EUROPACE 2011 Johan Vijgen, MD, FESC Jessa Hospital Hasselt, Belgium

Transcription

1 ICD and Driving: What is Safe? EUROPACE 2011 Johan Vijgen, MD, FESC Jessa Hospital Hasselt, Belgium

2 Background Increasing number of ICD implants, more primary indications, patients are younger and more active Driving restrictions have important impact on patient s well being, social life and economic status Public safety is important Legislation differs between Eur. countries Low adherence to recommendations Friedlund et al: J Clin Nursing 2000; Kelly et al: Postgrad Med J 1999; Maas et al: BMJ 2003; Craney et al: Progr Cardiovascular Nursing 1995

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4 Risk Assessment RH = TD x V x SCI x Ac RH: Risk of harm /year TD: time or distance behind the wheel/year V: constant depending on the vehicle SCI: risk for l.o.c. or scd/year Ac: chance l.o.c. leads to serious accident Canadian Cardiovascular Society Consensus Conference 1992

5 Professional drivers RH = TD x V x SCI x Ac RH: 0.005% per year TD: 0.25 V: 1 SCI: 1% per year Ac: 0.02 Canadian Cardiovascular Society Consensus Conference 1992

6 Private driving RH = TD x V x SCI x Ac RH: 0.005% per year TD: 0.04 V: 0.28 SCI: 22% per year Ac: 0.02 Canadian Cardiovascular Society Consensus Conference 1992

7 Risk Assessment in Patients implanted for Secondary Prevention Likelihood of a recurrence of the arrhythmia Likelihood of impaired consciousness Probability of a car accident Probability of death of injury to others

8 Risk of Recurrence of Arrhythmia Incidence of appropriate shocks in AVID, CIDS and CASH 5 year actuarial incidence 55 70% High incidence in first year, steady state in year 2 to 4, increase in fifth year Tchou et al: PACE 1991

9 ICD Registry Poland 2162 patients, 58 ± 48 y/o Secundary prevention 52% propability of ICD intervention for VF or fast VT during 10 years of follow-up Mean time to first VT/VF: 344 ± 416 days Propability in first month: 2.2%, second month: 2.9%, < 2% thereafter Lubinski et al: HRS 2008

10 Risk of Syncope Incidence of syncope with ICD therapy 10 30% Clinical predictors: Low EF VT CL < 250 Atrial Fibrillation Kou et al; Freedberg et al; Lerecouvreux et al; Bansch et al; Abello et al

11 Risk of harm to bystanders Harm to patient and bystanders Annual incidence of accidents 3.4 % per patient year vs 7.1 % in general population Fatality rate 7.5 per patient years vs 18.4 in general population Indirect data (surveys, retrospective, ) RH formula: Ac = 0.02 Curtis, JACC 1995; Hickey, AHJ 2001; Freedman, JACC 2001; Akiyama, NEJM 2001 Lerecouvreux, Arch Mal Cœur 2005; Abello, EHJ 2006; Registry Poland, HRS 2008

12 Recurrent Cardiac Events in Survivors of Ventricular Fibrillation or Tachycardia G. C. Larsen, M. R. Stupey, C. G. Walance, K. K. Griffith, J. E. Cutler, J. Kron and J. H. McAnulty Cardiology Section, Portland Veterans Affairs Medical Center. Prospective study on 501 VT/VF patients EP guided therapy (8 % ICD) 4.22 % recurrence in first month 1.81 % recurrence in months 2 to % recurrence in months 8 to 12 JAMA, May 4, 1994-Vol 271,No.17

13 Recurrent Cardiac Events in Survivors of Ventricular Fibrillation or Tachycardia G. C. Larsen, M. R. Stupey, C. G. Walance, K. K. Griffith, J. E. Cutler, J. Kron and J. H. McAnulty Cardiology Section, Portland Veterans Affairs Medical Center, OR JAMA, May 4, 1994-Vol 271,No.17

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15 TOVA STUDY Comparison risk of ICD shock for VT/VF during and up to 60 minutes after driving compared with that during other activities 1188 ICD patients Median follow up 562 days Occurrence of 414 shocks, 324 for VT/VF Albert, C. M. et al. J Am Coll Cardiol 2007;50:

16 TOVA STUDY ICD shocks for VT/VF were twice as likely to occur within 1 hour of driving a car as compared to other times Risk occurred primarly during the 30-min period after driving rather than during the driving episode itself (1 episode per person-hours driving) Risk was not elevated during driving and the absolute risk was low Albert, C. M. et al. J Am Coll Cardiol 2007;50:

17 Recommendations for private driving for patients in secondary prevention: - Driving restriction of 3 months Assessment of functional class and cognitive functions before resumption of driving

18 Risk Assessment in Primary Prevention Annualized mortality rates range from 1.6% in MADIT II to 12 % in COMPANION Average annual mortality in ICD arm 7% Rates of sudden cardiac death 0.5 to 1.8% per year

19 Risk Assessment in Primary Prevention Trial Discharge Rate, % of Patients Comments CABG-Patch 50% at 1 year; 57% at 2 years MADIT I ±60% at 2 years 43.9% of patients: 142 therapies (27m) (shocks 17.6% ~ 4.4%/year) MADIT II 7.9% of patients per year 13.4% of patients received 701 device therapies (shocks59% of therapies) DEFINITE 7.4% of patients per year 41 patients; 91 shocks SCD-HeFT 7.5% of patients per year Appropriate shocks; 5.1% of patients per year Average ICD discharge rate is 7.5% per year

20 Risk Assessment in Primary Prevention Recovery from implantation Wound healing, dislocation, pocket heamatoma, perforation 307 patients: 9.9% within 30 days post implant 1000 patients: 1.8% pocket complications, 2.1 % lead complications. Lead dislocation occurred primarily during first month. 416 patients: 1.9% perforation. Symptoms developed within 3 weeks. Interrogation on the day after implant did not reveal any abnormalities Raviele et al; Gold et al; Danik et al.

21 Recommendations for private driving for patients in Primary Prevention: - Driving restriction of 4 weeks System integrity check is recommended

22 Recommendations for driving after ICD replacement: Driving restriction of 1 week Recommendations for driving after lead replacement: Driving restriction of 4 weeks

23 Risk Assessment after Appropriate Freedberg et al: ICD Therapy 125 patients 46% ICD therapy after 152 ± 193 days 79 % had second therapy Mean time to second therapy 66 ± 93 days 2 of 30 patients who were asymptomatic at first ICD therapy had syncope with second Kou et al: Absence of syncope during first ICD therapy did not predict absence of syncope during subsequent shocks

24 Risk Assessment after Appropriate Primary prevention: ICD Therapy MADIT II: Increased risk of death (HR 3.4) after appropriate ICD therapy 17.8 fold increased risk of death in 3 months after electrical storm SCD-Heft: 5.7 fold increase in mortality after appropriate shock Moss et al; Sesselberg et al; Poole et al; Singh et al.

25 Risk Assessment after ICD therapy Inappropriate ICD therapy: 11 to 32% in major trials Atrial fibrillation, supraventricular arrhythmias, inappropriate sensing. Measures to reduce inappropriate shocks: Discrimination algorithms Anti-arrhyhtmic medication Reprogramming of the device Electrode replacement Incidence of syncope is unknown

26 Recommendations for private driving after ICD therapy Appropriate therapy: Driving restriction of 3 months after appropriate therapy Inappropriate therapy: Driving restriction until measures to prevent subsequent inappropriate therapy are taken

27 Definition Professional Driving

28 European Union Council Directive 91/439/EEC of 29 July 1991 on driving licences MINIMUM STANDARDS OF PHYSICAL AND MENTAL FITNESS FOR DRIVING A POWER-DRIVEN VEHICLE DEFINITIONS 1.1.Group 1: drivers of vehicles of categories A, B and B+E and subcategory A1 and B1 1.2.Group 2: drivers of vehicles of categories C, C+E, D, D+E and of subcategory C1, C1+E, D1 and D1+E. 1.3.National legislation may provide for the provisions set out in this Annex for Group 2 drivers to apply to drivers of Category B vehicles using their driving licence for professional purposes (taxis, ambulances, etc.).

29 Risk Assesment for Professional Drivers Yearly risk of sudden incapacitation < 1% Primary prevention 7.5 % ICD discharge Channelopathies? Brugada syndrome: Annual appropriate shock rate 2.6% Significant risk of inappropriate shocks Sacher et al: Circulation 2006

30 Recommendations for professional driving Permanent restriction

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32 2786 patients 1718 primary prevention (62%) Follow-up of 996 days ( )

33 Appropriate ICD shocks Primary Prevention First shock: 190 patients (10 %) Median time : 417 days ( ) Second shock: 65 patients (34%) Median time: 66 days (29-379) Secondary Prevention First shock: 342 patients (32%) Median time: 509 days ( Second shock: 166 patients (49%) Median time: 400 days (

34 Annual Risk of Harm

35 Conclusions (1) Driving restrictions have important consequences for patients and families The purpuse of the Task Force on ICD and Driving of EHRA was to publish uniform recommendations for Europe. To increase adherence to the driving restrictions, adequate discharge education and follow-up of patients and family are pivotal. We hope this document may serve professionals and regulatory authorities as an instrument for uniform European driving regulations

36 Update of Directive Annex III of 91/439/EEC and Directive 2006/126/EC 2009: ESC requests update European Directive on fitness to drive for ICD patients based on consensus report* 18/2/2010: The Driving licence Committee agreed to create an expert group to bring the Annex III of Directive 91/439/EEC and Directive 2006/126/EC up to date with the latest professional insights with regards to Cardiovascular diseases * 26/6/2010: kick-off meeting of expert group a. to collect and examine data ( scientific evidence and founded expert opinion) b. to identify gaps and problems in Annex III c. to formulate recommendations to change and prepare a (expert consensus) report *Consensus statement of EHRA: updated recommendations for driving by patients with implantable cardioverter defibrillators. J. Vijgen et al. **Following adaptation on Diabetes, Epilepsy and Eyesight.

37 Expert Group Chairman: Gilles Bergot: European Commission, Road Safety Frederik Jansen European Commission, Road Safety President: Dr. Vijgen (B); Secretary: Dr. Tant Invited experts: - Dr. Jung (Germany) - Dr. Schalij (NL) - Dr. Mancia (Italy) - Dr. Moya (Spain) - Dr. Iserin (France) - Dr. Steen (Norway) - Dr. Falk (Suisse) - Dr. Lerecouvreux (France) - Dr. Rugina (Romania) - Dr. Albrecht (Germany) - Dr. Kumar (GB) - Dr. Moerz (Austria)

38 Expert Group Timeline - November 2010 September 2011: - Meeting of experts in Brussels to discuss proposed changes - October 2011: - first draft of proposal - End 2011: - Presentation Final Report to EC.