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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<0.001), INTERMACS profile (P=0.009), history of previous cardiac surgery (P=0.049) and preoperative creatinine values [female (median, 110; IQR, 71-146); male (median, 126; IQR, 9-168); P=0.049]. Over a follow-up of 460.68 patient-years, Kaplan-Meyer analysis showed better survival in females (P=0.027) and a similar probability of cardiac transplantation (P=0.288). After PSM, females showed higher needs for intraoperative fresh frozen plasma (P=0.044) and platelets (P=0.001) but comparable postoperative outcomes. No sex-related differences were noticed regarding two-year outcomes, long-term survival and adverse events. LVAD-related infections remained the most common complication with males experiencing more pump infections than women (P=0.050)., Conclusions: Patients receiving less-invasive LVAD implantation do not show significant sex-related differences in short and long-term outcomes and survival. Prospective studies are needed to evaluate the role of less-invasive techniques in reducing sex-based disparities after LVAD implantation., Competing Interests: Conflicts of Interest: JDS and GD are consultants for Abbott and Medtronic. JSH is consultant for Abbott. LCN received consultant, proctoring and lecture honoraria from Abiomed and lecture honoraria from Abbott, Maquet and Orion, outside the submitted work. Other relationships unrelated to this work exist. RL is consultant for Medtronic and LivaNova, and Advisory Board Member of Eurosets: all honoraria are paid to the University for research support. The other authors have no conflicts of interest to declare., (2021 Annals of Cardiothoracic Surgery. All rights reserved.)

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., Competing Interests: Conflicts of Interest: B Lynch is an employee of Reliant Heart Inc., Houston, Texas. The other authors have no conflicts of interest to declare.

Background: Pump thrombosis is the most severe and acute complication of left ventricular assist device (LVAD) therapy and treatment remains challenging. Whilst lysis therapy is often not successful, the exchange of the occluded LVAD is currently the most applied therapeutic treatment for this event. With this study we examine the effects of minimal-invasive LVAD exchange on the rate re-thrombosis and outcomes as well as adverse events in the study group., Methods: Between February 2004 and December 2015 more than 600 LVADs were implanted at our institution. We retrospectively studied a patient cohort of 41 patients who underwent LVAD exchange because of pump thrombosis at a single institution. Outcomes, rates of re-thrombosis and adverse events were analyzed., Results: Between February 2004 and December 2015, 87 exchanges of LVADs were performed at a single center. In 41 cases pump thrombosis was the reason for LVAD exchange. A total of 28 patient years (10,276 days) were analyzed. Average ICU stay was 15.8±20.4 days and average in-hospital stay 38.1±37.3 days after LVAD exchange. After thirty days the survival rate was 80.5%, 75.6% after 6 months and 70.7% one year after LVAD exchange. Out of the study cohort, three patients have successfully undergone heart transplantation. Twelve patients suffered a stroke postoperatively (29%). Twelve patients needed postoperative dialysis (29%). No technical complications of the VAD were recorded in the study group. Two patients underwent successful LVAD explantation due to myocardial recovery. One year after LVAD exchange, 14 patients underwent re-exchange due to pump thrombosis (34%). Eight patients suffered from a LVAD related infection out of which two patients were treated by pump exchange. A total of 12 patients died during the complete one year follow up of this study (29%). Four patients died in the second, two in the third and one in the fourth year after LVAD exchange. The remaining 17 patients are still ongoing on the device. Conclusions: It is generally feasible to treat pump thrombosis via LVAD exchange. Yet, the exchange procedure is not without risk and the risk of re-thrombosis (34%), stroke (29%), postoperative dialysis (29%) and perioperative complications remains high., Competing Interests: Conflicts of Interest: JD Schmitto receives consultation fees from Thoratec Cooperation. JD Schmitto and G Dogan are consultants for HeartWare Cooperation. The other authors have no conflicts of interest to declare.

Left ventricular assist devices (LVADs) are emerging as the treatment of choice for advanced heart failure due to the dearth of healthy donor hearts for cardiac transplantation. The HeartMate 3 LVAD is a novel centrifugal pump which was developed to provide hemodynamic support in heart failure patients, either as a bridge to transplant (BTT), myocardial recovery, or as destination therapy (DT). Technological and clinical advancements have led to optimized hemocompatibility and development of less invasive surgical procedures for the implantation of this pump. The worldwide first implantation of the HeartMate 3 was performed by Prof. Schmitto and his team at Hannover Medical School, Germany in 2014, paving the way for subsequent surgical developments. This article summarizes the advanced technological and clinical aspects of the HeartMate 3 and outlines future technical developments for safe and effective treatment of advanced heart failure., Competing Interests: Conflicts of Interest: JD Schmitto receives consultation fees from Abbott. The other authors have no conflicts of interest to declare.

Growing worldwide incidences of end-stage heart failure and declining rates of cardiac transplants have given rise to the need for alternative treatment options, based on mechanical circulatory support (MCS) devices such as left ventricular assist devices (LVADs). Technologically advanced LVADs such as the HVAD ® (HeartWare ® , Medtronic) facilitate safe and efficient treatment of heart failure patients with reduced post-operative complications, which is attributed to their considerably miniaturized size. This also facilitates the development and implementation of novel, minimally-invasive surgical techniques. The HVAD is a centrifugal pump, manufactured by HeartWare Inc., (Framingham, MA, USA) and subsequently by Medtronic Inc., (Minnesota, MN, USA), and has been approved for clinical application after receiving the CE Mark approval in 2008 and the FDA approval in 2012. Current research efforts are focused on further miniaturization alongside optimization of electronic and software controllers as well as implementation of the transcutaneous energy transfer (TET) technology. Salient features of the HVAD pump technology, clinical applications and future optimization strategies have been discussed in this article., Competing Interests: Conflicts of Interest: JD Schmitto and G Dogan are consultants of Medtronic. The other authors have no conflicts of interest to declare.

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., Competing Interests: Conflicts of Interest: JD Schmitto and G Dogan are consultants of Medtronic Corporation. JD Schmitto receives consultation fees and financial grants from Abbott Laboratories. The other authors have no conflicts of interest to declare.

Background: Driveline infection (DLI) is one of the leading causes for unplanned re-admissions of patients undergoing therapy with left ventricular assist devices (LVAD). In previous studies our group was able to show that a double tunneling implantation technique could significantly reduce infection rates one year after implantation. We now report the results of the five-year-follow up of patients receiving the double tunneling technique., Methods: We retrospectively analyzed patients receiving LVAD therapy with the HeartWare ventricular assist device (HVAD) (Medtronic, Minnesota, MN, USA) LVAD. For 36 patients (group 1) the driveline was tunneled via a conventional technique. In the remaining 33 patients (group 2) the drivelines were implanted by means of a double tunneling technique. The double tunnel driveline technique involved placement of the driveline in the sheath of the rectus muscle in the umbilical direction and then subcutaneously to the left (alternatively right) upper quadrant. We retrospectively compared both groups. Primary outcome parameters were infection rate and mortality., Results: Five years after LVAD implantation the DLI rate of patients operated by a double tunneling technique was significantly lower than in the conventional technique group [61% (n=22) group 1 vs. 30% (n=10) group 2, P=0.004]. The 5-year mortality was lower in group 2 [42% (n=15) group 1 vs. 27% (n=9) group 2] but did not achieve statistical significance (P=0.10). The days of LVAD support between the two groups were comparable (1,275.56±885.89 group 1 vs. 1,321.94±711.37 group 2). The tunnel technique itself showed to be strongly associated with the occurrence of DLI. Other elevated variables are liver disease and dilated cardiomyopathy as primary disease., Conclusions: Double tunneling technique for driveline implantation leads to significantly lowered infection rates after 5 years of LVAD therapy and it is associated with a lower mortality., Competing Interests: Conflicts of Interest: JD Schmitto and G Dogan are consultants of Medtronic. The other authors have no conflicts of interest to declare.

Competing Interests: Conflicts of Interest: JD Schmitto and G Dogan are consultants of Medtronic. Other authors have no conflicts of interest to declare.

Background: Left ventricular assist device (LVAD) (HVAD, Medtronic, Minneapolis, MN, USA) implantation is already a widely accepted treatment option for end-stage heart failure (HF) but also still considered as a rescue therapy for patients suffering from cardiogenic shock. Standard LVAD implantation techniques are often associated with high mortality rates and can result in severe complications, like bleeding or right heart failure (RHF). The aim of our study was to assess the outcome of Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) 1 patients (so called "crash and burn" patients) undergoing a LVAD implantation by standard or less invasive surgery., Methods: We performed a retrospective evaluation of the 1-year outcome of 32 consecutive HF patients in cardiogenic shock, who underwent LVAD implantation in our institution. A total of 32 INTERMACS 1 patients were emergently operated. Fourteen patients (group A) were operated by using the "Hannover-VAD-technique", which is widely known to be less invasive (upper hemisternotomy and a left-sided anterolateral thoracotomy). In contrast, 18 patients (group B) were implanted with LVAD by using the standard technique (full sternotomy). The primary endpoint was survival after 1 year without device-related re-operations. Secondary endpoints included combined analyses of rates of RHF, respiratory failure and bleeding during the trial period., Results: Baseline characteristics were similar in both groups. Survival after 1 year was higher in group A (69.7% vs. 50.0%). Technique-related adverse events (AEs) were also lower in the minimally invasive group, including a lower RHF (35.7% vs. 61.1%) and of further postoperative bleeding requiring surgery (14.3% vs. 33.3%)., Conclusions: LVAD surgery in INTERMACS 1 patients is associated with remarkably good outcome considering the already very high mortality of those patients, and compared to previously reported surgical outcomes. Our study indicates that minimally invasive LVAD implantation in cardiogenic shock decreases mortality and the incidence of postoperative AEs., Competing Interests: Conflicts of Interest: JD Schmitto and G Dogan are consultants of Medtronic; LC Napp received lecture honoraria from Abiomed and Maquet. The other authors have no conflicts of interest to declare.

Background: End-stage heart failure is associated with severe after-effects such as heart valve insufficiency, cardiac arrhythmias or end-organ dysfunctions. Renal failure or 'cardiorenal syndrome' is a critical end-organ disorder associated with advanced heart failure, which occurs due to low-output failure. Drug therapy or surgical interventions involving left ventricular assist device (LVAD) implantation may impede the progress of heart insufficiency and its after-effects including renal failure. In this study, we investigated the impact of a minimally invasive ventricular assist device implantation through upper hemisternotomy combined with anterolateral thoracotomy on renal function, in patients with perioperative renal failure., Methods: We analyzed data obtained from 103 patients (80 males, 23 females; mean age 53.8±11.7) who underwent LVAD implantation at our clinic within a 15-year interval (2001-2016) and were dialyzed due to renal dysfunction. 90 patients were operated with the conventional LVAD implantation technique (standard approach surgery, SAS) and 13 underwent less invasive approach implantation (less invasive surgery, LIS)., Results: For all patients, data analysis showed significant increase of glomerular filtration rate (GFR) (44.2±56.48 mL/min; 95% CI: 33.81-55.28; P<0.001) along with a significant decrease in the levels of creatinine (-1.08±1.83 mg/dL; 95% CI: 0.75-1.46; P<0.001) and urea (-4.62±13.66 mmol/L; 95% CI: 1.95-7.29; P<0.001). There was a considerable difference in change of renal parameters in patients treated with LIS in comparison to patients who underwent SAS, which was however not statistically significant (GFR: P=0.494; creatinine: P=0.543; urea P=0.918)., Conclusions: LVAD implantation improves kidney function in patients with renal dysfunction. A considerable difference in the change of renal parameters was detected in patients with LIS as compared to SAS, which was not significant possibly due to the limited size of the patient cohort (n=13)., Competing Interests: Conflicts of Interest: JDS is a consultant for Thoratec Corporation as well as HeartWare Inc. The other authors have no conflicts of interest to declare.

Background: Pump thrombosis (PT) is still one of the major adverse events in patients supported with left ventricular assist devices. Nowadays, thrombus detection relies on clinical parameters like reoccurring heart failure symptoms, on changes in pump power consumption, and on laboratory parameters such as increased LDH and hemolysis. Once detected PT is most often persistent and refractory to medical therapy. We therefore designed a novel, non-invasive acoustic method for early pump thrombus detection in an in vitro artificial thrombus model., Methods: The study was performed in vitro using a mock circulation loop, artificial blood (water-glycerin) and artificial thrombus material (silicon) allowing for repeatable and defined testing. Tested ventricular assist device (VAD) type was HVAD (Medtronic). Three different thrombus locations were evaluated: on the tilted pad of the rotor, in the primary flow path, and in the secondary flow path beneath the rotor. After evaluating baseline parameters (no thrombus, n=20 for each pump), the influence of thrombi of seven different masses (no thrombus, 0.5-5.0 mg) on pump power consumption and acoustic emission of four HVAD devices was investigated via a microphone system (Sennheiser) and subsequent frequency spectrum analysis (n=12). The acoustic analysis algorithm included the number of frequency peaks recorded., Results: Measurements with thrombi on the tilted pad showed an increased number of frequency peaks with all thrombus sizes compared to baseline measurements without any thrombus (baseline: 32.7±7.4; 0.5 mg: 45.3±10.4 up to 5 mg: 80.4±5.5). Power consumption was relevantly elevated in 5mg thrombus measurement only (6.3±1.29 W compared to 4.9±0.14 W at baseline). Measurements with thrombi in the primary and secondary showed no relevant alteration in power consumption and frequency peak count., Conclusions: We present an acoustic method that detects pump thrombi located on the tilted pad of the HVAD rotor requiring ten times less mass compared to thrombi detected by power consumption alterations used in current detection algorithms. Assuming that pump thrombi are growing over several days, the presented method may detect PT much earlier thereby increasing efficacy of medical therapy and helping to avoid pump exchange., Competing Interests: Conflicts of Interest: JD Schmitto and G Dogan are consultants for Medtronic and Abbott. The other authors have no conflicts of interest to declare.

Background: Functional mitral valve regurgitation is a frequent consequence of left ventricular dysfunction in patients with severe heart failure and is associated with a poor prognosis. It is hypothesized that in this patient group the mitral valve repair, respectively replacement, improves hemodynamics and clinical symptoms. As operative interventions with the help of heart-lung-machine are high risk procedures in these cases, the transcatheter mitral repair with MitraClip ® (Abbott Vascular, IL, USA) has recently become frequently used. Most of these cases experience a progress in left ventricular dysfunction, which finally leads to in an implantation of a left ventricular assist device. In this report, we describe a series of six cases in which patients with end stage heart failure and consecutive functional mitral valve regurgitation were supported with a left ventricular assist device after MitraClip implantation. We aimed to investigate, whether the MitraClip implantation leads to an improvement of the hemodynamic prior left ventricular assist device (LVAD)-implantation., Methods: We retrospectively analyzed the data of 6 patients (5 males, 1 female) with severe heart failure, who underwent LVAD implantation after the MitraClip procedure. The mean age at MitraClip procedure was 64.6 years, mean age at time of LVAD implantation was 65.5 years. The parameters examined were cardiac index (CI), left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDD) and the pulmonary capillary wedge pressure (PCWP)., Results: All patients had functional mitral regurgitation (MR). Severity of MR was reduced successfully in all treated patients. All patients were discharged with MR I-II and NYHA functional class III or IV after MitraClip procedure. The mean CI was 2.93 before MitraClip procedure and 2.36 before LVAD-Implantation. Mean LVEDD was 71 mm before MitraClip, mean LVEDD was 70.6 mm before LVAD, and 63.2mm after LVAD implantation respectively. The mean PCWP was 21.5 mmHg before MitraClip and 19.8 mmHg before LVAD implantation respectively. The mean left ventricular ejection fraction (LVEF) was 19.2% before MitraClip, the mean LVEF was 17.6% before LVAD and 15% after LVAD implantation. Two of the LVAD implanted patients died due to post-operative complications. There were no complications after MitraClip procedure., Conclusions: Our presented patient cohort presented little hemodynamic improvement after the MitraClip procedure. There was no clinical benefit for the patients after MitraClip procedure, progressing left ventricular dysfunction could not be prevented and resulted in subsequent LVAD implantation., Competing Interests: Conflicts of Interest: JD Schmitto and G Dogan are consultants for Abbott and Medtronic. The other authors have no conflicts of interest to declare.

Although rare, recovery of cardiac function after mechanical support of the left ventricle is the most desirable therapeutic goal in the treatment of end-stage heart failure.Herein, we present a novel implantable device for explantation of the HeartMate 3™ left ventricular assist device (LVAD) in patients, following cardiac recovery, avoiding (re-) sternotomy.This article demonstrates the feasibility of applying this novel device, which fits into the sewing ring of the LVAD.This custom-made mechanical plug offers a promising alternative to standard device-explantation procedures., Competing Interests: Conflicts of Interest: Jan D. Schmitto and Guenes Dogan are consultants for Abbott. Other authors have no conflicts of interest to declare.