Quality Improvement in Anesthetic Management of Patients with Left Ventricular Assist Device Support Presenting for Non-Cardiac Surgery: A Single Center Experience.

With the growing number of left ventricular assist device (LVAD) recipients requiring non-cardiac surgery and the limited availability of cardiac anesthesiologists, our study reviewed non-cardiac surgeries in HeartMate III patients with LVAD at our institution. We focused on anesthesiologist roles, detailing patient characteristics, anesthetic management, and outcomes and identifying improvement opportunities in this specialized care setting. A retrospective chart review was conducted of all patients with LVAD who underwent non-cardiac surgery at our institution between 2017 and 2022. Patient demographics, surgical characteristics, anesthetic management, and 30-day mortality rates were also assessed. A total of 23 patients were identified, with 17 (73.9%) males and a median age of 61 [53.5, 67.5] years. Cardiac anesthesiologists were present in nine (39.1%) cases. Elective surgeries were more common (73.9%), with intermediate-risk surgeries accounting for 52.2% of all surgeries. General anesthesia was administered to 18 patients (78.3%), with a median duration of 40 [24, 63.5] min. A single patient required reoperation because of bleeding, and two patients (8.7%) experienced 30-day mortality. Despite guidelines lacking detail, involving non-cardiac anesthesiologists in certain cases is essential. Sharing our experience aims to enhance the evolving discourse on non-cardiac surgeries for patients with LVAD, improving their outcomes and safety.

Phase II Study of Eribulin plus Pembrolizumab in Metastatic Soft-tissue Sarcomas: Clinical Outcomes and Biological Correlates.

PURPOSE: Eribulin modulates the tumor-immune microenvironment via cGAS-STING signaling in preclinical models. This non-randomized phase II trial evaluated the combination of eribulin and pembrolizumab in patients with soft-tissue sarcomas (STS). PATIENTS AND METHODS: Patients enrolled in one of three cohorts: leiomyosarcoma (LMS), liposarcomas (LPS), or other STS that may benefit from PD-1 inhibitors, including undifferentiated pleomorphic sarcoma (UPS). Eribulin was administered at 1.4 mg/m2 i.v. (days 1 and 8) with fixed-dose pembrolizumab 200 mg i.v. (day 1) of each 21-day cycle, until progression, unacceptable toxicity, or completion of 2 years of treatment. The primary endpoint was the 12-week progression-free survival rate (PFS-12) in each cohort. Secondary endpoints included the objective response rate, median PFS, safety profile, and overall survival (OS). Pretreatment and on-treatment blood specimens were evaluated in patients who achieved durable disease control (DDC) or progression within 12 weeks [early progression (EP)]. Multiplexed immunofluorescence was performed on archival LPS samples from patients with DDC or EP. RESULTS: Fifty-seven patients enrolled (LMS, n = 19; LPS, n = 20; UPS/Other, n = 18). The PFS-12 was 36.8% (90% confidence interval: 22.5-60.4) for LMS, 69.6% (54.5-89.0) for LPS, and 52.6% (36.8-75.3) for UPS/Other cohorts. All 3 patients in the UPS/Other cohort with angiosarcoma achieved RECIST responses. Toxicity was manageable. Higher IFNα and IL4 serum levels were associated with clinical benefit. Immune aggregates expressing PD-1 and PD-L1 were observed in a patient that completed 2 years of treatment. CONCLUSIONS: The combination of eribulin and pembrolizumab demonstrated promising activity in LPS and angiosarcoma.

Concurrent inhibition of CDK2 adds to the anti-tumour activity of CDK4/6 inhibition in GIST.

BACKGROUND: Advanced gastrointestinal stromal tumour (GIST) is characterised by genomic perturbations of key cell cycle regulators. Oncogenic activation of CDK4/6 results in RB1 inactivation and cell cycle progression. Given that single-agent CDK4/6 inhibitor therapy failed to show clinical activity in advanced GIST, we evaluated strategies for maximising response to therapeutic CDK4/6 inhibition. METHODS: Targeted next-generation sequencing and multiplexed protein imaging were used to detect cell cycle regulator aberrations in GIST clinical samples. The impact of inhibitors of CDK2, CDK4 and CDK2/4/6 was determined through cell proliferation and protein detection assays. CDK-inhibitor resistance mechanisms were characterised in GIST cell lines after long-term exposure. RESULTS: We identify recurrent genomic aberrations in cell cycle regulators causing co-activation of the CDK2 and CDK4/6 pathways in clinical GIST samples. Therapeutic co-targeting of CDK2 and CDK4/6 is synergistic in GIST cell lines with intact RB1, through inhibition of RB1 hyperphosphorylation and cell proliferation. Moreover, RB1 inactivation and a novel oncogenic cyclin D1 resulting from an intragenic rearrangement (CCND1::chr11.g:70025223) are mechanisms of acquired CDK-inhibitor resistance in GIST. CONCLUSIONS: These studies establish the biological rationale for CDK2 and CDK4/6 co-inhibition as a therapeutic strategy in patients with advanced GIST, including metastatic GIST progressing on tyrosine kinase inhibitors.

Continuous-Flow Left Ventricular Assist Device Therapy in Adults with Transposition of the Great Vessels.

An increasing number of children with congenital heart disease are surviving into adulthood and subsequently developing end-stage heart failure. Two example populations are adults who have been previously operated on for congenitally corrected transposition of the great arteries (CCTGA) and transposition of the great arteries (TGA). Implantation of a continuous flow left ventricular assist device (CF-LVAD) in these patients can present unusual anatomical and physiologic challenges. In this report, we describe outcomes of CF-LVAD implantation in three such patients. These cases demonstrate the feasibility of implanting a CF-LVAD in patients who have undergone surgery for CCTGA and/or TGA.

Left Ventricular Recovery with Explantation of Continuous-Flow Left Ventricular Assist Device after 5 Years of Support.

Mechanical circulatory support may result in sufficient myocardial recovery to allow for explantation of the left ventricular assist device (LVAD). The duration of support associated with left ventricular recovery has generally been 6-12 months. In this report, we present a patient in whom the left ventricle recovered after 5 years of support with a LVAD. Our report demonstrates that long-term monitoring for left ventricular recovery is prudent and may allow for late device explantation.

Primary intra-abdominal melanoma arising in association with extracutaneous blue naevus: a report of two cases.

AIMS: Blue naevi are uncommon dermal melanocytic neoplasms characterised by GNAQ/GNA11 mutations, which very rarely progress to melanoma. Such melanomas also often have BAP1 mutations, and lack genetic events associated with conventional melanoma. Exceptionally, blue naevi arise in extracutaneous locations; one melanoma arising in this setting has been reported. We report the clinicopathological, immunohistochemical and molecular genetic features of two cases of melanoma arising in extracutaneous blue naevus. METHODS AND RESULTS: Both arose in males, aged 25 and 63 years, with no history of other melanocytic lesions, and presented as large, painful intra-abdominal masses. The tumours were dark-brown/black, multilobulated, involved small intestinal mesentery and consisted of a predominantly fascicular and spindled, but occasionally nested and epithelioid, proliferation of variably pigmented, relatively monotonous cells with pale cytoplasm and ovoid nuclei with mild to moderate atypia. Mitotic activity was variable but generally low. Both cases showed areas of conventional and cellular blue naevus. Recurrent tumour in one case showed predominantly epithelioid morphology and greater cytological atypia and mitotic activity. One case expressed Melan-A, SOX10 and CD117, with absent expression of S100 protein and DOG1; the other expressed Melan-A, HMB45 and S100 protein. Next-generation sequencing identified GNAQ and BAP1 mutations in one case and GNA11 mutation in the other. Both patients developed widespread metastatic disease. CONCLUSION: Exceptionally rare, aggressive melanomas arising in extracutaneous blue naevi should be distinguished from metastatic melanoma, gastrointestinal stromal tumour and malignant melanotic nerve sheath tumour, especially given the significant therapeutic and prognostic differences between these different entities.

Sternum-Sparing HVAD Implantation with Attachment of the Outflow Graft to the Descending Aorta.

The standard approach for implanting an HVAD left ventricular assist device (LVAD) is performing a median sternotomy and sewing the outflow graft to the ascending aorta. However, in patients with sternal comorbidities, it may be advantageous to use a sternum-sparing approach. We retrospectively studied eight patients who underwent HVAD implantation for destination therapy via a left subcostal or fifth/sixth intercostal space incision. With this procedure, the outflow graft was sewed to the descending aorta. Ninety-day and one-year survival rates were 87.5% and 75%, respectively. Two patients (25%) died during the perioperative period: one from multisystem organ failure and the other from unrelated causes. We adjusted the HVAD speed to open the aortic valve once every three to four beats. Compared with other continuous-flow LVAD implantations performed at our institution during the study period (n = 437), this technique resulted in shorter bypass times and a lower incidence of infection; it was not associated with an increased incidence of heart failure, aortic root thrombosis, pump thrombosis, progression of aortic insufficiency, or ischemic neurologic dysfunction. Our findings suggest that a sternum-sparing approach for HVAD implantation is feasible and may be a safe option in patients with serious comorbidities that preclude the use of traditional implantation techniques.

Effect of cardiac arrest with aortic cross-clamping during left ventricular assist device implantation.

OBJECTIVES: Some patients who undergo continuous-flow left ventricular assist device (CF-LVAD) implantation require concomitant procedures that can be performed with or without cardiac arrest under aortic cross-clamping (AXC). Procedures normally performed with cardiac arrest are sometimes avoided or performed without cardiac arrest because it may be detrimental to right heart function. However, the effects of cardiac arrest on patients with advanced heart failure necessitating CF-LVAD support have not been thoroughly studied. We examined our single-centre experience to determine whether cardiac arrest during CF-LVAD implantation was associated with worse patient outcomes. METHODS: From November 2003 to March 2016, a total of 526 patients with chronic end-stage heart failure underwent primary CF-LVAD implantation. Preoperative demographics, postoperative complications and mortality rates were compared between patients who required cardiac arrest with AXC (n = 50) and those who did not (n = 476). RESULTS: The most frequently performed procedure requiring AXC was aortic valve closure (n = 23, 26.1%). Although the AXC group had longer cardiopulmonary bypass times (P < 0.01), long-term (5-year) survival was similar in AXC and non-AXC patients (P = 0.13). Also, postoperative right heart failure (P = 0.15) and neurological dysfunction (P = 0.89) rates were not significantly different between the 2 groups. Cox proportional hazards analysis showed that cardiac arrest with AXC was not an independent predictor of mortality (hazard ratio, 0.89; P = 0.73). CONCLUSIONS: Cardiac arrest with AXC during CF-LVAD implantation did not negatively affect long-term survival or the incidence of right ventricular failure or stroke. These findings should be considered in deciding surgical strategies. Additional investigation may be warranted to further understand the effects of cardiac arrest during LVAD implantation.

Accuracy of Postoperative Risk Scores for Survival Prediction in Interagency Registry for Mechanically Assisted Circulatory Support Profile 1 Continuous-Flow Left Ventricular Assist Device Recipients.

In this study, we sought to determine the accuracy of several critical care risk scores for predicting survival of Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profile 1 patients after continuous-flow left ventricular assist device (CF-LVAD) placement. We retrospectively analyzed the records of 605 patients who underwent CF-LVAD implantation between 2003 and 2016. We calculated the preoperative HeartMate II Risk Score (HMRS) and preoperative Right Ventricular Failure Risk Score (RVFRS) and the following risk scores for postoperative days 1-5: HMRS, RVFRS, Model for End-stage Liver Disease (MELD), MELD-eXcluding International Normalized Ratio, Post Cardiac Surgery (POCAS) risk score, Sequential Organ Failure Assessment (SOFA) risk score, and Acute Physiology and Chronic Health Evaluation III. The preoperative scores and the postoperative day 1, 5-day mean, and 5-day maximum scores were entered into a receiver operating characteristic curve analysis to examine accuracy for predicting 30-day, 90-day, and 1-year survival. The mean POCAS score was the best predictor of 30-day and 90-day survival (area under the curve [AUC] = 0.869 and 0.816). The postoperative mean RVFRS was the best predictor of 1-year survival (AUC = 0.7908). The postoperative maximum and mean RVFRS and HMRS were more accurate than the preoperative scores. Both of these risk score measurements of acuity in the postoperative intensive care unit setting help predict early mortality after LVAD implantation.

Gastrointestinal Bleeding After HeartMate II or HVAD Implantation: Incidence, Location, Etiology, and Effect on Survival.

The number of patients on destination therapy is increasing as long-term survival on continuous-flow left ventricular assist device (CF-LVAD) therapy has improved. Gastrointestinal bleeding (GIB) is a common complication after CF-LVAD implantation, and its risk correlates with longer support time, emphasizing the importance of GIB management. The lower pulsatility of CF-LVADs may promote arteriovenous malformations, which amplify the bleeding risk. Here, we retrospectively analyzed the location, incidence, and survival effect of GIB events in HeartMate II (HM-II) and HeartWare Ventricular Assist Device (HVAD) recipients to provide specific details regarding these complications. From November 2003 to March 2016, 526 patients with chronic heart failure underwent primary implantation of an HM-II (n = 403) or HVAD (n = 123) CF-LVAD at our center. Of the 526 patients, 140 (26.6%) had a GIB event (HM-II: n = 100; HVAD: n = 40), 92 (17.5%) had a single GIB event, and 48 (9.1%) had multiple GIB events (range: 2-9 events). HVAD recipients had a higher incidence of both upper and lower GIB events (p < 0.001 and P = 0.002, respectively) than HM-II recipients. Arteriovenous malformation was the most common etiology for GIB (50 patients/72 events); for this group, the average time-to-event was 300.4 days, the recurrence rate was 34%, and the 90-day and 1-year survival rates were 88.3% and 66.7%, respectively. Age at implantation was the only predictor of GIB. In conclusion, our study provides detailed information about GIB events associated with current CF-LVADs. Additional studies are required to evaluate strategies to reduce the incidence of GIB morbidity.

Outcomes of Repeat Left Ventricular Assist Device Exchange.

Implantable continuous-flow left ventricular assist devices (CF-LVADs) are used for long-term LV support in bridging patients to heart transplantation or as destination therapy. With prolonged support times, some patients will have repeat complications necessitating multiple device exchanges. To elucidate the safety and efficacy of repeat device exchange, we retrospectively reviewed data from 25 patients who underwent two or more CF-LVAD implantations between July 2005 and August 2017. Indications for exchange were thrombus/hemolysis (n = 8, 32%), electromechanical device malfunction (n = 14, 56%), and infection (n = 3, 12%). The implanted devices were the HeartMate II (n = 13, 52%), the HeartWare HVAD (n = 11, 44%), and the Jarvik 2000 (n = 1, 4%). Average hospital length of stay was 44 days (range 4-221 days), and 17 patients (68%) survived to discharge. Average duration of support after the most recent LVAD implantation was 802 days (range 1-3,229 days). Overall survival was 72% at 1 year and 60% at 2 years. Postoperative complications included respiratory failure in five patients (20%), device infection in five (20%), bleeding requiring reoperation in four (16%), neurologic dysfunction in four (16%), and acute renal failure in two (8%). Overall, our data suggest that repeat LVAD exchange is a feasible option for patients with recurrent device-related complications.

Plasmapheresis in Patients With Heparin-induced Thrombocytopenia Requiring Ventricular Assist Device.

Anticoagulation with unfractionated heparin is vital to reduce the risk of thromboembolic events during cardiopulmonary bypass and left ventricular assist device placement. However patients with heparin-induced thrombocytopenia are at risk of developing immune-mediated thrombotic events. We describe 2 patients with heparin-induced thrombocytopenia confirmed via serotonin release assay who were successfully treated with plasmapheresis exchange before left ventricular assist device placement.

Device exchange from Heartmate II to HeartWare HVAD.

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

Phase I Study of Rapid Alternation of Sunitinib and Regorafenib for the Treatment of Tyrosine Kinase Inhibitor Refractory Gastrointestinal Stromal Tumors.

PURPOSE: Polyclonal emergence of KIT secondary mutations is a main mechanism of imatinib progression in gastrointestinal stromal tumor (GIST). Approved KIT inhibitors sunitinib and regorafenib have complementary activity against KIT resistance mutations. Preclinical evidence suggests that rapid alternation of sunitinib and regorafenib broadens the spectrum of imatinib-resistant subclones targeted. PATIENTS AND METHODS: Phase Ib study investigating continuous treatment with cycles of sunitinib (3 days) followed by regorafenib (4 days) in patients with tyrosine kinase inhibitor (TKI)-refractory GIST. A 3+3 dosing schema was utilized to determine the recommended phase II dose (RP2D). Plasma samples were analyzed for pharmacokinetics and circulating tumor DNA (ctDNA) studies using targeted error correction sequencing (TEC-seq) and droplet digital PCR (ddPCR). RESULTS: Of the 14 patients enrolled, 2 experienced dose-limiting toxicities at dose level 2 (asymptomatic grade 3 hypophosphatemia). Sunitinib 37.5 mg/day and regorafenib 120 mg/day was the RP2D. Treatment was well-tolerated and no unexpected toxicities resulted from the combination. Stable disease was the best response in 4 patients, and median progression-free survival was 1.9 months. Combined assessment of ctDNA with TEC-seq and ddPCR detected plasma mutations in 11 of 12 patients (92%). ctDNA studies showed that KIT secondary mutations remain the main mechanism of resistance in TKI-refractory GIST, revealing effective suppression of KIT-mutant subpopulations in patients benefiting from the combination. CONCLUSIONS: Sunitinib and regorafenib combination is feasible and tolerable. Rapid alternation of TKIs with complementary activity might be effective when combining drugs with favorable pharmacokinetics, potentially allowing active doses while minimizing adverse events. Serial monitoring with ctDNA may guide treatment in patients with GIST.

Acute Kidney Injury With Ventricular Assist Device Placement: National Estimates of Trends and Outcomes.

RATIONALE & OBJECTIVE: Ventricular assist devices (VADs) are used for end-stage heart failure not amenable to medical therapy. Acute kidney injury (AKI) in this setting is common due to heart failure decompensation, surgical stress, and other factors. Little is known about national trends in AKI diagnosis and AKI requiring dialysis (AKI-D) and associated outcomes with VAD implantation. We investigated national estimates and trends for diagnosed AKI, AKI-D, and associated patient and resource utilization outcomes in hospitalizations in which implantable VADs were placed. STUDY DESIGN: Cohort study of 20% stratified sample of US hospitalizations. SETTING & PARTICIPANTS: Patients who underwent implantable VAD placement in 2006 to 2015. EXPOSURE: No AKI diagnosis, AKI without dialysis, AKI-D. OUTCOMES: In-hospital mortality, length of stay, estimated hospitalization costs. ANALYTICAL APPROACH: Multivariate logistic and linear regression using survey design methods to account for stratification, clustering, and weighting. RESULTS: An estimated 24,140 implantable VADs were placed, increasing from 853 in 2006 to 3,945 in 2015. AKI was diagnosed in 56.1% of hospitalizations and AKI-D occurred in 6.5%. AKI diagnosis increased from 44.0% in 2006 to 2007 to 61.7% in 2014 to 2015; AKI-D declined from 9.3% in 2006 to 2007 to 5.2% in 2014 to 2015. Mortality declined in all AKI categories but this varied by category: those with AKI-D had the smallest decline. Adjusted hospitalization costs were 19.1% higher in those with diagnosed AKI and 39.6% higher in those with AKI-D, compared to no AKI. LIMITATIONS: Administrative data; timing of AKI with respect to VAD implantation cannot be determined; limited pre-existing chronic kidney disease ascertainment; discharge weights not derived for subpopulation of interest. CONCLUSIONS: A decreasing proportion of patients undergoing VAD implantation experience AKI-D, but mortality among these patients remains high. AKI diagnosis with VAD implantation is increasing, possibly reflecting changes in AKI surveillance, awareness, and coding.

Donation After Cardiac Death: A Necessary Expansion for Heart Transplantation.

The gold standard and sole curative therapy for advanced stage heart failure is cardiac transplantation. As the population ages, the number of patients diagnosed with advanced heart failure and listed for transplant steadily increases annually. However, there remains a paucity of eligible donation after brain death (DBD) donor hearts which severely limits access to cardiac transplantation and leads to increasing wait-list times and avoidable patient mortalities. Though the first human heart transplant in 1967 was performed using a deceased donor heart, the advent of brain death criteria and the ability to avoid long warm ischemic times led donation after cardiac death (DCD) transplantation to fall out of favor. Due the current state of cardiac transplantation, there has been a resurgence in interest in DCD heart transplantation leading to the development of DCD heart transplantation programs in the UK and Australia after positive reports of successful DCD cardiac transplantation in the pediatric literature. These programs have demonstrated favorable post-transplantation outcomes equivalent to matched traditional DBD transplants with current techniques and strict donor criteria. This technique has been proven safe with favorable outcomes and has been demonstrated to significantly increase transplant volumes and decrease patient mortality. Given these outcomes and the high patient benefit to risk ratio, DCD donor heart transplantation is necessary to expand the donor pool and decrease patient mortality and should be developed in high volume experienced cardiac transplant centers.

Concomitant valve procedures in patients undergoing continuous-flow left ventricular assist device implantation: A single-center experience.

OBJECTIVE: Long-term support with continuous-flow left ventricular assist devices (CF-LVADs) has improved the outcomes of patients with end-stage heart failure. However, valve disease management in patients who undergo CF-LVAD implantation remains controversial. The aim of this study was to assess our single-center experience with patients who underwent a concomitant valve procedure during implantation of a CF-LVAD. METHODS: From November 2003 through March 2016, 526 patients underwent primary CF-LVAD implantation with a HeartMate II (St Jude Inc, St Paul, Minn; n = 403) or HeartWare (Medtronic, Minneapolis, Minn; n = 123) device at our center. Of those, 91 underwent a concomitant valve procedure during implantation (CF-LVAD+valve procedure group), whereas 435 did not (CF-LVAD-only group). We compared preoperative characteristics and short-term and mid-term survival rates between these groups. RESULTS: The concomitant valve procedures performed included 13 tricuspid valve repairs, 19 aortic valve repairs or replacements, 30 mitral valve repairs or replacements, and 29 double valve repairs or replacements. Survival rates at 1 month, 6 months, 12 months, and 24 months were 90.3%, 81.4%, 74.9%, and 67.4%, respectively, for the CF-LVAD-only group and 89.0%, 75.8%, 70.3%, and 65.9%, respectively, for the CF-LVAD+valve procedure group (P = .55). The results of Cox regression multivariable modeling showed that performing a concomitant valve procedure was not an independent predictor of mortality (hazard ratio, 1.29; 95% confidence interval, 0.96-1.74; P = .08). CONCLUSIONS: In our experience, performing a concomitant valve procedure during CF-LVAD implantation was not associated with an increased mortality rate. The decision to perform a concomitant valve procedure should be made primarily on the basis of clinical indications for the procedure.

Severe LVAD-related infections requiring surgical treatment: Incidence, predictors, effect on survival, and impact of device selection.

BACKGROUND: Left ventricular assist devices (LVADs) are being used more frequently for treating refractory, advanced heart failure. However, infection remains a frequent complication. In this study, we analyzed the incidence of severe infections in LVAD recipients to determine its impact on survival. METHODS: From May 2009 through March 2016, 437 patients with advanced heart failure underwent implantation of a continuous-flow LVAD (n = 314, HeartMate II LVAD [Abbott Laboratories, Abbott Park, IL]; n = 123 HeartWare HVAD [Medtronic, Minneapolis, MN]). We analyzed the rate of severe device infection requiring surgical intervention or involving sepsis and the impact of severe infection on outcomes in patients on long-term LVAD support. RESULTS: Infection occurred in 244 patients (HeartMate II, n = 186; HVAD, n = 58); severe infections developed in 160 patients (HeartMate II, n = 119; HVAD, n = 41). HeartMate II recipients had 344 severe infection events (0.63 events per patient-year [EPPY]), whereas HeartWare recipients had 89 severe infection events (0.42 EPPY; P = 0.047). HeartMate II recipients had a higher incidence of pump infections (P < 0.001). Severe infections did not significantly affect survival (P = 0.42). CONCLUSIONS: Although HeartMate II patients had a significantly higher incidence of pump infections requiring surgical treatment, survival was not adversely affected. The difference in postoperative infection rates may be an important factor in device type selection.

A left ventricular end-diastolic dimension less than 6.0 cm is associated with mortality after implantation of an axial-flow pump.

OBJECTIVE: The effects of having a lower left ventricular end-diastolic dimension before HeartMate II (Thoratec Corp, Pleasanton, Calif) left ventricular assist device implantation remain unclear. We analyzed our single-center data on HeartMate II implantation to determine whether having a lower left ventricular end-diastolic dimension preoperatively was associated with inferior outcomes. METHODS: From November 2003 to March 2016, 393 patients with chronic heart failure underwent primary HeartMate II implantation. We compared the preoperative left ventricular end-diastolic dimension and associated survival outcomes of these patients to determine the left ventricular end-diastolic dimension cutoff for worse overall survival. Then, we compared the preoperative demographics, stroke rate, and mortality of patients with a left ventricular end-diastolic dimension above the cutoff for worse survival with those of patients with a left ventricular end-diastolic dimension below the cutoff. RESULTS: A Cox multivariate regression model showed that low left ventricular end-diastolic dimension was an independent predictor of mortality (hazard ratio, 1.49; P = .02). The Contal and O'Quigley method showed that overall survival postimplantation was decreased in patients with a left ventricular end-diastolic dimension less than 6.0 cm (n = 91). Kaplan-Meier analysis confirmed that the left ventricular end-diastolic dimension less than 6.0 cm group had lower overall survival than the left ventricular end-diastolic dimension 6.0 cm or greater group (P = .04). Furthermore, a competing-risk analysis showed that postoperative stroke was more common in the left ventricular end-diastolic dimension less than 6.0 cm group than in the left ventricular end-diastolic dimension 6.0 cm or greater group (P < .01). CONCLUSIONS: Overall survival was decreased and postoperative stroke was increased in HeartMate II recipients with a preoperative left ventricular end-diastolic dimension less than 6.0 cm. Future research should determine the left ventricular end-diastolic dimension cutoff values for safely implanting other support devices, and device designs should be improved to better accommodate the needs of patients with a limited left ventricle size.