First-in-Man Use of the Percutaneous 10F Reitan Catheter Pump for Cardiorenal Syndrome.

Cardiorenal syndrome worsens outcome in patients with decompensated chronic heart failure, and complicates recompensation by medical therapy. Mechanical circulatory support has the potential to improve renal function, and likely mitigates diuretic resistance in patients with severe cardiorenal syndrome. The Reitan catheter pump (RCP) is a novel temporary percutaneous circulatory support system for reducing cardiac afterload and increasing renal preload. Here, we report on the first-in-man use of the 10F-version of the RCP device, which was associated with favorable effects on hemodynamics and diuresis. Further investigation to evaluate safety and efficacy of this promising approach is warranted.

Is there a sex gap in outcomes of comparable patients supported with left ventricular assist devices?

OBJECTIVES: Historically, females were described as suffering from worse outcomes after left ventricular assist device (LVAD) implantation. However, females' preoperative conditions are unique, making direct comparisons with males challenging. This study aimed to select through propensity score (PS) matching two preoperatively comparable populations of females and males and test if any real sex-related difference exists regarding survival and adverse events after LVAD implantation. METHODS: This retrospective single-center observational study investigated patients who received LVAD implantation between 2010 and 2018. PS matching was applied to balance preoperative heterogeneity between males and females. Primary endpoint was survival at follow-up. Secondary endpoints included perioperative outcomes and LVAD-related adverse events. RESULTS: 92 fully comparable females(n = 46) and males(n = 46) were selected after PS matching (median age:57 years, min-max:18-75). 26.1% of patients required preoperative mechanical circulatory support. Females needed more intraoperative fresh frozen plasma (p < 0.001) and platelets transfusions (p = 0.008) compared to males, but postoperative outcomes were comparable between groups. In-hospital, 1 and 2-year survival were 78.3%, 69.6% and 65.2%, respectively, with no differences between groups. Survival probability remained comparable up to 8 years of follow-up (p = 0.35). Overall, females showed a higher rate of strokes (p = 0.039) compared to males in the follow-up time. CONCLUSIONS: After reducing preoperative heterogeneity between females and males, survival after LVAD implantation does not differ based on sex. However, differences might exist in terms of higher transfusions and strokes in females. Reducing preoperative sex disparities and developing intraoperative and anticoagulation strategies which acknowledge sex-related variations might help abolishing differences in LVAD outcomes.

First-in-man Implantation of a Cardiac Microcurrent Device for Chronic Systolic Heart Failure.

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.

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

BACKGROUND: Worse outcomes in women compared to men undergoing left ventricular assist device (LVAD) implantation remain an underestimated problem in heart failure (HF) patients. With device miniaturization, less-invasive LVAD implantation techniques have gained relevance, but their impact on outcomes in women is unknown. This study investigates sex-related differences in patients undergoing LVAD implantation through less-invasive procedures. METHODS: This retrospective single-center cohort study included patients who underwent isolated LVAD implantation between 2011 and 2018 through less-invasive techniques. Propensity score matching (PSM) was utilized to balance preoperative heterogeneity. Primary endpoint was two-year survival, and secondary endpoints included long-term survival, surgical outcomes and postoperative adverse events. RESULTS: Baseline analysis of 191 patients (females 18.3%) showed differences in terms of age [female (median, 52; IQR, 47-61); male (median, 58.5; IQR, 49-66); P=0.005], underlying diagnosis (P<0.001), INTERMACS profile (P=0.009), history of previous cardiac surgery (P=0.049) and preoperative creatinine values [female (median, 110; IQR, 71-146); male (median, 126; IQR, 9-168); P=0.049]. Over a follow-up of 460.68 patient-years, Kaplan-Meyer analysis showed better survival in females (P=0.027) and a similar probability of cardiac transplantation (P=0.288). After PSM, females showed higher needs for intraoperative fresh frozen plasma (P=0.044) and platelets (P=0.001) but comparable postoperative outcomes. No sex-related differences were noticed regarding two-year outcomes, long-term survival and adverse events. LVAD-related infections remained the most common complication with males experiencing more pump infections than women (P=0.050). CONCLUSIONS: Patients receiving less-invasive LVAD implantation do not show significant sex-related differences in short and long-term outcomes and survival. Prospective studies are needed to evaluate the role of less-invasive techniques in reducing sex-based disparities after LVAD implantation.

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

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

Lateral Thoracotomy for Ventricular Assist Device Implantation: A Meta-Analysis of Literature.

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

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

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

Mechanical circulatory support for life-threatening arrhythmia: A systematic review.

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.

MitraClip procedure prior to left ventricular assist device implantation.

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

Clinical overview of the HVAD: a centrifugal continuous-flow ventricular assist device with magnetic and hydrodynamic bearings including lateral implantation strategies.

Growing worldwide incidences of end-stage heart failure and declining rates of cardiac transplants have given rise to the need for alternative treatment options, based on mechanical circulatory support (MCS) devices such as left ventricular assist devices (LVADs). Technologically advanced LVADs such as the HVAD® (HeartWare®, Medtronic) facilitate safe and efficient treatment of heart failure patients with reduced post-operative complications, which is attributed to their considerably miniaturized size. This also facilitates the development and implementation of novel, minimally-invasive surgical techniques. The HVAD is a centrifugal pump, manufactured by HeartWare Inc., (Framingham, MA, USA) and subsequently by Medtronic Inc., (Minnesota, MN, USA), and has been approved for clinical application after receiving the CE Mark approval in 2008 and the FDA approval in 2012. Current research efforts are focused on further miniaturization alongside optimization of electronic and software controllers as well as implementation of the transcutaneous energy transfer (TET) technology. Salient features of the HVAD pump technology, clinical applications and future optimization strategies have been discussed in this article.

The momentum of HeartMate 3: a novel active magnetically levitated centrifugal left ventricular assist device (LVAD).

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.

A new tool for an explantation strategy of HeartMate 3™ left ventricular assist device.

Although rare, recovery of cardiac function after mechanical support of the left ventricle is the most desirable therapeutic goal in the treatment of end-stage heart failure.Herein, we present a novel implantable device for explantation of the HeartMate 3™ left ventricular assist device (LVAD) in patients, following cardiac recovery, avoiding (re-) sternotomy.This article demonstrates the feasibility of applying this novel device, which fits into the sewing ring of the LVAD.This custom-made mechanical plug offers a promising alternative to standard device-explantation procedures.

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

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

Repair of left ventricular driveline tear in a SynCardia-total artificial heart patient.

We report the case of a 64-year old Caucasian male patient with a tear of the left ventricular driveline just above the driveline-air tube junction. We describe the repair technique and the necessary set of tools.

Veno-venous extracorporeal membrane oxygenation with a bicaval dual-lumen catheter in a SynCardia total artificial heart patient.

We report the case of a 55 years old caucasian male patient with cardiogenic shock due to an extended myocardial infarction who underwent SynCardia Total Artificial Heart implantation and veno-venous extracorporeal membrane oxygenation with a bicaval dual-lumen cannula for the treatment of adult respiratory distress syndrome.