Harmonized outcome measures for use in atrial fibrillation patient registries and clinical practice: Endorsed by the Heart Rhythm Society Board of Trustees.
Humans; Risk Factors; United States/epidemiology; Survival Rate/trends; Cardiology; Morbidity/trends; Risk Assessment/methods; Atrial fibrillation; Common data element; Data standard; Harmonization; Outcome measure; Patient outcome; Patient registry; Registries; Societies Medical; Atrial Fibrillation/complications/epidemiology; Outcome Assessment Health Care/methods; Stroke/epidemiology/etiology
BACKGROUND: Atrial fibrillation (AF) affects an estimated 33 million people worldwide, leading to increased mortality and an increased risk of heart failure and stroke. Many AF patient registries exist, but the ability to link and compare data across registries is hindered by differences in the outcome measures collected by each registry and a lack of harmonization. OBJECTIVES: The purpose of this project was to develop a minimum set of standardized outcome measures that could be collected in AF patient registries and clinical practice. METHODS: AF patient registries were identified through multiple sources and invited to join the workgroup and submit outcome measures. Additional measures were identified through literature searches and reviews of consensus statements. Outcome measures were categorized using the Agency for Healthcare Research and Quality's supported Outcome Measures Framework (OMF). A minimum set of broadly relevant measures was identified. Measure definitions were harmonized through in-person and virtual meetings. RESULTS: One hundred twelve outcome measures, including those from thirteen registries, were curated according to the OMF and then harmonized into a minimum set of measures in the OMF categories of survival (3 measures), clinical response (3 measures), events of interest (9 measures), patient-reported outcomes (2 measures), and resource utilization (3 measures). The harmonized definitions build on existing consensus statements. CONCLUSIONS: The harmonized measures represent a minimum set of outcomes that are relevant in AF research and clinical practice. Routine and consistent collection of these measures in registries and in other systems would support creation of a research infrastructure to efficiently address new questions and improve patient outcomes.
Calkins H; Gliklich RE; Leavy MB; Piccini JP; Hsu JC; Mohanty S; Lewis W; Nazarian S; Turakhia MP
Heart Rhythm
2019
2019-01
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
journalArticle
<a href="http://doi.org/10.1016/j.hrthm.2018.09.021" target="_blank" rel="noreferrer noopener">10.1016/j.hrthm.2018.09.021</a>
Use of a Novel Septal Occluder Device for Left Atrial Appendage Closure in Patients With Postsurgical and Postlariat Leaks or Anatomies Unsuitable for Conventional Percutaneous Occlusion.
atrial fibrillation; patent foramen ovale; mitral valve; atrial appendage; transoesophageal echocardiography
BACKGROUND: Interventional therapies aiming at excluding the left atrial appendage (LAA) from systemic circulation have been established as a valid alternative to oral anticoagulation in patients at high thromboembolic risk. However, their efficacy on stroke prophylaxis may be compromised owing to incomplete LAA closure. Additionally, the need for an alternative thromboembolic prevention may remain unmet in patients with contraindications to oral anticoagulation whose appendage anatomy is unsuitable for some conventional devices commercially available. We aimed at evaluating the feasibility of LAA closure with the novel Gore Cardioform Septal Occluder in patients with incomplete appendage ligation or anatomic features which do not meet the manufacturer's requirements for Watchman deployment. METHODS: Twenty-one consecutive patients (mean age: 72±6 years; 85.7% males; CHA(2)DS(2)-VASc: 4.5±1.4; HAS-BLED: 3.6±1.0) were included. Transesophageal echocardiography was performed within 2 months to assess for residual LAA patency. RESULTS: Fourteen patients had incomplete LAA closure following surgical (n=6) or Lariat ligation (n=8). In 7 patients with an appendage anatomy unsuitable for Watchman deployment, the mean maximal landing zone size and LAA depth were 14.4±1.3and 18.6±2.8 mm. Successful Cardioform Septal Occluder deployment was achieved in all patients. No peri-procedural complications were documented.Procedure and fluoroscopy times were 46±13 and 14±5 minutes. Follow-up transesophageal echocardiography after 58±9 days revealed complete LAA closure in all patients. CONCLUSIONS: Transcatheter LAA closure via a Cardioform Septal Occluder device might be a valid alternative in patients with residual leaks following failed appendage ligation or whose LAA anatomy does not meet the minimal anatomic criteria to accommodate a Watchman device.
Della Rocca DG; Horton RP; Tarantino N; Van Niekerk CJ; Trivedi C; Chen Q; Mohanty S; Anannab A; Murtaza G; Akella K; Gianni C; Bassiouny M; Ahmadian-Tehrani A; Al-Ahmad A; Burkhardt JD; Natale VN; Price M; Gallinghouse GJ; Gibson DN; Lakkireddy D; Di Biase L; Natale A
Circulation: Cardiovascular Interventions
2020
2020-09-18
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
journalArticle
<a href="http://doi.org/10.1161/circinterventions.120.009227" target="_blank" rel="noreferrer noopener">10.1161/circinterventions.120.009227</a>