Title |
Acute Kidney Injury With the RenalGuard System in Patients Undergoing Transcatheter Aortic Valve Replacement The PROTECT-TAVI Trial (PROphylactic effecT of furosEmide-induCed diuresis with matched isotonic intravenous hydraTion in Transcatheter Aortic Valve Implantation)
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Published in |
JACC: Cardiovascular Interventions, September 2015
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DOI | 10.1016/j.jcin.2015.07.012 |
Pubmed ID | |
Authors |
Marco Barbanti, Simona Gulino, Piera Capranzano, Sebastiano Immè, Carmelo Sgroi, Claudia Tamburino, Yohei Ohno, Guilherme F. Attizzani, Martina Patanè, Rita Sicuso, Gerlando Pilato, Alessio Di Landro, Denise Todaro, Emanuela Di Simone, Andrea Picci, Giuliana Giannetto, Giuliano Costa, Wanda Deste, Daniela Giannazzo, Carmelo Grasso, Davide Capodanno, Corrado Tamburino |
Abstract |
The purpose of this study was to investigate the effect of the RenalGuard System (PLC Medical Systems, Milford, Massachusetts) on prevention of acute kidney injury (AKI) in patients undergoing transcatheter aortic valve replacement (TAVR). TAVR is associated with varying degrees of post-procedural AKI. The RenalGuard System is a dedicated device designed for contrast-induced AKI prevention. Whether this device is also effective in patients with severe aortic stenosis undergoing TAVR is unexplored. The present is an investigator-driven, single-center, prospective, open-label, registry-based randomized study that used the TAVR institutional registry of the Ferrarotto Hospital in Catania, Italy, as the platform for randomization, data collection, and follow-up assessment. A total of 112 consecutive patients undergoing TAVR were randomly assigned to hydration with normal saline solution controlled by the RenalGuard system and furosemide (RenalGuard group) or normal saline solution (control group). The primary endpoint was the incidence of Valve Academic Research Consortium-defined AKI in the first 72 h after the procedure. The AKI rate was lower in the RenalGuard group than in the control group (n = 3 [5.4%] vs. n =14 [25.0%], respectively, p = 0.014]. The majority of patients (5.4% vs. 23.2%) developed a mild AKI (stage 1); severe damage (stage 3) occurred only in 1 patient in the control group (0.0% vs. 1.8%). No case of in-hospital renal failure requiring dialysis was reported. No significant differences in terms of mortality, cerebrovascular events, bleeding, and hospitalization for heart failure were noted in both groups at 30 days. Furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVR. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 2 | 67% |
Canada | 1 | 33% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 2 | 67% |
Scientists | 1 | 33% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Japan | 2 | 1% |
Colombia | 1 | <1% |
Germany | 1 | <1% |
Australia | 1 | <1% |
Unknown | 141 | 97% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 22 | 15% |
Student > Bachelor | 16 | 11% |
Other | 15 | 10% |
Student > Doctoral Student | 13 | 9% |
Student > Ph. D. Student | 11 | 8% |
Other | 31 | 21% |
Unknown | 38 | 26% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 72 | 49% |
Nursing and Health Professions | 10 | 7% |
Agricultural and Biological Sciences | 3 | 2% |
Pharmacology, Toxicology and Pharmaceutical Science | 3 | 2% |
Computer Science | 2 | 1% |
Other | 6 | 4% |
Unknown | 50 | 34% |