Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction (REDUCE LAP-HF I [Reduce Elevated Left Atrial Pressure in Patients With Heart Failure])
| العنوان: | Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction (REDUCE LAP-HF I [Reduce Elevated Left Atrial Pressure in Patients With Heart Failure]) |
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| المؤلفون: | Anupam Basuray, Ted Feldman, Martin Penicka, Sanjiv J. Shah, Rhondalyn Forde-McLean, Mark C. Petrie, Peter S. Fail, Pim van der Harst, Scott Lilly, Sheldon E. Litwin, Rami Kahwash, Mark J. Ricciardi, Joseph M. Massaro, Laura Mauri, David M. Kaye, Christopher D. Nielsen, Daniel Burkhoff, Scott L. Hummel |
| المساهمون: | Cardiovascular Centre (CVC) |
| المصدر: | Circulation, 137(4), 364-375. LIPPINCOTT WILLIAMS & WILKINS |
| بيانات النشر: | LIPPINCOTT WILLIAMS & WILKINS, 2018. |
| سنة النشر: | 2018 |
| مصطلحات موضوعية: | Male, Cardiac Catheterization, Time Factors, 030204 cardiovascular system & hematology, hemodynamics, Cardiac Catheters, Ventricular Function, Left, law.invention, Atrial Pressure, 0302 clinical medicine, Randomized controlled trial, law, Medicine, Prospective Studies, 030212 general & internal medicine, Exercise Tolerance, Ejection fraction, Diastolic heart failure, Middle Aged, investigational therapies, Europe, Treatment Outcome, Ambulatory, SIMULATION, Cardiology, Atrial Function, Left, Female, Cardiology and Cardiovascular Medicine, medicine.medical_specialty, EXERCISE, Prosthesis Design, 03 medical and health sciences, Physiology (medical), Multicenter trial, Internal medicine, Humans, Pulmonary Wedge Pressure, Pulmonary wedge pressure, Aged, Heart Failure, HYPERTENSION, business.industry, diastolic heart failure, Australia, Stroke Volume, Recovery of Function, medicine.disease, United States, Surgery, Heart failure, randomized controlled trial, Heart-Assist Devices, business, Heart failure with preserved ejection fraction |
| الوصف: | 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.govTest . Unique identifier: NCT02600234. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1524-4539 0009-7322 0260-0234 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c61c3b2e073807cc17704a9709f6ac77Test https://doi.org/10.1161/CIRCULATIONAHA.117.032094Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....c61c3b2e073807cc17704a9709f6ac77 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15244539 00097322 02600234 |
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