[History of cardiac pacemaker therapy in Germany]. / Geschichte der Herzschrittmacher-Therapie in Deutschland.

Cardiac pacemaker therapy began with successful stimulation of human hearts already in the first half of the 20th century. Complete implantation of a pacemaker by the cardiac surgeon Åke Senning on October 8, 1958 at the Karolinska Hospital in Stockholm is considered the actual birth of today's pacemaker therapy. The first pacemaker implantation in Germany was performed by Hans-Joachim Sykosch on October 6, 1961 at the Surgical Clinic of the University of Düsseldorf. Two years later, the first implantation in East Germany (GDR) was carried out by Friedrich Flemming on September 2, 1963 at the Charité in East Berlin. The first pacemaker manufactured in West Germany arrived on the market 1963; East Germany started device production in 1978. In 1974, pacemaker therapy in West Germany showed a 50% survival rate after 6.3 years compared to < 1 year with drug therapy. After initially using bare metal wires, pacemaker leads have significantly improved in both quality and reliability. Development culminated in the leadless pacemaker. Battery development led to a variety of inventions: rechargeable pacemakers, biogalvanic cells, bioenergy sources, nuclear generators and lithium batteries, the latter ultimately prevailed. In the beginning, only fixed-rate ventricular pacemakers were available. Subsequently, systems adapted to physiological requirements were developed: on-demand pacemakers, atrial-based pacing and rate-adaptive systems. However, it was not until the return to direct stimulation of the conduction system that truly physiological stimulation of the heart became possible.

Cephalic Vein Cutdown Is Superior to Subclavian Puncture as Venous Access for Patients with Cardiac Implantable Devices after Long-Term Follow-Up.

BACKGROUND: Cephalic vein cutdown (CVC) and subclavian vein puncture (SVP) are the most commonly used access sites for transvenous lead placement of cardiac implantable electronic devices (CIEDs). Limited knowledge exists about the long-term patency of the vascular lumen housing the leads. METHODS: Among the 2703 patients who underwent CIED procedures between 2005 and 2013, we evaluated the phlebographies of 162 patients scheduled for an elective CIED replacement (median of 6.4 years after the first operation). The phlebographies were divided into four stenosis types: Type I = 0%, Type II = 1-69%, Type III = 70-99%, and Type IV = occlusion. Due to the fact that no standardized stenosis categorization exists, experienced physicians in consensus with the involved team made the applied distribution. The primary endpoint was the occurrence of stenosis Type III or IV in the CVC group and in the SVP group. RESULTS: In total, 162 patients with venography were enrolled in this study. The prevalence of high-degree stenosis was significantly lower in the CVC group (7/89, 7.8%) than in the SVP group (15/73, 20.5%, p = 0.023). In the CVC group, venographies showed a lower median stenosis (33%) than in the SVP group (median 42%). CONCLUSIONS: The present study showed that the long-term patency of the subclavian vein is higher after CVC than after SVP for venous access in patients with CIED.

[Asymptomatic bradycardia and pacemaker : To implant, or not to implant?] / Asymptomatische Bradykardien : Wann ist die Implantation eines Herzschrittmachers sinnvoll?

The cardiac implantable electronic device (CIED) is the therapy of choice for management of symptomatic bradyarrhythmias. However, the indication for CIED implantation in the cases of asymptomatic bradycardias should be carefully individualized. Incidental electrocardiographic findings in asymptomatic patients (e.g., low baseline heart rates, higher than first-degree atrioventricular block or longer pauses) may complicate the physician's decision regarding the necessity of CIED implantation. The main reason is the inherit risk of short- and long-term complications with every CIED implantation, i.e., peri-operative complications, risk of CIED infection, lead fractures, and the necessity for lead extraction. Therefore, before opting for, or against, CIED implantation, several factors should be considered in the subset of asymptomatic patients.

Perioperative complications after pacemaker implantation: higher complication rates with subclavian vein puncture than with cephalic vein cutdown.

PURPOSE: The cephalic vein cutdown (CVC) and the subclavian puncture (SP) is the most common access for pacemaker implantation. The purpose of this study was to compare the peri-/postoperative complications of these approaches. METHODS: A retrospective analysis of the quality assurance data of the state of North Rhine-Westphalia was performed to evaluate the peri-/postoperative complications of first pacemaker implantation according to the venous access. The primary endpoint was defined as the occurrence of one of the following: asystole, ventricular fibrillation, pneumothorax, hemothorax, pericardial effusion, pocket hematoma, lead dislocation, lead dysfunction, postoperative wound infection or other complication requiring intervention. Descriptive analysis was done via absolute, relative frequencies and Odds Ratio. Fisher's exact test was used for comparison of the both study groups. RESULTS: From 139,176 pacemaker implantations from 2010 to 2014, 15,483 cases were excluded due to other/double access. The median age was 78 years and the access used was CVC for 75,251 cases (60.8%) and SP for 48,442 cases (39.2%). The implanted devices were mainly dual-chamber pacemakers (73.9% in the CVC group and 78.4% in the SP group), followed by single-chamber pacemakers VVI (24.9% and 19.9% in the CVC and SP group respectively). There were significantly fewer peri/postoperative complications in the CVC group compared to the SP group (2.49% vs. 3.64%, p = 0.0001, OR 1.47; 95% CI 1.38-1.57). CONCLUSIONS: CVC as venous access for pacemaker implantation has significantly fewer peri/postoperative complications than SP and appears to be an advantageous technique.

Long-term prognosis of successful left ventricular substrate modification of electrical storm.

Introduction: The Electrical storm (ES) subsumes a state of electrical instability of the heart, which manifests itself in repeated and potentially fatal ventricular arrhythmias (VA). We examine the long-term effects of substrate modification with regards to mortality, ventricular tachycardia (VT) recurrences and hospitalization depending on age, gender, heart function, scare location, VT documentation, postprocedural electrical stimulation (PES) and induced VTs. Methods: From 08/2008 and 09/2019 160 consecutive patients admitted for ES ablation via electroanatomical mapping were followed up until 04/2021. Results: 50/160 patients showed VT recurrences after 13.8 ± 21.7 (0.0-80.3) months, with a characteristic steep curve directly after ES and then a rapid decline leading to a plateau (first month 10/50 (20%), first year 35/50 VT recurrences (70%) Mortality rates followed a similar pattern also the initial decline was not as steep. 42 patients died during the observation period (26%) after 16.6 ± 16.1 (0.0-67.9) months after ablation day (first month (n = 7, 16.7%) first year (n = 21, 50%). Gender, age, scare localization, missing VT documentation did not worsen outcome. Induction of >3 VTs and lack of PES due to hemodynamic instability significantly decreased effectiveness. Finding the entry significantly increased long-term effects. Conclusion: Ablation of ES is safe and feasible independent of a variety of factors. Employing more sophisticated tools to understand the reentry mechanism will further improve the long-term outcome.

Improvement of electrical synchrony in cardiac resynchronization therapy using dynamic atrioventricular delay programming and multipoint pacing.

BACKGROUND: Optimization of cardiac resynchronization therapy (CRT) is often time-consuming and therefore underused in a clinical setting. Novel device-based algorithms aiming to simplify optimization include a dynamic atrioventricular delay (AVD) algorithm (SyncAV, Abbott) and multipoint pacing (MPP, Abbott). This study examines the acute effect of SyncAV and MPP on electrical synchrony in patients with newly and chronically implanted CRT devices. METHODS: Patients with SyncAV and MPP enabled devices were prospectively enrolled during implant or scheduled follow-up. Blinded 12-lead electrocardiographic acute measurements of QRS duration (QRSd) were performed for intrinsic QRSd (Intrinsic), bi-ventricular pacing (BiV), MPP, BiV with SyncAV at default offset 50 ms (BiVSyncAVdef ), BiV with SyncAV at patient-specific optimised offset (BiVSyncAVopt ), MPP with SyncAV at default offset 50 ms (MPPSyncAVdef ), and MPP with SyncAV at patient-specific optimised offset (MPPSyncAVopt ). RESULTS: Thirty-three patients were enrolled. QRSd for Intrinsic, BiV, MPP, BiVSyncAVdef , BiVSyncAVopt , MPPSyncAVdef , MPPSyncAVopt were 160.4 ± 20.6 ms, 141.0 ± 20.5 ms, 130.2 ± 17.2 ms, 121.7 ± 20.9 ms, 117.0 ± 19.0 ms, 121.2 ± 17.1 ms, 108.7 ± 16.5 ms respectively. MPPSyncAVopt led to greatest reduction of QRSd relative to Intrinsic (-31.6 ± 11.1%; p < .001), showed significantly shorter QRSd compared to all other pacing configurations (p < .001) and shortest QRSd in every patient. Shortening of QRSd was not significantly different between newly and chronically implanted devices (-51.6 ± 14.7 ms vs. -52.7 ± 21.9 ms; p = .99). CONCLUSION: SyncAV and MPP improved acute electrical synchrony in CRT. Combining both technologies with patient-specific optimization resulted in greatest improvement, regardless of time since implantation. Whats new Novel device-based algorithms like a dynamic AVD algorithm (SyncAV, Abbott) and multipoint pacing (MPP, Abbott) aim to simplify CRT optimization. Our data show that a combination of patient tailored SyncAV optimization and MPP results in greatest improvement of electrical synchrony in CRT measured by QRS duration, regardless if programmed in newly or chronically implanted devices. This is the first study to our knowledge to examine a combination of these device-based algorithms. The results help understanding the ideal ventricular excitation in heart failure.

[Perioprocedural mortality after ICD implantation]. / Peripoperative Mortalität nach ICD-Implantation.

BACKGROUND: Implantable cardioverter defibrillators (ICD) represent an established treatment in preventing sudden cardiac death in patients with indications for primary or secondary prophylaxis. As for all complex surgical procedures there remains a risk for the occurrence of complications including death also for ICD implantation. The aim of the present study was to analyze the procedure-related mortality in patients after ICD implantation using the data from the obligatory quality assurance program in North-Rhine/Westphalia. METHODS: Data of all 18,625 patients from the quality assurance datasets who underwent ICD implantation in the years 2010-2012 were analyzed. RESULTS: During the in-hospital stay 118 patients (0.6%) died after ICD implantation. Patients > 80 years old had a higher mortality (1.9% vs. 0.5% in patients < 80 years old, p < 0.001) as well as women (0.95% vs. 0.54% in men, p = 0.004) and patients with higher New York Heart Association (NYHA) class (0.3% for NYHA II, 0.7% for NYHA III, 3.4% for NYHA IV, p < 0.001 for all comparisons). The presence of diabetes mellitus (23% of the collective) did not influence the perioperative mortality, whereas renal failure requiring dialysis showed a significantly increased mortality (p < 0.001 compared to patients with creatinine ≤ 1.5 mg/dl and p = 0.002 for patients with creatinine > 1.5 mg/dl not requiring dialysis). Patients with indications for ICD secondary prophylaxis had a significantly higher mortality (1.2% vs. 0.4%, p < 0.001), which increased from 0.6% to 3.7% (p < 0.001) with the occurrence of complications. CONCLUSION: The procedure-related mortality after ICD implantation is increased in patients over 80 years of age, higher NYHA class, patients requiring dialysis, in secondary prevention indications and after the occurrence of perioperative complications.

Transseptal use of high-density grid catheter for VT mapping and retrograde hemodynamic support with Impella pump in presence of Mitraclips.

PURPOSE: We sought to establish the technical feasibility of VT-mapping with high-density catheters in patients with Mitraclips, requiring a hemodynamic support. METHODS: A 73-year-old man with ischemic cardiomyopathy and reduced left ventricular ejection fraction (LVEF ~ 20%) was presented due to syncope and adequate shock of his ICD. Due to severe mitral valve regurgitation (MR), two Mitraclips were implanted earlier. The decision for catheter ablation was made in line with current guidelines. Given the increased PAAINESD score, the use of hemodynamic support was required. To employ an Impella pump via the retrograde transaortic approach, LV-mapping and VT-ablation were necessary to be performed via the transseptal approach, which was challenging due to the presence of Mitraclips. The MV passage with the steerable sheath was guided by a quadripolar catheter and 3D transoesophageal echo (TEE). After the 12F steerable sheath had passed the MV, the quadripolar catheter was exchanged by a high-density (HD) Grid® catheter. Hereafter, the Impella pump was placed retrogradely in the LV, and voltage-mapping of the LV and ablation was performed. RESULTS: At the end of the procedure, the Impella pump could be removed in stable hemodynamic conditions. The follow-up after 3, 6, and 12 months showed no new VT episodes. CONCLUSIONS: This case demonstrates the feasibility of the transseptal approach of VT mapping used HD Grid catheter and retrograde hemodynamic support with Impella Pump for VT treatment in patients after Mitraclips implantation. To avoid a damage of the MV and Mitraclips, 3D-TEE is advisable.

[Electrical storm : Recognition and management]. / Elektrischer Sturm : Erkennung und Beherrschung.

The electrical storm (ES) defined as ≥3 sustained episodes of ventricular tachycardia within a 24 h period comprises a wide spectrum of clinical entities. Mostly patients suffer from severe heart insufficiency and comorbidities making an immediate transfer into a heart center with multidisciplinary expertise in the treatment of ES mandatory. As these patients are often traumatized by ongoing tachycardia despite multiple cardioversions, early deep sedation and ß­blockade to break the vicious circle of sympathico-adrenergic hyperactivation is very effective. Multiple ICD discharges suggesting the diagnosis of ES are inadequate in one third of cases. Pharmacological suppression, frequency control or ablation of supraventricular tachycardias (SVT) help in most cases. In some cases "oversensing" demands optimization of ICD programming. Even so not all adequate ICD discharges, however, are necessary. Since every ICD discharge worsens the patient's prognosis, any kind of ICD discharge should be prevented as far as hemodynamically feasible. After clinical stabilization of the patient with simultaneous acquisition of ECG and testing for reversible causes of ES, ES should be terminated by external or internal cardioversion followed by urgent but elective therapy. Some cases of ES, however, may require immediate escalation of therapy with emergency ablation or revascularization sometimes with circulatory support systems. If ES still persists, a further step in escalation may be taken by cardiac sympathetic denervation. Due to the poor prognosis of patients after ES, close monitoring of the patient, preferably with telemedicine, is indicated.

Single chamber implantable cardioverter defibrillator compared to dual chamber implantable cardioverter defibrillator: less is more! Data from the German Device Registry.

BACKGROUND: In patients with high risk for sudden cardiac death the implantation of a defibrillator is an established treatment. However the benefits and risks for patients in accordance to the number of the leads are not clear. Even in the current guidelines a recommendation to this question is missing. We analyzed advantage and disadvantages of single-chamber implantable cardioverter defibrillators (VVI-ICD) versus dual-chamber implantable cardioverter defibrillators (DDD-ICD) in the prospective German Device Registry. METHODS: The data of 2240 patients who underwent ICD implantation in 45 German Centers between January 2007 and March 2011 were included in a prospective device registry (VVI: n = 1629, male = 1358, EF = 34% ± 13%; DDD: n = 611, male = 491, EF = 35% ± 14%). RESULTS: The in-hospital complications were significantly higher in the DDD-ICD group with higher revision/device complication rates (3.0% vs. 1.2%; p = 0.003) but also higher mortality rate (1.0% vs. 0.1%; p < 0.001). Regarding the adjusted data at 1-year follow-up DDD-ICD caused more device revisions, but no difference in rehospitalization and mortality. CONCLUSION: It is still unclear whether DDD-ICD may be beneficial for patients with preserved sinus and atrioventricular nodal function. Our data show that the decision of the operator to choose a DDD-ICD in these patients must be taken very carefully. By choosing a DDD-ICD the patient is exposed to a significantly higher periprocedural complication rate and higher in-hospital mortality. In absence of relevant bradycardias implantation of a DDD-ICD is not justified.

[Fitness to drive in patients with cardiovascular implantable electronic devices]. / Fahreignung bei implantierten kardiovaskulären elektrischen Geräten.

The term CIED (cardiovascular implantable electronic devices) merges two groups of devices: pacemakers (PM) and defibrillators (ICD). PMs improve the symptoms of patients with bradycardic disorders, while ICDs reduce mortality in patients with increased risk for sudden cardiac death. However, these patients are still at risk of suffering malignant arrhythmias. Even after implantation of a pacemaker, syncope may occur. If these arrhythmias arise while driving, other individuals could be endangered. Therefore, it is important and obligatory for the treating physician to clarify this issue regarding driving restrictions to all patients, who present an indication for device treatment. The present publication focuses on the principal points of present guidelines and recommendations regarding fitness to drive in patients with cardiac disorders (especially with CIED).