GuideLiner-Assisted Orbital Atherectomy for PCI of Calcific and Tortuous RCA Stenoses

Coronary artery calcification and severe atherosclerosis continue to pose challenges to the completion of successful percutaneous coronary intervention (PCI). Advanced age, diabetes mellitus, and renal failure are well-known risk factors for coronary artery calcification. The Diamondback 360º Coronary Orbital Atherectomy (OA) System (Cardiovascular Systems, Inc., [CSI]) is an atheroablative modality that has been FDA-approved for the management of severe coronary calcification. Increased coronary artery tortuosity can add additional challenges to PCI. The GuideLiner catheter (Teleflex), a rapid-exchange support catheter, is a coaxial guide extension system designed to enable deep vessel engagement and facilitate device delivery in highly tortuous vessels.^1-6 Increased vessel tortuosity carries an increased risk of vessel perforation during device delivery. The soft distal tip of the GuideLiner is designed to counteract this risk. It is our belief that the following two cases are the first description of the use of GuideLiner support for the distal delivery of the CSI Diamondback OA System.

Case 1 (VIDEO)

A 67-year-old male veteran with hypertension, hyperlipidemia, diabetes, severe chronic obstructive pulmonary disease, peripheral vascular disease, left bundle branch block, and tobacco and alcohol abuse presented to our service with a heart failure exacerbation and newly diagnosed systolic heart failure thought to be secondary to ischemic cardiomyopathy with an ejection fraction (EF) of 25%. He subsequently underwent coronary angiography, which revealed three-vessel disease as follows: 

1) The left main had moderate to severe distal left anterior descending coronary artery disease with a mid-vessel chronic total occlusion (CTO);

2) The right coronary artery (RCA) was a calcific, tortuous vessel with severe stenosis in the mid and distal vessel;

3) The ramus had a severe proximal stenosis. 

A thallium viability study showed viability in the anterior and inferior walls. He was referred to cardiothoracic surgery for evaluation for coronary artery bypass graft (CABG) surgery, but was rejected due to severe pulmonary disease. He was subsequently referred to cardiology for complex PCI. Transfemoral coronary angiography was performed using a 7.0 French (Fr), 10 cm sheath using the modified Seldinger technique. Due to ilio-femoral tortuosity, the sheath was exchanged over a wire for a 7.0 Fr, 45 cm long sheath. The coronary was engaged with the Judkins right 4 (JR4) catheter. The RCA was tortuous with severe mid-vessel calcification (Figure 1A). An initial attempt with a Balance Middleweight (BMW) wire (Abbott Vascular) and over-the-wire (OTW) balloon was unsuccessful. Using 6 Fr GuideLiner assistance, a Choice PT wire (Boston Scientific) via a 1.5 x 8 mm OTW balloon was used to cross the lesion and placed in the distal posterior descending artery (PDA), then exchanged for a 300 cm Viper wire (CSI). Delivery of the Diamondback OA system to the proximal RCA was attempted, but the tortuosity of the vessel would not allow for the OA system to be passed. With extra support provided by a guide extension catheter (GuideLiner V3), the Diamondback system was delivered past the first bend to near the second bend proximal to the lesion (Figure 1B). During the first pass, the Diamondback system, despite slow pecking movements, zipped beyond the lesion. Since the Diamondback system can perform atherectomy in both directions, atherectomy was performed by slowly bringing the Diamondback distal to proximal (Figure 1C). The Diamondback system was removed and OTW re-advanced over the Viper wire. The Viper wire was exchanged for a BMW wire. The mid-vessel and distal lesions were pre-dilated with a 2.0 x 15 mm compliant balloon (Figure 1D). The Mini Trek balloon (Abbott Vascular) was also used to assist with GuideLiner tracking to the distal RCA, which facilitated stent delivery (Resolute Integrity drug-eluting stent [DES] 2.5 mm x 26 mm [Medtronic]) to the PDA lesion. The mid RCA was stented using two overlapping stents (Resolute Integrity DES 3.0 x 38 mm distally and 3.0 x 15 mm proximally). The entire mid-RCA stented area was post-dilated with a 3.0 x 12 mm non-compliant balloon (Figure 1E). The final view demonstrated excellent angiographic results with adequate stent expansion and TIMI-III flow in the RCA (Figure 1F). The patient was observed overnight and discharged on 81 mg aspirin and 75 mg clopidogrel daily.

Case 2 (VIDEO)

A 75-year-old male veteran with coronary artery disease status post three-vessel CABG in 2010 (left internal mammary artery [LIMA]-LAD, saphenous vein graft [SVG]-diagonal, SVG-PDA), chronic diastolic heart failure secondary to ischemic cardiomyopathy with EF of 48%, hypertension, hyperlipidemia, diabetes, peripheral vascular disease, bilateral carotid artery disease, and tobacco use disorder presented to our service with chest pain. He was found to have a non ST-elevation myocardial infarct in 2017. He had previously undergone coronary angiography in 2012, which revealed an atretic LIMA-LAD, a severe anastomotic lesion of the SVG to the small-caliber diagonal, and a completely occluded SVG-PDA graft. He was referred to the interventional cardiology service for repeat coronary angiography, which showed: (1) A LAD CTO that back-filled from the SVG-diagonal; (2) A left circumflex artery CTO that filled distally via collaterals; (3) Severe mid and distal calcified RCA lesions; (4) The known findings described in the 2012 angiography with stable disease. 

Transfemoral coronary angiography was performed using a 7.0 Fr, 10 cm sheath using the modified Seldinger technique. The RCA was engaged with a JR4 catheter (Figure 2A). A Choice PT wire was advanced to the distal RCA. Using GuideLiner assistance (Figure 2B), an OTW balloon was advanced beyond the mid RCA lesion and into the distal vessel. This was then exchanged for a 300 cm Viper wire. With GuideLiner assistance, the Diamondback OA system with a 1.25 mm crown was placed at the origin of the lesion and orbital atherectomy was performed at 80,000 revolutions per minute (rpm) for multiple runs at less than 30 seconds per run, followed by a 30-second pause. Continuous flush was performed with normal saline with 5 mg of verapamil and 20 cc of ViperSlide lubricant (CSI). The Diamondback system was removed. Optical coherence tomography (OCT) was done to assess length and diameter of stent required. The mid RCA was stented using two overlapping stents (Resolute Integrity DES 2.5 mm x 30 mm distally [Figure 2C] and 3.0 mm x 26 mm proximally [Figures 2D-E]). The entire mid-RCA stented area was post-dilated with the stent balloon. The final view (Figure 2F) demonstrated excellent angiographic results and adequate stent expansion with TIMI-III flow in the RCA. The patient was observed overnight and discharged on 81 mg aspirin and 75 mg clopidogrel.

Discussion

The current standard of care for severe coronary artery disease is lesion preparation with balloon angioplasty, followed by deployment of a DES. Compared to non-calcified lesions, severely calcified vessels pose added risks to PCI as increased endovascular calcium inhibits mechanical stent delivery and expansion, and increases the risk of stent malapposition, damaging the drug polymer and its absorption.^7-14 Consequently, more adverse events and increased major adverse cardiac events (MACE) have been reported in this patient population.^10,12,15-17 The ARRIVE 1 and 2 registries showed that patients with moderate and severe coronary artery calcification who underwent PCI with DES had a stent thrombosis rate of 3.1% at 2-year follow-up.¹¹ Furthermore, attempts to expand severely calcified, malleable vessels with a high-pressure balloon inflation strategy significantly increases the risk of dissection. Adequate plaque modification prior to stent deployment is therefore vital for the long-term success of PCI by allowing appropriate stent expansion and possibly reducing the incidence of dissection beyond the intended area of treatment.^18-20

Atherectomy devices have historically been used as an alternative to traditional balloon angioplasty for un-dilatable lesions. Unfortunately, coronary atherectomy has been utilized in <5% of PCI patients, whereas the prevalence of moderate to severe coronary artery calcification in patients undergoing PCI is 32%.^14,15,21,22 The two most commonly used atherectomy devices in the United States are rotational atherectomy (Rotablator, Boston Scientific) and orbital atherectomy (Diamondback 360º, CSI). Rotational atherectomy uses a diamond-encrusted elliptical burr rotating concentrically at speeds from 140,000 to 180,000 rpm using a helical drive shaft and is advanced over a guidewire, whereas OA uses a 1.25 mm diamond-coated eccentric crown rotating centrifugally at speeds from 80,000-120,000 rpm.²³ Rotational atherectomy, first used in 1988, is the most commonly used atherectomy modality to date. OA was approved for use in coronary arteries in 2013 and previously had only been used in peripheral vascular disease. In these two cases, OA was chosen over rotational atherectomy due to its bidirectional ablating ability, which makes entrapment of the burr unlikely. 

The practicability of OA in treating coronary artery calcification was first described in the ORBIT I trial, which showed that optimal lesion preparation of moderate to severely calcified lesions using the OA strategy may change lesion compliance, thus facilitating stent delivery.²⁴ The pivotal ORBIT II trial established that preparation with OA helped facilitate stent delivery, and improved both acute and 30-day clinical outcomes compared with the outcomes of historic control subjects in patients with severely calcified coronary disease.^25,26 A later study showed low angiographic complications with OA in a real-world patient population.²⁷ OA has since been increasingly used for complex coronary PCIs.

Severely calcified coronary arteries are often extremely tortuous, which may pose a challenge to stent delivery and result in procedural failure. The GuideLiner extension guide catheter acts as a “mother-and-child” system to aid in device delivery in complex PCIs and highly tortuous vessels.^1-6 GuideLiner catheters have been used safely and successfully to deliver the Rotablator to severe target calcific lesions in distal vessels that are tortuous.^28,29 Here we report the novel use of a 6 Fr GuideLiner with OA. The reported cases are a clinical illustration that GuideLiner-assisted OA can be safely utilized for the preparation of a heavily calcified lesion prior to stent implantation in a severely tortuous vessel. Furthermore, the 6 Fr GuideLiner is compatible with radial access, which suggests that GuideLiner-assisted OA can also be safely delivered to target lesions via radial access. 

Conclusion

The Diamondback OA system with its dual atherectomy edge provides a unique advantage for the treatment of severely stenosed and calcified coronary lesions. The 6 Fr GuideLiner can be safely used for OA to overcome tortuosity.

References

1. Kovacic JC, Sharma AB, Roy S, et al. GuideLiner mother-and-child guide catheter extension: a simple adjunctive tool in PCI for balloon uncrossable chronic total occlusions. J Interv Cardiol. 2013; 26(4): 343-350.
2. Wiper A, Mamas M, El-Omar M. Use of the GuideLiner catheter in facilitating coronary and graft intervention. Cardiovasc Revasc Med. 2011; 12(1):68.e5-7.
3. Thomas JA, Patel J, Latif F. Successful coronary intervention of circumflex artery originating from an anomalous left main coronary artery using a novel support catheter: a case report and review of literature. J Invasive Cardiol. 2011; 23(12): 536-539.
4. Dardas P, Mezillis N, Ninios V, et al. The use of the GuideLiner catheter as a child-in-mother technique: an initial single-center experience. Heart Vessels. 2012; 27(5): 535-540.
5. de Man FH, Tandjung K, Hartmann M, et al. Usefulness and safety of the GuideLiner catheter to enhance intubation and support of guide catheters: insights from the Twente GuideLiner registry. EuroIntervention. 2012; 8(3): 336-344.
6. Mamas MA, Fath-Ordoubadi F, Fraser DG. Distal stent delivery with Guideliner catheter: first in man experience. Catheter Cardiovasc Interv. 2010; 76(1): 102-111.
7. Fitzgerald PJ, Ports TA, Yock PG. Contribution of localized calcium deposits to dissection after angioplasty. An observational study using intravascular ultrasound. Circulation. 1992; 86(1): 64-70.
8. Gilutz H, Weinstein JM, Ilia R. Repeated balloon rupture during coronary stenting due to a calcified lesion: an intravascular ultrasound study. Catheter Cardiovasc Interv. 2000; 50(2): 212-214.
9. Moussa I, Di Mario C, Moses J, et al. Coronary stenting after rotational atherectomy in calcified and complex lesions. Angiographic and clinical follow-up results. Circulation. 1997; 96(1): 128-136.
10. Mosseri M, Satler LF, Pichard AD, Waksman R. Impact of vessel calcification on outcomes after coronary stenting. Cardiovasc Revasc Med. 2005; 6(4): 147-153.
11. Ichihashi S, Kichikawa K. Role of the latest endovascular technology in the treatment of intermittent claudication. Ther Clin Risk Manag. 2014; 10: 467-474.
12. Moussa I, Ellis SG, Jones M, et al. Impact of coronary culprit lesion calcium in patients undergoing paclitaxel-eluting stent implantation (a TAXUS-IV sub study). Am J Cardiol. 2005; 96(9): 1242-1247.
13. Lee MS, Shah N. The impact and pathophysiologic consequences of coronary artery calcium deposition in percutaneous coronary interventions. J Invasive Cardiol. 2016; 28(4): 160-167.
14. Tran T, Brown M, Lasala J. An evidence-based approach to the use of rotational and directional coronary atherectomy in the era of drug-eluting stents: when does it make sense? Catheter Cardiovasc Interv. 2008; 72(5): 650-662.
15. Genereux P, Madhavan MV, Mintz GS, et al. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trials. J Am Coll Cardiol. 2014; 63(18): 1845-1854.
16. Colombo A, Stankovic G. Coronary perforations: old screenplay, new actors! J Invasive Cardiol. 2004; 16(6): 302-303.
17. Onuma Y, Tanimoto S, Ruygrok P, et al. Efficacy of everolimus eluting stent implantation in patients with calcified coronary culprit lesions: two-year angiographic and three-year clinical results from the SPIRIT II study. Catheter Cardiovasc Interv. 2010;76(5):634-642.
18. Schluter M, Cosgrave J, Tubler T, et al. Rotational atherectomy to enable serolimus-eluting stent implantation in calcified, nondilatable de novo coronary artery lesions: mid-term clinical and angiographic outcomes. Vascular Disease Management. 2007;4(3):63-69.
19. Cavusoglu E, Kini AS, Marmur JD, Sharma SK. Current status of rotational atherectomy. Catheter Cardiovasc Interv. 2004;62(4):485-498.
20. Benezet J, Diaz de la Llera LS, Cubero JM, et al. Drug-eluting stents following rotational atherectomy for heavily calcified coronary lesions: long-term clinical outcomes. J Invasive Cardiol. 2011;23(1):28-32.
21. Arora S, Panaich SS, Patel N, et al. Coronary Atherectomy in the United States (from a Nationwide Inpatient Sample). Am J Cardiol. 2016;117(4):555-562.
22. Bourantas CV, Zhang YJ, Garg S, et al. Prognostic implications of coronary calcification in patients with obstructive coronary artery disease treated by percutaneous coronary intervention: a patient-level pooled analysis of 7 contemporary stent trials. Heart. 2014;100(15):1158-1164.
23. Tomey MI, Kini AS, Sharma SK. Current status of rotational atherectomy. JACC Cardiovasc Interv. 2014;7(4):345-353.
24. Parikh K, Chandra P, Choksi N, et al. Safety and feasibility of orbital atherectomy for the treatment of calcified coronary lesions: the ORBIT I trial. Catheter Cardiovasc Interv. 2013;81(7):1134-1139.
25. Chambers JW, Feldman RL, Himmelstein SI, et al. Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II). JACC Cardiovasc Interv. 2014;7(5):510-518.
26. Lee MS, Shlofmitz E, Shlofmitz R, et al. Outcomes after orbital atherectomy of severely calcified left main lesions: analysis of the ORBIT II study. J Invasive Cardiol. 2016;28(9):364-369.
27. Lee MS, Shlofmitz E, Kaplan B, et al. Real-world multicenter registry of patients with severe coronary artery calcification undergoing orbital atherectomy. J Interv Cardiol. 2016;29(4):357-362.
28. Costanzo P, Aznaouridis K, Hoye A, Alahmar A. GuideLiner-facilitated rotational atherectomy in calcified right coronary artery: the “child” makes the difference. JACC Cardiovasc Interv. 2016;9(5):e47-48.
29. Vo M, Minhas K, Kass M, Ravandi A. Novel use of the GuideLiner catheter to deliver rotational atherectomy burrs in tortuous vessels. Case Rep Cardiol. 2014;2014:594396.

From the Department of Internal Medicine and the Division of Cardiology; 

¹Medical University of South Carolina, Charleston, South Carolina; ²Ralph H. Johnson VA Medical Center, Charleston, South Carolina

Disclosures: The authors report no conflicts of interest regarding the content herein.

The authors can be contacted via Anbukarasi Maran, MD, at maran@musc.edu.