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3. Predictive value of the PRAETORIAN score for defibrillation test success in patients with subcutaneous ICD: A subanalysis of the PRAETORIAN-DFT trial

Author

Knops, Reinoud E., El-Chami, Mikhael F., Marquie, Christelle, Nordbeck, Peter, Quast, Anne-Floor B.E., Tilz, Roland R., Brouwer, Tom F., Lambiase, Pier D., Cassidy, Christopher J., Boersma, Lucas V.A., Burke, Martin C., Pepplinkhuizen, Shari, de Veld, Jolien A., de Weger, Anouk, Bracke, Frank A.L.E., Manyam, Harish, Probst, Vincent, Betts, Timothy R., Bijsterveld, Nick R., Defaye, Pascal, Demming, Thomas, Elders, Jan, Field, Duncan C., Ghani, Abdul, Golovchiner, Gregory, de Jong, Jonas S.S.G., Lewis, Nigel, Marijon, Eloi, Martin, Claire A., Miller, Marc A., Shaik, Naushad A., van der Stuijt, Willeke, Kuschyk, Jürgen, Olde Nordkamp, Louise R.A., Arya, Anita, Borger van der Burg, Alida E., Boveda, Serge, van Doorn, Dirk J., Glikson, Michael, Kaiser, Lukas, Maass, Alexander H., van Woerkens, Léon J.P.M., Zaidi, Amir, Wilde, Arthur A.M., and Smeding, Lonneke

Published
2024
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5. A leadless ventricular pacemaker providing atrioventricular synchronous pacing in the real-world setting: 12-Month results from the Micra AV post-approval registry

Author

Garweg, Christophe, Chinitz, Jason S., Marijon, Eloi, Haeberlin, Andreas, Winter, Stefan, Iacopino, Saverio, Curnis, Antonio, Breitenstein, Alexander, Hussin, Azlan, Mela, Theofanie, El-Chami, Mikhael F., Roberts, Paul R., Piccini, Jonathan P., Stromberg, Kurt, Fagan, Dedra H., and Clementy, Nicolas

Published
2024
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10. Safety of same-day discharge after lead extraction procedures

Author

Dagher, Lilas, Tfaily, Mohamad Ali, Vavuranakis, Michael, Bhatia, Neal Kumar, Westerman, Stacy B., Shah, Anand D., Lloyd, Michael S., Leal, Miguel, De Lurgio, David B., Merchant, Alam, Panagopoulos, Anastasios, Patel, Anshul M., Tompkins, Christine, Leon, Angel R., Merchant, Faisal M., and El-Chami, Mikhael F.

Published
2023
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11. Adaptive versus conventional cardiac resynchronisation therapy in patients with heart failure (AdaptResponse): a global, prospective, randomised controlled trial

Author

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, Goel, Satish, Ebert, Hans Holger, Varma, Niraj, Quan, Kara J, Salerno, Fiorella, Gerritse, Bart, van Wel, Janelle, Schaber, Daniel E, Fagan, Dedra H, and Birnie, David

Published
2023
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24. Leadless pacemaker implant, anticoagulation status, and outcomes: Results from the Micra Transcatheter Pacing System Post-Approval Registry

Author

El-Chami, Mikhael F., Garweg, Christophe, Iacopino, Saverio, Al-Samadi, Faisal, Martinez-Sande, Jose Luis, Tondo, Claudio, Johansen, Jens Brock, Prat, Xavier Viñolas, Piccini, Jonathan P., Cha, Yong Mei, Grubman, Eric, Bordachar, Pierre, Roberts, Paul R., Soejima, Kyoko, Stromberg, Kurt, Fagan, Dedra H., and Clementy, Nicolas

Published
2022
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25. Chronic kidney disease and transvenous cardiac implantable electronic device infection—is there an impact on healthcare utilization, costs, disease progression, and mortality?

Author

Wright, David J, Trucco, María Emilce, Zhou, Jiani, Wolff, Claudia, Holbrook, Reece, Margetta, Jamie, and El-Chami, Mikhael F

Abstract

Aims Cardiac implantable electronic device (CIED) infections are a burden to hospitals and costly for healthcare systems. Chronic kidney disease (CKD) increases the risk of CIED infections, but its differential impact on healthcare utilization, costs, and outcomes is not known. Methods and results This retrospective analysis used de-identified Medicare Fee-for-Service claims to identify patients implanted with a CIED from July 2016 to December 2020. Outcomes were defined as hospital days and costs within 12 months post-implant, post-infection CKD progression, and mortality. Generalized linear models were used to calculate results by CKD and infection status while controlling for other comorbidities, with differences between cohorts representing the incremental effect associated with CKD. A total of 584 543 patients had a CIED implant, of which 26% had CKD and 1.4% had a device infection. The average total days in hospital for infected patients was 23.5 days with CKD vs. 14.5 days (P < 0.001) without. The average cost of infection was $121 756 with CKD vs. $55 366 without (P < 0.001), leading to an incremental cost associated with CKD of $66 390. Infected patients with CKD were more likely to have septicaemia or severe sepsis than those without CKD (11.0 vs. 4.6%, P < 0.001). After infection, CKD patients were more likely to experience CKD progression (hazard ratio 1.26, P < 0.001) and mortality (hazard ratio 1.89, P < 0.001). Conclusion Cardiac implantable electronic device infection in patients with CKD was associated with more healthcare utilization, higher cost, greater disease progression, and greater mortality compared to patients without CKD. [ABSTRACT FROM AUTHOR]

Published
2024
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27. Predictors of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion

Author

Simard, Trevor, Jung, Richard G., Lehenbauer, Kyle, Piayda, Kerstin, Pracoń, Radoslaw, Jackson, Gregory G., Flores-Umanzor, Eduardo, Faroux, Laurent, Korsholm, Kasper, Chun, Julian K.R., Chen, Shaojie, Maarse, Moniek, Montrella, Kristi, Chaker, Zakeih, Spoon, Jocelyn N., Pastormerlo, Luigi E., Meincke, Felix, Sawant, Abhishek C., Moldovan, Carmen M., Qintar, Mohammed, Aktas, Mehmet K., Branca, Luca, Radinovic, Andrea, Ram, Pradhum, El-Zein, Rayan S., Flautt, Thomas, Ding, Wern Yew, Sayegh, Bassel, Benito-González, Tomás, Lee, Oh-Hyun, Badejoko, Solomon O., Paitazoglou, Christina, Karim, Nabeela, Zaghloul, Ahmed M., Agrawal, Himanshu, Kaplan, Rachel M., Alli, Oluseun, Ahmed, Aamir, Suradi, Hussam S., Knight, Bradley P., Alla, Venkata M., Panaich, Sidakpal S., Wong, Tom, Bergmann, Martin W., Chothia, Rashaad, Kim, Jung-Sun, Pérez de Prado, Armando, Bazaz, Raveen, Gupta, Dhiraj, Valderrabano, Miguel, Sanchez, Carlos E., El Chami, Mikhael F., Mazzone, Patrizio, Adamo, Marianna, Ling, Fred, Wang, Dee Dee, O’Neill, William, Wojakowski, Wojtek, Pershad, Ashish, Berti, Sergio, Spoon, Daniel, Kawsara, Akram, Jabbour, George, Boersma, Lucas V.A., Schmidt, Boris, Nielsen-Kudsk, Jens Erik, Rodés-Cabau, Josep, Freixa, Xavier, Ellis, Christopher R., Fauchier, Laurent, Demkow, Marcin, Sievert, Horst, Main, Michael L., Hibbert, Benjamin, Holmes, David R., Jr., and Alkhouli, Mohamad

Published
2021
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36. Impact of omitting the intravenous heparin bolus on outcomes of leadless pacemaker implantation.

Author

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
PREVENTION of surgical complications, 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
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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37. Outcomes of tricuspid regurgitation after lead extraction.

Author

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
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
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38. Leadless pacemakers at 5-year follow-up: the Micra transcatheter pacing system post-approval registry.

Author

El-Chami, Mikhael F, Garweg, Christophe, Clementy, Nicolas, Al-Samadi, Faisal, Iacopino, Saverio, Martinez-Sande, Jose Luis, Roberts, Paul R, Tondo, Claudio, Johansen, Jens Brock, Vinolas-Prat, Xavier, Cha, Yong-Mei, Grubman, Eric, Bordachar, Pierre, Stromberg, Kurt, Fagan, Dedra H, and Piccini, Jonathan P

Subjects
CARDIAC pacemakers, CARDIAC pacing, COMPETING risks, CONFIDENCE intervals
Abstract

Background and Aims Prior reports have demonstrated a favourable safety and efficacy profile of the Micra leadless pacemaker over mid-term follow-up; however, long-term outcomes in real-world clinical practice remain unknown. Updated performance of the Micra VR leadless pacemaker through five years from the worldwide post-approval registry (PAR) was assessed. Methods All Micra PAR patients undergoing implant attempts were included. Endpoints included system- or procedure-related major complications and system revision rate for any cause through 60 months post-implant. Rates were compared through 36 months post-implant to a reference dataset of 2667 transvenous pacemaker patients using Fine–Gray competing risk models. Results 1809 patients were enrolled between July 2015 and March 2018 and underwent implant attempts from 179 centres in 23 countries with a median follow-up period of 51.1 months (IQR: 21.6–64.2). The major complication rate at 60 months was 4.5% [95% confidence interval (CI): 3.6%–5.5%] and was 4.1% at 36 months, which was significantly lower than the 8.5% rate observed for transvenous systems (HR:.47, 95% CI:.36–.61; P <.001). The all-cause system revision rate at 60 months was 4.9% (95% CI: 3.9%–6.1%). System revisions among Micra patients were mostly for device upgrades (41.2%) or elevated thresholds (30.6%). There were no Micra removals due to infection noted over the duration of follow-up. At 36 months, the system revision rate was significantly lower with Micra vs. transvenous systems (3.2% vs. 6.6%, P <.001). Conclusions Long-term outcomes with the Micra leadless pacemaker continue to demonstrate low rates of major complications and system revisions and an extremely low incidence of infection. [ABSTRACT FROM AUTHOR]

Published
2024
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41. Efficacy and Safety of Appropriate Shocks and Antitachycardia Pacing in Transvenous and Subcutaneous Implantable Defibrillators: An Analysis of All Appropriate Therapy in the PRAETORIAN trial

Author

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., Lambiase, Pier D., Neuzil, Petr, Vernooy, Kevin, Alings, Marco, Betts, Timothy R., Bracke, Frank A.L.E., Burke, Martin C., de Jong, Jonas S.S.G., Wright, David J., Jansen, Ward P.J., Whinnet, Zachary I., Nordbeck, Peter, Knaut, Michael, Philbert, Berit T., van Opstal, Jurren M., Chicos, Alexandru B., Allaart, Cornelis P., van der Burg, Alida E. Borger, Clancy, Jude F., Dizon, Jose M., Miller, Marc A., Nemirovsky, Dmitry, Surber, Ralf, Upadhyay, Gaurav A., Weiss, Raul, de Weger, Anouk, Wilde, Arthur A.M., and Nordkamp, Louise R.A. Olde

Published
2021
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42. Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results

Author

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

Published
2019
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46. Recurrence of new-onset post-operative AF after cardiac surgery detected by implantable loop recorders: A systematic review and Meta-analysis

Author

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.

Published
2024
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47. Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial

Author

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., and Boersma, Lucas V.A.

Published
2021
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