Project description:BackgroundCongenital absence of superior vena cava (CASVC) is an extremely rare vascular anomaly often associated with conduction disturbances which makes implantation of a pacemaker difficult. We report a case of pacemaker implantation in a patient presenting with complete atrioventricular block (c-AVB) with bilateral absence of the SVC.Case summaryA 68-year-old man who had experienced dyspnoea on exertion by c-AVB was admitted to our hospital for treatment and management. Permanent pacemaker insertion was initially planned; however, an endocardial pacemaker lead could not be implanted in the right atrium. Computed tomography scan with contrast revealed that the venous blood from the upper half of the body flowed into the inferior vena cava via the azygos vein. Due to the difficulty of inserting an endocardial lead from the subclavian vein, a leadless pacemaker (LP) was implanted instead via the femoral vein.DiscussionThis is the first case of an LP implantation in a patient presenting with c-AVB with CASVC. Confirmation of blood vessel anatomy to rule out CASVC is necessary prior to pacemaker implantation when abnormal venous anatomy is suspected.
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.
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.
Project description:Leadless pacemakers have many advantages for some patients in preventing lead- and pocket-related complications. The traveling of the femoral vein is important in the context of normal approach site choice for leadless pacemakers. In this case, the leadless pacemaker could be successfully implanted without disrupting the inferior vena cava filter by using intravascular ultrasound in a hemodialysis patient with complete atrioventricular block and atrial fibrillation who had obstruction of the bilateral subclavian and right femoral veins, and travel abnormality of the left common iliac vein. <Learning objective: The leadless pacemaker is a useful option in patients with complex vascular complications and hemodialysis. However, there are several listed contraindications such as the presence of inferior vena cava (IVC) filter that was excluded in the large-scale trials to leadless pacemakers. Intravascular ultrasound is a useful tool to place the leadless pacemaker without disrupting IVC filter to maintain its filtering capability.>.
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.
Project description:Background:A leadless pacemaker is a new concept in which a miniaturized pacing device is self-contained within the heart. Recently published data show that leadless pacemakers are associated with a decreased risk of major complications when compared with transvenous cardiac pacemakers. This seems to be of particular importance in children and young adults in whom various complications may occur during their lifetime. Case summary:Herein, we report the successful implantation of Micra™ Transcatheter Pacing System in two children: 12-year-old boy and 13-year-old girl, along with a long-term follow-up. The children had indications for pacemaker implantation, however, with an expected low percentage of pacing due to paroxysmal nature of the third-degree atrioventricular block. The implantation procedures were performed in general anaesthesia. There were no complications. During the 2-year follow-up, there were no adverse events and the electrical parameters of the device remained stable. Pacing percentage was below 0.1%. Discussion:Transvenous cardiac pacemakers improve quality of life and reduce mortality but may be associated with various short- and long-term complications, mainly related to the presence of transvenous leads and the pulse generator. Compared with adult patients, the implantation of conventional pacemakers in children is still a challenge, not only because of their smaller size but also due to continuing growth, as well as a higher rate of lead and device-related complications. We demonstrate that the implantation of leadless pacemakers in children is feasible and could be worth considering in certain clinical scenarios, especially when ventricular pacing is required rarely.
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.
Project description:AimsThere is limited information on what clinical factors are associated with the development of pericardial effusion after leadless pacemaker implantation. We sought to determine predictors of and to develop a risk score for pericardial effusion in patients undergoing Micra leadless pacemaker implantation attempt.Methods and resultsPatients (n = 2817) undergoing implant attempt from the Micra global trials were analysed. Characteristics were compared between patients with and without pericardial effusion (including cardiac perforation and tamponade). A risk score for pericardial effusion was developed from 18 pre-procedural clinical variables using lasso logistic regression. Internal validation and future prediction performance were estimated using bootstrap resampling. The scoring system was also externally validated using data from the Micra Acute Performance European and Middle East (MAP EMEA) registry. There were 32 patients with a pericardial effusion [1.1%, 95% confidence interval (CI): 0.8-1.6%]. Following lasso logistic regression, 11 of 18 variables remained in the model from which point values were assigned. The C-index was 0.79 (95% CI: 0.71-0.88). Patient risk score profile ranged from -4 (lowest risk) to 5 (highest risk) with 71.8% patients considered low risk (risk score ≤0), 16.6% considered medium risk (risk score = 1), and 11.7% considered high risk (risk score ≥2) for effusion. The median C-index following bootstrap validation was 0.73 (interquartile range: 0.70-0.75). The C-index based on 9 pericardial effusions from the 928 patients in the MAP EMEA registry was 0.68 (95% CI: 0.52-0.83). The pericardial effusion rate increased significantly with additional Micra deployments in medium-risk (P = 0.034) and high-risk (P < 0.001) patients.ConclusionThe overall rate of pericardial effusion following Micra implantation attempt is 1.1% and has decreased over time. The risk of pericardial effusion after Micra implant attempt can be predicted using pre-procedural clinical characteristics with reasonable discrimination.Clinical trial registrationThe Micra Post-Approval Registry (ClinicalTrials.gov identifier: NCT02536118), Micra Continued Access Study (ClinicalTrials.gov identifier: NCT02488681), and Micra Transcatheter Pacing Study (ClinicalTrials.gov identifier: NCT02004873).