[Sixty-five years of pacemaker therapy]. / 65 Jahre Herzschrittmachertherapie.

Sixty-five years ago, the first pacemakers were implanted. Swedish developments paved the way for implantation of the first epicardial pacemaker with a rechargeable battery unit; however, there was a battery defect within 3 h. Further developments in the USA allowed for the first transvenous, endocardial lead to be implanted with an external pacemaker battery. Following these pioneering implantations, further improvements of the battery and electrical elements and also of lead technology (flexibility and fixation mechanism) allowed the implantation of pacemaker systems similar to those we still implant today.

Transcatheter Leadless Pacing in Children: A PACES Collaborative Study in the Real-World Setting.

BACKGROUND: Transcatheter Leadless Pacemakers (TLP) are a safe and effective option for adults with pacing indications. These devices may be an alternative in pediatric patients and patients with congenital heart disease for whom repeated sternotomies, thoracotomies, or transvenous systems are unfavorable. However, exemption of children from clinical trials has created uncertainty over the indications, efficacy, and safety of TLP in the pediatric population. The objectives of this study are to evaluate clinical indications, procedural characteristics, electrical performance, and outcomes of TLP implantation in children. METHODS: Retrospective data were collected from patients enrolled in the Pediatric and Congenital Electrophysiology Society TLP registry involving 15 centers. Patients ≤21 years of age who underwent Micra (Medtronic Inc, Minneapolis, MN) TLP implantation and had follow-up of ≥1 week were included in the study. RESULTS: The device was successfully implanted in 62 of 63 registry patients (98%) at a mean age of 15±4.1 years and included 20 (32%) patients with congenital heart disease. The mean body weight at TLP implantation was 55±19 kg and included 8 patients ≤8 years of age and ≤30 kg in weight. TLP was implanted by femoral (n=55, 87%) and internal jugular (n=8, 12.6%) venous approaches. During a mean follow-up period of 9.5±5.3 months, there were 10 (16%) complications including one cardiac perforation/pericardial effusion, one nonocclusive femoral venous thrombus, and one retrieval and replacement of TLP due to high thresholds. There were no deaths, TLP infections, or device embolizations. Electrical parameters, including capture thresholds, R wave sensing, and pacing impedances, remained stable. CONCLUSIONS: Initial results from the Pediatric and Congenital Electrophysiology Society TLP registry demonstrated a high level of successful Micra device implants via femoral and internal venous jugular approaches with stable electrical parameters and infrequent major complications. Long-term prospective data are needed to confirm the reproducibility of these initial findings.

Safety of magnetic resonance imaging in patients with surgically implanted permanent epicardial leads.

BACKGROUND: Magnetic resonance imaging (MRI) safety in patients with an epicardial cardiac implantable electronic device (CIED) is uncertain. OBJECTIVE: The purpose of this study was to assess the safety and adverse effects of MRI in patients who had surgically implanted epicardial CIED. METHODS: Patients with surgically implanted CIEDs who underwent MRI with an appropriate cardiology-radiology collaborative protocol between January 2008 and January 2021 were prospectively studied in 2 clinical centers. All patients underwent close cardiac monitoring through MRI procedures. Outcomes were compared between the epicardial CIED group and the matched non-MRI-conditional transvenous CIED group. RESULTS: Twenty-nine consecutive patients with epicardial CIED (41.4% male; mean age 43 years) underwent 52 MRIs in 57 anatomic regions. Sixteen patients had a pacemaker, 9 had a cardiac defibrillator or cardiac resynchronization therapy-defibrillator, and 4 had no device generator. No significant adverse events occurred in the epicardial or transvenous CIED groups. Battery life, pacing, sensing thresholds, lead impedance, and cardiac biomarkers were not significantly changed, except 1 patient had a transient decrease in atrial lead sensing function. CONCLUSION: MRI of CIEDs with epicardially implanted leads does not represent a greater risk than transvenous CIEDs when performed with a multidisciplinary collaborative protocol centered on patient safety.

Leadless Pacemakers: State of the Art and Selection of the Ideal Candidate.

The field of cardiac pacing has been defined by constant development to provide efficacious, safe, and reliable therapy. Traditional pacing utilizes transvenous leads, which dwell in the venous system and place patients at risk for complications, including pneumothorax, bleeding, infection, vascular obstruction, and valvular compromise. Leadless pacemakers have been developed to overcome many of the challenges of transvenous pacing while providing safe and effective pacing therapy for an increasing population of patients. The Medtronic Micra transcatheter pacing system was approved by the FDA in April of 2016 and the Abbott Aveir pacemaker was approved in April of 2022. Several additional leadless pacemakers are in various stages of development and testing. There exists limited guidance on the selection of the ideal candidate for leadless pacemakers. Advantages of leadless pacemakers include decreased infection risk, overcoming limited vascular access, and avoidance of interaction with the tricuspid valve apparatus. Disadvantages of leadless pacemakers include right ventricular-only pacing, unclear lifecycle management, cost, perforation risk, and lack of integration with defibrillator systems. This review aims to provide an overview of the current state of the art of leadless pacemakers, currently approved systems, clinical trials and real-world evidence, considerations for patient selection, and future directions of this promising technology.

Upper Extremity Deep Vein Thrombosis and Asymptomatic Vein Occlusion in Patients With Transvenous Leads: A Systematic Review and Meta-Analysis.

Aims: The presence of transvenous leads for cardiac device therapy may increase the risk of venous thromboembolisms. The epidemiology of these complications has not yet been determined systematically. Therefore, this study aims to determine (I) the incidence of symptomatic upper extremity deep vein thrombosis (UEDVT) and (II) the prevalence of asymptomatic upper extremity vein occlusion in patients with transvenous leads, both after the initial 2 months following lead implantation. Methods: PubMed, EMBASE, and Cochrane Library were searched until March 31, 2020 to identify studies reporting incidence of UEDVT and prevalence of asymptomatic vein occlusion after the initial 2 months after implantation in adult patients with transvenous leads. Incidence per 100 patient years of follow-up (PY) and proportions (%) were calculated to derive pooled estimates of incidence and prevalence. Results: Search and selection yielded 20 and 24 studies reporting on UEDVT and asymptomatic vein occlusion, respectively. The overall pooled incidence of UEDVT was 0.9 (95% CI 0.5-1.4) per 100PY after 2 months after lead implantation. High statistical heterogeneity was present among studies (I2 = 82.4%; P = < 0.001) and only three studies considered to be at low risk of bias. The overall pooled prevalence of asymptomatic upper extremity vein occlusion was 8.6% (95% CI 6.0-11.5) with high heterogeneity (I2 = 81.4%; P = <0.001). Meta-regression analysis showed more leads to be associated with a higher risk of UEDVT. Conclusion: Transvenous leads are an important risk factor for symptomatic UEDVT, which may occur up to multiple years after initial lead implantation. Existing data on UEDVT after lead implantation is mostly of poor quality, which emphasizes the need for high quality prospective research. Asymptomatic vein occlusion is present in a substantial proportion of patients and may complicate any future lead addition. Clinical Trial Registration: (URL: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020178136, Identifier: PROSPERO 2020 CRD42020178136).

The role of transesophageal echocardiography in predicting technical problems and complications of transvenous lead extractions procedures.

BACKGROUND: Transesophageal echocardiography (TEE) is a useful tool in preoperative evaluation of patients undergoing transvenous lead extraction (TLE). HYPOTHESIS: Echocardiographic phenomena may determine the difficulty and safety of the procedure. METHODS: Data from 936 transesophageal examinations (TEE) performed at a high volume center in patients awaiting TLE from 2015 to 2019 were assessed. RESULTS: TEE revealed a total of 1156 phenomena associated with the implanted leads in 697 (64.85%) patients, including: asymptomatic masses on endocardial leads (AMEL) (58.65%), vegetations (12,73%), fibrous tissue binding the lead to the vein or heart wall (33.76%), lead-to-lead binding sites (18.38%), excess lead loops (19.34%), intramural penetration of the lead tip (16.13%) and lead-dependent tricuspid dysfunction (LDTD) (6.41%). Risk factors for technical difficulties during TLE in multivariate analysis were: fibrous tissue binding the lead to atrial wall (OR = 1.738; p < 0.05), to right ventricular wall (OR = 2.167; p < 0.001), lead-to-lead binding sites (OR = 1.628; p < 0.01) and excess lead loops (OR = 1.488; p < 0.05). Lead-to-lead binding sites increased probability of major complications (OR = 3.034; p < 0.05). Presence of fibrous tissue binding the lead to the superior vena cava (OR = 0.296; p < 0.05), right atrial wall (OR = 323; p < 0.05) and right ventricular wall (OR = 0.297; p < 0.05) reduced the probability of complete procedural success, whereas fibrous tissue binding the lead to the tricuspid apparatus decreased the probability of clinical success (OR = 0.307; p < 0.05). CONCLUSIONS: Careful preoperative TEE evaluation of the consequences of extended lead implant duration (enhanced fibrotic response) increases the probability of predicting the level of difficulty of TLE procedures, their efficacy and risk of major complications.

Long-term incidence of upper extremity venous obstruction in implantable cardioverter defibrillator patients.

BACKGROUND: Very little is known about the long-term prevalence of severe venous obstruction and occlusion in patients with transvenous implantable cardioverter-defibrillator leads. The objective of the current investigation was to elucidate the incidence and prevalence and to identify predisposing conditions in an ICD cohort over a long follow-up period. METHODS: Based on a prospective database, we analyzed consecutive patients who received an ICD implantation in our hospital between 06/1988 and 2009 as well as all corresponding follow-up data until 02/2018. Cavographies were used for analysis, and all patients with at least one device replacement and one follow-up cavography were included. RESULTS: Over a mean follow-up period of 94 ± 50 months, severe venous obstruction was found in 147 (33%) of 448 patients. Kaplan-Meier analysis shows a severe obstruction or occlusion in 50% of patients after a period of 14.3 years. The total number of leads (p < .001, HR 2.01, CI 2.000-2.022), an advanced age (p = .004, HR 1.023 per year, CI 1.022-1.024) and the presence of dilated cardiomyopathy (p = .035, HR 1.49, CI 1.47-1.51) were predictive of venous obstruction whereas the presence of anticoagulation was not. CONCLUSION: Severe obstruction of the access veins after ICD implantation occurs frequently and its prevalence shows a nearly linear increase over long-time follow-up. Multiple leads, an advanced age and DCM as underlying disease are associated with an increased risk of venous obstruction while the role of anticoagulation to prevent venous obstruction in ICD patients is unclear.

Fibroplasty (venoplasty) to facilitate transvenous lead placement: A single-center experience.

INTRODUCTION: Venous stenosis is a well-recognized complication of transvenous leads (TVLs) that is encountered during lead revisions or device upgrades. We here report the outcomes of TVL placement facilitated by fibroplasty or tunneling (TUN) procedure. METHODS: We conducted a single-center retrospective cohort study of all patients undergoing TVL implantation requiring fibroplasty or TUN from 2005 to 2017. Medical records and procedure reports were reviewed for relevant data. Outcomes for fibroplasty and TUN to facilitate TVL placement were compared. RESULTS: Sixty patients had fibroplasty and thirty-five patients had a TUN procedure. There was no difference in procedure success rates between the two groups (97% fibroplasty vs. 100% TUN; p = .98). The fluoroscopy time was longer (fibroplasty = 39.7 ± 21.5 min vs. TUN = 29.2 ± 21.3 min; p = .01) and the total procedural time was shorter in the fibroplasty group (fibroplasty = 247 ± 77.8 min vs. TUN = 287 ± 77.1 min; p = .01). TUN was associated with a significantly higher incidence of acute complications (fibroplasty = 0 vs. TUN = 8; p = .002) most requiring invasive intervention and/or transfusion with blood products. Long-term complications requiring additional device-related procedures were comparable between the two groups (fibroplasty = 6 vs. TUN = 6; logrank p = .21). CONCLUSIONS: For patients with venous stenosis requiring additional TVL, balloon fibroplasty is associated with similar rates of success and a significantly decreased incidence of acute complications when compared with subcutaneous TUN.

Costs and complications associated with transvenous lead reoperation in cardiac implantable electronic devices.

BACKGROUND: Cardiac implantable electronic device transvenous (TV) lead reoperations are projected to increase, and robust economic data are needed to assess the resulting financial impact and the cost-effectiveness of prevention and treatment strategies. This study estimates Medicare costs, and describes patterns of complications, in patients who underwent TV lead reoperation. METHODS AND RESULTS: Medicare data (2010-2014) were used to identify patients who underwent TV lead reoperation. Cumulative costs to Medicare, and rates of infection and mechanical complications were calculated from 180 days before, to 180 days after, lead reoperation. Multivariate analysis was used to estimate adjusted costs, and to examine the impact of complications on medical resource use and costs. There were 1691 patients, 63.2% of whom underwent inpatient lead reoperation. Overall, the mean age was 78.2 years, 39.6% were female, and 92.3% were white. The mean cumulative cost was $36 199 (95% confidence interval [CI], $31 864-$40 535) for TV lead repositioning, $27 701 (95% CI, $19 869-$35 534) for repair, and $54 442 (95% CI, $51 651-$57 233) for removal. Underlying infection was associated with increased odds of inpatient reoperation and of lead removal, as well as longer length of stay and higher costs. CONCLUSIONS: The economic consequences of TV lead reoperation are substantial. Strategies aimed at reducing reoperation, particularly lead removal, are likely to result in considerable cost offsets.

Five-year follow-up of transvenous and epicardial left ventricular leads: experience with more than 1000 leads.

OBJECTIVES: Transvenous coronary sinus leads are considered to be the gold standard for cardiac resynchronization therapy (CRT). However, in patients with abnormal coronary vein anatomy, the epicardial leads can be an alternative. Data comparing durability and performance of these 2 lead types are limited. In order to provide clarity, we investigated patients receiving CRT system in our centre. METHODS: One thousand and fifty-three consecutive patients scheduled for CRT implantation were retrospectively analysed. From these, 895 received transvenous coronary sinus and 158 epicardial left ventricular (LV) leads. Lead-specific as well as LV functional parameters have been evaluated in 60 months' follow-up. RESULTS: Technical characteristics (pacing threshold, impedance and sensing) of both lead types remained stable during the whole observation period. Whereas an early revision (<6 month) was noted in 5.4% of transvenous leads, no reintervention has been necessary for epicardial leads. During the 5-year observation period, a lead revisions rate of 10.2% for transvenous leads and 1.9% for epicardial leads were detected. Regarding CRT efficacy, excellent results were achieved for both electrode types. In both groups, a statistically significant reduction of New York Heart Association class (2.85-2.13 and 2.96-2.09), increase in left ventricular ejection fraction (24.6-32.6% and 27.2-34.6%), reduction of left ventricular end-systolic diameter/left ventricular end-diastolic diameter and reduction in degree of mitral valve insufficiency could be observed over the time. CONCLUSIONS: Our data demonstrate safety and functional efficacy of both transvenous and epicardial leads. Moreover, in long-term follow-up, a commendable durability and performance were found for both lead types. Thus, epicardial leads represent a good alternative when transvenous implantation fails.

Candidacy for a Subcutaneous Implantable Cardioverter Defibrillator in Patients with Cardiac Resynchronization Therapy.

In patients requiring an implantable cardioverter defibrillator (ICD), the combined use of a prior pacemaker and a subcutaneous ICD (S-ICD) could be an alternative treatment option to implantation of new leads or upgrading of pacemakers to an ICD if vascular access is limited. Here, we assessed the prevalence of S-ICD's eligibility according to surface electrogram screening in those receiving cardiac resynchronization therapy (CRT). S-ICD's eligibility was assessed in patients with a CRT pacemaker or a CRT defibrillator using the S-ICD template screening tool. Eligibility was defined as fulfillment of the template in both supine and upright positions in one or more leads during biventricular pacing. Among 44 patients (34 men, age: 67 ± 12), 36 (82%) were found to be eligible. The T/QRS amplitude ratio in lead II was significantly lower in those who were eligible (0.31 ± 0.16 versus 0.44 ± 0.18 in the ineligible group, P = 0.04). The lead position, underlying disease, and other electrocardiographic findings were not different between those who were eligible and those who were not. The majority of patients with biventricular pacing were eligible for S-ICD based on current screening tests and may benefit from this treatment. Further study is required.

Longitudinal Outcomes of Epicardial and Endocardial Pacemaker Leads in the Adult Fontan Patient.

Placement of an epicardial pacemaker system is often preferred over an endocardial system in patients who have undergone a Fontan operation, but data are limited on how these two systems perform over time in patients with Fontan palliation. We performed a retrospective review of adults with Fontan palliation who had pacemaker implantation and interrogation data at Mayo Clinic from 1994 to 2014. Lead parameters, pacing mode, and polarity were collected at the earliest device interrogation report. Clinic notes and device interrogation reports were reviewed at implantation, 6 months, and yearly after implantation to determine impedance, capture threshold (CT), and energy threshold (ET). There were 87 patients with 168 leads in the study cohort. The mean follow-up time was 7.7 years (6 months-19 years). There were 143 epicardial leads (57 atrial and 86 ventricular) and 25 endocardial leads (20 atrial and 5 ventricular). There was no difference in the baseline lead parameters between epicardial and endocardial leads for impedance (610 ± 259 versus 583 ± 156 Ω, p = 0.93), CT (2.0 ± 1.3 versus 1.8 ± 1.3 V, p = 0.28), or ET (7.1 ± 12.5 versus 6.8 ± 18.1 µJ, p = 0.29). Compared to endocardial leads, ventricular epicardial leads were associated with temporal decrease in impedance and increase in ET. Regarding clinical outcomes, epicardial leads had higher rates of failure but similar generator longevity in comparison to endocardial leads. Ventricular epicardial leads were associated with temporal decrease in impedance and increase in ET. Epicardial leads had a higher rate of failure but similar generator longevity compared to endocardial leads.

Safety, Efficacy and Evidence Base for Use of the Subcutaneous Implantable Cardioverter Defibrillator.

The trans-venous implantable cardioverter defibrillator (TV-ICD) is effective in treating life-threatening ventricular arrhythmia and reduces mortality in high-risk patients. However, there are significant short- and long-term complications that are associated with intravascular leads. These shortcomings are mostly relevant in young patients with long life expectancy and low risk of death from non-arrhythmic causes. Drawbacks of trans-venous leads recently led to the development of the entirely subcutaneous implantable cardioverter defibrillator (S-ICD). The S-ICD does not require vascular access or permanent intravascular defibrillation leads. Therefore, it is expected to overcome many complications associated with conventional ICDs. This review highlights data on safety and efficacy of the S-ICD and is envisioned to help in identifying the role of this device in clinical practice.

A retrospective review of 146 active and passive fixation bradycardia lead implantations in 74 dogs undergoing pacemaker implantation in a research setting of short term duration.

BACKGROUND: Canine veterinary patients increasingly benefit from implantation of transvenous pacemakers for bradyarrhythmias. No published data exist examining procedural outcomes of pacemaker implantation performed in the preclinical laboratory. The purpose was to review short term complication, infection, dislodgement, penetration rates, plus overall morbidity following pacemaker implantation in the research setting. A retrospective review of 74 Class A purpose-bred mongrels implanted with active (n = 89) and passive fixation (n = 57) intracardiac leads for dual (n = 72) or single (n = 2) chamber pacing was performed. RESULTS: All leads were implanted successfully, meeting electrical implant criteria. Follow-ups typically occurred every 7 days (first month), then at 30 day intervals. Seroma formation was 1.4% and 10.8% at the venotomy and pulse generator site respectively. Overall infection rate was 1.4%. Overall dislodgement rate was 2.1%, (2 passive atrial leads, 1 passive ventricular lead). Overall fractures and insulation defects were zero. Two helix penetrations were noted incidentally post mortem, one at the right atrial appendage and one at the right ventricle (64 dogs, 128 leads evaluated), a 1.6% event rate. Major in-life adverse events were 5.4% (4 of 74 dogs), including 1 infection and 3 lead dislodgements. CONCLUSIONS: This review demonstrates a low complication rate with bradycardia lead implants in the short term (up to 180 days), in a high volume research setting. Lead type, implant technique, surgeon experience, healthy patient population, patient size and follow-up care play a role. This review also suggests active fixation leads in the right atrial appendage of dogs are safe and reliable.

Leadless Pacemakers: State of the Art and Future Perspectives.

Leadless pacemaker therapy is a new technology that aims at avoiding lead- and pocket-related complications of conventional transvenous and epicardial pacing. To date, 2 self-contained leadless pacemakers for right ventricular pacing have been clinically available: the Nanostim Leadless Pacemaker System and the Micra Transcatheter Pacing System. Additionally, a new multicomponent leadless pacemaker for endocardial left ventricular pacing has been proposed as an alternative choice for cardiac resynchronization therapy. In this review, we describe the state of the art of leadless pacing and compare the currently available devices with traditional transvenous leadless pacemakers.

Long-term outcome of transvenous pacemaker implantation in infants: a retrospective cohort study.

AIM: Evaluation of long-term outcome of transvenous pacemaker (PM) implantation in infants. METHODS AND RESULTS: A retrospective analysis of all transvenous PM implantations in infants <10 kg between September 1997 and October 2001 was made. Indications for PM implantation, age at implantation, and determinants of long-term outcome including cardiac function, PM function, and PM (system) complications were noted. Seven patients underwent transvenous VVI(R) PM implantation. Median age at implantation was 3 days (range: 1 day to 14 months), median weight 3.5 kg (range: 2.3-8.7 kg), and median follow-up 14 years (range: 12.3-16.3 years). Pacemaker indications were congenital complete atrioventricular block (n = 4), long QT syndrome with heart block (n = 2), and post-operative complete atrioventricular block with sinus node dysfunction (n = 1). No procedural complications were noted. Today all patients are alive and symptom free with good PM and cardiac function. Two patients underwent PM generator relocation for imminent skin necrosis and skin traction. Two patients suffered from asymptomatic left subclavian vein occlusion and developed thrombosis on the PM electrode. Three patients were converted to an epicardial PM system, due to atrial perforation after upgrading procedure (n = 1), syncope with need for implantable cardioverter defibrillator implantation (n = 1), and systolic dysfunction with development of dilated cardiomyopathy, which normalized under cardiac resynchronization therapy pacing (n = 1). Two patients needed atrioventricular (AV) valve repair for severe insufficiency. Two patients underwent repositioning of dysfunctional PM leads. In five patients, transvenous leads were removed. Indications were elective lead replacement (n = 1), atrial perforation (n = 1), and switch to an epicardial system (n = 3). CONCLUSION: Transvenous PM implantation in infants (<10 kg) is associated with a high incidence of vascular occlusion, thrombosis, and severe atrioventricular valve regurgitation during long-term follow-up. We advocate an epicardial approach for PM implantation in small children.

Contralateral transvenous left ventricular lead placement of implantable devices with pre-sternal tunnelling in chronically obstructed subclavian veins.

Cardiac resynchronisation therapy (CRT) is a recognised therapy for the management of severe left ventricular dysfunction, advanced congestive cardiac failure (NYHA III or IV), ventricular dyssynchrony (either broad LBBB or mechanical dyssynchrony on echocardiography) and failure of optimal medical therapy to achieve improvement in clinical status. Upgrading right ventricular pacemakers or defibrillators to biventricular devices is common and we describe here, 2 such cases of biventricular upgrade with blocked venous access on the ipsilateral side and successful placement of left ventricular leads following pre-sternal tunnelling from the contralateral side.

The Entirely Subcutaneous Defibrillator - A New Generation and Future Expectations.

Although conventional implantable cardioverter-defibrillators (ICDs) have proved effective in the prevention of sudden cardiac death (SCD), they still appear to be limited by non-trivial acute and long-term complications. The recent advent of an entirely subcutaneous ICD (S-ICD) represents a further step in the evolution of defibrillation technology towards a less-invasive approach. This review highlights some historical and current issues concerning the S-ICD that may offer a viable therapeutic option in selected patients at high risk of SCD and in whom pacing is not required. After the CE Mark and US Food and Drug Administration (FDA) approvals, the S-ICD is being implanted worldwide with growing clinical data regarding its safety and efficacy (the EFFORTLESS Registry). The recently developed new generation of S-ICD (EMBLEM, Boston Scientific) demonstrates favourable features including a smaller device, longer longevity and remote-monitoring compatibility. Further innovations in the S-ICD system and potential integration with leadless pacing may play an important role in defibrillation therapy and prevention of SCD in the near future.