: We prospectively compared feasibility and prognostic values of six frailty/sarcopenia assessment methods in 94 patients prior to cf-LVAD implantation: bioelectrical impedance analysis (BIA), computed tomography (CT)-based measurement of two muscle areas/body surface area [erector spinae muscle (TMESA/BSA) and iliopsoas muscle (TPA/BSA)], physical performance tests [grip strength, 6 min walk test (6MWT)] and Rockwood Clinical Frailty Scale (RCFS). Six-month mortality and/or prolonged ventilation time >95 h was defined as the primary endpoint. BIA and CT showed full feasibility (100%); physical performance and RCFS was limited due to patients' clinical status (feasibility: 87% grip strength, 62% 6MWT, 88% RCFS). Phase angle derived by BIA showed the best results regarding the prognostic value for 6 month mortality and/or prolonged ventilation time >95 h (odds ratio (OR) 0.66 [95% confidence interval (CI): 0.46-0.92], P = 0.019; area under the curve (AUC) 0.65). It provided incremental value to the clinical risk assessment of EuroSCORE II: C-index of the combined model was 0.75 [95% CI; 0.651-0.848] compared with C-index of EuroSCORE II alone, which was 0.73 (95% CI: 0.633-0.835). Six-month survival was decreased in patients with reduced body cell mass derived by BIA or reduced muscle area in the CT scan compared with patients with normal values: body cell mass 65% (95% CI: 51.8-81.6%) vs. 83% (95% CI: 74.0-93.9%); P = 0.03, TMESA/BSA 65% (95% CI: 51.2-82.2%) vs. 82% (95% CI: 73.2-93.0%); P = 0.032 and TPA/BSA 66% (95% CI: 53.7-81.0%) vs. 85% (95% CI: 75.0-95.8%); P = 0.035. CONCLUSIONS: Bioelectrical impedance analysis parameters and CT measurements were shown to be suitable to predict 6-month mortality and/or prolonged ventilation time >95 h in patients with advanced heart failure prior to cf-LVAD implantation. Phase angle had the best predictive capacity and sarcopenia diagnosed by reduced body cell mass in BIA or muscle area in CT was associated with a decreased 6 month survival.

Experience with a standardized protocol to predict successful explantation of left ventricular assist devices.

OBJECTIVE: Patients with a continuous-flow left ventricular assist device may show recovery of myocardial function with unloading. Identifying candidates for and predicting clinical and hemodynamic stability after left ventricular assist device explantation remain challenging. METHODS: Retrospective analysis of patients who underwent evaluation for left ventricular assist device explantation following a standardized protocol from January 2016 to March 2020. Patients who met screening criteria underwent echocardiography under "baseline," "minimal net flow," and "pump stop" conditions. If the protocol criteria were met, right heart catheterization with left ventricular assist device stoppage and occlusion of the outflow graft with a balloon catheter were performed. In patients with pulmonary capillary wedge pressure less than 16 mm Hg, explantation was performed under "pump stop" conditions. RESULTS: A total of 544 patients were screened. Of these, 57 (10.5%) underwent a total of 73 echocardiography under "baseline" "minimal net flow" and "pump stop" conditions and 46 underwent left ventricular assist device stoppage and occlusion of the outflow graft with balloon catheter maneuvers. Complications during the procedure were rare. Ultimately, 21 patients (3.9%) underwent explantation. The left ventricular ejection fraction at baseline was 55.5% ± 6.5%. The mean pulmonary capillary wedge pressure was 8.1 ± 2.6 mm Hg and increased to 10.7 ± 2.9 mm Hg under left ventricular assist device stoppage and occlusion of the outflow graft with a balloon catheter. A nonischemic cause of cardiomyopathy was more likely to be found in patients who underwent explantation (20/21 patients [95%], P = .020). The survival 1 year after explantation was 95.2%, with 1 death occurring 222 days after left ventricular assist device explantation. At follow-up (median 24.9 months [interquartile range, 16.4-43.1 months]), patients were in New York Heart Association class 1 (61.9%), 2 (28.6%), and 3 (9.5%). CONCLUSIONS: Our 4-year experience with a standardized protocol for left ventricular assist device explantation showed a low rate of adverse events. If all criteria are met, explantation can be performed safely and with an excellent survival and functional class.

Impact of left ventricular inspection employing cardiopulmonary bypass on outcome after implantation of left ventricular assist device.

BACKGROUND: Cardiopulmonary bypass (CPB) during left ventricular assist device (LVAD) implantation provides circulatory support and allows for safe inspection of the left ventricle (LV), whereas circulatory support by veno-arterial extracorporeal life support (va-ECLS) or off-pump implantation may reduce postoperative bleeding and inflammatory response. METHODS: Retrospective analysis of 616 consecutive adult patients who received an LVAD via median sternotomy between January 1, 2015 and December 31, 2019. All patients undergoing concomitant intracardiac procedures other than closure of persistent foramen ovale or atrial septal defect and redo surgeries were excluded from the analysis. The remaining patients (n = 222) were divided into two groups and 1:1 propensity score-matched regarding preoperative parameters: patients who underwent LVAD implantation with LV inspection employing CPB (CPB group, n = 62) and without LV inspection on va-ECLS or off-pump (non-CPB group, n = 62). RESULTS: The groups were well balanced with regard to preoperative baseline characteristics (standard difference <0.1). Patients in the CPB group required more blood transfusions (median 2 vs. 0 units, p = 0.031) during surgery and in the first 24 h afterwards. The median intensive care unit stay was longer in the CPB group (18 vs. 11 days, p = 0.021). The CPB group showed an absence of perioperative stroke and a smaller number of events per patient-year for postoperative ischemic stroke (0.02 vs. 0.12, p = 0.003). 30-day survival (87% vs. 87.1%) and 1-year survival (80.3% vs. 74%) were similar in both groups (p = 0.78). CONCLUSION: Visual LV inspection on CPB may reduce the risk of postoperative ischemic stroke. Despite the negative effects of employing CPB in lieu of other intraoperative strategies, survival was similar in both groups.

Development of tricuspid regurgitation and right ventricular performance after implantation of centrifugal left ventricular assist devices.

BACKGROUND: Tricuspid regurgitation (TR) after left ventricular assist device (LVAD) implantation is associated with a poor prognosis. This study evaluates the development of TR and right ventricular (RV) performance after LVAD implantation. METHODS: Retrospective analysis of patients who underwent LVAD implantation between March 2018 and June 2019. Patients who underwent concomitant tricuspid valve surgery and patients with congenital heart disease were excluded. RESULTS: A total of 155 patients underwent LVAD implantation. Fourteen patients were excluded. Of the remaining patients, thirty-one died during the first six months, six were lost to follow-up and two underwent transplantation. 102 patients presented at 6.3 months (5.8 to 7.0). Patients were supported with HeartWare HVAD (74%) or HeartMate 3 (26%). 50.4% were rated as INTERMACS profile 1 or 2. At six months, systolic pulmonary artery pressure dropped from 36 to 21 mmHg (P<0.001). Tricuspid annular plane systolic excursion decreased from 17.3 to 14.3 mm (P<0.001), RV fractional area change did not change (P=0.839). Twenty-two patients (22%) presented with moderate-to-severe or severe (ms-s) TR pre-operatively. Of these, eighteen (81%) showed improvement to ≤ moderate TR. At follow-up twelve patients presented with ms-s TR. Of these, only four patients (33%) had been diagnosed with ms-s TR pre-operatively. There were no differences in pre-operative echocardiographic or clinical parameters between the twelve patients with ms-s late TR and the other ninety patients in the cohort. CONCLUSIONS: TR can show an impressive improvement with LVAD support. Longitudinal RV function decreases; this appears to be compensated by transverse shortening. Late TR can develop independently from pre-operative parameters including TR.

Safety of Contemporary Heart Failure Therapy in Patients with Continuous-Flow Left Ventricular Assist Devices.

BACKGROUND: Limited data are available concerning the safety, optimal administration and benefits of contemporary heart failure therapy in patients after left ventricular assist device (LVAD) implantation. METHODS: Between 2015 and 2019, 257 patients underwent LVAD implantation and were included in this observational study. Oral heart failure therapy was initiated and uptitrated during the further course. After propensity matching and excluding patients with immediate postoperative treatment in an affiliated center with different medical standards, hospitalization rates and mortality within 12 months after LVAD implantation were compared between 83 patients who received medical therapy including an angiotensin receptor neprilysin inhibitor (ARNI) and 83 patients who did not receive an ARNI. RESULTS: The overall use of heart-failure medications after 12 months was high: prescriptions: beta-blockers, 85%; angiotensin inhibiting drugs, 90% (angiotensin-converting-enzyme inhibitors 30%, angiotensin receptor blockers 23%, ARNI 37%); mineralocorticoid receptor antagonists, 80%. No serious drug-related adverse events occurred. The conditional 1-year survival in the group with ARNIs was 97% (95% CI: 94%-100%) compared to 88% in the group without an ARNI (95% CI: 80%-96%); P = 0.06. CONCLUSIONS: Contemporary heart failure therapy is safe in patients with LVADs. No increase in serious adverse events was seen in patients receiving ARNIs. No significant difference in the conditional 1-year survival was seen between the ARNI group and the nonARNI group.

Durable mechanical circulatory support in patients with heart failure with preserved ejection fraction.

Only few patients with heart failure with preserved ejection fraction undergo durable mechanical circulatory support implantation. We identified three patients with heart failure with preserved ejection fraction who needed durable mechanical circulatory support as bridge-to-transplant therapy. In two patients with hypertrophic cardiomyopathy, the hypertrophic papillary muscles and myocardium were resected to allow for subsequent left ventricular assist device implantation. In one patient, all visible parts of the mitral valve were additionally resected. The third patient with restrictive cardiomyopathy underwent Berlin Heart Excor BVAD implantation with left atrial cannulation.

Diagnosis and Treatment Strategies of Outflow Graft Obstruction in the Fully Magnetically Levitated Continuous-Flow centrifugal Left Ventricular Assist Device: A Multicenter Case Series.

Outflow graft obstruction in left ventricular assist devices (LVADs) is a rare complication whose clinical presentation may be subtle. We present six cases of outflow graft obstruction in patients on HeartMate 3 LVAD detected between 648 and 1,222 days on support. Detection principles are described and treatment strategies discussed. Three patients were successfully managed with stents, one underwent surgical revision, one patient died despite emergency treatment, and the last patient without symptoms was listed for heart transplantation.

Prediction of survival of patients in cardiogenic shock treated by surgically implanted Impella 5+ short-term left ventricular assist device.

OBJECTIVES: Short-term mechanical circulatory support is a life-saving treatment for acute cardiogenic shock (CS). This multicentre study investigates the preoperative predictors of 30-day mortality in CS patients treated with Impella 5.0 and 5.5 short-term left ventricular assist devices. METHODS: Data of patients in CS (n = 70) treated with the Impella 5 (n = 63) and 5.5 (n = 7) in 2 centres in Berlin between October 2016 and October 2019 were collected retrospectively. RESULTS: CS was caused by acute myocardial infarction (n = 16), decompensated chronic heart failure (n = 41), postcardiotomy syndrome (n = 5) and acute myocarditis (n = 8). Before implantation 12 (17%) patients underwent cardiopulmonary resuscitation and 32 (46%) patients were ventilated. INTERMACS level 1, 2 and 3 was established in 35 (50%), 29 (41%) and 6 (9%) of patients, respectively. The mean preoperative lactate level was 4.05 mmol/l. The median support time was 7 days (IR= 4-15). In 18 cases, the pump was removed for myocardial recovery, in 22 cases, durable left ventricular assist devices were implanted, and 30 patients died on support. The overall 30-day survival was 51%. Statistical analysis showed that an increase in lactate per mmol/l [odds ratio (OR) 1.217; P = 0.015] and cardiopulmonary resuscitation before implantation (OR 16.74; P = 0.009) are predictors of 30-day survival. Based on these data, an algorithm for optimal short-term mechanical circulatory support selection is proposed. CONCLUSIONS: Impella treatment is feasible in severe CS. Severe organ dysfunction, as well as the level and duration of shock predict early mortality. An algorithm based on these parameters may help identify patients who would benefit from Impella 5+ support.

Safety of bioelectrical impedance analysis in advanced heart failure patients.

BACKGROUND: Cardiac cachexia and frailty are major complications of advanced heart failure (AHF). Bioelectrical impedance analysis (BIA) may provide valuable information regarding fluid balance, muscle mass and prognosis. The main concerns regarding the use of BIA in AHF patients remain arrhythmias and electromagnetic interferences with cardiac implantable electronic devices (CIEDs). Reliable data regarding patients on continuous-flow ventricular assist device (cf-VAD) remain scarce. The aim of this study is to evaluate the safety of BIA in AHF patients on pro-arrhythmogenic therapy with an implanted CIED and/or with a cf-VAD. METHODS: We prospectively performed 217 BIA measurements in 143 AHF patients at risk of severe arrhythmias due to inotropic support/a history of ventricular arrhythmias and/or treated with CIED, including 104 patients with an ICD, CRT or pacemaker and 95 patients with a cf-VAD. All patients were under continuous Electrocardiogram (ECG) monitoring and clinical surveillance for 24 hours. RESULTS: No adverse events were observed during the 217 BIA measurements: No rhythm disturbances were documented in the telemetric monitoring during or within 30 minutes after the measurement. CIEDs showed no malfunction, regardless of the location measured or the device manufacturer. In particular, no inappropriate shocks were observed. No alarms, flow disturbances, or malfunctions of the cf-VAD occurred during or after the measurements. CONCLUSION: We consider BIA a safe measurement with major clinical relevance in our cohort of AHF patients, despite an increased arrhythmic potential on inotropic support or the presence of implanted electronic devices (ICD, CRT, pacemaker and cf-VAD).