A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery.

OBJECTIVE: The aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population. METHODS: We conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization at 12 months. Secondary endpoints included technical success, target vessel revascularization, major limb amputation, and all-cause mortality. Results are presented as survival probabilities based on Kaplan-Meier survival estimates. RESULTS: Patients (N = 300) were 58% male, with a mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication, and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Lesions were categorized as occlusions in 43% (mean occluded length, 16 ± 10 cm). TASC type was A (17%), B (29%), C (38%), and D (15%). Technical success was 99%. Re-stenting was performed in 5% and thrombolysis in 0.6% of patients. Kaplan-Meier estimates for freedom from target lesion revascularization were 90%, 72%, and 62% at 12, 24, and 36 months. Freedom from target vessel revascularization was 88%, 68%, and 59% and freedom from major target limb amputation was 99.6%, 98.9%, and 98.9%, respectively, at 12, 24, and 36 months. Survival was 95%, 89%, and 85% at 12, 24, and 36 months. CONCLUSIONS: This post-market registry-based study shows promising results in treating femoral-popliteal ISR with paclitaxel DCB in comparison to the results of plain balloon angioplasty reported in the literature. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.

A Novel Quality of Life Instrument for Patients with an Abdominal Aortic Aneurysm.

OBJECTIVE: The surveillance and treatment of abdominal aortic aneurysms (AAAs) may impact patient quality of life (QOL). A novel AAA specific QOL instrument was developed and validated to quantify the impact of AAA surveillance on QOL. METHODS: The study was performed in two phases: development (2011-2013) and validation (2013-2014) of a survey instrument. Content was informed by focus groups at three centres (22 patients) and two multidisciplinary physician focus groups (6 vascular surgeons, 7 primary care providers). Cognitive interviews (17 patients) ensured questions were understood as intended. The final survey was mailed to AAA patients at six US institutions. Patients were scored on two AAA specific domains of QOL: emotional impact (EIS) and behavioural change (BCS), range 0-100 with higher scores indicating worse quality of life. Test retest reliability and internal consistency were assessed. Discriminant validity was determined by comparing scores between patients under surveillance vs. those who had undergone AAA repair. Scores were externally validated by correlation with the Short Form (SF)-12. RESULTS: A total of 1,008 (73%) of 1,373 patients returned surveys: 351 (35%) were under surveillance, 657 (65%) had undergone repair (endovascular, 414; open, 179; unsure, 64). Median EIS was 11 (range 0-95; IQR 7-26). Median BCS was 13 (range 0-100; IQR 9-47). To test reliability, 337 patients repeated the survey after four weeks with no significant differences between scores over time. EIS and BCS demonstrated good internal consistency (Cronbach's Alpha 0.85 and 0.75 respectively). There was strong correlation between scores (r = 0.53) and both related moderately to SF-12 scores (r = 0.45 and r = 0.39, respectively). Patients under AAA surveillance had worse EIS than repair patients (22 vs. 13; p < .001). Patients with a higher perceived rupture risk had a worse EIS (45 vs. 12; p < .001) and BCS (30 vs. 13; p < .001). CONCLUSIONS: An AAA specific QOL instrument was successfully created and validated. The range of impact on QOL by AAA surveillance is broad. For most patients the impact is minimal, but for some, especially those with a greater perceived rupture risk, it is severe.

Midterm outcomes of catheter-directed interventions for the treatment of acute pulmonary embolism.

Objective The hemodynamic benefits of catheter-directed thrombolysis for acute pulmonary embolism have not been clearly defined beyond the periprocedural period. The objective of this study is to report midterm outcomes of catheter-directed thrombolysis for treatment of acute pulmonary embolism. Methods Records of all patients undergoing catheter-directed thrombolysis for high- or intermediate-risk pulmonary embolism were retrospectively reviewed. Endpoints were clinical success, procedure-related complications, mortality, and longitudinal echocardiographic parameter improvement. Results A total of 69 patients underwent catheter-directed thrombolysis (mean age 59 ± 15 y, 56% male). Eleven had high-risk and 58 intermediate-risk pulmonary embolism. Baseline characteristics did not differ by pulmonary embolism subtype. Fifty-two percent of patients underwent ultrasound-assisted thrombolysis, 39% standard catheter-directed thrombolysis, and 9% other interventional therapy; 89.9% had bilateral treatment. Average treatment time was 17.7 ± 11.3 h with average t-Pa dose of 28.5 ± 19.6 mg. The rate of clinical success was 88%. There were two major (3%) and six minor (9%) periprocedural bleeding complications with no strokes. All echocardiographic parameters demonstrated significant improvement at one-year follow-up. Pulmonary embolism-related in-hospital mortality was 3.3%, and estimated survival was 81.2% at one year. Conclusions Catheter-directed thrombolysis is safe and effective for treatment of acute pulmonary embolism, with sustained hemodynamic improvement at one year. Further prospective large-scale studies are needed to determine comparative effectiveness of interventions for acute pulmonary embolism.

A national survey of disease-specific knowledge in patients with an abdominal aortic aneurysm.

OBJECTIVE: Patient education is a fundamental responsibility of medical providers caring for patients with abdominal aortic aneurysms (AAA). We sought to evaluate and quantify AAA-specific knowledge in patients under AAA surveillance and in patients who have undergone AAA repair. METHODS: In 2013, 1373 patients from 6 U.S. institutions were mailed an AAA-specific quality of life and knowledge survey. Of these patients, 1008 (73%) returned completed surveys for analysis. The knowledge domain of the survey consisted of nine questions. An AAA knowledge score was calculated for each patient based on the proportion of questions answered correctly. The score was then compared according to sex, race, and education level. Surveillance and repaired patients were also compared. RESULTS: Among 1008 survey respondents, 351 were under AAA surveillance and 657 had AAA repair (endovascular repair, 414; open, 179; unknown, 64). The majority of patients (85%) reported that their "doctor's office" was their most important source of AAA information. The "Internet" and "other written materials" were each reported as the most important source of information 5% of the time with "other patients" reported 2% of the time. The mean AAA knowledge score was 47% (range 0%-100%; standard deviation, 23%) with a broad variation in percentage correct between questions. Thirty-two percent of respondents did not know that larger AAA size increases rupture risk, and 64% did not know that AAA runs in families. Only 15% of patients answered six or more of the nine questions correctly, and 23% of patients answered two or fewer questions correctly. AAA knowledge was significantly greater in men compared with women, whites compared with nonwhites, high school graduates compared with nongraduates, and surveillance compared with repaired patients. CONCLUSIONS: In a national survey of AAA-specific knowledge, patients demonstrated poor understanding of their condition. This may contribute to anxiety and uninformed decision making. The need for increased focus on education by vascular providers is a substantial unmet need.

Contemporary outcomes of open and endovascular popliteal artery aneurysm repair.

OBJECTIVE: The purpose of this study was to evaluate contemporary practice and outcomes of open repair (OR) or endovascular repair (ER) for popliteal artery aneurysms (PAAs). METHODS: Consecutive patients with PAA treated at one institution from January 2006 to March 2014 were reviewed under an Institutional Review Board-approved protocol. Demographics, indications, anatomic characteristics, and outcomes were collected. Standard statistical methods were used. RESULTS: A total of 186 PAAs were repaired in 156 patients (110 ORs, 76 ERs) with a mean age of 71 ± 11 years, and most were male (96%). Mean follow-up was 34.9 ± 28.6 months for OR and 28.3 ± 25.8 months for ER (P = .12). Comorbidities were similar between groups. OR was used in more patients with PAA thrombosis (41.8% vs 5.3%; P < .001), acute ischemia (24.5% vs 9.2%; P = .010), and ischemic rest pain (34.5% vs 6.6%; P < .001). Mean tibial (Society for Vascular Surgery) runoff score was 5.0 for OR vs 3.3 for ER (P = .006). OR was associated with increased 30-day complications (22% vs 2.6%; P < .001) and mean postoperative stay (5.8 vs 1.6 days; P < .001). There was no difference in 30-day mortality (OR, 1.8%; ER, 0%; P = .56) or major amputation rate (OR, 3.7%; ER, 1.3%; P = .65). Primary, primary assisted, and secondary patency rates were similar at 3 years (OR, 79.5%, 83.7%, and 85%; ER, 73.2%, 76.3%, and 83%; P = NS). Among 130 patients presenting electively without acute ischemia or thrombosed PAA (63 ORs and 67 ERs), OR had better 3-year primary patency (88.3% vs 69.8%; P = .030) and primary assisted patency (90.2% vs 73.5%; P = .051) but similar secondary patency (90.2% vs 82%; P = .260). ER thrombosis was noted in 8 of 24 patients treated in 2006-2008 (33%; mean time to failure, 49 months) but in only 4 of 51 patients treated in 2009-2013 (7.8%; mean time to failure, 30 months), suggesting a steep learning curve. CONCLUSIONS: ER is a safe and durable option for PAA, with lower complication rates and a shorter length of stay. OR has superior primary patency in patients treated electively but no difference in midterm secondary patency and amputations.

Risk Factors for Long-Term Mortality and Amputation after Open and Endovascular Treatment of Acute Limb Ischemia.

BACKGROUND: Acute limb ischemia (ALI) is a highly morbid and fatal vascular emergency with little known about contemporary, long-term patient outcomes. The goal was to determine predictors of long-term mortality and amputation after open and endovascular treatment of ALI. METHODS: A retrospective review of ALI patients at a single institution from 2005 to 2011 was performed to determine the impact of revascularization technique on 5-year mortality and amputation. For each main outcome 2 multivariable models were developed; the first adjusted for preoperative clinical presentation and procedure type, the second also adjusted for postoperative adverse events (AEs). RESULTS: A total of 445 limbs in 411 patients were treated for ALI. Interventions included surgical thrombectomy (48%), emergent bypass (18%), and endovascular revascularization (34%). Mean age was 68 ± 15 years, 54% were male, and 23% had cancer. Most patients presented with Rutherford classification IIa (54%) or IIb (39%). The etiology of ALI included embolism (27%), in situ thrombosis (28%), thrombosed bypass grafts (32%), and thrombosed stents (13%). Patients treated with open procedures had significantly more advanced ischemia and higher rates of postoperative respiratory failure, whereas patients undergoing endovascular interventions had higher rates of technical failure. Rates of postprocedural bleeding and cardiac events were similar between both treatments. Excluding Rutherford class III patients (n = 12), overall 5-year mortality was 54% (stratified by treatment, 65% for thrombectomy, 63% for bypass, and 36% for endovascular, P < 0.001); 5-year amputation was 28% (stratified by treatment, 18% for thrombectomy, 27% for bypass, and 17% for endovascular, P = 0.042). Adjusting for comorbidities, patient presentation, AEs, and treatment method, the risk of mortality increased with age (hazard ratio [HR] = 1.04, P < 0.001), female gender (HR = 1.50, P = 0.031), cancer (HR = 2.19, P < 0.001), fasciotomy (HR = 1.69, P = 0.204) in situ thrombosis or embolic etiology (HR = 1.73, P = 0.007), cardiac AEs (HR = 2.25, P < 0.001), respiratory failure (HR = 2.72, P < 0.001), renal failure (HR = 4.70, P < 0.001), and hemorrhagic events (HR = 2.25, P = 0.003). Risk of amputation increased with advanced ischemia (Rutherford IIb compared with IIa, HR = 2.57, P < 0.001), thrombosed bypass etiology (HR = 3.53, P = 0.002), open revascularization (OR; HR = 1.95, P = 0.022), and technical failure of primary intervention (HR = 6.01, P < 0.001). CONCLUSIONS: After the treatment of ALI, long-term mortality and amputation rates were greater in patients treated with open techniques; OR patients presented with a higher number of comorbidities and advanced ischemia, while also experiencing a higher rate of major postoperative complications. Overall, mortality rates remained high and were most strongly associated with baseline comorbidities, acuity of presentation, and perioperative AEs, particularly respiratory failure. Comparatively, amputation risk was most highly associated with advanced ischemia, thrombosed bypass, and failure of the initial revascularization procedure.

Revascularization of asymptomatic carotid stenosis is not appropriate in patients on dialysis.

OBJECTIVE: Outcomes of carotid endarterectomy (CEA) or carotid angioplasty and stenting (CAS) for asymptomatic disease in patients on dialysis are not well characterized, with questionable stroke prevention and survival. This study reports outcomes of carotid revascularization in asymptomatic dialysis patients in the United States. METHODS: Using United States Renal Data System (USRDS) databases, we identified all dialysis patients who underwent CEA or CAS for asymptomatic disease from 2005 to 2008. CEA and CAS were identified by Current Procedural Terminology (American Medical Association, Chicago, Ill) codes, and symptom status and comorbidities by International Classification of Diseases-9th Revision, Clinical Modification codes. Primary outcomes were stroke, cardiac complications, and death at 30 days and at 1 and 3 years. Predictors of death were identified using multivariate regression models. RESULTS: Of 738,561 dialysis patients, 2131 asymptomatic patients underwent carotid revascularization (1805 CEA, 326 CAS). The mortality rate was 4.7% at 30 days (4.6% CEA, 4.9% CAS; P = .807). Kaplan-Meier estimates of survival were 75.1% at 1 year (75.9% CEA, 70.7% CAS) and 43.4% at 3 years (43.7% CEA, 41.6% CAS). The stroke rate was 6.5% at 30 days (6.4% CEA, 6.9% CAS; P = .774) and 13.6% at 1 year (13.3% CEA, 15.0% CAS; P = .490). Cardiac complications occurred in 22.0% of patients (3.3% myocardial infarction) at 30 days (22.2% CEA, 20.6% CAS; P = .525). The combined stroke or death rate was 10.2% at 30 days (10.1% CEA, 10.9% CAS; P = .490) and 33.5% at 1 year (32.2% CEA, 39.6% CAS; P = .025). Age >70 years at the time of surgery and increased time on dialysis were predictive of death, whereas a history of renal transplant was a protective factor. CONCLUSIONS: Patients on dialysis have high perioperative and long-term stroke or death rates after CEA or CAS for asymptomatic stenosis, with a median survival that is less than recommended by current guidelines. As a result, carotid intervention in these patients appears to be inappropriate.

Comparative effectiveness of endovascular versus surgical revascularization for acute lower extremity ischemia.

OBJECTIVE: Thrombolysis and open surgical revascularization are current options for the treatment of acute limb ischemia (ALI). Despite the several randomized controlled trials comparing the two options, no single treatment can yet be recommended as a universal initial management of ALI. The purpose of this study was to evaluate contemporary endovascular and surgical revascularization for ALI. METHODS: Consecutive patients with ALI treated with endovascular revascularization (ER) or open revascularization (OR) between 2005 and 2011 were identified and reviewed. Procedural success and outcomes were compared between the two groups. Limb salvage and survival were assessed by time-to-event methods, including Kaplan-Meier estimation and competing-risks regression models. RESULTS: A total of 154 limbs were treated in 147 patients in the ER group, compared with 326 limbs in 296 patients in the OR group. The mean follow-up was 14 ± 18.5 months. The majority of patients presented with Rutherford II ischemia (83% for OR, 90% for ER). In Rutherford II patients, technical success was achieved in 90.7% of the OR group vs 79.9% of the ER group (P = .002), with amputation rates of 10.0% vs 7.2% (P = .35) at 30 days and 16.3% vs 13.0% (P = .37) at 1 year, respectively. In Rutherford II patients with failed bypass graft, technical success rate was 95.0% (OR) vs 75.0% (ER) (P = .001), whereas the amputation rate was 6.3% vs 15.38% (P = .13) at 30 days and 24.1% vs 23.1% (P = .90) at 1 year, respectively. The overall 30-day mortality rate was 13.2% (OR) and 5.4% (ER) (P = .012). Overall amputation rates were 13.5% (OR) vs 6.5% (ER) at 30 days (P = .023) and 19.6% (OR) vs 13.0% (ER) at 1 year (P = .074). The primary patency rate was 57% (OR) and 51% (ER) at 1 year (P = .74). Predictors of limb loss by life-table analysis included coronary artery disease (hazard ratio [HR], 2.0; P = .007) and Rutherford category III (HR, 19.0; P < .001). Predictors of death by life-table analysis included age (HR, 1.03; P < .001), end-stage renal disease (HR, 7.28; P < .001), cancer (HR, 1.65; P = .005), and chronic obstructive pulmonary disease (HR, 1.61; P = .005). CONCLUSIONS: In patients presenting with class II ALI, ER or surgical OR resulted in comparable limb salvage rates. Although technical success is higher with OR for patients presenting with failed bypass grafts, the amputation rates are comparable. Overall mortality rates are significantly higher at 30 days and 1 year in the OR group.

Limited survival in dialysis patients undergoing intact abdominal aortic aneurysm repair.

OBJECTIVE: Elective abdominal aortic aneurysm (AAA) repair in suitable candidates is a standard modality. The outcomes of AAA repair in patients with end-stage renal disease on dialysis are not well characterized, and there is questionable survival advantage in such patients with limited life expectancy. We sought to describe outcomes after AAA repair in U.S. dialysis patients. METHODS: The United States Renal Data System was used to collect data on intact asymptomatic AAA repair procedures in dialysis patients in the United States between 2005 and 2008. Endovascular AAA repair (EVAR) and open aortic repair (OAR) were identified by Current Procedural Terminology codes. Primary outcomes were perioperative (30-day) mortality and long-term survival. Predictors of mortality were identified by multivariate regression models. RESULTS: A total of 1557 patients were identified who had undergone elective AAA repair: 261 OAR and 1296 EVAR. The 30-day mortality was 11.3% (EVAR, 10.3%; OAR, 16.1%; P = .010), with increased age associated with increased mortality (odds ratio, 1.04; 95% confidence interval [CI], 1.02-1.07; P = .001). Kaplan-Meier survival estimates were 66.5% at 1 year (EVAR, 66.2%; OAR, 68%) and 37.4% at 3 years (EVAR, 36.8%; OAR, 40%; P = .33). Median survival was 25.3 months after EVAR and 27.4 months after OAR. Women had a higher mortality rate at 1 year (38.7%) compared with men (32.0%) (P = .015). There was no significant mortality difference at 1 year in comparing type of procedure in both men (EVAR, 31.6%; OAR, 34%; P = .55) and women (EVAR, 39.3%; OAR, 36%; P = .60). A Cox proportional hazards model demonstrated that male gender (hazard ratio [HR], 0.75; 95% CI, 0.62-0.92; P = .005), increased time on dialysis (HR for each year on dialysis, 0.79; 95% CI, 0.75-0.83; P < .001), kidney transplantation history (HR, 0.62; 95% CI, 0.43-0.88; P = .008), and diagnosis of hypertension (HR, 0.60; 95% CI, 0.48-0.75; P < .001) were protective against mortality. Increased age (HR, 1.02; 95% CI, 1.01-1.03; P < .001) and diabetes diagnosis (HR, 1.39; 95% CI, 1.13-1.71; P = .002) predicted increased mortality. CONCLUSIONS: AAA patients on dialysis have high perioperative and 1-year mortality rates after EVAR or OAR, particularly diabetics, women, and the elderly. This raises questions about the indications for intact AAA repair in dialysis patients, in whom the size threshold may need to be raised. Dialysis patients may be best served by deferring repair of AAA until AAAs reach large size or become symptomatic, especially if OAR is required, given the higher perioperative mortality compared with EVAR.

Contemporary outcomes of endovascular interventions for acute limb ischemia.

OBJECTIVE: Thrombolysis as a treatment for acute limb ischemia (ALI) has become a first-line therapy based on studies published over 2 decades ago. The purpose of this study was to assess outcomes of patients treated for ALI using contemporary thrombolytic agents and endovascular techniques. METHODS: Consecutive patients with ALI of the lower extremities treated between 2005 and 2011 were identified, and their records were retrospectively reviewed. All patients were treated with tissue plasminogen activator delivered via catheter-directed thrombolysis (CDT) and/or pharmacomechanical thrombolysis (PMT), with other adjunctive endovascular or surgical interventions. Procedural success, thrombolysis duration, and 30-day and long-term outcomes were obtained for the whole series and were also compared between the CDT and PMT groups. Limb salvage and survival were assessed using time-to-event methods, including Kaplan-Meier estimation and Cox proportional hazards models. RESULTS: A total of 154 limbs were treated in 147 patients presenting with ALI (Rutherford class I, 9.7%; class IIa, 70.1%; class IIb, 20.1%). The mean follow-up was 15.20 months (range, 0.56-56.84 months). Indications for intervention included embolization (14.3%), thrombosed bypass (36.4%), thrombosed stent (26.6%), native artery thrombosis (24.0%), and thrombosed popliteal aneurysm (3.2%). Technical success was achieved in 83.8% of cases, with a 30-day mortality rate of 5.2%. Procedural complications included systemic bleeding (5.2%), access site hematoma (4.5%), acute renal failure (1.9%), and distal embolization (9.7%). The mean runoff score decreased from 13.42 preintervention to 7.43 postintervention. Adjuvant revascularization procedures were required in 89.0% of patients and were endovascular (68.8%), hybrid (9.1%), or open (11.0%). Only 3.2% of patients required a fasciotomy. The overall rate of major amputation was 15.0% (18.1% for CDT only, 11.3% for PMT; P = NS). Predictors of limb loss by Cox proportional hazards models included end-stage renal disease (hazard ratio [HR], 8.563; P < .001) and poor pedal outflow, with an incremental protective effect for improved pedal outflow (HR, 0.205; P < .001 for one pedal outflow vessel; HR, 0.074; P < .001 for ≥ two pedal outflow vessels). Gender, smoking, diabetes, Rutherford score, runoff score, thrombosed popliteal aneurysm, and PMT were not significant predictors of limb loss. The use of PMT was a significant predictor of technical success (odds ratio, 2.67; P = .046). CONCLUSIONS: Endovascular therapy with thrombolysis using tissue plasminogen activator remains an effective treatment option for patients presenting with mild or moderate lower extremity ALI, with equal benefit derived with CDT or PMT. Patients with end-stage renal disease or poor pedal outflow have an increased risk of limb loss and may benefit from alternative revascularization strategies.

Endoscopic versus open saphenous vein graft harvest for lower extremity bypass in critical limb ischemia.

OBJECTIVE: Endoscopic vein harvest (EVH) has been demonstrated to improve early morbidity when compared with conventional open vein harvest (OVH) technique for infrainguinal bypass surgery. However, recent literature suggests conflicting results regarding mid- and long-term patency with EVH. The purpose of this study is to compare graft patency between harvest techniques specifically in patients with critical limb ischemia. METHODS: This retrospective study compared two groups of patients (EVH = 39 and OVH = 49) undergoing lower extremity revascularization from January 2009 to December 2011. Outcome measures included patency rates, postoperative complications, and wound infection. Graft patency was assessed using Kaplan-Meier curves. RESULTS: Both groups were matched for demographics and indications for bypass (critical limb ischemia). Median follow-up was 22 months. There was a significant reduction in the incidence of wound infection at the vein harvest site in the EVH group (OVH = 20%; EVH = 0%; P < .001), nevertheless, the difference was not significant when only the anastomotic sites were included (OVH = 12.2%; EVH = 15.4%; P = .43). The hospital length of stay was comparable between the two groups (EVH = 8.73 ± 9.69; OVH = 6.35 ± 3.28; P = .26) with no significant difference in the recovery time. Primary graft patency rate was 43.2% in the EVH group and 69.4% in the OVH group (P = .007) at 3 years. The most common reason for loss of primary patency was graft occlusion (61.5%) in the OVH group and vein graft stenosis (54.5%) in the EVH group. The average number of vascular reinterventions per bypass graft was significantly lower in the OVH group compared with the EVH group (OVH = 0.37; EVH = 1.28; P < .001). CONCLUSIONS: Our findings demonstrate inferior primary patency when using the technique of EVH. Additionally, we identified a significantly higher rate of reintervention in the EVH cohort as well as a higher rate of vein graft body stenosis. However, EVH was associated with a decreased rate of wound complications with similar limb salvage and secondary patency rates when compared to OVH. EVH should therefore be selectively utilized in patients at high risk for wound complications.

Patterns of femoropopliteal recurrence after routine and selective stenting endoluminal therapy.

OBJECTIVE: This study determined the incidence and characteristics of recurrent disease after femoropopliteal angioplasty, following either selective or routine stenting of diseased site(s). METHODS: Retrospective analysis of a prospectively maintained database for femoropopliteal interventions from June 2003 to July 2010 was performed. Interventions during this period were from a single institution, followed up at 1, 3, and 6 months after initial intervention and on a semiannual basis thereafter with clinical examinations and duplex ultrasound imaging. Two groups were identified: those with routine stenting (RS; routine stenting for all diseased areas) and those with selective stenting (SS; selective stenting for only segments which exhibited compromised flow from residual stenosis or significant dissection). Patients who developed recurrent symptoms (claudication, rest pain), a decrease in ankle-brachial index (ABI) (>0.2), or duplex documentation of a significant (>80%) recurrent stenosis underwent reintervention. Patient demographics, comorbidities, Trans-Atlantic Inter-Society Consensus (TASC) II classification, runoff, and degree of calcification (none, mild, moderate, severe) at initial intervention were recorded. The time to reintervention and recurrence pattern were recorded for both groups. RESULTS: During the study period, 746 endovascular interventions in 477 patients were performed. Total reintervention rate, including bypass, amputation, and asymptomatic occlusion after initial intervention, was 36.48% (group SS, 42.9%; group RS, 33.1%; P=.04). Of all initial interventions, 182 endovascular reinterventions in 165 patients for recurrent femoropopliteal disease were identified (group SS, 70; group RS, 95). No differences were noted among the groups in gender, comorbidities, initial TASC II classification, run off, calcification scores, or statin or clopidogrel use, or both. Time to recurrence was similar in the RS and SS groups. TASC II classification, runoff score, and degree of calcification were similar between the two groups. Although not statistically significant, analysis of recurrence pattern demonstrated de novo stenosis was more common in the SS group (50.0% vs 34.7%; P=.06). CONCLUSIONS: This single-center retrospective study found a significant difference in the incidence of recurrence requiring reintervention between patients treated with selective and routine stenting for femoropopliteal disease. Analysis of endovascular reinterventions, however, reveals no significant difference in recurrence time or recurrence pattern between the two groups. No significant differences were identified in time to recurrence, TASC II classification, runoff, and calcification of endovascular reinterventions between the two groups' end points. Additional prospective studies to evaluate the roles of routine and selective stenting in symptomatic femoropopliteal peripheral arterial disease and to investigate recurrence lesion characteristics and the patency of multiple endovascular interventions between these two groups are needed.

Synchronous and metachronous thoracic aneurysms in patients with abdominal aortic aneurysms.

OBJECTIVE: Although the association of thoracic aortic aneurysm (TAA) with abdominal aortic aneurysm (AAA) is known, the exact magnitude of the association has not been described. Our goal was to quantify the incidence of TAA in patients with an AAA and assess predictive factors for its diagnosis. METHODS: This was a retrospective review of all patients diagnosed with AAA from 2000-2008. The subsequent development or diagnosis of a TAA was noted and the association between AAA and TAA described. RESULTS: A total of 2196 patients with an AAA were reviewed. 1082 (49.3%) had a chest computed tomography (CT) during follow-up. 117 patients (10.8%) had a synchronous and 136 (12.6%) a metachronous TAA. Mean time to diagnosis was 2.3 years. Mean diameter was 4.7 ± 1.4 cm for AAA, and 4.7 ± 1.0 for TAA. Indications for the chest CT were variable. Most common were AAA (15%), pulmonary embolus (14%), and lung cancer (11%). Only 38% of AAAs and 14% of TAAs were repaired during the study period. Of all patients with known AAA who were found to have a TAA, 61/253 (24%) underwent repair, had a rupture, or had a TAA >5.5 cm. At a mean follow-up of 43.6 months, there were 79 deaths (7%): 7 AAA-related and 13 from TAA ruptures. Predictors of TAA diagnosis by logistic regression include African American race (odds ratio [OR] = 1.8; P = .02), family history of TAA (OR = 7.6; P = .04), hypertension (OR = 1.7; P = .006), and obesity (OR = 1.7; P = .006). Diabetes, infrarenal AAA location, and smoking have a negative association. CONCLUSIONS: TAAs are relatively common in patients with AAA. Routine or targeted screening with a chest CT at the time of AAA diagnosis may be indicated.

Impact of endovascular options on lower extremity revascularization in young patients.

OBJECTIVE: This study assessed outcomes of revascularization strategies in young patients with premature arterial disease. METHODS: Lower extremity revascularization outcomes from 2000 to 2008 were retrospectively compared among consecutive patients with comparable indications and procedures: age <50 years (group A) at the time of revascularization, 51 to 60 years (group B), and >60 years (control group C). Patency, limb salvage, and survival by limb or patient level were assessed by Kaplan-Meier and Cox proportional hazards analyses. RESULTS: A total of 409 limbs in 298 patients were treated: 44% for claudication and 56% for critical limb ischemia (CLI). Group A patients were more likely to be smokers and have a hypercoagulable state but less likely to have diabetes and renal failure. Treatment indications were comparable among groups, and procedures were equally distributed between open surgical and endovascular interventions. Two perioperative deaths occurred in group C (2%). Mean follow-up was 29 months, and 16% of claudicant patients in group A progressed to CLI (B, 3%; C, 2%; P < .001). Overall, 2-year primary, primary assisted, and secondary patency were significantly lower in group A (50.5%, 65.2%, 68.2%; P = .045) vs B (65.7%, 81.4%, 86.8%; P = .01) and C (57.9%, 78.9%, 83.9%; P < .001). Claudicant patients in group A had an unexpectedly low 2-year freedom from major amputation after intervention of only 90%. Results were more comparable across groups for CLI. The 2-year freedom from reintervention was similar (A, 81.0%; B, 78.9%; C, 83.5%), irrespective of the indication for intervention (P = .60). Younger patients had a significantly higher 3-year survival (A, 89.5%; B, 85.3%) compared with patients aged >60 years (C, 71.4%; P = .005). The 2-year freedom from major amputation rate was significantly lower in claudicant patients in group A vs C undergoing endovascular revascularization (P = .002), but not in patients treated with open revascularization (P = .40). Predictors of loss of primary patency included age <50 years (P = .003), endovascular revascularization (P = .005), and progression from claudication to CLI (P < .001). Age <50 years was also an independent predictor of limb loss vs age >60 years (P = .05). CONCLUSIONS: Endovascular options are commonly being used in young patients, especially those with claudication, but patency rates and outcomes remain very poor.

Impact of gender and age on outcomes of tibial artery endovascular interventions in critical limb ischemia.

BACKGROUND: Female sex and older age are known risk factors for adverse outcomes in peripheral artery disease. This study reports on the outcomes of tibial artery endovascular intervention (TAEI) by age and gender in patients treated for critical limb ischemia. METHODS: All TAEIs for tissue loss or rest pain (Rutherford classes 4, 5, and 6) from 2004 to 2010 were retrospectively reviewed. Patient demographics, comorbidities, intervention sites, complications, and outcome measurements, including limb salvage, wound healing, and patency, were recorded for each patient. Data were analyzed by gender and age using Fisher exact test, multivariate logistic regression, and Cox proportional hazards regression. RESULTS: Two hundred twenty-one limbs (201 patients, 40% female) were treated for critical limb ischemia (74% with tissue loss, 26% with rest pain). Mean age of the patients was 73.3 years (39% were aged ≥80 years). Comorbidities and indications for intervention were comparable. Isolated TAEI was performed in 46% of the limbs, whereas multilevel interventions were performed in 54%. Mean follow-up period was 8.7 ± 7.3 months. Complications were comparable between genders and ages (P = not significant [NS]). Limb salvage rate was 88% and was comparable by gender (P = NS). Major amputation was less frequent in octogenarians (6% vs. 16%, P = 0.03). Neither gender nor age was a predictor of limb loss (P = NS), but renal insufficiency was (hazard ratio = 2.81, 95% confidence interval = 1.14-6.90, P = 0.02). Age ≥80 years was a predictor of impaired wound healing (hazard ratio = 1.57, 95% confidence interval = 1.04-2.37, P = 0.03), but gender was not (P = NS). Overall primary patency rate was 62% at 1 year and was similar in women and octogenarians (P = NS). Overall reintervention rate was 53% at 1 year and was higher in women (65% vs. 46%, P = 0.03), but was not affected by age (P = NS). CONCLUSIONS: TAEI outcomes do not appear to be adversely affected by gender or age. Limb salvage appears equivalent in octogenarians, with amputations occurring less frequently. Women also appear to have outcomes similar to men after TAEIs, but may require repeat interventions to achieve equivalent limb salvage rates.

Long-term outcomes of internal carotid artery dissection.

OBJECTIVE: The natural history of acute carotid artery dissection is poorly characterized. The purpose of this study is to report on single institutional long-term outcomes. METHODS: A retrospective review of patients treated for acute spontaneous or posttraumatic carotid artery dissection over a 20-year period from August 1989 to July 2009 was performed. RESULTS: Twenty-nine patients with a mean age of 47 ± 19.6 years were identified with acute carotid dissection. Six (25%) were related to trauma, while 23 (79%) were spontaneous. Neurologic symptoms included contralateral limb weakness (55%), facial pain (35%), and Horner's syndrome (21%). Eight patients (28%) presented with an acute hemispheric stroke. Diagnostic imaging modalities used included computed tomography angiography (52%), magnetic resonance angiography (41%), and conventional angiography (48%). Twenty percent of patients had complete carotid occlusion and 25% had near occlusion. Most dissections (65%) had intracranial extension, and 35% were limited to the extracranial cervical internal carotid. The majority (96%) of patients were treated conservatively with anticoagulation or antiplatelet therapy or both. One patient underwent stenting for persistent symptoms resulting in complete recovery. There were two deaths, one from unrelated traumatic injuries and the other from unknown causes. Long-term follow-up was available for 20 patients: 14 had complete symptom resolution (70%) and five (25%) had partial clinical symptom resolution. Two patients had initial resolution of symptoms, with subsequent recurrence that was successfully managed conservatively. Follow-up imaging revealed luminal patency in 79% of patients with minimal residual stenosis. Two patients developed a small asymptomatic internal carotid aneurysm that did not require treatment. Mean follow-up was 1133.2 days. CONCLUSIONS: Most cervical carotid dissections can safely be conservatively managed, with the majority achieving anatomic and symptomatic resolution, with low rates of recurrence over long-term follow-up.

Multilevel versus isolated endovascular tibial interventions for critical limb ischemia.

OBJECTIVE: Endovascular interventions for critical limb ischemia (CLI) continue to have variable reported results. The purpose of this study is to determine the effect of disease level and distribution on the outcomes of tibial interventions. METHODS: A retrospective analysis of all tibial interventions done for CLI between 2006 and 2009 was performed. Outcomes of isolated tibial (group I) and multilevel interventions (group II) (femoropopliteal and tibial) were compared. RESULTS: Endovascular interventions were utilized to treat 136 limbs in 123 patients for CLI: 54 isolated tibial (85% tissue loss), and 82 multilevel (80% tissue loss). Mean age and baseline comorbidities were comparable. The mean ankle-brachial index (ABI) was significantly lower prior to intervention in group II (0.53 vs 0.74; P < .001) but was similar postintervention (0.86 vs 0.88; P = NS). Wound healing or improvement was achieved in 69% in group I and in 87% in group II (P = .05). Mean overall follow-up was 12.6 ± 5.3 months. Time to healing was significantly longer in group I: 11.5 ± 8.8 months vs 7.7 ± 6.6 months (P = .03). Limb salvage was achieved in 81% of group I and 95% of group II (P = .05). The rate of reintervention was similar (13% vs 18%, P = NS), so was the rate of late surgical conversion (0% vs 6%; P = NS). Limb loss resulted from lack of conduit or initial target vessel for bypass and high-risk systemic comorbidities. Overall mortality rates were similar among both groups. An isolated tibial intervention was a predictor of limb loss at 1 year on multivariate analysis and resulted in a lower rate of limb salvage at 1 year compared with multilevel interventions. Additionally, despite comparable primary patency rates, there was improved secondary patency with multilevel interventions compared with the isolated tibial interventions. Predictors of limb loss in patients treated with isolated tibial intervention included multiple synchronous tibial revascularization (P = .005) and advanced coronary artery disease requiring revascularization (P = .005). CONCLUSIONS: Adequate rates of limb salvage can be achieved in patients undergoing multilevel interventions for CLI, and improved patency is seen with multilevel compared to isolated tibial interventions. Patients with isolated tibial disease appear to have a higher incidence of limb loss secondary to poor initial pedal runoff, more extensive distal disease, and severe comorbidities precluding surgical bypass. Other therapeutic strategies should be considered in these patients, including primary amputation or pedal bypass when applicable.

True lumen re-entry after extravascular recanalization of a superficial femoral artery chronic total occlusion.

A 66-year-old man was treated for disabling right leg calf claudication with angioplasty and stenting of a chronically occluded superficial femoral artery. During attempted subintimal passage, the guidewire tracked extralumenally, which was not recognized, but it was successfully redirected into the true lumen distal to the occlusion with the use of the Outback (Cordis Endovascular, Miami Lakes, Fla) re-entry device. A bare metal nitinol stent was initially deployed extralumenally in the perivascular soft tissue. The patient returned for reintervention 9 days later complaining of pain and discoloration of the popliteal space. Duplex evaluation of the superficial femoral artery revealed a pseudoaneurysm, and Viabahn stent grafts (W. L. Gore & Assoc, Flagstaff, Ariz) were successfully deployed to produce an endovascular percutaneous prosthetic bypass.

Endovascular interventions for TASC II D femoropopliteal lesions.

BACKGROUND: Advances in endovascular techniques have provided new options in the treatment of complex infrainguinal occlusive lesions. The purpose of this study was to evaluate outcomes of endovascular interventions on TransAtlantic InterSociety (TASC) II D femoropopliteal occlusive disease. METHODS: All patients undergoing endovascular interventions for femoropopliteal occlusive disease between July 2004 and July 2009 were reviewed. Patient demographics, pre- and postprocedure ankle-brachial indices (ABI) and anatomic factors were analyzed. Outcomes evaluated included primary patency, assisted-patency, secondary patency, predictors of restenosis, and wound healing. RESULTS: Five hundred eighty-five limbs were treated during the period reviewed. The study group included 79 TASC D limbs in 74 patients (mean age 76.5 +/- 11.9 years, male sex: 53%). Fifty-six limbs (71%) underwent treatment for critical limb ischemia, including 42 (53%) with tissue loss. Eleven patients (15%) had previous failed bypasses. Preoperative ABIs were unobtainable for 23 patients, while the remaining 56 had a mean baseline ABI of 0.54 +/- 0.28. There was one periprocedural mortality. Five patients (6.3%) had periprocedural complications. Mean increase in ABI postprocedure was 0.49 +/- 0.35. Follow-up was available for 74 limbs at a mean of 10.7 months (range, 1-35). There were 18 mortalities (24.3%) during the follow-up period. No patient required a major amputation during this follow-up period. Twenty-one limbs (26.6%) experienced restenosis and nine limbs (11.4%) experienced occlusion. Twenty-nine limbs underwent reintervention during the follow-up time, including nine which underwent multiple reinterventions. Primary, assisted-primary, and secondary patency rates at 12 and 24 months were 52.2%, 88.4%, 92.6% and 27.5%, 74.2%, and 88.9%, respectively. Predictors of restenosis/occlusion included hypercholesterolemia, the presence of a popliteal artery stent, and patients who were current or former smokers. CONCLUSIONS: Endovascular interventions for TASC II D lesions can be safely performed with excellent hemodynamic improvement and limb salvage rates. Restenosis is not uncommon in this population, which mandates strict follow-up. Further follow-up is necessary to determine the long-term efficacy of these interventions.

Predictors of failure and success of tibial interventions for critical limb ischemia.

OBJECTIVE: The efficacy of tibial artery endovascular intervention (TAEI) for critical limb ischemia (CLI) and particularly for wound healing is not fully defined. The purpose of this study is to determine predictors of failure and success for TAEI in the setting of CLI. METHODS: All TAEI for tissue loss or rest pain (Rutherford classes 4, 5, and 6) from 2004 to 2008 were retrospectively reviewed. Clinical outcomes and patency rates were analyzed by multivariable Cox proportional hazards regression and life table analysis. RESULTS: One hundred twenty-three limbs in 111 patients (62% male, mean age 74) were treated. Sixty-seven percent of patients were diabetics, 55% had renal insufficiency, and 21% required hemodialysis. One hundred two limbs (83%) exhibited tissue loss; all others had ischemic rest pain. All patients underwent tibial angioplasty (PTA). Tibial excimer laser atherectomy was performed in 14% of the patients. Interventions were performed on multiple tibial vessels in 20% of limbs. Isolated tibial procedures were performed on 50 limbs (41%), while 73 patients had concurrent ipsilateral superficial femoral artery or popliteal interventions. The mean distal popliteal and tibial runoff score improved from 11.8 ± 3.6 to 6.7 ± 1.6 (P < .001), and the mean ankle-brachial index increased from 0.61 ± 0.26 to 0.85 ± 0.22 (P < .001). Surgical bypass was required in seven patients (6%). The mean follow up was 6.8 ± 6.6 months, while the 1-year primary, primary-assisted, and secondary patency rates were 33%, 50%, and 56% respectively. Limb salvage rate at 1 year was 75%. Factors found to be associated with impaired limb salvage included renal insufficiency (hazard ratio [HR] = 5.7; P = .03) and the need for pedal intervention (HR = 13.75; P = .04). TAEI in an isolated peroneal artery (odds ratio = 7.80; P = .01) was associated with impaired wound healing, whereas multilevel intervention (HR = 2.1; P = .009) and tibial laser atherectomy (HR = 3.1; P = .01) were predictors of wound healing. In patients with tissue loss, 41% achieved complete closure (mean time to healing, 10.7 ± 7.4 months), and 39% exhibited partial wound healing (mean follow up, 4.4 ± 4.8 months) at last follow up. Diabetes, smoking, statin therapy, and revascularization of > 1 tibial vessel had no impact on limb salvage or wound healing. Re-intervention rate was 50% at 1 year. CONCLUSIONS: TAEI is an effective treatment for CLI with acceptable limb salvage and wound healing rates, but requires a high rate of reintervention. Patients with renal failure, pedal disease, or isolated peroneal runoff have poor outcomes with TAEI and should be considered for surgical bypass.