The influence of implantation techniques on lesion oriented-outcomes in Absorb BVS and Xience EES lesions treated in routine clinical practice at complete three year follow-up: AIDA trial QCA substudy.

It has been hypothesized that dedicated optimized Absorb BVS implantation techniques might mitigate the risk of adverse events such as target vessel failure and device thrombosis. In this explorative AIDA trial QCA substudy, we sought to investigate the influence of implantation techniques on lesion-oriented outcomes in both the Absorb BVS and Xience EES arm at complete 3-year follow-up. The current analysis includes 2152 study lesions treated with at least one study device, of which the baseline angiogram was suited for offline QCA analysis, including Dmax analysis. The lesion-oriented composite outcome (LOCE) of this analysis was a composite of definite device thrombosis, target lesion revascularization and target-vessel myocardial infarction. In Absorb BVS, the Lesion-oriented composite endpoint (LOCE) occurred numerically less in correctly QCA sized vessels when compared to incorrectly sized vessels 8.5% (58/696) versus 11.1% (39/358), p = 0.151. In Xience EES, LOCE had occurred more frequently in incorrectly sized devices according to device diameter/RVD matching; 2.2% (4/187) in correctly sized devices versus 7.1% (63/911) in incorrectly sized devices (p = 0.014). In this AIDA trial QCA substudy, rates of LOCE were significantly lower in Xience EES treated lesions in which devices were correctly sized according to the definitions of device diameter/RVD matching.

Management of Patients with Patent Foramen Ovale and Cryptogenic Stroke: An Update.

Patent foramen ovale (PFO) is a common benign finding in healthy subjects, but its prevalence is higher in patients with stroke of unclear cause (cryptogenic stroke). PFO is believed to be associated with stroke through paradoxical embolism, and certain clinical and anatomical criteria seem to increase the likelihood of a PFO to be pathological. Recent trials have shown that closure of PFO, especially if associated with an atrial septal aneurysm and/or a large interatrial shunt, may reduce the risk of recurrent stroke as compared to medical treatment. However, it remains challenging to risk stratify patients with suspected PFO-related stroke and to decide if device closure is indicated. We sought to review contemporary evidence and to conclude an evidence-based strategy to prevent recurrence of PFO-related stroke.

Aortic Root Geometric and Dynamic Changes After Device Closure of Interatrial Shunts.

BACKGROUND: The spatial relationship between atrial septal occluders and the aorta and the subsequent impact on the geometry and mechanics of the aortic root have been underinvestigated. The aim of this study was to evaluate occluder-aorta interaction after device closure of an atrial septal defect (ASD) or a patent foramen ovale (PFO) using three-dimensional transesophageal echocardiography and two-dimensional speckle-tracking echocardiography. METHODS: In 65 adult patients (mean age, 47 ± 14 years; 71% women) who underwent ASD (n = 35) or PFO (n = 30) closure with the Amplatzer Septal Occluder or Amplatzer PFO Occluder, occluder-aorta contact was evaluated on three-dimensional transesophageal echocardiography and defined as continuous, intermittent, or absent. Sinus of Valsalva diameter, height, eccentricity, and strain were measured before and immediately after occluder implantation. RESULTS: The occluder/total septal length and occluder/body surface area ratios were significantly larger after PFO than after ASD closure. The occluder was in contact with the aorta in 93.8% of cases (ASD, 91.4%; PFO, 96.7%). After ASD closure, occluder-aorta contact was very common, in patients with an aortic rim < 5 mm (100%) and those with an aortic rim ≥ 5 mm (79%). However, continuous occluder-aorta contact was more frequent in those with an aortic rim < 5 mm (95% vs 50%). Factors influencing aortic root strain after occluder implantation included the pattern of occluder-aorta relationship and the occluder/body surface area ratio. CONCLUSIONS: Most interatrial septal occluders are in contact with the aortic root, even in patients with ASDs with a sufficient aortic rim and in patients with PFOs. However, continuous occluder-aorta contact is more likely in patients with ASDs with a deficient aortic rim. The pattern of occluder-aorta relationship and the occluder/body surface area ratio affect aortic root strain.

Impact of atrial septal defect closure on diffusing capacity for nitric oxide and carbon monoxide.

Atrial septal defects are characterised by a low D LNO /D LCOc ratio in diffusion testing. Successful percutaneous closure shows an increase in D LNO /D LCOc ratio and vital capacity through correction of a hyperdynamic pulmonary circulation. http://ow.ly/Rqkc30o5yMM.

Electrical remodeling after percutaneous atrial septal defect closure in pediatric and adult patients.

BACKGROUND: Several studies have reported changes in electrocardiographic variables after atrial septal defect (ASD) closure. However no temporal electro-and vectorcardiographic changes have been described from acute to long-term follow-up at different ages. We aimed to study electrical remodeling after percutaneous ASD closure in pediatric and adult patients. METHODS: ECGs of 69 children and 75 adults (median age 6 [IQR 4-11] years and 45 [IQR 33-54] years, respectively) were retrospectively selected before percutaneous ASD closure and at acute (1-7 days), intermediate (4-14 weeks) and late (6-18 months) follow-up. Apart from electrocardiographic variables, spatial QRS-T angle and ventricular gradient (VG) were derived from mathematically-synthesized vectorcardiograms. RESULTS: In both pediatric and adult patients, the heart rate decreased immediately post-closure, which persisted to late follow-up. The P-wave amplitude also decreased acutely post-closure, but remained unchanged at later follow-up. The PQ duration shortened immediately in children and at intermediate follow-up in adults. The QRS duration and QTc interval decreased at intermediate-term follow-up in both children and adults. In both groups the spatial QRS-T angle decreased at late follow-up. The VG magnitude increased at intermediate follow-up in children and at late follow-up in adults, after an initial decrease in children. CONCLUSION: In both pediatric and adult ASD patients, electrocardiographic changes mainly occurred directly after ASD closure except for shortening of QRS duration and QTc interval, which occurred at later follow-up. Adults also showed late changes in PQ duration. At 6-to-18 month post-closure, the spatial QRS-T angle decreased, reflecting increased electrocardiographic concordance. The initial acute decrease in VG in children, which was followed by a significant increase, may be the effect of action potential duration dynamics directly after percutaneous ASD closure.

The relationship of pre-procedural Dmax based sizing to lesion level outcomes in Absorb BVS and Xience EES treated patients in the AIDA trial.

Due to expansion limits of the Absorb bioresorbable scaffold a meticulous implantation with correct sizing is required. We sought to investigate the clinical outcomes based on the sizing of the device related to the maximal lumen diameter measured by quantitative coronary angiography in Absorb BVS and Xience EES treated lesions in the AIDA trial. Sizing of Absorb bioresorbable vascular scaffold (BVS) and Xience everolimus eluting stent (EES) was graded according to the definitions of device non-oversize and device oversize on pre-procedural angiography. Lesion-oriented outcomes (LOCE) (device thrombosis, TLR and TVMI) that occurred during 2 years follow-up were related to device non-oversized or oversized status. In the Absorb BVS group, LOCE occurred in 48 (7.4%) lesions in the oversized group and in 32 (8.2%) lesions in the non-oversized group (HR 0.91; 95% CI 0.58-1.42; p = 0.681), whereas TLR occurred in 34 (5.3%) lesions and in 23 lesions (5.9%), respectively (HR 0.89; 95% CI 0.52-1.51; p = 0.666). Definite scaffold thrombosis occurred in 11 (1.7%) device oversized treated lesions against 16 (4.1%) device non-oversized treated lesions (HR 0.41; 95% CI 0.19-0.89; p = 0.020). There were no differences in event rates between oversized and non-oversized groups in lesions treated with Xience EES. There was no significant difference in LOCE between oversized and non-oversized treated Absorb BVS and Xience EES treated lesions. Non-oversized Absorb BVS implantation was associated with a higher risk of scaffold thrombosis at complete 2 years follow-up. The majority of very late scaffold thrombosis occurred in properly sized devices.

Predictors of residual tricuspid regurgitation after percutaneous closure of atrial septal defect.

Aims: Functional tricuspid regurgitation (TR) associated with atrial septal defects (ASDs) is frequently present due to right-sided volume-overload. Tricuspid valve (TV) repair is often considered in candidates for surgical ASD closure, and percutaneous TV repair is currently under clinical investigation. In this study, we develop a prediction model to identify patients with residual moderate/severe TR after percutaneous ASD closure. Methods and results: In this observational study, 172 adult patients (26% male, age 49 ± 17 years) with successful percutaneous ASD closure had pre- and post-procedural echocardiography. Right heart dimensions/function were measured. TR was assessed semi-quantitatively. A prediction model for 6-month post-procedural moderate/severe TR was derived from uni-and multi-variable logistic regression. Clinical follow-up (FU) was updated and adverse events were defined as cardiovascular death or hospitalization for heart failure. Pre-procedural TR was present in 130 (76%) patients (moderate/severe: n = 64) of which 72 (55%) had ≥1 grade reduction post-closure. Independent predictors of post-procedural moderate/severe TR (n = 36) were age ≥60 years [odds ratio (OR) 2.57; P = 0.095], right atrial end-diastolic area ≥10cm2/m2 (OR 3.36; P = 0.032), right ventricular systolic pressure ≥44 mmHg (OR 6.44; P = 0.001), and tricuspid annular plane systolic excursion ≤2.3 cm (OR 3.29; P = 0.037), producing a model with optimism-corrected C-index = 0.82 (P < 0.001). Sensitivity analysis excluding baseline none/mild TR yielded similar results. Patients with moderate/severe TR at 6-month FU had higher adverse event rates [hazard ratio = 6.2 (95% confidence interval 1.5-26); log-rank P = 0.004] across a median of 45 (30-76) months clinical FU. Conclusion: This study shows that parallel to reduction of volume-overload and reverse remodelling after percutaneous ASD closure, TR improved substantially despite significant TR at baseline. Our proposed risk model helps identify ASD patients in whom TR regression is unlikely after successful percutaneous closure.

Use of Pulmonary Inhalants Remains Remarkably High After Atrial Septal Defect Closure.

BACKGROUND: Post-repair atrial septal defects (ASD) patients are frequently discharged from follow-up, but the extent of pulmonary symptoms long-term post-repair is unknown. Methods and Results: The national CONgenital CORvitia registry was linked to the national Drug Registry to investigate all ambulatory-dispensed pulmonary inhalants for 2006-2014. ASD patients were compared with age- and sex-matched referents from the general population. A total of 1,959 adult patients (age 42±17 years; 66% female; 1,223 [62%] repaired) were included. Compared with the referents, ASD patients had more inhalant use, even at long-term post-repair follow-up (OR=1.81 [95% CI 1.62-2.03]; P<0.001). CONCLUSIONS: ASD patients had 2-fold higher inhalant use compared with referents even at long-term post-repair follow-up, suggesting persistent pulmonary functional impairment.

Atrial septal defect in adults is associated with airway hyperresponsiveness.

OBJECTIVE: The association between secundum atrial septal defects (ASD) and asthma-like dyspnea with consequent long-term pulmonary inhalant use, is poorly understood in adult ASD patients. Airway hyperresponsiveness is suggested to be the underlying mechanism of cardiac asthma from mitral valve disease and ischemic cardiomyopathy. We hypothesized that airway hyperresponsiveness may also be found in adult ASD patients. Our aim was to study airway responsiveness in adult ASD patients before percutaneous closure and at short-and long-term postprocedural follow-up. METHODS: This prospective study included 31 ASD patients (65% female, mean age 49 ± 15y) who underwent spirometry and bronchoprovocation testing pre-and six-month postprocedurally, with additional bronchoprovocation at 2-year follow-up. Airway hyperresponsiveness was defined as ≥20% fall of forced expiratory volume in 1-second (FEV1 ) following <8.0 mg/mL of inhaled methacholine. RESULTS: Airway hyperresponsiveness was found in 19/30 patients (63%[95%CI 45%-81%]; post hoc statistical power = 89%). Asthma-like symptoms wheezing, chest tightness, and cough were more frequently reported in airway hyperresponsive patients. Airway responsiveness was not influenced by successful percutaneous ASD closure, corresponding to persistence of asthma-like symptoms postclosure. Regardless of airway responsiveness, postprocedural right-sided reverse remodeling significantly improved dyspnea and pulmonary function. CONCLUSIONS: This study is the first to report a high prevalence of airway hyperresponsiveness in a cohort of unrepaired adult ASD patients, and confirms the association between asthma-like symptoms and ASD in adults. Attention to symptoms and pulmonary function should be given during clinical follow-up of adult ASD patients, both before and long after repair.

Infective Endocarditis After Melody Valve Implantation in the Pulmonary Position: A Systematic Review.

BACKGROUND: Infective endocarditis (IE) after transcatheter pulmonary valve implantation (TPVI) in dysfunctioning right ventricular outflow tract conduits has evoked growing concerns. We aimed to investigate the incidence and the natural history of IE after TPVI with the Melody valve through a systematic review of published data. METHODS AND RESULTS: PubMed, EMBASE, and Web of Science databases were systematically searched for articles published until March 2017, reporting on IE after TPVI with the Melody valve. Nine studies (including 851 patients and 2060 patient-years of follow-up) were included in the analysis of the incidence of IE. The cumulative incidence of IE ranged from 3.2% to 25.0%, whereas the annualized incidence rate ranged from 1.3% to 9.1% per patient-year. The median (interquartile range) time from TPVI to the onset of IE was 18.0 (9.0-30.4) months (range, 1.0-72.0 months). The most common findings were positive blood culture (93%), fever (89%), and new, significant, and/or progressive right ventricular outflow tract obstruction (79%); vegetations were detectable on echocardiography in only 34% of cases. Of 69 patients with IE after TPVI, 6 (8.7%) died and 35 (52%) underwent surgical and/or transcatheter reintervention. Death or reintervention was more common in patients with new/significant right ventricular outflow tract obstruction (69% versus 33%; P=0.042) and in patients with non-streptococcal IE (73% versus 30%; P=0.001). CONCLUSIONS: The incidence of IE after implantation of a Melody valve is significant, at least over the first 3 years after TPVI, and varies considerably between the studies. Although surgical/percutaneous reintervention is a common consequence, some patients can be managed medically, especially those with streptococcal infection and no right ventricular outflow tract obstruction.

Cardiac diagnostic work-up of ischaemic stroke.

Cardioembolic sources account for 20-30% of ischaemic strokes and are important to identify considering their prognostic and therapeutic implications. During the past years, new developments have been made in the cardiac diagnostic evaluation and management of patients with ischaemic stroke, especially regarding strokes of unknown aetiology. These recent advances have had a major impact on our understanding of embolic strokes, their diagnostic work-up, and clinical management. Herein, we propose a cardiac diagnostic work-up scheme for patients with ischaemic stroke from definite cardioembolic sources and embolic strokes of undetermined source.

Implantation techniques (predilatation, sizing, and post-dilatation) and the incidence of scaffold thrombosis and revascularisation in lesions treated with an everolimus-eluting bioresorbable vascular scaffold: insights from the AIDA trial.

AIMS: Specific implantation strategies have been proposed for the Absorb bioresorbable vascular scaffold (Absorb BVS) to optimise outcomes. We aimed to analyse whether the occurrence of definite scaffold thrombosis (ScT) and target lesion revascularisation (TLR) in Absorb-treated AIDA patients was influenced by scaffold implantation techniques. METHODS AND RESULTS: Absorb BVS implantation in 1,074 lesions was graded according to definitions of optimal implantation based on predilatation, sizing, and post-dilatation (PSP). Lesion-oriented outcomes (definite ScT and TLR) that occurred during a median follow-up of 707 days were related to the presence or absence of PSP. Of 1,074 lesions, 158 (14.7%) lesions met PSP criteria. The most prevalent reason for not meeting PSP criteria was inadequate sizing: 863 (94.2%). Definite ScT occurred in four of 158 PSP-treated lesions compared with 27 of 916 non PSP-treated lesions, with two-year KM estimates of 3.0% vs. 4.1% and an HR of 1.14 (p=0.811). TLR occurred in eight of 158 PSP-treated lesions compared with 61 of 916 non PSP-treated lesions, with KM estimates of 5.6% vs. 7.1% and an HR of 1.29 (p=0.492). CONCLUSIONS: In AIDA, lesions that underwent scaffold implantation according to an optimised Absorb BVS implantation technique did not have lower rates of ScT and TLR compared to scaffold-treated lesions that did not meet PSP criteria.

Historical developments of atrial septal defect closure devices: what we learn from the past.

INTRODUCTION: Since King and Mills' pioneering work in percutaneous closure devices of secundum atrial septal defects (ASD) four decades ago, developments in device shape, material and implantation technique led to adoption of percutaneous ASD closure as current treatment of choice. Not only was the feasibility of such a percutaneous procedure tested altogether, but pursuing the ideal device in terms of safety and efficacy became priority. AREAS COVERED: In this review we present the historical development of ASD devices in design, material and technique with clinical data, and provide the future perspectives in percutaneous ASD closures. EXPERT OPINION: An 'ideal device' requires complete defect closure with negligible risk of complications using a safe, straightforward delivery technique with repositioning and retrieving properties. Some of the devices currently at hand come close to fulfilling these criteria, however none seem to provide those prerequisites completely. By understanding how challenges in device development were overcome in the past, new insights into future improvements are given.

First-in-man evaluation of the novel balloon delivery system STENTYS Xposition S for the self-apposing coronary artery stent: impact on longitudinal geographic miss during stenting.

AIMS: A novel balloon delivery system (BDS) for the self-apposing STENTYS sirolimus-eluting stent (SES) has been developed for highly precise longitudinal stent positioning and deployment. The aim of this first-in-man study is to report the quantitative coronary analysis (QCA) angiography and optical coherence tomography (OCT) results as well as the 30-day clinical outcomes of the STENTYS Xposition S SES. METHODS AND RESULTS: We included 25 patients (mean age 66.1±10.7 years) with stable coronary artery disease (24%) or acute coronary syndrome (including STEMI in 40%). The device was successfully placed at the intended site in all cases (100%), without procedural complications. Longitudinal geographic miss (entire lesion length [on QCA] not completely covered by the stent) was not observed. Pre-procedural MLD on QCA was 1.30±0.74 mm and post-procedural MLD was 2.74±0.44 mm, p<0.001 (acute gain 1.44±0.70 mm). OCT analyses showed a low percentage of malapposed stent struts directly post stent placement (2.4%), which further decreased after post-dilatation (0.6%, p=0.013), while mean stent area increased (from 9.7 mm2 to 10.5 mm2, p<0.001). At 30-day clinical follow-up, one (4%) major adverse cardiac event (MACE) was observed. One acute stent thrombosis (ST) occurred immediately post procedure in a STEMI patient which was related to inadequate medication therapy. CONCLUSIONS: This first-in-man study demonstrated that the use of the novel STENTYS Xposition S balloon delivery system is feasible with a high technical success rate without longitudinal geographical miss. Stent strut malapposition rate directly after STENTYS placement was low and improved further after post-dilatation.

Electrocardiographic P wave changes after thoracoscopic pulmonary vein isolation for atrial fibrillation.

BACKGROUND: Changes in P wave duration (PWD) and P wave area (PWA) have been described following catheter ablation for atrial fibrillation (AF). We hypothesize that video-assisted thoracoscopic pulmonary vein isolation (VATS-PVI) for AF results in decrease of PWD, PWA and P wave dispersion, which may resemble reverse electrical remodeling of the atrium after restoration of sinus rhythm. METHODS: VATS-PVI consisted of PVI and ganglionic plexus ablation in 29 patients (mean age, 59 ± 7 years; 23 males; 17 paroxysmal AF) and additional left atrial lesions in patients with persistent AF. PWD and PWA were measured in ECG lead II, aVF and V2 of ECGs during sinus rhythm before, directly after, and 6 months postprocedure. P wave dispersion was derived from the 12 lead ECG. RESULTS: Prior to VATS-PVI, PWD did not correlate with left atrial size and no difference in left atrial size was found between patients with paroxysmal or persistent AF (p = 0.27). Following VATS-PVI, PWD initially prolonged in all patients from 115 ± 4.6 ms to 131 ± 3.6 ms (p < 0.01) but shortened to 99 ± 3.2 ms after 6 months (p < 0.01). PWA was 5.60 ± 0.32 mV*ms at baseline, 6.44 ± 0.32 mV*ms post-VATS-PVI (P = NS), and 5.40 ± 0.28 mV*ms after 6 months (p = NS vs. baseline, p < 0.05 vs. post-VATS-PVI). P wave dispersion decreased in the persistent AF group from baseline 67 ± 3.3 to 64 ± 2.5 ms post-VATS-PVI (p = 0.30) and to 61 ± 3.4 ms after 6 months (p < 0.05). CONCLUSIONS: PWD increases significantly directly after successful VATS-PVI in both groups. There was significant decrease in PWD after 6 months. Similarly, P wave dispersion decreased in the persistent group. These changes suggest an immediate procedure related effect, but the later changes may represent reverse electrical atrial remodeling following cessation of AF.