Atherectomy in Complex Lesion -Real World Challenges and Data- · 2020. 9. 8. · Roy T, et al. J...
Transcript of 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
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Advanced ‘debulking’
options
Directional Atherectomy
Orbital Atherectomy
Jetstream
Rotational Atherectomy
Phoenix
Rotablation
‘Laser’
Various Forms of Atherectomy
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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
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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
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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
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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
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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
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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
PACCS score (1) (%) 8.6
PACCS score (2) (%) 14.2
PACCS score (3) (%) 39.5
PACCS score (4) (%) 31.5
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
Jetstream LL Registry
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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
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• 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
Jetstream LL Registry
Procedures
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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
Jetstream LL Registry
87.4%
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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
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Baseline 1 year
Clinical success* = 149/162 (92%)
* Improvement of ≥2 Rutherford
categories at follow-up
Jetstream LL Registry
Rutherford Class Improvement
Efficacy
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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.
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Lesion length is predictive for stent placement
Jetstream LL Registry
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
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Lesion length & PACCS score are both predictive for clinical success at follow-up
Jetstream LL Registry
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
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– 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
Jetstream LL Registry
Conclusions
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Thanks