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Angioplastica Coronarica dopo 40 anni dalla prima procedura
Prof. Carlo Di MarioCardiologia Interventistica Strutturale
AOU Careggi, Firenze
1977 Univ. Zurich 2017
The Legendary Live Courses in Zurich
PatrickSerruys
David Holmes
World’s First Coronary Angioplasty Patient
Fixed Wire Balloons 9 Fr Compatible
Trial Design
ORBITA Primary Endpoint: Not Met
LAD: 69%;QCA %AS: 84%; FFR:0.69
Why Class 0/1 patients pre-randomisation included?Too high baseline exercise capacity to detect differences4 complications (unintended PCI during FFR measurements)
Imbalance Prox/Ostial LAD/RCA disease: 53 v 36%Drop-outs: >10% v <1%Patients guessed more rightly to have received PCI: 49% v 63%
Power calculation wrong for the higher SD (464 pts)
RECOIL+
HYPERPLASIA
STENT
PTCA
RESTENOSIS
HYPERPLASIA
DES
BIODEGRADABLE
From POBA to IInd Generation DES
New Generation DES
Piccolo R, Giustino G, Mehran R, Windecker SThe Lancet. 2015;386:702–713
Byrne RA, Serruys PW, EHJ (2015) 36, 2608–2620
158 randomized clinical trials
Byrne RA, Serruys PW, European Heart Journal (2015) 36, 2608–2620
Neoatherosclerosis after first generation DES implantation (Cypher, 11 years)
NeoatherosclerosisCalcific and fibrotic plaque within a stent
Three ABSORB Stents Proximal LAD 3 Years Post-Implant
Chinese 45 Yrs Old Patient Presenting with no Symptoms; Questionable ST-T Changes Stress Test; Very Afraid Because of Negative BVS Press
3 ABSORB Stents Prox LAD 3 Yrs Post-Implant
Too Short v Too Late Resorption
Early Resorption< 1 year
LLL In scaffold (mm) 6m
Absorb®A 0.43 ± 0.37
AMS 1.08 ± 0.49
Dreams 1G 0.65 ± 0.50
Magmaris® 0.44 ± 0.36 BVS Cohort A – 6M
Absorb A : EuroInv 2009 Vol. 5 F15-F22J Am Coll Cardiol 2008;52:1616–20Dreams: Lancet 2013; 381: 836–44 Magmaris M. Haude TCT 2016
Late Resorption3 – 5 years
LLL In scaffold (mm) 6m
Absorb® B 0.15 ± 0.19
Fantom® 0.25 ± 0.40
Fortitude® 0.27 ± 0.41 (9m)
Rezolve: Eur Heart Journal (2012) 33, 16–25)Absorb B; B de Bruyne, TCT 2014 Magmaris M. Haude TCT 2016Fantom: Costa TCT 2016Fortitude: Colombo TCT 2016Raber et al. J Amer Coll Cardiol 2015:1901-14
44m VLscT Malapposed BVS struts surrounded by thrombus
Expansion 3.0 mm ABSORB with ostial LAD underexpansion with3.0x8 mm NC balloon at 16 Atm (A) and 3.5x10 mm Schwager
balloon at 26 Atm (B)
No Scaffold Fracture @ 28.0+3.4 Atm
A
B
A
B
A
B
Fabris, Di Mario et al, CCI 2015
Residual Underexpansion in a Napkin’s Ring Calcification
1,423 pts with stable angina; 342 with severe calcification (24%)
➢ At 2 years, TVF was 16.4% vs. 9.8%, p=0.001 predominantly driven by events in the first 48 hours and up to 1 year
➢ Of note, 2 year definite ST was 1.8% vs. 0.4%, p=0.02
Huisman J, van der Heijden LC et al Am Heart J 2016
Calcified Lesions: Current Devices
Calcified lesions: Intracoronary Lithotripsy
Presented by Brinton at CRT 2017, Washington
• E.H. 77 year-oldEgyptian patient
• Type 2 diabetesmellitus, systemichypertension, dyslipidemia
• Angina on effort(CCS III)
Lithotripsy Guided by IVUS
Severe calcified lesion
Lithotripsy Guided by IVUS
Napkin’s Ring
Lithotripsy Guided by IVUS
Shockwave balloon 3.5x12 mm
4 balloon inflations at 4/6 atm in the distal part of the lesion
4 balloon inflations at 4/6 atm in the proximal part of the lesion
Every energy erogation 10 seconds
Lithotripsy Guided by IVUS
Shockwave balloon 3.75x12 mm
8 energy erogations
Lithotripsy Guided by IVUS
Angiography post Shockwave
PTCA on LAD
DES implantation 3.5x38 mm (at 8 atm) Optimization with NC balloon 4.0x12 mm
IVUS longitudinal view
Final Angiographic Result
Final Angiographic Result
SYNTAX 2Presented ESC Barcelona 2017
Radial Versus Femoral Access in Invasively
Managed Patients with ACS:
Systematic Review and Meta-analysis
Conclusion: Major adverse outcomes significantly reduced with radial access.
Meta-analysis of 4 trials involving 17,133 pts compared radial vs. femoral access for interventions in ACS.
Andò G, et al. Ann Intern Med. 2015
Outcomes
RR for Radial vs. Femoral
Access P Value
Mortality 0.73 0.03
MACE 0.86 0.025
Major Bleeding 0.57 0.011
MATRIX: Radial Approach
Coprimary composite outcomes at 30 daysA) All-cause mortality, myocardial infarction, or stroke. B) all-cause mortality, myocardial infarction, stroke, or 3 or 5 BARC type bleeding
Valgimigli et al: Lancet. 2015 Jun 20;385(9986):2465-76
All-cause mortality, myocardial infarction, or stroke.
All-cause mortality, myocardial infarction, stroke, or 3-5 BARC type bleeding
Long-term P2Y12 inhibition
Bansilal et al, JACC 2018
PaPd
0 100 200 300 400 500 600 700 800 900
70
120
Pressure (
mm
Hg)
Time (ms)
Wave-freePeriod
Syntax II Study -PCI Protocol
Presented by Escaned at ESC Congress 2017, Barcelona
Presented by Escaned at ESC Congress 2017, Barcelona
I V U S
PaPd
0 100 200 300 400 500 600 700 800 900
70
120
Pressure (
mm
Hg)
Time (ms)
Wave-freePeriod
i F R/F F R
First coronary angiography: on 14 th September 1977First coronary angioplasty: on 16 th September 1977
Byrne RA, Capodanno D et al EuroIntervention 2017;13:621-624
Definition: Instantaneous pressure ratio, across a stenosis during the wave-free period, when resistance is naturally constant and minimised in the cardiac cycle
iFR = instantaneous wave-free ratio
Pa
Pd
0 100 200 300 400 500 600 700 800 900
70
120
Pre
ssure
(m
m H
g)
Time (ms)
Wave-free period
Sen S, ..., Davies J: J Am Coll Cardiol 2012;59:1392-402
Requires a Special Analyser
Cut-Off as Simple as FFR but Less Prone to Inaccuracies
4486 Patients
Author Name (Year)
MACE
Meta-Analysis IVUS Guided Studies IVUS Guidance vs Angiography Alone
IVUS guidance (n=12,499 pts) wasassociated with:
▪ Larger stents▪ Larger post-procedural MLD▪ More stents▪ Longer stents
▪ Significant lower rates of:▪ MACE (OR 0.74, p<0.001) ▪ Death (OR 0.61, p<0.001)▪ MI (OR 0.57, p<0.001)▪ ST (OR 0.59, p<0.001)▪ TLR (OR 0.81, p=0.046)
Ahn JM, et al. Am J Cardiol. 2014;113:1338-47
Meta-analysis of outcome after IVUS vs angiographic-guided DES implantation (n=26,503 pts from 3 RCT +14 observational studies)
0.01 100
Favors CAGFavors IVUS
0.1 1 10
Odd Ratio and 95% CI
Ahn JM et al. (2013)
Ahn SG et al. (2013)
Chen SL et al. (2012)
Chieffo A et al. (2013)
Claessen BE et al. (2011)
Hur SH et al. (2012)
Jakabcin J et al. (2010)
Kim JS et al. (2011)
Kim JS et al. (2013)
Kim SH et al. (2010)
Park KW et al. (2012)
Park SJ et al. (2009)
Roy P et al. (2008)
Witzenbichler B et al. (2013)
Yoon YW et al. (2013)
Youn YJ et al. (2011)
Random Effect Model
0.000
0.006
0.190
0.186
0.057
0.091
0.820
0.577
0.171
0.015
0.155
0.006
0.322
0.000
0.789
0.202
<0.001
p-Value
J Escaned et al EHJ 2017 0, 1-11
Syntax II Study -CTO Recanalisation
PEGASUS Multivessel
F.R., maschio, 90 anni
• Fattori di rischio CV: ipertensione, esposizione tabagica fino a dicembre 2016.
• BPCO in terapia con broncodilatatori• IRC in stadio IIIB• Anemia normocitica• FA parossistica in terapia con edoxaban• aneurisma fusiforme aorta addominale sottorenale (49 mm), ectasia a.
iliache comuni ed interne, stenosi critica all’ostio dell’a. femorale superficiale
• Dicembre 2016 ricovero per scompenso cardiaco• Febbraio 2017 EPA in corso di FA ad elevata fvm con rialzo TnI (picco 3.5
ng/mL)• Ecocardiogramma: funzione sistolica globale e regionale conservata,
stenosi aortica severa (Gmax 78 mmHg, G medio 39 mmHg).
• Stenosi critica calcifica del tronco comune coinvolgente la biforcazione di IVA e Cx.
• Stenosi critica ostiale 90% di Cx; stenosi subocclusivadi ramo marginale ben sviluppato
• Stenosi 70% calcifica di IVA prossimale
• Coronaria destra codominante, stenosi 30-40% prossimale
LM-LAD Disease
STS 20,58%
30/1 TAVI
30/1 TAVI
30/1 TAVI
Sapien3 26 mm
Accesso femorale destro
Decorso:- Non aritmie- Trasfusa 1 U di GRC per
anemizzazione- Buon risultato di TAVI,
insufficienza mitralica moderata
8/2 PTCA su TC-IVA-Cx
8/2 PTCA su TC-IVA-Cx
Stent medicati Xience3.5x38 mm su IVA, Xience 3.5x12 mm su ostio di Cx, Xience 4x18 mm su TC
POT 5.5 mm Ostium; KB 4.0 LAD + 3.0 LCx
Ottimo risultato angiografico finale
J Escaned et al EHJ 2017 0, 1-11
Syntax II Study –MACCE
Has in 40 Yrs Interventional Cardiology Reached Maturity?
..Yes, with many innovations bringing new interest
Titian, The Man’s Three Ages , National Gallery of Scotland , Edinburgh