Search

Background: In nonrandomized, open-label studies, a transcatheter interatrial shunt device (IASD, Corvia Medical) was associated with lower pulmonary capillary wedge pressure (PCWP), fewer symptoms, and greater quality of life and exercise capacity in patients with heart failure (HF) and midrange or preserved ejection fraction (EF ≥40%). We conducted the first randomized sham-controlled trial to evaluate the IASD in HF with EF ≥40%., Methods: REDUCE LAP-HF I (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure) was a phase 2, randomized, parallel-group, blinded multicenter trial in patients with New York Heart Association class III or ambulatory class IV HF, EF ≥40%, exercise PCWP ≥25 mm Hg, and PCWP-right atrial pressure gradient ≥5 mm Hg. Participants were randomized (1:1) to the IASD versus a sham procedure (femoral venous access with intracardiac echocardiography but no IASD placement). The participants and investigators assessing the participants during follow-up were blinded to treatment assignment. The primary effectiveness end point was exercise PCWP at 1 month. The primary safety end point was major adverse cardiac, cerebrovascular, and renal events at 1 month. PCWP during exercise was compared between treatment groups using a mixed-effects repeated measures model analysis of covariance that included data from all available stages of exercise., Results: A total of 94 patients were enrolled, of whom 44 met inclusion/exclusion criteria and were randomized to the IASD (n=22) and control (n=22) groups. Mean age was 70±9 years, and 50% were female. At 1 month, the IASD resulted in a greater reduction in PCWP compared with sham control ( P =0.028 accounting for all stages of exercise). Peak PCWP decreased by 3.5±6.4 mm Hg in the treatment group versus 0.5±5.0 mm Hg in the control group ( P =0.14). There were no peri-procedural or 1-month major adverse cardiac, cerebrovascular, and renal events in the IASD group and 1 event (worsening renal function) in the control group ( P =1.0)., Conclusions: In patients with HF and EF ≥40%, IASD treatment reduces PCWP during exercise. Whether this mechanistic effect will translate into sustained improvements in symptoms and outcomes requires further evaluation., Clinical Trial Registration: URL: https://clinicaltrials.gov. Unique identifier: NCT02600234., (© 2017 American Heart Association, Inc.)

Background: July 2011 saw the implementation of the newest duty hour restrictions, further limiting the working hours of first year residents and necessitating a variety of adaptations on the part of residency programs. The present study sought to characterize the perceived impact of these restrictions on residency program personnel using a multi-specialty and multi-site approach., Methods: We developed and administered a survey to internal medicine and general surgery residency programs at three academic medical centers within an urban region. The survey combined quantitative and qualitative components to gain a broader understanding of the impact of the newest regulations. Quantitative responses were compared between Internal Medicine and General Surgery programs with Student t-tests. Other comparisons were performed using ANOVA or Kruskal-Wallis testing as appropriate. For all comparisons, the threshold for significance was set at 0.01. Two independent reviewers coded all qualitative data and assigned one or more themes based on content. Descriptive statistics were calculated and the diversity of themes identified. No between-group comparisons were conducted with the qualitative data., Results: We found significant differences in the overall perceptions of duty hour restrictions across specialty (internal medicine more positive than general surgery) and across position (first year residents more positive than senior residents and faculty). Notably, individuals who trained at osteopathic medical schools reported significantly more negative views of the duty hour restrictions than those who had trained at allopathic or international medical schools, suggesting an influence of undergraduate medical training. The complementary qualitative data offered insights into the perceived strengths and weaknesses of the duty hour restrictions, as well as actionable suggestions that could help to improve residency program function., Conclusion: This study characterizes responses to the new duty hour restrictions from a variety of perspectives. Our findings show that individual (type of undergraduate medical education, role in graduate medical education) and program-wide (e.g., specialty) factors contribute to participant satisfaction with DHR. This research highlights the value of a mixed methods approach in the study of duty hour restrictions, with our qualitative arm yielding rich data that complemented and expanded upon the insights derived from the quantitative data.