Abstract
Purpose:
Percutaneous lower extremity revascularization is being performed via upper extremity, pedal, or popliteal access with increasing frequency. This study aimed to compare periprocedural outcomes of popliteal (POA) and upper extremity (UEA) access for the treatment of isolated superficial femoral artery (SFA) occlusive disease.
Materials and Methods:
A retrospective cohort study compared the outcomes of patients undergoing primary percutaneous intervention of SFA occlusive disease with POA or UEA using the Vascular Quality Initiative database from December 2010 to June 2019. Our primary endpoint was technical success. Secondary endpoints included factors associated with perioperative complications.
Results:
A total of 349 patients underwent isolated SFA intervention through the popliteal, radial, or brachial artery. UEA was performed in 188 (53.9%) patients and POA in 161 (46.1%). Technical success with TASC A lesions was 95.8% and with TASC D lesions, 65.0%. POA had a higher proportion of TASC D lesions (24.8% vs 10.6%, p<0.001), and larger (≥7 Fr) sheath size (14.3% vs 2.7%, p<0.001). UEA had a higher proportion of no calcification (27.1% vs 11.2%, p<0.001), and smaller (4–5 Fr) sheath size (46.8% vs 34.8%, p=0.023). There was no difference in technical success between UEA and POA (88.8% vs 84.5%, p=0.230), which was also seen on multivariable analysis (p=0.985). Univariate analysis revealed technical failure was associated with TASC D lesions (45.7% vs 12.9%, p<0.001) and the presence of severe calcifications (39.1% vs 17.5%, p=0.002). Multivariable analysis confirmed technical failure was associated with degree of calcification (OR, 2.4; 95% CI, 1.18 to 4.89; p=0.016) and TASC D lesions (OR, 5.01; 95% CI, 2.45 to 10.24; p<0.001). Postoperative complications were associated with UEA on univariate (p=0.041) and multivariate analysis (OR, 2.08; 95% CI, 0.80 to 5.37; p=0.016). Access site complications were also associated with UEA compared to POA (4.3% vs 0.0%, p=0.027).
Conclusions:
There is no difference in technical success between UEA and POA when treating isolated SFA occlusive disease, and UEA is associated with a higher complication rate. Technical success is dependent on calcification and TASC II classification. Based on similar technical success rates and low complication rates, POA should be considered as a viable alternative to UEA when planning endovascular interventions.
Keywords
Introduction
With the increased sophistication of endovascular devices and techniques over the past 2 decades, percutaneous approaches have increasingly become the first choice for superficial femoral artery (SFA) revascularization.1–5 While arterial access is typically achieved through a contralateral or ipsilateral puncture of the common femoral artery, multiple factors preclude its use as the arterial access point. This includes prior abdominal aortic aneurysm repair, iliac tortuosity, severe aortoiliac femoral occlusive disease, ostial SFA occlusion without a stump, absent femoral pulses, and reluctance among interventionalists to access a femoral artery on the same side as an ipsilateral femoral bypass or other obstruction of the groin(eg, morbid obesity, infection, hematoma, trauma, scarring).6–9 In these cases, when the conventional femoral approach is impractical, radial, brachial, popliteal, and pedal access have been shown to be viable alternatives.6–8,10 Direct comparisons of these approaches have not been conducted in the context of lower extremity occlusive disease, and there is a lack of guidance to suggest the preferred alternative access site for SFA occlusive disease.1,4,10
Upper extremity access (UEA), through the radial or brachial artery, and popliteal access (POA) have been frequently used for endovascular interventions. Multiple studies in recent years have demonstrated that both UEA and POA are practical alternatives to femoral access in terms of complication rates and technical success.7,10–12 Both also offer the ability for early ambulation.7,8 Though UEA may offer an advantage when treating bilateral lesions, the distance of the UEA access site from the lower extremity lesions hampers equipment selection, decreases pushability and torquability, and introduces constraints presented by tortuosity and calcification of the aortic and subclavian arteries.6,7,10,13,14 In contrast, the use of retrograde POA has been noted to provide superior pushability and torquability in comparison to femoral access and may facilitate easier crossing of lesions through the softer distal cap of the occlusive atherosclerotic plaque.9,11–13,15 Recent improvements in technique have also decreased the rates of complications associated with early POA attempts.9,16 However, the lack of a standardized POA protocol; inherent risks associated with the prone position; and difficulties associated with accessing a flexed leg, compressing the vessel after sheath removal, and obesity complicate the POA approach.9,11,16
Given the current lack of comparisons in the literature, we aimed to compare the technical success and complication rate of UEA and POA for the treatment of isolated SFA occlusive disease to help guide selection of the preferred alternative access site. We hypothesize that POA for isolated SFA occlusive disease results in a higher degree of technical success and a lower complication rate.
Materials and Methods
A retrospective cohort study was performed using the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) registry. The VQI is a prospectively maintained database consisting of >150 variables of commonly performed endovascular and open procedures performed in the United States and Canada. This study was approved by the SVS VQI Research Advisory Committee and the Institutional Review Board of Northwell Health (IRB# 15-378), and the need for consent of individual patients was waived.
Using the VQI registry, patients who underwent percutaneous intervention for isolated SFA occlusive disease via single site brachial, radial, or popliteal access between December 2012 and June 2019 were identified. Patients with multiple access sites or acute limb ischemia were excluded from the analysis. Due to the low number of patients, those whose arterial access was obtained through the brachial or radial artery were categorized into a single UEA group. Patient demographics, relevant comorbidities, TransAtlantic Inter-Society Consensus (TASC) II lesion classification, subjective rating of the degree of calcification, operative details, and perioperative outcomes were retrieved from the registry. Calcification is documented in the VQI as none (no calcification visible on fluoroscopic, computerized tomography, or intravascular ultrasound imaging), focal (calcification on one side of the artery, less than half the lesion length), mild (one side, greater than half the lesion length), moderate (both sides of the artery, less than half the lesion length), and severe (both sides of the artery, greater than half the lesion length).
The primary outcome of this study was technical success, defined as residual stenosis ≤30%, between the UEA and POA groups. Secondary endpoints included factors associated with peri-operative complications. Access site complications included hematomas, stenosis/occlusions, infections, pseudoaneurysms, and arterio-venous fistulas.
Continuous data were summarized as means and standard deviations whereas categorical data were reported as counts and percentages. Patient characteristics and operative details of the UEA and POA groups were compared using the Wilcoxon signed rank test for continuous data and either the chi-square or Fischer’s exact test for categorical data. Technical success of the UEA and POA groups was compared using a simple logistic regression model. To identify factors associated with technical failure compared with technical success, a univariate regression, followed by a multivariate logistic model to control for potential confounding factors, was used. Similarly, both univariate and multivariate analysis were used to identify factors associated with perioperative complications compared with no complications. A subgroup analysis comparing the rate of complications among the brachial and radial subgroups was also performed; however, due to the distribution of data, only descriptive analysis was performed. Results were considered to be statistically significant at p<0.05, unless otherwise specified. Analyses were performed using SAS 4.4 software (SAS Institute, Cary, NC).
Results
Between December 2012 and June 2019, a total of 349 patients underwent isolated SFA intervention through the popliteal, radial, or brachial artery. POA was performed in 161 (46.1%) patients and UEA in 188 patients (53.9%). Mean age was 67.0 (±9.9) years, and 65.8% of patients were male. Demographic data, comorbidities, and operative characteristics are summarized in Table 1. The POA cohort had a higher proportion of males (77.0% vs 54.3%; p<.001), history of diabetes (59.6% vs 39.9%; p<.001), TASC II class D lesions (24.8% vs 10.6%; p<.001), and use of sheath size 7-Fr or greater (14.3% vs 2.7%; p<.001). The UEA cohort had a higher proportion of lesions without calcification (27.1% vs 11.2%; p<.001) and use of sheaths size 4–5-Fr (46.8% vs 34.8%; p=0.023). There were no differences between the POA and UEA cohorts in terms of body mass index (BMI), smoking history, dialysis, coronary artery disease, or congestive heart failure.
Patient Demographics and Operative Characteristics. a
Abbreviations: BMI, body mass index; CAD, coronary artery disease; CHF, congestive heart failure; IQR interquartile range; TASC Trans-Atlantic Inter-Society Consensus II.
Continuous data are presented as the means ± standard deviation with the [median, IQR]; categorical data are given as the counts (percentage of their respective cohort).
There was no difference in technical success between POA and UEA (84.5% vs 88.8% p=0.230) (Table 2), which was also seen on multivariable analysis (OR, 0.99; 95% CI, 0.50 to 1.97; p=0.985) (Table 3). Univariate analysis also revealed technical failure was associated with TASC D lesions (p<0.001) and severe calcification (p<0.001) (Table 4). Dialysis was included as a forced variable in the multivariable analysis, which confirmed technical failure was associated with severe calcification (OR, 2.39; 95% CI, 1.18 to 4.89; p=0.016) and TASC D lesions (OR, 5.01; 95% CI 2.45 to 10.24; p<0.001).
Outcomes. a
Numbers in parentheses are percentages of their respective cohort.
A total of 47 popliteal patients did not have complications data and were thus excluded from the procedural outcomes and access site complications analysis for the popliteal cohort. The popliteal procedural outcomes and access site complications percentages are thus calculated with a denominator of 114 patients.
Statistically significant (p<0.05).
Multivariable Regression of Technical Failure.
Abbreviation: TASC, Trans-Atlantic Inter-Society Consensus II.
Factors Associated With Technical Success. a
Abbreviations: BMI, body mass index; TASC, Trans-Atlantic Inter-Society Consensus II.
Continuous data are presented as the means ± standard deviation with the [median, IQR]; categorical data are given as the counts (percentage of their respective cohort).
A higher proportion of the observed complications were seen in patients treated with UEA compared with patients treated with POA (10.1% vs 6.1%; p=0.041) (Tables 2 and 5). Specifically, with access site complications, there was a higher rate of complications with UEA compared with POA (4.3% vs 0.0%, p=0.027). Subgroup analysis of the UEA cohort revealed a higher frequency of complications among the brachial subgroup compared with the radial subgroup (10.5% vs 5.9%) (Table 6). Multivariate analysis confirmed overall complications were associated with UEA access (OR, 2.08; 95% CI, 0.80 to 5.37; p=0.016) (Table 7). While univariate analysis suggested the importance of additional factors (Table 8), multivariable analysis did not reveal a significant association of complications with gender (OR, 1.86; 95% CI, 0.78 to 4.42; p=0.132), prior smoking history (OR, 2.58; 95% CI, 0.92 to 7.18; p=0.705), or sheath sizes 7-Fr or greater (OR, 0.70; 95% CI, 0.14 to 3.34; p=0.9725).
Perioperative Complications. a
Categorical data are given as the counts (percentage).
A total of 47 popliteal patients did not have complications data and were thus excluded from the calculation of complications in the popliteal cohort.
Comparison of Perioperative Complications of Brachial and Radial Subgroups. a
Data are presented as counts (percentage).
Multivariable Regression of Factors Associated With Complications.
Factors Associated With Complications. a
Abbreviations: BMI body, mass index; CAD, coronary artery disease; CHF, congestive heart failure.
Continuous data are presented as the means ± standard deviation with the [median, IQR]; categorical data are given as the counts (percentage of their respective cohort).
Note that the 47 popliteal patients without any complications data were excluded from this analysis.
Discussion
Our study demonstrates that there is no difference in technical success between POA and UEA, and POA is associated with lower overall perioperative and access site complication rates. Especially considering that a higher proportion of patients in the POA cohort had TASC II D lesions, our study suggests the utility of retrograde POA access as an alternative approach in isolated SFA lesions.
The 88.8% UEA technical success rate observed in our study was consistent with rates reported for brachial (94%–99%) and radial access (84%–100%) in the literature.7,10,14,17,18 The 84.5% POA technical success rate was also similar to that of other studies, which reported a range between 80% and 100%.9,12,15,16,19 This large range in POA technical success can be partly attributed to the wide variability in technique, which has included prone and/or supine patient positioning and differing usage of duplex guidance.9,11,12,16,19 Although our study did not observe a statistically significant association between dialysis and technical success, dialysis was included as a forced variable in the multivariate regression model for technical failure due to its established association with inferior endovascular outcomes.20,21 The lack of association in our study may be partly attributable to the low number of patients on dialysis included in our study population (n=9) as well as our study’s focus on short-term, perioperative outcomes.
The association of technical failure with severe calcification and TASC II D lesions is consistent with current guidelines, which currently recommend surgical bypass over endovascular approaches for TASC II D lesions.1,20 Severe calcification has been recognized as a factor that increases technical difficulty and reduces the durability of endovascular intervention in the femoropopliteal region, which is reflected in the TASC II guidelines that relegate calcified lesions to more complex categories.1,22,23 Though with technical advances, greater operator familiarity, and new devices, there is growing use of the endovascular approach in these complex lesions.2,3,24 Interestingly, there was a greater proportion of TASC II D lesions treated via POA, which was also seen by Komshian et al. when comparing POA and CFA access. 15 The higher proportion of observed TASC II D lesions in the POA cohort compared with the UEA cohort suggests potential selection bias in which operators favor the use of POA over UEA in the setting of complicated, extensive SFA lesions. This trend may be partly attributable to the suggestion that the distal cap enables crossing of the lesions, which in turn may have enabled similar POA technical success rates despite the higher proportion of complex TASC II D lesions.9,11–13,15
Despite the use of POA for more complex lesions, we found that complications in our study were lower in the POA access cohort (6.1%) compared with the UEA access cohort (10.1%). The low complication rate seen in the POA access cohort, including an no access site complications, is within the reported 0% to 15.7% range found in the literature.9,12,16,19 In contrast, UEA access site complications occurred in 4.3% of our cohort, including 6 hematomas (3.2%) and 2 pseudoaneurysms (1.1%). These rates are in line with what has been previously reported in the recent literature, which cited complication rates from 1.3% to 10.6%. Subgroup analysis of the UEA cohort revealed a higher rate of complications among the brachial access subgroup (10.5%) compared with the radial access subgroup (5.9%), which is also consistent with the literature.6,7,9,10,17,25,26 While the radial access subgroup had a lower complication rate than the POA cohort, it is notable that only 17 patients of the 349 patients in our study were treated via radial access. Due to the small number in this subgroup, further statistical analysis was not appropriate. Similar to other studies, our univariate analysis also revealed that complications were also associated with female gender, prior smoking history, and larger sheath size; however, these associations were not confirmed on multivariable analysis.21,25,27
As a retrospective review of a prospectively maintained database, this study has several limitations. Due to potential errors in data entry, missing data, limited data entry fields, and heterogeneity of institutional procedures, there is an inherent selection bias in the data. Interestingly, the 47 patients without complication data were in the POA cohort. In addition, the use of POA in complex lesions, as described above, may have contributed to selection bias that skewed the characteristics of the POA and UEA cohorts; however, we utilized multivariable analysis to minimize this effect. A further limitation of the VQI is that in those cases where an attempt is made to cross a lesion which is unsuccessful, it is not recorded in the VQI, which may affect the validity of technical success in our cohort. Despite these restrictions, the VQI is the largest database to our knowledge that could provide adequate sample size to address alternative access site comparisons. In addition, the very small number of isolated SFA lesions approached from radial access site necessitated grouping of these patients into a single cohort with patients approached from brachial access sites to enable sufficient statistical power, thus limiting the specificity of our comparison to retrograde popliteal access. Furthermore, despite the growing use of pedal access as an alternative to CFA in recent years, the limited number of procedures during the time period examined precluded its inclusion in our study goals.
Conclusion
There is no difference in technical success between UEA and POA when treating isolated SFA occlusive disease, and UEA is associated with a higher access site complication rate. Technical success is dependent on calcification and TASC II classification. Based on similar technical success rates and low complication rates, POA should be considered as a viable alternative to UEA when planning endovascular interventions.
Footnotes
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
