BACKGROUND: We examined the effects of vericiguat compared with placebo in patients with heart failure with reduced ejection fraction enrolled in VICTORIA (Vericiguat Global Study in Patients With Heart Failure With Reduced Ejection Fraction) on health status outcomes measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and evaluated whether clinical outcomes varied by baseline KCCQ score. METHODS: KCCQ was completed at baseline and 4, 16, and 32 weeks. We assessed treatment effect on KCCQ using a mixed-effects model adjusting for baseline KCCQ and stratification variables. Cox proportional-hazards modeling was performed to evaluate the effect of vericiguat on clinical outcomes by tertiles of baseline KCCQ clinical summary score (CSS), total symptom score (TSS), and overall summary score (OSS). RESULTS: Of 5050 patients, 4664, 4741, and 4470 had KCCQ CSS (median [25th to 75th], 65.6 [45.8-81.8]), TSS (68.8 [47.9-85.4]), and OSS (59.9 [42.0-77.1]) at baseline; 94%, 88%, and 82% had data at 4, 16, and 32 weeks. At 16 weeks, CSS improved by a median of 6.3 in both arms; no significant differences in improvement were seen for TSS and OSS between the 2 groups (P=0.69, 0.97, and 0.13 for CSS, TSS, and OSS). Trends were similar at 4 and 32 weeks. Vericiguat versus placebo reduced cardiovascular death or heart failure hospitalization risk similarly across tertiles of baseline KCCQ CSS, TSS, and OSS (interaction P=0.13, 0.21, and 0.65). CONCLUSIONS: Vericiguat did not significantly improve KCCQ scores compared with placebo. Vericiguat reduced the risk of cardiovascular death or heart failure hospitalization across the range of baseline health status. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02861534.
The European Union (EU) General Data Protection Regulation (GDPR) imposes legal responsibilities concerning the collection and processing of personal information from individuals who live in the EU. It has particular implications for the remote monitoring of cardiac implantable electronic devices (CIEDs). This report from a joint Task Force of the European Heart Rhythm Association and the Regulatory Affairs Committee of the European Society of Cardiology (ESC) recommends a common legal interpretation of the GDPR. Manufacturers and hospitals should be designated as joint controllers of the data collected by remote monitoring (depending upon the system architecture) and they should have a mutual contract in place that defines their respective roles; a generic template is proposed. Alternatively, they may be two independent controllers. Self-employed cardiologists also are data controllers. Third-party providers of monitoring platforms may act as data processors. Manufacturers should always collect and process the minimum amount of identifiable data necessary, and wherever feasible have access only to pseudonymized data. Cybersecurity vulnerabilities have been reported concerning the security of transmission of data between a patient's device and the transceiver, so manufacturers should use secure communication protocols. Patients need to be informed how their remotely monitored data will be handled and used, and their informed consent should be sought before their device is implanted. Review of consent forms in current use revealed great variability in length and content, and sometimes very technical language; therefore, a standard information sheet and generic consent form are proposed. Cardiologists who care for patients with CIEDs that are remotely monitored should be aware of these issues.
- MeSH
- lidé MeSH
- následná péče metody organizace a řízení pracovní síly MeSH
- srdeční selhání * farmakoterapie ošetřování MeSH
- zajištění kvality zdravotní péče * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- novinové články MeSH
- rozhovory MeSH
Heart, ISSN 1355-6037 vol. 91, suppl. II, May 2005
48 s. : il., tab. ; 30 cm
- MeSH
- infarkt myokardu komplikace MeSH
- management nemoci MeSH
- srdeční selhání etiologie terapie MeSH
- Publikační typ
- kongresy MeSH
- sborníky MeSH
- Konspekt
- Patologie. Klinická medicína
- NLK Obory
- kardiologie
Heart, ISSN 1355-6037 vol. 88, suppl. 2, October 2002
ii46 s. : tab., grafy, mapy ; 30 cm
- MeSH
- kardiologie MeSH
- nemoci srdce MeSH
- srdeční selhání MeSH
- Publikační typ
- kongresy MeSH
- Konspekt
- Patologie. Klinická medicína
- NLK Obory
- kardiologie
