Sigle-center, observational, prospective study describing same-day discharge implementation for uncomplicated elective percutaneous coronary intervention by radial approach: Study protocol
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Published:
Sep 30, 2021
Keywords:
angioplasty, coronary disease, costs and cost analysis, patient discharge
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Abstract
Objectives: The study's primary objective will be to evaluate the safety and describe the initial experience of implementing early discharge (on the same day) of coronary patients from the Unified Health System undergoing elective, uncomplicated, transradial percutaneous coronary intervention. The secondary objective will be to assess the impact on the direct cost per patient compared to previously known data from the classic hospital stay used (hospital overnight). Methods: Observational and prospective study of patients undergoing elective uncomplicated transradial percutaneous coronary intervention with early discharge, respecting the inclusion and exclusion criteria. Follow-up of patients will be carried out to prove the safety of the new strategy in the population of the Unified Health System and to compare the direct costs between overnight stays and discharge on the same day. This will be the first study dedicated to primarily evaluating the safety of early discharge after elective uncomplicated transradial coronary angioplasty, validating this protocol in the population of the Brazilian public health system.
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1.
Aquino GSL de M, Botelho JB, Matsuda CN, Silva MA da, Janella BL. Sigle-center, observational, prospective study describing same-day discharge implementation for uncomplicated elective percutaneous coronary intervention by radial approach: Study protocol. Health Sci J [Internet]. 2021Sep.30 [cited 2024Apr.25];11(3):6-13. Available from: https://portalrcs.hcitajuba.org.br/index.php/rcsfmit_zero/article/view/1123
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References
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14. Bundhun PK, Soogund MZS, Huang W-Q. same day discharge versus overnight stay in the hospital following percutaneous coronary intervention in patients with stable coronary artery disease: a systematic review and meta-analysis of randomized controlled tri-als. PLoS One. 2017;12(1):e0169807. https://doi.org/10.1371/journal.pone.0169807
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16. Madan M, Bagai A, Overgaard CB, Fang J, Koh M, Cantor WJ, et al. Same-day discharge after elective percutaneous coronary interventions in Ontario, Canada. J Am Heart Assoc. 2019;8(13):e012131. https://doi.org/10.1161/JAHA.119.012131
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18. Jabara R, Gadesam R, Pendyala L, Chronos N, Crisco L V, King SB, et al. Ambulatory discharge after transradial coronary inter-vention: Preliminary US single-center experience (Same-day TransRadial Intervention and Discharge Evaluation, the STRIDE Stu-dy). Am Heart J. 2008;156(6):1141-6. https://doi.org/10.1016/j.ahj.2008.07.018
19. Small A, Klinke P, Della Siega A, Fretz E, Kinloch D, Mildenberger R, et al. Day procedure intervention is safe and complication free in higher risk patients undergoing transradial angioplasty and stenting. The discharge study. Catheter Cardiovasc Interv. 2007;70(7):907-12. https://doi.org/10.1002/ccd.21277
20. Biasco L, Pedrazzini GB, Araco M, Petracca F, Del Monte D, Sürder D, et al. Evaluation of a protocol for same-day discharge after radial lounge monitoring in a southern Swiss referral percutaneous coronary intervention centre. J Cardiovasc Med (Hagers-town). 2017;18(8):590-5. https://doi.org/10.2459/JCM.0000000000000519
21. Koshy SKG, George LK, Das P. Cost-effectiveness and outcomes with early or same-day discharge after elective percutaneous coronary intervention. Curr Cardiol Rep. 2020;22(6):42. https://doi.org/10.1007/s11886-020-01286-1
22. Rodriguez-Araujo G, Cilingiroglu M, Mego D, Hakeem A, Lendel V, Cawich I, et al. Same versus next day discharge after elective transradial PCI: The RAdial SAme Day DischArge after PCI trial. (The RASADDA-PCI trial). Cardiovasc Revasc Med. 2018;19(6S):7-11. https://doi.org/10.1016/j.carrev.2018.05.020
23. Lopez JJ, Ebinger JE, Allen S, Yildiz M, Henry TD. Adapting STEMI care for the COVID-19 pandemic: The case for low-risk STEMI triage and early discharge. Catheter Cardiovasc Interv. 2020;1:1-3. https://doi.org/10.1002/ccd.28993
24. Seto AH, Shroff A, Abu-Fadel M, Blankenship JC, Boudoulas KD, Cigarroa JE, et al. Length of stay following percutaneous coro-nary intervention: An expert consensus document update from the society for cardiovascular angiography and interventions. Ca-theter Cardiovasc Interv. 2018;92(4):717-31. https://doi.org/10.1002/ccd.27637
25. Borges Santos M. Same-day discharge after elective percutaneous transluminal coronary angioplasty: An instruction manual and call for increased uptake in a burdened National Health Service. Rev Port Cardiol. 2020;39(8):451-2. https://doi.org/10.1016/j.repc.2020.07.002
26. Mehran R, Rao S V, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011;123(23):2736-47. https://doi.org/10.1161/CIRCULATIONAHA.110.009449
27. Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, et al. Standardized end point definitions for coronary intervention trials: The Academic Research Consortium-2 Consensus Document. Eur Heart J. 2018;39(23):2192-207. https://doi.org/10.1093/eurheartj/ehy223
28. Bouleti C, Mewton N, Germain S. The no-reflow phenomenon: State of the art. Arch Cardiovasc Dis. 2015;108(12):661-74. https://doi.org/10.1016/j.acvd.2015.09.006
29. Barbeau GR, Arsenault F, Dugas L, Simard S, Larivière MM. Evaluation of the ulnopalmar arterial arches with pulse oximetry and plethysmography: comparison with the Allen's test in 1010 patients. Am Heart J. 2004;147(3):489-93. https://doi.org/10.1016/j.ahj.2003.10.038
30. Jirous S, Bernat I, Slezak D, Miklik R, Rokyta R. Post-procedural radial artery occlusion and patency detection using duplex ultra-sound vs. the reverse Barbeau test. Eur Heart J Suppl. 2020;22(Suppl F):F23-9. https://doi.org/10.1093/eurheartj/suaa095
31. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, Van Es G-A, et al. Clinical end points in coronary stent trials a case for standardized definitions. Circulation [Internet]. 2007;115:2344-51. https://doi.org/10.1161/CIRCULATIONAHA.106.685313
32. Cox LS, Sanchez-Borges M, Lockey RF. World Allergy Organization Systemic Allergic Reaction Grading System: Is a Modification Needed? J Allergy Clin Immunol Pract. 2017;5(1):58-62.e5. https://doi.org/10.1016/j.jaip.2016.11.009
2. Jia S, Liu Y, Yuan J. Evidence in guidelines for treatment of coronary artery disease. Adv Exp Med Biol. 2020;1177:37-73.https://doi.org/10.1007/978-981-15-2517-9_2
3. Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, et al. Heart Disease and Stroke Statistics-2020 Update: A report from the American Heart Association. Circulation. 2020;141(9):e139-596. https://doi.org/10.1161/cir.0000000000000757
4. Gholami SS, Azar FEF, Rezapour A, Tajdini M. Cost-effectiveness of coronary artery bypass graft and percutaneous coronary intervention compared to medical therapy in patients with coronary artery disease: a systematic review. Heart Fail Rev. 2019;24(6):967-75. https://doi.org/10.1007/s10741-019-09811-3
5. Silva EN, Silva MT, Pereira MG. Estudos de avaliação econômica em saúde: definição e aplicabilidade aos sistemas e serviços de saúde. Epidemiol Serv Saúde. 2016;25(1): 205-7. https://doi.org/10.5123/S1679-49742016000100023
6. Shepard DS. Cost-effectiveness in Health and Medicine. Gold MR, Siegel JE, Russell LB, Weinstein MC (eds). New York: Oxford University Press, 1996. J Ment Health Policy Econ [Internet]. 1999;2(2):91-2. https://doi.org/10.1002/(SICI)1099-176X(199906)2:2<91::AID-MHP46>3.0.CO;2-I
7. Chambers CE, Dehmer GJ, Cox DA, Harrington RA, Babb JD, Popma JJ, et al. Defining the length of stay following percutaneous coronary intervention: an expert consensus document from the Society for Cardiovascular Angiography and Interventions. Endor-sed by the American College of Cardiology Foundation. Catheter Cardiovasc Interv. 2009 ;73(7):847-58. https://doi.org/10.1002/ccd.22100
8. Voudris K V, Georgiadou P, Charitakis K, Marmagkiolis K. Radial Interventions: Present and Future Indications. Curr Treat Options Cardiovasc Med. 2016;18(1):2. https://doi.org/10.1007/s11936-015-0429-3
9. Ferrante G, Rao S V, Jüni P, Da Costa BR, Reimers B, Condorelli G, et al. Radial versus femoral access for coronary interventions across the entire spectrum of patients with coronary artery disease: a meta-analysis of randomized trials. JACC Cardiovasc In-terv. 2016;9(14):1419-34. https://doi.org/10.1016/j.jcin.2016.04.014
10. Steiner CA, Karaca Z, Moore BJ et al. Surgeries in hospital-based ambulatory surgery and hospital inpatient settings, 2014: Statis-tical Brief #223 [Internet]. 2014. Available from: https://www.ncbi.nlm.nih.gov/books/NBK442035/
11. Abdelaal E, Rao S V, Gilchrist IC, Bernat I, Shroff A, Caputo R, et al. Same-day discharge compared with overnight hospitalization after uncomplicated percutaneous coronary intervention: a systematic review and meta-analysis. JACC Cardiovasc Interv. 2013 [cited 2021 Aug 4];6(2):99-112. https://doi.org/10.1016/j.jcin.2012.10.008
12. Amin AP, Pinto D, House JA, Rao S V, Spertus JA, Cohen MG, et al. Association of same-day discharge after elective percutane-ous coronary intervention in the United States with costs and outcomes. JAMA Cardiol. 2018;3(11):1041-9. https://doi.org/10.1001/jamacardio.2018.3029
13. Amin AH, Alqahtani F, Aljohani S, Farjo P, Patel K, Kawasra A, et al. The feasibility and safety of same-day discharge for all comers after elective percutaneous coronary interventions. Cardiovasc Revasc Med. 2020;21(5):588-91. https://doi.org/10.1016/j.carrev.2019.09.024
14. Bundhun PK, Soogund MZS, Huang W-Q. same day discharge versus overnight stay in the hospital following percutaneous coronary intervention in patients with stable coronary artery disease: a systematic review and meta-analysis of randomized controlled tri-als. PLoS One. 2017;12(1):e0169807. https://doi.org/10.1371/journal.pone.0169807
15. Conejo F, Ribeiro HB, Spadaro AG, Godinho RR, Faig SM, Gabrilaitis C, et al. Segurança e preditores de sucesso da alta hospitalar no mesmo dia após intervenção coronária percutânea eletiva. Rev Bras Cardiol Invasiva [Internet]. 2015;23(1):42-7. https://doi.org/10.1016/j.rbci.2015.01.001
16. Madan M, Bagai A, Overgaard CB, Fang J, Koh M, Cantor WJ, et al. Same-day discharge after elective percutaneous coronary interventions in Ontario, Canada. J Am Heart Assoc. 2019;8(13):e012131. https://doi.org/10.1161/JAHA.119.012131
17. Patel K, Banerjee S. Same-day discharge after elective uncomplicated percutaneous coronary interventions. J Am Heart Assoc. 2019;8:e013144. https://doi.org/10.1161/JAHA.119.013144
18. Jabara R, Gadesam R, Pendyala L, Chronos N, Crisco L V, King SB, et al. Ambulatory discharge after transradial coronary inter-vention: Preliminary US single-center experience (Same-day TransRadial Intervention and Discharge Evaluation, the STRIDE Stu-dy). Am Heart J. 2008;156(6):1141-6. https://doi.org/10.1016/j.ahj.2008.07.018
19. Small A, Klinke P, Della Siega A, Fretz E, Kinloch D, Mildenberger R, et al. Day procedure intervention is safe and complication free in higher risk patients undergoing transradial angioplasty and stenting. The discharge study. Catheter Cardiovasc Interv. 2007;70(7):907-12. https://doi.org/10.1002/ccd.21277
20. Biasco L, Pedrazzini GB, Araco M, Petracca F, Del Monte D, Sürder D, et al. Evaluation of a protocol for same-day discharge after radial lounge monitoring in a southern Swiss referral percutaneous coronary intervention centre. J Cardiovasc Med (Hagers-town). 2017;18(8):590-5. https://doi.org/10.2459/JCM.0000000000000519
21. Koshy SKG, George LK, Das P. Cost-effectiveness and outcomes with early or same-day discharge after elective percutaneous coronary intervention. Curr Cardiol Rep. 2020;22(6):42. https://doi.org/10.1007/s11886-020-01286-1
22. Rodriguez-Araujo G, Cilingiroglu M, Mego D, Hakeem A, Lendel V, Cawich I, et al. Same versus next day discharge after elective transradial PCI: The RAdial SAme Day DischArge after PCI trial. (The RASADDA-PCI trial). Cardiovasc Revasc Med. 2018;19(6S):7-11. https://doi.org/10.1016/j.carrev.2018.05.020
23. Lopez JJ, Ebinger JE, Allen S, Yildiz M, Henry TD. Adapting STEMI care for the COVID-19 pandemic: The case for low-risk STEMI triage and early discharge. Catheter Cardiovasc Interv. 2020;1:1-3. https://doi.org/10.1002/ccd.28993
24. Seto AH, Shroff A, Abu-Fadel M, Blankenship JC, Boudoulas KD, Cigarroa JE, et al. Length of stay following percutaneous coro-nary intervention: An expert consensus document update from the society for cardiovascular angiography and interventions. Ca-theter Cardiovasc Interv. 2018;92(4):717-31. https://doi.org/10.1002/ccd.27637
25. Borges Santos M. Same-day discharge after elective percutaneous transluminal coronary angioplasty: An instruction manual and call for increased uptake in a burdened National Health Service. Rev Port Cardiol. 2020;39(8):451-2. https://doi.org/10.1016/j.repc.2020.07.002
26. Mehran R, Rao S V, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011;123(23):2736-47. https://doi.org/10.1161/CIRCULATIONAHA.110.009449
27. Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, et al. Standardized end point definitions for coronary intervention trials: The Academic Research Consortium-2 Consensus Document. Eur Heart J. 2018;39(23):2192-207. https://doi.org/10.1093/eurheartj/ehy223
28. Bouleti C, Mewton N, Germain S. The no-reflow phenomenon: State of the art. Arch Cardiovasc Dis. 2015;108(12):661-74. https://doi.org/10.1016/j.acvd.2015.09.006
29. Barbeau GR, Arsenault F, Dugas L, Simard S, Larivière MM. Evaluation of the ulnopalmar arterial arches with pulse oximetry and plethysmography: comparison with the Allen's test in 1010 patients. Am Heart J. 2004;147(3):489-93. https://doi.org/10.1016/j.ahj.2003.10.038
30. Jirous S, Bernat I, Slezak D, Miklik R, Rokyta R. Post-procedural radial artery occlusion and patency detection using duplex ultra-sound vs. the reverse Barbeau test. Eur Heart J Suppl. 2020;22(Suppl F):F23-9. https://doi.org/10.1093/eurheartj/suaa095
31. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, Van Es G-A, et al. Clinical end points in coronary stent trials a case for standardized definitions. Circulation [Internet]. 2007;115:2344-51. https://doi.org/10.1161/CIRCULATIONAHA.106.685313
32. Cox LS, Sanchez-Borges M, Lockey RF. World Allergy Organization Systemic Allergic Reaction Grading System: Is a Modification Needed? J Allergy Clin Immunol Pract. 2017;5(1):58-62.e5. https://doi.org/10.1016/j.jaip.2016.11.009