Outcomes With Limus- vs Paclitaxel-Coated Balloons for Percutaneous Coronary Intervention: Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Randomized controlled trials (RCTs) examining the outcomes with limus drug-coated balloons (DCBs) vs paclitaxel DCBs were small and underpowered for clinical endpoints. OBJECTIVES: This study sought to compare the angiographic and clinical outcomes with limus DCBs vs paclitaxel DCBs for percutaneous coronary intervention (PCI). METHODS: An electronic search of Medline, EMBASE, and Cochrane databases was performed through January 2024 for RCTs comparing limus DCBs vs paclitaxel DCBs for PCI. The primary endpoint was clinically driven target lesion revascularization (TLR). The secondary endpoints were late angiographic findings. Summary estimates were constructed using a random effects model. RESULTS: Six RCTs with 821 patients were included; 446 patients received a limus DCB, and 375 patients received a paclitaxel DCB. There was no difference between limus DCBs and paclitaxel DCBs in the incidence of TLR at a mean of 13.4 months (10.3% vs 7.8%; risk ratio [RR]: 1.32; 95% CI: 0.84-2.08). Subgroup analysis suggested no significant interaction among studies for de novo coronary lesions vs in-stent restenosis (Pinteraction = 0.58). There were no differences in the risk of major adverse cardiovascular events, cardiac mortality, or target vessel myocardial infarction between groups. However, limus DCBs were associated with a higher risk of binary restenosis (RR: 1.89; 95% CI: 1.14-3.12), late lumen loss (mean difference = 0.16; 95% CI: 0.03-0.28), and a smaller minimum lumen diameter (mean difference = -0.12; 95% CI: -0.22 to -0.02) at late follow-up. In addition, late lumen enlargement occurred more frequently (50% vs 27.5%; RR: 0.59; 95% CI: 0.45-0.77) with paclitaxel DCBs. CONCLUSIONS: Among patients undergoing DCB-only PCI, there were no differences in the risk of clinically driven TLR and other clinical outcomes between limus DCBs and paclitaxel DCBs. However, paclitaxel DCBs were associated with better late angiographic outcomes. These findings support the need for future trials to establish the role of new-generation limus DCBs for PCI.

Management of an Inadvertently Placed Transarterial Pacemaker Lead in the Left Ventricle: A Step-by-step Approach.

Inadvertent lead misplacement in the left ventricle can lead to thromboembolic events, valvular damage, and endocarditis. We present a case of an inadvertently placed transarterial pacemaker lead in the left ventricle in a patient who underwent percutaneous lead removal. After a multidisciplinary team discussion involving cardiac electrophysiology and interventional cardiology as well as a discussion of treatment options with the patient, it was decided to proceed with pacemaker lead removal with the Sentinel™ Cerebral Protection System (Boston Scientific, Marlborough, MA, USA) to prevent thromboembolic events. The patient tolerated the procedure well without post-procedural complications and was discharged the next day on oral anticoagulation. We also present a step-by-step approach to perform lead removal with the use of Sentinel™, emphasizing mitigating the stroke and bleeding risks in this patient setting.

Left Ventricular Outflow Obstruction From Mechanical Circulatory Support in Critical Aortic Stenosis: A Cautionary Tale.

We submit a cautionary tale of a patient with critical aortic stenosis presenting with acute myocardial infarction and cardiogenic shock, who underwent balloon aortic valvuloplasty, insertion of a transvalvular left percutaneous ventricular assist device and high-risk percutaneous coronary intervention, with a post-operative course complicated by outflow obstruction from the device itself. (Level of Difficulty: Intermediate.).

Outcomes with catheter-directed thrombolysis vs. catheter-directed embolectomy among patients with high-risk pulmonary embolism: a nationwide analysis.

AIMS: To examine the shot-term outcomes with catheter-directed thrombolysis (CDT) vs. catheter-directed embolectomy (CDE) for high-risk pulmonary embolism (PE). METHODS AND RESULTS: The Nationwide Readmissions Database was utilized to identify hospitalizations with high-risk PE undergoing CDE or CDT from 2016 to 2019. The main outcome was all-cause in-hospital mortality. Propensity score matching was used to compare the outcomes in both groups. Among 3216 high-risk PE hospitalizations undergoing catheter-directed interventions, 868 (27%) received CDE, 1864 (58%) received CDT, and 484 (15%) received both procedures. In the unadjusted analysis, the rate of all-cause in-hospital mortality was not different between CDE and CDT (39.6% vs. 34.2%, P = 0.07). After propensity score matching, there was no difference in the incidence of in-hospital mortality [adjusted odds ratio (aOR): 1.28, 95% confidence interval (CI): 0.95, 1.72, P = 0.10], intracranial haemorrhage (ICH) (adjusted OR 1.57, 95% CI: 0.75, 3.29, P = 0.23), or non-ICH bleeding (aOR: 1.17, 95% CI: 0.85, 1.62, P = 0.33). There were no differences in the length of stay, cost, and 30-day unplanned readmissions between both groups. CONCLUSION: In this contemporary observational analysis of patients admitted with high-risk PE undergoing CDT or CDE, the rates of in-hospital mortality, ICH, and non-ICH bleeding events were not different.

Trends and Outcomes of Interhospital Transfer for High-Risk Acute Pulmonary Embolism: A Nationwide Analysis.

Background: Data on outcomes of patients with high-risk acute pulmonary embolism (PE) transferred from other hospitals are scarce. Methods: We queried the Nationwide Readmissions Database for admissions who were ≥18 years old, and with a primary discharge diagnosis of acute high-risk PE between the years 2016 and 2019. The main outcome of interest was the difference in all-cause in-hospital mortality between patients admitted directly to small/medium hospitals; patients admitted directly to large hospitals; and patients transferred to large hospitals. Results: Among 11,341 weighted hospitalizations with high-risk PE, 631 (5.6%) patients were transferred to large hospitals. There was no significant change in the rates of transfer during the study period. Transferred patients were younger and had a higher prevalence of comorbidities. They were more likely to present with saddle PE and cor pulmonale and were more likely to receive advanced therapies. In-hospital mortality was not different between patients transferred to large hospitals and those admitted directly to large hospitals (adjusted odd ratio [OR] 1.11, 95% confidence interval [CI] 0.81, 1.54) as well as between patients transferred to large hospitals and those admitted directly to small/medium hospitals (aOR 1.28, 95% CI 0.92, 1.76). The rates of major bleeding and cardiac arrest were higher among transferred patients. Admissions for transferred patients were associated with higher cost and longer length of stay. Conclusion: Transferred patients with high-risk PE were more likely to receive advanced therapies. There was no difference in-hospital mortality rates compared with patients admitted directly to the large or small/medium hospitals.

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.

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.

Analysis of Subjective and Objective Screening Techniques as Predictors of Safety for Radial Artery Intervention.

BACKGROUND: There is no currently accepted standard in safety evaluation for radial artery intervention. We sought to compare the accuracy of various subjective and objective screening techniques in predicting safety for radial artery intervention. METHODS: Fifty-four patients in a prospective cohort study at a single institution underwent subjective Allen's test, objective Barbeau test, and several objective hand ultrasound techniques to assess safety for radial artery intervention. These results were then compared to the gold standard of conventional hand angiography to document complete palmar arch. Statistical analysis including sensitivity, specificity, positive predictive values, negative predictive values, and accuracy were calculated. RESULTS: Compared to hand angiography, the subjective Allen's test and the objective Princeps Pollicis Artery ultrasound demonstrated the comparable levels of sensitivity (100% vs. 96.7%, respectively), specificity (100% vs. 100%, respectively), and accuracy (97.2% vs. 97.1%, respectively). The objective Barbeau test demonstrated similar results (sensitivity of 100%, accuracy of 98.2%) with the exception of a lower specificity (50%). CONCLUSIONS: There is no currently accepted standard in safety evaluation for radial artery intervention. However, preliminary data suggest that certain subjective and objective techniques such as Allen's testing, Princeps Pollicis artery ultrasound, and Barbeau testing are comparable options in predicting palmar arch patency.

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.

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.

Endothelin as a clinical target in the treatment of systemic hypertension.

Endothelin is a potent vasoconstrictor substance that also can exert proliferative, inflammatory, and fibrotic changes in blood vessels and other organs. It acts on tissues in a paracrine and autocrine fashion, with local production and regulation occurring in both endothelial and nonendothelial cells. Endothelin stimulation of ETA and ETB receptors results in different and often opposing effects, which under physiologic conditions, establishes a balance that contributes to the regulation of vascular tone and blood pressure. Dysregulation of the endothelin system can induce or mediate endothelial dysfunction and organ damage in systemic hypertension (HTN), effects which may be ameliorated by endothelin antagonists. Endothelin receptor antagonists are currently being used in the treatment of pulmonary HTN. Both selective and dual-acting endothelin receptor blockers can also reduce systemic blood pressure in animal models and in hypertensive patients. Clinical trials evaluating the efficacy and safety of these agents are underway, and show potential as a new class of antihypertensives. Studies are also in progress with a single moiety dual angiotensin-endothelin A receptor antagonist, which is being evaluated in HTN. Issues that need to be addressed include the net contribution of endothelin in the pathophysiology of HTN, its interaction with other neurohormonal systems such as the renin-angiotensin-aldosterone system, and the clinical demonstration of the effect of endothelin receptor antagonism on end-organ damage in hypertensive patients.