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Background Women differ from men in their left ventricular (LV) structure, function and remodeling with age and diseases. The LV assist device (LVAD) unloads the LV and reversely remodels the heart. We sought to define the effects of sex on longitudinal reverse remodeling after LVAD implantation. Methods and Results Cardiac structure and function were assessed by serial echocardiograms. Mixed effect regression models were constructed to assess the independent contribution of sex to longitudinal changes in cardiac structure and function. A total of 355 consecutive patients with advanced heart failure received continuous flow LVADs between 2006 and 2016. The average age was 56 ± 13 years, 73% were men, and 67% were black. Early (within 3 months) after LVAD implantation, women had a greater reduction in LV dimensions and a greater increase in LV ejection fraction compared with men. These differences were independent of age, body surface area, device type, or ischemic etiology of heart failure. At long-term follow-up, LV dimensions increased slightly over time in women compared with men, but overall, earlier changes were maintained. Conclusion Women had significantly more favorable longitudinal changes in cardiac structure and function in response to LV unloading compared with men. Understanding the cause of sex difference in reverse remodeling after LVAD may help to devise novel therapeutic strategies for women with advanced heart failure.

Left ventricular assist devices (LVADs) improve quality of life (QoL) and functional capacity (FC) for patients with advanced heart failure. The association between adverse events (AEs) and changes in QoL and FC are unknown. Patients treated with the HeartWare ventricular assist device (HVAD) with paired 6-minute walk distance (6MWD, n = 263) and Kansas City Cardiomyopathy Questionnaires (KCCQ, n = 272) at baseline and 24 months in the ENDURANCE and ENDURANCE Supplemental Trial databases were included. Patients were stratified based upon occurrence of clinically significant AEs during the first 24 months of support and analyzed for the mean change in 6MWD and KCCQ. The impact of AE frequency on change in 6MWD and KCCQ from baseline to 24 months was evaluated. Of the AEs examined, only sepsis was associated with an improvement in 6MWD (109 m vs. 16 m, p = 0.002). Patients without improvement in 6MWD test from baseline to 24 months had significantly more AEs than those with FC improvement (p = 0.0002). Adverse events did not affect the KCCQ overall summary score. In this analysis, patients with fewer AEs had greater improvement in FC during the 24-month follow up. The frequency of AEs did not have a significant impact on QoL after LVAD implantation.

BackgroundMechanical circulatory support with a left ventricular assist device (LVAD) is an established treatment for patients with advanced heart failure. We compared a newer LVAD design (a small intrapericardial centrifugal-flow device) against existing technology (a commercially available axial-flow device) in patients with advanced heart failure who were ineligible for heart transplantation. MethodsWe conducted a multicenter randomized trial involving 446 patients who were assigned, in a 2:1 ratio, to the study (centrifugal-flow) device or the control (axial-flow) device. Adults who met contemporary criteria for LVAD implantation for permanent use were eligible to participate in the trial. The primary end point was survival at 2 years free from disabling stroke or device removal for malfunction or failure. The trial was powered to show noninferiority with a margin of 15 percentage points. ResultsThe intention-to treat-population included 297 participants assigned to the study device and 148 participan...

The Ventricular Assist Device for the Treatment of Advanced Heart Failure (ADVANCE) Bridge to Transplant (BTT) trial was a multicenter, prospective trial of the HeartWare Ventricular Assist Device (HVAD). The performance of the HVAD in various demographic sub-groups was evaluated.Baseline characteristics, adverse events, and survival were compared for men vs. women and whites vs. non-whites in the combined ADVANCE BTT and continued access protocol trial. Of 332 patients enrolled in these trials, 236 were men and 96 women, with 228 whites and 104 non-whites.At baseline, women had a smaller body surface area (1.8 ± 0.2 vs. 2.1 ± 0.3 m2, p0.0001), less hypertension (50.0% vs. 61.9%, p = 0.05), and less ischemic cardiomyopathy (15.6% vs. 45.3%, p0.0001). Differences in Kaplan-Meier survival were not significant at 180 days (men, 91.8%; women, 91.7%) and 1 year (men, 85.3%; women, 85.1%) despite adjustment for baseline differences. Men had a lower incidence of early right heart failure and renal and respiratory dysfunction, and a shorter length of stay. In the analysis by race, non-whites were younger than whites and had less ischemic heart failure, more hypertension, and lower creatinine levels at baseline. Non-whites had lower rates of arrhythmia, bleeding requiring rehospitalization, and device malfunctions than whites. Survival was high in non-whites and whites, at 94.1% vs. 90.4% at 180 days and 89.2% vs. 82.8% at 1 year, respectively, despite adjustment for baseline differences.Although heart failure etiology differed between men and women and between whites and non-whites, sex and race were not factors that affected survival in patients receiving the HVAD as BTT, which was high in all sub-groups.

Objectives:To review left ventricular assist device physiology, initial postoperative management, common complications, trouble shooting and management of hypotension, and other common ICU problems.Data Source:Narrative review of relevant medical literature.Data Synthesis:Left ventricular assist dev

Purpose The ENDURANCE Supplemental Trial (DT2) was designed to prospectively study whether improved blood pressure management would reduce the incidence of strokes in destination therapy patients receiving an HVAD. The trial not only demonstrated a significant reduction in hemorrhagic strokes, but also some reductions in stroke-related severity. This analysis seeks to study further the impact of stroke severity on 2-year survival in both the HVAD and control cohorts of DT2. Methods A retrospective analysis was performed on DT2 patients to identify those who experienced a stroke within 2 years of device implant. Strokes were defined as a focal neurological deficit with an associated finding on computed tomography. Modified Rankin Scale (mRS) was performed by a neurologist at presentation. MRS scores were labeled as Minor (mRS 0 - 3, non-disabling) or Major (mRS 4 - 6, disabling). Survival was calculated using Kaplan-Meier analysis. Time 0 was the date of a patient's first stroke post-implant. Results Of the 465 patients enrolled in DT2 (157 control, 308 HVAD), strokes within 2 years of implant were identified in 107 patients, 34 control (19 Minor, 15 Major), and 74 HVAD (46 Minor, 28 Major). The survival analysis following first stroke onset revealed a significant difference in survival rates (p Conclusion Analysis of post-stroke survival by severity in the ENDURANCE Supplemental Trial revealed better 2-year survival in patients with non-disabling versus disabling stroke. Conversely, survival rates within the control cohort appeared similar regardless of severity, although the sample size was small. HVAD patients with a non-disabling stroke appeared to have a higher 2-year survival rate compared to the control cohort.

Purpose Continuous flow ventricular assist devices (CFVAD) are increasingly being used in pediatric patients. We present our technique using preoperative virtual fit using 3D imaging and intraoperative 3D printed CFVAD model to assess fit in pediatric patients. Methods 3D imaging was used to assess chamber cavity size relative to the CFVAD. Additionally a novel 3D printed CFVAD model designed in SolidWorks (Waltham, MA) was printed with biocompatible material (Figure 1A) was used intraoperatively to assess fit. The model inflow was used to limit inflow projection as desired using Teflon washers (Figure 1B). The washers were telescoped on the model inflow with the sewing ring and fixed with four interrupted 3-0 prolene sutures to avoid malalignment, and ease the use of the coring device and CFVAD implantation. Results 3 patients (2-non compaction cardiomyopathy, 1-transplant graft dysfunction) underwent CFVAD implantation (2 LVAD and 1 BiVAD) using these techniques. Intrathoracic fit was obtained by incising the pleuropericardial folds, release of hemidiaphragm or remodeling of anterior chest wall (for RVAD). As predicted by the model, sternal closure could only be achieved after costal cartilage and rib segment resection in 1 patient who needed BiVAD. Postoperative VAD flows were satisfactory in all patients. Conclusion Combination of preoperative virtual fit assessment using 3D imaging and intraoperative fit using 3D printed model of VAD can be used to accurately determine fit of adult CFDs in pediatric patients. The 3D model is useful in tailoring the maneuvers needed to achieve uncomplicated intracardiac, intrapericardial and intrathoracic fit and sternal closure.

The use of long-term left ventricular assist devices (LVADs) has revolutionized the treatment of end-stage heart failure. The most significant advance in this field has been the longer durability of devices secondary to a simpler pump design with fewer or no mechanical bearings and valves. Continuous-flow LVADs have recently been shown to provide safe and effective circulatory support and have replaced the first-generation fill-to-empty devices. The Thoratec HeartMate II and the HeartWare HVAD are currently the 2 most commonly implanted LVADs worldwide. As LVAD technology moves forward and new miniaturized, more durable, and reliable pumps are being developed, the number of recipients who will benefit from this technology continues to grow. Elimination of the driveline with fully implantable pumps, implantation of miniature pumps with minimally invasive surgical techniques, wireless data transmission, and improved patient selection will further transform this field in the next few years.

The incorporation of complex medical device technologies into clinical practice is governed by critical oversight of the US Food and Drug Administration. This regulatory process requires a judicious balance between assuring safety and efficacy, while providing efficient review to facilitate access to innovative therapies. Recent contrasting views of the regulatory process have emphasized the difficulties in obtaining an optimal balance. Mechanical circulatory support has evolved to become an important therapy for patients who have advanced heart failure with the advent of more durable, implantable ventricular assist devices. The regulatory oversight of these new technologies has been difficult owing to the complexities of these devices, associated adverse event profile, and severity of illness of the intended patient population. Maintaining a regulatory environment to foster efficient introduction of safe and effective technologies is critical to the success of ventricular assist device therapy and the health of patients with advanced heart failure. Physicians representing key surgical and cardiology societies, and representatives from the Food and Drug Administration, National Heart, Lung, and Blood Institute, Centers for Medicare and Medicaid Services, Interagency Registry of Mechanically Assisted Circulatory Support, and industry partners gathered to discuss relevant issues regarding the current regulatory environment assessing ventricular assist devices. The goal of the meeting was to explore innovative ways to foster the introduction of technologically advanced, safe, and effective ventricular assist devices. The following summary reflects opinions and conclusions endorsed by The Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, Heart Failure Society of America, International Society for Heart and Lung Transplantation, and Interagency Registry of Mechanically Assisted Circulatory Support.

The incorporation of complex medical device technologies into clinical practice is governed by critical oversight of the US Food and Drug Administration. This regulatory process requires a judicious balance between assuring safety and efficacy, while providing efficient review to facilitate access to innovative therapies. Recent contrasting views of the regulatory process have emphasized the difficulties in obtaining an optimal balance. Mechanical circulatory support has evolved to become an important therapy for patients with advanced heart failure with the advent of more durable, implantable ventricular assist devices. The regulatory oversight of these new technologies has been difficult owing to the complexities of these devices, associated adverse event profile, and severity of illness of the intended patient population. Maintaining a regulatory environment to foster efficient introduction of safe and effective technologies is critical to the success of ventricular assist device therapy and the health of patients with advanced heart failure. Physicians representing key surgical and cardiology societies, and representatives from the Food and Drug Administration, National Heart, Lung, and Blood Institute, Centers for Medicare and Medicaid Services, Interagency Registry of Mechanically Assisted Circulatory Support, and industry partners gathered to discuss relevant issues regarding the current regulatory environment assessing ventricular assist devices. The goal of the meeting was to explore innovative ways to foster the introduction of technologically advanced, safe, and effective ventricular assist devices. The following summary reflects opinions and conclusions endorsed by The Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, Heart Failure Society of America, International Society for Heart and Lung Transplantation, and the Interagency Registry of Mechanically Assisted Circulatory Support.

While multi-detector cardiac computed tomography angiography (MDCCTA) prior to reoperative cardiac surgery (RCS) has been associated with improved clinical outcomes, its impact on hospital charges and length of stay remains unclear. We studied 364 patients undergoing RCS at Washington Hospital Center between 2004 and 2008, including 137 clinically referred for MDCCTA. Baseline demographics, procedural data, and perioperative outcomes were recorded at the time of the procedure. The primary clinical endpoint was the composite of perioperative death, myocardial infarction (MI), stroke, and hemorrhage-related reoperation. Secondary clinical endpoints included surgical procedural variables and the perioperative volume of bleeding and transfusion. Length of stay was determined using the hospital’s electronic medical record. Cost data were extracted from the hospital’s billing summary. Analysis was performed on individual categories of care, as well as on total hospital charges. Data were compared between subjects with and without MDCCTA, after adjustment for the Society of Thoracic Surgeons score. Baseline characteristics were similar between the two groups. MDCCTA was associated with shorter procedural times, shorter intensive care unit stays, fewer blood transfusions, and less frequent perioperative MI. There was additionally a trend towards a lower incidence of the primary endpoint (17.5 vs. 24.2 %, p = 0.13) primarily due to a lower incidence of perioperative MI (0 vs. 5.7 %, p = 0.002). MDCCTA was also associated with lower median recovery room [$1,325 (1,250–3,302) vs. $3,217 (1,325–5,353) p

Advanced heart failure patients who are classified as bridge to transplant (BTT) often remain on mechanical circulatory support (MCS) for long durations because of the limited supply of donor organs. Here, we present the outcomes of patients who have been supported by the HeartWare ventricular assist device system for more than 2 years. In the HeartWare BTT and continued access protocol trial, 74 of the 382 total patients (19.4%) had more than 2 years of MCS with a mean time of 1,045 days on device. The long-term group was more frequently female, was nonwhite, and had Interagency Registry for Mechanically Assisted Circulatory Support profiles 4-7. Postimplant adverse event rates including bleeding, cardiac arrhythmia, infection, stroke, renal dysfunction, and right heart failure were less frequent in the long-term cohort. In addition, the long-term cohort displayed significant improvements in Kansas City Cardiomyopathy Questionnaire Overall Summary Score, EuroQOL-5D Overall Health State Score, and 6 minute walk scores from baseline values. The rate of heart transplantation was lower for the long-term cohort, which may have been a result of their sex and blood type. However, most of these patients are still listed for cardiac transplantation and maintained their quality of life profiles through 3 years of support.

Background Patients with severe aortic stenosis (AS) and prior cardiac surgery undergoing aortic valve replacement (AVR) are at high risk. Transapical AVR might reduce the risk in patients not suitable for the transfemoral approach. We aimed to describe the fluoroscopy and left anterior descending artery (LAD) angiography guidance technique for transapical AVR access and the initial related procedural results. Methods Patients with severe AS and prior cardiac surgery undergoing transapical AVR using LAD angiographic-guided apical puncture were analyzed ( n =9). Additional guidance was added to the standard technique as follows. Minithoracotomy was performed at the level of the intercostal space in closer relationship to the apex identified by fluoroscopy. LAD angiography was performed at the time that the area of interest was recognized by radiopaque marker to ensure puncture lateral to the LAD. Apical needle puncture was performed under fluoroscopy guidance directed towards the aortic root. Results The population had a mean age of 83 years and was more frequently male (89%) with a high-risk profile (mean Society of Thoracic Surgeons score of 11%). Two patients received the 23-mm Edwards SAPIEN valve, and seven patients received the 26-mm SAPIEN device. All nine patients underwent successful implantation of transcatheter aortic valves with virtual abolishment of transaortic gradient, without procedural complications. Conclusion Fluoroscopy and angiography for guidance of the transapical approach facilitate a safe and rapid access to the apex, insuring no risk of damage to the LAD or to large diagonals.

Background and Purpose— Stroke development is a major concern in patients undergoing coronary artery bypass grafting (CABG). Whether asymptomatic severe carotid artery stenosis (CAS) contributes to the development of stroke and mortality in such patients remains uncertain. Methods— A retrospective analysis of 878 consecutive patients with documented carotid duplex ultrasound who underwent isolated CABG in our institution from January 2003 to December 2009 was performed. Patients with severe CAS (n=117) were compared with those without severe CAS (n=761) to assess the rates of stroke and mortality during hospitalization for CABG. The 30-day mortality rate was also assessed. Results— Patients with severe CAS were older and had a higher prevalence of peripheral arterial disease and heart failure. Patients with severe CAS had similar rates of in-hospital stroke (3.4% versus 3.6%; P =1.0) and mortality (3.4% versus 4.2%; P =1.0) compared with patients without severe CAS. The 30-day rate of mortality was also similar between the 2 cohorts (3.4% versus 2.9%; P =0.51). Conclusions— Severe CAS alone is not a risk factor for stroke or mortality in patients undergoing CABG. The decision to perform carotid imaging and subsequent revascularization in association with CABG must be individualized and based on clinical judgment.

Heparin-induced thrombocytopenia (HIT) is an immunemediated adverse drug event in which antibodies to the platelet-factor-4 (PF4)/heparin complex are produced, resulting in platelet activation and amplified thrombin production. Patients with HIT are at extremely high risk of thrombosis, and prompt initiation of an alternative anticoagulant is recommended to prevent thrombosis, limb amputation, or death [1]. The US Food and Drug Administration (FDA) has approved three direct thrombin inhibitors (DTIs; argatroban, lepirudin, and bivalirudin) for the prevention and/or treatment of thrombosis in patients with HIT (bivalirudin is only approved in patients undergoing percutaneous coronary intervention), but no randomized clinical trials have been conducted with these agents in patients with HIT. Their approval for use in the HIT setting was based on single-arm, historically controlled studies classified as lowquality evidence (i.e., evidence Level C) by the current American College of Chest Physicians Evidence-Based Clinical Practice Guidelines [1]. Comparisons of safety and efficacy data across studies are also difficult owing to fundamental differences in inclusion criteria, duration of treatment, and observation period. For example, a clinical diagnosis or a history of HIT was sufficient for inclusion in the argatroban trials (e.g., a fall in platelet count of 50% without serologic evidence), whereas, patients in the lepirudin trials were required to have serologically confirmed HIT prior to enrollment. The clinical community clearly would prefer to evaluate new technologies based on head-to-head, comparative data from appropriately powered, multicenter, double-blind, randomized clinical trials (i.e., evidence Level A). However, in the case of complex and relatively rare disorders, such as HIT, this approach may be unrealistic. We attempted to conduct the first randomized clinical trial of DTIs in patients with HIT. The purpose of this article is to discuss our experience in the design and execution of the PREVENT-HIT trial [2] and highlight issues of importance to the thrombosis community when evaluating the development of new agents for this serious adverse drug reaction. The PREVENT-HIT (NCT00787332) trial was an openlabel, multicenter study designed to evaluate the clinical and economic utility of twice-daily fixed-dose desirudin administered subcutaneously (SC) compared with a continuous infusion of activated partial thromboplastin time (aPTT)-adjusted argatroban to prevent or treat thrombosis in patients with suspected HIT. Although, we planned to enroll 120 patients, just 16 were randomized over 14 months, at a cost of more than $3 million. The study was stopped in December 2009 owing to poor enrollment. The results of the PREVENT-HIT study have been reported elsewhere [2] and are briefly summarized here. Sixteen patients were randomized to treatment with fixeddose desirudin (15 or 30 mg, depending on the absence or presence of thrombosis, respectively) SC every 12 h or with aPTT–adjusted argatroban administered by intravenous (IV) infusion. The primary efficacy measure was the composite of new or worsening thrombosis (objectively documented), amputation, or death. Secondary outcomes included major and minor bleeding while on study drug, time to platelet count recovery, and pharmacoeconomics. No amputations or deaths occurred. One patient randomized S. W. Boyce (&) Advanced Heart Failure Program, Department of Cardiac Surgery, Washington Hospital Center, Medstar Heart Institute, 110 Irving Street N.W., Suite 1E3, Washington, DC 20815-6048, USA e-mail: steven.w.boyce@medstar.net

Because of an extreme risk for thromboemboli, patients with suspected heparin-induced thrombocytopenia (HIT) require immediate initiation of an alternative anticoagulant. The only therapies approved by the Food and Drug Administration require intravenous infusion of expensive direct thrombin inhibitors. This prospective, randomized, open-label, exploratory study compared the clinical and economic utility of subcutaneous desirudin vs argatroban, the most frequently used agent for suspected or immunologically confirmed HIT, with or without thrombosis. Sixteen patients were randomized to treatment with fixed-dose desirudin (15 or 30 mg) every 12 hours or activated partial thromboplastin time-adjusted argatroban by intravenous infusion. Arm A included 8 patients naive to direct thrombin inhibitor therapy, whereas Arm B included 8 patients on argatroban for at least 24 hours before randomization. The primary efficacy measure was the composite of new or worsening thrombosis (objectively documented), amputation, or death. Other end points included major and minor bleeding while on drug therapy, time to platelet count recovery, and pharmacoeconomics. No amputations or deaths occurred. One patient randomized to argatroban had worsening of an existing thrombosis. Major bleeding occurred in 2 patients on argatroban and in none during desirudin treatment. There was 1 minor bleed in each treatment group. The average medication cost per course of treatment was $1688 for desirudin and $8250 for argatroban. Desirudin warrants further study as a potentially cost-effective alternative to argatroban in patients with suspected HIT.

Cardiac computed tomography (CT) allows the surgeon to create a pre-operative “road map” to mitigate morbidity from surgical re-entry prior to reoperative cardiac surgery (RCS). There are few prospective data on cardiac CT and RCS because previous data on CT were based on retrospective

Background: Early readmission after coronary artery bypass grafting (CABG) is an expensive adverse outcome. Although the perioperative experience of high-risk CABG patients has been studied extensively, little attention has been paid to low-risk CABG patients. The primary goal of this study was to identify the preoperative characteristics and to define risk predictors of readmission and preventive factors for readmission in low-risk isolated-CABG patients.Methods: We identified 2157 patients who underwent CABG between January 2000 and December 2005 at Washington Hospital Center, Washington, DC, and defined as low risk patients who had a Parsonnet bedside risk score lower than the 25th percentile. Patients who were rehospitalized within 30 days after surgery were compared with those who were not rehospitalized during this period.Results: The overall readmission rate for this study cohort was 6.3%. Compared with non-readmitted patients, early-readmitted patients were more likely to have diabetes mellitus (27.94% versus 20.88%, P = .05) and less likely to have hypertension (42.65% versus 51.36%, P = .05). Blood product transfusion (P < .01), postoperative length of intensive care unit stay (P = .01), and length of hospital stay (P = .05) were all significantly increased in the readmitted patients. The use of ?-blockers (P = .03) and angiotensin-converting enzyme inhibitors (P = .04) was significantly lower at discharge in this group of patients; however, multivariate regression analysis demonstrated diabetes (odds ratio, 1.59; 95% confidence interval, 1.08-2.42) to be the only independent predictor of early readmission.Conclusions: For low-risk CABG patients, diabetes mellitus is the risk predictor of early readmission. Early discharge was not associated with early readmission.

Objective: Postoperative vasoplegic syndrome (PVS) is a potentially lethal condition with increased mortality and other postoperative morbidities.Many previous studies have examined the outcomes associatedwith on-pump coronaryartery bypass grafting (CABG) surgery, little is known about the incidence of PVS after off-pump CABG. Methods: From November 21, 2005 to June 9, 2006, 334 patients underwent isolated onpump CABG and 362 had off-pump CABG surgery. Perioperative variables were retrospectively compared between on-pump and off-pump CABG surgery using univariate analysis. Significant variables were included into a stepwise regression model to ascertain their independent impact on the incidence of PVS. Results: The incidence of PVS in isolated on-pump CABG was 6.9%; in off-pump CABG was 2.8% (p = 0.01). However, in multivariable models adjusted for confounders, on-pump CABG did not reach statistical significance as a risk factor of PVS (OR = 2.3, 95% CI 0.94— 5.78; p = 0.07). In on-pump CABG, preoperative left ventricular EF less than 35% (OR = 3.6; p = 0.02) and increased body mass index (OR = 1.1; p = 0.04) were identified as risk predictors of PVS; whereas elective surgery (OR = 0.2; p = 0.02) and preoperative use of b-blockers (OR = 0.21; p = 0.02) were associated with a decreased rate of PVS. PVS was associated with longer ICU stay (OR = 6.0; p < 0.01), postoperative ventilation (OR = 4.6; p < 0.01), and hospital stay (OR = 2.62; p = 0.03). There was a stronger association between preoperative ACE inhibitors therapy and increased risk of PVS in off-pump CABG surgery (OR = 4.52, 95% CI 0.95—21.67; p = 0.06) than in on-pump CABG surgery (OR = 1.06, 95% CI 0.35— 3.19; p = 0.91), but neither of them reaches statistical significance. Conclusions: The incidence of PVS after off-pump CABG surgery was significantly lower than after on-pump CABG surgery. # 2008 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

background Valdecoxib and its intravenous prodrug parecoxib are used to treat postoperative pain but may involve risk after coronary-artery bypass grafting (CABG). We conducted a randomized trial to assess the safety of these drugs after CABG. methods In this randomized, double-blind study involving 10 days of treatment and 30 days of follow-up, 1671 patients were randomly assigned to receive intravenous parecoxib for at least 3 days, followed by oral valdecoxib through day 10; intravenous placebo followed by oral valdecoxib; or placebo for 10 days. All patients had access to standard opioid medications. The primary end point was the frequency of predefined adverse events, including cardiovascular events, renal failure or dysfunction, gastroduodenal ulceration, and wound-healing complications. results As compared with the group given placebo alone, both the group given parecoxib and valdecoxib and the group given placebo and valdecoxib had a higher proportion of patients with at least one confirmed adverse event (7.4 percent in each of these two groups vs. 4.0 percent in the placebo group; risk ratio for each comparison, 1.9; 95 percent confidence interval, 1.1 to 3.2; P=0.02 for each comparison with the placebo group). In particular, cardiovascular events (including myocardial infarction, cardiac arrest, stroke, and pulmonary embolism) were more frequent among the patients given parecoxib and valdecoxib than among those given placebo (2.0 percent vs. 0.5 percent; risk ratio, 3.7; 95 percent confidence interval, 1.0 to 13.5; P=0.03). conclusions The use of parecoxib and valdecoxib after CABG was associated with an increased incidence of cardiovascular events, arousing serious concern about the use of these drugs in such circumstances.

Background The premise of coronary revascularization without cardiopulmonary bypass (off-pump coronary artery bypass graft [CABG]) proposes that patient morbidity and, potentially, mortality can be reduced without compromising the excellent results of conventional revascularization techniques (on-pump CABG). High-risk patients may benefit the most from off-pump CABG. The aim of this study was to compare early and mid-term clinical outcomes after off-pump CABG with on-pump CABG in a subset of high-risk patients. Methods Between January 1, 2000 and December 31, 2000, 513 high-risk patients with a Parsonnet's risk scores of 20 or higher underwent CABG; 38.6% (n = 198) underwent on-pump CABG, and 61.4% (n = 315) had off-pump CABG. Logistic regression was used to calculate the probability of being selected for on-pump CABG given a set of preoperative risk factors. Propensity scores or the probability of being selected for on-pump CABG were computed. Relative risks, heterogeneity among strata, and interactions between surgery type and the propensity score were assessed by a multivariate Cox proportional-hazards regression for the outcomes mortality and major adverse cardiac events (death, acute myocardial infarction, stroke, reoperative CABG, percutaneous coronary intervention). Results Operative mortality was lower after off-pump versus on-pump CABG between the two groups after controlling for preoperative risk factors using the propensity score (odds ratio=2.10; 95% confidence intervals=1.02 to 4.36, p = 0.04). In the Cox-regression analysis, off-pump CABG was associated with an improved survival rate compared with on-pump CABG ( p = 0.03). Off-pump CABG was associated with a comparable event-free survival ( p = 0.14) compared with on-pump CABG. Conclusions Off-pump CABG can be performed with a reasonably low morbidity and lower early and late mortality in high-risk patients. Off-pump CABG may be a better operative strategy in this subset of patients.

Objective: Off-pump coronary artery bypass (CABG) is a safe revascularization option with comparable or superior results to the conventional on-pump CABG. However, comparative analysis of the type of surgical approach on the mortality rate is largely unknown. This study sought to investigate whether CABG without cardiopulmonary bypass (off-pump CABG) is associated with lower operative mortality than the conventional on-cardiopulmonary bypass (on-pump) approach. Methods: From October 1998 to June 2001, off-pump CABG was performed on 2477 patients and on-pump CABG was performed on 3077 patients. The patients undergoing off-pump CABG were randomly matched to on-pump patients via propensity score. Seventy-four percent of the off-pump CABG patients were matched with on-pump patients via propensity scores. A logistic regression model was used to test the difference in the postoperative mortality rate between off-pump CABG and on-pump CABG, controlling the correlation between matched sets. A multiple logistic regression model predicting the risk of mortality adjusted by risk factors of mortality and operation type was computed. Results: Results from the general estimating equation showed that patients who had on-pump CABG were 1.6 (95% confidence intervals (CI) = 1.2-2.0, P < 0.01) times more likely to die during the first 30 days after surgery than patients who had off-pump CABG. Independent predictors of 30-day mortality identified from the multiple logistic model included on-pump CABG (versus off-pump CABG), advanced age, female gender, carotid artery disease, chronic renal failure, depressed ejection fraction, reoperative CABG, preoperative intraaortic balloon counterpulsation, and recent myocardial infarction. Conclusion: Excellent clinical results and a lower operative mortality rate can be achieved with the off-pump CABG technique compared with the conventional on-pump approach.

Background During cardiac surgery requiring cardiopulmonary bypass, pro-inflammatory complement pathways are activated by exposure of blood to bio-incompatible surfaces of the extracorporeal circuit and reperfusion of ischemic organs. Complement activation promotes the generation of additional inflammatory mediators thereby exacerbating tissue injury. We examined the safety and efficacy of a C5 complement inhibitor for attenuating inflammation-mediated cardiovascular dysfunction in cardiac surgical patients undergoing cardiopulmonary bypass. Methods Pexelizumab (Alexion Pharmaceuticals, Inc, Cheshire, CT), a recombinant, single-chain, anti-C5 monoclonal antibody, was evaluated in a randomized, double-blinded, placebo-controlled, multicenter trial that involved 914 patients undergoing coronary artery bypass grafting with or without valve surgery requiring cardiopulmonary bypass. Results Pexelizumab was administered intravenously as a bolus (2.0 mg/kg) or bolus plus infusion (2.0 mg/kg plus 0.05 mg/kg/h for 24 hours), and inhibited complement activation. There were no statistically significant differences between placebo-treated and pexelizumab-treated patients in the primary endpoint (composite of death, or new Q-wave, or non-Q-wave [myocardial-specific isoform of creatine kinase > 60 ng/mL] myocardial infarction, or left ventricular dysfunction, or new central nervous system deficit). However, post hoc analysis revealed a reduction in the composite of death or myocardial infarction (myocardial-specific isoform of creatine kinase ≥ 100 ng/mL) for the isolated coronary artery bypass grafting, bolus plus infusion subgroup on POD 4 ( p = 0.007) and on POD 30 ( p = 0.004). Conclusions Pexelizumab had no statistically significant effect on the primary endpoint. However, the reduction in death or myocardial infarction (myocardial-specific isoform of creatine kinase ≥ 100 ng/mL) as revealed in the post hoc analysis in the isolated coronary artery bypass grafting bolus plus infusion subpopulation, suggests that further investigation of anti-C5 therapy for ameliorating complement-mediated inflammation and myocardial injury is warranted.

OBJECTIVES We sought to investigate whether the chronologic distribution of the onset of stroke occurring after coronary artery bypass graft surgery (CABG) without cardiopulmonary bypass (off-pump CABG) is different from the conventional on-pump approach (CABG with cardiopulmonary bypass). BACKGROUND Off-pump CABG has been associated with a lower stroke rate, compared with conventional on-pump CABG. However, it is unknown whether the chronologic distribution of the onset of stroke is different between the two approaches. METHODS We evaluated the chronologic distribution of postoperative stroke in patients undergoing CABG from June 1996 to August 2001 (n = 10,573). Preoperative risk factors for stroke were identified using the Northern New England preoperative estimate of stroke risk. Multivariate logistic regression analysis was used to determine the independent predictors of early stroke and to delineate the association between the surgical approach and the chronologic distribution of the onset of stroke. RESULTS Stroke occurred in 217 patients (2%, n = 10,573). A total of 44 (20%) and 173 (80%) of these patients had stroke after off-pump CABG and on-pump CABG, respectively. The median time for the onset of stroke was two days (range 0 to 11 days) after on-pump CABG versus four days (range 0 to 14 days) after off-pump CABG (p < 0.01). On-pump CABG was associated with a higher risk of early stroke (odds ratio 5.3, 95% confidence interval 2.6 to 10.9; p < 0.01) compared with off-pump CABG. CONCLUSIONS Compared with off-pump CABG, on-pump CABG is associated with an earlier onset of postoperative stroke during the recovery phase, suggesting different mechanisms in the pathogenesis of stroke between the two surgical approaches.

We present a hybrid technique of left ventricular assist device exclusion after bridge to recovery in a pediatric patient, using percutaneous occlusion of the outflow graft and surgical excision of driveline. This technique has the advantage of avoiding chest reentry and cardiopulmonary bypass.

Objectives: To evaluate the effects of cariporide on all-cause mortality or myocardial infarction at 36 days in patients at risk,of myocardial necrosis after coronary artery bypass graft surgery. Methods: In the coronary artery bypass graft cohort of the GUARD During Ischemia Against Necrosis trial, patients greater than or equal to 18 years who required urgent coronary artery bypass graft, repeat coronary artery bypass graft, or had a history of unstable angina and 2 :2 risk factors (age >65 years, female gender, diabetes mellitus, ejection fraction

Long-term outcomes after coronary artery bypass graft surgery (CABG) plus transmyocardial revascularization (TMR) are largely unknown. We report the results of 30-day and 3-, 6-, and 12-month clinical follow-up after CABG plus TMR in a consecutive series of patients with refractory angina pectoris andor = 1 myocardial ischemic area not amenable to CABG. All patients who underwent CABG plus TMR (n = 169) (mean age 63 +/- 10 years, 70% men, 51% with previous CABG, 82% were deemed inoperable at other heart surgery centers due to small vessels or diffuse disease) between March 1996 and February 2000 were clinically followed and end points of interest (survival, stroke, acute myocardial infarction, and revascularization) and angina class were recorded at 30 days and 3, 6, and 12 months after CABG. At 1 year, actuarial survival and event-free survival were 85% and 81%, respectively. At the end of the first year after the procedure, 7 patients (4%) had angina class III/IV versus 152 patients (90%) at baseline (p0.001). Predictors of major adverse cardiac events were advanced age (odds ratio [OR] 3.4, 95% confidence intervals [CI] 1.2 to 9.4, p = 0.01), prolonged intensive care unit stay (OR 3.3, CI 1.1 to 9.7, p0.001), new-onset atrial fibrillation (OR 2.8, CI 1.1 to 7.0, p = 0.02), and in-hospital myocardial infarction (OR 1.5, CI 1.3 to 1.7, p0.001). Thus, procedural success at 30 days and overall event-free and actuarial survival in a high-risk population setting shows that CABG plus TMR is a safe revascularization option for patients with intractable angina pectoris.

OBJECTIVES We sought to determine if elevated cardiac serum biomarkers after coronary artery bypass graft surgery (CABG) are associated with increased medium-term mortality and to identify patients that may benefit from better postoperative myocardial protection. BACKGROUND The relationship between the magnitude of cardiac serum protein elevation and subsequent mortality after CABG is not well defined, partly because of the lack of large, prospectively studied patient cohorts in whom postoperative elevations of cardiac serum markers have been correlated to medium- and long-term mortality. METHODS The GUARD during Ischemia Against Necrosis (GUARDIAN) study enrolled 2,918 patients assigned to the entry category of CABG and considered as high risk for myocardial necrosis. Creatine kinase-myocardial band (CK-MB) isoenzyme measurements were obtained at baseline and at 8, 12, 16 and 24 h after CABG. RESULTS The unadjusted six-month mortality rates were 3.4%, 5.8%, 7.8% and 20.2% for patients with a postoperative peak CK-MB ratio (peak CK-MB value/upper limits of normal [ULN] for laboratory test) of CONCLUSIONS Progressive elevation of the CK-MB ratio in clinically high-risk patients is associated with significant elevations of medium-term mortality after CABG. Strategies to afford myocardial protection both during CABG and in the postoperative phase may serve to improve the clinical outcome.

Background . Minimally invasive direct coronary artery bypass, without cardiopulmonary bypass, through a left lateral thoracotomy approach (lateral MIDCAB), is a safe alternative to coronary artery bypass surgery using cardiopulmonary bypass (on-pump CABG) of the circumflex system via median sternotomy. However, it is unknown whether lateral MIDCAB may yield an improved long-term outcome over the conventional on-pump median sternotomy approach. Methods . We compared the perioperative outcomes of patients undergoing lateral MIDCAB (n = 34) versus conventional on-pump CABG of the circumflex system (n = 16) from June 1996 to July 1999. The two groups were similar with respect to baseline characteristics and risk stratification. Patients who required only one or two grafts for complete revascularization were included. Results . Lateral MIDCAB patients had a lower need than on-pump CABG patients for intraoperative (12% MIDCAB vs 43% on-pump CABG, p = 0.03) and postoperative transfusions (29% vs 69%, p = 0.01), had fewer neuropsychologic changes (0% vs 19%, p = 0.03), and had a lower rate of postoperative atrial fibrillation (12% vs 44%, p = 0.02). Lateral MIDCAB was also associated with a significantly lower postoperative length of stay (5 ± 2 vs 7 ± 3 days, p = 0.02). Actuarial survival at a mean period of follow-up of 19 ± 11 months was 97% for the lateral MIDCAB versus 88% for the on-pump CABG group ( p = 0.6). Event-free survival was 88% for lateral MIDCAB versus 81% for on-pump CABG ( p = 0.1). Conclusions . Lateral MIDCAB may safely be performed in patients with isolated coronary artery disease of the circumflex system with improved early morbidity and an abbreviated hospital stay compared with conventional median sternotomy on-pump CABG.

Postoperative atrial fibrillation (AF) is a frequent adverse event after coronary artery bypass grafting (CABG) and may negatively affect the early clinical outcome. We sought to investigate the risk factors, prevalence, and prognostic implications of postoperative AF in patients submitted to CABG without cardiopulmonary bypass (off-pump). The study population comprised 969 patients, 645 men (67%) and 324 women (33%) who had off-pump CABG at the Washington Hospital Center from January 1987 to May 1999. Preoperative AF patients were excluded (n = 15). Two hundred six patients (age 69 +/- 10 years, 137 men [66%]) developed AF, whereas 763 patients (age 61 +/- 12 years, 508 men [67%]) did not. Predictors of AF included age >75 years (odds ratio [OR] 3.0, 95% confidence interval [CI] 1.9 to 4.5; p

Background . Octogenarians have higher morbidity and mortality rates (9% to 16%) after coronary artery bypass grafting with cardiopulmonary bypass, compared with younger patients. Methods . We compared the perioperative outcome and hospital stay after coronary artery bypass grafting without cardiopulmonary bypass (off-pump) from January 1987 to May 1999, among patients older than 80 years (n = 71), patients between 70 and 79 years (n = 228), and patients whose age ranged from 60 to 69 years (n = 296). In comparison with younger patients, more octogenarians were female (51% versus 39% in patients aged 70 to 79 years and 35% in those aged 60 to 69 years, p = 0.04), they had previous myocardial infarction more frequently (48% versus 47% versus 34%, respectively, p = 0.008), and were operated on urgently (69% versus 56% versus 52%, respectively, p = 0.04). Results . Postoperative complications that were significantly higher in octogenarians compared with younger groups included pneumonia (6% in octogenarians versus 2% in patients aged 70 to 79 years and 0% in patients aged 60 to 69 years, p = 0.001) and atrial fibrillation (47% versus 32% versus 21%, respectively, p p p = 0.006). Conclusions . When appropriately applied in patients older than 80 years, off-pump coronary artery bypass grafting can be done with acceptable postoperative morbidity, mortality, and hospital stay.

Acknowledgment: The figures in this article were provided by ABIOMED Cardiovascular, Inc. Introduction Centralized tertiary care has increased the need for patient transfer from local hospitals to regional centers of excellence. Interhospital transport of critically ill patients long has been the mission of many helicopter programs, including MedSTAR Transport of Washington Hospital Center. The movement of patients with ventricular assist devices (VADs) by ambulance, fixed-wing aircraft, and helicopter is becoming more widespread.‘,2 We pre sent the first case in the literature of a rotor-wing transport of a patient with an open chest and a biventricular assist de vice, the ABIOMED BVS 5000 biventricular support system (ABIOMED Cardiovascular, Inc., Danvers, Mass.). Through preflight planning, intlight adap tation, and postflight debriefing, we have developed innovative strategies to facilitate the transport of highly complex cardiac patients. Key considerations include the equipment, helicopter, and crew composition and training. The purpose of this case report is to share our experience and provide a template for future complex transports.

Background Photopheresis is an immunoregulatory technique in which lymphocytes are reinfused after exposure to a photoactive compound (methoxsalen) and ultraviolet A light. We performed a preliminary study to assess the safety and efficacy of photopheresis in the prevention of acute rejection of cardiac allografts. Methods A total of 60 consecutive eligible recipients of primary cardiac transplants were randomly assigned to standard triple-drug immunosuppressive therapy (cyclosporine, azathioprine, and prednisone) alone or in conjunction with photopheresis. The photopheresis group received a total of 24 photopheresis treatments, each pair of treatments given on two consecutive days, during the first six months after transplantation. The regimen for maintenance immunosuppression, the definition and treatment of rejection episodes, the use of prophylactic antibiotics, and the schedule for cardiac biopsies were standardized among all 12 study centers. All the cardiac-biopsy samples were graded in a blinded m...

A 45-year-old man had life-threatening recurrent idiopathic ventricular fibrillation and persistent cardiogenic shock develop. The episodes of ventricular fibrillation were refractory to aggressive medical management; therefore an Abiomed AB5000 bi-ventricular support system was implanted for arrhythmia control. The device was able to maintain hemodynamic stability during the following 2 weeks. The patient was discharged from the hospital with fully recovered cardiac function.

s S195 Conclusion: Significant residual MR post LVAD implantation assessed quantitatively is associated with increased LA and LV dimensions, and worse RV size and function. Further studies are warranted to determine whether residual significant MR affects long term outcomes in LVAD patients.