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Mechanical recanalization of total coronary occlusions with the use of a new guide wire
Mechanical recanalization of total coronary occlusions with the use of a new guide wire Bernhard Reimers, MD, Nino Camassa, MD, Carlo Di Mario, MD, Tatsuro Akiyama, MD, Lucia Di Francesco, PhD, Leo Finci, MD, and Antonio Colombo, MD Milan, Italy
The mechanical approach in the recanalization of total coronary occlusions consisted of the use of a new 0.014-inch standard coronary guide wire with jointless spring coil design that improves steering characteristics and tip stiffness. In addition, a 0.014-inch soft tip wire with hydrophilic coating and low-profile 1.5 mm over-the-wire balloons were used. The first wire was used selectively in 86 patients to treat 95 total occlusions, of which 51 (54%) were older than 3 months. Unfavorable angiographic characteristics were present in 79 (83%) of 95 lesions. Overall crossing success was 71% (67 of 95 lesions). Complications were one coronary perforation with cardiac tamponade necessitating emergency bypass surgery. In conclusion, the mechanical approach with the use of the standard coronary guide wire with jointless spring coil design provides a high success rate in the recanalization of unfavorable total occlusions. (Am Heart J 1998;135:726-31.)
Percutaneous transluminal coronary angioplasty of total occlusions comprises 10% to 20% of all angioplasty procedures.1-2 The success rates of recanalization of chronic total occlusions in published series vary from 50% to 80% and depend on several variables such as the estimated age of occlusion, angiographic type of occlusion (tapered vs abrupt), presence of bridging collaterals, side branches originating at the point of occlusion, and length of the occlusion.2-6 Several recanalization devices have been proposed to improve primary success,7-16 but the best published primary success rates still remain below the success rate of stenotic lesions.2,5 In our institution the recanalization of chronic total coronary occlusion has been done on a large-scale basis since 1989 with the use of different recanalization devices. In this article we report our experience of the selective use of a new guide wire for mechanical recanalization of chronic total occlusions.
Methods Patients and angiographic characteristics From January 1996 to June 1997 percutaneous coronary interventions were performed on 1006 lesions at our institution, of which 25% (250 lesions) were total occlusions. A mechanical approach for recanalization of total occlusions that included the use of the Athlete wire (Asahi Intecc Co., LTD, Seto, Japan) was performed in 86 patients to treat 95 occlusions, representing 38% of all total occlusions treated in this period of From Columbus Hospital. Submitted May 22, 1997; accepted Oct. 22, 1997. Reprint requests: Antonio Colombo, MD, Centro Cuore Columbus, Via Buonarrotti, 48, 20145 Milano, Italy. Copyright © 1998 by Mosby, Inc. 0002-8703/98/$5.00 + 0 4/1/87785
time. The Athlete wire was selected by the operator as a primary device in 10 (11%) cases after one or more conventional wires did not cross the occlusion in 85 (89%) cases. The clinical and angiographic characteristics of patients and lesions are shown in Table I.
Device description The Athlete coronary wire is a 0.014-inch diameter wire with a tip coil design similar to that of steerable coronary standard wires currently used for coronary angioplasty (Fig. 1). This wire has optimal steering characteristics and unique stiffness, kink resistance, and pushability of the 3 cm radiopaque tip segment because of improved jointless spring coil technology (one piece core wire). The Athlete wire has different degrees of tip stiffness expressed as the weight in grams to cause the deflection of the tip (from 2 gm to 8 gm for the “super hard” version). In this study the 5 gm standard tip was used. This wire has been available in our laboratory since January 1996 and was used selectively for recanalization of total coronary occlusions when conventional wires failed to cross. The additionally used Choice PT Plus guide wire with hydrophilic coating (Scimed, Boston Scientific Corp., Maple Grove, Minn.) has minimal friction and floppy characteristics that facilitate its advancement through very narrow segments with increased resistance. In all cases lowprofile 1.5 mm over-the-wire balloons were used (Predator, Cordis Corp., Johnson & Johnson Company, Miami, Fla.; Bandit or Ranger, Scimed, Maple Grove, Minn.).
Definitions A total coronary occlusion was defined as a complete interruption of the lumen of the vessel for a certain segment with no anterograde flow through the lumen. If anterograde flow was present, it occurred through bridging collaterals. Successful crossing of the total occlusion by the guide wire was defined as the passage of the guide wire into the seg-
American Heart Journal Volume 135, Number 4
Figure 1
Jointless spring coil technology of Athlete wire.
Figure 2
Synergistic two-wire approach to chronic total occlusion of right coronary artery that was documented with angiography 8 years before. Crossing obtained with Athlete Standard wire in proximal part and with further progression into distal lumen obtained with Choice PT wire with 1.5 mm over-the-wire balloon for backup.
ment distal to the occlusion site with angiographic visualization of the true lumen of the distal vessel. A wire was considered successful in crossing the occlusion when the complete penetration of the occluded segment was accomplished entirely with that specific wire. Combined wire success was defined when more than one wire was used to cross the entire occlusion length. Angiographic success was defined as subsequent successful balloon angioplasty or other procedures able to restore a patent vessel lumen with a final residual stenosis of <30% and with a Thrombolysis in Myocardial Infarction grade 3 distal blood flow without any immediate complications such as vessel perforation, myocardial infarction, emergency surgery, or death. The angiographic morphologic characteristics of the occlusion were defined as tapered if the occluded segment ended in a funnel-shaped form, or abrupt if it ended without a funnel. Unfavorable lesion morphologic characteristics were defined as the presence of one feature known to be associated with low recanalization success: abrupt type of occlusion, presence of bridging collaterals, side branches originating at the point of occlusion, and length of the occlusion ≥15 mm. The age of chronic total occlusion was determined as the
Reimers et al. 727
Table I. Patient and lesion characteristics
Study patients Age* (yr) Male Previous myocardial infarction LV ejection fraction* (%) Lesions attempted Vessel distribution Left anterior descending Left circumflex Right coronary artery Age occlusion* (mo) <3 mo 3 mo to 1 yr ≥1 year Undetermined Bridging collaterals Abrupt occlusion Tapered occlusion Occlusion length ≥15 mm Side branches at occlusion site One or more unfavorable angiographic characteristic Contralateral collaterals
No.
Percent
86 54 ± 9 74 66 57 ± 11 95
100 86 77 100
33 29 33 18 ± 27 15 20 31 29 28 41 54 43 61 79
35 30 35 16 21 33 30 29 43 57 45 64 83
60
63
LV, Left ventricular. *Mean ± SD
time interval from the first angiogram demonstrating the occlusion. When no angiogram was available, history of myocardial infarction or prolonged chest pain with electrocardiographic changes in the territory of distribution of the occluded artery was used to date the occlusion. In the absence of clinical events the occlusion was classified as of undetermined age. The lesion length was measured from the direct vessel injection when the distal vessel was visible through bridging collaterals or with a simultaneous bilateral injection when the distal vessel was visualized only from collaterals supplied by the contralateral coronary artery. The duration of the procedure was calculated as the interval between patient arrival in the catheterization laboratory and the end of the procedure.
Recanalization procedure The target vessel was first cannulated with an 8F guiding catheter. These were Judkins curve 67%, extra backup 24%, and Amplatz curve 9%. In 47 (49%) patients simultaneous injections from a 5F or 6F diagnostic catheter in the contralateral coronary were performed to visualize the vessel distal to the total occlusion supplied by collateral flow. A bolus of 100 U/kg heparin was given at the beginning of the procedure, and activated clotting time was maintained at more than 200 seconds with repeat boluses of heparin. In all cases a 1.5 mm low-profile over-the-wire balloon was used and advanced
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728 Reimers et al.
Figure 3
Table II. Procedural data
Crossing success Athlete wire success* Combined success Athlete and Choice PT wires* Choice PT success 0.010-inch ACS Standard Laser wire success Contralateral injection Tamponade + urgent CABG Local contrast staining Procedure time, minutes† Fluoroscopy time (min) Further treatment in 67 crossed lesions Stent implantation Rotational atherectomy Directional atherectomy Laser catheter Angiographic success with TIMI 3 flow at end of procedure
Lesions
Percent
67 39 21
71 41 22
3 3 1 47 1 14 110 ± 49 44 ± 21
3 3 1 49 1 15
58 6 4 2 62
86 9 6 3 65
CABG, Coronary artery bypass graft; TIMI, thrombolysis in myocardial infarction. *Athlete wire determinant for crossing success in 60 lesions (63%). †Patient stay in the catheterization laboratory.
close to the lesion site to enhance support and to facilitate wire reshaping or exchange without losing the chosen direction and the reached position. Gentle maneuvering and steering of the wire across the occluded segment was tried until the wire penetrated the distal lumen. The maneuvers were stopped when a significant dissection jeopardizing access to the distal true lumen or vessel perforation occurred. In 10 (11%) cases the Athlete wire was used as the first wire. In 85 (89%) lesions the Athlete wire was used after one or more wires could not cross the occlusion. These were mostly (69%) floppy wires such as Choice PT and Hi Torque Floppy (ACS, Temecula, Calif.) and in 20% Intermediate or Standard wires (Hi Torque) or the Terumo Crosswire (Terumo Corp., Tokyo, Japan). In one case a Laser wire (Prima wire, Spectranetics, Colorado Springs, Colo.) was successfully used after failure with the Athlete wire and three other wires occurred. A Laser catheter was used if the balloon catheter could not cross the occlusion. In the 155 occlusions attempted in our laboratory without the Athlete wire, different floppy, intermediate, standard, and coated wires of 0.014-inch and 0.010-inch diameter have been used (Hi torque-ACS, Wizdom-Cordis, Choice PT-Scimed, Silk-USCI, Dasher-Target Therapeutics, Crosswire Terumo).
Comparison with previous results We compared the results obtained with this new approach with those of a group of patients with similar lesion characteristics previously treated at our institution with the classic guide wire approach (intermediate guide wires, standard guide wires, or both). Comparison was performed with the
Total occlusion of left anterior descending coronary artery documented with angiography 3 years before procedure. Note abrupt occlusion (arrow) with large septal side branch originating at occlusion site; after successful crossing with Athlete Standard wire. A good final result is obtained with balloon angioplasty and stent implantation, persistent at follow-up.
chi-squared analysis or Fisher’s exact test according to the number of categoric variables; p < 0.05 was considered statistically significant.
Results Overall crossing success was obtained in 67 (71%) of 95 lesions: in 39 (41%) of 95 cases with the Athlete wire, in 21 (22%) of 95 cases with the combination of Athlete and Choice PT wires, in 3 (3%) of 95 cases with the Choice PT wire, in 3 (3%) of 95 cases with the 0.010-inch ACS standard wire, and in 1 (1%) case with the combination Laser wire and Choice PT. The Athlete guide wire was determinant for successful crossing in 60 (63%) of 95 lesions (Table II). In 21 of these occlusions the Choice PT significantly helped in the progression of the Athlete wire or penetrated the last segment of the occlusion (Fig. 2). In 10 cases the Athlete wire was used as the first wire, of which 6 were successful. In these six cases a possible crossing success with a different type of wire cannot be excluded. After successful guide wire crossing was performed, balloon angioplasty was performed in all 67 lesions. Additional procedures were coronary stenting (86%), rotational atherectomy (9%), directional atherectomy (6%), and Laser catheter atherectomy (3%). Angiographic success with thrombolysis in myocardial infarction 3 flow was obtained in 63 (66%) of 95 lesions. Three illustrative cases of this series are shown in Figs. 2, 3, and 4. Major complications occurred in one (3%) patient, who had coronary perforation and cardiac tamponade and underwent emergency bypass surgery with good
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Figure 4
Reimers et al. 729
Table III. Comparison of recanalization success with the new wire approach versus standard approach New wire approach
Chronic total occlusion of left anterior descending artery (arrow) in patient with anterior myocardial infarction 8 months before. Crossing obtained with Athlete and Choice PT wire with 1.5 mm over-the-wire balloon. Angiographic follow-up shows moderate, not critical, restenosis within stented segment.
final outcome. The perforation occurred after attempted recanalization of a coronary occlusion with five different guide wires and a final attempt with the Athlete wire. Staining of contrast medium outside the vessel lumen caused by guide wire exit occurred in 14 (15%) patients and remained without clinical sequelae. A total of 25 to 50 mg protamine sulphate was given to all these 14 patients, and the procedure was interrupted in nine patients. Perforations were caused in eight cases by the Athlete wire, in five cases by the Choice PT wire, and in one case by a 0.010-inch standard wire. The mean duration of the procedure (time in the catheterization laboratory) was 110 ± 49 minutes (range 50 to 250 minutes) with a mean fluoroscopy time of 44 ± 21 minutes (range 20 to 130 minutes). Twenty-two patients had procedures on other vessels in the same session. Recanalization success of the 155 occlusions attempted without the use of the Athlete wire during the period of the study was obtained in 121 (78%) lesions including acute, subacute, and angiographically more favorable lesions.
Discussion The number of lesions reported in this series is limited, but the results are notable considering the age of many attempted occlusions and the presence of unfavorable morphologic lesion characteristics. Before the
Standard approach
Variable
No.
Percent
No.
Duration of occlusion <1 mo 1-3 mo >3 mo Unknown Abrupt morphology Length of >15 mm Bridging collaterals Overall success
7/7 6/8 35/51 19/29 32/43 30/45 18/28 67/95
100 75 69 66 74 67 64 71
65/73 67/77 49/110 63/105 119/234 123/205 9/31 151/240
Percent p Value
89 87 45 60 51 60 29 63
0.5 0.5 0.08 0.09 0.09 0.4 0.08 0.5
Athlete wire was available, many of the occlusions treated in this population would not have been attempted for revascularization in our institution because of these primary unfavorable characteristics. We compared the present data to results obtained in our laboratory before the introduction of the Athlete wire (Table III).6 At that time we analyzed 365 chronic total occlusions and found several variables that influenced primary success rate such as the operator experience (41% in the early period, 73% in the late period), duration of occlusion (<1 month 89%, >3 months 45%), and morphologic characteristics of the occlusion (tapered 83%, abrupt 51%). Crossing success for the mechanical approach with classic guide wires was 63% in the last 240 occlusions performed with improved operator experience compared with 71% in 95 occlusions with the new guide wires. When the estimated duration of the occlusion was less than 1 month, the recanalization was highly successful with either approach (100% with the new approach and 89% with the classic guide wire approach). In occlusions older than 3 months the success of the new approach was 69%, whereas the success of the classic guide wire approach was only 45%. In occlusions with unfavorable morphologic characteristics, the new approach had a success of 77%, whereas the classic guide wire approach had a success of 53% (p = 0.02). In this study characteristics such as age of occlusion, angiographic type of occlusion, presence of bridging collaterals, side branches at the occlusion site, and length of the occlusion did not affect the final crossing with the new wire approach (Table III). Present numbers, however, are too small to draw final conclusions. The success rate of recanalization of chronic total
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730 Reimers et al.
occlusions in this study must be compared with those of other published series. In a randomized study with the Magnum wire (Schneider, Bülach, Switzerland) primary recanalization success was achieved in 45%,7,8 which compares well to the 41% success of the Athlete wire alone. The 63% success rate of the combined use of the Athlete and the Choice PT wire, however, underlines the importance of a synergistic approach of more than one wire. The Terumo hydrophilic coated guide wire had a success rate of 39% to 88%,9-12 the Rotacs low-speed system had a success rate of 66%,14 the use of a vibration guide wire system had a reported success rate of 78%,15 and the Spectranetics Laser wire had 58% to 60% success rate with a 20% incidence of coronary perforation and a 1.3% incidence of cardiac tamponade.16 The Laser wire is a nonmechanical approach to occlusions and is generally used in our laboratory not as a first-line device but when mechanical wires fail. This approach is taken because reported results of the elective use of the laser wire are not superior to those of the mechanical approaches.16 An important technical element of this report is the use of 1.5 mm over-the-wire balloons. Low-profile balloons with tapered and trackable tips confer ability to support the wire up to its very distal end. They also prevent the loss of any reached position inside the occlusion, allowing the operator to remove the wire to reshape the tip or to easily exchange wires as needed to help the progression throughout the occluded segment. The use of small 1.5 mm balloons increases the probability to cross the occlusion not only with the wire but also with the balloon. Furthermore careful balloon inflations to allow visualization of distal flow, especially in the case of a short subintimal passage of the wire before reentrance into the distal lumen, appear less hazardous with smallsized balloons. In the case of acute and subacute or angiographically favorable total occlusions, however, we use normal-sized balloons to start with. A unique characteristic of the Athlete wire is the steerability, which is superior to the steerability of other available wire even when advanced inside the occluded segment. In our experience crossing a total occlusion may require at one level (mainly the proximal and distal extremity of the occlusion or the distal lumen reentrance) a wire with great stiffness and steerability and at another level (possibly within the occlusion or in the distal vessel) a wire with very low friction. The Choice PT wire has an effective complementary role in this approach. Thus it appears to be more appropriate to consider the recanalization technique presented here as
a synergistic approach with a stiff steerable wire, a floppy hydrophilic coated wire, and a low-profile over-thewire balloon. The use of the Athlete wire did not require a learning curve for an experienced operator because its major feature is the increased steerability facilitating the wire advancement in the desired direction. Another element contributing to the success and the safety of these procedures is the use of contralateral injections to visualize the distal vessel in multiple projections, direct the progression of the wire in the occluded segment toward the distal true lumen, and confirm the intraluminal position of the wire after crossing the occluded segment. Thus contralateral injections facilitate and increase the safety of recanalization procedures. The only case in which the Athlete and other mechanical wires failed and final success was achieved with the 0.018-inch Laser wire combined with the Choice PT may bring out the concept that even higher success rates in recanalizing total occlusions can be achieved with a “multidevice” approach. The 1.4 mm Laser catheter was useful in two other cases in which the balloon could not be advanced through the lesion crossed by the wire. Despite the small numbers reported in this study, we believe that these results are very encouraging and support the concept that guide wire and balloon technology can still play an important role in improving the success rate in the field of chronic total occlusions. More sophisticated and more costly approaches must be compared with this evolving “standard” tool to define the possible niche for new devices. The case of cardiac tamponade (1%) with subsequent pericardial drainage and urgent bypass surgery is a reminder of the presence of a discrete procedural risk when total occlusions are attempted. In cases in which perivessel contrast staining was present with no need for surgical intervention, the prompt use of protamine sulphate appeared to be very useful in preventing possible intrapericardial bleeding.
Conclusions With the use of the Athlete guide wire in a synergistic approach with a floppy hydrophilic wire and a low-profile balloon for mechanical recanalization of total chronic occlusions, a success rate of 71% was achieved independent of the age of the occlusion or unfavorable lesion characteristics and with a low incidence of complications. However, larger randomized studies are necessary to evaluate the role of this “new-old technology” for mechanical recanalization of chronic total occlusions.
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Reimers et al. 731
We thank Dr. Osamu Katoh (Osaka/Frankfurt), who introduced the Athlete guide wire in our institution.
References 1. Ruocco NA, Ring ME, Holubkov R, Jacobs AK, Detre KM, Faxon DP, et al. Results of coronary angioplasty of chronic total occlusion (the NHLBI 1985-86 PTCA Registry). Am J Cardiol 1992;69:69-76. 2. Puma JA, Sketch Jr MH, Tcheng JE, Harrington RA, Phillips RH, Stack RS, et al. Percutaneous revascularisation of chronic total occlusions: an overview. J Am Coll Cardiol 1995;26:1-11. 3. Flameng W, Schwartz F, Hehrlein FW. Intraoperative evaluation of the functional significance of collateral coronary vessels in patients with coronary artery disease. Am J Cardiol 1978;42:187-92. 4. Katsuragawa M, Fujiwara H, Miyamae M, Sasayama S. Histologic studies in percutaneous transluminal coronary angioplasty for chronic total occlusion: comparison of tapering and abrupt types of occlusion and short and long occluded segments. J Am Coll Cardiol 1993;21:604-11. 5. Kinoshita I, Katoh O, Nariyama J, Otsuji S, Tateyama H, Kobayashi T, et al. Coronary angioplasty of chronic total occlusions with bridging collateral vessels: immediate and follow-up outcome from a large singe-center experience. J Am Coll Cardiol 1995;26:409-15. 6. Maiello L, Colombo A, Gianrossi R, Mutinelli M-R, Bouzon R, Thomas J, et al. Coronary angioplasty of chronic occlusions: factors predictive of procedural success. Am Heart J 1992;124:581-4. 7. Meier B, Carlier M, Finci L, Nukta E, Urban P, Niederhause W. Magnum wire for balloon recanalization of chronic total occlusions. Am J Cardiol 1989;64:148-54. 8. Pande AK, Meier B, Urban P, de la Serna F, Villavcencio R, Dorsaz
9.
10.
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15. 16.
PA. Magnum/magnarail versus conventional system for recanalization of chronic total coronary occlusions: a randomised comparison. Am Heart J 1992;123:1182-6. Hosny A, Lai D, Mancherje C, Lee G. Successful recanalization using a hydrophilic-coated guidewire in total coronary occlusions after unsuccessful PTCA attempts with standard steerable guidewires. J Intervent Cardiol 1990;3:225-30. Rees MR, Sivananthan UM, Verma SP. The use of the hydrophilic Terumo glidewire in treatment of chronic coronary total occlusion. Circulation 1991;84(suppl II):II-519. Gray DF, Sivananthan UM, Verma SP, Michalis LK, Rees MR. Balloon angioplasty of totally and subtotally occluded coronary arteries: results using the hydrophilic Terumo radiofocus guidewire M (Glidewire). Cathet Cardiovasc Diagn 1993;30:293-9. Zimarino M, Rasetti G, Venarucci V, Pagliacci M. Terumo guidewire: the wire of choice for chronic total occlusion (letter). Cathet Cardiovasc Diagn 1995;34:186-8. Hamm CW, Kupper W, Kuck KH, Hofmann D, Bleifeld W. Recanalisation of chronic, totally occluded coronary arteries by new angioplasty systems. Am J Cardiol 1990;66:1459-63. Kaltenbach M, Hartmann A, Valbracht C. Procedural results and patient selection in recanalization of chronic coronary artery occlusions by low speed rotational angioplasty. Eur Heart J 1993;14:826-30. Rees MR, Michalis LK. Vibrational angioplasty in chronic total occlusions. Lancet 1993;342:999-1000. Serruys PW, Hamburger JN, Rutsch W, Mathey D, Simon R, Fleck E, et al. Recanalisation of chronic total coronary occlusion using a Laser guidewire: the European TOTAL Multicentre Surveillance Study. Eur Heart J 1996;17-A:516.
The mechanical approach in the recanalization of total coronary occlusions consisted of the use of a new 0.014-inch standard coronary guide wire with jointless spring coil design that improves steering characteristics and tip stiffness. In addition, a 0.014-inch soft tip wire with hydrophilic coating and low-profile 1.5 mm over-the-wire balloons were used. The first wire was used selectively in 86 patients to treat 95 total occlusions, of which 51 (54%) were older than 3 months. Unfavorable angiographic characteristics were present in 79 (83%) of 95 lesions. Overall crossing success was 71% (67 of 95 lesions). Complications were one coronary perforation with cardiac tamponade necessitating emergency bypass surgery. In conclusion, the mechanical approach with the use of the standard coronary guide wire with jointless spring coil design provides a high success rate in the recanalization of unfavorable total occlusions. (Am Heart J 1998;135:726-31.)
Percutaneous transluminal coronary angioplasty of total occlusions comprises 10% to 20% of all angioplasty procedures.1-2 The success rates of recanalization of chronic total occlusions in published series vary from 50% to 80% and depend on several variables such as the estimated age of occlusion, angiographic type of occlusion (tapered vs abrupt), presence of bridging collaterals, side branches originating at the point of occlusion, and length of the occlusion.2-6 Several recanalization devices have been proposed to improve primary success,7-16 but the best published primary success rates still remain below the success rate of stenotic lesions.2,5 In our institution the recanalization of chronic total coronary occlusion has been done on a large-scale basis since 1989 with the use of different recanalization devices. In this article we report our experience of the selective use of a new guide wire for mechanical recanalization of chronic total occlusions.
Methods Patients and angiographic characteristics From January 1996 to June 1997 percutaneous coronary interventions were performed on 1006 lesions at our institution, of which 25% (250 lesions) were total occlusions. A mechanical approach for recanalization of total occlusions that included the use of the Athlete wire (Asahi Intecc Co., LTD, Seto, Japan) was performed in 86 patients to treat 95 occlusions, representing 38% of all total occlusions treated in this period of From Columbus Hospital. Submitted May 22, 1997; accepted Oct. 22, 1997. Reprint requests: Antonio Colombo, MD, Centro Cuore Columbus, Via Buonarrotti, 48, 20145 Milano, Italy. Copyright © 1998 by Mosby, Inc. 0002-8703/98/$5.00 + 0 4/1/87785
time. The Athlete wire was selected by the operator as a primary device in 10 (11%) cases after one or more conventional wires did not cross the occlusion in 85 (89%) cases. The clinical and angiographic characteristics of patients and lesions are shown in Table I.
Device description The Athlete coronary wire is a 0.014-inch diameter wire with a tip coil design similar to that of steerable coronary standard wires currently used for coronary angioplasty (Fig. 1). This wire has optimal steering characteristics and unique stiffness, kink resistance, and pushability of the 3 cm radiopaque tip segment because of improved jointless spring coil technology (one piece core wire). The Athlete wire has different degrees of tip stiffness expressed as the weight in grams to cause the deflection of the tip (from 2 gm to 8 gm for the “super hard” version). In this study the 5 gm standard tip was used. This wire has been available in our laboratory since January 1996 and was used selectively for recanalization of total coronary occlusions when conventional wires failed to cross. The additionally used Choice PT Plus guide wire with hydrophilic coating (Scimed, Boston Scientific Corp., Maple Grove, Minn.) has minimal friction and floppy characteristics that facilitate its advancement through very narrow segments with increased resistance. In all cases lowprofile 1.5 mm over-the-wire balloons were used (Predator, Cordis Corp., Johnson & Johnson Company, Miami, Fla.; Bandit or Ranger, Scimed, Maple Grove, Minn.).
Definitions A total coronary occlusion was defined as a complete interruption of the lumen of the vessel for a certain segment with no anterograde flow through the lumen. If anterograde flow was present, it occurred through bridging collaterals. Successful crossing of the total occlusion by the guide wire was defined as the passage of the guide wire into the seg-
American Heart Journal Volume 135, Number 4
Figure 1
Jointless spring coil technology of Athlete wire.
Figure 2
Synergistic two-wire approach to chronic total occlusion of right coronary artery that was documented with angiography 8 years before. Crossing obtained with Athlete Standard wire in proximal part and with further progression into distal lumen obtained with Choice PT wire with 1.5 mm over-the-wire balloon for backup.
ment distal to the occlusion site with angiographic visualization of the true lumen of the distal vessel. A wire was considered successful in crossing the occlusion when the complete penetration of the occluded segment was accomplished entirely with that specific wire. Combined wire success was defined when more than one wire was used to cross the entire occlusion length. Angiographic success was defined as subsequent successful balloon angioplasty or other procedures able to restore a patent vessel lumen with a final residual stenosis of <30% and with a Thrombolysis in Myocardial Infarction grade 3 distal blood flow without any immediate complications such as vessel perforation, myocardial infarction, emergency surgery, or death. The angiographic morphologic characteristics of the occlusion were defined as tapered if the occluded segment ended in a funnel-shaped form, or abrupt if it ended without a funnel. Unfavorable lesion morphologic characteristics were defined as the presence of one feature known to be associated with low recanalization success: abrupt type of occlusion, presence of bridging collaterals, side branches originating at the point of occlusion, and length of the occlusion ≥15 mm. The age of chronic total occlusion was determined as the
Reimers et al. 727
Table I. Patient and lesion characteristics
Study patients Age* (yr) Male Previous myocardial infarction LV ejection fraction* (%) Lesions attempted Vessel distribution Left anterior descending Left circumflex Right coronary artery Age occlusion* (mo) <3 mo 3 mo to 1 yr ≥1 year Undetermined Bridging collaterals Abrupt occlusion Tapered occlusion Occlusion length ≥15 mm Side branches at occlusion site One or more unfavorable angiographic characteristic Contralateral collaterals
No.
Percent
86 54 ± 9 74 66 57 ± 11 95
100 86 77 100
33 29 33 18 ± 27 15 20 31 29 28 41 54 43 61 79
35 30 35 16 21 33 30 29 43 57 45 64 83
60
63
LV, Left ventricular. *Mean ± SD
time interval from the first angiogram demonstrating the occlusion. When no angiogram was available, history of myocardial infarction or prolonged chest pain with electrocardiographic changes in the territory of distribution of the occluded artery was used to date the occlusion. In the absence of clinical events the occlusion was classified as of undetermined age. The lesion length was measured from the direct vessel injection when the distal vessel was visible through bridging collaterals or with a simultaneous bilateral injection when the distal vessel was visualized only from collaterals supplied by the contralateral coronary artery. The duration of the procedure was calculated as the interval between patient arrival in the catheterization laboratory and the end of the procedure.
Recanalization procedure The target vessel was first cannulated with an 8F guiding catheter. These were Judkins curve 67%, extra backup 24%, and Amplatz curve 9%. In 47 (49%) patients simultaneous injections from a 5F or 6F diagnostic catheter in the contralateral coronary were performed to visualize the vessel distal to the total occlusion supplied by collateral flow. A bolus of 100 U/kg heparin was given at the beginning of the procedure, and activated clotting time was maintained at more than 200 seconds with repeat boluses of heparin. In all cases a 1.5 mm low-profile over-the-wire balloon was used and advanced
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728 Reimers et al.
Figure 3
Table II. Procedural data
Crossing success Athlete wire success* Combined success Athlete and Choice PT wires* Choice PT success 0.010-inch ACS Standard Laser wire success Contralateral injection Tamponade + urgent CABG Local contrast staining Procedure time, minutes† Fluoroscopy time (min) Further treatment in 67 crossed lesions Stent implantation Rotational atherectomy Directional atherectomy Laser catheter Angiographic success with TIMI 3 flow at end of procedure
Lesions
Percent
67 39 21
71 41 22
3 3 1 47 1 14 110 ± 49 44 ± 21
3 3 1 49 1 15
58 6 4 2 62
86 9 6 3 65
CABG, Coronary artery bypass graft; TIMI, thrombolysis in myocardial infarction. *Athlete wire determinant for crossing success in 60 lesions (63%). †Patient stay in the catheterization laboratory.
close to the lesion site to enhance support and to facilitate wire reshaping or exchange without losing the chosen direction and the reached position. Gentle maneuvering and steering of the wire across the occluded segment was tried until the wire penetrated the distal lumen. The maneuvers were stopped when a significant dissection jeopardizing access to the distal true lumen or vessel perforation occurred. In 10 (11%) cases the Athlete wire was used as the first wire. In 85 (89%) lesions the Athlete wire was used after one or more wires could not cross the occlusion. These were mostly (69%) floppy wires such as Choice PT and Hi Torque Floppy (ACS, Temecula, Calif.) and in 20% Intermediate or Standard wires (Hi Torque) or the Terumo Crosswire (Terumo Corp., Tokyo, Japan). In one case a Laser wire (Prima wire, Spectranetics, Colorado Springs, Colo.) was successfully used after failure with the Athlete wire and three other wires occurred. A Laser catheter was used if the balloon catheter could not cross the occlusion. In the 155 occlusions attempted in our laboratory without the Athlete wire, different floppy, intermediate, standard, and coated wires of 0.014-inch and 0.010-inch diameter have been used (Hi torque-ACS, Wizdom-Cordis, Choice PT-Scimed, Silk-USCI, Dasher-Target Therapeutics, Crosswire Terumo).
Comparison with previous results We compared the results obtained with this new approach with those of a group of patients with similar lesion characteristics previously treated at our institution with the classic guide wire approach (intermediate guide wires, standard guide wires, or both). Comparison was performed with the
Total occlusion of left anterior descending coronary artery documented with angiography 3 years before procedure. Note abrupt occlusion (arrow) with large septal side branch originating at occlusion site; after successful crossing with Athlete Standard wire. A good final result is obtained with balloon angioplasty and stent implantation, persistent at follow-up.
chi-squared analysis or Fisher’s exact test according to the number of categoric variables; p < 0.05 was considered statistically significant.
Results Overall crossing success was obtained in 67 (71%) of 95 lesions: in 39 (41%) of 95 cases with the Athlete wire, in 21 (22%) of 95 cases with the combination of Athlete and Choice PT wires, in 3 (3%) of 95 cases with the Choice PT wire, in 3 (3%) of 95 cases with the 0.010-inch ACS standard wire, and in 1 (1%) case with the combination Laser wire and Choice PT. The Athlete guide wire was determinant for successful crossing in 60 (63%) of 95 lesions (Table II). In 21 of these occlusions the Choice PT significantly helped in the progression of the Athlete wire or penetrated the last segment of the occlusion (Fig. 2). In 10 cases the Athlete wire was used as the first wire, of which 6 were successful. In these six cases a possible crossing success with a different type of wire cannot be excluded. After successful guide wire crossing was performed, balloon angioplasty was performed in all 67 lesions. Additional procedures were coronary stenting (86%), rotational atherectomy (9%), directional atherectomy (6%), and Laser catheter atherectomy (3%). Angiographic success with thrombolysis in myocardial infarction 3 flow was obtained in 63 (66%) of 95 lesions. Three illustrative cases of this series are shown in Figs. 2, 3, and 4. Major complications occurred in one (3%) patient, who had coronary perforation and cardiac tamponade and underwent emergency bypass surgery with good
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Figure 4
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Table III. Comparison of recanalization success with the new wire approach versus standard approach New wire approach
Chronic total occlusion of left anterior descending artery (arrow) in patient with anterior myocardial infarction 8 months before. Crossing obtained with Athlete and Choice PT wire with 1.5 mm over-the-wire balloon. Angiographic follow-up shows moderate, not critical, restenosis within stented segment.
final outcome. The perforation occurred after attempted recanalization of a coronary occlusion with five different guide wires and a final attempt with the Athlete wire. Staining of contrast medium outside the vessel lumen caused by guide wire exit occurred in 14 (15%) patients and remained without clinical sequelae. A total of 25 to 50 mg protamine sulphate was given to all these 14 patients, and the procedure was interrupted in nine patients. Perforations were caused in eight cases by the Athlete wire, in five cases by the Choice PT wire, and in one case by a 0.010-inch standard wire. The mean duration of the procedure (time in the catheterization laboratory) was 110 ± 49 minutes (range 50 to 250 minutes) with a mean fluoroscopy time of 44 ± 21 minutes (range 20 to 130 minutes). Twenty-two patients had procedures on other vessels in the same session. Recanalization success of the 155 occlusions attempted without the use of the Athlete wire during the period of the study was obtained in 121 (78%) lesions including acute, subacute, and angiographically more favorable lesions.
Discussion The number of lesions reported in this series is limited, but the results are notable considering the age of many attempted occlusions and the presence of unfavorable morphologic lesion characteristics. Before the
Standard approach
Variable
No.
Percent
No.
Duration of occlusion <1 mo 1-3 mo >3 mo Unknown Abrupt morphology Length of >15 mm Bridging collaterals Overall success
7/7 6/8 35/51 19/29 32/43 30/45 18/28 67/95
100 75 69 66 74 67 64 71
65/73 67/77 49/110 63/105 119/234 123/205 9/31 151/240
Percent p Value
89 87 45 60 51 60 29 63
0.5 0.5 0.08 0.09 0.09 0.4 0.08 0.5
Athlete wire was available, many of the occlusions treated in this population would not have been attempted for revascularization in our institution because of these primary unfavorable characteristics. We compared the present data to results obtained in our laboratory before the introduction of the Athlete wire (Table III).6 At that time we analyzed 365 chronic total occlusions and found several variables that influenced primary success rate such as the operator experience (41% in the early period, 73% in the late period), duration of occlusion (<1 month 89%, >3 months 45%), and morphologic characteristics of the occlusion (tapered 83%, abrupt 51%). Crossing success for the mechanical approach with classic guide wires was 63% in the last 240 occlusions performed with improved operator experience compared with 71% in 95 occlusions with the new guide wires. When the estimated duration of the occlusion was less than 1 month, the recanalization was highly successful with either approach (100% with the new approach and 89% with the classic guide wire approach). In occlusions older than 3 months the success of the new approach was 69%, whereas the success of the classic guide wire approach was only 45%. In occlusions with unfavorable morphologic characteristics, the new approach had a success of 77%, whereas the classic guide wire approach had a success of 53% (p = 0.02). In this study characteristics such as age of occlusion, angiographic type of occlusion, presence of bridging collaterals, side branches at the occlusion site, and length of the occlusion did not affect the final crossing with the new wire approach (Table III). Present numbers, however, are too small to draw final conclusions. The success rate of recanalization of chronic total
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occlusions in this study must be compared with those of other published series. In a randomized study with the Magnum wire (Schneider, Bülach, Switzerland) primary recanalization success was achieved in 45%,7,8 which compares well to the 41% success of the Athlete wire alone. The 63% success rate of the combined use of the Athlete and the Choice PT wire, however, underlines the importance of a synergistic approach of more than one wire. The Terumo hydrophilic coated guide wire had a success rate of 39% to 88%,9-12 the Rotacs low-speed system had a success rate of 66%,14 the use of a vibration guide wire system had a reported success rate of 78%,15 and the Spectranetics Laser wire had 58% to 60% success rate with a 20% incidence of coronary perforation and a 1.3% incidence of cardiac tamponade.16 The Laser wire is a nonmechanical approach to occlusions and is generally used in our laboratory not as a first-line device but when mechanical wires fail. This approach is taken because reported results of the elective use of the laser wire are not superior to those of the mechanical approaches.16 An important technical element of this report is the use of 1.5 mm over-the-wire balloons. Low-profile balloons with tapered and trackable tips confer ability to support the wire up to its very distal end. They also prevent the loss of any reached position inside the occlusion, allowing the operator to remove the wire to reshape the tip or to easily exchange wires as needed to help the progression throughout the occluded segment. The use of small 1.5 mm balloons increases the probability to cross the occlusion not only with the wire but also with the balloon. Furthermore careful balloon inflations to allow visualization of distal flow, especially in the case of a short subintimal passage of the wire before reentrance into the distal lumen, appear less hazardous with smallsized balloons. In the case of acute and subacute or angiographically favorable total occlusions, however, we use normal-sized balloons to start with. A unique characteristic of the Athlete wire is the steerability, which is superior to the steerability of other available wire even when advanced inside the occluded segment. In our experience crossing a total occlusion may require at one level (mainly the proximal and distal extremity of the occlusion or the distal lumen reentrance) a wire with great stiffness and steerability and at another level (possibly within the occlusion or in the distal vessel) a wire with very low friction. The Choice PT wire has an effective complementary role in this approach. Thus it appears to be more appropriate to consider the recanalization technique presented here as
a synergistic approach with a stiff steerable wire, a floppy hydrophilic coated wire, and a low-profile over-thewire balloon. The use of the Athlete wire did not require a learning curve for an experienced operator because its major feature is the increased steerability facilitating the wire advancement in the desired direction. Another element contributing to the success and the safety of these procedures is the use of contralateral injections to visualize the distal vessel in multiple projections, direct the progression of the wire in the occluded segment toward the distal true lumen, and confirm the intraluminal position of the wire after crossing the occluded segment. Thus contralateral injections facilitate and increase the safety of recanalization procedures. The only case in which the Athlete and other mechanical wires failed and final success was achieved with the 0.018-inch Laser wire combined with the Choice PT may bring out the concept that even higher success rates in recanalizing total occlusions can be achieved with a “multidevice” approach. The 1.4 mm Laser catheter was useful in two other cases in which the balloon could not be advanced through the lesion crossed by the wire. Despite the small numbers reported in this study, we believe that these results are very encouraging and support the concept that guide wire and balloon technology can still play an important role in improving the success rate in the field of chronic total occlusions. More sophisticated and more costly approaches must be compared with this evolving “standard” tool to define the possible niche for new devices. The case of cardiac tamponade (1%) with subsequent pericardial drainage and urgent bypass surgery is a reminder of the presence of a discrete procedural risk when total occlusions are attempted. In cases in which perivessel contrast staining was present with no need for surgical intervention, the prompt use of protamine sulphate appeared to be very useful in preventing possible intrapericardial bleeding.
Conclusions With the use of the Athlete guide wire in a synergistic approach with a floppy hydrophilic wire and a low-profile balloon for mechanical recanalization of total chronic occlusions, a success rate of 71% was achieved independent of the age of the occlusion or unfavorable lesion characteristics and with a low incidence of complications. However, larger randomized studies are necessary to evaluate the role of this “new-old technology” for mechanical recanalization of chronic total occlusions.
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We thank Dr. Osamu Katoh (Osaka/Frankfurt), who introduced the Athlete guide wire in our institution.
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