Comparison of devices used in carotid artery stenting: A vascular quality initiative analysis of commonly used carotid stents and embolic protection devices.

BACKGROUND: Data regarding efficacy of various stent and embolic protection device (EPD) combinations to prevent stroke during carotid artery stenting (CAS) is limited. We compared post-procedure inpatient neurologic outcomes across various carotid stent-EPD platforms recorded in the Vascular Quality Initiative (VQI) registry. METHODS: We analyzed 13,786 consecutive CAS procedures in the VQI registry performed between January 1, 2005 and December 31, 2015. The most commonly used stent-EPD combinations (n = 5407) were included in the analysis. Post-procedure inpatient neurologic outcomes included (1) ipsilateral stroke/transient ischemic attack (TIA) and (2) any stroke/TIA. Multivariate generalized estimating equation regression analysis was performed, adjusting for age, sex, tobacco use, coronary artery disease, congestive heart failure, prior stroke/TIA, hypertension, history of carotid revascularization, and presence of a second ipsilateral stenosis >70%, to determine whether risk of outcomes differed according to device. RESULTS: Of 13,786 CAS procedures, Xact-Emboshield (n = 2,438, 17.6%), Precise-Angioguard (n = 1,480, 10.7%), Acculink-Accunet (n = 829, 6.01%), and Acculink-Emboshield (n = 660, 4.8%) were the most commonly used combinations, accounting for a total of 5,407 procedures. Inpatient event rates for ipsilateral stroke/TIA and any stroke/TIA were 1.9 and 2.7% in the Accunet-Acculink, 3.0 and 3.2% in Acculink-Emboshield, 3.2 and 4.1% in Precise-Angioguard and 2.2 and 3.0% in Xact-Emboshield. There was no evidence of difference in risk of ipsilateral stroke/TIA or any stroke/TIA across device combinations (P = 0.15 and P = 0.16, respectively). CONCLUSION: CAS with current carotid stent-EPD combinations is associated with low rates of inpatient stroke/TIA. There is no statistically significant difference in rates of inpatient stroke/TIA across device combinations.

Transcatheter Aortic Valve Replacement for Severe Aortic Regurgitation in Patients With a Left Ventricular Assist Device.

BACKGROUND: There are limited invasive treatment options for patients with end-stage heart failure and left ventricular assist device (LVAD) who develop severe aortic valve regurgitation (AR). One option for such patients is transcatheter aortic valve replacement (TAVR). There are limited data on outcomes of patients with LVAD who receive TAVR for severe AR. We present a series of 4 consecutive patients with LVAD who underwent TAVR for severe AR. METHODS AND RESULTS: This is a retrospective chart review of 4 consecutive patients with LVAD who underwent TAVR for severe AR. All 4 patients underwent TAVR with a 34-mm self-expanding valve (Medtronic). One patient received a 29-mm balloon-expandable valve (Edwards Lifesciences) within the self-expanding valve (SEV) to postdilate the SEV and minimize paravalvular leak (PVL). All 4 procedures were technically successful. The patient who received rescue valve-in-valve TAVR continued to have persistent mild to moderate PVL. CONCLUSION: Although technically challenging, TAVR is a feasible option for carefully selected LVAD patients with severe AR. Procedural issues to consider include oversizing the transcatheter heart valve (THV) while being cognizant of the risks of annular rupture and valve dislocation, anticipating and avoiding ventricular migration of the THV and being ready to postdilate the THV if necessary, to limit hemodynamically significant PVL.

Use of the CardioHELP Device for Temporary Hemodynamic Support During High-Risk Percutaneous Coronary Intervention.

BACKGROUND: Temporary extracorporeal membrane oxygenation (ECMO) support for high-risk percutaneous coronary intervention (PCI) has been described in select patients, and data are limited on the CardioHELP device (Maquet). The objective of this study was to assess clinical outcomes in patients undergoing elective, high-risk PCI with CardioHELP support. METHODS: Fifteen consecutive patients receiving the CardioHELP device for elective, high-risk PCI treated at 2 medical centers were included. Patients with cardiogenic shock, cardiac arrest, or non-PCI indications for ECMO were excluded. Baseline demographics, angiographic variables, procedure-related variables, and in-hospital events were collected. RESULTS: Mean age was 71 ± 11 years, 73% were male, mean ejection fraction (EF) was 29 ± 13%, 10 patients (67%) had an EF <30%, and mean SYNTAX I score was 32 ± 11. Multivessel coronary artery disease was present in 14 patients (93%) and unprotected left main coronary artery disease was present in 4 patients (27%). PCI was successful in all patients. In-hospital mortality occurred in 3 patients (20%), 7 patients (47%) received a blood transfusion, and there were no major vascular complications. CONCLUSION: Temporary use of the CardioHELP device for high-risk PCI is associated with acceptable short-term outcome and may be a new option for patients with complex coronary artery disease and left ventricular dysfunction.

Therapeutic Window of Clopidogrel and Ticagrelor in Patients With Critical Limb-Threatening Ischemia.

BACKGROUND: Critical limb-threatening ischemia (CLTI) is associated with an increased risk of major adverse limb events and mortality. High on-treatment platelet reactivity (HPR) is associated with an increased risk of ischemic events, while low on-treatment platelet reactivity (LPR) is associated with an increased risk of bleeding. This study investigates the frequency with which patients with CLTI on clopidogrel or ticagrelor achieve a "therapeutic window" (TW) of platelet inhibition. METHODS: Data from the "Switch To Ticagrelor in Critical Limb Ischemia Anti-Platelet Study" were assessed retrospectively to determine the incidence of TW of on-treatment platelet reactivity in 50 consecutive patients with CLTI (mean age: 65.2 ± 10.5 years, 54% male). The data included 4 measurements of patients' platelet reactivity using the VerifyNow P2Y12 Assay: baseline and steady state platelet reactivity on clopidogrel 75 mg daily and on ticagrelor 90 mg twice daily. RESULTS: At baseline, 46% of patients on clopidogrel were within TW of on-treatment platelet reactivity compared to 10% of patients on ticagrelor (P < .0001). At steady state, 42% of patients on clopidogrel were within the TW compared to 10% of patients on ticagrelor (P < .0001). Patients on ticagrelor exhibited higher rates of LPR compared to those on clopidogrel at baseline as well as at steady state (baseline 88% vs 18%, steady state 88% vs 28%; P < .0001). CONCLUSION: Although ticagrelor has been proposed as an alternative for patients with HPR on clopidogrel, the current study observes an excess of platelet inhibition with ticagrelor in most patients with CLTI at a dose of 90 mg twice daily.

In-Hospital Outcomes of Rotational Atherectomy in High-Risk Patients With Severely Calcified Left Main Coronary Artery Disease: A Single-Center Experience.

BACKGROUND: Severe coronary artery calcification is a challenge for percutaneous coronary intervention (PCI), particularly in left main coronary artery disease (LM-CAD). Rotational atherectomy (RA) is a useful tool for modification of calcified plaque prior to PCI. We report our experience with RA for severely calcified LM-CAD. METHODS: From January 2008 to January 2017, all patients who underwent RA-assisted LM-PCI were evaluated. The study population included both protected and unprotected LM-CAD patients. Clinical characteristics and in-hospital outcomes were collected retrospectively. In-hospital outcomes included post-PCI myocardial infarction, stroke, death, emergency coronary artery bypass graft surgery, and urgent repeat PCI. Angiographic success was defined by residual stenosis <20% and presence of TIMI 3 flow. RESULTS: Fifty-five consecutive patients who underwent RA-assisted PCI of LM-CAD were identified (mean age, 73.0 ± 10 years; 64% male). Mean left ventricular ejection fraction was 37.5 ± 15.7%. Fifty-one patients (93%) had multivessel disease and 39 patients (71%) underwent RA-assisted LM-PCI with use of a mechanical support device. The median largest burr size used was 1.5 mm. The mean number of LM stents implanted was 0.95 ± 0.3. The mean LM stent diameter and length were 3.7 ± 0.3 mm and 15.8 ± 7.5 mm, respectively. Intravascular ultrasound was used to assess vessel size and stent apposition in 20 patients (36.0%). Angiographic success was obtained in all patients (100%). CONCLUSION: Despite technical challenges, RA of the LM coronary artery can be performed safely and is associated with a high rate of angiographic success.

Long-term outcomes of drug-eluting stents versus bare metal stents in saphenous vein graft interventions. Evidence from a meta-analysis of randomized controlled trials.

BACKGROUND: The optimal stent for use in saphenous vein graft (SVG) intervention is still debatable. Multiple randomized trials have compared drug-eluting stents (DES) to bare metal stents (BMS) in SVG interventions with conflicting results. METHODS: Authors searched the online databases for randomized controlled trials (RCTs) comparing DES to BMS in SVG percutaneous coronary interventions (PCI). We performed a meta-analysis using a random effects model to calculate the odds ratio for outcomes of interest. RESULTS: Authors studied six RCTs that included 1592 patients undergoing PCI of SVG. The mean follow up was 42 months. Patients mean age was the same in both groups: 70.3 years in the DES group (approximately 93.3% male) and 70.3 years in the BMS group (approximately 93.8% male). Vein graft age was 13.4 years in the DES PCI arm vs. 13.4 years in the BMS PCI arm. Four of the six trials reported data on embolic protection device use: 67% (303/452) in the DES arm vs. 67.9% (309/455) in the BMS arm. The primary outcome of long-term all-cause mortality was not different between DES vs. BMS (15.2% vs. 14.1%, OR 1.12, 95% CI 0.67-1.88; P = 0.66). Secondary outcomes were also similar between DES and BMS: major adverse cardiovascular events (31.6% vs. 33.1%, OR 0.79, 95% CI 0.45-1.38; P = 0.41); cardiac death (9% vs. 8.6%, OR 1.12, 95% CI 0.55-2.30; P = 0.75); myocardial infarction (8% vs. 9.5%, OR 0.84, 95% CI 0.47-1.51; P = 0.57); target lesion revascularization (16.4% vs. 14.4%, OR 0.98, 95% CI 0.50-1.92; P = 0.95); and target vessel revascularization (19% vs. 19.4%, OR 0.75, 95% CI 0.41-1.34; P = 0.33). CONCLUSION: At a mean follow-up of 42 months, no difference was observed in clinical outcomes between DES and BMS in SVG interventions.