Regional variations in baseline characteristics of cardiac rhythm device recipients: The PANORAMA observational cohort study

Q: What are the key findings of this study?

Cardiac rhythm management device recipients exhibited significant regional variation in baseline characteristics, including higher diabetes rates in the Middle East (47%, p<0.001 vs all).

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Cardiac rhythm disorders requiring cardiac rhythm management (CRM) device implantation (n=8586). Intervention: Geographical region of cardiac rhythm management (CRM) device implantation vs. Comparisons across 6 geographical regions (Eastern Europe, Western Europe, South Africa, Middle East, Latin America, India). Primary outcome: Regional variations in baseline clinical characteristics, comorbidities (e.g., diabetes prevalence), and implant practices (p=<0.001).

Q: What does this research mean for the field?

Recipients of cardiac rhythm management devices exhibit significant regional variations in baseline clinical characteristics, comorbidity profiles, and device implantation practices across global populations. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Q: What question did this study set out to answer?

To evaluate global regional differences in baseline demographics, clinical comorbidities, and implantation practices among patients receiving cardiac rhythm management devices.

Fawziah Al Kandari; Andrejs Ērglis; Raed Sweidan; Ingrid Dannheimer; Milan Sepši; Juan M. Bénézet; Michal Paďour; Ajay Madhukar Naik; Jaime Escudero; Teena M. West; Reece Holbrook; Faizel Lorgat

doi:10.1016/j.ijchv.2014.06.008

July 6, 2014IJC Heart & VesselsOpen Access

Regional variations in baseline characteristics of cardiac rhythm device recipients: The PANORAMA observational cohort study

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Key result

Middle East cardiac device recipients show distinct baseline profiles, led by ~47% diabetes prevalence.

P<0.001
n=8,586

Why the study?

The study was designed to collect concurrent data on subjects implanted with cardiac rhythm management devices from different worldwide regions not typically reported in the literature.

How do baseline clinical characteristics, comorbidities, and implantation practices vary across different global regions in patients receiving cardiac rhythm management devices?

Key Points

To evaluate global regional differences in baseline demographics, clinical comorbidities, and implantation practices among patients receiving cardiac rhythm management devices.
Prospective, multicenter observational cohort study evaluating baseline data from 8,586 subjects implanted with cardiac rhythm management (CRM) devices across 156 centers in 34 countries within 6 geographical regions between 2005 and 2011.
Implanted devices analyzed included pacemakers (IPG, 66% [n=5,592]), implantable cardioverter-defibrillators (ICD, 16% [n=1,407]), cardiac resynchronization therapy (CRT, 17% [n=1,455]), and implantable loop recorders or missing device type (<1% to 2% [n=132]).
Diabetes prevalence was substantially higher among subjects in the Middle East (47%) compared with India (33%), Western Europe (25%), Eastern Europe (20%), Latin America (19%), and South Africa (15%; p < 0.001 for Middle East vs all).
Atrial fibrillation was reported significantly more often in Eastern Europe (42%, p < 0.001 vs all) and Western Europe (36%, p < 0.05 vs all) than in South Africa (26%), Latin America (15%), the Middle East (15%), and India (9%).
Across all regions, men were more likely to smoke than women (46% vs 11%, p < 0.001), and the proportion of males receiving CRT devices ranged from 55% in India to 83% in Eastern Europe.

Study Design

Type

Cohort (n=8,586)

Multicenter

Yes

Structured PICO

How do baseline clinical characteristics, comorbidities, and implantation practices vary across different global regions in patients receiving cardiac rhythm management devices?

P

Population

8,586 patients implanted with Medtronic cardiac rhythm management devices (65% IPG, 16% ICD, 17% CRT) across 156 centers in 34 countries across 6 geographical regions, assessed at baseline and followed for at least 1 year.

E

Exposure

Implantation of a Medtronic market-released cardiac rhythm management device (single or dual chamber IPG, ICD, CRT-P, CRT-D, or implantable loop recorder) and standard clinical management across 6 geographical regions.

C

Comparator

Cross-regional comparison across the 6 geographical cohorts (Eastern Europe [n=2,496], Western Europe [n=1,497], Middle East [n=1,463], South Africa [n=1,432], Latin America [n=1,127], and India [n=571]).

O

Outcome

Baseline patient demographics, disease comorbidities, device indications, and implantation procedures/techniques stratified by geographical region and device cohort.

Main Result

p-value: p=<0.001

This large global registry demonstrates substantial regional heterogeneity in baseline comorbidities, demographics, and implant practices among cardiac rhythm device recipients in underrepresented and emerging geographies, which may impact real-world clinical outcomes compared to Western clinical trials.

Limitations

Single-manufacturer sponsored study (Medtronic), which might limit applicability across all device manufacturers
Some regions of the world (such as North America) were not represented
Number of centers and countries may not be sufficient to accurately characterize full regional practice and some differences could be center-specific
Some countries limited the type of device enrolled, preventing broad conclusions about the proportion of IPG/ICD/CRT use
Missing data and lack of specific quantitative definitions for some baseline patient conditions (e.g., hypertension)
No statistical adjustments were made for multiple comparisons
Single-manufacturer sponsored study where specific device characteristics might limit applicability across all device manufacturers
Some regions of the world were not represented
Number of centers and countries represented may not be sufficient to accurately characterize full regional practice and some differences could be center specific
Some countries limited the type of device enrolled, so broad conclusions about the proportion of IPG/ICD/CRT use are not possible
Missing data and lack of specific definitions for some patient conditions (e.g., hypertension)
No adjustments were made for multiple comparisons

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Implication

Regional differences may influence device recipient management; extends global registry data but leaves outcome effects open.

Abstract

BACKGROUND: The PANORAMA study was designed to collect concurrent data on subjects from different worldwide regions implanted with CRM devices. METHODS: In this prospective, multi-center study, we analyzed baseline data on 8586 subjects implanted with CRM devices with no additional selection criteria (66% pacemaker (IPG), 16% implantable cardiac defibrillators (ICD), 17% cardiac resynchronization therapy (CRT) and < 1% Internal Loop Recorder) from 156 hospitals across 6 geographical regions between 2005 and 2011. RESULTS: Regardless of the device implanted, subjects from the Middle East and India often had more diabetes than other regions. Eastern and Western Europe had higher rates of atrial fibrillation reported, and men were more likely to smoke than women (46% vs 11%, p < 0.001). Within the CRT cohort there was significant variation in the proportion of males receiving a device, ranging from 55% in India to 83% in Eastern Europe. CONCLUSIONS: We provide comprehensive descriptive data on patients receiving CRM devices from a range of geographies that are not typically reported in literature. We found significant variations in clinical characteristics and implant practices. Long term follow-up data will help evaluate if these variations require adjustments to outcome expectations.

Discussion

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Cite This Study

Kandari et al. (2014) conducted a cohort in Cardiac rhythm disorders requiring cardiac rhythm management (CRM) device implantation (n=8,586). Geographical region of cardiac rhythm management (CRM) device implantation vs. Comparisons across 6 geographical regions (Eastern Europe, Western Europe, South Africa, Middle East, Latin America, India) was evaluated on Regional variations in baseline clinical characteristics, comorbidities (e.g., diabetes prevalence), and implant practices (p=<0.001). Cardiac rhythm management device recipients exhibited significant regional variation in baseline characteristics, including higher diabetes rates in the Middle East (47%, p<0.001 vs all).

synapsesocial.com/papers/6ae9d45ded832a12efc130f4 https://doi.org/10.1016/j.ijchv.2014.06.008

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Regional variations in baseline characteristics of cardiac rhythm device recipients: The PANORAMA observational cohort study

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Regional variations in baseline characteristics of cardiac rhythm device recipients: The PANORAMA observational cohort study

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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