Nutrition in Peritoneal Dialysis.

The use of peritoneal dialysis (PD) has been associated with improved quality of life, cost-effectiveness, and better outcomes for patients with kidney failure. However, many patients utilizing PD for replacement therapy face numerous nutritional hurdles. As the use of PD continues to increase worldwide, malnutrition has become an increasingly recognized concern for patients undergoing PD. The nephrology community needs to recognize and treat malnutrition to promote optimal nutritional states for our patients. In this review, we discuss several factors that contribute to malnutrition and protein-energy wasting and explore the benefits and limitations of nutritional parameters used to assess protein-calorie malnutrition. We also emphasize updated guidelines on daily caloric, protein, and micronutrient recommendations, as well as their effects on electrolyte homeostasis.

Auryon Laser in Peripheral Arterial Interventions: A Single-Center Experience (Auryon-SCE).

BACKGROUND: The Auryon 355-nm laser atherectomy system (AngioDynamics, Inc) showed a low rate of target-lesion revascularization (TLR) at 6-month follow-up in the investigational device exemption study. At present, real-world data are not available. In this study, we analyze major adverse events and 6-month outcomes with the Auryon laser system in treating infrainguinal arterial disease in all comers at a single center. METHODS: Consecutive patients treated with the Auryon laser between September 2017 and March 2021 were retrospectively reviewed from a single operator at a single center. Demographic, procedural, angiographic, and outcome data were extracted from patients' medical records. Descriptive and survival analyses were performed. The study's primary endpoint was the assessment of freedom from TLR at 6-month follow-up. Secondary endpoints included acute procedural results, distal embolization, bailout stenting (dissection type D or higher by National Heart, Lung, and Blood Institute [NHLBI] classification, and/or residual narrowing >30%), unplanned major amputation, death, or vascular complications. RESULTS: A total of 56 patients (65 procedures, 70 lesions) were enrolled. The mean age was 70.9 ± 10 years, 66.1% were males, 48.2% were diabetics, and 25% had limb ischemia. Of the 70 lesions, 31.4% had severe calcification, 38.6% were chronic total occlusions, and 48.6% were de novo disease (in-stent restenosis in 28.6%). The majority of treated vessels were femoropopliteal (88.6%) and 29.2% had 2 or more prior interventions. Mean stenosis was 91.3 ± 9.7% at baseline, 56.0 ± 17.3% post laser, and 11.4 ± 11.2% post final treatment. Lesion length was 117.1 ± 101.2 mm and treated length was 174.0 ± 116.0 mm. Bailout stenting occurred in 11/70 lesions (15.7%). There were no NHLBI type D dissections post laser and 1 type D dissection post laser + percutaneous transluminal angioplasty. A total of 47.1% received Lutonix drug-coated balloons (BD/Bard), 27.1% received In.Pact drug-coated balloons (Boston Scientific), and 1.4% received both. The probability of freedom from TLR per procedure was 95.6% at 6 months. CONCLUSION: In a real-world cohort of patients with complex disease, the Auryon laser had excellent freedom from TLR at 6 months, although these findings need to be replicated in a randomized trial.

Venovo Venous Stent in Treating Iliac Vein Compression: A Single-Center Experience.

BACKGROUND: The Venovo venous stent (BD/Bard Peripheral Vascular) is indicated to treat iliofemoral veno-occlusive disease. We present our own experience with the Venovo venous stent in treating iliac vein compression (ILVC). METHODS: In this retrospective cohort, we included consecutive patients treated with the Venovo venous stent for ILVC at our center. Stent deployment and sizing were guided by intravascular ultrasound (IVUS). Minimal luminal areas at the compression before and after treatment were measured by IVUS. Clinical improvement was determined by symptoms reported by patients and the Clinical Etiologic Anatomic and Pathophysiologic (CEAP) score. The primary safety endpoint was freedom from acute venothromboembolic disease, stent migration, perforation, acute/subacute closure, and vascular complications. The primary safety endpoint was target-lesion revascularization at 1 year. RESULTS: A total of 50 consecutive patients (57 Venovo stents, 36 women, mean age, 59.8 ± 16.3 years) were included. IVUS-measured mean percent stenosis at the compression site was 64.8% ± 12.8%. Mean total stent length and diameter were 78.0 ± 54.0 mm and 17.1 ± 1.9 mm, respectively. The primary safety endpoint was met in all subjects. Procedural technical success was 100% (successful deployment with no complications). At 1 year, 83.8% of patients reported improvement in their symptoms. Freedom from total occlusion at 1 year was 100% (data available for n = 30 patients). Target-lesion revascularization (TLR) was 2% at 1 year due to 1 patient who had stent explantation from worsening ipsilateral left leg and back pain. CONCLUSION: In this single-center experience, the Venovo venous stent was safe and effective in treating ILVC with 98% freedom from TLR at a follow-up of 1 year. Improvement in symptoms was reported in the majority of patients.

Predicting Significant Iliac Vein Compression Using a Probability Scoring System Derived From Minimal Luminal Area on Computed Tomography Angiography in Patients 65 Years of Age or Younger.

BACKGROUND: The presence of 50% or more stenosis on intravascular ultrasound (IVUS) is considered diagnostic of iliac vein compression (ILVC) by most operators. We have previously developed a scoring system combining minimal luminal area (MLA) at the compression site and age to predict ILVC as seen on IVUS. We present a revised and improved scoring system following an additional number of patients and limited to patients 65 years of age and younger. METHODS: Patients were included from retrospective (n = 52) and prospective (n = 18) registries of consecutive patients who underwent computed tomography angiography (CTA) of the pelvis with venous filling and IVUS within a few weeks apart to evaluate for symptomatic ILVC at a single cardiovascular practice. Quantitative vascular analysis was performed on all images obtained. MLA and age were used to calculate a score derived from a previously published logistic regression formula. Patients >65 years in age were excluded. The predicted findings from the score were compared with the actual presence of compression on IVUS. The revised scoring system is based on a score of < or ≥ 0.533824 and MLA (mm²) of <140, ≥140 to <200, and ≥200. The negative predictive value (NPV) and positive predictive value (NPV and PPV) of each cut-off in predicting ILVC on IVUS were calculated. RESULTS: A total of 70 symptomatic patients were included (mean age, 52.6 ± 12.3 years). The model offered the following: accuracy = 54/70 (77.1%); sensitivity = 51/52 (98.1%); specificity = 3/18 (16.7%); PPV = 51/66 (77.3%); and NPV = 3/4 (75.0%). CONCLUSION: A scoring system using MLA on CTA and age provides a fairly accurate diagnostic test to predict the presence of significant ILVC as seen on IVUS.

Two-Year Outcomes of Endovascular Interventions of the Common Femoral Artery: A Retrospective Analysis From Two Medical Centers.

BACKGROUND: Treatment of common femoral artery (CFA) disease has been traditionally surgical. Recent data indicate that an endovascular option is feasible in treating CFA disease but there remains significant controversy about the endovascular versus surgical approach to treatment. Newer modalities of therapy have emerged to treat the CFA including atherectomy and drug coated balloons. We retrospectively reviewed data on the long-term outcome of endovascular treatment of CFA from 2 medical centers. METHODS: Consecutive patients with CFA disease treated by 6 operators using endovascular techniques from January 1, 2012 to December 31, 2017 were reviewed and analyzed. Two-year follow up was completed using medical records. Demographic, clinical, procedural and angiographic variables were collected. The primary endpoint of the study was target lesion revascularization (TLR). Secondary endpoints included target vessel revascularization (TVR), mortality, unplanned major and minor amputations and 30-day periprocedural adverse events. Descriptive analysis was performed on all variables. Kaplan-Meier for freedom from TLR was plotted. The study was approved by the Ethics Committee at our center. RESULTS: A total of 89 patients (116 limbs) were included at Index. There were males 57.3%, diabetics 42.7%. Mean age was 65.1 ± 16.3 years. Critical limb ischemia (CLI) was present in 27.7%. Disease distribution was classified by the Medina classification: 1-0-0 (CFA only) 48.3%, 1-0-1 (CFA + profunda) 6.9%, 1-1-1 (CFA+ profunda + origin of superficial femoral artery) 16.4%, 1-1-0 (CFA and origin of SFA) 28.4%. Denovo disease was present in 70.7%. Atherectomy was used in 104/116 limbs (89.7%). Drug coated balloons (DCB) in 15.5%, and stenting in 22.4%. Baseline stenosis 81.2 ± 13.1%, lesion length was 42.0 ± 14.5 mm. Final stenosis was 13.3 ± 11.0. Major bleeding occurred in 2.6%. At 2-year mortality was 9.0% (none related to procedure), CLI was 5.9% and no unplanned major or minor amputations. At 2-year KM analysis showed a probability of freedom from TLR of 72.2%. At 2-year the following TLRs were noted for various devices used: PTA 50%, orbital atherectomy 0%, jetstream 29.2%, laser 36.4%, and SilverHawk/TurboHawk 23.1% (p = 0.0476). CONCLUSION: Endovascular treatment of CFA predominantly with atherectomy in this cohort, is feasible and with acceptable outcomes considering a low percentage of DCB use. A randomized trial is needed to validate these findings and explore the added role of DCB and atherectomy on clinical outcomes when compared to endarterectomy.

The Venovo Venous Stent in Pregnancy.

We present the case of a young woman who became pregnant following placement of a Venovo venous stent (BD/Bard) in her left common iliac vein. Our case illustrates the safety of the Venovo stent during pregnancy. This needs further validation with a larger registry.

Location of Dissections Post Balloon Angioplasty in Patients With Femoropopliteal Arterial Disease as Seen on Intravascular Ultrasound.

We reviewed images from our intravascular ultrasound core lab to define the various locations of dissections in femoropopliteal arteries post balloon angioplasty in relation to plaque morphology.

Predicting Iliac Vein Compression With Computed Tomography Angiography and Venography: Correlation With Intravascular Ultrasound.

BACKGROUND: Intravascular ultrasound (IVUS) is considered the gold standard in diagnosing common iliac vein (CIV) compression. The presence of >50% surface area reduction by IVUS is considered significant compression by most operators. Thus, we evaluated the role of computed tomography angiography (CTA) and venography in diagnosing CIV compression when compared to IVUS. METHODS: All patients who underwent CTA of the pelvis with venous filling phase, IVUS, and venography within a few weeks apart to evaluate for symptomatic CIV compression from one cardiovascular practice were retrospectively reviewed. Quantitative vascular analysis was performed on all images obtained to determine (1) percent stenosis (PS) by venogram; and (2) minimal lumen area (MLA) and PS by CTA and IVUS at the compression site (using ipsilateral distal CIV as reference area). Spearman's rank correlation, paired t-tests, or signed rank tests were performed as appropriate to compare between values of MLA and PS among the three different imaging modalities. RESULTS: A total of 96 patients were included (62.5% females; mean age, 62.3 ± 14.8 years). A significant correlation was found between MLA-CTA and MLA-IVUS (Spearman's rho, 0.27; P=.01) and PS-CTA and PS-IVUS (Spearman's rho, 0.327; P<.01). A significant correlation was also found between PS-venogram and PS-IVUS (Spearman's rho, 0.471; P<.001). MLA-CTA and MLA-IVUS had a median difference of +41 mm² (95% CI, 25.0-57.5; P<.001) whereas PS-CTA and PS-IVUS were not statistically different (median difference, -5.6 mm²; 95% CI, -12.2 to 0.7). Furthermore, PS-IVUS and PS-venogram had a median difference of +15.2% (95% CI, 10.4-20.1; P<.001). CONCLUSION: PS-venogram correlates with PS-IVUS, but venogram underestimates the PS by an average of 15.2%. In contrast, PS-CTA and PS-IVUS are not statistically different despite an over-estimation of MLA by CTA when compared to IVUS. Therefore, we conclude that PS-CTA and not PS-venogram can be used to predict PS on IVUS.

Long-term outcomes with Jetstream atherectomy with or without drug coated balloons in treating femoropopliteal arteries: A single center experience (JET-SCE).

BACKGROUND: The long-term outcome of Jetstream atherectomy (JA) with or without adjunctive drug coated balloons (DCB) in a real-world setting remains unknown. We report 16-month target lesion revascularization (TLR) rates on patients treated for femoropopliteal (FP) artery disease with JA in a single center by one operator. METHODS: From 1/1/12 to 8/24/16 a total of 311 procedures were performed with atherectomy by a single operator at a single center. Of these procedures, 75 met inclusion and exclusion criteria. This report evaluates the outcomes of these 75 patients treated at index and who were followed up to 16 months. The primary endpoint of the study was clinically driven TLR. Patients were stratified by the use of DCB (vs angioplasty (PTA)) post-JA. TLR was calculated by excluding bailout stenting as TLR. Survival analysis for TLR over time was plotted. RESULTS: 75 patients (49.3% male, mean age 68.0 years, 54.7% diabetes) with de novo or restenotic FP lesions whose symptoms were classified as Rutherford category I-V were enrolled. Adjunctive PTA was performed on 50 patients (26 de novo, 13 in-stent restenosis, 3 non-stent restenosis, 8 mixed lesions) and adjunctive DCB (LUTONIX® 24, IN.PACT® 1) on 25 patients (21 de novo, 1 in-stent restenosis, 2 non-stent restenosis, 1 mixed lesion) (p = 0.0249). There was no difference in the median treated length between the adjunctive PTA (15 cm) and DCB (10 cm) groups (p = 0.0530). The estimated freedom from TLR (fTLR) was significantly higher with atherectomy and adjunctive DCB compared to atherectomy with adjunctive PTA at 12 months (94.7% vs 68.0%, p = 0.002) and 16 months (94.4% vs 54%; p = 0.002). CONCLUSIONS: In a single center cohort of JA reflecting real-world practice, JA with DCB had a superior TLR rate up to 16-month follow-up when compared to JA with PTA in treating all comers FP arterial disease.

Five-Year Freedom From Target-Lesion Revascularization Using Excimer Laser Ablation Therapy in the Treatment of In-Stent Restenosis of Femoropopliteal Arteries.

BACKGROUND: Target-lesion revascularization (TLR) and loss of patency remain high following treatment of in-stent restenosis (ISR) of the femoropopliteal (FP) artery. Excimer laser atherectomy (ELA) is effective in reducing TLR and improves patency at 6-month and 1-year follow-up when compared with balloon angioplasty (PTA). The long-term sustainability of these early results is unknown. We present a retrospective analysis from our center on the 5-year outcomes of ELA in the treatment of ISR of the FP arteries. METHODS: Patients who underwent ELA for FP-ISR from February 2005 to April 2010 at a single medical center were included. Demographics, angiographic and procedural variables were included. Major adverse events and 5-year TLR and target-vessel revascularization were obtained from medical records. Descriptive analysis was performed on all variables. Kaplan-Meier survival curves for TLR were plotted censored for death among patients who died before the occurrence of a TLR. RESULTS: Forty consecutive patients (mean age, 67.2 ± 9.0 years; 57.5% males) were included. Angiographic variables included: lesion length, 210.4 ± 104.0 mm; lesion severity, 93.9 ± 8.9%; and number of vessel runoffs, 1.7 ± 1.0. All patients were treated with adjunctive PTA. Acute procedural success was achieved in 92.5% of vessels. Distal embolization requiring treatment was 2.5%. No unplanned amputation occurred. Total deaths occurred in 8/40 (20%). At 5-year follow-up, TLR occurred in 62.5% with the steepest decline in freedom from TLR occurred in the first year followed by a less decline in the subsequent 2 to 3 years. CONCLUSION: ELA for FP-ISR continues to show progressive increase in TLR up to 5-year follow-up, but mostly occurs in the first 3 years after index procedure. These data suggest that a minimum follow-up of 3 years is needed to determine stability of treatment of FP-ISR with laser.

Major Limb Outcomes Following Lower Extremity Endovascular Revascularization in Patients With and Without Diabetes Mellitus.

PURPOSE: To determine whether diabetes mellitus has an independent impact on major limb outcomes at 1 year after endovascular treatment of lower extremity peripheral artery disease (PAD). METHODS: The study involved 1906 consecutive patients (mean age 66 years; 1469 men) enrolled in the observational Excellence in Peripheral Artery Disease (XLPAD) registry ( ClinicalTrials.gov identifier NCT01904851) between January 2005 and October 2015 after undergoing index endovascular procedures in 2426 limbs for arterial occlusive disease. Patient outcomes included 12-month target limb amputation (above ankle) and target limb revascularization as well as all-cause death. Kaplan-Meier analysis and adjusted Cox proportional hazard models were used for time-to-event analysis of outcomes for the entire study sample as well as for the critical limb ischemia (CLI) and claudication subgroups. Results of the Cox regression models are reported as the hazard ratio (HR) and 95% confidence interval (CI). RESULTS: Diabetics undergoing endovascular procedures had higher rates of comorbid conditions (p<0.001), CLI (p<0.001), heavily calcified lesions (p=0.002), multivessel disease (p=0.030), and fewer infrapopliteal runoff vessels (p<0.001). Regression analysis after adjusting for confounders revealed significantly higher target limb major amputation in diabetics compared with nondiabetics (HR 5.02, 95% CI 1.44 to 17.56, p=0.011). However, repeat revascularization rates were similar. When considering CLI and claudication subgroups, diabetes was associated with a nonsignificant increased risk of 12-month major amputation only for patients presenting with CLI (HR 3.48, 95% CI 0.97 to 12.51, p=0.056). Diabetes was also associated with an increased risk of 12-month all-cause mortality in the overall study sample (HR 4.64, 95% CI 2.01 to 10.70, p<0.001) and in the CLI subgroup (HR 14.15, 95% CI 3.16 to 63.32, p<0.001) but not in the claudication subgroup (HR 1.42, 95% CI 0.45 to 4.54, p=0.552). CONCLUSION: Diabetes increases the risk of major amputation and all-cause death at 12 months following endovascular revascularization in patients with symptomatic PAD. These risks are especially heightened in patients presenting with CLI.

Predictors of common femoral artery access site complications in patients on oral anticoagulants and undergoing a coronary procedure.

BACKGROUND: It is unclear whether patients on oral anticoagulants (OAC) undergoing a procedure using common femoral artery access have higher adverse events when compared to patients who are not anticoagulated at the time of the procedure. METHODS: We retrospectively reviewed data from consecutive patients who underwent a cardiac procedure at a tertiary medical center. Patients were considered (group A) fully or partially anticoagulated if they had an international normalized ratio (INR) ≥1.6 on the day of the procedure or were on warfarin or new OAC within 48 h and 24 h of the procedure, respectively. The nonanticoagulated group (group B) had an INR <1.6 or had stopped their warfarin and new OAC >48 h and >24 h preprocedure, respectively. The index primary end point of the study was defined as the composite end point of major bleeding, vascular complications, or cardiovascular-related death during index hospitalization. The 30-day primary end point was defined as the occurrence of the index primary end point and up to 30 days postprocedure. RESULTS: A total of 779 patients were included in this study. Of these patients, 27 (3.5%) patients were in group A. The index primary end point was met in 11/779 (1.4%) patients. The 30-day primary composite end point was met in 18/779 (2.3%) patients. There was no difference in the primary end point at index between group A (1/27 [3.7%]) and group B (10/752 [1.3%]; P=0.3155) and no difference in the 30-day primary composite end point between group A (2/27 [7.4%]) and group B (16/752 [2.1%]; P=0.1313). Multivariable analysis showed that a low creatinine clearance (odds ratio [OR] =0.56; P=0.0200) and underweight patients (<60 kg; OR =3.94; P=0.0300) were independent predictors of the 30-day primary composite end point but not oral anticoagulation (P=0.1500). CONCLUSION: Patients on OAC did not have higher 30-day major adverse events than those who were not anticoagulated at index procedure.

Safety and Effectiveness of Closure Devices Applied to a Stented Common Femoral Artery: A Retrospective Analysis.

Bailout stenting of the common femoral artery (CFA) may become necessary with failed balloon angioplasty or atherectomy or in case of bleeding requiring a covered stent over the arteriotomy site. Reaccessing the CFA through a previously placed stent may occur during angiography. The safety and effectiveness of applying a closure device, or manual compression to achieve hemostasis through an accessed stented CFA are unknown. All patients in our practice that underwent CFA stenting were identified using billing records for 3 years (January 1, 2010-February 28, 2013). Patients were included if there has been documentation of access through the stented CFA segment on angiography. In-hospital and up to 2 weeks postdischarge major adverse events were recorded from medical records. A total of 48 patients were included in the study. The mean age was 65.9 ± 10.9 years, males 60.4%. Perclose (Abbott Vascular, Santa Clara, CA) was used in 85.7%, AngioSeal (St. Jude Medical, St. Paul, MN) in 8.3%, Mynx (Access Closure, Santa Clara, CA) in 2%, and manual compression in 4% of the patients. Major adverse events consisted of in-hospital mortality in two patients: one probably related to index access-site thrombosis complicated by subsequent acute renal failure following reintervention; the other mortality was related to major bleeding possibly related to the index access site. The remaining patients had no adverse events and there were no reported problems at 2 weeks follow-up. Accessing and applying closure device in stented CFA can be accomplished successfully in approximately 96% of the patients with low major adverse events.

The learning curve in treating coronary chronic total occlusion early in the experience of an operator at a tertiary medical center: The role of the hybrid approach.

BACKGROUND: Treatment of chronic total occlusion (CTO) is complex and has a low adoption rate by interventional cardiologists. The introduction of the hybrid approach has provided a systematic step-by-step approach to treat complex CTO lesions with a high success rate. We describe the overall experience with the use of the hybrid approach of a non-CTO operator and analyze differences in the procedural and long term outcomes before and after the initial 30 cases performed. METHODS: A total of 67 unselected, consecutive patients (68 lesions) underwent PCI of a CTO between January 2012 and June 2013 by a non-CTO operator. Patients were followed up for 1year using office and hospital medical records and death certificates. Cases were divided into the first consecutive 30 patients and compared to the subsequent 37 patients. The primary endpoint was acute procedural success defined as residual narrowing of ≤30% with no major adverse events. Secondary endpoints included the independent outcomes of death, major bleeding, perforations with cardiac tamponade, acute stent thrombosis (ST), target lesion revascularization (TLR) and target vessel revascularization (TVR). Descriptive analysis was performed on all variables. Univariate analysis was used to compare both groups. RESULTS: Baseline characteristics were as follows: mean age 63.9±10.6years, males 80.6%, diabetes 41.8%, de novo lesions 100%, ejection fraction 49.9±13.8%, CTO length 76.9±45.7mm, number of drug eluting stents per CTO 2.8±1.6 (median 3), contrast use 397±161.3ml, fluoroscopy time 51±32min and procedure time 134.3±74.7min. Lesions were crossed using an antegrade approach in 70.6% and a combined retrograde/antegrade approach in 29.4%. Crossing was intraluminal in 83.8% and subintimal in 16.2%. Acute procedural success was 95.5%. MAE included pericardial effusion with tamponade in 4.5%. On follow-up, TLR occurred in 6.6% of patients and TVR in 13.1%. There were no definite ST, one (1.6%) probable ST and one (1.6%) possible ST. Cardiac death occurred in 4.8% and non-cardiac death 1.6%. When comparing early experience (first 30 cases) with subsequent one, there were no differences in CTO length (60±47.6mm vs 83.2±43.7mm, p=0.206) or coronary distribution of the CTO. The number of drug eluting stents used per CTO (2.6±1.7 vs 3.0±1.5, p=0.289), contrast use (401±141.2ml vs 393.7±177.8ml, p=0.856), fluoroscopy time (48.9±25.6min vs 52.9±36.5min, p=0.617), or procedure time (116.8±48.6min vs 148.5±88.7min, p=0.068) were statistically similar between the 2 groups. Less crossing catheters were used (1.1±1 vs 0.6±0.7, p=0.024) and more lesions were crossed via antegrade approach after the initial experience (antegrade crossing: 53.3% vs 84.2% respectively, p=0.008). There was numerically more procedural success after the initial experience (90 vs 100%, p=0.085). MAE, TLR and TVR were similar on 1year follow-up. CONCLUSION: A high success rate was seen using the hybrid approach to treat CTO by a non-CTO operator. Although less crossing catheters were used and more lesions were treated via the antegrade approach after the initial experience, procedural and long term outcomes were otherwise similar between the early versus the late experience.

Safety and One-Year revascularization outcome of excimer laser ablation therapy in treating in-stent restenosis of femoropopliteal arteries: A retrospective review from a single center.

BACKGROUND: Treatment of in-stent restenosis of the femoropopliteal (FP) arteries is challenging with a high rate of restenosis. Excimer laser atherectomy (ELA) has a theoretical advantage of ablating restenotic tissue and reducing or delaying the need for repeat revascularization. We present a retrospective analysis from our center on the outcomes of ELA in the treatment of in-stent restenosis of the FP arteries. METHODS: Demographic, clinical, angiographic and procedural data were collected on all patients that underwent ELA for in-stent restenosis from February 2005 to April 2010 at a single medical center. Major adverse events and one-year target lesion revascularization (TLR) and target vessel revascularization (TVR) were obtained by reviewing of medical records. Descriptive analysis was performed on all variables. Kaplan-Meier survival curves for TLR were plotted. RESULTS: 40 consecutive patients (mean age 67.7±9.0years, 57.5% males) were included and followed for 1year. Adjunctive balloon angioplasty was performed in 100% at a mean pressure of 12.4±2.9atm. Acute procedural success (<30% angiographic residual narrowing) occurred in 92.5% of patients. Embolic filter protection (EFP) was used in 57.5% of patients. Bailout stenting was 50.0%. Macrodebris was noted in 65.2% of filters. The following adverse events were reported: distal embolization (DE) requiring treatment 2.5% (1 patient with no EFP); planned minor amputation 2.6%, planned major amputation 2.6%, total death 7.7% (all cardiac related). One perforation occurred treated successfully with stenting and balloon inflation. At one year, TLR and TVR occurred in 48.7% and 48.7% respectively. CONCLUSION: ELA has an overall favorable acute result in treating in-stent restenosis of the FP arteries. At one year TLR and TVR remain clinically significant. DE also occurs significantly with ELA and is effectively prevented with EFP.

In-hospital safety and effectiveness of bivalirudin in percutaneous peripheral interventions: data from a real-world registry.

PURPOSE: To present real-world data to evaluate the safety and effectiveness of bivalirudin, a direct thrombin inhibitor, in an unselected group of patients undergoing percutaneous peripheral interventions (PPI). METHODS: Data were extracted from a prospectively collected peripheral vascular registry developed for quality assurance measures at 2 centers. Of 398 consecutive patients (195 men; mean age 69.4+/-11.3 years) who underwent PPI in a 2-year period, 369 (92.7%) received bivalirudin (0.75 mg/kg bolus followed by a 1.75 mg/kg/h infusion) and 29 (7.3%) received unfractionated heparin (UFH). In the bivalirudin sample, critical limb ischemia was present in 28.0% of patients, TASC D lesion in 29.5%, and angiographic thrombus in 7.8% of vessels. Demographic, clinical, procedural, and angiographic variables and in-hospital complications were analyzed. All in-hospital adverse events were independently adjudicated. RESULTS: Procedural success (<30% residual narrowing) was achieved in 359 (97.3%) patients receiving bivalirudin. Adverse events included stroke (1, 0.3%), acute renal failure (1, 0.3%), major bleeding (3, 0.8%), distal embolization (11, 3.0%), vascular access complications (2, 0.5%), and minor amputation (2, 0.5%). CONCLUSION: Bivalirudin had an excellent safety profile in a real-life cohort of patients undergoing PPI, including high-risk patients with critical limb ischemia and TASC D lesions. In-hospital major bleeding and other adverse events were infrequent. A randomized trial of bivalirudin versus UFH is needed to verify these results and establish bivalirudin as a standard anticoagulant in PPI.