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Safety and Efficacy of Cutting Balloon
Coronary Angioplasty in Complex Coronary
Disease and in-Stent restenosis.
Initial Experience

Calvo Cebollero, Isabel; Galache Osuna, José G.;
Sánchez-Rubio Lezcano, Juan; Alonso Francia, Carmen;
Diarte de Miguel, José A.; Salazar González, José J.;
Moreno Esteban, Eva; Placer Peralta, Luis J.

Hospital Universitario Miguel Servet, Zaragoza, Spain

SUMMARY
Introduction: Cutting Balloon (CB) is a promising technique to treat complex coronary lesions and in-Stent restenosis.
Aims: Evaluate safety and efficacy of CB coronary angioplasty for this kind of lesions in our initial series.
Material and Methods: 104 patients with 117 lesions selected for CB angioplasty between February 1999 and March 2001. Retrospective evaluation of procedure success and complications during dilatation and hospital period.
Patients age average was 66 years (39-89). 64% of them suffered multi-vessel disease. EF 0.58 ± 19.8. 42% of cases, treated lesion was in-Stent restenosis, 9.2% bifurcation, 8.1% ostial lesion, and 21.4% visible calcium. Stenosis severity 87± 15.2%, and stenosis length was 10.97mm. Dilated vessel: LDA 46%, CX 26%, RCA 18%, SVG 5.1% and LMT 1.9%. CB/ vessel diameter ratio was 1 (3.13/3.17). Average inflates per lesion was 2 (1- 7) and inflation pressure was 8.36 ± 2.2 atm. Average final stenosis was 5.7 ± 11,3%.
Results: The procedure success was 85%. A stent, elective in 83% of cases, was implanted in 56% of lesions. Conventional ballooning was also used in 39% of cases.
Nine coronary complications were registered: 9 dissections (one occlusive, solved by stenting). No other complications, such as perforation, distal embolisation or slow flow. Until the hospital discharge one myocardial Infarction due to sub-acute occlusion which was solved by re-dilatation, 4 vascular complications, 3 bruise and one A-V fistula.
Conclusions: CB coronary angioplasty is a safety and effective technique to treat patients with complex coronary disease and in-Stent restenosis.

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INTRODUCTION
   Coronary angioplasty is a widely accepted method for the treatment of heart disease; however, coronary dilatation by conventional ballooning can cause uncontrolled damage to vessels, facilitate dissection and elicit a proliferative endothelial response leading to restenosis; these situations are associated to major and minor clinical events in the months immediately following performance of the percutaneous procedure.

   The implantation of coronary endoprostheses has substantially reduced the occurrence of complications during the acute phase of dilatation and also, significantly, that of restenosis. However, some lesions of special morphology or location continue to challenge interventionism. Such lesions include ostial damage and bifurcation, which are technically complex to solve and involve the risk of plate shifting; those resisting dilatation owing to fibrosis or parietal calcification, where the stent may expand inadequately or unevenly; elongated lesions associated to long stented segments and a high rate of restenosis; and in-stent restenosis, the treatment of choice for which remains uncertain.

   The cutting balloon (CB) technique, which involves incision and dilatation of the heart plate, is a promising choice for treating the above-mentioned lesions. It results in minimal damage to vessel walls as it uses 3-5 microblades 0.010 inches in size that are aligned lengthwise on the balloon surface; as the CB is inflated, the microblades expand radially and cut the plate, thereby facilitating dilatation of the lesion with a decreased pressure and inflation time, and potentially reducing damage to the artery wall; this in turn should decrease the incidence of complications following coronary dilatation.

AIM
   To assess the safety and efficacy of cutting balloon (CB) coronary angioplasty in patients with complex coronary disease and in-stent restenosis in our initial series.

PATIENTS AND METHODS
   An overall 104 patients with 117 lesions were selected for CB angioplasty at the A. Miguel Servet-University Hospital in Zaragoza (Spain). The procedure was always performed using the femoral way and the Judkins technique; the guiding catheter was of the 6F or 8F type, at the operator's discretion.

   The CBs used were 10 mm long and wide enough to ensure a 1:1 balloon/vessel ratio except in those cases involving in-stent restenosis, where the diameter of the cutting balloon was 0.25 mm greater than the previously implanted stent, and in lesions involving visible parietal calcification, where the CB diameter was slightly smaller than that of the vessel.

   With focal lesions (< 10 mm), the balloon was inflated once at 8 atm for 60 s; performing further dilatations or altering the inflation pressure or time in order to ensure optimal results was left to the operator's discretion. With elongated lesions and diffuse in-stent restenosis, the balloon was inflated several times sequentially during the procedure.

   When the results of the CB procedure were judged sub-optimal, conventional ballooning dilatation at a low pressure or stent implantation were performed.

   Dilatation variables, the success of the process and its coronary and non-coronary complications during dilatation and hospital stay, are retrospectively examined. Data are expressed as percentages and means plus their standard deviations.

RESULTS
   Of the 104 patients studied, 98 were males and 6 females. The average patient age was 66 years (range 39-89). Sixty percent of the patients were hypertensive, 51% had dislypidemia and 39% were smokers. Forty percent had had a prior infarction and 13.5% aortocoronary bypass surgery. Sixty-four percent had a significant multivessel disease. The average number of affected vessels was 2 but 35% of the patients had all three territories damaged. The average EF was 0.58 ± 19.8.

   The most frequent indications for CB angioplasty (Figure 1) were in-stent restenosis (42%), rigid lesion by parietal calcium (21.4%) and elongated lesion (10.25%); the remainder were evenly distributed among ostial lesions (8.1%), bifurcations (9.2%) and eccentric lesions where cutting was used to optimize the subsequent deployment of the electively indicated stent.

   Abciximab was used in 26% of cases.

   The dilated vessel was DA in 46%, CX in 26%, CD in 18%, saphena grafting in 5.1% and TCI in 1.9% of cases. Most of the lesions were located in proximal segments. Figure 2 shows the distribution of lesions according to segment.

   The average diameter of the CB dilated vessel at the stenosis level was 3.09 ± 0.65 mm and the average severity of the dilated stenosis 87 ± 15.2. The average CB/vessel diameter ratio was 1. Finally, the average number of inflations per lesion was 2 ( range 1-7) and the average inflation pressure 8.36 ± 2.2 atm.

   Use of the cutting balloon was deemed successful (i.e. the balloon reached the lesion, crossed it and dilated to an extent that the residual lesion was less than 30% of the original) in 100 of the 117 lesions treated (85% of cases). In the remaining 17 lesions (15% of cases), the CB failed to reach the lesion in 9 cases, to cross it in 6 and to provide acceptable results in 1-where conventional ballooning proved effective but the CB could not dilate the calcified lesion, located in the distal CD, and yielded sub-optimal results despite the many inflations applied using a conventional balloon at pressures up to 20 atm.

   Of the 9 cases where the cutting balloon failed to reach the lesion, 6 were located in middle segments of the heart vessel. In all cases, the lesion exhibited visible parietal calcium and the segment of the vessel adjacent to the lesion was also calcified. Only in one case was in-stent restenosis found to be indicated.

   Of the 6 lesions that could not be crossed by the CB, 4 were calcified and 2 were of diffuse in-stent restenosis. In those cases where the lesion was so severe that the CB could not cross it, it was dilated with a 1.5 or 2 mm balloon.

   Fifty-six percent of the lesions were treated with a stent, which was the treatment of choice in 83% of cases. In 39%, the final result was optimized by using conventional ballooning.

   The average stenosis at the end of the procedure was 5.7 ± 11.3%.

   An overall 9 coronary complications were encountered, namely: 9 dissections, one of which was occlusive and solved with a stent implant. There were no other complications such as perforation, distal embolization or slow flow.

   There was no major coronary event (death, infarction or the need for heart surgery or a new percutaneous vascularization) between performance of the procedure and discharge from hospital in those cases where CB dilatation was successful.

   No death or need for urgent surgery arose in those cases where CB dilatation failed. The sole lesion where the CB procedure failed led to infarction by occlusion at 48 h (Table 1). There were 4 vascular complications at the femoral puncture level, 3 bruises and 1 arteriovenous fistula that required surgery.

DISCUSSION
   Cutting balloon coronary angioplasty proved effective in a group of patients with complex coronary disease, most of elderly age and having a multivessel disease and lesions that are technically difficult to solve with conventional angioplasty. The results were good even for the initial patient series used to test the procedure.

   Cutting balloon atherectomy appears to be especially useful for ostial lesions and bifurcations, particularly those affecting the ostium of the secondary vessel (diagonal and marginal ostial lesions) as it reduces the risk of the plate being shifted between vessels, which usually complicates dilatation of the lesion and requires the use of lengthy procedures and the previously unplanned implantation of a stent. CB dilatation of the ostium of the secondary branch is a straightforward, expeditious, affordable procedure that allows dispensing with stent implantation in many cases.
Fibrotic lesions-even those where some visible calcium is present on the vessel wall at the lesion level-can be more readily dilated with a CB. The mechanism of action, which involves radial incision of the plate by the microblades on the balloon surface, releases circular stress on the plate and allows the lesion to be dilated by using lower pressures and less time, thereby providing a more favourable bed for the subsequent implantation of a stent. However, especially rigid or calcified lesions can be dilated even with the CB. The sole case in our series where the CB procedure failed to provide adequate dilatation was an undilatable lesion located in the distal CD.

   In our environment, the CB technique has become the method of choice for treating in-stent restenosis on account of its superior performance relative to conventional ballooning, its operational simplicity and its low cost relative to alternative treatments. The success rate for our patient sub-group was 92% and hence significantly higher than the overall rate (85%).

   However, the technical characteristics of the CB (viz. the profiles of the balloon and catheter body, thrust and maneuverability) place it at a disadvantage relative to conventional balloon angioplasty. Progress of the CD towards the lesion requires stronger support (frequently the use of a guiding catheter to provide better support or deeper intubations of the coronary) and greater technical skill (especially when the vessel adjacent to the lesion is rigid or tortuous, or contains parietal calcium). The cases in our series where the CB could not reach the lesion were of this type.

   Worth special note is the absence of acute coronary events in the patients where the CB procedure was successful and also the small number of complications in the series as a whole.

CONCLUSIONS
   Cutting balloon coronary angioplasty is a safe, effective technique for treating patients with a complex coronary disease and in-stent restenosis.

 

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2nd Virtual Congress of Cardiology

Dr. Florencio Garófalo
Steering Committee
President
Dr. Raúl Bretal
Scientific Committee
President
Dr. Armando Pacher
Technical Committee - CETIFAC
President
fgaro@fac.org.ar
fgaro@satlink.com
rbretal@fac.org.ar
rbretal@netverk.com.ar
apacher@fac.org.ar
apacher@satlink.com

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