Temporal trends in cardiovascular outcomes and costs among patients with type 2 diabetes.

BACKGROUND: Type 2 diabetes (T2D) is a strong risk factor for cardiovascular (CV) disease. CV outcomes in T2D have generally been improving over time but recent data from the US suggest attenuation of trends in older adults with reversal of trends in younger adults. However, published data are only reported through 2015. OBJECTIVES: To quantify trends over time in CV outcomes from 2001 to 2018, and describe changes over time in health care costs in T2D. METHODS: This retrospective cohort study incorporated data from a regional health insurance plan. Study outcomes included acute myocardial infarction (AMI), ischemic stroke, hemorrhagic stroke, heart failure hospitalization (HFH), percutaneous coronary intervention, coronary artery bypass surgery, and all-cause mortality. Poisson regression estimated rate ratios across the entire 17-year study period (RR17). RESULTS: Among 79,392 T2D members tracked on average 4.1 years, overall trends in AMI (RR17 = 0.69; 95% CI: 0.64, 0.74), HFH (RR17 = 0.82; 0.79, 0.86), and all-cause mortality (RR17 = 0.87; 0.84, 0.91) improved while ischemic stroke (RR17 = 2.36; 2.16, 2.57) worsened. For AMI, HFH, and all-cause mortality, trends in older age groups were significantly better than in younger age groups (interaction P-values < .001). Health care costs related to pharmaceuticals (+15%/year) and emergency department (ED) visits (>15%/year) increased at faster rates than other utilization metrics (+10%/year). CONCLUSIONS: In T2D, overall trends in most CV outcomes improved but smaller improvements or worsening trends were observed in younger patients. Health care costs accelerated at faster rates for medications and ED visits.

Long-term retention of endoscopically placed hydrogel prostheses at the lower esophageal sphincter in pigs.

BACKGROUND: Using flexible endoscopic methods, hydrogel prostheses can be safely placed, retained for long periods of time, and removed from the esophageal submucosa of pigs. This new technique may have future applications in the treatment of gastroesophageal reflux disease in selected situations. METHODS: In a controlled, prospective trial, farm pigs ( n = 28) or Sinclair mini-swine ( n = 18) underwent sequential placements of 2-13 pliable, radio-opaque hydrogel prostheses into the submucosa of the esophagus during a single endoscopy session. A novel endoscope-overtube device was used. Followup endoscopy and/or fluoroscopy sessions were video-recorded at 6-week, 12-week, 6-month, and yearly intervals. The endoscopic removal of hydrogels was tested in vivo. Necropsy specimens were inspected for signs of chronic inflammation. RESULTS: Overall, 98% of delivery attempts were successful (288/293). Only three hydrogels were lost after 6 weeks. Short-term animals ( n = 36) retained 88% of hydrogels for periods up to 6 months. Intact hydrogels ( n = 12) were easily removed from four animals at endoscopy. Long-term subjects had two or three hydrogels per animal, using either a beveled-needle device (six pigs) or a trocar design (four pigs). Trocar design: nine of nine prostheses retained at 3 years (100%). Needle design: nine of 10 prostheses retained at 3 years (90%). No significant adverse event occurred. Growth curves were similar between groups. All hydrogels remained pliable to gross inspection upon in vivo removal or necropsy. Pathology showed minimal fibrosis and no chronic inflammation. CONCLUSIONS: A novel endoscopic overtube device allows for the successful delivery of multiple hydrogel prostheses with acceptable safety and long term retention rates. These hydrogel prostheses can also be easily removed from the submucosal space of the esophagus.

Endoscopic prosthesis augmentation of the lower esophageal sphincter in swine.

HYPOTHESIS: Endoscopically delivered prostheses are safe, durable, and may augment a defective lower esophageal sphincter (LES). METHODS: Pigs were studied as normal-LES or LES-weakened animals. A novel endoscopic delivery system was developed in order to place multiple hydrogel prostheses into the LES submucosa. Histopathology sections evaluated ultimate durability and the relationship of the prostheses to esophageal anatomy. RESULTS: Overall, 97% of 179 prosthesis delivery attempts were successful. LES-weakened animals had LES pressures return to normal or supranormal values at 2 weeks and 2 months after prosthesis augmentation. Weakened gastric yield pressures improved to normal values at 2 weeks after prosthesis augmentation. The thickness of the muscular layers and the mucosal integrity of the esophagus was unaffected by the retained prostheses. CONCLUSIONS: Endoscopically delivered hydrogel prostheses are safe and durable. These prostheses can successfully augment a defective sphincter without recognizable damage to the esophagus.