Osvaldo Gigliotti

SCAI expert consensus statement for aorto-iliac arterial intervention appropriate use.

Aorto‐iliac arterial occlusive disease is common and may cause a spectrum of chronic symptoms from intermittent claudication to critical limb ischemia. Treatment is indicated for symptoms that have failed lifestyle and medical therapies or occasionally to facilitate other interventional procedures such as TAVR and/or placement of hemodynamic assist devices. It is widely accepted that TASC A, B, and C lesions are best managed with endovascular intervention. In experienced hands, most TASC D lesions may be treated by endovascular methods, and with the development of chronic total occlusion devices, many aorto‐iliac occlusions may be recanalized safely by endovascular means. Interventional cardiologists should be well versed in the anatomy, as well as the treatment of aorto‐iliac disease, given their need to traverse these vessels during transfemoral procedures. Overall, aorto‐iliac occlusive disease is more commonly being treated with an endovascular‐first approach, using open surgery as a secondary option. This document was developed to guide physicians in the clinical decision‐making related to the contemporary application of endovascular intervention among patients with aorto‐iliac arterial disease.

Femoropopliteal Artery Stent Thrombosis Report From the Excellence in Peripheral Artery Disease Registry

Background—There are limited data on femoropopliteal artery stent thrombosis (ST), which is a serious adverse outcome of peripheral artery interventions. Methods and Results—Index procedures resulting in femoropopliteal ST were compared with stent procedures without subsequent ST in the Excellence in Peripheral Artery Disease registry. The study data had a total of 724 cases of stent procedures and 604 unique patients. Femoropopliteal ST occurred in 26 of 604 patients (4.3%) over a median follow-up of 6 months post procedure. ST was more likely to occur in men (96.3% versus 82.2%; P=0.026) and to have an initial intervention for chronic total occlusions (88.5% versus 64.0%; P=0.01). There was no significant difference in ST between drug-coated and bare-metal stents (4.4% versus 3.4%; P=0.55), but the rate of ST was significantly higher with self-expanding covered stent grafts compared with bare-metal stents (10.6% versus 3.4%; P=0.02). ST was significantly associated with an increased risk of 12-month major adverse limb events (hazard ratio, 4.99; 95% confidence interval, 2.31–10.77; P<0.001) compared with no ST. On multivariate analysis, treatment of chronic total occlusion lesions (odds ratio, 3.46; 95% confidence interval, 0.98–12.20; P=0.05) and in-stent restenosis lesions (odds ratio, 5.30; 95% confidence interval, 1.83–15.32; P=0.002) were independently associated with an increased risk of ST. Conclusions—In a multicenter peripheral interventional registry, femoropopliteal ST occurred in 4.3% of patients who underwent stent procedures, and it was associated with treatment of chronic total occlusions and in-stent restenosis lesions, and had higher 12-month major adverse limb events. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01904851.

The State of the Absorb Bioresorbable Scaffold: Consensus From an Expert Panel

Significant progress has been made in the percutaneous coronary intervention technique from the days of balloon angioplasty to modern-day metallic drug-eluting stents (DES). Although metallic stents solve a temporary problem of acute recoil following balloon angioplasty, they leave behind a permanent problem implicated in very late events (in addition to neoatherosclerosis). BRS were developed as a potential solution to this permanent problem, but the promise of these devices has been tempered by clinical trials showing increased risk of safety outcomes, both early and late. This is not too dissimilar to the challenges seen with first-generation DES in which refinement of deployment technique, prolongation of dual antiplatelet therapy, and technical iteration mitigated excess risk of very late stent thrombosis, making DES the treatment of choice for coronary artery disease. This white paper discusses the factors potentially implicated in the excess risks, including the scaffold consideration and deployment technique, and outlines patient and lesion selection, implantation technique, and dual antiplatelet therapy considerations to potentially mitigate this excess risk with the first-generation thick strut Absorb scaffold (Abbott Vascular, Abbott Park, Illinois). It remains to be seen whether these considerations together with technical iterations will ultimately close the gap between scaffolds and metal stents for short-term events while at the same time preserving options for future revascularization once the scaffold bioresorbs.

2016 Revision of the SCAI Position Statement on Public Reporting

The public reporting of institutional and individual operator results of percutaneous coronary interventions (PCIs) is intended to provide meaningful information to the public and enhance the delivery of superlative health care. By giving consumers specific outcome data [1], patients will be empowered to participate more fully in decisions concerning their medical care. The influence that public reports wield could increase if publicly reported information proves to be an accurate representation of “value” in health care delivery, and if third-party payers use this information to allocate reimbursement in a value-based system [2]. Despite these well-intended goals, there is uncertainty whether existing programs correctly identify highand low-performing PCI centers and operators. Moreover, there is emerging evidence that public reporting can deleteriously influence case selection by encouraging risk avoidance behaviors. Thus, potentially beneficial procedures might be withheld from high-risk patients who can derive the greatest benefit, because operators and facilities fear being labeled as outliers [3–8]. This position statement updates the prior Society for Cardiac Angiography and Interventions (SCAI) Policy on Public Reporting [1]. SCAI continues to endorse public reporting, provided the reports are not misleading, deliver meaningful information to consumers to help inform their choices, and facilitate quality improvement. Offering the public accurate and understandable metrics, including measures to assess the appropriateness of case selection, are essential to achieve this aim.

Optimal use of left ventriculography at the time of cardiac catheterization: A consensus statement from the society for cardiovascular angiography and interventions

The rationale to perform left ventriculography at the time of cardiac catheterization has been little studied. The technique and frequency of use of left ventriculography vary by geographic regions, institutions, and individuals. Despite the recent publication of guidelines and appropriate use criteria for coronary angiography, revascularization, and noninvasive imaging, to date there have been no specific guidelines on the performance of left ventriculography. When left ventriculography is performed, proper technique must be used to generate high quality data which can direct patient management. The decision to perform left ventriculography in place of, or in addition to, other forms of ventricular assessment should be made taking into account the clinical context and the type of information each study provides. This paper attempts to show the role of left ventriculography at the time of coronary angiography or left heart catheterization. The recommendations in this document are not formal guidelines but are based on the consensus of this writing group. These recommendations should be tested through clinical research studies. Until such studies are performed, the writing group believes that adoption of these recommendations will lead to a more standardized application of ventriculography and improve the quality of care provided to cardiac patients.

SCAI appropriate use criteria for peripheral arterial interventions: An update

Andrew J. Klein, MD, FSCAI1 | Michael R. Jaff, DO, FSCAI2 | Bruce H. Gray, DO, FSCAI3 | Herbert D. Aronow, MD, MPH, FSCAI4 | Robert M. Bersin, MD, MPH, FSCAI5 | Larry J. Diaz-Sandoval, MD, FSCAI6 | Robert S. Dieter, MD, RVT, FSCAI7 | Douglas E. Drachman, MD, FSCAI8 | Dmitriy N. Feldman, MD, FSCAI9 | Osvaldo S. Gigliotti, MD, FSCAI10 | Kamal Gupta, MD, FSCAI11 | Sahil A. Parikh, MD, FSCAI12 | Duane S. Pinto, MD, MPH, FSCAI13 | Mehdi H. Shishehbor, DO, MPH, PhD, FSCAI14 | Christopher J. White, MD, MSCAI15

SCAI consensus guidelines for device selection in femoral-popliteal arterial interventions

Weill Cornell Medical College, New York, New York University of Colorado School of Medicine, Aurora, Colorado The Warren Alpert Medical School of Brown University, Providence, Rhode Island Seton Heart Institute, Austin, Texas Newton-Wellesley Hospital, Newton, Massachusetts Piedmont Heart Institute, Atlanta, Georgia Columbia University Medical Center, New York, New York UT Health Science Center at San Antonio, Texas Massachusetts General Hospital, Boston, Massachusetts University Hospitals Cleveland Medical Center, Cleveland, Ohio Duke University Medical Center, Durham, North Carolina Ochsner Medical Center, New Orleans, Louisiana

Outcomes in women and minorities compared with white men 1 year after everolimus-eluting stent implantation: Insights and results from the PLATINUM diversity and PROMUS element plus post-approval study pooled analysis

Importance There exist limited outcomes data for women and minorities after contemporary percutaneous coronary intervention (PCI). Objective To examine 1-year outcomes in women and minorities vs white men after PCI with everolimus-eluting stents. Design, Settings, and Participants The PLATINUM Diversity study was a single-arm study enrolling women and minorities. Patient-level pooling with the PROMUS Element Plus Post-Approval Study was prespecified. Data on social determinants of health and language were collected in the PLATINUM Diversity cohort, which included 1501 patients at 52 US sites. The PROMUS Element Plus Post-Approval study enrolled 2681 patients at 52 US sites with some site overlap and included an “all-comers” population. All patients were enrolled beginning in October 2014 and were followed for 12 months. Analyses began in August 2016. Interventions Patients received 1 or more everolimus-eluting stent implantation. Main Outcomes and Measures The primary end point was 1-year major adverse cardiac events (MACE), which included death/myocardial infarction (MI)/target vessel revascularization. Secondary ischemic end points were also evaluated. Results The pooled study consisted of 4182 patients: 1635 white men (39.1%), 1863 women (white and minority) (44.5%), and 1059 minority patients (women and men) (25.3%). Women and minorities had a higher prevalence of diabetes, prior stroke, hypertension, renal disease, and congestive heart failure than white men but lower rates of multivessel disease, prior coronary artery bypass graft surgery, prior MI, and smoking. Unadjusted 1-year MACE rates (white men, 7.6%; women, 8.6%; minorities, 9.6%) were similar between groups with no significant differences after risk adjustment. The adjusted risk of death/MI was higher among women (odds ratio, 1.6; 95% CI, 1.1-2.4) and minorities (odds ratio, 1.9; 95% CI, 1.2-2.8) compared with white men and the adjusted risk of MI was higher in minorities (odds ratio, 2.6; 95% CI, 1.4-4.8). These differences were driven primarily by nonstent-related MIs. Within the PLATINUM Diversity cohort, the independent predictors of MACE were cardiogenic shock, renal disease, history of peripheral vascular disease, multivessel disease, widowhood, and lack of private insurance. Conclusions and Relevance After contemporary everolimus-eluting stent implantation, women and minorities experience a similar risk of 1-year MACE but a higher adjusted risk of recurrent ischemic events primarily because of nonstent-related MIs. Both clinical and angiographic factors and social determinants of health, including widowhood and insurance status, contribute to 1-year MACE among women and minorities.

ZILVER PTX DRUG-COATED PERIPHERAL ARTERY STENT USE IN A U.S. MULTICENTER REGISTRY

There are limited data regarding frequency of use and outcomes of the only approved drug coated stent (DCS; Zilver PTX®; Cook) during endovascular revascularization of infrainguinal arteries. We compared DCS to bare metal stent (BMS) use in procedures performed from January 2013 - August 2014,

PERIPHERAL ARTERY STENT THROMBOSIS: REPORT FROM THE EXCELLENCE IN PERIPHERAL ARTERY DISEASE (XLPAD) REGISTRY

There are limited data on infrainguinal peripheral artery stent thrombosis (ST). We analyzed procedures performed between May 2005-March 2014 enrolled in the XLPAD registry. Occurrence of ST was determined by acute onset of lower limb pain and angiographic evidence of thrombus. ST occurred in 27