Search

Patent foramen ovale (PFO) is a common congenital cardiac abnormality. Risk of stroke increases perioperatively, but the association of PFO with perioperative stroke risk remains unclear. We conducted a systematic review to inform the risk of perioperative stroke in patients with PFO undergoing surgery.Embase, MEDLINE, and Cochrane databases were searched from inception to January 2020. We described methods used for establishing PFO and perioperative stroke diagnosis. We conducted meta-analyses to obtain pooled estimates for risk of stroke in patients with and without PFO in different surgical populations.Ten articles with a total of 20,858,011 patients met the eligibility criteria. Prevalence of PFO ranged from 0.06% to 1.4% based on International Classification of Diseases (ICD)-code diagnosis and from 10.4% to 40.4% based on echocardiography diagnosis. Perioperative stroke was observed in 0% to 25% of patients with PFO, and 0% to 16.7% without PFO. Studies that used echocardiography to diagnose PFO found no association between PFO and perioperative stroke. Studies that used ICD codes found strong association but were highly heterogeneous. PFO was not associated with a risk of perioperative stroke in cardiac and transplantation surgeries. While the adjusted odds ratios for stroke were substantial for orthopaedic, general, genitourinary, neurologic, and thoracic surgeries (with PFO status established based on ICD codes), data heterogeneity and quality of data create significant uncertainty.In conclusion, PFO is likely a risk factor for perioperative stroke in selected types of surgeries. However, this is based on very low-quality evidence. Rigorous prospective studies are needed to further investigate this relationship.

Functional tricuspid regurgitation (TR) is a common pathophysiologic condition in adults with ostium secundum atrial septal defect (ASD). The aim of this study was to evaluate long-term outcomes following transcatheter ASD closure, which have not been well studied among patients with significant TR.We reviewed consecutive adult patients who underwent transcatheter ASD closure at Toronto General Hospital, Ontario, Canada, from 1998 to 2016. We linked our hospital registry with Ontario population-based health administrative databases to collect longitudinal data on inpatient and outpatient health care utilisation and vital status.In this cohort study of 949 patients, 199 (22%) had moderate to severe TR before transcatheter ASD closure. A significant proportion of patients (61%) showed improvement in TR severity to at least mild TR after ASD intervention. At a median follow-up of 10.9 years, patients with baseline mild or no TR, compared with those with greater than moderate TR, had significantly lower rates of all-cause mortality (6.8 vs 22.5 per 1000 person-years [PY]; P0.001), composite hospitalisation for atrial fibrillation (AF) or heart failure (HF) (22.3 vs 49.1 per 1000 PY; P0.001), and new onset of AF (10.4 vs 20.2 per 1000 PY; P = 0.002) and HF (5.0 vs 9.2 per 1000 PY; P = 0.039). Preprocedural TR was independently associated with higher all-cause mortality (adjusted hazard ratio 1.69, 95% confidence interval 1.08-2.62).TR severity was independently associated with a higher risk of mortality and morbidity. Further investigation of earlier device closure or concomitant tricuspid valve intervention may be of interest.

Background: Sarcopenia, the age-related loss of skeletal muscle mass/function, has been identified as a marker of frailty. We examined the association between sarcopenia and adverse events following transcatheter aortic valve implantation (TAVI). Methods: A retrospective cohort study was conducted at Toronto General Hospital. All patients who underwent TAVI in the time period 2007-2017 with preoperative computed tomography were included. Skeletal muscle index (SMI) was calculated radiographically using psoas muscle area at the L3 vertebral level, divided by height. Various measures of sarcopenia, including mean SMI, SMI below the sex-specific median, and SMI in the lowest sex-specific quartile were calculated. The primary outcome was postoperative adverse events, defined as a composite of in-hospital mortality and morbidity including cardiovascular, pulmonary, neurologic, access-related, and gastrointestinal complications. Univariate and multivariate logistic regression were performed to determine the association between sarcopenia and adverse events. Results: A total of 468 patients (mean age: 80.7 years) were included. Baseline comorbidity burden was high, particularly congestive heart failure (93.4%). Postoperative adverse events occurred in 62 patients (13.2%). Univariate logistic regression demonstrated that postoperative adverse events were correlated with mean SMI (odds ratio [OR] 0.81, 95% confidence interal [CI] 0.66-0.97), events were less than the SMI (OR 2.16, 95% CI 1.24-3.84), and SMI in the sex-specific lowest quartile (OR 2.34, 95% CI 1.33-4.07). On multivariate analysis, SMI in the sex-specific lowest quartile was an independent predictor of adverse events (OR 2.53, 95% CI 1.41-4.50). Conclusions: Sarcopenia defined by radiologic psoas muscle measurements was independently associated with in-hospital mortality and morbidity following TAVI. Résumé: Contexte: La sarcopénie, soit la perte de masse et de fonction des muscles squelettiques liée à l’âge, a été identifiée comme un marqueur de fragilité. Nous avons examiné l’association entre la sarcopénie et les événements indésirables suivant l’implantation valvulaire aortique par cathéter (IVAC). Méthodologie: Une étude de cohorte rétrospective a été menée au Toronto General Hospital. Tous les patients ayant subi une IVAC avec tomodensitométrie préopératoire au cours de la période 2007-2017 ont été inclus. L’indice de masse musculaire squelettique (IMMS) a été calculé par radiographie en utilisant la surface du psoas au niveau de la vertèbre L3, divisée par la taille. Diverses mesures de la sarcopénie, y compris l’IMMS moyen, l’IMMS sous la médiane selon le sexe et l’IMMS dans le quartile inférieur selon le sexe, ont été calculées. Le critère d’évaluation principal était les événements indésirables postopératoires, définis comme un critère composite comprenant la mortalité et la morbidité à l’hôpital, notamment les complications cardiovasculaires, pulmonaires, neurologiques, gastro-intestinales et liées à l’accès vasculaire. Des régressions logistiques univariée et multivariée ont été effectuées pour déterminer l’association entre la sarcopénie et les événements indésirables. Résultats: Un total de 468 patients (âge moyen : 80,7 ans) ont été inclus. Le fardeau de comorbidité au départ était élevé, en particulier pour ce qui est de l’insuffisance cardiaque congestive (93,4 %). Des événements indésirables postopératoires sont survenus chez 62 patients (13,2 %). La régression logistique univariée a montré que les événements indésirables postopératoires étaient en corrélation avec un IMMS moyen (rapport des cotes [RC] : 0,81, intervalle de confiance [IC] à 95 % : 0,66 à 0,97), un IMMS sous la médiane selon le sexe (RC : 2,16; IC à 95 % : 1,24 à 3,84) et un IMMS dans le quartile inférieur selon le sexe (RC : 2,34; IC à 95 % : 1,33 à 4,07). Lors de l’analyse multivariée, un IMMS situé dans le quartile inférieur selon le sexe était un prédicteur indépendant d’événements indésirables (RC : 2,53; IC à 95 % : 1,41 à 4,50). Conclusions: La sarcopénie définie par les mesures radiologiques du psoas était indépendamment associée à la mortalité et à la morbidité à l’hôpital à la suite d’une IVAC.

Atrial septal defect is a common congenital heart disease, producing a left-to-right shunt in the atrial septum; the current preferred treatment is transcatheter device closure. The aim is to conduct a systematic review to synthesize information on the comparative effectiveness and safety of atrial septal defect closure devices. The methods used: a comprehensive search of Ovid MEDLINE®, Embase, and Cochrane Central databases was conducted. Studies comparing procedural and follow-up outcomes of atrial septal defect devices were included. Network meta-analyses were conducted to generate direct and indirect evidence for comparative effectiveness and safety outcomes between devices. The results are as follows: Twelve studies met our inclusion criteria and were compared in network meta-analyses. The meta-analyses evaluated contemporary devices: the AMPLATZER Septal Occluder; the GORE CARDIOFORM Septal Occluder; the Figulla Flexible II Occluder; the CeraFlex Septal Occluder; and the HELEX Septal Occluder. These studies represented 3998 patients. The primary safety and efficacy outcomes were device embolization and follow-up residual shunt, respectively. Secondary clinical outcomes included procedural success and major and minor complications. No differences were found between devices in terms of device embolization and secondary clinical outcomes. Follow-up residual shunt was higher with the HELEX Septal Occluder compared with the AMPLATZER Septal Occluder (odds ratio 2.92, 95% confidence interval 1.12-7.61). To conclude: although most outcomes were similar between devices, evidence was largely based on observational low-quality studies. There were inconsistencies in outcome reporting and definitions; this merits future studies, with head-to-head device comparisons and standardization of outcomes.

Interventions in adults with congenital heart disease (ACHD) focus on surgical and percutaneous interventions in light of rapidly evolving ACHD clinical practice. To bring rigour to our process and amplify the cumulative nature of evidence ACHD care we used the ADAPTE process; we systematically adjudicated, updated, and adapted existing guidelines by Canadian, American, and European cardiac societies from 2010 to 2020. We applied this to interventions related to right and left ventricular outflow obstruction, tetralogy of Fallot, coarctation, aortopathy associated with bicuspid aortic valve, atrioventricular canal defects, Ebstein anomaly, complete and congenitally corrected transposition, and patients with the Fontan operation. In addition to tables indexed to evidence, clinical flow diagrams are included for each lesion to facilitate a practical approach to clinical decision-making. Excluded are recommendations for pacemakers, defibrillators, and arrhythmia-directed interventions covered in separate designated documents. Similarly, where overlap occurs with other guidelines for valvular interventions, reference is made to parallel publications. There is a paucity of high-level quality of evidence in the form of randomized clinical trials to support guidelines in ACHD. We accounted for this in the wording of the strength of recommendations put forth by our national and international experts. As data grow on long-term follow-up, we expect that the evidence driving clinical practice will become increasingly granular. These recommendations are meant to be used to guide dialogue between clinicians, interventional cardiologists, surgeons, and patients making complex decisions relative to ACHD interventions.

Background: The main randomized trials evaluating patent foramen ovale (PFO) closure after a presumed PFO-associated stroke excluded patients older than 60 years. We aimed to evaluate the early- and long-term clinical outcomes of transcatheter PFO closure in older (>60 years) patients with a cryptogenic ischemic event. Methods: This is a multicenter study including consecutive patients older than 60 years (mean age, 67±5 years) who had a PFO closure following a presumed PFO-related ischemic event. Patients ≤60 years old (mean age, 44±10 years) served as the control group. The primary end point was the occurrence of stroke, transient ischemic attack, or peripheral embolism over the follow-up period. New-onset atrial fibrillation was a secondary end point. Results: A total of 388 and 883 patients >60 and ≤60 years old were included, respectively. Procedural success rate was high (99.9%), and procedural-related complications low (P Conclusions: In patients older than 60 years with a presumed PFO-related ischemic event, PFO closure was safe and associated with a relatively low incidence of recurrent ischemic events after a median follow-up of 3 years compared with historical cohorts of patients who did not undergo PFO closure. However, a higher risk of recurrent cerebrovascular events was observed in older patients compared to their younger counterparts. Randomized trials are warranted in this population.

A patent foramen ovale (PFO), present in up to 25% of adults, is an embryologic remnant which allows for right to left shunting and has been implicated in cryptogenic stroke (Neill and Lin, Methodist Debakey Cardiovasc J. 13(3):152–159, 2017; Bass 2015). The current standard of care for selected patients with PFO and cryptogenic stroke is transcatheter closure, but the risk of post-closure, new-onset atrial fibrillation (AF) is unknown (Vaidya et al., Cardiovasc Diagn Ther. 8(6):739–753, 2018; Kjeld et al., Acta Radiol Open. 7(9):2058460118793922, 2018; Staubach et al., Catheter Cardiovasc Interv. 74(6):889–95, 2009). This systematic review and meta-analysis synthesized evidence on AF development post transcatheter PFO closure and predictors of AF development, and assessed existing knowledge gaps. Randomized controlled trials and observational studies were selected according to the inclusion criteria of adults that underwent a transcatheter PFO closure without a history of AF. Studies were retrieved from electronic databases from inception until February 2019. A Freeman-Tukey arcsine transformation was performed for meta-analysis of AF incidence rate. From 765 studies, 45 were included in quantitative data synthesis. Study sample sizes ranged between 20 and 1887 individuals, and average patient age between 37 to 67 years across studies. The overall incidence rate was 0.013 person-years, and 0.014 person-years for the within 6 months follow-up subgroup. There was no consistency in reported predictors of AF development. The incidence of AF post-PFO closure was low across studies, with a high level of between-study heterogeneity. Until a concerted effort is made to improve accurate AF diagnosis, it will be difficult to gauge the association between transcatheter PFO closure and incidence of AF.

Functional mitral regurgitation (MR) is an important clinical consideration in patients with heart failure. Transcatheter edge-to-edge repair (TEER) has emerged as a useful therapeutic tool for patients with chronic heart failure, however the role of TEER in patients with cardiogenic shock (CS) and MR has not yet been studied in a randomized trial. The Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock (CAPITAL MINOS) trial was therefore designed to determine if TEER improves clinical outcomes in the CS population.The CAPITAL MINOS trial is an open-label, multi-center randomized clinical trial comparing TEER to medical therapy in patients with CS and MR. A total of 144 patients with Society for Cardiovascular Angiography and Interventions (SCAI) class C or D CS and at least 3+ MR will be randomized in a 1:1 ratio to TEER or medical therapy alone. The primary outcome will be a composite of in-hospital all-cause mortality, cardiac transplantation, implantation of durable left ventricular assist device, or discharge on palliative inotropic therapy. Patients will be followed for the duration of their index hospitalization for the primary outcome. Secondary outcomes include 6 month mortality.The CAPITAL MINOS trial will determine whether TEER improves outcomes in patients with CS and MR and will be an important step in optimizing treatment for this high-risk patient population.

Background Aortic stenosis (AS) is a common cardiac condition whose prevalence increases with age. The symptom burden associated with severe aortic stenosis (AS) can introduce significant lifestyle disruptions and if left untreated can lead to a poor prognosis. Quality of life (QoL) is an important consideration in these patients. The TASQ is a QoL tool that was developed for aortic stenosis patients. We evaluated the psychometric properties of this specific questionnaire in patients who underwent transcatheter aortic valve implantation (TAVI), which is a therapeutic option for patients with severe aortic stenosis (AS). Methods The properties of the TASQ in measuring QoL were evaluated in AS patients undergoing TAVI. Patients presenting for the TAVI procedure (N = 62) were evaluated pre-TAVI, at discharge, 1-month, and 3-month follow-ups. Demographic information as well as caregiver status, and daily activities were recorded. In addition to the TASQ, they completed the KCCQ (Kansas City Cardiomyopathy Questionnaire) and the IIRS (Illness Intrusiveness Rating Scale). Results The TASQ is a 16-item self-administered questionnaire that assesses AS-specific QoL across five domains: physical symptoms; physical limitations; emotional impact; social limitations, and health expectations. TASQ subscales are internally consistent (α = 0.74–0.96) and showed significant improvements from baseline across assessments (p Conclusions The TASQ is a brief measure of AS-specific QoL that is sensitive to change in patients undergoing TAVI. Items on the TASQ capture important QoL concerns reported by AS patients, suggesting this is a measure of relevant and meaningful outcomes for this patient population. Detection of early improvements in QoL by the TASQ is promising, with important implications for the evaluation of procedural outcomes in this population.

Objectives The aim of this study was to report the 2-year results of the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial and confirm the interim Bayesian analysis. Background Transcatheter aortic valve replacement (TAVR) with a self-expanding valve was noninferior to surgery in patients with severe aortic stenosis and intermediate operative risk using Bayesian statistical methods. Novel Bayesian designs have been used to shorten the time to primary endpoint analysis in randomized clinical trials, although the predictive value of Bayesian analysis compared with frequentist approaches remains debated. Methods The SURTAVI trial randomized 1,660 patients. An interim analysis was performed 1 year after the 1,400th patient was treated to estimate the primary 2-year endpoint of all-cause mortality or disabling strokes for all patients. Results The Kaplan-Meier rate for the complete 2-year primary endpoint was 12.7% in the TAVR group and 12.6% in the surgery group (0.0% difference; 95% confidence interval: −3.4% to 3.5%), compared with 12.6% with TAVR and 14.0% with surgery (−1.4% difference; Bayesian credible interval: −5.2% to 2.3%) in the interim Bayesian analysis. A comparison of individual clinical, hemodynamic, and quality-of-life endpoints using Bayesian and frequentist methods found no significant differences. Conclusions The complete analysis of all patients with aortic stenosis at intermediate risk for surgery in the SURTAVI trial confirmed the noninferiority, with respect to the frequency of all-cause mortality or disabling stroke, of TAVR to surgery, as determined in the interim Bayesian analysis. Follow-up will extend out to 10 years.

Background: Pulmonary hypertension (PH), recently redefined as mean pulmonary arterial pressure >20 mm Hg (PH 20 ), may be observed in patients with atrial septal defects (ASD). We aimed to determine the effect of preprocedural PH 20 status on outcomes among patients undergoing ASD closure. Methods: Study population was selected from a retrospective registry of adult patients who underwent percutaneous ASD closure from 1998 to 2016 from a single center and had right heart catheterizations during the procedure. The clinical registry was linked to administrative databases to capture short- and long-term outcomes. Results: We included a total of 632 ASD closure patients of whom 359 (56.8%) had PH 20 . The mean follow-up length was 7.6±4.6 years. Patients with PH 20 were older (mean age 56.5 versus 43.1 years, P P P 25 ) cutoff, a significantly higher hazard of developing major adverse cardiac and cerebrovascular events was observed in PH versus non-PH patients. Conclusions: ASD patients with PH undergoing closure suffer from more comorbidities and worse long-term major adverse cardiac and cerebrovascular events outcomes, compared with patients without PH. The use of the new PH 20 definition potentially dilutes the effect of this serious condition on outcomes in this population.

Introduction: The association between CAD severity and long-term outcomes in patients admitted with acute HF has not been determined. We characterized the angiographic burden of CAD in patients with acute HF and determined the association between CAD severity and mortality and readmission outcomes. Methods: In a multicenter registry of 70 hospitals in Ontario, Canada, we identified acute HF patients who underwent coronary angiography within 14 days of hospitalization (April 2010-March 2013) using stratified random sampling. We selected a cohort of HF patients with a higher a priori risk of CAD, defined inclusively as those with at least one of the following features: previous myocardial infarction (MI), troponin elevation, or angina on presentation. Using angiographic data, we defined obstructive CAD as the presence of > 70% stenosis in at least one epicardial vessel or > 50% left main (LM) stenosis. Multivessel disease (MVD) was defined as the presence of obstructive disease in 2 or more vessels. We determined adjusted associations between coronary anatomy and the rate of cardiovascular (CV) death and readmissions over two years. Results: Of 1772 patients undergoing angiography who met inclusion criteria (median age 71 [IQR 62-79] years; 38.5% women), 1039 patients had CAD and 683 had MVD. Increasing CAD burden was associated with higher CV death (Figure). CV death was significantly increased in those with any CAD and HFpEF (HR 2.27, 95%CI; 1.12, 4.59, p=0.023). The rate of CV death was increased in MVD (HR 1.91, 95% CI; 1.32, 2.75, p Conclusion: In patients presenting with acute HF, angiographic MVD is associated with an increased rate of CV death and readmissions over 2 years.

Individuals with patent foramen ovale (PFO) routinely undergo transcatheter closure (TC) for secondary prevention of recurrent stroke. However, some evidence suggests that TC may increase the risk of new-onset atrial fibrillation (AF).The purpose of this study was to evaluate the risk of new-onset AF following PFO closure and to explore predictors of AF development.We created a retrospective cohort of all Ontarians over 18 years of age who received TC between October 2002 and December 2017 using administrative health data and the CorHealth cardiac registry. Poisson regression determined event rates of AF and secondary outcomes such as stroke and mortality per 1000 person-years. A multivariable Cox proportional hazards model identified predictors of new-onset AF following TC.Of 1533 patients, 96 (6.26%) developed new-onset AF following PFO closure, over average follow-up time of 8.2 years. Age60 years (hazard ratio [HR] 2.82; 95% confidence interval [CI] 1.76-4.51; P.001) and diabetes (HR 2.49; 95% CI 1.48-4.18; P.001) were statistically significant, independent predictors of AF according to the Cox model.The incidence of new-onset AF after PFO closure was relatively low. Having diabetes and age60 years were the most important factors associated with new-onset AF in this population.

BackgroundComplications and need for reinterventions are frequent in patients with pulmonary valve stenosis (PVS). Pulmonary regurgitation is common, but no data are available on outcome after pulmonary valve replacement (PVR).MethodsWe performed a retrospective analysis of 215 patients with PVS who underwent surgical valvotomy or balloon valvuloplasty. Incidence and predictors of reinterventions and complications were identified. Right ventricle (RV) remodelling after PVR was also assessed.ResultsAfter a median follow-up of 38.6 (30.9–49.4) years, 93% of the patients were asymptomatic. Thirty-nine patients (18%) had at least one PVR. Associated right ventricular outflow tract (RVOT) intervention and the presence of an associated defect were independent predictors of reintervention (OR: 4.1 (95% CI 1.5 to 10.8) and OR: 3.6 (95% CI 1.9 to 6.9), respectively). Cardiovascular death occurred in 2 patients, and 29 patients (14%) had supraventricular arrhythmia. Older age at the time of first intervention and the presence of an associated defect were independent predictors of complications (OR: 1.0 (95% CI 1.0 to 1.1) and OR: 2.1 (95% CI 1.1 to 4.2), respectively). In 16 patients, cardiac magnetic resonance before and after PVR was available. The optimal cut-off values for RV volume normalisation were 193 mL/m2 for RV end-diastolic volume indexed(sensitivity 80%, specificity 64%) and 100 mL/m2 for RV end-systolic volume indexed(sensitivity 80%, specificity 56%).ConclusionsPrevious RVOT intervention, presence of an associated defect and older age at the time of first repair were predictors of outcome. More data are needed to guide timing of PVR, and extrapolation of tetralogy of Fallot guidelines to this population is unlikely to be appropriate.

ObjectiveThe ostium secundum atrial septal defect (ASD) is among the most common congenital cardiac anomalies diagnosed in adulthood. A known complication of transcatheter ASD closure is the development of new-onset atrial fibrillation and flutter (AFi/AFl). These arrhythmias confer an increased risk of postoperative stroke, thrombus formation and systemic emboli. This systematic review examines the burden of de novo AFi/AFl in adults following transcatheter closure and seeks to identify risk factors for AFi/AFl development.MethodsStudies were identified by a search of MEDLINE, EMBASE and Cochrane databases from inception until 29 April 2020. A meta-analysis of AFi/AFl incidence was performed using a random-effects model.ResultsA total of 31 studies met inclusion criteria, comprising 4788 adult patients without a history of AFi/AFl. Twenty-three studies were included in quantitative synthesis and demonstrated an overall incidence rate of 1.82 patients per 100 person-years of follow-up (I2=83%). In studies that enrolled only patients ≥60 years old, the incidence was 5.21 patients per 100 person-years (I2=0%). Studies with follow-up duration ≤2 years reported an incidence of 4.05 per 100 person-years (I2=55%) compared with a rate of 1.19 per 100 person-years (I2=85%) for studies with follow-up duration >2 years.ConclusionsThe incidence of new-onset AFi/AFl is relatively low following transcatheter closure of secundum ASDs. The rate of de novo AFi/AFl, however, was significantly higher in elderly patients. Shorter follow-up time was associated with a higher reported incidence of AFi/AFl.

Objective(s) This study was designed to compare 2 different perioperative analgesia strategies with respect to the incidence of postoperative delirium after a transapical approach for transcatheter aortic valve replacement (TAVR). The authors hypothesized that perioperative thoracic paravertebral analgesia with a local anesthetic would decrease opioid consumption and in turn reduce the incidence of postoperative delirium when compared with systemic opioid-based analgesia after a transapical TAVR procedure. Design Prospective, randomized controlled clinical trial. Setting Tertiary referral center, university hospital. Participants The study comprised 44 patients undergoing a transapical TAVR procedure. Patients with a history of serious mental illness, delirium, and severe dementia and/or patients with contraindications to regional anesthesia were excluded. Interventions Patients were randomly assigned to either the paravertebral group (perioperative continuous thoracic paravertebral block with local anesthetic) or the patient-controlled analgesia group (systemically administered opioids) using a computer-generated randomization code in blocks of four patients. Measurements and Main Results Assessment of postoperative delirium was performed by trained research staff using the confusion assessment method for intensive care unit preoperatively and postoperatively every 12 hours or more often if needed according to the patient's condition during the first 7 postoperative days or until discharge. Pain was assessed with a 10 cm Visual Analog Scale pain score system during the 48 hours postoperatively. The sedation level was assessed using the Sedation Agitation Scale during the same period. Overall postoperative delirium was detected in 12/44 (27%) patients, with 7/22 (32%) in the patient-controlled analgesia and 5/22 (23%) in the paravertebral groups, respectively (p = 0.73). Both groups were similar with respect to demographic data, preoperative medications, and comorbidities. Paravertebral analgesia was associated with an opioid-sparing effect during surgery and during the 48-hour postoperative period. Sedation and pain scores were similar between the 2 groups. In addition, paravertebral analgesia was associated with earlier extubation times; however, the overall morbidity and mortality were similar between the 2 groups. Conclusions Paravertebral analgesia in patients undergoing transapical TAVR procedures appears to have an opioid-sparing effect. However, it did not translate into a statistically significant decrease in the rate of postoperative delirium.

ObjectiveThis study sought to determine the prevalence, predictors, prognostic relevance and evolution of pulmonary hypertension (PH) (mean pulmonary artery pressure ≥25 mm Hg) in adult patients with a subaortic right ventricle (RV) in a biventricular circulation (2V-RV).MethodsWe analysed retrospective data from patients with 2V-RV undergoing cardiac catheterisation in our centre between 2000 and 2018. Echocardiographic assessment of subpulmonary ventricular pressures (left ventricular systolic pressure (LVSP)), age and B-type natriuretic peptide (BNP) were assessed as PH screening tools. Kaplan-Meier curves examined time to a composite outcome of death, transplant or ventricular assist device (VAD). Data from repeat catheterisations were analysed to evaluate PH changes over time, including the effects of therapy.ResultsA total of 141 patients (median age 39 (IQR 33–45) years, 68% men) underwent 191 cardiac catheterisations. At baseline, 55% had PH (isolated postcapillary 24%, combined precapillary and postcapillary 26% and precapillary 5%). BNP (area under the curve 0.80; 95% CI 0.72 to 0.88; pConclusionPH is prevalent in patients with 2V-RV even when asymptomatic. It is difficult to identify by echocardiography and most importantly, is strongly associated with adverse outcomes. PH affects prognosis and transplant options for this patient group and yet is often amenable to treatment. Awareness of these results ought to lower the threshold for invasive haemodynamic assessment and may change the management of failing patients with 2V-RV.

Objectives The authors sought to prospectively determine the safety and efficacy of next-day discharge using the Vancouver 3M (Multidisciplinary, Multimodality, but Minimalist) Clinical Pathway. Background Transfemoral transcatheter aortic valve replacement (TAVR) is an alternative to surgery in high- and intermediate-risk patients; however, hospital stays average at least 6 days in most trials. The Vancouver 3M Clinical Pathway is focused on next-day discharge, made possible by the use of objective screening criteria as well as streamlined peri- and post-procedural management guidelines. Methods Patients were enrolled from 6 low-volume ( 200 TAVR/year) centers in Canada and the United States. The primary outcomes were a composite of all-cause death or stroke by 30 days and the proportion of patients successfully discharged home the day following TAVR. Results Of 1,400 screened patients, 411 were enrolled at 13 centers and received a SAPIEN XT (58.2%) or SAPIEN 3 (41.8%) valve (Edwards Lifesciences, Irvine, California). In centers enrolling exclusively in the study, 55% of screened patients were enrolled. The median age was 84 years (interquartile range: 78 to 87 years) with a median STS score of 4.9% (interquartile range: 3.3% to 6.8%). Next-day discharge home was achieved in 80.1% of patients, and within 48 h in 89.5%. The composite of all-cause mortality or stroke by 30 days occurred in 2.9% (95% confidence interval: 1.7% to 5.1%), with neither component of the primary outcome affected by hospital TAVR volume (p = 0.51). Secondary outcomes at 30 days included major vascular complication 2.4% (n = 10), readmission 9.2% (n = 36), cardiac readmission 5.7% (n = 22), new permanent pacemaker 5.7% (n = 23), and >mild paravalvular regurgitation 3.8% (n = 15). Conclusions Adherence to the Vancouver 3M Clinical Pathway at low-, medium-, and high-volume TAVR centers allows next-day discharge home with excellent safety and efficacy outcomes.

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.

This multisocietal Expert Consensus Systems of Care document was commissioned by the American Association for Thoracic Surgery (AATS), the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS). Expert

The COVID-19 pandemic has necessitated a rapid change in the delivery of healthcare around the world. Many facilities have transitioned suitable services to virtual care to reduce the risk of viral transmission and preserve healthcare resources for spikes in COVID-19 cases. Since institutions have rapidly expanded the usage of virtual care beyond its previous confines, investigations are required to ensure that the adapted system is working for patients. While important, clinical and patient-reported outcome data do not provide complete insight into the specific impacts of pandemic-time changes from the patient’s perspective. Therefore, to get a complete picture of these changes, it is also necessary to look at patient experience, which evidence suggests, could be impacted by virtual care in positive ways, but only in specific cases. Thus, it is vital to record pandemic-time patient experiences and analyse how the implementation of virtual visits impacts the delivery of person-centred care. This data should be used to determine how virtual care can be optimally implemented into the Canadian healthcare system after the resolution of the COVID-19 pandemic. Although it is currently unclear how virtual care will be integrated into the post-pandemic landscape, the approach offers benefits to both patients and providers. Canada-wide, longitudinal studies investigating patient experience using virtual care during the COVID-19 pandemic are required in order to ascertain exactly how this novel approach can be leveraged to benefit patients.

A patent foramen ovale (PFO), present in up to 25% of adults, is an embryologic remnant which allows for right to left shunting and has been implicated in cryptogenic stroke (Neill and Lin, Methodist Debakey Cardiovasc J. 13(3):152-159, 2017; Bass 2015). The current standard of care for selected patients with PFO and cryptogenic stroke is transcatheter closure, but the risk of post-closure, new-onset atrial fibrillation (AF) is unknown (Vaidya et al., Cardiovasc Diagn Ther. 8(6):739-753, 2018; Kjeld et al., Acta Radiol Open. 7(9):2058460118793922, 2018; Staubach et al., Catheter Cardiovasc Interv. 74(6):889-95, 2009). This systematic review and meta-analysis synthesized evidence on AF development post transcatheter PFO closure and predictors of AF development, and assessed existing knowledge gaps.Randomized controlled trials and observational studies were selected according to the inclusion criteria of adults that underwent a transcatheter PFO closure without a history of AF. Studies were retrieved from electronic databases from inception until February 2019. A Freeman-Tukey arcsine transformation was performed for meta-analysis of AF incidence rate.From 765 studies, 45 were included in quantitative data synthesis. Study sample sizes ranged between 20 and 1887 individuals, and average patient age between 37 to 67 years across studies. The overall incidence rate was 0.013 person-years, and 0.014 person-years for the within 6 months follow-up subgroup. There was no consistency in reported predictors of AF development.The incidence of AF post-PFO closure was low across studies, with a high level of between-study heterogeneity. Until a concerted effort is made to improve accurate AF diagnosis, it will be difficult to gauge the association between transcatheter PFO closure and incidence of AF.

IMPORTANCE: Adding clopidogrel to aspirin for 3 months after transcatheter atrial septal defect (ASD) closure results in a lower incidence of new-onset migraine attacks. However, the outcomes at 6- to 12-month follow-up (after clopidogrel cessation at 3 months) remain largely unknown. OBJECTIVE: To assess the incidence of migraine attacks at 6- and 12-month follow-up after transcatheter ASD closure. DESIGN, SETTING, AND PARTICIPANTS: This prespecified analysis of a randomized, double-blind clinical trial included patients with no prior history of migraine undergoing ASD closure from 6 university hospitals in Canada from December 2008 to November 2014. Patients were followed up at 3, 6, and 12 months, and a migraine headache questionnaire was administered at each time. Analysis began June 2019. INTERVENTIONS: Patients were randomized (1:1) to receive dual antiplatelet therapy (aspirin plus clopidogrel; n = 84) vs single antiplatelet therapy (aspirin plus placebo; n = 87) for 3 months following transcatheter ASD closure. After 3 months, only single antiplatelet therapy (aspirin) was pursued. MAIN OUTCOMES AND MEASURES: Incidence and severity of migraine attacks at 6- and 12-month follow-up. RESULTS: The mean (SD) age of the study population was 38 (12) years, with 106 women (62%). A total of 27 patients (15.8%) had new-onset migraine attacks within the 3 months following ASD closure (8 of 84 [9.5%] vs 19 of 87 [21.8%] in the initial clopidogrel and placebo groups, respectively; P = .03). After cessation of clopidogrel and aspirin monotherapy, the percentage of patients with migraine attacks decreased over time, with 8 (4.7%) and 4 patients (2.3%) continuing to have migraine attacks at 6 and 12 months, respectively (vs 3 months: P

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.ASD is the second most common lesion in congenital heart disease. Comprehensive data on long-term outcomes after ASD closure are limited.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.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% were60 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 the60 years of age group than in the younger groups. In adjusted analysis, patients60 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.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.

BackgroundAtrial septal defect (ASD) is a common form of congenital heart disease. Significant shunts may increase the risk of developing pulmonary hypertension (PH). We aimed to describe current PH definitions, evaluate PH prevalence and the effect of PH on outcomes in patients undergoing percutaneous ASD closure.MethodsEMBASE, MEDLINE and Cochrane databases were systematically searched. Studies reporting PH prevalence or mean systolic pulmonary arterial pressure (sPAP) before and after percutaneous ASD closure in adults were included. We conducted meta-analyses to obtain summary estimates for PH prevalence and mean sPAP.Results15 articles with a total of 1073 patients met the eligibility criteria. Studies applied variable PH definitions. PH prevalence and mean sPAP levels decreased in all studies after closure. The pooled PH prevalence decreased from 44% (95% CI 29–60%) to 18% (95% CI 8–27%). The overall standardised mean difference in sPAP was 1.12 (95% CI 0.81–1.44) and 1.62 (95% CI 1.00–2.23) in cohort and case-series studies respectively indicating a large decrease. The pooled standard mean difference among the younger and older patients were different, 1.25 (95% CI 0.78–1.71) and 0.91 (95% CI 0.56–1.27), respectively. A high degree of between-study heterogeneity was noted.ConclusionsBoth PH prevalence and mean sPAP decrease after ASD closure. Larger, prospective studies with consistent PH definitions using the recommended measurement modality are warranted.

Transcatheter atrial septal defect closure (TAC) is a well-established therapy for most patients with secundum atrial septal defects (ASD) based on short-term data ([1][1]). In previous surgical studies, mortality was not significantly different from age-and-sex matched control subjects ([2][2]).

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.

Background Twenty percent of patients born with congenital heart disease present with right ventricular outflow tract abnormalities. These patients require multiple surgical procedures in their lifetime. Transcatheter pulmonary valve replacement (TPVR) has become a viable alternative to conventional pulmonary valve and right ventricular outflow tract surgery in pediatric and adult populations. In this retrospective review, we analyze the perioperative management of adult patients who underwent TPVR in our center. Methods The study consisted of a chart review of patients who underwent TPVR at Toronto General Hospital between 2006 and 2015. Information about preoperative assessment, intraoperative anesthetic management, and intra- and postprocedural complications was collected. Two types of percutaneous valves have been used for a conduit or valve size between 16 and 28 mm. These procedures are done via the femoral, jugular, or subclavian vein under general anesthesia. Results Seventy-nine adults (17-68 years of age) who underwent elective TPVR procedures were included. General anesthesia was used in all cases. Defibrillation was necessary in 1 case, and bradycardia was spontaneously resolved in another 1. Eighty-five percent were successfully extubated at the end of the procedure. Five patients required intraoperative inotropic support. Three patients presented self-resolved hemoptysis. Mechanical ventilation for >24 hours was necessary in 3 cases, 2 of which also required concomitant inotropic support. Four failed deployments and 1 case of persistent conduit stenosis were reported. Three patients required reintubation. All patients were discharged home. Conclusions Patients undergoing TPVR represent a complex and heterogeneous population. General anesthesia with endotracheal intubation is preferred. Setup for urgent lung isolation and cardiac defibrillation should be considered. Postoperative monitoring and intensive care setting are required. Anesthesiologists with cardiac anesthesia training are probably better suited to manage these patients.

Objective Although heart failure (HF) is the leading cause of premature death in adult congenital heart disease (ACHD), little population-specific data exist. This study reports early experience from a dedicated, sub-specialty adult congenital heart disease-heart failure (ACHD-HF) clinic, aiming to identify risk factors for adverse outcome. Methods Between 2012 and 2015, 126 patients (57% male) attended the ACHD-HF clinic. Baseline and follow-up data were analysed and compared across 4 anatomical/physiological subgroups: cyanotic ACHD, Fontan circulation (1V), biventricular circulation with a subaortic right ventricle (2V-RV) and biventricular circulation with a subaortic left ventricle (2V-LV). Predictors of the composite primary outcome: death, transplant or ventricular assist device (VAD) were identified using multivariable Cox proportional hazard models. Results Mean age at first visit was 38±13years. Patients were grouped as follows: cyanotic ACHD 10%, 1V 24%, 2V-RV 29% and 2V-LV 37%. During a median follow-up of 1.7 (IQR 0.8–2.9) years, 38 patients (30%) reached the primary outcome. Event-free survival was 89%, 78% and 63% at 1, 2 and 3years. Forty (31.7%) patients experienced 69 HF hospitalisations. Between-group differences were noted for systolic function, valvular regurgitation, pacing prevalence and invasive hemodynamics. Multivariable analysis revealed 2V-RV subgroup ( p =0.001), NYHA class ( p =0.002) B-type natriuretic peptide >164pg/ml ( p =0.003) and sodium p =0.036) as independently associated with death, transplant or VAD. Conclusions Our young ACHD-HF patients experienced high adverse event rates during a short period of follow-up. The prognostic markers identified will aid clinicians to stratify short-term risk and thereby guide advanced HF management decisions in ACHD.

Tetralogy of Fallot repair (rTOF) typically involves remodeling of the right ventricular (RV) outflow tract (RVOT) and augmentation of pulmonary arteries (PAs). Percutaneous pulmonary valve implantation (PPVI) procedures are well-established within pre-existing RV-to-PA conduits or bioprosthetic

Background Anomalous origin of a coronary artery from the pulmonary artery (PA) is a rare condition that usually presents in childhood. The aim of this study is to describe its characteristics in unrepaired adults. Methods We conducted a retrospective study of 18 patients with left and right anomalous coronary artery from the PA (ALCAPA and ARCAPA) diagnosed in adulthood. Patients ≥18 years old at diagnosis and assessed at least once in our institution were included. Results Median age at diagnosis was 29.5 years [IQR 24.0–48.8]. Presentation mode varied, with two patients (11%) diagnosed following aborted sudden cardiac death. Diagnosis was most frequently made by coronary angiography (44%) and cardiac computed tomography (28%). The mean left ventricle ejection fraction (LVEF) at presentation was 56 ±10% and moderate or severe mitral regurgitation was present in 5 patients. Surgical or interventional repair was performed in 14 patients (78%), 9 of whom (50%) underwent reimplantation. Median follow-up was 8.5 years [IQR 0.98–13.8]. One patient with severe pulmonary hypertension died during the follow-up. Most patients (79%) were in NYHA functional class 1 at last follow-up with a mean LVEF of 53±12%. Conclusions Anomalous origin of a coronary artery from the PA can present in adulthood in various ways. Multimodality imaging allows the diagnosis and assessment of functional impact. Surgical correction of ALCAPA with establishment of a dual coronary pathway was the most frequent management strategy in our cohort. The majority of patients experienced favorable long-term outcomes.

This early feasibility study was designed to obtain in vivo data to confirm assumptions on device loading conditions of the Medtronic Harmony transcatheter pulmonary valve (TPV). Secondary objectives included procedural feasibility, safety, and valve performance. The Harmony TPV was developed for nonsurgical pulmonary valve replacement in non-right ventricle-pulmonary artery conduit patients. The Native Outflow Tract TPV Research Clinical Study was the first study approved under the Food and Drug Administration Early Feasibility Study guidance. Enrollment required that patient anatomy be precisely matched to the single-size Harmony TPV implant, necessitating a rigorous selection process. The study was nonrandomized, prospective, and performed at 3 sites. All patients met standard indications for surgical pulmonary valve replacement. The goal of the screening committee was to match the candidate anatomy to predetermined engineering criteria thought to be predictive of secure Harmony TPV implantation for the single-size device under study. A majority of the screening committee was required to recommend a patient as eligible for implant. A total of 270 patients underwent prescreening cardiac magnetic resonance imaging, 66 were enrolled and received a computed tomography scan (24%), 21 met criteria for implant and were catheterized (8%), and 20 underwent implant. Nineteen of 20 met criteria for implant success. In conclusion, the Medtronic Harmony TPV represents an emerging therapeutic option for patients with complex postoperative right ventricular outflow tract failure. The initial clinical evaluation of this technology was unique, and the highly variable anatomy of this population required careful screening to ensure acceptable device fit.

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.

Background Left atrial (LA) size is a marker of prognosis in severe aortic stenosis (AS). The aims of this retrospective study were to assess the impact of transcatheter aortic valve implantation (TAVI) on the recovery of LA phasic function and to assess the relationship between LA function and new-onset atrial fibrillation (NAF) after TAVI. Methods In this retrospective cohort study, LA function was measured using biplane volumes and 2-dimensional (2D) speckle tracking echocardiography (STE) in 52 patients (median age, 81 years) with severe AS before TAVI and at midterm follow-up. Twenty healthy individuals ≥ 75 years were used as controls. Results Before TAVI, the 3 phasic volumetric emptying fractions and all STE-derived parameters of LA function were significantly reduced. At 5 ± 3 months after TAVI, there was an improvement in LA reservoir and contractile function. However, LA phasic volumes and emptying fractions showed minimal changes. Fourteen patients had NAF in the early postprocedural period after TAVI. These patients experienced longer hospitalization (11 days vs 6 days; P = 0.002). By bivariable logistic regression analysis, the use of a transapical approach and the LA early diastolic strain rate (SR) before TAVI were significantly associated with NAF immediately after TAVI. Conclusions Severe AS is associated with LA dysfunction. Intrinsic LA compliance and LA contractile properties by STE improved at midterm follow-up after TAVI. Preprocedural LA early diastolic SR may predict the development of NAF after TAVI pending confirmation by larger prospective evaluations.

Objectives To report the initial clinical experience with a novel atrial septal defect (ASD) closure device, the GORE® CARDIOFORM ASD Occluder (GCO). Background Transcatheter closure has become the treatment of choice for secundum ASD. A wide range of occluder devices are available, but concern has been raised about the risk of cardiac erosion associated with rigid devices and future access to the left atrium Methods Retrospective chart review of patients treated with the GCO at three Canadian centers. Primary outcomes were procedural success and residual shunting at follow-up, as well as 30-day major adverse events. Secondary outcomes included new onset atrial arrhythmias, wire frame fractures (WFF), and all cause mortality. Clinical, echocardiographic, procedural data, and follow-up outcome variables were collected in each participating hospital. Results Between February and December 2015, 26 patients (5 children and 21 adults) underwent transcatheter ASD closure with the GCO and were included in the study cohort. Procedural success was achieved in 22 of 26 patients (85%) and no major procedural complications were observed. Two patients (8%) presented new onset atrial tachyarrhythmia during early follow-up (0–30 days). Follow-up echocardiography (median of 119 days [IQR: 92–146]) demonstrated no residual shunt in all implanted patients. After a median clinical follow-up of 174 days (IQR: 135–239), one patient died of an unrelated cause, there were no documented major adverse cardiovascular events. Fluoroscopic imaging of the device was performed in 20 patients (91%), and WFF was noted in five cases. No clinical consequence or device dysfunction was observed in these patients. Conclusions In this first-in-man multicenter study, the GCO was safe and effective for ASD closure, with no major adverse events or residual shunt at follow-up. © 2017 Wiley Periodicals, Inc.

Advances in catheter-based interventions in structural and congenital heart disease have mandated an increased demand for three-dimensional (3D) visualisation of complex cardiac anatomy. Despite progress in 3D imaging modalities, the pre- and periprocedural visualisation of spatial anatomy is relegated to two-dimensional flat screen representations. 3D printing is an evolving technology based on the concept of additive manufacturing, where computerised digital surface renders are converted into physical models. Printed models replicate complex structures in tangible forms that cardiovascular physicians and surgeons can use for education, preprocedural planning and device testing. In this review we discuss the different steps of the 3D printing process, which include image acquisition, segmentation, printing methods and materials. We also examine the expanded applications of 3D printing in the catheter-based treatment of adult patients with structural and congenital heart disease while highlighting the current limitations of this technology in terms of segmentation, model accuracy and dynamic capabilities. Furthermore, we provide information on the resources needed to establish a hospital-based 3D printing laboratory. Electronic supplementary material The online version of this article (doi: 10.1007/s12471-016-0942-3) contains supplementary material, which is available to authorized users.