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Background Drive-line infections and sepsis lead to significant morbidity and even mortality in patients with ventricular assist devices (VADs). The HeartWare HVAD system is unique compared with other VAD systems in that it has a thin, flexible drive-line and is implanted directly into the pericardial space without the need for a pump pocket. We reviewed 332 patients receiving the HVAD in the pivotal ADVANCE Bridge to Transplant (BTT) trial and Continued Access Protocol (CAP) to determine the incidence of drive-line infections and sepsis. Methods Summary statistics of outcomes and Kaplan–Meier freedom-from-event analyses were performed. The Cochran–Mantel–Haenszel test for homogeneity was used to determine whether there was any site effect on rates of either drive-line exit-site or sepsis infections. Results Drive-line exit-site infections occurred in 16.9% (56 of 332) of patients (0.25 event per patient-year [EPPY]). These infections were primarily treated with antibiotics and most occurred >30 days post-implant (88%, or 66 of 75 drive-line infections). Sepsis occurred in 17.2% (57 of 332) of patients (0.23 EPPY), and sepsis events occurred more frequently >30 days post-implant (86%, or 60 of 70 sepsis events). Of patients with sepsis, 17.5% (10 of 57) died due to sepsis-related neurologic events (7 of 10) and multisystem organ failure (2 of 10) and cardiopulmonary failure (1 of 10), whereas there were no deaths related to drive-line infections. In addition, 17.5% (10 of 57) of patients had a stroke event while under treatment for sepsis (7 hemorrhagic and 3 ischemic strokes), and 3.5% (2 of 57 patients with sepsis) had a device exchange for VAD thrombus (4 days before and 1 day after sepsis diagnosis). Patients with drive-line infections or sepsis had a larger body mass index compared to those without infection (29.4 vs 27.6 kg/m 2 , p = 0.015), and were more frequently diabetic (43.7% vs 31.2%, p = 0.034). Although there was no negative impact on survival in patients with drive-line exit-site infections, there was a trend for reduced survival in patients with sepsis events when compared to those patients without sepsis. Conclusions The incidence of drive-line infection and sepsis was low in patients receiving the HVAD pump. Despite a trend toward reduced survival in patients with sepsis events, the overall survival of patients with either drive-line infections or sepsis was excellent.

Background Preexisting valve pathology is common in patients with end-stage heart failure undergoing left ventricular assist device (LVAD) placement. The indications and subsequent benefits of performing valvular procedures in these patients are unclear. The objective of this study was to determine the impact of performing concurrent surgical valve procedures in a large cohort of patients receiving LVADs. Methods One thousand one hundred six patients received the HeartMate II (HMII) LVAD in the bridge to transplant (n = 470) and destination therapy (n = 636) clinical trials. Of these, 374 patients (34%) had concurrent cardiac surgery procedures as follows: 242 patients (21%) with 281 concurrent valve procedures (VP) (aortic 80, mitral 45, and tricuspid 156), and 641 patients had only HMII LVAD. The focus of this study was to determine the clinical outcomes of patients undergoing HMII + VP compared with those who received HMII alone. Results Patients undergoing HMII + VP were significantly older, had higher blood urea nitrogen levels and central venous pressure, and decreased right ventricular stroke work index; intraoperatively, the median cardiopulmonary bypass times were also longer. The unadjusted 30-day mortality was significantly higher in patients undergoing HMII + VP (10.3% vs 4.8% for LVAD alone, P = .005). Subgroup analysis of individual VPs showed that higher mortality occurred in patients with HMII plus 2 or more VPs (13.5%, P = .04) followed by trends for increased mortality with HMII plus mitral alone (11.5%, P = NS), HMII plus aortic alone (10.9%, P = NS), and HMII plus tricuspid (8.9%, P = NS) procedures. Of these various groups, only patients undergoing HMII + isolated aortic VP ( P = .001) and HMII + multiple VPs ( P = .046) had significantly worse long-term survival compared with patients undergoing HMII alone. Right heart failure and right ventricular assist device use was increased in patients undergoing VPs, but there was no difference in the incidence of bleeding or stroke. Conclusions Patients frequently require concurrent VPs at the time of LVAD placement; these patients are sicker and have higher early mortality. Furthermore, right ventricular dysfunction is increased in these patients. Further studies to develop selection criteria for concurrent valve interventions are important to further improve clinical outcomes.

Background Liver dysfunction in left ventricular assist device (LVAD) recipients is common both before and after implantation. Postoperative liver dysfunction (PLD) develops in some LVAD recipients without preoperative liver dysfunction. The aim of this study was to assess clinical outcomes in such patients. Methods Records of all patients undergoing implantation of a HeartMate II (HM II, St. Jude Medical, Inc, Minneapolis, MN) LVAD at a single center at the University of Minnesota from January 2005 through June 2014 were analyzed. PLD was defined by hypertransaminasemia or hyperbilirubinemia, or both, during the hospitalization for LVAD implantation. Results During the study period, 284 patients underwent HM II implantation. Excluded from analysis were 14 recipients with preoperative liver dysfunction. In the final cohort (n = 270), there were no major difference in preoperative characteristics among those patients with versus without PLD. PLD developed in 129 (47.8%) recipients: 16 (12.4%) had isolated hypertransaminasemia (group I), 76 (58.9%) had isolated hyperbilirubinemia (group II), and 37 (28.7%) had combined hypertransaminasemia and hyperbilirubinemia (group III). Group III LVAD recipients had significantly greater rates of 30-day, 90-day, and 1-year mortality, along with significantly higher transfusion requirements and higher rates of renal replacement therapy, prolonged ventilation, and vasopressor use. Moreover, their mortality risk was significantly higher than that of PLD-free LVAD recipients (hazard ratio, 4.6; 95% confidence interval, 2.1 to 10.1; p Conclusions Isolated hyperbilirubinemia is common after LVAD implantation. In this study, it was not associated with an increase in early or midterm postoperative mortality. However, postoperative combined transaminasemia and hyperbilirubinemia was associated with a significant increase in early and midterm morbidity and mortality. Further research into the pathogenesis of post-LVAD PLD is necessary.

Introduction Post cardiac transplant outcomes of patients supported with the Heartmate 3 left ventricular assist device (LVAD) have not been previously reported. The purpose of this analysis was to report status at the time of transplant and survival by continuous flow (CF) device type. Hypothesis Patients supported with a HeartMate 3 LVAD will have a similar post-transplant survival to other contemporary CF-LVADs. Methods The study cohort included adult patients supported on contemporary, continuous flow (CF) devices in the UNOS registry who underwent cardiac transplant between the years 2014-2018, prior to the 2018 UNOS allocation system change. The analysis was limited to patients who underwent initial LVAD implantation in 2014 and beyond to allow post-transplant comparisons among patients with similar LVAD support times. Multivariable cox regression was performed to assess the association between LVAD type and post-transplant survival. Results The study cohort consisted of 3,117 patients who underwent cardiac transplant while on LVAD support (Heartmate 2: 1,545, Heartmate 3: 179, HeartWare (HVAD): 1,393). No patients supported on Heartmate 3 devices were transplanted for pump thrombosis during this time period. Patients supported on the Heartmate 3 were less likely to be listed 1A for complications at the time of transplant (Heartmate3: 28 % (51/179), Heartmate 2: 44 % (680/1,545), HVAD 37 % (511/1,393, p Conclusions Patients supported with Heartmate 3 LVAD at the time of transplant have similar survival after transplant compared to other contemporary CF devices in this early experience. No patients with a Heartmate 3 were transplanted for device thrombosis.

Introduction The purpose of this study was to summarize survival and adverse events in patients with cardiogenic shock supported by the 5.0 Impella (Abiomed Inc, Danvers, MA USA) via axillary or subclavian access. Methods We performed a literature review of PUBMED and OVID databases for published, peer-reviewed manuscripts in English through March 31, 2019 for patients supported by Impella 5.0 devices. Only peer-reviewed studies with axillary or subclavian access, greater than or equal to 5 patients, and with clear reporting of survival and adverse events were included. A random effects meta-analysis was then performed. Results The ten studies included in the final analysis (n=125 patients) evaluated 30-day survival and adverse events such as cerebrovascular accident, limb ischemia, hemolysis, major bleeding, device malfunction, pump thrombosis, and infection. The mean age of patients across studies was 57 +/- 4.7 years, 83% were male, 43% were post-acute myocardial infarction. The mean length of support was 13.4 +/- 8.2 days. The 30-day survival was 64% (95% CI 51.7- 76.6 %). Percentages of patient experiencing adverse events are reported in Figure 1. Conclusions This analysis demonstrates that axillary or subclavian Impella 5.0 has a relatively low adverse event rate and can be used for longer periods of time than is reported for other forms of temporary support.

Purpose The EUROMACS Right-Sided Heart Failure Risk Score was developed to predict right ventricular failure (RVF) after left ventricular assist device (LVAD) placement. The performance of this model outside the derivation cohort has not been tested. Methods EUROMACS Right-Sided Heart Failure Risk Scores were calculated and assessed as predictors of post-operative RVF in a single center continuous flow (CF) LVAD cohort (n=451). Only patients with complete data for risk score calculation and RVF determination were included in the analysis (n = 254). RVF was defined as RVAD within 30 days, continuous inotropic support ≥ 14 days, or inhaled pulmonary vasodilatory use for > 48 hours after LVAD implantation. Results Thirty-nine percent of patients (100/254) had post-operative RVF, however only 9% (23/254) required prolonged inotropic support and 5% (12/254) required RVAD placement. Development of RVF after LVAD was associated with a 45% increase the hazards rate of death on LVAD support (HR 1.45, 95 % CI 0.98-2.2, p =0.066), however this was not statistically significant. The increase in mortality associated with RVF was largely driven by patients who required RVAD support (HR 4.6, 95 % CI 2.3- 9.1, p Conclusion The EUROMACS Right-Sided Heart Failure Risk Score had poor discrimination in this LVAD dataset. These findings further emphasize the difficulty of predicting RVF after LVAD placement. Further work is required to enhance our understanding pre- LVAD right ventricular physiology and to accurately risk stratify patients.

Purpose Right ventricular failure (RVF) after LVAD implantation remains difficult to predict pre-operatively. As right heart failure is associated with muscle wasting, we hypothesized pectoralis muscle tissue attenuation quantified on pre-operative CT scans would enhance the prediction of RVF after LVAD implantation. Methods Patients with a first time continuous flow (CF) LVAD implants from Houston Methodist (n=208) and University of Minnesota (n=224) with complete post-operative RVF data were included in the analysis (total n = 432). As we wanted to create a model that applied to INTERMACS 2-5 patients, we limited the analysis to INTERMACS 2 and higher patients. RVF was defined as RVAD within 30 days of implantation or requiring inotropic support ≥ 14 days. To develop an RVF Risk Model, we implemented backward model selection using logistic regression. Thirty-one candidate hemodynamic and clinical predictors were tested during model development. This method was repeated limiting the analysis to patients with mean pectoralis Hounsfield units (PHUm) available by pre-operative CT scans (total n=188). Receiver-operating characteristic (ROC) curves for the RVF Risk Model and the Pectoralis RVF Risk Model were then generated. Results The RVF Risk Model included the following variables: albumin, log total bilirubin, and INTERMACS profile. The AUC for this model was 69% (95% CI: 62-76%). The Pectoralis RV Risk Model included albumin, creatinine and PHUm. The AUC for this model was 73% (95 % CI: 63-82%). Conclusion Pectoralis muscle tissue attenuation was predictive of RVF after LVAD implantation in this multicenter study. Incorporating this measure into a RVF Risk Model improved model performance. This measure is quantifiable, repeatable, and appears to add information to traditional preoperative assessment.

Purpose We have previously shown that pectoralis muscle mass and tissue attenuation obtained on preoperative CT scans were powerful predictors of mortality after LVAD implantation using single center data. This analysis confirms those findings in a separate LVAD dataset and presents a novel prediction model developed across centers. Methods Patients with chest CTs performed ≤ 3 months before LVAD implantation at University of Minnesota (n=143) and Houston Methodist Hospital (n=133) were identified from larger cohorts (University of Minnesota n=353, Houston Methodist =278). Unilateral pectoralis muscle mass indexed to body surface area (PMI) and attenuation (approximated by mean Hounsfield units; PHUm) were measured on preoperative chest CT scans. To develop the Pectoralis Muscle Risk Score (PMRS), we implemented a cross-validated model selection using Cox's proportional hazards regression model with censoring at transplantation. The final model included PHUm, sex, albumin, year of implant, body mass index, bridge to transplant, INTERMACS profile, and presence or absence of contrast. Receiver-operating characteristic (ROC) curves for 30, 90, and 365 day survival were generated for the model and compared to the HeartMate II Risk Score (HMRS). Results The Pectoralis Risk Score outperformed HMRS at each of the pre-specified time-points. The AUC for PMRS for predicting survival at 30, 90, and 365 days was 78%, 76%, and 76%, respectively. The HMRS had AUC of 63%, 67%, and 63% (Figure). Conclusion The Pectoralis Muscle Risk Score had favorable discrimination in this multicenter dataset. These skeletal muscle measures, which are associated with heart failure stage and frailty, appear to add important information to pre-operative risk assessment.

Purpose The role of routine right heart catheterization (RHC) to evaluate for left ventricular (LV) unloading remains unclear in patients with continuous flow left ventricular assist devices (CF-LVAD). We hypothesized that persistently elevated pulmonary capillary wedge pressure (PCWP) would be associated with increased mortality on CF-LVAD support. Methods A single center continuous flow LVAD cohort (n=451) was queried for patients with follow-up RHC data at 6 months +/- 3 months (n=179). To determine the relationship between follow-up PCWP and mortality, a multivariable cox regression analysis was performed. Results The mean age of the study cohort was 57±13 years. 79% (141/179) were males, 56% (101/179) had ischemic cardiomyopathy and 74% (133/179) were designated bridge to transplant (BTT). The median follow-up time on LVAD support after RHC was 4.4 years. The only pre-implant variables that were associated with elevated PCWP in the multivariate analysis were renal function and BMI (each 2.5 unit increase in BMI was associated with an adjusted 0.6 mmHg increase in follow-up PCWP, 95% CI 0.2-0.9 mmHg, p=0.004; each 0.5 mg/dL increase in creatinine was associated with a 1.2 mmHg increase in follow-up PCWP, 95% CI 0.4-2.1, p=0.003). In the final multivariate models, each 5 mmHg increase in PCWP at the time of RHC was associated with a 22% increase in the hazards rate of death during follow-up (adjusted HR 1.2, 95% CI 1.01-1.47, p=0.039). All models were adjusted for age, sex, INTERMACS profile, body mass index, bridge to transplant status and renal function. Conclusion Incomplete LV unloading following CF-LVAD implantation is associated with increased all-cause mortality. Our results emphasize the importance of invasive hemodynamic optimization in this patient population. Further studies are warranted to determine the optimal filling pressures in patients with CF-LVAD.

Purpose We have previously demonstrated that pectoralis muscle mass and tissue attenuation measured on preoperative CT scans were powerful predictors of mortality after LVAD implantation. These measurements were made with specialized software (Slice-O-Matic) which is not accessible to advanced heart failure teams. The purpose of this analysis was to determine the correlation between pectoralis muscle measures made with specialized software vs. routinely available CT software (PACS). Methods A random sample CT scans (n=57) was selected from our larger LVAD cohort with previously quantified pectoralis muscle measures by Slice-O-Matic Software (larger cohort n=141). Unilateral pectoralis muscle mass indexed to body surface area (PMI) and attenuation (approximated by mean Hounsfield units; PHUm) were re-measured on preoperative chest CT scans by a local radiologist using PACS software. Correlation between Slice-O-Matic and PACS pectoralis muscle measures was performed with Pearson analysis. These measures (PACS) were then assessed as predictors of mortality after LVAD implantation using multivariate cox regression. Results We observed a high correlation between pectoralis muscle measures using both techniques (R = 0.95 for PMI, R = 0.94 for PHUm). For the pectoralis measures quantified by PACS, each unit increase in PMI was associated with a 31% reduction in the hazard of death after LVAD (adjusted HR 0.69, 95% CI 0.48-0.99, p = 0.046). Each 5-unit increase in PHUm was associated with a 39% reduction in the hazard of death after LVAD (adjusted HR 0.61, 95% CI 0.38-0.96, p Conclusion Pectoralis muscle measurements can be performed by local radiologists using routinely available software. These measures are predictive of morality following LVAD. This is an important first step in delivering a predictive model incorporating this measure into real world practice.

Purpose Limited data exists regarding concentrated factor administration during continuous flow left ventricular assist device (CF-LVAD) implantation and subsequent neurologic events. While the hemocompatability profile of CF pumps are presently changing, this is the largest concentrated factor experience reported in a CF-LVAD population to date. Methods The study cohort consisted of patients with a first time HeartMate II implantation at a single center (n=330). Patients were coded as receiving concentrated factor if prothrombin 4 factor complex or recombinant factor VIIa was charted intra-operatively or within 48 hours of device implantation. Time to first stroke (ischemic or hemorrhagic) was recorded using INTERMACS definitions. Multivariate cox regression was used to assess the association between concentrated factor administration and the time to first stroke. Results Eighteen percent of patients (60/330) received concentrated factor intra-operatively or within 48 hours of device implantation. During a median follow up time of 488 days, 47 patients developed a stroke on LVAD support (51% ischemic, 49% hemorrhagic). In the final multivariate models, concentrated factor administration was not significantly associated with all cause stroke (HR 0.70, 95% CI 0.32-1.72, p = 0.50), ischemic stroke (HR 1.23, 95% CI 0.43-3.56, p = 0.7), or hemorrhagic stroke (0.39, 95% CI 0.09-1.75, p =0.22). All models were adjusted for age, INTERMACS profile, implant year, ischemic cardiomyopathy diagnosis, diabetes, presence or absence of atrial fibrillation at implantation, and discharge pump speed. Conclusion While there was no statistical association with stroke rates after concentrated factor administration, the hazard ratios suggests a protective effect against hemorrhagic events and a slight increase in ischemic events with factor administration. Larger data will be needed to fully answer this question in the contemporary continuous flow era.

Purpose Little data exist regarding the surgical complexity of Heartmate2 (HM2) to HeartMate3 (HM3) pump exchange for the indication of HM2 pump thrombosis. In this analysis, we compare the operative and post hospital course between HM2 to HM2 vs. HM2 to HM3 exchange for pump thrombosis in a small case series. Methods A single center cohort of HeartMate 2 patients (n=351) was evaluated for exchange data. Individual patients with an exchange for HM2 pump thrombosis (n=29) were included in the analysis (HM2 to HM2 n=24, HM2 to HM3 n=5). Peri-operative and immediate post-operative outcomes were compared with t tests, rank sum and fishers exact tests, where appropriate. Results Baseline characteristic of patients undergoing HM2 to HM2 exchange and HM2 to HM3 exchange were similar (Table). All patients undergoing HM2 to HM2 exchange underwent a subcostal approach. All patients with a HM2 to HM3 exchange underwent median sternotomy. HM2 to HM3 pump exchange had a longer median cardiopulmonary bypass time, a longer median ICU stay, longer median ventilator days, and overall length of stay than HM2 to HM2 pump exchange (Table). Six months after surgery, no patients who underwent HM2 to HM3 exchange had recurrent hemolysis, while 7/24 (29%) who underwent HM2 to HM2 exchange had recurrent hemolysis. Conclusion HM2 to HM3 pump exchange is feasible, however this operation is more complex and has a longer recovery time than HM2 to HM2 subcostal exchange. It will be important to consider minimally invasive strategies going forward to allow this exchange to be performed with less morbidity. A larger sample size will be required to analyze long term outcomes after HM2 to HM3 exchange.

Purpose As skeletal muscle mass and quality decrease with heart failure progression, we hypothesized that pectoralis muscle mass and tissue attenuation measured on pre-left ventricular assist device (LVAD) CT scans would add meaningful heart failure severity stratification beyond INTERMACS profile alone. Methods Patients with chest CTs performed ≤ 3 months prior to LVAD implantation at University of Minnesota (n=143) and Houston Methodist Hospital (n=133) were identified from the larger cohorts (University of Minnesota n=353, Houston Methodist =278). Unilateral Pectoralis muscle mass indexed to body surface area and pectoralis muscle attenuation (approximated by mean Hounsfield units; PHUm) was measured on pre-operative chest CT scans. Patients within each INTERMACS profile were separated into HIGH and LOW pectoralis muscle measure groups (HIGH = upper two pectoralis muscle tertiles, LOW = lowest pectoralis muscle tertiles, repeated for both PMI and PHUm). Kaplan Meier survival analyses were performed to compare mortality among INTERMACS profiles by HIGH and LOW pectoralis muscle measure groups. Results INTERMACS 3 and 4 patients in the HIGH PHUm groups had the highest survival on LVAD support (2-year survival 80%, 95% CI 70 - 87%, p =0.0002). When the analysis was repeated for PMI, INTERMACS 3 and 4 patients in the HIGH PMI groups had the highest survival on LVAD support (2-year survival 80%, 95% CI 70 - 87%, p = 0.004). Conclusion INTERMACS 3 and 4 patients with the highest pectoralis muscle measures had the best survival on mechanical support. As skeletal muscle wasting is accelerated with advanced heart failure, these measures may help identify patients in whom watchful waiting is not safe. Further data will be required to confirm this hypothesis.

We report a case in which a recipient of a HeartWare® HVAD left ventricular assist device (HeartWare, Framingham, MA, USA) was unable to undergo standard outflow graft anastomosis to the ascending aorta due to severe aortic calcification. The outflow graft of the device was instead anastomosed to the descending aorta.

Pump thrombosis is a dreaded complication of long-term implantable ventricular assist devices. No guidance exists regarding the diagnosis and management of this entity despite its significant morbidity. After considerable thought and deliberation, a group of leading investigators in the field of mechanical support propose an algorithm for the diagnosis and management of this vexing entity based on clinical symptoms and serologic and imaging studies.

The role of mechanical circulatory support for cardiopulmonary failure is expanding. Anticoagulation in the setting of static blood, hypercoagulable states, extracorporeal circuits, and surgery presents an intricate and delicate balance. We present a patient with large, biventricular thrombi during and succeeding biventricular mechanical support. Management of the thrombi and device selection in this patient are discussed.

Background Although continuous-flow left ventricular assist devices (LVAD) are durable and reliable, device replacement will be inevitable in some patients. We evaluated the incidence and outcomes of pump replacement procedures with the HeartMate II (Thoratec Corporation, Pleasanton, CA) LVAD. Methods Data were obtained from 1,128 patients implanted from March 2005 to January 2010 with the HeartMate II during the clinical trials for bridge to transplant and destination therapy. The operative mortality associated with the replacement procedure was determined. Results The mean duration of HeartMate II support was 568 ± 535 days (cumulative duration: 1,755 patient-years, longest: 6.5 years). A total of 72 (6.4%) patients underwent 79 LVAD replacements (0.045 events/patient-year) of which 2 were in the initial operation and 77 in separate procedures. Reasons for replacement were percutaneous lead damage (36 events, 3.0%), device thrombosis (25 events, 2.1%), infection (7 events, 0.6%), and miscellaneous other (11 events, 0.9%). The median time to pump replacement was 428 days (range 0 to 1,474). Of the 77 replacement procedures, there were 5 (6.5%) operative deaths within 30 days. The causes of death were device thrombosis, right heart failure, multisystem organ failure, and bleeding. One year after exchange (median 2.1 years after initial implant), 30% had died, 5% were transplanted, and 65% were ongoing and alive. Conclusions HeartMate II device failure requiring pump replacement is infrequent, but when required can be done safely. These data continue to provide encouraging evidence supporting HeartMate II use for long-term circulatory support.

Objectives Continuous-flow left ventricular assist devices have become the standard of care for patients with heart failure requiring mechanical circulatory support as a bridge to transplant. However, data on long-term post-transplant survival for these patients are limited. We evaluated the effect of continuous-flow left ventricular assist devices on postcardiac transplant survival in the current era. Methods All patients who received a continuous-flow left ventricular assist device as a bridge to transplant at a single center from June 2005 to September 2011 were evaluated. Results Of the 167 patients who received a continuous-flow left ventricular assist device as a bridge to transplant, 77 (46%) underwent cardiac transplantation, 27 died before transplantation (16%), and 63 (38%) remain listed for transplantation and continued with left ventricular assist device support. The mean age of the transplanted patients was 54.5 ± 11.9 years, 57% had an ischemic etiology, and 20% were women. The overall mean duration of left ventricular assist device support before transplantation was 310 ± 227 days (range, 67-1230 days). The mean duration of left ventricular assist device support did not change in patients who had received a left ventricular assist device in the early period of the study (2005-2008, n = 62) compared with those who had received a left ventricular assist device later (2009-2011, n = 78, 373 vs 392 days, P = NS). In addition, no difference was seen in survival between those patients supported with a left ventricular assist device for fewer than 180 days or longer than 180 days before transplantation ( P = NS). The actuarial survival after transplantation at 30 days and 1, 3, and 5 years by Kaplan-Meier analysis was 98.7%, 93.0%, 91.1%, and 88.0%, respectively. Conclusions The short- and long-term post-transplant survival for patients bridged with a continuous-flow left ventricular assist device in the current era has been excellent. Furthermore, the duration of left ventricular assist device support did not affect post-transplant survival. The hemodynamic benefits of ventricular unloading with continuous-flow left ventricular assist devices, in addition to their durability and reduced patient morbidity, have contributed to improved post-transplant survival.

Institutional Affiliations Co-chairs Feldman D: Minneapolis Heart Institute, Minneapolis, Minnesota, Georgia Institute of Technology and Morehouse School of Medicine; Pamboukian SV: University of Alabama at Birmingham, Birmingham, Alabama; Teuteberg JJ: University of Pittsburgh, Pittsburgh, Pennsylvania Task force chairs Birks E: University of Louisville, Louisville, Kentucky; Lietz K: Loyola University, Chicago, Maywood, Illinois; Moore SA: Massachusetts General Hospital, Boston, Massachusetts; Morgan JA: Henry Ford Hospital, Detroit, Michigan Contributing writers Arabia F: Mayo Clinic Arizona, Phoenix, Arizona; Bauman ME: University of Alberta, Alberta, Canada; Buchholz HW: University of Alberta, Stollery Children’s Hospital and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada; Deng M: University of California at Los Angeles, Los Angeles, California; Dickstein ML: Columbia University, New York, New York; El-Banayosy A: Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania; Elliot T: Inova Fairfax, Falls Church, Virginia; Goldstein DJ: Montefiore Medical Center, New York, New York; Grady KL: Northwestern University, Chicago, Illinois; Jones K: Alfred Hospital, Melbourne, Australia; Hryniewicz K: Minneapolis Heart Institute, Minneapolis, Minnesota; John R: University of Minnesota, Minneapolis, Minnesota; Kaan A: St. Paul’s Hospital, Vancouver, British Columbia, Canada; Kusne S: Mayo Clinic Arizona, Phoenix, Arizona; Loebe M: Methodist Hospital, Houston, Texas; Massicotte P: University of Alberta, Stollery Children’s Hospital, Edmonton, Alberta, Canada; Moazami N: Minneapolis Heart Institute, Minneapolis, Minnesota; Mohacsi P: University Hospital, Bern, Switzerland; Mooney M: Sentara Norfolk, Virginia Beach, Virginia; Nelson T: Mayo Clinic Arizona, Phoenix, Arizona; Pagani F: University of Michigan, Ann Arbor, Michigan; Perry W: Integris Baptist Health Care, Oklahoma City, Oklahoma; Potapov EV: Deutsches Herzzentrum Berlin, Berlin, Germany; Rame JE: University of Pennsylvania, Philadelphia, Pennsylvania; Russell SD: Johns Hopkins, Baltimore, Maryland; Sorensen EN: University of Maryland, Baltimore, Maryland; Sun B: Minneapolis Heart Institute, Minneapolis, Minnesota; Strueber M: Hannover Medical School, Hanover, Germany Independent reviewers Mangi AA: Yale University School of Medicine, New Haven, Connecticut; Petty MG: University of Minnesota Medical Center, Fairview, Minneapolis, Minnesota; Rogers J: Duke University Medical Center, Durham, North Carolina

Patterns of weight change after implantation of a continuous-flow left ventricular assist device (CF-LVAD) can affect transplant candidacy and may influence outcomes. We evaluated changes in weight over a 24-month period from a national LVAD clinical trial database.A retrospective analysis was performed of 896 patients enrolled into the HeartMate II Clinical trials for bridge-to-transplant and destination therapy from March 2005 to January 2009. The patients were divided into 4 groups: underweight (body mass index [BMI]18.5 [kg/m(2)]); normal (BMI 18.5 to 29.9); obese (BMI 30 to 34.9); and extremely obese (BMI ≥ 35). Baseline BMI was compared with BMI at 6 months and 24 months after implant. BMI change10% of baseline was considered clinically significant.At 6 months, underweight and normal-weight patients had significant increases in BMI, with effects sustained up to 24 months (p0.01). Underweight patients gained weight most often, with 75% showing clinically meaningful weight gain at 24 months. Obese and extremely obese patients, in contrast, did not experience weight change over the same period. Pre-albumin levels improved from baseline to 6 months in all patients.Underweight and normal-weight patients had an increase in BMI after LVAD implantation, and these changes persisted through 24 months. The BMIs of obese and extremely obese patients remained unchanged. Nutritional status improved in all groups.

Temporary mechanical circulatory support (MCS) is a common supportive therapy in cardiogenic shock and high-risk coronary intervention. The proliferation of new percutaneous MCS devices allows support to be instituted rapidly without surgical cutdown. The recent literature exploring the indications, benefits, and risks of each is reviewed. Areas discussed: Current applications of percutaneous MCS devices, including intra-aortic balloon pumps (IAPB), Impella, TandemHeart, and VA ECMO are discussed. Studies investigating each were identified through a combination of online database queries and direct extraction of single studies cited in previously-identified papers. Information on unpublished trials and registries was found on ClinicalTrials.gov. Expert commentary: Direct VADs provide a higher level of hemodynamic support compared to IABP and their early use will continue to expand. The development of percutaneous RV support systems may allow more patients to receive such therapy faster. VA ECMO is being used increasingly in CPR and in outreach programs.

Background In 2015, the Minnesota Resuscitation Consortium (MRC) implemented an advanced perfusion and reperfusion life support strategy designed to improve outcome for patients with out‐of‐hospital refractory ventricular fibrillation/ventricular tachycardia ( VF / VT ). We report the outcomes of the initial 3‐month period of operations. Methods and Results Three emergency medical services systems serving the Minneapolis–St. Paul metro area participated in the protocol. Inclusion criteria included age 18 to 75 years, body habitus accommodating automated Lund University Cardiac Arrest System ( LUCAS ) cardiopulmonary resuscitation ( CPR ), and estimated transfer time from the scene to the cardiac catheterization laboratory of ≤30 minutes. Exclusion criteria included known terminal illness, Do Not Resuscitate/Do Not Intubate status, traumatic arrest, and significant bleeding. Refractory VF / VT arrest was defined as failure to achieve sustained return of spontaneous circulation after treatment with 3 direct current shocks and administration of 300 mg of intravenous/intraosseous amiodarone. Patients were transported to the University of Minnesota, where emergent advanced perfusion strategies (extracorporeal membrane oxygenation; ECMO ), followed by coronary angiography and primary coronary intervention ( PCI ), were performed, when appropriate. Over the first 3 months of the protocol, 27 patients were transported with ongoing mechanical CPR . Of these, 18 patients met the inclusion and exclusion criteria. ECMO was placed in 83%. Seventy‐eight percent of patients had significant coronary artery disease with a high degree of complexity and 67% received PCI . Seventy‐eight percent of patients survived to hospital admission and 55% (10 of 18) survived to hospital discharge, with 50% (9 of 18) achieving good neurological function (cerebral performance categories 1 and 2). No significant ECMO ‐related complications were encountered. Conclusions The MRC refractory VF / VT protocol is feasible and led to a high functionally favorable survival rate with few complications.

The use of continuous-flow left ventricular assist devices (CF-LVADs) has revolutionized the landscape of mechanical circulatory support for patients with heart failure. Clinical trials are already testing the next generation of CF-LVADs. In this study, our objective was to review our long-term experience with the current generation of CF-LVADs, specifically, the HeartMate (HM) II (Thoratec Corp, Pleasanton, CA). In this single-center retrospective analysis, we evaluated the records of 278 consecutive patients who underwent a total of 302 HM II placements from June 2005 through June 2014. We excluded 11 patients from our final study group, who had previously undergone placement of a HM XVE that failed. We divided the remaining 267 patients into 3 equal groups of 89 patients each, by time period: group 1, June 2005 through May 2009; group 2, June 2009 through January 2012; and group 3, February 2012 through June 2014. To examine differences in survival between our 3 groups, we used time-to-event analysis, including the Kaplan-Meier method. To examine secondary outcomes (including stroke, hemolysis, gastrointestinal bleeding, pump thrombus, and transplant), we used one-way analysis of variance. For our final study group of 267 patients, the total follow-up time was 479.01 patient-years (median, 469 days). The mean age of patients was 57 years; 81.4% were male. In all, 209 (78.9%) patients underwent HM II placement as a bridge to transplant; 58 (21.1%), as destination therapy (DT). The overall survival rate was 94% at 30 days, 77% at 1 year, 65% at 2 years, 60% at 3 years, 50% at 4 years, and 48% at 5 years. In bridge to transplant patients, the survival rate was 78% at 1 year and 66% at 2 years; in DT patients, 70% and 60%. In group 1 patients, the survival rate was 94% at 30 days, 64% at 1 year, and 48% at 2 years; in group 2, 93%, 88%, and 76%; and in group 3, 94%, 77%, and 73% (P = 0.003). In the later years of our study period, from June 2009 onwards (ie, in groups 2 and 3), we noted a statistically significant increase in HM II placement as DT, a reduction of driveline infections, increasing pump exchange, increasing hemolysis, a reduced frequency of transplants, and an improved survival rate (as compared with the earlier group 1). The HM II has favorably influenced the outcomes of patients with end-stage heart failure, yet major complications still limit their survival. Improving compatibility between the pump and the individual host patient, enhancing anticoagulation strategies, and developing a totally implantable pump might further reduce complications thereby improving survival times and allowing CF-LVAD placement to be a true long-term alternative to a heart transplant.

Obscure gastrointestinal bleeding (GIB) in patients with continuous-flow left ventricular assist devices (CF-LVAD) is common. Capsule endoscopy (CE) can be used in the diagnosis of obscure GIB. Safety and outcomes of CE in patients with CF-LVAD are unknown. The aim is to define the safety and outcomes of CE in this population. Paitents with CF-LVAD undergoing CE at a single center between 2007 and 2014 were retrospectively reviewed. Thirty-four CE studies were performed. Positive CE occurred in 19 studies. No clinically significant cardiac events occurred. Medical intervention was the most common management strategy. Rebleeding after CE occurred in 10 patients. Patients with active bleeding or lesions such as arteriovenous malformations (AVM) incurred a higher risk of rebleeding, transfusion, and repeated endoscopy. CE is safe in patients with CF-LVAD. The risk of rebleeding was more common in patients with active bleeding or AVM lesions although this result did not reach statistical significance.

Mechanical circulatory support (MCS) is, as the name implies, the use of electro-mechanical devices to support the circulatory system. This support may be uni-ventricular, bi-ventricular, pulmonary, percutaneous, central, or any combination of these, depending on the clinical scenario. A large component of MCS use is in a more permanent fashion in the bridge-to-transplant (BTT) or destination therapy (DT) patient. The other scenario where MCS is used is in the acute setting as a means of supporting the patient as a bridge-to-recovery or a bridge-to-decision about long-term MCS.

Because of the obligate intravascular location of contemporary continuous-flow ventricular assist devices (CF-VADs), it is not surprising that bleeding and thrombosis are among the most common and feared complications of this therapy, respectively. Although strides have been made in our understanding of the pathophysiology of continuous flow, intravascular CF-VADs have been widely used only in the last few years, and a great deal remains less well known (or unknown). Outcomes have improved significantly over the past decade, but a deeper understanding of how these devices perturb the delicate intrinsic balance of bleeding and thrombosis is critical to guide therapy and to overcome the current obstacles to achieving a long-term safety profile comparable to that of mechanical prosthetic valves. ### Hematologic Effect of CF-VADs The hematologic effects of CF-VADs are of significant interest and importance and have recently been reviewed in detail elsewhere.1,2 Hemocompatibility refers to the interaction of prosthetic material with blood and can be measured in terms of impact on hematologic, inflammatory, or immunologic parameters, which has been observed clinically as significant and prolonged activation of endothelial and coagulation systems after CF-VAD implantation, including intercellular adhesion molecule, E-selectin, and tissue factor, for example.3 Hemocompatibility has always been a goal in pump design, along with efforts to maximize blood flow without clinically significant hemolysis, areas of stasis, turbulent flow, or retrograde flow. It has been suggested that the major complications of thrombosis, bleeding, and infection could be related to the effects of blood interaction with the VAD surface,4,5 and further optimization of surface coatings presents an appealing strategy for additional exploration.6 A better understanding of the impact of blood–VAD surface interactions with the presently used CF-VAD devices, however, is essential to evaluating the impact of novel designs or materials. A few recent observations have provided some insight …

There is a well-documented learning curve for achieving procedural efficiency and safety in transcatheter aortic valve replacement (TAVR) procedures. Collaboration between existing and new TAVR programs could help reduce the number of cases needed to achieve optimal efficiency. A multidisciplinary

Background A multicenter clinical trial conducted from 2005 to 2008 of a continuous flow left ventricular assist device (LVAD) resulted in Food and Drug Administration approval for bridge to transplantation. The purpose of this analysis was to determine changes in posttrial outcomes in widespread commercial use since the clinical trial. Methods We compared outcomes of 486 patients who received a continuous flow LVAD as a bridge to transplantation at 36 centers during the clinical trial (March 2005 to April 2008) with outcomes of 1,496 posttrial patients who received a continuous flow LVAD at 83 centers (April 2008 to September 2010 as reported to the Interagency Registry for Mechanically Assisted Circulatory Support). Results Baseline data were comparable between groups. Cumulative follow-up was 511 and 1,082 patient-years for trial and posttrial patients, respectively, and average support duration was 12.6 ± 14.0 and 8.7 ± 7.1 months. Kaplan-Meier survival improved at 1 year from 76% (trial) to 85% (posttrial). The percentage of patients undergoing transplantation in the first year decreased from 48% in the trial period to 39% in the posttrial period. Quality of life metrics improved by 3 months in both groups. Conclusions The survival rate of a large group of continuous flow LVAD patients in a real-world setting after Food and Drug Administration market approval for bridge to transplantation has improved since the clinical trial. These data show that excellent outcomes have been maintained with dissemination of new LVAD technology from a clinical trial phase to more broad based use in the period after market approval.

The effects of continuous flow left ventricular assist device (CF-LVAD) support on microvascular endothelial function in New York Heart Association (NYHA) class IV heart failure (HF) patients are currently unknown. Microvascular endothelial function was assessed by beat-to-beat plethysmographic measurement of finger arterial pulse wave signal changes for 5 min following reactive hyperemia. A group of seven NYHA class IV HF patients was evaluated before CF-LVAD placement (HF), and a second group of six NYHA class IV HF patients was evaluated 1–4 months following CF-LVAD placement (CF-LVAD). Additionally, a third group of seven age-matched healthy subjects served as controls (control). There was no significant (P > 0.05) difference among the three groups in age, weight, or height. Systolic blood pressure (BP) was significantly higher in the control group (120 ± 2 mmHg) as compared to that in the HF (97 ± 8 mmHg, P = 0.005) and CF-LVAD (106 ± 4 mmHg, P = 0.003) groups. Diastolic BP was significantly lower in the HF group (57 ± 5 mmHg) as compared to that in the control (71 ± 2 mmHg, P = 0.012) and CF-LVAD (80 ± 7 mmHg, P = 0.008) groups. The reactive hyperemic index (RHI), a measure of endothelial function, was significantly higher in the control group (2.373 ± 0.274) than in both the HF (1.543 ± 0.173, P = 0.013) and CF-LVAD (1.355 ± 0.163, P = 0.004) groups; however, there was no significant (P = 0.223) difference in RHI between the HF and CF-LVAD groups. The results of the present study demonstrate that while 1–4 months of CF-LVAD support do not negatively affect microvascular endothelial function, 1–4 months of CF-LVAD support do not significantly improve vascular function in resistance vessels.

Objectives The aim of this study was to determine whether results with the HeartMate (HM) II left ventricular assist device (LVAD) (Thoratec Corporation, Pleasanton, California) in a commercial setting are comparable to other available devices for the same indication. Background After a multicenter pivotal clinical trial conducted from 2005 to 2008, the U.S. Food and Drug Administration approved the HM II LVAD for bridge to transplantation (BTT). A post-approval study was required by the U.S. Food and Drug Administration to determine whether results with the device in a commercial setting are comparable to other available devices for the same indication. Methods The study was a prospective evaluation of the first 169 consecutive HM II patients enrolled in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) who were listed for transplant or likely to be listed. Patients were enrolled from April through August 2008 at 77 U.S. centers and followed for at least 1 year after implant. A comparison group (COMP) included all patients (n = 169 at 27 centers) enrolled in the INTERMACS registry with other types of LVADs (79% HeartMate XVE, 21% Implantable Ventricular Assist Device [Thoratec Corporation]) for the same BTT indication in the same time period. Survival rates, adverse events, and quality of life with the EuroQol EQ-5D visual analog scale were obtained in the INTERMACS registry. Results Baseline characteristics were similar, but creatinine and blood urea nitrogen were lower in the HM II versus COMP groups, and there were fewer patients in the highest-risk INTERMACS patient profile Number 1 (24% for HM II vs. 39% for COMP). Adverse event rates were similar or lower for HM II versus COMP for all events. Bleeding was the most frequent adverse event for both groups (1.44 vs. 1.79 events/patient-year). Operative 30-day mortality for HM II was 4% versus 11% for COMP. The percentage of patients reaching transplant, cardiac recovery, or ongoing LVAD support by 6 months was 91% for HM II and 80% for COMP, and the Kaplan-Meier survival for patients remaining on support at 1 year was 85% for HM II versus 70% for COMP. Quality of life was significantly improved at 3 months of support and sustained through 12 months in both groups compared with baseline. Conclusions The results in a post-market approval, actual patient care setting BTT population support the original findings from the pivotal clinical trial regarding the efficacy and risk profile of the HM II LVAD. These data suggest that dissemination of this technology after approval has been associated with continued excellent results.

Background The use of large, pulsatile left ventricular assist devices (LVADs) has been limited in women because of their small body size. Methods We compared the survival outcomes, quality of life, and adverse events in 465 patients (104 women, 361 men) with advanced systolic heart failure in their first 18 months of support with the HeartMate II (Thoratec Corp, Pleasanton, CA) continuous-flow LVAD for bridge to transplantation. Results During the first 18 months, there were no differences in survival between women and men while on LVAD support (73% ± 3% vs 73% ± 5%, p = 0.855) but fewer women (40%) underwent heart transplantation than did men (55%; p = 0.001). More women continued on support after 18 months ( p = 0.007). Median duration of support was 238 days for women and 184 days for men ( p = 0.003). Mortality was 20% for women and 19% for men ( p = 0.89). Adverse events were similar, with the exception of hemorrhagic stroke, which occurred more frequently in women (0.10 vs 0.04 events/patient-year, p = 0.02), and device-related infections, which occurred less frequently in women (0.23 vs 0.44, p = 0.006). Functional capacity and quality of life at 6 months improved significantly in women and men. Conclusions Continuous-flow left ventricular assistance as a bridge to transplantation is associated with similar survival rates in women and men. Differences observed in higher stroke rates and fewer infections among women require further study.

Left ventricular assist device (LVAD) support is an accepted treatment of patients with end-stage heart failure. The increased applicability and excellent results with LVADs have revolutionized the treatment options available for such patients. Success with LVADs as bridge-to-transplant therapy has led to their successful use as an alternate to a transplant (ie, as destination therapy [DT]). The use of these devices as DT represents a relatively newer but growing indication. Until recently, most patients who have undergone LVAD implantation have been supported by pulsatile devices. Newer continuous-flow (CF) pumps have resulted in superior outcomes, including significantly reduced complication rates with improved durability over first-generation pulsatile design pumps. However, as with all new technology, the newer LVADs have introduced management challenges that were either unimportant or absent with pulsatile LVADs. This article reviews the current state of left ventricular devices, focusing on the CF pumps that currently dominate the field, including clinical outcomes, the physiologic and pathologic effects that are associated with CF pumps, and their unique management issues and complications.

Background: Approximately 20,000 permanent pacemakers (PPMs) are implanted annually for bradycardia or atrioventricular (AV) block after cardiac surgery. Little is known about the long-term pacing and mortality outcomes and the temporal trends of these patients. Methods: We examined 6,268 consecutive patients who underwent cardiac surgery at the Minneapolis Veterans Administration Medical Center between 1987 and 2010. Patients who had a PPM within 30 days of cardiac surgery were identified. Pacemaker interrogation records were retrospectively reviewed and mortality was ascertained. Results: Overall, 141 (2.2%) patients underwent PPM implantation for high-degree AV block (55%) and bradycardia (45%), 9 ± 6 days after surgery. Age, diuretic use, cardiopulmonary bypass time (CPBT), and valve surgery were independent predictors of PPM requirement. After 5.6 ± 4.2 years of follow-up, 40% of the patients were PPM dependent. Longer CPBT (P = 0.03), PR interval >200 ms (P = 0.03), and QRS interval > 120 ms (P = 0.04) on baseline electrocardiogram predicted PPM dependency. In univariable analysis, PPM patients had a higher long-term mortality than those without PPM (45% vs 36%; P = 0.02). However, after adjusting for age, sex, type of surgery, and CPBT, PPM requirement was not associated with long-term mortality (hazard ratio 1.3; 95% confidence interval 0.9–1.9; P = 0.17). Compared to before, incidence of PPM implantation increased after the year 2000 (1.9% vs 2.6%; P = 0.04). Conclusion: The majority of patients who require PPM after cardiac surgery are not PPM dependent in the long term. Requiring a PPM after surgery is not associated with long-term mortality after adjustment for patient-related risk factors and cardiac surgical procedure. (PACE 2011; 34:331–338)

As extracorporeal membrane oxygenation systems become miniaturized, their role for rapid implementation, as an adjunct to resuscitation and high-risk percutaneous interventions, grows. We describe a percutaneous approach to short term mechanical circulatory support, in the setting of cardiogenic shock, which employs a percutaneous, self-contained, distal limb perfusion system. We feel that this technique is highly important for both interventional cardiologists and cardiothoracic surgeons as well.

The increased applicability and excellent results with left ventricular assist devices (LVADs) have revolutionized the available treatment options for patients with advanced heart failure. Pre-existing valve abnormalities are common in this population, and subsequent development of valve abnormalities after LVAD placement is also often noted. Although native mitral and tricuspid valve disease is more common in heart failure patients before LVAD placement, aortic valves are much more likely to generate abnormal pathophysiology in the LVAD patient during as well as after LVAD placement. The aim of this comprehensive review is to review aortic valve function in LVAD patients and highlight the consideration of pre-existing valve disease on patient treatment at the time of LVAD implant. The basis for structural changes leading to valve pathophysiology during and after LVAD placement will be described, providing a basis for improved clinical understanding and new strategies to prevent these conditions.

Advances in palliation of congenital heart disease have resulted in improved survival to adulthood. Many of these patients ultimately develop end-stage heart failure requiring left ventricular assist device implantation (LVAD). However, morphologic differences in the systemic ventricle of these patients require careful attention to cannula placement. We report on the evolution of our surgical technique for implanting LVADs in 3 patients with transposition of the great arteries and congenitally corrected transposition of the great arteries. Applying standard LV cannulation techniques to the systemic ventricle led us too anteriorly in our first patient, creating obstruction by the moderator band. Subsequent use of epicardial and transesophageal echocardiography allowed for intraoperative localization of the intracardiac muscular structures to identify the optimal cannulation site. The acute angle of the inflow cannula on the DeBakey LVAD (MicroMed Technology, Houston, TX) required flipping the device 180°. The HeartMate II device (Thoratec, Pleasanton, CA) could be shifted towards the midline. One patient underwent successful transplant and 2 are home waiting for a donor organ. We conclude from our experience that LVAD surgery can be safely performed in patients with congenital heart disease when implanted under echocardiographic guidance.

The discrepancy between the limited availability of donor hearts and the ever-increasing number of patients with heart failure has led to the increasing use of left ventricular assist devices (LVAD) as a bridge to transplant. One of the main complications inherent following institution of LVAD therapy is right ventricular (RV) failure, manifested by the need for inotropic and/or nitric oxide support >14 days after LVAD implant and/or the need for right-sided mechanical circulatory support. RV failure is a major contributor of significant morbidity and mortality after LVAD placement. The complex pathophysiology of RV failure, which could potentially be related to RV myocardial dysfunction, interventricular dependence, and RV afterload, has led to inconsistencies in predicting risk factors for RV dysfunction. Several strategies have evolved over the years of experience with mechanical circulatory support that have aimed to avoid as well as reduce the incidence of RV failure. It is imperative that patients who definitely need biventricular support are identified. Despite the numerous risk factors identified in many studies as well as the development of risk factor profile scores, this continues to be a challenging problem. However, the lower incidence of RV failure following LVAD in the current era is encouraging, suggesting a favorable relationship between RV unloading and function, and continuous-flow physiology.

ObjectivePulsatile left ventricular assist devices have been shown to effectively reduce pulmonary hypertension in patients with end-stage heart failure. However, it remains to be seen whether newer continuous-flow left ventricular assist devices have a similar effect on pulmonary hypertension. The objective of this study was to determine whether the HeartMate II (Thoratec Corp, Pleasanton, Calif), a continuous-flow left ventricular assist device, is effective in improving pulmonary hemodynamics in the period after left ventricular assist device support and posttransplant.MethodsFifty patients with end-stage heart failure underwent HeartMate II left ventricular assist device placement as a bridge to transplant. We evaluated their pulmonary hemodynamics with right-sided heart catheterization at baseline, after left ventricular assist device placement, and after heart transplant.ResultsThe mean age of patients was 53.7 ± 13.5 years. Ischemic etiology was present in 60% of the patients. After left ventricular assist device placement (mean duration, 135 ± 60 days), mean systolic and diastolic pulmonary artery pressures decreased significantly from a baseline of 55.2 ± 13.4 mm Hg and 27.3 ± 6.8 mm Hg, respectively, to 35.9 ± 10.8 mm Hg and 15.8 ± 6.5 mm Hg, respectively (P

Background Anti-coagulation with heparin is often used after left ventricular assist device implantation as a transition to long-term warfarin therapy. We retrospectively evaluated the effects of heparin use on thromboembolic and bleeding complications after implantation of the HeartMate II left ventricular assist device (LVAD). Methods LVAD patients ( n = 418) implanted as a bridge to transplant were divided into three groups: Group A patients (therapeutic, n = 118) received heparin and had a partial thromboplastin time (PTT) of >50 seconds on two or more occasions; Group B patients (sub-therapeutic, n = 178) had at least one PTT value in the range of 40 to 55 seconds; and Group C patients (no heparin, n = 122) had no PTT values >40 seconds. All patients were transitioned to warfarin and aspirin therapy. The following adverse events were evaluated: ischemic stroke; hemorrhagic stroke; pump thrombosis; bleeding requiring surgery; and bleeding requiring ≥2 units of packed red blood cells in 24 hours. Results There was no difference in the percentages of patients with ischemic (5%, 4%, 3%) or hemorrhagic (3%, 3%, 5%) strokes or pump thrombosis (3%, 2%, 2%) after post-operative day (POD) 3 among Groups A, B and C, respectively. From PODs 3 to 30, the percentage of patients requiring transfusion for bleeding was significantly lower for Group C (18%) than for Groups A (32%) and B (26%) ( p = 0.04); differences after 30 days were not significant. Multivariate analysis revealed that post-operative heparin use, low post-operative platelet count and low baseline hematocrit value were independent risk factors for bleeding events between PODs 3 and 30. Conclusions In patients receiving the HeartMate II LVAD who were directly transitioned to warfarin and aspirin therapy without intravenous heparin there was no short-term increase in risk of thrombotic or thromboembolic events, and bleeding requiring transfusion was significantly reduced. Additional long-term follow-up is needed to evaluate possible late effects.