What question did this study set out to answer?

To compare the 30-day incidence of cardiac perforation and lead dislodgement between the CapSureFix MRI 5086 lead and the CapSureFix Novus 5076 non-MRI lead following pacemaker implantation.

January 1, 2016Journal of Korean Medical ScienceOpen Access

Complications of Cardiac Perforation and Lead Dislodgement with an MRI-Conditional Pacing Lead: a Korean Multi-Center Experience

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Permanent pacemaker implantation (n=482). Intervention: Medtronic CapSureFix MRI 5086 pacing lead vs. Medtronic CapSureFix Novus 5076 non-MRI pacing lead. Primary outcome: Incidence of cardiac perforation within 30 days after pacemaker implantation (p=0.084).

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Key result

The Medtronic CapSureFix MRI 5086 pacing lead was associated with a 1.4% incidence of cardiac perforation compared to 0% with the 5076 non-MRI lead, a difference that was not statistically significant.

Why the study?

Does the Medtronic CapSureFix MRI 5086 pacing lead increase the incidence of cardiac perforation and lead dislodgement compared to the 5076 non-MRI lead in patients undergoing pacemaker implantation?

Population

482 patients undergoing pacemaker implantation between March 2009 and September 2014 in a Korean nationwide…

Comparison

Medtronic CapSureFix MRI 5086 pacing lead vs Medtronic CapSureFix Novus 5076 non-MRI pacing…

Design

Cohort

Follow-up

30 days

Authors

CKChang Hee KwonUniversity of California, San Francisco JCJin Hee ChoiSeoul School of Integrated Sciences and Technologies JKJun KimSouthern Illinois University Carbondale

Discussion

Member takes

Implication

Caution advised with 5086 leads in elderly patients; leaves open whether MRI-conditional leads increase perforation risk.

Key Points

To compare the 30-day incidence of cardiac perforation and lead dislodgement between the CapSureFix MRI 5086 lead and the CapSureFix Novus 5076 non-MRI lead following pacemaker implantation.
Nationwide, multicenter retrospective study evaluating 482 patients who received either the 5086 lead (N=277) or the 5076 lead (N=205) between March 2009 and September 2014 in Korea.
Tracked adverse events occurring within 30 days of implantation and performed multivariate logistic regression to identify independent risk factors for complications.
Cardiac perforation within 30 days occurred in 4 patients (1.4%) with the 5086 lead and in 0 patients (0.0%) with the 5076 lead (P = 0.084).
Lead dislodgement occurred in 8 patients (2.9%) in the 5086 lead group and 5 patients (2.4%) in the 5076 lead group (P = 0.764).
Multivariate analysis showed age was significantly associated with cardiac perforation, while congestive heart failure and right atrial lead positioning at the free wall or septum were significant risk factors for lead dislodgement and revision.

Study Design

Type

Cohort (n=482)

Multicenter

Yes

Structured PICO

Does the Medtronic CapSureFix MRI 5086 pacing lead increase the incidence of cardiac perforation and lead dislodgement compared to the 5076 non-MRI lead in patients undergoing pacemaker implantation?

Population

482 adult patients undergoing permanent pacemaker implantation, followed for 30 days to assess acute lead complications.

Exposure

Medtronic CapSureFix MRI 5086 pacing lead

Comparator

Medtronic CapSureFix Novus 5076 non-MRI pacing lead

Outcome

Incidence of cardiac perforation and lead dislodgement within 30 days after pacemaker implantationsafety

Main Result

Absolute Event Rate: 1.4% vs 0%

p-value: p=0.084

The incidence of cardiac perforation and lead dislodgement within 30 days was not statistically different between the MRI-conditional 5086 lead and the non-MRI 5076 lead, though numerical differences in perforation suggest caution in elderly patients.

Limitations

Retrospective multicenter observational design
Different implant periods between the 5086 and 5076 leads
Potential learning curve with the handling of the newer 5086 lead

Cite This Study

Kwon et al. (2016) conducted a cohort in Permanent pacemaker implantation (n=482). Medtronic CapSureFix MRI 5086 pacing lead vs. Medtronic CapSureFix Novus 5076 non-MRI pacing lead was evaluated on Incidence of cardiac perforation within 30 days after pacemaker implantation (p=0.084). The Medtronic CapSureFix MRI 5086 pacing lead was associated with a 1.4% incidence of cardiac perforation compared to 0% with the 5076 non-MRI lead, a difference that was not statistically significant.

synapsesocial.com/papers/6a81a37aa2b9faa7beb6c028 https://doi.org/10.3346/jkms.2016.31.9.1397

Topics

Heart failure HFrEF treatment

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Complications of Cardiac Perforation and Lead Dislodgement with an MRI-Conditional Pacing Lead: a Korean Multi-Center Experience

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Topics

Complications of Cardiac Perforation and Lead Dislodgement with an MRI-Conditional Pacing Lead: a Korean Multi-Center Experience

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Also Consider

Topics

Also Consider