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Author Suneet Mittal

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Risk Factors for CIED Infection After Secondary Procedures: Insights From the WRAP-IT Trial.

Khaldoun G Tarakji, Andrew D Krahn, Jeanne E Poole, Suneet Mittal, Charles Kennergren, Mauro Biffi, Panagiotis Korantzopoulos, Paolo Domenico Dallaglio, Daniel R Lexcen, Jeff D Lande, Gregory Hilleren, Reece Holbrook, Bruce L Wilkoff,

<h4>Objectives</h4>This study aimed to identify risk factors for infection after secondary cardiac implantable electronic device (CIED) procedures.<h4>Background</h4>Risk factors for CIED infection are not well defined and techniques to minimize infection lack supportive evidence. WRAP-IT (World-wide Randomized Antibiotic Envelope Infection Prevention trial), a large study that assessed the safety and efficacy ... Read more >>

JACC Clin Electrophysiol (JACC. Clinical electrophysiology)
[2021, :]

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Device-Based Arrhythmia Monitoring.

Suneet Mittal, David J Slotwiner,

Card Electrophysiol Clin (Cardiac electrophysiology clinics)
[2021, 13(3):xv-xvi]

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Performance of first pacemaker to use smart device app for remote monitoring

Khaldoun G. Tarakji, Amir M. Zaidi, Steven L. Zweibel, Niraj Varma, Samuel F. Sears, James Allred, Paul R. Roberts, Naushad A. Shaik, Josh R. Silverstein, Abdul Maher, Suneet Mittal, Ashish Patwala, John Schoenhard, Martin Emert, Giulio Molon, Giuseppe Augello, Nilam Patel, Hanscy Seide, Antonio Porfilio, Baerbel Maus, Sherry L. Di Jorio, Keith Holloman, Ana C. Natera, Mintu P. Turakhia,

<h4>Background</h4> High adherence to remote monitoring (RM) in pacemaker (PM) patients improves outcomes; however, adherence remains suboptimal. Bluetooth low-energy (BLE) technology in newer-generation PMs enables communication directly with patient-owned smart devices using an app without a bedside console. <h4>Objective</h4> To evaluate the success rate of scheduled RM transmissions using the ... Read more >>

Heart Rhythm O2 (Heart rhythm O2)
[2021, 2(5):463-471]

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Implantable Loop Recorders-Syncope, Cryptogenic Stroke, Atrial Fibrillation.

Suneet Mittal,

The implantable loop recorder (ILR) is a subcutaneous, single-lead, electrocardiographic (ECG) monitoring device used for diagnosis in patients with recurrent, unexplained episodes of palpitations or syncope, for long-term monitoring in patients at risk for atrial fibrillation (AF), and to guide clinical management in patients with known AF. These devices are ... Read more >>

Card Electrophysiol Clin (Cardiac electrophysiology clinics)
[2021, 13(3):439-447]

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Reply: Evaluating the Use of AI in Implantable Loop Recorders for AF Detection.

Suneet Mittal, Christine Henry, Christophe Gardella,

JACC Clin Electrophysiol (JACC. Clinical electrophysiology)
[2021, 7(8):1069-1070]

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Lipoprotein(a) and Benefit of PCSK9 Inhibition in Patients With Nominally Controlled LDL Cholesterol.

Gregory G Schwartz, Michael Szarek, Vera A Bittner, Rafael Diaz, Shaun G Goodman, J Wouter Jukema, Ulf Landmesser, Patricio López-Jaramillo, Garen Manvelian, Robert Pordy, Michel Scemama, Peter R Sinnaeve, Harvey D White, Ph Gabriel Steg, ,

<h4>Background</h4>Guidelines recommend nonstatin lipid-lowering agents in patients at very high risk for major adverse cardiovascular events (MACE) if low-density lipoprotein cholesterol (LDL-C) remains ≥70 mg/dL on maximum tolerated statin treatment. It is uncertain if this approach benefits patients with LDL-C near 70 mg/dL. Lipoprotein(a) levels may influence residual risk.<h4>Objectives</h4>In a post hoc analysis ... Read more >>

J Am Coll Cardiol (Journal of the American College of Cardiology)
[2021, 78(5):421-433]

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Infectious consequences of hematoma from cardiac implantable electronic device procedures and the role of the antibiotic envelope: A WRAP-IT trial analysis.

Khaldoun G Tarakji, Panagiotis Korantzopoulos, Francois Philippon, Mauro Biffi, Suneet Mittal, Jeanne E Poole, Charles Kennergren, Daniel R Lexcen, Jeff D Lande, Swathi Seshadri, Bruce L Wilkoff,

<h4>Background</h4>Hematoma is a complication of cardiac implantable electronic device (CIED) procedures and may lead to device infection. The TYRX antibacterial envelope reduced major CIED infection by 40% in the randomized WRAP-IT (World-wide Randomized Antibiotic Envelope Infection Prevention Trial) study, but its effectiveness in the presence of hematoma is not well ... Read more >>

Heart Rhythm (Heart rhythm)
[2021, :]

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A novel adaptive insertable cardiac monitor algorithm improves the detection of atrial fibrillation and atrial tachycardia in silico.

Sunipa Saha, David Perschbacher, Paul Jones, Kate Frost, Arjun Sharma, Suneet Mittal, Mark Richards,

<h4>Introduction</h4>Insertable cardiac monitors (ICMs) provide a minimally invasive method of continuous monitoring for abnormal heart rhythms. While the benefits of ICMs are clear, current algorithm performance can be improved. The objective of this study is to assess the performance of a novel adaptive atrial fibrillation (AF) detection algorithm and separately ... Read more >>

J Cardiovasc Electrophysiol (Journal of cardiovascular electrophysiology)
[2021, 32(9):2536-2543]

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The problematic lag between FDA approval of medical devices and CMS coverage.

Bradley P Knight, Thomas F Deering, Michael R Gold, Suneet Mittal, Jagmeet P Singh,

J Cardiovasc Electrophysiol (Journal of cardiovascular electrophysiology)
[2021, 32(7):1801-1802]

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The Problematic Lag between FDA Approval of Medical Devices and CMS Coverage

Bradley Knight, Thomas Deering, Michael Gold, Suneet Mittal, Jagmeet Singh,

Significant changes or cancellation of MCIT could result in limiting access to breakthrough medical technologies that could improve the health and well-being of Medicare beneficiaries. For these reasons, we encourage federal agencies to work together and CMS to implement the MCIT rule without delay to ensure timely access to breakthrough ... Read more >>

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Ambulatory Electrocardiogram Monitoring in Patients Undergoing Transcatheter Aortic Valve Replacement: JACC State-of-the-Art Review.

Guillem Muntané-Carol, François Philippon, Isabelle Nault, Laurent Faroux, Alberto Alperi, Suneet Mittal, Josep Rodés-Cabau,

Transcatheter aortic valve replacement (TAVR) has changed the treatment of patients with severe aortic stenosis. However, the occurrence of conduction disturbances has not decreased significantly over time and remains the main drawback of the procedure. In addition, new-onset atrial fibrillation is the most frequent tachyarrhythmia during the hospitalization period and ... Read more >>

J Am Coll Cardiol (Journal of the American College of Cardiology)
[2021, 77(10):1344-1356]

Cited: 2 times

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Low-temperature electrocautery reduces adverse effects from secondary cardiac implantable electronic device procedures: Insights from the WRAP-IT trial.

Suneet Mittal, Bruce L Wilkoff, Jeanne E Poole, Charles Kennergren, David J Wright, Brett J Berman, David Riggio, Darius P Sholevar, Joaquin Martinez-Arraras, Jean B Moubarak, Robert D Schaller, John C Love, Robert A Pickett, Francois Philippon, Zayd Eldadah, Jeffrey D Lande, Daniel R Lexcen, Reece Holbrook, Khaldoun G Tarakji,

<h4>Background</h4>Cardiac device procedures require tissue dissection to free existing device lead(s). Common techniques include blunt dissection, standard electrocautery, and low-temperature electrocautery (PlasmaBlade, Medtronic); however, data on the type of electrosurgical tool used and the development of procedure- or lead-related adverse events are limited.<h4>Objective</h4>The purpose of this study was to determine ... Read more >>

Heart Rhythm (Heart rhythm)
[2021, 18(7):1142-1150]

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AI Filter Improves Positive Predictive Value of Atrial Fibrillation Detection by an Implantable Loop Recorder.

Suneet Mittal, Susan Oliveros, Jia Li, Thibaut Barroyer, Christine Henry, Christophe Gardella,

<h4>Objectives</h4>The purpose of this study was to determine whether incorporation of a 2-part artificial intelligence (AI) filter can improve the positive predictive value (PPV) of implantable loop recorder (ILR)-detected atrial fibrillation (AF) episodes.<h4>Background</h4>ILRs can detect AF. Devices transmit data daily. It is critical that the PPV of ILR-detected AF events ... Read more >>

JACC Clin Electrophysiol (JACC. Clinical electrophysiology)
[2021, 7(8):965-975]

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Cost-effectiveness of an insertable cardiac monitor to detect atrial fibrillation in patients with cryptogenic stroke.

Laura M Sawyer, Klaus K Witte, Matthew R Reynolds, Suneet Mittal, Frank W Grimsey Jones, Sarah C Rosemas, Paul D Ziegler, Rachelle E Kaplon, Shadi Yaghi,

<b>Background:</b> We assessed cost-effectiveness of insertable cardiac monitors (ICMs) in a US cryptogenic stroke population. <b>Materials & methods:</b> We modelled lifetime costs and quality-adjusted life years for three monitoring strategies post cryptogenic stroke: ICM starting immediately, ICM starting after Holter monitoring (delayed ICM) and standard of care involving intermittent ECG and Holter monitoring. ... Read more >>

J Comp Eff Res (Journal of comparative effectiveness research)
[2021, 10(2):127-141]

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Results from the prospective, multicenter AMBULATE-CAP trial: Reduced use of urinary catheters and protamine with hemostasis via the Mid-Bore Venous Vascular Closure System (VASCADE® MVP) following multi-access cardiac ablation procedures.

Amin Al-Ahmad, Suneet Mittal, David DeLurgio, G Joseph Gallinghouse, Rodney P Horton, Mark W Preminger, J David Burkhardt, Andrea Natale,

<h4>Introduction</h4>Manual compression (MC), historically the most common method to achieve hemostasis after percutaneous vascular procedures, is time consuming, requires prolonged bedrest, and is uncomfortable for patients and clinicians. Recent studies demonstrate the efficacy and safety of vascular closure devices and suggest shorter times to hemostasis and patient ambulation compared with ... Read more >>

J Cardiovasc Electrophysiol (Journal of cardiovascular electrophysiology)
[2021, 32(2):191-199]

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Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation.

Oussama M Wazni, Gopi Dandamudi, Nitesh Sood, Robert Hoyt, Jaret Tyler, Sarfraz Durrani, Mark Niebauer, Kevin Makati, Blair Halperin, Andre Gauri, Gustavo Morales, Mingyuan Shao, Jeffrey Cerkvenik, Rachelle E Kaplon, Steven E Nissen, ,

<h4>Background</h4>In patients with symptomatic paroxysmal atrial fibrillation that has not responded to medication, catheter ablation is more effective than antiarrhythmic drug therapy for maintaining sinus rhythm. However, the safety and efficacy of cryoballoon ablation as initial first-line therapy have not been established.<h4>Methods</h4>We performed a multicenter trial in which patients 18 ... Read more >>

N Engl J Med (The New England journal of medicine)
[2021, 384(4):316-324]

Cited: 24 times

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I Need a Pacemaker-What Are My Options?

Tina Sichrovsky, Suneet Mittal,

JAMA Cardiol (JAMA cardiology)
[2020, 5(12):1456]

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Clinical Presentation, Timing, and Microbiology of CIED Infections: An Analysis of the WRAP-IT Trial.

M Rizwan Sohail, G Ralph Corey, Bruce L Wilkoff, Jeanne E Poole, Suneet Mittal, Charles Kennergren, Arnold J Greenspon, Alan Cheng, Jeffrey D Lande, Daniel R Lexcen, Khaldoun G Tarakji,

<h4>Objectives</h4>This study characterized the microbiology of major cardiac implantable electronic device (CIED) infections that occurred during the WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) study.<h4>Background</h4>The WRAP-IT study offers a unique opportunity for further understanding of the pathogens involved in major CIED infections in a prospective dataset, with implications for ... Read more >>

JACC Clin Electrophysiol (JACC. Clinical electrophysiology)
[2021, 7(1):50-61]

Cited: 1 time

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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: 22 times

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Real-world performance of the atrial fibrillation monitor in patients with a subcutaneous ICD.

Sarah W E Baalman, Suneet Mittal, Lucas V A Boersma, Dave Perschbacher, Amy J Brisben, Deepa Mahajan, Joris R de Groot, Reinoud E Knops,

<h4>Introduction</h4>The third-generation subcutaneous implantable cardioverter-defibrillator (S-ICD) (EMBLEM™ A219, Boston Scientific) contains a new diagnostic tool to detect atrial fibrillation (AF) in S-ICD patients, without the use of an intracardiac lead. This is the first study to evaluate the performance of the S-ICD AF monitor (AFM).<h4>Methods</h4>The AFM algorithm analyzes a subcutaneous ... Read more >>

Pacing Clin Electrophysiol (Pacing and clinical electrophysiology : PACE)
[2020, 43(12):1467-1475]

Cited: 1 time

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Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial.

Bruce L Wilkoff, Giuseppe Boriani, Suneet Mittal, Jeanne E Poole, Charles Kennergren, G Ralph Corey, Andrew D Krahn, Edward J Schloss, Jose L Gallastegui, Robert A Pickett, Rudolph F Evonich, Steven F Roark, Denise M Sorrentino, Darius P Sholevar, Edmond M Cronin, Brett J Berman, David W Riggio, Hafiza H Khan, Marc T Silver, Jack Collier, Zayd Eldadah, Reece Holbrook, Jeff D Lande, Daniel R Lexcen, Swathi Seshadri, Khaldoun G Tarakji,

<h4>Background</h4>In the WRAP-IT trial (Worldwide Randomized Antibiotic Envelope Infection Prevention), adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device infection without increased risk of complication in 6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy ... Read more >>

Circ Arrhythm Electrophysiol (Circulation. Arrhythmia and electrophysiology)
[2020, 13(10):e008503]

Cited: 3 times

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Incidence and Predictors of Very Late Recurrence of Atrial Fibrillation Following Cryoballoon Pulmonary Vein Isolation.

Dan L Musat, Nicolle S Milstein, Advay Bhatt, Tina C Sichrovsky, Mark W Preminger, Carissa Pistilli, Michael Rozylowicz, Richard E Shaw, Suneet Mittal,

<h4>Background</h4>A very late recurrence (VLR) of atrial fibrillation (AF) is considered present when the first recurrence of AF occurs ≥12 months following ablation. Prior studies characterizing VLR have not used an implantable loop recorder for ECG monitoring. Thus, it is unknown whether VLR truly occurs or whether these patients have ... Read more >>

Circ Arrhythm Electrophysiol (Circulation. Arrhythmia and electrophysiology)
[2020, 13(9):e008646]

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The wearable cardioverter-defibrillator is not needed for most high-risk patients.

Advay G Bhatt, Suneet Mittal,

Heart Rhythm O2 (Heart rhythm O2)
[2020, 1(3):230-233]

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Left Bundle Branch Pacing: A Contender Emerges to Challenge the 25-Year Run of Cardiac Resynchronization Therapy.

Suneet Mittal, Advay G Bhatt,

JACC Clin Electrophysiol (JACC. Clinical electrophysiology)
[2020, 6(7):859-862]

Cited: 0 times

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Rationale, considerations, and goals for atrial fibrillation centers of excellence: A Heart Rhythm Society perspective.

Jonathan P Piccini, James Allred, T Jared Bunch, Thomas F Deering, Luigi Di Biase, Ayman A Hussein, William R Lewis, Suneet Mittal, Andrea Natale, Jose Osorio, Douglas L Packer, Christian Ruff, Andrea M Russo, Prashanthan Sanders, Amber Seiler, David Slotwiner, Mellanie True Hills, Mintu P Turakhia, Isabelle C Van Gelder, Paul D Varosy, Atul Verma, Annabelle S Volgman, Kathryn A Wood, Thomas Deneke,

Heart Rhythm (Heart rhythm)
[2020, 17(10):1804-1832]

Cited: 2 times

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