Three-year results of a multicenter prospective study of transoral incisionless fundoplication.

BACKGROUND: To date, there are no long-term data on the use of transoral incisionless fundoplication (TIF) for the treatment of chronic gastroesophageal reflux disease (GERD). We sought to prospectively evaluate the long-term safety and durability of TIF in a multi-center setting. METHODS: A longitudinal per protocol (PP) and a modified intention-to-treat (mITT) analysis at 1 and 3 years consisted of symptom evaluation using the GERD health-related quality of life (GERD-HRQL) questionnaire, medication use, upper gastrointestinal endoscopy, and pH-metry. RESULTS: Of 79 patients previously reported at 1 year, 12 were lost to follow-up, and 1 died from an unrelated cause. The remaining 66 patients were followed up and analyzed (mITT). Of 66 patients, 12 underwent revisional procedures, leaving 54 patients for PP analysis at a median of 3.1 years (range = 2.9-3.6). No adverse events related to TIF were reported at 2- or 3-year follow-up. On PP analysis, median GERD-HRQL score off proton pump inhibitors (PPIs) improved significantly to 4 (range 0-32) from both off (25 [13-38], P < .0001) and on (9 [0-22], P < .0001) PPIs. Discontinuation of daily PPIs was sustained in 61% (mITT) and 74% (PP) of patients. Of 11 patients with pH data at 3 years (PP), 9 (82%) remained normal. Based on mITT analysis, 9/23 (39%) remained normal at 3 years. CONCLUSIONS: The clinical outcomes at 3 years following TIF, patient satisfaction, healing of erosive esophagitis, and cessation of PPI medication support long-term safety and durability of the TIF procedure for those with initial treatment success. Although complete normalization of pH studies occurred in a minority of patients, successful cases showed long-term durability.

Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study.

BACKGROUND: A novel transoral incisionless fundoplication (TIF) procedure using the EsophyX system with SerosaFuse fasteners was designed to reconstruct a full-thickness valve at the gastroesophageal junction through tailored delivery of multiple fasteners during a single-device insertion. The safety and efficacy of TIF for treating gastroesophageal reflux disease (GERD) were evaluated in a prospective multicenter trial. METHODS: Patients (n = 86) with chronic GERD treated with proton pump inhibitors (PPIs) were enrolled. Exclusion criteria included an irreducible hiatal hernia > 2 cm. RESULTS: The TIF procedure (n = 84) reduced all hiatal hernias (n = 49) and constructed valves measuring 4 cm (2-6 cm) and 230 degrees (160 degrees -300 degrees ). Serious adverse events consisted of two esophageal perforations upon device insertion and one case of postoperative intraluminal bleeding. Other adverse events were mild and transient. At 12 months, aggregate (n = 79) and stratified Hill grade I tight (n = 21) results showed 73% and 86% of patients with >or=50% improvement in GERD health-related quality of life (HRQL) scores, 85% discontinuation of daily PPI use, and 81% complete cessation of PPIs; 37% and 48% normalization of esophageal acid exposure; 60% and 89% hiatal hernia reduction; and 62% and 80% esophagitis reduction, respectively. More than 50% of patients with Hill grade I tight valves had a normalized cardia circumference. Resting pressure of the lower esophageal sphincter (LES) was improved significantly (p < 0.001), by 53%. EsophyX-TIF cured GERD in 56% of patients based on their symptom reduction and PPI discontinuation. CONCLUSION: The 12-month results showed that EsophyX-TIF was safe and effective in improving quality of life and for reducing symptoms, PPI use, hiatal hernia, and esophagitis, as well as increasing the LES resting pressure and normalizing esophageal pH and cardia circumference in chronic GERD patients.

Clinical and six-month angiographic evaluation of coronary arterial graft interrupted anastomoses by use of a self-closing clip device: a multicenter prospective clinical trial.

OBJECTIVES: To evaluate the safety and effectiveness of a self-closing surgical clip with an interrupted technique in left internal thoracic artery to left anterior descending artery bypass grafting. METHODS: Eighty-two patients were enrolled and treated (February 2000 through August 2001) in a prospective, nonrandomized, multicenter trial. Left internal thoracic artery to left anterior descending artery anastomoses were performed in 60 off-pump coronary artery bypasses (73%), 12 conventional coronary artery bypass grafting (15%), and 10 minimally invasive direct coronary artery bypass (12%) procedures. Angiograms (64 to 383 days, mean 200 days) were obtained on 63 patients (77%). Qualitative and quantitative angiographic assessment was performed by an independent core laboratory. RESULTS: The self-closing surgical clip was used for 82 left internal thoracic artery to left anterior descending artery interrupted anastomoses without the requirement for knot tying or primary suture management. Minimum left internal thoracic artery to left anterior descending artery anastomosis time was 3 minutes. There was one perioperative and one late death (both not heart related) and one reexploration for bleeding unrelated to the anastomotic site. FitzGibbon grades were as follows: A (n = 60, 95.2%), B (n = 3, 4.8%) including one kinked left internal thoracic artery, and O (n = 0, 0%). Quantitative analysis (n = 57) showed mean lumen diameters of left internal thoracic artery proximal to the anastomosis of 2.1 mm, at anastomosis of 2.0 mm, and in the left anterior descending artery distal to the anastomosis of 1.9 mm. The average ratio of the anastomosis to the left anterior descending artery diameter was 1.14 (0.45 to 1.93). Anastomotic stenosis as a percentage of average left internal thoracic artery to left anterior descending artery diameter was -2.3%, comparing favorably with results (23% to 24%) reported from the Patency, Outcomes, Economics, Minimally invasive direct coronary artery (POEM) bypass study. CONCLUSIONS: The interrupted technique, facilitated by a self-closing anastomotic clip, yields favorable 6-month angiographic results when compared with other published studies.

Six-month angiographic evaluation of beating-heart coronary arterial graft interrupted anastomoses using the coalescent U-CLIP anastomotic device: a prospective clinical study.

BACKGROUND: Interrupted suture technique avoids the "purse string" and puckering effects frequently seen with continuous suture techniques and should represent the standard of care in the creation of high-quality vascular anastomoses. This clinical study evaluated the safety and effectiveness of a self-closing surgical clip (Coalescent Surgical U-CLIP Anastomotic Device [U-CLIP]) designed to facilitate this interrupted technique. Left internal mammary artery (LIMA) to left anterior descending (LAD) coronary bypass grafting was studied. METHODS: Eighteen patients meeting inclusion criteria were enrolled (October 2000 through September 2001) into this prospective study. Anastomoses were performed using a beating-heart median sternotomy procedure (off-pump coronary artery bypass) in 17 cases (94%) and a minimally invasive beating-heart procedure (minimally invasive direct coronary artery bypass [MIDCAB]) in one case (6%). Six-month follow-up was completed on 18 patients (100%), with angiograms performed on 17 patients (94%) at a mean of 179 days (range, 168-191 days). Qualitative and quantitative angiographic assessment was performed by an independent core laboratory. RESULTS: The U-CLIP was used for 18 LIMA-to-LAD interrupted anastomoses without the requirement for knot tying or suture management and with no device-related morbidity or mortality. Mean LIMA-to-LAD anastomosis time was 8.6 minutes (range, 5-14 minutes). All anastomoses were FitzGibbon grade A at 6 months postprocedure. Quantitative analysis showed mean luminal diameters proximal to the anastomosis of 2.32 mm, at the anastomosis of 2.25 mm, and immediately distal to anastomosis of 1.99 mm. The average ratio of anastomosis to LAD diameter was 1.17 (range, 0.93- 1.93). Anastomotic stenosis as a percentage of average LIMA/LAD diameter was a negative 4.2%, comparing favorably with the 23% to 24% reported in the POEM (Patency, Outcomes, Economics of MIDCAB) study. CONCLUSIONS: The interrupted technique, facilitated by a self-closing anastomotic clip, yielded 6-month follow-up and angiographic results that compared favorably with results of other published studies.

Alterations in Phagocyte Function and Periodontal Infection.

A review of phagocytic cells-polymorphonuclear leukocytes and monocytes-in the inflammatory process is presented. Examples of phagocyte defect-related pathology serve as a framework for understanding the role of these cells in periodontal infection. The role of alterations in neutrophil function in localized juvenile periodontitis is presented as a model system for understanding periodontal pathology as a result of host-related functional abnormalities. Two topical alternative hypotheses for periodontal breakdown are presented in which. macrophage control of the chronic lesion is altered by an absence of T cells or the influence of bacterial superantigens. J Periodontol 1996;67:1070-1075.