Search

BACKGROUND There is little insight into which patients can be weaned off right ventricular (RV) acute mechanical circulatory support (AMCS) after left ventricular assist device (LVAD) implantation. We hypothesize that concomitant RV AMCS insertion instead of postoperative implantation will improve 1-year survival and increase the likelihood of RV AMCS weaning. METHODS A multicenter retrospective database of 826 consecutive patients who received a HeartMate II or HVAD between January 2007 and December 2016 was analyzed. We identified 91 patients who had early RV AMCS on index admission. Cox proportional-hazards model was constructed to identify predictors of 1-year mortality post-RV AMCS implantation and competing risk modeling identified RV AMCS weaning predictors. RESULTS There were 91 of 826 patients (11%) who required RV AMCS after CF-LVAD implantation with 51 (56%) receiving a concomitant RV AMCS and 40 (44%) implanted with a postoperative RV AMCS during their ICU stay; 48 (53%) patients were weaned from RV AMCS support. Concomitant RV AMCS with CF-LVAD insertion was associated with lower mortality (HR 0.45 [95% CI 0.26-0.80], p = 0.01) in multivariable model (which included age, BMI, angiotensin-converting enzyme inhibitor use, and heart transplantation as a time-varying covariate). In the multivariate competing risk analysis, a TPG < 12 (SHR 2.19 [95% CI 1.02-4.70], p = 0.04) and concomitant RV AMCS insertion (SHR 3.35 [95% CI 1.73-6.48], p < 0.001) were associated with a successful wean. CONCLUSIONS In patients with RVF after LVAD implantation, concomitant RV AMCS insertion at the time of LVAD was associated with improved 1-year survival and increased chances of RV support weaning compared to postoperative insertion.

Introduction Electromagnetic interference (EMI) from left ventricular assist devices (LVADs) can cause implantable cardioverter-defibrillator (ICD) oversensing. We sought to assess the frequency of inappropriate shocks/oversensing due to LVAD-related EMI and prospectively compare integrated (IB) versus dedicated bipolar (DB) sensing in patients with LVADs. Methods Single-center study in LVAD patients with Medtronic or Abbott ICDs between September 2017 and March 2020. We excluded patients that were pacemaker dependent. Measurements were obtained of IB and DB sensing and noise to calculate a signal-to-noise ratio (SNR). Device checks were reviewed to assess appropriate and inappropriate sensing events. Results Forty patients (age 52 ± 14 years, 75% men, 38% ischemic cardiomyopathy) were included with the median time between LVAD implantation and enrollment of 6.7 months [2.3, 11.4 months]. LVAD subtypes included: HeartWare (n=22, 55%), Heartmate II (n=10, 25%), and Heartmate III (n=8, 20%). Over a follow-up duration of 21.6 ± 12.9 months after LVAD implantation, 5% of patients (n=2) had oversensing of EMI from the LVAD (both with HeartWare LVADs and Abbott ICDs) at 4 days and 10.8 months after LVAD implantation. Both patients underwent adjustment of ventricular sensing with resolution of oversensing and no further events over 5 and 15 months of further follow-up. The SNR was similar between IB and DB sensing (50 [29-67] and 57 [41-69], p=0.89). Conclusion ICD oversensing of EMI from LVADs is infrequent and can be managed with reprogramming the sensitivity. There was no significant difference in the R-wave SNR with IB versus DB ICD leads. This article is protected by copyright. All rights reserved.

An 82-year-old man with a HeartMate II left ventricular assist device presented with low-flow alarms and cardiogenic shock secondary to left ventricular assist device outflow graft obstruction. Given high risk for redo sternotomy, the heart team decided on percutaneous intervention with peripheral stents, a procedure that is currently limited to case reports. (Level of Difficulty: Advanced.), Central Illustration

Despite improved outcomes of modern continuous-flow left ventricular assist devices (CF-LVADs), device exchange is still needed for various indications. While the majority of CF-LVADs are exchanged to the same model, exchange to a different pump model is occasionally warranted. In this meta-analysis, we sought to consolidate the existing evidence to better elucidate the indications and outcomes in these cases. A comprehensive systematic search of adult patient cohorts who underwent CF-LVAD exchange to a different CF-LVAD model was performed. Study-level data from 10 studies comprising 98 patients were extracted and pooled for analysis. Mean patient age was 58 (95% CI: 48-65) and 81% were male. Indication for initial CF-LVAD was ischemic cardiomyopathy in 45% (34-57). Initial device was HeartMate II LVAD (HMII) in 93 (94.9%) and HeartWare HVAD (HW) in 5 (5.1%) patients. After mean CF-LVAD support time of 18.8 (15.2-22.4) months, exchange indications included thrombosis in 71% (43-89), infection in 21% (8-47) and device malfunction in 12% (7-21). HMII to HW exchange occurred in 53 (54.1%) patients, HMII to HeartMate III (HM3) in 32 (32.7%), and HM II to either HW or HM3 in 13 (13.2%) patients. Postoperatively, right ventricular assist device was required in 16% (8-32). Overall, 20% (8-40) of patients experienced a stroke, while HW patients had a significantly higher stroke incidence than HM3 patients (HW: 21% (8-47) vs. HM3: 5% (1-24), P < .01). Overall 30-day mortality was 10% (6-17), while HW had a significantly worse 30-day mortality than HM3 (HW: 13% (7-24) vs. HM3: 5% (1-24), P = .03). Following device exchange from a different CF-LVAD model, HM3 is associated with lower stroke and higher survival when compared to HW.

Aims Optimal blood pressure (BP) control is imperative to reduce complications, especially strokes, in continuous flow ventricular assist device (VAD) patients. Doppler BP has been shown to be an accurate and reliable non‐invasive BP measurement method in HeartMate II and HVAD patients. We examined whether Doppler BP is also accurate in patients with the HeartMate 3 VAD. Methods and results In a prospective, longitudinal cohort of HeartMate 3 patients, arterial line BP and simultaneously measured Doppler opening pressure were obtained. Correlation and agreement between Doppler opening pressure and arterial line mean arterial pressure (MAP) versus systolic blood pressure (SBP) were analysed, as well as the effect of pulse pressure on the accuracy of Doppler opening pressure. A total of 589 pairs of simultaneous Doppler opening pressure and arterial line pressure readings were obtained in 43 patients. Doppler opening pressure had good correlation with intra‐arterial MAP (r = 0.754) and more closely approximated MAP than SBP (mean error 2.0 vs. −8.6 mmHg). Pulse pressure did not have a clinically significant impact on the accuracy of the Doppler BP method. These results in HeartMate 3 patients are very similar to previous results in HeartMate II and HVAD patients. Conclusions Doppler BP method should be the default non‐invasive BP measurement method in continuous flow VAD patients including patients implanted with the HeartMate 3.

We experienced a rare case of intraoperative type A aortic dissection during HeartMate II (Abbott, Chicago, IL) implantation and subsequently performed emergent total aortic arch replacement. Periodic follow-up computed tomography confirmed that the residual false lumen after the aortic repair had gradually thrombosed over time regardless of sufficient antithrombotic therapy. We analyzed the chronologic changes in the false lumen morphology, showing transient enlargement of the aortic diameter 1 year postoperatively and then a reduction at 3 years postoperatively. We report on the fate of residual false lumen after aortic repair under continuous-flow left ventricular assist device circulation.

OptiVol (Medtronic PLC, Minneapolis, MN) is a diagnostic feature of some cardiac implantable electronic devices (CIEDs) based on changes in thoracic impedance (TI) over time. Changes in TI can predict heart failure (HF) hospitalizations and mortality in HF populations. However, the utility of this feature is unknown in patients with a left ventricular assist device (LVAD). To determine if OptiVol and TI correlate with clinical HF events in a population of LVAD patients, hospitalization outcomes were collected retrospectively from the electronic health records at a single academic medical center in 80 LVAD patients with an OptiVol-capable CIED. Demographics, medical history, and available clinical data were reviewed and reported. The primary outcomes of interest were TI and OptiVol trends before and after hospitalization, and association of trends before and after these events was evaluated. Most patients had a HeartMate II LVAD and most CIEDs were defibrillators, and 23 (29%) had at least one HF hospitalization during the study period. HF hospitalizations were preceded by signs of volume overload in Optivol (60%) and TI (78%) with recovery of these measures post hospitalization in 33% and 25% of patients, respectively. Monitoring of TI and OptiVol may be one effective component of HF management in LVAD patients as part of a comprehensive program.

Early generation left ventricular assist devices (LVAD) for treatment of refractory heart failure attempted to mimic the pulsatility of a native heart and were bulky and less durable due to valves within the inflow and outflow pathways. The next disruption came with the introduction of continuous flow pumps characterized by a low-pulse pressure circulation. Since the mechanism of action did not involve displacement of blood, these pumps were much smaller and less noisy in part due to fewer moving parts. Such devices include the HeartMate II axial-flow pathway pump which is implanted thoraco-abdominally and the HVAD, a centrifugal-flow pathway pump which is smaller and is implanted entirely within the thoracic cavity and uses a combination of hydrodynamic and magnetic levitation of the internal rotor. These pumps improved survival compared with the early generation LVADs and in a trial, the HVAD demonstrated non-inferiority compared with the HeartMate II but with an increase in ischemic and hemorrhagic strokes. The HeartMate 3 LVAD is an intrapericardial centrifugal-flow pathway pump with a full magnetically levitated, frictionless rotor with a fixed intrinsic pulse. In a randomized trial, the HeartMate 3 "hybrid" pump was associated with near-elimination of pump thrombosis, a reduction in strokes of any type or severity and lower mucosal bleeding rates. Despite improvements in hemocompatibility, right heart failure and infections contribute to significant morbidity, and devices designed to be internally contained with a wireless power source and physiological flow characteristics are still required despite great strides in the field.

Short‐to‐shield (STS) is a potential complication for left ventricular assist device (LVAD) patients supported by the HeartMate II (HMII) pump. This phenomenon occurs when a damaged internal wire within the driveline makes contact with the surrounding sheath, resulting in insufficient power delivery to the motor when connected to a grounded power base unit (PBU). An ungrounded cable can be used to negate these effects, but the long‐term safety of this treatment strategy is unknown. In this case series, we present our institutional experience treating 17 STS patients with an ungrounded cable. In total, we present 4922 patient‐days (13.4 patient‐years) of ungrounded cable support after primary STS treatment. There were no deaths or complications related to STS. These data suggest that the long‐term use of an ungrounded cable is a reasonable treatment option for patients who cannot or do not wish to undergo pump exchange or splice repair., Patients that experience short‐to‐shield can be safely managed with an ungrounded cable long‐term with careful monitoring.

Left ventricular assist devices are routinely used to treat patients with advanced heart failure as a bridge to transplant or a destination therapy. However, non-physiological shear stress generated by left ventricular assist devices damages blood cells. The continued development of novel left ventricular assist devices is essential to improve the left ventricular assist device therapy for heart failure patients. The CH-VAD is a new maglev centrifugal left ventricular assist device. In this study, the CH-VAD pump was numerically analyzed and compared with the HVAD and HeartMate II pumps under two clinically relevant conditions (flow: 4.5 L/min, pressure head: normal ~80 and hypertension ~120 mmHg). The velocity and shear stress fields, washout, and hemolysis index of the three pumps were assessed with computational fluid dynamics analysis. Under the same condition, the CH-VAD hemolysis index was two times lower than the HVAD and HeartMate II pumps; the CH-VAD had the least percentage volume with shear stress larger than 100 Pa (i.e. normal condition: 0.4% vs HVAD 1.0%, and HeartMate II 2.9%). Under the normal condition, more than 98% was washed out of the three pumps within 0.4 s. The washout times were slightly shorter under the hypertension condition for the three pumps. No regions inside the CH-VAD or HVAD had extremely long residential time, while areas near the straightener of the HeartMate II pump had long residential time (>4 s) indicating elevated risks of thrombosis. The computational fluid dynamics results suggested that the CH-VAD pump has a better hemolytic biocompatibility than the HVAD and HeartMate II pumps under the normal and hypertension conditions.

We observed different temporal patterns of HeartMate II left ventricular assist device (LVAD) thrombosis regarding clinical manifestations and lactate dehydrogenase (LDH) trends. We propose nomenclature for classification of LVAD thrombosis and compare patient characteristics and outcomes in each pattern of LVAD thrombosis. We reviewed electronic medical records of 362 consecutive HeartMate II devices implanted at Cleveland Clinic from October 2008 to July 2014. We categorized clinical courses of confirmed device thrombosis based on clinical manifestations and LDH patterns. Patients' characteristics, clinical variables, and outcomes were collected for comparison. From a total of 19 confirmed device thromboses, we categorized the patterns of thrombosis into three distinctive types; abrupt thrombosis (Type 1), subacute thrombosis (Type 2), and asymptomatic hemolysis (Type 3). Abrupt thrombosis (Type 1) tended to be the most morbid clinical course with acute-onset thrombosis at 56.5 (interquartile range: 44-71) days, all New York Heart Association functional class III or IV at presentation. Death and need for surgical intervention were not different in each pattern. Asymptomatic hemolysis had unique comorbidities of preexisting cardiac thrombi and preoperative bacteremia. Confirmed LVAD thrombosis has different patterns of clinical presentation and each pattern of thrombosis has unique characteristics and clinical manifestations.

Mechanical unloading with left ventricular assist device (LVAD) support can lead to clinically meaningful reversal of stress-related compensatory mechanisms. However, true assessment of left ventricular ejection fraction (LVEF) is not possible, whereas the left ventricle is unloaded by LVAD therapy making identification of patients with myocardial recovery even more challenging. We introduce our new protocol, the "reverse ramp test" for HeartWare HVAD, HeartMate II, and HeartMate 3. The reverse ramp is transthoracic echo (TTE) and right heart catheterization (RHC)-based protocol with LVAD turn down steps to minimal support allowing for a more accurate assessment of myocardial function.

BACKGROUND Device exchange to a newer generation left ventricular assist device (LVAD) offers the opportunity to benefit from improved adverse events profiles. We present the three year results of a patient cohort undergoing VAD upgrades to a new generation device focusing on outcomes and adverse events. METHODS We present the first series of patients who underwent LVAD upgrade to HeartMate 3. All operations were performed less invasively. Follow-up time was three years after LVAD exchange. RESULTS Overall four HeartMate II and two HVAD patients underwent LVAD upgrade. In five cases severe infection of the VAD led to device exchange (83%, 5/6). Three year survival after LVAD exchange was 100% (6/6). In the follow-up examinations one patient showed a single syncope and several low flow alarms (1/6). The remaining five patients showed no technical malfunctions of the LVAD or hemodynamic adverse events (5/6). Four out of five patients whose devices had to be changed due to an infection suffered a local re-infection (4/5), which, however, did not require any further surgical intervention. Four patients were successfully transplanted and two patients were still on device support at three years after LVAD exchange. CONCLUSIONS Three-year outcomes and adverse events after LVAD exchange to HeartMate 3 show excellent results. The superior hemocompatibility in terms of pump thrombosis makes the HM3 a favored choice in case of LVAD exchange due previous pump thrombosis. However, in cases of exchange due to device infection the risk of reinfection remains high.

Several risk scores and classifications are available to predict peri- and post-operative mortality of patients with end stage heart failure receiving Left Ventricular Assist Device (LVAD) therapy. Sarcopenia has been suggested as a sensitive predictor for post-operative mortality. We evaluated whether the psoas muscle area can predict mortality in patients undergoing LVAD implantation. The indexed psoas mean area (PMAi) was obtained by measuring the psoas muscle area at the superior endplate of the third lumbar vertebra correlated to body surface area of 106 adult patients undergoing LVAD implantation (Medtronic HVAD n = 41, Abbott HeartMate II n = 4, Abbott HeartMate 3 n = 61, mean age 65, IQR 12, 90.6% male, INTERMACS Level 1 24.5%, ischemic CMP 64.2%). Patients were divided in two groups: high/moderate and low muscle mass. The primary endpoint was 30-day mortality, assessed using a multivariate Cox proportional hazards model. Baseline characteristics did not differ between patients with high or moderate and low PMAi. Estimated survival calculated a significant higher 30-day mortality in patients with low PMAi (p = 0.04). Multivariable Cox proportional hazards regression analysis indicated low PMAi, history of previous cardiac surgery and levels of bilirubin as independent predictors of mortality in the first 30 days. In conclusion, indexed psoas muscle area predicts mortality after LVAD implantation and can be used as an additional tool for risk stratification.

The driveline’s durability is crucial for optimal long-term support with a left-ventricular assist device (LVAD). The incidence of percutaneous driveline fracture after HeartMate II LVAD implantation is low. For the first time, we describe a patient with an already repaired driveline and a massive constriction and twisting of the driveline in the area of the repair site. This dramatic finding necessitates a renewed exchange of the external part of the driveline by the manufacturer. Due to the increasing number of patients with elongated LVAD support, the stability of the driveline and possible repairs including the replacement of the driveline are becoming more and more important. Our case report describes a possible serious late complication after replacement of the driveline, shows possible risks for this development, and describes the necessity of a prophylactic X-ray examination of repaired drivelines to detect such complications as early as possible.

This study examined left-ventricular assist device (LVAD) patients with pre-LVAD ventricular arrhythmias (VAs) to determine the rate of recurrent post-LVAD VAs and the impact of pre-LVAD atrial fibrillation (AF) on recurrent post-LVAD VAs. Medical records of 195 consecutive LVAD patients were reviewed. Descriptive statistics were generated and Cox proportional hazard models were used to assess the association of clinical variables with the time to recurrent VA. Forty-seven percent of 195 CHF patients who received LVAD-manifested significant VAs prior to LVAD implant (82% Heartmate II, 14% HVAD, 4% other; median follow-up = 17 months), 41% of whom manifested recurrent post-LVAD VAs. Pre-LVAD AF was associated with recurrent VAs (hazard ratio = 3.73; 95% CI 1.33, 10.48; p = 0.012). Recurrent VAs were associated with increased mortality (hazard ratio = 3.06; 95% CI 1.17, 7.98; p = 0.023). A history of AF is prevalent in over half of LVAD patients with recurrent VAs and is associated with time to recurrence of VA.

Strokes remain a leading cause of morbidity and mortality in patients with ventricular assist devices (VADs). Varying study populations, event definitions, and reporting methods make direct comparison of neurologic event risk across clinical trials and registries challenging. We aim to highlight important differences among major VAD studies and standardize rates of neurologic events to facilitate a comprehensive and objective comparison. We systematically identified and analyzed key clinical trials and registries evaluating the HeartMate II (HMII), HeartMate 3 (HM3), and HVAD devices. Reported neurologic events were nonexclusively categorized into ischemic stroke, hemorrhagic stroke, disabling stroke, fatal stroke, and other neurologic events per the studies' definitions. Event rates were standardized to events per patient-year (EPPY) and freedom from event formats. Seven key clinical trials and registries were included in our analysis. There is significant variation and overlap in neurologic event rates for the three VAD platforms across clinical trials (all neurologic events [EPPY]: HM3 0.17-0.21; HMII 0.19-0.26; HVAD 0.16-0.28). None performs consistently better for all types of neurologic events. Furthermore, stroke rates among VAD trials correlated with baseline stroke risk factors including ischemic etiology, history of atrial fibrillation, and history of prior stroke.

The effect of blood group on heart transplant list mortality in the era of continuous flow left ventricular assist devices (VADs) is unknown. We sought to examine mortality from the United Network for Organ Sharing (UNOS) database, with focus on mortality among VAD versus non-VAD recipients according to blood group. The UNOS database from 2007 to 2015 was evaluated to compare the rates of waitlist mortality or delisting for clinical worsening at 1-year postlisting among various blood types based on the presence or absence of durable continuous VAD. Patients with pulsatile VAD, temporary VAD, or with incomplete data were excluded. A total of 16,803 patients met the inclusion criteria. Of these, 2,663 had a HeartMate II or HeartWare VAD implanted before listing or by 365th day of listing. The rate of adverse events on the waitlist, irrespective of VAD, was highest among group O patients (odds ratio [OR] 1.54, p < 0.001). The use of VAD was associated with significant relative risk reduction (OR 0.43, p < 0.001) in waitlist adverse events among all patients, with relative risk reduction that overall did not vary by blood group. Among VAD recipients, waitlist adverse events were similar across all blood types. Among listed patients, there is a significantly higher adverse event rate in group O patients compared with others, irrespective of VAD use. With implantation of continuous flow HeartMate II or HeartWare VAD, all blood groups experience similar relative benefit and similar rates of adverse events. All patients, but particularly those with blood group O, eligible for VAD as a bridge to transplant should be considered for VAD placement.

Background Despite technological advancements, pump durability and pump-related complications continue to affect and adversely impact the lives of patients with end-stage heart failure on left ventricular assist device (LVAD) support. In an attempt to avoid recurrent LVAD-related complications, there may be circumstances where it is clinically advantageous to exchange a patient's device from HeartMate II to HeartWare HVAD. However, there is a paucity of data that describes the safety and feasibility of such an approach. Objective We present the largest single-center series of HeartMate II (HMII) to HeartWare (HVAD) device exchanges. Methods A retrospective review of 11 patients who underwent HMII to HVAD exchange from 2012 to 2017 was conducted to evaluate patient characteristics, incidence of postoperative complications, and survival. Results Eleven male patients (mean age 55 ± 14.4 years) underwent HMII to HVAD device exchange. One patient expired on postoperative day 7 secondary to sepsis. One patient was lost-to-follow-up after 23 months. An additional three patients died at 5, 7, and 24 months. Mean follow-up after device exchange was 1555 ± 311 days for the remaining six patients. None of the 11 study patients underwent LVAD explant, further device exchange, or heart transplant. Conclusion Exchange of an HMII LVAD to an HVAD can be performed safely with acceptable perioperative morbidity and mortality.

Left ventricular assist devices (LVADs) increase survival of patients with heart failure. However, long-term LVAD usage can result in aortic insufficiency (AI), thereby compromising LVAD efficiency. Transcatheter aortic valve replacement (TAVR) is an alternative for patients with high risk for surgical valve replacement. We present three cases that developed moderate to severe AI while on HeartMate II (Abbott Laboratories, Chicago, IL) LVAD support; hence, TAVR procedure was performed. Patients A and B (74 year old and 38 year old) developed severe AI and patient C (67 year old) developed moderate AI with cardiogenic shock, after 368, 1,288, and 342 days on LVAD support, respectively. Their aortic valve annulus sizes were 24.2, 24.6, and 23.3 mm, respectively. Oversized Edwards SAPIEN 3 valves (Edwards, Lifesciences, Irvine, CA) were implanted via a transfemoral approach. The patients were hemodynamically stable after the procedure with mild AI in patient A and no AI in patients B and C. Patients were all discharged to home. Follow-up in patients A and C have resulted in long-term (> 2 years) survival and patient B died 616 days after the procedure due to unrelated complications. Transcatheter aortic valve replacement may be an alternative way to manage AI in LVAD patients. Larger studies are needed to evaluate the long-term efficacy of this approach.

Background Electromagnetic interference between left ventricular assist devices (LVAD) and the telemetry wand of implantable cardioverter‐defibrillators (ICD) with impairment of ICD interrogation has previously been described in HVAD and HeartMate II devices. This is the first study showing the potential influence of the LVAD model HeartMate 3 (with the unique feature of fully magnetically levitated rotor with consistent wide blood‐flow gaps) on functional interrogation of different ICD models. Methods and Results Among 51 patients treated with a HeartMate 3 LVAD, 34 patients (66.7%) already had an ICD implanted prior to LVAD therapy. In this cohort, impairment of ICD interrogation was observed in five patients (14.7%) with five different device models. In patients with Biotronik ICD, stretching of the ipsilateral arm to increase the distance between both devices >10 cm was sufficient in one patients, whereas surgical contralateral repositioning was necessary in two patients; in one further patient no action could be taken, as he died early from embolic stroke. In the only patient with a MicroPort ICD, this issue was resolved by using a wireless telemetry. The distances between both devices showed no statistical significant correlation with an impaired interrogation, neither in the overall collective nor within the groups with the same manufacturer. Conclusions In patients with impaired ICD interrogation caused by electromagnetic interference between a HeartMate 3 LVAD and the ICD, the actions mentioned above have to be taken, to resolve this technical issue. Especially, a sufficient distance of at least 10 cm between both devices was crucial for avoiding this problem.

Patient: Male, 66 Final Diagnosis: Ischemic cardiomyopathy Symptoms: Angina pectoris • dyspnoea Medication: — Clinical Procedure: — Specialty: Surgery Objective: Unusual clinical course Background: We report a 66-year-old patient who received implantation of HeartMate II LVAD (St. Jude Medical, Minneapolis, MN, USA) as destination therapy 10 years ago. Case Report: Preoperatively, the patient developed acute heart failure due to transmural myocardial infarction requiring catecholamine therapy and intra-aortic balloon pump. Echocardiography revealed a left ventricular ejection fraction of 15%. We saw an indication for left ventricular assist device (LVAD) implantation. The intraoperative course was uncomplicated. The operation time was 153 minutes and the cardiopulmonary bypass time was 69 minutes. The procedure was performed in normothermia, and no further combined procedures were necessary. Only one re-hospitalization, due to driveline infection, was required. Once a month, the patient visited our heart failure outpatient clinic for laboratory control, echocardiographic examination, and device measurement. There was always a normal LVAD function. During the 10 years of follow-up, the patient did not have any other complications. Conclusions: Patients with a strict indication for LVAD and fewer risk factors can show a relatively uncomplicated postoperative course. Our case report demonstrates the opportunity to care for a patient for years using LVAD. Modern LVADs are reliable cardiac support systems as destination therapy from the long-term perspective. Careful patient selection, timely decision on LVAD implantation, and structured patient care are critical.

Left ventricular assist device is an established therapeutic option for the patient with end-stage heart failure. Recently, durable continuous-flow devices have replaced earlier generation of pulsatile devices and their desirable features are accelerating the utilization of these devices. However, their powerful performance could sometimes induce unfavorable complications such as sucking, especially in not so dilated left ventricle. Special maneuvers such as cannula position and lower pump speed may be reasonable for patients with non-dilated left ventricular, however, those managements have not been established yet to date. Right ventricular failure is also another concern in these devices. We experienced a patient who got a HeartMate II in spade-shaped, non-dilated left ventricle concomitant with right ventricular dysfunction, and successfully managed her.

Background The main purpose of this article is to investigate the impact of previous sternotomy (PS) on the outcome of three different left ventricular assist devices (LVAD). Methods Between June 2007 and February 2018, a total of 121 patients received HeartMate II (60.3%), HeartWare (12.4%), or HeartMate III (27.3%), with or without previous sternotomy (PS and non-PS groups, respectively). Propensity matching resulted in 44 patient pairs. The primary end point was overall survival at 30 days, 1 year, 2, and 5 years, postoperatively. Secondary end points were adverse events. Results The overall cumulative survival rates for the two study groups were significantly different (77, 63, 54, and 38% for non-PS group vs 64, 39, 27, and 24% for PS group, p = 0.036). In the PS group, there was a higher need for intraoperative implantation of short-term right ventricular assist device (22.7 vs 6.8%, p = 0.034) and a higher incidence of hepatic dysfunction (20.5 vs 4.5%, p = 0.025) and acute kidney dysfunction (40.9 vs 20.5%, p = 0.032). Conclusion PS is a reliable predictor of mortality and morbidity after LVAD implantation.

Background: There is a lack of robust data evaluating outcomes of enoxaparin “bridge” therapy in left ventricular assist device (LVAD) patients. Methods: We performed a retrospective study of HeartMate II (HM II) and HeartWare HVAD recipients that received therapeutic enoxaparin as “bridge” therapy to describe bleeding and thrombotic events and compare outcomes between devices. The primary endpoint was the incidence of bleeding within 30 days of “bridge” episode. Major bleeding was defined by INTERMACS criteria. Results: We evaluated 257 “bridge” episodes in 54 patients, 35 with a HM II device and 19 with an HVAD device that underwent 176 and 81 bridging episodes, respectively. The median INR prior to “bridge” was lower in the HM II group compared to the HVAD group (1.5 vs 1.7, P < .01), however, there was no difference in the median duration of “bridge” therapy (7 vs 7 days, P = .42). There were a total of 30 (12%) bleeding episodes, with the majority in the HM II group vs HVAD (26 [15%] vs 4 [5%], P = .02). We observed 3 (1%) thromboembolic events in 2 (4%) patients with an HVAD device. On multivariate analysis, the presence of a HM II device was associated with a 4-fold increased risk of bleeding. Conclusion: We found the use of enoxaparin “bridge” therapy to be associated with a higher incidence of bleeding in patients with a HM II device compared with an HVAD device. Assessment of device- and patient-specific factors should be evaluated to minimize bleeding events.

An outflow graft twist of a left ventricular assist device (LVAD) remains a challenging clinical diagnosis and may even be misdiagnosed for other outflow obstructions. We present a case of a patient with two LVAD exchanges due to suspected outflow graft twisting in both clinical scenarios. As new LVADs continue to be designed and upgraded, clinicians must have a high index of suspicion for this rare complication.

With mounting time on continuous-flow left ventricular assist device (CF-LVAD) support, patients occasionally sustain damage to the device driveline. Outcomes associated with external and internal driveline damage and repair are currently not well documented. We sought to evaluate the outcomes of driveline damage and its repair. Electronic search was performed to identify all relevant studies published over the past 20 years. Fifteen studies were selected for analysis comprising of 55 patients with CF-LVAD dysfunction due to driveline damage. Demographic and perioperative variables along with outcomes including survival rates were extracted and pooled for the systematic review. Most patients (53/55) were supported on HeartMate II LVAD (Abbott Laboratories, Abbott Park, IL). Internal damage was more commonly reported than external damage [69.1% (38/55) vs. 30.9% (17/55), P = .01]. Median time to driveline damage was 1.9 years [IQR 1.0, 2.5]. Most patients presented with a CF-LVAD alarm [94.5% (52/55)] and patients with internal driveline damage had a significantly higher rate of alarm activation compared to that observed for those with external damage [38/38 (100%) vs. 14/17 (82.4%), P = .04]. Patients with internal driveline dysfunction were more likely to experience component wear compared to those with external driveline dysfunction [10/38 (26.3%) vs. 0/17 (0%), P = .05]; 14.5% of patients (8/55) underwent external repair of the driveline, 5.5% (3/55) were treated with rescue tape, and 5.5% (3/55) were placed on an ungrounded cable, indicating a short-to-shield event had occurred. A total of 49.1% of patients (27/55) underwent CF-LVAD exchange, 5.5% (3/55) were weaned off the CF-LVAD to explant, and 5.5% (3/55) underwent emergent heart transplantation. The median length of hospital stay was 12 days [IQR 7, 12] and 30-day mortality rate was 14.5% (8/55). Driveline damage was more commonly reported at an internal location and despite being a well-recognized complication, mortality still appears high.

Background De novo aortic insufficiency (AI) is a common adverse event following continuous flow left ventricular assist device (LVAD) placement and is associated with morbidity and mortality. This study aims to compare the development of de novo AI between HeartMate 3 and HeartMate II LVAD recipients. Methods A retrospective review was conducted of clinical characteristics and serial echocardiograms (1 month, 6 months, and 1 year post-implantation) of HeartMate 3 patients implanted between November 2014 and March 2019, and of HeartMate II patients implanted between April 2004 and December 2015 at Columbia University Irving Medical Center. Patients (n=122) were excluded from analysis for a history of aortic valve surgery, concomitant aortic valve surgery with LVAD implant, or more than trace preoperative AI left untreated. De novo AI was defined as development of more than mild AI following LVAD implant. Results There were 121 HeartMate 3 patients and 270 HeartMate II patients included in the study. After accounting for competing risks of death and transplantation, there was no significant difference in the development of de novo AI by 1 year post-implantation between HeartMate II and HeartMate 3 patients (p = 0.68). There was no significant difference in severity between HeartMate II and HeartMate 3 among those patients who developed AI up to 1 year post-implantation. Conclusions Development of de novo AI is comparable between HeartMate 3 and HeartMate II patients. There is no significant difference in severity of AI between HM II and HM 3 patients.

Our institution employs gallium-67 single-photon emission computed tomography low-dose CT (Ga-SPECT-CT) to determine the presence and extent of left ventricular assist device (LVAD) infections. We present a retrospective single-center study of 41 LVAD recipients who underwent Ga-SPECT-CT from January 2011 to June 2018 to determine whether Ga-SPECT-CT led to changes in antimicrobial therapy, LVAD revision or exchange, or application for 1A exception. The average age was 56.6 years, predominantly male (80.5%) and diabetic (68.3%), divided between ischemic (48.8%) and nonischemic (51.2%) cardiomyopathy. The majority had HeartMate II devices (82.9%). Device-related infections were classified as possible (12.2%), probable (36.6%), proven (36.6%), or rejected (14.6%). Sensitivity was 68.6% and specificity was 100%. Most VAD-specific infections were percutaneous deep driveline infections (DRIs) (34.1%), and VAD-related infections were primarily bloodstream infections (31.7%). Staphylococcus aureus was the major pathogen isolated. Gallium-67 single-photon emission computed tomography low-dose CT resulted in changes in management in more than half (53.7%) of patients: starting (24.4%) or stopping (17.1%) antimicrobial therapy, LVAD revision (22.0%) or exchange (12.2%), and the application for 1A exception for transplant listing (17.1%). We conclude that Ga-SPECT-CT is an effective modality for determining the presence and extent of LVAD DRIs, and contributed to a change in management in more than half of cases.

Introduction: Prior studies have shown that females have worse 3-month survival post-LVAD. Currently used prognostic scores including the Heartmate II Risk Score (HMRS), were developed in >75% male cohorts, and may not account for the increased residual risk in females. Hypothesis: A sex-specific risk score will predict post-LVAD mortality in females, and perform better than HMRS. Methods: Adult CF-LVAD patients from the ISHLT Mechanically Assisted Circulatory Support (IMACS) registry (Implant years: Jan 2013 - Sep 2017, age: 56 ± 13 yrs, 21% female, 36% centrifugal pumps) were randomly divided into derivation (DC, n=9113, 21% female) and validation cohorts (VC, n=6074, 21% female). Primary outcome of interest was 3-month mortality. IMACS risk score (IMACS-RS) was developed in the DC, from pre-operative candidate predictors selected using Akaike Information Criterion, or significant sex*variable interaction. Results: There were 1,466 deaths (9.7%) within 3 months after implant. In the DC, age, cardiogenic shock at implant, Body Mass Index, Blood Urea Nitrogen, bilirubin, hemoglobin, albumin, platelet count, LV End Diastolic Diameter, Tricuspid Regurgitation, dialysis and major infection pre-implant were retained as significant predictors of 3-month mortality. There was a significant ischemic HF*sex and platelet count*sex interaction. For each quartile increase in IMACS-RS, females had 93% increased odds (p Conclusions: A sex-specific risk score provides excellent risk prediction in LVAD patients. Future prognostic studies in advanced HF should present sex-specific secondary outcomes.

Hemodynamic support with continuous-flow left ventricular assist device (CF-LVAD) therapy has proven a reliable treatment for advanced heart failure. Although modern LVADs are highly durable, device failure and infection can be resolved with surgical exchange of pump components. In this study, we investigated the incidence and outcomes of LVAD exchange with the HeartMate II and HeartWare HVAD. Data were obtained from 677 patients who underwent CF-LVAD implantation between 2005 and 2016. Patients who underwent a device exchanged were included. The primary outcomes were length of hospital stay and mortality. Of the 677 patients included in this study, 72 (10.6%) required LVAD exchange. Thirty-day and 1-year mortality rates were comparable to primary LVAD implantation: 4.3% vs. 3.49%, p = 0.727 and 20.3% vs. 20.7%, p = 0.989, respectively. Thirty-one patients (4.5%) underwent exchange with ongoing infection. Kaplan-Meier analysis indicated significant differences in survival between groups based on indication for exchange. Patients who underwent exchange after more than 150 days of active infection suffered worse postexchange survival than those who underwent exchanged earlier (P = 0.007). While exchange was required only in 10.6% of patients undergoing LVAD implantation, our results show device exchange may be executed safely and effectively, with long-term outcomes similar to primary LVAD implantation. The indication for device exchange impacts postexchange outcomes, and those exchanged with LVAD infection tend to fare worse than those exchanged for device malfunction or thrombus. Patients who are exchanged with active infection have better postoperative survival if the exchange is performed expeditiously after medical management has failed.

Background Implantation of left-ventricular assist systems (LVASs) has become the standard of care for advanced heart failure (HF). The absence of pulsatility in previous devices contributes to vascular and endothelial dysfunction related to atherosclerotic or vascular complications. We hypothesized that the artificial pulsatility provided by the HeartMate 3 (HM3) (Abbott, Chicago, IL) LVAS would exert a favourable effect on the vasculature. Methods In 32 patients implanted with HM3 (5 female patients, mean age 55 ± 13.6 years), the reactive hyperemia index (RHI) and peripheral augmentation index (AI), markers of endothelial function and arterial stiffness, were measured with an EndoPAT2000 before and in the third and sixth month after implantation. RHI and AI data from 30 HeartMate II (HM II) (Abbott) recipients in the third and sixth month after implantation, from 15 patients with advanced HF without LVASs and from 13 healthy volunteers were also analyzed. Results In HM3 recipients, the mean RHI significantly decreased at 3 and 6 months after implantation. The RHI was substantially lower at baseline than that of healthy or the HF reference group. Increasing AI values, indicating worsening arterial stiffness, were also observed. Similar trends were observed in HM II recipients between the third and sixth months but with higher absolute values of RHI and AI. Conclusions We detected impaired vascular function in HM3 patients and provided additional evidence on the negative effect of low pulsatility on vascular function after LVAS implantation. The results suggest that the artificial pulsatility of the HM3 does not avert the progression of endothelial dysfunction.

Biocompatibility of ventricular assist devices (VADs) has been steadily improving, yet the rate of neurological events remains unacceptably high. Recent speculation for elevated stroke rates centers on ingestion of thrombi originating upstream of the pump, such as in the ventricle or left atrial appendage. These thrombi may be ejected by the VAD or become deposited within the blood flow pathway, presenting serious complications to the patient. This study was performed to visualize and quantify the degree of disruption, adherence, and disintegration of thrombi that are ingested by the three most implanted VADs: the HeartMate II, HeartMate 3, and HVAD. Clot analogs of varying microstructure compositions (red, white) and sizes (0.5, 1, 2 cm3 ) were synthesized in vitro based on clinical explant data. These were introduced individually into an in vitro flow loop with a transparent replica of the HMII, HM3, and HVAD operated at nominal steady flow (2.3-4.0 L/min). High-speed videography (up to 10 000 fps) revealed the ingestion, disruption, ejection, and adherence of thrombus fragments. Thromboemboli of varying compositions and sizes were observed mechanically attaching to components in all 3 VAD models. In some instances, ingested thrombi physically obstructed portions of the blood flow path; 18% (3 of 17 total) of red thrombi adhered to the inflow straightener of the transparent HMII. In the HVAD model, fewer than 4% of clots were adherent or trapped within the pump, irrespective of microstructure or initial volume. In comparison, 100% (4 of 4 total) of 1-cm3 white (fibrin) clots became lodged within the transparent HM3 while, in contrast, less than 5% of macerated red clots (3 of 63 total) of the same volume were adherent inside the pump. A significant proportion of ingested thrombi were macerated into infinitesimal fragments; 84% and 74% of 2-cm3 red thrombi in the HVAD and HM3 models, respectively, were found to have disintegrated upon ingestion. However, large emboli were also discharged from both centrifugal VADs; these fragments, ranging from 0.01 to 0.29 cm3 regardless of microstructure and original volume, may be capable of occluding an intracranial vessel. Therefore, ingested thrombus may explain, in part, elevated stroke rates in contemporary blood pumps in the absence of adherent pump thrombosis.

Device infection and stroke are still frequently reported as complications of left ventricular assist devices, and strict management of anticoagulation therapy is sometimes difficult at the time of infection status. We report the case of a 55-year-old man with a HeartMate II (Abbott, Inc., Abbott Park, IL, USA) as a bridge to cardiac transplantation. The patient measured his prothrombin time-international normalized ratio (PT-INR) by himself using a point-of-care device at home and reported the result promptly on a social networking service (SNS). Physicians instructed the patient on how to adjust his dose of warfarin based on the result and suggested the next time of measurement on the SNS. Until cardiac transplantation, we adjusted the dose of warfarin 106 times using the SNS because of unexpected PT-INR fluctuations caused by antibiotics. The time in the therapeutic range was maintained at 83.2% without complications, including major bleeding, stroke, or pump replacement; however, there was transient intra-pump thrombosis triggered by severe dehydration due to hyperthyroidism.

Computational fluid dynamics has become a dynamic tool in the development of ventricular assist devices (VADs) and as a predictor of thrombosis within these pumps. The genesis of thrombi could be in loco, due to deposition within the VAD, or upstream such as the left atrial appendage or inside the left ventricle. To calibrate our group's computational model, a retrospective analysis of 29 explanted HeartMate II (HMII) VADs due to suspected pump thrombosis (PT) from the University of Michigan was conducted. Thrombi in these pumps were characterized by their frequency, composition, severity, and physical distribution in five regions of the blood flow pathway. The outlet bearing/stator region had the highest frequency of deposition (≈72%), and the preponderance of thrombi appeared white and unlaminated in their microstructure. Conversely, 41.3% of VADs showed thrombus on the fore bearing of the HMII, and these formations tended to be red and laminated, indicating they formed in layers over time. Furthermore, the majority of clots observed in the fore bearing and outlet bearing/stator regions were partially occlusive in nature. Fourteen VADs presented PT in multiple regions and analysis of the data showed a statistically significant correlation (p < 0.01) between deposition in the fore bearing and subsequent thrombosis in the outlet bearing/stator; however, no other regions exhibited statistically significant correlations. This gives credence to the hypothesis that thrombi do not occur independently in multiple regions of the blood flow pathway in the HMII but may propagate downstream.

Left ventricular assist devices (LVADs) are being increasingly implanted given the increasing prevalence of patients with advanced heart failure stages. However, they are not exempt from device malfunctions. A PubMed search for the key words (left ventricular assist device malfunction) (ventricular assist system malfunction) was performed. We identified 28 publications in the US Food and Drug Administration (FDA) website database that addressed LVAD malfunction. Twenty-nine FDA recalls were identified regarding LVAD malfunctions: 17 regarding HeartWare ventricular assist device, six for HeartMate II, three for HeartMate 3, and three for total artificial heart. Mechanisms involved in LVAD malfunction include battery malfunction, loose driveline connector, malfunction of the system controller, loose power supply connector ports, malfunction of the driveline splice kit, problems with the percutaneous lead connection, disconnection of the bend relief and outflow graft and outflow graft occlusion among others. Multiple mechanisms could be linked to LVAD malfunction. However, multiple device modifications have been developed over the past decade to avoid recurrent malfunctions. Constant improvements and research in biotechnology are needed to prevent these complications. It remains to be seen if newer generation devices will lead to improved patient outcomes over the long term.

HeartMate II left ventricular assist device controllers provide data including pulsatility index, reflecting the relationship between pump function and hemodynamics. We propose that a higher pulsatility index at hospital discharge following implant may be associated with less vascular congestion and improved clinical outcomes. A retrospective analysis of 40 patients (age 59.2 ± 10.3 years) supported with the HeartMate II devices was conducted. Data revealed moderate Pearson correlations between pulsatility index at discharge and right atrial pressure, pulmonary artery systolic pressure, pulmonary artery diastolic pressure, mean pulmonary arterial pressure, and pulmonary capillary wedge pressure, respectively, post-surgery (median of 377 days), demonstrating a stronger relationship when analyzed for the EPC controller (n = 28) only (r = −.57, p

Aims To investigate the prevalence of electromagnetic interference (EMI) between left ventricular assist devices (LVADs) and implantable cardioverter-defibrillators (ICDs)/pacemakers (PMs). Methods and results A retrospective single-centre study was conducted, including all patients undergoing HeartMate II (HMII) and HeartMate 3 (HM3) LVAD implantation (n = 106). Electromagnetic interference was determined by the inability to interrogate the ICD/PM. Overall, 85 (mean age 59 ± 8, 79% male) patients had an ICD/PM at the time of LVAD implantation; 46 patients with HMII and 40 patients with HM3. Among the 85 LVAD patients with an ICD’s/PM’s, 11 patients (13%) experienced EMI; 6 patients (15%) with an HMII and 5 patients (11%) with an HM3 (P = 0.59). Electromagnetic interference from the HMII LVADs was only present in patients with a St Jude/Abbott device; 6 of the 23 St Jude/Abbott devices. However, in the HM3 patients, EMI was mainly present in patients with Biotronik devices: 4 of the 18 with only one (1/25) patient with a Medtronic device. While initial interrogation of these devices was not successful, none of the 11 cases experienced pacing inhibition or inappropriate shocks. Conclusion In summary, the prevalence of EMI between ICDs in the older and newer type of LVAD’s remains rather high. While HMII patients experienced EMI with a St Jude/Abbott device (which was already known), HM3 LVAD patients experience EMI mainly with Biotronik devices. Prospective follow-up, preferably in large registries, is warranted to investigate the overall prevalence and impact of EMI in LVAD patients

International normalized ratio (INR) measurements manage risks of bleeding and clotting sequelae in the population with left ventricular assist device (LVAD). Studies suggest that point-of-care (POC) INR does not significantly differ from plasma INR (P-INR) values in other patient populations, although this has not been validated in a multicenter LVAD study. We sought to determine whether POC-INR and P-INR values differ significantly in the LVAD population and reviewed patients with permanent LVAD implantation at seven institutions internationally. Our cohort comprised of 279 paired POC-INR and P-INR checks in patients supported on average 630 ± 598 days postimplant with predominately HeartWare, HeartMate II, and HeartMate III devices. The population averaged 57.9 years of age, and there were 86.7% male. We found no statistically significant difference between POC-INR and P-INR values. International normalized ratio accuracy correlated weakly with the time between INR measurements (p < 0.001). When the time difference was less than 4 hours, the difference between INR pairs was significantly lower than measurements greater than 8 hours (p = 0.006). There was no statistically significant difference when comparing paired INR values and time after implant to INR check (p = 0.43), age (p = 0.12), known coagulopathy (p = 0.12), bleeding history (p = 0.22), or thrombosis history (p = 0.34). This is the first large multicenter international study comparing POC-INR and P-INR measurements in patients with LVAD and found no statistically significant difference between either methods, particularly when measured within less than 4 hours of each other.

Left ventricular assist device (LVAD) thrombosis is a devastating complication that occurs in about 10% of patients despite anticoagulation and antiplatelet treatment. How the thrombus initiates and propagates is unknown. We pathologically and immunohistochemically examined 28 thrombi removed from 17 HeartMate II (HMII) left ventricular assist devices (LVADs). Two groups of thrombi were found, those formed in the inlet/outlet and those on the rotor. The four thrombi found at the inlet (three inlet conduit and one inlet tube) and outlet (three at outlet elbow and one outlet graft) appeared similar and were composed of a loose meshwork of fibrin(ogen), von Willebrand factor, leukocytes, and aggregated platelets. The majority of the thrombi (20/28), however, were located on the rotor: nine at the inlet bearing, five on the rotor vanes, and six at the outlet bearing. Laminated thrombi formed around the inlet bearing in rings, an area of blood recirculation. The inner rings of the thrombus had fibrin and von Willebrand factor. Aggregated platelets were found in the outer thrombi rings, but limited evidence of platelets within the laminated thrombi was noted. The presence of distinct rings suggests development of the clot over time. The increased platelets in the outer rings of the inlet bearing thrombi would support further investigation into their role in thrombus growth. Initiating events require further investigation, but the fibrin-rich structure of HMII thrombi suggests that alternative anticoagulation strategies are needed to prevent thrombosis in our LVAD patients.

Background: The MOMENTUM 3 trial compares the centrifugal HeartMate 3 (HM3) with the axial HeartMate II (HMII) continuous-flow left ventricular assist system in patients with advanced heart failure, irrespective of the intended goal of therapy. The trial’s 2-year clinical outcome (n=366) demonstrated superiority of the HM3 for the primary end point (survival free of a disabling stroke or reoperation to replace or remove a malfunctioning pump). This analysis evaluates health resource use and cost implications of the observed differences between the 2 devices while patients were enrolled in the trial. Methods: We analyzed all hospitalizations and their associated costs occurring after discharge from the implant hospitalization until censoring (study withdrawal, heart transplantation, and pump exchange with a nonstudy device or death). Each adjudicated episode of hospital-based care was used to calculate costs (device-attributable and non–device-attributable event costs), estimated by using trial data and payer administrative claims databases. Cost savings stratified by subgroups (study outcome [transplant, death, or ongoing on device], intended goal of therapy, type of insurance, or sex) were also assessed. Results: In 366 randomly assigned patients, 361 comprised the as-treated group (189 in the HM3 group and 172 in the HMII group), of whom 337 (177 in the HM3 group and 160 in the HMII group) were successfully discharged following implantation. The HM3 arm experienced fewer total hospitalizations per patient-year (HM3: 2.1±0.2 versus HMII: 2.7±0.2; P =0.015) and 8.3 fewer hospital days per patient-year on average (HM3: 17.1 days versus HMII: 25.5 days; P =0.003). These differences were driven by patients hospitalized for suspected pump thrombosis (HM3: 0.6% versus HMII: 12.5%; P P =0.002). Controlled for time spent in the study (average cumulative cost per patient-year), postdischarge HM3 arm costs were 51% lower than with the HMII (HM3: $37 685±4251 versus HMII: $76 599±11 889, P Conclusions: In this 2-year outcome economic analysis of the MOMENTUM 3 trial, the HM3 demonstrated a reduction in rehospitalizations, hospital days spent during rehospitalizations, and a significant cost savings following discharge in comparison with the HMII left ventricular assist system, irrespective of the intended goal of therapy. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02224755.

We hypothesized that the externalizing direction of the driveline (the driveline angle) at the percutaneous exit site would influence the occurrence of driveline infection after left ventricular assist device implantation. From August 2013 to May 2017, 71 patients were implanted with a HeartMate II device in our center. The driveline angle was measured on anteroposterior radiography just after implantation. Risk factors for driveline infection were analyzed by uni- and multivariate analyses. Driveline infection developed in 10 (14%) patients during follow-up. Overall actual freedoms from driveline infection at 6, 12, and 24 months were 96%, 88%, and 86%, respectively. Overall number of driveline infection events per patient-year was 0.16. Receiver operating characteristic analysis determined the cut-off point of the driveline angle as 41°. The 6-, 12-, and 24-month actuarial freedoms from driveline infection in those with driveline angle more than 42° (84%, 74%, and 74%, respectively) were significantly lower than in those with driveline angle less than 41° (97%, 94%, and 90%, respectively; p

The HeartMate II™ Left Ventricular Assist System has been implanted in more than 26,000 patients and is the most widely used and studied durable mechanical circulatory support device in patients with advanced heart failure. The device is intended for use as bridge to transplantation in candidates at risk of imminent death from non-reversible left ventricular (LV) failure and for destination therapy for use in patients with end-stage LV failure. This chapter describes each component of the system, the mechanisms of the pump itself, the physiology of blood flow under different pump speeds and pressure gradients, and ways to prevent pump thrombus. In addition, the functions and interface of the System Controller and System Monitor are detailed, including the settings displayed on the monitor and the type of alarms provided, as well as their appearance on the interface. The chapter closes with a discussion of how a ramped-speed study using echocardiography and hemodynamic assessment can identify the pump speed that provides the desired level of cardiac support for each patient.

Development of pediatric ventricular assist devices (VADs) has significantly lagged behind that of adult devices. This frustrating reality is reflected by the fact that the Berlin Heart EXCOR VAD is currently the only approved pediatric-specific device in the USA. An alternative option is an off-label use of adult continuous-flow VADs, such as HeartMate II (HMII), which inevitably causes patient-device size mismatch in small children. We sought to conduct in vitro hemocompatibility testing in a pediatric flow condition, with a specific aim to provide benchmark values for future pediatric device development. Given the aforementioned fact that both pulsatile and continuous-flow devices are being used in the pediatric population, we opted to test both types of devices in the present study. The EXCOR and HMII blood pumps were tested using bovine blood under constant hemodynamic conditions (flow rate, Q = 2.5 ± 0.25L/min; differential pressure across the pump, ΔP = 68 ± 5mm Hg). Hemolysis was measured by Harboe assay. There was a steady increase in plasma free hemoglobin during in vitro testing, with a statistically significant difference between 5 and 360 min for both EXCOR (P < 0.0001) and HMII (P < 0.001). However, the degree of an increase in plasma free hemoglobin was more significant with HMII (P < 0.001). Normalized index of hemolysis for EXCOR and HMII were 0.003 ± 0.0026g/100 L and 0.085 ± 0.0119g/100 L, respectively. There was also a steady increase in platelet activation detected by CAPP2A antibody using flow cytometry, with a statistically significant difference between 5 and 360 min for both devices (P < 0.05). The degree of an increase in platelet activation was similar between the two devices (P = 0.218). High molecular weight von Willebrand factor (HMW vWF) multimer degradation measured by immunoblotting was evident for both devices, however, it was more pronounced with the EXCOR. EXCOR blood samples from all three time points (120, 240, and 360 min) were significantly different from the baseline (5 min), whereas only 360 min samples had a significant difference from the baseline with the HMII. In conclusion, we have observed similarities and differences in hemocompatibility profiles between the EXCOR and HMII, both of which are commonly used in the pediatric population. We anticipate the benchmark values in the present study will facilitate future pediatric VAD development.

As the cases of heart failure continue to rise, more ventricular assist devices are likely to be implanted. Providers in a variety of care environments are more likely to see patients with ventricular assist devices because they are living longer; therefore, it is necessary for providers to understand the unique care and complications related to these devices, such as thrombosis, stroke, bleeding, right-sided heart failure, ventricular dysrhythmias, and infection. The current literature regarding the complications and management of patients with these devices was reviewed and summarized, with a focus on HeartWare (HeartWare International Inc, Framingham, MA) and HeartMate II (Thoratec Corp, Pleasanton, CA).