Confirm Rx insertable cardiac monitor for primary atrial fibrillation detection in high-risk heart failure patients (Confirm-AF trial).

BACKGROUND: Patients with heart failure (HF) represent a large population of patients who are at high risk for complications related to undiagnosed atrial fibrillation (AF). However, currently there are limited modalities available for early AF detection in this high-risk population. An implantable cardiac monitor (ICM) is inserted subcutaneously and can provide long-term arrhythmia information via remote monitoring. METHODS AND RESULTS: Confirm-AF is a prospective randomized, nonblinded, two arm, multicenter clinical trial to be performed in the United States, enrolling 477 patients with a history of HF hospitalization and left ventricular ejection fraction >35% from 30 medical sites. Patients will be randomized in a 2:1 fashion to undergo ICM implant with remote monitoring and symptom-triggered mobile app transmissions versus (vs.) Non-ICM management and follow-up. The primary objective of this trial is to compare the time to first detection of AF lasting > 5 min using an Abbott ICM compared to non-ICM monitoring in symptomatic HF patients. This article describes the design and analytic plan for the Confirm-AF trial. CONCLUSIONS: The Confirm-AF trial seeks to accurately define the burden of AF in high-risk HF patients with LVEF > 35% using an Abbott ICM. A finding showing significantly higher incidence of AF along with improved clinical outcomes with ICM monitoring is expected to have substantial clinical implications and may change the method of monitoring high-risk HF patients.

Potential for donation after circulatory death heart transplantation in the United States: Retrospective analysis of a limited UNOS dataset.

Donation after Circulatory Death (DCD) is an alternative to Donation after Brain death (DBD), and is a growing strategy for organ procurement in the United States(US). The purpose of this analysis was to review the number and quality of hearts in one United Network for Organ Sharing (UNOS) Region that were not utilized as a potential consequence of nonheart DCD donation. We retrospectively identified all successful US DCD solid organ donors from 1/2011 to 3/1/2017, defined an ideal heart donor by age and left ventricular ejection fraction (LVEF), and then reviewed the donor charts of unused hearts in New York and Vermont (UNOS Region 9). Of 8302 successful DCD donors across the United States, 5033 (61%) were between 18 and 49 years of age, and 872 had a screening echocardiogram, with 573 (66%) measuring an EF >50%. Of these 573 potential donors, 44 (7.7%) were from Region 9. Detailed donor chart review identified 36 ideal heart donors, 24 (66.7%) with anoxic brain injury. Trends in Region 9 DCD donation increased from 4 unused hearts in 2011, to 13 in 2016. In the context of severe organ scarcity, these data indicate that implementation of DCD heart transplantation in the United States would improve overall donation rates and provide a pathway to utilize these ideal donor hearts.

A Multimodal Skin Cancer Prevention Program for Heart Transplant Patients.

BACKGROUND: Immunosuppressant medications are essential for long-term survival following transplantation but increase the risk of developing skin cancer. Prevention and early detection of skin cancer requires screening and sun protection behaviors that can be achieved with patient education. PROBLEM STATEMENT: Our method for educating post heart transplant patients regarding skin cancer was inconsistent and was not effective. The aim of this project was to develop and integrate a multimodal skin cancer education program to increase knowledge and protective behaviors for heart transplant recipients. METHODS: Twenty-five post heart transplant patients who were scheduled to be seen for routine posttransplant care at a single-center transplant center between October 26, 2016, and November 15, 2016, took part in a multimodal skin cancer education program. RESULTS: There was a significant increase in knowledge between pretest and posttest 1 ( P <.01) and pretest and posttest 2 ( P <.01). A significant increase in sun protective behavior was noted. The project noted that knowledge and behavior was retained, knowledge score posttest 1 to posttest 2 ( P = .085), all had seen a dermatologist or had an appointment scheduled, and self skin exam retention was noted between posttest 1 and posttest 2 ( P = .25). Process Addressed: The feasibility of and findings from this intervention have led the clinic team to implement this protocol as part of the standard care for all patients. CONCLUSIONS: These data suggests that a multimodal intensive skin cancer education program may be effective at increasing knowledge and protective behavior with heart transplant recipients.

Maximizing donor allocation: A review of UNOS region 9 donor heart turn-downs.

This study was performed to determine if organ selection practices for heart utilization by Region 9 transplant programs were optimal, and to identify opportunities to increase local organ recovery. A retrospective review of de-identified region-wide donor data January 1, 2010 through December 31, 2013 was performed. Over the study period 537 heart donors were identified, of which 321 (60%) were transplanted. Two hundred-sixteen consented hearts were not used; 190 of these were not recovered, and 26 were recovered but not transplanted. Of these, 245/321 (76%) hearts were transplanted at one of 5 regional programs, 15 (5%) were transplanted out of region as primary offers, and 61 (19%) were turned down in region and exported. Of the 61 exported hearts, 43 were turned down in region for donor-related "quality" codes (UNOS 830, 833-837) by at least one program, the remaining 18 hearts were turned down for non-"quality" reasons, primarily histocompatibility and size. Only 5/43 exported were turned down for "quality" reasons by all regional programs offered the organ. A review of consented, not recovered donor offers suggested an additional 28 organs were possibly appropriate for transplant. Our review of regional turn-downs suggests transplant centers could potentially identify additional usable organs without compromising short-term outcomes.

Study of the wearable cardioverter defibrillator in advanced heart-failure patients (SWIFT).

INTRODUCTION: The wearable cardioverter defibrillator (WCD) may allow stabilization until reassessment for an implantable cardioverter defibrillator (ICD) among high-risk heart failure (HF) patients. However, there are limited data on the WCD benefit in the acute decompensated HF setting. METHODS AND RESULTS: The Study of the Wearable Cardioverter Defibrillator in Advanced Heart Failure Patients (SWIFT) was a prospective clinical trial carried out at two medical centers. Patients hospitalized with advanced HF symptoms and reduced left ventricular ejection function (LVEF) were enrolled and prescribed a WCD prior to discharge for a total of 3 months. Outcome measures included arrhythmic events, WCD discharge, and death. Study patients (n = 75, mean age 51 ± 14 years, 31% women) had a mean LVEF of 21.5 ± 10.4%. Non-ischemic cardiomyopathy was present in 66% of patients. The median WCD wearing time was 59 (interquartile range 17-97) days, and 80% of patients wore the device >50% of daily hours. WCD interrogations showed a total of 8 arrhythmic events in 5 patients, including 3 nonsustained or self-terminating ventricular tachycardia (VT) events, and one polymorphic VT successfully terminated by the WCD. None of the patients died while wearing the device and no inappropriate device therapies occurred. Upon termination of treatment with the WCD, 21 patients (28%) received an ICD. At 3 years, the cumulative death rate was 20% in the ischemic and 21% in non-ischemic cardiomyopathy patients. CONCLUSION: A management strategy incorporating the WCD can be safely used to bridge the decision regarding the need for ICD implantation in high-risk patients with advanced HF.

Single-Center Experience With HeartMate II Left Ventricular Assist Device Explantation.

In patients with continuous flow left ventricular assist devices (CF-LVADs) myocardial recovery is uncommon. Given the heterogeneity of the population implanted and low incidence of recovery, the discovery of native left ventricular (LV) recovery and criteria for explantation of CF-LVAD system is not clearly determined. We sought to analyze the characteristics of the patients who underwent CF-LVAD explantation at our institution. Prospectively collected data on patients supported with CF-LVADs were reviewed retrospectively. Patients who underwent CF-LVAD explants were identified and their characteristics were analyzed with a focus on patient presentation and determinants of explantability. From November 2006 to June 2014, 223 patients (181 male, 42 female) underwent implantation of HeartMate II LVAD. Seven female (16.7%) and one male (0.6%) patients were explanted (P < 0.001). Mean age was 43 ± 9 years and etiology for cardiomyopathy was ischemic in three (37.5%) patients, nonischemic in four (50%) patients, and mixed in the one (12.5%) male patient of the cohort. Five (62.5%) patients presented acutely with significant hemolysis, and were found to have LV improvement as well as reduced, absent, or reversed diastolic flow velocities on echocardiography. Overall, mean lactate dehydrogenase level before explantation was 1709 ± 1168 U/L compared to the mean baseline level of 601 ± 316 U/L (P = 0.048). Mean LV ejection fraction (LVEF) improved from 17 ± 7% preimplant to 56 ± 11% pre-explantation (P < 0.001). Median number of days on CF-LVAD support was 870 (interquartile range, 209-975) while mean duration of follow-up after the CF-LVAD explantation was 276 ± 240 days. Mean LVEF dropped from 46 ± 19% postexplantation to 34 ± 10% during the most recent follow-up (P = 0.015). At our institution, patients who underwent LVAD explants were predominantly women with nonischemic cardiomyopathy. Clinical evidence of hemolysis and echocardiographic evidence of reduced or absent diastolic flow velocities were common findings in these patients. Over time, patient's native LV function declined in the absence of LVAD (after LVAD explantation). Significant challenges remain in predicting LV recovery and identifying those individuals who have recovered myocardial function significant enough to be explanted.

Factors Related to Pump Thrombosis With the Heartmate II Left Ventricular Assist Device.

BACKGROUND: Recent reports suggested that HeartMate II (HMII) thrombosis rates may be higher in implants after 2011. We characterize events at HMII centers (>100 HMII implants) whose device thrombosis rates are equivalent or lower than reported by INTERMACS. METHODS: Seven centers pooled implants from 2011 through June 2013 to examine pump thrombus and identify characteristics and clinical strategies that potentially mitigate the risk. A total of 666 patients (age 59 ± 13 years; 81% male) were studied (support duration: 13.7 ± 8.3 months, cumulative: 759 patient years). Median target INR was 2.25 (range 2.0 to 2.5), and median pump speed was 9200 rpm (range 8600 to 9600). Pump thrombus was suspected with clinical evidence (e.g., hemolysis, positive ramp test) requiring intervention (e.g., anticoagulation therapy, pump exchange) or patient death. RESULTS: Suspected pump thrombus occurred in 24/666 (3.6%) patients within three months of implant. At six months, 38/666 (5.7%) had suspected pump thrombus including 24 (3.6%) resulting in pump exchange or death. Stroke (hemorrhagic: 0.049, and ischemic: 0.048 events/patient year) and survival (six months: 88 ± 1%; 1 year: 81 ± 2%) were consistent with national averages. Suspected pump thrombus patients were younger (55 ± 13 vs. 59 ± 13, p = 0.046) and had more females (31.6% vs. 18.3%, p = 0.054). There was no difference in indication, etiology of heart failure, or body size. CONCLUSIONS: This analysis demonstrates low HMII thrombus events. Minimization of risk factors by uniform implant techniques and consistent post-op management may reduce device thrombosis. A larger scale multicenter evaluation may better elucidate the difference in thrombus events between centers.

The effect of weight loss on clinical outcomes in patients implanted with a cardiac resynchronization therapy device-A MADIT-CRT substudy.

BACKGROUND: There are no data regarding the effect of weight loss on clinical outcomes in patients undergoing cardiac resynchronization therapy. This study was designed to evaluate the effect of weight loss on clinical outcomes in patients implanted with a cardiac resynchronization therapy with defibrillator (CRT-D). METHODS AND RESULTS: The risk of heart failure (HF) or death, and of death alone, was compared between patients with and without weight loss of ≥2 kg or more at 1 year in the CRT-D arm of the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy (MADIT-CRT). Weight loss was observed in 170 of 994 patients (17%) implanted with a CRT-D. Multivariate analysis showed a significant increase in the risk of HF or death among patients with weight loss compared with those without weight loss (hazard ratio [HR] 1.82, 95% confidence interval [CI] 1.26-2.63; P = .001). Weight loss was associated with a 79% increase in the risk of all-cause mortality (HR 1.79, 95% CI 1.16-3.34; P = .01). When analyzed in a continuous fashion, each kg of weight loss was associated with a 4% increase in the risk of HF or death (P = .03). In left bundle branch block (LBBB) patients with a CRT-D, weight loss was associated with an especially high risk of HF or death (HR 2.23, 95% CI 1.36-3.65; P = .002) and of death alone (HR 2.33, 95% CI 1.07-5.06; P = .03; interaction P = .26). CONCLUSIONS: In patients with mild symptoms of HF receiving CRT-D, weight loss observed at 1 year is associated with adverse clinical outcomes, especially in those with a LBBB electrocardiographic pattern.

Risk of mortality for ventricular arrhythmia in ambulatory LVAD patients.

BACKGROUND: There are limited data regarding the incidence and prognostic significance of ventricular arrhythmias (VA) in ambulatory continuous flow left ventricular assist device (LVAD) patients. METHODS: Sixty-one consecutive patients from November 1, 2006 through December 31, 2010 with an LVAD and implantable cardioverter defibrillator that survived to discharge from the LVAD implantation admission were studied. Follow-up began from date of discharge with both devices in situ and ended with death, transplant, on June 1, 2011. Pre-LVAD VA history was related to the primary endpoints of post-LVAD VA, mortality, and the combined endpoint of post-LVAD VA/mortality. RESULTS: During a mean follow-up of 622 days 19 patients (31%) experienced VA (14 episodes of VT, 5 episodes of VF). Pre-LVAD VA was predictive of post-LVAD VA (hazard ratio [HR] 2.91, P = 0.026) and the combined post-LVAD VA/mortality endpoint (HR 2.70, P = 0.021) but only displayed a nonsignificant association with mortality (HR 2.30, P = 0.11). In multivariate analysis, pre-LVAD VA remained a significant predictor of post-LVAD VA (HR 2.84, P = 0.03) and the combined post-LVAD VA/mortality endpoint (HR 2.65, P = 0.025). Post-LVAD VA was the strongest univariate predictor of mortality (HR 13.92, P < 0.001) and remained so after multivariate adjustment (HR 9.69, P = 0.001). Post-LVAD VA occurred at a mean of 1 year from mortality events with 45% within 1 month. CONCLUSIONS: Pre-LVAD VA is a significant predictor of post-LVAD VA but not of mortality. VA in the continuous flow LVAD population carries a significant risk of mortality often within the first month.

Variability in Blood Pressure Assessment in Patients Supported with the HeartMate 3TM.

Targeted blood pressure (BP) control is a goal of left ventricular assist device medical management, but the interpretation of values obtained from noninvasive instruments is challenging. In the MOMENTUM 3 Continued Access Protocol, paired BP values in HeartMate 3 (HM3) patients were compared from arterial (A)-line and Doppler opening pressure (DOP) (319 readings in 261 patients) and A-line and automated cuff (281 readings in 247 patients). Pearson (R) correlations between A-line mean arterial (MAP) and systolic blood pressures (SBP) were compared with DOP and cuff measures according to the presence (>1 pulse in 5 seconds) or absence of a palpable radial pulse. There were only moderate correlations between A-line and noninvasive measurements of SBP (DOP R = 0.58; cuff R = 0.47) and MAP (DOP R = 0.48; cuff R = 0.37). DOP accuracy for MAP estimation, defined as the % of readings within ± 10 mmHg of A-line MAP, decreased from 80% to 33% for DOP ≤ 90 vs. >90 mmHg, and precision also diminished (mean absolute difference [MAD] increased from 6.3 ± 5.6 to 16.1 ± 11.4 mmHg). Across pulse pressures, cuff MAPs were within ±10 mmHg of A-line 62.9%-68.8% of measures and MADs were negligible. The presence of a palpable pulse reduced the accuracy and precision of the DOP-MAP estimation but did not impact cuff-MAP accuracy or precision. In summary, DOP may overestimate MAP in some patients on HM3 support. Simultaneous use of DOP and automated cuff and radial pulse may be needed to guide antihypertensive medication titration in outpatients on HM3 support.

Prediction of Survival After Implantation of a Fully Magnetically Levitated Left Ventricular Assist Device.

BACKGROUND: Clinical trials inform on average efficacy, but individualized risk assessments for outcome prediction are important in guiding treatment implementation. OBJECTIVES: The authors developed and validated a patient-specific risk score to predict survival at 1 and 2 years after HeartMate 3 (HM3) left ventricular assist device (LVAD) implantation. METHODS: The MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) trial includes 2,200 HM3 LVAD patients in the pivotal trial and Continued Access Protocol study (2014-2018). The authors randomly assigned all patients to a derivation cohort (n = 1,540) or validation cohort (n = 660). Univariate mortality predictors were screened for potential model inclusion, stepwise selection was used to build the multivariable Cox proportional hazards regression model, and performance (discrimination and calibration) was evaluated. RESULTS: Age, prior cardiac surgery (coronary artery bypass grafting [CABG] or valve procedure), lower serum sodium, higher blood urea nitrogen (BUN), small left ventricular size, and right atrial pressure-to-pulmonary capillary wedge pressure (RAP/PCWP) ratio >0.6 were significant risk factors for mortality. Receiver-operating characteristic (ROC) analysis in the validation cohort demonstrated an area under the curve (AUC) of 0.76 (95% CI: 0.70-0.81) at 1 year and 0.71 (95% CI: 0.66-0.77) at 2 years. Calibration between predicted and observed survival of the risk quintiles was high, with Pearson correlation coefficients of 0.986 and 0.994 at 1 and 2 years, respectively. Patients were successfully stratified into tertiles with higher-than-average, average, and lower-than-average survival, and observed mortality risk increased by 2-fold from one tertile to the next. CONCLUSIONS: A practical, easy-to-use HM3 Survival Risk Score with 6 components was developed to accurately predict 1- and 2-year survival after HM3 LVAD implantation. The survival risk score can be used to provide individual survival estimates to facilitate shared decision making when considering HM3 LVAD therapy. (MOMENTUM 3 Trial Portfolio; NCT02224755, NCT02892955).

Smoking and the Risk of Stroke in Patients with a Left Ventricular Assist device.

There are limited data on the association of smoking with the risk of stroke following left ventricular assist device (LVAD) implantation. We designed this study to analyze the impact of smoking status at the time of LVAD implantation on stroke. We hypothesized that current smokers are at increased risk of stroke when compared with patients who were former or never smokers. The study population comprised of 369 patients in the University of Rochester Medical Center LVAD database, implanted with an LVAD between 2008 and 2018. Patients were stratified as current smoker (smoking within 30 days before LVAD implantation), former smoker, and never smoker. Stroke was defined as a transient ischemic attack or cerebrovascular accident (hemorrhagic or ischemic). There were 45 current smokers, 198 former smokers, and 125 never smokers. Current smokers were younger (mean age 50 ± 11 years), as compared with former (58 ± 12 years) and never smokers (56 ± 13 years) p < 0.001. At 2 years following LVAD implantation, the cumulative incidence of stroke was significantly higher among current smokers (39%) as compared with former and never smokers (16% and 15%, respectively; p = 0.022 for the overall difference during follow-up). In a multivariate model adjusted for significant clinical variables, current smoking was associated with a significant 88% (p = 0.018) higher risk of stroke when compared with all noncurrent smokers. In conclusion, our data suggest that LVAD candidates who are current smokers experience a significantly higher risk of stroke following device implantation.

Renal and hepatic function improve in advanced heart failure patients during continuous-flow support with the HeartMate II left ventricular assist device.

BACKGROUND: The effects of continuous blood flow and reduced pulsatility on major organ function have not been studied in detail. METHODS AND RESULTS: We evaluated renal (creatinine and blood urea nitrogen) and hepatic (aspartate transaminase, alanine transaminase, and total bilirubin) function in 309 (235 male, 74 female) advanced heart failure patients who had been supported with the HeartMate II continuous-flow left ventricular assist device for bridge to transplantation. To determine whether patients with impaired renal and hepatic function improve over time with continuous-flow left ventricular assist device support or whether there are any detrimental effects in patients with normal organ function, we divided patients into those with above-normal and normal laboratory values before implantation and measured blood chemistry over time during left ventricular assist device support. There were significant improvements over 6 months in all parameters in the above-normal groups, with values in the normal groups remaining in the normal range over time. Mean blood urea nitrogen and serum creatinine in the above-normal groups decreased significantly from 37+/-14 to 23+/-10 mg/dL (P<0.0001) and from 1.8+/-0.4 to 1.4+/-0.8 mg/dL (P<0.01), respectively. There were decreases in aspartate transaminase and alanine transaminase in the above-normal groups from 121+/-206 and 171+/-348 to 36+/-19 and 31+/-22 IU (P<0.001), respectively. Total bilirubin for the above-normal group was 2.1+/-0.9 mg/dL at baseline; after an acute increase at week 1, it decreased to 0.9+/-0.5 mg/dL by 6 months (P<0.0001). Both renal and liver values from patients in the normal groups remained normal during support with the left ventricular assist device. CONCLUSIONS: The HeartMate II continuous-flow left ventricular assist device improves renal and hepatic function in advanced heart failure patients who are being bridged to transplantation, without evidence of detrimental effects from reduced pulsatility over a 6-month time period.

Long-term milrinone therapy as a bridge to heart transplantation: Safety, efficacy, and predictors of failure.

BACKGROUND: Studies of long-term inotrope use in advanced HF have previously provided limited and conflicting results. This study aimed to evaluate the safety and efficacy of long-term milrinone use and identify predictors of failure to bridge to orthotropic heart transplant (OHT) in a cohort of end-stage heart failure (HF) patients listed for heart transplantation and receiving inotrope therapy. METHODS: The study included 150 adults listed for OHT at a single center from 2001 to 2017 who received milrinone therapy for ≥30 days. Multivariate Cox proportional hazards models were used to identify factors associated with "failure" (left ventricular assist device, intra-aortic balloon pump, status downgrade due to instability, death) vs. "success" (OHT, recovery) during bridging to OHT. RESULTS: "Failure" occurred in 33 (22%) patients. Factors independently associated with failure included male sex (HR = 7.6; p = 0.004), no implantable cardioverter-defibrillator (HR = 3.8; p = 0.009), and lack of guideline-directed medical therapy (GDMT) with a beta-blocker (HR = 7.8; p = 0.002) or angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (HR = 6.3; p < 0.001). Patients who received fewer guideline-directed medications had a higher cumulative probability of failure. Adverse events included central line-associated bloodstream infection (2.55 per 1000 line-days) and arrhythmia (1.59 per 1000 treatment-days). CONCLUSIONS: Our findings suggest that long-term milrinone therapy in selected patients is associated with a high rate of successful bridging to OHT and a low rate of adverse events. Patients intolerant of GDMT are more likely to fail to bridge to OHT without mechanical support. Sex differences in outcomes associated with milrinone therapy should be explored.

Association of previous cardiac surgery with outcomes in left ventricular assist device patients.

OBJECTIVES: History of prior cardiac surgery has traditionally been considered a risk factor for subsequent cardiac procedures. The aim of this study was to investigate the outcomes of patients implanted with a left ventricular assist device via redo sternotomy. METHODS: Prospectively collected data were reviewed for all patients implanted with a continuous-flow left ventricular assist device at a single institution from December 2006 through June 2018. Patients were separated into 2 cohorts: those with a history of prior cardiac surgery (redo sternotomy) and those undergoing primary sternotomy at the time of left ventricular assist device implantation. The primary outcome was overall survival. RESULTS: Of the 321 patients included in the study, 77 (24%) were implanted via redo sternotomy and 244 (76%) via primary sternotomy. The redo sternotomy cohort was generally older (59 ± 10 vs 57 ± 12 years, P = 0.050) and had a higher incidence of ischaemic disease (70% vs 49%, P = 0.002). The Kaplan-Meier survival analysis demonstrated that overall survival was not significantly different between the redo sternotomy and primary sternotomy groups (6-month survival: 86% vs 92%; 5-year survival: 53% vs 51%; log-rank P = 0.590 for overall difference during follow-up). The propensity score analysis consistently showed that redo sternotomy was not significantly associated with mortality risk (hazard ratio 1.19, 95% confidence interval 0.73-1.93; P = 0.488). Redo sternotomy patients were more likely to require rehospitalization during their first year postoperatively (P = 0.020) and spent less time out of the hospital during the first year (P = 0.046). CONCLUSIONS: The redo sternotomy cohort represents a more technically challenging patient population, but overall survival similar to that of primary sternotomy patients can be achieved.

Complete Sternal-Sparing Approach Improves Outcomes for Left Ventricular Assist Device Implantation in Patients With History of Prior Sternotomy.

OBJECTIVE: Early reports of less invasive techniques for left ventricular assist device (LVAD) implantation have demonstrated promising results. We sought to investigate the safety and feasibility of implementing the complete sternal-sparing (CSS) approach for LVAD implantation in patients with a history of prior cardiac operation. METHODS: This was a retrospective review of prospectively collected data for all patients implanted with a fully magnetically levitated LVAD from April 2017 through December 2018. Patients were dichotomized based on surgical approach: CSS or full median sternotomy (FS). Perioperative complications and overall survival were compared between cohorts. RESULTS: Of the 29 eligible patients, 15 (52%) were implanted via the CSS approach and 14 (48%) via FS. Preoperative characteristics were similar between cohorts. Overall survival to discharge was 93% for CSS compared to 71% for FS (P = 0.169). The CSS cohort demonstrated fewer postoperative complications, including fewer cases of severe right ventricular failure (P = 0.006) and less blood product utilization (P = 0.015). Median hospital length of stay was significantly shorter for the CSS cohort (median 13 vs 32.5 days, P = 0.016). Neither cohort had any 30-day readmissions. CONCLUSIONS: Early data suggest that the CSS technique is a safe and effective technique for patients with a history of prior sternotomy. Further studies are needed to validate this single-center experience.

Outcomes of gastrointestinal bleeding in patients with left ventricular assist devices: a tertiary care experience.

Background and study aims Left ventricular assist device (LVAD) placement is a therapeutic modality for patients with end-stage heart failure. Gastrointestinal bleeding is a common complication following LVAD implantation. The aim of this study was to report our experience in management and outcomes of gastrointestinal bleeding in a large cohort of patients with LVADs. Patients and methods We performed a retrospective review of all patients who underwent LVAD implantation at the University of Rochester Medical Center from January 2008 to June 2017. Data were collected on patient characteristics, clinical aspects of gastrointestinal bleeding events, and procedural interventions. A Cox proportional hazard model was utilized to identify potential risk factors for a gastrointestinal bleeding event. Results During the study period, 345 patients underwent LVAD implantation. Of these, 125 patients (36.2 %) experienced 297 gastrointestinal bleeding events resulting in 533 endoscopic procedures. The diagnostic yield of endoscopy in determining a bleeding source was 49.5 %. If required, therapeutic interventions were successful in achieving homeostasis in 96.2 % of procedures. Our 30-day overall post-procedure adverse event (AE) rate was 6.6 %. Procedure-related (bleeding, infection, and perforation) AEs were very minimal (2.8 %). A Cox proportional hazard model indicated that older age at implant, female sex, African-American race, diabetes mellitus, and pulmonary hypertension were statistically significant predictors of a gastrointestinal bleeding event following LVAD implantation. Conclusions LVAD patients have a high risk of gastrointestinal bleeding. Endoscopy was able to safely locate a bleeding lesion in approximately half of our patients and was successful in treating bleeding lesions in a majority of the cases.

Effect of gender on cardiovascular risk stratification with ECG gated SPECT left ventricular volume indices and ejection fraction.

BACKGROUND: Optimal gender-specific risk prediction using ECG-gated SPECT left ventricular (LV) volumes and ejection fraction (EF) remains undefined despite reported gender differences in baseline LV function. METHODS: ECG-gated SPECT studies of 891 consecutively referred patients (43% women) were evaluated for LV end-systolic and diastolic volume indices (ESVI, EDVI) and EF. Effects of gender on prediction of hard cardiac events (HCE) and the combined endpoint of all-cause mortality or non-fatal infarction (ACMMI) were evaluated. RESULTS: Women had smaller ESVI (37 vs 55 mL/m(2)), EDVI (78 vs 99 mL/m(2)), and higher LVEF (56 vs 47%, P < 0.0001 for each) with equivalent rates of HCE (6.1%) and ACMMI (11.8%). HCE risk started at smaller ESVI and EDVI in women compared to men (P < or = 0.05 for each). In women, ESVI 37 mL/m(2) provided maximum HCE prediction compared to 53 mL/m(2) in men. A 1 mL/m(2) increase in ESVI was associated with a 2.9% increased HCE risk in women (P < 0.0001) and a 0.9% increased ACMMI risk in men (P = 0.03). Women with ESVI > 35 mL/m(2) had HCE HR 12.0 compared to women with ESVI < 23 mL/m(2). CONCLUSION: LV volume indices and LVEF predict subsequent morbid clinical events in men and women. In women, risk of subsequent events started at smaller LV volume indices compared to men despite similar risk profiles.