Three-year outcome of directional atherectomy and drug coated balloon for the treatment of common femoral artery steno-occlusive lesions.

BACKGROUND: Endarterectomy is considered the gold standard therapy for common femoral artery (CFA) steno-occlusive lesions, but a significant risk of perioperative mortality and complications has been reported. OBJECTIVE: Aim of this study is to evaluate the efficacy at a long-term follow-up of patients with CFA steno-occlusive lesions treated with directional atherectomy and drug coated balloon (DCB). MATERIAL AND METHODS: In this single-center registry, 78 patients (male: 80.7%; age: 71 ± 15 years; occlusions: 25%) with 80 CFA lesions were included, with 39.7% of them undergoing directional atherectomy and drug coated balloon due to critical limb ischemia and 60.3% due to lower-limb intermittent claudication. The long-term follow-up was completed by 75 patients (3 years). The 31 patients with critical ischemia (39.7%) were further subdivided into 20 (25.6%) patients with pain at rest and 11 (14.1%) with trophic changes, ulcers and/or tissue loss. We considered the primary and the secondary outcome, referring, respectively to peak systolic velocity ratio (PSVR) ≥ 2.4 on duplex or > 50% stenosis on digital subtraction angiography at 36 months and to clinically driven target lesion revascularization at 36 months. RESULTS: The primary and secondary outcome was obtained in 84% and 86.7% of patients, at 36 months of follow up. Bailout stenting was necessary in 6/80 cases (7.5%) for suboptimal result. Freedom from MALE was obtained in 98.6% of patients. CONCLUSIONS: These results confirm that directional atherectomy and drug coated balloon strategy for the treatment of CFA lesions is effective at a long-term follow-up and could be considered as a good alternative to surgery.

Conduction delays after transcatheter aortic valve implantation with balloon-expandable prosthesis and high implantation technique.

Performing transcatheter aortic valve implantation with high implantation technique, i.e. with an aorto-ventricular ratio > 60/40, reduces the need of permanent pacemaker implantation. Valve calcification and prosthesis oversizing are predictors of permanent pacemaker implantation, but there are no available data on their role when transcatheter aortic valve implantation is performed with an aorto-ventricular ratio > 60/40. The aim of this study was to evaluate the effect of leaflets/annulus calcification and prosthesis oversizing on the incidence of permanent pacemaker implantation after transcatheter aortic valve implantation with a high implantation technique. Transcatheter aortic valve implantation was performed in 48 patients implanting a balloon-expandable transcatheter heart valve with an aorto-ventricular ratio > 60/40. Calcium burden was assessed by preprocedural multidetector computed tomography. An invasive electrophysiological study was performed before and after transcatheter aortic valve implantation. Five patients (10.4%) needed permanent pacemaker implantation. At univariate analysis, baseline right bundle branch block and postprocedural PR, QRS and His-ventricular interval elongation significantly predicted permanent pacemaker implantation (p < 0.05). Receiver-operating characteristic curve analysis showed a correlation between transcatheter heart valve oversizing and permanent pacemaker implantation need, with the best cut-off being 17% (AUC = 0.72, p = 0.033). Linear regression analysis demonstrated that QRS complex elongation was related to total, left and non-coronary leaflet calcification (p < 0.05). This study demonstrates that, when transcatheter aortic valve implantation is performed using a balloon-expandable transcatheter heart valve deployed with an aorto-ventricular ratio > 60/40, the presence of leaflets/annulus calcification or the need to oversize the prosthesis correlate with the occurrence of pathological cardiac conduction delays.

One-Year Clinical Outcomes of the Legflow Drug-Coated Balloon for the Treatment of Femoropopliteal Occlusions Registry.

PURPOSE: To report the 1-year outcomes of the prospective Legflow drug-coated balloon (DCB) registry, which evaluated the safety and 12-month efficacy of the Legflow balloon in the treatment of femoropopliteal disease. METHODS: The Legflow is a new generation of DCB that has a homogenous, stable surface coating incorporating 0.1-µm paclitaxel particles. From January 2014 to June 2016, 139 patients (mean age 67.1±10.8 years; 109 men) were enrolled at 4 European institutions. Seventy-nine (56.8%) patients had claudication, while 60 (43.2%) had critical limb ischemia (CLI). Mean lesion length (MLL) was 90.0±41.2 mm. Eighty (57.6%) patients were treated for de novo lesions (MLL 83.2±41.2 mm), 29 (20.9%) for postangioplasty restenosis (MLL 81.2±30.9 mm), and 30 (21.6%) for in-stent restenosis (MLL 117.0±39.5 mm). The primary outcome measure was freedom from binary restenosis as determined by a peak systolic velocity ratio ≥2.4 on duplex or >50% stenosis on digital subtraction angiography at 12 months. The secondary outcome was freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months. RESULTS: Technical success was achieved in all the 139 treated patients. During the hospital stay, 3 CLI patients died of wound-related complications and 3 CLI patients underwent urgent TLR due to early occlusion in 2 and stent thrombosis in 1. At 12 months, 4 additional patients died of cardiac disease unrelated to the procedure. Of the 132 patients available for 1-year follow-up, the primary outcome (freedom from restenosis) was obtained in 107 (81.1%) patients. Freedom from CD-TLR was obtained in 110 (83.3%). Of the 25 late restenoses >50%, only 3 asymptomatic patients did not require TLR. Freedom from CD-TLR was higher in claudicants (87.0%) than in CLI patients (78.2%, p=0.20). In patients treated for in-stent restenosis, freedom from TLR at 1 year was 89.2%. CONCLUSION: These data suggest that the use of a new generation paclitaxel-coated balloon represents a safe and effective therapeutic strategy for femoropopliteal obstructions in different clinical and anatomical settings. These data will need to be confirmed with longer-term follow-up and in randomized controlled trials.

Focus on Prevention: Peripheral Arterial Disease and the Central Role of the Cardiologist.

Peripheral artery disease (PAD) is a manifestation of systemic atherosclerotic disease. PAD patients have a poor prognosis with an increased risk of cardiovascular (CV) events, including myocardial infarction (MI), stroke, limb ischemia and CV death; therefore, it is important to detect and treat PAD early. PAD and coronary artery disease (CAD) share a common pathogenesis and risk factors for development; therefore, cardiologists are in a unique position to screen, diagnosis and treat PAD. Moreover, PAD and CAD also share some treatment goals, including an aggressive modification of risk factors to reduce the risk of CV events. However, PAD remains an underdiagnosed and undertreated disease with medico-legal implications. As the role of cardiologists is expanding, the purpose of this review was to awaken the clinicians to the significance of PAD.

Proximal versus distal protection: dissecting clinical trials.

Carotid artery stenting (CAS) is a valid alternative to conventional carotid endarterectomy for treatment of carotid artery stenosis. Distal embolization of atherosclerotic debris causing cerebrovascular accidents during CAS has been the most significant concern limiting widespread application of CAS technology. A variety of embolic protection devices (EPDs) with different mechanism of action, have been designed to minimize the risk of major embolization causing stroke and their use is recommended by current guidelines. Two general types of EPDs are available: proximal protection devices (PPDs) and distal protection devices (DPDs). However, there is no convincing clinical evidence of the clinical superiority of one device over another. This review will examine the different types of available devices and also innovative devices and techniques, including strengths and weaknesses of each, and present the available evidence and rationale for their routine use during CAS.

Predictors of adherence to composite therapy after acute coronary syndromes.

AIMS: Adherence to medical therapy following acute coronary syndrome (ACS) affects a patient's prognosis. In this cohort study, we sought to assess the factors that could affect a patient's adherence to therapy after ACS. METHODS: We prospectively collected information from patients (N = 964) hospitalized at the coronary care unit of the Federico II University Hospital, from 1 January 2015 to 30 June 2017, for ACS. Adherence to three classes of drugs including statins, antiplatelets [dual or single antiplatelet agent (SAPT)] and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACE-I/ARB) and their composites were assessed at 1 month, 1 and 2 years after discharge. RESULTS: At 30 days adherence to prescribed therapy was 94.4% for dual antiplatelet therapy (DAPT), 78.2% for statins, 92.7% for ACE-I/ARB and 70.7% for multitherapy. At 1 year, it was 91.1% for DAPT, 81.2% for ACE-I/ARB, 84.9% for statins and 71.4% for multitherapy. At 2 years, it was 97.1% for SAPT, 78.1% for ACE-I/ARB, 91.8% for statins, 72.8% for multitherapy. Multivariable logistic analysis demonstrated that at each time point, a telephone follow-up assessment predicts nonadherence to multitherapy and that a percutaneous coronary intervention at the index hospitalization is an independent predictor of adherence to composite therapy at 1 month and 1 year. CONCLUSION: Up to 2 years after ACS, three out of four patients are adherent to multitherapy prescription; percutaneous coronary intervention during the index hospitalization improves a patient's adherence, whereas telephone follow-up is associated with reduced adherence to multitherapy.Campania Salute Network Registry (Clinical Trials.gov Identifier: NCT02211365).

[Antithrombotic therapy in lower extremity arterial disease]. / Terapia antitrombotica dell'arteriopatia ostruttiva degli arti inferiori.

Lower extremity arterial disease (LEAD) affects over 200 million people worldwide but, as of today, is not adequately treated and represents an important cause of morbidity, mortality and disability. Although the use of antithrombotic therapy is recommended to prevent cardiovascular adverse events, patients with LEAD often receive inadequate prescription for antithrombotic agents (antiplatelets and anticoagulants). Historically, the inadequate use of antithrombotic drugs in this clinical setting has been ascribed to the lack of high quality scientific data obtained from clinical trials enrolling patients with LEAD. However, the results of more recent clinical trials support the use of antithrombotic drugs for these patients. The aim of this article is to summarize the available evidence supporting the prescription of antithrombotic agents in patients with LEAD.

Drug-coated balloon in superficial femoral artery in-stent restenosis.

The femoropopliteal artery is one of the commonest sites of involvement in peripheral artery disease (PAD) leading to intermittent claudication and/or critical limb ischemia. Endovascular therapy for superficial femoral artery (SFA) disease has been recognized as a safe and efficient therapy and is recommended by current guidelines as the first-line approach. Although the widespread use of new-generation, self-expanding, nitinol stents in SFA stenosis has reduced the shortcomings associated with plain old balloon angioplasty (POBA), lumen renarrowing at the stented (in-stent restenosis - ISR) level still represents a relevant clinical problem, because of higher risk of recurrent ISR, occlusion and surgical revascularization compared to de-novo lesions. In this setting, different treatment options are available and drug-coated balloons (DCBs) have shown good results in terms of safety and effectiveness. In this review we examine the results of different trials exploring the outcome of using DCBs for the treatment of SFA ISR. The available data demonstrate that SFA ISR can be safely treated with percutaneous transluminal angioplasty with a DCB, with a reduction in recurrent restenosis and target lesion revascularization (TLR) at least at 1 year after POBA. The consistent and positive results of different registries and randomized trials support the use of DCB to reduce SFA ISR recurrence.

Work-related outcome after acute coronary syndrome: Implications of complex cardiac rehabilitation in occupational medicine.

OBJECTIVES: Coronary heart disease is frequent in the working-age population. Traditional outcomes, such as mortality and hospital readmission, are useful for evaluating prognosis. Fit-for-work is an emerging outcome with clinical as well as socioeconomic significance. We describe the possible benefit of a cardiac rehabilitation (CR) program for return to work (RTW) after acute coronary syndrome (ACS). MATERIAL AND METHODS: We evaluated 204 patients with recent ACS. They were divided into 4 groups on the basis of their occupational work load: very light (VL), light (L), moderate (M), and heavy (H). Work-related outcomes were assessed with the Work Performance Scale (WPS) of the Functional Status Questionnaire and as "days missed from work" (DMW) in the previous 4 weeks. The variables considered for outcomes were percent ejection fraction, functional capacity expressed in metabolic equivalents (METs), and participation or non-participation in the CR program (CR+ and CR-). RESULTS: One hundred thirty (66%) patients took part in the CR program. Total WPS scores for CR+ and CR- subgroups were VL group: 18±4 vs. 14±4 (p < 0.001), L group: 18±3 vs. 14±3 (p < 0.0001), M group: 19±3 vs. 16±3 (p < 0.003), and H group: 20±4 vs. 17±3 (p < 0.006). Fewer DMW were reported by the CR+ group. CONCLUSIONS: Non-participation in CR was a consistent cause of poorer work-related outcomes. Our findings indicate that CR and occupational counseling play a very important role in worker recovery and subsequent reintegration in the workplace, in particular among clerical workers.

Single coronary artery originating from the right sinus Valsalva and ability to work.

We present a case of a 56-year-old male electrician who was admitted to the hospital with atrial fibrillation, atypical chest pain and dyspnea. He gave a history that on the morning he had working for almost 4 hours carrying out various activities with considerable physical effort. After cardioversion, conventional coronary angiography revealed a suspect of single coronary vessel (SCA) arising from the right sinus of Valsalva. The patient underwent multislice computed tomography that showed a SCA arising from the right sinus Valsalva and dividing in Right Coronary Artery (RCA) and Left Main coronary artery (LM). The finding of posterior course of the LM without atherosclerotic has proved crucial for the expression of an opinion of working capacity even with limitation.