Pediatric Micra leadless pacemaker implantation via internal jugular and femoral vein: a single center, US experience

Background: In the pediatric population, conventional transvenous and epicardial pacemaker systems carry complications such as lead distortion due to growth/activity, in addition to other lead/pocket complications. Materials & methods: A retrospective review of pediatric leadless pacing at the University of Minnesota Masonic Children’s Hospital from 2018 to 2020 was performed. Rationale for pacing, demographics of patients, thresholds and longevity of devices were recorded. Results: Seven leadless pacemaker insertions and one removal were performed successfully, in patients weighing between 19 kg and 58 kg. Three patients had Micra implantation via internal jugular vein. One pericardial effusion occurred perioperatively in a 19 kg patient with baseline thrombocytopenia, sideroblastic anemia and Pearson Marrow Pancreas syndrome. Conclusion: Leadless pacemaker implantation/early retrieval is feasible in pediatric patients.

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Premature ventricular contraction–induced polymorphic ventricular tachycardia after leadless pacemaker implantation: A unique adverse effect of leadless pacing

HeartRhythm Case Reports ◽

10.1016/j.hrcr.2018.01.006 ◽

2018 ◽

Vol 4 (5) ◽

pp. 180-183 ◽

Cited By ~ 6

Author(s):

Anish K. Amin ◽

Sreedhar R. Billakanty ◽

Nagesh Chopra ◽

Eugene Y. Fu ◽

Allan J. Nichols ◽

...

Keyword(s):

Adverse Effect ◽

Ventricular Tachycardia ◽

Pacemaker Implantation ◽

Premature Ventricular Contraction ◽

Polymorphic Ventricular Tachycardia ◽

Ventricular Contraction ◽

Leadless Pacemaker ◽

Leadless Pacing

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Direct Femoral Vein Leadless Pacemaker Implantation

JACC: Clinical Electrophysiology ◽

10.1016/j.jacep.2019.01.012 ◽

2019 ◽

Vol 5 (5) ◽

pp. 639-640

Author(s):

James Gabriels ◽

Joseph Donnolly ◽

Stuart Beldner ◽

Jonathan Willner ◽

Omid Rahmani ◽

...

Keyword(s):

Femoral Vein ◽

Pacemaker Implantation ◽

Leadless Pacemaker

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First description of a successful leadless pacemaker implantation via the left internal jugular vein (in a 20 kg patient)

Journal of Electrocardiology ◽

10.1016/j.jelectrocard.2020.02.020 ◽

2020 ◽

Vol 60 ◽

pp. 1-2 ◽

Cited By ~ 1

Author(s):

Abdul Kader Surti ◽

Matthew Ambrose ◽

Daniel Cortez

Keyword(s):

Internal Jugular Vein ◽

Jugular Vein ◽

Pacemaker Implantation ◽

Left Internal Jugular Vein ◽

Leadless Pacemaker

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A model for overcoming challenges in academic pediatric medical device innovation

Journal of Clinical and Translational Science ◽

10.1017/cts.2019.370 ◽

2019 ◽

Vol 3 (1) ◽

pp. 5-11

Author(s):

Gwenyth A. Fischer ◽

Sandra M. Wells ◽

Jodi F. Rebuffoni ◽

Brittni M. Peterson ◽

Tucker W. LeBien

Keyword(s):

Medical Device ◽

Pediatric Patients ◽

Technology Development ◽

Academic Institution ◽

University Of Minnesota ◽

Successful Model ◽

Small Market ◽

The Usa ◽

The University ◽

Patient Use

AbstractTechnological advancements in medical devices developed for adults far outpace the development of technologies designed for pediatric patients in the USA and other countries. This technology lag was previously reflected in a lack of pediatric-specific innovation within our academic institution. To address the institutional deficit of device innovation around pediatric patients, we formed unique partnerships both within our university and extending to the medical device industry, and developed novel programmatic approaches. The Pediatric Device Innovation Consortium (PDIC) bridges the medical device community and the University of Minnesota. Since 2014, the PDIC has supported 22 pediatric medical technology innovation projects, provided funds totaling more than $500,000, licensed two technologies, and advanced two technologies to patient use. Here, we describe the PDIC model and method, the PDIC approach to common challenges that arise in the development of small-market medical technologies at an academic institution, and iterations to our collaborative, multidisciplinary approach that have matured throughout our experience. The PDIC model continues to evolve to reflect the special needs of innovation for smaller markets and the unique role of clinician innovators. Our approach serves as a successful model for other institutions interested in creating support mechanisms for pediatric or small-market technology development.

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

EP Europace ◽

10.1093/europace/euaa162.376 ◽

2020 ◽

Vol 22 (Supplement_1) ◽

Author(s):

M Abbas ◽

L Whittaker ◽

M Chapman ◽

A R Thornley ◽

D Towmey ◽

...

Keyword(s):

Femoral Vein ◽

Pacemaker Implantation ◽

Fluoroscopy Time ◽

Categorical Variables ◽

Exact Test ◽

Single Procedure ◽

Leadless Pacemaker ◽

Laboratory Time ◽

Puncture Technique ◽

Group 1

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

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Left femoral venous access for leadless pacemaker implantation: patient characteristics and outcomes

EP Europace ◽

10.1093/europace/euab116.377 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

J Jelisejevas ◽

A Breitenstein ◽

D Hofer ◽

S Winnik ◽

J Steffel ◽

...

Keyword(s):

Pacemaker Implantation ◽

Patient Characteristics ◽

Venous Access ◽

Femoral Access ◽

Funding Sources ◽

Leadless Pacemaker ◽

Leadless Pacing ◽

Procedural Success ◽

The Right ◽

Transfemoral Tavi

Abstract Funding Acknowledgements Type of funding sources: None. Background Leadless pacing has become an alternative approach for patients requiring a single-chamber pacemaker. Conventionally, Leadless Micra Transcatheter Pacing System (TPS) pacemakers are implanted via a right femoral venous access. However, due to various reasons, a left sided femoral venous approach may benecessary. We hypothesized that a left sided femoral venous approach is as safe and effective as compared to a right sided approach. Objective We assessed indications, procedural characteristics, safety and mid-term outcomes of Micra TPS implantation via a left femoral venous approach as compared to the conventional right sided approach. Methods and Results: In this retrospective single-center analysis, 143 consecutive patients undergoing Micra TPS implantation were included. 87% (125/143) underwent Micra TPS implantation via a right, and 13% (18/143) via a left femoral venous access. The mean age at implantation was 79.8 ± 7.5 years. Acute procedural success, mean procedure and fluoroscopy times as well as device parameters at implantation and follow-up (mean 15 ± 11.5 months) were similar between the two groups. Five major complications (3.5%) were encountered, all using a right-sided approach. After a transfemoral TAVI procedure, left femoral venous access was used in 42% of cases as compared to 8% in the remaining population (p = 0.003). Final leadless pacemaker position within the right ventricle was mid-septal in 82% (102/125) for right femoral access vs 72% (13/18) for left femoral access (p = 0.16). In the remaining cases (28 %, 5/18), the device was placed infero-septal following a left femoral venous access, as compared to 14% (18/125) for a right sided approach (p = 0.19). No repositioning was needed in 68% (85/125) using a right femoral access vs 72% (13/ 18) patients with a left femoral access (p = 0.84). Conclusions A left femoral venous access for Micra TPS implantation is safe and effective with an excellent implantation success rate similar to a conventional right femoral venous access without longer implantation and fluoroscopy times. The most frequent reason for choosing left- vs. right femoral venous access was a previous transfemoral TAVI procedure.

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Ventricular Fibrillation Cardiopulmonary Arrest Following Micra Leadless Pacemaker Implantation

10.22541/au.160691426.63340870/v1 ◽

2020 ◽

Author(s):

Nausharwan Butt ◽

Huzaifa Ahmad ◽

Vijaywant Brar ◽

Vishaka Chetram ◽

Arooge Towheed ◽

...

Keyword(s):

Ventricular Fibrillation ◽

Cardiac Tamponade ◽

Ventricular Arrhythmias ◽

Cardiopulmonary Arrest ◽

Pacemaker Implantation ◽

Cardiac Pacemakers ◽

Leadless Pacemaker ◽

Leadless Pacing

Leadless cardiac pacemakers such as the Micra transcatheter leadless pacing system provide an alternative to traditional transvenous pacemakers. Implantation of leadless pacemakers, albeit safe may be associated with complications including cardiac tamponade, high capture thresholds, and rarely, ventricular arrhythmias. We report a case of ventricular fibrillation arrest following Micra leadless pacemaker implantation.

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Left femoral venous access for leadless pacemaker implantation: patient characteristics and outcomes

EP Europace ◽

10.1093/europace/euab083 ◽

2021 ◽

Author(s):

Julius Jelisejevas ◽

Alexander Breitenstein ◽

Daniel Hofer ◽

Stephan Winnik ◽

Jan Steffel ◽

...

Keyword(s):

Pacemaker Implantation ◽

Patient Characteristics ◽

Venous Access ◽

Leadless Pacemaker ◽

Alternative Approach ◽

Leadless Pacing ◽

Procedural Success ◽

Transfemoral Tavi ◽

Frequent Reason

Abstract Aims Leadless pacing has become an alternative approach for patients requiring a single-chamber pacemaker. Conventionally, leadless Micra Transcatheter Pacing System (TPS) pacemakers are implanted via a right femoral venous access. However, due to various reasons, a left-sided femoral venous approach may be necessary. We hypothesized that a left-sided femoral venous approach is as safe and effective when compared with a right-sided approach. We assessed indications, procedural characteristics, safety and mid-term outcomes of Micra TPS implantation via a left femoral venous approach when compared with the conventional right-sided approach. Methods and results In this retrospective single-centre analysis, 143 consecutive patients undergoing Micra TPS implantation were included. 87% (125/143) underwent Micra TPS implantation via a right, and 13% (18/143) via a left femoral venous access. The mean age at implantation was 79.8 ± 7.5 years. Acute procedural success, mean procedure and fluoroscopy times as well as device parameters at implantation and follow-up (mean 15 ± 11.5 months) were similar between the two groups. Five major complications (3.5%) were encountered, all using a right-sided approach. After a transfemoral TAVI procedure, left femoral venous access was used in 42% of cases when compared with 8% in the remaining population (P = 0.003). Conclusions A left femoral venous access for Micra TPS implantation is safe and effective with an excellent implantation success rate similar to a conventional right femoral venous access without longer implantation and fluoroscopy times. The most frequent reason for choosing left vs. right femoral venous access was a previous transfemoral TAVI procedure.

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Insufficient procedural anticoagulation during leadless pacing led to catheter-related thrombosis in a hemodialysis patient

BMC Cardiovascular Disorders ◽

10.1186/s12872-021-02318-6 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Qiang Chen ◽

Yong Jiang Ma ◽

Chun Hong Zhang ◽

Li Wei Zhang

Keyword(s):

Hemodialysis Patient ◽

Thrombus Formation ◽

Pacemaker Implantation ◽

Case Presentation ◽

Leadless Pacemaker ◽

Procedural Complications ◽

Diabetic Gangrene ◽

Leadless Pacing ◽

Catheter Related Thrombosis ◽

Delivery Catheter

Abstract Background Leadless pacemaker was a promising innovation than traditional transvenous pacemaker, the procedural complications were prone to be bleeding-related. However, very few reports also concerned about the thrombus formation during the procedure. Case presentation A hemodialysis patient with diabetic gangrene of right foot suffered from catheter-related thrombosis during leadless pacing, resulting in failure of recapture the pacemaker. A low activated clotting time (ACT) level of 104 s confirmed the insufficiency of anticoagulation. Finally, the whole delivery catheter had to be removed from the delivery sheath, another new pacemaker system was applied and successfully implanted after adjusting the ACT level to 248 s. Conclusion Catheter-related thrombosis could be a large obstacle for leadless pacemaker implantation. In addition to routine anticoagulation, ACT monitoring might be necessary during the procedure.

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