| | Popliteal artery volume flow measurement: A new and reliable predictor of early patency after infrainguinal balloon angioplasty and subintimal dissectionPresented at the Sixtieth Annual Meeting of the Society for Vascular Surgery, Philadelphia, PA, Jun 1-4, 2006. Received 6 June 2006; accepted 13 September 2006. published online 29 November 2006. ObjectiveWe have investigated whether popliteal artery volume flow (PAVF) measured immediately after balloon angioplasties of the superficial femoral artery–popliteal segments (SFA/POP) was predictive of early (30 days) and mid-term (6 months) arterial thrombosis. MethodsDuring the last 24 months, 203 patients (56% men) with a mean age of 73 ± 9 years had 268 duplex-guided balloon angioplasties of the SFA/POP. Critical ischemia was the indication in 36%. Group I included 176 (66%) with stenoses, and group II had 92 (34%) with occlusions. All patients had completion duplex examinations that included three measurements of PAVF of below-the-knee popliteal artery. ResultsEarly (30 days) thrombosis of the treated femoropopliteal arterial segment developed in 10 patients (3.7%), three in group I (1.7%) and seven in group II (7.6%; P < .04). All 10 cases of early thrombosis were in patients with TransAtlantic Inter-Society Consensus (TASC) class C (6/185, 3.2%) and D (4/26, 15%) lesions. Moreover, the 19% incidence (n = 4) of early thrombosis in patients with PAVF <100 mL/min (mean, 73 ± 24 mL/min; range, 20 to 99 mL/min) was higher compared with the 2.4% rate for patients with higher flows (mean, 176 ± 60 mL/min; range, 100 to 450 mL/min; P < .01). At 6 months of follow-up, femoropopliteal occlusions had developed in nine more patients, and it became apparent that low PAVF measurements were still predictive of thrombosis (29%) when compared with higher PAVF cases (6%; P < .002). Log-rank comparison of survival curves for cumulative primary stenosis-free patency in group I and group II demonstrated a statistically significant difference (P < .02). PAVF <100 mL/min and TASC classification were significant predictors of early (30 days) and mid-term (6 months) arterial thrombosis after femoropopliteal angioplasties. PAVF was the most powerful predictor of arterial thrombosis. The respective 6-month and 12-month limb salvage rates were 98% and 94% for patients with claudication and 88% and 85% for those with limb-threatening ischemia (P < .0001). ConclusionsOur results demonstrate that low PAVF is the most powerful predictor of early (30 days) and mid-term (6 months) arterial thrombosis after femoropopliteal interventions. In the presence of a low postprocedure PAVF (<100 mL/min), one may consider not reversing the heparin or using intermittent calf compression, or both, to augment the arterial flow. The advent of high-resolution duplex imaging has allowed our group to image the vascular tree from the aorta to pedal vessels with sufficient accuracy to plan out the revascularization without the need for additional imaging modalities.1, 2, 3, 4, 5 More recently, we extended this experience to endovascular procedures. Since then, the role of duplex-guided angioplasties in patients with lower extremity ischemia has been an area of great interest at our institution.6, 7, 8 One of the advantages of using duplex scanning over standard arteriography is the possibility of performing hemodynamic evaluation of the treated arterial segment. Another is the feasibility of measuring volume flows distal to the angioplasty site. It is logical to assume that patients with low volume flow in the below knee popliteal artery after balloon angioplasties of the ipsilateral superficial femoral artery (SFA) are at increased risk of thrombosis compared with patients with higher volume flows. In an attempt to validate this hypothesis, we prospectively evaluated the role of popliteal artery volume flows (PAVF) after angioplasty as a potential predictor of early arterial thrombosis. We also compared several other potential indicators of early success or failure after angioplasty, including the presence of critical limb ischemia, diabetes mellitus, runoff score, and TransAtlantic Inter-Society Consensus (TASC) classification. Methods  Patients During the last 24 months at our institution, 203 patients had 268 duplex-guided balloon angioplasties of the superficial femoral or popliteal arterial segment, or both, on 226 limbs. The series included 114 men (56%) and 89 women (44%), and their mean age was 73 ± 9 years (range, 42 to 97 years). Concomitant risk factors were hypertension in 160 patients (79%), diabetes mellitus in 99 (49%), smoking in 87 (43%), and coronary artery disease in 79 (39%); in addition, 71 (35%) had elevated serum creatinine levels (≥1.5 mg/dL). Indications for the procedure were claudication in 172 (64%), rest pain in 17 (6%), ischemic ulcers in 53 (20%), and gangrene in the remaining 26 (10%). Preoperative evaluation Preoperative duplex arteriography was performed in all patients by an experienced registered vascular technologists according to a protocol previously published by our group.1, 2 Imaging findings were confirmed by physiologic examinations, including pulse volume recordings and ankle-brachial indices (ABIs). If ABIs were unavailable owing to nonaudible pulses or noncompressible calcified arteries, we recorded ankle tracings amplitude. Duplex arteriography showed a severe stenosis or occlusions, or both, in the superficial femoral artery (SFA) or popliteal artery, or both, in all cases. Group I included 176 cases (66%) with severe arterial stenoses defined as a diameter reduction of ≥70% measured on color or power image and confirmed by a peak systolic velocity step-up of >3. Of these, 127 were primary cases and 49 were restenoses. Group II had 92 cases (34%) with arterial occlusions; 86 of these were primary cases and six were reocclusions. Femoropopliteal lesions were classified using TASC criteria. There were 17 class A lesions (6%), 40 class B (15%), 185 class C (69%), and the remaining 26 (10%) were class D. An average of 2.2 ± 0.85 patent nondiseased infrapopliteal arteries was found for all patients. There were 126 cases (47%) with all three infrapopliteal arteries patent and without significant stenoses (>50%), 81 (30%) with two arteries, 54 (20%) with one artery, and in the remaining seven (3%), all three arteries were severely diseased or occluded. Technique All procedures were duplex-guided balloon angioplasties performed in the operating room using a technique described in previous publications.6, 7, 8 A Philips HDI 5000 duplex scanner with SonoCT feature (Philips Medical Systems, Bothell, Wash) was routinely used. The approach was antegrade through the common femoral artery (CFA) in 242 cases (90%) and through the contralateral CFA in the remaining 26 (10%). Contralateral CFA access required ipsilateral common iliac artery cannulation under fluoroscopy alone in four cases and with 10 mL to 20 mL of contrast in the remaining 22. Visipaque (Amersham Health, Princeton, NJ) was used in 18 cases and Magnevist (Berlex Laboratories, Wayne, NJ) in the remaining four. Immediately before prepping and draping the patient, we confirmed preoperative duplex findings and marked the stenotic and occlusive arterial lesions on the skin. In addition, we measured PAVF using color duplex imaging and spectral analysis behind the knee three times and recorded an average value. Volume flow was obtained with the Doppler angle adjusted at 60° and the sample volume equal or larger than the arterial lumen. Mean values ± SD and ranges were reported. A sample of PAVF was recorded three times immediately after completion of the procedure and immediately after the intra-arterial administration of 30 mg of papaverine sulphate. Biplanar scanning of the femoropopliteal arterial segment was performed at the completion of the procedure in all cases. Hemodynamically significant residual defects (plaque dissections and recoils) causing diameter reduction of >30% and a peak systolic velocity ratio of >2 were stented with a variety of self-expandable stents under duplex guidance. Duplex assessment of the tibioperoneal trunk and all three infrapopliteal arteries was performed at the end of the procedure in all cases. Postprocedure evaluation and follow-up Arterial duplex pulse volume recordings, including ABIs, were obtained in all patients before hospital discharge and during regular postprocedural follow-up visits in the outpatient office ≤1 month and every 3 months thereafter. Recurrent stenosis was defined as an arterial diameter reduction ≥70% measured by color Doppler imaging and confirmed by a local peak systolic velocity step-up of >3. Arterial occlusion was confirmed by absence of color or power signal in the arterial lumen. Statistical analysis Fisher’s exact test was used to compare the incidence of low PAVF in group I and group II, incidence of 30 day and 6-month arterial thrombosis for group I and group II, and lower and higher PAVF. The paired t test (parametric distribution) was used to compare preprocedure, postprocedure, papaverine-induced PAVF, and ABIs and forefoot pulse volume recording tracings before and after angioplasty. The same analysis was used to compare PAVF for patients with poor (0 to 1 arteries) vs good (2 to 3 arteries) runoff. The statistical software Instat 3.06 (GraphPad Software, San Diego, Calif) for Windows (Microsoft Corp, Redmond, Wash) was used for these calculations. Arterial patency life tables (Kaplan-Meier survival test and log-rank comparison of the survival curves) for group I and group II, patients with claudication vs patients with critical limb ischemia, and different TASC classified lesions were calculated using GraphPad Prism 4.00 (GraphPad Software). Similar analysis was performed for calculation and comparison of limb salvage rates in patients with claudication and critical limb ischemia. Multiple linear regression analysis of five potential independent factors contributing to early (30 days) and mid-term (6 months) arterial thrombosis, (1) PAVF <100 mL/min, (2) TASC classification, (3) run-off score, (4) critical limb ischemia as an indication for intervention, and (5) presence of diabetes mellitus, was performed using the Unscrambler 9.6 software (CAMO Software Inc, Woodbridge, NJ). Results Technical defects and stenting An average of 1.6 ± 0.9 stents (range, 1 to 5 per case) were placed for treatment of residual lumen defects in 172 (64%) of the 268 cases. The reasons for stenting were plaque recoil in 90 (52%), dissection in 42 (25%), or both in 40 (23%). Comparison of preoperative and intraoperative popliteal artery volume flow The mean preoperative PAVF for all patients was 60 ± 28 mL/min (range, 6 to 149 mL/min). In these patients, the postintervention mean baseline PAVF was 169 ± 65 mL/min (range, 20 to 450 mL/min), an increase that was statistically significant (P < .001). All patients demonstrated a PAVF increase after the intra-arterial infusion of 30 mg of papaverine. The mean PAFV increase was 388 ± 213 mL/min (range, 90 to 1350 mL/min), or 134% ± 92% (range, 13% to 567%), which was statistically significant (P < .001). However, the increase of PAVF noted after papaverine administration was not a significant predictor of early arterial thrombosis (P = .30). Correlation of arterial patency with postangioplasty popliteal artery volume flow In 21 (7.8%) of the 268 cases, the baseline mean PAVF was <100 mL/min (mean, 73 ± 24 mL/min; range, 20 to 99 mL/min). Of these, 16 were in the group of 176 transluminal angioplasty cases (9%), and the remaining five (5.4%) were from the 92 subintimal angioplasty cases (P = .30). Early (<30 days) thrombosis developed in the treated femoropopliteal arterial segment in 10 patients (3.7%), of which three were from group I (1.7%) and seven (7.6%) were in group II (P < .04). The incidence of early thrombosis was 19% in patients with PAVF <100 mL/min (n = 4) and 2.4% (n = 6) when higher flows were recorded (P < .01). At the 6-month follow-up, femoropopliteal occlusions developed in 9 more patients, and it became apparent that low PAVF measurements were still predictive of thrombosis (29%) compared with higher PAVF cases (6%; P < .002). Log-rank comparison of survival curves for patency in group I and group II demonstrated a statistically significant difference (P < .02). Correlation of postangioplasty popliteal artery volume flow and infrapopliteal runoff Patients with poor runoff (0 to 1 patent arteries) had a mean PAVF of 153 ± 75 mL/min, and patients with better runoff (2 to 3 patent arteries) had a mean PAVF of 173 ± 62 mL/min (P < .04). Multivariate linear regression analysis of factors predictive of postprocedure arterial thrombosis PAVF <100 mL/min was found to be the most powerful predictor of early (30 days) and mid-term (6 months) arterial thrombosis after femoropopliteal balloon angioplasties. Corresponding data are listed in Table V and Fig 1, Fig 2. Adjunctive infrapopliteal angioplasties Adjunctive infrapopliteal artery angioplasties were required in 49 cases (18%) in this series in an attempt to improve run-off. Of these, 28 (29%) were in the group of 96 patients with critical limb ischemia, and 21 (12%) were in the group of 172 patients with claudication. This difference was statistically significant (P < .009). The mean PAVF of 153 ± 64 mL/min in 49 cases with infrapopliteal angioplasties was not significantly different from the mean PAVF of 172 ± 66 mL/min in the remaining 219 cases without infrapopliteal angioplasties (P = .06). The comparison of cumulative primary stenosis-free patency rates for patients with and without infrapopliteal angioplasties is presented in Table VI. Comparison of balloon angioplasties for primary stenoses and restenoses The mean PAVF was 169 ± 61 mL/min after 127 primary angioplasties and 165 ± 57 mL/min in 49 angioplasties for restenoses (P = .70). The mean PAVF was 385 ± 196 mL/min after administration of papaverine in primary angioplasties and 381 ± 217 mL/min in redo angioplasties (P = .90). The comparison of cumulative primary stenosis-free patency for patients with angioplasties for primary stenoses and redo angioplasties is represented in Table VII. Comparison of preoperative and postoperative ankle-brachial indices or pulse-volume recordings Of the 268 successful angioplasties, reliable ABIs were obtained before and after the procedure in 223 cases (83%). Ankle pulse-volume recordings amplitude tracings were available for comparison in 45 remaining cases (17%). In the latter cases, ABIs were considered unreliable owing to severely calcified noncompressible arteries in 25 or nonaudible pulses in 20. Overall mean ABIs for the 223 patients were 0.68 ± 0.14 (range, 28 to 0.98) preprocedure and 0.93 ± 0.12 (range, 0.55 to 1.23) postprocedure (P < .0001). The mean ankle tracings amplitude was 3 ± 2 mm (range, 0 to 10 mm) before the procedure and 9 ± 4 mm (range, 2 to 21 mm) after for the 45 cases (P < .0001). In 203 patients (91%), a significant increase of ABI of ≥0.15 was demonstrated after angioplasty. Discussion The results of the present study indicate that PAVF measurements are reliable predictors of early thrombosis after infrainguinal balloon angioplasty and subintimal dissection. Indeed, low-flow PAVF (<100 mL/min) is a more powerful predictor than the number of runoff vessels, TASC classification, presence of diabetes mellitus, or the indication for the procedure. This was observed at 1 month and confirmed at 6 months after the intervention. It is important to emphasize that the data analyzed here specifically evaluate arterial thrombosis and not restenosis. We have previously shown that increased outflow resistance values measured intraoperatively were reliable predictors of infrainguinal bypass graft success or failure as well as limb salvage. In our previous experience, these measurements were found to be more predictive than the number of patent outflow vessels.9, 10, 11, 12, 13, 14, 15, 16, 17 Thus, it is not surprising that low PAVFs correlated with an increased likelihood of arterial thrombosis after interventions. Other investigators have correlated early failures of angioplasty with distal runoff and degree of ischemia.18, 19, 20 In our data, the number of runoff vessels was only predictive at 6 months after the procedure. Perhaps this criterion may become significant with an increased experience. Our study is unique in that we confirmed the adequacy of the procedure in all cases by completion duplex scanning examinations. These included visualization of the treated arterial segment and the outflow tract with B-mode, color Doppler, and power-angio, as well as waveform spectral analysis. The latter included measurements of peak systolic velocities and velocity ratios whenever indicated. Accordingly, significant residual stenosis and dissections, as well as distal embolization as potential causes of early thrombosis, were effectively ruled out in all cases. During this experience, we noted discrepancies between fluoroscopy and duplex guidance for the endovascular procedures.21 Although angiography provides excellent anatomic details, it is recognized that scant hemodynamic information is obtained. Well-documented drawbacks of contrast-based procedures include misinterpretations of pseudo-occlusions, lack of visualization in the presence of metal prostheses, radiation, nephrotoxicity, and allergy to the contrast medium. Because hemodynamic information can be obtained with duplex imaging, a high velocity or low volume flow can prompt further examination for a missed defect that may not have been detected by standard arteriography. This is particularly important because biplanar or rotational arteriography is not widely used at the present time to confirm the adequacy of the technique. Some authors have suggested that routine completion duplex examinations be performed after fluoroscopically guided balloon angioplasty.22 Because much of the intervention in the fluoroscopic examination is based upon subjective criteria, we suggest that objective indicators be acquired by duplex scanning. For example, a comparison of preoperative and postoperative volume flows offers an objective way to quantitate the effectiveness of the revascularization in the periprocedural period. When an area of borderline stenosis is detected in the SFA, one may choose to rely on volume flows as a guide for reintervention; of course, this needs to be proven with prospective studies. Although prior reports have already determined the feasibility of performing ultrasound-guided interventions,23, 24, 25, 26, 27, 28 our experience suggests that hemodynamic data may provide an additional advantage compared with contrast-based procedures. We have confirmed the importance of the TASC classification as a reliable predictor of arterial patency after balloon angioplasty29; however, this classification was not as powerful as PAVF in our series. We recognize that causes other than low flow could have influenced these results, including hypercoagulable states, embolization from a more proximal source, or early formation of intimal hyperplasia, or a combination of these. Although these factors were not investigated in the present series, they seem less likely to overcome the predictive power of low PAVF. The overall major amputation rate of 0.9% in the present series is similar to the rates published in other studies. As expected, this rate was higher for the patients who presented with limb-threatening ischemia (2.5%) compared to the patients with claudication (0%).29, 30, 31 The question of how to proceed when a low postprocedure volume flow in the popliteal artery is encountered in the absence of significant arterial defects or stenoses is challenging. Several options are possible: (1) consider not reversing the heparin at the end of the procedure, (2) continue anticoagulation for the long-term, (3) use intermittent calf compression to augment the arterial flow,32 and (4) perform adjunctive balloon angioplasties of the runoff vessels to augment flow in the popliteal artery. These suggestions have not yet been proven, and a larger experience is necessary before this protocol should be implemented. Conclusion We describe a new predictive factor for early (30 days) and mid-term (6 months) arterial thrombosis after balloon angioplasty of the femoropopliteal segment. As the number of endovascular procedures continues to rise, it is necessary to investigate new variables that can reliably predict the patency of these reconstructions. Author contributions Conception and design: EA, AH, NM Analysis and interpretation: EA, AH, NM Data collection: AH, NM Writing the article: EA, AH, NM Critical revision of the article: EA, AH, NM Final approval of the article: EA, AH, NM Statistical analysis: NM Obtained funding: Not applicable Overall responsibility: EA References 1. 1Ascher E, Mazzariol F, Hingorani A, Salles-Cunha S, Gade P. The use of duplex ultrasound arterial mapping as an alternative to conventional arteriography for primary and secondary infrapopliteal bypasses. Am J Surg. 1999;178:162–165. Abstract | Full Text |
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2. 2Ascher E, Markevich N, Schutzer RW, Kallakuri S, Hou A, Nahata S, et al. Duplex arteriography prior to femoral-popliteal reconstruction in claudicants: a proposal for a new shortened protocol. Ann Vasc Surg. 2004;18:544–551. Abstract | Full Text |
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3. 3Ascher E, Hingorani A, Markevich N, Yorkovich W, Schutzer R, Hou A, et al. Role of duplex arteriography as the sole preoperative imaging modality prior to lower extremity revascularization surgery in diabetic and renal patients. Ann Vasc Surg. 2004;18:433–439. Abstract | Full Text |
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4. 4Ascher E, Hingorani A, Markevich N, Schutzer R, Kallakuri S. Acute lower limb ischemia: the value of duplex ultrasound arterial mapping (DUAM) as the sole preoperative imaging technique. Ann Vasc Surg. 2003;17:284–289. Abstract | Full Text |
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5. 5Ascher E, Hingorani A, Markevich N, Costa T, Kallakuri S, Khanimoy Y. Lower extremity revascularization without preoperative contrast arteriography: experience with duplex ultrasound arterial mapping in 485 cases. Ann Vasc Surg. 2002;16:108–114. Abstract |
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6. 6Ascher E, Marks NA, Schutzer RW, Hingorani AP. Duplex-guided balloon angioplasty and stenting for femoropopliteal arterial occlusive disease: an alternative in patients with renal insufficiency. J Vasc Surg. 2005;42:1108–1113. Abstract | Full Text |
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7. 7Ascher E, Marks NA, Hingorani AP, Schutzer RW, Nahata S. Duplex-guided balloon angioplasty and subintimal dissection of infrapopliteal arteries: early results with a new approach to avoid radiation exposure and contrast material. J Vasc Surg. 2005;42:1114–1121. Abstract | Full Text |
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28. 28Ugurluoglu A, Katzenschlager R, Ahmadi R, Atteneder M, Koppensteiner R, Lang G, et al. Ultrasound guided compression therapy in 134 patients with iatrogenic pseudo-aneurysms: advantage of routine duplex ultrasound control of the puncture site following transfemoral catheterization. Vasa. 1997;26:110–116. MEDLINE 29. 29Surowiec SM, Davies MG, Eberty SW, Rhodes JM, Illig KA, Shortell CK, et al. Percutaneous angioplasty and stenting of the superficial femoral artery. J Vasc Surg. 2005;41:269–278. Abstract | Full Text |
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30. 30Gray BH, Sullivan TM, Childs MB, Young JR, Olin JW. High incidence of restenosis/reocclusion of stents in the percutaneous treatment of long-segment superficial femoral artery disease after suboptimal angioplasty. J Vasc Surg. 1997;25:74–83. Abstract | Full Text |
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31. 31Lipsitz EC, Ohki T, Veith FJ, Suggs WD, Wain RA, Cynamon J, et al. Does subintimal angioplasty have a role in the treatment of severe lower extremity ischemia?. J Vasc Surg. 2003;37:386–391. Abstract |
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Maimonides Medical Center, Division of Vascular Surgery, Brooklyn, NY.  Reprint requests: Enrico Ascher, MD, Maimonides Medical Center, 4802 10th Ave, Brooklyn, NY 11219.
Competition of interest: none. PII: S0741-5214(06)01747-2 doi:10.1016/j.jvs.2006.09.042 © 2007 The Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. | |
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