A Leadless Intracardiac Transcatheter Pacing System Reynolds, Dwight; Duray, Gabor Z.; Omar, Razali ...
New England journal of medicine/The New England journal of medicine,
02/2016, Volume:
374, Issue:
6
Journal Article
Abstract
Aims
Clinical trials have demonstrated the safety and efficacy of the Micra leadless VVI pacemaker; however, longer-term outcomes in a large, real-world population with a contemporaneous ...comparison to transvenous VVI pacemakers have not been examined. We compared reinterventions, chronic complications, and all-cause mortality at 2 years between leadless VVI and transvenous VVI implanted patients.
Methods and results
The Micra Coverage with Evidence Development study is a continuously enrolling, observational, cohort study of leadless VVI pacemakers in the US Medicare fee-for-service population. Patients implanted with a leadless VVI pacemaker between March 9, 2017, and December 31, 2018, were identified using Medicare claims data linked to manufacturer device registration data (n = 6219). All transvenous VVI patients from facilities with leadless VVI implants during the study period were obtained directly from Medicare claims (n = 10 212). Cox models were used to compare 2-year outcomes between groups. Compared to transvenous VVI, patients with leadless VVI had more end-stage renal disease (12.0% vs. 2.3%) and a higher Charlson comorbidity index (5.1 vs. 4.6). Leadless VVI patients had significantly fewer reinterventions adjusted hazard ratio (HR) 0.62, 95% confidence interval (CI) 0.45–0.85, P = 0.003 and chronic complications (adjusted HR 0.69, 95% CI 0.60–0.81, P < 0.0001) compared with transvenous VVI patients. Adjusted all-cause mortality at 2 years was not different between the two groups (adjusted HR 0.97, 95% CI 0.91–1.04, P = 0.37).
Conclusion
In a real-world study of US Medicare patients, the Micra leadless VVI pacemaker was associated with a 38% lower adjusted rate of reinterventions and a 31% lower adjusted rate of chronic complications compared with transvenous VVI pacing. There was no difference in adjusted all-cause mortality at 2 years.
Graphical Abstract
Graphical Abstract
Pacemaker-related infections remain a constant concern due to increased risk of patient morbidity and mortality. Although transvenous pacemakers are expected to have an infection rate ranging from ...0.77% to 2.08%, no cases of leadless pacemaker infection have been reported in clinical trials enrolling more than 3000 patients. Many potential reasons why leadless pacemakers may be resistant to infection include the absence of a subcutaneous pocket and leads, reduced skin and glove contact, size, location, and device material. This review summarizes the current state of evidence regarding the apparent infection resistance of leadless pacemakers.
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Background:A global study designed to demonstrate the safety and efficacy of a transcatheter pacing system included 38 Japanese patients enrolled at 4 sites. Subgroup analysis to evaluate the ...performance of the leadless intracardiac transcatheter pacing system in Japanese patients was performed.Methods and Results:Safety and efficacy outcomes, patient and implant procedure characteristics, and patient and physician acceptability from the Japanese population were compared with those from outside Japan. Differences in patient characteristics, implant procedure characteristics and patient acceptability were observed. There were no major complications in Japanese patients and pacing thresholds remained low and stable throughout follow-up. There were no observable differences between Japanese patients and patients from outside Japan in the freedom from major complication rate at 12-months post-implant (100.0% vs. 95.7%, P=0.211) or physician acceptability.Conclusions:Although some differences in specific baseline characteristics, such as body size and pacing indication, and in implant procedure characteristics, including anticoagulation strategy and hospitalization period, were observed in the Japanese patients, transcatheter pacemaker performance was similar to that in the global trial. (Clinical Trial Registration: ClinicalTrials.gov ID NCT02004873.)
Abstract
Aims
This study compares clinical outcomes between leadless pacemakers (leadless-VVI) and transvenous ventricular pacemakers (transvenous ventricular permanent-VVI) in subgroups of patients ...at higher risk of pacemaker complications.
Methods and results
This study is based on the Micra Coverage with Evidence Development (CED) study. Patients from the Micra CED study were considered in a high-risk subgroup if they had a diagnosis of chronic kidney disease Stages 4–5 (CKD45), end-stage renal disease, malignancy, diabetes, tricuspid valve disease (TVD), or chronic obstructive pulmonary disease (COPD) 12 months prior to pacemaker implant. A pre-specified set of complications and reinterventions were identified using diagnosis and procedure codes. Competing risks models were used to compare reinterventions and complications between leadless-VVI and transvenous-VVI patients within each subgroup; results were adjusted for multiple comparisons. A post hoc comparison of a composite outcome of reinterventions and device complications was conducted. Out of 27 991 patients, 9858 leadless-VVI and 12 157 transvenous-VVI patients have at least one high-risk comorbidity. Compared to transvenous-VVI patients, leadless-VVI patients in four subgroups malignancy, HR 0.68 (0.48–0.95); diabetes, HR 0.69 (0.53–0.89); TVD, HR 0.60 (0.44–0.82); COPD, HR 0.73 (0.55–0.98) had fewer complications, in three subgroups diabetes, HR 0.58 (0.37–0.89); TVD, HR 0.46 (0.28–0.76); COPD, HR 0.51 (0.29–0.90)) had fewer reinterventions, and in four subgroups (malignancy, HR 0.52 (0.32–0.83); diabetes, HR 0.52 (0.35–0.77); TVD, HR 0.44 (0.28–0.70); COPD, HR 0.55 (0.34–0.89) had lower rates of the combined outcome.
Conclusion
In a real-world study, leadless pacemaker patients had lower 2-year complications and reinterventions rates compared with transvenous-VVI pacing in several high-risk subgroups.
Trial Registration
ClinicalTrials.gov ID NCT03039712
Graphical Abstract
Graphical Abstract
Introduction
The Micra Coverage with Evidence Development (CED) Study is a novel comparative analysis of Micra (leadless VVI) and transvenous single‐chamber ventricular pacemakers (transvenous VVI) ...using administrative claims data. To compare chronic complications, device reinterventions, heart failure hospitalizations, and all‐cause mortality after 3 years of follow‐up.
Methods
US Medicare claims data linked to manufacturer device registration information were used to identify Medicare beneficiaries with a de novo implant of either a Micra VR leadless VVI or transvenous VVI pacemaker from March 9, 2017 to December 31, 2018. Unadjusted and propensity score overlap‐weight adjusted Fine‐Gray competing risk models were used to compare outcomes at 3 years.
Results
Leadless VVI patients (N = 6219) had a 32% lower rate of chronic complications and a 41% lower rate of reintervention compared with transvenous VVI patients (N = 10 212) (chronic complication hazard ratio HR 0.68; 95% confidence interval CI, 0.59−0.78; reintervention HR 0.59; 95% CI 0.44−0.78). Infections rates were significantly lower among patients with a leadless VVI (<0.2% vs. 0.7%, p < .0001). Patients with a leadless VVI also had slightly lower rates of heart failure hospitalization (HR 0.90; 95% CI 0.84−0.97). There was no difference in the adjusted 3‐year all‐cause mortality rate (HR 0.97; 95% CI, 0.92−1.03).
Conclusion
This nationwide comparative evaluation of leadless VVI versus transvenous VVI de novo pacemaker implants demonstrated that the leadless group had significantly fewer complications, reinterventions, heart failure hospitalizations, and infections than the transvenous group at 3 years, confirming that the previously reported shorter‐term advantages associated with leadless pacing persist and continue to accrue in the medium‐to‐long‐term.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, SIK, UILJ, UKNU, UL, UM, UPUK, VSZLJ
Permanent cardiac pacing is the only effective treatment for symptomatic bradycardia, but complications associated with conventional transvenous pacing systems are commonly related to the pacing lead ...and pocket. We describe the early performance of a novel self-contained miniaturized pacemaker.
Patients having Class I or II indication for VVI pacing underwent implantation of a Micra transcatheter pacing system, from the femoral vein and fixated in the right ventricle using four protractible nitinol tines. Prespecified objectives were >85% freedom from unanticipated serious adverse device events (safety) and <2 V 3-month mean pacing capture threshold at 0.24 ms pulse width (efficacy). Patients were implanted (n = 140) from 23 centres in 11 countries (61% male, age 77.0 ± 10.2 years) for atrioventricular block (66%) or sinus node dysfunction (29%) indications. During mean follow-up of 1.9 ± 1.8 months, the safety endpoint was met with no unanticipated serious adverse device events. Thirty adverse events related to the system or procedure occurred, mostly due to transient dysrhythmias or femoral access complications. One pericardial effusion without tamponade occurred after 18 device deployments. In 60 patients followed to 3 months, mean pacing threshold was 0.51 ± 0.22 V, and no threshold was ≥2 V, meeting the efficacy endpoint (P < 0.001). Average R-wave was 16.1 ± 5.2 mV and impedance was 650.7 ± 130 ohms.
Early assessment shows the transcatheter pacemaker can safely and effectively be applied. Long-term safety and benefit of the pacemaker will further be evaluated in the trial.
ClinicalTrials.gov ID NCT02004873.
Background: The Micra leadless pacemaker has demonstrated favorable outcomes in global trials, but its real-world performance and safety in a Japan-specific population is unknown.Methods and Results: ...Micra Acute Performance (MAP) Japan enrolled 300 patients undergoing Micra VR leadless pacemaker implantation in 15 centers. The primary endpoint was the acute (30-day) major complication rate. The 30-day and 6-month major complication rates were compared to global Micra studies. All patients underwent successful implantation with an average follow-up of 7.23±2.83 months. Compared with previous Micra studies, Japanese patients were older, smaller, more frequently female, and had a higher pericardial effusion risk score. 11 acute major complications were reported in 10 patients for an acute complication rate of 3.33% (95% confidence interval: 1.61–6.04%), which was in line with global Micra trials. Pericardial effusion occurred in 4 patients (1.33%; 3 major, 1 minor). No procedure or device-related deaths occurred. Frailty significantly improved from baseline to follow-up as assessed by Japan Cardiovascular Health Study criteria.Conclusions: In a Japanese cohort, implantation of the Micra leadless pacemaker had a high success rate and low major complication rate. Despite the Japan cohort being older, smaller, and at higher risk, the safety and performance was in line with global Micra trials.
Device repositioning during Micra leadless pacemaker implantation may be required to achieve optimal pacing thresholds.
The purpose of this study was to describe the natural history of acute elevated ...Micra vs traditional transvenous lead thresholds.
Micra study VVI patients with threshold data (at 0.24 ms) at implant (n = 711) were compared with Capture study patients with de novo transvenous leads at 0.4 ms (n = 538). In both cohorts, high thresholds were defined as >1.0 V and very high as >1.5 V. Change in pacing threshold (0–6 months) with high (1.0 to ≤1.5 V) or very high (>1.5 V) thresholds were compared using the Wilcoxon signed-rank test.
Of the 711 Micra patients, 83 (11.7%) had an implant threshold of >1.0 V at 0.24 ms. Of the 538 Capture patients, 50 (9.3%) had an implant threshold of >1.0 V at 0.40 ms. There were no significant differences in patient characteristics between those with and without an implant threshold of >1.0 V, with the exception of left ventricular ejection fraction in the Capture cohort (high vs low thresholds, 53% vs 58%; P = .011). Patients with an implant threshold of >1.0 V decreased significantly (P < .001) in both cohorts. Micra patients with high and very high thresholds decreased significantly (P < .01) by 1 month, with 87% and 85% having 6-month thresholds lower than the implant value. However, when the capture threshold at implant was >2 V, only 18.2% had a threshold of ≤1 V at 6 months and 45.5% had a capture threshold of >2 V.
Pacing thresholds in most Micra patients with elevated thresholds decrease after implant. Micra device repositioning may not be necessary if the pacing threshold is ≤2 V.
BACKGROUND—The Lead Integrity Alert (LIA) was developed for Medtronic implantable cardioverter defibrillators to reduce inappropriate shocks for rapid oversensing caused by conductor fractures and ...reported for Medtronic Fidelis conductor fractures. The goal of this study was to compare the performance of LIA with conventional impedance monitoring for identifying lead system events (LSEs) and lead failures (LFs) in lead families that differ from Fidelis.
METHODS AND RESULTS—We analyzed data from 12 793 LIA enabled implantable cardioverter-defibrillator and lead combinations including 6123 St. Jude Riata or Durata, 5114 Boston Scientific Endotak, and 1556 Fidelis combinations followed in the CareLink remote monitoring network for LSEs and LFs. Each alert was adjudicated based on implantable cardioverter-defibrillator stored electrograms/diagnostics and clinical data as an LSE or non–lead system event by 2 physicians after reviewing the electrograms and clinical data. During 13 562 patient-years of LIA follow-up, there were 179 adjudicated alerts, of which 84 were LSEs (including 65 LFs) and 95 were non–lead system events. LIA identified >66% more LSE and >67% more LF compared with conventional impedance monitoring and did not differ by lead family for LSE (P=0.573) or LF (P=0.332). Isolated spikes on electrogram were associated more often with LF in St. Jude leads (71%) compared with Endotak (9%; P<0.001) and Fidelis leads (11%; P<0.001). The non–lead system event detection rate was different among lead families (P<0.001) ranging from 1 in every 78.5 years (Endotak), 228.9 years (St. Jude leads), and 627.6 years (Fidelis).
CONCLUSIONS—LIA markedly increased the detection rate of LSE compared with conventional impedance monitoring.
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