Laser angioplasty in the lower extremities: An early surgical experience Francisco J. Criado, MD, Luis A. Queral, MD, Peggy Patten, and Diane Rudolphi, R N , BSN, Baltimore, Md. From July 1988 through December 1988 laser "hot tip" angioplasties coupled with baUoon dilations were performed on 95 patients at the Union Memorial and University of Maryland hospitals. The patients ranged in age from 42 to 84 years (mean, 66.4 years), and there were 61 men and 34 women in the study. Indications for the procedure included claudication in 70 (74%) and severe ischemia in 25 (26%). Noninvasive studies were performed on all patients before and after the procedure. One hundred seventeen segments were treated in 28 iliac arteries and 89 superficial femoral/popliteal arteries. No tibial arteries were treated. Fifty-two stenoses and 65 occlusions occurred. The procedures were performed percutaneously in 52 patients (55%), and open surgical technique was used in 43 patients (45%). Nine immediate failures (9.5%) and 86 successes (90.5%) were noted within 24 hours of the procedure. Follow-up ranged from 1 to 6 months with a mean of 3.2 months. Late failures within this time period occurred in 21 patients (22%). The total failure rate was 30/95 or 3L5%. 0nly one of the patients was made worse by a failed laser-assisted balloon angioplasty. Immediate complications consisted of formation of subcutaneous hematoma in 20 of the 52 patients having percutaneous procedures (38%) and healing difficulty in 3 of the 43 patients having open surgical procedures (7%). Hospital stay was usually 1 day longer in thelatter group. No patient required surgical intervention for bleeding as a result of a vessel perforation. However, this phenomenon was noted during the course of three superficial femoral artery laser-assisted balloon angioplasdes. No limb loss or patient death occurred in this series. In conclusion, laserassisted balloon angioplasty appears to be a safe procedure with a low morbidity. However, it does have a high degree of early hemodynamic failure, which may be reduced in the future with better patient selection. (1 VASe S~3tt~ 1990;11:532-5.)
Laser-beam destruction of atherosclerotic plaque was first demonstrated by Marcruz et all in 1980. Since then, laser vascular technology has evolved rapidly and produced several systems capable of accomplishing transluminal recanalization of stenotic and occlusive atherosclerotic lesions. Both direct-beam and thermal (hot-tip) laser devices are being used clinically in selected cases of lower extremity arterial insufficiency. 2 The objective of this report focuses on a retrospective analysis of the first 6 months' experience with thermal laser-assisted angioplasty (TLAA) as an adjunct to conventional balloon angioplasty in our surgical vascular interventional unit.
From Maryland Vascular Institute at Union Memorial Hospital and University of Maryland Medical System. Presented at the Third Annual Meeting of the Eastern Vascular Society, Bermuda, May 4-7, 1989. Reprint requests: Francisco J. Criado, MD, Maryland Vascular Institute at Union Memorial Hospital, 201 E. University Parkway, Baltimore, MD 21218. 24/6/18270
532
MATERIAL AND METHODS The study group consists of 95 patients who undcrwent TLAA in the lower extrcmities from July through December 1988. In this initial series TLAA was performed in all patients with either stcnoti~ lesions or occlusions measuring 5 cm or less in length according to prcprocedure angiography. The paticnts ranged in age from 42 to 84 years (mean 66.4 years), and thcrc wcrc 61 men and 34 women. Indications for laser intervention were claudication in 70 (74%) and critical ischcmia in 25 (26%). Noninvasive hemodynamic evaluation by pulse volume recording and segmental Doppler pressure and indexes was performed on all paticnts before and aftcr thc procedurc. One hundred seventeen arterial segments/lesions were treated, 28 wcre in the iliac artcry and 89 wcre in the supcrficial femoral artery (SFA)/popliteal artery. No infrapopliteal interventions were performed during the study period. FiftT-two of the 117 lcsions were stcnotic, and 65 were occlusive. The procedures wcre pcrformed percutaneously in 52 patients (55 %) and by open surgical exposure in 43 (45%). Percu-, tancous arterial punctures of the ipsilatcral commoff
Volume 11 Number 4 April 1990
Laser~balloon angioplasty: A n early surgical experience 533
Table I. Results of laser/balloon angioplasty of iliac and SFA lesions~ Arterial segments treated in 95 patients
Lesion~
Mean length of lesions (cm)
Common lilac (including 5 Occlusions bifurcation) 11 Stenoses n = 16 External iliac 4 Occlusions n = 12 8 Stenoses
2.6 1.2
3 Occlusions 5 Stenoses
4.3 5.2
Mid SFA n = 38
28 Occlusions 10 Stenoses
6.3 10.1
Distal SFA n = 29
20 9
Occlusions Stenoses
8.2 6.3
5 Occlusions 9 Stenoses
2.1 4.3
Proximal SFA n=8
Popliteal n = 14 Summary: 28 Iliac arteries 89 SFA/pop
65 Occlusions 52 Stenoses
2.0 0.9
Severity of daudication~ 2 Mild 8 Moderate 2 Severe 1 Mild 6 Moderate 1 Severe 1 Mild 4 Moderate 2 Severe 6 Mild 15 Moderate
Critical degree of ischemia~
Immediate results
Early results (12 weeks)
3
All successful
All successful
2
All successful
11 Successful 1 Failure
2
7 Successful 1 Failure
6 Successes 2 Failures
12
34 Successes 4 Failures
29 Successes 9 Failures
9 Severe 3 Mild 8 26 Successes 12 Moderate 3 Failures 5 Severe 1 Mild 6 13 Successes 2 Moderate 1 Failure 4 Severe 70 patients with 25 patients with acute 86 Successes claudication ischemia 9 Failures
17 Successes 12 Failures 8 Failures 6 Failures 65 Successes 30 Failures
~SFA indicatessuperficialfemgralartery. tListed by segments in total o f 70 patients With claudication and 25 patients with critical ischemia. Moderate claudication denotes ability to walk 2 blocks, less distance is severe, and more is mild daudication.
femoral artery (CFA) were followed by the insertion of an 8.0 or 9.0F introducer sheath into either the iliac artery or SFA. Patients were then anticoagulated with 5000 units of intravenous heparin. Intraoperative angiography was carried out to document the site and extent of the lesion with the use of a C-arm. Under fluoroscopic control, a guide wire was advanced through the lesion wherever possible. Subsequent hot-tip angioplasty was performed over the guide wire with continuous motion to pre• znt arterial wall perforations. Open surgical exposure of the CFA was carried out when specific indications were present. The technique involved the use of a Trimedyne (Santa Ana, Calif.) Nd:YAG laser source and delivery through a 2.5 mm laser probe advanced transluminally to the lesion. Twelve to 14 W of energy were delivered to the metal tip of the probe. Once an appropriate channel had been created, conventional balloon angioplasty was performed as a completion adjunct. RESULTS Failures were classified as immediate or shortterm. Immediate failures comprised those cases in which the recanalization procedure proved technically unfeasible or failed within 24 hours. There were rline (9.5%) immediate failures. Follow-up ranged from 1 to 6 months with a mean of 3.2 months.
Short-term failure within this time period occurred in 21 patients (22%). Overall, 30 of 95 patients (31.5%) had an unsuccessful outcome. Only one of these patients was made worse by a failed TLAA. Success was defined by three criteria: angiographic recanalization or luminal enlargement, symptomatic improvement with increased walking ability, and the increase of at least 0.1 in the Doppler systolic pressure ratio at a segment immediately below the angioplasty site: The 65 patients (68.5%) categorized as having a successful TLAA had angiographic confirmation of anatomic patency coupled with improvement or resolution of claudication and noninvasive documentation of improved arterial flow to the limb. Complications related to the procedure included formation of a groin hematoma in 20 of 52 patients undergoing percutaneous TLAA (38%). However, surgical evacuation was required in only one of these cases. Healing difficulties (minor dehiscence or superficial infection) occurred in three of the 43 open procedures (7%). The average hospital stay (1 to 5 days) was prolonged by 1 day in patients having an open surgical access. Laser probe perforation of the SFA/popliteal artery was noted during the performance o f the laser recanalization in three patients. None required surgical intervention. No iliac perforations occurred during the study period. No instance of clinically significant embolization, limb
534 Criado et al.
Table II. Indication for femoral cut-down Severe lesion in the common femoral artery Severe stenosis in the proximal superficial femoral artery Very obese individuals Situations requiting post-procedure anticoagulation
loss, or death occurred in any of the patients in this series. DISCUSSION Initial clinical experience 3-5 with a laser-heated, metallic-capped, fiberoptic catheter suggests that TLAA is a safe technique. In addition, recurrent stenosis after thermal laser recanalization of experimental arteriosclerosis in animals appears to be less than after balloon dilations. 6 However, early clinical trials assessing laser recanalization of SFA or popliteal arteries have been disappointing. 7 Although initial channels can be created through areas of complete arterial occlusion in up to 90% of patients, clinically successful recanalization can be accomplished only approximately 50% of the time. Clinical success has been improved by adding balloon dilation to thermal angioplasty as reported by Myler et al. 8 and Abela et al. 9 It appears that this combination of laser recanalization and balloon dilation gives optimal resuits at present and was therefore used in this group of patients. Nevertheless, TLAA remains a somewhat controversial therapeutic modality. Definition of patient selection and uncertainties regarding durability are among the key concerns. It would appear safe to state that this is a technique, similar to other transluminal interventions, aimed primarily at the patient with claudication who can be demonstrated to have a favorable iliac or SFA/popliteal lesion, that is, those atherosclerotic occlusions that are 5 cm in length or less and lack extensive calcification. Longer, more heavily calcified lesions, and distal infrapopliteal occlusions are not generally amenable to successful TLAA in its current form. Our results are in line with such contentions (Table I). Our failures were largely in distal SFA lesions that were obstructed. Close evaluation of these patients has taught us that obstructions of the SFA longer than 7 cm are very likely to not respond well to laser-assisted balloon angioplasty~ This subset of patients should either remain untreated or undergo standard femoral-popliteal bypass grafting. However, future innovations in laser technology may very well alter our approach. C a s e selection and evaluation must include objective hemodynamic testing if meaningful assessment is to be obtained. Our follow-up protocol con-
Journal of VASCULAR SURGERY
sists of clinical assessment and hemodynamic evaluation by Doppler segmental pressures at 24 hours, 2 weeks, and every 3 months thereafter. All patients are maintained on aspirin 325 mg daily beginning within 48 hours before the procedure. The group of patients who were classified a success in this series clearly had a hemodynamic improvement in arterial flow to the limb. Conversely, the 31.5% of patients who had an unsuccessful outcome either failed immediately (9.5%) or within several months of the procedure (22%). This latter patient subgroup was readily identifiable because they complained of recurrence of claudication when seen in follow-up at the office. It is also very important to note that only one patient was worsened by a failed TLAA. This patient became severely ischemic 7 weeks after TLAA and required a bypass placement to achieve limb salvage. It is fair to assume that the failed TLAA adversely affected the natural history o f claudication in this particular patient. As such, this comp!icatior~As both serious and notable. Groin hematomas were the most frequent complication occurring in 38% of percutaneous cases. This rate seems quite high and has not been reported as such by our radiology or cardiology colleagues. Our criteria for hematoma were quite strict, and this may account for our high incidence. Any patient who was noted to have a solid lump in the groin larger than 3 cm in diameter was included in this group. Patients often complained of pain over the groin associated with these small hematomas. Resolution usually took place within 4 to 6 weeks of the procedure. Only one patient required surgical exploration to evacuate the hematoma and arrest hemorrhage. We have learned that formation of a hemator~_. can be lessened by not removing the introducer sheath until the patient has been in the recovery room for approximately i hour after the termination of the procedure. Surgical approach to the CFA obviates formation of a hematoma as a complication, but other problems involving healing difficulties arose in 7% of cases. It does appear clear that there are clear-cut indications for "cutting down" on the artery, and these are listed on Table II. As expected, a surgical incision will prolong hospital stay, but only by 1 day. In summary, the approach strategy is most critical. Percutaneous procedures have tremendous appeal, but because a size 8F or larger introducer sheath is required a groin hematoma develops frequently. However, in most cases the hematoma does not alter outcome, and surgical evacuation is very seldom nec~ essary. , W e have seen no instances of formation ol
Volume 11 Number 4 April 1990
p s e u d o a n e u r y s m at the puncture site. Proper technique and timing o f sheath removal and finger compression o f the femoral artery at the groin are essential if incidence o f this complication is to be minimized. Arterial perforation with extravasation o f contrast material was n o t e d in three patients. All these were in the SFA and n o n e o f the patients required surgical exploration. N o iliac perforation occurred during the study period. Verbal reports f r o m other clinical investigators relate these as being m u c h m o r e serious. W e found the lack o f significant atheroembolization a pleasant surprise. O u r clinical experience with diseased b l o o d vessels suggested that o u r experience w o u l d t u r n o u t differently. Nevertheless, ang i o g r a p h y p e r f o r m e d in the operating r o o m after T L A A failed to show a single case o f embolization. W e n o t e d no clinical evidence o f this potential compl;nation in o u r follow-up o f these patients. Perhaps this lack o f embolization accounts for the fact that no limb loss occurred in this series. Laser p r o b e recanalization finds its best indication in short iliac and m i d SFA occlusions. Stenotic lesions can also be "debulked" with a laser p r o b e tracked Over a wire before balloon dilation. H o w e v e r , the evidence is presently scarce regarding any longt e r m benefits over balloon angioplasty alone. Lastly, it is i m p o r t a n t to note that Seeger et al. :° have estimated that as few as I 0 % to i 5 % o f patients with peripheral vascular disease w o u l d be amenable to laser angioplasty in the lower extemities. Therefore it w o u l d appear that this technology w o u l d have a rather limited clinical application at present.
Laser~balloon angioplasty: An early surgical experience 535
REFERENCES
1. Marcruz R, Martins JRM, Turpinanba AS, et al. Therapeutic possibilities of laser beams in atheromas. Arg Bras Cardiol 1980;34:9-12. 2. White RA, White GH. The current and future role of lasers in vascular surgery. Perspectives in Vase. Surg. 1988;1: 1-20. 3. Sanbom TA, Cumberland DC, Tayler DI, Ryan TJ. Human percutaneous laser thermal angioplasry [Abstract]. Circulation 1985;72:[suppl III]:303. 4. Cumberland DC, Sanborn TA, Tayloer DI, et al. Percutancous laser thermal angioplasty: initial clinical results with a laser probe in total peripheral artery occlusions. Lancet 1986;1:1457-9. 5. Sanborn TA, Greenfield AJ, Guben JK, Menzoian JO, LoGerfo FW. Human percutaneous and intraoperative laser thermal angioplasty: initial clinical results as an adjunct to balloon angioplasty. J Vasc Surg 1987;5:83-90. 6. Sanborn TA, Haudenschild CC, Graber GR, Ryan TJ, Farm DP. Angiographic and histologic consequences of laser thermal angioplasty: comparison with balloon angioplasty. Circulation 1987;25:1281-6. 7. Cumberland DC, Sanborn TA, Taylor DI, et al. Percutaneous laser thermal angioplasty: initial clinical results with a laser probe in total peripheral artery occlusions. Lancet 1986;2: 1457-9. 8. Myler RK, Cumberland DA, Clark DA, Stertzer SH, Tatpati DA, Sarma PKS. High and low power thermal laser angioplasty for total occlusions and restenosis in man. Circulation 1987;76(Suppl IV) :230. 9. Abela FS, Seeger JM, Khoury AI, Jablonski S, Conti CR. Laser recanalization of peripheral arteries of humans. Acute and long term effects. Circulation 1987;76(Suppl IV): 409. 10. Seeger JM, Abela GS, Sitverman SH, Jablonski SK. Initial results of laser recanalization in lower extremity arterial reconstruction. J Vasc Surg 1989;9:10-7.
Laser-beam destruction of atherosclerotic plaque was first demonstrated by Marcruz et all in 1980. Since then, laser vascular technology has evolved rapidly and produced several systems capable of accomplishing transluminal recanalization of stenotic and occlusive atherosclerotic lesions. Both direct-beam and thermal (hot-tip) laser devices are being used clinically in selected cases of lower extremity arterial insufficiency. 2 The objective of this report focuses on a retrospective analysis of the first 6 months' experience with thermal laser-assisted angioplasty (TLAA) as an adjunct to conventional balloon angioplasty in our surgical vascular interventional unit.
From Maryland Vascular Institute at Union Memorial Hospital and University of Maryland Medical System. Presented at the Third Annual Meeting of the Eastern Vascular Society, Bermuda, May 4-7, 1989. Reprint requests: Francisco J. Criado, MD, Maryland Vascular Institute at Union Memorial Hospital, 201 E. University Parkway, Baltimore, MD 21218. 24/6/18270
532
MATERIAL AND METHODS The study group consists of 95 patients who undcrwent TLAA in the lower extrcmities from July through December 1988. In this initial series TLAA was performed in all patients with either stcnoti~ lesions or occlusions measuring 5 cm or less in length according to prcprocedure angiography. The paticnts ranged in age from 42 to 84 years (mean 66.4 years), and thcrc wcrc 61 men and 34 women. Indications for laser intervention were claudication in 70 (74%) and critical ischcmia in 25 (26%). Noninvasive hemodynamic evaluation by pulse volume recording and segmental Doppler pressure and indexes was performed on all paticnts before and aftcr thc procedurc. One hundred seventeen arterial segments/lesions were treated, 28 wcre in the iliac artcry and 89 wcre in the supcrficial femoral artery (SFA)/popliteal artery. No infrapopliteal interventions were performed during the study period. FiftT-two of the 117 lcsions were stcnotic, and 65 were occlusive. The procedures wcre pcrformed percutaneously in 52 patients (55 %) and by open surgical exposure in 43 (45%). Percu-, tancous arterial punctures of the ipsilatcral commoff
Volume 11 Number 4 April 1990
Laser~balloon angioplasty: A n early surgical experience 533
Table I. Results of laser/balloon angioplasty of iliac and SFA lesions~ Arterial segments treated in 95 patients
Lesion~
Mean length of lesions (cm)
Common lilac (including 5 Occlusions bifurcation) 11 Stenoses n = 16 External iliac 4 Occlusions n = 12 8 Stenoses
2.6 1.2
3 Occlusions 5 Stenoses
4.3 5.2
Mid SFA n = 38
28 Occlusions 10 Stenoses
6.3 10.1
Distal SFA n = 29
20 9
Occlusions Stenoses
8.2 6.3
5 Occlusions 9 Stenoses
2.1 4.3
Proximal SFA n=8
Popliteal n = 14 Summary: 28 Iliac arteries 89 SFA/pop
65 Occlusions 52 Stenoses
2.0 0.9
Severity of daudication~ 2 Mild 8 Moderate 2 Severe 1 Mild 6 Moderate 1 Severe 1 Mild 4 Moderate 2 Severe 6 Mild 15 Moderate
Critical degree of ischemia~
Immediate results
Early results (12 weeks)
3
All successful
All successful
2
All successful
11 Successful 1 Failure
2
7 Successful 1 Failure
6 Successes 2 Failures
12
34 Successes 4 Failures
29 Successes 9 Failures
9 Severe 3 Mild 8 26 Successes 12 Moderate 3 Failures 5 Severe 1 Mild 6 13 Successes 2 Moderate 1 Failure 4 Severe 70 patients with 25 patients with acute 86 Successes claudication ischemia 9 Failures
17 Successes 12 Failures 8 Failures 6 Failures 65 Successes 30 Failures
~SFA indicatessuperficialfemgralartery. tListed by segments in total o f 70 patients With claudication and 25 patients with critical ischemia. Moderate claudication denotes ability to walk 2 blocks, less distance is severe, and more is mild daudication.
femoral artery (CFA) were followed by the insertion of an 8.0 or 9.0F introducer sheath into either the iliac artery or SFA. Patients were then anticoagulated with 5000 units of intravenous heparin. Intraoperative angiography was carried out to document the site and extent of the lesion with the use of a C-arm. Under fluoroscopic control, a guide wire was advanced through the lesion wherever possible. Subsequent hot-tip angioplasty was performed over the guide wire with continuous motion to pre• znt arterial wall perforations. Open surgical exposure of the CFA was carried out when specific indications were present. The technique involved the use of a Trimedyne (Santa Ana, Calif.) Nd:YAG laser source and delivery through a 2.5 mm laser probe advanced transluminally to the lesion. Twelve to 14 W of energy were delivered to the metal tip of the probe. Once an appropriate channel had been created, conventional balloon angioplasty was performed as a completion adjunct. RESULTS Failures were classified as immediate or shortterm. Immediate failures comprised those cases in which the recanalization procedure proved technically unfeasible or failed within 24 hours. There were rline (9.5%) immediate failures. Follow-up ranged from 1 to 6 months with a mean of 3.2 months.
Short-term failure within this time period occurred in 21 patients (22%). Overall, 30 of 95 patients (31.5%) had an unsuccessful outcome. Only one of these patients was made worse by a failed TLAA. Success was defined by three criteria: angiographic recanalization or luminal enlargement, symptomatic improvement with increased walking ability, and the increase of at least 0.1 in the Doppler systolic pressure ratio at a segment immediately below the angioplasty site: The 65 patients (68.5%) categorized as having a successful TLAA had angiographic confirmation of anatomic patency coupled with improvement or resolution of claudication and noninvasive documentation of improved arterial flow to the limb. Complications related to the procedure included formation of a groin hematoma in 20 of 52 patients undergoing percutaneous TLAA (38%). However, surgical evacuation was required in only one of these cases. Healing difficulties (minor dehiscence or superficial infection) occurred in three of the 43 open procedures (7%). The average hospital stay (1 to 5 days) was prolonged by 1 day in patients having an open surgical access. Laser probe perforation of the SFA/popliteal artery was noted during the performance o f the laser recanalization in three patients. None required surgical intervention. No iliac perforations occurred during the study period. No instance of clinically significant embolization, limb
534 Criado et al.
Table II. Indication for femoral cut-down Severe lesion in the common femoral artery Severe stenosis in the proximal superficial femoral artery Very obese individuals Situations requiting post-procedure anticoagulation
loss, or death occurred in any of the patients in this series. DISCUSSION Initial clinical experience 3-5 with a laser-heated, metallic-capped, fiberoptic catheter suggests that TLAA is a safe technique. In addition, recurrent stenosis after thermal laser recanalization of experimental arteriosclerosis in animals appears to be less than after balloon dilations. 6 However, early clinical trials assessing laser recanalization of SFA or popliteal arteries have been disappointing. 7 Although initial channels can be created through areas of complete arterial occlusion in up to 90% of patients, clinically successful recanalization can be accomplished only approximately 50% of the time. Clinical success has been improved by adding balloon dilation to thermal angioplasty as reported by Myler et al. 8 and Abela et al. 9 It appears that this combination of laser recanalization and balloon dilation gives optimal resuits at present and was therefore used in this group of patients. Nevertheless, TLAA remains a somewhat controversial therapeutic modality. Definition of patient selection and uncertainties regarding durability are among the key concerns. It would appear safe to state that this is a technique, similar to other transluminal interventions, aimed primarily at the patient with claudication who can be demonstrated to have a favorable iliac or SFA/popliteal lesion, that is, those atherosclerotic occlusions that are 5 cm in length or less and lack extensive calcification. Longer, more heavily calcified lesions, and distal infrapopliteal occlusions are not generally amenable to successful TLAA in its current form. Our results are in line with such contentions (Table I). Our failures were largely in distal SFA lesions that were obstructed. Close evaluation of these patients has taught us that obstructions of the SFA longer than 7 cm are very likely to not respond well to laser-assisted balloon angioplasty~ This subset of patients should either remain untreated or undergo standard femoral-popliteal bypass grafting. However, future innovations in laser technology may very well alter our approach. C a s e selection and evaluation must include objective hemodynamic testing if meaningful assessment is to be obtained. Our follow-up protocol con-
Journal of VASCULAR SURGERY
sists of clinical assessment and hemodynamic evaluation by Doppler segmental pressures at 24 hours, 2 weeks, and every 3 months thereafter. All patients are maintained on aspirin 325 mg daily beginning within 48 hours before the procedure. The group of patients who were classified a success in this series clearly had a hemodynamic improvement in arterial flow to the limb. Conversely, the 31.5% of patients who had an unsuccessful outcome either failed immediately (9.5%) or within several months of the procedure (22%). This latter patient subgroup was readily identifiable because they complained of recurrence of claudication when seen in follow-up at the office. It is also very important to note that only one patient was worsened by a failed TLAA. This patient became severely ischemic 7 weeks after TLAA and required a bypass placement to achieve limb salvage. It is fair to assume that the failed TLAA adversely affected the natural history o f claudication in this particular patient. As such, this comp!icatior~As both serious and notable. Groin hematomas were the most frequent complication occurring in 38% of percutaneous cases. This rate seems quite high and has not been reported as such by our radiology or cardiology colleagues. Our criteria for hematoma were quite strict, and this may account for our high incidence. Any patient who was noted to have a solid lump in the groin larger than 3 cm in diameter was included in this group. Patients often complained of pain over the groin associated with these small hematomas. Resolution usually took place within 4 to 6 weeks of the procedure. Only one patient required surgical exploration to evacuate the hematoma and arrest hemorrhage. We have learned that formation of a hemator~_. can be lessened by not removing the introducer sheath until the patient has been in the recovery room for approximately i hour after the termination of the procedure. Surgical approach to the CFA obviates formation of a hematoma as a complication, but other problems involving healing difficulties arose in 7% of cases. It does appear clear that there are clear-cut indications for "cutting down" on the artery, and these are listed on Table II. As expected, a surgical incision will prolong hospital stay, but only by 1 day. In summary, the approach strategy is most critical. Percutaneous procedures have tremendous appeal, but because a size 8F or larger introducer sheath is required a groin hematoma develops frequently. However, in most cases the hematoma does not alter outcome, and surgical evacuation is very seldom nec~ essary. , W e have seen no instances of formation ol
Volume 11 Number 4 April 1990
p s e u d o a n e u r y s m at the puncture site. Proper technique and timing o f sheath removal and finger compression o f the femoral artery at the groin are essential if incidence o f this complication is to be minimized. Arterial perforation with extravasation o f contrast material was n o t e d in three patients. All these were in the SFA and n o n e o f the patients required surgical exploration. N o iliac perforation occurred during the study period. Verbal reports f r o m other clinical investigators relate these as being m u c h m o r e serious. W e found the lack o f significant atheroembolization a pleasant surprise. O u r clinical experience with diseased b l o o d vessels suggested that o u r experience w o u l d t u r n o u t differently. Nevertheless, ang i o g r a p h y p e r f o r m e d in the operating r o o m after T L A A failed to show a single case o f embolization. W e n o t e d no clinical evidence o f this potential compl;nation in o u r follow-up o f these patients. Perhaps this lack o f embolization accounts for the fact that no limb loss occurred in this series. Laser p r o b e recanalization finds its best indication in short iliac and m i d SFA occlusions. Stenotic lesions can also be "debulked" with a laser p r o b e tracked Over a wire before balloon dilation. H o w e v e r , the evidence is presently scarce regarding any longt e r m benefits over balloon angioplasty alone. Lastly, it is i m p o r t a n t to note that Seeger et al. :° have estimated that as few as I 0 % to i 5 % o f patients with peripheral vascular disease w o u l d be amenable to laser angioplasty in the lower extemities. Therefore it w o u l d appear that this technology w o u l d have a rather limited clinical application at present.
Laser~balloon angioplasty: An early surgical experience 535
REFERENCES
1. Marcruz R, Martins JRM, Turpinanba AS, et al. Therapeutic possibilities of laser beams in atheromas. Arg Bras Cardiol 1980;34:9-12. 2. White RA, White GH. The current and future role of lasers in vascular surgery. Perspectives in Vase. Surg. 1988;1: 1-20. 3. Sanbom TA, Cumberland DC, Tayler DI, Ryan TJ. Human percutaneous laser thermal angioplasry [Abstract]. Circulation 1985;72:[suppl III]:303. 4. Cumberland DC, Sanborn TA, Tayloer DI, et al. Percutancous laser thermal angioplasty: initial clinical results with a laser probe in total peripheral artery occlusions. Lancet 1986;1:1457-9. 5. Sanborn TA, Greenfield AJ, Guben JK, Menzoian JO, LoGerfo FW. Human percutaneous and intraoperative laser thermal angioplasty: initial clinical results as an adjunct to balloon angioplasty. J Vasc Surg 1987;5:83-90. 6. Sanborn TA, Haudenschild CC, Graber GR, Ryan TJ, Farm DP. Angiographic and histologic consequences of laser thermal angioplasty: comparison with balloon angioplasty. Circulation 1987;25:1281-6. 7. Cumberland DC, Sanborn TA, Taylor DI, et al. Percutaneous laser thermal angioplasty: initial clinical results with a laser probe in total peripheral artery occlusions. Lancet 1986;2: 1457-9. 8. Myler RK, Cumberland DA, Clark DA, Stertzer SH, Tatpati DA, Sarma PKS. High and low power thermal laser angioplasty for total occlusions and restenosis in man. Circulation 1987;76(Suppl IV) :230. 9. Abela FS, Seeger JM, Khoury AI, Jablonski S, Conti CR. Laser recanalization of peripheral arteries of humans. Acute and long term effects. Circulation 1987;76(Suppl IV): 409. 10. Seeger JM, Abela GS, Sitverman SH, Jablonski SK. Initial results of laser recanalization in lower extremity arterial reconstruction. J Vasc Surg 1989;9:10-7.
