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Concept: Cleveland


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


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


AIM: This retrospective study aimed to determine functional results of Laparoscopic Ventral Rectopexy (LVR) for rectal prolapse (RP) and symptomatic rectoceles in a large cohort of patients. METHODS: All patients treated between 2004 and 2011 were identified. Relevant patient characteristics were gathered. A questionnaire concerning disease related symptoms as well as the Cleveland Clinic Incontinence Score (CCIS) and Cleveland Clinic Constipation Score (CCCS) was sent to all patients. RESULTS: A total 245 patients were operated. Twelve patients (5%) deceased during follow-up (FU) and were excluded. Remaining patients (224 females, 9 males) were sent a questionnaire. Indications for LVR were: external RP (n=36), internal RP or symptomatic rectocele (n=157) or a combination of symptomatic rectocele and enterocele (n=40). Mean age and follow-up were 62 years (range: 22-89) and 30 months (range 5-83), respectively. Response rate was 64% (150 patients). The complication rate was 4.6% (11 complications). A significant reduction in symptoms of constipation or obstructed defecation syndrome (ODS) was reported (53% of patients before vs. 19% after surgery, P< 0.001). Mean CCCS during FU was 8.1 points (range 0-23, SD ± 4.3). Incontinence was reported in 138 patients (59%) before surgery and in 32 patients after surgery (14%), indicating a significant reduction (P<0.001). Mean CCIS was 6.7 (range 0-19, SD ± 5.2) after surgery. CONCLUSION: A significant reduction of incontinence and constipation or ODS after LVR was observed in this large retrospective study. LVR therefore appears a suitable treatment for RP and rectocele with and without associated enterocele. © 2013 The Authors. Colorectal Disease © 2013 The Association of Coloproctology of Great Britain and Ireland.

Concepts: Surgery, Colorectal cancer, Colon, Constipation, Rectum, United Kingdom of Great Britain and Ireland, Defecation, Cleveland


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


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


In February 2016, the Cleveland Clinic initiated the first attempt at cadaveric uterine transplantation (UTx) in the United States. The transplantation was ultimately unsuccessful, but it opened doors for further research on both live and cadaveric UTx. While initial strides toward successful transplantation have been made, questions persist on the ethics of UTx: whether the uterus is a vital organ, whether we should prioritize live or cadaveric options, and how the procedure should be covered by health insurance. If we agree that the goal of the medical profession is both to treat and improve quality of life, then the question of whether or not infertility is considered a disease becomes inconsequential in the discussion. As such, the medical enterprise should move forward with research in UTx. In doing so, considering the ethical implications of UTx remains essential-and we must remember to pair innovation with regulation.

Concepts: Medicine, United States, Physician, Ethics, Larynx, Business ethics, Organs, Cleveland


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


The aim of the present study was to create a unique risk adjustment model for surgical site infection (SSI) in patients who underwent colorectal surgery (CRS) at the Cleveland Clinic (CC) with inherent high risk factors by using a nationwide database.

Concepts: Medicine, Hospital, Physician, Antiseptic, Tertiary referral hospital, Cleveland, Cleveland Clinic


Successful implantation of a total artificial heart relies on multiple standardized procedures, primarily the resection of the native heart, and exacting preparation of the atrial and vascular conduits for pump implant and activation. Achieving secure pump connections to inflow/outflow conduits is critical to a successful outcome. During the connection process, however, air may be introduced into the circulation, traveling to the brain and multiple organs. Such air emboli block blood flow to these areas and are detrimental to long-term survival. A correctly managed pump-to-conduit connection prevents air from collecting in the pump and conduits. To further optimize pump-connection techniques, we have developed a novel connecting sleeve that enables airless connection of the Cleveland Clinic continuous-flow total artificial heart (CFTAH) to the conduits. In this brief report, we describe the connecting sleeve design and our initial results from two acute in vivo implantations using a scaled-down version of the CFTAH.

Concepts: Blood, Heart, Circulatory system, Atrium, Implantation, Cleveland, Cleveland Clinic, Artificial heart


The purpose of this study was to evaluate the effects of sinusoidal pump speed modulation of the Cleveland Clinic continuous-flow total artificial heart (CFTAH) on hemodynamics and pump flow in an awake chronic calf model. The sinusoidal pump speed modulations, performed on the day of elective sacrifice, were set at ±15 and ± 25% of mean pump speed at 80 bpm in four awake calves with a CFTAH. The systemic and pulmonary arterial pulse pressures increased to 12.0 and 12.3 mmHg (±15% modulation) and to 15.9 and 15.7 mmHg (±25% modulation), respectively. The pulsatility index and surplus hemodynamic energy significantly increased, respectively, to 1.05 and 1346 ergs/cm at ±15% speed modulation and to 1.51 and 3381 ergs/cm at ±25% speed modulation. This study showed that it is feasible to generate pressure pulsatility with pump speed modulation; the platform is suitable for evaluating the physiologic impact of pulsatility and allows determination of the best speed modulations in terms of magnitude, frequency, and profiles.

Concepts: Coronary artery disease, Cardiology, Heart, Pulse, Vein, Cleveland, Cleveland Clinic, Artificial heart