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Reinoud E Knops - One of the best experts on this subject based on the ideXlab platform.

  • impact of Leadless Pacemaker therapy on cardiac and atrioventricular valve function through 12 months of follow up
    Circulation-arrhythmia and Electrophysiology, 2019
    Co-Authors: Niek E.g. Beurskens, Fleur V Y Tjong, Arthur A M Wilde, Kosse J Dasselaar, Wichert J Kuijt, Rianne H A C M De Bruinbon, Reinoud E Knops
    Abstract:

    BACKGROUND: Endocardial Pacemaker leads and right ventricular (RV) pacing are well-known causes of tricuspid valve, mitral valve, and cardiac dysfunction. Lead-related adverse consequences can potentially be mitigated by Leadless Pacemaker (LP) therapy by eliminating the presence of a transvalvular lead. This study assessed the impact of LP placement on cardiac and valvular structure and function. METHODS: Echocardiographic studies before and 12±1 months after LP implantation were performed between January 2013 and May 2018 at our center and compared with age- and sex-matched controls of dual-chamber transvenous Pacemaker recipients. RESULTS: A total of 53 patients receiving an LP were included, of whom 28 were implanted with a Nanostim and 25 with a Micra LP device. Tricuspid valve regurgitation was graded as being more severe in 23 (43%) patients at 12±1 months compared with baseline ( P<0.001). Compared with an apical position, an RV septal position of the LP was associated with increased tricuspid valve incompetence (odds ratio, 5.20; P=0.03). An increase in mitral valve regurgitation was observed in 38% of patients ( P=0.006). LP implantation resulted in a reduction of RV function, according to a lower tricuspid annular plane systolic excursion ( P=0.003) and RV tricuspid lateral annular systolic velocity ( P=0.02), and a higher RV Tei index ( P=0.04). LP implantation was further associated with a reduction of left ventricular ejection fraction ( P=0.03) and elevated left ventricular Tei index ( P=0.003). The changes in tricuspid valve regurgitation in the LP group were similar to the changes in the dual-chamber transvenous Pacemaker control group (43% versus 38%, respectively; P=0.39). CONCLUSIONS: LP therapy is associated with an increase in tricuspid valve dysfunction through 12 months of follow-up; yet it was comparable to dual-chamber transvenous Pacemaker systems. Furthermore, LP therapy seems to adversely impact mitral valve and biventricular function.

  • Leadless Pacemaker implantation after explantation of infected conventional Pacemaker systems a viable solution
    Heart Rhythm, 2019
    Co-Authors: Niek E.g. Beurskens, Fleur V Y Tjong, Arthur A M Wilde, Kosse J Dasselaar, Wichert J Kuijt, Reinoud E Knops
    Abstract:

    Background Conventional cardiac device infections are increasing in incidence, causing significant morbidity and mortality. Leadless Pacemaker (LP) therapy may provide new opportunities for the management of Pacemaker (PM) infections as it does not require implantation of transvenous leads and a pectoral pocket. Objective We sought to evaluate the effect of early and late LP implantation in patients diagnosed with device infection. Methods Patients receiving an LP at our center after conventional PM lead extraction due to infection between December 1, 2013 and November 30, 2017 were included. Results A total of 17 patients (mean age 77.4 ± 7.77 years) underwent LP implantation (ie, 11 with Nanostim Leadless cardiac Pacemaker [Abbott, Chicago, IL] and 6 with Micra transcatheter pacing system [Medtronic, Minneapolis, MN]) after successful PM system explantation. In 9 PM-dependent patients, a temporary transvenous pacing system was placed as a bridge to permanent LP implantation. Early LP implantation was performed in 6 patients ( 1 week). All patients experienced no LP infection during a mean follow-up of 16 ± 12 months, including 7 patients with a history of recurrent device infections with a mean follow-up of 20 ± 14 months. Conclusion Early and late LP placement after infected conventional pacing system explantation was a viable option in our case series. This therapy may provide an alternative strategy in the management of device infection, if confirmed by subsequent prospective randomized trials, particularly for patients who are PM dependent or have a history of recurrent device infections.

  • device orientation of a Leadless Pacemaker and subcutaneous implantable cardioverter defibrillator in canine and human subjects and the effect on intrabody communication
    Europace, 2018
    Co-Authors: Annefloor B E Quast, Fleur V Y Tjong, Reinoud E Knops, Arthur A M Wilde, Brendan E Koop, Martin C Burke
    Abstract:

    Aims: The development of communicating modular cardiac rhythm management systems relies on effective intrabody communication between a subcutaneous implantable cardioverter-defibrillator (S-ICD) and a Leadless Pacemaker (LP), using conducted communication. Communication success is affected by the LP and S-ICD orientation. This study is designed to evaluate the orientation of the LP and S-ICD in canine subjects and measure success and threshold of intrabody communication. To gain more human insights, we will explore device orientation in LP and S-ICD patients. Methods and results: Canine subjects implanted with a prototype S-ICD and LP (both Boston Scientific, MA, USA) with anterior-posterior fluoroscopy images were included in this analysis. For comparison, a retrospective analysis of human S-ICD and LP patients was performed. The angle of the long axis of the LP towards the vertical axis of 0°, and distance between the coil and LP were measured. Twenty-three canine subjects were analysed. Median angle of the LP was 29° and median distance of the S-ICD coil to LP was 0.8 cm. All canine subjects had successful communication. The median communicating threshold was 2.5 V. In the human retrospective analysis, 72 LP patients and 100 S-ICD patients were included. The mean angle of the LP was 56° and the median distance between the S-ICD coil and LP was 4.6 cm. Conclusion: Despite the less favourable LP orientation in canine subjects, all communication attempts were successful. In the human subjects, we observed a greater and in theory more favourable LP angle towards the communication vector. These data suggests suitability of human anatomy for conductive intrabody communication.

  • a worldwide experience of the management of battery failures and chronic device retrieval of the nanostim Leadless Pacemaker
    Heart Rhythm, 2017
    Co-Authors: Dhanunjaya Lakkireddy, Derek V. Exner, Paul A. Friedman, John H. Ip, Petr Neuzil, Reinoud E Knops, Pascal Defaye, Brett D Atwater, Elkin Gonzalez, Kazutaka Aonuma
    Abstract:

    Background The Nanostim Leadless Pacemaker (LP) met the primary endpoints in an investigational device exemption trial, and was shown to be fully retrievable percutaneously. In October 2016, St Jude Medical issued a worldwide alert of a battery malfunction that caused lost pacing output and LP communication. Objective To report the battery failure mechanism and incidence and the worldwide patient management, including device retrieval experiences. Methods The affected LP battery is a custom lithium–carbon monofluoride cell. These were returned after failure and underwent analysis assessing electronics and battery performance. Data were collected in ongoing clinical studies when LPs were abandoned or retrieved. Results Of 1423 LPs implanted worldwide, there were 34 battery failures, occurring at 2.9 ± 0.4 years with no instances of associated patient injury. Analysis of returned batteries revealed an increase in battery resistance caused by insufficient electrolyte availability at the cathode/anode interface. A total of 66 of 73 retrieval attempts were successful (90.4%; implant duration range: 0.2–4.0 years). The LP docking button was inaccessible in 6 patients, and the docking button detached from the LP during retrieval in 1 patient. There was 1 case of arteriovenous fistula and another case of the LP docking button migrating into the pulmonary artery. There were also 115 non-LP retrieval patients after the advisory who received an additional Pacemaker, with no adverse device-to-device interactions reported. Conclusion As with standard pacers, LPs can have critical battery failures. Chronic retrieval of LPs is safe and efficacious.

  • end of life management of Leadless cardiac Pacemaker therapy
    Arrhythmia and Electrophysiology Review, 2017
    Co-Authors: Niek E.g. Beurskens, Fleur V Y Tjong, Reinoud E Knops
    Abstract:

    : The clinically available Leadless Pacemakers for patients with a single-chamber pacing indication have shown to be safe and effective. However, the optimal end-of-life strategy of this novel technique is undefined. Suggested strategies comprise of (a) placing an additional Leadless device adjacent to the Leadless Pacemaker, or (b) retrieving the non-functioning Leadless Pacemaker and subsequently implanting a new device. Although initial studies demonstrate promising results, early experience of acute and mid-term retrieval feasibility and safety remains mixed. We suggest that the approach of Leadless Pacemaker retrieval is more appealing to limit the amount of non-functioning intracardiac hardware. In addition, potential risks for device-device interference, and unknown long-term complications associated with multiple intracardiac devices are prevented. The potential inability to retrieve chronically implanted Leadless Pacemakers limits the application of this novel technology. Therefore, long-term prospective analysis is required to define the most optimal end-of-life strategy.

Fleur V Y Tjong - One of the best experts on this subject based on the ideXlab platform.

  • impact of Leadless Pacemaker therapy on cardiac and atrioventricular valve function through 12 months of follow up
    Circulation-arrhythmia and Electrophysiology, 2019
    Co-Authors: Niek E.g. Beurskens, Fleur V Y Tjong, Arthur A M Wilde, Kosse J Dasselaar, Wichert J Kuijt, Rianne H A C M De Bruinbon, Reinoud E Knops
    Abstract:

    BACKGROUND: Endocardial Pacemaker leads and right ventricular (RV) pacing are well-known causes of tricuspid valve, mitral valve, and cardiac dysfunction. Lead-related adverse consequences can potentially be mitigated by Leadless Pacemaker (LP) therapy by eliminating the presence of a transvalvular lead. This study assessed the impact of LP placement on cardiac and valvular structure and function. METHODS: Echocardiographic studies before and 12±1 months after LP implantation were performed between January 2013 and May 2018 at our center and compared with age- and sex-matched controls of dual-chamber transvenous Pacemaker recipients. RESULTS: A total of 53 patients receiving an LP were included, of whom 28 were implanted with a Nanostim and 25 with a Micra LP device. Tricuspid valve regurgitation was graded as being more severe in 23 (43%) patients at 12±1 months compared with baseline ( P<0.001). Compared with an apical position, an RV septal position of the LP was associated with increased tricuspid valve incompetence (odds ratio, 5.20; P=0.03). An increase in mitral valve regurgitation was observed in 38% of patients ( P=0.006). LP implantation resulted in a reduction of RV function, according to a lower tricuspid annular plane systolic excursion ( P=0.003) and RV tricuspid lateral annular systolic velocity ( P=0.02), and a higher RV Tei index ( P=0.04). LP implantation was further associated with a reduction of left ventricular ejection fraction ( P=0.03) and elevated left ventricular Tei index ( P=0.003). The changes in tricuspid valve regurgitation in the LP group were similar to the changes in the dual-chamber transvenous Pacemaker control group (43% versus 38%, respectively; P=0.39). CONCLUSIONS: LP therapy is associated with an increase in tricuspid valve dysfunction through 12 months of follow-up; yet it was comparable to dual-chamber transvenous Pacemaker systems. Furthermore, LP therapy seems to adversely impact mitral valve and biventricular function.

  • Leadless Pacemaker implantation after explantation of infected conventional Pacemaker systems a viable solution
    Heart Rhythm, 2019
    Co-Authors: Niek E.g. Beurskens, Fleur V Y Tjong, Arthur A M Wilde, Kosse J Dasselaar, Wichert J Kuijt, Reinoud E Knops
    Abstract:

    Background Conventional cardiac device infections are increasing in incidence, causing significant morbidity and mortality. Leadless Pacemaker (LP) therapy may provide new opportunities for the management of Pacemaker (PM) infections as it does not require implantation of transvenous leads and a pectoral pocket. Objective We sought to evaluate the effect of early and late LP implantation in patients diagnosed with device infection. Methods Patients receiving an LP at our center after conventional PM lead extraction due to infection between December 1, 2013 and November 30, 2017 were included. Results A total of 17 patients (mean age 77.4 ± 7.77 years) underwent LP implantation (ie, 11 with Nanostim Leadless cardiac Pacemaker [Abbott, Chicago, IL] and 6 with Micra transcatheter pacing system [Medtronic, Minneapolis, MN]) after successful PM system explantation. In 9 PM-dependent patients, a temporary transvenous pacing system was placed as a bridge to permanent LP implantation. Early LP implantation was performed in 6 patients ( 1 week). All patients experienced no LP infection during a mean follow-up of 16 ± 12 months, including 7 patients with a history of recurrent device infections with a mean follow-up of 20 ± 14 months. Conclusion Early and late LP placement after infected conventional pacing system explantation was a viable option in our case series. This therapy may provide an alternative strategy in the management of device infection, if confirmed by subsequent prospective randomized trials, particularly for patients who are PM dependent or have a history of recurrent device infections.

  • The learning curve associated with the implantation of the Nanostim Leadless Pacemaker
    Journal of Interventional Cardiac Electrophysiology, 2018
    Co-Authors: Fleur V Y Tjong, Petr Neuzil, Niek E.g. Beurskens, Pascal Defaye, Peter-paul Delnoy, John Ip, Juan Jose Garcia Guerrero, Mayer Rashtian, Rajesh Banker, Vivek Reddy
    Abstract:

    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  

  • device orientation of a Leadless Pacemaker and subcutaneous implantable cardioverter defibrillator in canine and human subjects and the effect on intrabody communication
    Europace, 2018
    Co-Authors: Annefloor B E Quast, Fleur V Y Tjong, Reinoud E Knops, Arthur A M Wilde, Brendan E Koop, Martin C Burke
    Abstract:

    Aims: The development of communicating modular cardiac rhythm management systems relies on effective intrabody communication between a subcutaneous implantable cardioverter-defibrillator (S-ICD) and a Leadless Pacemaker (LP), using conducted communication. Communication success is affected by the LP and S-ICD orientation. This study is designed to evaluate the orientation of the LP and S-ICD in canine subjects and measure success and threshold of intrabody communication. To gain more human insights, we will explore device orientation in LP and S-ICD patients. Methods and results: Canine subjects implanted with a prototype S-ICD and LP (both Boston Scientific, MA, USA) with anterior-posterior fluoroscopy images were included in this analysis. For comparison, a retrospective analysis of human S-ICD and LP patients was performed. The angle of the long axis of the LP towards the vertical axis of 0°, and distance between the coil and LP were measured. Twenty-three canine subjects were analysed. Median angle of the LP was 29° and median distance of the S-ICD coil to LP was 0.8 cm. All canine subjects had successful communication. The median communicating threshold was 2.5 V. In the human retrospective analysis, 72 LP patients and 100 S-ICD patients were included. The mean angle of the LP was 56° and the median distance between the S-ICD coil and LP was 4.6 cm. Conclusion: Despite the less favourable LP orientation in canine subjects, all communication attempts were successful. In the human subjects, we observed a greater and in theory more favourable LP angle towards the communication vector. These data suggests suitability of human anatomy for conductive intrabody communication.

  • the learning curve associated with the implantation of the nanostim Leadless Pacemaker
    Journal of Interventional Cardiac Electrophysiology, 2018
    Co-Authors: Fleur V Y Tjong, John H. Ip, Petr Neuzil, Niek E.g. Beurskens, Pascal Defaye, Peter-paul Delnoy, Juan Jose Garcia Guerrero, Mayer Rashtian, Rajesh Banker, Vivek Y. Reddy
    Abstract:

    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. 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. 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). 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.

Menachem M Weiner - One of the best experts on this subject based on the ideXlab platform.

  • Leadless Pacemaker implantation under direct visualization during valve surgery
    The Journal of Thoracic and Cardiovascular Surgery, 2020
    Co-Authors: Poojita Shivamurthy, Marc A Miller, Ahmed Eleshmawi, Percy Boateng, Dimosthenis Pandis, Amit Pawale, Dror Leviner, Ana Claudia Costa, Chartaroon Rimsukcharoenchai, Menachem M Weiner
    Abstract:

    Abstract Objective The Leadless cardiac Pacemaker is typically implanted percutaneously, and has been widely used for patients who have already undergone valve surgery. We sought to determine the feasibility and safety of implanting the Leadless Pacemaker under direct visualization during valve surgery. Methods Retrospective analysis of consecutive adult patients (n=15) who underwent implantation of a Leadless Pacemaker under direct visualization at the time of valve surgery. Indications for single-chamber pacing were sick sinus syndrome with pauses (53.3%), atrial fibrillation with slow ventricular rates (13.3%) or complete heart block (6.6%) and elevated risk for post-operative heart block (26.6%). Leadless Pacemaker performance and pacing-percentage were assessed. Results The cohort was 67.5±17 years old, 6 (40%) were males and 14 (93%) had atrial fibrillation. Isolated tricuspid valve replacement was performed in 5 (33.3%), the remainder underwent multi-valve surgery which included concomitant tricuspid valve repair/replacement. In 93% of the patients (n=14), the immediate post-CPB pacing thresholds were normal (≤2.0 V @ 0.24 ms), and normalized in the remaining patient by the next morning. The impedance/sensing values were normal and stable thru follow-up (151 ± 119 days) in all patients. Reliable Leadless Pacemaker performance allowed for allowed deferral of temporary epicardial wires in 11 patients (73%). There were no procedural complications or device malfunction. Conclusions Leadless cardiac Pacemaker implantation during valve surgery is feasible and safe. This hybrid approach to pacing may simplify the peri-operative management of patients undergoing valve surgery who have an indication for single-chamber pacing.

Anand D Shah - One of the best experts on this subject based on the ideXlab platform.

  • outcomes of micra Leadless Pacemaker implantation with uninterrupted anticoagulation
    Journal of Cardiovascular Electrophysiology, 2019
    Co-Authors: Soroosh Kiani, George B Black, Nancy Thakkar, Christopher Massad, Faisal M Merchant, Michael H Hoskins, Anshul M Patel, Akshar V Patel, David De Lurgio, Anand D Shah
    Abstract:

    BACKGROUND Implantation of the MICRA Leadless Pacemaker requires the use of a 27 French introducer, blunt delivery system and device fixation to the myocardium via nitinol tines. While prior studies have proven its safety, it is unclear whether performing this procedure with uninterrupted anticoagulation exposes patients to increased risks. We sought to investigate the feasibility and safety of continuing therapeutic anticoagulation during the periprocedural period. METHODS We evaluated all patients undergoing MICRA placement at our institution between April 2014 and August 2018 with complete follow-up data (n = 170). Patients were stratified into two groups: those on active anticoagulation (OAC, n = 26), defined as having an International normalized ratio >2.0 or having continued a direct oral anticoagulant, and those not anticoagulated (Off-OAC, n = 144). We evaluated for a composite outcome of all major complications, including access site complications and pericardial effusion. RESULTS OAC and Off-OAC groups had similar mean age (74 ± 13 vs 75 ± 13 years; P = .914). The OAC group had a nonsignificantly lower prevalence of end-stage renal disease (8% vs 17%; P = .375) and aspirin use (27% vs 47%; P = .131). Those in the OAC group were more likely to be on warfarin than those in the Off-OAC group (81% vs 30%; P < .001). The rate of the composite endpoint was similar between the OAC and Off-OAC groups (3.8 % vs 1.4%, respectively; P = .761). Length of stay was similar between groups (1.3 ± 2.6 vs 2.3 ± 3.4 days; P = 0.108). CONCLUSION Continuation of therapeutic anticoagulation during MICRA implantation appears to be feasible, safe and associated with shorter hospitalization among appropriately selected individuals.

  • outcomes of micra Leadless Pacemaker implantation with uninterrupted anticoagulation
    Journal of the American College of Cardiology, 2019
    Co-Authors: Soroosh Kiani, George B Black, Nancy Thakkar, Christopher Massad, Patel V Akshar, Faisal M Merchant, Michael H Hoskins, David B Delurgio, Anshul M Patel, Anand D Shah
    Abstract:

    Implantation of the MICRA Leadless Pacemaker requires use of a large (27 French) introducer, a large radius blunt delivery system and device fixation to the myocardium via nitinol tines. While prior studies have proven the safety of this procedure, it is unclear whether performing this procedure

Arthur A M Wilde - One of the best experts on this subject based on the ideXlab platform.

  • impact of Leadless Pacemaker therapy on cardiac and atrioventricular valve function through 12 months of follow up
    Circulation-arrhythmia and Electrophysiology, 2019
    Co-Authors: Niek E.g. Beurskens, Fleur V Y Tjong, Arthur A M Wilde, Kosse J Dasselaar, Wichert J Kuijt, Rianne H A C M De Bruinbon, Reinoud E Knops
    Abstract:

    BACKGROUND: Endocardial Pacemaker leads and right ventricular (RV) pacing are well-known causes of tricuspid valve, mitral valve, and cardiac dysfunction. Lead-related adverse consequences can potentially be mitigated by Leadless Pacemaker (LP) therapy by eliminating the presence of a transvalvular lead. This study assessed the impact of LP placement on cardiac and valvular structure and function. METHODS: Echocardiographic studies before and 12±1 months after LP implantation were performed between January 2013 and May 2018 at our center and compared with age- and sex-matched controls of dual-chamber transvenous Pacemaker recipients. RESULTS: A total of 53 patients receiving an LP were included, of whom 28 were implanted with a Nanostim and 25 with a Micra LP device. Tricuspid valve regurgitation was graded as being more severe in 23 (43%) patients at 12±1 months compared with baseline ( P<0.001). Compared with an apical position, an RV septal position of the LP was associated with increased tricuspid valve incompetence (odds ratio, 5.20; P=0.03). An increase in mitral valve regurgitation was observed in 38% of patients ( P=0.006). LP implantation resulted in a reduction of RV function, according to a lower tricuspid annular plane systolic excursion ( P=0.003) and RV tricuspid lateral annular systolic velocity ( P=0.02), and a higher RV Tei index ( P=0.04). LP implantation was further associated with a reduction of left ventricular ejection fraction ( P=0.03) and elevated left ventricular Tei index ( P=0.003). The changes in tricuspid valve regurgitation in the LP group were similar to the changes in the dual-chamber transvenous Pacemaker control group (43% versus 38%, respectively; P=0.39). CONCLUSIONS: LP therapy is associated with an increase in tricuspid valve dysfunction through 12 months of follow-up; yet it was comparable to dual-chamber transvenous Pacemaker systems. Furthermore, LP therapy seems to adversely impact mitral valve and biventricular function.

  • Leadless Pacemaker implantation after explantation of infected conventional Pacemaker systems a viable solution
    Heart Rhythm, 2019
    Co-Authors: Niek E.g. Beurskens, Fleur V Y Tjong, Arthur A M Wilde, Kosse J Dasselaar, Wichert J Kuijt, Reinoud E Knops
    Abstract:

    Background Conventional cardiac device infections are increasing in incidence, causing significant morbidity and mortality. Leadless Pacemaker (LP) therapy may provide new opportunities for the management of Pacemaker (PM) infections as it does not require implantation of transvenous leads and a pectoral pocket. Objective We sought to evaluate the effect of early and late LP implantation in patients diagnosed with device infection. Methods Patients receiving an LP at our center after conventional PM lead extraction due to infection between December 1, 2013 and November 30, 2017 were included. Results A total of 17 patients (mean age 77.4 ± 7.77 years) underwent LP implantation (ie, 11 with Nanostim Leadless cardiac Pacemaker [Abbott, Chicago, IL] and 6 with Micra transcatheter pacing system [Medtronic, Minneapolis, MN]) after successful PM system explantation. In 9 PM-dependent patients, a temporary transvenous pacing system was placed as a bridge to permanent LP implantation. Early LP implantation was performed in 6 patients ( 1 week). All patients experienced no LP infection during a mean follow-up of 16 ± 12 months, including 7 patients with a history of recurrent device infections with a mean follow-up of 20 ± 14 months. Conclusion Early and late LP placement after infected conventional pacing system explantation was a viable option in our case series. This therapy may provide an alternative strategy in the management of device infection, if confirmed by subsequent prospective randomized trials, particularly for patients who are PM dependent or have a history of recurrent device infections.

  • device orientation of a Leadless Pacemaker and subcutaneous implantable cardioverter defibrillator in canine and human subjects and the effect on intrabody communication
    Europace, 2018
    Co-Authors: Annefloor B E Quast, Fleur V Y Tjong, Reinoud E Knops, Arthur A M Wilde, Brendan E Koop, Martin C Burke
    Abstract:

    Aims: The development of communicating modular cardiac rhythm management systems relies on effective intrabody communication between a subcutaneous implantable cardioverter-defibrillator (S-ICD) and a Leadless Pacemaker (LP), using conducted communication. Communication success is affected by the LP and S-ICD orientation. This study is designed to evaluate the orientation of the LP and S-ICD in canine subjects and measure success and threshold of intrabody communication. To gain more human insights, we will explore device orientation in LP and S-ICD patients. Methods and results: Canine subjects implanted with a prototype S-ICD and LP (both Boston Scientific, MA, USA) with anterior-posterior fluoroscopy images were included in this analysis. For comparison, a retrospective analysis of human S-ICD and LP patients was performed. The angle of the long axis of the LP towards the vertical axis of 0°, and distance between the coil and LP were measured. Twenty-three canine subjects were analysed. Median angle of the LP was 29° and median distance of the S-ICD coil to LP was 0.8 cm. All canine subjects had successful communication. The median communicating threshold was 2.5 V. In the human retrospective analysis, 72 LP patients and 100 S-ICD patients were included. The mean angle of the LP was 56° and the median distance between the S-ICD coil and LP was 4.6 cm. Conclusion: Despite the less favourable LP orientation in canine subjects, all communication attempts were successful. In the human subjects, we observed a greater and in theory more favourable LP angle towards the communication vector. These data suggests suitability of human anatomy for conductive intrabody communication.

  • postmortem histopathological examination of a Leadless Pacemaker shows partial encapsulation after 19 months
    Circulation-arrhythmia and Electrophysiology, 2015
    Co-Authors: Fleur V Y Tjong, Olga C G Stam, L F M Beenen, Berto J Bouma, Joris R De Groot, Arthur A M Wilde, Reinoud E Knops
    Abstract:

    An 80-year-old male, with a history of coronary artery disease (coronary artery bypass graft surgery) and bradytachy syndrome was referred for a recurring Pacemaker pocket infection of his dual chamber Pacemaker system. The infected system was explanted and the leads extracted using laser, followed by antibiotic treatment. As the patient only required infrequent pacing, the choice for a single chamber pacing system was made. In January 2013, a Leadless Pacemaker (LP; Nanostim, St. Jude Medical, MN) was successfully implanted in the right ventricular (RV) apex. Four months postimplant, a transesophageal echocardiographic examination reconfirmed correct deployment of the LP in the RV apex, and the distal end of the LP moving freely during myocardial contraction (Figure 1A and 1B; Data Supplement), touching the lateral RV wall but not interfering with the RV septum (Movie in the Data Supplement). The LP did not interfere with the RV outflow tract, pulmonary valve or tricuspid valve, and no mobile structures were identified on the LP. The patient was monitored in the Pacemaker outpatient clinic …