ABSTRACT
About 4.5-20% of patients after heart transplant require pacemaker (PM) implantation. The high infective risk profile and the low probability of pacing dependency make heart-transplanted patients the ideal candidates for a leadless single-chamber PM. We report the first multicenter experience of leadless PM implantation in a series of heart-transplanted patients with a long-term follow-up. Our data confirm the feasibility and acceptable safety of leadless device in this peculiar kind of patients, despite implantation seems to be slightly more challenging with respect to non-transplanted patients. Although more data are required, a leadless single-chamber surveillance PM seems a valuable option for heart-transplanted patients.
Subject(s)
Heart Transplantation , Pacemaker, Artificial , Arrhythmias, Cardiac/therapy , Electrocardiography , Equipment Design , Humans , Treatment OutcomeABSTRACT
BACKGROUND: Despite an intensive search for predictors of the response to cardiac resynchronization therapy (CRT), the QRS duration remains the simplest and most robust predictor of a positive response. QRS duration of ≥ 130 ms is considered to be a prerequisite for CRT; however, some studies have shown that CRT may also be effective in heart failure (HF) patients with a narrow QRS (<130 ms). Since CRT can now be performed by pacing the left ventricle from multiple vectors via a single quadripolar lead, it is possible that multipoint pacing (MPP) might be effective in HF patients with a narrow QRS. This article reports the design of the MPP Narrow QRS trial, a prospective, randomized, multicenter, controlled feasibility study to investigate the efficacy of MPP using two LV pacing vectors in patients with a narrow QRS complex (100-130 ms). METHODS: Fifty patients with a standard ICD indication will be enrolled and randomized (1:1) to either an MPP group or a Standard ICD group. All patients will undergo a low-dose dobutamine stress echo test and only those with contractile reserve will be included in the study and randomized. The primary endpoint will be the percentage of patients in each group that have reverse remodeling at 12 months, defined as a reduction in left ventricular end-systolic volume (LVESV) of >15% from the baseline. DISCUSSION: This feasibility study will determine whether MPP improves reverse remodeling, as compared with standard ICD, in HF patients who have a narrow QRS complex (100-130 ms). TRIAL REGISTRATION: ClinicalTrials.gov, NCT02402816 . Registered on 25 March 2015.
Subject(s)
Cardiac Pacing, Artificial , Clinical Protocols , Defibrillators, Implantable , Electrocardiography , Research Design , Cardiac Resynchronization Therapy , Heart Failure/physiopathology , Heart Failure/therapy , Humans , Pilot Projects , Prospective StudiesABSTRACT
A large number of studies have demonstrated that remote control of implantable devices (home monitoring, HM) is beneficial for patients, as it allows strict and tailored controls with earlier identification of potential problems, by avoiding unnecessary visits. HM is also beneficial for hospitals, as it progressively reduces the resources necessary for routine controls and contributes to a better management of critical patients. According to current European and Italian guidelines, HM can replace standard ambulatory monitoring, thereby decreasing the number of outpatient visits for each individual patient (it is possible to schedule a comprehensive clinical evaluation at 1 year rather than every 6-8 months, while performing controls at 1 and 3 months by remote transmission). At present, however, reimbursement of HM services is not covered by the National Health System and, as a consequence, cannot be performed as an institutional activity within the hospital. In addition, many critical issues remain to be resolved before the HM system can be fully implemented into daily clinical management, particularly in patients with heart failure at higher risk for sudden cardiac death.
