Adjunctive tools: Atherectomy devices, laser, thrombectomy


Key points

  • Intracoronary calcification creates significant challenges for interventional procedures due to suboptimal stent expansion and associated poor long-term clinical outcomes.

  • Atherectomy tools are designed for modification of intracoronary calcification to allow balloon and stent expansion. Coronary thrombus presents a separate challenge and selective use of thrombectomy may improve outcomes.

  • Other “niche” devices, including thrombectomy catheters and embolic protection filters are infrequently used but have benefit in carefully selected patients.

Introduction

Atherectomy devices were originally developed as a tool to decrease restenosis rates after PTCA. The use of atherectomy has changed considerably over the previous three decades. Rotational atherectomy (RA, introduced in 1988), helium laser angioplasty (ELCA, introduced in 1990), cutting balloon angioplasty (CBA, introduced in 1991), and orbital atherectomy (OA, introduced in 2008) have all been brought into routine use. Although the long-term results of these devices did not fulfill the promise of lowering the rates of target vessel revascularization with PTCA, the current era uses them to debulk heavily calcified vessels to facilitate delivery of stents and improve procedural results.

Rotational atherectomy

Mechanism of action

The principal mechanism for RA is differential cutting in which the diamond-tipped burr drills through rigid atherosclerotic plaque and calcium but spares the underlying elastic arterial structure. The resultant particulate matter is generally less than 10 μm in diameter, which passes through the microcirculation and is picked up by the reticuloendothelial system (without hindering the coronary microcirculation).

Indications and contraindications

Although studies have shown that routine use of RA may not render a clinical benefit, there are several scenarios in which RA improves immediate angiographic results. Most commonly it is used to prepare vessels with severe fibrocalcific disease where in balloons or stents could not be passed. Additionally, attempts to pass stents through such ridgid, calcific lesions may result in inappropriate positioning, stent dislodgement, or erosion of the polymer–drug coating and inadequate drug delivery to the vessel wall.

Another scenario involving highly calcified nonyielding lesions is the need for high-pressure balloon expansion because of increased vessel stiffness, risking balloon rupture and vessel dissection or perforation. Delivering a stent in an incompletely dilated lesion inhibits its full expansion, which is a clear risk for stent thrombosis.

RA is also used to debulk bifurcation lesions to reduce plaque shift or the “snow-plowing” effect. Nevertheless, caution is advised in these scenarios because of the increased risk of dissection or perforation. Angulation of more than 60 degrees (between the main vessel and side branch) is a relative contraindication for RA, and bends of more than 90 degrees have a strong contraindication. Other contraindications are summarized in Table 6.1 . A lesion that is more than 25 mm in length has a relative contraindication for RA. Smaller (<1.5mm) sized burrs should be used in these lesions should the operator so choose. A reduced ejection fraction (<30%) was previously a contraindication to RA, but the advent of mechanical support devices such as the Impella catheter has allowed physicians to consider RA for some of these patients (see Chapter 10 for more details).

Table 6.1
Indications and Contraindications to Rotational Atherectomy
Indicated High-Risk Contraindicated
  • Single-vessel atherosclerotic coronary artery disease with a calcified plaque that can be passed with a guidewire

  • Low-risk, multivessel coronary artery disease

  • De novo lesion < 25 mm in length

  • Severe, diffuse multivessel coronary artery disease

  • Unprotected left main PCI

  • Patients with compromised LV function (LVEF < 30%)

  • De novo lesion > 25 mm in length

  • Severely angulated (>45 degrees) lesions

  • Last remaining conduit with compromised LV function

  • Angiographic evidence of thrombus

  • Occlusions where a guidewire cannot be passed

  • Saphenous vein graft PCI

  • Angiographic evidence of significant dissection Type C or greater at the treatment site

LV , Left ventricular; LVEF , left ventricular ejection fraction; PCI , percutaneous coronary intervention.

Device

The Rotablator system (Boston Scientific, Natick, MA) consists of a nickel-coated brass burr ( Fig. 6.1A and 6.1 B ) that is coated with 2000 to 3000 microscopic diamond crystals that are 20 μm in size (with only 5 μm protruding from the nickel coating on its leading face). The burr is available in 1.25- to 2.50-mm sizes (0.25-mm increments) and is attached to a long, flexible drive shaft that is covered in a 4.3F Teflon sheath. The drive shaft can be inserted through various coronary guide catheters based on size ( Table 6.2 ) over a RotaWire, which is 0.009 inch in diameter and 330 cm in length. The drive shaft is connected to an advancing console ( Fig. 6.2 ) that houses a turbine driven by compressed nitrogen gas and that can rotate at speeds ranging from 140,000 to 220,000 rpm ( Table 6.3 ). An emulsifier solution (Rotaglide) made of egg yolk, EDTA, and olive oil is infused along with saline via a pressurized system through the driveshaft to reduce friction and improve heat dissipation. The traditional Rotablator RA system involved the use of a foot pedal, console, and advancer. This has been largely replaced by the newer RotaPro RA system, which has added a digital console, eliminated the foot pedal, added buttons to the advancer that control device activation, and added a switch to turn to Dynaglide mode for easy burr retrieval.

Figure 6.1, (A) The RotaPro atherectomy system replaces the foot pedal with an advancer. A digital console has also been added. (B) Diagram of the rotational atherectomy burrs available between 1.25 to 2.5 mm.

Table 6.2
Recommended Guide Catheter Sizes for Use With the Coronary Rotablator
Rotablator Burr Size (mm) Reference Vessel Diameter (mm) Minimum Guide Size (French) a
1.25 2.5 5
1.50 3.0 6
1.75 3.5 6
2.00 4 7
2.15 4.3 7
2.25 4.5 8
2.50 5 9

a For a given size of catheter, the inside diameter varies from manufacturer to manufacturer. French sizes assume thin-wall (high-volume flow) catheters with side holes.

Figure 6.2, Rotablator advancer unit: The latest version incorporates all the controls on to the advancer. Ergonomic dynaglide design allows easy system removal. All individual cables have been added onto a hybrid harness.

Table 6.3
Recommended Rotablator Advancer Turbine Speed
Burr Size (mm) Burr Size (French) Design Rotational Speed Range (rpm) a Optimum Rotational Speed Range (rpm; No Tissue Contact)
1.25 3.75 140,000–160,000 160,000
1.50 4.50 140,000–160,000 160,000
1.75 5.25 140,000–160,000 160,000
2.00 6.00 140,000–160,000 160,000
2.15 6.45 130,000–140,000 140,000
2.25 6.75 130,000–140,000 140,000
2.50 7.50 130,000–140,000 140,000
Rotablator Catheter Sheath Outer Diameter
Size (mm) Size (French) Size (inch)
1.35 4.0 0.058

a Preset speed outside of the body at the higher rotational speed—for example, for a 1.25 mm Rotablator advancer, set speed outside body at 190,000 rpm.

Technical tips

Once the decision to use RA is made based on the indications and contraindications discussed earlier, the next step is to determine the burr size. For patent but stenotic vessels, a burr-to-artery ratio of less than 0.6 is appropriate. Although a larger ratio (>0.6) can aggressively debulk the lesion, it can increase the risk of dissections and perforations. For vessels with subtotal occlusions where the arterial size is difficult to ascertain, it is prudent to start with a small burr size (1.25 or 1.5 mm) to create a pilot channel and then upsize to a ratio of less than 0.6. Additionally, a smaller burr-to-artery ratio should also be used for vessels with lesions that are longer than 25 mm or if the vessel has mild tortuosity.

The next step is preparing the patient for RA. The patients usually already have aspirin on board; some operators use verapamil preemptively to prevent spasm. Heparin or bivalirudin can be given next to fully anticoagulate the patients. Traditionally, operators have chosen heparin because of its reversibility in case of vessel perforation, but studies have shown safety with bivalirudin as well. RA is associated with rotational speed-dependent platelet activation, and glycoprotein (GP) IIb/IIIA receptor antagonists can be used to counteract this effect. Standard use of temporary pacemakers before intervening on calcified lesions in the RCA left main is no longer needed. Smaller burrs at lower speeds have led to lower incidence of transient heart block. Many operators opt to use atropine, aminophylline, or vagolytic maneuvers as part of initial management of bradyarrhythmias, avoiding any complications of temporary pacemaker placement on a routine basis. Alternatively, a test run can be performed before RA of the RCA or dominant left circumflex to make sure bradycardia is not being induced.

A guide catheter with a gentle curve should be sized depending on the burr size (see Table 6.2 ). It is important to make sure that the guide catheter is coaxial to the vessel to prevent dissection of the vessel or retraction of the wire during RA. The RotaFloppy wire should be used for lesions that are more proximal and easily crossable to prevent guidewire bias in which a burr would differentially debride more on the lesser curvature of the vessel, which is straightened by a stiffer wire. The extrasupport RotaWire can be used for difficult-to-cross, heavily calcified or distal lesions. If a lesion cannot be crossed by the RotaWire, a 0.014-inch guidewire can be used to cross the lesion and then be exchanged for the RotaWire using a low-profile over-the-wire balloon or microcatheter.

Once the RA manifold is assembled, the burr speed is tested outside the body (140,000–160,000 rpm). Either saline or the Rotaflush solution (mix 4 mg of nitroglycerin and 5 mg of verapamil in 500 mL of saline to decrease spasm) is used to flush and lubricate the system. The Rotaglide solution is added to reduce friction. Before inserting the burr into the Y-adapter, one must also check for free movement of the burr with the advancer and test that the braking system holds the wire in place during rotation. The advance knob should be locked 2 cm from the distal end of its slidder slot.

After this, the burr is inserted via a Y-adapter and advanced over the wire through the guide catheter into the vessel to about 1 to 2 cm proximal to the lesion. The operator should hold the back end of the wire and apply gentle traction on the guidewire and catheter to limit acquired tension and thereby prevent the burr from leaping forward during the initial pass. This acquired tension is alleviated further by transiently activating the system proximal to the lesion. The system is then activated and the burr is brought into contact with the lesion in a “pecking” fashion in which 1 to 3 seconds of contact with the plaque is followed by pulling back the burr from the plaque surface for 3 to 5 seconds. This decreases the risk of sudden deceleration of the burr and allows the debris to clear from the distal circulation. It is important to prevent deceleration over 5000 rpm because such decelerations can lead to plaque heating, torsional dissection of the vessel, and formation of larger particles, which can lead to slow reflow or no reflow. Another important consideration during RA is that the operator should hold gentle forward pressure on the guide catheter and the wire to maintain wire position in the distal vessel. The total time taken for each pass should not exceed 30 seconds. There should be a 30- to 60-second interval wait between each atherectomy run to avoid no reflow phenomenon. Fig. 6.3 and demonstrate the use of RA in a severe left main stenosis. The slow pecking technique is important to prevent device entrapment beyond the target lesion, which is a rare but serious complication requiring expertise to extract the device or emergent surgery if other measures fail.

Figure 6.3, Case example using rotational atherectomy (RA) in the treatment of fibrocalcific left main (LM) and left anterior descending (LAD) disease. (A–B) Baseline angiography demonstrating calcified plaque of the LM and LAD in caudal and cranial projections. (C) RA using a 1.5-mm burr. (D) Post-RA angiography. (E) Stent deployment into the LAD. (F) Stenting of the LM into the LAD. (G) Angiography of the LM and LAD post stenting. PTCA , Percutaneous transluminal coronary angioplasty.

The most important factor in successfully using RA is to avoid complications such as dissection, perforation, and preventing no reflow or slow reflow (reduction in blood flow by 1 thrombolysis in myocardial infarction [TIMI] grade). Technical tips to prevent these adverse effects are listed in Box 6.1 . When performed by an experienced operator with the appropriate precaution, RA proves to be an excellent method to debulk and modify plaque in preparation for stenting – with recent data suggesting that operator experience (i.e., number of cases performed every year) significantly reduces the occurrence of complications.

Box 6.1
Technical Notes and Tips on Performing Rotational Atherectomy

  • A nitrogen compressed-gas cylinder with pressure regulator capable of delivering a minimum 140 L/min at 90 to 100 psi is required.

  • The compressed-gas cylinder valve must be open to supply compressed gas to the console. The regulator should be adjusted so that the pressure does not exceed 100 psi.

  • Angulated lesions and branch ostial lesions have a higher incidence of dissection and/or perforation; downsize initial burrs and stepwise increase burr size to achieve the final result.

  • Rotational atherectomy (RA) can be performed on chronic total occlusions only if the guidewire is confirmed to be in true lumen distally.

  • Perforations are uncommon. Covered stents should be available in all cardiac catheterization laboratories performing RA.

Orbital atherectomy (OA)

The Diamondback 360-degree OA system (Cardiovascular Systems, St. Paul, MN) uses a diamond-coated crown (available in sizes 1.25–2.00 mm at 0.25-mm increments; Fig. 6.4 ) that orbits eccentrically over a coil made of three spiral wires. The elliptical motion of the crown is different from the burr used for RA such that the diameter and the depth of the OA depend on the velocity of crown rotation (80,000–200,000 rpm). Theoretically this elliptical motion of the crown makes deeper cuts and can ablate plaque in both antegrade and retrograde fashion and, at the same time, allows for greater blood flow and heat dissipation during atherectomy. The additional advantages of OA over RA are that the risk of entrapment of the device on the plaque is theoretically lower and the sanding motion results in smaller particulate matter.

Figure 6.4, A diamond-coated crown for orbital atherectomy system.

The procedural technique for OA is similar to that of RA (PTRA) except that, when selecting lesions, the operator should ensure the presence of calcium on both sides of the arterial wall using fluoroscopy or a 270-degree arc of calcium within the plaque via intravenous ultrasound (IVUS). A ViperWire (0.012-inch) can be used to cross the lesion instead of the RotaWire. Care should be taken not to advance the crown within 5 mm of the distal end of the ViperWire. The ViperSlide (composed of soybean oil, egg yolk phospholipids, glycerin, and water) solution is used for flush in place of the RotaFlush, and, unlike the RA system where the adequacy of flushing is determined by the operator, the OA system requires continuous flow of flush and automatically disables if the flow is interrupted. Finally, the preferred motion for the OA crown is slow continuous advancement as opposed to the pecking motion preferred for RA. The potential complications of OA are similar to RA and were discussed earlier.

To date, no randomized controlled trials have compared OA versus RA during PCI. A recent meta-analysis of retrospective studies comparing OA with RA by Khan et al. revealed no difference in overall major adverse cardiac events. OA had a lower fluoroscopy time but higher odds of causing coronary dissection and perforation. Table 6.4 describes the practical aspects associated with each atherectomy modality before its use.

Table 6.4
Practical Considerations for Choice of Atherectomy Device
Choice Considerations Rotational Atherectomy a Orbital Atherectomy b
Guide Size Usually 6-French (F) or larger Usually 6F
Arterial Access Radial or femoral Radial or femoral
Ostial lesions Offers more control and the preferred choice for severe aorto-ostial lesions Ostial ablation is possible provided crown can be advanced through the lesion. Ablation has to be backward (i.e., distal to proximal)
Presence of a stent Technically challenging but feasible and reported Contraindicated
Wire Flimsy and hard to manipulate User friendly and comparable to workhorse wires
Insertion/removal Dynaglide mode helps make delivery/removal of the burr much less cumbersome. Single-operator technique being adopted at some centers Glide assist feature facilitates crown delivery often using just a single operator
Vessel size Similar to orbital atherectomy in lesions with smaller lumens. Larger vessels need gradual burr upsizing. Preferred for larger vessels because of superior debulking.
Tortuosity Tighter turns easier to navigate Better suited for straighter segments
Cutting Direction Forward Forward and backward
Foot Pedal Replaced by an advancer knob in the newer generation (Rota-Pro) No foot pedal

a Rotational atherectomy: Boston Scientific, Natick, MA, USA

b Orbital atherectomy: Cardiovascular Systems, Inc., St. Paul, MN, USA

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