Root Cause Analysis for nontraumatic

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Root Cause Analysis for nontraumatic amputations 2016 (Full Data) Date Richard Leigh and Stella Vig, Co-Chairs London SCN Footcare Network October 2015

Outline of London RCA 2016 London Hospitals invited to send retrospective RCA data regarding their last 5 non-traumatic amputations Data to be included from both community and secondary care to review the whole patient pathway 114 questions covered o o o o o o o o o o Audit of service Patient demographics History of patients diabetic foot disease Referral and admission Procedure Assessment in Secondary Care Investigations Diagnosis and assessment: Diabetes specific Diagnosis and assessment: Renal specific Discharge / Outcome 2

Data provided Data was collated by 3 hospitals each one a vascular hub. o o o Royal Free London NHS Foundation Trust Imperial College Healthcare NHS Trust King's College Hospital NHS Foundation Trust Data regarding community services was only sent from one Hospital o Royal Free London NHS Foundation Trust Data from 14 patients who underwent major nontraumatic amputation were included in the RCA 3

National Cardiovascular Intelligence Network (NCVIN) Non-traumatic amputations for all London CCGs for the period 1/4/2012 to 31/3/2015 Major amputations 656 (over 218 a year) Minor amputations 1669 (over 555 a year) Total 2325 (775 a year) London undertakes 10.5% of all non-traumatic amputations in England There is variation of outcome within each STP 4

National Cardiovascular Intelligence Network (NCVIN) Highest and lowest Amputation rates for London CCGs for the period 1/4/2012 to 31/3/2015 London CCG Major Amputations Minor Amputations Lowest 9 20 Highest 36 100 Variation 4 fold 5 fold 5

Data for one patient was incorrect and age was not specified 6

7

Reason for Admission L finger tip necrosis. Worsening foot wound from 12/06/2016 Necrotic foot, ischaemic leg 3/7 history of left leg pain and feeling unwell. Ischaemic L foot and necrotic L hallux septic, with foot ulcer and acute foot arch thrombosis Critical leg ischemia, extensive heel gangrene CARDIAC ARREST critical leg ischemia, with non healing ulcers and gangrene and occluded femoral to posterior tibial artery bypass critical leg ischemia Bilateral Ischaemic Legs Generally Unwell Critical Limb Ischaemia Extensive left calcaneal osteomyelitis with a septic joint Ischaemic Left Foot 8

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Comment: Vascular surgery, patient declined 11

Critical Event - If multiple / other - please give details Necrotic tissue extending and becoming wet Severe irreversible ischaemia Severe irreversible ischaemia Infected ulcer that had emergency debridement, however the foot arch thrombosed and foot became non viable while patient was on ITU Extensive heel tissue loss, that failed to improve despite revascularization and debridement Crural and pedal vessel thrombosis following cardiac arrest complicated by high doses of inotropes and compartment syndrome patient generally was very frail, with dementia and sever bi-ventricular cardiac failure and not candidate for re-do bypass Admitted with critical leg ischemia, has occluded femoral to anterior tibial bypass. Considered for re do surgery, but sustained myocardial infarction following admission. Coronary angiogram showed extensive coronary disease. After coronary angio, underwent femoral and profound endarterectomy and patch plasty. However, despite revascularization, the foot ischemia condition regressed significantly. Bleed in fasciotomy wound leading to amputation 4 n/a 1 No response 12

Comments about amputation Initially presented in Jan, but went overseas against medical advice. Returned in April and had amputation of L hallux and L leg angiogram. No vessels to foot. Advanced ischaemia Patient had attempt for revascualrization, but all foot vessels were fully thrombosed due to the septic shock. Patient was not suitable for thrombolysis Patient had Major amputation due to fully exposed ankle joint and heel necrosis Patient had amputation due to non viable ischemic muscles following cardiac arrest Patient generally was very frail, with dementia and sever biventricular cardiac failure and not candidate for re-do bypass 8 None 13

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Other community health issues Initially presented in Jan, but went overseas against medical advice. Returned in April and had amputation of L hallux and L leg angiogram. No vessels to foot. Readmitted 2/6/16 with worsening gangrene. No clear history from patient or home. Presented to secondary care with gangrenous toes and critically ischaemic leg No data Wheelchair user prior to admission. Poor history due to dementia and schizophrenia 5 None 5 No data 17

One comment: Oral Antibiotic Regimen in Community Failed 18

Antibiotics prescribed Doxycycline 100mg od, Co-trimoxazole 480mg bd IV Augmentin IV Augmentin 11 No data 19

20

Multiple bypasses Had previous fem-pop bypass, and had acute graft occlusion in 12/2015 for which had attempt thrombectomy and re-do fem-to posterior tibial artery bypass FEM- ATA and more recent common and profunda femoris endarterectomy 10 No Data 2 No 21

Other comments Oral Antibiotic Regimen in Community Failed Late presentation, but rapid deterioration likely [Patient had] Mental health issues 22

Dates if diagnosis of diabetes; No Data entered Retinopathy; 1 Non-sight threatening 1 No Retinopathy 5 Unknown 7 No Data 23

1 patient PD (home) 2 patients HD (hospital) 24

Post discharge care provider: 1 comment: Discharged to spoke hospital pending nursing home/ rehab plans. No data regarding foot risk information at discharge 25

Key Findings for RCA Major Amputations Age ranged from 49 95 years 50% White, 22% Black, 14% Asian 64% Male Half the patients had no foot care provider There was not enough data collated to conclude from presentation in primary/community care Majority of referrals were from A &E (36%) and other hospitals (21%) Majority of amputations due to Critical Leg Ischaemia (64%) 57% BKAs Only half the patients were previously aware of the risk of amputation Only 21% of amputations were anticipated by the clinician Some causes of amputation were extremely complex eg cardiac arrest and inotropes In secondary care 57% had rest pain and 50% infection and gangrene, 43% ulceration 72% had PVD, 57% were neuropathic 64% were current or ex-smokers 43% had been treated for a previous ulcer Antibiotics were given to 57% of patients in secondary care at least half OPAT (there was little data regarding type of antibiotic) 79% received a Duplex scan as initial mode of imaging 50% of patients had no revascularisation Diabetes; 7% Type 1, 64% Type 2. Data was not entered for half last known HbA1C. ESRF in at least 21% of patients, 36% IHD, 79% Hypertension There was a lack of any primary/community care data. 26

RCA study design outcomes and comments RCA data was completed by vascular surgery teams. The majority of patients had PAD and may have been self selecting as they were seen by vascular teams. The lack of data from community care probably relates to the number of patients with critical ischaemia who were never seen by a community team. There was difficulty obtaining data from primary care. Reviewing the RCA patient group and comparing with national outcomes, a cohort of patients are missing; Those amputations with no history of ischaemia. 27

Ongoing RCA for London How should we approach RCA for London? Should we be collecting prospective data? How do we collate data from across community and primary care to ensure the whole pathway is captured? Who should collate this data? Without data good capture across the whole pathway we are unlikely to be able to target areas for improvement. We should all be inputting to the NDFA in all community and secondary care sites. 28