Aatish Garg1, Jayanthi N Koneru1, Dedra H Fagan2, Kurt Stromberg2, Santosh K Padala1, Mikhael F El-Chami3, Paul R Roberts4, Jonathan P Piccini5, Alan Cheng2, Kenneth A Ellenbogen6. 1. Department of Cardiac Electrophysiology, Virginia Commonwealth University/Pauley Heart Center, Richmond, Virginia. 2. Medtronic, Mounds View, Minnesota. 3. Emory University, Atlanta, Georgia. 4. University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom. 5. Duke Center for Atrial Fibrillation and Electrophysiology Section and Duke Clinical Research Institute, Durham, North Carolina. 6. Department of Cardiac Electrophysiology, Virginia Commonwealth University/Pauley Heart Center, Richmond, Virginia. Electronic address: kenneth.ellenbogen@vcuhealth.org.
Abstract
BACKGROUND: The Micra transcatheter pacemaker is a safe and effective alternative to transvenous permanent pacemakers (TV-PPMs). However, the safety profile and mortality outcomes of Micra implantation in patients deemed poor candidates for TV-PPM are incompletely understood. OBJECTIVE: The purpose of this study was to evaluate safety and all-cause mortality in patients undergoing Micra implantation stratified by whether they were precluded for therapy with a TV-PPM. METHODS: Patients from the Micra clinical trials were divided into groups on the basis of whether the implanter considered the patient to be precluded from receiving a TV-PPM. Micra groups were compared with one another as well as with a historical cohort of patients who received a single-chamber TV-PPM. RESULTS: A total of 2817 patients underwent a Micra implantation attempt, of whom 546 (19%) patients deemed ineligible for TV-PPM implantation for reasons such as venous access issues or prior device infections. Both acute mortality (2.75% vs 1.32%; P=.022) and total mortality at 36 months (38.1% vs 20.6%; P<.001) were significantly higher in the precluded group than in the nonprecluded group. Mortality was similar among nonprecluded patients and patients implanted with a TV-PPM. The major complication rate through 36 months was similar between the 2 Micra groups (3.81% vs 4.30%; P=.40). CONCLUSION: All-cause mortality is higher in Micra patients deemed ineligible for TV-PPM implantation than in nonprecluded Micra patients and those who received a TV-PPM, in part related to a higher incidence of chronic comorbidities in these patients. The overall major complication rate was low and did not differ by preclusion status. CLINICAL TRIAL REGISTRATION: Micra Post-Approval Registry ClinicalTrials.gov identifier: NCT02536118; Micra Continued Access Study ClinicalTrials.gov identifier: NCT02488681; Micra Transcatheter Pacing Study ClinicalTrials.gov identifier: NCT02004873; Medtronic Product Surveillance Registry ClinicalTrials.gov identifier: NCT01524276.
BACKGROUND: The Micra transcatheter pacemaker is a safe and effective alternative to transvenous permanent pacemakers (TV-PPMs). However, the safety profile and mortality outcomes of Micra implantation in patients deemed poor candidates for TV-PPM are incompletely understood. OBJECTIVE: The purpose of this study was to evaluate safety and all-cause mortality in patients undergoing Micra implantation stratified by whether they were precluded for therapy with a TV-PPM. METHODS:Patients from the Micra clinical trials were divided into groups on the basis of whether the implanter considered the patient to be precluded from receiving a TV-PPM. Micra groups were compared with one another as well as with a historical cohort of patients who received a single-chamber TV-PPM. RESULTS: A total of 2817 patients underwent a Micra implantation attempt, of whom 546 (19%) patients deemed ineligible for TV-PPM implantation for reasons such as venous access issues or prior device infections. Both acute mortality (2.75% vs 1.32%; P=.022) and total mortality at 36 months (38.1% vs 20.6%; P<.001) were significantly higher in the precluded group than in the nonprecluded group. Mortality was similar among nonprecluded patients and patients implanted with a TV-PPM. The major complication rate through 36 months was similar between the 2 Micra groups (3.81% vs 4.30%; P=.40). CONCLUSION: All-cause mortality is higher in Micrapatients deemed ineligible for TV-PPM implantation than in nonprecluded Micrapatients and those who received a TV-PPM, in part related to a higher incidence of chronic comorbidities in these patients. The overall major complication rate was low and did not differ by preclusion status. CLINICAL TRIAL REGISTRATION: Micra Post-Approval Registry ClinicalTrials.gov identifier: NCT02536118; Micra Continued Access Study ClinicalTrials.gov identifier: NCT02488681; Micra Transcatheter Pacing Study ClinicalTrials.gov identifier: NCT02004873; Medtronic Product Surveillance Registry ClinicalTrials.gov identifier: NCT01524276.
Authors: Gerald Drożdż; Bruno Hrymniak; Bartosz Biel; Przemysław Skoczyński; Wiktoria Drożdż; Dorota Zyśko; Waldemar Banasiak; Dariusz Jagielski Journal: Int J Environ Res Public Health Date: 2022-05-23 Impact factor: 4.614
Authors: Jonathan P Piccini; Ryan Cunnane; Jan Steffel; Mikhael F El-Chami; Dwight Reynolds; Paul R Roberts; Kyoko Soejima; Clemens Steinwender; Christophe Garweg; Larry Chinitz; Christopher R Ellis; Kurt Stromberg; Dedra H Fagan; Lluis Mont Journal: Europace Date: 2022-07-21 Impact factor: 5.486