Purpose: To investigate the angiographic dissection patterns after balloon angioplasty for superficial femoral artery (SFA) lesions, the clinical outcome associated with each dissection pattern, and ...the predictive factors for severe dissection. Methods: A retrospective, multicenter analysis examined 621 patients (mean age 72.8±9.5 years; 414 men) with 748 symptomatic de novo SFA lesions treated with endovascular therapy. Vessel dissection after the initial balloon angioplasty procedure was graded into 7 types according to a modified version of the coronary artery classification types A to F. Severe vessel dissection patterns were defined as type C or higher. Nitinol stent implantation was performed in 555 (74.2%) lesions for residual stenosis >30% or flow-limiting dissection; 193 lesions (25.8%) were treated with balloon angioplasty only. To determine the clinical outcomes associated with each dissection pattern and identify predictive factors for severe dissection, 2-year follow-up data for the 193 lesions treated with balloon angioplasty only were analyzed for primary patency and clinically driven target lesion revascularization (TLR). Results: No dissection was found in 16% (120/748) of lesions, and types A and B dissections were seen in 19% (142/748) and 23% (172/748), respectively. Dissection grades above type C were observed in 42% of cases, most frequently type D (180/748, 24%) and less often type C (37/748, 5%), type E (67/748, 9%), and type F (30/748, 4%). The bailout stent implantation rate increased according to dissection severity. At up to 2 years, the severe dissection group (types C–F) showed a significantly lower patency rate (p<0.001) and higher clinically driven TLR (p<0.001) compared to the nonsevere group (no dissection and types A and B dissections). Severe dissection was a significant risk factor for restenosis, which rose progressively from types C to F. Multivariate analysis identified a small reference vessel diameter <5 mm (p=0.001), lesion length >15 cm (p=0.001), and chronic total occlusion (p<0.001) as independent predictors of severe dissection. In subgroup analysis, vessels with a small reference diameter and TASC II C and D lesions had a higher prevalence of severe dissection. Conclusion: Severe dissection was found in 42% of cases after PTA. A small vessel diameter and/or TASC II C/D lesions were related to a high incidence of dissection. Severe dissection during procedures employing balloon angioplasty only could affect long-term patency.
Most cases of femoral–popliteal disease require aggressive medical treatment, but patients with severe lifestyle-limiting symptoms and limb-threatening disease are increasingly receiving endovascular ...treatment. The femoropopliteal artery is the longest vessel in the thigh and the unique physical forces involved in this vessel are considered to cause high rates of restenosis and stent fracture. Endovascular therapy for superficial artery (SFA) disease is still a challenge in terms of long-term patency and clinical effectiveness. The purpose of this brief review is to reexamine previously published key trials in order to identify and compare the differences of each study. Discussion of how to interpret the results of these studies is vital for the incorporation of the data into actual real-life cases.
Background: Because of revisions to insurance reimbursement costs, medical fees have changed for investigations and percutaneous coronary intervention (PCI) treatment of chronic coronary syndrome ...(CCS). In this retrospective study, we investigated these changes and their effects on mortality and cardiovascular events.Methods and Results: We included 1,483 patients who underwent elective PCI for CCS between April 2010 and September 2019. The primary outcomes were changes in PCI procedure fees and all included hospitalization fees due to the biennial revisions of reimbursement costs across 5 time periods (~2 years each). Secondary outcomes were rates of survival and freedom from major adverse cerebral and cardiovascular events (MACCE) in each time period. Patient characteristics were generally unchanged over the study period; however, treatment procedures changed significantly, with changes in the approach site (from transfemoral to transradial access; P<0.0001) and final device (from bare-metal stents to drug-eluting stents; P<0.0001), and an increase in the use of imaging modalities (P<0.0001). Medical fee parameters (primary outcomes) decreased significantly from 2010 to 2019 (P<0.001): PCI procedure fees decreased by 25%, whereas all included hospitalization fees decreased by 20%. There were no significant differences in survival or freedom-from-MACCE rates between periods.Conclusions: Because of revisions to reimbursement prices, there were rapid and significant decreases in PCI procedure and hospitalization fees for CCS. These changes had no effect on mortality or cardiovascular events.
Purpose: To assess calcium patterns in superficial femoral artery (SFA) disease before and after balloon angioplasty ± stent implantation using fluoroscopy, angiography, and intravascular ultrasound ...(IVUS) imaging and then correlate calcification severity and midterm clinical outcomes. Materials and Methods: A multicenter investigation was carried out to retrospectively review 130 symptomatic patients (mean age 73.2±8.4 years; 86 men) with de novo SFA lesions who had successfully undergone endovascular therapy (EVT) at 7 centers between January and October 2015. The primary outcome was lumen gain measured as minimum lumen area (MLA) in post-EVT IVUS images according to calcification severity. The secondary outcomes included rates of stent malapposition, restenosis, and clinically-driven target lesion revascularization (TLR). Results: A total of 102 (78.5%) cases had calcification in the lesions over a mean length of 64.3±72.8 mm. Of these, 70 cases were classified as having bilateral calcification according to fluoroscopy and angiography; 50 (49%) lesions had ≥180° calcification according to IVUS. The lumen gain in calcified lesions was significantly smaller than in the 28 noncalcified lesions (14.1±4.4 vs 17.8±5.2 mm2, p<0.001). IVUS-evaluated circumferential distribution of calcium (<180° or ≥180°) was independently associated with lumen gain after EVT (p<0.001). Among the calcification characteristics, a calcification angle ≥180° showed the strongest correlation to postprocedure MLA. Moreover, the restenosis rate was significantly higher in the severe (≥180°) calcification group (p<0.018). The severity of calcification was also associated with the risk of stent malapposition (p=0.022 for trend) but not TLR (p=0.57). Conclusion: IVUS evaluation of calcification in SFA lesions predicted lumen gain after EVT. Severe calcification in a ≥180° arc prevented successful dilation of the lesion with either plain balloon angioplasty or a nitinol stent. Accurate assessment of calcification patterns by IVUS is useful in maximizing the efficacy of endovascular therapy.
Renal denervation is a promising new non-pharmacological treatment for resistant hypertension. However, there is a lack of data from Asian patients. The REQUIRE trial investigated the blood ...pressure-lowering efficacy of renal denervation in treated patients with resistant hypertension from Japan and South Korea. Adults with resistant hypertension (seated office blood pressure ≥150/90 mmHg and 24-hour ambulatory systolic blood pressure ≥140 mmHg) with suitable renal artery anatomy were randomized to ultrasound renal denervation or a sham procedure. The primary endpoint was change from baseline in 24-hour ambulatory systolic blood pressure at 3 months. A total of 143 patients were included (72 renal denervation, 71 sham control). Reduction from baseline in 24-hour ambulatory systolic blood pressure at 3 months was not significantly different between the renal denervation (-6.6 mmHg) and sham control (-6.5 mmHg) groups (difference: -0.1, 95% confidence interval -5.5, 5.3; p = 0.971). Reductions from baseline in home and office systolic blood pressure (differences: -1.8 mmHg p = 0.488 and -2.0 mmHg p = 0.511, respectively), and medication load, did not differ significantly between the two groups. The procedure-/device-related major adverse events was not seen. This study did not show a significant difference in ambulatory blood pressure reductions between renal denervation and a sham procedure in treated patients with resistant hypertension. Although blood pressure reduction after renal denervation was similar to other sham-controlled studies, the sham group in this study showed much greater reduction. This unexpected blood pressure reduction in the sham control group highlights study design issues that will be addressed in a new trial. CLINICAL TRIAL REGISTRATION: NCT02918305 ( http://www.clinicaltrials.gov ).
It remains unclear whether cilostazol, which has been shown to improve the clinical outcomes of endovascular therapy for femoropopliteal lesions, also reduces angiographic restenosis.
The Sufficient ...Treatment of Peripheral Intervention by Cilostazol (STOP-IC) study investigated whether cilostazol reduces the 12-month angiographic restenosis rate after percutaneous transluminal angioplasty with provisional nitinol stenting for femoropopliteal lesions. Two hundred patients with femoropopliteal lesions treated from March 2009 to April 2011 at 13 cardiovascular centers were randomly assigned 1:1 to receive oral aspirin with or without cilostazol. The primary end point was 12-month angiographic restenosis rate. Secondary end points were the restenosis rate on duplex ultrasound, the rate of major adverse cardiac events, and target lesion event-free survival. Researchers evaluated all follow-up data and assessed the end points in a blinded fashion. The mean lesion length and reference vessel diameter at the treated segment were 128±86 mm and 5.4±1.4 mm, respectively. The frequency of stent used was similar between groups (88% versus 90% in the cilostazol and noncilostazol group, respectively, P=0.82). During the 12-month follow-up period, 11 patients died and 152 patients (80%) had evaluable angiographic data at 12 months. The angiographic restenosis rate at 12 months was 20% (15/75) in the cilostazol group versus 49% (38/77) in the noncilostazol group (P=0.0001) by intention-to-treat analysis. The cilostazol group also had a significantly higher event-free survival at 12 months (83% versus 71%, P=0.02), although cardiovascular event rates were similar in both groups.
Cilostazol reduced angiographic restenosis after percutaneous transluminal angioplasty with provisional nitinol stenting for femoropopliteal lesions.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00912756; and URL: https://www.umin.ac.jp. Unique identifier: UMIN000002091.
Background:
Endovascular therapy for acute lower limb ischemia (ALLI) has developed and demonstrated safety and efficacy. The purpose of this study was to assess clinical outcomes in patients treated ...for ALLI with conventional endovascular or surgical revascularization.
Method:
This study was a retrospective single-center review. Consecutive patients with ALLI treated with conventional endovascular revascularization (ER) without thrombolytic agent or surgical revascularization (SR) between 2008 and 2014 were investigated. The 1 year and 3 year amputation rate and mortality rate were assessed by time-to-event methods, including Kaplan–Meier estimation.
Result:
A total of 64 limbs in 62 patients with ALLI due to thromboembolism or thrombosis of a native artery, bypass graft, or previous stented vessel were included. The majority of limbs (90.9%) presented with Rutherford clinical categories 1 to 2 ischemia. Technical success rate was 95.5% in ER and 92.9% in SR group (p = 0.547). Overall amputation rates were 9.1% in ER versus 9.5% in SR after 1 year (p = 0.971) and 9.1% in ER versus 11.9% in SR after 3 year (p = 0.742). Overall mortality rates were 15% in ER versus 7.1% in SR after 1 year (p = 0.491) and 15% in ER versus 11.2% in SR after 3 year (p = 0.878).
Conclusion:
Endovascular or surgical revascularization of ALLI resulted in comparable outcomes in limb salvage and mortality rate at 1 year and 3 year. Conventional endovascular therapy without thrombolytic agent such as stenting, balloon angioplasty, or catheter-directed thrombosuction may be considered as a treatment option for ALLI.
For more than 10 years, the Harmonization by Doing (HBD) program, a joint effort by members from academia, industry and regulators from the United States of America (USA) and Japan, has been working ...to increase timely regulatory approval for cardiovascular devices through the development of practical global clinical trial paradigms. Consistent with this mission and in recognition of the increasing global public health effects of critical limb ischemia (CLI), academic and government experts from the USA and Japan have developed a basic framework of global clinical trials for endovascular devices for CLI. Despite differences in medical and regulatory environments and complex patient populations in both countries, we developed a pathway for the effective design and conduct of global CLI device studies by utilizing common study design elements such as patients’ characteristics and study endpoints, and minimizing the effect of important clinical differences. Some of the key recommendations for conducting global CLI device studies are: including patients on dialysis; using a composite primary endpoint for effectiveness that includes 6-month post-procedure therapeutic success and target vessel patency; and using a 30-day primary safety endpoint of perioperative death and major adverse limb events. The proposed approach will be uniquely beneficial in facilitating both the initiation and interpretation of CLI studies and accelerating worldwide CLI device development and innovation.
Aim: Although current guidelines recommend surgical revascularization as the first-line therapy for chronic total occlusion of the abdominal aorta (Leriche syndrome), endovascular therapy (EVT) has ...been increasingly utilized because of the development of new technologies and techniques. EVT has demonstrated durable midterm outcomes for aortoiliac occlusive disease (AIOD). Nonetheless, little is known regarding their long-term outcomes and predictors of restenosis.Methods: We retrospectively analyzed a multicenter database of 64 consecutive patients (age, 73±10 years; 64% male; 22% critical limb ischemia) undergoing EVT for aortoiliac occlusive disease between September 2005 and March 2016. The outcome measures were primary and secondary patency, following EVT, calculated using the Kaplan–Meier method. Independent predictors associated with restenosis were assessed using Cox proportional hazard regression model.Results: Technical success was achieved in 61 patients (95%). In total, 214 stents (192 self-expandable stents, 22 balloon-expandable stents) were implanted. During the follow-up of 33±28 months, 11 patients experienced loss of patency. The primary patency rates were 88%, 70%, and 70% at 1, 3, and 5 years, respectively. The secondary patency rates were 98%, 87%, and 77% at 1, 3, and 5 years, respectively. In Cox regression analysis, E-Luminexx stent use (in 29 patients, 48%) was associated with restenosis hazard ratio, 4.41, P=0.038.Conclusion: In this retrospective study, EVT for AIOD demonstrated favorable 5-year patency. E-Luminexx stent implantation was associated with restenosis in this population.
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