Radial access for peripheral vascular intervention: the S.M.A.R.T. RADIANZ Vascular Stent System.

INTRODUCTION: Radial access is the standard of care for nearly all cardiac catheterization procedures. It improves patient satisfaction, reduces the length of stay, and is associated with fewer complications. However, few devices and tools are available for the treatment of peripheral arterial disease via a transradial approach (TRA). The S.M.A.R.T. RADIANZ Vascular Stent System is among the RADIANZ suite of products, which is aimed at expanding the portfolio of devices to treat peripheral arterial disease. AREAS COVERED: In this Expert review, the following areas will be covered: (1) Current Landscape of peripheral vascular intervention (PVI) using TRA (2) Detailed description of the S.M.A.R.T. RADIANZ Vascular Stent System. (3) Ongoing clinical trials to evaluate safety of this approach. (4) Future directions and current regulatory status. EXPERT OPINION: TRA for PVI is a promising approach. It holds the possibility of substantially improving the care of patients with peripheral arterial disease (PAD). Numerous challenges must be overcome to realize the full potential of a radial-to-peripheral (RTP) approach. The length of devices and the small sheath size are the main constraints of this approach. The results of the ongoing RADIANCY trial will demonstrate the safety, in selected patients, of the RADIANZ suite of products.

[Robotic percutaneous coronary intervention: current evidence, practical aspects and future perspectives]. / L'angioplastica coronarica robotica: evidenze scientifiche, aspetti pratici e prospettive future.

Robotic percutaneous coronary intervention (R-PCI) is an emerging technology designed to improve operator safety and procedural precision. The interventional cardiologist is able to manipulate guidewires, catheters and devices from a specific cockpit. A number of studies evaluating R-PCI have shown high procedural success rates with low complications. R-PCI advantages include the possibility to perform an accurate stent positioning, to reduce the operator radiation exposure and orthopedic injuries. However, there is a limited experience regarding R-PCI in complex anatomies, that may still require manual assistance. Moreover, the technique is limited by current incompatibility with specific materials, the lack of tactile feedback and the possibility to robotically manage only one wire/device at the same time. Globally, R-PCI is a novel approach with future interesting implications, but further investigations are necessary to overcome current limitations.

Limb salvage in diabetic patients with no-option critical limb ischemia: outcomes of a specialized center experience.

Objective: To describe the characteristics, the management and the outcome of a consecutive series of patients with diabetic foot lesions (DF) and no-option critical limb ischemia (CLI) treated with a multidimensional, interdisciplinary approach in a dedicated center. Research Design and Methods: The prospective database of the Diabetic Foot Unit of the Maria Cecilia Hospital (Cotignola, Italy) collects medical history, risk factors, chemistry values, angiographic data, characteristic of foot lesions, medical and surgical therapies of all patients admitted with a diagnosis of DF and CLI. All patients were followed-up for at least 1 year and/or total recovery. The primary endpoint was 1-year amputation-free survival (AFS), secondary endpoints were limb salvage and survival. Results: Between October 2014 and October 2017, 1024 patients with DF and CLI were admitted to the center. Eighty-four of them (8.2%) fulfilled the criteria for no-option CLI. At 1 year, AFS, limb salvage, and survival rates were 34%, 34%, and 83%, respectively. Lesions located proximal to the Lisfranc joint were associated with major amputation (HR 2.1 [1.2-3.6]). One-year survival of patients treated with minor procedures was significantly higher compared to patients treated with major amputation (96% vs 76%, log-rank p = 0.019). Major amputation was independently associated with mortality (HR 7.83 [1.02-59.89]). Conclusions: The application of dedicated and standardized strategies permitted limb salvage in one-third of patients with no-option CLI. Patients with stable lesions limited to the forefoot and without ischaemic pain had a greater probability to successfully receive conservative treatments. Limb salvage was associated with subsequent higher one-year survival.

[Bioresorbable vascular scaffolds: clinical experience of the Emilia-Romagna Region, Italy]. / Scaffold bioriassorbibile: l'esperienza clinica della Regione Emilia-Romagna.

BACKGROUND: The bioresorbable vascular scaffold (BRS) technology constitutes the new revolution of the coronary artery disease interventional treatment. Currently, three distinct types of BRSs are available but only one, the Absorb BVS, was on the market in 2013 when the Regional Commission for Medical Devices and the Cardiology and Cardiac Surgery Commission of the Emilia-Romagna Region drew up a technical and scientific essay to provide guidance for the introduction of BRS in public and affiliated health facilities. Five preferential indications were given for use: long coronary lesions (>28 mm), ostial lesions (left main stem excluded), complete revascularization in patients aged <50 years, diffuse disease (>40 mm) or involving the mid/distal left anterior descending (LAD) branch in patients <70 years, spontaneous coronary artery dissection. METHODS: This survey analyzed data from all the catheterization laboratories in the Emilia-Romagna Region, merged in a unified database. RESULTS: In a 3-year study period, 546 BRS were implanted in 328 patients, corresponding to 1.5% of the drug-eluting stents (DES) used, with a trend towards a progressive increase over time. Initial indications were followed in 200/328 (61.0%) patients (about one third fitting more indications), mainly for treatment of long lesions in vessels >2.5 mm (67%), young patients (31.5%) and mid/distal LAD (28%). In 22.6% of cases the clinical scenario was a ST-segment elevation myocardial infarction, in 39.3% a non-ST-segment elevation acute coronary syndrome. Intracoronary imaging was infrequently used (intravascular ultrasound in 24.7% of cases). In 85 patients (25.9%) a hybrid procedure (BVS/DES) was performed. CONCLUSIONS: BRS use has resulted lower than expected, with discrete variability among centers, but according to the initial indications of the Emilia-Romagna Region in the majority of cases. The underuse might have been due to operators' caution in their initial experience. However, the increasing trend may reveal a greater confidence in the implantation technique and the whole amount of safety and efficacy data.

Carotid artery stenting with a new-generation double-mesh stent in three high-volume Italian centres: clinical results of a multidisciplinary approach.

AIMS: Carotid artery stenting (CAS) is still associated with higher periprocedural cerebrovascular events (CEs) compared to vascular surgery. The Roadsaver carotid artery stent is a double layer micromesh stent which reduces plaque prolapse and embolisation by improving plaque coverage. Its clinical impact on neurological outcome was unknown. The aim of this study was therefore to report the clinical results of a large real-world population from three different centres receiving a Roadsaver stent to treat carotid artery disease. METHODS AND RESULTS: One hundred and fifty (150) patients (age 74±8 yrs, 75% male, symptomatic 29%) treated with CAS using the Roadsaver carotid stent in three high-volume Italian centres were included in the study. Intraprocedural optical coherence tomography (OCT) evaluation was performed in 26 patients, with an off-line analysis by a dedicated core laboratory. All patients underwent duplex ultrasound and neurological evaluation at 24 hours and at 30 days. CAS was technically successful in all cases (stent diameter: 8.6±0.8 mm, stent length: 25.0±4.5 mm). No in-hospital or 30-day CEs were observed. OCT evaluation detected a low rate of plaque prolapse (two patients, 7.7%). Duplex ultrasound showed stent and external carotid artery patency in all cases both before discharge and at 30-day follow-up. CONCLUSIONS: The Roadsaver stent is a safe and promising technology for CAS, with a low percentage of plaque prolapse and good short-term clinical outcome. Larger studies with longer follow-up are necessary to confirm this favourable clinical outcome.

Emergency balloon aortic valvuloplasty in patients with critical aortic stenosis presenting with cardiogenic shock.

This report describes 2 cases of aortic valvuloplasty performed as emergency treatment in patients with critical aortic stenosis presenting with cardiogenic shock. This procedure can be life-saving, and allows the patients to undergo further evaluation for aortic valve replacement, or other definitive treatments such as the recently developed percutaneous heart valve implantation for patients with unacceptably high surgical risk.

[Use of carbon dioxide as contrast agent to perform balloon angioplasty of the superficial femoral artery in a patient with severe renal impairment]. / Impiego dell'anidride carbonica come mezzo di contrasto per l'esecuzione di angioplastica con pallone dell'arteria femorale superficiale in presenza di insufficienza renale severa.

Endovascular treatment of symptomatic atherosclerotic peripheral artery disease has gained widespread acceptance and is now recommended as the primary revascularization strategy in many clinical and interventional settings. Nevertheless, endovascular strategy finds a relative contraindication in patients affected by severe chronic kidney disease, because of nephrotoxicity of iodinated contrast medium. Carbon dioxide (CO2) angiography permits to obtain vascular angiography without the use of a iodinated contrast medium, therefore it is ideal in chronic kidney disease patients because it is not nephrotoxic and does not have appreciable medical contraindications. In this report we describe a case of percutaneous transluminal angioplasty of an occluded left superficial femoral artery using CO2as contrast medium, because of severe chronic kidney disease (glomerular filtration rate 28 ml/min/1.73 m²). This complex procedure required double vascular access with retrograde popliteal access associated with femoral access, which was performed successfully despite a very low use of iodinated contrast medium. This case report is also the starting point for a review of literature data regarding CO2 use for peripheral intervention.

Sex-Related Outcomes in Elderly Patients Presenting With Non-ST-Segment Elevation Acute Coronary Syndrome: Insights From the Italian Elderly ACS Study.

OBJECTIVES: This study sought to investigate sex-related differences in treatment and outcomes in elderly patients with non-ST-segment elevation acute coronary syndromes (NSTEACS). BACKGROUND: Female sex and older age are usually associated with worse outcome in NSTEACS. The Italian Elderly ACS study enrolled NSTEACS patients aged 75 years of age and older in a randomized trial comparing an early aggressive with an initially conservative strategy and in a registry of patients with ≥1 exclusion criteria of the trial. METHODS: We compared sexes in the pooled populations of the trial and registry. RESULTS: A total of 645 patients (313 from the trial and 332 from the registry), including 301 women (47%), were enrolled. Women were slightly older than men (82.1 ± 5.0 years vs. 81.2 ± 4.5 years; p = 0.02), had lower hemoglobin levels (12.5 ± 1.6 g/dl vs. 13.3 ± 1.9 g/dl; p < 0.001), and underwent fewer coronary revascularizations during the index admission (37.2% vs. 45.0%; p = 0.04). In-hospital adverse event rates were similar in both sexes; severe bleeding was uncommon (0.3% vs. 0%). The 1-year primary endpoint (composite of death, nonfatal myocardial infarction, disabling stroke, cardiac rehospitalization, and severe bleeding) occurred less often in women (27.6% vs. 38.7%; p < 0.01). Women not undergoing revascularization showed a 3-fold higher mortality, both in-hospital (8.5% vs. 2.7%; p = 0.05) and at 1 year (21.6% vs. 8.1%; p = 0.002). CONCLUSIONS: Elderly women had a similar in-hospital outcome and better 1-year outcome compared with men. Coronary revascularization in women was associated with lower 1-year mortality, without an increase in severe bleeding. Elderly women with NSTEACS should always be considered for early revascularization.

Clinical relevance of homocysteine levels in patients receiving coronary stenting for unstable angina.

BACKGROUND: We prospectively investigated whether plasma homocysteine (HCY) concentrations are related to target lesion revascularization (TLR) rates in patients with unstable angina undergoing stenting. METHODS: We enrolled 196 consecutive patients with at least one successful coronary stent implantation for unstable angina. RESULTS: The mean vessel diameter was 3.1 +/- 0.5 mm. At follow-up (17.8 +/- 7.5 months), patients with higher HCY levels (> 17 micromol/l, 4th quartile) had similar TLR rates to the rest of the sample (11.1 vs 13.2%, p = 0.90). On the other hand, high HCY levels did seem to be associated with higher total (13.3 vs 0.7%, p = 0.001) and cardiac (6.7 vs 0%, p = 0.01) mortality rates. At multivariate analysis, only target vessel diameter independently predicted TLR, while both HCY levels and target vessel size predicted late total mortality. CONCLUSIONS: At least in patients with a mean vessel diameter > 3 mm, HCY levels cannot be taken as a prognostic indicator of in-stent restenosis for patients with unstable angina. However, in spite of successful percutaneous revascularization, HCY values do seem to strongly influence late mortality.

[Intracoronary beta-radiotherapy in high-risk in-stent restenosis. Prospective results of a single center registry]. / Efficacia a lungo termine della brachiterapia endocoronarica beta (32P) nel trattamento delle ristenosi intrastent ad elevato rischio. Risultati prospettici di un registro monocentrico.

BACKGROUND: The aim of the study was to evaluate, on single center prospective data, long-term angiographic and clinical results of intracoronary beta (32P) brachytherapy in "real world" patients with high-risk in-stent restenosis lesions. METHODS: Sixty-nine consecutive patients (77 lesions) with high-risk in-stent restenosis (mean lesion length 30.3 +/- 16.1 mm, pattern III-IV 57.2%, diabetes 33.3%) treated with percutaneous dilation procedures and beta-radiation therapy, underwent 7-month clinical and angiographic follow-up. RESULTS: One patient (1.4%) presented with procedural non-Q wave myocardial infarction. At a mean follow-up of 7 +/- 1.5 months, death was observed in 1 patient (1.4%) and non-Q wave myocardial infarction in 3 (4.3%) (in 2 patients, who prematurely discontinued antiplatelet therapy, caused by late coronary thrombosis). Seven-month binary angiographic restenosis occurred in 20 lesions (25.9%) (in-stent restenosis 11.6%). Target lesion and target vessel revascularization occurred in 20 (28.9%) and 21 (30.4%) patients. At follow-up only 12 (17.3%) patients presented with CCS class III-IV angina. After intracoronary beta brachytherapy angiographic restenosis occurred regardless of the vessel size, lesion length and ostial location. On the contrary a high restenosis rate was documented in obstructive lesions. CONCLUSIONS: As applied in routine clinical practice, radiation therapy is safe and effective in the treatment of high-risk in-stent restenosis. In spite of all that, total occlusion at baseline predicts late angiographic restenosis.

Safety and feasibility of iliac endovascular interventions with a radial approach. Results from a multicenter study coordinated by the Italian Radial Force.

BACKGROUND: Percutaneous angioplasty of lower limb disease is commonly performed with a transfemoral access. In the coronary field, a transradial approach has shown to reduce access-site bleeding and adverse clinical events. This route has not yet been well studied for the majority of peripheral interventions, like those involving the iliac arteries. In this study we sought to evaluate the feasibility and safety of this approach for iliac interventions. METHODS: Multicenter study was performed at high-volume centers with experience in transradial percutaneous interventions. Primary endpoint of the study was procedural success; secondary endpoints included in-hospital bleeding, 1-month freedom from adverse events and the rate of radial occlusion. Feasibility of this technique was evaluated by recording procedural and fluoroscopy time and contrast load. RESULTS: A total of 149 patients from 5 centers were enrolled. The population had a medium risk profile, with 48% of patients having TASC 2 or 3 lesions. Procedural success was achieved in 98.7% of the population, and we did not register in-hospital complications, including both vascular access site and procedural-related complications. An ancillary transfemoral approach was used in 13% of patients. One-month freedom from symptoms was achieved in 97.3% of patients, and the rate of radial occlusion was 2.7%. Major determinants of an unsuccessful procedure were the use of normal 6 or 7-Fr introducer with guiding catheter, TASC D lesion attempt, lesion length>30 mm and total occlusion. CONCLUSIONS: A transradial approach for iliac disease may be a feasible and safe alternative to the transfemoral route in experienced hands, in the light of significant technical improvements and dedicated devices.

[SICI-GISE position paper on the requirements for diagnostic and interventional procedures in patients with peripheral arterial disease]. / Documento di posizione SICI-GISE sui requisiti di processo diagnostico ed interventistico riferiti a pazienti affetti da patologia vascolare periferica.

Interventional procedures on peripheral vessels are the field of a novel specialty dedicated to the diagnosis and minimally invasive endovascular treatment of diseases involving the cerebral, thoracic and abdominal arteries (including renal and visceral arteries), as well as the peripheral arteries (femoro-popliteal arteries and the arteries below the knee). At present, physicians with three different types of medical training, each involving particular strengths and characteristics, specialize in endovascular treatment of patients with peripheral arterial disease: vascular surgeons, interventional radiologists and interventional cardiologists. Treatment of high-risk patients in terms of anatomical and clinical (serious comorbidities) complexity raised the need for the interventional cardiologist to face issues related to technical aspects of the procedure, multilevel pathology management and adequate indication. To achieve this goal, interventional cardiologists require particular facilities and clinical skills. The objectives of this position paper from the Italian Society of Interventional Cardiology (SICI-GISE) are (i) to define the theoretical background and practical training required to ensure that interventional cardiologists maintain high-quality standards also in the field of treatment of peripheral arterial disease, by establishing shared rules and drafting papers; (ii) to standardize the procedures of interventional cardiology operational units that treat patients with peripheral arterial disease in Italy on the basis of scientific evidence, and (iii) to establish common requirements in terms of facilities and regulations.

Prognostic value of isolated troponin I elevation after percutaneous coronary intervention.

BACKGROUND: Mild elevations of cardiac troponin are frequent after percutaneous coronary intervention (PCI). Their prognostic value is uncertain in the absence of changes in creatine kinase-MB (CK-MB). METHODS AND RESULTS: We evaluated the relation between isolated elevations of cardiac troponin I (cTnI) and all-cause mortality. We studied 3494 consecutive patients who underwent PCI in 16 Italian tertiary cardiology centers. CK-MB and cTnI were analyzed in a central laboratory. Duration of follow-up was 2 years. The present analysis was restricted to 2362 patients with normal CK-MB and cTnI values at baseline and no CK-MB elevation after PCI. A rise in cTnI after PCI >0.15 ng/mL, the upper reference limit, was found in 932 patients (39.4%). A rise >0.45 ng/mL (>3×upper reference limit) was found in 467 patients (19.7%). Compared with patients with normal cTnI, those with cTnI elevation >0.15 ng/mL showed a slightly increased mortality (3.8% versus 2.6%; hazard ratio, 1.53; 95% confidence interval, 0.97 to 2.42; P=0.069). A cTnI elevation >0.45 ng/mL was associated with a higher risk of mortality (4.5% versus 2.7%; hazard ratio, 1.68; 95% confidence interval, 1.01 to 2.80; P=0.044), which, however, did not remain significant after adjustment for concomitant risk factors (hazard ratio, 1.45; 95% confidence interval, 0.86 to 2.46; P=0.162). Postprocedural cTnI elevation was associated with coronary and clinical features consistent with a worse risk profile. CONCLUSIONS: In the absence of a rise in CK-MB, elevated cTnI levels after PCI are associated with a modest increased risk of death. However, this is not independent of the concomitant adverse baseline clinical characteristics of these patients.

[Late stent thrombosis after drug-eluting stent implantation: epidemiological, clinical and pathophysiological aspects]. / Trombosi tardiva dopo impianto di stent medicato: aspetti epidemiologici, clinici e fisiopatologici.

Stent thrombosis (ST) is an uncommon, but potentially catastrophic, complication of percutaneous coronary intervention, since it can be associated with acute myocardial infarction and death. The advent of drug-eluting stents (DES) has raised concerns regarding numerous reports about very-late occurrences of ST. Data from the literature seem to suggest an increased incidence of ST in patients treated with DES vs bare-metal stents after the first year from percutaneous coronary intervention (very-late ST). The magnitude of this phenomenon is quite modest in absolutely value (between 0.35% and 0.6% per year) and it does not translate into a worse hard outcome (death and myocardial infarction) for patients treated with DES vs bare-metal stents. ST is a multifactorial process, linked to many causes, each of which may play a different role in early, late or very-late ST. In the development of early ST procedural factors, antiplatelet response/compliance and lesion complexity are of primary importance; patient's risk factors, delayed endothelialization and healing of the arterial wall are involved in the late and very-late ST. Nowadays appropriate selection of DES candidates, technically accurate implantation procedures, and adequate instructions to the patient for increasing therapy compliance are the basis for the reduction of the risk of ST; the identification of more effective antiplatelet drugs and new-generation DES (i.e., bioabsorbable polymers or stents) are promising innovations for the future.

Myocardial rupture with left ventricle to coronary sinus communication: an unusual post-infarction mechanical complication.

We describe a rare case of post-infarction myocardial rupture leading to communication between the left ventricle and coronary sinus, which eventually led to a left-to-right shunt. The observation was made in an elderly woman with subacute infero-posterior myocardial infarction. Diagnosis was initially made by transthoracic echocardiography (elicited by the finding of high-velocity flow within a dilated coronary sinus), and was confirmed in greater detail at cardiac magnetic resonance. This description adds to the list of known post-infarction mechanical complications. The finding of high-velocity flow within the coronary sinus after myocardial infarction suggests the possibility of myocardial rupture leading to left ventricle to coronary sinus communication; an unusual but potentially treatable complication.

Long-term clinical and angiographic outcome of patients with occlusive in-stent restenosis treated with (32P) beta-brachytherapy.

The objective of this study was to determine the safety and efficacy of (32)P beta-brachytherapy in totally occlusive in-stent restenosis (ISR). Patients with occlusive ISR were generally excluded from the randomized clinical trials on intracoronary brachytherapy (utilizing either gamma- or beta-sources) that have shown reductions in restenosis rate and need for revascularization procedures. We analyzed short- and long-term effects of (32)P beta-brachytherapy (20 Gy) in 27 patients (28 lesions) with occlusive ISR and 84 (99 lesions) patients with nonocclusive high-risk ISR. The primary outcome measure was frequency of in-lesion angiographic binary restenosis at 7 months. Secondary endpoints were rates of major adverse cardiac events (MACE), target vessel revascularization (TVR), clinically driven TVR, and target lesion revascularization (TLR). (32)P beta-brachytherapy was feasible and safe and provided similar postprocedural angiographic results in the two clinically comparable groups. However, the 7-month binary restenosis rate was higher in the occlusive group, as were the MACE and late total occlusion rates. Multivariate logistic analysis of the overall population indicated occlusive pattern to be the only independent predictor of angiographic restenosis. In both groups, recurrent lesions most often showed a focal pattern with significant reduction of length. Although safe and effective in high-risk ISR, (32)P brachytherapy at 20 Gy does not appear to be sufficient to avoid long-term restenosis in patients with occlusive lesions. Further studies should determine the most suitable source and dosage of brachytherapy for patients with occlusive ISR.

Predictors of 32P beta brachytherapy failure in patients with high-risk in-stent restenosis.

BACKGROUND: The effectiveness of coronary radiation therapy for the treatment of in-stent restenosis (ISR) has been established in several randomized clinical trials. The efficacy of this treatment in the general population is less well established. METHODS AND MATERIALS: We report our experience in 118 consecutive patients with nonselected high-risk ISR who had undergone successful percutaneous coronary intervention and brachytherapy with (32)P beta-irradiation and who were prospectively enrolled in a quantitative angiographic and clinical follow-up protocol at 7 months after the index procedure. The aim of this study was to investigate the independent predictor of angiographic restenosis after (32)P brachytherapy treatment. RESULTS: Of the patients, 28.8% were diabetics. The mean lesion and mean radiated lengths were, respectively, 30.1 +/- 17.2 and 43.8 +/- 16.9 mm. The ISR pattern was diffuse in 96% of the treated lesions; in particular, 22.1% presented an occlusive pattern and 37.1% a proliferative pattern. At follow-up angiographic, restenosis and major adverse cardiac events (MACE) rates were, respectively, 20.8% and 29.6%. The univariate predictors of angiographic restenosis were procedural geographic miss, pattern IV ISR, manual pullback maneuver of the radiation source, preprocedural lesion percentage stenosis and preprocedural lesion MLD. At logistic regression analysis, only geographic miss and pattern IV ISR were independent predictors of post intracoronary radiation therapy (IRT) angiographic restenosis. CONCLUSION: These data indicate that 7-month angiographic restenosis after (32)P IRT in complex patients with ISR is not a frequent event and is predicted mainly by an occlusive lesion at baseline and by procedural geographical miss.