Left Atrial Appendage Occlusion in Patients With Anticoagulation Failure vs Anticoagulation Contraindication.

BACKGROUND: Left atrial appendage occlusion (LAAO) provides mechanical cardioembolic protection for atrial fibrillation (AF) patients who cannot use oral anticoagulation therapy (OAT). Patients with a thrombotic event despite OAT are at high risk for recurrence and may also benefit from LAAO. OBJECTIVES: This study sought to investigate the efficacy of LAAO in AF patients with a thrombotic event on OAT compared to: 1) LAAO in AF patients with a contraindication for OAT; and 2) historical data. METHODS: The international LAAO after stroke despite oral anticoagulation (STR-OAC LAAO) collaboration included patients who underwent LAAO because of thrombotic events on OAT. This cohort underwent propensity score matching and was compared to the EWOLUTION (Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology) registry, which represents patients who underwent LAAO because of OAT contraindications. The primary outcome was ischemic stroke. Event rates were compared between cohorts and with historical data without OAT, yielding relative risk reductions based on risk scores. RESULTS: Analysis of 438 matched pairs revealed no significant difference in the ischemic stroke rate between the STR-OAC LAAO and EWOLUTION cohorts (2.5% vs 1.9%; HR: 1.37; 95% CI: 0.72-2.61). STR-OAC LAAO patients exhibited a higher thromboembolic risk (HR: 1.71; 95% CI: 1.04-2.83) but lower bleeding risk (HR: 0.39; 95% CI: 0.18-0.88) compared to EWOLUTION patients. The mortality rate was slightly higher in EWOLUTION (4.3% vs 6.9%; log-rank P = 0.028). Relative risk reductions for ischemic stroke were 70% and 78% in STR-OAC LAAO and EWOLUTION, respectively, compared to historical data without OAT. CONCLUSIONS: LAAO in patients with a thrombotic event on OAT demonstrated comparable stroke rates to the OAT contraindicated population in EWOLUTION. The thromboembolic event rate was higher and the bleeding rate lower, reflecting the intrinsically different risk profile of both populations. Until randomized trials are available, LAAO may be considered in patients with an ischemic event on OAT.

Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study.

OBJECTIVES: The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study (HRS) assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, California) in patients with significant mitral regurgitation (MR) at high risk of surgical mortality rate. BACKGROUND: Patients with severe MR (3 to 4+) at high risk of surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR. METHODS: Patients with severe symptomatic MR and an estimated surgical mortality rate of ≥12% were enrolled. A comparator group of patients screened concurrently but not enrolled were identified retrospectively and consented to compare survival in patients treated by standard care. RESULTS: Seventy-eight patients underwent the MitraClip procedure. Their mean age was 77 years, >50% had previous cardiac surgery, and 46 had functional MR and 32 degenerative MR. MitraClip devices were successfully placed in 96% of patients. Protocol-predicted surgical mortality rate in the HRS and concurrent comparator group was 18.2% and 17.4%, respectively, and Society of Thoracic Surgeons calculator estimated mortality rate was 14.2% and 14.9%, respectively. The 30-day procedure-related mortality rate was 7.7% in the HRS and 8.3% in the comparator group (p = NS). The 12-month survival rate was 76% in the HRS and 55% in the concurrent comparator group (p = 0.047). In surviving patients with matched baseline and 12-month data, 78% had an MR grade of ≤2+. Left ventricular end-diastolic volume improved from 172 ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p = 0.001). New York Heart Association functional class improved from III/IV at baseline in 89% to class I/II in 74% (p < 0.0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 [p = 0.014] and the mental component score from 45.5 to 48.7 [p = 0.065]) at 12 months. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32 (p = 0.034). CONCLUSIONS: The MitraClip device reduced MR in a majority of patients deemed at high risk of surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months. (Pivotal Study of a Percutaneous Mitral Valve Repair System [EVEREST II]; NCT00209274).

Randomized comparison of everolimus- and paclitaxel-eluting stents. 2-year follow-up from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) IV trial.

OBJECTIVES: We sought to determine whether the differences in outcomes present between everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) IV trial at 1 year were sustained with longer-term follow-up. BACKGROUND: In the SPIRIT IV trial, patients undergoing percutaneous coronary intervention who were randomized to EES compared with PES experienced lower 1-year rates of target lesion failure (cardiac death, target vessel myocardial infarction [MI], or ischemia-driven target lesion revascularization [TLR]), with significant reductions in the individual rates of MI, TLR, and stent thrombosis. METHODS: We prospectively randomized 3,687 patients with up to 3 noncomplex previously untreated native coronary artery lesions to EES versus PES at 66 U.S. sites. Follow-up through 2 years is complete in 3,578 patents (97.0%). RESULTS: Treatment with EES compared with PES reduced the 2-year rates of TLF (6.9% vs. 9.9%, p = 0.003), all MI (2.5% vs. 3.9%, p = 0.02), Q-wave MI (0.1% vs. 0.8%, p = 0.002), stent thrombosis (0.4% vs. 1.2%, p = 0.008), and ischemia-driven TLR (4.5% vs. 6.9%, p = 0.004), with nonsignificantly different rates of all-cause and cardiac mortality. Between 1 year and 2 years, there were no significant differences in adverse event rates between the 2 stent types. CONCLUSIONS: In the large-scale, prospective, multicenter, randomized SPIRIT IV trial, the benefits of EES compared with those of PES present at 1 year were sustained at 2 years.

Rotational vs. standard coronary angiography: an image content analysis.

OBJECTIVE: To evaluate the clinical utility of images acquired from rotational coronary angiographic (RA) acquisitions compared to standard "fixed" coronary angiography (SA). BACKGROUND: RA is a novel angiographic modality that has been enabled by new gantry systems that allow calibrated automatic angiographic rotations and has been shown to reduce radiation and contrast exposure compared to SA. RA provides a dynamic multiple-angle perspective of the coronaries during a single contrast injection. METHODS: The screening adequacy, lesion assessment, and a quantitative coronary analysis (QCA) of both SA and RA were compared by independent blinded review in 100 patients with coronary artery disease (CAD). RESULTS: SA and RA recognize a similar total number of lesions (P = 0.61). The qualitative assessment of lesion characteristics and severity between modalities was comparable and lead to similar clinical decisions. Visualization of several vessel segments (diagonal, distal RCA, postero-lateral branches and posterior-descending) was superior with RA when compared to SA (P < 0.05). A QCA comparison (MLD, MLA, LL, % DS) revealed no difference between SA and RA. The volume of contrast (23.5 +/- 3.1 mL vs. 39.4 +/- 4.1; P = 0.0001), total radiation exposure (27.1 +/- 4 vs. 32.1 +/- 3.8 Gycm(2); P = 0.002) and image acquisition time (54.3 +/- 36.8 vs. 77.67 +/- 49.64 sec; P = 0.003) all favored RA. CONCLUSION: Coronary lesion assessment, coronary screening adequacy, and QCA evaluations are comparable in SA and RA acquisition modalities in the diagnosis of CAD however RA decreases contrast volume, image acquisition time, and radiation exposure.

Randomized study of the safety and clinical utility of rotational angiography versus standard angiography in the diagnosis of coronary artery disease.

This study evaluates the safety and clinical utility of rotational angiography in the diagnosis of coronary artery disease. High-speed rotational angiography is a newly available angiographic modality that gives a dynamic multiple-angle perspective of the coronary tree during a single contrast injection. We prospectively randomized 56 patients referred for diagnostic coronary angiography to either standard or rotational angiography. Contrast and radiation utilization were compared between the two groups. The number of additional cine acquisitions needed was used to determine adequacy of the diagnostic study protocol. Rotational angiography was successfully completed in all subjects. There was a 33% reduction in contrast utilization in the rotational group as compared to the standard group (35.6 +/- 12.6 vs. 52.8 +/- 10.7 ml, respectively; P < 0.0001). Additionally, there was a 28% reduction in total radiation exposure in the rotational group as compared to the standard group (39.0 +/- 18.5 vs. 53.9 +/- 23.4 Gycm(2), respectively; P = 0.01). Total whole-body radiation exposure to the primary operator was 144 mrem with rotational angiography and 170 mrem with standard angiography. Procedure time tended to be shorter for rotational angiography (353.9 +/- 146.7 vs. 396.8 +/- 165.8 s; P = 0.3). Rotational coronary angiography can be rapidly performed in any patient and provides a significant reduction in contrast and radiation utilization while at the same time providing adequate angiographic data to complement or replace standard coronary angiography in the evaluation of coronary artery disease.

Coronary Angioplasty.

Percutaneous revascularization is a widely accepted procedure to treat patients with coronary artery disease. Since its first description in the 1970s, significant technological and pharmaceutical advances have occurred and subsequently reduced the complications associated with the procedure. Large, randomized controlled trials have provided additional evidence that percutaneous revascularization improves morbidity and mortality in patients with coronary artery disease. Over the last decade, devices designed to treat patients with more complex coronary artery disease have expanded the available therapeutic options and will likely contribute to a further decline in adverse events. Despite these advances, the management of patients with acute myocardial infarction, in-stent restenosis, and multivessel coronary artery disease remains challenging. The majority of evidence supports an early, aggressive approach in patients with acute ST-elevation and non-ST-elevation myocardial infarction. Ongoing clinical trials should help to further define the role of percutaneous interventions in the optimal management of patients with coronary artery disease.

Optimal deployment of third-generation stents: an intravascular ultrasound assessment.

Third-generation intracoronary stents allow deployment at higher pressures, possibly obviating the need for high-pressure postdilations and also possibly reducing restenosis. This study evaluated the ability of the Tristar Coronary Stent System to produce optimal stent deployment as measured by intravascular ultrasound (IVUS) and quantitative coronary angiography in 46 patients. Optimal stent deployment was defined as minimal luminal area > 80% of the average of the proximal and distal reference luminal areas. After initial deployment, 74.5% of stents met criteria for optimal stent deployment by IVUS, with an average stent expansion ratio of 89.6%. Ten stents (18.2%) were postdilated. Four patients (8.7%) had a major adverse cardiac event, one patient died, one patient had a myocardial infarction, and two patients had target vessel revascularization at 6 months. The Tristar stent system produces optimal deployment without the need for routine postdilation and results in optimal clinical outcomes.