Difficult conversations: informed consent to implantation of cardiac devices. Janet M McComb Newcastle upon Tyne

Transcription

1 Difficult conversations: informed consent to implantation of cardiac devices Janet M McComb Newcastle upon Tyne janet.mccomb@nuth.nhs.uk

2 DEACTIVATION of ICD THERAPY IN PEOPLE REACHING THE END OF THEIR LIFE the possibility of deactivation of an ICD and the reasons for it should be explained as part of informed consent to ICD implantation GMC requirements for consent Benefits and complications of the procedure Discussion should be supported with written material Scope of decisions if treatment is provided in stages

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4 You must give patients the information they want or need about: the potential benefits, risks and burdens, and the likelihood of success, for each option;

5 Potential benefits of pacemaker implantation Prevention of dizzy spells, blackouts, fatigue or exercise intolerance in people with permanently or intermittently slow heart rates

6 Complications of pacemaker implantation Source Swedish Pacemaker Registry Danish Pacemaker Registry FOLLOW PACE (Netherlands) Italy 2 centre study Freeman Hospital Lead displacement /dysfunction Haematoma Pneumo thorax Infection TOTAL 2.9% 0.3% 0.5% 0.6% 5.3% 3.6% 0.7% 8.4% 5.5% 2.9% 2.2% 0.66% 12.4% 0.8% 0 0.4% 0.1% 1.7% 3.2% 0.7% 1.9% 1.0%

7 Potential benefits of ICD implantation Prevention sudden cardiac death in those deemed at risk

8 % complications

9 Potential benefits of CRT implantation 5 4 control CRT NYHA MLWHF EuroQol

10 % complications

11 You may need to support your discussions with patients by using written material.. If you do, you must make sure material is accurate and up to date

12 19 patient information leaflets provided by implanting centres 3 leaflets provided by patient orientated charities

13 Risks not mentioned, or described as small

14 Complications of pacemaker implantation: information available in patient leaflets 3 contain no information about risks 6 refer to risks as small or rare 6 quantify risks of individual complications eg lead displacement 0.2% - 5% cf studies 3-6% 0 gives total risk cf studies 5 12%

15 7 patient information leaflets provided by implanting centres 2 leaflets provided by patient orientated charities

16 Complications of ICD implantation: information available in patient leaflets 2 contain no information about risks 1 refer to risks as small 2 quantify risks of individual complications eg lead displacement 4-5% haematoma 3 4% 0 gives total risk cf studies 8-14%

17 Complications of CRT implantation: information available in patient leaflets 2 contain no information about risks 1 refers to risks as small 1 quantifies risks of individual complications eg lead displacement 5% 0 gives total risk cf studies 10-18%

18 You must explain clearly to patients the scope of any decisions to be made. This will apply particularly if: treatment will be provided in stages, with the possibility that changes or adjustments will be needed

19 mean age at implantation Pacemakers & ICDs generator patient ICD PPM % 5 years

20 % complications new system Major Minor Any generator change upgrade/lead revision

21 Requirement for generator change: information available in patient leaflets Pacemakers 12 do not mention generator longevity 4 mention generator longevity of 6-10 years ICDs 0 mentions generator change CRT 1 mentions generator longevity of 6-10 years BHF & AA leaflets mention generator longevity

22 Studies 6% risk of generator change, 15% if lead revision is required

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24 Conclusions Implanting a pacemaker or ICD usually commits a patient to life long device therapy Currently information provided during the consent process for pacing contains adequate information about acute risk (but, by inference, may underestimate it) Information about more complex devices either does not include risk, or underestimates it

25 Conclusions At the time of first implantation There is little information available to patients about longer term risks, especially relating to generator change and lead revision There is little if any information available to patients about the possibility of discontinuing device therapy