TAVI Διαδερµικά τοποθετούµενες συσκευές στην αορτική βαλβίδα. Είµαστε έτοιµοι για την χρήση τους σε µετρίου ή χαµηλού κινδύνου ασθενείς στην Ελλάδα Κωνσταντίνος Τούτουζας Αν. Καθηγητής Καρδιολογίας Α Πανεπιστηµιακή Καρδιολογική Κλινική Ιπποκράτειο Νοσοκοµείο
Patient Selection TCT 2014
2014 ACC/AHA Guidelines Valvular Heart Disease Nishimura et al., Circulation, 2014
Trends in TAVI - Rising number of procedures - Age is decreasing N= 88.573 AVR= 55.992 TAVI= 32.581 Reinohl et al., NEJM 2015
Υψηλού κινδύνου TAVI
PARTNER A Trial: 5 Years Median Survival Time M. Mack, ACC 2015
PARTNER B: 5 Years Median Survival Time Samir Kapadia, TCT 2014
Υψηλού κινδύνου Μετρίου κινδύνου TAVI
SAPIEN 3 TAVI superior to surgery V. Thourani et al, Lancet, 2016
NOTION Trial Randomization to CoreValve or surgery Average STS score was about 3.0 and more than 80% had a score of less than 4
NOTION Trial 2-year outcomes Equivalence between the 2 methods Søndergaard L et al, Circ Cardiovasc Interv, 2016
SURTAVI Trial Trial Design Up to 2500 patients at up to 75 global sites will be included in the trial. All patients will complete a minimum of 24 months of in clinic follow-up. Clinical endpoints will be reported and adjudicated according to Valve Academic Research Consortium (VARC) standard endpoint definitions.
SURTAVI Trial Propensity Score Matching Among Intermediate-Risk Surgical Patients Cumulative all-cause mortality at 30 days and 1 year was similar STS trend N. Piazza et al, JACC Interv, 2013
PARTNER 2 TAVI: More MVC M. Leon et al, NEJM, 2016
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TAVI Υψηλού κινδύνου Μετρίου κινδύνου Προβληµατισµοί: Βηµατοδότες, PVL, µακροχρόνια αποτελέσµατα Ειδικοί πληθυσµοί
Remaining Challenges
The prevalence of implanted cardiovascular electronic devices in transcatheter aortic valve implantation patients. ICED, implanted cardiovascular electronic devices; CV, CoreValve; ES, Edward Sapien valve; PPM, permanent pacemaker. Mohammad Abdelghani et al. EHJ 04/2016
Cut-points of paravalvular leakage severity that are linked to worse prognosis Technique Parameter, cutpoint Risk Mohammad Abdelghani et al. EHJ 04/2016
Impact of AR on Mortality CoreValve Pivotal Trial Popma et al. JACC 2014
Effect of Acuteness of AR on Mortality After TAVI: Multicenter Study (1735 Patients) Jerez-Valero et al. JACC Intv 7.2014
Representation of the location of infective endocarditis (IE) in patients with previous transcatheter aortic valves Ignacio J. Amat-Santos et al. Circulation 3/2015
Survival after aortic valve replacement with mechanical valves vs. bioprostheses.
Survival after aortic valve replacement with mechanical valves vs. bioprostheses
Risk of stroke, reoperation, major bleeding, and cardiovascular death, mechanical valves vs. bioprostheses
TAVI Υψηλού κινδύνου Μετρίου κινδύνου Προβληµατισµοί: Βηµατοδότες, PVL, µακροχρόνια αποτελέσµατα Ειδικοί πληθυσµοί
Οριζόντια Αορτή Α Πανεπιστηµιακή Καρδιολογική Κλινική
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Predilatation The DIRECT Trial The predilation in transcatheter aortic valve implantation Trial (NCT02448927) Patient evaluation by Heart Team 3 International TAVI Centers Hippokration Hospital: Core Lab TAVI 1:1 Randomization N= 170 randomized patients BAV No-BAV Primary endpoint: Device success based on VARC-2 Secondary endpoint: In-hospital death, stroke, PPM, mortality
ipad App PCR Valve Atlas (2014) Special Contributors G. Latsios A. Synetos K. Toutouzas
Conclusions Aortic stenosis has become a fully treatable disease entity. TAVI has shown great long-term results. TAVI results > 10 years are eagerly awaited. Novel TAVI devices are constantly being developed. Newer indications for TAVI are aortic insufficiency and mediumrisk patients. The HEART TEAM should be involved when dealing with patients.
Μελλοντικές Προοπτικές - Size (14 Fr) - Risk scores - Concomitant valvular disorders - Alternative routes - Balloon predilatation - Anti-coagulation - Pacemaker - VIV -Need for back-up
TAVI 2002-2015 Increase in available valves Size availability K. Toutouzas, K. Stathogiannis, G. Latsios, A. Synetos, C. Stefanadis, 2012 - Rec Pat Cardiovasc Dr Disc
Προγνωστικά Μοντέλα στην TAVI Χρησµοί της Πυθίας ή Επιστηµονικά δεδοµένα; Risk scores STS score and log EuroSCORE have low c-indexes between 0.49-0.70. Although the 3 scores were not predictive for 30 day mortality the updated EuroSCORE II had better accuracy with area under curve of 0.70. The STS score had the worse predictive value in short term mortality and there was no difference in STS score between survivals and non-survivals 410±22 days. Toutouzas K, Stefanadis C., Cardiology, 2013
Trans-carotid TAVI Alternative routes Guyton, CCI 2012 Thourani, ATS 2013
Trans-caval TAVI Crossing Alternative routes Sheath insertion Greenbaum, PCR 2014
Direct TAVI with CoreValve 1 Year Outcomes Predilatation K. Toutouzas et al., IJC 2015 / ACC 2015
TAVI for failed surgical bioprostheses 1-Year outcomes from PARTNER II V-I-V Registry TCT 2015
German TAVI Registry Need for on-site cardiac surgery? Similar mortality rates for both groups CS hospitals: 1254 non-cs hospitals: 178 Eggebrecht et al., Eurointervention, 2015
Need for extracorporeal circulation? K. Toutouzas et al., CCI, 2015
Νεότερα δεδοµένα 2016 Μακροχρόνια αποτελέσµατα Νεότερες βαλβίδες Μελλοντικές προοπτικές Πειραµατικά µοντέλα
Inflammation and thermal heterogeneity in aortic stenosis Inflammatory CD3 infiltrates in AVS Association of inflammatory and neovascularization factors with temperature differences Toutouzas K, Drakopoulou M, Synetos A, Tsiamis E, Agrogiannis G, Kavantzas N, Patsouris E, Iliopoulos D, Theodoropoulos S, Yacoub M, Stefanadis C JACC - 2008
Topical infusion of bisphosphonates Effect on arterial wall calcification Placebo Zolendronate Αντιπροσωπευτικές τοµές µε χρώση Von Kossa από το ίδιο ζώο. Η περιεκτικότητα σε ασβέστιο είναι πολύ µικρότερη στην αρτηρία όπου έγινε τοπική έγχυση διφωσφονικού Toutouzas K, Synetos A, Benetos G, Drakopoulou M, Trantalis G., Kotronias R., Agrogiannis G., Tsiamis E., Deutereos S, Davlouros P, Patsouris E, Stefanadis C, Int. J Cardiol - 2014
Topical infusion of bisphosphonates Effect on arterial wall calcification Valve Leaflet Zolendronate Valve Leaflet
Experimental animal model of aortic stenosis Use of PET/CT on detecting calcification Aortic valve stenosis Control 1 st Department of Cardiology, Athens Medical School
Conclusions Aortic stenosis has become a fully treatable disease entity. TAVI has shown great long-term results. TAVI results > 10 years are eagerly awaited. Novel TAVI devices are constantly being developed. Newer indications for TAVI are aortic insufficiency and mediumrisk patients. The HEART TEAM should be involved when dealing with patients.
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Predilatation The DIRECT Trial The predilation in transcatheter aortic valve implantation Trial (NCT02448927) Patient evaluation by Heart Team 3 International TAVI Centers Hippokration Hospital: Core Lab TAVI 1:1 Randomization N= 170 BAV No-BAV Primary endpoint: Device success based on VARC-2 Secondary endpoint: In-hospital death, stroke, PPM, mortality
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12-month follow-up in patients diagnosed with infective endocarditis (IE) after transcatheter aortic valve implantation time 0 represents the time of IE diagnosis Ignacio J. Amat-Santos et al. Circulation 3/2015