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Aims: This study aimed to compare the changes in the left ventricle (LV) and right ventricle (RV) geometry and performance after the implantation of HeartMate II (HMII) and HeartMate 3 (HM3). In addition, we investigated whether the echocardiographic parameters LV sphericity index (LVSI) and the novel pressure‐dimension index (PDI) can predict post‐operative right ventricular failure (RVF). Methods and results: Between 2012 and 2020, 46 patients [HMII (n = 22) and HM3 (n = 24)] met the study's criteria and had echocardiography tests pre‐operatively, 6 and 12 months post‐operatively. The LVSI and PDI were calculated together with the standard LV and RV echocardiographic parameters. The mean follow‐up was 24 ± 7 months. In both groups, the LV end‐diastolic diameter (LVEDD) significantly decreased 12 months post‐operatively compared with the pre‐operative values (HMII: 6.4 ± 1.4 cm vs. 5.7 ± 0.9 cm, P = 0.040; HM3: 6.7 ± 1.3 cm vs. 5.5 ± 0.9 cm, P < 0.01, respectively). RV function 12 months post‐operatively was better in the HM3 group than in the HMII group, as indicated by a significantly higher RV fractional area change (RVFAC) in the HM3 group than in the HMII group 12 months post‐operatively (35 ± 12% vs. 26 ± 16%, P = 0.039), significantly higher tricuspid annular plane systolic excursion (TAPSE) in the HM3 group 12 months post‐operatively compared with the HMII group (13.9 ± 1.9 mm vs. 12.0 ± 2.1 mm, P = 0.002), and the tissue Doppler estimated tricuspid annular systolic velocity (TASV) was also significantly higher in the HM3 group 12 months post‐operatively compared with the HMII group (11.5 ± 2.7 mm/s vs. 9.9 ± 1.5 mm/s, P = 0.020). The LVSI value was significantly higher 12 months post‐operatively in the HMII group than in the HM3 group (1.2 ± 0.4 vs. 0.8 ± 0.2, P = 0.001, respectively), indicating worse geometric changes. The PDI decreased 12 months post‐operatively in the HM3‐group compared with the baseline (3.4 ± 1.4 mmHg/cm2 vs. 2.0 ± 0.8 mmHg/cm2, P < 0.001). In the univariate and multivariate analyses, only the pre‐operative PDI was a predictor of post‐operative RVF [odds ratio: 3.84 (95% CI: 1.53–18.16, P = 0.022)]. The area under the curve for pre‐operative PDI was 0.912. The 2 year survival was significantly better in the HM3 group (log‐rank, P = 0.042). Conclusions: The design of HM3 offered better geometrical preservation of the LV and enabled normal PDI values, leading to improved RV function, as indicated by better RVFAC, TAPSE, and TASV values. The use of pre‐operative PDI as an additional tool for established risk scores might offer a better pre‐operative predictor of RVF. [ABSTRACT FROM AUTHOR]

Abstract Aims This study aimed to compare the changes in the left ventricle (LV) and right ventricle (RV) geometry and performance after the implantation of HeartMate II (HMII) and HeartMate 3 (HM3). In addition, we investigated whether the echocardiographic parameters LV sphericity index (LVSI) and the novel pressure‐dimension index (PDI) can predict post‐operative right ventricular failure (RVF). Methods and results Between 2012 and 2020, 46 patients [HMII (n = 22) and HM3 (n = 24)] met the study's criteria and had echocardiography tests pre‐operatively, 6 and 12 months post‐operatively. The LVSI and PDI were calculated together with the standard LV and RV echocardiographic parameters. The mean follow‐up was 24 ± 7 months. In both groups, the LV end‐diastolic diameter (LVEDD) significantly decreased 12 months post‐operatively compared with the pre‐operative values (HMII: 6.4 ± 1.4 cm vs. 5.7 ± 0.9 cm, P = 0.040; HM3: 6.7 ± 1.3 cm vs. 5.5 ± 0.9 cm, P

A 47-year-old woman with dilated cardiomyopathy underwent HeartMate II (HM2) implantation as a bridge-to-transplantation. Her postoperative course was good. However, 2.5 years after surgery, the outflow graft was found to be twisted and the graft and pump was exchanged. While HeartMate 3(HM3) twisting of the outflow graft is well documented, such malfunctions in HM2 are almost unknown. Although HM2 has since been discontinued, there are a significant number of patients using HM2 who are awaiting heart transplants or destination therapy. We caution that, even with HM2, the possibility of late-phase twisting requires vigilance. [ABSTRACT FROM AUTHOR]

This article discusses a rare case of a lightning strike causing damage to a left ventricular assist device (LVAD), a device used to manage end-stage heart failure. The patient's LVAD was connected to a house power source when lightning struck, resulting in dysfunction of the device. The article highlights the vulnerability of electrical devices to external factors such as lightning strikes and emphasizes the importance of proper electrical isolation in the patient's home. The case also suggests the use of percutaneous venoarterial ECMO implantation and LVAD exchange in cases of severe electrical damage to the LVAD. The article concludes by emphasizing the need for physicians to remain vigilant and prepared for unexpected challenges in managing LVAD patients. [Extracted from the article]

Background: We evaluated the impact of a standardized driveline care strategy, including a subfascial‐tunneling method and dressing protocol, on the incidence of driveline infection (DLI). Methods: DLI data from all HeartMate II (HMII) and HeartMate 3 (HM3) patients (including exchange devices) were retrospectively collected between 2013 and 2021. The driveline subfascial‐tunneling method was altered in three steps (A: right direct; B: left triple, C: right triple), and the shower protocol was changed in two steps (A: with/without cover, B: with cover). Disinfection was individually tailored after changing the shower protocol. Complications associated with morbidity and mortality were evaluated for each modification. Results: During the study period, 80 devices were implanted (HMII, n = 54; HM3, n = 26). The 8‐year incidence of DLI was 15% (n = 8) in HMII patients and 0% in HM3 patients (p = 0.039). DLI was not associated with hospital mortality. The modified dressing protocol and tunneling method was associated with a significantly better DLI incidence rate in comparison to the previous one: Protocol‐A (n = 17), Protocol‐B (n = 63), 35% vs 3% (p = 0.0009), Method‐A (n = 13), Method‐B (n = 42), Method‐C (n = 25), 46% vs 5% vs 0% (p = 0.0001). The rete of freedom form DLI at 1, 2, and 3 years had also significant difference between groups: Protocol‐A and Protocol‐B, 80%, 54%, 54% vs 96%, 96%, 96%, respectively (p < 0.0001), Method‐A, Method‐B and Method‐C, 76%, 44%, 44%, vs 94%, 94%, 94% vs 100%, 100%, respectively (p < 0.0001). Conclusions: A standardized triple driveline tunneling strategy and waterproof dressing protocol reduced driveline infection in HM3 patients to 0%. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Gastrointestinal bleeding (GIB) is a common adverse event after continuous‐flow left ventricular assist device (CF‐LVAD) implantation. We sought to evaluate patterns of GIB development and related outcomes in CF‐LVAD recipients. An electronic search was performed to identify all articles related to GIB in the setting of CF‐LVAD implantation. A total of 34 studies involving 1087 patients were pooled for analysis. Mean patient age was 60 years (95% CI 57‐64) and 24% (95% CI 21‐28%) were female. The mean time from CF‐LVAD implantation to the first GIB was 54 days (95% CI 24‐84) with 40% (95% CI 34‐45%) of patients having multiple episodes of GIB. Anemia was present in 75% (95% CI 41‐93%) and the most common etiology of bleeding was arteriovenous malformations (36% [95% CI 24‐50%]). The mean duration of follow‐up was 14.6 months (95% CI 6.9‐22.3) during which the all‐cause mortality rate was 21% (95% CI 12‐36%) and the mortality rate from GIB was 4% (95% CI 2‐9%). Thromboembolic events occurred in 32% (95% CI 22‐44%) of patients with an ischemic stroke rate of 16% (95% CI 3‐51%) and a pump thrombosis rate of 8% (95%CI 3‐22%). Heart transplantation was performed in 31% (95% CI 18‐47%) of patients, after which 0% (95% CI 0‐10%) experienced recurrent GIB. GIB is a major source of morbidity among CF‐LVAD recipients. While death due to GIB is rare, cessation of anticoagulation during treatment increases the risk of subsequent thrombotic events. Heart transplant in these patients appears to reliably resolve the risk of future GIB. [ABSTRACT FROM AUTHOR]

Hemolysis is closely related with pump thrombosis and thromboembolic events in patients with continuous flow left ventricular assist devices. We retrospectively investigated the impact of early postoperative heparinization on hemolysis in patients with HeartMate II devices. From April 2013 to August 2017, 83 patients (age 45 ± 12 years; 20 females; body surface area 1.6 ± 0.2 m2) underwent HeartMate II implantation. Postoperative heparinization was started when hemostasis was achieved and continued until full warfarinization. Hemolysis was defined in accordance with the Interagency Registry for Mechanically Assisted Circulatory Support definitions. The average support period was 22 ± 14 months. The 6-, 12-, and 24-month freedoms from hemolysis were 72%, 70%, and 67%, respectively. Pump thrombosis developed in five (6%) patients and four (5%) required pump exchanges. Heparin start time was significantly later in patients with hemolysis (43 ± 23 h after implantation) versus those without (29 ± 14 h after implantation; p = 0.01). Receiver operating characteristic analysis determined the cut-off point of heparin start time as 29 h. The patients were divided into the early group (heparin start time < 29 h; n = 29), and the late group (heparin start time > 29 h; n = 54). The respective 6-, 12-, and 24-month freedoms from hemolysis for the early group (86%, 86%, and 86%, respectively) were significantly higher than those for the late group (49%, 47%, and 44%, respectively; p = 0.002). Being in the late group was an independent risk factor for hemolysis (hazard ratio 4.09). Early postoperative heparinization (within 29 h after implantation) reduces hemolysis in patients with HeartMate II devices. [ABSTRACT FROM AUTHOR]

Background: As of December 31, 2016, in the United States, 22 866 patients received left ventricular assist devices (LVADs) (J Heart Lung Transplant. 2017; 36(10):1080-1086). First responders are generally unfamiliar with LVAD equipment functionality (J Heart Lung Transplant. 2018;37(4):S275). When a patient has an emergency either clinically or with a controller alarm or failure, speaking with ventricle assist device (VAD)-trained personnel is imperative to the prevention of adverse events. Starting February 2017, an LVAD program totaling 181 patients at a large teaching hospital changed their afterhours process to reduce wait time between patient call and talking to VAD-trained personnel to increase patient safety and patient satisfaction. Methods: The Plan-Do-Check-Act quality improvement method was used to evaluate this project from February 2017 to July 2018 by the program's clinical information analyst. An afterhours summary of telephone interactions between VAD program clinicians (VAD coordinators, physician assistants, and nurse practitioner) was used to analyze the use of the "VAD Emergency Line." An annual patient satisfaction survey was completed to analyze patient satisfaction of the VAD Emergency Line. Interventions: Review of the afterhours summary was conducted to determine the use of the VAD Emergency Line. The process of afterhours patient calls was changed so that calls are answered immediately by a 24-hour LVAD-trained medical ambulance service, called VAD Emergency Line. Patient use of the VAD Emergency Line was continuously assessed. In November 2017, it was recognized that only 57% of patient calls used the VAD Emergency Line, and further intervention was needed. In November 2017, patients were provided visual reminders to ensure compliance. Results: Seventeen months after the implementation of the VAD Emergency Line, 92% of patient's afterhours calls were through the VAD Emergency Line. Although there was no statistical significance found, there was clinical significance. Since the implementation of the VAD Emergency Line, patient use of the VAD Emergency Line increased 56% from March 2017 to July 2018. There have been zero adverse safety events. Sixty-one percent of patients strongly agreed to the question "You are able to communicate emergent needs after hours (VAD Emergency Line)? Conclusion: Implementation of the LVAD Emergency Line has improved communication between patients in the outpatient setting. This increased patient safety by allowing patients to speak to LVAD-trained first responders and VAD coordinator personnel immediately without ever being put on hold. This communication process can be applied to other clinical programs. [ABSTRACT FROM AUTHOR]

Objective: No clinical study compares outcomes of left ventricular assist device (LVAD) implantation in patients with end-stage heart failure secondary to ischemic cardiomyopathy (ICM) and non-ICM (NICM). The purpose of this study is to analyze the outcome of LVAD therapy in these 2 cohorts of patients. Materials and Methods: Forty-four patients had HeartMate II LVAD implantation between September 2012 and August 2014. Charts were retrospectively reviewed and data accumulated were statistically analyzed. Results: A total of 23 (52%) patients were presented with ICM. Average age in ICM was 63.7 ± 6.8 years as opposed to 53.9 ± 16.3 in NICM (P = 0.017). About 78% of ICM and 67% of NICM group were male (P = 0.388). 43.5% of ICM had undergone previous cardiac operation versus 9.5% of NICM (P = 0.012). Implant strategy was bridge to transplant in 78% of ICM and 67% of NICM (P = NS) and destination therapy in 22% of ICM and 33% of NICM (P = NS). A thirty-day mortality rate was 17% in the ICM and 0% in the NICM (P = 0.06). One-year mortality was 39% for ICM and 19% for NICM (P = 0.14). On multivariate analysis, ICM emerged as an independent predictor of mortality (odds ratio: 3.19). Variables such as serum creatinine, inotropic or vasopressor requirement, intraaortic balloon pump use, or complex operations involving aortic or tricuspid valves at the time of LVAD placement did not impact mortality. Conclusions: This report, based on a nonmatched cohort of 44 patients, demonstrates that in an era of selective criteria for LVAD implantation, ICM emerges as an independent predictor of mortality. These patients tend to be older and are more likely to be undergoing reoperative sternotomy. These results should form the basis for a larger scale investigation of LVAD implantation in ICM patients.

Heart failure is considered a worldwide pandemic affecting 26 million people globally. Patients who are unfit or waiting for cardiac transplantation may benefit from alternate mechanical support therapies using ventricular assist devices. It is not uncommon for radiologists, especially those working in institutions with a high volume of cardiac transplantations, to be presented with radiographs containing these devices. The role of the radiologist is not only to accurately identify these devices, but also to evaluate for any complications.

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

No standardized treatment algorithm exists for the management of continuous‐flow left ventricular assist device (CF‐LVAD)‐specific infections. The aim of this systematic review and meta‐analysis was to compare the outcomes of CF‐LVAD‐specific infections as managed by device exchange to other treatment modalities not involving device exchange. Electronic search was performed to identify all studies in the English literature relating to the management of CF‐LVAD‐specific infections. All identified articles were systematically assessed for selection criteria. Thirteen studies with 158 cases of CF‐LVAD‐specific infection were pooled for analysis. Overall, 18/158 (11.4%) patients underwent CF‐LVAD exchange, and 140/158 (88.6%) patients were treated with non‐exchange modalities. The proportion of patients with isolated driveline infections or pump or pocket infections did not differ significantly between the groups. During a mean follow‐up of 290 days, there were no significant differences in the overall mortality [exchange 17.6% (4.3–50.6) vs. non‐exchange 23.3% (15.8–32.9), P = 0.67] and infection recurrence rates [exchange 26.7% (8.7–58.0) vs. non‐exchange 38.6% (15.4–68.5), P = 0.56]. In the setting of CF‐LVAD‐specific infections, device exchange does not appear to confer an advantage in the overall mortality and infection recurrence as compared to non‐exchange modalities. [ABSTRACT FROM AUTHOR]

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 < 0.02). The numbers of driveline infection events per patient-year were 0.16 in patients with driveline angle more than 42°, and 0.04 in patients with driveline angle less than 41°. Multivariate analysis demonstrated that driveline angle more than 42° was an independent risk factor for driveline infection (hazard ratio 4.71). Driveline angle more than 42° is an independent risk factor for driveline infection in patients with HeartMate II. Externalization of the driveline toward the horizontal direction is important to prevent driveline infection with HeartMate II. [ABSTRACT FROM AUTHOR]

Heart failure is considered a worldwide pandemic affecting 26 million people globally. Patients who are unfit or waiting for cardiac transplantation may benefit from alternate mechanical support therapies using ventricular assist devices. It is not uncommon for radiologists, especially those working in institutions with a high volume of cardiac transplantations, to be presented with radiographs containing these devices. The role of the radiologist is not only to accurately identify these devices, but also to evaluate for any complications. [ABSTRACT FROM AUTHOR]

Left ventricular assist devices (LVADs) have become the standard therapy for patients with end-stage heart failure, and the use of LVADs for long-term support has grown exponentially over the past decade. As the number of LVAD implantations has increased, surgeons have faced more challenging cases, such as those in which the patient has previously undergone a sternotomy. The HeartMate II is one of the most widely implanted LVADs. The standard procedure for HeartMate II implantation is median sternotomy and sewing the outflow graft to the ascending aorta. However, in patients with sternal comorbidities, it can be advantageous to use a less invasive approach that avoids this procedure. We describe the case of a 64-year-old man with a history of end-stage ischemic cardiomyopathy who had previously undergone a median sternotomy and a coronary artery bypass grafting operation and had patent grafts. He required a HeartMate II LVAD (destination therapy), which was implanted via a left subcostal incision; the pump was placed subdiaphragmatically, and the outflow graft was sewed to the descending aorta to avoid a complicated redo cardiac operation via median sternotomy and to minimize the risk of injuring the patent bypass grafts. The patient survived for more than 500 days postoperatively. This approach is feasible and could be a safer method for implanting a HeartMate II device in patients with serious comorbidities that preclude the use of the traditional implantation techniques. [ABSTRACT FROM AUTHOR]

Thromboembolic complication rates of 20%–30% were initially a major limitation to the widespread use of left ventricular assist devices. The success of the HeartMate (Thoratec, Corp., Pleasanton, CA, USA) device has been partly due to the reduced incidence of thromboembolic events, although anticoagulation regime has been recommended for this mechanical circulatory support. We here present a case with the placement of HeartMate II in a patient, noncompliant to medical therapy where device worked for 8 months without any anticoagulant or antiplatelet therapy.

No abstract available. Article truncated at 150 words. Introduction: Left ventricular assist device (VAD) therapy is an increasingly utilized treatment as a bridge to heart transplantation or as long-term destination therapy. Recent reports show there is a 22% - 32% incidence of VAD-associated infections with staphylococci and nosocomial gram-negative bacilli being the most common causative organisms (1,2). These organisms are often found in intensive care units, where they have the highest proportion of resistance, thus exposing already critically ill patients to the possibility of resistant organism VAD-associated infections (3). Mortality rates exceed 60% when sepsis develops in a patient with a continuous flow left VAD and infection is the number one cause of death in those awaiting cardiac transplantation (4,5). With continued left VAD use clinicians will likely see multidrug-resistant (MDR) or even pandrug-resistant organism VAD-associated infections. Clinicians need to be prepared to manage such an intimidating entity. Case Report: We report a case of a 25 year-old ...

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. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Improved outcomes over the past decade have increased confidence of physicians and patients in extended duration of left ventricular assist device (LVAD) support. This single-centre cohort study reports 5-year outcomes with the HeartMate II (HMII) LVAD. METHODS: We describe a cohort of 89 patients who received a HMII LVAD between February 2004 and December 2010. The causes of death and adverse events were assessed by examination of medical records. A total of 202.74 patient-years were analysed. RESULTS: After 5 years, of the 89 patients, 15 patients remained on device therapy, 39 patients died, 28 patients underwent heart transplantation and 7 patients underwent explantation of the HMII for recovery. One year after the HMII implantation, there was a survival of 71% in the study cohort. In the following years, the survival rate was 65% in the 2nd year, 63% in the 3rd year, 56% in the 4th year and 54% after 5 years of LVAD support. Ten LVAD exchanges were performed in 8 (11%) patients. Currently (March 2017), 12 patients still remain on their original device. The longest ongoing patient on the HMII has been supported for over 11 years (4097 days). The most common adverse events were bleeding (68%; 1.5837 events per patient-year) and LVAD infection [49%; 1.0666 events per patient-year]. Seven cases of pump thrombosis were described (8%; 0.1131 events per patient-year). CONCLUSIONS: This is the first single-cohort study to describe a 5-year survival of HMII patients on extended duration of support. A 5-year survival of 54% was observed in this single-centre cohort. [ABSTRACT FROM AUTHOR]

Background Primary outcomes analysis of the Multicenter Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3 (MOMENTUM 3) trial short-term cohort demonstrated a higher survival rate free of debilitating stroke and reoperation to replace/remove the device (primary end-point) in patients receiving the HeartMate 3 (HM3) compared with the HeartMate (HMII). In this study we sought to evaluate the individual and interactive effects of pre-specified patient subgroups (age, sex, race, therapeutic intent [bridge to transplant/bridge to candidacy/destination therapy] and severity of illness) on primary end-point outcomes in MOMENTUM 3 patients implanted with HM3 and HMII devices. Methods Cox proportional hazard models were used to analyze patients enrolled in the “as-treated cohort” ( n = 289) of the MOMENTUM 3 trial to: (1) determine interaction of various subgroups on primary end-point outcomes; and (2) identify independent variables associated with primary end-point success. Results Baseline characteristics were well balanced among HM3 ( n = 151) and HMII ( n = 138) cohorts. No significant interaction between the sub-groups on primary end-point outcomes was observed. Cox multivariable modeling identified age (≤65 years vs >65 years, hazard ratio 0.42 [95% confidence interval 0.22 to 0.78], p = 0.006]) and pump type (HM3 vs HMII, hazard ratio 0.53 [95% confidence interval 0.30 to 0.96], p = 0.034) to be independent predictors of primary outcomes success. After adjusting for age, no significant impact of sex, race, therapeutic intent and INTERMACS profiles on primary outcomes were observed. Conclusions This analysis of MOMENTUM 3 suggests that younger age (≤65 years) at implant and pump choice are associated with a greater likelihood of primary end-point success. These findings further suggest that characterization of therapeutic intent into discrete bridge-to-transplant and destination therapy categories offers no clear clinical advantage, and should ideally be abandoned. [ABSTRACT FROM AUTHOR]

Background Hemolysis, assessed by elevated serum lactate dehydrogenase (LDH), is strongly associated with HeartMate II pump thrombosis (PT). However, it is unknown whether early intervention for elevated LDH circumvents the risk of serious PT requiring pump exchange. We sought to evaluate the relationship between elevated LDH and clinical outcomes, the effectiveness of early medical intervention, and risk factors for elevated LDH. Methods We studied 268 patients in the prospective, multicenter PREVENT study who had 2 or more LDH measurements at ≥30 days post-implant. Elevated LDH was defined as LDH ≥2.5× upper limit of normal (ULN) for 2 consecutive measurements. Results Fourteen percent of patients had elevated LDH. Stroke-free survival at 6 months was lower in patients with elevated LDH vs patients with normal LDH (83 ± 6% vs 93 ± 2%, p = 0.035). Elevated LDH resolved without intervention in 19% of patients, with intensified medical therapy in 43% and required surgical intervention in 38%. For patients receiving only medical therapy, survival was 94 ± 6% at 6 months post-treatment. In this subgroup, resolution of symptoms with intensified medical therapy was sustained in 15 of 16 patients, with PT occurring in 1 patient at 171 days after initial treatment for elevated LDH (202 days post-implant). Early medical intervention at moderately elevated LDH (2.5× to 3.2× ULN), as compared with higher levels (>3.2× ULN), led to more sustained resolution of symptoms without subsequent PT or need for surgical intervention (91% vs 26% at 6 months post-treatment, p = 0.002). Conclusions Early medical intervention can successfully resolve moderate LDH elevations (2.5× to 3.2× ULN) with a low incidence of death or PT at 6 months post-treatment. [ABSTRACT FROM AUTHOR]

Introduction: Left-ventricular assist devices (LVAD) are becoming a common therapy for end-stage heart failure. These devices are not tested for pressurization in a hyperbaric chamber by the manufacturer. In this article, we present an approach to modify the power supply in order to safely treat a patient with an LVAD. Materials and methods: Our patient had a HeartMate IITM LVAD and presented for hyperbaric oxygen treatments for severe radiation cystitis. In order to modify this patient's equipment to be compliant with NFPA6 safety standards we made several modifications. In brief, this included eliminating the usage of lithium-ion batteries, modifying the cord to be compatible with Fink chamber outlets, and enclosing the power module in a nitrogen purge. We then used a mock circulatory system to test our modifications and make sure the LVAD continued to have appropriate flow rates. We then conducted training for staff and developed a disaster plan should the LVAD fail at any point. Results: Once we felt comfortable with the modifications and had a plan developed should any problems arise, we then proceeded to treat our patient in the hyperbaric chamber. He successfully underwent 44 hyperbaric treatments for radiation cystitis without complications. Conclusion: This case is the second reported patient in the literature with an LVAD that was successfully treated in a multiplace hyperbaric chamber. As LVADs become increasingly popular to manage heart failure, more patients with these devices will present for hyperbaric treatments. With a few modifications, an LVAD patient can be safely and successfully treated in a hyperbaric chamber. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Left ventricular assist device (LVAD) exchange is becoming a standard surgical procedure. The exchange procedure is an opportunity to upgrade patients to a new generation pump that offers advanced reduction of adverse events or longer battery hours. METHODS: We performed an analysis of 6 consecutive patients who underwent LVAD exchange to HeartMate 3 either from a HeartWare or HeartMate (HM) II device. Minimally invasive operations were performed through a lateral thoracotomy. Follow-up time was 6 months after LVAD exchange. RESULTS: We present 4 patients with the HMII and 2 patients with the HeartWare ventricular assist device (HVAD) who underwent LVAD exchange to HM III. The average age was 57.5 years. At the time of the LVAD exchange, all patients were classified as Interagency Registry for Mechanically Assisted Circulatory Support level 3. In 5 cases, LVAD infection led to LVAD exchange (83%, 5/6). The remaining patient underwent LVAD exchange due to pump thrombosis (16%, 1/6). The 6-month survival rate after LVAD exchange was 100% (6/6). None of the patients was postoperatively supported by extracorporeal membrane oxygenation. No patient experienced postoperative relevant bleeding. One patient suffered minor cerebral bleeding (16.6%, 1/6). At the 6-month follow-up examination, 1 patient reported a single syncope and several low-flow alarms (1/6). The remaining 5 patients showed no adverse events or technical malfunctions of the VAD (5/6). CONCLUSIONS: LVAD exchanges from HM II as well from HVAD to HM 3 are proven to be technically feasible. Due to the advantages and technical improvements of the new-generation pumps, this procedure is an excellent opportunity to give patients access to a superior generation of assist device. [ABSTRACT FROM AUTHOR]

Although the survival rate for left ventricular assist device (LVAD) therapy has improved, device-related complications are an unpredictable threat to the patient's quality of life. We focused on driveline infection, and aimed to determine whether specific features of drivelines affect the frequency of infection. We enrolled patients who underwent LVAD implantation and were followed-up at our institute between 2007 and 2015. We counted the occurrences of driveline infection requiring any antibiotic therapy over a 2-year study period. Furthermore, we experimentally measured and compared the outer diameters and stiffness of three devices. Of all, 72 patients received an LVAD during the enrollment period. LVADs were HeartMate II ( n = 32), EVAHEART ( n = 22), and DuraHeart ( n = 18). The outer diameters and stiffness were measured in five of each device. HeartMate II group had the highest driveline infection-free rate among all three devices during the study period ( p = 0.042). The driveline of the HeartMate II LVAD had a significantly smaller outer diameter and lower stiffness than that of the other two devices ( p < 0.05 for both). In conclusion, device-specific driveline features may affect the development of driveline infection during LVAD therapy. [ABSTRACT FROM AUTHOR]

Background Recommended structured clinical practices including implant technique, anti-coagulation strategy, and pump speed management (PREVENT [ PREVEN tion of HeartMate II Pump T hrombosis Through Clinical Management] recommendations) were developed to address risk of early (<3 months) pump thrombosis (PT) risk with HeartMate II (HMII; St. Jude Medical, Inc. [Thoratec Corporation], Pleasanton, CA). We prospectively assessed the HMII PT rate in the current era when participating centers adhered to the PREVENT recommendations. Methods PREVENT was a prospective, multi-center, single-arm, non-randomized study of 300 patients implanted with HMII at 24 participating sites. Confirmed PT (any suspected PT confirmed visually and/or adjudicated by an independent assessor) was evaluated at 3 months (primary end-point) and at 6 months after implantation. Results The population included 83% men (age 57 years ± 13), 78% destination therapy, and 83% Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profile 1–3. Primary end-point analysis showed a confirmed PT of 2.9% at 3 months and 4.8% at 6 months. Adherence to key recommendations included 78% to surgical recommendations, 95% to heparin bridging, and 79% to pump speeds ≥9,000 RPMs (92% >8,600 RPMs). Full adherence to implant techniques, heparin bridging, and pump speeds ≥9,000 RPMs resulted in a significantly lower risk of PT (1.9% vs 8.9%; p < 0.01) and lower composite risk of suspected thrombosis, hemolysis, and ischemic stroke (5.7% vs 17.7%; p < 0.01) at 6 months. Conclusions Adoption of all components of a structured surgical implant technique and clinical management strategy (PREVENT recommendations) is associated with low rates of confirmed PT. [ABSTRACT FROM AUTHOR]

Background Early right-sided heart failure (RHF) after left ventricular assist device (LVAD) implantation is associated with increased mortality, but little is known about patients who develop late RHF (LRHF). We evaluated the incidence, risk factors, and clinical impact of LRHF in patients supported by axial-flow LVADs. Methods Data were analyzed from 537 patients enrolled in the HeartMate II (HM II; Thoratec/St. Jude) destination therapy clinical trial. LRHF was defined as the development of clinical RHF accompanied by the need for inotropic support occurring more than 30 days after discharge from the index LVAD implant hospitalization. Clinical variables, quality of life, rehospitalizations, and survival were compared between patients with and without LRHF. Results LRHF developed in 41 patients (8%), with a median time to LRHF of 480 days. A higher preoperative blood urea nitrogen and increased central venous pressure–to–pulmonary capillary wedge pressure ratio were independent predictors of LRHF. The Michigan and HMII RHF risk scores were both associated with an increased likelihood of LRHF ( p < 0.05). Patients with LRHF had worse quality of life according to the Kansas City Cardiomyopathy Questionnaire (61 ± 26 vs 70 ± 21; p < 0.05), poorer functional capacity by 6-minute walk distance (275 ± 189 m vs 312 ± 216 m; p < 0.05), and more rehospitalizations (6 vs 3; p < 0.001). LRHF was associated with decreased survival ( p < 0.001). Conclusions LRHF is an important complication in patients with LVADs and is associated with worse quality of life, reduced functional capacity, more frequent hospitalizations, and worse survival compared with those without LRHF. [ABSTRACT FROM AUTHOR]

Described herein is a 61-year-old man who underwent replacement of a left ventricular assist device that had been in place for 54 months. A small mass was attached to the margin of the excised metallic inflow cannula of the left ventricular assist device. Histologically, the mass was found to contain myocardium. [ABSTRACT FROM AUTHOR]

Left ventricular assist devices (LVADs) have become a standard therapy for patients with severe heart failure. As low blood trauma in LVADs is important for a good clinical outcome, the assessment of the fluid loads inside the pump is critical. More specifically, the flow features on the surfaces where the interaction between blood and artificial material happens is of great importance. Therefore, experimental data for the near-wall flows in an axial rotary blood pump were collected and directly compared to computational fluid dynamic results. For this, the flow fields based on unsteady Reynolds-averaged Navier-Stokes simulations-computational fluid dynamics (URANS-CFD) of an axial rotary blood pump were calculated and compared with experimental flow data at one typical state of operation in an enlarged model of the pump. The focus was set on the assessment of wall shear stresses (WSS) at the housing wall and rotor gap region by means of the wall-particle image velocimetry technique, and the visualization of near-wall flow structures on the inner pump surfaces by a paint erosion method. Additionally, maximum WSS and tip leakage volume flows were measured for 13 different states of operation. Good agreement between CFD and experimental data was found, which includes the location, magnitude, and direction of the maximum and minimum WSS and the presence of recirculation zones on the pump stators. The maximum WSS increased linearly with pressure head. They occurred at the upstream third of the impeller blades and exceeded the critical values with respect to hemolysis. Regions of very high shear stresses and recirculation zones could be identified and were in good agreement with simulations. URANS-CFD, which is often used for pump performance and blood damage prediction, seems to be, therefore, a valid tool for the assessment of flow fields in axial rotary blood pumps. The magnitude of maximum WSS could be confirmed and were in the order of several hundred Pascal. [ABSTRACT FROM AUTHOR]

Background: Early postoperative ventricular tachyarrhythmia (PoVT) after left ventricular assist device (LVAD) implantation are common and associated with higher mortality-rates. At present, there is no data on initiation of these PoVT and the role of alterations in cardiac hemodynamics.Case Presentation: A LVAD was implanted in a patient with end-stage heart failure due to a ischemic cardiomyopathy. Alterations in cardiac rhythm and hemodynamics preceding PoVT-episodes during the first five postoperative days were examined by using continuous recordings of cardiac rhythm and various hemodynamic parameters. All PoVT (N=120) were monomorphic, most often preceded by short-long-short-sequences or regular SR and initiated by ventricular runs. Prior to PoVT, mean arterial pressure decreased; heart rate and ST-segments deviations increased.Conclusions: PoVT are caused by different underlying electrophysiological mechanisms. Yet, they are all monomorphic and preceded by hemodynamic deterioration due to myocardial ischemia. [ABSTRACT FROM AUTHOR]

Background Data from 3 institutions revealed an abrupt increase in HeartMate II (Thoratec) pump thrombosis starting in 2011, associated with 48% mortality at 6 months without transplantation or pump exchange. We sought to discover if the increase occurred nationwide in Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) data, and if so (1) determine if accelerated risk continued, (2) identify predictors, (3) investigate institutional variability, and (4) assess mortality after pump thrombosis. Methods From April 2008 to June 2014, 11,123 HeartMate II devices were implanted at 146 institutions. Machine learning, non-parametric Random Forests for Survival was used to explore risk-adjusted thrombosis based on 87 pre-implant and implant variables, including implant date. Results A total of 995 pumps thrombosed, with risk peaking within weeks of implant. The risk-adjusted increase in pump thrombosis began in 2010, reached a maximum in 2012, and then plateaued at a level that was 3.3-times higher than pre-2010. Pump exchange, younger age, and larger body mass index were important predictors, and institutional variability was largely explained by implant date, patient profile, and duration of support. The probability of death within 3 months after pump thrombosis was 24%. Conclusions Accelerated risk of HeartMate II thrombosis was confirmed by Interagency Registry for Mechanically Assisted Circulatory Support data, with risk subsequently leveling at a risk-adjusted rate higher than observed pre-2010. This elevated thrombosis risk emphasizes the need for improved mechanical circulatory support systems and post-market surveillance of adverse events. Clinicians cognizant of these new data should incorporate them into their and their patients’ expectations and understanding of risks relative to those of transplantation and continued medical therapy. [ABSTRACT FROM AUTHOR]

Background Pump thrombosis in durable continuous-flow pumps is a barrier to long-term mechanical circulatory support. Earlier Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) data identified an increasing risk of pump thrombosis in recent years with the HeartMate II (HMII) left ventricular assist device. The current analysis examines pump thrombosis in the patient cohort extended through June 2014. Methods The INTERMACS identified 9,808 adult patients from 144 institutions receiving a primary HMII implant between April 2008 and June 30, 2014. Pump thrombosis was identified at time of explant, transplant or death. Risk factors for pump thrombosis were examined by multivariable analysis in the hazard function domain. The association between pump thrombosis and implant year was modeled in the hazard domain. Results Parametric hazard modeling of thrombosis by year of implant identified an increasing risk of pump thrombosis from 2009 through 2013, followed by a decrease in the risk during the first half of 2014 , which was most apparent during the first 3 months post-implant. Risk factors for pump thrombosis included younger age ( p < 0.001), higher body mass index ( p = 0.02), history of non-compliance ( p = 0.004), severe right heart failure ( p = 0.02), later date of implant ( p < 0.0001), and elevated lactate dehydrogenase during the first month post-implant ( p < 0.0001). Subsequent pump thrombosis was more likely if the initial pump exchange indication was pump thrombosis ( p < 0.0001). Conclusions The small, but progressive increase in the incidence of pump thrombosis observed between 2010 and 2013 with the HMII pump had reversed somewhat in the first half of 2014. Identification of marked elevation of lactate dehydrogenase during the first month offers an opportunity for early intervention strategies. [ABSTRACT FROM AUTHOR]

Background Patients with bleeding complications during left ventricular assist device (LVAD) support often require a reduction in the recommended warfarin plus aspirin regimen. To characterize those who can be safely managed with a reduced anti-thrombotic strategy, the TRACE (STudy of Reduced Anti-Coagulation/Anti-platelEt Therapy in Patients with the HeartMate II LVAS) study was initiated in the United States (U.S.) and Europe. Methods The TRACE U.S. arm enrolled HeartMate II (HMII; Thoratec) outpatients on a regimen of reduced anti-thrombotic therapy (RT), defined as vitamin K antagonist (warfarin) only, aspirin only, or no anti-thrombotic agent. The indication for RT, changes in anti-thrombotic therapies, and patient outcomes after RT were documented. Results for patients reaching 12 months or outcome are presented here. Results Between April 2012 and June 2013, 100 HMII outpatients (85% men) on RT (median age 64.5 [interquartile range, 32, 82] years, 61% with ischemic etiology, 69% destination therapy) were enrolled from 9 U.S. sites. The primary reason for RT initiation was in response to a bleeding event (82%). Pharmacotherapy at RT initiation included warfarin only (38%), aspirin only (28%), or no anti-thrombotic agent (34%). Freedom from ischemic stroke at 1 year was 93.8% ± 2.5%, and freedom from device thrombosis was 92.7% ± 2.7%. Despite RT, a subsequent bleeding event occurred in 52%. Conclusions Reducing anti-thrombotic therapies in response to bleeding among HMII patients was achievable but may be associated with a higher risk for device thrombosis. Furthermore, despite an RT strategy, bleeding often will persist in those prone to such events. [ABSTRACT FROM AUTHOR]

Background: Data for left ventricular assist devices (LVADs) in patients with noninotrope-dependent heart failure (HF) are limited.Objectives: The goal of this study was to evaluate HeartMate II (HMII) LVAD support versus optimal medical management (OMM) in ambulatory New York Heart Association functional class IIIB/IV patients meeting indications for LVAD destination therapy but not dependent on intravenous inotropic support.Methods: This was a prospective, multicenter (N = 41), observational study of 200 patients (97 LVAD, 103 OMM). Entry criteria included ≥1 hospitalization for HF in the last 12 months and 6-min walk distance (6MWD) <300 m. The primary composite endpoint was survival on original therapy with improvement in 6MWD ≥75 m at 12 months.Results: LVAD patients were more severely ill, with more patients classified as Interagency Registry for Mechanically Assisted Circulatory Support profile 4 (65% LVAD vs. 34% OMM; p < 0.001) than 5 to 7. More LVAD patients met the primary endpoint (39% LVAD vs. 21% OMM; odds ratio: 2.4 [95% confidence interval: 1.2 to 4.8]; p = 0.012). On the basis of as-treated analysis, 12-month survival was greater for LVAD versus OMM (80 ± 4% vs. 63 ± 5%; p = 0.022) patients. Adverse events were higher in LVAD patients, at 1.89 events/patient-year (EPPY), primarily driven by bleeding (1.22 EPPY), than with OMM, at 0.83 EPPY, primarily driven by worsening HF (0.68 EPPY). Most patients (80% LVAD vs. 62% OMM; p < 0.001) required hospitalizations. Health-related quality of life (HRQol) and depression improved from baseline more significantly with LVADs than with OMM (Δ visual analog scale: 29 ± 25 vs. 10 ± 22 [p < 0.001]; Δ Patient Health Questionnaire-9: -5 ± 7 vs. -1 ± 5 [p < 0.001]).Conclusions: Survival with improved functional status was better with HMII LVAD compared with OMM. Despite experiencing more frequent adverse events, LVAD patients improved more in HRQol and depression. The results support HMII use in functionally limited, noninotrope-dependent HF patients with poor HRQoL. (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device [LVAD] and Medical Management [ROADMAP]; NCT01452802). [ABSTRACT FROM AUTHOR]

Continuous-flow left ventricular assist devices (CF-LVAD) are now providing years of safe circulatory support with enhanced quality of life. We present four cases of patients with advanced heart failure who received support for greater than 5-years with the HeartMate II CF-LVAD. One patient continues with support at 7.5 years and has decided to not undergo cardiac transplantation. Another patient has also had LVAD support for 7.7 years, initially with a pulsatile flow LVAD, and then was switched to the HeartMate II, which has continued to support him for the last 6.6 years. Two other patients have undergone heart transplant after support times of 5.46 years and 5.75 years. Few complications occurred and the patients had very active lifestyles during support. Explant analysis revealed very low bearing wear and minimal pannus. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background During left ventricular assist device implantation, a surgical tunneling technique to keep the entire driveline (DL) velour portion in the subcutaneous tunnel, resulting in a silicone-skin interface (SSI) at the exit site, has been adopted by many centers. To assess long-term freedom from DL infection associated with this technique, a multicenter SSI registry was initiated. It was hypothesized that the modified tunneling technique is associated with at least 50% reduction in DL infection at 1 year post-implant compared with the velour-to-skin method used in the HeartMate II (HMII) Destination Therapy (DT) trial. Methods SSI is a retrospective and prospective registry of patients who have received the HMII device. Results are reported from the retrospective cohort, which consists of 200 patients who were implanted during the period 2009–2012 with the SSI tunneling method and on HMII support for at least 10 months at the time of enrollment. The prevalence and incidence of DL infection after left ventricular assist device implantation in the SSI retrospective cohort were determined and compared with a control group of 201 patients also on HMII support for at least 10 months from the HMII DT clinical trial who were implanted during the period 2007–2009 using the traditional method in which a small section of the velour portion of the DL was externalized. Results The 1-year and 2-year prevalence rates of DL infection were 9% and 19% in the SSI patient group compared with 23% and 35% in the control group (hazard ratio 0.49, 95% confidence interval 0.33–0.73, p < 0.001). The event-per-patient year was 0.11 and 0.22 for the SSI and control groups, respectively ( p < 0.001). Based on a multivariate analysis, age and DL exit side were the only independent variables associated with DL infection. Effects of management changes over the eras were not studied and could have contributed to the findings. Conclusions These results suggest that leaving the entire DL velour portion below the skin is associated with 50% reduction in DL infection compared with results from the HMII DT trial. [ABSTRACT FROM AUTHOR]