Interplay between driveline infection, vessel wall inflammation, cerebrovascular events and mortality in patients with left ventricular assist device.

In patients with left ventricular assist device (LVAD), infections and thrombotic events represent severe complications. We investigated device-specific local and systemic inflammation and its impact on cerebrovascular events (CVE) and mortality. In 118 LVAD patients referred for 18F-FDG-PET/CT, metabolic activity of LVAD components, thoracic aortic wall, lymphoid and hematopoietic organs, was quantified and correlated with clinical characteristics, laboratory findings, and outcome. Driveline infection was detected in 92/118 (78%) patients by 18F-FDG-PET/CT. Activity at the driveline entry site was associated with increased signals in aortic wall (r = 0.32, p < 0.001), spleen (r = 0.20, p = 0.03) and bone marrow (r = 0.20, p = 0.03), indicating systemic interactions. Multivariable analysis revealed independent associations of aortic wall activity with activity of spleen (ß = 0.43, 95% CI 0.18-0.68, p < 0.001) and driveline entry site (ß = 0.04, 95% CI 0.01-0.06, p = 0.001). Twenty-two (19%) patients suffered CVE after PET/CT. In a binary logistic regression analysis metabolic activity at the driveline entry site missed the level of significance as an influencing factor for CVE after adjusting for anticoagulation (OR = 1.16, 95% CI 1-1.33, p = 0.05). Metabolic activity of the subcutaneous driveline (OR = 1.13, 95% CI 1.02-1.24, p = 0.016) emerged as independent risk factor for mortality. Molecular imaging revealed systemic inflammatory interplay between thoracic aorta, hematopoietic organs, and infected device components in LVAD patients, the latter predicting CVE and mortality.

Use of left atrial appendage as an autologous tissue source for epicardial micrograft transplantation during LVAD implantation.

We report here the first clinical use of the left atrial appendage (LAA) for epicardial micrograft transplantation during left ventricular assist device (LVAD) implantation. Previously, a sample from the right atrial appendage (RAA) has been available for processing and administering micrograft therapy in cardiac surgery. Both LAA and RAA are rich sources of various types of myocardial cells and are capable of providing both paracrine and cellular support to the failing myocardium. The surgical approach of LAA micrografting facilitates epicardial micrograft therapy dose escalation and treatment of larger myocardial areas than done previously. Moreover, as collection of treated vs. untreated tissues from the recipient heart is possible following LVAD implantation at the time of heart transplantation, the evaluation of the therapy's mechanism of action can be further deciphered at cellular and molecular levels. This LAA modification of the epicardial micrografting technique has the overall potential to facilitate the adoption of cardiac cell therapy during heart surgery.

Three-month outcomes after the implantation of two HeartMate 3 devices in total artificial heart configuration.

BACKGROUND: Total artificial heart (TAH) implantation is a rarely performed procedure. Contrarily, left ventricular assist device (VAD) implantation is rather common in many centers. As transplantation is quantitatively limited cardiac replacement with artificial hearts is a viable alternative in the treatment of severe biventricular heart failure. An alternative to TAH is the implantation of two VADs in a TAH configuration. We hereby present the first multi-center study on 3-months outcomes of patients treated by cardiectomy and placement of two HeartMate 3s in a TAH configuration. METHODS: We retrospectively investigated a cohort of 15 patients that underwent HM3-TAH-implantation at three international institutions. Follow-up was 3 months after implantation. Baseline, intra- and postoperative parameters as well as survival data and adverse events were collected. RESULTS: A total of 1089 days on HM3-TAH were observed. Thirty-day survival after HM3-TAH implantation was 53% (8/15) and three month survival was 40% (6/15). The longest duration on device was 274 days. Causes of death were multi-organ failure, sepsis, and neurological adverse events. No technical complications were documented. Two patients remained on the device. Four patients (26%) were successfully bridged to transplantation. CONCLUSIONS: The implantation of two HeartMate 3s in a TAH configuration is a last resort and off-label concept in cases of extreme biventricular heart failure. In a diligently selected patient cohort, HM3-TAH implantation is a feasible method to increase the chance of survival in a severely ill patient cohort and successfully bridge patients to heart transplantation that would otherwise have died.

Novel Plug Device for HeartMate 3 Explantation: First Multicenter Experience.

Patients undergoing explantation of left ventricular assist devices (LVADs) after improvement of myocardial function remain a minority. Nevertheless, considering the growing population of LVAD patients, increasing demand for new explantation strategies is expected. Herein, we present a retrospective review of seven patients undergoing HeartMate3 explantation with the use of a custom-made apical ring plug in four medical centers. The primary outcome was status at intensive care unit discharge. Secondary outcomes included perioperative complications and transfusions. Six out of seven patients were males. The median age at explantation and time on LVAD support was 35 years (range:13-73) and 10 months (range:9-24), respectively. No technical difficulties were experienced during plug implantation via a conventional sternotomy or through a left lateral thoracotomy, either with or without cardiopulmonary bypass. Perioperative transfusions ranged from 0 to 3 units/patient. No re-operations for bleeding, hemorrhagic, embolic, or plug-related infective events were observed. Heparin was started 6 hours after surgery as a bridge to oral anticoagulation (international normalized ratio: 2-2.5). All patients were discharged alive from intensive care unit. This novel plug device for HeartMate3 explantation was successfully and safely implanted in this first patient series. Notwithstanding, its use should still be considered off-label and larger studies are required to investigate its long-term results.

Three-year follow-up after less-invasive left ventricular assist device exchange to HeartMate 3™.

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™ (Abbott Laboratories; Abbott Park, IL, USA). All operations were performed less invasively. Follow-up time was three years after LVAD exchange. RESULTS: Overall four HeartMate II™ (Abbott Laboratories; Abbott Park, IL, USA) 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 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™ (Abbott Laboratories). 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 re-infection remains high.

Sex differences in outcomes following less-invasive left ventricular assist device implantation.

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.

Five-year outcomes of patients supported with HeartMate 3: a single-centre experience.

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.

Advanced Preconditioning: Impella 5.5 Support for Decompensated Heart Failure Before Left Ventricular Assist Device Surgery.

Left ventricular assist devices (LVAD) are increasingly used in patients with advanced heart failure, and available devices and surgical techniques have strongly evolved over time. Adequate recompensation of patients before surgery is important for optimal surgical outcomes. However, patients with terminal heart failure frequently suffer from cardiorenal syndrome, which complicates recompensation by medical means. Here, we report on the use of an Impella 5.5 microaxial pump for supporting a patient with severely decompensated heart failure before LVAD implantation, which resulted in hemodynamic stabilization and effective recompensation prior to surgery.

Abdominal Surgery in Patients with Ventricular Assist Devices: a Single-Center Report.

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.

Minimally invasive left ventricular assist device implantation: optimizing device design for this approach.

Introduction: The global heart failure (HF) burden is expected to increase due to aging populations, increasing number of end-stage HF patients and adverse lifestyle changes. Mechanical circulatory support (MCS) devices such as left ventricular assist devices (LVADs) have become a promising treatment option for short-term and long-term circulatory support of end-stage HF patients.Areas covered: Recent developments in MCS technology have been focused on miniaturization leading to the development of minimally invasive surgical procedures for LVAD implantation. This helps overcome possible postoperative complications such as major incisions and poor outcomes due to infections, right heart failure, and bleeding. This article discusses clinical and technological developments in the field of minimally invasive procedures for LVAD implantation.Expert opinion: Most patients might benefit from minimally invasive LVAD implantation performed through a limited left lateral thoracotomy associated with an upper hemisternotomy or a right anterior thoracotomy. The thoracotomy approach can also be considered in case of pump exchange or pump explant. The success of these techniques is mainly based on the optimization of LVAD pump design, inflow cannula insertion, and outflow graft as well as driveline exit sites. The future direction of the LVAD field is likely to include less-invasive approaches and smartificial technologies.

First-in-man explantation of a HeartMate 3 left ventricular assist device via customized plug.

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.

Minimally invasive surgery improves outcome of left ventricular assist device surgery in cardiogenic shock.

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.

The influence of less invasive ventricular assist device implantation on renal function.

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).

One-year outcomes with the HeartMate 3 left ventricular assist device.

BACKGROUND: The HeartMate 3 (HM3; Abbott Laboratories, Lake Forest, Ill) left ventricular assist device (LVAD) received its Conformité Européenne mark for Europe in October 2015 and is currently under investigation of the Food and Drug Administration to gain approval in the United States. Within this study, we present the first real-world experiences, 1-year outcomes, and adverse events of a single-center cohort treated with the HM3. METHODS: We prospectively studied midterm results of 27 consecutive patients receiving the HM3 at a single institution. After HM 3 implantation, survival, causes of death, and complications were recorded for all patients. Follow up was 100% complete. RESULTS: Twenty-seven patients were enrolled into the study. Within 1 year after HM3 implantation, 3 patients underwent heart transplantation and 3 patients died. Thirty-day survival was 88.9%, 6-month 85.2%, and 1-year survival 85.2%. No pump thrombosis and no strokes were observed within the study group. One incident of gastrointestinal bleeding was observed (3.7%). Right heart failure was diagnosed in 1 patient after HM3 implantation (3.7%). No technical complications of the pump were documented. No pump exchanges were necessary. The main complication was LVAD-related infection (22.2%). CONCLUSIONS: The novel LVAD HM3 has already shown excellent Conformité Européenne mark trial results. Within this cohort, 1-year survival after HM3 implantation was 85%. The HM3 showed excellent midterm results with 0% stroke and 0% pump thrombosis rates 1 year after implantation.

Less Invasive Surgical Approaches for Left Ventricular Assist Device Implantation.

For several years, the standard implantation strategy of ventricular assist devices has involved a full sternotomy approach. However, less invasive implantation techniques are now becoming increasingly popular as they are associated with reduction of trauma, blood loss, and arrhythmogenic complications, as well as a decreased duration of intensive care unit and in-hospital stay. Thus, due to miniaturization and increasing technical improvement of ventricular assist devices, less invasive strategies for implantation, explantation, exchange, and concomitant cardiac procedures are on the rise. In this review article, we report on the state of the art of less invasive techniques for implantation, explantation, exchange, and combined cardiac procedures of ventricular assist devices.

Five-year results of patients supported by HeartMate II: outcomes and adverse events.

OBJECTIVES: Improved outcomes over the past decade have increased confidence of physicians and patients in extended duration of left ventricular assist device (LVAD) support. This single-centre cohort study reports 5-year outcomes with the HeartMate II (HMII) LVAD. METHODS: We describe a cohort of 89 patients who received a HMII LVAD between February 2004 and December 2010. The causes of death and adverse events were assessed by examination of medical records. A total of 202.74 patient-years were analysed. RESULTS: After 5 years, of the 89 patients, 15 patients remained on device therapy, 39 patients died, 28 patients underwent heart transplantation and 7 patients underwent explantation of the HMII for recovery. One year after the HMII implantation, there was a survival of 71% in the study cohort. In the following years, the survival rate was 65% in the 2nd year, 63% in the 3rd year, 56% in the 4th year and 54% after 5 years of LVAD support. Ten LVAD exchanges were performed in 8 (11%) patients. Currently (March 2017), 12 patients still remain on their original device. The longest ongoing patient on the HMII has been supported for over 11 years (4097 days). The most common adverse events were bleeding (68%; 1.5837 events per patient-year) and LVAD infection [49%; 1.0666 events per patient-year]. Seven cases of pump thrombosis were described (8%; 0.1131 events per patient-year). CONCLUSIONS: This is the first single-cohort study to describe a 5-year survival of HMII patients on extended duration of support. A 5-year survival of 54% was observed in this single-centre cohort.

Left Ventricular Assist Device Therapy for Destination Therapy: Is Less Invasive Surgery a Safe Alternative?

INTRODUCTION AND OBJECTIVES: The number of older patients with congestive heart failure has dramatically increased. Because of stagnating cardiac transplantation, there is a need for an alternative therapy, which would solve the problem of insufficient donor organ supply. Left ventricular assist devices (LVADs) have recently become more commonly used as destination therapy (DT). Assuming that older patients show a higher risk-profile for LVAD surgery, it is expected that the increasing use of less invasive surgery (LIS) LVAD implantation will improve postoperative outcomes. Thus, this study aimed to assess the outcomes of LIS-LVAD implantation in DT patients. METHODS: We performed a prospective analysis of 2-year outcomes in 46 consecutive end-stage heart failure patients older than 60 years, who underwent LVAD implantation (HVAD, HeartWare) for DT in our institution between 2011 and 2013. The patients were divided into 2 groups according to the surgical implantation technique: LIS (n = 20) vs conventional (n = 26). RESULTS: There was no statistically significant difference in 2-year survival rates between the 2 groups, but the LIS group showed a tendency to improved patient outcome in 85.0% vs 69.2% (P = .302). Moreover, the incidence of postoperative bleeding was minor in LIS patients (0% in the LIS group vs 26.9% in the conventional surgery group, P < .05), who also showed lower rates of postoperative extended inotropic support (15.0% in the LIS group vs 46.2% in the conventional surgery group, P < .05). CONCLUSIONS: Our data indicate that DT patients with LIS-LVAD implantation showed a lower incidence of postoperative bleeding, a reduced need for inotropic support, and a tendency to lower mortality compared with patients treated with the conventional surgical technique.

First results of HeartWare left ventricular assist device implantation with tunnelling of the outflow graft through the transverse sinus.

OBJECTIVES: The number of left ventricular assist device (LVAD) implants for the treatment of advanced heart failure is increasing tremendously. The main therapeutic goal of this operation is to provide a bridge to transplant for patients awaiting a donor heart. In 2011, we developed a novel, minimally invasive surgical technique for LVAD implantation. To avoid possible outflow graft injuries during redo sternotomies as well as to provide a more physiological outflow towards the aortic arch, a further modification of this approach was made with outflow graft tunnelling through the transverse sinus. METHODS: More than 500 LVADs were implanted at Hannover Medical School between 2008 and 2015. From September 2012 to December 2015, we used this novel technique in 17 consecutive bridge-to-transplant patients and analysed their clinical outcomes retrospectively. Baseline characteristics were obtained for all patients, and outcome data were collected from a review of electronic medical records. Subsequently, we compared the results of a data analysis of a group of 86 patients with a minimally invasive left thoracotomy LVAD implantation with the results from patients in a control group receiving a conventional outflow graft placement between May 2009 and January 2015. RESULTS: Our data demonstrate that the outcomes and adverse events of the operated group were comparable to those of the control group. Three patients of the study group died within the first year (3 of 17, 18%); survival to 3 years was 84%. The adverse events were similar in both groups. The study group had 3 ischaemic strokes (18%) and 1 LVAD thrombosis (6%). Five patients had LVAD thrombosis (5 of 86, 6%) and 6 in the control group had ischaemic strokes (6 of 86, 7%). The average in-hospital stay was 35.4 days for the study group and 27.4 days for the control group. Three patients from the study group and 5 from the control group had cardiac transplants. The average time until cannulation and start of extracorporeal circulation was 56 min in the study group and 96 min in the control group. Re-thoracotomy was necessary in 2 patients from the control group, whereas none was necessary in the study group. CONCLUSIONS: LVAD implantation with outflow graft tunnelling through the transverse sinus is an innovative technique to prevent outflow graft damage in case of cardiac resternotomy. The results of this study show that there are no significant differences in pump speed or flow, adverse events or patient outcomes compared with the standard implant techniques. The theoretical benefits of this novel technique are the reduced risk in redo cases and the physiological direction of blood flow. Consequently, this procedure might be particularly suitable for younger patients who received an LVAD as a bridge-to-transplant option.

First Implantation of a Novel Left Ventricular Assist Device: The ReliantHeart aVAD.

aVAD (ReliantHeart Inc, Houston, TX) is a new, compact, axial flow left ventricular assist device with novel features including real flow measurement, remote device monitoring, and a miniaturized pump housing. The aVAD received Conformité Européenne marking in August 2016. The use of this device was performed in a 61-year-old woman with severe heart failure. Following uneventful surgery, the patient recovered and was successfully discharged from the hospital.