The OPTI-MIND study: a prospective, observational study of pacemaker patients according to pacing modality and primary indications

Abstract

The present analysis showed that frequent deviations occurred when comparing the device settings at discharge from the pacemaker implant in clinical practice to the available guidelines on pacing mode selection. Analysis of 2-year outcomes in the OPTI-MIND study will provide an insight into whether specific physiological settings could improve the quality of pacing with a positive effect on patient outcome.

Pacemaker Programming, Physiologic Pacing Settings, and Clinical Outcomes in Real-world Practice: Results from the OPTI-MIND Clinical Study

“…6 Indeed, only 46.6% of patients with SSS and 28% of AVB patients in sinus rhythm received a strictly physiologic programming according to the generic principles of maintenance of AV synchrony, avoidance of unnecessary atrial/ventricular pacing when not indicated, allowance of rate increase in chronotropically incompetent patients. 7 Physiologic programming was not associated with increased mortality or hospitalizations. However, in the subgroup with AVB as primary rhythm disease, physiologic pacing was associated with a lower incidence of new-onset atrial tachyarrhythmias.…”

“…These criteria were used as a surrogate definition of physiologic pacing and used together with clinical variables to stratify clinical events of primary endpoint. According to the pre-specified secondary study endpoints 7 we investigated 1) the difference in the composite of cardiac cause mortality or first cardiac-related hospitalization between groups programmed with physiologic versus non-physiologic settings at baseline; 2) incidence at 2 years of documented atrial fibrillation (AF) episodes associated with any unplanned hospital visit, including hospitalizations for symptoms and/or treatment of AF in the subgroup of patients without AF as the primary rhythm disease at enrolment; 3) comparison between pacing settings at discharge and final programmed pacing parameters at 2 years; 4) clinical development of indications and/or upgrade to implantable cardioverter-defibrillator (ICD) or cardiac resynchronization device (CRT). Details on study design, together with analysis of baseline data have been previously published.…”

“…Details on study design, together with analysis of baseline data have been previously published. 7 Baseline device programming settings obtained at a subject's enrollment, occurring per study protocol in between 1 and 15 days since device implant were used to define patients programmed to physiologic pacing setting or not. Modifications in device programming during follow-up leading to a potential change of group were analyzed by comparing final programming setting (at 2 years or latest available) to the original one.…”

“…Physiologic programming occurred most frequently in patients with SND and with AF as primary rhythm disease, whereas non-physiologic pacing was more frequently observed in patients with AVB, 7 showing that evidence-based indications have a partial impact on pacing mode selection and device programming for SND patients, while non-physiologic pacing is more common in AVB patients. Indeed, AV synchrony was not maintained in 10% of AVB patients and unnecessary atrial stimulation was delivered in 59%.…”

“…A summary of basic demographics, medical history, and clinical characteristics is reported in Table 2: 693/ 1674 (41.4%) subjects received a physiological pacing setting at the baseline visit. 7 Among the 981 patients not programmed with physiologic settings, causes of nonphysiological pacing included absence of AV synchrony through the appropriate pacing mode (183, 10.9%); no avoidance of unnecessary right atrial pacing (with lower rate limit equal or above 60 ppm) in subjects without sinus node dysfunction (440, 26.3%); no avoidance of unnecessary RV stimulation in subjects without AV conduction block (178, 10.6%), and absence of a rate increase during exercise with a rate responsive function (180, 10.8%). As previously reported, 7 there were no …”