Biotronik

BACKGROUND: Conduction system pacing (CSP), either as His bundle pacing (HBP) or as left bundle branch area pacing (LBBAP), may be superior to right ventricular apical or septal pacing. OBJECTIVE: The study sought to present acute results for a new guiding catheter (Biotronik Selectra 3D) designed for CSP implantations of a retractable screw-in lead (Biotronik Solia S). METHODS: The primary endpoint of the prospective, international nonrandomized BIO|MASTER...

BACKGROUND AND AIMS: To predict worsening heart failure hospitalizations (WHFH) in patients with implantable defibrillators and remote monitoring (RM), the HeartInsight algorithm (Biotronik, Berlin, Germany) calculates a heart failure (HF) score combining seven physiologic parameters: 24-hour heart rate (HR), nocturnal HR, HR variability, atrial tachyarrhythmia, ventricular extrasystoles, patient activity, and thoracic impedance. We compared temporal trends of the HF score and its components 12 weeks before a WHFH with 12-week trends in patients without WHFH, to assess whether trends indicate deteriorating HF regardless of alert status...

BACKGROUND: Distal cervical internal carotid artery (cICA) pseudoaneurysms are uncommon. They may lead to thromboembolic or hemorrhagic complications, especially in young adults. We report one of the first cases in the literature regarding the management via PK Papyrus (Biotronik, Lake Oswego, Oregon, USA) balloon-mounted covered stent of a 23-year-old male with an enlarging cervical carotid artery pseudoaneurysm and progressive internal carotid artery stenosis. CASE DESCRIPTION: We report the management of a 23-year-old male with an enlarging cervical carotid artery pseudoaneurysm and progressive internal carotid artery stenosis...

BACKGROUND: Conduction system pacing (CSP) faces challenges in achieving reliable and safe deployments. Complex interactions between tissue and lead tip can result in endocardial entanglement, a drill effect that prevents penetration. No verified ex vivo model exists to quantitatively assess this relationship. OBJECTIVES: The purpose of this study was to quantitatively characterize CSP lead tip to tissue responses for 4 commonly used leads. METHODS: CSP leads (from Medtronic, Biotronik, Boston Scientific, and Abbott) were examined for helix rotation efficiency in ex vivo ovine right ventricular septa...

PURPOSE: To evaluate the safety, technical success and short-term effectiveness of polyurethane-covered stent (PK Papyrus, BioTronik, Berlin) in the treatment of pulmonary arteriovenous malformations (PAVMs) that are not amenable to embolotherapy. MATERIALS AND METHODS: In this IRB-approved, retrospective study, data from patients who received polyurethane-covered stents for exclusion of PAVMs were analyzed. The study included 5 patients (all women) with a median age of 40 years (range 25-60)...

BACKGROUND: The use of covered stent grafts for the treatment of carotid rupture is increasingly being used given their ability to preserve the parent artery while simultaneously occluding the fistula or rupture point. METHODS: This case series describes the technical feasibility of using, and the performance of, the PK Papyrus covered coronary stent (Biotronik, Inc., Lake Oswego, Oregon, USA) in six patients with carotid rupture, including carotid cavernous fistulas, between July 2021 and October 2023 in a single-center institution in the USA...

BACKGROUND: There is a scarcity of published head-to-head comparisons between different paclitaxel-coated angioplasty balloons. More prospective safety data to support the health care economic reimbursement processes are needed. OBJECTIVES: The aim of this study was to report the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) (Biotronik AG) for the treatment of symptomatic peripheral artery disease caused by stenosis, restenosis, or occlusion of the femoral and/or popliteal arteries...

BACKGROUND: There is a lack of evidence regarding contemporary implantable cardioverter-defibrillator (ICD) battery longevity. Our aim was to assess battery longevity in ICDs in a real-world setting. METHODS: Retrospective cross-sectional single center study of a prospectively collected database of consecutive patients who underwent ICD implantation from January 2010 to December 2015. Clinical data and battery longevity of all manufacturers were collected. RESULTS: A total of 351 patients (84...

Double-J ureteral stents are usually placed after various urological procedures. The dislodgement of their distal ringlet is a rare complication, whose retrieval is arduous in younger children, due to the small ureteral caliber. We propose our innovative endoscopic approach to recover the dislodged JJ stent. Under 8-9.8 Ch cystoscopy, the ureteral meatus is gently cannulated with a 00.18″ guidewire, then a balloon catheter Passeo 18 3-4 mm (Biotronik, Lake Oswego, OR, USA) is coaxially inserted. A pneumatic dilatation of the vesical-ureteral junction is performed up to 8 atmospheres for 5 minutes under direct vision...

AIMS: Transvenous lead extraction (TLE) of implantable cardioverter-defibrillator (ICD) leads is considered challenging. The structure of each ICD leads is variable between manufacturer and model families. The net impact of lead family on the safety and effectiveness of TLE is poorly characterized. We assessed the safety and efficacy of ICD TLE and the impact of manufacturer ICD model family on the outcomes. METHODS: The study cohort included all consecutive patients with ICD who underwent TLE between 2013-2022 and are enrolled in the Cleveland Clinic Prospective TLE Registry...

BACKGROUND: Plain old balloon angioplasty has been the mainstay of treatment for arteriovenous fistula (AVF) stenoses. Recent studies suggest that drug coated balloons (DCB) may significantly reduce re-intervention rates on native and recurrent lesions. The Passeo-18 Lux DCB (Biotronik AG, Buelach, Switzerland) is packaged with a 3.0 µg/mm2 dose of paclitaxel. The hypothesis is that its use provides better target lesion primary patency (TLPP), primary assisted patency (PP), secondary patency (SP) rates and reduces the number of visits for re-intervention in a cohort of patients with stenotic AVF and arteriovenous grafts (AVGs)...

Persistent left superior vena cava is the most common thoracic venous anomaly. It is usually asymptomatic, but it can make implanting intracardiac devices difficult.We present a novel technique to facilitate desfibrillator lead implantation in patients with persistent left superior vena cava and the absence of the right superior vena cava. We used a fixed-curve Selectra 3D 65-42 cm sheath (Biotronik), orienting it toward the tricuspid valve (TV) by rotating it counter-clockwise. During follow-up, the electrodes remained stable...

BACKGROUND: Biodegradable polymer sirolimus-eluting stents improve early stent-related clinical outcomes compared to durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. The long-term advantages of biodegradable polymer sirolimus-eluting stents after complete degradation of its polymer coating in patients with STEMI remains however uncertain. METHODS: BIOSTEMI Extended Survival (BIOSTEMI ES) was an investigator-initiated, follow-up extension study of the BIOSTEMI prospective, multicentre, single-blind, randomised superiority trial that compared biodegradable polymer sirolimus-eluting stents with durable polymer everolimus-eluting stents in patients with STEMI undergoing primary percutaneous coronary intervention at ten hospitals in Switzerland...

BACKGROUND: Cardiac implantable electronic devices (CIEDs) are an important means of atrial fibrillation (AF) detection. However, the AF burden measurements and notifications transmitted by CIEDs are not directly related to the clinical classification of paroxysmal, persistent, or permanent AF. Moreover, AF alerts are the most frequent form of notification, imposing a time-consuming review on caregivers. OBJECTIVE: The purpose of this study was to compare the incidence of standard AF burden-related notifications in remotely monitored (RM) patients with the incidence of events detected after filtering by a new proprietary algorithm implementing the standard European Society of Cardiology classification of AF...

BACKGROUND: Hitherto, lumen less leads (LLLs) were routinely utilized for conduction system pacing (CSP). We report the largest experience using stylet-driven leads (SDLs) with a deflectable mapping catheter for CSP. METHODS: Patients were prospectively and sequentially enrolled for CSP with SDL between June, 2021 and November, 2022 to (i) a novel deflectable mapping catheter (AgilisHisProTM , Abbott) (Group A) or (ii) a fixed curve sheath (Selectra3D, Biotronik) (Group B) in a 1:1 non-randomized fashion...

PURPOSE: Remote monitoring of cardiac devices reduces unnecessary outpatient visits and increases patient satisfaction. We aimed to evaluate remote monitoring in terms of patient satisfaction, economic efficiency, and safety. PATIENTS AND METHODS: This was a single university hospital survey. The time/medical cost efficacy and satisfaction index were evaluated using a questionnaire to investigate patient satisfaction before and after remote monitoring in patients using Biotronik implantable cardiac devices...

After the implantation of lower limb artery stents, the complex loading conditions imposed on the limb can lead to fatigue failure, which may induce inflammation and restenosis. To investigate the effect of multi-axial loading conditions on the fatigue performance of stents, five stents, namely APsolute Pro (APbott Vascular, USA), Complete SE (Medtronic, USA), Protégé EverFlex (PE3, USA), Pulsar-35 (Biotronik, Germany), and E-luminexx-B (Bard, USA), were analyzed based on the finite element method (FEM)...

BACKGROUND: Diabetes type 2 is one of the strongest risk factors affecting coronary artery disease (CAD) and is also a marker of poor short and long-term prognosis in subjects with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI) with subsequent drug-eluting stent (DES) implantation. Chronic local vascular inflammation along with endothelial dysfunction is postulated to be the pathophysiological background of unfavorable results. The second generation of metallic magnesium BRS -Magmaris (Biotronik, Berlin, Germany) had been introduced to clinical practice to overcome these limitations...

BACKGROUND: Pacing for vasovagal syncope is established. Two pacing algorithms are available. The rate-drop-response (RDR-Medtronic) is triggered by falling heart rate acting with modified rate-hysteresis. The closed loop stimulation or system (CLS-Biotronik) is triggered by impedance changes in the right ventricle reflecting falling volume and rising contractility. These are very different physiologically. Both algorithms carry favorable reports in clinical use. METHODS: A randomized-controlled superiority trial is proposed to compare the two algorithms for the control of vasovagal syncope in patients for whom pacing is indicated by current guidelines in North America and Europe...

BACKGROUND: Fidelity of electrogram sensing may reduce false alerts from insertable cardiac monitor (ICM). OBJECTIVE: To assess impact of vector length, implant angle and patient factors on electrogram sensing using surface electrocardiogram (EKG) mapping. METHODS: Twelve separate precordial single-lead surface EKGs were acquired from 150 participants at two inter-electrode distance (75mm & 45mm), three vector angles (vertical, oblique, horizontal) and in two postures (upright & supine)...