UPDATE ON TAVR, MITRACLIP, AND EMERGING
STRUCTURAL INTERVENTIONS
20th Annual SD Heart Failure Symposium
1/11/2020
Ryan Reeves, MD, FACC, FSCAI
Structural Interventions: The Big Two
• Symptomatic severe AS is associated with a high mortality and only valve replacement improves survival.
• With a comprehensive work-up for procedural planning, TAVR:
– improves survival at one year in inoperable patients.
– is feasible and comparable to SAVR in low, intermediate, and high-risk patients and approved for surgical valve failure.
– complications have decreased with device improvements.
– is associated with shorter procedure times, hospital times, and time to recovery compared to SAVR.
Percutaneous Mitral Valve Repair• MitraClip is an edge to edge repair technique that may significantly reduce
mitral regurgitation through venous access, trans-septal puncture, and guidance by trans-esophageal echocardiography that is approved for degenerative and functional MR.
• If the procedure is successful, outcomes are comparable to surgical repair, but the rate of a successful repair is lower than standard surgery.
Transcatheter Aortic Valve Replacement
Operative Risk• Overall AVR operative mortality is 4% (STS Risk Score)
• Comorbidities increase risk from 4-45% and are increasing
Korfer R, et al. J Heart Valve Dis 1995. 4 Suppl 2: 194-7.Connolly HM, et al. Circulation 2000 101(16)1940-6.Powell DE, et al. Arch Int Med 2000 160(9) 1337-41.Iung and Vahanian. Heart 2012;98,iv7-iv13.
• Elderly, COPD, advanced NYHA class, atrial fibrillation, concomitant CABG, severely reduced LV systolic function, prior MI, CAD, height, weight, renal dysfunction, etc.
46%28%28%
41%
Percentage of comorbidities in PARTNER trial, Cohort B,2010
22%
Frailty• Comprehensive Assessment of Frailty
– Weakness (grip strength), self-reported exhaustion, gait speed, IADL (chores, activities, etc), balance and body control (positions, put on and remove a jacket, turn 360 degrees, etc), albumin, creat, BNP, FEV1
Sundermann, et al. Eur J of Cardiac Surgery, 2011;39:33-37.
30-40% of patients with severe aortic stenosiswere NOT being offered surgery due tocomorbidities!
TAVR Trials for FDA and CMS Approval
• Prospective, Randomized-Controlled, multi-center trials
• Determine the safety and effectiveness of thedevice and delivery systems in: inoperable high risk intermediate risk low risk,symptomatic patients with severe aorticstenosis.
• Major cardiovascular outcomes, secondaryoutcomes, long-term follow-up
High Surgical Risk - 2011
Intermediate Surgical Risk - 2016
Inoperable - 2010
Low Surgical Risk - 2019
PARTNER Trial Results
Low Surgical Risk - 2019
Inoperable - 2014 High Surgical Risk - 2014
Intermediate Surgical Risk - 2016
Core/EvolutValve Trial
Results
At 1 year, a paired analysis of the distance covered during a 6-minute walk test showed that there was significant improvement after TAVR (P = 0.002) and no change after standard therapy (P = 0.67).
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Low risk functional data
Baron et al. JACC 2019
Kansas City Cardiomyopathy Questionnaire- Overall SummaryProportion of Patients Achieving Specific Levels of Change
Vascular trauma
Stroke and TIAParavalvular
Aortic Regurgitation
Heart Block
Early trials Increases risk of mortality
Higher total rate than SAVR, but similar stroke rates
Increases risk of mortality
Pacemaker requirement (only with Core Valve)
Why? Large delivery systems & diseased vasculature
Ascending aortic disease and crushing a thick, native aortic valve
Using a round balloon or placing a round valve in an irregularly shaped orifice, undersizing, poor deployment
Exerting pressure on the left ventricular outflow tract with valve deployment, pre-existing conduction disease
Response (operators and industry)
Smaller equipment and operator experience
Smaller equipment, more maneuverabledelivery catheters, better planning, less inflations across the valve
Better pre-procedural planning with CT scans, oversizing, skirt around the valve, inflation after valve placement, easier deployment
Repositionable,easier deployment, shorter frame extension into LVOT
Contemporarytrials
Reduced vascularcomplications by > 50%
At least equivalent to and trending lower than SAVR
Reduced 60-80% Reduced pacemaker implantations by 40-50%
TAVR Complications update
0.0%
1.0%
2.0%
3.0%
4.0%
5.0%
6.0%
7.0%
P1B(TF) P1A P2B (TF) P2BXT(TF) S3HR S3IR P3
6.3%
5.2%
4.5%
3.5%
2.2%
1.1%
0.4%
All Cause Mortality at 30 Days
TAVR Over Time
0.0%
1.0%
2.0%
3.0%
4.0%
5.0%
6.0%
7.0%
P1B(TF) P1A P2B (TF) P2BXT(TF) S3HR S3IR P3
6.7%
5.6%
4.1%4.3%
1.5%
2.6%
0.6%
All Strokes at 30 Days in TAVR Patients
TAVR Over Time
0%
5%
10%
15%
20%
25%
P1B(TF) P1A P2B (TF) P2BXT(TF) S3HR S3IR P3
12%11.5%
16.9%
24.2%
2.9%
4.2%
0.8%
Moderate/Severe Paravalvular Leak at 30 days
TAVR Over Time
Edwards S3 Valve
Core Valve: self-expanding, nitinol frame, porcine pericardium leaflets; 23, 26, 29, and 31mm valves (and as of three weeks ago, 34mm)
Core Valve
CT scan based measurements include:
• Aortic annular area and perimeter
• LVOT and aortic diameters
• Height of coronary artery ostia
• Artery size and tortuosity
CT scan based measurements include:
• Aortic annular area and perimeter
• LVOT and aortic diameters
• Height of coronary artery ostia
• Artery size and tortuosity
CT scan based measurements include:
• Aortic annular area and perimeter
• LVOT and aortic diameters
• Height of coronary artery ostia
• Artery size and tortuosity
CT scan based measurements:Artery size and tortuosity
CT scan based measurements:Artery size and tortuosity
CT scan based measurements:Artery size and tortuosity
Sapien 3 Deployment
Temporary pacemaker in RV
CoreValveNitinol – ‘memory metal’
Percutaneous Mitral Valve Repair
• Degenerative MR affects up to 600,000 persons in the US, some of which areconsidered at prohibitive risk for standard surgical intervention.
• The MitraClip percutaneous mitral valve repair system was approved inOctober 2013 for use in symptomatic patients with 3+ or worse degenerativeMR at prohibitive risk for surgery after the EVEREST trial.
• The COAPT trial published in 2018 showed that after optimization of medicaltherapy, patients with functional MR had improved outcomes with MitraCliptherapy.
Alegria-Barrero et al. Eurointervention 2012.
Percutaneous Mitral Valve Repair
Percutaneous Mitral Valve Repair
Percutaneous Mitral Valve Repair
Percutaneous Mitral Valve Repair
Reduction of mitral regurgitation from moderate-severe to mild with one MitraClip device.
Percutaneous Mitral Valve Repair
EVEREST IIRepeat Surgical Intervention
Feldman et al. J Am Coll Cardiol, 2015.
Functional MR Trials
Major Inclusion Criteria
Severe secondary MR
Regurgitant Volume >30mLOr ERO >20mm2
EF 15-40%
NYHA ≥II
Heart failure hospitalization within 1 year
Investigator determined optimal MT
Not surgical candidate
Major Inclusion Criteria
Secondary 3+/4+ MR
Optimal therapy for CAD, CHF, LV dysfunction, MR
EF 20-50%, LVED ≤ 70mm
NYHA ≥II
Heart failure hospitalization within 1 year or BNP≥300
MitraClip feasible
Not surgical candidate
MITRA-FR• 2013-2017, France,
307 patients randomized
COAPT• 2012-2017, US/Canada,
614 patients randomized
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MITRA-FR: more Implantation Failure and more device group
events and less MT events
COAPT NNT to prevent one hospitalization = 3.1 and to
save one life = 5.9.
LV End-Diastolic Volume and EROA Ratio Further Defines MR
Packer and Grayburn. JACC Heart Failure 2019
Percutaneous Tricuspid Repair (US off label)
Propensity matched registry patients
LA-RA shunting Systolic or Diastolic Heart Failure
• Theory: decrease pulmonary congestion by relieving excess left atrial volume and pressure
• Small trials have shown a decrease in pressure with exercise but an improvement in functional status has yet to be seen.
Guimares et al. Eurointervention 2019
Other Structural Interventions• Left Atrial Appendage Occlusion
– Stroke Prevention in Atrial Fibrillation patients at high-risk for bleeding
• Pulmonary Valve Reugurgitation or Stenosis:– Melody or Edwards valve placement (More in development)
• Mitral Stenosis: – Percutaneous Balloon Mitral Valvotomy (acceptable durability)
• Atrial Septal Defect:– Secundum: Closure up to 36mm in diameter despite deficient
rims; fenestrated if RV failure– Sinus Venosus Defect: creative percutaneous procedures are
possible
• Persistent Ductus Arteriosus– Percutaneous Closure Thank ou
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