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Background Appropriate collection of quality of life (QOL) measurements for left ventricular assist device (LVAD) patients is challenging. Patient-Reported Outcomes Measurement Information System (PROMIS) is a popular tool that has been validated across multiple disciplines, but its applicability to the LVAD population remains unknown. Methods This single-center, retrospective review included LVAD patients that completed a PROMIS assessment and Kansas City Cardiomyopathy Questionnaire (KCCQ-12) survey at clinical encounters postoperatively. Patients completed computer adaptive PROMIS assessments for physical function, pain interference and depression. All PROMIS domains are designed to follow a normal distribution (mean T-score 50, standard deviation 10) in the general population. Assessments were aggregated over time and correlation between the KCCQ-12 summary score and each PROMIS domain was assessed individually. Results A total of 178 LVAD patients were included in the study. The median time between LVAD implantation and PRO collection was 16.5 [interquartile range, 7.9-37.8] months. Patients typically had worse physical function (T-score 38.8 [33.6-44.2]) but comparable pain (51.1 [38.7-59.2]) and depression (49.9 [41.7-57.5]) as the general population. The KCCQ-12 was more strongly correlated to PROMIS physical function (Spearman’s ρ = 0.746) than pain (ρ = -0.539) or depression (ρ = -0.591). Conclusions PROMIS provides a robust QOL data collection system that can be implemented in a clinical setting without imposing a significant burden. Using this more holistic system may allow for better patient-centered care in order to address QOL limitations imposed by LVAD support that are not directly related to heart failure symptoms.

Background Historically, obesity was considered a relative contraindication to left ventricular assist device (LVAD) implantation with less invasive surgery (LIS). The present study aimed to compare the outcomes of obese patients who underwent LVAD implantation through LIS with those who received full sternotomy (FS) implantation. Methods We retrospectively reviewed all patients implanted with HeartMate 3 LVAD in our institution between September 2015 and June 2020. Obese patients (BMI ≥ 30 kg/m2 ) were included and dichotomized based on surgical approach into the FS or LIS cohort. Results Of 231 implanted patients, 107 (46%) were obese and included in the study. FS was performed in 26 (24%) patients and LIS approach in 81 (76%) patients. Preoperative patient characteristics were similar between the cohorts. Postoperatively, patients in LIS cohort had less bleeding (p = 0.029), fewer transfusions (p = 0.042), shorter duration of inotropic support ( p = 0.049), and decreased incidence of severe RV failure (11.1% vs 30.8%, p = 0.028). Survival to discharge for the obese population was 87.5% overall and did not differ based on an approach (91.4% LIS vs 76.9% FS, p = 0.079). More LIS patients were discharged home (60.0% vs 82.4%, p = 0.041) rather than to rehabilitation center . Conclusion Our results showed that the LIS approach in obese patients is associated with fewer postoperative complications and a trend towards better short-term survival. These results suggest that less invasive LVAD implantation is a safe and effective approach for obese patients. Future prospective randomized trials are required to substantiate these results.

Background Venoarterial (VA) extracorporeal membrane oxygenation (ECMO) undoubtedly saves many lives, but it is associated with a high degree of patient morbidity, mortality, and resource use. This study aimed to develop a machine learning algorithm to augment clinical decision making related to VA-ECMO. Methods Patients supported by VA-ECMO at a single institution from May 2011 to October 2018 were retrospectively reviewed. Laboratory values from only the initial 48 hours of VA-ECMO support were used. Data were split into 70% for training, 15% for validation, and 15% withheld for testing. Feature importance was estimated, and dimensionality reduction techniques were used. A deep neural network was trained to predict survival to discharge, and the final model was assessed using the independent testing cohort. Model performance was compared with that of the SAVE (Survival After Veno-arterial ECMO) score by using a receiver operator characteristic curve. Results Of the 282 eligible adult patients who were undergoing VA-ECMO, 117 (41%) survived to discharge. A total of 1.96 million laboratory values were extracted from the electronic medical record, from which 270 different summary variables were derived for each patient. The most important variables in predicting the primary outcome included lactate, age, total bilirubin, and creatinine. For the testing cohort, the final model achieved 82% overall accuracy and a greater area under the curve than the SAVE score (0.92 vs 0.65; P = .01) in predicting survival to discharge. Conclusions This proof of concept study demonstrates the potential for machine learning models to augment clinical decision making for patients undergoing VA-ECMO. Further development with multi-institutional data is warranted.

Background Despite limited evidence, systemic anticoagulation is the current standard of care for patients supported on venoarterial-extracorporeal membrane oxygenation (VA-ECMO). We hypothesized that not anticoagulating patients on VA-ECMO would decrease complications. Methods We retrospectively reviewed adult patients supported on VA-ECMO at our institution. Patients were stratified based on anticoagulation strategy. The primary outcome was a composite of hemorrhagic and thrombotic complications. Secondary outcomes included blood product use, incidence of heparin-induced thrombocytopenia (HIT), hospital length of stay, and in-hospital mortality. Results From May 2011 through January 2018, there were 203 eligible patients supported on VA-ECMO, 35% (75 patients) were not anticoagulated. Overall complication rates were significantly lower for the no anticoagulation group (57% versus 76%; P = .007) including a trend toward fewer hemorrhagic complications (53% versus 63%; P = .178) without increased risk of thrombosis (13% versus 21%; P = .147). The anticoagulated group required more transfusions of packed red blood cells (12.8 versus 1.09; P = .002) and platelets (3.0 versus 1.3; P = .009) and showed a higher incidence of HIT (8% versus 0%; P = .015). No difference was found in overall mortality (72% versus 62%; P = .165). Conclusions The absence of routine systemic anticoagulation for patients supported on VA-ECMO is not associated with higher mortality, pump failure, or thrombotic complications. Patients had a lower requirement for blood product transfusions, and there was no incidence of HIT. Patients supported on VA-ECMO without other indications for anticoagulation can be treated without systemic anticoagulation during their VA-ECMO course.

BACKGROUND Left ventricular assist devices (LVADs) have improved outcomes for selected patients with advanced heart failure, but alternative optimal surgical techniques remain to be defined. We aim to describe our initial experience in using a sternal-sparing (SS) technique for implantation of a magnetically levitated LVAD, the HeartMate 3 (HM3) pump. METHODS This retrospective, single-center study included consecutive patients implanted with the HM3 LVAD between September 2015 and September 2018. Patients were compared based on surgical approach: SS or traditional sternotomy (TS). The primary outcome was overall survival at 6 months. Secondary outcomes included peri-operative complications, blood product utilization, and hospital readmissions. RESULTS Of 105 patients implanted with the HM3 LVAD, 41 (39%) were implanted via SS and 64 (61%) via TS approach. There were no intraoperative conversions. The SS patients were younger; otherwise, all other characteristics were similar between cohorts. The SS cohort demonstrated a significantly lower incidence of severe right ventricular failure (7% vs 28%, p = 0.012), fewer blood-product transfusions (41% vs 86%, p < 0.001), and shorter index hospital length of stay (15.5 vs 21 days, p = 0.018). Six-month survival was 93% for the SS cohort. CONCLUSIONS In this single-center observational study, we have demonstrated that the SS approach may be a safe and effective surgical technique for implantation of the HM3 LVAD in well-selected patients. The potential benefits compared with TS require further inquiry.

Background Left ventricular assist device (LVAD) therapy has been the standard of care for selected patients with advance heart failure. Even though considerable strides have been achieved with the introduction of the newest centrifugal pump, therapy is still burdened with significant perioperative complications. Smaller devices, along with improved techniques and instruments, have encouraged the adoption of minimally invasive cardiac surgery (MICS) techniques for LVAD implantation to improve perioperative outcomes. Methods We describe a technique for complete sternal-sparing (CSS) HeartMate 3 (Abbott Laboratories, Abbott Park, IL) left ventricular assist device (LVAD) implantation using bilateral thoracotomies and discuss early clinical outcomes of the first ten consecutive patients who underwent CSS implantation of the HeartMate 3 LVAD at our institution. Results The median length of stay in the intensive care unit was 3.5 days. No patients required reexploration for postoperative bleeding. There was no incidence of right ventricle failure, stroke, renal failure, hepatic failure, or myocardial infarction. The median length of hospitalization after LVAD implantation was 14.5 days (interquartile range, 12 to 17 days). Conclusions Our early outcomes suggest that the CSS approach may reduce the incidence of right ventricular failure, bleeding, intubation time, and intensive care unit length of stay. Further studies are needed to fully elucidate the advantages of CSS LVAD implantation compared with median sternotomy.

Purpose Right ventricular failure (RVF) remains one of the major cause of morbidity and mortality after left ventricular assist device (LVAD) surgery. The purpose of this study was to investigate the incidence of RVF after less invasive surgery (LIS) LVAD surgery compared to median sternotomy. Methods The study population comprised of 231 patients who underwent HeartMate 3 LVAD implantation in our institution between September 2015 and June 2020. Patients were compared based on surgical approach: full sternotomy (FS) or LIS. The primary outcome was RVF as defined by INTERMACS. Index hospitalization major complications and survival were secondary outcomes. Results LIS approach was used in 161 (69.7%) patients and FS approach in 70 (30.3%) of our LVAD patients. Baseline patient characteristics were similar between cohorts apart from LIS patients being younger (54±14 vs 60±11, p= 0.003). Postoperatively, LIS patients had decreased postoperative bleeding (p=0.001) and shorter time on mechanical ventilation (p Conclusion Less invasive LVAD implantation is associated with improved perioperative outcomes compared to median sternotomy, including a lower incidence of severe right heart failure and need for temporary mechanical circulatory support. Further research is needed to elucidate the mechanism of the less invasive approach in preserving RV function.

Purpose Patient acuity as assessed by INTERMACS profile is significantly correlated to postoperative outcomes for patients undergoing LVAD implantation via median sternotomy. The prognostic utility of INTERMACS profile for the sternal-sparing (SS) approach has yet to be determined. Methods This retrospective, single center study included consecutive patients implanted with a fully magnetically levitated LVAD via the SS approach between February 2018 through June 2019. Patients were compared based on preoperative INTERMACS profile: higher risk (HR) profiles one and two versus lower risk (LR) profiles three or higher. The primary outcome was six-month survival free from disabling stroke or pump exchange. Results Of the 97 total patients implanted via the SS technique, 40 (41%) were HR and 57 (59%) were LR. Besides INTERMACS profile, baseline patient characteristics were similar between cohorts including age (p=0.558), gender (p>0.999) and etiology of heart failure (p=0.224). Postoperatively, the LR cohort had fewer complications and were more likely to be discharged to home (Table 1). Time in the ICU and overall postoperative hospital length of stay were significantly shorter for the LR cohort. Primary outcome was achieved in 96.5% LR vs 82.5% HR cohorts (p=0.015). Conclusion Preoperative INTERMACS profile is correlated with postoperative outcomes for the sternal-sparing approach. Lower risk patients who undergo sternal-sparing implantation demonstrate low rates of complications with excellent mid-term survival. Further research is needed to define the optimal timing of LVAD implantation.

Purpose The present study aimed to compare the outcomes of obese patients who underwent HeartMate 3 implantation through less invasive surgery (LIS) with those who received full sternotomy (FS) implantation. We hypothesized that LIS is a safe and effective technique for LVAD implantation in obese patients. Methods We performed a retrospective review of all patients implanted with HeartMate 3 LVAD in our institution from September 2015 through Jun 2020. Obese patients (BMI≥ 30 kg/m2) were included in the study and dichotomized based on surgical approach into the full sternotomy (FS) cohort or LIS. Primary outcomes were index hospitalization and 30-day survival. Secondary outcomes were incidence of index hospitalization major complications. Results Of 231 patients implanted patients, 107 (46.3%) were obese and included in the study. FS was used in 26 (24.3%) patients and LIS approach in 81 (75.7%) patients. Preoperative patient characteristics were similar between the cohorts (Table 1). In the immediate postoperative course, fewer patients in the LIS cohort received units of packed red blood cells (34.6% vs 57.7%, p=0.042) and fresh frozen plasma (19.8 vs 46.2%, p=0.011). Duration of postoperative inotropic support was shorter in LIS cohort (p=0.049). The incidence of major complications was similar between the groups. Decreased incidence of severe RV failure (30.8% vs 11.1% LIS, p=0.028) and need for RVAD implantation (p=0.037) were observed in LIS cohort. Survival to discharge for the obese population was 87.5% overall and did not differ based on an approach (76.9% FS vs 91.4% LIS, p=0.079). Conclusion These data demonstrate multiple potential benefits of the less invasive surgical technique, including fewer postoperative complications and a trend towards better survival to discharge. This study suggests that less invasive HeartMate 3 implantation is a safe and effective approach for obese patients. Future prospective randomized trials are required to confirm our data.

Purpose Prior study has suggested an association between angulation of the inflow cannula and outcomes following left ventricular assist device (LVAD) implantation. A potential benefit of the sternal-sparing LVAD implantation technique is superior visualization of the apex in its natural anatomic position. Our hypothesis was the sternal-sparing technique would result in more consistent angle of LVAD implantation. Methods This single-center, retrospective review included consecutive patients implanted from September 2015 through September 2019. Patients were stratified via surgical technique: sternal-sparing or median sternotomy. The coronal angle of the inflow cannula relative to the horizontal line was measured on the first available postoperative anterior-posterior chest radiograph (Figure 1). All measurements were calculated by trained radiologists. A randomly selected subgroup of patients was repeated by multiple readers to assess interrater reliability. Results Of the 161 patients included in the study, 102 (63%) were implanted via the sternal-sparing approach. Preoperative patient characteristics were similar between cohorts. The inflow cannula angle was significantly different between cohorts (Figure 1, p=0.020). The sternal-sparing cohort had a more consistent angle (median [IQR], 18 [6-29] degrees) compared to the sternotomy patients (25 [10-42] degrees, p=0.020). Significantly more sternal-sparing patients had an angle ≤65 degrees (100% vs 93%, p=0.017), which has previously been associated with improved patient outcomes with a different model pump. Conclusion Our data suggests the angle of the inflow cannula after LVAD implantation is more consistently reproduced when utilizing the sternal-sparing approach compared to median sternotomy. Further research is needed to examine the relationship between inflow cannula angle and patient outcomes to determine the ideal inflow cannula angle for the fully magnetically levitated pump.

Purpose Thromboembolic events (TEs) remain common adverse events for left ventricular assist device (LVAD) patients. There is early evidence that left atrial appendage occlusion (LAAO) at the time of LVAD implantation may reduce the incidence of TEs, but the feasibility of LAAO during less invasive LVAD implantation is unknown. Methods Patients who underwent LAAO during LVAD implantation via the complete sternal-sparing (CSS) approach were retrospectively reviewed. LAAO was performed through the left thoracotomy incision using a commercially available left atrial appendage exclusive device. Preoperative patient characteristics, intraoperative data, and postoperative complications were collected. The primary outcome was incidence of intraoperative complications. Secondary outcomes included operative time, successful placement of exclusion device, and incidence of postoperative TEs. Results A total of 8 patients underwent concurrent LAAO at the time of CSS LVAD implantation. Average age was 62 ±12 years and five (63%) patients were male. Two patients (25%) were INTERMACS Profile 1, five (63%) Profile 3, and one (12%) was Profile 4. Four patients (50%) had evidence of preoperative left ventricular thrombus, and six (75%) had a history of arrhythmia. All patients received a fully magnetically levitated LVAD. There were no intraoperative complications and all patients had evidence of complete atrial appendage occlusion on intraoperative transesophageal echocardiogram. Performing LAAO did not significantly increase operative time compared to CSS implantation without concomitant LAAO. Median postoperative length of stay was 12 [10-13] days. During a total of 587 patient-days of follow-up, one patient suffered a non-disabling thrombotic stroke with no residual defects and one patient died from unrelated causes. Conclusion LAAO is feasible via the left thoracotomy incision during CSS LVAD implantation. Early evidence suggests the procedure is safe and effective at occluding the left atrial appendage. Further research is needed to determine potential long-term benefits.

Purpose The purpose of this study was to examine the association between surgical implantation technique and the incidence of postoperative severe right heart failure (RHF). Methods We performed a retrospective review of all patients implanted with a continuous flow left ventricular assist device (LVAD) at our institution from May 2008 through June 2019. Patients were dichotomized based on surgical implantation technique: sternal-sparing (SS) or median sternotomy. Multivariate logistic regression was performed to adjust for preoperative patient characteristics. The primary outcome was the incidence of severe RHF during the index hospitalization as defined by INTERMACS. Results Of the 426 total patients, 103 (24%) were implanted via sternal-sparing approach and 323 (76%) via median sternotomy. Preoperative patient characteristics were similar between cohorts except for younger age in the SS cohort (53 ±14 vs 57 ±12 years, p=0.016). A large proportion of both cohorts presented as INTERMACS Profile 1 (39% SS vs 37% sternotomy, p =0.726). Intraoperatively, both cohorts had similar cardiopulmonary bypass times (117±51 vs 108±46 minutes, p=0.065). Postoperatively, there was a lower incidence of severe RHF in the SS cohort (9% vs 23%, p=0.001), including fewer cases requiring a right ventricular assist device (3% vs 15%, p=0.001). In a multivariate model, sternal-sparing approach (Odds Ratio 0.36 (0.17-0.78), p=0.010) and INTERMACS Profile ≥3 (Odds Ratio 0.15 (0.07-0.30), p Conclusion Sternal-sparing LVAD implantation is associated with a lower incidence of severe right heart failure compared to median sternotomy. Further research is needed to elucidate the mechanism of the sternal-sparing approach in preserving RV function.

Purpose Less invasive techniques for left ventricular assist device (LVAD) implantation have shown promising outcomes but are associated with significant postoperative pain. We aimed to investigate the use of ultrasound-guided regional nerve blocks to improve pain management during these procedures. Methods We retrospectively reviewed patients implanted with a HeartMate 3 LVAD via complete sternal-sparing approach at our institution from February 2018 to July 2018. Patients were grouped based on their postoperative pain management plan - those who received a regional nerve block plus multi-modal analgesia and a control group who received standard multi-modal analgesia alone. Pain scores and analgesic use were recorded for all patients during the initial 72 hours postoperatively. Results Preoperative characteristics were similar between cohorts. Of the 28 patients included in the study, 15 (54%) received a postoperative regional nerve block. Patients who received a nerve block had significantly lower pain scores (Figure 1) and required a lower dose of opioid analgesics (70.7 ± 13.9 vs 124.6 ± 19.3 morphine equivalents, p = 0.029) during the first 72 hours postoperatively (Figure 2). There was no difference in time to extubation, intensive care unit length of stay or hospital length of stay. Conclusion Optimizing postoperative analgesia using a regional nerve block is associated with decreased opioid use and decreased postoperative pain after complete sternal-sparing LVAD implantation. Regional nerve blocks should be included as part of a protocol-based postoperative pain management program.

Purpose Left ventricular assist device (LVAD) implantation via a complete sternal-sparing (CSS) technique is gaining interest due to several associated benefits. We hypothesized that the CSS approach for HeartMate 3 LVAD implantation improves postoperative mobility and physical independence compared to full sternotomy (FS). Methods We retrospectively reviewed all patients implanted with a commercial HeartMate 3 at our institution from September 2017 to August 2018 (N=52). Patients were grouped based on surgical technique, CSS or FS. Patients were excluded if they did not see a physical therapist within three weeks postoperatively. The Activity Measure for Post Acute Care (AM-PAC) short forms and Functional Independence Measure (FIM) scores were used to assess postoperative mobility and physical limitations. Results A total of 43 patients were included in the study; 27 (63%) were implanted via the CSS approach and 16 (37%) underwent FS. Preoperative characteristics were similar between cohorts. By postoperative day 3 (POD3), the CSS cohort demonstrated improved mobility based on AM-PAC scores compared to the FS group (Figure 1) with 40% of the CSS cohort versus 67% of the FS cohort remaining 100% impaired. The CSS cohort also demonstrated greater postoperative independence in the FIM sit-to-stand metric (Figure 2) with 78% of the CSS cohort achieving modified or complete independence by POD15 compared to 21% of the FS patients. Conclusion The CSS approach for HeartMate 3 LVAD implantation improves postoperative mobility and functional independence compared to FS.

Purpose Previous studies have demonstrated poor survival for patients supported by extracorporeal membrane oxygenation (ECMO) as a bridge to left ventricular assist device (LVAD) implantation. We hypothesize that ECMO can be used as an effective strategy for bridge to LVAD. Methods We retrospectively reviewed all patients implanted with a HeartMate 3 (HM3) at our institution from September 2017 through September 2018. Patients preoperatively supported by ECMO were identified and patient characteristics, intraoperative data and postoperative outcomes were recorded. A sub-group analysis was performed comparing outcomes for patients implanted via a complete sternal-sparing (CSS) approach versus full sternotomy (FS). Results A total of 16 (25%) patients were supported by ECMO preoperatively. Nine (56%) patients also required an intra-aortic balloon pump or Impella for additional support (Table). CSS was utilized in 9 (56%) patients and FS in 7 (44%). Median intensive care unit length of stay was 6 days [IQR, 4-18.5] with median total hospital length of stay of 20.5 days [13-37.5]. Survival to discharge was achieved in 81% of patients with 63% of the patients being discharged to home. The subgroup analysis showed a trend in improved outcomes for the CSS compared to FS cohort, including less postoperative chest tube drainage (1095.5 [878.5-1850] vs 2295 [1470-2800], p = 0.037) and less time on mechanical ventilation support (26 [13-134] vs 96 [49-456] hours, p = 0.039). There was no difference in intensive care unit length of stay, hospital length of stay or overall mortality between cohorts. Conclusion ECMO is a viable and effective strategy to stabilize critically ill patients as a bridge to long term mechanical support. The less invasive CSS approach demonstrates a trend towards favorable perioperative outcomes compared to traditional FS and warrants further study.

Purpose Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is an important but resource intensive therapy for refractory cardiogenic shock. We aimed to identify the utility of early elevated lactate levels as a predictor of ECMO mortality. Methods We retrospectively reviewed patients supported by VA-ECMO from 2011-2018 (N=247). Patients were grouped into a mortality cohort consisting of patients that died during index hospitalization and a survival cohort of those that survived to hospital discharge. Patient characteristics, comorbidities and lactate levels during index hospitalization were compared between cohorts. Results Of the 247 patients, 80 survived (33%). Lactate levels were significantly higher in the mortality cohort at multiple time points including: average lactate before ECMO (7.08 vs 4.25 mmol/L, p Conclusion Mean lactate level during the initial 12h of VA-ECMO support is both a sensitive and specific predictor of mortality. Early lactate levels can assist with the often difficult decisions associated with VA-ECMO. More research is necessary to develop a robust prediction model to aid in the clinical decision making early after ECMO initiation.

A 74-year-old man with a past medical history of diabetes mellitus, hypertension, severe aortic stenosis, coronary artery disease status post-coronary artery bypass surgery with left internal mammary artery, vein graft, and aortic valve replacement with a Rapid Deployment Edwards 23-mm Intuity Elite

Background Management of existing aortic insufficiency (AI) and mechanical aortic valves in patients undergoing left ventricular assist device (LVAD) implantation remains controversial. Surgical options to address these issues include closure, repair or replacement of the valve. Methods Continuous-flow LVAD/biventricular VAD patients entered into the INTERMACS database between June 2006 and December 2012 were included ( n = 5,344) in this analysis. Outcomes were compared between patients who underwent aortic valve (AV) closure ( n = 125), repair ( n = 95) and replacement ( n = 85). Results Among patients who underwent an AV procedure, actuarial survival was significantly reduced for AV closures (63.2%) compared with AV repairs (76.8%) and replacements (71.8%) ( p = 0.0003). Differences were greater between groups when only INTERMACS Level 1 or 2 patients were analyzed ( p = 0.003). After multivariate adjustment, AV closure remained a significant risk factor for mortality (hazard ratio=1.87, 95% confidence interval 1.39 to 2.53, p p Conclusions AV closure was associated with increased mortality when compared with repair or replacement in patients with AI who underwent LVAD insertion. The reasons for this association require further investigation. This is the largest study to date to examine concomitant AV procedures in patients undergoing LVAD insertion.

This study evaluated clinical outcomes associated with erythropoiesis stimulating agent (ESA) use in left ventricular assist devices (LVAD)-supported patients.Use of ESAs in patients with LVADs may minimize blood transfusions and decrease allosensitization. ESAs increase thrombotic events, which is concerning because LVADs are sensitive to pump thrombosis (PT).We retrospectively reviewed 221 patients at our center who received a HeartMate II (Thoratec Corp., Pleasanton, California) LVAD between January 1, 2009 and June 6, 2013. Patients were divided into those who received ESAs during index admission (n = 121) and those who did not (n = 100). Suspected PT was defined as evidence of thrombus in the LVAD or severe hemolysis (lactate dehydrogenase1,000 mg/dl or plasma-free hemoglobin40 mg/dl). Outcomes were compared between cohorts using inverse probability-weighted analyses.During a mean follow-up of 14.2 ± 11.9 months, suspected PT occurred in 37 patients (ESA 23%, no ESA 12%; p =0.03). The ESA cohort received ESAs 13.9 ± 60.9 days after LVAD implantation. At 180 days, event-free rates for suspected PT were ESA 78.6% versus no ESA 94.5% (p 0.001). ESA use had higher rates of suspected PT (hazard ratio [HR]: 2.35; 95% confidence interval [CI]: 1.38 to 4.00; p = 0.002). For every 100-unit increase in cumulative ESA dosage, the hazard of suspected PT increased by 10% (HR: 1.10; 95% CI: 1.04 to 1.16; p 0.001). After inverse probability weighting, ESA use was associated with a significantly higher rate of all-cause mortality (HR: 1.62; 95% CI: 1.12 to 2.33; p = 0.01).ESA use in LVAD patients is associated with higher rates of suspected PT.

Purpose The purpose of this study was to evaluate early outcomes for INTERMACS Profile 3 and 4 patients implanted with the complete sternal-sparing Heartmate 3 surgical technique. Methods Retrospective analysis of prospectively collected data was performed on 53 consecutive patients implanted with left ventricular assist devices between February and September 2018 at a single institution. Patients were excluded if they were enrolled in a study requiring full sternotomy (3 patients), underwent pump exchange (5 patients), or were implanted with the HeartWare device (4 patients). Early clinical outcomes and survival at 30-days were evaluated for all INTERMACS Profile 3 and 4 patients. Results Of the 41 total patients, 18 (44%) were INTERMACS 3 or 4 at time of implantation and were included in this study. All patients underwent complete sternal-sparing HeartMate3 implantation with no conversions to full sternotomy. Average age was 54.6 ±16.1 years and 67% were male (Table). One patient (6%) returned to the operating room for bleeding. No patients required RVAD support. Median intubation time was 16 [IQR=7-34] hours. Median intensive care unit and hospital length of stay were 3 [IQR=2-4] days and 14 [IQR=12-18] days, respectively. One patient (6%) was readmitted within 30-days for gastrointestinal bleeding. Thirty-day survival was 100% (18/18). Conclusion In our single center experience, complete sternal-sparing HeartMate 3 implantation of INTERMACS 3 and 4 patients is safe with a low complication rate and excellent perioperative outcomes. Multicenter studies are required to further validate this less invasive surgical technique.

Purpose Patients with a history of previous sternotomy often pose difficult surgical challenges for subsequent cardiac procedures. We hypothesized that the less invasive complete sternal-sparing approach would demonstrate favorable outcomes compared to full sternotomy (FS) for patients with a history of previous sternotomy. Methods We retrospectively reviewed all patients implanted with a HeartMate 3 (HM3) at our institution from September 2017 through September 2018 (n=63). Patients were included if they had history of prior sternotomy and separated into groups based on LVAD implantation technique: CSS versus re-operative sternotomy. Preoperative characteristics and postoperative outcomes were compared between cohorts. Results Of the 17 (30%) HM3 patients with a history of previous sternotomy, 10 (59%) were implanted via CSS and 7 (41%) by re-operative sternotomy. The CSS cohort tended to be older (65±6 vs 56±11 years, p = 0.055) and more likely to have undergone CABG (80% vs 14%, p = 0.015) while the FS cohort was more likely to have undergone previous aortic valve replacement (71% vs 10%, p = 0.035) (Table). The CSS cohort demonstrated fewer overall complications (30% vs 86%, p = 0.050) including a decreased incidence of severe right ventricular failure (0% vs 57%, p = 0.015). There was a trend towards shorter ICU length of stay (median, [IQR]; 4 [3-6] vs 14 [4.5-32] days, p = 0.218), total hospital length of stay (13 [12-24] vs 32.5 [20.5-61.5] days, p = 0.104) and improved 30-day survival (90% vs 57%, p = 0.250) in the CSS cohort. Conclusion LVAD implantation via CSS approach demonstrates fewer complications and decreased incidence of severe right ventricular failure in patients undergoing re-operative cardiac surgery. The CSS approach is our preferred surgical implantation technique for this patient population.

Purpose The ENDURANCE and ENDURANCE Supplemental Trials were designed to study the safety and efficacy of the HeartWare LVAD (HVAD) to support patients with advanced heart failure ineligible for transplant compared to the control HM2 device. There is increasing interest in the “less sick” patient with advanced heart failure. It is reasonable to assume that the total length of post-implant hospital stay would be correlated with less perioperative morbidity. Methods The ENDURANCE Trial prospectively randomized 465 patients with advanced heart failure to receive the HVAD (N=296) or the HM2 Control (n=149), and the ENDURANCE Supplemental Trial prospectively enrolled 465 patients (308 HVAD versus 157 control, HM2) with added improved blood pressure management. Data from these trials supported the FDA approval of the HVAD System for destination therapy in advanced heart failure patients. We now present a retrospective analysis of the total length of hospital stay (LOS) following LVAD implant. We separated the patients into 3 groups based on their total hospital stay, and performed Kaplan-Meier analysis as well as freedom from major LVAD-related adverse events over the 24 months post-implant Results There was an inverse relationship between total length of post-implant LOS and survival (p Conclusion The finding that total length of post-implant hospital stay is inversely related to survival is important especially considering the lack of difference in the freedom from bleeding, infection, stroke, and thrombotic events in these subgroups. These data suggest that LOS and subsequent survival is not necessarily related to VAD-related complications, but perhaps to underlying patient baseline condition.

Purpose The purpose of this study was to evaluate discharge patterns, days spent out of hospital and 90-day readmission rates after utilizing the complete sternal-sparing technique for HeartMate3 implantation. Methods Retrospective analysis of prospectively collected data was performed on 36 consecutive patients implanted with left ventricular assist devices between February and July 2018 at a single institution. Patients were excluded if they were enrolled in a study requiring full sternotomy (1 patient), were a pump exchange (5 patients), or were implanted with the HeartWare device (2 patients). Results A total of 28 patients were included in the study, all of which underwent complete sternal-sparing HeartMate 3 implantation. Two patients died during the initial hospitalization. Average age was 56.0±11.7 years, 77% were male and 50% were INTERMACS Profile 1. Intensive care unit and hospital length of stay were 4.5 days (IQR=2-7 days) and 15 days (IQR=12-31days), respectively. Seventeen patients (65%) were discharged home, and nine patients (35%) were discharged to acute rehab. After hospital discharge, patients spent 97% of their time out of the hospital. Three patients (12%) were readmitted to the hospital, one of whom was readmitted twice. Reasons for readmissions included gastrointestinal bleed, bacteremia, anemia and syncope. Ninety-day survival was 26/28 (93%). Conclusion In our single center experience, two thirds of patients were discharged home after HeartMate 3 implantation using less invasive surgical techniques. Along with short hospital stays, we observed a low 90-day readmission rate. Multicenter studies are required to further validate the benefits of less invasive HeartMate 3 implantation.

Purpose Patient-Reported Outcomes Measurement Information System (PROMIS) is a computerized assessment that has been validated across multiple disciplines and chronic disease states. There is limited use of PROMIS in the heart failure patient population. We describe PROMIS scores in a large LVAD patient cohort and compare functional domain measurement to the Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Methods LVAD patients completed the PROMIS computer adaptive test for physical function, pain and depression in addition to the KCCQ-12 survey at outpatient visits. PROMIS instruments are standardized to a mean score of 50 for the general population. Only KCCQ-12 completed within 90 days of a PROMIS score were included in the analysis. The nonparametric Spearman's rank correlation measure was used to estimate the strength of the relationship between the PROMIS function score and the KCCQ-12 measure. Results From June 2017 to August 2018, 271 PROMIS scores were completed from 132 different LVAD patients (55 ± 11 years old; 81% male; 58% BTT). Time since LVAD implantation ranged from 32 days to over 8 years (median 945 days). Compared to the general population, LVAD patients reported worse functional status but similar levels of pain and depression (Figure 1). KCCQ-12 was captured for 73 different patients and demonstrated significant positive correlation between the instruments (0.713, p Conclusion The PROMIS score shows a good correlation with the KCCQ-12 in LVAD patients. Further study is needed to determine its utility in predicting outcomes.

Purpose Obese patients supported by continuous flow left ventricular assist devices (LVADs) have comparable outcomes to those with a normal BMI. However, cardiac surgery in obese patients is associated with increased procedural complexity and morbidity. We describe our early outcomes using the complete sternal-sparing (CSS) approach for HeartMate 3 (HM3) implantation in obese patients. Methods We retrospectively reviewed all commercial HM3 implants at our institution through September 2018. Patients were separated into two groups based on BMI Results Of the 41 patients who underwent complete sternal sparing HM3 implantation, 18 (44%) were obese. The non-obese cohort had an average BMI of 24.8 ±2.8 compared to the obese cohort average BMI of 37.2 ±5.9. Six patients (15%) were extremely obese (BMI >40) (Figure). Preoperative characteristics and illness severity were similar between patient cohorts including > 39% of INTERMACS 1 patients in each group (Table). There was no significant difference in intraoperative data or early clinical outcomes. Both obese and non-obese patients demonstrated similar intensive care unit and hospital lengths of stay. There was no difference in 30-day survival or 30-day readmission rate. Conclusion The CSS approach is a safe and effective technique for LVAD implantation in obese patients. There is no increased risk of morbidity or mortality between obese and non-obese patients implanted with the HM3 LVAD using the CSS approach.

Purpose The purpose of this study was to analyze early outcomes, safety and reproducibility of the less invasive HeartMate 3 implantation technique. Methods Retrospective review of prospectively collected data was performed on 53 consecutive patients implanted with left ventricular assist devices between February and September 2018 at a single institution. Patients were excluded if they were enrolled in a study requiring full sternotomy (3 patients), were a pump exchange (5 patients) or were implanted with the HeartWare device (4 patients). Safety outcomes included return to the operating room and overall survival. Results A total of 41 patients were included in the study. Thirty-nine patients were implanted with the complete sternal-sparing technique while two had an upper hemi-sternotomy with small left anterior thoracotomy. Average age was 53.6±13.9 years, 76% were male and 41% were INTERMACS Profile 1. Twelve patients (29%) had a right ventricular stoke work index less than 400. Nine patients (22%) were implanted off VA ECMO and 10 patients (24%) had previous cardiac surgery. All patients that qualified for the procedure were implanted using a less invasive technique. No patients required conversion to full sternotomy. Two patients (5%) returned to the operating room for bleeding. Twenty patients (49%) received a perioperative packed red blood cell transfusion within 24 hours of surgery. Median blood loss in the first 24-hours was 1042 mL (IQR=768-1307 mL). 2 patients (5%) requiring RVAD support. Median intubation time was 16 hours (IQR=9-34 hours). Median intensive care unit and hospital length of stay were 4 days (IQR=2-6 days) and 15.5 days (IQR=12-23 days), respectively. Thirty-day survival was 39/41 (95%). Conclusion Less invasive HeartMate 3 implantation in our single center setting is safe and reproducible with excellent outcomes. Multicenter studies are required to further validate this technique.

Background Epithelioid hemangioendothelioma (EHE) is a rare vascular neoplasm of endothelial origin with clinical behavior intermediate between hemangioma and angiosarcoma. The natural history of EHE is highly variable. This study uses an Internet registry to identify clinical patterns with prognostic significance in EHE. Methods Cases from the International Hemangioendothioma, Epithelioid Hemangioendothelioma, and Related Vascular Disorders (HEARD) Support Group were evaluated based on demographics, organ involvement, disease progression, presence or absence of pleural effusion, and treatment. Survival among various cohorts was compared using log-rank analysis of Kaplan-Meier plots. Results Two hundred sixty-four patients were identified from April 2004 to November 2009. Fifty-eight cases were excluded because of inadequate information or wrong diagnosis. EHE was more common in female patients (61%). Male gender and age ≥ 55 years were associated with decreased survival. The most commonly affected organs were liver, lung, and bone. No specific organ or combination of organ involvement differentially affected survival, and survival was no different between patients with multiple vs single organ involvement. However, pattern B, defined as lesions without distinct borders (eg, pulmonary infiltrates, pleural effusion, ascites), hemoptysis, or involvement of more than two bones adversely affected survival in all cohorts. Conclusion A novel staging system with prognostic value for EHE is proposed. Pleural effusion or other signs of uncontained tumor growth, hemoptysis, and osseous involvement of more than two bones implied worse survival than did localized and discrete tumors, regardless of number of organs involved. A lay registry can provide useful insights into the clinical behavior of a rare cancer.

Cardiomyopathy (CM) is generally treated with generic heart failure medications, namely diuretics, beta blockers and afterload reduction. Extracorporeal membrane oxygenation (ECMO) can be used in patients with cardiogenic shock (CS) who do not respond to conventional therapy. A 32 year old female

Background The University of Wisconsin (UW) solution is the gold standard for heart preservation but has limitations in terms of both duration and adequacy of protection. Our laboratory has been interested in a more physiologic approach to heart preservation by maintaining the heart at its resting membrane potential (hyperpolarized arrest) with the KATP channel agonist pinacidil. This study compared our extracellular solution (WashU) with the UW intracellular depolarizing solution and quantified the protective effect of pinacidil in both solutions. Methods Thirty-two rabbit hearts received 1 of 4 solutions in a crystalloid-perfused Langendorff apparatus: (1) UW, (2) WashU containing 0.5 mmol/liter pinacidil, (3) UW with 0.5 mmol/liter pinacidil, or (4) WashU without pinacidil. Thirty minutes of perfusion was followed by data acquisition consisting of left ventricular pressure-volume curves generated by inflating an intraventricular balloon. All hearts were placed in cold storage for 8 hours, followed by 1 hour of reperfusion before data acquisition. Results Post-ischemic developed pressure (DP) was better preserved by WashU (76.8% ± 3.8%) than by UW (48.3% ± 2.5%). Diastolic compliance was better preserved by WashU (239.9% ± 77.2%) compared with UW (711.1% ± 193.1%). Removing pinacidil from our solution resulted in decreased DP (46.6% ± 3.2%) and diastolic compliance (688.8% ± 158.2%) Adding pinacidil to UW had a limited effect on DP and compliance. Conclusions Our results support the superiority of the WashU hyperpolarizing solution for heart preservation over UW. Pinacidil was beneficial in maintaining cardiac function and compliance. This benefit was not observed when pinacidil was placed into the UW depolarizing solution.

Robotic systems are being used by an increasing number of surgeons. This environment is markedly different from that of traditional surgery and involves videoscopic guidance, remote surgical control, and the loss of haptic feedback. Defining how surgeons learn with these systems is necessary to establish training protocols for this technology. This study compared the learning curve for a robotic surgical system with that of traditional endoscopy in the performance of two standardized skill drills.Twenty participants (average age 27 +/- 4 years, six females) repeated two standardized endoscopic dexterity and depth perception drills for 15 repetitions with the ZEUS robotic surgical system and manual endoscopic instruments (MAN). A score combining time and precision was given for each repetition. The learning curves and overall performance with and without robotic assistance were compared.For both MAN and ZEUS, improvements in performance were significantly greatest during the first five repetitions (P0.01, for both). Participants reached the training curve plateau faster with ZEUS than with conventional instruments (8th versus 10th for both drills). Using robotic assistance, dominant and non-dominant hand performance were statistically similar. The number of errors committed with ZEUS were significantly fewer for drill two (0.09 errors/repetition versus 0.24 errors/repetition, P = 0.002) compared to manual technique.This study demonstrated that training curves for conventional and robotic-assisted systems are remarkably similar. This should prove useful in the training and education of this new technology. This study further suggested that robotics may increase ambidexterity by improving non-dominant hand performance.

Background The Cox-Maze III remains the gold standard for the surgical treatment of atrial fibrillation. However, the "cut-and-sew" technique is time consuming and technically challenging. The pulmonary veins are the source of ectopy in the majority of patients with atrial fibrillation. The safety and efficacy of bipolar radiofrequency to electrically isolate the pulmonary veins was evaluated in a prospective multi-center trial. Methods Beginning in January 2002, 30 patients at three medical centers underwent pulmonary vein isolation using bipolar radiofrequency and were followed for 6 months. Twenty-four of the patients also underwent a modified Cox-Maze III. Electrical isolation of the pulmonary veins was confirmed with intraoperative pacing. Pulmonary vein patency was assessed by magnetic resonance imaging or three-dimensional computed tomography in 15 patients at 1 month. Results Mean age was 60.9 ± 11.7 years. Nineteen patients had paroxysmal atrial fibrillation. All pulmonary veins were isolated in every patient. The left pulmonary veins underwent 3.0 ± 1.4 applications for a total of 26.4 ± 10.5 seconds. The right pulmonary veins underwent 2.8 ± 1.1 applications for a total of 26.3 ± 12.6 seconds. There was no operative mortality. At 1 month, imaging revealed no evidence of pulmonary vein stenosis. At 6 months, 96% of patients were in normal sinus rhythm. Conclusions The use of bipolar radiofrequency for electrical isolation of pulmonary veins and to replace other Cox-Maze III incisions is safe and effective at controlling atrial fibrillation. This emerging technology may shorten and simplify the surgical management of atrial fibrillation.

ObjectiveThe Cox maze III procedure has excellent long-term efficacy in curing atrial fibrillation. It has not been widely practiced because it is technically challenging and requires prolonged cardiopulmonary bypass. The aim of this study was to examine a simplified Cox maze III procedure that uses bipolar radiofrequency energy as an ablative source.MethodsBeginning January 2002, a total of 40 consecutive patients underwent a modified Cox maze III procedure with bipolar radiofrequency energy. Nineteen had a lone maze procedure and 21 had a maze procedure plus a concomitant operation. One month after the operation, the first 8 patients were investigated with high-resolution magnetic resonance imaging. Patients were followed up monthly with clinical examination and electrocardiography.ResultsThere was no operative deaths. The crossclamp times were 47 ± 26 minutes for the modified lone Cox maze III procedure and 92 ± 37 minutes for the Cox maze III procedure plus concomitant procedures. These were significantly shorter than our previous times for the traditional Cox maze III procedure (93 ± 34 minutes and 122 ± 37 minutes, respectively, P < .05). Follow-up magnetic resonance imaging showed no evidence of pulmonary vein stenosis, and atrial contractility was preserved in all patients. There were no late strokes. At 6-month follow-up, 91% of patients (21/23) were in sinus rhythm.ConclusionsBipolar radiofrequency ablation can be used to replace the surgical incisions of the Cox maze procedure. This energy source did not result in pulmonary vein stenosis. The modification of the Cox maze III procedure to use bipolar radiofrequency ablation simplified and shortened this procedure without sacrificing short-term efficacy.

Background For the last decade, the Cox maze III procedure has been available for the treatment of atrial fibrillation. It is unknown whether the operation has similar efficacy in patients with lone atrial fibrillation compared with that in patients with atrial fibrillation associated with coronary, valve, or congenital heart disease. This study examined the long-term outcome of patients who underwent this procedure either as a lone operation or as a concomitant procedure. Methods From 1988 to 2001, 198 patients underwent a Cox maze III procedure; 112 were lone operations, and 86 were concomitant procedures. Major complications included renal failure, reoperation for bleeding, mediastinitis, stroke, and balloon pump insertion. Follow-up was performed by means of mail and telephone questionnaires with both the patients and their cardiologists. All patients who had any history of arrhythmia or who were taking medication had their rhythm documented by means of electrocardiography. Results The lone operation group was significantly younger (51.3 ± 10.5 vs 58.8 ± 9.9 years) and had a higher male/female ratio (4:1 vs 2:1). There was no difference in operative mortality between groups (1.8% vs 1.2%). At a follow-up of 5.4 ± 2.9 years, 96.6% (172/178) of all patients were free of atrial fibrillation. There was no difference between the lone operation and concomitant procedure groups (95.9% vs 97.5%). Conclusion The Cox maze III procedure has equivalent operative risk and long-term efficacy in patients undergoing both lone operations and concomitant procedures. The Cox maze III procedure remains the standard against which alternative procedures for atrial fibrillation must be judged.

Background A significant number of patients presenting for coronary revascularization have chronic atrial fibrillation. Although the Cox maze III procedure is the gold standard for the surgical treatment of this arrhythmia, few of these patients undergo atrial fibrillation operations at the time of their coronary bypass grafting. This study examined the long-term outcome of patients with ischemic heart disease who underwent the Cox maze procedure at our institution. Methods From 1990 to 2002, 47 patients undergoing operations for ischemic heart disease underwent a concomitant Cox maze III procedure. All patients underwent coronary bypass grafting, and 7 (15%) patients underwent coronary bypass grafting plus a mitral valve repair. Follow-up was performed by means of mail and telephone questionnaires with both the patients and their cardiologists. All patients who had any history of arrhythmia or who were taking medications had their rhythm documented by electrocardiogram. Results The mean age of these patients was 62 ± 8 years, with a marked male predominance (45 men and 2 women). Twenty-eight (60%) of the patients had paroxysmal atrial fibrillation, and the remainder had persistent arrhythmias. The mean duration of atrial fibrillation was 7.6 ± 6.5 years. The operative mortality in this series was 2%. Nine (19%) patients required postoperative pacemakers. At last follow-up (mean of 5.7 ± 3.3 years), 98% of patients were free of atrial fibrillation. Conclusion The Cox maze III procedure has a low operative mortality and excellent long-term efficacy in patients with ischemic heart disease. These data suggest a more widespread use of this procedure in these patients.

Background: Recently, there has been renewed interest in the development of minimally invasive procedures to treat atrial fibrillation. Unipolar radiofrequency catheters are plagued by poor results, in part because of their inability to produce transmural lesions. This study tested the ability of bipolar radiofrequency energy to create chronic transmural lesions on the beating heart that isolated atrial myocardium. Methods: Five sheep underwent a right thoracotomy. Baseline pacing was performed from the following targeted areas: right atrial appendage, superior vena cava, inferior vena cava, and right pulmonary veins. A cuff of atrial myocardium around the targeted tissue was clamped between the 2 arms of the device. Radiofrequency energy was delivered at 750 mA and continued until the tissue conductance between the electrodes reached a stable minimum level. After ablation, pacing was used to document tissue isolation. The animals survived for 30 days. Results: Twenty circumferential lesions were produced at the initial operation. The mean ablation time was 9.3 ± 4.0 seconds, and the mean peak temperature was 48.4°C ± 6.4°C. All lesions acutely and chronically isolated the targeted tissue. Trichrome staining showed that all lesions were transmural. There were no instances of pulmonary vein stenosis or thrombosis. Conclusions: Bipolar radiofrequency energy can produce permanent transmural linear lesions on the beating heart. Online measurement of tissue conductance reliably predicted lesion transmurality. This new technology may enable surgeons to perform a curative minimally invasive operation for atrial fibrillation on the beating heart. J Thorac Cardiovasc Surg 2002;124:708-13

Objective: The purpose of this study was to evaluate the effect of target vessel characteristics on radial artery patency when used as a composite T graft. Methods: Between October 1993 and March 2001, 1022 patients underwent coronary bypass with the internal thoracic artery–radial artery composite T graft. Of these, angiography has been performed on 109 patients at a mean 27.1 months (range, 2-70 months) postoperatively for symptoms of ischemia. By means of Cox proportional hazard models, the relationships between anastomotic patency and target vessel location, proximal stenosis, target diameter, and quality were assessed. Results: A total of 231 radial artery anastomoses were evaluated. The mean stenosis for patent anastomoses was 82% compared with 71% for occluded anastomoses (P

Background . This multicenter prospective trial was designed to assess the safety and efficacy of using a robotically-assisted microsurgical system to create endoscopic coronary anastomoses. Methods . Thirty-two patients scheduled for elective primary coronary surgery underwent endoscopic anastomosis of the left internal thoracic artery (LITA) to the left anterior descending (LAD) artery. Three thoracic ports (two for instruments and one for a camera) were placed, and a robotic system was used to perform the LITA–LAD graft. Conventional techniques were used to perform the other grafts. Thirty-one patients underwent median sternotomy and 1 patient underwent a limited anterior thoracotomy. Results . Graft flow was measured in the operating room and averaged 37 ± 19 mL/min. Mean anastomosis time was 24 ± 9 minutes. There were three intraoperative revisions (9%). Two were for inadequate flow and one for an inadvertent injury. Each of these grafts was successfully revised by hand. There were no technical failures of the robotic system. Average postoperative length of stay was 5.5 ± 2.7 days. There were three reoperations for bleeding, but none of these were related to the LAD anastomosis. Two months following the operation, selective angiography revealed a graft patency of 93%. The patients have been followed for 16 ± 4 months. Conclusions . This initial prospective multicenter trial documents the feasibility of robotically-assisted coronary bypass grafting. Further trials are warranted to establish the safety and efficacy of this new technology.

Warm cardioplegic induction improves the ischemically "stressed" adult heart. However, it is rarely used in infants, despite the fact that many newborn hearts are stressed by other factors such as hypoxia. The need for amino acids as well as their mechanism of action has also not been studied.We first assessed the role of cardioplegic induction temperature in 10 nonhypoxic neonatal piglets undergoing 70 minutes of multidose blood cardioplegic arrest. Five piglets (group 1) received a cold (4 degrees C) induction, and 5 (group 2) a warm (37 degrees C) induction. Twenty-six other piglets underwent ventilator hypoxia (fraction of inspired oxygen, 8% to 10%) for 60 minutes before cardiopulmonary bypass (stress). Six piglets (group 3) then underwent 70 minutes of cardiopulmonary bypass without ischemia (hypoxia controls), and 20 underwent 70 minutes of cardioplegic arrest. Five of these (group 4) received cold cardioplegic induction, and 15 received warm induction; in 5 of these (group 5), the warm cardioplegic solution contained amino acids, in 5 others (group 6), it was unsupplemented, and in the remaining 5 (group 7), nitroglycerin was added to determine the role of vasodilation. Myocardial function was assessed by pressure-volume loops (expressed as a percent of control), and coronary vascular resistance was measured with cardioplegic infusions.In nonhypoxic (normal) piglets, cold (group 1) and warm (group 2) induction completely preserved systolic function (end-systolic elastance, 100% versus 104%) and preload recruitable stroke work (100% versus 102%), with minimal increase in diastolic compliance (162% versus 156%). Hypoxia-reoxygenation alone (group 3) depressed systolic function (end-systolic elastance, 51%+/-2%) and preload recruitable stroke work (54%+/-3%), and raised diastolic stiffness (260%+/-15%). The detrimental effects of reoxygenation persisted (unchanged from reoxygenation alone) with cold induction (group 4) or warm induction without amino acids (groups 6 and 7). In contrast, warm induction with amino acids (group 5) restored systolic function (end-systolic elastance, 105%+/-3%; p0.001 versus groups 3, 4, 6, and 7) and preload recruitable stroke work (103%+/-2%; p0.001 versus groups 3, 4, 6, and 7), and decreased diastolic stiffness (154%+/-7%; p0.001 versus groups 3, 4, 6, and 7). However, there was no difference in myocardial oxygen consumption in hypoxic hearts receiving a warm induction (6.9 versus 6.5 versus 7.3 mL/g per 5 minutes) (groups 5, 6, 7), and coronary vascular resistance was lowest with nitroglycerin (group 7).Cardioplegic induction can be given either warm or cold in nonhypoxic neonatal hearts. In contrast, only warm induction with amino acids repairs the hypoxic injury, but the primary mechanism of action is not related to increased metabolic activity or vasodilation.

ObjectiveTo assess the effect of extremity vascular complications (EVCs, including ischemia or vessel trauma) on the outcomes of patients receiving cardiac support devices (CSDs, including ventricular assist device [VAD] and extracorporeal membrane oxygenation [ECMO]).MethodsInstitutional Review Board-approved, retrospective review of a prospectively maintained database of all temporary and permanent CSD recipients from 7/1/10 to 6/30/12. Patient demographics, procedural data, and outcomes were analyzed. The primary endpoint was all-cause mortality at 30-days post-CSD initiation.ResultsOf 208 patients who received CSDs, 31 (14.9%) experienced EVC: 13 (8.9%) of the 146 permanent VADs, 10 (26.3%) of the 38 temporary VADs, and 8 (33.3%) of the 24 ECMO patients. The 30-day mortality for CSD-EVC patients was not significantly higher than that of the CSD patients who did not experience EVC for permanent VAD (15.4% vs 4.5%; P = .15) and ECMO patients (50.0% vs 68.75%; P = 1.00), but was significantly higher for temporary VAD patients (80.0% vs 35.7%; P = .03). Within the CSD-EVC cohort, patients who received a temporary VAD had a significantly higher 30-day mortality and decision to withdraw care after EVC compared with those who received a permanent VAD (P = .01 and P < .01, respectively). Looking beyond the 30-day window, EVC was associated with higher mortality rates in the permanent VAD population (53.8% vs 25.6%; P = .025) but not the temporary VAD or ECMO groups.ConclusionsIn temporary VAD recipients, EVCs result in higher 30-day mortality, more frequent withdrawal of care, and shortened survival time relative to the global temporary VAD group. EVC in permanent VAD recipients did not affect early (30-day) mortality rates, but strongly predicted a higher cumulative mortality risk for the 2-year study period. Overall ECMO mortality rates were high, and not significantly impacted by the occurrence of EVC. The nature of the EVC (cannulation site complication vs embolic injury) did not impact mortality. This data provides quality improvement targets for VAD programs.

Purpose The progression of hemolysis to LVAD thrombosis is incompletely understood. Despite antiplatelet therapy and anticoagulation with coumadin, clot formation within LVADS occurs at a variable rate, leading to LVAD dysfunction and ultimately failure. Clot progression and anatomy is poorly defined. Understanding the location and structure of clot may help in its treatment and target prevention. Methods and Materials 266 Patients had HM2s placed between 2007-2012. Six devices were explanted and preserved specifically for pathologic analysis. HM2 were evaluated in 3 areas (inlet stator [IS], outlet stator [OS], rotor assembly [RA]). Tissues were with hematoxylin and eosin. Microscopic evaluation for cells including fibroblasts, macrophages, red cell and bacteria were performed. Results The average support time was 292±533 (34-1377) days. LDH prior to explant was 4434±3511 (703-8884). No cells were found at the core of any of the clots. All patients had both coumadin and aspirin therapy. [Table 1] [ figure 1 ] Conclusions Stator build-up occurs within 30 days of HM2 implantation. The microscopic structure is the same at the stator bearings, whether it was 34 days or 1377 days. This appears to be an interaction of heat and blood components as cells are absent at the core. RA clot has a similar concentric chronic layering found in the stator, suggesting that RA clot may be extension of the process on the stator bearing vs acute thrombus. Medical therapy targeting fibrin formation may lead to reduced fibrin load on the bearing and decease pump dysfunction. CLOT Support(Days) Inlet Stator Rotor Outlet Stator Fibrin Layering Pump 1 1377 Y N Y Y Pump 2 127 Y N Y Y Pump 3 66 Y Y N Y Pump 4 34 Y Y Y Y Pump 5 57 Y Y Y Y Pump 6 88 N N Y Y

Purpose While centers are implanting LVADs in patients from various geographies, the impact of patient geographic variables on LVAD outcomes is unknown. We analyzed individual patient geographic variables as possible risk factors adverse events. Methods and Materials 151 consecutive Heartmate II LVAD recipients from our center surviving implant hospitalization were reviewed for: home distance from implant center, average income of ZIP, rural code, hospital service area (HSA), IMACS class, age, sex, race, strategy (BTT vs DT), and implant date. A subset of 89 patients had full INTERMACS followup event data. Cox proportional hazards model for time to death and time to any event was used, censoring for transplant, adjusting for age, IMACS class, and strategy. Results There were 0.18 deaths/person-year (mean risk time 1.68 years) and 67.4% of patients had ≥ one event at mean time-to-event 159 days. Median distance from center was 42.9 miles with 29% rural patients and 66% living outside the HSA. There was no increased hazard for death or any event for any of the geographic variables examined. Conclusions LVAD recipients living farther away, rurally, outside the HSA, or in less-affluent ZIP codes do not appear to be at increased risk of death or adverse events. Any Event (Cox-Proportional Hazard) * Unadjusted HR (95% CI)Adjusted HR (95% CI)†Distance from Center0.999 (0.996-1.003)0.999 (0.995-1.002)AGI of ZIP (thousands)1.014 (0.992-1.037)1.016 (0.992-1.042)Rural Residence0.605 (0.336-1.090)0.612 (0.335-1.116)Lives outside Implant Center HSA0.701 (0.406-1.208)0.625 (0.356-1.095)*Death, Hospitalization, Bleed, Neurologic Event, Infection, Device Failure †Adjusted for Age, IMACS class, and Strategy Mortality (Cox-Proportional Hazard)Unadjusted HR (95% CI)Adjusted HR * (95% CI)Distance from Center0.988 (0.816-1.2)0.988 (0.81-1.21)AGI of ZIP (thousands)1.012 (0.983-1.042)1.013 (0.984-1.043)Rural Residence0.854 (0.448-1.625)0.855 (0.448-1.631)Lives outside Implant Center HSA0.616 (0.335-1.135)0.615 (0.332-1.141)*Adjusted for Age, IMACS class, and Strategy

Purpose Although the quality and durability of left ventricular assist device (LVAD) have been improved recently, device failure remains to be a serious issue with increased waiting time for bridge to transplant and improved survival in destination therapy. LVAD exchange can be done by full sternotomy for a radical revision or by a less-invasive subcostal approach. Either results of LVAD exchange or surgical techniques, however, are not well investigated. Methods and Materials Among 176 consecutive patients who had LVAD implantation between January 2008 and June 2012, total 16 patients underwent 17 pump exchanges. Eight had subcostal (SC group, n=8) approach and the rest had full sternotomy (FS group, n=9). Mortality, hospital stay, operation time, cardiopulmonary bypass time and amount of perioperative blood transfusion were analyzed. All data were prospectively collected for STS and institutional databases. Results Total 13 HeartMate II, 2 HVAD and 2 VentraAssist were used for pump exchange. Fourteen had pump failure due to thrombus and 3 had driveline failure. Post-operative 30-day mortality was 25% (3 FS, 1 SC) and 1-year mortality was 50% (5 FS, 3 SC) in the entire group. One year mortality in the SC group was significantly lower (33% vs. 63%, p Conclusions LVAD failure remains a devastating complication. Any pump exchange resulted in high mortality both in short and mid-term. SC approach provides a decreased OR time and a shorter recovery as well as improved one-year survival compared to the FS group. A better pre-operative optimization, earlier and less invasive surgical approach may help us achieve a better result in LVAD exchange.