Retrograde Transpopliteal Access Is Safe and EffectivedIt Should Be Added to the Vascular Surgeon’s Portfolio Houssam K. Younes, Hosam F. El-Sayed, and Mark G. Davies, Houston, Texas
Background: The aim of the study was to review the outcomes of superficial femoral artery (SFA) interventions using a retrograde transpopliteal access approach after failed antegrade recanalization. Methods: A database of patients undergoing endovascular treatment of the SFA between 2008 and 2011 was retrospectively queried, and those cases with transpopliteal artery retrograde access were analyzed. Time-dependent outcomes were determined by KaplaneMeier survival analyses. Results: A total of 16 patients (75% men; mean age 61 ± 9 years) underwent retrograde popliteal access after failed antegrade attempts. Patients had multiple cardiovascular comorbidities with a mean modified cardiac index score of 3.1 ± 1.8. The reason for intervention was lifestyle-limiting claudication in 67% of cases and critical ischemia in the remainder. Most of the lesions were Trans-Atlantic Inter-Society Consensus II C and D. Retrograde ultrasoundguided puncture of the popliteal artery was successful in all cases and there were no local site complications. Intervention was successful in 94% of cases. One uncomplicated perforation (7%) was encountered during attempted recanalization of the SFA in the thigh. There was no perioperative morbidity or 30-day mortality. The 30-day major adverse cardiovascular events rate was 6% but both 30-day major adverse limb events and the 30-day major amputation rate were 0%. There was a 40% increase in actual ankle-brachial index (ABI); 93% of patients achieved an ABI rise >0.15. On longer term follow-up, 2 patients developed restenosis and 1 an asymptomatic occlusion. Both restenosis patients required re-angioplasty. Two patients required expected toe amputations as a result of their presenting symptoms. The primary patency was 66 ± 9%, assisted patency 81 ± 9%, and secondary patency 87 ± 8% at 2 years. Limb salvage was 100%. Clinical efficacy was 63 ± 9% at 2 years. Conclusions: Ultrasound-guided retrograde transpopliteal access is a safe and successful technique, which extends the ability to perform endovascular interventions after failed antegrade approaches.
INTRODUCTION
Presented at the Winter Meeting of the Peripheral Vascular Surgery Society, Park City, UT, January 2013. Division of Vascular and Endovascular Surgery, Department of Cardiovascular Surgery, Houston Methodist Hospital, Houston, TX. Correspondence to: Mark G. Davies, MD, PhD, MBA, Department of Cardiovascular Surgery, Houston Methodist Hospital, 6550 Fannin Street, Smith Tower Suite 1401, Houston, TX 77030, USA; E-mail: [email protected] Ann Vasc Surg 2015; 29: 260–265 http://dx.doi.org/10.1016/j.avsg.2014.10.013 Ó 2015 Elsevier Inc. All rights reserved. Manuscript received: June 19, 2014; manuscript accepted: October 18, 2014; published online: November 24, 2014
260
Lower extremity interventions for claudication and critical limb ischemia are usually performed using contralateral retrograde or ipsilateral antegrade common femoral artery access. However, in up to 20% of cases there is a failure of recanalization and/or intervention from the conventional antegrade approach.1,2 Cases of retrograde transpopliteal approaches have been reported to facilitate endovascular intervention.3e5 We have previously reported an approximate 2% failure rate of recanalization during superficial femoral artery (SFA) interventions and adopted the transpopliteal approach to increase our ability to perform
Vol. 29, No. 2, February 2015
endovascular interventions.2 The aim of the study was to review the outcomes of SFA interventions using an ultrasound-guided retrograde transpopliteal access approach after failed antegrade recanalization.
METHODS Study Design A database of patients undergoing endovascular treatment of the SFA between 2008 and 2011 was retrospectively queried, and those cases with transpopliteal artery retrograde access were selected and analyzed. Data utilization fell under the category of secondary use of preexisting data as defined by the Health Insurance Portability and Accountability Act and the study was approved by the institutional review board. Study Setting Academic medical center with 900 beds in a catchment area of 5 million people. It is a tertiary and quaternary referral facility for vascular disease. Procedure Description All patients had already undergone a period of maximal medical therapy before moving on to intervention and all had antegrade approaches (contralateral retrograde or ipsilateral antegrade), which had failed or had a computed tomography angiogram showing an inability to perform the antegrade approach (e.g., aortobi-iliac graft). Thus, a lower extremity angiogram was always available for procedural planning. Popliteal vessels 5 mm or greater, which did not have significant calcification on the access wall were chosen for transpopliteal approach. We avoided using the transpopliteal approach in patients with 1 vessel runoff. With the patient placed in the prone position and under ultrasound guidance, access was gained to the popliteal at or above the knee using a 4-Fr micropuncture system. A 4-Fr sheath was then inserted and a retrograde angiogram performed. At this time, the patient received 40 units/kg of intravenous heparin. Thereafter, using a 0.035-in angled standard glide wire and catheter, retrograde recanalization was performed. Once the lesion was crossed successfully and an angiogram was performed to make sure the catheter was located within the true lumen, then balloon angioplasty was performed; stenting was only used if there was a failure of primary angioplasty. Completion angiograms were performed. No patients required
Retrograde popliteal access 261
conversion after initial recanalization to an antegrade therapeutic approach. After the intervention, the sheath and catheters were removed and hemostasis achieved with manual pressure. Protamine was administered if the activated clotting time was more than 250 sec. Methodology For each patient, demographics, symptoms, existing comorbid conditions, and risk factors for atherosclerosis were identified. Patients underwent routine duplex ultrasound follow-up at 1, 3, and every 6 months after their procedure using criteria previously described.2 During follow-up, angiography was only performed if noninvasive studies suggested restenosis and/or occlusion (positive duplex scan with a drop in ankle-brachial index (ABI) of >0.15 or a drop in toe-brachial index of >0.1) and/or the patient had recurrent symptoms. Median followup was 2.5 years (range, 0e11 years). Definitions The definitions of the demographic variables, procedural variables, and outcome variables have been described elsewhere.2 Patient-centered outcomes of clinical efficacy (CE; absence of recurrent symptoms, maintenance of ambulation, and absence of major amputation), amputation-free survival (AFS; survival without major amputation), and freedom from major adverse limb events (MALE; above-ankle amputation of the index limb or major reintervention [repeat endoluminal intervention, new bypass graft, and jump and/or interposition graft revision]).6 Statistical Analysis All statistical analyses were performed on an ‘‘intention-to-treat’’ basis. Measured values are reported as percentages or means ± standard deviation. Statistical differences in categorical data were tested by ManneWhitney tests or Fisher’s exact test. Timedependent variables were calculated and presented using KaplaneMeier analyses (mean ± standard error of the mean). Definitions of all outcome parameters have been described elsewhere.2 Analyses were performed using JMP software version 9.0 (SAS Institute, Cary, NC).
RESULTS Patient Population Sixteen patients (75% men; mean age, 61 ± 9 years) underwent retrograde popliteal access after failed
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Table I. Characteristics of patients Demographics Patients Limbs treated (n) Male (%) Average age (mean ± standard deviation, years) Presentation (%) Claudication Rest pain Tissue loss Comorbidities, (%) Modified Cardiac Risk Index (mean ± standard deviation) High risk Smoking history Current smoker Coronary artery disease Congestive heart failure Hypertension Diabetes Hyperlipidemia Statin Metabolic syndrome Chronic renal insufficiency Cerebrovascular disease Preoperative ambulatory status (%) Ambulatory Ambulatory/homebound
Table III. Procedures and complexity 16 16 75 61 ± 9
67 7 26 3.1 ± 1.8 56 87 33 56 23 93 67 67 73 56 0 19 40 60
SFA (%) Recanalization required Angioplasty Primary stenting Complexity score Complexity score
56 75 6 1.25 ± 0.45
metabolic syndrome but none had chronic renal insufficiency (estimated glomerular filtration rate 7)
7 53 40 2.1 ± 0.9 4.3 ± 3.1 3.6 ± 2.3 73 27 0
TASC, Trans-Atlantic Inter-Society Consensus II; SVS, Society for Vascular Surgery.
antegrade recanalization attempts (56%) and no safe antegrade access (44%) as a result of flush occlusion of the SFA or aortobi-femroal bypass graft. Patients had multiple cardiovascular comorbidities with a mean modified cardiac index score of 31 ± 1.9 and 56% were considered high risk (Table I). More than one-third of the patients continued to smoke and two-thirds were diabetics. Half of the patients had
Retrograde ultrasound-guided access of the popliteal artery was successful in all cases. Intervention was successful in 94% of cases. One uncomplicated perforation was encountered during attempted recanalization and this occurred in the mid thigh. Primary balloon angioplasty was the predominant modality used, and as a result, there was a low complexity score (Table III). Primary stenting was performed in 1 patient whereas 3 other patients had bailout stenting. No other adjunctive procedures were performed. There were no complications at the access site and there was no distal embolization. There was no perioperative morbidity or 30day mortality (Table IV). Overall morbidity was 12% because of 1 systemic (1 noneQ-wave myocardial infarction) and one lesional complication (1 perforation). The 30-day major adverse cardiovascular events rate was 6% but both the 30-day MALE and 30-day major amputation rates were 0% (Table IV). There was a 40% increase in actual ABI, with 93% of patients achieving a rise in ABI of >0.15 (Table V). Symptom resolution as reported by the patient was achieved in 32% of the cases, symptom improvement in 62%, and no change in 6% (Table V). Thus, 94% of patients reported improvement of symptoms. Most patients were
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Retrograde popliteal access 263
Table IV. Mortality, morbidity, and objective performance goals9 Actual (%)
Mortality and morbidity Mortality 0 Morbidity 6 Systemic 6 Lesional 6 Local 0 30-Day objective performance goals 30-Day MACE 6 30-Day MALE 0 30-Day major amputations 0 1-Year objective performance goals 1-Year MALE free 84 ± 9 1-Year MALE + POD free 80 ± 9 1-Year AFS 92 ± 7 1-Year limb salvage 100 ± 0 1-Year survival 78 ± 2
Goal (%)
8 8 3 55 62 71 71 80
MACE, major adverse cardiovascular event; POD, perioperative death.
Table V. Hemodynamic changes and immediate symptom relief Hemodynamic change Change in ABI (mean ± SD) ABI/TBI increase >0.15 (%) Symptom relief (%) Resolved Improved No change Deterioration Postoperative ambulatory status (%) Ambulatory Discharge status (%) Home Rehabilitation facility
0.37 ± 0.13 93 32 62 6 0
Fig. 1. Anatomic outcomes: KaplaneMeier analysis of primary, assisted primary, and secondary patencies are shown. Data are the mean ± standard error of the mean (SEM) and number of patients or limbs at risk shown in the table below the graph. No error bars are shown if the SEM is >10% and the data set terminates if the number at risk is 10% and the data set terminates if the number at risk is
Background: The aim of the study was to review the outcomes of superficial femoral artery (SFA) interventions using a retrograde transpopliteal access approach after failed antegrade recanalization. Methods: A database of patients undergoing endovascular treatment of the SFA between 2008 and 2011 was retrospectively queried, and those cases with transpopliteal artery retrograde access were analyzed. Time-dependent outcomes were determined by KaplaneMeier survival analyses. Results: A total of 16 patients (75% men; mean age 61 ± 9 years) underwent retrograde popliteal access after failed antegrade attempts. Patients had multiple cardiovascular comorbidities with a mean modified cardiac index score of 3.1 ± 1.8. The reason for intervention was lifestyle-limiting claudication in 67% of cases and critical ischemia in the remainder. Most of the lesions were Trans-Atlantic Inter-Society Consensus II C and D. Retrograde ultrasoundguided puncture of the popliteal artery was successful in all cases and there were no local site complications. Intervention was successful in 94% of cases. One uncomplicated perforation (7%) was encountered during attempted recanalization of the SFA in the thigh. There was no perioperative morbidity or 30-day mortality. The 30-day major adverse cardiovascular events rate was 6% but both 30-day major adverse limb events and the 30-day major amputation rate were 0%. There was a 40% increase in actual ankle-brachial index (ABI); 93% of patients achieved an ABI rise >0.15. On longer term follow-up, 2 patients developed restenosis and 1 an asymptomatic occlusion. Both restenosis patients required re-angioplasty. Two patients required expected toe amputations as a result of their presenting symptoms. The primary patency was 66 ± 9%, assisted patency 81 ± 9%, and secondary patency 87 ± 8% at 2 years. Limb salvage was 100%. Clinical efficacy was 63 ± 9% at 2 years. Conclusions: Ultrasound-guided retrograde transpopliteal access is a safe and successful technique, which extends the ability to perform endovascular interventions after failed antegrade approaches.
INTRODUCTION
Presented at the Winter Meeting of the Peripheral Vascular Surgery Society, Park City, UT, January 2013. Division of Vascular and Endovascular Surgery, Department of Cardiovascular Surgery, Houston Methodist Hospital, Houston, TX. Correspondence to: Mark G. Davies, MD, PhD, MBA, Department of Cardiovascular Surgery, Houston Methodist Hospital, 6550 Fannin Street, Smith Tower Suite 1401, Houston, TX 77030, USA; E-mail: [email protected] Ann Vasc Surg 2015; 29: 260–265 http://dx.doi.org/10.1016/j.avsg.2014.10.013 Ó 2015 Elsevier Inc. All rights reserved. Manuscript received: June 19, 2014; manuscript accepted: October 18, 2014; published online: November 24, 2014
260
Lower extremity interventions for claudication and critical limb ischemia are usually performed using contralateral retrograde or ipsilateral antegrade common femoral artery access. However, in up to 20% of cases there is a failure of recanalization and/or intervention from the conventional antegrade approach.1,2 Cases of retrograde transpopliteal approaches have been reported to facilitate endovascular intervention.3e5 We have previously reported an approximate 2% failure rate of recanalization during superficial femoral artery (SFA) interventions and adopted the transpopliteal approach to increase our ability to perform
Vol. 29, No. 2, February 2015
endovascular interventions.2 The aim of the study was to review the outcomes of SFA interventions using an ultrasound-guided retrograde transpopliteal access approach after failed antegrade recanalization.
METHODS Study Design A database of patients undergoing endovascular treatment of the SFA between 2008 and 2011 was retrospectively queried, and those cases with transpopliteal artery retrograde access were selected and analyzed. Data utilization fell under the category of secondary use of preexisting data as defined by the Health Insurance Portability and Accountability Act and the study was approved by the institutional review board. Study Setting Academic medical center with 900 beds in a catchment area of 5 million people. It is a tertiary and quaternary referral facility for vascular disease. Procedure Description All patients had already undergone a period of maximal medical therapy before moving on to intervention and all had antegrade approaches (contralateral retrograde or ipsilateral antegrade), which had failed or had a computed tomography angiogram showing an inability to perform the antegrade approach (e.g., aortobi-iliac graft). Thus, a lower extremity angiogram was always available for procedural planning. Popliteal vessels 5 mm or greater, which did not have significant calcification on the access wall were chosen for transpopliteal approach. We avoided using the transpopliteal approach in patients with 1 vessel runoff. With the patient placed in the prone position and under ultrasound guidance, access was gained to the popliteal at or above the knee using a 4-Fr micropuncture system. A 4-Fr sheath was then inserted and a retrograde angiogram performed. At this time, the patient received 40 units/kg of intravenous heparin. Thereafter, using a 0.035-in angled standard glide wire and catheter, retrograde recanalization was performed. Once the lesion was crossed successfully and an angiogram was performed to make sure the catheter was located within the true lumen, then balloon angioplasty was performed; stenting was only used if there was a failure of primary angioplasty. Completion angiograms were performed. No patients required
Retrograde popliteal access 261
conversion after initial recanalization to an antegrade therapeutic approach. After the intervention, the sheath and catheters were removed and hemostasis achieved with manual pressure. Protamine was administered if the activated clotting time was more than 250 sec. Methodology For each patient, demographics, symptoms, existing comorbid conditions, and risk factors for atherosclerosis were identified. Patients underwent routine duplex ultrasound follow-up at 1, 3, and every 6 months after their procedure using criteria previously described.2 During follow-up, angiography was only performed if noninvasive studies suggested restenosis and/or occlusion (positive duplex scan with a drop in ankle-brachial index (ABI) of >0.15 or a drop in toe-brachial index of >0.1) and/or the patient had recurrent symptoms. Median followup was 2.5 years (range, 0e11 years). Definitions The definitions of the demographic variables, procedural variables, and outcome variables have been described elsewhere.2 Patient-centered outcomes of clinical efficacy (CE; absence of recurrent symptoms, maintenance of ambulation, and absence of major amputation), amputation-free survival (AFS; survival without major amputation), and freedom from major adverse limb events (MALE; above-ankle amputation of the index limb or major reintervention [repeat endoluminal intervention, new bypass graft, and jump and/or interposition graft revision]).6 Statistical Analysis All statistical analyses were performed on an ‘‘intention-to-treat’’ basis. Measured values are reported as percentages or means ± standard deviation. Statistical differences in categorical data were tested by ManneWhitney tests or Fisher’s exact test. Timedependent variables were calculated and presented using KaplaneMeier analyses (mean ± standard error of the mean). Definitions of all outcome parameters have been described elsewhere.2 Analyses were performed using JMP software version 9.0 (SAS Institute, Cary, NC).
RESULTS Patient Population Sixteen patients (75% men; mean age, 61 ± 9 years) underwent retrograde popliteal access after failed
262 Younes et al.
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Table I. Characteristics of patients Demographics Patients Limbs treated (n) Male (%) Average age (mean ± standard deviation, years) Presentation (%) Claudication Rest pain Tissue loss Comorbidities, (%) Modified Cardiac Risk Index (mean ± standard deviation) High risk Smoking history Current smoker Coronary artery disease Congestive heart failure Hypertension Diabetes Hyperlipidemia Statin Metabolic syndrome Chronic renal insufficiency Cerebrovascular disease Preoperative ambulatory status (%) Ambulatory Ambulatory/homebound
Table III. Procedures and complexity 16 16 75 61 ± 9
67 7 26 3.1 ± 1.8 56 87 33 56 23 93 67 67 73 56 0 19 40 60
SFA (%) Recanalization required Angioplasty Primary stenting Complexity score Complexity score
56 75 6 1.25 ± 0.45
metabolic syndrome but none had chronic renal insufficiency (estimated glomerular filtration rate 7)
7 53 40 2.1 ± 0.9 4.3 ± 3.1 3.6 ± 2.3 73 27 0
TASC, Trans-Atlantic Inter-Society Consensus II; SVS, Society for Vascular Surgery.
antegrade recanalization attempts (56%) and no safe antegrade access (44%) as a result of flush occlusion of the SFA or aortobi-femroal bypass graft. Patients had multiple cardiovascular comorbidities with a mean modified cardiac index score of 31 ± 1.9 and 56% were considered high risk (Table I). More than one-third of the patients continued to smoke and two-thirds were diabetics. Half of the patients had
Retrograde ultrasound-guided access of the popliteal artery was successful in all cases. Intervention was successful in 94% of cases. One uncomplicated perforation was encountered during attempted recanalization and this occurred in the mid thigh. Primary balloon angioplasty was the predominant modality used, and as a result, there was a low complexity score (Table III). Primary stenting was performed in 1 patient whereas 3 other patients had bailout stenting. No other adjunctive procedures were performed. There were no complications at the access site and there was no distal embolization. There was no perioperative morbidity or 30day mortality (Table IV). Overall morbidity was 12% because of 1 systemic (1 noneQ-wave myocardial infarction) and one lesional complication (1 perforation). The 30-day major adverse cardiovascular events rate was 6% but both the 30-day MALE and 30-day major amputation rates were 0% (Table IV). There was a 40% increase in actual ABI, with 93% of patients achieving a rise in ABI of >0.15 (Table V). Symptom resolution as reported by the patient was achieved in 32% of the cases, symptom improvement in 62%, and no change in 6% (Table V). Thus, 94% of patients reported improvement of symptoms. Most patients were
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Retrograde popliteal access 263
Table IV. Mortality, morbidity, and objective performance goals9 Actual (%)
Mortality and morbidity Mortality 0 Morbidity 6 Systemic 6 Lesional 6 Local 0 30-Day objective performance goals 30-Day MACE 6 30-Day MALE 0 30-Day major amputations 0 1-Year objective performance goals 1-Year MALE free 84 ± 9 1-Year MALE + POD free 80 ± 9 1-Year AFS 92 ± 7 1-Year limb salvage 100 ± 0 1-Year survival 78 ± 2
Goal (%)
8 8 3 55 62 71 71 80
MACE, major adverse cardiovascular event; POD, perioperative death.
Table V. Hemodynamic changes and immediate symptom relief Hemodynamic change Change in ABI (mean ± SD) ABI/TBI increase >0.15 (%) Symptom relief (%) Resolved Improved No change Deterioration Postoperative ambulatory status (%) Ambulatory Discharge status (%) Home Rehabilitation facility
0.37 ± 0.13 93 32 62 6 0
Fig. 1. Anatomic outcomes: KaplaneMeier analysis of primary, assisted primary, and secondary patencies are shown. Data are the mean ± standard error of the mean (SEM) and number of patients or limbs at risk shown in the table below the graph. No error bars are shown if the SEM is >10% and the data set terminates if the number at risk is 10% and the data set terminates if the number at risk is
