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Coronary Atherectomy: a Current Assessment

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Coronary Atherectomy: a Current Assessment CURRENT TRENDS IN PCI Coronary Atherectomy: A Current Assessment A contemporary review of atherectomy devices for treating calcified coronary artery lesions. BY EVAN SHLOFMITZ, DO n one of the initial articles on interventional cardiology, compliance may allow for complete stent expansion and Gruntzig et al noted, “At present, the technic [sic] is lead to improved procedural success. Mild to moderately limited by anatomic factors, such as vessel tortuosity… calcified lesions can often be managed with noncom- and calcified stenosis.”1 Despite the many advances in pliant balloons with high-pressure inflations, as well as Ithe field, these words proved to be prophetic, as coronary with cutting, scoring, and sculpting balloons. However, artery calcification continues to pose many challenges to moderate to severely calcified lesions often require an successful percutaneous coronary intervention (PCI). atherectomy strategy for optimal lesion preparation. Coronary artery calcification increases the complexity of Following atherectomy, stent delivery should utilize the PCI, with less favorable results than in noncalcified lesions. latest-generation drug-eluting stent, whenever possible, Severely calcified lesions increase the risk of dissection, to minimize restenosis. inhibit stent delivery and adequate stent expansion, and The atherectomy devices that are currently commercially are prone to stent malapposition with insufficient drug available differ by design and mechanism of action. The penetration.2-6 These factors may contribute to increased unique mechanisms of action help to determine which restenosis and stent thrombosis.4,6 Failure to pretreat device is best suited for different types of lesions. The calcified lesions may lead to increased major adverse car- following sections provide an overview of these ather- diac events (MACE).7 The true impact of calcified lesions ectomy modalities, with a particular focus on rotational is hard to fully appreciate because patients with severely and orbital atherectomy, as they are the two modalities calcified coronary artery disease are often excluded from in current use for severely calcified coronary lesions to randomized prospective trials. Pooled analysis from the facilitate stent delivery. HORIZONS-AMI and ACUITY data demonstrated a rela- tionship between the severity of target lesion calcifica- LASER ATHERECTOMY tion and adverse outcomes, including MACE, death, and Laser atherectomy has been used in the clinical setting target lesion revascularization.8 since 1983.10 The ELCA coronary laser atherectomy cath- Risk factors associated with coronary artery calcifica- eter (Spectranetics Corporation) delivers a high-energy tion, including advanced age, diabetes, kidney disease, and light beam via a specialized catheter with short pulses, smoking, have been increasing in prevalence. Coronary vaporizing thrombi, and debulking plaque. The ELCA calcium is often underestimated and undertreated. In device is approved for the treatment of lesions that an intravascular ultrasound (IVUS) analysis, Mintz et al previously failed PCI, total occlusions traversable by a showed that target lesion calcification was only seen in guidewire, occluded saphenous vein grafts, in-stent reste- 38% of lesions via angiography but was detected in 73% nosis prior to brachytherapy, ostial lesions, long lesions of lesions when utilizing IVUS.9 (> 20 mm), and moderately calcified lesions.11 Lesion preparation prior to PCI has become increas- The CARMEL multicenter study enrolled 151 acute ingly important when calcified coronary disease is pres- myocardial infarction patients with a large thrombus ent. Restenosis is frequently due to inadequate vessel burden and showed that excimer laser angioplasty was preparation because balloon angioplasty alone is often successful in 91% of patients treated, with an 8.6% rate inadequate to optimally treat severely calcified lesions. of MACE.11 Use for in-stent restenosis was demonstrated Lesion preparation alters the morphology of the lesion, to be safe in the LARS multicenter registry, in which laser changing the lesion compliance. Modification of lesion angioplasty decreased 30-day target vessel revascularization. VOL. 11, NO. 1 JANUARY/FEBRUARY 2017 CARDIAC INTERVENTIONS TODAY 39 CURRENT TRENDS IN PCI At 1 year, however, there was no significant reduction.12 inelastic plaque, resulting in debris with an average size The CORAL study demonstrated the feasibility of the of < 5 μm.16 Rotational atherectomy has been the most ELCA device in diseased vein grafts in 98 patients, with commonly used atherectomy modality to date. It is com- comparable 30-day MACE (18.4%) to the control group mercially available as the Rotablator atherectomy system (19.4%) in the comparative SAFER trial.13 (Boston Scientific Corporation) and incorporates a dia- mond-tipped elliptical burr, which spins concentrically as DIRECTIONAL ATHERECTOMY it advances in a forward direction. A cocktail consisting Directional coronary atherectomy (DCA) was approved of RotaGlide lubricant (Boston Scientific Corporation), for use by the US Food and Drug Administration (FDA) verapamil, nitroglycerin, and heparin can be infused dur- in 1990.14 A DCA catheter is equipped with a rotating ing ablation to reduce vasospasm. The Rotablator system cutter that ablates plaque through a small window with is controlled using a console, with activation by a foot the assistance of an inflated balloon. The rotating cutter pedal. Available crown sizes vary from 1.25 to 2.5 mm. is advanced distally, ablating the lesion and aspirating Rotational atherectomy increases lumen diameter by the debris. DCA is capable of debulking lesions with ablating calcium and achieving plaque modification. mixed morphologies. However, in the United States, it The ERBAC study included 685 patients from a single is no longer commercially available for use in the coro- center who were randomized to one of three revascular- nary arteries and can only be used for treatment of the ization strategies. No significant differences were observed peripheral vasculature. for in-hospital adverse events and at 6-month follow-up, despite the enhanced procedural success with rotational TRANSLUMINAL EXTRACTION CATHETER atherectomy.17 The results of the COBRA study were Transluminal extraction catheter (TEC) atherectomy not significantly different.18 A meta-analysis of random- simultaneously excises and extracts plaque and thrombi15 ized atherectomy trials published in 2004 suggested that and received FDA approval in 1993. TEC was used to the combined experience indicated that ablative devices treat lesions of heterogeneous morphology and in bypass failed to achieve predefined clinical and angiographic grafts prior to angioplasty. TEC is no longer commercially outcomes.19 In the contemporary ROTAXUS trial, routine available. lesion preparation using rotational atherectomy did not reduce late lumen loss of drug-eluting stents at 9 months ROTATIONAL ATHERECTOMY in patients with moderate to severe coronary calcium. Rotational atherectomy was first used in 1988 and uses However, the use of rotational atherectomy did result in high-speed (140,000–180,000 rpm) rotation to ablate a significantly higher procedural success rate compared TABLE 1. SUMMARY OF KEY ROTATIONAL ATHERECTOMY CLINICAL DATA First Author/ Year Study Design No. of Conclusion Trial Name Published Patients ERBAC study17 1997 Single-center, 685 No major difference was observed with in-hospital randomized study complications and 6-month follow-up in RA vs laser atherectomy vs balloon angioplasty COBRA study18 2000 Multicenter, 502 Long-term clinical and angiographic outcomes are prospective study comparable between RA and balloon angioplasty Bittl et al19 2004 Meta-analysis of 9,222 Combined data did not support the hypothesis that randomized trials routine ablation is beneficial during PCI Rathore et al21 2010 Retrospective series 516 RA can be performed with high success rates and low complications, and RA followed by DES significantly reduced restenosis rates as compared to RA + BMS ROTAXUS trial20 2013 Multicenter, 240 Routine lesion preparation using RA did not reduce prospective, late lumen loss of DES at 9 months in patients with randomized moderate to severe coronary calcium controlled trial Abbreviations: BMS, bare-metal stent; DES, drug-eluting stent; RA, rotational atherectomy. 40 CARDIAC INTERVENTIONS TODAY JANUARY/FEBRUARY 2017 VOL. 11, NO. 1 CURRENT TRENDS IN PCI to standard PCI.20 A summary of key clinical data on rota- speed. The standard crown size is 1.25 mm. ViperSlide tional atherectomy is presented in Table 1.17-21 lubricant (Cardiovascular Systems, Inc.) is infused during Procedural complications that occur with rotational ablation. atherectomy include dissection, perforation, slow flow/ The orbiting mechanism utilizes centrifugal forces no reflow phenomenon, burr entrapment, vasospasm, to increase the lumen diameter by differentially ablat- and transient heart block. Procedural complications may ing calcium. The recommended duration of treatment be reduced by adhering to proper technique (ie, slower is 20 seconds or less per pass. The unique mechanism of speeds, short runs [< 20 sec] and limited deceleration action of orbital atherectomy allows continuous flow of [< 5,000 rpm]). Although it has been recommended blood and saline during orbit, decreasing heat genera- to insert a temporary transvenous pacemaker prior to tion. Microparticulate debris averages < 2 μm in size. The treatment with
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