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Background The implantation of rapid-deployment aortic valves may interfere with the conduction system of the heart. This study evaluates the occurrence and predictive factors of conduction anomalies in patients undergoing surgical aortic valve replacement (SAVR) with a rapid-deployment balloon-expandable bioprosthesis in a single-center, real-world experience. Methods Between May 2010 and April 2019, 700 consecutive patients were included in a prospective, ongoing database with a longitudinal follow-up preoperatively, at discharge, and at 3 months, 1 year, 3 years, and 5 years postoperatively. Thirty-seven patients (5.3%) had a permanent pacemaker at baseline and were excluded from further analysis, leaving 663 patients for analysis. Assessment of conduction anomalies was performed by electrocardiography (ECG) monitoring and repeated 12-lead ECG during the hospital stay and at postoperative follow-ups. Results Preoperatively, 126 patients (19.0%) presented with different conduction disturbances. New permanent pacemaker implantation (PPI) occurred in 61 patients during the first 14 days (cumulative incidence, 9.4%). The indication for PPI was complete atrioventricular block in 47 cases (77%). Preoperative conduction anomalies, such as right bundle branch block, as well as operative characteristics (concomitant procedures) were found to be independent predictors for new PPI. One-year survival was 98% in patients with new early PPI and 96% in those without new early PPI (P = .60). Conclusions The PPI rate was in the range of previous reports for rapid-deployment prostheses. PPI did not have a significant influence on short- to intermediate-term survival. Case selection with exclusion of patients presenting with baseline conduction disturbances may decrease the rate of new PPIs after SAVR with rapid-deployment balloon-expandable bioprostheses.

Venoarterial-extracorporeal membrane oxygenation (VA-ECMO) is a life-saving method for patients with low-output failure after cardiac surgery. However, VA-ECMO therapy may increase left ventricular afterload due to retrograde blood flow in the aorta, which may lead to progression of pulmonary congestion. We examined the predictive value of pulmonary congestion in patients that need VA-ECMO support after cardiovascular surgery.We enrolled a total of 266 adult patients undergoing VA-ECMO support following cardiovascular surgery at a university-affiliated tertiary care centre into our single-center registry. Pulmonary edema was assessed on bedside chest X rays at day 0, 3, 5 after VA-ECMO implantation.Median age was 65 (57-72) years, 69% of patients were male and 30-day survival was 63%. At ICU-admission 20% of patients had mild, 54% had moderate and 26% showed severe pulmonary congestion. Pulmonary congestion at day 0 was not associated with outcome (adjusted HR 1.31; 95%-CI 0.89-1.93;P = 0.18), whereas pulmonary congestion at day 3 (adj. HR 2.81; 95%-CI 1.76-4.46;P0.001) and day 5 (adj. HR 3.01;95%-CI 1.84-4.93;P0.001) was significantly associated with survival. Linear regression revealed that out of left ventricular function, cardiac output, central venous saturation, maximum dobutamine and norepinephrine dose as well as fluid balance solely ECMO rotation was associated with the evolution of pulmonary congestion (P = 0.007).Pulmonary edema three and five days after ECMO implantation are associated with poor survival. Interestingly, a high VA-ECMO output was the most important determinant of worsening pulmonary congestion within the first five days.

Background Aortic valve replacement in patients with a small aortic root is a matter of concern in terms of prosthesis-patient mismatch. We evaluated the survival and hemodynamic performance after implantation of a small rapid-deployment aortic valve (EDWARDS INTUITY valve system sizes 19 and 21 mm). Methods Between May 2010 and November 2018, 659 consecutive patients with severe aortic stenosis who received a rapid-deployment valve were included in a prospective and ongoing database. A small aortic bioprosthesis (sizes 19 mm and 21 mm) was implanted in 217 (32.9%) patients (mean age 74.9 ± 7.9 years, 85.3% women). Preoperative characteristics, operative parameters, and postoperative outcomes were assessed. Results Mean gradients at discharge and 1 year were 14.8 ± 5.6 mm Hg and 13.6 ± 4.9 mm Hg, respectively. Mean effective orifice area and the indexed effective orifice area at discharge were 1.55 ± 0.36 cm2 and 0.87 ± 0.22 cm2/m2, respectively, and prosthesis-patient mismatch occurred in 77 (35.5%) patients (25.8% moderate and 9.7% severe). Perioperative mortality was 1.8% (n = 4 of 217) and overall survival at 1 year and 5 years was 91% and 79%, respectively. The presence of any prosthesis-patient mismatch degree did not have a significant influence on overall survival (hazard ratio, 0.95; 95% confidence interval, 0.75-1.19; P = .638). At the last follow-up, mean New York Heart Association functional class was 1.5 ± 0.7 vs 2.8 ± 0.6 at baseline (P Conclusions Surgical aortic valve replacement with rapid-deployment valves has shown improved results concerning hemodynamic performance, with decreased rates of prosthesis-patient mismatch. We observed excellent early-term and midterm survival and a significant improvement in functional class in this subgroup of patients with a small annulus.

The aim was to evaluate the association of molecular-level human leukocyte antigen (HLA) mismatching with post-transplant graft survival, rejection, and cardiac allograft vasculopathy (CAV). We retrospectively analyzed all primary cardiac transplant recipients between 01/1984-06/2016. 1167 patients fulfilled inclusion criteria and had HLA typing information available. In 312 donor-recipient pairs, typing at serological split antigen level was available. We used the Epitope MisMatch Algorithm to calculate the number of amino acid differences in antibody-verified HLA eplets (amino acid mismatch load (AAMM)) between donor and recipient. Patients with a higher HLA-DR AAMM load had inferior 1-year graft survival (hazard ratio [HR], 1.14; 95% confidence interval [CI], 1.01-1.28). The HLA-AB AAMM load showed no impact on graft survival. In the subgroup with available split-level information, we observed an inferior graft survival for a higher HLA-DR AAMM load 3 months after transplantation (HR, 1.22; 95% CI, 1.04-1.44) and a higher risk for rejection for an increasing HLA-AB (HR, 1.70; 95% CI, 1.29-2.24) and HLA-DR (HR, 1.32; 95% CI, 1.09-1.61) AAMM load. No impact on the development of CAV was found. Molecular-level HLA mismatch analysis could serve as a tool for risk stratification after heart transplantation and might take us one step further into precision medicine.

BACKGROUND: The Edwards Intuity Valve System is a bioprosthesis with a balloon-expandable stent frame which enables rapid-deployment (RD). We aimed to analyze our single-center long-term experience with a follow-up until 9 years after aortic valve replacement (AVR) with this bioprosthesis. METHODS: Between May 2010 and May 2019, 700 consecutive patients with severe aortic stenosis or combined aortic valve disease, implanted with a RD valve at our institution, were included in a prospective database. Median follow-up was 19 months and the total accumulated follow-up was 2,140 patient-years. Pre-operative characteristics, operative parameters, survival rates, valve-related adverse events and valve hemodynamics were assessed. RESULTS: Mean age was 74±8 years, 45% female. Concomitant procedures were performed in 339 (48.4%) patients. In case of isolated AVR (361/700), a minimally invasive surgical (MIS) approach was conducted in 283 patients (78.4%). Cardio-pulmonary bypass (CPB) and cross-clamp times for isolated AVR were 107.7±28.2 and 73.8±21.3 minutes for MIS approaches and 92.8±28.8 and 57.5±20.6 minutes for full sternotomy (P

Quadruple valve surgery represents a complex and rare surgical procedure, requiring a systematic and standardized approach. In this intervention, pulmonary valve replacement (PVR) in patients without pre-existing congenital heart disease represents a challenge and no large data have been reported yet. We hereby report a case of bioprosthetic PVR in an octogenarian within a quadruple valve procedure, illustrating our preferred technique of PVR with bioprosthetic implantation and right ventricular outflow tract reconstruction.

The era of intracorporal continuous flow pumps has initiated significant success of left ventricular assist device (LVAD) surgery. However, median sternotomy has been the only surgical approach for implantation over many years. During the last decade, less-invasive access ways gained popularity. Within this review, we describe our own clinical experience in minimally invasive ventricular assist device (VAD) surgery and summarize the current scientific literature on this topic.

Prolonged support times in bridge to transplant patients, as well as the growing number of destination patients lead to increased rates of LVAD pump exchanges for pump thrombosis, pump infections, and other device problems. We describe our surgical approach for pump exchanges in patients supported with the Heartware HVAD ventricular assist device. Pump exchanges are performed via a limited thoracotomy in the fourth, fifth, or sixth left intercostal space with cardiopulmonary bypass support. The apical sewing ring as well as the outflow graft are reused in order to limit the complexity of the procedure and minimize the need for extensive dissections. Given the significant reduction in surgical complexity and invasiveness, the described technique should be considered the standard approach for Heartware HVAD patients with device complications necessitating isolated pump exchanges.

Left ventricular assist device outflow graft stenosis is a rare but life-threatening complication of mechanical cirulatory support therapy. Current treatment modalities (pump exchange or systemic thrombolytic therapy) are associated with significant mortality and morbidity. Implantation of bare metal stents within the stenosed outflow graft is an alternative. Herein, we describe a series of three cases with successful stent placement. This seems to be safe and successful; however, correct and early diagnosis of outflow stenosis can be challenging. Information provided by the HeartWare ventricular assist device (HVAD) logfiles is extremely helpful for diagnosis.

Background Structural valve deterioration (SVD) with associated bioprosthetic valve dysfunction remains an unsolved problem, exposing patients to the risk of aortic valve re-intervention after surgical aortic valve replacement (SAVR). Several strategies have been proposed to improve prosthesis design for optimal performance. The leaflets of the Trifecta valve are mounted on the outside of the prosthetic stent to achieve a larger orifice area. Although favourable early clinical outcomes have been reported, long-term durability still needs to be assessed. Purpose The aim of the current study was to assess the mid-term overall mortality and re-intervention rate in patients who received a Trifecta valve with a follow-up >5 years. Methods Patients who underwent SAVR at our centre between 2011 and 2012 were identified in the internal, prospective database. All patients with implantation of a Trifecta valve in aortic position were included. Primary endpoints were freedom from overall mortality and from re-operation at latest follow-up (FU). Additionally, assessment of echocardiographic parameters at baseline and follow-up was performed. Results Seventy-six patients (age 77.3±9.5 years, BMI 28.6±5.8, 68% male) were included in the study. EuroScore II was 7.2% (± 7.7) while mean STS-Mortality score was 2.4±1.1%. Of all procedures, 53% were isolated aortic valve replacements, whereas concomitant procedures were performed in 47% of cases (37% CABG, 12% mitral surgery, 8% tricuspid surgery). Baseline echocardiographic assessment showed a mean pressure gradient (MPG) of 51±21 mmHG, a peak pressure gradient (PPG) of 78±36 mmHG and a peak velocity (Vmax) of 4.2±1.1 m/s. Thirty-day mortality was 7%. Freedom from overall mortality at 1 year and 5 years was 84% and 73%, respectively. Freedom from death and freedom from re-operation at latest FU (6.7±0.5 years) was 68% and 90%, respectively. In a composite endpoint analysis, freedom from death or re-intervention at latest follow up was 60%. A total of 7 patients underwent aortic valve re-interventions (re-replacements n=5, valve-in-valve n=2). Indications for re-interventions were SVD (n=5), NSVD (n=1, pannus ingrowth) and endocarditis (n=1). One case of re-stenosis occurred in a patient who was deemed not feasible for aortic valve re-intervention and died. Kaplan Meier analysis Conclusion(s) To our knowledge, this patient cohort presents with the lowest rate of freedom from re-operation (90%, 6.7±0.5 years) after SAVR with the Trifecta valve. A relatively high number of SVD and NSVD has been observed, which might be attributable to the specific leaflet mounting or the deformable valve frame of the first generation. Current results call for further investigation with prospective echocardiographic follow-up in this patient group. Acknowledgement/Funding None

New left ventricular assist devices (LVADs) offer both important advantages and potential hazards. VAD development requires better and expeditious ways to identify these advantages and hazards. We validated in an isolated working heart the hemodynamic performance of an intraventricular LVAD and investigated how its outflow cannula interacted with the aortic valve. Hearts from six pigs were explanted and connected to an isolated working heart setup. A miniaturized LVAD was implanted within the left ventricle (tMVAD, HeartWare Inc., Miami Lakes, FL, USA). In four experiments blood was used to investigate hemodynamics under various loading conditions. In two experiments crystalloid perfusate was used, allowing visualization of the outflow cannula within the aortic valve. In all hearts the transapical miniaturized ventricular assist device (tMVAD) implantation was successful. In the blood experiments hemodynamics similar to those observed clinically were achieved. Pump speeds ranged from 9 to 22 krpm with a maximum of 7.6 L/min against a pressure difference between ventricle and aorta of ∼50 mm Hg. With crystalloid perfusate, central positioning of the outflow cannula in the aortic root was observed during full and partial support. With decreasing aortic pressures the cannula tended to drift toward the aortic root wall. The tMVAD could unload the ventricle similarly to LVADs under conventional cannulation. Aortic pressure influenced central positioning of the outflow cannula in the aortic root. The isolated heart is a simple, accessible evaluation platform unaffected by complex reactions within a whole, living animal. This platform allowed detection and visualization of potential hazards.

Awake extracorporeal life support (ECLS) implantation is an attractive option for unstable patients for whom avoiding the risk of hemodynamic deterioration during intubation is important. In this video tutorial we show, step by step, a successful awake ECLS implantation, placing special emphasis on safeguards and potential pitfalls.

Structural valve deterioration represents the most important concern regarding the implantation of a biologic heart valve in young patients. Several strategies have been proposed to improve prosthesis design in order to optimize performance and durability. This report describes an early and specific mode of valve degeneration of prostheses with outward-mounted pericardial leaflets resulting from pannus overgrowth on the aortic side. This led to leaflet retraction in two consecutive cases 4 and 6 years after the first implantation of a Trifecta valve (St. Jude Medical, St. Paul, MN).

OBJECTIVES Although extracorporeal membrane oxygenation (ECMO) represents a rapidly evolving treatment option in patients with refractory heart or lung failure, survival remains poor and appropriate risk stratification challenging because established risk prediction models have not been validated for this specific population. METHODS This observational single-centre registry included a total of 240 patients treated with venoarterial ECMO therapy following cardiovascular surgery and analysed the discriminatory power of the European System of Cardiac Operative Risk Evaluation (EuroSCORE) additive, the EuroSCORE II, the Sequential Organ Failure Assessment (SOFA) score, the Simplified Acute Physiology Score (SAPS) II, the SAPS III, the Acute Physiology and Chronic Health Evaluation (APACHE) II, the Risk of renal failure, Injury to the kidney, Failure of kidney function, Loss of kidney function and End-stage renal failure (RIFLE) classification, the survival after venoarterial ECMO (SAVE) score, the prEdictioN of Cardiogenic shock OUtcome foR AMI patients salvaGed by VA-ECMO (ENCOURAGE) score and the Society of Thoracic Surgeons (STS) risk model for outcome prediction. RESULTS During a median follow-up time of 37 months (interquartile range 19–67), 65% of the patients died. Only the SAVE score and the SAPS II were significantly associated with the 30-day mortality rate with a hazard ratio (HR) of 1.06 [95% confidence interval (CI) 1.02–1.11; P = 0.002] for the SAVE score and an HR of 1.02 (95% CI 1.01–1.03; P = 0.004) for the SAPS II with a modest discriminatory power displayed by a C-index of 0.61 and 0.57, respectively. Seven out of 10 scoring systems revealed significant association with long-term mortality, with the SAVE score and the SAPS II remaining the strongest predictors of long-term mortality with an HR of 1.06 (95% CI 1.03–1.09; P CONCLUSIONS Risk assessment based on established risk models in patients with ECMO remains difficult. Only the SAPS II and the SAVE score were exclusively found to be suitable for short- and long-term outcome prediction in this specific vulnerable patient population.

We demonstrate the technical aspects of a novel adjustable mitral ring. This new ring was implanted in a female landrace pig, for training and educational purposes. It can be adjusted independently in the P1, P2 and P3 segments, if required, to treat recurrent mitral regurgitation, and this is a key difference to comparable devices. The first-in-man implantation is anticipated in the near future.

Purpose Previous studies have shown a correlation between improved renal function and ventricular assist device implantation, resulting in improved survival rates. This study aims to strengthen this correlation and establish long term findings by increasing the size of the study cohort as well as study period. Methods We retrospectively reviewed the data of 389 patients who received ventricular assist device implantation due to terminal heart failure at our center from 12/2003 to 03/2018. Median duration of LVAD support was 307 days (range 1 to 2849 days). Renal function was assessed using the Modification of Diet in Renal Disease study-derived Glomerular Filtration Rates (MDRD-GFR; mL x min(-1) x 1.73m(-2)). According to pre-implantation measured GFR rates patients were categorized in three groups: normal renal function (GFR>90, n= 52); moderately impaired renal function (GFR 30-90; n=295) and severely impaired renal function (GFR Results Mean GFR showed a significant increase of renal function in both the moderately impaired and severely impaired kidney function groups at week 1 post-implantation (moderately: 56.0 ± 15.6 to 81.6 ± 39.0; severely: 22.7 ± 5.0 to 43.5 ± 19.0; p Conclusion Ventricular assist device implantation improves the renal function in terminal heart failure patients with moderate to severe kidney dysfunction. Normal renal function is correlated with better outcomes post LVAD implantation.

We thank Heinrich-Nols and Kreuzer for their valuable and very detailed response regarding the indication of dabigatran, its dosing regimen, and relevant considerations regarding monitoring of anticoagulation. We had to shorten our initial article significantly and were not able to address all points regarding dabigatran dosing and management.1 The dose was chosen in 2010 according to the approved indication at that time, which was the primary prevention of …

BACKGROUND: Decision-making when offered a donor heart for transplantation is complex, and supportive data describing outcomes according to acceptance or non-acceptance choices are sparse. Our aim was to analyze donor heart acceptance decisions and associated outcomes at a single center, and after subsequent acceptance elsewhere.METHODS: This investigation was a retrospective analysis of data obtained from the University of Vienna Medical Center and Eurotransplant centers for the period 2001 to 2015RESULTS: Our center accepted 31.8% (699 of 2,199) of donor hearts offered. Unlike other centers, the acceptance rate, with or without transplantation, did not increase over time. Of the donor hearts rejected by our center, 38.1% (572 of 1,500) were later accepted elsewhere. Acceptance rates were twice as high for donor hearts initially rejected for non-quality reasons (339 of 601, 56.4%) compared with initial rejection for quality reasons (233 of 899, 25.9%). Three-year patient survival rate was 79% at Vienna; for donor hearts initially rejected by Vienna for non-quality reasons or quality reasons, it was 73% and 63%, respectively (p CONCLUSIONS: A less restrictive policy for accepting donor hearts at our center, particularly regarding rejection for non-quality reasons or for positive virology, high catecholamine levels, longer ischemic time, or low ejection fraction, could expand our donor pool while maintaining good outcomes. (C) 2018 International Society for Heart and Lung Transplantation. All rights reserved.

Background— Left ventricular assist device–supported patients are usually anticoagulated with a combination of aspirin and vitamin K antagonists. Long-term vitamin K antagonist therapy can be complicated by unstable international normalized ratio values and patient-related compliance problems. Therefore, direct thrombin inhibitors may represent an alternative to vitamin K antagonists. Methods and Results— Thirty HeartWare ventricular assist device patients with stable renal function were planned for this prospective, randomized, open-label, single-center study. Patients were randomized to receive either phenprocoumon or dabigatran in addition to aspirin for long-term anticoagulation. Treatment duration was scheduled for 1 year and stopped after observation of a primary end point. Dabigatran dose was 110 and 75 mg BID in patients with normal or impaired renal function (glomerular filtration rate >80 mL/min or between 80 and 30 mL/min, respectively). The study was stopped prematurely for safety reasons after 16 patients (61±8 years, 1 female) were randomized. Thromboembolic events occurred in 4 subjects receiving dabigatran (50%) and in 1 receiving phenprocoumon (13%; P =0.28). No major bleeding was recorded, and no patient died during the study. Median time to treatment termination was significantly shorter in dabigatran patients (8.5 versus 12.0 months; P =0.015). Conclusions— Thromboembolic events on dabigatran led to early termination of a randomized controlled trial of dabigatran versus phenprocoumon in left ventricular assist device patients. Clinical Trial Registration— https://www.clinicaltrials.gov . Unique identifier: NCT02872649.

The overall therapeutic goal of venoarterial extracorporeal membrane oxygenation (ECMO) in patients with postcardiotomy shock is bridging to myocardial recovery. However, in patients with irreversible myocardial damage prolonged ECMO treatment would cause a delay or even withholding of further permanent potentially life-saving therapeutic options. We therefore assessed the prognostic effect of duration of ECMO support on survival in adult patients after cardiovascular surgery.We enrolled into our single-center registry a total of 354 patients who underwent venoarterial ECMO support after cardiovascular surgery at a university-affiliated tertiary care center.Through a median follow-up period of 45 months (interquartile range, 20-81 months), 245 patients (69%) died. We observed an increase in mortality with increasing duration of ECMO support. The association between increased duration of ECMO support and mortality persisted in patients who survived ECMO support with a crude hazard ratio of 1.96 (95% confidence interval, 1.40-2.74; P .001) for 2-year mortality compared with the third tertile and the second tertile of ECMO duration. This effect was even more pronounced after multivariate adjustment using a bootstrap-selected confounder model with an adjusted hazard ratio of 2.30 (95% confidence interval, 1.52-3.48; P .001) for 2-year long-term mortality.Prolonged venoarterial ECMO support is associated with poor outcome in adult patients after cardiovascular surgery. Our data suggest reevaluation of therapeutic strategies after 7 days of ECMO support because mortality disproportionally increases afterward.

Purpose At present the assessment of the heart transplant (HTx) recipient's personal alloimmune risk is still not precise enough. The aim of this study was to evaluate the impact of molecular-level human leukocyte antigen (HLA) matching on post-transplant graft survival, rejection and cardiac allograft vasculopathy (CAV). Methods We retrospectively analyzed all primary cardiac transplant recipients between 01/1984 - 06/2016. 1,167 patients fulfilled inclusion criteria with HLA typing information available for donor and recipient. In 312 pairs high resolution HLA typing at split antigen level was available for AB and DR. We used the HLAMatchmaker algorithm (version 02.1) to calculate amino acid differences in antibody verified HLA epitopes (epitope mismatch load (EpMM)) between donor and recipient. In order to group patients in high and low EpMM, we split the collective at the respective median. Kaplan Meier analyses with log-rank tests were used to compare outcomes between groups. A p-value of Results Patients with a DR EpMM load below the median ( Conclusion HLA matching at the epitope level can serve as tool for risk stratification after heart transplantation and could take us one step further into precision medicine in solid organ transplantation.

OBJECTIVES: Interagency Registry for Mechanical Assisted Circulatory Support (INTERMACS) Level I patients have the highest early mortality after ventricular assist device (VAD) implantation. This is determined by the exposure of patients in shock with acutely damaged end-organs and high catecholamine support to a significant surgical trauma. We report our experience with a bridge-to-bridge concept consisting of initial veno-arterial extracorporeal life support (ECLS) and deferral of VAD implantation to recovery of end-organ function in INTERMACS Level I patients. METHODS: We reviewed the concept of initial ECLS implantation and deferral of VAD implantation to end-organ recovery in 22 consecutive patients (mean age 54 ± 14 years; 72.2% males; 50% ischemic cardiomyopathy; 100% INTERMACS Level I; 18.2% Heartmate II, 68.2% Heartware HVAD, 4.5% Heartware BiVAD, 9.1% DeBakey LVAD) receiving a VAD for refractory cardiogenic shock between June 2004 and February 2013. Study endpoints were end-organ recovery during ECLS and survival. RESULTS: ECLS significantly improved renal (creatinine 1.86 ± 0.91 vs 1.32 ± 0.52 mg/dl, P= 0.02), hepatic (aspartate aminotransferase 1426 ± 2176 vs 277 ± 259 U/l, P= 0.04; alanine aminotransferase 982 ± 1466 vs 357 ± 447 U/l, P= 0.04) and pulmonary functions (fraction of inspired oxygen 52 ± 18 vs 26 ± 23%, P< 0.01; positive end-expiratory pressure 7 ± 3 vs 5 ± 4 mbar, P= 0.02) over a period of 8 ± 7 days. Catecholamines could be reduced during ECLS (levosimendan 0.056 ± 0.085 vs 0.010 ± 0.032 μg/kg/min, P= 0.06; dobutamine 4.362 ± 5.268 vs 0.056 ± 0.097 μg/kg/min, P= 0.06; noradrenaline 0.408 ± 0.355 vs 0.056 ± 0.097 μg/kg/min, P< 0.01). Thirty-day and inhospital mortality after VAD implantation were 4.5 and 9.1%, respectively, and 1-year survival was 86.4%. CONCLUSION: Preoperative patient optimization using ECLS improves outcomes of INTERMACS Level I patients receiving a permanent VAD.

Background Anti-coagulation is required in patients with left ventricular assist devices (LVADs). We evaluated the feasibility of low-molecular-weight heparin (LMWH) for initiation of anti-coagulation and transitioning to oral anti-coagulation after LVAD implantation. Methods This single-center study included 78 consecutive patients who underwent either Thoratec HeartMate II LVAD ( n = 27) or HeartWare ventricular assist device (HVAD, n = 51) implantation. The LMWHs enoxaparin ( n = 50) and dalteparin ( n = 28) were used. LMWH was started within 24 hours post-operatively in 79.5% of patients. No anti-coagulation was given before starting LMWH therapy. LMWH activity was monitored by determination of anti–factor Xa levels in plasma. Results The majority of patients (80.7%) had peak anti-Xa activity within the defined range of efficacy of 0.2 to 0.4 IU/ml by the second day of treatment. Mean effective peak anti-Xa activity was 0.28 ± 0.06 IU/ml. Mean duration of anti-coagulation with LMWH was 25.8 ± 18 days. Ischemic strokes were observed in 3 patients (3.8%), with a total of 4 events. Three events occurred while on LMWH, and 1 event occurred during follow-up on oral anti-coagulation. There was 1 fatal stroke. No pump thrombus was observed. Major bleeding was observed in 5 patients (6.4%), with a total of 6 events. Gastrointestinal bleeding was the most common complication ( n = 3). There were no fatal bleeding events. Conclusions LMWH in the setting of LVAD shows rapid and constant biologic efficacy. Anti-coagulation with LMWH appears feasible after LVAD implantation. These findings support further evaluation of LMWH as an alternative to unfractionated heparin in this patient cohort.

With increasing support duration of cardiac assist devices, transcutaneous drivelines remain a weak point of the therapy. First, they can be an entry point for infections, and second, cable lesions and even electrical failures due to material fatigue and eventual carelessness can occur. We report a case of a damaged outer sheath of a ventricular assist device driveline cable directly at the exit site, where the standard repair procedure with self-fusing tape may lead to biocompatibility problems and irritation of the entrance through the skin. Therefore, a new procedure was developed using a special sleeve expander tool and a highly expandable latex tubing to stabilize the defect in a flexible and biocompatible manner. A patient experienced a fracture of the outer sheath of a HeartWare HVAD driveline directly at the skin entrance (approximately 15 mm long, 5 mm distal from the skin). The metal strands and the electrical functionality were yet not affected, therefore, a pump exchange was not indicated. After considering several conventional solutions for repair as not applicable, a new approach was developed: a sleeve expander tool was applied, which allowed radial stretching of the latex tubing. After preparations of the tool and the cable site, the pump was briefly disconnected, the tubing was moved over the connector and was released at the site of fracture. The problem could be solved by keeping the cable's flexibility and without additional risks to the skin. Within a still ongoing (5-month) follow-up, the skin entrance returned to perfect condition and no further intervention was necessary. In conclusion, this method allows a quick stabilization and repair of damaged driveline isolations even near the exit site, resulting in a biocompatible surface and consistent flexibility of the cable.

OBJECTIVES Right ventricular (RV) failure complicating left ventricular assist device implantation is associated with increased mortality. Despite a lack of supporting evidence, venoarterial extracorporeal membrane oxygenation (ECMO) support is increasingly being used as an alternative to traditional temporary RV support. We report our institutional experience with ECMO-facilitated RV support after left ventricular assist device implantation. METHODS We retrospectively reviewed the concept of temporary ECMO support for perioperative RV failure in 32 consecutive left ventricular assist device (mean age 52 ± 14 years; male 84.4%; ischaemic cardiomyopathy 40.6%; INTERMACS Level I 71.8%; INTERMACS Level II 6.3%; INTERMACS Level III 12.5%; INTERMACS Level IV-VII 9.4%; HeartWare ventricular assist device 75%; HeartMate II: 25%) from May 2009 to April 2014. The study end points were RV recovery during ECMO support, mortality and causes of death. RESULTS Twenty-nine (90.6%) patients were successfully weaned from ECMO support after RV recovery. Three (9.4%) patients expired during ECMO support. ECMO support improved RV function and haemodynamic parameters (central venous pressure 13 mmHg vs 10 mmHg, P

A novel, off-pump implantation technique for the HeartWare ventricular assist device with outflow graft anastomosis to the left subclavican artery is described. Cannulation of the left ventricular apex is performed through an incision in the left fourth or fifth intercostal space. The outflow graft is anastomosed to the left subclavian artery after tunneling through the left thoracic cavity and the first intercostal space. This technique is especially appealing in redo cases as well as in patients with significant calcifications of the ascending aorta or in destination-therapy patients.

Minimally invasive approaches for mitral valve repair are increasingly applied in current clinical practice. Patients admitted to our clinic with suitable diagnoses are routinely screened for a right minithoracotomy and if suitable planned primarily for this approach. Herein we provide details regarding our minimally invasive mitral valve replacement or repair techniques with special emphasis on the cannulation strategy.

New left ventricular assist devices (LVADs) offer both important advantages and potential hazards. VAD development requires better and expeditious ways to identify these advantages and hazards. We validated in an isolated working heart the hemodynamic performance of an intraventricular LVAD and investigated how its outflow cannula interacted with the aortic valve. Hearts from six pigs were explanted and connected to an isolated working heart setup. A miniaturized LVAD was implanted within the left ventricle (tMVAD, HeartWare Inc., Miami Lakes, FL, USA). In four experiments blood was used to investigate hemodynamics under various loading conditions. In two experiments crystalloid perfusate was used, allowing visualization of the outflow cannula within the aortic valve. In all hearts the transapical miniaturized ventricular assist device (tMVAD) implantation was successful. In the blood experiments hemodynamics similar to those observed clinically were achieved. Pump speeds ranged from 9 to 22 krpm with a maximum of 7.6 L/min against a pressure difference between ventricle and aorta of ∼50 mm Hg. With crystalloid perfusate, central positioning of the outflow cannula in the aortic root was observed during full and partial support. With decreasing aortic pressures the cannula tended to drift toward the aortic root wall. The tMVAD could unload the ventricle similarly to LVADs under conventional cannulation. Aortic pressure influenced central positioning of the outflow cannula in the aortic root. The isolated heart is a simple, accessible evaluation platform unaffected by complex reactions within a whole, living animal. This platform allowed detection and visualization of potential hazards.

We report the echocardiographic detection of microbubbles in the outflow prosthesis of a HeartWare HVAD left ventricular assist device using transthoracic echocardiography. In this case it was a specific sign associated with device thrombosis that resolved after successful treatment with systemic thrombolysis.

A minimally invasive approach for implantation of the Heart Mate II left ventricular assist device (LVAD) in the setting of severe thoracic aortic calcification is described. Cannulation of the left ventricular apex is performed through a left subcostal incision with preperitoneal creation of the pump pocket. To avoid outflow graft anastomosis to a severely calcified ascending or descending aorta, the outflow graft is tunneled through the diaphragm, the right thoracic cavity, and the second intercostal space, and is anastomosed to the right subclavian artery. This technique is especially appealing in patients with generalized aortic calcification undergoing LVAD implantation.

End-stage heart failure represents a substantial worldwide problem for the healthcare system. Despite significant improvements (medical heart failure treatment, implantable cardioverters, cardiac resyschronisation devices), long-term survival and quality of life of t ese patients remains poor. Heart transplantation has been an effective therapy for terminal heart failure, but it remains limited by an increasing shortage of available donor organs along with strict criteria defining acceptable recipients. For the last 50 years, mechanical alternatives to support the circulation have been investigated; however, during the early years device development has been marked in general by slow progress. However, in the past two decades, the technology has evolved dramatically. The purpose of this review is to give a short summary on the evolution of ventricular assist device (VAD) therapy and to give perspectives for future treatment of heart failure.

OBJECTIVE: Avoiding full sternotomy and cardiopulmonary bypass (CPB) could significantly reduce the invasiveness of left ventricular assist device (LVAD) implantation. Therefore, we developed minimally invasive implant strategies for the Heartware® VAD (HVAD) and the Thoratec® HeartMate II (HMII) covering isolated LVAD implantation as well as concomitant valve procedures (aortic/tricuspid). We present the surgical techniques and the initial clinical experience. METHODS: From February 2012 to March 2013, 27 patients (mean age 58 ± 8 years; male 85%; Ischemic Cardiomyopathy 63%; redo surgery 22%; Interagency Registry for Mechanically Assisted Circulatory Support Level I: 29%, II: 22%, III: 33%, IV–VII: 16%) underwent minimally invasive LVAD implantation at our department. Apical cannulation was performed via a left lateral minithoracotomy in HVAD patients (n= 20) or a left subcostal incision in HMII patients (n= 7). The outflow graft anastomosis was performed to the ascending aorta via a right minithoracotomy in the second intercostal space (n= 22) or the right subclavian artery (n= 2). If additional valve procedures (aortic/tricuspid) were necessary (n= 3), a hemisternotomy was performed to access the valve and perform the outflow graft anastomosis. Circulatory support for LVAD implantation was CPB (33%), extracorporeal membrane oxygenation (48%) or off-pump (19%). RESULTS: The minimally invasive approach was feasible in all patients with no need for conversions. Thirty-day and in-hospital mortality were 7.4 and 14.8%, respectively. In-hospital stay was 30.0 ± 22.5 days. One patient (4%) died during follow-up from pump thrombus formation. Three patients (11%) underwent surgical revision for bleeding. CONCLUSIONS: Minimally invasive LVAD implantation is feasible and safe. The very encouraging results obtained in this initial series justify a broad application of this technique.

With increasing support duration of cardiac assist devices, transcutaneous drivelines remain a weak point of the therapy. First, they can be an entry point for infections, and second, cable lesions and even electrical failures due to material fatigue and eventual carelessness can occur. We report a case of a damaged outer sheath of a ventricular assist device driveline cable directly at the exit site, where the standard repair procedure with self-fusing tape may lead to biocompatibility problems and irritation of the entrance through the skin. Therefore, a new procedure was developed using a special sleeve expander tool and a highly expandable latex tubing to stabilize the defect in a flexible and biocompatible manner. A patient experienced a fracture of the outer sheath of a HeartWare HVAD driveline directly at the skin entrance (approximately 15 mm long, 5 mm distal from the skin). The metal strands and the electrical functionality were yet not affected, therefore, a pump exchange was not indicated. After considering several conventional solutions for repair as not applicable, a new approach was developed: a sleeve expander tool was applied, which allowed radial stretching of the latex tubing. After preparations of the tool and the cable site, the pump was briefly disconnected, the tubing was moved over the connector and was released at the site of fracture. The problem could be solved by keeping the cable's flexibility and without additional risks to the skin. Within a still ongoing (5-month) follow-up, the skin entrance returned to perfect condition and no further intervention was necessary. In conclusion, this method allows a quick stabilization and repair of damaged driveline isolations even near the exit site, resulting in a biocompatible surface and consistent flexibility of the cable.