Percutaneous Closure Research Articles

A very rare and unusual complication after a percutaneous patent foramen ovale closure.

A very rare and unusual complication after a percutaneous patent foramen ovale closure.

Emergent percutaneous closure of sub-annular aortic root pseudoaneurysm in the setting of composite graft dehiscence: a case report

Abstract Background Aortic conduit pseudoaneurysms are rare complications of surgical aortic root replacements. These complications are typically treated with a redo-sternotomy, but these surgeries carry high mortality rates, and patients may not always be good surgical candidates. There have been a few reported cases where aortic pseudoaneurysms have been successfully treated percutaneously with both short- and long-term success. We describe a case were a sub-annular aortic root pseudoaneurysm was closed using an Amplatzer Vascular Plug 2 device. Case summary A 68-year-old man was admitted to the hospital 6 weeks after surgical aortic valve and aortic root replacement undergone for prosthetic valve endocarditis. On computed tomography, he was found to have a large fluid collection with extravasation into a false lumen located on the right side of the ascending aorta. Diagnostic catheterization confirmed flow into the pseudoaneurysm cavity from a sub-annular location. This defect was then closed using an Amplatzer Vascular Plug 2 device, with no residual flow or concern for re-opening at 8 months follow-up. Discussion This case presents the first documented use of an Amplatzer Vascular Plug 2 to close an aortic root pseudoaneurysm in the sub-annular location. Heart team discussion is crucial in determining whether surgical or percutaneous treatment management should be performed. This case highlights a novel treatment method for sub-annular aortic root pseudoaneurysms which can be considered an alternative to surgery and potentially life-saving for high-risk patients.

Clinical Effectiveness and Safety Comparison between Reduced Rivaroxaban Dose and Dual Antiplatelet Therapy for Nonvalvular Atrial Fibrillation Patients Following Percutaneous Left Atrial Appendage Closure: A Prospective Observational Study.

Device-related thrombosis (DRT) after successful closure implantation on left atrial appendage (LAA) was considered as a major challenge and optimal strategy on antithrombotic therapy remains to be solved. This study was performed to compare the clinical effectiveness and safety of reduced rivaroxaban dose (RRD) and dual antiplatelet therapy (DAPT) after left atrial appendage closure (LAAC) implantation with the Watchman device. After successful LAAC, consecutive participants were medicated with a standard DAPT or RRD. The primary endpoints included DRT, thrombosis events (TE), and bleeding events that were documented during a 12-month follow-up period. 767 patients (DAPT: n = 140; RRD: n = 627) were initially included. After propensity score matching (PSM), 140 patients treated with DAPT and 280 patients with RRD were included in each group with similar baseline information, thromboembolic and bleeding risk factors, cardiovascular risk factors and concomitant medication. In the RRD group, 193 patients were on rivaroxaban 15 mg ( ) and 47 received rivaroxaban 10 mg ( ). The incidence of DRT was documented in 12 (9.3%) patients in the DAPT group and 3 (6.3%) in and 7 (3.0%) in (log-rank p = 0.050). DAPT subgroups were more likely to experience shorter time to DRT as compared to ( vs. DAPT hazard ratio (HR) = 0.334, p = 0.015, 95% CI: 0.131-0.850). The median length of DRT in the group was significantly lower than that of the DAPT group (1.721 [1.610-1.818] mm vs. 1.820 [1.725-1.925] mm, p = 0.029). Compared with the unadjusted estimated rates of ischemic events for patients with similar congestive heart failure, hypertension, age 75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category ( - ) scores, a significant decrease of 68.6% in ischemic stroke rates was noted in the group, which contributed to a 54.9% reduction of overall thromboembolic events. The overall minor bleeding was not significantly different amongst the three groups (p = 0.944). Procedural bleeding was more common in the DAPT group, as compared with the and groups. After successful closure implantation, long-term RRD significantly reduced the DRT and TE occurrence compared with DAPT.

Impact of a Successful Percutaneous Mitral Paravalvular Leak Closure on Long-term Major Clinical Outcomes

BackgroundPercutaneous mitral paravalvular leak (PVL) closure techniques are an effective and safe alternative to surgical treatment, but data regarding long-term outcomes are scarce. We aim to describe the impact of successful percutaneous mitral PVL closure on long-term outcomes. MethodsAll consecutive patients in whom a first-attempt percutaneous mitral PVL closure was performed in a single tertiary centre between January 2010 and October 2021 were included. Clinical variables, procedural details, and procedural success were collected. Patients were classified based on procedural success, defined as no more than mild residual leak. All-cause mortality was the primary endpoint. Cardiovascular death and heart failure hospitalizations (HFHs) were key secondary endpoints. ResultsNinety patients (median age 72.5 years [66.0-78.4]; median EuroSCORE-II 8.2 [5.3-12.46]) were included. Although reduction of at least 1 degree in PVL severity was achieved in 82 (91.1%), procedural success was achieved in 47 (52.2%). Chronic kidney disease, previous surgery for PVL, and the presence of multiple jets were independently associated with procedural failure. After a median follow-up of 3.2 (1.2-5.2) years, mortality rate was higher in the procedural failure group (27.3 per 100 patients-years) compared with the group with successful closure (8.2 per 100 patient-years). Procedural failure was associated with all-cause death (adjusted hazard ratio [aHR], 2.59; 95% confidence interval [CI], 1.41-4.78), cardiovascular death (aHR, 3.53; 95% CI, 1.67-7.49) and HFH (aHR, 3.27; 95% CI,1.72-6.20). ConclusionsA successful reduction in PVL to mild or absent is associated with improved rates of all-cause death, cardiovascular death, and HFHs.

A Retrospective Cohort Evaluation of Left Ventricular Remodeling, Perioperative Complications and Outcome in Medium and Large Size Dogs with Patent Ductus Arteriosus after Percutaneous Closure.

This retrospective cohort study included one hundred fifty-seven medium and large-size dogs with the aim of evaluating the effect of signalment and echocardiographic features on complications, outcomes and left ventricular modifications before and after patent ductus arteriosus (PDA) closure. The patients were divided in two groups based on the heart remodeling after closure: Group A included dogs that had a reduction in the end-systolic volume index (ESVI) after closure compared to the ESVI measured before; Group B included dogs without a reduction in ESVI after closure. Body weight, minimal ductal diameter (MDD) of PDA, end-diastolic volume index and presence of arrhythmias at presentation were significantly higher in Group B compared to Group A. The shortening fraction and ejection fraction after closure were reduced in both groups, but in Group B there was a major reduction, and the mean values indicated a possible systolic dysfunction. Complications during the procedure and death due to cardiac reasons were greater in Group B compared to Group A. In conclusion, a higher body weight, a larger MDD, a more severe heart enlargement or arrhythmias at presentation increased the risk of developing a worsening structural and functional condition after ductal closure, and this can be associated with perioperative complications and cardiac death.

Antithrombotic Regimen After Percutaneous Left Atrial Appendage Closure - A Real-World Study.

Antithrombotic therapy after left atrial appendage closure (LAAC) in patients at high risk of bleeding remains controversial. We present real-world clinical outcomes of LAAC.Methods and Results: Data from 74 consecutive patients who received LAAC therapy between January 2020 and June 2022 were analyzed. Patients received 1 of 3 antithrombotic therapies according to the bleeding risk category or clinical event. Regimen 1 was based on a prior study, regimen 2 comprised a lower antiplatelet drug dose without dual antiplatelet therapy, and regimen 3 was antiplatelet drug administration for as long as possible to patients with uncontrollable bleeding who were required to stop anticoagulant drugs. Overall, 73 (98.6%) procedures were successful. Of them, 16 (21.9%) patients were selected for regimen 1, 46 (63.0%) for regimen 2, and 11 (15.1%) for regimen 3. Device-related thrombosis (13% vs. 0% vs. 0%, P=0.0257) only occurred with regimen 1. There was no difference in major bleeding event rates (6% vs. 2% vs. 9%, P=0.53). The post-LAAC antithrombotic regimen was modified without major concerns.

A case report of percutaneous closure of left ventricular pseudoaneurysm

A case report of percutaneous closure of left ventricular pseudoaneurysm

Rationale and design of a randomized clinical trial evaluating the efficacy of mechanical neuroprotection in reducing the risk of silent brain infarcts associated with percutaneous left atrial appendage closure: study protocol for a LAAC-SBI trial

BackgroundLeft atrial appendage closure (LAAC) procedures prevent cardioembolic stroke in patients with atrial fibrillation who have contraindications to oral anticoagulant medications. However, these procedures carry certain risks of peri-procedural complications. One such complication is silent brain infarcts (SBI), which can lead to cognitive impairment and mood disturbances. The implementation of mechanical neuroprotection systems during LAAC procedures may reduce the risk of SBI and associated cognitive and mood disorders.MethodsThe LAAC-SBI trial is a prospective, multicenter, randomized, and double-blind interventional study. The study aims to enroll a total of 240 patients, with 120 patients allocated to each group. The study group will evaluate the use of the Sentinel CPS during LAAC, while the control group will undergo LAAC procedures without the Sentinel CPS. The primary endpoint of the study is the number of new SBIs or stroke foci detected by diffusion-weighted magnetic resonance imaging (DW MRI). Secondary endpoints include deterioration of cognitive function, development of dementia syndrome, and occurrence of depressive disorders. These endpoints will be assessed using questionnaire tools such as the Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT), Controlled Oral Word Association Test (COWAT), and Hospital Anxiety and Depression Scale (HADS). The observational period for patients in the study is 2 years.DiscussionIf the study demonstrates a favorable outcome with reduced incidence of SBI and improved cognitive and mood outcomes in patients receiving cerebral protection devices during LAAC, it will have significant implications for clinical management standards. This would support the use of neuroprotection devices not only for LAAC but also in procedures such as atrial fibrillation ablation or transcatheter mitral valve interventions, where the risk of embolic events and subsequent brain injury may also be present.Trial registrationClinicalTrials.gov NCT05369195. Registration on 11.05.2022.

Morphometrical features of left atrial appendage in the atrial fibrillation patients subjected to left atrial appendage closure.

This study aimed to evaluate the morphometrical features of left atrial appendage (LAA) in patients with atrial fibrillation, subjected to LAA percutaneous closure (LARIAT) for stroke prevention. Computed tomography (CT) scans of 51 patients with atrial fibrillation subjected to LARIAT procedure were comparatively evaluated with 50 patients with sinus rhythm (control group). Three-dimensional reconstructions were created using volume-rendering for evaluation. No differences were found in LAA types of distribution (cauliflower: 25.5 vs. 34.0%, chicken wing: 45.1 vs. 46.0%, arrowhead: 29.4 vs. 20.0%, all p > 0.05) between groups. However, the study group was characterized by LAAs with a lower number of lobes. The LAA orifice anteroposterior and transverse diameters (19.3 ± 4.12 vs. 17.2 ± 4.0 mm, p = 0.01 and 25.1 ± 5.1 vs. 20.5 ± ± 4.4 mm, p = 0.001), orifice area (387.2 ± 133.9 vs. 327.1 ± 128.3 mm2, p = 0.02) and orifice perimeter (70.2 ± 12.5 vs. 61.2 ± 11.6 mm, p = 0.04) was significantly larger in atrial fibrillation patients. More oval LAA orifices was found in atrial fibrillation group (94.0 vs. 70.4%, p = 0.001). No statistically significant differences were found in LAA body length (47.4 ± 15.4 vs. 43.7 ± 10.9 mm, p = 0.17), body width (24.7 ± 5.6 vs. 24.4 ± 5.8 mm, p = 0.81), and chamber depth (17.7 ± 3.5 vs. 16.5 ± 3.8 mm, p = 0.11). Calculated LAA ejection fraction was significantly lower in study group compared to healthy patients (16.4 ± 14.9 vs. 48.2 ± 12.9%, p = 0.001). Important morphometrical differences in LAA orifice have been found, which was significantly larger and more oval in patients with atrial fibrillation compared to healthy controls. Although no difference in LAA body type and size was observed; the LAA ejection fraction was significantly lower in atrial fibrillation rhythm patients.

Heart-Stroke Team: A multidisciplinary assessment of patent foramen ovale-associated stroke.

Patent foramen ovale (PFO) closure prevents recurrent ischemic stroke in selected patients with a cryptogenic stroke. Trial results tend to be generalized to daily practice, often extending original trial inclusion criteria. This may result in unnecessary closure without benefit, but with risk of complications. We therefore introduced a standardized and structured evaluation by an interdisciplinary Heart-Stroke Team (HST). Our aim was to investigate the proportion of actual PFO closure of all referred patients with a cryptogenic stroke, after evaluation by the HST. We conducted a single-center, retrospective cohort study. Patients with an assumed cryptogenic ischemic stroke or transient ischemic attack (TIA) and a PFO who were referred for PFO closure were analyzed. As part of the HST approach, all patients underwent a standardized work-up, first to demonstrate the ischemic event on neuroimaging, second to evaluate all potential causes of stroke and finally, to assess the possible relation between the PFO and stroke. Outcome was the proportion of patients treated with PFO closure after referral. A total of 195 patients were included. In 124 patients (64%) PFO closure was advised. Fourty-two (22%) patients had a clear alternative cause of stroke and in 13 (7%) patients the initial stroke diagnosis could not be confirmed. After careful analysis of patients referred for PFO closure a relationship between the PFO and stroke could not be demonstrated in 32% of referrals, and 3% preferred best medical treatment over percutaneous closure. This stresses the need for a complete neurovascular work-up and multidisciplinary assessment.

Predictors of tricuspid regurgitation and right ventricular remodelling following percutaneous atrial septal defect closure

Abstract Background Atrial septal defects (ASD) are one of the most common congenital heart defects, and if left unrepaired, life expectancy is decreased due to pulmonary hypertension (pHTN), atrial arrhythmias, and heart failure. Residual right ventricular (RV) dilation or dysfunction despite ASD closure can lead to worse outcomes. Purpose There is insufficient data on predictors of poor RV remodelling following ASD closure in adults. In this study, we aimed to identify risk factors of persistent RV dilation or dysfunction despite percutaneous ASD closure. Methods Patients undergoing primary percutaneous ASD closure between 1/2010-6/2021 were followed for a year. Patients with hemodynamically insignificant or iatrogenic ASDs, pHTN and Eisenmenger syndrome were excluded. Non-linear multiphase mixed–effects cumulative logistics regression model was used to assess the trend of the individual’s degree of TR, RV dysfunction and size over time. This was further stratified by age group (≥40 and <40). Partial dependence plot was used to study the association between age, body surface area (BSA), degree of RV and left ventricle (LV) dysfunction pre-procedurally with the likelihood of lack of RV remodelling. The association between ASD size and the likelihood of sustained RV dysfunction following ASD closure was also studied. Results A total of 185 patients met the inclusion criteria. The median age was 41 and 63% were female. The mean follow-up time of 3.6 months (range 1 day to 4.5 years). 249 echocardiograms were retrieved. Results showed a transient worsening of TR in the first 3 months post-ASD closure, which was more pronounced in older patients (≥40) (Figure 1). A larger ASD size was associated with a higher likelihood of early moderate or greater RV dysfunction (Figure 2). All patients had some degree of RV remodelling following the procedure. Older patients (≥40) were more likely to have RV dysfunction at the time of closure. Older age, RV and LV dysfunction, and high BSA were associated with poor RV remodelling or persistent RV dilation a year after ASD closure (Figure 3). Conclusions Patients who underwent percutaneous ASD closure with at least one of the following risk factors: age greater than 40, larger ASD, ventricular dysfunction, and high BSA require closer long-term follow-up given the reduced RV remodelling. Future studies are needed to elucidate the effect of poor RV remodelling on functional capacity, arrhythmic burden, and progression of TR and long-term outcomes.

Long- term results of interventional treatment of paravalvular leaks after prosthetic valve replacement with plug devices. Results from a prospective registry

Abstract Background Interventional closure of paravalvular leaks (PVL) after surgical valve replacement has developed to an attractive treatment option for patients at high operative risk. There is a lack of prospective data on long- term clinical outcome after percutaneous PVL closure. Methods We analysed data from a multicenter prospective registry on interventional PVL closure. Results 41 patients (10 women and 31 men) with symptomatic PVL were included in the plug registry at nine German hospitals from 2014 until 2020. In total 67 plug implantations were accomplished, 46.3% of procedures were performed for aortic PVLs and 53.7% were done for mitral PVLs. In 82% of patients PVL closure was performed once, in 16% of patients twice and 2,0% underwent three procedures. Mean age was 68.,7 ± 13.5 years. Indication was symptomatic heart failure with NYHA class ≥ II (63.4%), hemolysis (4.9%) or NYHA class ≥ II and hemolysis (31.7%). Mean log. Euro-Score I was 16.6 ± 11.6%. Aortic PVLs were treated using a retrograde transfemoral access (100%), mitral PVLs were treated using either a transseptal (96%) or transapical access (4%). For the first performed PVL closure the median procedural time was 100 minutes, fluoroscopy time was 31 minutes. Interventional closure of PVL was completely successful in 76%, partially successful in 10% and failed in 14%. Clinical improvement of at least one NYHA class was achieved in 56.4% and of two NYHA classes in 15.4% of patients after the procedure. In 7.3% hemolysis and transfusion dependence were successfully treated by plug implantation. Postprocedurally a severe aortic PVL was described in 4.2% (preprocedural in 41.7%) and a severe mitral PVL was seen in 8.3% (preprocedural in 47.6%). Interventional complications occurred in 21.9%. In-hospital mortality rate was 4.9%. A follow-up was performed after 30 days, 12 months, 3 and 5 years. Within a median time of 511 days (quartiles: 45;1136 days) 10 patients died. Mortality rates were 10.1% at one-year-, 18.5% at 3-year- and 32.5% at 5-year-follow-up. After one-year follow-up two reinterventions on the aortic valve (7.7%) were needed (one for PVL and one for treatment of an aortic stenosis), whereas two reinterventions (7.7%) were performed for mitral PVLs (1 percutaneous and 1 surgical PVL-closure). After 3-year follow-up one further percutaneous PVL closure (3.2%) was performed for an aortic and two further PVL closures (6.5%) for mitral PVLs (1 percutaneous, 1 surgical). After 5-year follow-up no PVL closure was necessary. The estimated rates for mortality and/or reintervention (either surgical or interventional) were 25.6% at one-year, 36.8% at 3 years and 45.1% at 5-year follow-up. Conclusion The multicenter plug-registry describes a high procedural success rate with clinical improvement in the majority of patients and acceptable long-term outcomes after percutaneous PVL closure.

Reporting quality of randomized controlled trials of percutaneous patent foramen ovale closure for the treatment of migraine based on the CONSORT statement

Abstract Background Although several retrospective and non-randomized studies support reduction of migraine frequency and severity after patent foramen ovale (PFO) closure, three randomized controlled trials (RCTs) in this setting have not met their primary efficacy endpoints. In addition, currently there are is no analysis of the quality of RCTs of percutaneous PFO closure for the treatment of migraine. Purpose The present study aims to determine the reporting quality of RCTs focusing on the PFO closure for the treatment of migraine according to the revised CONsolidated Standards Of Reporting Trials (CONSORT) 2010 checklist. Methods Systematic searches of 2 databases (MEDLINE/PubMed and Cochrane library) were conducted. The search strategy identified reports on RCTs involving patients with migraine and PFO who were randomized to transcatheter device closure of PFO or medical treatment in order to investigate the effect of PFO closure for migraine. The primary objective was to establish the mean CONSORT compliance of RCTs of PFO closure for the treatment of migraine and secondary objectives were the calculation of compliance per CONSORT item and effect of CONSORT statement in high-ranked medical journals. Quality of reporting was assessed using a 37-item questionnaire based on the revised CONSORT 2010 checklist. Reporting above 75% of the items was defined as adequate compliance to the CONSORT statement. Results The search identified 3 eligible articles for analysis. The mean compliance was 69.66% ± 4.49%. Among the studies, only 1 RCT (PRIMA Trial) registered a good reporting quality (75% of the CONSORT items), whereas there were no RCTs with a CONSORT compliance less than 50% (Figure 1). Among assessed items, 19 items (51.4%) were reported in all (100%) of the articles. Also, 26 of the 37 items of the checklist (70.3%) were reported in more than half of the studies. The majority of the Results items registered an adequate reporting whereas randomization items were not so sufficiently reported overall (Figure 2). Each one of the RCTs used in the analysis were published in high-ranked medical journals (IF>30). However, none of the studies reported all 37 items achieving 100% CONSORT compliance score. Conclusions Based on the present results, quality of reporting in RCTs focusing on the PFO closure for the treatment of migraine remains suboptimal according to the CONSORT analysis. In this sense, better designed RCTs on the management of migraine by PFO closure are currently needed to guide future clinical practice.Figure 1.Figure 2.

Impact of the antiplatelet strategy following patent foramen ovale percutaneous closure

Abstract Background Temporary dual antiplatelet therapy (DAPT) is recommended following patent foramen ovale (PFO) percutaneous closure although its benefit, compared to single antiplatelet therapy (SAPT), has not been demonstrated in this setting. Objective We aimed at assessing outcomes following PFO closure according to the antiplatelet strategy at discharge. Methods The ambispective AIR-FORCE cohort included consecutive patients from 7 centers in France and Canada undergoing PFO closure and discharged without anticoagulation. Patients treated in French and Canadian centers were mostly discharged with DAPT and SAPT, respectively. The primary endpoint was the composite of death, stroke, transient ischemic attack, peripheral embolism, myocardial infarction, or BARC type ≥2 bleeding with up to 5 years of follow-up. The impact of the antiplatelet strategy on outcomes was evaluated with a marginal Cox model (cluster analyses per country) with inverse probability weighting according to propensity score. Results A total of 1,532 patients were included from 2001 to 2022, of whom 599 (39.1%) were discharged with SAPT and 933 (60.9%) with DAPT, for ≤3 months in 894/923 (96.9%) cases (Table 1). After a median follow-up of 2.4[1.1-4.4] years, a total of 58 events were observed. In the weighted analysis the rate of the primary endpoint up to 5 years was 7.8% in the SAPT strategy and 7.3% in the DAPT strategy (weighted hazard ratio 1.04, 95% confidence interval 0.59-1.83) (Figure 1). Results were consistent in a sensitivity analysis. Conclusion The strategy of antiplatelet strategy following PFO closure did not seem to impact clinical outcomes, thus challenging the current recommendations of temporary DAPT.Table 1.Baseline characteristicsFigure 1.Central illustration

Embolization of percutaneous left atrial appendage closure devices: timing, management and associated clinical outcomes

Abstract Background Percutaneous left atrial appendage occlusion (LAAO) is a good option to mitigate stroke risk in patients with atrial fibrillation. Device embolization is infrequent but a serious complication. Objectives We aim to describe timing, management and clinical outcomes of device embolization in an international multi-center registry. Methods Patient characteristics, imaging findings, procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. Results Sixty-seven centers contributed data on 125 patients who underwent LAAO and experienced device embolization at an embolization rate between 0 and 3.9 % per 100 person-years. Device embolization within the first 24 hours post-procedural occurred in 69.4% of cases. The device was left in place in three (2.8%) patients, a percutaneous retrieval was attempted in 83 (76.1%) and surgery was preferred in 23 (21.1%) patients. In 27/83 (32.5%) patients with an initial percutaneous retrieval attempt a second, additional procedure was performed, which was associated with a high mortality (death first attempt: 2.7% vs. second attempt: 18.5%, p<0.001[HS1] ). The primary outcome (bailout surgery, cardiogenic shock, and/or death) occurred in 43 (38.7%) patients. Major complications related to LAAO device embolization occurred in 39 (35.1%) patients. Conclusions The majority of device embolizations after LAAO occurs early. The percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was not successful.

The predictive value of compression rate on residual leak after left atrial appendage occlusion with watchman FLX

Abstract Background Incomplete left atrial appendage (LAA) occlusion due to residual leaks may occur after percutaneous closure procedure with Watchman FLX. Before release of device PASS (position, anchor, size and seal) criteria must be verified. Optimal compression rate for watchman FLX device is between 10-30% according to company recommendations. Purpose The aim of this study is to evaluate the correlation between compression rate and leak presence after left atrial appendage closure. Methods This is an observational retrospective study including patients that underwent LAA closure under transesophageal echocardiography (TEE) with at least one follow-up where complete LAA closure was assessed by TEE in our center between January 2021 and August 2022. TEE images were reviewed by the first author. Compression rate was calculated based on intraprocedural TEE images using the following formula: (original device size—size after deployment)/original device size*100. Patients were divided into 2 groups based on the compression rate: group 1: 10-30%; group 2: >30%. The rate of leak between groups was compared using the Chi-square test. Results 203 patients (mean age 79± 8 years) were included in the study. The implanted device size was 20 mm in 7 (3.4%), 24 mm in 30 (14.8%), 27 mm in 49 (24.1%), 31 mm in 75 (36.9%) and 35 mm in 42 (20.7%) patients. Based on the compression rate, patients were classified into group 1: >30% [n=37 (18.2%)] and group 2: ≤30% [n=166 (81.8%)]. Mean compression rate was 38.5% and 21.3% in group 1 and 2 respectively. At follow-up TEE, 1 (2.7%) patient in group 1 and 32 (19.3%) patients in group 2 were found to have a residual leak of >1 mm. When comparing leaks between the two groups, there was 1 leak in group 1 whereas in group 2 there were 32 leaks (1/37 vs 32/166, p value 0.01, RR 0.14, 95% CI, 0.02-0.74). Conclusion Devices with compression rate ≤30% were associated with significantly higher risk of residual leak.

Adult patients with univentricular physiology after Fontan palliation: prevalence and percutaneous closure of veno-venous collaterals

Abstract Background The Fontan operation resulted in improved survival of patients with congenital heart defects not equipped to sustain a biventricular circulation. Long-term complications are common. Veno-venous collaterals (VVC) can have both potentially beneficial and adverse physiological effects. The aim of this study was to evaluate the prevalence of VVC in adult Fontan patients and describe the percutaneous treatment strategy and the short term follow-up. Methods In this single-centre retrospective observational cohort study, consecutive adult Fontan patients under follow-up in the period between 2017-2023 were included. Results From a cohort of 51 Fontan patients, 14 (28%) underwent a percutaneous closure of VVC (71% female, mean age at intervention 24±4 years). Mean follow-up duration was 2.2±1.1 years. Indications were symptoms and/or significant exercise-related hypoxia. Ten patients (71%) had a systemic left ventricle, and 79% had an extracardiac tunnel (median conduit size 16[16-20]mm). Mean Fontan pressure was 10±4mmHg. Seven patients (50%) had Fontan-associated liver disease. A total of 24 VVC were occluded using coils and/or vascular plugs. No periprocedural complications occurred. The VVC originated from right-sided tributaries of the vena cava inferior (36%), superior vena cava (28%) or both (36%), with the majority draining directly into the pulmonary venous circulation. Eight patients (57%) reported a reduction of symptoms. Mean saturation in rest improved significantly, yet saturation during maximal exercise remained unchanged (94±3 to 97±3%, p=0.002 and 88±3 to 91±4%, p=0.103, respectively). Conclusions VVC are highly prevalent in the adult Fontan population and typically connect the right-sided tributaries of the vena cava inferior and/or superior with the pulmonary veins. Low Fontan pressures do not exclude the presence of VVC. Percutaneous closure of VVC is technically feasible and safe and is associated with reduction of symptoms and a significant rise in resting peripheral oxygen saturation. These results warrant further studies.

Microtransesophageal echocardiographic guidance of patent foramen ovale percutaneous closure

Abstract Introduction The important growth in the number of percutaneous patent foramen ovale (PFO) closure procedures requires to find alternatives to conventional guidance by transesophageal echocardiography (TEE) with general anesthesia (GA). The micro-TEE monitoring, with local anesthesia, could allow a reliable guidance with a reduced procedural length, without the need for GA. The objective of this study is to evaluate the effectiveness and safety of PFO closure guided by micro-TEE compared to conventional TEE under GA. Methods This retrospective single-center observational study included all consecutive patients admitted to our hospital, from January 2019 to June 2021 for PFO closure. The type of guidance was based on PFO’s morphological characteristics and patient’s choice. The primary endpoint was the successful implantation of at least one prosthesis without significant residual shunting (≤ grade 1). Key secondary endpoints were the procedure duration and periprocedural complications. Results A total of 237 patients (44% of female, mean age: 50 ± 14 years) were included, with TEE and micro-TEE guidance in 174 (73%) and 63 (27%) cases, respectively. Smaller devices were more frequently implanted among patients with micro-TEE compared to TEE guidance, with 59% vs. 44% respectively (p=0.04), reflecting cases selection on the basis of prior TEE. Overall, there was no case of procedural failure and the primary endpoint was obtained in 158 (91%) and 60 (95%) patients with TEE and micro-TEE guidance, respectively (p=0.27). Procedural duration was shorter with micro-TEE guidance (median time 8 (7-11)min versus 21 (16-27)min, p=0.01). The rate of peri-procedural complications was low (1.3% overall) and limited to periprocedural atrial arrhythmia, without significant differences in both groups (p>0.99). Conclusions Micro-TEE guidance may result in safe and shorter PFO percutaneous closure compared to TEE guidance with GA.These results obtained on selected patients must be confirmed on larger cohorts.

Percutaneous VSD closure with the KONAR-MF occluder: fusion helps

Percutaneous VSD closure with the KONAR-MF occluder: fusion helps

Abstract 13650: Trends in Women Cardiac Operators of Structural and Interventional Procedures in the United States

Background: Women have historically been underrepresented in cardiology workforces. Throughout the United States, there is a major underrepresentation of women in cardiology as operators within structural proceduralists and interventional cardiology (IC). Methods: We extracted data from the Medicare Provider Utilization and Payment Database (MPUPD) from 2013 to 2020. The MPUPD is an administrative database of services rendered to Medicare patients enrolled in a fee-for-service program. We sought operators who performed >10 procedures using procedure codes for percutaneous transcatheter closure of congenital atrial septal defect (ASD) with implant and percutaneous coronary intervention, transcatheter mitral valve replacement via transcutaneous edge to edge repairs (TEER), and percutaneous left atrial appendage closure (PLAAO) using relevant CPT codes. The proportion of women operators was analyzed across the 8-year period. Results: Between 2013 and 2020, women on average represented 3.02% of the 1,260 cardiac operators identified. Despite the number of total structural operators performing 10 or more procedures increasing from 9 to 871 over the 8-year period, the proportion of women remained unchanged at less than 4.5% (P = 0.712) (Figure 1). By procedure, the total ASD, TEER, and PLAAO operators have increased, though the proportion of women operators remained constant over time (P = .913, .725 and .891). Over the studied period, there were no women operators identified with over 10 operations in 28 states (56%) for any structural procedures, 49 states (98%) for ASD procedures, 39 states (78%) for TEER, and 33 states (66%) of PLAAO. Conclusion: Women continue to represent an overwhelming minority of structural cardiac operators. Despite a rapid rise in the total number of operators, the proportion of female operators has not increased. Prospective studies are needed to investigate the underlying factors contributing to these sex-related differences.