- Email: [email protected]
Jetstream Atherectomy System for Treatment of Femoropopliteal Artery Disease: A Single Center Experience and Mid-term Outcomes
Clinical Research Jetstream Atherectomy System for Treatment of Femoropopliteal Artery Disease: A Single Center Experience and Mid-term Outcomes Vincenzo Ardita,1 Sonia Ronchey,2 Matteo Orrico,2 Vincenzo Pappalardo,3 Alberto Davı`,2 Stefano Fazzini,2 Vittorio Alberti,2 and Nicola Mangialardi,2 Milan, Rome, and Varese, Italy
Background: The aim of this study is to assess our experience and mid-term outcomes using Jetstream atherectomy system for treatment of femoropopliteal artery disease (FPAD). Methods: Data of 30 patients with FPAD treated at our center between 2013 and 2016 were analyzed. Two subgroups of patients were identified: Group A included patients (n ¼ 18) with de novo lesions; Group B (n ¼ 12) included those with in-stent restenosis. The primary study end points assessed were technical success, perioperative mortality, and major adverse event (MAE) rate at 30 days (distal embolization, major amputation, and target lesion revascularization). Other outcomes measured were survival, primary, and secondary patency, and freedom from amputation at 1 and 3 years of follow-up, respectively. Results: Technical success was 100% for both groups. The MAE rate was 8.7%. No distal filter was adopted during intervention. Angioplasty was associated with 93.3% of cases (93.3% vs. 100%; P ¼ 0.15), drug-eluting balloon (DEB) in 12 cases (22.2% vs. 66.6%; P ¼ 0.008), drug-eluting stent and bare metal implantation in 1 (5.6% vs. 0%; P ¼ 1) and 4 cases (11.1% vs. 16.7%; P ¼ 1), respectively. The cumulative primary and secondary patency rates were 75.1% and 95.5% at 1 year, and 70.4% and 84.8% at 3 years of follow-up, respectively. The survival and freedom from amputation were 96.4% and 85.8% at 1 and 3 years of follow-up, respectively. The freedom from target lesion revascularization was 91.7% and 83.4% at 1 and 3 years from intervention. Conclusions: The use of the Jetstream appears to be safe and feasible with no distal embolization and low rate perioperative complications. Moreover, encouraging outcomes were observed when atherectomy was associated to DEB angioplasty.
INTRODUCTION Peripheral artery disease (PAD) has become a worldwide problem. Its prevalence increases with the age and the presence of comorbidities such as
Author contribution: Vincenzo Ardita wrote the paper; Sonia Ronchey, Matteo Orrico, and Alberto Davı` collected the data; Vincenzo Pappalardo performed the statistical analysis; Stefano Fazzini and Vittorio Alberti analyzed the data; and Nicola Mangialardi gave the final approval to the article. Funding: None. Conflict of interest: The authors have no conflicts of interest. 1
Vascular Surgery Unit, Cardiovascular Thoracic Department, Hospital S. Raffaele, Vita-Salute University, Milan, Italy. 2 Unit of Vascular Surgery, Cardiovascular Thoracic Department, Hospital S. Filippo Neri, Rome, Italy.
hypertension, smoke, diabetes mellitus, and dyslipidemia. The management of PAD can be difficult when diffuse atherosclerotic burden, chronic total occlusion, presence of critical limb ischemia, and lack of adequate distal runoff are present.1 3 Department of Surgery, Circolo Hospital and Macchi Foundation, Varese, Italy.
Correspondence to: Vincenzo Ardita, MD, Vascular Surgery Unit, Cardiovascular Thoracic Department, San Raffaele Hospital, VitaSalute University, Via Olgettina, 60, 21300 Milan, Italy; E-mail: [email protected] Ann Vasc Surg 2019; -: 1–10 https://doi.org/10.1016/j.avsg.2019.04.052 Ó 2019 Elsevier Inc. All rights reserved. Manuscript received: March 1, 2019; manuscript accepted: April 6, 2019; published online: - - -
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Open repair still remains the gold standard for the treatment of PAD, but endovascular therapy has been shown to be a valid alternative overall for high risk patients or unfit to standard surgical approach.2,3 Furthermore, improvements in device technology have facilitated the treatment of complex lesions; in fact, drug eluting stent (DES) and balloon (DEB) have been shown to be superior to balloon angioplasty reducing target lesion revascularization (TLR).4e6 Lesion length, high grade of calcification, and total occlusion have been shown to predict the need for bail-out stenting. However, stenting of femoropopliteal vessels continues to carry high rate of restenosis and occlusion resulting in disappointing long-term results.7,8 An alternative approach is the excision of the obstructing arterial plaque using atherectomy devices. In randomized trials, atherectomy has been shown to reduce dissection rate and bail-out stenting,9 minimizing the stent use in longer femoral popliteal lesions. The Jetstream device (Pathway Medical Technologies, Inc., Redmond, WA) is a rotational aspiration atherectomy system that combines rotablation with aspiration capability10 offering the possibility to debulk the plaque burden within the vessel and decreasing the limitations and complications of traditional angioplasty such as elastic recoil and dissection.11 However, while in literature few articles show the real safety and efficacy of this device in the early and mid-term period, long-term outcomes are still lacking. Therefore, we describe our experience using Jetstream atherectomy system in the treatment of the femoropopliteal artery lesions, assessing the feasibility and safety of this device and showing the outcomes at 3 years of follow-up.
primary care physician office notes and duplex ultrasound (DUS). This study followed the principles outlined in the Declaration of Helsinki and used only information obtained from the review of medical records. Patients gave consent for the anonymous collection of their data on the standard consent form provided by our institution. Ethical committee approval was waived according to Italian laws.
MATERIALS AND METHODS
Follow-up
Study Population
All patients underwent preoperative physical and clinical examination, Rutherford classification, DUS, and ABI evaluation. Preoperative computed tomography angiography was performed when the stenosis or occlusions were not adequately evaluated by DUS. Postoperative imaging follow-up protocol consisted in DUS examination before discharge at 1 and 12 months, and yearly thereafter. Follow-up also included clinical examination, ABI, and RC assessment.
This is a retrospective, single center, nonrandomized study, including 30 patients, with Rutherford Categories (RCs) between 2 and 5, and mean anklee brachial index (ABI) of 0.41 ± 0.10 (range 0.3e 0.55), who underwent percutaneous treatment with Jetstream atherectomy at our institution between 2013 and 2016. Patient’s data were retrospectively reviewed from a prospectively maintained clinical database. Patient’s demographics and comorbidities are listed in Table I. Two subgroups of patients were identified: Group A included patients (n ¼ 18) with de novo lesions and Group B (n ¼ 12) included those with in-stent restenosis (ISR). Patient’s clinical information was obtained from clinic visit data, telephone calls, or referring
End Point Analyzed outcomes included technical success defined as residual stenosis of less than 30% after procedure. Other procedures, including adjunctive angioplasty or stenting, were recorded. Stenting was performed only in case of residual dissection after atherectomy and angioplasty. Specific considered clinical end points included perioperative mortality and freedom from major adverse events (MAEs) at 30 days following the treatment. MAEs were defined as any unwanted side effect of study or treatment that results in distal embolization, myocardial infarction (MI), and major amputation. Other end points assessed were primary patency defined as freedom from restenosis of 50% calculated with DUS without reintervention; secondary patency as freedom from restenosis of 50% at the time of follow-up visit after reintervention in case of restenosis or occlusion; TLR and freedom from amputation. We also analyzed survival rate, and the clinical and hemodynamic success. The first was defined by the clinical category improvement >1 on Rutherford scale at follow-up period; the second was defined by an ABI value that has improved by >0.15 at follow-up period.
Statistical Analysis The collected data were expressed as means ± standard deviation or median + interquartile ranges (25%e 75%), and percentages. Comparisons were made using a 2-tailed t-test and Pearson’s chi-squared test as appropriate. Values of P < 0.05 were considered as
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Table I. Baseline characteristics and differences between patients with de novo lesions (Group A) and those with in-stent restenosis (Group B) Patient characteristics
Overall population
Group A (de novo lesion)
Group B (in-stent lesion)
P value
N patient Age, mean (SD) Male patients BMI, mean (SD) COPD HTA CAD Stroke/TIA DM Dyslipidemia CRF Serum creatinine levels (mg/dL) Smoking AAA Previous aortoiliac surgery Antiplatelet therapy Single Double No therapy Anticoagulant ASA I II III IV ABI RC II III IV V VI Lesion localization SFA Popliteal artery SFA + popliteal artery Lesion length (cm)
30 71.5 ± 10.1 20 (66.7%) 25.1 ± 2.5 5 (16.7%) 27 (90%) 11 (36.7%) 1 (3.3%) 14 (46.7%) 27 (90%) 8 (26.7%) 1.45 ± 1.71
18 71.1 ± 9.7 13 (62.2%) 25.2 ± 2.7 4 (22.2%) 17 (94.4%) 7 (38.9%) 0 7 (38.9%) 15 (88.3%) 6 (33.3%) 1.88 ± 2.22
12 72.1 ± 9.9 7 (58.3%) 25.6 ± 2.7 1 (8.3%) 10 (83.3%) 4 (33.3%) 1 (8.3%) 6 (50%) 12 (100%) 2 (16.7%) 0.91 ± 0.25
e 0.387a 0.461b 0.988a 0.625b 0.592b 0.706b 0.400b 0.452b 0.255b 0.241b
12 (40%) 1 (3.3%) 0
7 (38.9%) 1 (5.6%) 0
5 (41.7%) 0 0
0.893b 0.572b e
20 4 5 1
(66.7%) (13.3%) (16.7%) (3.3%)
9 (50%) 4 (22.2%) 5 (27.8%) 0
11 (91.7%) 0 0 1 (8.3%)
0.023b 0.129b 0.065b 0.419b
6 (20%) 20 (66.7%) 4 (13.3%) e 0.41 ± 0.10
4 (22.2%) 12 (66.7%) 2 (11.1%) e 0.41 ± 0.09
2 (16.7%) 8 (66.6%) 2 (16.7%) e 0.41 ± 0.10
1b 1b 1b
3 (10%) 10 (33.3%) 6 (20%) 8 (26.7%) 3 (10%) n ¼ 52 30 (57.7%) 7 (13.5%) 15 (28.8%) 11.7 ± 5.1
2 (11.1%) 6 (33.3%) 4 (22.2%) 5 (27.8%) 1 (5.6%) n ¼ 29 18 (62.1%) 4 (13.8%) 7 (24.1) 9.9 ± 4.01
1 (8.3%) 4 (33.3%) 2 (16.7%) 3 (25%) 2 (16.7%) n ¼ 23 13 (56.5%) 2 (8.7%) 8 (34.8%) 14.6 ± 5.6
1b 1b 1b 1b 0.547b
0.575a
0.425b 0.631b 0.721b 0.989a
Bold values indicate statistical significance. AAA, abdominal aortic aneurysm; ABI, ankleebrachial index; ASA, American Society of Anesthesiologists; BMI, body mass index; CAD, coronary artery disease; CFR, chronic renal failure (glomerular filtration rate <40 mL/min); COPD, chronic obstructive pulmonary disease; DM, diabetes mellitus; HTA, hypertension; RC, Rutherford classification; SD, standard deviation; SFA, superficial femoral artery; TIA, transient ischemic attack. a Student’s t-test. b Chi-squared test.
significant. Primary and secondary patency rates, and freedom from reintervention and from amputation rates were reported using the KaplaneMeier method. Curves were displayed up to a value of standard error <0.10, with the 95% confidence interval also displayed. All analyses were performed using R version 3.3.0 (open source software; R Foundation for Statistical Computing, Vienna, Austria).
Technique All procedures were performed in a C-arm (Alien EAlien 3030 cardio; Eurocolumbus, Salt Lake City, UT) equipped operating room under local anesthesia (2% lidocaine) in supine position. The common femoral artery access site was studied preoperatively with DUS to exclude the presence
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Fig. 1. (A) Angiography demonstrating occluded superficial femoral artery; (B) crossing of the lesion using a 0.01400 guidewire (Asahi Intecc, Seto, Japan, made in Vietnam); (C) debulking of the lesion using Jetstream
Atherectomy System XC (Pathway Medical Technologies, Inc., Redmond, WA); (D) arteriogram demonstrating a good vessel patency achieved after atherectomy.
of stenosis and circumferential calcifications at the site of puncture. An omolateral access was chosen in 4 of 23 cases and contralateral one in the other cases. The omolateral access was gained through a short 7F percutaneous introducer sheath (Radifocus Introducer II; Terumo Corporation, Tokyo, Japan) and the contralateral access with a long 7F percutaneous introducer sheath (Flexor; Cook, Bloomington, IN). A preliminary angiography was employed to confirm the diagnosis (Fig. 1A) and subsequently a systemic heparinization was achieved with a 5,000 UI heparin bolus. Lesions were crossed with a luminal technique using a 0.01400 guidewire (Asahi Intecc, Seto, Japan, made in Vietnam) (Fig.1B). The wire was supported and directed by a 4F Bern catheter (Boston Scientific). Once the lesion was crossed the debulking of the plaque was performed with Jetstream Atherectomy System XC (Fig. 1C). An angiography was performed before device activation to document the target vessel region and the position of the device during the treatment. The device was advanced slowly (1 mm/sec) and continuously in order to avoid vessel damage. As recommended, we stopped the activation of the device every 40 sec for 20 sec. During the treatment, periodically we assess aspiration flow by observing flow through the tubing and into the collection bag. When the treatment was completed an
angiography was performed to evaluate the entire target vessel and runoff (Fig. 1D).
RESULTS A total of 52 lesions in 30 patients were treated at our institution between 2013 and 2016. No preoperative statistical differences have been recorded between the 2 groups of patients analyzed, except for antiplatelet therapy at the time of in-hospital admission. The majority of lesions were localized at the level of the superficial femoral artery (62.1% vs. 56.5%; P ¼ 0.42). The mean lesion length was 11.7 ± 5.1 cm (9.9 ± 4.01 vs. 14.6 ± 5.6; P ¼ 0.98). Twenty-nine lesions were treated in Group A (de novo lesion) and 23 in Group B (in-stent lesion). The technical success was achieved in all cases. Intraoperative details are listed in Table II. Balloon angioplasty was associated with 93.3% of patients with no differences between the 2 groups. DEB angioplasty was associated with 40% of cases, overall for patients of the second group (22.2% vs. 66.6%; P ¼ 0.008). Stent implantation was performed in 5 cases (1 DES and 4 bare metal stent) due to residual stenosis and dissection. In 6 cases (20%) the procedures were associated with the treatment of below the knee vessels (16.7% vs.
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Table II. Intraoperative characteristics Patient characteristics
Technical success Anterograde access Total duration of procedure (min) Total fluoroscopy time Total contrast administration (mL) Angioplasty DEB Number of stent used DES BMS Access complication Distal embolization Amputation BK Amputation AK Wound curettage
Overall population
Group A (de novo lesion)
Group B (in-stent lesion)
P value
100% 19 100.2 ± 34.2
100% 15 (83.3%) 104.7 ± 37.04
100% 8 (66.6%) 92.9 ± 30.3
e 0.391a 0.919b
39.9 ± 17.6 61.6 ± 26.1
38.6 ± 17.4 61.4 ± 25.9
38.1 ± 19.5 58.3 ± 26.2
0.077b 0.314b
28 (93.3%) 12 (40%)
18 (100%) 4 (22.2%)
10 (83.3%) 8 (66.6%)
0.151a 0.008a
1 (3.3%) 4 (13.3%) 0% 0% 0% 1 (3.3%) 5 (16.7%)
1 (5.6%) 2 (11.1%) 0% 0% 0% 0% 3 (16.7%)
0% 2 (16.7%) 0% 0% 0% 1 (8.3%) 2 (16.6%)
1a 1a e e e 0.400a 1a
Bold values indicate statistical significance. AK, above the knee; BK, below the knee; BMS, bare metal stent; DEB, drug-eluting balloon; DES, drug-eluting stent. a Chi-squared test. b Student’s t-test.
24.9%; P ¼ 0.14). Embolic protection system was never used. In 5 patients wound curettage was associated (16.7% vs. 16.6%; P ¼ 1). One patient of the second group underwent limb fasciotomy due to the onset of revascularization syndrome. All patients who were under single antiplatelet therapy before the treatment were discharged under double antiplatelet therapy at least for 3 months. Thirty-day Outcomes Twenty-nine patients completed 1 month of followup. The MAE rate was 8.7%: 1 patient had MI and another one underwent major amputation due to revascularization syndrome and worsening of symptoms. Both patients belonged to the second group. After the procedure, during the hospitalization time, 1 patient of the first group underwent Lisfranc amputation. No embolic events, perforation, infection, dissection, renal failure, and thrombus formation were observed. Outcomes are listed in Table III.
month, 83.3% at 1 year, and 72.2% at 3 years of follow-up, without any statistical differences between the 2 groups. Moreover, an improvement in ABI was recorder (P ¼ 0.019 and 0.15 at 1 and 3 years). The cumulative primary and secondary patency rates were 75.1% and 95.5% at 1 year, and 70.4% and 84.8% at 3 years of follow-up, respectively (Figs. 2 and 3). The differences between the 2 groups of patients analyzed are listed in Table III. The survival and freedom from amputation were 96.4% and 85.8% at 1 and 3 years of follow-up, respectively (Figs. 4 and 5). The freedom from TLR was 91.7% and 83.4% at 1 and 3 years from intervention. No differences were documented between the 2 groups of patients analyzed. Nevertheless, what we observed from the study was that patients who received atherectomy and DEB (n ¼ 12) angioplasty together showed a lower rate of restenosis compared to those where atherectomy was associated with simple angioplasty (n ¼ 12) at 1 year of follow-up (83.3% vs. 50%; P < 0.05).
Mid-term Outcomes
DISCUSSION
At mean follow-up time of 29.2 ± 17.05 months, 24 patients completed 1 year of follow-up and 18 patients completed 3 years. During this period, 1 death (unrelated to device or procedure) and 3 major amputations occurred. Mean RC improved at least 1 class from the baseline in 96.5% of patients at 1
Significant advances have been made in the vascular treatment of PAD with new technologies developed to improve the revascularization of complex vascular lesions. The Jetstream atherectomy system has the distinct advantage of removing the obstructing atherosclerotic or intimal hyperplastic
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Table III. Postoperative outcomes Patient characteristics
Overall population
Group A (de novo lesion)
Group B (in-stent lesion)
0.75 ± 0.10 0.67 ± 0.24 0.76 ± 0.24
0.75 ± 0.09 0.72 ± 0.20 0.75 ± 0.31
0.74 ± 0.11 0.70 ± 0.12 0.75 ± 0.10
96.5% (28/29) 83.3% (20/24) 72.2% (13/18)
94.1% (16/17) 85.7% (12/14) 80% (8/10)
91.7% (11/12) 80% (8/10) 62.5% (5/8)
75.1% 70.4%
78.6% (11/14) 70% (7/10)
70.0% (7/10) 62.5% (5/8)
95.5% 84.8% (n ¼ 29) 0% 3.4% 0% 3.4% 0% 0% (n ¼ 24) 4.2% 12.5% 0% 0% 8.3% (n ¼ 18) 0% 0% 0% 0% 0% 16.6%
100% (14/14) 90% (9/10) (n ¼ 17) 0% 0% 0% 0% 0% 0% (n ¼ 14) 7.1% 21.4% 0 0 14.2% (n ¼ 10) 0% 0% 0% 0% 0% 30%
90% (9/10) 75% (6/8) (n ¼ 12) 0% 8.3% 0% 8.3% 0% 0% (n ¼ 10) 0% 0% 0% 0% 0% (n ¼ 8) 0% 0% 0% 0% 0% 0%
a
ABI improvement 1 month (n ¼ 29) 1 year (n ¼ 24) 3 years (n ¼ 18) RC improvementb 1 month (n ¼ 29) 1 year (n ¼ 24) 3 years (n ¼ 18) Primary patency 1 year (n ¼ 24) 3 years (n ¼ 18) Secondary patency 1 year (n ¼ 24) 3 years (n ¼ 18) MAE 1 month Death Amputation AK Amputation BK MI Distal embolization TLR MAE 1 year Death Amputation AK Amputation BK Distal embolization TLR MAE 3 years Death Amputation AK Amputation BK MI Distal embolization TLR
ABI, ankleebrachial index; AK, above the knee; BK, below the knee; MAE, major adverse events; MI, myocardial infarction; RC, Rutherford classification; TLR, target lesion revascularization. a Defined as increase from baseline ABI 0.10. b Defined as increase from baseline by at least 1 category.
lesions without the disadvantage of a synthetic element such as a stent in the artery. In our experience, the technical success rate achieved was 100% despite the relatively long lesions treated. No minor embolic events, perforation, infection, dissection, renal failure, and thrombus formation were observed in our series. Additionally, MAEs at 30 days after the procedure occurred only in 2 patients (8.3%): 1 MI and 1 major amputation. The primary and secondary patency, and reintervention rate (entire cohort of patients) were similar to other study. In literature, few study show the real efficacy and safety of Jetstream with outcome up to 1 year from intervention. Zeller et al.11 used Jetstream in the treatment of 172 patientsd210 lesions
(femoropopliteal and infrapopliteal vessels) with 99% device success and MAEs at 30 days of 1%. The TLR rates at 6 and 12 months were 15% and 26% and the 1-year restenosis rate was 38.2% based on DUS imaging. The patients were complex with a high prevalence of hypertension (93.6%), diabetes (47%), renal disease (15.75%), prior lower extremity revascularization (51.2%), and documented coronary disease (16.9%). Only 7% of lesions were stented. He reported an ABI improvement from 0.59 ± 0.21 at baseline to 0.89 ± 0.27 (P < 0.05) at 12 months and RC improvement from 3.0 ± 0.9 at baseline to 1.5 ± 1.3 at 12 months (P < 0.05). Maehara et al.12 reported the JETSTREAM Calcium Study for severely calcified femoropopliteal artery
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Fig. 2. KaplaneMeier method estimates primary patency rate (and 95% confidence bands). SE, standard error.
lesion in patients with claudication and lesion with superficial calcium >90 and >5 mm in length as determined by intravascular ultrasound (IVUS). IVUS inclusion criteria were satisfied in 26 patients (45%). Visual diameter stenosis was 86 ± 9%
pretreatment, 37 ± 13% post atherectomy, and 10 ± 6% post adjunctive treatment (adjunctive PTA and stenting in 8 and adjunct PTA alone in 16). IVUS showed that the lumen area increased from 6.6 ± 3.7 to 10.0 ± 3.6 mm2 (P ¼ 0.001):
Fig. 3. KaplaneMeier method estimates secondary patency rate (and 95% confidence bands). SE, standard error.
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Fig. 4. KaplaneMeier method estimates survival rate (and 95% confidence bands). SE, standard error.
calcium reduction was responsible for 86 ± 23% of the lumen increase. Sixt et al.13 reported vessel occlusion, dissection, distal embolization, hematoma at access site, infection, perforation, pseudoaneurysm, renal failure, restenosis, and thrombus formation as complications of this device. In the Zeller
study, minor embolic events were noted in 10% of cases and 4 perforation (2%) occurred.11 He compared the results for diabetic and nondiabetic patients. There was a higher incidence of embolic events in the diabetic group (13.8% vs. 6.5%; P < 0.001). The acute procedural outcomes
Fig. 5. KaplaneMeier method estimates freedom from amputation rate (and 95% confidence bands). SE, standard error.
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were similar. At 12 months, MAE rate (death, MI, amputation, TLR, target vessel revascularization) was 25% for nondiabetic patients and 31.5% for diabetic patients. Most events were related to TLR, which occurred in 20% and 28% of the diabetic and nondiabetic groups (P ¼ not significant). An important concept is the incidence of embolization related to device use.14 Boiangiu et al.15 analyzed particulate debris retrieved with an embolic protection device (Emboshield; Abbott Vascular, Santa Clara, CA) in 22 patients with superficial femoral artery disease treated by Jetstream atherectomy. They found macroscopic debris in 95.4% patients. Shrikhande et al.16 examined the incidence of distal embolization in 2.137 lesions (1.029 patients) undergoing recanalization with Jetstream device. The embolization rate was 1.6% and it was associated not only with complex lesions but also with device type. In our study, embolic filter protection was not used, with no embolic events documenting intra- and post-procedure time. Moreover, we preferred not to use the distal filter because of the potential risk of wire entrapment on the device and potential risk of vessel spasm and dissection. As showed in the study by Shammas et al.,17 Jetstream could be useful also for the treatment of ISR. The authors evaluated the outcomes and stent device interaction of the Jetstream device in the treatment of ISR of the femoropopliteal segment in a cohort of 29 patients (32 limbs) with lesion length 17.4 ± 13.1 cm. Acute success (30% residual narrowing with no serious adverse events) was obtained in 91% of limbs (29/32) and 76% of cases (22/29) without adjunctive balloon angioplasty. There were no new stent fractures or deformities (n ¼ 24) post atherectomy. TLR at 6 and 12 months occurred in 4/29 (14%) and 12/29 (41%) patients, respectively. Even so, previous studies have showed similar efficacy and safety rate; there are no patients who show longer outcomes up to 3 years of follow-up. Moreover, most of the documented outcomes refer patients with RC class between 1 and 3. In our study, patient undergoing treatment belonged to RC between 2 and 5 showing longer follow-up time assessment (3 years) after intervention. The outcomes showed in this study are similar to those documented in the literature in terms of patency rate. Moreover, what emerged from this study was that patients who underwent atherectomy and DEB angioplasty (n ¼ 12) treatment showed a lower restenosis rate compared to those where atherectomy was associated with simple
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angioplasty at 1 year of follow-up (83.3% vs. 50%; P < 0.05). The main limitation of this study is the small size, even if it is a single center experience, and mixed patients were analyzed, resulting in the presence of bias. Moreover, this is not a randomized study and we no data were collected including Trans-Atlantic Inter-Society Consensus II classification.
CONCLUSIONS The use of the Jetstream atherectomy system during percutaneous interventions for femoropopliteal artery disease appears to be safe and feasible with no distal embolization, and low complications and favorable TLR rate. The restenosis rate was lower when the treatment was associated to DEB compared to simple angioplasty, showing encouraging outcomes at 3 years of follow-up. REFERENCES 1. Ambrose Panico DO, Asif Jafferani MD, Falak Shah MD, et al. Advances in peripheral arterial disease endovascular revascularization. Cardiol Clin 2015;33:89e98. 2. Gautam V, Shrikhande MD, James F, et al. Use and abuse of atherectomy: where should it be used? Sem Vasc Surg 2008;21:204e9. 3. Gandhi S, Sakhuja R, Slovut DP. Recent advances in percutaneous management of iliofemoral and superficial femoral artery disease. Cardiol Clin 2011;29:381e94. 4. Shammas NW, Coiner D, Shammas G, et al. Predictors of provisional stenting in patients undergoing lower extremity arterial interventions. Int J Angiol 2011;20:95e100. 5. Laird JR, Katzen BT, Scheinert D, et al., RESILIENT investigators. Nitinol stent implantation versus balloon angioplasty for lesion in superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv 2010;3:267e76. 6. Krankenberg H, Schluter M, Steinkamp HJ, et al. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation 2007;116:285e92. 7. Chalmers N, Walker PT, Belli AM, et al. Randomized trial of the SMART stent versus balloon angioplasty in long superficial femoral artery lesions: the SUPER study. Cardiovasc Intervent Radiol 2013;36:353e61. 8. Scheinert D, Scheinert S, Sax J, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol 2005;45:312e5. 9. Shammas NW. JETSTREAM atherectomy: a review of technique, tips, and tricks in treating the femoropopliteal lesions. Int J Angiol 2015;24:81e6. 10. Franzone A, Ferrone M, Carotenuto G, et al. The role of atherectomy in the treatment of lower extremity peripheral artery disease. BMC Surg 2012;12(Suppl 1):S13. 11. Zeller T, Krankenberg H, Steinkamp H, et al. One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease:
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the multicenter pathway PVD trial. J Endovasc Ther 2009;16:653e62. 12. Maehara A, Mintz GS, Shimshak TM, et al. Intravascular ultrasound evaluation of JETSTREAM atherectomy removal of superficial calcium in peripheral arteries. EuroIntervention 2015;11:96e103. 13. Sixt S, Scheinert D, Rastan A, et al. One year outcome after percutaneous rotational and aspiration atherectomy in infrainguinal arteries in patient with and without type 2 diabetes mellitus. Ann Vasc Surg 2011;25:520e9. 14. Reeves R, Imsais JK, Prasad A. Successful management of lower extremity distal embolization following percutaneous atherectomy with the JetStream G3 device. J Invasive Cardiol 2012;24:E124e8.
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15. Boiangiu C, Fissha M, Kaid K, et al. Analysis of retrieved particulate debris after superficial femoral artery (SFA) atherectomy using the Pathway Jetstream G3 device. Paper presented at: SCAI 2011 Scientific Sessions; Baltimore, Maryland. 16. Shrikhande GV, Khan SZ, Hussain HG, et al. Lesion types and device characteristics that predict distal embolization during percutaneous lower extremity interventions. J Vasc Surg 2011;53:347e52. 17. Shammas NW, Shammas GA, Banerjee S, et al. JetStream rotational and aspiration atherectomy in treating in-stent restenosis of the femoropopliteal arteries: results of the JETSTREAM-ISR feasibility study. J Endovasc Ther 2016;23:339e46.
Background: The aim of this study is to assess our experience and mid-term outcomes using Jetstream atherectomy system for treatment of femoropopliteal artery disease (FPAD). Methods: Data of 30 patients with FPAD treated at our center between 2013 and 2016 were analyzed. Two subgroups of patients were identified: Group A included patients (n ¼ 18) with de novo lesions; Group B (n ¼ 12) included those with in-stent restenosis. The primary study end points assessed were technical success, perioperative mortality, and major adverse event (MAE) rate at 30 days (distal embolization, major amputation, and target lesion revascularization). Other outcomes measured were survival, primary, and secondary patency, and freedom from amputation at 1 and 3 years of follow-up, respectively. Results: Technical success was 100% for both groups. The MAE rate was 8.7%. No distal filter was adopted during intervention. Angioplasty was associated with 93.3% of cases (93.3% vs. 100%; P ¼ 0.15), drug-eluting balloon (DEB) in 12 cases (22.2% vs. 66.6%; P ¼ 0.008), drug-eluting stent and bare metal implantation in 1 (5.6% vs. 0%; P ¼ 1) and 4 cases (11.1% vs. 16.7%; P ¼ 1), respectively. The cumulative primary and secondary patency rates were 75.1% and 95.5% at 1 year, and 70.4% and 84.8% at 3 years of follow-up, respectively. The survival and freedom from amputation were 96.4% and 85.8% at 1 and 3 years of follow-up, respectively. The freedom from target lesion revascularization was 91.7% and 83.4% at 1 and 3 years from intervention. Conclusions: The use of the Jetstream appears to be safe and feasible with no distal embolization and low rate perioperative complications. Moreover, encouraging outcomes were observed when atherectomy was associated to DEB angioplasty.
INTRODUCTION Peripheral artery disease (PAD) has become a worldwide problem. Its prevalence increases with the age and the presence of comorbidities such as
Author contribution: Vincenzo Ardita wrote the paper; Sonia Ronchey, Matteo Orrico, and Alberto Davı` collected the data; Vincenzo Pappalardo performed the statistical analysis; Stefano Fazzini and Vittorio Alberti analyzed the data; and Nicola Mangialardi gave the final approval to the article. Funding: None. Conflict of interest: The authors have no conflicts of interest. 1
Vascular Surgery Unit, Cardiovascular Thoracic Department, Hospital S. Raffaele, Vita-Salute University, Milan, Italy. 2 Unit of Vascular Surgery, Cardiovascular Thoracic Department, Hospital S. Filippo Neri, Rome, Italy.
hypertension, smoke, diabetes mellitus, and dyslipidemia. The management of PAD can be difficult when diffuse atherosclerotic burden, chronic total occlusion, presence of critical limb ischemia, and lack of adequate distal runoff are present.1 3 Department of Surgery, Circolo Hospital and Macchi Foundation, Varese, Italy.
Correspondence to: Vincenzo Ardita, MD, Vascular Surgery Unit, Cardiovascular Thoracic Department, San Raffaele Hospital, VitaSalute University, Via Olgettina, 60, 21300 Milan, Italy; E-mail: [email protected] Ann Vasc Surg 2019; -: 1–10 https://doi.org/10.1016/j.avsg.2019.04.052 Ó 2019 Elsevier Inc. All rights reserved. Manuscript received: March 1, 2019; manuscript accepted: April 6, 2019; published online: - - -
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Open repair still remains the gold standard for the treatment of PAD, but endovascular therapy has been shown to be a valid alternative overall for high risk patients or unfit to standard surgical approach.2,3 Furthermore, improvements in device technology have facilitated the treatment of complex lesions; in fact, drug eluting stent (DES) and balloon (DEB) have been shown to be superior to balloon angioplasty reducing target lesion revascularization (TLR).4e6 Lesion length, high grade of calcification, and total occlusion have been shown to predict the need for bail-out stenting. However, stenting of femoropopliteal vessels continues to carry high rate of restenosis and occlusion resulting in disappointing long-term results.7,8 An alternative approach is the excision of the obstructing arterial plaque using atherectomy devices. In randomized trials, atherectomy has been shown to reduce dissection rate and bail-out stenting,9 minimizing the stent use in longer femoral popliteal lesions. The Jetstream device (Pathway Medical Technologies, Inc., Redmond, WA) is a rotational aspiration atherectomy system that combines rotablation with aspiration capability10 offering the possibility to debulk the plaque burden within the vessel and decreasing the limitations and complications of traditional angioplasty such as elastic recoil and dissection.11 However, while in literature few articles show the real safety and efficacy of this device in the early and mid-term period, long-term outcomes are still lacking. Therefore, we describe our experience using Jetstream atherectomy system in the treatment of the femoropopliteal artery lesions, assessing the feasibility and safety of this device and showing the outcomes at 3 years of follow-up.
primary care physician office notes and duplex ultrasound (DUS). This study followed the principles outlined in the Declaration of Helsinki and used only information obtained from the review of medical records. Patients gave consent for the anonymous collection of their data on the standard consent form provided by our institution. Ethical committee approval was waived according to Italian laws.
MATERIALS AND METHODS
Follow-up
Study Population
All patients underwent preoperative physical and clinical examination, Rutherford classification, DUS, and ABI evaluation. Preoperative computed tomography angiography was performed when the stenosis or occlusions were not adequately evaluated by DUS. Postoperative imaging follow-up protocol consisted in DUS examination before discharge at 1 and 12 months, and yearly thereafter. Follow-up also included clinical examination, ABI, and RC assessment.
This is a retrospective, single center, nonrandomized study, including 30 patients, with Rutherford Categories (RCs) between 2 and 5, and mean anklee brachial index (ABI) of 0.41 ± 0.10 (range 0.3e 0.55), who underwent percutaneous treatment with Jetstream atherectomy at our institution between 2013 and 2016. Patient’s data were retrospectively reviewed from a prospectively maintained clinical database. Patient’s demographics and comorbidities are listed in Table I. Two subgroups of patients were identified: Group A included patients (n ¼ 18) with de novo lesions and Group B (n ¼ 12) included those with in-stent restenosis (ISR). Patient’s clinical information was obtained from clinic visit data, telephone calls, or referring
End Point Analyzed outcomes included technical success defined as residual stenosis of less than 30% after procedure. Other procedures, including adjunctive angioplasty or stenting, were recorded. Stenting was performed only in case of residual dissection after atherectomy and angioplasty. Specific considered clinical end points included perioperative mortality and freedom from major adverse events (MAEs) at 30 days following the treatment. MAEs were defined as any unwanted side effect of study or treatment that results in distal embolization, myocardial infarction (MI), and major amputation. Other end points assessed were primary patency defined as freedom from restenosis of 50% calculated with DUS without reintervention; secondary patency as freedom from restenosis of 50% at the time of follow-up visit after reintervention in case of restenosis or occlusion; TLR and freedom from amputation. We also analyzed survival rate, and the clinical and hemodynamic success. The first was defined by the clinical category improvement >1 on Rutherford scale at follow-up period; the second was defined by an ABI value that has improved by >0.15 at follow-up period.
Statistical Analysis The collected data were expressed as means ± standard deviation or median + interquartile ranges (25%e 75%), and percentages. Comparisons were made using a 2-tailed t-test and Pearson’s chi-squared test as appropriate. Values of P < 0.05 were considered as
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Table I. Baseline characteristics and differences between patients with de novo lesions (Group A) and those with in-stent restenosis (Group B) Patient characteristics
Overall population
Group A (de novo lesion)
Group B (in-stent lesion)
P value
N patient Age, mean (SD) Male patients BMI, mean (SD) COPD HTA CAD Stroke/TIA DM Dyslipidemia CRF Serum creatinine levels (mg/dL) Smoking AAA Previous aortoiliac surgery Antiplatelet therapy Single Double No therapy Anticoagulant ASA I II III IV ABI RC II III IV V VI Lesion localization SFA Popliteal artery SFA + popliteal artery Lesion length (cm)
30 71.5 ± 10.1 20 (66.7%) 25.1 ± 2.5 5 (16.7%) 27 (90%) 11 (36.7%) 1 (3.3%) 14 (46.7%) 27 (90%) 8 (26.7%) 1.45 ± 1.71
18 71.1 ± 9.7 13 (62.2%) 25.2 ± 2.7 4 (22.2%) 17 (94.4%) 7 (38.9%) 0 7 (38.9%) 15 (88.3%) 6 (33.3%) 1.88 ± 2.22
12 72.1 ± 9.9 7 (58.3%) 25.6 ± 2.7 1 (8.3%) 10 (83.3%) 4 (33.3%) 1 (8.3%) 6 (50%) 12 (100%) 2 (16.7%) 0.91 ± 0.25
e 0.387a 0.461b 0.988a 0.625b 0.592b 0.706b 0.400b 0.452b 0.255b 0.241b
12 (40%) 1 (3.3%) 0
7 (38.9%) 1 (5.6%) 0
5 (41.7%) 0 0
0.893b 0.572b e
20 4 5 1
(66.7%) (13.3%) (16.7%) (3.3%)
9 (50%) 4 (22.2%) 5 (27.8%) 0
11 (91.7%) 0 0 1 (8.3%)
0.023b 0.129b 0.065b 0.419b
6 (20%) 20 (66.7%) 4 (13.3%) e 0.41 ± 0.10
4 (22.2%) 12 (66.7%) 2 (11.1%) e 0.41 ± 0.09
2 (16.7%) 8 (66.6%) 2 (16.7%) e 0.41 ± 0.10
1b 1b 1b
3 (10%) 10 (33.3%) 6 (20%) 8 (26.7%) 3 (10%) n ¼ 52 30 (57.7%) 7 (13.5%) 15 (28.8%) 11.7 ± 5.1
2 (11.1%) 6 (33.3%) 4 (22.2%) 5 (27.8%) 1 (5.6%) n ¼ 29 18 (62.1%) 4 (13.8%) 7 (24.1) 9.9 ± 4.01
1 (8.3%) 4 (33.3%) 2 (16.7%) 3 (25%) 2 (16.7%) n ¼ 23 13 (56.5%) 2 (8.7%) 8 (34.8%) 14.6 ± 5.6
1b 1b 1b 1b 0.547b
0.575a
0.425b 0.631b 0.721b 0.989a
Bold values indicate statistical significance. AAA, abdominal aortic aneurysm; ABI, ankleebrachial index; ASA, American Society of Anesthesiologists; BMI, body mass index; CAD, coronary artery disease; CFR, chronic renal failure (glomerular filtration rate <40 mL/min); COPD, chronic obstructive pulmonary disease; DM, diabetes mellitus; HTA, hypertension; RC, Rutherford classification; SD, standard deviation; SFA, superficial femoral artery; TIA, transient ischemic attack. a Student’s t-test. b Chi-squared test.
significant. Primary and secondary patency rates, and freedom from reintervention and from amputation rates were reported using the KaplaneMeier method. Curves were displayed up to a value of standard error <0.10, with the 95% confidence interval also displayed. All analyses were performed using R version 3.3.0 (open source software; R Foundation for Statistical Computing, Vienna, Austria).
Technique All procedures were performed in a C-arm (Alien EAlien 3030 cardio; Eurocolumbus, Salt Lake City, UT) equipped operating room under local anesthesia (2% lidocaine) in supine position. The common femoral artery access site was studied preoperatively with DUS to exclude the presence
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Fig. 1. (A) Angiography demonstrating occluded superficial femoral artery; (B) crossing of the lesion using a 0.01400 guidewire (Asahi Intecc, Seto, Japan, made in Vietnam); (C) debulking of the lesion using Jetstream
Atherectomy System XC (Pathway Medical Technologies, Inc., Redmond, WA); (D) arteriogram demonstrating a good vessel patency achieved after atherectomy.
of stenosis and circumferential calcifications at the site of puncture. An omolateral access was chosen in 4 of 23 cases and contralateral one in the other cases. The omolateral access was gained through a short 7F percutaneous introducer sheath (Radifocus Introducer II; Terumo Corporation, Tokyo, Japan) and the contralateral access with a long 7F percutaneous introducer sheath (Flexor; Cook, Bloomington, IN). A preliminary angiography was employed to confirm the diagnosis (Fig. 1A) and subsequently a systemic heparinization was achieved with a 5,000 UI heparin bolus. Lesions were crossed with a luminal technique using a 0.01400 guidewire (Asahi Intecc, Seto, Japan, made in Vietnam) (Fig.1B). The wire was supported and directed by a 4F Bern catheter (Boston Scientific). Once the lesion was crossed the debulking of the plaque was performed with Jetstream Atherectomy System XC (Fig. 1C). An angiography was performed before device activation to document the target vessel region and the position of the device during the treatment. The device was advanced slowly (1 mm/sec) and continuously in order to avoid vessel damage. As recommended, we stopped the activation of the device every 40 sec for 20 sec. During the treatment, periodically we assess aspiration flow by observing flow through the tubing and into the collection bag. When the treatment was completed an
angiography was performed to evaluate the entire target vessel and runoff (Fig. 1D).
RESULTS A total of 52 lesions in 30 patients were treated at our institution between 2013 and 2016. No preoperative statistical differences have been recorded between the 2 groups of patients analyzed, except for antiplatelet therapy at the time of in-hospital admission. The majority of lesions were localized at the level of the superficial femoral artery (62.1% vs. 56.5%; P ¼ 0.42). The mean lesion length was 11.7 ± 5.1 cm (9.9 ± 4.01 vs. 14.6 ± 5.6; P ¼ 0.98). Twenty-nine lesions were treated in Group A (de novo lesion) and 23 in Group B (in-stent lesion). The technical success was achieved in all cases. Intraoperative details are listed in Table II. Balloon angioplasty was associated with 93.3% of patients with no differences between the 2 groups. DEB angioplasty was associated with 40% of cases, overall for patients of the second group (22.2% vs. 66.6%; P ¼ 0.008). Stent implantation was performed in 5 cases (1 DES and 4 bare metal stent) due to residual stenosis and dissection. In 6 cases (20%) the procedures were associated with the treatment of below the knee vessels (16.7% vs.
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Table II. Intraoperative characteristics Patient characteristics
Technical success Anterograde access Total duration of procedure (min) Total fluoroscopy time Total contrast administration (mL) Angioplasty DEB Number of stent used DES BMS Access complication Distal embolization Amputation BK Amputation AK Wound curettage
Overall population
Group A (de novo lesion)
Group B (in-stent lesion)
P value
100% 19 100.2 ± 34.2
100% 15 (83.3%) 104.7 ± 37.04
100% 8 (66.6%) 92.9 ± 30.3
e 0.391a 0.919b
39.9 ± 17.6 61.6 ± 26.1
38.6 ± 17.4 61.4 ± 25.9
38.1 ± 19.5 58.3 ± 26.2
0.077b 0.314b
28 (93.3%) 12 (40%)
18 (100%) 4 (22.2%)
10 (83.3%) 8 (66.6%)
0.151a 0.008a
1 (3.3%) 4 (13.3%) 0% 0% 0% 1 (3.3%) 5 (16.7%)
1 (5.6%) 2 (11.1%) 0% 0% 0% 0% 3 (16.7%)
0% 2 (16.7%) 0% 0% 0% 1 (8.3%) 2 (16.6%)
1a 1a e e e 0.400a 1a
Bold values indicate statistical significance. AK, above the knee; BK, below the knee; BMS, bare metal stent; DEB, drug-eluting balloon; DES, drug-eluting stent. a Chi-squared test. b Student’s t-test.
24.9%; P ¼ 0.14). Embolic protection system was never used. In 5 patients wound curettage was associated (16.7% vs. 16.6%; P ¼ 1). One patient of the second group underwent limb fasciotomy due to the onset of revascularization syndrome. All patients who were under single antiplatelet therapy before the treatment were discharged under double antiplatelet therapy at least for 3 months. Thirty-day Outcomes Twenty-nine patients completed 1 month of followup. The MAE rate was 8.7%: 1 patient had MI and another one underwent major amputation due to revascularization syndrome and worsening of symptoms. Both patients belonged to the second group. After the procedure, during the hospitalization time, 1 patient of the first group underwent Lisfranc amputation. No embolic events, perforation, infection, dissection, renal failure, and thrombus formation were observed. Outcomes are listed in Table III.
month, 83.3% at 1 year, and 72.2% at 3 years of follow-up, without any statistical differences between the 2 groups. Moreover, an improvement in ABI was recorder (P ¼ 0.019 and 0.15 at 1 and 3 years). The cumulative primary and secondary patency rates were 75.1% and 95.5% at 1 year, and 70.4% and 84.8% at 3 years of follow-up, respectively (Figs. 2 and 3). The differences between the 2 groups of patients analyzed are listed in Table III. The survival and freedom from amputation were 96.4% and 85.8% at 1 and 3 years of follow-up, respectively (Figs. 4 and 5). The freedom from TLR was 91.7% and 83.4% at 1 and 3 years from intervention. No differences were documented between the 2 groups of patients analyzed. Nevertheless, what we observed from the study was that patients who received atherectomy and DEB (n ¼ 12) angioplasty together showed a lower rate of restenosis compared to those where atherectomy was associated with simple angioplasty (n ¼ 12) at 1 year of follow-up (83.3% vs. 50%; P < 0.05).
Mid-term Outcomes
DISCUSSION
At mean follow-up time of 29.2 ± 17.05 months, 24 patients completed 1 year of follow-up and 18 patients completed 3 years. During this period, 1 death (unrelated to device or procedure) and 3 major amputations occurred. Mean RC improved at least 1 class from the baseline in 96.5% of patients at 1
Significant advances have been made in the vascular treatment of PAD with new technologies developed to improve the revascularization of complex vascular lesions. The Jetstream atherectomy system has the distinct advantage of removing the obstructing atherosclerotic or intimal hyperplastic
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Table III. Postoperative outcomes Patient characteristics
Overall population
Group A (de novo lesion)
Group B (in-stent lesion)
0.75 ± 0.10 0.67 ± 0.24 0.76 ± 0.24
0.75 ± 0.09 0.72 ± 0.20 0.75 ± 0.31
0.74 ± 0.11 0.70 ± 0.12 0.75 ± 0.10
96.5% (28/29) 83.3% (20/24) 72.2% (13/18)
94.1% (16/17) 85.7% (12/14) 80% (8/10)
91.7% (11/12) 80% (8/10) 62.5% (5/8)
75.1% 70.4%
78.6% (11/14) 70% (7/10)
70.0% (7/10) 62.5% (5/8)
95.5% 84.8% (n ¼ 29) 0% 3.4% 0% 3.4% 0% 0% (n ¼ 24) 4.2% 12.5% 0% 0% 8.3% (n ¼ 18) 0% 0% 0% 0% 0% 16.6%
100% (14/14) 90% (9/10) (n ¼ 17) 0% 0% 0% 0% 0% 0% (n ¼ 14) 7.1% 21.4% 0 0 14.2% (n ¼ 10) 0% 0% 0% 0% 0% 30%
90% (9/10) 75% (6/8) (n ¼ 12) 0% 8.3% 0% 8.3% 0% 0% (n ¼ 10) 0% 0% 0% 0% 0% (n ¼ 8) 0% 0% 0% 0% 0% 0%
a
ABI improvement 1 month (n ¼ 29) 1 year (n ¼ 24) 3 years (n ¼ 18) RC improvementb 1 month (n ¼ 29) 1 year (n ¼ 24) 3 years (n ¼ 18) Primary patency 1 year (n ¼ 24) 3 years (n ¼ 18) Secondary patency 1 year (n ¼ 24) 3 years (n ¼ 18) MAE 1 month Death Amputation AK Amputation BK MI Distal embolization TLR MAE 1 year Death Amputation AK Amputation BK Distal embolization TLR MAE 3 years Death Amputation AK Amputation BK MI Distal embolization TLR
ABI, ankleebrachial index; AK, above the knee; BK, below the knee; MAE, major adverse events; MI, myocardial infarction; RC, Rutherford classification; TLR, target lesion revascularization. a Defined as increase from baseline ABI 0.10. b Defined as increase from baseline by at least 1 category.
lesions without the disadvantage of a synthetic element such as a stent in the artery. In our experience, the technical success rate achieved was 100% despite the relatively long lesions treated. No minor embolic events, perforation, infection, dissection, renal failure, and thrombus formation were observed in our series. Additionally, MAEs at 30 days after the procedure occurred only in 2 patients (8.3%): 1 MI and 1 major amputation. The primary and secondary patency, and reintervention rate (entire cohort of patients) were similar to other study. In literature, few study show the real efficacy and safety of Jetstream with outcome up to 1 year from intervention. Zeller et al.11 used Jetstream in the treatment of 172 patientsd210 lesions
(femoropopliteal and infrapopliteal vessels) with 99% device success and MAEs at 30 days of 1%. The TLR rates at 6 and 12 months were 15% and 26% and the 1-year restenosis rate was 38.2% based on DUS imaging. The patients were complex with a high prevalence of hypertension (93.6%), diabetes (47%), renal disease (15.75%), prior lower extremity revascularization (51.2%), and documented coronary disease (16.9%). Only 7% of lesions were stented. He reported an ABI improvement from 0.59 ± 0.21 at baseline to 0.89 ± 0.27 (P < 0.05) at 12 months and RC improvement from 3.0 ± 0.9 at baseline to 1.5 ± 1.3 at 12 months (P < 0.05). Maehara et al.12 reported the JETSTREAM Calcium Study for severely calcified femoropopliteal artery
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Fig. 2. KaplaneMeier method estimates primary patency rate (and 95% confidence bands). SE, standard error.
lesion in patients with claudication and lesion with superficial calcium >90 and >5 mm in length as determined by intravascular ultrasound (IVUS). IVUS inclusion criteria were satisfied in 26 patients (45%). Visual diameter stenosis was 86 ± 9%
pretreatment, 37 ± 13% post atherectomy, and 10 ± 6% post adjunctive treatment (adjunctive PTA and stenting in 8 and adjunct PTA alone in 16). IVUS showed that the lumen area increased from 6.6 ± 3.7 to 10.0 ± 3.6 mm2 (P ¼ 0.001):
Fig. 3. KaplaneMeier method estimates secondary patency rate (and 95% confidence bands). SE, standard error.
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Fig. 4. KaplaneMeier method estimates survival rate (and 95% confidence bands). SE, standard error.
calcium reduction was responsible for 86 ± 23% of the lumen increase. Sixt et al.13 reported vessel occlusion, dissection, distal embolization, hematoma at access site, infection, perforation, pseudoaneurysm, renal failure, restenosis, and thrombus formation as complications of this device. In the Zeller
study, minor embolic events were noted in 10% of cases and 4 perforation (2%) occurred.11 He compared the results for diabetic and nondiabetic patients. There was a higher incidence of embolic events in the diabetic group (13.8% vs. 6.5%; P < 0.001). The acute procedural outcomes
Fig. 5. KaplaneMeier method estimates freedom from amputation rate (and 95% confidence bands). SE, standard error.
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were similar. At 12 months, MAE rate (death, MI, amputation, TLR, target vessel revascularization) was 25% for nondiabetic patients and 31.5% for diabetic patients. Most events were related to TLR, which occurred in 20% and 28% of the diabetic and nondiabetic groups (P ¼ not significant). An important concept is the incidence of embolization related to device use.14 Boiangiu et al.15 analyzed particulate debris retrieved with an embolic protection device (Emboshield; Abbott Vascular, Santa Clara, CA) in 22 patients with superficial femoral artery disease treated by Jetstream atherectomy. They found macroscopic debris in 95.4% patients. Shrikhande et al.16 examined the incidence of distal embolization in 2.137 lesions (1.029 patients) undergoing recanalization with Jetstream device. The embolization rate was 1.6% and it was associated not only with complex lesions but also with device type. In our study, embolic filter protection was not used, with no embolic events documenting intra- and post-procedure time. Moreover, we preferred not to use the distal filter because of the potential risk of wire entrapment on the device and potential risk of vessel spasm and dissection. As showed in the study by Shammas et al.,17 Jetstream could be useful also for the treatment of ISR. The authors evaluated the outcomes and stent device interaction of the Jetstream device in the treatment of ISR of the femoropopliteal segment in a cohort of 29 patients (32 limbs) with lesion length 17.4 ± 13.1 cm. Acute success (30% residual narrowing with no serious adverse events) was obtained in 91% of limbs (29/32) and 76% of cases (22/29) without adjunctive balloon angioplasty. There were no new stent fractures or deformities (n ¼ 24) post atherectomy. TLR at 6 and 12 months occurred in 4/29 (14%) and 12/29 (41%) patients, respectively. Even so, previous studies have showed similar efficacy and safety rate; there are no patients who show longer outcomes up to 3 years of follow-up. Moreover, most of the documented outcomes refer patients with RC class between 1 and 3. In our study, patient undergoing treatment belonged to RC between 2 and 5 showing longer follow-up time assessment (3 years) after intervention. The outcomes showed in this study are similar to those documented in the literature in terms of patency rate. Moreover, what emerged from this study was that patients who underwent atherectomy and DEB angioplasty (n ¼ 12) treatment showed a lower restenosis rate compared to those where atherectomy was associated with simple
Atherectomy system for peripheral artery disease 9
angioplasty at 1 year of follow-up (83.3% vs. 50%; P < 0.05). The main limitation of this study is the small size, even if it is a single center experience, and mixed patients were analyzed, resulting in the presence of bias. Moreover, this is not a randomized study and we no data were collected including Trans-Atlantic Inter-Society Consensus II classification.
CONCLUSIONS The use of the Jetstream atherectomy system during percutaneous interventions for femoropopliteal artery disease appears to be safe and feasible with no distal embolization, and low complications and favorable TLR rate. The restenosis rate was lower when the treatment was associated to DEB compared to simple angioplasty, showing encouraging outcomes at 3 years of follow-up. REFERENCES 1. Ambrose Panico DO, Asif Jafferani MD, Falak Shah MD, et al. Advances in peripheral arterial disease endovascular revascularization. Cardiol Clin 2015;33:89e98. 2. Gautam V, Shrikhande MD, James F, et al. Use and abuse of atherectomy: where should it be used? Sem Vasc Surg 2008;21:204e9. 3. Gandhi S, Sakhuja R, Slovut DP. Recent advances in percutaneous management of iliofemoral and superficial femoral artery disease. Cardiol Clin 2011;29:381e94. 4. Shammas NW, Coiner D, Shammas G, et al. Predictors of provisional stenting in patients undergoing lower extremity arterial interventions. Int J Angiol 2011;20:95e100. 5. Laird JR, Katzen BT, Scheinert D, et al., RESILIENT investigators. Nitinol stent implantation versus balloon angioplasty for lesion in superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv 2010;3:267e76. 6. Krankenberg H, Schluter M, Steinkamp HJ, et al. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation 2007;116:285e92. 7. Chalmers N, Walker PT, Belli AM, et al. Randomized trial of the SMART stent versus balloon angioplasty in long superficial femoral artery lesions: the SUPER study. Cardiovasc Intervent Radiol 2013;36:353e61. 8. Scheinert D, Scheinert S, Sax J, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol 2005;45:312e5. 9. Shammas NW. JETSTREAM atherectomy: a review of technique, tips, and tricks in treating the femoropopliteal lesions. Int J Angiol 2015;24:81e6. 10. Franzone A, Ferrone M, Carotenuto G, et al. The role of atherectomy in the treatment of lower extremity peripheral artery disease. BMC Surg 2012;12(Suppl 1):S13. 11. Zeller T, Krankenberg H, Steinkamp H, et al. One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease:
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the multicenter pathway PVD trial. J Endovasc Ther 2009;16:653e62. 12. Maehara A, Mintz GS, Shimshak TM, et al. Intravascular ultrasound evaluation of JETSTREAM atherectomy removal of superficial calcium in peripheral arteries. EuroIntervention 2015;11:96e103. 13. Sixt S, Scheinert D, Rastan A, et al. One year outcome after percutaneous rotational and aspiration atherectomy in infrainguinal arteries in patient with and without type 2 diabetes mellitus. Ann Vasc Surg 2011;25:520e9. 14. Reeves R, Imsais JK, Prasad A. Successful management of lower extremity distal embolization following percutaneous atherectomy with the JetStream G3 device. J Invasive Cardiol 2012;24:E124e8.
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15. Boiangiu C, Fissha M, Kaid K, et al. Analysis of retrieved particulate debris after superficial femoral artery (SFA) atherectomy using the Pathway Jetstream G3 device. Paper presented at: SCAI 2011 Scientific Sessions; Baltimore, Maryland. 16. Shrikhande GV, Khan SZ, Hussain HG, et al. Lesion types and device characteristics that predict distal embolization during percutaneous lower extremity interventions. J Vasc Surg 2011;53:347e52. 17. Shammas NW, Shammas GA, Banerjee S, et al. JetStream rotational and aspiration atherectomy in treating in-stent restenosis of the femoropopliteal arteries: results of the JETSTREAM-ISR feasibility study. J Endovasc Ther 2016;23:339e46.