[Endovascular devices for severely calcified peripheral lesion preparation: state of the art]. / Dispositivi per la preparazione delle lesioni calcifiche del distretto periferico: stato dell'arte.

Over the last few decades, endovascular revascularization techniques have revolutionized the treatment of peripheral artery disease, offering a less invasive alternative to surgery. However, the successful treatment of heavily calcified lesions is often compromised by various vascular complications, including recoils, dissections, and the need for target vessel reinterventions. This has prompted the development of several tools for lesion preparation, with the aim of achieving better procedural outcomes. This review aims to summarize the main characteristics and current evidence related to the available devices for preparing severely calcified peripheral lesions.

Sirolimus-Coated Balloon in Femoropopliteal Steno-Occlusive Disease: Efficacy, Safety, and 1-Year Outcomes. An All-Comers Registry.

PURPOSE: The aim of this study was to assess the efficacy and safety of the novel SLR (SELUTION sustained-limus-release) drug-coated balloon (DCB) in the treatment of the femoropopliteal steno-occlusive disease. MATERIALS AND METHODS: From February 2021 to March 2022, 80 consecutive patients (age: 69.5±8.23 years; total number of lesions: 80) with a steno-occlusive lesion of superficial femoral artery were enrolled at our center. A total of 60 patients (75%) had claudication, whereas 20 (25%) had chronic limb-threatening ischemia (CLTI). The mean lesion length was 171±82.22 mm. The primary efficacy outcome was primary patency at 12 months, defined as freedom from restenosis determined by a duplex ultrasound peak systolic velocity ratio ≤2.4. The secondary efficacy outcome was freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months. The primary safety outcome was a composite of freedom from device- and procedure-related mortality, major target limb amputation, and clinically-driven target lesion urgent revascularization (endovascular or bypass graft) at 30 days and 12 months. RESULTS: Device success was achieved in all 80 patients. One death on day 7 from cardiovascular complications was ruled procedure-related because it occurred within the first 30 days from the discharge. Two patients with CLTI experienced planned minor amputations of target limb, and one patient underwent urgent bypass graft of the target vessel for early occlusion at 60 days from the index procedure. The primary safety outcome was 98.7% and 97.5% at 30 days and 12 months, respectively. At 1 year, primary patency was 86.3%, and freedom from CD-TLR was 96.2%. CONCLUSION: These findings suggest that using a novel sirolimus-coated balloon is a safe and effective treatment option for femoropopliteal steno-occlusive lesions in a variety of clinical and anatomical settings. These results will need to be confirmed by long-term follow-up and randomized controlled trials. CLINICAL IMPACT: In femoropopliteal steno-occlusive lesions paclitaxel drug-coated devices have been proved to be able to achieve a better vessel patency during follow-up compared with uncoated balloon, but according to a recent meta-analysis they may carry an elevated risk of late mortality. Sirolimus results in a wider therapeutic range with a 3-fold higher margin of safety. Sirolimus coated devices have recently been proposed as an alternative. This study suggests that using a novel sirolimus-coated balloon is a safe and effective treatment option for femoropopliteal steno-occlusive lesions.

Assessing the impact of transcatheter aortic valve replacement on myocardial work indices and left ventricular diastolic function in aortic valve stenosis patients.

BACKGROUND: Aortic valve stenosis (AS) is the most common valvular heart disease worldwide. When timely intervention is performed, aortic valve replacement can improve patients' quality and duration of life. Load-independent left ventricular (LV) functional assessments, such as myocardial work indices (MWIs) and LV diastolic function parameters, could help clinicians decide on the optimal timing of intervention. AIMS: To evaluate the reliability of MWI in AS patients and the changes in MWI and LV diastolic function after transcatheter aortic valve replacement (TAVR). METHODS: We enrolled 53 consecutive patients with severe AS undergoing TAVR admitted between March 2021 and November 2021. MWIs and LV diastolic function were assessed before and after TAVR for each patient. RESULTS: All MWIs and LV diastolic function indices improved after TAVR. The degree of MWIs improvement was higher in patients with lower prior-TAVR MWI values, while the more severe the impairment of diastolic function, the greater the post-TAVR benefit. CONCLUSION: The introduction of myocardial work parameters into the routine assessment of patients with AS could improve our understanding of cardiac performance and aid in identifying the optimal timing for surgical or percutaneous treatment.

Carotid Artery Stenting Using Five-French Distal Radial Vascular Access.

Carotid artery stenting (CAS) is usually performed through a femoral vascular access using 6-9 Fr guiding catheters. We investigated whether a systematic distal radial approach using 5 Fr guiding sheaths was a safe and effective alternative to transfemoral approach for CAS. From July 2020 to October 2022, two operators at our center systematically performed CAS using a 5 Fr distal radial approach in consecutive patients. The main endpoints of the study were procedural success via distal radial and via proximal or distal radial access. The learning curve was evaluated by comparing the first half of patients versus the second half of patients enrolled. Procedural data and 30-day clinical outcomes were collected. Fifty-one patients were prospectively enrolled. CAS was effectively performed via distal radial access in 45 patients (88%). Overall radial artery success was 92%. Distal radial CAS was successfully performed in 20 out of the first 25 patients enrolled (80%), and in 25 of the last 26 patients enrolled (96%; p = 0.07). Significantly less contrast was administered in the last 26 patients compared to the first 25 enrolled (110 (70, 140) mL vs. 120 (107, 150) mL; p = 0.045). Radial artery occlusion was reported in 1 patient (2%). Only 1 minor stroke (2%) was reported in-hospital and at 30-day follow-up. In conclusion, distal radial CAS using 5 Fr catheters was a safe procedure with a high success rate. The procedure had a relatively short learning curve in operators familiar with transfemoral CAS.

Combined therapy with rotational atherectomy and drug coated balloon for superficial femoral artery in-stent restenosis: safety, efficacy, and two-year results of a single center experience.

BACKGROUND: The primary patency rate of superficial femoral artery (SFA) after percutaneous transluminal angioplasty (PTA) has improved with the use of self-expanding stents. However, occurrence of in-stent restenosis (ISR) still represents a frequent problem. Despite different studies have assessed the role of atherectomy and drug coated balloons (DCBs), no long-term data exist about combined use. The aim of this study was to evaluate safety and efficacy of combined treatment with Jetstream (Boston Scientific Corp., Marlborough, MA, USA) atherectomy and DCB for SFA intrastent restenosis (ISR) at 2-year follow-up. METHODS: 30 patients treated with PTA from November 2018 to September 2019 at Montevergine Clinic (Mercogliano, Avellino, Italy) were included in this analysis. All patients underwent PTA of SFA-ISR with Jetstream Atherectomy System followed by paclitaxel eluting balloon treatment. Patients were evaluated at 30 days, and every 3 months up to 24. RESULTS: Technical and procedural success was achieved in every patient. No in-hospital major adverse cardiac and cerebrovascular events occurred. No acute and sub-acute(in-hospital) procedure related complications occurred. During follow-up, 1 patient died due to stroke. Primary patency rate at 12 months was 93.4%. Primary patency rate at 24 months was 83.4%. Secondary patency rate at 24 months was 96.7%. One minor amputation, planned before treatment, was performed in the first 30 days. CONCLUSIONS: Our data suggest that combined therapy with Rotational Atherectomy and DCBs for SFA-ISR represents a safe and effective procedure with a high rate of primary patency at 2-year follow-up.

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.

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).

Access-Site Crossover in Patients With Acute Coronary Syndrome Undergoing Invasive Management.

OBJECTIVES: The aim of this study was to assess the impact of access-site crossover in patients with acute coronary syndrome undergoing invasive management via radial or femoral access. BACKGROUND: There are limited data on the clinical implications of access-site crossover. METHODS: In the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox)-Access trial, 8,404 patients with acute coronary syndrome were randomized to radial or femoral access. Patients undergoing access-site crossover or successful access site were investigated. Thirty-day coprimary outcomes were a composite of death, myocardial infarction, or stroke (major adverse cardiovascular events [MACE]) and a composite of MACE or Bleeding Academic Research Consortium type 3 or 5 bleeding (net adverse clinical events [NACE]). RESULTS: Access-site crossover occurred in 183 of 4,197 patients (4.4%) in the radial group (mainly to femoral access) and 108 of 4,207 patients (2.6%) in the femoral group (mainly to radial access). In multivariate analysis, the risk for coprimary outcomes was not significantly higher with radial crossover compared with successful radial (MACE: adjusted rate ratio [adjRR]: 1.25; 95% confidence interval [CI]: 0.81 to 1.93; p = 0.32; NACE: adjRR: 1.40; 95% CI: 0.94 to 2.06; p = 0.094) or successful femoral access (MACE: adjRR: 1.17; 95% CI: 0.76 to 1.81; p = 0.47; NACE: adjRR: 1.26; 95% CI: 0.86 to 1.86; p = 0.24). Access site-related Bleeding Academic Research Consortium type 3 or 5 bleeding was higher with radial crossover than successful radial access. Femoral crossover remained associated with higher risks for MACE (adjRR: 1.84; 95% CI: 1.18 to 2.87; p = 0.007) and NACE (adjRR: 1.69; 95% CI: 1.09 to 2.62; p = 0.019) compared with successful femoral access. Results remained consistent after excluding patients with randomized access not attempted. CONCLUSIONS: Crossover from radial to femoral access abolishes the bleeding benefit offered by the radial over femoral artery but does not appear to increase the risk for MACE or NACE compared with successful radial or femoral access. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox [MATRIX]; NCT01433627).

Prognostic Implications of Declining Hemoglobin Content in Patients Hospitalized With Acute Coronary Syndromes.

BACKGROUND: Contemporary definitions of bleeding endpoints are restricted mostly to clinically overt events. Whether hemoglobin drop per se, with or without overt bleeding, adversely affects the prognosis of patients with acute coronary syndrome (ACS) remains unclear. OBJECTIVES: The aim of this study was to examine in the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) trial the incidence, predictors, and prognostic implications of in-hospital hemoglobin drop in patients with ACS managed invasively stratified by the presence of in-hospital bleeding. METHODS: Patients were categorized by the presence and amount of in-hospital hemoglobin drop on the basis of baseline and nadir hemoglobin values and further stratified by the occurrence of adjudicated in-hospital bleeding. Hemoglobin drop was defined as minimal (<3 g/dl), minor (≥3 and <5 g/dl), or major (≥5 g/dl). Using multivariate Cox regression, we modeled the association between hemoglobin drop and mortality in patients with and without overt bleeding. RESULTS: Among 7,781 patients alive 24 h after randomization with available hemoglobin data, 6,504 patients (83.6%) had hemoglobin drop, of whom 5,756 (88.5%) did not have overt bleeding and 748 (11.5%) had overt bleeding. Among patients without overt bleeding, minor (hazard ratio [HR]: 2.37; 95% confidence interval [CI]: 1.32 to 4.24; p = 0.004) and major (HR: 2.58; 95% CI: 0.98 to 6.78; p = 0.054) hemoglobin drop were independently associated with higher 1-year mortality. Among patients with overt bleeding, the association of minor and major hemoglobin drop with 1-year mortality was directionally similar but had wider CIs (minor: HR: 3.53 [95% CI: 1.06 to 11.79]; major: HR: 13.32 [95% CI: 3.01 to 58.98]). CONCLUSIONS: Among patients with ACS managed invasively, in-hospital hemoglobin drop ≥3 g/dl, even in the absence of overt bleeding, is common and is independently associated with increased risk for 1-year mortality. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox; NCT01433627).

A cross-sectional study evaluating hospitalization rates for chronic limb-threatening ischemia during the COVID-19 outbreak in Campania, Italy.

The expansion of coronavirus disease 2019 (COVID-19) prompted measures of disease containment by the Italian government with a national lockdown on March 9, 2020. The purpose of this study is to evaluate the rate of hospitalization and mode of in-hospital treatment of patients with chronic limb-threatening ischemia (CLTI) before and during lockdown in the Campania region of Italy. The study population includes all patients with CLTI hospitalized in Campania over a 10-week period: 5 weeks before and 5 weeks during lockdown (n = 453). Patients were treated medically and/or underwent urgent revascularization and/or major amputation of the lower extremities. Mean age was 69.2 ± 10.6 years and 27.6% of the patients were women. During hospitalization, 21.9% of patients were treated medically, 78.1% underwent revascularization, and 17.4% required amputations. In the weeks during the lockdown, a reduced rate of hospitalization for CLTI was observed compared with the weeks before lockdown (25 vs 74/100,000 inhabitants/year; incidence rate ratio: 0.34, 95% CI 0.32-0.37). This effect persisted to the end of the study period. An increased amputation rate in the weeks during lockdown was observed (29.3% vs 13.4%; p < 0.001). This study reports a reduced rate of CLTI-related hospitalization and an increased in-hospital amputation rate during lockdown in Campania. Ensuring appropriate treatment for patients with CLTI should be prioritized, even during disease containment measures due to the COVID-19 pandemic or other similar conditions.

[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.

ECG analysis in patients with acute coronary syndrome undergoing invasive management: rationale and design of the electrocardiography sub-study of the MATRIX trial.

BACKGROUND: The twelve­lead electrocardiogram (ECG) has become an essential tool for the diagnosis, risk stratification, and management of patients with acute coronary syndromes (ACS). However, several areas of residual controversies or gaps in evidence exist. Among them, P-wave abnormalities identifying atrial ischemia/infarction are largely neglected in clinical practice, and their diagnostic and prognostic implications remain elusive; the value of ECG to identify the culprit lesion has been investigated, but validated criteria indicating the presence of coronary occlusion in patients without ST-elevation are lacking; finally, which criteria among the multiple proposed, better define pathological Q-waves or success of revascularisation deserve further investigations. METHODS: The Minimizing Adverse hemorrhagic events via TRansradial access site and systemic Implementation of AngioX (MATRIX) trial was designed to test the impact of bleeding avoidance strategies on ischemic and bleeding outcomes across the whole spectrum of patients with ACS receiving invasive management. The ECG-MATRIX is a pre-specified sub-study of the MATRIX programme which aims at analyzing the clinical value of ECG metrics in 4516 ACS patients (with and without ST-segment elevation in 2212 and 2304 cases, respectively) with matched pre and post-treatment ECGs. CONCLUSIONS: This study represents a unique opportunity to further investigate the role of ECGs in the diagnosis and risk stratification of ACS patients with or without ST-segment deviation, as well as to assess whether the radial approach and bivalirudin may affect post-treatment ECG metrics and patterns in a large contemporary ACS population.

[Role of carotid artery stenting in stroke prevention]. / Ruolo della rivascolarizzazione carotidea percutanea nella prevenzione dell'ictus.

Carotid revascularization is an effective method of primary and secondary prevention of ischemic cerebral stroke in patients presenting with extracranial carotid atherosclerosis leading to significant stenosis of the internal carotid artery. Currently, the European guidelines recommend surgical revascularization in all symptomatic patients with >50% stenosis with a documented periprocedural death/stroke risk of <6%. Endovascular revascularization should be considered in symptomatic patients with anatomical and clinical features that contribute to making such patients at high surgical risk. According to the guidelines, revascularization should be considered in patients with >60% stenosis, in the presence of clinical and/or imaging features associated with an increased risk of ipsilateral stroke (in the presence of documented risk of perioperative stroke/death <3% and patient's life expectancy >5 years). In patients with low and/or average surgical risk should be considered carotid endarterectomy, while in patients who are deemed at high surgical risk carotid stenting should be considered.Nowadays, thanks to technological advances and improved operators' experience, carotid stenting can be considered a valuable therapeutic strategy.