Safety and efficacy of apixaban, dabigatran and rivaroxaban in obese and morbidly obese patients with heart failure and atrial fibrillation: A real-world analysis.

BACKGROUND: Atrial fibrillation and heart failure are combined risk factors for thromboembolic events. Obese and morbidly obese individuals have been underrepresented in clinical trials studying safety and efficacy of direct oral anticoagulants (DOACs). OBJECTIVES: Study the comparative safety and efficacy of DOACs in obese and morbidly obese patients with atrial fibrillation or flutter, and concomitant congestive heart failure. METHODS: In the present single-center retrospective observational study, patients with an ICD-9 code of atrial fibrillation or atrial flutter, and congestive heart failure on a DOAC (apixaban[n = 155], rivaroxaban[n = 335], dabigatran[n = 393]) were followed for a median 12.5 months (IQR: 22.1 months). Obesity was defined as a body mass index, BMI ≥ 30 and < 40 kg/m2 [n = 614], and morbid obesity as BMI ≥ 40 kg/m2 [n = 269]. Clinical endpoints were grouped into safety (composite of intracranial-hemorrhage, gastrointestinal-bleeds, hemorrhagic-stroke, and other bleeds), and efficacy (composite of ischemic-stroke and systemic-embolism) endpoints. Cox proportional hazard models were used to compare safety, efficacy, and all-cause mortality outcomes. RESULTS: In obese patients, no statistical difference was observed in efficacy of DOACs. A statistical difference was observed in the safety of DOACs in obese patients. Apixaban was found to be safer than dabigatran [hazard ratio [HR] 0.37 (0.16-0.87), p = .02] and rivaroxaban [HR 0.29 (0.12-0.67), p = .004]. In morbidly obese patients, there was no overall statistical difference in the efficacy or safety of DOACs. CONCLUSION: In obese patients with congestive heart failure and atrial fibrillation or atrial flutter on DOACs, apixaban has the most favorable safety profile compared to rivaroxaban and dabigatran.

Sex Differences in Periprocedural and Long-Term Outcomes Following Transcatheter Left Atrial Appendage Occlusion: A Systematic Review and Meta-Analysis.

BACKGROUND: Atrial fibrillation (AF) is among the most common arrhythmias associated with an increased risk of cardioembolic phenomena, including stroke. Percutaneous left atrial appendage occlusion (LAAO) has proven beneficial in reducing stroke and mortality in patients with atrial fibrillation who have contraindications to anticoagulation. However, the sex differences in outcomes following LAAO have not been studied systematically. METHODS: Electronic databases PUBMED, Embase, and Web of Science were systematically searched until March 2022 for studies evaluating patient outcomes following LAAO for AF. The primary outcomes of interest were the risks of periprocedural stroke, major bleeding, pericardial complications, and all-cause mortality. Secondary outcomes included stroke risks, major bleeding, device-related thrombus, cardiovascular and all-cause mortality on long-term follow-up. A random-effects model meta-analysis was conducted, and heterogeneity was assessed using the I-squared test. RESULTS: Sixteen studies were included in the final analysis encompassing 111,775 patients, out of which 45,441 (40.7 %) were women. Women had a significantly higher risk of peri-procedural complications including all-cause mortality [relative risk (RR), 95 % confidence intervals (CI); RR 1.94, 95 % CI 1.40-2.69], stroke [RR 1.85, 95 % CI 1.29-2.67], major bleeding [RR 1.63, 95 % CI 1.08-2.44], and pericardial events [RR 1.80, 95 % CI 1.58-2.05]. However, there were no statistically significant differences between sexes in terms of risk of stroke, major bleeding, device-related thrombus, cardiovascular and all-cause mortality on long-term follow-up. CONCLUSION: Among patients undergoing LAAO implantation, women were at higher risk of periprocedural complications than men. This risk was not significant on long-term follow-up.

Leigh's disease, a fatal finding in the common world: A case report.

Leigh syndrome is a neurodegenerative mitochondrial disorder of childhood characterized by symmetrical spongiform lesions in the brain. The clinical presentation of Leigh's syndrome can vary significantly. However, in the majority of cases, it usually presents as a progressive neurological disease involving motor and cognitive development. It is common to see signs and symptoms of the midbrain and brainstem involvement. Limited data are present on the brain processes occurring in Leigh's syndrome which can be attributed to fatal respiratory failure. Raised lactate levels in the blood and/or cerebrospinal fluid are noted. Magnetic resonance imaging (MRI) findings such as necrotic, symmetrical lesions in the BG/brain stem are helpful in arriving at the diagnosis of Leigh's syndrome. It's of utmost importance to determine whether fatal respiratory failure can be predicted based on clinical characteristics and findings on MRI. In our report, we presented 3 cases from rural India, including a 2-year-old male child presenting with UMN lesion signs, a 3-month-old female infant with delayed developmental milestones with lab results suggestive of Leigh's disease, and a 12-year-old female child with epistaxis and generalized weakness. As discussed above, all 3 cases presented differently with a variety of signs and symptoms and would have gone undiagnosed without the use of brain imaging. The study concluded with the impression that while MRI is essential to the initial diagnosis of Leigh's disease, MRI alone cannot be used to predict fatal respiratory failure in patients with Leigh's disease. In any dilemma regarding diagnosis even with MRI, molecular studies remain the gold standard.

Outcomes of Intravascular Ultrasound-Guided Versus Angiography-Guided Percutaneous Coronary Interventions in Chronic Total Occlusions: A Systematic Review and Meta-Analysis.

BACKGROUND: Percutaneous coronary interventions (PCI) with intravascular ultrasound (IVUS) guidance have been associated with better long-term outcomes, but adoption remains limited. There are limited data on the impact of IVUS on chronic total occlusion (CTO)-PCI. OBJECTIVES: To examine the impact of IVUS guidance on the outcomes of CTO-PCI. METHODS: We performed a systematic review and study-level meta-analysis of IVUS vs angiography-guided CTO-PCI. Electronic databases were systematically searched for all pertinent studies from inception through January 2021. Randomized controlled trials (RCT), registry data, and abstracts published in peer-reviewed indexed journals were included. We examined the following in-hospital and long-term outcomes: major adverse cardiac events; all-cause mortality; cardiovascular mortality; myocardial infarction (MI); target-vessel revascularization (TVR); target-lesion revascularization (TLR); and stent thrombosis (ST). We also evaluated the following procedural metrics: procedure time; fluoroscopy time; contrast volume; total stent length; and total number of stents. Random-effects models were used to pool individual study results. RESULTS: Four (2 observational, 2 randomized) studies including 1975 patients (IVUS-guided PCI, 861 patients; angiography-guided PCI, 1114 patients) were included in the analysis. IVUS-guided CTO-PCI had similar all-cause mortality, major adverse cardiac events, cardiovascular mortality, MI, TVR, and TLR compared with angiography-guided CTO-PCI, but lower risk of stent thrombosis (odds ratio, 0.24; 95% confidence interval, 0.08-0.76; P=.02; I²=0%), shorter procedure time (P<.001; I²=88%), shorter fluoroscopy time (P<.001; I²=63%), and less contrast volume use (P<.001; I²=59%). Total stent length (P<.001; I²=39%) and total number of stents (P<.001; I²=72%) were lower with IVUS-guided CTO-PCI. CONCLUSION: IVUS-guided CTO-PCI is associated with lower risk of ST.

The Perils of Buddy Wire Use With a Filterwire.

Embolic protection devices may decrease the risk of distal embolization during percutaneous coronary intervention of saphenous vein graft and highly thrombotic lesions. Use of a buddy wire can facilitate equipment delivery but carries perils when used together with a filter. We present two cases demonstrating potential complications of buddy wire use with a filter. In the first case a saphenous vein graft perforation occurred after stenting. A buddy wire and second balloon were used to maintain hemostasis while removing the Filterwire. The buddy wire, however, was caught in the filter retrieval catheter, interlocking the two guide catheters and was eventually removed after forceful pulling. In the second case a Filterwire was used to prevent distal embolization of a highly thrombotic right coronary artery lesion. A buddy wire was used to assist with equipment delivery. A stent was inadvertedly deployed over the buddy wire, entrapping the Filterwire. The entrapped Filterwire was eventually removed after multiple balloon inflations over the buddy wire.

Complications and Failure Modes of Covered Coronary Stents: Insights From the MAUDE Database.

BACKGROUND: Data on the mechanisms of failure of covered coronary stents [Graftmaster, PK Papyrus] are limited. METHODS: We queried the "Manufacturer and User Facility Device Experience" (MAUDE) database between August 2018 (when the PK Papyrus stent was FDA approved) and December 2020 for reports on covered coronary stents. RESULTS: We identified 299 reports in the MAUDE database (after excluding duplicates, peripheral vascular reports, and incomplete records) (Graftmaster n = 225, PK Papyrus n = 74). The most common mechanism of failure of covered stents was failure to deliver the stent (46.2%), followed by stent dislodgement (22.4%) and failure to seal the perforation (19.7%). Failure to deliver the stent was more often reported with Graftmaster compared with PK Papyrus (59.1% vs. 6.8%, p < 0.001). Stent dislodgement was more often reported with PK Papyrus compared with Graftmaster (75.7% vs. 4.9%, p < 0.001) and was managed by device retrieval or by crushing the stent. CONCLUSIONS: The most common failure mechanisms of covered stents are failure of delivery, stent dislodgement, and failure to seal the perforation. Failure of delivery was more common with Graftmaster, while stent dislodgement was more common with PK Papyrus. Further improvements in covered stent design are needed to optimize deliverability and minimize the risk of complications.

Adoptability and accuracy of point-of-care ultrasound in screening for valvular heart disease in the primary care setting.

PURPOSE: Despite continued efforts, a majority of patients with valvular heart disease (VHD) remain undiagnosed and untreated. This study aimed to assess the adoptability and accuracy of point-of-care handheld echocardiographic assessments (POCE) in the primary care setting. METHODS: Eleven previously untrained primary care providers were trained to use the Vscan Extend (GE, WI) POCE to assess VHD, left ventricular function (LVEF), and major extra-cardiac findings. Their assessments were compared to those of three blinded expert readers. A total of 175 patients underwent POCE assessments which were evaluated using Kappa statistics (κ) together with their estimated standard error, p value, and 95% CI bounds. RESULTS: Each patient had a mean of 3.3 ± 1.1 (±SD) assessments performed. Identical or nearly identical agreement between previously untrained primary providers and expert readers was evident for the diagnosis of tricuspid regurgitation, mitral regurgitation, pericardial effusion, and volume status. These agreements were strongest in apical long axis (κ = 1, p < 0.001) and parasternal long and short axis views (κ > =0.82 p < 0.001), though agreement remained robust in apical 4-chamber views (κ ≥ 0.76). The agreements in LVEF assessment were identical in the apical long axis view (κ = 1, p < 0.001) and robust in the remaining 3 views (κ > =0.66, p < 0.001). The assessments of aortic stenosis (parasternal/long, κ = 0.42, and parasternal/short, κ = 0.47, both p < 0.001) were weak in their agreement. CONCLUSION: Compared to expert echocardiography readers, the untrained providers' use of POCE for VHD shows high user adoptability and diagnostic accuracies in the primary care setting.

Adverse Events With Intravascular Lithotripsy After Peripheral and Off-Label Coronary Use: A Report From the FDA MAUDE Database.

BACKGROUND: Currently only the peripheral intravascular lithotripsy (IVL) device is approved for use in the United States. We queried the United States Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database from January 1, 2016 to December 14, 2020 for all reports of adverse events and modes of failure related to the peripheral IVL device, when used for on- and off-label indications. There were 20 reports of use in peripheral artery disease interventions and 3 reports of off-label use in coronary interventions. Device malfunction in 13 of 23 patients (56.5%) was the most common adverse event reported. Partial balloon or catheter dislodgment was the most common mode of IVL device failure in 12 of 20 patients (60%), followed by balloon rupture in 3 of 20 patients (15%). Coronary use was rare, and associated with balloon perforation in 1 of 3 patients, bradycardia in 1 of 3 patients, and aortocoronary dissection in 1 of 3 patients. In summary, IVL use carries risk of complications; hence, continued vigilance and postmarketing monitoring are warranted.

Conventional Risk Factors, Telomere Length, and Ischemic Heart disease: Insights into the Mediation Analysis.

Telomere length is regarded as a potential biomarker of biological ageing and is associated with various age-related diseases, such as ischemic heart disease (IHD), myocardial infarction, peripheral vascular disease, and cancer. As there is a paucity of study that deals with this influence, this study aimed to assess how the cardiovascular risk factors influence the risk of IHD by performing mediation analysis. A total of 407 males were included in the study. IHD was diagnosed through echocardiography and coronary angiography by determining the number of coronary vessels involved. Demographic data, clinical history, and laboratory investigations such as random blood sugar (RBS), fasting lipid profile, serum creatinine, and serum urea levels of all the subjects were measured and recorded. Serum uric acid and blood urea nitrogen (BUN) levels were significantly higher in IHD subjects compared to non-IHD subjects (P < 0.05). Body mass index (BMI), glycosylated hemoglobin (HbA1c), RBS, serum uric acid, serum creatinine, BUN, total cholesterol, triglycerides, and telomere length significantly differed between subjects with and without IHD (P < 0.05). Further, telomere length (P < 0.001), BMI (P < 0.001), and total cholesterol level (P < 0.001) were risk factors that significantly affected the incidence of IHD, as proved by logistic regression. It indicates that shorter telomeres contribute to increased risk of IHD, influenced by BMI, HbA1c, BUN, total cholesterol levels, and RBS (P < 0.001). The study established a link between telomere shortening, conventional risk factors, and IHD; moreover, the study takes care in the role of mediation analysis which is a novel idea as little is done in this area of biostatistics with telomere length. Overall, this further establishes that telomeres length might serve as the promising biomarkers in predicting the risk of IHD.

Comparison of distal radial access versus standard transradial access in patients with smaller diameter radial Arteries(The distal radial versus transradial access in small transradial ArteriesStudy: D.A.T.A - S.T.A.R study).

AIMS: To evaluate safety and efficacy of distal right radial access (DRRA) compared to right radial access (RRA), for coronary procedures, in patients with smaller diameter radial arteries (SDRA) (radial artery diameter (RAD) < 2.1 mm). METHODS AND RESULTS: This is a retrospective analysis of safety and efficacy of DRRA Vs. RRA in patients undergoing coronary procedures at our cardiac catheterization laboratories over a 10- month period between September 2017 and June, 2018 (first 5 calendar months with RRA-first; next 5 calendar months with DRRA-first). All patients underwent pre-procedure ultrasound of arm arteries. All patients had RAD<2.1 mm (mean RAD 1.63 ± 0.27 mm; RAD≤1.6 mm in 73.5%). Baseline characteristics were similar between groups. Primary end-point of puncture success was significantly lower in DRRA vs RRA group [79.5% vs 98.5%, p < 0.0001]. Puncture success was also lower in the subgroup of patients with RAD <1.6 mm Vs. ≥ 1.6 mm in the DRRA group (p < 0.0001). The secondary end-point of puncture time was significantly higher (2.1 ± 1.4 min vs. 1.0 ± 0.45 min, p < 0.00001) in the DRRA Vs. RRA group. The occurrence of vascular access site complications (including access site hematomas), radial artery occlusion (RAO) and distal RAO at day 1 and day 30 were similar between RRA and DRRA groups.Non-vascular access-site complication was seen only in the DRRA group. CONCLUSION: DRRA is a safe and effective access for coronary procedures; though technically challenging in patients with SDRA (RAD<2.1 mm; mean RAD 1.63 ± 0.27 mm), with lower puncture success and higher puncture time compared to RRA.

Intravascular lithotripsy for stent under-expansion: Panacea or Pandora's box?

Balloon undilatable lesions are common and can be challenging to treat, especially within stents, and require a systematic, algorithmic approach. Stent under-expansion is usually treated with high-pressure balloon inflations, followed by plaque modification balloons, laser with contrast, orbital or rotational atherectomy, and subintimal crossing with coronary artery bypass graft being the ultimate solution is all techniques fail to expand the stent. Intravascular Lithotripsy (IVL) appears to be an easy to use and effective tool for treating stent under-expansion, but further study is needed to confirm its efficacy and (acute and long-term) safety.

Post-the SAFARI STEMI study: Is there still a debate on radial vs. femoral access in STEMI?

Despite the seminal trials on radial versus femoral access for percutaneous coronary intervention (PCI) in ST elevation myocardial infarction (STEMI) showing reduced bleeding, major adverse cardiovascular events and mortality; these outcomes were attributed by some to low usage of bivalirudin and an unnecessarily higher dose of Heparin, combined with high usage of GP IIb/IIIa inhibitors, as well as to the use of larger bore catheters in the femoral groups. To prove the point, a study comparing TF with TR access was mooted( Lee et al., 2013) 3; with bivalirudin instead of heparin, preferably with use of potent oral anti-platelets instead of GP IIb/IIIa inhibitors; and femoral vascular closure devices, ostensibly, to assess outcomes based on 'access-site alone'. With this intent, the SAFARI STEMI study was designed. In this article we discuss some of the major short-comings of this trial which raise significant questions on its results.

Socioeconomic Status and Differences in the Management and Outcomes of 6.6 Million US Patients With Acute Myocardial Infarction.

Little is known about the impact of socioeconomic status (SES) on management strategies and in-hospital clinical outcomes in patients with acute myocardial infarction (AMI) and its subtypes, and whether these trends have changed over time. All AMI hospitalizations from the National Inpatient Sample (2004 to 2014) were analyzed and stratified by zip code-based median household income (MHI) into 4 quartiles (poorest to wealthiest): 0th to 25th, 26th to 50th, 51st to 75th, and 76th to 100th. Logistic regression was performed to examine the association between MHI and AMI management strategy and in-hospital clinical outcomes. A total of 6,603,709 AMI hospitalizations were analyzed. Patients in the lowest MHI group had more co-morbidities, a worse cardiovascular risk factor profile and were more likely to be female. Differences in receipt of invasive management were observed between the lowest and highest MHI quartiles, with the lowest MHI group less likely to undergo coronary angiography (63.4% vs 64.3%, p <0.001) and percutaneous coronary intervention (40.4% vs 44.3%, p <0.001) compared with the highest MHI group, especially in the STEMI subgroup. In multivariable analysis, the highest MHI group experienced better outcomes including lower risk (adjusted odds ratio; 95% confidence intervals) of mortality (0.88; 0.88 to 0.89), MACCE (0.91; 0.91 to 0.92) and acute ischemic stroke (0.90; 0.88 to 0.91), but higher all-cause bleeding (1.08; 1.06 to 1.09) in comparison to the lowest MHI group. In conclusion, the provision of invasive management for AMI in patients with lower SES is less than patients with higher SES and is associated with worse in-hospital clinical outcomes. This work highlights the importance of ensuring equity of access and care across all strata SES.

Safety of transradial access compared to transfemoral access with hemostatic devices (vessel plugs and suture devices) after percutaneous coronary interventions: A systematic review and meta-analysis.

OBJECTIVES: Comparing the safety of transradial access (TRA) and conventional hemostasis with transfemoral access (TFA) and vascular closure devices (vessel plugs and suture devices) in patients undergoing percutaneous coronary interventions. BACKGROUND: TRA for PCIs is associated with fewer bleeding and vascular complications compared with TFA. Vascular closure devices (VCD) are often used post TFA to establish early hemostasis and mitigate bleeding risk. However, the comparative efficacy of TRA and TFA with VCDs remains controversial. METHOD: Electronic database were systematically searched for all pertinent studies from inception through January 2020. Randomized studies, registry data, and abstracts published in peer-reviewed indexed journals were included. The short-term outcomes: major bleeding, vascular complications, and closure device failure were evaluated. Random-effects model was used to pool individual study results. RESULTS: Twelve studies (8 observational, 4 randomized) including 7,961 patients (TRA: 3,121 patients, TFA and vessel plugs: 3,157 patients, TFA & suture devices: 1,683 patients) were included in the analysis. Major bleeding was significantly lower with TRA compared with TFA and vessel plugs (odds ratio [OR] 0.22, 95%CI 0.11-0.44, p < .00001) and TFA & suture devices (OR 0.12, 95%CI 0.05-0.28, p < .00001). Vascular complications were significantly lower with TRA compared to TFA and vessel plugs (OR 0.25, 95%CI 0.13-0.49, p < .0001) and TFA & suture devices (OR 0.13, 95%CI 0.04-0.41, p = 0.0005). Rates of closure device failure were lower for TRA compared to TFA & suture devices (OR 0.13, 95%CI 0.04-0.41, p = .0005), but similar to TFA & vessel plugs (OR 0.23, 95%CI 0.01-4.28, p = .33), although confidence intervals were wide. All analysis revealed a low to moderate level of heterogeneity. CONCLUSION: TRA with conventional hemostasis is safer than TFA with hemostasis via vessel plugs or suture devices and should be considered best practice.