A Leadless Intracardiac Transcatheter Pacing System

Chan, Kim H.; McGrady, Michele; Wilcox, Ian

doi:10.1056/nejmc1604852

Cited by 27 publications

(12 citation statements)

References 4 publications

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“…We found a high complication rate of 13.9% at 30 days, and a mortality rate of 9.6% at 6 months, 6% within 30 days and 3.6% more within 31-180 days of the procedure, much higher than any previous reported large study on CIED implantation or replacements out the setting of COVID-19 disease. 23 , 24 , 25 , 26 , 27 , 28 , 29 The higher complication rate seen in our cohort was likely related to the acute COVID-19 illness, the existence of high comorbidities rate and the fact that elective procedures on less sick patients may have been deferred. In addition, the use of PPE, reported by many operators to impair their ability to perform the procedure, could have contributed to the high complication rate, even though the difference between PPE types and complication rate did not reach statistical significance.…”

Section: Discussionmentioning

confidence: 75%

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Implantation of cardiac electronic devices in active COVID-19 patients: Results from an international survey

et al. 2022

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Background Cardiac implantable electronic device (CIED) implantation rates, as well as the clinical and procedural characteristics and outcomes in patients with known active COVID-19 are unknown. Objective To gather information regarding CIED procedures during active COVID-19, performed with personal protective equipment, based on an international survey. Methods Fifty-three centers from 13 countries across 4 continents provided information on 166 patients with known active COVID-19 who underwent a CIED procedure. Results CIED procedure rate in 133,655 hospitalized COVID-19 patients ranged from 0 to 16.2 per 1000 patients (p<0.001). Most devices were implanted due to high degree / complete AV block (112, 67.5%) or sick sinus syndrome (31, 18.7%). Of the166 patients surveyed, the 30-day complication rate was 13.9% and the 180-day mortality rate was 9.6%. One patient had a lethal outcome as a direct result of the procedure. Differences in patient and procedural characteristics and outcomes were found between Europe and North America. An older population (76.6 vs. 66 years, p<0.001) with a non-significant higher complication rate (16.5% vs. 7.7%, p=0.2) were observed in Europe, while a higher rate of critically ill patients (3.3% vs. 33.3%, p<0.001) and mortality (5% vs. 26.9%, p=0.002) were observed in North America. Conclusion CIED procedure rates during known active COVID-19 disease varied greatly from 0 to 16.2 per 1000 hospitalized COVID-19 patients worldwide. Patients with active COVID-19 infection who underwent CIED implantation had high complication and mortality rates. Operators should take into consideration these risks prior to proceeding with CIED implantation in active COVID-19 patients.

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Section: Discussionmentioning

confidence: 75%

“…Complications increased with older age, increase in comorbidities and non-elective procedures. 27 The Micra investigational device exemption (IDE) prospective study found device complications occurred in 3.4% of patient 28 , while real world data reported an even lower rate of 1.51%. 29 …”

Section: Discussionmentioning

confidence: 99%

Implantation of cardiac electronic devices in active COVID-19 patients: Results from an international survey

et al. 2022

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“…First, the World-wide Randomized Antibiotic EnveloPe Infection PrevenTion Trial (WRAP-IT) was a post-market, interventional clinical study that collected information between 2015 and 2018 related to Cardiac Implantable Electronic Device (CIED) infection complications 12 months after implantation [ 3 ]. Second, the Micra Investigational Device Exemption (IDE) study was an interventional study that collected information on implants of Micra ™ (Medtronic plc, Mounds View, MN, US), a leadless intracardiac transcatheter pacing system, and on adverse events 6 months after implantation between 2015 and 2017 [ 4 ]. Even though both studies enrolled patients worldwide, we used information only for patients enrolled in the US for whom UB-04s were available.…”

Section: Methodsmentioning

confidence: 99%

Collection of economic data using UB-04s: Is it worth the effort? Evidence from two clinical trials

Higuera

Ismyrloglou

et al. 2022

PLoS ONE

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Cost collection using UB-04 forms for economic evaluation is challenging, as UB-04 collection is time and effort intensive and compliance is imperfect. Alternative data sources could overcome those challenges. The objective of this study is to determine the usefulness of UB-04 data in estimating hospital costs compared to clinical case report form (CRF) data. Health care utilization costs were compared from financial information in UB-04s and from an assignment process using CRF data, from the WRAP-IT (23 infections) and the Micra IDE trials (61 adverse events and 108 implants). Charge-based costs were calculated by multiplying charges in UB-04s and hospital-specific Cost-to-Charge ratios from the Centers for Medicare and Medicaid Services cost reports. The cost assignment process used clinical information to find comparable encounters in real world data and assigned an average cost. Paired difference tests evaluated whether both methods yield similar results. The mean difference in total infection related costs between methods in the WRAP-IT trial was $152 +/-$22,565. In the Micra IDE trial, the mean difference in total adverse event related costs between methods was -$355 +/-$8,298 while the mean difference in total implant related costs between methods was $-3,488 +/-$13,859. Wilcoxon tests and generalized linear models could not reject the difference in costs between methods in the first two cases. Cost assignment methods achieve results similar to costs obtained through UB-04s, without the additional investment in time and effort. The use of UB-04 information for services that are not mature in a health care system may present unexpected challenges, necessitating a tradeoff with other methods of cost assignment.

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“…Since the MLP delivery system has a relatively large inner diameter, there is certain incidence (c. 4%) of serious adverse events. The most commonly seen and severe complication is cardiac perforation ( 2 ). Clinical manifestations vary according to the location, aperture size and the patient's blood coagulation state, and may include chest pain, dyspnea and/or tamponade.…”

Section: Introductionmentioning

confidence: 99%

Minimally invasive repair of iatrogenic right ventricular perforation guided by bedside contrast-enhanced ultrasound: A case report and literature review

Zhao

Hong

Bao-chun

et al. 2022

Front. Cardiovasc. Med.

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This case report involves a 93-year-old female patient with atrioventricular block and suffered right ventricular free wall perforation during installation of Micra Leadless Pacemaker (MLP). Pericardial tamponade occurred shortly, and we adopted pericardial catheter drainage as the primary emergency treatment. Considering the patient's physical conditions and leveraging the special treatment facilitates of the Intensive Care Unit (ICU), we tried a new emergency treatment approach. After putting the patient under intravenous anesthesia (no cardiac arrest), we made a small intercostal incision and performed bedside minimally invasive repair of right ventricular free wall perforation. It should be noted that ultrasound played a key role in pinpointing the breach and intraoperative guidance. We first used contrast-enhanced ultrasound (CEUS) to locate the breach. Then guided by bedside ultrasound, we accessed the perforation with the minimum incision size (5 cm). Our experience in this case may serve as a good reference in the emergency treatment for right ventricular free wall perforation.

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A Leadless Intracardiac Transcatheter Pacing System

Cited by 27 publications

References 4 publications

Implantation of cardiac electronic devices in active COVID-19 patients: Results from an international survey

Implantation of cardiac electronic devices in active COVID-19 patients: Results from an international survey

Collection of economic data using UB-04s: Is it worth the effort? Evidence from two clinical trials

Minimally invasive repair of iatrogenic right ventricular perforation guided by bedside contrast-enhanced ultrasound: A case report and literature review

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