Acute Device-Related Thrombus Elimination During Transcatheter Edge-to-Edge Repair Via Vacuum Catheter Aspiration.

We describe a rare complication of intraprocedural spontaneous thrombus formation on a transcatheter edge-to-edge repair (MitraClip; Abbott Laboratories) device in a hypercoagulable yet adequately anticoagulated patient. We also outline the novel use of a vacuum (Penumbra) aspiration system, which resulted in rapid and effective thrombus elimination.

Disparities in Drug-Eluting Stent Utilization in Patients With Acute ST-Elevation Myocardial Infarction: An Analysis of the National Inpatient Sample.

The superiority of drug-eluting stents (DES) compared with bare-metal stents (BMS) is well-established, but data regarding DES use in ST-elevation myocardial infarction (STEMI) as a function of race is limited. Our goal was to examine stent utilization patterns and disparities based on race, sex, and insurance status in patients with STEMI undergoing percutaneous coronary intervention. The National Inpatient Sample database was used to retrospectively compare DES vs BMS use in patients admitted with STEMI from 2009 to 2018. Multivariable logistic regression was performed to assess the independent predictors of DES use. DES utilization increased significantly from 62.8% in 2009 to 94.0% in 2018. However, African Americans were less likely to receive a DES (odds ratio [OR] .82, 95% confidence interval [CI] .77-.87) compared with Caucasians. Women were more likely to undergo DES implantation (OR 1.07, 95% CI 1.05-1.10). Patients insured by Medicaid (OR .84, 95% CI .80-.89) and those classified as Self-pay (OR .63, 95% CI .61-.66) were less likely to undergo DES implantation compared to those with private insurance (OR 1.33, 95% CI 1.29-1.38). Disparities based on race and insurance status continue to persist despite a significant increase in DES utilization in STEMI patients across the identified subgroups.

Radiofrequency Ablation for Prevention of Outflow Tract Obstruction in Percutaneous Mitral Valve-in-Valve Replacement.

Left ventricular outflow tract obstruction (LVOTO) can complicate percutaneous mitral valve replacement and may preclude patients considered high surgical risk from transcatheter therapies. We report a case of mitral valve-in-valve procedure in a patient at high risk for LVOTO. (Level of Difficulty: Advanced.).

In-Hospital Outcomes of Surgical Aortic Valve Replacement at Transcatheter Valve Implantation Centers.

The availability of transcatheter aortic valve implantation (TAVI) has led to the development of a multidisciplinary team, the "heart team," at institutions offering both TAVI and surgical aortic valve replacement (SAVR). Whether this approach has improved in-hospital outcomes in patients who underwent SAVR at institutions offering TAVI versus those not offering TAVI is largely unknown. The National Inpatient Sample (2011 to 2018) was used to study trends in visits for SAVR and in-hospital outcomes at TAVI and non-TAVI centers. Survey estimation commands were used to determine weighted national estimates. There were 559,365 inpatient visits during 2011 to 2018 for aortic valve replacement, with 65.9 ± 0.8% and 34.0 ± 0.8% at TAVI and non-TAVI centers, respectively. Patients who underwent SAVR at TAVI hospitals had more co-morbidities and were less likely to receive mechanical prosthesis (24.7 ± 0.5% vs 35.5 ± 0.6%). Adjusted in-hospital mortality was lower among any SAVR (odds ratio 0.84, 95% confidence interval 0.75 to 0.94) and isolated SAVR (odds ratio 0.83, 95% confidence interval 0.70 to 0.98) recipients at TAVI centers. There was no difference in the incidence of stroke, permanent pacemaker placement, and acute kidney injury after SAVR in TAVI and non-TAVI centers. Although patients who underwent SAVR at TAVI centers had more co-morbidities, in-hospital mortality was lower at TAVI centers than non-TAVI centers. This may be attributable to several factors, including but not limited to experience, resource availability, and operative volumes and the use of the heart team.

Sex Disparities in the Treatment of Aortic Stenosis and Related Outcomes: An Analysis of the National Inpatient Sample.

INTRODUCTION: The impact of transcatheter aortic valve replacement (TAVR) on sex disparities has not been well established. This study sought to examine the impact of sex on outcomes following aortic valve replacement (AVR) for aortic stenosis (AS) in the era of routine TAVR. METHODS: We performed a cross-sectional analysis of the National Inpatient Sample (2009-18) to study AS visits for all AVR and in-hospital outcomes as a function of sex. Survey estimation commands were used to provide national estimates. RESULTS: There were an estimated 431,344 surgical AVR (SAVR) and 189,137 TAVR inpatient visits. Mortality was higher in women after SAVR (3.8% ± 0.1 vs. 2.7% ± 0.07, p < 0.001) and TAVR (2.4% ± 0.1 vs. 1.7% ± 0.1, p < 0.001) compared to men. Female patients undergoing SAVR had higher rates of permanent pacemaker (PPM) implantation, stroke, and bleeding (5.9% ± 0.1 vs. 5% ± 0.1, 2.8% ± 0.1 vs. 2.3% ± 0.07, and 37.8% ± 0.8 vs. 29.8% ± 0.6; p < 0.001, respectively) but lower rates of acute kidney injury (AKI) (16.4% ± 0.3 vs. 20.3% ± 0.3, p < 0.001). Women undergoing TAVR had higher rates of stroke and bleeding (2.4% ± 0.1 vs. 1.6% ± 0.09 and 28.7% ± 0.6 vs. 22% ± 0.5; p < 0.001, respectively) but lower rates of PPM and AKI (9.5% ± 0.3 vs. 10.7% ± 0.2 and 11.3% ± 0.3 vs. 13.4% ± 0.3; p < 0.001, respectively). Compared with isolated SAVR, isolated TAVR was associated with lower mortality in women during 2016-18, both after multivariable adjustment (OR = 0.40; 95% CI, 0.27-0.60) and propensity matching (mean difference 0.66% ± 0.2); however, there was no difference in men. CONCLUSION: Although women continue to have higher in-hospital mortality following both TAVR and SAVR as compared to men, TAVR is associated with a lower in-hospital mortality in women compared to SAVR. Thus, TAVR may represent a potential intervention to narrow the sex-based disparities in the management of AS.

TAVR in an XXXL annulus (1057 mm2 ) with type I bicuspid aortic valve.

We report the largest annulus (>1000 m2 ) treated with transcatheter aortic valve replacement to date. It highlights the unique challenges in planning, sizing, and deployment considerations in the setting of a very large and altered geometry of a bicuspid aortic valve.

Contemporary trends and in-hospital outcomes of mechanical and bioprosthetic surgical aortic valve replacement in the United States.

INTRODUCTION: The choice between a mechanical versus a bioprosthetic valve in aortic valve replacement (AVR) is based on life expectancy, bleeding risk and comorbidities, since bioprosthetic AVR (bAVR) are associated with a more rapid structural deterioration compared to mechanical AVR (mAVR). The impact of widespread transcatheter valve replacements, on the decision to use bAVR versus mAVR, in the contemporary era and subsequent outcomes remain to be determined. METHODS: The National Inpatient database (2009-2018) was used to study trends in admissions for bAVR and mAVR and in-hospital mortality and outcomes over time. Survey estimation commands were used to determine weighted national estimates. RESULTS: There were 700,896 ± 18,285 inpatient visits for AVR with 70.1% (95% CI 69.2%-71.1%) and 29.9% (95% CI 28.9%-30.8%) visits for bAVR and mAVR, respectively. Those undergoing bAVR were significantly older (bAVR [69.8 years] vs. mAVR [62.7 years] p < .001]. The rates of mAVR decreased across all age groups during the study period (ptrend < .001), including patients ≤50 years (ptrend < .001). In-hospital mortality for mAVR recipients was higher, both after multivariable adjustment (OR 1.35 95% CI 1.26-1.45 p < .001) and propensity matching (mean difference 0.846% ± 0.19%). CONCLUSION: In the contemporary era, the utilization of mAVR has decreased across all age groups, including those younger than 50 years old. Although mAVR recipients were healthier with less comorbidities, inpatient mortality was higher after mAVR compared to bAVR. In addition to understanding causes for higher in-hospital mortality after mAVR, future research should focus on developing transcatheter valve replacement friendly bAVR.

Racial disparities in the treatment of aortic stenosis: Has transcatheter aortic valve replacement bridged the gap?

BACKGROUND: Racial disparities in outcomes and utilization of surgical aortic valve replacement (SAVR) for the treatment of severe aortic stenosis (AS) is well known. While transcatheter aortic valve replacement (TAVR) has become more widespread, its impact on racial disparities remains unclear. OBJECTIVES: Our goal was to assess the utilization of SAVR and TAVR and their clinical outcomes among various racial groups. METHODS: The National Inpatient database (2009-2015) was used to study the racial distribution of admissions for SAVR and TAVR, and their impact on inpatient outcomes. Survey estimation commands were used to determine weighted national estimates. RESULTS: There were 3,445,267; 294,108; and 52,913 inpatient visits for AS, SAVR, and TAVR, respectively. SAVR visits were 86% White, 3.8% Black, 5.5% Hispanic, 1.2% Asian/Pacific Islander (A/PI), 0.4% Native American (NA), and 2.9%; TAVR were 87.7% White, 3.7% Black, 3.8% Hispanic, 1.0% A/PI, 0.2% NA, and 3.5% Other while AS visits were 83.7% White, 6.7% Black, 5.3% Hispanic, 1.7% A/PI, 0.4% NA, and 2.2% Other. Racial minorities generally had more co-morbidities compared with Whites. After SAVR, Black patients had a higher unadjusted inpatient mortality than Whites, however, there was no difference after adjustment for other variables. A/PI were more likely to require a permanent pacemaker after SAVR. Need for blood transfusion was significantly higher among the minorities compared with Whites, except for NA, but there were no racial differences in stroke rates. There was no difference in inpatient mortality, pacemaker implantation, stroke, and bleeding after TAVR, but acute kidney injury occurred more often in Hispanics, A/PI, and "others" compared with Whites. CONCLUSIONS: Racial disparities in the treatment of AS continues in the contemporary era; however it was found that TAVR resulted in comparable inpatient outcomes, despite higher comorbidities, and adverse socioeconomic factors in minorities.

Ultrathin biodegradable polymer sirolimus-eluting stent versus contemporary durable polymer everolimus-eluting stent for percutaneous coronary intervention: a meta-analysis of randomized trials.

INTRODUCTION: Improvements in coronary drug-eluting stent technology has focused on reducing the long-term complications associated with the effects of the residual footprint on the vessel wall. Although many of the newer stents have exhibited noninferiority to the durable polymer everolimus-eluting stent (DP-EES), they have yet to exhibit clear superiority. We compared the performance of the latest ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES) to DP-EES. METHODS: We searched the electronic databases for randomized controlled trials comparing BP-SES to DP-EES. A random effect meta-analysis was performed using the Poisson regression model. The primary end point was target lesion failure (TLF), a composite of target vessel myocardial infarction (TVMI), cardiac death and target lesion revascularization (TLR). RESULTS: There was no difference between the stents in stent thrombosis [incidence rate ratio (IRR) = 0.79, 95% confidence interval (CI) 0.58-1.06), TLR (IRR = 0.88, 95% CI 0.57-1.38), TVMI (IRR = 0.79, 95% CI 0.61-1.01), cardiac death (IRR = 0.99, 95% CI 0.76-1.29) and target vessel failure (IRR = 0.82, 95% CI 0.64-1.06). In addition, there was no difference in TLF (IRR = 0.82, 95% CI 0.64-1.06). There was evidence of reduced TLF in small vessels with BP-SES based on definition used (defined as ≤2.75 mm; IRR 0.64, 95% CI 0.46-0.91 versus ≤3 mm; IRR 1.11, 95% CI 0.90-1.36). CONCLUSION: In our study, the performance of the latest generation BP-SES was comparable to DP-EES but failed to show superiority. The possible benefit in patients with small vessels should be explored future trials.

Expedited MitraClip: Rapid Evaluation, Treatment, and Discharge in the COVID-19 Era.

Undertreatment of patients with severe mitral regurgitation (MR) has been exaggerated during the coronavirus disease of 2019 (COVID-19) pandemic. Expedited workup and shortened post-procedural hospital stay after percutaneous mitral valve repair (PMVR) would be incredibly helpful to relieve the constrain in the era of the COVID-19 pandemic and immediately afterward. We report a patient who underwent PMVR with a simplified pre-operative workup, a shortened hospital stay, and expedited discharge.

Does the Presence of Significant Mitral Regurgitation prior to Transcatheter Aortic Valve Implantation for Aortic Stenosis Impact Mortality? - Meta-Analysis and Systematic Review.

BACKGROUND: Mitral regurgitation (MR) is commonly encountered in patients with severe aortic stenosis (AS). However, its independent impact on mortality in patients undergoing transcatheter aortic valve implantation (TAVI) has not been established. METHODS: We performed a systematic search for studies reporting characteristics and outcome of patients with and without significant MR and/or adjusted mortality associated with MR post-TAVI. We conducted a meta-analysis of quantitative data. RESULTS: Seventeen studies with 20,717 patients compared outcomes and group characteristics. Twenty-one studies with 32,257 patients reported adjusted odds of mortality associated with MR. Patients with MR were older, had a higher Society of Thoracic Surgeons score, lower left ventricular ejection fraction, a higher incidence of prior myocardial infarction, atrial fibrillation, and a trend towards higher NYHA class III/IV, but had similar mean gradient, gender, and chronic kidney disease. The MR patients had a higher unadjusted short-term (RR = 1.46, 95% CI 1.30-1.65) and long-term mortality (RR = 1.40, 95% CI 1.18-1.65). However, 16 of 21 studies with 27,777 patients found no association between MR and mortality after adjusting for baseline variables. In greater than half of the patients (0.56, 95% CI 0.45-0.66) MR improved by at least one grade following TAVI. CONCLUSION: The patients with MR undergoing TAVI have a higher burden of risk factors which can independently impact mortality. There is a lack of robust evidence supporting an increased mortality in MR patients, after adjusting for other compounding variables. MR tends to improve in the majority of patients post-TAVI.

Inpatient mortality and its predictors after pericardiocentesis: An analysis from the Nationwide Inpatient Sample 2009-2013.

BACKGROUND: National registries have provided data on in-hospital outcomes for several cardiac procedures. The available data on in-hospital outcomes and its predictors after pericardiocentesis are mostly derived from single center studies. Furthermore, the outcomes after pericardiocentesis for iatrogenic pericardial effusion and the impact of procedural volume on in-hospital outcomes in the United States are largely unknown. METHODS: We used national inpatient database files for the years 2009-2013 to estimate the inpatient outcomes after pericardiocentesis in all-comers and in the subgroups with iatrogenic effusion. We also studied the impact of hospital procedural volume, among other predictors, on inpatient mortality. RESULTS: About 64,070 (95%CI 61 008-67 051) pericardiocentesis were performed in the United States during 2009-2013. Of these, 57.15% (56.02-58.26%) of the pericardiocentesis were in hemodynamically unstable patients. Percutaneous cardiac procedures were performed in 17.7% of patients (percutaneous coronary intervention (PCI) 4.02%, electrophysiologic procedures 13.58%, and structural heart intervention (SHI) 0.76%). Overall inpatient mortality was 12.30% (95%CI 11.66-12.96%). Inpatient mortality after PCI, electrophysiologic procedures, SHI and cardiac surgery were 27.67% (95%CI 24-31.67%), 7.8% (95%CI 6.67-9.31%), 22.36% (95%CI 15.06-31.85%) and 18.97% (95%CI 15.84-22.57%), respectively. There was an inverse association between hospital procedural volume and inpatient mortality, with a mortality of 14.01% (12.84-15.26%) at the lowest and 10.82% (9.44-12.37%) at highest quartile hospitals by procedure volume (ptrend = 0.001). CONCLUSION: The inpatient mortality after pericardiocentesis is high, particularly when associated with PCI and SHI.

A Meta-Analysis Comparing Percutaneous Coronary Intervention With Drug-Eluting Stents Versus Coronary Artery Bypass Grafting in Unprotected Left Main Disease.

Coronary artery bypass grafting (CABG) is the preferred revascularization strategy for unprotected left main disease (UPLMD). Multiple small-scale trials and registry data showed that percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is a noninferior strategy with a Class IIa American College of Cardiology/American Heart Association recommendation in patients with high surgical risk and favorable anatomy. However, 2 recent large-scale randomized trials showed conflicting evidence. We conducted a meta-analysis of the existing data to compare outcomes of PCI with DES versus CABG for UPLMD. Four randomized and 8 nonrandomized trials involving 10,284 patients were included. Primary end point was composite of death, stroke, or myocardial infarction (MI) at 3 years or longer. Secondary end points were MACCE (Major Adverse Cardiac and Cerebrovascular Events) and its individual components (death, stroke, MI, or repeat revascularization). Mantel-Haenszel random effects model was used to calculate combined odds ratio for outcomes. A separate analysis of randomized data was also performed. There was no significant difference in primary composite outcome between PCI and CABG. However, MACCE was significantly higher in PCI, primarily driven by significantly high repeat revascularization. A subgroup analysis stratified by Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score showed that MACCE and repeat revascularization were not significantly different between PCI and CABG in low to intermediate SYNTAX score (<33), whereas they were significantly higher in PCI with higher SYNTAX score. Thus, although CABG remains the preferred method of treatment in UPLMD, PCI with DES can be considered as a reasonable alternative in patients with favorable anatomy and high surgical risk.

Late Incomplete stent apposition is associated with late/very late stent thrombosis: A meta-analysis.

BACKGROUND: There is a lingering controversy in the current literature about the impact of late incomplete stent apposition (LISA) on clinical outcomes, especially stent thrombosis (ST). Therefore, we aimed to synthesize the available evidence evaluating the association between LISA and adverse clinical outcomes. METHODS: We systematically searched electronic databases for studies reporting clinical outcomes in patients with and without LISA. Relevant study characteristics and clinical outcomes were extracted. Incidence rate ratios (IRR) and 95% Confidence Interval (CI) were computed. Sensitivity analyses were done. RESULTS: Sixteen studies with 4,946 patients; 666 patients with 20,035 patient-months follow up with LISA and 4,280 patients with 121,855 patient-months follow up without LISA were included. The estimated prevalence of LISA at follow up was 16% (95% CI 12-20%). The incidences of late/very late ST (IRR = 4.81, 95% CI 2.68-8.62) and myocardial infarction (MI) (IRR = 3.09, 95% CI 1.72-5.55) were significantly higher in the LISA group compared to patients without LISA. Subset analysis of studies reporting Academic Research Consortium definitive/probable ST (IRR = 4.98; 95% CI 2.51-9.89) and acquired LISA (IRR = 3.67, 95% CI 1.5-9.0) similarly showed increased risk of late/very late ST. The results of sensitivity analyses were consistent. There was no difference in cardiac death and target lesion revascularization. CONCLUSION: The presence of LISA at a follow up of 6-18 months after stent implantation is associated with a higher risk of late/very late ST and MI. Additional studies are required to establish a cause and effect, and inform the management strategy. © 2017 Wiley Periodicals, Inc.

Clinical Profile and Outcome of Newborns with Acute Kidney Injury in a Level 3 Neonatal Unit in Western India.

INTRODUCTION: Acute Kidney Injury (AKI) is a serious condition in neonatal care. It complicates the management necessitating the restrictive use of medications. AIM: To evaluate clinical profile, identify associated and prog-nostic factors in newborns with AKI. MATERIALS AND METHODS: This was a case control study done between January 2008 to January 2010. Total 1745 newborns were admitted, of which 74 babies had AKI. It was defined as serum creatinine >1.5mg/dl. Control group was selected randomly from the hospital numbers of the newborns derived from the electronic registry with serum creatinine below 1.5 mg/dl. Demographic variables like birth weight, gender, gestational age, admission age, growth restriction, Apgar scores, electrolyte levels; and common clinical conditions like asphyxia, sepsis, meningitis, persistent pulmonary hypertension, Necrotizing Enterocolitis (NEC), mechanical ventilation, congenital heart disease; were compared amongst the two groups. Information was obtained from the admission register, admission files, labor register of obstetrics and gynaecology department and electronic registry. Chi square/independent sample t-test as applicable and logistic regression were used to establish an association of various factors and outcome with AKI. RESULTS: The incidence of AKI in our study was 4.24%. Demographic variables more common in AKI group were inborn (p=0.011), male gender (p=0.032), term gestation (p=0.001), Appropriate for gestational age (0.001), higher birth weight (p<0.001), full term (p<0.001), sepsis (p<0.001), NEC (p=0.042), low ApGAR scores at one minute (p=0.011) and five minute (p=0.003). However, on multivariate logistic regression only male gender [Odds Radio (OR)=2.84, Confidence Interval (CI)=1.12-7.21] and Sepsis (OR=14.46, CI=4.5-46.46) were associated with AKI. Respiratory distress syndrome was more prevalent in the control group (p<0.003). No need of mechanical ventilation and absence of shock, improved the survival. CONCLUSIONS: AKI continues to be of clinical significance in neonatal intensive care. Further studies are needed to evaluate newer associations (like male gender and low APGAR scores).

Statin Use Mitigate the Benefit of Omega-3 Fatty Acids Supplementation-A Meta-Regression of Randomized Trials.

During last 2 decades, multiple studies have evaluated omega-3 polyunsaturated fatty acids (ω-3 PUFA) supplementation for cardiovascular prevention. The benefit found in previous studies was not demonstrated in more contemporary trials. We aimed to investigate effect of study characteristics, particularly concomitant statin therapy on results of randomized controlled trials. We systematically searched electronic databases for randomized controlled trials evaluating ω-3 PUFA supplementation and reporting clinical outcomes. A meta-analysis was performed using a random effect model, followed by a meta-regression of dose, docosahexaenoic acid/eicosapentaenoic acid (DHA/EPA) ratio, and duration of treatment and use of lipid-lowering/statin therapy in control group. Twenty-three studies with 77,776 patients (38,910 PUFA; 38,866 controls) were included. PUFA had no effect on total mortality [risk ratio (RR) = 0.96; 95% confidence interval (CI), 0.92-1.01] and myocardial infarction (RR = 0.87; 95% CI, 0.73-1.02), but marginally reduced cardiovascular mortality (RR = 0.93; 95% CI, 0.87-0.98). Lower control group statin use (b = 0.222, P = 0.027) and higher DHA/EPA (b = -0.105, P = 0.033) ratio was associated with higher reduction in total mortality. Duration and dose had no effect. None of the variables except duration had significant effect on reduction in cardiovascular mortality by PUFA supplementation. There was evidence of publication bias. Statin use may mitigate, and higher DHA/EPA ratio is associated with the beneficial effect of PUFA supplementation.