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Follow-up of patients with new cardiovascular implantable electronic devices: are experts' recommendations implemented in routine clinical practice?

ABSTRACT: A 2008 expert consensus statement outlined the minimum frequency of follow-up of patients with cardiovascular implantable electronic devices (CIEDs).We studied 38 055 Medicare beneficiaries who received a new CIED between January 1, 2005, and June 30, 2009. The main outcome measure was variation of follow-up by patient factors and year of device implantation. We determined the number of patients who were eligible for and attended an in-person CIED follow-up visit within 2 to 12 weeks, 0 to 16 weeks, and 1 year after implantation. Among eligible patients, 42.4% had an initial in-person visit within 2 to 12 weeks. This visit was significantly more common among white patients than black patients and patients of other races (43.0% versus 36.8% versus 40.5%; P<0.001). Follow-up within 2 to 12 weeks improved from 40.3% in 2005 to 55.1% in 2009 (P<0.001 for trend). The rate of follow-up within 0 to 16 weeks was 65.1% and improved considerably from 2005 to 2009 (62.3%-79.6%; P<0.001 for trend). Within 1 year, 78.0% of the overall population had at least 1 in-person CIED follow-up visit.Although most Medicare beneficiaries who received a new CIED between 2005 and 2009 did not have an initial in-person CIED follow-up visit within 2 to 12 weeks after device implantation, the rate of initial follow-up improved appreciably over time. This CIED follow-up visit was significantly more common in white patients than in patients of other races.

SUBMITTER: Al-Khatib SM

PROVIDER: S-EPMC3640354 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature

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Follow-up of patients with new cardiovascular implantable electronic devices: are experts' recommendations implemented in routine clinical practice?

Al-Khatib Sana M SM Mi Xiaojuan X Wilkoff Bruce L BL Qualls Laura G LG Frazier-Mills Camille C Setoguchi Soko S Hess Paul L PL Curtis Lesley H LH

Circulation. Arrhythmia and electrophysiology 20121223 1

<h4>Background</h4>A 2008 expert consensus statement outlined the minimum frequency of follow-up of patients with cardiovascular implantable electronic devices (CIEDs).<h4>Methods and results</h4>We studied 38 055 Medicare beneficiaries who received a new CIED between January 1, 2005, and June 30, 2009. The main outcome measure was variation of follow-up by patient factors and year of device implantation. We determined the number of patients who were eligible for and attended an in-person CIED f ...[more]

PMID: 23264436

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Project description:BackgroundCapacity to deliver outpatient care for patients with cardiac implantable electronic devices (CIEDs) may soon be outweighed by need. This systematic review aims to investigate the comparative effectiveness, safety, and cost for virtual or remote clinic interventions for patients with CIEDs and explores how outcomes may be influenced by patient or system factors in-depth.MethodsWe will perform a systematic literature search in MEDLINE, Embase, PsycINFO, CINAHL, Proquest Dissertations & Theses, other EBM Reviews, and trial registry databases. Two authors will independently screen titles and abstracts for eligibility. We will include randomized and non-randomized controlled trials, quasi-randomized and experimental studies, cohort, and case-control studies. Study populations of interest are individuals with a CIED (pacemaker, ICD, CRT). Eligibility will be restricted to virtual or remote follow-up or care interventions compared to any other approach. The co-primary outcomes of interest are mortality and patient satisfaction. Secondary outcomes include clinical effectiveness (e.g., ICD shock, time-to-detection of medical event, hospitalizations), safety (e.g., serious or device-related adverse events), device efficacy (e.g., transmissions, malfunctions), costs, workflow (e.g., resources, process outcomes, time-saved), and patient reported (e.g., burden, quality of life). Data will be extracted by one author and checked by a second using a standardized template. We will use published frameworks to capture data relevant to intervention effects that may be influenced by intervention definition or complexity, context and setting, or in socially disadvantaged populations. Detailed descriptive results will be presented for all included studies and outcomes, and where feasible, synthesized using meta-analysis. Risk of bias will be assessed by two review authors independently using Cochrane Risk of Bias tools. Certainty of evidence will be assessed using the GRADE approach.DiscussionIncreases in number of CIEDs implanted, combined with an aging population and finite health resource allocations at the system-level may lead to increased reliance on virtual follow-up or care models in the future. These models must prioritize consistent, equitable, and timely care as a priority. Results from this systematic review will provide important insight into the potential contextual factors which moderate or mediate the effectiveness, safety, and cost of virtual follow-up or care models for patients.Systematic review registrationPROSPERO registration number CRD42020145210.

Project description:BackgroundVirtual care models are used to follow-up patients with cardiovascular implantable electronic devices (CIED), including pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization therapy. There is increasing interest in the expansion of virtual, or even remote-only, CIED care models to alleviate resource and economic burden to both patients and specialty device clinics and to maintain or improve equity and access to high-quality cardiovascular care. This qualitative framework synthesis aims to identify barriers and enablers to virtual care models from both the perspective of the patient and device clinics. How setting, context, equity factors or other aspects influence these factors, or satisfaction with care, will also be investigated.MethodsWe will perform a systematic literature search in MEDLINE, Embase, PsycINFO, CINAHL, Proquest Dissertations & Theses, other EBM Reviews, and trial registry databases. Screening will be completed by two independent review authors. Original research articles having a qualitative component (i.e., qualitative, mixed-, or multi-method) are eligible. Study populations of interest are (a) individuals with a CIED or (b) healthcare providers involved in any aspect of virtual or remote follow-up of patients with CIEDs. Eligibility will be restricted to studies published after January 1, 2000 in English or French. Data will be captured using standardized templates based on the domains and constructs of the Theoretical Domains Framework and the Warwick Patient Experiences Framework. The Joanna Briggs Institute Critical Appraisal Checklist for Qualitative Research will be applied to all included studies. The GRADE-CERQual approach will be applied to assess and summarize confidence in key findings. Reporting will follow the enhancing transparency in reporting the synthesis of qualitative research (ENTREQ) statement. Detailed descriptive results will be presented, and summary of qualitative findings tables will be produced.DiscussionWhile a number of trials have captured the clinical effectiveness and safety of virtual follow-up for CIEDs, there has been less attention given to factors affecting use and implementation of remote care by patients and healthcare providers or satisfaction with care. Results from this qualitative framework synthesis will provide important lived experience data from both patients and healthcare providers which will be essential to incorporate in clinical guidelines.Systematic review registrationPROSPERO CRD42020160533.

Project description:Alemtuzumab (Lemtrada™) is a humanized monoclonal antibody approved in more than 50 countries. Within the European Union, alemtuzumab is indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features; in the USA, the indication states that alemtuzumab should generally be reserved for the treatment of patients with relapsing forms of multiple sclerosis who have had an inadequate response to two or more disease-modifying therapies (DMTs). In clinical trials, alemtuzumab demonstrated efficacy in treatment-naïve patients with active RRMS and those relapsing on prior DMTs, with a consistent and manageable safety and tolerability profile. The European Union indication provides physicians with significant flexibility regarding treatment decisions, affording the opportunity for individualized treatment. Thus, alemtuzumab may be an appropriate treatment choice across a broad range of patients with RRMS, including, for example, treatment-naïve patients with active disease, patients with highly active disease, or for patients relapsing on prior DMTs. There are several practicalities to consider when using alemtuzumab, including the unique dosing regimen, administered via intravenous infusion on 5 consecutive days at baseline and on 3 consecutive days 12 months later, and as-needed retreatment (3 consecutive days at least 12 months after the last course) in cases of disease recurrence. Additionally, routine monthly monitoring is required for up to 48 months after the last infusion to promptly identify potentially serious autoimmune adverse events. Given these considerations, it is beneficial to gain insight into how alemtuzumab is being used in the real-world clinical setting. Here, we report recommendations from European multiple sclerosis experts regarding best practices for alemtuzumab treatment, including management of adverse events and compliance with ongoing safety monitoring requirements.

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Follow-up of patients with new cardiovascular implantable electronic devices: are experts' recommendations implemented in routine clinical practice?

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Follow-up of patients with new cardiovascular implantable electronic devices: are experts' recommendations implemented in routine clinical practice?

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