Customer Communications
Procedure Education Brief: Micra TPS Implant

Procedure Education Brief: Micra TPS Implant

Micra TPS devices
Original Date of Communication: November 2021

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Overview

This Medtronic Procedure Education Brief provides a reminder of specific implant procedure safety recommendations included in the current labeling for Micra™ VR and Micra™ AV Transcatheter Pacing System (TPS) specifically from the Micra Instructions for Use (IFU) and the Micra implanter training program.  Following instructions provided in the IFU and implanter training can reduce the risk of cardiac perforation, especially considerations for delivery system steering, repositioning the device, and patient selection.

Micra IFU and Implant Procedure Training

The Micra IFU is available on the Medtronic electronic manuals website (https://manuals.medtronic.com/manuals/main/region). Implanter training material for implanters who have attended training, and been certified to implant Micra TPS, can be found on the Medtronic Academy website ( https://www.medtronicacademy.com/products/micra-transcatheter-pacing-systems-overview-and-training).  These instructional materials provide recommendations that limit implant complications such as:

  • patient selection considerations to minimize perforation risk
  • steering the delivery system with the use of fluoroscopy
  • identifying implant location at the right ventricular septum with the use of contrast-enhanced fluoroscopy
  • confirming position on the septum with contrast-enhanced fluoroscopy prior to deployment
  • considerations for repositioning the device
  • ensuring attending staff are prepared to manage pericardial effusion and tamponade, including immediate access to echocardiography equipment and availability of a pericardiocentesis kit
  • recognizing clinical signs and symptoms of pericardial effusion and tamponade in order to minimize clinical response time
  • preparedness for cardiac surgical intervention

Micra Safety and Effectiveness Data

On 17 November 2021, the US FDA posted a Letter to Healthcare Providers (Leadless Pacing Systems: Risk of Major Complications Related to Cardiac Perforation During Implantation - Letter to Health Care Providers) reminding physicians about the rare but possible risk of cardiac perforations associated with leadless pacemaker implantation. They reiterated the specific recommendations from Medtronic Micra implant training and IFU (reviewed above).   This communication can be found here: https://www.fda.gov/medical-devices/medical-device-safety/letters-health-care-providers.

While regulatory agencies and Micra implanters are aware that cardiac perforation is a known risk, the FDA Letter to Healthcare Providers included data for which implanters may be seeking additional context.  The letter indicated that risk of cardiac perforation between transvenous pacing implants and Micra implants are similar, and that Micra implant complication rates are within expectations. The letter also indicated that in some scenarios, when a perforation occurs with a Micra implant procedure, the severity of the perforation complications can be higher than when a perforation occurs with a transvenous implant procedure.

Data from our Global Complaint Handling database suggests that the Micra rate of perforation is 0.6% and the rate of perforation related death is 0.13% out of over 100,000 implants worldwide.  The Micra real-world perforation rate is in-line with, or lower than, the perforation rate observed in pre-market or post-market clinical studies1.

Since Micra received pre-market approval in 2016, Medtronic has continuously monitored its safety and effectiveness.  Multiple studies have shown that Micra has a high rate of implant success (exceeding 99%)2,3. Additionally, in the global Micra Investigational Device Exemption (IDE) Trial, Micra has been shown to reduce the risk for major complications compared to transvenous implants (through 12-months) by 48%2, and in the global Micra Post Approval Registry by 63%3.

Medtronic is further assessing the outcomes of Micra in the Micra Coverage with Evidence Development (CED) Study, which is a continuously enrolling, observational, cohort study evaluating complications, utilization, and outcomes of Micra.

Recent publications from the Micra CED Study in July 20214 and November 20215 based on 5,746 Micra patients and 9,622 with contemporaneously implanted transvenous single-chamber pacing patients show that at time of implant, Micra patients tend to be sicker than the transvenous single-chamber pacemaker population.  Micra patients have a higher comorbidity burden as measured by the Charlson comorbidity index (5.1 vs 4.6, P<0.001) and a higher rate of end stage renal disease (12.0% vs 2.3%, P<0.001)4.  Acute and longer-term outcomes reported in these publications are shown in the table below.

Measure

Unadjusted Results
 

(Micra vs Transvenous-VVI)

Results Adjusted for Patient
Medical History

(Micra vs Transvenous-VVI)

Acute (30-day) device-related complications including dislodgement, infection, pocket complications4

1.4% vs 2.6% (P<0.001)

1.4% vs 2.5% (P<0.001)

Total acute (30-day) complications4

8.4% vs 7.3%(P=0.02)

7.7% vs 7.4% (P=0.49)

Cardiac perforation/effusion4

0.8% vs 0.4% (P<0.001)

0.8% vs 0.4% (P<0.001)

30-day all-cause mortality5

4.4% vs 3.8% (P=0.10)

4.0% vs 4.4% (P=0.60)

2-year reintervention rate5

3.0% vs 4.8% (P=0.006)

3.1% vs 4.9% (P=0.003)

2-year chronic complications5

4.9% vs 6.5% (P<0.001)

4.6% vs 6.5% (P<0.001)

2-year all-cause mortality5

34.0% vs 31.6% (P=0.002)

31.4% vs 32.5% (P=0.37)

 

Medtronic monitors and evaluates product performance and publishes device performance data on our product performance website http://productperformance.medtronic.com. In addition, Medtronic continues to collaborate with physicians and regulatory agencies to improve patient outcomes and clinical experience as part of our dedication to patient safety and product effectiveness.

_______________________________________
1 Micra IDE: 1.8% (13/726), Micra post-approval registry 0.8% (15/1811), Micra Coverage with Evidence Development 0.8% (47/5746)
2 Reynolds et al. NEJM 2016; 374(6): 533-541.
3 El-Chami et al. Heart Rhythm 2018; 15(12): 1800-1807.
4 Piccini et al. JAMA Cardiology 2021; 6(10): 1187-1195.
5 El-Chami et al. EHJ 2021; ePub ahead of print
 


Specific Models This Applies To

www.medtronic.com/productperformance 851050