Detection of Neuroendocrine Tumors of the Small Bowel by Double Balloon Enteroscopy

Background Neuroendocrine tumors (NET) account for one-third of all small bowel neoplasms. The search for the primary tumor in NET is important, even though it is difficult to localize, as its surgical excision leads to a better prognosis, even in metastasized stages of the disease. The objective of this study was to evaluate the use of double balloon enteroscopy (DBE) for the detection of the primary tumor in patients with NET. Methods Twelve consecutive patients (eight women, four men) with suspected carcinoid syndrome, either metastatic to the liver (n = 5), symptoms of a neuroendocrine tumor with elevated tumor markers (n = 5), or obscure gastrointestinal bleeding (n = 2) underwent DBE for the search of the primary tumor or the source of bleeding. All patients underwent abdominal sonography and a computed tomography (CT) scan, esophagogastroduodenoscopy (EGD), ileocolonoscopy, and octreotide scintigraphy prior to DBE. Capsule endoscopy was performed in four patients. Results A total of 17 DBE were performed in the 12 patients. The CT scan and sonography of the abdomen as well as EGD and ileocolonoscopy were unable to detect the primary tumor in any patient. A submucosal tumor of the ileum or the jejunum could be detected by DBE was detected in seven patients (58%) (anal route, n = 4; oral route, n = 3). In four of these patients (33%) this finding could be confirmed by the surgical resection of a NET. In two patients (17%) with a submucosal ileum protrusion suspicious for NET, laparotomy and intraoperative endoscopy did not confirm the tumor. Conclusions In this study, the diagnostic yield of DBE for primary tumor search in patients with metastatic or suspected NET was 33%. Although endoscopic small bowel investigation by DBE seems to enrich the diagnostic possibilities for the diagnosis of small bowel-NET, at the present time DBE should only be performed in selected cases, possibly based on a positive previous work-up. Michael Bellutti and Lucia C. Fry contributed equally to this paper.     

Double Balloon Technique for Percutaneous Balloon Pulmonary Valvuloplasty: Comparison with Single Balloon Technique

This study was designed to document our results of double balloon pulmonary valvuloplasty and to evaluate if the double balloon technique is preferable to single balloon valvuloplasty in the relief of isolated valvar pulmonic stenosis. Double balloon valvuloplasty in twelve patients reduced the pulmonary valvar gradient from 100.5 ± 28.0 (mean ± SD) to 26.6 ± 12.5 mm Hg (P < 0.001) which remained improved, 17.5 ± 10.2 mm Hg (P < 0.001) at 6 to 14 month follow-up. Single balloon valvuloplasty with equivalent balloon/pulmonary valve annulus ratios (1.19 ± 0.14 vs 1.19 ± 0.15, P > 0.1) in another 12 patients also reduced (P < 0.001) the gradient from 96.3 ± 40.1 to 28.3 ± 17.3 mm Hg immediately following the procedure which at 6 to 13 month follow-up was 12.8 ± 9.9 mm Hg. The right ventricular peak systolic pressures (116.6 ± 24.5 vs 113.8 ± 41.5 mm Hg) and pulmonary valvar gradients (100.5 ± 28.0 vs 96.3 ± 40.1 mm Hg) prior to valvuloplasty, residual right ventricular pressures (47.4 ± 12.2 vs 54.3 ± 14.2 mm Hg) and pulmonary valve gradients (26.6 ± 12.5 vs 28.3 ± 17.3 mm Hg) immediately after valvuloplasty, and residual right ventricular pressures (43.1 ± 10.9 vs 41.1 + 12.5 mm Hg) and pulmonary valvar gradients (17.5 ± 10.2 vs 12.8 ± 9.9 mm Hg) on follow-up were similar (P ± 0.1) in both groups.
These data indicate that results of double balloon valvuloplasty are excellent but not superior to single balloon valvuloplasty. It is suggested that the double balloon valvuloplasty should be used if the pulmonary valve annulus is too large to dilate with a single balloon. There is no need for double balloon valvuloplasty if the pulmonary valve can be dilated with a commercially available single balloon.     

Economic Implications of Potential Changes to Regulatory and Reimbursement Policies for Medical Devices

Objective

To evaluate the impact of regulatory scenarios on the financial viability of medical device companies.

Design

We developed a model to calculate the expected net present value of a hypothetical product throughout preclinical development, clinical testing, regulatory approval, and postmarketing. We tested 3 scenarios: (1) the current regulatory environment; (2) a scenario in which medical devices are subject to the same evidence standards required for pharmaceuticals; and (3) a scenario consistent with the Coverage with Evidence Development: Coverage with Study Participation (CSP) policy proposed by the Centers for Medicare and Medicaid Services, whereby Medicare will pay for beneficiaries to receive new devices that are not currently determined to be “reasonable and necessary” if the patients participate in clinical studies or registries.

Measurements and Main results

When applying assumptions consistent with the implantable cardioverter-defibrillator market, the net present value at the start of development was an estimated $553 million in the current regulatory environment, $322 million in the pharmaceutical scenario, and $403 million in the CSP scenario. Sensitivity analyses showed that the device industry would likely be profitable in all 3 scenarios over a range of assumptions.

Conclusions

The environment in which the medical device industry operates is financially attractive. Furthermore, when compared with the alternative of applying the same evidence standards for pharmaceuticals to medical devices, the CSP policy offers improved financial incentives for medical device companies.

     

An Educational Program to Assist Clinicians in Identifying Elder Investment Fraud and Financial Exploitation

Due to age-related factors and illnesses, older adults may become vulnerable to elder investment fraud and financial exploitation (EIFFE). The authors describe the development and preliminary evaluation of an educational program to raise awareness and assist clinicians in identifying older adults at risk. Participants (n = 127) gave high ratings for the program, which includes a presentation, clinician pocket guide, and patient education brochure. Thirty-five respondents returned a completed questionnaire at the 6-month follow-up, with 69% (n = 24) of those indicating use of the program materials in practice and also reporting having identified 25 patients they felt were vulnerable to EIFFE. These findings demonstrate the value of providing education and practical tools to enhance clinic-based screening of this underappreciated but prevalent problem.     

Enteroscopy and enteroclysis: an improved method for combined procedure

Enteroclysis is generally considered the method of choice for evaluating the small intestine radiographically. The combined procedure of enteroscopy and enteroclysis has been recently described as complimentary techniques for examining the small intestine. This report describes the use of a balloon catheter placed via the enteroscope, which simplifies intubation and further improves the quality of enteroclysis study.     

Enteroscopy: A Method for Detection of Small Bowel Tumors

Small bowel neoplasms are difficult to identify. Conventional roentgenographic methods may report false-negative results in 23-44% of cases. We describe a symptomatic patient with a jejunal leiomyoma detected by enteroscopy after radiographic evaluation was equivocal. Enteroscopy can be an effective diagnostic modality in selected patients with small bowel tumors.