SCAI position statement on the performance of percutaneous coronary intervention in ambulatory surgical centers.

The Centers for Medicare & Medicaid Services (CMS) began reimbursement for percutaneous coronary intervention (PCI) performed in ambulatory surgical centers (ASC) in January 2020. The ability to perform PCI in an ASC has been made possible due to the outcomes data from observational studies and randomized controlled trials supporting same day discharge (SDD) after PCI. In appropriately selected patients for outpatient PCI, clinical outcomes for SDD or routine overnight observation are comparable without any difference in short-term or long-term adverse events. Furthermore, a potential for lower cost of care without a compromise in clinical outcomes exists. These studies provide the framework and justification for performing PCI in an ASC. The Society for Cardiovascular Angiography and Interventions (SCAI) supported this coverage decision provided the quality and safety standards for PCI in an ASC were equivalent to the hospital setting. The current position paper is written to provide guidance for starting a PCI program in an ASC with an emphasis on maintaining quality standards. Regulatory requirements and appropriate standards for the facility, staff and physicians are delineated. The consensus document identified appropriate patients for consideration of PCI in an ASC. The key components of an ongoing quality assurance program are defined and the ethical issues relevant to PCI in an ASC are reviewed.

A randomized controlled trial to assess operator radiation exposure from cardiac catheterization procedures using RAD BOARD® with standard pelvic shielding versus standard pelvic shielding alone.

OBJECTIVE: To study radiation exposure to the primary operator during diagnostic cardiac catheterizations using a radio-dense RAD BOARD® radial access arm board. BACKGROUND: The use of radial access for catheterization in the United States has increased from 1% in 2007 to 41% in 2018. Compared to femoral access, operator radiation exposure from radial access is similar or higher. The RAD BOARD radio-dense radial access arm board has been marketed as reducing radiation to operators by 44%. MATERIALS AND METHODS: We randomized 265 patients undergoing catheterization via right radial access to standard pelvic lead drape shielding (nonboard group) versus RAD BOARD in addition to pelvic drape (board group). Operator radiation exposure was measured using Landauer Microstar nanoDot™ badges worn by the operator. RESULTS: Board and nonboard groups were similar with respect to demographic and procedural variables. Mean operator dose per case was higher in the board group (.65mSieverts) than in the nonboard group (.56mSieverts, P < 0.0001). In sub-group analyses, radiation doses were higher in the board group compared to the nonboard group in patients across all body mass index groups (P < 0.03). In multivariate analysis, operator dose correlated with use of the RAD BOARD more closely than any other variable (P < 0.001). Post hoc analysis of the table setup with RAD BOARD revealed that use of RAD BOARD prevented placement of a shield normally inserted into the top of the standard below-table shield. CONCLUSION: RAD BOARD with the pelvic shield was associated with higher radiation exposure to the operator compared with pelvic shield alone, likely due to inability to use standard radiation shielding along with the RAD BOARD.

Unintended Delivery of Surgical Towel Fibers into a Vein Graft During Cardiac Catheterization.

Foreign body introduction during coronary stent delivery is an uncommon, yet potentially fatal, complication of coronary angiography and interventions. Inadvertent introduction of gauze fibers, starch granules and other foreign materials into circulation has been reported in literature. The introduction of inorganic surgical debris can cause distal embolization, vessel occlusion and wall infiltration causing infarction, acute stenosis and granulomatous reaction. This report describes a case of successful extraction of inorganic blue filamentous material during coronary vein graft intervention detected as a filling defect in a filter during coronary vein graft intervention. The specimen represented fibers from blue surgical towels used on sterile field during cardiac catheterization.

Percutaneous Closure of Persistent Atrial Septal Defects After Pulmonary Vein Isolation.

Pulmonary vein isolation (PVI) with radiofrequency or cryoballoon ablation to treat atrial fibrillation requires trans-septal puncture. This creates a small iatrogenic atrial septal defect (iASD). In most patients, the defect spontaneously closes after 3-6 months. However, persistent iASDs can cause hemodynamic changes and adverse consequences from inter-atrial shunting. Persistent post PVI iASDs that are clinically significant can be closed percutaneously. This diagnosis should be considered in patients with worsening dyspnea or fatigue after PVI. We present a case of post PVI iASDs causing immediate or late onset hemodynamic changes and clinical symptoms, which improved after ASD closure. We provide a review of previously reported cases and literature on post PVI ASD prevalence, risk factors and outcomes after ASD closure.

The effect of cangrelor and access site on ischaemic and bleeding events: insights from CHAMPION PHOENIX.

AIMS: To assess whether the use of the femoral or radial approach for percutaneous coronary intervention (PCI) interacted with the efficacy and safety of cangrelor, an intravenous P2Y12 inhibitor, in CHAMPION PHOENIX. METHODS AND RESULTS: A total of 11 145 patients were randomly assigned in a double-dummy, double-blind manner either to a cangrelor bolus and 2-h infusion or to clopidogrel at the time of PCI. The primary endpoint, a composite of death, myocardial infarction, ischaemia-driven revascularization, or stent thrombosis, and the primary safety endpoint, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) defined severe bleeding, were evaluated at 48 h. Of the patients undergoing PCI and receiving study drug treatment, a total of 8064 (74%) and 2855 (26%) patients underwent femoral or radial PCI, respectively. Among the femoral cohort, the primary endpoint rate was 4.8% with cangrelor vs. 6.0% with clopidogrel (odds ratio, OR [95% confidence interval, CI] = 0.79 [0.65-0.96]); among the radial cohort, the primary endpoint was 4.4% with cangrelor vs. 5.7% with clopidogrel (OR [95% CI] = 0.76 [0.54-1.06]), P-interaction 0.83. The rate of GUSTO severe bleeding in the femoral cohort was 0.2% with cangrelor vs. 0.1% with clopidogrel (OR [95% CI] = 1.73 [0.51-5.93]). Among the radial cohort, the rate of GUSTO severe bleeding was 0.1% with cangrelor vs. 0.1% with clopidogrel (OR [95% CI] = 1.02 [0.14-7.28]), P-interaction 0.65. The evaluation of safety endpoints with the more sensitive ACUITY-defined bleeding found major bleeding in the femoral cohort to be 5.2% with cangrelor vs. 3.1% with clopidogrel (OR [95% CI] = 1.69 [1.35-2.12]); among the radial cohort the rate of ACUITY major bleeding was 1.5% with cangrelor vs. 0.7% with clopidogrel (OR [95% CI] = 2.17 [1.02-4.62], P-interaction 0.54). CONCLUSION: In CHAMPION PHOENIX, cangrelor reduced ischaemic events with no significant increase in GUSTO-defined severe bleeding. The absolute rates of bleeding, regardless of the definition, tended to be lower when PCI was performed via the radial artery. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov identifier: NCT01156571.

Does Preoperative Platelet Function Predict Bleeding in Patients Undergoing Off Pump Coronary Artery Bypass Surgery?

OBJECTIVE: We sought to examine the relationship between preoperative platelet function and perioperative bleeding in patients undergoing CABG. BACKGROUND: There are many ways to measure platelet aggregability. Little is known about their correlations with one another, or with bleeding. METHODS: We prospectively studied 50 patients undergoing a first isolated off-pump CABG. Thirty-four were exposed to a thienopyridine prior to surgery; 16 were not. Preoperative platelet function was measured by VerifyNow®, TEG®, AggreGuide™, Plateletworks®, vasodilator-stimulated phosphoprotein (VASP) phosphorylation, and light transmission aggregometry. Bleeding was assessed 2 ways: drop from pre- to nadir postoperative hematocrit, and chest tube drainage. Correlation coefficients were calculated using Spearman's rank-order correlation. RESULTS: Mean age was 62 years. Patient characteristics and surgical details were similar between the thienopyridine-exposed and non-exposed patients. The correlation coefficients between the 4 point-of-care platelet function measurements and hematocrit change ranged from -0.2274 to 0.2882. Only Plateletworks® correlated with drop in hematocrit (r = 0.2882, P = 0.0470). The correlation coefficients between each of the 4 point-of-care platelet function tests and the chest tube drainage were also poor, ranging from -0.3073 to 0.2272. Both AggreGuide™ (r = -0.3073, P = 0.0317) and VASP (r = -0.3187, P = 0.0272) were weakly but significantly correlated with chest tube drainage. The correlation among the 4 point-of-care platelet function measurements was poor, with coefficients ranging from -0.2504 to 0.1968. CONCLUSIONS: We observed little correlation among 4 platelet function tests, and between those assays and perioperative bleeding defined 2 different ways. Whether any of these assays should be used to guide decision making in individual patients is unclear.

Readmission in the 30 days after percutaneous coronary intervention.

OBJECTIVES: This study sought to identify the frequency and etiology of readmission within 30 days of percutaneous coronary intervention (PCI) in a large integrated healthcare system. BACKGROUND: One-fifth of Medicare patients are readmitted within 30 days of hospitalization. Identifying the causes of readmission may help identify strategies to prevent readmission. METHODS: All patients undergoing PCI (elective, urgent, and emergent) at our center between January 1, 2007, and April 12, 2010, were prospectively entered into the American College of Cardiology National Cardiovascular Data Registry. Patients readmitted to any hospital within 30 days of the index procedure were identified using an administrative database and telephone follow-up. Individual charts were reviewed independently by 2 investigators; disagreements regarding the cause for readmission were resolved by a third investigator. RESULTS: During the study period, 3,255 PCI were performed, and 262 patients (8.0%) were readmitted within 30 days. Of these, 261 (99.6%) had medical records available for review. Reasons for readmission included: complications related to the PCI (n = 31, 11.9%); non-PCI cardiac causes related to index admission (n = 93, 35.6%); noncardiac causes related to index admission (n = 34, 13%); causes unrelated to the index admission (n = 103, 39.5%). Multivariable logistic regression modeling revealed that female sex, advanced age, peripheral arterial disease, prior valvular surgery, and PCI complications during the index procedure were associated with 30-day readmission. CONCLUSIONS: Readmissions within 30 days due to complications related to PCI performed on index admission are rare (0.9% of all PCI) and are an infrequent cause of readmission (<12% of readmissions). Thirty-day readmission after PCI should not be used as a quality metric of PCI performance.

Frequency of coronary angiography and revascularization among men and women with myocardial infarction and their relationship to mortality at one year: an analysis of the Geisinger myocardial infarction cohort.

OBJECTIVES: To determine sex bias in the selection of strategies to evaluate patients with acute myocardial infarction (AMI), and determine if the choice of strategy influences survival. BACKGROUND: Controversy exists regarding the role of female sex in the use of invasive evaluation for AMI and its possible effect on adverse outcomes. METHODS: Electronic health record data from the Geisinger Acute Myocardial Infarction Cohort (GAMIC) was analyzed which included 1,968 men and 1,047 women admitted to the Geisinger Medical Center between January 2001 and December 2006 with acute myocardial infarction (AMI).Multivariate logistic regression analyses were used to determine independent correlates of an invasive evaluation. Multivariate logistic regression modeling stratified on sex was used to determine when invasive evaluation was done and whether there was a correlation with mortality. RESULTS: In unadjusted analyses, male sex was a significant predictor for the use of invasive evaluation (odds ratio = 1.71, 95% CI = [1.46, 2.00]). Adjusted for baseline differences (like age, renal function, co-morbid conditions) multivariate analyses found no significant relationship between male sex and invasive evaluation (OR = 1.02, 95% CI = [0.82, 1.23]). Females in the STEMI group were found to be less revascularized. No difference was observed in the one-year mortality between women and men regardless of invasive evaluation or revascularization. CONCLUSIONS: Sex was not independently associated with the occurrence of an invasive evaluation of a MI. Females in the STEMI group were less revascularized. There was no strong gender effect on survival irrespective of the performance on an invasive evaluation or revascularization.