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Structural Heart Disease Update

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Presentation on theme: "Structural Heart Disease Update"— Presentation transcript:

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2 Structural Heart Disease Update
Michael Sumners, DO Structural Heart Disease Update

3 Disclosures

4 Topics TAVR update: Durability Mitral Valve disease
2017 Valve update Mitral Valve disease ASD / PFO Closure data Corevalve for valve-in-valve disease approval for high/extreme risk. 2015 Europe corevalve and sapien approved

5 795,000 in the US with new or recurrent CVA each year.
25% end up with dx cryptogenic cause

6 Cryptogenic stroke Atrial fibrillation Hypercoagulable state
Autoimmune or inflammatory vasculitides Aortic arch plaque Paradoxical embolus ASD, VSD, PFO,

7 PFO is common in the general population, 25-30%
PFO does not increase the risk of stroke In those with cryptogenic CVA, it is observed more frequently, up to 50% Haeusler KG, Herm J, Hoppe B et al. Thrombophilia screening in young patients with cryptogenic stroke. Prevalence of gene polymorphisms compared to healthy blood donors and impact on secondary stroke prevention. Hamostaseologie. 2012;32(2):147-52

8 Pre 2014. Whether to close PFO to reduce risk of recurrent ischemic stroke Open question for decades Trials with slow enrollment CLOSURE 1: Closure not superior to medical therapy RESPECT: At 3 years, no statistical difference in recurrent stroke rate, although cited as 50% reduction**

9 RESPECT NEJM Sept 14. FDA Approval:
980 patients. Mean age 46. 6yr follow up. PFO and cryptogenic CVA ITT vs As treated analysis Dropout rate 600 at 5 years, 30 at 10 years. FDA Approval: Despite the overall low incidence of recurrent stroke and nonsignificant findings suggesting effectiveness, preventing recurrent stroke is of high value.

10 CLOSE 663 patients with cryptogenic CVA and atrial aneurysm or large shunt 3 treatment groups at 1:1:1 ratio PFO closure + antiplatelet therapy Antiplatelet therapy alone Oral anticoagulation Mean 5.3yr follow up

11 REDUCE NEJM sept 14/2017 Supplementary appendix
664 patients. Mean age 45. Cryptogenic CVA 2:1 ratio. PFO closure + antiplatelet vs. antiplatelet therapy. Clinical ischemic CVA and silent infarction detected at 24 mo MRI 6/441 in Closure group (1.4%) 12/223 in medical therapy group (5.4%) AF more common in closure group 6.6% vs. 0.4% NNT to prevent 1 cva at 24 mo was 28 Limited by: Study device not implanted in 28 patients. Option for medical therapy arm to have closure outside of trial. Supplementary appendix

12 Trans-esophageal echo Rhythm monitoring
Brain MRI / CT Rule out lacunar stroke or non cva lesions Trans-esophageal echo Intracardiac source or aortic atheroma Rhythm monitoring Workup for hypercoagulable state Typically Anticardiolipin / hyperhomocysteine

13 Final Thoughts on PFO Closure
Defining the population to benefit Atrial septal aneurysm Moderate to large shunt Is a stroke in someone with a PFO and an aneurysmal or moderate to large shunt still considered cryptogenic? What is the longer term AF risk?

14 Pre 2014 CLOSURE 1 PC RESPECT AHA/ASA Class 3 recommendation for PFO closure AA Neurology: Recommended against closure in routine settings unless recurrent cryptogenic CVA

15 RoPE Score Age Cortical stroke Diabetes Hypertension Smoking
Prior CVA or TIA Young patients with superficial stroke and no vascular disease risk factors

16 Timeline comparison

17 AS / TAVR

18 Epidemiology Valvular heart disease accounts for % of cardiac surgical procedures. Two-thirds of heart valve operations are for aortic valve replacement The most common reason for AVR is bicuspid aortic valve. Mitral valve surgery is most often performed for MR AVR, most commonly AS.

19 Natural History of Aortic Stenosis
Sclerosis Valve calcification with velocity <2.5m/sec Progression to severe AS 10% at 5 years. Once moderate disease is detected Increase in mean gradient 7 mmHg/yr Decrease in valve area of 0.1 cm^2/yr Increase velocity of 0.3 m/sec/yr

20 Aortic Stenosis Not a Passive Disease Process Risk Factors
Active lipid deposition Inflammation Neo-angiogenesis Calcification Risk Factors Male, diabetes, dyslipidemia Metabolic syndrome, smoking

21 Epidemiology Worldwide rheumatic fever is the most common cause of valve disease In industrialized areas, valvular disease of “old age” predominates Calcific aortic stenosis Functional Mitral Regurgitation

22 Valvular Disease is Under-detected
Post-mortem studies show approximately 50% of aortic stenosis is identified before death. When we find undiagnosed valve disease with complications it is commonly associated with perioperative and maternal deaths.

23 Aortic Stenosis – Medical therapy
Treat Hypertension Vasodilators Statins - Class 3 Vasodilators – Generally need hemodynamic monitoring for monitoring changes in SVR and cardiac output. Dropping SVR may acutely reduce CO, in some individuals it may increase.

24 TAVR US FDA approval in 2011 Over 50,000 procedures
Survival, symptom status, quality of life

25 TAVR History: Extreme Risk High Risk 2014 2015
Higher rate of survival with TAVR at 2 years

26 2017 Guideline changes High or prohibitive risk: B to A. Class 1
Mean life expectancy 11 mo to 30 mo Intermediate risk : 2A PARTNER 2A. SURTAVI: Published after guideline release Lower risk group than PARTNER 2A Risk of stroke was lower with TAVR AI and pacemaker need were higher. 80% of SAVR procedures are low risk pts

27 Valve in Valve Failed prior bioprosthetic valves

28 TAVR – The Current State and What is Next?
Ongoing: PARTNER 2A SURTAVI : RESULTS*** Next: PARTNER III – Low risk Sapien 3 trial. FDA Approved

29 NOTION trial – Low risk

30 PARTNER 3 1300 severe AS patients STS low risk 3%.
SAVR vs. TAVR with Sapien 3 valve Primary endpoint 12 mo all cause mortality, stroke and rehospitalization. Followed for 10 years. Results around Fall 2019.

31 Natural history / clinical course is variable
40-50% is asymptomatic. Natural history / clinical course is variable 5-6% undergo treadmill stress due to fear of testing risk. EARLY-TAVR Trial 1100 patients. Severe Asymptomatic AS Started enrolling March 2017.

32 Durability Subclinical leaflet thrombosis Raj R Makkar ACC 17
TAVR 12 %, SAVR 4 % Postulated mechanism for structural deterioration Ongoing CT substudies to investigate.

33 Vascular Complications
20Fr to 14Fr.

34 Durability EuroPCR 2017 2343 patients. 0.2 to 1.5%
Avg 22 months, out to 9 years. 3-4 years for low and intermediate risk data 5 year performance of the Corevalve from ADVANCE study 996 patients: 5 year mortality 50%. Mean gradient and valve area did not change over time.

35 Durability For the followed cohort to date, 5 year mortality is high and appears to be unrelated to valve complications. As intermediate and low risk patients are followed longer more durability data will be available.

36 Asymptomatic Severe Aortic Stenosis
Which patients with asymptomatic severe aortic stenosis should be considered for intervention. EF < 50 Already undergoing cardiac surgery Velocity >5m/sec, Mean gradient >60, low risk Abnormal Exercise Treadmill Fast progression on echo >0.3m/s/yr Changes from 2008.

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38 2012 ESC valve guidelines

39 Major Changes to the Guideline
Restructured to help determine timing of interventions Transcatheter therapies Recommendations for use of heart valve team

40 2014 2008 Update ABCD Helps to determine Timing of intervention
Assess risk Severity of Valve Lesion Symptoms Response of LV and RV

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42 Left Sided Valve Disease
Endovascular Therapy: TAVR, Mitraclip Mixed Valve Disease Prosthetic Valve Considerations

43 The Simvastatin and Ezetemibe in Aortic Stenosis Trial (SEAS)
Randomized double blind: pts Simvastatin + Zetia or Placebo Mild – Moderate Aortic Stenosis Followed for average of 52 months No difference in rate of AVR or hemodynamic progression

44 Aortic Stenosis – Timing of Intervention

45 3815 Consecutive patients from registry data with severe AS
: 3815 Consecutive patients from registry data with severe AS 300 Initial surgical Conservative 5 yr All cause death and HF hospitalization 15% - Initial surgical 26% - Conservative Published december 2015.

46 TAVR >50% risk of death or major morbidity at 1 year with surgery
Disease affecting 3 major organ systems Anatomic factors that increase risk of surgery

47 STS Scoring Summary

48 Mitral Regurgitation Primary (Degenerative) Secondary (Functional)
Correction of MR curative Mitral Prolapse Secondary (Functional) LV dysfunction

49 Mitral Regurgitation Benefits of Mitral Repair vs. Replacement
Lower operative mortality LV Function is better preserved Risks with anticoagulation Valve degeneration

50 Mitraclip EVEREST II Trial Reduced MR Improved symptoms LV remodeling

51 Bicuspid Aortic Valve Prevalence of 0.5-2% 70-80% of cases are male
Should be considered a general thoracic aortopathy. CT or MRA

52 Bicuspid Aortic Valve Aortopathy
No medical therapy has proven to reduce the rate of progression of aortopathy associated with a bicuspid valve. >4.5cm at least annual evaluation

53 Bicuspid Aortic Valve Aortopathy
>4.5 cm: 5-5.5 cm: >5.5cm:

54 Aortic Insufficiency Medical Treatment

55 Aortic Insufficiency: AVR
Symptomatic LV Dysfunction Undergoing surgery LV Dilation

56 Mitral Stenosis Natural history:
Rate of progression is highly variable. Avg rate of decrease in area of 0.1cm

57 Review Treatment for valve disease is becoming progressively more complex with increasing treatment options and a heart team approach is recommended for complex decisions.

58 Review Trans-catheter treatments for valve disease with TAVR or Mitra-clip are becoming more common and ongoing trials assessing utility in lower risk patients are ongoing.

59 References Eikelboom JW, Connolly SJ, Brueckmann M, et al. Dabigatran versus Warfarin in Patients with Mechanical Heart Valves. NEJM 2013; 369: Makkar RR, Fontana GP, Jilaihawi H, et al. Transcatheter Aortic-Valve Replacement for Inoperable Severe Aortic Stenosis. NEJM 2012; 366: Mauri L, Foster E, Glower DD et al. 4-Year Results of a Randomized Controlled Trial of Percutaneous Repair Versus Surgery for Mitral Regurgitation. JACC 2013;62: Nishimura RA, Carabello BA, Faxon DP, et al Focused Update Incorporated into the ACC/AHA Guidelines for the Management of Patients with Valvular Heart Disease. Circulation 2008;118:e Nishimura RA, Otto CM, Bonow RO, et al AHA/ACC Guideline for the Management of Patients with Valvular Heart Disease. JACC 2014; 63: e57-185 Reardon MJ, Adams DH, Kleiman NS, et al. 2-Year Outcomes in Patients Undergoing Surgical or Self- Expanding Transcatheter Aortic Valve Replacement. JACC 2015; 66: Rossebo AB, Pedersen TR, Boman K, et al. Intensive Lipid Lowering with Simvastatin and Ezetimibe in Aortic Stenosis. NEJM 2008; 359: Tadros TM, Klein MD, Shapira OM. Ascending Aortic Dilatation Associated with Bicuspid Aortic Valve: Pathophysiology, Molecular Biology and Clinical Implications. Circulation 2009; 119: Taniguchi T, Morimoto T, Shiomi H, et al. Initial Surgical Versus Conservative Strategies in Patients with Asymptomatic Severe Aortic Stenosis. JACC 2015;66:

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62 Mixed Valve Disease 64yo M presents to establish care after not having a physician for the past 10 years. Reports slowly progressive exertional fatigue for the past 6 months. Echo Moderate mitral regurgitation. Moderate mitral stenosis.

63 Mixed Valve Disease Symptoms and routine treatment follow the predominant lesion Require more frequent evaluation than isolated disease of the same severity May require intervention despite the lack of ‘severe quantification’

64 Prosthetic Valves Mechanical or Bio-prosthetic
How long will a bio-prosthetic valve last Inversely related to age. Deterioration rate at years 10% if age 70 90% if age 20 Individualized decision.

65 Prosthetic Valves Anticoagulation Mechanical:
Thrombogenicity and alteration of flow. Aortic Valve goal INR 2.5 if low risk. Mitral Valve or AVR with higher risk goal INR 3.0. ASA 81mg for all. ReAlign trial stopped prematurely due to increased thromboembolic events.

66 Mechanical Valve Anticoagulation
Mechanical Aortic INR 2-3 Aortic Additional Risk INR Mitral INR

67 Mechanical Valve Bridging Anticoagulation
Atrial Fibrillation Prior VTE Hypercoagulable Older Mechanical Valve EF < 30 >1 Mechanical Valve

68 Mild: 3-5 years Moderate: 1-2 years Severe: 6mo to 1 year
Re-iterate the natural progression of AS and of bicuspid aortic valve stenosis. Natural history progression of mitral stenosis. Is there a natural history of MR.

69 Review Patients with mixed valve disease of moderate severity requires closer follow- up and may require intervention despite lack of ‘severe’ quantification.

70 Review Bicuspid Aortic Valve should be considered a global thoracic aortopathy and imaged in its entirety with routine follow up.

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73 Aortic Stenosis – Low-flow low-gradient
Dose Ao velocity Gradient Area Lvef EAE / ASE guidelines Velocity >4m/s with Area <1.0cm2.

74 3 Outcomes 1 - Severe Aortic Stenosis 2 - Moderate Aortic Stenosis
3 - Lack of contractile or flow reserve Failure to increase stroke volume by >20% Poor prognosis with medical or surgical tx.

75 Pregnancy and Valvular Heart Disease

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78 TAVR for Aortic Insufficiency

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80 Prosthetic Valves Dysfunction New or louder murmur Hemolysis
Thrombosis Pannus Endocarditis

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82 How is risk determined?

83 Fellow MR TAVR AI Aortic Stenosis TR MS Testing

84 Aortic Insufficiency Testing


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