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1 Italian OBservational Study of Effectiveness of AVR TAVI procedures for severe Aortic stenosis Treatment Subgroup Analyses Corrado Tamburino SOCIETA' ITALIANA DI CHIRURGIA CARDIACA onlus ITACTA ITALIAN ASSOCIATION OF CARDIOTHORACIC ANESTHESIOLOGISTS
2 OBSERVANT OBSERVANT started in December 2010 in Italy with the aim of addressing comparative effectiveness of TAVI and AVR procedures for the treatment of SSAS in a real population It is based on the development of a unique database for contemporary data collection on both procedures
3 METHODOLOGY STUDY DESIGN Observationalprospectivemulticentercohortstudy STUDY POPULATION All adult patients admitted to hospitals with a diagnosis of SSAS and requiring an interventional treatment (TAVI or AVR) DATA COLLECTION (18 months) includes information on: - demographic characteristics - health status prior to intervention - therapeutic approach END POINTS AND FOLLOW UP - Procedural outcomes (i.e.: PAV block, stroke, vascular damage, ) - Mortality within 30 days and 6 months from intervention - Mortality and incidence of in hospital major adverse cardiac and y p j cerebrovascular events (MACCE) within 12 and 24 months
4 OBSERVANT
5 OBSERVANT D Errigo et al, Int J Cardiol 2012
6 OBSERVANT D Errigo et al, Int J Cardiol 2012
7 Potential analyses Impact of perioperative moderate/severe mitral regurgitation Design of a procedural risk score dedicated for TAVI Impact of anesthesiology regimen in TAVI and SAVR. Thanks
8 PARTNER Leak Smith et al, NEJM 2012
9 ADVANCE Leak Linke, EuroPCR 2013
10 OBSERVANT Leak age (%) Percent , ,9 AVR (n=5066) TAVI (n=1633)
11 OBSERVANT Leak age (%) Percent 8 13,4 4 7,6 0 CoreValve (n=855) SAPIEN XT (n=775)
12 TAVI U.K. Registry Leak Moat et al. JACC 2012
13 OBSERVANT Leak ity (%) Mortal ,6 7,5 5,2 P<0,001 4,3 P=0, ,20 All None/mild Mod/sev All None/mild Mod/sev TAVI AVR
14 OBSERVANT Leak 15 P<0, ity (%) 10 P=0,038 Mortal 5 6,0 11,7 7,6 0 3,0 2,22 2,22 None Mild Mod/sev None Mild Mod/sev TAVI AVR
15 Impact of PVR AVR All Mod/sev None/mild P value PVR PVR Death, n (%) 116 (2,0) 4 (7,5) 112 (2,2) 0,034 Myocardial infarction, n (%) 28 (0,5) 1 (1,9) 27 (0,5) 0,345 Stroke, n (%) 74 (1,4) 2 (3,8) 72 (1,0) 0,319 Majorvascular complications, n (%) 11 (0,2) 0 (0,0) 0) 11 (0,2) 0,574 TAVI All Mod/sev PVR None/mild PVR P value Death, n (%) 95 (5,2) 24 (11,6) 71 (4,3) <0,001 Myocardial infarction, n (%) 14 (0,8) 2 (0,9) 12 (0,7) 0,932 Stroke, n (%) 23 (1,2) 5 (2,4) 18 (1,1) 0,188 Major vascular complications, n (%) 118 (6,4) 15 (7,3) 103 (6,3) 0,634
16 OBSERVANT CAD Prevalence of CAD: 37% of patients with AS [Meta analysis, analysis Mauter AmJ Cardiol1992]
17 STS Database Mortalit ty (%) AVR + CABG AVR Years
18 OBSERVANT CAD These guidelines not applicable in context of TAVI
19 OBSERVANT CAD TAVI: position statement from EACTS and ESC, in collaboration with EAPCI
20 OBSERVANT CAD Open Issues: Impact of CAD in the context of TAVI Indications for PCI Timing of PCI Complete or incomplete revascularization DES vs BMS
21 OBSERVANT CAD
22 Impact of Revascularization after TAVI Ussia et al. IJC 2012
23 OBSERVANT CAD No Patients Isolated AVR AVR+CABG Isolated TAVI TAVI+PCI* *PCI performed within 6 months or in the same setting of TAVI
24 OBSERVANT CAD No Patients A direct comparison of these two groups may provide important information in this particular subset of patients Isolated AVR AVR+CABG Isolated TAVI TAVI+PCI* *PCI performed within 6 months or in the same setting of TAVI
25 OBSERVANT CAD Morta ality (%) 4 3 5,9 6,4 2 3,6 1 1,9 0 Isolated AVR AVR+CABG Isolated TAVI TAVI+PCI* *PCI performed within 6 months or in the same setting of TAVI
26 OBSERVANT CAD 2,0 1,5 Procedu ural MI (% %) 1,0 1,5 1,7 0,5 0,7 0,3 0,0 Isolated AVR AVR+CABG Isolated TAVI TAVI+PCI* *PCI performed within 6 months or in the same setting of TAVI
27 OBSERVANT CAD 3,0 2,5 Procedura al Stroke (%) 2,0 1,5 1,0 2,23 0,5 1,12 1,4 1,11 0,0 Isolated AVR AVR+CABG Isolated TAVI TAVI+PCI* *PCI performed within 6 months or in the same setting of TAVI
28 TAVI & PCI 8,0 P=0,184 6,0 Morta ality (%) 4,0 6,0 6,0 5,5 2,0 0,0 No PCI PCI<6 months PCI>6 months
29 TAVI & PCI 2 Procedu ural MI (% %) 1,5 1 0,5 0,79 P=0,605 1,27 0,5 0 No PCI PCI<6 months PCI>6 months
30 OBSERVANT Gender Results Differ Between Trans aortic and Open Surgical Aortic Valve Replacement in Women: a Propensity Matched Study of The Italian OBSERVANT Registry Francesco Onorati, MD PhD, Paola D Errigo, MSc, Marco Barbanti, MD, Stefano Rosato, MSc, Daniel Remo Covello, MD, Alice Maraschini, MSc, Marco Ranucci, MD, Claudio Grossi, MD, Gennaro Santoro, MD, Corrado Tamburino, MD, Francesco Santini, MD, and Fulvia Seccareccia, MSc, on behalf of the OBSERVANT Research Group. in press Annals of Thoracic Surgery
31 OBSERVANT Gender Variables savr (194 patients) TAVR (194 patients) Hospital Mortality (%) 9 (4.1) 17 (3.1).177 Perioperative AMI (%) 11 (5.7) 15 (7.7).124 Length of hospitalization (days) 10.6± ± ICU length of stay (days) 3.7± ± Favors savr Stroke (%) 5 (2.5) 15 (7.7).037 Major Vascular Complications (%) 1 (0.5) 18 (9.3).0001 Permanent PPM implantation (%) 12 (6.2) 24 (12.4).004 Emergent post procedural revascularization (%) 0 ( ) 2 (1.0).007 ImCU length of stay (days) 1.4± ± Favors TAVR Low Cardiac Output State (%) 11 (5.7) 7 (3.6).017 Acute Renal Insufficiency (%) 17 (8.8) 8 (4.1).010 Transfusion (%) 124 (63.9) 72 (37.1).0001 Transfusions/patient (Units) 3.6± ± Echocardiographic findings PeakTrans prosthetic Gradient (mm/hg) 28.1± ± MeanTrans prosthetic Gradient (mm/hg) 15.7± ± Moderate/severe aortic regurgitation 3 (1.5) 14 (7.1).0001 p
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stenosis (AS) at our center between June 2007 and December 2010, with last follow-up contact in 2016.
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