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Transcatheter mitral valve repair (TMVR) with the MitraClip system is now approved for degenerative and functional mitral regurgitation (MR). Atrial fibrillation (AF) is commonly seen in MR. In our study, we perform a pooled analysis of the existing data to investigate the outcomes of MitraClip in patients with versus without AF. We conducted a systematic search of PubMed, Google Scholar, and SCOPUS databases through December, 2022 for studies comparing the outcomes of TMVR using the MitraClip in patients with preexisting AF versus those without AF. A meta-analysis was performed to investigate the primary outcomes of all-cause mortality and heart failure (HF) hospitalization. Secondary outcomes were cardiovascular mortality, in-hospital mortality, stroke, New York Heart Association class I or II at follow-up, length of hospital stay, and procedural time. A total of 10 studies (n = 24,111; AF = 12,789; no AF = 11,322) were included in the final analysis. Preexisting AF was associated with higher overall all-cause mortality (odds ratio 1.55, 95% confidence interval 1.32 to 1.83, p <0.0002) and higher overall HF hospitalization rate (odds ratio 1.3, 95% confidence interval 1.08 to 1.56, p <0.0154). There was no statistically significant difference in cardiovascular mortality, in-hospital mortality, stroke, length of hospital stay, procedural time, or New York Heart Association class I/II at follow-up comparing AF versus no AF. The presence of AF in patients who underwent TMVR with MitraClip is associated with higher all-cause mortality and HF hospitalization. This should be taken into consideration in the management of MR patients., Competing Interests: Declaration of competing interest The authors have no competing interests to declare., (Copyright © 2023. Published by Elsevier Inc.)

Background: Interns experience challenges in their transition from medical school to residency. Orientation is traditionally delivered by faculty and administrators and often does not address practical skills needed by interns during the transition., Objectives: The objective is to address traditional orientation gaps and improve incoming interns' transition experience.  Methods: We identified opportunities with our intern orientation using a quality improvement methodology. Plan Do Study Act (PDSA) cycle 1 consisted of a pilot boot camp. PDSA cycle 2 was conducted over two weeks, June 9-23, 2021, at the Detroit Medical Center, Detroit, MI. Participation was voluntary. Residents were assigned incoming interns on a 1:1 basis. Five virtual sessions were conducted addressing: daily workflow, documentation, presentation skills, and utilization of the Electronic Health Record (EHR). All participants received pre- and post-program surveys.  Results: Twenty-two rising second- and third-year residents (26%) and 22 incoming interns (58%) participated. There was a significant improvement in the understanding of daily workflow (mean improvement 0.957, p=0.003), and most tasks associated with EHR including comfort with the sign-out process (mean improvement 1.21; p=0.002), accessing specific team lists (mean improvement 1.75, p=0.001), writing orders (mean improvement 1.41; p=0.002), composing documentation (mean improvement 1.23; p=0.001). Writing notes improved significantly (mean improved by 0.52; p=0.04). Nearly all (93.2%) stated the program achieved its overall goals and believed (92.9%) the program should be continued for incoming intern classes., Conclusion: A targeted orientation bootcamp led by near-peers positively impacted the intern experience improving understanding of day-to-day responsibilities and comfort utilizing the electronic health record., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2024, Alhusain et al.)

Background Aspiration thrombectomy devices, such as the AngioVac, allow the removal of thrombus, especially in patients with contraindications to anticoagulation use. The AngioVac was approved by the U.S. Food and Drug Administration to remove fresh, soft thrombi or emboli during extracorporeal bypass for up to six hours. Real-world data on the most common modes of failure and complications associated with the AngioVac are unavailable. Methods The Manufacturer and User Facility Device Experience database was queried for reports of the AngioVac device failure and adverse events from April 2013 to March 2022. Categorical variables were described as numbers, and all statistical calculations were performed with IBM SPSS Statistics, version 27.0 (IBM Corp., Armonk, NY). Results A total of 115 events were reported during the study period. After the exclusion of duplicate reports, the final cohort included 93 reports. The most common mode of failure for the AngioVac was physical damage of the device, with 13 reports (14%). The most common vessels associated with events were the superior vena cava and inferior vena cava, occurring in 23 reports (24.7%). The most common adverse clinical events were pulmonary embolism (PE), occurring in 33 reports (35.5%), and perforation, occurring in 16 reports (17.2%). Other less frequent adverse outcomes were arrhythmias, stroke, and foreign body device embedment. There were 45 deaths reported with the use of the AngioVac. Conclusions Aspiration thrombectomy devices provide promising efficacy; however, physicians should be aware of known adverse outcomes, even if they are infrequent. Based on this analysis, PE and vessel perforation were the most common adverse outcomes. Furthermore, the most common mode of failure was secondary to physical damage of the device., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Dandu et al.)

Background and objective Aspiration thrombectomy devices, such as the AngioJet Solent Omni (Boston Scientific Corporation, Marlborough, MA) have been approved by the US FDA for the treatment of thrombi in peripheral arterial disease, venous disease, and AV fistulas. However, there is a dearth of real-world data on the most common modes of failure and complications associated with the AngioJet Solent Omni. In this study, we aimed to address this scarcity of data. Methods The MAUDE (Manufacturer and User Facility Device Experience) database was queried for reports of device failure and adverse events spanning the period from October 2012 to December 2021. Results A total of 499 events were reported during the study period. After the exclusion of duplicate reports, the final analysis included 450 reports. The most common mode of failure was catheter breakage/kinking during suction thrombectomy with 137 reports (30%). The most common vessel associated with events was the superficial femoral artery or vein, which was documented in 82 reports (18.2%). The most common adverse clinical outcome was the embedding of a piece of the device in the patient, which occurred in seven reports (1.6%). There were seven (1.6%) events of death reported during the period studied. Conclusions Based on our findings, theAngioJet Solent Omni device provides promising results; however, it is important to evaluate device safety. It is associated with complications including device embedment, catheter breakage/kinking, and death, and these adverse events are linked to patient characteristics and risk factors., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Dandu et al.)

Background: The Diamondback 360® Coronary Orbital Atherectomy System (Cardiovascular Systems Inc., St. Paul, MN) is the first and only orbital atherectomy system approved by the US FDA for the treatment of severely calcified lesions. While the device has proven to be safe in clinical trials, real-world data are minimal., Methods: The Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports on the Diamondback 360® Coronary from January 2019 to January 2022., Results: A total of 566 events were reported during the study period. After the exclusion of duplicate reports, the final cohort included 547 reports. The most common mode of failure was break or separation of a device part (40.4%, n = 221) mainly due to breaking in the tip of the ViperWire (66.1%), driveshaft (22.7%), or crown (12.2%). The most common vessel associated with events was the left anterior descending artery (31.4%), followed by the right coronary artery (26.9%), left circumflex (21.6%), and left main coronary artery (6.4%). The most common clinical adverse outcome was perforation (33.0%, n = 181) with 23.7% resulting in cardiac tamponade. Most perforation cases were treated by covered stent (44.2%), surgery (30.5%), stent (98%), and balloon angioplasty (9%). There were 89 (16.3%) events of death with 67% due to perforation (p < 0.001)., Conclusion: Our study provided a glimpse of real-world adverse outcomes and common modes of failure due to orbital atherectomy. The most common mode of failure was the break or separation of a device part and the most common complication was perforation according to the MAUDE database. It will help physicians to anticipate complications and escalate care appropriately., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Alhusain et al.)

Since its Food and Drug Administration approval in January 2007, the Angiosculpt scoring balloon catheter has been widely utilized in severely calcified stenotic vascular lesions. We sought to characterize the complication rates, failure modes, and outcomes associated with the Angiosculpt catheter. Using queried events from October 2013 to December 2020 from the Food and Drug Administration Manufacturer and User Facility Device Experience database, we analyzed the Angiosculpt scoring balloon catheter complication rates and mode of failure. A total of 248 complications were reported. Most reported complications occurred in the superficial femoral artery (SFA) (19.4%, n = 48), followed by the left anterior descending artery (8.1%, n = 20). Severe vessel calcifications were reported in (26.6%, n = 66) of the complications. Most complications occurred with damage to the device, such as tip break (44.8%, n = 111) and balloon rupture (26.6%, n = 66). Some complications were due to difficulties in the withdrawal of the catheter (23.8%, n = 59). Balloon rupture is observed at a significantly higher rate amongst calcified vessels (60.6% vs 14.8%), P = < 0.001, and in cases involving the SFA (39.4% vs 11.3%), P = < 0.001. All-cause complications in calcified vessels are associated with the SFA (39.4% vs 12.5%), P = < 0.001, and left anterior descending artery (16.7% vs 5.1%), P = < 0.001. The Angiosculpt scoring balloon catheter has a relatively low complication rate. Most complications were associated with a device tip break, balloon rupture, and difficulties in withdrawal in severely calcified vessels., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Introduction: Atrial fibrillation/flutter (AF) is common among patients with pulmonary hypertension (PH) and is associated with poor clinical outcomes. AF has been shown to occur more commonly among patients with postcapillary PH, although AF also occurs among patients with precapillary PH. The goal of this study was to evaluate the independent impact of PH hemodynamic phenotype on incident AF among patients with PH., Methods: We retrospectively identified 262 consecutive patients, without a prior diagnosis of atrial arrhythmias, seen at the PH clinic at Mayo Clinic, Florida, between 1997 and 2017, who had right heart catheterization and echocardiography performed, with follow-up for outcomes through 2021. Kaplan-Meier analysis and Cox-proportional hazards regression modeling were used to evaluate the independent effect of PH hemodynamic phenotype on incident AF., Results: Our study population was classified into two broad PH hemodynamic groups: precapillary (64.9%) and postcapillary (35.1%). The median age was 59.5 years (Q1: 48.4, Q3: 68.4), and 72% were female. In crude models, postcapillary PH was significantly associated with incident AF (HR 2.17, 95% CI: 1.26-3.74, p = 0.005). This association was lost following multivariable adjustment, whereas left atrial volume index remained independently associated with incident AF (aHR 1.30, 95% CI: 1.09-1.54, p = 0.003)., Conclusion: We found PH hemodynamic phenotype was not significantly associated with incident AF in our patient sample; however, echocardiographic evidence of left atrial remodeling appeared to have a greater impact on AF development. Larger studies are needed to validate these findings and identify potential modifiable risk factors for AF in this population., (© 2023 S. Karger AG, Basel.)

Background: We aim to conduct a comprehensive meta-analysis encompassing all studies to assess the efficacy of Vascepa in patients with diabetes mellitus (DM) in preventing or treating existing coronary artery disease (CAD)., Methods: Digital databases were queried. Odds ratios (OR) were calculated for the following outcomes: composite outcome, all-cause mortality, and cardiovascular mortality., Results: A total of 4 randomized control trials (33,092 patients; Vascepa n = 16586; Placebo n = 16506) were included in our analysis. The overall mean age was 64.3 years old (Vascepa = 64.3 years; Placebo = 64.3 years). The sample was 61.5% male (Vascepa = 60.8%; Placebo = 62.1%). In patients with DM, Vascepa was found to have no significant effect on the primary composite outcome (OR 0.97, 95%CI 0.91-1.04, p > 0.05), all-cause mortality (OR 0.96, 95%CI 0.90-1.03, p > 0.05), and cardiovascular mortality (OR 0.90, 95%CI 0.74-1.10, p > 0.05). Subgroup analysis by Vascepa type and treatment type was similarly non-significant., Conclusion: Our study concluded that Vascepa did not affect cardiovascular outcomes in patients with DM., Competing Interests: None declared by any authors involved in the manuscript., (© 2022 The Authors. Published by Elsevier Ltd on behalf of IJS Publishing Group Ltd.)

Background: The Turnpike catheters (Teleflex, Wayne, PA, USA) is a microcatheter that was approved by the Food and Drug Administration in November 2014 to be used to access discrete regions of the coronary and peripheral vasculature., Methods: The Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of the Turnpike catheters from March 2015 through August 2021., Results: A total of 216 reports were found during the study period. After excluding duplicate reports (n = 21), our final cohort included 195 reports. The most common failure mode was catheter tip break or detachment (83%, n  = 165) which was significantly associated with over-torquing (p-value = 0.025). The most common clinical consequence was the entrapment of the catheter (33%, n  = 65), followed by vessel injury (7.8% n = 15) and vessel occlusion (3.6%, n = 7). Most patients had no consequences (47.0%, n = 93) or recovered (11%, n = 22). A total of 4 deaths were reported. 35.8% of reports (n = 69) specified the presence of severe calcification in the target vessel. Over torquing by interventionists was reported in 33.2% of events (n = 64)., Conclusion: Despite clinical trials demonstrating the safety of the Turnpike catheters, complications can still occur. These data serve to inform operators about potentional risks and complications associated with the use of the device. Physicians should avoid over-torqueing which seems to be the most common mechanism for device complications., Competing Interests: None of the authors have any conflict of interest., (© 2022 The Authors.)

Failed user authentication is a common event. Forgotten passwords and fingerprint non-recognition are the most common causes. Therefore, there is a need for efficient backup authentication methods, known as fallback authentication. However, fallback authentication methods suffer from different security and usability issues. This study aims to improve the security and usability of knowledge-based fallback authentication in the form of static security questions. The approach proposed in this study was designed considering different factors, such as question features, authentication mechanisms, and the use of tools to aid in composing memorable and secure answers. This study used a two-part experiment with 23 participants to evaluate the proposed approach based on security model testing. The results show that the proposed approach offered improved resistance to blind guess, focused guess, and observation guess attacks. While usability was clearly improved with questions that were based on recognition mechanisms, our results indicate that fallback authentication systems need a flexible level of security and avoidance of complexity in composing answers. In addition, our results indicate the effectiveness of using user behavioral details in the choice of topics for questions, where behavioral questions must have both high recall levels and resistance against guessing attacks. This work theoretically extends the knowledge of fallback authentication research by evaluating new security questions for fallback authentication considering replace of classical topics of security questions by introducing new topics of security questions based on user behavior and personal preferences. Also, this study applies methods of managing answers to security questions by encouraging users to compose answers based on free strict rules that inspire them to create strong and memorable answers based on their own rules. In addition, the findings of this study could support the deployment of knowledge-based authentication in fallback systems as a practical contribution to the user authentication field., Competing Interests: The authors declare there are no competing interests., (©2022 AlHusain and Alkhalifah.)

As more patients recover from COVID-19 infection, long-term complications are beginning to arise. Our case report will explore a debilitating long-term complication, Post-COVID Interstitial Lung Disease (PC-ILD). We will introduce a patient who developed PC-ILD in the setting of diffuse large B-cell lymphoma, outlining a difficult hospital course, including a positive COVID-19 polymerase chain reaction (PCR) for more than 3 months. We will then discuss the human body's physiological response to the virus and how our patient was not able to adequately mount an immune response. Finally, the pathophysiology of PC-ILD will be explored and correlated with the patient's subsequent computed tomographic images obtained over a 3-month period. The difficult hospital course and complex medical decision-making outlined in this case report serve as a reminder for health care providers to maintain vigilance in protecting our most vulnerable patient population from such a devastating disease process.

Takotsubo cardiomyopathy (TC) is a syndrome characterized by acute and transient regional systolic myocardial dysfunction. TC often mimics myocardial infarction without obstructive coronary disease. We present a case of a 48-year-old woman who developed TC following the onset of polymorphic ventricular tachycardia in the setting of methadone intoxication.

There has been an accumulating evidence of association between COVID-19 (coronavirus disease 2019) infection and cardiovascular complications. We describe a case of a 58-year-old lady with a history of systolic heart failure and COVID-19 infection, who developed persistent symptomatic bradycardia, requiring pacemaker placement as unusual conductive tissue involvement of this novel coronavirus.

Esophago-pericardial fistulae is a rare and dreaded entity. Most reported cases in the literature were described in association with advanced upper gastrointestinal malignancies, prior surgical procedures, and radiofrequency atrial fibrillation ablation. It has been rarely reported in association with benign esophageal conditions. Surgery had been the mainstay of treatment, but there are increasingly reported cases treated successfully with esophageal stenting and pericardial drainage. In this article, we report a novel case of an esophago-pericardial fistulae occurring as a sequela of esophageal stent placed for the management of Boerhaave syndrome.

Introduction: Takotsubo Syndrome (TS) patients are at high risk of developing atrial fibrillation. We sought to investigate the outcomes and economic impact of atrial fibrillation on TS patients utilizing the National Inpatient Sample., Methods: Patients with TS were identified in the National Inpatient Sample (NIS) database between 2010 and 2014 using the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM), and subsequently were divided into two groups, those with and without atrial fibrillation. The primary outcome was all-cause in-hospital mortality in the two groups. Secondary outcomes were in-hospital complications. We also evaluated the length of hospital stay and the cost of hospitalization. Propensity score-matched analysis was performed to address potential confounding factors., Results: Among the study population, the prevalence of atrial fibrillation was 17.57%. After matching, the atrial fibrillation group had no significant increase of in-hospital mortality (OR: 1.13; 95% CI: 0.94-1.35, p = 0.211). However, atrial fibrillation patients were more likely to develop cardiac arrest and ventricular arrhythmias (OR: 1.51, 95% CI: 1.26-1.80, p < 0.0001), have higher rate of major cardiac complications when combined as a single endpoint in-hospital complication (OR: 1.16, 95% CI: 1.04-1.29, p: 0.006), also they were more likely to stay longer in hospital (OR: 1.13, 95% CI: 1.08-1.19, p < 0.0001), and have increased cost of hospitalization (OR: 1.13, 95% CI 1.07-1.20, p < 0.0001)., Conclusion: Atrial fibrillation does not increase in-hospital mortality in patients presenting with TS. However atrial fibrillation is associated with an increased risk of ventricular arrhythmias, length of stay, non-routine discharges and cost of hospitalization., Competing Interests: Declaration of Competing Interest None of the authors have any conflicts of interest to declare., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Comparative outcomes of transcatheter aortic valve implantation (TAVI) in patients with and without liver cirrhosis are scarce. This study aimed to assess the clinical outcomes and impact of liver cirrhosis on patients who underwent TAVI. Patient with liver cirrhosis who underwent TAVI 2011 to 2014 were identified in the National Inpatient Sample database using the International Classification of Diseases, ninth revision, Clinical Modification (ICD-9-CM). The primary outcome was the effect of liver cirrhosis on inpatient mortality. Secondary outcomes were the impact of liver cirrhosis on post-TAVI complications. We also evaluated the length of hospital stay and the cost of hospitalization. Propensity score-matched analysis was performed to address potential confounding. The cirrhotic patients who underwent TAVI had no significant increase in the risk of in-hospital mortality (odds ratio [OR] 1.12, 95% confidence interval [CI] 0.59 to 2.10, p = 0.734) or after procedural complications. Furthermore, cirrhotic patients were less likely to develop vascular complications requiring surgery (OR 0.47, 95% CI 0.23 to 0.98, p = 0.043), to develop after procedural deep vein thrombosis(OR <0.00, 95% CI <0.001 to <0.0001, p <0.0001), and to require pacemaker implantation. However, cirrhotic patients were more likely to undergo nonroutine hospital discharges (OR 1.50, 95% CI 1.15 to 1.96, p = 0.003). In conclusion, TAVI is a safe and reasonable therapeutic option for cirrhotic patients with severe aortic stenosis, requiring aortic valve replacement., (Copyright © 2018 Elsevier Inc. All rights reserved.)