Abstracts From the 2013 Amputation Prevention Symposium

AMP-1

Orbital Atherectomy Outcomes of the Claudicant Patient Population Within the CONFIRM Series

George Adams, MD, MHS, FACC, Jeffrey Indes, MD, Robert Beasley, MD, Robert Vorhies, MD, Nilesh M. Doshi, MD, J.A. Mustapha, MD, FACC, FSCAI

Introduction: Claudication as a result of peripheral artery disease (PAD) affects approximately 12% to 14% of the population in the United States and up to 20% of patients over the age of 75. In this population, which includes patients with advanced age, diabetes, and renal insufficiency, intra-arterial calcium is typically a predictor of poor endovascular treatment success. Methods of treating PAD have evolved and now include minimally invasive endovascular procedures that utilize orbital atherectomy (OA), which modifies calcific plaque both above and below the knee. Objective: We aim to evaluate the clinical outcomes of treating PAD in claudicant patients with orbital atherectomy. Materials and Methods: Three consecutive CONFIRM patient registries (the CONFIRM Series) were conducted prospectively under a naturalistic “real-world” procedure-focused registry (2009 to 2011). Inclusion criteria were medically necessary treatments in accordance with the device’s instructions for use. Thus, 3,135 patients suffering from PAD were enrolled on an “all-comers” basis. This resulted in registries that provide an analysis of the claudicant data as it pertains to the correlation of plaque morphology/calcification to the outcomes within the claudicant patient population after OA treatment. Discussion and Results: Claudicants represented 55% of the patients in the CONFIRM series (Rutherford Categories I-III). Procedural complications in the claudicant patient population (N=1,721) included dissection (flow limiting [FL], 1.6%; non-FL, 6.6%; unknown, 3.8%), perforation (0.6%), embolism (1.8%), and thrombus (1.1%). Eighty-one percent of the claudicant patient population (N=1,394) presented with severe to moderate calcium plaque burden. After treatment with orbital atherectomy, the occurrence of adverse events in this severe calcium-claudicant group was as follows: no event, 86.8%; dissection (FL, 1.4%; non-FL, 6.1%; unknown, 3.4%); and perforation, 0.6%. Conclusion: The majority of the claudicant patients in this study had lesions with moderate to severe calcification, yet the occurrences of adverse events were low after treatment with OA. Orbital atherectomy is a safe tool for restoring blood flow in the lower extremities of claudicant patients regardless of calcium burden.

AMP-2

Orbital Atherectomy Outcomes of the Critical Limb Ischemia Patient Population within the CONFIRM Series

Tony Das, MD, FACP, FACC, Jeffrey Indes, MD, Nilesh M. Doshi, MD, J.A. Mustapha, MD, FACC, FSCAI, George L. Adams, MD, MHS, FACC 

Introduction: Peripheral arterial disease (PAD) that results in critical limb ischemia (CLI) is associated with significant morbidity and mortality. Twenty-five to 30% of CLI patients will die and 30% will undergo amputation within the first year of diagnosis. In this population, which includes patients with advanced age, diabetes, and renal insufficiency, intra-arterial calcium is typically a predictor of poor endovascular treatment success. Methods of treating PAD have evolved and now include minimally invasive endovascular procedures that utilize orbital atherectomy (OA), which modifies calcific plaque both above and below the knee. Objective: We aim to evaluate the clinical outcomes of treating PAD in CLI patients with orbital atherectomy. Materials and Methods:  Three consecutive CONFIRM patient registries (the CONFIRM Series) were conducted prospectively under a naturalistic “real-world” procedure-focused registry (2009 to 2011). The only inclusion criteria were medically necessary treatments in accordance with the device’s instructions for use. Thus, 3,135 patients suffering from PAD were enrolled on an “all-comers” basis. This resulted in registries that provided an analysis of the CLI data as it pertains to the correlation of plaque morphology/calcification to the outcomes within the CLI patient population after OA treatment. Discussion and Results: In the CONFIRM series, 42.7% of patients had CLI (Rutherford Categories IV-VI). Procedural complications in the entire CLI patient population (N=1,340) included dissection (flow limiting [FL], 1.2%; non-FL, 4.6%; unknown, 3.8%), perforation (0.8%), embolism (2.1%), and thrombus (1.4%). Severe to moderate calcium plaque burden was presented in 87.5% of the CLI patient population (N=1,149). After treatment with orbital atherectomy the occurrence of adverse events in this severe calcium CLI group was no event (88.5%), dissection (FL, 1.1%; non-FL, 4.4%; unknown, 3.6%), and perforation (0.9%). Conclusion: The majority of the CLI patients in this study had lesions with moderate to severe calcification, yet the occurrences of adverse events were low after treatment with orbital atherectomy. Orbital atherectomy is a safe tool for restoring blood flow in the lower extremities of CLI patients regardless of calcium burden.

AMP-3

Pooled Analysis of the CONFIRM Registries: Outcomes in Patients with Renal Disease Treated for Peripheral Arterial Disease With Orbital Atherectomy

Michael S. Lee, MD 

Background: Patients with renal disease typically have severe calcification, which may lead to worse clinical outcomes after peripheral intervention compared to patients without renal disease. Patients with renal disease, who are hard to treat, historically have been excluded from clinical trials. Methods: Analysis of the CONFIRM I-III registries that included real-world patient population revealed 1,105 patients with renal disease (1,777 lesions) and 1,969 patients without renal disease (2,907 lesions) who underwent treatment with orbital atherectomy. The primary endpoint for this analysis was the composite of dissection (all types), perforation, slow flow, vessel closure, spasm and embolism, and the evidence of thrombus formation. Results: As expected, patients with renal disease had higher prevalence of diabetes, hypertension, hyperlipidemia, and coronary artery disease. Additionally, they had Rutherford categories between IV and VI and a higher number of infrapopliteal lesions and vessels treated. The primary endpoint rates for patients with and without renal disease were similar (21.3% vs 22.4%, P=.46). Specifically, results showed dissection (11.1% vs 11.5%, P=.83), perforation (0.6% vs 0.8%, P=.55), slow flow (5.0% vs 4.2%, P=.19), spasm (6.7% vs 6.2%, P=.40), embolism (1.7% vs 2.6%, P=.12), and evidence of thrombus (1.4% vs 1.0%, P=.56). The renal disease group had a trend toward decreased vessel closure (1.1% vs 1.6%, P=.08). Conclusion: In one of the largest registries, plaque modification with orbital atherectomy provided similar clinical outcomes in patients with renal disease compared to patients without renal disease despite having more unfavorable baseline clinical and lesion characteristics. 

AMP-4

Comparing Angiographic and Arterial Duplex Ultrasound Assessment of Tibial Arteries in Patients with Peripheral Vascular Disease

On Behalf of the Joint Endovascular and Non Invasive Assessment of Limb Perfusion (JENALI) Group

J.A. Mustapha, MD, Fadi Saab, MD, Larry Diaz-Sandoval, MD, Barbara Karenko, DO, Theresa McGoff, RN, Carmen Heaney, BSN, Matthew Sevensma, DO 

Background: Peripheral vascular disease (PVD) is an epidemic that impacts a large number of patients in the United States and western countries. Endovascular treatment of PVD involving the tibial arteries is becoming an increasingly important part of revascularization. The current anatomical description of vessel patency in tibial arteries does not contribute effectively to therapeutic strategies. The Joint Endovascular and Non Invasive Assessment of Limb Perfusion (JENALI) score is a novel scoring system developed to further assess patency of tibial arteries, via both angiography and arterial duplex ultrasonography (ultrasound). Scoring each lower extremity separately, each tibial vessel is divided into three segments: proximal, mid, and distal. If the segment is patent, a score of one is given. If the segment is occluded a score of zero is given. A total score of nine signifies that the three tibial arteries (anterior, posterior, and peroneal) in a limb are patent in all segments. The lower the score, the more segments occluded, correlating with increased disease burden. The same scoring system was applied to the tibial vessels imaged via arterial duplex ultrasound. A comparison was made between the JENALI score obtained by ultrasound and by angiography. Angiography is currently considered the gold standard of tibial artery imaging. Methods: This prospective, single-center study involved patients undergoing peripheral angiography for evaluation of PVD. After Institutional Review Board approval was obtained, 49 patients were enrolled in the trial between November 2011 and November 2012. As part of the study, all patients underwent a detailed ultrasound assessment of the tibial arteries ±7 days from angiography (prior to peripheral vascular intervention). Eligible patients had a Rutherford score III or abnormal Ankle Brachial Index values. Each angiogram was interpreted by four endovascular specialists each blinded to the ultrasound results. A noninvasive cardiovascular specialist, who was blinded to the angiographic assessments, interpreted the ultrasound images. Each reviewer was blinded to the other reviewers’ scores. Individual segments of the tibial arteries were scored for patency. Assuming angiography as the gold standard, sensitivity and specificity were calculated for patency and occlusion of individual segments. Results: Average age of patients was 69.8. Angiography and ultrasound assessed a total of 846 segments. Angiography deemed 648 segments (76.6%) to be patent compared to 723 (85.5%) by ultrasound. The difference (8.7%) is attributed to false positive readings by ultrasound. Critical limb ischemia (Rutherford IV) was described in 26 (53%) of patients. Average JENALI score for the right lower extremity by angiogram was 7.0 compared to 7.7 by ultrasound. The average JENALI score of the left leg was 6.7, compared to 7.7 by ultrasound. Figure 1 shows the distribution of the JENALI score via angiography. Ultrasound was accurate in detecting tibial artery patency or occlusion in 80% of segments. The overall sensitivity/specificity of ultrasound detecting tibial artery patency was calculated at 93% and 40% (P<.05), respectively. Detection of patency via ultrasound was highest for the anterior tibial artery and the lowest for the peroneal artery (Figure 2). Conclusion: Using the novel JENALI scoring system allowed for direct comparison between two imaging modalities. In theory the comparison can be extended to other imaging modalities. Ultrasound imaging had high sensitivity in detecting patent vessels confirmed by angiography. Detecting occluded segments via ultrasound was less accurate. The highest accuracy was in the more superficial arteries (anterior tibial and posterior tibial), compared to the deeper peroneal arteries. Risk stratification, treatment, and patient outcomes may be future applications for the JENALI scoring system.

AMP-5

Tibiopedal Arterial Minimally Invasive Retrograde Revascularization in Patients With Advanced Peripheral Vascular Disease: The TAMI Technique, a Novel Revascularization Technique

J.A. Mustapha, MD, Fadi Saab, MD, Theresa McGoff, BSN, Carmen Heaney, BSN 

Background: Peripheral vascular disease (PVD) is at epidemic levels. Critical limb ischemia (CLI) patients represent 1% to 2% of the PVD population. Many of these patients do not qualify for traditional access and intervention. We sought alternative access and interventional options for these advanced CLI patients. This is the first case series reporting on a novel technique to revascularize patients with advanced PVD. Using the tibiopedal arterial minimally invasive (TAMI) technique, the operators accessed and revascularized the lower extremity entirely via tibiopedal arterial access. Traditional common femoral artery access was not utilized in any of these cases. Methods: This is a case series of 23 patients admitted to our institution with advanced PVD. Nineteen patients (82.6%) had a Rutherford class IV-VI. Anemia was documented in 78% of patients. A creatinine level ≥1.5 was documented in 22% of our patients. Thirty-nine percent of patients had rest pain. An arterial ulcer was documented in 52% of patients. Patients were treated in a 3-month period in 2012. Ultrasound guidance was used to access 100% of the tibiopedal arteries. Results: Average age of patients in our series was 70. Arterial access was successful in 100% of patients. Thirty-six lesions were treated. Lesion success defined as post-treatment stenosis <30% was achieved in 95% of patients. Above-the-knee lesions were calculated at 25% (9 of 36). Average preprocedure stenosis was 94.2%. Average postprocedure stenosis was 11.5%. Baseline procedure variables with immediate outcomes are reported in Table 1. No immediate major complications were noted. Two patients presented within 30 days with complaints of access site pain. Both were discovered to have pseudoaneurysms and were treated percutaneously with a covered stent. Both patients recovered with no permanent sequelae. Conclusion: This is the first case series reporting on the novel TAMI technique. Retrograde tibiopedal intervention approach appears to be safe and effective. This novel technique offers alternative revascularization for critically ill CLI patients.

AMP-6

When Should Computed Tomography Angiography Be Used to Diagnose CLI? Factors Associated With a Poor Resolution Study

Gabriel Cristian Inaraja Pérez, MD, Maria Concepción Bernardos Alcalde, MD, Vicente Manuel Borrego Estella, PhD, Ana Cristina FernándezAguilar Pastor, MD, Miguel Ángel Marco Luque, MD, María Parra Rina, MD, Gerardo Pastor Mena, MD, Gonzalo Santana López, MD

Introduction: Critical limb ischemia (CLI) is a high resource-consuming disease with a very poor short-term vital prognosis. Although computed tomography (CT) angiography is a very useful tool for a morphologic diagnosis, one must keep in mind the need for contrast, the high radiation dose that the CT implies, and that the CT sometimes proves useless to indicate a certain procedure due to a heavy calcification. Objectives and Material/Methods: The aim of this study is to assess the risk factors associated to a nonuseful CT in order to reduce costs and the complications related to iodinated contrast. We collected data of 114 patients with CLI who were admitted from 2006 to 2010 at our hospital. On a per-patient analysis we compared factors associated to useless CTs to indicate a revascularization procedure. Results: Of the 114 patients included, 44 cases (38.6%) require an arteriography be done to indicate a procedure. There were 62 patients (54.4%) with diabetes, 83 patients (72.8%) with hypertension, 38 patients (33.3%) with dyslipidemia, and 78 (68.4%) patients were smokers. In the bivariate analysis, dyslipidemia (P=.030, RR=1.8) has been found to be an associated factor with useless CTs. This result has also been confirmed in the multivariate analysis (P=.043, OR=2.6). We have failed to show a relationship with diabetes or renal disease. Severe arterial calcification (nonvaluable CT) has been an independent prognostic factor of suffering complications during the hospital stay (P=.046, OR=2.4). Conclusion: We have identified that patients suffering from dyslipidemia have an increased risk of diagnosis with an angiography after having a CT. A nonvaluable CT, due to heavy arterial calcification, is associated with a high risk of complications during hospital stay.

AMP-7

Using the Clavien-Dindo Classification for Surgical Complications: Is It Applicable for Critical Limb Ischemia?

Gabriel Cristian Inaraja Pérez, MD, Maria Concepción Bernardos Alcalde, MD, Vicente Manuel Borrego Estella, PhD, Ana Cristina FernándezAguilar Pastor, MD, Miguel Ángel Marco Luque, MD, María Parra Rina, MD, Gerardo Pastor Mena, MD, Gonzalo Santana López, MD

Introduction: Critical limb ischemia (CLI) is a high resource-consuming disease with a very poor short-term vital prognosis. Complications usually occur when elderly, hospitalized patients suffer from severe comorbidities. Objectives and Materials/Methods: To assess the factors related to complications in patients (classification by Dindo et al, 2004), we collected data for 156 patients with CLI who were admitted to our hospital from 2006 to 2010. On a per-patient analysis, we compared factors associated to minor and major complications and their impact in the overall evolution of this disease. Results: Of the 156 patients included, 84 (53.8%) suffered no complications, 43 (27.6%) suffered minor complications, and 29 (18.6%) suffered major complications. The following associated factors have been found in the bivariate analysis: (1) hypertension (P=.021, RR=1.3), (2) coronary artery disease (P=.020, RR=2.2), (3) nephropathy (P=.037, RR=1.9), and (4) anesthetic risk American Society of Anesthesiologists (ASA) 4 (P=.002, RR=4.4). No significant difference has been shown between amputation vs revascularization related to minor or major complications. In the multivariate analysis, hypertension (P=0.033, OR=2.6) and anesthetic risk ASA 4 (P=0.006, OR=5.6) have been found to be independent predictors of complications during the admission. Needing opioids to relieve rest pain seems to be a risk factor for major complications (P=.012, OR=3.6). Discussion: The Clavien-Dindo classification for surgical complications is applicable to CLI patients, but it requires more research, taking survival and amputation-free survival into account. These patients could benefit from a multidisciplinary team to reduce complications associated with coronary artery disease and nephropathy.

AMP-8

Critical Limb Ischemia: Factors Leading to Primary Amputation

Gabriel Cristian Inaraja Pérez, MD, Maria Concepción Bernardos Alcalde, MD, Vicente Manuel Borrego Estella, PhD, Ana Cristina FernándezAguilar Pastor, MD, Miguel Ángel Marco Luque, MD, María Parra Rina, MD, Gerardo Pastor Mena, MD, Gonzalo Santana López, MD

Introduction: Primary major amputations are still necessary in certain cases when revascularization is not possible, especially when treating elderly patients who have severe comorbidities. Objectives and Materials/Methods: We collected data from 156 patients who were admitted to a tertiary hospital between 2006 and 2010 with a critical limb ischemia diagnose to analyze the risk factors associated with primary amputation. We also indexed the complications using the Clavien et al classification to check if there was any relation with patient-specific factors. Afterward, a per-patient SPSS statistical analysis was done. Results: Patients were treated with primary major amputation in 29 cases (19%) and revascularization in 127 cases (81%). Patients who were treated with revascularization procedures were younger (72.2 years) than patients with primary major amputation (77.2, P=.024). There were fewer women among those treated with revascularization procedures (25.2% vs 51.7%, P=.005) and they stayed longer in hospital (35 days vs 28 days, P=.007). On bivariate analysis, diabetes mellitus (P=.035, RR=1.4), heel trophic lesions (P=.003, RR=2.4), and gangrene (P<.001, RR=6.6) were significant predictors of primary amputation. Heavy calcification in computed tomography has shown also to be a risk factor for no revascularization options (P<.001, RR=2.4). Being self-sufficient has been proven to be a protective factor against primary amputation (P<.001, RR=0.4). Multivariate analysis showed that diabetes, female gender, and heavy artery calcification remained independent predictors of primary amputation. Discussion: Diabetes, female gender, and heavy artery calcification are all independent predictors of treatment with primary amputation as opposed to revascularization. Patients with major tissue loss are also at high risk of requiring amputation. We have not found differences in the complications between treatments with primary amputation or revascularization in the hospital setting.

AMP-9

The Best of Both Worlds: Combining Surgical Techniques With Atherectomy

George Pliagas, MD

Introduction: Patients are presenting more frequently with bilateral peripheral complex ischemic symptoms. I wanted to develop a unique hybrid strategy to treat both lesions concurrently. This strategy would allow evaluation and categorization of the bilateral symptomatology while combining traditional surgical fundamentals with orbital atherectomy. Objective: This study is intended to show that this unique hybrid approach is a practical and safe method to treat complex bilateral lower limb ischemic lesions and that both limbs respond to the initial hybrid revascularization and show excellent healing ability over time. Materials and Methods: From July 2010 to April 2013, 18 patients presented with bilateral ischemic lesions, which could not be treated with traditional percutaneous techniques. Evaluation of the lesions and the presenting vascular anatomy allowed categorization of these patients into one of three hybrid treatment modalities. Results: Analysis of the data showed successful initial revascularization as demonstrated by angiography of the concurrent lesions. A 30-day follow-up showed excellent healing, clinical improvement, and tolerance to the hybrid procedure. Conclusion: This unique system of categorization allows selection of the best hybrid approach to facilitate rapid revascularization of complex presenting anatomy. Discussion: This hybrid approach, which combines endovascular atherectomy with traditional vascular fundamentals, will appeal to vascular surgeons and interventionalists. This modality will help develop a team approach in certain communities to treat limb ischemia. In this era of medical economics, health experts will promote treatment of concurrent lesions during a patient’s hospitalization.

AMP-10

Incidence and Value of Diabetic Foot Salvage by Endovascular Intervention in an Organized Protocol

Mohamed Sharkawy, MD, Ahmed Farghaly, MD

Introduction: Diabetes affects almost 8% of Egyptians and up to 25% develop foot ulcers. Patients with diabetic foot ulcers and concomitant peripheral artery disease (PAD) (10% to 60%) are at a high risk for limb loss and premature death. Etiologic factors of diabetic foot lesion must be identified and managed. Options for revascularization and limb salvage have significantly increased with endovascular intervention. Objectives: This study aimed to identify the incidence of PAD in critical diabetic foot lesions, assess the impact of endovascular revascularization within organized protocol in limb salvage, and identify the missed factors that might lead to low limb salvage rates. Method: From January 2007 to December 2011, 318 patient referrals were accepted in a single center with diabetic foot ulcers who had been previously referred for amputation. The referrals were divided into the following two groups: (1) group A-patients referred for major limb amputation; and (2) group B-patients referred for minor amputations. Our protocol aimed to identify and correct all etiologic keys for the lesion, including blood quantity and quality of the affected foot. We administered endovascular revascularization when needed, along with local wound care, podiatric surgery, and orthotic management. All patients were followed up for a period of 12 months. Results: From the 318 patients referred for amputation, 112 were referred for major amputation (group A) (35.2%); and 206 were referred for minor amputations (group B) (64.8%). Incidence of concomitant PAD was 28.3% (71.4% in group A and 4.85% in group B). Other important missed etiologic keys were blood quality factor in 212 patients (66.7%), local bone lesion in 86 patients (27.04%), associated disease in 108 patients (33.96%), and improper local surgery and wound care in 53 patients (16.7%). Total incidence of limb salvage was achieved in 140 out of 318 patients (44.025%). In group A, there was 71.4% limb salvage (80 limbs out 112). In group B, there was 29.12% limb salvage (60 limbs out 206). We observed 55% limb salvage in patients with significant PAD and only 40% salvage in others. Discussion: Endovascular revascularization, as an integral part of a multidisciplinary protocol, is helpful in critical ischemic diabetic limb salvage. This changes the presence of PAD to a good prognostic factor in limb salvage. Efforts to detect and manage the preliminary lesions that are known to start pathogenesis of serious diabetic foot lesions are the best prophylactic measures in limb salvage. Training in podiatric surgery is of great value in limb salvage. Conclusion: Identification of all etiologic keys of every diabetic foot lesion is mandatory for planning a potentially successful limb salvage strategy. More studies and longer follow-up periods are needed for better evaluation, for updates to our protocol, and to evaluate the impact of all etiological keys, separate and when combined, in limb salvage.

AMP-11

Update to the Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions Study 

Craig Walker, MD, George L. Adams, MD, Robert Beasley, MD, Nelson Bernardo, MD, Yazan Khatib, MD, J.A. Mustapha, MD, Aravinda Nanjundappa, MD, Andrej Schmidt, MD, Thomas Zeller, MD

Introduction: A pandemic of peripheral artery disease has caused a global rise in the prevalence of critical limb ischemia (CLI). Although bypass is effective, patients with CLI often lack suitable inflow, autologous vein, and/or adequate outflow and are, therefore, poor surgical candidates. A vital need exists for interventional strategies to successfully cross occlusions. Retrograde tibiopedal access can make revascularization possible when a previous antegrade attempt has failed. This is of critical importance for patients who do not have viable alternatives for limb salvage. Other advantages of tibiopedal access are reduced bleeding risk, re-entry tool use, and reduced cost. Some interventionalists use primary tibiopedal access for the treatment of claudication and CLI. Concerns with tibiopedal access include vascular trauma and the destruction of future distal bypass sites. A prospective, multicenter study on the use of tibiopedal access to facilitate retrograde crossing of infrainguinal occlusions will begin to elucidate the technique’s safety and efficacy. Methods: A total of 200 patients will be enrolled from 12 sites. Eligible patients have a total occlusion of an infrainguinal artery. Techniques used for access, lesion crossing, and treatments are at the operator’s discretion. Follow-up data are obtained 30 days after the procedure. Results: Currently, 9 institutions have enrolled 181 patients. The study population was divided based on Rutherford score: (1) claudicants (Rutherford score ≤III; 33.7% of patients), (2) patients with CLI (Rutherford score ≥IV; 66.3%). No significant difference in patient age is observed between groups (69 ±11 years in claudicants vs 72 ±11 years in patients with CLI). Operators attempted an antegrade approach to cross lesions prior to a retrograde tibiopedal attempt in similar proportions (62.3% of claudicants and 65.8% of those with CLI). Conclusion: The results suggest that tibiopedal access is used to cross lesions of varying severity in a range of lower-limb arteries. The technique is relatively new and limited clinical data is available. This study is a vital step toward establishing the eligible patient population, complications, and success rates of tibiopedal access and retrograde crossing associated with this technique.

AMP-12

TAMI Retrograde Without Antegrade Access

John Hovorka, MD

Introduction: Patients who are unable to be accessed by the common femoral artery (crossover or antegrade access) are often considered nonrevascularizable. Radial or brachial access is an option, although the length makes maneuverability and intervention in tibial vessels difficult. Objective: Demonstrate use of tibiopedal arterial minimally invasive (TAMI) retrograde without antegrade access as safe and successful in critical limb ischemia. Methods: Five patients, at least 65 years old, were unable to have common femoral or femoral access. All patients had TAMI retrograde and work was done through distal retrograde access. Patient 1 (Rutherford VI) had failed femoral stents (bayonetted) and failed femoropopliteal below-the-knee graft. He did not have diabetes and he was a smoker. He was not considered revascularizable due to a lack of suitable outflow vessel. He underwent an atherectomy of the posterior tibial artery, as directed by intravascular ultrasound (IVUS) using the TAMI technique. One month later he underwent a successful CryoVein bypass. Patients 2, 3, and 4 all had critical limb ischemia by transcutaneous oxygen measurement (TCOM), with TCOM less than 30, rest pain, and ulceration (Rutherford V). Antegrade access was not available due to obesity and the inability to lie down. After intervention and revascularization with laser, as well as IVUS and angiogram performed through the TAMI access, TCOM was >50 in all patients. Rest pain resolved and ulcers healed. Patient 5 had Rutherford score VI and received anterior tibial artery revascularization and is pending CryoVein bypass. Patients 2 through 5 required high-frequency ultrasound probes to identify access artery. After access, in order to introduce sheath fully, all required debulking with a 0.9-mm fiber laser, and then upsized to 4 Fr sheath to allow IVUS to further guide debulking. Patients 2, 3, and 4 all had debulking femoralpopliteal and tibial territories through TAMI and IVUS, as well as angiogram showed in line flow to access site. Discussion: TCOM provides objective reproducible evidence of improvement. Matched pairs analyses are pending. All vessels are currently patent with follow-up of 3 months for patients 2, 3, and 4. Conclusion: In this series TAMI as a sole access appears to be safe and effective when no proximal access is possible.

AMP-13

Pooled Analysis of the CONFIRM Registries: Impact of Gender on Outcomes in Patients Treated for Arterial Disease With Orbital Atherectomy

Michael S. Lee, MD

Background: Previous studies have shown worse outcomes in females who undergo peripheral intervention when compared with males. Data are limited in terms of gender differences and clinical outcomes after peripheral intervention with orbital atherectomy. Methods: Analysis of the CONFIRM I-III registries revealed 1,261 female patients (1,847 lesions) and 1,870 male patients (2,887 lesions) who underwent orbital atherectomy for treatment of peripheral arterial disease. The primary endpoint for this analysis was the composite of dissection (all types, A-F), perforation, slow flow, vessel closure, spasm, embolism, and thrombus formation. Results: Both females and males had a successfully low final residual stenosis (9% ± 11% vs 11% ± 11%, P<.001). Females were older (73.2 ± 10.7 vs 70.4 ± 10.2, P<.001) and had higher prevalence of critical limb ischemia (Rutherford Categories IV-VI: 44.8% vs 41.4%, P=.006). Females also had a higher rate of the primary endpoint (24.1% vs 20.5%, P=.004), mainly driven by a higher rate of dissections of any type (13.3% vs  9.9%, P<.001). Females and males had similar rates of perforation (0.8% vs  0.7%, P=.57), slow flow( 4.4% vs 4.5%, P=.96), vessel closure (1.8% vs 1.2%, P=.11), and thrombus formation (1.3% vs 1.2%, P=.74).Females had a trend toward increased embolism (2.8% vs 1.9%, P=.07). Conclusion: The gender analysis of the CONFIRM registries revealed that there was successful lesion modification with orbital atherectomy in both female and male patients; however, females had a higher rate of dissections (all types). This difference is likely due to the older age and higher percentage of critical limb ischemia in females vs males in this study. These results, however, suggest that additional studies should be completed to further understand the increased risks for females vs males during endovascular procedures.