WIRION EPS filter with jetstream atherectomy of femoropopliteal arterial disease: A single center experience

CARREV-01436; No of Pages 4 Cardiovascular Revascularization Medicine xxx (xxxx) xxx

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Cardiovascular Revascularization Medicine

WIRION EPS filter with jetstream atherectomy of femoropopliteal arterial disease: A single center experience☆ Elizabeth M. Sharis, Nicolas W. Shammas ⁎, Gail A. Shammas, Susan Jones-Miller Midwest Cardiovascular Research Foundation, Davenport, IA, United States of America

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Article history: Received 17 October 2018 Accepted 13 November 2018 Available online xxxx Keywords: Embolic filter Atherectomy Superficial femoral artery Popliteal artery Distal embolization Macrodebris

a b s t r a c t Background: The WIRION EPS filter was recently approved by the Food and Drug Administration (FDA) to be used in conjunction with all atherectomy devices when treating infrainguinal peripheral arterial disease. The safety of this filter with Jetstream atherectomy (JA) in a real world setting remains unclear. Methods: Consecutive patients from the practice of one operator who underwent JA under WIRION EPS when treating femoropopliteal arteries were enrolled in this retrospective analysis. The primary safety endpoint was the ability of the filter to capture macrodebris with no dissection or thrombosis at the filter site and no filterrelated major adverse events. Descriptive analysis on demographics, clinical, procedural and angiographic variables was done using mean ± SD for continuous variables and percentages for categorical variables. Results: 37 patients were enrolled in this study between June 2016 and September of 2018 (64.9% males, age 68.7 ± 9.0, BMI 27.7 ± 5.4). TASC II classification of the treated lesions were 51.4% B, 24.3% A, 21.6% C, and 2.7% D. At the filter site, spasm occurred in 1/37 (2.7%), while dissection did not occur (0%). Embolization within the filter was found in 51.4% of patients: 14/37 (37.8%) macro debris and 5/35 (13.5%) micro debris. Clinically significant embolization distal to the filter that required treatment with more than a simple aspiration was 1/37 (2.7%). Conclusion: WIRION EPS filter use with Jetstream atherectomy was safe and was associated with a low rate of significant distal embolization that required more than a simple aspiration to treat. © 2018 Elsevier Inc. All rights reserved.

1. Introduction Distal embolization (DE) remains a concern in peripheral vascular interventions; clinically relevant DE has been found in 1.6–5% of such procedures, but occult embolization may occur in up to 98% of cases [1–3]. Clinically significant DE consisting of macro debris has been defined as having an axial length ≥ 2 mm, while dust-like debris are considered microdebris [4]. Microdebris, however may also be associated with adverse events in patients with compromised outflow [5]. Since 2014, atherectomy has become more widely accepted as the initial step in treating femoropopliteal arterial disease [6]. The Jetstream device (Boston Scientific, Maple Grove, MN) is a rotational and aspiration device designed to suction debris as they are generated during atherectomy. Despite this safety feature it has been found to have DE rates ranging that can be as high as 22% [7–8]. Recently the WIRION EPS filter (Gardia Medical) was approved by the Food and Drug administration based on the pivotal WISE LE study ☆ Conflict of interest: Dr NWShammas receives research and educational grants from Boston Scientific, Bard, Intact Vascular, VentureMed group. ⁎ Corresponding author at: Midwest Cardiovascular Research Foundation, 1622 E Lombard Street, Davenport, IA 52803, United States of America. E-mail address: [email protected] (N.W. Shammas).

[9] to be used with all atherectomy devices. The WIRION filter (Fig. 1) can be used on any 0.014″ guidewire and can be locked and positioned at any level within the artery. The safety of the WIRION with JA in a real world setting has not been evaluated. In this study, we present our experience with the safety and capture rate of debris using the WIRION filter in conjunction with JA. 2. Methods This study included 37 consecutive patients at the same hospital undergoing peripheral vascular interventions with both WIRION EPS and JA by a single operator (NWS). The study was approved by the Institutional Review Board and waiver of consent was obtained due to the retrospective nature of the study. All HIPPA rules were adhered to. The WIRION EPS is a monorail system that can be locked on any 0.014-in. guidewire and at any location within the vessel. The basket is covered by a Nylon-12 membrane with 120 μm pores. The filter can be collapsed and retrieved in a retrievable catheter. The filter is one size that fits in vessels with a diameter of 3.5 to 6 mm. All patients received heparin during the procedure. Access was from the contralateral common femoral artery. 7-French Destination sheath (Terumo Medical, Somerset, NJ) were utilized. After the lesion was crossed, the filter was mounted on the wire at the desired location at

https://doi.org/10.1016/j.carrev.2018.11.014 1553-8389/© 2018 Elsevier Inc. All rights reserved.

Please cite this article as: E.M. Sharis, N.W. Shammas, G.A. Shammas, et al., WIRION EPS filter with jetstream atherectomy of femoropopliteal arterial disease: A single center ex..., Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2018.11.014

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had a history of tobacco use. Rutherford classifications pre-procedure were 64.9% claudicates [1–3], 10.8% ischemic [4–6], 5.4% asymptomatic or unable to be assessed, and 18.9% unavailable. Onset of symptoms were 97.3% chronic and 2.7% subacute. Table 2 shows procedural and angiographic variables. Total occlusions were treated in 24.3% of the patients and TASC type classifications of the treated lesions were 51.4% B, 24.3% A, 21.6% C, and 2.7% D. Lesions were 150.4 mm ± 99.2 in length with diameters of 5.8 mm ± 0.7. Location of the distally placed WIRION filter was 81.1% in the popliteal, and a Spartacore wire (Abbott Laboratories, Abbott Park, Illinois) was used to load the filter for 97.3% of patients. In one patient the Thruway wire (Boston Scientific, Maple grove, MN) was used. Pre-intervention stenosis was 88.4% ± 10.3 and post-intervention it was 9.9% ± 10.6. Table 3 shows outcome variables. One adverse device effect occurred (2.7%) in which the Spartacore wire became stuck on the Jetstream device, but resulted in no complications. Notably, debris that was observed in the filter after removal occurred in 51.4% of the patients, with 14/37 (37.8%) being macro debris and 5/35 (13.5%) micro debris. Clinically significant embolization distal to the filter that required treatment with more than a simple aspiration was 1/37 (2.7%), while total distal embolization after the filter was removed irrespective how it was treated was 3/37 (8.1%). Of the 3 patients that embolized after filter removal, 2 also had macro debris captured in the filter. Spasm occurred in 1/37 (2.7%), while dissection at the filter site did not occur (0%). In 30 day follow up visits (Table 4), patient Rutherford Becker classifications were 43.2% asymptomatic, 18.9% moderate claudication, 5.4% severe claudication, and 2.7% ischemic, reflecting improvement compared to pre-procedure. One adverse event was reported, an unplanned left toe amputation that occurred before the return office visit for the procedure involved in the study. Neither TVRs nor TLRs occurred.

4. Discussion

Fig. 1. WIRION filter (Gardia Medical).

least several centimeters distal to the lesion. Jetstream atherectomy was performed using the Jetstream XC device (Boston Scientific, Maple grove, MN). A typical treatment consisted of 2 blades up and 2 blades down run although this may have varied with some lesions. Following the JS atherectomy, adjunctive treatment was carried on with balloon angioplasty and stenting if needed. The filter was then removed and inspected for debris as part of the operator's routine. Also digital subtraction angiography was performed on the outflow vessels to evaluate for DE. Demographic, clinical, procedural, angiographic, acute outcomes, and thirty-day follow up data were obtained from medical records. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) was utilized to categorize treated lesions [10]. Distal embolization variables were kept consistent with the definitions utilized in the WISE LE study [9]. Descriptive analysis was performed on all variables with mean ± SD for continuous variables and percentages for categorical variables. 3. Results Demographics and clinical variables are shown in Table 1. Of the 37 consecutive patients, 64.9% were males, age 68.7 ± 9.0 years, and body mass index 27.7 ± 5.4 kg/m2. Diabetes was present in 51.4% and 81.1%

The WIRION filter with JA appeared safe with no filter-related complications. In one case the Jetstream could not be advanced or retrieved from over the wire and the filter and wire had to be removed as one unit. This did not lead to complications and was not a filter-related incident. Notably there was only one occurrence of spasm (2.7%) and no dissections.

Table 1 Demographics and clinical variables.

Age (years)

n

Mean ± SD

37

68.7 ± 9.0

Females Males Peripheral vascular disease Diabetes mellitus Hypertension Cardiovascular disease Hyperlipidemia Tobacco use Coronary artery disease Heart failure Rutherford Becker classification Class III Class IV Class V Onset of symptoms Subacute Chronic Reason for initial procedure Pain Pain and abnormal ABI Non-healing ulcer

n 37 37 37 37 37 37 37 37 37 37

n′ 13 24 27 19 33 2 37 30 24 0

% 35.1 64.9 73 51.4 89.2 5.4 100 81.1 64.9 0

29 29 29

25 3 1

86.2 10.3 3.4

37 37

1 36

2.7 97.3

37 37 37

6 30 1

16.2 81.1 2.7

Please cite this article as: E.M. Sharis, N.W. Shammas, G.A. Shammas, et al., WIRION EPS filter with jetstream atherectomy of femoropopliteal arterial disease: A single center ex..., Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2018.11.014

E.M. Sharis et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx Table 2 Procedural and angiographic variables.

Table 3 Outcome variables. n

Index vessel Right femoropopliteal Left femoropopliteal Number of runoff vessels None 1 runoff vessel 2 runoff vessels 3 runoff vessels Total occlusion Calcium Not severe Severea Type of lesion Denovo In-stent restenosis Restenosis - no stent Mixed lesions TASC type classification A B C D Thrombus Location of filter Superior femoral artery Popliteal Jetstream size 2.1/3.2 2.4/3.4 Wire used to load WIRION filter Spartacore Thruway Adjunctive balloon used Balloon angioplasty Drug coated balloon Adjunctive stent used None Non-drug-eluding Drug-eluding Embolectomy device Aspiration catheter

ABI pre-rest right ABI pre-rest left Pre-stenosis (%) Post-final stenosis (%) Lesion length (mm) Lesion diameter (mm) Activated clotting time (seconds) Total run time (minutes) Volume of aspirate Fluoroscopy time (minutes) Total procedure time (minutes) a

3

n′

%

37 37

22 15

59.5 40.5

37 37 37 37 37

2 4 14 17 9

5.4 10.8 37.8 45.9 24.3

16 16

8 8

50 50

37 37 37 37

15 8 6 8

40.5 21.6 16.2 21.6

37 37 37 37 37

9 19 8 1 1

24.3 51.4 21.6 2.7 2.7

36 36

6 30

16.7 83.3

37 37

3 34

8.1 91.9

37 37

36 1

97.3 2.7

37 37

11 26

29.7 70.3

37 37 37 37 37

28 5 4 0 3

75.7 13.5 10.8 0 8.1

n

Mean ± SD

34 32 37 37 37 37 37 3 1 36 37

0.8 ± 0.2 0.8 ± 0.3 88.4 ± 10.3 9.9 ± 10.6 150.4 ± 99.2 5.8 ± 0.7 244.2 ± 37.6 2.5 ± 0.7 101.1 217.4 ± 60.9 77.4 ± 26.0

Severe calcium defined as bilateral calcium by operator, ABI = ankle brachial index.

DE in this analysis support previous studies involving different atherectomy devices used concomitantly with an embolic filter. Krishnan et al. found 62.4% of patients had debris when atherectomy was performed with a NAV-6 (Abbott Laboratories, Abbott Park, Illinois), or SpiderFX filter (Medtronic, St Paul, MN). Debris occurred predominantly in total occlusions and long lesions [10]. Presence of total occlusions was also determined to be high predictor of DE by Mendes et al. [11]. Furthermore, Shammas et al. has shown that in-stent restenosis is also an independent predictor of DE [12]. In our study, all 3 patients with DE had total occlusions and 2 of them had in-stent restenosis. The large amount of macrodebris captured by the WIRION EPS filter also highlights the silent nature of DE in the majority of patients when no filter is typically used. The long term significance of this occult DE is

Embolization within the filter None Macro Dust size After filter removed at end of procedure: significant distal embolizationa After filter removed at end of procedure: total distal embolizationb Spasm at filter site Dissection at filter site Amputation Vascular death due to index artery All cause death In-hospital major bleedingc Access site complications Acute vessel closure in-hospital or after Other adverse events None Type A dissection Type C dissection Type D dissection Undefined dissections a b c

n

n′

%

37 37 37 37 37 37 37 37 37 37 37 37 37

18 14 5 1 3 1 0 0 0 0 0 0 0

48.6 37.8 13.5 2.7 8.1 2.7 0 0 0 0 0 0 0

37 37 37 37 37

28 2 2 1 4

75.7 5.4 5.4 2.7 10.8

That required treatment of more than aspiration. Total Distal embolization beyond the filter irrespective of treatment modality. N3 units of blood given with a source of bleed.

unclear. It is also possible that the filter does not only reduce the rate of DE but also the severity of the DE when it occurs as it has intercepted and captured the majority of macrodebris. The major limitation of this study is its retrospective nature. Also it is unclear whether these results can be reproduced by other operators, although the WISE LE study indicated consistency of good results among several centers that have used this device [9]. In addition, pathology on debris was not performed in this study. In the WISE LE study, pathology captured by the WIRION filter consisted mostly of “fibrous tissue fragments, red cells, leukocytes, and fibrin-platelet aggregates.” In this study, we noted a good symptomatic improvement in the short term outcomes of patients (Rutherford and ankle brachial index) but the impact of embolic filters on long term hard outcomes remain unclear. We conclude that the WIRION filter is safe with JA and no filterrelated adverse events have occurred. The filter appears to be effective in capturing debris in a large proportion of patients. The clinical significance of capturing these debris remains unclear.

Table 4 30 day follow up outcomes.

ABI pre-rest right ABI pre-rest left

Rutherford Becker classification Class 0 Class 2 Class 3 Class 5 Target vessel revascularization Target lesion revascularization Acute closure Minor amputationa Vascular death due to index Other adverse events a

n

Mean ± SD

34 32

0.8 ± 0.2 0.8 ± 0.3 n

n′

%

26 26 26 26 36 36 36 36 36 36

16 7 2 1 0 0 0 1 0 0

61.5 26.9 7.7 3.8 0 0 0 2.8 0 0

Unplanned toe amputation in a patient with preexisting gangrenous toe.

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Please cite this article as: E.M. Sharis, N.W. Shammas, G.A. Shammas, et al., WIRION EPS filter with jetstream atherectomy of femoropopliteal arterial disease: A single center ex..., Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2018.11.014