IMPROvE-CED Trial: Intracoronary Autologous CD34+ Cell Therapy for Treatment of Coronary Endothelial Dysfunction in Patients With Angina and Nonobstructive Coronary Arteries.

BACKGROUND: Coronary endothelial dysfunction (CED) causes angina/ischemia in patients with nonobstructive coronary artery disease (NOCAD). Patients with CED have decreased number and function of CD34+ cells involved in normal vascular repair with microcirculatory regenerative potential and paracrine anti-inflammatory effects. We evaluated safety and potential efficacy of intracoronary autologous CD34+ cell therapy for CED. METHODS: Twenty NOCAD patients with invasively diagnosed CED and persistent angina despite maximally tolerated medical therapy underwent baseline exercise stress test, GCSF (granulocyte colony stimulating factor)-mediated CD34+ cell mobilization, leukapheresis, and selective 1×105 CD34+ cells/kg infusion into left anterior descending. Invasive CED evaluation and exercise stress test were repeated 6 months after cell infusion. Primary end points were safety and effect of intracoronary autologous CD34+ cell therapy on CED at 6 months of follow-up. Secondary end points were change in Canadian Cardiovascular Society angina class, as-needed sublingual nitroglycerin use/day, Seattle Angina Questionnaire scores, and exercise time at 6 months. Change in CED was compared with that of 51 historic control NOCAD patients treated with maximally tolerated medical therapy alone. RESULTS: Mean age was 52±13 years; 75% were women. No death, myocardial infarction, or stroke occurred. Intracoronary CD34+ cell infusion improved microvascular CED (%acetylcholine-mediated coronary blood flow increased from 7.2 [-18.0 to 32.4] to 57.6 [16.3-98.3]%; P=0.014), decreased Canadian Cardiovascular Society angina class (3.7±0.5 to 1.7±0.9, Wilcoxon signed-rank test, P=0.00018), and sublingual nitroglycerin use/day (1 [0.4-3.5] to 0 [0-1], Wilcoxon signed-rank test, P=0.00047), and improved all Seattle Angina Questionnaire scores with no significant change in exercise time at 6 months of follow-up. Historic control patients had no significant change in CED. CONCLUSIONS: A single intracoronary autologous CD34+ cell infusion was safe and may potentially be an effective disease-modifying therapy for microvascular CED in humans. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03471611.

Rapid Exclusion of Acute Myocardial Injury and Infarction With a Single High-Sensitivity Cardiac Troponin T in the Emergency Department: A Multicenter United States Evaluation.

BACKGROUND: There are good data to support using a single high-sensitivity cardiac troponin T (hs-cTnT) below the limit of detection of 5 ng/L to exclude acute myocardial infarction. Per the US Food and Drug Administration, hs-cTnT can only report to the limit of quantitation of 6 ng/L, a threshold for which there are limited data. Our goal was to determine whether a single hs-cTnT below the limit of quantitation of 6 ng/L is a safe strategy to identify patients at low risk for acute myocardial injury and infarction. METHODS: The efficacy (proportion identified as low risk based on baseline hs-cTnT<6 ng/L) of identifying low-risk patients was examined in a multicenter (n=22 sites) US cohort study of emergency department patients undergoing at least 1 hs-cTnT (CV Data Mart Biomarker cohort). We then determined the performance of a single hs-cTnT<6 ng/L (biomarker alone) to exclude acute myocardial injury (subsequent hs-cTnT >99th percentile in those with an initial hs-cTnT<6 ng/L). The clinically intended rule-out strategy combining a nonischemic ECG with a baseline hs-cTnT<6 ng/L was subsequently tested in an adjudicated cohort in which the diagnostic performance for ruling out acute myocardial infarction and safety (myocardial infarction or death at 30 days) were evaluated. RESULTS: A total of 85 610 patients were evaluated in the CV Data Mart Biomarker cohort, among which 24 646 (29%) had a baseline hs-cTnT<6 ng/L. Women were more likely than men to have hs-cTnT<6 ng/L (38% versus 20%, P<0.0001). Among 11 962 patients with baseline hs-cTnT<6 ng/L and serial measurements, only 1.2% developed acute myocardial injury, resulting in a negative predictive value of 98.8% (95% CI, 98.6-99.0) and sensitivity of 99.6% (95% CI, 99.5-99.6). In the adjudicated cohort, a nonischemic ECG with hs-cTnT<6 ng/L identified 33% of patients (610/1849) as low risk and resulted in a negative predictive value and sensitivity of 100% and a 30-day rate of 0.2% for myocardial infarction or death. CONCLUSIONS: A single hs-cTnT below the limit of quantitation of 6 ng/L is a safe and rapid method to identify a substantial number of patients at very low risk for acute myocardial injury and infarction.

Obesity and vascular complication in percutaneous transfemoral transcatheter aortic valve insertion.

BACKGROUND: Obesity has been associated with an increased risk of vascular complication during percutaneous coronary intervention, but there are no data on the risk of vascular complication during percutaneous transfemoral transcatheter aortic valve insertion (TAVI). OBJECTIVES: We hypothesized there would be a similar increased risk associated with TAVI. METHODS: We reviewed the records of 1176 patients who received percutaneous transfemoral transcatheter aortic valve insertion from September 2015 to September 2020. All patients received 1) preoperative computed tomoraphy angiography assessment of the abdomen and pelvis to delineate iliofemoral artery anatomy, 2) ultrasound-guided percutaneous femoral arterial access, and 3) pre-closure of the delivery sheath femoral access site. Vascular complication was recorded based on definitions set forth by Valve Academic Research Consortium 3. RESULTS: The median age of patients was 81 years, and 60% were men. The median body mass index (BMI) was 29 kg/m2 (range, 11-67), and 91 (8%) patients had a value ≥40 kg/m2 (i.e., morbid obesity). Delivery sheath size was 14-French in 859 (73%) patients, 16-French in 311 (26%), and 18-French in 6 (1%). Vascular complication occurred in 53 (5%) patients, including 39 (7%) among the first half of procedures and 14 (2%) among the second half (p < 0.001). When stratified by obesity status (BMI < or ≥30 kg/m2 , p < 0.001), the complication rate was 4% in nonobese patients and 5% in obese patients. Multivariable analysis showed no overall association between risk of vascular complication and BMI categories (p = 0.583)BMI continuous values (p = 0.529), or sheath size (p = 0.217). CONCLUSIONS: Obesity is not associated with a vascular complication during percutaneous transfemoral transcatheter aortic valve insertion. The operation should not be denied in obese patients.

Treatment Effect of Percutaneous Coronary Intervention in Dialysis Patients With ST-Elevation Myocardial Infarction.

RATIONALE & OBJECTIVE: Patients receiving maintenance dialysis have higher mortality after primary percutaneous coronary intervention (pPCI) than patients not receiving dialysis. Whether pPCI confers a benefit to patients receiving dialysis that is similar to that which occurs in lower-risk groups remains unknown. We compared the effect of pPCI on in-hospital outcomes among patients hospitalized for ST-elevation myocardial infarction (STEMI) and receiving maintenance dialysis with the effect among patients hospitalized for STEMI but not receiving dialysis. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: We used the National Inpatient Sample (2016-2018) and included all adult hospitalizations with a primary diagnosis of STEMI. PREDICTORS: Primary exposure was PCI. Confounders included dialysis status, demographics, insurance, household income, comorbidities, and the elective nature of the admission. OUTCOME: In-hospital mortality, stroke, acute kidney injury, new dialysis requirement, vascular complications, gastrointestinal bleeding, blood transfusion, mechanical ventilation, palliative care, and discharge destination. ANALYTICAL APPROACH: The average treatment effect (ATE) of pPCI was estimated using propensity score matching independently within the group receiving dialysis and the group not receiving dialysis to explore whether the effect is modified by dialysis status. Additionally, the average marginal effect (AME) was calculated accounting for the clustering within hospitals. RESULTS: Among hospitalizations, 4,220 (1.07%) out of 413,500 were for patients receiving dialysis. The dialysis cohort was older (65.2 ± 12.2 vs 63.4 ± 13.1, P < 0.001), had a higher proportion of women (42.4% vs 30.6%, P < 0.001) and more comorbidities, and had a lower proportion of White patients (41.1% vs 71.7%, P < 0.001). Patients receiving dialysis were less likely to undergo angiography (73.1% vs 85.4%, P < 0.001) or pPCI (57.5% vs 79.8%, P < 0.001). Primary PCI was associated with lower mortality in patients receiving dialysis (15.7% vs 27.1%, P < 0.001) as well as in those who were not (5.0% vs 17.4%, P < 0.001). The ATE on mortality did not differ significantly (P interaction = 0.9) between patients receiving dialysis (-8.6% [95% CI, -15.6% to -1.6%], P = 0.02) and those who were not (-8.2% [95% CI, -8.8% to -7.5%], P < 0.001). The AME method showed similar results among patients receiving dialysis (-9.4% [95% CI, -14.8% to -4.0%], P < 0.001) and those who were not (-7.9% [95% CI, -8.5% to -7.4%], P < 0.001) (P interaction = 0.6). Both the ATE and AME were comparable for other in-hospital outcomes in both groups. LIMITATIONS: Administrative data, lack of pharmacotherapy and long-term outcome data, and residual confounding. CONCLUSIONS: Compared with conservative management, pPCI for STEMI was associated with comparable reductions in short-term mortality among patients irrespective of their receipt of maintenance dialysis.

Contemporary Techniques for Femoral and Radial Arterial Access in the Cardiac Catheterization Laboratory.

Safe and efficient arterial access is critical for optimal patient outcomes and procedural success in the cardiac catheterization laboratory. Because of the lower risk for vascular and bleeding complications, as well as patient comfort, transradial access has become the predominant approach for diagnostic coronary angiography and percutaneous coronary intervention. Transfemoral access, however, is still required for selected complex percutaneous coronary interventions, mechanical circulatory support, and structural heart procedures. The use of adjunctive technology and techniques such as ultrasound guidance and micropuncture can be combined with fluoroscopy and palpation to improve outcomes associated with vascular access. The importance of optimal access techniques has augmented due to increasing volume of structural heart and mechanical circulatory support procedures requiring large bore sheaths. In this document we review the contemporary techniques for femoral and radial access in the cardiac catheterization laboratory.

Effect of eliminating pre-discharge transthoracic echocardiogram on outcomes after TAVR.

OBJECTIVES: The aim of this study was to determine the safety of eliminating the pre-discharge transthoracic echocardiogram (TTE) on 30-day outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: TTE is utilized before, during, and after TAVR. Post-procedural, pre-discharge TTE assists in assessment of prosthesis function and detection of clinically significant paravalvular leak (PVL) after TAVR. METHODS: Patients who underwent TAVR at Mayo Clinic from July 2018 to July 2019 were included in a prospective institutional registry. Patients undergoing TAVR prior to February 2019 received a pre-discharge TTE, while those undergoing TAVR after February 2019 did not. Both cohorts were evaluated with TTE at 30 days post-TAVR. RESULTS: A total of 330 consecutive patients were included. Of these, 160 patients (age 81.1 ± 7.6) had routine pre-discharge TTE, while 170 patients (age 78.9 ± 7.5) were dismissed without routine pre-discharge TTE. Mortality at 30 days was similar between the two groups (0% and 1.2%, respectively). One episode of PVL requiring intervention (0.6%) occurred in the pre-discharge TTE group and none in the group without pre-discharge TTE at 30-day follow-up. There was a similar incidence of total composite primary and secondary adverse events between the cohort receiving a pre-discharge TTE and those without (28.1% vs. 25.3%, P = 0.56) at 30 days. The most common event was need for permanent pacemaker or ICD implantation in both groups (13.1% vs. 11.8%, P = 0.71). CONCLUSIONS: Elimination of the pre-discharge TTE is safe and associated with comparable 30-day outcomes to routine pre-discharge TTE. These findings have implication for TAVR practice cost-efficiency and health care utilization.

Incidence, Trends, and Outcomes of Type 2 Myocardial Infarction in a Community Cohort.

BACKGROUND: Type 2 myocardial infarction (T2MI) occurs because of an acute imbalance in myocardial oxygen supply and demand in the absence of atherothrombosis. Despite being frequently encountered in clinical practice, the population-based incidence and trends remain unknown, and the long-term outcomes are incompletely characterized. METHODS: We prospectively recruited residents of Olmsted County, Minnesota, who experienced an event associated with a cardiac troponin T >99th percentile of a normal reference population (≥0.01 ng/mL) between January 1, 2003, and December 31, 2012. Events were retrospectively classified into type 1 myocardial infarction (T1MI, atherothombotic event), T2MI, or myocardial injury (troponin rise not meeting criteria for myocardial infarction [MI]) using the universal definition. Outcomes were long-term all-cause and cardiovascular mortality and recurrent MI. T2MI was further subclassified by the inciting event for supply/demand mismatch. RESULTS: A total of 5460 patients had at least one cardiac troponin T ≥0.01 ng/mL; 1365 of these patients were classified as index T1MI (age, 68.5±14.8 years; 63% male) and 1054 were classified as T2MI (age, 73.7±15.8 years; 46% male). The annual incidence of T1MI decreased markedly from 202 to 84 per 100 000 persons between 2003 and 2012 (P<0.001), whereas the incidence of T2MI declined from 130 to 78 per 100 000 persons (P=0.02). In comparison with patients with T1MI, patients with T2MI had higher long-term all-cause mortality after adjustment for age and sex, driven by early and noncardiovascular death. Rates of cardiovascular death were similar after either type of MI (hazard ratio, 0.8 [95% CI, 0.7-1.0], P=0.11). Subclassification of T2MI by cause demonstrated a more favorable prognosis when the principal provoking mechanism was arrhythmia, in comparison with postoperative status, hypotension, anemia, and hypoxia. After index T2MI, the most common MI during follow-up was a recurrent T2MI, whereas the occurrence of a new T1MI was relatively rare (estimated rates at 5 years, 9.7% and 1.7%). CONCLUSIONS: There has been an evolution in the type of MI occurring in the community over a decade, with the incidence of T2MI now being similar to T1MI. Mortality after T2MI is higher and driven by early and noncardiovascular death. The provoking mechanism of supply/demand mismatch affects long-term survival. These findings underscore the healthcare burden of T2MI and provide benchmarks for clinical trial design.

High-Sensitivity Cardiac Troponin T for the Detection of Myocardial Injury and Risk Stratification in COVID-19.

BACKGROUND: Limited data exist on high-sensitivity cardiac troponin (hs-cTn) for risk-stratification in COVID-19. METHODS: We conducted a multicenter, retrospective, observational, US-based study of COVID-19 patients undergoing hs-cTnT. Outcomes included short-term mortality (in-hospital and 30-days post-discharge) and a composite of major adverse events, including respiratory failure requiring mechanical ventilation, cardiac arrest, and shock within the index presentation and/or mortality during the index hospitalization or within 30-days post-discharge. RESULTS: Among 367 COVID-19 patients undergoing hs-cTnT, myocardial injury was identified in 46%. They had a higher risk for mortality (20% vs 12%, P < 0.0001; unadjusted HR 4.44, 95% CI 2.13-9.25, P < 0.001) and major adverse events (35% vs. 11%, P < 0.0001; unadjusted OR 4.29, 95% CI 2.50-7.40, P < 0.0001). Myocardial injury was associated with major adverse events (adjusted OR 3.84, 95% CI 2.00-7.36, P < 0.0001) but not mortality. Baseline (adjusted OR 1.003, 95% CI 1.00-1.007, P = 0.047) and maximum (adjusted OR 1.005, 95% CI 1.001-1.009, P = 0.0012) hs-cTnT were independent predictors of major adverse events. Most (95%) increases were due to myocardial injury, with 5% (n = 8) classified as type 1 or 2 myocardial infarction. A single hs-cTnT <6 ng/L identified 26% of patients without mortality, with a 94.9% (95% CI 87.5-98.6) negative predictive value and 93.1% sensitivity (95% CI 83.3-98.1) for major adverse events in those presenting to the ED. CONCLUSIONS: Myocardial injury is frequent and prognostic in COVID-19. While most hs-cTnT increases are modest and due to myocardial injury, they have important prognostic implications. A single hs-cTnT <6 ng/L at presentation may facilitate the identification of patients with a favorable prognosis.

Endovascular snare technique to facilitate delivery of self-expanding valve during transcatheter aortic valve-in-valve replacement in angulated aortas: A case series.

BACKGROUND: Transcatheter aortic valve-in-valve replacement (ViV) has been widely accepted as a less invasive alternative to treat failed aortic surgical or transcatheter bioprosthetic valves. Angulated aortas present an additional challenge, particularly when using self-expanding transcatheter heart valves (SE-THV). METHODS: Two patients with failed surgical bioprosthetic aortic valves and one patient with a failed transcatheter bioprosthetic aortic valve underwent transcatheter aortic ViV using SE-THV. All were deemed high-risk for surgical aortic valve replacement by a heart team. All three patients had initial failed SE-THV delivery using a conventional approach with subsequent successful delivery using the endovascular snare technique. RESULTS: In Cases 1 and 2, the SE-THV was biased towards the greater curve of the angulated aorta and behind the outer frame of the bioprosthetic valve frame. An endovascular snare was deployed through a secondary left femoral artery access, and the valve delivery system was advanced through the snare in the ascending aorta. The snare was tightened around the SE-THV capsule proximal to the hat-marker, allowing deflection of the SE-THV and successful delivery. In Case 3, the SE-THV interacted with the tall frame of a failed SE-THV. A snare via the left femoral artery was deployed in the descending artery. The SE-THV was advanced through the snare, and both the snare and SE-THV were advanced together to the ascending aorta where the SE-THV was deflected and successfully delivered. CONCLUSIONS: The endovascular snare technique is a feasible option for successful delivery of SE-THV during transcatheter aortic ViV in failed transcatheter or surgical bioprosthetic valves in angulated aortas.

Remote robotic percutaneous coronary intervention: An animal feasibility study.

OBJECTIVES: The purpose of this study was to explore the feasibility and safety of robotic PCI performed using an off-siteremote-control system in an animal model. BACKGROUND: Access to primary percutaneous coronary intervention (PCI) remains a challenge in acute myocardial infarction management. The combination of telemedicine and robotic PCI allow the potential delivery of primary PCI to remote locations without the delay of transfer. METHODS: This single-center prospective pilot preclinical feasibility study compared robotic PCI with remote PCI on swine across three stages (adjacent room, different floor of the same building, two different buildings). Latency up to 1,000 ms was introduced into the operating environment to simulate decreased network quality (blinded to operator). The primary outcome measures were technical success and acute safety. The secondary outcome measures included lesion wiring time, procedural time and qualitative scoring of the PCI experience by the operator. RESULTS: Across 52 experiments in 15 animals, technical success was 100%. No procedural complications occurred during the study. No significant difference in lesion treatment time was detected between stages (p = .11) and between time per target vessel when latency up to 1,000 ms was introduced (p = .58). Injected delay >250 ms had the greatest impact on procedure perceived lag. Longer procedure time was associated with lower procedure impact score, regardless of injected latency. CONCLUSIONS: Remote robotic PCI was feasible and safe in an animal model. Procedural duration was acceptable and unaffected by network latency. Future studies are needed to determine the safety and feasibility of remote PCI in humans.

Association Between Antifibrinolytic Therapy and Perioperative Outcomes in Patients With Coronary Artery Stents Undergoing Noncardiac Surgery.

BACKGROUND: Patients with existing coronary artery stents are at an increased risk for major adverse cardiac events (MACEs) when undergoing noncardiac surgery (NCS). Although the use of antifibrinolytic (AF) therapy in NCS has significantly increased in the past decade, the relationship between perioperative AF use and its association with MACEs among patients with existing coronary artery stents has yet to be assessed. In this study, we aim to evaluate the association of MACEs in patients with existing coronary artery stents who receive perioperative AF therapy during orthopedic surgery. METHODS: A single-center retrospective cohort study was conducted in adult patients with existing coronary artery stents who underwent orthopedic surgery from 2008 to 2018. Two cohorts were established: patients with existing coronary artery stents who did not receive perioperative AF and patients with coronary artery stents who received perioperative AF. Associations between AF use and the primary outcome of MACEs within 30 days postoperatively and the secondary outcomes of thrombotic complications, excessive surgical bleeding, and intensive care unit (ICU) admissions were analyzed using logistic regression models. Inverse probability of treatment weighting was used to control for confounding. Secondary analyses examining the association between coronary stent type/timing and the outcomes of interest were performed using unadjusted logistic regression models. RESULTS: A total of 473 patients met study criteria, including 294 who did not receive AF and 179 patients who received AF. MACEs occurred in 15 (5.1%) patients who did not receive AF and 1 (0.6%) who received AF (P = .007). In weighted analyses, no significant difference was found in patients who received AF with regard to MACEs (odds ratio [OR] = 0.13, 95% confidence interval [CI], 0.01-1.74, P = .12), thrombotic complications (OR = 1.19, 95% CI, 0.53-2.68, P = .68), or excessive surgical bleeding (OR = 0.13, 95% CI, 0.01-2.23, P = .16) compared to patients who did not receive AF. CONCLUSIONS: The results of this study are inconclusive whether an association exists between perioperative AF use in patients with coronary artery stents and the outcome of MACEs compared to patients who did not receive perioperative AF therapy. The authors acknowledge that the imprecise CI hinders the ability to definitively determine whether an association exists in the study population. Further large prospective studies, powered to detect differences in MACEs, are needed to assess the safety of perioperative AF in patients with existing coronary artery stents and to clarify the mechanism of perioperative MACEs in this high-risk population.

SCAI expert consensus statement update on best practices for transradial angiography and intervention.

Transradial angiography and intervention continues to become increasingly common as an access site for coronary procedures. Since the first "Best Practices" paper in 2013, ongoing trials have shed further light onto the safest and most efficient methods to perform these procedures. Specifically, this document comments on the use of ultrasound to facilitate radial access, the role of ulnar artery access, the utility of non-invasive testing of collateral flow, strategies to prevent radial artery occlusion, radial access for primary PCI and topics that require further study.

Haptoglobin Phenotype Is Associated With High-Density Lipoprotein-Bound Hemoglobin Content and Coronary Endothelial Dysfunction in Patients With Mild Nonobstructive Coronary Artery Disease.

Objective- Coronary endothelial dysfunction (ED) is an early stage of atherosclerosis and is associated with impaired high-density lipoprotein (HDL) function. A functional polymorphism at the haptoglobin (Hp) gene locus (rs72294371) has been associated with marked differences in HDL structure and function. We sought to determine whether Hp phenotype was associated with coronary ED and whether the amount of hemoglobin (Hb) tethered to HDL via Hp was Hp-type dependent and associated with ED. Approach and Results- Microvascular and epicardial coronary endothelial function was assessed in 338 individuals with nonobstructive coronary artery disease. Microvascular ED was defined as <50% change in coronary blood flow and epicardial ED as ≥20% decrease in coronary artery diameter after intracoronary acetylcholine infusion. The amount of Hb bound to HDL was measured by ELISA after HDL purification from plasma samples using immune-affinity chromatography. One hundred and seventy of the individuals in this study (50.3%) were diagnosed with microvascular ED, 143 (42.3%) with epicardial ED, and 67 (19.7%) had diabetes mellitus (DM). Hp phenotype was significantly associated with microvascular ( P=0.01) and epicardial ED ( P=0.04) among DM individuals. There was a significant and inverse correlation between the amount of HDL-bound Hb and change in coronary blood flow (r=-0.40; P<0.0001) and in coronary artery diameter (r=-0.44; P<0.0001) in response to acetylcholine infusion. Hb content of HDL was significantly increased in individuals with Hp 2-2 and DM. In a logistic regression model, Hp 2-2 phenotype was associated with microvascular ED (odds ratio, 1.9; P=0.03) and the amount of HDL-bound Hb was an independent predictor of both microvascular (odds ratio, 4.6 for each 1-SD increase; P<0.0001) and epicardial (odds ratio, 2.2; P<0.0001) ED. Conclusions- Hp phenotype is significantly associated with coronary ED in DM individuals. This association is likely related to increased Hb tethering to HDL via Hp 2-2 in DM.

Acute Upper-Limb Complications Following Radial Artery Catheterization for Coronary Angiography.

PURPOSE: The radial artery is becoming the vessel of choice for performing cardiac catheterization. Transradial catheterization can impose risks on the upper extremity, and hand surgeons should be aware of the most frequent complications. The purpose of this study was to determine the frequency, timing, and scope of upper-limb complications shortly after transradial catheterization. METHODS: A retrospective review was conducted of the medical records of patients who underwent catheterization between 2009 and 2016. Complications were assessed for up to 60 days. The Cox model was used to assess risk factors for complications. RESULTS: A total of 10,540 patients were included in the analysis (68.5% male), median age 67 years. There were 79 patients who experienced at least one complication within 60 days (0.84% of procedures; 95% confidence interval, 0.65% to 1.02%). The most common complications were hematoma (n = 39) and radial artery occlusion (n = 28). Other complications included pseudoaneurysm (n = 7), arteriovenous fistula (n = 3), carpal tunnel syndrome (n = 4), arterial perforation (n = 3), persistent vasospasm (n = 2), and compartment syndrome (n = 1). The complications were diagnosed a median of 1 day after catheterization. Female sex was at increased risk for developing a complication. Diabetes, age, body mass index, and catheter size were not associated with an increased risk for developing a complication. Ten patients underwent surgical management of a complication. Reasons for surgery included symptomatic radial artery occlusions, pseudoaneurysm formation, arteriovenous fistulas, and compartment syndrome. No identifiable risk factors were associated with patients who underwent surgical intervention. CONCLUSIONS: The frequency of upper-limb complications after radial artery catheterization is small. They include arterial occlusion, bleeding, compartment syndrome, arteriovenous fistula, and pseudoaneurysm. Most complications presented within 1 week of the procedure and occurred more frequently in the female sex. Operative management of complications was infrequent. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.

Spontaneous Coronary Artery Dissection: Current State of the Science: A Scientific Statement From the American Heart Association.

Spontaneous coronary artery dissection (SCAD) has emerged as an important cause of acute coronary syndrome, myocardial infarction, and sudden death, particularly among young women and individuals with few conventional atherosclerotic risk factors. Patient-initiated research has spurred increased awareness of SCAD, and improved diagnostic capabilities and findings from large case series have led to changes in approaches to initial and long-term management and increasing evidence that SCAD not only is more common than previously believed but also must be evaluated and treated differently from atherosclerotic myocardial infarction. High rates of recurrent SCAD; its association with female sex, pregnancy, and physical and emotional stress triggers; and concurrent systemic arteriopathies, particularly fibromuscular dysplasia, highlight the differences in clinical characteristics of SCAD compared with atherosclerotic disease. Recent insights into the causes of, clinical course of, treatment options for, outcomes of, and associated conditions of SCAD and the many persistent knowledge gaps are presented.

Cardiac Risk of Noncardiac Surgery After Percutaneous Coronary Intervention With Second-Generation Drug-Eluting Stents.

BACKGROUND: Noncardiac surgery (NCS) following percutaneous coronary intervention (PCI) with stenting is sometimes associated with major adverse cardiac events (MACEs). Second-generation drug-eluting stents (DES) were developed to decrease the incidence of MACE seen with bare metal and first-generation DES. METHODS: The medical records of all adult patients who underwent second-generation DES placement between July 29, 2008 and July 28, 2011 followed by NCS between September 22, 2008 and July 1, 2013 were reviewed. All episodes of MACE following surgery were recorded. RESULTS: A total of 282 patients (74.8% male) were identified who underwent NCS after PCI with second-generation DES. MACE occurred in 15 patients (5.3%), including 11 deaths. The incidence of MACE changed significantly with time from PCI to NCS: 17.1%, 10.0%, 0.0%, and 3.1% for patients undergoing NCS at 0-90, 91-180, 181-365, and ≥366 days, respectively. Compared with those having NCS ≥366 days after PCI, the odds ratio for MACE (95% confidence interval) was 6.4 (1.9 to 21.3) at 0-90 days and 3.4 (0.8 to 15.3) at 91-180 days. Seven days prior to NCS, 146 (52%) patients were on dual antiplatelet therapy (DAPT), 106 (38%) were on aspirin, and 30 (11%) did not receive antiplatelet therapy. Excessive surgical bleeding occurred in 19 cases (6.7%). While observed bleeding rates were lowest in those not receiving antiplatelet therapy, there were no statistically significant differences based on the presence or absence of antiplatelet therapy (3% [1/30] for no antiplatelet therapy compared to 6% [6/106] for aspirin monotherapy and 8% [12/146] for DAPT; Fisher exact test: P = .655). CONCLUSIONS: The incidence of MACE in patients with second-generation DES undergoing NCS was 5.3% and was highest in the first 180 days following DES implantation. The rate of excessive surgical bleeding was 6.7% with the highest observed rate in those on DAPT. However, differences by the presence or absence of antiplatelet therapy were not significant, and future large observational studies will be necessary to further define bleeding risk with continued DAPT.

Characteristics and long term outcomes of patients with acute coronary syndromes due to culprit left main coronary artery disease treated with percutaneous coronary intervention.

BACKGROUND: Patients with acute coronary syndrome (ACS) due to unprotected culprit left main coronary artery disease (LMCAD) treated with percutaneous coronary intervention (PCI) are rare, high-risk, and not represented in trials. Data regarding long term outcome after PCI are limited. METHODS: Between January 2000 and December 2014, there were 8,794 patients hospitalized with unstable angina/non-ST elevation myocardial infarction (UA/NSTEMI) or ST-elevation myocardial infarction (STEMI) treated with PCI at our institution; of these, 83 (0.94%) patients were identified as having culprit LMCAD ACS. RESULTS: Of the 83 patients with unprotected LMCAD ACS, 40 patients presented with STEMI and 43 patients presented with UA/NSTEMI. As compared to LM UA/NSTEMI, LM STEMI patients were younger and had less hypertension, with a trend towards greater frequency of cardiogenic shock. Distal LM involvement was common in both groups and did not differ by ACS type. In-hospital mortality was 33% in LM STEMI and 9% in LM UA/NSTEMI (P = .009). Over median follow up of 6.3 years, long term survival rates in both groups were similar (46% for STEMI vs 51% for UA/NSTEMI; P = .50 by log-rank). CONCLUSIONS: Unprotected culprit LMCAD ACS necessitating PCI is uncommon, occurring in <1% of cases, but is associated with reduced survival, with long term follow-up noting continued and similar risk of death regardless of index ACS type.

Perforated balloon technique: A simple and handy technique to combat no-reflow phenomenon in coronary system.

OBJECTIVE: Examining the efficacy and outcomes of intracoronary (IC) instillation of adenosine using a novel perforated balloon technique (PBT) to combat no-reflow phenomenon during percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). BACKGROUND: Occurrence of no-reflow during PCI is a serious adverse prognostic event and inability to re-establish better flow is associated with poor outcomes. Several pharmacological and non-pharmacological interventions have been used to treat this situation. This series describes the use of PBT for IC adenosine administration and its effects on outcomes during real world interventional practice. METHODS: Subjects comprised of 24 patients with ACS (out of a total of 1,634 patients undergoing PCI between January 2016 and June 2017) in whom we used PBT for IC administration of adenosine to treat coronary no-reflow. RESULTS: PBT for IC adenosine instillation was used in 24 (1.5%) of 1,634 patients undergoing PCI. TIMI grade III flow was established in 21 patients (87.5%). In two patients (8.3%) TIMI grade II flow was established and in one patient (4.2%) we were unsuccessful. CONCLUSION: We demonstrate the safety and efficacy of a novel strategy for adenosine instillation in the distal coronary bed, the PBT. This technique enables rapid and cost-effective treatment of no-reflow phenomenon during PCI for ACS.

2-Dimensional Speckle Tracking Echocardiography predicts severe coronary artery disease in women with normal left ventricular function: a case-control study.

BACKGROUND: Women who have coronary artery disease (CAD) often present with atypical symptoms that may lead to misdiagnosis. We assessed strain, systolic strain rate and left ventricular dyssynchrony with 2- dimensional- speckle tracking echocardiography to evaluate its use as a non-invasive method for detecting CAD in women with normal ejection fraction compared with healthy women controls with a normal angiogram. METHODS: We included 35 women with CAD confirmed by coronary angiography and a positive exercise stress echocardiography and 35 women in a control group with a low pretest probability of CAD, normal angiogram and a normal stress echocardiography with normal EF. RESULTS: Statistically significant 2D-STE findings for the CAD vs control groups were as follows for the mean of: global circumferential strain (CS) (-19.4% vs -22.4%, P = .02); global radial S (49% vs 34%, P = .03); global radial SR (2.4 s-1 vs 1.9 s-1, P = .05); global longitudinal LV S (GLS) (-14.3% vs -17.2%, P < .001). For mechanical dyssynchrony, SD of the GLS time-to-peak (TTP) was computed (99 vs 33 ms, P < .001). The receiver operating characteristic and area under the curve (AUC) were calculated. A cutoff value of 45 ms for 1 SD of the longitudinal S TTP had 97% sensitivity and 89% specificity (AUC, 0.96). GLS cutoff value of -15.87% had 71% sensitivity and 74% specificity; AUC, 0.74 in differentiating CAD and control groups. The combined GLS, CS, and SD of the longitudinal S TTP had an AUC of 0.96 (sensitivity 97%, specificity 86%). Interclass correlations of the GLS segment and GLS TTP measurements were 0.49 (95% CI, 0.227-0.868) and 0.74 (95% CI, 0.277-0.926), respectively. CONCLUSION: In women with a normal echocardiogram and LVEF, CAD can be identified by dyssynchrony and abnormal strain values, as evidenced by 2D-STE.

Clinical outcomes of patients with hypothyroidism undergoing percutaneous coronary intervention.

AIMS: The aim of this study was to investigate the association between hypothyroidism and major adverse cardiovascular and cerebral events (MACCE) in patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: Two thousand four hundred and thirty patients who underwent PCI were included. Subjects were divided into two groups: hypothyroidism (n = 686) defined either as a history of hypothyroidism or thyroid-stimulating hormone (TSH) ≥5.0 mU/mL, and euthyroidism (n = 1744) defined as no history of hypothyroidism and/or 0.3 mU/mL ≤ TSH < 5.0 mU/mL. Patients with hypothyroidism were further categorized as untreated (n = 193), or those taking thyroid replacement therapy (TRT) with adequate replacement (0.3 mU/mL ≤ TSH < 5.0 mU/mL, n = 175) or inadequate replacement (TSH ≥ 5.0 mU/mL, n = 318). Adjusted hazard ratios (HRs) were calculated using Cox proportional hazards models. Median follow-up was 3.0 years (interquartile range, 0.5-7.0). After adjustment for covariates, the risk of MACCE and its constituent parts was higher in patients with hypothyroidism compared with those with euthyroidism (MACCE: HR: 1.28, P = 0.0001; myocardial infarction (MI): HR: 1.25, P = 0.037; heart failure: HR: 1.46, P = 0.004; revascularization: HR: 1.26, P = 0.0008; stroke: HR: 1.62, P = 0.04). Compared with untreated patients or those with inadequate replacement, adequately treated hypothyroid patients had a lower risk of MACCE (HR: 0.69, P = 0.005; HR: 0.78, P = 0.045), cardiac death (HR: 0.43, P = 0.008), MI (HR: 0.50, P = 0.0004; HR: 0.60, P = 0.02), and heart failure (HR: 0.50, P = 0.02; HR: 0.52, P = 0.017). CONCLUSION: Hypothyroidism is associated with a higher incidence of MACCE compared with euthyroidism in patients undergoing PCI. Maintaining adequate control on TRT is beneficial in preventing MACCE.