TAVI bei niedrigem und mittlerem Risiko - Christoph Kaiser
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Kardiologie
TAVI bei niedrigem und mittlerem Risiko
Christoph Kaiser
2008
TAVI: Historische Entwicklung
t
Andersen- Cribier-
Prototype Edwards
SAPIEN SAPIEN XT SAPIEN 3
1992 2002 2006 2009 2013
Andersen HR et al, Eur Heart J 1992;13:704–8
Cribier A et al, Circulation 2002;106:3006-3008
TAVI: Historische Entwicklung Prendergast BD, et al. Eur Heart J 2019;40:422-40
TAVI: Historische Entwicklung
Reduktion des Schleusen-Durchmessers
Cribier-
Edwards
SAPIEN SAPIEN XT SAPIEN 3
2002 2006 2009 2013
2020
2020
?
Adapted from Head SJ et Kappetein P, EuroIntervention 2010;6:560-561
Aktuelle Guidelines Baumgartner H et al., European Heart Journal (2017) 38, 2739–2791
2020
PARTNER 3
Evolut Low-Risk
Adapted from Head SJ et Kappetein P, EuroIntervention 2010;6:560-561
Evolut Low-Risk Trial • Randomized controlled open-label trial • Severe aortic stenosis with risk ≤3% (STS-Score) • Randomization 1:1 TAVI (CoreValve, Evolut R, Evolut PRO) vs. SAVR (bio) • Primary endpoint noninferiority or superiority of a composite of all-cause death and disabling stroke at 24 months • n=1468 patients • Enrollment period 3/2016-11/2018 • Study sponsor manufacturer of TAVI prosthesis (Medtronic) Popma JJ, et al. N Engl J Med 2019;380:1706-1825
Evolut Low-Risk Trial Popma JJ, et al. N Engl J Med 2019;380:1706-1825
Evolut Low-Risk Trial
Primary Endpoint
Popma JJ, et al. N Engl J Med 2019;380:1706-1825Evolut Low-Risk Trial
Clinical outcome
Popma JJ, et al. N Engl J Med 2019;380:1706-1825PARTNER-3 • Randomized controlled open-label trial • Severe aortic stenosis with risk ≤4% (STS-Score) • Patients with clinical frailty, bicuspid aortic valves, or other anatomical features that increased the risk of complications associated with either TAVI or surgery were excluded • Randomization 1:1 TAVI (Sapien 3) vs. SAVR (bio) • Primary endpoint noninferiority or superiority of a composite of all-cause death, stroke and re-hospitalisation at 12 months • n=1000 patients • Enrollment period 3/2016-10/2017 • Study sponsor manufacturer of TAVI prosthesis (Edwards) Mack MJ, et al. N Engl J Med 2019;380:1695-705
PARTNER-3 Mack MJ, et al. N Engl J Med 2019;380:1695-705
PARTNER-3
Primary Endpoint
Mack MJ, et al. N Engl J Med 2019;380:1695-705PARTNER-3 Single components of Primary Endpoint Mack MJ, et al. N Engl J Med 2019;380:1695-705
2019
Bei den letzten 30 TAVI Cases im USB 2019 war
Der mittlere STS: 3.352019 www.ptca.ch (in press)
2019 Courtesy F. Maisano
Caveat ! GARY-Register (DE): TAVI oder chirugischer AKE bei low-risk Patienten (n=20’549) Bekeredjian R et al. Eur Heart J 2019;40:1323-30
Bei den letzten 30 TAVI Cases im USB 2019 war
Der mittlere STS: 3.35
Das mittlere Alter: 81,1Caveat ! Sondergaard L. Eur Heart J 2019;40:1331-33
TAVI bei niedrigem und mittlerem Risiko
Zusammenfassung:
• TAVI in bei inoperablen oder high-risk Patienten Heart Team !
• TAVI bei intermediate risk Patienten Heart Team !
• TAVI bei älteren low-risk Patienten Heart Team !
• TAVI bei jüngeren low-risk Patienten Heart Team !
Daten über Langzeiteffekte von paravalvulären Lecks,
def. Schrittmachern, Langlebigkeit der TAVI-Prothesen
Weitere Verbesserung der TechnologieBesten Dank für Ihre Aufmerksamkeit !
Society of Thoracic Surgery (STS) Risk Score
• Age • Chronic lung disease • Vtach/Vfib
• Sex • Illicit drug use • Inotropic, intravenous
• Race • Alcohol use • ADP inhibitor (includes P2Y12)
• Primary payor • Pneumonia • ADP inibitor discontinuation
• Weight/Height • Tobacco use • ACE or ARB
• Hematocrit • Home oxygen • Steroids
• WBC count • Previous cardiac intervention • Glycoprotein Iib/IIIa
• Platelet count • Previous CABG • Resuscitation
• Creatinine level • Previous valve procedure • Number of diseased vessels
• Dialysis • Other previous cardiac interventions • Percent stenosis left main
• Hypertension Low Risk
• 8
Heart failure timing
•
•
Mitral stenosis
Aortic insufficiency
• Cancer within 5 years • Classification NYHA • Mitral insufficiency
• Familiy history of premature CAD • Symptoms at time of this admission • Tricuspid insufficiency
• Sleep apnea • Cardiogenic shock • AV disease etiology
• Liver disease • Afibrillation • Incidence
• Unresponsive state • Aflutter • Status
• Syncope • Third degree heart block • IABP insertion
• Diabetes • Second degree heart block • Catheter based assist device used
• Endocarditis • Sick sinus • ECMO
http://riskcalc.sts.org/stswebriskcalc/calculate
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