Everest IIDiscussion with Surgeons

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Percutaneous Valve Intervention
Frederick St.Goar, M.D.
Cardiovascular Institute Mountain View, CA
Heart Vascular Symposium June 25th,
2005
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In-Hospital Death Rates for Cardiology Procedures
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Aortic Balloon Valvuloplasty

• Popularized in the 1980s
• Good acute results with low complications
• - gradient reduced 60 to 30 mm Hg
• - valve area increased 0.6 cm2 to 0.9cm2
• Poor durability
• - 65 one yr survival
• - 40 freedom from death, AVR, or repeat BAV at
  1 yr
• - 25 event free survival at 2 yrs

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Aortic Balloon Valvuloplasty

• Only Class IIa or IIb recommended indications
• - a bridge to aortic valve replacement
• - pallation in patients with comorbid
  conditions
• - before urgent non cardiac surgery
• Not recommended as an alternative to AVR in
  adult AS

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Percutaneous Aortic Valve Replacement
Outstanding Issues

• Valve embolization
• Paravalvular leaks
• MV tears
• Access issues
• Control of valve during implantation

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Percutaneous Aortic Valve Replacement
REVIVAL Trial

• Patients with AVA lt 0.7cm2
• BAV
• Randomized
• Perc AVR Standard
  care

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Mitral Valve Regurgitation Percutaneous Repair

Overview
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Mitral RegurgitationRepair vs Replacement
68
Overallsurvival()
Expected
52
Replacement
Years
Serano Circulation
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Percutaneous Treatment of Mitral Regurgitation

• Coronary Sinus Annuloplasty Approaches
• Take advantage of proximity of CS to
  annulus and
• ease of access
• Companies
• MitraLife (ev3)
• Cardiac Dimensions
• Viacor
• Edwards (JoMed)

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Percutaneous Treatment of Mitral Regurgitation

• Issues with CS approach
• Ability to reduce annulus (CS over LA)
• Mitral annular calcification?
• Potential pinching of circumflex coronary artery
• Risk of CS thrombosis/occlusion
• Risk of CS erosion/perforation over long term
• Very congested IP space
• If it works, however, this approach would be
  simple and practical for many interventional
  cardiologists

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Percutaneous Treatment of Mitral Regurgitation
Non Sinus Approach

• QuantumCor - Shrinkage with RF energy
• Annulus dense collagen
• Maximum contraction 60o C (20)
• Repeatable procedure
• Lack of implant
• Overheating disrupts collagen matrix

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Anchor-based Plication of Posterior Annulus
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Current MR Surgical Options Complications,
Mortality, Procedures
MV Procedure Distribution
STS database, 2002 in-hospital data
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Bow - Tie Repair

• gt1000 procedures published
• in peer review journals
• (20-35 without ring
• annuloplasty)
• Degenerative and
• Functional MR
• Overall freedom reop
• gt90 at 3 years

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Potential Patient Benefits of Evalve System

• No stopping of the heart
• No cardiopulmonary bypass
• No thoracotomy/sternotomy
• Proven percutaneous access routes
• Real time MR assessment during procedure
• Ability to reposition and reverse deployment

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Acute Procedural Results EVEREST I

• Early experience (3 of first 7)
• 1 Cleft between P1 and P2
• 2 insufficient MR reduction
• Use of 2 clips not an option
• No procedural MAE
• All underwent elective surgery
• 2 repair
• 1 replacement (intended)

• One clip (20)
• Two clips (4)
• 2 other pts elective surgery prior to DC

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Core Lab MR Results 30 days
MR Severity Grade
All patients discharged w Clip
Excluding each PIs 1st 2nd roll-ins
(n 22) (n 11)
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Patients Discharged with a Clip One Month MR
Results (Core Lab) n 22
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Patients Discharged with a Clip MR 2 at One
Month was Maintained at 6 Months in 93 of
Patients
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Summary Conclusions Edge-to-Edge repair with
MitraClip

• Low MAE and complication rates
• Feasible to reduce MR to ? 2
• Ability to reduce MR increasing with experience
• Maintenance of MR reduction at 6 months is
  promising
• Controlled procedure
• Procedure time decreasing with experience
• Surgical options preserved

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Summary Conclusions Edge-to-Edge repair with
MitraClip

• Further study of this promising technique
  in a phase 2 trial is warranted
• EVEREST II

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EVEREST II Study Design

• Prospective, randomized, multi-center study
• Control surgical mitral valve repair or
  replacement
• Patients randomized 21
• 30 centers in US
• Primary Effectiveness Endpoint
• Freedom from surgery for Valve Dysfunction,
  death, and moderate to severe (3) or severe (4)
  mitral regurgitation at 12 months.
• Primary Safety Endpoint
• Freedom from MAE at one month

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Percutaneous Valve Intervention Summary

• At least 150,000-200,000 pts either too sick
  for AVR,
  or too sick/not sick enough for MVR.
• Reasonably safe and effective percutaneous
  procedures will substantially enhance pt quality
  of live.
• Devices are in early stages of development, but
  even now are promising.
• Regulatory and clinical trial strategies are
  evolving.

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Percutaneous Valve Intervention
Summary

• Direct comparison / randomized trials with open
  valve surgery are mandatory.
• Progress will be made only through close
  collaboration
• - Cardiac Surgeons know valves
• - Interventional Cardiologists catheters
• - Echocardiographers / Imagers
• - Engineers know how to make things
• - Regulators know what can get
  approved and how