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Background: The new-generation WATCHMAN FLX (Boston Scientific) device for left atrial appendage occlusion has been modified in various aspects to improve procedural results. No comparison of the WATCHMAN FLX device with the previous WATCHMAN device is available.Objective: We aimed to compare procedural results with WATCHMAN FLX in patients on dual antiplatelet therapy at ∼3 months with data with WATCHMAN (EWOLUTION [Registry on WATCHMAN Outcomes in Real-Life Utilization]).Methods: One hundred sixty-four consecutive patients receiving the WATCHMAN FLX device in 4 European centers were included in the retrospective ALSTER-FLX registry. As a control group for a matched-pair analysis, 1020 patients treated with the WATCHMAN device and data up to first follow-up (∼3 months) from EWOLUTION were used.Results: Implantation was successful in all ALSTER-FLX patients (100%) and similar to results in EWOLUTION (99%) (P = .2). We observed no stroke or device embolization in ALSTER-FLX similar to EWOLUTION (stroke 0.5%, device embolization 0.4%) at 3 months. Numerically less ALSTER-FLX patients (2.4%) developed a device-associated thrombus as compared with 3.7% EWOLUTION patients, yet without reaching statistical significance after matching (median [95% confidence interval] device-associated thrombus pairwise event difference 2 [0-6]; P = .1). WATCHMAN FLX implantation was associated with a significant higher sealing rate compared with EWOLUTION at 3 months (ALSTER-FLX 90% vs EWOLUTION 79.4%; P = .039 after matching). Major nonprocedural bleeding events and mortality were similar after matching (median event difference for bleeding 0 [-3 to 3]; P = .6 and death 1 [-2 to 4]; P = .3).Conclusion: Periprocedural, early 3-month outcomes with WATCHMAN FLX demonstrate a similar safety profile and an improved sealing rate compared to the WATCHMAN device. [ABSTRACT FROM AUTHOR]

Takotsubo syndrome (TTS) is a reversible form of heart failure with incompletely understood pathophysiology. This study analyzed altered cardiac hemodynamics during TTS to elucidate underlying disease mechanisms. Left ventricular (LV) pressure–volume loops were recorded in 24 consecutive patients with TTS and a control population of 20 participants without cardiovascular diseases. TTS was associated with impaired LV contractility (end-systolic elastance 1.74 mm Hg/mL vs 2.35 mm Hg/mL [ P = 0.024]; maximal rate of change in systolic pressure over time 1,533 mm Hg/s vs 1,763 mm Hg/s [ P = 0.031]; end-systolic volume at a pressure of 150 mm Hg, 77.3 mL vs 46.4 mL [ P = 0.002]); and a shortened systolic period (286 ms vs 343 ms [ P < 0.001]). In response, the pressure–volume diagram was shifted rightward with significantly increased LV end-diastolic (P = 0.031) and end-systolic (P < 0.001) volumes, which preserved LV stroke volume (P = 0.370) despite a lower LV ejection fraction (P < 0.001). Diastolic function was characterized by prolonged active relaxation (relaxation constant 69.5 ms vs 45.9 ms [ P < 0.001]; minimal rate of change in diastolic pressure –1,457 mm Hg/s vs –2,192 mm Hg/s [ P < 0.001]), whereas diastolic stiffness (1/compliance) was not affected during TTS (end-diastolic volume at a pressure of 15 mm Hg, 96.7 mL vs 109.0 mL [ P = 0.942]). Mechanical efficiency was significantly reduced in TTS (P < 0.001) considering reduced stroke work (P = 0.001), increased potential energy (P = 0.036), and a similar total pressure–volume area compared with that of control subjects (P = 0.357). TTS is characterized by reduced cardiac contractility, a shortened systolic period, inefficient energetics, and prolonged active relaxation but unaltered diastolic passive stiffness. These findings may suggest decreased phosphorylation of myofilament proteins, which represents a potential therapeutic target in TTS. (Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops [OCTOPUS]; NCT03726528) [Display omitted] [ABSTRACT FROM AUTHOR]