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Concept: Cleveland Clinic

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BACKGROUND: It was the aim of this prospective study to analyze both the feasibility and preliminary results of video-assisted anal fistula treatment (VAAFT) combined with advancement flap repair for complex fistulas in Crohn’s disease. METHODS: All patients with perianal Crohn’s disease suffering from complex fistulas who underwent definitive surgery using VAAFT combined with advancement flap repair were prospectively enrolled in the study. Only complex fistulas with concurrent stable disease and without any evidence of severe inflammatory activity or perianal sepsis were treated using the VAAFT technique. Patients with Crohn’s proctitis or prior proctectomy were not candidates for the procedure. VAAFT was performed by using the VAAFT equipment (Karl Storz, Tuttlingen, Germany). Key steps included visualization of the fistula tract and/or side tracts using the fistuloscope and correct localization of the internal fistula opening under direct vision with irrigation. Diagnostic fistuloscopy was followed by advancement flap repair. In addition to feasibility, primary end points included detection of side tracts, success and continence status (assessed by the Cleveland Clinic Incontinence Score). Success was defined as closure of both internal and external openings, absence of drainage without further intervention and absence of abscess formation. Follow-up information was derived from clinical examination 3, 6 and 9 months postoperatively. RESULTS: Within a 3-month observation period (September to November 2011), VAAFT was attempted in 13 patients with Crohn’s associated complex fistulas. The completion rate was 85 % (11/13). In these 11 patients (median age 34 years, 64 % females), complex fistulas were transsphincteric (8), suprasphincteric (2) and recto-vaginal (1). Forty-six percent (5/11) had concomitant therapy with biologic drugs. In 36 % (4/11), VAAFT was performed with fecal diversion. Median duration of surgery was 22 (range 18-42) minutes. Using VAAFT, additional side tracts not detected preoperatively could be identified in 64 % (7/11). No morbidity occurred. After a mean follow-up of 9 months, the success rate was 82 % (9/11). No deterioration of continence was documented (Cleveland Clinic Incontinence Score 2.4 vs. 1.6, p > 0.05). CONCLUSION: Preliminary results of the addition of the VAAFT technique to advancement flap repair in Crohn’s fistulas demonstrate that this leads to a high identification rate of occult side tracts with encouraging short-term healing rates. Moreover, a completion rate of 85 % seems promising.

Concepts: Ulcerative colitis, Crohn's disease, Fistula, Fecal incontinence, Anal fistula, Abscess, Cleveland, Cleveland Clinic

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Treatment of CMML remains a clinical challenge, with no drug demonstrating clear clinical benefit. Even if azacitidine is approved in the treatment of CMML, its role remains disputed. We report a cohort of 76 CMML patients (according to WHO classification) treated with azacitidine in 3 programs (French AZA compassionate program, Cleveland Clinic Foundation and H. Lee Moffitt Cancer Center). 45% had CMML2, and 55% had splenomegaly and/or WBC counts >13G/L, which are known to be poor prognostic factors in CMML. All patients received AZA for at least one cycle, and the median number of cycles administered was 6. Thirty-three patients (43%) achieved a response according to IWG 2006 criteria, including 13 complete remissions (%). Median survival was 29 months. Increased bone marrow blast percentage and proliferative features of the disease, including splenomegaly and high WBC counts, were significantly associated with shorter survival. By multivariate analysis, only marrow blasts >10% and palpable splenomegaly had prognostic impact on survival. Although promising, the efficacy of azacitidine in advanced CMML needs to be confirmed in a randomized prospective study.

Concepts: Cancer, Bone marrow, Leukemia, Carpal tunnel syndrome, Cycle, Cleveland, Cleveland Clinic, H. Lee Moffitt Cancer Center & Research Institute

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We describe a minimally invasive heart surgery application of the EinsteinVision 2.0 3D high-definition endoscopic system (Aesculap AG, Tuttlingen, Germany) in an 81-year-old man with severe tricuspid valve insufficiency. Fourteen years ago, he underwent a Ross procedure followed by a DDD pacemaker implantation 4 years later for tachy-brady-syndrome. His biventricular function was normal. We recommended minimally invasive tricuspid valve repair. The application of the aformentioned endoscopic system was simple, and the impressive 3D depth view offered an easy and precise manipulation through a minimal thoracotomy incision, avoiding the need for a rib spreading retractor.

Concepts: Heart, Minimally invasive, Right ventricle, Tricuspid valve, Cardiac surgery, Aortic valve, Tricuspid insufficiency, Cleveland Clinic

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Statin therapy is a proven effective treatment of hyperlipidemia. However, a significant number of patients cannot tolerate statins. This study was conducted to review treatment strategies for patients intolerant to statin therapy with a focus on intermittent statin dosing.

Concepts: Statin, Hyperlipidemia, Ezetimibe, Cleveland, Cleveland Clinic, Significant figures, Intolerance

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Aortic valve replacement for calcific aortic valve stenosis is one of the more common cardiac surgical procedures. However, the underlying pathophysiology of calcific aortic valve stenosis is poorly understood. We therefore investigated the histologic findings of aortic valves excised for calcific aortic valve stenosis and correlated these findings with their associated clinical features.

Concepts: Surgery, Tricuspid valve, Left ventricle, Aortic valve, Aortic valve stenosis, Aortic valve replacement, Aortic insufficiency, Cleveland Clinic

2

Pain and anxiety control is critical in dental practice. Moderate sedation is a useful adjunct in managing a variety of conditions that make it difficult or impossible for some people to undergo certain dental procedures. The purpose of this study was to analyze the sedation protocols used in 3 dental specialty programs at the Case Western Reserve University School of Dental Medicine, Cleveland, OH.

Concepts: Dentistry, Ohio, Cleveland Clinic, Case Western Reserve University School of Medicine, Case Western Reserve University, Cleveland Institute of Music, University Circle

1

A recent multicenter study presented 52-week safety and efficacy results from an open-label extension of a randomized, sham-controlled trial for patients with chronic migraine (CM) undergoing peripheral nerve stimulation of the occipital nerves. We present the data from a single center of 20 patients enrolled at the Cleveland Clinic’s Pain Management Department.

Concepts: Action potential, Serotonin, Spinal nerve, Cleveland, Cleveland Clinic

1

BACKGROUND: The International Metastatic Renal-Cell Carcinoma Database Consortium model offers prognostic information for patients with metastatic renal-cell carcinoma. We tested the accuracy of the model in an external population and compared it with other prognostic models. METHODS: We included patients with metastatic renal-cell carcinoma who were treated with first-line VEGF-targeted treatment at 13 international cancer centres and who were registered in the Consortium’s database but had not contributed to the initial development of the Consortium Database model. The primary endpoint was overall survival. We compared the Database Consortium model with the Cleveland Clinic Foundation (CCF) model, the International Kidney Cancer Working Group (IKCWG) model, the French model, and the Memorial Sloan-Kettering Cancer Center (MSKCC) model by concordance indices and other measures of model fit. FINDINGS: Overall, 1028 patients were included in this study, of whom 849 had complete data to assess the Database Consortium model. Median overall survival was 18·8 months (95% 17·6-21·4). The predefined Database Consortium risk factors (anaemia, thrombocytosis, neutrophilia, hypercalcaemia, Karnofsky performance status <80%, and <1 year from diagnosis to treatment) were independent predictors of poor overall survival in the external validation set (hazard ratios ranged between 1·27 and 2·08, concordance index 0·71, 95% CI 0·68-0·73). When patients were segregated into three risk categories, median overall survival was 43·2 months (95% CI 31·4-50·1) in the favourable risk group (no risk factors; 157 patients), 22·5 months (18·7-25·1) in the intermediate risk group (one to two risk factors; 440 patients), and 7·8 months (6·5-9·7) in the poor risk group (three or more risk factors; 252 patients; p<0·0001; concordance index 0·664, 95% CI 0·639-0·689). 672 patients had complete data to test all five models. The concordance index of the CCF model was 0·662 (95% CI 0·636-0·687), of the French model 0·640 (0·614-0·665), of the IKCWG model 0·668 (0·645-0·692), and of the MSKCC model 0·657 (0·632-0·682). The reported versus predicted number of deaths at 2 years was most similar in the Database Consortium model compared with the other models. INTERPRETATION: The Database Consortium model is now externally validated and can be applied to stratify patients by risk in clinical trials and to counsel patients about prognosis. FUNDING: None.

Concepts: Cancer, Oncology, Lung cancer, Database, Chemotherapy, Validation, Renal cell carcinoma, Cleveland Clinic

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Background  Transcatheter heart valve (THV) therapies have shown to be an alternative to surgical valve replacement, especially in high-risk patients requiring redo surgery. However, reports of transcatheter-based interventions in tricuspid valve position are scarce. Case Description  Here, we report a case of successful concomitant transcatheter aortic valve-in-valve (ViV) and tricuspid valve-in-ring (ViR) procedures using a 23-mm CoreValve Evolut R THV (Medtronic, Inc., Minneapolis, Minnesota, United States) in aortic position and a 29-mm SAPIEN3 (Edwards Lifesciences, Inc., Irvine, California, United States) THV in tricuspid position. Conclusion  This case demonstrates feasibility of concomitant transcatheter aortic ViV and tricuspid ViR procedures.

Concepts: Heart, United States, Surgery, Aortic valve, Valvular heart disease, Cleveland Clinic, Irvine, California, Edwards Lifesciences

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The Cleveland Clinic experience with care paths, including their creation and implementation, challenges overcome during development and testing, and outcomes of selected care path evaluations, is described.

Concepts: Cleveland, Cleveland Clinic