Drug-eluting balloons for the treatment of the superficial femoral artery in-stent restenosis: 2-year follow-up.

OBJECTIVES: The aim of this prospective registry was to evaluate the safety and efficacy at 2-year follow-up of the use of drug-eluting balloons (DEBs) for the treatment of superficial femoral artery (SFA) in-stent restenosis (ISR). BACKGROUND: The use of DEBs for the treatment of SFA ISR is associated with a satisfactory primary patency rate at 1 year, but no data are available for longer follow-up. Unfortunately, when DEBs were used to treat SFA de novo lesions, the occurrence of restenosis increased by 50% between the first and the second years of follow-up. METHODS: From December 2009 to December 2010, 39 consecutive patients underwent percutaneous transluminal angioplasty of SFA ISR at our institution (Clinica Montevergine, Mercogliano, Italy). All patients underwent conventional SFA percutaneous transluminal angioplasty and final post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic Inc., Minneapolis, Minnesota). Patients were evaluated for up to 24 months. RESULTS: During follow-up, 1 patient died of heart failure and another of sudden death, for a 2-years rate of cardiovascular mortality rate of 5.12 %. The primary patency rate at 2 years was 70.3% (11 of 37 patients experienced restenosis recurrence at 2-year follow-up). The treatment of complex ISR lesions (classes II and III) was associated with an increased rate of recurrent restenosis compared with class I (33.3 % and 36.3 % vs. 12.5%; p = 0.05). CONCLUSIONS: The data suggest that adjunctive use of DEBs for the treatment of SFA ISR is a safe and effective therapeutic strategy up to 2 years of follow-up

Magna Graecia transcatheter aortic valve implantation registry: data on contrast medium osmolality and postprocedural acute kidney injury

A comprehensive description of baseline characteristics, procedural features and outcomes related to the development of acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is reported in our research paper (Impact of contrast medium osmolality on the risk of acute kidney injury after transcatheter aortic valve implantation: insights from the Magna Graecia TAVI registry. Int J Cardiol. DOI: 10.1016/j.ijcard.2020.12.049). Three Italian heart centers were involved in this multicentric observational study. Between March 2011 and February 2019, a total of 888 patients underwent TAVI; according to the inclusion and exclusion criteria, 697 patients were included in the post-hoc analysis. This Data in Brief paper aims to report demographic, clinical, laboratory, echocardiographic, intraprocedural, periprocedural, postprocedural and follow-up data; all of them were prospectively collected from each patient's health record, whereas the analysis was performed retrospectively. Targets of this data analysis were: 1) to evaluate the impact of contrast medium (CM) osmolality on TAVI-related AKI; 2) to identify the most of risk factors involved in the development of such complication, and consequently in the occurrence of 1-year mortality; 3) to estimate the impact of CM osmolality on AKI in specific patient subgroups

Impact of contrast medium osmolality on the risk of acute kidney injury after transcatheter aortic valve implantation: insights from the Magna Graecia TAVI registry

Background: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is frequent and associated with adverse outcomes and mortality; to date, in such setting of patients there is no consistent evidence that either low-osmolar contrast media (LOCM) or iso‐osmolar contrast medium (IOCM) are superior to the other in terms of renal safety. Methods: 697 consecutive patients not in hemodialysis treatment who underwent TAVI (327 males, mean age 81.01 ± 5.75 years, mean european system for cardiac operative risk evaluation II 6.17 ± 0.23%) were enrolled. According to osmolality of the different iodinated CM, the population was divided in 2 groups: IOCM (n = 370) and LOCM group (n = 327). Preoperatively, 40.54% of patients in IOCM vs 39.14% in LOCM group (p = 0.765) suffered from chronic kidney disease (CKD). Results: The incidence of AKI was significantly lower with IOCM (9.73%) than with LOCM (15.90%; p = 0.02), and such significant difference (p < 0.001) in postprocedural change of renal function parameters persisted at discharge too. The incidence of AKI was also significantly lower with IOCM in younger patients, without diabetes, anemia, coronary artery disease history, CKD, chronic or persistent atrial fibrillation, left ventricular ejection fraction ≤35%, and in patients with low operative mortality risk scores, receiving lower amounts of dye (p < 0.05 for all). Importantly, multivariate analysis identified LOCM administration as an independent risk factor for both AKI (p = 0.006) and 1-year mortality (p = 0.001). Conclusions: The use of IOCM have a favorable impact on renal function with respect to LOCM, but it should be considered especially for TAVI patients at lower AKI risk

Predictors of carotid occlusion intolerance?during proximal protected?carotid artery?stenting.

OBJECTIVES: The aim of this study was to identify predictors of occlusion intolerance (OI) developing during proximal protected carotid artery stenting (CAS). BACKGROUND: The use of proximal embolic protection devices, such as endovascular occlusion, during CAS has been demonstrated to be particularly safe and effective. However, endovascular occlusion can expose the ipsilateral hemisphere to hypoperfusion and produce transient neurological symptoms (OI). METHODS: From March 2010 to March 2012, 605 consecutive patients underwent proximal protected CAS at our institution. To identify independent predictors of OI, a multivariate logistic regression model was developed that included all patients' clinical/angiographic and procedural characteristics. RESULTS: OI developed in a total of 184 patients (30.4%). Compared with patients in whom OI did not develop, those who experienced OI had lower occlusion pressure (OP) (42.3 ± 12.7 mm Hg vs. 61.9 ± 15.4 mm Hg, p < 0.001). Receiver-operating characteristic curve analysis demonstrated that OP was the most consistent predictor of OI with a C-statistic of 0.85 (95% confidence interval [CI]: 0.82 to 0.88) with best cutoff being ≤40 mm Hg (sensitivity, 68.5%; specificity, 93.3%). By logistic regression analysis, the most powerful independent predictor of OI developing was an OP ≤40 mm Hg (odds ratio: 33.2, 95% CI: 19.1 to 57.7) and the most powerful clinical predictor of such OP was the presence of contralateral internal carotid artery occlusion (odds ratio: 3.1, 95% CI: 1.5 to 6.2). CONCLUSIONS: OI may occur in as many as one-third of the patients undergoing proximal protected CAS. This event is more common in those patients with an OP ≤40 mm Hg. Patients presenting with concomitant occlusion of the contralateral internal carotid artery more frequently have an OP ≤40 mm Hg

Double layered stents for carotid angioplasty: a meta-analysis of available clinical data

OBJECTIVES: The objective of this meta-analysis is to evaluate clinical efficacy of double layered mesh covered carotid stent systems in the clinical practice. BACKGROUND: The need for an increase plaque coverage to decrease the risk of debris dislodgement through the stent struts, following carotid artery stenting (CAS), has brought to the design of a new generation of double layered carotid stents. Several small sized clinical studies evaluating two different devices have been recently published, unfortunately these are not sufficiently powered to test for device related and clinical endpoints and no comparison, between the two available devices, has been reported yet. METHODS: Ten studies, enrolling 635 patients, were included in the present meta-analysis. Our study analyzed a composite endpoint of 30-day stroke and death and the occurrence of procedural unsuccess after CAS with the use of two different double layered carotid stent systems. RESULTS: Thirty-day stroke and death rate was quite low (patients 635, event rate 0.02, 95% CI: 0.01-0.04, P < 0.0001). The incidence of procedural unsuccess with these devices was relatively low (patients 635, event rate 0.03, 95% CI: 0.01-0.08, P < 0.0001). When a subgroup analysis was performed, according to the specific subtype of carotid stent, no differences in the occurrence of 30-day death and stroke rate and procedural unsuccess were observed (P = 0.979). CONCLUSIONS: This meta-analysis suggests that dual layered carotid stents could be safely used for the treatment of extracranial carotid artery stenosis, with a relatively low rate of procedural unsuccess, and allow achieving a quite low rate of postprocedural adverse events