Rotational atherectomy with adjunctive balloon angioplasty in calcified chronic total occlusions of superficial femoral artery

Abstract

Objectives

The aim was to report the mid-term outcomes of Jetstream™ rotational atherectomy device in complex femoropopliteal lesions.

Methods

Between November 2016 and April 2018, 55 patients who were treated with rotational atherectomy and adjunctive balloon angioplasty due to complex femoropopliteal lesions were retrospectively scanned.

Results

Fifty-five patients who underwent endovascular treatment with rotational atherectomy for chronic total occlusive femoropopliteal lesions were included in the study. Technical success rate was 100%. The mean age was 63 (±10.5) years. The cohort included 25 (45.4%) diabetics and 45 (81.8%) current smokers. The mean length of the lesions was 20.8 ± 11.2 cm. Chronic total occlusive lesions were detected in 35 (63.6%) patients, and mixed-type steno-occlusive lesions were detected in 20 patients (36.4%). Thirty-three (60%) lesions were moderate or severely calcified. Adjunctive balloon angioplasty was performed with plain old balloon angioplasty (POBA) on 31 (56.4%) patients and with drug-coated balloon angioplasty on 24 (43.6%) patients. After adjunctive balloon angioplasty, flow limiting dissection was observed in 20 (36.3%) patients, and 17 (30.9%) patients needed stent implantation. The Kaplan–Meier analysis method estimated that the overall primary patency rates at 12 and 24 months were 81.8% and 70.9%, respectively. Overall, secondary patency rates at 12 and 24 months were 94.5% and 80%. No statistically significant differences of 24-month primary patency and secondary patency rates were found between patients treated with drug-coated balloon angioplasty and POBA as an adjunctive therapy, even though primary patency (83.3% vs. 61.3%, p = .06) and secondary patency (91.7% vs. 71%, p = .56) rates of drug-coated balloon angioplasty were slightly higher than POBA. Patients with claudication had better primary patency (90.5% vs. 58.8%, p = .001) and secondary patency (100% vs. 67.6%, p = .004) rates than patients with critical limb ischemia at 24 months. Significant differences between patients who did and did not stop smoking were found in 24-month primary patency (57% vs. 88%, p = .007) and secondary patency (67% vs. 96%, p = .007). Six patients underwent unplanned amputation. There were eight (14.5%) mortalities during follow-up.

Conclusions

Rotational atherectomy with adjunctive balloon angioplasty has satisfactory technical success rates and mid-term outcomes. As an adjunctive method, there was no difference between drug-coated balloon angioplasty s and POBAs. Smoking cessation is always the first-step treatment to improve mid-term patency results. Patients with critical limb ischemia have worse patency results compared to the patients with claudication.

Keywords

Femoral artery atherosclerosis endovascular procedures atherectomy peripheral arterial occlusive disease angioplasty balloon

Introduction

As a result of the improvements in technology, endovascular treatment (ET) of peripheral arterial disease (PAD) has become more prominent every day, even for the worst cases. The last guideline of European Society of Cardiology and the European Society for Vascular Surgery states that ET is recommended for femoropopliteal lesions under 25 cm and may be considered for longer lesions when surgery is avoided. Although the short-term outcomes of plain old balloon angioplasty (POBA) are acceptable, due to controversies in long-term patency, new technologies are being developed.¹ In complex lesions, stent implantation rates increase due to elastic recoil and dissection after angioplasty.² Atherectomy is designed to debulk atheroma plaques and reduce these risks.³ Various types of devices are currently available. The Jetstream™ device (Boston Scientific Corporation, Marlborough, MA, USA) is an atherectomy system that combines rotational expandable blades with active aspiration.⁴ There is limited data on the outcomes of this device. In this paper, perioperative properties and mid-term outcomes of cases who underwent rotational atherectomy for complex femoropopliteal lesions in a single center were reported to contribute to the literature.

Material and methods

Study design

This is a cohort study approved by the Institutional Ethics Committee. Among ET interventions of a single center which consist of approximately 250 cases per year, 55 patients who underwent rotational atherectomy with Jetstream™ for symptomatic femoropopliteal chronic total occlusions (CTO) between November 2016 and April 2018 were included in the study. ET without atherectomy devices and with devices other than rotational ones were excluded. Data was retrospectively reviewed using the medical records.

Patients and method

Patients

All suspected patients with a history of claudication, rest pain, or ischemic foot ulcers were evaluated for risk factors, and as a result, needed modifications were implemented. Medical treatment including cilostazol and antiplatelet therapy was arranged, and the patients were educated for unsupervised exercise therapy. Patients with symptoms of Rutherford stage 3 or higher were regarded as candidates for invasive treatment, and therefore, their treatments were scheduled.

Lesion evaluation

Lesions were diagnosed by using color DUS, and computerized tomography angiography (CTA) was performed on all invasive treatment candidates. Lesions were assessed from CTA images in terms of length, extension, calcification, and number of run-off vessels for planning.

Lesion calcification that extended over 50% of total length or covered more than 180° in circumference when shorter than 50% of length was considered moderate.⁵ In order to simplify analysis, lesions were divided into two groups, i.e. mild and moderate–severe. The moderate–severe group was equivalent to Cioppa’s severe calcification definition which was used in many trials.⁶

Procedure

Informed consents were obtained from all patients. In accordance with the local reimbursement criteria, atherectomy was used only in CTO lesions in case of severe residual stenosis after predilatation.

Before the procedure, a loading dose of clopidogrel was administered. Access site and direction were chosen based on accompanying lesions. Antegrade femoral access was chosen whenever possible. A contralateral or pedal puncture was used when antegrade puncture was unsuccessful. Angiographic images including inflow and outflow arteries were taken for all patients before and after every step of the procedure.

For accompanying severe iliac stenosis or occlusions, simultaneous procedures through crossover approach were planned. Common iliac artery lesions were treated with balloon-expandable, and external iliac artery lesions were treated with self-expandable nitinol stents.

After insertion of an access catheter, a bolus of heparin (100 IU/kg) was administered, and efficacy was monitored with activated clotting time targeting a level between 200 and 250 s. The intimal tracking approach was implemented. Predilatation was performed in all cases with a POBA (Mustang®, Boston Scientific, Marlborough, MA, USA) for at least 1 min with nominal pressure (8 Atm). We rounded off the balloon size to the closest smaller whole number of healthy vessel diameter and used prolonged balloon angioplasty with rated burst pressure (20 Atm) when 1 min is not sufficient. Atherectomy was performed for the residual stenosis of over 50% to improve the effect of angioplasty. For superficial femoral artery (SFA) lesions, a 2.4 mm tip was used, and for distal SFA and popliteal artery (PA) lesions, a 2.1 mm tip was used. Subsequently, balloon angioplasty was performed with either POBA or drug-coated balloon angioplasty (DCB) (Luminor® iVascular, Sant Vicenc, dels Horts, Barcelona, Spain) depending on the physician’s discretion. The balloons that were equal to the reference diameter in size were inflated for 3 min at nominal pressure. After every step of the procedure, angiography was performed to view the in-line flow and to rule out complications. Stenotic segments were assessed using two main perspectives and additional oblique perspectives for precise evaluation. The degree of diameter stenosis in the narrowest part was calculated by an automated calculation program of the angiography device (Siemens AXIOM Artis dTA, Siemens Healthcare, Erlangen, Germany). If there was a residual stenosis more than 50%, flow limiting dissection (FLD) or perforation, prolonged balloon angioplasty with rated burst pressure was performed. When the lesion persisted despite prolonged balloon angioplasty with rated burst pressure, stent implantation was performed. Self-expandable nitinol stent grafts (Supera™, Abbott Vascular, Santa Clara, CA, USA) were used in these cases.

When patients with claudication have concomitant infragenicular lesions, they were treated simultaneously if there was only one patent tibial vessel. The tibial lesions of the patients with critical limb ischemia (CLI) were treated regardless of number of patent run-off vessels. Angiosome-based interventions were preferred. All tibial lesions were treated with DCB.

The vascular closure device was used at the physician’s discretion. After the procedure, all patients received dual antiplatelet therapy at least for six months.

Follow-up and study outcomes

Follow-up visits were planned on the first, third, and sixth month and every six months thereafter. For symptomatic patients, additional sessions were scheduled.

Target lesion restenosis was defined as significant when it was greater than 50%. All symptomatic patients with significant stenosis were referred for re-intervention. ET was chosen as the first option.

The primary outcome was primary patency (PP) rate at 24 months. PP was defined as PSVR below 2.4 at the target lesion without target lesion re-intervention.

Secondary outcomes were technical success rate, complication rate, secondary patency (SP) rate at 12 and 24 months, unplanned major amputation, improvement in RC at 12 months, 30-day mortality, and overall mortality. The factors affecting primary and secondary outcomes were investigated with further analyses.

Unplanned major amputation was defined as any amputation that was not planned before the procedure. SP was defined as PSVR below 2.4 at the target lesion after a re-intervention for re-occlusion.

Statistical analysis

Statistical analysis was performed using IBM SPSS Statistics for Mac Version 20 (IBM Corp. Released 2011, Armonk, NY). Numeric variables were summarized as the mean ± SD values. Categorical variables were evaluated by cross table analysis and shown numerically with a percentage. Student’s t-test was used for the normally distributed data measured on a continuous/interval scale, while the Mann–Whitney U test was used for the non-normally distributed data. Pearson’s correlation test was used to measure the statistical relationship between continuous variables. Kaplan–Meier curves were used to compare the outcomes of the subgroups in terms of the primary and SP. Cox regression (or proportional hazards regression) was used as a method for investigating the effect of variables on the time a specified event takes to happen. p < .05 was considered statistically significant.

Results

Patients

Patient demographics, cardiovascular risk factors, and comorbidities are presented in Table 1. The mean age of patients was 63 (±10.5), and the majority of the patients were male (85.5%) and current smokers (81.8%). Over half of the patients (61.8%) presented with CLI. Diabetes was more frequent among patients with CLI.

Table 1.

Patient demographics.

Age	All		Claudication		CLI		p value
	Mean	SD
	63	10.5
	N	%	n	%	n	%	p value
Gender (male)	47	85.5	20	95.23	27	79.41	.106
Diabetes mellitus	25	45.4	6	28.57	19	55.88	.048
Smoking	45	81.1	18	85.71	27	79.41	.56
Rutherford
III	21	38.18
IV	18	32.7
V	14	25.5
VI	2	3.6

CLI: critical limb ischemia; SD: standard deviation.

Lesion characteristics

The overall mean length of the lesions was 20.8 ± 11.2 cm. Compared to patients with severe claudication, patients with CLI had longer lesion length (16.0 ± 69 vs. 23.7 ± 12.3) (p = .011). Details are shown in Table 2.

Table 2.

Lesion characteristics.

n	All	POBA	DCB	p value
n	55	31	24	p value
Lesion location
CFA + SFA	7.27 (4/55)
SFA	58.18 (32/55)
SFA + PA	16.36 (9/55)
Run-off vessels
0
1	18.2% (10/55)	22.6% (7/31)	12.5% (3/24)	.34
2–3	81.8% (45/55)	77.4% (24/31)	87.5% (21/24)
Lesion type
CTO	63.6% (35/55)	67.7% (21/31)	58.3% (14/24)
Mixed	36.4% (20/55)	32.3% (10/31)	41.6% (10/24)	.47
Calcification
None/mild	40% (22/55)	48.4% (15/31)	29.2% (7/24)
Moderate/severe	60% (33/55)	51.6% (16/31)	70.8% (17/24)	.15
Lesion length (cm) mean ± SD	20.8 ± 11.2	22.3 ± 12.8	18.7 ± 8.5	.23

POBA: plain old balloon angioplasty; CFA: common femoral artery; SFA: superficial femoral artery; PA: popliteal artery; CTO: chronic total occlusion; SD: standard deviation.

Procedure

Twenty-two (40%) patients had additional ipsilateral lesions that were treated simultaneously. Details of the procedures are shown in Table 3.

Table 3.

Procedural information.

	n	%
Retrograde access
PA	6	10.9
Pedal	8	14.54
Crossover	20	36.4
Support catheter	39	70.9
Adjunctive interventions
POBA	31	56.4
DCB	24	43.6
Below the knee
ATA	6	10.9
PTA	5	9.1
DPA/Arch	1	1.8
FLD	20	36.3
Stent (target lesion)	17	30.9
Closure device	27	49.1
Complications
Groin hematoma	3	5.45
Ecchymosis	5	9.09

POBA: plain old balloon angioplasty; DCB: drug-coated balloon angioplasty; ATA: anterior tibial artery; PTA: posterior tibial artery; DPA: dorsalis pedis artery; FLD: flow-limiting dissection.

POBA and DCB usage rates for adjunctive therapy were similar, and there were no significant differences between patients treated with POBA and DCB in terms of age, gender, and comorbidities. Neither lesion length (22.34 ± 12.8 vs. 18.7 ± 8.5, respectively, p = .23) nor calcification severity (p = .15) differed between subgroups of POBA and DCB.

After adjunctive balloon angioplasty, FLD was observed in 20 (36.3%) patients, and 17 (30.9%) patients needed stent implantation. FLD and stent need were observed more frequently in patients treated with POBA as the adjunctive therapy (n = 15, 75% of FLD, p = .035; n = 14, 82.4% of stent need, p = .009, respectively). The mean lengths of lesions with and without FLD were similar (p = 0.259), and there was no difference in terms of calcification severity. There was no distal embolization. Immediate technical success rate was 100%.

Eight access site complications were seen during hospital stay. The median duration of hospital stay was 1 (min–max; 1–7) day. There was no mortality within 30 post-procedural days.

Follow-up

Median follow-up was 24 months (min–max: 8–36 months). The participation rates in visits at 6, 12, 18, and 24 months were 100%, 94%, 85%, and 80%, respectively.

At the 12-month follow-up visit, 48 out of 55 patients (87%) experienced improvement in Rutherford class (Figure 1).

Figure 1.

Changes in Rutherford classes through follow-up. Spaghetti diagram showed changes between baseline and final Rutherford classifications.

The Kaplan–Meier-estimated overall PP rates at 12 and 24 months were 81.8% and 70.9%, respectively. Overall SP rates at 12 and 24 months were 94.5% and 80%. Through 24 months, loss of PP was detected in 16 patients. Seven of them developed CLI and were treated with balloon angioplasty.

No statistically significant differences of 24-month primary and SP rates were found between patients treated with DCB and POBA as an adjunctive therapy (p = .06, p = .06), even though primary (83.3% vs. 61.3) and SP (91.7% vs. 71%) rates of DCB were slightly higher than POBA (Figures 2 and 3).

Figure 2.

Kaplan–Meier estimations for primary patency—balloon types. Kaplan–Meier method estimates primary patency rate of overall, plain balloon, and drug-coated balloon angioplasty (and 95% conﬁdence bands).

Figure 3.

Kaplan–Meier estimations for secondary patency—balloon types.

Thirty patients continued smoking throughout the follow-up period. Significant differences between patients who did and did not stop smoking were found in 24-month primary (57% vs. 88%, p = .007) and SP (67% vs. 96%, p = .007) (Table 4). Kaplan–Meier estimations of PP and SP rates at 24 months for these groups are given in Figures 4 and 5.

Table 4.

Follow-up data.

%	Overall (%)	POBA/DCB	p	Clad/CLI	p	Smoker/nonsmoker	p
PP 12 months	81.8	77.4/91.7		95.2/79.4		76.7/96.0
PP 24 months	70.9	61.3/83.3	.06	90.5/58.8	.001	56.7/88.0	.007
SP 12 months	94.5	90.3/95.8		100/91.2		90.0/100
SP 24 months	80	71.0/91.7	.56	100/67.6	.004	66.7/96.0	.007

POBA: plain old balloon angioplasty; DCB: drug-coated balloon angioplasty; Clad: claudication; CLI: critical limb ischemia; PP: primary patency; SP: secondary patency.

Figure 4.

Kaplan–Meier estimations for primary patency—smoking status.

Figure 5.

Kaplan–Meier estimations for SP—smoking status.

Six patients underwent unplanned amputation with a median duration of 410 days (min–max: 240–580). No significant differences were found in amputation rates either between the patients treated with POBA and DCB (p = .61) or between the patients who did and did not need stent implantation (p = .35). There were eight mortalities, and survival rates for 12 and 24 months were 89.1% and 85.45%, respectively. There was no significant difference in mortality between POBA and DCB subgroups (p = .70).

Discussion

The current study differs from previous endovascular studies with its patient population, which comprised only of patients with long, calcified CTOs of femoropopliteal level and had high rates of diabetes and smoking.^1,3,7,8 The current trial reports the outcomes of Jetstream atherectomy performed in a single center. Over half of the patients presented with CLI. The 6, 12, 18, and 24-month follow-up visits were completed by 100, 94, 85, and 80% of patients, respectively.

Mean lesion length was 20.8 ± 11.2 cm. While every lesion was calcified to varying degrees, over half had moderate-to-severe calcification. After Jetstream atherectomy, rates of POBA and DCB usage were similar. After overall analyses, the data was stratified according to the adjunctive balloon type for comparison.

Overall PP rate was 81.81%, and SP rate was 94.5% at 12 months. These results are comparable with the previous studies on Jetstream device.^3,9–11 They are also comparable with other atherectomy devices at 12 months.^5,8,12,13 PP and SP rates at 24 months were 70.9 and 80%, respectively. These results are consistent with the current literature.¹⁰

In studies on atherectomy devices, complex, long, and severely calcified lesions are frequently excluded, and the follow-up period is usually under 24 months.^8,9 It should be underlined that all of the lesions in this study had a CTO segment due to reimbursement rules. Hence, the current study has the highest severe calcification and CTO rate, with the longest mean lesion length treated with Jetstream atherectomy device.^3,9–11,14 Primary and SP rates of the study are desirable considering that hostile lesion properties are considered to be the reasons for poor outcome and complications.

Increased lesion length was one of the factors associated with poor results.¹² Therefore, the relationship between lesion length and long-term outcomes was analyzed, and a cut-off value of 217 mm was found to be related with poor 24-month PP rates (p = .02). Even though this analysis was with low sensitivity (.641) and specificity (.563), its results support previous studies showing the effect of lesion length (Figure 6).¹⁵ Nevertheless, when lesion characteristics, i.e. length, calcification, and type, were tested for their effect on outcome, multivariate analysis failed to reveal an independent risk factor. However, this may be a consequence of the small sample size.

Figure 6.

Receiver-operating characteristics (ROC) curve analysis. A cut-off value of 217 mm was found to be related with poor 24-month PP rates (p = .02).

Many studies claim that atherectomy improves results when combined with adjunctive DCB.^3,9,16 Previous studies hypothesized that removal of calcium improved the anti-proliferative effect of DCB and showed that the distribution depth increased after atherectomy.^17–19 In this study, there was no significant difference between PP and SP rates of adjunctive DCB and POBA. DCB had higher PP and SP rates at 24 months but failed to reach statistically significant difference. A further study with similar patient population with a larger sample size, and randomized controlled design is needed for more precise statements.

Decreased risk of dissection after balloon angioplasty is suggested as another benefit of calcium removal by atherectomy.^1,16 One-third of our cases had FLD, and nitinol stents were needed in a majority of them (17 out of 20, overall rate 30.9%). While there are some studies with greater dissection rates,^20–22 the rate in the current study is higher than most of the existing studies.^3,9,11,16 A risk factor for dissection was searched, and lesion characteristics were analyzed to check for any relationship with FLD. None of the characteristics, i.e. calcification degree, lesion length, and lesion type had any effect on occurrence of dissection. Shammas et al.¹¹ reported FLD rate of 13.6%. Their population has very similar properties to our cohort; however, the mean lesion length was 12 cm in their population. We may indirectly hypothesize that lesion length increases the risk of dissection; nevertheless, it was not statistically possible to put forth such a hypothesis. In a multicenter study, 1-cm increase in lesion length brought two percent increased risk of atherectomy associated complications, and atherectomy was found to be related with increased risk of dissection.²³ In RESILIENT trial, stents were needed in 40.3% of the balloon angioplasty group, and it was found that longer lesions needed stent implantations.¹ Taking into consideration that the mean length of the current study was longer than the above-mentioned studies, it is not surprising to observe these rates of FLD and stent need. Moreover, Jetstream™ atherectomy might have decreased the provisional stent rate, and this will be questioned in a following study.^3,7,9,16

Besides the main perspective that atherectomy is beneficial, there are studies contradicting this. Maehara et al.²⁰ evaluated the effect of Jetstream™ atherectomy on a luminal surface by using intravascular ultrasound. After Jetstream™ atherectomy, a more concave and smoother surface was detected with a small increase in lumen area. When balloon angioplasty was combined to increase lumen gain, lumen area almost doubled in exchange for threefold increase in dissection rates. Another study demonstrated that intima media thickness increased after atherectomy plus balloon angioplasty compared with balloon angioplasty alone and claimed that this was a result of deep atherectomy cuts stimulating neointimal hyperplasia.¹⁷ Ramkumar et al.²⁴ investigated the clinical consequences of balloon angioplasty, stents, and atherectomy and underlined that major amputation rates increased by 51% in patients treated with atherectomy compared to those treated with stents. In this cohort, amputation rates were not compared due to low event rate, and primary and SP rates at 24 months showed no significant differences between the stented group and others.

The patients who presented with CLI had worse primary, SP, and survival rates compared to the patients with severe claudication. These are expected as CLI is an indicator of disease severity; however, the importance of clinical findings cannot be emphasized enough. Although not every patient may have such chance as some may already have CLI when first admitted to hospital, in general, the patients should urgently be treated when they presented with severe claudication before the symptoms progresses to CLI stage. Another important issue is smoking cessation. In our experience, only one-third of smokers succeeded in quitting and had better primary and SP rates at 24 months. Even though this is predictable, one should always keep in mind that risk modification is as important as device or technique choice. While controversies on the best treatment technique proceed, this report reminds us that the most important thing may be prevention and timing. Simply, regardless of the technique and lesion type, patient’s initial status and adaptation to therapy seem to tip the balance.

Debate over long femoropopliteal lesions restarts with every development, and it is still difficult to claim the superiority of one technique. However, theories gather around similar topics: (1) outcomes of POBA alone are not desirable; (2) stenting of infrainguinal lesions is controversial; (3) for adjunctive balloon after atherectomies, DCB seems to be a better option; (4) atherectomy increases the effect of the drug and improves the outcomes by removing calcium from the arterial wall. The current literature is far from defining the best technique for specific groups of patients, and large randomized controlled studies are obviously required. From a broad perspective, for percutaneous treatment of long severely calcified femoropopliteal CTO lesions, atherectomy with adjunctive DCB predominates which our cohort failed to support. Jetstream™ atherectomy showed comparable results in this group of patients with the most difficult lesions. Although the BASIL trial revealed that prior ET may affect the long-term outcomes of subsequent surgical intervention, it has been previously concluded that ET would not jeopardize subsequent surgical results when performed appropriately.^25,26 There is also a tendency toward ET as patients with PAD have many comorbidities, and vein grafts are frequently insufficient. Nevertheless, it is not possible to make a conclusion as to whether subsequent surgery is influenced by ET as we have not experienced any need for surgery in this cohort. In addition to this, all of the patients who presented with symptoms of CLI during 24-month follow-up were treated in an endovascular manner, and none of them needed femoropopliteal bypass as a result of procedural failure. This underlines that ET is adequate and preferable as it is easy to use, and its implementation can be repeated.

Our study has several limitations, which are non-randomized retrospective design with small sample size and single-center cohort with short follow-up period.

In conclusion, our study revealed that Jetstream™ atherectomy with adjunctive balloon angioplasty has satisfactory technical success and mid-term outcomes. Although, in our study, the presence of FLD and the need for stent implantation continued, this result remained acceptable considering the complexity of the patient population. Nonetheless, randomized controlled studies with larger sample size are required to confirm these favorable results.

Contributions

AYE (Study design, Data collection, Data analysis and Writing); OS (Study design, Data collection, Data analysis and Writing).

Footnotes

Acknowledgements

The material has not been previously published or submitted elsewhere for publication and will not be sent to another journal until a decision is made concerning publication by Vascular.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iDs

Aysen Y Engin

Onur Saydam

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