Optimal stent deployment can become a challenge for the interventional cardiologist, especially when it involves calcified, undilatable lesions. Various technologies have been developed to tackle this scenario and the super high-pressure balloon seems to be a promising adjunct in treating undilatable lesions. Herein, we present our initial experience with a new noncompliant, super high-pressure balloon.
Calcified coronary lesions are common in coronary artery disease. These lesions are resistant and difficult to dilate, and frequently dissect during balloon angioplasty. Optimal stent deployment can become a real challenge. Suboptimal stent expansion can increase the risk of stent thrombosis and restenosis. Different strategies are used to dilate resistant lesions, including the use of a Cutting Balloon (Boston Scientific), noncompliant balloons, laser atherectomy, Rotablator (Boston Scientific), AngioSculpt scoring balloon catheter (Philips), and the buddy wire technique.
Recently, a new noncompliant balloon, the OPN NC super high-pressure percutaneous transluminal coronary angioplasty balloon (SIS Medical AG), has become available in Europe. The OPN is a double-layered balloon allowing for very high pressure dilation. We report our first experience with this new balloon in the treatment of a calcified lesion resistant to dilation by conventional noncompliant balloons.
A 72-year-old male presented to the district hospital with ongoing angina pectoris for the last 2 hours. His background involved hypertension, diabetes, and a history of coronary artery bypass 10 years prior, followed by percutaneous angioplasty with a drug-eluting stent (DES) of his circumflex coronary artery 3 years later. The result of the angioplasty was not satisfactory, with no expansion of the stent and residual compression in the hourglass, causing a residual stenosis of 50% despite a 26 atmospheres (atm) post dilatation with a 4 mm noncompliant balloon. The patient was hemodynamically stable with clear lungs and no observable cardiac murmurs, S3, or peripheral edema. An initial electrocardiogram (ECG) showed 3 mm of ST segment elevation in the lateral leads and 2 mm of ST segment depression in the anterior leads, consistent with an acute lateral wall ST-elevation myocardial infarction (STEMI). He was treated with 5000 units of heparin intravenously, and 300 mg of aspirin and 600 mg clopidogrel. Coronary angiography via right femoral access showed an occlusion of the proximal circumflex by stent thrombosis within the extrinsic compression zone of the stent and a highly calcified lesion (Figure 1).
A 6 French (Fr) Extra Backup (EBU) 100 cm MB1 coronary guiding catheter (Medtronic) was positioned at the left main coronary artery ostium. The lesion was crossed with a .014-inch x 190 cm straight Hi-Torque Whisper MS guidewire (Abbott Vascular), but TIMI grade 0 flow persisted. It was decided to perform thrombus aspiration and an Eliminate aspiration catheter* (Terumo Europe) was directed to the lesion. The suction of thrombus resulted in the restoration of TIMI grade III flow. The calcified lesion was initially prepared using rotational atherectomy with a 1.75 mm burr. It was predilated with a 3.5 mm x 12 mm NC Quantum Apex Monorail PTCA balloon (Boston Scientific) and a 3.5 mm x 15 mm Cutting Balloon. However, there was still restriction in balloon expansion (Figure 2). A 3 mm x 10 mm OPN NC balloon was used to dilate the residual resistant stenosis and inflated to 40 atm (Figure 3), allowing the rupture of the lesion, followed by prolonged post dilation with a 4.0 mm x 15 mm NC Quantum Apex Monorail balloon. A drug-eluting stent was deployed, achieving an excellent angiographic result (Figure 4).
Fibrocalciﬁc plaques reduce vessel distensibility, and impair full, uniform balloon dilatation and subsequent stent expansion.1,2 Various technologies have been developed in order to tackle this problem, including the Cutting Balloon3 and excimer laser4,5. Rotational atherectomy has been considered an adequate choice for plaque preparation when dealing with highly calcific lesions or even after balloon failure6-9; however, in larger vessels and in lesions that are not so tight, burrs might not be able to ablate the plaque10-12. The super high-pressure OPN NC balloon has been shown to be an effective and safe alternative for optimal lesion preparation and stent deployment even when conventional technologies have failed to achieve adequate expansion.13,14 In our case, dilation of the residual stenosis of the circumflex artery was not possible, despite the use of various techniques in attempts to prepare the calcified lesion, including conventional noncompliant balloons at high pressure (24 atm), Cutting Balloon, and rotational atherectomy. This led us to the OPN NC balloon, a double-layer balloon with a very low compliance. Its safety seems to be reasonable even at pressures as high as 40 atm.15 The major risk for complication with the OPN NC is coronary perforation. However, its particular properties, including an extremely low compliance and resistance to the “dog bone” effect due to its double-layer structure, can reduce the risk of coronary perforation.16 The OPN NC balloon has been available since 2012 in sizes ranging from 2.0 to 4.0 mm. It is specifically designed for the treatment of resistant, calciﬁed lesions and for the post dilatation of under-deployed stents. It allows for very high pressure inﬂation and ensures a uniform expansion over a wide range of pressures. The OPN NC balloon is highly noncompliant, with a nominal pressure of 10 atm and a nominal burst pressure of 35 atm. While more study is necessary, the success of our first experience, as well as those few cases described in the literature thus far, have been favorable for use of this balloon in the treatment of resistant, calcified lesions.17
Resistant, calcified coronary lesions are a common challenge in coronary angioplasty. Improper stent deployment increases the risk of thrombosis and in-stent restenosis. Different techniques and devices are available for the preparation and treatment of calciﬁed lesions. The OPN NC balloon, with its uniform expansion, offers a new therapeutic option that can be used safely. It provides an effective alternative strategy for the dilatation of resistant coronary lesions when conventional noncompliant balloons fail.
*The Terumo Eliminate is a dual lumen, rapid exchange manual aspiration catheter intended for removing fresh, soft emboli and thrombus from vessels in the coronary and peripheral vasculature. It has been in use in Japan for several years and has European regulatory approval (CE Mark).
Disclosure: The authors report no conflicts of interest regarding the content herein.
Contact authors via Hela Sarray, MD, at email@example.com.
- Nakamura S, Colombo A, Gaglione A, et al. Intracoronary ultrasound observations during stent implantation. Circulation. 1994 May; 89(5): 2026-2034.
- Colombo A, Hall P, Nakamura S, et al. Intracoronary stenting without anticoagulation accomplished with intravascular ultrasound guidance. Circulation. 1995 Mar 15; 91(6): 1676-1688.
- Tang Z, Bai J, Su S-P, et al. Cutting-balloon angioplasty before drug-eluting stent implantation for the treatment of severely calcified coronary lesions. J Geriatr Cardiol JGC. 2014 Mar; 11(1): 44-49.
- Reifart N, Vandormael M, Krajcar M, et al. Randomized comparison of angioplasty of complex coronary lesions at a single center. Excimer Laser, Rotational Atherectomy, and Balloon Angioplasty Comparison (ERBAC) Study. Circulation. 1997 Jul 1; 96(1): 91-98.
- Fernandez JP, Hobson AR, McKenzie D, et al. Beyond the balloon: excimer coronary laser atherectomy used alone or in combination with rotational atherectomy in the treatment of chronic total occlusions, non-crossable and non-expansible coronary lesions. EuroIntervention. 2013 Jun; 9(2): 243-250. doi: 10.4244/EIJV9I2A40.
- Brown DL, George CJ, Steenkiste AR, et al. High-speed rotational atherectomy of human coronary stenoses: acute and one-year outcomes from the New Approaches to Coronary Intervention (NACI) Registry. Am J Cardiol. 1997 Nov; 80(10): 60K-67K. doi: https://doi.org/10.1016/S0002-9149(97)00765-0.
- Couper LT, Loane P, Andrianopoulos N, et al. Utility of rotational atherectomy and outcomes over an eight-year period: RA Treats complex lesions with low procedural complications and MACE rates. Catheter Cardiovasc Interv. 2015 Oct; 86(4): 626-631. doi: 10.1002/ccd.26077.
- Dill T. A randomized comparison of balloon angioplasty versus rotational atherectomy in complex coronary lesions (COBRA study). Eur Heart J. 2000 Nov 1; 21(21): 1759-1766. Available online at https://academic.oup.com/eurheartj/article-lookup/doi/10.1053/euhj.2000.2242. Accessed June 20, 2019.
- Camnitz WM, Keeley EC. Heavily calcified coronary arteries: the bane of an interventionalist’s existence. J Interv Cardiol. 2010 Jun; 23(3): 254-255. doi: 10.1111/j.1540-8183.2010.00553.x.
- Barbato E, Carrié D, Dardas P, et al. European expert consensus on rotational atherectomy. EuroIntervention. 2015 May; 11(1): 30-36. doi: 10.4244/EIJV11I1A6.
- Mauri L, Reisman M, Buchbinder M, et al. Comparison of rotational atherectomy with conventional balloon angioplasty in the prevention of restenosis of small coronary arteries: results of the Dilatation vs Ablation Revascularization Trial Targeting Restenosis (DART). Am Heart J. 2003 May; 145(5): 847-854. https://doi.org/10.1016/S0002-8703(03)00080-2.
- Abdel-Wahab M, Richardt G, Joachim Büttner H, et al. High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: the randomized ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial. JACC Cardiovasc Interv. 2013 Jan; 6(1): 10-19. doi: 10.1016/j.jcin.2012.07.017.
- Raja Y, Routledge HC, Doshi SN. A noncompliant, high pressure balloon to manage undilatable coronary lesions. Catheter Cardiovasc Interv. 2010 Jun 1; 75(7): 1067-1073. doi: 10.1002/ccd.22430.
- Díaz JF, Gómez-Menchero A, Cardenal R, et al. Extremely high-pressure dilation with a new noncompliant balloon. Tex Heart Inst J. 2012; 39(5): 635-638.
- Secco GG, Ghione M, Mattesini A, et al. Very high-pressure dilatation for undilatable coronary lesions: indications and results with a new dedicated balloon. EuroIntervention. 2016 Jun; 12(3): 359-365. doi: 10.4244/EIJY15M06_04.
- Fabris E, Caiazzo G, Kilic ID, et al. Is high pressure postdilation safe in bioresorbable vascular scaffolds? Optical coherence tomography observations after noncompliant balloons inflated at more than 24 atmospheres. Catheter Cardiovasc Interv. 2016 Apr; 87(5): 839-846. doi: 10.1002/ccd.26222.
- Tanaka A, Jabbour RJ, Kawamoto H, et al. A super high-pressure balloon solution for a non-dilatable in-stent restenosis. Int J Cardiol. 2016 Jan; 203: 357-359. doi: 10.1016/j.ijcard.2015.10.188.