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.

Long-term impact of intravascular ultrasound-guidance for percutaneous coronary intervention on unprotected left main. The IMPACTUS-LM, an observational, multicentric study.

INTRODUCTION: The potential benefit on long term outcomes of Percutaneous Coronary Intervention (PCI) on Unprotected Left Main (ULM) driven by IntraVascular UltraSound (IVUS) remains to be defined. METHODS: IMPACTUS LM-PCI is an observational, multicenter study that enrolled consecutive patients with ULM disease undergoing coronary angioplasty in 13 European high-volume centers from January 2002 to December 2015. Major Adverse Cardiovascular Events (MACEs) a composite of cardiovascular (CV) death, target vessel revascularization (TVR) and myocardial infarction (MI) were the primary endpoints, while its single components along with all cause death the secondary ones. RESULTS: 627 patients with ULM disease were enrolled, 213 patients (34%) underwent IVUS-guided PCI while 414 (66%) angioguided PCI. Patients in the two cohorts had similar prevalence of risk factors except for active smoking and clinical presentation. During a median follow-up of 7.5 years, 47 (22%) patients in the IVUS group and 211 (51%) in the angio-guided group underwent the primary endpoint (HR 0.42; 95% CI [0.31-0.58] p < 0.001). After multivariate adjustment, IVUS was significantly associated with a reduced incidence of the primary endpoint (adj HR 0.39; 95% CI [0.23-0.64], p < 0.001), mainly driven by a reduction of TVR (ad HR 0.30, 95% CI [0.15-0.62], p = 0.001) and of all-cause death (adj HR 0.47, 95% CI [0.28-0.82], p = 0.008). IVUS use, age, diabetes, side branch stenosis, DES and creatinine at admission were independent predictors of MACE. CONCLUSIONS: In patients undergoing ULM PCI, the use of IVUS was associated with a reduced risk at long-term follow-up of MACE, all-cause death and subsequent revascularization.

Percutaneous coronary interventions for aneurysmatic right coronary artery in acute coronary syndrome: RIGHTMARE registry outcomes.

BACKGROUND: The optimal strategy during percutaneous coronary intervention (PCI) of aneurysmatic right coronary artery (ARCA) remains uncertain and has never been tested in the acute setting. OBJECTIVES: To compare the in-hospital and long-term outcomes of immediate and staged PCI strategies for ARCA as culprit lesions during acute coronary syndrome (ACS). METHODS: Among 102.376 PCIs performed in 18 European centers, a total of 85 patients presenting with acute coronary syndrome undergoing ARCA PCI were finally included in the analysis. PCI strategy (stenting performed during the immediate vs staged procedure) and pharmacological approach adopted were collected. The primary outcome was procedural success (technical success without in-hospital MACE). RESULTS: The primary outcome occurred in 48.2 % of cases, with no significant differences observed between the immediate and staged PCI groups (50.9 % vs 43.3 %, p = 0.504). Patients in the staged-PCI group had a significantly higher rate of intravenous anticoagulant use (83.3 % vs 48.1 %, p = 0.002), BARC type 3 and 5 bleedings (12.9 % vs 1.9 %, p = 0.037), and longer in-hospital stay (7.40 ± 5.11 vs 9.5 ± 5.25 days, p = 0.049). After multivariate analysis, no independent predictors for procedural success were found in either group. Target lesion failure occurred in 24.1 % of cases without differences between groups at a median follow-up of three years. CONCLUSIONS: Among patients undergoing ARCA PCI in the setting of ACS, immediate or staged PCI were associated with similar in-hospital and long-term outcomes. However, staged PCI was associated with a higher risk of major bleeding events and longer length of stay compared to immediate PCI strategy.

Management of Vascular Access in the Setting of Percutaneous Mechanical Circulatory Support (pMCS): Sheaths, Vascular Access and Closure Systems.

The use of percutaneous mechanical circulatory support (pMCS), such as intra-aortic balloon pump, Impella, TandemHeart and VA-ECMO, in the setting of cardiogenic shock or in protect percutaneous coronary intervention (protect-PCI) is rapidly increasing in clinical practice. The major problem related to the use of pMCS is the management of all the device-related complications and of any vascular injury. MCS often requires large-bore access, if compared with common PCI, and for this reason the correct management of vascular access is a crucial point. The correct use of these devices in catheterization laboratories requires specific knowledge such as the correct evaluation of the vascular access performed, when possible, with advance imaging techniques in order to choose a percutaneous or a surgical approach. In addition to conventional transfemoral access, other types of access, such as transaxillary/subclavial access and the transcaval approach, have emerged over the years. These other approaches require advanced skills of the operators and a multidisciplinary team with dedicated physicians. Another important part of the management of vascular access is the closure systems used for hemostasis. Currently, two types of devices are typically used in the lab: suture-based or plug-based ones. In this review we want to describe all these aspects related to the management of vascular access in pMCS and describe, finally, a case report from our center's experience.

[Percutaneous treatment of intermediate- and high-risk pulmonary embolism: two case reports]. / Trattamento percutaneo dell'embolia polmonare a rischio intermedio e ad alto rischio: due casi clinici.

Pulmonary embolism is the third most common cause of cardiovascular emergency. Risk stratification is crucial in the clinical and therapeutic management of these patients. The latest European guidelines introduced a new classification based on short-term mortality risk stratification, dividing patients into four categories (high, intermediate-high, intermediate-low and low risk). Despite the limited evidence in this field, the percutaneous treatment of pulmonary embolism represents an option of interest; however, correct patient selection and device choice should be better investigated. In this article, we present two case reports of patients with intermediate-high-risk and high-risk pulmonary embolism treated with the EkoSonic Endovascular System (EKOS Corp., Bothell, WA, USA) and the FlowTriever System (Inari Medical, Irvine, CA, USA), respectively.

Impact of Successful Chronic Coronary Total Occlusion Recanalization on Recurrence of Ventricular Arrhythmias in Implantable Cardioverter-Defibrillator Recipients for Ischemic Cardiomyopathy (VACTO PCI Study).

BACKGROUND: Coronary chronic total occlusion lesions (CTOs) confer an increased risk of arrhythmic events among patients with ischemic cardiomyopathy (ICM) and implantable cardioverter-defibrillator (ICD) carriers, however the impact of CTO recanalization in this population remains unassessed. AIMS: Evaluate the impact of CTOs percutaneous coronary interventions (PCI) on arrhythmic events. METHODS: Patients with ICM and ICD from the VACTO I-II registries: patients with medically treated CTO (CTO-OMT group) and without CTO (no-CTO group) were compared after inverse-probability-weighting adjustment (IPWT) with a similar population of consecutive patients undergoing CTO-PCI. The primary endpoint was appropriate ICD therapy. The secondary endpoint was all-cause mortality. RESULTS: The total of 622 patients (mean age 67 ± 10 years, mean left ventricular ejection fraction 36 ± 11%) included in the analysis was composed by: CTO-PCI patients n = 113, CTO-OMT patients n = 286, no-CTO patients n = 223. In the CTO-PCI group, compared to the CTO-OMT group, 5-year Kaplan Meier estimates for appropriate ICD therapy (20.4% vs. 56.4%, IPW-adjusted HR: 0.45, 95% CI 0.29-0.71) and mortality (8.8% vs. 23%, IPW-adjusted HR: 0.43, 95% CI 0.22-0.85) were lower, driven by infarct related artery CTO (IRA-CTO) PCI, while similar to those occurring in the no-CTO group. CONCLUSIONS: In this large population, those with CTO receiving PCI had lower arrhythmic event rates and lower mortality compared to the CTO-OMT group, while showing an event rate similar to no-CTO patients. Sensitivity analyses suggest that the beneficial effect on the arrhythmic outcome was driven by IRA-CTO revascularization. CLASSIFICATION: Chronic total occlusion.

Suitability for elderly with heart disease of a QR code-based feedback of drug intake: Overcoming limitations of current medication adherence telemonitoring systems.

BACKGROUND: Current medication adherence telemonitoring systems have several limitations prompting the need for simpler, low-cost and widely applicable tools. To meet these needs, we propose a novel method consisting in sending a digital feedback of medication intake by just reading a pre-defined Quick Response (QR) code attached on the pills box. METHODS: To assess the potential clinical applicability of the proposed QR code-based task, its feasibility was tested among elderly with heart diseases. The primary endpoint was the learning success defined as a correct execution of all QR code-based digital task steps within 10 min. Study outcomes were compared between patients 65-75 years old (younger cohort) and those aged >75 years (older cohort) admitted to the Cardiology ward of a tertiary center. RESULTS: A total of 262 patients were included: 128 (48.9%) were younger and 134 (51.1%) older. Despite a baseline low smartphone use in the overall population (41.2%), patients learning success of the digital task was as high as 75.6%, with lower rates among older vs. younger (67.9% vs. 83.6%, p = 0.005). After adjustment no significant independent association between age and success in learning the QR code-based task was found. Differently, increasing age was a negative independent predictor of smartphone use. The learning time was overall small, but longer in the older group (126 ± 100 vs. 100 ± 60 s, p = 0.03). CONCLUSIONS: The QR code-based digital task was highly feasible for elderly with heart diseases suggesting its potential large-scale clinical application and encouraging the investigation of QR code-based systems for medication adherence telemonitoring.

Impact of Post-Procedural Change in Left Ventricle Systolic Function on Survival after Percutaneous Edge-to-Edge Mitral Valve Repair.

OBJECTIVES: To investigate how the changes of left ventricle ejection fraction (LVEF) between admission and discharge affected the long-term outcome in patients who underwent percutaneous edge-to-edge mitral valve repair for secondary mitral regurgitation. BACKGROUND: An acute impairment of LVEF after surgical repair of mitral regurgitation, known as afterload mismatch, has been associated with increased all-cause mortality. Afterload mismatch after percutaneous edge-to-edge mitral valve repair has been postulated to be a transient phenomenon. METHODS: This study is based on a single-center, retrospective, observational registry of patients who underwent percutaneous edge-to-edge mitral valve repair with the MitraClip (Abbot Vascular) system for the treatment of symptomatic, moderate-to-severe mitral regurgitation. We included data on 399 patients who underwent percutaneous edge-to-edge mitral valve repair for secondary mitral regurgitation. Expert echocardiographers assessed LVEF before the procedure and at discharge. The patients were divided into three groups according to the difference of periprocedural LVEF measurements: unchanged (n = 318), improved (n = 40), and decreased (n = 41) LVEF. RESULTS: The median follow-up time was 2.0 years. When adjusted for gender, NYHA class and estimated glomerular filtration rate, decreased postprocedural LVEF was associated with an increased risk of death (adjusted HR 2.05, 95% CI 1.26-3.34) and increased postprocedural LVEF with a reduced risk of death (adjusted HR 0.47, 95% CI 0.24-0.91) compared to unchanged LVEF. Conclusion: Among patients who underwent percutaneous edge-to-edge mitral valve repair, decreased postprocedural LVEF was associated with increased mortality, while improved LVEF was associated with lower mortality compared to unchanged LVEF.