OBJECTIVE:Balloon pulmonary angioplasty (BPA) is frequently used in chronic thromboembolic pulmonary hypertension (CTEPH)/chronic thromboembolic pulmonary disease (CTED). Nevertheless, noninvasive pulmonary perfusion imaging after BPA is scarce. In this study, change in perfusion on ventilation/perfusion (V/Q) scan after BPA was assessed and correlated with clinical outcomes. METHODS:Retrospectively, all consecutive patients with CTEPH/CTED patients who completed BPA and received planar V/Q scans baseline and 6 months follow-up were included. Perfusion was evaluated using gestalt interpretation and semiquantitative calculation of the pulmonary vascular obstruction (PVO) index, with obligatory use of the lung segment reference chart. Interobserver variability was assessed for both methods, and the correlation between PVO index and clinical parameters was tested. RESULTS:Thirty-three patients with CTEPH/CTED (mean age: 60.4 ± 14.7 years, 70% female) underwent 127 BPA procedures. Gestalt interpretation showed improved perfusion in 79% of all patients, and PVO index decreased significantly compared with baseline (45 ± 15-35 ± 15%; P < 0.001). The gestalt method showed a weak level of agreement ( k = 0.32; P = 0.06), and the PVO method showed a moderate to strong reliability ( R2 : 0.71, P < 0.001). The PVO index showed a significant ( P < 0.001) but weak correlation with log N-terminal probrain natriuretic peptide, mean pulmonary artery pressure, and pulmonary vascular resistance ( R2 : 0.26, 0.24, and 0.18, respectively). CONCLUSION:Perfusion on V/Q scan significantly improved after BPA in patients with CTEPH/CTED. Semiquantitative calculation of PVO was more reliable in comparison to gestalt interpretation, however, clinical parameters showed only a weak correlation with the PVO index.
Rationale: Pulmonary Hypertension (PH) is a chronic and progressive cardio-pulmonary disease. Patients with PH are likely to have worse nutritional status. Malnutrition is associated with a lower QoL. However, fluid retention complicates weight-based malnutrition screening in PH patients. Therefore, the aim is to determine the diagnostic accuracy of MUST and MNA-SF for malnutrition in pulmonary hypertension (PH) in order to determine the most accurate screening method. Methods: This cross-sectional single centre study included Dutch or English speaking, adult PH outpatients of the Sint Antonius Hospital. Patients who were pregnant, had electrical implants, treatment policy focused on comfort, status after pulmonary endarterectomy or without PH specific medication were excluded. Bioelectrical impedance vector analyses was used to measure muscle mass. MUST and MNA-SF data were compared with the GLIM criteria as golden standard for nutritional status. Sensitivity, specificity and area under the curve (AUC) are calculated. Results: 23% of the PH outpatients were malnourished according to GLIM criteria. Sensitivity for both MUST and MNA appeared to be 60% and specificity was 97% for MUST and 82% for MNA. The area under the curve (AUC) was 0,70.Tabled 1MUST (%)MNA-SF (%)Sensitivity6161Specificity9782Positive predictive value8550Negative predictive value8976 Open table in a new tab Conclusion: MUST and MNA-SF are fair for identifying (risk of) malnutrition among PH outpatients. However, due to the low sensitivity rate (60%) of both screening tools it might be considered to directly determine nutritional status of PH outpatients with the GLIM criteria. Disclosure of Interest: None declared
Abstract Introduction Diagnostic work-up of patients with an anomalous aortic origin of a coronary artery (AAOCA) includes an anatomical and functional assessment. The approach to functional evaluation currently varies widely and mainly includes noninvasive assessment. Intracoronary hemodynamic assessment can potentially enhance risk assessment for myocardial ischemia and sudden cardiac death and guide management of AAOCA patients. Hence, this study aims to evaluate invasive detection of ischemia on top of the standard of care diagnostic work-up for interarterial or intraseptal AAOCA and the impact on patient management. We report the first clinical outcomes. Methods In this multicenter prospective cohort study on AAOCA, all consecutive patients of 16 years and older with AAOCA with a newly diagnosed interarterial or intraseptal course in whom diagnostic work-up according to the protocol of the MuSCAT trial was performed between January 2021 and January 2024, were included for analysis. Exclusion comprised incomplete diagnostic evaluation, hemodynamically significant concomitant congenital heart disease or obstructive coronary artery disease in the AAOCA effluence. The work-up included invasive ischemia testing using fractional flow reserve (FFR) and or instantaneous wave-free ratio (iFR)/resting full-cycle ratio (RFR) at baseline and during pharmacological stress using adenosine, adrenaline and dobutamine. Results Fifty-eight patients (50% female, median age at AAOCA diagnosis 51.5 years (IQR 44.0-59.0)) were included, Table 1. The right coronary artery was anomalous in 88%, 93% patients had an interarterial and 69% an intramural course. Non-invasive ischemia detection was positive in 12%, negative in 84% and inconclusive in 4%. Invasive hemodynamic assessment was positive for ischemia in 22%, negative in 74% and inconclusive in 3%. Class of recommendation for surgery based on ESC guidelines was I or IIa in 28% patients and IIb, III or unclassified in 72%. Invasive hemodynamic assessment changed the treatment decision in 24% of the patients; 50% with initially recommended surgical treatment and 14% with initially a conservative treatment adjudication, Figure 1. Median follow-up after initial diagnosis was 20 [IQR 10-28] months and in 56% of all patients who completed 6 months follow-up the initial symptoms alleviated. One (2%) patient underwent a percutaneous re-intervention of the operated AAOCA. Conclusions This national prospective study of invasive hemodynamic assessment in patients with AAOCA showed clinically significant impact on the adjustment of initial management strategy in 24% of the patients. No cardiac death of myocardial infarction in the AAOCA supply area occurred during follow-up. Analysis of the complete follow-up of the MuSCAT trial can further substantiate the role of additional invasive functional imaging in AAOCA.
Therapies for inoperable chronic thromboembolic pulmonary hypertension (CTEPH) include balloon pulmonary angioplasty (BPA) and PH-specific medical therapy. This study compares survival and its predictors before and after the introduction of BPA. BPA was independently associated with survival; however, there was no difference in overall survival between the two cohorts.
AIMS:Systemic sclerosis (SSc) is characterized by vasculopathy, inflammation, and fibrosis, and carries one of the worst prognoses if patients also develop pulmonary arterial hypertension (PAH). Although PAH is a known prognosticator, patients with SSc-PAH demonstrate disproportionately high mortality, presumably due to cardiac involvement. In this cross-sectional study, the relationship between cardiac involvement revealed by cardiovascular magnetic resonance (CMR) and systemic microvascular disease severity measured with nailfold capillaromicroscopy (NCM) in patients with SSc-PAH is evaluated and compared with patients with idiopathic PAH (IPAH). METHODS AND RESULTS:Patients with SSc-PAH and IPAH underwent CMR, echocardiography, and NCM with post-occlusive reactivity hyperaemia (PORH) testing on the same day. CMR imaging included T2 (oedema), native, and post-contrast T1 mapping to measure the extracellular volume fraction (ECV, fibrosis) and adenosine-stress-perfusion imaging measuring the relative myocardial upslope (microvascular coronary perfusion). Measures of peripheral microvascular function were related to CMR indices of oedema, fibrosis, and myocardial perfusion. SSc-PAH patients (n = 20) had higher T2 values and a trend towards a higher ECV, compared with IPAH patients (n = 5), and a lower nailfold capillary density (NCD) and reduced capillary recruitment after PORH. NCD correlated with ECV and T2 (r = -0.443 and -0.464, respectively, P < 0.05 for both) and with markers of diastolic dysfunction on echocardiography. PORH testing, but not NCD, correlated with the relative myocardial upslope (r = 0.421, P < 0.05). CONCLUSION:SSc-PAH patients showed higher markers of cardiac fibrosis and inflammation, compared with IPAH patients. These markers correlated well with peripheral microvascular dysfunction, suggesting that SSc-driven inflammation and vasculopathy concurrently affect peripheral microcirculation and the heart. This may contribute to the disproportionate high mortality in SSc-PAH.
Background: In order to prevent right ventricular (RV) dysfunction, closure of secundum type atrial septal defects (ASD) is often indicated and percutaneous closure is the preferred treatment modality to do so. The magnitude and time course of RV remodeling is still incompletely understood. Methods: This retrospective cohort study included consecutive patients who underwent percutaneous secundum ASD closure in two tertiary referral centers in The Netherlands. Main study parameters were RV and right atrial dimensions measured with transthoracic echocardiography before and after percutaneous ASD closure. Secondary outcome was change in New York Heart Association (NYHA) functional class at follow-up. Results: From the 454 patients who underwent secundum ASD closure, 88 patients (median age 46 [range 17-84]) were included. The majority of RV and right atrial dimensional improvement occurred within 24 h. After a median follow-up of 569 days (IQR: 280-772) a further decrease in dimensions was observed. Comparing baseline and latest follow-up, end-diastolic RV basal diameter decreased from 4.5 SEM 0.1 to 3.9 SEM 0.1 cm (p < 0.001) and end-systolic right atrial area from 22.9 SEM 1.0 to 17.9 SEM 0.7 cm(2) (p < 0.001). No significant changes in RV function were observed. NYHA functional class improved from 1.5 at baseline (IQR: 1.0-2.0) to 1.0 (IQR: 1.0-1.5) at latest follow-up (p < 0.001). Conclusion: Remodeling of the RV heart dimensions commences within 24 h after percutaneous secundum ASD closure for the majority of patients, followed by a further gradual recovery. A concurrent improvement of NYHA functional class was observed during follow-up.
Haploinsufficiency for Endoglin (ENG) and activin A receptor type II-like I (ACVRL1/ALK1) lead to the formation of weak and abnormal vessels in hereditary hemorrhagic telangiectasia (HHT). These cause epistaxis (nosebleeds) and/or gastrointestinal blood loss. In vitro in cultured endothelial cells, tacrolimus has been shown to increase ENG and ALK1 expression. It is, therefore, a potential treatment option. We report here a proof-of-concept study in patients with HHT and severe epistaxis and/or gastrointestinal bleeding who were treated daily with orally-administered tacrolimus for twenty weeks. Twenty-five patients with HHT (11 females (44%)) and median age of 59 years were enrolled. Five patients (20%) stopped the trial prematurely-four due to (serious) adverse events ((S)AE). Twenty patients were included in further analyses. Hemoglobin levels increased during tacrolimus treatment from 6.1 (IQR 5.2–6.9) mmol/L at baseline (9.8 g/dL) to 6.7 (6.5–7.1) mmol/L (10.8 g/dL), p = 0.003. The number of blood transfusions over the twenty weeks decreased from a mean of 5.0 (±9.2) to 1.9 (±3.5), p = 0.04. In 64% of the patients, at least one AE occurred. Oral tacrolimus, thus, significantly increased hemoglobin levels and decreased blood transfusion needs, epistaxis and/or gastrointestinal bleeding in patients with HHT. However, side-effects were common. Further investigation of the potential therapeutic benefit is justified by the outcome of the study.
We aimed to evaluate the safety and efficacy of non-vitamin K antagonist oral anticoagulants (NOACs) in adults with congenital heart disease (CHD) who underwent a pulmonary valve replacement (PVR). This is an international, multicenter, prospective study using data from the NOTE registry. All adults with a history of PVR taking NOACs constituted our study population. Follow-up took place at 6 months and yearly thereafter. The primary endpoint were thromboembolic (TE) events and major bleeding (MB). The secondary endpoint was minor bleeding. From January 2013 to June 2021, 29 patients (median age 52 years, interquartile range [43–58], 58% male) with a history of PVR (59% moderately and 31% severely complex CHD) on NOACs were included in the NOTE registry and constituted our study population. Atrial arrhythmia was the exclusive indication for anticoagulant therapy. During a median follow-up of 2 years (IQR 0.8–3.2), no patient experienced TE event. One MB (3.5%) which led to death and 6 minor bleedings (20.7%) occurred on NOACs alone (Fig. 1). The annual incidence rate was 1.6% (95% CI 0.04 to 9.2%) for MB and 8.4% (96% CI 2.7 to 19.6%) for minor bleeding. The overall survival free from TE and MB was 100% and 87.5% respectively at 2.5 years of follow-up. Three invasive cardiac procedures, including 2 percutaneous PVR, were safely performed during the follow-up. On univariate analysis, increase in BLED score (HR 3.5; 95% CI 1.2–10.2, P = 0.02) and female gender (HR (male) 0.08; 95% CI 0.01–0.7; P = 0.02) were predictive factors of bleeding. This prospective study demonstrated excellent efficacy of NOACs at mid-term in patients with CHD and PVR, but suggested an increased risk of bleeding, particularly in women and patients with high BLED score.
The physiological changes during pregnancy predispose a woman for the development of new-onset or recurrent arrhythmia. Supraventricular arrhythmia is the most common form of arrhythmia during pregnancy and, although often benign in nature, can be concerning. We describe three complex cases of supraventricular arrhythmia during pregnancy and review the currently available literature on the subject. In pregnancies complicated by arrhythmia, a plan for follow-up and both maternal and fetal monitoring during pregnancy, delivery and post partum should be made in a multidisciplinary team. Diagnostic modalities should be used as in non-pregnant women if there is an indication. All antiarrhythmic drugs cross the placenta, but when necessary, medical treatment should be used with consideration to the fetus and the mother’s altered pharmacodynamics and kinetics. Electrical cardioversion is safe during pregnancy, and electrophysiological study and catheter ablation can be performed in selected patients, preferably with zero-fluoroscopy technique. Sometimes, delivering the fetus (if viable) is the best therapeutic option. In this review, we provide a framework for the workup and clinical management of supraventricular arrhythmias in pregnant women, including cardiac, obstetric and neonatal perspectives.
BACKGROUND:Risk stratification for sudden cardiac death (SCD) in cardiac sarcoidosis (CS) is challenging in patients without overt cardiac symptoms. OBJECTIVE:The purpose of this study was to determine the incidence of ventricular arrhythmias (VAs) and mortality after long-term monitoring with a cardiovascular implantable electronic device (CIED) in CS patients identified after systematic screening of patients with extracardiac sarcoidosis (ECS). METHODS:A retrospective study was performed in 547 predominantly Caucasian patients with ECS screened for cardiac involvement. If CS was diagnosed, risk stratification (high vs low risk) for SCD was performed by a multidisciplinary team. The primary endpoint was defined as sustained VA, appropriate implantable cardioverter-defibrillator (ICD) therapy, or cardiac death. RESULTS:In total, 105 patients were included (mean follow-up 33 ± 16 months). An ICD was implanted in 17 high-risk patients (16.2%), whereas 80 low-risk patients (76.1%) received an implantable loop recorder (ILR). Eight low-risk patients (7.6%) did not receive a device. The primary endpoint occurred in 4.8% (n = 5), with an overall annualized event rate of 1.7%. The annualized event rate was 9.8% in high-risk patients and 0.4% in low-risk patients. Nine low-risk patients received an ICD during follow-up, in 7 patients as a result of the ILR recordings. None of these patients required ICD therapy. CONCLUSION:In CS patients without overt cardiac symptoms at initial presentation the annualized overall event rate was 1.7%; 10% in high-risk patients, but only 0.4% in low-risk patients. In low-risk patients long-term arrhythmia monitoring with an ILR enabled early detection of clinically important arrhythmias without showing impact on prognosis.
We report a patient with transient loss of consciousness preceded by hallucinations caused by cardiac syncope. The diagnosis was confirmed by simultaneous video-electrocardiogram-electroencephalogram recording of an event. The attacks no longer occurred after pacemaker implantation. Clinical features helpful in guiding decision making in transient loss of consciousness are discussed. (Level of Difficulty: Beginner.)
Hereditary hemorrhagic telangiectasia (HHT), an autosomal dominant disease, is characterized by telangiectases and arteriovenous malformations (AVMs). Untreated AVMs, especially in the lungs—pulmonary AVMs (PAVMs)—can result in morbidity with a decreased life expectancy. We have investigated whether HHT patients, systematically screened for HHT-related organ involvement and treated if needed, have a similar survival as persons without HHT. We included all individuals screened for HHT between 2004 and 2016 with a genetically or clinically confirmed diagnosis (HHT group) or excluded diagnosis (non-HHT control group). The social security number was used to confirm status as dead or alive in December 2019. We included 717 HHT patients and 471 controls. There was no difference in survival between the HHT and the non-HHT control group. The HHT group had a life expectancy of 75.9 years (95% confidence interval (CI) 73.3–78.6), comparable to the control group (79.3 years, 95% CI 74.8–84.0, Mantel–Cox test: p = 0.29). In conclusion, the life expectancy of HHT patients systematically screened for HHT-related organ involvement and treated if needed in an HHT center of excellence was similar compared to their controls, justifying systematic screening and treatment in HHT patients.
Abnormal vasculature is a key feature of hereditary hemorrhagic telangiectasia (HHT) and can also present in the nail fold capillary beds. However, the exact prevalence and the clinical diagnostic value in HHT are still largely unknown. The nail fold can be easily and noninvasively inspected with a capillary microscope. We therefore retrospectively assessed the prevalence and diagnostic value of abnormal nail fold capillaries in all patients who were screened between January 2000 and July 2017 for the presence of HHT and underwent capillary microscopy in St Antonius Hospital, The Netherlands. Capillary microscopy results and clinical characteristics were extracted from medical files and the prevalence of abnormal nail fold capillaries was calculated and the diagnostic value of the Curaçao criteria with and without capillary microscopy results was assessed. Of the 1761 individuals screened, 923 (52%) were diagnosed with a clinical and/or genetic HHT diagnosis. In these patients, capillary microscopy was normal in 23% (n = 218), enlarged loops were seen in 11% (n = 99), and giant loops in 66% (n = 606). The sensitivity and specificity of the Curaçao criteria for the diagnosis of HHT without capillary microscopy results were 96% and 90%, respectively. The addition of the presence of giant loops to the Curaçao criteria led to a small increase in sensitivity to 97% without affecting the specificity. In conclusion, the prevalence of nail fold abnormalities in patients with HHT is high. Capillary microscopy can be a useful, easy, and noninvasive diagnostic tool in HHT.
Abstract Background Recently, selexipag, a new orally available and selective prostacyclin receptor agonist, has become available for treatment of pulmonary arterial hypertension (PAH), but experience in patients with PAH associated with congenital heart disease (CHD) is limited to patients with closed defects. Purpose We present our early multi-centre experience using selexipag in the heterogeneous PAH-CHD population. Methods We prospectively evaluated adults with PAH-CHD from five PAH-CHD expert centres who were treated with selexipag. Patients were titrated to highest tolerable individualized dose (200 to 1,600 μg twice daily), after which patients entered the maintenance phase. Data on functional class (FC), 6-minute walk distance (6MWD), imaging and biochemical (N terminal pro-brain natriuretic peptide [NT-proBNP]) parameters were collected. Results Thirty-four patients (age 43±14 years, 56% female, 60% Eisenmenger syndrome, 22% Down syndrome, 60% dual PAH therapy) were started on selexipag. All patients experienced at least 2 side effects during the initial uptitration phase. Most side effects were manageable and diminished after reaching the maintenance dose, but eight patients discontinued treatment due to side effects during the titration phase. The most frequent side effects were consistent with the known side effects of prostacyclins, including headache, nausea, diarrhoea and jaw pain. Majority (68%) of patients reached lower maintenance doses of 200–600 μg. At 12 months, FC improved in three patients and remained unchanged in the others. 6-minute walk distance remained stable throughout follow-up (475 to 470 m; p=n.s.) in patients who remained on-treatment compared to patients who stopped selexipag (485 to 370 m). NT-proBNP levels remained stable in patients on-treatment (520 to 600 ng/L) but worsened in patients who stopped (700 to 1000 ng/L). One patient died during follow-up from end-stage heart failure. Conclusion There is a promising role for selexipag in the treatment of adults with PAH-CHD. However, based on our experience, the use is challenging due to complexity in dosing and side effect profiles, which limit patients' tolerability and acceptance during the titration phase. Funding Acknowledgement Type of funding source: Other. Main funding source(s): Actelion Pharmaceuticals
Objective. To study the safety and efficacy of microtransesophageal echocardiography (micro-TEE) and TEE during percutaneous atrial septal defect (ASD) and patent foramen ovale (PFO) closure. Background. TEE has proven to be safe during ASD and PFO closure under general anaesthesia. Micro-TEE makes it possible to perform these procedures under local anaesthesia. We are the first to describe the safety and efficacy of micro-TEE for percutaneous closure. Methods. All consecutive patients who underwent ASD and PFO closure between 2013 and 2018 were included. The periprocedural complications were registered. Residual shunts were diagnosed using transthoracic contrast echocardiography (TTCE). All data were compared between the use of TEE or micro-TEE within the ASD and PFO groups separately. Results. In total, 82 patients underwent ASD closure, 46 patients (49.1 ± 15.0 years) with TEE and 36 patients (47.8 ± 12.1 years) using micro-TEE guidance. Median device diameter was, respectively, 26 mm (range 10–40 mm) and 27 mm (range 10–35 mm). PFO closure was performed in 120 patients, 55 patients (48.6 ± 9.2 years, median device diameter 25 mm, range 23–35 mm) with TEE and 65 patients (mean age 51.0 ± 11.8 years, median device diameter 27 mm, range 23–35 mm) using micro-TEE. There were no major periprocedural complications, especially no device embolizations within all groups. Six months after closure, there was no significant difference in left-to-right shunt after ASD closure and no significant difference in right-to-left shunt after PFO closure using TEE or micro-TEE. Conclusion. Micro-TEE guidance without general anaesthesia during percutaneous ASD and PFO closure is as safe as TEE, without a significant difference in the residual shunt rate after closure.
BackgroundIn Fontan patients with atrial arrhythmias (AA), non-vitamin K antagonist oral anticoagulants(NOACs) have a class III recommendation according to the Pediatric & Congenital Electrophysiology Society (PACES)/Heart Rhythm Society (HRS) guideline in 2014, due to lack of data on outcomes as opposed to evidence of harm. To address this gap in data, we investigated the safety and efficacy of NOACs in adults with a Fontan circulation in a worldwide study.MethodsThis is an international multicentre prospective cohort study, using data from the NOTE (non-vitamin K antagonistoral anticoagulants forthromboembolic prevention in patients with congenital heart disease) registry. The study population comprised consecutive adults with a Fontan circulation using NOACs. Follow-up took place at 6 months and yearly thereafter. The primary endpoints were thromboembolism and major bleeding. Secondary endpoint was minor bleeding.ResultsFrom April 2014 onward, 74 patients (mean age 32±10 years (range 18–68), 54% male) with a Fontan circulation using NOACs were included. During a median follow-up of 1.2 (IQR 0.8–2.0) years, three thromboembolic events (2.9 per 100 patient-years (95% CI 0.7 to 7.6)) and three major bleedings (2.9 per 100 patient-years (95% CI 0.7 to 7.6)) occurred in five atriopulmonary Fontan and one total cavopulmonary connection Fontan patients with AA. Fifteen patients experienced minor bleeding episodes (15.8 per 100 patient-years (95% CI 9.1 to 25.2)). In patients (n=37) using vitamin K antagonists (VKAs) prior to the initiation of NOAC, annual incidence of historical thromboembolic events and major bleeding were 2.4% (95% CI 0.4% to 7.4%) (n = 2) and 1.2% (95% CI 0.7% to 5.1%) (n = 1), respectively.ConclusionsIn this review of the largest Fontan cohort using NOACs with prospective follow-up, NOACs appear to be well tolerated and their efficacy and safety during short-term follow-up seem comparable to VKAs. Longer term data are required to confirm these promising short-term results.
ObjectiveTo evaluate the safety and efficacy of the Occlutech patent foramen ovale (PFO) device at long‐term follow‐up (FU).BackgroundThe Occlutech device has been proven safe and effective six‐months after percutaneous PFO closure. We describe the safety and efficacy after more than 1,300 patient‐years of FU.MethodsAll consecutive patients who underwent PFO closure between October 2008 and December 2015 were included. All complications were registered. Residual right‐to‐left shunt (RLS) was diagnosed using contrast transthoracic echocardiography and graded as minimal, moderate, or severe.ResultsIn total, 250 patients (mean age 53.5 ± 10.7 years, 46.8% female) underwent percutaneous PFO closure using the Occlutech device. Mean FU was 5.9 ± 1.8 years, a total of 1,345 patient‐years. Transient ischemic attack (TIA) or stroke was the main indication for closure (89.6%). Implantation was successful in 100%, no major complications occurred. Minor complications were inguinal hematoma in 16 patients (6.4%), pericardial effusion without the need for intervention in one patient (0.4%) and a supraventricular tachycardia in one patient (0.4%). A moderate or large shunt at one‐year follow up was present in 5.9%. A cerebrovascular vascular event occurred in 2.0% at 1‐year FU (four TIA, one stroke) and in 7.4% at long‐term FU (nine TIA, eight stroke). The total cerebrovascular event rate (TIA and CVA) was 0.02% per patient‐year of FU, with a stroke rate of 0.01%.ConclusionThe Occlutech device appears to be safe at long‐term FU with a very low annual cerebrovascular event rate and a low moderate to large shunt rate at 1‐year FU.
In patients with heart failure and preserved or mildly reduced ejection fractions (EF >= 40%), implantation of an interatrial shunt device (IASD) resulted in heterogenous changes of the left atrial (LA) volume. Baseline characteristics that correlate with a favorable decrease in LA volume are unknown. We hypothesized that a larger ratio of left to right atrial volume at baseline would correlate strongly with LA volume decongestion following IASD implantation. Reduce Elevated LA Pressure in Patients With Heart Failure was a multicenter study of the safety and feasibility of IASD implantation. Sixty-four patients with EF >= 40% underwent device implantation along with baseline conventional echocardiograms, speckle tracking echocardiography, and resting and exercise hemodynamics. Higher LA compliance (-4.2%, p = 0.048) and right atrial reservoir strain (-0.8%, p = 0.005) were independently associated with a percent decrease in the systolic LA volume index from baseline to 6-months. In conclusion, greater LA volume reduction following IASD implantation is associated with higher baseline compliance of the left atrium and higher reservoir strain of the right atrium. (C) 2019 Elsevier Inc. All rights reserved.