Kusumoto, Fred

Background: Long-term outcomes of lead management strategies of lead abandonment (LA) or transvenous lead extraction (TLE) during cardiac implantable electronic devices (CIED) procedures requiring lead addition or replacement remain unclear. Hypothesis: We hypothesized that there is no difference in long-term (10-year) outcomes of LA versus TLE during CIED procedures requiring lead addition. Methods: We performed a retrospective cohort study of a population residing in seven adjacent counties of southeastern Minnesota with follow-up at the Mayo Clinic and its health systems. Patients who underwent LA or TLE for 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. Outcomes were identified through a detailed chart review of the electronic health record from within the Mayo Clinic system. 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. In long-term follow-up, 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, out of 14 patients, who required secondary extraction in the LA cohort, 28.6% did not proceed with the extraction. Of the remaining 10 patients, 60% had clinical success and 40% had a clinical failure with the extraction. 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 such as requiring balloon venoplasty or serial dilation (5.2% vs. 5.3%, P=1.0). There was no difference in 10-year survival probability among LA group and TLE group (P=0.64). Conclusion: Indications for subsequent extraction arose in 9.1% of patients with the initial LA approach for sterile leads after an average of 7.3 years and 28.6% did not proceed with the extraction. Of the patients who underwent the subsequent extraction, 60% had clinical success and 40% had a clinical failure. There was no difference in 10-year survival probability between patients with the initial LA approach or TLE approach.

Background and Objective: The published cardiology literature is critical for scientific communication, and we sought to determine if the published clinical cardiology evidence base has evolved over time. Methods: We evaluated the cardiology related publications in the medical journals (M) JAMA (J) and the New England Journal of Medicine (N) and all publications by the specialty journals (CA) Circulation (Ci) and the European Heart Journal (E) in 2000, 2010, and 2020 and added 2001, 2011, and 2021 for JAMA to account for potential annual variability. Results: Publication information is shown in the graph. For the M journals there has been an increase in the percentage of randomized controlled trials (RCT). For the CA journals there has been a significant decrease in single center studies (Si) and a proportionate increase in reanalysis (Re) of data whether from subanalysis of an RCT, registry, or meta-analysis. For CA journals there has been an increase in the size of clinical studies mainly due to the use of larger datasets from registries or claims (Ci: 2000: 4,500/study; 2010: 9,298/study; 2020: 258,725/study and E: 2000: 2,282/study; 2010: 12,652/study; 2020: 249,388/study). CA journals have an increased of studies with patients from multiple continents (Ci: 2000: 5.5%; 2010: 13%; 2020: 35% and E: 2000: 7%; 2010: 14.8%; 2020: 18.8%). There has been an increase in the percentage of clinical studies with documentation of different populations by region or color (In 2020, 58% for all Ci articles and 52% for US and multicontinental EHJ articles), although the number of nonwhites remains small in most studies unless the study was specifically addressing disparities in care. Conclusions: Over the last two decades, the published evidence base has changed with more RCT in the Med journals and more studies that reanalyze large datasets in CA journals. Published studies are now larger, more likely to involve multiple continents, and document population details.

Background: Recognition of the infectious characteristics among the sepsis-related early mortality after transvenous lead removal (TLR) is an essential step to improving patient outcomes. Objective: This study sought to understand the infectious characteristic and circumstances among the sepsis-related early mortality after TLR. Methods: We performed a retrospective analysis of all patients undergoing TLR from January 1, 2001, to January 1, 2021 at the Mayo Clinic (Rochester, Phoenix, and Jacksonville). Patient details were identified through a detailed chart review of the electronic health record from within the Mayo Clinic system and outside records when available. Results: A total of 2,319 patients were included in the study. The overall 30-day sepsis-related mortality rate was 1.25% (n=29). Among the sepsis-related deaths, 24 patients (83%) had systemic cardiac implantable electronic device (CIED) infection, and 4 patients (14%) initially had isolated pocket infection. The average time from admission to TLR was 11 days. MSSA was the most common organism (n=8, 28%), and this was followed by MRSA (n=4, 14%) and Candida (n=3, 10%). Twenty of these patients (69%) had vegetation on the echocardiogram: vegetation on lead only in 9 patients, vegetation on both valve and lead in 8 patients, and vegetation on valve only in 3 patients. Among valvular vegetations, 5 patients had tricuspid valve vegetations, 3 patients had aortic valve vegetations, 2 patients had mitral valve vegetations, and 1 patient had both mitral and aortic valve vegetation. The average size of vegetation was 1.3±0.8 x 1.1±0.6 cm. Conclusions: The 30-day sepsis-related mortality rate was 1.25%. Among the sepsis-related early deaths, MSSA was the most common organism, and more than two-thirds (69%) of the patients had vegetations on cardiac imaging. This highlights the importance of further research to improve the infection outcome in TLR patients.

Background: Recognition of the causes of early mortality after transvenous lead removal (TLR) is an essential step for the development of quality improvement programs. Objective: This study sought to determine the causes of early mortality after TLR and to further understand the circumstances surrounding death after TLR. Methods: We performed a retrospective analysis of all patients undergoing TLR from January 1, 2001, to January 1, 2021 at the Mayo Clinic (Rochester, Phoenix, and Jacksonville). Causes of death were identified through a detailed chart review of the electronic health record from within the Mayo Clinic system and outside records when available. The causes of death were further characterized based on whether it was related to the TLR procedure. Results: A total of 2,319 patients were included in the study. The overall 30-day all-cause mortality rate was 3%. Among all 30-day deaths, infection was the most common primary cause of death (42%). This was followed by decompensated heart failure (17%), procedure-related death (10%), sudden cardiac arrest (7%), and respiratory failure (6%). The 30-day mortality rate directly due to complications associated with the TLR procedure was 0.3% due to vascular tear and cardiac perforation. A third of deaths (33%) occurred after discharge from index hospitalization, among which 43% were readmitted before their death, 35% died at home or a nursing facility, and 22% were discharged on comfort care and died in hospice. The main reasons for readmission prior to death were sepsis and decompensated heart failure. Conclusions: The majority (90%) of 30-day mortality after TLR was not due to complications associated with TLR procedures. The primary causes were infection and decompensated heart failure. This highlights the importance of further research to reduce postoperative mortality from these factors, including deaths after hospital discharge.

Background: Atypical Atrial Flutter (AAFL) prevalence is increasing due to the escalating Atrial Fibrillation (AF) ablations and cardiac surgeries. We wanted to explore the outcome of the AAFL ablation, considering the recent changes in mapping and ablation. Methods: This study was approved by the Institutional Review Board (IRB) of Mayo Clinic hospital. We retrospectively studied 419 patients who had undergone AAFL ablation at Mayo Clinic from January 2017 to June 2022. Thirteen patients declined research authorization, and 19 patients were lost to follow-up during the 90-day blanking period, resulting in a sample size of 387. The median follow-up time for patients was 25.7 months (95% CI 23.7, 32.3). Results: Recurrent symptoms with documentation of atrial arrhythmia Occurred in 226/387 (58.4%) patients, of which 151/226 (66.8%) occurred within the first year. The median time to recurrence was 8.5 months (max 57.8 months). Eleven patients died during the study period, 9 of whom experienced recurrence prior to death. Overall, the median recurrence-free survival (RFS) time was 16.6 months (95% CI 13.2, 20.0) with a 1-year RFS rate of 57.2% (95% CI 52.2, 62.7%). Acute termination occurred 324/387 (83.7%) during the ablation. The 1-year RFS rate was 58.9% (95% CI 53.5%, 64.9%) for patients with acute termination and 49.0% (95% CI 37.9%, 63.4%) for those without acute termination. The rate was not significantly different based on acute termination status (p = 0.11). Conclusions: The one-year RFS rate of 57.2% following AAFL ablation, even though 83.7% achieved acute termination during the procedure, signifies the extent of the underlying substrate abnormalities.

AbstractBackgroundThe incidence and impact of noise in a subcutaneous implantable cardioverter defibrillator (S‐ICD) after left ventricular assist device (LVAD) implantation is not well established.MethodsWe performed a retrospective study of patients implanted with LVAD and with a pre‐existing S‐ICD between January 2005 and December 2020 at the three Mayo Clinic centers (Minnesota, Arizona, and Florida).ResultsOf the 908 LVAD patients, a pre‐existing S‐ICD was present in 9 patients (mean age 49.1 ± 13.7 years, 66.7% males), 100% with Boston Scientific third‐generation EMBLEM MRI S‐ICD, 11% with HeartMate II (HM II), 44% with HeartMate 3 (HM 3), and 44% with HeartWare (HW) LVAD. The incidence of noise from LVAD‐related electromagnetic interference (EMI) was 33% and was only seen with HM 3 LVAD. Multiple measures attempted to resolve noise, including using alternative S‐ICD sensing vector, adjusting S‐ICD time zone, and increasing LVAD pump speed, were unsuccessful, necessitating S‐ICD device therapies to be turned off permanently.ConclusionsThe incidence of LVAD‐related S‐ICD noise is high in patients with concomitant LVAD and S‐ICD with significant impact on device function. As conservative management failed to resolve the EMI, the S‐ICDs had to be programmed off to avoid inappropriate shocks. This study highlights the importance of awareness of LVAD‐SICD device interference and the need to improve S‐ICD detection algorithms to eliminate noise.

A previously healthy person in their 60s with progressive shortness of breath and fatigue for the past 6 months presented to the emergency department with palpitations and shortness of breath. What is your diagnosis?

Background: The Food and Drug Administration approved left atrial appendage occlusion with the Watchman device for patients who are at increased stroke risk and are suitable for oral anticoagulation but who have an appropriate reason to seek a nondrug alternative. These broad criteria raise the question of their interpretation in clinical practice. There is a lack of studies comprehensively evaluating the indications for Watchman implantation among a large series of patients from contemporary, real-world practice in the United States. Methods: We used the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry to identify Watchman procedures performed between 2016 and 2018. We assessed procedural indications for Watchman implantation in the United States and evaluated the association between procedural indications and in-hospital adverse events. Results: A total of 38 314 procedures were included. The mean patient age was 76.1±8.1 years, and 58.9% were men. The mean CHA 2 DS 2 -VASc score was 4.8±1.5, whereas the mean hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol (HAS-BLED) score was 3.0±1.1. Prior stroke or transient ischemic attack was reported in 40.2% and prior bleeding in 70.1%, with gastrointestinal bleeding being most common (41.9%). The most common site-reported procedural indications for Watchman implantation were increased thromboembolic risk (64.8%) and history of major bleed (64.3%), followed by high fall risk (35.5%). Most (71.9%) had ≥2 procedural indications. Patients with high fall risk had increased risk of in-hospital adverse events (adjusted OR, 1.12; P =0.025), but no other differences were found in the risk of in-hospital adverse events by procedural indication. Conclusions: Among patients in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry, the most common procedural indications for Watchman implantation were increased thromboembolic risk, history of major bleed, and high fall risk. A majority of patients had multiple procedural indications. High fall risk conferred a modestly increased risk of in-hospital adverse events.