Investigating the Complications and Causes of Failure of the AngioVac System: A Post-Marketing Surveillance From the MAUDE Database.

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.

Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome: A Systematic Review and Meta-Analysis.

Limited data comparing prasugrel and ticagrelor in acute coronary syndrome are available. Online databases, including MEDLINE and Cochrane Central, were queried to compare these drugs. The primary outcomes of this meta-analysis are myocardial infarction (MI), all-cause mortality, cardiovascular mortality, noncardiovascular mortality, stent thrombosis, and stroke. The secondary outcome is major bleeding. A total of 9 studies, including 94,590 patients (prasugrel group = 32,759; ticagrelor group = 61,831), were included in this meta-analysis. The overall mean age was 62.73 years, whereas the mean age for the ticagrelor and prasugrel groups was 63.80 and 61.65 years, respectively. Prasugrel is equally effective as compared with ticagrelor in preventing MI. There was no difference between the 2 groups regarding all-cause mortality, stent thrombosis, stroke, or major bleeding. In patients with acute coronary syndrome, prasugrel is equally effective when compared with ticagrelor in preventing MI.

Outcomes of Transcatheter Aortic Valve Replacement With and Without Index Chronic Total Occlusion of Coronary Artery: A Propensity Matched Analysis.

Transcatheter aortic valve replacement (TAVR) utilization is increasing, along with procedural success. Coronary angiography is frequently performed before the TAVR procedure for coronary artery disease workup. Chronic total occlusion (CTO) of the coronary artery shares common risk factors with aortic stenosis and could be challenging, especially in terms of procedural safety. The outcomes of TAVR among patients with concomitant CTO are not extensively studied. We analyzed the National Inpatient Sample database between October 2015 and December 2020 to evaluate the clinical characteristics, procedural safety, and outcomes among patients who underwent TAVR who had concomitant CTO lesions. A total of 304,330 TAVRs were performed between 2015 and 2020, 5,235 of which (1.72%) were in patients with TAVR-CTO and 299,095 (98.28%) in those with TAVR-no CTO. After propensity matching, there was no difference in the odds of in-hospital mortality (adjusted odds ratio [aOR] 1.28, 95% confidence interval [CI] 0.94 to 1.75, p = 0.11). However, TAVR-CTO was associated with an increased incidence of acute myocardial infarction (aOR 1.27, 95% CI 1.05 to 1.53, p = 0.01), cardiac arrest (aOR, 2.60, 95% CI 1.64 to 4.11, p <0.0001), and need for mechanical circulatory support (aOR 2.6, 95% CI 1.88 to 3.59, p <0.0001). There was no difference in the incidence of stroke, major bleeding, complete heart block, or requirement for permanent pacemaker between the 2 groups. However, the TAVR-CTO cohort had a slightly greater length of stay and total hospitalization cost. TAVR is a relatively safe procedure among those with concomitant CTO lesions; however, it is associated with a greater incidence of acute myocardial infarction, cardiac arrest, and requirement for mechanical circulatory support.

Coronary Intra-orbital Atherectomy Complications and Procedural Failure: Insight From the Manufacturer and User Facility Device Experience (MAUDE) Database.

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.

Predictors and Outcomes of Extracorporeal Membrane Oxygenation in COVID-19 Patients With ARDS: A Propensity-Matched Analysis of National Inpatient Sample.

Extracorporeal membrane oxygenation (ECMO) is a significant treatment modality for COVID-19 patients on ventilators. The current data is limited for understanding the indicators and outcomes of ECMO in COVID-19 patients with acute respiratory distress syndrome (ARDS). The National Inpatient Sample (NIS) database from 2020 was queried in this study. Among 1,666,960 patients admitted with COVID-19, 99,785 (5.98%) patients developed ARDS, and 60,114 (60.2%) were placed on mechanical ventilation. Of these mechanically ventilated COVID-ARDS patients, 2580 (4.3%) were placed on ECMO. Patients with ECMO intervention had higher adjusted odds (aOR) of blood loss anemia (aOR 9.1, 95% CI: 6.16-13.5, propensity score-matched (PSM) 42% vs 5.4%, P < 0.001), major bleeding (aOR 3.79, 95% CI: 2.5-5.6, PSM 19.9% vs 5.9%, P < 0.001) and acute liver injury (aOR 1.7, 95% CI: 1.14-2.6 PSM 14% vs 6%, P = 0.009) compared to patients without ECMO intervention. However, in-hospital mortality, acute kidney injury, transfusions, acute MI, and cardiac arrest were insignificant. On subgroup analysis, patients placed on veno-arterial ECMO had higher odds of cardiogenic shock (aOR 13.4, CI 3.95-46, P < 0.0001), cardiac arrest (aOR 3.5, CI 1.45-8.47, P = 0.0057), acute congestive heart failure (aOR 4.18, CI 1.05-16.5, P = 0.042) and lower odds of major bleeding (aOR 0.26, CI 0.07-0.92). However, there was no significant difference in mortality, intracranial hemorrhage, and acute MI. Further studies are needed before considering COVID-19 ARDS patients for placement on ECMO.

Aortic Root Abscess Presenting As Chest Pain and Ischemic EKG Changes: Importance of Timely Diagnosis.

The occurrence of perivalvular abscess, a purulent infection that affects the myocardium and endocardium of natural or artificial valve tissues, can result from either the spread of bacteria from a distant source via bacteremia, or from the expansion of an existing infectious cardiac focus, such as infective endocarditis (IE). The aortic abscess should be suspected in patients with infective endocarditis who fail to improve despite being on appropriate antibiotics. Sometimes aortic abscesses can present as PR interval lengthening or heart block due to the extension of infection. We present an atypical presentation of aortic root abscess with chest pain and ischemic EKG changes. A 45-year-old intravenous drug user presented with chest pain episodes with EKG showing ST depression in V2-V6 and ST elevation in avR. The coronary angiographic study showed no significant coronary artery disease, but the patient complained of chest pain. Transthoracic echo in the catheterization lab showed severe aortic regurgitation. The patient became hemodynamically unstable, worsened his respiratory status, and had to be intubated. He had a bedside transesophageal echo that revealed an aortic root abscess. The patient's condition continued deteriorating, and he passed away the same day. This case focuses on the timely diagnosis of aortic root abscess, and Transesophageal echocardiography (TEE) is the gold standard for diagnosing aortic root abscesses. This case also focuses on keeping perivalvular abscess among our differentials in a patient presenting with chest pain and abnormal EKG, especially in a high-risk population.

Desensitization therapy using 'Mariana Castells' protocol in a patient with multiple autoimmune disorders- does it work?

Clinical use of antibiotics is becoming more widespread with each passing day for various infectious diseases. This has caused an abrupt increase in hypersensitivity reactions linked to these drugs, sometimes preventing the use of first-line therapies. In these patients, clinical presentation may vary from mild skin infections to life-threatening anaphylactic reactions. Our patient is a 30 year old female with past medical history significant for mast cell activation syndrome and multiple autoimmune diseases who presented with chief complaint of fever. Patient was diagnosed with MSSA bacteremia requiring the start of an antibiotic regimen. Mariana castells protocol was used for desensitizing the patient before starting her on antibiotic regimen. Patient was desensitized in 2 days using the standard 12-step protocol and started on cefazolin for her long-term treatment of the infection. No acute episodes of drug hypersensitivity were reported. During the course of her hospital admission, she improved significantly with no complications. Our patient having a history of both multiple autoimmune diseases and mast-cell activation syndrome tolerated the protocol well with no complications. Appropriate treatment of the reactions including epinephrine use and management with personalized desensitization protocols can enhance the quality of life, life expectancy, and safety of an increasing at risk population of patients with infectious diseases allergic to their best medications. Protocols, such as mariana castells, are completely safe in autoimmune disorders and should be utilized as the standard of care in appropriate patient population.

Idiopathic thyroid storm mimicking SIRS in a patient with hypothyroidism- a diagnostic dilemma.

Thyroid storm, defined as an endocrine emergency in 1926, remains a challenge for physicians in the 21st century. The mortality rate of untreated thyroid storm is very high. Hence, if a thyroid storm is suspected, treatment should not be delayed. This disease can be fatal! We present the case of a 86-year-old female presenting with altered mental status. All the tests came out negative except for elevated free t4 (ft4) with a very low TSH level (ft4-7.87, TSH< 0.005). Patient was diagnosed with thyroid storm in the setting of subclinical hypothyroidism and improved significantly with treatment. Furthermore, it is essential to confirm the TSH level in a patient with subclinical hypothyroidism. By carefully finding the extent of the disease, one can easily distinguish between hypo-or hyper- thyroid disease. The clinical features of thyroid storm may be related to other co-morbidities which makes diagnosis a clinical challenge. Nonetheless, it is important to be aware of the possibility of development of a thyroid storm in patients with a history of subclinical hypothyroidism. In addition, patients, if diagnosed with a thyroid storm, should be treated immediately with appropriate medications since thyrotoxicosis is life threatening.

EuroSCORE vs. EuroSCORE II vs. Society of Thoracic Surgeons risk algorithm.

INTRODUCTION: This study presents a validation series for EuroSCORE II compared with the previous additive and logistic EuroSCORE and the Society of Thoracic Surgeons risk prediction algorithm. PATIENTS AND METHODS: Clinical data of 2004 patients undergoing isolated coronary artery bypass surgery between 2006 and 2010 were retrospectively collected and individual expected risks of death were calculated by all 3 risk prediction algorithms. Performance of these risk algorithms was evaluated in terms of discrimination and calibration. RESULTS: There were 76 deaths (3.8%) among 2004 patients. The mean EuroSCORE II predicted mortality was 3.72% ± 5.11%, additive EuroSCORE was 4.35% ± 3.65% and logistic EuroSCORE was 6.41% ± 10.06%. The additive EuroSCORE was better than EuroSCORE II in terms of both discrimination and calibration (C-statistic 0.866 and Hosmer-Lemeshow p value 0.230 vs. C-statistic 0.836 and Hosmer-Lemeshow p value 0.013 for EuroSCORE II). In a subset of 380 patients, we compared EuroSCORE II with the Society of Thoracic Surgeons risk prediction. Actual mortality was 2.89%. Predicted mortality by EuroSCORE II was 4.27% ± 5.22% and Society of Thoracic Surgeons risk prediction was 2.30% ± 4.16%. The area under the curve was 0.759 for EuroSCORE II and 0.898 for the Society of Thoracic Surgeons risk prediction, whereas the Hosmer-Lemeshow p value was 0.267 for EuroSCORE II and 0.981 for Society of Thoracic Surgeons risk prediction. CONCLUSION: The Society of Thoracic Surgeons risk prediction algorithm is a better risk assessment tool compared to additive and logistic EuroSCORE and EuroSCORE II in Pakistani patients.