Publications_V4 презентация

© Copyright Straub Medical AG

09.06.2017

ischemia of the limbs is still one of the most frequent reasons for amputation.9

NOTE: compared to PTA and stent implantation for arterial occlusive diseases, atherectomy offers advantages of eliminating stretch injury on arterial walls and reducing the rate of restenosis. 31

device 45
Efficient, quick, easy to handle, and safe tool without expensive preparations for the treatment of acute, subacute or even chronic peripheral arterial thromboembolic occlusions. 4, 7, 36
Modern peripheral debulking device that combines mechanical thrombus fragmentation and removal of the material using negative pressure 9, 36

results and rapid restoration of blood flow in the treated vessels. 46

Peripheral Vascular Disease

09.06.2017

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Several case reports show a variety of effective treatments (case reports presentation):
Subclavian and axillary arteries.9
In-stent occlusion
SFA-POP chronic occlusion 25
Dialysis access graft
Stent graft

Restenosis / In-Stent Reocclusion
Venous and Synthetic Bypass occlusions
Visceral artery occlusion
Upper extremity artery occlusion

Combination therapy:
Rotarex®S plus DCB

as PTA (with or without stenting) produce trauma: 30
Barotrauma (vessel overdilation)
Damage to endothelium
Rupture of the internal elastic lamina
Medial injury with consecutive wall inflammation (“deep injury”)

Vessel injury results:
Inflammation
Vessel recoil
Negative remodelling
Development of neointimal hyperplasia

Formation of a complex restenotic lesion with different morphology than the novo lesions. 29

all detachable material from acute, subacute and chronic occlusions.1, 7
Shows convincing long-term results.1
Exposes the culprit lesion, if any, for focused treatment.

RESULTS

Up to 90% amputation-free survival after 12m. 4,5,6,7, 36
Up to 97% procedural technical success rate. 1
Up to 94% clinical success. 2,4,5,6,7, 36

Efficient 4, 7
Safe device 4, 7
Simple handling 9
Short intervention time 9

REDUCES

The need for additional treatments. 1
The need for thrombolysis in a significant portion of patients.1
Bleeding complications
Costs (e.g. of monitoring patients at the ICU). 4, 9

Straub Medical AG

University of Leipzig (single-center)
8 years experience with rotational mechanical debulking
Treatment of acute and subacute lesions in lower limbs
Procedural technical success rate of 97.7%
Mean lesion length 159 mm (range 22-279 mm)
Rotarex®S sole treatment in 161 patients
Stenting was necessary in 28.4%. Nevertheless, 21.7% was needed spot (focal) stenting.
By using Rotarex®S as the primary treatment, the thrombolysis rate decreased to less than 14%

Straub Medical AG

Excellent immediate results 97.7% and satisfactory long-term results. Consistent with the results of Stanek et al2 (65 patients with acute and subacute occlusions), which reported immediate successful recanalization in 95%.
Similar results regarding technical success, amputation and embolization rates comparing the results reported by Wissgott et al3 (265 patients treated with Rotarex®S)
Rotarex®S mechanical debulking represents a minimally invasive option for rapidly recanalizing, amongst others, thrombus-containing lesions.
Treatment with Rotarex®S resulted in clinical and hemodynamic improvement in the majority of patients.
Reduced the need for thrombolysis in significant proportion of patients.
Rotarex®S is an effective and safe modality for treating acute and subacute or even some chronic peripheral arterial thromboembolic occlusions.
Excellent immediate results 97.7% and satisfactory long-term results.
After 12m a promising TLR 10.1% - Showing superiority of Rotarex®S debulking to all other devices

Medical AG

Indirect comparisons of the relevant endpoint (amputation-free survival after 12 months) between surgical thromboembolectomy and percutaneous thrombectomy systems revealed better results with the mechanical treatment procedure than with local thrombolysis or surgical intervention (see table on next slide). This indirect comparison of relevant end point data clearly shows the effectiveness and superiority of the pure mechanical approach.
Vascular surgery-based thromboembolectomy, which provides no additional benefits in terms of efficacy, safety or hospital stay, and catheter-directed thrombolysis with its potentially life-threatening complications should only be considered in cases of failed or incomplete mechanical removal.
Healthcare systems economy: the mechanical approach is superior to surgery; it can be performed rapidly and easily without expensive preparations.

mechanical thrombectomy (rotational thrombectomy) 4

09.06.2017

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stents are implanted annually worldwide. 30% to 40% of the patients will present ISR. 28

The main problem with the treatment of arterial stenoses by PTA and/or stent implantation is the relatively high restenosis rate.8

Because they are muscular (distributing) arteries, the femoropopliteal have higher rates of restenosis after percutaneous interventions. Three-year patency rates of lesions that have been stented ranges from 58%-66%.10

Stent implantation has demonstrated an advantage over PTA alone. However the benefit was not always significant. 21, 22

Stent fracture after femoral stenting leads to a higher in-stent restenosis and reocclusion rate.10

ablation of neointima.
The restenosis rate is significantly reduced.8
High patency rates in combination with PTA.7
The treatment time with Rotarex®S alone is short.
Recanalization of in-stent reocclusion is safe and effective. No risk of perforation. 8

Ideal therapy option:

Medical AG

Rotarex®S valuable therapy alternative for in-stent reocclusions
Technical success rate 97.4%
Low rate of restenosis at 12 months appears to be promising.
When handled properly, Rotarex®S avoids the embolization of any occlusion material.
Reduces the necessity for additonal use of balloons and/or stents, and reduces the lengths required.
The cost of using the system are covered in several reimbursement systems.

6 months follow-up: TLR 7.9% (6 of 76 patients)
12 months follow-up: TLR 10.5% (8 of 76 patients)

Total Restenosis Rate
after 12m: 18.4%

Copyright Straub Medical AG

Copyright Straub Medical AG

AG

Acute and subacute ischemia of the legs in femoropopliteal bypass occlusion is a dramatic situation that endangers the survival of the limbs. 12

Local lysis has been established as an alternative measure in addition to the established vascular intervention (Fogarty, endarterectomy, another bypass operation). 12 But do we really need lysis? (see presentation Bruno Migliara!!!!) 41

Pure mechanical therapy has been proven as an additional therapy option with less safety risks and more benefits.12

success rate 100% 82%
Complications - -

6 months
follow up 13

12 months
follow up 12

12 venous bypasses
10 PTFE bypasses
Length of the occlusion in femoropopliteal bypass 28+/- 10 cm
Local lysis in 4 patients

Recommendation: Use of 8F Rotarex®S System in the indication of femoropopliteal bypass occlusion in order to reduce the thrombus load as much as possible and to avoid any additional lysis.12

│ © Copyright Straub Medical AG

Length of the occlusion 24-34 cm
Local lysis in 4 patients
Technical success rate 97.6%
2 complications: 1 distal embolization, 1 small perforation at the distal anastomosis
Amputation free survival rate 100%

Retrospective study (42 patients)
34 venous bypasses (81%)
8 PTFE bypasses (19%)

31 acute (<14 days) (73.8%)
11 subacute (14-42 d) (26.2%)

(SMA) embolism is a rare abdominal emergency that commonly leads to bowel infarction and has a very high mortality rate (in-hospital 59 to 93%) 36, 37

Treatment of choice: laparotomy with thrombectomy and percutaneous thrombectomy 37

The two main percutaneous methods are:
Aspiration thrombectomy, in which thrombus is removed by suction
Mechanical thrombectomy, using different automated devices to fragment and remove embolus

superior mesenteric artery embolism 37

Percutaneous Mechanical Thrombectomy showed good results with dramatic improvement of symptoms present immediately in all patients.
No post procedural complications were present in our patients probably due to absence of any additional pharmacologic lysis.

Advantages of mechanical thrombectomy in SMA:

Rapid and effective removal of large thrombus
No need for local thrombolysis and its minimal invasiveness, thus avoiding the complications associated with surgery.

AG

Proximal subclavian artery occlusion is relatively rare and usually asymptomatic.
In the rare symptomatic cases, surgical or endovascular intervention is indicated:
Fogarty balloon thrombectomy: technical problems and complications can occur. 24
Subclavian bypass operation: open surgery.24
Local lysis infiltration: time-consuming and expensive, requires ICU and angiograms.24
Thrombectomy devices: minimization of bleeding complications, less invasive and time-efficiency, short hospital stay.24, 26

Conclusion: Rotational thrombectomy together with optional local low-dose lysis in an acute occluded subclavian artery is a promising therapeutic option. 24

restenosis rate is the main problem with treatment of arterial stenosis and occlusions.
Restenosis can occur in 40-60% of patients. 22
Regardless of all the technological progresses in balloons, the high rate of restenosis is problematic. 22, 23
DCB is an effective treatment of short ISR lesions, but not efficient in more complex lesions.30
The DCB seems to be a prevention of restenosis at the six-month follow-up.22
THUNDER and PACIFIER study concluded that the restenosis rate is reduced if DCB are used.22

Rotarex®S + DCB: Hemodynamic success demonstrated. 22
Rotarex®S + DCB: is safe and effective and with promising results. 8, 22


Conclusion:
Early data suggest debulking and modifying the plaque before DCB treatment seems to be of key importance in more complex ISR lesions.30

technical success
Significant increase in the ABI




89.7% no further therapy needed
3 patients (10.3%) required stent implantation due to residual stenosis
A significantly lower rate of restenosis was noted (6.9%) after 6m

Conclusion:
Pre-DCB thrombus removal is recommended so the drug released during the inflation of the balloon is taken up by the vessel wall. 22

catheters is still the surgical standard procedure to reopen thrombotic occlusions. It is however very invasive and produces bad mid term results 48

This should be changed!

Vascular injuries 32

Arterial rupture and dissection are 60% of acute complications.
Accelerated atherosclerosis
High re- occlusion rate
Intimal and medial hyperplasia

Copyright Straub Medical AG

The superiority of Rotarex®S is demonstrated in the ability to remove even organized thrombi with a higher technical success rate. 8

The Rotarex®S group shows a significantly higher amputation-free survival rate compared to local lysis. 8

example and the number is an approximation computed by SMAG research
OP = 1 minute cost of cath lab time, b = cost of bed stay, i = cost of ICU bed stay, ra = Rotarex/Aspirex list price, a = AngioJet catheter price, x = number of vials used, t = cost of a vial of thrombolysis

rotational cutter with aspiration capacity that has been shown to cut and remove atherosclerotic and restenotic tissue. 34

What about Rotarex®S ?

Different studies have proved:

Up to 97% procedural technical success rate. 1
Up to 94% clinical success. 2,4,5,6,7

TLR rates after only 6 months!
- Compare with the Scheinert Data
- Look at Wissgott Publication

low stent rate peri-interventionally and the low restenosis rate after 12 months, with a significantly longer lesion length, indicate a better effectiveness of the Rotarex®S system as a whole. 35

is complex and cost-intensive because patients must stay on ICU for several days after procedure. 14

flow is restored much faster with Rotarex®S

Rotarex®S significantly shorter

become a viable alternative to intra-arterial thrombolysis for treatment of acute infrainguinal occlusion.
Aim of this study was to evaluate the safety and effectiveness of two different systems.

the TVR / TLR rates only after 12 months !!!!!!!!

controlled physician-initiated trial
40 patients
To evaluate the safety and efficacy of recanalization of acute and subacute (up to 12 weeks) femoropopliteal stent occlusions with the Rotarex®S catheter.

DVT results in long-term morbidity (PTS – Post Thrombotic Syndrome).15
40%- 50% of patients with DVT develop PTS. 15, 40
Management of acute thrombosis should not only focus on the prevention of acute complications (propagation or embolization of the clot), but also on preventing PTS. 15
Residual obstruction combined with valve dysfunction leads to chronic venous insufficiency15
Open vein hypothesis: PTS is higher in patients with residual thrombus after 6m of anticoagulant therapy than in patients with complete recanalization 15, 16, 17, 18

(ACCP 2012, DGA)
Compression therapy (early stage)15
Anticoagulation (acute phase). (LMWH,OAC, NOAC)15

Complications of the anticoagluation therapy 15
Bleeding (Haemorrhage)
Heparin induced Thrombozytopenia (Reduction of the platelets)
Anticoagulation alone does not eliminate venous obstruction in a large part of patients, and venous thrombosis remains

Prognosis:
Incidence of a Post-thrombotic Syndrom after 4-5 years in 69% of the patients

local lysis therapy
Only for patients < 50 years with DVT < 7d

Complications:
Bleeding (Haemorrhage)
Allergic reactions of the heart and circulatory system in 40% of the patients (38% mild, 2% severe)
Increased risk of PE

Prognosis:
Endogenous fibrinolysis is often incomplete w/ more than 30% of patients presenting w/ residual thrombosis after 3m of anticoagulation 15
Incidence of a Post-Thrombotic Syndrom after 4-5 years in 36% of the patients

fragmentation and removal by PTA, Basket, Aspiration
Pharmacomechanical thrombolysis
Trellis (Covidien)
AngioJet (Boston Scientific)
EkoSonic (BTG)

Mechanical thrombectomy devices
Aspirex (Straub Medical) – Thrombus aspiration
Trerotola (Teleflex) – Thrombus maceration
Cleaner 15/XT – Thrombus maceration

thrombus removal strategies for acute DVT: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum.19

We further suggest the use of early thrombus removal strategies in ambulatory patients with good functional capacity and a first episode of iliofemoral DVT of <14 days in duration (Grade 2C) and strongly recommend their use in patients with limb-threatening ischemia due to iliofemoral venous outflow obstruction (Grade 1A).

We suggest pharmacomechanical strategies over catheter-directed pharmacologic thrombolysis alone if resources are available and that surgical thrombectomy be considered if thrombolytic therapy is contraindicated (Grade 2C)

What about mechanical thrombectomy strategies without lysis?
Aspirex®S is not yet cleared for sale in the USA.

linked to thrombolysis and bears a similar risk profile
Relatively long intervention times
Mostly incomplete thrombus removal
Results often in Haematuria (Hemoglobinuria)
Induces Bradyarrhythmia

Anticoagulation only
1980´s Systemic Thrombolysis
1990´s Catheter Directed Thrombolysis
2000´s Pharmacomechanical Thrombolysis
NOW Mechanical Thrombectomy ?!!

Aspirex®S

endovascular treatment group had a shorter duration of hospitalization, greater reduction of leg edema and better subjective improvement of symptoms while bleeding complications did not occur more frequently.15


Deep vein thrombosis
Native (vein) bypass occlusions
Synthetic bypass occlusion

AG

2009 - 2014 (38 consecutive pt.)

N=51

Efficacy of mechanical thrombectomy in forearm haemodialysis grafts (Samuel Heller, Prague, CZ)

thrombectomy in forearm haemodialysis grafts (Samuel Heller, Prague, CZ)

one hour), single session
Comparable to other devices, only 6F OTW
Not sending 10 cc of clot into pulmonary circulation
No risk of tPA administration
Rotarex®S seems to be more effective than Aspirex®S

Aspirex®S / Rotarex®S for thrombosed AVGs

Efficacy of mechanical thrombectomy in forearm haemodialysis grafts (Samuel Heller, Prague, CZ)

AG

Is effective in venous thrombus removal – even in more organized thrombus
restores vein patency fast and effective in upper and lower limb
preserves valvular function
prevention of PTS
low risk, less adverse effects – safe
reduce lysis-time and drug
reduce ICU stay
„one stop shopping“

6 m patency 90%
able to remove material and to create channel
multifunctional
not only restricted to classic iliofemoral DVT
No RCT date, only registry data
IVUS, IVC-Filter
PE

No bleeding complications

Aspires®S / Rotarex®S
Shortest hospital stay, no need of ICU

USCDT does not have any apparent clinical benefits over CDT alone.
Similar results with the randomized study by Engelberger et al43 - No differences in thrombus load, nor in vessel patency and incidence pot PTS after 3m after treatment.

42

Aspirex®S
to collect further data proving safety and efficacy of the Aspirex®S device

to monitor development of the venous scores
to assess avoidance of a PTS by the treatment
to monitor post-interventional anticoagulation regimes

Capturex®
will be used at physician‘s discretion (enrollment target: 40 patients)
to collect further data proving safety and efficacy of the Capturex® device

Klinikum Arnsberg
Dr. Michael Lichtenberg

U. Hospital Rostock
Dr. Thomas Heller

U. Hospital Galway
Dr. Gerard O’Sullivan

PMCF Aspirex®S (and Capturex ®)

3 centers

120 Patients with acute venous occlusions: veins of the legs, arms and visceral veins

Follow-up up to 36 months

S, Schmidt A, Scheinert D. Rotarex Mechanical Debulking in Acute and Subacute Arterial Lesion: Single-center Experience With 525 Patients. Angiology 2016. doi:10.1177/0003319716646682. Abstract: http://www.ncbi.nlm.nih.gov/pubmed/27194755
Stanek F, Ouhrabkova R, Prochazka D. Mechanical thrombectomy using Rotarex catheter in the treatment of acute and subacute occlusions of peripheral arteries: immediate results, long-term follow-up. Int Angiol. 2013;32(1):52-60. Abstract: http://www.ncbi.nlm.nih.gov/pubmed/23435392
Wissgott C, Kamusella P, Andresen R. Treatment of chronic occlusions of the iliac of femoropopliteal arteries with mechanical rotational catheters. Rofo. 2011;183(10):945-951. doi:10.1055/s-0031-1273451. Abstract: http://www.ncbi.nlm.nih.gov/pubmed/21894596
Lichtenberg M, Stahlhoff W. Friedrich. Endovascular-first strategy for acute and subacute limb ischaemia: Potential benefits of a pure mechanical thrombectomy approach. Vasa 2016, 45(1),7-9 DOI: 10.1024/0301-1526/a000489. Abstract: http://www.ncbi.nlm.nih.gov/pubmed/26986704
Zeller T, Frank U, Bürgelin K, Schwarzwälder U, Horn B, Flügel PC, Neumann FJ. Long-term results after recanalization of acute and subacute thrombotic occlusions of the infra-aortic arteries and bypass-grafts uising a rotational thrombectomy device. RöFo 2002 Dec; 174(12):1559-1665. Abstract: http://www.ncbi.nlm.nih.gov/pubmed/12471529
Wissgott C, Kamusella P, Richter A, Klein-Weigel P, Steinkamp HJ. Mechanical Rotational Thrombectomy for Treatment of Acute and Subacute Occlusions of Femoropopliteal Arteries: Retrospective Analysis of the Results from 1999 to 2005. RöFo 2008 Apr; 180(4): 325-331. Abstract: http://www.ncbi.nlm.nih.gov/pubmed/18499908
Duc SR, Schoch E, Pfyffer M, Jenelten R, Zollikoffer CL. Recanalization of acute and subacute femoropopliteal artery occlusions with the Rotarex catheter: one year follow-up, single center experience. Cardiovasc Intervent Radiol. 2005 Sep-Oct; 28(5): 603-610. Abstract: http://www.ncbi.nlm.nih.gov/pubmed/16132388
Wissgott C, Kamusella P, Andresen R. Treatment of In-Stent Reocclusions of Femoropopliteal Arteries with Mechanical Rotational Catheters. Interventional Radiology 2011,183:1-6. Abstract: https://www.thieme-connect.de/DOI/DOI?10.1055/s-0031-1281634
M. Lichtenberg. Percutaneous Mechanical Thrombectomy by Means of Rotational Thrombectomy. Current Study Situation. Medizinische Klinik 2010, 105(10):705-710 Abstract:http://link.springer.com/article/10.1007%2Fs00063-010-1122-0
R. Silingardi, V. Cataldi, R. Moratto, I. Azzoni, J. Veronesi, G. Coppi. Mechanical thrombectomy in in-stent restenosis: preliminary experience at the iliac and femoropopliteal arteries with the Rotarex system. J Cardiovasc surg 2010; 51:543-50. Abstract: http://www.ncbi.nlm.nih.gov/pubmed/20671638
F.Stanek, R. Ouhrabkova, D. Prochazka. Percutaneous mechanical thrombectomy in the treatment of acute and subacute occlusions of the peripheral arteries and bypasses. Vasa (2016), 45(1),49-56. Abstract: http://www.ncbi.nlm.nih.gov/pubmed/26986710
M.Lichtenberg, W. Stahlhoff, D. Boese, B. Hailer. 12m outcome after percutaneous mechanical thrombectomy for treatment of acute femoropopliteal bypass occlusion. Cardiovasc Interv and Ther 2012 DOI 10.1007/s12928-012-0152-x Abstract: http://www.ncbi.nlm.nih.gov/pubmed/23242521
Lichtenberg M. Kaeunicke M, Hailer B. Percutaneous mechanical thrombectomy for treatment of acute femoropopliteal bypass occlusion. Vas Health Risk Manag. 2012;8:283-9 Abstract: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3363147/
C. Wissgott, P. Kamusella. Recanalization of Acute and Subacute Venous and Synthetic Bypass-Graft Occlusions With a Mechanical Rotational Catheter. Cardiovasc Intervent Radiol (2013) 36_936-942. Abstract: http://www.ncbi.nlm.nih.gov/pubmed/23152037
Fahrni J, Engelberger RP, Kucher N, Willenberg T, Baumgartner. Catheter-based treatment of ilio-femoral deep vein thrombosis – an update on current evidence. Vasa. 2013 May;42(3):161-7. doi: 10.1024/0301-1526/a000264. Abstract: http://www.ncbi.nlm.nih.gov/pubmed/23644367
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Comerota AJ, Grewal N, Martinez JT, Chen JT, DiSalle R, AndrewsL, Sepanski D, and Assi Z. Post-thrombotic morbidity correlates with residual thrombus following CDT for iliofemoral DV. Journal of Vascular Surgery 2012; 55:768-773. Abstract: http://europepmc.org/abstract/med/22277690
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Wissgott C, Steinkamp HJ. Acute occlusion of femoripopliteal bypass: comparison of results of rotational thrombectomy catheters and local lysis. RöFo 2005; 177 DOI:10.1055/S-2005-867768 Abstract: https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-2005-867768
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Vladimir Y. Et al. A retrospective Comparison of Ultrasound-Assisted Catheter Directed Thrombolysis and Catheter-Directed Thrombolysis Alone for Treatment of Proximal DVT. Cardiovasc. Intervent. Radiol (2016) 39:1115-1121. DOI 10.1007/s00270-016-1367-5. Abstract: http://link.springer.com/article/10.1007/s00270-016-1367-5
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Fogarty Catheter. Complications encountered during arterial embolectomy with the Fogarty balloon catheter. https://www.ncbi.nlm.nih.gov/pubmed/961039