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