From Mayo Clinic, Rochester, MN (A.D., P.A.N., S.K., A.N., S.M., Y.M.C., P.F., S. Asirvatham); University of Miami Miller School of Medicine, Miami, FL (N.P., J.O.C., J.F.V.-G.); Icahn School of Medicine at Mount Sinai, New York, NY (A.A.P., S. Arora); Yal
Citations 6
A Systematic Review of the Cardiovascular Manifestations and Outcomes in the Setting of Coronavirus-19 Disease
The impact of coronavirus disease, 2019 (COVID-19), has been profound. Though COVID-19 primarily affects the respiratory system, it has also been associated with a wide range of cardiovascular (CV) manifestations portending extremely poor prognosis. The principal hypothesis for CV involvement is through direct myocardial infection and systemic inflammation. We conducted a systematic review of the current literature to provide a foundation for understanding the CV manifestations and outcomes of COVID-19. PubMed and EMBASE databases were electronically searched from the inception of the databases through 27 April 2020. A second literature review was conducted to include major trials and guidelines that were published after the initial search but before submission. The inclusion criteria for studies to be eligible were case reports, case series, and observation studies reporting CV outcomes among patients with COVID-19 infection. This review of the current COVID-19 disease and CV outcomes literature revealed a myriad of CV manifestations with potential avenues for treatment and prevention. Future studies are required to understand on a more mechanistic level the effect of COVID-19 on the myocardium and thus provide avenues to improve mortality and morbidity.
Utilization and procedural adverse outcomes associated with Watchman device implantation
AbstractAims The Food and Drug Administration (FDA) approval of the Watchman device [percutaneous left atrial appendage occlusion (LAAO)] has resulted in the widespread use of this procedure in many centres across the USA. We sought to estimate the nationwide utilization and frequency of adverse outcomes associated with Watchman device implantation. The objective of this study was to evaluate the Watchman device implantation peri-procedural complications and comparison of the results with the previous studies.Methods and results The National Inpatient Sample (NIS) was queried for all hospitalizations with a primary diagnosis of atrial fibrillation or atrial flutter during the year 2016 with percutaneous LAAO during the same admission (ICD-10 code—02L73DK). The frequency of peri-procedural complications, including mortality, procedure-related stroke, major bleeding requiring blood transfusion, and pericardial effusion, was assessed. We compared the complication rates with the published randomized controlled trials and the European Watchman registry. An estimated 5175 LAAO procedures were performed in 2016. The majority of procedures was performed in males (59.1%), age ≥75 years (58.7%), and White (83.1%). The overall complication rate was 1.9%. The in-hospital mortality was 0.29%. Pericardial effusion requiring pericardiocentesis was the most frequent complication (0.68%). Bleeding requiring transfusion was noted in 0.1% of device implants. The rates of post-procedure stroke and systemic embolism were 0% and 0.29%, respectively.Conclusion Percutaneous LAAO with the Watchman device in the USA is associated with low in-hospital complications and a similar safety profile to a recently published EWOLUTION cohort. The complication rates were lower than those reported in the major randomized clinical trials (RCTs). We report the frequency of peri-procedural complications of the LAAO using the Watchman device from the NIS database. We also compare the frequency of peri-procedural complications with the previously published RCTs and EWOLUTION cohort. Our findings are in concordance with findings from EWOLUTION cohort and compare favourably with RCTs.
Level of block: atrioventricular node, infra-Hisian, or intramyocardial?—Authors’ reply
AbstractIntroductionThe outcomes of repeated cardiovascular implantable electronic device (CIED) lead extraction have not been well studied. We sought to determine the indications, outcomes, and safety of repeated lead extraction procedures.MethodsThis retrospective study was conducted using data from two medical centers, including 38 patients who had undergone two or more lead extraction procedures compared to 439 patients who had a single procedure. The electronic medical records and procedural databases were reviewed to determine the indications, procedural characteristics, and outcomes. The outcomes of the first procedure were compared to the outcomes of subsequent procedures.ResultsThe 5‐year cumulative probability of a repeated extraction procedure was 11% (95% confidence interval, 7%–15%). In 439 patients who underwent single lead extractions, 72% had device and lead related infections as the procedure indication compared to 39% for 38 patients who underwent repeated extraction (P < 0.001). The mean duration from device reimplant to repeated extraction procedures was 63 ± 48 months. Ninety‐eight percent of the leads were removed completely in repeated procedures, similar to the 95% success rate of the first procedure (P = 0.51). There was no significant difference in major complication rate in the first or repeated extractions (2.6% vs 5.2%, P = 0.79).ConclusionsRepeated transvenous lead extraction is not uncommon. It had a high success rate comparable to that of the initial procedure and was not associated with an increased incidence of adverse events.
Frequency of in‐hospital adverse outcomes and cost utilization associated with cardiac resynchronization therapy defibrillator implantation in the United States
AbstractBackground: The utilization of cardiac resynchronization therapy defibrillator (CRT‐D) has increased significantly, since its initial approval for use in selected patients with heart failure. Limited data exist as for current trends in implant‐related in‐hospital complications and cost utilization. The aim of our study was to examine in‐hospital complication rates associated with CRT‐D and their trends over the last decade.Methods and Results: Using the Nationwide Inpatient Sample, we estimated 378 248 CRT‐D procedures from 2003 to 2012. We investigated common complications, including mechanical, cardiovascular, pericardial complications (hemopericardium, cardiac tamponade, or pericardiocentesis), pneumothorax, stroke, vascular complications (consisting of hemorrhage/hematoma, incidents requiring surgical repair, and accidental arterial puncture), and in‐hospital deaths described with CRT‐D, defining them by the validated International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code. Mechanical complications (5.9%) were the commonest, followed by cardiovascular (3.6%), respiratory failure (2.4%), and pneumothorax (1.5%). Age (≥65 years), female gender (OR, 95% CI; P value) (1.08, 1.03‐1.13; 0.001), and the Charlson score ≥3 (1.52, 1.45‐1.60; <0.001) were significantly associated with increased mortality/complications.Conclusions: The overall complication rate in patients undergoing CRT‐D has been increasing in the last decade. Age (≥65), female sex, and the Charlson score ≥3 were associated with higher complications. In patients who underwent CRT‐D implantation, postoperative complications were associated with significant increases in cost.
Trends in Use and Adverse Outcomes Associated with Transvenous Lead Removal in the United States
Background— Transvenous lead removal (TLR) has made significant progress with respect to innovation, efficacy, and safety. However, limited data exist regarding trends in use and adverse outcomes outside the centers of considerable experience for TLR. The aim of our study was to examine use patterns, frequency of adverse events, and influence of hospital volume on complications. Methods and Results— Using the Nationwide Inpatient Sample, we identified 91 890 TLR procedures. We investigated common complications including pericardial complications (hemopericardium, cardiac tamponade, or pericardiocentesis), pneumothorax, stroke, vascular complications (consisting of hemorrhage/hematoma, incidents requiring surgical repair, and accidental arterial puncture), and in-hospital deaths described with TLR, defining them by the validated International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code. We specifically assessed in-hospital death (2.2%), hemorrhage requiring transfusion (2.6%), vascular complications (2.0%), pericardial complications (1.4%), open heart surgery (0.2%), and postoperative respiratory failure (2.4%). Independent predictors of complications were female sex and device infections. Hospital volume was not independently associated with higher complications. There was a significant rise in overall complication rates over the study period. Conclusions— The overall complication rate in patients undergoing TLR was higher than previously reported. Female sex and device infections are associated with higher complications. Hospital volume was not associated with higher complication rates. The number of adverse events in the literature likely underestimates the actual number of complications associated with TLR.