Adverse events following COVID-19 mRNA vaccines: A systematic review of cardiovascular complication, thrombosis, and thrombocytopenia.

BACKGROUND AND OBJECTIVES: Since publishing successful clinical trial results of mRNA coronavirus disease 2019 (COVID-19) vaccines in December 2020, multiple reports have arisen about cardiovascular complications following the mRNA vaccination. This study provides an in-depth account of various cardiovascular adverse events reported after the mRNA vaccines' first or second dose including pericarditis/myopericarditis, myocarditis, hypotension, hypertension, arrhythmia, cardiogenic shock, stroke, myocardial infarction/STEMI, intracranial hemorrhage, thrombosis (deep vein thrombosis, cerebral venous thrombosis, arterial or venous thrombotic events, portal vein thrombosis, coronary thrombosis, microvascular small bowel thrombosis), and pulmonary embolism. METHODS: A systematic review of original studies reporting confirmed cardiovascular manifestations post-mRNA COVID-19 vaccination was performed. Following the PRISMA guidelines, electronic databases (PubMed, PMC NCBI, and Cochrane Library) were searched until January 2022. Baseline characteristics of patients and disease outcomes were extracted from relevant studies. RESULTS: A total of 81 articles analyzed confirmed cardiovascular complications post-COVID-19 mRNA vaccines in 17,636 individuals and reported 284 deaths with any mRNA vaccine. Of 17,636 cardiovascular events with any mRNA vaccine, 17,192 were observed with the BNT162b2 (Pfizer-BioNTech) vaccine, 444 events with mRNA-1273 (Moderna). Thrombosis was frequently reported with any mRNA vaccine (n = 13,936), followed by stroke (n = 758), myocarditis (n = 511), myocardial infarction (n = 377), pulmonary embolism (n = 301), and arrhythmia (n = 254). Stratifying the results by vaccine type showed that thrombosis (80.8%) was common in the BNT162b2 cohort, while stroke (39.9%) was common with mRNA-1273 for any dose. The time between the vaccination dosage and the first symptom onset averaged 5.6 and 4.8 days with the mRNA-1273 vaccine and BNT162b2, respectively. The mRNA-1273 cohort reported 56 deaths compared to the 228 with BNT162b2, while the rest were discharged or transferred to the ICU. CONCLUSION: Available literature includes more studies with the BNT162b2 vaccine than mRNA-1273. Future studies must report mortality and adverse cardiovascular events by vaccine types.

Transvenous Lead Extraction in Chronic Kidney Disease and Dialysis Patients With Infected Cardiac Devices.

BACKGROUND: Cardiac implantable electronic device infections have been on the rise. A high-risk population is that with renal disease, especially dialysis. We aimed to assess procedural profiles and clinical outcomes of transvenous lead extraction for cardiac implantable electronic device infection based on renal disease status. METHODS AND RESULTS: In 1420 consecutive patients undergoing transvenous lead extraction of infected cardiac implantable electronic devices (1996-2012), we assessed procedural profiles and clinical outcomes in 3 groups: normal renal function (group 1, n=1159), renal dysfunction not requiring dialysis (group 2, n=163), and dialysis (group 3, n=98). A total of 3182 infected leads were extracted. Dialysis patients had shorter lead dwell times and were less likely to require transvenous lead extraction tools but as likely to require femoral workstations. There were higher overall rates of procedure-related complications in dialysis patients (12% versus ≈6% in nondialysis) with no difference in the major complication rates (P=not significant). Complete procedural success rates were 94%, 96%, and 94% in groups 1, 2, and 3, respectively (P=not significant). There were 4 intraprocedural deaths in group 1 versus none in groups 2 and 3. Mortality rates were significantly higher in dialysis patients both at 1 and 6 months (P<0.0001 for both). In multivariable analyses, dialysis status was independently associated with increased mortality risk at 1 and 6 months. Other factors associated with mortality were lead material retention, functional (New York Heart Association) class, and occurrence of procedural complications. CONCLUSIONS: In patients with cardiac implantable electronic device infection, dialysis status did not seem to add complexity to transvenous lead extraction but was independently associated with increased mortality at 1 and 6 months.

Transvenous lead extraction at the time of cardiac implantable electronic device upgrade: Complexity, safety, and outcomes.

BACKGROUND: The practice of lead abandonment at the time of cardiac implantable electronic device upgrade remains a controversial topic but is affecting an increasing number of patients. Inherent risks include high-risk extractions of redundant leads when extraction is required at a later date. OBJECTIVES: We aimed to report our experience with transvenous lead extraction (TLE) at the time of device upgrade. METHODS: All consecutive TLE procedures at the time of device upgrade at the Cleveland Clinic between January 1, 1996 and December 31, 2012 were included (n = 503). Success and complications were defined according to the Heart Rhythm Society consensus document on TLE. RESULTS: There were a total of 984 leads in place, and 719 were targeted with extraction (589 pacer and 130 defibrillator leads, 63 of them being dual-coil leads). In all patients, TLEs aimed to avoid abandoning leads. Concomitant lead management issues included lead malfunction (15%), previously abandoned leads (9%), vascular access occlusion (6%), or leads on advisory (3%). In most procedures (75.4%), special extraction tools were needed. The complete procedural and clinical success rates were 96.6% and 97.2%, respectively. During planned extractions, damage of coexisting leads occurred in 19 patients (3.8%), eventually requiring extraction. The major and minor complication rates were 1% and 1.4%, respectively. CONCLUSION: In a high-volume center, TLEs at the time of device upgrade were successful in the vast majority of patients with a low complication rate.