Effect of Two Years of Doxycycline Treatment on Infrarenal Aortic Neck Diameter.

Objective: Endovascular aneurysm repair (EVAR) is a widely used option for patients with suitable vascular anatomy who have a large infrarenal abdominal aortic aneurysm (AAA). Neck diameter is the primary anatomical determinant of EVAR eligibility and device durability. Doxycycline has been proposed to stabilise the proximal neck after EVAR. This study explored doxycycline mediated aortic neck stabilisation in patients with small AAA, monitored by computed tomography over two years. Methods: This was a multicentre prospective randomised clinical trial. Subjects from the Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA3CT, NCT01756833) were included in this secondary a priori analysis. Female baseline AAA maximum transverse diameter was between 3.5 and 4.5 cm, and male was between 3.5 and 5.0 cm. Subjects were included if they completed pre-enrolment and two year follow up computed tomography (CT) imaging. Proximal aortic neck diameter was measured at the lowest renal artery, and 5, 10, and 15 mm caudal to this point; mean neck diameter was calculated from these values. Unpaired, two tailed parametric t test analysis with post hoc Bonferroni correction was used to detect differences between neck diameters in subjects treated with placebo vs. doxycycline at baseline and two years. Results: One hundred and ninety-seven subjects (171 male, 26 female) were included in the analysis. All patients, regardless of treatment arm, demonstrated larger neck diameter caudally, a slight increase in diameter at all anatomical levels over time, and greater growth caudally. There was no statistically significant difference in infrarenal neck diameter between treatment arms at any anatomical level at any time point, nor mean change in neck diameter over two years. Conclusion: Doxycycline does not demonstrate infrarenal aortic neck growth stabilisation in small AAA followed for two years by thin cut CT imaging using a standardised acquisition protocol and cannot be recommended for mitigation of growth of the aortic neck in patients with untreated small abdominal aortic aneurysms.

Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 Trial.

BACKGROUND: The SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial showed the safety but not efficacy of the Symplicity system (Medtronic, Santa Rosa, CA, USA) at 6 months follow-up in patients with treatment-resistant hypertension. This final report presents the 36-month follow-up results. METHODS: SYMPLICITY HTN-3 was a single-blind, multicentre, sham-controlled, randomised clinical trial, done in 88 centres in the USA. Adults aged 18-80 years, with treatment-resistant hypertension on stable, maximally tolerated doses of three or more drugs including a diuretic, who had a seated office systolic blood pressure of 160 mm Hg or more and 24 h ambulatory systolic blood pressure of 135 mm Hg or more were randomly assigned (2:1) to receive renal artery denervation using the single electrode (Flex) catheter or a sham control. The original primary endpoint was the change in office systolic blood pressure from baseline to 6 months for the renal artery denervation group compared with the sham control group. Patients were unmasked after the primary endpoint assessment at 6 months, at which point eligible patients in the sham control group who met the inclusion criteria (office blood pressure ≥160 mm Hg, 24 h ambulatory systolic blood pressure ≥135 mm Hg, and still prescribed three or more antihypertensive medications) could cross over to receive renal artery denervation. Changes in blood pressure up to 36 months were analysed in patients in the original renal artery denervation group and sham control group, including those who underwent renal artery denervation after 6 months (crossover group) and those who did not (non-crossover group). For comparisons between the renal artery denervation and sham control groups, follow-up blood pressure values were imputed for patients in the crossover group using their most recent pre-crossover masked blood pressure value. We report long-term blood pressure changes in renal artery denervation and sham control groups, and investigate blood pressure control in both groups using time in therapeutic blood pressure range analysis. The primary safety endpoint was the incidence of all-cause mortality, end stage renal disease, significant embolic event, renal artery perforation or dissection requiring intervention, vascular complications, hospitalisation for hypertensive crisis unrelated to non-adherence to medications, or new renal artery stenosis of more than 70% within 6 months. The trial is registered with ClinicalTrials.gov, NCT01418261. FINDINGS: From Sep 29, 2011, to May 6, 2013, 1442 patients were screened, of whom 535 (37%; 210 [39%] women and 325 [61%] men; mean age 57·9 years [SD 10·7]) were randomly assigned: 364 (68%) patients received renal artery denervation (mean age 57·9 years [10·4]) and 171 (32%) received the sham control (mean age 56·2 years [11·2]). 36-month follow-up data were available for 219 patients (original renal artery denervation group), 63 patients (crossover group), and 33 patients (non-crossover group). At 36 months, the change in office systolic blood pressure was -26·4 mm Hg (SD 25·9) in the renal artery denervation group and -5·7 mm Hg (24·4) in the sham control group (adjusted treatment difference -22·1 mm Hg [95% CI -27·2 to -17·0]; p≤0·0001). The change in 24 h ambulatory systolic blood pressure at 36 months was -15·6 mm Hg (SD 20·8) in the renal artery denervation group and -0·3 mm Hg (15·1) in the sham control group (adjusted treatment difference -16·5 mm Hg [95% CI -20·5 to -12·5]; p≤0·0001). Without imputation, the renal artery denervation group spent a significantly longer time in therapeutic blood pressure range (ie, better blood pressure control) than patients in the sham control group (18% [SD 25·0] for the renal artery denervation group vs 9% [SD 18·8] for the sham control group; p≤0·0001) despite a similar medication burden, with consistent and significant results with imputation. Rates of adverse events were similar across treatment groups, with no evidence of late-emerging complications from renal artery denervation. The rate of the composite safety endpoint to 48 months, including all-cause death, new-onset end-stage renal disease, significant embolic event resulting in end-organ damage, vascular complication, renal artery re-intervention, and hypertensive emergency was 15% (54 of 352 patients) for the renal artery denervation group, 14% (13 of 96 patients) for the crossover group, and 14% (10 of 69 patients) for the non-crossover group. INTERPRETATION: This final report of the SYMPLICITY HTN-3 trial adds to the totality of evidence supporting the safety of renal artery denervation to 36 months after the procedure. From 12 months to 36 months after the procedure, patients who were originally randomly assigned to receive renal artery denervation had larger reductions in blood pressure and better blood pressure control compared with patients who received sham control. FUNDING: Medtronic.

Stent Graft Outcomes in Dialysis Circuits: A Review of Clinical Trials and Literature.

End-stage renal disease is a prevalent medical condition causing significant problems as the majority of patients are being treated with dialysis. While dialysis provides a means to compensate for the renal impairment, arteriovenous grafts and fistulas are often complicated by neointimal hyperplasia, loss of primary patency, and graft failure. Over the last decade, stent grafts have emerged as an alternative to balloon angioplasty and bare metal stents for revascularization in the event of arteriovenous graft occlusion or stenosis. Several randomized controlled trials have investigated the efficacy of stent grafts compared with balloon angioplasty for improving the function and durability of dialysis circuits. In this review, we present a comprehensive review of clinical trials. Stent grafts appear to offer increased primary patency over balloon angioplasty in the treatment of dialysis circuit stenosis. However, there is generally no significant difference between the two treatment modalities on other clinically relevant measures like complication rates and overall survival.

Modern multidisciplinary team approach is crucial in treatment for critical limb threatening ischemia.

The aim of this study was to provide a brief overview of the history the multidisciplinary team approach, highlighting the benefit to the patient with critical limb threatening ischemia in relation to health care economics. Furthermore, we provided a description of the requisites and key components, showing how to build a multidisciplinary team.

Improving IR Ergonomics Using a Flexible C-Arm System.

PURPOSE: To evaluate the impact of a versatile flexible ceiling-mounted C-arm on active table and gantry repositioning during interventions and its effect on operator discomfort, system usability, and patient safety compared with a traditional ceiling-mounted system. MATERIALS AND METHODS: There were 100 IR procedures studied: 50 in a traditional IR system (standard group) and 50 with a novel multiaxis ceiling-mounted system (test group). FlexArm was capable of multiple gantry rotation points allowing increased access to the patient in addition to 236 cm of lateral x-ray detector travel. For each procedure, both the table and the gantry repositioning were measured. Patient safety, patient/equipment repositioning effort, and physical discomfort were evaluated through an operator survey. RESULTS: Table repositioning was reduced from 42 to 16 instances per procedure (P < .001) in the test group compared with the standard group. The operators perceived less table and gantry repositioning effort (P < .0001) and decreased risks of equipment collisions, displacement of vascular access, and dislodgment of tubes/lines with the test group (P < .0001). Operator discomfort was reduced for all body areas in the test group over the standard group (P < .0001). CONCLUSIONS: The FlexArm system geometry enhances operator ergonomics, as there was a decrease need to move the table, leading to a perceived decrease in patient risk and decrease operator physical discomfort when compared to a traditional imaging system.

Quality Assurance for Carotid Stenting in the CREST-2 Registry.

BACKGROUND: The CREST-2 Registry (C2R) was approved by National Institute of Neurological Disorders and Stroke-National Institutes of Health in September 2014 with Centers for Medicare & Medicaid Services, U.S. Food and Drug Administration, and industry collaboration to enroll patients undergoing CAS. The registry credentials interventionists and promotes optimal patient selection, procedural-technique, and outcomes. OBJECTIVES: This study reports periprocedural outcomes in a cohort of carotid artery stenting (CAS) performed for asymptomatic and symptomatic carotid stenosis. METHODS: Asymptomatic patients with ≥70% and symptomatic patients with ≥50% carotid stenosis, ≤80 years of age, and at standard or high risk for carotid endarterectomy are eligible for enrollment. Interventionists are credentialed by a multispecialty committee that reviews experience, lesion selection, technique, and outcomes. The primary endpoint was a composite of stroke and death (S/D) in the 30-day periprocedural period. Myocardial infarction and access-site complications were assessed as secondary outcomes. RESULTS: As of December 2018, 187 interventionists from 98 sites in the United States performed 2,219 CAS procedures in 2,141 patients with primary atherosclerosis (78 were bilateral). The mean age of the cohort was 68 years, 65% were male, and 92% were white; 1,180 (55%) were for asymptomatic disease, and 961 (45%) were for symptomatic disease. All U.S. Food and Drug Administration-approved stents and embolic protection devices were represented. The 30-day rate of S/D was 1.4% for asymptomatic, 2.8% for symptomatic, and 2.0% for all patients. CONCLUSIONS: C2R is the first national registry for CAS cosponsored by federal and industry partners. CAS was performed by experienced operators using appropriate patient selection and optimal technique. In that setting, a broad group of interventionists achieved very low periprocedural S/D rates for asymptomatic and symptomatic patients.

Snapshot of current carotid artery stenting practice and accreditation in the USA.

OBJECTIVE: The aim of this exploratory study was to compare the performance of carotid artery stenting (CAS) best practices between Intersocietal Accreditation Commission (IAC) accredited facilities and non-accredited facilities certified by the Centers for Medicare and Medicaid Services (CMS). METHODS: A random, anonymous survey was sent to CMS and IAC accredited facilities querying facility routine performance of 16 CAS procedure components found in published guidelines and utilised during clinical trials. RESULTS: There were 28 responses (response rate=17%). Significant differences were found between the CMS and the IAC facilities for four of 16 procedure measures: determination of modified Rankin Scale score prior to stenting (p=0.012, 95% CI 20% to 80%), accurate measurement of per cent stenosis using electronic callipers (p=0.005, 95% CI 24% to 84%), confirmation of anticoagulation with activated clotting time greater than 250 s prior to crossing the lesion (p=0.03, 95% CI 7% to 69%), and comparison of facility outcomes to accepted benchmarks for stroke and death (p=0.03, 95% CI 7% to 69%). Overall, IAC facilities performed all 16 procedures more frequently (97%) than CMS facilities (66%) (p<0.001, 95% CI 24% to 36%). CONCLUSIONS: Although the sample size was small, the results demonstrated IAC accredited facilities are more likely to follow best practices, to use quantitative tools to select appropriate patients, and quantitively measure patient-centred clinical outcomes compared with CMS certified facilities. The findings raise the question as to the value of CMS certification versus IAC accreditation as a requirement for reimbursement.

Propensity Score-Adjusted Comparison of Long-Term Outcomes Among Revascularization Strategies for Critical Limb Ischemia.

BACKGROUND: Few studies have compared long-term outcomes among specific treatment modalities for critical limb ischemia. The aim of this study was to compare long-term outcomes with percutaneous transluminal angioplasty (PTA), stent placement, atherectomy, or surgical bypass in patients diagnosed with critical limb ischemia. METHODS: In this observational study using Medicare claims data, we identified incident cases with a primary critical limb ischemia diagnosis who received PTA, stent placement, atherectomy, or surgical bypass. We used propensity score weighting to determine the association of treatment type with all-cause mortality and major (above ankle) amputation over 4 years follow-up. RESULTS: Among 36 860 patients (10 904 PTA; 11 295 stent placement; 4422 atherectomy; 10 239 surgical bypass), all-cause mortality over 4 years was 49.3% with atherectomy, 51.4% with surgical bypass, 53.7% with stent placement, and 54.7% with PTA (P<0.05 for all pairwise comparisons). Major amputation rates over 4 years were 6.8% with atherectomy, 7.8% with stent placement, 8.1% with PTA, and 10.8% with surgical bypass (P<0.05 for all pairwise comparison except PTA versus stent). CONCLUSIONS: Among Medicare beneficiaries who received PTA, stent placement, atherectomy, or surgical bypass for critical limb ischemia, high mortality and major amputation rates were observed with minor differences among treatment groups. Statistically significant group differences of uncertain clinical importance were observed for several comparisons. Results from observational research may be susceptible to bias because of unmeasured confounders and, therefore, these comparative results should be interpreted with caution.

Determinants of Long-Term Outcomes and Costs in the Management of Critical Limb Ischemia: A Population-Based Cohort Study.

Background The optimal treatment for critical limb ischemia remains controversial owing to conflicting conclusions from previous studies. Methods and Results We obtained administrative claims on Medicare beneficiaries with initial critical limb ischemia diagnosis in 2011. Clinical outcomes and healthcare costs over 4 years were estimated among all patients and by first treatment (endovascular revascularization, surgical revascularization, or major amputation) in unmatched and propensity-score-matched samples. Among 72 199 patients with initial primary critical limb ischemia diagnosis in 2011, survival was 46% (median survival, 3.5 years) and freedom from major amputation was 87%. Among 9942 propensity-score-matched patients (8% rest pain, 26% ulcer, and 66% gangrene), survival was 38% with endovascular revascularization (median survival, 2.7 years), 40% with surgical revascularization (median survival, 2.9 years), and 23% with major amputation (median survival, 1.3 years; P<0.001 for each revascularization procedure versus major amputation). Corresponding major amputation rates were 6.5%, 9.6%, and 10.6%, respectively ( P<0.001 for all pair-wise comparisons). The cost per patient year during follow-up was $49 700, $49 200, and $55 700, respectively ( P<0.001 for each revascularization procedure versus major amputation). Conclusions Long-term survival and cost in critical limb ischemia management is comparable between revascularization techniques, with lower major amputation rates following endovascular revascularization. Primary major amputation results in shorter survival, higher risk of subsequent major amputation, and higher healthcare costs versus revascularization. Results from this observational research may be susceptible to bias because of the influence of unmeasured confounders.

Transapical endovascular repair of iatrogenic type A aortic dissection.

Intraoperative iatrogenic type A aortic dissection is a rare but known complication of cardiac surgery, with an incidence of 0.06% to 0.23%. Results are frequently catastrophic. The endovascular approach has made advances as an alternative treatment for aortic disease. However, the apical approach for transcatheter thoracic endovascular aortic repair is not well known. We present a 5-year follow-up of a case of iatrogenic type A aortic dissection after minimally invasive mitral valve repair successfully resolved by medical stabilization and subsequent transapical thoracic endovascular aortic repair.

National Trends in Nonstatin Use and Expenditures Among the US Adult Population From 2002 to 2013: Insights From Medical Expenditure Panel Survey.

BACKGROUND: Evidence supporting nonstatin lipid-lowering therapy in atherosclerotic cardiovascular disease risk reduction is variable. We aim to examine nonstatin utilization and expenditures in the United States between 2002 and 2013. METHODS AND RESULTS: We used the Medical Expenditure Panel Survey database to estimate national trends in nonstatin use and cost (total and out-of-pocket, adjusted to 2013 US dollars using a gross domestic product deflator) among adults 40 years or older. Nonstatin users increased from 3 million (2.5%) in 2002-2003 (20.1 million prescriptions) to 8 million (5.6%) in 2012-2013 (45.8 million prescriptions). Among adults with atherosclerotic cardiovascular disease, nonstatin use increased from 7.5% in 2002-2003 to 13.9% in 2012-2013 after peaking at 20.3% in 2006-2007. In 2012-2013, 15.9% of high-intensity statin users also used nonstatins, versus 9.7% of low/moderate-intensity users and 3.6% of statin nonusers. Nonstatin use was significantly lower among women (odds ratio 0.80; 95% confidence interval 0.75-0.86), racial/ethnic minorities (odds ratio 0.41; 95% confidence interval 0.36-0.47), and the uninsured (odds ratio 0.47; 95% confidence interval 0.40-0.56). Total nonstatin expenditures increased from $1.7 billion (out-of-pocket cost, $0.7 billion) in 2002-2003 to $7.9 billion (out-of-pocket cost $1.6 billion) in 2012-2013, as per-user nonstatin expenditure increased from $550 to $992. Nonstatin expenditure as a proportion of all lipid-lowering therapy expenditure increased 4-fold from 8% to 32%. CONCLUSIONS: Between 2002 and 2013, nonstatin use increased by 124%, resulting in a 364% increase in nonstatin-associated expenditures.

Asymptomatic carotid stenosis: Medicine alone or combined with carotid revascularization.

Two positive randomized trials established carotid endarterectomy (CEA) as a superior treatment to medical management alone for the treatment of asymptomatic carotid artery stenosis. However, advances in medical therapy have led to an active and spirited debate about the best treatment for asymptomatic carotid stenosis. The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis (CREST 2) trial aims to better define the best treatment for the average patient with severe asymptomatic carotid stenosis. Enrollment in the trial may be hampered by strong opinions on either side of the debate. It is important to realize that equipoise exists and that neither the old data on CEA nor the new data on optimal medical therapy provide a rigorous answer. The assumption that medical therapy has already been proven superior to revascularization procedures may hinder both enrollment in the trial and technical advancements in revascularization procedures.

The Effect of a New Angiographic Imaging Technology on Radiation Dose in Visceral Embolization Procedures.

PURPOSE: To evaluate the impact of a new angiographic imaging technology on radiation dose during visceral embolization procedures involving both fluoroscopy and digital subtraction angiography. MATERIAL AND METHODS: A retrospective analysis from a single-center consecutive series of patients was performed comparing 2 angiographic imaging systems. The AlluraClarity (CIQ; Philips Healthcare, Best, the Netherlands) was used in 100 patients (n = 59 male, mean age: 70.6 years) from July 2013 to April 2014 and compared to the former AlluraXper (AX) technology used in 139 patients (n = 71 male, mean age: 70.1 years) from May 2011 to June 2013. Patients were categorized according to body mass index (BMI [kg/m2])-group 1: BMI <25, group 2: BMI ≥25 and <30, and group 3: BMI ≥30. Fluoroscopy time, the total dose of iodinated contrast administered, and procedural AirKerma (Ka, r [mGy]) were obtained. RESULTS: Mean BMI was 26.4 ± 5.0 kg/m2 in the CIQ and 26.4 ± 7.1 kg/m2 in the AX group ( P = .93). Fluoroscopy time and the amount of contrast media were equally distributed. Ka, r was 1342.9 mGy versus 2214.8 mGy ( P < .001, t test) when comparing CIQ to AX. Comparing CIQ to AX, BMI subgroup analysis revealed a mean Ka, r of 970.1 to 1586.1 mGy ( P = .003, t test), 1484.7 to 2170.1 mGy ( P = .02, t test), and 1848.8 to 3348.9 mGy ( P = .001, t test) in BMI groups 1, 2, and 3, respectively. CONCLUSION: The CIQ technology significantly reduced mean radiation dose by 39.4% for visceral embolization procedures when compared to fluoroscopy time and contrast media dose. This dose relationship was consistent across all BMI groups.

Effect of ß-blocker on aneurysm sac behavior after endovascular abdominal aortic repair.

OBJECTIVE: This study was conducted to determine whether ß-blocker (BB) therapy is associated with abdominal aortic aneurysm (AAA) sac regression after endovascular abdominal aortic repair (EVAR). METHODS: A total of 198 patients (mean age, 76 years) who underwent EVAR were analyzed (104 in the BB group and 94 in the non-BB group). The primary end point was the incidence of AAA sac regression at 1 and 2 years. RESULTS: Hypertension, coronary artery disease, and hyperlipidemia were more common in the BB group. The BB group was also more likely to have been prescribed an aspirin and a statin than the non-BB group. The length of proximal neck was significantly longer in the non-BB group than in the BB group. All study patients were monitored for at least 1 year after EVAR, and 2-year follow-up was available in 104 patients (52.5%). There was no statistically significant difference in the incidence of aneurysm sac regression in either group at 1 year (52.1% in the non-BB group vs 45.2% in the BB group; P = .330) and 2 years (58.5% in the non-BB group vs 64.7% in the BB group; P = .515). The difference of the change of AAA maximum diameter between two groups did not reach statistical significance at 1 year (-6.0 ± 7.0 mm in the non-BB group vs -5.5 ± 8.1 mm in the BB group; P = .644) and 2 years (-9.0 ± 10.5 mm in the non-BB group vs -9.0 ± 10.0 mm in the BB group; P = .977). BB therapy was not associated with increased odds of AAA sac regression. The effect of third-generation BBs on AAA sac regression was not significant. CONCLUSIONS: BB therapy had no effect on AAA sac regression. At the present time, there is insufficient evidence to recommend BB therapy for the purpose of AAA sac regression.

Influence of Statin Therapy on Aneurysm Sac Regression after Endovascular Aortic Repair.

PURPOSE: To determine whether statin therapy is associated with abdominal aortic aneurysm (AAA) sac regression after endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: A total of 109 patients treated with EVAR were retrospectively analyzed (no-statin group, n = 45; statin group, n = 64). The primary endpoint was the incidence of AAA sac regression. To investigate independent predictors of AAA sac regression, regression analysis was performed. The mean age was 74 years (range, 55-90 y), and 87.2% of patients were men. RESULTS: The no-statin group had higher rates of AAA sac regression than the statin group at 1 year (no-statin group, 66.7%; statin group, 45.3%; P = .028). The incidence of AAA sac regression increased over time in the statin group, and no statistical difference was seen between the two groups at 2 years (no-statin group, 66.7%; statin group, 57.8%; P = .350). The difference between the changes in maximum AAA diameter was significant between groups at 1 year (no-statin group vs statin group, -4.9 mm ± 5.9; P = .041), but the difference did not reach statistical significance at 2 years (no-statin group, -10.0 mm ± 10.1; statin group, -8.0 mm ± 9.6; P = .306). Statin therapy was not associated with AAA sac regression on univariate (odds ratio [OR], 0.685; 95% confidence interval [CI], 0.310-1.516; P = .351) and multivariate analyses (OR, 0.617; 95% CI, 0.215-1.772; P = .369). CONCLUSIONS: Statin therapy had no effect on AAA sac regression at 2 years. There is insufficient evidence to recommend statin therapy for AAA sac regression.

Effects of Percutaneous Transluminal Angioplasty on Diastolic Function in Patients With Chronic Occlusion of Lower-Extremity Artery.

OBJECTIVE: We investigated whether successful revascularization of total occlusion of a large lower-extremity artery is associated with improvement of left ventricular (LV) diastolic function. BACKGROUND: Total occlusion of a large lower-extremity artery might affect the systemic vascular resistance and increase the afterload, because the left ventricle must work harder to eject blood into a smaller vascular bed. Chronic elevation of afterload is a cause of LV diastolic dysfunction. METHODS: This is a single-center retrospective analysis of 20 patients (10 men, age 69.6 ± 12.3 years) with chronic total occlusions (CTOs) of the aorto-iliac and femoropopliteal segments who underwent a successful endovascular revascularization. Baseline and postprocedural evaluation of diastolic function was performed, and the primary endpoint was improvement in LV diastolic function, which was defined as any decrease of the baseline E/E' ratio or any increase of the baseline E' velocity after the index procedure. RESULTS: There was a significant effect of successful revascularization on the E/A ratio (from 1.5 ± 1.1 to 1.0 ± 0.3; P=.046) because of a significant increase of A velocity (from 86.3 ± 30.4 cm/s to 98.3 ± 21.8 cm/s; P=.03). The E' velocity (from 7.4 ± 2.0 cm/s to 8.3 ± 2.3 cm/s; P=.07) did not show a significant increase, but there was a significant reduction in E/E' ratio (from 14.6 ± 3.9 to 12.4 ± 3.3; P=.02). Logistic regression analysis did not identify possible predictors of improvement in LV diastolic function. CONCLUSION: Our results showed that a successful revascularization was associated with improvement in the echocardiographic parameters of LV diastolic function in patients with CTO of large lower-extremity artery, and these changes may be related to the afterload reduction.

The Influence of Statin Therapy on Restenosis in Patients Who Underwent Nitinol Stent Implantation for de Novo Femoropopliteal Artery Disease: Two-Year Follow-up at a Single Center.

PURPOSE: To determine whether statin therapy is associated with reduced restenosis following nitinol stent implantation for de novo femoropopliteal artery disease. MATERIALS AND METHODS: A total of 135 limbs in 135 patients (mean age, 72 y) implanted with nitinol stents in femoropopliteal occlusions were analyzed (statin arm, n = 91; nonstatin arm, n = 44). The patients were treated with one type of nitinol stent. RESULTS: At baseline, lesions and procedural characteristics were comparable between groups, except that the statin group had more hypertension, coronary artery disease, and hyperlipidemia. There were significant differences in the incidence of binary restenosis between groups at 1 year (45.5% for nonstatin group vs 28.6% for statin group; P = .05) and 2 years (56.8% for nonstatin group vs 38.5% for statin group; P = .04). Primary patency rates at 1 year were 50.5% in the nonstatin group and 72.5% in the statin group (P = .01). Two-year target lesion revascularization rates were 54.5% in the nonstatin group and 35.2% in the statin group (P = .03). On univariate analysis, statin therapy was associated with decreased relative risk of binary restenosis at 1 year (odds ratio [OR], 0.480; 95% confidence interval [CI], 0.227-1.014; P = .050). On multivariate analysis, statin therapy did not significantly affect the odds of binary restenosis (OR, 0.415; 95% CI, 0.071-2.437; P = .330). CONCLUSIONS: The incidence of binary restenosis was significantly lower in the statin group than in the nonstatin group following nitinol stent implantation for de novo femoropopliteal artery disease.