Outcomes of Transcatheter Mitral Valve Repair Using the MitraClip System in Patients With Atrial Fibrillation. A Meta-Analysis.

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.

Transcatheter Aortic Valve Replacement in Bicuspid Versus Tricuspid Aortic Valve Stenosis: Meta-Analysis and Systemic Review.

Because of its anatomic and procedural complexities, bicuspid aortic valve (BAV) has been excluded from previous trials investigating transcatheter aortic valve replacement (TAVR). We aimed to compare the clinical outcomes of TAVR in BAV and tricuspid aortic valve patients. We searched the databases systematically from inception until March 2023 for studies that reported the outcomes of TAVR in BAV and tricuspid aortic valve patients. The primary focus was all-cause mortality at 1 year. Additional outcomes included outcomes at 30-day follow-up. Secondary and subgroup analyses were performed on propensity-matched patients, patients at low surgical risk, and based on the type of transcatheter valve type. We included 30 studies with a total of 193,274 patients who underwent TAVR, of which 14,353 patients had BAV stenosis. The rate of 1-year mortality was lower in the BAV group compared with the tricuspid group with the results reaching statistical significance (odds ratio [OR] 0.86, 95% confidence interval [CI] 0.75 to 0.98, p = 0.02). The rate of 30-day stroke, however, was higher in patients with BAV who underwent TAVR (OR 1.24, 95% CI 1.08 to 1.43, p <0.05). Other 30-day clinical outcomes were similar between the 2 groups. Similar outcomes were observed in secondary analysis of matched populations with less mortality and higher rate of stroke in patients with BAV (OR 0.84, 95% CI 0.72 to 0.96, p = 0.01, and OR 1.38, 95% CI 1.09 to 1.75, p <0.05, respectively). Comparing the outcomes for self-expandable and balloon-expandable valves resulted in similar results. Subgroup analysis of low-surgical-risk patients similarly showed lower 1-year mortality in patients with BAV (OR 0.67, 95% CI 0.50 to 0.91, p = 0.01), without difference in 30-day stroke between the 2 groups (OR 1.24, 95% CI 0.83 to 1.88, p = 0.30). In conclusion, this report indicates that TAVR is safe and feasible in patients with BAV, including patients at low surgical risk. The higher rate of 30-day stroke, however, warrants caution when pursuing TAVR in this population. More studies, specifically randomized trials, are still warranted to further assess the safety and the long-term outcomes in this group.

Outcomes of Orbital Atherectomy for the Treatment of Severely Calcified Coronary Artery Lesions.

Background Orbital atherectomy (OA) is used to prepare severely calcified coronary artery lesions before percutaneous coronary intervention (PCI). Intravascular ultrasound (IVUS) is used to determine the plaque volume and degree of stenosis within the arterial vessel. This study evaluated the safety and efficacy of OA for treating severely calcified coronary lesions and determined if IVUS impacted these outcomes. Methods We retrospectively collected data from a single center of patients with severe coronary artery calcification who underwent OA. The data on baseline characteristics and procedural and clinical outcomes were collected and analyzed. Results A total of 374 patients underwent OA. The mean age was 69 ± 12.7; 53.6% were Black, and 38% were female. Hypertension was present in 96% of the patients, followed by hyperlipidemia in 79.4%, diabetes mellitus in 53.7%, and chronic kidney disease (CKD) in 22.7%. More patients had presented with a non-ST-elevation myocardial infarction (NSTEMI) compared to ST-elevation myocardial infarction (STEMI) at 36.3% versus 4.3%, respectively. The radial artery was used in 35.4% of the cases, and the left anterior descending artery (LAD) was the most commonly treated vessel with OA at 61%, followed by the right coronary artery (RCA) at 30.7%. IVUS was utilized in 63.4% of cases. The most common complication of the procedure was perforation and dissection at an equal proportion of 1.3% among all patients. The no-reflow rate was 0.5%, and 0.5% developed post-procedural myocardial infarction (MI). The average length of stay was 4.7 days, while a marginal proportion, at 10.5%, had same-day discharge with no recorded complications. Conclusion In this analysis of patients with severely calcified coronary lesions, OA had low rates of major adverse cardiovascular events (MACE) and was considered a safe and effective treatment for complex coronary lesions.

Outcomes of Catheter-Based Pulmonary Artery Embolectomy in Patients With Sub-Massive to Massive Pulmonary Embolism.

Background Pulmonary embolism (PE) is the third leading cause of cardiovascular death after myocardial infarction and stroke. The ideal therapeutic approach for these patients remains undetermined. We report our single-center outcome data for using a catheter-based pulmonary artery thrombectomy using the FlowTriever (Inari Medical, Irvine, CA) device as management for patients with submassive PE. Methods We retrospectively collected data from a single center of patients who underwent thrombectomy using INARI FlowTriever device. The data on baseline characteristics, procedural and clinical outcomes was collected and analysed Results A total of 38 patients with PE treated endovascularly with the FlowTriever device were identified: 33 with submassive PE and five with massive PE. The mean age was 65.9 years (95% CI 61.9 - 69.8), and most patients were male (73.7%). All patients had right heart strain as the main indication for thrombectomy. Four patients (10.53%) required pressor support before the procedure. In 31 patients, pre- and post-thrombectomy average mean pulmonary artery pressure (mPAP) was improved significantly by 22% (p < 0.01). Two patients had significant adverse events at 48 hours (5.26%). One patient experienced procedure-related access site hematoma and life-threatening bleeding, while another developed intraprocedural-related massive hemoptysis and cardiopulmonary arrest. Overall post-procedural length of stay was 7.7 ± 5.6 days; 52.63% of patients (n = 20) required intensive care. Three patients (7.89%) required pressor support before the procedure, and 78.9% of patients (n = 30 of 38) survived hospital discharge. Thirty patients who survived were discharged with oral anticoagulation. There were no device-related complications. Conclusion Randomized trials of interventional devices for submassive PE are warranted to either support or alert the medical community of the safety and efficacy of their use for patients with submassive and massive PE. In time, pulmonary embolism response team (PERT) may generate outcome data that better inform treatment decisions.

Turnpike Catheter failure, causes and mechanisms: Insights from the MAUDE database.

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.

Plasminogen Activator Inhibitor-1 4G/5G Polymorphism Presenting as Recurrent Ischemic Stroke: The Microthrombi Shower.

Certain clinical scenarios should alert a physician to take a deeper look into causative pathological processes. This was evident in the case of a 41-year-old man who presented for recurrent micro thromboembolic strokes, which is atypical for the patient's age. Our desire to explain the pathological process led to the rare finding of a plasminogen activator inhibitor-1 polymorphism, which has been associated with an increased risk of cerebrovascular thrombosis. A defect in this pathway leads to the inhibition of the tissue plasminogen activator protein. This genetic polymorphism has relatively been unexplored in recent medical literature, and we are hoping that our case may inspire future research that could help potential targets of risk factor stratifications as well as the development of novel pharmacological options.

Lutetium-177 Dotatate-Induced Hemolytic Anemia and Myelodysplastic Syndrome.

Lutetium-177 (177Lu) dotatate is a type of peptide receptor radioligand therapy (PRRT) using radiolabeled somatostatin for patients with progressive somatostatin receptor-positive gastrointestinal neuroendocrine tumors. While cases of therapy-related myeloid neoplasms (t-MN) have been described as a consequence of 177 Lu dotatate, there are no reports of hemolytic anemia associated with therapy. We present a case of a 68-year-old woman with metastatic low-grade neuroendocrine tumor who presented four weeks after the second dose of 177Lu dotatate with progressive fatigue and dyspnea. Laboratory workup was remarkable for hemolytic anemia. Lutetium-177 dotatate-induced hemolysis was suspected after ruling out other causes. Corticosteroid treatment was initiated with improvement in hemoglobin, and dose-reduced PRRT was planned upon discharge. Six months into the treatment course of 177Lu dotatate, macrocytic anemia was noticed on routine follow-up with normal vitamin B12 and folic acid levels. A bone marrow biopsy was done, revealing myelodysplastic syndrome (MDS) features. Given the temporal relationship between drug introduction and the objective findings, early-onset 177Lu dotatate-induced MDS was diagnosed with a plan for close hematologic follow-up. Myelodysplastic syndrome should be suspected when megaloblastic anemia develops in patients with previous 177Lu dotatate therapy. The latency period between initial treatment and MDS diagnosis reported in the literature ranges between 15 months to seven years. Apart from the unusually early onset of MDS, what is unique about our case is the development of hemolytic anemia after administration of PRRT. The clinical course and the brisk response to steroid therapy, suggest other mechanisms of PRRT toxicity besides DNA breaks, genetic mutations, and myelosuppression by an immune-mediated component that likely plays a role in 177Lu dotatate toxicity. Further investigation and monitoring are needed to identify the frequency of such adverse events and the pathophysiology of their occurrence.

RETRACTED: Cardiovascular outcomes of ethyl eicosapentaenoic acid in diabetes mellitus: A meta-analysis.

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.

SARS-CoV-2 Viral Load and Myocardial Injury: Independent and Incremental Predictors of Adverse Outcome.

To evaluate the association of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) initial viral load (iVL) and the incidence of myocardial injury (MCI) in hospitalized patients with SARS-CoV-2 infection, we conducted a retrospective longitudinal study of hospitalized patients who had a nasopharyngeal swab sample on admission that returned a positive result for SARS-CoV-2 by polymerase chain reaction between April 4 and June 5, 2020. The cycle threshold (Ct) value was used as a surrogate for the iVL level, with a Ct level of 36 or less for elevated iVL and greater than 36 for low iVL. Myocardial injury was defined as an elevated high-sensitivity cardiac troponin I level that was higher than the 99th percentile upper reference limit. A total of 270 patients were included. Of these, 171 (63.3%) had an elevated iVL and 88 (32.6%) had MCI. There was no significant difference in the incidence of MCI in patients with low iVL compared to those with elevated iVL (28 of 99 [28.3%] vs 60 of 171 [35.1%]; P=.25). In a multivariable model, MCI (odds ratio, 3.86; 95% CI, 1.80 to 8.34; P<.001) and elevated iVL (odds ratio, 4.21; 95% CI, 2.06 to 8.61; P<.001) were independent and incremental predictors of in-hospital mortality. The SARS-CoV-2 iVL level is not associated with increased incidence of MCI, although both parameters are strong independent and incremental predictors of mortality. Understanding the MCI mechanisms allows for early focused interventions to improve survival, especially in patients with SARS-CoV-2 infection and high iVL.