TAVI at Liverpool Heart & Chest Hospital. National Audit of Cardiac Services in Wales Wrexham 28/11/2012

Transcription

1 TAVI at Liverpool Heart & Chest Hospital National Audit of Cardiac Services in Wales Wrexham 28/11/2012 Mr Aung Oo

2 FIRSTTAVI TAVI IMPLANT IN SEPTEMBER 2008

3 LHCH TAVI Team Cardiologists Rod Stables, Joe Mills Cardiac Surgeons Aung Oo, Manoj Kuduvalli Anaesthetists Omar Al Rawi, Tim Ridgway, Johnathan Kendall ANP M Roberts TAVI MDT coordinator S Bradley Linked Theatre Nurse Y Heslop

4 TAVI Clinic Alternative week AO/MK Joint assessment withrhs/jm Anaesthetic assessment TTE, CT Further discussion in TAVI MDT Once agreed proceed for funding application Once funding approved preop clinic

5 TAVI Team TAVI MDT Meeting Independent Cardiac Surgeon Anaesthetist/Intensivist Eh Echo Cardiologist/Radiologist i l i t ECG/ /pacing technician MDT coordinator MDT outcomes 10% no treatment 5% Conventional

6 Hybrid Theatre

7 Edwards SAPIEN XT Transcatheter Heart Valve NovaFlex Transfemoral Delivery System Edwards SAPIEN XT THV Ascendra2 Transapical Delivery System

8 Edward Sapien XT

9 Edwards TAVI TF Procedure General anaesthesia Pre procedure TOE Temporary ypacing wire to RV via FV Surgical femoral access Percutaneous puncture for angiographic catheter Valve crossing with straight wire and stiff wire exchange Balloon valvuloplasty under rapid pacing and aortogram Two stage valve deployment with aortogram under rapid pacing TOE and completion angiographic assessment of valve Routine iliac and femoral artery angio Surgical femoral closure and pacing wire removal 6F Angioseal closure for puncture site

10 Edwards TAVI TA Procedure General anaesthesia Pre proceduretoe Temporary pacing wire to RV via FV or Jugular vein or Epicardial LV pacing wire Percutaneous angiographic catheter via femoral or radial artery Small left anterior thoracotomy Needle, wire, JR 4 and stiff wire exchange Ascentra 2 sheath insertion over stiff wire Balloon valvuloplasty and aortogram under rapid pacing Respiration off, rapid pacing and aortogram for marking position Two stage valve deployment under rapid pacing TOE and completion angiographic assessment of valve Removal of sheath and apicalclosure and TPW removal

11 Improvements in deployment techniques Affords better control of deployment process and positioning of valve Marking of hinge points on the screen Two stage deployment of the valve

12 Marking of hinge points

13 Deployment stage 1

14 Deployment stage 2

15 TAVI: Annual activity 43 TAVI operations in 2011/12

16 TAVI: Demographics vs. Isolated AVR England / IOM Wales TAVI 34 (79.1%) 9 (20.9%) Age at operation* 85.5 (59.3 to 95.9) 83.6 (70.8 to 90.3) Female 21 (63.6%) 4 (44.4%) Logistic EuroSCORE* 20.1 (6.7 to 59.6) 32.8 (3.2 to 52.2) Transapical procedure 15 (44.1%) 8 (88.9%) AVR 224 (72.3%) 86 (27.7%) Age at operation* 72.8 (25.9 to 95.9) 71.8 (50.5 to 89.7) Female 105 (46.9%) 42 (48.8%) Logistic EuroSCORE* 8.7 (1.5 to 71.4) 6.3 (1.5 to 48.8) * Continuous variables shown as median (range)

17 TAVI: In Hospital Outcomes England / IOM (n=34) Wales (n=9) Mortality 1 (2.94%) 2 (22.2%) Stroke 0 (0%) 0 (0%) Reoperation for bleeding 0 (0%) 0 (0%) Renal failure 2 (5.9%) 0 (0%) Infection 0 (0%) 2 (22.2%) ITU LOS* 1 (1 to 33) 1 (0 to 5) Post op LOS* 11 (3 to 21) 6 (0 to 30) * Continuous variables shown as median (range)

18 Transapical 8 Transfemoral 1 Mortality 2 Valve Details 90 yr male Transapical 23 Myocardial failure 79 yr female Transfemoral 23 Aortic root trauma

19 TAVI results outcomes Device success: 9 (100%) procedural success (access, delivery, deployment and retrieval) 9 (100%) correct position prosthetic valve dysfunction 0 moderate paravalvar AR 9 mild or nil paravalvar AR 9 (100%) single valve procedure

20 TAVI results outcomes Combined safety endpoint at 30 days: 2 deaths 0 strokes 0 life-threatening/ disabling bleeds 0 stage 2 or 3 kidney injury 0 myocardial infarctions 1 vascular complication Aortic root trauma 0 conduction disturbance/ arrhythmias 0 repeat procedures

21 TAVI results outcomes Combined efficacy endpoint up to 1 year : 0 non-cardiovascular deaths 0 valve-related dysfunction 0 repeat procedure 0 prosthetic valve endocarditis 0 prosthetic valve thrombosis 0 thromboembolic event

22 Good LV 6 Mildly impaired LV 1 Follow up Echo AVG No significant ifi gradient 5 8 mmhg (TA29) 1 14 mmhg (TA26) 1 AR 0/4 5 1/4 2

23 LHCH TAVI Results Sept 2008 March patients 52 female (53.6%) 53 Transapical (54.6%) Mean age 82 yr Median age 84 (57 95yrs) Mean Logistic Euroscore 19.7 Median Logistic Euroscore 16.6 (4 63.7)

24 LHCH TAVI Results Elective 90 (92.7%) Technical success in 92 (94.8%) 1 patient required valve in valve to achieve technical success due to severe PV leak after first valve deployed though the valve was stable

25 LHCH TAVI Results Mortality 6.2% (6/97) In hospital and 30 day Perioperative mortality 3.2% (3/97) Reop for bleeding 1.03% (1/97) Bleeding from transvenous pacing wire CVA 3.1% (3/97) (all patients died) Renal limpairment i 48% 4.8% PPM 4.8%

26 Lengths of stay LHCH TAVI Results ITU length of stay (77 patients) Median Average 1 day (1 13 days) 2.6 days Total Postop length of stay (all 97 patients) Median 7 days ( 3 61 days) Average 9.2 days

27 LHCH TAVI Results Discharge destinations 73 patients (75.2%) Home 12 patients (12.4%) Other hospital 6 patients (6.2%) Convalescence

28 Causes of death LHCH TAVI Results Haemoynamic instability post deployment (though valve in correct position) 3 Two had hypoxic brain damage and died many days later One died on table Low deployment of valve needing emergency CPB and sternotomy 1 Died on table Delayed respiratory/neuro and other complications 1 Injury to ascending aorta post deployment 1 Died on table

29 LHCH TAVI Results Causes of technical failure Displacement of valve into LV and then into DTA Overestimation of aortic stenosis (26mm valve embolized across the stenotic aortic valve into the DTA Valve stuck in DTA in reverse position no distal flow Explanted with left heart bypass Good recovery Displacement of valve into LV One due to low placement One during CPR due to haemodynamic instability Both patients had emergency conventional AVR one survived and did well

30 LHCH TAVI Results Causes of technical failure Occlusion of dominant RCA after the deployment Emergency sternotomy and RCA graft on pump beating heart Survived and did well Inability to cross the native aortic valve due to excessive calcification Procedure abandoned d

31 Intra operative ti salvage procedures CPB 6 X clamp and cardioplegia in 3 Standard AVR 2 Repair of ascending aortic injury 1 Support bypass 2 RCA graft 1 Left heart bypass 1 3/7 (43%) survived to be discharged from hospital

32 LHCH TAVI Results Peripheral arterial complications from TF TAVI One each of Iliac artery injury recognized on table needing stenting CFA injury needing interposition graft repair Femoral artery pseudoaneurysm Femoral artery stenosis with delayed claudication pain

33 LHCH TAVI Results Delayed re-intervention One patient Technically satisfactory result after the procedure, though valve was slightly low, but stable Pre-discharge echo 4 days postop valve had migrated into LVOT Aortic stenosis still severe Impinging on AML Conventional AVR after explanting valve Did well, discharged home

34 Results from UK TAVI Registry 870 patients data upto Dec 2009 J AmColl Cardiol 2011;58:

35 Comparative Results LHCH UK Registry Total cases TA cases 55% 25% Mean Age All 30 day mortality 6.2% 7.1% TA 30 day morality 7.5% 10.7% TF 30 day mortality 4.5% 5.5% Stroke 31% 3.1% 41% 4.1%

36 TAVI: Survival (overall) Survivor 1.00 Survival Plot (PL estimates) Proportio on survivin ng Numbers at risk: YTi Years mes

37 TAVI: Survival (by referral region) Survivor Survival Plot (PL estimates) 0 1 Pro oportion surviving Years Ti mes England / IOM: Wales:

38 TAVI: Survival (by procedure type) Survivor 1.00 Survival Plot (PL estimates) Transapi cal Transfemoral surviving Pr roportion Transapical: Transfemoral: Ti mes Years

39 TAVI: Waiting times (days) England / IOM (n=34) Wales (n=9) Duration of elective wait* 80.5 (0 to 753) 100 (13 to 196) Financial approval to procedure date* 101 (1 to 230) * Continuous variables shown as median (range)