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MedStar Washington Hospital Center Cardiac Catheterization Conference
JAMA. 2016;316(10): Ander Regueiro, MD FESC Fellow, Interventional Cardiology Quebec Heart & Lung Institute Quebec City, Canada MedStar Washington Hospital Center Cardiac Catheterization Conference November 2th, 2016
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Background Infective endocarditis (IE) following surgical valve replacement: 1% to 6% Data on IE after transcatheter aortic valve replacement (TAVR) have been limited to small series and case reports with restricted follow-up Incidence of IE within the year following TAVR: 0.5% to 3.1% 87% In-hospital complications 47% In-hospital mortality <10% Valve explantation JAMA. 2016;316(10):
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Aims Determine the clinical characteristics and outcomes of patients who develop IE after undergoing TAVR JAMA. 2016;316(10):
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Study flowchart JAMA. 2016;316(10):
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Study flowchart Global study cohort
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Study flowchart Individual Data Cohort
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Methods Statistical Analysis
Global Study Cohort Multivariable logistic regression model to assess factors associated with in-hospital death after IE Logistic EuroSCORE, stroke, heart failure, renal failure, and Staphylococcus aureus endocarditis Individual Data Cohort Multivariable Cox proportional hazard model to assess factors associated with IE after TAVR Age, sex, diabetes mellitus, chronic renal failure, chronic pulmonary disease, orotracheal intubation, and moderate to severe residual aortic regurgitation Missing data: Multivariable imputation using chained equations JAMA. 2016;316(10):
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Results Global Study Cohort
250 IE of patients after TAVR Incidence rate: 1.1% person-year (95%CI 1.1%- 1.4%) Median time between TAVR and IE: 5.3 months (IQR months) Early IE (within 12 months following TAVR): 71.2% IE within 2 months following TAVR: 28.8% JAMA. 2016;316(10):
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Results (Global Data Cohort Study) Baseline Characteristics
No. (%) of Patients N=250 Age, median (IQR), y 80 (59-91) Men 159 (63.6) Diabetes mellitus 97 (38.8) Chronic renal failure 117 (46.8) COPD 78 (31.2) Previous infective endocarditis 3 (1.2) Logistic EuroSCORE, median (IQR) 17.9 (10-28) JAMA. 2016;316(10):
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Results (Global Data Cohort Study) Procedural Characteristics
No. (%) of Patients N=250 Balloon-expandable valve 131 (52.4) Transfemoral approach 208 (83.2) Orotracheal intubation 137 (54.8) Device success (VARC-2) 204 (81.6) Residual AR (≥Moderate) 39 (15.2) Permanent pacemaker implantation 53 (21.2) JAMA. 2016;316(10):
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Results (Individual Data Cohort Study) Factors Associated with IE following TAVR
Non IE (N=6290) P Value Adjusted HR (95% CI) Age, median (IQR) 80 (74-83) 83 (78-87) <0.001 0.97 ( ) .001 Men 67 (62.0) 3016/6070 (49.7) .01 1.69 ( ) Diabetes mellitus 45 (41.7) 1577/5252 (30.2) .009 1.52 ( ) .04 COPD 39 (36.1) 1439/5709 (25.2) 1.35 ( ) .16 OT intubation 64 (59.2) 2347/4874 (48.2) .02 1.28 ( ) .22 Residual AR (≥Moderate) 22/98 (22.4) 770/5254 (14.6) .03 2.05 ( ) .003 JAMA. 2016;316(10):
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Results (Individual Data Cohort Study) Factors Associated with IE following TAVR
Non IE (N=6290) P Value Adjusted HR (95% CI) Age, median (IQR) 80 (74-83) 83 (78-87) <0.001 0.97 ( ) .001 Men 67 (62.0) 3016/6070 (49.7) .01 1.69 ( ) Diabetes mellitus 45 (41.7) 1577/5252 (30.2) .009 1.52 ( ) .04 COPD 39 (36.1) 1439/5709 (25.2) 1.35 ( ) .16 OT intubation 64 (59.2) 2347/4874 (48.2) .02 1.28 ( ) .22 Residual AR (≥Moderate) 22/98 (22.4) 770/5254 (14.6) .03 2.05 ( ) .003 JAMA. 2016;316(10):
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Results (Individual Data Cohort Study) Factors (NOT) Associated with IE following TAVR
Self-expandable valve IE 38.9% vs. Non IE 43.5%; P=.34 Catheterization laboratory IE 80.6% vs. Non IE 83.2%; P=.47 JAMA. 2016;316(10):
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Results (Global Data Cohort Study) Clinical and Microbiological Characteristics
No. (%) of Patients N=250 Health care-associated infection 132 (52.8) Unknown exposure (source of bacteremia ) 174 (69.6) Presumed intravascular – soft tissue infection 26 (10.4) Causative organism Enterococcus species 57/232 (24.6) Staphylococcus aureus 53/232 (23.3) Coagulase-negative Staphylococcus 41/232 (16.8) JAMA. 2016;316(10):
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Results (Global Data Cohort Study) Echocardiographic Characteristics
No. (%) of Patients (N=250) Vegetation 165 (67.6) At TAVR leaflet 79/165 (47.9) At TAVR stent 30/165 (18.2) Mitral 41/165 (24.8) Pacemaker lead 7/165 (4.8) Periannular complication 44/244 (18.0) JAMA. 2016;316(10):
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Results (Global Data Cohort Study) Management and Outcomes
No. (%) of Patients (N=250) Complications during IE hospitalization Any complication 160/238 (67.2) Heart failure 87/238 (36.6) Acute Kidney Injury 106/238 (44.5) Septic shock 66/238 (27.7) Surgery during IE hospitalization 37 (14.8) Surgical transcatheter valve explantation 27 (10.8) Transcatheter valve-in-valve procedure 3 (1.2) Isolated pacemaker extraction 7 (2.8) In-hospital death 90 (36.0)
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Results (Global Data Cohort Study) Factors associated with in-hospital death in patients with IE following TAVR Alive N=160 Death N=90 Adjusted OR (95% CI) P Value Logistic EuroSCORE 18.6 (12.2) 23.1 (14.1) 1.03 ( ) .02 Stroke 11 (7.2) 14 (16.3) 2.29 ( ) .10 Heart Failure 36 (23.6) 51 (59.3) 3.36 ( ) <0.001 Renal Failure 48 (31.6) 58 (67.4) 2.70 ( ) .002 S. Aureus endocarditis 31 (20.9) 30 (35.7) 1.76 ( )
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Results (Global Data Cohort Study) Factors associated with in-hospital death in patients with IE following TAVR Alive N=160 Death N=90 Adjusted OR (95% CI) P Value Logistic EuroSCORE 18.6 (12.2) 23.1 (14.1) 1.03 ( ) .02 Stroke 11 (7.2) 14 (16.3) 2.29 ( ) .10 Heart Failure 36 (23.6) 51 (59.3) 3.36 ( ) <0.001 Renal Failure 48 (31.6) 58 (67.4) 2.70 ( ) .002 S. Aureus endocarditis 31 (20.9) 30 (35.7) 1.76 ( )
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Results (Global Data Cohort Study) Follow-up
No. (%) of Patients (N=250) Follow-up time, mo 10.5 ( ) Total person-year 171.5 Recurrent infective endocarditis 15/160 (9.4) Death at follow-up 50/160 (31.5) 2-y mortality rate 66.7 (59.0 to 74.2)
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Results (Global Data Cohort Study)
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Conclusions Patients who developed endocarditis (Incidence rate 1.1% patient-year) had a high rate of in- hospital mortality (36%), with a low rate of valve explantation (10.8%) Younger age, male sex, diabetes mellitus, and moderate to severe residual aortic regurgitation were associated with a higher risk of infective endocarditis following TAVR
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