08 aimradial2016 fri S IJsselmuiden
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This study investigates the prevalence and causes of upper extremity dysfunction (UED) after transradial percutaneous coronary intervention (TRPCI). Preliminary results found that 63% of patients experienced UED up to 6 months post-procedure. At 2 weeks, positive family history of coronary artery disease and radial artery occlusion were associated with UED. By 6 months, reduced wrist flexion and increased symptom scores were drivers of UED. Approximately 11% of patients were referred for hand specialist care. The study aims to further analyze causes of long-term UED after TRPCI.
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08 aimradial2016 fri S IJsselmuiden
- 1. Unraveling Upper Extremity function after transradial PCI preliminary results On behalf of the ARCUS Investigators Dr. AJJ IJsselmuiden MD PhD
- 2. Potential Conflicts of Interest I do not have any potential conflict of interest Dr. AJJ IJsselmuiden MD PhD
- 3. ARCUS Study • Transradial PCI (TRPCI) is gaining popularity • Very promising technique: • Lower major bleeding and mortality in STEMI • Fewer access-site complications • Shorter Hospital stays • Lower costs • Exact effects of TRPCI on upper extremity function are unknown • Multicentre prospective observational study • Aim: to investigate the prevalence, magnitude and mechanism of Upper Extremity Dysfunction (UED) post TRPCI 5/10/16 A.J.J.IJsselmuiden Upper Extremity Function
- 4. Methods • Target N = 500 • Measurements • Echo doppler : Radial artery occlusion? • Questionnaires: VAS, DASH, BCTQ • Volumetry Hand & Forearm • Sensibility fingertips • Key & Palmar grip • Isometric strength wrist & elbow • Both upper extremities • Measurements at baseline, 24 hr, 2 wks, 1 mo. & 6 mo
- 5. Primary endpoint 5/10/16 A.J.J.IJsselmuiden Compiled binary score for UED at 2 weeks vs. baseline (Validated by Hand surgeons)* *Prof Ritt ( Dept. Handsurgery, VUMC, Amsterdam), Dr Holtzer (Dept. Handsurgery, ASZ, Dordrecht)
- 6. Radial procedure • ± 0,5 cc Lidocaine 2% • Access method: (Modified) Seldinger • Radial cocktail; verapamil 5mg + nitroglycerin 200 ug + 10 ml saline • Terumo 6F Sheath • 6 Fr Hydrophilic Guiding Catheter (Pendracare) • Hemostasis; pressure wrist strap: 13 cc air • Sling • TR band maximum 4 hours • Patient home with 4cc, next morning removal • In case of swelling arm a non-elastic pressure compress 5/10/16 Naam persoon
- 7. INTERIM RESULTS I 5/10/16 A.J.J. IJsselmuiden During analyses 66,4% completed the 6 months FUP Patient Characteristics All patients No.(%) N= 211 Upper extremity dysfunction No.(%) N= 123 No Upper extremity dysfunction No.(%) N=65 p-value Gender (male) 159(81.5%) 98 (79.7%) 54 (83.1%) 0.45 Mean Age ± SD (years) 64.9±10.3 63.7 ± 10.5 66.8 ± 9.4 0.07 Mean BMI ± SD 27.8±5.1 27.9 ± 4.9 27.5 ± 5.2 0.62 Mean Height ± SD (cm) 176.2±8.7 176.1 ± 9.1 180.8 ± 39.7 0.22 Smoking Active Smoker Stopped No 33 (17.1%) 96(45.5%) 64(33.2%) 22 (17.9%) 55 (44.7 %) 45 (36.6%) 10 (15.4%) 37 (56.9%) 17 (26.2%) 0.68 0.10 0.15 Hypertension 104(53.6%) 64 (52.0%) 37 (56.9%) 0.53 Dyslipidemia 64(33.0%) 37 (30.1%) 25 (38.5%) 0.23 Diabetes Mellitus 36(17.1%) 19 (15.4%) 16 (24.6%) 0.14 Positive family history cardiac heart disease 83 (39.3%) 62 (50.4%) 17 (26.2%) 0.002* Pre-existent Hand disease intervention hand 82(38.9%) 51 (41.5%) 29 (44.6%) 0.68 Previous TR-PCI 64(32.8%) 39 (31.7%) 23 (35.4%) 0.76 Previous TR-procedures 111(56.9%) 70 (56.9%) 37 (56.9%) 0.98
- 8. INTERIM RESULTS II 5/10/16 A.J.J. IJsselmuiden Complications 2 weeks No.(%) N=188 6 months No.(%) N=126 p-value Minor Access-site bleeding 1 (0.5%) 0 (0%) ns Radial artery occlusion 14 (7.4%) * 6(3.1%) 0.93 Access-site Hematoma Major (>5cm) Minor (<5cm) 13 (6.9%) 17(9.0%) 0 (0%) 0 (0%) 0.000 Swelling (inspection) 5 (2.6%) 2 (1.5%) 1.00 Perforation/ dissection 0 (0.0%) 0 (0%) 1.00 Upper extremity dysfunction 123 (65.4%) 80 (63.0%) 1.00 * p<0.001 UED (N=12 (9.8%)) vs non-UED (N=2 (3.1%)) RAO: some recanalize, some arise with a late onset (re-PCI, arterial line, spontaneous)
- 9. Upper extremity dysfunction (UED) • UED Intervention Hand: 65,4 % at 2 weeks vs 63% at 6 months (P<0.001 compared to non-intervention hand) • Impaired variables causing UED in intervention hand % 0 5 10 15 20 25 30 35 40 RAO Pain Palmar grip Flex elbow Key grip FS score Ext elbow Ext wrist DASH Sensibility Volumetry Arm Flex wrist SS score Volumetry Hand 2 weeks 6 months * **P<0.05 *
- 10. Upper extremity dysfunction (UED) Major drivers at 2 weeks: 34% DASH↑ 27% sensibility ↓ 30% volumetry hand↑ % 0 5 10 15 20 25 30 35 40 RAO Pain Palmar grip Flex elbow Key grip FS score Ext elbow Ext wrist DASH Sensibility Volumetry Arm Flex wrist SS score Volumetry Hand 2 weeks 6 months * **P<0.05 *
- 11. Upper extremity dysfunction (UED) Major drivers at 6 month: 30% wrist flexion ↓ 32% SS ↑ 35% volumetry hand↑ % 0 5 10 15 20 25 30 35 40 RAO Pain Palmar grip Flex elbow Key grip FS score Ext elbow Ext wrist DASH Sensibility Volumetry Arm Flex wrist SS score Volumetry Hand 2 weeks 6 months * **P<0.05 *
- 12. Upper extremity dysfunction (UED) Comparison drivers UED 2 weeks vs 6 month % 0 5 10 15 20 25 30 35 40 RAO Pain Palmar grip Flex elbow Key grip FS score Ext elbow Ext wrist DASH Sensibility Volumetry Arm Flex wrist SS score Volumetry Hand 2 weeks 6 months * **P<0.05 *
- 13. Clinical Relevance (all 10.9%) 2 weeks 1 month 6 months Referral 9 (4.7%) 8 (4.1%) 6 (3,1%) Total points 7.0±3.0 4.1±3.6 6.8±2.7 Gender (male) 6 (66.7%) 8 (100%) 4 (66.7%) Height (cm) 170.2±10.8 183.8±7.2 172.6±10.5 BMI 28.8±4.2 28.2±4.0 27.2±2.7 Age 61.1±11.8 58.7±7.1 61.8±4.9 Hypertension 4(44.4%) 4(50.0%) 5 (83.3%) Dyslipidemia 4(44.4%) 4(50.0%) 2(33.3%) Diabetes 1(11.1%) 1(12.5%) 1(16.7%) Smoking No Yes Previous 6(66.7%) 2(22.2%) 1(11.1%) 2(25.0%) 2(25.0%) 4(50.0%) 2(33.3%) 2(33.3%) 2(33.3%) Positive family history 6(66.7%) 3(37.5%) 4(66.7%) Preexistent hand disease 4(44.4%) 4(50.0%) 1(16.7%) 5/10/16 A.J.J.Ijsselmuiden
- 14. CONCLUSIONS • Upper extremity dysfunction (UED) after transradial PCI does exist and persists upto 6 month • 63% of patients reached primary endpoint UED post TRPCI upto 6 month (P<0.001 non-intervention hand) • 10.9% of patients were referred to a handsurgeon and/or hand rehabilitation center (+/- 7 points primary endpoint) • Positive family history of coronary artery disease shows a significant relation with UED (P<0.001) • At 2 weeks radial artery occlusion shows a significant relation with UED (9.8% v.s 3.1%; P<0.001) • Significant increase at 6 month in % of patients with a diminished key and palmar grip and more severe symptom score 5/10/16 A.J.J. IJsselmuiden
- 15. DISCUSSION • Clinical relevance of UED depends on profession and daily activities patients • Primary endpoint probably too sensitive for detecting UED and will be re- evaluated by handexperts • 10.9% of patients were referred to handexperts and could be equivalent to the clinical relevant % of UED • Complete enrollment (n=500), Multi-variate analysis and in depth analysis are currently performed and will further unravel UED post radial PCI • Currently a femoral control group is being enrolled 5/10/16 A.J.J. IJsselmuiden
- 16. SOLVE Upper Extremity Dysfunction Prevention: • Slender techniques: Sheathless/ 4-5F catheter Miniturization PCI equipment e.g. stent on the wire (Svelte) • Closure technique: partial radial occlusion evaluated by oximetry Treatment: • Early referral • Treatment hand rehabilitation center/ surgery • OPERA trial (OCT radial artery) 5/10/16 A.J.J. IJsselmuiden
Editor's Notes
- Upper extremity function consist of several important physiologic parameters strength…anatomic integrity. Pain negatively affects all parameters
- Keeping all those physiological parameters which form upper extremity fynction in mind we designed our studymethod. Our target number of patients is 500. Measurements consist of We did Echo doppler; to assess vessel anomalies and radial artery occlusion we used Questionnaires: to assess pain, disabilities of the arm, hand and shoulder en carpal tunnel syndrome Volumetry of the hand and forearm, to assess swelling Sensbility assessment of the fingertips And strength measurments to assess the key and palmar grip and isometric strength of the wrist and elbow. Both upper extremities will be examined Measurements will take place at baseline, 24h, 2 weeks, 1 month and six months.
- Symptom-severity score 8 en BCTQ 11 Dash >15% 95 punten VAS pijn 0-10 Doppler yes/ no Volumetry hand > 1cm figure of eight Volumetry fore arm circumferentieel 8cm distaal van mediale epicondyle >1 filament sensibility >60N decrease palmar grip (max 680N) >12N decrease key grip (max 137N) >15% decrease isometric strength (flexion and Extension) wrist and elbow
- Mean age 64 vs 67 Higher prevalence of family history of CAD 50 vs 26% + 45 % pre-existing hand disease intervention hand in both groups and 57% underwent revious TR procedures
- SS tintelingen/ doofgevoel (CTS) X-axis drivers/ variabels Y-axis % impairment Light purple 2weeks, dark purple 6 month At 2 weeks Major drivers: 30% patients have increase in volumetry hand, 27% decrease in sensibility, 34% increase in DASH questionnaire At 6 month: 35% patients have increase in volumetry hand, 32% increase SS questionaire(symptom severity score; tintelingen/ doofgevoel), 30% decrease in flexionwrist 2 weeks and baseline compared: significant more patients experience pain, decreased palmar grip and increased SS score at 6 month
- SS tintelingen/ doofgevoel (CTS) X-axis drivers/ variabels Y-axis % impairment Light purple 2weeks, dark purple 6 month At 2 weeks Major drivers: 30% patients have increase in volumetry hand, 27% decrease in sensibility, 34% increase in DASH questionnaire At 6 month: 35% patients have increase in volumetry hand, 32% increase SS questionaire(symptom severity score; tintelingen/ doofgevoel), 30% decrease in flexionwrist 2 weeks and baseline compared: significant more patients experience pain, decreased palmar grip and increased SS score at 6 month
- SS tintelingen/ doofgevoel (CTS) X-axis drivers/ variabels Y-axis % impairment Light purple 2weeks, dark purple 6 month At 2 weeks Major drivers: 30% patients have increase in volumetry hand, 27% decrease in sensibility, 34% increase in DASH questionnaire At 6 month: 35% patients have increase in volumetry hand, 32% increase SS questionaire(symptom severity score; tintelingen/ doofgevoel), 30% decrease in flexionwrist 2 weeks and baseline compared: significant more patients experience pain, decreased palmar grip and increased SS score at 6 month
- SS tintelingen/ doofgevoel (CTS) X-axis drivers/ variabels Y-axis % impairment Light purple 2weeks, dark purple 6 month At 2 weeks Major drivers: 30% patients have increase in volumetry hand, 27% decrease in sensibility, 34% increase in DASH questionnaire At 6 month: 35% patients have increase in volumetry hand, 32% increase SS questionaire(symptom severity score; tintelingen/ doofgevoel), 30% decrease in flexionwrist 2 weeks and baseline compared: significant more patients experience pain, decreased palmar grip and increased SS score at 6 month
- Demographics of patients referred to hand expert
- Femoral control group is important. UED target arm influence on non-target arm (E.g. Questionaires for both arms to open a bottle you need both arms) Other factors that influence non-target arm from baseline: beta blocker, statin, contrast , inactivity etc)