BACKGROUND: One-year outcomes of TRILUMINATE Pivotal (Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System Pivotal) found that transcatheter edge-to-edge repair (TEER) for the treatment of severe, symptomatic tricuspid regurgitation improved quality of life compared with medical therapy alone with similar rates of mortality and heart failure hospitalization. However, additional follow-up is necessary to determine the prolonged benefits of tricuspid TEER. METHODS: A total of 572 patients with severe, symptomatic tricuspid regurgitation were randomized to either tricuspid TEER+medical therapy (device group) or medical therapy alone (control). Two-year prespecified end points were recurrent heart failure hospitalization and freedom from all-cause mortality, tricuspid valve surgery, and tricuspid valve intervention after treatment visit, assessed in the intention-to-treat population. RESULTS: The annualized rate of recurrent heart failure hospitalizations through 2 years was significantly lower with tricuspid TEER compared with control (0.19 event per patient-year versus 0.26 event per patient-year; P =0.02; joint frailty model hazard ratio, 0.72; one-sided upper confidence limit, 0.93; P =0.02). Freedom from all-cause mortality, tricuspid valve surgery, and tricuspid valve intervention through 2 years was significantly higher with tricuspid TEER compared with control (77.6% versus 29.3%; P <0.0001), driven by more tricuspid valve intervention in control patients who crossed over to device treatment (3.8% versus 61.5%). Rates of all-cause mortality (17.9% versus 17.1%) and tricuspid valve surgery (2.3% versus 4.3%) were similar between groups. Moderate or less tricuspid regurgitation was present in 84% at 2 years in the device group. CONCLUSIONS: At the 2-year follow-up, tricuspid TEER appeared safe, significantly reduced tricuspid regurgitation severity, and decreased rates of heart failure hospitalization compared with medical therapy alone. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03904147.

Background: Severe coronavirus disease 2019 (COVID‐19) is characterized by a proinflammatory state with high mortality. Statins have anti‐inflammatory effects and may attenuate the severity of COVID‐19. Methods and Results: An observational study of all consecutive adult patients with COVID‐19 admitted to a single center located in Bronx, New York, was conducted from March 1, 2020, to May 2, 2020. Patients were grouped as those who did and those who did not receive a statin, and in‐hospital mortality was compared by competing events regression. In addition, propensity score matching and inverse probability treatment weighting were used in survival models to examine the association between statin use and death during hospitalization. A total of 4252 patients were admitted with COVID‐19. Diabetes mellitus modified the association between statin use and in‐hospital mortality. Patients with diabetes mellitus on a statin (n=983) were older (69±11 versus 67±14 years; P <0.01), had lower inflammatory markers (C‐reactive protein, 10.2; interquartile range, 4.5–18.4 versus 12.9; interquartile range, 5.9–21.4 mg/dL; P <0.01) and reduced cumulative in‐hospital mortality (24% versus 39%; P <0.01) than those not on a statin (n=1283). No difference in hospital mortality was noted in patients without diabetes mellitus on or off statin (20% versus 21%; P =0.82). Propensity score matching (hazard ratio, 0.88; 95% CI, 0.83–0.94; P <0.01) and inverse probability treatment weighting (HR, 0.88; 95% CI, 0.84–0.92; P <0.01) showed a 12% lower risk of death during hospitalization for statin users than for nonusers. Conclusions: Statin use was associated with reduced in‐hospital mortality from COVID‐19 in patients with diabetes mellitus. These findings, if validated, may further reemphasize administration of statins to patients with diabetes mellitus during the COVID‐19 era.

Background: Gastrointestinal bleeding (GIB) is one of the principal adverse events affecting patients with continuous-flow left ventricular assist devices (CF-LVADs). Despite the early recognition that GIB is commonly because of gastrointestinal angiodysplasia (GIAD), the exact pathophysiology of this process remains elusive. It has been postulated that the abnormal hemodynamic profile in CF-LVAD patients may activate the angiogenesis signaling cascade via the HIF (hypoxia-inducible factor)-1α/angiopoietin-2 pathway leading to formation of GIADs. Digoxin is a potent inhibitor of HIF-1α synthesis, and we hypothesized that its use reduces the incidence of GIAD and GIB in patients with CF-LVAD. Methods and Results: Charts of all adult patients implanted with CF-LVAD between February 2006 and February 2017 were reviewed with particular emphasis on occurrence and cause of GIB. Fifty-four of 199 patients (27%) experienced a GIB. Overall frequency of GIB was lower in the 64 patients receiving digoxin compared with the 135 patients not receiving digoxin (16% versus 33%, P =0.01). Multivariable-adjusted Cox regression analysis confirmed that digoxin use was independently associated with a reduced risk for overall GIB (hazard ratio, 0.49; 95% CI, 0.24–0.98; P =0.045). GIBs were then categorized as non-GIAD, GIAD, or likely GIAD. Although the incidence of non-GIAD was similar in both groups (11% versus 7%, P =0.41), the frequency of GIAD/likely GIAD bleeding was significantly reduced in the digoxin group (5% versus 25%, P =0.0003). Multivariable-adjusted analysis confirmed that digoxin use was independently associated with a reduced risk for GIAD/likely GIAD bleeding (hazard ratio, 0.18; 95% CI, 0.06–0.6; P =0.005). However, digoxin use was not associated with reduced risk for non-GIAD GIB (hazard ratio, 1.54; 95% CI, 0.58–4.08; P =0.39). Conclusions: Use of digoxin was associated with a significant reduction in GIAD-related GIB in patients with CF-LVAD.