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Safe Introduction of Ventricular Assist Devices into National Clinical Practice Ahmed Al-Adhami MBChB(Hons) MSc PGCert MRCSEd Department of Transplantation & Mechanical Circulatory Support Golden Jubilee National Hospital United Kingdom


Heart Failure Epidemiology ● CHF Prevalence in European populations: 0.4-2% ● Mean age: 74 years ● The prevalence increases with age

• 1% at 25-54 years • 4-5% at 65-74 years ● 50% mortality within 4 years ● 10 million CHF patients in EU countries ● MCS has revolutionised management ESC Task Force on Heart Failure 2001


INTERMACS PROFILE-LEVEL

Official Shorthand

General time frame for support

INTERMACS LEVEL 1

“Crash and burn”

Hours

INTERMACS LEVEL 2

“Sliding fast”

Days to week

INTERMACS LEVEL 3

Stable but Dependent

Weeks

INTERMACS LEVEL 4

“Frequent flyer”

Weeks to few months, if baseline restored

INTERMACS LEVEL 5

“Housebound”

Weeks to months

INTERMACS LEVEL 6

“Walking wounded”

Months, if nutrition and activity maintained

INTERMACS LEVEL 7

Advanced Class III


Scotland ● ~ 5 million people ● 3000 patients aged <65 first hospitalisation for HF/ annum ● 20-30% mortality at 1 year ● At least 1000 die of HF aged <65 each year


INFRASTRUCTURE & PREPARATION ARE KEY TO A SUCCESSFUL & DURABLE VAD SERVICE


Building the service ● ● ● ● ● ● ● ● ● ●

Define the team Education and Collaboration Guidelines Organisation and Coordination Monitoring Academic advancement Financial Support Political considerations Technical considerations for first implant Referral and outreach strategy


The VAD team

Givertz M M Circulation 2011;124:e305-e311


Method ● Retrospective ● Observational ● First 30 months (Jan 2010 – Jul 2012) ● ST-VADs as BTD (‘Crash and Burn’) ● All LT-VADs


Bridge to decision â&#x2014;? 13 patients, All CentriMag STVAD Characteristics Age, mean (range), years

42.4(16-62)

Female

7 (53.8%)

Ischaemic cardiomyopathy Acute myocarditis Dilated cardiomyopathy Hypertrophic cardiomyopathy Diagnosis Muscular dystrophy cardiomyopathy Drug induced cardiomyopathy Severe aortic stenosis and poor LV Other

3 (23.1%) 3 (23.1%) 2 (15.4%) 1 (7.7%) 1 (7.7%) 1 (7.7%) 1 (7.7%) 1 (7.7%)


Bridge to decision ● MCS type • 8 (61.5%) ST BiVADs, • 3 (23.1%) ST LVADs • 2 (15.4%) peripheral CentriMag ECMO. ● 9 (69.2%) survived to outcome/last followup • 5 (45.5%) bridged to myocardial recovery • 2 (15.4%) bridged to LT support • 1 (7.7%) bridged to transplantation • 1 (7.7%) is on ST-VAD support


Background High mortality and poor rate of recovery ●De Robertis (Harefield) 2006 (JHLT 2006;25:181–6) • 6 BTD pts, 5 (83.3%) died • None attained myocardial recovery ●Shuhaiber (Papworth) 2008 (JHLT 2008;27:158–64) • 9 AHF pts, 7 (78%) died • 2 (22%) survived to transplantation • None recovered ●De Robertis (Harefield) 2008 (JHLT 2008;27:474–8) • 16 BTD pts • 2 (12.5%) recovered with successful explantation • 6 (37.5%) upgraded to long-term device, 3 (18.8%) BTT • 5 (32.3%) died


Bridge to decision ● Mean durations of ST support - 31.3 (2110) days ● Renal support - 6.6 (0-31) days ● Postoperative ICU stay - 35.5 (1-119) days ● Mortality (38.5%)

• 4 early deaths • 1 after discharge


Bridge to decision ● Complications

• • • •

1 (7.7%) stroke, 2 (15.4%) acute-limb-ischemia 6 (46.2%) re-explored No device failures


Longterm support â&#x2014;? 8 patients, all underwent HeartMate II Implantation Demographic Characteristics Age, mean (range), years Female Ischaemic cardiomyopathy Dilated cardiomyopathy Diagnosis LV non-compaction Postpartum cardiomyopathy Giant cell myocarditis

35.4 (16-53) 2 (25.0%) 4 (50.0%) 1 (12.5%) 1 (12.5%) 1 (12.5%) 1 (12.5%)

Haemodynamic Characteristics Preoperative mechanical support INTERMACS

IABP

4 (50.0%)

Bridged from ST-VAD / CentriMag ECMO

1 (12.5%)

I & II

5 (62.5%)

IV

3 (37.5%)


Longterm support outcomes ● Mean postoperative ICU stay - 19.9 (6-56) days ● Mean LT support - 251.3 (21-751) days ● Outcomes

• 6(66.7%) remain on LT-support, • 1(11.1%) bridged to myocardial recovery • 1(11.1%) bridged to transplantation ● Cumulative survival was 87.5% at 24 months postoperatively


Longterm LVAD outcomes ● Complications

• • • •

1 died after 98 days of LT support 2 LVAD induced HF 2 Re-explored for bleeding One minor superficial driveline infection


Problems ● Subsequently implanted HMII 5 INTERMACS I & II patients ● 3 died subsequently


Conclusion â&#x2014;? Complex VAD therapy can be integrated safely â&#x2014;? Robust infrastructure is vital


SHA24/037006