This study reports the results from 3 European centers using rotary ablation with Rotablator, a device that is inserted into the coronary artery and removes atheroma by grinding it into millions of tiny fragments. Rotary ablation was performed in 129 patients. Primary success (reduction in percent luminal narrowing greater than 20%, residual stenosis less than 50%, without complications) was achieved by rotary angioplasty alone in 73 patients (57%). An additional 38 patients (29%) had successful adjunctive balloon angioplasty. Thus primary success was achieved in 111 patients (86%) at the end of the procedure. Acute occlusion occurred in 10 patients (7.7%). Recanalization was achieved by balloon angioplasty in 7: urgent bypass grafting was undertaken in 2. Q-wave and non-Q-wave myocardial infarction occurred in 3 and 7 patients, respectively. No deaths occurred. Follow-up angiography was performed in 74 patients (60%). Restenosis, defined as the recurrence of significant luminal narrowing (greater than 50%) occurred in 17 of 37 patients (46%) who underwent rotary ablation alone, and 11 of 37 patients (30%) who had adjunctive balloon angioplasty. The overall angiographic restenosis rate was 37.8%. In conclusion, rotary ablation is technically feasible, and relatively safe i

Bauters, C.

Bertrand, M.E. (Michel)

Dietz, U.

Erbel, R. (Raimund)

Jaegere, P.P.T. (Peter) de

Lablanche, J.M. (Jean Marc)

Meyer, J. (Jurgen)

Serruys, P.W.J.C. (Patrick)

This study reports the results from 3 European centers using rotary ablation with Rotablator, a device that is inserted into the coronary artery and removes atheroma by grinding it into millions of tiny fragments. Rotary ablation was performed in 129 patients. Primary success (reduction in percent luminal narrowing greater than 20%, residual stenosis less than 50%, without complications) was achieved by rotary angioplasty alone in 73 patients (57%). An additional 38 patients (29%) had successful adjunctive balloon angioplasty. Thus primary success was achieved in 111 patients (86%) at the end of the procedure. Acute occlusion occurred in 10 patients (7.7%). Recanalization was achieved by balloon angioplasty in 7: urgent bypass grafting was undertaken in 2. Q-wave and non-Q-wave myocardial infarction occurred in 3 and 7 patients, respectively. No deaths occurred. Follow-up angiography was performed in 74 patients (60%). Restenosis, defined as the recurrence of significant luminal narrowing (greater than 50%) occurred in 17 of 37 patients (46%) who underwent rotary ablation alone, and 11 of 37 patients (30%) who had adjunctive balloon angioplasty. The overall angiographic restenosis rate was 37.8%. In conclusion, rotary ablation is technically feasible, and relatively safe in the coronary circulation. The low primary success rate reflects the limited size of the device, which can be introduced through available guiding catheters, and limits the use of rotary ablation as a stand-alone procedure to lesions in small arteries or in distal locations. No reduction in restenosis was seen, but the role of this device combined with balloon angioplasty in larger arteries needs to be further defined

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Percutaneous Transluminal Coronary Rotary Ablation with Rotablator (European Experience) Michel E. Bertrand, MD, Jean M. Lablanche, MD, Fabrice Leroy, MD, Christophe Bauters, MD, Peter De Jaegere, MD, Patrick W. Serruys, MD, PhD, Jurgen Meyer, MD, Ulrich Dietz, MD, and Raimund Erbel, MD This study reports the results from 3 European centers using rotary ablation with RotabiatorTM, a device that is inserted into the coronary artery and removes atheroma by grinding it into millions of tiny fragments. Rotary abtation was performed in 129 patients. Primary success (reduction in percent iuminai narrowing >20%, restduai steno- sis <SO%, without complications) was achieved by rotary angiopiasty alone in 73 patients (57%). An additional 38 patients (29%) had successful ad- junctive balloon angiopiasty. Thus primary suc- cess was achieved in 111 patients (86%) at the end of the procedure. Acute occlusion occurred in 10 patients (7.7%). Recanaiization was achieved by balloon angiopiasty in 7: urgent bypass graft- ing was undertaken in 2. Q-wave and non-Q-wave myocardiai infarction occurred in 3 and 7 pa- tients, respectively. No deaths occurred. Foilow- up angiography was performed in 74 patients (60%). Restenosis, defined as the recurrence of significant luminal narrowing (>50%) occurred in 17 of 37 patients (46%) who underwent rotary ab- lation alone, and 11 of 37 patients (30%) who had adjunctive balloon angiopiasty. The overall angio- graphic restenosis rate was 37.80/o. in conclusion, rotary ablation is technically feasible, and reiative- iy safe in the coronary circulation. The low pri- mary success rate reflects the limited size of the device, which can be introduced through available guiding catheters, and limits the use of rotary ab- lation as a stand-alone procedure to lesions in small arteries or in distal locations. No reduction in restenosis was seen, but the role of this device combined with balloon angiopiasty in larger arter- ies needs to be further defined. (AmJ Cardioi 1992;69:47O474) From the Division of Cardiology B, Hbpital Cardiologique, University of Lille, Lille, France; Catheterisation Laboratory, Thorax Center, Rotterdam, the Netherlands; and Second Medical Clinic, Johannes Gutenberg University, Mainz, Germany. Manuscript received June 21, 1991; revised manuscript received and accepted October 21, 1991. Address for reprints: Michel E. Bertrand, MD, Service de Cardiolo- gie B, et Hemodynamique Hapita Cardiologique, Boulevard u Profes- seur J Leclercq, 59037 Lille, Cedex, France. T he original description of percutaneous translu- minal coronary angioplasty has led to major changes in the clinical practice of cardiology, and has stimulated innovative xpression i  research. In the last 5 years, significant improvements have been made in the initial balloon catheter system described by Gruentzig et al.’ However, the major problem of reste- nosis, which occurs in up to 40% of cases after an ini- tially successful procedure,* and continuing technical difficulties in dealing with certain types of lesion (par- ticularly those that are calcified or in distal locations) have stimulated research into alternative methods of dealing with atheromatous coronary obstructions. One such technique, coronary atherectomy, has been devel- oped to produce an improvement in lumen diameter by direct mechanical removal of atherosclerotic material from the vessel wall in situ. Several techniques for this purpose have been described including directional (or excisional) atherectomy, transluminal extraction ather- ectomy, and high speed rotary ablation. In this study, we present he results obtained in 3 European centers using high-speed rotary ablation with RotablatoP. METHOD5 The Rotablator (Heart Technology, Inc., Bellvue, Washington) consists of an abrasive tip (Figure 1) welded to a long flexible drive shaft tracking along a central flexible guidewire. The abrasive tip is an ellipti- cally shaped burr, manufactured in various sizes (from 1 .O mm to 2.75 mm in diameter), whose distal portion is coated with diamond chips 30 to 50 p in diameter. Ro- tational energy is transmitted by a disposable com- pressed air motor that drives the flexible helical shaft at very high speeds (up to 190,000 rpm). The number of revolutions per minute is measured by a fiberoptic light probe and displayed on a control panel. The speed of rotation is controlled by the air pressure, which is itself controlled by the operator using a foot pedal. During rotation, a small volume of sterile saline solution irri- gates the catheter sheath to lubricate and cool the rotat- ing parts. The burr and the drive shaft move freely over a central coaxial guide wire (0.009 inch in diameter), with a flexible radioopaque platinum distal part (20 mm long), which does not rotate with the burr during abra- sion. This central guidewire can be controlled and moved with a pin vise. The wire and the abrasive tip can be advanced independently, which allows the wire to be placed in a safe distal location before the burr is ad- vanced into the diseased artery. 470 THE AMERICAN JOURNAL OF CARDIOLOGY VOLUME 69 FEBRUARY 15, 1992 Protoeolr All patients received nifedipine (60 mg orally in 3 divided doses) and aspirin (500 mg orally) the day before the procedure. Chlorodiazepate (50 mg intravenously) was given on the day of the procedure as premeditation. A sheath (9Fr) was inserted into the femoral artery under local anesthesia nd a standard 9Fr guiding catheter was advanced to the ostium of the coronary artery. After intracoronary injection of isosor- bide dinitrate (2 mg), a baseline angiogram was record- ed in 3 projections, and heparin (10,000 IU) was given intravenously. Rotary ablation began with the placement of the small guidewire across the lesion to a safe distal vessel location, sometimes guided by a 3Fr infusion catheter which was positioned first. The burr and the drive shaft were then manually advanced over the guidewire to the site of the lesion, and rotation was begun. When an ade- quate speed of rotation (>lSO,OOO rpm) had been achieved, the abrasive tip was advanced gently over the guidewire. If resistance was encountered the tip was successively pulled back and advanced to maintain a high speed of rotation. Several slow passes were usually required to achieve maximal plaque removal. Typical results of the procedure are shown in Figures 2 and 3. The angiographic results of the patients tudied in Lille and Rotterdam were assessed by computerized quanti- tative coronary angiography (as described later). When the residual stenosis after atherectomy remained signifi- cant (>50%), an additional percutaneous balloon angio plasty was performed. Patients were discharged with ni- fedipine (60 mg/day) and aspirin (100 to 500 mg/day) and underwent repeat coronary angiography 3 to 6 months after the procedure. The study protocol was ap proved by the local Research Ethics Committee, and written informed consent was obtained from all pa- tients. Primary success of rotary ablation was defined as a significant reduction (>20%) of stenosis with residual stenosis <50% without complications during hospital- ization. Restenosis was defined as the recurrence of a significant narrowing (reduction of luminal diameter >50%). Study population: One hundred twenty-nine patients (107 men and 22 women, mean age 57 f 8 years, range 33 to 68) underwent rotary ablation. Sixty-five patients were treated in Lille, France, 54 in Mainz, Germany, and 10 in Rotterdam, the Netherlands. Clinical characteristics: Most of the patients (n = 68 or 53%) had severe (Canadian Cardiovascular Grade 3) stable effort angina, 13 or 10% had angina on effort and at rest, 15 (11.5%) had unstable angina, 15 com- plained of angina at rest, and only 6 (5%) had atypical chest pain; finally, 12 patients had no chest pain. flGURE1.GistalpartoftheRotabWor withtheburr. CORONARY ROTARY ABLATION 471 TABLE I Quantitative Coronary Analysis After Rotary Ablation Rotary Ablation After Rotary Ablation Before After + Balloon Rotary ablation (mm) 0.72 f 0.30 1.46 2 0.43 Stand alone proce- 73 + 12 42 t 13* dure (%I Rotary ablation + balloon angioplasty mm 0.49 + 0.37 1.14 k 0.36* 2.2 -+ 0.46* % 80 k 12 61 * 13 31 f 9* *p <O.Ol. Quantitative coronary angiography: coronary ar- dilated vessel to the narrowest point of the stenosis on teriograms were analyzed with use of a computer- ized automatic-analysis ystem (Computerized Assisted Evaluation of Stenosis and Restenosis). The tine film was projected with a Tagarno projector and the end- diastolic frame selected for analysis was scanned with a CCD JVC video camera. The signal produced by the video camera was digitized and processed with a soft- ware system on a 386 computer provided with an auto- matic edge-detection algorithm. The diameter of the coronary catheter was used to convert he imaging data from pixels to millimeters. The frames for analysis were chosen by a cardiologist who was not involved in the study protocol. The dilated vessel segment was defined by measuring the distance from a side branch of the l-, 2- and 3-vessel disease in 68, 25 and 7%, respective- Angiographic data: Coronary angiograms howed ly. In all patients only 1 coronary segment was treated by rotary ablation. The procedure was performed on the left anterior descending artery in 63 patients, the right coronary artery in 47 patients and the circumflex artery in the remaining 19 patients. Most of the stenoses were routine lesions: According to American Heart Associ- ation/American College of Cardiology classification, 48% of the patients had type A lesions; types B and C were observed in 36 and 16% respectively. Twenty-six lesions were calcified. the angiogram immediately before ablation. All mea- surements were performed on angiograms recorded af- ter the intracoronary injection of 2 mg of isosorbide di- nitrate. Statistical analysis: All data are expressed as mean f SD. Comparisons between vessel diameters (or per- centage reduction in luminal diameter) before rotary ablation, immediately after rotary ablation and at fol- low-up were performed with use of paired Student’s ttests. A p value <0.05 was considered statistically sig- nificant. nGURE3.R~dslstionwitha?.Smmbwrofamkl-kft~or~ ksion. Upper pane/s, before Rotablator; Lw- er pads, after Rotablator. 472 THE AMERICAN JOURNAL OF CARDIOLOGY VOLUME 69 FEBRUARY 15, 1992 RESULTS Rotary ablation was performed in 128 patients; in 1 patient the guidewire could not be passed across a very tight and tortuous stenosis. Rotary ablation as a stand- alone procedure was achieved in 88 patients; in 40 pa- tients, rotary ablation was completed by adjunctive bal- loon angioplasty because of abrupt closure in 10 and insufficient results in 30 who still had significant steno- sis after the procedure. Thus, primary success was achieved by rotary ablation alone in 73 patients (57%). This relatively low success rate was mainly the result of the small size of the channel created by rotary ablation. This was due to the limited size of the burr acceptable for guiding catheters available at the beginning. With the help of additional successful balloon angioplasty in 40 patients the overall success rate of 86% (111 of 129 patients) was at the end of the procedure. Complications: A transient (few seconds) bradycar- dia was observed early in our experience in 6 patients. In 3 patients this occurred during a procedure on the right coronary artery and may have been related to mi- croembolization of the atrioventricular nodal artery. In all subsequent treatment of the right coronary artery a pacing catheter was placed in the right ventricle before the procedure. Immediately after the procedure 8 pa- tients developed a long diffuse coronary spasm distal to the treated site, which was promptly relieved by the intracoronary injection of isosorbide dinitrate. Abrupt closure occurred during the procedure in 10 patients (7.8%): In 7, the lesion was easily recrossed with a bal- loon, 2 required rapid bypass surgery without further complications or infarction, and in 1 recanalization of the abrupt closure was not attempted because the area supplied by the vessel was relatively small (no increase in cardiac enzymes and no subsequent complications oc- curred in this particular patient). Three patients devel- oped late occlusion (at 6 hours, 24 hours and 6 days after the procedure). Myocardial infarction (Q wave in 3, non-Q-wave in 7) developed in 10 patients (7.8%). Except for these 10 patients, serial creatine kinase mea- surements never exceeded the upper normal imit. There were no deaths related to the procedure. Quantitative angiographic measurements: Before and immediately after rotary ablation, quantitative an- giographic measurements (as previously outlined) were performed in the patients studied in Lille and Rotter- dam (n = 69). The results of rotary ablation as a stand- alone procedure are outlined in Table I. The mean mini- mal lumen diameter increased from 0.72 f 0.30 mm before to 1.46 f 0.43 mm immediately after the proce- dure (p <O.OOl). The ratio minimal luminal diameter/ burr size was 0.7 f 0.25. The mean percent reduction in internal uminal diameter decreased from 73 f 12 to 42 f 13%. Where the procedure was completed by adjunc- tive balloon angioplasty the mean residual minimal di- ameter was 2.2 & 0.46 mm, and the mean residual per- cent stenosis was 31 f 990. Angiographic follow-up: Seventy-four patients un- derwent repeat coronary angiography at a mean of 4.6 months (range 3 to 6) after the procedure. The angio- graphic results at follow-up were analyzed in 2 groups of patients: group A (n = 37) underwent rotary ablation as a stand-alone procedure and group B (n = 37) under- went rotary ablation with adjunctive balloon angio- plasty. Seventeen patients (46%) in group A had typical restenosis. In group B, restenosis was observed in 29.7% of patients. For the whole group the restenosis rate was 37.8%. DISCUSSION The main mechanism of action of Rotablator is an abrasion of the occlusive material allowing restoration of lumen patency. The diamond chips on the burr re- move material in millions of tiny particles. Previous ex- perimental studies in animals, and observations made on segments of human iliac arteries treated with rotary an- gioplasty showed that the resulting arterial lumen was smooth and polished. Two major concerns have been expressed regarding the use of rotary ablation in the coronary circulation; one relates to its potential to damage adjacent nonath- eromatous tissue, the other to the size of the particles generated by the procedure. Studies in animals and in human peripheral arteries3-’ have shown that rotary ab- lation selectively removes firmer noncompliant material, while the normal elastic tissue is deflected away from the probe. This potential for selective removal of dis- eased tissue, with particular affinity for harder material such as calcium, is obviously of great clinical relevance. The removal of the endothelium may contribute to the occurrence of vasospasm which we observed in some pa- tients. However, in our patients vasospasm was usually seen 2 or 3 cm beyond the site of ablation and may have been related to vibrations transmitted to the guidewire during rotation of the burr. A similar phenomenon has been reported by Hansen5 after rotational atherectomy in a rabbit model of atheroma. No-flow phenomenon, transient bradycardia and atrioventricular blocks may be related to production of microcavitations. As a result of high velocity at the burr, surface cavitations are produced according the Bernoulli equation, and this was previously documented in experimental studies.8 The second concern relates to the size of particles created by rotary ablation. This concern has been inves- tigated in several animal models6 and in human periph- eral arteries. These observations suggest hat the debris generated by rotary ablation is usually small enough to pass safely through the capillary bed. Moreover, in 32 cases we assessed left ventricular motion before and af- ter rotary ablation and we did not observe wall motion abnormality after rotary ablation. The size of the burr used in the coronary artery is a limitation of the Rotablator. The device must be insert- ed in the coronary artery through a guiding catheter. However, even with the largest available guiding cathe- ters, the inside luminal diameter does not exceed 2.5 mm. Thus, although burrs are available in sizes up to 4.5 mm, only those <2.5 mm in diameter can be used in the coronary circulation. Moreover, the ratio residual CORONARY ROTARY ABLATION 473 minimal lumen diameter/burr diameter is only 0.7: this suggests that the “effective abrasive diameter” is inferi- or to the maximal diameter of the burr. It is very likely that at the end of abrasion, the elastic arterial wall de- flects away, allowing the passage of the device through the lesion. From these experimental observations and our early clinical experience 2 different strategies may be adopted. One approach would be to start with an intentionally undersized burr, with stepwise increments in size until an optimal result is obtained. The other would involve the use of a small burr to “debulk” the vessel, leaving a smooth residual surface, and to com- plete the procedure with conventional balloon angio- plasty but using a very low inflation pressure. The re- sults in our patients would support this second ap preach. Until further information from comparative studies and longer follow up data are available, the role of rotary ablation in the treatment of coronary disease remains to be defined. The available evidence suggests that high-speed rotary ablation appears to be most use- ful for (1) lesions in vessels of 2.2 to 2.8 mm in diame- ter, (2) lesions in distal locations, (3) calcified or non- distensible lesions, and (4) eccentric lesions. However, its use should be avoided in patients with (1) lesions in large coronary vessels (>3.7 mm), (2) lesions in vessels with angiographically apparent hrombus, and (3) le- sions in degenerated saphenous vein grafts where the atherosclerotic material is likely to be friable. REFERENCES 1. Gruentzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of cow nary artery stenosis. Percutaneous transhtminal coronary angioplasty. N Eng/ J Med 1979;301:61-68. 2. Holmes DR Jr, Vliestra RE, Smith HC, Vetrovec GW, Kent KM, Cowley MJ. Faxon DP, Gruentzig AR, Kelsey SF, Detre KM, Van Raden MJ, Mock MB. Restenosis after percutaneous transluminal coronary angioplasty: a report from the Percutaneous Transluminal Coronary Angioplasty Registry of the National Heart, Lung, and Blood Institute. Am J Cordiof 1984;53:77C-SIC. 3. Fourrier JL, Bertrand ME, Auth DC, Lablanche JM, Gommeaux A, Brune- taud JM. Percutaneous coronary rotational angioplasty in humans: preliminary report. J Am Co11 Cordial 1989;14:1278-1282. 4. Bertrand ME, Lablanche JM, Fourrier JL. Bauters C, Leroy F. Percutaneous rotary ablation. Herr 1990;15:285-287. 5. Hansen DD, Auth DC, Vrwko R, Ritchie JL. Rotational atherectomy in atherosclerotic rabbit iliac arteries. Am Heart J 1988;115:160-165. 6. Ahn SS, Auth DC, Marcus DR. Moore WS. Removal of focal atheromatous lesions by angioscopically guided high speed rotary atherectomy. J Vase Surg 1988;7:292-299. 7. Bertrand ME, Fourrier JL, Auth D. Lablanche JM, Gommeaux A. Percutane- ous coronary rotational angioplasty. In: To@ E, ed. Textbook of Interventional Cardiology. Philadelphia: WB Saunders, 1990:580-589. 8. Zotz R, Stahr P, Erbel R, Auth D, Meyer J. Analysis tit’ high-frequency rotational angioplasty-induced echo contrast. Carher Cardiouaw Diagn 1991;22: 137-144. 474 THE AMERICAN JOURNAL OF CARDIOLOGY VOLUME 69 FEBRUARY 15, 1992 

Percutaneous transluminal coronary rotary ablation with rotablator (European experience)

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Percutaneous transluminal coronary rotary ablation with rotablator (European experience)

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