The period following heart failure hospitalization (HFH) is a vulnerable time with high rates of death or recurrent HFH.OBJECTIVE To evaluate clinical characteristics, outcomes, and treatment response to vericiguat according to prespecified index event subgroups and time from index HFH in the Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA) trial. DESIGN, SETTING, AND PARTICIPANTSAnalysis of an international, randomized, placebo-controlled trial. All VICTORIA patients had recent (<6 months) worsening HF (ejection fraction <45%). Index event subgroups were less than 3 months after HFH (n = 3378), 3 to 6 months after HFH (n = 871), and those requiring outpatient intravenous diuretic therapy only for worsening HF (without HFH) in the previous 3 months (n = 801). Data were analyzed between May 2, 2020, and May 9, 2020.INTERVENTION Vericiguat titrated to 10 mg daily vs placebo. MAIN OUTCOMES AND MEASURESThe primary outcome was time to a composite of HFH or cardiovascular death; secondary outcomes were time to HFH, cardiovascular death, a composite of all-cause mortality or HFH, all-cause death, and total HFH. RESULTS Among 5050 patients in the VICTORIA trial, mean age was 67 years, 24% were women, 64% were White, 22% were Asian, and 5% were Black. Baseline characteristics were balanced between treatment arms within each subgroup. Over a median follow-up of 10.8 months, the primary event rates were 40.9, 29.6, and 23.4 events per 100 patient-years in the HFH at less than 3 months, HFH 3 to 6 months, and outpatient worsening subgroups, respectively. Compared with the outpatient worsening subgroup, the multivariable-adjusted relative risk of the primary outcome was higher in HFH less than 3 months (adjusted hazard ratio, 1.48; 95% CI, 1.27-1.73), with a time-dependent gradient of risk demonstrating that patients closest to their index HFH had the highest risk. Vericiguat was associated with reduced risk of the primary outcome overall and in all subgroups, without evidence of treatment heterogeneity. Similar results were evident for all-cause death and HFH. Addtionally, a continuous association between time from HFH and vericiguat treatment showed a trend toward greater benefit with longer duration since HFH. Safety events (symptomatic hypotension and syncope) were infrequent in all subgroups, with no difference between treatment arms.CONCLUSIONS AND RELEVANCE Among patients with worsening chronic HF, those in closest proximity to their index HFH had the highest risk of cardiovascular death or HFH, irrespective of age or clinical risk factors. The benefit of vericiguat did not differ significantly across the spectrum of risk in worsening HF.
Background: Insertable cardiac monitors are utilized for the diagnosis of arrhythmias and traditionally have been inserted within hospitals. Recent code updates allow for reimbursement of office-based insertions; however, there is limited information regarding the resources and processes required to support in-office insertions. We sought to determine the safety and feasibility of in-office insertion of the BioMonitor 2 and better understand in-office procedures, including patient selection, pre-insertion protocols, resource availability, and staff support.Methods: Patients meeting an indication for a rhythm monitor were prospectively enrolled into this single-arm, non-randomized trial. All patients underwent insertion in an office setting. Two follow-up visits at days 7 and 90 were required. Information on adverse events, device performance, office site preparations, and resource utilization were collected.Results: Eighty-two patients were enrolled at six sites. Insertion was successful in all 77 patients with an attempt. Oral anticoagulation was stopped in 20.8% of patients and continued through insertion in 23.4%, while prophylactic antibiotics were infrequently utilized (37.7% of study participants). On average, the procedure required a surgeon plus two support staff and 35 min in an office room to complete the 8.4 min insertion procedure. The mean R-wave amplitude was 0.77 mV at insertion and 0.67 mV at 90-days with low noise burden (2.7%). There were no procedure related complications. Two adverse events were reported (event rate 2.7% [95% CI 0.3, 9.5%]). Conclusions:In-office insertion of the BioMonitor 2 is safe and feasible. Devices performed well with high R-wave amplitudes and low noise burden. These results further support shifting cardiac monitor insertions to office-based locations.
It has been known for some time that mitral annulus calcification is common in end-stage renal disease (ESRD) patients on long-term dialysis, as well as in elderly patients without renal failure. However, a systematic comparison of cardiac calcification in these two types of patients has not yet been made. We examined two-dimensional echocardiograms in 33 patients with ESRD (mean age 66 +/- 10 years) and in 34 other patients with intracardiac calcification but no ESRD (mean age 69 +/- 9 years), with particular attention to precise anatomic location of calcification. Age was not significantly different in the two groups. The incidences of posterior mitral annulus calcification and aortic valve calcification were not significantly different in the ESRD and non-ESRD groups, though mitral annulus calcification tended to be larger in ESRD patients. Basal mitral leaflet calcification and papillary muscle calcification was much more common in the ESRD group. Calcification of intervalvar fibrosa and of tricuspid annulus were noted only in ESRD patients.
p u l m o n i c valve regurgitation, two-dimensional echocardiography, diastolic prolapse, pultnonic valve cusp Standard textbooks of cardiology and echocardiography enumerate many causes of pulmonic valve regurgitation, but diastolic pro-Address for correspondence and reprint requests: Ivan A. DCruz, M.D., VA Medical Center, Cardiology Section, 1030 Jefferson Ave., Memphis, TN 38104. Fax: 901-577-7430.lapse of the valve is not mentioned among them. We recently encountered two patients in whom two-dimensional (2-D) echocardiography showed diastolic prolapse of a pulmonic valve cusp, and color flow Doppler revealed an unusual tangential medially directed jet.Patient 1, a 42-year-old man, had a short grade 2 systolic murmur and early diastolic murmur at the left sternal border. No systolic Figure 1. patient 1 showing diastolic prolapse of one of the cusps into the right ventricle.
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