VERTOS II: percutaneous vertebroplasty versus conservative therapy in patients with painful osteoporotic vertebral compression fractures; rationale, objectives and design of a multicenter randomized controlled trial.

BACKGROUND: The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is gaining popularity as a new treatment option. Many prospective and retrospective studies have reported on the effectiveness and safety of PV, but no large randomized controlled trial (RCT) has been published. OBJECTIVE: To estimate cost-effectiveness of PV compared to conservative therapy in terms of: pain reduction, quality of life, complications, secondary fractures and mortality. MATERIALS AND METHODS: The VERTOS II study is designed as a prospective, multicenter RCT. Patients with a painful VCF with bone edema on MR imaging, local back pain for 6 weeks or less, osteopenia and aged 50 years or older, after obtaining informed consent are included and randomized for PV or conservative therapy. In total 200 patients will be enrolled. Follow-up is at regular intervals during a 1-year period with standard questionnaires, addressing: clinical symptoms, pain medication, Visual Analogue Scale (VAS) score, quality of life and cost-effectiveness. Secondary fractures, necessary additional therapies and complications are recorded. CONCLUSION: The VERTOS II study is the first methodologically sound RCT designed to assess the cost-effectiveness of PV compared to conservative therapy in patients with an acute osteoporotic VCF. TRIAL REGISTRATION: http://www.clinicaltrials.gov, NCT00232466.

Haemostatic effects of low osmolar non-ionic and ionic contrast media: a double-blind comparative study.

In this prospective, double-blind, randomized study the effects of a non-ionic contrast medium (Iopromide) on the haemostatic system were compared with those of a low osmolar ionic medium (Ioxaglate). The aim was to investigate in vivo whether a non-ionic contrast agent is less anticoagulant or more pro-thrombotic than an ionic medium. A large number of haemostatic parameters, including activation markers, were measured. Either Iopromide (n = 16; median volume 102 ml; 95% confidence interval 90-108 ml) or Ioxaglate (n = 15; median 105 ml; 95% confidence interval 95-114 ml) was given to 31 patients scheduled for abdominal and femoral arteriography. Blood for laboratory investigations was collected before, and 5 and 30 min after, administering the contrast medium. Indications for activation of coagulation and platelets were already found in nearly 50% of the patients before any contrast medium was given. Both Iopromide and Ioxaglate caused further increases in thrombin-antithrombin complex, prothrombin fragments 1 + 2 and beta-thromboglobulin. The degree of activation was similar for both agents. Anticoagulant effects were not observed. The haemorheological effects were compatible with haemodilution by 5-8%, again without differences between the contrast agents. Contrary to the findings from in vitro studies, we found no significant differences between the effects of the non-ionic Iopromide and the ionic Ioxaglate on coagulation and platelets. Both agents activated these systems to a limited, but identical, degree. Our results support the notion that the catheterization procedure per se may represent a source of haemostatic activation and that the ionic contrast agent studied has insufficient anticoagulant effect to prevent clotting activation being induced by the contrast medium.

Intravascular ultrasound predictors of restenosis after balloon angioplasty of the femoropopliteal artery.

OBJECTIVES: To determine intravascular ultrasound parameters related to restenosis following percutaneous transluminal balloon angioplasty (PTA) of the femoropopliteal artery. DESIGN: Prospective study. MATERIALS AND METHODS: Patients were studies with intravascular ultrasound before and after angiographic successful PTA (n = 114). Intravascular ultrasound cross-sections obtained with 1 cm interval in the dilated segment were analysed. A distinction was made between anatomic (duplex scanning) and clinical (Rutherford criteria) restenosis assessed within 1 month and at 6 months after PTA. RESULTS: Intravascular ultrasound predictors of 1 month anatomic outcome were lumen area stenosis after PTA, lumen area increase, plaque area decrease, and area stenosis decrease; predictor of 6 months anatomic outcome was area stenosis after PTA. Multivariate analysis revealed that area stenosis after PTA was the only independent predictor of both 1 and 6 months anatomic outcome. Intravascular ultrasound predictors of 1 month clinical outcome were the presence of hard lesion and the mean arc of hard lesion. Multivariate analysis revealed that the mean arc of hard lesion was the only independent predictor of 1 month clinical outcome. No predictors for 6 months clinical outcome were found. CONCLUSIONS: Intravascular ultrasound can elucidate parameters predictive of restonosis after PTA. The strongest intravascular ultrasound parameter predictive of anatomic restenosis was a large area stenosis after PTA.

Evaluation of directional atherectomy studied by intravascular ultrasound in femoropopliteal artery stenosis.

PURPOSE: To evaluate the role of intravascular ultrasound (IVUS) before and after directional atherectomy (DA) in the treatment of femoropopliteal artery stenosis. METHODS: In 12 patients with 16 stenoses IVUS was performed before and immediately after an angiographically successful DA. This was defined as a diameter reduction (DR) < or = 50%, which was calculated using the minimal lumen diameter compared with the diameter of a nearby "normal" segment. In the presence of residual plaque on IVUS an additional DA was performed. Endpoints studied were DR < or = 30% on IVUS compared with the IVUS findings of the angiographically normal reference segment, or when no additional atherosclerotic material could be removed by further DA passages. RESULTS: Additional DA (mean 1.6 per lesion) had to be performed in all patients. Initial DA increased the cross-sectional free lumen area (FLA) from 3.8 +/- 2.0 mm2 to 8.1 +/- 2.7 mm2 (p = 0.0004). Additional DA increased FLA to 9.3 +/- 2.3 mm2 (p = 0.002) after the second passage and to 9.8 +/- 2.4 mm2 (p = 0.09) after the final DA run. The plaque area (PLA) before DA decreased from 18.1 +/- 4.2 mm2 to 15.4 +/- 4.8 mm2 (p = 0.002) after the first passage, and to 13.5 +/- 5.0 mm2 (p = 0.004) and 12. 8 +/- 4.4 mm2 (p = 0.07) after the second and final DA runs, respectively. PLA of the reference segment (9.5 +/- 5.7 mm2) was significantly smaller (p = 0.006) than the final PLA of the treated lesion, indicating a large amount of retained plaque. As a result of DA there was an increase in the area bordered by the medial layer, i. e., the total vessel area (from 21.9 +/- 4.7 mm2 to 23.0 +/- 4.7 mm2), significantly in eccentric and soft lesions. On IVUS, dissection and plaque rupture after the final passage was seen in 12 of 16 stenoses; two dissections were seen on the completion angiogram. After the final passage in all stenoses except three, the DR with IVUS was < or = 30%. CONCLUSION: Lumen enlargement following DA is predominantly due to plaque excision. Vessel expansion combined with plaque excision varies in different stenoses and is an important factor in eccentric and soft lesions. Despite additional DA considerable plaque remains.

Balloon angioplasty combined with primary stenting versus balloon angioplasty alone in femoropopliteal obstructions: A comparative randomized study.

PURPOSE: To evaluate whether balloon angioplasty combined with stenting (ST) of symptomatic femoropopliteal disease would provide better results compared with balloon angioplasty alone (BA). METHODS: Fifty-one patients were randomized between ST (24 patients) and BA (27 patients). Follow-up comprised clinical and hemodynamic assessment and color-flow duplex ultrasound examinations. RESULTS: Residual stenosis (> or = 30% diameter reduction) occurred in three BA patients, but not in the ST patients. By life-table analysis the cumulative rate of clinical and hemodynamic success after 1 year with ST was 74% (SE 9%) and for those with BA 85% (SE 7%) (p = 0.25). The primary patency at 1 year assessed by color-flow duplex ultrasound was 62% (SE 9%) for ST-treated patients and 74% (SE 8%) for BA patients (p = 0.22). Occlusion occurred in five ST patients (21%) compared with two BA patients (7%). CONCLUSION: ST does not improve clinical and hemodynamic outcome compared with BA. Moreover, the occlusion rate in ST-treated patients is higher.

Patterns of recurrent disease after recanalization of femoropopliteal artery occlusions.

PURPOSE: In this prospective study we investigated the site, occurrence, and development of stenoses and occlusions following recanalization of superficial femoral artery occlusions. METHODS: Recanalization of an occluded femoropopliteal artery was attempted in 62 patients. Follow-up examinations included clinical examination and color-flow duplex scanning at regular intervals. Arteriography was used to determine the localization of the recurrent disease relative to the initially occluded segment. RESULTS: During a mean follow-up of 23 months (range 0-69 months) 14 high-grade restenoses, indicated by a peak systolic velocity ratio >> 3.0, were detected by color-flow duplex scanning. Occlusion of the treated segment occurred in 11 patients. The cumulative 3-year primary patency rate for high-grade restenoses and occlusions combined was 44% (SE 9%). By arteriographic examination the site of restenosis was localized in the distal half of the treated vessel segment in 16 of 21 cases. CONCLUSION: Most restenoses and occlusions occurred during the first year and most disease developed at the previous intervention site. The site of restenosis is more frequently in the distal part of the initially treated segment, a finding that may have therapeutic implications.

Effect of balloon angioplasty in femoropopliteal arteries assessed by intravascular ultrasound.

OBJECTIVE: To study the effects of balloon angioplasty (PTA) of the femoropopliteal artery with intravascular ultrasound (IVUS). MATERIALS AND METHODS: Corresponding IVUS cross-sections (n = 1033) obtained before and after PTA from 115 procedures were analysed. Vascular damage including plaque rupture, dissection and media rupture was assessed. Free lumen area (FLA), media-bounded area (MBA) and plaque area (PLA) were measured. RESULTS: After PTA vascular damage was seen at the target site in 83 (72%) arteries: plaque rupture in 30 (26%), dissection in 66 (57%) and media rupture in 20 (17%) arteries. The FLA increased from 5.4 +/- 3.4 mm2 to 14.1 +/- 5.0 mm2 (p < 0.001), MBA increased from 26.9 +/- 10.0 mm2 to 32.9 +/- 10.7 mm2 (p < 0.001) and PLA decreased from 21.6 +/- 8.5 mm2 to 18.8 +/- 8.0 mm2 (p < 0.001). The increase in MBA accounted for 68% of lumen gain. The frequency of vascular damage and the relative contribution of MBA increase and PLA decrease to luminal gain were not different in procedures with balloon diameter < or = 5 mm and > or = 6 mm. CONCLUSIONS: Vascular damage is common following PTA. Lumen gain is mainly due to vessel expansion and, to a lesser extent, to a decrease in plaque area.

The Günther temporary inferior vena cava filter for short-term protection against pulmonary embolism.

PURPOSE: To evaluate clinically the Günther temporary inferior vena cava (IVC) filter. METHODS: Eleven IVC filters were placed in 10 patients. Indications for filter placement were surgical pulmonary embolectomy in seven patients, pulmonary embolism in two patients, and free-floating iliofemoral thrombus in one patient. Eight filters were inserted from the right femoral approach, three filters from the left. Follow-up was by plain abdominal radiographs, cavography, and duplex ultrasound (US). Eight patients received systemic heparinization. Follow-up, during 4-60 months after filter removal was by clinical assessment, and imaging of the lungs was performed when pulmonary embolism (PE) was suspected. Patients received anticoagulation therapy for at least 6 months. RESULTS: Ten filters were removed without complications 7-14 days (mean 10 days) after placement. One restless patient pulled the filter back into the common femoral vein, and a permanent filter was placed. In two patients a permanent filter was placed prior to removal. One patient developed sepsis, and one an infection at the insertion site. Clinically no recurrent PE developed with the filter in place or during removal. One patient had recurrent PE 7 months after filter removal. CONCLUSION: The Günther temporary IVC filter can be safely placed for short-term protection against PE. The use of this filter is not appropriate in agitated or immunocompromised patients.

Comparison of balloon angioplasty and Simpson atherectomy for lesions in the femoropopliteal artery: angiographic and clinical results of a prospective randomized trial.

PURPOSE: This study involves a prospective randomized trial comparing clinical and angiographic results of balloon angioplasty (BA) and Simpson directional atherectomy (DA) in patients with short lesions in the femoropopliteal artery causing symptoms of intermittent claudication. MATERIALS AND METHODS: Thirty-five patients were treated with BA and 38 with DA. Procedural complications were seen in eight patients. Residual stenoses immediately after the procedure with between 30% and 50% diameter reduction (DR) were observed in three patients after BA and in five patients after DA. In all other patients, residual stenosis was less than 30% DR. Two study end-points during a 2-year follow-up were used: the angiographic occurrence of restenosis with a DR of 50% or greater or the recurrence of symptoms. RESULTS: Clinical success after 2 years, according to the criteria of the Society for Vascular Surgery/International Society for Cardiovascular Surgery, was seen in 79% of the BA patients and 56% of the DA patients (P = .07). The 2-year primary angiographic patency rates were 67% in patients treated with BA and 44% in patients treated with DA (P = .06). The secondary angiographically determined patency rates were 80% and 65%, respectively (P = .15). CONCLUSION: Simpson atherectomy is an interventional technique to treat arterial lesions in the femoropopliteal artery with an acceptably low complication rate. The clinical and angiographic results of DA and BA are comparable. DA should not be used to replace BA for routine treatment of short femoropopliteal lesions.

Stent placement after iliac angioplasty: comparison of hemodynamic and angiographic criteria. Dutch Iliac Stent Trial Study Group.

PURPOSE: To assess the diagnostic value of angiography as a guideline for selective stent placement after percutaneous transluminal angioplasty (PTA) of the iliac artery. MATERIALS AND METHODS: Seventy-nine patients (100 iliac artery lesions) with intermittent claudication were treated with PTA and stent placement if they had a residual intraarterial mean pressure gradient of more than 10 mm Hg across the PTA site. Pre- and post-PTA angiograms were used to determine if stent placement was necessary for improvement of the initial result of PTA. Interobserver agreement was determined by using kappa statistics. Pearson correlation coefficients for the percentage of residual stenosis and the pressure gradient after angioplasty were calculated. Sensitivity and specificity of angiography with regard to secondary stent placement were calculated. RESULTS: Observer agreement on stenosis grade before angioplasty was good (mean kappa, 0.65). Agreement on angioplasty results was fair (mean kappa, 0.45). Agreement on selective stent placement on the basis of angiographic criteria was poor to fair (kappa = 0.21-0.62). Correlation between percentage stenosis and pressure gradient was low (Pearson coefficient, 0.01-0.17). The sensitivity and specificity of angiography were 45% and 63%, respectively. CONCLUSION: Angiography is inadequate for determination of a suboptimal angioplasty result. The decision to perform selective stent placement should be made on the basis of hemodynamic measurements.

The value of duplex surveillance after endovascular intervention for femoropopliteal obstructive disease.

OBJECTIVE: The objective of the present study was to assess prospectively whether serial Duplex examination was useful in identifying impending failure after endovascular interventions of the femoropopliteal arteries. SETTING: Non-university hospital. Prospective clinical study. METHODS: 124 Patients were successfully treated by endovascular procedures during a 5 year period. The follow-up was by colour-flow Duplex examination at fixed intervals. At similar intervals clinical examination, including ankle blood pressure measurement was performed to assess the clinical/haemodynamic status of the patients according to the SVS/NAISCVS guidelines. For the diagnosis of impending failure the Duplex criterion was a peak systolic velocity ratio > 2.5 and the clinical/haemodynamic criterion was a level < +2. Actual failure of the vascular procedure was defined as the occurrence of an occlusion in the treated arterial segment or a recurrent stenosis causing symptoms severe enough to require a reintervention. No prophylactic reinterventions were performed on the basis of abnormal Duplex findings alone. RESULTS: Abnormal Duplex findings indicating restenosis were observed in 52 patients. Duplex abnormalities predicted treatment failure with a sensitivity of 86% and a specificity of 75%, while clinical/haemodynamic assessment had a sensitivity of 93% and a specificity of 90%. The hypothetical management outcome if Duplex surveillance had been used as a basis for reintervention was assessed. It appeared that only one patient with failure would have received a redo endovascular procedure at the time he had a restenosis. CONCLUSIONS: Clinical/haemodynamic assessment was more useful for the follow-up of endovascular interventions than Duplex surveillance.

Comparison of intravascular ultrasonography and intraarterial digital subtraction angiography after directional atherectomy of short lesions in femoropopliteal arteries.

PURPOSE: In this study a group of patients undergoing directional atherectomy for localized occlusive disease in the femoropopliteal arteries, the value of intravascular ultrasonography (IVUS) to improve the efficacy of plaque removal was evaluated. The findings obtained by IVUS were correlated with intraarterial digital subtraction angiography (IA DSA) performed during the procedure. In addition, the patency rates at follow-up in patients undergoing atherectomy with and without IVUS were compared. METHODS: Forty patients were treated by atherectomy because of segmental lesions of the femoropopliteal arteries causing intermittent claudication. Twenty-two patients underwent atherectomy, guided by biplane IA DSA only, and 18 patients were also studied by IVUS. The groups were divided by means of consecutive presentation, IVUS being used in the second part of the study period. The median follow up was 16 months (range, 0 to 40 months). Variables, measured by IVUS during the procedure, were the minimal transverse luminal diameter (MTLD) and the free luminal area. Patency rates at follow-up were determined by regular color flow duplex examinations. Color-flow duplex criteria for occlusions were absence of arterial flow and, for stenosis, a ratio of peak systolic velocities at the diseased segment and a normal segment of 2.5 or greater. RESULTS: Qualitative IVUS assessment prompted additional atherotome passages because of insufficient atheroma removal or nonaesthetic appearance of the vessel lumen in 15 of the 18 patients who underwent this examination. Only in four of these patients would abnormalities at IA DSA have been a reason for further attempts of atheroma removal. As for the quantitative findings during AT, after a first series of atherectomy passes the mean MTLD of the reference lesion resulted in an increase of the MTLD from a mean of 3.3 +/- 0.7 mm to 3.7 +/- 0.6mm (p = 0.001), and the free luminal area increased from a mean of 11.2 +/- 4.8 mm2 to 12.5 +/- 4.5 mm2 (p = 0.001). However the occurrence of restenosis during follow-up was comparable in patients monitored during the intervention by IVUS (1-year patency rate, 57%) and patients not studied by IA DSA only (1-year patency rate, 64%). In addition, the presence of an intimal dissection or a plaque rupture at IVUS examination did not predict restenosis. CONCLUSIONS: The application of IVUS resulted in an improved luminal enlargement by directional atherectomy but not in a better 1-year patency rate.

Congenital pelvic arteriovenous malformation: a rare cause of sciatica.

A patient with a large congenital pelvic arteriovenous malformation presenting with irradiating pain to the leg, most likely due to sciatic nerve compression, is described. Congenital pelvic arteriovenous malformation are rare lesions, especially in males. Diagnosis was established by arteriography and contrast-enhanced computed tomography scan. Surgical resection of the AVM relieved our patient of all symptoms. However, endovascular therapy, either as primary treatment or followed by conventional surgery is the treatment of choice. Pelvic arteriovenous malformations should be considered in the differential diagnosis of unexplained sciatica.

The cost-effectiveness of treatment of short occlusive lesions in the femoropopliteal artery: balloon angioplasty versus endarterectomy.

OBJECTIVE: To compare the short- and long-term outcome and the costs involved in balloon angioplasty (BA) and thromboendarterectomy (EA) of short femoropopliteal occlusions. DESIGN: Retrospective study. PATIENTS AND METHODS: Forty-one lower limbs underwent EA from 1980 until 1988 and BA was performed in 62 limbs between 1988 and 1993. The two groups of patients were well matched for age, gender, cardiovascular risk-factors and the length of the femoropopliteal occlusions. In addition to clinical follow-up colour-Duplex scanning and intraarterial DSA were performed. Complete occlusions or significant restenoses were considered failure of the reconstruction. Actual costs were calculated by the hospital economic administration. RESULTS: The 3-year primary patency in EA patients was 87% and in the BA group 44% (p = 0.0002). Redo procedures were required in seven (17%) patients with EA and in 24 (39%) with BA. Patency after redo procedures, i.e. tertiary patency, was 94% and 74% after 3 years in the EA and BA group respectively (p = 0.14). The mean cost of the primary treatment was higher in EA than in BA patients (p < 0.0001). Mean total treatment costs including the expenses involved with redo procedures were also higher in the group with EA than with BA (p < 0.001). However, the cost-effectiveness expressed as the total costs per month tertiary patency, was not significantly different for the two treatment groups; in patients with EA the ratio of total treatment costs and tertiary patency was NFl 309, and in patients with BA NFl 287. CONCLUSION: Contrary to the general view the expenses associated with surgical treatment are comparable with those of an endovascular procedure, if the costs are expressed as a cost-to-patency ratio.

Recanalization of femoropopliteal occlusive lesions: a comparison of long-term clinical, color duplex US, and arteriographic follow-up.

PURPOSE: To assess the merits of clinical examination, color-flow duplex ultrasound (US), and arteriography in the follow-up of patients who have undergone femoropopliteal artery recanalization for occlusive disease. PATIENTS AND METHODS: Recanalization of the occluded femoropopliteal artery was attempted in 62 patients. Follow- up included clinical examination, ankle-brachial blood pressure measurement, and duplex US scanning at 4-month intervals during the first year, at 6-month intervals during the second year, and one a year thereafter. Failure of recanalization included substantial restenosis or reocclusion of the treated segment. Arteriography was performed at the end of the first year or earlier if recurrence was suspected. Agreement of clinical findings with those of duplex US and those of arteriography was determined with kappa statistics; a kappa value of greater than 0.75 represented excellent agreement. RESULTS: Recanalization was technically successful in 51 patients (82%). Clinical patency was 63% (standard error [SE], 6%) after 1 year, 56% (SE, 7%) after 2 years, and 46% (SE, 9%) after 3 years. When technical failures were included, the patency rate at duplex US was 58% (SE, 6%) after 1 year, 40% (SE, 7%) after 2 years, and 33% (SE, 8%) after 3 years. The patency rate at arteriography was 53% (SE, 7%) after 1 year, 33% (SE, 7%) after 2 years, and 30% (SE, 8%) after 3 years. When arteriographic examination was considered the standard of reference, diagnostic accuracy in the identification of recurrent lesions was 94% at duplex US (kappa = 0.88) and 74% at clinical examination (kappa = 0.51). CONCLUSION: Rates of restenosis or occlusion detected at follow-up with duplex US and arteriography were comparable. However, clinical examination alone helped detect fewer cases of recurrent disease.

Directional atherectomy versus balloon angioplasty in segmental femoropopliteal artery disease: two-year follow-up with color-flow duplex scanning.

PURPOSE: Directional atherectomy is an endovascular interventional technique for excision and removal of obstructive arterial lesions. To evaluate whether atherectomy would provide better results than conventional balloon angioplasty (BA) in symptomatic femoropopliteal disease, a prospective randomized study comparing the early and late outcomes of these techniques was conducted. The rate of restenosis or occlusion was assessed by use of color-flow duplex scanning during the follow-up period. METHODS: Seventy-three patients were randomized between atherectomy (38 patients) and BA (35 patients). All patients had segmental lesions of the femoropopliteal arteries amenable to either technique. The median follow-up duration was 13 months (range 1 to 39). Follow-up comprised regular clinical and hemodynamic assessment and color-flow duplex examinations. Restenosis was defined on the basis of a peak systolic velocity ratio of 2.5 or greater, and occlusion of the treated segment was diagnosed if flow signals were absent, that is, loss of patency. RESULTS: Residual stenoses (> or = 30% diameter reduction) resulted in five patients (13%) undergoing atherectomy and three patients (9%) undergoing BA. At 1 month clinical and hemodynamic improvement by Society for Vascular Surgery/International Society for Cardiovascular Surgery criteria for lower limb ischemia was observed in 34 patients (89%) treated with atherectomy and in 34 (97%) treated with BA. By life-table analysis the cumulative rate of clinical and hemodynamic success at 2 years was 52% in patients treated with atherectomy and 87% in patients treated with BA (p = 0.06). The patency rate at 2 years of treated segments was 34% in the atherectomy group and 56% in patients treated with BA (p = 0.07). In patients with lesions greater than 2 cm, the 1-year patency rate of AT was significantly lower than BA (p = 0.03). CONCLUSIONS: Atherectomy does not result in an improved clinical and hemodynamic outcome. Furthermore atherectomy of segmental atherosclerotic femoropopliteal disease does not result in a better patency rate than BA, and, in lesions with greater length than 2 cm, the atherectomy results are significantly worse.

Shearing of the plastic coating of a hydrophilic guide wire in a right femoropopliteal bypass graft: removal from the contralateral side.

The plastic coating of a hydrophilic guide wire tore off during introduction through a beveled single wall arterial entry needle in a 75 year old male. The sheared piece of coating got stuck in his femoropopliteal bypass. It was removed by means of a modified arterial filter set from the contralateral side. The technique of its removal is described.

Recurrence of stenoses following balloon angioplasty and Simpson atherectomy of the femoro-popliteal segment. A randomised comparative 1-year follow-up study using colour flow duplex.

The results of balloon angioplasty (BA) and atherectomy (AT) with the Simpson atherocath, were compared in a randomised prospective study. Thirty-one patients were randomised to one of these methods for the treatment of symptomatic stenotic or occlusive lesions in the superficial femoral and popliteal arteries. One patient died after randomisation but before the procedure, thus 30 patients were available for analysis. All patients had intermittent claudication and BA was used in 14 and AT in 16 limbs. A surveillance protocol included colour flow duplex scanning of the femoro-popliteal arteries after 6 weeks and then at 3-monthly intervals during the 1st year and every 6 months thereafter. The average duration of follow-up was 9.7 months. For confirmation intra-arterial digital subtraction angiography (DSA) was performed in all patients at 1 year following the intervention, when clinical symptoms occurred or when colour flow duplex indicated greater than 49% restenosis. Three small dissections were the only postoperative complications and residual stenoses greater than 20% diameter reduction (DR) were observed in two patients following BA and in two after AT. Improvement of clinical category according to the "Standards for evaluating results of interventional therapy for peripheral vascular disease" occurred in 13 of 14 BA patients and in 15 of 16 AT patients. Follow-up results were expressed as cumulative patency and clinical success. Endpoints for patency were recurrence of the stenosis at the treated segment or new lesions in different segments and endpoints for clinical success were a drop in clinical category (symptoms, ankle pressure indices and post-exercise ankle pressures). One-year patency (no restenosis greater than 49% DR) was 77% in patients with BA and 25% in patients with AT (p = 0.017).(ABSTRACT TRUNCATED AT 250 WORDS)