Search

The process of social perspective taking holds tremendous promise as a means to facilitate conflict resolution. Despite rapidly accumulating knowledge about social perspective taking in general, scholars know little about how the type of social perspective taking affects outcomes of interest. This study tests whether different ways to “walk a mile in another’s shoes” cause different outcomes. By taking advantage of a computer-based simulation (where participants can learn about others by virtually walking around in the shoes of other characters), we assigned participants from Amazon’s Mechanical Turk (N = 842) to five different perspective taking treatments or a control condition. Results show that perspective takers who receive information about the other party foster more positive relationships and make greater concessions than participants who did not receive information about the other party. Furthermore, those who experientially learned about the other party’s perspective felt more positive about their relationships and made greater concessions during the negotiation than those who were simply provided information about the other party’s perspective. No differences were found between virtually and imaginatively taking the perspective of others. These findings suggest the importance of accounting for the type of social perspective taking in studying how this social-cognitive process may facilitate conflict resolution.

Background: Heart failure (HF) is associated with both mortality and a significant decline in health status. Interatrial shunting is increasingly being investigated as a novel therapeutic option., Objectives: The ALT FLOW Early Feasibility Study was designed to evaluate the safety of the Edwards left atrial to coronary sinus APTURE Transcatheter Shunt System in patients with symptomatic HF., Methods: A total of 18 centers enrolled patients with symptomatic HF with a pulmonary capillary wedge pressure >15 mm Hg at rest or 25 mm Hg during exercise., Results: Between May 2018 and September 2022, 87 patients underwent attempted APTURE shunt implantation. Mean age was 71 years, and 53% were male. At baseline, mean left ventricular ejection fraction was 59% with 90% of the patients being in NYHA functional class III. Device success was achieved in 78 patients (90%), with no device occlusions or associated adverse events identified after implantation. The primary safety outcome occurred in only 2 patients (2.3%) at 30 days. At 6 months, health status improved: 67% of participants achieved NYHA functional class I to II status, with a 23-point improvement (P < 0.0001; 95% CI: 17-29 points) in the Kansas City Cardiomyopathy Questionnaire overall summary score. Also at 6 months, 20-W exercise pulmonary capillary wedge pressure was 7 mm Hg lower (P < 0.0001; 95% CI: -11 to -4 mm Hg) without change in right atrial pressure or other right heart function indices., Conclusions: In this single-arm experience, the APTURE Transcatheter Shunt System in patients with symptomatic HF was observed to be safe and resulted in reduction in pulmonary capillary wedge pressure and clinically meaningful improvements in HF symptoms and quality of life indices., Competing Interests: Funding Support and Author Disclosures This study was funded by Edwards Lifesciences, who also directed the design and conduct of the study, the collection, analysis, and interpretation of the data with input from their lead investigators. Dr Hibbert has received institutional research support from Abbott, NXT, Edwards Lifesciences, Boston Scientific, and Occlutech. Dr Zahr is a consultant to Edwards Lifesciences and Medtronic; and has received research and educational grants from Edwards Lifesciences, Medtronic, and Siemens. Dr Simard is a consultant to Boston Scientific; and has received research support from Edwards Lifesciences. Dr Nazer is a consultant to Boston Scientific and Biosense Webster; and has received investigator-initiated research funding from Siemens and Galaxy Medical. Dr Sorajja has served on advisory boards for 4C Medical, Abbott Vascular Structural, Boston Scientific SHV Strategic Advisory Board, Medtronic Structural Advisory Board, and VDyne; and is a consultant to 4C Medical, Anteris, Abbott Structural, Boston Scientific, Edwards Lifesciences, Evolution Medical, Foldax, GLG, Medtronic, Phillips, Siemens, Shifamed, WL Gore, VDyne, and xDot. Dr Pineda is a consultant to Cardiovascular Systems, Inc. Dr Schwartz has been a consultant for Abbott Vascular Structural, Boston Scientific, Edwards Lifesciences, Medtronic, Philips, WL Gore, Cordis; serves on advisory boards for Medtronic, Boston Scientific, Edwards Lifesciences, and Cordis; and has received research funding from Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, Philips, WL Gore, and Cordis. Dr Wiley is a consultant to Edwards Lifesciences. Dr Sauer has received speaker or consulting honoraria from Edwards Lifesciences, Abbott, Boston Scientific, Biotronik, Medtronic, Bayer, General Prognostics, Impulse Dynamics, and Story Health. Dr Jorde is a consultant to Abbott, Edwards Lifesciences, and AncoraHeart. Dr Latib is a consultant for Edwards Lifesciences, Abbott Vascular, Medtronic, Boston Scientific, and Philips. Dr Kahwash is a consultant and serves on advisory boards for Medtronic, Cardionomic, and Impulsedynamics. Dr Gafoor is a consultant to Edwards Lifesciences, Abbott Lifesciences, and Boston Scientific. Dr Chaudhry has received speaker honoraria from Medtronic; and consultation fees from Edwards Lifesciences. Dr. Hermiller is a consultant to Edwards Lifesciences. Drs Aldaia and Koulogiannis are members of a cardiovascular core lab, for which they receive no direct compensation, that has agreements with Edwards Lifesciences, Abbott, Medtronic, and NXT Biomedical. Dr Koulogiannis is also a consultant to Edwards Lifesciences and Abbott; and serves on an advisory board for Edwards Lifesciences. Dr Gray is a consultant to Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: Our study reports the first-in-human experience of a novel approach for left atrial access via the coronary sinus-the percutaneous atriotomy-which is used for left atrial decompression with a dedicated left atrial (LA)-to-coronary sinus (CS) shunt., Background: Elevated LA pressures contribute to heart failure symptoms, and targeted therapy with atrial shunt devices for LA decompression is an emerging strategy. Current devices reside in the interatrial septum, with risk for right-to-left shunting and systemic embolization. Moreover, preservation of the interatrial septum is imperative with an increasing number of left-sided transseptal transcatheter interventions., Methods: Patients with symptomatic heart failure underwent implantation in a multicenter, international compassionate experience. Clinical, anatomic, and hemodynamic parameters were assessed at baseline and follow-up. The right internal jugular vein enabled CS cannulation, followed by CS-to-LA puncture and balloon dilation of the LA wall, completing the percutaneous atriotomy. The novel shunt device was then deployed between the left atrium and CS, enabling LA decompression., Results: Percutaneous atriotomy was attempted in 11 patients, with success in 8; of these, all shunt deployments were successful. In follow-up (median 201 days; interquartile range [IQR]: 156 to 260 days) there were no major periprocedural adverse events, New York Heart Association functional class improved to I or II in 87.5%, pulmonary capillary wedge pressure was reduced (Δ -9 mm Hg; IQR: -9.5 to -8 mm Hg), and shunting was sustained (Δ Qp/Qs 0.25; IQR: 0.19 to 0.33)., Conclusions: Our study reports the first-in-human experience of a novel approach for left-sided transcatheter cardiac interventions: the percutaneous atriotomy. This approach enabled the placement of a novel LA-to-CS shunt for LA decompression. The procedure is feasible and results in clinical and hemodynamic improvements., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to compare the clinical characteristics and long-term outcomes of patients with ST-segment elevation myocardial infarction (STEMI) with and without cardiogenic shock (CS) or cardiac arrest (CA) before percutaneous coronary intervention (PCI)., Background: Patients with STEMI complicated by CS or CA are underrepresented in STEMI registries., Methods: Consecutive patients with STEMI or new left bundle branch block within 24 h of symptom onset were included in a regional STEMI program comprising a PCI center (Minneapolis Heart Institute at Abbott Northwestern Hospital), 11 hospitals <60 miles from PCI center (zone 1), and 19 hospitals 60 to 210 miles from PCI center (zone 2). No patients were excluded. Patients were stratified based on the presence (+) or absence (-) of CS or CA before PCI. Patients with CA were further classified based on initial rhythm. Primary outcomes were in-hospital and 5-year mortality., Results: Between March 2003 and December 2014, 4,511 STEMI patients were included in the regional program, including 398 (9%) with CS and 499 (11%) with CA. Hospital mortality was: CS+ and CA+, 44%; CS+ and CA-, 23%; CS- and CA+, 19%; and CS- and CA-, 2% (p < 0.001). The 5-year survival probability for CS+ and CA+ patients was 0.69 (95% confidence interval: 0.61 to 0.76) and 0.89 (95% confidence interval: 0.84 to 0.93), respectively (p < 0.01). Compared with patients with shockable rhythms, CA patients with nonshockable rhythms had significantly lower odds of survival at hospital discharge and at 5 years (both p < 0.001)., Conclusions: The combination of CS and CA significantly increases short-term mortality in patients with STEMI. After 5 years of follow-up, CS patients remained at high risk of fatal events, whereas the prognosis of CA patients was determined by initial rhythm at presentation., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Long-term survivors after implantation of left ventricular assist devices (LVADs) are increasing in prevalence. We describe the characteristics and outcomes in patients surviving longer than 4 years on LVAD support., Methods: We performed a multicenter, retrospective analysis of patients surviving at least 4 years on continuous-flow LVAD (CF-LVAD) support with a HeartMate II at centers participating in the Evolving Mechanical support Research Group., Results: Between 2005 and 2010, 156 long-term survivors were identified with a mean survival of 7.1 years (95% confidence interval: 6.7 to 7.5 years). The mean age was 58.2 ± 15.2 years and 30.1% were women. Readmission rate was low at 1.1 events per patient per year with the most common reasons leading to readmission being infection (0.10 readmissions per patient per year) and gastrointestinal bleeding (0.07 readmissions per patient per year). Two years after implantation, 97% of patients were either New York Heart Association functional class I or II, with 92% at 4 years., Conclusions: Patients surviving 4 years on CF-LVAD support can anticipate ongoing long-term survival with sustained improvements in functionality and low rates of rehospitalization., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2018 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Aortic insufficiency (AI) is a significant long-term complication of continuous-flow left ventricular assist device (CF-LVAD) implantation. We sought to evaluate its impact on clinical outcomes and mortality in CF-LVAD recipients., Methods: We retrospectively analyzed 237 patients implanted with HeartMate II CF-LVADs at our institution from June 2005 through June 2013. We evaluated recipients' baseline characteristics and annual echocardiograms, grading AI severity as either none, trace, mild, moderate or severe. Only moderate or severe AI was considered clinically significant. Recipients who underwent concomitant aortic valve surgery or who had undergone previous prosthetic aortic valve implantation were excluded., Results: Moderate or severe AI occurred in 32 (15.2%) patients. Risk factors that significantly affected the development of AI included older age at the time of implantation, female gender, longer duration of LVAD support and destination therapy designation. Freedom from moderate or severe AI was 94%, 76% and 65% of patients at 1, 3 and 5 years, respectively. Overall cohort survival based on Kaplan-Meier analysis was 78%, 59% and 42% at 1, 3 and 5 years, respectively. There was no difference in survival between recipients who developed significant AI and those who did not (log-rank test, p = 0.73)., Conclusions: In this large, single-institution study, the overall rate of AI was low, but increased in frequency with longer duration of LVAD support. Although AI development remains a concern for patients on long-term CF-LVAD support, AI development does not appear to impact long-term mortality., (Copyright © 2016 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: High levels of discordance between activated partial thromboplastin time (aPTT) and anti-factor Xa (anti-FXa) have been reported in patients with continuous-flow left ventricular assist devices (CF-LVADs). We sought to determine the biochemical basis for discordance by simultaneous measurement of coagulation factors with aPTT and anti-FXa., Methods: Consecutive CF-LVAD patients admitted for intravenous unfractionated heparin (IV-UFH) therapy were studied. IV-UFH was monitored based on an anti-FXa. International normalized ratio (INR), aPTT, lactate dehydrogenase, and coagulation factors II, V, VII, VIII, IX, X, XI, and XII were measured simultaneously with anti-FXa., Results: The discordance rate between anti-FXa and aPTT was 74.7% overall (568 of 760 samples from 62 patients). In samples in which coagulation factors were simultaneously measured, the discordance rate was 66% (49 of 74 samples from 52 patients). In patients with INR ≤ 1.0 the discordance level was 31.8% vs 82.7% with INR > 1.8. No difference was observed in the rate of discordance between samples with low vs normal vitamin K-dependent factors (65.9% vs 64.7%, p = 0.99). Low factor XII was found in 15%; of these, 90.9% exhibited anti-FXa/aPTT discordance. Low factor V was found in 8.2%, and all were discordant. Factor VIII was elevated in 97% of samples, and 65.7% were discordant., Conclusions: In addition to the effects of warfarin administration on aPTT, the influence of other factors, such as low factor XII or V, may contribute to the discordance between aPTT values and anti-FXa. Coagulation factor levels may assist in individualization of anti-coagulation targets while patients implanted with CF-LVADs are on IV-UFH., (Copyright © 2016 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Left ventricular assist devices (LVADs) are increasingly used in patients with heart failure. To study the impact of stroke on clinical outcomes after continuous-flow (CF-) LVAD implantation, we evaluated our single-center experience., Methods: From 2006 to 2013, we implanted the HeartMate II CF-LVAD in 230 patients. We used standard statistical methods to evaluate our results., Results: Of our study group, 185 patients (80.4%) received the CF-LVAD as a bridge to transplantation. Strokes occurred in a total of 39 patients (17%), an incidence rate of 0.064 strokes per person-year: 19 (48.7%) were embolic, and 20 (51.3%) were hemorrhagic. The stroke-free rate at 6 months after HeartMate II implantation was 92.6%, at 12 months, 89.6%, and at 24 months, 86.1%. Baseline demographic characteristics did not differ significantly, except that stroke patients had a lower incidence of coronary artery disease (p = 0.004) and prior cardiac surgery (p = 0.001). We noted a trend toward an increased risk of stroke in patients with CF-LVAD-related infections (p = 0.053). The survival rate in stroke (versus stroke-free) patients at 6 months was 84.6% (versus 84.2%); at 12 months, 71.8% (versus 81.6%); and at 24 months, 53.9% (versus 74.7%; p = 0.0019). During a median follow-up time of 761 days, mortality risk in stroke patients was 2.01 times that of stroke-free patients (hazard ratio = 2.01; p = 0.004)., Conclusions: Stroke while on CF-LVAD support was associated with significant mortality. To reduce the risk of stroke, it is essential to further elucidate risk factors, to optimize anticoagulation, and to further understand the impact of LVAD-related infections., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: This study investigated the relationship between anti-factor Xa (anti-FXa) and activated partial thromboplastin time (aPTT) for monitoring intravenous unfractionated heparin (IV-UFH) in patients with continuous-flow left ventricular assist devices (CF-LVADs)., Background: CF-LVADs have become mainstream therapy for patients with advanced heart failure. Thromboembolic events, device thrombosis, and bleeding continue to be a challenge with this technology. Adequate anticoagulation is required to prevent these adverse events., Methods: A prospective study of consecutive patients implanted with a CF-LVAD was conducted. Paired samples were considered concordant if aPTT values fell into expected ranges for subtherapeutic, therapeutic, and supratherapeutic anti-FXa levels. Heparin dosing was on the basis of anti-Xa levels., Results: A total of 340 paired values from 38 patients were evaluated. Anti-FXa and aPTT were discordant in 253 samples (74.4%), with a high degree of variability in aPTT for any given anti-FXa level (r(2) = 0.57). Results were discordant in 104 samples (63.8%) from patients undergoing bridging therapy with warfarin and in 149 samples (84.2%) from patients with device obstruction and/or hemolysis (p < 0.001). The most common pattern of discordance was a supratherapeutic aPTT value despite a therapeutic anti-FXa level (49.1% for bridging vs. 75.8% for device obstruction and/or hemolysis; p < 0.001)., Conclusions: Levels of aPTT were disproportionately prolonged relative to the corresponding anti-FXa levels in CF-LVAD patients, particularly those with device obstruction. Hemolysis and warfarin administration may falsely elevate aPTT, resulting in overestimation of heparin concentration and under-anticoagulation. Use of aPTT and anti-FXa to guide heparin therapy may lead to different estimates of heparin concentration in the same patient., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study investigated whether continuous AI and/or elevated mean arterial pressure (MAP) were associated with false positive results for flow obstruction in echocardiographic ramp speed tests in patients with a continuous-flow left ventricular assist device., Background: Failure to reduce the left ventricular end-diastolic diameter (LVEDD) with increasing device speeds in a ramp test is predictive of pump obstruction. Aortic insufficiency (AI) or increased MAP can diminish the ability to unload the left ventricle., Methods: LVEDD was plotted against device speed, and a linear function slope was calculated. A flat LVEDD slope (≥-0.16) was considered abnormal (suggestive of obstruction). Ramp test results were compared in patients with or without either AI or increased MAP at baseline speed, and receiver-operator characteristic (ROC) curves were constructed for predictors of device obstruction. Device thrombosis was confirmed by direct visualization of clot at explantation or on inspection by the manufacturer., Results: Of 78 ramp tests (55 patients), 36 were abnormal (18 true positive, 18 false positive), and 42 were normal (37 true negative, 5 false negative). In patients with AI, LVEDD slope was -0.14 ± 0.17, which was consistent with device obstruction (vs. -0.25 ± 0.11 in patients without AI; p < 0.001), despite no difference in mean lactate dehydrogenase concentration between the 2 groups (1,301 ± 1,651 U/l vs. 1,354 ± 1,365 U/l; p = 0.91). Area under the ROC curve (AUC) for LVEDD slope was 0.76 and improved to 0.88 after removal of patients with AI from the study. LVEDD slope in patients with MAP ≥85 mm Hg was similar to that for device obstruction (-0.18 ± 0.07) and was abnormal in 6 of the 12 ramp tests performed. Combining LVEDD slope with lactate dehydrogenase concentration increased the AUC to 0.96 as an indicator of device obstruction., Conclusions: Abnormal loading conditions due to AI or elevated MAP may result in false positive ramp tests., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

A 63-year-old man with ischemic cardiomyopathy, ejection fraction of 15%, and status after HeartMate II implantation as a bridge to cardiac transplantation presented with presyncope and exertional dyspnea 1.5 years after implantation. After unrevealing laboratory workup and echocardiography for LVAD thrombosis, the patient underwent CT imaging. CT revealed mural thrombus in the proximal LVAD outflow cannula, a very unlikely site of thrombus, highlighting the importance of CT imaging in diagnosis of LVAD complications., (Copyright © 2014 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Background: Advanced heart failure teams are often faced with the decision of whether or not to offer a left ventricular assist device (LVAD) to patients who have end-stage heart failure and recent or ongoing substance abuse. The outcomes of these patients after LVAD implantation are unknown., Methods: Baseline predictors and outcomes were collected and analyzed from patients with active substance abuse and a cohort of patients without active substance abuse matched for age, INTERMACS profile and year of implantation. The primary outcome was all-cause mortality. Secondary outcomes included rates of listing for cardiac transplantation, transplantation and chronic drive-line infection., Results: The cohort consisted of 20 consecutive LVAD recipients with active substance abuse and 40 recipients without active substance abuse. During a median follow-up period of 2.3 years (IQR 1.4 to 3.6), the substance abuse group had 3.2 times the rate (hazard) of death compared with a matched cohort (HR 3.2, 95% CI 1.2 to 8.0, p < 0.05). Furthermore, the rate of listing for transplant was 69% lower (rate ratio 0.31, p < 0.0005), rate of cardiac transplant was 89% lower (rate ratio 0.11, p < 0.0005), and risk of chronic drive-line infection was 5.4 times higher (rate ratio 5.4, p < 0.0005) in the substance abuse group., Conclusions: Active substance abuse in patients who received an LVAD was associated with increased mortality and overall poor outcomes. Larger scale data will be needed to confirm these findings and to inform decision-making in this population., (Copyright © 2014 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: An ongoing challenge in the management of patients with heart failure who receive left ventricular assist devices (LVADs) is achieving optimal anticoagulation. Adverse prothrombotic events include hemolysis or pump thrombus (H/T) and neurologic events (NEs), and all limit the success of LVAD therapy. Our aim was to study the incidence and clinical outcomes associated with these events in a large single-center cohort., Methods: We retrospectively reviewed our prospectively collected database of all patients receiving a HeartMate II (Thoratec Corp, Pleasanton, CA) LVAD from 2005 to 2012. Demographic, clinical, and outcome data were analyzed using standard statistical methods. All adverse events were recorded., Results: Of 193 patients receiving LVADs, we identified 39 H/T events in 26 (13.4%) patients and 22 NEs in 19 (9.8%) patients. Seventy-four percent of events occurred in the last 3 years of the series, during which time 63% of implants were placed. Of patients with H/T, 8 (31% of those having H/T, 4.1% of total) had more than 1 event and 4 (15.4% of those having H/T, 2.1% of total) underwent pump exchanges. Five (23%) patients had NEs after H/T, and 6 (32%) died as a result of the NE. Of patients with H/T, 27% had preceding episodes of infection, 31% had an international normalized ratio (INR) of less than 1.5, 31% had an INR of 1.5 to 2, 15% had a history of clotting or were hypercoagulable, and 4% had anticoagulation intentionally withheld. Lactate dehydrogenase (LDH), plasma hemoglobin, INR, and platelet determinations were significantly different at the time of H/T compared with baseline values. The survival at 6 months (alive or having undergone transplantation) for those with a prothrombotic event compared with those without was 70% versus 75.2% (p = 0.5)., Conclusions: The incidence of H/T or NEs is significant and results in major morbidity after LVAD placement. Infection and suboptimal anticoagulation are associated with the majority of these events. Identification of patients at higher risk for hemolysis (ie, infection) may allow for modification of anticoagulation regimens to reduce these risks and improve clinical outcomes., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The HeartWare left ventricular assist device (HVAD, HeartWare Inc, Framingham, MA) is the first implantable centrifugal continuous-flow pump approved for use as a bridge to transplantation. An infrequent but serious adverse event of LVAD support is thrombus ingestion or formation in the pump. In this study, we analyze the incidence of pump thrombus, evaluate the comparative effectiveness of various treatment strategies, and examine factors pre-disposing to the development of pump thrombus., Methods: The analysis included 382 patients who underwent implantation of the HVAD as part of the HeartWare Bridge to Transplant (BTT) and subsequent Continued Access Protocol (CAP) trial. Descriptive statistics and group comparisons were generated to analyze baseline characteristics, incidence of pump thrombus, and treatment outcomes. A multivariate analysis was performed to assess significant risk factors for developing pump thrombus., Results: There were 34 pump thrombus events observed in 31 patients (8.1% of the cohort) for a rate of 0.08 events per patient-year. The incidence of pump thrombus did not differ between BTT and CAP. Medical management of pump thrombus was attempted in 30 cases, and was successful in 15 (50%). A total of 16 patients underwent pump exchange, and 2 underwent urgent transplantation. Five patients with a pump thrombus died after medical therapy failed, 4 of whom also underwent a pump exchange. Survival at 1 year in patients with and without a pump thrombus was 69.4% and 85.5%, respectively (p = 0.21). A multivariable analysis revealed that significant risk factors for pump thrombus included a mean arterial pressure > 90 mm Hg, aspirin dose ≤ 81 mg, international normalized ratio ≤ 2, and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile level of ≥ 3 at implant., Conclusions: Pump thrombus is a clinically important adverse event in patients receiving an HVAD, occurring at a rate of 0.08 events per patient-year. Significant risk factors for pump thrombosis include elevated blood pressure and sub-optimal anti-coagulation and anti-platelet therapies. This suggests that pump thrombus event rates could be reduced through careful adherence to patient management guidelines., (© 2013 International Society for Heart and Lung Transplantation Published by International Society for the Heart and Lung Transplantation All rights reserved.)

In the last few years, left ventricular assist devices (LVADs) have moved to the forefront in the management of patients with advanced heart failure. Pumps have gradually become smaller and more efficient and have clearly demonstrated survival benefits and improvement in functional status and quality of life in patients with advanced heart failure. Despite impressive advances in device technology, risk of severe complications remains, such as device thrombosis. A 62-year-old man who underwent HeartWare LVAD implantation as a bridge to cardiac transplant was admitted 18 days after device implantation with severe shortness of breath, fatigue and lethargy; he was found to have increased pump flows with high power demands and evidence of cardiogenic shock. An echocardiogram showed an echo density at the inflow cannula that was suggestive of thrombosis. Laboratory data showed evidence of hemolysis. He was treated successfully with intraventricular tissue plasminogen activator with rapid resolution of his symptoms and return of LVAD flow and power consumption to baseline. The patient was discharged with no complications or recurrence of thrombosis and received a successful transplant 1 month later., (Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Continuous-flow left ventricular assist devices (LVADs) such as the HeartMate II have become the therapy of choice in patients with end-stage heart failure. The aim of this study is to report the outcomes in patients receiving the HeartMate II LVAD at a single center and review the lessons learned from this experience., Methods: From June 2005 to June 2010, 130 consecutive patients received the HeartMate II LVAD. Of these, 102 were bridge-to-transplant (BTT), 17 destination therapy, and 11 exchanges for failed HeartMate XVE. This study focuses on the 102 BTT patients. The HeartMate II was approved by the US Food and Drug Administration (FDA) as BTT in April 2008 and 64 patients received this device as BTT since that date. We review our experience with the device as BTT and report on patient survival and adverse events as well as the impact of FDA approval on outcomes., Results: Overall, mean age was 52.6 ± 12.8 years; 26 (25.5%) were female. Disease etiology was ischemic in 58, nonischemic in 36, and other in 8. Overall, 30-day, 6-month, and 1-year survival for the BTT patients was 95.1%, 83.5%, and 78.8%, respectively. The 6-month survival in 38 patients in the clinical trial (pre-FDA) was 88.8% and was not statistically significant compared with the 76.2% 6-month survival in the 64 patients in the post-FDA approval period (p value = 0.1). Major adverse events among the 102 BTT patients included right ventricular failure in 5 (4.9%), LVAD driveline infections in 25 (24.5%), neurologic events in 10 (9.8%), and gastrointestinal bleeding in 18 (17.6%) patients. In addition, 1 patient (0.98%) had pump thrombus requiring device replacement., Conclusions: Despite significant morbidity, use of the HeartMate II LVAD as BTT provides excellent hemodynamic support and is associated with excellent survival and low mortality. In addition, there needs to be improvement and focused strategies in the areas of gastrointestinal bleeding, driveline infections, and adverse neurologic events for these devices to be able to provide a real long-term alternative to heart transplantation., (Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2010 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)