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Healon5: Comparison of 2 removal techniques
Healon5: Comparison of 2 removal techniques Charlotta Zetterstro¨m, MD, PhD, Gisela Wejde, MD, Mikaela Taube, RN Purpose: To evaluate the effect on intraocular pressure (IOP) of the rock ’n roll and behind-the-lens techniques of removing Healon姞5 (sodium hyaluronate 2.3%). Setting: St. Erik’s Eye Hospital, Stockholm, Sweden. Methods: In a prospective randomized study of 159 patients, 2 techniques to remove Healon5—rock ’n roll and behind-the-lens—were compared during cataract surgery. Cataract surgery included identical phacoemulsification performed by 1 surgeon and implantation of a silicone intraocular lens (IOL) in the capsular bag. The removal time of Healon5 was recorded. The IOP was measured preoperatively and 5 and 24 hours postoperatively. Results: The mean IOP before surgery was 15.7 mm Hg ⫾ 2.8 (SD) in the rock ’n roll group and 15.9 ⫾ 2.7 mm Hg in the behind-the-lens group. Five hours postoperatively, the mean IOP was 25.6 ⫾ 10.4 mm Hg and 22.4 ⫾ 7.6 mm Hg, respectively; the difference between the groups was statistically significant. By 24 hours postoperatively, the mean IOP was at preoperative levels in both groups. The mean removal time of Healon5 was 50 seconds in the rock ’n roll group and 39 seconds in the behind-the-lens group; the difference between the groups was statistically significant. Conclusion: Results indicate that the behind-the-lens technique for removing Healon5 is quicker and safer than the rock ’n roll technique. J Cataract Refract Surg 2002; 28:1561–1564 © 2002 ASCRS and ESCRS
T
he development of hyaluronic acid as a viscoelastic substance1 was a significant improvement in cataract surgery. Healon威5 (sodium hyaluronate 2.3%), a relatively new ophthalmic viscosurgical device (OVD), was developed from Healon and contains the same molecular mass of sodium hyaluronate (4 million) but has a higher concentration (2.3 mg/mL versus 1 mg/mL). This makes Healon5 highly viscous and its removal from the eye after surgery different from what the surgeon is used to. Incomplete removal of hyaluronic acid after surgery can increase the postoperative intraocular pressure (IOP).2– 4 Healon5 can be difficult to remove, particularly from behind the intraocular lens (IOL) in the cap-
Accepted for publication December 17, 2001. Reprint requests to Charlotta Zetterstro¨m, MD, PhD, St. Erik’s Eye Hospital, S-112 82 Stockholm, Sweden. © 2002 ASCRS and ESCRS Published by Elsevier Science Inc.
sular bag, and high pressure peaks after surgery have been observed. This prospective randomized study compared 2 techniques to remove Healon5 during cataract surgery. The IOP changes and the OVD removal times were compared between the 2 methods.
Patients and Methods The study included 159 patients with a mean age of 69.8 years ⫾ 9.9 (SD) (range 40 to 83 years) and 68.9 ⫾ 9.5 years (range 44 to 85 years) in the rock ’n roll group and behindthe-lens group, respectively. Eyes with a preoperative IOP of 25 mm Hg or more, glaucoma, diabetic retinopathy, corneal pathology, or history of uveitis were excluded. Informed consent was obtained from all patients. The study was also reviewed and approved by the local ethics committee. Patients were randomly assigned to have rock ’n roll or behind-the-lens removal of Healon5 at the end of surgery. In the rock ’n roll group (n ⫽ 79), the Healon5 was removed using circular movement of the irrigation/aspiration (I/A) handpiece in the anterior chamber at the iris plane. Using 0886-3350/02/$–see front matter PII S0886-3350(02)01271-3
REMOVAL TECHNIQUES FOR HEALON5
gentle pressure with the handpiece on the IOL optic, the handpiece was rotated first to 1 side with the flow directed into the bag and then to the other side using the same maneuver, finally sweeping around the anterior chamber including the angle.5 In the behind-the-lens group (n ⫽ 80), the Healon5 was removed by going behind the IOL without engaging the flow of the I/A tip and starting the removal from the capsular bag. Flow was not engaged until the I/A tip was positioned behind the IOL optic with the aspiration port facing the cornea. The removal was continued by circling the I/A tip at the iris plane and on the optic surface. Finally, an additional sweep was done in the anterior chamber, paying particular attention to the chamber angle. Healon5 removal was considered complete when the IOL was centered in the capsular bag and striae were observed in the posterior capsule (Figure 1). All patients were operated on by the same surgeon (C.Z.) using a standardized technique with the exception of Healon5 removal. Approximately 1 hour before surgery, a combination of topical cyclopentolate 0.75% and phenylephrine 0.25% was instilled 3 times. The surgical procedure included a 3.2 mm corneal incision and intracameral anesthesia by injection of 0.1 to 0.2 mL of lidocaine hydrochloride followed by instillation of the Healon5. The capsulorhexis was created with a bent needle and then a capsulorhexis forceps. Hydrodissection was followed by phacoemulsification of the nucleus and aspiration of the cortical remnants with the I/A tip. The capsular bag was expanded with Healon5, and a 3-piece foldable silicone IOL (SI-55NB威, Allergan) was implanted with an injector. The Healon5 was removed from the eye and the removal time recorded. The Legacy phaco machine (Alcon) was used with the bottle height above eye level (65 cm), a flow rate of 25 to 35 mL/min, and vacuum of 500 mm Hg. The incision was left sutureless in all cases. At the end of surgery, 1 mg of cefroxamide was given intracamerally and the eye was left unpatched. No miotic drugs were used during surgery, and no topical antiglaucoma agents were given immediately after surgery.
Patients received topical dexamethasone 3 times a day during the first postoperative week, 2 times a day for 1 week, and 1 time a day for 1 week. The baseline IOP was measured by Goldmann applanation tonometry before surgery and 5 and 24 hours postoperatively. Statistical analysis was performed by an analysis of variance with the equivalence limit defined as ⫾5 mm Hg.
Results The IOP over time is shown in Table 1 and Figure 2 and the change in IOP from preoperatively in Table 1. The mean change in IOP from preoperatively to 5 hours after was ⫹9.9 mm Hg in the rock ’n roll group and ⫹6.5 mm Hg in the behind-the-lens group, which means the 2 groups were different. The distribution of IOP 5 hours postoperatively is shown in Figure 3. Eight of 79 patients (10%) in the rock ’n roll group and 1 of 80 patients (1%) in the behind-the-lens group had an IOP greater than 40 mm Hg 5 hours postoperatively. The difference between the 2 groups was statistically significant. The IOP returned to preoperative levels in these patients after treatment by aqueous release, 500 mg acetazolamide, and 1 drop of topical timolol maleate 0.5%. No other antiglaucoma agents were used. The mean removal time was 50 seconds in the rock ’n roll group and 39 seconds in the behind-the-lens group; the difference between the groups was statistically significant (Figure 4). Two patients in the rock ’n roll group had a removal time of 2.33 minutes and 2.07 minutes, respectively. The maximum removal time was 2.33 minutes in the rock ’n roll group and 1.46 minutes in the behind-the-lens group. At 5 and 24 hours, no Healon5 was detected in any eye during a slitlamp examination.
Discussion
Figure 1. (Zetterstro¨m) Striae are seen in the posterior capsule when the bag is empty of Healon5. 1562
During cataract surgery, OVDs are used to maintain space and protect the tissues of the eye, particularly the corneal endothelium. The only clinically relevant undesirable effect of OVD use is a transient increase in IOP, especially if any OVD remains in the eye at the end of surgery.2– 4 Based on the postoperative IOP, we found that the behind-the-lens technique (also called the 2-compart-
J CATARACT REFRACT SURG—VOL 28, SEPTEMBER 2002
REMOVAL TECHNIQUES FOR HEALON5
Table 1.
Intraocular pressure over time and change in IOP from preoperatively. Examination
Group
Preop
5 Hours Postop
24 Hours Postop
15.7 ⫾ 2.8
25.6 ⫾ 10.4
16.0 ⫾ 3.9
Rock ’n roll (n ⫽ 79) IOP Mean ⫾ SD Minimum
10
10
8
Maximum
21
60
27
IOP change from preop Mean ⫾ SD
—
9.9 ⫾ 9.6
0.3 ⫾ 3.9
Minimum
—
⫺5
⫺13
Maximum
—
39
14
Behind-the-lens (n ⫽ 80) IOP Mean ⫾ SD
15.9 ⫾ 2.7
22.4 ⫾ 7.6
16.8 ⫾4.3
Minimum
8
2
8
Maximum
22
49
31
IOP change from preop Mean ⫾ SD
—
6.5 ⫾ 7.5
0.9 ⫾ 3.8
Minimum
—
⫺15
⫺6
Maximum
—
32
11
Figure 2. (Zetterstro¨ m) Intraocular pressure over time.
Figure 3. (Zetterstro¨ m) Intraocular pressure distribution 5 hours postoperatively.
ment technique6), in which the Healon5 is removed from behind the IOL as well as from the anterior chamber, is safer than the rock ’n roll technique, in which the OVD is removed only from the anterior chamber. An in vitro study found that with some OVDs, I/A from behind the IOL is necessary for complete removal.7
Healon5 has both cohesive and dispersive properties; thus, it protects the eye tissue during surgery and is easy to break up and remove from the eye.8 Before the availability of Healon5, 2 OVDs had to be used for the dispersive– cohesive soft-shell technique in cataract surgery.9
J CATARACT REFRACT SURG—VOL 28, SEPTEMBER 2002
1563
REMOVAL TECHNIQUES FOR HEALON5
References
Figure 4. (Zetterstro¨ m) Healon 5 removal time ⫾ SD (Sec ⫽ seconds).
It is important to use high phaco machine settings to remove Healon5. We used a bottle height of 65 cm, a flow rate of 25 to 35 mL/min, and vacuum of 500 mm Hg. The highest IOP in our study was at 5 hours postoperatively. The IOP quickly decreased within the first day, which agrees with the findings of Rainer et al.10 Patients who developed an IOP higher than 40 mm Hg 5 hours after surgery were treated with aqueous release, 500 mg acetazolamide, and 1 drop of topical timolol maleate 0.5%. In all cases, the IOP returned to preoperative values 24 hours after surgery with no other antiglaucoma agents. Thus, our treatment regimen seems effective and safe. Previous studies found minimal corneal endothelial cell loss after surgery using Healon5,11,12 making the OVD a good choice in patients with significant corneal pathology or a low preoperative endothelial cell count. Healon5 also provides good anterior chamber stability and protection of the cornea, making it suitable for beginning phaco surgeons. In conclusion, the results in our study show that I/A behind the IOL should be the first step in removing Healon5 from the eye at the end of surgery.
1564
1. Balazs EA. Ultrapure hyaluronic acid and the use of thereof. U.S. Patent No. 4.141.973,1973, October 1979. 2. Percival SPB. Complications from use of sodium hyaluronate (Healonid) in anterior segment surgery. Br J Ophthalmol 1982; 66:714 –716 3. Passo MS, Ernest JT, Goldstick TK. Hyaluronate increases intraocular pressure when used in cataract extraction. Br J Ophthalmol 1985; 69:572–575 4. Fry LL. Postoperative intraocular pressure rises: a comparison of Healon, Amvisc, and Viscoat. J Cataract Refract Surg 1989; 15:415–420 5. Arshinoff SA. Rock ‘n’ roll removal of Healon GV. In: Arshinoff SA, ed, Proceedings of the 7th Annual National Ophthalmic Speakers Program. Quebec, Medicopea, 1997; 29 –30 6. Tetz MR, Holzer MP. Two-compartment technique to remove ophthalmic viscosurgical devices. J Cataract Refract Surg 2000; 26:641–643 7. Assia EI, Apple DJ, Lim ES, et al. Removal of viscoelastic materials after experimental cataract surgery in vitro. J Cataract Refract Surg 1992; 18:3–6 8. Dick HB, Krummenauer F, Augustin AJ, et al. Healon5 viscoadaptive formulation: comparison to Healon and Healon GV. J Cataract Refract Surg 2001; 27:320 –326 9. Arshinoff SA. Dispersive-cohesive viscoelastic soft shell technique. J Cataract Refract Surg 1999; 25:167–173 10. Rainer G, Menapace R, Findl O, et al. Intraocular pressure after small incision cataract surgery with Healon5 and Viscoat. J Cataract Refract Surg 2000; 26:271– 276 11. Schwenn O, Dick HB, Krummenauer F, et al. Healon5 versus Viscoat during cataract surgery: intraocular pressure, laser flare and corneal changes. Graefes Arch Clin Exp Ophthalmol 2000; 238:861–867 12. Holzer MP, Tetz MR, Auffarth GU, et al. Effect of Healon5 and 4 other viscoelastic substances on intraocular pressure and endothelium after cataract surgery. J Cataract Refract Surg 2001; 27:213–218 From the Department of Ophthalmology, St. Erik’s Eye Hospital/Karolinska Institute, Stockholm, Sweden. Presented at the Symposium on Cataract, IOL and Refractive Surgery, Boston, Massachusetts, USA, May 2000, and the XVIIIth Congress of the European Society of Cataract & Refractive Surgeons, Brussels, Belgium, September 2000. None of the authors has a financial or proprietary interest in any material or method mentioned.
J CATARACT REFRACT SURG—VOL 28, SEPTEMBER 2002
T
he development of hyaluronic acid as a viscoelastic substance1 was a significant improvement in cataract surgery. Healon威5 (sodium hyaluronate 2.3%), a relatively new ophthalmic viscosurgical device (OVD), was developed from Healon and contains the same molecular mass of sodium hyaluronate (4 million) but has a higher concentration (2.3 mg/mL versus 1 mg/mL). This makes Healon5 highly viscous and its removal from the eye after surgery different from what the surgeon is used to. Incomplete removal of hyaluronic acid after surgery can increase the postoperative intraocular pressure (IOP).2– 4 Healon5 can be difficult to remove, particularly from behind the intraocular lens (IOL) in the cap-
Accepted for publication December 17, 2001. Reprint requests to Charlotta Zetterstro¨m, MD, PhD, St. Erik’s Eye Hospital, S-112 82 Stockholm, Sweden. © 2002 ASCRS and ESCRS Published by Elsevier Science Inc.
sular bag, and high pressure peaks after surgery have been observed. This prospective randomized study compared 2 techniques to remove Healon5 during cataract surgery. The IOP changes and the OVD removal times were compared between the 2 methods.
Patients and Methods The study included 159 patients with a mean age of 69.8 years ⫾ 9.9 (SD) (range 40 to 83 years) and 68.9 ⫾ 9.5 years (range 44 to 85 years) in the rock ’n roll group and behindthe-lens group, respectively. Eyes with a preoperative IOP of 25 mm Hg or more, glaucoma, diabetic retinopathy, corneal pathology, or history of uveitis were excluded. Informed consent was obtained from all patients. The study was also reviewed and approved by the local ethics committee. Patients were randomly assigned to have rock ’n roll or behind-the-lens removal of Healon5 at the end of surgery. In the rock ’n roll group (n ⫽ 79), the Healon5 was removed using circular movement of the irrigation/aspiration (I/A) handpiece in the anterior chamber at the iris plane. Using 0886-3350/02/$–see front matter PII S0886-3350(02)01271-3
REMOVAL TECHNIQUES FOR HEALON5
gentle pressure with the handpiece on the IOL optic, the handpiece was rotated first to 1 side with the flow directed into the bag and then to the other side using the same maneuver, finally sweeping around the anterior chamber including the angle.5 In the behind-the-lens group (n ⫽ 80), the Healon5 was removed by going behind the IOL without engaging the flow of the I/A tip and starting the removal from the capsular bag. Flow was not engaged until the I/A tip was positioned behind the IOL optic with the aspiration port facing the cornea. The removal was continued by circling the I/A tip at the iris plane and on the optic surface. Finally, an additional sweep was done in the anterior chamber, paying particular attention to the chamber angle. Healon5 removal was considered complete when the IOL was centered in the capsular bag and striae were observed in the posterior capsule (Figure 1). All patients were operated on by the same surgeon (C.Z.) using a standardized technique with the exception of Healon5 removal. Approximately 1 hour before surgery, a combination of topical cyclopentolate 0.75% and phenylephrine 0.25% was instilled 3 times. The surgical procedure included a 3.2 mm corneal incision and intracameral anesthesia by injection of 0.1 to 0.2 mL of lidocaine hydrochloride followed by instillation of the Healon5. The capsulorhexis was created with a bent needle and then a capsulorhexis forceps. Hydrodissection was followed by phacoemulsification of the nucleus and aspiration of the cortical remnants with the I/A tip. The capsular bag was expanded with Healon5, and a 3-piece foldable silicone IOL (SI-55NB威, Allergan) was implanted with an injector. The Healon5 was removed from the eye and the removal time recorded. The Legacy phaco machine (Alcon) was used with the bottle height above eye level (65 cm), a flow rate of 25 to 35 mL/min, and vacuum of 500 mm Hg. The incision was left sutureless in all cases. At the end of surgery, 1 mg of cefroxamide was given intracamerally and the eye was left unpatched. No miotic drugs were used during surgery, and no topical antiglaucoma agents were given immediately after surgery.
Patients received topical dexamethasone 3 times a day during the first postoperative week, 2 times a day for 1 week, and 1 time a day for 1 week. The baseline IOP was measured by Goldmann applanation tonometry before surgery and 5 and 24 hours postoperatively. Statistical analysis was performed by an analysis of variance with the equivalence limit defined as ⫾5 mm Hg.
Results The IOP over time is shown in Table 1 and Figure 2 and the change in IOP from preoperatively in Table 1. The mean change in IOP from preoperatively to 5 hours after was ⫹9.9 mm Hg in the rock ’n roll group and ⫹6.5 mm Hg in the behind-the-lens group, which means the 2 groups were different. The distribution of IOP 5 hours postoperatively is shown in Figure 3. Eight of 79 patients (10%) in the rock ’n roll group and 1 of 80 patients (1%) in the behind-the-lens group had an IOP greater than 40 mm Hg 5 hours postoperatively. The difference between the 2 groups was statistically significant. The IOP returned to preoperative levels in these patients after treatment by aqueous release, 500 mg acetazolamide, and 1 drop of topical timolol maleate 0.5%. No other antiglaucoma agents were used. The mean removal time was 50 seconds in the rock ’n roll group and 39 seconds in the behind-the-lens group; the difference between the groups was statistically significant (Figure 4). Two patients in the rock ’n roll group had a removal time of 2.33 minutes and 2.07 minutes, respectively. The maximum removal time was 2.33 minutes in the rock ’n roll group and 1.46 minutes in the behind-the-lens group. At 5 and 24 hours, no Healon5 was detected in any eye during a slitlamp examination.
Discussion
Figure 1. (Zetterstro¨m) Striae are seen in the posterior capsule when the bag is empty of Healon5. 1562
During cataract surgery, OVDs are used to maintain space and protect the tissues of the eye, particularly the corneal endothelium. The only clinically relevant undesirable effect of OVD use is a transient increase in IOP, especially if any OVD remains in the eye at the end of surgery.2– 4 Based on the postoperative IOP, we found that the behind-the-lens technique (also called the 2-compart-
J CATARACT REFRACT SURG—VOL 28, SEPTEMBER 2002
REMOVAL TECHNIQUES FOR HEALON5
Table 1.
Intraocular pressure over time and change in IOP from preoperatively. Examination
Group
Preop
5 Hours Postop
24 Hours Postop
15.7 ⫾ 2.8
25.6 ⫾ 10.4
16.0 ⫾ 3.9
Rock ’n roll (n ⫽ 79) IOP Mean ⫾ SD Minimum
10
10
8
Maximum
21
60
27
IOP change from preop Mean ⫾ SD
—
9.9 ⫾ 9.6
0.3 ⫾ 3.9
Minimum
—
⫺5
⫺13
Maximum
—
39
14
Behind-the-lens (n ⫽ 80) IOP Mean ⫾ SD
15.9 ⫾ 2.7
22.4 ⫾ 7.6
16.8 ⫾4.3
Minimum
8
2
8
Maximum
22
49
31
IOP change from preop Mean ⫾ SD
—
6.5 ⫾ 7.5
0.9 ⫾ 3.8
Minimum
—
⫺15
⫺6
Maximum
—
32
11
Figure 2. (Zetterstro¨ m) Intraocular pressure over time.
Figure 3. (Zetterstro¨ m) Intraocular pressure distribution 5 hours postoperatively.
ment technique6), in which the Healon5 is removed from behind the IOL as well as from the anterior chamber, is safer than the rock ’n roll technique, in which the OVD is removed only from the anterior chamber. An in vitro study found that with some OVDs, I/A from behind the IOL is necessary for complete removal.7
Healon5 has both cohesive and dispersive properties; thus, it protects the eye tissue during surgery and is easy to break up and remove from the eye.8 Before the availability of Healon5, 2 OVDs had to be used for the dispersive– cohesive soft-shell technique in cataract surgery.9
J CATARACT REFRACT SURG—VOL 28, SEPTEMBER 2002
1563
REMOVAL TECHNIQUES FOR HEALON5
References
Figure 4. (Zetterstro¨ m) Healon 5 removal time ⫾ SD (Sec ⫽ seconds).
It is important to use high phaco machine settings to remove Healon5. We used a bottle height of 65 cm, a flow rate of 25 to 35 mL/min, and vacuum of 500 mm Hg. The highest IOP in our study was at 5 hours postoperatively. The IOP quickly decreased within the first day, which agrees with the findings of Rainer et al.10 Patients who developed an IOP higher than 40 mm Hg 5 hours after surgery were treated with aqueous release, 500 mg acetazolamide, and 1 drop of topical timolol maleate 0.5%. In all cases, the IOP returned to preoperative values 24 hours after surgery with no other antiglaucoma agents. Thus, our treatment regimen seems effective and safe. Previous studies found minimal corneal endothelial cell loss after surgery using Healon5,11,12 making the OVD a good choice in patients with significant corneal pathology or a low preoperative endothelial cell count. Healon5 also provides good anterior chamber stability and protection of the cornea, making it suitable for beginning phaco surgeons. In conclusion, the results in our study show that I/A behind the IOL should be the first step in removing Healon5 from the eye at the end of surgery.
1564
1. Balazs EA. Ultrapure hyaluronic acid and the use of thereof. U.S. Patent No. 4.141.973,1973, October 1979. 2. Percival SPB. Complications from use of sodium hyaluronate (Healonid) in anterior segment surgery. Br J Ophthalmol 1982; 66:714 –716 3. Passo MS, Ernest JT, Goldstick TK. Hyaluronate increases intraocular pressure when used in cataract extraction. Br J Ophthalmol 1985; 69:572–575 4. Fry LL. Postoperative intraocular pressure rises: a comparison of Healon, Amvisc, and Viscoat. J Cataract Refract Surg 1989; 15:415–420 5. Arshinoff SA. Rock ‘n’ roll removal of Healon GV. In: Arshinoff SA, ed, Proceedings of the 7th Annual National Ophthalmic Speakers Program. Quebec, Medicopea, 1997; 29 –30 6. Tetz MR, Holzer MP. Two-compartment technique to remove ophthalmic viscosurgical devices. J Cataract Refract Surg 2000; 26:641–643 7. Assia EI, Apple DJ, Lim ES, et al. Removal of viscoelastic materials after experimental cataract surgery in vitro. J Cataract Refract Surg 1992; 18:3–6 8. Dick HB, Krummenauer F, Augustin AJ, et al. Healon5 viscoadaptive formulation: comparison to Healon and Healon GV. J Cataract Refract Surg 2001; 27:320 –326 9. Arshinoff SA. Dispersive-cohesive viscoelastic soft shell technique. J Cataract Refract Surg 1999; 25:167–173 10. Rainer G, Menapace R, Findl O, et al. Intraocular pressure after small incision cataract surgery with Healon5 and Viscoat. J Cataract Refract Surg 2000; 26:271– 276 11. Schwenn O, Dick HB, Krummenauer F, et al. Healon5 versus Viscoat during cataract surgery: intraocular pressure, laser flare and corneal changes. Graefes Arch Clin Exp Ophthalmol 2000; 238:861–867 12. Holzer MP, Tetz MR, Auffarth GU, et al. Effect of Healon5 and 4 other viscoelastic substances on intraocular pressure and endothelium after cataract surgery. J Cataract Refract Surg 2001; 27:213–218 From the Department of Ophthalmology, St. Erik’s Eye Hospital/Karolinska Institute, Stockholm, Sweden. Presented at the Symposium on Cataract, IOL and Refractive Surgery, Boston, Massachusetts, USA, May 2000, and the XVIIIth Congress of the European Society of Cataract & Refractive Surgeons, Brussels, Belgium, September 2000. None of the authors has a financial or proprietary interest in any material or method mentioned.
J CATARACT REFRACT SURG—VOL 28, SEPTEMBER 2002