Subintimal Tracking and Re-entry Technique for Stent-Jailed Side-Branch Occlusion

Abstract

Objectives. This study aimed to evaluate the clinical effectiveness and outcomes of treatment with the subintimal tracking and re-entry technique for stent-jailed side branch (SB-STAR). SB occlusion is a serious complication of percutaneous coronary intervention (PCI). However, conventional strategies may fail to recanalize the stent-jailed SB. Methods. We retrospectively analyzed consecutive patients who underwent elective PCI and were treated with SB-STAR at the Sapporo Cardiovascular Clinic in Japan. SB was treated for severe stenosis, reduced thrombolysis in myocardial infarction flow grade, or ischemic signs after main vessel stenting. Technical success during the procedure and clinical and angiographic follow-up findings at 6 months were analyzed. Results. Of the 13,431 PCI procedures performed between January 2016 and June 2021, SB-STAR was performed in 10 patients. The angiographic success rate was 100%. At the 6-month follow-up, no deaths or target-vessel revascularizations had occurred. All patients underwent angiographic follow-up, and 8 of the 10 patients (80%) who underwent SB-STAR had confirmed patency. Conclusions. SB-STAR can be a bailout strategy to improve the critical situation of stent-jailed SB occlusion. At 6-month follow-up, the SB-STAR had good patency as well as good clinical outcomes.

J INVASIVE CARDIOL 2022;34(9):E678-E682. Epub 2022 August 12.

Key words: bifurcation, complications, coronary artery disease, percutaneous coronary intervention

Side-branch (SB) occlusion is a major complication of percutaneous coronary intervention (PCI) and occurs in 7.3%-19% of bifurcation lesions.^1-4 Once the SB is occluded, the patient might not only complain of ischemic symptoms but also experience myocardial injury, resulting in worse clinical outcomes. In cases of SB occlusion, ballooning or stenting is required after crossing the guidewire. However, guidewire crossing after SB occlusion can be challenging. In particular, crossing the guidewire for occluded SB after main vessel (MV) stenting is more difficult, as the guidewire might unexpectedly enter the subintimal space.

The subintimal tracking and re-entry (STAR) technique is used as a bailout strategy for chronic total occlusion (CTO) revascularization. However, the effectiveness of the STAR technique for stent-jailed SB (SB-STAR) is unknown.

This study aimed to evaluate the clinical effectiveness and outcomes of treatment with SB-STAR. We investigated whether SB-STAR could be used as a rescue technique for stent-jailed SB occlusions. To our knowledge, this is the first study that treated acute SB occlusion after MV stenting with STAR.

Methods

Patient population. This study retrospectively analyzed the data of consecutive patients from our institutional database who underwent elective PCI and were treated with SB-STAR at the Sapporo Cardiovascular Clinic from January 2016 to June 2021. This study was conducted in accordance with the principles of the Declaration of Helsinki. The ethics committee of our institution approved the study and patients provided informed consent. All patients underwent PCI because they were either symptomatic or had ischemia documented by a fractional flow reserve of ≤0.80.⁵ We excluded patients with STAR for CTO, non-stent-jailed SB, iatrogenic dissection in MV, and missing clinical or angiographic follow-up data.

Stent-jailed SB and SB-STAR procedure. A stent-jailed SB was defined as any decrease in Thrombolysis in Myocardial Infarction (TIMI) flow grade or absence of SB flow after stenting, with or without preballooning of the MV. The SB is usually not treated unless severe stenosis (>90%), TIMI flow grade decrease or occlusion, SB dissection, or ischemic signs (such as chest pain or ST elevation) occur. If any of these criteria are present, the SB is rewired, and balloon dilation or stenting is performed. In our study, all PCI procedures for MV used a second-generation drug-eluting stent.

When the SB was impaired, we first attempted to recross the SB with conventional strategies, such as using a floppy guidewire with a dual-lumen catheter (Figures 1A, 1B). If failure occurred, we used a polymer-jacketed guidewire, such as the Sion Black (Asahi Intecc) or XT-R (Asahi Intecc) with a dual-lumen catheter. If that did not work either, and if the guidewire advanced into the subintimal space, SB-STAR was performed as a bailout strategy (Figure 1C). SB-STAR was performed using a floppy or polymer-jacketed guidewire with a microcatheter (Figure 1D). The type of guidewire used was at the discretion of the operator. A typical case using the SB-STAR is shown in Figure 2.

Procedural and clinical outcomes. Patients underwent computed tomography (CT) or coronary angiography (CAG) at 6 months. Patency was defined as TIMI grade⁶ of 2-3 flow in the SB on CAG or confirmed blood flow on CT. Major adverse cardiac events (MACEs) were defined as all-cause death, myocardial infarction (MI), and target-vessel revascularization (TVR). Myocardial infarction was defined as the elevation of creatine kinase (CK) levels by ≥3 times or new Q waves in ≥2 more contiguous leads on the electrocardiogram. The total CK level was measured in all patients between 12 and 24 hours after PCI. Blood samples were evaluated before and on the day of PCI. Target-vessel revascularization was defined as any revascularization procedure involving the MV and SB. Echocardiography was performed before the initial PCI and at the 6-month follow-up exam. Left ventricular ejection fraction (LVEF) was measured using the biplane Simpson’s method of discs.⁷ Left ventricular asynergy was documented by echocardiography. A decrease in LVEF was defined as a decrease of ≥10% compared with that before PCI.⁸

The primary endpoint was the technical success at the time of the procedure. The secondary endpoints were procedure-related complications, including death, coronary perforation or tamponade, MI, and TVR. Additional secondary endpoints included MACEs and SB patency documented by CAG or CT 6 months after PCI.

Results

Of the 13,431 PCI procedures performed during the study period, STAR was performed in 84 patients (CTOs, 44 patients; non-stent-jailed occlusions, 13 patients; iatrogenic dissection, 16 patients; and SB-STAR, 11 patients). One patient had missing follow-up data; therefore, the final analysis included 10 patients (Figure 3). The patient and procedural characteristics are summarized in Table 1. The mean patient age was 68.1 ± 2.9 years, and 40% were men. The left anterior descending (LAD) artery was the most common target vessel (n = 9; 90%) followed by the left circumflex (LCX) artery (n = 1; 10%).

The initial procedural success rate was 100% (n = 10). Procedure-related MI occurred in 4 patients (40%). No in-hospital deaths, clinical tamponade, or urgent TVR occurred. At the 6-month follow-up, the MACE-free survival rate was 100% and there were no deaths or TVR. CAG or CT was performed in all patients. Five patients underwent follow-up CAG and 5 patients underwent CT only. Of the 10 patients, only 8 (80%) had confirmed patency. Of the 2 patients whose patency could not be confirmed, 1 was in the LCX, and the other was in the LAD. None of the patients presented with new asynergy or a decrease in LVEF of ≥10% at the 6-month follow-up.

Discussion

We evaluated the effectiveness of the STAR technique for stent-jailed SB occlusions. The main findings were as follows: (1) SB-STAR is a viable technique in cases of failure of conventional guidewire crossing; (2) SB-STAR confers good patency (at the 6-month follow-up) as well as good clinical outcomes.

SB occlusion is an occasional but serious complication during PCI. Patients with SB occlusion had worse clinical outcomes than those without. In the SPIRIT III trial, SB occlusion was independently associated with higher rates of in-hospital and 3-year MACE.⁹ In the COBIS II registry, SB occlusion increased stent thrombosis (hazard ratio, 6.19) and cardiac death (hazard ratio, 4.19) at the 12-month follow-up. Furthermore, clinical outcomes were better in patients with recovered SB occlusion than in patients who had persistent occlusion.²

Several techniques have been reported to avoid SB occlusion, such as jailed wire,¹⁰ jailed balloon,¹¹ and jailed Corsair microcatheter (Asahi Intecc);¹² however, they do not completely avoid SB occlusion. Furthermore, these techniques may result in stent deformation or require surgical removal due to device entrapment.^13,14 When the SB is impaired, further procedures such as rewiring, balloon dilation, and stenting are required. However, rewiring sometimes fails because of wire entry into the subintimal space and the procedure may be terminated unintentionally with loss of the SB. Plaque shifts, carina shifts, dissection, presence of stent struts, and changes in the bifurcation angle, all of which can result in SB occlusion, can make rewiring of the SB difficult. Previous studies have reported that permanent loss of SB occurs in 1%-8% of the cases despite attempts at restoration.^15,16 In such critical situations, SB-STAR would be helpful.

The STAR technique is used primarily for CTO revascularization and it is mostly used as a bailout strategy. The reasons for this are a higher restenosis rate and the loss of SB. Colombo et al performed 31 CTO cases using the STAR technique as a bailout strategy.¹⁷ They reported a procedural success rate of 97%, while the restenosis rate was very high at 57%, with a mean follow-up of 5.1 ± 3.7 months. The SB-STAR technique had a high patency rate of 80% at 6 months. The finding that SB-STAR was performed on non-CTO-SBs may have led to the high level of patency. Colombo et al demonstrated the effectiveness of STAR for iatrogenic occlusive coronary dissection.¹⁸ Among the 9 patients with angiographic follow-up, the restenosis rate was 11% at a mean of 186 ± 79 days, similar to our results. STAR for non-CTOs may yield better results. However, further research is needed to determine whether the type of SB lesions, such as the presence of plaque, plaque morphology, or lesion length, is associated with a lower restenosis rate. ­Procedure-related MI occurred in 4 patients (40%) in this study; 3 patients who ended up with TIMI 2 in the SB after SB-STAR had CK level elevation, and all 3 patients had TIMI 0-1 in the SB before SB-STAR. Therefore, SB-STAR should have reduced the extent of infarction that had occurred. The other patient had elevated CK level despite ending at TIMI 3 for both MV and SB, likely due to the occluded major septal branch, independent of SB-STAR. However, in all patients with elevated CK levels, there was no reduction in ejection fraction at the 6-month follow-up, which did not lead to worsening of MACE rate. It is reasonable to consider the SB-STAR technique as a bailout strategy for patients with impaired SB, such as TIMI 0-1.

Study limitations. This study had several limitations. First, it was a single-arm, retrospective, observational study with a relatively small sample size, which may have led to selection bias. Second, most SBs treated with SB-STAR had a diagonal branch. Therefore, the effectiveness of SB-STAR for other SBs remains unknown. Finally, since CK-MB and troponin levels were not measured, procedure-related MI was assessed using total CK levels. Total CK levels could also be elevated by noncardiac factors, which could have led to an overestimation of procedure-related MI.

Conclusion

SB-STAR can be an effective strategy for resolving critical situations of SB occlusion following stenting. The use of this technique allows re-entry into the true lumen in most cases, even with wire entry into the subintimal space. Furthermore, SB-STAR had good patency as well as good clinical outcomes at 6-month follow-up.

Affiliations and Disclosures

From ¹Cardiovascular Medicine, Sapporo Heart Center, Sapporo Cardio Vascular Clinic, Sappora, Japan; and the ²Division of Cardiology, Shimane University Faculty of Medicine, Japan.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.

The authors report that patient consent was provided for publication of the images used herein.

Manuscript accepted March 17, 2022.

Address for correspondence: Yusuke Morita, MD, PhD, Cardiovascular Medicine, Sapporo Heart Center, Sapporo Cardio Vascular Clinic, 8-1, Kita-49 Higashi-16, Higashiku, Sapporo, Japan 007-0849. Email: morita-y@med.shimane-u.ac.jp

1. Dou K, Zhang D, Xu B, et al. An angiographic tool for risk prediction of side branch occlusion in coronary bifurcation intervention: the RESOLVE score system (risk prediction of side branch occlusion in coronary bifurcation intervention). JACC Cardiovasc Interv. 2015;8(1 Pt A):39-46. doi:10.1016/j.jcin.2014.08.011

2. Hahn JY, Chun WJ, Kim JH, et al. Predictors and outcomes of side branch occlusion after main vessel stenting in coronary bifurcation lesions: results from the COBIS II registry (coronary bifurcation stenting). J Am Coll Cardiol. 2013;62(18):1654-1659. Epub 2013 Aug 14. doi:10.1016/j.jacc.2013.07.041

3. Aliabadi D, Tilli FV, Bowers TR, et al. Incidence and angiographic predictors of side branch occlusion following high-pressure intracoronary stenting. Am J Cardiol. 1997;80(8):994-997. doi:10.1016/s0002-9149(97)00591-2

4. Zhang D, Xu B, Yin D, et al. How bifurcation angle impacts the fate of side branch after main vessel stenting: a retrospective analysis of 1,200 consecutive bifurcation lesions in a single center. Catheter Cardiovasc Interv. 2015;85(Suppl 1):706-715. Epub 2015 Feb 25. doi:10.1002/ccd.25858

5. Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009;360(3):213-224. doi:10.1056/NEJMoa0807611

6. Ganz W. The thrombolysis in myocardial infarction (TIMI) ­trial. N Engl J Med. 1985;313(16):1018. doi:10.1056/NEJM198510173131611

7. Klaeboe LG, Edvardsen T. Echocardiographic assessment of left ventricular systolic function. J Echocardiogr 2019;17(1):10-16. Epub 2018 Nov 2. doi:10.1007/s12574-018-0405-5

8. Chew DS, Heikki H, Schmidt G, et al. Change in left ventricular ejection fraction following first myocardial infarction and outcome. JACC Clin Electrophysiol. 2018;4(5):672-682. Epub 2018 Mar 1. doi:10.1016/j.jacep.2017.12.015

9. Lansky AJ, Yaqub M, Hermiller JB, et al. Side branch occlusion with everolimus-eluting and paclitaxel-eluting stents: three-year results from the SPIRIT III randomised trial. EuroIntervention. 2010;6(Suppl J):J44-J52. doi:10.4244/EIJV6SUPJA8

10. Lefèvre T, Louvard Y, Morice MC, et al. Stenting of bifurcation lesions: classification, treatments, and results. Catheter Cardiovasc Interv. 2000;49(3):274-283. doi:10.1002/(sici)1522-726x(200003)49:3<274::aid-ccd11>3.0.co;2-n

12. Burzotta F, Trani C, Sianos G. Jailed balloon protection: a new technique to avoid acute side-branch occlusion during provisional stenting of bifurcated lesions. Bench test report and first clinical experience. EuroIntervention. 2010;5(7):809-813. doi:10.4244/eijv5i7a135

13. Numasawa Y, Sakakura K, Yamamoto K, et al. A novel side branch protection technique in coronary stent implantation: jailed Corsair technique. Cardiovasc Revasc Med. 2017;18(4):295-298. Epub 2017 Jan 17. doi:10.1016/j.carrev.2017.01.009

14. Numasawa Y, Hitomi Y, Imaeda S, et al. Stent deformation caused by entrapment of the side branch balloon catheter during the jailed balloon protection technique for a calcified coronary bifurcation lesion: a case report and literature review. Cardiovasc Revasc Med. 2019;20(11):1023-1026. Epub 2018 Nov 22. doi:10.1016/j.carrev.2018.11.003

15. Karabulut A, Daglar E, Cakmak M. Entrapment of hydrophilic coated coronary guidewire tips: which form of management is best? Cardiol J. 2010;17(1):104-108.

16. Singh J, Patel Y, Depta JP, et al. A modified provisional stenting approach to coronary bifurcation lesions: clinical application of the “jailed-balloon technique”. J Interv Cardiol. 2012;25(3):289-296. Epub 2012 Feb 26. doi:10.1111/j.1540-8183.2011.00716.x

17. Depta JP, Patel Y, Patel JS, et al. Long-term clinical outcomes with the use of a modified provisional jailed-balloon stenting technique for the treatment of nonleft main coronary bifurcation lesions. Catheter Cardiovasc Interv. 2013;82(5):E637-E646. Epub 2013 Jul 30. doi:10.1002/ccd.24778

18. Colombo A, Mikhail GW, Michev I, et al. Treating chronic total occlusions using subintimal tracking and reentry: the STAR technique. Catheter Cardiovasc Interv. 2005;64(4):407-411; discussion 412. doi:10.1002/ccd.20307

19. Carlino M, Al-Lamee R, Ielasi A, et al. Treatment of iatrogenic occlusive coronary dissections: a novel approach. EuroIntervention. 2011;7(1):106-111. doi:10.4244/EIJV7I1A18