Use of implantable cardioverter-defibrillator in children supported with ventricular assist device: An analysis of data from the EUROMACS registry.

BACKGROUND: Data on the use and outcome of children on ventricular assist device (VAD) support provided with an implantable cardioverter-defibrillator (ICD) remains poor. METHODS: A retrospective analysis of the EUROMACS database on children supported with VAD < 19 years of age from January 1, 2009 to April 1, 2020. Patients with missing data on status of ICD, missing baseline and/or follow up information were excluded. The primary independent variable of interest was the concomitant presence or absence of an ICD at the time of VAD placement. Kaplan-Meier survival analysis was performed to evaluate survival differences between children on VAD with and without an ICD. RESULTS: Out of 303 patients provided with a VAD, 7% (7♀, 15♂) had an ICD implanted and formed the study group. Median age was 14 years, median weight was 43.5 kg, and median BSA was 1.39. Median Intermacs stage was 2 (range: 1-7). Seventeen patients (77%) were transplanted, 4 (18%) died while on support, and 1 (5%) was weaned from device after myocardial recovery. Median time on support was 68 days compared to 361 days in the control group (p: 0.01). Three patients underwent device exchange due to thrombus formation in the pump. There was no difference in survival between groups (p = 0.342). CONCLUSION: The presence of ICD in pediatric patients supported with a VAD is low (7%). Children on VAD support provided with an ICD do not have a survival benefit compared to children without an ICD.

An Emergency Medicine-focused Summary of the HFSA/SAEM/ISHLT Clinical Consensus Document on the Emergency Management of Patients With Ventricular Assist Devices.

Mechanical circulatory support is increasingly used as a long-term treatment option for patients with end-stage heart failure. Patients with implanted ventricular assist devices are at high risk for a range of diverse medical urgencies and emergencies. Given the increasing prevalence of mechanical circulatory support devices, this expert clinical consensus document seeks to help inform emergency medicine and prehospital providers regarding the approach to acute medical and surgical conditions encountered in these complex patients.

Results of primary biventricular support: an analysis of data from the EUROMACS registry.

OBJECTIVES: The purpose of this study was to describe pre- and postoperative data from the EUROMACS registry with regard to indications, for and survival and complication rates of patients with primary continuous flow and pulsatile biventricular long-term assist devices (BiVADs) versus total artificial hearts (TAHs) or left ventricular assist devices (LVADs) + short-term right ventricular assist device (RVAD) implants. METHODS: We investigated patients who received implants between 1 January 2011 and 21 October 2017. Clinical baseline information about comorbidities, laboratory results, medical and device therapies and echocardiographic, haemodynamic and right ventricle (RV) parameters were evaluated along with the rates of deaths and complications. RESULTS: A total of 413 of 3282 patients (12.5%) needed a biventricular pump. We investigated 37 long-term BiVADs, 342 LVAD + short-term RVAD implants and 34 TAHs. Minor differences were found in the baseline characteristics of our population, which had an overall high morbidity profile. The 1-year survival rate was 55% for patients with a continuous flow BiVAD; 52% for patients with an LVAD + short-term RVAD; 37% for patients with pulsatile BiVADs; and 36% for patients with a TAH. No statistical difference was observed among the groups. Over 50% of patients with BiVAD support were classified as INTERMACS profiles 1 and 2. The percent of patients with ambulatory heart failure (INTERMACS 4‒7) undergoing BiVAD implants was modest at <15%. No patients with a pulsatile BiVAD (n = 15) or a TAH (n = 34) were implanted as destination therapy, but 27% of the patients with continuous flow BiVADs (n = 6) and 23% of the patients with LVAD + short-term RVAD (n = 342) were implanted as 'destination'. The adverse events profile remained high, with no significant difference among pump types. The right ventricular stroke work index and right heart failure scores indicated poor RV function in all groups. After 3 months of LVAD + short-term RVAD support, 46.7% still required ongoing support, and only 18.5% were weaned from RVAD support; 33.1% died. CONCLUSIONS: The mortality rate after BiVAD support was high. Survival rates and adverse events were statistically not different among the investigated groups. In the future, composite study end points examining quality of life and adverse events beyond survival may help in shared decision-making prior to general mechanical circulatory support, particularly in patients with BiVAD implants.

HFSA/SAEM/ISHLT Clinical Expert Consensus Document on the Emergency Management of Patients with Ventricular Assist Devices.

Mechanical circulatory support is now widely accepted as a viable long-term treatment option for patients with end-stage heart failure (HF). As the range of indications for the implantation of ventricular assist devices grows, so does the number of patients living in the community with durable support. Because of their underlying disease and comorbidities, in addition to the presence of mechanical support, these patients are at a high risk for medical urgencies and emergencies (Table 1). Thus, it is the responsibility of clinicians to understand the basics of their emergency care. This consensus document represents a collaborative effort by the Heart Failure Society of America, the Society for Academic Emergency Medicine, and the International Society for Heart and Lung Transplantation (ISHLT) to educate practicing clinicians about the emergency management of patients with ventricular assist devices. The target audience includes HF specialists and emergency medicine physicians, as well as general cardiologists and community-based providers.

HFSA/SAEM/ISHLT clinical expert consensus document on the emergency management of patients with ventricular assist devices.

Mechanical circulatory support is now widely accepted as a viable long-term treatment option for patients with end-stage heart failure (HF). As the range of indications for the implantation of ventricular assist devices grows, so does the number of patients living in the community with durable support. Because of their underlying disease and comorbidities, in addition to the presence of mechanical support, these patients are at a high risk for medical urgencies and emergencies (Table 1). Thus, it is the responsibility of clinicians to understand the basics of their emergency care. This consensus document represents a collaborative effort by the Heart Failure Society of America, the Society for Academic Emergency Medicine, and the International Society for Heart and Lung Transplantation (ISHLT) to educate practicing clinicians about the emergency management of patients with ventricular assist devices. The target audience includes HF specialists and emergency medicine physicians, as well as general cardiologists and community-based providers.

The Utility of a Wireless Implantable Hemodynamic Monitoring System in Patients Requiring Mechanical Circulatory Support.

Proper timing of left ventricular assist device (LVAD) implantation in advanced heart failure patients is not well established and is an area of intense interest. In addition, optimizing LVAD performance after implantation remains difficult and represents a significant clinical need. Implantable hemodynamic monitoring systems may provide physicians with the physiologic information necessary to improve the timing of LVAD implantation as well as LVAD performance when compared with current methods. The CardioMEMS Heart sensor Allows for Monitoirng of Pressures to Improve Outcomes in NYHA Class III heart failure patients (CHAMPION) Trial enrolled 550 previously hospitalized patients with New York Heart Association (NYHA) class III heart failure. All patients were implanted with a pulmonary artery (PA) pressure monitoring system and randomized to a treatment and control groups. In the treatment group, physicians used the hemodynamic information to make heart failure management decisions. This information was not available to physicians for the control group. During an average of 18 month randomized follow-up, 27 patients required LVAD implantation. At the time of PA pressure sensor implantation, patients ultimately requiring advanced therapy had higher PA pressures, lower systemic pressure, and similar cardiac output measurements. Treatment and control patients in the LVAD subgroup had similar clinical profiles at the time of enrollment. There was a trend toward a shorter length of time to LVAD implantation in the treatment group when hemodynamic information was available. After LVAD implantation, most treatment group patients continued to provide physicians with physiologic information from the hemodynamic monitoring system. As expected PA pressures declined significantly post LVAD implant in all patients, but the magnitude of decline was higher in patients with PA pressure monitoring. Implantable hemodynamic monitoring appeared to improve the timing of LVAD implantation as well as optimize LVAD performance when compared with current methods. Further studies are necessary to evaluate these findings in a prospective manner.

Left atrial appendage closure for "primary primary" prevention during percutaneous closure of septal defects in patients with large atria but no atrial fibrillation.

BACKGROUND: Percutaneous atrial septal defect (ASD) closure is a routine procedure to prevent right ventricular failure, pulmonary hypertension, or paradoxical embolism. The latter is the typical reason for percutaneous patent foramen ovale (PFO) closure. Atrial enlargement represents a risk for develop-ing atrial fibrillation (AF). Percutaneous left atrial appendage (LAA) closure is emerging as a preven-tive therapy for patients in AF who suffered from a previous stroke or bleeding (secondary prevention) or patients without previous stroke or bleeding (primary prevention). Percutaneous septal closure, particularly that of large ASDs, may inhibit future percutaneous left atrial access when required for LAA closure. Reported herein is the feasibility and safety of concomitant percutaneous closure of the LAA and a septal shunt, mostly large ASDs, in patients without AF, in the sense of "primary primary" preventive LAA closure. The first "primary" relates to "in anticipation of AF" and potentially also for "for prevention of AF". The second "primary" relates to "prevention of stroke or bleeding". METHODS: Thirteen consecutive patients, older than 40 years without any clinical or electrocardio-graphic evidence of AF, underwent percutaneous closure of large ASDs or PFOs in the presence of enlarged atria at the university hospitals of Bern and Zurich between April 2013 and June 2015. They concomitantly received "primary primary" preventive LAA closure after informed consent. RESULTS: Mean patient age was 58 ± 9 years (46% male). Procedural success was achieved in all pa-tients and no major adverse events occurred acutely or during the following 2.0 ± 0.8 years. No patient developed AF. CONCLUSIONS: Concomitant closure of ASD or PFO in the presence of enlarged atria and LAA for "primary primary" prevention appears feasible and safe but has yet to prove its justification.

Emergency procedures for patients with a continuous flow left ventricular assist device.

The number of ventricular assist devices (VADs) being implanted for terminal heart failure is rising at an exponential rate. These implanted patients have a decreased mortality, but still have significant morbidities, as the prevalence of these patients increases in the community. When VAD patients are discharged to home, they will very likely require emergency medical services (EMSs) and emergency medical doctors (EDs) with their future care. The interface of these patients with the community would suggest an increasing prevalence of encounters requiring the need for acute medical care. This will place the initial responsibility of these patients in the hands of EMS first responders and emergency room providers. To date, there is very little literature published on out-of-hospital or ED care for VAD patients. Most EMS personnel and ED feel uncomfortable treating a patient with a VAD because they have not had sufficient exposure. The cardiovascular treatment of VAD patients in the field can pose different challenges typically encountered including difficulties measuring a pulse and sometimes undetectable BP. Despite these unique challenges, official guidelines or even standard operating procedures regarding the emergency treatment of VAD patients are still lacking. We present a basic overview of the most commonly used left VAD systems and propose guidelines that should be followed in the event of an emergency with a VAD patient out of hospital.

Mid-term mechanical circulatory support: comparison of single-centre data with the EUROMACS registry.

OBJECTIVES: Mechanical circulatory support (MCS) is an established therapy for end-stage heart failure. The EUROMACS registry was created to promote research in patients with MCS and became a committee of the European Association for Cardio-Thoracic Surgery (EACTS) in 2014. Since 1 January 2011, increasing numbers of European centres implanting durable MCS have reported their patient data to EUROMACS. The aim of this study is to compare, as an example of internal quality control, data from a single centre (Bern) with those from the EUROMACS database with respect to mortality rates and preoperative patient characteristics and to describe complications in Bern. METHODS: Patients implanted with MCS between 1 January 2011 and 30 June 2014 in participating centres were included, with extended follow-up as of 31 December 2014. Patient characteristics, operative and postoperative data, clinically significant adverse events and routine follow-up data were reported to the registry. The entire EUROMACS cohort (including the Bern data) was compared with patients from Bern only. Baseline characteristics, operative data and outcomes were compared using standard 95% confidence intervals (CIs) for means, Wilson's continuity corrected CIs for categories and Kaplan-Meier estimates with CIs. RESULTS: Kaplan-Meier estimates show a higher survival rate in the Bern cohort than in the entire EUROMACS cohort at 6 (92%, CI 73-98, vs 66%, CI 62-69), 12 (85%, CI 57-95, vs 56%, CI 52-60) and 18 months (85%, CI 57-95, vs 51%, CI 47-55) after the index operation, respectively. This difference might be caused by the earlier implantation time in Bern (implantation at INTERMACS levels 3-4) versus that of the entire EUROMACS cohort (implantation at INTERMACS levels 2-3). The median number of follow-up records per patient was 2 in the entire EUROMACS cohort and 4 in the Bern (P = 0.001) cohort. During follow-up, neurological dysfunction occurred in 42% of patients, a bleeding event occurred in 42% of patients, significant infection occurred in 36% of patients and a device malfunction occurred in 31% of patients within 12 months of implantation in the Bern patients. CONCLUSIONS: MCS is a valuable therapeutic option with excellent survival rates; nevertheless, it is associated with clinically significant complication rates. International registries are important tools that allow, as an example, internal quality control of mortality, complication and morbidity rates from a single centre compared with the EUROMACS database.

Design changes in continuous-flow left ventricular assist devices and life-threatening pump malfunctions.

OBJECTIVES: The implantable continuous-flow left ventricular assist devices (LVADs) HeartMate II (HM II) and HeartWare HVAD (HW) underwent design modifications. The impact of these changes on life-threatening pump malfunctions was evaluated. METHODS: We retrospectively analysed pump malfunctions due to thrombosis or cable damage in patients supported with primarily implanted HM II (n = 191) and HW (n = 347), separated into patients supported with the old and new pump designs. In 2010, the cable strain relief of the HM II device was improved (132 patients with old and 79 with new) and sealed grafts were introduced (68 patients with sealed inflow connector and outflow graft and 125 without). In 2011, titanium sintering of the inflow cannula of HW pumps was introduced (137 patients with a non-sintered and 210 with a sintered inflow cannula). RESULTS: The median support time was 1.12 (0-6.1) years for all HM II and 0.59 (0-4.2) years for all HW patients. The cumulative rate of events per patient-year (EPPY) was 0.11 in HM II patients, compared with 0.09 EPPY in HW patients (P = 0.32). After introduction of the new cable design, incidence of cable damage in HM II patients dropped from 0.06 to 0 EPPY (P = 0.03), whereas pump thrombosis increased from 0.02 to 0.14 EPPY (P < 0.001) after the sealed graft was introduced. Pump thrombosis occurred in 4% of patients supported with HW with a sintered inflow cannula vs 15% with a non-sintered pump; the incidence changed from 0.10 to 0.07 EPPY in sintered pumps (P = 0.45). Kaplan-Meier analysis showed no differences over a period of 2.5 years for events when the HM II cohort with sealed graft and new cable design (n = 68) was compared with the HW group with a sintered cannula (P = 0.14). CONCLUSIONS: The modified cable strain relief of the HM II pump and the sintering of the inflow cannula of the HW pump demonstrated a significant reduction in the incidence of life-threatening pump-related complications, whereas the sealed inflow connector and outflow graft seem to be associated with a higher incidence of pump thrombosis. However, the overall incidence of pump-related complications after the latest design changes was similar for both pumps over a 2.5-year period.

Surgical treatment of intraparenchymal hemorrhage during mechanical circulatory support for heart-failure--a single-centre experience.

BACKGROUND: Cranial intraparenchymal hemorrhage represents a critical complication of mechanical circulatory support requiring constant antithrombotic treatment. Surgery of intraparenchymal hemorrhage under anticoagulation represents a challenge and imposes significant risks for patients. It was the aim to analyse surgical and clinical outcome of patients requiring surgical treatment due to intraparenchymal hemorrhage. METHODS: Patients with mechanical circulatory support requiring surgical therapy due to space-occupying lobar supratentorial or infratentorial hemorrhage from January 1, 2009 to January 1, 2014 were included in our study. Baseline parameters are preoperative International Normalized Ratio (INR) values, postoperative anticoagulation regiment, bleeding size and localization. Co-primary outcome parameters were the extent of hematoma evacuation and the Modified Rankin Scale at discharge from hospital. Secondary outcome parameters included rate of recurrent hemorrhage, rate of revision surgery and in-hospital mortality. RESULTS: Twelve patients (mean age 44 ± 18 years, nine supratentorial-/three infratentorial hemorrhages, 11 left ventricular assist devices, and one extracorporeal membrane oxygenation) were included. Surgical hematoma evacuation was performed in 11 patients, one patient received decompressive hemicraniectomy. Hematoma evacuation was complete in no patients, and partial in 11 patients. Initial INR was 2,7 ± 1,6. Rate of recurrent hemorrhage was 75 %. Revision surgery was performed in three patients achieving partial hematoma evacuation in two patients and complete evacuation in one patient. Modified Rankin Scale at discharge from hospital was six in nine patients (in-hospital mortality of 75 %), five in two patients and four in one patient. CONCLUSIONS: Surgical treatment of life threatening, space-occupying intraparenchymal hemorrhage under mechanical circulation support is of limited efficacy with high rates of recurrent hemorrhage and in-hospital mortality. We provide additional data that postponing anticoagulation is feasible and may lead to improved clinical outcome and survival.

Load dependency of right ventricular performance is a major factor to be considered in decision making before ventricular assist device implantation.

BACKGROUND: Left ventricular assist devices (LVADs) provide better outcome than biventricular devices, but it is a challenge to predict the impact of LV mechanical unloading on postoperative right ventricular (RV) function preoperatively. We assessed the load dependency in RV performance before and after LVAD implantation aiming to improve preoperative decision making. METHODS AND RESULTS: Laboratory, echocardiography, and right heart catheterization data collected from 205 patients before LVAD implantation were tested for relationship with postoperative RV function. Comparing patients with different time-course of RV function after LVAD implantation, we found significant differences (P<0.01) in preoperative RV end-diastolic short-/long-axis and long-axis/length-area ratios, tricuspid annulus peak systolic velocity, RV peak longitudinal global systolic strain rate, systolic pressure gradient between RV and right atrium (ΔPRV-RA), tricuspid regurgitation velocity-time integral, and pulmonary arterial pressure between patients with and without postoperative RV failure. High predictive values for postoperative RV failure were found for end-diastolic short-/long-axis ratio ≥ 0.6, tricuspid annulus peak systolic velocity <8 cm/s, and peak systolic longitudinal strain rate <0.6/s in patients with maximum ΔPRV-RA <35 mm Hg. These parameters also seemed predictive for RV failure in patients with tricuspid regurgitation grade >2 and pulmonary arterial pressure <50 mm Hg. End-diastolic short-/long-axis ratio <0.6, tricuspid annulus peak systolic velocity ≥ 8 cm/s, and peak systolic longitudinal strain rate ≥ 0.6 in patients with maximum ΔPRV-RA ≥ 35 mm Hg showed high predictive values for postoperative freedom from RV failure. The RV load adaptation index seemed particularly predictive for RV function after LVAD implantation. CONCLUSIONS: RV geometry and velocity of contraction before LVAD implantation become more predictive for postoperative RV function and can improve decision making before VAD implantation if preoperative RV pressure load and tricuspid regurgitation are also considered.

Management of complications in long-term LVAD support.

INTRODUCTION: Management of complications in long-term LVAD support like aortic regurgitation, progressive decline of right ventricular function, or pump thrombosis are challenging.
 METHODS AND RESULTS: After 2.5 years on a HeartMate II left ventricular assist device (LVAD) a 59-year-old patient was admitted to hospital due to severe hemolysis caused by a partial occlusion and thrombosis caused by a shift of the LVAD inflow cannula towards the lateral wall of the left ventricle (LV). Preoperative assessment revealed additional severe aortic regurgitation and impaired right ventricular (RV) function (severe tricuspid regurgitation, RV ejection fraction 25%, central venous pressure 14 mmHg). After LVAD device exchange and aortic valve replacement (AVR) RV failure occurred and a temporary right ventricular assist device (RVAD) was employed. RVAD explantation was feasible 21 days after surgery. The patient was discharged to a rehabilitation center.
 DISCUSSION: In this case, LVAD exchange with concomitant AVR and temporary RVAD efforts saved the patient's life and restored a good quality of life.

Pump exchange for cable damage in patients supported with HeartMate II left ventricular assist device.

Implantable continuous flow pumps are a routine treatment for end-stage heart failure. The waiting time for heart transplantation is increasing, and more and more patients receive the pump for permanent support. We retrospectively analyzed our database of patients supported with the HeartMate II left ventricular assist device to identify instances of cable damage. Between May 9, 2006 and May 9, 2012, 161 patients were supported with the HeartMate II. There were 187 cumulative years of HeartMate II support. The documented cable damage occurred in 12 patients (7.5%), requiring pump exchange in five patients after a mean time of 706 days on support. There was no perioperative mortality. The damage occurred typically at the "weak" place-the feedthrough of the driveline to the pump body. In some cases, the device alarm history and x-ray may allow diagnosis before pump stop occurs. However, since the most recent changes in the design of the connection and modifications made in the implantation technique, no instance of cable damage has been registered.

Expeditious and less traumatic explantation of a heartware LVAD after myocardial recovery.

After 169 days on left ventricular assist device (LVAD) support, a 62-year-old male patient suffering from idiopathic dilatative cardiomyopathy showed signs of left ventricular recovery. Off-pump trials were done, and our explantation criteria were met. The LVAD removal procedure was performed after 338 days on the device, using a left lateral thoracotomy in the sixth intercostal space. First, the outflow graft was transected and the distal end was sewed. Then, the pump was replaced by an individually manufactured titanium plug. Finally, the driveline was cut so that the device could be completely withdrawn. The rest of the driveline was accessed through a small abdominal incision and explanted through the percutaneous exit site.

Prehospital care of left ventricular assist device patients by emergency medical services.

Left ventricular assist devices (LVADs) are frequently implanted as permanent (bridge to destination [BTD]) or temporary (bridge to transplantation [BTT]) cardiac support. When LVAD patients are discharged to home, they are very likely to require emergency medical services (EMS), but there is very little literature on out-of-hospital emergency care for patients with LVADs. We present two typical cases of LVAD patients for whom EMS was called. In the first case, the patient was in an ambulance two hours distant from our university hospital when a pulsatile system malfunctioned. In the second case, EMS was called to an unconscious LVAD patient. Emergency reference cards, training programs for emergency medical staff, and a 24-hour emergency hotline for the local VAD team are advisable.