SAFETY AND EFFECTIVENESS OF ENDOVASCULAR REVASCULARIZATION FOR PERIPHERAL ARTERIAL OCCLUSIONS

Transcription

1 SAFETY AND EFFECTIVENESS OF ENDOVASCULAR REVASCULARIZATION FOR PERIPHERAL ARTERIAL OCCLUSIONS LIBBY WATCH, MD MIAMI VASCULAR SPECIALISTS MIAMI CARDIAC & VASCULAR INSTITUTE

2 FINANCIAL DISCLOSURES None 2

3 INTRODUCTION Acute lower extremity ischemia accounts for approximately 20% of in-hospital peripheral treatments 1 Accounts for high amputation rates (10-30%) 1 Rapid revascularization is key in minimizing long term damage and also in limb loss prevention Catheter directed thrombolysis is viable in stage I and IIa diseases, however requires extensive time Endovascular thrombectomy may be more feasible Decreased treatment time Potentially fewer procedural complications 3 1 N Engl J of Med. 2012;366(23):

4 PURPOSE Current interventions for peripheral and visceral artery occlusions are associated with incomplete revascularization, serious bleeding complications, long treatment times and morbidity. 2,3 XTRACT was developed as a Power Aspiration Based Extraction Technique using the Penumbra/Indigo System. The PRISM Trial is the first multicenter study for peripheral and visceral artery occlusions designed to obtain: Initial safety and efficacy data on the use of XTRACT in a variety of clinical applications The optimal technique and implementation of this system, including its utility with and without adjunctive lytic therapy 2 J Vasc Surg. 2006;44(3): N Engl J Med. 1998;338(16):

5 THE PENUMBRA/INDIGO SYSTEM Highly trackable and effective aspiration system with a proven track record of success in ischemic stroke therapy, is designed for thrombi and emboli recovery in small to medium size vessels The flexible and effective aspiration system may help reduce overall procedural time and improve outcome while also minimizing complications XTRACT involves the use of Indigo System to achieved continuous vacuum through reperfusion catheters used for thrombus extraction 5

6 METHODS PRISM enrolled a total of 79 patients in this retrospective case study Aspiration thrombectomy using the Penumbra/Indigo System was performed in the following cases: Failed thrombolysis Acute limb ischemia Distal emboli secondary to preceding intervention TIMI score classification was assessed at presentation, prior to and immediately following aspiration thrombectomy, and post all interventions (if necessary) 6

7 PATIENT SELECTION Inclusion Criteria Evidence of peripheral or visceral arterial occlusion (TIMI 0-1) wherein XTRACT was the treatment modality Exclusion Criteria Participation in other trials that may confound the present study results 7

8 ENDPOINTS Efficacy Recanalization to TIMI 2-3 Safety Procedural and/or device-related serious adverse events within 24 hours of XTRACT 8

9 BASELINE CHARACTERISTICS Patient Demographics Number of patients, N 79 Age (years), mean ±SD 68.5 ± 12.5 Female, % (n/n) 41.8% Patient Medical History % Peripheral Vascular Disease 86.1% Hypertension 82.9% Diabetes 33.3% Atrial Fibrillation 15.6% Smoking 74.3% Stroke 16.0% Coronary Artery Disease 37.3% Dyslipidemia 69.7% 9

10 OCCLUSION SITES Target vessel location Popliteal 35.4% Peroneal 7.6% Posterior tibial 5.1% Anterior tibial 6.3% Tibial-peroneal trunk 3.8% Superficial femoral 29.1% Profunda femoris 6.3% Common Femoral 1.3% Brachial 1.3% External iliac 1.3% Common iliac 1.3% Sciatic 1.3% 10

11 PROCEDURAL CHARACTERISTICS Treatment Modality % Study device used as initial therapy 49.4% Study device after thrombolytics 15.2% Study device after other mechanical therapy 19.0% Study device after both thrombolytics and mechanical 16.5% 11

12 PRE AND POST THROMBECTOMY OUTCOME % 90 RATE OF REVASCULARIZATION, % Baseline Prior to INDIGO aspiration thrombectomy 87.2% Immediately post INDIGO thrombectomy Post all interventions 77.2 TIMI 0 TIMI 1 TIMI 2 TIMI 3 PROCEDURE TIMELINE 12

13 REVASCULARIZATION BY TREATMENT MODE Indigo/PS as secondary or salvage therapy, 50.6% (40/79) Treatment Mode Penumbra/Indigo as initial therapy tpa prior to Penumbra/Indigo Mechanical Thrombectomy prior to Penumbra/Indigo Both adjunctive tpa + mechanical therapies prior to Penumbra/Indigo N TIMI 2-3 Post Penumbra/Indigo TIMI 2-3 Post All Interventions % 94.9% % No Change %* 100% % No Change Total = % (74/78) 96.2% (76/79) TIMI 3 was achieved in 77.2% (61/79) post all interventions Median procedure time from puncture to aspiration off: 67.5 mins [IQR 50 81] 13 *TIMI score was unable to be assessed for 1 patient

14 SAFETY OUTCOME Serious Adverse Events % of Patients Procedure related SAE within 24h 8.9% Device related SAE 0 13 SAEs occurred within 24h of intervention in 7 patients 14

15 CASE PRESENTATION History: 51 year old female with a history of mild left calf claudication Patient presents with approximately one week history of acute foot pain Exam: Labs Cool foot, no DP or PT signals Sensory deficit involving most of the foot Motor function intact Creat: 2.4

16

17

18

19

20

21

22

23

24

25

26

27 3 mm PTA Angiogram via balloon catheter

28 POST 3M SFA PTA

29 AT AND DP CONFIRMED TO BE PATENT

30 WHAT TO DO NOW? Lysis? Mechanical Thrombectomy? Surgery? What to do about SFA lesion?

31

32

33

34 Post 3mm PTA Post 4mm PTA Post 4mm DCB

35

36 DISCUSSION The XTRACT technique is atraumatic, versatile, safe and effective against peripheral and vascular arterial occlusions Effective as frontline or after failed thrombolysis/thrombectomy 87.2% reperfusion (TIMI 2-3) as initial therapy 96.2% post all intervention No device related SAEs Other applications Emboli from prior interventions Acute ischemia Failed thrombolysis As frontline therapy 36

37 BENEFITS OF INDIGO/PENUMBRA THROMBECTOMY Offers faster time to revascularization compared to surgical embolectomy Reduced risk of morbidity Minimize risks of thrombolytic therapy, although may be used as warranted Open surgery excludes the potential for adjunctive lytic therapy Promising results in utility as frontline device Potential to reduce or eliminate lytic therapy reduce cost and complications 37

38 LIMITATIONS OF THE TRIAL No concurrent control group No patient follow-up was performed, thus unable to assess long-term outcome: Amputation-free survival QOL impacts Survival at 30 days and 1 year Notably, conducting a larger trial may be a challenge given the great variability of the patients and the use of adjunctive therapies both prior to and after aspiration thrombectomy With larger catheters, blood loss may become a concern that needs to be assessed, more experience needed from future studies 38

39 CONCLUSION Final trial results proved promising, demonstrating the Penumbra/Indigo System and XTRACT as effective in treatment of peripheral/visceral occlusions. 39