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)

Disclosures Medtronic Consultant

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”

Immediately after CoreValve implantation . . . Severe aortic regurgitation Aortic diastolic pressure ~ 30-35 mmHg Loss of dicrotic notch LVEDP = 25 mmHg

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

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

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

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 1.07 5.22) 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 122.40) 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)

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

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

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

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

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

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

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

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

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%

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

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

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;137:1547-1549

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

Aneurysm of the Anterior Mitral Valve Leaflet A mere coincidence? CoreValve Edwards Piazza et al. J Thorac Cardiovasc Surg, doi: 10.1016/j.jtcvs.2009.11.012, Feb. 16, 2010

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

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!