Totally Implantable IV Treprostinil Therapy in Pulmonary Hypertension Assessment of the Implantation Procedure.

BACKGROUND: Prostacyclins improve symptoms and survival in pulmonary arterial hypertension (PAH). In response to risks associated with external delivery systems, an implantable IV infusion system was developed. A multicenter, prospective, single-arm, clinical trial (DelIVery for PAH) was conducted to evaluate this system for treprostinil in PAH. This analysis describes the findings related to the implant procedure. METHODS: Patients (N = 64) with PAH (World Health Organization group 1) receiving stable IV treprostinil were enrolled. Patients were transitioned to a temporary peripheral IV infusion catheter prior to the procedure. System implantation was performed at 10 centers under general anesthesia or deep IV sedation by clinicians from various specialties. Central venous access was via the cephalic, subclavian, jugular, or axillary vein. Using an introducer and fluoroscopic guidance, the distal tip of the infusion catheter was placed at the superior caval-atrial junction. The catheter was tunneled from the venous access site to an abdominal subcutaneous pocket, where the pump was placed. RESULTS: Of the 64 patients enrolled, four exited prior to implantation. All 60 implant procedures were successful. At baseline, all patients were receiving treprostinil via an external pump at a mean dose of 71.4 ± 27.8 ng/kg/min (range: 22-142 ng/kg/min). The implant averaged 102 ± 32 min (range: 47-184 min). Clinically significant implant procedure-related complications included one pneumothorax, two infections, and one episode of atrial fibrillation. There were three postimplantation catheter dislocations in two patients. Common implant-related events that were not complications included implant site pain (83%) and bruising (17%). CONCLUSIONS: The procedure for inserting a fully implantable system for treprostinil was successfully performed, with few complications. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01321073; URL: www.clinicaltrials.gov.

Effect of Mandatory Centers of Excellence Designation on Demographic Characteristics of Patients Who Undergo Bariatric Surgery.

IMPORTANCE: From February 21, 2006, through September 24, 2013, the Centers for Medicare & Medicaid Services (CMS) required, via the National Coverage Determination manual, that bariatric surgery be performed only in hospitals that had been designated as a Center of Excellence (COE). The effect of this certification requirement on access to bariatric surgery has been reported only anecdotally. OBJECTIVE: To investigate whether the COE certification requirement proved to be a barrier to patients' access to bariatric surgical procedures. DESIGN, SETTING, AND PARTICIPANTS: Using the National Inpatient Sample, we retrospectively identified patients who underwent bariatric surgery from January 1, 2006, through December 31, 2011. EXPOSURE: Bariatric surgery. MAIN OUTCOMES AND MEASURES: Logistic regression and χ² tests were used to examine differences in patients' sociodemographic characteristics over time. RESULTS: A total of 134,227 bariatric surgical patients were identified. The proportion of the population who were older than 64 years increased from 2.9% in 2006 to 7.0% in 2011 (P < .001) and there was a decrease in the proportion of patients who were 49 years and younger (P < .001). The percentage of female patients who underwent bariatric surgery decreased from 80.4% to 78.1% (P < .001) and the percentage of patients who were classified as black, Hispanic, or Asian or Pacific Islander increased from 12.3% to 15.1% (P < .001), 9.7% to 12.5% (P < .001), and 0.3% to 0.4% (P < .001), respectively. The proportion of patients with Medicare increased from 8.5% to 16.3% (P < .001) and those with Medicaid from 6.6% to 11.8% (P < .001). The percentage of patients with private insurance declined from 72.4% to 63.3% (P < .001). The proportion of patients in the lowest income quartile increased from 20.7% to 22.9% (P < .001) while those in the highest income quartile decreased from 25.8% to 23.9% (P < .001). CONCLUSIONS AND RELEVANCE: The COE certification requirement by CMS did not appear to limit access to bariatric surgery. Future studies should determine whether CMS's recent (2013) change in policy (ie, removing the mandatory COE certification for bariatric surgical insurance coverage) might sacrifice patient safety without addressing the real cause of limited access to health care.