Validation and Final Results from the First Cardiac Lead Post-Approval Study Using Real-World Data.

Background: As part of Electrophysiology Predictable and Sustainable Implementation of National Registries (EP PASSION), a multi-stakeholder collaboration between the US Food and Drug Administration (FDA), academic and society partners, and cardiovascular implantable electronic device manufacturers, a 5-year bradycardia lead study transitioned from a traditional post-approval study (PAS) to a real-world data (RWD) approach using a novel method to evaluate chronic cardiac lead complications.

Methods: Lead complications were identified using a combination of diagnosis and procedure codes from 2013 to 2020 fee-for-service Medicare claims data along with BIOTRONIK device registration and Medical Device Reporting data from patients implanted between 2013 and 2015 with a Solia S lead. A proof-of-concept analysis was performed using McNemar's test to compare lead complications reported in the traditional PAS with lead complications identified in the RWD.

Prevalence and predictors of QTc prolongation in patients seen in a clozapine clinic in a real-world setting in Australia.

Background: Many antipsychotic drugs have been associated with QTc prolongation, which is a risk factor for sudden death. We studied the prevalence and predictors of QTc prolongation in treatment-resistant schizophrenia patients who were receiving clozapine in a real-world setting.

Methods: Data were extracted from the records of all schizophrenia patients aged 18-65 years, enrolled in a clozapine clinic in metropolitan Australia during October 2020 to April 2022, for whom ECG data were available.

MultiPole pacing in non-responders to cardiac resynchronization therapy: Results from the QP ExCELs/MPP sub-study.

Background: Multisite LV stimulation therapy allows for stimulation of two different left ventricular pacing vectors within a single LV lead and may improve responsiveness to cardiac resynchronization therapy (CRT). This study prospectively evaluated the safety and efficacy of the MultiPole Pacing (MPP) feature in CRT non-responder patients.

Methods And Results: CRT non-responders with a standard CRT-D indication were eligible for enrollment into the MPP Sub-Study.

Postnatal depression and infant growth in an urban area of Bangladesh.

Postnatal depression (PND) has been a common depressive mental disorder among the mothers in a low-income country like Bangladesh where stunting, underweight and wasting are prevalent among infants. The present prospective cohort study was carried out among 297 non-depressed and 103 depressed mothers (ages 18-36 years) to find the association between post natal depression and growth of infants. Data were collected by face to face interview through semi-structured questionnaires and anthropometric measurements were taken with proper anthropometric techniques and calibrated instruments.