Use of a Novel Cutting Balloon to Treat a Coronary Chronic Total Occlusion Due to In-Stent Restenosis of Multiple Layers of Under-Expanded Stents

Since publication of the hybrid algorithm for crossing coronary chronic total occlusions (CTO), use of the algorithm has been associated with increased CTO percutaneous coronary intervention (PCI) adoption, procedural efficiency, and success rates.^1-5 However, in-stent CTOs have traditionally been associated with suboptimal procedural success rates (63% to 86%).^6-9 Additionally, the treatment of in-stent restenosis (ISR) CTOs has been identified as an independent predictor of target lesion failure after CTO PCI and increased major adverse cardiovascular events (MACE) compared to CTOs that do not involve ISR.¹⁰

Stent failure leading to a CTO that involves ISR is often due to poor vessel preparation during the initial stent implantation.¹¹

This can be compounded when a second layer of stent is used to treat ISR, with even higher target lesion failure (11% at 6 months) in patients treated with a “double layer” of contemporary drug-eluting stents.¹² Given the exceptionally high target lesion failure rates when adding a third layer of stent, and that drug-eluting or coated balloons are not yet available for coronary use in the United States, operators will often rely on methods of image-guided stent optimization and atherectomy to treat recurrent ISR lesions in segments that have been previously stented twice. We present a case of a left circumflex (LCX) coronary artery CTO due to ISR of a double layer of stent, both of which were under-deployed, utilizing a novel cutting balloon (Wolverine Cutting Balloon, Boston Scientific) after oversized noncompliant balloon inflation and both laser and rotational atherectomy failed to provide adequate lumen gain.

Case Report

A 68-year-old female presented to her cardiologist’s office for the evaluation of accelerating chest pain. She had a past medical history significant for hypertension, dyslipidemia, and known coronary artery disease (CAD); she had no history of diabetes. She had previously undergone multiple PCIs to all three major epicardial vessels (right-dominant system), notably with over-lapping 3.0 x 16 mm Cypher drug-eluting stents (DES) (Cordis, A Cardinal Health company) in the mid-to-ostial LCX in 2004. She then underwent single-vessel coronary artery bypass graft surgery in 2009 for recurrent ISR of a stent in the proximal LAD. In 2015, she had a second layer of overlapping DES (3.0 x 8 mm and 3.0 x 12 mm Promus Premier [Boston Scientific]) placed in the mid-to-ostial LCX for a symptomatic ISR lesion that had developed in the previously placed Cypher stents. In 01/2017, she had recurrence of her anginal equivalent, and underwent coronary and graft angiography, which showed recurrent ISR of her LCX Promus stents. She then underwent plain old balloon angioplasty (POBA), followed by brachytherapy of this ISR segment later that month. Her ejection fraction remained stable (>50%) over time and she remained compliant with her dual antiplatelet regimen.

Unfortunately, the patient had recurrence of her anginal symptoms in 01/2018, with progression to Canadian Cardiovascular Society (CCS) class III symptoms despite treatment with three anti-anginal medications at moderate doses and enhanced external counterpulsation (EECP). Due to ongoing symptoms, she had an exercise stress echocardiogram, which showed moderate-risk inducible ischemia in the lateral distribution. She then underwent repeat coronary and graft angiography, which showed a CTO of her proximal LCX segment where brachytherapy had previously been administered. She was then referred to our CTO clinic and the decision was made to proceed with CTO PCI of the LCX, given the severity of her symptoms and stress test result despite optimal medical therapy.

We started the procedure with a 7 French (Fr) 10 cm sheath in the right radial artery and an 8 Fr 45 cm sheath in the right common femoral artery. We seated a 7 Fr 90 cm Judkins right (JR) 4 guide in the right coronary artery (RCA) and an 8 Fr 100 cm extra backup (EBU) 4.0 guide in the left main coronary artery (LMCA), and performed dual angiography (Figure 1). Given that the CTO was short in length (<20 mm), had unambiguous proximal and distal caps, and was all in-stent with a reasonable distal landing zone prior to any bifurcations, we decided to start with an anterograde wire escalation approach. We brought in a 135 cm Corsair microcatheter (Asahi Intecc) and a Runthrough wire (Terumo) to the proximal cap, then used a Pilot 200 (Abbott Vascular) to cross the proximal and distal caps. After confirming we were still in the stent architecture in multiple angiographic views, we followed the wire with the microcatheter and switched out for the Runthrough wire, confirming we were still in the true lumen of the stent distal to the distal cap of the lesion. The lesion was pre-dilated with a 2.5 mm noncompliant balloon. We brought in a 6 Fr Opticross (Boston Scientific) intravascular ultrasound (IVUS) catheter, which showed under-expansion in both layers of stents in the LCX and a minimal luminal areas (MLA) <2 mm² (Figure 2). Given the under-expanded nature of the stents, we decided to perform laser atherectomy of the lesion with a 0.9 mm Turbo-Elite laser catheter (Philips). We tried to pass a 1.4 mm laser catheter, but it would not pass the distal cap of the lesion due to an under-expanded stent strut. We serially dilated up to a 4.0 mm noncompliant balloon with excellent expansion at high pressure (20 atmospheres [atm]). However, repeat IVUS measurements showed no real change in the MLA (still <2 mm²).

We switched out the Runthrough wire for a Rotowire floppy (Boston Scientific) and performed rotational atherectomy of the lesion with a 1.5 mm burr, noting the burr to stall twice on separate runs through the distal aspect of lesion, requiring removal of the device prior to modifying the entirety of the lesion. We attempted to deliver an AngioSculpt scoring balloon (Philips) but it would not cross the lesion, so we switched out for a 3.5 mm Wolverine Cutting Balloon (Boston Scientific). It crossed easily and was inflated to the rated maximal pressure of 12 atm. We then delivered a 4.0 mm Wolverine Cutting Balloon and inflated it to maximal 12 atm throughout the lesion. After inflation with the Wolverine balloon, IVUS showed that the MLA had improved to 4 mm², confirmed on angiography (Figure 3). Prior to discharge the following day, the patient had already noted a significant improvement in angina during ambulation around the ward. On clinical follow-up 2 weeks later, the patient reported complete resolution of her chest pain, from CCS class III pre-procedure to CCS class I symptoms post-procedure.

Discussion

We present a case of a LCX CTO due to recurrent ISR within a double-layer of DES refractory to brachytherapy in the past year that required the use of a novel cutting balloon to achieve a more durable POBA result after failure of laser and rotational atherectomy. Treatment of ISR lesions, even in the DES era, is problematic, particularly in the United States where drug-coated/eluting balloons are not approved for intracoronary use. The ISAR-DESIRE and RIBS III trials showed that a second layer of DES is the treatment of choice for ISR involving one layer of stent (drug-eluting or bare metal).^12,13 However, the best approach to patients presenting with recurrent ISR in a second layer of stent remains unsettled.¹⁴ Many of these patients have resistant non-expandable stents despite the use of noncompliant balloons at high pressures. When resistant under-expansion is confirmed via intracoronary imaging, there have been reports of highly aggressive strategies, including rotational atherectomy, to correct this underlying problem (stent ablation).¹⁵ In this case, after failure of both laser and rotational atherectomy, we were able to successfully utilize a novel cutting balloon to achieve a reasonable MLA via IVUS and hopefully a more durable POBA result. However, further study is needed to evaluate whether this technique is a safe and reproducible treatment for ISR, particularly in lesions with under-expanded stents.

Conclusion

We present a case report describing the treatment of a left circumflex coronary artery CTO due to ISR of a double layer of stent utilizing a novel cutting balloon (Wolverine Cutting Balloon, Boston Scientific) after oversized noncompliant balloon inflation and both laser and rotational atherectomy failed to provide adequate lumen gain. Further study is needed to evaluate whether this device can be used as a safe and reproducible treatment for ISR, particularly in lesions with under-expanded stents. 

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