THE PERCUTANEOUS MANAGEMENT OF VALVULAR HEART DISEASE DR JOHN RAWLINS CONSULTANT INTERVENTIONAL CARDIOLOGIST UNIVERSITY HOSPITAL SOUTHAMPTON

INTRODUCTION History of heart valve intervention Current indications Focus on TAVI The future..

HISTORY OF PERCUTANEOUS HEART VALVE INTERVENTION It all starts with balloons..

HISTORY OF HEART VALVE INTERVENTION Balloon valvuloplasty: Pulmonary - Seeb et al - 1979-2 day old boy with congenital pulmonary stenosis/severe TR (open) Kan et al - 1982-1st series/report of percutaneous BPV

WHAT ABOUT THE LEFT HAND SIDE? Mitral - Kanji Inoue - 1st Mitral BAV 1982 Trans septal delivery Remains treatment of choice for rheumatic mitral stenosis

MITRAL BALLOON VALVULOPLASTY

BMV IN THE MODERN ERA

AORTIC BALLOON VALULOPLASTY Criber et al - 1986 Balloon advanced across AV and inflated under rapid pacing. Good short term results Risky. Failure. Restenosis in 50% at 6/12, 90% at 1 year Reserved now as: Palliative procedure TAVI test (for response) Bailout

SO NOW WHAT? Don't fear failure - not failure, but low aim is the crime. In great attempts it is glorious even to fail.

PERCUTANEOUS VALVE REPLACEMENT

PULMONARY VALVE REPLACEMENT Bonhofer et al Bovine Jugular valve sewn into an platinum iridium stent 1st implanted into an RV-PA conduit in 2000 procedure refined - now manufactured by Medtronic as the Melody valve system

TRANS CATHETER PULMONARY VALVE REPLACEMENT

PULMONARY VALVE REPLACEMENT AT UHS first implant in 2007 >50 implants Indication - stenosis or regurgitation native or tissue prosthesis or conduit Trans femoral/trans jugular approach Medtronic Melody or Edwards XT/S3 balloon expandable valves currently licensed.

TRANS CATHETER AORTIC VALVE REPLACEMENT

TAVI Cribier et al Developed balloon expandable bovine valve stainless steel stent 1st in man - 2002 EF 12%, critical AS, failed BAV, cardiogenic shock, turned down from surgery - spectacular success!

TRANS CATHETER AORTIC VALVE REPLACEMENT

TAVI DEPLOYMENT

TAVI VALVES balloon expandable (edwards) Vs. Self expanding (medtronic) Enhanced frame geometry for ultra-low delivery profile Low frame height Bovine pericardial tissue Outer skirt to reduce PVL

THE FIRST DATA: Partner B: M Leon N Engl J Med 2010; 363:1597-1607 Symptomatic Severe Aortic Stenosis Inoperable N = 358 Severe Symptomatic AS with AVA< 0.8 cm 2 (EOA index < 0.5 cm 2 /m 2 ), and mean gradient > 40 mmhg or jet velocity > 4.0 m/s ASSESSMENT: Transfemoral Access 1:1 Randomization Inoperable defined as risk of death or serious irreversible morbidity of AVR as assessed by cardiologist and two surgeons exceeding 50%. TF TAVR n = 179 VS Standard Therapy n = 179 Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Primary endpoint evaluated when all patients reached one year follow-up. After primary endpoint analysis reached, patients were allowed to cross-over to TAVR.

2 YEAR RESULTS NUMBER NEEDED TO TREAT = 5

All-Cause Mortality (%) AT 5 YEARS Standard Rx (n = 179) TAVR (n = 179) 80.9% 87.5% 93.6% 68.0% 50.8% 64.1% 71.8% 53.9% 43.0% 30.7% HR [95% CI] = 0.50 [0.39, 0.65] p (log rank) < 0.0001 Months * In an age and gender matched US population without comorbidities, the mortality at 5 years is 40.5%.

Subgroup Analysis TEXT All-Cause Mortality Hazard Ratio [95% CI] Overall (N=358) 0.50 [0.39-0.65] Age < 85 (N=186) 0.46 [0.33-0.66] Age 85 (N=172) 0.56 [0.39-0.79] Male (N=166) 0.46 [0.32-0.66] Female (N=192) 0.55 [0.40-0.78] BMI 25 (N=170) 0.58 [0.41-0.84] BMI > 25 (N=188) 0.44 [0.31-0.63] STS 11 (N=170) 0.52 [0.36-0.76] STS > 11 (N=187) 0.53 [0.37-0.74] EF 55 (N=173) 0.47 [0.33-0.67] EF > 55 (N=171) 0.61 [0.42-0.88] Pulmonary Hypertension No (N=136) 0.56 [0.37-0.85] Yes (N=103) 0.51 [0.32-0.82] Mod / Sev MR No (N=261) 0.58 [0.43-0.77] Yes (N=77) 0.30 [0.17-0.53] Oxygen Dependent COPD No (N=270) 0.46 [0.35-0.62] Yes (N=88) 0.68 [0.42-1.10] Prior CABG or PCI No (N=182) 0.55 [0.39-0.78] Yes (N=176) 0.46 [0.32-0.66] Interaction p-value 0.40 0.34 0.71 0.65 0.09 0.87 0.03 0.14 0.27

PARTNER A: TAVI VS SURGICAL AVR (SAVR)

2 years

RESULTS AT 5 YEARS:

RESULTS AT 5 YEARS: TF COHORT

EVOLUTION OF TAVI Cribier-Edwards SAPIEN SAPIEN XT SAPIEN 3 2002 2006 2009 2013 * Sheath compatibility for a 23 mm valve

The PARTNER II S3 Trial Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT by Heart Valve Team n = 1076 Patients Intermediate Risk Operable (PII S3i) SAPIEN 3 2 Single Arm Non-Randomized Historical-Controlled Studies High Risk Operable / Inoperable (PII S3HR) n = 583 Patients ASSESSMENT: Optimal Valve Delivery Access PII A SAVR PI A SAPIEN ASSESSMENT: Optimal Valve Delivery Access Transfemoral (TF) Transapical / Transaortic (TA/TAo) Transfemoral (TF) Transapical / Transaortic (TA/TAo) TF TAVR SAPIEN 3 TAA TAVR SAPIEN 3 TF TAVR SAPIEN 3 TAA TAVR SAPIEN 3

TAVI @ 2YRS EQUIVA LENT (TF BETTER

PARAVALVULAR LEAK IS BAD

TEXT

Moderate/Severe PVL at 30 Days Edwards SAPIEN Valves PARTNER I and II Trials SAPIEN SAPIEN XT SAPIEN 3

TEXT

CURRENT COMMISSIONING GUIDELINES

WHO GETS A TAVI IN 2016? Inoperable patients High surgical risk (including): Patent LIMA graft valve:valve - degenerative bioprosthesis Co-morbidities - obesity, steroid dependancy, COPD etc etc

WHO DOESN T GET A TAVI? Severity of co-morbid conditions Cancer Dementia (at any age) >1 significant (life limiting) co-morbidity >age 90

TAVI AT UHS CURREN T STATE

UHS TAVI PROGRAMME No. TAVI/Year 125 100 100 75 50 commissioning 68 25 29 39 0 11 10 7 7 2008 2010 2012 2014 2016

2016

MDT DISCUSSION turndown decline accept 200 154 134 160 45% 120 95 51% 80 67 41% 40 52 13% 43% 0 2012 2013 2014 2015 2016

MR MG 56 yr old male Previous Hx of Hodgkins lymphoma (aged 18) Treated with high dose RadioTx - 1970s PMHx - Asthma (treated with inhalers) Dx 2 yrs ago Presented worsening SOB (dragging rowing boat up beach!) GP - identified murmer - referred for TTE

TTE Severe AS - peak gradient 90mmHg, valve area 0.75cm2 Moderate MS - mean gradient 3-4mmHg, no significant PHT, (estimated RVSP 25mmHg) Normal LV and RV function Referred to UHS for ongoing assessment - listed directly for angio & clinical RV on day

DIAGNOSTIC ANGIOGRAM

1. PCI WITH ROTABLATIO N TO RCA 2. TF TAVI

MANY THANKS QUESTIONS?