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Impact of Radial Arterial Sheath Size on RAO E Abdelaal, MD MRCP CCT Interventional Fellow University of Laval, Quebec Heart and Lung Institute Fellows’ Meeting- Wed Jan 18th 2012Article: Uhlemann M, et al JACC Cardiovasc Interv. 2012 Jan;5(1):36-43.Editorial: Observations from a transradial registry our remedies oft in ourselves do lie. Rao SV. JACC Cardiovasc Interv. 2012 Jan;5(1):44-6
Background• Radial epidemic• First diagnostic by L. Campeau 1989, 1st intervention Kiemeneij 1993• TRA popularity as superior safety compared to femoral access: • Lower rate of access site complications • Shorter hospital stay • Improved patient comfort • Lower mortality in STEMI • Less bleeding (predictor of morbidity and mortality) • RIVAL data- (Radial vs. Femoral in ACS) • Radial reduces major vascular complications • Mortality reduction in favour of radial in STEMI
However• 2 main concerns with TRA remain: • Post procedural RAO- multiple predictors • Radiation: dependent on operator’s experience• RAO: • Ranges form 5-38 % depending on study • Large variation reﬂects lack of consensus on how and when to assess for RAO
Study Objectives• Primary: • To investigate impact of radial sheath size on rate of RAO after diagnostic catheterization and PCI using 5 and 6-F sheaths• Secondary: • To assess other access site complications (Pseudoaneurysm, AVF, haemorrhage) after TRA Uhlemann M et al.JACC Cardiovasc Interv. 2012 Jan;5(1):36-43.
Methods-1• Prospective study of 455 consecutive patients undergoing trans-radial diagnostic angiography and PCI Nov 2009- Aug 2010• Doppler USS obtained in all patients• Vascular risk factors (DM, HTn, dyslipidemia, smoking)• Presence of CAD, PAOD, Cerebrovascular disease• Allen test not routinely performed as lack of consensus* Uhlemann M et al.JACC Cardiovasc Interv. 2012 Jan;5(1):36-43.* Jarvis MA et al. Reliability of Allen’s test in selection of pateints for radial artery harvest. Ann Thorac Surg 2000;70:1362-5
Methods-2• Sheaths: All hydrophilic coated, 7-cm length: • 6-Fr (RAIOFOCUS introducer ,Terumo medical, Leuven, Belgium) • Used in 302 patients with higher risk ACS and adhoc PCI • Outer diameter 2.10 mm • 5-Fr (Engage TR introducer, SJM TM) • used in 153 patients • Outer diameter 1.92mm• RRA in 442 (97.1%), and LRA in 13 (2.9%)• Anticoagulant: 2,500 IU UFH for diagnostic, and 100 IU/kg for PCI• IA 200 mcg Nitrate. IA verapamil only for spasm
Methods-3• Haemostasis: • Sheath removal immediately at the end of procedure • TR band was applied with occlusive compression, slow removal of air until bleeding occurred, then re-insufﬂation of 1-2 ml of air • Or • RadiStop: applied with palpation of radial pulse distal to compression site, and loosened if absent pulse until palpable or bleeding occurred• Vascular USS: • Colour Doppler USS performed by experienced sonographers within 1+/- 1.3 days after procedure • Vivid 7, 9-12 MHz multifrequency vascular probe
Methods-4• Endpoints: • Primary: incidence of Post-procedural RAO as conﬁrmed by absence of antegrade ﬂow on vascular ultrasound • Secondary: other access site complications • Bleeding- GUSTO deﬁnition (mild, moderate, severe)• FU: • Symptomatic patients with RAO treated with LMWH for 7-14 days • Asysmptomatic: no speciﬁc therapy • 2nd FU 7-14 days post procedure if RAO detected
Results: Flow chartUhlemann M et al.JACC Cardiovasc Interv. 2012 Jan;5(1):36-43.
Results: baseline characteristicsUhlemann M et al.JACC Cardiovasc Interv. 2012 Jan;5(1):36-43.
Procedural data: 389 (85.5%) underwent diagnostic procedures 66 underwent PCI (14.5%) Amount of contrast signiﬁcantly different between 5 and 6-Fr groups No difference in ﬂuoroscopic timeVascular complication rates: RAO: 30.5% in 6-Fr vs. 13.7% in 5-Fr In 22 patients with ultrasonic signs of RAO, pulse was still palpable Local complications: 33% in 6-Fr vs. 14.4% in 5-Fr 3 Pseudoaneurysm, 1 requiring surgical repair Uhlemann M et al.JACC Cardiovasc Interv. 2012 Jan;5(1):36-43.
Predictors of RAO in current study• With univariate analysis: • female sex, • younger age, • the presence of POAD • cerebrovascular diseaseUhlemann M et al.JACC Cardiovasc Interv. 2012 Jan;5(1):36-43.
Predictors of RAO: Multivariate regression analysis Variable OR 95% CI P-value Female gender 2.36 1.5-3.73 <0.001 Age 0.96 per yr 0.94-0.98 0.001 6-Fr 2.68 1.56-4.59 <0.001 PAOD 2.04 1.02-4.22 0.04Uhlemann M et al.JACC Cardiovasc Interv. 2012 Jan;5(1):36-43.
Subgroup analysis: diagnostic only• Same predictors with 6-Fr in diagnostic angiography, except cerebrovascular disease• Multivariate: unchanged• PCI did not inﬂuence vascular complications• BMI associated with a higher occurrence of RAO (p=0.335)Uhlemann M et al.JACC Cardiovasc Interv. 2012 Jan;5(1):36-43.
Clinical course of RAO• Total RAO= 113 patients • 48 (42.5%) became symptomatic within 24 hrs after procedure • 8 patients (7.1%) became symptomatic within 4.1 +/- 2.1 days upon resuming physical activity• Symptoms: • Painful forearm and thenar eminence • Loss of hand grip & parasthesia • No critical limb ischaemia Uhlemann M et al.JACC Cardiovasc Interv. 2012 Jan;5(1):36-43.
FU of RAO• 22 lost for FU!• 54 symptomatic patients treated with LMWH • wt-adjusted n=17, or 1/2 Rx dose if DAPT n=37• Recanalization at ﬁrst FU: • 17/54 (31.5%) after LMWH vs. • 2/37 (13.5%) in patients without anticoagulation• Second FU for persistent RAO 14 days post procedure: • ﬁnal recanalization rate • 55.6% (30/54) in LMWH vs. • 13.5% (5/37) with no anticoagulationUhlemann M et al.JACC Cardiovasc Interv. 2012 Jan;5(1):36-43.
Discussion• Clinical assessment alone might miss RAO and underestimate its true incidence• Present registry shows 5-Fr sheaths reduce rate of RAO by as much as 55%• Routine radial USS after TRA: • Signiﬁcantly higher complication rate than expected from previous studies Uhlemann M et al.JACC Cardiovasc Interv. 2012 Jan;5(1):36-43.
Limitations• Acknowledged by authors: • Design: registry & not randomized- selection bias could not be ruled out • No USS measurement of radial diameter pre procedure • Non-standardized FU intervals when RAO was diagnosed • Single centre with limited number of patients Uhlemann M et al.JACC Cardiovasc Interv. 2012 Jan;5(1):36-43.
Discussion- Editorial• Sheath size: • Relationship between sheath size and RAO has been shown in randomized trials & current study conﬁrms this Dahm JB et al. A randomized trial of 5 vs. 6 French transraidal percutaneous coronary interventions. Catheter Cardiovasc Interv 2002;57:172-6 • However, rate of RAO reported here is substantially higher than what has been shown in other studies Sanmartin M et al. Interruption of blood ﬂow during compression and radial artery occlusion after transradial catheterization. Catheter Cardiovasc Interv 2007;70:185-9• Anticoagulation: Plante S et al. Comparison of bivalirudin versus heparin on radial artery occlusion after transradial cathetetrization . Catheter Cardiovasc Interv 2010;76:654-8 • 85 % of pts. received only 2,500 IU UFH ( with a BMI >25), therefore signiﬁcant under-dosing• Patent hemostasis: • Current study does not report duration of radial compression, and no conﬁrmation of patent haemostasis Pancholy S et al Prvention of radial artery occlusion-patent hemostasis evaluation trial (PROPHET study): a randomized comparison of traditional vs patency-documented hemostasisafter TRA. Cather Cardiovasc Interv 2008;72:335-40 • Cubero JM et al. Radial compression guided by mean artery pressure vs standard compression with a pneumatic device (RACOMAP). Catheter Cardiovasc Interv 2009;73:467-72
Rao SV. Observations from a transradial registry our remedies oft in ourselves do lie. Cardiovasc Interv. 2012 Jan;5(1):44-6
Discussion• Symptoms: • What are the symptoms of RAO? • ? Symptoms due to RAO? • Reported here likely to have been due to radial artery thrombosis and overlying inﬂammation (arteritis) Staniloae CS et al. Histopathologic changes of the radial artery wall secondary to tranradial catheterization.Vasc Health Risk Manag 2009;5:527-32• LMWH for RAO: • Has also been previously described. • No control group, hyposthesis-generating • Ipsilateral ulnar compression shown to increase rate of recanalization (? more effective than LMWH) Zankl et al. Radial artery thrombosis following transradial coronary angiography: incidence and rationale for treatment of symptomatic patients with LMWH. Clin Res Cardiol 2010;99:841-7 • Bernat I, Bertrand OF et al. Efﬁcacy and safety of transient ulnar artery compression to recanalize acute radial artery occlusion after transradial catheterization. Am J Cardiol 2011;107:1698-701
Take home message• Despite its superior safety, cost-effectiveness and potential mortality beneﬁt compared to femoral, radial approach is not without limitations• RAO should be recognized as an adverse consequence and avoided by adopting proven strategies: • Adequate anticoagulation • Respect outer sheath: inner arterial diameter ratio (<1) esp in females! • Patent haemostasis and limited duration of compression