Petros S. Dardas

*St Luke's Hospital, Thessaloniki Greece* 

#### **1. Introduction**

180 Coronary Interventions

Spaulding C. (2011) The NEVO RES-1 study: a randomized, multi-center comparison of the

Stone G.W. (2010) Comparison of everolimus-eluting and paclitaxel-eluting stents: First

Stone G.W., Ellis S.G., O'Shaughnessy C.D., Martin S.L., Satler L., McGarry T., Turco M.A.,

Tanabe K., Serruys P.W., Grube E., Smits P.C., Selbach G., van der Giessen W.J., Staberock

Windecker S., Serruys P.W., Wandel S., Buszman P., Trznadel S., Linke A., Lenk K.,

Yeung A.C., Leon M.B., Jain A., Tolleson T.R., Spriggs D.J., Mc Laurin B.T., Popma J.J.,

Turco M. (2008) TAXUS ATLAS 3-Year Clinical Results, TCT, Washington, D.C, USA. Weisz G., Leon M.B., Holmes D.R., Jr., Kereiakes D.J., Clark M.R., Cohen B.M., Ellis S.G.,

Windecker S. (2011) BioMatrix Flx - New Generation DES, Euro-PCR, Europe.

intravascular ultrasound study. Circulation 103:192-195.

eluting stent: 2-year outcomes, EuroPCR, Paris, France.

American Medical Association 294:1215-1223.

American College of Cardiology 47:1350-1355.

non-inferiority trial. Lancet 372:1163-73.

American College of Cardiology 57:1778-1783.

Circulation 107:559-564.

D.C., USA.

coronary arteries: a quantitative coronary angiography and three-dimensional

NEVO reservoir-based sirolimus-eluting stent with the TAXUS Liberte paclitaxel-

report of the four-year clinical outcomes from the SPIRIT III trial, TCT, Washington

Kereiakes D.J., Kelley L., Popma J.J., Russell M.E. (2006) Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial. Journal of the American Medical Association 295:1253-1263. Stone G.W., Ellis S.G., Cannon L., Mann J.T., Greenberg J.D., Spriggs D., O'Shaughnessy

C.D., DeMaio S., Hall P., Popma J.J., Koglin J., Russell M.E. (2005) Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. Journal of the

M., de Feyter P., Muller R., Regar E., Degertekin M., Ligthart J.M., Disco C., Backx B., Russell M.E. (2003) TAXUS III Trial: in-stent restenosis treated with stent-based delivery of paclitaxel incorporated in a slow-release polymer formulation.

Coleman P., Hill C., Shi C., Cutlip D.E., Kuntz R.E., Moses J.W. (2006) Two-year outcomes after sirolimus-eluting stent implantation: results from the Sirolimus-Eluting Stent in de Novo Native Coronary Lesions (SIRIUS) trial. Journal of the

Ischinger T., Klauss V., Eberli F., Corti R., Wijns W., Morice M.C., di Mario C., Davies S., van Geuns R.J., Eerdmans P., van Es G.A., Meier B., Juni P. (2008) Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised

Fitzgerald P.J., Cutlip D.E., Massaro J.M., Mauri L. (2011) Clinical evaluation of the RESOLUTE zotarolimus-eluting coronary stent system in the treatment of de novo lesions in native coronary arteries: the RESOLUTE US clinical trial. Journal of the In the field of interventional cardiology, heavily calcified coronary lesions (HCCL) pose great technical challenges and are associated with a high frequency of restenosis and target lesion revascularization (TLR) (Moses et al, 2004). The prevalence of severe calcium, defined as superficial (calcium at the intimal-lumen interface or closer to the lumen than to the adventitia) with greater than 180° arc, is estimated to present itself in 12% of cases using angiographic imaging. When IVUS guidance is used, it is seen in approximately 26% of cases (Figure 1) (Mintz et al, 2005).

Fig. 1. Calcium distribution: Left: 1800, in the center: 2700, Right: superficial and deep

Occasionally, the degree of calcification and/or the geometry of the plaque prevent the crossing of the lesion with balloon or stent. Adequate lesion preparation before stent implantation remains an essential component of contemporary practice of coronary stent implantation in patients with complex lesions to improve both immediate and long-term outcomes. In heavily calcified lesions preparation with high-pressure balloon inflation may occasionally succeed but is often inadequate, or may create vessel wall rupture (undilatable lesion, figure 2) (Hoffmann et al, 1998).

In an attempt to overcome challenges posed by calcification, a number of devices and techniques have been developed. One such advance is rotational atherectomy, in which a rotating brass burr (figure 3) mounted on a flexible drive shaft and coated with diamond chips pulverizes a portion of the fibrous, calcified, inelastic plaque, modifies the

Rotablation in the Drug Eluting Stent Era 183

Whether the benefit of DES persists after the vessel injury caused by rotational atherectomy is unknown. Rotablation followed by DES implantation (Rota-DES) for complex severely calcified lesions is a rational combination that has not been thoroughly evaluated. The limited studies with rotablation and DES showed promising results with no long term safety concerns. In these studies, a subtle observation was made suggesting that rotablation prior to DES implantation in such lesions may have an add-on effect on long term outcome compared to DES alone (Clavijo et al, 2006; Rao et al, 2006; Khattab et al, 2007). Therefore, the goal of this chapter is to investigate the immediate and long term outcomes of patients who are treated with rotational atherectomy to facilitate the delivery of DES in heavily calcified lesions. In addition, a full overview of the technique, the pros and cons, the advantages and complications and its applications in various lesion subsets will be provided.

The technique of RotA was invented at the start of the 1980s by David Auth and has been used during angioplasty for more than 20 years (Reisman et al, 1996). The method is most effective in the modification of calcified plaques, facilitating stent placement during angioplasty. The treatment of HCCL (as opposed to non-calcified lesions) with angioplasty has been associated with a lower success rate and a higher incidence of complications (Wilensky et al, 2002). The geometry and inflexibility of HCCL often does not permit successful approach and correct stent deployment (Hoffmann et al, 1998). In addition, balloon dilatation and stent deployment in HCCL carry a higher risk of dissection and rupture. RotA devices use a rotating brass burr that pulverizes a portion of the fibrous, calcified, inelastic plaque, modifies the plaque compliance, and leaves a smooth, nonendothelialized surface with intact media (Mintz et al, 1992; Kovach et al, 1993). RotA is based on the principle of differential atherectomy, namely selective atherectomy of the fibrous and calcified plaque (Reisman, 1996). (Figure 5) Successful RotA results in the creation of a smooth vessel lumen, suitable for the successful performance of balloon

The findings of the various studies have created some general guiding rules for the optimized use of RotA (Brown et al, 1997; Reifart et al, 1997; Whitlow et al, 2001; Dill et al,

Histology cross-sections post balloon (left) and post Rota (right).

angioplasty and stenting at the site of the lesion (Ellis et al, 1994).

2000; Buchbinder et al, 2001; vom Dahl J et al, 2002; Goldberg et al, 2000):

Fig. 4. Histology

**2. RotA- general concepts** 

plaque compliance, and leaves a smooth, nonendothelialized surface with intact media (figure 4).

Fig. 2. Undilatable lesion

An undilatable lesion revealed by balloon inflation.

#### Fig. 3. Rotablator

The rotablator uses a rotating brass burr coated with diamond chips, mounted on to a flexible drive shaft.

Rotational atherectomy overcomes this obstacle through plaque modification of the calcified lesion; however, without adjunctive stenting, restenosis rates remain high (Warth, et al, 1994). Bare metal stents reduce restenosis rates in both calcified and noncalcified coronary lesions with and without atherectomy; however, restenosis and subsequent TLR rates continue to exceed 10-20% (Serruys et al, 1994; Fischman et al, 1994; Rankin et al, 1999; Cutlip et al, 2002). Drug eluting stents (DES) further reduce restenosis and TLR in both calcified and noncalcified lesions (Moses et al, 2003; Stone et al, 2004). Despite this benefit, the delivery of DES remains challenging in complex coronary anatomy, including eccentric, extensively calcified lesions. In order to obtain the desired long-term effectiveness of DES, successful initial implantation must be accomplished; therefore, aggressive lesion preparation becomes essential for these patient subsets.

plaque compliance, and leaves a smooth, nonendothelialized surface with intact media

The rotablator uses a rotating brass burr coated with diamond chips, mounted on to a

Rotational atherectomy overcomes this obstacle through plaque modification of the calcified lesion; however, without adjunctive stenting, restenosis rates remain high (Warth, et al, 1994). Bare metal stents reduce restenosis rates in both calcified and noncalcified coronary lesions with and without atherectomy; however, restenosis and subsequent TLR rates continue to exceed 10-20% (Serruys et al, 1994; Fischman et al, 1994; Rankin et al, 1999; Cutlip et al, 2002). Drug eluting stents (DES) further reduce restenosis and TLR in both calcified and noncalcified lesions (Moses et al, 2003; Stone et al, 2004). Despite this benefit, the delivery of DES remains challenging in complex coronary anatomy, including eccentric, extensively calcified lesions. In order to obtain the desired long-term effectiveness of DES, successful initial implantation must be accomplished; therefore, aggressive lesion

(figure 4).

Fig. 2. Undilatable lesion

Fig. 3. Rotablator

flexible drive shaft.

An undilatable lesion revealed by balloon inflation.

preparation becomes essential for these patient subsets.

Fig. 4. Histology Histology cross-sections post balloon (left) and post Rota (right).

Whether the benefit of DES persists after the vessel injury caused by rotational atherectomy is unknown. Rotablation followed by DES implantation (Rota-DES) for complex severely calcified lesions is a rational combination that has not been thoroughly evaluated. The limited studies with rotablation and DES showed promising results with no long term safety concerns. In these studies, a subtle observation was made suggesting that rotablation prior to DES implantation in such lesions may have an add-on effect on long term outcome compared to DES alone (Clavijo et al, 2006; Rao et al, 2006; Khattab et al, 2007). Therefore, the goal of this chapter is to investigate the immediate and long term outcomes of patients who are treated with rotational atherectomy to facilitate the delivery of DES in heavily calcified lesions. In addition, a full overview of the technique, the pros and cons, the advantages and complications and its applications in various lesion subsets will be provided.

#### **2. RotA- general concepts**

The technique of RotA was invented at the start of the 1980s by David Auth and has been used during angioplasty for more than 20 years (Reisman et al, 1996). The method is most effective in the modification of calcified plaques, facilitating stent placement during angioplasty. The treatment of HCCL (as opposed to non-calcified lesions) with angioplasty has been associated with a lower success rate and a higher incidence of complications (Wilensky et al, 2002). The geometry and inflexibility of HCCL often does not permit successful approach and correct stent deployment (Hoffmann et al, 1998). In addition, balloon dilatation and stent deployment in HCCL carry a higher risk of dissection and rupture. RotA devices use a rotating brass burr that pulverizes a portion of the fibrous, calcified, inelastic plaque, modifies the plaque compliance, and leaves a smooth, nonendothelialized surface with intact media (Mintz et al, 1992; Kovach et al, 1993). RotA is based on the principle of differential atherectomy, namely selective atherectomy of the fibrous and calcified plaque (Reisman, 1996). (Figure 5) Successful RotA results in the creation of a smooth vessel lumen, suitable for the successful performance of balloon angioplasty and stenting at the site of the lesion (Ellis et al, 1994).

The findings of the various studies have created some general guiding rules for the optimized use of RotA (Brown et al, 1997; Reifart et al, 1997; Whitlow et al, 2001; Dill et al, 2000; Buchbinder et al, 2001; vom Dahl J et al, 2002; Goldberg et al, 2000):

Rotablation in the Drug Eluting Stent Era 185

A. Localised calcified longitudinal lesion of the left anterior descending artery before the

B. Restoration of vessel patency with the combination of rotational atherectomy and drug-

Fig. 6. Longitudinal calcified LAD lesion

eluting stent (white arrow).

origin of the first diagonal branch (black arrow).

Fig. 7. Unsucessful treatment of calcified LAD lesion with POBA


Fig. 5. Differential atherectomy The concept of differential atherectomy: the rotablation preferentially ablates inelastic, calcified, atherosclerotic tissue.
