Role of IVUS within a “Treat Optimally” Algorithm of Care

Fabrizio Fanelli, MD, EBIRProfessor of Radiology

Director Vascular and Interventional Radiology Department

"Careggi " University Hospital

Florence - Italy

Disclosure

• Consultant / Speaker / Proctor / Advisory Board

– Bayer

– Bolton

– Boston Scientific

– Cook

– Medtronic

– Shockwave Medical

– Philips

– W.L. Gore & Associates

DSA is still considered the gold standard image modality for the evaluationof the peripheral vessels

The correct degree of stenosis can not be assessedwith DSA

Bidimensional image visualization of DSA

Percent stenosis depends on the angle of imageintensifier and x-ray tube

Only one vessel diameter can be assessed withDSA

Volcano IVUS provides a 360 cross-sectional real-time view that improvesthe evaluation of the peripheral vessels and of the aorta

In case of obstruction definition of endoluminal orextraluminal recanalization is not always possiblewith DSA

Background

IVUS Advantages

Exact length measurements «pull back method»

Luminal diameter evaluation and cross-sectional area

Vessel morphology (plaque, thrombus, calcium)

Wall thickness

Degree of stenosis

Lesion type (Virtual Histology: fibrous vs. calcific)

Treatment guidance

Quick and accurate determination of true and false lumen

Improved alignment of the stent-graft with the renal arteries

Reduction of contrast media

Guide for correct stent deployment

Visions® PV .035

IVUS Catheter

J Vasc Surg 2002;35:316-23

52 pts. 71 limbs

Aorto-iliac occlusive disease treated with angioplasty and primary stenting

36 pts. 49 limbs DSA+IVUS

16 pts. 22 limbs DSA

Kaplan Meyer evaluation Primary Patency

3Y: 100% (IVUS) - 82% (DSA)

6y: 100% (IVUS) - 69% (DSA) p<.001

Secondary intervention: 5/22 limbs (23%) DSA

Diameter evaluation

What can you see through IVUS eyes?

Benefits of understanding vessel size

Guides device sizing to ensure precise wall apposition, drug delivery, and placement

Benefits of understanding plaque morphology

Understand plaque type and severity to help guide proper device selection

Benefits of understanding plaque geometry

Visualize plaque burden location for precise treatment

Benefits of understanding guidewire position

Confirm true lumen or sub-intimal guidewire location

Plaque morphology

Soft

Fibrotic

Calcific

Thrombus

CTOs

Guidewireposition

True lumen

Sub-intimal

Benefits of understanding vessel size

Guides device sizing to ensure precise wall apposition, drug delivery, and placement

Benefits of understanding plaque morphology

Understand plaque type and severity to help guide proper device selection

Plaque geometry

Eccentric

Concentric

Benefits of understanding plaque geometry

Visualize plaque burden location for precise treatment

Benefits of understanding guidewire position

Confirm true lumen or sub-intimal guidewire location

Vessel size

Vessel diameter

Lumen diameter

Plaque burden

Plaque morphology

Soft

Fibrotic

Calcific

Thrombus

CTOs

Guidewireposition

True lumen

Sub-intimal

Flow Evaluation

Vision PV .014 catheter

Philips

before treatment

Post

3.0mm Stellarex(Philips)

Eagle Eye catheter

Philips

ChromaFlo

Highlights blood flow red for easy

assessment of stent apposition,

lumen size and more. Helps identify

branches, dissections and plaque in

bifurcations.

VH IVUS

Colorized tissue map of plaque

composition with automated lumen

and vessel measurements.

Proprietary spectral analysis

technique to classify plaque into 4

tissue types.

Safety and effectiveness of VH IVUS for use in the characterization

of vascular lesions and tissue types has not been established©2018 Koninklijke Philips N.V. All rights reserved. Some or all products manufactured by Spectranetics, a Philips company. Approved for external distribution. D045587-01 092018

Visions PV catheters• Only full suite of advanced imaging catheters

Pre Post Lithoplasty

Plaque Geometry

Vision PV .018 catheter

Philips

Heavy calcified lesion (grade 4 b) SFA

IVUS changed treatment plans in 79% of cases

Spark I, Allan R. The role of IVUS in peripheral interventions. Charing Cross. 2018. London, UK. N=47; Not indicative of future performance

67 y M

Diabetic, Hypertension, Ex smoker

Previous PTA + stent Rt SFA

Rt severe claudication (<50 mt)

Vision PV .018

catheter

Philips

6 mm Stellarex(Philips)

5 mm PTA

Vision PV .018 catheter

Philips

6 mm Stellarex(Philips)

Vision PV .018 catheter

Philips

©2018 Koninklijke Philips N.V. All rights reserved. Some or all products manufactured by Spectranetics, a Philips company. Approved for external distribution. D045587-01 092018

1. Dippel et al. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for

Treatment of FemoropopliTEal In-Stent Restenosis). JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):92-101

2. Davis, Thomas et al., Safety and effectiveness of the Phoenix Atherectomy System in lower extremity arteries: Early and midterm outcomes from the prospective multicenter EASE study. Vascular. September 27, 2017,

DOI: 10.1177/1708538117712383.

3. Kiesz RS, Scheinert D, Peeters PJ, et al. Results from the international registry of the AngioSculpt Scoring Balloon Catheter. J Am Coll Cardiol. 2008;51:10(suppl B);75.

4. Mathews S. NCVH. 2018. ILLUMENATE Pivotal Stellarex DCB IDE study 2-year outcomes. May 30, 2018. New Orleans, LA.

*Bare metal stent

Treat optimallyPhilips delivers versatility to treat the majority of patients

Turbo-Elite and Turbo-Power

laser atherectomy

Clinically proven ablation in all

lesion types above and below the

knee; indicated for ISR*1

Phoenix atherectomy system

Front-cutting mechanical

atherectomy for treating mixed

morphologies with low risk of

embolization2

AngioSculpt scoring balloon

Reduces risk of flow limiting

dissections including in calcified

lesions3

Vessel prep Prepare multiple lesion morphologies, locations

and characteristics

Stellarex drug-coated

balloon

Durable treatment effect in

common to complex patients

with a low drug dose

Only DCB reporting durable

2yr patency in severely

calcified lesions4

Definitive treatmentTreat lesions without leaving metal behind

CrossingCross your toughest lesions

Quick-Cross catheter

Number one selling

support catheter

Pioneer Plus catheter

Only IVUS-guided re-

entry catheter

Eagle Eye catheter - Philips

Angiosculpt

5x100 mm

Philips

Stellarex DCB

5mm

Philips

Stellarex DCB

Ø 5 mm

(Philips)

Vision PV .018 catheter

Philips

IVUS can be considered a valid tool in daily activity

As interventional procedures are becoming increasingly complex,

success is related to the degree of accuracy or to the guiding system

employed

IVUS gives a more precise evaluation of the peripheral arterial

diseased segment

It offers an objective assessment of plaque morphology

It can improve the technical success of all endovascular procedures

The role of IVUS is to «guide» peripheral interventions

Complete integration with other devices, especially re-entry devices

Conclusions

fabrizio.fanelli@unifi.it