Multicenter, Prospective Trial of Nonendoscopic Biomarker-Driven Detection of Barrett's Esophagus and Esophageal Adenocarcinoma.

INTRODUCTION: Preliminary data suggest that an encapsulated balloon (EsoCheck), coupled with a 2 methylated DNA biomarker panel (EsoGuard), detects Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC) with high accuracy. The initial assay requires sample freezing upon collection. The purpose of this study was to assess a next-generation EsoCheck sampling device and EsoGuard assay in a much-enlarged multicenter study clinically enhanced by using a Clinical Laboratory Improvement Amendments of 1988-compliant assay and samples maintained at room temperature. METHODS: Cases with nondysplastic BE (NDBE), dysplastic BE (indefinite for dysplasia, low-grade dysplasia, high-grade dysplasia), EAC, junctional adenocarcinoma, plus endoscopy controls without esophageal intestinal metaplasia, were prospectively enrolled. Medical assistants at 6 institutions delivered the encapsulated balloon per orally with inflation in the stomach. The inflated balloon sampled the distal 5 cm of the esophagus and then was deflated and retracted into the capsule, preventing sample contamination. EsoGuard bisulfite sequencing assayed levels of methylated vimentin and methylated cyclin A1. RESULTS: A total of 243 evaluable patients-88 cases (median age 68 years, 78% men, 92% White) and 155 controls (median age 57 years, 41% men, 88% White)-underwent adequate EsoCheck sampling. The mean procedural time was approximately 3 minutes. Cases included 31 with NDBE, 16 with indefinite for dysplasia/low-grade dysplasia, 23 with high-grade dysplasia, and 18 with EAC/junctional adenocarcinoma. Thirty-seven NDBE and dysplastic BE cases (53%) were short-segment BE (<3 cm). Overall sensitivity was 85% (95% confidence interval 0.78-0.93) and specificity was 85% (95% confidence interval 0.79-0.90). Sensitivity for NDBE was 84%. EsoCheck/EsoGuard detected 100% of cancers (n = 18). DISCUSSION: EsoCheck/EsoGuard demonstrated high sensitivity and specificity in detecting BE and BE-related neoplasia.

NON-ENDOSCOPIC ESOPHAGEAL SAMPLING DEVICE AND BIOMARKER PANEL FOR DETECTION OF BARRETT'S ESOPHAGUS (BE) AND ESOPHAGEAL ADENOCARCINOMA (EAC).

BACKGROUND: We previously reported an encapsulated balloon (EsoCheck TM , EC), which selectively samples the distal esophagus, that coupled with a two methylated DNA biomarker panel (EsoGuard TM , EG), detected Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC), with a sensitivity and specificity of 90.3% and 91.7%, respectively. This previous study utilized frozen EC samples. AIM: To assess a next generation EC sampling device and EG assay that utilizes a room temperature sample preservative to enable office-based testing. METHODS: Cases with nondysplastic (ND) and dysplastic (indefinite=IND, low grade dysplasia = LGD, high grade dysplasia = HGD) BE, EAC, junctional adenocarcinoma (JAC) and controls with no intestinal metaplasia (IM) were included. Nurses or physician assistants at six institutions, who were trained in EC administration, delivered the encapsulated balloon per orally and inflated it in the stomach. The inflated balloon was pulled back to sample 5 cm of the distal esophagus, then deflated and retracted into the EC capsule to prevent sample contamination from proximal esophagus. Nextgen EG sequencing assays performed on bisulfite-treated DNA extracted from EC samples determined levels of methylated Vimentin (mVIM) and methylated Cyclin A1 (mCCNA1) in a CLIA-certified laboratory, blinded to patients' phenotypes. RESULTS: A total of 243 evaluable patients - 88 cases (median age 68 years, 78% men, 92% white) and 155 controls (median age 57 years, 41% men, 88% white) - underwent adequate EC sampling. Mean time for EC sampling was just over 3 minutes. The cases included 31 NDBE, 16 IND/LGD, 23 HGD, and 18 EAC/JAC. Thirty-seven (53%) of the non-dysplastic and dysplastic BE cases were short-segment BE (SSBE; < 3 cm). Overall sensitivity for detecting all cases was 85% (95% CI= 0.78-0.93) and specificity was 85% (95% CI=0.79-0.90). Sensitivity for NDBE was 84% (n=37). The EC/EG test detected 100% of cancers. CONCLUSION: The next-generation EC/EG technology has been both successfully updated to incorporate a room temperature sample collection preservative and successfully implemented in a CLIA certified laboratory. When performed by trained personnel, EC/EG detects non-dysplastic BE, dysplastic BE, and cancer with high sensitivity and specificity, replicating the operating characteristics of the initial pilot study of this technology. Future applications utilizing EC/EG to screen broader populations at risk for developing cancer are proposed. SIGNIFICANCE: This multi-center study demonstrates the successful performance of a commercially available clinically implementable non-endoscopic screening test for BE in the U.S., as recommended in the most recent ACG Guideline and AGA Clinical Update. It transitions and validates a prior academic laboratory-based study of frozen research samples over to a CLIA laboratory, one that also integrates a clinically practical room temperature method for sample acquisition and storage, enabling office-based screening.

Outcomes After Surgical Pulmonary Embolectomy for Acute Pulmonary Embolus: A Multi-Institutional Study.

BACKGROUND: Surgical pulmonary embolectomy (SPE) has been sparingly used for the successful treatment of massive and submassive pulmonary emboli. To date, all data regarding SPE have been limited to single-center experiences. The purpose of this study was to document short-term outcomes after SPE for acute pulmonary emboli (PE) at four high-volume institutions. METHODS: A retrospective review of multiple local Society of Thoracic Surgeons databases of adults undergoing SPE from 1998 to 2014 for acute PE was performed (n = 214). Demographic, operative, and outcomes data were collected and analyzed. Patients were summarily categorized as having either massive or submassive PEs based on the presence or absence of preoperative vasopressors. RESULTS: A total of 214 patients with acute PE were treated by SPE. The mean age was 56.0 ± 14.5 years, and 92 (43.6%) patients were female. Of those, 176 (82.2%) PEs were submassive and 38 (17.8%) were massive. Fifteen (7.0%) patients underwent concomitant cardiac procedures, with 10 (4.7%) having simultaneous valvular interventions and 5 (2.4%) undergoing concomitant bypass grafting. Cardiopulmonary bypass (CPB) was used for all cases. Cardioplegic arrest was used for 80 (37.4%) patients. The median CPB and aortic cross clamp times were 71.5 (interquartile range [IQR], 47.0-109.5) and 46.0 (IQR, 26.0-74.5), respectively. Notably, only 25 (11.7%) patients died in the hospital. Mortality was highest among the 28 patients who experienced preoperative cardiac arrest (9, 32.1%) CONCLUSIONS: These data represent the first multicenter experience with SPE for acute pulmonary emboli. Surgical pulmonary embolectomy for acute massive and submassive PE is safe and can be performed with acceptable in-hospital outcomes; the procedure should be included in the multimodality treatment of life-threatening pulmonary emboli.

Acute pulmonary embolectomy: a contemporary approach.

BACKGROUND: Acute pulmonary embolism confers a high mortality rate despite advances in diagnosis and therapy. Thrombolysis is often effective but has a high frequency of major bleeding complications, especially intracranial hemorrhage. Therefore, we liberalized our criteria for acute pulmonary embolectomy and considered operating on patients with anatomically extensive pulmonary embolism and concomitant moderate to severe right ventricular dysfunction despite preserved systemic arterial pressure. METHODS AND RESULTS: We report 29 (17 men and 12 women) consecutive patients who underwent embolectomy from October 1999 through October 2001. Twenty-six patients (89%) survived surgery and were alive more than 1 month postoperatively. Median follow-up is 10 months. CONCLUSION: The high survival rate of 89% can be attributed to improved surgical technique, rapid diagnosis and triage, and careful patient selection. We hope that other tertiary centers will evaluate pulmonary embolism patients with an algorithm that includes surgical embolectomy as one of several therapeutic options. Our contemporary approach to pulmonary embolectomy no longer confines this operation to a treatment of last resort reserved for clinically desperate circumstances.

Hypothermic circulatory arrest for the surgical treatment of complicated adult coarctation of the aorta.

OBJECTIVES: This study was designed to evaluate the surgical treatment of recurrent coarctation by a new technique. BACKGROUND: Recurrent coarctation either from aneurysm or recurrent constriction is a difficult problem in the adult because of the possible interruption of important collateral circulation. METHODS: We reviewed four patients who underwent recurrent coarctation surgery with the use of deep hypothermic circulatory arrest (HCA). RESULTS: All four patients survived. Deep HCA facilitated precise surgical resection and there was no postoperative paraplegia, stroke, or myocardial infarction. CONCLUSIONS: Deep HCA and resection and grafting of the coarctation is indicated for complicated adult coarctations, particularly when the collateral circulation is in doubt.

Modern surgical treatment of massive pulmonary embolism: results in 47 consecutive patients after rapid diagnosis and aggressive surgical approach.

OBJECTIVES: This study retrospectively reviews an aggressive multidisciplinary approach to the treatment of massive pulmonary embolism, centering on rapid diagnosis with contrast-enhanced computed tomography of the chest to define the location and degree of clot burden and transthoracic echocardiography to document right ventricular strain followed by immediate surgical intervention when appropriate. METHODS: Between October 1999 through February 2004, 47 patients (30 men and 17 women; median age, 58 years; age range, 24-86 years) underwent emergency surgical embolectomy for massive central pulmonary embolism. The indications for surgical intervention were (1) contraindications to thrombolysis (21/47 [45%]), (2) failed medical treatment (5/47 [10%]), and (3) right ventricular dysfunction (15/47 [32%]). Preoperatively, 12 (26%) of 47 patients were in cardiogenic shock, and 6 (11%) of 47 were in cardiac arrest. RESULTS: There were 3 (6%) operative deaths, 2 with preoperative cardiac arrest; 2 of these 3 patients required a right ventricular assist device. In 38 (81%) patients a caval filter was placed intraoperatively. Median length of stay was 11 days (range, 3-75 days). Median follow-up was 27 months (range, 2-50 months); follow-up was 100% complete in surviving patients. There were 6 (12%) late deaths, 5 of which were from metastatic cancer. Actuarial survival at 1 and 3 years' follow-up was 86% and 83%, respectively. CONCLUSION: An aggressive approach to large pulmonary embolus, including rapid diagnosis and prompt surgical intervention, has improved results with surgical embolectomy. We now perform surgical pulmonary embolectomy not only in patients with large central clot burden and hemodynamic compromise but also in hemodynamically stable patients with right ventricular dysfunction documented by means of echocardiography.

Liberal use of delayed sternal closure for postcardiotomy hemodynamic instability.

BACKGROUND: The purpose of this retrospective study was to evaluate the current incidence, survival, and predictors of mortality for open chest management at our center. METHODS: Our database was analyzed to identify adult postcardiotomy patients who left the operating room without primary sternal closure. Medical records were reviewed to determine mortality, postoperative complications, and pertinent hemodynamic data. RESULTS: From November 1997 to June 2000, 5,177 adults underwent cardiac procedures at our center. The incidence of open chest management was 1.7% (87 of 5,177), including 0.7% (16 of 2,254) for isolated coronary artery bypass grafting, 1.6% (15 of 912) for isolated valve, and 5.6% (47 of 839) for combined valve/coronary bypass. Hospital survival was 76% (66 of 87). Major complications included deep sternal infection (n = 4), stroke (n = 8), and dialysis (n = 13). Predictors of mortality by univariate analysis included ventricular assist device insertion (p = 0.003), new onset hemodialysis (p < 0.0005), reoperation for bleeding (p = 0.002), sternal infection (p = 0.042), mean length of delay before sternal closure (survivors = 3.2 days, nonsurvivors = 6.2 days; p = 0.031), higher mean dose of epinephrine at the time of chest closure (2.5 microg versus 0.9 microg, p = 0.011), and longer duration of high dose inotropic therapy (110 hours versus 43 hours, p = 0.002). Multivariate analysis showed ventricular assistance and reoperation for bleeding as independent predictors of in-hospital death with odds ratios of 3.8 and 3.4, respectively. CONCLUSIONS: Liberal use of open chest management is useful in patients with postcardiotomy shock, and can be carried out with a relatively low incidence of sternal complications. Patients who require ventricular assistance or exploration for ongoing mediastinal bleeding continue to have a high mortality rate.

Open inferior vena caval anastomosis during bicaval heart transplantation.

Performing a precise inferior vena caval (IVC) anastomosis during bicaval orthotopic heart transplantation can sometimes be challenging because of crowding of the operative field by the venous cannula and tourniquet. We performed bicaval orthotopic heart transplantation in 10 patients using an open IVC anastomotic technique with vacuum-assisted venous drainage. A long venous cannula was passed into the IVC through the femoral vein. The IVC anastomosis was performed after removing the IVC tourniquet under vacuum-assisted venous drainage. A precise edge-to-edge IVC anastomosis was successfully performed in all patients. This technique may result in greater anastomotic precision and improved outcomes.

Aortic valve surgery after previous coronary artery bypass grafting with functioning internal mammary artery grafts.

BACKGROUND: Aortic valve surgery after coronary artery bypass grafting (CABG) in the setting of patent pedicled internal mammary artery (IMA) grafts poses a high risk because of the underlying ischemic and valve disease. Unlike mitral valve surgery or CABG, in which aortic clamping (AoX) may be optional, aortic valve surgery uniformly requires AoX unless circulatory arrest is used. Management of the IMA graft in these circumstances has traditionally involved dissection and clamping to prevent regional myocardial warming and cardioplegia "washout" during AoX. An alternative strategy involves avoiding dissection of the IMA, leaving the IMA graft open and establishing moderate-to-deep hypothermia during AoX and cardioplegic arrest. To date, no study has been published documenting the safety and efficacy of the latter practice. METHODS: A total of 94 patients who had patent IMA graft and underwent aortic valve surgery under AoX and cardioplegia between April 1992 and March 2001 were analyzed. The IMA was avoided and left open during AoX, and the patients were cooled systemically (median 20 degrees C). Patients ranged in age from 55 to 90 years (median 73.5 years). Ejection fraction was 15% to 83% (median 50%). Of the patients, 18 (19%) underwent minimally invasive upper hemi-resternotomy. Analysis for predictors of outcome was performed. RESULTS: The operative mortality, perioperative myocardial infarction (MI), and stroke rates were 6.4%, 7%, and 11%, respectively. No significant independent predictors of operative mortality or MI could be identified in the multivariate analysis, although a trend was shown for operative mortality with urgent procedures and patients requiring concomitant surgery of the ascending or arch aorta or aortic root. Advanced age and prolonged cardiopulmonary bypass predicted stroke in the multivariate analysis. There were five (5%) IMA injuries, all occurring during reentry or mediastinal dissection, but none in the subgroup of patients who underwent minimally invasive procedures. All patients survived. CONCLUSIONS: Patients undergoing aortic valve surgery after CABG in the presence of patent IMA represent a potentially high-risk group. Because AoX is almost uniformly required, a decision regarding the management of the IMA pedicle is needed. We have found that leaving the IMA undissected and unclamped is a reasonable strategy, provided that systemic cooling for myocardial protection is established to prevent regional warming and to compensate for cardioplegia washout effect during AoX.

Future technology for off-pump coronary artery bypass (OPCAB).

Over the past 5 years, many coronary artery surgeons have embraced technology and advanced the field of beating heart surgery to the point where off-pump coronary artery bypass (OPCAB) is becoming a mature procedure. Enabling technologies are now available for all stages of the procedure, including cardiac positioning, coronary artery stabilization, coronary artery visualization, and performance of the proximal and distal anastomoses. Despite these successes, only a minority of cardiac surgeons performs this procedure routinely. Proponents of OPCAB and the medical device industry will need to continue to develop new technologies to make OPCAB less technically challenging and more widely accepted. Progress towards routine single-vessel off-pump totally endoscopic coronary artery bypass has been slow. Translating the benefits of multivessel OPCAB to an endoscopic setting remains a formidable challenge that will require further technologic breakthroughs.

Surgical treatment of the ischemic mitral valve.

The best management for moderate mitral regurgitation (MR) at the time of coronary revascularization remains controversial. During the era preceding standardization of mitral annuloplasty, coronary artery bypass grafting (CABG) alone was the most common strategy for ischemic MR. This approach avoided mitral valve replacement, and there was an expectation that myocardial revascularization would improve papillary muscle function and valve performance. Long-term follow up revealed, however, a relationship between residual MR and mortality. Recent studies have further refined management of ischemic MR. It is now understood that Carpentier type IIIb dysfunction is the basis for ischemic MR, and that a reduction remodeling annuloplasty can improve leaflet coaptation in this setting. Mortality after combined CABG and mitral annuloplasty has decreased in our institution from 14% to 4% over the past decade. Furthermore, a strategy of CABG alone will leave a significant number of patients (approximately 40%) with moderate to severe MR. Our current approach is to explore all valves at the time of CABG with documented grade 3+ MR on preoperative transthoracic echocardiography. Intraoperative transesophageal echocardiography (TEE) underestimates moderate MR. In patients with a lesser degree of MR, intraoperative provocative testing guides our valve strategy. Severe left ventricular dysfunction and a history of congestive heart failure will also influence the decision regarding valve exploration at the time of CABG. A prospective randomized trial between CABG and CABG + mitral annuloplasty is necessary to further define the best management strategy for patients with moderate ischemic MR.

Management of mild to moderate aortic stenosis at the time of coronary artery bypass grafting.

An increasing number of patients are referred for coronary artery bypass surgery (CABG) with the presence of mild to moderate aortic stenosis (AS). It is well accepted that patients with severe AS and coronary artery disease (CAD) should undergo combined aortic valve replacement (AVR) and CABG, which carries an operative mortality of approximately 5-7%. For patients with CAD and mild AS, controversy persists regarding concomitant AVR during CABG. It has been shown that AS progresses at a rate of 5-10 mmHg per year, and the valve area decreases by about 0.1 cm2 per year. The progression of AS is more rapid in elderly patients, in the presence of CAD, and in patients with a calcific degenerative etiology. In contrast, patients with congenital bicuspid valves or rheumatic pathology demonstrate slower progression of disease. Despite these observations, it is difficult to predict reliably the progression of disease for an individual. Thus, an attempt should be made to identify patients who are likely to progress rapidly from mild to severe AS and who would therefore benefit from AVR/CABG. Our approach regarding the decision to perform an AVR/CABG is based on aortic valve gradient and area. If the gradient is >25 mmHg, AVR should be considered. If the gradient is <10 mmHg, then only CABG is performed. Severities of leaflet calcification and leaflet mobility are factors that should be taken into account when deciding to perform concomitant AVR/CABG for intermediate gradient (10-25 mmHg). Additional important variables include the etiology of aortic valve disease, the rate of progression of AS, the patient's life expectancy, and general condition. For patients with mild AS who are undergoing CABG, a tailored approach involving intraoperative transesophageal echocardiography and valve inspection is the most appropriate surgical option.

Current results of combined coronary artery bypass grafting and mitral annuloplasty in patients with moderate ischemic mitral regurgitation.

BACKGROUND AND AIM OF THE STUDY: Combined coronary artery bypass grafting (CABG) and mitral annuloplasty for ischemic mitral regurgitation (MR) is historically associated with high operative mortality, and remains controversial in the setting of moderate ischemic MR. Herein, operative mortality rates in patients undergoing combined CABG and mitral annuloplasty for moderate ischemic MR were examined. METHODS: Between January 1992 and August 1999, 108 patients with moderate (grade 3+) ischemic MR and coronary artery disease underwent combined CABG and mitral annuloplasty. Univariable analysis was used to identify perioperative risk factors associated with operative mortality in patients undergoing surgery during two different time periods (1992-95 versus 1996-99). Bivariable logistic regression was used to evaluate the possible effect of era on operative mortality, while controlling for potential confounders. RESULTS: The overall operative mortality was 6.4%. During 1992-95 the operative mortality was 14% (4/28), but fell to 3.7% (3/80) during 1996-99 (p = 0.07). Patients from the earlier period were more likely to have unstable angina, worse NYHA functional class, and preoperative atrial fibrillation. Patients from the latter period were more likely to have peripheral vascular disease and chronic obstructive pulmonary disease. The unadjusted odds ratio (OR) for operative mortality associated with the earlier era was 4.3 (95% CI 9-20.8; p = 0.07). In the bivariable logistic regression models, where patient characteristics that potentially were responsible for the difference in mortality were added, the OR for operative mortality associated with the 1992-95 era ranged from 3.4 to 6.7. None of the patient characteristics appreciably reduced this risk. CONCLUSION: Recent decreased operative mortality in combined CABG and mitral annuloplasty for moderate ischemic MR suggests that a more liberal application of this approach may be warranted.

Right ventricular volume measurement using the conductance catheter method: validation in excised porcine hearts.

The conductance catheter method for measuring right ventricular (RV) volume changes was assessed in seven excised porcine hearts. A 5-FG conductance catheter was placed within a latex balloon and positioned in the RV cavity of seven freshly excised porcine hearts. Conductance was recorded while saline was withdrawn from the intraventricular balloon in 2 ml decrements. Linear regression analysis of measured conductance versus reference volumes was computed. The effect of left ventricular (LV) filling and catheter length on conductance derived RV volume was also determined. Conductance derived volumes were highly correlated with reference volumes [R2 0.976, standard deviation (SD) 0.035]. The mean gradient of regression was 0.97 (SD 0.10), and it was not significantly affected by LV volume alterations. However, when we analyzed LV filling, a small but significant increase in the y-intercept was observed (LV empty 3.11 ml, SD 1.71; LV full 4.58, SD 2.39; p = 0.008). Introduction of the catheter through either the tricuspid or pulmonary orifices were both effective in ventricular volume measurement. The effect of mismatch between the catheter length and the RV long axis dimension was evaluated by changing the position of the active sensing electrodes along the catheter body. Conductance measurements, obtained from catheters shorter than the long axis of the RV, still maintained a highly linear correlation with real volume, but regression gradients were significantly reduced (long 0.975, SD 0.087; medium 0.787, SD 0.094; small 0.589, SD 0.091; p < 0.001). These results show that a conductance catheter of appropriate length can accurately measure RV volume, despite the complex shape and geometric changes associated with ventricular filling.

Infected aortic pseudoaneurysm at the site of a proximal mechanical anastomosic connector following off-pump coronary artery bypass grafting: case report.

We describe a patient who underwent off-pump coronary artery bypass graft surgery performed with an aortic connector. The patient developed a malignant deep sternal wound infection that subsequently led to an aortic pseudoaneurysm at the site of proximal anastomosis.

Intraluminal coronary shunting preserves regional myocardial perfusion and function.

BACKGROUND: Coronary artery hemostasis during offpump coronary artery bypass (OPCAB) may be achieved with extraluminal coronary occlusion or intraluminal coronary shunting. We sought to determine with a normal porcine beating-heart model whether coronary shunting preserves regional myocardial perfusion and function compared with coronary occlusion. METHODS: Six pigs (50-60 kg) underwent sternotomy and instrumentation. Two pairs of ultrasonic crystals were placed in the distribution of t h e left anterior descending (LAD) and left circumflex (LCx) arteries for measurement of fractional change in area (FCA), an index of regional contractility. Regional myocardial blood flow (RMBF) was determined with radiolabeled microspheres. Data were recorded for each animal at baseline and after LAD arteriotomy and vascular control with (1) a 1.5-mm intraluminal shunt, (2) proximal occlusion, and (3) proximal and distal occlusion. RESULTS: One pig experienced ventricular fibrillation during LAD manipulation and was excluded from the study. Data were summarized for the remaining 5 animals. Coronary shunting maintained RMBF and function (FCA) compared with baseline. Proximal occlusion led to 50% (P =.05) and 47% (P =.04) decreases in RMBF and FCA, respectively, in the LAD region. Proximal and distal occlusion led to 55% (P =.03) and 51% (P = 02) decreases in RMBF and FCA, respectively, in the LAD region. There were no significant changes in RMBF or FCA in the LCx (control) region. CONCLUSION: Intraluminal coronary shunting is capable of preserving distal myocardial perfusion and function in a normal porcine heart. Coronary occlusion, in contrast, significantly reduces regional perfusion and function. More frequent use of intracoronary shunting may facilitate OPCAB by minimizing ischemia and hemodynamic compromise.

Sternal closure with rigid plate fixation versus wire closure: a randomized controlled multicenter trial.

BACKGROUND: Rigid bone fixation is the standard of care for all bone reconstructions except that after sternotomy. Sternal reconstruction after median sternotomy using rigid fixation with plates may improve bone healing and reduce pain when compared with wire cerclage. METHODS: One-hundred forty patients at six centers who were determined preoperatively to be at high risk for sternal wound complications were randomly assigned to sternal closure with rigid plate fixation (n=70) or wire cerclage (n=70). Sternal healing was evaluated at 3 or 6 months by a core laboratory using computed tomography. Pain and function were evaluated at postoperative day 3 through discharge, 3 weeks, 6 weeks, 3 months, and 6 months. RESULTS: Sternal healing was superior in rigid plate fixation patients at both 3 and 6 months. Mean computed tomography scores in the rigid plate fixation and wire cerclage groups at 3 months were 1.7±1.1 and 0.9±0.8 (p=0.003). At 6 months, the scores were 3.2±1.6 and 2.2±1.1, respectively (p=0.01). At 6 months, 70% of rigid plate fixation patients had achieved sternal union, compared with 24% of conventional wire cerclage patients (p=0.003). Pain scores and narcotic usage were lower in rigid plate fixation patients. Significant differences in pain scores were observed at 3 weeks for total pain (p=0.020) and pain with coughing (p=0.0084) or sneezing (p=0.030). Complication rates were similar in both groups. CONCLUSIONS: Sternal reconstruction using rigid fixation with plates improved bone healing and reduced early postoperative pain compared with wire cerclage.

Cardiac positioning using an apical suction device maintains beating heart hemodynamics.

BACKGROUND: Cardiac positioning during off-pump coronary artery bypass (OPCAB) using deep pericardial sutures (DPS) typically results in some degree of hemodynamic compromise. We sought to determine whether cardiac positioning using an apical suction device was hemodynamically superior to DPS. METHODS: Five healthy pigs underwent sternotomy and instrumentation to measure right atrial (RA) pressure, left ventricular (LV) pressure and volume, and aortic pressure and flow. These variables were recorded at baseline, with simple attachment of the apical suction device (Xpose Access Device, Guidant, Inc.), and during exposure of the posterior descending artery (PDA) and obtuse marginal (OM) branches of the left circumflex artery using DPS and the apical suction device. RESULTS: Application of the apical suction device to the beating heart in neutral anatomic position did not result in any statistically significant change in hemodynamics compared to baseline except for a small decrease in RA pressure. DPS positioning resulted in statistically significant compromise in nearly all measured hemodynamic parameters, including cardiac output (-21% PDA, -30% OM), mean arterial pressure (-18% PDA, -26% OM), and stroke work (-31% PDA, -38% OM). In addition, LV end-diastolic pressure decreased (-59% PDA, -51% OM) while RA pressure increased (+17% PDA, +16% OM). Similar target exposure using the apical suction device resulted in near-baseline hemodynamics. The only statistically significant changes were a modest decrease in cardiac output (-18% OM) and RA pressure (-11% PDA). CONCLUSION: DPS positioning significantly compromises hemodynamics due to reduced LV filling. The apical suction device provides good exposure with less hemodynamic compromise.