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Plaque Modification of Calcified Vessels-Orbital Atherectomy
Journal of Indian College of Cardiology 6 (2016) 163–168
Contents lists available at ScienceDirect
Journal of Indian College of Cardiology journal homepage: www.elsevier.com/locate/jicc
Review Article
Plaque modification of calcified vessels-orbital atherectomy Sridhar Kasturi* Sunshine Heart Institute, Secunderabad, Hyderabad, Telangana, India
A R T I C L E I N F O
Article history: Available online 14 January 2017
1. Introduction PCI of severely calcified coronary lesions are one of the toughest lesions-to-treat populations and previous studies have shown these have worse clinical outcomes.OAS is the device to facilitate stent delivery in patients who are acceptable candidates for PCI due to de novo, severely calcified coronary artery lesions. In October 2013, Cardiovascular Systems Inc. received FDA approval for the use of the Diamondback Coronary OAS in the US. With FDA approval interventional cardiologists now have technology to treat patients with severely calcified coronary lesions. Despite advances in technology percutaneous coronary intervention of severely calcified coronary lesions remains challenges. Compared with noncalcified lesions, increased coronary arterial calcium deposition leads to a higher incidence of major adverse cardiac events (MACE), in particular the rate of non–Q-wave myocardial infarction (MI). Calcified lesions have been shown to respond poorly to percutaneous coronary intervention (PCI) and are associated with a high frequency of restenosis, target lesion revascularization (TLR) Challenges treating PCI of severly calcified coronary artery lesions is associated with many challenges like respond poorly to angioplasty, difficult to completely dilate,Prone to dissections, Interferes with stent delivery and deployment, stent thrombosis due to malapposition and Insufficient drug penetration and subsequent restenosis. CAC associated with difficulty in delivering stents associated with stent dislodgement,balloon rupture, unequal expansion of stent with increased interstrut distance, Attempts to remedy incomplete stent expansion with aggressive highpressure balloon dilation may result in coronary artery rupture or dissection,requires more balloons,wires and stents.It can be complicated procedure and a lot of time it cannot even be done. Coronary calcification is often underappreciated by conventional angiography alone. Angiographic criteria of moderate calcium:
* Corresponding author at: Sunshine Heart Institute, Paradise SD Road, Beside Paradise Hotel, Secunderabad, Hyderabad, Telangana 500003, India. E-mail address: [email protected] (S. Kasturi). http://dx.doi.org/10.1016/j.jicc.2016.12.004 1561-8811/© 2017 Indian College of Cardiology. All rights reserved.
Radiopaque densities noted only during the cardiac cycle and typically involving one side of the vascular wall and severe calcium: Radiopaque densities noted without cardiac motion prior to contrast injection and generally involving both sides of arterial wall,Mintz et al. studied 1,155 coronary native vessel target lesions.1 Calcium was detected by angiography in 38% of lesions (26% moderately, 12% severely calcified), where as intravascular ultrasound (IVUS) showed 73% of lesions to have calcium deposits, suggesting that coronary calcification is relatively common. As IVUS/OCT is an underused diagnostic modality, coronary calcification is often underestimated or considered mild or moderate via angiogram, when it may actually be confirmed as severe calcification if IVUS/OCT is used.2,3 RA is one of the current therapeutic options to manage calcified lesions but has a limited role in facilitating the dilatation and stenting of lesions that can be crossed or expanded with other PCI techniques due to unfavorable out come in long term follow up. In October 2013, Cardiovascular Systems Inc. received FDA approval for the use of the Diamondback Coronary OAS in the US, whereas it has yet to receive CE Mark in Europe.Prior to FDA approval of OAS the only treatment option available for patients with severely calcified coronary lesions was rotational atherectomy (RA) even though RA is not indicated by the FDA for that population of patients.RA studies indicated improved procedural success in severely calcified lesions; however, its use has not led to a reduction in restenosis.The latest ACCF/AHA/SCAI and ESC/EACTS PCI guidelines and European expert consensus on rotational atherectomy state that rotational atherectomy has a limited role in facilitating the dilation or stenting of lesions that cannot be crossed or expanded with PCI.4–9 Rotational atherectomy should not be performed routinely for de novo lesions or in-stent restenosis.10 The prevalence of calcium in current day PCIs based on Insight from an angiographic pooled analysis from ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) and HORIZONS (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) Trials11–14 (6855 patients) is 32% (moderate-26.1%, severe-5.1%).ADAPT-DES (11 center allcomers DES registry): Mod/Sev Calcification 30.8%, (N = 8,582 pts). Frequency of angio core lab moderate severe calcification in
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pooled data of 13 DES studies (despite being an exclusion criterion in most studies) is 29% (2,315/7,978), RAVEL- 23.3%, SIRIUS-17.1%, E-SIRIUS-16.1%, C-SIRIUS-12.0%, TAXUS-IV-18.3%, TAXUS-V- 32.5%, TAXUS-VI-29.7%, ENDEAVOR-II-23.7%, ENDEAVOR-III-17.9%, ENDEAVOR-IV- 33.2%, SPIRIT-II-31.4%, SPIRIT-III-27.8%, COMPARE38.5%. Angiographic evidence of severe calcium may be present in 6% of patients however Intra vascular imaging IVUS and OCT shows in more number of patients. ORBITAL TECHNOLOGY FOR CALCIFIED CORONARY ARTERIESOrbital burr being constructed from 3 helically wound wires (like a spring), the size of the cutting device can slightly vary according to the degree of compression, The crown, which comes at a fixed 1.25mm size, is eccentric in shape, and therefore, orbits rather than spins concentrically on the wire. Crown will only sand the hard components of plaque, Soft components (plaque/tissue) flex away from crown (Fig. 1) Increased speed leads to Increased centrifugal force results in greater centrifugal force in achieving larger orbital diameter, The device allows constant blood and saline flow and particulate flushing during orbit, which facilitates cooling, minimising the potential for ischemia which potentially decreases slow flow, no-reflow and periprocedural cardiac enzyme elevation and thermal trauma, which can be a potential cause of restenosis, Different vessel diameters can be treated based on orbiting speed using single burr, only one size of crown (1.25 mm) is required for the coronary OAS (Table 1). ViperWire Advance coronary guide wire (335 cm) is to be used exclusively with the Diamondback 360, The crown’s orbital diameter expands radially via centrifugal force according to the following formula: F = mv2/R (F = centrifugal force; m = mass of the crown; v = velocity [device rotational speed]; R = radius of rotation). Operators can control the speed of rotation with the knowledge that a higher speed will create a larger sanding diameter by increasing lateral pressure, the average particle size created by OAS is 2.04 mm; 98.3% of particles are smaller than red blood cell diameter; and 99.2% of particles are smaller capillary diameter, rotational atherectomy uses a concentric burr that does not allow blood and micro-debris to flow past the burr. The average particle size created by rotational atherectomy is 5–10 mm,15 One advantage of the Diamondback 360 Coronary OAS is the ease of use. The electric handle allows the user to simply plug in the device, and the only portion of the Diamondback 360 Coronary OAS that is not in the operating field is the saline infusion pump.16 The time
and complexity setup of RA may be longer as it requires nitrogen tank.Balloons and stents can be advanced over the viper wire to complete the PCI,where as the 0.009 rota wire used for RA does not provide adequate support to accommodate balloons and stents and requires exchange for a workhorse wire.RA amny require sequential utilization of small to larger burrs which adds to fluoroscopic and procedural time. The orbital path of the device around the periphery of the lumen allows the crown to attack the plaque, in contrast with the burr of a rotational device, which remains in one place, OAS compared to traditional established rotablation system ablation bidrectionally i,e during forward and backward motion of crown, potentially shorter treatment times and treats entire lumen not just a portion of the lumen due to its orbital motion. Both rotational and orbital atherectomy share the same limitation (Table 2) the need for a specific dedicated guidewire.9,17,18 Proposed Algorithm for Use of Rotational or Orbital Atherectomy in Management of de Novo Calcified Lesions (Fig. 2). ORBIT I Trial is a prospective, single arm study of 50 patients to assess the feasibility of OAS in mild to severely calcified coronary artery disease, conducted in two centers in India completed in 2008.This study showed In-hospital MACE: 4%, MACE 8% at 6 months, Device success was 98%, and procedural success was 94%. Of the 33 subjects, the observed MACE rate at 2 years was 15% (5/ 33), 3 years was 18% (6/33) and 5 years 21% (7/33).19–22 ORBIT II Prospective, multi-center Single arm trial to evaluate safety and efficacy of the coronary orbital atherectomy system (OAS) in 443 patient trial at 49 US sites to prepare de novo, severely calcified coronary lesions for enabling stent placement the study did not include a comparator arm because there is no FDA approved percutaneous devices for treating severely calcified coronary arteries. ORBIT II study inclusion criteria included: 1) target vessel reference diameter >2.5 mm and <4.0 mm with a stenosis >70% and <100% or a stenosis >50% and <70% with evidence of clinical ischemia via positive stress test, or fractional flow reserve value <0.8, or IVUS minimum lumen area <4.0 mm2 2) target lesion length <40 mm; 3) fluoroscopic or IVUS evidence of severe calcium deposit at the lesion site based on angiographic presence of radio opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium of at least 15 mm and extending partially
[(Fig._1)TD$IG]
Fig. 1. Orbital atherectomy, crown will only sand the hard components of plaque, soft components (plaque/tissue) flex away from crown.
Table 1 Maximum lumen diameter after orbital atherectomy with 1.25 mm classic crown. Crown size
Rotational Speed
Maximum lumen diameter (mm) Average + 2SD(10 mm/sec, 20 passes)
Maximum lumen diameter (mm) Average + 2SD(1 mm/sec, 20 passes)
1.25 1.25
80,000 120,000
1.64 1.84
1.53 1.68
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Table 2 Differential aspects of the orbital atherectomy from the rotational atherectomy.
Device Manufacturer Rotation Guidewire Lubricant Concept Device size selection
Ablation speed
Rotational Atherectomy
Orbital Atherectomy
Rotablator Rotational Atherectomy System Boston Scientific Scimed, Maple Grove, Minnesota. Rotational motion RotaWire (ROTAWIRE Floppy, ROTAWIRE Extra Support) Rotaglide Differential cutting 1.25, 1.50, 1.75, 2.00, 2.15, 2.25, 2.38, and 2.50 mm (Burr) Plaque modification with small burrs (1.25 mm to 1.5 mm) as initial strategy is default position. A step-up approach is encouraged to limit debris size and complications) Plaque modification usually achieved at low speeds (135,000 to 180,000 rpm) to reduce risk of complications No (necessary to change the burr size)
Diamondback 360 Coronary Orbital Atherectomy System Cardiovascular Systems, Inc., St. Paul, Minnesota. Orbital motion ViperWire Advance1 Guide Wire
Adjustable ablation diameter Ability to ablate forward No and backward Continuous blood flow No during ablation Flush Rotablation cocktail with verapamil,nitrates and heparin in saline recommended Particle size 5–10 mm Incidence of slow flow/ 6–15% no-reflow Coronary perforation 0.4–2.5%
into the target lesion, or presence of >270 of calcium at 1 cross section via IVUS. Patients were excluded if any of the following applied 1) the target vessel had a stent from previous PCI unless the stent was on a different branch than the target lesion and was implanted more than 30 days before with no higher than 30% in stent restenosis; 2) they had a recent MI, defined as creatine kinase myocardial band >1x upper limit of normal within 30 days prior to
ViperSlide Differential sanding 1.25 mm (Crown)
Low speed (80,000 rpm) or high speed (120,000 rpm) initial treatment for each lesion must start at low speed Yes (just control the rotational speed) Yes (minimising burr entrapment rates) Yes (minimising the potential for ischaemia and thermal trauma) No specific recommendation 2 mm 0.9% 1.8%
index procedure; 3) they were diagnosed with chronic renal failure unless under hemodialysis, or had a serum creatinine level >2.5 mg/dl; 4) there was evidence of current left ventricular ejection fraction <25% (where current is defined as the latest left ventricular ejection fraction measurement completed within the last 6 months). In-hospital MACE occurred in 43 subjects (9.8%), Secondary endpoints-Angiographic success was achieved in 91.4%
[(Fig._2)TD$IG]
Fig. 2. Current status of rotational atherectomy or orbital atherectomy-JACC.
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(405 of 443) of subjects and severe angiographic complications occurred at a rate of 7.2% (32 of 443 subjects). The ORBIT II trial is the largest series to date reporting exclusively on patients with severely calcified lesions. The ORBIT II trial found a high rate of successful stent delivery (97.7%) and residual stenosis <50% (98.6%) with a low angiographic complication rate. The incidence of slow flow and no reflow were notably very low, occurring in <1% of patients. This is in contrast to Japanese RA studies showing a range of 0% to 18%.23–26 The ORBIT II dissection (types C to F) rates for post-OAS device and final were 2.3% and 3.4%, respectively. A review of the published reports found 7 studies using RA that reported types C to F dissection rates ranging from 2.1% to 8.4%.27–33 The ORBIT II trial had among the lowest rates for this complication. Similarly, abrupt closure occurred in 0.9% (post-OAS device) and 1.8% (final) of patients in the current study compared with rates from 1% to 4% in 6 studies that reported abrupt closure during RA.34 Perforations occurred in 0.9% (postOAS device) and 1.8% (final) of patients compared with 0.4% to 2.5% in the 10 RA studies reporting on this complication.35 The post-OAS device perforation rate is at the low end of the previously reported range and the final ORBIT II perforation rate is within the range.ORBIT II reported much lower in-hospital rates of non–Q-wave and Q-wave MI at 8.6% (38 of 440) and 0.7% (3 of 440), respectively, than did previous studies evaluating coronary calcified lesions. For example, Mosseri et al.36 evaluated the effect of coronary calcification on non–Q-wave MI in patients treated with RA and bare-metal stents (Fig. 3).They demonstrated significant increases in non–Q-wave MI rates corresponding to the increase of calcium arc via IVUS: 20.9% (>270 of calcium group) compared with 8.0% (0 –90 of calcium group). Clavijo et al.37 among the very few trials that studied severely calcified lesions treated with DES with and without RA, found a non–Qwave MI (creatine kinase-myocardial band elevation >3x upper limit of normal) rate of 19.8% in the RA + DES group and a 25.8% rate in the DES-only group. They also reported an in-hospital Qwave MI rate for RA + DES group at 1.3%.There are only a few previous studies that reported TLR and death rates for patients with severely calcified coronary arteries. Mosseri et al.36 reported an in-hospital TLR rate and death rate of 1.6% each. Clavijo et al.37 reported a 30-day TLR rate of 1.3% and a death rate of 2.6% for the RA + DES group (Fig. 4). In contrast, the ORBIT II study reported a lower in-hospital TLR rate of 0.7% and a much lower cardiac death rate of 0.2%. Recnetly published ORBIT-II Study 2 years follw up results showed 30 days cardiac death-0.2%, TVR/TLR-1.4%,MI9.7%, MACE-10.4%,30 days to 1 year cardiac death-2.8%, TVR/TLR4.4%, MACE-6% and 1 year to 2 year follw up cardiac death-1.3%, TVR/TLR-2.3%,MACE-3.0%,during 2 years follow up period study did not show any myocardial infarction events between 30 days to 2 years (Fig. 5). Despite more complex lesions elderly patients with severely calcified coronary arteries had similar outcomes patients with more
[(Fig._3)TD$IG]
Fig. 3. ORBIT II non-Q-wave MI rate in severly calcified lesions (CK-MB >20% of total CK) within range of rotablator literature.
[(Fig._4)TD$IG]
Fig. 4. ORBIT II non-Q-wave MI rate in severly calcified lesions (CK-MB > 3X ULN) within range of rotablator literature.
than 75 years compared to younger patients of less than 75 years irrespective of gender when treated with OAS to facilitate stent delivery with high rates of freedom from 1-year MACE. The comparison study by Kini et al. (Table 3) assessed the mechanistic difference of impact by rotational atherectomy and orbital atherectomy with OCT.38 Although the number of the study population was limited, precise imaging analyses revealed that tissue modification with deep dissections in around a third of lesions after rotational atherectomy and orbital atherectomy; however, post-orbital atherectomy dissections were significantly deeper than post-rotational atherectomy (1.14 versus 0.82 mm; P = 0.048). Stents after orbital atherectomy were associated with a significantly lower per cent of stent strut malapposition than those after rotational atherectomy (4.36 versus 8.02%; P = 0.038).Another modification of OAS system which as a micro crown diamond coated tip with solid micro crown 1.25 mm which has speed of 50/80krpm has been undergoing evaluation in COAST trial and its resulting are yet to be published (Table 3). In comparison with rotational atherectomy, more significant modification of heavily calcified plaques by the orbital atherectomy led to better stent expansion and apposition, which might result in a lower MACE rate in the previous two landmark studies. In patients with de novo calcified lesions for whom PCI is indicated clinically, lesion modification via rotational or orbital atherectomy is appropriate in order to facilitate procedural success when calcification is severe. If calcification severity is intermediate or indeterminate by angiography, intravascular imaging with IVUS or OCT may be useful for reclassification. In the recently published largest non randomized, retrospective study of 458 patients with severe CAC who underwent OAS,rates of adverse cardiac events were low despite including a sizable number of high risk real world patients who would have been excluded from ORBIT II trial–30 day major adverse cardiac and cerebro vascular events 1.7%, death 1.3%, MI 1.1%, TVR 0%, Stroke 0.2%, stent thromobosis 0.2%, emergency CABG 0.2% and reported angiographic complications were perforations 0.7%, cardiac tamponade 0.7%, dissection 0.9% and no flow 0.7%. Successful stent delivery was high in real world registry (99%) and was similar to the results in the ORBIT II trial (97%). In ORBIT II trial 10 patients with severely calcified LMCA underwent OAS which showed it is very safe and feasible.At 2-years there were no significant difference in the 2 years MACE rate in the LMCA and non LMCA group.ORBIT II subanalysis and shlomfnitz et al. demonstrated orbital atherectomy to be feasible and safe in dialysis 11 patients with severely calcified coronary artery disease.However multiple larger randomized trials are required to prove its safety and efficacy with better long term results.
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[(Fig._5)TD$IG]
167
Fig. 5. ORBIT II study-safety.
Table 3 Trials assessing orbital atherectomy system. Study Title
Study Design
Patient number
Primary Outcome
Secondary Outcome
Results
Refs.
ORBIT I
A prospective, singlearm, multi-centre study
50
NS
Device success 98%, procedural success 94%, TLR 2%, MACE 8%
20,23,24
ORBIT II
A prospective, singlearm, multi-centre study
443
Device performance, procedural success, TLR and overall MACE rates at 6 months Procedural success and 30day MACE
Procedural success 88.9%, 30-day MACE 10.4%; 12-month MACE 16.4%; angiographic success 91.4%; severe angiographic complications 7.2%
14,39
Kini et al.
A retrospective, double-arm, singlecentre, OCT-imaging study A single-arm, singlecentre study
20 (10 OA versus 10 RA) 50 (all transradial NS approach) 15
NS
Angiographic success, severe angiographic complications, 12-month MACE NS
Deeper dissections post-OAS than post-RA (1.14 versus 0.82 mm; P4.048). Lower per cent of stent strut malapposition post-OAS than post-RA
31
NS
NS
30-day MACE 0%; radial artery occlusion rate 6%
40
Change in coronary flow reserve
Presence/absence of MACE during hospitalisation Procedural success
Still ongoing/not published
41
Still ongoing/not published
42
Ruisi et al.
Dib et al. COAST
A prospective, singlearm, multi-centre study A prospective, singlearm, multi-centre study
100
30-day MACE
MACE=major adverse cardiac events; NS=not specified; 0A(S)=orbital atherectomy (system); OCT=optical coherence tomography; TLR=target lesion revascularisation; RA=rotational atherectomy.
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2. Conclusion Based upon current evidence, OAS system is definitely superior to presently available plaque modification devices for treating moderate to severe calcified coronary arteries. OAS is associated with lower incidence of acute complications and lower MACE, TVR/ TLR rates. Inview of simplicity of usage compared to ROTA with better results showed in recently published studies OAS will be much more useful in managing moderate to severe calcified coronary arteries. References 1. Mintz GS, Popma JJ, Pichard AD, et al. Patterns of calcification in coronary artery disease: a statistical analysis of intravascular ultrasound and coronary angiography in 1155 lesions. Circulation. 1995;91:1959–1965. 2. Sotomi Y, Shammas NW, Suwannasom P, et al. Impact of the orbital atherectomy system on a peripheral calcified lesion: quantitative analysis by intravascular echogenicity. JACC Cardiovasc Interventions. 2015;8:e205–6. 3. Sotomi Y, Shlofmitz RA, Nakatani S, et al. Impact of the orbital atherectomy system on a coronary calcified lesion: quantitative analysis by light attenuation in optical coherence tomography. EuroIntervention. 2015;11:e1. 4. Kobayashi Y, Teirstein P, Linnemeier T, et al. Rotational atherectomy (stentablation) in a lesion with stent underexpansion due to heavily calcified plaque. Catheter Cardiovasc Interventions. 2001;52:208–211. 5. Brogan 3rd WC3rd, Popma JJ, Pichard AD, et al. Rotational coronary atherectomy after unsuccessful coronary balloon angioplasty. Am J Cardiol. 1993;71:794–798. 6. Authors/Task Force, Windecker S, Kolh P, et al. 2014 ESC/EACTS guidelines on myocardial revascularization: the task force on myocardial revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014;35:2541–2619. 7. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention: a report of the american college of cardiology foundation/american heart association task force on practice guidelines and the society for cardiovascular angiography and interventions. J Am Coll Cardiol. 2011;58:e44–122. 8. Levine GN, O'Gara PT, Bates ER, et al. ACC/AHA/SCAI focused update on primary percutaneous coronary intervention for patients with ST-elevation myocardial infarction: an update of the 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention and the 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American college of cardiology/American heart association task force on clinical practice guidelines and the society for cardiovascular angiography and interventions. J Am Coll Cardiol. 2015;67:1235–1250. 9. Barbato E, Carrie D, Dardas P, et al. European expert consensus on rotational atherectomy. EuroIntervention. 2015;11:30–36. 10. vom Dahl J, Dietz U, Haager PK, et al. Rotational atherectomy does not reduce recurrent in-stent restenosis: results of the angioplasty versus rotational atherectomy for treatment of diffuse in-stent restenosis trial (ARTIST). Circulation. 2002;105:583–588. 11. Stone GW, McLaurin BT, Cox DA, et al. Bivalirudin for patients with acute coronary syndromes. N Engl J Med. 2006;355:2203–2216. 12. Stone GW, Witzenbichler B, Guagliumi G, et al. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med. 2008;358:2218–2230. 13. Stone GW, Bertrand M, Colombo A, et al. Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial: study design and rationale. Am Heart J. 2004;148:764–775. 14. Mehran R, Brodie B, Cox DA, et al. The Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial: study design and rationale. Am Heart J. 2008;156:44–56. 15. Kini A, Marmur JD, Duvvuri S, et al. Rotational atherectomy: improved procedural outcome with evolution of technique and equipment. Singlecenter results of first 1000 patients. Catheter Cardiovasc Interv. 1999;46:305– 311. 16. Chambers JW, Diage T. Evaluation of the diamondback 360 coronary orbital atherectomy system for treating de novo, severely calcified lesions. Expert Rev Med Devices. 2014;11:457–466.
17. Madhavan MV, Tarigopula M, Mintz GS, et al. Coronary artery calcification: pathogenesis and prognostic implications. J Am Coll Cardiol. 2014;63:1703– 1714. 18. Tomey MI, Kini AS, Sharma SK. Current status of rotational atherectomy. JACC Cardiovasc Interventions. 2014;7:345–353. 19. Benezet J, Díaz de la Llera LS, Cubero JM, Villa M, Fernández-Quero M, Sánchez González A. Drug-eluting stents following rotational atherectomy for heavily calcified coronary lesions: long-term clinical outcomes. J Invasive Cardiol. 2011;23(1):28–32. 20. Clavijo LC, Steinberg DH, Torguson R, Kuchulakanti PK, Chu WW, Fournadjiev J, et al. Sirolimus-eluting stents and calcified coronary lesions: clinical outcomes of patients treated with and without rotational atherectomy. Catheter Cardiovasc Interventions. 2006;68(December (6)):873–878. 21. 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. 22. Abdel-Wahab M, Richardt G, Joachim Büttner H, Toelg R, Geist V, Meinertz T, 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 Interventions. 2013;6(1):10–19. 23. Sakakura K, Ako J, Wada H, et al. Comparison of frequency of complications with on-label versus off-label use of rotational atherectomy. Am J Cardiol. 2012;110:498–501. 24. Furuichi S, Tobaru T, Asano R, et al. Rotational atherectomy followed by cutting-balloon plaque modification for drug-eluting stent implantation in calcified coronary lesions. J Invasive Cardiol. 2012;24:191–195. 25. Tsuchikane E, Suzuki T, Asakura Y, DOCTORS Investigators, et al. Debulking of chronic coronary total occlusions with rotational or directional atherectomy before stenting: final results of DOCTORS study. Int J Cardiol. 2008;125:397– 403. 26. Tsubokawa A, Ueda K, Sakamoto H, Iwase T, Tamaki S. Acute and long-term outcomes of rotational atherectomy in small (<3.0 mm) coronary arteries. J Interventional Cardiol. 2003;16:315–322. 27. Furuichi S, Tobaru T, Asano R, et al. Rotational atherectomy followed by cutting-balloon plaque modification for drug-eluting stent implantation in calcified coronary lesions. J Invasive Cardiol. 2012;24:191–195. 28. Bersin RM, Cedarholm JC, Kowalchuk GJ, Fitzgerald PJ. Longterm clinical follow-up of patients treated with the coronary Rotablator: a single-center experience. Catheter Cardiovasc Interventions. 1999;46:399–405. 29. 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;80:60K–67K. 30. García de Lara J, Pinar E, Ramón Gimeno J, et al. Percutaneous coronary intervention in heavily calcified lesions using rotational atherectomy and paclitaxel-eluting stents: outcomes at one year. Rev Esp Cardiol. 2010;63:107– 110. 31. Henneke KH, Regar E, König A, et al. Impact of target lesion calcification on coronary stent expansion after rotational atherectomy. Am Heart J. 1999;137:93–99. 32. Levin TN, Holloway S, Feldman T. Acute and late clinical outcome after rotational atherectomy for complex coronary disease. Cathet Cardiovasc Diagn. 1998;45:122–130. 33. 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. 2003;145:847– 854. 34. Reisman M, Harms V, Whitlow P, Feldman T, Fortuna R, Buchbinder M. Comparison of early and recent results with rotational atherectomy. J Am Coll Cardiol. 1997;29:353–357. 35. Rathore S, Matsuo H, Terashima M, et al. Rotational atherectomy for fibrocalcific coronary artery disease in drug eluting stent era: procedural outcomes and angiographic follow-up results. Catheter Cardiovasc Interventions. 2010;75:919–927. 36. Mosseri M, Satler LF, Pichard AD, Waksman R. Impact of vessel calcification on outcomes after coronary stenting. Cardiovasc Revasc Med. 2005;6:147–153. 37. Clavijo LC, Steinberg DH, Torguson R, et al. Sirolimus-eluting stents and calcified coronary lesions: clinical outcomes of patients treated with and without rotational atherectomy. Catheter Cardiovasc Interventions. 2006;68:873–878. 38. Kini AS, Vengrenyuk Y, Pena J, et al. Optical coherence tomography assessment of the mechanistic effects of rotational and orbital atherectomy in severely calcified coronary lesions. Catheter Cardiovasc Interventions. 2015;86:1024– 1032.
Contents lists available at ScienceDirect
Journal of Indian College of Cardiology journal homepage: www.elsevier.com/locate/jicc
Review Article
Plaque modification of calcified vessels-orbital atherectomy Sridhar Kasturi* Sunshine Heart Institute, Secunderabad, Hyderabad, Telangana, India
A R T I C L E I N F O
Article history: Available online 14 January 2017
1. Introduction PCI of severely calcified coronary lesions are one of the toughest lesions-to-treat populations and previous studies have shown these have worse clinical outcomes.OAS is the device to facilitate stent delivery in patients who are acceptable candidates for PCI due to de novo, severely calcified coronary artery lesions. In October 2013, Cardiovascular Systems Inc. received FDA approval for the use of the Diamondback Coronary OAS in the US. With FDA approval interventional cardiologists now have technology to treat patients with severely calcified coronary lesions. Despite advances in technology percutaneous coronary intervention of severely calcified coronary lesions remains challenges. Compared with noncalcified lesions, increased coronary arterial calcium deposition leads to a higher incidence of major adverse cardiac events (MACE), in particular the rate of non–Q-wave myocardial infarction (MI). Calcified lesions have been shown to respond poorly to percutaneous coronary intervention (PCI) and are associated with a high frequency of restenosis, target lesion revascularization (TLR) Challenges treating PCI of severly calcified coronary artery lesions is associated with many challenges like respond poorly to angioplasty, difficult to completely dilate,Prone to dissections, Interferes with stent delivery and deployment, stent thrombosis due to malapposition and Insufficient drug penetration and subsequent restenosis. CAC associated with difficulty in delivering stents associated with stent dislodgement,balloon rupture, unequal expansion of stent with increased interstrut distance, Attempts to remedy incomplete stent expansion with aggressive highpressure balloon dilation may result in coronary artery rupture or dissection,requires more balloons,wires and stents.It can be complicated procedure and a lot of time it cannot even be done. Coronary calcification is often underappreciated by conventional angiography alone. Angiographic criteria of moderate calcium:
* Corresponding author at: Sunshine Heart Institute, Paradise SD Road, Beside Paradise Hotel, Secunderabad, Hyderabad, Telangana 500003, India. E-mail address: [email protected] (S. Kasturi). http://dx.doi.org/10.1016/j.jicc.2016.12.004 1561-8811/© 2017 Indian College of Cardiology. All rights reserved.
Radiopaque densities noted only during the cardiac cycle and typically involving one side of the vascular wall and severe calcium: Radiopaque densities noted without cardiac motion prior to contrast injection and generally involving both sides of arterial wall,Mintz et al. studied 1,155 coronary native vessel target lesions.1 Calcium was detected by angiography in 38% of lesions (26% moderately, 12% severely calcified), where as intravascular ultrasound (IVUS) showed 73% of lesions to have calcium deposits, suggesting that coronary calcification is relatively common. As IVUS/OCT is an underused diagnostic modality, coronary calcification is often underestimated or considered mild or moderate via angiogram, when it may actually be confirmed as severe calcification if IVUS/OCT is used.2,3 RA is one of the current therapeutic options to manage calcified lesions but has a limited role in facilitating the dilatation and stenting of lesions that can be crossed or expanded with other PCI techniques due to unfavorable out come in long term follow up. In October 2013, Cardiovascular Systems Inc. received FDA approval for the use of the Diamondback Coronary OAS in the US, whereas it has yet to receive CE Mark in Europe.Prior to FDA approval of OAS the only treatment option available for patients with severely calcified coronary lesions was rotational atherectomy (RA) even though RA is not indicated by the FDA for that population of patients.RA studies indicated improved procedural success in severely calcified lesions; however, its use has not led to a reduction in restenosis.The latest ACCF/AHA/SCAI and ESC/EACTS PCI guidelines and European expert consensus on rotational atherectomy state that rotational atherectomy has a limited role in facilitating the dilation or stenting of lesions that cannot be crossed or expanded with PCI.4–9 Rotational atherectomy should not be performed routinely for de novo lesions or in-stent restenosis.10 The prevalence of calcium in current day PCIs based on Insight from an angiographic pooled analysis from ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) and HORIZONS (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) Trials11–14 (6855 patients) is 32% (moderate-26.1%, severe-5.1%).ADAPT-DES (11 center allcomers DES registry): Mod/Sev Calcification 30.8%, (N = 8,582 pts). Frequency of angio core lab moderate severe calcification in
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pooled data of 13 DES studies (despite being an exclusion criterion in most studies) is 29% (2,315/7,978), RAVEL- 23.3%, SIRIUS-17.1%, E-SIRIUS-16.1%, C-SIRIUS-12.0%, TAXUS-IV-18.3%, TAXUS-V- 32.5%, TAXUS-VI-29.7%, ENDEAVOR-II-23.7%, ENDEAVOR-III-17.9%, ENDEAVOR-IV- 33.2%, SPIRIT-II-31.4%, SPIRIT-III-27.8%, COMPARE38.5%. Angiographic evidence of severe calcium may be present in 6% of patients however Intra vascular imaging IVUS and OCT shows in more number of patients. ORBITAL TECHNOLOGY FOR CALCIFIED CORONARY ARTERIESOrbital burr being constructed from 3 helically wound wires (like a spring), the size of the cutting device can slightly vary according to the degree of compression, The crown, which comes at a fixed 1.25mm size, is eccentric in shape, and therefore, orbits rather than spins concentrically on the wire. Crown will only sand the hard components of plaque, Soft components (plaque/tissue) flex away from crown (Fig. 1) Increased speed leads to Increased centrifugal force results in greater centrifugal force in achieving larger orbital diameter, The device allows constant blood and saline flow and particulate flushing during orbit, which facilitates cooling, minimising the potential for ischemia which potentially decreases slow flow, no-reflow and periprocedural cardiac enzyme elevation and thermal trauma, which can be a potential cause of restenosis, Different vessel diameters can be treated based on orbiting speed using single burr, only one size of crown (1.25 mm) is required for the coronary OAS (Table 1). ViperWire Advance coronary guide wire (335 cm) is to be used exclusively with the Diamondback 360, The crown’s orbital diameter expands radially via centrifugal force according to the following formula: F = mv2/R (F = centrifugal force; m = mass of the crown; v = velocity [device rotational speed]; R = radius of rotation). Operators can control the speed of rotation with the knowledge that a higher speed will create a larger sanding diameter by increasing lateral pressure, the average particle size created by OAS is 2.04 mm; 98.3% of particles are smaller than red blood cell diameter; and 99.2% of particles are smaller capillary diameter, rotational atherectomy uses a concentric burr that does not allow blood and micro-debris to flow past the burr. The average particle size created by rotational atherectomy is 5–10 mm,15 One advantage of the Diamondback 360 Coronary OAS is the ease of use. The electric handle allows the user to simply plug in the device, and the only portion of the Diamondback 360 Coronary OAS that is not in the operating field is the saline infusion pump.16 The time
and complexity setup of RA may be longer as it requires nitrogen tank.Balloons and stents can be advanced over the viper wire to complete the PCI,where as the 0.009 rota wire used for RA does not provide adequate support to accommodate balloons and stents and requires exchange for a workhorse wire.RA amny require sequential utilization of small to larger burrs which adds to fluoroscopic and procedural time. The orbital path of the device around the periphery of the lumen allows the crown to attack the plaque, in contrast with the burr of a rotational device, which remains in one place, OAS compared to traditional established rotablation system ablation bidrectionally i,e during forward and backward motion of crown, potentially shorter treatment times and treats entire lumen not just a portion of the lumen due to its orbital motion. Both rotational and orbital atherectomy share the same limitation (Table 2) the need for a specific dedicated guidewire.9,17,18 Proposed Algorithm for Use of Rotational or Orbital Atherectomy in Management of de Novo Calcified Lesions (Fig. 2). ORBIT I Trial is a prospective, single arm study of 50 patients to assess the feasibility of OAS in mild to severely calcified coronary artery disease, conducted in two centers in India completed in 2008.This study showed In-hospital MACE: 4%, MACE 8% at 6 months, Device success was 98%, and procedural success was 94%. Of the 33 subjects, the observed MACE rate at 2 years was 15% (5/ 33), 3 years was 18% (6/33) and 5 years 21% (7/33).19–22 ORBIT II Prospective, multi-center Single arm trial to evaluate safety and efficacy of the coronary orbital atherectomy system (OAS) in 443 patient trial at 49 US sites to prepare de novo, severely calcified coronary lesions for enabling stent placement the study did not include a comparator arm because there is no FDA approved percutaneous devices for treating severely calcified coronary arteries. ORBIT II study inclusion criteria included: 1) target vessel reference diameter >2.5 mm and <4.0 mm with a stenosis >70% and <100% or a stenosis >50% and <70% with evidence of clinical ischemia via positive stress test, or fractional flow reserve value <0.8, or IVUS minimum lumen area <4.0 mm2 2) target lesion length <40 mm; 3) fluoroscopic or IVUS evidence of severe calcium deposit at the lesion site based on angiographic presence of radio opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium of at least 15 mm and extending partially
[(Fig._1)TD$IG]
Fig. 1. Orbital atherectomy, crown will only sand the hard components of plaque, soft components (plaque/tissue) flex away from crown.
Table 1 Maximum lumen diameter after orbital atherectomy with 1.25 mm classic crown. Crown size
Rotational Speed
Maximum lumen diameter (mm) Average + 2SD(10 mm/sec, 20 passes)
Maximum lumen diameter (mm) Average + 2SD(1 mm/sec, 20 passes)
1.25 1.25
80,000 120,000
1.64 1.84
1.53 1.68
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Table 2 Differential aspects of the orbital atherectomy from the rotational atherectomy.
Device Manufacturer Rotation Guidewire Lubricant Concept Device size selection
Ablation speed
Rotational Atherectomy
Orbital Atherectomy
Rotablator Rotational Atherectomy System Boston Scientific Scimed, Maple Grove, Minnesota. Rotational motion RotaWire (ROTAWIRE Floppy, ROTAWIRE Extra Support) Rotaglide Differential cutting 1.25, 1.50, 1.75, 2.00, 2.15, 2.25, 2.38, and 2.50 mm (Burr) Plaque modification with small burrs (1.25 mm to 1.5 mm) as initial strategy is default position. A step-up approach is encouraged to limit debris size and complications) Plaque modification usually achieved at low speeds (135,000 to 180,000 rpm) to reduce risk of complications No (necessary to change the burr size)
Diamondback 360 Coronary Orbital Atherectomy System Cardiovascular Systems, Inc., St. Paul, Minnesota. Orbital motion ViperWire Advance1 Guide Wire
Adjustable ablation diameter Ability to ablate forward No and backward Continuous blood flow No during ablation Flush Rotablation cocktail with verapamil,nitrates and heparin in saline recommended Particle size 5–10 mm Incidence of slow flow/ 6–15% no-reflow Coronary perforation 0.4–2.5%
into the target lesion, or presence of >270 of calcium at 1 cross section via IVUS. Patients were excluded if any of the following applied 1) the target vessel had a stent from previous PCI unless the stent was on a different branch than the target lesion and was implanted more than 30 days before with no higher than 30% in stent restenosis; 2) they had a recent MI, defined as creatine kinase myocardial band >1x upper limit of normal within 30 days prior to
ViperSlide Differential sanding 1.25 mm (Crown)
Low speed (80,000 rpm) or high speed (120,000 rpm) initial treatment for each lesion must start at low speed Yes (just control the rotational speed) Yes (minimising burr entrapment rates) Yes (minimising the potential for ischaemia and thermal trauma) No specific recommendation 2 mm 0.9% 1.8%
index procedure; 3) they were diagnosed with chronic renal failure unless under hemodialysis, or had a serum creatinine level >2.5 mg/dl; 4) there was evidence of current left ventricular ejection fraction <25% (where current is defined as the latest left ventricular ejection fraction measurement completed within the last 6 months). In-hospital MACE occurred in 43 subjects (9.8%), Secondary endpoints-Angiographic success was achieved in 91.4%
[(Fig._2)TD$IG]
Fig. 2. Current status of rotational atherectomy or orbital atherectomy-JACC.
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(405 of 443) of subjects and severe angiographic complications occurred at a rate of 7.2% (32 of 443 subjects). The ORBIT II trial is the largest series to date reporting exclusively on patients with severely calcified lesions. The ORBIT II trial found a high rate of successful stent delivery (97.7%) and residual stenosis <50% (98.6%) with a low angiographic complication rate. The incidence of slow flow and no reflow were notably very low, occurring in <1% of patients. This is in contrast to Japanese RA studies showing a range of 0% to 18%.23–26 The ORBIT II dissection (types C to F) rates for post-OAS device and final were 2.3% and 3.4%, respectively. A review of the published reports found 7 studies using RA that reported types C to F dissection rates ranging from 2.1% to 8.4%.27–33 The ORBIT II trial had among the lowest rates for this complication. Similarly, abrupt closure occurred in 0.9% (post-OAS device) and 1.8% (final) of patients in the current study compared with rates from 1% to 4% in 6 studies that reported abrupt closure during RA.34 Perforations occurred in 0.9% (postOAS device) and 1.8% (final) of patients compared with 0.4% to 2.5% in the 10 RA studies reporting on this complication.35 The post-OAS device perforation rate is at the low end of the previously reported range and the final ORBIT II perforation rate is within the range.ORBIT II reported much lower in-hospital rates of non–Q-wave and Q-wave MI at 8.6% (38 of 440) and 0.7% (3 of 440), respectively, than did previous studies evaluating coronary calcified lesions. For example, Mosseri et al.36 evaluated the effect of coronary calcification on non–Q-wave MI in patients treated with RA and bare-metal stents (Fig. 3).They demonstrated significant increases in non–Q-wave MI rates corresponding to the increase of calcium arc via IVUS: 20.9% (>270 of calcium group) compared with 8.0% (0 –90 of calcium group). Clavijo et al.37 among the very few trials that studied severely calcified lesions treated with DES with and without RA, found a non–Qwave MI (creatine kinase-myocardial band elevation >3x upper limit of normal) rate of 19.8% in the RA + DES group and a 25.8% rate in the DES-only group. They also reported an in-hospital Qwave MI rate for RA + DES group at 1.3%.There are only a few previous studies that reported TLR and death rates for patients with severely calcified coronary arteries. Mosseri et al.36 reported an in-hospital TLR rate and death rate of 1.6% each. Clavijo et al.37 reported a 30-day TLR rate of 1.3% and a death rate of 2.6% for the RA + DES group (Fig. 4). In contrast, the ORBIT II study reported a lower in-hospital TLR rate of 0.7% and a much lower cardiac death rate of 0.2%. Recnetly published ORBIT-II Study 2 years follw up results showed 30 days cardiac death-0.2%, TVR/TLR-1.4%,MI9.7%, MACE-10.4%,30 days to 1 year cardiac death-2.8%, TVR/TLR4.4%, MACE-6% and 1 year to 2 year follw up cardiac death-1.3%, TVR/TLR-2.3%,MACE-3.0%,during 2 years follow up period study did not show any myocardial infarction events between 30 days to 2 years (Fig. 5). Despite more complex lesions elderly patients with severely calcified coronary arteries had similar outcomes patients with more
[(Fig._3)TD$IG]
Fig. 3. ORBIT II non-Q-wave MI rate in severly calcified lesions (CK-MB >20% of total CK) within range of rotablator literature.
[(Fig._4)TD$IG]
Fig. 4. ORBIT II non-Q-wave MI rate in severly calcified lesions (CK-MB > 3X ULN) within range of rotablator literature.
than 75 years compared to younger patients of less than 75 years irrespective of gender when treated with OAS to facilitate stent delivery with high rates of freedom from 1-year MACE. The comparison study by Kini et al. (Table 3) assessed the mechanistic difference of impact by rotational atherectomy and orbital atherectomy with OCT.38 Although the number of the study population was limited, precise imaging analyses revealed that tissue modification with deep dissections in around a third of lesions after rotational atherectomy and orbital atherectomy; however, post-orbital atherectomy dissections were significantly deeper than post-rotational atherectomy (1.14 versus 0.82 mm; P = 0.048). Stents after orbital atherectomy were associated with a significantly lower per cent of stent strut malapposition than those after rotational atherectomy (4.36 versus 8.02%; P = 0.038).Another modification of OAS system which as a micro crown diamond coated tip with solid micro crown 1.25 mm which has speed of 50/80krpm has been undergoing evaluation in COAST trial and its resulting are yet to be published (Table 3). In comparison with rotational atherectomy, more significant modification of heavily calcified plaques by the orbital atherectomy led to better stent expansion and apposition, which might result in a lower MACE rate in the previous two landmark studies. In patients with de novo calcified lesions for whom PCI is indicated clinically, lesion modification via rotational or orbital atherectomy is appropriate in order to facilitate procedural success when calcification is severe. If calcification severity is intermediate or indeterminate by angiography, intravascular imaging with IVUS or OCT may be useful for reclassification. In the recently published largest non randomized, retrospective study of 458 patients with severe CAC who underwent OAS,rates of adverse cardiac events were low despite including a sizable number of high risk real world patients who would have been excluded from ORBIT II trial–30 day major adverse cardiac and cerebro vascular events 1.7%, death 1.3%, MI 1.1%, TVR 0%, Stroke 0.2%, stent thromobosis 0.2%, emergency CABG 0.2% and reported angiographic complications were perforations 0.7%, cardiac tamponade 0.7%, dissection 0.9% and no flow 0.7%. Successful stent delivery was high in real world registry (99%) and was similar to the results in the ORBIT II trial (97%). In ORBIT II trial 10 patients with severely calcified LMCA underwent OAS which showed it is very safe and feasible.At 2-years there were no significant difference in the 2 years MACE rate in the LMCA and non LMCA group.ORBIT II subanalysis and shlomfnitz et al. demonstrated orbital atherectomy to be feasible and safe in dialysis 11 patients with severely calcified coronary artery disease.However multiple larger randomized trials are required to prove its safety and efficacy with better long term results.
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[(Fig._5)TD$IG]
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Fig. 5. ORBIT II study-safety.
Table 3 Trials assessing orbital atherectomy system. Study Title
Study Design
Patient number
Primary Outcome
Secondary Outcome
Results
Refs.
ORBIT I
A prospective, singlearm, multi-centre study
50
NS
Device success 98%, procedural success 94%, TLR 2%, MACE 8%
20,23,24
ORBIT II
A prospective, singlearm, multi-centre study
443
Device performance, procedural success, TLR and overall MACE rates at 6 months Procedural success and 30day MACE
Procedural success 88.9%, 30-day MACE 10.4%; 12-month MACE 16.4%; angiographic success 91.4%; severe angiographic complications 7.2%
14,39
Kini et al.
A retrospective, double-arm, singlecentre, OCT-imaging study A single-arm, singlecentre study
20 (10 OA versus 10 RA) 50 (all transradial NS approach) 15
NS
Angiographic success, severe angiographic complications, 12-month MACE NS
Deeper dissections post-OAS than post-RA (1.14 versus 0.82 mm; P4.048). Lower per cent of stent strut malapposition post-OAS than post-RA
31
NS
NS
30-day MACE 0%; radial artery occlusion rate 6%
40
Change in coronary flow reserve
Presence/absence of MACE during hospitalisation Procedural success
Still ongoing/not published
41
Still ongoing/not published
42
Ruisi et al.
Dib et al. COAST
A prospective, singlearm, multi-centre study A prospective, singlearm, multi-centre study
100
30-day MACE
MACE=major adverse cardiac events; NS=not specified; 0A(S)=orbital atherectomy (system); OCT=optical coherence tomography; TLR=target lesion revascularisation; RA=rotational atherectomy.
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2. Conclusion Based upon current evidence, OAS system is definitely superior to presently available plaque modification devices for treating moderate to severe calcified coronary arteries. OAS is associated with lower incidence of acute complications and lower MACE, TVR/ TLR rates. Inview of simplicity of usage compared to ROTA with better results showed in recently published studies OAS will be much more useful in managing moderate to severe calcified coronary arteries. References 1. Mintz GS, Popma JJ, Pichard AD, et al. Patterns of calcification in coronary artery disease: a statistical analysis of intravascular ultrasound and coronary angiography in 1155 lesions. Circulation. 1995;91:1959–1965. 2. Sotomi Y, Shammas NW, Suwannasom P, et al. Impact of the orbital atherectomy system on a peripheral calcified lesion: quantitative analysis by intravascular echogenicity. JACC Cardiovasc Interventions. 2015;8:e205–6. 3. Sotomi Y, Shlofmitz RA, Nakatani S, et al. Impact of the orbital atherectomy system on a coronary calcified lesion: quantitative analysis by light attenuation in optical coherence tomography. EuroIntervention. 2015;11:e1. 4. Kobayashi Y, Teirstein P, Linnemeier T, et al. Rotational atherectomy (stentablation) in a lesion with stent underexpansion due to heavily calcified plaque. Catheter Cardiovasc Interventions. 2001;52:208–211. 5. Brogan 3rd WC3rd, Popma JJ, Pichard AD, et al. Rotational coronary atherectomy after unsuccessful coronary balloon angioplasty. Am J Cardiol. 1993;71:794–798. 6. Authors/Task Force, Windecker S, Kolh P, et al. 2014 ESC/EACTS guidelines on myocardial revascularization: the task force on myocardial revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014;35:2541–2619. 7. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention: a report of the american college of cardiology foundation/american heart association task force on practice guidelines and the society for cardiovascular angiography and interventions. J Am Coll Cardiol. 2011;58:e44–122. 8. Levine GN, O'Gara PT, Bates ER, et al. ACC/AHA/SCAI focused update on primary percutaneous coronary intervention for patients with ST-elevation myocardial infarction: an update of the 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention and the 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American college of cardiology/American heart association task force on clinical practice guidelines and the society for cardiovascular angiography and interventions. J Am Coll Cardiol. 2015;67:1235–1250. 9. Barbato E, Carrie D, Dardas P, et al. European expert consensus on rotational atherectomy. EuroIntervention. 2015;11:30–36. 10. vom Dahl J, Dietz U, Haager PK, et al. Rotational atherectomy does not reduce recurrent in-stent restenosis: results of the angioplasty versus rotational atherectomy for treatment of diffuse in-stent restenosis trial (ARTIST). Circulation. 2002;105:583–588. 11. Stone GW, McLaurin BT, Cox DA, et al. Bivalirudin for patients with acute coronary syndromes. N Engl J Med. 2006;355:2203–2216. 12. Stone GW, Witzenbichler B, Guagliumi G, et al. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med. 2008;358:2218–2230. 13. Stone GW, Bertrand M, Colombo A, et al. Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial: study design and rationale. Am Heart J. 2004;148:764–775. 14. Mehran R, Brodie B, Cox DA, et al. The Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial: study design and rationale. Am Heart J. 2008;156:44–56. 15. Kini A, Marmur JD, Duvvuri S, et al. Rotational atherectomy: improved procedural outcome with evolution of technique and equipment. Singlecenter results of first 1000 patients. Catheter Cardiovasc Interv. 1999;46:305– 311. 16. Chambers JW, Diage T. Evaluation of the diamondback 360 coronary orbital atherectomy system for treating de novo, severely calcified lesions. Expert Rev Med Devices. 2014;11:457–466.
17. Madhavan MV, Tarigopula M, Mintz GS, et al. Coronary artery calcification: pathogenesis and prognostic implications. J Am Coll Cardiol. 2014;63:1703– 1714. 18. Tomey MI, Kini AS, Sharma SK. Current status of rotational atherectomy. JACC Cardiovasc Interventions. 2014;7:345–353. 19. Benezet J, Díaz de la Llera LS, Cubero JM, Villa M, Fernández-Quero M, Sánchez González A. Drug-eluting stents following rotational atherectomy for heavily calcified coronary lesions: long-term clinical outcomes. J Invasive Cardiol. 2011;23(1):28–32. 20. Clavijo LC, Steinberg DH, Torguson R, Kuchulakanti PK, Chu WW, Fournadjiev J, et al. Sirolimus-eluting stents and calcified coronary lesions: clinical outcomes of patients treated with and without rotational atherectomy. Catheter Cardiovasc Interventions. 2006;68(December (6)):873–878. 21. 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. 22. Abdel-Wahab M, Richardt G, Joachim Büttner H, Toelg R, Geist V, Meinertz T, 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 Interventions. 2013;6(1):10–19. 23. Sakakura K, Ako J, Wada H, et al. Comparison of frequency of complications with on-label versus off-label use of rotational atherectomy. Am J Cardiol. 2012;110:498–501. 24. Furuichi S, Tobaru T, Asano R, et al. Rotational atherectomy followed by cutting-balloon plaque modification for drug-eluting stent implantation in calcified coronary lesions. J Invasive Cardiol. 2012;24:191–195. 25. Tsuchikane E, Suzuki T, Asakura Y, DOCTORS Investigators, et al. Debulking of chronic coronary total occlusions with rotational or directional atherectomy before stenting: final results of DOCTORS study. Int J Cardiol. 2008;125:397– 403. 26. Tsubokawa A, Ueda K, Sakamoto H, Iwase T, Tamaki S. Acute and long-term outcomes of rotational atherectomy in small (<3.0 mm) coronary arteries. J Interventional Cardiol. 2003;16:315–322. 27. Furuichi S, Tobaru T, Asano R, et al. Rotational atherectomy followed by cutting-balloon plaque modification for drug-eluting stent implantation in calcified coronary lesions. J Invasive Cardiol. 2012;24:191–195. 28. Bersin RM, Cedarholm JC, Kowalchuk GJ, Fitzgerald PJ. Longterm clinical follow-up of patients treated with the coronary Rotablator: a single-center experience. Catheter Cardiovasc Interventions. 1999;46:399–405. 29. 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;80:60K–67K. 30. García de Lara J, Pinar E, Ramón Gimeno J, et al. Percutaneous coronary intervention in heavily calcified lesions using rotational atherectomy and paclitaxel-eluting stents: outcomes at one year. Rev Esp Cardiol. 2010;63:107– 110. 31. Henneke KH, Regar E, König A, et al. Impact of target lesion calcification on coronary stent expansion after rotational atherectomy. Am Heart J. 1999;137:93–99. 32. Levin TN, Holloway S, Feldman T. Acute and late clinical outcome after rotational atherectomy for complex coronary disease. Cathet Cardiovasc Diagn. 1998;45:122–130. 33. 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. 2003;145:847– 854. 34. Reisman M, Harms V, Whitlow P, Feldman T, Fortuna R, Buchbinder M. Comparison of early and recent results with rotational atherectomy. J Am Coll Cardiol. 1997;29:353–357. 35. Rathore S, Matsuo H, Terashima M, et al. Rotational atherectomy for fibrocalcific coronary artery disease in drug eluting stent era: procedural outcomes and angiographic follow-up results. Catheter Cardiovasc Interventions. 2010;75:919–927. 36. Mosseri M, Satler LF, Pichard AD, Waksman R. Impact of vessel calcification on outcomes after coronary stenting. Cardiovasc Revasc Med. 2005;6:147–153. 37. Clavijo LC, Steinberg DH, Torguson R, et al. Sirolimus-eluting stents and calcified coronary lesions: clinical outcomes of patients treated with and without rotational atherectomy. Catheter Cardiovasc Interventions. 2006;68:873–878. 38. Kini AS, Vengrenyuk Y, Pena J, et al. Optical coherence tomography assessment of the mechanistic effects of rotational and orbital atherectomy in severely calcified coronary lesions. Catheter Cardiovasc Interventions. 2015;86:1024– 1032.