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Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study
D. Scott Lim Saibal Kar Konstantinos Spargias Robert M. Kipperman William W. O’Neill Martin K.C. Ng Neil P. Fam Darren L. Walters John G. Webb Robert L. Smith Michael J. Rinaldi Azeem Latib Gideon N. Cohen Ulrich Schäfer Leo Marcoff Prashanthi Vandrangi Patrick Verta Ted E. Feldman 《JACC: Cardiovascular Interventions》2019,12(14):1369-1378
ObjectivesThe authors report the procedural and 30-day results of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences, Irvine, California) in patients with mitral regurgitation (MR) enrolled in the multicenter, prospective, single-arm CLASP study.BackgroundSevere MR may lead to symptoms, impaired quality of life, and reduced functional capacity when untreated.MethodsEligible patients had grade 3+ or 4+ MR despite optimal medical therapy and were deemed appropriate for the study by the local heart team. All outcomes were assessed through 30 days post-procedure. Major adverse events (MAEs) were adjudicated by an independent clinical events committee, and echocardiographic images were assessed by a core laboratory. The primary safety endpoint was the rate of MAEs at 30 days.ResultsBetween June 2017 and September 2018, 62 patients with grade 3+ or 4+ MR were enrolled. The mean age was 76.5 years, and 51.6% of patients were in New York Heart Association functional class III or IV, with 56% functional, 36% degenerative, and 8% mixed MR etiology. At 30 days, the MAE rate was 6.5%, with an all-cause mortality rate of 1.6% and no occurrence of stroke; 98% had MR grade ≤2+, with 86% with MR grade ≤1+ (p < 0.0001); and 85% were in New York Heart Association functional class I or II (p < 0.0001). Six-minute walk distance improved by 36 m (p = 0.0018), and Kansas City Cardiomyopathy Questionnaire and EQ-5D scores improved by 17 (p < 0.0001) and 10 (p = 0.0004) points, respectively.ConclusionsThe PASCAL repair system showed feasibility and acceptable safety in the treatment of patients with grade 3+ or 4+ MR. MR severity, irrespective of etiology, was significantly reduced and accompanied by clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study; NCT03170349) 相似文献
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Assimakopoulos SF Thomopoulos KC Louvros E Theocharis G Giannikoulis C Katsakoulis E Nikolopoulou VN 《The American journal of the medical sciences》2008,336(1):21-26
BACKGROUND: During the past years, major advances in the management of upper gastrointestinal diseases have been achieved. The aim of this study was to determine if changes in indications for upper gastrointestinal endoscopy and endoscopic findings have occurred during the last 15 years in our area. METHODS: Indications for upper gastrointestinal tract endoscopy and endoscopy findings of patients who underwent upper endoscopy in years 1990, 1995, 2000, and 2005 in our department were compared. RESULTS: Over the 15-year period, the number of diagnostic endoscopies performed in our department in years 1990, 1995, 2000, and 2005 increased (953, 1245, 2350, and 2528, respectively). Acute upper gastrointestinal bleeding had become less frequent (40%, 42.8%, 19.7%, 14.3%, P<0.001), but dyspepsia (24.4%, 33.6%, 54.3%, 51.3%, P=0.002) and reflux (1.8%, 1.3%, 5.1%, 10.8%, P=0.005) more frequent indications for upper endoscopy. The endoscopic findings of duodenal ulcer (39.1%, 22.5%, 20.5%, 9.3%, P<0.001), gastric ulcer (15.9%, 8.3%, 5.7%, 4.6%, P=0.036) as well as erosive gastroduodenitis (35.6%, 22.2%, 15.3%, 4.7%, P<0.001) decreased, whereas that of reflux esophagitis (3.1%, 10.1%, 12%, 16%, P=0.034) increased. Moreover, the percentage of patients with negative endoscopy or minimal endoscopic findings (eg, nonerosive gastritis) increased (12.8%, 33.7%, 54.1%, 64.4%, P<0.001). CONCLUSIONS: In south-western Greece, dyspepsia and reflux as an indication for upper endoscopy have been increasing, whereas acute upper gastrointestinal bleeding has been decreasing. The finding of peptic ulcers at the upper gastrointestinal tract endoscopy has become significantly less frequent, while the percentage of patients with negative results of endoscopy seems to have been increasing rapidly. 相似文献
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Mimidis K Papadopoulos V Katsinelos P Deftereos S Filippou D Kartalis G 《Romanian journal of gastroenterology》2004,13(1):39-41
Gastrocolic fistula is rarely described in the literature. It has been associated with a variety of diseases and recently with benign gastric ulcers related to the use of nonsteroidal anti-inflammatory drugs (NSAIDs'). The present case represents the first report of gastrocolic fistula due to NSAIDs in a cirrhotic patient. This is in keeping with the established knowledge that cirrhotic patients constitute a high-risk group of patients when treated with NSAIDs'. Review of the literature shows that this condition warrants a complete diagnostic work-up to exclude more ominous underlined diseases. 相似文献
77.
Theodossios P Perdikides Efthimios D Avgerinos Konstantinos Lagios Peter Ziegler Wolf Stelter 《Journal of endovascular therapy》2007,14(5):634-638
PURPOSE: To report the technique for deploying a 3-part endovascular graft onto the native aortic bifurcation for greater stent-graft stability. TECHNIQUE: The Zenith Composite Endovascular Graft is a 3-part system consisting of a proximal tubular body with an uncovered Gianturco Z stent, a distal bifurcated body, and a contralateral leg. Proximally, 8-mm flexible interstent gaps facilitate precise infrarenal aortic placement, even in angulated necks. Technically, the bifurcated part is deployed first and pulled down to the aortic bifurcation, while the tubular main body and contralateral leg deployment follow. Using this technique to accommodate the graft onto the natural aortic bifurcation, distal stability can be enhanced and graft migration minimized. CONCLUSION: The Composite configuration can be an alternative to ensure a higher security index in difficult anatomies. It may be beneficial in patients with short (10-15 mm), angulated (>60 degrees ), or conical necks and deserves investigation in these patient populations. 相似文献
78.
Vasilakopoulou A Dimarongona K Samakovli A Papadimitris K Avlami A 《Scandinavian journal of infectious diseases》2003,35(2):144-146
A fatal case is reported of Balantidium coli pneumonia in a 71-y-old woman suffering from anal cancer. The diagnosis was made by the discovery of motile trophozoites in a wet mount from bronchial secretions. The usual habitat of the parasite is the colon; lung balantidiasis is very rare. 相似文献
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