Suture-Mediated Patent Foramen Ovale Closure Using the NobleStitch EL: Results from a Hospital-Based HTA.

(1) Background: Patent foramen ovale (PFO) is a congenital abnormality present in up to 25% of the general population, and it is a relevant cause of cryptogenic stroke. We applied the hospital-based HTA model (AdHopHTA) to conduct a multidimensional assessment of NobleStitch EL, an innovative suture-mediated PFO closure device. We compared it to Amplatzer PFO Occluder (APO) to provide evidence to inform technologies' governance in hospital settings. (2) Methods: For each AdHopHTA dimension we: systematically retrieved available evidence from the literature applying the PRISMA guidelines and then analyzed original clinical and cost data of a NobleStitch EL device at San Raffaele research hospital in Milan (Italy). The economic dimension was analyzed through activity-based costing and a cost analysis. We conducted semi-structured interviews with selected healthcare professionals to explore the organizational, legal, social, and ethical impact. (3) Results: A single study was included for the NobleStitch EL, with 10 for APO. Both literature data and original data showed comparable safety. Efficacy data analysis found that the PFO closure was at 89% for NobleStitch EL vs. 89-97% for APO. APO has a better impact on the budget and minor process costs. Consulted experts reported that the organizational impact of NobleStitch EL in the short and the long run as null, albeit a better impact under the social and the ethical aspects. (4) Conclusion: We suggest that there is inadequate evidence to conclude the relative efficacy of NobleStitch EL as compared to APO. Nevertheless, this report shows a good safety profile and higher costs for NobleStitch EL, with no organizational or legal impact. Further studies in selected population are recommended.

Clinical and economic validation of grade B postoperative pancreatic fistula subclassification.

BACKGROUND: Grade B postoperative pancreatic fistula represents the largest fraction of postoperative pancreatic fistula. A subclassification of grade B postoperative pancreatic fistula has been recently proposed and seems to better stratify postoperative pancreatic fistula clinical and economic burden. Aim of this study was to validate, from a clinical and economic standpoint, grade B postoperative pancreatic fistula subclassification in patients submitted to pancreaticoduodenectomy. METHODS: All consecutive patients who underwent pancreaticoduodenectomy and developed biochemical leak or postoperative pancreatic fistula were included. Grade B postoperative pancreatic fistula was subclassified into 3 categories (B1: persistent drainage >21 days, B2: pharmacological treatments; B3: interventional procedures). Postoperative pancreatic fistula clinical and economic burden was assessed by evaluating postoperative complications, length of hospital stay, and overall hospital costs. RESULTS: Overall, 289 patients developed biochemical leak or postoperative pancreatic fistula. Of these, 34 had biochemical leak (12%), 25 had grade B1 postoperative pancreatic fistula (9%), 91 had grade B2 postoperative pancreatic fistula (31%), 94 had grade B3 postoperative pancreatic fistula (32%), and 45 experienced grade C postoperative pancreatic fistula (16%). The severity of postoperative complications significantly increased across biochemical leak and postoperative pancreatic fistula categories (P < .001), but it was comparable between biochemical leak and grade B1 postoperative pancreatic fistula. There was no significant difference in terms of length of hospital stay between patients with biochemical leak and those with grade B1 postoperative pancreatic fistula (P = 1.000). Overall hospital costs were similar for patients with biochemical leak and those with grade B1 postoperative pancreatic fistula (P = 1.000), whereas they significantly increased across all the other postoperative pancreatic fistula subgroups. CONCLUSION: A subclassification of grade B postoperative pancreatic fistula can better stratify the increasing clinical burden and economic impact of postoperative pancreatic fistula after pancreaticoduodenectomy. Grade B1 postoperative pancreatic fistula has minimal clinical and economic consequences and can be considered closer to a biochemical leak than to a grade B2 postoperative pancreatic fistula.