Management of end-stage heart failure patients with or without ventricular assist device: an observational comparison of clinical and economic outcomes.

OBJECTIVES: Heart transplantation (HT) and ventricular assist devices (VAD) for the management of end-stage heart failure have not been directly compared. We compare the outcomes and use of resources with these 2 strategies in 2 European countries with different allocation systems. METHODS: We studied 83 patients managed by VAD as the first option in Bad Oeynhausen, Germany (Group I) and 141 managed with either HT or medical therapy, as the first option, in Paris, France (Group II). The primary end-point was 2-year survival. Kaplan-Meier analyses were performed after the application of propensity score weights to mitigate the effects of non-random group assignment. The secondary end-points were resource utilization and costs. Subgroup analyses were performed for patients undergoing HT and patients treated with inotropes at the enrolment time. RESULTS: The Group I patients were more severely ill and haemodynamically compromised, and 28% subsequently underwent HT vs 55% primary HT in Group II, P < 0.001. The adjusted probability of survival was 44% in Group I vs 70% in Group II, P <0.0001. The mean cumulated 2-year costs were €281 361 ± 156 223 in Group I and €47 638 ± 35 061 in Group II, P < 0.0001. Among patients who underwent HT, the adjusted probability of survival in Group I (n = 23) versus Group II (n = 78) was 76% versus 68%, respectively (0.09), though it differed in the inotrope-treated subgroups (77% in Group I vs 67% in Group II, P = 0.04). CONCLUSIONS: HT should remain the first option for end-stage heart failure patients, associated with improved outcomes and better cost-effectiveness profile. VAD devices represent an option when transplant is not possible or when patient presentation is not optimal.

Efficacy of double-balloon enteroscopy for small-bowel polypectomy: clinical and economic evaluation.

BACKGROUND: We evaluated first the feasibility of endoscopic small-bowel polypectomy and second, the economic aspects, by comparing the cost of endoscopic and surgical polyp resection. METHODS: A prospective, observational, multicenter study included 494 patients with positive capsule endoscopy (CE) before double-balloon enteroscopy (DBE). We selected only CE with at least one polyp. The retrospective economic evaluation compared patients treated by DBE or surgery for small-bowel polypectomy. Hospital readmission because of repeat polyp resection or complication-related interventions was noted. The 1-year cost was estimated from the viewpoint of the healthcare system and included procedures, hospital admissions and follow up. RESULTS: CE indicated one or more polyps in 62 (12.5%) patients (32 males, 49 ± 5 years), all of whom underwent a successful DBE exploration. The DBE polyp diagnostic yield was 58%. There were no major complications. A total of 26 (42%) patients in the DBE group and 19 (39%) in the control group required hospital readmission. All readmissions in the DBE group were for repeat procedures to remove all polyps, and in the control group, for surgical complications. The total cost of the initial hospitalization (€4014 ± 2239 DBE versus €11,620 ± 7183 surgery, p < 0.0001) and the 1-year total cost (€8438 ± 9227 DBE versus €13,402 ± 7919 surgery, p < 0.0001) were lower in the DBE group. CONCLUSIONS: Endoscopic polypectomy was efficient and safe. The total cost at 1 year was less for endoscopy than surgery. DBE should be proposed as the first-line treatment for small-bowel polyp resection.

Medical and Economic Evaluation of FOREseal Bioabsorbable Reinforcement Sleeves Compared With Current Standard of Care for Reducing Air Leakage Duration After Lung Resection for Malignancy: A Randomized Trial.

OBJECTIVE: The objective of this study was to determine the efficacy of alginate staple-line reinforcement of fissure openings as compared with stapling alone, with or without tissue sealant or glue, in reducing the incidence and duration of air leakage after pulmonary lobectomy for malignancy. SUMMARY BACKGROUND DATA: No randomized trial evaluating alginate staple-line reinforcement has been performed to date. METHODS: The Staple-line Reinforcement for Prevention of Pulmonary Air Leakage study was a multicenter randomized trial, with blinded evaluation of endpoints. Patients over 18 years of age scheduled for elective open lobectomy or bilobectomy for malignancy were eligible for enrollment. At thoracotomy, patients were deemed ineligible if an unanticipated pneumonectomy was indicated, or if air leakage occurred after the liberation of pleural adhesions. Otherwise, if the fissure was incomplete or the lung had an emphysematous appearance, patients were randomized to either standard management or interventional procedure consisting of fissure opening with linear cutting staplers buttressed with paired alginate sleeves (FOREseal). The number of eligible patients necessary in each randomization arm was estimated to be 190, and an outcomes analysis was performed on an intention-to-treat basis. RESULTS: Of the 611 patients consented to study enrollment, 380 met the inclusion criteria and were randomized. Based on an intention-to-treat analysis, the primary endpoint of air leak duration was not different between the 2 groups: 1 day (range: 0-2 d) in the FOREseal group and 1 day (range: 0-3 d) in the control group (P = 0.8357). In addition, the 2 groups were similar in terms of the proportion of patients presenting with prolonged air leakage (7.8% in the FOREseal group vs 11.3% in the control group, P = 0.264) and the average duration of chest drainage (P = 0.107). Procedure costs were comparable for both groups. CONCLUSIONS: FOREseal did not demonstrate a significant advantage over standard treatment alone.