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The edge-to-edge mitral valve repair technique, invented by Alfieri and colleagues, introduced valve repair as a treatment option for patients with complex diseases where standard annuloplasty and related repair techniques are insufficient, due to annular calcification and patient frailty. We retrospectively evaluated the results of a transaortic edge-to-edge mitral valve repair (Alfieri stitch) in high-risk patients who were undergoing aortic valve replacement. From February, 2012 to December, 2017, 43 patients underwent transaortic edge-to-edge mitral valve repair with concomitant aortic valve replacement at a single institution. Preoperative and postoperative echocardiograms were compared. Home telephone follow up was conducted and postoperative morbidity was examined, including the need for reoperation, stroke and cardiac arrhythmia. 30-day and long-term survival rates were also determined. Mitral regurgitation (MR) was graded semi-quantitatively as 0 (trace and/or none), mild (1), moderate (2) or moderate to severe (3-4). The patients were 74 ± 7.8 years old. 65% of the patients were male. Mean cardiopulmonary bypass time was 115 ± 37 minutes and mean cross-clamp time was 71 ± 23 minutes. There was a significant improvement in preoperative vs postoperative median MR grade (2 (IQR 2-3) vs 0 (IQR 0-1); P = 0.05). Follow-up transthoracic echocardiograms in 29 patients obtained at a median of 9 months' (range 3 - 19 months') and in 16 patients at a median of 34 months' postoperatively (range 21 - 53 months') showed mild (1 (IQR 1-2)) grade of mitral regurgitation. 30-day survival was 98%. Long term survival at 12 and 24 months' were 88% and 81% respectively. Mitral valve reoperation was conducted in 1 patient (2%), who was suffering of endocarditis. Stroke occurred in 2 patients (7%). Cardiac arrhythmia was observed in 15 patients (35%). 8 patients (19%) suffered from atrial fibrillation and 7 patients (16%) displayed atrioventricular blockage. 10 patients (23%) could be treated conservatively and 5 patients (12%) needed implantation of a pacemaker. Transaortic edge-to-edge mitral valve repair can be safely performed during aortic valve replacement in high-risk patients and improves even long-term MR grade. Postoperative cardiac arrhythmia occurs frequently. 66% of them could be treated successfully by conservative procedures.

Coronavirus disease 2019 (COVID-19) radically modified the organization of healthcare systems with shutdown of routine activities and outpatient clinics. Herein, we report our institutional experience with a Telemonitoring and Care Program (TC-Program) to monitor and support left ventricular assist device (LVAD) patients during COVID-19 outbreak. This single-arm cohort study analyzed 156 patients who entered the TC-Program at our institution between April and August 2020. The TC-Program was based on routine phone calls to patients and a 24/7 emergency line. In November 2020, patients were asked for feedback on the TC-Program and checked for survival, transplant, or explant. The primary endpoint was the rate of TC-Program-driven interventions. Patients (males: 82.8%) were 61 years old (interquartile range [IQR]: 53.0-67.5) and on LVAD support for 1,266 days (IQR: 475-2,211). Patients were included in the TC-Program for a median time of 99 days (min:15, max:120) and received a median number of six phone calls (min:1, max:14). Twenty-three patients (14.7%) were referred for clinical evaluation after phone contact. Two patients (1.27%) were diagnosed with COVID-19: one of them died after intensive care, and one remained paucisymptomatic and recovered. Three patients asked to exit the program considering it not useful while the others gave high rates in terms of usefulness (median: 9, IQR: 8-10), information (median: 9, IQR: 8-10), good medical care (median: 9, IQR: 8-10), and psychologic support (median: 8, IQR: 7-10). A TC-Program based on the four ICSA principles (Inform, Care, Support, and Adapt) is feasible in LVAD patients and can be rapidly implemented during the COVID-19 pandemic.

Objective A growing number of patients suffering from heart failure is living with a left ventricular assist device (LVAD) and is in the need for non-cardiac surgery. Vascular procedures due to ischemia, bleeding, or other device-related complications may be required and pose a challenge to the caregivers in terms of monitoring and management of these patients. Therefore, we reviewed our experience with LVAD patients undergoing vascular surgery. Methods From January 2010 until March 2017, a total of 54 vascular procedures were performed on 41 LVAD patients at our institution. Patient records were reviewed retrospectively in terms of incidence of LVAD-related complications, including thrombosis, stroke, bleeding, wound healing, and survival associated with vascular surgery. The type of surgery was recorded, as well as various clinical demographic variables. Results Vascular procedures were performed in 35 men (85.4%) and 6 women (14.6%) with LVADs. There were no perioperative strokes, device thromboses, or device malfunctions. Thirty-day mortality overall was 26.8% (eleven patients), with most patients dying within 30 days after LVAD implantation due to multi-organ failure. In 25 procedures (46.3%), a blood transfusion was necessary. Conclusion Patients on LVAD support are a complex cohort with a high risk for perioperative complications. In a setting where device function and anticoagulation are monitored closely, vascular surgery in these patients is feasible with an acceptable perioperative risk.

An intra-cavitary left ventricular (LV) thrombus is a relative contraindication to LV assist device (LVAD) implantation based on increased thromboembolic risks. Herein, we present our experience with LVAD patients with or without preoperative diagnosis of LV-thrombus. We retrospectively investigated 563 patients who received LVAD implantation between 2004 and 2018. Diagnosis of LV-thrombus was verified with computed tomography scan, magnetic resonance imaging, echocardiography, or intraoperative LV inspection. The primary endpoint was 30-day survival free of stroke and pump thrombosis. Overall, 72 patients (12.8%) had a diagnosis of LV-thrombus. They were younger (51 years; IQR:41-59), affected by severely reduced ejection fraction (15%; IQR:10-20), more often presenting with dilated cardiomyopathy (61.8%) and INTERMACS profile 1 (33.3%). Preoperative atrial fibrillation was frequent in patients without LV-thrombus (38.9%). Conventional sternotomy was the preferred approach in LV-thrombus patients (77.8%), based on more HMII implantations in these patients (41.7%). Survival free of strokes and pump thrombosis at 30 days was comparable (P = .5751) between patients with (83.3%) or without LV-thrombus (80.9%). LVAD implantation in patients with preoperative LV-thrombus is safe and feasible. When managed through correct diagnostic and intraoperative strategies including accurate inspection of the LV cavity, these patients show similar 30-day outcomes compared to patients without LV-thrombus.

Aims Most devices for treating ambulatory Class II and III heart failure are linked to electrical pulses. However, a steady electric potential gradient is also necessary for appropriate myocardial performance and may be disturbed by structural heart diseases. We investigated whether chronic application of electrical microcurrent to the heart is feasible and safe and improves cardiac performance. The results of this study should provide guidance for the design of a two‐arm, randomized, controlled Phase II trial. Methods and results This single‐arm, non‐randomized pilot study involved 10 patients (9 men; mean age, 62 ± 12 years) at two sites with 6 month follow‐up. All patients had New York Heart Association (NYHA) Class III heart failure and non‐ischaemic dilated cardiomyopathy, with left ventricular ejection fraction (LVEF)

OBJECTIVES The HeartMate 3 left ventricular assist device was first implanted in 2014 and received the Conformité Européenne mark in 2015. Since then, several trials demonstrated its high haemocompatibility associated with good survival and low adverse events rates. Herein, we report our institutional experience with patients supported with HeartMate 3 for 5 years. METHODS This prospective cohort study included patients receiving a HeartMate 3 implantation in 2014 as part of the HeartMate 3 Conformité Européenne Mark clinical trial. Patients had follow-up visits every 3 months while on left ventricular assist device support, and all patients completed the 5-year follow-up. The primary end point was survival at 5 years. Secondary end points included adverse events, health status and quality of life. RESULTS Eight patients (men: 75%) aged 59 years (min–max: 52–66 years) were enrolled. At 5 years, survival was 100%. Patients remained on support for a median time of 1825 days (min–max: 101–1825 days); 2 patients successfully received cardiac transplants. No right heart failure, haemolysis, pump thrombosis, pump malfunction or neurological events occurred in any patients. A driveline infection was observed in 6 patients (0.25 events/patient-year). Compared to baseline, a significant improvement in quality of life and in New York Heart Association functional class was noted after the implant and for the whole follow-up time. A slight decline in kidney function and in the 6-min walk test results occurred after 3 years. CONCLUSIONS This study reports the longest single-centre follow-up of the HeartMate 3, showing excellent haemocompatibility over time with high survival and low complication rates at 5 years.

Irreversible, end-stage biventricular heart failure is associated with mortality rates of up to 100%. Despite the increasing application of ventricular assist devices (VADs), many centers lack experience with total artificial heart (TAH) implantation techniques. We present a surgical technique consisting of the implantation of 2 HeartMate 3 VADs in the setting of a TAH as a bridge to transplantation strategy.

Literature on the air travel activities of patients supported by permanent mechanical assist devices is rare. To the best of our knowledge, no air travel guidelines or fitness prerequisites exist on whether and when ventricular assist device (VAD) patients are allowed to travel by plane after device implantation. In this study, we evaluated the topic of air travel after VAD implantation. This working group aimed to produce a report on air travel passengers supported by VADs, regarding their fitness to fly. Fifty left ventricular assist device (LVAD) patients were surveyed in a worldwide multicenter study. The single survey was performed with a multimethod design, including interviews conducted face‐to‐face, online, and on phone. Out of 50 patients, 97% described their traveling by aircraft as perfect and uneventful during the flight. Eighty‐five percent of the study participants consulted their medical practitioner before the flight. No patient reported the occurrence of a severe condition associated with flying. LVAD alarms, especially low flow alarms, did not occur in any of the devices. Thirty‐five percent of the surveyed patients, however, stated a major problem pertaining to the security check procedures at the airport. The results of this study suggest that commercial air travel is safe for stable patients on permanent VAD support and traveling can be resumed securely after VAD implantation. Conscientious preparation by packing necessary devices, fluids, medications, and careful preparation for the airport security check is recommended.

Background: Cardiogenic shock occurs in 10%-15% of patients with Takotsubo syndrome (TS). For several reasons catecholamines, and especially inotropes, should be avoided in TS. Temporary mechanical circulatory support (MCS) appears attractive as bridge-to-recovery, but prospective studies are lacking. Here we analyze the available literature on MCS use in patients with TS. Methods and results: PubMed/Medline was systematically screened until December 2019. 18 studies reporting pooled data of 5629 TS patients, of whom 227 had received MCS, were considered for a qualitative synthesis. 81 articles from 2003 through 2019 reporting individual data of 93 MCS cases were included in a meta-analysis. Median age was 57 (IQR: 43-68) years, 83.9% were women, and a physical trigger could be identified in 74.1% of cases. Median left ventricular ejection fraction (LVEF) before MCS was 20% (IQR: 15-25) and comparable between groups defined by MCS device. An apical TS type was present in 76.1% of cases. The overall number of publications on MCS for TS increased over time, as did those using veno-arterial extracorporeal membrane oxygenation (V-A ECMO) and Impella, while those using intra-aortic balloon pump declined. MCS-related complications were not regularly reported. Median time on MCS was 3 (IQR: 2-7) days, with an overall survival of 94.6%. Conclusions: MCS for TS-related shock is increasingly reported, with a growing use of V-A ECMO and Impella. Currently available clinical data support this approach. Prospective studies are needed to evaluate safety and efficacy of different devices as well as timing of MCS in this special patient population. (C) 2020 Elsevier B.V. All rights reserved.

Purpose The subcutaneous implantable cardioverter-defibrillator (S-ICD) could be a promising alternative to the conventional transvenous ICD in patients with LVAD due to its reduced risk of infection. However, surface ECG is altered following LVAD implantation and, since S-ICD detection is based on surface ECG, S-ICD could be potentially affected. The aim of the present study was to analyze S-ICD eligibility in patients with LVAD. Methods Seventy-five patients implanted with an LVAD were included in this prospective single-center study. The ECG-based screening test and the automated screening test were performed in all patients. Results Fifty-five (73.3%) patients had either a positive ECG-based or automated screening test. Out of these, 28 (37.3%) patients were found eligible for S-ICD implantation with both screening tests performed. ECG-based screening test was positive in 50 (66.6%) patients; automated screening test was positive in 33 (44.0%) patients. Three ECG-based screening tests could not be evaluated due to artifacts. With the automated screening test, in 9 (12.0%) patients, the test yielded no result. Conclusions Patients implanted with an LVAD showed lower S-ICD eligibility rates compared with patients without LVAD. With an S-ICD eligibility rate of maximal 73.3%, S-ICD therapy may be a feasible option in these patients. Nevertheless, S-ICD implantation should be carefully weighed against potential device-device interference. Prospective studies regarding S-ICD eligibility before and after LVAD implantation are required to further elucidate the role of S-ICD therapy in this population.

In patients with a continuous-flow left ventricular assist device, preimplant predictors of poor physical performance are not well-described. We aimed to identify predictors of inability to walk more than 300 m on 6-minute walk test (6MWT) 6 months after HeartMate 3 implantation.Using data from the European Registry of Patients Implanted With a Full Magnetically Levitated LVAD, patients with available 6MWT at 6 months after implantation were included (N = 194) and grouped according to 6MWT distance (6MWD) of300 m (n = 150) or 6MWD of300 m (n = 44). Patients walking300 m were older (60 ± 10 vs 52 ± 12 years; P.001), more often New York Heart Association functional class IV (63% vs 42%; P = .03), and more often had type 2 diabetes (43% vs 17%; P.001) at implantation. Atrial fibrillation was seen in 57% in those with a 6MWT of300 m vs 31% in those walking longer (P.002). Further, hemoglobin and estimated glomerular filtration rate was lower in those walking300 m (both P.01). In multivariable regression analysis, independent predictors of a 6MWD of300 m were: atrial fibrillation (odds ratio [OR], 3.22; 95% confidence interval [CI], 1.12-8.67), older age (OR for 10-year increment, 2.81; 95% CI, 1.55-5.07), New York Heart Association functional class IV (OR, 3.37; 95% CI, 1.27-8.98), and Interagency Registry for Mechanically Assisted Circulatory Support profile 1 or 2 (OR, 6.53; 95% CI, 1.92-22.19).Six months after HeartMate 3 implantation, 77% of patients walked300 meters in 6 minutes. Apart from age and measures of heart failure severity, atrial fibrillation at implantation is an independent predictor of low 6MWD at 6 months after implantation.

Background The use of temporary mechanical circulatory support (tMCS) during arrhythmia is increasing, although available evidence for this indication is limited, with significant gaps of knowledge regarding appropriate timing, management and configuration. This systematic review sought to analyze the use of tMCS in patients with life-threatening arrhythmia. Methods A systematic literature search identified 2529 references published until September 2019. Adult and pediatric patients diagnosed with all kind of life-threatening arrhythmia were included. tMCS was primarily compared to conventional non-tMCS therapies. Primary outcome measure was in-hospital or 30-day mortality. Results 19 non-randomized studies were selected, including 2465 adult and 82 pediatric patients. Primary outcome in tMCS patients varied widely (4–62%) with differences based on the use of prophylactic tMCS (4–21%) or rescue tMCS (58–62%). A substantial mortality benefit was observed among high-risk patients, as identified with PAINESD risk score or suffering from electrical storm and treated with prophylactic tMCS. During ablation procedures, tMCS patients showed higher rates of induced ventricular tachycardias (VTs), ablated VTs, VT termination and non-inducibility after ablation. Extracorporeal membrane oxygenation (ECMO) was applied in pediatric cases as hemodynamic protection for aggressive antiarrhythmic medical treatment with >80% survival. Conclusions Prophylactic tMCS is associated with improved survival as compared to rescue or no-tMCS in patients with life-threatening arrhythmia, and may be considered in patients with high PAINESD risk score or suffering from electrical storm. ECMO can be advised as rescue and support therapy in pediatric cases requiring aggressive antiarrhythmic medical treatment.

BACKGROUND Device exchange to a newer generation left ventricular assist device (LVAD) offers the opportunity to benefit from improved adverse events profiles. We present the three year results of a patient cohort undergoing VAD upgrades to a new generation device focusing on outcomes and adverse events. METHODS We present the first series of patients who underwent LVAD upgrade to HeartMate 3. All operations were performed less invasively. Follow-up time was three years after LVAD exchange. RESULTS Overall four HeartMate II and two HVAD patients underwent LVAD upgrade. In five cases severe infection of the VAD led to device exchange (83%, 5/6). Three year survival after LVAD exchange was 100% (6/6). In the follow-up examinations one patient showed a single syncope and several low flow alarms (1/6). The remaining five patients showed no technical malfunctions of the LVAD or hemodynamic adverse events (5/6). Four out of five patients whose devices had to be changed due to an infection suffered a local re-infection (4/5), which, however, did not require any further surgical intervention. Four patients were successfully transplanted and two patients were still on device support at three years after LVAD exchange. CONCLUSIONS Three-year outcomes and adverse events after LVAD exchange to HeartMate 3 show excellent results. The superior hemocompatibility in terms of pump thrombosis makes the HM3 a favored choice in case of LVAD exchange due previous pump thrombosis. However, in cases of exchange due to device infection the risk of reinfection remains high.

Aims: Sympathetic overactivity, which predicts poor outcome in patients with heart failure, normalizes following cardiac transplantation. We tested the hypothesis that haemodynamic improvement following left ventricular assist device (LVAD) implantation is also associated with reductions in centrally generated sympathetic activity. Methods and results: In eight patients with heart failure (two women, six men, age 44-66 years), we continuously recorded electrocardiogram, beat-to-beat finger blood pressure, respiration, and muscle sympathetic nerve activity (MSNA) before and after implantation of the continuous-flow LVAD devices HeartWare HVAD (n = 4) and HeartMate II (n = 2), and the non-continuous-flow device HeartMate 3 (n = 2). LVAD implantation increased cardiac output by 1.29 ± 0.88 L/min (P = 0.060) and mean arterial pressure by 16.2 ± 7.9 mmHg (P < 0.001), while reducing pulse pressure by 25.3 ± 9.8 mmHg (P < 0.001). LVAD implantation did not change MSNA burst frequency (-1.3 ± 7.5 bursts/min, P = 0.636), total activity (+0.62 ± 1.83 au, P = 0.369), or normalized activity (+0.63 ± 4.23, P = 0.685). MSNA burst incidence was decreased (-7.8 ± 9.3 bursts/100 heart beats, P = 0.049). However, cardiac ectopy altered MSNA bursting patterns that could be mistaken for sympatholysis. Conclusion: Implantation of current design LVAD does not consistently normalize sympathetic activity in patients with end-stage heart failure despite haemodynamic improvement.

Left ventricular assist devices (LVADs) are widely used in selected patients suffering from end-stage heart failure (HF). However, their large-scale use has been limited in the past by their adverse events rate. With the development of the third LVAD generation characterized by centrifugal pumps, the role and application of LVADs for treating HF patients has globally increased with improving results, better quality of life and survival. This led to a growing need for scientific evidence supporting the large-scale application of this therapy.

For the success of the treatment with a left ventricular assist device (LVAD), both adequate self-management by the patient and an optimum level of support from the implanting hospital are crucial. A smartphone application has recently been developed within the framework of a European research project for the close monitoring of LVAD patients in order to improve upon their current aftercare situation. Using this new tool, different relevant parameters (eg, weight, international normalized ratio [INR], medication, LVAD parameters, symptoms, and photos of the driveline exit) can be sent daily or as required to a corresponding clinical application at the hospital for evaluation. The objective of this study was to monitor the functionality, acceptance, and usability of this smartphone application in LVAD patients. Prospective single-center study: in total, 13 patients (60 ± 7 years, 92% male, 1027 ± 653 days after LVAD implantation) were requested to test the application for approx. 4 weeks. At the end of the study, all entered data were evaluated and the patients were questioned regarding the acceptance and the usability. During the study period of mean 34 ± 8 days, a total of 453 data records (mean 35 ± 7 per patient) arrived at the hospital. In addition, a total of 19 photos of the driveline exit site were also sent via smartphone. The clinical application registered a total of 160 conspicuities. These comprised 126 INR deviations (target range 2.3-2.8) and 34 symptoms (mainly nosebleeds). The smartphone application functioned reliably, was well received by the patients and was graded highly for acceptance and usability. The results show that smartphone applications can definitely be used to improve aftercare in LVAD therapy in selected patients. Long-term studies are now needed to investigate the extent to which complications can be prevented, healthcare costs reduced, and quality of life increased.

Background: Left ventricular assist devices (LVAD) are increasingly used in patients with end stage heart failure. The HeartAssist 5 and aVAD LVADs offer telemetric monitoring capabilities. Here we report our initial single centre experience with the largest telemonitoring cohort of LVAD patients. Methods: Eleven patients (9 males) received a telemonitoring-capable LVAD and were included in our telemonitoring cohort. Waveforms and alarm data were obtained from the telemonitoring system and hospital records were reviewed for clinical data. Results: Mean age at LVAD implantation was 59±5.1 years (mean ± standard deviation). Seven patients had non-ischemic cardiomyopathy and 4 patients had ischemic cardiomyopathy. Median LVEF at implant was 16% (IQR, 15–20%). The total follow-up time was 2,438 patient-days. A total of 6,216 alarm messages were generated in 11 patients. Most common were low flow alarms due to hypovolemia, followed by low flow alarms because of suspected pump thrombosis. One patient died during follow-up, one received a cardiac transplant and one had the LVAD explanted because of pump thrombosis. Pump thrombosis was suspected in 5 patients with 8 episodes of sudden flow decreases and laboratory signs of haemolysis. Conclusions: Real-time telemonitoring of LVAD pump flow, motor speed and power consumption is a promising tool in the follow-up of LVAD recipients. Trending pump flow over hours or days can assist in the early detection of complications, especially flow reductions due to hypovolemia and LVAD thrombosis. Further studies are warranted to delineate the impact of remote monitoring on patients’ prognosis.

Current therapies significantly improve survival and clinical endpoints in patients suffering from chronic heart failure with reduced ejection fraction (HFrEF), but most are not sufficient to reverse adverse remodeling and improve myocardial contractility. Herein, we report the first-in-man experience with a novel fully implantable device for cardiac electrical microcurrent (C-MIC) application. A 79-year-old man suffering from HFrEF (dilated cardiomyopathy, NYHA class III, left ventricular ejection fraction 30%) successfully underwent implantation of the C-MIC device through left anterolateral thoracotomy. At 30-day follow-up, no device-related complications were observed, demonstrating feasibility of C-MIC implantation in a patient suffering from HFrEF.

Background: Worse outcomes in women compared to men undergoing left ventricular assist device (LVAD) implantation remain an underestimated problem in heart failure (HF) patients. With device miniaturization, less-invasive LVAD implantation techniques have gained relevance, but their impact on outcomes in women is unknown. This study investigates sex-related differences in patients undergoing LVAD implantation through less-invasive procedures. Methods: This retrospective single-center cohort study included patients who underwent isolated LVAD implantation between 2011 and 2018 through less-invasive techniques. Propensity score matching (PSM) was utilized to balance preoperative heterogeneity. Primary endpoint was two-year survival, and secondary endpoints included long-term survival, surgical outcomes and postoperative adverse events. Results: Baseline analysis of 191 patients (females 18.3%) showed differences in terms of age [female (median, 52; IQR, 47–61); male (median, 58.5; IQR, 49–66); P=0.005], underlying diagnosis (P

The use of lateral thoracotomy (LT) for implanting left ventricular assist devices (LVADs) is worldwide increasing, although the available evidence for its positive effects compared with conventional sternotomy (CS) is limited. This systematic review and meta-analysis analyzes the outcomes of LT compared with CS in patients undergoing implantation of a centrifugal continuous-flow LVAD. Four databases and 1,053 publications were screened until December 2019. Articles including patients undergoing implantation of a centrifugal continuous-flow LVAD through LT were included. A meta-analysis to compare LT and CS was performed to summarize evidences from studies including both LT and CS patients extracted from the same population. Primary outcome measure was in-hospital or 30-day mortality. Eight studies reporting on 730 patients undergoing LVAD implantation through LT (n = 242) or CS (n = 488) were included in the meta-analysis. Left thoracotomy showed lower in-hospital/30-day mortality (odds ratio [OR]: 0.520, 95% confidence interval [CI]: 0.27-0.99, p = 0.050), shorter intensive care unit (ICU) stay (mean difference [MD]: 3.29, CI: 1.76-4.82, p < 0.001), lower incidence of severe right heart failure (OR: 0.41; CI: 0.19-0.87, p = 0.020) and postoperative right ventricular assist device (RVAD) implantation (OR: 0.27, CI: 0.10-0.76, p = 0.010), fewer perioperative transfusions (MD: 0.75, CI: 0.36-1.14, p < 0.001), and lower incidence of renal failure (OR: 0.45, CI: 0.20-1.01, p = 0.050) and device-related infections (OR: 0.45, CI: 0.20-1.01, p = 0.050), respectively. This meta-analysis demonstrates that implantation of a centrifugal continuous-flow LVAD system via LT benefits from higher short-term survival, less right heart failure, lower postoperative RVAD need, shorter ICU stay, less transfusions, lower risk of device-related infections and kidney failure. Prospective studies are needed for further proof.

Acute hemodynamic decompensation (AHD) during ventricular tachycardia (VT) ablation occurs in about 11% of cases. Prophylactic use of temporary mechanical circulatory support (pro-tMCS) has been applied to prevent AHD during VT ablation, but evidence supporting this practice is still lacking. This systematic review and meta-analysis assessed the procedural characteristics and outcomes of pro-tMCS for VT ablation. PubMed/Medline was screened until February 2020. Articles including adults receiving pro-tMCS for VT ablation were included, and a meta-analysis to compare proMCS and no-tMCS was performed. Primary outcome was in-hospital/30-day mortality. Five observational studies presenting 400 procedures (pro-tMCS: n = 187; no-tMCS: n = 213) were included. Baseline characteristics were comparable between groups. Impella and TandemHeart were used in 86.6% and 13.4% of cases, respectively. In the pro-tMCS group, more VTs were induced (mean difference: 0.52, confidence interval [CI]: 0.26-0.77, P < .0001), and patients remained in VT on average for 24.04 minutes longer (CI: 18.28-29.80, P < .00001). Procedural success was comparable between groups, as was VT recurrence. Pro-tMCS patients had an odds ratio of 0.55 (CI: 0.28-1.05, P = .07) for in-hospital/30-day mortality and 0.55 (CI: 0.32-0.94, P = .03) for mortality at follow-up. Sixty-four percent of no-tMCS patients received rescue tMCS. The most common tMCS-related complications were bleeding events. Pro-tMCS allowed for a prolonged time on VTs and the induction of more VTs. Although these advantages were not associated with differences in procedural success, VT recurrence, or in-hospital/30-day mortality in the overall population, pro-tMCS might improve long-term survival. Further prospective studies are urgently needed to confirm these results.

Iron deficiency is common in patients with pulmonary hypertension [1, 2]. The underlying pathomechanisms are complex and include impaired iron absorption, elevated hepcidin levels, augmented gastrointestinal loss and reduced availability from the reticuloendothelial system [1, 3, 4]. In patients with pulmonary hypertension, iron deficiency is associated with aggravated symptoms and an increased mortality risk [3, 5]., Oral ferric maltol was well tolerated and effective in patients with pulmonary hypertension and iron deficiency anaemia. Restoration of iron stores corrected anaemia and resulted in improved right ventricular function and exercise tolerance https://bit.ly/2zMwvxc

Background The Abiomed Impella 5.5 (Danvers, MA) is a newly developed axial flow transaortic cardiac support device mounted on a 9 Fr steering catheter with a 21 Fr pump cannula . Impella 5.5 is intended for longer use and was approved for 30 days in 2018. This study evaluated the first-in-man series at six high-volume mechanical circulatory support centers in Germany after CE approval. Methods The first 46 consecutive patients worldwide underwent implantation in six German centers between March 2018 and September 2019 for post-CE approval evaluation. The primary end-point was 30 days and 90 days all-cause mortality. Results The mean age of patients was 59.0 ± 11.5 years, and 43 (93.4%) were men. Half of the patients had acute on chronic heart failure. The main indication for Impella 5.5 implantation was ischemic cardiomyopathy and acute myocardial infarction (47.8%). The mean support time was 15.5 ± 24.2 days (range 0-164, median 10 days (IQR = 7-19)) with a total of 712 patient-days on support. The 30 days and 90 days survival rates were 73.9% (95% CI: 63.3–88.9%) and 71.7% (95% CI: 60.7-87.1%), respectively. Additionally, 16 patients (34.8%) were weaned from the device for native heart recovery, and 19 (41.3%) were bridged to a durable device. Fifteen patients (32.6%) were mobilized to a chair, and 15 (32.6%) were ambulatory. We only noted one stroke and found no other thromboembolic complications . No aortic valve damage was observed in the study cohort. Finally, seven patients (15.2 %) had pump thrombosis, and nine (19.6 %) underwent device exchange. Sixteen patients (34.8 %) suffered from bleeding requiring transfusions during the whole treatment course. In ten patients (21.7%), the inflow cannula dislocated into the aortic root . Conclusions The first version of the Impella 5.5 presents promising early outcomes for patients with acute heart failure and expands the spectrum of available devices. The adverse event profile is favorable for short-term devices. Dislocations have been addressed by design changes. With increasing experience with this device, our study suggests that the indications for use will expand to other cardiac shock etiologies and may improve myocardial recovery and survival in patients with cardiogenic shock.

INTRODUCTION In patients with a left ventricular assist device (LVAD), the subcutaneous implantable cardioverter-defibrillator (S-ICD) can be an alternative to transvenous ICD systems due to reduced risk of systemic infection, which could lead to extraction of the ICD as well as the LVAD. S-ICD eligibility is lower in patients with LVAD than in patients with end-stage heart failure without LVAD. Several reports have shown inappropriate S-ICD therapy in the coexistence of LVAD and S-ICD. The aim of the present study was to evaluate S-ICD eligibility in patients with LVAD using the established electrocardiogram (ECG)-based screening test as well as a novel device-based screening test to identify potentially inappropriate S-ICD sensing in this specific patient cohort. METHODS AND RESULTS The present study included 115 patients implanted with an LVAD. The standard ECG-based screening test and a novel device-based screening test were performed in all patients. Eighty patients (70%) were eligible for S-ICD therapy with the standard ECG-based screening test. Performance of the novel device-based screening test identified device-device interference in 14 of these 80 patients (12%). CONCLUSION Using a novel extended device-based S-ICD screening method, a small number of patients with LVAD deemed eligible for S-ICD with the standard ECG-based screening test exhibit device-device interference. Careful S-ICD screening should be performed in patients with LVAD, who are candidates for S-ICD therapy, to prevent inappropriate sensing or ICD therapy.

This study was performed to evaluate the incidence and outcome of patients with ventricular assist devices (VADs) undergoing abdominal surgery at our institution. A total of 604 adult patients who underwent VAD implantation between February 2004 and February 2018 were analyzed retrospectively with a median follow-up time of 66 (6-174) months. Thirty-nine patients (6.5%) underwent abdominal surgery. Elective surgical procedures were performed in 22 patients (56.4%), mainly for abdominal wall hernia repairs, partial colectomies, and cholecystectomies. Early after elective abdominal surgery no patient died, resulting in a median survival of 23 (1-78) months. Emergency surgery was performed in 17 patients (43.6%). The most common emergency indications were intestinal ischemia and/or perforation. Eight patients undergoing emergent surgery (44.4%) died within the first 30 days after primary abdominal operation, mainly due to sepsis and consecutive multiple organ failure, resulting in a dismal median survival of one month (0-52). Patients undergoing abdominal surgery had significantly lower rates of realized heart-transplantation (p = 0.031) and a significantly higher rate of VAD exchange, before or after abdominal surgery, due to thromboses or infections (p = 0.037). Nonetheless, overall survival after primary VAD implantation in these patients (median 38 months; 0-107) was not significantly impaired when compared to all other patients undergoing VAD implantation (median 30 months; 0-171). In summary, elective abdominal surgery can be performed safely when well planned by an experienced multidisciplinary team. Abdominal complications in VAD patients requiring emergent surgery, however, lead to a significant increase in short-term morbidity and a high 30-day mortality rate.

Coronavirus disease 2019 (COVID‐19) has been declared a pandemic touching thousands of patients all around the world. Patients supported with left ventricular assist devices (LVADs) are usually affected by long‐standing cardiovascular diseases and subjected to variations of the normal cardiovascular physiology, thus requiring an even closer monitoring during the COVID‐19 outbreak. Nevertheless, the COVID‐19 pandemic led to a drastic reduction of routine clinical activities and a consequent risk of looser connections between LVAD patients and their referring center. Potential deleterious effects of such a situation can be delayed recognition of LVAD‐related complications, misdiagnosis of COVID‐19 and impaired social and psychological well‐being for patents and families. As one of the largest LVAD programs worldwide, we designed a sustainable and enforceable telemonitoring algorithm which can be easily adapted to every LVAD center so to maintain optimal quality of care of LVAD patients during the COVID‐19 pandemic.

Accurate definition of the extent and severity of left-ventricular assist device (LVAD) infection may facilitate therapeutic decision making and targeted surgical intervention. Here, we explore the value of (18)F-FDG PET/CT for guidance of patient management. Methods: Fifty-seven LVAD-carrying patients received 85 whole-body (18)F-FDG PET/CT scans for the work-up of device infection. Clinical follow-up was obtained for up to 2 y. Results: PET/CT showed various patterns of infectious involvement of the 4 LVAD components: driveline entry point (77% of patients), subcutaneous driveline path (87%), pump pocket (49%), and outflow tract (58%). Driveline smears revealed Staphylococcus or Pseudomonas strains as the underlying pathogen in most cases (48 and 34%, respectively). At receiver-operating-characteristic analysis, an (18)F-FDG SUV of more than 2.5 was most accurate to identify smear-positive driveline infection. Infection of 3 or all 4 LVAD components showed a trend toward lower survival than did infection of 2 or fewer components (P = 0.089), whereas involvement of thoracic lymph nodes was significantly associated with an adverse outcome (P = 0.001 for nodal SUV above vs. below median). Finally, patients who underwent early surgical revision within 3 mo after PET/CT (n = 21) required significantly less inpatient hospital care during follow-up than did those receiving delayed surgical revision (n = 11; P < 0.05). Conclusion: Whole-body (18)F-FDG PET/CT identifies the extent of LVAD infection and predicts adverse outcome. Initial experience suggests that early image-guided surgical intervention may facilitate a less complicated subsequent course.

(1) Objective: Bacterial resistance to conventional antibiotic therapy is an increasingly significant worldwide challenge to human health. The objective is to evaluate whether bacteriophage therapy could complement or be a viable alternative to conventional antibiotic therapy in critical cases of bacterial infection related to cardiothoracic surgery. (2) Methods: Since September 2015, eight patients with multi-drug resistant or especially recalcitrant Staphylococcus aureus, Enterococcus faecium, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Escherichia coli infections were treated with bacteriophage preparations as a therapy of last resort according to Article 37 of the Declaration of Helsinki. Patients had infections associated with immunosuppression after organ transplantation or had infections of vascular grafts, implanted medical devices, and surgical wounds. Individualized phage preparations were administered locally, orally, or via inhalation for different durations depending on the case. All patients remained on conventional antibiotics during bacteriophage treatment. (3) Results: Patients ranged in age from 13 to 66 years old (average 48.5 ± 16.7) with seven males and one female. Eradication of target bacteria was reached in seven of eight patients. No severe adverse side effects were observed. (4) Conclusions: Phage therapy can effectively treat bacterial infections related to cardiothoracic surgery when conventional antibiotic therapy fails.

Background The Heartmate 3 (HM3) is a Conformitee Europeenne mark–approved left ventricular (LV) assist device (LVAD) with fully magnetically levitated rotor and features consisting of a wide range operational speeds, wide flow paths, and artificial pulse. We performed a hemodynamic-echocardiographic speed optimization evaluation in HM3-implanted patients to achieve optimal LV- and right ventricular (RV) shape. Methods and Results Sixteen HM3 patients underwent pump speed ramp tests with right heart catheterization. Three-dimensional echocardiographic (3DE) LV and RV datasets (Philips) were acquired, and volumetric (Tomtec) and shape (custom software) analyses were performed (LV: sphericity, conicity; RV: septal and free-wall curvatures). Data were recorded at up to 13 speed settings. Speed changes were in 100-rpm steps, starting at 4600 rpm and ramping up to 6200 rpm. 3DE was feasible in 50% of the patients. Mean original speed was 5306 ± 148 rpm. LV end-diastolic (ED) diameter (−0.15 ± 0.09 cm/100 rpm) and volumes (ED: 269 ± 109 mL to 175 ± 90 mL; end-systolic [ES]: 234 ± 111 mL to 146 ± 81 mL) progressively decreased as the shape became less spherical and more conical; RV volumes initially remained stable, but at higher speeds increased (ED: from 148 ± 64 mL to 181 ± 92 mL; ES: 113 ± 63 mL to 130 ± 69 mL). On average, the RV septum became less convex (bulging toward the LV) at the highest speeds. Conclusions LV and RV shape changes were noted in HM3-supported patients. Although a LV volumetric decrease and shape improvement was consistently noted, RV volumes grew in response to increase in speed above a certain point. A next concern would be whether understanding of morphologic and function changes in LV and RV during LVAD speed change assessed with the use of 3DE helps to optimize LVAD speed settings and improve clinical outcomes.

The HeartMate 3 left ventricular assist device (Abbott, Chicago, IL) is designed to provide circulatory support with enhanced hemocompatibility for patients with advanced heart failure. The purpose of this study was to compare the surgical outcomes between patients treated during the European Conformity Mark (CE Mark [CEM]) clinical trial and those treated in the postmarket era.The prospective, observational, multinational ELEVATE (Evaluating the HeartMate 3 with Full MagLev Technology in a Post-Market Approval Setting) registry includes patients receiving the HeartMate 3 following CEM approval. Outcomes of patients in the ELEVATE registry are compared with patients in the CEM trial.Compared with the CEM trial (N = 50), the ELEVATE registry group (N = 463) was more severely ill, with more patients classified as INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profile 1 to 2 (32% versus 10%; p0.001). The CEM trial group was younger and underwent fewer concomitant valve procedures. After adjustment for differences in baseline characteristics, the 30-day survival was comparable between the ELEVATE registry and CEM trial groups (95% versus 98%; p = 0.46). Length of intensive care unit stay was similar between the ELEVATE registry (7 days) and CEM trial (6 days) groups. Most adverse event rates were comparable between the 2 groups. ELEVATE registry patients had a lower rate of cardiac arrhythmias (13% versus 28%; p = 0.009). With increasing experience, the implant technique has evolved to include more versatile approaches such as less invasive and off-pump implantation.The 30-day outcomes for ELEVATE registry patients are comparable despite being sicker than CEM trial patients. Adverse event rates remain low, with no cases of pump thrombosis within the first 30 days. Implant techniques have evolved to include more versatile approaches.

Background The increasing prevalence of heart failure has led to the expanded use of left ventricle assist devices (VADs) for end-stage heart failure patients worldwide. Technological improvements witnessed the development of miniaturized VADs and their implantation through less traumatic "non-full sternotomy approaches" using a lateral thoracotomy (LT). Although adoption of the LT approach is steadily growing, there remains a lack of consensus regarding patient selection, details of the surgical technique, and perioperative management. Furthermore, the current literature does not offer prospective randomized studies or evidence-based guidelines for LT-VAD implantation. Methods A worldwide group of LT-VAD experts was convened to openly discuss these key topics. After a PubMed search and review with all authors, a consensus was reached and an expert consensus paper on LT-VAD implantation was developed. Results This document aims to guide clinicians in the selection of patients suitable for LT approaches and preoperative optimization. Details of operative techniques are described, with an overview of hemisternotomy and bilateral thoracotomy approaches. A review of the best surgical practices for placement of the pump, inflow cannula and outflow graft provides advice on the best surgical strategies to avoid device malpositioning while optimizing VAD function. Experts´ opinions on cardiopulmonary bypass, postoperative management, and approaches for pump exchange and explant are presented. This paper also emphasizes the critical need for multidisciplinary teams and specified training. Conclusions This expert consensus paper provides a compact guide to LT for VAD implantation, from patient selection through intraoperative tips and postoperative management.

644 Objectives: In analogy to tumor volume, inflammatory volume (IV) can be obtained by threshold analysis of F-18-FDG-PET/CT in patients with LVAD infection, in order to describe the extent of infection. We sought to determine its practical value. Methods: 50 LVAD-carrying patients with advanced infection underwent whole-body F-18-FDG-PET/CT. IV was defined as volume of elevated FDG uptake in cm3, for the total device, for outer components (OC, subcutaneous parts and driveline entry) and internal device components (DC, pump pocket and outflow tract). Follow-up was obtained for 4 years after PET/CT, and deaths were recorded. Results: Systemic levels of c-reactive protein (CRP) correlated significantly with DC IV (r=0.3122, p=0.027), but not with OC IV (r=-0.1761, p=0.2212). During 4-year-follow-up 31 patients were reported to be deceased. CRP (mg/l) at the time of PET was significantly higher in patients who died (30.5±7.744 vs 10.87±3.658 for survivors; p=0.005). DC IV was not different (35.69±25.39 vs 26.33±20.23 for survivors; p=0.2116). Kaplan-Meier survival analysis revealed a significant difference between patients above and below the CRP median (p=0.022). Of note, if patients were subdivided into groups based on CRP and DC IV (CRP over/under 10.3 mg/l and levels of IV over/under 27.12 cm3), the subgroup with high CRP and high DC IV had significantly lowest survival (p

Background: Limited progress has been made in the management of cardiogenic shock (CS). Morbidity and mortality of refractory CS remain high. The effects of mechanical circulatory support (MCS) are promising, although many aspects are elusive. We evaluated efficacy and safety of early combined MCS (Impella microaxial pump + venoarterial extracorporeal membrane oxygenation [VA-ECMO]) in refractory CS and aimed to determine factors for decision-making in combined MCS. Methods and Results: We analyzed 69 consecutive patients with refractory CS from our registry requiring combined MCS. In 12 cases, therapy was actively withdrawn according to patient’s will. Patients were severely sick (Survival After Venoarterial ECMO score mean±SD, –8.9±4.4) predicting 30% in-hospital survival; ventilation 94%, dialysis 56%. Impella pumps and VA-ECMO were combined early (duration of combined MCS: median 94 hours; interquartile range, 49–150 hours). Early MCS escalation stabilized patients rapidly, reducing number and doses of catecholamines ( P P P =0.007) and lactate levels after 12 hours of MCS (hazard ratio, 1.28 [95% CI, 1.09–1.51]; P =0.002) independently predicted survival. Additional right ventricular failure predisposed to futility (hazard ratio, 8.48 [95% CI, 1.85–38.91]; P =0.006). Conclusions: The early and consequent combination of MCS by Impella microaxial pumps and VA-ECMO enables stabilization and may rescue high-risk patients with refractory CS at low overall risk. Independent predictors of survival may guide prognostication, decision-making, and allocation of medical resources.

Background: The paucity of available hearts for transplantation means that more patients remain on durable left ventricular support for longer periods of time. The Registry to Evaluate the HeartWare Left Ventricular Assist System was an investigator-initiated multicenter, prospective, single-arm database established to collect post-Conformité Européene mark clinical information on patients receiving the HeartWare ventricular assist device system as a bridge to transplantation. This registry represents the longest multicenter follow-up of primary left ventricular assist device outcomes. Methods: Data were collected on 254 commercial implants performed between February 2009 and March 2012 from 9 centers in Europe (7) and Australia (2). Patients were followed to device explant, heart transplantation, or death. The outcomes of patients through July/August 2018 were analyzed. Summary statistics were used to describe patient demographics, adverse events, length of support, and outcomes for this extended-term cohort. Results: A total of 122 patients were on support for >2 years, and 34 patients were on support for >5 years. Twenty nine patients are still alive on support (support ranging from 1213 to 3396 days), and 23 of those are on their original HeartWare ventricular assist device system. Kaplan–Meier survival through 7 years was 51%. Through 6 years, freedom from any stroke was 82%, while freedom from severely disabling stroke was 89%. Conclusions: Low rates of heart transplant now require longer periods of left ventricular assist device support in patients. This analysis demonstrates that long-term support using a HeartWare ventricular assist device system offers survival of 51% through 7 years.

Significant right ventricular failure accompanying left ventricular failure was treated by implantation of the fully magnetically levitated centrifugal HeartMate 3 ventricular assist device as biventricular (BiVAD) support in 14 patients at 6 medical centers worldwide. The clinical details of this first multicenter experience are presented. Nine of these patients (64%) were alive as of January 1, 2018. Eight of the 9 have continued on BiVAD support for 95 to 636 (mean 266) days: 7 at home, and 1 successfully transplanted after 98 days of support.

In modern times, advanced heart failure is a serious issue. Due to a shortage of donor hearts, the implantation of “Left Ventricular Assist Device” (LVAD) as destination therapy has become a common alternative. The LVAD is a mechanical continuous flow pump. However, there are several LVAD complications e.g. a pump thrombosis as a formation of a blood clot inside the LVAD pump. It can result in pump stoppage and lead to death. In order to ensure the success of thrombolytic therapy, it is important to detect a thrombosis early. Since an increase in LVAD power consumption is one indication for a pump thrombosis, this paper shows three algorithms analyzing the LVAD power. These algorithms test absolute and relative threshold and also consider the circadian fluctuation in LVAD power during the day. For the evaluation, a set of 352 LVAD log files including 7 thromboses was used. Compared to the “High Power Alarm”, which is a predefined thrombosis alarm of the LVAD controller, these algorithms detect all tested LVAD thrombosis up to 140 h earlier. Nevertheless, the algorithms still cause false alarms ( To reach an earlier and more precise LVAD thrombosis detection, continuous LVAD monitoring is required. Because the LVAD does not provide an interface, an Electrocardiography (ECG) based approach is tested as an alternative monitoring to acquire LVAD data. The LVAD produces an electromagnetical field, whose signal is visible in the ECG. It is utilized to calculate the LVAD speed of 9 LVAD patients using the Fast Fourier Transform. An accuracy of 99.8% was achieved. As external events also influence the LVAD measurements, changes in body posture on the LVAD is tested. The results show that the amplitude, measured during supine position, is significantly different to the amplitude measured during sitting and standing.

AIM This study aimed to assess safety and outcomes of patients, 2 years after implantation with the HeartMate 3 Left Ventricular Assist System. METHODS AND RESULTS This study included 50 adults with New York Heart Association (NYHA) class IIIB or IV symptoms or American College of Cardiology/American Heart Association stage D heart failure with an ejection fraction ≤25% and a cardiac index ≤2.2 L/min/m2 without inotropes, or inotrope-dependent with optimal medical management, or listed for heart transplant. The median duration of left ventricular assist device support was 694 days (range: 19-833 days). At baseline, cardiac index was 1.8 ±0.5 L/min/m2 , 58% of patients were receiving inotropes, and 92% were INTERMACS profiles 2-4. At 2 years, Kaplan-Meier survival was 74 ±6%, 5 (10%) patients were transplanted, and 32 patients (64%) remain with support. Adverse event rates include bleeding requiring surgery (16%), gastrointestinal bleeding (20%), driveline infection (24%), ischaemic stroke (16%), haemorrhagic stroke (8%), right heart failure (14%), and outflow graft thrombosis (2%). Notably, no haemolysis, pump thrombosis, or pump malfunction events occurred. At 2 years, 47% of patients remained in NYHA class I and 41% in NYHA class II (P

Introduction: Pump thrombosis of left ventricular assist devices remains a devastating complication with high morbidity and mortality. Despite the improvements made, the matter affects many patients and the treatment options are limited to thrombolysis and surgical replacement. An alternative approach using the aspiration Indigo catheter was tested. Methods: An Indigo thrombectomy catheter was used within an in vitro model to assess the direct aspiration of prefabricated clots from three different positions within the HeartWare HVAD (inlet, outlet, and housing). The experiments were conducted with a straight and an angled catheter. The aspiration pressure was constant. The flow, power consumption, and pressure head of the left ventricular assist devices were measured at pre-defined measuring points. Results: The device was more effective (success rate 71%) at inlet and outlet of the left ventricular assist device. In addition, the duration of aspiration and the aspiration volume were shorter in comparison to the aspiration in the housing (inlet M = 19.75 s, outlet M = 60.50 s, and housing M = 38.75 s). Moreover, the aspiration volume was associated with the aspiration duration and the weight of thrombi but not with their volume. Noteworthy, the angled catheter showed an improved performance compared to the straight one (67%–33%). The recorded parameters showed no major changes during the use of the catheter. After application of the Indigo catheter, flow and pressure head of the pump could be restored. Conclusions: The aspiration system showed promising results under specific conditions for the treatment of pump thrombosis in an in vitro model. However, further examination, including in vivo experiments, will justify its effectiveness.

Literature on driving capacities of ventricular assist device patients is rare and driving restrictions differ from center to center. Currently, no guidelines exist on whether and when left ventricular assist device (LVAD) patients are allowed to begin driving cars after device implantation. In this study, we assess the driving abilities of patients after LVAD implantation. Three hundred and ninety LVAD patients have been surveyed in a worldwide, multicenter study. The single survey followed a multi-method design, including online, phone, and face-to-face interviews. Out of 390 patients, 72% are still driving and 28% did not continue driving after LVAD implantation. Reasons for discontinuation were capability (24%), insecurity (17%), and disapproval by family members (9%) or doctors (5%). Ninety percent of the patients describe their ability to drive as perfect or adequate. Sixty-nine percent state that they are not restricted in their general driving capacity. Forty-nine percent report not to be restricted in agility to drive by the device equipment. The majority of patients have not been involved in car accidents or major complications (94%). Eight accidents were reported (3%). Out of those, all were minor collisions. No patient reported the occurrence of a fatal accident or casualties. LVAD alarms did occur in six incidents (2%) with the majority being low battery alarms. The results of this study suggest that driving with a left ventricular assist device is safe for stable patients and driving can be resumed 3 months after LVAD implantation after careful patient assessment.

Chronic end-stage heart failure (CHF) is a major healthcare problem with rapidly growing incidences in Europe and the United States (1). With decreasing cardiac transplant rates worldwide, alternative treatment methods become increasingly important.

Background: Device thrombosis is one of the main complications in left ventricular assist devices (LVAD) therapy and remains a challenging issue. Data on device thrombosis management, especially on the application of direct thrombin inhibitors such as argatroban, is limited and a consensus on thrombosis management has not yet been established. Methods: In this study we analysed retrospective clinical data obtained from 26 patients on VAD therapy who received argatroban for suspected VAD thrombosis, between April, 2012 and February, 2017. Results: Thirteen patients (50%) showed resolution of thrombus after argatroban therapy. Eight of 26 patients (30.8%) were free of thrombotic events 90 days after discharge. Argatroban therapy was unsuccessful in 13 patients of the study cohort, leading to subsequent VAD-exchange. Six of 13 patients with first VAD-exchange had no thrombotic events 90 days after discharge. Six patients (23.1%) suffered from bleeding, especially gastrointestinal bleeding. No hemorrhagic strokes were observed. Three patients (11.5%) did not survive the follow-up period. Conclusions: Argatroban appears to be an alternative to other pharmacological treatment options in VAD thrombosis. Efficacy and safety characteristics are acceptable, but further investigation on larger populations is necessary.

In this article, we present the case of a 72-year-old male patient suffering from a severe form of singular isolated end-stage right heart failure based on arrhythmogenic right ventricular cardiomyopathy (ARVC), who was admitted to our clinic for acute cardiac decompensation.

Pediatric heart transplantation (pHTx) represents only a small proportion of cardiac transplants. Due to these low numbers, clinical data relating to induction therapy in this special population are far less extensive than for adults. Induction is used more widely in pHTx than in adults, mainly because of early steroid withdrawal or complete steroid avoidance. Antithymocyte globulin (ATG) is the most frequent choice for induction in pHTx, and rabbit antithymocyte globulin (rATG, Thymoglobulin®) (Sanofi Genzyme) is the most widely-used ATG preparation. In the absence of large, prospective, blinded trials, we aimed to review the current literature and databases for evidence regarding the use, complications, and dosages of rATG. Analyses from registry databases suggest that, overall, ATG preparations are associated with improved graft survival compared to interleukin-2 receptor antagonists. Advantages for the use of rATG have been shown in low-risk patients given tacrolimus and mycophenolate mofetil in a steroid-free regimen, in sensitized patients with pre-formed alloantibodies and/or a positive donor-specific crossmatch, and in ABO-incompatible pHTx. Registry and clinical data have indicated no increased risk of infection or post-transplant lymphoproliferative disorder in children given rATG after pHTx. A total rATG dose in the range 3.5-7.5 mg/kg is advisable.

Myocardial recovery in left ventricular assist device patients is a rare opportunity to explant the assist device. Despite myocardial recovery, these patients remain high-risk candidates. Short, effective procedures are the key to successful left ventricular assist device explantation. Conventional methods such as ventriculoplasty are extensive and challenging procedures. Thus, an explantation tool was developed in order to simplify HeartMate 3 (Abbott Cooperation, Abbott Park, Ill, USA) explantation. A customized metal plug was designed to fit into the HeartMate 3-sewing ring. We now report the successful first-in-man use of this novel plug for HeartMate 3 explantation.