07 technical Staehli aimradial20170922 Catheters
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Single versus dual catheters for transradial approach - Barbara Staehli
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07 technical Staehli aimradial20170922 Catheters
- 1. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Single versus Dual Catheter for Transradial Coronary Angiography PD Dr. med. Barbara E. Stähli, MD, MBA Medizinische Klinik für Kardiologie Charité – Universitätsmedizin Berlin, Campus Benjamin Franklin
- 2. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Disclosures • None
- 3. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Outline • Background: transradial coronary angiography two catheter concepts one catheter concepts • UDDC Radial (Use of Different Diagnostic Catheters in transradial coronary angiography) Trial • Conclusion
- 4. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Transradial artery approach The transradial artery approach (TRA) has become the preferred strategy for coronary angiography and percutaneous coronary intervention (PCI) in daily clinical routine. Metaanalysis femoral vs. radial access: Ferrante G, et al. J Am Coll Cardiol Intv 2016;9:1419-34
- 5. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Two catheter concepts (TCC)
- 6. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Special one catheter concepts (OCC), allowing for an intubation of both coronary ostia, were developed to avoid catheter exchange during coronary angiography. BLK (Terumo, Somerset, New Jersey, USA) Tiger II (Terumo, Somerset, New Jersey, USA) Prevention of - Unnecessary mechanical irritation - Vessel injury - May save costs and procedure time One catheter concepts (OCC)
- 7. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Optimal catheter selection ?
- 8. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Comparison between OCC and TCC Kim SM, et al. Int J Cardiovasc Imaging 2006;22:295-303 n=160
- 9. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Comparison between OCC and TCC Chen O, et al. Am J Cardiol 2016;118:357-361 n=110
- 10. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Comparison between OCC and TCC Chen O, et al. Am J Cardiol 2016;118:357-361 Cross-over from the Tiger catheter arm to the standard Judkins catheter arm was observed in 8 patients (14%), mainly due to substandard image quality and difficulty in coronary engagement.
- 11. U N I V E R S I T Ä T S M E D I Z I N B E R L I N UDDC Radial: Aim of the study • Despite the routine use of OCC in clinical practice, their clinical performance and efficacy for TRA have never been sufficiently evaluated in prospective studies. • The study was designed to assess the safety and efficacy of a OCC using BLK or Tiger II catheters in comparison to a two catheter concept (TCC) using standard Judkins catheters. • The UDDC-Radial (Use of different diagnostic catheters over the radial access) Trial.
- 12. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Methods – Inclusion Criteria • Prospective, randomized, patient-blinded, single-center study • Procedures were performed by 12 operators (all familiar with TRA) after a run-in phase (BLK and Tiger II training during clinical routine) • Inclusion criteria: • Guideline-based indication for coronary angiography. • Exclusion criteria: • Acute coronary syndrome or cardiogenic shock. • Coronary bypass graft angiography. • Renal failure (estimated glomerular filtration rate <60 ml/min/1.73 m2). • Contraindications for transradial access.
- 13. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Methods – Trial Design One catheter concept (OCC) BLK (n=100) Tiger II (n=100) Randomization Patients with indication for coronary angiography (n=300) Two catheter concept (TCC) Judkins (n=100) Study specification: Complete coronary angiogram including 6 different projections for the left coronary artery and 3 for the right coronary artery
- 14. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Methods – Endpoints Primary endpoint: Total coronary angiography time (sec) for a complete diagnostic coronary angiogram using OCC vs. TCC (assessed by “intention-to-treat analysis”) Secondary endpoints: • Conversion to other catheters or to transfemoral access • Amount of contrast volume (ml) • Fluoroscopy time (min) • Peri-procedural complications (radial artery spasm, dissection, catheter kinking) • Ostial stability of the catheter
- 15. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Two catheter concept (TCC; n=100) One catheter concept (OCC; n=200) Age, years (IQR) 73.5 (62.2-78.7) 70.8 (60.5-77.5) 0.18 Male gender, (%) 53% (53/100) 67% (134/200) 0.02 Body mass index, kg/m2 (IQR) 26.5 (24.4-31.1) 27.3 (24.6-30.8) 0.45 Height, cm (IQR) 170 (165-179) 175 (168-180) 0.02 Cardiovascular risk factors, (%) Arterial hypertension 76% (76/100) 84% (168/200) 0.15 Hyperlipidemia 61% (61/100) 64% (128/200) 0.16 Type 2 diabetes 29% (29/100) 18% (35/200) 0.02 Current smoking 18% (18/100) 17% (34/200) 0.93 Glomerular filtration rate, ml/min/1.73 m2 (IQR) 78.0 (62.0-89.0) 76.0 (61.0-89.0) 0.72 Baseline characteristics
- 16. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Primary endpoint: No significant difference in angiography time between OCC and TCC TCC 552 ± 26 sec OCC 603 ± 29 sec
- 17. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Significantly increased cross-over rates for OCC
- 18. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Cross-over assessment Cross-over to other TRA systems Reason for failure BLK (n=38) Tiger II (n=35) p value Visualization of the left coronary system not possible 63% (24/38) 89% (31/35) 0.03 Visualization of the right coronary system not possible 37% (14/38) 11% (4/35) 0.01 Cross-over rates were mainly due to ostial catheter instability and suboptimal engagement/visualization of the left coronary artery system.
- 19. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Angiography time (per protocol) p<0.001Judkins 481± 189 s BLK / Tiger II 344 ± 133 s
- 20. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Significantly longer fluoroscopy time for OCC TCC 258 ± 28 sec OCC 408 ± 37 sec
- 21. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Significantly higher amount of contrast volume for OCC TCC 67 ± 4 ml OCC 98 ± 5 ml
- 22. U N I V E R S I T Ä T S M E D I Z I N B E R L I N No safety concerns Two catheter concept (TCC; n=100) One catheter concept (OCC; n=200) p value Radial artery spasm 2% (2/100) 1% (2/200) 0.48 Dissection 0% (0/100) 0% (0/200) - Catheter kinking 0% (0/100) 0% (0/200) - High safety profile without any differences between groups
- 23. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Summary The UDDC-Radial Trial was the first sufficiently powered, prospective, randomized trial designed to assess the role of OCC vs. TCC for transradial coronary angiography: • The use of OCC did not translate into shorter angiography time as compared to standard TCC for TRA, mainly due to an increased cross-over rate after OCC failure. • OCC were associated with a higher amount of contrast volume and extended fluoroscopy time as compared to TCC, independent of the catheter system (Tiger II or BLK). • Hence, further optimization of OCC designed for TRA is needed. A TCC using standard Judkins catheters remains a reliable option for TRA.
- 24. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Summary “No points are earned for coronary catheterization – the catheters know where to go if not thwarted by the operator” Judkins MP. Radiology 1967;89:815
- 25. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Thanks to: David M. Leistner Ulf Landmesser Vera Schneider Carsten Skurk Alexander Lauten Christian Mochmann Patrick Schauerte Ursula Rauch-Kröhnert Mathias Riedel Georg Fröhlich
- 26. U N I V E R S I T Ä T S M E D I Z I N B E R L I N Thank you for your attention! PD Dr. med. Barbara E. Stähli, MD, MBA Medizinische Klinik für Kardiologie Charité – Universitätsmedizin Berlin, Campus Benjamin Franklin
Editor's Notes
- Mr Chairmen, dear colleagues, ladies and gentelemen Thank you very much for the invitation. 2) It’s my great pleasure to speak about single versus dual catheter concepts for TRA und to present our data. 3) Although it’s a very interesting and important question which really impacts on everyday clinical practice, this topic has rarely been addressed in clinical studies, and I am looking forward to discussing it with you.
- No disclosures.
- This slide gives you a brief overview of my talk I would like to first outline the current literature, in particular the comparsion between one and tow catheter concepts for transradial coronary angiography. Just to get into the topic. Then, I would like to share with you our data, and present the design and results of the UDDC Radial Trial, which was performed at our institution And finally, I have a summary and conclusion slide to put everything together
- TRA has become the preferred strategy for coronary angiography and PCI given its proven safety and efficacy. 2) Just briefly illustrated on this slide by a recently published meta-analysis -1) wich included over 22’000 patients to compare transfemoral versus transradial coronary angiography. -2) benefits of the transradial approach were observed for major bleeding and vascular complications and also rates of mortality and MACE. They are all on the left hand side of the 1.0-Line. 3) You all know the study data, which translated into a class IA recommendation for TRA in current guidelines effects of the radial access were consistent across the whole spectrum of patients with CAD for all appraised endpoints. Efféct Càtheter 30% reduction in mortality 15% reduction in MACE 50% major bleeding 80% major vascular complications
- In principle, there are 2 different catheter concepts for transradial coronary angiography: a two catheter concept and a one catheter concept In the late 60ies, Dr Melvin Judkins designed one of the most frequently used catheters, the Judkins Left and Right catheters shaped to engage the respective coronary ostium.
- The widespread popularity of the transradial access/different anatomical characteristics and challenges in TRA have fueled the search for novel catheter designs. And dedicated radial artery catheters were developed, specifically designed to engage both coronary ostia with one single catheter, thereby avoiding catheter exchange during coronary angiography. 2) Amon them are the Tiger II and the BLK catheter. 3) One catheter concepts are considered to prevent unnecessary mechanical irritation and vessel injury and may save costs and procedure time This means that a catheter exchange is required for completion of coronary angiography. While using the transradial route, the more catheter exchanges, the more likely it is to get radial artery spasm. BLK: Brachial Type Katheter
- But we have «the agony of choice» regarding the optimal catheter selection And there is paucity of data supporting one over the other
- In a prospective Korean Study , a total of 160 patients were randomized to either Tiger or Judkins catheters. And you see that the Tiger catheter was associated with a significantly shorter fluoroscopy time (30%) and a shorter procedure time (40%) for diagnostic coronary angiography as compared with the Judins catheter. 160 Patients, 2003 and 2004 The Tiger II provided superior right coronary angiograms, compared with the Judkins catheter (2.99± 0.11 vs. 2.82±0.48, p=0.003). No quality difference for the left system. For the left coronary angiograms, the initial randomized catheter completed the procedure in 91% of the patients with the Tiger II and in 98% with the Judkins (p=0.167) catheters. For the right coronary angiograms, 100% were completed with the Tiger II and 95% with the Judkins (p=0.120) catheters. Procedure Time: time spent from the initial catheter insertion into the radial sheath to the last catheter withdrawal from the sheath
- Similar results or trends were observed in a second, smaller study which randomized at total of 110 patients to either Tiger or Judkins catheters. The end points included fluoroscopy time, total procedure time, dose-area product, and amount of contrast volume used. And as you can see, the Tiger catheter was associated with a significantly reduced fluoroscopy time, and trends in favor of the Tiger catheter were observed for the other endpoints. 2015
- However, in this study, a total of 8 patients (14%) were crossed over..... ..and this cross-over rate was not taken into account, when comparing catheter concepts.
- Given these limitations/and the paucity of data in this field, we designed the UDDC Radial Trial to assess the safety and efficacy of ….
- It was a …. All procedures were performed by experienced oberators, familiar with TRA and both catheter designs Which were the inclusion and exclusion criteria? - all patiens with a guideline-based indication for coronary angiography were included - exclusion criteria comprised ACS or cardiogenic shock, bypass graft angiography, renal failure, and contraindication for TRA
- Based on the power calculation, a total of 300 patients were randomized to either a TCC using the Judkins catheters or a OCC using the BLK or Tiger Complete coronary angiography was defined as an angiogram with 6 different projections for the left coronary artery and 3 for the right.
- The primary endpoint was the time required to perform a coronary angiography with standardized projections using either the OCC or the TCC And in contrast to the previously mentioned studies, the endpoint was assessed by a «intention-to-treat analysis», meaning that the total coronary angiography time was measured starting with the randomized catheter, but also including potential catheter exchanges Secondary endpoints comprised conversion, amount, fluoroscopy time, rates of peripropedural complications, ostial stability of the catheter
- Now let me present the results. This slide summarizes the baseline characteristics of our patients. Median age was around 70 years with 60% being male. And you see the rather high prevalence of cardiovascular risk factors, usually encountered in this patient population.
- There was no significant difference in angiography time between the one and the two catheter concept. There were trends observed in favor of the Judkins catheter but without, however, reaching statistical significance. There was also no difference between the BLK and the Tiger catheter.
- 1) Now, when we have a look at the cross-over rates of the TCC and the OCC. The cross-over rates of the BLK and Tiger catheters were significantly higher as compared to the standard Judkins catheters - With the Judkins catheter, 4% of patients were crossed-over to another catheter, and corresponding rates were 38 and 35% in the BLK and the Tiger groups - Cross-over to the femoral access was needed in 8% with the Judkins catheter, and in 8 and 4% with the BLK and Tiger II catheter 2) And this increased need for cross-over in the OCC group accounted for a substantial proportion of the total angiography time.
- Cross-over rates…. When comparing BLK and Tiger catheters, suboptimal visualization of the left coronary system was more frequently observed with the Tiger catheter, whereas failure to visualize the right coronary artery was more often in the BLK group.
- 1) When we have a look at the per protocol analysis, we see that switching with the BLK or Tiger from the left to the right is faster than a catheter exchange with the Judkins catheters, resulting in a shorter procedure time.
- Fluoroscopy time was significantly longer with a OCC as compared to a TCC Again without any difference between BLK and Tiger.
- The amount of contrast volume was significantly higher in the OCC as compared to TCC. No differences between BLK and Tiger.
- As expected, no saftey concerns were observed. Radial artery spasm occurred in 2 patients in each group. High safety profile without any differences between groups.
- To wrap up: - These findings underline the need to further advance catheter desings.
- and let me end with Melvin Judkins saying: «swarded»
- Thanks to the whole team and