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Marc Bentele – 1st expert on this subject based on the ideXlab platform

  • TWO-YEAR RESULTS AFTER IMPLANTATION OF AN ULTRATHIN, BIORESORBABLE POLYMER SIROLIMUS-ELUTING CORONARY STENT COMPARED TO A THIN, DURABLE POLYMER EVEROLIMUS-ELUTING STENT: HEALTH ECONOMIC EVALUATION
    Journal of the American College of Cardiology, 2019
    Co-Authors: Soeren Mattke, Anissa C. Dallmann, Mark Alan Hanson, Marc Bentele

    Abstract:

    The recent BIOFLOW V trial (ClinicalTrials.gov: [NCT02389946][1]) showed that the Orsiro ultrathin, bioresorbable polymer sirolimus-eluting stent (BP SES) (Biotronik, Buelach, Switzerland) was in statistical favor to the Xience thin, durable polymer everolimus-eluting stent (DP EES) (Abbott Vascular

  • 100.63 Health Economic Evaluation of the Two-Year Results After Implantation of an Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Coronary Stent Compared to a Thin, Durable-Polymer Everolimus-Eluting Stent
    Jacc-cardiovascular Interventions, 2019
    Co-Authors: Soeren Mattke, Mark Hanson, Anissa C. Dallmann, Marc Bentele

    Abstract:

    The recent BIOFLOW V trial (ClinicalTrials.gov: [NCT02389946][1]) showed that the Orsiro ultrathin, bioresorbable-polymer sirolimus-eluting stent (BP SES) (Biotronik, Buelach, Switzerland) had lower rates of both clinically driven target lesion revascularization (TLR) and target vessel-related

T Meinertz – 2nd expert on this subject based on the ideXlab platform

  • Effects of a thin-sized lead body of a transvenous single coil defibrillation lead on ICD implantation. Kainox RV Study Group.
    Pacing and clinical electrophysiology : PACE, 2020
    Co-Authors: A Schuchert, T Meinertz

    Abstract:

    In the interest of patients receiving implantable cardioverter defibrillators (ICDs), the clinical benefits of newer and thinner transvenous defibrillation leads have to be determined. The aims of this study were to evaluate the ICD procedure duration and the frequency of lead dislocation at the 3-month follow-up of a new defibrillation lead with a thin-sized lead body and its conventional-sized predecessor. The thin-sized single coil defibrillation lead (Kainox RV, Biotronik; lead body 6.7 Fr) was implanted in 61 patients and the conventional-sized defibrillation lead (SPS, Biotronik; lead body 7.8 Fr) in 60 patients. Both leads were connected to a left-sided, prepectorally implanted Phylax ICD (Biotronik) with active housing. The lead implantation time and total procedure duration were determined. Lead implantation time was defined as the time from lead insertion to the end of the pacing measurements. The total procedure duration spanned skin incision to closure. The incidence of lead repositioning during the lead implantation time and during ventricular fibrillation conversion testing was also assessed. The frequency of lead dislocations was recorded at the 3-month follow-up. Mean lead implantation time and total procedure duration of the thin-sized lead (23 +/- 22 minutes 76 +/- 37 minutes) were not statistically different from the time needed for the conventional-sized lead (22 +/- 20 minutes 81 +/- 34 minutes). The number of lead repositionings during the lead implantation time was similar (thin-sized lead: 1.4 +/- 2.4; conventional-sized lead: 1.1 +/- 1.9). An additional lead repositioning was not necessary during ventricular fibrillation conversion testing in 93.4% of the patients with thin-sized and in 94.4% with conventional-sized leads (not significant). At the 3-month follow-up, there were four (6.6%) lead dislocations in the thin-sized and four (6.7%) in the conventional-sized lead group. In conclusion, the down-sized lead body of the new defibrillation lead influenced neither ICD procedure duration nor the incidence of lead dislocation during follow-up.

  • Effects of a Thin-Sized Lead Body of a Transvenous Single Coil Defibrillation Lead on ICD Implantation
    Pacing and Clinical Electrophysiology, 2000
    Co-Authors: A Schuchert, T Meinertz

    Abstract:

    SCHUCHERT, A., et al.: Effects of a Thin-Sized Lead Body of a Transvenous Single Coil Defibrillation Lead on ICD Implantation. In the interest of patients receiving implantable cardioverter defibrillators (ICDs), the clinical benefits of newer and thinner transvenous defibrillation leads have to be determined. The aims of this study were to evaluate the ICD procedure duration and the frequency of lead dislocation at the 3-month follow-up of a new defibrillation lead with a thin-sized lead body and its conventionalsized predecessor. The thin-sized single coil defibrillation lead (Kainox RV, Biotronik; lead body 6.7 Fr) was implanted in 61 patients and the conventional-sized defibrillation lead (SPS, Biotronik; lead body 7.8 Fr) in 60 patients. Both leads were connected to a left-sided, prepectorally implanted Phylax ICD (Biotronik) with active housing. The lead implantation time and total procedure duration were determined. Lead implantation time was defined as the time from lead insertion to the end of the pacing measurements. The total procedure duration spanned skin incision to closure. The incidence of lead repositioning during the lead implantation time and during ventricular fibrillation conversion testing was also assessed. The frequency of lead dislocations was recorded at the 3-month follow-up. Mean lead implantation time and total procedure duration of the thin-sized lead (23 ± 22 minutes 76 ± 37 minutes) were not statistically different from the time needed for the conventional-sized lead (22 ± 20 minutes 81 ± 34 minutes). The number of lead repositionings during the lead implantation time was similar (thin-sized lead: 1.4 ± 2.4; conventional-sized lead: 1.1 ± 1.9). An additional lead repositioning was not necessary during ventricular fibrillation conversion testing in 93.4% of the patients with thin-sized and in 94.4% with conventional-sized leads (not significant). At the 3-month follow-up, there were four (6.6%) lead dislocations in the thin-sized and four (6.7%) in the conventional-sized lead group. In conclusion, the downsized lead body of the new defibrillation lead influenced neither ICD procedure duration nor the incidence of lead dislocation during follow-up.

Andreas Kucher – 3rd expert on this subject based on the ideXlab platform

  • Left ventricular inhibition during cardiac resynchronization caused by sensed left-sided ventricular premature complexes.
    Pacing and Clinical Electrophysiology, 2020
    Co-Authors: S. Serge Barold, Andreas Kucher

    Abstract:

    : A recently published case documented left ventricular (LV) inhibition of a Boston Scientific device by a premature complex (VPC) that was undetected by the right ventricular channel. We have observed a similar response in two patients with a Biotronik cardiac resynchronization device also designed with LV sensing. A spurious response simulating that of the two true cases was also observed in a third patient with a defective LV lead which created isolated false signals. The responses of the Biotronik devices were identical to that of the previously reported findings with the Boston Scientific device. The observations provide insight into the timing function of cardiac resynchronization devices designed with LV sensing.

  • Interruption of cardiac resynchronization therapy by atrial premature complexes
    Journal of Electrocardiology, 2017
    Co-Authors: S. Serge Barold, Andreas Kucher

    Abstract:

    Abstract Biotronik devices used for cardiac resynchronization therapy (CRT) combined with defibrillation function (CRT-D) are capable of left ventricular (LV) sensing. Under certain circumstances, LV sensing may cause loss of CRT. The third generation of the Biotronik i-family CRT-Ds enables the recording of event-triggered tracings of the electrogram particularly those involving “CRT pacing interrupt” episodes. We report three cases of a sudden “CRT pacing interrupt” initiated by an atrial premature complex. This was caused by realignment of the LV timing cycles induced by the APCs whereupon LV pacing was inhibited and a self-perpetuating desynchronization process was initiated. In all cases it is the repeated occurrence of LV sensed events that prevents the emission of LV paced events because it displaces the LV upper rate interval from its normal position. Prevention of desynchronization requires programming an LV upper rate faster than the maximum sensor-driven rate or right ventricular upper rate.

  • The Analog Blanking Period of Implantable Cardiac Rhythm Devices.
    Pacing and Clinical Electrophysiology, 2017
    Co-Authors: S. Serge Barold, Andreas Kucher

    Abstract:

    Background
    Analog blanking periods (BPs) that hold down the display of electrograms (EGMs) in cardiac rhythm devices have received much less attention than the well-known digital BPs which do not influence the EGM display. In Biotronik devices (Biotronik GmbH, Berlin, Germany), when a paced event initiates an analog BP in one chamber (right atrium, right ventricle [RV], or left ventricle [LV]), an identical cross-chamber analog BP starts in the other two chambers.

    Methods
    All clinical observations were recorded from patients with Biotronik devices. The effect of the atrial cross-chamber analog BP initiated by a ventricular paced event on the atrial EGM was studied in the records of seven patients with frequent paroxysmal atrial flutter to determine the effect of critically timed RV paced event (RVp) or LV paced event (LVp) upon the atrial EGM. The effect of atrial pacing triggering cross-chamber analog BPs in the RV and LV channels on the RV and LV EGMs was also investigated in cases of conducted supraventricular beats and ventricular premature complexes. The effect of a triggered LVp initiating a cross-chamber analog BP in the RV channel on the EGM of a sensed RV sensed event was evaluated in 10 cases. Simulation studies were also performed to verify the clinical observations.

    Results
    Patients with atrial flutter showed intermittent truncation or deformity and even disappearance of the atrial signals due to an atrial cross-chamber analog BP initiated by RVp and/or LVp. Three patients demonstrated deformity of the signal shape of ventricular premature beats falling within a ventricular cross-chamber analog BP initiated by right atrial paced event (RAp). We found only one case of a supraventricular QRS complex trapped in a ventricular cross-chamber analog BP initiated by RAp. All the recordings of LVp triggering upon RVs revealed a variety of RV signal deformities occasionally with preservation of the terminal part of the RV signal. Simulation studies confirmed the effect of the analog BP on the atrial and the ventricular EGMs.

    Conclusion
    The analog BP of Biotronik devices may cause truncation or deformity of atrial and ventricular signals and the occasional disappearance of an atrial signal during atrial flutter. These effects must not be interpreted as device malfunction. In the clinical evaluation of the EGM curves, the effects of the analog BPs have to be carefully considered in order to avoid possible misinterpretation.