Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP...
Transcript of Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP...
![Page 1: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/1.jpg)
Shockwave Lithoplasty - Indications And Results: Use In Combination With DCBs
Gunnar Tepe MDRoMed Rosenheim
![Page 2: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/2.jpg)
Disclosure
• I have the following potential conflicts of interest
to report:
• Shockwave Medical study support
![Page 3: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/3.jpg)
Lithoplasty System Vascular Applications
The Shockwave Medical Lithoplasty System is
intended for lithotripsy-enhanced balloon
dilatation of lesions, including calcified lesions,
in the peripheral vasculature, including the iliac,
femoral, ilio-femoral, popliteal, infra-popliteal,
and renal arteries. Not for use in the coronary
or cerebral vasculature.
Post LPPre LP Post LPPre LP Post LPPre LP
CFA SFA/POP BTK
![Page 4: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/4.jpg)
Goal of Lithoplasty
• Obtain a better lumen with PTA
• Avoid stents
• Overcome the main limitation of DCB: severe calcium
![Page 5: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/5.jpg)
Internal Use Only
DISRUPT PAD and BTK Patient Demographics and Angiographic Findings
Patients Included
Vessels Femoral/Popliteal Arteries Tibial/Peroneal Arteries
Rutherford 2 33.7% (32) -
Rutherford 3 65.3% (62) 20.0% (4)
Rutherford 4 1.1% (1) 5.0% (1)
Rutherford 5 - 75.0% (15)
CalcificationModerate 44.2% (42) 52.4% (11)
Severe 54.7% (52) 47.6% (10)
Angiographic
Findings
RVD (mm) 5.3 3.2
Lesion length 71.9 52.2
Calcified length 92.5 72.1
CTO 18.9% (18) 9.5% (2)
DISRUPT PAD I35 subjects, 3 sites
+
DISRUPT PAD II60 subjects, 8 sites
DISRUPT BTK20 subjects, 3 sites
21 lesions
DISRUPT PAD & DISRUPT BTK categorized calcified lesions as per PARC definitions. Both studies utilized independent core labs and clinical events committees.DISRUPT BTK data based on European studies.
DISRUPT BTK assessed Lithoplasty performance in a difficult-to-treat CLI population
![Page 6: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/6.jpg)
Internal Use Only
DISRUPT PAD and BTK Safety & Effectiveness
Safety
Dissections1% (1) Grade D or greater
1% (1) stent placed0 Grade D or greater
Embolization0 Embolic Events
8% EPD Usage0 Embolic Events
Perforations, abrupt
closure, slow/no reflow
or thrombosis
0 Complications 0 Complications
EffectivenessResidual Stenosis 23.8% 26.2%
Acute Gain 2.9mm 1.5mm
Follow-Up
30 days100% Freedom from TLR
100% Patency100% Freedom from TLR
0% MAE (death, amp. or MI)
6 months96.8% Freedom from TLR
76.7% Patency-
DISRUPT PAD I35 subjects, 3 sites
+
DISRUPT PAD II60 subjects, 8 sites
DISRUPT BTK20 subjects, 3 sites
21 lesions
DISRUPT PAD & DISRUPT BTK categorized calcified lesions as per PARC definitions. Both studies utilized independent core labs and clinical events committees.DISRUPT BTK data based on European studies.
Lithoplasty has a strong safety and effectiveness profile above- and below-the-knee
![Page 7: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/7.jpg)
Severe Calcium Acts as a Barrier to DCB
Fanelli F et al. Calcium Burden Assessment and Impact on Drug-Eluting Balloons in Peripheral Arterial Disease. Cardiovasc Intervent Radiol (2014) 37:898–907.
![Page 8: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/8.jpg)
CASE 1
![Page 9: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/9.jpg)
Pre Intervention Images
![Page 10: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/10.jpg)
After Treatment with Turbohawk
![Page 11: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/11.jpg)
Hawk Reocclusiontreated with
Viabahn
![Page 12: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/12.jpg)
New restonosistreated with Lithoplasty
![Page 13: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/13.jpg)
Plus DCB
![Page 14: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/14.jpg)
Lessons Learned
Atherectomy failed after 6 months
Lithoplasty + DCB with sustained benefit after 6 and 12 months in severe calcification
![Page 15: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/15.jpg)
CASE 1
![Page 16: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/16.jpg)
Treatment with DCB
![Page 17: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/17.jpg)
Follow up
6 months 12 months 36 months
![Page 18: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/18.jpg)
Lithoplasty
![Page 19: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/19.jpg)
Plus DCB
![Page 20: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/20.jpg)
After Lithoplastyand after DCB
![Page 21: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/21.jpg)
Lessons Learned
In DCBs restenosis occurs especially if calcium is present
Lithoplasty + DCB might be useful
Follow-Up 6 and 12 months
![Page 22: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/22.jpg)
Next Steps in Shockwave Lithoplasty Clinical Development
Lithoplasty as primary therapy
Results:
• Low rate of vascular complications
Provisional stenting (1.1%)
• Consistent effectiveness
High acute gain (3.0 mm)
Low residuals stenosis (23.8%)
Sustained 6 month results
DISRUPT PAD I DISRUPT PAD II DISRUPT PAD III
Combination therapy
• Goal is to assess the optimal therapy to dilate heavily calcified lesions.
• All patients who do not receive a stent will be treated with a drug-coated balloon.
![Page 23: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/23.jpg)
Disrupt PAD III Study Design
Study Design: Randomized study of the Shockwave Medical Peripheral Lithoplasty System with DCB versus standard balloon angioplasty with DCB to treat moderate and severely calcified femoropopliteal arteries (Disrupt PAD III).
Objective: The objective is to assess the optimal therapy to dilate heavily calcified lesions with Lithoplasty® versus traditional angioplasty, in achieving less than 30 % stenosis without the need for a stent. In addition, all patients who do not receive a stent will be treated with a drug-coated balloon.
Treatment arm (N=167)Lithoplasty + IN.PACT DCB
Control arm (N=167)PTA +
IN.PACT DCB
334 subjects
45 global sites
Randomization 1:1
24 months follow-up
Moderate and severely calcified femoropopliteal arteries
Rutherford 2 to 4
RVD 4-7, stenosis ≥70%,
Lesion length 5–18 cm occlusive or ≤10 cm CTO
![Page 24: Shockwave Lithoplasty - Indications And Results: Use In ... · Pre LP Post LP Pre LP Post LP Pre LP Post LP CFA SFA/POP BTK. Goal of Lithoplasty •Obtain a better lumen with PTA](https://reader030.fdocuments.us/reader030/viewer/2022040808/5e4b5cd7ac3c9d78b274c8ec/html5/thumbnails/24.jpg)
• High acute gains and low residual stenosis determine outcomes and are
difficult to achieve in calcified lesions
• Calcified lesions limit effectiveness of drug-coated balloons
• Calcified lesions respond poorly to treatment and require high use of stents
• DISRUPT PAD III is the largest, randomized study in a difficult to treat, calcified
patient population.
• The goal is to provide level one evidence on the best treatment strategy for
calcified lesions in a leave nothing behind strategy
Summary