The RAVI registry: prospective, multicenter study of radial access in embolization procedures - 30 days follow up.
Journal
CVIR endovascular
ISSN: 2520-8934
Titre abrégé: CVIR Endovasc
Pays: Switzerland
ID NLM: 101738484
Informations de publication
Date de publication:
30 Jan 2024
30 Jan 2024
Historique:
received:
06
11
2023
accepted:
05
12
2023
medline:
30
1
2024
pubmed:
30
1
2024
entrez:
30
1
2024
Statut:
epublish
Résumé
There is a lack of registry studies about transradial access (TRA) outcomes. This prospective registry evaluated the TRA and procedure outcomes of visceral embolizations performed via TRA with 30-day follow-up. Prospective, multicenter registry included uterine fibroids (UFE), prostate artery (PAE), liver tumors (LT), and other hypervascular tumors (OHT) embolization performed in six US hospitals. Between February 2020 and January 2022, 99 patients underwent one radial artery visceral intervention (RAVI); 70 had UFE (70.7%), 16 PAE (16.2%), 7 LT (7.1%), and 6 OHT (6.1%). The mean age was 50.1 (±11.1) years, and 74/99 (74.7%) were females. The primary safety endpoints included hand ischemia, stroke, and death. Procedural success was defined as completing the intended procedure via radial artery (RA) access. Technical success was defined as the successful delivery of HydroPearl™ microspheres and complete embolization of the target vessel. Procedural and technical successes were 100% and 97%, respectively. There was no stroke, hand ischemia, radial-to-femoral conversion, access-related serious adverse events, or clinically evident radial artery occlusion at 30 days. There were two deaths: one respiratory failure and one progression of liver disease. Minor RA-related adverse event included arterial spasm, hematoma, and post-procedure discomfort. This prospective, multicenter, open-label registry confirmed the high safety profile and effectiveness of radial access in UFE, PAE, LT, and OHT embolization procedures without stroke, hand ischemia, or access-related serious adverse events at 30-day follow-up.
Sections du résumé
BACKGROUND
BACKGROUND
There is a lack of registry studies about transradial access (TRA) outcomes. This prospective registry evaluated the TRA and procedure outcomes of visceral embolizations performed via TRA with 30-day follow-up.
MATERIAL & METHODS
METHODS
Prospective, multicenter registry included uterine fibroids (UFE), prostate artery (PAE), liver tumors (LT), and other hypervascular tumors (OHT) embolization performed in six US hospitals. Between February 2020 and January 2022, 99 patients underwent one radial artery visceral intervention (RAVI); 70 had UFE (70.7%), 16 PAE (16.2%), 7 LT (7.1%), and 6 OHT (6.1%). The mean age was 50.1 (±11.1) years, and 74/99 (74.7%) were females. The primary safety endpoints included hand ischemia, stroke, and death. Procedural success was defined as completing the intended procedure via radial artery (RA) access. Technical success was defined as the successful delivery of HydroPearl™ microspheres and complete embolization of the target vessel.
RESULTS
RESULTS
Procedural and technical successes were 100% and 97%, respectively. There was no stroke, hand ischemia, radial-to-femoral conversion, access-related serious adverse events, or clinically evident radial artery occlusion at 30 days. There were two deaths: one respiratory failure and one progression of liver disease. Minor RA-related adverse event included arterial spasm, hematoma, and post-procedure discomfort.
CONCLUSION
CONCLUSIONS
This prospective, multicenter, open-label registry confirmed the high safety profile and effectiveness of radial access in UFE, PAE, LT, and OHT embolization procedures without stroke, hand ischemia, or access-related serious adverse events at 30-day follow-up.
Identifiants
pubmed: 38289433
doi: 10.1186/s42155-023-00415-5
pii: 10.1186/s42155-023-00415-5
doi:
Types de publication
Journal Article
Langues
eng
Pagination
15Subventions
Organisme : Terumo BCT
ID : TIS2019-02
Organisme : Terumo BCT
ID : TIS2019-02
Organisme : Terumo BCT
ID : TIS2019-02
Organisme : Terumo BCT
ID : TIS2019-02
Organisme : Terumo BCT
ID : TIS2019-02
Organisme : Terumo BCT
ID : TIS2019-02
Investigateurs
Andre Uflacker
(A)
Ricardo Yamada
(R)
Kirubahara Vaheesan
(K)
Ali Abdullah Malik
(AA)
Afsheen Sherwani
(A)
Clayton Commander
(C)
Maureen Kohi
(M)
Robert Lookstein
(R)
Francis Nowakowski
(F)
Rahul Patel
(R)
Rajesh Patel
(R)
Joseph Titano
(J)
Mona Ranade
(M)
Informations de copyright
© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.
Références
Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S, ESC Scientific Document Group. 2015 ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: task force for the Management of Acute Coronary Syndromes in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016;37(3):267–315. https://doi.org/10.1093/eurheartj/ehv320 . Epub 2015 Aug 29.
doi: 10.1093/eurheartj/ehv320
pubmed: 26320110
Members WC, Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao SV, Sellke FW, Sharma G, Yong CM, Zwischenberger BA. 2021 ACC/AHA/SCAI guideline for coronary artery revascularization: a report of the American College of Cardiology/American Heart Association joint committee on clinical practice guidelines. J Am Coll Cardiol. 2022;79(2):e21–e129. https://doi.org/10.1016/j.jacc.2021.09.006 . Epub 2021 Dec 9. Erratum in: J am Coll Cardiol 2022; 79(15):1547.
doi: 10.1016/j.jacc.2021.09.006
Posham R, Biederman DM, Patel RS, Kim E, Tabori NE, Nowakowski FS, Lookstein RA, Fischman AM. Transradial approach for noncoronary interventions: a single-center review of safety and feasibility in the first 1,500 cases. J Vasc Interv Radiol. 2016;27(2):159–66. https://doi.org/10.1016/j.jvir.2015.10.026 . Epub 2015 Dec 22. PMID: 26706186.
doi: 10.1016/j.jvir.2015.10.026
pubmed: 26706186
Kis B, Mills M, Hoffe SE. Hepatic radioembolization from transradial access: initial experience and comparison to transfemoral access. Diagn Interv Radiol. 2016;22(5):444–9. https://doi.org/10.5152/dir.2016.15571 . PMID: 27353460; PMCID: PMC5019848.
doi: 10.5152/dir.2016.15571
pubmed: 27353460
pmcid: 5019848
Bishay VL, Biederman DM, Ward TJ, van der Bom IM, Patel RS, Kim E, Nowakowski FS, Lookstein RA, Fischman AM. Transradial approach for hepatic Radioembolization: initial results and technique. AJR Am J Roentgenol. 2016;207(5):1112–21. https://doi.org/10.2214/AJR.15.15615 . PMID: 27767350.
doi: 10.2214/AJR.15.15615
pubmed: 27767350
Pryor W, Bourgeois A, Sanders K, Gilbert P, Egbert R, Yamada R, Guimaraes M. Radial access for liver-directed therapy: a single center prospective study. J Vasc Interv Radiol. 2016;27(3):S196.
doi: 10.1016/j.jvir.2015.12.506
Iezzi R, Pompili M, Posa A, Annicchiarico E, Garcovich M, Merlino B, Rodolfino E, Di Noia V, Basso M, Cassano A, Barone C, Gasbarrini A, Manfredi R, Colosimo C. Transradial versus Transfemoral access for hepatic chemoembolization: Intrapatient prospective single-center study. J Vasc Interv Radiol. 2017;28(9):1234–9.
doi: 10.1016/j.jvir.2017.06.022
pubmed: 28757286
Yamada R, Bracewell S, Bassaco B, Camacho J, Anderson MB, Conrad A, Lynn C, Burns P, Collins H, Guimaraes M. Transradial versus Transfemoral arterial access in liver Cancer embolization: randomized trial to assess patient satisfaction. J Vasc Interv Radiol. 2018;29(1):38–43. https://doi.org/10.1016/j.jvir.2017.08.024 . Epub 2017 Nov 15. PMID: 29150395.
doi: 10.1016/j.jvir.2017.08.024
pubmed: 29150395
Liu LB, Cedillo MA, Bishay V, Ranade M, Patel RS, Kim E, Nowakowski SF, Lookstein RA, Fischman AM. Patient experience and preference in Transradial versus Transfemoral access during Transarterial Radioembolization: a randomized single-center trial. J Vasc Interv Radiol. 2019;30(3):414–20. https://doi.org/10.1016/j.jvir.2018.10.005 . PMID: 30819485.
doi: 10.1016/j.jvir.2018.10.005
pubmed: 30819485
Bhatia S, Harward SH, Sinha VK, Narayanan G. Prostate artery embolization via Transradial or Transulnar versus Transfemoral arterial access: technical results. J Vasc Interv Radiol. 2017;28(6):898–905. https://doi.org/10.1016/j.jvir.2017.02.029 . Epub 2017 Apr 7. PMID: 28396191.
doi: 10.1016/j.jvir.2017.02.029
pubmed: 28396191
Nakhaei M, Mojtahedi A, Faintuch S, Sarwar A, Brook OR. Transradial and Transfemoral uterine fibroid embolization comparative study: technical and clinical outcomes. J Vasc Interv Radiol. 2020;31(1):123–9. https://doi.org/10.1016/j.jvir.2019.08.016 . Epub 2019 Nov 23. PMID: 31771890.
doi: 10.1016/j.jvir.2019.08.016
pubmed: 31771890
Adnan SM, Romagnoli AN, Martinson JR, Madurska MJ, Dubose JJ, Scalea TM, Morrison JJ. A comparison of Transradial and Transfemoral access for splenic Angio-embolisation in trauma: a single Centre experience. Eur J Vasc Endovasc Surg. 2020;59(3):472–9. https://doi.org/10.1016/j.ejvs.2019.11.028 . Epub 2019 Dec 18. PMID: 31865031.
doi: 10.1016/j.ejvs.2019.11.028
pubmed: 31865031
Iezzi R, Posa A, Bilhim T, Guimaraes M. Most common misconceptions about transradial approach in interventional radiology: results from an international survey. Diagn Interv Radiol. 2021;27(5):649–53. https://doi.org/10.5152/dir.2021.20256 . PMID: 34318753; PMCID: PMC8480943.
doi: 10.5152/dir.2021.20256
pubmed: 34318753
pmcid: 8480943
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.
doi: 10.1016/j.ahj.2003.10.038
pubmed: 14999199
Gayed A, Yamada R, Bhatia S, Fischman A, Heran MKS, Himes EA, Klass D, Patel S, Schiro BJ, Walker TG, Guimaraes M. Society of Interventional Radiology Quality Improvement Standards on radial artery access. J Vasc Interv Radiol. 2021;32(5):761.e1–761.e21. https://doi.org/10.1016/j.jvir.2020.12.013 . Erratum in: J Vasc Interv Radiol 2021; 32(7):1100. PMID: 33933252.
doi: 10.1016/j.jvir.2020.12.013
pubmed: 33933252
Pancholy S, Coppola J, Patel T, Roke-Thomas M. Prevention of radial artery occlusion-patent hemostasis evaluation trial (PROPHET study): a randomized comparison of traditional versus patency documented hemostasis after transradial catheterization. Catheter Cardiovasc Interv. 2008;72:335–40.
doi: 10.1002/ccd.21639
pubmed: 18726956
Mason PJ, Shah B, Tamis-Holland JE, Bittl JA, Cohen MG, Safirstein J, Drachman DE, Valle JA, Rhodes D, Gilchrist IC, American Heart Association Interventional Cardiovascular Care Committee of the Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Peripheral Vascular Disease; and Council on Genomic and Precision Medicine. An Update on Radial Artery Access and Best Practices for Transradial Coronary Angiography and Intervention in Acute Coronary Syndrome: A Scientific Statement From the American Heart Association. Circ Cardiovasc Interv. 2018;11(9):e000035. https://doi.org/10.1161/HCV.0000000000000035 . PubMed PMID: 30354598.
doi: 10.1161/HCV.0000000000000035
pubmed: 30354598
Rao SV, Tremmel JA, Gilchrist IC, Shah PB, Gulati R, Shroff AR, Crisco V, Woody W, Zoghbi G, Duffy PL, Sanghvi K, Krucoff MW, Pyne CT, Skelding KA, Patel T, Pancholy SB. Society for Cardiovascular Angiography and Intervention's Transradial working group. Best practices for transradial angiography and intervention: a consensus statement from the society for cardiovascular angiography and intervention's transradial working group. Catheter Cardiovasc Interv. 2014;83(2):228–36. https://doi.org/10.1002/ccd.25209 . Epub 2013 Oct 23. PubMed PMID: 24123781.
doi: 10.1002/ccd.25209
pubmed: 24123781
Khalilzadeh O, Baerlocher MO, Shyn PB, Connolly BL, Devane AM, Morris CS, Cohen AM, Midia M, Thornton RH, Gross K, Caplin DM, Aeron G, Misra S, Patel NH, Walker TG, Martinez-Salazar G, Silberzweig JE, Nikolic B. Proposal of a New Adverse Event Classification by the Society of Interventional Radiology Standards of Practice Committee. J Vasc Interv Radiol. 2017;28(10):1432–1437.e3. https://doi.org/10.1016/j.jvir.2017.06.019 . Epub 2017 Jul 27. Erratum in: J Vasc Interv Radiol 2018; 29(1):146. PMID: 28757285.
doi: 10.1016/j.jvir.2017.06.019
pubmed: 28757285
Sengoba KS, Ghant MS, Okeigwe I, Mendoza G, Marsh EE. Racial/ethnic differences in Women's experiences with symptomatic uterine fibroids: a qualitative assessment. J Racial Ethn Health Disparities. 2017;4(2):178–83. https://doi.org/10.1007/s40615-016-0216-1 . Epub 2016 Apr 11. PMID: 27068661; PMCID: PMC5064808.
doi: 10.1007/s40615-016-0216-1
pubmed: 27068661