Extraction of a 4-year-old leadless pacemaker with a tine-based fixation.
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ABSTRACT:
SUBMITTER: Kiani S
PROVIDER: S-EPMC6700998 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundLeadless pacemaker implantation rates are increasing worldwide. Until now leadless pacemaker dislocation and extraction has been rarely reported.Case summaryAn 83-year-old patient with cardiac amyloidosis, chronic atrial fibrillation, and complete heart block was implanted with a leadless pacemaker (Micra, Medtronic). On the day after implantation, the device showed an exit block and on cardiac echocardiography and cardiac computer tomography, a device dislocation could be detected. During the day, the device moved at least three times between the tricuspid valve and the right ventricular apex. Each time causing non-sustained ventricular tachycardia. At the next day device extraction was scheduled. After 189?minutes of procedure time, it was possible to retrieve the device with the help of two steerable introducers (Agilis) and two snare catheters.DiscussionImplantable transcatheter leadless pacemakers can be implanted safely most of the time. However, in rare cases device dislocations may occur. Device extraction is possible, but is described as challenging in most published cases 10.1093/ehjcr/ytz113_audio1 ytz113_audio1 6074457264001.
| S-EPMC6764563 | biostudies-literature
Project description: Not available
| S-EPMC8441210 | biostudies-literature
Project description:BackgroundA new intracardiac leadless pacemaker (ILP) has been developed to ensure atrioventricular (AV) synchrony (AVS) during ventricular pacing (VP). Recent studies have shown the feasibility and safety of accelerometer-based atrial sensing and an improvement in AVS among patients with atrioventricular block implanted with the Micra AV ILP (Medtronic Inc., Minneapolis, MN, USA). However, no data exists about the benefits of a VDD ILP in patients wearing a still working VVI Nanostim ILP (St Jude Medical, St Paul, MN, USA). We describe the feasibility of the procedure and the absence of device-related adverse events in the short-term follow-up.Case summaryWe present the case of a 72-year-old man implanted with a VVI ILP (Nanostim, St Jude Medical, St Paul, MN, USA) on May 2014, who has developed symptomatic high percentage of VVI asynchronous pacing and was treated with an upgrade to synchronous AV pacemaker (PM) ILP-Micra AV (Medtronic Inc., Minneapolis, MN, USA), which has improved symptoms and functional class.DiscussionIntracardiac leadless pacemakers represent the best current option for patients requiring PM implantation who are at high risk of infection and bleeding. Our case shows that the new AVS ILP is a good alternative to VVI ILP in patients with sinus rhythm and a strong need for VP.
| S-EPMC8364773 | biostudies-literature
Project description:A subclinical cardiac perforation by a device cup of the Micra™ transcatheter pacing system was suspected in a 78-year-old woman. During the procedure, the device cup was placed on the septum. The contrast media was injected before device deployment and remained outside of the myocardium. Later, a cardiac computed tomography scan visualized a protruded diverticular structure on the right ventricle. The contrast material remained in a pouch within the pericardium. To ensure the device is oriented away from the border between the right ventricular septum and the free wall, right anterior oblique view should be carefully reviewed before deployment.
| S-EPMC6009778 | biostudies-literature
Project description:We report a rare phenomenon during implantation of a leadless pacemaker. The device was dislodged into the left pulmonary artery (PA) during the implantation procedure and then migrated the next day from the left PA to the right PA. (Level of Difficulty: Advanced.).
| S-EPMC9334138 | biostudies-literature
Project description:BackgroundCardiac perforation during leadless pacemaker implantation is more likely to require intervention than perforation by a transvenous lead. This study reports the consequences of Micra pacemaker perforations and related device and operator use problems based on information the manufacturer has submitted to the Food and Drug Administration (FDA).MethodsFDA's Manufacturer and User Facility Device Experience (MAUDE) database was searched for Micra perforations. Data extracted included deaths, major adverse clinical events (MACEs), and device and/or operator use problems.ResultsBetween 2016 and July 2021, 563 perforations were reported within 30 days of implant and resulted in 150 deaths (27%), 499 cardiac tamponades (89%), 64 pericardial effusions (11%), and 146 patients (26%) required emergency surgery. Half of perforations were associated with 139 (25%) device problems, 78 (14%) operator use problems, and 62 (11%) combined device and operator use problems. Inadequate electrical measurements or difficult positioning were the most frequent device problems (n = 129); non-septal implants and perforation of other structures were the most frequent operator use problems (n = 69); a combined operator use and device problem resulted in 62 delivery system perforations. No device or operator use problem was identified for 282 perforations (50%), but they were associated with 78 deaths, 245 tamponades, and 57 emergency surgeries.ConclusionThe Micra perforations reported in MAUDE are often associated with death and major complications requiring emergency intervention. Device and use problems account for at least half of perforations. Studies are needed to identify who is at risk for a perforation and how MACE can be avoided or mitigated.
| S-EPMC9305184 | biostudies-literature
Project description:BackgroundThe use of transvenous pacing leads is associated with the risk of developing tricuspid valve (TV) dysfunction. This develops through several mechanisms including the failure of leaflet coaptation or direct damage to the TV or to its sub-valvular apparatus and can result in significant tricuspid regurgitation (TR). Multiple approaches to pacemaker implantation after transvenous lead extraction (TLE) or surgical TV repair have been described. Placement of pacing leads across the TV is generally avoided in such circumstances.Case summaryA 66-year-old woman presented with a year-long history of exertional dyspnoea, peripheral oedema, and postural neck pulsations. Her medical history included a dual-chamber pacemaker implantation for sinus node dysfunction 14 years ago. Echocardiography revealed severe lead-related TR. Her case was discussed in our multi-disciplinary team meeting. A decision was made to perform a TLE and implant a leadless pacemaker in an attempt to avoid open-heart surgery if possible. This was reserved as an option in the event of persistent severe TR. Transvenous extraction of the right ventricular lead was performed. The atrial lead was preserved and connected to and AAI device. A Micra AV was implanted allowing for atrioventricular (AV) synchronous pacing.DiscussionWe present the first case of successful implementation of AV sequential pacing using a dual-pacemaker approach involving the use of an AAI pacemaker and a Micra AV device. This was performed after TLE for severe lead-related TR.
| S-EPMC8343438 | biostudies-literature
Project description:PURPOSE:Use of novel medical technologies, such as leadless pacemaker (LP) therapy, may be subjected to a learning curve effect. The objective of the current study was to assess the impact of operators' experience on the occurrence of serious adverse device effects (SADE) and procedural efficiency. METHODS:Patients implanted with a Nanostim LP (Abbott, USA) within two prospective studies (i.e., LEADLESS ll IDE and Leadless Observational Study) were assessed. Patients were categorized into quartiles based on operator experience. Learning curve analysis included the comparison of SADE rates at 30 days post-implant per quartile and between patients in quartile 4 (>?10 implants) and patients in quartiles 1 through 3 (1-10 implants). Procedural efficiency was assessed based on procedure duration and repositioning attempts. RESULTS:Nanostim LP implant was performed in 1439 patients by 171 implanters at 60 centers in 10 countries. A total of 91 (6.4%) patients experienced a SADE in the first 30 days. SADE rates dropped from 7.4 to 4.5% (p =?0.038) after more than 10 implants per operator. Total procedure duration decreased from 30.9?± 19.1 min in quartile 1 to 21.6?± 13.2 min (p <?0.001) in quartile 4. The need for multiple repositionings during the LP procedure reduced in quartile 4 (14.8%), compared to quartiles 1 (26.8%; p <?0.001), 2 (26.6%; p <?0.001), and 3 (20.4%; p =?0.03). CONCLUSIONS:Learning curves exist for Nanostim LP implantation. Procedure efficiency improved with increased operator experience, according to a decrease in the incidence of SADE, procedure duration, and repositioning attempts.
| S-EPMC6182715 | biostudies-literature
Project description:IntroductionThe number of pacemaker and ICD implantations has increased substantially in the recent years. Therefore, complications are also observed in a greater number. In many cases, transvenous extraction of the previously implanted device (pacemaker or ICD) is the only solution. One may find in the literature information about the efficacy and safety of that procedure, but data concerning the results of long-term follow up are still limited.AimThe aim of the study was to assess the one-year mortality in the cohort of patients undergoing transvenous lead extraction procedures in our centre.MethodsRecords of the patients undergoing transvenous lead removal in the Department of Cardiology and Electrotherapy of the Medical University of Gda?sk were analyzed. We collected detailed information about 192 patients that had undergone the procedure from January 2003 until June 2012. Data were collected from medical and surgical records. We analyzed concomitant diseases, indications, and possible complications. Long-term follow-up data were gathered in the follow-up ambulatory records and over-the-phone interviews with patients or families. In several cases, we consulted the database of the Polish National Health Fund.ResultsDuring the early post-operative period 5 patients died, although none of those deaths was associated with the procedure itself. No other major complications were observed. During one-year follow-up other 5 patients died, which gave the overall one-year survival rate of 92.7%. Heart failure, renal failure and an infective indication showed significant association with increased mortality.ConclusionResults of transvenous lead extraction, a relatively safe procedure, should be assessed over time extending beyond the sole perioperative period. Some complications may be delayed in their nature, and may be observed only during the long-term follow up.
| S-EPMC4691200 | biostudies-literature
Project description: Not available
| S-EPMC6926231 | biostudies-literature