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Kusumoto, Fred

https://orcid.org/0000-0002-8300-6277

Mayo Clinic

Mayo Clinic

Citations 49

Subclinical Venous Injury in Transvenous Lead Extraction: Histological Correlation With Clinical Risk Factors
Lateef, Azalfa , Vardar, Ufuk , Hochwald, Alex, Nassar, Aziza , Ladas, Thomas, Chiriac, Anca, Niekerk, Christoffel J. van , Kusumoto, Fred , Kella, Danesh , Lateef, Azalfa U , Van Niekerk, Christoff , Kella, Danesh K , Nassar, Aziza , Kusumoto, Fred M , Hochwald, Alexander , Ladas, Thomas P. , Chiriac, Anca

Journal of Cardiovascular Electrophysiology | July 8, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1111/jce.70402 Get It

ABSTRACT Background Transvenous lead extraction (TLE) is a commonly performed and generally safe procedure, though procedural complexity and risk can vary based on clinical and procedural factors. Objective This study aims to identify clinical and procedural factors associated with histologic evidence of subclinical vascular injury, defined by elastin positivity on extracted leads and its clinical significance. Methods Patients undergoing TLE with a lead dwell time of ≥ 1 year were included. Extracted leads with tissue were analyzed histologically using Verhoeff–Van Gieson staining to assess the presence of elastin. Demographic data, procedural and lead characteristics, and indication for extraction were obtained. Established extraction risk scores were calculated to determine efficacy in predicting subclinical vascular injury. Results The cohort included 49 patients with 92 leads extracted. A total of 25 patients (51%) had elastin‐positive leads. Complete procedural success occurred in 95.9% of cases. The multivariate regression model did not identify any independent predictors of elastin presence, including age (OR = 1.00; 95% CI 0.95–1.05; p = 0.89), female gender (OR = 3.04; 95% CI 0.67–13.65; p = 0.14), lead dwell time (OR = 1.13; 95% CI 0.98–1.29; p = 0.07). Additionally, no scoring system, such as the CCF, EROS, MB, SAFeTY, and LECOM, predicted the presence of elastin. Conclusion Subclinical venous injury was common following TLE, yet did not predict adverse clinical outcomes, reinforcing that TLE performed in experienced centers carries a favorable safety profile. Future studies in larger cohorts are needed to further characterize the clinical utility of subclinical vascular injury.
Catheter Ablation Versus Medical Therapy as First‐Line Treatment for Ventricular Electrical Storm: A Systematic Review and Meta‐Analysis
Sawalha, Khalid , Kusumoto, Fred, Alakchar, Mohammad , Sadeq, Ahmed A., Al-Akchar, Mohammad , Kusumoto, Fred , Goldsweig, Andrew M.

Journal of Cardiovascular Electrophysiology | December 9, 2025 | Volume: 37 | Issue: 2 | Pages: 305-312

10.1111/jce.70222 Get It

ABSTRACT Background Electrical storm (ES) is a life‐threatening manifestation of recurrent ventricular arrhythmia. While anti‐arrhythmic drugs (AADs) have historically been the first‐line treatment, the role of catheter ablation (CA) as an initial therapy in ES remains incompletely defined. This meta‐analysis evaluates the efficacy and safety of radiofrequency CA compared to escalating medical therapy in patients with ES. Methods A systematic search of PubMed, Science Direct, and Cochrane databases was conducted for studies published from 2010 to 2025 that compared CA with medical therapy as first‐line treatment for ES. Outcomes of interest included ES recurrence, ventricular arrhythmia recurrence, in‐hospital mortality, procedural complications, and follow‐up survival. Pooled odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using random‐effects models. Results Six studies encompassing 963 patients (473 CA, 490 medical therapy) were included. The mean age was 67.8 years, and 87.7% were male. The mean left ventricular ejection fraction was 33%, and ischemic cardiomyopathy was present in 77.5% of CA and 72.1% of MT patients. CA reduced the risk of ES recurrence by 71% compared to medical therapy (OR: 0.29; 95% CI: 0.15–0.53; p < 0.001; I ² = 53%). Recurrence of any ventricular arrhythmia, in‐hospital mortality, and long‐term survival were also significantly improved with CA. Conclusion This meta‐analysis suggests that CA is associated with lower ES and VA recurrence and in‐hospital mortality and improved survival compared to medical therapy alone. These findings support consideration of catheter ablation as a first‐line strategy. Larger prospective trials are needed to confirm these findings and guide patient selection.
Abstract 4364607: Clinical Impact of Proton Beam Radiation on Pacemakers and ICDs: Insights from the RADIATE-CIED Registry
Suppah, Mustafa , Mousa, Hana, Lee, Justin Z. , Schwartz, Linda, Harrington, Daniel P. , Shen, Win K., Cha, Yong‐Mei , Sorajja, Dan , Schwartz, Linda, Kusumoto, Fred

Circulation | November 3, 2025 | Volume: 152 | Issue: Suppl_3 | Pages: No page available

10.1161/circ.152.suppl_3.4364607 Get It

Background: Patients with cardiac implantable electronic devices (CIEDs) undergoing radiation therapy face potential risks of device malfunction. Proton beam therapy (PBT), with its reduced neutron scatter, has emerged as a potentially safer alternative, yet real-world safety data remain scarce. Methods: We conducted a retrospective cohort study of 100 patients with CIEDs (76 pacemakers, 24 ICDs) who underwent PBT from 2016 to 2023 at a quaternary center. Baseline and serial device interrogations were performed before, during, and after treatment to assess lead impedance, capture thresholds, battery function, and arrhythmic events. Patients were stratified by pacemaker dependence and monitored accordingly. Primary outcomes included device malfunction and new-onset arrhythmias during treatment. Secondary outcomes included device parameter changes, one-year arrhythmia incidence, and cardiac-related hospitalizations. Results: No treatment-related deaths or major device failures occurred. Device malfunction was rare (2 pacemaker patients, 2.6%), with no malfunctions in ICD recipients. Transient, non-clinically significant changes in lead impedance and capture thresholds were observed. Arrhythmias during treatment occurred in 26% of pacemaker and 25% of ICD patients, but only 4% developed new arrhythmias. At one year, device-related complications and cardiac outcomes remained comparable across groups. Independent predictors of arrhythmias during treatment included a higher radiation dose per fraction (OR 1.45; p=0.001), a longer treatment duration (OR 1.12; p=0.04), and a higher number of fractions (OR 1.20; p=0.01). Conclusion: Proton beam therapy appears safe in patients with CIEDs, with a low incidence of clinically significant device malfunctions or arrhythmias. These findings support the integration of PBT into routine practice for this population and underscore the importance of structured monitoring protocols and prospective guideline refinement.
ST-Segment Elevation in the Stress Laboratory
Galeano-Lovera, Santiago F. , Kusumoto, Fred, Allison, Thomas G. , Kusumoto, Fred

JAMA Internal Medicine | November 25, 2024 | Volume: 185 | Issue: 1 | Pages: 101

10.1001/jamainternmed.2024.2890 Get It

This case report describes a woman in her early 60s who went into cardiac arrest immediately after administration of an echocardiogram contrast agent.
Leadless Ultrasound-Based Cardiac Resynchronization Therapy
Kusumoto, Fred

JAMA Cardiology | July 31, 2024 | Volume: 9 | Issue: 10 | Pages: 880

10.1001/jamacardio.2024.2067 Get It

Abstract 11366: Retained Cardiac Implantable Electronic Device Fragments After Incomplete Extraction Do Not Adversely Affect Magnetic Resonance Imaging Quality or Safety
Austin, Christopher , Landolfo, Kevin , Parikh, Pragnesh , Kusumoto, Fred

Circulation | April 23, 2024 | Volume: 134 | Issue: suppl_1 | Pages: No page available

10.1161/circ.134.suppl_1.11366 Get It

Introduction: The prevalence of cardiac implantable electronic devices (CIED) is steadily increasing. Accordingly, the frequency of CIED extraction has also increased. Occasionally, safe retrieval of all CIED components is not feasabile and lead fragments are left behind. Little is known about the safety and diagnostic accuracy of MRI in patients with retained CIED fragments. Methods: Two hundred consecutive patients were identified as having undergone orthotopic heart transplantation (OHT) at our institution between April 2006 and December 2014. Chest x-rays immediately prior to OHT were reviewed for presence of CIED and chest x-rays immediately following OHT were reviewed for retained CIED fragments. MRI performed after OHT in patients with retained CIED fragments were inspected for image quality and procedural safety. The most recent chest x-ray in patients with retained CIED fragments subjected to MRI was reviewed for change in fragment position. Results: One hundred seventy-eight of 200 patients (89%) had CIED prior to OHT. All patients with CIED had surgical device extraction at the time of OHT. Of these, 29 patients (12%) had retained CIED fragments after OHT, the majority of which (23/29) were ICD coil fragments located in the superior vena cava, brachiocephalic or subclavian vein. Ten patients with retained CIED fragments underwent a total of 28 MRI after OHT. No patient safety issues were identified during MRI acquisition, and all MRI images were of diagnostic quality. There were no changes in the position of CIED fragments following MRI. Conclusions: Diagnostic MRI can be safely performed in patients with retained CIED fragments after incomplete device extraction. Adherence of the ICD coil to the vessel wall due to fibrosis has been well described and is a common impediment to complete device extraction. Retrieval of these fragments prior to MRI does not appear warranted given the demonstrated safety and preserved MRI image quality in this population.
Long‐term outcomes with abandoning versus extracting sterile leads: A 10‐year population‐based study
Lee, Justin Z. , Talaei, Fahimeh , Sorajja, Dan , Valverde, Arturo M. , Scott, Luis R. , Asirvatham, Samuel J. , Kusumoto, Fred , Mulpuru, Siva K. , Cha, Yong‐Mei , Tan, Min Choon , Valverde, Arturo, Asirvatham, Samuel J , Kusumoto, Fred M , Cha, Yong-Mei , Srivathsan, Komandoor

Pacing and Clinical Electrophysiology | March 16, 2024 | Volume: 47 | Issue: 5 | Pages: 626-634

10.1111/pace.14940 Get It

Abstract Background Long‐term outcomes of sterile lead management strategies of lead abandonment (LA) or transvenous lead extraction (TLE) remain unclear. Methods We performed a retrospective study of a population residing in southeastern Minnesota with follow‐up at the Mayo Clinic and its health systems. Patients who underwent LA or TLE of sterile leads from January 1, 2000, to January 1, 2011, and had follow‐up for at least 10 years or until their death were included. Results A total of 172 patients were included in the study with 153 patients who underwent LA and 19 who underwent TLE for sterile leads. Indications for subsequent lead extraction arose in 9.1% ( n = 14) of patients with initial LA and 5.3% ( n = 1) in patients with initial TLE, after an average of 7 years. Moreover, 28.6% of patients in the LA cohort who required subsequent extraction did not proceed with the extraction, and among those who proceeded, 60% had clinical success and 40% had a clinical failure. Subsequent device upgrades or revisions were performed in 18.3% of patients in the LA group and 31.6% in the TLE group, with no significant differences in procedural challenges (5.2% vs. 5.3%). There was no difference in 10‐year survival probability among the LA group and the TLE group ( p = .64). Conclusion An initial lead abandonment strategy was associated with more complicated subsequent extraction procedures compared to patients with an initial transvenous lead extraction strategy. However, there was no difference in 10‐year survival probability between both lead management approaches.
Predicting Major Adverse Events in Patients Undergoing Transcatheter Left Atrial Appendage Occlusion
Faridi, Kamil F. , Ong, Emily , Zimmerman, Sarah , Varosy, Paul D. , Hsu, Jonathan C. , Kusumoto, Fred , Mortazavi, Bobak J. , Minges, Karl E. , Pereira, Lucy, Lakkireddy, Dhanunjaya , Koutras, Christina, DENTON, B, Mobayed, Julie, Curtis, Jeptha P. , Ong, Emily L , Friedman, Daniel J , Hsu, Jonathan C , Kusumoto, Fred M , Mortazavi, Bobak J , Minges, Karl E , Lakkireddy, Dhanunjaya , Curtis, Jeptha P , Freeman, James V , Denton, Beth, Freeman, James V.

Circulation: Arrhythmia and Electrophysiology | February 23, 2024 | Volume: 17 | Issue: 4 | Pages: No page available

10.1161/circep.123.012424 Get It

BACKGROUND: The National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry (LAAO) includes the vast majority of transcatheter LAAO procedures performed in the United States. The objective of this study was to develop a model predicting adverse events among patients undergoing LAAO with Watchman FLX. METHODS: Data from 41 001 LAAO procedures with Watchman FLX from July 2020 to September 2021 were used to develop and validate a model predicting in-hospital major adverse events. Randomly selected development (70%, n=28 530) and validation (30%, n=12 471) cohorts were analyzed with 1000 bootstrapped samples, using forward stepwise logistic regression to create the final model. A simplified bedside risk score was also developed using this model. RESULTS: Increased age, female sex, low preprocedure hemoglobin, no prior attempt at atrial fibrillation termination, and increased fall risk most strongly predicted in-hospital major adverse events and were included in the final model along with other clinically relevant variables. The median in-hospital risk-standardized adverse event rate was 1.50% (range, 1.03%–2.84%; interquartile range, 1.42%–1.64%). The model demonstrated moderate discrimination (development C-index, 0.67 [95% CI, 0.65–0.70] and validation C-index, 0.66 [95% CI, 0.62–0.70]) with good calibration. The simplified risk score was well calibrated with risk of in-hospital major adverse events ranging from 0.26% to 3.90% for a score of 0 to 8, respectively. CONCLUSIONS: A transcatheter LAAO risk model using National Cardiovascular Data Registry and LAAO Registry data can predict in-hospital major adverse events, demonstrated consistency across hospitals and can be used for quality improvement efforts. A simple bedside risk score was similarly predictive and may inform shared decision-making.
Abstract 16419: Assessing the Evidence Base of Cardiology-Specific Oncology Guideline Recommendations: Implications for Health Policy
Jhawar, Nikita , Schneider, Artur , Kusumoto, Fred

Circulation | December 19, 2023 | Volume: 148 | Issue: Suppl_1 | Pages: No page available

10.1161/circ.148.suppl_1.16419 Get It

Introduction: Oncology societies have been contributing guidelines/recommendations to the limited yet growing body of literature in cardio-oncology. Research Questions: What are the levels of evidence (LOE) and classes of recommendation (COR) for cardiology-specific recommendations produced by major oncology societies? Methods: We reviewed cardiology-specific recommendations published by the American Society of Clinical Oncology (ASCO), American Society of Hematology (ASoH), NCCN (National Comprehensive Cancer Network), and European Society of Cardiology (ESC). LOE and COR were noted for each recommendation. Results: The US oncologic societies have made 81 cardiac-specific recommendations (ASCO: 54 (67%); ASoH: 14 (17%); NCCN; 13 (16%) (Tables 1-3). For ASCO, 26 (48%) were COR 1, 23 (43%) COR 2, and 5 (9%) COR 3 supported by LOE A (9%), LOE B (39%), and LOE C (52%). For ASoH, 1(8%) was COR 1, 11(85%) COR 2, and 1(8%) COR 3 supported by LOE B (7%), and LOE C (93%). NCCN made 13 COR 2 recommendations and did not provide LOE classification. The most common recommendations addressed baseline (20%) and serial (24%) assessment, specific imaging modalities (9%), chemotherapy dosing (19%), and radiation therapy (20%). Most recommendations were unique without discrepant statements, but there were some redundancies. ESC produced 271 cardio-oncology recommendations (155 COR 1; 111 COR 2; 5 COR-3) with 3% LOE A, 21% LOE B, and 76% LOE C. The major areas for ESC recommendations included baseline (18%) and serial (33%) assessment, and medications (29%). Conclusions: Oncology and cardiology professional society guidelines have provided 352 cardiac related recommendations in the setting of cancer treatment and 73% have the lowest LOE. In this developing field with a limited evidence base, close collaboration between cardiologists and oncologists will be required to provide a cohesive set of recommendations for the cardiac issues associated with cancer treatment.
Statement from the Asia Summit: Current state of arrhythmia care in Asia
Agbayani, Michael‐Joseph F., Choi, Jong‐Il , Dan, Van Buu , Hanafy, Dicky A, Hurwitz, Jodie L. , Kalman, Jonathan M. , Khan, Aamir Hameed H., Khmao, Pichmanil , Ngarmukos, Tachapong , Nguyen, Son Thai Binh, Nwe, Nwe, Soejima, Kyoko , Stiles, Martin K. , TSAO, HSUAN‐MING , Tseveendee, Saruul, Shimizu, Wataru , Kusumoto, Fred , Apiyasawat, Sirin , Chen, Ming-Long , Ching, Chi Keong , Hanafy, Dicky Armein , Johar, Sofian , Krahn, Andrew D. , Nwe, Nwe, Oh, Seil

Journal of Arrhythmia | September 27, 2023 | Volume: 40 | Issue: 1 | Pages: 1-16

10.1002/joa3.12935 Get It

AbstractOn May 27, 2022, the Asia Pacific Heart Rhythm Society and the Heart Rhythm Society convened a meeting of leaders from different professional societies of healthcare providers committed to arrhythmia care from the Asia Pacific region. The overriding goals of the meeting were to discuss clinical and health policy issues that face each country for providing care for patients with electrophysiologic issues, share experiences and best practices, and discuss potential future solutions. Participants were asked to address a series of questions in preparation for the meeting. The format of the meeting was a series of individual country reports presented by the leaders from each of the professional societies followed by open discussion. The recorded presentations from the Asia Summit can be accessed at https://www.heartrhythm365.org/URL/asiasummit‐22. Three major themes arose from the discussion. First, the major clinical problems faced by different countries vary. Although atrial fibrillation is common throughout the region, the most important issues also include more general issues such as hypertension, rheumatic heart disease, tobacco abuse, and management of potentially life‐threatening problems such as sudden cardiac arrest or profound bradycardia. Second, there is significant variability in the access to advanced arrhythmia care throughout the region because of differences in workforce availability, resources, drug availability, and national health policies. Third, collaboration in the area already occurs between individual countries, but no systematic regional method for working together is present.