Complications after TAVI: VARC Definitions, Frequency and Management Considerations Patrick W. Serruys, Nicolo Piazza,
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1 Complications after TAVI: VARC Definitions, Frequency and Management Considerations Patrick W. Serruys, Nicolo Piazza, Nicolas M. Van Mieghem, Yoshinobu Onuma, Martin B. Leon TCT-AP 2011 April 27 th, :07 10:19 Main Arena Level B With the collaboration of the Working Group on Valvular l Heart Disease of the European Society of Cardiology
2 Cardiology Societies VARC online January Academic Research Organizations Surgery Societies
3 Myocardial infarction Stroke Bleeding Mortality Acute Kidney Injury Minimum Data Collection and Endpoint Requirements after TAVI Therapy specific endpoints Vascular complications Composite endpoints Prosthetic valve associated complications Prosthetic valve performance
4 Neurological Stroke Cardiac Conduction abnormalities Aortic regurgitation
5 Stroke - VARC 1. Rapid onset of a focal or global neurological deficit with signs or symptoms consistent with stroke 2. Typically y Duration of a focal or global neurological deficit 24 hours; OR < 24 hours, if therapeutic intervention(s) were performed (e.g. thrombolytic therapy or intracranial angioplasty); OR available neuroimaging OR the neurologic deficit it results in death 3. Exclusion of other cause for the clinical presentation (e.g. infection, hypoglycemia, pharmacological l influences ) 4. Confirmation by at least one of the following: Neurology or neurosurgical specialist Neuroimaging procedure (MR or CT scan or cerebral angiography) Lumbar puncture (i.e. spinal fluid analysis diagnostic of intracranial hemorrhage)
6 #1 Stroke More Stroke Definitions Stroke: Minor modified Rankin score < 2 at discharge Major j modified d Rankin score 2 at tdischarge Transient ischemic i attack: New focal neurologic deficit with rapid symptom resolution (usually 1-2 hours), always within 24 hours Neuroimaging without tissue injury
7 #1 Stroke Stroke at 30 days Edwards SAPIEN Medtronic CoreValve Perce ent (%) 3% 6% Weighted average 5.3% 2.4% 2.9% 2.7% 2.4% 1.8% 1.9%
8 #1 Stroke Stroke at 30 days Partner US Trial Cohort o A Cohort o B TAVI Surgery TAVI Medical Rx 38% 3.8% 21% 2.1% 67% 6.7% 17% 1.7%
9 #1 Stroke Time to stroke event within 30 days Partner US Cohort B Tim me to even nt (days) In the CoreValve Expanded Evaluation Registry 36% (n=646), of strokes 50% diagnosed of strokes were diagnosed after d 48 between hours 2-10days Major or minor stroke event (n=11) Piazza et al. EuroIntervention 2008
10 #1 Stroke Diffusion weighted MRI Silent Cerebral Insults after TAVI 84% (%) 68% 69% 73% 68% f patients Percent of
11 #1 Stroke Diffusion-Weighted MRI Study Philipp Kahlert, MD West German Heart Center Essen Pre-TAVI Post-TAVI Example of an 82-year-old patient two days after successful TAVI Embolic phenomenon Courtesy of E. Grube, MD
12 #1 Stroke Diffusion weighted MRI Silent Cerebral Insults after TAVI No difference in the number of silent cerebral insults between: Transfemoral vs. Transapical TAVI Edwards SAPIEN vs. Medtronic CoreValve Rodes-Cabau JACC 2011 Astarci EJCTS 2011 Khalert Circulation 2010
13 #1 Stroke What is the clinical significance of silent cerebral insults after TAVI? Silent cerebral insults had no influence on neurocognitive performance Khalert Circulation 2010 Ghanem JACC 2010 Rodes-Cabau JACC 2011
14 #1 Stroke Will Cerebral Embolic Protection Devices be the solution? Embrella Cardiovascular (deflector) Claret Medical (capture) SMT (deflector )
15 #1 Stroke Antiplatelet-Anticoagulant Rx Post TAVI Non-standardized ASA and Plavix for 3 months Coumadin and ASA (or Plavix) for 3 months
16 #2 Conduction Abnormalities TAVI & Conduction Abnormalities Piazza et al. JACC Interv 2008 (n=40) Calvi et al. PACE 2009 (n=30) Jilaihawi et al. Am Heart J 2009 (n=34) Erkapic et al. Europace 2010 (n=50) Haworth et al. CCI 2010 (n=50) Baan et al. Am Heart J 2010 (n=34) Latsios et al. Cath Cardiovasc Interv 2010 (n=81) Bleiziffer et al. JACC Interv 2010 (n=123) Piazza et al. EuroIntervention 2010 (n=91) Roter et al. Am J Cardiol 2010 (n=67) Ferreira et al. Pacing Clin Electrophysiol 2010 (n=32) Fraccaro et al. Am J Cardiol 2011 (n=70)
17 #2 Conduction Abnormalities Howfrequentisnew new-onset left bundle branch block (LBBB) after TAVI? Medtronic CoreValve 30 to 65%
18 #2 Conduction Abnormalities Edwards d SAPIEN Permanent pacing requirements 4 4to7% 21%
19 #2 Conduction Abnormalities Medtronic CoreValve Permanent pacing requirements 15 to 20% 18 to 47%
20 #2 Conduction Abnormalities CoreValve Siegburg Experience Indications for permanent pacemaking following TAVI Absolute 31% Relative 16% Latsios et al. Cath Cardiovasc Interv 2010
21 #2 Conduction Abnormalities Predictors PPM Medtronic CoreValve Pre-existing RBBB Depth of implantation Small LVOT/annulus S ll LVOT/ l Septal wall thickness Calcification
22 #2 Conduction Abnormalities Prophylactic Pacemaker Where do its origins lie? Left bundle branch block following surgical AVR is associated with complete AV block and sudden cardiac death at 1 year follow-up Am J Cardiol 2004 J Thorac Cardiovasc Surg 1982
23 #2 Conduction Abnormalities CoreValve Implantation Case Day 1 post-procedure LBBB Pre-procedure RBBB Day 3 Post-procedure LBBB
24 #2 Conduction Abnormalities Day 6 Post-implant
25 #2 Conduction Abnormalities Recommendations Temporary pacemaker for hours Continuous in-hospital rhythm monitoring Indications for permanent pacemaker implantation should follow published guidelines
26 #3 Aortic regurgitation Immediately after CoreValve implantation... Severe aortic regurgitation Aortic diastolic pressure ~ mmhg LVEDP = 25 mmhg Loss of dicrotic notch
27 Prosthetic Aortic Valve Regurgitation (JASE) Parameter Mild Moderate Severe LV size Normal Normal/mildly dilated Jet width in central jets (% LVO Narrow (<25%) Intermediate (26- diameter) 64%) dilated Large ( 65) Jet density /CW Doppler Incomplete/faint Dense dense Jet deceleration time (PHT, ms) Slow (>500) Variable ( ) Steep (<200) CW Doppler LV outflow vs. pulmonary flow: PW Doppler Slightly increased Intermediate Greatly increased Diastolic flow reversal in desc. aorta: PW Doppler Abent or brief early diastolic Intermediate Prominent, holodiastolic Circumferential extent of paravalvular AR (%) < >20 Regurgitant volume (ml/beat) < >60 Regurgitant fraction (%) < >50
28 #3 Aortic regurgitation Frequency of Aortic Regurgitation (Peer-reviewed) 10-30% MEDTRONIC COREVALVE EDWARDS SAPIEN 70-90% 10-30% Rajan et al. Catheter Cardiovasc Interv 2009 Jilaihawi et al. Eur Heart J 2009 Moss et al. JACC Cardiovasc Imag 2008 Clavel et al. J Am Coll Cardiol 2009 Himbert et al. J Am Coll Cardiol 2008 Detaint et al. JACC Cardiovasc Interv 2009
29 #3 Aortic regurgitation Paravalvular Aortic Regurgitation g PARTNER US Cohort B At 1 year follow-up 45% - No aortic regurgitation 55% - Some degree of regurgitation 30 Day 6 Month 1 Year None/Trace Mild Moderate Severe
30 #3 Aortic regurgitation Courtesy of the German Heart Center Munich (R. Lange)
31 #3 Aortic regurgitation Post-procedure Intermittent t hemodynamic instability Echocardiography - no relevant findings during times hemodynamic stability
32 #3 Aortic regurgitation Post-procedural evolution Post-operative day 3 Severe central aortic regurgitation during HD instability Surgical gca exploration po ato
33 #3 Aortic regurgitation Surgical Exploration Prosthetic valve leaflet Native aortic valve leaflet Native aortic valve leaflet impinging on prosthetic valve leaflet impeding normal leaflet motion
34 #3 Aortic regurgitation Mechanisms of Aortic Regurgitation Malposition of prosthesis Undersizing prosthesis Underexpansion of prosthesis Malapposition of prosthesis Aggressive pre-dilatation during BAV Guidewire or pigtail catheter interfering with leaflet coaptation
35 #3 Aortic regurgitation 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) Coli et al. Circulation 2009;120:S982 Operator experience 2.24 (95% CI ) lsizing and calcium Degree of valve calcification (TEE) 8.47 (95% CI 1.22 to 58.92) Asymmetry of valve calcification (TEE) (95% CI 1.52 to ) Delgado et al. Annulus size (MSCT) Circulation 2009;120;S957 (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)
36 #3 Aortic regurgitation Treatment of paravalvular aortic regurgitation Post-implant balloon dilatation Valve-in-valve Moderate severe aortic regurgitation should be Moderate-severe aortic regurgitation should be treated if possible
37 Hypotension during or after TAVI 1.Cardiac tamponade (Echo) 2.Myocardial ischemia (ECG) 3.Major bleeding (MSCT)
38 Stepwise Care hours in intensive care Transfer to medium care or general ward for 5 days Average length of stay 5-7 7days.
39 Overall Things to Watch For Signs of stroke Bleeding Post-care TAVI needs that we acquire a ECG new rhythm knowledge disturbances base of pathophysiological Renal problems mechanisms that may lead to otherwise common signs and symptoms Myocardial ischemia Cardiac tamponade Vascular access issues
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