Aortic luminal remodeling after intravascular stent therapy for coarctation of the aorta: intermediate results.

OBJECTIVE: Outcomes after adult coarctation of the aorta (CoA) stenting is scant. We explored predictors of aortic remodeling after stent implantation and report early- and intermediate-term clinical outcomes. METHODS: Adult patients who underwent stenting between July 2003 and December 2017 were included in this single-center retrospective study. We created a novel index of aortic volumetric and diameter changes using computed tomography (CT)/magnetic resonance (MR) images measured through TeraRecon and AngioQ. Predictors of aortic remodeling were explored using univariable linear regression analysis. RESULTS: One hundred and thirty-four patients (mean age 35.2 years, 58.2% men) underwent CoA stenting. Paired aortic diameter measurements were available in 20 patients, and 40 paired patients in volumetric measurements. There was significant reduction in aortic diameter immediately proximal to the left carotid and subclavian arteries, and the aorta distal to the stenosis (P less than .05) at follow-up. There was a significant volumetric reduction in the ascending aorta, aortic arch, and the aortic segment most proximal to the top of the stent (P less than .05). Univariate predictors of aortic remodeling included sex, age, presence of previous surgical repair, aortic valve morphology, and the number of antihypertensive medications. Mean follow-up time was 4.0 ± 3.8 years, where 5% of patients underwent reintervention due to complications, 3% developed aneurysms, and 3% had stent fractures. CONCLUSIONS: This study is the first to examine the anatomical changes that occur in the aorta post stent repair through analysis of serial imaging. Patients with stent-repaired coarctation demonstrated negative remodeling in multiple areas of the aorta with regards to the aortic diameter and volumetric measurements.

Real world long-term outcomes among adults undergoing transcatheter patent foramen closure with amplatzer PFO occluder.

BACKGROUND: Patent foramen ovale (PFO) is a congenital heart defect associated with an increased risk of cryptogenic stroke. We aimed to evaluate real-world outcomes of adult patients undergoing transcatheter PFO closure with the Amplatzer PFO Occluder. METHODS: In this single centre, retrospective cohort study, we linked a detailed clinical registry with provincial administrative databases to obtain short and long-term outcomes. Validated algorithms were used to established baseline comorbidities and adverse outcomes. RESULTS: Between 1999 and 2017, 479 patients had PFO closure with an Amplatzer PFO Occluder. The average age of the patients was 47.3 years (standard deviation (SD) = 12.4), and 54.7% were males. The procedural success was 100%, and 96% of patients were discharged on the same day. Any in-hospital complication was observed in 2.5% (n = 12) of patients. At 30 days post-discharge, 18% of patients had an ED visit and 5% a hospitalization. Over a mean follow-up of 9.1 (SD = 3.8) years, 4% experienced TIA, 1.5% stroke, and 7.6% atrial fibrillation. The composite outcome of stroke/TIA/death was observed in 10.9% of patients (1.22 events per 100 person-years). Patients >60 years old experienced higher rates of adverse events than younger patients. CONCLUSIONS: In this large real-world cohort of patients with cryptogenic stroke, we observed excellent safety and effectiveness outcomes for PFO closure conducted with Amplatzer PFO Occluder, similar to randomized controlled trials or other long-term cohort studies. New onset atrial fibrillation was one of the most commonly adverse events. Future studies should investigate early post-discharge management of patients to prevent readmissions.

An unusual pair: coronary artery fistula and coronary sinus ostium stenosis as a cause of refractory angina.

Background: Coronary fistula are rare and often present in early adulthood with symptoms of right heart overload from left to right shunting or ischaemia in the distal coronary bed due to coronary steal. Case summary: A 73-year-old lady with prior history of supraventricular tachycardia, dyslipidemia and a right coronary artery (RCA) to coronary sinus (CS) fistula, presented with progressive angina. She did not have evidence of ischaemia in the RCA territory on nuclear imaging, and cardiac computed tomography (CT) did not show coronary artery disease but revealed a significantly dilated CS and coronary venous tree. She was found to have CS ostial stenosis and, under transesophageal echocardiographic guidance, underwent successful balloon angioplasty of the CS ostium, with decompression of the coronary venous circulation and resolution of her angina. Discussion: Coronary fistula draining to the CS are rare, and association with CS ostial stenosis has been reported very infrequently. CS ostial stenosis can cause elevated coronary venous pressure, leading to decreased global coronary perfusion and symptoms of angina or heart failure. Previous case reports of coronary fistula and CS ostial stenosis were treated with either medical therapy or surgery, and our case is the first to our knowledge to report successful percutaneous treatment.

Sex differences in baseline profiles and short-term outcomes in patients undergoing closure of patent foramen ovale.

Objectives: Although sex differences have been emphasized in stroke and congenital heart disease, there has been limited investigation into their role in patent foramen ovale (PFO) closure for secondary prevention of stroke. We aimed to explore differences by sex in baseline profiles, procedural characteristics, and short-term outcomes of patients undergoing transcatheter PFO closure. Methods: Data of adult patients undergoing transcatheter PFO closure at the Toronto General Hospital from 1997 to 2017 was retrospectively analyzed. Baseline information included demographic characteristics, medical history, diagnostic, and procedural information, and periprocedural complications. Post-closure outcomes were captured at index hospitalization and during the first follow-up. Results: From 1031 patients in the cohort sample, 80.7 % underwent closure for cryptogenic stroke and 44.7 % (n = 461) were females. We observed significant sex-related differences in baseline characteristics; females were younger, less likely to have a history of smoking, and less likely to have several cardiovascular risk factors at baseline (p < 0.05). The median time to first follow-up was 89 days for both groups. Recurrent stroke was observed in 0.1 % and TIA observed in 0.4 % of in the 'cryptogenic stroke/TIA' group; in the 'other indications' group, 1.4 % stroke and no TIA were reported. No significant differences were present between sexes. Conclusions: There were no differences in procedural and short-term outcomes between males and females undergoing transcatheter PFO closure, but significant baseline differences in risk factors were identified. There is a critical need for long-term, systematic studies to understand sex and gender differences in the PFO population.

Coronary Artery Disease in Adults Undergoing Percutaneous Patent Foramen Ovale Closure Following Cryptogenic Stroke.

BACKGROUND: A patent foramen ovale (PFO) is found in nearly half of patients with cryptogenic stroke. Little guidance on the use or necessity of coronary angiography at the time of percutaneous PFO closure exists. We aimed to characterize the presence of coronary artery disease (CAD) in patients undergoing PFO closure following a cryptogenic stroke. METHODS: A retrospective analysis of consecutive patients who underwent concurrent percutaneous PFO closure and coronary angiography was performed. Patients were ≥40 years of age and had a preceding diagnosis of cryptogenic stroke with no known CAD. Visual analysis of coronary angiograms was performed. RESULTS: Of 180 patients, 8 (4%) had severe CAD, 15 (8%) had moderate CAD, 32 (18%) had mild CAD, and 12 (7%) had luminal irregularities. Of those with moderate-to-severe CAD, 9 (5%) had proximal disease and 9 (5%) had multivessel disease. Of those with moderate-to-severe CAD, 8 (35%) underwent further risk stratification with stress testing, 4 (17%) were medically managed, and 1 (4%) underwent concurrent angioplasty. CONCLUSIONS: Coronary angiography identified a low prevalence of CAD in patients with cryptogenic stroke undergoing PFO closure, suggesting that coronary angiography is not routinely indicated in patients undergoing PFO closure.

Routine Coronary Angiography in Adults Undergoing Percutaneous Atrial Septal Defect Closure: Implications for Practice Guidelines.

OBJECTIVES: Secundum atrial septal defect (ASD) is a common adult congenital heart lesion for which percutaneous closure offers treatment in patients with suitable anatomy. We sought to determine the outcomes of coronary angiography in a population of adults >40 years of age who were undergoing percutaneous ASD closure. METHODS: Patients >40 years of age who underwent ASD closure between 2009-2016 were included in this retrospective chart review. Coronary angiograms were reviewed by 2 independent reviewers to evaluate the presence and degree of coronary artery disease (CAD) and the resulting clinical sequelae. RESULTS: A total of 398 patients underwent ASD closure, and 300 had coronary angiography at the time of closure. Mild CAD (10%-39% vessel stenosis) was found in 33 patients (11.0%), moderate CAD (40%-69% vessel stenosis) in 23 patients (7.7%), and severe CAD (≥70% vessel stenosis) in 25 patients (8.3%). Of the 48 patients with moderate to severe CAD, 24 had proximal vessel disease and 21 had multivessel disease. Four patients (8.3%) with moderate to severe CAD subsequently underwent percutaneous interventions, 16 patients (33.3%) had medication changes, 16 patients (33.3%) had perfusion testing followed by medication changes, and 12 patients (25%) had no changes in their medical management. CONCLUSIONS: Given the prevalence of CAD in this population, routine coronary angiography at the time of ASD closure should be reserved for patients with an unfavorable cardiovascular risk profile, who have a higher likelihood of CAD. While patients with ASDs suffer from chest pain and dyspnea both before and after percutaneous closure, few have established CAD.

Long-Term Outcomes After Atrial Septal Defect Transcatheter Closure by Age and Against Population Controls.

OBJECTIVES: The long-term outcomes after transcatheter closure of atrial septal defects (ASD) in adults are reported and compared between age groups and against population control patients. BACKGROUND: ASD is the second most common lesion in congenital heart disease. Comprehensive data on long-term outcomes after ASD closure are limited. METHODS: This retrospective cohort study enrolled adult patients with secundum ASD closure between 1998 and 2016. Information from a detailed clinical registry was linked to population-based administrative databases to capture outcomes. The population control cohort was matched using important prognostic characteristics. RESULTS: The cohort included 1,390 ASD patients of whom 32% were <40 years of age, 45% were 40 to 60 years of age, and 23% were >60 years of age at closure. The median follow-up was 10.6 years (interquartile range: 6.2 to 14.0 years). New-onset atrial fibrillation (AF) was the most frequent outcome overall (14.9%). The incidence of adverse cardiac and cerebrovascular events was higher in the >60 years of age group than in the younger groups. In adjusted analysis, patients >60 years of age continued exhibiting higher risk of all-cause (hazard ratio [HR]: 8.54; 95% confidence interval [CI]: 93.40 to 21.43) and cardiovascular (CV)-specific mortality compared with the <40 years of age group. The risk of new-onset AF (HR: 3.73; 95% CI: 2.79 to 4.98) and any AF hospitalization (HR: 1.55; 95% CI: 1.28 to 1.89) was higher in the ASD than in the control population, whereas there was no difference in all-cause and CV-specific mortality. CONCLUSIONS: As expected, rates of adverse events post-ASD closure are higher in older age groups, but long-term mortality was comparable to that of a population control cohort. The high rates of AF necessitate future investigations.

Clinical Outcomes After Percutaneous Patent Ductus Arteriosus Closure in Adults.

BACKGROUND: There is little published data regarding percutaneous patent ductus arteriosus (PDA) closure in adults. We aim to describe the outcomes of adult patients undergoing PDA closure at a single tertiary referral centre. METHODS: All adults who underwent device PDA closure at our centre from 2001 to 2017 were identified and enrolled in the study. Available clinical data and imaging data were reviewed. RESULTS: At total of 141 patients were identified, with a mean age of 43 ± 15 years. Left ventricular dilation was present in 27% and pulmonary hypertension in 36% of the patients. Most ducts (74%) were of type A morphology. Mean ductal diameter at the pulmonary artery end was 4.1 ± 1.9 mm and mean length was 10.0 ± 4.7 mm. Wire passage from the pulmonary artery was achieved in 79%. Procedural success rate was 100%, and an Amplatzer duct occluder was deployed in all successful cases (ADO1 device in 97%). There was a small residual shunt in 6% at the time of closure, and only 2 patients had a residual leak on echocardiography at a median 3 months' follow-up. No major complications occurred. CONCLUSIONS: Transcatheter PDA closure with the use of an Amplatzer duct occluder is very effective in adults across all duct morphologies and associated with a very low complication rate.

Three-Year Outcomes From the Harmony Native Outflow Tract Early Feasibility Study.

BACKGROUND: The Harmony transcatheter pulmonary valve (TPV) was designed for treatment of postoperative pulmonary valve regurgitation in patients with repaired right ventricular outflow tracts. METHODS: The Native TPV EFS (Early Feasibility Study) is a prospective, multicenter, nonrandomized feasibility study. Three-year outcomes are reported. RESULTS: Of 20 implanted patients, 17 completed 3-year follow-up (maximum: 4.1 years). There were no deaths and 2 early explants. One patient did not complete the 3-year visit. In patients with available 3-year echocardiographic data, 1 had a mild paravalvular leak and the rest had none/trace; 1 patient had mild pulmonary valve regurgitation and the remainder had none/trace. The 3-year mean right ventricular outflow tract echocardiographic gradient was 15.7±5.5 mm Hg. Radiographically, no late frame fractures or erosions were identified. At 2 years, 2 patients presented with an increased echocardiographic outflow gradient (1 mixed lesion with moderate/severe pulmonary valve regurgitation). Computed tomography scans identified neointimal tissue ingrowth within the stent frame in both patients, and they were treated successfully with a transcatheter valve-in-valve procedure (Melody TPV). Additional follow-up computed tomography scans performed at 3.2±0.5 years after implant were obtained in 16 patients and revealed luminal tissue thickening at the inflow and outflow portion of the frame with no significant alteration of the valve housing. CONCLUSIONS: Three-year results from the Native TPV EFS revealed stable Harmony TPV device position, good valve function in most, and the absence of moderate/severe paravalvular leak and significant late frame fractures. Two patients developed significant neointimal proliferation requiring valve-in-valve treatment, while all others had no clinically significant right ventricular outflow tract obstruction. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01762124.

Proposal for Updated Nomenclature and Classification of Potential Causative Mechanism in Patent Foramen Ovale-Associated Stroke.

Importance: Recent epidemiologic and therapeutic advances have transformed understanding of the role of and therapeutic approach to patent foramen ovale (PFO) in ischemic stroke. Patent foramen ovale is likely responsible for approximately 5% of all ischemic strokes and 10% of those occurring in young and middle-aged adults. Observations: Randomized clinical trials have demonstrated that, to prevent recurrent ischemic stroke in patients with PFO and an otherwise-cryptogenic index ischemic stroke, PFO closure is superior to antiplatelet medical therapy alone; these trials have provided some evidence that, among medical therapy options, anticoagulants may be more effective than antiplatelet agents. Conclusions and Relevance: These new data indicate a need to update classification schemes of causative mechanisms in stroke, developed in an era in which an association between PFO and stroke was viewed as uncertain. We propose a revised general nomenclature and classification framework for PFO-associated stroke and detailed revisions for the 3 major stroke subtyping algorithms in wide use.

Validation of Quantitative 3-Dimensional Transesophageal Echocardiography Mitral Valve Analysis Using Stereoscopic Display.

OBJECTIVE: The use of 3-dimensional (3D) transesophageal echocardiography (TEE) in perioperative evaluation of the mitral valve (MV) is increasing progressively, including the use of 3D MV models for quantitative analysis. However, the use of 3D MV models in clinical practice still is limited by the need for specific training and the long time required for analysis. A new stereoscopic visualization tool (EchoPixel True 3D) allows virtual examination of anatomic structures in the clinical setting, but its accuracy and feasibility for intraoperative use is unknown. The aim of this study was to assess the feasibility of 3D holographic display and evaluate 3D quantitative measurements on a volumetric MV image using the EchoPixel system compared with the 3D MV model generated by QLAB Mitral Valve Navigation (MVN) software. DESIGN: This was a retrospective comparative study. SETTING: The study took place in a tertiary care center. PARTICIPANTS: A total of 40 patients, 20 with severe mitral regurgitation who underwent mitral valve repair and 20 controls with normal MV, were enrolled retrospectively. INTERVENTIONS: The 3D-TEE datasets of the MV were analyzed using a 3D MV model and stereoscopic display. The agreement of measurements, intraobserver and interobserver variability, and time for analysis were assessed. MEASUREMENTS AND MAIN RESULTS: Fair agreement between the 2 software systems was found for annular circumference and area in pathologic valves, but good agreement was reported for prolapse height and linear annular diameters. A higher agreement for all annular parameters and prolapse height was seen in normal valves. Excellent intraobserver and interobserver reliability was proved for the same parameters; time for analysis between the 2 methods in pathologic valves was substantially equivalent, although longer in pathologic valves when compared with normal MV using both tools. CONCLUSION: EchoPixel proved to be reliable to display 3D TEE datasets and accurate for direct linear measurement of both MV annular sizes and prolapse height compared to QLAB MVN software; it also carries a low interobserver and intraobserver variability for most measurements.

Harmony Feasibility Trial: Acute and Short-Term Outcomes With a Self-Expanding Transcatheter Pulmonary Valve.

OBJECTIVES: This study sought to obtain in vivo data to confirm assumptions on device loading conditions and assess procedural feasibility, safety, and valve performance. BACKGROUND: The Harmony transcatheter pulmonary valve (Medtronic, Minneapolis, Minnesota) was designed for patients with severe pulmonary regurgitation who require pulmonary valve replacement. METHODS: Three sites participated in this first Food and Drug Administration-approved early feasibility study using an innovative device design to accommodate the complex anatomy of the right ventricular outflow tract. Potentially eligible patients underwent review by a screening committee to determine implant eligibility. Six-month outcomes are reported. RESULTS: Between May 2013 and May 2015, 66 subjects were enrolled, and 21 were approved for implant and underwent catheterization; 20 were implanted. Catheterized patients had a median age of 25 years, were predominantly diagnosed with tetralogy of Fallot (95%), had severe pulmonary regurgitation (95%), and had trivial or mild stenosis. The device was delivered in the desired location in 19 of 20 (95%) patients. Proximal migration occurred in 1 patient during delivery system removal. Two devices were surgically explanted. Premature ventricular contractions related to the procedure were reported in 3 patients; 2 were resolved without treatment. One patient had ventricular arrhythmias that required treatment and later were resolved. At 1 month, echocardiography revealed none or trivial pulmonary regurgitation in all and a mean right ventricular outflow tract gradient of 16 ± 8 mm Hg (range 6 to 31 mm Hg). CONCLUSIONS: In this feasibility study of the Harmony transcatheter pulmonary valve device, there was high procedural success and safety, and favorable acute device performance.