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Temporal Evolution in the Indication and
Technique of Coronary Angioplasty with
Cutting-Balloon. Does Experience
Influence the Performance
of the Procedure?

Calvo Cebollero, Isabel; Galache Osuna,
José Gabriel; Sánchez Rubio Lezcano,
Juan; Salazar González,
José Javier; Alonso Francia,
Carmen; Diarte de Miguel,
José Antonio; Chopo Alcubilla,
José Miguel; Placer Peralta, Luis Javier.

Hospital Universitario Miguel Servet. Zaragoza. Spain

SUMMARY
Aims: Detecting if progressive experience in cutting balloon (CB) coronary angioplasty modified the technique or its indications.
Material and Methods: 104 patients with 117 lesions, CB treated from February 1999 to March 2001, were divided in two groups according to previous experience with the technique: less than 1 year (Group I), more than 1 year (Group II). Clinical and angiographic characteristics, lesion descriptive variables before and after the procedure and dilatation technique applied to each group were compared. Statistic test used to compare averages for quantitative variables was t-Student, and U-Mann-Whitney was the non-parametric test for the rest of the study.
Results: 46 dilated lesions registered in Group I and 71 in Group II. CB reached and dilated the lesion in 84,5 % cases within Group I and 89,1% within Group II (NS). The Table 1 below shows main differences between groups.

Conclusions: Our CB indications evolved to an increase of in-Stent restenosis, calcified and ostial lesions, without decreasing the success of the technique. Main technical modifications were the switch from single inflation technique to multiple inflation per lesion, at slightly higher maximum pressure. Further studies to analyse medium-long term repercussions of changes are needed.

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INTRODUCTION
   In 1980, during the initial stages of coronary angioplasty, Lary suggested the enlargement of the possibilities of coronary angioplasty by using coronary incision as a complement of dilatation. In 1991, Barath et al. communicated the development of cutting-balloon (CB) in experimental animals; this new device for coronary dilatation combined the dilatation mechanism with the radial incision of the coronary plate. Their initial conclusion regarding the advantages of the new device were as follows:
the cutting in the arterial media reduces the vascular tone and facilitates the dilatation of the lesion with a decreased pressure and inflation time

   The reduced damage to the artery wall should induce a lower intimal proliferation.

   The cutting-balloon technique has been used for treating different types of "de novo" or restenotic lesions, fundamentally those whose 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; lesions in small calibre vessels and in-stent restenosis

   Several retrospective studies and randomized essays have proved cutting-balloon procedure -by itself or associated with other techniques such as conventional balloon or stent- to be an upward strategy due to its simplicity, efficacy and low cost.

AIM
   To detect if the progressive experience in the performance of coronary angioplasties with cutting-balloon (CB) modified the technique or its indications

PATIENTS AND METHODS
   An overall 104 patients with 117 coronary lesions were selected for CB angioplasty at Miguel Servet University Hospital in Zaragoza (Spain) between February 1999 and March 2001. 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.

   Patients were divided into two groups depending on the experience with the technique was shorter or longer than one year (group I and II, respectively). Clinical and angiographic characteristics were compared in every case as well as descriptive variables before and after the procedure and the dilatation technique used in each group.

  The means for quantitative variables were compared via Student's t values and Mann-Whitney's U test was applied to the rest of the study.

RESULTS
   Regarding age, sex and cardiovascular risk factors, no significant differences were found between both groups, as shown in Table 1. Neither mean of treated vessels nor number of damaged vessels per patient showed differences. As far as the treated artery is concerned, no differences between both groups were registered (see Table 2).


   Only the percentage of patients treated with abciximab showed differences between the group with less than one year experience (11%) and that with longer experience (39%).

   Worth special note is the fact that the same percentage of later complications (inguinal hematoma, fistulas,...) occurred in both groups (5.1% vs. 6.2%).

   Forty-six lesions were dilated in group I and 71 in group II.

   The cutting-balloon reached and dilated the lesion in 84.5% of the cases in group I and 89.1% in group II (non significant difference -NS-). Main differences between both groups are shown in Table 3.

   Notice that statically significant differences were found in the number of CBs used per lesion (p<0.005), in the number of inflations per lesion (p<0.001) and in the percentage of in-stent restenosis lesions (p<0.05); such differences were always in favour of the group with longer experience. The named group also showed a clear tendency, although non significant, in the maximum pressure of inflation and in the type of lesions (calcificated and ostials), both with p=0.06.

DISCUSSION
   In our environment, coronary angioplasty with CB is an upward strategy with a high percentage of success in complex coronary disease and in-stent restenosis

   From the introduction of the CB device, in-stent restenosis -both focal and diffuse- is the indication with a greater development, being the number of cases in this context significantly higher during the second stage than during the first one. Worth special note is the fact that at present almost half of the CB indications are in-stent restenosis
Fibrotic lesions and those with radiologically visible calcium are more frequently treated though differences between both series are not statistically significant.

   Technically, more lesions per procedure were tackled during the final series and more devices per lesion were used, following a strategy of progressive plate dilatation similar to that used with conventional balloon -fundamentally in calcificated or curved lesions in order to decrease de possibilities of type C dissection.

   The most significant difference between both series was obtained in the number of inflations per lesions which was considerably higher in the second series. This fact influenced the treatment of long lesions in which multiple sequential dilatations were performed, completing the technique with long balloon dilatation and spot stenting of the lesion. Pressure of CB inflation resulted not significantly modified, being slightly higher in the final series.

CONCLUSIONS
   Our PTCA indications with CB have developed to a higher percentage of in-stent restenosis and ostial and calcificated lesions without decreasing the success ratio of the procedure. The most important modification of the technique consists in the substitution of the unique inflation procedure for the performance of multiple inflations per lesion with slightly higher maximum pressures.

   Middle and long run repercussion of these changes will have to be studied in due course.

 

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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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