Long-term performance of a transcatheter pacing system: 12-Month results from the Micra Transcatheter Pacing Study

Duray, Gabor Z.; Ritter, Philippe; El‐Chami, Mikhael F.; Narasimhan, Calambur; Omar, Razali; Tolosana, José Marı́a; Zhang, Shu; Soejima, Kyoko; Steinwender, Clemens; Rapallini, Leonardo; Cicic, Aida; Fagan, Dedra H.; Li, Shufeng; Reynolds, Dwight

doi:10.1016/j.hrthm.2017.01.035

Cited by 257 publications

(210 citation statements)

References 16 publications

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“…Leadless pacemakers eliminate pocket‐related infections and have the potential to reduce lead‐related endocarditis. In the Micra leadless pacemaker investigational device exemption (IDE) study and post approval registry (PAR) no Micra device‐related infections or any infections requiring device removal were observed . Hence, Micra in the setting of device infection might be an appealing pacing alternative after CIED removal.…”

Section: Introductionmentioning

confidence: 99%

Leadless pacemaker implant in patients with pre‐existing infections: Results from the Micra postapproval registry

El‐Chami

Johansen

Zaidi

et al. 2019

Cardiovasc electrophysiol

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114

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IntroductionLeadless pacemakers may provide a safe and attractive pacing option to patients with cardiac implantable electronic device (CIED) infection. We describe the characteristics and outcomes of patients with a recent CIED infection undergoing Micra implant attempt.Methods and ResultsPatients with prior CIED infection and device explant with Micra implant within 30 days, were identified from the Micra post approval registry. Procedure characteristics and outcomes were summarized. A total of 105 patients with prior CIED infection underwent Micra implant attempt ≤30 days from prior system explant (84 [80%] pacemakers and 13 [12%] ICD/CRT‐D). All system components were explanted in 93% of patients and explant occurred a median of 6 days before Micra implant, with 37% occurring on the day of Micra implant. Micra was successfully implanted in 99% patients, mean follow‐up duration was 8.5 ± 7.1 months (range 0‐28.5). The majority of patients (91%) received IV antibiotics preimplant, while 42% of patients received IV antibiotics postprocedure. The median length of hospitalization following Micra implant was 2 days (IQR, 1‐7). During follow‐up, two patients died from sepsis and four patients required system upgrade, of which two patients received Micra to provide temporary pacing support. There were no Micra devices explanted due to infection.ConclusionImplantation of the Micra transcatheter pacemaker is safe and feasible in patients with a recent CIED infection. No recurrent infections that required Micra device removal were seen. Leadless pacemakers appear to be a safe pacing alternative for patients with CIED infection who undergo extraction.

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Section: Introductionmentioning

confidence: 99%

Leadless pacemaker implant in patients with pre‐existing infections: Results from the Micra postapproval registry

El‐Chami

Johansen

Zaidi

et al. 2019

Cardiovasc electrophysiol

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114

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“…Leadless pacemakers eliminate the need for a subcutaneous pocket and associated generator pocket infections. Interestingly, no cases of hematogenous device infections were seen either in any of the leadless pacemaker clinical trials 7–10 . Recently, a provocative clinical observation derived from the Micra transcatheter pacemaker IDE trial showed the absence of device infection in the setting of documented bacteremia or endocarditis 11 .…”

Section: Introductionmentioning

confidence: 99%

Reduced bacterial adhesion with parylene coating: Potential implications for Micra transcatheter pacemakers

El‐Chami

Mayotte

Bonner

et al. 2020

Cardiovasc electrophysiol

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Introduction Infections of cardiac implantable electronic devices remain a prevalent health concern necessitating the advent of novel preventative strategies. Based on the observation that bacterial infections of the Micra transcatheter pacemaker device are extremely rare, we examine the effect of parylene coating on bacterial adhesion and growth. Methods Bacterial growth was compared on polyurethane coated, bare, or parylene coated titanium surfaces. Eight test samples per bacterial species and material combination were incubated with Staphylococcus Aureus or Pseudomonas aeruginosa for 24 hours and then assayed for bacterial growth. The surface contact angle was also characterized by measuring the angle between the tangent to the surface of a liquid droplet made with the surface of the solid sample. Results The mean bacterial colony counts were significantly reduced for both parylene coated titanium versus bare samples (3.69 ± 0.27 and 4.80 ± 0.48 log[CFU/mL] respectively for S. aureus [P < .001] and 5.51 ± 0.27 and 6.08 ± 0.11 log[CFU/mL] respectively for P. aeruginosa [P < .001]), and for parylene coated titanium versus polyurethane samples (4.27 ± 0.42 and 5.40 ± 0.49 log[CFU/mL] respectively for S. aureus [P < .001] and 4.23 ± 0.42 and 4.84 ± 0.32 log[CFU/mL] respectively for P. aeruginosa [P = .006]). Parylene coated titanium samples had a higher contact angle compared with bare titanium, but lower compared with polyurethane (mean contact angle 87.5 ± 3.1 degrees parylene, 73.3 ± 3.7 degrees titanium [P < .001 vs parylene], and 94.8 ± 3.7 degrees polyurethane [P = .002 vs parylene]). Conclusions Parylene coating significantly reduced the ability of bacteria to grow in colony count assays suggesting that this could contribute to the reduction of bacterial infections of Micra transcatheter pacemakers.

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“…The early experience with a leadless pacemaker reported a 99% implant success rate, with 96% of patients free from major complication [72]. In a comparison between historical controls and leadless pacing implants, the relative risk of major complications was reduced by 48% with the leadless technology [73]. The data of the ‘real world’ MICRA leadless pacemaker have recently confirmed the short-term reliability of this type of device implant [74,75].…”

Section: The Future Of Electrical Therapies In Laminopathiesmentioning

confidence: 99%

Cardiolaminopathies from bench to bedside: challenges in clinical decision-making with focus on arrhythmia-related outcomes

Boriani

Biagini

Ziacchi

et al. 2018

Nucleus

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Lamin A/C gene mutations can be associated with cardiac diseases, usually referred to as ‘cardiolaminopathies’ characterized by arrhythmic disorders and/or left ventricular or biventricular dysfunction up to an overt picture of heart failure. The phenotypic cardiac manifestations of laminopathies are frequently mixed in complex clinical patterns and specifically may include bradyarrhythmias (sinus node disease or atrioventricular blocks), atrial arrhythmias (atrial fibrillation, atrial flutter, atrial standstill), ventricular tachyarrhythmias and heart failure of variable degrees of severity. Family history, physical examination, laboratory findings (specifically serum creatine phosphokinase values) and ECG findings are often important ‘red flags’ in diagnosing a ‘cardiolaminopathy’. Sudden arrhythmic death, thromboembolic events or stroke and severe heart failure requiring heart transplantation are the most dramatic complications of the evolution of cardiolaminopathies and appropriate risk stratification is clinically needed combined with clinical follow-up. Treatment with cardiac electrical implantable devices is indicated in case of bradyarrhythmias (implant of a device with pacemaker functions), risk of life-threatening ventricular tachyarrhythmias (implant of an ICD) or in case of heart failure with wide QRS interval (implant of a device for cardiac resynchronization). New technologies introduced in the last 5 years can help physicians to reduce device-related complications, thanks to the extension of device longevity and availability of leadless pacemakers or defibrillators, to be implanted in appropriately selected patients. An improved knowledge of the complex pathophysiological pathways involved in cardiolaminopathies and in the determinants of their progression to more severe forms will help to improve clinical management and to better target pharmacological and non-pharmacological treatments.

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Long-term performance of a transcatheter pacing system: 12-Month results from the Micra Transcatheter Pacing Study

Abstract: Long-term performance of the Micra transcatheter pacemaker remains consistent with previously reported data. Few patients experienced major complications through 12 months of follow-up, and all patient subgroups benefited as compared to transvenous pacemaker historical control group.

Cited by 257 publications

References 16 publications

Leadless pacemaker implant in patients with pre‐existing infections: Results from the Micra postapproval registry

Leadless pacemaker implant in patients with pre‐existing infections: Results from the Micra postapproval registry

Reduced bacterial adhesion with parylene coating: Potential implications for Micra transcatheter pacemakers

Cardiolaminopathies from bench to bedside: challenges in clinical decision-making with focus on arrhythmia-related outcomes

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