The assessment of the left main coronary artery (LMCA) by coronary angiography has several limitations. The fractional flow reserve (FFR) is useful for the functional evaluation of LMCA stenoses. The instantaneous wave-free ratio (iFR), a resting index, was developed to simplify functional coronary assessment. However, its performance for LMCA stenoses has yet to be explored. The iFR was measured at rest, and the FFR was measured under maximal hyperemia. We calculated that a sample size of 90 lesions would have provided 90% power at a 5% significance level to detect an Area Under the Curve (AUC) < 0.7 for the iFR to identify FFR-positive stenoses. A total of 91 measurements were performed on angiographically intermediate LMCA stenoses at three centers. The comparison between the iFR and the FFR showed a significant correlation (r = 0.67, p < 0.001). At receiver operating characteristic (ROC) analysis, the iFR revealed a good diagnostic performance when compared to the FFR (AUC = 0.84; p < 0.001). A classification agreement between the iFR and the FFR was recorded in 81% of cases. The left ventricular ejection fraction (LVEF) was an independent predictor of the discrepancy between the FFR and iFR values (p = 0.040). The present study is the first demonstrating that the assessment of LMCA stenoses with the instantaneous wave-free ratio is a reliable adenosine-free alternative to classic fractional flow reserve. If confirmed in larger populations, these findings could be of relevance for real world daily practice.
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.
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.
Background. The Lambre is a plug occluder for left atrial appendage closure (LAAC) in patients with atrial fibrillation (AF), but direct comparisons of the most used Watchman FLX and Lambre devices are lacking. Objectives. To compare the safety and efficacy of Lambre and the well-established Watchman FLX occluder for left atrial appendage (LAA) closure Methods. Between January 2023 and April 2025, a cohort of 253 consecutive patients who underwent LAAC with Lambre or Watchman FLX at Umberto I Hospital of Siracusa were included. The primary safety endpoint included major peri-procedural complications while the primary efficacy endpoint included all cause stroke, cardiovascular/unexplained death, systemic embolism and bleedings at a mean follow up of 12 months. 1:1 propensity score matching (PSM) was performed. Results. After PSM, 152 patients were included: Lambre group (n=76) and Watchman FLX group (n=76). The mean CHA2DS2-VASc score was 4.5 ± 1.3 (Lambre) vs. 4.5 ± 1.4( Watchman FLX), p=0.97; and the HAS-BLED score was 2.7 ± 0.9 vs. 2.7± 0.8, p=0.97. At a mean follow-up of 12 months, the primary efficacy endpoint (14.9% vs. 12.5%; HR, 1.57; 95% CI, 0.52–4.72; P = 0.77) and the primary safety endpoint (3.9% vs. 2.6%; HR, 1.51; CI 0.25-9.03; P=1) were similar between groups. Conclusions. LAAC with the Lambre device has demonstrated similar efficacy and safety to the Watchman devices. In a high-volume center, experienced operators, using both singleand double-element devices, can adopt a customized strategy based on each patient’s anatomy and achieve 100% successful left atrial closure.