Embolization of percutaneous left atrial appendage closure devices: Timing, management and clinical outcomes.

BACKGROUND: Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication. OBJECTIVES: We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry. METHODS: Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. RESULTS: Sixty-seven centers contributed data. Device embolization occurred in 108 patients. In 70.4 % of cases, it happened within the first 24 h of the procedure. The device was purposefully left in the LA and the aorta in two (1.9 %) patients, an initial percutaneous retrieval was attempted in 81 (75.0 %) and surgery without prior percutaneous retrieval attempt was performed in 23 (21.3 %) patients. Two patients died before a retrieval attempt could be made. In 28/81 (34.6 %) patients with an initial percutaneous retrieval attempt a second, additional attempt was performed, which was associated with a high mortality (death in patients with one attempt: 2.9 % vs. second attempt: 21.4 %, p < 0.001). The primary outcome (bailout surgery, cardiogenic shock, stroke, TIA, and/or death) occurred in 47 (43.5 %) patients. Other major complications related to device embolization occurred in 21 (19.4 %) patients. CONCLUSIONS: The majority of device embolizations after LAA closure occurs early. A percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was unsuccessful. CONDENSED ABSTRACT: This dedicated multicenter registry examined timing, management, and clinical outcome of device embolization. Early embolization (70.4 %) was most frequent. As a first rescue attempt, percutaneous retrieval was preferred in 75.0 %, followed by surgical removal (21.3 %). In patients with a second retrieval attempt a higher mortality (death first attempt: 2.9 % vs. death second attempt: 24.1 %, p < 0.001) was observed. Mortality (10.2 %) and the major complication rate after device embolization were high.

Perioperative Antiplatelet Strategy in Patients Undergoing Noncardiac Surgery Within One Year After Percutaneous Coronary Intervention.

BACKGROUND: The optimal antiplatelet therapy (APT) for patients undergoing non-cardiac surgery within 1 year after percutaneous coronary intervention (PCI) is not yet established. METHODS: Patients who underwent non-cardiac surgery within 1 year after second-generation drug-eluting stent implantation were included from a multicenter prospective registry in Korea. The primary endpoint was 30-day net adverse clinical event (NACE), including all-cause death, major adverse cardiovascular event (MACE), and major bleeding events. Covariate adjustment using propensity score was performed. RESULTS: Among 1130 eligible patients, 708 (62.7%) continued APT during non-cardiac surgery. After propensity score adjustment, APT continuation was associated with a lower incidence of NACE (3.7% vs 5.5%; adjusted odds ratio [OR], 0.48; 95% confidence interval [CI], 0.26-0.89; P = .019) and MACE (1.1% vs 1.9%; adjusted OR, 0.35; 95% CI, 0.12-0.99; P = .046), whereas the incidence of major bleeding events was not different between the 2 APT strategies (1.7% vs 2.6%; adjusted OR, 0.61; 95% CI, 0.25-1.50; P = .273). CONCLUSIONS: The APT continuation strategy was chosen in a substantial proportion of patients and was associated with the benefit of potentially reducing 30-day NACE and MACE with similar incidence of major bleeding events, compared with APT discontinuation. This study suggests a possible benefit of APT continuation in non-cardiac surgery within 1 year of second-generation drug-eluting stent implantation.

Feasibility and Safety of the Left Distal Radial Approach in Percutaneous Coronary Intervention for Bifurcation Lesions.

Recently, the left distal radial approach (DRA) for percutaneous coronary intervention (PCI) has been shown to be a feasible option, but there are limited data regarding the feasibility of performing bifurcation PCI via the left DRA. Therefore, this study aimed to describe our experience with the contemporary left DRA to perform PCI of bifurcation lesions. Between December 2017 and December 2019, we identified 106 patients treated with bifurcation PCI via the left DRA. We evaluated the success rate of PCI, access-site complications including major bleeding requiring surgery or transfusion, hematoma, distal and forearm radial artery occlusion, and 30-day mortality. Eleven patients (10.4%) treated with left main bifurcation and true bifurcations accounted for 39.6% of cases, with the left anterior descending artery/diagonal branch being the most frequent bifurcation site (57.5%, 61/106). PCI was performed using a 6-French guiding catheter in 101 (95.3%) cases. Successful PCI for bifurcation lesions via the left DRA was achieved in all 106 patients without access-site cross-over. There was no major bleeding, distal and forearm radial artery occlusion, forearm hematoma, or mortality at 30 days. The left DRA is a safe and feasible alternative access site for bifurcation PCI in selected patients.

Consensus Decision-Making for the Management of Antiplatelet Therapy before Non-Cardiac Surgery in Patients Who Underwent Percutaneous Coronary Intervention With Second-Generation Drug-Eluting Stents: A Cohort Study.

Background Although antiplatelet therapy (APT) has been recommended to balance ischemic-bleeding risks, it has been left to an individualized decision-making based on physicians' perspectives before non-cardiac surgery. The study aimed to assess the advantages of a consensus among physicians, surgeons, and anesthesiologists on continuation and regimen of preoperative APT in patients with coronary drug-eluting stents. Methods and Results A total of 3582 adult patients undergoing non-cardiac surgery after percutaneous coronary intervention with second-generation stents was retrospectively included from a multicenter cohort. Physicians determined whether APT should be continued or discontinued for a recommended period before non-cardiac surgery. There were 3103 patients who complied with a consensus decision. Arbitrary APT, not based on a consensus decision, was associated with urgent surgery, high bleeding risk of surgery, female sex, and dual APT at the time of preoperative evaluation. Arbitrary APT independently increased the net clinical adverse event (adjusted odds ratio [ORadj], 1.98; 95% CI, 1.98-3.11), major adverse cardiac event (ORadj, 3.11; 95% CI, 1.31-7.34), and major bleeding (ORadj, 2.34; 95% CI, 1.45-3.76) risks. The association was consistently noted, irrespective of the surgical risks, recommendations, and practice on discontinuation of APT. Conclusions Most patients were treated in agreement with a consensus decision about preoperative APT based on a referral system among physicians, surgeons, and anesthesiologists. The risk of perioperative adverse events increased if complying with a consensus decision was failed. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03908463.

Patterns of Antiplatelet Therapy During Noncardiac Surgery in Patients With Second-Generation Drug-Eluting Stents.

Background Continuing antiplatelet therapy (APT) has been generally recommended during noncardiac surgery, but it is uncertain if preoperative discontinuation of APT has been avoided or harmful in patients with second-generation drug-eluting coronary stents. Methods and Results Patients undergoing noncardiac surgery after second-generation drug-eluting coronary stent implantation were assessed in a multicenter cohort in Korea. Net adverse clinical events within 30 days postoperatively, defined as all-cause death, major adverse cardiac events, and major bleeding, were evaluated. Of 3582 eligible patients, 49% patients discontinued APT during noncardiac surgery. The incidence of net adverse clinical events was comparable between patients with continuation versus discontinuation (4.1% versus 3.4%; P=0.257) of APT during noncardiac surgery. Perioperative discontinuation of APT did not impact on net adverse clinical events (adjusted hazard ratio [HR], 1.00; 95% CI, 0.69-1.44; P=0.995). In subgroup analysis, patients undergoing intra-abdominal surgery were exposed to less risk of major bleeding by discontinuing APT (adjusted HR, 0.26; 95% CI, 0.08-0.91; P=0.035). Prolonged discontinuation of APT for ≥9 days was associated with higher risk of a major adverse cardiac event compared with continuing APT (adjusted HR, 3.38; 95% CI, 1.36-8.38; P=0.009). Conclusions APT was discontinued preoperatively in almost half of patients with second-generation drug-eluting coronary stents. Our explorative analysis showed that there was no significant impact of discontinuing APT on the risk of perioperative adverse events except that discontinuing APT may be associated with decreased hemorrhagic risk in patients undergoing intra-abdominal surgery. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT03908463.

Anti-Inflammatory Effect for Atherosclerosis Progression by Sodium-Glucose Cotransporter 2 (SGLT-2) Inhibitor in a Normoglycemic Rabbit Model.

BACKGROUND AND OBJECTIVES: We sought to investigate an anti-atherosclerotic and anti-inflammatory effect of sodium-glucose cotransporter-2 (SGLT-2) inhibitors in normoglycemic atherosclerotic rabbit model. METHODS: Male New Zealand white rabbits (n=26) were fed with a 1% high-cholesterol diet for 7 weeks followed by normal diet for 2 weeks. After balloon catheter injury, the rabbits were administered with the Dapagliflozin (1mg/kg/day) or control-medium for 8 weeks (n=13 for each group). All lesions were assessed with angiography, optical coherence tomography (OCT), and histological assessment. RESULTS: Atheroma burden (38.51±3.16% vs. 21.91±1.22%, p<0.01) and lipid accumulation (18.90±3.63% vs. 10.20±2.03%, p=0.047) was significantly decreased by SGLT-2 inhibitor treatment. The SGLT-2 inhibitor group showed lower macrophage infiltration (20.23±1.89% vs. 12.72±1.95%, p=0.01) as well as tumor necrosis factor (TNF)-α expression (31.17±4.40% vs. 19.47±2.10%, p=0.025). Relative area of inducible nitric oxide synthase⁺ macrophages was tended to be lower in the SGLT-2 inhibitor-treated group (1.00±0.16% vs. 0.71±0.10%, p=0.13), while relative proportion of Arg1⁺ macrophage was markedly increased (1.00±0.27% vs. 2.43±0.64%, p=0.04). As a result, progression of atherosclerosis was markedly attenuated in SGLT-2 inhibitor treated group (OCT area stenosis, 32.13±1.20% vs. 22.77±0.88%, p<0.01). Mechanistically, SGLT-2 treatment mitigated the inflammatory responses in macrophage. Especially, Toll-like receptor 4/nuclear factor-kappa B signaling pathway, and their downstream effectors such as interleukin-6 and TNF-α were markedly suppressed by SGLT-2 inhibitor treatment. CONCLUSIONS: These results together suggest that SGLT-2 inhibitor exerts an anti-atherosclerotic effect through favorable modulation of inflammatory response as well as macrophage characteristics in non-diabetic situation.

Synergistic protective effects of a statin and an angiotensin receptor blocker for initiation and progression of atherosclerosis.

AIM: Although the atheroprotective effects of statins and angiotensin II receptor blockers (ARBs) are well-established, little is known about their additive effects, especially during the early period of atherosclerosis. The aim of this study was to investigate whether combination of a statin and an ARB exerts synergistic anti-atherosclerotic effects, and to elucidate the mechanisms of combined effects. METHODS: Atherosclerotic plaques were developed in arteries of 23 rabbits using a high-cholesterol diet (HCD) and intra-arterial balloon inflation. Rabbits received one of five different treatment strategies for 4 weeks: positive control [n = 5, HCD]; negative control [n = 3, regular chow diet]; statin [n = 5, HCD and rosuvastatin 10 mg]; ARB [n = 5, HCD and olmesartan 20 mg]; and combination [n = 5, HCD and statin+ARB]. RESULTS: Histological analysis demonstrated that development of atherosclerotic plaques was inhibited more in combination group than in statin group (P = 0.001). Although macrophage infiltration identified by RAM11 staining was not significantly different between combination and individual treatment groups (31.76±4.84% [combination] vs. 38.11±6.53% [statin; P = 0.35] or 35.14±2.87% [ARB; P = 0.62]), the relative proportion of pro-inflammatory M1-macrophages was significantly lower in combination group than in ARB group (3.20±0.47% vs. 5.20±0.78%, P = 0.02). Furthermore, M2-macrophage polarization was higher in combination group than in statin group (17.70±3.04% vs. 7.86±0.68%, P = 0.001). CONCLUSION: Combination treatment with a statin and an ARB produced synergistic protective effects for atherosclerosis initiation and progression, which may be attributed to modulation of macrophage characteristics in the early period of atherosclerosis.

The Incidence of Non-Cardiac Surgery in Patients Treated With Drug-Eluting Stents According to Age.

OBJECTIVES: The impact of age on the incidence and timing of non-cardiac surgery after coronary stent implantation is unknown. We evaluated the incidence and timing of non-cardiac surgery after drug-eluting stent (DES) implantation according to patient age. METHODS: A total of 37,915 consecutive patients treated by DES implantation between February 2003 and April 2014 were included in this study. The number of patients who underwent non-cardiac surgery were as follows: 4263 (11.2%) within 1 year, 5357 (14.1%) within 2 years, and 6311 (16.6%) within 3 years of DES implantation. Patients were divided into four groups according to age: <50 years (n = 5785), between 50 and 59 years (n = 9639), between 60 and 69 years (n = 13,566), and between 70 and 79 years (n = 8925). RESULTS: The rates of non-cardiac surgery within 1 year among patients aged <50 years, 50-59 years, 60-69 years, and 70-79 years were 8.0% (461/5785), 8.9% (855/9639), 12.1% (1636/13,566), and 14.7% (1311/8925), respectively (P-value for trend <.01). The cut-off age at which non-cardiac surgery was more likely to occur within 1 year of DES implantation was 62 years. The rate of non-cardiac surgery within 3 years of DES implantation reached a peak among patients who were 73 years old (23.9%). CONCLUSIONS: Non-cardiac surgery with requests for cessation of dual-antiplatelet treatment was frequently performed in patients ≥62 years old who were treated with DES implantation in a real-world clinical practice.

Peripheral artery disease is associated with poor clinical outcome in patients with abdominal aortic aneurysm after endovascular aneurysm repair.

BACKGROUND: We investigated the effects of coronary artery disease (CAD) or peripheral artery disease (PAD) on clinical outcomes of patients with abdominal aortic aneurysm (AAA) treated with endovascular aortic aneurysm repair (EVAR). METHODS: We retrospectively evaluated a total of 475 patients with AAA treated with EVAR at a single center. Patients were divided into three groups: group A (n = 166), patients without CAD or PAD; group B (n = 196), patients with CAD but without PAD; and group C (n = 113), patients with PAD regardless of CAD. The primary endpoint was the accumulated rate of major adverse cardiovascular and cerebrovascular event (MACCE), a composite of all-cause death, myocardial infarction (MI), or stroke. RESULTS: The prevalence of CAD and PAD in patients with AAA was 55.8 and 23.8%, respectively. Patients were followed for 40.2 ±â€¯35.3 months. Baseline characteristics were similar among the groups except for current smoking (A, 27.4%; B, 20.8%; C, 50.5%; p = 0.001). Three years after EVAR, the incidences of MACCE (A, 5.6%; B, 9.5%; C, 16.7%; p = 0.021) and stroke (A, 0%; B, 2.2%; C, 5.2%; p = 0.025) were highest in group C. All-cause death and aneurysm death did not differ among the groups. PAD [hazard ratio (HR) 2.88, 95% confidence interval (CI) 1.32-6.29, p = 0.008] and previous stroke (HR 4.39, 95% CI 1.94-9.93, p < 0.001) were independent predictors of MACCE. CONCLUSIONS: PAD was an independent risk factor of increased MACCE and stroke for patients with AAA undergoing EVAR. More intensive secondary prevention may be needed to reduce adverse cardiovascular events in AAA patients with PAD.

Feasibility of Left Atrial Appendage Occlusion for Left Atrial Appendage Thrombus in Patients With Persistent Atrial Fibrillation.

This study sought to investigate the safety of percutaneous left atrial appendage (LAA) occlusion for stroke prevention in patients with nonvalvular atrial fibrillation who have LAA thrombus. From October 2010 to October 2016, LAA occlusions were performed in facilities within a Korean multicenter registry in patients without (n = 132) or with (n = 10) LAA thrombus (detected during preprocedural assessments). The incidences of periprocedural complications, including stroke, pericardial tamponade, major bleeding, and device embolization, were assessed and compared between the groups. The incidence of periprocedural complications was not significantly different between patients with and without LAA thrombus (0% vs 5% [6 of 132]; p = 0.49). During the mean 23.2 ± 17.5-month follow-up duration, 7 major adverse cardiac events occurred (1 cardiovascular death, 6 ischemic strokes), but overall event rates were not significantly different between the groups (14% vs 9%; p = 0.47). In conclusion, percutaneous LAA occlusion in nonvalvular atrial fibrillation patients with LAA thrombus may be a safe and feasible alternative to anticoagulation in select patients at a high risk of bleeding or contraindication to anticoagulation, or in whom anticoagulation failed to prevent stroke.

Successful Treatment of Unprotected Left Main Coronary Bifurcation Lesion Using Minimum Contrast Volume with Intravascular Ultrasound Guidance.

Contrast-induced nephropathy (CIN) is a serious complication in patients undergoing percutaneous coronary intervention (PCI), and is associated with higher morbidity and mortality. The limiting volume of contrast medium is safest and most reliable strategy for CIN prevention. Intravascular ultrasound (IVUS) serves as an attractive alternative imaging tool to angiography in many steps during PCI, thereby reducing the use of contrast agents. Here, we reported a case of successfully treated unprotected left main bifurcation lesion with heavily calcified and diffuse lesion under the IVUS-guided PCI using low volumes of contrast dye of total 12 cc in an elderly patient.

Transarterial chemoembolization versus surgery/radiofrequency ablation for recurrent hepatocellular carcinoma with or without microvascular invasion.

BACKGROUND/AIMS: Microvascular invasion (MVI) is a well-known prognostic factor of postoperative recurrence and of overall survival (OS) in patients with hepatocellular carcinoma (HCC). We compared the treatment outcomes of transarterial chemoembolization (TACE) and surgery/radiofrequency ablation (RFA) according to the presence of MVI in patients with early or late recurrent HCC that presented as Barcelona Clinical Liver Cancer (BCLC) stage 0 or A after curative resection for HCC. METHODS: A consecutive 68 patients with recurrent HCC of BCLC stage 0 or A at our institution between 1998 and 2012 were retrospectively enrolled. We compared the outcomes of patients treated by TACE or surgery/RFA. Tumor recurrence after curative resection was classified as early (≤ 12 months) or late (> 12 months) recurrence. RESULTS: Median tumor size was 1.5 cm (range, 1-10 cm), and 67 (98.5%) had HCCs within the Milan criteria. Median post-retreatment follow-up duration was 27 months (range, 1-109 months). Of the 68 patients, 19 (27.9%) underwent surgery/RFA, 47 (69.1%) TACE, and 2 (2.9%) were lost to follow-up. After retreatment, TACE showed significantly higher OS and recurrence-free survival rates than surgery/RFA in MVI-positive patients (P = 0.03 and P = 0.05, respectively), but not in MVI-negative patients (P = 0.95 and P = 0.98, respectively). In particular, in early recurred MVI-positive patients, TACE had a significantly higher OS rate than surgery/RFA (P = 0.01). CONCLUSIONS: TACE may be the more effective treatment option for recurrent HCC of BCLC stage 0 or A than surgery/RFA in MVI-positive patients, especially in those that recur early after curative resection.