Acute and long-term results of percutaneous coronary intervention of bifurcation lesions with the dedicated Bioss Lim C stent: the Italian BIfurcation Observational Spontaneous Study (IBIOSS).

BACKGROUND: Percutaneous coronary intervention (PCI) for bifurcation lesions still represents a clinical challenge. The Bioss Lim C is a dedicated device for bifurcation lesions, features a tapered shape and large cells, and thus appears as a promising adjunct to the current interventional cardiologists' armamentarium. We aimed at conducting a prospective multicenter study focusing on early and long-term results after Bioss Lim C implantation for true coronary bifurcation lesions. METHODS: Patients with true bifurcation lesions in whom Bioss Lim C implantation was attempted were enrolled in four Italian centers. An explicit bifurcation management approach was recommended, leaving however the choice between one- vs. two-stent strategies at operator's discretion. Acute and long-term results were systematically appraised, focusing on an acute composite of complex side branch (SB) rewiring, SB pinching, or SB occlusion (primary efficacy endpoint), as well as major adverse events (MACE, i.e. death, myocardial infarction [MI], or target vessel revascularization [TVR]), individual components of MACE, and stent thrombosis. RESULTS: A total of 207 patients were included, with age of 67.3±10.8 years, and 40 (19.3%) women. The target lesion was located in the left main in 48 (23.2%) patients, whereas proximal reference vessel diameter was 3.69±0.48 mm, and lesion length 20.3±3.4 mm. According to the Medina classification, most patients (60 [30.9%]) had 1-1-1 lesions. Drug-eluting stent implantation in the SB was carried out in 19 (9.3%) subjects, and kissing balloon inflation was used in 67 (32.5%). The primary efficacy endpoint occurred in 27 (13.0%), with side branch (SB) occlusion in two (1.0%), SB pinching in 23 (11.1%), and complex SB rewiring in six (2.9%), and was most frequent in patients with lower body mass index or dyslipidemia. After 24.1±19.5 months, MACE were adjudicated in 23 (11.1%) subjects, with death in 10 (4.8%), MI in six (2.9%), and TVR in seven (3.4%), as well as stent thrombosis in one (0.5%). CONCLUSIONS: This study supports a wider adoption of the Bioss Lim C dedicated bifurcation device, thanks to the favorable acute results as well as long-term clinical outcomes, as well as its versatility for the stenting strategy provisionally or eventually adopted by operators.

Intra-Cardiac versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion with a Watchman FLX Device.

This study aimed to compare the peri-procedural success and complication rate within a large registry of intra-cardiac echocardiography (ICE)- vs. transesophageal echocardiography (TEE)-guided left atrial appendage occlusion (LAAO) procedures with a Watchmann FLX device. Data from 772 LAAO procedures, performed at 26 Italian centers, were reviewed. Technical success was considered as the final implant of a Watchmann FLX device in LAA; the absence of pericardial tamponade, peri-procedural stroke and/or systemic embolism, major bleeding and device embolization during the procedure was defined as a procedural success. One-year stroke and major bleeding rates were evaluated as outcome. ICE-guided LAA occlusion was performed in 149 patients, while TEE was used in 623 patients. Baseline characteristics were similar between the ICE and TEE groups. The technical success was 100% in both groups. Procedural success was also extremely high (98.5%), and was comparable between ICE (98.7%) and TEE (98.5%). ICE was associated with a slightly longer procedural time (73 ± 31 vs. 61.9 ± 36 min, p = 0.042) and shorter hospital stay (5.3 ± 4 vs. 5.8 ± 6 days, p = 0.028) compared to the TEE group. At one year, stroke and major bleeding rates did not differ between the ICE and TEE groups. A Watchmann FLX device showed high technical and procedural success rate, and ICE guidance does not appear inferior to TEE.

Rate and nature of complications with leadless transcatheter pacemakers compared with transvenous pacemakers: results from an Italian multicentre large population analysis.

AIMS: The safety and efficacy of leadless intracardiac-permanent pacemaker (L-PM) have been demonstrated in multiple clinical trials, but data on comparisons with conventional transvenous-permanent pacemaker (T-PM) collected in a consecutive, prospective fashion are limited. The aim of this analysis was to compare the rate and the nature of device-related complications between patients undergoing L-PM vs. T-PM implantation. METHODS AND RESULTS: Prospective, multicentre, observational project enrolling consecutive patients who underwent L-PM or T-PM implantation. The rate and nature of device-related complications were analysed and compared between the two groups. Individual 1:1 propensity matching of baseline characteristics was performed. A total of 2669 (n = 665 L-PM) patients were included and followed for a median of 39 months, L-PM patients were on average older and had more co-morbidities. The risk of device-related complications at 12 months was significantly lower in the L-PM group (0.5% vs. 1.9%, P = 0.009). Propensity matching yielded 442 matched pairs. In the matched cohort, L-PM patients trended toward having a lower risk of overall device-related complications (P = 0.129), had a similar risk of early complications (≤30 days) (P = 1.000), and had a significantly lower risk of late complications (>30 days) (P = 0.031). All complications observed in L-PM group were early. Most (75.0%) of complications observed in T-PM group were lead- or pocket-related. CONCLUSION: In this analysis, the risk of device-related complications associated with L-PM implantation tended to be lower than that of T-PM. Specifically, the risk of early complications was similar in two types of PMs, while the risk of late complications was significantly lower for L-PM than T-PM.

A Multimodality Imaging for Definition and Treatment Selection of Multiple Coronary Aneurysms: A Case Report and Review of the Literature.

A 59-year-old woman, smoker, hypertensive, without a previous history of coronary artery disease referred several episodes of epigastric pain, after exercise electrocardiogram was referred to coronary angiography. It revealed extensive coronary calcification, with a suboccluded left anterior descending (LAD) and a calcified aneurysm of the right coronary artery (RCA), partially filled with thrombus. Coronary-computed tomography showed aneurysmal saccular dilatation of the proximal LAD entirely thrombosed with subocclusion, and a fusiform aneurysm in the proximal RCA, partially thrombosed. The patient was referred for surgical treatment. In our patient, congenital etiology of the aneurysms was unlikely, since the patient did not present congenital heart disease or known genetically inherited disorders. Among acquired aneurysms, the most common cause is represented by atherosclerosis. Other potential causes are connective tissue disorders, trauma, infections, iatrogenic, and Kawasaki syndrome. Usual complications include myocardial ischemia and infarction, embolism, rupture, fistulization, and thrombosis (clearly represented in our case). Current recommendations about management strategies of coronary artery aneurysms (CAAs) are focused on small case series and based on aneurysm's location and morphology, patient's characteristics, and clinical presentation. Medical treatment strategies include antiplatelet therapy or anticoagulant. Other therapeutical options are percutaneous coronary intervention (PCI) and coronary artery bypass graft. In our case, the heart team opted for surgical treatment due to the subocclusion of the proximal LAD and considering stable angina as admitting diagnosis. Moreover, the CAAs were placed in proximal segments, with a large amount of thrombus, so related with high risk for complications if PCI was performed.

Leadless transcatheter pacemaker: Indications, implantation technique and peri-procedural patient management in the Italian clinical practice.

BACKGROUND: Safety and efficacy of leadless pacemakers (L-PM) have been demonstrated in multiple clinical trials, but real-world data on patient selection, implantation technique, and peri-procedural patient management in a clinical practice setting are lacking. METHODS: Consecutive patients undergoing L-PM implantation in 14 Italian centers were followed in a prospective, multicentre, observational project. Data on baseline patient characteristics, clinical indications, implantation procedure, and peri-procedural patient management were collected. The rate and nature of device-related complications were also recorded. RESULTS: A total of 782 L-PM patients (68.4% male, 75.6 ± 12.4 years) were included in the analysis. The main patients-related reason leading to the choice of implanting a L-PM rather than a conventional PM was the high-risk of device infection (29.5% of cases). The implantation success rate was 99.2%. The median duration of the procedure was 46 min. In 90% of patients the device was implanted in the septum. Of patients on oral anticoagulant therapy (OAT) (n = 498) the implantation procedure was performed without interrupting (17.5%) or transiently interrupting OAT without heparin bridging (60.6%). During a median follow-up of 20 months major device-related complications occurred in 7 patients (0.9%): vascular access-site complications in 3 patients, device malfunction in 2 patients, pericardial effusion/cardiac tamponade in one patient, device migration in one patient. CONCLUSIONS: In the real world setting of Italian clinical practice L-PM is often reserved for patients at high-risk of infection. The implantation success rate was very high and the risk of major complications was low. Peri-procedural management of OAT was consistent with available scientific evidence.

Performance of transcatheter pacing system use in relation to patients' age.

PURPOSE: Real-world safety data on the use of transcatheter pacing systems particularly in very elderly patients is still limited. The aim of this analysis was to investigate the effect of age on the safety and efficacy of leadless pacemaker implant. METHODS: From May 2016 through July 2019, 577 patients were implanted with a leadless single-chamber pacemaker according to current pacing indication in 15 Italian cardiologic centers. The population was divided into age quartiles for evaluation, including (1) < 70 years, (2) 70-77 years, (3) 78-83 years, and (4) ≥ 83 years. Procedural data, complications, and electrical parameters were collected at baseline and during the follow-up. RESULTS: Procedural-related complication occurrence was very low (< 1.0%) and similar in the four subgroups according to age even if the older patients were more frail. No cardiac tamponade was reported. Among the groups, no difference was observed in procedural time, fluoroscopy time duration, and electrical parameters (mean pacing impedance: 750 ± 192 and 599 ± 156, mean pacing threshold: 0.7 ± 0.5 and 0.7 ± 0.6, and mean right ventricular sensing 10.7 ± 6.1 and 11.5 ± 4.8 at implant and last follow-up, respectively). CONCLUSIONS: The reported data demonstrated a high degree of safety during leadless implant across all patient ages. Procedural complications and device electrical measurements were similar among the different ages.

Home delivery of the communicator for remote monitoring of cardiac implantable devices: A multicenter experience during the covid-19 lockdown.

BACKGROUND: During the COVID-19 pandemic in-person visits for patients with cardiac implantable electronic devices should be replaced by remote monitoring (RM), in order to prevent viral transmission. A direct home-delivery service of the RM communicator has been implemented at 49 Italian arrhythmia centers. METHODS: According to individual patient preference or the organizational decision of the center, patients were assigned to the home-delivery group or the standard in-clinic delivery group. In the former case, patients received telephone training on the activation process and use of the communicator. In June 2020, the centers were asked to reply to an ad hoc questionnaire to describe and evaluate their experience in the previous 3 months. RESULTS: RM was activated in 1324 patients: 821 (62%) received the communicator at home and the communicator was activated remotely. Activation required one additional call in 49% of cases, and the median time needed to complete the activation process was 15 min [25th-75th percentile: 10-20]. 753 (92%) patients were able to complete the correct activation of the system. At the time when the questionnaire was completed, 743 (90%) communicators were regularly transmitting data. The service was generally deemed useful (96% of respondents) in facilitating the activation of RM during the COVID-19 pandemic and possibly beyond. CONCLUSIONS: Home delivery of the communicator proved to be a successful approach to system activation, and received positive feedback from clinicians. The increased use of a RM protocol will reduce risks for both providers and patients, while maintaining high-quality care.

Percutaneous treatments of acute myocardial infarction and major stroke: Two parallel roads.

Neurological and cardiovascular ischemic diseases represent the main causes of morbidity and mortality in the world. Physiopathological mechanisms present several similarities, based on "thromboembolic" events, as well as the pharmacological and percutaneous treatment options. We report a case of contemporary presentation of acute coronary and cerebral syndromes, successfully managed with a combined percutaneous intervention driven by the emergency setting. Whereas invasive revascularization represents nowadays the "gold standard" therapy for acute coronary syndromes, catheter-based treatment of acute stroke is not yet widespread and still under debate.

Available oral lipid-lowering agents could bring most high-risk patients to target: an estimate based on the Dyslipidemia International Study II-Italy.

AIMS: The analysis evaluated the contemporary percentage of patients with established coronary heart disease (CHD) reaching the European guidelines recommended LDL-cholesterol (LDL-C) levels of less than 70 mg/dl and the threshold required for proprotein convertase subtlisin/kexin type 9 reimbursement in Italy (100 mg/dl). It also assessed how these percentages would change in case of diffuse use of ezetimibe. METHODS: The Dyslipidemia International Study II enrolled CHD patients aged at least 18 either on lipid-lowering therapy (LLT) for at least 3 months or not on LLT at the time of the lipid profile. Distribution of LLTs and LDL-C target attainment were assessed. Multivariate logistic regression evaluated predictors of LDL-C target attainment. A 24% LDL-C lowering was modeled in patients not taking ezetimibe to assess its potential effects. RESULTS: Among 676 Italian CHD patients enrolled, LDL-C concentrations were lower among the 631 patients (93.3%) who were on LLT (82 versus 118 mg/dl; P < 0.001). The LDL-C target was attained by 35.4% of patients. Statin dose (median atorvastatin dose 40 mg/day) was the sole significant predictor of LDL-C target attainment. The simple addition of ezetimibe in the model reduced the percentage of patients more than 70 and 100 mg/dl from 64.6 to 37.9% and from 25.1 to 11.8%, respectively. CONCLUSION: Despite treatment in more than 90%, only one-third of Italian stable CHD patients attained the recommended LDL-C target. Statin dose was the sole predictor of the target achievement. The addition of ezetimibe would almost double patients at target and halve the potential candidates for reimbursement of more expensive agents such as proprotein convertase subtlisin/kexin type 9 inhibitors.

Classification for carotid artery stenting complications: manifestation, management, and prevention.

Carotid artery stenting is a rapidly evolving method for treating carotid artery disease. Various intraprocedural and postprocedural complications have been reported in the literature. However, the absence of a unified classification scheme for these complications makes it difficult, if not impossible, to study their precise incidence, predictors, and management. The aim of this article is to propose the first joint classification of periprocedural complications, to analyze their incidence and etiology, and suggest possible ways to manage and prevent them. This classification is intended to be used as a common platform for prompt recognition, evaluation, treatment, and universal study of the complications during carotid stenting procedures. For this purpose, the opinions of the major experts on carotid interventions worldwide were merged with all the available information reported in the English-language literature to present as accurately as possible the management and prevention of carotid stenting complications according to this proposed classification.

[Diagnosis and management of periprocedural complications of carotid artery stenting]. / Complicanze periprocedurali dello stenting carotideo: inquadramento diagnostico e terapeutico.

Despite the significant improvement in the materials and the techniques used during carotid artery stenting (CAS) as well as the increased operator experience during the last years, complications still occur. Up to now, neither a classification nor a common definition of the possible complications still exist. It would be crucial as a common platform for prompt recognition, evaluation, treatment and study of the complications during CAS procedures and to reduce the clinical sequelae. The aim of this article is to review the most frequent periprocedural complications, to analyze their incidence and etiology, and to suggest possible ways of management and prevention.

Coronary heart disease extension as a predictor of atherosclerotic renal artery stenosis.

BACKGROUND: Although the association of renal artery stenosis with coronary artery disease is well established, the best cutoff of diseased coronary vessels predicting atherosclerotic narrowing of renal artery remains still undefined. METHODS: In 109 consecutive patients (78/31 M/F) submitted to elective coronary angiography because of effort angina, renal angiography was also performed in the same session. We considered only renal artery stenosis > or =60% to be of clinical relevance. RESULTS: Coronary artery stenosis was present in 87 patients (80%), while significant narrowing of renal arteries was found in 42 patients (39%). On univariate analysis, the odds ratio (OR) of renal artery stenosis associated with 1 stenotic coronary vessel was 1.76 (95% confidence interval [95% CI], 1.34-2.33, p<0.001). This estimate was confirmed in a multiple logistic regression model adjusting for a series of potential confounders (OR=1.83, 95% CI, 1.34-2.48, p<0.001). On receiver operating characteristic curve analysis (area under the curve: 0.74 +/- 0.05, p<0.001), the presence of 3 diseased coronary vessels provided the best cutoff for the diagnosis of concomitant renal artery stenosis (positive predictive value: 63%; negative predictive value: 76%). CONCLUSIONS: There is a strong parallelism between the number of diseased coronary vessels and the occurrence of renal vascular disease. The presence of 3 diseased coronary vessels may corroborate the decision of performing renal angiography in patients with ischemic heart disease.

Sicilian DES Registry: prospective in-hospital and 9-month clinical and angiographic follow-up in selected high restenosis risk patients.

OBJECTIVE: This is a multicentre, open label, prospective non-randomized registry, with 9-month angiographic follow-up, conducted to evaluate the safety and effectiveness of drug-eluting stents (DES) when used in high restenosis risk patients from the real world. METHODS: From June 2004 to February 2005, a total of 1622 consecutive patients were enrolled to the Sicilian DES Registry, according to specific inclusion criteria. Both paclitaxel-eluting and sirolimus-eluting stents were used. The analysis was performed on 1472 patients because 150 patients were excluded from the study. The primary endpoint was to evaluate the rate of major adverse cardiac events (MACE) within 9 months after DES implantation. Major adverse cardiac events were defined as cardiac death, non-Q-wave or Q-wave myocardial infarction (MI) and target vessel revascularization (TVR). The secondary endpoints were procedural success, angiographic binary restenosis and stent thrombosis within 9 months post-procedure. RESULTS: Patients were more frequently male; 472 (32.1%) were diabetics, of whom 130 (27.5%) were treated with insulin. Mean ejection fraction of the left ventricle was 51.5 +/- 8.7%. Multivessel disease was found and treated in 627 patients (42.6%). A total of 2439 lesions were treated with DES. Final angiographic success was achieved in 2422 (99.3%) lesions. Procedural success was achieved in 1422 (96.6%) patients. The 9-month cumulative incidence of MACE was 7.3% with 0.8% of cardiac deaths, 0.8% non-fatal MI, 7.9% TVR. Binary restenosis was observed in 101 patients (8.3%). Stent thrombosis was documented in 11 patients (0.8%). CONCLUSIONS: Drug-eluting stents appear to be safe and associated with a low incidence of MACE at 9-month follow-up, even in patients selected for their complexity.

Carotid artery stenting in the presence of contralateral carotid occlusion: mind the hyperperfusion syndrome!

Stroke is the third cause of death in western countries and its complications lead to significant socio-economic problems related to the prolonged hospitalization and rehabilitation of patients with neurological lesions. Severe atherosclerotic lesions of the carotid artery are the main cause of stroke and transient ischemic attacks. Their incidence may reach 5-7% per year in patients with carotid artery stenosis > 70% with or without symptoms. Time-honored carotid endarterectomy is still regarded as the gold standard therapy for primary and secondary prevention of stroke. However, surgery is not free of complications and the rate of perioperative stroke ranges from 5.1 to 14.3%. A group of patients at a particularly high risk of stroke during surgical endarterectomy is represented by patients with significant carotid stenosis in the presence of an occluded contralateral artery. Indeed, carotid cross-clamping during operative surgery in the absence of an adequate collateral flow may result in a critical flow reduction during the operation and therefore increases the risk of periprocedural strokes. In the North American Symptomatic Carotid Endarterectomy (NASCET) trial, the overall risk of stroke was 5.1%, whereas it increased up to 14.3% in patients with an occluded contralateral carotid artery. Recently, carotid stenting has been increasingly used as an endovascular technique for carotid revascularization, especially after the introduction of neuroprotection devices which improved the safety of the procedure. Therefore, it may be an attractive alternative to carotid endarterectomy, especially when the surgical risk is too high. We describe the immediate and late outcomes of 3 patients treated with carotid artery stenting in the presence of contralateral carotid occlusion.

Resolution of myocardial ischemia due to coronary microcirculatory vasoconstriction in a patient with mixed angina.

Vasoconstriction of collateral vessels has been previously reported as a mechanism of spontaneous transient ischemic episodes and after the administration of ergonovine. This case report describes a 47-year-old woman with mixed angina and a right coronary artery occlusion supplied by a collateral system related to the left anterior descending artery. Angina and ECG changes at rest were present for more than 1 year and also provoked by intracoronary ergonovine which induced collateral vasoconstriction. To the best of our knowledge, this report is the first demonstration that the reopening of the right coronary artery and the disappearance of collateral vessels may definitively relieve angina and ECG changes occurring at rest, thus confirming small coronary vessel constriction as the main cause of the disease status.

[Two consecutive cases of myocardial infarction among young women in reproductive age and without risk factors]. / Due casi consecutivi di infarto miocardico in donne giovani in età fertile ed in assenza di concomitanti fattori di rischio.

Coronary artery disease does not occur in all the patients with acute myocardial infarction. Coronary artery diseases occurs in 97% of cases; in the other 3% of cases, myocardial infarction is caused by coronary spasm (40%, intracoronary thrombosis (60%) due to platelet hyperreactivity, peripartum thrombophilia or use of oral contraceptives. Myocardial infarction in young women is an infrequent event. Spontaneous coronary artery dissection is a rare cause of acute myocardial infarction that typically occurs during the peripartum period. A few cases of myocardial infarction in premenopausal women with no risk factors for coronary artery disease and normal coronary arteries have been reported. We describe 2 consecutive cases of acute myocardial infarction occurred in young, premenopausal women, without risk factors for cardiovascular diseases.

Prophylactic abciximab in elective coronary stenting: results of a randomized trial.

BACKGROUND: The use of abciximab (c7E3 Fab; ReoPro , Eli Lilly & Company, Indianapolis, Indiana) during percutaneous coronary intervention (PCI) decreases the incidence of early (30-day) and late (6-month to 1 year) adverse cardiac ischemic events. In a high-risk population, abciximab also reduced the need for target lesion revascularization. PCI of lesions with complex morphology, particularly long lesions, is associated with more complicated outcomes. The use of multiple and/or long intracoronary stents to cover long coronary lesions may lower the incidence of acute or subacute occlusion, but is still limited by a high late restenosis rate. We characterized patients undergoing elective implantation of long or multiple overlapping coronary stents and determined the impact of abciximab administration on clinical and angiographic outcomes. METHODS AND RESULTS: In a prospective, single-center randomized trial, a total of 107 patients undergoing elective implantation of long or multiple overlapping coronary stents were randomly assigned to receive either standard-dose heparin (n = 53) or abciximab plus low-dose heparin (n = 54). The use of abciximab was not associated with an increased incidence of bleeding or vascular complications compared to standard heparin regimen (3.7% versus 3.8%, respectively; p = NS). A 68% reduction in composite in-hospital cardiac events (i.e., death, myocardial infarction, urgent revascularization) was observed in the abciximab group (3.7% versus 11.5%, p = 0.1). At 6-month follow-up, a 48% reduction of target lesion revascularization (11% versus 21%; p = 0.1) and a decrease in binary angiographic restenosis were observed for abciximab-treated patients (17% versus 34%; p < 0.05). CONCLUSION: The peri-procedural use of abciximab during implantation of long or multiple overlapping coronary stents is safe and effective, as it does not increase bleeding or vascular complications compared to standard heparin anticoagulation and reduces the incidence of in-hospital adverse cardiac events; moreover, abciximab improves 6-month clinical and angiographic outcomes in such a complex setting.