Characteristics, Antithrombotic Patterns, and Prognostic Outcomes in Claudication and Critical Limb-Threatening Ischemia Undergoing Endovascular Therapy.

PURPOSE: The underlying difference between intermittent claudication (IC) and critical limb-threatening ischemia (CLTI) still remains unclear. This prospective multicenter observational study aimed to clarify differences in clinical features and prognostic outcomes between IC and CLTI, and prognostic factors in patients undergoing endovascular therapy (EVT). MATERIALS AND METHODS: A total of 692 patients with 808 limbs were enrolled from 20 institutions in Japan. The primary measurements were the 3-year rates of major adverse cardiovascular event (MACE) and reintervention. RESULTS: Among patients, 79.0% had IC and 21.0% had CLTI. Patients with CLTI were more frequently women and more likely to have impaired functional status, undernutrition, comorbidities, hypercoagulation, hyperinflammation, distal artery disease, short single antiplatelet and long anticoagulation therapies, and late cilostazol than patients with IC. Aortoiliac and femoropopliteal diseases were dominant in patients with IC and infrapopliteal disease was dominant in patients with CLTI. Patients with CLTI underwent less frequently aortoiliac intervention and more frequently infrapopliteal intervention than patients with IC. Longitudinal change of ankle-brachial index (ABI) exhibited different patterns between IC and CLTI (pinteraction=0.002), but ABI improved after EVT both in IC and in CLTI (p<0.001), which was sustained over time. Dorsal and plantar skin perfusion pressure in CLTI showed a similar improvement pattern (pinteraction=0.181). Distribution of Rutherford category improved both in IC and in CLTI (each p<0.001). Three-year MACE rates were 20.4% and 42.3% and 3-year reintervention rates were 22.1% and 46.8% for patients with IC and CLTI, respectively (log-rank p<0.001). Elevated D-dimer (p=0.001), age (p=0.043), impaired functional status (p=0.018), and end-stage renal disease (p=0.019) were independently associated with MACE. After considering competing risks of death and major amputation for reintervention, elevated erythrocyte sedimentation rate (p=0.003) and infrainguinal intervention (p=0.002) were independently associated with reintervention. Patients with CLTI merely showed borderline significance for MACE (adjusted hazard ratio 1.700, 95% confidence interval 0.950-3.042, p=0.074) and reintervention (adjusted hazard ratio 1.976, 95% confidence interval 0.999-3.909, p=0.05). CONCLUSIONS: The CLTI is characterized not only by more systemic comorbidities and distal disease but also by more inflammatory coagulation disorder compared with IC. Also, CLTI has approximately twice MACE and reintervention rates than IC, and the underlying inflammatory coagulation disorder per se is associated with these outcomes. CLINICAL IMPACT: The underlying difference between intermittent claudication (IC) and critical limb-threatening ischemia (CLTI) still remains unclear. This prospective multicenter observational study, JPASSION study found that CLTI was characterized not only by more systemic comorbidities and distal disease but also by more inflammatory coagulation disorder compared to IC. Also, CLTI had approximately twice major adverse cardiovascular event (MACE) and reintervention rates than IC. Intriguingly, the underlying inflammatory coagulation disorder per se was independently associated with MACE and reintervention. Further studies to clarify the role of anticoagulation and anti-inflammatory therapies will contribute to the development of post-interventional therapeutics in the context of peripheral artery disease.

Clinical outcomes of transcatheter aortic valve implantation (TAVI) in nonagenarians from the optimized catheter valvular intervention-TAVI registry.

OBJECTIVES: The purpose of this study was to investigate 30-day and 2-year clinical outcomes, and predictors of 2-year mortality in nonagenarians undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: TAVI has been applied to nonagenarians. However, sufficient clinical data in nonagenarians who could benefit from TAVI are limited. METHODS: We evaluated the data from the optimized catheter valvular intervention-TAVI registry. Clinical outcomes were compared between patients' age ≥90 years and age <90 years. Predictive factors of 2-year mortality were assessed by multivariable Cox regression analyses. RESULTS: From October 2013 to May 2017, a total of 375 nonagenarians (age ≥90 years) and 2,213 younger patients (age <90 years) were included. Although nonagenarians had a higher surgical risk score, 30-day clinical outcomes were similar between two groups. There were no significant differences in 2-year mortality (22.0% vs. 17.3%; p = .11) and stroke (5.5% vs. 3.9%; p = .31); however, 2-year heart failure readmission was higher in nonagenarians (13.3% vs. 9.0%; p = .03). After adjusting covariates, age ≥90 years was not independent predictor for 2-year outcomes. In nonagenarians, female sex (hazard ratio [HR] = 0.43; 95% confidence interval [CI] = 0.26-0.74; p = .002), chronic kidney disease grade ≥4 (HR = 2.14; 95% CI = 1.21-3.64; p = .01), and Clinical Frailty Scale ≥4 (HR = 1.82; 95% CI = 1.02-3.42; p = .04) were independently associated with 2-year mortality. CONCLUSIONS: Clinical outcomes of TAVI in selected nonagenarians were favorable. Severe renal dysfunction and frailty may be important factors to predict mid-term mortality after TAVI in nonagenarians.

Midterm outcomes after the rescue THV-in-THV procedure: Insights from the multicenter prospective OCEAN-TAVI registry.

OBJECTIVES: To confirm whether the rescue transcatheter heart valve in the transcatheter heart valve (THV-in-THV) procedure is effective and feasible, we aimed to assess the midterm outcomes following rescue THV-in-THV procedures. The trends in the usage of the rescue THV-in-THV procedure at the time of transcatheter aortic valve implantation (TAVI) have also been explored. BACKGROUND: Midterm outcomes of the rescue THV-in-THV procedure have been poorly defined, though it is popular as an effective method to bail-out some complications in TAVI. METHODS: We reviewed data from the Optimized transCathEter vAlvular iNtervention-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry and compared the outcomes of TAVI with rescue THV-in-THV and TAVI without rescue THV-in-THV. We also examined the annual rates of rescue THV-in-THV procedures in all the TAVI procedures between 2013 and 2017. RESULTS: Among 2,588 patients who underwent TAVI, 26 patients have required rescue THV-in-THV for valve malposition (n = 23) or severe transvalvular regurgitation because of stuck THV leaflets (n = 3). Three cases needed an open conversion, and two died in the hospital. The rates of new permanent pacemaker implantation, acute kidney injury, and stroke were higher in the THV-in-THV group. A two-year cumulative survival and echocardiographic outcomes succeeding rescue THV-in-THV procedure were comparable to non-THV-in-THV cases. The rate of rescue THV-in-THV procedure lessened from 2.6% in 2013 to 0.6% in 2017. CONCLUSIONS: The rescue THV-in-THV procedure is an effective and feasible option for THV malpositioning and stuck valve. It has given a comparable survival and a stable valve function over midterm observation periods.

Clinical risk model for predicting 1-year mortality after transcatheter aortic valve replacement.

OBJECTIVES: Estimating 1-year life expectancy is an essential factor when evaluating appropriate indicators for transcatheter aortic valve replacement (TAVR). BACKGROUND: It is clinically useful in developing a reliable risk model for predicting 1-year mortality after TAVR. METHODS: We evaluated 2,588 patients who underwent TAVR using data from the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese multicenter registry from October 2013 to May 2017. The 1-year clinical follow-up was achieved by 99.5% of the entire population (n = 2,575). Patients were randomly divided into two cohorts: the derivation cohort (n = 1,931, 75% of the study population) and the validation cohort (n = 644). Considerable clinical variables including individual patient's comorbidities and frailty markers were used for predicting 1-year mortality following TAVR. RESULTS: In the derivation cohort, a multivariate logistic regression analysis demonstrated that sex, body mass index, Clinical Frailty Scale, atrial fibrillation, peripheral artery disease, prior cardiac surgery, serum albumin, renal function as estimated glomerular filtration rate, and presence of pulmonary disease were independent predictors of 1-year mortality after TAVR. Using these variables, a risk prediction model was constructed to estimate the 1-year risk of mortality after TAVR. In the validation cohort, the risk prediction model revealed high discrimination ability and acceptable calibration with area under the curve of 0.763 (95% confidence interval, 0.728-0.795, p < .001) in the receiver operating characteristics curve analysis and a Hosmer-Lemeshow χ2 statistic of 5.96 (p = .65). CONCLUSIONS: This risk prediction model for 1-year mortality may be a reliable tool for risk stratification and identification of adequate candidates in patients undergoing TAVR.

Update on the clinical impact of mild aortic regurgitation after transcatheter aortic valve implantation: Insights from the Japanese multicenter OCEAN-TAVI registry.

OBJECTIVES: This study aimed to compare the clinical impact of mild postprocedural aortic regurgitation (post-AR) to that of none-trivial post-AR after transcatheter aortic valve implantation (TAVI) and to identify the vulnerability factors to mild post-AR. BACKGROUND: Moderate-severe post-AR, associated with increased mortality, is an important issue. However, the clinical impact of mild post-AR remains controversial. METHODS AND RESULTS: We analyzed data from 1,572 consecutive patients (1,026 of none-trivial post-AR and 546 of mild post-AR) obtained from the Optimized transCathEter vAlvular Intervention (OCEAN-TAVI) Japanese multicenter registry. We evaluated the 1-year cumulative cardiovascular death and re-hospitalization rates for heart failure (HF) after TAVI according to the degree of post-AR. Kaplan-Meier curves showed no significant difference between "none-trivial post-AR" and "mild post-AR" in terms of cardiovascular death, but a significant difference was noted in the cumulative incidence of re-hospitalization for HF between the two groups (hazard ratio 1.57, 95% confidence interval 1.02-2.41, p = .04). In the stratified analysis, only in patients with not more than 50% of left ventricular ejection fraction (LVEF), concentric left ventricular hypertrophy (LVH), and none-trivial pre-procedural aortic regurgitation (pre-AR), mild post-AR resulted in a higher incidence of re-hospitalization for HF. CONCLUSIONS: In this study, the clinical impact of mild post-AR compared to none-trivial post-AR tended to be augmented in the presence of reduced LVEF, concentric LVH, and none-trivial pre-AR. Pre-procedure echocardiographic findings including LVEF, left ventricular geometry, and pre-AR may help to judge the necessity of postdilatation in case of mild post-AR just after the bioprosthesis deployment.

Prognostic impact and periprocedural complications of chronic steroid therapy in patients following transcatheter aortic valve replacement: Propensity-matched analysis from the Japanese OCEAN registry.

OBJECTIVE: This study aimed to assess the effect of chronic steroid use on periprocedural complications and clinical outcomes after transcatheter aortic valve replacement (TAVR). BACKGROUND: Chronic steroid use increases the risk of periprocedural complications and mortality during surgery. METHODS: We investigated 1,313 consecutive patients with aortic stenosis who underwent transfemoral (TF)-TAVR using data from a Japanese multicenter registry. The baseline characteristics, periprocedural complications including vascular complications (VCs), access route related VCs, and clinical outcomes were compared between patients in the steroid group and nonsteroid group. RESULTS: Major VCs and access route VCs occurred more in the steroid group than in the nonsteroid group (13.4 vs. 5.8%, p = .019; 20.9% vs. 9.8%, p = .004). Especially in the surgical cut-down group, the rate of access route VCs was differed between the two groups (28.0% vs. 7.5%, p = .003). The 30-day mortality rates were similar between the two groups (0% vs. 1.4%, p = .39). In the propensity score-matched model, the higher incidence of major VCs in the steroid group was maintained, although early mortality was similar in the two groups. CONCLUSIONS: Although chronic steroid therapy is not associated with increased early mortality, chronic steroid use may affect periprocedural VCs and access route VCs mainly due to surgical cut-down in patients following TF-TAVR.

Utility of indigo carmine angiography in patients with critical limb ischemia: Prospective multi-center intervention study (DIESEL-study).

OBJECTIVES: To assess the efficacy of indigo carmine angiography for wound healing after successful below-the-knee intervention in patients with critical limb ischemia (CLI). METHODS: A multi-center prospective intervention study was conducted. Fifty-four limbs of 53 patients in Rutherford categories 5 and 6 underwent endovascular therapy (EVT). After successful EVT, 5 mL of indigo carmine was injected through a catheter at the distal popliteal artery and color changes in the foot were evaluated. The results of indigo carmine angiography were divided into three groups: In type I, the color change of the wound was deeper than the surrounding tissue; in type II, the change in wound color was similar to the surrounding tissue; and in type III, no discoloration of the wound was observed by the indigo carmine. RESULTS: The wound healing rates at 3 months were 78% (25/32) for type I, 70% (7/10) for type II, and 42% (5/12) for type III (P for trend = 0.025). Indigo carmine angiography-related complications were not seen. CONCLUSION: Indigo carmine angiography was found to be a safe and useful procedure to provide visual information on foot perfusion. This dye coloring method demonstrated that after successful angioplasty, the perfused area was made visible at the microcirculation level. Indigo carmine angiography can thus be considered an important predictor for wound healing by EVT in patients with CLI.

Association between valvuloarterial impedance after transcatheter aortic valve implantation and 2-year mortality in elderly patients with severe symptomatic aortic stenosis: the OCEAN-TAVI registry.

Pre-procedural valvuloarterial impedance (Zva) is considered as a useful predictor of mortality in patients diagnosed as having severe aortic stenosis (AS) who undergo transcatheter aortic valve implantation (TAVI). However, the prognostic significance of post-procedural Zva remains unclear. We aimed to evaluate the prognostic significance of Zva after TAVI. We retrospectively analyzed the clinical and echocardiographic data of 1004 consecutive elderly patients (median 84 years old, 27.5% men) who underwent TAVI for severe symptomatic AS. Zva was calculated after TAVI, and patients were divided into three groups based on tertile values: the high [> 3.33 (n = 335)], intermediate [2.49-3.33 (n = 334)], and low Zva groups [< 2.49 (n = 335)]. The estimated 2-year all-cause and cardiovascular mortalities using Kaplan-Meier analysis were 16.2% [95% confidence interval (CI) 11.8-20.4] and 5.9% (95% CI 3.2-8.6), respectively. There were no significant intergroup differences in each endpoint (long-rank p = 0.518 for all-cause mortality, p = 0.757 for cardiovascular mortality). Multivariable Cox regression analyzes with adjustments of patient characteristics and medications showed that the post-procedural Zva was not associated with the 2-year all-cause mortality [intermediate Zva group versus (vs.) low Zva group: adjusted hazard ratio (aHR) = 1.34, 95% CI 0.75-2.40, p = 0.316; high Zva group vs. low Zva group: aHR = 1.17, 95% CI 0.64-2.16, p = 0.613] and cardiovascular mortality (intermediate Zva group vs. low Zva group: aHR = 1.50, 95% CI 0.56-4.06, p = 0.421; high Zva group vs. low Zva group: aHR = 1.25, 95% CI 0.43-3.65, p = 0.682). Our results suggest that post-procedural Zva was not associated with 2-year all-cause or cardiovascular mortalities in patients with severe symptomatic AS who underwent TAVI.

The MAGGIC risk score predicts mortality in patients undergoing transcatheter aortic valve replacement: sub-analysis of the OCEAN-TAVI registry.

This study is aimed to evaluate the performance of MAGGIC risk score for predicting mortality by external validation using multicenter transcatheter aortic valve replacement (TAVR) registry. We assessed 1383 patients who underwent TAVR from October 2013 to April 2016. Patients were divided into 2 groups according to the median of MAGGIC score and we compared the incidence of all-cause death between high and low MAGGIC score. To assess whether the MAGGIC risk score add prognostic value on STS risk score, we also compared the incidence of all-cause death between the 2 groups according to low, intermediate, and high STS score. The median of MAGGIC score was 29 (interquartile range: 13-46). Within 2 years, 147 cases of all-cause death were observed. The high MAGGIC (30-46) risk score was significantly associated with an increased risk of all-cause death as compared to low MAGGIC (11-29) risk score and this relationship was also observed in patients with high STS risk score. However, this relationship was not observed in patients with low and intermediate STS score. Multivariate analysis showed that the MAGGIC risk score was an independent predictor of all-cause death (hazard ratio, 1.07; 95% confidence interval, 1.03-1.11). Our results demonstrated that the MAGGIC score predicts all-cause death in TAVR population and provides better risk stratification, particularly in patients with high STS risk.

Importance of Geriatric Nutritional Risk Index assessment in patients undergoing transcatheter aortic valve replacement.

BACKGROUND: Nutritional condition is one marker of patients' frailty. The Geriatric Nutritional Risk Index (GNRI) is a well-known marker of nutritional status. This study sought to assess the clinical outcomes of GNRI after transcatheter aortic valve replacement (TAVR). METHODS: We evaluated the GNRI value of 1,613 patients who underwent TAVR using data from a Japanese multicenter registry. According to baseline GNRI, patients were classified into 3 groups: GNRI ≥92 (n = 1,085; 67.3%), GNRI 82-92 (n = 396; 24.6%), and GNRI ≤82 (n = 132; 8.2%). Baseline characteristics, procedural outcomes, and cumulative mortality rates were compared. In addition, GNRI correlations with other frailty components (gait speed, grip strength, and Clinical Frailty Scale) and Society of Thoracic Surgeons (STS) score were also evaluated. RESULTS: Significantly increased mortality rates were observed across the 3 groups at 30 days (0.9%, 2.3%, and 6.8%, respectively; P < .001) and 1 year (6.5%, 16.4%, and 36.4%, respectively; P < .001). Both GNRI 82-92 and GNRI ≤82 (as a reference for GNRI ≥92) were independently associated with increased midterm mortality in the Cox regression multivariate model (hazard ratio: 1.97, 3.60; 95% confidence interval: 1.37-2.84, 2.30-5.64; P < .001, P < .001, respectively). The GNRI value was significantly correlated with gait speed (Spearman ρ = -0.15, P < .001), grip strength (ρ = 0.25, P < .001), Clinical Frailty Scale (ρ = -0.24, P < .001), and STS score (ρ = -0.29, P < .001). CONCLUSIONS: GNRI is related to both frailty components and the STS score and is an important surrogate marker for predicting worse clinical outcomes after TAVR. Assessment of the GNRI may be considered when deciding on TAVR.

Risk stratification using lean body mass in patients undergoing transcatheter aortic valve replacement.

BACKGROUND: The prognostic impact of skeletal muscle mass, assessed using lean body mass (LBM), remain unclear in patients who underwent transcatheter aortic valve replacement (TAVR). The aim of this study to assess prognostic impact of LBM on mortality after TAVR. METHODS: We assessed 1,613 patients (median age 85 years, 70% female) who underwent TAVI from October 2013 to April 2016 using OCEAN (Optimized transCathEter vAlvular interveNtion)-TAVI registry data. LBM was calculated using the James formula. The primary endpoint was all-cause death after TAVR. RESULTS: Median follow-up period was 287 days (interquartile range 110-462). The Kaplan-Meier analysis demonstrated that patients with low LBM had significantly higher incidence of all-cause death than those with high LBM in male (32.3% vs. 9.9%, log rank P < 0.001) and female (15.8% vs. 9.2%, log-rank P = 0.011). On contrary, the risk stratification using body mass index (BMI) could not validate into female patients who underwent TAVR. The multivariate analysis showed that the LBM was an independent predictor of all-cause death in male (Hazard ratio [HR] 0.93; 95% confidence interval [CI] 0.89-0.98) and female (HR 0.94; 95% CI 0.89-0.99). Inversely, the assessment using BMI could not identify the high-risk population in a female. CONCLUSIONS: The patients with low LBM had the higher incidence of all-cause death after TAVR than those with high LBM, regardless of gender. Thus, the risk stratification using LBM might provide further insight to identify the high-risk TAVR population, compared to conventional risk stratification using BMI.

Ankle-brachial pressure index as a predictor of the 2-year outcome after transcatheter aortic valve replacement: data from the Japanese OCEAN-TAVI Registry.

Peripheral artery disease plays a pivotal role for access site selection in transcatheter aortic valve replacement (TAVR). Abnormal ankle-brachial index (ABI) is a generalized mortality marker in many cardiovascular scenarios. However, the long-term outcomes in high-risk TAVR populations remain unclear. We investigated the association between low ABI and 2-year outcome after TAVR. Of 1613 patients enrolled in the OCEAN-TAVI registry, 1458 (90.4%) who underwent ABI before TAVR were divided into groups: patients with (1) ABI ≥ 0.9 in both legs and (2) ABI < 0.9 in either leg. Primary endpoint was all-cause death within 2 years. ABI < 0.9 was noted in 304 patients (20.8%). ABI < 0.9-group had more frequent and severe comorbidities. Primary endpoint in ABI < 0.9-group was significantly higher than that in ABI ≥ 0.9-group (15.8 vs. 8.7%, p < 0.001). This trend continued in the transfemoral (TF)-approach (14.9 vs. 7.5%, p < 0.001), but not in the alternative approach (17.2 vs. 15.8%, p = 0.815). Within 30 days, ABI < 0.9-group had a higher cardiac death rate (3.1 vs. 1.0%, p = 0.033), whereas between 31 days and 2 years, non-cardiovascular death was more frequently observed (9.2 vs. 5.1%, p = 0.003). In ABI < 0.9-group, in-hospital vascular complications (11.9 vs. 4.9%, p < 0.001) and acute kidney injury (10.8 vs, 5.7%, p = 0.009) were more frequently found when using the transfemoral-approach. In multivariate analysis, ABI < 0.9 was an independent predictor of 2-year mortality (adjusted hazard ratio 1.495, 95% CI 1.007-2.220, p = 0.046). Pre-procedure ABI < 0.9 is a useful prognostic marker for all-cause mortality, even in high-risk TAVR populations.

Comparison of midterm outcomes of transcatheter aortic valve implantation in patients with and without previous coronary artery bypass grafting.

The midterm safety and feasibility of transcatheter aortic valve implantation (TAVI) for patients with a history of coronary artery bypass graft (CABG) and high operative risk are unclear. This study compared the midterm outcomes of patients undergoing TAVI with or without previous CABG surgery. Between October 2013 and July 2016, 1,613 patients underwent TAVI according to the Optimized CathEter vAlvular iNtervention (OCEAN)-TAVI registry (previous CABG: n = 120; no previous CABG: n = 1493). The propensity score comprised the variables of the Society of Thoracic Surgeons Score, previous myocardial infarction, peripheral artery disease, chronic kidney disease > stage 2 (estimated glomerular filtration rate < 60 mL/min/1.73 m2), and the TAVI approach method. After propensity matching, 118 patients were classified into the CABG and non-CABG groups. Kaplan-Meier analysis revealed that the incidence of overall cardiovascular death in the CABG group was significantly higher than in the non-CABG group (log-rank; p = 0.004). Overall mortality due to heart failure was higher in the CABG than in the non-CABG group (8.5 vs. 1.7%, p = 0.038). The present study demonstrated that patients with a history of CABG who underwent TAVI had a higher frequency of cardiovascular death, mainly due to heart failure. Heart failure detection and rigorous heart failure management are required after TAVI.

Outcomes of One straight-line flow with and without pedal arch in patients with critical limb ischemia.

OBJECTIVES: This study aimed to compare the outcomes of revascularization strategies for patients with critical limb ischemia (CLI) whereby single vessel run off to the foot was established with or without flow into a patent pedal arch. METHODS: We retrospectively analyzed data from 312 consecutive patients with CLI who underwent endovascular therapy (EVT) between December 2009 and February 2011. Below-the-knee angiography identified one vessel run off in 137 patients (44%), and we aimed to compare the outcomes between those patients where revascularization resulted in one-straight-line flow into a patent pedal arch (76 limbs, Group A) versus those who attained one straight-line flow to the distal end of a tibial vessel without flow into a patent pedal arch (61 limbs, Group B). The study endpoints were amputation free survival rate, limb salvage rate and wound healing rate at 12 months after EVT. RESULTS: Amputation free survival rate differed significantly between groups (88.2% in group A vs. 65.6% in group B, P = 0.01). Limb salvage rate also differed between groups (98.4% vs.89.3%, P = 0.03). Wound healing rate showed a trend towards difference between the two groups (89.4% vs. 80.6% P = 0.11). CONCLUSIONS: Among patients with CLI where only one vessel runoff can be established to the foot, direct flow into a patent pedal arch is essential to improve their clinical outcomes. © 2015 Wiley Periodicals, Inc.

Outcomes of Zilver PTX stent implantation for the treatment of complex femoropopliteal artery disease.

The purpose of this study was to evaluate the efficacy of Zilver PTX, the first drug-eluting stent, in patients with complex femoropopliteal (FP) artery disease. Between July 2012 and March 2013, 60 consecutive patients (39 males; mean age: 72.5 ± 8.6 years) with complex risk factors including TASC II C/D lesions, in-stent restenosis (ISR) and/or on haemodialysis underwent successful Zilver PTX implantation for symptomatic FP artery disease. The primary outcome was primary patency, which was defined as freedom from restenosis at 12 months, as verified by duplex ultrasound. Secondary outcomes included the technical success rate, the freedom from target lesion revascularisation (TLR) rate and the amputation-free survival (AFS) rate. The average follow-up period was 13.2 ± 5.3 months. 62 % of the patients had TASC II C/D lesions, 35.0 % experienced ISR, and 41.6 % were on haemodialysis. The mean lesion length was 188 ± 96 mm. The technical success rate was 98.3 %. The primary patency rate was 50.2 %, the freedom from clinically driven TLR rate was 68.6 %, and the AFS rate was 83.2 % at 12 months. In conclusion, Zilver PTX stent implantation for complex FP artery disease did not affect long-term durability.

Nitinol stent implantation for femoropopliteal disease in patients on hemodialysis: results of the 3-year retrospective multicenter APOLLON study.

The clinical outcomes of nitinol stents for femoropopliteal arterial (FP) disease in patients on hemodialysis were assessed. Endovascular therapy (EVT) is accepted for symptomatic FP disease. However, the clinical outcomes of patients on dialysis are not well known. A multicenter retrospective study was conducted with data between November 2010 and August 2013. A total of 484 consecutive patients who successfully underwent EVT for FP disease with nitinol stents were recruited and analyzed. Patients were categorized into the hemodialysis group (N = 161) and non-hemodialysis group (N = 323). The primary measure was primary patency verified by duplex ultrasound at a rest peak systolic velocity (PSVR) of >2.5, and secondary measures were freedom from target lesion revascularization (TLR) and major amputation-free survival (AFS). Average follow-up duration was 19.5 ± 13.5 months. The primary patency rate at 3 years was significantly lower in the hemodialysis group than the non-hemodialysis group (33.8 vs. 43.7 %; p = 0.036). Freedom from TLR at 3 years was 55.0 % in the hemodialysis group and 66.1 % in the non-hemodialysis group (p = 0.032). The hemodialysis group showed a significantly lower AFS rate at 3 years than the non-hemodialysis group (86.4 vs. 58.2 %; p < 0.001). In hemodialysis patients, nitinol stent use resulted in a lower patency rate, higher TLR rate, and lower AFS rate compared to non-hemodialysis patients. These data suggest that nitinol stent implantation for FP arteries in hemodialysis patient needs to be reconsidered.

Intravascular Ultrasound-Guided Mesenteric Stenting in Patients with Advanced Chronic Kidney Disease.

Endovascular treatment of chronic mesenteric ischemia in patients with impaired renal function or allergy to contrast media is a challenging procedure because angiography requires iodinated contrast media for accurate diagnosis and interventional procedures. Superior mesenteric artery stenting without contrast angiography is described in an 81-year-old woman with cardiovascular disease and chronic kidney disease (CKD) stage 5. Balloon angioplasty and stent placement were performed successfully using intravascular ultrasound, pressure wire, surface ultrasound, and fluoroscopy. Intervention without contrast media has wide applicability to patients with advanced CKD and/or those with allergy to iodinated contrast media.

Endovascular therapy by CO2 angiography to prevent contrast-induced nephropathy in patients with chronic kidney disease: a prospective multicenter trial of CO2 angiography registry.

OBJECTIVES: To assess the safety and efficacy of carbon dioxide (CO2) angiography-guided endovascular therapy (EVT) for renal, iliofemoral artery disease. BACKGROUND: Patients with peripheral vascular disease (PVD) often have chronic kidney disease (CKD) and the use of iodinated contrast media may enhance the risk of contrast-induced nephropathy (CIN). Contrast volume reduction is an effective CIN preventive strategy. METHODS: A prospective multicenter registry was developed and six clinical centers participated in the study. Patients with an estimated glomerular filtration rate (eGFR) of <60 ml/min/1.73 m2 and stage-3 CKD were recruited between February 2012 and March 2013. CO2 angiography-guided EVT was performed; incomplete CO2 angiograms were supplemented by intravascular ultrasound, pressure wire, and/or minimal iodinated contrast media. The primary endpoint was a composite of freedom from renal events and freedom from major CO2 angiography related complications. RESULTS: This study included 98 patients with 109 lesions. The mean eGFR baseline was 35.2±12.7 ml min(-1). CO2 angiography-guided angioplasty were performed in 16 renal arteries, 31 aortoiliac arteries, and 62 superficial femoral arteries. The technical success rate was 97.9%. Average CO2 consumption was 281.4±155.8 ml, average dose of iodinated contrast media was 15.0±18.1 ml. Primary endpoint was 92.8% (91/98). Incidence of CIN was 5.1% (5/98) and CO2 angiography-related complications occurred in 17.3% (17/98). Two cases (2%) developed severe, fatal, nonocclusive mesenteric ischemia (NOMI). CONCLUSIONS: This trial showed that CO2 angiography-guided angioplasty was effective for preventing CIN, however, CO2 angiography related complication was somewhat high.

Use of indigo carmine angiography to qualitatively assess adequate distal perfusion after endovascular revascularization in critical limb ischemia.

PURPOSE: To report a novel technique to visualize the efficacy of revascularization in critical limb ischemia patients with ischemic foot ulcers. TECHNIQUE: An 80-year-old man was admitted with nonhealing ulcers on his left second toe and lateral border of the foot owing to in-stent restenosis of the left popliteal artery. After dilation of the popliteal in-stent restenosis, below-the-knee angiography revealed that the anterior tibial artery (ATA) was occluded, the posterior tibial artery was hypoplastic, and the peroneal artery was enlarged, with 2 plantar arteries. To evaluate the foot circulation before performing additional procedures, a 4-F multipurpose catheter was advanced into the peroneal artery, and 5 mL of indigo carmine was injected. Immediately, the patient's second toe and lateral border ulcers were dyed blue. We concluded that sufficient blood flow had been obtained to the ulcerated area by balloon angioplasty alone, so the procedure was terminated. The ulcers completely healed at 1 month. CONCLUSION: Indigo carmine angiography provides visual information on foot perfusion, yielding new insights into microcirculation and helping to determine the effectiveness of treatment and procedure endpoint.

Long-term results of primary stenting for subclavian artery disease.

OBJECTIVES: To evaluate initial and long-term results of endovascular therapy (EVT) for symptomatic subclavian artery (SCA) disease. BACKGROUND: EVT for SCA disease has a similar success rate as open surgery, but the long-term patency of EVT alone is uncertain. METHODS: We retrospectively studied 59 consecutive patients (42 males and 17 females) with 60 lesions. Mean patient age was 68 ± 10 years. Clinical symptoms were vertebrobasilar insufficiency in 21 patients (35.0%), arm claudication in 20 patients (33.3%), angina pectoris in 12 patients (20%), severe arm ischemia in 3 patients (5.0%), vascular access insufficiency in 3 patients (5.0%), and leg ischemia in 1 patient (1.7%). A total of 57 stents were implanted. All patients were followed up at 1, 3, 6, and 12 months after the procedure and annually thereafter. RESULTS: The technical success rate was 93.3%. All patients for whom technical success was obtained received stents. There were four technical failures, all of which were owing to the failure of crossing the wire in occluded lesions. There were no procedure-related deaths. There were two stroke events (3.4%) and one embolic event (1.7%). Primary patency rates were 94.9, 90.8, and 85.8% at 1, 3, and 5 years, respectively. CONCLUSIONS: EVT for SCA disease is an effective treatment with regard to initial success rate, clinical efficacy, and long-term primary patency. This minimally invasive procedure is appropriate as the treatment of first choice for proximal subclavian arterial obstructive disease.