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Mainly in Europe, Transradial percutaneous coronary intervention (TR-PCI) is rapidly becoming the gold standard especially in primary percutaneous coronary intervention (PCI). Its a very promising technique with a lot of benefits over the femoral approach. However, the exact effects of TRPCI on upper extremity function are unknown. Our aim is to investigate the prevalence, magnitude and mechanism of Upper Extremity Dysfunction (UED) post TRPCI.
This study is prospective observational cohort study were all patients, after baseline examinations, will be treated using the radial approach. Follow-up takes place after 24 hours, 2 weeks, 1 and 6 months. Upper extremity function consist of several parameters including anatomic integrity, strength, range of motion, coordination, sensory function and pain. Keeping these parameters in mind, a very sensitive binary score for UED is created as primary endpoint. This score is assessed after 2 weeks as compared to baseline, using validated examinations and questionnaires. Also, secondary endpoints including spasm, access-site bleeding and access-site hematoma were assessed.
Out of 314 patients evaluated at 2 weeks after they had undergone a TRPCI, 183(63.7%) had manifestations of UED on the access-side of the intervention (P<0.01 with non-intervention hand). At 6 months postprocedure this rate increased to 66.7%, with the main abnormalities being an increase in volumetry of the arm and hand and an decrease in extension strength of the elbow. Radial artery occlusion (RAO) at 2 weeks occurred in 26(8.3%) and was significantly associated with UED (p=0.036). At 6 months, 10 patients had a persistent RAO, whereas in 16 patients the radial artery recanalized. RAO at 6 months postprocedure was not associated with UED. After 6 months, 44 patients (14%) were referred to a hand rehabilitation specialist due to inhabilitation clinical complaints for further diagnostics and treatment.
Upper extremity dysfunction (UED) after transradial PCI does exist and persists up to 6 month. Up to 63,7% of patients reached primary endpoint of UED post TRPCI (P<0.01 with non-intervention hand). Furthermore, RAO at 2 weeks shows a significant relation with UED (p=0.036) whereas at 6 Months there is no significant relation with UED (p=0.607). Interestingly, 14% (n=44) of patients were referred to a handsurgeon and/or hand rehabilitation centre and could be equivalent to the clinical relevant % of UED. Clinical relevance of UED depends on profession and daily activities of the patients, an in depth analysis will be performed. Additionally, after complete enrollment (n=500) a multi-variate analysis and in depth analysis will be performed and are expected tol further unravel UED post radial PCI.