Conventional Transvenous Pacemakers Research Articles

Comparison of Postoperative Outcomes between Leadless and Conventional Transvenous Pacemakers Implantation: An Up-to-Date Meta-analysis.

Leadless cardiac pacemakers (LCPs) are emerging as viable alternatives to conventional transvenous pacemakers (TVPs). This study aimed to systematically compare the postoperative outcomes of LCPs and TVPs based on available published studies. We conducted a systematic review and meta-analysis of literature comparing outcomes from LCP and TVP implantations. Data analysis was performed using Stata/MP 17.0. The evaluated endpoints included pericardial effusion or perforation, puncture site events, infective endocarditis, lead or device dislodgement, pocket-related complications, tricuspid regurgitation or dysfunction, any infection, increased right ventricle (RV) pacing threshold, embolism, and thrombosis. Aggregated odds ratios (OR) and 95% confidence intervals (CI) were determined. Sensitivity analyses were conducted for heterogeneity if I2 was >50% or p < 0.01, otherwise, the random-effects model was chosen. Publication bias was analyzed if the number studies exceeded ten. The meta-analysis included 24 observational studies with 78,938 patients, comprising 24,191 with LCP implantation and 54,747 with TVP implantation. The results indicated a significantly lower incidence of lead or device dislodgment (OR = 3.32, 95% CI: 1.91-5.77, p < 0.01), infective endocarditis (OR = 3.62, 95% CI: 3.10-4.24, p < 0.01), and infection (OR = 3.93, 95% CI: 1.67-9.24, p < 0.01) in the LCP group compared to the TVP group. In contrast, incidences of puncture site complications (OR = 0.24, 95% CI: 0.19-0.32, p < 0.01) and pericardial effusion or perforation (OR = 0.33, 95% CI: 0.28-0.39, p < 0.01) were significantly higher in the LCP group. Compared with TVP, LCP implantation is associated with a lower risk of infective endocarditis, lead or device dislodgment, infections, and pocket-related complications. However, LCP implantation carries a higher risk of puncture site complications and pericardial effusion or perforation. These findings underscore the need for careful consideration of patient-specific factors when choosing between LCP and TVP implantation. https://www.crd.york.ac.uk/prospero/ (CRD42023453145).

Implantable cardiac monitor and leadless pacemaker in the management of syncope due to intermittent high-degree atrioventricular block: a case report

BackgroundLead dislodgements, tricuspid valve failure, and wound infections are prominent issues addressed by leadless pacemakers (LPM). These devises have emerged as viable alternatives to conventional transvenous pacemakers. LPMs offer minimized complications and effective pacing, particularly beneficial for elderly patients with a low body mass index (BMI) who are at heightened infection of risk. The Micra AV leadless pacemaker was released in the US in 2020, featuring a VDD pacing mode akin to conventional pacemakers. It senses atrial activity to pace ventricular beats while maintaining the natural atrioventricular activation sequence. Micra AV achieves atrioventricular synchronization through mechanical sensing principles. Ongoing research aims to assess its efficacy, implantation feasibility, and clinical safety.Case presentationAn 83-year-old man with a history of syncope was the focus of this case study. An implantable cardiac monitor (ICM) recorded occasional high-degree atrioventricular block in the patient. Subsequently, the Micra AV was implanted via the left femoral vein, and its settings were adjusted in accordance with data obtained from the ICM. No significant issues regarding pacing threshold or impedance were found during the follow-up examinations post-surgery. Importantly, the patient experienced a noticeable reduction in symptoms compared to before the implantation.DiscussionThis case underscores the significance of ICM monitoring in elucidating cardiac events leading to syncope and guiding appropriate treatment. It also highlights the successful outcomes and reliable implantation of the Micra AV for managing high-degree atrioventricular block. This study contributes to the growing body of evidence supporting the adoption of leadless pacemakers as a viable option for patients requiring cardiac pacing, particularly those vulnerable to complications associated with traditional pacemakers. It provides real-world evidence of Micra AV’s efficacy and safety, further validating its role in clinical practice.

Outcomes of tine-based leadless pacemakers retrieval: a multicenter study

Abstract Background Leadless cardiac pacemakers (LCP) are well established in daily practice and comparable in safety as well as efficacy to conventional transvenous pacemakers. With increasing implant volumes, more patients may need extraction and retrieval of these devices. Data on extractability of LCPs is however scare. Purpose The aim of this study is to analyze indication, techniques, efficacy and safety of LCP extractions in a multicenter international registry. Methods This is an international, multicenter retrospective registry. Demographic parameters, indication of LCP extraction, success and complication rate were analyzed. Results A total of 50 patients (median age 71 years (IQR 64-81), 34% female) were included in this study. 52% of patients received the LCP for complete AV block. The primary underlying cardiac condition was coronary artery disease in 42%. The main indication for LCP extraction was rise in threshold with loss of capture (32%), upgrade to biventricular pacemaker (26%) or upgrade to transvenous dual-chamber device (14%) (Figure 1). The overall success rate of device extraction was 96% with a mean dwell time of the LCP of 715 days (range 0-1477 days). In most cases, a steerable sheath with a single loop snare (71%) was used (Figure 2). Procedure related adverse events were low and included two pericardial effusion (not requiring any intervention) and one case of a device embolization that was retrieved successfully in the same setting. Overall mortality at 7 days was 0 %. Conclusion Retrieval/extraction of chronically implanted LCP appear to be safe and feasible in centers with expertise in femoral snaring.Indication for LCP retrievalTools used for LCP extraction

MICRA AV implantation after transcatheter aortic valve replacement

BackgroundTranscatheter aortic valve replacement (TAVR) has evolved as a breakthrough therapy for patients with severe aortic valve stenosis. While TAVR has revolutionized the management of aortic valve disease, the procedure may be associated with the development of conduction disturbances requiring permanent pacemaker implantation. Traditionally, conventional transvenous pacemakers have been used to address these complications. However, the introduction of leadless pacemaker technology, such as the MICRA Transcatheter Pacing System (TPS), offers a novel alternative. Materials and methodsThis was a retrospective single-center study where all patients who underwent TAVR at our center and subsequently required permanent pacemaker implantation within 30 days were reviewed. We included only the patients who underwent leadless pacemaker placement. We then conducted a retrospective chart review to identify patient and procedural characteristics, procedural details, and relevant clinical outcomes. ResultsA total of 9 patients were identified. All of the patients underwent MICRA AV placement within 30 days post-TAVR by an interventional cardiologist. The average age of the cohort was 79.6 years with an average STS score of 3.7 %. The majority of the patients received balloon-expandable valves (78 %). There were no procedural complications in any of the patients. At an average follow-up of 353 days, capture thresholds and lead impedance remained stable with an average RV pacing of 13 %. ConclusionThis small, retrospective cohort demonstrates that the use of MICRA AV leadless pacemakers is feasible after TAVR and is associated with low periprocedural complications. Leadless pacemakers provide stable pacing thresholds and AV synchrony.

PP41 Using Medicare Claims Data To Support Reimbursement Of A Novel Leadless Pacing System For The Management Of Bradycardia

IntroductionThe Micra Transcatheter Pacing System (Micra TPS) is a single-chamber transcatheter leadless pacemaker (LPM). LPMs do not require leads or a subcutaneous pocket, which represent the primary sources of device-related complications with conventional transvenous pacemakers (TVPMs). Complications such as infections and lead dislodgements cause significant patient burden, which have significant economic consequences. Running a randomized controlled trial (RCT) to estimate risk differences of infrequent events requires large sample sizes and long follow-up periods. Real-world observational data, while informative, requires an appropriate study design and statistical adjustments to control for potential biases.MethodsThe Micra Coverage with Evidence Development (CED) study was a cohort study of LPM versus TVPM based on US Medicare claims data of 16,431 patients with 2-year follow up (LPM: n=6,219; TVPM: n=10,212). Propensity score matching (PSM) was applied to account for differences in baseline characteristics. As no RCT was identified in the literature, this study was presented to the Australian payer as the primary source of clinical evidence, upon which a cost-utility analysis was conducted.ResultsAfter PSM, the CED study demonstrated significantly more complications with TVPM versus LPM with adjusted rates of 6.5 percent and 4.6 percent (p&lt;0.001). Significant differences favoring LPM (p&lt;0.01) were observed in device breakdown (1.4% vs 2.0%), dislodgment (0.4% vs 1.2%) and infection (&lt;0.1% vs 0.6%). Based on these findings, a claim of superior safety was accepted by Medical Services Advisory Committee (MSAC) to support reimbursement. In making this decision, MSAC considered that the large sample size and propensity weighting overcame some of the potential biases and the magnitude of the benefit supported cost-effectiveness relative to TVPM.ConclusionsThe lack of a sufficiently powered RCT with an extended follow-up period can mean the impact and benefits of new technologies that reduce clinically important adverse events of relative infrequency are not formally incorporated into payer decision making, particularly where RCTs are a requirement. A well-designed observational study can provide valuable, real-world evidence to support a HTA for reimbursement decisions.

Impact of leadless pacemaker therapy on tricuspid regurgitation

Abstract Background The association between conventional transvenous pacemaker leads and tricuspid regurgitation (TR) has been well described. Leadless pacemakers (LP) have risen as an alternative to conventional transvenous pacemakers in order to avoid lead associated complications. Prior studies have included a mix of leadless pacemaker types including: Nanostim, Micra, etc. This is the first study exploring only one model of LP. Purpose The purpose of the study was to investigate the impact of leadless pacemaker therapy on tricuspid regurgitation. Methods Adult patients who underwent Micra leadless pacemaker implantation at a single center from 2016 to 2022 were identified retrospectively. Patients who had an echocardiogram prior to the procedure and within 24 months after the procedure were included. Echocardiograms were reviewed to assess for change in presence or in severity of tricuspid regurgitation. Results There were 310 patients in total who received LP at our hospital. Of these, 104 met inclusion criteria. 189 patients were excluded because they did not have an echocardiogram before or after the procedure. 17 more were excluded because their post procedure echo was done more than 2 years later. The average age of our patient population was 78. Of the 104 total patients, 97 had some TR before LP implantation (Trace 41%, Trace-Mild 4%, Mild 31%, Mild-Moderate 7%, Moderate 13%, Moderate-Severe 1%, Severe 2%). After implantation, 34 patients had worsening TR (33%), 23 patients had improved TR (22%), and 47 patients had no change in TR severity (45%) p=0.053. Conclusion Overall, the results did not show a statistically significant improvement or worsening in TR severity after LP implantation. Further studies should be done to validate these findings, to evaluate the effect of a larger sample size, and to examine whether controlling for additional confounders maintains or contradicts this finding.

Anatomic, histologic, and mechanical features of the right atrium: implications for leadless atrial pacemaker implantation.

Leadless pacemakers (LPs) may mitigate the risk of lead failure and pocket infection related to conventional transvenous pacemakers. Atrial LPs are currently being investigated. However, the optimal and safest implant site is not known. We aimed to evaluate the right atrial (RA) anatomy and the adjacent structures using complementary analytic models [gross anatomy, cardiac magnetic resonance imaging (MRI), and computer simulation], to identify the optimal safest location to implant an atrial LP human. Wall thickness and anatomic relationships of the RA were studied in 45 formalin-preserved human hearts. In vivo RA anatomy was assessed in 100 cardiac MRI scans. Finally, 3D collision modelling was undertaken assessing for mechanical device interaction. Three potential locations for an atrial LP were identified; the right atrial appendage (RAA) base, apex, and RA lateral wall. The RAA base had a wall thickness of 2.7 ± 1.6 mm, with a low incidence of collision in virtual implants. The anteromedial recess of the RAA apex had a wall thickness of only 1.3 ± 0.4 mm and minimal interaction in the collision modelling. The RA lateral wall thickness was 2.6 ± 0.9 mm but is in close proximity to the phrenic nerve and sinoatrial artery. Based on anatomical review and 3D modelling, the best compromise for an atrial LP implantation may be the RAA base (low incidence of collision, relatively thick myocardial tissue, and without proximity to relevant epicardial structures); the anteromedial recess of the RAA apex and lateral wall are alternate sites. The mid-RAA, RA/superior vena cava junction, and septum appear to be sub-optimal fixation locations.

Cardiac pacing and lead devices management.

Cardiac pacing represents a key element in the field of electrophysiology and the treatment of conduction diseases. Since the first issue published in 1999, EP Europace has significantly contributed to the development and dissemination of the research in this area. In the last 25 years, there has been a continuous improvement of technologies and a great expansion of clinical indications making the field of cardiac pacing a fertile ground for research still today. Pacemaker technology has rapidly evolved, from the first external devices with limited longevity, passing through conventional transvenous pacemakers to leadless devices. Constant innovations in pacemaker size, longevity, pacing mode, algorithms, and remote monitoring highlight that the fascinating and exciting journey of cardiac pacing is not over yet. The aim of the present review is to provide the current "state of the art" on cardiac pacing highlighting the most important contributions from the Journal in the field.

Strategies for Safe Implantation and Effective Performance of Single-Chamber and Dual-Chamber Leadless Pacemakers.

Leadless pacemakers (LPMs) have emerged as an alternative to conventional transvenous pacemakers to eliminate the complications associated with leads and subcutaneous pockets. However, LPMs still present with complications, such as cardiac perforation, dislodgment, vascular complications, infection, and tricuspid valve regurgitation. Furthermore, the efficacy of the leadless VDD LPMs is influenced by the unachievable 100% atrioventricular synchrony. In this article, we review the available data on the strategy selection, including appropriate patient selection, procedure techniques, device design, and post-implant programming, to minimize the complication rate and maximize the efficacy, and we summarize the clinical settings in which a choice must be made between VVI LPMs, VDD LPMs, or conventional transvenous pacemakers. In addition, we provide an outlook for the technology for the realization of true dual-chamber leadless and battery-less pacemakers.

Removal of a leadless pacemaker using a 2.5cc syringe and silk thread during surgical treatment of infective endocarditis

Removal of a leadless pacemaker using a 2.5cc syringe and silk thread during surgical treatment of infective endocarditis

Abstract 15363: Safety of Leadless Pacemakers vs. Transvenous Pacemakers in Patients Older Than 65 Years

Introduction: Leadless pacemakers (LP) are a less invasive option compared to conventional transvenous pacemakers (TVP). They were introduced with the hope of eliminating complications associated with TVP and leads, which are more common among the elderly population. However, evidence supporting their use is uncertain. This study aims to compare the safety of the LP compared to TVP in patients 65 and older. Methods: We retrospectively analyzed consecutive patients, aged 65 and older, who were implanted a LP or TVP between August 2017 and November 2021, in 2 experienced Cardiovascular centers. The primary endpoint was a composite of any procedure-related complication (hematoma, venous thrombosis, infections, hemothorax, device dislodgement, pneumothorax). The secondary endpoint was the need for reinterventions. Results: A total of 313 patients were included; 219 received a TVP and 94 patients received a LP. Of the TVPs implanted, 68% used cephalic access, 21% axillary and 11% subclavian. The mean age was 78.9 + 7.76 for the TVP group and 82.6 +8.83 for the LP group. A total of 23 patients in the TVP group reached the primary end point vs 4 patients in the LP group, with a relative risk reduction of 60% of procedure related complications in LP compared to TVP (risk ratio [RR]:0.4; 95% CI (0.144-1.139); P= 0.043). In addition, 8 patients in the TVP group reached the secondary outcome vs none in the LP group (3.65% vs. 0%; p= &lt;0.00001).. There were no statistically significant differences in individual outcomes between the TVP group and the LP group: incision-site hematomas (11 (5%) vs. 2 (2.1%); p=0.24), venous thrombosis (2 (2%) vs 1 (0.5 %); p=0.9), infections (1 (0.5%) vs 1 (1%) ; p=0.54), hemothorax (1 (0.5%) vs. 0 (0%); p=1), device dislodgement (8 (3.6%) vs 0 (0%); p=0.11), pneumothorax (none in either group). Conclusion: This study demonstrates that LP is a safer option than TVP among patients aged 65 and older. Additional studies are needed to further establish these findings. 1

Conventional transvenous or leadless ventricular permanent pacemakers: post-operative complications and mid-term follow-up

Abstract Introduction/Background Leadless ventricular permanent pacemakers (leadless VVI, LPM) were designed to reduce lead-related complications of conventional VVI pacemakers (CPM). Purpose The aim of our study was to assess and compare real-life clinical outcomes within the first 30 days and during a mid-term follow-up with the two techniques at a nationwide level. Methods This French longitudinal cohort study was based on the national hospitalization database covering hospital care from for the entire population. All adults (age ≥18 years) hospitalized in French hospitals From January 1, 2017 to September 1, 2020, who underwent a first LPM or CPM implantation were included. Importantly, patients with dual chamber pacemaker were not included in our study. Results Of 42,315 patients included in the cohort, 40,828 patients (96%) had a CPM and 1,487 had a LPM. Using propensity score, 1,344 patients with CPM were adequately matched in a 1:1 fashion with LPM patients. Clinical outcomes at day 30 In the unmatched population, within the 30 days after implantation, patients with LPM had a lower rate of all-cause mortality (OR: 0.635, 95% CI: 0.527–0.765, p&amp;lt;0.0001) and from a cardiovascular cause (OR: 0.568, 95% CI: 0.405–0.797, p=0.001). They also had lower rates of major bleeding and need for transfusion. There was no significant difference between groups regarding tamponade, pneumothorax or hemothorax. In the matched population, LPM implantation was still significantly associated with a lower rate of all-cause death (OR: 0.583, 95% CI: 0.456–0.744, p&amp;lt;0.0001), cardiovascular death (OR: 0.413, 95% CI: 0.271–0.629, p&amp;lt;0.0001), major bleeding (OR: 0.523, 95% CI: 0.348–0.786, p=0.002) or transfusion (OR: 0.481, 95% CI: 0.296–0.780, p&amp;lt;0.0001). However, tamponade, pneumothorax or hemothorax were not significantly different between the two groups. Clinical outcomes during mid-term follow-up In the unmatched patients, mean follow-up was 8.6±10.5 months. Annual incidence of all-cause death was high in both groups, and significantly higher in the LPM group than in CPM group (31%/year vs. 20%/year, p&amp;lt;0.0001) with a HR of 1.519 (95% CI: 1.296–1.780). Cardiovascular death was not significantly different between groups. Infective endocarditis was higher in the LPM group than in the CPM group with a HR of 2.108 (95% CI: 1.119–3.973). In the matched patients, mean follow-up was 6.2±8.7 months. All-cause death, cardiovascular death and infective endocarditis were not significantly different between groups. Conclusion Mortality is high among unselected patients implanted with ventricular permanent pacemakers, whether leadless or conventional pacemaker are used. Implantation of leadless pacemakers seems to be a safe procedure in this high-risk population, with better outcomes at 1 month. Mid-term outcomes appear relatively similar in LPM and CPM patients. Funding Acknowledgement Type of funding sources: None. Central illustration

Conventional single-chamber pacemakers versus transcatheter pacing systems in a "real world" cohort of patients: A comparative prospective single-center study.

PurposeDespite the developments in conventional transvenous pacemakers (VVI-PM), the procedure is still associated with significant complications. Although there are no prospective clinical trials that compared VVI-PM with transcatheter pacemaker systems (TPS).MethodsThis is a prospective, observational, single-center study that included all patients with an indication for a single-chamber pacemaker implant within a 4-year period. All clinical, ECG and echocardiographic characteristics at implant, electrical parameters, associated complications and mortality were analyzed. A Cox survival model and a Bayesian cohort analysis were performed for differences in complication rates between groups.ResultsThere were 443 patients included (198 TPS and 245 VVI-PM). The mean age was 81.5 years (TPS group, 79.2 ± 6.6 years; VVI-PM group, 83.5 ± 8.9 years). There was a male predominance in TPS group (123, 62.1% vs. 67, 27.3%; p < 0.001). The presence of systolic dysfunction and renal insufficiency were more frequent in VVI-PM group than in TPS patients. Mean follow-up was 22.3 ± 15.9 months. In a multivariable paired data the TPS group presented fewer complications than VVI-PM group (HR = 0.39 [0.15–0.98], p-value 0.013), but major complications were not different (6, 3% vs 14, 5.6% respectively, p = 0.1761). There was no difference in the mortality rate between the groups. The TPS group had less risk than VVI-PM group to have a complication, with a 96% of probability.ConclusionsTPS patients had a lower overall complication rate than VVI-PM patients including matched-pair samples using a Bayesian analysis. These results confirm the safety profile of TPS in clinical practice.

Assessment of injury current during leadless pacemaker implantation

BackgroundLeadless pacemakers are an established treatment option for bradyarrhythmias. Similar to conventional transvenous pacemakers, satisfying pacing values during implantation are targeted for optimal long-term device function. The objective is to investigate the role of a local injury current (IC) in leadless pacemaker implantations. MethodThe IC, sensing value, capture threshold and impedance were collected in 30 consecutive patients receiving a leadless pacemaker. Results39 EGMs were recorded from 30 patients (including 9 device repositions). An IC was detected in 15 cases (38%). At implantation, the presence of an IC was associated with a significantly lower sensing (7.1 ± 3.7 mV vs 12.0 ± 4.0 mV; P = 0.004) and a higher capture threshold (median threshold 1.13 V at 0.24 ms [0.50–2.00] vs 0.50 V at 0.24 ms [0.25–0.75]; P = 0.002) and with a 26 fold higher likelihood of device repositioning compared to the absence of an IC (OR 26.3 [2.79–248], P < 0.001). Patients with an IC in their final implant position had a lower sensing (9.3 ± 4.4 mV vs 13.6 ± 4.7 mV at implantation, P = 0.04), while the initially similar capture threshold was lower after 24 h in the IC group. After 2 weeks, all parameters were similar between the two groups. ConclusionsOur study shows that an IC can readily be observed during leadless pacemaker implantation associated with a lower sensing and a higher capture threshold at implantation but with similar to even better values during follow-up.

Safety and efficacy of leadless pacemaker for cardioinhibitory vasovagal syncope

Single-chamber leadless pacemakers (LPs) have been shown to be an effective alternative to conventional transvenous pacemakers (CTPs), but their benefit in the context of cardioinhibitory vasovagal syncope (CI-VVS) is unknown. The purpose of this study was to evaluate the safety and efficacy of LP compared with dual-chamber CTP for CI-VVS. We conducted a multicenter, retrospective study comparing patients who received LP or dual-chamber CTP for drug-refractory CI-VVS. CI-VVS was diagnosed clinically and supported by cardiac monitoring and head-up tilt table testing. The primary efficacy endpoint was freedom from syncope during follow-up. Secondary endpoints included device efficacy and safety estimated by device-related major and minor adverse events (AEs). Seventy-two patients (24 LP, 48 CTP; age 32 ± 5.5 years; 90% female; syncope frequency 7.6 ± 3.4 per year) were included. At 1 year, 91% of patients (22/24) in the LP group and 94% of patients (43/48) in the CTP group met the primary efficacy endpoint (P = .7). Device efficacy endpoint was met in 92% of the LP group and 98% of the CTP group (P = .2). Early major AEs occurred in 2 of 24 in the LP group and 3 of 48 in the CTP group (P = .4). Late major AEs occurred in 0 of 24 in the LP group and 2 of 48 in the CTP group (P = 1). In patients with CI-VVS, single-chamber LP demonstrated equivalent efficacy in reducing syncopal events compared to dual-chamber CTP, with a similar safety profile.

Rendimiento del marcapasos cardiaco Micra en nonagenarios

Introduction and objectivesThe Micra transcatheter pacing system has shown high effectiveness and a lower complication rate than conventional transvenous pacemakers. However, the benefit of the device is unknown in the very old population (≥ 90 years). The aim of this study was to evaluate the safety and effectiveness of Micra in patients ≥ 90 years. MethodsWe present a prospective observational study with consecutive patients aged >70 years who underwent implantation of a Micra pacemaker system. Patients were divided into 2 groups: ≥ 90 and<90 years. ResultsThe Micra system was implanted in 129 patients, of whom 41 were aged ≥ 90 years and 88<90 years. The device was successfully implanted in 40 (97.6%) patients ≥ 90 years and in 87 (98.9%) patients<90 years (P=.58). An adequate position was achieved with need for ≤ 2 repositions in 97.5% and 91.9% of patients, respectively (P=.32). Procedure time (26.1 ±11.6 vs 30.3 ±14.2minutes; P=.11) and fluoroscopy time (6.4 ±4.7 vs 7.2 ±4.9minutes; P=0.41) were similar in the 2 groups. There were 3 major complications (2.3%), all in the group aged<90 years: 1 cardiac perforation, 1 femoral hematoma, and 1 femoral pseudoaneurysm. Thirteen patients aged ≥ 90 years (31.7%) and 16 patients aged <90 years (18.2%) died during a mean follow-up of 230±233 days and 394±285 days, respectively. There were no device-related deaths. No infection, dislocation or migration of Micra were observed. The electrical performance was optimal at follow-up. ConclusionsThe Micra leadless pacing system seems to be safe and effective in patients older than 90 years. It may be considered a reasonable alternative to conventional transvenous pacing in this population.Full English text available from: www.revespcardiol.org/en

Performance of the Micra cardiac pacemaker in nonagenarians

The Micra transcatheter pacing system has shown high effectiveness and a lower complication rate than conventional transvenous pacemakers. However, the benefit of the device is unknown in the very old population (≥ 90 years). The aim of this study was to evaluate the safety and effectiveness of Micra in patients ≥ 90 years. We present a prospective observational study with consecutive patients aged >70 years who underwent implantation of a Micra pacemaker system. Patients were divided into 2 groups: ≥ 90 and<90 years. The Micra system was implanted in 129 patients, of whom 41 were aged ≥ 90 years and 88<90 years. The device was successfully implanted in 40 (97.6%) patients ≥ 90 years and in 87 (98.9%) patients<90 years (P=.58). An adequate position was achieved with need for ≤ 2 repositions in 97.5% and 91.9% of patients, respectively (P=.32). Procedure time (26.1 ±11.6 vs 30.3 ±14.2minutes; P=.11) and fluoroscopy time (6.4 ±4.7 vs 7.2 ±4.9minutes; P=0.41) were similar in the 2 groups. There were 3 major complications (2.3%), all in the group aged<90 years: 1 cardiac perforation, 1 femoral hematoma, and 1 femoral pseudoaneurysm. Thirteen patients aged ≥ 90 years (31.7%) and 16 patients aged <90 years (18.2%) died during a mean follow-up of 230±233 days and 394±285 days, respectively. There were no device-related deaths. No infection, dislocation or migration of Micra were observed. The electrical performance was optimal at follow-up. The Micra leadless pacing system seems to be safe and effective in patients older than 90 years. It may be considered a reasonable alternative to conventional transvenous pacing in this population.

Safety and Efficacy of Leadless Pacemakers: A New Era of Pacing.

Leadless pacemakers are evolving as a new technologic alternative to conventional transvenous pacemakers, though potential short-term and long-term complications have been recognized. The two currently available right ventricular leadless pacing systems are the Nanostim™ Leadless Cardiac Pacemaker (Abbott Laboratories, Chicago, IL, USA) and the Micra™ Transcatheter Pacing System (Medtronic, Minneapolis, MN, USA). This review aims to highlight the safety and efficacy of leadless pacemakers using these two devices as exemplars.

Anesthetic Management of a Patient With a Leadless Pacemaker Undergoing Cardiac Surgery

EVERY YEAR, more than 1 million pacemakers are inserted worldwide, with over 260,000 implanted in the United States. 1 Mond HG Proclemer A The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009–a World Society of Arrhythmia's project. Pacing Clin Electrophysiol. 2011; 34: 1013-1027 Crossref PubMed Scopus (655) Google Scholar Despite advancements in the technology of conventional transvenous pacemakers, procedural risks involving insertion and removal of the device—such as lead dislodgement, lead fracture, infection, cardiac tamponade, and thrombosis—remain. In an attempt to reduce such risks and provide a less invasive option for patients needing ventricular pacing, leadless pacemakers (LPs) were developed and are being introduced to the market. 2 Tjong FV Reddy VY Permanent leadless cardiac pacemaker therapy: A comprehensive review. Circulation. 2017; 135: 1458-1470 Crossref PubMed Scopus (128) Google Scholar

Safety and feasibility of leadless pacemaker in patients undergoing atrioventricular node ablation for atrial fibrillation

Atrioventricular node (AVN) ablation and permanent pacing is an established strategy for rate control in the management of symptomatic atrial fibrillation (AF). Leadless pacemakers (LPs) can overcome some of the short-term and long-term limitations of conventional transvenous pacemakers (CTPs). The purpose of this study was to compare the feasibility and safety of LP with those of single-chamber CTP in patients with AF undergoing AVN ablation. We conducted a multicenter observational study of patients undergoing AVN ablation and pacemaker implantation (LP vs single-chamber CTP) between February 1, 2014 and November 15, 2016. The primary efficacy end points were acceptable sensing (Rwave amplitude ≥5.0 mV) and pacing thresholds (≤2.0 V at 0.4 ms) at follow-up. Safety end points included device-related major and minor (early <1 month, late >1 month) adverse events. A total of 127 patients with LP (n = 60) and CTP (n = 67) were studied. The median follow-up was 12 months (interquartile range 12-18 months). Ninety-five percent of the LP group and 97% of the CTP group met the primary efficacy end point at follow-up (57 of 60 vs 65 of 67; P = .66). There was 1 major adverse event (loss of pacing and sensing) in the LP group and 2 (lead dislodgement) in the CTP group (1 of 60 vs 2 of 67; P = 1.00). There were 6 minor adverse events (5 early and 1 late) in the LP group and 3 (early) in the CTP group (6 of 60 vs 3 of 67; P = .30). Our results demonstrate the feasibility and safety of LP compared with CTP in patients undergoing AVN ablation for AF.