30 research outputs found

    Cardiovascular Risk Reduction After Renal Denervation According to Time in Therapeutic Systolic Blood Pressure Range

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    Background: Renal denervation (RDN) has been shown to lower blood pressure (BP), but its effects on cardiovascular events have only been preliminarily evaluated. Time in therapeutic range (TTR) of BP is associated with cardiovascular events. Objectives: This study sought to assess the impact of catheter-based RDN on TTR and its association with cardiovascular outcomes in the GSR (Global SYMPLICITY Registry). Methods: Patients with uncontrolled hypertension were enrolled and treated with radiofrequency RDN. Office and ambulatory systolic blood pressure (OSBP and ASBP) were measured at 3, 6, 12, 24, and 36 months postprocedure and used to derive TTR. TTR through 6 months was assessed as a predictor of cardiovascular events from 6 to 36 months using a Cox proportional hazard regression model. Results: As of March 1, 2022, 3,077 patients were enrolled: 42.2% were female; mean age was 60.5 ± 12.2 years; baseline OSBP was 165.6 ± 24.8 mm Hg; and baseline ASBP was 154.3 ± 18.7 mm Hg. Patients were prescribed 4.9 ± 1.7 antihypertensive medications at baseline and 4.8 ± 1.9 at 36 months. At 36 months, mean changes were −16.7 ± 28.4 and −9.0 ± 20.2 mm Hg for OSBP and ASBP, respectively. TTR through 6 months was 30.6%. A 10% increase in TTR after RDN through 6 months was associated with significant risk reductions from 6 to 36 months of 15% for major adverse cardiovascular events (P < 0.001), 11% cardiovascular death (P = 0.010), 15% myocardial infarction (P = 0.023), and 23% stroke (P < 0.001). Conclusions: There were sustained BP reductions and higher TTR through 36 months after RDN. A 10% increase in TTR through 6 months was associated with significant risk reductions in major cardiovascular events from 6 to 36 months. (Global SYMPLICITY Registry [GSR] DEFINE; NCT01534299

    Bleeding complications at the access sites during catheter directed thrombolysis for acute limb ischaemia: Mini review

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    Acute and subacute ischemia of the lower limbs represents a major emergency with a high in-hospital mortality, complication, and leg amputation rates. Treatment options for acute limb ischemia include systemic anticoagulation, followed by various catheter based options including infusion of fibrinolytic agents (pharmacological thrombolysis), pharmacomechanical thrombolysis, catheter-mediated thrombus aspiration, mechanical thrombectomy, and any combination of the above or open surgical intervention (thromboembolectomy or surgical bypass). Minor and major bleeding complication during catheter directed thrombolysis (CDT) especially at access site are frequent. Bleeding complications require often an interruption or termination of CDT affecting clinical outcome of the patients. Recently we examined a new access site bleeding protection device during CDT

    Evaluation of Stent Angioplasty in the Treatment of Arteriosclerotic Lesions of the Common Femoral Artery

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    In many vascular segments, endovascular therapy is the treatment of choice for arteriosclerotic lesions. For the treatment of common femoral artery (CFA) lesions, surgical reconstruction is still considered the gold standard. The purpose of this study is to evaluate the safety and efficacy of stent angioplasty for the treatment of common femoral artery (CFA) lesions in a real-world population during a two-year follow up. This retrospective, single-center study includes 250 patients requiring treatment with stent angioplasty of CFA lesions. The primary end point was the target lesion revascularization (TLR) rate. Secondary end points were the overall procedural complication rate, the rate of ipsilateral CFA punctures during follow-up, changes in the Rutherford–Becker class (RBC) and ankle–brachial index (ABI), primary patency rates, amputation rate, time to and the type of TLR. A total of 236 interventions (94.4%) were successfully defined as a residual stenosis < 30%. Periinterventionally, there were 23 complications (9.1%), 3 of which had to be treated surgically. Median follow up was 21 months (average 19.2 ± 7.8). In total, 41 patients (16.4%) needed a TLR. The primary patency rate was 90.8%, 81.2% and 72% at 6, 12 and 24 months, respectively. ABI and RBC were significantly better at all time points compared to baseline. During follow up, seven amputations (three minor and four major) had to be performed. More than half of the patients (56.0%) were punctured at the stented CFA during the follow up. Multivariate logistic regression analysis showed continued nicotine use and coronary heart disease as predictors for TLR. Stent angioplasty for the treatment of CFA lesions is safe and effective. Further studies are needed to compare this endovascular option with surgical therapy

    Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions : the Viabahn-25 cm trial

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    Purpose: To confirm the performance and safety of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface when used in the treatment of de novo and/or restenotic TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral artery and proximal popliteal artery. Methods: The 25-cm Gore Viabahn Endoprosthesis study (ClinicalTrials.gov identifier NCT01263665) is a prospective, multicenter, single-arm study that enrolled 71 patients (50 men; mean age 66.7 +/- 8.34 years) with lifestyle-limiting claudication (Rutherford class 2 to 4) and lesions longer than 20 cm (mean length 26.5 +/- 5.31 cm, range 20-40). The majority of lesions (92.9%) were total occlusions. The primary performance outcome was post-deployment stent length within 610% of the pre-deployment stent length determined angiographically by quantitative vascular analysis. The primary safety outcome was device- and procedure-related serious adverse events occurring within 30 days of the procedure. The patients underwent follow-up examinations at 1 month and 1 year. Results: The median follow-up was 12.3 months (mean 12.3 +/- 0.6). Nine (12.7%) patients discontinued the study due to different reasons including 2 bypass surgeries. Angiography was available in 60 patients to determine the primary performance outcome, which was met in all cases. Two (2.8%) patients experienced a procedure-/ device-related adverse event (dissection) during the 30-day follow-up. Kaplan-Meier estimates for 1-year primary and secondary patency were 67.0% [95% confidence interval (CI) 53.5% to 77.3%] and 96.9% (95% CI 88.0% to 99.2%), respectively. Changes in ankle-brachial index and Rutherford category at 1 and 12 months each showed sustained improvement. Conclusion: This study confirms that the 25-cm Viabahn endoprosthesis acutely performs as intended and is safe when used as indicated in complex femoropopliteal lesions. Oneyear primary and secondary patency rates are satisfying and comparable to historical prosthetic bypass graft outcomes

    Percutaneous retrieval of intravascular and intracardiac foreign bodies with a dedicated three-dimensional snare: a 3-year single center experience

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    INTRODUCTION: The presence of symptomatic or asymptomatic intravascular/intracardiac foreign body (FB) is under-reported in the literature, but it is more commonly encountered in clinical practice. The implantation of long-term venous catheters and the number of technical challenging endovascular procedures are both constantly increasing. Thus, the number of reported FBs will also increase, becoming a serious concern, especially once associated with a cardiovascular complication. MATERIALS AND METHODS: We report the analysis of 22 patients in whom an intravascular/cardiac FBs retrieval was attempted. The details of the procedure have been discussed in depth emphasizing the technical aspects of the utilized dedicated three-dimensional snare device (Entrio snare). The technical feasibility, safety, and efficacy of the retrieval procedure were then analyzed. RESULTS: We divided our patients into two groups. Group 1 included 12 patients in whom the FB had already migrated in the right heart or in the pulmonary circulation. Group 2 included 10 patients with an intravascular FB (intravenous or intraarterial). Technical retrieval success rate was 95.5% (21/22), with a 35-min procedural mean time and no in-hospital procedural-related complications. CONCLUSIONS: Our data confirm that different kinds of FBs lodging in different sites of the cardiovascular system can safely and efficaciously be percutaneously retrieved by utilizing a dedicated three-dimensional snare device. This, therefore, suggests that this minimally invasive intervention should be rapidly attempted, thus anticipating several serious complications
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