Indications for Cardiac Surgery: Kwabena Mawulawde, MD

4/17/2015
Current Concepts in
Cardiovascular Disease
Kwabena Mawulawde, MD, FACS, FACC, FCCP, FAHA
Attending Cardiothoracic Surgeon
New Mexico Heart Institute
4/11/2015
No Disclosure
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4/17/2015
The Left Atrial Appendage: To Ligate or not to Ligate?
• Atrial Fibrillation:
– 1% to 2% of the general population
– Fivefold increase next 40 years
– 5x risk of stroke with than without
– 90% strokes are ischemic
– 15% to 20% associated with AF
• Left atrial appendage
– 90% of detected thrombi AF
– “Our most lethal human attachment” Johnson WD, et.al : Eur J CTS 2000; 17:718
– Left Atrial Appendage Occlusion Study
• Randomized study
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4/17/2015
The LAA and Strokes / US
All Strokes
(100%)
90%
Ischemic
10%
Hemorrhagic
20% are
Associated
with Afib
95% have
LAA Thrombi
=
~130,000 Strokes / yr.
Source; Maze IV Training Course 7/2014 slide deck
Why the LAA and not the RAA…
RAA
1.
2.
LAA
http://medical-dictionary.thefreedictionary.com/Virchow's+triad
Dr. James Cox – LAA Exclusion Rationale (Video)
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4/17/2015
Patients Considered for Mechanical
Closure of LAA
• Interventional Approach
– Watchman, Lariat, Amplatzer plug
• Surgical Approach
Candidates for Closure
• Contraindication to oral anticoagulation (OAC)
• Catheter ablation for AF
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4/17/2015
Candidates for closure
• Cardiac surgical patients Hx of A.Fib.
– 3 Categories: CABG, aortic valve, mitral valve
– 60,000-100,000/annually in USA, OR AF
AATS independent survey questionnaire
-AF ignored by surgeons amid concerns of increase risk
All patients undergoing cardiac surgery
• Perioperative AF: risk of stroke; increase hospitalization; 30 day mortality.
• AHA/ACC/ESC: have recommended surgical LAA closure in cardiac surgical
patients “…who are at high risk for developing post-op AF.”
•
Two thirds of patients will not develop postoperative AF
•
Remaining one third is almost impossible to identify preoperatively.
•
Closure with external clip in all patients?
•
Cost/benefit as a deterrent.
– Perioperative strokes
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4/17/2015
AtriClip Gillinov-Cosgrove LAA Clip
Product Codes: CGC135, CGC140, CGC145, CGC150
510(k) Number: K131107 - 5/14/2013
Indication:
The AtriClip Gillinov-Cosgrove LAA Clip is indicated for the occlusion of the left atrial
appendage, under direct visualization, in conjunction with other open cardiac surgical
procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart
directly, without assistance from a camera, endoscope, etc., or any other viewing
technology. This includes procedures performed by sternotomy (full or partial as well as
thoracotomy (single or multiple).
Source: “20140306 – AtriCure Products & IFU’s
(w/competitors), slide 60”; Dennis Hong
AtriClip Gillinov-Cosgrove™ Selection Guide
Product Codes: CGG1
Class I Device
Indication:
The AtriClip® Gillinov-Cosgrove™ Selection Guide (Guide)
is intended to be used as an accessory to the AtriClip®
LAA Exclusion System with preloaded Gillinov-Cosgrove™
Clip (Clip).
Source: “20140306 – AtriCure Products & IFU’s (w/competitors), slide 62”; Dennis Hong
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4/17/2015
AtriClip FLEX Available in US as of 9/15/2014
“A MORE FLEXIBLE SOLUTION FOR THE MOST WIDELY
PLACED LAA EXCLUSION DEVICE IN THE WORLD”
•Flexible 6cm shaft
•Plunger Grip
•Available in four sizes
Key Features
AtriClip
Science
Parallel beams
•
Follows natural orientation of
appendage orifice
•
Equalizes force over the length
of appendage
Nitinol springs
•
Dynamic compression force
(continues to close over time)
•
Force is proportional to tissue
thickness and an order of
magnitude less than staplers or
suture
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4/17/2015
Summary
• Left Atrial Appendage
– Thrombus formation
– 130K strokes/yr.
– 1/3 surgical patients develop atrial fibrillation
– Ligate or not to Ligate?
– Cardiac surgery + AF: concomitant Maze.
Key Features
7 day in growth, porcine model
AtriClip
Science
Polyester fiber sleeve
•
Encourages rapid tissue in
growth
•
Provides stability while LAA is
reabsorbed
Human Endocardial View at 4 months
•
Yields smooth healing of the
endocardium at the LAA LA
junction
Courtesy Marc Gerdisch, MD
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