Left Atrial Appendage Closure Compared With Oral Anticoagulants for Patients With Atrial Fibrillation: A Systematic Review and Network Meta-Analysis.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) has been suggested as an alternative to long-term oral anticoagulation for nonvalvular atrial fibrillation, but comparative data remain scarce. We aimed to assess ischemic and bleeding outcomes of LAAC compared with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) for the prevention of cardioembolic events in patients with atrial fibrillation. METHODS AND RESULTS: Embase and MEDLINE were searched for randomized trials comparing LAAC, VKAs, and DOACs. The primary efficacy end point was any stroke or systemic embolism. Treatment effects were calculated from a network meta-analysis and ranked according to the surface under the cumulative ranking curve. Seven trials and 73 199 patients were included. The risk of the primary end point was not statistically different between LAAC versus VKAs (odds ratio [OR], 0.92 [95% CI, 0.62-1.50]) and LAAC versus DOACs (OR, 1.11 [95% CI, 0.71-1.73]). LAAC and DOACs resulted in similar risk of major or minor (OR, 0.93 [95% CI, 0.61-1.42]) and major bleeding (OR, 0.92 [95% CI, 0.58-1.46]); however, after exclusion of procedural bleeding, bleeding risk was significantly lower in those undergoing LAAC. Both LAAC and DOACs reduced the risk of all-cause death  compared with VKAs (LAAC versus VKAs: OR, 0.70 [95% CI, 0.53-0.91]; DOACs versus VKAs: OR, 0.90 [95% CI, 0.85-0.95], respectively). DOACs ranked as the best treatment for stroke or systemic embolism prevention (66.9%) and LAAC for reducing major bleeding (63.9%) and death (96.4%). CONCLUSIONS: As a nonpharmacological alternative to oral anticoagulation for atrial fibrillation, LAAC showed similar efficacy and safety compared with VKAs or DOACs. Prospective confirmation from larger studies is warranted.

Steerable Delivery Sheath for Left Atrial Appendage Closure in Patients With Severely Enlarged Left Atria.

Background: Enlarged left atrium (LA) is frequently identified in patients who undergo left atrial appendage closure (LAAC) and negatively affects the device's final position and intervention results. Steerable delivery sheath (SDS) could represent an option to overcome these difficulties. We aimed to assess the feasibility of SDS-assisted procedures and compare their efficacy to the standard sheath strategy. Methods: This study analyzed patients from our institution's LAAC registry who had severe LA enlargement on CT scan (index LA volume >90 mL/m2) and underwent AMULET device implantation between January 2019 and March 2023. The patients underwent postprocedural CT scan to assess the device's position, residual LAA filling, and peridevice leaks. Results: A total of 195 consecutive patients were screened and 47 (24%) met the inclusion criteria (n = 22 SDS group; n = 25 standard group). There was no difference in baseline clinical, anatomical, or procedural characteristics. The procedural technical success (96%) and complication rates (9% vs 4%; P = .59) were comparable in both groups. Post-LAAC CT scans were obtained in 19 SDS group and 22 standard group patients. We observed significantly lower incidences of residual patent LAA (26% vs 72%; P = .005), peridevice leaks (16% vs 64%; P = .004), and off-axis device position (0% vs 27%; P = .02) in SDS compared to the standard group, suggesting a better LAA sealing. Conclusions: Severe LA enlargement was frequent among LAAC candidates. In this situation, the use of SDS appears feasible and safe, leading to more efficient closures on follow-up imaging without a higher risk of periprocedural complications.

Age and Vasodilator Response to Different Hyperemic Agents: Adenosine versus Contrast Medium.

Background: Age-related remodelling has the potential to affect the microvascular response to hyperemic stimuli. However, its precise effects on the vasodilatory response to adenosine and contrast medium, as well as its influence on fractional flow reserve (FFR) and contrast fractional flow reserve (cFFR), have not been previously investigated. We investigate the impact of age on these indices. Methods: We extrapolated data from the post-revascularization optimization and physiological evaluation of intermediate lesions using fractional flow reserve (PROPHET-FFR) and The Multi-center Evaluation of the Accuracy of the Contrast MEdium INduced Pd/Pa RaTiO in Predicting (MEMENTO) studies. Only lesions with a relevant vasodilatory response to adenosine and contrast medium were considered of interest. A total of 2080 patients, accounting for 2294 pressure recordings were available for analysis. The cohort was stratified into three age terciles. Age-dependent correlations with FFR, cFFR, distal pressure/aortic pressure (Pd/Pa) and instantaneous wave-free ratio (iFR) were calculated. The vasodilatory response was calculated in 1619 lesions (with both FFR and cFFR) as the difference between resting and hyperaemic pressure ratios and correlated with aging. The prevalence of FFR-cFFR discordance was assessed. Results: Age correlated positively to FFR (r = 0.062, p = 0.006), but not with cFFR (r = 0.024, p = 0.298), Pd/Pa (r = -0.015, p = 0.481) and iFR (r = -0.026, p = 0.648). The hyperemic response to adenosine (r = -0.102, p ≤ 0.0001) and to contrast medium (r = -0.076, p = 0.0023) showed a negative correlation with age. When adjusted for potential confounders, adenosine induced hyperaemia was negatively associated with age (p = 0.04 vs p = 0.08 for cFFR). Discordance decreased across age terciles (14.64% vs 12.72% vs 10.12%, p = 0.032). Conclusions: As compared to adenosine, contrast induced hyperaemia appeared to be less affected by age. cFFR may be considered a more stable and reproducible tool to assess epicardial stenosis in elderly patients. Clinical Trial Registration: PROPHET-FFR STUDY, Clinicaltrials.gov (NCT05056662).

[A complicated left atrial appendage closure : percutaneous management of LAA rupture]. / Ma fermeture d'auricule s'est compliquée : traitement percutané d'une rupture d'auricule gauche.

An 81-year-old patient was referred for left atrial appendage closure. Anatomical LAA analysis by CT scan showed an inverted chicken wing morphology. The procedure was performed through i an infero-anterior transseptal puncture and led to "sandwich" closure strategy using an AMPLATZER AMULET 25 mm device. Despite successful deployment of the occluder, a hemopericardium soon developed related to an iatrogenic LAA perforation/partial rupture and leading to major hemodynamic instability. After pericardocentesis, it was decided to inject activated thrombin into the pericardial sac to achieve in situ hemostasis. This strategy enabled coagulation of the hemopericardium and cessation of active bleeding, without recourse to surgical treatment.

Embolization of percutaneous left atrial appendage closure devices: Timing, management and clinical outcomes.

BACKGROUND: Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication. OBJECTIVES: We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry. METHODS: Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. RESULTS: Sixty-seven centers contributed data. Device embolization occurred in 108 patients. In 70.4 % of cases, it happened within the first 24 h of the procedure. The device was purposefully left in the LA and the aorta in two (1.9 %) patients, an initial percutaneous retrieval was attempted in 81 (75.0 %) and surgery without prior percutaneous retrieval attempt was performed in 23 (21.3 %) patients. Two patients died before a retrieval attempt could be made. In 28/81 (34.6 %) patients with an initial percutaneous retrieval attempt a second, additional attempt was performed, which was associated with a high mortality (death in patients with one attempt: 2.9 % vs. second attempt: 21.4 %, p < 0.001). The primary outcome (bailout surgery, cardiogenic shock, stroke, TIA, and/or death) occurred in 47 (43.5 %) patients. Other major complications related to device embolization occurred in 21 (19.4 %) patients. CONCLUSIONS: The majority of device embolizations after LAA closure occurs early. A percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was unsuccessful. CONDENSED ABSTRACT: This dedicated multicenter registry examined timing, management, and clinical outcome of device embolization. Early embolization (70.4 %) was most frequent. As a first rescue attempt, percutaneous retrieval was preferred in 75.0 %, followed by surgical removal (21.3 %). In patients with a second retrieval attempt a higher mortality (death first attempt: 2.9 % vs. death second attempt: 24.1 %, p < 0.001) was observed. Mortality (10.2 %) and the major complication rate after device embolization were high.

Diagnostic performance of deep learning to exclude coronary stenosis on CT angiography in TAVI patients.

We evaluated the diagnostic performance of a deep-learning model (DLM) (CorEx®, Spimed-AI, Paris, France) designed to automatically detect > 50% coronary stenosis on coronary computed tomography angiography (CCTA) images. We studied inter-observer variability as an additional aim. CCTA images obtained before transcatheter aortic valve implantation (TAVI) were assessed by two radiologists and the DLM, and the results were compared to those of invasive coronary angiography (ICA) used as the reference standard. 165 consecutive patients underwent both CCTA and ICA as part of their TAVI work-up. We excluded the 42 (25.5%) patients with a history of stenting or bypass grafting and the 23 (13.9%) patients with low-quality images. We retrospectively subjected the CCTA images from the remaining 100 patients to evaluation by the DLM and compared the DLM and ICA results. All 25 patients with > 50% stenosis by ICA also had > 50% stenosis by DLM evaluation of CCTA: thus, the DLM had 100% sensitivity and 100% negative predictive value. False-positive DLM results were common, yielding a positive predictive value of only 39% (95% CI, 27-51%). Two radiologists with 3 and 25 years' experience, respectively, performed similarly to the DLM in evaluating the CCTA images; thus, accuracy did not differ significantly between each reader and the DLM (p = 0.625 and p = 0.375, respectively). The DLM had 100% negative predictive value for > 50% stenosis and performed similarly to experienced radiologists. This tool may hold promise for identifying the up to one-third of patients who do not require ICA before TAVI.

Intravascular Imaging Findings After PCI in Patients With Focal and Diffuse Coronary Artery Disease.

BACKGROUND: Following percutaneous coronary intervention (PCI), optical coherence tomography provides prognosis information. The pullback pressure gradient is a novel index that discriminates focal from diffuse coronary artery disease based on fractional flow reserve pullbacks. We sought to investigate the association between coronary artery disease patterns, defined by coronary physiology, and optical coherence tomography after stent implantation in stable patients undergoing PCI. METHODS AND RESULTS: This multicenter, prospective, single-arm study was conducted in 5 countries (NCT03782688). Subjects underwent motorized fractional flow reserve pullbacks evaluation followed by optical coherence tomography-guided PCI. Post-PCI optical coherence tomography minimum stent area, stent expansion, and the presence of suboptimal findings such as incomplete stent apposition, stent edge dissection, and irregular tissue protrusion were compared between patients with focal versus diffuse disease. Overall, 102 patients (105 vessels) were included. Fractional flow reserve before PCI was 0.65±0.14, pullback pressure gradient was 0.66±0.14, and post-PCI fractional flow reserve was 0.88±0.06. The mean minimum stent area was 5.69±1.99 mm2 and was significantly larger in vessels with focal disease (6.18±2.12 mm2 versus 5.19±1.72 mm2, P=0.01). After PCI, incomplete stent apposition, stent edge dissection, and irregular tissue protrusion were observed in 27.6%, 10.5%, and 51.4% of the cases, respectively. Vessels with focal disease at baseline had a lower prevalence of incomplete stent apposition (11.3% versus 44.2%, P=0.002) and more irregular tissue protrusion (69.8% versus 32.7%, P<0.001). CONCLUSIONS: Baseline coronary pathophysiological patterns are associated with suboptimal imaging findings after PCI. Patients with focal disease had larger minimum stent area and a higher incidence of tissue protrusion, whereas stent malapposition was more frequent in patients with diffuse disease.

Contribution of the Optical Coherence Tomography in Calcified Lesions.

Coronary artery calcification is a complex process found predominantly in the elderly population. Coronary angiography frequently lacks sensitivity to detect, evaluate and quantify these lesions. Yet calcified lesions are considered stable, it remains associated with a higher rate of peri procedural complications during percutaneous coronary intervention (PCI) including an increased risk of stent under expansion and struts mal apposition leading to poor clinical outcome. Intracoronary imaging (Intravascular Ultra Sound (IVUS) and Optical Coherence Tomography (OCT)) allows better calcified lesions identification, localization within the coronary artery wall (superficial or deep calcifications), quantification. This lesions characterization allows a better choice of dedicated plaque-preparation tools (modified balloons, rotational or orbital atherectomy, intravascular lithotripsy) that are crucial to achieve optimal PCI results. OCT could also assess the impact of these tools on the calcified plaque morphology (plaque fracture, burring effects…). An OCT-guided tailored PCI strategy for calcified lesions still requires validation by clinical studies which are currently underway.