PICS/AEPC/APPCS/CSANZ/SCAI/SOLACI: Expert Consensus Statement on Cardiac Catheterization for Pediatric Patients and Adults With Congenital Heart Disease.

[Methodological Study of Reliability Test of Percutaneous Ventricular Assist Device].

Prior to clinical application, reliability of percutaneous ventricular assist devices(pVAD) requires to be tested systematically. Currently, there's a lack of dedicated reliability testing equipment and methodologies for pVAD. Considering the structural and functional aspects of percutaneous ventricular assist devices, this study conducts research on pVAD reliability test engineering. Test setups, clinical conditions, failure modes, effects analysis, and evaluation models have been investigated. A highly feasible methodological approach for percutaneous ventricular assist device reliability assessment has been formed. This study offers valuable insights into standardizing their reliability evaluation in clinical settings.

Study design and rationale of COMPETE: Comparison of the effect of medication therapy in alleviating migraine with patent foramen ovale.

BACKGROUND:Previous studies have examined the impact of antithrombotic agents on Patent Foramen Ovale (PFO) in relation to migraine. However, differences in effectiveness of different antithrombotic agents and traditional migraine medications are not known.METHODS/DESIGN:This study is an investigator-initiated, randomized, multicenter, single-masked (outcomes assessor), and active-controlled parallel-group trial (ClinicalTrials.gov Identifier: NCT05546320), with the objective of evaluating the prevention efficacy of antithrombotic agents compared to first-line migraine medication in PFO patients. The trial involves 1,000 migraine patients with a right-to-left shunt at the atrial level, randomized in a 1:1:1:1 fashion to receive either aspirin 300 mg QD, clopidogrel 75 mg QD, rivaroxaban 20 mg QD, or the active-control metoprolol 25 mg BID. The primary efficacy end point is the response rate, defined as a 50% or greater reduction in the average migraine attack days per month or in the average number of migraine attacks per month at 12-week visit compared to baseline.CONCLUSIONS:The COMPETE trial aims to provide valuable insights into the comparative effectiveness of antithrombotic agents and standard migraine therapies in patients with PFO. This study holds the promise of advancing treatment approaches for individuals having migraines associated with PFO, thus addressing an important gap in current migraine management strategies.

Hemodynamics, anatomy, and outcomes of quadricuspid aortic valves: Multimodality imaging assessment.

BACKGROUND:Quadricuspid aortic valve (QAV) is a rare congenital heart disease with a limited body of literature. This retrospective cohort study investigates QAV morphology, function, and clinical outcomes.METHODS:Echocardiography was used to assess valvular function. Morphological characteristics such as phenotypes, raphe, regurgitant orifice area (ROA), and aortic dilation (diameter >40 ​mm) were assessed by cardiac CT. Patients were followed up for the combined event of all-cause death and aortic valve replacement (AVR).RESULTS:Ninety QAV patients (screened from 322385 CT scans) were included (mean age 55.2 ​± ​13.6 years, 61.1 ​% male). Isolated significant aortic regurgitation (AR) was present in 75.6 ​% of patients. The cohort was dominated by type I (four equal leaflets, 37.8 ​%) and type II (3 larger and 1 smaller leaflets, 42.2 ​%) QAV. Fused raphe was present in 26.7 ​% of patients. ROACT was correlated with AR severity and aortic dilation (41.1 ​%, n ​= ​37). Among patients without AVR at baseline (n ​= ​60), one died and 17 underwent AVR during a median follow-up of 35.0 months (IQR:17.3-62.8). ROACT was associated with an increasing risk of combined event (as a categorical variable with a cut-off of 21.4 ​mm2, HR ​= ​4.25, 95%CI 1.49-12.17, p ​= ​0.007; as a continuous variable (per mm2 increment), HR ​= ​1.04, 95%CI 1.01-1.07, p ​= ​0.003). Additionally, ROACT had incremental prognostic value when added to the AR severity model (area under the receiver-operating characteristic curve increased from 86.8 to 88.4, p ​= ​0.004).CONCLUSION:QAV is characterized by variable anatomy, progressive AR, concomitant cusp fusion and aortic enlargement. ROACT may be a potential ancillary prognostic marker in patients with QAV.

Corrigendum to 'Alerting trends in epidemiology for non-rheumatic degenerative mitral valve disease, 1990-2019: An age-period-cohort analysis for the Global Burden of Disease Study 2019' [Int. J. Cardiol. 395(2024) 131561].

Alerting trends in epidemiology for non-rheumatic degenerative mitral valve disease, 1990-2019: An age-period-cohort analysis for the Global Burden of Disease Study 2019.

BACKGROUND:The global and national burden of rheumatic mitral valve disease (MVD) has been well studied and estimated before. However, little is known about non-rheumatic degenerative MVD. Therefore, this study aimed to assess the trends in non-rheumatic degenerative MVD (NRDMVD) epidemiology, with an emphasis on NRDMVD mortality, leading risk factors, and their associations with age, period, and birth cohort.METHODS:Using the data derived from the Global Burden of Disease Study 2019, including prevalence, mortality, and disability-adjusted life years, we analyzed the burden of NRDMVD and the detailed trends of NRDMVD mortality over the past 30 years in 204 countries and territories by implementing the age-period-cohort framework.RESULTS:Globally, the number of deaths due to NRDMVD increased from 5695.89 (95% uncertainty interval [UI]: 5405.19 to 5895.4) × 1000 in 1990 to 9137.79 (95% UI: 8395.68 to 9743.55) × 1000 in 2019. The all-age mortality rate increased from 106.47 (95% UI: 101.03 to 110.2) per 100,000 to 118.1 (95% UI: 108.51 to 125.93) per 100,000, whereas the age-standardized mortality rate decreased from 170.45 (95% UI: 159.61 to 176.94) per 100,000 to 117.95 (95% UI: 107.83 to 125.92) per 100,000. The estimated net drift of mortality per year was -1.1% (95% confidence interval: -1.17 to -1.04). The risk of death due to NRDMVD increased with age, reaching its peak after 85 years old globally. Despite female patients being associated with lower local drift than male patients, no significant gender differences were observed in the age effect across countries and regions for all sociodemographic index (SDI) levels, except low-SDI regions.CONCLUSIONS:We estimated the global disease prevalence of and mortality due to NRDMVD over approximately a 30-year period. The health-related burden of NRDMVD has declined worldwide; however, the condition persisted in low-SDI regions. Moreover, higher attention should be paid to female patients.

Biodegradable Cardiac Occluder with Surface Modification by Gelatin-Peptide Conjugate to Promote Endogenous Tissue Regeneration.

Transcatheter intervention has been the preferred treatment for congenital structural heart diseases by implanting occluders into the heart defect site through minimally invasive access. Biodegradable polymers provide a promising alternative for cardiovascular implants by conferring therapeutic function and eliminating long-term complications, but inducing in situ cardiac tissue regeneration remains a substantial clinical challenge. PGAG (polydioxanone/poly (l-lactic acid)-gelatin-A5G81) occluders are prepared by covalently conjugating biomolecules composed of gelatin and layer adhesive protein-derived peptides (A5G81) to the surface of polydioxanone and poly (l-lactic acid) fibers. The polymer microfiber-biomacromolecule-peptide frame with biophysical and biochemical cues could orchestrate the biomaterial-host cell interactions, by recruiting endogenous endothelial cells, promoting their adhesion and proliferation, and polarizing immune cells into anti-inflammatory phenotypes and augmenting the release of reparative cytokines. In a porcine atrial septal defect (ASD) model, PGAG occluders promote in situ tissue regeneration by accelerating surface endothelialization and regulating immune response, which mitigate inflammation and fibrosis formation, and facilitate the fusion of occluder with surrounding heart tissue. Collectively, this work highlights the modulation of cell-biomaterial interactions for tissue regeneration in cardiac defect models, ensuring endothelialization and extracellular matrix remodeling on polymeric scaffolds. Bioinspired cell-material interface offers a highly efficient and generalized approach for constructing bioactive coatings on medical devices.

A generalized deep learning model for heart failure diagnosis using dynamic and static ultrasound.

Objective:Echocardiography (ECG) is the most common method used to diagnose heart failure (HF). However, its accuracy relies on the experience of the operator. Additionally, the video format of the data makes it challenging for patients to bring them to referrals and reexaminations. Therefore, this study used a deep learning approach to assist physicians in assessing cardiac function to promote the standardization of echocardiographic findings and compatibility of dynamic and static ultrasound data.Methods:A deep spatio-temporal convolutional model r2plus1d-Pan (trained on dynamic data and applied to static data) was improved and trained using the idea of "regression training combined with classification application," which can be generalized to dynamic ECG and static cardiac ultrasound views to identify HF with a reduced ejection fraction (EF < 40%). Additionally, three independent datasets containing 8976 cardiac ultrasound views and 10085 cardiac ultrasound videos were established. Subsequently, a multinational, multi-center dataset of EF was labeled. Furthermore, model training and independent validation were performed. Finally, 15 registered ultrasonographers and cardiologists with different working years in three regional hospitals specialized in cardiovascular disease were recruited to compare the results.Results:The proposed deep spatio-temporal convolutional model achieved an area under the receiveroperating characteristic curve (AUC) value of 0.95 (95% confidence interval [CI]: 0.947 to 0.953) on the training set of dynamic ultrasound data and an AUC of 1 (95% CI, 1 to 1) on the independent validation set. Subsequently, the model was applied to the static cardiac ultrasound view (validation set) with simultaneous input of 1, 2, 4, and 8 images of the same heart, with classification accuracies of 85%, 81%, 93%, and 92%, respectively. On the static data, the classification accuracy of the artificial intelligence (AI) model was comparable with the best performance of ultrasonographers and cardiologists with more than 3 working years (P = 0.344), but significantly better than the median level (P = 0.0000008).Conclusion:A new deep spatio-temporal convolution model was constructed to identify patients with HF with reduced EF accurately (< 40%) using dynamic and static cardiac ultrasound images. The model outperformed the diagnostic performance of most senior specialists. This may be the first HF-related AI diagnostic model compatible with multi-dimensional cardiac ultrasound data, and may thereby contribute to the improvement of HF diagnosis. Additionally, the model enables patients to carry "on-the-go" static ultrasound reports for referral and reexamination, thus saving healthcare resources.

Transcatheter closure of perimembranous ventricular septal defect using a novel fully bioabsorbable occluder: multicenter randomized controlled trial.

Although the use of bioabsorbable occluder is expected to reduce the risk of metal occluder-related complications, it has not been approved due to incomplete degradation and new complications. Novel fully bioabsorbable occluders were designed to overcome such limitations. The aim of this study was to investigate the efficacy and safety of a fully biodegradable occluder in patients with ventricular septal defects. 125 patients with perimembranous ventricular septal defect (VSD) larger than 3 mm were screened from April 2019 to January 2020 in seven centers. 108 patients were enrolled and randomized into the bioabsorbable occluder group (n = 54 patients) and nitinol occluder group (n = 54). A non-inferiority design was utilized and all patients underwent transcatheter device occlusion. Outcomes were analyzed with a 24-month follow-up. All patients were successfully implanted and completed the trial. No residual shunt >2 mm was observed during follow-up. Transthoracic echocardiography showed a hyperechoic area corresponding to the bioabsorbable occluder which decreased primarily during the first year after implantation and disappeared within 24 months. Postprocedural arrhythmia was the only occluder-related complication with an incidence of 5.56% and 14.81% for the bioabsorbable and nitinol groups, respectively (P = 0.112). The incidence of sustained conduction block was lower in the bioabsorbable occluder group (0/54 vs. 6/54, P = 0.036) at 24-month follow-up. In conclusion, the novel fully bioabsorbable occluder can be successfully and safely implanted under echocardiography guidance and reduce the incidence of sustained postprocedural arrythmia. The efficacy and safety of this fully biodegradable occluder are non-inferior to that of a traditional nitinol one.

Outcomes following transcatheter closure or surgical repair of coronary-left ventricular fistula: A single-center study with 10-year experience.

BACKGROUND:Coronary arteries drain into the left ventricle, known as coronary-left ventricular fistula (CLVF), an extremely rare anomalous coronary artery disease. Little is known about the outcomes following transcatheter closure (TC) or surgical closure (SC) of CLVF.METHOD:This was a single-center retrospective study including 42 consecutive patients who underwent either the TC or SC procedure from January 2011 to December 2021. The baseline and anatomic characteristics of the fistulas, procedural outcomes, and late outcomes were summarized and analyzed.RESULTS:The mean age was 31.6 ± 16.2 years, with 28 male patients (66.7%). Fifteen patients underwent SC group and the remaining received TC group. There were no differences in age, comorbidities, clinical presentations, and anatomic characteristics between the 2 groups. The procedural success rate was similar (93.3% vs. 85.2%, P = 0.639) without operative and in-hospital mortality in both groups. Notably, patients who underwent TC had a significantly shorter postoperative in-hospital length of stay (2.11 ± 1.49 vs. 7.73 ± 2.37 days, P<0.001). The median follow-up time was 4.6 years (2.5-5.7 years, TC group) and 3.98 years (0.42-7.15 years, SC group), respectively. No difference was observed in the incidence of recanalization of the fistula (7.4% vs. 6.7%, P = 1) and myocardial infarction (0% vs. 0%). Cerebral infarction due to discontinuation of anticoagulants happened to two patients in the TC group. Importantly, thrombotic occlusion of the fistulous tract with patent parent coronary artery was found in 7 patients of the TC group.CONCLUSION:Both transcatheter and SC are safe and effective for patients with CLVF. Thrombotic occlusion is a noteworthy late complication, and its presence indicates the use of anticoagulants lifelong.

PICS/AEPC/APPCS/CSANZ/SCAI/SOLACI: Expert Consensus Statement on Cardiac Catheterization for Pediatric Patients and Adults With Congenital Heart Disease.

[Methodological Study of Reliability Test of Percutaneous Ventricular Assist Device].

Prior to clinical application, reliability of percutaneous ventricular assist devices(pVAD) requires to be tested systematically. Currently, there's a lack of dedicated reliability testing equipment and methodologies for pVAD. Considering the structural and functional aspects of percutaneous ventricular assist devices, this study conducts research on pVAD reliability test engineering. Test setups, clinical conditions, failure modes, effects analysis, and evaluation models have been investigated. A highly feasible methodological approach for percutaneous ventricular assist device reliability assessment has been formed. This study offers valuable insights into standardizing their reliability evaluation in clinical settings.

Study design and rationale of COMPETE: Comparison of the effect of medication therapy in alleviating migraine with patent foramen ovale.

BACKGROUND:Previous studies have examined the impact of antithrombotic agents on Patent Foramen Ovale (PFO) in relation to migraine. However, differences in effectiveness of different antithrombotic agents and traditional migraine medications are not known.METHODS/DESIGN:This study is an investigator-initiated, randomized, multicenter, single-masked (outcomes assessor), and active-controlled parallel-group trial (ClinicalTrials.gov Identifier: NCT05546320), with the objective of evaluating the prevention efficacy of antithrombotic agents compared to first-line migraine medication in PFO patients. The trial involves 1,000 migraine patients with a right-to-left shunt at the atrial level, randomized in a 1:1:1:1 fashion to receive either aspirin 300 mg QD, clopidogrel 75 mg QD, rivaroxaban 20 mg QD, or the active-control metoprolol 25 mg BID. The primary efficacy end point is the response rate, defined as a 50% or greater reduction in the average migraine attack days per month or in the average number of migraine attacks per month at 12-week visit compared to baseline.CONCLUSIONS:The COMPETE trial aims to provide valuable insights into the comparative effectiveness of antithrombotic agents and standard migraine therapies in patients with PFO. This study holds the promise of advancing treatment approaches for individuals having migraines associated with PFO, thus addressing an important gap in current migraine management strategies.

Hemodynamics, anatomy, and outcomes of quadricuspid aortic valves: Multimodality imaging assessment.

BACKGROUND:Quadricuspid aortic valve (QAV) is a rare congenital heart disease with a limited body of literature. This retrospective cohort study investigates QAV morphology, function, and clinical outcomes.METHODS:Echocardiography was used to assess valvular function. Morphological characteristics such as phenotypes, raphe, regurgitant orifice area (ROA), and aortic dilation (diameter >40 ​mm) were assessed by cardiac CT. Patients were followed up for the combined event of all-cause death and aortic valve replacement (AVR).RESULTS:Ninety QAV patients (screened from 322385 CT scans) were included (mean age 55.2 ​± ​13.6 years, 61.1 ​% male). Isolated significant aortic regurgitation (AR) was present in 75.6 ​% of patients. The cohort was dominated by type I (four equal leaflets, 37.8 ​%) and type II (3 larger and 1 smaller leaflets, 42.2 ​%) QAV. Fused raphe was present in 26.7 ​% of patients. ROACT was correlated with AR severity and aortic dilation (41.1 ​%, n ​= ​37). Among patients without AVR at baseline (n ​= ​60), one died and 17 underwent AVR during a median follow-up of 35.0 months (IQR:17.3-62.8). ROACT was associated with an increasing risk of combined event (as a categorical variable with a cut-off of 21.4 ​mm2, HR ​= ​4.25, 95%CI 1.49-12.17, p ​= ​0.007; as a continuous variable (per mm2 increment), HR ​= ​1.04, 95%CI 1.01-1.07, p ​= ​0.003). Additionally, ROACT had incremental prognostic value when added to the AR severity model (area under the receiver-operating characteristic curve increased from 86.8 to 88.4, p ​= ​0.004).CONCLUSION:QAV is characterized by variable anatomy, progressive AR, concomitant cusp fusion and aortic enlargement. ROACT may be a potential ancillary prognostic marker in patients with QAV.

Corrigendum to 'Alerting trends in epidemiology for non-rheumatic degenerative mitral valve disease, 1990-2019: An age-period-cohort analysis for the Global Burden of Disease Study 2019' [Int. J. Cardiol. 395(2024) 131561].

Alerting trends in epidemiology for non-rheumatic degenerative mitral valve disease, 1990-2019: An age-period-cohort analysis for the Global Burden of Disease Study 2019.

BACKGROUND:The global and national burden of rheumatic mitral valve disease (MVD) has been well studied and estimated before. However, little is known about non-rheumatic degenerative MVD. Therefore, this study aimed to assess the trends in non-rheumatic degenerative MVD (NRDMVD) epidemiology, with an emphasis on NRDMVD mortality, leading risk factors, and their associations with age, period, and birth cohort.METHODS:Using the data derived from the Global Burden of Disease Study 2019, including prevalence, mortality, and disability-adjusted life years, we analyzed the burden of NRDMVD and the detailed trends of NRDMVD mortality over the past 30 years in 204 countries and territories by implementing the age-period-cohort framework.RESULTS:Globally, the number of deaths due to NRDMVD increased from 5695.89 (95% uncertainty interval [UI]: 5405.19 to 5895.4) × 1000 in 1990 to 9137.79 (95% UI: 8395.68 to 9743.55) × 1000 in 2019. The all-age mortality rate increased from 106.47 (95% UI: 101.03 to 110.2) per 100,000 to 118.1 (95% UI: 108.51 to 125.93) per 100,000, whereas the age-standardized mortality rate decreased from 170.45 (95% UI: 159.61 to 176.94) per 100,000 to 117.95 (95% UI: 107.83 to 125.92) per 100,000. The estimated net drift of mortality per year was -1.1% (95% confidence interval: -1.17 to -1.04). The risk of death due to NRDMVD increased with age, reaching its peak after 85 years old globally. Despite female patients being associated with lower local drift than male patients, no significant gender differences were observed in the age effect across countries and regions for all sociodemographic index (SDI) levels, except low-SDI regions.CONCLUSIONS:We estimated the global disease prevalence of and mortality due to NRDMVD over approximately a 30-year period. The health-related burden of NRDMVD has declined worldwide; however, the condition persisted in low-SDI regions. Moreover, higher attention should be paid to female patients.

Biodegradable Cardiac Occluder with Surface Modification by Gelatin-Peptide Conjugate to Promote Endogenous Tissue Regeneration.

Transcatheter intervention has been the preferred treatment for congenital structural heart diseases by implanting occluders into the heart defect site through minimally invasive access. Biodegradable polymers provide a promising alternative for cardiovascular implants by conferring therapeutic function and eliminating long-term complications, but inducing in situ cardiac tissue regeneration remains a substantial clinical challenge. PGAG (polydioxanone/poly (l-lactic acid)-gelatin-A5G81) occluders are prepared by covalently conjugating biomolecules composed of gelatin and layer adhesive protein-derived peptides (A5G81) to the surface of polydioxanone and poly (l-lactic acid) fibers. The polymer microfiber-biomacromolecule-peptide frame with biophysical and biochemical cues could orchestrate the biomaterial-host cell interactions, by recruiting endogenous endothelial cells, promoting their adhesion and proliferation, and polarizing immune cells into anti-inflammatory phenotypes and augmenting the release of reparative cytokines. In a porcine atrial septal defect (ASD) model, PGAG occluders promote in situ tissue regeneration by accelerating surface endothelialization and regulating immune response, which mitigate inflammation and fibrosis formation, and facilitate the fusion of occluder with surrounding heart tissue. Collectively, this work highlights the modulation of cell-biomaterial interactions for tissue regeneration in cardiac defect models, ensuring endothelialization and extracellular matrix remodeling on polymeric scaffolds. Bioinspired cell-material interface offers a highly efficient and generalized approach for constructing bioactive coatings on medical devices.

A generalized deep learning model for heart failure diagnosis using dynamic and static ultrasound.

Objective:Echocardiography (ECG) is the most common method used to diagnose heart failure (HF). However, its accuracy relies on the experience of the operator. Additionally, the video format of the data makes it challenging for patients to bring them to referrals and reexaminations. Therefore, this study used a deep learning approach to assist physicians in assessing cardiac function to promote the standardization of echocardiographic findings and compatibility of dynamic and static ultrasound data.Methods:A deep spatio-temporal convolutional model r2plus1d-Pan (trained on dynamic data and applied to static data) was improved and trained using the idea of "regression training combined with classification application," which can be generalized to dynamic ECG and static cardiac ultrasound views to identify HF with a reduced ejection fraction (EF < 40%). Additionally, three independent datasets containing 8976 cardiac ultrasound views and 10085 cardiac ultrasound videos were established. Subsequently, a multinational, multi-center dataset of EF was labeled. Furthermore, model training and independent validation were performed. Finally, 15 registered ultrasonographers and cardiologists with different working years in three regional hospitals specialized in cardiovascular disease were recruited to compare the results.Results:The proposed deep spatio-temporal convolutional model achieved an area under the receiveroperating characteristic curve (AUC) value of 0.95 (95% confidence interval [CI]: 0.947 to 0.953) on the training set of dynamic ultrasound data and an AUC of 1 (95% CI, 1 to 1) on the independent validation set. Subsequently, the model was applied to the static cardiac ultrasound view (validation set) with simultaneous input of 1, 2, 4, and 8 images of the same heart, with classification accuracies of 85%, 81%, 93%, and 92%, respectively. On the static data, the classification accuracy of the artificial intelligence (AI) model was comparable with the best performance of ultrasonographers and cardiologists with more than 3 working years (P = 0.344), but significantly better than the median level (P = 0.0000008).Conclusion:A new deep spatio-temporal convolution model was constructed to identify patients with HF with reduced EF accurately (< 40%) using dynamic and static cardiac ultrasound images. The model outperformed the diagnostic performance of most senior specialists. This may be the first HF-related AI diagnostic model compatible with multi-dimensional cardiac ultrasound data, and may thereby contribute to the improvement of HF diagnosis. Additionally, the model enables patients to carry "on-the-go" static ultrasound reports for referral and reexamination, thus saving healthcare resources.

Transcatheter closure of perimembranous ventricular septal defect using a novel fully bioabsorbable occluder: multicenter randomized controlled trial.

Although the use of bioabsorbable occluder is expected to reduce the risk of metal occluder-related complications, it has not been approved due to incomplete degradation and new complications. Novel fully bioabsorbable occluders were designed to overcome such limitations. The aim of this study was to investigate the efficacy and safety of a fully biodegradable occluder in patients with ventricular septal defects. 125 patients with perimembranous ventricular septal defect (VSD) larger than 3 mm were screened from April 2019 to January 2020 in seven centers. 108 patients were enrolled and randomized into the bioabsorbable occluder group (n = 54 patients) and nitinol occluder group (n = 54). A non-inferiority design was utilized and all patients underwent transcatheter device occlusion. Outcomes were analyzed with a 24-month follow-up. All patients were successfully implanted and completed the trial. No residual shunt >2 mm was observed during follow-up. Transthoracic echocardiography showed a hyperechoic area corresponding to the bioabsorbable occluder which decreased primarily during the first year after implantation and disappeared within 24 months. Postprocedural arrhythmia was the only occluder-related complication with an incidence of 5.56% and 14.81% for the bioabsorbable and nitinol groups, respectively (P = 0.112). The incidence of sustained conduction block was lower in the bioabsorbable occluder group (0/54 vs. 6/54, P = 0.036) at 24-month follow-up. In conclusion, the novel fully bioabsorbable occluder can be successfully and safely implanted under echocardiography guidance and reduce the incidence of sustained postprocedural arrythmia. The efficacy and safety of this fully biodegradable occluder are non-inferior to that of a traditional nitinol one.

Outcomes following transcatheter closure or surgical repair of coronary-left ventricular fistula: A single-center study with 10-year experience.

BACKGROUND:Coronary arteries drain into the left ventricle, known as coronary-left ventricular fistula (CLVF), an extremely rare anomalous coronary artery disease. Little is known about the outcomes following transcatheter closure (TC) or surgical closure (SC) of CLVF.METHOD:This was a single-center retrospective study including 42 consecutive patients who underwent either the TC or SC procedure from January 2011 to December 2021. The baseline and anatomic characteristics of the fistulas, procedural outcomes, and late outcomes were summarized and analyzed.RESULTS:The mean age was 31.6 ± 16.2 years, with 28 male patients (66.7%). Fifteen patients underwent SC group and the remaining received TC group. There were no differences in age, comorbidities, clinical presentations, and anatomic characteristics between the 2 groups. The procedural success rate was similar (93.3% vs. 85.2%, P = 0.639) without operative and in-hospital mortality in both groups. Notably, patients who underwent TC had a significantly shorter postoperative in-hospital length of stay (2.11 ± 1.49 vs. 7.73 ± 2.37 days, P<0.001). The median follow-up time was 4.6 years (2.5-5.7 years, TC group) and 3.98 years (0.42-7.15 years, SC group), respectively. No difference was observed in the incidence of recanalization of the fistula (7.4% vs. 6.7%, P = 1) and myocardial infarction (0% vs. 0%). Cerebral infarction due to discontinuation of anticoagulants happened to two patients in the TC group. Importantly, thrombotic occlusion of the fistulous tract with patent parent coronary artery was found in 7 patients of the TC group.CONCLUSION:Both transcatheter and SC are safe and effective for patients with CLVF. Thrombotic occlusion is a noteworthy late complication, and its presence indicates the use of anticoagulants lifelong.