Real-World Clinical Utility of a Methylated DNA Biomarker Assay on Samples Collected with a Swallowable Capsule-Balloon for Detection of Barrett's Esophagus (BE).

Barrett's Esophagus (BE) is the only known precursor for esophageal adenocarcinoma (EAC). Patients with multiple risk factors for BE/EAC are recommended for screening; however, few eligible patients undergo evaluation by endoscopy. EsoGuard (EG) is a commercially available biomarker assay used to analyze esophageal cells collected non-endoscopically with EsoCheck (EC) for the qualitative detection of BE/EAC.

Use of a Two-Gene Methylated DNA Biomarker Assay and Nonendoscopic Balloon for Detection of Barrett Esophagus Among High-Risk Individuals in a Screening Population.

Introduction: Barrett esophagus (BE) is the precursor to esophageal adenocarcinoma (EAC). We aimed to assess performance, safety, and tolerability of the EsoGuard (EG) assay on samples collected nonendoscopically with the EsoCheck (EC) device (EG/EC) for BE detection in the intended-use population meeting American College of Gastroenterology guideline criteria (chronic gastroesophageal reflux disease and 3+ additional risk factors).

Methods: We performed a prospective, multicenter study (NCT04293458) to assess EG performance (primary endpoint) on cells collected with EC, for detection of BE and EAC using esophagogastroduodenoscopy (EGD) and biopsies as the comparator.

Analytical Validation of a DNA Methylation Biomarker Test for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma from Samples Collected Using EsoCheck, a Non-Endoscopic Esophageal Cell Collection Device.

Barrett's esophagus (BE) is a known precursor to esophageal adenocarcinoma (EAC). Guidelines recommend BE screening in populations with multiple risk factors, for which non-endoscopic esophageal cell collection with biomarker testing is considered as an acceptable alternative to esophagogastroduodenoscopy (EGD). The aim of this study was to evaluate analytical performance characteristics of EsoGuard (EG), a DNA methylation biomarker assay, as a laboratory-developed test (LDT) in esophageal samples collected with the swallowable EsoCheck (EC) device.

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.

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 , EC), which selectively samples the distal esophagus, that coupled with a two methylated DNA biomarker panel (EsoGuard , EG), detected Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC), with a sensitivity and specificity of 90.3% and 91.7%, respectively.

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.

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).

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%]).

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.