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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.

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.

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.

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.

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

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.

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.

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: 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.

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.

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.

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.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).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).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.

Background Heart transplantation (HTx) and implantable left ventricular assist systems (LVAS) improve outcomes in advanced heart failure but may be underutilized. We hypothesized that screening can identify appropriate candidates. Methods and results The ScrEEning for advanced Heart Failure treatment (SEE-HF) study was a multicentre prospective study screening patients with existing cardiac resynchronization therapy (CRT) and/or implantable cardioverter-defibrillator (ICD) for ejection fraction ≤40% and New York Heart Association (NYHA) class III-IV, and subsequently for guideline-based HTx and LVAS indication. Of 1722 (mean age 64 ± 14 years, 26% women) patients screened at eight centres in seven European countries, 121 (7.0%) were eligible and 99 (5.7%; mean age 61 ± 10 years, 19% women) patients were enrolled for detailed assessment. Twenty-six of the 99 enrolled patients (26%) were eligible for either HTx or LVAD (18 eligible for HTx; 7 eligible for LVAD; and 1 eligible for both). Eleven patients were listed for HTx and three received an LVAS. Eligible patients were 61 ± 8 years and 19% women, whereas those actually receiving intervention were 56 ± 8 years and 8% women. Conclusions Among patients with CRT and/or ICD, a minority have NYHA class III-IV heart failure and ejection fraction ≤40%. Among these, however, more than one-quarter have an unrecognized need for HTx or LVAS. When patients are offered intervention based on screening, many decline. Discrepancies exist between clinical and patient equipoise. Clinical Trial Registration ClinicalTrials.gov Unique Identifier: NCT00894387.

Objectives Our goal was to present our 15-year experience (2001-2015) with the frozen elephant trunk (FET) technique. Methods A total of 251 patients (82 with aortic aneurysms, 96 with acute aortic dissection type A, 4 with acute type B dissections, 52 with chronic aortic dissection type A, 17 with chronic type B dissection and 67 redo cases) underwent FET implantation with either the custom-made Chavan-Haverich (n = 66), the Jotec E-vita (n = 31) or the Vascutek Thoraflex hybrid (n = 154) prosthesis. The cases were assigned to an early period (2001-2011) and a contemporary period (2012-present). Results Mean cardiopulmonary bypass time, aortic cross-clamp time, circulatory arrest time and selective antegrade cerebral perfusion time were 241 ± 72, 125 ± 59, 56 ± 30 and 81 ± 34 min, respectively. Incidence of rethoracotomy for bleeding, stroke, spinal cord injury, prolonged ventilatory support (>96 h) and long-term dialysis were 18, 14, 2, 24 and 2%, respectively. The in-hospital mortality rate was 11% (in acute aortic dissection type A, 12%). Of the 2 patients with graft infections, 1 died and the other had a protracted hospital stay. There were 49 second-stage procedures in the downstream aorta: either open surgical [n = 25 (thoraco-abdominal, n = 15; descending, n = 6; infrarenal, n = 4)] or transfemoral endovascular (n = 23). Elective thoracic endovascular aneurysm repair R implantation was successful in all 23 cases. Conclusions FET results are comparable with those of the published results of the conventional elephant trunk technique. FET is an ideal landing zone for subsequent transfemoral endovascular completion. Patients with graft infections may have dismal results.

Objectives The aortic valve-sparing David procedure has been applied to the elective treatment of patients with aortic aneurysms with excellent results. The use of this technique in patients with acute aortic dissection type A (AADA) is still a matter of debate. We present our long-term experience with 109 patients with AADA who had the valve-sparing David I procedure. Methods Between July 1993 and October 2015, 109 patients with AADA had the valve-sparing David I procedure at our centre. We conducted a retrospective review with follow-up. Results The mean age was 54 ± 12 years; 78 (72%) patients were men. Marfan syndrome was present in 6 (5%) patients and bicuspid aortic valve in 3 (3%). Only 4 (4%) patients received the isolated David procedure; 50 (46%) underwent additional proximal, 13 (12%) subtotal and 42 (39%) total aortic arch replacement. The in-hospital mortality rate was 11% ( n = 12). Intraoperative/discharge echocardiography showed aortic insufficiency ≤ I° in 93 of 97 patients (96%). Mean follow-up time was 8.3 ± 5.7 years. The survival rate after discharge at 1, 5 and 10 years was 94%, 90% and 78%, respectively. Thirteen percent ( n = 13) of patients underwent valve-related reoperation. Freedom from valve-related reoperation at 1, 5 and 10 years was 96%, 88% and 85%, respectively. Compared to patients who underwent the David I procedure for any reason other than AADA, there were no significant differences in long-term survival rates ( P = 0.29) and freedom from a valve-related reoperation ( P = 0.39). Conclusions The valve-sparing David I procedure has acceptable long-term results even in emergent operations for AADA and is not inferior when performed in elective settings.

Background The novel HeartMate 3 (HM3) left ventricular assist device (LVAD) received its CE mark in October 2015. It is a new compact LVAD featuring fully magnetically levitated pump, artificial pulse, large pump gaps, and a modular driveline. Here, we present outcomes and adverse events of a single-center cohort 6 months after HM3 implantation. Methods We retrospectively studied a patient cohort of 27 patients who were supported with the HM3 at a single institution. We excluded patients with biventricular assist devices and other types of assist devices as well as LVAD exchange and re-operative procedures. Results Twenty-seven patients were enrolled into the study. Within 1 year after HM3 implantation, 1 patient received a heart transplant and 3 patients died. Thirty-day survival was 88.9% and 6 months 85.2%. No pump thrombosis and no strokes were observed within 6 months. 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. Conclusions The novel LVAD HM3 has already shown good CE mark trial results. Within this first report after the CE mark trial, the 6-month survival after HM3 implantation was 85.2%. The HM3 showed excellent midterm results with 0% stroke and 0% pump thrombosis rates 6 months after implantation.

Introduction Indications and surgical techniques for pulmonary metastasectomy (PME) are controversially discussed issues. Laser-assisted surgery (LAS) is a recent innovation that has been advocated especially in patients with multiple pulmonary metastases (PM). However, there are hardly any studies comparing surgical outcomes after laser-assisted and conventional resection. The aim of the current study was to evaluate the value of LAS in a larger study population. Materials & methods A retrospective analysis was completed on 178 consecutive patients undergoing 236 PMEs at a single center between 2010 and 2015. The main endpoint was survival. Statistical analysis was performed using the Kaplan–Meier method and survival rates were compared with the log rank test. Follow-up was done with special attention to the development of recurrent PM. Local relapse was defined as a recurrent metastasis in direct relation to the previously resected area according to CT scan comparisons. Results LAS was performed on 256 metastases in 99 patients, non-laser-assisted surgery (NLAS) on 127 metastases in 79 patients. 5-year-survival rates were 69.3% in all patients, 65.7% after LAS and 73.6% after NLAS. There was no statistically significant survival difference after LAS or NLAS (p = 0.41). The rate of local relapse was 0.8% after LAS vs 3.1% after NLAS (p = 0.073). Conclusion Despite a larger number of negative predictors for survival in LAS patients, overall survival (OS) was similar in the compared groups. There was also a trend for a lower risk of local relapses after LAS. Therefore, LAS should be considered a promising method for PME.

Adequate physical and functional performance is an important prerequisite for renewed participation and integration in self-determined private and (where appropriate) professional lives following left ventricular assist device (LVAD) implantation. During cardiac rehabilitation (CR), individually adapted exercise programs aim to increase exercise capacity and functional performance. A retrospective analysis of cardiopulmonary exercise capacity and functional performance in LVAD patients at discharge from a cardiac rehabilitation program was conducted. The results from 68 LVAD patients (59 males, 9 females; 55.9 ± 11.7 years; 47 HVAD, 2 MVAD, 15 HeartMate II, 4 HeartMate 3, and 4 different implanting centers) were included in the analysis. Exercise capacity was assessed using a cardiopulmonary exercise test on a bicycle ergometer (ramp protocol; 10 W/min). The 6-min walk test was used to determine functional performance. At discharge from CR (53 ± 17 days after implantation), the mean peak work load achieved was 62.2 ± 19.3 W (38% of predicted values) or 0.79 ± 0.25 W/kg body weight. The mean cardiopulmonary exercise capacity (relative peak oxygen uptake) was 10.6 ± 5.3 mL/kg/min (37% of predicted values). The 6-min walk distance improved significantly during CR (325 ± 106 to 405 ± 77 m; P

Background Current recommendations of antithrombotic therapy for HeartMate II (HMII) patients include the use of both an anticoagulant and an antiplatelet agent. Because bleeding is still the most frequent adverse event, the TRACE (STudy of Reduced Anti-Coagulation/Anti-platelet Therapy in Patients with the HeartMatE II) study was initiated to evaluate the incidence of adverse events in HMII patients on reduced antithrombotic (RT) therapy. Methods HMII patients (n = 101) from nine centers were enrolled in the European arm of TRACE and were managed on a single anticoagulant (vitamin K antagonist) with no antiplatelet agents. An analysis of bleeding and thrombotic adverse events from all 101 patients with 2-year follow-up after initiation of RT therapy is reported here. Results Median age was 56 years (range, 18 to 72 years), 93% were men, 70% had an Interagency Registry for Mechanically Assisted Circulatory Support profile 1 to 3, and 82% received the HMII as a bridge to transplantation. Ninety-two percent were placed on RT therapy as a center standard of care or due to physician preference and 6% as a response to bleeding. Median HMII support duration on RT therapy was 25 months (range, 1 to 93 months). Median international normalized ratio was 2.31 [quartile 1 to quartile 3: 2.07 to 2.60]. At 2 years, freedom from bleeding, ischemic stroke, hemorrhagic stroke, and pump thrombosis after initiation of RT therapy was 81% ± 6%, 96% ± 2%, 94% ± 3%, and 94% ± 3%, respectively. Conclusions The 2-year analysis of the observational European TRACE study suggests that managing HMII patients with a vitamin K antagonist with a target international normalized ratio of 2.3 without antiplatelet therapy may help to reduce the incidence of major bleeding without increasing the risk of thromboembolic events, including ischemic stroke and pump thrombosis.

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.

Aims The ELEVATE Registry was designed to study long-term outcomes with the Heartmate 3 (HM3), a fully magnetically levitated centrifugal ventricular assist device, in a real-world population following CE-mark approval. Methods and results A total of 540 patients, implanted in Europe and the Middle East were followed in ELEVATE. The registry included 463 patients receiving the HM3 as primary implant (Primary Implant Cohort), 19 patients underwent a pump upgrade from another device (Pump Exchange Cohort) and 58 patients who had experienced an outcome before having the possibility to sign the Informed Consent, for which only outcome data were collected (Anonymized Cohort). Data collection included demographics, survival, adverse events, EQ-5D Visual Analog Score quality of life (EQ-5D VAS QOL) questionnaire, and 6-min walk distance (6MWD). Mean age was 55.6 ± 11.7 years (89% male, 48% ischaemic cardiomyopathy). Seventy per cent of patients were in INTERMACS Profile 1–3 and 12.7% were on temporary mechanical circulatory support. Primary Implant Cohort survival was 83% after 2 years. In the Powered by Editorial Manager® and ProduXion Manager® from Aries Systems Corporation Primary Implant Cohort, strokes were observed in 10.2%, gastrointestinal bleedings in 9.7%, pump thrombosis in 1.5%, and outflow graft twists in 3.5%. Heartmate 3 implantation resulted in a significant and sustained improvement of functional capacity and QOL. Conclusion In a real-world population, cohort implanted with the HM3 left ventricular assist device we demonstrate good long-term survival, sustained improvement of functional capacity, and low rates of adverse events (including pump thrombosis). ClinicalTrials.gov Identifier NCT02497950

BACKGROUND: Nearly 1000 permanent ventricular assist devices (VADs) are implanted in patients with severe congestive heart failure in Germany each year. VADs are miniaturized centrifugal pumps that generate continuous blood flow; they are powered and controlled through a cable that passes through the skin. Paracorporeal systems are only rarely implanted, usually in children. METHODS: In this selective review of the literature, including guidelines and registry data, we discuss the indications, therapeutic effects, and complications of permanently implantable cardiac support systems. RESULTS: The optimal time for VAD implantation cannot be precisely defined. A comparative assessment of the various available systems is not possible, as no randomized trials have been performed on this topic. Registry data indicate that 69% to 81% of patients survive one year after VAD implantation, which is significantly better than the natural course of (conservatively treated) severe congestive heart failure. The distance patients are able to walk is 129 to 220 m longer at six months, depending on the system implanted. Scores on the EQ-5D health status questionnaire are 28 to 37 points better at six months. The potential severe complications include infection, right-heart failure, hemorrhage, pump thrombosis, stroke, and death. CONCLUSION: A VAD system can be implanted as an alternative to cardiac transplantation or as a bridging treatment until the patient can be listed for transplantation and receive the transplant. Because of the organ shortage in Germany, only a minority of VAD patients ever receive a transplant.

Introduction: Heart failure (HF) is one of the rising problems in the contemporary society with growing incidences of end-stage HF. While heart transplantation (HT) is the gold standard treatment for end-stage HF, its availability is limited by the lack of heart donors. As a consequence, left ventricular assist devices (LVADs) are becoming key therapies as bridge to transplant (BTT) strategy to improve survival and outcomes.Areas covered: A significant advancement for wider applications of LVADs as BTT was facilitated by the introduction of miniaturized pumps such as the HVAD (HeartWare®, Medtronic, MN, USA), allowing intrapericardial implants and less-invasive approaches. In this review article, we describe the technical features of the HVAD and its outcomes in terms of efficacy and safety when implanted as BTT strategy. Moreover, we discuss the postoperative results of HT in HVAD recipients and its application in the pediatric population.Expert opinion: It has been demonstrated that the HVAD positively influences the survival of end-stage HF patients awaiting HT, with an acceptable rate of adverse events. Due to its reduced size, it is particularly suitable for LVAD implantations through lateral thoracotomy and in patients with small thoracic dimensions.

Because of the decreasing availability of donor hearts and the simultaneous increase in patients with terminal heart failure, the implantation of a left ventricular assist device has become the only reasonable alternative to heart transplantation. The systems themselves have undergone considerable development and corresponding miniaturization. The so-called driveline, the cable that exits the body via the abdominal wall and connects the pump to the control unit and power supply, continues to represent a weak point in the system. As a foreign body, the driveline provides an ideal entry port for germs. All along the driveline, infections can develop with subsequent sepsis, affecting the entire pump. Deep infections spreading via the driveline are one of the greatest problems surrounding left ventricular assist device therapy. Exchanging the pump is frequently the only option, leading to significant morbidity. Transposition of the greater omentum in cardiothoracic surgery has proven beneficial in the management of complex, infected wounds and their cleaning. This paper describes the surgical procedure of omentoplasty to clean up driveline infections.

Myocardial stem cell therapy in heart failure is strongly dependent on successful cellular transfer, engraftment, and survival. Moreover, massive cell loss directly after intramyocardial injection is commonly observed, generating the need for efficient longitudinal monitoring of transplanted cells in order to develop more efficient transplantation techniques. Therefore, the aim of the present study was to assess viability and cardiac retention of induced pluripotent stem cells after intramyocardial delivery using in vivo bioluminescence analysis (BLI) and magnetic resonance imaging (MRI). Murine induced pluripotent stem cells (iPSCs) were transfected for luciferase reporter gene expression and labeled intracellularly with supraparamagnetic iron oxide particles. Consequently, 5 × 105 cells were transplanted intramyocardially following left anterior descending coronary artery ligation in mice. Cardiac iPSCs were detected using BLI and serial T2* sequences by MRI in a 14-day follow-up. Additionally, infarct extension and left ventricular (LV) function were assessed by MRI. Controls received the same surgical procedure without cell injection. MRI sequences showed a strong MRI signal of labeled iPSCs correlating with myocardial late enhancement, demonstrating engraftment in the infarcted area. Mean iPSC volumes were 4.2 ± 0.4 mm3 at Day 0; 3.1 ± 0.4 mm3 at Day 7; and 5.1 ± 0.8 mm3 after 2 weeks. Thoracic BLI radiance decreased directly after injection from 1.0 × 106 ± 4.2 × 104 (p/s/cm2 /sr) to 1.0 × 105 ± 4.9 × 103 (p/s/cm2 /sr) on Day 1. Afterward, BLI radiance increased to 1.1 × 106 ± 4.2 × 104 (p/s/cm2 /sr) 2 weeks after injection. Cardiac graft localization was confirmed by ex vivo BLI analysis and histology. Left ventricular ejection fraction was higher in the iPSC group (30.9 ± 0.9%) compared to infarct controls (24.0 ± 2.1%; P

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.

In June 2014 the worldwide first implantation of a new and promising Left Ventricular Assist System (LVAS) for end-stage heart failure therapy was performed by Dr. Schmitto and his team at Hannover Medical School, Hannover, Germany (1).

Summary of Objectives The HeartMate 3 (HM3) Long Term Follow Up Study (NCT03022461) is an extension of the original HM3 CE mark study where patients ongoing at 2-year follow-up were reconsented and followed up to 5 years with the aim to evaluate the long-term performance in the patients who continue to be implanted with the HM3 LVAS. Methods Of the 50 patients enrolled in the HM3 CE Mark Study, 5 (10%) patients were transplanted, 1 (2%) was explanted, 12 (24%) expired prior to 24 months, 4 (8%) expired after 24 months but prior to reconsent for the additional follow-ups, 3 (6%) denied their participation to the study extension while 25 (50%) consented for the extended follow-up. To date, of the 25 reconsented patients, 2 patients expired (8%) whereas 23 patients (92%) are still ongoing on support. Additional adverse events collected beyond 2 years included: major bleeding (3 events in 2 patients, 8%) of which 1 (4%) required surgery; major infection (16 events in 8 patients, 32%) of which 8 were driveline infection in 6 pts (32%) and 6 sepsis in 2 patients (8%); ischemic stroke (2 events in 2 pts, 8%), haemorrhagic stroke (1 event in 1 patient, 4%) and right heart failure in 1 patient (4%) which was resolved pharmacologically. No pump thrombosis, hemolysis or gastrointestinal bleeding were reported during the extended follow-up period. At the time of data cut-off, 4 patients (16%) were in NYHA Class I and 6 (24%) in NYHA Class II. Endpoints Preliminary five years results of the first clinical experience with HM3 LVAS implantation corroborate expected and well acceptable survival and support outstanding hemocompatibility of the device represented by complete absence of pump thrombosis, hemolysis or gastrointestinal bleeding. To the date, 5 years follow-up visits were completed in 10 patients and full longitudinal follow-up will be accomplished by January 2020.

Implantation of a left ventricular assist device (LVAD) leads to a diverse spectrum of changes on the twelve-lead surface electrocardiogram (ECG). We aimed to elucidate the changes of the surface ECG in patients after LVAD implantation potentially impacting ECG based screening tests of subcutaneous implantable cardioverter-defibrillators (S-ICD).Patients from 2005 until 2017 with a documented twelve-lead ECG before and after LVAD implantation were included. Baseline parameters were obtained through hospital records. The twelve-lead ECGs registered before and after LVAD implantation were analyzed.From 415 patients undergoing an LVAD implantation, complete datasets were available for 253 patients. 216 patients (85%) were male. Mean age at time of LVAD implantation was 54.7 ± 12.4 years. The underlying etiology was ischemic cardiomyopathy in 119 (47%), dilated cardiomyopathy in 112 (44%), myocarditis in 8 (3%) and other in 14 (6%). We observed a reduction in the amplitude of the R wave in lead I (p 0.0001), lead II (p 0.0001), lead III (p 0.004), lead aVL (p 0.001) and lead aVF (p 0.0001) as well as of the S wave in lead III (p 0.001) and lead aVR (p 0.0001) after LVAD implantation. We also noticed a reduction of the R:T ratio in lead I (p 0.0001) as well as in lead II (p = 0.100) and lead aVF (p = 0.292) although statistically non-significant.LVAD implantation leads to significant alterations of the surface ECG, especially the R:T ratio in leads I, II and aVF. These leads correlate with the vectors of the ECG based S-ICD screening test. Thus, these ECG changes may impact the continuous eligibility for subcutaneous ICD therapy in patients after LVAD implantation.

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.

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