Complex Devices..... Biventricular Pacemaker: (aka Cardiac Resynchronisation Therapy) Treats subset of patients with heart failure Needs high quality X-ray for LV lead placement Device cost ~£2.5k Implantable defibrillator (ICD): Biventricular ICD Treats patients who have had or at risk of life- threatening ventricular arrhythmias. Device cost ~£10k Combines function of both devices for patients who meet implant criteria for both Device cost ~£12k CRT-P CRT-D ICD

NICE Guidance prior to 2014: TA95 (2006) NICE ICD criteria 2ry prevention Cardiac arrest survivors VT with syncope/compromise VT with EF<35% 1ry Prevention Post MI (>4/52) AND EITHER +EF<35+NSVT+inducible VT OR EF 120ms Hi risk familial condition i.e. HOCM TA120 (2007) NICE CRT criteria NYHA III-IV Sinus rhythm QRS>150ms or QRS >120 + Echo Dyssynchrony EF<35% Optimal Drug Therapy

Changes in TA 314: Shift from an ejection fraction of <30% to <35% for identification of patients for primary prevention devices The CHARM study: Circulation 2005;112: Increases target population by at least 1/3

Other Changes in TA314: Removal of reference to “Post MI” – patients with non- ischaemic aetiology also considered – % increase in population Removal of reference to “echo dyssychrony” when considering CRT for patients with LBBB and QRS between 120 and 150ms – 20-30% increase in CRT eligible Extensions of CRT-D use to patients in NYHA class II with QRS >120 (LBBB) and QRS >150 (any pattern), and patients in NYHA class I with QRS >150 – 10-20% increase in CRT-D eligible

Recommendations based on network meta-analysis of trial data from 12,638 patients in 13 major ICD, CRT-P and CRT-D trials TA314 Primary Prevention Device Indications: EF <35%

Changes in implant rates we might expect from TA314: Up to 100% increase in total implant numbers Increase in proportion of CRT-D implants More primary prevention implants More implants in non-ischaemic aetiology

Data Collection: Data form sent to Morriston/UHW/Royal Glam/North Wales Network Data Requested for two 6-month periods before and two 6-month periods after TA314 on CRT-P / CRT-D / ICD implant numbers Age % Ischaemic aetiology % Primary prevention (gender) Many thanks to all centres who all returned their data

All Wales Implant Numbers: Total implants

Regional Per Capita Implant Rates: Pre & Post TA 314 CRT- P CRT- D ICD Implant Rate Per million

Regional Long Term Implant Rates/million: All CRT (P&D) All ICD (+/-D)

All Wales Non-ischaemic Aetiology?

Average Age & Gender (SW only) data: CRT-P 73yrs 75% male CRT-D 68 yrs 90% male ICD 64yrs 73% male

ICD indication primary prevention:

What Changes were observed in the year after TA314? 18% increase in all ICD implants CRT-D increased from 41% to 49% of ICD implants No change in primary prevention implants (51%) Small increase in proportion of CRTD/ICD implants labelled non-ischaemic Increasing disparity between implant rates in SW Wales and the rest of Wales (? Capacity limitations in MCC + shortage of consultant cardiologists in West Wales)

Why weren’t changes more dramatic? New guidelines based on literature published over last decade – implanters have already adjusted their practice Primary prevention implants could be waiting longer for their implants and are not showing in totals yet (esp. In SW?)

Recommendations based on network meta-analysis of trial data from 12,638 patients in 13 major ICD, CRT-P and CRT-D trials Primary Prevention Device Indications: EF <35%

All Wales Box changes: All Wales Totals

Wales vs England (2014) NICOR data ICDAll CRT