1. Transcatheter Mitral Repair Complications & Bailout(s)
Peter C. Block M.D.
Andreas Gruentzig Cardiovascular Center
Emory University, Atlanta, GA.
Transcatheter Mitral Repair Complications & Bailout(s)
CRT
Washington, DC
Feb 5, 2012

2. Conflict of Interest None

3. Percutaneous Edge to Edge Mitral Valve Repair: Lots of steps to be taken carefully
Transseptal
puncture
Mullins Sheath
in LA
TEE probe
Guidewire
Delivery
Sheath
Dilator
LAA
Device in LA
Device opened
in LV
Device closed onto
mitral leaflets
Device released

4. Lots of Potential Complications
Access
Trans-septal
Pericardial effusion
Tamponade
Stroke
Thromboembolism
Air
Trauma to the mitral valve
Clip embolism
Partial clip detachment
Worsening MR
BUT in Reality…..
In EVEREST II RCT (n=136):
1 GI complication
12 pts with transfusion
0 death
0 stroke

5. Nevertheless…… The LA is NOT a user-friendly place:
Frequently not roomy;
Don’t hit the thin wall;
Stay out of the LAA;
PV’s are thin walled and confusing;
Once across the MV –
Don’t cut chordae
Watch out for VT
Left Atrium

6. Echo Guidance (High/posterior)
Trans- Septal Puncture Site
Echo Guidance (High/posterior)
Thrombus on the Wire

7. Difficult Trans- Septal Puncture
Puncture into the Aorta
Distorted Anatomy

8. Contra-Indications to Transseptal Puncture
Product Insert Medtronic transseptal needle:
distorted anatomy due to congenital heart disease
significant chest or spine deformity
inability to lie flat
ongoing anticoagulation
marked atrial enlargement
left atrial thrombus or tumor
dilated aortic root
previous patch repair of the atrial septum.
Possibly ----Pacemaker leads, inferior vena cava filters
Atrial thrombus or mass:
Right atrial thrombus +/-
Organized thrombus in LA appendage apex is NOT a contraindication
“Smoke” (low LA pressure flows) is NOT a contraindication
Coagulopathy
INR >1.7 (or so)
Platelets count <50K
Recent heparin

9. In Reality: only absolute contra-indications to transseptal puncture are: 1: thrombus located at the septum : atrial myxoma or other tumor arising from the septum.

10. Pain Neck Wire or dilator in IJ Shoulder Wire in hepatic vein
Pericardial irritation
Abdomen
Passage of sheath or needle over pelvic brim
Needle exit through sheath-dilator
Chest
Pericardial, atrial, or aortic perforation
Sensitive septum
DO NOT IGNORE PT SYMPTOMS (>95% of
TS punctures are not felt by pt.)

11. To minimize problems Vascular injury Dilator Needle
BE GENTLE : SHARP OBJECTS = SHARP
Cardiac perforation
Aorta LA
Transverse pericardial sinus
TEE needed for MitraClip procedure is your friend
Thromboembolism from catheter in LA
BE METICULOUS

12. HRR: Major Adverse Events - 30 days
No Procedural Deaths / Freedom from MAE 74%
MAE
# Patients
Death 6 MI
Stroke
Renal Failure 1
Permanent Atrial Fibrillation
Ventilation >48 hrs
Transfusion ≥ 2U blood 11
TOTAL Patients with MAE
20*
Additional MAE in 6 deaths: MI (1), Stroke (1), Renal Failure (2), Ventilation (1), Transfusion (2)
Cause of death in 6 patients:
05-202: RHF died w/in24 hours (FMR). 2 clips placed, Event leading to death: Right heart failure/ severe CAD
33-205: Died 4 days (FMR), 1 clip placed, MR reduction not adequate, Event leading to death: Acute pulmonary edema & hemodynamic instability
30-201: Died in 9 days (DMR), no clip, Event leading to death: Transseptal complication with pericardial effusion. Death due to renal failure
09-201: Died 11 days (FMR), 2 clips placed, Event leading to death: Retroperitoneal hematoma with significant blood loss
09-202: Died 13 days (DMR), 1 clip, no APS, Event leading to death: GI bleeding, aspriation pneumonia
20-208: Died 19 days, no clip, Event leading to death: Congestive heart failure
Transfusions due to anemia in 5 of 11 patients

13. The delivery catheter tip-loss problem -- now resolved
With thanks to Ted Feldman

14. The delivery catheter tip problem (now resolved)
3 pts with delivery tip detachment
All high risk for op pts.
2 pts (EU) : tip in LV &
PV: to OR: 1 pt good
outcome: 1 pt died post-
op (unrelated to clip)
1 pt: tip snared in LA
additional clip placed
good outcome

15. Partially Detached Clip
What else can happen
During/after a MitraClip procedure?
Partially Detached Clip

16. HRR: Partial Clip Detachment
Low Incidence of partial clip detachment
in High Risk Population
Clip Embolization 0 in > 600 implants
Partial Clip Detachment 2/78 (2.6%)
1 Procedural
1 >30days
Incidence in preliminary cohort (n=107): % LEARNING CURVE

17. Partial clip detachment
Usually occurs in first weeks
Produces recurrence of MR
Detachment is from one leaflet
No complete detachment reported
BAILOUT: Surgical mitral repair
Good news; mitral repair can be
done up to years later
Success
With thanks to
Michael Argenziano MD
Columbia Med Ctr. NY
Surgical revision after percutaneous
mitral repair with the Mitraclip device
Ann. Thorac Surg Jan 2010

18. Conclusion
Safety
So far …The data support that patients with severe MR --even those at high risk, can undergo MitraClip repair safely. The risk of serious complications is low.
But remember “The greatest trick the Devil ever pulled ….was convincing the world he didn’t exist.” BE CAREFUL
(Verbal Kint: Usual Suspects)