Infrainguinal cutting balloon angioplasty in de novo arterial lesions
Article Outline
Background
This prospective, non-randomized study evaluated the short- and mid-term feasibility, safety, primary patency, and limb salvage of cutting balloon percutaneous transluminal angioplasty (CB-PTA) for the treatment of peripheral arterial occlusive disease (PAOD).
Methods and Results
All data were collected for 128 consecutive patients who underwent CB-PTA to improve infrainguinal arterial circulation between January 2003 and July 2007. One-hundred thirty-five limbs with PAOD (claudication, n = 19; critical limb ischemia [CLI], n = 116) were treated. Patency was evaluated by clinical examination and duplex ultrasonography. A total of 203 lesions (183 stenoses, 20 occlusions) were treated in 66 femoropopliteal and 69 infrapopliteal arterial segments. The TransAtlantic Inter-Societal Consensus (TASC) classification of the primary lesions was A in 41.5%, B in 45.2%, C in 8.2%, and D 5.1%. Mean follow-up was 16.1 ± 9.7 months. The overall technical success rate was 96.3% and the complication rate was 8.9%. There were two (1.5%) perioperative deaths. The primary patency rate was 82.1% at 12- and 24-months in patients with claudication (femoropopliteal lesions). The 1- and 2-year results for femoropopliteal and infrapopliteal lesions in patients with CLI were: primary patency 64.4% and 51.9 %, respectively; limb salvage 84.2% and 76.9%; survival 92.6% and 88.5%. More distal lesions and TASC classification were significant independent risk factors for outcome (P < .05). Treatment of multiple segment lesions was an independent predictor of a favorable outcome (P = .04).
Conclusion
CB-PTA is safe and feasible for the treatment of infrainguinal arterial occlusive disease, with relatively low mid-term restenosis rates compared to other endovascular treatments. However, these data cannot be extrapolated to potential outcomes for lesions >10 cm in length. Further follow-up will be necessary to evaluate the long-term results of CB-PTA.
The role of percutaneous transluminal angioplasty (PTA) has been established in the treatment of claudicant patients with focal femoropopliteal disease during the past decade.1, 2 In a cost-effectiveness analysis, PTA was found to be the preferred initial treatment in patients with disabling claudication due to femoropopliteal arterial disease,3 in spite of some concern over the need for repeat PTA and surgical revascularization to treat restenosis. PTA is safe and feasible in patients with critical limb ischemia (CLI).4 Data from the bypass vs angioplasty in severe ischemia of the leg (BASIL) trial show the similar ability of bypass surgery and balloon angioplasty to preserve both life and limb short-term.5 However, elastic recoil and vessel wall injury during dilation after infrainguinal PTA for peripheral arterial occlusive disease (PAOD) may be a cause of limited durability of angioplasty.
Cutting balloons (CB) are relatively new devices designed for the percutaneous treatment of recurrent stenosis due to neointimal hyperplasia within coronary artery stents.6, 7 The catheters have three or four microsurgical blades mounted longitudinally on the balloon which cut directly into the stenotic lesion during initial balloon inflation. Cutting balloon percutaneous transluminal angioplasty (CB-PTA) induces mechanical and biological effects to reduce elastic recoil, vessel wall injury and potentially to reduce restenosis. Compared to PTA, CB-PTA has been shown to be effective in decreasing the inflammatory response,8 endothelial damage,9 proliferative response,7 and to achieve larger lumen areas.10 CBs are used increasingly in settings where neointimal hyperplasia is present, particularly in hemodialysis fistula stenoses but more recently with other graft anastomoses. With such new technology, there is a tendency to reserve its use for stenoses resistant to standard techniques.
The aim of this study was to evaluate the short- and mid-term outcomes in terms of feasibility, safety, primary patency, and limb salvage of CB-PTA used as primary “sole therapy” for the treatment of PAOD.
Methods
Patients
Data were collected prospectively on all consecutive patients who underwent CB-PTA to improve infrainguinal arterial circulation between January 2003 and July 2007. Exclusion criteria included concomitant or sequential treatment of iliac lesions, and patients who underwent concomitant aortoiliac or infrainguinal open bypass surgery. During the same period, no other forms of infrainguinal angioplasty were performed.
The peripheral artery disease was evaluated by clinical examination, ankle-brachial index (ABI) measurements, duplex ultrasonography, and lower limb angiography in all patients. Lesions causing a diameter reduction of at least 50% on ultrasonography were considered to be hemodynamically relevant. The occlusive lesions in the lower extremities were classified by angiographic findings according to the TransAtlantic Inter-Societal Consensus (TASC).11
Stent placement was limited to patients with dissection of femoropopliteal occlusive lesions after CB-PTA. No stent was placed in infrapopliteal lesions.
The criteria for open bypass surgery as the primary treatment for PAOD was long (≥10 cm) arterial occlusion. Chronic CLI (Fontaine stages III or IV, Rutherford stages IV-VI) was defined by persistently recurring rest pain requiring regular analgesia for more than 14 days or by nonhealing ulceration or gangrene of the foot or toes.
Intermittent claudication patients (Fontaine stage IIb, Rutherford stage III) with femoropopliteal lesions required intervention in the case of an incapacitating claudication interfering with work or lifestyle after correction of risk factors, exercise rehabilitation programs and optimal medical therapy failure.
Technique
Angioplasty was performed in the operating room. The arterial access site was chosen to guarantee the best accessibility to the lesion: ipsilateral or contralateral femoral approach using various sizes of introducer sheaths ranging from 6F to 7F. Femoral artery cutdown was performed in case of failure of a percutaneous approach. Administration of a 0.5 mg/kg bolus of heparin was performed routinely after insertion of the introducer sheath. To define the anatomy, diagnostic arteriography was performed routinely before intervention. The lesion was crossed using a 0.035-inch hydrophilic guide wire (Terumo Europe, Leuven, Belgium). The guide wire was exchanged for a dedicated 0.018-inch or 0.014-inch guide wire. CB-PTA was performed with a CB selected to match the length of the lesion and the diameter of the artery: the size range from 2 to 6 mm in diameter and 10 to 20 mm in length. We undersized the cutting balloon for the first angioplasty and then we selected a greater CB diameter if necessary. No oversizing was ever performed. CB-PTA was performed with one to two overlapping inflations (maximum pressure of 8 atm) and included the entire length of each stenotic lesion. CB inflation and deflation have to be performed gradually to allow extrusion and refolding of the blades in and from their protective sleeves and to avoid tangling of the microsurgical blades. All the CB-PTA were performed without predilatation. In the average of an occlusion that we were traversing, to know if it was transluminal or subintimal a control angiography via a catheter angiography was performed, after that the target occlusion was traversed. CB-PTA was only performed if the lesion was traversed transluminally.
Control arteriography was performed after each CB-PTA and included the CB-PTA site and runoff vessels for assessment of potential complications such as vasospasm, dissection, thrombosis, or embolism. A significant dissection was present if extraluminal dye was present for a length of greater than 15 mm.
After CB-PTA, double antiplatelet treatment (aspirin 75 mg and clopidogrel) was administered if there were no contraindications for 1 month and then a single antiplatelet treatment (aspirin 75 mg or clopidogrel 75 mg) was administered routinely.
Criteria for success and follow-up
Success of PTA was defined anatomically, hemodynamically, and clinically according to the Society for Vascular Surgery and International Society for Cardiovascular Surgery reporting standards.12, 13 (1) PTA was deemed technically successful if there was <30% residual stenosis; (2) PTA was considered as a clinical success/improvement if the symptoms improved by at least one category together with an increase in ABI of >0.10 (this constitutes primary clinical success instead of continued or corrected clinical success after successful reintervention); (3) patency was determined by duplex scans, ABI measurements, or both; (4) all revisions performed on the basis of the criteria described previously or occlusion at any lesion on the same limb were considered primary PTA failures; and (5) all analysis was performed on an intent-to-treat basis, including initial technical failures.
Patients were usually seen within 4 weeks after the procedure. Postoperative follow-up (clinical examination, ABI measurements, and serial duplex ultrasonography scanning) was conducted every 3 months during the first postoperative year and every 6 months thereafter.
Data analysis
The entire cohort was analyzed, as were subgroups of patients with limiting claudication and those with CLI. All the patients were analyzed in intention to treat and, therefore, patients treated by a subsequent bypass were considered to be a CB-PTA failure. Outcomes were analyzed using Kaplan-Meier life-table analysis, the log-rank test for survival curves, and the one-sample t test. A Cox proportional hazard model was used to determine whether presentation and level of disease were independent predictors of outcome. Statistical significance was defined as a P value < .05.
Results
Demographic information
One-hundred thirty-five limbs in 128 consecutive patients (87 men, 41 women; mean age, 71.7 ± 10.4 years) with PAOD (claudication n = 19; CLI n = 116) were treated by CB-PTA (Table I). All patients were primary cases. During the same period no patients received standard balloon angioplasty and/or stenting for infrainguinal lesions and infrainguinal bypasses were performed in 156 patients. Indication for open surgery was an occlusion longer than 10 cm or failure of CB-PTA for all lesions <10 cm in length. The prevalence of risk factors of atherosclerosis in our CB-PTA cohort varied from 14-83.6%, as shown in Table II. Of these patients, 93 (72.6%) had diabetes, 18 (14%) had renal disease, 107 (83.6%) had arterial hypertension, 57 (44.5%) were smokers, and 95 (74.2%) had hyperlipidemia.
Table I. Characteristics of the 135 limbs treated with CB-PTA
| n | % | |
|---|---|---|
| Indication for CB-PTA | ||
 Claudication | 19 | 14 |
| Critical limb ischemia | 116 | 86 |
| No. of lesions treated | ||
| 1 | 80 | 59.2 |
| 2 | 42 | 31.1 |
| 3 | 13 | 9.7 |
| Most distal artery treated | ||
| Femoropopliteal arteries (Femoropopliteal group) | 66 | 48.9 |
| Infrapopliteal arteries (BelowKnee group) | 69 | 51.1 |
| TASC classification | ||
| Type A | 56 | 41.5 |
| Type B | 61 | 45.2 |
| Type C | 11 | 8.2 |
| Type D | 7 | 5.1 |
Table II. Characteristics of patients treated with CB-PTA for de novo peripheral arterial lesions
| n | % | |
|---|---|---|
| Arterial hypertension | 107 | 83.6 |
| Hyperlipidemia | 95 | 74.2 |
| Diabetes mellitus | 93 | 72.6 |
| Smoking | 57 | 44.5 |
| Chronic renal failure | 18 | 14 |
Altogether, 203 infrainguinal lesions (183 stenoses, 20 occlusions) were treated (Table I). The most distal affected arteries treated with angioplasty were the superficial femoral and/or popliteal artery in 66 patients (48.9%; Femoropopliteal group), and the infrapopliteal arteries in 69 (51.1%; BelowKnee group).
In the BelowKnee group, concomitant proximal angioplasty was performed on 14 limbs (20.3%): in the superficial femoral artery in seven (10.1%), in the popliteal artery in four (5.8%), and in the superficial femoral and popliteal artery femoropopliteal segment in three (4.4%); whereas in 55 limbs (79.7%) only the infrapopliteal arteries were treated by PTA. The mean length of all treated segments was 13.65 ± 6.1 mm (range, 4-70 mm).
Initial success and early complications
An open approach of the femoral artery was performed in 13% of the cases. Most of the surgical approaches were performed at the beginning of our experience. All 203 infrainguinal lesions were dilated successfully. The primary angiographic success rate for CB-PTA of stenoses and occlusions was 96.3%. Procedural mortality, defined as death within 30 days of the procedure, was 1.5% (2/128 patients). The 30-day mortality was always related to the overall medical condition of the patient. Seven limbs (5.2%) underwent major amputation within 30 days.
Intimal dissection occurred in five (3.7%) cases. In order to maintain arterial blood flow, dissection of the popliteal artery was treated successfully with an extended inflation time with a non-cutting balloon (n = 1), artery dissection in the superficial femoral artery was treated by implantation of two stents (Wallstent, Boston Scientific, Natick, Mass) (n = 2), and artery dissection in the superficial femoral artery was treated by implantation of two covered stents (Viabahn, W. L. Gore & Associates, Flagstaff, Ariz) (n = 2). CB-PTA required stent implantation in only four (2.9%) cases. In a case of a severe calcified lesion, one post-CB-PTA leak occurred without causing any morbidity. Four groin hematoma that did not require surgical treatment occurred. Two postoperative surgical site infections required surgical treatment. Hence, the overall complication rate was 8.9% (n = 12).
Mid-term success
The mean follow-up was 16.1 ± 9.7 months (range, 1-75 months). Two patients (1.5%) were lost to follow-up. The overall survival rate for CLI at 1- and 2-years was, respectively, 92.6% and 88.5%. Primary CB-PTA was followed by subsequent open bypass surgery in 11 limbs (8.1%) for the purpose of limb salvage. A subsequent bypass was performed if the critical ischemia was persisting or recurring whether the target stenosis remains patent or not. And therefore, the time between CB-PTA and subsequent bypass was very different for all the patients ranging from 1 day to 6 months after CB angioplasty. A total of 20 limbs (14.8%), including five within 30 days after PTA, underwent major amputation. Of these 20 limbs, no distal bypass surgery was attempted because of unreconstructable distal vessels (9) or advanced gangrene and/or infection (4) or lack of autologous venous grafts (5).
The overall primary patency rates at 1- and 2-years were 64.4% and 51.9%, respectively (Fig 1). In the subgroup claudication (n = 19), the primary patency rates at 1- and 2-years were 82.1% (Fig 2). In the CLI subgroup (n = 116), the primary patency at rates 1- and 2-years were 64.4% and 51.9%, respectively (Fig 2); the limb salvage rates at 1- and 2-years were 84.2% and 76.9%, respectively.
Fig 1.
Kaplan-Meier life-table analysis of overall primary patency rate. S.E., Standard error.
Fig 2.
Kaplan-Meier life-table analysis of primary patency according to clinical stage of patients. CLI, Claudication or critical limb ischemia; S.E., Standard error.
In the BelowKnee group, the primary patency rates at 1- and 2-years were 59.7% and 42.6%, respectively (Fig 3). In the Femoropopliteal group, the primary patency rates at 1- and 2-years were 75.2% (Table III, Fig 3).
Fig 3.
Kaplan-Meier life-table of primary patency with the most distal affected arteries treated. FP, femoral superficial or popliteal artery; BK, below the knee artery; S.E., standard error.
Table III. Outcomes of limbs treated with CB-PTA for de novo peripheral artery lesions in each subgroup (Kaplan-Meier life-table analysis)
| n | % | Primary patency (%) | Limb salvage (%) | |||
|---|---|---|---|---|---|---|
| 12 months | 24 months | 12 months | 24 months | |||
| Overall | 135 | 100 | 64.4 | 51.9 | ||
| Claudication group | 19 | 14.1 | 82.1 | 82.1 | ||
| Critical limb ischemia group | 116 | 85.9 | 64.4 | 51.9 | 84.2 | 76.9 |
| Femoropopliteal group | 66 | 48.9 | 75.2 | 75.2 | ||
| BelowKnee group | 69 | 51.1 | 59.7 | 42.6 | 80.2 | 70.2 |
Statistical analysis
More distal lesions significantly decreased the primary patency rate (P = .0268). Patients with TASC type C or D had significantly decreased primary patency rates (P = .0475) (Fig 4). The primary patency rate also increased with the number of segments treated (P = .0407) (Fig 5). Arterial hypertension (P = .086) and chronic renal failure (P = .059) were not statistically significant factors.
Fig 4.
Kaplan-Meier life-table analysis of primary patency according to TASC classification. S.E., Standard error.
Fig 5.
Kaplan-Meier life-table analysis of primary patency in patients with one or more than one segment treated. S.E., Standard error.
Discussion
Endovascular treatment of infrainguinal lesions has long been hindered by suboptimal patency rates. Conventional angioplasty in particular has been limited by high dissection rates and vascular recoil. Despite technical balloon modifications and variations in technique, there has been little progress in defeating the process of restenosis.
The current study demonstrates a high degree of technical success with CB-PTA used on a wide selection of infrainguinal lesions. Angioplasty of infrainguinal lesions has traditionally achieved technical and hemodynamic success in >80% of cases.14 The technical success rate seen with CBs in this trial was 96.3%, and significant dissection was seen in only 3.7% of patients treated. Significant dissection rates in contemporary studies of angioplasty have been reported to occur at a higher frequency than that observed in our cohort.15
A few studies have reported the results of CB-PTA for infrainguinal de novo arterial stenosis. The most important series was that of Ansel et al,16 who reported procedural outcomes at a mean of 1-year of follow-up in 73 patients with symptomatic lower limb ischemia. In their series, 89.5% of threatened limbs were salvaged. This result is similar to the rate described in our report, but a higher rate of adjunctive stenting (20%) was required due to severe intimal dissection or inadequate hemodynamics. Rabbi et al,17 reported a series of 11 patients, with a primary angiographic success rate for CB-PTA of 90.9%, a primary patency rate at 3 months of 88%, and 100% of threatened limbs salvaged. Amighi et al,18 reported the results of a randomized controlled trial comparing PTA and CB-PTA in superficial femoropopliteal artery lesions: CB-PTA did not prove to be superior to conventional PTA. The relatively small patient sample (43) and from the relatively short follow-up period (6 months) in their study has to be recognized as a limitation and, furthermore, the patient-reported walking distance is not as objective as standardized treadmill test results.
Conventional angioplasty in the superficial femoral artery and popliteal arteries for claudication has been shown to have a patency rate of 37% at 1-year,19 whereas CB-PTA resulted in a 1-year primary patency rate of 82.1%. The limitations of conventional angioplasty of femoropopliteal occlusive disease have led to the increasing use of stents in an effort to achieve better outcomes. Despite the use of stents, Schillinger et al,19 in a controlled prospective trial, reported primary patency rates of only 63% at 1-year whereas CB-PTA resulted in a 1-year primary patency rate of 82.1%. The aggressive neointimal response to stent implantation is well-understood, and problems such as stent fracture and inflammatory reactions to endografts have been reported. In our study, CB-PTA required stent implantation in only 2.9% of cases. The use of a coated stent did not make a significant difference in reducing target vessel failure in de novo native femoropopliteal artery lesions compared to the use of uncoated stents.20
The role of angioplasty for CLI is still controversial. However, the clinical advantages of angioplasty are well established for the high-risk, elderly, and vascularly-compromised patient: there is no need for general anesthesia, and complication and mortality rates are low.21 Despite a high percentage of restenosis, PTA was reported to result in a high rate of limb salvage. Our initial experience with conventional angioplasty in the infrainguinal arteries for CLI was disappointing because of poor primary patency. Our results with CB-PTA for stent restenosis, in lesions resistant to standard balloon angioplasty and for infrainguinal vein bypass graft stenosis, have incited us to use CB-PTA in de novo infrainguinal arterial lesions in order to prevent restenosis. We initially limited the indication for CB-PTA to patients unsuitable for open surgery. Our promising results with CB-PTA have led us to consider CB-PTA as a first-line procedure in patients with CLI whenever possible (with multiple staged stenosis or occlusion less than 10 cm in length) and to not limit the indication for CB-PTA to patients who cannot undergo surgery. As a consequence, bypass surgery is now considered as a second-line procedure after PTA failure. Conventional angioplasty in the infrainguinal arteries for CLI has been shown to have a restenosis rate of >65% at 2-years,22 whereas CB-PTA showed a restenosis rate of >48% at 2-years. One prospective study with lower limb ischemia reported that PTA and bypass surgery achieved the same limb salvage rate of 76% at 1-year.23 Our study reports a higher limb salvage rate at 1-year (84.2%) than for PTA. Additionally, failure of CB-PTA or PTA does not preclude the possibility of performing subsequent bypass grafting.
Several potential mechanisms of action may have contributed to the CB results obtained in this study. The degree of vascular injury and dissection seen after angioplasty has been strongly linked to restenosis. It stands to reason that if the vascular injury is more localized for achieving vessel dilation, angioplasty would therefore be accompanied by less reactivity. Theoretically, this device induces a smaller degree of vessel wall injury localized to the area of incision and sparing the interincisional segments. The response of the artery to balloon dilation can be divided into four phases, each of which contributes to restenosis: (1) the mechanical phase, which may be complicated by early elastic recoil; (2) the thrombogenic phase, which is characterized by mural thrombus formation secondary to local hemorrhage and thrombosis; (3) the proliferative phase, which is typified by neointimal hyperplasia; and (4) the remodeling phase, with pathological changes in the cellular and protein content of the media and adventitia.
The fact that more than one vessel were recanalized in the same setting could be an explanation for a better outcome or improved results. The aim for performing CB-PTA of more than one lesion is to improve the run-off and, therefore, decreases the risk of restenosis related to the fact that poor runoff was reported as a variable predicting restenosis.24
Therapeutic anticoagulation and antiplatelet therapy are used to prevent thrombosis during the thrombogenic phase. CB-PTA has been shown to decrease the inflammatory8 and proliferative responses,9 and also decreases endothelial damage leading to faster endothelialization.7 Furthermore, it has been shown that CB-PTA increases in patent lumens caused by either positive remodeling or plaque reduction.10 This was suggestive of an additional mechanism of CB-plaque reduction, which was also contributed to the larger lumen areas when CB-PTA was compared with PTA before stent placement. Thus, the association of antiplatelet therapy and CB-PTA could reduce the negative side-effects of the four phases that contribute to restenosis due to the response of the artery to balloon dilation.
One concern regarding endovascular angioplasty is its uncertain durability, and whether patients will become clinically worse than they were before the procedure in the event of target site restenosis or occlusions. CB-PTA compared with subintimal angioplasty or PTA with stenting can maintain the collaterals within the segments proximal and distal to the stenosis open and could prevent patients from becoming clinically worse than they were before the procedure (Fig 6).
Fig 6.
Recanalization by CB-PTA of the anterior tibial artery, pedal artery, and fibular artery leading to restoration of posterior tibial artery outflow and retention of open collaterals.
The CB should be used with caution due to possible complications caused by its unique design. The greatest cause for concern after CB-PTA is vessel rupture, but this has been reported rarely after arterial CB-PTA. In the coronary global randomized trial,25 the incidence was 0.8% (5/689 patients) compared with 0% after standard coronary angioplasty. In accordance with the instruction manual, dilation as well as deflation should be performed slowly to allow extrusion and refolding of the blades in and from their protective sleeves. If not performed according to instructions, blade dislodgement may occur. Garvin et al,26 showed a higher complication rate with CB-PTA for infrainguinal vein bypasses. Infrainguinal vein bypass stenosis is very different from infrainguinal arterial stenosis and thus may be associated with a higher rate of complications. Furthermore, the choice of the diameter of the cutting balloon requires prudence: oversizing with cutting balloon correlates with greater risk of rupture than standard balloon.
Our statistical analysis indicated that more distal lesions and TASC type C or D were significant independent predictors of worse long-term results. On the other hand, the greater the number of segments treated (>1) the higher the primary patency rate.
The cost of the CB ($800 US) is higher than standard balloon but less than peripheral stent. In our experience, the CB-PTA may be cost-effective related to the fact that associated with a lower rate of restenosis and, therefore, associated with a lower rate of reintervention.
These data demonstrate that the CB is a safe and feasible option for the treatment of infrainguinal arterial occlusive disease with relatively low mid-term restenosis rates compared to other types of endovascular treatment. Furthermore, failure of CB-PTA does not preclude the possibility of performing subsequent bypass grafting. However, these data cannot be extrapolated to potential outcomes for lesions >10 cm in length. Further follow-up will be necessary to evaluate the long-term results of CB-PTA.
Author contributions
References
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Competition of interest: none.
PII: S0741-5214(08)01043-4
doi:10.1016/j.jvs.2008.06.053
© 2008 The Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.
