Sodium-glucose cotransporter-2 inhibitors (SGLT-2 inhibitors) are new glucose-lowering drugs (GLDs) with demonstrated cardiovascular benefits in patients with heart disease and type-2 diabetes mellitus (T2DM). However, their safety and efficacy when prescribed at hospital discharge are unexplored. This prospective, observational, longitudinal cohort study included 104 consecutive T2DM patients discharged from the cardiology department between April 2018 and February 2019. Patients were classified based on SGLT-2 inhibitor prescription and adjusted by propensity-score matching. The safety outcomes included discontinuation of GLDs; worsening renal function; and renal, hepatic, or metabolic hospitalization. The efficacy outcomes were death from any cause, cardiovascular death, cardiovascular readmission, and combined clinical outcome (cardiovascular death or readmission). The results showed that, the incidence rates of safety outcomes were similar in the SGLT-2 inhibitor or non-SGLT-2 inhibitor groups. Regarding efficacy, the SGLT-2 inhibitors group resulted in a lower rate of combined clinical outcomes (18% vs. 42%; hazard ratio (HR), 0.35; p = 0.02), any cause death (0% vs. 24%; HR, 0.79; p = 0.001) and cardiovascular death (0% vs. 17%; HR, 0.83; p = 0.005). No significant differences were found in cardiovascular readmissions. SGLT-2 inhibitor prescription at hospital discharge in patients with heart disease and T2DM was safe, well tolerated, and associated with a reduction in all-cause and cardiovascular deaths.
Background
The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares
peri
-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX.
Methods
Prospective, multicenter, “real-world” registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center’s prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed ≤ 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared.
Results
359 patients [mean age 75.5 (SD8.1), CHA
2
DS
2
-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major
peri
-procedural complications. No differences in efficacy or safety results according to the centeŕs previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed.
Conclusions
The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of
peri
-procedural complications, regardless of operatoŕs experience with its previous device iteration or the number of Watchman FLX devices implanted.
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