Mechanical Circulatory Support for High-Risk Percutaneous Coronary Intervention.

PURPOSE OF REVIEW: This review will focus on the indications of mechanical circulatory support (MCS) for high-risk percutaneous coronary intervention (PCI) and then analyze in detail all MCS devices available to the operator, evaluating their mechanisms of action, pros and cons, contraindications, and clinical data supporting their use. RECENT FINDINGS: Over the last decade, the interventional cardiology arena has witnessed an increase in the complexity profile of the patients and lesions treated in the catheterization laboratory. Patients with significant comorbidity burden, left ventricular dysfunction, impaired hemodynamics, and/or complex coronary anatomy often cannot tolerate extensive percutaneous revascularization. Therefore, a variety of MCS devices have been developed and adopted for high-risk PCI. Despite the variety of MCS available to date, a detailed characterization of the patient requiring MCS is still lacking. A precise selection of patients who can benefit from MCS support during high-risk PCI and the choice of the most appropriate MCS device in each case are imperative to provide extensive revascularization and improve patient outcomes. Several new devices are being tested in early feasibility studies and randomized clinical trials and the experience gained in this context will allow us to provide precise answers to these questions in the coming years.

Clinical profile and management of patients with acute pulmonary thromboembolism - a single centre, large observational study from India.

Acute pulmonary thromboembolism is associated with high mortality, similar to that of myocardial infarction and stroke. We studied the clinical presentation and management of pulmonary thromboembolism in the Indian population. An analysis of 140 patients who presented with acute pulmonary thromboembolism at a large volume center in India from June 2015 through December 2018 was performed. The mean age of our study population was 50 years with 59% being male. Comorbidities including deep vein thrombosis, diabetes mellitus, hypertension, and chronic obstructive pulmonary disease were present in 52.9%, 40%, 35.7% and 7.14% of patients, respectively. Out of 140 patients, 40 (28.6%) patients had massive pulmonary thromboembolism, 36 (25.7%) sub-massive pulmonary thromboembolism, and 64 (45.7%) had low-risk pulmonary thromboembolism. Overall, in-hospital mortality was 25.7%. Multivariate regression analysis found chronic kidney disease and pulmonary thromboembolism severity to be the only independent risk factors. Thrombolysis was performed in 62.5% of patients with a massive pulmonary thromboembolism and 63.9% of patients with a sub-massive pulmonary thromboembolism. In the massive pulmonary thromboembolism group, patients receiving thrombolytic therapy had lower mortality compared with patients who did not receive therapy (p=0.022), whereas this difference was not observed in patients in the sub-massive pulmonary thromboembolism group. We conclude that patients with acute pulmonary thromboembolism in India presented more than a decade earlier than our western counterparts, and it was associated with poor clinical outcomes. Thrombolysis was associated with significantly reduced in-hospital mortality in patients with massive pulmonary thromboembolism.

Meta-Analysis of Anticoagulation Therapy for the Prevention of Cardiovascular Events in Patients With Peripheral Arterial Disease.

Peripheral artery disease (PAD) remains a major cause of morbidity and future cardiovascular events despite advancement in the surgical interventions and optimal medical therapy. The aim of our study is to evaluate the efficacy and safety of anticoagulation (AC) therapy for reducing cardiovascular and limb events in patients with PAD. PUBMED, Medline, and Cochrane Library were searched through 2020 for randomized clinical trials comparing major adverse cardiovascular events (MACE) and risk of major bleeding (MB), between AC and standard of care (SOC) therapy, among patients with PAD. Meta-analysis was performed using weighted pooled absolute risk difference (RD) with 95% confidence interval (CI) and fixed effects model for overall and sub-groups of full dose (FD) and low dose (LD) AC therapies. Amongst 17,684 patients from 7 different studies, the addition of AC to SOC therapy was associated with MACE reduction (RD -0.022, 95% CI -0.033 to -0.012, p <0.001) and increased MB (RD 0.02, 95% CI 0.014 to 0.025, p <0.001). For FD, MACE reduction was (RD -0.021, 95% CI -0.042 to 0.001, p = 0.061) and MB (RD 0.036, 95% CI 0.025 to 0.047, p <0.001). For LD, MACE reduction was (RD -0.023, 95% CI -0.035 to -0.011, p <0.001) and MB (RD 0.011, 95% CI 0.005 to 0.017, p <0.001). In conclusion, addition of AC to the current SOC therapy can mitigate future MACE events in patients with PAD albeit at risk of increased bleeding. LD AC is associated with an efficacy/safety net benefit compared to FD AC therapy.

Hemoglobin A1c and Cardiovascular Outcomes Following Percutaneous Coronary Intervention: Insights From a Large Single-Center Registry.

OBJECTIVES: The aim of this study was to evaluate post-percutaneous coronary intervention (PCI) outcomes in relation to pre-procedural glycated hemoglobin (HbA1c) levels from a large, contemporary cohort. BACKGROUND: There are limited data evaluating associations between HbA1c, a marker of glycemic control, and ischemic risk following PCI. METHODS: All patients with known HbA1c levels undergoing PCI at a single institution between 2009 and 2017 were included. Patients were divided into 5 groups on the basis of HbA1c level: ≤5.5%, 5.6% to 6.0%, 6.1% to 7.0%, 7.1% to 8.0%, and >8.0%. The primary endpoint was major adverse cardiac events (MACE), a composite of all-cause death or myocardial infarction (MI), at 1-year follow-up. RESULTS: A total of 13,543 patients were included (HbA1c ≤5.5%, n = 1,214; HbA1c 5.6% to 6.0%, n = 2,202; HbA1c 6.1% to 7.0%, n = 4,130; HbA1c 7.1% to 8.0%, n = 2,609; HbA1c >8.0%, n = 3,388). Patients with both low (HbA1c ≤5.5%) and high (HbA1c >8.0%) levels displayed an increased risk for MACE compared with those with values between 6.1% and 7.0%. Excess risk was driven primarily by higher rates of all-cause death among those with low HbA1c levels, while higher values were strongly associated with greater MI risk. Patterns of risk were unchanged among patients with serial HbA1c levels and persisted after multivariate adjustment. CONCLUSIONS: Among patients undergoing PCI, pre-procedural HbA1c levels display a U-shaped association with 1-year MACE risk, a pattern that reflects greater risk for death in the presence of low HbA1c (≤5.5%) and higher risk for MI with higher values (>8.0%).

Clinical Characteristics and In-Hospital Mortality for COVID-19 Across The Globe.

INTRODUCTION: Numerous case series have reported on the baseline characteristics and in-hospital mortality of patients with COVID-19, however, these studies included patients localized in a specific geographic region. The purpose of our study was to identify differences in the clinical characteristics and the in-hospital mortality of patients with a laboratory-confirmed diagnosis of COVID-19 internationally. METHODS: A comprehensive search of all published literature on adult patients with laboratory-confirmed diagnosis of COVID-19 that reported on the clinical characteristics and in-hospital mortality was performed. Groups were compared using a Chi-square test with Yates correction of continuity. A two-tailed p value of less than 0.05 was considered as statistically significant. RESULTS: After screening 516 studies across the globe, 43 studies from 12 countries were included in our final analysis. Patients with COVID-19 in America and Europe were older compared to their Asian counterparts. Europe had the highest percentage of male patients. American and European patients had a higher incidence of co-morbid conditions (p < 0.05 for all variables). In-hospital mortality was significantly higher in America (22.23%) and Europe (22.9%) compared to Asia (12.65%) (p < 0.0001), but no difference was seen when compared with each other (p = 0.49). CONCLUSIONS: There is a significant variation in the clinical characteristics in patients diagnosed with COVID-19 across the globe. In-hospital mortality is similar between America and Europe, but considerably higher than Asia.

Rotational Atherectomy Induced Coronary Perforation of Right Coronary Artery Draining into Middle Cardiac Vein.

Ellis Type III cavity spilling coronary perforation is a rare complication. We report to our knowledge, the first case of rotational atherectomy induced Type III cavity spilling coronary perforation of right posterior descending artery draining into middle cardiac vein, successfully managed by covered stent deployment. (Level of Difficulty: Advanced.).

Subclinical involvement of common carotid arteries in patients with fibromuscular dysplasia - a case-control study.

Background: Fibromuscular dysplasia (FMD) primarily involves medium-sized arteries, though the entire spectrum of vascular involvement is not fully understood. We hypothesized that larger arteries may also be affected, albeit sub-clinically. Patients and methods: We measured the cross-sectional diameter of the thoracic aorta, abdominal aorta, common iliac arteries (CIA) and common carotid arteries (CCA) in FMD subjects and compared them to matched controls. We retrospectively analyzed records of FMD subjects (n = 74) and of age- and sex- matched controls (n = 74) that underwent computed tomography of the neck, chest or abdomen. Cross-sectional diameters of the thoracic and abdominal aorta, CIA and CCA were measured in a standardized manner by two trained physicians. Results: The FMD group had a significantly greater diameter of the CIA and CCA bilaterally. The measurements (mm) in FMD and control groups were as follows: Right CIA: 10.85 + 1.75 vs. 10.23 + 1.36, p = 0.04, left CIA: 11.01 + 1.93 vs. 10.15 + 1.38, p = 0.007, right CCA: 7.70 + 0.81 vs. 6.80 + 1.10, p < 0.001 and left CCA: 7.70 + 1.10 vs. 6.80 + 1.0, p < 0.001). There was no difference in the diameter between the two groups in the ascending aorta, descending and the abdominal aorta. After adjusting for baseline differences, common carotid arteries (but not common iliac) were significantly larger in FMD group compared with controls. Conclusions: There is sub-clinical involvement of the common carotid arteries in patients with FMD and this manifests as a greater diameter of these arteries compared to age and sex matched controls.

Acute kidney injury in patients undergoing endovascular therapy for critical limb ischemia.

BACKGROUND: Similar to coronary angiography and interventions, patients undergoing percutaneous treatment of lower extremity peripheral arterial disease are also at risk of acute kidney injury (AKI). The incidence, risk factors associations, need for dialysis and inhospital mortality related to AKI in patients with critical limb ischemia (CLI) following endovascular therapy is poorly defined. OBJECTIVES: The purpose of this study was to analyze data from the National Inpatient Sample (NIS) to determine the aforementioned outcomes in patients with CLI. METHODS: Using the full NIS admission dataset from 2003 through 2012, ICD-9 codes relevant to comorbid conditions, procedure codes, composite codes for AKI, and inhospital mortality were analyzed using multivariate models. RESULTS: A total of 273,624 patients were included with a mean age of 70.0 ± 27.4 years, 46.0% were female, 57.2% had diabetes, 43.4% had coronary artery disease (CAD), and 29.2% had chronic kidney disease (CKD). The overall rate of AKI was 10.4%, and there was a temporal rise over the analysis period in AKI incidence (p < .001). Age, diabetes, CKD, and heart failure were all associated with AKI (p < .0001). The inhospital mortality rate in the patients with AKI declined over time but was higher than in patients without AKI (6.0% vs. 1.4%), p < .0001. The mortality rate was substantially higher in patients with AKI requiring dialysis as compared to AKI not requiring dialysis (13.4% vs. 5.6%), p < .0001. CONCLUSIONS: AKI is associated with age, CKD, and heart failure. The incidence of AKI following endovascular therapy for CLI is rising and independently associated with inhospital mortality.

Relation of Testosterone Normalization to Mortality and Myocardial Infarction in Men With Previous Myocardial Infarction.

The effect of normalization of serum testosterone levels with testosterone replacement therapy (TRT) in patients with a history of myocardial infarction (MI) is unknown. The objective of this study was to determine the incidence of recurrent MI and all-cause mortality in subjects with a history of MI and low total testosterone (TT) with and without TRT. We retrospectively examined 1,470 men with documented low TT levels and previous MI, categorized into Gp1: TRT with normalization of TT levels (n = 755) Gp2: TRT without normalization of TT levels (n = 542), and Gp3: no TRT (n = 173). The association of TRT with all-cause mortality and recurrent MI was compared using propensity score-weighted Cox proportional hazard models. All-cause mortality was lower in Gp1 versus Gp2 (hazard ratio [HR] 0.76, confidence interval [CI] 0.64 to 0.90, p = 0.002), and Gp1 versus Gp3 (HR 0.76, CI 0.60 to 0.98, p = 0.031). There was no significant difference in the risk of death between Gp2 versus Gp3 (HR 0.97, CI 0.76 to 1.24, p = 0.81). Adjusted regression analyses showed no significant differences in the risk of recurrent MI between groups (Gp1 vs Gp3, HR 0.79, CI 0.12 to 5.27, p = 0.8; Gp1 vs Gp2 HR 1.10, CI 0.25 to 4.77, p = 0.90; Gp2 vs Gp3 HR 0.58, CI 0.08 to 4.06, p = 0.58). In conclusion, in a large observational cohort of male veterans with previous MI, normalization of TT levels with TRT was associated with decreased all-cause mortality compared with those with non-normalized TT levels and the untreated group. Furthermore, in this high-risk population, TRT was not associated with an increased risk of recurrent MI.

National Trends, Gender, Management, and Outcomes of Patients Hospitalized for Myocarditis.

Myocarditis is a major cause of acute and chronic cardiomyopathy. Data on patient characteristics utilization of healthcare, and outcomes of myocarditis-related hospitalizations are limited. We sought to analyze the outcomes of patients hospitalized with myocarditis from a large diverse, multicentric, nationwide cohort using Nationwide Inpatient Sample database. A total of 27,129 hospitalizations involving adult patients (age ≥ 18 years) with the primary discharge diagnosis of myocarditis from years 2007 through 2014 were included and patients who had diagnosis of myocardial infarction or coronary syndromes (including unstable angina) during the same hospitalization were excluded. More men were hospitalized compared with women (66% vs 34%, p <0.05). Patients hospitalized were young with a mean age of 37.3 ± 18.8 years with women being older compared with men (45.2 ± 20.9 vs 33.2 ± 16.2, p <0.001). In-hospital complications of cardiogenic shock and ventricular fibrillation/cardiac arrest occurred in 6.5% and 2.5% of hospitalizations, respectively, with females being affected significantly more than males (10.2% vs 4.6%; 3.6% vs 2%, respectively, p <0.001 for both comparisons). A total of 640 (2.4%) patients died during index hospitalization. Mortality was significantly higher in females compared with males (3.5% vs 1.8%; p <0.001). Multiple logistic regression analysis demonstrated female gender as an independent predictor of in-hospital mortality (odds ratio: 1.69, 95% confidence interval: 1.1 to 2.6; p = 0.007). In conclusion, myocarditis-related hospitalizations have increased during the study years and mostly affect young population with no significant co-morbidities. Female gender remains at high risk for myocarditis-related complications and in-hospital mortality.

Congenital Renal Arteriovenous Malformation: A Rare but Treatable Cause of Hypertension.

BACKGROUND Congenital renal vascular anomalies have been classified into 3 categories: cirsoid, angiomatous, and aneurysmal. These classifications are based on the size, location, and number of vessels involved. Aneurysmal malformations, such as the one reported here, have a single (and dilated) feeding and draining vessel. The prevalence of renal AVMs is estimated at less than 0.04%, making them rare causes of secondary hypertension. CASE REPORT A 29-year-old white woman was seen in the hypertension clinic as a referral from high-risk obstetric clinic for management of hypertension (HTN). A secondary hypertension workup with Doppler waveforms of the renal arteries revealed prominent diastolic flow in the left compared to the right. For confirmation, an MRA was done, which showed a large left renal upper-pole arteriovenous malformation (AVM) with associated vascular shunting and early opacification of the left renal vein. This congenital AVM was identified as the cause of her hypertension. Angiography and coil embolization were performed. The patient's BP normalized within a few days and she was taken off her antihypertensive medications. CONCLUSIONS This case illustrates that a careful review of duplex waveforms beyond just peak velocity and ratios is important to identify uncommon pathologies. This is important, as renal AVMs respond well to embolization, with resolution of hypertension in 59% of patients treated.

Guidewire fracture during orbital atherectomy for peripheral artery disease: Insights from the Manufacturer and User Facility Device Experience database.

BACKGROUND/OBJECTIVES: Orbital atherectomy (OA) is routinely being used for plaque modification to facilitate percutaneous revascularization in patients with peripheral arterial disease (PAD) and arterial calcification. Guidewire fracture (GWF) during OA, though anecdotally described, has not been studied in a systematic manner. We conducted a review of the Manufacturer and User Facility Device Experience (MAUDE) database to study the reports of wire fracture and its management and consequences. METHODS: We queried the MAUDE database for all events involving the current generation of the OA device: "Diamondback 360 Peripheral Orbital Atherectomy System", and "Stealth 360° Orbital PAD System". RESULTS: We identified 62 reports of GWF during OA for PAD. The superficial femoral artery was the most commonly involved atherectomy site. The wire fractured at the soft tip in a majority of cases (68%). Embolized wire fragments were left in the patient in 36 cases (58%), retrieved percutaneously in 10 cases (16%), and trapped by a stent against the arterial wall in eight cases (13%). Lastly, eight patients (13%) underwent surgery for removal of the wire fragment. CONCLUSIONS: This is the first published report to study the complication of GWF during peripheral OA. GWF is an uncommon but has significant procedural and clinical consequences. It results in a high rate of ancillary rescue procedures (including surgery) and is associated with a higher risk of arterial thrombosis and complications from wire retrieval attempts. The risk of wire fracture may be avoided with carefully adherence to the IFU.

A novel unembalmed human cadaveric limb model for assessing conformational changes in self-expanding nitinol stents in the popliteal artery.

OBJECTIVE: To develop an unembalmed human cadaveric lower limb model as a more realistic environment for testing self-expanding nitinol stents. We studied conformational changes and strain induced by knee flexion in nitinol stents deployed in the popliteal artery (PA). METHODS: One Lifestent® each was deployed into one limb of four cadavers (control group), while the contralateral leg received a different stent (Absolute®, Protégé Everflex®, Supera®, and Gore Viabahn®). The limbs were mounted on a quasi-static knee rig (QKR) and X-ray imaging was performed at pre-defined knee flexion angles. A least-squares solution to the equation of a circle was used to assess radius of curvature at flexion points (FP), and nominal strain was calculated for each stented artery. RESULTS: There were differences but also some similarities in conformational changes seen in the various stents. Knee flexion produced at least two FP in all stents. The mean radius of curvature decreased with increasing degrees of flexion but more so in distal (main) than proximal (accessory) FP (22 mm vs. 11 mm) in all stents. Supera® stent had the greatest relative radii of curvatures, and Absolute® stent had the highest strain value in comparison to the contralateral PA as the control group. CONCLUSION: This study describes a novel human cadaveric limb model for testing self-expanding nitinol stents implanted in the PA. Several parameters of conformational change in the stented PA such as FP formation, FP translocation and strain induced by axial compression were described. These may be useful for developing new stents for the PA location.

National Trends and Procedural Complications from Endomyocardial Biopsy: Results from the National Inpatient Sample, 2007-2014.

AIM: The aim of this study is to report recent trends in the performance of endomyocardial biopsy (EMB) and its in-hospital complications (and their predictors) in the United States (US). METHOD: We analyzed Nationwide Inpatient Sample (NIS) database from years 2007 through 2014 to identify patients who underwent EMB. Once identified, the patients were subdivided into those with no history of heart transplant (HT) (cohort 1) and those with history of HT (cohort 2). We then studied the major complication of pericardial effusion, hemopericardium or/and cardiac tamponade that required a pericardiocentesis or a pericardial window (CTRPD) following the EMB procedure. RESULTS: We observed a steady increase in the in-patient EMB procedures, with more EMB procedures being performed in males and in Caucasians. In cohort 1, the CTRPD was higher (0.70%) as compared to cohort 2 (0.19; p = 0.01). CTRPD in women was higher compared to men (0.94 vs. 0.53% p = 0.022). Most of the EMB procedures are performed in teaching hospitals. The CTRPD rate was significantly higher in the nonteaching hospitals when compared to teaching hospitals in both cohort 1 and cohort 2 (3.4 vs. 0.53% and 1 vs.0.18%, respectively; p = 0.01 and < 0.001, respectively). The overall mortality in cohort 1 was 4.3% as compared to 2.5% in cohort 2; p = 0.01. In cohort 1, the mortality was significantly higher in the group that had EMB-related complications versus the group without the complications (20 vs. 2.5%; p < 0.001). CONCLUSION: There has been an increase in the number of EMB procedures in the US in recent years. Though the overall risk of CTRPD is very low, the risk is significantly higher in cohort 1, women, and in nonteaching hospitals. The study results provide data benchmarks for assessing EMB outcomes in the US.