89 results on '"El‐Chami, Mikhael"'
Search Results
2. Same day discharge after transvenous lead extraction: Balancing safety and efficiency.
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El‐Chami, Mikhael F.
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ELECTIVE surgery , *CARDIAC surgery , *MEDICAL device removal , *SOCIAL support , *SERIAL publications , *IMPLANTABLE cardioverter-defibrillators , *POSTOPERATIVE care , *TREATMENT effectiveness , *MEDICAL care use , *POSTOPERATIVE period , *AMBULATORY surgery , *DISCHARGE planning , *PATIENT safety - Abstract
An editorial is presented which discusses the shift towards same-day discharge (SDD) after various cardiac procedures, including percutaneous coronary intervention (PCI) and cardiac implantable electronic device (CIED) implantation. The article explores the safety and benefits of SDD after transvenous lead extraction (TLE), highlighting factors such as noninfectious indications, early procedure times, good social support, and physician judgment aligning with patient decision.
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- 2024
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3. Device‐related infection associated with increased mortality risk in de novo transvenous implantable cardioverter‐defibrillator medicare patients.
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El‐Chami, Mikhael F., Liu, Yiyan, Griffiths, Robert I., Knight, Bradley P., Weiss, Raul, Mark, George E., Biffi, Mauro, Probst, Vincent, Lambiase, Pier D., Miller, Marc A., Jacobsen, Caroline M., and Baddour, Larry M.
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FEE for service (Medical fees) , *NOSOLOGY , *CONFIDENCE intervals , *CATHETER ablation , *IMPLANTABLE cardioverter-defibrillators , *INFECTION , *RISK assessment , *SURVIVAL analysis (Biometry) , *COMPLICATIONS of prosthesis , *MEDICARE ,MORTALITY risk factors - Abstract
Introduction: Transvenous implantable cardioverter‐defibrillators (TV‐ICD) infection is a serious complication that frequently requires complete device removal for attempted cure, which can be associated with patient morbidity and mortality. The objective of this study is to assess mortality risk associated with TV‐ICD infection in a large Medicare population with de novo TV‐ICD implants. Methods: A survival analysis was conducted using 100% fee‐for‐service Medicare facility‐level claims data to identify patients who underwent de novo TV‐ICD implantation between 7/2016 and 1/2018. TV‐ICD infection within 2 years of implantation was identified using International Classification of Disease, 10th Edition and current procedural terminology codes. Baseline patient risk factors associated with mortality were identified using the Charlson Comorbidity Index categories. Infection was treated as a time‐dependent variable in a multivariate Cox proportional hazards model to account for immortal time bias. Results: Among 26,742 Medicare patients with de novo TV‐ICD, 518 (1.9%) had a device‐related infection. The overall number of decedents was 4721 (17.7%) over 2 years, with 4555 (17%) in the noninfection group and 166 (32%) in the infection group. After adjusting for baseline patient demographic characteristics and various comorbidities, the presence of TV‐ICD infection was associated with an increase of 2.4 (95% CI: 2.08–2.85) times in the mortality hazard ratio. Conclusion: The rate of TV‐ICD infection and associated mortality in a large, real‐world Medicare population is noteworthy. The positive association between device‐related infection and risk of mortality further highlights the need to reduce infections [ABSTRACT FROM AUTHOR]
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- 2022
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4. Outcomes of two versus three incision techniques: Results from the subcutaneous ICD post‐approval study.
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El‐Chami, Mikhael, Weiss, Raul, Burke, Martin C., Gold, Michael R., Prutkin, Jordan M., Kalahasty, Gautham, Shen, Sharon, Mirro, Michael J., Carter, Nathan, and Aasbo, Johan D.
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EVALUATION of medical care , *OPERATIVE surgery , *IMPLANTABLE cardioverter-defibrillators , *SOCIOECONOMIC factors , *TREATMENT effectiveness , *VENTRICULAR arrhythmia , *DESCRIPTIVE statistics , *STATISTICAL sampling , *PATIENT safety , *LONGITUDINAL method , *COMORBIDITY - Abstract
Background: 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. Objectives: To report on the long‐term safety and efficacy of the 2IT compared to the 3IT procedure in a large patient cohort. Methods: Patients enrolled in the S‐ICD post approval study (PAS) were stratified by procedural technique (2IT vs. 3IT). Baseline demographics, comorbidities and procedural outcomes were collected. Complications and S‐ICD effectiveness in treating ventricular arrhythmias through an average 3‐year follow‐up period were compared. Results: Of 1637 patients enrolled in the S‐ICD PAS, 854 pts (52.2%) were implanted using the 2IT and 782 were implanted using the 3IT (47.8%). The 2IT became more prevalent over time, increasing from 40% to 69% of implants (Q1–Q4). Mean procedure time was shorter with 2IT (69.0 vs. 86.3 min, p <.0001). No other differences in outcomes were observed between the two groups, including rates of infection, electrode migration, inappropriate shocks and first shock efficacy for treating ventricular arrhythmias. Conclusion: In this large cohort of patients implanted with an S‐ICD and followed for 3 years the 2IT was as safe and effective as the 3IT while significantly reducing procedure time. [ABSTRACT FROM AUTHOR]
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- 2021
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5. Leadless pacemaker implant with concomitant atrioventricular node ablation: Experience with the Micra transcatheter pacemaker.
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El‐Chami, Mikhael F., Shinn, Timothy, Bansal, Sundeep, Martinez‐Sande, Jose L., Clementy, Nicolas, Augostini, Ralph, Ravindran, Bipin, Sagi, Venkata, Ramanna, Hemanth, Garweg, Christophe, Roberts, Paul R., Soejima, Kyoko, Stromberg, Kurt, Fagan, Dedra H., Zuniga, Nicky, and Piccini, Jonathan P.
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ATRIOVENTRICULAR node , *SCIENTIFIC observation , *CONFIDENCE intervals , *ATRIAL fibrillation , *CATHETER ablation , *SURGERY , *PATIENTS , *TREATMENT effectiveness , *COMPARATIVE studies , *DESCRIPTIVE statistics , *REOPERATION , *CARDIAC pacemakers , *LONGITUDINAL method , *COMORBIDITY , *EVALUATION ,SURGICAL complication risk factors - Abstract
Background: The feasibility and outcomes of concomitant atrioventricular node ablation (AVNA) and leadless pacemaker implant are not well studied. We report outcomes in patients undergoing Micra implant with concomitant AVNA. Methods: Patients undergoing AVNA at the time of Micra implant from the Micra Transcatheter Pacing (IDE) Study, Continued Access (CA) study, and Post‐Approval Registry (PAR) were included in the analysis and compared to Micra patients without AVNA. Baseline characteristics, acute and follow‐up outcomes, and electrical performance were compared between patients with and without AVNA during the follow‐up period. Results: A total of 192 patients (mean age 77.4 ± 8.9 years, 72% female) underwent AVNA at the time of Micra implant and were followed for 20.4 ± 15.6 months. AVNA patients were older, more frequently female, and tended to have more co‐morbid conditions compared with non‐AVNA patients (N = 2616). Implant was successful in 191 of 192 patients (99.5%). The mean pacing threshold at implant was 0.58 ± 0.35 V and remained stable during follow‐up. Major complications within 30 days occurred more frequently in AVNA patients than non‐AVNA patients (7.3% vs. 2.0%, p <.001). The risk of major complications through 36‐months was higher in AVNA patients (hazard ratio: 3.81, 95% confidence interval: 2.33–6.23, p <.001). Intermittent loss of capture occurred in three AVNA patients (1.6%), all were within 30 days of implant and required system revision. There were no device macrodislodgements or unexpected device malfunctions. Conclusion: Concomitant AVN ablation and leadless pacemaker implant is feasible. Pacing thresholds are stable over time. However, patient comorbidities and the risk of major complications are higher in patients undergoing AVNA. [ABSTRACT FROM AUTHOR]
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- 2021
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6. Atrio‐ventricular synchronous pacing with a single chamber leadless pacemaker: Programming and trouble shooting for common clinical scenarios.
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El‐Chami, Mikhael F., Bhatia, Neal K., and Merchant, Faisal M.
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ALGORITHMS , *CARDIAC pacemakers , *CARDIAC pacing , *HEART atrium , *CASE studies , *NARRATIVE medicine - Abstract
Micra leadless pacemaker has progressed from a single chamber pacemaker that can deliver VVIR pacing to a pacing device that can provide atrio‐ventricular (AV) synchrony via a unique pacing algorithm that relies on identifying mechanical atrial contraction. This novel algorithm has its own limitations and intricacies. In this paper, we review this algorithm, suggest steps for troubleshooting and programming these devices and provide clinical examples of Micra AV cases that required changes in programming for adequate tracking of atrial activity. [ABSTRACT FROM AUTHOR]
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- 2021
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7. Reduced bacterial adhesion with parylene coating: Potential implications for Micra transcatheter pacemakers.
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El‐Chami, Mikhael F., Mayotte, Jane, Bonner, Matt, Holbrook, Reece, Stromberg, Kurt, and Sohail, Muhammad Rizwan
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BACTERIAL physiology , *BACTERIAL growth , *CARDIAC pacemakers , *MICROBIOLOGICAL techniques , *POLYMERS , *POLYURETHANES , *PSEUDOMONAS , *STAPHYLOCOCCUS aureus , *DESCRIPTIVE statistics , *MEDICAL equipment contamination , *COLONY-forming units assay , *PREVENTION - Abstract
Introduction: Infections of cardiac implantable electronic devices remain a prevalent health concern necessitating the advent of novel preventative strategies. Based on the observation that bacterial infections of the Micra transcatheter pacemaker device are extremely rare, we examine the effect of parylene coating on bacterial adhesion and growth. Methods: Bacterial growth was compared on polyurethane coated, bare, or parylene coated titanium surfaces. Eight test samples per bacterial species and material combination were incubated with Staphylococcus Aureus or Pseudomonas aeruginosa for 24 hours and then assayed for bacterial growth. The surface contact angle was also characterized by measuring the angle between the tangent to the surface of a liquid droplet made with the surface of the solid sample. Results: The mean bacterial colony counts were significantly reduced for both parylene coated titanium versus bare samples (3.69 ± 0.27 and 4.80 ± 0.48 log[CFU/mL] respectively for S. aureus [P <.001] and 5.51 ± 0.27 and 6.08 ± 0.11 log[CFU/mL] respectively for P. aeruginosa [P <.001]), and for parylene coated titanium versus polyurethane samples (4.27 ± 0.42 and 5.40 ± 0.49 log[CFU/mL] respectively for S. aureus [P <.001] and 4.23 ± 0.42 and 4.84 ± 0.32 log[CFU/mL] respectively for P. aeruginosa [P =.006]). Parylene coated titanium samples had a higher contact angle compared with bare titanium, but lower compared with polyurethane (mean contact angle 87.5 ± 3.1 degrees parylene, 73.3 ± 3.7 degrees titanium [P <.001 vs parylene], and 94.8 ± 3.7 degrees polyurethane [P =.002 vs parylene]). Conclusions: Parylene coating significantly reduced the ability of bacteria to grow in colony count assays suggesting that this could contribute to the reduction of bacterial infections of Micra transcatheter pacemakers. [ABSTRACT FROM AUTHOR]
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- 2020
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8. Femoral extraction of transvenous leads and leadless pacemakers—A review of the data, tools, and procedural steps.
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El‐Chami, Mikhael F. and Merchant, Faisal M.
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BLOOD vessels , *CARDIAC pacemakers , *CLINICAL competence , *ELECTRODES , *FEMORAL vein , *MEDICAL equipment , *MEDICAL device removal - Abstract
Extraction of transvenous leads via the femoral route might be needed when extraction via the implant vein fails or when retained lead fragments exist. The skill set required for this procedure is unique as it relies on the ability to snare and the use of a variety of shelf tools. In this era of leadless pacing, this skill set might be called upon more frequently. In this article, we review the data, tools, and procedural steps of femoral lead extraction and retrieval/extraction of leadless pacemakers. [ABSTRACT FROM AUTHOR]
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- 2019
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9. Incidence and outcomes of systemic infections in patients with leadless pacemakers: Data from the Micra IDE study.
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El‐Chami, Mikhael F., Soejima, Kyoko, Piccini, Jonathan P., Reynolds, Dwight, Ritter, Philippe, Okabe, Toshimasa, Friedman, Paul A., Cha, Yong‐Mei, Stromberg, Kurt, Holbrook, Reece, Fagan, Dedra H., and Roberts, Paul R.
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ANTIBIOTICS , *INFECTION risk factors , *ENDOCARDITIS , *BACTEREMIA , *CARDIAC pacemakers , *ENTEROCOCCUS , *GRAM-negative bacteria , *GRAM-positive bacteria , *INFECTION , *COMPLICATIONS of prosthesis , *RISK assessment , *STAPHYLOCOCCUS , *STREPTOCOCCUS , *DISEASE incidence , *DISEASE risk factors ,RISK of prosthesis complications - Abstract
Background: The Micra clinical trials have enrolled more than 2500 patients without any reported device‐related infections that required removal during follow‐up. Leadless pacemakers might be more resistant to bacterial seeding due to smaller surface area and a greater tendency for encapsulation. Objective: To analyze the incidence and outcomes of serious infectious events (SIEs: bacteremia or endocarditis) that developed during follow‐up in patients with history of Micra leadless pacemaker implantation. Methods: SIE and outcomes were characterized based upon adverse event reports. Among 720 patients implanted with Micra in the investigational device exemption trial, we identified 16 patients who had documented 21 SIEs during follow‐up. Results: Among patients with SIEs, mean age was 71.9 ± 11.7 years. SIEs occurred at a mean 4.8 ± 4.5 months after implant and patients were followed for 13.1 ± 9.1 months after documentation of SIE. All events were adjudicated as unrelated to the Micra device or procedure. Bacteremia was documented to be related to a gram‐positive organism in 13 events (seven Staphylococcus, three Streptococcus, two Enterococcus, and one uncharacterized gram‐positive bacteria), and gram‐negative organisms in three events. In five events, the type of organism was not characterized (two patients with endocarditis). No persistent cases of bacteremia after antibiotic cessation were seen over the duration of follow‐up Conclusion: In this small series of Micra patients who developed SIEs postimplant, the occurrence of bacteremia and/or endocarditis did not appear to lead to persistent bacteremia off antibiotics; most events resolved with antibiotic treatment. [ABSTRACT FROM AUTHOR]
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- 2019
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10. Leadless pacemaker implant in patients with pre‐existing infections: Results from the Micra postapproval registry.
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El‐Chami, Mikhael F., Roberts, Paul R., Soejima, Kyoko, Stromberg, Kurt, Piccini, Jonathan P., Johansen, Jens Brock, Zaidi, Amir, Faerestrand, Svein, Reynolds, Dwight, Garcia‐Seara, Javier, Mansourati, Jacques, Pasquie, Jean‐Luc, and McElderry, Hugh Thomas
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INFECTION prevention , *ANTIBIOTICS , *CARDIAC pacemakers , *CARDIAC pacing , *DEATH , *ELECTRODES , *LENGTH of stay in hospitals , *ARTIFICIAL implants , *PATIENT safety , *SEPSIS , *TREATMENT effectiveness , *MEDICAL device removal , *DESCRIPTIVE statistics , *MEDICAL implant registries , *DISEASE complications , *EQUIPMENT & supplies - Abstract
Introduction: Leadless pacemakers may provide a safe and attractive pacing option to patients with cardiac implantable electronic device (CIED) infection. We describe the characteristics and outcomes of patients with a recent CIED infection undergoing Micra implant attempt. Methods and Results: Patients with prior CIED infection and device explant with Micra implant within 30 days, were identified from the Micra post approval registry. Procedure characteristics and outcomes were summarized. A total of 105 patients with prior CIED infection underwent Micra implant attempt ≤30 days from prior system explant (84 [80%] pacemakers and 13 [12%] ICD/CRT‐D). All system components were explanted in 93% of patients and explant occurred a median of 6 days before Micra implant, with 37% occurring on the day of Micra implant. Micra was successfully implanted in 99% patients, mean follow‐up duration was 8.5 ± 7.1 months (range 0‐28.5). The majority of patients (91%) received IV antibiotics preimplant, while 42% of patients received IV antibiotics postprocedure. The median length of hospitalization following Micra implant was 2 days (IQR, 1‐7). During follow‐up, two patients died from sepsis and four patients required system upgrade, of which two patients received Micra to provide temporary pacing support. There were no Micra devices explanted due to infection. Conclusion: Implantation of the Micra transcatheter pacemaker is safe and feasible in patients with a recent CIED infection. No recurrent infections that required Micra device removal were seen. Leadless pacemakers appear to be a safe pacing alternative for patients with CIED infection who undergo extraction. [ABSTRACT FROM AUTHOR]
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- 2019
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11. Leadless pacemaker implantation and concurrent atrioventricular junction ablation in patients with atrial fibrillation.
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Okabe, Toshimasa, El‐Chami, Mikhael F., Lloyd, Michael S., Buck, Benjamin, Gornick, Charles C., Moore, JoEllyn C., Augostini, Ralph S., and Hummel, John D.
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ATRIOVENTRICULAR node , *ATRIAL fibrillation , *CARDIAC pacemakers , *CATHETER ablation , *PATIENT aftercare , *TIME , *TREATMENT effectiveness , *RETROSPECTIVE studies , *SURGERY - Abstract
Background: Atrioventricular junctional (AVJ) ablation and pacemaker implantation are indicated when pharmacotherapy fails to achieve adequate rate control in atrial fibrillation (AF). The purpose of our study is to assess the feasibility and safety of concurrent Micra leadless transcatheter pacemaker implantation and AVJ ablation. Methods:We retrospectively assessed patients who underwent Micra implantation and concurrent AVJ ablation at three institutions between August 2014 and March 2016. All patients and devices were followed at baseline and at 1, 3, 6, and 12months postimplantion. Results: Twenty-one patients with permanent AF (median age 77 [range: 62-88], female 15 [71.4%]) underwent successful Micra implantation followed by concurrent AVJ ablation. There was no device dislodgement or malfunction during the 12-month follow-up. Complete 12-month electrical performance data were available in 14 patients (67%). Among patients with the complete data set, median pacing thresholds at implant and at 1, 3, 6, and 12months were 0.5V(range: 0.25-0.88), 0.44 V (range: 0.25-2.0), 0.5 V (range: 0.25-1.63), 0.5 V (range: 0.25-1.13), and 0.5 V (range: 0.25-1.13) at a pulse width of 0.24 msec, respectively. Two patients died due to noncardiac causes during follow-up. There were no patients with major device-related complications. Conclusions: Concurrent Micra implantation and AVJ ablation is feasible and appears safe. There was no device dislodgement, malfunction, or significant pacing threshold rise requiring device reimplantation during the 12-month follow-up. This combined approach can be considered for patients with AF with suboptimal rate control who have failed AF catheter ablation and/or pharmacotherapy. [ABSTRACT FROM AUTHOR]
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- 2018
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12. Impact of operator experience and training strategy on procedural outcomes with leadless pacing: Insights from the Micra Transcatheter Pacing Study.
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El‐Chami, Mikhael, Kowal, Robert C., Soejima, Kyoko, Ritter, Philippe, Duray, Gabor Z., Neuzil, Petr, Mont, Lluis, Kypta, Alexander, Sagi, Venkata, Hudnall, John Harrison, Stromberg, Kurt, and Reynolds, Dwight
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BIOLOGICAL models , *CARDIAC pacing , *CATHETER ablation , *DEAD , *ENDOSCOPIC surgery , *LEARNING strategies , *EVALUATION of medical care , *WORK experience (Employment) - Abstract
Background Leadless pacemaker systems have been designed to avoid the need for a pocket and transvenous lead. However, delivery of this therapy requires a new catheter-based procedure. This study evaluates the role of operator experience and different training strategies on procedural outcomes. Methods A total of 726 patients underwent implant attempt with the Micra transcatheter pacing system (TPS; Medtronic, Minneapolis, MN, USA) by 94 operators trained in a teaching laboratory using a simulator, cadaver, and large animal models (lab training) or locally at the hospital with simulator/demo model and proctorship (hospital training). Procedure success, procedure duration, fluoroscopy time, and safety outcomes were compared between training methods and experience (implant case number). Results The Micra TPS procedure was successful in 99.2% of attempts and did not differ between the 55 operators trained in the lab setting and the 39 operators trained locally at the hospital (P = 0.189). Implant case number was also not a determinant of procedural success (P = 0.456). Each operator performed between one and 55 procedures. Procedure time and fluoroscopy duration decreased by 2.0% (P = 0.002) and 3.2% (P < 0.001) compared to the previous case. Major complication rate and pericardial effusion rate were not associated with case number (P = 0.755 and P = 0.620, respectively). There were no differences in the safety outcomes by training method. Conclusions Among a large group of operators, implantation success was high regardless of experience. While procedure duration and fluoroscopy times decreased with implant number, complications were low and not associated with case number. Procedure and safety outcomes were similar between distinct training methodologies. [ABSTRACT FROM AUTHOR]
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- 2017
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13. Procedural outcomes and long-term survival following lead extraction in octogenarians.
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El‐Chami, Mikhael F., Sayegh, Michael N., Patel, Adarsh, El‐Khalil, Jad, Desai, Yaanik, Leon, Angel R., and Merchant, Faisal M.
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EVALUATION of medical care , *CARDIAC pacemakers , *DEFIBRILLATORS , *LEAD , *HEALTH outcome assessment , *SURVIVAL , *TIME , *RETROSPECTIVE studies , *EVALUATION - Abstract
Background Octogenarians account for a significant percentage of patients with indwelling pacemakers or defibrillators. Objectives To determine procedural outcomes and long-term survival after lead extraction (LE) in octogenarians. Methods We retrospectively identified all patients who underwent defibrillator or pacemaker LE at our institution between January 1, 2007 and May 31, 2016. Patients were stratified based on age into two groups: <80 years old (Group 1, n = 674) or ≥80 (Group 2, n = 100). Outcomes were determined by medical records review and query of the Social Security Death Index. Results Patients in Group 2 were more likely to be hypertensive (77% vs 61%, P = 0.02), more like to have coronary artery disease (50% vs 39%, P = 0.049), and more likely to be extracted for infectious indications (47% vs 33%, P = .009). The number of leads extracted per procedure was 2.0 ± 0.8 and the mean dwell time of the oldest extracted lead was 5.6 ± 4.3 years, without significant differences between groups. Extraction procedure success (Group 1: 94.7%, Group 2: 96%, P = 0.808) and procedural deaths (Group 1: 0.9% vs Group 2: 0%, P = 1.0) were similar. There was no significant difference in survival up to 3 years following LE between groups. Conclusion At experienced centers, LE can be performed safely in octogenarians with procedural success rates and long-term survival comparable to younger individuals. [ABSTRACT FROM AUTHOR]
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- 2017
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14. Management of Atrial Fibrillation in Elderly Adults.
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Desai, Yaanik, El‐Chami, Mikhael F., Leon, Angel R., and Merchant, Faisal M.
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ATRIAL fibrillation treatment , *STROKE prevention , *CEREBRAL hemorrhage , *DRUG therapy , *WARFARIN , *LEFT heart atrium , *ANTICOAGULANTS , *ATRIAL fibrillation , *CATHETER ablation , *ORAL drug administration , *DISEASE complications , *SYMPTOMS , *OLD age , *SURGERY , *DISEASE risk factors ,STROKE risk factors - Abstract
Driven in large part by the aging of the population and the increasing prevalence of cardiovascular comorbidities associated with atrial fibrillation ( AF), there is a burgeoning epidemic of AF in elderly adults. Although there is a large body of literature to guide management of people with AF, elderly adults with AF are frequently underrepresented in clinical trials. This review provides a contemporary update on management of elderly adults with AF with a particular focus on the two main clinical challenges that AF poses: stroke risk reduction and control of symptoms. The evidence to support novel AF treatment strategies in elderly adults is reviewed, including novel oral anticoagulants and left atrial appendage closure for stroke risk reduction and catheter ablation for control of symptoms. [ABSTRACT FROM AUTHOR]
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- 2017
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15. How to Implant a Leadless Pacemaker With a Tine-Based Fixation.
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EL‐CHAMI, MIKHAEL F., ROBERTS, PAUL R., KYPTA, ALEX, OMDAHL, PAMELA, BONNER, MATTHEW D., KOWAL, ROBERT C., and DURAY, GABOR Z.
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CARDIAC pacemakers , *MEDICAL equipment , *TECHNOLOGY , *NEW product development laws - Abstract
Leadless Implant Procedure Two major studies have shown that leadless pacemakers are safe and effective for patients requiring right ventricular rate responsive pacing therapy. This positive result recently led to FDA approval of one of the available leadless pacing devices. While this new technology is promising, it requires a different skill set for safe implantation. In this article, we review in detail the different steps required for implantation of tine-based leadless pacemakers while providing tips and tricks to minimize complications. [ABSTRACT FROM AUTHOR]
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- 2016
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16. Management of New-Onset Postoperative Atrial Fibrillation Utilizing Insertable Cardiac Monitor Technology to Observe Recurrence of AF (MONITOR-AF).
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EL‐CHAMI, MIKHAEL F., MERCHANT, FAISAL M., SMITH, PAIGE, LEVY, MATHEW, NELMS, ANGELA GILL, MERLINO, JOHN, PUSKAS, JOHN, and LEON, ANGEL R.
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ACADEMIC medical centers , *AMBULATORY electrocardiography , *ATRIAL fibrillation , *INFLAMMATION , *LONGITUDINAL method , *PERICARDIUM , *PROBABILITY theory , *RESEARCH funding , *PHYSIOLOGICAL stress , *SURGICAL complications , *T-test (Statistics) , *DISEASE management , *DISEASE relapse , *DATA analysis software , *DESCRIPTIVE statistics , *KAPLAN-Meier estimator - Abstract
Background New-onset postoperative atrial fibrillation (POAF) occurs in up to 30% of patients undergoing coronary artery bypass grafting (CABG). POAF is associated with short- and long-term mortality. Methods To identify the true incidence and time course of recurrent atrial fibrillation (AF) in patients with POAF, we prospectively assigned 23 patients with POAF to receive an implantable loop recorder (ILR; Medtronic Inc., Minneapolis, MN, USA) for the detection of recurrent AF. Two electrophysiologists independently adjudicated monthly ILR transmissions to classify recurrent AF. We defined AF as any episode lasting ≥6 minutes. Results The cohort included 23 subjects averaging 69.1 ± 7.2 years of age. Their mean CHADS2 score averaged 1.9 ± 0.8. Note that 26.1% underwent direct current cardioversion prior to discharge; 95.7% left the hospital taking amiodarone and 26.1% warfarin. A total of 14 patients (60.9%) experienced recurrent AF. AF first recurred within 3 months in nine patients (39.1%), and in 10 patients AF emerged or continued beyond 3 months. Eight of 17 (47.1%) patients followed for at least 1 year experienced AF recurrence beyond 1 year of CABG. The time from surgery to first AF episode averaged 143 ± 22.5 days. Long-term monitoring shows that 60.9% of patients with POAF develop recurrent AF. Conclusion POAF may represent a propensity for recurrent paroxysmal atrial fibrillation, and not simply a transient consequence of postoperative stress and inflammation. Better detection of recurrent AF might identify patients at risk for stroke who would benefit from continuing anticoagulation. [ABSTRACT FROM AUTHOR]
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- 2016
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17. Outcome of Subcutaneous Implantable Cardioverter Defibrillator Implantation in Patients with End-Stage Renal Disease on Dialysis.
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EL‐CHAMI, MIKHAEL F., LEVY, MATHEW, KELLI, HEVAL M., CASEY, MARY, HOSKINS, MICHAEL H., GOYAL, ABHINAV, LANGBERG, JONATHAN J., PATEL, ANSHUL, DELURGIO, DAVID, LLOYD, MICHAEL S., LEON, ANGEL R., and MERCHANT, FAISAL M.
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CARDIAC arrest , *CHRONIC kidney failure , *FISHER exact test , *HEMODIALYSIS patients , *IMPLANTABLE cardioverter-defibrillators , *RISK assessment , *SURGICAL complications , *T-test (Statistics) , *TREATMENT effectiveness , *RETROSPECTIVE studies , *DATA analysis software , *DESCRIPTIVE statistics , *KAPLAN-Meier estimator , *LOG-rank test , *ONE-way analysis of variance - Abstract
Subcutaneous ICD in Dialysis Patients Background Although the subcutaneous ICD (S-ICD®) is an attractive alternative in patients with end-stage renal disease (ESRD), data on S-ICD outcomes in dialysis patients are lacking. Methods Patients with cardiomyopathy undergoing S-ICD implantation in our center were stratified by need for chronic dialysis at the time of implant. The primary endpoint was incidence of death, heart failure hospitalization or appropriate S-ICD shocks, and secondary endpoints were incidence of inappropriate shocks or implant related complications requiring surgical re-intervention. Mean follow-up was longer in the nondialysis cohort (514 ± 495 vs. 227 ± 233 days, P = 0.006), so all endpoints were analyzed using time-dependent comparisons and reported as annual event rates. Results Out of 79 S-ICD implants included in this analysis, 27 patients were on dialysis. Dialysis patients were older and more likely to be diabetic. Mean ejection fraction across the entire cohort was 26.9% without significant difference between dialysis and nondialysis groups. Although not significant, the incidence of the primary endpoint was higher in the dialysis cohort (23.8%/year vs. 10.9%/year, P = 0.317), driven primarily by a higher rate of appropriate shocks. The rate of inappropriate shocks was similar between groups (dialysis 6.0%/year vs. nondialysis 6.8%/year, P = 0.509). No patients in the dialysis cohort had complications requiring surgical re-intervention versus 6 patients in the nondialysis cohort (P = 0.086). Conclusions Our data suggest that S-ICD implantation in dialysis patients is not associated with an excess risk of implant related complications or inappropriate shocks. [ABSTRACT FROM AUTHOR]
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- 2015
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18. Effect of Surgical Atrial Fibrillation Ablation at the Time of Cardiac Surgery on Risk of Postoperative Pacemaker Implantation.
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El-Chami, Mikhael F., Binongo, José Nilo G., Levy, Mathew, Merchant, Faisal M., Halkos, Michael, Thourani, Vinod, Lattouf, Omar, Guyton, Robert, Puskas, John, and Leon, Angel R.
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ATRIAL fibrillation treatment , *COMPLICATIONS of cardiac surgery , *CARDIAC pacemakers , *TREATMENT effectiveness , *CATHETER ablation , *LOGISTIC regression analysis , *CORONARY heart disease complications , *ATRIAL fibrillation , *CARDIAC pacing , *CORONARY artery bypass , *POSTOPERATIVE care , *RISK assessment , *DISEASE prevalence , *RETROSPECTIVE studies - Abstract
The aim of this study was to retrospectively investigate whether performing surgical atrial fibrillation (AF) ablation in conjunction with cardiac surgery (CS) increases the risk for postoperative permanent pacemaker (PPM) requirement. The 30-day risk for PPM requirement was analyzed in consecutive patients who underwent CS from January 2007 to August 27, 2013. Patients were divided into 3 groups: (1) those who underwent AF ablation concomitant with CS (AF ABL), (2) patients with any history of AF who underwent surgery who did not undergo ablation (AF NO ABL), and (3) those with no histories of AF who underwent surgery (NO AF). Logistic regression analysis was performed adjusting for age, gender, and surgery type. Of 13,453 CS patients, 353 (3%) were in the AF ABL group, 1,701 (12%) in the AF NO ABL group, and 11,399 (85%) in the NO AF group. A total of 7,651 patients (57%) underwent coronary artery bypass grafting, 4,384 (33%) underwent valve surgery, and 1,418 (10%) underwent coronary artery bypass grafting and valve surgery. The overall PPM risk was 1.6% (212 of 13,453); risk was 5.7% (20 of 353) in the AF ABL group, 3.1% (53 of 1,701) in the AF NO ABL group, and 1.2% (139 of 11,399) in the NO AF group. The unadjusted and adjusted odds of PPM were higher in the AF ABL and AF NO ABL groups than in the NO AF group (adjusted odds ratio [OR] 2.7, 95% confidence interval [CI] 1.7 to 4.4, and adjusted OR 1.7, 95% CI 1.2 to 2.4, respectively). The unadjusted OR comparing the AF ABL group and the AF NO ABL group was significant (unadjusted OR 1.9, 95% CI 1.9 to 3.2); however, the OR adjusted for surgery type, age, and gender showed a trend toward significance (adjusted OR 1.6, 95% CI 0.9 to 2.7). In conclusion, in this large cohort of patients who underwent CS, surgical AF ablation appeared to carry an increased risk for postoperative PPM implantation. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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19. The saga of tendril leads continues: Should we continue to bury our heads in the sand?
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El‐Chami, Mikhael F.
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ELECTRODES , *SERIAL publications , *IMPLANTABLE cardioverter-defibrillators , *ARTIFICIAL implants , *CARDIAC pacemakers , *COMPLICATIONS of prosthesis - Abstract
The author discusses a study by Adelstein and colleagues on pacemaker leads performance in their center. He discusses indications that Abbott sensing algorithms are not responsible for the higher rate of noise encountered with Tendril leads, the need of physicians to be proactive about reporting their experience, and an overview of studies assessing performance of tendril lead family.
- Published
- 2021
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20. Ventricular Arrhythmia After Cardiac Surgery: Incidence, Predictors, and Outcomes
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El-Chami, Mikhael F., Sawaya, Fadi J., Kilgo, Patrick, Stein, William, Halkos, Michael, Thourani, Vinod, Lattouf, Omar M., Delurgio, David B., Guyton, Robert A., Puskas, John D., and Leon, Angel R.
- Subjects
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VENTRICULAR arrhythmia , *COMPLICATIONS of cardiac surgery , *DISEASE incidence , *HEALTH outcome assessment , *DISEASE prevalence , *COHORT analysis , *MULTIVARIATE analysis , *VITAL records (Births, deaths, etc.) , *DIAGNOSIS - Abstract
Objectives: This study sought to investigate the prevalence, predictors, and outcomes of patients with post-operative ventricular arrhythmia (POVA) in a large cohort of patients. Background: New-onset POVA after cardiac surgery (CS) is uncommon and has controversial prognostic value. Methods: A total of 14,720 consecutive patients undergoing CS at Emory University between January 2004 and July 2010 were included in the study. Data on all-cause mortality were obtained from Social Security Administration death records. Multivariable regression models were constructed to determine the risk factors for POVA and to estimate the independent impact of POVA on long-term survival after adjusting for 40 different covariates. Results: POVA occurred in 248 patients (1.7%). Patients with POVA were older (63.5 vs. 61.6 years), had lower left ventricular ejection fraction (EF) (43.7 vs. 51.3), and had greater comorbidities (Society of Thoracic Surgeons mortality risk score of 7.2% vs. 3.1%, p < 0.001). Multivariable analysis showed that older age (odds ratio [OR]: 1.018 per 1-year increase, p < 0.001), emergent surgery (OR: 1.77, p = 0.019), and the presence of PVD (OR: 1.41, p = 0.049) were associated with a higher incidence of POVA, whereas higher left ventricular EF (OR: 0.97 per 1% increase, p < 0.001), mild chronic obstructive pulmonary disease (OR: 0.37, p < 0.001), and off-pump surgery (OR: O.41, p < 0.001) were associated with a lower incidence of POVA. POVA was associated with substantially increased adjusted long-term mortality (hazard rate: 2.53, p < 0.001) over 3.5 years of follow-up. Conclusions: POVA is associated with increased long-term mortality after CS. Older age, PVD, lower EF, and emergent surgery are associated with a higher risk of POVA, whereas off-pump surgery seems to be protective. [ABSTRACT FROM AUTHOR]
- Published
- 2012
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21. Prediction of New Onset Atrial Fibrillation After Cardiac Revascularization Surgery
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El-Chami, Mikhael F., Kilgo, Patrik D., Elfstrom, K. Miriam, Halkos, Michael, Thourani, Vinod, Lattouf, Omar M., Delurgio, David B., Guyton, Robert A., Leon, Angel R., and Puskas, John D.
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ATRIAL fibrillation risk factors , *REVASCULARIZATION (Surgery) , *CORONARY artery bypass , *MORTALITY , *MEDICAL statistics , *SURGICAL complications - Abstract
The aim of this study was to create a simple risk index to predict new-onset atrial fibrillation (AF) after coronary artery bypass grafting in patients with histories of AF. AF after coronary artery bypass grafting (referred to here as AF) is associated with increased morbidity and mortality. Identifying patients at high risk for developing AF may help identify a group of patients who might benefit from strategies to prevent postoperative AF. A cohort of 18,517 patients enrolled from January 1, 1996, to December 31, 2009, was used to derive a risk index for AF prediction. A multivariate logistic regression model determined the independent predictive impact of clinical and demographic characteristics on the occurrence of AF. A subset of these variables was used to construct a risk index to predict AF. This risk index was validated in a sequential cohort of 1,378 consecutive patients who underwent coronary artery bypass grafting from January 1, 2010, to June 30, 2011. AF occurred in 3,486 patients in the calibration cohort (18.83%) and in 269 patients in the validation cohort (19.52%). After considering patients'' demographics, co-morbid conditions, and severity of illness, advanced age appeared as the most powerful predictor of AF (odds ratio 1.059/year, 95% confidence interval 1.055 to 1.063). Age, height, weight, and the presence of peripheral vascular disease contributed most to the prediction model. An AF risk index including these variables had adequate discriminatory power, with a concordance index of 0.68. In conclusion, using a large cohort of patients, a simple risk index relying only on preoperative clinical variables was developed, which will help predict AF. This risk index can be used clinically to identify patients at high risk for the development of AF. [Copyright &y& Elsevier]
- Published
- 2012
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22. New-Onset Atrial Fibrillation Predicts Long-Term Mortality After Coronary Artery Bypass Graft
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El-Chami, Mikhael F., Kilgo, Patrick, Thourani, Vinod, Lattouf, Omar M., Delurgio, David B., Guyton, Robert A., Leon, Angel R., and Puskas, John D.
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- *
CORONARY artery bypass , *COMPLICATIONS of cardiac surgery , *ATRIAL fibrillation , *HEART disease related mortality , *MYOCARDIAL depressants , *CONFIDENCE intervals , *DEATH certificates , *REGRESSION analysis , *PATIENTS - Abstract
Objectives: We sought to investigate the association between new-onset atrial fibrillation after coronary artery bypass graft (CABG) (post-operative atrial fibrillation [POAF]) and long-term mortality in patients with no history of atrial fibrillation. Background: POAF predicts longer hospital stay and greater post-operative mortality. Methods: A total of 16,169 consecutive patients with no history of AF who underwent isolated CABG at our institution between January 1, 1996, and December 31, 2007, were included in the study. All-cause mortality data were obtained from Social Security Administration death records. A multivariable Cox proportional hazards regression model was constructed to determine the independent impact of new-onset POAF on long-term survival after adjusting for several covariates. The covariates included age, sex, race, pre-operative risk factors (ejection fraction, New York Heart Association functional class, history of myocardial infarction, index myocardial infarction, stroke, chronic obstructive pulmonary disease, peripheral arterial disease, smoking, diabetes, renal failure, hypertension, dyslipidemia, creatinine level, dialysis, redo surgery, elective versus emergent CABG, any valvular disorder) and post-operative adverse events (stroke, myocardial infarction, acute respiratory distress syndrome, and renal failure), and discharge cardiac medications known to affect survival in patients with coronary disease. Results: New-onset AF occurred in 2,985 (18.5%) patients undergoing CABG. POAF independently predicted long-term mortality (hazard ratio: 1.21; 95% confidence interval: 1.12 to 1.32) during a mean follow-up of 6 years (range 0 to 12.5 years). This association remained true after excluding from the analysis those patients who died in-hospital after surgery (hazard ratio: 1.21; 95% confidence interval: 1.11 to 1.32). Patients with POAF discharged on warfarin experienced reduced mortality during follow-up. Conclusions: In this large cohort of patients, POAF predicted long-term mortality. Warfarin anticoagulation may improve survival in POAF. [Copyright &y& Elsevier]
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- 2010
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23. Pacing Features That Mimic Malfunction: A Review of Current Programmable and Automated Device Functions That Cause Confusion in the Clinical Setting.
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LLOYD, MICHAEL S., EL CHAMI, MIKHAEL F., and LANGBERG, JONATHAN J.
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IMITATIVE behavior , *ATRIAL fibrillation , *ARRHYTHMIA treatment , *ELECTRIC countershock , *AUTOMATION - Abstract
Modern implantable devices capable of pacing are armed with a multitude of programmable and automated features. While some features represent important advances in device safety and performance, many can also mimic device malfunction. This article discusses these features in terms of the confusion they may cause and highlights important clinical clues that aid in their recognition. [ABSTRACT FROM AUTHOR]
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- 2009
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24. Blunt Cardiac Trauma
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El-Chami, Mikhael F., Nicholson, William, and Helmy, Tarek
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TRAUMATISM , *CREATINE kinase , *ELECTROCARDIOGRAPHY , *BRUISES - Abstract
Abstract: The incidence of cardiac injury after blunt chest trauma is difficult to determine and ranges from 8% to 76%. Moreover, the clinical presentation varies tremendously without a real gold standard to exclude or document cardiac involvement. Electrocardiogram as a single test is not sensitive or specific for diagnosing cardiac contusion. Furthermore, creatine kinase MB is non-reliable in the setting of severe trauma involving the liver, intestines or diaphragm. Although troponins T and I are highly specific for cardiac injury, their sensitivity in the setting of trauma is poor. The echocardiogram is very useful in the evaluation of trauma patients with suspected cardiac involvement. However, poor windows in the setting of chest and lung injuries and in intubated patients might be a major problem limiting the accuracy of transthoracic echocardiogram. On the other hand, transesophageal echocardiogram seems to be more sensitive and specific in trauma patients and should be the test of choice in patients with high clinical suspicion for blunt cardiac trauma. [Copyright &y& Elsevier]
- Published
- 2008
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25. Response to the letter to the editor: Wettability and roughness: Important determinants of bacterial adhesion and biofilm formation.
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El‐Chami, Mikhael F., Mayotte, Jane, Bonner, Matt, Holbrook, Reece, Stromberg, Kurt, and Sohail, M. Rizwan
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BACTERIAL physiology , *BACTERIAL growth , *BIOFILMS , *CARDIAC pacemakers , *MICROBIOLOGICAL techniques , *POLYMERS , *MEDICAL equipment contamination , *COLONY-forming units assay , *PREVENTION - Published
- 2020
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26. Costs, efficiency, and patient‐reported outcomes associated with suture‐mediated percutaneous closure for atrial fibrillation ablation: Secondary analysis of a randomized clinical trial.
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Kiani, Soroosh, Eggebeen, Joel, Al‐Gibbawi, Mounir, Smith, Paige, Preiser, Thomas, Kundu, Suprateek, Zheng, Ziduo, Bhatia, Neal K., Shah, Anand D., Westerman, Stacy B., De Lurgio, David B., Tompkins, Christine M., Patel, Anshul M., El‐Chami, Mikhael F., Merchant, Faisal M., and Lloyd, Michael S.
- Abstract
Introduction Methods Results Conclusion To evaluate the cost and efficiency of suture‐mediated percutaneous closure (SMC) compared to manual compression (MC) after atrial fibrillation (AF) ablation.SMC has been demonstrated to be efficacious in reducing hemostasis and bedrest times after AF ablation. To date, randomized data comparing the direct and indirect cost between the two techniques have not been described.We conducted a 1:1 randomized trial comparing SMC to MC following AF ablation. The primary endpoints have been previously published. However, secondary endpoints pertinent to indirect cost including complication rates, hospital utilization (i.e., delays in discharge, additional patient encounters, nursing utilization), pain, patient reported outcomes, as well as the direct costs of care associated with AF ablation were collected. We also performed secondary analysis of the primary endpoint to evaluate for a learning curve, and subgroups analysis comparing efficacy across different numbers of access sites and compared to those in the MC group with a figure‐of‐eight suture (Fo8), that could potentially have impacted the relative efficiency of the procedure.A total of 107 patients were randomized and included: 53 in the SMC group and 54 in MC. A learning curve was observed in the SMC group between the first and second half of the study group (
p = 0.037), with no such difference in the MC group. After accounting for the number of access sites, time to hemostasis remained shorter in the SMC Group (p = 0.002). Compared to those in the Fo8 arm (n = 37), the time to hemostasis remained shorter in the SMC group (p = 0.001). Among those planned for same‐day discharge, there were more delays in the MC group (31.5% vs. 11.3%,p = 0.0144). Rates of major and minor complications were similar between SMC and MC groups at discharge (p = 0.243) and 30 days (p = 1.00), as were nursing utilization, self‐reported pain, and overall patient reported outcomes. The overall cost of care related to the procedure was similar between the MC and SMC groups ($56 533.65 [$45 699.47, $66 987.64] vs. $57 050.44 [$47 251.40, $66 426.34],p = 0.601).SMC has been shown to decrease time to hemostasis and ambulation and facilitate earlier same‐day discharge after AF ablation without an increase in direct or indirect costs. [ABSTRACT FROM AUTHOR]- Published
- 2024
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27. Spontaneous fluctuation in atrial fibrillation burden and duration in patients with implantable loop monitors.
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Mekary, Wissam, Campbell, Martin, Bhatia, Neal K., Westerman, Stacy, Shah, Anand, Leal, Miguel, Delurgio, David, Patel, Anshul M., Tompkins, Christine, El‐Chami, Mikhael F., and Merchant, Faisal M.
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ANTICOAGULANTS , *RHYTHM - Abstract
Background Objective Methods Results Conclusion Most studies of device‐detected atrial fibrillation (AF) have recommended indefinite anticoagulation once a patient crosses a particular threshold for AF duration or burden. However, durations and burdens are known to fluctuate over time, but little is known about the magnitude of spontaneous fluctuations and the potential impact on anticoagulation decisions.To quantify spontaneous fluctuations in AF duration and burden in patients with implantable loop recorders (ILRs)We reviewed all ILR interrogations for patients with non‐permanent AF at our institution from 2018 to 2023. We excluded patients treated with rhythm control. The duration of longest AF episode at each interrogation was classified as < 6, 6–24, and > 24 h, and the AF burden reported at each interrogation was classified as < 2%, 2%–11.4%, and > 11.4%.Out of 156 patients, the mean age at ILR implant was 70.9 ± 12.5 years, CHA2DS2‐VASc score was 4.2 ± 1.8, duration of ILR follow‐up was 23.4 ± 11.2 months, and number of ILR interrogations per patient was 18.0 ± 8.9. The duration of longest AF episode at any point during follow‐up was < 6 , 6–24 , and > 24 h in 110, 30, and 16 patients, respectively. Among the 30 patients with a longest AF episode of 6–24 h at some point during follow‐up, out of 594 total ILR interrogations, only 75 (12%) showed a longest episode of 6–24 h. In the remaining 519 interrogations, the longest episode was < 6 h. In patients with a longest episode of > 24 h at any point during follow‐up (
n = 16), only 47 out of 320 total ILR interrogations (15%) showed an episode of > 24 h. When evaluating AF burden, 96, 38, and 22 patients had maximum reported AF burdens of < 2%, 2%–11.4%, and > 11.4% at any point during ILR follow‐up. Among those with a maximum burden of 2%–11.4% at some point during follow‐up (n = 38), out of 707 ILR interrogations, only 76 (11%) showed a burden of 2%–11.4%. In the remaining 631 interrogations, the burden was < 2%. In the 22 patients with a burden > 11.4% at some point during follow‐up, only 80 out of 480 interrogations (17%) showed a burden of > 11.4%. In 65% of interrogations, the burden was < 2%.Significant, spontaneous fluctuations in AF burden and duration are common in patients with ILRs. Even in patients with AF episodes of 6–24 h or > 24 h at some point during follow‐up, the vast majority of interrogations show episodes of < 6 h. Similarly, in patients with burdens of 2%–11.4% or > 11.4% at some point during follow‐up, the vast majority of interrogations show burdens of < 2%. More data are needed to determine whether crossing an AF burden or duration threshold once is sufficient to merit lifelong anticoagulation or whether spontaneous fluctuations in AF burden and duration should impact anticoagulation decisions. [ABSTRACT FROM AUTHOR]- Published
- 2024
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28. Process mapping strategies to prevent subcutaneous implantable cardioverter‐defibrillator infections.
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Weiss, Raul, Mark, George E., El‐Chami, Mikhael F., Biffi, Mauro, Probst, Vincent, Lambiase, Pier D., Miller, Marc A., McClernon, Timothy, Hansen, Linda K., Knight, Bradley P., and Baddour, Larry M.
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INFECTION prevention , *CONSENSUS (Social sciences) , *CATHETER-related infections , *IMPLANTABLE cardioverter-defibrillators , *ENDOCARDITIS , *ANTIBIOTIC prophylaxis , *SURGICAL site infections , *COMPLICATIONS of prosthesis , *BLOODBORNE infections - Abstract
Background: Infection remains a major complication of cardiac implantable electronic devices and can lead to significant morbidity and mortality. Implantable devices that avoid 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 endocarditis. While the 2017 AHA/ACC/HRS guidelines include recommendations for S‐ICD use for patients at high risk of infection, currently, there are no clinical trial data that address best practices for the prevention of S‐ICD infections. Therefore, an expert panel was convened to develop a consensus on these topics. Methods: An expert process mapping methodology was used to achieve consensus on the appropriate steps to minimize or prevent S‐ICD infections. Two face‐to‐face meetings of high‐volume S‐ICD implanters and an infectious diseases specialist, with expertise in cardiovascular implantable electronic device infections, were conducted to develop consensus on useful strategies pre‐, peri‐, and postimplant to reduce S‐ICD infection risk. Results: Expert panel consensus on recommended steps for patient preparation, S‐ICD implantation, and postoperative management was developed to provide guidance in individual patient management. Conclusion: Achieving expert panel consensus by process mapping methodology for S‐ICD infection prevention was attainable, and the results should be helpful to clinicians in adopting interventions to minimize risks of S‐ICD infection. [ABSTRACT FROM AUTHOR]
- Published
- 2022
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29. Intermittent Variation in Paced QRS Morphology: What Is the Mechanism?
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EL‐CHAMI, MIKHAEL, YOO, DALE, and HOSKINS, MICHAEL H.
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BUNDLE-branch block , *CARDIAC pacing , *IMPLANTABLE cardioverter-defibrillators , *CARDIOMYOPATHIES , *MEDICAL equipment reliability , *THERAPEUTICS - Abstract
The article presents a case study of a 75 year old woman with a history of dilated cardiomyopathy, left bundle branch block, and New York Heart Association class III symptoms who received a cardiac resynchronization therapy defibrillator and developed intermittent variation in paced QRS morphology after receiving the defibrillator. A discussion of the factors which could have led to the variation in the morphology is presented.
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- 2010
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30. Pseudo-Ventricular Over and Under-Sensing during an Episode of Double Tachycardia. What is the Mechanism?
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FERRARA, DARDO E. and EL‐CHAMI, MIKHAEL F.
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IMPLANTABLE cardioverter-defibrillators , *CARDIOMYOPATHIES , *IMPLANTED cardiovascular instruments , *DIAGNOSTIC errors , *DIAGNOSIS - Abstract
The author presents a case of ischemic cardiomyopathy in a man with a dual chamber implantable cardioverter defibrillator. Analysis of stored information in the device raised concerns about sensing abnormalities that were found to be due to a misalignment of marker notations. Concerns about misdiagnosis are discussed.
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- 2010
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31. A Diagnostic Response of a Supraventricular Tachycardia to a Ventricular Premature Beat.
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EL‐CHAMI, MIKHAEL F., BLATT, JACOB, and LLOYD, MICHAEL S.
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TACHYCARDIA , *CASE method (Teaching) , *ARRHYTHMIA , *ATRIOVENTRICULAR node , *HEART septum , *CARDIAC contraction - Abstract
The article describes the condition of a 36-year-old man who had palpitations since his childhood and was evaluated via an electrophysiologic study. The mechanism of tachycardia, atrial stimulation, atypical atrioventricular nodal reentrant tachycardia, low septal atrial tachycardia, and orthodromic reciprocating tachycardia, a conducting accessory pathway, and premature ventricular contraction are discussed.
- Published
- 2009
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32. Reply to letter to the editor: "Overcoming difficulties with persistent left superior vena cava".
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El‐Chami, Mikhael F.
- Subjects
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CARDIAC pacing , *IMPLANTABLE cardioverter-defibrillators , *SURGICAL complications , *VENA cava superior , *TREATMENT effectiveness - Published
- 2020
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33. Impact of omitting the intravenous heparin bolus on outcomes of leadless pacemaker implantation.
- Author
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Huang, Jingwen, Bhatia, Neal K., Lloyd, Michael S., Westerman, Stacy, Shah, Anand, Delurgio, David, Patel, Anshul M., Tompkins, Christine, El‐Chami, Mikhael F., and Merchant, Faisal M.
- Subjects
- *
HEART diseases , *MORTALITY , *PATIENT safety , *HEPARIN , *PATIENT readmissions , *ARTIFICIAL implants , *TREATMENT effectiveness , *DESCRIPTIVE statistics , *HEMATOMA , *INTRAVENOUS therapy , *FALSE aneurysms , *CARDIAC pacemakers , *ELECTRODES , *CARDIAC surgery , *THROMBOSIS ,PREVENTION of surgical complications - Abstract
Background: Early guidance recommended a bolus of intravenous heparin at the beginning of leadless pacemaker (LP) implantation procedures. However, due to concern about bleeding complications, more recent practice has tended toward omitting the bolus and only running a continuous heparin infusion through the introducer sheath. The impact of omitting the heparin bolus on procedural outcomes is not clear. Methods: We reviewed all Medtronic Micra LP implants at our institution from 9/2014 to 9/2022. The decision to bolus with heparin was at operator discretion. Results: Among 621 LP implants, 326 received an intravenous heparin bolus, 243 did not, and 52 patients were excluded because heparin bolus status could not be confirmed. There was a trend toward more frequent omission of the heparin bolus with more recent implants. Median follow‐up after LP implant was 14.3 (interquartile range [IQR]: 8.4–27.9) months. There was no difference between heparin bolus and no bolus groups in the number of device deployments/recaptures (1.42 ± 0.81 vs. 1.31 ± 0.66, p =.15). Implant‐related adverse events were also similar between heparin bolus and no bolus groups: access‐site hematoma requiring intervention (7 vs. 5, p =.99), pseudoaneurysm (1 vs. 1, p =.99), cardiac perforation (1 vs. 1, p =.99), intraprocedural device thrombus formation (2 vs. 4, p =.41), 30‐day rehospitalization (21 vs. 15, p =.98), and 30‐day all‐cause mortality (16 vs. 14, p =.70). There was one additional nonfatal cardiac perforation in a patient who was excluded due to unknown heparin bolus status. Regarding device electrical parameters between heparin bolus and no bolus groups, there were no significant differences at the time of implant: pacing capture threshold 0.5 ± 0.4 vs. 0.5 ± 0.3, p =.10; pacing impedance 739.9 ± 226.4 vs. 719.1 ± 215.4, p =.52; R wave sensing 11.7 ± 5.7 vs. 12.0 ± 5.4, p =.34). Long‐term device performance was also similar between groups. Conclusion: Omission of the systemic heparin bolus at the time of LP implantation appears safe in appropriately selected patients. Heparin bolus may still be considered in long cases requiring multiple device deployments or in patients at high risk for thrombotic complications. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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34. Outcomes of tricuspid regurgitation after lead extraction.
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Shanafelt, Colby, Middour, Thomas G., Ibrahim, Rand, Leal, Miguel, Lloyd, Michael S., Shah, Anand D., Westerman, Stacy B., El‐Chami, Mikhael F., Merchant, Faisal M., and Bhatia, Neal K.
- Subjects
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TRICUSPID valve , *T-test (Statistics) , *TREATMENT effectiveness , *MEDICAL device removal , *CHI-squared test , *DESCRIPTIVE statistics , *PRE-tests & post-tests , *MITRAL valve insufficiency , *IMPLANTABLE cardioverter-defibrillators , *CARDIAC pacing , *DATA analysis software , *TRICUSPID valve diseases , *ELECTROPHYSIOLOGY , *ECHOCARDIOGRAPHY - Abstract
Introduction: Transvenous leads have been implicated in tricuspid valve (TV) dysfunction, but limited data are available regarding the effect of extracting leads across the TV on valve regurgitation. The aim of this study is to quantify tricuspid regurgitation (TR) before and after lead extraction and identify predictors of worsening TR. Methods: We studied 321 patients who had echocardiographic data before and after lead extraction. TR was graded on a scale (0 = none/trivial, 1 = mild, 2 = moderate, 3 = severe). A change of >1 grade following extraction was considered significant. Results: A total of 321 patients underwent extraction of a total of 338 leads across the TV (1.05 ± 0.31 leads across the TV per patient). There was no significant difference on average TR grade pre‐ and postextraction (1.18 ± 0.91 vs. 1.15 ± 0.87; p = 0.79). TR severity increased after extraction in 84 patients, but was classified as significantly worse (i.e., >1 grade change in severity) in only 8 patients (2.5%). Use of laser lead extraction was associated with a higher rate of worsening TR postextraction (44.0% vs. 31.6%, p = 0.04). Conclusion: In our single‐center analysis, extraction of leads across the TV did not significantly affect the extent of TR in most patients. Laser lead extraction was associated with a higher rate of worsening TR after extraction. [ABSTRACT FROM AUTHOR]
- Published
- 2024
- Full Text
- View/download PDF
35. Response to the Letter to the Editor "Selection of Appropriate Patients for Figure‐of‐Eight Suturing During Removal of Large Bore Transfemoral Sheaths".
- Author
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Kiani, Soroosh and El‐Chami, Mikhael F.
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CARDIAC pacemakers , *PATIENT safety , *SUTURING , *PATIENT selection , *MEDICAL device removal , *PERIOPERATIVE care , *VASCULAR closure devices ,PREVENTION of surgical complications ,SURGICAL complication risk factors - Published
- 2019
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36. INCIDENCE OF CANCER TREATMENT-INDUCED ARRHYTHMIA ASSOCIATED WITH NOVEL TARGETED CHEMOTHERAPEUTIC AGENTS.
- Author
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Nickel, Andrew, El-Chami, Mikhael, Saba, Nabil F., Leon, Angel, and Merchant, Faisal
- Published
- 2018
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37. Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial.
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Gold, Michael R., Lambiase, Pier D., El-Chami, Mikhael F., Knops, Reinoud E., Aasbo, Johan D., Bongiorni, Maria Grazia, Russo, Andrea M., Deharo, Jean-Claude, Burke, Martin C., Dinerman, Jay, Barr, Craig S., Shaik, Naushad, Carter, Nathan, Stoltz, Thomas, Stein, Kenneth M., Brisben, Amy J., Boersma, Lucas V. A., Boersma, Lucas V, and UNTOUCHED Investigators
- Subjects
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IMPLANTABLE cardioverter-defibrillators , *VENTRICULAR ejection fraction , *SUDDEN death prevention , *CARDIAC arrest , *CORONARY disease , *DRUG efficacy , *CONFIDENCE intervals , *ARRHYTHMIA prevention , *RESEARCH , *CLINICAL trials , *RESEARCH methodology , *MEDICAL cooperation , *EVALUATION research , *PREVENTIVE health services , *TREATMENT effectiveness , *COMPARATIVE studies , *STROKE volume (Cardiac output) , *DEFIBRILLATORS , *ARRHYTHMIA , *LONGITUDINAL method - Abstract
Background: 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 Primary Prevention Patients With Low Ejection Fraction) was designed to evaluate the IAS rate in a more typical, contemporary ICD patient population implanted with the S-ICD using standardized programming and enhanced discrimination algorithms.Methods: Primary prevention patients with left ventricular ejection fraction ≤35% and no pacing indications were included. Generation 2 or 3 S-ICD devices were implanted and programmed with rate-based therapy delivery for rates ≥250 beats per minute and morphology discrimination for rates ≥200 and <250 beats per minute. Patients were followed for 18 months. The primary end point was the IAS-free rate compared with a 91.6% performance goal, derived from the results for the ICD-only patients in the MADIT-RIT study (Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy). Kaplan-Meier analyses were performed to evaluate event-free rates for IAS, all-cause shock, and complications. Multivariable proportional hazard analysis was performed to determine predictors of end points.Results: S-ICD implant was attempted in 1116 patients, and 1111 patients were included in postimplant follow-up analysis. The cohort had a mean age of 55.8±12.4 years, 25.6% were women, 23.4% were Black, 53.5% had ischemic heart disease, 87.7% had symptomatic heart failure, and the mean left ventricular ejection fraction was 26.4±5.8%. Eighteen-month freedom from IAS was 95.9% (lower confidence limit, 94.8%). Predictors of reduced incidence of IAS were implanting the most recent generation of device, using the 3-incision technique, no history of atrial fibrillation, and ischemic cause. The 18-month all-cause shock-free rate was 90.6% (lower confidence limit, 89.0%), meeting the prespecified performance goal of 85.8%. Conversion success rate for appropriate, discrete episodes was 98.4%. Complication-free rate at 18 months was 92.7%.Conclusions: This study demonstrates high efficacy and safety with contemporary S-ICD devices and programming despite the relatively high incidence of comorbidities in comparison with earlier S-ICD trials. The inappropriate shock rate (3.1% at 1 year) is the lowest reported for the S-ICD and lower than many transvenous ICD studies using contemporary programming to reduce IAS. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02433379. [ABSTRACT FROM AUTHOR]- Published
- 2021
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38. Update on Cardiovascular Implantable Electronic Device Infections and Their Prevention, Diagnosis, and Management: A Scientific Statement From the American Heart Association.
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Baddour, Larry M., Garrigos, Zerelda Esquer, Sohail, M. Rizwan, Havers-Borgersen, Eva, Krahn, Andrew D., Chu, Vivian H., Radke, Connie S., Avari-Silva, Jennifer, El-Chami, Mikhael F., Miro, Jose M., and DeSimone, Daniel C.
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ARTIFICIAL implants , *ELECTRONIC equipment , *INFECTION prevention , *DIAGNOSIS , *COMMUNICABLE diseases - Abstract
The American Heart Association sponsored the first iteration of a scientific statement that addressed all aspects of cardiovascular implantable electronic device infection in 2010. Major advances in the prevention, diagnosis, and management of these infections have occurred since then, necessitating a scientific statement update. An 11-member writing group was identified and included recognized experts in cardiology and infectious diseases, with a career focus on cardiovascular infections. The group initially met in October 2022 to develop a scientific statement that was drafted with front-line clinicians in mind and focused on providing updated clinical information to enhance outcomes of patients with cardiovascular implantable electronic device infection. The current scientific statement highlights recent advances in prevention, diagnosis, and management, and how they may be incorporated in the complex care of patients with cardiovascular implantable electronic device infection. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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- View/download PDF
39. Outcomes of leadless pacemaker implantation after cardiac surgery and transcatheter structural valve interventions.
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Huang, Jingwen, Bhatia, Neal K., Lloyd, Michael S., Westerman, Stacy, Shah, Anand, Leal, Miguel, Delurgio, David, Patel, Anshul M., Tompkins, Christine, Leon, Angel R., El‐Chami, Mikhael F., and Merchant, Faisal M.
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MITRAL valve surgery , *TRICUSPID valve surgery , *CARDIAC surgery , *MEDICAL equipment reliability , *PATIENT aftercare , *HEART transplantation , *HEART valve prosthesis implantation , *VENTRICULAR ejection fraction , *CORONARY artery bypass , *CARDIOMYOPATHIES , *RETROSPECTIVE studies , *TREATMENT effectiveness , *CARDIAC pacing , *COMMERCIAL product evaluation , *DESCRIPTIVE statistics , *CARDIAC pacemakers ,AORTIC valve surgery - Abstract
Introduction: Permanent pacing indications are common after cardiac surgery and transcatheter structural valve interventions. Leadless pacemakers (LPs) have emerged as a useful alternative to transvenous pacemakers. However, current commercially available LPs are unable to provide atrial pacing or cardiac resynchronization and relatively little is known about LP outcomes after cardiac surgery and transcatheter valve interventions. Methods: This retrospective study included patients who received a Micra VR (MicraTM MC1VR01) or Micra AV (MicraTM MC1AVR1) (Medtronic) leadless pacemaker following cardiac surgery or transcatheter structural valve intervention between September 2014 and September 2022. Device performance and clinical outcomes, including ventricular pacing burden, ejection fraction, and need for conversion to transvenous pacing systems, were evaluated during follow‐up. Results: A total of 78 patients were included, of whom 40 received a Micra VR LP implant, and 38 received a Micra AV LP implant. The mean age of the cohort was 65.9 ± 17.9 years, and 48.1% were females. The follow‐up duration for the entire cohort was 1.3 ± 1.1 years: 1.6 ± 1.3 years for the Micra VR group and 0.8 ± 0.5 years for the Micra AV group. Among the cohort, 50 patients had undergone cardiac surgery and 28 underwent transcatheter structural valve interventions. Device electrical performance was excellent during follow‐up, with a small but clinically insignificant increase in ventricular pacing threshold and a slight decrease in pacing impedance. The mean right ventricle pacing (RVP) burden significantly decreased over time in the entire cohort (74.3% ± 37.2% postprocedure vs. 47.7% ± 40.6% at last follow‐up, p <.001), and left ventricle ejection fraction (LVEF) showed a modest but significant downward trend during follow‐up (55.0% ± 10.6% vs. 51.5% ± 11.2% p <.001). Patients with Micra VR implants had significantly reduced LVEF during follow‐up (54.1% ± 11.9% vs. 48.8% ± 11.9%, p =.003), whereas LVEF appeared stable in the Micra AV group during follow‐up (56.1% ± 9.0% vs. 54.6% ± 9.7%, p =.06). Six patients (7.7%) required conversion to transvenous pacing systems, four who required cardiac resynchronization for drop in LVEF with high RVP burden and two who required dual‐chamber pacemakers for symptomatic sinus node dysfunction. Conclusion: Leadless pacemakers provide a useful alternative to transvenous pacemakers in appropriately selected patients after cardiac surgery and transcatheter structural valve interventions. Device performance is excellent over medium‐term follow‐up. However, a significant minority of patients require conversion to transvenous pacing systems for cardiac resynchronization or atrial pacing support, demonstrating the need for close electrophysiologic follow‐up in this cohort. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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40. Prospective validation of a risk score to predict pacemaker implantation after transcatheter aortic valve replacement.
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Black, George B., Kim, Joshua H., Vitter, Sophie, Ibrahim, Rand, Lisko, John C., Perdoncin, Emily, Shekiladze, Nikoloz, Gleason, Patrick T., Grubb, Kendra J., Greenbaum, Adam B., Devireddy, Chandan M., Guyton, Robert A., Leshnower, Bradley, Merchant, Faisal M., El‐Chami, Mikhael, Westerman, Stacy B., Shah, Anand D., Leon, Angel R., Lloyd, Michael S., and Babaliaros, Vasilis C.
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HEART valve prosthesis implantation , *CONFIDENCE intervals , *RESEARCH methodology evaluation , *DESCRIPTIVE statistics , *PREDICTION models , *CARDIAC pacemakers , *LOGISTIC regression analysis , *RECEIVER operating characteristic curves , *ODDS ratio , *LONGITUDINAL method - Abstract
Introduction: The need for pacemaker is a common complication after transcatheter aortic valve replacement (TAVR). We previously described the Emory Risk Score (ERS) to predict the need for new pacemaker implant (PPM) after TAVR. Metrics included in the score are a history of syncope, pre‐existing RBBB, QRS duration ≥140 ms, and prosthesis oversizing ≥16%. To prospectively validate the previously described risk score. Methods: We prospectively evaluated all patients without pre‐existing pacemakers, ICD, or pre‐existing indications for pacing undergoing TAVR with the Edwards SAPIEN 3 prosthesis at our institution from March 2019 to December 2020 (n = 661). Patients were scored prospectively; however, results were blinded from clinical decision‐making. The primary endpoint was PPM at 30 days after TAVR. Performance of the ERS was evaluated using logistic regression, a calibration curve to prior performance, and receiver operating characteristic (ROC) analysis. Results: A total of 48 patients (7.3%) had PPM after TAVR. A higher ERS predicted an increased likelihood of PPM (OR 2.61, 95% CI: 2.05–3.25 per point, p < 0.001). There was good correlation between observed and expected values on the calibration curve (slope = 1.04, calibration at large = 0.001). The area under the ROC curve was 0.81 (95% CI [0.74–0.88], p < 0.001). Conclusions: The ERS prospectively predicted the need for PPM in a serial, real‐world cohort of patients undergoing TAVR with a balloon‐expandable prosthesis, confirming findings previously described in retrospective cohorts. Notably, the prospective performance of the score was comparable with that of the initial cohorts. The risk score could serve as a framework for preprocedural risk stratification for PPM after TAVR. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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41. RISK OF POST CABG ATRIAL FIBRILLATION RECURRENCE USING AN IMPLANTABLE LOOP MONITOR: THE MONITOR-AF STUDY.
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El-Chami, Mikhael, Merchant, Faisal, Smith, Paige, Levy, Mathew, Merlino, John, and Leon, Angel
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ATRIAL fibrillation , *DISEASE relapse , *CORONARY artery bypass , *MORTALITY , *DISEASE incidence , *THROMBOEMBOLISM - Published
- 2016
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42. Adaptive versus conventional cardiac resynchronisation therapy in patients with heart failure (AdaptResponse): a global, prospective, randomised controlled trial.
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Wilkoff, Bruce L, Filippatos, Gerasimos, Leclercq, Christophe, Gold, Michael R, Hersi, Ahmad S, Kusano, Kengo, Mullens, Wilfried, Felker, G Michael, Kantipudi, Charan, El-Chami, Mikhael F, Essebag, Vidal, Pierre, Bertrand, Philippon, Francois, Perez-Gil, Francisco, Chung, Eugene S, Sotomonte, Juan, Tung, Stanley, Singh, Balbir, Bozorgnia, Babak, and Goel, Satish
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CARDIAC pacing , *HEART failure patients , *BUNDLE-branch block , *HEART failure - Abstract
Continuous automatic optimisation of cardiac resynchronisation therapy (CRT), stimulating only the left ventricle to fuse with intrinsic right bundle conduction (synchronised left ventricular stimulation), might offer better outcomes than conventional CRT in patients with heart failure, left bundle branch block, and normal atrioventricular conduction. This study aimed to compare clinical outcomes of adaptive CRT versus conventional CRT in patients with heart failure with intact atrioventricular conduction and left bundle branch block. This global, prospective, randomised controlled trial was done in 227 hospitals in 27 countries across Asia, Australia, Europe, and North America. Eligible patients were aged 18 years or older with class 2–4 heart failure, an ejection fraction of 35% or less, left bundle branch block with QRS duration of 140 ms or more (male patients) or 130 ms or more (female patients), and a baseline PR interval 200 ms or less. Patients were randomly assigned (1:1) via block permutation to adaptive CRT (an algorithm providing synchronised left ventricular stimulation) or conventional biventricular CRT using a device programmer. All patients received device programming but were masked until procedures were completed. Site staff were not masked to group assignment. The primary outcome was a composite of all-cause death or intervention for heart failure decompensation and was assessed in the intention-to-treat population. Safety events were collected and reported in the intention-to-treat population. This study is registered with ClinicalTrials.gov , NCT02205359 , and is closed to accrual. Between Aug 5, 2014, and Jan 31, 2019, of 3797 patients enrolled, 3617 (95·3%) were randomly assigned (1810 to adaptive CRT and 1807 to conventional CRT). The futility boundary was crossed at the third interim analysis on June 23, 2022, when the decision was made to stop the trial early. 1568 (43·4%) of 3617 patients were female and 2049 (56·6%) were male. Median follow-up was 59·0 months (IQR 45–72). A primary outcome event occurred in 430 of 1810 patients (Kaplan-Meier occurrence rate 23·5% [95% CI 21·3–25·5] at 60 months) in the adaptive CRT group and in 470 of 1807 patients (25·7% [23·5–27·8] at 60 months) in the conventional CRT group (hazard ratio 0·89, 95% CI 0·78–1·01; p=0·077). System-related adverse events were reported in 452 (25·0%) of 1810 patients in the adaptive CRT group and 440 (24·3%) of 1807 patients in the conventional CRT group. Compared with conventional CRT, adaptive CRT did not significantly reduce the incidence of all-cause death or intervention for heart failure decompensation in the included population of patients with heart failure, left bundle branch block, and intact AV conduction. Death and heart failure decompensation rates were low with both CRT therapies, suggesting a greater response to CRT occurred in this population than in patients in previous trials. Medtronic. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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43. SURGICAL AF ABLATION AT THE TIME OF CARDIAC SURGERY INCREASES THE RISK OF POSTOPERATIVE PACEMAKER IMPLANTATION.
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El-Chami, Mikhael, Kilgo, Patrick, Halkos, Michael, Thourani, Vinod, Lattouf, Omar, Leon, Angel, and Puskas, John
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- 2014
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44. Novel use of an irrigated ablation catheter to monitor real‐time hemodynamics during ablation.
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Bhatia, Neal K., Iravanian, Shahriar, Ravi, Namita, Kiani, Soroosh, Lloyd, Michael S., Westerman, Stacy B., Merchant, Faisal M., El‐Chami, Mikhael F., Hoque, Azizul, and Shah, Anand D.
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CENTRAL venous pressure , *SYSTOLIC blood pressure , *CATHETER ablation , *PATIENT monitoring , *ELECTROPHYSIOLOGY , *VENTRICULAR tachycardia , *WAVE analysis , *HEMODYNAMICS , *SWAN-Ganz catheters , *CATHETERS , *LEFT heart atrium , *HEART failure - Abstract
Introduction: Hemodynamic decompensation during catheter ablation occurs due to prolonged procedure time and irrigant delivery directly into the cardiac chambers. Real‐time hemodynamic monitoring of patients undergoing catheter ablation procedures may identify patients at risk of decompensation; we set out to assess the feasibility of a novel, real‐time, intracardiac pressure monitoring system using a standard irrigated ablation catheter. Methods: We studied 13 consecutive who underwent pressure measurement of the left atrium (LA) and left ventricle (LV) via transeptal access with a Swan Ganz (SG) catheter followed by two commercially available irrigated ablation catheters. Pressure waveform data was extracted to compare LA peak pressure, LV peak systolic pressure, LV end‐diastolic pressure, and waveform analysis. Results: Comparison between the SG and ablation catheters (AblA; AblB) demonstrated that LV systolic pressure (0.61–16.8 mmHg; 1.32–18.2 mmHg), and LV end‐diastolic pressure (−3.4 to 2.8 mmHg; −3.0 to 3.35 mmHg) were well correlated and had accepted repeatability. Ablation waveforms demonstrated an 89.9 ± 6.4% correlation compared to SG waveforms. Conclusion: Pressure measurements derived from an irrigated ablation catheter are accurate and reliable when compared to an SG catheter. Further studies are needed to determine how real‐time pressure monitoring can improve outcomes during ablation procedures. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
45. Leadless versus transvenous single‐chamber ventricular pacemakers: 3 year follow‐up of the Micra CED study.
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Crossley, George H., Piccini, Jonathan P., Longacre, Colleen, Higuera, Lucas, Stromberg, Kurt, and El‐Chami, Mikhael F.
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CAUSES of death , *CONFIDENCE intervals , *SURGERY , *PATIENTS , *HEART ventricles , *COMPARATIVE studies , *HEALTH insurance reimbursement , *CARDIAC pacing , *TREATMENT effectiveness , *HOSPITAL care , *DESCRIPTIVE statistics , *RESEARCH funding , *CARDIAC pacemakers , *HEART failure , *COMPLICATIONS of prosthesis , *LONGITUDINAL method , *MEDICARE - Abstract
Introduction: The Micra Coverage with Evidence Development (CED) Study is a novel comparative analysis of Micra (leadless VVI) and transvenous single‐chamber ventricular pacemakers (transvenous VVI) using administrative claims data. To compare chronic complications, device reinterventions, heart failure hospitalizations, and all‐cause mortality after 3 years of follow‐up. Methods: US Medicare claims data linked to manufacturer device registration information were used to identify Medicare beneficiaries with a de novo implant of either a Micra VR leadless VVI or transvenous VVI pacemaker from March 9, 2017 to December 31, 2018. Unadjusted and propensity score overlap‐weight adjusted Fine‐Gray competing risk models were used to compare outcomes at 3 years. Results: Leadless VVI patients (N = 6219) had a 32% lower rate of chronic complications and a 41% lower rate of reintervention compared with transvenous VVI patients (N = 10 212) (chronic complication hazard ratio [HR] 0.68; 95% confidence interval [CI], 0.59−0.78; reintervention HR 0.59; 95% CI 0.44−0.78). Infections rates were significantly lower among patients with a leadless VVI (<0.2% vs. 0.7%, p <.0001). Patients with a leadless VVI also had slightly lower rates of heart failure hospitalization (HR 0.90; 95% CI 0.84−0.97). There was no difference in the adjusted 3‐year all‐cause mortality rate (HR 0.97; 95% CI, 0.92−1.03). Conclusion: This nationwide comparative evaluation of leadless VVI versus transvenous VVI de novo pacemaker implants demonstrated that the leadless group had significantly fewer complications, reinterventions, heart failure hospitalizations, and infections than the transvenous group at 3 years, confirming that the previously reported shorter‐term advantages associated with leadless pacing persist and continue to accrue in the medium‐to‐long‐term. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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46. PREDICTORS AND OUTCOMES OF PATIENTS WITH VENTRICULAR ARRHYTHMIA AFTER CARDIAC SURGERY
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El-Chami, Mikhael, Kilgo, Patrick, Sawaya, Fadi, Halkos, Michael, DeLurgio, David, Leon, Angel, and Puskas, John
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- 2012
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47. Correlation between AV synchrony and device collected AM‐VP sequence counter in atrioventricular synchronous leadless pacemakers: A real‐world assessment.
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Garweg, Christophe, Piccini, Jonathan P., Epstein, Laurence M., Frazier‐Mills, Camille, Chinitz, Larry A., Steinwender, Clemens, Stromberg, Kurt, Sheldon, Todd, Fagan, Dedra H., and El‐Chami, Mikhael F.
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RETROSPECTIVE studies , *CARDIAC pacing , *HEART block , *TREATMENT effectiveness , *ELECTROPHYSIOLOGY , *ACCELEROMETRY , *ELECTROCARDIOGRAPHY , *DESCRIPTIVE statistics , *CARDIAC pacemakers , *HEART conduction system , *EQUIPMENT & supplies - Abstract
Introduction: Micra atrioventricular (AV) provides leadless atrioventricular synchronous pacing by sensing atrial contraction (A4 signal). Real‐world operation and reliability of AV synchrony (AVS) assessment using device data have not been described. The purposes of this study were to (1) assess the correlation between AVS and atrial mechanical sensed‐ventricular pacing (AM‐VP) percentages in patients with permanent high‐degree AV block and (2) report on the real‐world effectiveness of Micra AV. Methods: The correlation between ECG‐determined AVS in‐clinic and device‐collected %AM‐VP was assessed using data from 40 patients with high‐degree AV block enrolled in the Micra Atrial tRacking using a Ventricular AccELerometer (MARVEL) 2 study. A retrospective analysis to assess continuously‐sampled %AM‐VP since last session, device programming, and electrical parameters was performed using Micra AV transmissions from the Medtronic CareLink database. Patients with transmissions ≥180 days postimplant were included. Results: Among the 40 MARVEL 2 AV block patients with a median %VP of 99.7%, AVS was highly correlated with AM‐VP (median AVS 87.1%, median AM‐VP 79.1%; R2 = 0.764, p <.001). The CareLink cohort included 4384 patients programmed to VDD mode. The mean A4 amplitude was 2.3 ± 1.8 m/s2 at implant and 2.3 ± 1.6 m/s2 at 28 weeks. In patients with %VP >90% (n = 1662), the median %AM‐VP was 74.7%. For the full cohort, median %VP was 65.6% and median projected battery longevity was 10.5 years. Conclusion: In patients with a high pacing burden, %AM‐VP provides a reasonable estimation of AVS. The first large real‐world analysis of Micra AV patients with >90% VP showed stable atrial sensing over time with a median %AM‐VP, a correlate of AVS, of 74.7%. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
48. The Subcutaneous Defibrillator: A Review of the Literature.
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Aziz, Sally, Leon, Angel R., and El-Chami, Mikhael F.
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IMPLANTABLE cardioverter-defibrillators , *VENTRICULAR fibrillation treatment , *VENTRICULAR tachycardia , *CLINICAL trials , *SUBCUTANEOUS infusions , *THERAPEUTICS ,MEDICAL literature reviews - Abstract
The recently commercially available subcutaneous implantable cardioverter-defibrillator (S-ICD) uses a completely subcutaneous electrode configuration to treat potentially lethal ventricular tachyarrhythmia. Clinical trials have proven its effectiveness in detecting and treating ventricular fibrillation and tachycardia. The S-ICD offers the advantage of eliminating the need for intravenous and intracardiac leads and their associated risks and shortcomings. However, its major disadvantage is its inability to provide bradycardia rate support and antitachycardia pacing to terminate ventricular tachycardia. This paper discusses the S-ICD clinical trials and advantages and disadvantages of this novel technology to help the physician identify its role and select candidate patients who will benefit from this device. [Copyright &y& Elsevier]
- Published
- 2014
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49. Recurrence of new-onset post-operative AF after cardiac surgery: detected by implantable loop recorders: A systematic review and Meta-analysis.
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Kaur, Hargun, Tao, Brendan, Silverman, Max, Healey, Jeffrey S., Belley-Cote, Emilie P., Islam, Shofiqul, Whitlock, Richard P., Devereaux, Philip J., Conen, David, Bidar, Elham, Kawczynski, Michal, Ayala-Paredes, Félix, Ayala-Valani, Luciano M, Sandgren, Emma, El-Chami, Mikhael F, Jørgensen, Troels Højsgaard, Thyregod, Hans Gustav Hørsted, Sabbag, Avi, and McIntyre, William F.
- Abstract
Atrial fibrillation (AF) is one of the most common complications after cardiac surgery. New-onset post-operative AF may signal an elevated risk of AF and associated outcomes in long-term follow-up. We aimed to estimate the rate of AF recurrence as detected by an implantable loop recorder (ILR) in patients experiencing post-operative AF within 30 days after cardiac surgery. We searched MEDLINE, Embase and Cochrane CENTRAL to April 2023 for studies of adults who did not have known AF, experienced new-onset AF within 30 days of cardiac surgery and received an ILR. We pooled individual participant data on timing of AF recurrence using a random-effects model with a frailty model applied to a Cox proportional hazard analysis. From 8671 citations, 8 single-centre prospective cohort studies met eligibility criteria. Data were available from 185 participants in 7 studies, with a median follow-up of 1.7 (IQR: 1.3–2.8) years. All included studies were at a low risk of bias. Pooled AF recurrence rates following 30 post-operative days were 17.8% (95% CI 11.9%–23.2%) at 3 months, 24.4% (17.7%–30.6%) at 6 months, 30.1% (22.8%–36.7%) at 12 months and 35.3% (27.6%–42.2%) at 18 months. In patients who experience new-onset post-operative AF after cardiac surgery, AF recurrence lasting at least 30 s occurs in approximately 1 in 3 in the first year after surgery. The optimal frequency and modality to use for monitoring for AF recurrence in this population remain uncertain. • 1/3 with new-onset POAF experience recurrence within 1 year of cardiac surgery. • This is the largest cardiac surgery patient series with new-onset POAF and ILRs. • Future studies are needed to establish cut-offs of clinically important AF durations. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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- View/download PDF
50. Efficacy and Safety of Appropriate Shocks and Antitachycardia Pacing in Transvenous and Subcutaneous Implantable Defibrillators: Analysis of All Appropriate Therapy in the PRAETORIAN Trial.
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Knops, Reinoud E., van der Stuijt, Willeke, Delnoy, Peter Paul H.M., Boersma, Lucas V.A., Kuschyk, Juergen, El-Chami, Mikhael F., Bonnemeier, Hendrik, Behr, Elijah R., Brouwer, Tom F., Kaab, Stefan, Mittal, Suneet, Quast, Anne-Floor B.E., Smeding, Lonneke, Tijssen, Jan G.P., Bijsterveld, Nick R., Richter, Sergio, Brouwer, Marc A., de Groot, Joris R., Kooiman, Kirsten M. MPA, and Lambiase, Pier D.
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IMPLANTABLE cardioverter-defibrillators , *VENTRICULAR tachycardia , *VENTRICULAR arrhythmia , *PATIENTS' attitudes , *ARRHYTHMIA , *SECONDARY analysis , *ARRHYTHMIA treatment , *ARRHYTHMIA diagnosis , *RESEARCH , *EVALUATION research , *TREATMENT effectiveness , *COMPARATIVE studies , *LONGITUDINAL method - Abstract
Background: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) showed noninferiority of subcutaneous implantable cardioverter defibrillator (S-ICD) compared with transvenous implantable cardioverter defibrillator (TV-ICD) with regard to inappropriate shocks and complications. In contrast to TV-ICD, S-ICD cannot provide antitachycardia pacing for monomorphic ventricular tachycardia. This prespecified secondary analysis evaluates appropriate therapy and whether antitachycardia pacing reduces the number of appropriate shocks.Methods: The PRAETORIAN trial was an international, investigator-initiated randomized trial that included patients with an indication for implantable cardioverter defibrillator (ICD) therapy. Patients with previous ventricular tachycardia <170 bpm or refractory recurrent monomorphic ventricular tachycardia were excluded. In 39 centers, 849 patients were randomized to receive an S-ICD (n=426) or TV-ICD (n=423) and were followed for a median of 49.1 months. ICD programming was mandated by protocol. Appropriate ICD therapy was defined as therapy for ventricular arrhythmias. Arrhythmias were classified as discrete episodes and storm episodes (≥3 episodes within 24 hours). Analyses were performed in the modified intention-to-treat population.Results: In the S-ICD group, 86 of 426 patients received appropriate therapy, versus 78 of 423 patients in the TV-ICD group, during a median follow-up of 52 months (48-month Kaplan-Meier estimates 19.4% and 17.5%; P=0.45). In the S-ICD group, 83 patients received at least 1 shock, versus 57 patients in the TV-ICD group (48-month Kaplan-Meier estimates 19.2% and 11.5%; P=0.02). Patients in the S-ICD group had a total of 254 shocks, compared with 228 shocks in the TV-ICD group (P=0.68). First shock efficacy was 93.8% in the S-ICD group and 91.6% in the TV-ICD group (P=0.40). The first antitachycardia pacing attempt successfully terminated 46% of all monomorphic ventricular tachycardias, but accelerated the arrhythmia in 9.4%. Ten patients with S-ICD experienced 13 electrical storms, versus 18 patients with TV-ICD with 19 electrical storms. Patients with appropriate therapy had an almost 2-fold increased relative risk of electrical storms in the TV-ICD group compared with the S-ICD group (P=0.05).Conclusions: In this trial, no difference was observed in shock efficacy of S-ICD compared with TV-ICD. Although patients in the S-ICD group were more likely to receive an ICD shock, the total number of appropriate shocks was not different between the 2 groups. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022. [ABSTRACT FROM AUTHOR]- Published
- 2022
- Full Text
- View/download PDF
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