Peripheral Chronic Total Occlusions Treated with Subintimal Angioplasty and a True Lumen Re-Entry Device

ABSTRACT: Objective. We sought to verify how effective the Pioneer catheter (Medtronic, Inc., Minneapolis, Minnesota) is in overcoming the complexity of re-entry during subintimal angioplasty and provide a case series describing the technique. Background. Subintimal angioplasty is effective in treating peripheral chronic total occlusions (CTO). However, this technique is often limited by the inability to re-enter the true lumen after subintimal crossing of the occluded segment. The Pioneer catheter was the first device to address this difficulty associated with subintimal angioplasty. Methods. A retrospective review of 21 consecutive cases of peripheral CTOs requiring use of the Pioneer catheter were reviewed. The patients’ demographics, indications for the procedure, location and extent of occlusion, lesion characteristics, technique, procedural success and complications were recorded. Results. Twenty of 21 cases were procedurally successful (defined as ≤ 30% post-procedure stenosis), for a rate of 95%. The most commonly occluded vessels were the common iliac artery and the superficial femoral artery. The average occlusion length was 107 mm (standard deviation = 87) with a range of 23–300 mm. Both antegrade and retrograde approaches were successful. There was only 1 complication in the study population. Conclusions. The Pioneer catheter is a re-entry device that is versatile and improves success rates of subintimal angioplasty, which may lead to improvement in the care of patients with CTOs. The cases series demonstrates the use of the Pioneer catheter in treating CTOs. J INVASIVE CARDIOL 2009;21:468–472 Chronic total occlusions (CTO) are a challenging subset of peripheral vascular lesions encountered by endovascular interventionalists. Subintimal angioplasty is one technique initially described by Bolia et al in 1990, which addressed this challenge.1 This technique involves intentional subintimal dissection across the CTO with re-entry into the true lumen distal to the occlusion. Subintimal angioplasty is effective in treating lesions located anywhere between the iliac, popliteal or tibial arteries.2–5 However, this technique is often limited by the inability to re-enter the true lumen after subintimal crossing of the occluded segment, which remains the primary cause for acute procedural failure in the treatment of CTOs.6,7 Catheters allowing for passage of a needle and guidewire across the intima distal to the occlusion were developed to overcome this obstacle. True lumen re-entry catheters have been shown to be an effective method of gaining access back into the true lumen and facilitating successful endovascular treatment of CTOs that would otherwise have required surgical bypass.6–9 The Pioneer catheter (Medtronic, Inc., Minneapolis, Minnesota) was the first device to address this difficulty associated with subintimal angioplasty. The catheter is 6.9 French (Fr) and is thus compatible with a 7 Fr sheath. The catheter is a monorail system and requires two guidewires: a 0.014 inch guidewire for catheter positioning and another 0.014 inch guidewire for the needle lumen. The curved needle at the end of the catheter may be advanced to an adjustable depth. The length of the catheter is 120 cm. This device is integrated with intravascular ultrasound (IVUS) to allow for real-time imaging at time of needle deployment for re-entry into the true lumen. Both the IVUS and curved needle are radiopaque, allowing easy visualization on fluoroscopy. The objective of this study was to determine how effective, safe and versatile the Pioneer catheter is in overcoming the difficulty of re-entry during subintimal angioplasty and to provide a case series describing the technique. Methods A retrospective review from a database of peripheral catheterization cases at a single center identified 21 consecutive cases of peripheral CTOs requiring the use of the Pioneer catheter. The charts for the 20 patients (1patient had 2 CTOs treated) were reviewed. The patients’ demographics (age, gender, cardiovascular risk factors), indication for the procedure, location and extent of occlusion, technique, procedural success and complications were recorded. Indications for the procedures were categorized as intermittent claudication alone or intermittent claudication and critical limb ischemia. The lesions were categorized by using the Trans-Atlantic Inter-Society Consensus II (TASC II) classification system,10 which sorts the lesions into four categories (A, B, C, D). Class A CTOs are infrainguinal lesions 150 mm not involving the infrageniculate popliteal artery. Class D CTOs are aortoiliac lesions, unilateral CIA and EIA lesions, bilateral EIA lesions, or infrainguinal lesions either > 200 mm or involving popliteal and proximal trifurcation vessels. The lesions were also described as being either ostial or not, and whether the occlusion was tapered versus abrupt. Procedural success was defined ≤ 30% residual stenosis in the area of the CTO compared to areas of normal vessel. Complications were defined as any adverse event occurring within 24 hours and as a direct result of the index procedure. Use of the Pioneer catheter initially requires subintimal passing of the CTO. The device is then inserted into the subintimal track past the CTO. The true lumen is identified with IVUS and then the catheter is manipulated until the true lumen is oriented to the 12 o’clock position. IVUS then allows direct visualization of needle deployment ensuring accurate re-entry of the true lumen (Figure 1). The needle allows for the passage of a guidewire, which travels from the true lumen, through the subintimal track passing the CTO, and then to the true lumen. The placement of this guidewire allows interventions to be performed. Three cases were subsequently selected and described in further detail in order to demonstrate the techniques employed during the use of the Pioneer catheter. Results Table 1 describes the demographics of the study population. There were a total of 21 cases of CTOs requiring utilization of the Pioneer catheter. The average age of the population was 74 years (standard deviation [SD] ± 14 years) with a range of 39–93. Most of the patients were female, and approximately 90% of the population had hypertension. All of the patients had complaints of claudication and only 1 patient had critical limb ischemia. Table 2 describes the procedural technique. The most commonly occluded vessels in our study population were the CIA and the superficial femoral artery (SFA). There was a fairly even distribution among the re-entry vessels, as well as the approach for each case being nearly even between ipsilateral and contralateral. The average occlusion length was 107 mm (SD ± 87) with a range of 23–300 mm. All successful cases received at least 1 stent after angioplasty. The average total length of stents used in each case was 183 mm (SD ± 104). The average amount of contrast needed for each case was 163 cc (SD ± 67.5). The average amount of fluoroscopy time needed for each case was 38.7 minutes (SD ± 17). The Pioneer catheter successfully opened CTOs when using either an antegrade or retrograde approach in relationship to the occlusion site. There was only 1 complication in the study population not related to the Pioneer catheter. A patient developed a dissection distal to the re-entry site with subsequent compromised distal blood flow. An additional stent was deployed that resolved the dissection and restored flow to normal. There was also only 1 procedural failure noted in the study population. An 88-year-old female with a CTO of the right SFA had undergone subintimal angioplasty without success. The patient had a contralateral approach with appropriate dissection into the subintimal space. The Pioneer catheter was subsequently inserted into the subintimal space and yet the true lumen of the popliteal artery could not be identified by IVUS. Several attempts to pass the needle into the true lumen were made, but were unsuccessful. Several cases were selected in order to discuss in greater detail the specific techniques used. Case 1. Right CIA occlusion with aortic re-entry. A 63-year-old African-American female with right-sided claudication symptoms presented for evaluation. Ankle brachial index measurements were 0.69 on the right and 0.95 on the left. She was referred for invasive angiography and possible intervention. She was found to have an 80 mm ostial right CIA occlusion with extensive collaterals to the right common external and internal iliac arteries. The right SFA had Case 2: Right SFA occlusion with popliteal reentry. A 78-year-old male with a history of coronary artery disease and bilateral lower extremity claudication (right greater than left) underwent percutaneous transluminal angioplasty and stent placement of the left SFA. At the time of this procedure, he was found to have a CTO of the right SFA and was brought back to the catheterization laboratory. A 30 mm occlusion of the distal right SFA was present with three-vessel runoff to the foot. Ipsilateral access of the right common femoral artery was obtained. A 0.035 inch angled Glidewire was positioned in the subintimal space in the proximal portion of the occlusion. The Glidewire was advanced until the tip of the wire was parallel to the reconstitution point of the distal right SFA. A 5 Fr Glidecath was advanced over this wire. The Glidewire was exchanged out for a 0.014 inch Hi-Torque guidewire, over which the Pioneer catheter was advanced. With IVUS guidance, the lumen of the reconstituted distal right SFA was localized and the lumen of the distal right SFA/popliteal artery was re-entered with the access needle. After the 0.014 inch Hi-Torque guidewire was advanced, it was exchanged out for the Glidecath, which confirmed intraluminal position in the popliteal artery with contrast injection. The re-entry site was dilated with a 2.5 x 20 mm Maverick balloon (Boston Scientific Corp., Natick, Massachusetts) and subsequently a 5 x 20 mm Powerflex balloon. A 6 x 100 mm Viabahn covered stent (W.L. Gore & Associates, Flagstaff, Arizona) was deployed such that the distal end of the stent was within the proximal popliteal artery and the proximal end was within the SFA. The stent was postdilated with a 6 x 40 mm Powerflex balloon. Final angiography (Figure 3) demonstrated 0% residual disease, with no evidence of perforation or dissection and good distal runoff. Case 3: Left SFA occlusion with SFA re-entry. The patient is a 93-year-old Asian female with a history of hypertension, hypercholesterolemia and known peripheral artery disease who had previously undergone intervention on her right SFA and anterior tibial arteries for claudication. She returned a month later for a staged procedure of the left SFA CTO. The left SFA was occluded at the ostium with evidence of dense calcification. The left popliteal artery had an 80% mid stenosis and reconstituted via the profunda femoralis collaterals. The left anterior tibial artery had tandem proximal to mid 80–90% stenosis with single-vessel runoff to the left foot. The ostial left SFA occlusion was crossed from a contralateral antegrade approach with a 0.035 inch Glidewire with eventual subintimal tracking. This wire was then exchanged out over a 5 Fr Glidecatheter for a 0.014inch Hi-Torque guidewire over which the Pioneer catheter was advanced into the extraluminal plane. With IVUS guidance, re-entry was made into the distal SFA. The track was predilated with a 3.5 mm Maverick balloon (Boston Scientific) followed by placement of sequential, overlapping 6 x 120 mm and 6 x 150 mm Protégé stents and a 5 x 40 mm Precise stent (Cordis). There was 10% residual disease in the SFA (Figure 4). Distal single-vessel runoff remained intact. Discussion In this study, we found a 95% procedural success rate for subintimal angioplasty with the use of a re-entry device. The cases selected illustrate the use of the Pioneer catheter for endovascular intervention of CIA and SFA CTOs. There was only 1 major complication —unrelated to the Pioneer catheter — that was treated with an additional stent. Prior to the advent of subintimal angioplasty, treatment of peripheral CTOs was primarily surgical. Five-year patency rates ranged from 63–75% after treating critical limb ischemia with open femoral-popliteal bypass using an autogenous vein graft,11–13 and surgery was considered an excellent treatment plan. Some investigators considered that if disease is severe enough, treatment should be limited to surgery instead of endovascular intervention.14 However, in certain cases, there is a trend toward inclusion of endovascular procedures as opposed to strictly surgical treatment of peripheral vascular disease. This is demonstrated by Kudo et al, who retrospectively reviewed one vascular surgeon’s trends in the treatment of critical limb ischemia over a 12-year period, and found that endovascular procedures were replacing open surgical procedures without compromising long-term results.15 Also, in the past, it had been general practice to treat TASC II Class A and B lesions via an endovascular approach and Class C and D lesions via an open surgical approach. However, Leville et al performed a study that showed Class C and D lesions can be safely treated via an endovascular approach.16 Although primary patency rates are higher for surgical bypass grafts, the shift to endovascular treatment of peripheral vascular disease continues due to lower costs, shorter hospital stays, lower morbidity and low complication rates. Even if repeat endovascular procedures are necessary to maintain patency, the outpatient nature of these procedures would allow improved quality of life compared to surgical intervention.17 Table 3 summarizes patency rates reported in the literature for patients having undergone successful subintimal angioplasty at follow up of either 6 or 12 months; they range from 70–77%. London et al had long-term follow up at 36 months and found a patency rate of 58%.2 These rates do not compare as favorably as those found for autogenous venous open bypass grafts, which range from 84–91% after 6 months and 78–87% after 12 months.11–13 However, given the minimally invasive nature of subintimal angioplasty, the risk-benefit ratio appears to be in favor of an endovascular approach. The role of the re-entry catheter is to increase the number of procedurally successful cases of CTOs treated with subintimal angioplasty. Rates of success without the use of a re-entry catheter are in the range of 74–87% (Table 3). This would suggest that almost 25% of all CTOs would not be treated by an endovascular approach. Table 4 describes the success rate of subintimal angioplasty with the use of the Pioneer catheter. Without the use of a true lumen re-entry device, Jacobs et al found a rate of 26% of failed re-entry for cases of CTO. Subsequently, the Pioneer catheter was utilized for 21 of the cases and they achieved a 100% success rate.7 In the current study, 21 cases required the Pioneer catheter and 20 cases had procedural success, for a rate of 95%. Saket et al employed the Pioneer catheter in 7 cases of CTO with success in all 7 cases.8 In addition, Casserly et al utilized the re-entry device successfully in several cases.6 The Pioneer catheter’s ability to improve the procedural success rates of subintimal angioplasty will decrease the number of patients requiring open surgery, which could lead to improved quality of life and lower costs. Limitations of the Pioneer catheter include its indication only for peripheral vasculature. The catheter is not indicated for use in the coronary or cerebral vasculature. Another limitation is the requirement of a specific IVUS system, the Volcano IVUS system (Volcano Corp., San Diego, California). Hospitals that are not equipped with this specific IVUS system would not be able to utilize the Pioneer catheter. An alternative re-entry device is the Outback catheter (Cordis), which also has an extendable curved needle for lumen re-entry, yet does not use IVUS guidance. The Outback catheter uses radiopaque markers on the catheter for orientation prior to needle deployment. This is an alternative for hospitals that do not have the Volcano IVUS system. The present report is one of the largest to detail the use of the Pioneer catheter to treat CTOs of the peripheral arteries. In addition to confirming that the Pioneer catheter can improve the success rate of subintimal angioplasty for CTOs, our study reports on the catheter’s versatility. The catheter was shown to be successful when used in an anterograde or retrograde fashion; it was successful when used from an ipsilateral or contralateral access site; it may be applied to all TASC II classifications; and re-entry is possible in most vessels ranging from the aorta to the popliteal arteries (Table 2). The cases presented here demonstrate the ease of implementing the Pioneer catheter with the standard practice of subintimal angioplasty, along with the accuracy and precision that ultrasound guidance provides. In conclusion, the Pioneer catheter is a safe and effective re-entry device that improves technical success of subintimal angioplasty, which may lead to improvement in the care of patients with CTOs. __________________________ From the *Heart Institute, †Department of Cardiology, Good Samaritan Hospital, Los Angeles, California; ‡Division of Cardiovascular Medicine, Keck School of Medicine, University of Southern California, Los Angeles; and the §Division of Cardiology, Harbor UCLA Medical Center, Torrance, California. The authors report no financial relationships or conflicts of interest regarding the content herein. Manuscript submitted March 27, 2009 and accepted May 18, 2009. Address for correspondence: David M. Shavelle, MD, FACC, Los Angeles BioMedical Research Institute, Division of Cardiology, Harbor UCLA Medical Center, 1000 W. Carson St., Torrance, CA 90509. E-mail: dshavelle@hotmail.com

1. Bolia A, Miles KA, Brennan J, Bell PR. Percutaneous transluminal angioplasty of occlusions of the femoral and popliteal arteries by subintimal dissection. Cardiovasc Intervent Radiol 1990;13:357–363.

2. London NJM, Srinivasan R, Naylor AR, et al. Subintimal angioplasty of femoropopliteal artery occlusions: The long-term results. Eur J Vasc Surg 1994;8:148–155.

3. McCarthy RJ, Neary W, Roobottom C, et al. Short-term results of femoropopliteal subintimal angioplasty. Brit J Surg 2000;87:1361–1365.

4. Lipsitz EC, Ohki T, Veith FJ, et al. Does subintimal angioplasty have a role in the treatment of severe lower extremity ischemia? J Vasc Surg 2003;37:386–391.

5. Tartari S, Zattoni L, Rolma G, Sacco A. Subintimal angioplasty of infrapopliteal artery occlusions in the treatment of critical limb ischaemia. Short-term results. Radiol Med 2004;108:265–274.

6. Casserly IP, Sachar R, Bajzer C, Yadav JS. Utility of IVUS-guided transaccess catheter in the treatment of long chronic total occlusion of the superficial femoral artery. Catheter Cardiovasc Interv 2004;62:237–243.

7. Jacobs DL, Motaganahalli RL, Cox DE, et al. True lumen re-entry devices facilitate subintimal angioplasty and stenting of total chronic occlusions: Initial report. J Vasc Surg 2006;43:1291–1296.

8. Saket RR, Razavi MK, Padidar A, et al. Novel intravascular ultrasound-guided method to create transintimal arterial communications: Initial experience in peripheral occlusive disease and aortic dissection. J Endovasc Ther 2004;11:274–280.

9. Hausegger KA, Georgieva B, Portugaller H, et al. The Outback catheter: A new device for true lumen re-entry after dissection during recanalization of arterial occlusions. Cardiovasc Intervent Radiol 2004;27:26–30.

10. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). Eur J Vasc Endovasc Surg 2007;33:S1–S70.

11. Taylor LM, Edwards JM, Porter JM. Present status of reversed vein bypass grafting: Five-year results of a modern series. J Vasc Surg 1990;11:193–206.

12. Bergamini TM, Towne JB, Bandyk DF, et al. Experience with in situ saphenous vein bypasses during 1981 to 1989: Determinant factors of long-term patency. J Vasc Surg 1991;13:137–149.

13. Donaldson MC, Mannick JA, Whittemore AD. Femoral-distal bypass with in situ greater saphenous vein: Long-term results using the Mills valvulotome. Ann Surg 1991;213:457–464.

14. Hasanadka R, Brown KR, Rilling WS, et al. The extent of lower extremity occlusive disease predicts short- and long-term patency following endovascular infrainguinal arterial intervention. Am J Surg 2008;196:629–633.

15. Kudo T, Chandra FA, Kwun WH, et al. Changing pattern of surgical revascularization for critical limb ischemia over 12 years: Endovascular vs open bypass surgery. J Vasc Surg 2006;44:304–313.

16. Leville CD, Kashyap VS, Clair DG, et al. Endovascular management of iliac artery occlusions: Extending treatment to TransAtlantic Inter-Society Consensus class C and D patients. J Vasc Surg 2006;43:32–39.

17. Lee LK, Kent KC. Infrainguinal occlusive disease: Endovascular intervention is the first line therapy. Adv Surg 2008;42:193–204.