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  1. Artikel: Percutaneous Vacuum-Assisted Thrombectomy Device Used for Removal of Large Vegetations on Infected Pacemaker and Defibrillator Leads as an Adjunct to Lead Extraction.

    Schaerf, Raymond H M / Najibi, Sasan / Conrad, John

    Journal of atrial fibrillation

    2016  Band 9, Heft 3, Seite(n) 1455

    Abstract: This case series reports our early experience with a minimally invasive percutaneous method of safely removing large vegetations during lead extraction in septic cardiac implantable electronic devices (CIED). Debate exists concerning the management of ... ...

    Abstract This case series reports our early experience with a minimally invasive percutaneous method of safely removing large vegetations during lead extraction in septic cardiac implantable electronic devices (CIED). Debate exists concerning the management of vegetations involving these devices. Lead extraction is mandated for infections, but vegetations may embolize, causing complications. Surgical debridement is recommended; alternatives include cardiopulmonary bypass, minimally invasive thoracotomy, or transatrial approaches. The AngioVac device allows percutaneous right heart bypass and suction removal of vegetations under echocardiographic and fluoroscopic guidance. This case series describes our first 20 patients, all critically ill with persistent sepsis and vegetations despite long-term antibiotics. This series includes patients who would not have been eligible for alternative procedures due to contraindications and highlights the potential role of this new technology.
    Sprache Englisch
    Erscheinungsdatum 2016-10-31
    Erscheinungsland United States
    Dokumenttyp Journal Article
    ZDB-ID 2451936-4
    ISSN 1941-6911
    ISSN 1941-6911
    DOI 10.4022/jafib.1455
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  2. Artikel ; Online: Transcatheter aspiration of large pacemaker and implantable cardioverter-defibrillator lead vegetations facilitating safe transvenous lead extraction.

    Starck, Christoph T / Schaerf, Raymond H M / Breitenstein, Alexander / Najibi, Sasan / Conrad, John / Berendt, Joseph / Esmailian, Fardad / Eulert-Grehn, Jürgen / Dreizler, Thomas / Falk, Volkmar

    Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology

    2020  Band 22, Heft 1, Seite(n) 133–138

    Abstract: Aims: Treatment of patients with systemic cardiac implantable electronic device (CIED) infection with large lead vegetations is challenging and associated with relevant morbidity and mortality. To avoid complications from open surgical extraction, a ... ...

    Abstract Aims: Treatment of patients with systemic cardiac implantable electronic device (CIED) infection with large lead vegetations is challenging and associated with relevant morbidity and mortality. To avoid complications from open surgical extraction, a novel approach with percutaneous aspiration of large vegetations prior to transvenous lead extraction was instituted. The results of this treatment concept were retrospectively analysed in this multicentre study.
    Methods and results: One hundred and one patients [mean age 68.2 ± 13.1 (30-92) years] were treated in four centres for endovascular CIED infection with large lead vegetations. Mean lead vegetation size was 30.7 ± 13.5 mm. Two hundred and forty-seven leads were targeted for extraction (170 pacemaker leads, 77 implantable cardioverter-defibrillator leads). Mean lead implant duration was 81.7 (1-254) months. The transcatheter aspiration system with a specialized long venous drainage cannula and a funnel-shaped tip was based on a veno-venous extracorporeal circuit with an in-line filter. The aspiration of vegetations showed complete procedural success in 94.0% (n = 95), partial success in 5.0% (n = 5). Three major complications (3.0%) were encountered. Complete procedural success (per lead) of the subsequently performed transvenous lead extraction procedure was 99.2% (n = 245). Thirty-day mortality was 3.0% (n = 3). Five patients (5.0%) died in the further course on Days 51, 54, 68, 134, and 182 post-procedure (septic complications: n = 4; heart failure: n = 1).
    Conclusion: The percutaneous aspiration procedure is highly effective and is associated with a low complication profile. The aspiration of vegetations immediately prior and during the lead extraction procedure may avoid septic embolization into the pulmonary circulation. This may potentially lead to a long-term survival benefit.
    Mesh-Begriff(e) Adult ; Aged ; Aged, 80 and over ; Defibrillators, Implantable/adverse effects ; Device Removal ; Humans ; Middle Aged ; Pacemaker, Artificial/adverse effects ; Retrospective Studies ; Treatment Outcome
    Sprache Englisch
    Erscheinungsdatum 2020-12-04
    Erscheinungsland England
    Dokumenttyp Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 1449879-0
    ISSN 1532-2092 ; 1099-5129
    ISSN (online) 1532-2092
    ISSN 1099-5129
    DOI 10.1093/europace/euz283
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  3. Artikel ; Online: Extraction of chronically implanted coronary sinus leads active fixation vs passive fixation leads.

    Crossley, George H / Sorrentino, Robert A / Exner, Derek V / Merliss, Andrew D / Tobias, Serge M / Martin, David O / Augostini, Ralph / Piccini, Jonathan P / Schaerf, Raymond / Li, Shelby / Miller, Clayton T / Adler, Stuart W

    Heart rhythm

    2016  Band 13, Heft 6, Seite(n) 1253–1259

    Abstract: Background: The Medtronic model 4195 (StarFix) left ventricular lead is an active fixation lead that provides additional support within the coronary sinus (CS) via deployable lobes. While this lead has been shown to have excellent stability within the ... ...

    Abstract Background: The Medtronic model 4195 (StarFix) left ventricular lead is an active fixation lead that provides additional support within the coronary sinus (CS) via deployable lobes. While this lead has been shown to have excellent stability within the CS, concerns about its extractability have been raised.
    Objective: The aim of this study was to compare the safety and efficacy of the extraction of the model 4195 lead vs other Medtronic CS leads in a prospective cohort study.
    Methods: Patients undergoing extraction of this and other CS leads for standard indications were prospectively enrolled and studied. The primary outcomes of interest were the removal success rates and associated complication rates. Patients were followed for a month postprocedure.
    Results: The overall left ventricular lead extraction success rate was 97.6% (n = 205). Among 40 patients with chronic model 4195 leads, there were 37 successful extractions (92.5%) as compared to 98.8% for the 165 non-4195 leads. However, in 2 of the 3 StarFix lead extraction failures, standard extraction techniques were not used. All 10 of the model 4195 leads that had been implanted for less than 6 months were extracted without incident.
    Conclusion: In this largest study of CS lead extractions published to date, the overall success rate of the extraction of chronically implanted CS leads is high and the complication rate is similar in these lead models. The extraction of the model 4195 lead is clearly more challenging, but it can be accomplished in high-volume extraction centers with experienced operators. It is recommended that the model 4195 lead be extracted by experienced operators.
    Sprache Englisch
    Erscheinungsdatum 2016-06
    Erscheinungsland United States
    Dokumenttyp Journal Article
    ZDB-ID 2229357-7
    ISSN 1556-3871 ; 1547-5271
    ISSN (online) 1556-3871
    ISSN 1547-5271
    DOI 10.1016/j.hrthm.2016.01.031
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  4. Artikel ; Online: Multicenter experience with transvenous lead extraction of active fixation coronary sinus leads.

    Maytin, Melanie / Carrillo, Roger G / Baltodano, Pablo / Schaerf, Raymond H M / Bongiorni, Maria G / Di Cori, Andrea / Curnis, Antonio / Cooper, Joshua M / Kennergren, Charles / Epstein, Laurence M

    Pacing and clinical electrophysiology : PACE

    2012  Band 35, Heft 6, Seite(n) 641–647

    Abstract: Background/objective: Active fixation coronary sinus (CS) leads limit dislodgement and represent an attractive option to the implanter. Although extraction of passive fixation CS leads is a common and frequently uncomplicated procedure, data regarding ... ...

    Abstract Background/objective: Active fixation coronary sinus (CS) leads limit dislodgement and represent an attractive option to the implanter. Although extraction of passive fixation CS leads is a common and frequently uncomplicated procedure, data regarding extraction of chronically implanted active fixation CS leads are limited.
    Methods: We performed a retrospective cohort study of patients undergoing active fixation CS lead extraction at six centers. Patient and procedural characteristics, indications for extraction, use of extraction sheath (ES) assistance, and outcomes are reported.
    Results: Between January 2009 and February 2011, 12 patients underwent transvenous lead extraction (TLE) of Medtronic StarFix® lead (Medtronic Inc., Minneapolis, MN, USA). The cohort was 83% male with mean age 71 ± 14 years. Average implant duration was 14.2 ± 5.7 months (2.3-23.6). All leads but one were removed for infectious indications (67% systemic infection). At the time of explant, the fixation lobes were completely retracted in only one of the 12 cases and ES assistance was required for lead removal in all cases (58% laser, 25% cutting, 25% mechanical, and 25% femoral). The majority of cases required advancement of the sheath into the CS (75.0%) and often into a branch vessel (41.7%). One lead could not be removed transvenously and required surgical lead extraction. There were no major complications. Examination of the leads after extraction frequently revealed significant tissue growth into the fixation lobes.
    Conclusions: Although TLE of active fixation CS leads can be a safe procedure in select patients and experienced hands, powered sheaths and aggressive techniques are frequently required for successful removal despite relatively short implant durations. This raises significant concern regarding future TLE of active fixation CS leads with longer implant durations.
    Mesh-Begriff(e) Aged ; Cohort Studies ; Coronary Sinus/surgery ; Device Removal/adverse effects ; Device Removal/methods ; Electrodes, Implanted/adverse effects ; Female ; Humans ; Internationality ; Male ; Myocarditis/etiology ; Myocarditis/prevention & control ; Pacemaker, Artificial/adverse effects ; Prosthesis-Related Infections/etiology ; Prosthesis-Related Infections/surgery ; Retrospective Studies ; Treatment Outcome
    Sprache Englisch
    Erscheinungsdatum 2012-06
    Erscheinungsland United States
    Dokumenttyp Clinical Trial ; Journal Article ; Multicenter Study
    ZDB-ID 424437-0
    ISSN 1540-8159 ; 0147-8389
    ISSN (online) 1540-8159
    ISSN 0147-8389
    DOI 10.1111/j.1540-8159.2012.03353.x
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  5. Artikel ; Online: Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management: this document was endorsed by the American Heart Association (AHA).

    Wilkoff, Bruce L / Love, Charles J / Byrd, Charles L / Bongiorni, Maria Grazia / Carrillo, Roger G / Crossley, George H / Epstein, Laurence M / Friedman, Richard A / Kennergren, Charles E H / Mitkowski, Przemyslaw / Schaerf, Raymond H M / Wazni, Oussama M

    Heart rhythm

    2009  Band 6, Heft 7, Seite(n) 1085–1104

    Mesh-Begriff(e) Cardiac Pacing, Artificial ; Consensus ; Device Removal/education ; Device Removal/methods ; Device Removal/standards ; Electrodes, Implanted ; Heart Diseases/therapy ; Humans ; Pacemaker, Artificial
    Sprache Englisch
    Erscheinungsdatum 2009-07
    Erscheinungsland United States
    Dokumenttyp Consensus Development Conference ; Journal Article ; Practice Guideline
    ZDB-ID 2229357-7
    ISSN 1556-3871 ; 1547-5271
    ISSN (online) 1556-3871
    ISSN 1547-5271
    DOI 10.1016/j.hrthm.2009.05.020
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  6. Artikel ; Online: Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator.

    Russo, Robert J / Costa, Heather S / Silva, Patricia D / Anderson, Jeffrey L / Arshad, Aysha / Biederman, Robert W W / Boyle, Noel G / Frabizzio, Jennifer V / Birgersdotter-Green, Ulrika / Higgins, Steven L / Lampert, Rachel / Machado, Christian E / Martin, Edward T / Rivard, Andrew L / Rubenstein, Jason C / Schaerf, Raymond H M / Schwartz, Jennifer D / Shah, Dipan J / Tomassoni, Gery F /
    Tominaga, Gail T / Tonkin, Allison E / Uretsky, Seth / Wolff, Steven D

    The New England journal of medicine

    2017  Band 376, Heft 8, Seite(n) 755–764

    Abstract: Background: The presence of a cardiovascular implantable electronic device has long been a contraindication for the performance of magnetic resonance imaging (MRI). We established a prospective registry to determine the risks associated with MRI at a ... ...

    Abstract Background: The presence of a cardiovascular implantable electronic device has long been a contraindication for the performance of magnetic resonance imaging (MRI). We established a prospective registry to determine the risks associated with MRI at a magnetic field strength of 1.5 tesla for patients who had a pacemaker or implantable cardioverter-defibrillator (ICD) that was "non-MRI-conditional" (i.e., not approved by the Food and Drug Administration for MRI scanning).
    Methods: Patients in the registry were referred for clinically indicated nonthoracic MRI at a field strength of 1.5 tesla. Devices were interrogated before and after MRI with the use of a standardized protocol and were appropriately reprogrammed before the scanning. The primary end points were death, generator or lead failure, induced arrhythmia, loss of capture, or electrical reset during the scanning. The secondary end points were changes in device settings.
    Results: MRI was performed in 1000 cases in which patients had a pacemaker and in 500 cases in which patients had an ICD. No deaths, lead failures, losses of capture, or ventricular arrhythmias occurred during MRI. One ICD generator could not be interrogated after MRI and required immediate replacement; the device had not been appropriately programmed per protocol before the MRI. We observed six cases of self-terminating atrial fibrillation or flutter and six cases of partial electrical reset. Changes in lead impedance, pacing threshold, battery voltage, and P-wave and R-wave amplitude exceeded prespecified thresholds in a small number of cases. Repeat MRI was not associated with an increase in adverse events.
    Conclusions: In this study, device or lead failure did not occur in any patient with a non-MRI-conditional pacemaker or ICD who underwent clinically indicated nonthoracic MRI at 1.5 tesla, was appropriately screened, and had the device reprogrammed in accordance with the prespecified protocol. (Funded by St. Jude Medical and others; MagnaSafe ClinicalTrials.gov number, NCT00907361 .).
    Mesh-Begriff(e) Adult ; Aged ; Aged, 80 and over ; Atrial Fibrillation/etiology ; Atrial Flutter/etiology ; Contraindications ; Defibrillators, Implantable ; Equipment Failure ; Female ; Humans ; Magnetic Resonance Imaging/adverse effects ; Male ; Middle Aged ; Pacemaker, Artificial ; Prospective Studies ; Registries
    Sprache Englisch
    Erscheinungsdatum 2017--23
    Erscheinungsland United States
    Dokumenttyp Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't ; Comment
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMoa1603265
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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