Interventional Occlusion of Large Patent Ductus Arteriosus in Adults with Severe Pulmonary Hypertension.

(1) Background: the indications for transcatheter closure of large patent ductus arteriosus (PDA) with severe pulmonary hypertension (PH) are still unclear, and scholars have not fully elucidated the factors that affect PH prognosis. (2) Methods: we retrospectively enrolled 134 consecutive patients with a PDA diameter ≥10 mm or a ratio of PDA and aortic >0.5. We collected clinical data to explore the factors affecting follow-up PH. (3) Results: 134 patients (mean age 35.04 ± 10.23 years; 98 women) successfully underwent a transcatheter closure, and all patients had a mean pulmonary artery pressure (mPAP) >50 mmHg. Five procedures were deemed to have failed because their mPAP did not decrease, and the patients experienced uncomfortable symptoms after the trial occlusion. The average occluder (pulmonary end) size was almost twice the PDA diameter (22.33 ± 4.81 mm vs. 11.69 ± 2.18 mm). Left ventricular end-diastolic dimension (LVEDD), mPAP, and left ventricular ejection fraction (LVEF) significantly reduced after the occlusion, and LVEF recovered during the follow-up period. In total, 42 of the 78 patients with total pulmonary resistance >4 Wood Units experienced clinical outcomes, and all of them had PH in the follow-up, while 10 of them had heart failure, and 4 were hospitalized again because of PH. The results of a logistic regression analysis revealed that the postoperative mPAP had an independent risk factor (odds ratio = 1.069, 95% confidence interval: 1.003 to 1.140, p = 0.040) with a receiver operating characteristic curve cut-off value of 35.5 mmHg (p < 0.001). (4) Conclusions: performing a transcatheter closure of large patent ductus arteriosus is feasible, and postoperative mPAP was a risk factor that affected the follow-up PH. Patients with a postoperative mPAP >35.5 mmHg should be considered for targeted medical therapy or should undergo right heart catheterization again after the occlusion.

Optical coherence tomography imaging evidence of thrombus inside the tunnel of Patent Foramen Ovale.

Endovascular Repair for Patent Ductus Arteriosus-Related Endoleak in Aortic and Pulmonary Artery Dissection Patient.

Impact of septal myectomy on diastolic function in patients with obstructive hypertrophic cardiomyopathy.

BACKGROUND:The impact of septal myectomy on diastolic function in patients with obstructive hypertrophic cardiomyopathy is not well studied.METHODS:A transcatheter hemodynamic study was performed before and 3 to 6 months after septal myectomy in 12 patients with obstructive hypertrophic cardiomyopathy (HCM).RESULTS:Postoperative hemodynamic studies were done 4.4±1.2 months after myectomy. The left ventricular outflow tract peak-to-peak gradient decreased from 83.2±43.3 mmHg preoperatively to 11.6±4.3 mmHg after myectomy (P<0.00). The left ventricular diastolic time constant (Tau) was 64.2±26.1 ms before surgery and 42.2±15.7 ms postoperatively (P=0.029). The average left atrial pressure (LAP) decreased from 20.2±7.0 to 12.1±4.5 mmHg after myectomy (P=0.008). Pulmonary artery hypertension was present in 6 patients preoperatively and remained in 2 patients after myectomy. Mean pulmonary artery pressure decreased from 29.3±16.2 to 20±6.7 mmHg after surgery (P=0.05), and the systolic pulmonary artery pressure decreased from 46±26.9 to 30.5±8.3 mmHg (P=0.048). Pulmonary vascular resistance decreased from 5.7±4.1 to 3.6±1.6 wood after surgery (P=0.032).CONCLUSIONS:Septal myectomy improved left ventricular diastolic function and subsequently relieved the right ventricular congestion in patients with obstructive HCM.

Comparison of clinical results between percutaneous closure and surgical repair of ruptured sinus of Valsalva aneurysm.

OBJECTIVES:This study was conducted to investigate whether percutaneous closure of ruptured sinus of Valsalva aneurysm (SVA) is as safe and effective as surgery repair.BACKGROUND:Percutaneous closure of ruptured SVA has been becoming an alternative to the traditional surgical repair recently. The reports regarding direct comparison of these two treatment options are scarce.METHODS:The medical records from the institutional database were retrospectively analyzed. A total of 134 patients were reviewed, including 26 patients undergoing percutaneous closure and 108 patients being treated surgically. To reduce the potential bias, 32 patients from Surgical Repair group were selected by propensity score matching.RESULTS:All the ruptured SVAs were successfully closed in each group. No severe procedure-related complications were found in the perioperative period. After matching, there were no significant differences in the baseline clinical characteristics. The median postoperative hospital stays of Matched group were significantly longer than that of Percutaneous Closure group (7 days vs. 1 day, p < .001). Aortic regurgitation, residual shunt and recurrence of SVAs were common complications in both Percutaneous Closure group and Surgical Repair group.CONCLUSIONS:The appropriately selected patients with ruptured SVA could be treated by percutaneous closure with an acceptable risk of short-term complications. Though surgical repair remains the main treatment option for ruptured SVAs, percutaneous closure could be considered in patients with a small-size rupture and no associated cardiac abnormalities.

Efficacy and safety of a parylene-coated occluder for atrial septal defect: a prospective, multi-center, randomized controlled clinical trial.

BACKGROUND:Nitinol-containing devices are widely used in clinical practice. However, there are concerns about nickel release after nitinol-containing device implantation. This study aimed to compare the efficacy and safety of a parylene-coated occluder vs. a traditional nitinol-containing device for atrial septal defect (ASD).METHODS:One-hundred-and-eight patients with ASD were prospectively enrolled and randomly assigned to either the trial group to receive a parylene-coated occluder (n = 54) or the control group to receive a traditional occluder (n = 54). The plugging success rate at 6 months after device implantation and the pre- and post-implantation serum nickel levels were compared between the two groups. A non-inferiority design was used to prove that the therapeutic effect of the parylene-coated device was non-inferior to that of the traditional device. The Cochran-Mantel-Haenszel chi-squared test with adjustment for central effects was used for the comparison between groups.RESULTS:At 6 months after implantation, successful ASD closure was achieved in 52 of 53 patients (98.11%) in both the trial and control groups (95% confidence interval (CI): [-4.90, 5.16]) based on per-protocol set analysis. The absolute value of the lower limit of the 95% CI was 4.90%, which was less than the specified non-inferiority margin of 8%. No deaths or severe complications occurred during 6 months of follow-up. The serum nickel levels were significantly increased at 2 weeks and reached the maximum value at 1 month after implantation in the control group (P < 0.05 vs. baseline). In the trial group, there was no significant difference in the serum nickel level before vs. after device implantation (P > 0.05).CONCLUSIONS:The efficacy of a parylene-coated ASD occluder is non-inferior to that of a traditional uncoated ASD occluder. The parylene-coated occluder prevents nickel release after device implantation and may be an alternative for ASD, especially in patients with a nickel allergy.

Transbrachial Access for Transcatheter Closure of Paravalvular Leak Following Prosthetic Valve Replacement.

Background: Transcatheter closure of paravalvular leak (PVL) has evolved into an alternative to surgery in high-risk patients. In this study, we introduce a new access for transcatheter closure of PVL and seek to evaluate the feasibility and safety of this access. Methods: We retrospectively analyzed patients undergoing transbrachial access for transcatheter mitral or aortic PVL closure (August 2017-November 2019) at our hospital. All patients underwent puncture of the brachial artery under local anesthesia. Results: The study population included 11 patients, with an average age of 55.91 ± 14.82 years. Ten out of 11 patients were successfully implanted with devices via the brachial artery approach, and one patient was converted to the transseptal approach. The technical success rate of transbrachial access was 90.9%. Mean NYHA functional class improved from 3.1 ± 0.5 before the procedure to 1.9 ± 0.5 after PVL closure. Severe paravalvular regurgitation (PVR) in five patients and moderate PVR in six patients prior to the procedure were significantly reduced to mild in four patients and none in seven patients after the procedure. Complications included one case of pseudoaneurysm and one case of moderate hemolysis aggravation after closure. One patient had an unknown cause of sudden death within 24 h after the procedure. The half-year mortality rate during follow-up was 9.1% (1/11). Conclusions: Transbrachial access for transcatheter closure of PVL may be a feasible and safe treatment and should include well-selected patients. It has several potential advantages of simplifying the procedure process and reducing postprocedural bed rest time.

Percutaneous Closure of a Right Coronary Artery-Left Atrial Fistula Through the Right Brachial Approach.

Transcatheter Closure of Patent Ductus Arteriosus via Different Approaches.

Background: There have been marked advances in devices such as Amplatzer Duct Occluder II (ADO-II) or vascular plug through 5Fr delivery sheath for closure of patent ductus arteriosus (PDA) in the past five decades, making it possible for cardiologists to deliver occluders via different approaches. However, comparisons of these different approaches have not been reported. Therefore, the aim of this study was to summarize and compare the advantages of different approaches for PDA closure, and to guide clinical strategies. Methods: This retrospective study included all patients undergoing transcatheter closure of PDA from 2019 to 2020. Patients were matched by 1:1 propensity score matching (PSM). The retrograde femoral artery approach (FAA) and simple vein approach (SVA) groups were compared with the conventional arteriovenous approach (CAA). Results: The average age of the 476 patients was 21.05 ± 21.15 years. Their average weight was 38.23 ± 24.1 kg and average height was 130.14 ± 34.45 cm. The mean diameter of the PDA was 4.29 ± 2.25 mm. There were 127 men and 349 women, comprising 205 adults and 271 children. Among them, 197 patients underwent CAA, 223 underwent SVA, and 56 underwent retrograde FAA. The diameter in the FAA group was smaller than that in the other two groups, but was similar in adults and children. In the PSM comparison of CAA and SVA, 136 patients with CAA and 136 patients with SVA were recruited. Simple vein approach was associated with markedly reduced length of hospital stay, length of operation, and contrast medium usage as compared with CAA (all P < 0.05). In the PSM comparison of FAA and CAA, 30 patients with CAA and 30 patients with FAA were recruited. The operation duration was longer in the CAA than in the FAA group. There were no significant differences in postoperative complications among groups. Conclusion: Patent ductus arteriosus closure by using the SVA and FAA is safe and effective, and has certain advantages in some respects as compared with CAA.

Personalized Three-Dimensional Printing and Echoguided Procedure Facilitate Single Device Closure for Multiple Atrial Septal Defects.

BACKGROUND:To evaluate the feasibility of using a single device to close multiple atrial septal defects (ASDs) under the guidance of transthoracic echocardiography (TTE) and with the aid of three-dimensional (3D) printing models.METHODS:Sixty-two patients with multiple ASDs were retrospectively analyzed. Thirty of these patients underwent TTE-guided closure (3D printing and TTE group) after a simulation of occlusion in 3D printing models. The remaining 32 patients underwent ASD closure under fluoroscopic guidance (conventional group). Closure status was assessed immediately and at 6 months after device closure.RESULTS:Successful transcatheter closure with a single device was achieved in 26 patients in the 3D printing and TTE group and 27 patients in the conventional group. Gender, age [18.8 ± 15.9 (3-51) years in the 3D printing and TTE group; 14.0 ± 11.6 (3-50) years in the conventional group], mean maximum distance between defects, prevalence of 3 atrial defects and large defect distance (defined as distance ≥7 mm), and occluder size used were similarly distributed between groups. However, the 3D printing and TTE group had lower frequency of occluder replacement (3.8% vs 59.3%, p < 0.0001), prevalence of mild residual shunts (defined as <5 mm) immediately (19.2% vs 44.4%, p < 0.05) and at 6 months (7.7% vs 29.6%, p < 0.05) after the procedure, and cost (32960.8 ± 2018.7 CNY vs 41019.9 ± 13758.2 CNY, p < 0.01).CONCLUSION:The combination of the 3D printing technology and ultrasound-guided interventional procedure provides a reliable new therapeutic approach for multiple ASDs, especially for challenging cases with large defect distance.

Interventional Occlusion of Large Patent Ductus Arteriosus in Adults with Severe Pulmonary Hypertension.

(1) Background: the indications for transcatheter closure of large patent ductus arteriosus (PDA) with severe pulmonary hypertension (PH) are still unclear, and scholars have not fully elucidated the factors that affect PH prognosis. (2) Methods: we retrospectively enrolled 134 consecutive patients with a PDA diameter ≥10 mm or a ratio of PDA and aortic >0.5. We collected clinical data to explore the factors affecting follow-up PH. (3) Results: 134 patients (mean age 35.04 ± 10.23 years; 98 women) successfully underwent a transcatheter closure, and all patients had a mean pulmonary artery pressure (mPAP) >50 mmHg. Five procedures were deemed to have failed because their mPAP did not decrease, and the patients experienced uncomfortable symptoms after the trial occlusion. The average occluder (pulmonary end) size was almost twice the PDA diameter (22.33 ± 4.81 mm vs. 11.69 ± 2.18 mm). Left ventricular end-diastolic dimension (LVEDD), mPAP, and left ventricular ejection fraction (LVEF) significantly reduced after the occlusion, and LVEF recovered during the follow-up period. In total, 42 of the 78 patients with total pulmonary resistance >4 Wood Units experienced clinical outcomes, and all of them had PH in the follow-up, while 10 of them had heart failure, and 4 were hospitalized again because of PH. The results of a logistic regression analysis revealed that the postoperative mPAP had an independent risk factor (odds ratio = 1.069, 95% confidence interval: 1.003 to 1.140, p = 0.040) with a receiver operating characteristic curve cut-off value of 35.5 mmHg (p < 0.001). (4) Conclusions: performing a transcatheter closure of large patent ductus arteriosus is feasible, and postoperative mPAP was a risk factor that affected the follow-up PH. Patients with a postoperative mPAP >35.5 mmHg should be considered for targeted medical therapy or should undergo right heart catheterization again after the occlusion.

Optical coherence tomography imaging evidence of thrombus inside the tunnel of Patent Foramen Ovale.

Endovascular Repair for Patent Ductus Arteriosus-Related Endoleak in Aortic and Pulmonary Artery Dissection Patient.

Impact of septal myectomy on diastolic function in patients with obstructive hypertrophic cardiomyopathy.

BACKGROUND:The impact of septal myectomy on diastolic function in patients with obstructive hypertrophic cardiomyopathy is not well studied.METHODS:A transcatheter hemodynamic study was performed before and 3 to 6 months after septal myectomy in 12 patients with obstructive hypertrophic cardiomyopathy (HCM).RESULTS:Postoperative hemodynamic studies were done 4.4±1.2 months after myectomy. The left ventricular outflow tract peak-to-peak gradient decreased from 83.2±43.3 mmHg preoperatively to 11.6±4.3 mmHg after myectomy (P<0.00). The left ventricular diastolic time constant (Tau) was 64.2±26.1 ms before surgery and 42.2±15.7 ms postoperatively (P=0.029). The average left atrial pressure (LAP) decreased from 20.2±7.0 to 12.1±4.5 mmHg after myectomy (P=0.008). Pulmonary artery hypertension was present in 6 patients preoperatively and remained in 2 patients after myectomy. Mean pulmonary artery pressure decreased from 29.3±16.2 to 20±6.7 mmHg after surgery (P=0.05), and the systolic pulmonary artery pressure decreased from 46±26.9 to 30.5±8.3 mmHg (P=0.048). Pulmonary vascular resistance decreased from 5.7±4.1 to 3.6±1.6 wood after surgery (P=0.032).CONCLUSIONS:Septal myectomy improved left ventricular diastolic function and subsequently relieved the right ventricular congestion in patients with obstructive HCM.

Comparison of clinical results between percutaneous closure and surgical repair of ruptured sinus of Valsalva aneurysm.

OBJECTIVES:This study was conducted to investigate whether percutaneous closure of ruptured sinus of Valsalva aneurysm (SVA) is as safe and effective as surgery repair.BACKGROUND:Percutaneous closure of ruptured SVA has been becoming an alternative to the traditional surgical repair recently. The reports regarding direct comparison of these two treatment options are scarce.METHODS:The medical records from the institutional database were retrospectively analyzed. A total of 134 patients were reviewed, including 26 patients undergoing percutaneous closure and 108 patients being treated surgically. To reduce the potential bias, 32 patients from Surgical Repair group were selected by propensity score matching.RESULTS:All the ruptured SVAs were successfully closed in each group. No severe procedure-related complications were found in the perioperative period. After matching, there were no significant differences in the baseline clinical characteristics. The median postoperative hospital stays of Matched group were significantly longer than that of Percutaneous Closure group (7 days vs. 1 day, p < .001). Aortic regurgitation, residual shunt and recurrence of SVAs were common complications in both Percutaneous Closure group and Surgical Repair group.CONCLUSIONS:The appropriately selected patients with ruptured SVA could be treated by percutaneous closure with an acceptable risk of short-term complications. Though surgical repair remains the main treatment option for ruptured SVAs, percutaneous closure could be considered in patients with a small-size rupture and no associated cardiac abnormalities.

Efficacy and safety of a parylene-coated occluder for atrial septal defect: a prospective, multi-center, randomized controlled clinical trial.

BACKGROUND:Nitinol-containing devices are widely used in clinical practice. However, there are concerns about nickel release after nitinol-containing device implantation. This study aimed to compare the efficacy and safety of a parylene-coated occluder vs. a traditional nitinol-containing device for atrial septal defect (ASD).METHODS:One-hundred-and-eight patients with ASD were prospectively enrolled and randomly assigned to either the trial group to receive a parylene-coated occluder (n = 54) or the control group to receive a traditional occluder (n = 54). The plugging success rate at 6 months after device implantation and the pre- and post-implantation serum nickel levels were compared between the two groups. A non-inferiority design was used to prove that the therapeutic effect of the parylene-coated device was non-inferior to that of the traditional device. The Cochran-Mantel-Haenszel chi-squared test with adjustment for central effects was used for the comparison between groups.RESULTS:At 6 months after implantation, successful ASD closure was achieved in 52 of 53 patients (98.11%) in both the trial and control groups (95% confidence interval (CI): [-4.90, 5.16]) based on per-protocol set analysis. The absolute value of the lower limit of the 95% CI was 4.90%, which was less than the specified non-inferiority margin of 8%. No deaths or severe complications occurred during 6 months of follow-up. The serum nickel levels were significantly increased at 2 weeks and reached the maximum value at 1 month after implantation in the control group (P < 0.05 vs. baseline). In the trial group, there was no significant difference in the serum nickel level before vs. after device implantation (P > 0.05).CONCLUSIONS:The efficacy of a parylene-coated ASD occluder is non-inferior to that of a traditional uncoated ASD occluder. The parylene-coated occluder prevents nickel release after device implantation and may be an alternative for ASD, especially in patients with a nickel allergy.

Transbrachial Access for Transcatheter Closure of Paravalvular Leak Following Prosthetic Valve Replacement.

Background: Transcatheter closure of paravalvular leak (PVL) has evolved into an alternative to surgery in high-risk patients. In this study, we introduce a new access for transcatheter closure of PVL and seek to evaluate the feasibility and safety of this access. Methods: We retrospectively analyzed patients undergoing transbrachial access for transcatheter mitral or aortic PVL closure (August 2017-November 2019) at our hospital. All patients underwent puncture of the brachial artery under local anesthesia. Results: The study population included 11 patients, with an average age of 55.91 ± 14.82 years. Ten out of 11 patients were successfully implanted with devices via the brachial artery approach, and one patient was converted to the transseptal approach. The technical success rate of transbrachial access was 90.9%. Mean NYHA functional class improved from 3.1 ± 0.5 before the procedure to 1.9 ± 0.5 after PVL closure. Severe paravalvular regurgitation (PVR) in five patients and moderate PVR in six patients prior to the procedure were significantly reduced to mild in four patients and none in seven patients after the procedure. Complications included one case of pseudoaneurysm and one case of moderate hemolysis aggravation after closure. One patient had an unknown cause of sudden death within 24 h after the procedure. The half-year mortality rate during follow-up was 9.1% (1/11). Conclusions: Transbrachial access for transcatheter closure of PVL may be a feasible and safe treatment and should include well-selected patients. It has several potential advantages of simplifying the procedure process and reducing postprocedural bed rest time.

Percutaneous Closure of a Right Coronary Artery-Left Atrial Fistula Through the Right Brachial Approach.

Transcatheter Closure of Patent Ductus Arteriosus via Different Approaches.

Background: There have been marked advances in devices such as Amplatzer Duct Occluder II (ADO-II) or vascular plug through 5Fr delivery sheath for closure of patent ductus arteriosus (PDA) in the past five decades, making it possible for cardiologists to deliver occluders via different approaches. However, comparisons of these different approaches have not been reported. Therefore, the aim of this study was to summarize and compare the advantages of different approaches for PDA closure, and to guide clinical strategies. Methods: This retrospective study included all patients undergoing transcatheter closure of PDA from 2019 to 2020. Patients were matched by 1:1 propensity score matching (PSM). The retrograde femoral artery approach (FAA) and simple vein approach (SVA) groups were compared with the conventional arteriovenous approach (CAA). Results: The average age of the 476 patients was 21.05 ± 21.15 years. Their average weight was 38.23 ± 24.1 kg and average height was 130.14 ± 34.45 cm. The mean diameter of the PDA was 4.29 ± 2.25 mm. There were 127 men and 349 women, comprising 205 adults and 271 children. Among them, 197 patients underwent CAA, 223 underwent SVA, and 56 underwent retrograde FAA. The diameter in the FAA group was smaller than that in the other two groups, but was similar in adults and children. In the PSM comparison of CAA and SVA, 136 patients with CAA and 136 patients with SVA were recruited. Simple vein approach was associated with markedly reduced length of hospital stay, length of operation, and contrast medium usage as compared with CAA (all P < 0.05). In the PSM comparison of FAA and CAA, 30 patients with CAA and 30 patients with FAA were recruited. The operation duration was longer in the CAA than in the FAA group. There were no significant differences in postoperative complications among groups. Conclusion: Patent ductus arteriosus closure by using the SVA and FAA is safe and effective, and has certain advantages in some respects as compared with CAA.

Personalized Three-Dimensional Printing and Echoguided Procedure Facilitate Single Device Closure for Multiple Atrial Septal Defects.

BACKGROUND:To evaluate the feasibility of using a single device to close multiple atrial septal defects (ASDs) under the guidance of transthoracic echocardiography (TTE) and with the aid of three-dimensional (3D) printing models.METHODS:Sixty-two patients with multiple ASDs were retrospectively analyzed. Thirty of these patients underwent TTE-guided closure (3D printing and TTE group) after a simulation of occlusion in 3D printing models. The remaining 32 patients underwent ASD closure under fluoroscopic guidance (conventional group). Closure status was assessed immediately and at 6 months after device closure.RESULTS:Successful transcatheter closure with a single device was achieved in 26 patients in the 3D printing and TTE group and 27 patients in the conventional group. Gender, age [18.8 ± 15.9 (3-51) years in the 3D printing and TTE group; 14.0 ± 11.6 (3-50) years in the conventional group], mean maximum distance between defects, prevalence of 3 atrial defects and large defect distance (defined as distance ≥7 mm), and occluder size used were similarly distributed between groups. However, the 3D printing and TTE group had lower frequency of occluder replacement (3.8% vs 59.3%, p < 0.0001), prevalence of mild residual shunts (defined as <5 mm) immediately (19.2% vs 44.4%, p < 0.05) and at 6 months (7.7% vs 29.6%, p < 0.05) after the procedure, and cost (32960.8 ± 2018.7 CNY vs 41019.9 ± 13758.2 CNY, p < 0.01).CONCLUSION:The combination of the 3D printing technology and ultrasound-guided interventional procedure provides a reliable new therapeutic approach for multiple ASDs, especially for challenging cases with large defect distance.