**5. RotA contradictions**

 Coronary dissection, severe thrombosis and severe tortuosity are general contradictions of the method. Also RotA is relatively contraindicated in vein grafts due to the increased risk of dissection and distal embolization.

Fig. 11. Calcified chronic total occlusion of a RCA A. Guide Wire insertion. B. Three different catheters: JR4, AL1, H-STICK. C. Inability to cross CTO with eight different balloons (diameters from 1,5 – 0,85 mm). D. Rotawire crosses the lesion. E. Rotational atherectomy with 1.25 mm burr. F. DES deployment

### **6. RotA in DES era**

188 Coronary Interventions

Wire bias can occur in tortuous vessels, increasing the risk of perforation.

 Coronary dissection, severe thrombosis and severe tortuosity are general contradictions of the method. Also RotA is relatively contraindicated in vein grafts due to the increased risk

A. Guide Wire insertion. B. Three different catheters: JR4, AL1, H-STICK. C. Inability to cross CTO with eight different balloons (diameters from 1,5 – 0,85 mm). D. Rotawire crosses

the lesion. E. Rotational atherectomy with 1.25 mm burr. F. DES deployment

Fig. 10. Wire bias

**5. RotA contradictions** 

of dissection and distal embolization.

Fig. 11. Calcified chronic total occlusion of a RCA

 RotA followed by balloon angioplasty does not improve the rates of restenosis compared to direct balloon angioplasty, leading to high rates of restenosis and need for TLR—in up to 40% of cases (Reifart et al, 1997). RotA + balloon angioplasty strategy is better for the prevention of restenosis in small coronary vessels compared to balloon angioplasty alone (Mauri et al, 2003). BMS implantation after RotA has a high success rate, with an acceptable incidence of complications and a clearly lower incidence of angiographic restenosis compared to plain angioplasty, but the restenosis rate and need for TLR remain high, at 22.5% according to one previous study (Moussa et al, 1997).

Rotablation in the Drug Eluting Stent Era 191

The combination of RotA + DES is an integrated, effective and safe method of treating HCCL. The wide use of DES may cause a renaissance of RotA and its return to daily use in the catheterization laboratory, after its decline a decade ago when it failed to show better long-term results after angioplasty. In the future, randomised studies will be needed to

Benezet, J.; Díaz de la Llera, LS; Cubero, J.M.; Villa, M.; Fernández-Quero, M.; Sánchez-

Brown, D.L.; George, C.J.; Steenkiste, A.R.; Cowley MJ, Leon, M.B.; Cleman, M.W.; Moses,

Buchbinder, M. (2001) For the SPORT Clinical Trial Investigators. Abstract presentations at

Cavusoglu, E.; Kini, A.S.; Marmur, J.D.; Sharma, S.K. (2004) Current status of rotational

Clavijo, L.C.; Steinberg, D.H.; Torguson, R.; Kuchulakanti, P.K.; Chu, W.W.; Fournadjiev, J.;

Cutlip, D.E.; Chauhan, M.S.; Baim, D.S.; Ho, K.K.; Popma, J.J.; Carrozza, J.P.; Cohen, D.J.;

multicenter clinical trials. *J Am Coll Cardiol*, Vol. 18, No. 40(12), pp. 2082-208. Dardas, P.; Mezilis, N.; Ninios, V.; Theofilogiannakos, E.K.; Tsikaderis, D.; Tsotsolis, N.

Dill, T.; Dietz, U.; Hamm, C.W.; Küchler, R.; Rupprecht, H.J.; Haude, M.; Cyran, J.; Ozbek,

Ellis, S.G.; Popma, J.J.; Buchbinder, M.; Franco, I.; Leon, M.B.; Kent, K.M.; Pichard, A.D.;

Fischman, D.L.; Leon, M.B.; Baim, D.S.; Schatz, R.A.; Savage, M.P.; Penn, I.; Detre, K.; Veltri,

Satler, L.F.; Kent, K.M.; Suddath, W.O.; Waksman, R.; Pichard, A.D. (2006) Sirolimus-eluting stents and calcified coronary lesions: clinical outcomes of patients treated with and without rotational atherectomy. *Catheterization Cardiovascular* 

Kuntz, R.E. (2002) Clinical restenosis after coronary stenting: perspectives from

Kolettas, A.; Nikoloudakis, N.; Pitsis, A.A. (2011) ECMO as a bridge to high-risk

C.; Kuck, K.H.; Berger, J.; Erbel, R. (2000) A randomized comparison of balloon angioplasty versus rotational atherectomy in complex coronary lesions (COBRA

Satler, L.F.; Topol, E.J.; Whitlow, P.L. (1994) Relation of clinical presentation, stenosis morphology, and operator technique to the procedural results of rotational atherectomy and rotational atherectomy-facilitated angioplasty. *Circulation*, Vol. 89,

L.; Ricci, D.; Nobuyoshi M.. (1994) A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. *N Engl J Med*, Vol. 25, No 331(8), pp. 496-501.

atherectomy. *Catheter Cardiovasc Interv*, Vol. 62, No. 4, pp. 485–498.

rotablation of heavily calcified coronary arteries. *Herz* 2011, July 7.

González, A. (2011) A Drug-eluting stents following rotational atherectomy for heavily calcified coronary lesions: long-term clinical outcomes. *J Invasive Cardiol*,

J.W.; King, S.B. 3rd; Carrozza, J.P.; Holmes, D.R.; Burkhard-Meier, C.; Popma, J.J.; Brinker, J.A.; Buchbinder, M. (1997) 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*, Vol. 80, No. 10A, pp. 60K-67K.

**7. Conclusion** 

**8. References** 

confirm the above results.

TCT 2001.

No. 2, pp. 882-892

Vol. 23, No. 1, pp. 28-32.

*Interventions*, Vol. 68, No. 6, pp. 873-878.

study). *Eur Heart J*, Vol. 21, No. 21, pp. 1759-1766.

DES reduce neointimal hyperplasia and are safer and more effective than BMS in the treatment of stable coronary lesions (Stone et al, 2007; Mauri et al, 2007). However, DES in HCCL presents a technical difficulty of stent implantation and deployment. Calcification of the lesion is already known to have a negative impact on stent deployment (MacIsaac et al, 1995). Disruption of the stent's polymer coating during forceful deployment and unsatisfactory drug elution because of extreme calcification of the lesion are the main reasons for the unsuccessful deployment and implantation of stents in HCCL. Indeed, the rates of MACE and the need for TLR were significantly higher in patients with calcified as opposed to non-calcified lesions that were treated with DES implantation (Kawaguchi et al, 2008). RotA + DES approach had better clinical and angiographic results over a 9-month follow up compared to RotA + BMS in the treatment of patients with HCCL (Khattab et al, 2007). The results from patients treated with RotA + BMS with those from a group treated with RotA + DES and another group treated with DES without RotA shows that the use of DES reduced the incidence of MACE in patients who underwent RotA, mainly because of a significant reduction in the need for TLR (Rao et al, 2006). A study compared two groups of patients with HCCL who were treated with DES, where RotA was necessary in the first group but not in the second. There was no significant difference between the groups as regards in-hospital complications or clinical outcomes (Clavijo et al, 2006). A previous study of ours showed that the therapeutic strategy of RotA + DES was effective in treating HCCL as regards both the clinical outcome and the angiographic result (Mezilis et al, 2010). The mortality and MACE rates were very low (3.3% and 11.3%, respectively) over a mean follow up of >36 months. No immediate complications related to the angioplasty were recorded, while in previous studies the incidence of such complications was from 4% to 7%. A 2-burr technique was used with a view to limiting the occurrence of the no-reflow phenomenon. Initially, a small burr was used (1.25 mm), followed by a larger burr depending on the size of the vessel. Whether this gradual approach contributed to limiting the immediate complications and to the low rate of stent thrombosis will need further investigation. Another study (Schwartz et al, 2011) reported a slightly higher rate of MACE (15.8%) and mortality (4.2%). However, in this study the authors did not describe the technique they used (i.e. burrs at one or more stages).

A recent study (Benezet et al, 2011) compared the angiographic and procedural success rates of three therapeutic strategies in patients with HCCL: RotA + only balloon angioplasty, RotA + BMS and RotA + DES. In unadjusted analysis, procedural success appears high with subsequent stent placement (DES or BMS) versus RA alone (96.4% for DES versus 95% for BMS versus 63% for no stent). However, 1 in 4 cases were not candidates for stent placement, due to reference vessel diameter < 2.25, inability to deliver DES, or desire to avert clopidogrel therapy, and the lower procedural success rate in this population should be considered prior to embarking on Rota. This rate of unsuccessful stent placement is much higher than in previous studies. Another recent study (Pagnotta et al, 2010) confirms the safety and effectiveness of Rota + DES strategy to tackle HCCL with good long-term clinical outcomes. Although the radial approach was used in 37.3% of cases, the procedure was successful in 97% of cases; this rate of success is similar to previous studies. Rotablation, when used in very high risk subsets combined with the use of short term LVADs was also proved to be efficient (Figure 12) (Dardas et al, 2011).

#### **7. Conclusion**

190 Coronary Interventions

DES reduce neointimal hyperplasia and are safer and more effective than BMS in the treatment of stable coronary lesions (Stone et al, 2007; Mauri et al, 2007). However, DES in HCCL presents a technical difficulty of stent implantation and deployment. Calcification of the lesion is already known to have a negative impact on stent deployment (MacIsaac et al, 1995). Disruption of the stent's polymer coating during forceful deployment and unsatisfactory drug elution because of extreme calcification of the lesion are the main reasons for the unsuccessful deployment and implantation of stents in HCCL. Indeed, the rates of MACE and the need for TLR were significantly higher in patients with calcified as opposed to non-calcified lesions that were treated with DES implantation (Kawaguchi et al, 2008). RotA + DES approach had better clinical and angiographic results over a 9-month follow up compared to RotA + BMS in the treatment of patients with HCCL (Khattab et al, 2007). The results from patients treated with RotA + BMS with those from a group treated with RotA + DES and another group treated with DES without RotA shows that the use of DES reduced the incidence of MACE in patients who underwent RotA, mainly because of a significant reduction in the need for TLR (Rao et al, 2006). A study compared two groups of patients with HCCL who were treated with DES, where RotA was necessary in the first group but not in the second. There was no significant difference between the groups as regards in-hospital complications or clinical outcomes (Clavijo et al, 2006). A previous study of ours showed that the therapeutic strategy of RotA + DES was effective in treating HCCL as regards both the clinical outcome and the angiographic result (Mezilis et al, 2010). The mortality and MACE rates were very low (3.3% and 11.3%, respectively) over a mean follow up of >36 months. No immediate complications related to the angioplasty were recorded, while in previous studies the incidence of such complications was from 4% to 7%. A 2-burr technique was used with a view to limiting the occurrence of the no-reflow phenomenon. Initially, a small burr was used (1.25 mm), followed by a larger burr depending on the size of the vessel. Whether this gradual approach contributed to limiting the immediate complications and to the low rate of stent thrombosis will need further investigation. Another study (Schwartz et al, 2011) reported a slightly higher rate of MACE (15.8%) and mortality (4.2%). However, in this study the authors did not describe the technique they used (i.e. burrs at one or more

A recent study (Benezet et al, 2011) compared the angiographic and procedural success rates of three therapeutic strategies in patients with HCCL: RotA + only balloon angioplasty, RotA + BMS and RotA + DES. In unadjusted analysis, procedural success appears high with subsequent stent placement (DES or BMS) versus RA alone (96.4% for DES versus 95% for BMS versus 63% for no stent). However, 1 in 4 cases were not candidates for stent placement, due to reference vessel diameter < 2.25, inability to deliver DES, or desire to avert clopidogrel therapy, and the lower procedural success rate in this population should be considered prior to embarking on Rota. This rate of unsuccessful stent placement is much higher than in previous studies. Another recent study (Pagnotta et al, 2010) confirms the safety and effectiveness of Rota + DES strategy to tackle HCCL with good long-term clinical outcomes. Although the radial approach was used in 37.3% of cases, the procedure was successful in 97% of cases; this rate of success is similar to previous studies. Rotablation, when used in very high risk subsets combined with the use of short term LVADs was also

proved to be efficient (Figure 12) (Dardas et al, 2011).

stages).

The combination of RotA + DES is an integrated, effective and safe method of treating HCCL. The wide use of DES may cause a renaissance of RotA and its return to daily use in the catheterization laboratory, after its decline a decade ago when it failed to show better long-term results after angioplasty. In the future, randomised studies will be needed to confirm the above results.

#### **8. References**


Rotablation in the Drug Eluting Stent Era 193

Moses, J.W.; Carlier, S.; Moussa, I. (2004) Lesion preparation prior to stenting. *Rev Cardiovasc* 

Moussa, I.; Di Mario, C.; Moses, J.; Reimers, B.; Di Francesco, L.; Martini, G.; Tobis, J.;

Pagnotta, P.; Briguori, C.; Mango, R.; Visconti, G.; Focaccio, A.; Belli, G.; Presbitero, P. (2010)

Rankin, J.M.; Spinelli, J.J.; Carere, R.G.; Ricci, D.R.; Penn, I.M.; Hilton, J.D.; Henderson, M.A.;

Reifart, N.; Vandormael, M.; Krajcar, M.; Göhring, S.; Preuslerm W,; Schwarz, F.; Störger, H.;

Schwartz, B.G.; Mayeda, G.S.; Economides, C.; Kloner, R.A.; Shavelle, D.M.; Burstein, S.

Serruys, P.W.; de Jaegere, P.; Kiemeneij, F.; Macaya, C.; Rutsch, W.; Heyndrickx, G.;

Stone, G.W.; Ellis, S.G.; Cox, D.A.; Hermiller, J.; O'Shaughnessy, C.; Mann, J.T.; Turco, M.;

Stone, G.W.; Moses, J.W.; Ellis, S.G.; Schofer, J.; Dawkins, K.D.; Morice, M.C.; Colombo, A.;

vom Dahl, J.; Dietz, U.; Haager, P.K.; Silber, S.; Niccoli, L.; Buettner, H.J.; Schiele, F.; Thomas,

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Hayden, R.I.; Buller, C.E.. (1999) Improved clinical outcome after widespread use of coronary-artery stenting in Canada. *N Engl J Med*, Vol. 341, No. 26, pp. 1957-1965. Rao, S.V.; Honeycutt, E.; Kandzari, D. (2006) Clinical outcomes with drug-eluting stents following atheroablation therapies. *J Invasive Crdiol*, Vol. 18, No. 9, pp. 393-396. Reisman, M. (1996) Technique and strategy of rotational atherectomy. *Cathet Cardiovasc* 

Hofmann, M.; Klöpper, J.; Müller, S.;, Haase, J. (1997) Randomized comparison of angioplasty of complex coronary lesions at a single center. Excimer Laser, Rotational Atherectomy, and Balloon Angioplasty Comparison (ERBAC) Study.

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Emanuelsson, H.; Marco, J.; Legrand, V.; Materne, P.; et al. (1994) A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. *N Engl J Med*, Vol. 331, No. 8, pp.

Caputo, R.; Bergin, P.; Greenberg, J.; Popma, J.J.; Russell, M.E. TAXUS-IV Investigators. (2004) A polymer-based, paclitaxel-eluting stent in patients with

Schampaert, E.; Grube, E.; Kirtane, A.J.; Cutlip, D.E.; Fahy, M.; Pocock, S.J.; Mehran, R.; Leon, M.B. (2007) Safety and efficacy of sirolimus- and paclitaxel-eluting

M.; Commeau, P.; Ramsdale, D.R.; Garcia, E.; Hamm, C.W.; Hoffmann, R.; Reineke, T.; Klues, H.G. (2002) 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* Vol. 105, No. 5, pp. 583-588. Warth, D.C.; Leon, M.B.; O'Neill, W.; Zacca, N.; Polissar, N.L.; Buchbinder, M. (1994)

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**10** 

Ulf Nyman *Lund University* 

*Sweden* 

**Contrast Medium-Induced Nephropathy (CIN)** 

**Strategies to Reduce Contrast Medium Doses** 

Radiographic iodine contrast media (I-CM) has been recognized as the third leading cause of hospital-acquired renal insufficiency or the most common cause among pharmaceutical agents (Nash et al., 2002) with an overall incidence of contrast medium-induced nephropathy (CIN) of 1-2% following percutaneous coronary angiography (PCA) and interventions (PCI) (Mehran & Nikolsky, 2006). The presence of multiple CIN risk factors or high-risk clinical scenarios may create a substantial risk of CIN (≈50%), acute renal failure (≈15%) requiring dialysis and an increased morbidity and mortality (Marenzi et al., 2004; McCullough et al., 2006a, 2006b). At the same time it has been argued that the risk of CIN is lower following IV administration of CM in connection with computed tomography (CT) than after IA injections during cardiac procedures (Davidson et al., 2006; Katzberg & Barrett, 2007; Katzberg & Newhouse, 2010), though there exist no comparative studies based on

Reliable prediction of pre-procedural renal function, identification of CIN risk factors, institution of adequate prophylactic regimens and to modify examination technique to reduce CM-dose are crucial to reduce patient suffering and cost since curative treatment is not available. A wide spectrum of CIN risk factors including high age, diabetes mellitus, poor cardiac function, and hemodynamic instability has been thoroughly outlined in recent

A number of prophylactic regimen studies has been performed and meta-analyzed (Kelly et al., 2008). So far no adjunctive medical pharmacological treatment has convincingly been proved to be efficacious in reducing the risk of CIN (Stacul et al., 2006) including acetylcysteine (Biondi-Zoccai et al., 2006) and hydration with sodium bicarbonate instead of saline (Zoungas et al., 2009). Haemodialysis is ineffective and hemofiltration is impractical

Thus, treating modifiable risk factors (Mehran & Nikolsky, 2006), instituting adequate intravenous volume expansion with isotonic crystalloid (Stacul et al., 2006) and withdrawal of nephrotoxic drugs, mannitol and loop diuretics are three of the four corner stones to reduce the risk of CIN (Thomsen et al., 2008a). The fourth one is to minimize the dose of the

**1. Introduction** 

matched risk factors and CM doses.

reviews (McCullough et al., 2006b; Mehran & Nikolsky, 2006).

in routine clinical practice (Stacul et al., 2006).

**Gram-Iodine/GFR Ratio to Predict CIN and** 

