atherectomy in complex lesion -real world challenges and data- · 2020. 9. 8. · roy t, et al. j...

Atherectomy in Complex Lesion

-Real World Challenges and Data-

Prof. Martin Andrassy, MD

FSK Bruchsal, Germany

LINC LIVE webinar 02.09.2020

DisclosureSpeaker name: Martin Andrassy

I have the following potential conflicts of interest to report:

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

X I do not have any potential conflict of interest


Advanced ‘debulking’

options

Directional Atherectomy

Orbital Atherectomy

Jetstream

Rotational Atherectomy

Phoenix

Rotablation

‘Laser’

Various Forms of Atherectomy


Atherectomy removes

atherosclerotic / calcific

tissue similar to surgical

techniques, resulting in

lumen gain without

barotrauma

Decreasing the chance for

dissection,

avoiding additional stent

placement

Potentially simultaneously

increasing drug delivery to the

vessel wall

Facilitating low pressure

balloon angioplasty

Advantages of Atherectomy


Lesion characteristics

Calcium¹ In-stent

restenosis²

Chronic total occlusions (CTOs)³

Thrombus4

1. Image Courtesy of Dr. Nick Shammas

2. Image Courtesy of Dr. Thomas Pow3. Image Courtesy of Dr. Robert Crawford

4. Image Courtesy of Dr. Ali Amin

PAD Presents Many Clinical Challenges


Roy T, et al. J Endovasc Ther. 2016

Heterogenous Plaque Morphology• CTO plaques may include fat, thrombus, soft

tissue, hardened tissue, and calcium

Popliteal Artery Calcified CTO

MR

IH

isto

log

y

Calcium

Thrombus

Fat

Soft tissue

(vessel wall

reference)

Popliteal Artery “Hard” CTO

Micro-CT

Dense collagen


Younger patients.

Preserve bypass landing zones.

Occlusive lesions that can be passed by

an intraluminal approach (antegrade or

retrograde).

Complex TASC C/D, strongly calcified

non-occlusive lesions (PACSS score ≥3).

Long diffuse non-occlusive disease.

Less complex lesions with low or no

calcification grade

Occlusive lesions that cannot be

passed by an intraluminal approach.

Evaluating patient characteristics

and lesion anatomy, complexity and

calcification

Lesions, where stent placement is

allowed or perforation may be difficult

to handle (iliac arteries).

No-stent zones (common femoral and

popliteal artery).

Consider atherectomyVascular & Endovascular

Reviews 2019LINC LIVE webinar 02.09.2020

Overview

ObjectiveObserve the treatment effects of the JetstreamTM Atherectomy System combined

with DCB (InPact Admiral) in peripheral arterial disease of the femoropopliteal

arteries

Subjects

162 patients with femoropopliteal lesions

Key inclusion criteria:

• Rutherford category of 1-5

• de novo or restenotic (non-stent), ≥70% stenosis or occlusion, lesion length > 15cm

• ≥1 patent runoff vessel

Endpoints

Primary:

• Binary restenosis at 12 months (DUS-derived peak systolic velocity ratio >2.5)

Secondary:

• 30-day freedom from MAEs (amputation, death, TLR/TVR, MI, distal embolization

that requires a separate intervention or hospitalization)

• Procedural success (≤30% residual diameter stenosis post-procedure)

• Rutherford category improvement (reduction ≤1 category)

• ABI improvement (increase ≥ 0.10 from baseline)

ABI, ankle-brachial index; DUS, duplex ultrasound, MAE, major adverse event; MI, myocardial infarction; TLR/TVR, target lesion/vessel

revascularization

Jetstream LL Registry


Patient characteristics All-comers (n=162)

Age (yrs.) 72,6 ± 4,5

Male gender 95/162 (59%)

Art. Hypertension 132/162 (81%)

Hyperlipidemia 117/162 (81%)

Diabetes mellitus 99/162 (63%)

Active smoking 40/162 (25%)

Heart failure 24/162 (15%)

History of CAD 84/162 (53%)

History of stroke 29/162 (18%)

Chronic renal failure 16/162 (16%)

Body mass index (kg/m²) 27.1 ± 2.58

Mean Rutherford category 3,7 ± 0.6

Rutherford category III 66/162 (41%)

Rutherford category IV 82/162 (51%)

Rutherford category V 14/162 (10%)

Baseline CharacteristicsJetstream LL Registry


Lesion characteristics All-comers (n=162)

Lesion length (cm) 24.2 ± 4.8

Total occlusions (%) 51

Combined lesions* (%) 26.5

PACCS score (0) (%) 6.2





Reference lumen diameter (mm) 6.0 ± 0.4

Atherectomy run-time (min) 6.3 ± 1.0

Blades-down run-time (min) 3.7± 0.8

Blades-up run-time (min) 2.7± 0.8

Scoring balloon angioplasty (%) 4.9

Distal protection device used (%) 11.7

Proposed Peripheral Arterial Calcium Scoring System (PACSS):

grade 0 no visible calcium

grades 1 and 2unilateral calcification

<5 or ≥5 cm

grades 3 and 4bilateral calcification

<5 or ≥5 cm, respectively

* Involvement of either the CFA or PA

Lesion Characteristics



Baseline After

Jetstream

After Jetstream

+ adj. treatment

p < 0.001

p < 0.001

• Residual stenosis <50% only by atherectomy and without adjunctive therapy.

** Residual stenosis <30% after atherectomy plus adjunctive therapy.

ProceduresJetstream LL Registry


• 12 patients (7.4%) received adjunctive stents

• Stent placement performed at operator’s discretion

• Embolic protection used in 11.7% of cases

Post-treatment stenosis estimate, mean ± SD

Overall(N=232 lesions)

Non-Stent(N=210 lesions)

Stent(N=22 lesions)

Post-Jetstream 38.4% ± 9.5% 28.5% ± 12.2% 48.8% ± 22.0%

Post DCB Treatment 5.0% ±4.1% 4.5% ± 11.7% 5.6% ± 8.2%

Total Jetstream run time: 6.3 ± 1.0min

Number of Passes

Blades Down: 3.7 ± 0.8

Blades Up: 2.7 ± 0.8


Procedures


Efficacy• 13.6% overall restenosis rate at 12 months

• 87.4% overall freedom from TVR/TLR

Overall Population(N=76)

Non-Stent(N=150)

Stent(N=12)

Binary Stenosisa, % (n/N)

30 Days 1.9% (3/162) 2% (3/150) 0.0% (0/12)

12 Months 13.6% (22/162) 12% (18/150) 8.3% (1/12)a DUS-derived PSVR >2.5


87.4%


p < 0.001 p < 0.001

p < 0.001

Baseline ABI 30 days ABI 1 year ABI

0.4+0.1

0.9+0.2

0.8+0.2

Jetstream LL Registry Efficacy


Baseline 1 year

Clinical success* = 149/162 (92%)

* Improvement of ≥2 Rutherford

categories at follow-up


Rutherford Class Improvement

Efficacy


30 Days (N=162)12 Months

(cumulative; N=162)

MAE 2.3% 11.2%

Death 0% 3.1%

Amputation 0% 3.7%

Myocardial infarction 0% 4.3%

SafetyJetstream LL Registry

Complications

All-comers

(n=162)

Perforation or dissection 0 (0%)

Peripheral embolization** 10 (6.2%)*

* In all 10 cases, minor embolization (all remaining asymptomatic) were observed without peri-procedural vessel

occlusion. Embolized tissue could be retrieved in all cases by catheter aspiration.


Lesion length is predictive for stent placement


Odds ratio 95% CI P-values

Male gender 1.3 0.35 – 4.7 NS

Diabetes mellitus 0.35 0.10 – 1.21 NS

PACSS score 1.09 0.55 – 2.15 NS

Lesion length (mm) 1.2 1.04 – 1.41 0.02


Lesion length & PACCS score are both predictive for clinical success at follow-up


Odds ratio 95% CI P-values

Male gender 0.4 0.09 -1.7 NS

Diabetes mellitus 0.25 0.05 – 1.28 NS

PACSS score 0.32 0.12 – 0.86 0.02

Lesion length (mm) 0.79 0.67 – 0.93 0.006


– Rotational atherectomy can be applied in long, calcified, (non-)occlusive

infrainguinal lesions effectively and safely

– Adjunctive stent placement was only necessary in a minor proportion of

patients

– Lesion length is predictive for stent placement

– RF Category - and ABI- index improvements were significant at 12 months FU

– PACCS score and lesion length are both predictive for clinical success


Conclusions


Thanks

atherectomy in complex lesion -real world challenges and data- · 2020. 9. 8. · roy t, et al. j...

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