Leadless Pacemaker Implantation Research Articles

Bacteraemia after leadless pacemaker implantation.

Transvenous 3permanent pacemaker-related infection is a severe condition associated with significant morbidity and mortality. Leadless pacemakers may be more resistant to bacterial seeding during bloodstream infection because of its small surface area and encapsulation in the right ventricle. This study reports the incidence and outcomes of bacteraemia in patients implanted with a Micra leadless pacemaker. We present 18 F-fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) findings obtained in a subgroup of patients. We report a retrospective cohort study of 155 patients who underwent a Micra TPS implant procedure at the University Hospitals of Leuven between July 2015 and July 2019. We identified the patients who developed an episode of bacteraemia, proved by≥2 positive blood cultures. Of the 155 patients, 15 patients presented an episode of bacteraemia at a median of 226 days (range: 3-1129) days after the implant procedure. Gram-positive species accounted for 73.3% (n = 11) of the bacteraemia including Staphylococcus (n = 5), Enterococcus (n = 3), and Streptococcus (n = 3). The source of infection was identified in nine patients (60%) including endocarditis in four patients, urinary tract in three patients, and skin in two patients. 18 F-FDG PET/CT imaging performed in six patients did not show sign of infection around the leadless pacemaker. Bacteraemia was resolved in all patients after adequate antibiotherapy. Four patients died early during follow up. For all other patients, there were no recurrence of systemic infection during a median follow up of 263 days (range: 15-1134). In our small cohort, no leadless pacemaker endocarditis was observed among patients with bacteraemia.

Leadless pacemaker implantation in postpneumonectomy syndrome

About 4.5–20% of patients after heart transplant require pacemaker (PM) implantation. The high infective risk profile and the low probability of pacing dependency make heart-transplanted patients the ideal candidates for a leadless single-chamber PM. We report the first multicenter experience of leadless PM implantation in a series of heart-transplanted patients with a long-term follow-up. Our data confirm the feasibility and acceptable safety of leadless device in this peculiar kind of patients, despite implantation seems to be slightly more challenging with respect to non-transplanted patients. Although more data are required, a leadless single-chamber surveillance PM seems a valuable option for heart-transplanted patients.

P425Single procedure pace and ablate. evaluation of efficacy and safety comparing three different vascular routes

Abstract Funding Acknowledgements No financial support for this study Introduction Permanent pacemaker implantation combined with AVN ablation is a well-established treatment for rate control in patients with atrial fibrillation refractory to medical therapy. At the same sitting, this has been achieved in a single procedure via the subclavian vein (SCV) for both pacemaker implantation and AVN ablation, by pacemaker implantation via the SCV with femoral access for AVN ablation or by using the femoral vein (FV) for leadless pacemaker implantation and AVN ablation with a coaxial single-puncture technique. We evaluated all combined procedures (pacemaker implantation and AVN ablation at the same sitting) performed in a single centre over 9 years comparing clinical outcomes, complications rates and procedure times. Statistical methods: Continuous variables are described as mean ± standard deviation (SD), and statistical differences between groups were evaluated by one-way ANOVA. A X2 test was used for categorical variables, with Fisher’s exact test for any field where the expected frequency was ≤5 with pvalue < 0.05 considered as statistically significant. The statistical analysis was performed using SPSS software package. Results 141 patients underwent AVN ablation at our institution as part of a ‘pace and ablate’ single procedure strategy between 14/2/11 and 10/6/19. 61 patients had a combined procedure via the SCV, 66 patients had pacemaker implanted via the SCV and AVN ablation via the FV in the same sitting and 14 patients had leadless pacemaker (Micra) implantation and AVN ablation via the FV. Our findings suggest that the fluoroscopy time as well as the total catheter laboratory time were much less in the Micra group compared to the other groups. In the conventional pacemaker groups (group 1 and 2), the fluoroscopy time was not statistically different between the two. There was a trend towards acute procedural failure, switching to another access as well as a higher complication rate in the SCV group, however this has not reached statistical significance. Conclusion Our early data suggests that pacemaker implantation and AVN ablation with a coaxial single femoral vein puncture technique is safe and takes less fluoroscopy time as well as total laboratory time. Procedural outcomes All (n = 141) Group 1: SCV (n = 61) Group 2: FV (n = 66) Group 3: Micra (n = 14) P-value Total cath-lab time (mins) 113.1 ± 40.4 106.2 ± 37.2 125.7 ± 42.5 86.9 ± 23.1 0.001 Total fluoroscopy time (mins) 8.8 ± 7.6 11 ± 7.8 7.7 ± 7.6 4.5 ± 3 0.0001 Acute procedural failure, n (%) 9 (6.4) 7 (11.5) 2 (3) 0 (0) **0.6 Complications, n (%) 7 (4.9) 5 (8.2) 2 (3) 0 (0) **0.62 **Fisher"s exact test applied to analysis of Micra VS Other methods

P1149Subcutaneous implantable cardioverter-defibrillator when Transvenous ICD is not a viable option

Abstract Funding Acknowledgements NO FUNDING OnBehalf RHYTHM DETECT Registry Background The class of recommendation for S-ICD implantation in patients who have inadequate vascular access is I according to AHA-ACC-HRS Guidelines and IIb according to ESC Guidelines. Data are lacking about the use of S-ICD for patients in which a transvenous ICD is not a viable option because of the inability to deploy a transvenous lead. Purpose To describe current practice and to measure outcomes associated with S-ICD use in patients in which a transvenous ICD is not a viable option. Methods 942 consecutive patients underwent S-ICD implantation at 22 Italian centers from 2014 to 2019. We identified 101 (11%) patients who received S-ICD because of the reported impossibility of deploying a transvenous lead. Results 21 patients presented with inadequate vascular access but no previous device in place. One patient had a mechanical prosthesis in tricuspid position. The remaining 79 patients received the S-ICD after removal of a prior system implanted, and venous occlusion was diagnosed after lead extraction, or partially or completely failed lead removal. In 24 of these patients a functional transvenous pacing system was left in place for persisting pacing needs. Patients were 60 ± 15 years old, 85% were male, 77% had ischemic or non-ischemic dilated cardiomyopathy, ejection fraction was 36 ± 13%. At implantation, acute conversion test was performed in 64 patients and shock energy of ≤65J was successful in 62 (96.9%) patients. During a median follow-up of 18 months, 6 patients died for non-device related reasons and 1 patient underwent heart transplantation. One patient underwent device replacement for battery depletion and one patient underwent leadless pacemaker implantation. Minor complications (hematomas not requiring system revision) were reported in 2 patients. Appropriate therapies were delivered in 4 patients and 8 patients experienced inappropriate therapies (in 3 patients due to double counting during pacing); all resolved with device reprogramming. Conclusions: In current clinical practice, a minority of S-ICD patients receive the device because of inadequate vascular access. The profile of these patients is similar to that of the typical ICD population in the context of primary sudden death prevention, but many of them present with pacing indications. Acute and mid-term efficacy of S-ICD seemed high. Few complications occurred during follow-up. Particular attention must be paid to device programming for those patients with concomitant pacing systems, in order to prevent inappropriate therapies.

P1470Outcome of leadless pacemaker implantation in a referral centre for lead extraction: a comparison with transvenous pacemaker

Abstract Background Leadless cardiac pacing is a promising technology in terms of efficacy and safety. Purpose The aim of the study was to compare the long-term clinical and electrical performance of Micra leadless pacemaker with ventricular single-chamber transvenous pacemaker (VVI TV-PM) in a high-volume centre for transvenous lead extraction (TLE). Methods Between May 2014 and April 2019, 100 patients (group 1) underwent Micra implant at our centre. We identified 100 patients (group 2) who underwent VVI TV-PM implant in the same period for a 1:1 comparison matched by age, sex, left ventricular systolic ejection fraction and previous TLE. Results The implant procedure was successful in all patients. In group 1, the procedure duration was lower than in group 2 (43.86 ± 22.38 vs 58.38 ± 17.85 min, p < 0.001), while the fluoroscopy time was longer (12.25 ± 6.84 vs 5.32 ± 4.42 min, p < 0.001). There was no difference about the rate of septal deployment at the right ventricle (group 1 vs group 2: 76% vs 86%, p = 0.10). Patients were followed-up for a median of 12 months. We did not observe any acute and chronic procedure-related complications in group 1, while we reported acute complications in seven patients (0 vs 7%, p = 0.02) and long-term complications in three patients (0 vs 3%, p = 0.24), needing for a system revisions in 6 cases (0 vs 6%, p = 0.038) in group 2. One systemic infection occurred during follow-up in a patient with VVI TV-PM. Electrical measurements were stable during follow-up in both groups, with a longer estimated battery life in group 1 (mean delivered energy at implant group 1 vs group 2: 0.14 ± 0.21 vs 0.26 ± 0.22 μJ, p < 0.001). Conclusion Micra pacemaker implant is a safe and effective procedure, with a lower rate of acute complications and system revisions and a longer estimated battery life compared to VVI TV-PM, even in a real life setting including patients who underwent TLE.

Safety of leadless pacemaker implantation in the very elderly

The Micra leadless pacemaker (MLP) has proven to be an effective alternative to a traditional transvenous pacemaker (TVP). However, there has been concern about using the MLP in frail elderly patients because of the size of the implant sheath and perceived risk of perforation. The objectives of this study were to report the safety of the MLP and compare MPLs with TVPs in the very elderly. All patients 85 years and older who received an MLP or a single-chamber TVP across 6 hospitals in the Northwell Health system from December 2015 to November 2019 were included. Demographic characteristics, procedural details, and procedure-related complications were reviewed. Over 4 years, 564 patients underwent MLP implantation. During this time, 183 MLPs and 119 TVPs were implanted in patients 85 years and older. The mean age was 89.7 ± 3.4 years, and 47.4% were men. MLP implantation was successful in all but 3 patients (98.4% success rate). There was no difference in procedure-related complications (3.3% vs 5.9%; P = .276). Complications included 5 (2.7%) access site hematomas in the MLP group, 3 (2.5%) in the TVP group, 1 (0.5 vs 0.8%) pericardial effusion in each group, and 3 (2.5%) acute lead dislodgments (<24 hours) in the TVP group. MLP implantation resulted in a significantly shorter mean procedure time (35.7 ± 23.0 minutes vs 62.3 ± 31.5 minutes, P < .001). In a large multicenter study of patients 85 years and older, MLP implantation (1) was successful in 98.4% of patients, (2) was safe with no difference in procedure-related complications compared to the TVP group, and (3) resulted in significantly shorter procedure times.

Determinants of the difficulty of leadless pacemaker implantation.

The Micra Transcatheter Pacing System is implanted directly in the right ventricle (RV) through the femoral vein using a steerable transcatheter delivery system. The present study was done to identify determinants of difficult leadless pacemaker implant procedures including operator, patient, and RV anatomical characteristics. All patients who underwent a Micra implant from July 2015 to December 2018 at our center were analyzed. From an RV angiogram acquired during implantation, RV geometry including systolic and diastolic volumes and ejection fraction was characterized. The presence of septomarginal trabeculation was noted. One hundred twenty-six patients (mean age: 79±11years old, mostly male: 77%) were enrolled. Mean Micra RV implant procedure time was 24±23min, with 1.7±1.3 deployments of the device. No significant change in implant procedure time was observed after the first 30 implants. Eleven patients had a prominent septal component of the septomarginal trabeculation in the RV. Univariate analysis showed that the procedure time was positively correlated with the presence of a prominent septal component of the septomarginal trabeculation (P<.001) or an episode of heart failure (P=.02) and negatively correlated with the number of procedures performed by the operator (P<.001). After multivariable analysis, only the presence of a prominent septal component of the septomarginal trabeculation (P<.001) and the number of procedures performed by the operator (P<.001) were associated with the implant procedure time. In our experience, implant procedure time of a Micra leadless pacemaker depended on the presence of a prominent septal component of the septomarginal trabeculation and operator experience.

First transcatheter leadless pacemaker implantation in apediatric patient with agenetic disease.

Apediatric patient suffering from Marden-Walker syndrome, arare genetic disease, was referred to the authors' hospital for syncope due to bradycardia. Since this disease is associated with severe joint contractures, atranscatheter leadless pacing system (TPS) was chosen. Despite the small body size and complex anatomy, TPS implantation was feasible, demonstrating that it is asafe alternative in difficult venous access compared to aconventional pacemaker with increased risk of lead complications in these patients.

Leadless pacemaker implantation quality: importance of the operator’s experience

Leadless cardiac pacemaker (PM) implantation differs from conventional PM implantation. While the procedure has been considered safe, recent real-world data raised concerns about the learning curve of new operators and their implantation quality. The goal of this study was to investigate the influence of the first operator's experience on leadless PM implantation quality and procedural efficiency. We performed a bicentric analysis of all Micra TPS™ implantations in two large tertiary referral hospitals. We assessed both leadless PM implantation quality based on the absence of complications (requiring intervention or prolonged hospitalization), good electrical performance (pacing threshold ≤ 1.5 V/0.24 ms, R-wave amplitude > 5 mV), and acceptable fluoroscopy duration (<10 min) as well as procedural efficiency in relation to the operator's experience. Univariate and multivariate logistic regression analyses were performed to identify predictors for implantation quality and procedural efficiency. Leadless PM implantation was successful in 106/111 cases (95.5%). Three patients (2.7%) experienced acute complications (one cardiac tamponade, one femoral bleeding, one posture-related PM exit block). Multivariate analysis showed that implantation quality of more experienced first operators was higher [odds ratio 1.09 (95% confidence interval 1.00-1.19), P = 0.05]. Procedural efficiency increased with operator experience as evidenced by an inverse correlation of procedure time, time to the first deployment, fluoroscopy time, and the number of procedures performed (all P < 0.05). The operator's learning curve is a critical factor for leadless PM implantation quality and procedural efficiency.

Implantation of leadless pacemaker through neo-orifice after tricuspid valve edge-to-edge repair.

Implantation of leadless pacemaker through neo-orifice after tricuspid valve edge-to-edge repair.

Peak deflection index as a predictor of a free-wall implantation of contemporary leadless pacemakers.

Leadless pacemakers are an effective treatment for bradycardia. However, some cases exhibit pericardial effusions, presumably associated with device implantations on the right ventricular free-wall. The present study was carried out to find the ECG features during ventricular pacing with a Micra, which enabled distinguishing free-wall implantations from septal implantations without using imaging modalities. Thirty-one consecutive patients who received Micra implantations in our facility were enrolled. The location of the device in the right ventricle was evaluated using echocardiography or computed tomography in order to determine whether the device was implanted on the septum (Sep group), apex (Apex group), or free-wall (FW group). The differences in the 12-lead ECG during ventricular pacing by the Micra were analyzed between the Sep and FW groups. The body of the Micra was clearly identifiable in 22 patients. The location of the device was classified into Sep in 12 patients, Apex in 4, and FW in 6. The mean age was highest in the FW and lowest in the Sep group (82.7 ± 6.6 vs. 72.8 ± 8.7years, p = 0.027). The peak deflection index (PDI) was significantly larger in the FW group than Sep/Apex group in lead V1 (Sep: 0.505 ± 0.010, Apex: 0.402 ± 0.052, FW: 0.617 ± 0.043, p = 0.004) and lead V2 (Sep: 0.450 ± 0.066, Apex: 0.409 ± 0.037, FW: 0.521 ± 0.030, p = 0.011), whereas there was no difference in the QRS duration, transitional zone, and QRS notching. The PDI in V1 could be useful for predicting implantations of Micra devices on the free-wall and may potentially stratify the risk of postprocedural pericardial effusions.

Leadless pacing in cardiac transplant recipients: Primary results of a multicenter case experience

About 4.5–20% of patients after heart transplant require pacemaker (PM) implantation. The high infective risk profile and the low probability of pacing dependency make heart-transplanted patients the ideal candidates for a leadless single-chamber PM. We report the first multicenter experience of leadless PM implantation in a series of heart-transplanted patients with a long-term follow-up. Our data confirm the feasibility and acceptable safety of leadless device in this peculiar kind of patients, despite implantation seems to be slightly more challenging with respect to non-transplanted patients. Although more data are required, a leadless single-chamber surveillance PM seems a valuable option for heart-transplanted patients.

The feasibility of leadless pacemaker implantation for superelderly patients

The safety and efficacy of the leadless pacemaker (LP) have been confirmed in previous reports, yet studies on LPs in superelderly patients are limited. A total of 62 patients aged over 85 years old were implanted with single-chamber pacemakers due to symptomatic bradyarrhythmia at Sakakibara Heart Institute from May 2014 through July 2019. We divided them into two groups, a transvenous (TV) single-chamber pacemaker group (35 patients) and an LP group (27 patients), and compared the groups. Mean participant age was 90.3 ± 3.8 y.o., 41.9% were male, and mean participant body mass index (BMI) was 21.3kg/m2 . The LP group contained a significantly larger proportion of patients with dementia than the TV group did (63%vs. 37.1%, P=.04). The complication-free rate tended to be lower in the LP group in spite of the higher frequency of dementia (88.6%vs. 92.6%, P=.68). At implantation, the pacing threshold was significantly higher in the LP group than in the TV group (1.30 ± 0.91 V vs. 0.71 ± 0.23 V, P<.01), but over the first 3 months after the operation the pacing threshold in the LP group gradually improved (0.82 ± 0.2 V vs. 1.05 ± 1.02 V, P=.16). The procedure time and time from operation to discharge were also shorter in the LP group. LP implantation appears to be safe and is accordingly becoming the cornerstone for Japanese superelderly patients indicated for single-chamber pacemakers, even for those with small bodies and dementia. However, careful procedures and long follow-ups are needed until a greater volume of data is reported.

LEADLESS PACEMAKER IMPLANT IN A HEART TRANSPLANT PATIENT

Heart transplant recipients are at high risk for complications of conventional pacemakers. We present the second known case of a leadless pacemaker implantation in a heart transplant recipient in the US and third published case in the world. A 55 year-old male with non-ischemic cardiomyopathy

Leadless pacemaker implantation in a 102-year old patient – a case report

People over 65 years old account for almost one fifth (19%) of the European population. A percentage of the oldest old in this group also increases. Patients over 80 years old are burdened with a number of comorbidities with the lead of cardiovascular diseases (CVD). An aging organism creates demanding conditions for pacemaker implantation and surgery in general. We report a case of a 102-year old patient with tachycardia-bradycardia syndrome and syncope who has had MicraTM Transcatheter Pacing System (Micra TPS, Medtronic, Minneapolis, MN, USA) implantated.

Implantation of the Micra transcatheter pacing system: Single Polish center experience with the real costs of hospitalization analysis.

The Micra transcatheter pacing system (TPS) is a miniaturized, single-chamber pacemaker system. Study reported herein is an initial experience with implantation of the Micra TPS. The leadless pacemaker was implanted in 10 patients with standard indications for a permanent pacemaker implantation. All hospitalization costs were calculated for all patients. The mean age of the patients was 75 ± 7.1 years, 6 were men and 4 were women. Four patients had permanent atrial fibrillation as the basal rhythm and 6 patients had sinus rhythm. All patients had at least one relative contraindication that precluded the use of a traditional pacing system. Mean intraoperative ventricular sensing amplitude was 10.6 ± 5.4 mV, impedance 843 ± 185 ohms, and pacing threshold at 0.24 ms was 0.56 ± 0.23 V. At discharge, those values were 13.9 ± 5.6 mV, 667 ± 119 ohms and 0.47 ± 0.17, respectively. The mean duration of implantation procedure was 82 min, while mean fluoroscopy time was 3.5 min. Two patients developed hematoma at the groin puncture site post-implantation. In 1 case there was a need for erythrocyte mass transfusion and surgical intervention. Mean total time of hospitalization was 26 days and time from procedure to discharge 12 days. Average cost of hospitalization per 1 patient was 11,260.15 EUR minimal cost was 9,052.68 EUR, while maximal cost was 16,533.18 EUR. Implantation of leadless pacemakers is feasible, safe and provides advantages over the conventional system. Hospitalization costs vary for individual patients in wide range.

Concomitant leadless pacemaker implantation and lead extraction during an active infection.

The need for transvenous lead extractions due to cardiac implantable electronic device (CIED)-related infections continues to rise. Current guidelines recommend complete device removal in the setting of an active infection, which can be challenging in pacemaker-dependent patients. We retrospectively reviewed all leadless pacemaker implants between January 2018 and November 2019 and identified a subset of patients who had undergone a concomitant CIED extraction in the setting of an active infection. Baseline characteristics, procedural details, and clinical follow-ups were recorded. Seventeen patients received a leadless pacemaker during the same procedure as the CIED extraction. There were no procedural complications. All patients were being treated for an active CIED infection at the time of the procedure. Fourteen patients (82.4%) were completely pacemaker-dependent and four patients (23.5%) had positive blood cultures at the time of the leadless pacemaker implantation. During a median follow-up of 143 days (interquartile range: 57, 181 days), there were no recurrent infections. Simultaneous leadless pacemaker implantation and CIED extraction are safe and feasible in the setting of an active infection. This strategy may be particularly useful in patients that are pacemaker-dependent.

Peri-procedural management, implantation feasibility, and short-term outcomes in patients undergoing implantation of leadless pacemakers: European Snapshot Survey.

The aim of this European Heart Rhythm Association (EHRA) prospective snapshot survey is to assess procedural settings, safety measures, and short-term outcomes associated with implantation of leadless pacemakers (LLPM), across a broad range of tertiary European electrophysiology centres. An internet-based electronic questionnaire (30 questions) concerning implantation settings, peri-procedural routines, complications, and in-hospital patient outcomes was circulated to centres routinely implanting both LLPMs and transvenous pacemakers (TV-PM). The centres were requested to prospectively include consecutive patients implanted with either LLPMs or TV-PMs during the 10-week enrolment period. Overall, 21 centres from four countries enrolled 825 consecutive patients between November 2018 and January 2019, including 69 (9%) implanted with LLPMs. Leadless pacemakers were implanted mainly under local anaesthesia (69%), by an electrophysiologist (60%), in the electrophysiology laboratory (71%); 95% of patients received prophylactic antibiotics prior to implantation. Most patients on chronic oral anticoagulation were operated on-drug (35%), or during short-term (to 48 h) drug withdrawal (54%). Implantation was successful in 98% of patients and the only in-hospital procedure-related complication was groyne haematoma in one patient. This EHRA snapshot survey provides important insights into LLPM implantation routines and patient outcomes. These findings suggest that despite the unfavourable clinical profile of pacemaker recipients, LLPM implantation is associated with relatively low risk of complications and good short-term outcomes.

Using Medicare Claims to Identify Acute Clinical Events Following Implantation of Leadless Pacemakers.

BackgroundThere is heightened interest in how real-world data (RWD) can be used to supplement or replace traditional mechanisms for collecting clinical information. A critical component in evaluating utility of RWD is assessing the validity and reliability of event measurement. Only two studies have validated Medicare claims with physician-adjudicated data collected in a clinical study and none in the pacemaker patient population. This study compares events identified in physician-adjudicated clinical registry data collected in the Micra Post-Approval Registry (PAR) with events identified via Medicare administrative claims in the Micra Coverage with Evidence (CED) Study.MethodsPatients who were dually enrolled in the Micra CED and the Micra PAR between March 9, 2017 and December 1, 2017 were included in the validation analysis. All patients intended to be implanted with a Micra device were eligible for participation in the Micra PAR. All Medicare fee-for-service beneficiaries implanted with a Micra device who met the 12-month continuous enrollment criteria were included in the Micra CED. We compared the count of acute (30-day) complications identified in the Medicare claims and the physician-adjudicated PAR data to assess agreement between data sources.ResultsThere were 230 patients dually enrolled in the Micra CED and Micra PAR studies during the study period. Overall, there were 17 acute events reported in either the Micra CED or the Micra PAR, with 95% agreement in the identification of events and absence of events between studies. Study disagreement between events reported in either study varied: arteriovenous fistula (50%), pulmonary embolism (67%), hemorrhage/hematoma (75%), and deep vein thrombosis (100%). Among physician-adjudicated events, there was no disagreement between the Micra CED and Micra PAR studies in any event type.ConclusionFindings from this study demonstrate high agreement in event identification between Medicare claims data and registries for patients implanted with Micra leadless pacemakers.

Takotsubo syndrome suspcted being caused by leadless pacemaker implantation；Two case reports

Takotsubo syndrome suspcted being caused by leadless pacemaker implantation；Two case reports