Percutaneous left atrial appendage closure with the Watchman device: a systematic review.

Atrial fibrillation (AF) is the most commonly observed arrhythmia in the world and its prevalence increases with age. The main and most severe complication of AF is ischemic stroke. Oral anticoagulation (OAC) therapy is the standard of care for stroke prevention in the high risk population. Initiation of this treatment is associated with a substantial risk of bleeding complications. Moreover, there is a group of patients who cannot tolerate OAC. In patients with AF the left atrial appendage (LAA) is the main source of thrombus formation. Percutaneous left atrial appendage closure (LAAC) has become an important non-pharmacological intervention for stroke prevention in patients with non-valvular AF. The procedure aims to reduce the risk of thromboembolism without increasing the risk of bleeding. Over the last few years, the safety and long-term efficacy of the procedure in specific populations have increased and more patients are being treated. The Watchman device is the most studied device in this field. Randomized controlled trials demonstrated non-inferiority of percutaneous left atrial appendage closure using the WATCHMAN 2.5 device to OAC (Boston Scientific, Marlborough, MA, USA). The new generation device, WATCHMAN FLX, was introduced and its use was associated with fewer safety events and a higher success rate of effective appendage closure. Nevertheless, several unsolved problems remain, including device-related thrombosis, the post-LAAC antithrombotic regimen, and peri-device leakage. This review will focus on LAAC with the Watchman device for stroke prevention in AF patients. Current status, available literature, clinical safety and efficacy will be summarized.

Safety and efficacy of percutaneous atrial appendage closure followed by antiplatelet therapy in a high-risk population: single-center experience with a WATCHMAN device.

Introduction: In our everyday practice we encounter many patients with non-valvular atrial fibrillation with either a contraindication to oral anticoagulation or with its inefficiency. Aim: To investigate whether left atrial appendage closure (LAAC) followed by post-procedure antiplatelet therapy is safe and efficient in a high-risk population. Material and methods: Ninety-one (48 males) consecutive patients with non-valvular atrial fibrillation (NVAF) underwent an LAAC procedure using a first-generation WATCHMAN 2.5 device followed by antiplatelet therapy. Clinical and transesophageal echocardiography data were collected at baseline and at the follow-up visit. Results: The median (IQR) CHA2DS2-VASc score was 5 (4.0-6.0) and the HAS-BLED score was 3 (3.0-4.0); the mean (SD) age was 74.4 (8.4). A bleeding history was observed in 89% of patients and 24.2% of patients had a history of stroke or transient ischemic attack (TIA). The procedure was successful in 98.9%. Post-procedure therapy was dual antiplatelet therapy in 85 patients; 3 patients received single antiplatelet therapy and the therapy was maintained until the follow-up visit. Peri-procedural complications were tamponade (3.3%), pericardial effusion (2.2%) and two deaths (2.2%) with no bleeding or vascular complications. The median follow-up was 67 (52.75-84.75) days. Primary safety endpoint (bleeding BARC type 3 or more, tamponade, pericardial effusion, and device embolization) and primary efficacy endpoint (stroke or TIA, hemorrhagic stroke, peripheral embolism, cardiovascular (CV) and non-CV death) were observed in 2 and 4 patients, respectively. Conclusions: The LAAC procedure followed by antiplatelet therapy seems to be safe and efficient in the high-risk population. Further studies in this field are required.

Optimal Management of Patients with Severe Coronary Artery Disease following Multidisciplinary Heart Team Approach-Insights from Tertiary Cardiovascular Care Center.

Background: The purpose of this retrospective study was to investigate outcomes of patients with severe coronary artery disease (CAD) after implementing various treatment strategies following multidisciplinary Heart Team (MHT) discussion. Methods Primary and secondary endpoints and quality of life during a mean (SD) follow-up of 37 (14) months of patients with severe CAD (three-vessel [3-VD] or/and left main [LM] disease) qualified after MHT discussion to optimal medical treatment (OMT) alone, OMT and coronary artery bypass grafting (CABG), or OMT and percutaneous coronary intervention (PCI) were evaluated. As the primary endpoint, major adverse cardiac or cerebrovascular events (MACCE) (i.e., death from any cause, stroke, myocardial infarction, or repeat/need for revascularization) were considered. Result: From 2016 to 2019, 176 MHT meetings were held, and a total of 1286 participants with severe CAD and completely implemented MHT decisions (OMT, CABG, or PCI for 251, 356, and 679 patients, respectively) were included. The occurrence of the primary endpoint was significantly increased in OMT-group (154 (61.4%) vs. CABG and PCI groups­110 (30.9%) and 302 (44.5%) patients, respectively (p < 0.05). For interventional strategies only­CABG was associated with reduced rates of MACCE and repeat revascularization, while the superiority of PCI for stroke and disabling stroke was observed (p < 0.05). The general health status assessed at the end of the follow-up was significantly better for patients who underwent CABG or PCI than in the OMT group (p < 0.05). Conclusions: In this real-life study, we presented a single-center experience of providing optimal medical care for patients with severe CAD following MHT discussion.

Optimal medical therapy in patients with stable coronary artery disease in Poland: the ISCHEMIA trial experience.

Introduction: Optimal medical therapy (OMT) is the cornerstone of treatment for stable coronary disease with the ISCHEMIA trial showing similar outcomes using OMT with or without an initial invasive approach. Objectives: To describe OMT goal attainment in Polish ISCHEMIA participants compared with other countries. Patients and methods: Among 5179 trial participants, 333 were randomized in Poland. The median follow-up was 3.2 years. OMT targets were: not smoking, high-intensity statin therapy, low-density lipoprotein cholesterol (LDL-C) of less than 70 mg/dl, systolic blood pressure of less than 140 mm Hg, aspirin therapy, and ACEI / ARB, and ß-blocker therapy if indicated. Results: Compared with 36 other countries, at randomization, patients in Poland were older (67 [62­75] y vs 65 [58­71] y); P <⁠0.001), more often female (30% vs 22%; P = 0.002), with a longer history of angina (3 [1­9] y vs 1 [0­3] y; P <⁠0.001), and there were more cases of prior myocardial infarction (32% vs 18%; P <⁠0.01) and revascularization (PCI, 40% vs 19%; CABG, 11% vs 3%; P <⁠0.001 for both). The number of OMT goals attained increased from baseline to follow-up visits (5 [4­5] vs 6 [5­6]; P <⁠0.001) in Poland and other countries alike (P = 0.89 vs P = 0.14). In Poland, significant improvements were achieved regarding high-intensity statin therapy (27% vs 50%), LDL-C <⁠70 mg/dl (29% vs 65%), and systolic blood pressure of less than 140 mm Hg (63% vs 81%) (P <⁠0.001 for all), whereas not-smoking (89% vs 89%), aspirin (90% vs 88%), ACEI / ARB (93% vs 95%), and ß-blocker therapy (94% vs 90%) remained high. Conclusions: With regular surveillance and contemporary medical therapy, high OMT goal attainment was achievable among the participants of the ISCHEMIA trial in Poland relative to other countries. There is still room for improvement in LDL-C and blood pressure management.

Serial Baseline, 12-, 24-, and 60-Month Optical Coherence Tomography Evaluation of ST Segment Elevation Myocardial Infarction Patients Treated with Absorb Bioresorbable Vascular Scaffold.

Data on long-term neointimal healing and neoatherosclerosis progression after primary percutaneous coronary intervention (PCI) with implantation of everolimus-eluting bioresorbable vascular scaffold (BVS) (ABSORB BVS 1.0, Abbott Vascular) are limited. The mechanisms underlying very late scaffold failure remain to be further elucidated. This study sought to assess healing pattern and presence of neoatherosclerosis. This was a single-center, prospective, longitudinal study with serial optical coherence tomography (OCT) assessment at baseline, 12, 24 and 60 months after PCI performed in 12 patients presenting with ST-segment elevation myocardial infarction (STEMI). The median follow-up was 59 months. The diameter stenosis increased from 7.11 ± 4.99% at 1-year to 21.00 ± 11.31% at 5 years, (p = 0.03), whereas minimum lumen diameter remained stable throughout the follow-up period, as assessed by angiography. Minimum and mean lumen area declined over the 5-year follow-up by 1.00 ± 1.57 mm2 and 1.75 ± 0.87 mm2, respectively; a significant decrease in minimum and mean lumen area in the first two years, was followed by stable luminal dimensions between 2 and 5 years of follow-up. The lumen eccentricity (0.85 ± 0.03) and asymmetry (0.43 ± 0.10) indexes showed no change over 60-month follow-up. The incidence of atherosclerosis was high both in the in-scaffold (IS) and out-scaffold (OS) regions consisting of calcifications (IS = 100%, OS = 92%, p = 0.99), macrophages (IS = 92% and OS = 67%, p = 0.31), neovascularization (IS = 75%, OS = 50%, p = 0.40). In conclusion, serial OCT imaging up to 5 years after implantation of BVS in STEMI indicated complete scaffold resorption, stable lumen area following period of neointima growth in the first two years after PCI and high incidence of neoatherosclerosis.

OCT-Derived Plaque Morphology and FFR-Determined Hemodynamic Relevance in Intermediate Coronary Stenoses.

BACKGROUND: optical coherence tomography (OCT) might allow identifying lesion features reportedly associated with plaque vulnerability and increased risk of clinical events. Previous studies on correlation between OCT and functional lesion significance indices reported contradictory results, yet integration of complementary information from both modalities is gaining increased interest. The aim of the study was to compare plaque morphology using OCT in hemodynamically relevant vs. non-relevant lesions by fractional flow reserve (FFR). METHODS: consecutive patients with intermediate grade coronary stenoses by angiography were evaluated by both FFR and OCT in this single-center study. Stenoses were labeled hemodynamically relevant in case of the FFR ≤ 0.80. Minimal lumen area (MLA), fibrous cap thickness (FCT), minimal cap thickness over the calcium, angle of the calcium, and necrotic core within the lesions were evaluated. RESULTS: a total of 105 patients (124 vessels) were analyzed. Of them, 65 patients were identified with at least one lesion identified as hemodynamically relevant by FFR (72 vessels, 58.1%). Lesions with FFR ≤0.80 presented with lower mean and minimal lumen area (3.46 ± 1.29 vs. 4.65 ± 2.19, p =0.001 and 1.84 ± 0.97 vs. 2.66 ± 1.40, p = 0.001) compared to patients with FFR > 0.80. No differences were found between groups in the mean and minimal FCT, mean, and maximal necrotic core, calcium angle, as well as the overall rate of calcified and lipid plaques. CONCLUSION: hemodynamic relevance of intermediate grade lesions correlated moderately with the luminal assessment by OCT. No differences were identified in the plaque morphology between relevant and non-relevant coronary stenoses by FFR.

Kardia Mobile applicability in clinical practice: A comparison of Kardia Mobile and standard 12-lead electrocardiogram records in 100 consecutive patients of a tertiary cardiovascular care center.

BACKGROUND: Mobile devices are gaining a rising number of users in all countries around the globe. Novel solutions to diagnose patients with out-of-hospital onset of arrhythmic symptoms can be easily used to record such events, but the effectiveness of these devices remain unknown. METHODS: In a group of 100 consecutive patients of an academic cardiology care center (mean age 68 ± 14.2 years, males: 66%) a standard 12-lead electrocardiogram (ECG) and a Kardia Mobile (KM) record were registered. Both versions were assessed by three independant groups of physicians. RESULTS: The analysis of comparisons for standard ECG and KM records showed that the latter is of lower quality (p < 0.001). It was non-inferior for detection of atrial fibrillation and atrial flutter, showed weaker rhythm detection in pacemaker stimulation (p = 0.008), and was superior in sinus rhythm detection (p = 0.02), though. The sensitivity of KM to detect pathological Q-wave was low compared to specificity (20.6% vs. 93.7%, respectively, p < 0.001). Basic intervals measured by the KM device, namely PQ, RR, and QT were significantly different (shorter) than those observed in the standard ECG method (160 ms vs. 180 ms [p < 0.001], 853 ms vs. 880 ms [p = 0.03] and 393 ms vs. 400 ms [p < 0.001], respectively). CONCLUSIONS: Initial and indicative value of atrial fibrillation and atrial flutter detection in KM is comparable to results achieved in standard ECG. KM was superior in detection of sinus rhythm than eye-ball evaluation of 12-lead ECG. Though, the PQ and QT intervals were shorter in KM as compared to 12-lead ECG. Clinical value needs to be verified in large studies, though.

Second generation, sirolimus-eluting, bioresorbable Tyrocore scaffold implantation in patients with ST-segment elevation myocardial infarction: Baseline OCT and 30-day clinical outcomes - A FANTOM STEMI pilot study.

BACKGROUND: There is paucity of data on acute performance of Fantom (REVA Medical, CA), a second generation sirolimus-eluting bioresorbable scaffold (BRS), in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention. The aim of this study was to evaluate safety and efficacy of the Fantom BRS in the acute setting of STEMI characterized by thrombogenic milieu. METHODOLOGY: Ten STEMI patients treated with a sirolimus-eluting Fantom BRS were enrolled into prospective, observational study. The scaffold sizing, positioning, and optimization were optical coherence tomography (OCT) guided. The primary end-point was the device-oriented composite endpoint (DOCE), additionally angiographic and OCT analysis were performed. RESULTS: The primary-end point, defined as DOCE, did not occur in any patient within the 30-day follow-up. The procedural and angiographic success rates were both 100%, there was no case of scaffold thrombosis, target lesion revascularization nor death. In QCA, an in-device minimum lumen diameter was 2.89 ± 0.24 mm and the residual diameter stenosis was 3.56 ± 3.17%. OCT revealed an incomplete scaffold apposition in five patients with an average of seven malapposed struts per scaffold and mean distance of 120 ± 30 µm. There was no proximal edge dissection, the distal edge dissection was recorded in one patient. CONCLUSIONS: This is the first pilot study evaluating safety and efficacy of the Fantom BRS, a second generation fully bioresorbable coronary scaffold, in STEMI patients undergoing primary PCI with OCT guidance. Fantom BRS showed adequate safety and efficacy in the acute 30-day angiographic, OCT, and clinical follow-up.

Alternative methods for functional assessment of intermediate coronary lesions.

Wire-based fractional flow reserve (FFR) is a diagnostic tool used to evaluate the ischemic burden of coronary lesions. Large-scale studies have shown that FFR-guided revascularization is associated with better clinical outcomes. However, wide adoption of this technology is limited due to the considerable cost, additional time needed for set-up and performance of the measurement as well as the invasiveness of the procedure which requires pressure wire placement across the lesion into the distal segment of the coronary artery. To overcome these limitations new, promising, and less-/non-invasive methods were developed. These methods are based on computational fluid dynamics analysis and three-dimensional lumen reconstruction. The aim of this paper is to review scientific evidence supporting the clinical safety and efficacy of these techniques, such as instantaneous wave-free ratio, quantitative flow ratio and FFR calculated from computed tomographic angiography.

Quantitative flow ratio and fractional flow reserve mismatch - clinical and biochemical predictors of measurement discrepancy.

INTRODUCTION: Fractional flow reserve (FFR) is the gold standard for functional assessment of intermediate lesions. However, assessing a stenosis with pressure wire prolongs the procedure, increases costs and carries a risk of procedure-related adverse events. Quantitative flow ratio (QFR) is a wire-free method for detection of significant ischemia based on 3D reconstruction of angiographic images and TIMI frame count. AIM: To evaluate the influence of laboratory and clinical variables on QFR-FFR mismatch. MATERIAL AND METHODS: We retrospectively computed QFR (Medis Suite XA/QAngio XA 3D/QFR, Medis/Netherlands) in suitable cases with corresponding FFR (PressureWire, Abbott, US). Uni-/multivariate analysis was performed to identify clinical and biochemical predictors of QFR-FFR mismatch. RESULTS: Two hundred six lesions (196 patients, 76% male, mean age: 66.4 ±10.1 years) were included. Chronic kidney disease (CKD) and insulin-treated diabetes mellitus (ITDM) were associated with significantly larger differences between QFR and FFR values (-0.062 ±0.031 vs. -0.025 ±0.068; p = 0.027 and -0.059 ±0.07 vs. -0.027 ±0.074; p = 0.039; respectively). CKD was associated with a decrease of diagnostic efficiency (AUC = 0.67, 95% CI: 0.46-0.88 vs. AUC = 0.89, 95% CI: 0.84-0.94, p = 0.05). For biochemical variables only weak Spearman correlations were identified for hemoglobin concentration (r = -0.18) and hematocrit levels (r = -0.18). CONCLUSIONS: CKD may impair the QFR diagnostic accuracy. Larger, prospective studies are needed to further explore this potential relationship.

Association of galectin-3 and soluble ST2 with in-hospital and 1-year outcomes in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention.

INTRODUCTION: Galectin­3 (Gal­3) and soluble interleukin-1 receptor-like 1 (sST2) have known prognostic value in already diagnosed heart failure (HF). OBJECTIVES: To investigate the association of Gal­3 and sST2 with prognosis in patients with ST­segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI). PATIENTS AND METHODS: The analysis was based on data collected in a prospective observational BIOSTRAT (Biomarkers for Risk Stratification After STEMI; ClinicalTrials.gov identifier, NCT03735719) study. Analysis included 117 patients with first­time STEMI treated with pPCI. Serum for Gal­3 and sST2 was sampled 72 to 96 hours after admission due to STEMI. The patients were followed for the primary endpoint (cardiovascular [CV] death or HF hospitalization at 1 year). RESULTS: Both biomarkers correlated with N­terminal pro­B­type natriuretic peptide (NT­proBNP); Gal­3 correlated with older age. Data on the primary endpoint were available for 104 patients (89%). At 1­year follow­up, 9 patients (8.7%) reached the primary endpoint. In univariate Cox proportional hazards regression analysis, both Gal­3 and sST2 as continuous variables, as well as their newly­established cutoffs (≥9.57 ng/ml for Gal­3 and ≥45.99 ng/ml for sST2, based on the Youden index) were predictors of the primary endpoint, and of HF hospitalizations alone. Gal­3 also predicted CV death. After adjustment for age and NT­proBNP, Gal­3 and sST2 remained predictors of the primary endpoint in multivariate models. CONCLUSIONS: In patients with first­time STEMI treated with pPCI, baseline Gal­3 and sST2 predicted the composite of CV death and HF hospitalization at 1 year. Both biomarkers may play an important role in CV risk stratification after STEMI, although Gal­3 may be considered preferable.

Quantitative flow ratio derived from diagnostic coronary angiography in assessment of patients with intermediate coronary stenosis: a wire-free fractional flow reserve study.

AIMS: To evaluate diagnostic accuracy of quantitative flow ratio (QFR). A novel method was used for non-invasive functional assessment of intermediate coronary lesions. Fractional flow reserve (FFR) is the gold standard for functional assessment of intermediate lesions. However, interrogating a stenosis with pressure wire prolongs the procedure, increases costs and carries a risk of procedure-related adverse events. QFR is a wire-free method for computation of FFR based on 3D reconstruction of angiographic images and modified TIMI frame count. METHODS AND RESULTS: We retrospectively computed QFR (Medis Suite XA/QAngio XA 3D/QFR, Medis/Netherlands) in suitable cases with corresponding FFR (PressureWire™, Abbott, US/). Four QFR measures were tested against FFR: (1) fixed-flow QFR (fQFR), (2) vessel QFR (vQFR), (3) lesion QFR (lQFR) and (4) index QFR (iQFR). 857 lesions (740 patients) were reviewed, 306 (268 patients) met technical inclusion criteria for QFR (two optimal angiographic projections > 25° apart; no ostial location, no overlapping/shortening, frame-rate ≥ 15 fps). Mean angiographic percentage diameter stenosis was 51.3 ± 10.18%. Wire-based FFR ≤ 0.80 was found in 130 lesions (42.5%). Strong Pearson correlation was identified for iQFR (r = 0.85), fQFR (r = 0.73), vQFR (r = 0.78) and lQFR (r = 0.70). The optimal QFR decision values corresponding to FFR = 0.80 were iQFR = 0.79 (AUC = 0.94), fQFR = 0.73 (AUC = 0.87), vQFR = 0.77 (AUC = 0.90), and lQFR = 0.83 (AUC = 0.82). Sensitivity and specificity > 95% were identified for iQFR ≤ 0.74 (n = 89, 29%) and > 0.83 (n = 116, 38%), respectively. CONCLUSIONS: The QFR value at the pressure transducer position (iQFR) was the best corresponding QFR model. iQFR is characterised by high diagnostic accuracy and used in a hybrid model with FFR which may reduce the number of procedures requiring pressure-wire by two-thirds.

Dual antiplatelet therapy is safe and efficient after left atrial appendage closure.

BACKGROUND: Despite results of the PROTECT AF trial, many patients undergoing left atrial appendage closure (LAAC) have unconditional contraindications to warfarin. AIM: We sought to investigate whether double antiplatelet therapy (DAPT) is safe in patients after LAAC. METHODS: Forty-four consecutive patients (22 males, mean age 74 ± 7.8 years) with non-valvular atrial fibrillation (NVAF) underwent LAAC procedure using a Watchman device followed by DAPT (75 mg/d aspirin and 75 mg/d clopidogrel). After the procedure and during 98 days' follow-up including transoesophageal echocardiography, peri-procedural complications and clinical outcomes were investigated. RESULTS: Mean CHA2DS2-VASc score was 4.9 ± 1.5 and mean HAS-BLED score was 3.6 ± 0.8. The main LAAC indication was contraindication to anticoagulation reflected by HAS-BLED score ≥ 3 observed in 95.5% cases (among them history of bleeding in 38 patients, 90.5%). 36.4% of patients have history of stroke or transient ischaemic attack. The procedure was successful in 97.7%. Peri-procedural complications were tamponade (2.3%) and one death (2.3%) unrelated to the procedure with no bleeding or vascular complications. During follow-up neither stroke nor bleeding were observed, whereas two device related thrombi and two unrelated deaths occurred. CONCLUSIONS: LAAC followed by DAPT seems to be a safe and efficient alternative for stroke prevention in patients with NVAF who have contraindications to anticoagulation therapy. This strategy may provide a significant reduction of events such as stroke and bleeding versus the score-predicted rate.