1. Lessons from complications: Balloon-Expandable Edwards SAPIEN and the Self-Expanding Medtronic CoreValve
Sunday February 21, 2010
4:10 – 4:20 pm, Diplomat Ballroom
CRT Washington
Nicolo Piazza, MD, FRCPC (Leipzig Herzzentrum)
Peter de Jaegere, MD, PhD (Erasmus Medical Center)
Patrick W. Serruys, MD, PhD (Erasmus Medical Center)

2. Disclosures
Medtronic Consultant

3. Objectives
To discuss 2 common and 1 rare complication following transcatheter aortic valve implantation (TAVI) in order to highlight some of the challenges to understanding TAVI complications
Aortic regurgitation
Conduction disturbances
“TAVE”

4. Immediately after CoreValve implantation . . .
Severe aortic regurgitation
Aortic diastolic pressure ~ mmHg
Loss of dicrotic notch
LVEDP = 25 mmHg

5. Frequency of Aortic Regurgitation (Peer-reviewed)
MEDTRONIC COREVALVE
EDWARDS SAPIEN
10-30%
70-90%
10-30%
Rajan et al. Catheter Cardiovasc Interv 2009
Clavel et al. J Am Coll Cardiol 2009
Jilaihawi et al. Eur Heart J 2009
Himbert et al. J Am Coll Cardiol 2008
Moss et al. JACC Cardiovasc Imag 2008
Detaint et al. JACC Cardiovasc Interv 2009

6. The problem in summarizing these data and making conclusions . . .
Imaging modalities
Timing of assessment
Disparities amongst studies
Classification and reporting of AR
Quantification of AR
Varying physician thresholds to treat AR

7. Mechanisms of Aortic Regurgitation
Too high or too low implantation
Prosthesis underexpansion
Dense calcifications or commisural fusion causing deformation or malapposition of the prosthesis
Undersized or severely oversized prosthesis
Aggressive pre- or post-implant dilatation
Guidewire or pigtail catheter interfering with leaflet coaptation
Prolapse of native valve leaflet or calcific nodules into prosthetic valve impeding normal leaflet excursion
Intrinsic malfunctioning of prosthetic valve leaflets

8. Predictors of AR (Edwards SAPIEN)
Detaint et al.
JACC Interv 2009;2:82107
“Cover Index” (TEE)
1.22 (95% CI 1.03 to 1.52)
Operator experience
2.24 (95% CI )
Coli et al.
Circulation 2009;120:S982
Degree of valve calcification (TEE)
8.47 (95% CI 1.22 to 58.92)
Asymmetry of valve calcification (TEE)
13.70 (95% CI 1.52 to )
Delgado et al.
Circulation 2009;120;S957
 Annulus size (MSCT)
(28.2±1.8 mm vs. 24.8±2.3 mm, p=0.003)
Degree of valve calcification (MSCT)
(4127±2071 HU vs. 2470±1264 HU, p=0.037)

9. Treatment Options AR Post-implant balloon dilatation Edwards SAPIEN
Medtronic CoreValve

10. Treatment Options for AR
Valve-in-Valve
Edwards SAPIEN
Medtronic CoreValve
Serruys et al. TAVI – Tips and tricks to avoid failure. Informa Healthcare 2010

11. Treatment Options for AR
Repositioning (Goose-neck snare)
Snare
Medtronic CoreValve
Courtesy of E. Grube, MD

12. Treatment Options for AR
Surgical Aortic Valve Replacement
Courtesy of C. Eberhardt

13. Long-term clinical implications of AR after TAVI . . .?

14. CoreValve Implantation Case
Day 1 post-procedure
LBBB
Day 3 post-procedure
LBBB
Pre-procedure
RBBB

15. Day 6 Post-implant
Serruys et al. TAVI – Tips and tricks to avoid failure. Informa Healthcare 2010

16. New Permanent Pacemaking within 30 days
CoreValve
% patients
Weighted average = 23%
(n=1990 patients)

17. New Permanent Pacemaking within 30 days
18F Safety and Efficacy Study (n=126)
* 2 centers with < 5 implants excluded from the presentation; both centers had 0% 30-day permanent pacemaking
Need for standardization of practice patterns
% patients
Participating Centers
Overall permanent pacemaking rate 25%

18. New Permanent Pacemaking within 30 days
Edwards
% patients
Weighted average = 7%
(n=1644 patients)

19. Long-term clinical implications of conduction abnormalities after TAVI . . .?

20. Prosthetic valve endocarditis
Transcatheter Aortic Valve Endocarditis (TAVE)
Prosthetic valve endocarditis
88 year old - 26 mm Edwards SAPIEN “low implantation”
At 11 months - fever (S. angiosus)
Thickening of leaflet and nodular endocarditic excrescences
Wong et al. J Thorac Cardiovasc Surg 2009;137:

21. Transcatheter Aortic Valve Endocarditis (TAVE)
66 year old - 26 mm CoreValve (low implantation)
At 3 months - fever (Corneybacterium)
Courtesy of Comoglio et al. J Thorac Cardiovasc Surg 2009

22. Aneurysm of the Anterior Mitral Valve Leaflet
A mere coincidence?
CoreValve
Edwards
Piazza et al. J Thorac Cardiovasc Surg, doi: /j.jtcvs , Feb. 16, 2010

23. Summary
Data sources are mostly from single-center, retrospective observational studies
Significant heterogeneity in the definition of endpoints, practice patterns and reporting styles makes interpretation of these data challenging
Paucity of data on the mechanisms and predictors of complications after TAVI
Clinical implications of aortic regurgitation and conduction abnormalties following TAVI are currently unknown

24. Device-Patient Interface!
. . . recounts examples of how various medical devices failed and caused severe injury and death.
While some of those failures resulted from bad engineering, others were simply incidents that resulted from inadequate knowledge of the environment in which these medical devices were meant to function.
If one does not know the [environment] and full range of insult to which a medical device will be exposed, it is impossible to design for it.
Device-Patient Interface!