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Process Mapping Strategies to Prevent Subcutaneous Implantable Cardioverter-Defibrillator Infection

Raul Weiss, George Mark, Mikhael El-Chami, Mauro Biffi, VINCENT PROBST, Pier Lambiase, Marc Miller, Timothy McClernon, Linda Hansen, Bradley Knight, Larry Baddour,

<h4>Background: </h4> Infection remains a major complication of cardiac implantable electronic devices (CIEDs) and can lead to significant morbidity and mortality. Extrathoracic devices that avoid epicardial or transvenous leads, such as the subcutaneous implantable cardioverter-defibrillator (S-ICD), can reduce the risk of serious infection-related complications, such as bloodstream infection and infective ... Read more >>

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Efficacy and Safety of Appropriate Shocks and Antitachycardia Pacing in Transvenous and Subcutaneous Implantable Defibrillators: An Analysis of All Appropriate Therapy in the PRAETORIAN trial.

Reinoud E Knops, Willeke van der Stuijt, Peter Paul H M Delnoy, Lucas V A Boersma, Juergen Kuschyk, Mikhael F El-Chami, Hendrik Bonnemeier, Elijah R Behr, Tom F Brouwer, Stefan Kaab, Suneet Mittal, Anne-Floor B E Quast, Lonneke Smeding, Jan G P Tijssen, Nick R Bijsterveld, Sergio Richter, Marc A Brouwer, Joris R de Groot, Kirsten M Kooiman, Pier D Lambiase, Petr Neuzil, Kevin Vernooy, Marco Alings, Timothy R Betts, Frank A L E Bracke, Martin C Burke, Jonas S S G de Jong, David J Wright, Ward P J Jansen, Zachary I Whinnett, Peter Nordbeck, Michael Knaut, Berit T Philbert, Jurren M van Opstal, Alexandru B Chicos, Cornelis P Allaart, Alida E Borger van der Burg, Jude F Clancy, Jose M Dizon, Marc A Miller, Dmitry Nemirovsky, Ralf Surber, Gaurav A Upadhyay, Raul Weiss, Anouk de Weger, Arthur A M Wilde, Louise R A Olde Nordkamp, ,

<b>Background:</b> The PRAETORIAN trial showed non-inferiority of the subcutaneous implantable cardioverter-defibrillator (S-ICD) compared to the transvenous ICD (TV-ICD) with regard to inappropriate shocks and complications. In contrast to the TV-ICD, the S-ICD cannot provide antitachycardia pacing (ATP) for monomorphic ventricular tachycardia (VT). This pre-specified secondary analysis evaluates appropriate therapy and ... Read more >>

Circulation (Circulation)
[2021, :]

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A 10 J shock impedance in sinus rhythm correlates with a 65 J defibrillation impedance during subcutaneous defibrillator implantation using an intermuscular technique.

Toshimasa Okabe, Salvatore J Savona, Faisal Matto, Chad Ward, Prabhpreet Singh, Muhammad R Afzal, Steven J Kalbfleisch, Raul Weiss, Mahmoud Houmsse, Ralph S Augostini, John D Hummel, Emile G Daoud,

<h4>Introduction</h4>Defibrillation testing (DT) is recommended during the subcutaneous defibrillator (S-ICD) placement. We sought to compare 10 J shock impedance in sinus rhythm (SR) with 65 J defibrillation impedance and evaluate device position on a postimplant chest X-ray (CXR) using an intermuscular (IM) technique.<h4>Methods</h4>Consecutive S-ICD implantations between 12/2019 and 12/2020 at The Ohio ... Read more >>

J Cardiovasc Electrophysiol (Journal of cardiovascular electrophysiology)
[2021, 32(11):3027-3034]

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The genomics of heart failure: design and rationale of the HERMES consortium.

R Thomas Lumbers, Sonia Shah, Honghuang Lin, Tomasz Czuba, Albert Henry, Daniel I Swerdlow, Anders Mälarstig, Charlotte Andersson, Niek Verweij, Michael V Holmes, Johan Ärnlöv, Per Svensson, Harry Hemingway, Neneh Sallah, Peter Almgren, Krishna G Aragam, Geraldine Asselin, Joshua D Backman, Mary L Biggs, Heather L Bloom, Eric Boersma, Jeffrey Brandimarto, Michael R Brown, Hans-Peter Brunner-La Rocca, David J Carey, Mark D Chaffin, Daniel I Chasman, Olympe Chazara, Xing Chen, Xu Chen, Jonathan H Chung, William Chutkow, John G F Cleland, James P Cook, Simon de Denus, Abbas Dehghan, Graciela E Delgado, Spiros Denaxas, Alexander S Doney, Marcus Dörr, Samuel C Dudley, Gunnar Engström, Tõnu Esko, Ghazaleh Fatemifar, Stephan B Felix, Chris Finan, Ian Ford, Francoise Fougerousse, René Fouodjio, Mohsen Ghanbari, Sahar Ghasemi, Vilmantas Giedraitis, Franco Giulianini, John S Gottdiener, Stefan Gross, Daníel F Guðbjartsson, Hongsheng Gui, Rebecca Gutmann, Christopher M Haggerty, Pim van der Harst, Åsa K Hedman, Anna Helgadottir, Hans Hillege, Craig L Hyde, Jaison Jacob, J Wouter Jukema, Frederick Kamanu, Isabella Kardys, Maryam Kavousi, Kay-Tee Khaw, Marcus E Kleber, Lars Køber, Andrea Koekemoer, Bill Kraus, Karoline Kuchenbaecker, Claudia Langenberg, Lars Lind, Cecilia M Lindgren, Barry London, Luca A Lotta, Ruth C Lovering, Jian'an Luan, Patrik Magnusson, Anubha Mahajan, Douglas Mann, Kenneth B Margulies, Nicholas A Marston, Winfried März, John J V McMurray, Olle Melander, Giorgio Melloni, Ify R Mordi, Michael P Morley, Andrew D Morris, Andrew P Morris, Alanna C Morrison, Michael W Nagle, Christopher P Nelson, Christopher Newton-Cheh, Alexander Niessner, Teemu Niiranen, Christoph Nowak, Michelle L O'Donoghue, Anjali T Owens, Colin N A Palmer, Guillaume Paré, Markus Perola, Louis-Philippe Lemieux Perreault, Eliana Portilla-Fernandez, Bruce M Psaty, Kenneth M Rice, Paul M Ridker, Simon P R Romaine, Carolina Roselli, Jerome I Rotter, Christian T Ruff, Marc S Sabatine, Perttu Salo, Veikko Salomaa, Jessica van Setten, Alaa A Shalaby, Diane T Smelser, Nicholas L Smith, Kari Stefansson, Steen Stender, David J Stott, Garðar Sveinbjörnsson, Mari-Liis Tammesoo, Jean-Claude Tardif, Kent D Taylor, Maris Teder-Laving, Alexander Teumer, Guðmundur Thorgeirsson, Unnur Thorsteinsdottir, Christian Torp-Pedersen, Stella Trompet, Danny Tuckwell, Benoit Tyl, Andre G Uitterlinden, Felix Vaura, Abirami Veluchamy, Peter M Visscher, Uwe Völker, Adriaan A Voors, Xiaosong Wang, Nicholas J Wareham, Peter E Weeke, Raul Weiss, Harvey D White, Kerri L Wiggins, Heming Xing, Jian Yang, Yifan Yang, Laura M Yerges-Armstrong, Bing Yu, Faiez Zannad, Faye Zhao, , Jemma B Wilk, Hilma Holm, Naveed Sattar, Steven A Lubitz, David E Lanfear, Svati Shah, Michael E Dunn, Quinn S Wells, Folkert W Asselbergs, Aroon D Hingorani, Marie-Pierre Dubé, Nilesh J Samani, Chim C Lang, Thomas P Cappola, Patrick T Ellinor, Ramachandran S Vasan, J Gustav Smith,

<h4>Aims</h4>The HERMES (HEart failure Molecular Epidemiology for Therapeutic targetS) consortium aims to identify the genomic and molecular basis of heart failure.<h4>Methods and results</h4>The consortium currently includes 51 studies from 11 countries, including 68 157 heart failure cases and 949 888 controls, with data on heart failure events and prognosis. All studies collected ... Read more >>

ESC Heart Fail (ESC heart failure)
[2021, 8(6):5531-5541]

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Back to the Future: Defibrillation Energy Requirements, Testing New Technology With Old Concepts.

Raul Weiss, Mahmoud Houmsse,

JACC Clin Electrophysiol (JACC. Clinical electrophysiology)
[2021, 7(6):777-780]

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Device-related infection in de novo transvenous implantable cardioverter-defibrillator Medicare patients.

Mikhael F El-Chami, Caroline M Jacobsen, Robert I Griffiths, Linda K Hansen, Nick Wold, Stacey L Amorosi, Timothy M Stivland, Bradley P Knight, Raul Weiss, George E Mark, Mauro Biffi, Vincent Probst, Pier D Lambiase, Marc A Miller, Larry M Baddour,

<h4>Background</h4>Cardiac device infection is a serious complication of implantable cardioverter-defibrillator (ICD) placement and requires complete device removal with accompanying antimicrobial therapy for durable cure. Recent guidelines have highlighted the need to better identify patients at high risk of infection to assist in device selection.<h4>Objective</h4>To estimate the prevalence of infection in ... Read more >>

Heart Rhythm (Heart rhythm)
[2021, 18(8):1301-1309]

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Point/Counterpoint on Halting Implantation of the Subcutaneous ICD.

John Mandrola, Bogdan Enache, Raul Weiss, Emile G Daoud,

JACC Clin Electrophysiol (JACC. Clinical electrophysiology)
[2021, 7(5):685-689]

Cited: 1 time

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Esophageal deviation with vacuum suction and mechanical deflection during ablation of atrial fibrillation: First in man evaluation.

Luis Aguinaga, Emile G Daoud, Veeral Oza, Raul Weiss,

J Cardiovasc Electrophysiol (Journal of cardiovascular electrophysiology)
[2021, 32(4):1211-1212]

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Outcomes of two versus three incision techniques: Results from the subcutaneous ICD post-approval study.

Mikhael El-Chami, Raul Weiss, Martin C Burke, Michael R Gold, Jordan M Prutkin, Gautham Kalahasty, Sharon Shen, Michael J Mirro, Nathan Carter, Johan D Aasbo,

<h4>Background</h4>Traditionally, implantation of the subcutaneous implantable cardioverter defibrillator (S-ICD) requires incisions near the lateral chest wall, the xyphoid, and the superior sternal region (three-incision technique [3IT]). A two-incision technique (2IT) avoids the superior incision and has been shown to be a viable alternative in small studies with limited follow-up.<h4>Objectives</h4>To report ... Read more >>

J Cardiovasc Electrophysiol (Journal of cardiovascular electrophysiology)
[2021, 32(3):792-801]

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Resource Use and Economic Implications of Remote Monitoring With Subcutaneous Cardiac Rhythm Monitors.

Muhammad R Afzal, Anish Nadkarni, Laurie Niemet, Mustafa Houmsse, Jasneet Devgun, Tanner Koppert, Kalyn Ferguson, Julie Mease, Toshimasa Okabe, Mahmoud Houmsse, Ralph S Augostini, Raul Weiss, John D Hummel, Emile G Daoud, Steven J Kalbfleisch,

<h4>Objectives</h4>This study reports resource use and economic implications of rhythm monitoring with subcutaneous cardiac rhythm monitors (SCRMs).<h4>Background</h4>SCRMs generate a substantial amount of data that requires timely adjudication for appropriate clinical care. Resource use for SCRM monitoring is not known.<h4>Methods</h4>The study included consecutive transmissions during 4 weeks from 1,811 SCRMs. Resource use ... Read more >>

JACC Clin Electrophysiol (JACC. Clinical electrophysiology)
[2021, 7(6):745-754]

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Incidence of pacing-induced cardiomyopathy in pacemaker-dependent patients is lower with leadless pacemakers compared to transvenous pacemakers.

Reynaldo Sanchez, Anish Nadkarni, Benjamin Buck, Georges Daoud, Tanner Koppert, Toshimasa Okabe, Mahmoud Houmsse, Raul Weiss, Ralph Augostini, John D Hummel, Steven Kalbfleisch, Emile G Daoud, Muhammad R Afzal,

<h4>Introduction</h4>Frequent right AQ4ventricular pacing (≥40%) with a transvenous pacemaker (TVP) is associated with the risk of pacing-induced cardiomyopathy (PICM). Leadless pacemakers (LPs) have distinct physical and mechanical differences from TVP. The risk of PICM with LP is not known. To identify incidence, predictors, and long-term outcomes of PICM in LP ... Read more >>

J Cardiovasc Electrophysiol (Journal of cardiovascular electrophysiology)
[2021, 32(2):477-483]

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Incidence and Risk Factors for Early Explantation of Subcutaneous Cardiac Rhythm Monitors.

Muhammad R Afzal, Amy Casmer, Benjamin Buck, Mahmoud Houmsse, Emile G Daoud, Steven J Kalbfleisch, Ralph S Augostini, Raul Weiss, John D Hummel, Toshimasa Okabe,

JACC Clin Electrophysiol (JACC. Clinical electrophysiology)
[2020, 6(14):1858-1860]

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Esophageal deviation with vacuum suction and mechanical deflection during ablation of atrial fibrillation: First in man evaluation.

Luis Aguinaga, Alejandro Palazzo, Alejandro Bravo, Gabriela Lizarraga, Daisy Sandoval, Eduardo Figueroa, Teresa Juri, Emile G Daoud, Raul Weiss,

Deviation of the esophagus during atrial fibrillation (AF) ablation can reduce esophageal injury. This study reports upon a novel esophageal retractor that utilizes vacuum suction and mechanical deflection to deviate the esophagus. The device was used in seven patients undergoing cryoballoon AF ablation. The esophagus was deviated 31.9 ± 4.4 mm to the ... Read more >>

J Cardiovasc Electrophysiol (Journal of cardiovascular electrophysiology)
[2021, 32(1):67-70]

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Trends in anticoagulation management services following incorporation of direct oral anticoagulants at a large academic medical center.

Caitlin Mills, Melissa J Snider, Tiffany C Ortman, Aaron Dush, Margueritte S Hevezi, Junan Li, Raul Weiss, Eric Kraut,

The introduction of direct oral anticoagulants (DOACs) to the market has expanded anticoagulation options for outpatient use. Routine evaluation by health care professionals is recommended as it is with warfarin, therefore requiring adjustments in practices of anticoagulation management services (AMS). This study aims to describe trends that occurred following the ... Read more >>

J Thromb Thrombolysis (Journal of thrombosis and thrombolysis)
[2021, 51(4):1050-1058]

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Perioperative considerations during implantation of the subcutaneous defibrillator: State-of-the-art review.

Prabhpreet Singh, Muhammad Rizwan Afzal, Raul Weiss,

The subcutaneous implantable cardioverter-defibrillator (S-ICD) is an important tool in the armamentarium of an electrophysiologist. Multiple randomized trials over the last decade have shown that S-ICDs are as efficacious as the transvenous ICDs and eliminate complications related to vascular access. In this review, we highlight issues unique to S-ICD implantation, ... Read more >>

Pacing Clin Electrophysiol (Pacing and clinical electrophysiology : PACE)
[2020, 43(12):1451-1458]

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Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial.

Michael R Gold, Pier D Lambiase, Mikhael F El-Chami, Reinoud E Knops, Johan D Aasbo, Maria Grazia Bongiorni, Andrea M Russo, Jean-Claude Deharo, Martin C Burke, Jay Dinerman, Craig S Barr, Naushad Shaik, Nathan Carter, Thomas Stoltz, Kenneth M Stein, Amy J Brisben, Lucas V A Boersma, ,

<h4>Background</h4>The subcutaneous (S) implantable cardioverter-defibrillator (ICD) is safe and effective for sudden cardiac death prevention. However, patients in previous S-ICD studies had fewer comorbidities, had less left ventricular dysfunction, and received more inappropriate shocks (IAS) than in typical transvenous ICD trials. The UNTOUCHED trial (Understanding Outcomes With the S-ICD in ... Read more >>

Circulation (Circulation)
[2021, 143(1):7-17]

Cited: 5 times

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1-Year Prospective Evaluation of Clinical Outcomes and Shocks: The Subcutaneous ICD Post Approval Study.

Martin C Burke, Johan D Aasbo, Mikhael F El-Chami, Raul Weiss, Jay Dinerman, Sam Hanon, Gauthem Kalahasty, Eric Bass, Michael R Gold,

<h4>Objectives</h4>This study evaluated spontaneous arrhythmias and clinical outcomes in the S-ICD System PAS (Subcutaneous Implantable Cardioverter-Defibrillator Post Approval Study) cohort.<h4>Background</h4>The U.S. S-ICD PAS trial patient population more closely resembles transvenous ICD cohorts than earlier studies, which included many patients with little structural heart disease and few comorbidities. Early outcomes and ... Read more >>

JACC Clin Electrophysiol (JACC. Clinical electrophysiology)
[2020, 6(12):1537-1550]

Cited: 2 times

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Subcutaneous or Transvenous Defibrillator Therapy.

Reinoud E Knops, Louise R A Olde Nordkamp, Peter-Paul H M Delnoy, Lucas V A Boersma, Jürgen Kuschyk, Mikhael F El-Chami, Hendrik Bonnemeier, Elijah R Behr, Tom F Brouwer, Stefan Kääb, Suneet Mittal, Anne-Floor B E Quast, Lonneke Smeding, Willeke van der Stuijt, Anouk de Weger, Koen C de Wilde, Nick R Bijsterveld, Sergio Richter, Marc A Brouwer, Joris R de Groot, Kirsten M Kooiman, Pier D Lambiase, Petr Neuzil, Kevin Vernooy, Marco Alings, Tim R Betts, Frank A L E Bracke, Martin C Burke, Jonas S S G de Jong, David J Wright, Jan G P Tijssen, Arthur A M Wilde, ,

<h4>Background</h4>The subcutaneous implantable cardioverter-defibrillator (ICD) was designed to avoid complications related to the transvenous ICD lead by using an entirely extrathoracic placement. Evidence comparing these systems has been based primarily on observational studies.<h4>Methods</h4>We conducted a noninferiority trial in which patients with an indication for an ICD but no indication for ... Read more >>

N Engl J Med (The New England journal of medicine)
[2020, 383(6):526-536]

Cited: 24 times

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How to minimize peri-procedural complications during subcutaneous defibrillator implant?

Muhammad R Afzal, Toshimasa Okabe, Kevin Hsu, Schuyler Cook, Tanner Koppert, Raul Weiss,

<h4>Introduction</h4>Subcutaneous defibrillator (S-ICD) is the latest development in the clinically available devices for sudden cardiac death prevention. Experience from pivotal trials and post-marketing studies has proven the feasibility and safety of S-ICD. Extra-cardiac location of S-ICD obviates the need for transvenous leads which translates into lower incidence of lead-related complications ... Read more >>

Expert Rev Cardiovasc Ther (Expert review of cardiovascular therapy)
[2020, 18(7):427-434]

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Extreme Obesity is Associated with Low Success Rate of Atrial Fibrillation Catheter Ablation.

Toshimasa Okabe, Benjamin Buck, Samuel A Hayes, Thura T Harfi, Muhammad R Afzal, Jaret Tyler, Mahmoud Houmsse, Steven J Kalbfleisch, Raul Weiss, John D Hummel, Ralph S Augostini, Emile G Daoud,

<h4>Background</h4>Catheter ablation (CA) is an established treatment for patients with symptomatic atrial fibrillation (AF). The purpose of this study was to evaluate the safety and efficacy of single CA in AF patients with extreme obesity (body mass index [BMI] ≥ 40 kg/m2) and its long-term impact on body weight.<h4>Methods</h4>Patients with ... Read more >>

J Atr Fibrillation (Journal of atrial fibrillation)
[2020, 12(6):2242]

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Evaluation of a novel esophageal retractor utilizing vacuum suction and mechanical force for deviating the esophagus.

Mahmoud Houmsse, Emile G Daoud, Matthew Joseph, Raul Weiss, Michael Essandoh,

<h4>Background</h4>Deviation of the esophagus prevents esophageal injury during atrial fibrillation ablation.<h4>Objectives</h4>This study is to evaluate, in animals, safety and effectiveness of a novel esophageal retractor that utilizes vacuum suction and mechanical force to deviate the esophagus.<h4>Methods</h4>Following general anesthesia, a radiopaque ruler was placed behind the animal perpendicular to the esophagus. ... Read more >>

J Cardiovasc Electrophysiol (Journal of cardiovascular electrophysiology)
[2020, 31(7):1661-1669]

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BioMonitor 2 in-office setting insertion safety and feasibility evaluation with device functionality assessment: results from the prospective cohort BioInsight study.

Khaled Awad, Raul Weiss, Asim Yunus, Jon M Bittrick, Rajasekhar Nekkanti, Mahmoud Houmsse, Toshimasa Okabe, Teagan Adamson, Crystal Miller, Abdul K Alawwa,

BACKGROUND:Insertable cardiac monitors are utilized for the diagnosis of arrhythmias and traditionally have been inserted within hospitals. Recent code updates allow for reimbursement of office-based insertions; however, there is limited information regarding the resources and processes required to support in-office insertions. We sought to determine the safety and feasibility of ... Read more >>

BMC Cardiovasc Disord (BMC cardiovascular disorders)
[2020, 20(1):171]

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Approaches to Minimizing Periprocedural Complications During Subcutaneous Implantable Cardioverter-defibrillator Placement.

Srikanth Vedachalam, Schuyler Cook, Tanner Koppert, Toshimasa Okabe, Raul Weiss, Muhammad R Afzal,

The subcutaneous implantable cardioverter-defibrillator (S-ICD) is the latest option among devices clinically available for the prevention of sudden cardiac death, with experience from previous trials and postmarketing studies supporting the feasibility and safety of this kind of system. The extracardiac positioning of the S-ICD obviates the need for transvenous leads, ... Read more >>

J Innov Card Rhythm Manag (The Journal of innovations in cardiac rhythm management)
[2020, 11(5):4100-4105]

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Risk Versus Benefit of Combined Aspirin and Warfarin Therapy in Patients With Atrial Fibrillation.

Tara A Nagaraj, Melissa J Snider, Erica Davidson, Raul Weiss, Junan Li, Muhammad Afzal,

<h4>Purpose</h4>Guidelines have differing recommendations for aspirin use in patients with an indication for anticoagulation. The purpose of this study was to evaluate the incidence of major bleeding and thromboembolic events (TEs) in patients with atrial fibrillation (AF) receiving warfarin alone (monotherapy group) versus warfarin plus aspirin (combination therapy group).<h4>Methods</h4>This was ... Read more >>

J Pharm Pract (Journal of pharmacy practice)
[2021, 34(5):766-773]

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Diagnosis and management of subcutaneous implantable cardioverter-defibrillator infections based on process mapping.

Larry M Baddour, Raul Weiss, George E Mark, Mikhael F El-Chami, Mauro Biffi, Vincent Probst, Pier D Lambiase, Marc A Miller, Timothy McClernon, Linda K Hansen, Bradley P Knight,

<h4>Background</h4>Infection is a well-recognized complication of cardiovascular implantable electronic device (CIED) implantation, including the more recently available subcutaneous implantable cardioverter-defibrillator (S-ICD). Although the AHA/ACC/HRS guidelines include recommendations for S-ICD use, currently there are no clinical trial data that address the diagnosis and management of S-ICD infections. Therefore, an expert panel ... Read more >>

Pacing Clin Electrophysiol (Pacing and clinical electrophysiology : PACE)
[2020, 43(9):958-965]

Cited: 1 time

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