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.

Reproducibility of an artificial intelligence optical coherence tomography software for tissue characterization: Implications for the design of longitudinal studies.

BACKGROUND: To assess the reproducibility of coronary tissue characterization by an Artificial Intelligence Optical Coherence Tomography software (OctPlus, Shanghai Pulse Medical Imaging Technology Inc.). METHODS: 74 patients presenting with multivessel ST-segment elevation myocardial infarction (STEMI) underwent optical coherence tomography (OCT) of the infarct-related artery at the end of primary percutaneous coronary intervention (PPCI) and during staged PCI (SPCI) within 7 days thereafter in the MATRIX (Minimizing Adverse Hemorrhagic Events by Transradial Access Site and angioX) Treatment-Duration study (ClinicalTrials.gov, NCT01433627). OCT films were run through the OctPlus software. The same region of interest between either side of the stent and the first branch was identified on OCT films for each patient at PPCI and SPCI, thus generating 94 pairs of segments. 42 pairs of segments were re-analyzed for intra-software difference. Five plaque characteristics including cholesterol crystal, fibrous tissue, calcium, lipid, and macrophage content were analyzed for various parameters (span angle, thickness, and area). RESULTS: There was no statistically significant inter-catheter (between PPCI and SPCI) or intra-software difference in the mean values of all the parameters. Inter-catheter correlation for area was best seen for calcification [intraclass correlation coefficient (ICC) 0.86], followed by fibrous tissue (ICC 0.87), lipid (ICC 0.62), and macrophage (ICC 0.43). Some of the inter-catheter relative differences for area measurements were large: calcification 9.75 %; cholesterol crystal 74.10 %; fibrous tissue 5.90 %; lipid 4.66 %; and macrophage 1.23 %. By the intra-software measurements, there was an excellent correlation (ICC > 0.9) for all tissue types. The relative differences for area measurements were: calcification 0.64 %; cholesterol crystal 5.34 %; fibrous tissue 0.19 %; lipid 1.07 %; and macrophage 0.60 %. Features of vulnerable plaque, minimum fibrous cap thickness and lipid area showed acceptable reproducibility. CONCLUSION: The present study demonstrates an overall good reproducibility of tissue characterization by the Artificial Intelligence Optical Coherence Tomography software. In future longitudinal studies, investigators may use discretion in selecting the imaging endpoints and sample size, accounting for the observed relative differences in this study.

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.

[Management of patients with myocardial ischemia/infarction with non-obstructive coronary artery disease in Italian catheterization laboratories: results of the SICI-GISE national survey promoted by the GISE Young Committee]. / Diagnosi e trattamento dei pazienti affetti da ischemia/infarto miocardico in assenza di coronaropatia ostruttiva nei laboratori di emodinamica italiani: risultati dell'indagine nazionale SICI-GISE promossa dal Comitato GISE Young.

BACKGROUND: Myocardial ischemia (INOCA) and acute myocardial infarction with non-obstructive coronary artery disease (MINOCA) represent emerging entities in the landscape of interventional cardiology. These conditions have heterogeneous pathophysiological mechanisms and clinical presentations, complex diagnostics, and high prognostic significance. METHODS: This survey was carried out jointly by the GISE Young Committee with the support of the SICI-GISE Society and the ICOT group with the aim of evaluating the implementation of diagnostic-therapeutic pathways in cases of suspected/confirmed INOCA and MINOCA diseases. A web-based questionnaire based on 22 questions was distributed to SICI-GISE and ICOT members. RESULTS: The survey was distributed to 1550 physicians with 104 (7%) responses. The majority of participants included interventional cardiologists (70%), in two-thirds of cases working in centers with high volume of procedures (>1000 coronary angiographies/year), who estimated a <10% annual rate of INOCA and MINOCA cases in their case load. Approximately 25% of the participants stated that they do not have the option of performing any investigation for the evaluation of patients with suspected INOCA, and less than 50% make use of advanced invasive testing for the diagnosis of MINOCA, including physiology and intravascular imaging tests. It also turns out that about 50% of respondents reported the present and future absence of dedicated diagnostic-therapeutic pathways. Even with a high perception of the clinical relevance of these diseases, about 40% of the respondents rely on clinical experience or do not deal with their management, also reporting a low prevalence of dedicated follow-up care (20% of cases followed at dedicated outpatient clinics). Factors predominantly limiting the prevalence of appropriate diagnostic and treatment pathways included the cost of materials, lack of training and expertise of practitioners, and of solid data on the long-term clinical efficacy of treatments. CONCLUSIONS: Currently, the proper management of INOCA and MINOCA disease is widely advocated but poorly implemented in clinical practice. To reverse the trend and solve the remaining controversies, it is necessary to enhance awareness, produce robust scientific data, and implement dedicated pathways for patients.

Left atrial appendage occlusion in the absence of intraprocedural product specialist monitoring: is it time to proceed alone? Results from a multicenter real-world experience.

Background: Percutaneous left atrial appendage occlusion (LAAO) presents many technical complex features, and it is often performed under the intraprocedural surveillance of a product specialist (PS). Our aim is to assess whether LAAO is equally safe and effective when performed in high-volume centers without PS support. Methods: Intraprocedural results and long-term outcome were retrospectively assessed in 247 patients who underwent LAAO without intraprocedural PS monitoring between January 2013 and January 2022 at three different hospitals. This cohort was then matched to a population who underwent LAAO with PS surveillance. The primary end point was all-cause mortality at 1 year. The secondary end point was a composite of cardiovascular mortality plus nonfatal ischemic stroke occurrence at 1 year. Results: Of the 247 study patients, procedural success was achieved in 243 patients (98.4%), with only 1 (0.4%) intraprocedural death. After matching, we did not identify any significant difference between the two groups in terms of procedural time (70 ± 19 min vs. 81 ± 30 min, p = 0.106), procedural success (98.4% vs. 96.7%, p = 0.242), and procedure-related ischemic stroke (0.8% vs. 1.2%, p = 0.653). Compared to the matched cohort, a significant higher dosage of contrast was used during procedures without specialist supervision (98 ± 19 vs. 43 ± 21, p < 0.001), but this was not associated with a higher postprocedural acute kidney injury occurrence (0.8% vs. 0.4%, p = 0.56). At 1 year, the primary and the secondary endpoints occurred in 21 (9%) and 11 (4%) of our cohort, respectively. Kaplan-Meier curves showed no significant difference in both primary (p = 0.85) and secondary (p = 0.74) endpoint occurrence according to intraprocedural PS monitoring. Conclusions: Our results show that LAAO, despite the absence of intraprocedural PS monitoring, remains a long-term safe and effective procedure, when performed in high-volume centers.

Imaging Modality to Guide Left Atrial Appendage Closure: Current Status and Future Perspectives.

Atrial fibrillation (AF) is the most common cardiac arrhythmia in adults. The left atrial appendage (LAA) is the most likely source of thrombus formation in patients with non-valvular atrial fibrillation (NVAF). Left atrial appendage closure (LAAC) represents an effective alternative to NOAC in patients with NVAF. Expert consensus documents recommend intraprocedural imaging by means of either transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE) in addition to standard fluoroscopy to guide LAAC. TEE-guided LAAC usually requires general anesthesia. The ICE technique is a "minimalist approach", without general anesthesia, but ICE imaging techniques are not yet simplified and standardize, and the ICE may result in inferior image quality compared with that of TEE. Another "minimalist approach" can be the use of ICE via the esophageal route (ICE-TEE), that jet is validated to identify the presence of LAA thrombi in patients and to perform other procedures. In our cath laboratory ICE-TEE to guide LAAC is used in some complex patients. Indeed, our single center experience suggests that ICE-TEE could be a good alternative imaging technique to guide LAAC procedure without general anesthesia.

Intracardiac echocardiography probe via oesophageal to guide percutaneous left atrial appendage closure procedure: a case series.

Background: Left atrial appendage closure (LAAC) can be an alternative to oral anticoagulant therapy in patients with non-valvular atrial fibrillation, characterized by high risk of stroke (CHA2D2VASC ≥ two for men and CHA2D2VA2SC ≥ three for women) and high risk of bleeding (HASBLED = 3). Case summary: We describe three case reports in which an intracardiac echocardiography probe was used via the oesophageal route as an alternative to traditional transoesophageal echocardiography (TEE) or ICE methods to guide LAAC. Guiding the procedure via conventional TEE, even if feasible, could be difficult in these patients due to different causes: one patient was affected by Brugada syndrome while the other two patients reported oropharyngeal abnormalities. For these reasons, we performed an alternative use of the ICE probe to guide the entire LAAC procedure. Discussion: Currently, LAAC is performed using intracardiac or transoesophageal echocardiography. This alternative use of ICE probe via oesophageal (ICE-TEE) is reported in previous studies that describe the feasibility of this technique both in excluding the presence of thrombus in left atrial appendage before cardioversion and in guiding percutaneous foramen ovale closure. Therefore, the ICE probe has been used as an intraoperative transoesophageal echocardiographic probe to repair congenital heart disease in infants or children with oropharyngeal abnormalities.This case series reports the first use of ICE-TEE to guide the entire LAAC procedure, guaranteeing the visualization of all echocardiographic views needed to perform it. The present case series highlights the potential of ICE-TEE to safely perform both pre-procedural and intraoperative evaluations in LAAC procedure.

Periprocedural outcome in patients undergoing left atrial appendage occlusion with the Watchman FLX device: The ITALIAN-FLX registry.

Introduction: The Watchman FLX is a novel device for transcatheter left atrial appendage occlusion (LAAO) specifically designed to improve procedural performance in more complex anatomies with a better safety profile. Recently, small prospective non-randomized studies have shown good procedural success and safety compared with previous experiences. Results from large multicenter registries are needed to confirm the safety and efficacy of the Watchman FLX device in a real-world setting. Methods: Italian FLX registry is a retrospective, non-randomized, multicentric study across 25 investigational centers in Italy including consecutive patients undergoing LAAO with the Watchman FLX between March 2019 and September 2021 (N = 772). The primary efficacy outcome was the technical success of the LAAO procedure (peri-device flow ≤ 5 mm) as assessed by intra-procedural imaging. The peri-procedural safety outcome was defined as the occurrence of one of the following events within 7 days after the procedure or by hospital discharge: death, stroke, transient ischemic attack, major extracranial bleeding (BARC type 3 or 5), pericardial effusion with tamponade or device embolization. Results: A total of 772 patients were enrolled. The mean age was 76 ± 8 with a mean CHA2DS2-VASc score of 4.1 ± 1.4 and a mean HAS-BLED score of 3.7 ± 1.1. Technical success was achieved in 772 (100%) patients with the first device implanted in 760 (98.4%) patients. A peri-procedural safety outcome event occurred in 21 patients (2.7%) with major extracranial bleeding being the most common (1.7%). No device embolization occurred. At discharge 459 patients (59.4%) were treated with dual antiplatelet therapy (DAPT). Conclusions: The Italian FLX registry represents the largest multicenter retrospective real-world study reporting periprocedural outcome of LAAO with the Watchman FLX device, resulting in a procedural success rate of 100% and a low incidence of peri-procedural major adverse events (2.7%).

[SICI-GISE/SICOA Consensus document: Clinical follow-up of patients after acute coronary syndrome or percutaneous coronary intervention]. / Documento di consenso SICI-GISE/SICOA: La gestione del follow-up del paziente dopo sindrome coronarica acuta e/o angioplastica coronarica.

In the last decades, advances in percutaneous coronary intervention (PCI) strategies have significantly reduced the risk of procedural complications and in-hospital mortality of patients with acute coronary syndromes (ACS), thus increasing the population of stable post-ACS patients. This novel epidemiological scenario emphasizes the importance of implementing secondary preventive and follow-up strategies. The follow-up of patients after ACS or elective PCI should be based on common pathways and on the close collaboration between hospital cardiologists and primary care physicians. However, the follow-up strategies of these patients are still poorly standardized. This SICI-GISE/SICOA consensus document was conceived as a proposal for the long-term management of post-ACS or post-PCI patients based on their individual residual risk of cardiovascular adverse events. We defined five patient risk classes and five follow-up strategies including medical visits and examinations according to a specific time schedule. We also provided a short guidance for the selection of the appropriate imaging technique for the assessment of left ventricular ejection fraction and of non-invasive anatomical or functional tests for the detection of obstructive coronary artery disease. Physical and pharmacological stress echocardiography was identified as the first-line imaging technique in most of cases, while cardiovascular magnetic resonance should be preferred when an accurate evaluation of left ventricular ejection fraction is needed. The standardization of the follow-up pathways of patients with a history of ACS or elective PCI, shared between hospital doctors and primary care physicians, could result in a more cost-effective use of resources and potentially improve patient's long-term outcome.

[Right heart catheterization in Italian catheterization laboratories: results of the SICI-GISE national survey promoted by the GISE Young Committee]. / Il cateterismo cardiaco destro nei laboratori di emodinamica italiani: risultati dell'indagine nazionale SICI-GISE promossa dal Comitato GISE Young.

BACKGROUND: Over the past decades, the improvements in the diagnostic power and availability of non-invasive cardiac imaging techniques have led to a decline of right heart catheterization (RHC) performance. However, RHC remains the gold standard for diagnosing pulmonary hypertension and an essential tool for the evaluation of patient candidacy to heart transplantation. METHODS: This survey was carried out jointly by the Young Committee of GISE, with the support of the SICI-GISE Society, and the ICOT group, with the aim of evaluating how the interventional cardiology community perform RHC. A web-based questionnaire based on 20 questions was distributed to SICI-GISE members. RESULTS: The survey was distributed to 1550 physicians with 174 (11%) responses. Most centers perform few procedures per year (<10 RHC/year) and a dedicated cardiologist is usually lacking. Patients were frequently admitted as ordinary hospitalization regimen and the most frequent indication for RHC was the hemodynamic assessment of pulmonary hypertension, followed by diagnostics of valvular diseases and advanced heart failure/heart transplantation. Indeed, the majority of participants (86%) are involved in transcatheter procedures for structural heart disease. The average time taken to perform the RHC was approximately 30-60 min. The femoral access (60%) was the most frequently used, usually by an echo-guided approach. Two-thirds of participants discontinued oral anticoagulant therapy before RHC. Only 27% of centers assess wedge position from an integrated analysis. Furthermore, the edge pressure is detected in the end-diastolic cardiac phase in half cases and in the end-expiratory phase in only 31%. The most commonly used method for cardiac output calculation was the indirect Fick method (58%). CONCLUSIONS: Guidance on the best practice for performing RHC is currently lacking. A more precise standardization of this demanding procedure is warranted.

Dual Antiplatelet Therapy with Parenteral P2Y12 Inhibitors: Rationale, Evidence, and Future Directions.

Dual antiplatelet therapy (DAPT), consisting of the combination of aspirin and an inhibitor of the platelet P2Y12 receptor for ADP, remains among the most investigated treatments in cardiovascular medicine. While a substantial amount of research initially stemmed from the observations of late and very late stent thrombosis events in the first-generation drug-eluting stent (DES) era, DAPT has been recently transitioning from a purely stent-related to a more systemic secondary prevention strategy. Oral and parenteral platelet P2Y12 inhibitors are currently available for clinical use. The latter have been shown to be extremely suitable in drug-naïve patients with acute coronary syndrome (ACS), mainly because oral P2Y12 inhibitors are associated with delayed efficacy in patients with STEMI and because pre-treatment with P2Y12 inhibitors is discouraged in NSTE-ACS, and in patients with recent DES implantation and in need of urgent cardiac and non-cardiac surgery. More definitive evidence is needed, however, about optimal switching strategies between parenteral and oral P2Y12 inhibitors and about newer potent subcutaneous agents that are being developed for the pre-hospital setting.

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.

[Percutaneous transcatheter treatment of pulmonary embolism: results of the SICI-GISE national survey promoted by the GISE-Young Committee]. / Trattamento percutaneo transcatetere dell'embolia polmonare: risultati della survey nazionale SICI-GISE promossa dal Comitato GISE Young.

BACKGROUND: Pulmonary embolism (PE) represents the third leading acute cardiovascular syndrome in the world and it is burdened with high mortality and morbidity rates. Percutaneous or catheter-based treatments of high- and intermediate-risk patients have garnered interest because of the limitations of both systemic thrombolysis and anticoagulation strategies. However, data on these techniques are heterogeneous and limited to small non-randomized evidences. METHODS: This survey was jointly performed by the GISE Young Committee with the support of the SICI-GISE Society and ICOT group with the aim of evaluating the view of the cardiology community on interventional therapies for PE. A web-based questionnaire based on 19 questions was distributed to SICI-GISE and ICOT members. RESULTS: The survey was distributed to 1550 physicians with 220 (14%) responses, 65% from North Italy. Multidisciplinary diagnostic and therapeutic pathways for patients with PE were not available in most centers (56%), and transcatheter treatment was available in 55% of centers, most of them at low volume (<5 percutaneous treatments/year). Among the devices used, mechanical thrombectomy was the predominant one (62%) in the absence of significant differences in the availability of devices within the three Italian geographic macro-areas. Respondents recognize the theoretical benefits of percutaneous treatment of PE, including: improving a prompt hemodynamic stabilization and respiratory exchange (89%) in high-risk patients, avoiding hemodynamic deterioration (39%) and right ventricular dysfunction (51%) in intermediate-risk patients, and reducing hemorrhagic complications related to systemic thrombolysis (36%). According to participants' judgement, the main factors limiting the use of percutaneous transcatheter treatment of PE in clinical practice are the lack of specific operator training (60%), lack of solid clinical data to support it (39%), difficult patient selection (34%), high costs (30%), and risk of procedural complications (26%). CONCLUSIONS: Currently, transcatheter treatment of PE appears to be widely supported but poorly used in clinical practice. Solid evidences are needed regarding the safety and efficacy profile of the different available devices, the identification of patient selection criteria, alongside the enhancement of the availability of techniques and technologies.

Use of cangrelor in patients with acute coronary syndromes undergoing percutaneous coronary intervention: Study design and interim analysis of the ARCANGELO study.

BACKGROUND: The itAlian pRospective Study on CANGrELOr (ARCANGELO) was aimed to assess the safety of using cangrelor during percutaneous coronary intervention (PCI) in patients with acute coronary syndromes (ACS) in the daily practice. HYPOTHESIS: The safety of cangrelor after the transition to oral P2Y12 inhibitors was evaluated as the incidence of bleeding outcomes in the 30 days following PCI according to postauthorization safety study guidelines. METHODS: Adults with ACS who were treated with cangrelor in one of the 28 centers involved in the study. Patients who consented to participate were followed in the 30 days following their PCI. Bleedings (Bleeding Academic Research Consortium [BARC] classification), major adverse cardiac events (MACEs), and adverse events were recorded. The interim results at two-thirds of the enrollment period are presented. RESULTS: A total of 17 bleedings were observed in the 320 patients who completed the study at this stage. All bleedings were classified as BARC Type 1-2, except for one case of Type 3a (vessel puncture site hematoma). Four patients experienced MACEs (2 acute myocardial infarctions, 1 sudden cardiac death, 1 noncardiovascular death due to respiratory distress, and multiorgan failure). None of the bleedings was rated as related to cangrelor. CONCLUSIONS: The interim results of the ARCANGELO study provide a preliminary confirmation that the use of cangrelor on patients with ACS undergoing PCI is not associated with severe bleedings.

Real-world experience with the new Watchman FLX device: Data from two high-volume Sicilian centers. The FLX-iEST registry.

INTRODUCTION: The Watchman-FLX left atrial appendage closure (LAAC) device presents innovative features: higher conformability, reduced length, closed distal "flex-ball" during deployment, and flattened surface. We report our real-world experience with the Watchman-FLX device in two centers with consolidated LAAC expertise. METHODS: We enrolled 200 consecutive Watchman-FLX patients (2019-2021) in a nonrandomized double-center registry; procedural data and follow-up for midterm clinical outcomes were collected. A control group of 100 patients treated with first-generation Watchman (2.5) was included. RESULTS: According to mean CHAD2 DS2 -VASc (5 ± 1.40) and HAS-BLED (3.8 ± 1.01) scores, the population included in this study was at high risk: 29% had a previous stroke and 56.5% a bleeding event. Main LAAC indications were symptomatic hemorrhage (39.5%), need for triple antithrombotic therapy (39%), gastrointestinal bleeding (32%), and oral anticoagulation intolerance (18%). Transesophageal echocardiography guidance was followed in 93% of cases (48% in general anesthesia and 45% under conscious sedation). Repositioning an FLX device was required in 20% of cases and no complication occurred. In 96% of patients, the first selected device was delivered, while in 4% a device size change was required after the first choice (7% with Watchman 2.5). Peridevice leaks (<5 mm) were found postimplant in two cases (1%). Overall, the procedural success rate was 99.5%. One patient's procedure was unsuccessful (0.5%), due to left atrial appendage (LAA) anatomy; differently, the mean failure rate with Watchman 2.5 was 2%. No device embolization was reported. Complications (8.5%) were mainly related to the access site (3%); major bleedings (1%), and in-hospital death (0.5%) rarely occurred. After a follow-up of 272 ± 173 days, 2.3% of cases experienced a non-device-related stroke and 0.6% fatal bleeding. CONCLUSION: Our registry showed a high procedural success rate of the Watchman-FLX in a high-risk population. According to our experience, the main advantages include easy implanting and repositioning, absence of embolization, good LAA sealing, and low rate of complications in the follow-up period.

SICI-GISE Position Document on the Use of the Magmaris Resorbable Magnesium Scaffold in Clinical Practice.

Bioresorbable scaffolds have emerged as a potential breakthrough for the treatment of coronary artery lesions. The need for drug release and plaque scaffolding is temporary, and leaving a permanent stent once the process of plaque recoil and vessel healing has ended might be superfluous or even deleterious exposing the patient to the risk of very late thrombosis, eliminating vessel reactivity, impairing non-invasive imaging and precluding possible future surgical revascularization. This long-term potential limitation of permanent bare metal stents might be overcome by using a resorbable scaffold. The metallic and antithrombotic properties make the resorbable magnesium scaffold an appealing technology for the treatment of coronary artery lesions. Notwithstanding this, its mechanical properties substantially differ from those of conventional bare metal stents, and previous experience using polymer-based scaffolds has shown that a standardized implantation technique and optimal patient and lesion selection are key factors for a successful implantation. A panel of expert cardiologists gathered to find a consensus on the best practices for Magmaris implantation in a selected patient population and to discuss the rationale for new potential future indications.

[Percutaneous transcatheter treatment of hypertension and heart failure: results of the SICI-GISE national survey promoted by the GISE Young Committee]. / Trattamento transcatetere dell'ipertensione arteriosa e dello scompenso cardiaco: risultati della survey nazionale SICI-GISE promossa dal Comitato GISE Young.

BACKGROUND: During the last decade, thanks to contemporary evidence and technological improvements, the role of interventional cardiology in the field of cardiac conditions that are mainly treated conservatively has grown a lot. In such scenario, drug-resistant arterial hypertension and heart failure (HF) have a significant role, considering the huge number of involved patients and their impact on mortality and quality of life. METHODS: This survey was jointly performed by the GISE Young Committee with the support of the SICI-GISE Society and the ICOT group with the aim of evaluating the view of the cardiology community on interventional therapies for arterial hypertension and HF. A web-based questionnaire based on 22 questions was distributed online to SICI-GISE members. RESULTS: The survey was distributed to 1550 physicians with 156 (10%) responses, 58% of whom was under 35 years of age. Renal denervation was available in 49% of Centers, its principal indication was the evidence of severe adverse reactions to anti-hypertensive drugs (80%). Most participants agreed that, compared to past years, there is more understanding of anatomical characteristics and improvement of devices, thus increasing procedural safety; however, main limitations were: appropriate patients' selection criteria (45%), lack of robust evidence (41%) and regulatory (36%) and economical (33%) factors. In the field of HF, this survey enlightened a wide availability of conventional therapies (i.e. mechanical circulatory support, defibrillators, resynchronization) in Italy; on the other side, there is limited availability of innovative devices (i.e. atrial decompression systems, transcatheter left ventricular reshaping). Many participants expressed enthusiastic attitude in this new field, with a look for the need of further evidence in terms of safety and efficacy. Finally, in the treatment of both acute and chronic HF, many participants expressed a problem of limited patient access to advanced therapies, mainly associated with suboptimal networking among institutions. CONCLUSIONS: Device-based therapies for arterial hypertension and HF represent a promising option for selected patients; this survey highlights the importance of achieving good quality evidence in both fields, with the goal of proper identification of defined criteria for patients' selection and improvement of procedural and long-term safety and efficacy.

Ultra-Short Term Evaluation of Coronary Vessel Wall Changes in Reference Segments Adjacent to Culprit Lesions in ST-Segment Elevation Myocardial Infarction.

BACKGROUND: Culprit lesions of ST-segment elevation myocardial infarction (STEMI) patients are friable, soft, and prone to disruption during primary percutaneous coronary intervention (pPCI). The presence of dissections in reference vessel segments (RVSs), adjacent to stented culprit lesions, and dynamic luminal changes in proximal or distal RVSs have not yet been investigated. We therefore sought to assess the healing patterns of edge dissections and the changes of lumen area at RVSs within 1 week post stent implantation in patients with STEMI. METHODS: In the MATRIX trial (ClinicalTrials.gov NCT01433627), optical coherence tomography (OCT) was performed at the end of pPCI and within 1 week during staged PCI. The RVS dissection was defined as: type 1 = flap; type 2 = cavity; type 3 = double barrel; and type 4 = fissure. We compared separately the fate of residual dissection and luminal area/dimension by OCT in the target vessel between pPCI and staged PCI, including 1-year clinical outcomes. RESULTS: Out of 151 patients, 46 patients had dissections in 50 RVSs and did not experience worse clinical outcome. Dissections were 44% type 1, 28% type 2, 12% type 3, and 16% type 4. Overall, 18% of the dissections healed. The mean lumen area of the RVS enlarged in 82 patients (59%) from pPCI to staged PCI. Compared with the proximal RVS, there was a significant increase in the lumen diameter at the distal RVS (0.06 ± 0.25 mm vs -0.01 ± 0.21 mm; P=.01). CONCLUSION: Dissections occur frequently after pPCI. One-fifth of them heal within 1 week and do not seem to negatively impact clinical outcomes. Distal RVS lumen area increased compared with proximal RVS, likely reflecting a different vasoconstriction pattern over time.

The "RotaTripsy Plus" Approach in a Heavily Calcified Coronary Stenosis.

Percutaneous treatment of heavily calcified coronary stenoses is one the most demanding setting, due to the high risk of acute and long-term complications. Various dedicated devices are currently available and their combined use can be an option in these high-risk procedures. We hereby report a successful case of several combined debulking technologies for the treatment of a long, highly calcified coronary lesion.

A Prospective, observational, Italian multi-center registry of self-aPposing® cOronary Stents in patients presenting with ST-segment Elevation Myocardial InfarcTION: The iPOSITION registry.

BACKGROUND: Primary percutaneous coronary intervention (pPCI) in ST-segment elevation myocardial infarction (STEMI) can be challenging for high thrombus burden and catecholamine-induced vasoconstriction. The Xposition-S stent was designed to prevent stent undersizing and minimize strut malapposition. We evaluated 1-year clinical outcomes of a nitinol, self-apposing®, sirolimus-eluting stent, pre-mounted on a novel balloon delivery system, in de novo lesions of patients presenting with STEMI undergoing pPCI. METHODS: The iPOSITION is a prospective, multicenter, post-market, observational study. The primary endpoint, target lesion failure (TLF), was defined as the composite of cardiac death, recurrent target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR). RESULTS: The study enrolled 247 STEMI patients from 7 Italian centers. Both device and procedural success occurred in 99.2% of patients, without any death, TV-MI, TLR, or stent thrombosis during the hospital stay and at 30-day follow-up. At 1 year, TLF occurred in 2.6%, cardiac death occurred in 1.7%, TV-MI occurred in 0.4%, and TLR in 0.4% of patients. The 1-year stent thrombosis rate was 0.4%. CONCLUSIONS: The use of an X-position S self-apposing® stent is feasible in STEMI pPCI, with excellent post-procedural results and 1-year outcomes.