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.

Supervised exercise training in patients with advanced heart failure and left ventricular assist device: A multicentre randomized controlled trial (Ex-VAD trial).

AIMS: Small studies and observations suggested that exercise training may improve peak oxygen consumption (peakVO2 ) in patients with advanced heart failure and left ventricular assist device (LVAD). We investigated whether in this patient group a supervised exercise training can improve exercise capacity. METHODS AND RESULTS: In this multicentre, prospective, randomized, controlled trial, patients with stable heart failure and LVAD were randomly assigned (2:1) to 12 weeks of supervised exercise training or usual care, with 12 weeks of follow-up. The primary endpoint was the change in peakVO2 after 12 weeks (51 patients provided a power of 90% with an expected group difference in peakVO2 of 3 ml/kg/min). Secondary endpoints included changes in submaximal exercise capacity and quality of life. Among 64 patients enrolled (97% male, mean age 56 years), 54 were included in the analysis. Mean difference in the change of peakVO2 after 12 weeks was 0.826 ml/min/kg (95% confidence interval [CI] -0.37, 2.03; p = 0.183). There was a positive effect of exercise training on 6-min walk distance with a mean increase in the intervention group by 43.4 m (95% CI 16.9, 69.9; p = 0.0024), and on the Kansas City Cardiomyopathy Questionnaire physical domain score (mean 14.3, 95% CI 3.7, 24.9; p = 0.0124), both after 12 weeks. The overall adherence was high (71%), and there were no differences in adverse events between groups. CONCLUSION: In patients with advanced heart failure and LVAD, 12 weeks of exercise training did not improve peakVO2 but demonstrated positive effects on submaximal exercise capacity and physical quality of life.

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.

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.

Six years of continuous mechanical circulatory support following chronic graft failure.

Re-transplantation is the preferred treatment for patients with chronic heart transplant failure. If re-transplantation is not a viable option due to the patient's comorbidities, left ventricle assist device can be used as the destination treatment. An interdisciplinary approach with thorough follow-up can help in the early detection and treatment of complications associated with LVAD.

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.

Lived experiences of patients implanted with left ventricular assist devices.

BACKGROUND: Besides survival, improvement in quality of life (QoL) is a major aim of left ventricular assist device (LVAD) implantation. QoL assessment tools in current use are effective in the gathering of standardized metrics but are limited in their ability to elucidate everyday lived patient experiences that also affect overall patient wellbeing. OBJECTIVE: To describe and understand the lived experiences of patients undergoing long-term circulatory support with LVAD. METHODS: A phenomenological approach was used. Purposive sampling of consecutive willing inpatients and outpatients living with an LVAD for longer than 6 months was conducted until theme saturation. There were a total of 21 patients interviewed and this was then recorded and transcribed. RESULTS: A total of eight themes emerged from the data. Overall, the patients' quality of life was affected by: (1) whether they had experienced improvements or setbacks in their recent health condition, (2) experiencing burdens from their device such as weight and handling, (3) limitations in their physical ability such as participating in sports, their inability to work; or reduced sleep, (4) reduced social interactions; (5) reduction in sexual activity and performance; (6) experiencing emotional and psychological problems and experiencing anxiety. Patients highlighted the value of obtaining (7) support from family and friends. The interviews also revealed that some patients experienced the feeling of (8) optimism and obtaining "a second chance" at life. CONCLUSIONS: LVAD patients have unique concerns and lived experiences. Some themes emerging from this interview series such as having to give up work, having reduced social contact, reduced sexual activity and emotional problems, family support structures demand careful attention during the pre-implantation counselling and post implantation ongoing care. These aspects also deserve more attention in quality of life studies among LVAD patients. Patients with recent improvements in health reported a more positive outlook. Overall the majority of patients reported feeling that they obtained a second chance at life.

Predictive Value of Two-Dimensional Speckle-Tracking Echocardiography in Patients Undergoing Surgical Ventricular Restoration.

Objectives: Parameters of left ventricular (LV) mechanics, obtained from speckle-tracking echocardiography (STE), were found to be of prognostic value in patients with heart failure and those who underwent cardiac surgery. This study aimed to assess the value of STE in patients scheduled to undergo surgical ventricular restoration (SVR). Methods: A total of 158 consecutive patients with baseline STE who underwent SVR due to an LV anteroapical aneurysm were included in the analysis. Preoperative longitudinal STE parameters were evaluated for their association with an outcome, defined as all-cause mortality, LV assist device implantation, or heart transplantation. The echocardiographic follow-up to assess the change in the regional function of the segments remote from the aneurysm was performed in 43 patients at a median of 10 months [interquartile range (IQR): 6-12.7 months] after SVR. Results: During a median follow-up of 5.1 years (IQR: 1.6-8.7 years), events occurred in 68 patients (48%). Less impaired mean basal end-systolic longitudinal strain (BLS) with a cutoff value ≤ -10.1 % demonstrated a strong association with event-free survival, also in patients with an LV shape corresponding to an intermediate shape between aneurysmal and globally akinetic. Initially hypo- or akinetic basal segments with preoperative end-systolic strain ≤ -7.8% showed a greater improvement in wall motion at the short-term follow up. Conclusion: Patients with less impaired preoperative BLS exhibited a better event-free survival after SVR, also those with severe LV remodeling. The preserved preoperative segmental longitudinal strain was associated with a greater improvement in regional wall motion after SVR. BLS assessment may play a predictive role in patients with an LV anteroapical aneurysm who are scheduled to undergo SVR.

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.

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 Muscle Mass as a Prognostic Factor for Failed Waiting Time Prior to Heart Transplantation.

Objectives: Clinical deterioration during the waiting time impairs the prognosis of patients listed for heart transplantation. Reduced muscle mass increases the risk for mortality after cardiac surgery, but its impact on resilience against deterioration during the waiting time remains unclear. Methods: We retrospectively analyzed data from 93 patients without a VAD who were listed in Eurotransplant status "high urgent (HU)" for heart transplantation between January 2015 and October 2020. The axial muscle area of the erector spinae muscles at the level of thoracic vertebra 12 indexed to body surface area (TMESA/BSA) measured in the preoperative thoracic computed tomography scan was used to measure muscle mass. Results: Forty patients (43%) underwent emergency VAD implantation during the waiting time and four patients (4%) died during the waiting time. The risk of emergency VAD implantation/death during the waiting time decreased by 10% for every cm2/m2 increase in muscle area [OR 0.901 (95% CI: 0.808-0.996); p = 0.049]. After adjusting for gender [OR 0.318 (95% CI: 0.087-1.073); p = 0.072], mean pulmonary artery pressure [OR 1.061 (95% CI: 0.999-1.131); p = 0.060], C-reactive protein [OR 1.352 (95% CI: 0.986-2.027); p = 0.096], and hemoglobin [OR 0.862 (95% CI: 0.618-1.177); p = 0.360], TMESA/BSA [OR 0.815 (95% CI: 0.698-0.936); p = 0.006] remained an independent risk factor for emergency VAD implantation/death during the HU waiting time. Conclusion: Muscle area of the erector spinae muscle appears to be a potential, easily identifiable risk factor for emergency VAD implantation or death in patients on the HU waiting list for heart transplantation. Identifying patients at risk could help optimize the outcome and the timing of VAD support.

Diagnostic and Prognostic Value of a TDI-Derived Systolic Wall Motion Analysis as a Screening Modality for Allograft Rejection after Heart Transplantation.

BACKGROUND: Despite the risk for complications, allograft surveillance after orthotopic heart transplantation (OHT) is performed by cardiac catheterization and biopsies. We investigated the diagnostic and prognostic value of a TDI-derived systolic wall motion analysis of the posterobasal wall of the left ventricle (Sm) as a screening modality in OHT aftercare. METHODS: We examined data of 210 eligible patients who underwent OHT between 2010 and 2020. Forty-four patients who had died within the initial hospital stay were excluded. For 166 patients, baseline and follow-up data were analyzed. The mean age at OHT was 46.2 (±11.4) years; 76.5% were male. RESULTS: Within the observational period, 22 (13.3%) patients died. In total, 170 episodes of acute cellular or humoral rejections occurred (84 ISHLT1R; 13 ISHLT2R; 8 ISHLT3R; 65 AMR), and 29 catheterizations revealed cardiac allograft vasculopathy (5 CAV1; 4 CAV2; 20 CAV3). Individual Sm radial/longitudinal remained stable within the follow-up period (11.5 ± 2.2 cm/s; 10.9 ± 2.1 cm/s). Patients with acute rejections and CAV3 showed significant Sm radial/longitudinal reductions (AMR1: 1.6 ± 1.9 cm/s, confidence interval (CI) 0.77-0.243, p < 0.001; 1.8 ± 2.0 cm/s, CI 0.92-0.267, p < 0.001. ISHLT1R: 1.7 ± 1.8 cm/s, CI 1.32-2.08, p < 0.001; 2.0 ± 1.6 cm/s, CI 1.66-2.34, p < 0.001. CAV3: 1.3 ± 2.5 cm/s, CI 0.23-2.43, p < 0.017; 1.4 ± 2.8 cm/s, CI 0.21-2.66, p < 0.021). Lower Sm was associated with a threefold increase in all-cause mortality (hazard ratio (HR) 3.24, CI 1.2-8.76, p = 0.020; HR 2.92, CI 1.19-7.18, p = 0.019). Overall, Sm-triggered surveillance led to 0.75 invasive diagnostics per patient post-OHT year. CONCLUSIONS: Sm remained stable in the post-OHT course. Reductions indicated ISHLT1R, AMR1 and CAV3 and were associated with higher all-cause mortality. Sm-triggered surveillance may be referred to as a safe, high-yield screening modality in OHT aftercare.

Myocardial Work Assessment for the Prediction of Prognosis in Advanced Heart Failure.

Objectives: The aim of this study was to investigate whether echocardiographic assessment of myocardial work is a predictor of outcome in advanced heart failure. Background: Global work index (GWI) and global constructive work (GCW) are calculated by means of speckle tracking, blood pressure measurement, and a normalized reference curve. Their prognostic value in advanced heart failure is unknown. Methods: Cardiopulmonary exercise testing and echocardiography with assessment of GWI and GCW was performed in patients with advanced heart failure caused by ischemic heart disease or dilated cardiomyopathy (n = 105). They were then followed up repeatedly. The combined endpoint was all-cause death, implantation of a left ventricular assist device, or heart transplantation. Results: The median patient age was 54 years (interquartile range [IQR]: 48-59.9). The mean left ventricular ejection fraction was 27.8 ± 8.2%, the median NT-proBNP was 1,210 pg/ml (IQR: 435-3,696). The mean GWI was 603 ± 329 mmHg% and the mean GCW was 742 ± 363 mmHg%. The correlation between peak oxygen uptake and GWI as well as GCW was strongest in patients with ischemic cardiomyopathy (r = 0.56, p = 0.001 and r = 0.53, p = 0.001, respectively). The median follow-up was 16 months (IQR: 12-18.5). Thirty one patients met the combined endpoint: Four patients died, eight underwent transplantation, and 19 underwent implantation of a left ventricular assist device. In the multivariate Cox regression analysis, only NYHA class, NT-proBNP and GWI (hazard ratio [HR] for every 50 mmHg%: 0.85; 95% CI: 0.77-0.94; p = 0.002) as well as GCW (HR for every 50 mmHg%: 0.86; 95% CI: 0.79-0.94; p = 0.001) were identified as independent predictors of the endpoint. The cut-off value for predicting the outcome was 455 mmHg% for GWI (AUC: 0.80; p < 0.0001; sensitivity 77.4%; specificity 71.6%) and 530 mmHg% for GCW (AUC: 0.80; p < 0.0001; sensitivity 74.2%; specificity 78.4%). Conclusions: GWI and GCW are powerful predictors of outcome in patients with advanced heart failure.

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.

Feasibility of two-dimensional speckle-tracking echocardiography of aortic valve in patients with calcific aortic valve disease.

Calcific aortic valve (AV) disease is associated with increased stiffness and reduced motion of AV leaflets, has a progressive course, and can develop into aortic stenosis (AS). Our aim was to evaluate whether two-dimensional speckle-tracking echocardiography (STE) may be used for the assessment of AV stiffness. We applied STE to AV leaflets in patients with various degrees of degenerative changes of AV and measured strain as an absolute value of the radial deformation of AV leaflets. Deformation of AV expressed as averaged AV strain was greatest in patients with a normal AV (23.4 ± 6.4%), compared to those with aortic sclerosis (12.9 ± 3.2%), moderate-to-severe AS (11.9 ± 4%), and severe AS (10.9 ± 3.5%) (p < 0.01). A non-linear relationship and moderate correlation of AV strain with transvalvular hemodynamic parameters was observed. In patients with mild-to-moderate AS, the strain of AV leaflets also correlated negatively with AV calcification (r = -0.59, p = 0.008). Good inter-observer agreement was obtained for averaged AV strain with a coefficient of variation of 0.15 and an interclass correlation coefficient of 0.94 (p < 0.0001). In this study we demonstrated that deformation of AV leaflets as assessed by STE might be a potential method for a non-invasive evaluation of AV biomechanical properties and of the progression of calcific aortic disease. Further development of the two-dimensional speckle tracking technique specifically for valve structures is needed to enable a better quantification of leaflet deformation.

Assessment of 10-Year Left-Ventricular-Remodeling by CMR in Patients Following Aortic Valve Replacement.

Aims: Aortic valve replacement (AVR) may result in reverse cardiac remodeling. We aimed to assess long-term changes in the myocardium following AVR by Cardiac Magnetic Resonance Imaging (CMR). Methods: We prospectively observed the long-term left ventricular (LV) function and structure of 27 patients with AVR [n = 19 with aortic stenosis (AS); n = 8 with aortic regurgitation (AR)] by CMR. Patients underwent CMR before, as well as 1, 5, and 10 years after AVR. We evaluated clinical parameters, LV volumes, mass, geometry, ejection fraction (EF), global myocardial longitudinal strain (MyoGLS), global myocardial circular strain (MyoGCS), hemodynamic forces (HemForces), and Late Gadolinium Enhancement (LGE). Results: The median of LVMI, EDVI, and ESVI decreased in both groups. Patients with AR had higher initial values of EDVI and ESVI and showed a more prominent initial reduction. In AS, MyoGLS improved already after 1 year and remained constant afterward, whereas, in AR no improvement of MyoGLS was found. MyoGCS remained unchanged in the AS group but deteriorated in the AR group over 10 years. Ejection fraction (EF) was higher in AS patients compared to AR 10 years post-AVR. Late gadolinium enhancement (LGE) could be found more frequently in AS patients. Conclusion: CMR was well suited to investigate myocardial changes over a 10-year follow up period in patients with aortic valve disease. Regarding the long-term functional changes following AVR, patients with AR seemed to benefit less from AVR compared to AS patients. Fibrosis was more common in AS, but this did not reflect functional evolution in these patients. Close monitoring seems indispensable to avoid irreversible structural damage of the heart and to perform AVR at an appropriate stage.

Echocardiographic assessment of mitral regurgitation: discussion of practical and methodologic aspects of severity quantification to improve diagnostic conclusiveness.

The echocardiographic assessment of mitral valve regurgitation (MR) by characterizing specific morphological features and grading its severity is still challenging. Analysis of MR etiology is necessary to clarify the underlying pathological mechanism of the valvular defect. Severity of mitral regurgitation is often quantified based on semi-quantitative parameters. However, incongruent findings and/or interpretations of regurgitation severity are frequently observed. This proposal seeks to offer practical support to overcome these obstacles by offering a standardized workflow, an easy means to identify non-severe mitral regurgitation, and by focusing on the quantitative approach with calculation of the individual regurgitant fraction. This work also indicates main methodological problems of semi-quantitative parameters when evaluating MR severity and offers appropriateness criteria for their use. It addresses the diagnostic importance of left-ventricular wall thickness, left-ventricular and left atrial volumes in relation to disease progression, and disease-related complaints to improve interpretation of echocardiographic findings. Finally, it highlights the conditions influencing the MR dynamics during echocardiographic examination. These considerations allow a reproducible, verifiable, and transparent in-depth echocardiographic evaluation of MR patients ensuring consistent haemodynamic plausibility of echocardiographic results.