Best Practices for Cardiac Catheterization Laboratory Morbidity and Mortality Conferences.

Cardiac catheterization laboratory (CCL) morbidity and mortality conferences (MMCs) are a critical component of CCL quality improvement programs and are important for the education of cardiology trainees and the lifelong learning of CCL physicians and team members. Despite their fundamental role in the functioning of the CCL, no consensus exists on how CCL MMCs should identify and select cases for review, how they should be conducted, and how results should be used to improve CCL quality. In addition, medicolegal ramifications of CCL MMCs are not well understood. This document from the American College of Cardiology's Interventional Section attempts to clarify current issues and options in the conduct of CCL MMCs and to recommend best practices for their conduct.

Basal Cell Cancer of the Scalp.

Basal cell carcinoma (BCC) is generally uncovered in sun-exposed areas, secondary to chronic unprotected UV exposure. The most common sites for nodular basal cells are the face, especially the nose, cheeks, forehead, nasolabial folds, and eyelids, with a history of crusting and friability. The commencement of BCC is 10 to 15 years from epidermal damage. Here, we report the case of a 52-year-old Caucasian female who presented to her primary care with an enlarging bump on the scalp for the past five years, which became tender and friable two months before the visit. The patient was clinically diagnosed with a solitary cyst and was referred for surgical excision. The pathology of the excised specimen revealed it to be a BCC.

Multifaceted Intervention to Improve P2Y12 Inhibitor Adherence After Percutaneous Coronary Intervention: A Stepped Wedge Trial.

Background P2Y12 inhibitor medications are critical following percutaneous coronary intervention (PCI); however, adherence remains suboptimal. Our objective was to assess the effectiveness of a multifaceted intervention to improve P2Y12 inhibitor adherence following PCI. Methods and Results This was a modified stepped wedge trial of 52 eligible hospitals, of which 15 were randomly selected and agreed to participate (29 hospitals declined, and 8 eligible hospitals were not contacted). At each intervention hospital, patient recruitment occurred for 6 months and enrolled patients were followed up for 1 year after PCI. Three control groups were used: patients at intervention hospitals undergoing PCI (1) before the intervention period (preintervention); (2) after the intervention period (postintervention); or (3) at the 8 hospitals not contacted (concurrent controls). The intervention consisted of 4 components: (1) P2Y12 inhibitor delivered to patients' bedside after PCI; (2) education on importance of P2Y12 inhibitors; (3) automated reminder telephone calls to refill medication; and (4) outreach to patients if they delayed refilling P2Y12 inhibitor. The primary outcomes were as follows: (1) proportion of patients with delays filling P2Y12 inhibitor at hospital discharge and (2) proportion of patients who were adherent in the year after PCI using pharmacy refill data. Primary analysis compared intervention with preintervention control patients. There were 1377 (intent-to-treat) potentially eligible patients, of whom 803 (per protocol) were approached at intervention sites versus 5910 preintervention, 2807 postintervention, and 4736 concurrent control patients. In the intent-to-treat analysis, intervention patients were less likely to delay filling P2Y12 at hospital discharge (-3.4%; 98.3% CI, -1.2% to -5.6%) and more likely to be adherent to P2Y12 (4.1%; 98.3% CI, 1.0%-7.1%) at 1 year, but had more clinical events (3.2%; 98.3% CI, 2.3%-4.1%) driven by repeated PCI compared with preintervention patients. In post hoc analysis looking at myocardial infarction, stroke, and death, intervention patients had lower event rates compared with preintervention patients (-1.7%; 98.3% CI, -2.3% to -1.1%). Conclusions A 4-component intervention targeting P2Y12 inhibitor adherence was difficult to implement. The intervention produced mixed results. It improved P2Y12 adherence, but there was also an increase in repeat PCI. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01609842.

In-Stent Restenosis in Saphenous Vein Grafts (from the DIVA Trial).

Saphenous vein grafts (SVGs) have high rates of in-stent restenosis (ISR). We compared the baseline clinical and angiographic characteristics of patients and lesions that did develop ISR with those who did not develop ISR during a median follow-up of 2.7 years in the DIVA study (NCT01121224). We also examined the ISR types using the Mehran classification. ISR developed in 119 out of the 575 DIVA patients (21%), with similar incidence among patients with drug-eluting stents and bare-metal stents (BMS) (21% vs 21%, p = 0.957). Patients in the ISR group were younger (67 ± 7 vs 69 ± 8 years, p = 0.04) and less likely to have heart failure (27% vs 38%, p = 0.03) and SVG lesions with Thrombolysis In Myocardial Infarction 3 flow before the intervention (77% vs 83%, p <0.01), but had a higher number of target SVG lesions (1.33 ± 0.64 vs 1.16 ± 0.42, p <0.01), more stents implanted in the target SVG lesions (1.52 ± 0.80 vs 1.31 ± 0.66, p <0.01), and longer total stent length (31.37 ± 22.11 vs 25.64 ± 17.42 mm, p = 0.01). The incidence of diffuse ISR was similar in patients who received drug-eluting-stents and BMS (57% vs 54%, p = 0.94), but BMS patients were more likely to develop occlusive restenosis (17% vs 33%, p = 0.05).

Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions (SCAI) 2021 think tank.

The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community annually for high-level field-wide discussions. The 2021 Think Tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease. Each session was moderated by a senior content expert and co-moderated by a member of SCAI's Emerging Leader Mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialog from a broader base, and thereby aid SCAI, the industry community and external stakeholders in developing specific action items to move these areas forward.

Acute Kidney Injury Following In-Patient Lower Extremity Vascular Intervention: From the National Cardiovascular Data Registry.

OBJECTIVES: The authors analyzed data from the NCDR (National Cardiovascular Data Registry) PVI Registry and defined acute kidney injury (AKI) as increased creatinine of ≥0.3 mg/dl or 50%, or a new requirement for dialysis after PVI. BACKGROUND: AKI is an important and potentially modifiable complication of peripheral vascular intervention (PVI). The incidence, predictors, and outcomes of AKI after PVI are incompletely characterized. METHODS: A hierarchical logistic regression risk model using pre-procedural characteristics associated with AKI was developed, followed by bootstrap validation. The model was validated with data submitted after model creation. An integer scoring system was developed to predict AKI after PVI. RESULTS: Among 10,006 procedures, the average age of patients was 69 years, 58% were male, and 52% had diabetes. AKI occurred in 737 (7.4%) and was associated with increased in-hospital mortality (7.1% vs. 0.7%). Reduced glomerular filtration rate, hypertension, diabetes, prior heart failure, critical or acute limb ischemia, and pre-procedural hemoglobin were independently associated with AKI. The model to predict AKI showed good discrimination (optimism corrected c-statistic = 0.68) and calibration (corrected slope = 0.97, intercept of -0.07). The integer point system could be incorporated into a useful clinical tool because it discriminates risk for AKI with scores ≤4 and ≥12 corresponding to the lower and upper 20% of risk, respectively. CONCLUSIONS: AKI is not rare after PVI and is associated with in-hospital mortality. The NCDR PVI AKI risk model, including the integer scoring system, may prospectively estimate AKI risk and aid in deployment of strategies designed to reduce risk of AKI after PVI.

JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study.

PURPOSE: To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR). MATERIALS AND METHODS: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR (ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evaluate time-to-event endpoints; estimates are given with 95% confidence interval (CI). RESULTS: Bailout stenting was required in 6 of 60 limbs (10%). There were no stent fractures or deformities after atherectomy + adjunctive angioplasty reported by the core laboratory. Kaplan-Meier estimates of freedom from TLR at 6 months and 1 year were 79.3% (95% CI 68.9% to 89.8%) and 60.7% (95% CI 47.8% to 73.6%), respectively. When bailout stenting at the index procedure was not considered a TLR event, freedom from TLR estimates at 6 months and 1 year were 89.3% (95% CI 81.2% to 97.4%) and 66.8% (95% CI 54.3% to 74.2%), respectively. Clinical patency rates at 6 months and 1 year were 77.5% (31/40) and 51.7% (15/29), respectively. CONCLUSION: JetStream atherectomy using the XC device and no drug-eluting devices is feasible, with good clinical patency and 1-year freedom from TLR.

Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions 2020 think tank.

The society for cardiovascular angiography and interventions (SCAI) think tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community for high-level field-wide discussions. The 2020 think tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease (CHD). Each session was moderated by a senior content expert and co-moderated by a member of SCAI's emerging leader mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialogue from a broader base, and thereby aid SCAI and the industry community in developing specific action items to move these areas forward.

Plaque Regression and Endothelial Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen (PREMIER).

BACKGROUND: Low-density lipoproteins (LDLs) are removed by extracorporeal filtration during LDL apheresis. It is mainly used in familial hyperlipidemia. The PREMIER trial (Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen) evaluated LDL apheresis in nonfamilial hyperlipidemia acute coronary syndrome patients treated with percutaneous coronary intervention. METHODS: We randomized 160 acute coronary syndrome patients at 4 Veterans Affairs centers within 72 hours of percutaneous coronary intervention to intensive lipid-lowering therapy (ILLT) comprising single LDL apheresis and statins versus standard medical therapy (SMT) with no LDL apheresis and statin therapy alone. Trial objectives constituted primary safety and primary efficacy end points and endothelial progenitor cell colony-forming unit mobilization in peripheral blood. RESULTS: Mean LDL reduction at discharge was 53% in ILLT and 17% in SMT groups (P<0.0001) from baseline levels of 116.3±34.3 and 110.7±32 mg/dL (P=0.2979), respectively. The incidence of the primary safety end point of major peri-percutaneous coronary intervention adverse events was similar in both groups (ILLT, 3; SMT, 0). The primary efficacy end point, percentage change in total plaque volume at 90 days by intravascular ultrasound, on average decreased by 4.81% in the ILLT group and increased by 2.31% in the SMT group (difference of means, -7.13 [95% CI, -14.59 to 0.34]; P=0.0611). The raw change in total plaque volume on average decreased more in the ILLT group than in the SMT group (-6.01 versus -0.95 mm3; difference of means, -5.06 [95% CI, -11.61 to 1.48]; P=0.1286). Similar results were obtained after adjusting for participating sites, age, preexisting coronary artery disease, diabetes mellitus, baseline LDL levels, and baseline plaque burden. There was robust endothelial progenitor cell colony-forming unit mobilization from baseline to 90 days in the ILLT group (P=0.0015) but not in SMT (P=0.0844). CONCLUSIONS: PREMIER is the first randomized clinical trial to demonstrate safety and a trend for early coronary plaque regression with LDL apheresis in nonfamilial hyperlipidemia acute coronary syndrome patients treated with percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01004406 and NCT02347098.

Prognostic Value of 6-Minute Walk Distance in Patients Undergoing Percutaneous Coronary Intervention: a Veterans Affairs Prospective Study.

The 6-minute walk distance (6MWD) test is a useful prognostic tool in chronic heart failure. Its usefulness after percutaneous coronary intervention is unknown. In a prospective observational study, patients underwent a 6MWD test within 2 weeks after percutaneous coronary intervention. The primary endpoint was major adverse cardiovascular events (MACE) (death, acute coronary syndrome, and heart failure admission) at one year. Receiver operating characteristic curves and area under the curve were used to determine the 6MWD test's predictive power, and the Youden index was used to measure its effectiveness. A total of 212 patients were enrolled (98% men; mean age, 65 ± 9 yr). Major comorbidities were hypertension in 187 patients (88%), dyslipidemia in 186 (88%), and diabetes mellitus in 95 (45%). Among the 176 patients (83%) who completed the 6MWD test, the incidence of MACE at one year was 22% (acute coronary syndrome in 17%; heart failure admission in 4%; and death in 3%). The area under the curve for MACE was 0.59, and 6MWD was shorter for patients with MACE than for those without (290 vs 326 m; P=0.03). For 39 patients with previous heart failure who completed the 6MWD test, the area under the curve was 0.64 for MACE and 0.78 for heart failure admission. The 6MWD test predicted reasonably well the incidence of MACE one year after percutaneous coronary intervention. In a subgroup of patients with previous heart failure, it fared even better in predicting heart failure admission. Larger studies are needed to confirm these findings.

Stent-Only Versus Adjunctive Balloon Angioplasty Approach for Saphenous Vein Graft Percutaneous Coronary Intervention: Insights From DIVA Trial.

BACKGROUND: Direct stenting without pre-dilation or post-dilation has been advocated for saphenous vein graft percutaneous coronary intervention to decrease the incidence of distal embolization, periprocedural myocardial infarction, and target lesion revascularization. METHODS: We performed a post hoc analysis of patients enrolled in the DIVA (Drug-Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Angioplasty; NCT01121224) prospective, double-blind, randomized controlled trial. Patients were stratified into stent-only and balloon-stent groups. Primary end point was 12-month incidence of target vessel failure (defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization). Secondary end points included all-cause death, stent thrombosis, myocardial infarction, and target lesion revascularization during follow-up. RESULTS: Of the 575 patients included in this substudy, 185 (32%) patients underwent stent-only percutaneous coronary intervention. Patients in the stent-only versus balloon-stent group had similar baseline characteristics and similar incidence of target vessel failure at 12-months (15% versus 19%; hazard ratio, 1.34 [95% CI, 0.86-2.08]; P=0.19). During long-term follow-up (median of 2.7 years), the incidence of definite stent thrombosis (1% versus 5%; hazard ratio, 9.20 [95% CI, 1.23-68.92]; P=0.0085), the composite of definite or probable stent thrombosis (5% versus 11%; hazard ratio, 2.52 [95% CI, 1.23-5.18]; P=0.009), and target vessel myocardial infarction (8% versus 14%; hazard ratio, 1.92 [95% CI, 1.08-3.40]; P=0.023) was lower in the stent-only group. Multivariable analysis showed that a higher number of years since coronary artery bypass grafting and >1 target saphenous vein graft lesions were associated with increased target vessel failure during entire follow-up, while preintervention Thrombolysis in Myocardial Infarction-3 flow was protective. CONCLUSIONS: In patients undergoing percutaneous coronary intervention of de novo saphenous vein graft lesions, there was no difference in target vessel failure at 12 months and long-term follow-up in the stent-only versus the balloon-stent group; however, the incidence of stent thrombosis was lower in the stent-only group, as was target vessel myocardial infarction. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01121224.

Expanding opportunities to understand quality and outcomes of peripheral vascular interventions: The ACC NCDR PVI Registry.

Lower extremity peripheral artery disease (PAD) and cerebrovascular disease (CeVD) are prevalent conditions in the United States, and both are associated with significant morbidity (eg, stroke, myocardial infarction, and limb loss) and increased mortality. With a growth in invasive procedures for PAD and CeVD, this demands a more clear responsibility and introduces an opportunity to study how patients are treated and evaluate associated outcomes. The American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) Registry is a prospective, independent collection of data elements from individual patients at participating centers, and it is a natural extension of the already robust NCDR infrastructure. As of September 20, 2018, data have been collected on 45,316 lower extremity PVIs, 12,417 carotid artery stenting procedures, and 11,027 carotid endarterectomy procedures at 208 centers in the United States. The purpose of the present report is to describe the patient and procedural characteristics of the overall cohort and the methods used to design and implement the registry. In collecting these data, ACC and ACC PVI Registry have the opportunity to play a pivotal role in scientific evidence generation, medical device surveillance, and creation of best practices for PVI and carotid artery revascularization.

Drug-eluting stents versus bare-metal stents in saphenous vein grafts: a double-blind, randomised trial.

BACKGROUND: Few studies have examined the efficacy of drug-eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure compared with bare-metal stents (BMS) in patients undergoing stenting of de-novo SVG lesions. We assessed the risks and benefits of the use of DES versus BMS in de-novo SVG lesions. METHODS: Patients were recruited to our double-blind, randomised controlled trial from 25 US Department of Veterans Affairs centres. Eligible participants were aged at least 18 years and had at least one significant de-novo SVG lesion (50-99% stenosis of a 2·25-4·5 mm diameter SVG) requiring percutaneous coronary intervention with intent to use embolic protection devices. Enrolled patients were randomly assigned, in a 1:1 ratio, by phone randomisation system to receive a DES or BMS. Randomisation was stratified by presence or absence of diabetes and number of target SVG lesions requiring percutaneous coronary intervention (one or two or more) within each participating site by use of an adaptive scheme intended to balance the two stent type groups on marginal totals for the stratification factors. Patients, referring physicians, study coordinators, and outcome assessors were masked to group allocation. The primary endpoint was the 12-month incidence of target vessel failure, defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularisation. The DIVA trial is registered with ClinicalTrials.gov, number NCT01121224. FINDINGS: Between Jan 1, 2012, and Dec 31, 2015, 599 patients were randomly assigned to the stent groups, and the data for 597 patients were used. The patients' mean age was 68·6 (SD 7·6) years, and 595 (>99%) patients were men. The two stent groups were similar for most baseline characteristics. At 12 months, the incidence of target vessel failure was 17% (51 of 292) in the DES group versus 19% (58 of 305) in the BMS group (adjusted hazard ratio 0·92, 95% CI 0·63-1·34, p=0·70). Between-group differences in the components of the primary endpoint, serious adverse events, or stent thrombosis were not significant. Enrolment was stopped before the revised target sample size of 762 patients was reached. INTERPRETATION: In patients undergoing stenting of de-novo SVG lesions, no significant differences in outcomes between those receiving DES and BMS during 12 months of follow-up were found. The study results have important economic implications in countries with high DES prices such as the USA, because they suggest that the lower-cost BMS can be used in SVG lesions without compromising either safety or efficacy. FUNDING: US Department of Veterans Affairs Cooperative Studies Program.

Temporal Trends and Outcomes of Patients Undergoing Percutaneous Coronary Interventions for Cardiogenic Shock in the Setting of Acute Myocardial Infarction: A Report From the CathPCI Registry.

OBJECTIVES: The purpose of this study was to examine the temporal trends in demographics, clinical characteristics, management strategies, and in-hospital outcomes in patients with acute myocardial infarction complicated by cardiogenic shock (CS-AMI) who underwent percutaneous coronary intervention (PCI) from the Cath-PCI Registry (2005 to 2013). BACKGROUND: The authors examined contemporary use and outcomes of PCI in patients with CS-AMI. METHODS: The authors used the Cath-PCI Registry to evaluate 56,497 patients (January 2005 to December 2013) undergoing PCI for CS-AMI. Temporal trends in clinical variables and outcomes were assessed. RESULTS: Compared with cases performed from 2005 to 2006, CS-AMI patients receiving PCI from 2011 to 2013 were more likely to have diabetes, hypertension, dyslipidemia, previous PCI, dialysis, but less likely to have chronic lung disease, peripheral vascular disease, or heart failure within 2 weeks (p < 0.01). Between 2005 and 2006 to 2011 and 2013, intra-aortic balloon pump use decreased (49.5% to 44.9%; p < 0.01), drug-eluting stent use declined (65% to 46%; p < 0.01), and the use of bivalirudin increased (12.6% to 45.6%). Adjusted in-hospital mortality; increased (27.6% in 2005 to 2006 vs. 30.6% in 2011 to 2013, adjusted odds ratio: 1.09, 95% confidence interval: 1.005 to .173; p = 0.04) for patients who were managed with an early invasive strategy (<24 h from symptoms). CONCLUSIONS: Our study shows that despite the evolution of medical technology and use of contemporary therapeutic measures, in-hospital mortality in CS-AMI patients who are managed invasively continues to rise. Additional research and targeted efforts are indicated to improve outcomes in this high-risk cohort.

Radiation Safety During Interventions of Coronary Chronic Total Occlusion

During percutaneous coronary interventions (PCI) for chronic total occlusion (CTO), prolonged procedures increase the risk of excessive radiation exposure. These situations harbor a major concern to protect patients and personnel in the cardiac interventional laboratory (CCL). Important questions regarding radiation safety for interventional cardiologists performing PCI for CTO lesions are discussed and concrete applications are suggested.