An Overview of Mainstream Structural Heart Therapies: TAVR/MitraClip/Watchman

Transcription

1 An Overview of Mainstream Structural Heart Therapies: TAVR/MitraClip/Watchman Yakima Valley Medical Conference Moses Mathur MD MSc March 2018

2 Outline CC : 85 yo M w/ Shortness of breath TTE : Cardiomyopathy Severe aortic stenosis Severe mitral regurgitation +/- Atrial fibrillation CHF Review (who/when/why/how): TAVR MitraClip Watchman

3 Aortic Stenosis (AS)

4 Common causes of AS Common causes of AS

5 The US population is aging Age 65+ Prevalence of severe AS in elderly ~ 3.4% ~75% have Sx Age 85+ Osnabrugge et al. JACC 2013

6 AS - Prognosis after Sx onset E. Braunwald, On the Natural History of Severe Aortic Stenosis, Journal of the American College of Cardiology, Vol. 15, No. 5, 1990, pp

7 Earlier Tx = Better Mortality Genereux et al., EHJ 2017

8 Evaluation of Aortic Stenosis History and Physical examination TTE (class I, B) Invasive hemodynamics for inconclusive or discordant data (class I, C) Exercise testing reasonable to unmask asymptomatic disease (class IIa, B)

9 TAVR vs SAVR? Depends on overall surgical risk assessment Evaluation by Heart team is key (Class I, C) CTA (TAVR), PFTs, Echo, H&P STS score:

10 Two major TAVR valves in U.S Edwards-Sapien S3 Balloon-expandable CoCr Frame + Bovine Pericardium Outer sealing skirt Not repositionable Medtronic Corevalve Evolut-R Self-expanding Nitinol Frame + Porcine tissue Extended skirt / (Sealing skirt in Pro) Repositionable

11 Balloon expandable (Sapien S3)

12 Self-expanding (Corevalve)

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15 TAVR : Supportive innovations Cerebral protection devices Sheath design Vascular closure systems

16 Mortality (30 day) Improving operator experience Better patient selection Improved device design Improved implantation strategies

17 Post-TAVR Expectations At VM: ASA 81 daily, Plavix 75 (x 3 months) Afib: Warfarin only (goal INR 2-3) Afib + CAD (stents): Plavix, Warfarin Moderate sedation, discharge in 2-3 days

18 Mitral Regurgitation (MR) repair with MitraClip

19 Mitral Regurgitation (MR) Most common valve disease in the US (compared to ~1/20 affected by aortic valve disease) 1.Lloyd-Jones D, Adams RJ, Brown TM, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics 2010 update: a report from the American Heart Association. Circulation. 2010;121(7):e46-e Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):

20 MR progresses to heart failure Nearly half considered not fit for surgery: Advanced age Impaired EF Multiple comorbidities 1.Grigioni F, Tribouilloy C, Avierinos JF, et al; MIDA Investigators. Outcomes in mitral regurgitation due to flail leaflets: a multicenter European study. JACC Cardiovasc Imaging. 2008;1(2): Enriquez-Sarano M, Avierinos JF, Messika-Zeitoun D, et al. Quantitative determinants of the outcome of asymptomatic mitral regurgitation. N Engl J Med. 2005;352(9): Cioffi G, Tarantini L, De Feo S, et al. Functional mitral regurgitation predicts 1-year mortality in elderly patients with systolic chronic heart failure. Eur J Heart Fail. 2005;7(7): Rankin et al. J of Thoracic and Cardiovascular Surgery. March 2006.

21 MitraClip the percutaneous Alfieri stitch

22 Chronic MR DMR Prolapse DMR Flail Normal Mitral Valve FMR Primary (Degenerative) Diseased valve structure (leaflets, chords, papillary muscles, annulus) MR is the disease Etiologies: MVP, Barlow s valve (myxomatous degeneration), CTD, IE, Rheumatic, cleft mitral valve, radiation Secondary (Functional) Valve structure usually normal MR caused by LV distortion Etiologies: Ischemic CMP, Non-CMP

23 HEART TEAM DECIDES IF OPTIMAL FOR MITRACLIP A Heart Team will determine final MitraClip eligibility, assess surgical risk, and verify that existing comorbidities do not preclude expected benefit of MR reduction. Reference: 1. MitraClip Clip Delivery System Instructions for Use.

24 MitraClip Device (Implant) Cobalt chromium construction MRI safe up to 3T MRI magnet Polyester cover designed to promote tissue growth

25 Patient / Procedural Considerations Patient will need intubation, general anesthesia 24-Fr (8mm) Steerable Guide in femoral vein Trans-septal puncture Heparin during procedure TEE support during procedure Post-procedure: ASA 81mg daily, Plavix 75 x 30d

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27 What the sub-valvular apparatus actually looks like A1 A2 A3 Pre-procedure TEE helps identify case feasibility and challenges

28 82 yo M w/ COPD, Afib, HTN, CKD III, presenting with CHF exacerbation. Felt to be poor surgical candidate due to co-morbidities and frailty.

29 Echo imaging is key to success in complex structural cases

30 Positioning

31 Clip deployed Unfortunately, still >moderate MR

32 Second clip deployed Mild residual MR

33 N=279, STS~5% Surgical repair was more effective than clip Clip was safer than surgery: Implant success (89%) No procedural deaths Low rate of urgent procedural complications

34 EVEREST-II (5 year data) Sustained reduction in 3+/4+ MR and severe heart failure symptoms. Improvements in LV volumes and dimensions 5 year

35 MitraClip in Prohibitive Risk Pts Mean age 82y, STS 13% Implant success 95.3% Mean hospital stay was 2.9 ± 3.1 days Majority discharged to home The majority of surviving patients at 1 Year (82.9%) remained MR 2+ at 1 year, and 86.9% were in NYHA I or II QOL scores improved and hospitalizations for heart failure reduced in patients whose MR was reduced. Lim et al JACC Vol. 64 No

36 Adverse events (TVT 2016)

37 Watchman LAA Occlusion

38 AFib is a Growing Problem Associated with Greater Morbidity and Mortality AF = most common cardiac arrhythmia, and growing 5M 12M AF increases risk of stroke < Higher stroke risk for older patients and those with prior stroke or TIA 15-20% of all strokes are AFrelated ~5 M people with AF in U.S., expected to more than double by x greater risk of stroke with AF 2 AF results in greater disability compared to non-af-related stroke High mortality and stroke recurrence rate 1. Go AS. et al, Heart Disease and Stroke Statistics 2013 Update: A Report From the American Heart Association. Circulation. 2013; 127: e6-e Holmes DR, Atrial Fibrillation and Stroke Management: Present and Future, Seminars in Neurology 2010;30:

39 Ischemic CVA vs. Bleeding CHADSVASC score Annual stroke risk (%) CHADS-VASC: CHF, HTN, Age, DM, Stroke, Vasc, Gender HASBLED score Annual bleeding risk (%) HAS-BLED: HTN, Age, Abnl renal/liver labs, Stroke, Hx major bleeds, Labile INR, Predisposing medications (NSAIDs, Anti-platelets, etc.) CHADSVASC 1 : Oral anticoagulation (OAC) may be considered CHADSVASC 2 : OAC are recommended OAC not always possible : Risk vs Benefit

40 Oral Anticoagulation Not Always Ideal Use of OACs in AF Patients peaks at ~50%, use declines with increasing risk 1. Hsu, J et al. JAMA Cardiol. Published online March 16, doi: /jamacardio

41 OAC compliance is an issue: ~30% of patients stop OAC at 2 years Source: Martinez C, et al. Therapy Persistence in Newly Diagnosed Non-Valvular Atrial Fibrillation Treated with Warfarin or NOAC. A Cohort Study. Thromb Haemost Dec 22;115(1):31-9. doi: /TH

42 Left atrial appendage (LAA) Source of 90% of clots leading to ischemic CVA 1 1. Watson et al. Lancet Watchman Device that occludes the LAA via transseptal approach Alternative to OAC

43 Watchman Device Nitinol frame Self-expands to maintain position in LAA Fixation anchors Engage LAA for additional stability PET cover 160 microns Designed to trap clot in LAA Endothelializes MRI safe (3T)

44 Watchman Patients Non-valvular Afib CHADS 2, CHA 2 DS 2 -VASC 3 (i.e. OAC recommended) Suitable for warfarin (short-term) Have sound clinical rationale to seek alternative to warfarin GI bleeding, Falls/Imbalance, Labile INR, Risk prone jobs (e.g. machinist)

45 Watchman - Procedure Pre Intra Post TEE Assess LAA Thrombus(?) GA TEE-guidance Fem. Vein access (14F, 4.6mm) Trans-septal POD1 TTE Discharge ASA 81, Warfarin f/u TEE (45d)

46 Post-procedure Protocol 92% off warfarin after 45 days (99% at 1 year) Canine Model 30 Day Canine Model 45 Day

47 Clinical Results (Watchman vs Warfarin) Holmes et al., JACC 2015

48 Complication Rates

49 Summary Severe AS, MR and Afib are frequent actors in CHF 1. Severe AS: TAVR now first-line for severe, symptomatic AS (greater than low risk) Earlier referral and treatment = better outcome! Low risk trials are ongoing stay tuned!

50 Summary Severe AS, MR and Afib are frequent actors in CHF 2. Mod-severe, or Severe MR: Symptoms + poor surgical candidate? Think MitraClip! High procedural success Short hospital stay Sustained NYHA/QOL benefit

51 Summary Severe AS, MR and Afib are frequent actors in CHF 3. Atrial fibrillation Think Watchman: Afib (non-valvular) + need OAC (elevated CHADS score) + can t continue OAC long-term (GI bleeding, Falls/Imbalance, Labile INR, etc.) Most patients: Discharged the next day, off warfarin in 45 days.

52 Questions?