Original Contribution

Systematic Review of the BridgePoint System for Crossing Coronary and Peripheral Chronic Total Occlusions

Jedrek Wosik, MD1;  Deborah Shorrock1;  Georgios Christopoulos, MD1;  Anna Kotsia, MD, PhD1;  Bavana V. Rangan, BDS, MPH1;  Michele Roesle, RN1;  Spyros Maragkoydakis, MD2;  Shuaib M. Abdullah, MD1;  Subhash Banerjee, MD1;  Emmanouil S. Brilakis, MD, PhD1

Jedrek Wosik, MD1;  Deborah Shorrock1;  Georgios Christopoulos, MD1;  Anna Kotsia, MD, PhD1;  Bavana V. Rangan, BDS, MPH1;  Michele Roesle, RN1;  Spyros Maragkoydakis, MD2;  Shuaib M. Abdullah, MD1;  Subhash Banerjee, MD1;  Emmanouil S. Brilakis, MD, PhD1

Abstract: Background. The BridgePoint system consists of the CrossBoss coronary catheter and Stingray CTO system (Boston Scientific) for coronary chronic total occlusions (CTOs), and the Viance crossing catheter and Enteer re-entry system (Covidien) for peripheral CTOs. Methods. We performed a systematic review of the literature on the BridgePoint system published between October 2008 and August 2014, in accordance with the standards set forth in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Results. We identified a total of 20 studies: 12 studies on coronary CTOs (10 retrospective with 2 prospective case series) and 8 studies on peripheral CTOs (all retrospective). Among 320 patients undergoing coronary CTO intervention, pooled technical success and major adverse cardiac event rates were 77.1% and 3.8%, respectively. Among 175 patients undergoing peripheral CTO intervention, pooled technical success and major adverse events were 82.2% and 4.6%, respectively. Only 1 study reported long-term outcomes after use of the coronary BridgePoint system, demonstrating similar incidence of major adverse cardiac events between BridgePoint-treated and non-BridgePoint treated patients; however, the study had low power. Conclusions. The BridgePoint system is associated with high procedural success rates and low complication rates when used for crossing both coronary and peripheral CTOs.

J INVASIVE CARDIOL 2015;27(6):269-276

Key words: percutaneous coronary intervention, chronic total occlusion, cardiac catheterization, percutaneous peripheral CTO intervention 

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Chronic total occlusions1 are commonly encountered in both the coronary2-5 and peripheral6 arterial circulation and are often challenging to treat, mainly due to difficulties crossing the lesion with a guidewire.7,8 The BridgePoint system was designed to facilitate CTO crossing and consists of the CrossBoss coronary catheter and Stingray CTO system re-entry balloon and guidewire (Boston Scientific) for coronary CTOs, and the Viance crossing catheter and Enteer re-entry system (Covidien) for peripheral CTOs.

Apart from traditional antegrade wire escalation techniques, antegrade dissection/re-entry9 and the retrograde approach10 have revolutionized the field of CTO percutaneous coronary intervention (PCI) by increasing procedural success rates. Extensive antegrade dissection/re-entry has been associated with high restenosis and reocclusion rates in CTO-PCI, and is only recommended as a last resort.11 Limited antegrade dissection/re-entry is preferred and recommended for lesions ≥20 mm in length,12 as it is a safe and efficient crossing technique that reduces stent length, and provides more predictable and reliable procedural results. Limited dissection and re-entry can be achieved either using guidewires (in the mini subintimal tracking and re-entry [mini-STAR] technique13 and the limited antegrade subintimal tracking [LAST] technique8), or using the BridgePoint coronary system (Figure 1). 

Peripheral CTOs are often crossed subintimally, yet re-entry into the distal true lumen can be challenging. Similar to coronary CTOs, use of the peripheral Viance crossing catheter and Enteer re-entry system (Figure 2) can facilitate peripheral CTO crossing and re-entry.14 Herein, we review the coronary and peripheral BridgePoint devices and summarize the published literature on their use. 

Methods

Literature review. Literature review was performed in accordance with the standards set forth in the PRISMA statement (Figure 3)15,16 using PubMed, EMBASE, Cochrane Library, and internet search engines (Google, Bing) from October 2008 to August 2014. Bibliographies of the retrieved studies were further searched manually for other relevant studies. No language restriction was placed. The searched terms and medical subject headings (MeSH) for coronary CTOs were “BridgePoint system,” “Stingray balloon,” “CrossBoss catheter,” “re-entry device and chronic total occlusion,” and “chronic total occlusion, antegrade and subintimal.” Terms used for the peripheral artery occlusion device search were “Viance,” “Enteer,” and “subintimal chronic total occlusion.” Articles were included if patients were treated with any component of the BridgePoint system, including use of the coronary system in peripheral cases. All published studies, including case reports on coronary or peripheral CTOs, were included. Letters to the editor and studies in which outcomes after use of the BridgePoint system could not be accurately assessed from the published manuscript were excluded. Data from conferences and press releases were included.17 Quality was assessed according to criteria based on National Health Service Centre for Reviews and Dissemination guidance.18 Chronic total occlusions were defined throughout the studies as either occluded coronary arteries exhibiting Thrombolysis in Myocardial Infarction (TIMI) flow grade 0 to 1, or as 100% lower-extremity arterial occlusions, both with estimated duration of at least 3 months. Major adverse cardiac event (MACE) rate was defined as the composite of death, emergency coronary artery bypass graft (CABG) surgery, and myocardial infarction (MI).

Device Descriptions

CrossBoss crossing catheter. The CrossBoss catheter (Figure 1A) is a stiff, metallic, over-the-wire catheter with a 1 mm, blunt, rounded, hydrophilic-coated distal tip that is steered to the occlusion site and advanced using a proximal torque device (“fast-spin” technique) past the occluded lesion. The working length of the coronary catheter is 135 cm. In approximately 1 in 3 cases, the CrossBoss catheter crosses into the distal true lumen.1 When it crosses into the subintimal space, it creates a limited dissection plane, facilitating re-entry. Use of the CrossBoss catheter carries low risk of perforation, provided that entry into side branches is avoided. If the CrossBoss catheter crosses into the subintimal space, various techniques can be used for re-entry into the true lumen, such as the Stingray balloon and guidewire, the STAR and mini-STAR technique, and the LAST technique.19-21

Stingray CTO system (balloon and guidewire). The Stingray balloon is 10 mm in length and 2.5 mm wide when inflated, and has a flat shape with two side-exit ports (Figure 1B). Upon low-pressure (2-4 atm) inflation, one exit port is automatically oriented toward the true lumen and the other one toward the vessel adventitia.9 The delivery catheter shaft is 0.35 mm in diameter and it is 0.014˝ guidewire compatible. The Stingray guidewire is a stiff guidewire with a 20 cm distal radiopaque segment, a 1.5 mm, 28º angle, distal bend, and a tapered tip with a 0.0035˝ distal prong. The working length for the coronary system is 135 cm. The Stingray guidewire (available in 300 cm and 185 cm lengths) is advanced through one of the two side ports of the Stingray balloon under fluoroscopic guidance to re-enter into the distal true lumen.19-21 

Viance crossing catheter. The Viance catheter is similar to the CrossBoss catheter, but with a firmer shaft for greater pushability and torque control. The catheter has a 150 cm working length with a 0.97 mm crossing profile, 0.44 mm internal diameter, and 0.94 mm tip. It is compatible with ≥5 Fr support catheters and 0.014˝ guidewires. Flexible and standard-stiffness shaft configurations are available.22 Before the Viance catheter became available, the CrossBoss system was often used in peripheral CTOs.14,23-26 The Viance catheter is best utilized through a support catheter that increases the penetrating power of the device and reduces bending of the catheter shaft. Directional control of the device while tackling peripheral artery CTO with side branches can be achieved by using an appropriately shaped guidewire. 

Enteer re-entry system (balloon and guidewire). The Enteer balloon and guidewire are similar to the Stingray balloon and guidewire, but were modified to make them more suitable for peripheral cases. For above-the-knee CTOs, the working device length is 135 cm and balloon dimensions (width x height x length) are 3.75 x 1.5 x 20 mm. For below-the-knee lesions, the working length is 150 cm with smaller balloon dimensions (2.75 x 1.0 x 20 mm). The system is compatible with 5 Fr sheaths. Three different guidewires are available: flexible, standard, and stiff tip, with a tip reach of 1.5 mm, 1.5 mm, and 2.5 mm, respectively. All wires are 300 cm in length, hydrophilic, and 0.014˝ in diameter.27 

Results

Studies. The literature search is outlined in Figure 3. We identified a total of 24 studies: 16 on coronary CTOs (11 case series reporting acute procedural results, 1 series reporting follow-up outcomes, 2 reports of using the system for bail-out after a complication occurred, and 2 commentaries/reviews; Table 1);1,9,19-21,28-38 and 8 on peripheral CTOs (Table 2).14,17,23-26,39,40 A total of 320 patients with 327 coronary CTOs and 175 patients with 185 peripheral CTOs were included. The 2 reports demonstrating use of the system for bail-out28,30 and the 2 review articles9,19 were not included in the final analyses. 

Coronary studies. A total of 12 studies with 320 patients undergoing 327 PCIs were identified (Table 1).1,20,21,29,31-38 The CrossBoss catheter was the sole device used in 173 cases (52.9%), both the CrossBoss catheter and the Stingray system were used in 102 cases (31.2%), and the Stingray system alone was used in 50 cases (15.3%). The Stingray guidewire alone was used in 2 cases (0.6%).

The 12 studies provided acute procedural results on 320 patients, with 1 study providing long-term results on 60 patients.31 The largest study was the FAST-CTO (Facilitated Antegrade Steering Technique in Chronic Total Occlusions) trial that led to United States Food and Drug Administration approval for the device.1 This prospective, multicenter, single-arm study demonstrated that the use of CrossBoss and Stingray devices resulted in high success rates (77%) among 147 patients undergoing PCI of a refractory or previously failed CTO. Fluoroscopy time was shorter, and the 30-day MACE rate was similar with historical controls. The CrossBoss catheter alone successfully crossed into the distal true lumen in 37% of cases.

Among all published studies (Table 1), pooled technical success and MACE rates were 77.1% and 3.8%, respectively. Perforation and MI occurred in 4.9% and 4.9% of patients, respectively. The pooled rate of death and emergent CABG was 0.6% and 0%, respectively. Most studies only reported immediate procedural outcomes, with only 4 studies reporting outcomes during a follow-up of 30 days.1,31,35,36 

In the pivotal FAST-CTO clinical trial, a perforation rate of 9.3% was reported;1 however, no patient developed tamponade. Coronary perforation occurred in <2% of recent studies.31 Most perforations were grade I or II, and were rarely associated with MACE. 

Treatment of in-stent restenosis (ISR) using the CrossBoss catheter was presented in 5 coronary studies.31-33,35,37 Forty-two patients with a total of 44 coronary ISR-CTOs were treated. The pooled technical success rate was 88.6%.

Occlusive coronary dissections that cannot be crossed with a guidewire may require emergent CABG, which carries high morbidity and mortality.41 The Stingray system has been successfully used as bail-out for occlusive dissections complicating elective30 or primary28 PCI.

Only 1 single-center study has described long-term follow-up outcomes after use of the BridgePoint system.31 Among 170 consecutive patients who underwent successful CTO-PCI, 60 were treated with the BridgePoint system, while 110 were treated with other CTO crossing techniques and devices. Although CTO complexity was higher in the BridgePoint group, during a median follow-up of 1.81 years, the incidences of target lesion revascularization (TLR; 40.9% vs 29.6%; P=.13) and overall MACE (40.3% vs 35.2%; P=.42) were similar in the BridgePoint and the non-BridgePoint groups. However, the study had low power to detect differences between groups due to its relatively small sample size. 

Peripheral studies. A total of 8 studies including 175 patients who underwent 185 peripheral CTO interventions using the BridgePoint system were retrieved (Table 2).14,17,23-26,39,40 Most lesions were located in the superficial femoral artery (n = 99; 53.5%), followed by the tibial artery (n = 50; 27.0%), the popliteal artery (n = 24; 13.0%), the peroneal artery (n = 9; 4.9%), the common femoral artery (n = 2; 1.1%), and the tibioperoneal trunk (n = 1; 0.5%). Mean lesion length ranged from 81-195 mm. Pooled success rate was 82.2%, and pooled major adverse event (MAE; defined as all-cause death, unplanned major amputation or surgery, perforation requiring intervention, or large access-site hematoma) rate was 4.6%. Perforation occurred in 0.6% (n = 1), target vessel revascularization in 2.3% (n = 4), and hematoma in 1.7% (n = 3). Three studies with 139 patients had 30-day follow-up, with a pooled MAE rate of 5.7% (n = 8), including 2.1% frequency of hematomas (n = 3), 2.8% TLR rate (n = 4), and 0.7% perforation (n = 1). Of note, 13 out of 15 lesions in which long-term patency was assessed remained patent at 1 year.26 All peripheral studies except 317,39,40 used the coronary BridgePoint system, as the Viance/Enteer system was introduced later into clinical practice. 

Two studies reported treatment of peripheral ISR using the CrossBoss catheter.14,26 A total of 4 patients with 4 ISRs were treated, all successfully. 

Discussion 

Our review demonstrates that the BridgePoint system can be used in both coronary and peripheral CTOs, with high success and low complication rates. 

Coronary CTOs. The 1 mm blunt tip of the CrossBoss catheter, combined with its torquability using the fast-spin technique, allows efficient crossing through occlusions, with true-to-true lumen crossing achieved in approximately one-third of cases.1,31,42,43 The advantage of the CrossBoss catheter compared with a knuckle wire is that it limits the size of the dissection and the likelihood of false lumen hematoma formation, which can hinder wire re-entry by compressing the distal true lumen. That is why use of the CrossBoss catheter is recommended even when a knuckle wire is used for CTO crossing to minimize the size of hematoma at the re-entry zone (“finish with the Boss”).8

To minimize the risk of perforation, the CrossBoss catheter should not be used if the proximal cap is ambiguous.26 Moreover, the CrossBoss catheter torque device should be connected 3-4 cm from the hemostatic valve to limit the length of forward movement of the device, which can be sudden. Effective use of the CrossBoss catheter requires excellent guide catheter support, and it may have limited penetration capacity in old and densely calcified occlusions;26 in such cases, starting a dissection plane by inflating a slightly oversized balloon (balloon-assisted subintimal entry [BASE]) or by advancing a stiff tapered-tip guidewire (the “scratch and go” technique) can assist with initiating crossing with the CrossBoss catheter. Use of the CrossBoss catheter can help achieve safe and rapid crossing of long occlusions, taking advantage of the distensibility of the subintimal space.

CTO due to in-stent restenosis. Treatment of occlusive ISR represents 5%-25% of CTO-PCI and can be highly challenging with traditionally low procedural success rates6,44 due to multiple reasons, such as wire entry into side branches, lesion tortuosity, relative absence of microchannels, and stent abnormalities (such as under-deployment, fracture, or deformation).31,33,37 The CrossBoss and Viance catheters are particularly appealing for crossing ISR-CTOs because the occluded stent may prevent the catheter from entering the subintimal space, although sub-stent crossing is still possible.32 The CrossBoss catheter was often successful in crossing into the distal true lumen or achieving partial crossing followed by distal true lumen entry with a stiff, tapered guidewire.33 In our review, the CrossBoss catheter successfully crossed 88.6% of coronary ISR-CTOs in 41 patients and 100% of peripheral ISR-CTOs in 4 patients. 

Peripheral CTOs. Similar to coronary CTOs, high success rates were achieved with use of the BridgePoint system in peripheral CTOs, which is facilitated by the straight vessel course and the ability to use the system through a delivery catheter, further increasing the CTO penetrating capacity. The use of a wire alone coupled with a support catheter has been shown to cross infrainguinal CTOs in only 40%-60% of cases.45

The Viance and Enteer catheters have higher stiffness and reach, respectively, compared to the CrossBoss and Stingray catheters; however, the CrossBoss catheter continues to be very useful for below-the-knee interventions, since these vessels have diameters similar to the coronary arteries.26 Severe calcification can hinder crossing with the Viance catheter; in such cases, the True Path catheter (Boston Scientific)46 or the Crosser catheter (Bard)47 may be useful.

Long-term outcomes. There are limited long-term outcome data after use of the BridgePoint devices. The only study with long-term follow-up examined 60 patients who underwent treatment using the CrossBoss and/or Stingray catheter, demonstrating outcomes similar to CTOs treated with other crossing techniques during a median follow-up of 1.81 years.31

Study limitations. Our study has important limitations. There is no randomized controlled trial to date comparing the BridgePoint system with other devices or techniques; however, the FAST-CTOs trial only included lesions that could not be recanalized using other CTO-PCI techniques. Many studies only reported procedural outcomes in a small number of patients, with only 4 studies including >40 patients (range, 42-147 patients).35,36 In addition, most studies did not adjudicate outcomes by a clinical events committee and did not perform dedicated angiographic core laboratory analysis. Use of the BridgePoint devices (as any other CTO crossing device) should be performed by operators with experience and expertise in treating these complex lesion subgroups, since various techniques used in combination may be required for a successful outcome12 and there is a steep learning curve.48,49 Large studies with long-term follow-up are needed to define the long-term outcomes with use of the CrossBoss/Stingray and Viance/Enteer systems, especially in challenging lesion subgroups (such as ISR, calcified vessels, as a first-line strategy, etc). Several ongoing registries, such as the PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) (NCT02061436), the RECHARGE (CrossBoss and Hybrid Registry on Coronary Chronic Total Occlusions) (NCT02075372), the CONSISTENT-CTO, and the OPEN-CTO (OPEN Chronic Total Occlusion) (NCT02026466) registry will provide additional information on the outcomes with use of the BridgePoint system in the future.

Conclusion

The BridgePoint coronary and peripheral CTO systems can significantly increase CTO intervention procedural success rates with low risk of complications. Long-term studies are needed to examine the durability of the procedural results. 

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From 1VA North Texas Healthcare System and UT Southwestern Medical Center, Dallas, Texas; and 2University Hospital of Heraklion, Heraklion, Greece.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Banerjee reports institutional research grants from BridgePoint, Gilead, and the Medicines Company; consultant/speaker honoraria from Covidien and Medtronic; ownership in MDCare Global (spouse); intellectual property in HygeiaTel. Dr Brilakis reports personal fees from Abbott Vascular, Asahi Intecc, Boston Scientific, Elsevier, Somahlution, St. Jude, Terumo; grants from Guerbet, InfraRedx; spouse is an employee of Medtronic. The remaining authors report no disclosures regarding the content herein.

Manuscript submitted July 24, 2014, provisional acceptance given August 11, 2014, final version accepted September 12, 2014.

Address for correspondence: Emmanouil S. Brilakis, MD, PhD, Dallas VA Medical Center (111A), 4500 South Lancaster Road, Dallas, TX 75216. Email: esbrilakis@gmail.com

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