Efficacy and Safety of P2Y12 monotherapy vs standard DAPT in patients undergoing percutaneous coronary intervention: meta-analysis of randomized trials.

BACKGROUND: Debates persist regarding the optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in coronary artery disease (CAD). Recent trials have introduced a novel approach involving P2Y12 inhibitor monotherapy with ticagrelor or clopidogrel, after a short DAPT. However, the effectiveness and safety of this strategy remains to be established. We aimed to perform a meta-analysis comparing monotherapy with P2Y12 inhibitors versus standard DAPT in patients undergoing PCI at 12 months. METHODS: Multiple databases were searched. Six RCTs with a total of 24877 patients were included. The primary endpoint was all-cause mortality at 12 months of follow-up. The secondary endpoints were cardiovascular mortality, myocardial infarction, probable or definite stent thrombosis, stroke events, and major bleeding. The study is registered with PROSPERO (CRD42024499529). RESULTS: Monotherapy with P2Y12 inhibitor ticagrelor significantly reduced both allcause mortality (HR 0.71, 95 CI [0.55-0.91], P = 0.007) and cardiovascular mortality (HR 0.66, 95% CI [0.49-0.89], P = 0.006) compared to standard DAPT. In contrast, clopidogrel monotherapy did not demonstrate a similar reduction. The decrease in mortality associated with ticagrelor was primarily due to a lower risk of major bleeding (HR 0.56, 95% CI [0.43-0.72], P < 0.001), while the risk of myocardial infarction (MI) remained unchanged (HR 0.90, 95% CI [0.73-1.11], P = 0.32). The risk of stroke was found to be similar across treatments. CONCLUSIONS: In comparison to standard DAPT, P2Y12 inhibitor monotherapy with ticagrelor may lead to a reduced mortality. The clinical benefits are driven by a reduction of bleeding risk without ischemic risk trade-off.

Clinical application of virtual reality in patients with cardiovascular disease: state of the art.

Virtual reality offers a multisensory experience to patients, allowing them to hear, watch, and interact in a virtual environment. Immersive virtual reality is particularly suitable for the purpose of completely isolating patients from the external environment to transport them away from the suffering related to the disease. On this state of the art, we summarize the available literature on the effectiveness of virtual reality on various physical and psychological outcomes in patients with atherosclerotic cardiovascular disease. Virtual reality has been employed in the cardiovascular field in various settings such as cardiac rehabilitation, interventional cardiology, and cardiac surgery. This technology offers promising opportunities to improve several outcomes related to cardiovascular disease, but further research is needed to entirely capture its benefits and to standardize the intervention.

Effectiveness of virtual reality on pain and anxiety in patients undergoing cardiac procedures: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Cardiac procedures often induce pain and anxiety in patients, adversely impacting recovery. Pharmachological approaches have limitations, prompting exploration of innovative digital solutions like virtual reality (VR). Although early evidence suggests a potential favourable benefit with VR, it remains unclear whether the implementation of this technology can improve pain and anxiety. We aimed to assess by a systematic review and meta-analysis the effectiveness of VR in alleviating anxiety and pain on patients undergoing cardiac procedures. METHODS: Our study adhered to the PRISMA method and was registered in PROSPERO under the code CRD42024504563. The search was carried out in the PubMed, Web of Science, Scopus, and the Cochrane Library databases in January 2024. Four randomized controlled trials were included (a total of 382 patients). Risk of bias was employed to assess the quality of individual studies, and a random-effects model was utilized to examine the overall effect. RESULTS: The results showed that VR, when compared to the standard of care, had a statistically significant impact on anxiety (SMD = -0.51, 95 % CI: -0.86 to -0.16, p = 0.004), with a heterogeneity I2 = 57 %. VR did not show a significant difference in terms of pain when compared to standard care (SMD= -0.34, 95 % CI: -0.75 to -0.07, p = 0.10). The included trials exhibited small sample sizes, substantial heterogeneity, and variations in VR technology types, lengths, and frequencies. CONCLUSIONS: VR effectively lowers anxiety levels in patients undergoing cardiac procedures, however, did not show a statistically significant difference on pain.

Long-term safety and efficacy of left atrial appendage occlusion in dialysis patients with atrial fibrillation: a multi-center, prospective, open label, observational study.

Background: The prevalence of atrial fibrillation (AF) in end stage kidney disease (ESKD) patients undergoing dialysis is high, however, the high risk of bleeding often hampers with a correct anticoagulation in ESKD patients with AF, despite high thromboembolic risk. Left atrial appendage (LAA) occlusion is a anticoagulation (OAT) for thromboembolism prevention in AF populations with high hemorrhagic risk. Methods and Results: The purpose of the study was to evaluate the efficacy and safety of LAA occlusion in a cohort of dialysis patients undergoing the procedure (LAA occlusion cohort, n = 106), in comparison with two other ESKD cohorts, one taking warfarin (Warfarin cohort, n = 114) and the other without anticoagulation therapy (No-OAT cohort, n = 148). After a median follow-up of 4 years, a Cox regression model, adjusted for possible confounding factors, showed that the hazard ratios (HRs) of thromboembolic events in the LAA occlusion cohort were 0.19 (95%CI 0.04-0.96; p = 0.045) and 0.16 (95%CI 0.04-0.66; p = 0.011) as compared with Warfarin and No-OAT cohorts, respectively. The HR of bleeding in the LAA occlusion cohort was 0.37 (95%CI 0.16-0.83; p = 0.017) compared to Warfarin cohort, while there were no significant differences between the LAA occlusion and the No-OAT cohort (HR 0.51; 95%CI 0.23-1.12; p = 0.094). Adjusted Cox regression models showed lower mortality in patients undergoing LAA occlusion as compared with both the Warfarin cohort (HR 0.60; 95%CI 0.38-0.94; p = 0.027) and no-OAT cohort (HR 0.52; 95%CI 0.34-0.78; p = 0.002). Thromboembolic events in the LAA occlusion cohort were lower than expected according to the CHA2DS2VASc score (1.7 [95%CI 0.3-3.0] vs 6.7 events per 100 person/years, p < 0.001). Conclusion: In ESKD patients with AF, LAA occlusion is safe and effective and is associated with reduced mortality compared with OAT or no therapy.

When Atrial Fibrillation Meets Cerebral Amyloid Angiopathy: Current Evidence and Strategies.

Non-valvular atrial fibrillation (AF) and cerebral amyloid angiopathy (CAA) are two common diseases in elderly populations. Despite the effectiveness of oral anticoagulant therapy in cardioembolic stroke prevention, intracranial hemorrhage represents the most serious complication of these therapies. Cerebral amyloid angiopathy is one of the main risk factors for spontaneous intracranial bleeding, and this risk is highly increased by age and concomitant antithrombotic therapies. Cerebral amyloid angiopathy can be silent for years and then manifest with clinical features simulating TIA (TIA-mimics) or stroke in AF patients, pushing clinicians to rapidly start VKAs or DOACs, thus increasing the risk of intracranial bleeding if the diagnosis of CAA was unknown. Because the cerebral amyloid angiopathy is easily diagnosed with non-contrast MRI, suspecting the disease can avoid catastrophic complications. In this review, we will provide physicians managing anticoagulant therapies with key tips to familiarize themselves with cerebral amyloid angiopathy, with a focus on the possible clinical presentations and on the diagnostic criteria.

Percutaneous Left Atrial Appendage Occlusion: What the Practising Physician Should Know.

Non-valvular AF is a common clinical condition associated with an increased risk of thromboembolic complications. As a consequence, oral anticoagulant therapy (OAT) is the cornerstone of non-valvular AF management. Despite the well-established efficacy of OAT, many patients cannot receive this preventive therapy due to bleeding or a high risk of bleeding. The fact that more than 90% of thrombi are formed in the left atrial appendage has led to the development of alternative methods to reduce the embolic risk. Left atrial appendage occlusion (LAAO) is a non-pharmacological option for preventing cardioembolic events in patients with non-valvular AF with a contraindication to OAT. The demand for LAAO procedures is growing exponentially and clinicians should consider this alternative option when managing patients with a contraindication to OAT. This review summarises the current thinking about LAAO.

SUOH 03 Guidewire for the Management of Coronary Artery Dissection: Insights from a Multicenter Registry.

Background: In the setting of coronary artery dissection, both spontaneous and iatrogenic, fixing the intimal tear, usually with stent implantation, can be extremely challenging if the distal wire position has been lost. Common complications are mainly related to the inadvertent subintimal tracking of the guidewire while attempting to gain the distal true lumen. Aims: To report the registry results of using the SUOH 0.3 guidewire for managing coronary artery dissection in a real-world multicenter setting. Methods: The study population in this retrospective, multicenter, international registry included 75 consecutive patients who underwent PCI and required an antegrade wiring of a dissected coronary artery. Results: Successful use of SUOH 0.3 was achieved in 69 (92%) patients. The use of a microcatheter was associated with a significantly higher rate of TIMI 3 flow at the end of the procedure (no microcatheter: n = 17, 81%; microcatheter: n = 52, 96.3%; p = 0.017). The first recanalization attempt was made with the SUOH 03 guidewire in 48 (64%) cases, and it was successful in 42 (87%). The overall PCI success rate was reported in 72 (96%) patients, with no significant differences among patients with different origins, mechanisms, and locations of dissection. Conclusions: In this setting, the SUOH 0.3 guidewire provides high procedural success without additional complex techniques.

Aging of the Arterial System.

Aging of the vascular system is associated with deep changes of the structural proprieties of the arterial wall. Arterial hypertension, diabetes mellitus, and chronic kidney disease are the major determinants for the loss of elasticity and reduced compliance of vascular wall. Arterial stiffness is a key parameter for assessing the elasticity of the arterial wall and can be easily evaluated with non-invasive methods, such as pulse wave velocity. Early assessment of vessel stiffness is critical because its alteration can precede clinical manifestation of cardiovascular disease. Although there is no specific pharmacological target for arterial stiffness, the treatment of its risk factors helps to improve the elasticity of the arterial wall.

Clinical outcomes of left atrial appendage occlusion in patients with previous intracranial or gastrointestinal bleeding: Insights from the LOGIC (Left atrial appendage Occlusion in patients with Gastrointestinal or IntraCranial bleeding) International Multicenter Registry.

AIMS: To compare outcomes of patients who underwent left atrial appendage occlusion (LAAO) for nonvalvular atrial fibrillation (NVAF) and contraindication to anticoagulants due to history of either gastrointestinal (GI) or intracranial (IC) bleeding. METHODS: Patients with NVAF that underwent LAAO for GI or IC bleeding from seven centers were included in this observational study. Baseline characteristics, procedural features, and follow-up data were collected, and compared between the two groups. The primary outcomes were incidence of ischemic and hemorrhagic events at 12-month. RESULTS: Six hundred twenty-eight patients were included, 57% with previous GI-bleeding, and 43% with previous IC-bleeding. Median CHA 2 DS 2-VASc score was 4 (interquartile range [IQRs]: 3-5) for both GI-bleeding and IC-bleeding patients, while GI-bleeding patients had a higher HAS-BLED score (4 [IQRs: 3-4] vs. 3 [IQRs]: 2-3]; p = 0.001). At 12-month follow-up, relative risk reduction for stroke was similar between the two groups. The GI-bleeding group had more hemorrhagic events compared to IC-bleeding group (any bleeding 8.4% vs. 3.2%; p = 0.012; major bleeding BARC 3-5: 4.3% vs. 1.8; p = 0.010). At multivariate analysis history of GI bleeding was an independent predictor of hemorrhagic events (adjusted HR: 2.39, 95% confidence interval: 1.02-5.63; p = 0.047). CONCLUSIONS: Outcomes after LAAO may be affected by the different indications for the procedure. In our study, GI-bleeding and IC-bleeding as indication to LAAO differ in their baseline characteristics. LAAO confirms its efficacy in ischemic risk reduction in both groups, while GI bleeding seems to be an independent predictor of bleeding recurrence at 12 months behind the antithrombotic regimen.

Some good reasons to proceed with the occlusion of the auricle.

Atrial fibrillation (AF) is the most common arrhythmia. The most fearful complication of AF is represented by cardio-embolic stroke and 30% of ischaemic strokes are attributable to AF. The prevention of cardio-embolic risk is therefore based on oral anticoagulant therapy (OAT). Some categories of patients do not benefit from OAT. These are patients at increased bleeding risk and with varying degrees of contraindication to long-term anticoagulant therapy. On the opposite are those patients who develop an embolic event related to AF despite a well-conducted OAT. These types of patients benefit from an interventional approach, percutaneous closure of the left auricle (LAAO), aimed at eliminating what is the primary source of AF-related thrombo-embolism, precisely the left auricle. Percutaneous closure of the left auricle has proven to be an effective and safe procedure, significantly reducing the bleeding risks of patients who, after the procedure, will no longer have to take OAT. Furthermore, it has been shown to be effective in reducing cardio-embolic risk. Uncertainty still remains as to what is the optimal antithrombotic therapy after LAAO. In any case, LAAO represents a valid alternative to OAT for those patients in whom it is contraindicated or ineffective.

Stent Dislodgment and Retrieval During Percutaneous Coronary Intervention.

During PCI, stent entrapment and dislodgment in the coronary arteries is a rare but potentially fatal complication that can lead to emergent cardiac surgery. Percutaneous stent retrieval is an alternative way to solve this challenging complication while avoiding cardiac surgery.

Allergic Myocardial Infarction: An Unusual Cause of Stent Thrombosis.

Our case confirms that an allergic insult can cause an acute myocardial infarction in a stable coronary disease setting. It also suggests that type 3 Kounis syndrome must be suspected in cases of apparently unexplained "very late" stent thrombosis.

Predictors of inappropriate shock in Brugada syndrome patients with a subcutaneous implantable cardiac defibrillator.

BACKGROUND: Subcutaneous implantable cardioverter defibrillators (S-ICDs) avoid complications secondary to transvenous leads, but inappropriate shocks (ISs) are frequent. Furthermore, IS data from patients with Brugada syndrome (BrS) with an S-ICD are scarce. OBJECTIVE: We aimed to establish the frequency and predictors of IS in this population. METHODS: We analyzed the clinical and electrocardiographic characteristics, automated screening test data, device programming, and IS occurrence in adult patients with BrS with an S-ICD. RESULTS: Thirty-nine patients were enrolled (69% male, mean age at diagnosis 46 ± 13 years, mean age at implantation 48 ± 13 years). During a mean follow-up of 26 ± 21 months, 18% patients experienced IS. Patients with IS were younger at the time of diagnosis (36 ± 8 vs. 48 ± 13 years, p = .018) and S-ICD implantation (38 ± 9 vs. 50 ± 23 years, p = .019) and presented with spontaneous type 1 Brugada electrocardiogram pattern more frequently at diagnosis or during follow-up (71% vs. 25%, p = .018). During automated screening tests, patients with IS showed lower QRS voltage in the primary vector in the supine position (0.58 ± 0.26 vs. 1.10 ± 0.35 mV, p = .011) and lower defibrillator automated screening score in the primary vector in the supine (123 ± 165 vs. 554 ± 390 mV, p = .005) and standing (162 ± 179 vs. 486 ± 388 mV, p = .038) positions. Age at diagnosis was the only independent predictor of IS (hazard ratio = 0.873, 95% confidence interval: 0.767-0.992, p = .037). CONCLUSION: IS was a frequent complication in patients with BrS with an S-ICD. Younger age was independently associated with IS. A more thorough screening process might help prevent IS in this population.

Outcomes on safety and efficacy of left atrial appendage occlusion in end stage renal disease patients undergoing dialysis.

BACKGROUND: In patients with end stage renal disease and atrial fibrillation (AF), undergoing chronic dialysis, direct oral agents are contraindicated and warfarin does not fully prevent embolic events while increasing the bleeding risk. The high hemorrhagic risk represents the main problem in this population. Aim of the study was to estimate the safety and efficacy for thromboembolic prevention of left atrial appendage (LAA) occlusion in a cohort of dialysis patients with AF and high hemorrhagic risk. METHODS: Ninety-two dialysis patients with AF who underwent LAA occlusion were recruited. For comparative purposes, two cohorts of dialysis patients with AF, one taking warfarin (oral anticoagulant therapy, OAT cohort, n = 114) and the other not taking any OAT (no-therapy cohort, n = 148) were included in the study. Primary endpoints were (1) incidence of peri-procedural complications, (2) incidence of 2-year thromboembolic and hemorrhagic events, (3) mortality at 2 years. In order to evaluate the effect of the LAA occlusion on the endpoints with respect to the OAT and No-therapy cohorts, a multivariable Cox regression model was applied adjusted for possible confounding factors. RESULTS: The device was successfully implanted in 100% of cases. Two major peri-procedural complications were reported. No thromboembolic events occurred at 2-year follow-up. The adjusted multivariable Cox regression model showed no difference in bleeding risk in the OAT compared to the LAA occlusion cohort in the first 3 months of follow-up [HR 1.65 (95% CI 0.43-6.33)], when most of patients were taking two antiplatelet drugs. In the following 21 months the bleeding incidence became higher in OAT patients [HR 6.48 (95% CI 1.32-31.72)]. Overall mortality was greater in both the OAT [HR 2.76 (95% CI 1.31-5.86)] and No-Therapy [HR 3.09 (95% CI 1.59-5.98)] cohorts compared to LAA occlusion patients. CONCLUSIONS: The study could open the way to a non-pharmacological option for thromboembolic protection in dialysis patients with AF and high bleeding risk.

Vascular Assisted Tracking for Challenging Transradial Percutaneous Intervention.

BACKGROUND: TRA is recommended as the preferred approach to perform coronary angiography and PCI. Despite this, TRA-PCI is burdened by a high access site crossover rate. Assisted-tracking techniques (balloon-assisted tracking and pigtail-assisted tracking) have showed to solve some of the issues related with challenging TRA procedures, but few data exist about procedural outcomes. Aim of the study was to evaluate the efficacy and safety of the assisted-tracking (AsTra) techniques during transradial (TRA) percutaneous coronary intervention (PCI). METHODS: From January 2016 to December 2019, 1682 TRA-PCI procedures were performed. Starting from January 2018, AsTra techniques were adopted in 72 cases of challenging TRA-PCI, and clinical data, procedural results and 30 days follow-up data were retrospectively collected. Because not all interventionalists used AsTra techniques, we had the opportunity to evaluate if their utilization influenced TRA-PCI rates. To this purpose, we identified two groups of interventionalists and tested the hypothesis that these techniques could lead to a significant improvement in TRA-PCI rates. RESULTS: Between January 2016 and December 2019, TRA-PCI rates increased from 68.5% to 95%. The TRA-PCI success rate increased significantly for interventionalists who adopted assisted-tracking techniques (p-value < 0.0001 for year 2019; p-value = 0.003 for year 2018). CONCLUSIONS: Assisted-tracking techniques appear to be effective in increasing TRA-PCI rates. Their use is associated with low complication and low access crossover rates.

Left atrial appendage occlusion in atrial fibrillation patients with previous intracranial bleeding: A national multicenter study.

BACKGROUND: Intracranial hemorrhage (ICH) represents the most serious complication of oral anticoagulant therapy (OAT) in patients with atrial fibrillation (AF), and AF patients with previous ICH are a challenge for clinicians. Left atrial appendage (LAA) occlusion has emerged as an alternative option for AF patients not suitable for OAT. Currently, few data are available on long term outcomes after LAA occlusion in this population. We evaluated the safety and efficacy of LAA occlusion in a cohort of patients with AF and previous ICH. METHODS: This is a multicenter, observational, retrospective study involving 5 LAA occlusion centers in Italy. It includes all consecutive patients (n = 120) with previous ICH who underwent LAA occlusion for nonvalvular AF and high thromboembolic risk. Procedural outcomes, post-procedural therapies and 12-months follow-up data were analyzed. RESULTS: The device was successfully implanted in 100% of cases, with a 6% of major peri-procedural complications. 59% had a prior ICH during OAT. The sample had a high risk of stroke (5.18%/year) and bleeding (6.62%/year). 30% were discharged on single and 54.2% on dual antiplatelet therapy. The expected annual risk for thromboembolism was 5.1%. Excluding periprocedural ischemic complications, the stroke annual rate was 1.8%. The expected annual risk of bleeding was 6.7%. The observed annual bleeding rate was 5.45%. CONCLUSIONS: Percutaneous LAA occlusion is an effective option for AF patients and previous intracranial hemorrhage. After LAA occlusion, a single antiplatelet therapy strategy could be considered for patients with the highest risk of recurrent bleeding.