Adverse Events in Total Artificial Heart for End-Stage Heart Failure: Insight From the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE).

Background and Objectives: Real-world clinical data, outside of clinical trials and expert centers, on adverse events related to the use of SyncCardia total artificial heart (TAH) remain limited. We aim to analyze adverse events related to the use of SynCardia TAH reported to the Food and Drug Administration (FDA)'s Manufacturers and User Defined Experience (MAUDE) database. Methods: We reviewed the FDA's MAUDE database for any adverse events involving the use of SynCardia TAH from 1/01/2012 to 9/30/2020. All the events were independently reviewed by three physicians. Results: A total of 1,512 adverse events were identified in 453 "injury and death" reports in the MAUDE database. The most common adverse events reported were infection (20.2%) and device malfunction (20.1%). These were followed by bleeding events (16.5%), respiratory failure (10.1%), cerebrovascular accident (CVA)/other neurological dysfunction (8.7%), renal dysfunction (7.5%), hepatic dysfunction (2.2%), thromboembolic events (1.8%), pericardial effusion (1.8%), and hemolysis (1%). Death was reported in 49.4% of all the reported cases (n=224/453). The most common cause of death was multiorgan failure (n=73, 32.6%), followed by CVA/other non-specific neurological dysfunction (n=44, 19.7%), sepsis (n=24, 10.7%), withdrawal of support (n=20, 8.9%), device malfunction (n=11, 4.9%), bleeding (n=7, 3.1%), respiratory failure (n=7, 3.1%), gastrointestinal disorder (n=6, 2.7%), and cardiomyopathy (n=3, 1.3%). Conclusions: Infection was the most common adverse event following the implantation of TAH. Most of the deaths reported were due to multiorgan failure. Early recognition and management of any possible adverse events after the TAH implantation are essential to improve the procedural outcome and patient survival.

Rural-urban stroke mortality gaps in the United States.

INTRODUCTION: Disparities in stroke outcomes, influenced by the use of systemic thrombolysis, endovascular therapies, and rehabilitation services, have been identified. Our study assesses these disparities in mortality after stroke between rural and urban areas across the United States (US). METHODS: We analyzed the CDC data on deaths attributed to cerebrovascular disease from 1999 to 2020. Data was categorized into rural and urban regions for comparative purposes. Age-adjusted mortality rates (AAMR) were computed using the direct method, allowing us to examine the ratios of rural to urban deaths for the cumulative population and among demographic subpopulations. Linear regression models were used to assess temporal changes in mortality ratios over the study period, yielding beta-coefficients (ß). RESULTS: There was a total of 628,309 stroke deaths in rural regions and 2,556,293 stroke deaths within urban regions. There were 1.13 rural deaths for each one urban death per 100,000 population in 1999 and 1.07 in 2020 (ß = -0.001, ptrend = 0.41). The rural-urban mortality ratio in Hispanic populations decreased from 1.32 rural deaths for each urban death per 100,000 population in 1999 to 0.85 in 2020 (ß = -0.011, ptrend < 0.001). For non-Hispanic populations, mortality remained stagnant with 1.12 rural deaths for each urban death per 100,000 population in 1999 and 1.07 in 2020 (ß = -0.001, ptrend = 0.543). Regionally, the Southern US exhibited the highest disparity with a urban-rural mortality ratio of 1.19, followed by the Northeast (1.13), Midwest (1.04), and West (1.01). CONCLUSIONS: Our findings depict marked disparities in stroke mortality between rural and urban regions, emphasizing the importance of targeted interventions to mitigate stroke-related disparities.

Trends and Disparities in Valvular Heart Disease Mortality in the United States From 1999 to 2020.

BACKGROUND: Percutaneous heart valve procedures have been increasingly performed over the past decade, yet real-world mortality data on valvular heart disease (VHD) in the United States remain limited. METHODS AND RESULTS: We queried the Centers for Disease Control and Prevention's Wide-Ranging Online Data for Epidemiologic Research database among patients ≥15 years old from 1999 to 2020. VHD and its subtypes were listed as the underlying cause of death. We calculated age-adjusted mortality rate (AAMR) per 100 000 individuals and determined overall trends by estimating the average annual percent change using the Joinpoint regression program. Subgroup analyses were performed based on demographic and geographic factors. In the 22-year study, there were 446 096 VHD deaths, accounting for 0.80% of all-cause mortality (56 014 102 people) and 2.38% of the total cardiovascular mortality (18 759 451 people). Aortic stenosis recorded the highest mortality of VHD-related death in both male (109 529, 61.74%) and female (166 930, 62.13%) populations. The AAMR of VHD has declined from 8.4 (95% CI, 8.2-8.5) to 6.6 (95% CI, 6.5-6.7) per 100 000 population. Similar decreasing AAMR trends were also seen for the VHD subtypes. Men recorded higher AAMR for aortic stenosis and aortic regurgitation, whereas women had higher AAMR for mitral stenosis and mitral regurgitation. Mitral regurgitation had the highest change in average annual percent change in AAMR. CONCLUSIONS: The mortality rate of VHD among the US population has declined over the past 2 decades. This highlights the likely efficacy of increasing surveillance and advancement in the management of VHD, resulting in improved outcomes.

Impact of age on hospital outcomes after catheter ablation for ventricular tachycardia.

Background: The real-world data on the safety profile of ventricular tachycardia (VT) ablation among elderly patients is not well-established. This study aimed to evaluate the procedural outcomes among those aged 18-64 years versus those aged ≥65 years who underwent catheter ablation of VT. Method: Using the Nationwide Readmissions Database, our study included patients aged ≥18 years who underwent VT catheter ablation between 2017 and 2020. We divided the patients into non-elderly (18-64 years old) and elderly age groups (≥65 years old). We then analyzed the in-hospital procedural outcome and 30-day readmission between these two groups. Results: Our study included 2075 (49.1%) non-elderly patients and 2153 (50.9%) elderly patients who underwent VT ablation. Post-procedurally, elderly patients had significantly higher rates of prolonged index hospitalization (≥7 days; 35.5% vs. 29.3%, p < .01), non-home discharge (13.4% vs. 6.0%, p < .01), 30-day readmission (17.0% vs. 11.4%, p < .01), and early mortality (5.5% vs. 2.4%, p < .01). There was no significant difference in the procedural complications between two groups, namely vascular complications, hemopericardium/cardiac tamponade, cerebrovascular accident (CVA), major bleeding requiring blood transfusion, and systemic embolization. Through multivariable analysis, the elderly group was associated with higher odds of early mortality (OR: 7.50; CI 1.86-30.31, p = .01), non-home discharge (OR: 2.41; CI: 1.93-3.00, p < .01) and 30-day readmission (OR: 1.58; CI 1.32-1.89, p < .01). Conclusion: Elderly patients have worse in-hospital outcome, early mortality, non-home discharge, and 30-day readmission following catheter ablation for VT. There was no significant difference between elderly and non-elderly groups in the procedural complications.

Trends in comorbid chronic kidney disease and atrial fibrillation-related cardiovascular mortality in the United States.

Background: The impact of chronic kidney disease (CKD) on atrial fibrillation outcomes (AF) is not well understood. Methods: We conducted analyses of comorbid AF and CKD related death in the United States from 1999 to 2020 using descriptive epidemiology. Results: Age-adjusted mortality rates (AAMR) per 100,000 increased from 0.39 in 1999 to 1.65 in 2020. Non-Hispanic populations (1.01) and nonmetropolitan areas (1.08) had higher AAMRs compared to Hispanic (0.62) and metropolitan (0.97) areas. Midwestern (1.11) and Western (1.13) US regions recorded the highest AAMRs. Conclusions: These findings highlight the need for interventions to address AF death disparities in patients with CKD.

Electrical storm after left ventricular assist device (LVAD) implantation.

INTRODUCTION: Ventricular tachycardia storm or electrical storm (ES) is a common complication following left ventricular assist device (LVAD) implantation. The factors contributing to ES and outcomes are less studied. The study aimed to determine the factors associated with ES and the probability of survival in patients undergoing LVAD in three tertiary centers over a span of 15 years. METHODS: We performed a retrospective cohort study on all patients who underwent LVAD implantation at the Mayo Clinic (Rochester, Phoenix, and Jacksonville) from January 1, 2006 to December 31, 2020. ES was defined as ≥3 episodes of sustained ventricular tachycardia over a period of 24 h with no identifiable reversible cause. Detailed chart reviews of the electronic health records within the Mayo Clinic and outside medical records were performed. RESULTS: A total of 883 patients who underwent LVAD implantation were included in our study. ES occurred in 7% (n = 61) of patients with a median of 13 days (interquartile range [IQR]: 5-297 days) following surgery. We found 57% of patients (n = 35) developed ES within 30 days, while 43% (n = 26) patients developed ES at a median of 545  (IQR 152-1032) days after surgery. Following ES, 26% of patients died within 1 year. Patients with ES had a significant association with a history of ventricular arrhythmias and implantable cardioverter defibrillator (ICD) shocks before the procedure. ES was significantly associated with reduced survival compared to patients without ES (hazards ratio [HR]: 1.92, 95% CI: 1.39-2.64, p < .001). CONCLUSION: Following LVAD implantation, the rate of ES was 7% with majority of ES occurring within 30 days of LVAD. Risk factors for ES included pre-implant history of ventricular arrhythmias and ICD shock. ES was significantly associated with reduced survival compared to patients without ES.

Trends and Disparities in Cardiovascular Death in Sarcoidosis: A Population-Based Retrospective Study in the United States From 1999 to 2020.

BACKGROUND: Despite significant cardiac involvement in sarcoidosis, real-world data on death due to cardiovascular disease among patients with sarcoidosis is not well established. METHODS AND RESULTS: We queried the Centers for Disease Control and Prevention's Wide-Ranging Online Data for Epidemiologic Research database for data on patients with sarcoidosis aged ≥25 years from 1999 to 2020. Diseases of the circulatory system except ischemic heart disease were listed as the underlying cause of death, and sarcoidosis was stated as a contributing cause of death. We calculated age-adjusted mortality rate (AAMR) per 1 million individuals and determined the trends over time by estimating the annual percentage change using the Joinpoint Regression Program. Subgroup analyses were performed on the basis of demographic and geographic factors. In the 22-year study period, 3301 cardiovascular deaths with comorbid sarcoidosis were identified. The AAMR from cardiovascular deaths with comorbid sarcoidosis increased from 0.53 (95% CI, 0.43-0.65) per 1 million individuals in 1999 to 0.87 (95% CI, 0.75-0.98) per 1 million individuals in 2020. Overall, women recorded a higher AAMR compared with men (0.77 [95% CI, 0.74-0.81] versus 0.58 [95% CI, 0.55-0.62]). People with Black ancestry had higher AAMR than people with White ancestry (3.23 [95% CI, 3.07-3.39] versus 0.39 [95% CI, 0.37-0.41]). A higher percentage of death was seen in the age groups of 55 to 64 years in men (23.11%) and women (21.81%), respectively. In terms of US census regions, the South region has the highest AAMR from cardiovascular deaths with comorbid sarcoidosis compared with other regions (0.78 [95% CI, 0.74-0.82]). CONCLUSIONS: The increase of AAMR from cardiovascular deaths with comorbid sarcoidosis and higher cardiovascular mortality rates among adults aged 55 to 64 years highlight the importance of early screening for cardiovascular diseases among patients with sarcoidosis.

Long-term outcomes with abandoning versus extracting sterile leads: A 10-year population-based study.

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.

Impact of infective versus sterile transvenous lead removal on 30-day outcomes in cardiac implantable electronic devices.

BACKGROUND: Transvenous lead removal (TLR) is associated with increased mortality and morbidity. This study sought to evaluate the impact of TLR on in-hospital mortality and outcomes in patients with and without CIED infection. METHODS: From January 1, 2017, to December 31, 2020, we utilized the nationally representative, all-payer, Nationwide Readmissions Database to assess patients who underwent TLR. We categorized TLR as indicated for infection, if the patient had a diagnosis of bacteremia, sepsis, or endocarditis during the initial admission. Conversely, if none of these conditions were present, TLR was considered sterile. The impact of infective vs sterile indications of TLR on mortality and major adverse events was studied. RESULTS: Out of the total 25,144 patients who underwent TLR, 14,030 (55.8%) received TLR based on sterile indications, while 11,114 (44.2%) received TLR due to device infection, with 40.5% having systemic infection and 59.5% having isolated pocket infection. TLR due to infective indications was associated with a significant in-hospital mortality (5.59% vs 1.13%; OR = 5.16; 95% CI 4.33-6.16; p < 0.001). Moreover, when compared with sterile indications, TLR performed due to device infection was associated with a considerable risk of thromboembolic events including pulmonary embolism and stroke (OR = 3.80; 95% CI 3.23-4.47, p < 0.001). However, there was no significant difference in the conversion to open heart surgery (1.72% vs. 1.47%, p < 0.111), and infection was not an independent predictor of cardiac (OR = 1.12; 95% CI 0.97-1.29) or vascular complications (OR = 1.12; 95% CI 0.73-1.72) between the two groups. CONCLUSION: Higher in-hospital mortality and rates of thromboembolic events associated with TLR resulting from infective indications may warrant further pursuing this diagnosis in patients.

Effect of age on in-hospital outcomes of transvenous lead extraction for infected cardiac implantable electronic device.

BACKGROUND: The real-world data on the safety profile of transvenous lead extraction (TLE) for infected cardiac implantable electronic devices (CIED) among elderly patients is not well-established. This study aimed to evaluate the hospital outcomes between patients of different age groups who underwent TLE for infected CIED. METHOD: Using the Nationwide Readmissions Database, our study included patients aged ≥18 years who underwent TLE for infected CIED between 2017 and 2020. We divided the patients into four groups: Group A. Young (<50 years), Group B. Young intermediate (50-69 years old), Group C. Older intermediate (70-79 years old), and Group D. Octogenarian (≥80 years old). We then analyzed the in-hospital outcome and 30-day readmission between these age groups. RESULTS: A total of 10,928 patients who were admitted for TLE of infected CIED were included in this study: 982 (9.0%) patients in group A, 4,234 (38.7%) patients in group B, 3,204 (29.3%) patients in group C and 2,508 (23.0%) of patients in group D. Our study demonstrated that the risk of early mortality increased with older age (Group B vs. Group A: OR: 1.92, 95% CI: 1.19-3.09, p < .01; Group C vs. Group A: OR: 2.47, 95% CI: 1.51-4.04, p < .01; Group D vs. Group A: OR: 2.82, 95% CI: 1.69-4.72, p < .01). The risk of non-home discharge also increased in elderly groups (Group B vs. Group A: OR: 1.89; 95% CI: 1.52-2.36; p < .01; Group C vs. Group A: OR: 2.82; 95% CI 2.24-3.56; p < .01; Group D vs. Group A: OR: 4.16; 95% CI: 3.28-5.28; p < .01). There was no significant difference in hospitalization length and 30-day readmission between different age groups. Apart from a higher rate of open heart surgery in group A, the procedural complications were comparable between these age groups. CONCLUSION: Elderly patients had worse in-hospital outcomes in early mortality and non-home discharge following the TLE for infected CIED. There was no significant difference between elderly and non-elderly groups in prolonged hospital stay and 30-day readmission. Elderly patients did not have a higher risk of procedural complications.

Thirty-day readmission after catheter ablation for ventricular tachycardia: associated factors and outcomes.

BACKGROUND: Patients with ventricular tachycardia (VT) who require VT ablation are at high risk for readmission. This study aimed to identify the causes and outcomes of 30-day readmission after VT ablation and to analyze the predictors of recurrent VT that required rehospitalization. METHODS: Using the Nationwide Readmission Database, our study included patients aged ≥ 18 years who underwent VT catheter ablation between 2017 and 2020. Based on the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), we identified the causes of 30-day readmission by organ systems and analyzed their outcomes. Additional analysis was performed to determine the independent predictors of 30-day readmission for recurrent VT. RESULTS: Of the 4228 patients who underwent VT ablation, 14.2% were readmitted within 30 days of the procedure. The most common cause of readmission was cardiac events (73.6%). Among the cardiac-related readmissions, recurrent VT (47.7%) and congestive heart failure (CHF) (12.9%) were the most common etiologies. Among the readmissions, patients readmitted for CHF had the highest rate of readmission mortality (9.2%). Of the patients readmitted within 30 days of the procedure, 278 patients (6.8%) were readmitted for recurrent VT. Via multivariable analysis, CHF (OR: 1.97; 95% CI: 1.12-3.47; P = 0.02) and non-elective index admissions (OR: 1.63; 95% CI: 1.04-2.55; P = 0.03) were identified as the independent predictors predictive of 30-day readmissions for recurrent VT. CONCLUSIONS: Recurrent VT was the most common cause of readmission after the VT ablation procedure, and CHF and non-elective index admissions were the significant predictors of these early readmissions. Readmission due to CHF had the highest mortality rate during readmission.

Mortality trends, disparities, and social vulnerability in cardiac arrest mortality in the young: A cross-sectional analysis.

BACKGROUND: Cardiac arrest (CA) is a leading cause of death in the United States (US). Social determinants of health may impact CA outcomes. We aimed to assess mortality trends, disparities, and the influence of the social vulnerability index (SVI) on CA outcomes in the young. METHODS: We conducted a cross-sectional analysis of age-adjusted mortality rates (AAMRs) related to CA in the United States from the Years 1999 to 2020 in individuals aged 35 years and younger. Data were obtained from death certificates and analyzed using log-linear regression models. We examined disparities in mortality rates based on demographic variables. We also explored the impact of the SVI on CA mortality. RESULTS: A total of 4792 CA deaths in the young were identified. Overall AAMR decreased from 0.20 in 1999 to 0.14 in 2020 with an average annual percentage change of -1.3% (p = .001). Black (AAMR: 0.30) and male populations (AAMR: 0.14) had higher AAMR compared with White (AAMR: 0.11) and female (AAMR: 0.11) populations, respectively. Nonmetropolitan (AAMR: 0.29) and Southern (AAMR: 0.26) regions were also impacted by higher AAMR compared with metropolitan (AAMR: 0.11) and other US census regions, respectively. A higher SVI was associated with greater mortality risks related to CA (risk ratio: 1.82 [95% CI, 1.77-1.87]). CONCLUSIONS: Our analysis of CA in the young revealed disparities based on demographics, with a decline in AAMR from 1999 to 2020. There is a correlation between a higher SVI and increased CA mortality risk, highlighting the importance of targeted interventions to address these disparities effectively.

Atrial fibrillation mortality trends in individuals with heart failure.

Atrial fibrillation (AF) frequently occurs concurrently with heart failure (HF). The two conditions can exacerbate each other, resulting in higher morbidity and mortality. In our analysis, we evaluated mortality trends related to AF in individuals with underlying HF. Cross-sectional analyses were performed using publicly available data from the Center for Disease Control and Prevention database to compare AF-related age-adjusted mortality rates across age, gender, racial/ethnic, and geographic subgroups. Mortality trends were evaluated by fitting log-linear regression models followed by calculation of the average annual percentage change (AAPC) using the Monte Carlo permutation test. We identified a total of 55,917 deaths within the United States from AF with comorbid HF between 1999 and 2020. Males, older adults, White populations, and non-metropolitan regions had higher age-adjusted mortality compared to females, younger adults, Black populations, and metropolitan regions, respectively. The AAPC among younger adults was significantly higher compared to older adults. Our results demonstrate existing disparities among age, gender, racial, and geographic subgroups related to AF mortality among individuals with comorbid HF. Although decreased overall mortality was observed within younger populations compared to older populations, the prominent AAPC seen in younger populations warrants further investigation. Detection of AF among younger adults with comorbid HF should prompt the intensification of preventative and treatment measures.

Exploring Heart Failure Mortality Trends and Disparities in Women: A Retrospective Cohort Analysis.

Heart failure (HF) remains a significant cause of morbidity and mortality in women. Population-level analyses shed light on existing disparities and promote targeted interventions. We evaluated HF-related mortality data in women in the United States to identify disparities based on race/ethnicity, urbanization level, and geographic region. We conducted a retrospective cohort analysis utilizing the Centers for Disease Control and Prevention Wide-ranging Online Data for Epidemiologic Research database to identify HF-related mortality in the death files from 1999 to 2020. Age-adjusted HF mortality rates were standardized to the 2000 US population. We fit log-linear regression models to analyze mortality trends. Age-adjusted HF mortality rates in women have decreased significantly over time, from 97.95 in 1999 to 89.19 in 2020. Mortality mainly downtrended from 1999 to 2012, followed by a significant increase from 2012 to 2020. Our findings revealed disparities in mortality rates based on race and ethnicity, with the most affected population being non-Hispanic Black (age-adjusted mortality rates [AAMR] 90.36), followed by non-Hispanic White (AAMR 83.25), American Indian/Alaska Native (AAMR 64.27), and Asian/Pacific Islander populations (AAMR 37.46). We also observed that nonmetropolitan (AAMR 103.36) and Midwestern (AAMR 90.45) regions had higher age-adjusted mortality rates compared with metropolitan (AAMR 78.43) regions and other US census regions. In conclusion, significant differences in HF mortality rates were observed based on race/ethnicity, urbanization level, and geographic region. Disparities in HF outcomes persist and efforts to reduce HF-related mortality rates should focus on targeted interventions that address social determinants of health, including access to care and socioeconomic status.

Intracerebral hemorrhage mortality in individuals with atrial fibrillation: a nationwide analysis of mortality trends in the United States.

BACKGROUND: Atrial fibrillation (AF) is a risk factor for intracerebral hemorrhage (ICH), both with and without use of anticoagulation. Limited data exists on mortality trends and disparities related to this phenomenon. We aimed to assess ICH mortality trends and disparities based on demographic factors in individuals with atrial fibrillation in the United States (US). METHODS: Our cross-sectional analysis utilized mortality data from the CDC database through death certificate queries from the years 1999 to 2020 in the US. We queried for all deaths with ICH as the underlying cause of death and atrial fibrillation as the multiple causes of death. Mortality data was obtained for overall population and demographic subpopulations based on sex, race and ethnicity, and geographic region. Trend analysis and average annual-mortality percentage change (AAPC) were completed using log-linear regression models. RESULTS: ICH age-adjusted mortality rate (AAMR) in patients with AF increased from 0.27 (95% CI 0.25-0.29) in 1999 to 0.30 (95% CI 0.29-0.32) in 2020. A higher mortality rate was observed in males (AAMR 0.33) than in females (AAMR 0.26). The highest mortality was found in Asian/Pacific Islander (AAMR: 0.32) populations, followed by White (AAMR: 0.30), Black (AAMR: 0.15), and American Indian/Alaska Native (AAMR: 0.11) populations. Southern (AAPC: 1.3%) and non-metropolitan US regions (AAPC: + 1.9%) had the highest increase in annual mortality change. CONCLUSION: Our findings highlight the disparities in ICH mortality in patients with AF. Further investigation is warranted to confirm these findings and evaluate for contributors to the observed disparities.

Adverse events in cryoballoon ablation for pulmonary vein isolation: Insight from the Food and Drug Administration Manufacturer and User Facility Device Experience.

Background: Real-world clinical data on the adverse events related to the use of cryoballoon catheter for pulmonary vein isolation remains limited. Objective: To report and describe the adverse events related to the use of Artic Front cryoballoon catheters (Arctic Front, Arctic Front Advance, and Arctic Front Advance Pro) reported in the Food and Drug Administration's (FDA) Manufacturers and User Defined Experience (MAUDE) database. Methods: We reviewed all the adverse events reported to the FDA MAUDE database over a 10.7-year study period from January 01, 2011 to September 31, 2021. All events were independently reviewed by two physicians. Results: During the study period, a total of 320 procedural-related adverse events reported in the MAUDE database were identified. The most common adverse event was transient or persistent phrenic nerve palsy (PNP), accounting for 48% of all events. This was followed by cardiac perforation (15%), pulmonary vein stenosis (8%), transient ischemic attack or stroke (6%), vascular injury (4%), transient or persistent ST-elevation myocardial infarction (3%), hemoptysis (2%), pericarditis (2%), and esophageal ulcer or fistula (1%). There were six reported intra-procedural death events as a result of cardiac perforation. Conclusion: The two most common procedural adverse events associated with cryoballoon ablation were PNP and cardiac perforation. All cases of procedural mortality were due to cardiac perforation.

A Systematic Review of Short-Term Outcomes of Leadless Pacemaker Implantation After Transvenous Lead Removal of Infected Cardiac Implantable Electronic Device.

The outcomes of leadless pacemaker (LP) implantation after transvenous lead removal (TLR) of infected cardiac implantable electronic devices (CIEDs) are not well-established. This study sought to describe the outcomes of LP implantation after TLR of infected CIED. We conducted a literature search using PubMed and Embase for a combination of terms including LP implantation, transvenous lead extraction, TLR, transvenous lead explant, infected CIED, infected pacemaker, and infected implantable cardioverter defibrillator. The inclusion criterion was LP implantation after TLR of infected CIED. The exclusion criterion was TLR for noninfectious reasons. Study end points included procedural complications and LP infection during follow-up. Of 132 publications reviewed, 13 studies with a total of 253 patients (74 ± 14 years of age, 174 [69%] males) were included. The most common indication of the initial device implantations was a high-degree atrioventricular block (n = 100 of 253, 39.5%). Of the 253 patients included, 105 patients (41.5%) underwent concomitant LP implantation during the TLR procedure, and 36 patients (14.2%) had temporary transvenous pacing as a bridge from TLR to LP implantation. Of the 148 patients with data on the type of CIED infection, 56.8% had systemic CIED infection and 43.2% had isolated pocket infection. Staphylococcus aureus was the most common causative organism in 33% of the reported patients. The LP was implanted an average of 5.4 ± 10.7 days after TLR of infected CIED. During the LP implantation, 1 patient (0.4%) had unsuccessful implantation because of an intraprocedural complication requiring sternotomy. After LP implantation, 2 patients (0.8%) developed groin hematoma, 2 patients (0.8%) developed femoral arteriovenous fistula, and 1 patient (0.4%) developed pericardial effusion requiring pericardiocentesis. During a mean follow-up of 11.3 ± 10.6 months, 3 patients (1.2%) developed pacemaker syndrome, 1 patient (0.4%) developed acute on chronic heart failure exacerbation, and only 1 patient (0.4%) developed LP-related infection requiring LP retrieval. This study suggests that LP implant is feasible and safe after removal of infected CIED with cumulative adverse events at 4% and a reinfection rate of 0.4%. Large prospective studies are needed to better evaluate the best timing of LP implantation after TLR of an infected CIED.