Propensity-matched comparison of balloon-expandable and self-expanding valves for transcatheter aortic valve replacement in a Chinese population.

Background: Balloon-expandable valves (BEV) and self-expanding valves (SEV) for transcatheter aortic valve replacement (TAVR) have shown promising results in Western populations. Herein, we comparatively evaluated their hemodynamics and early clinical outcomes in a Chinese population. Methods: One hundred seventy-eight patients with symptomatic aortic stenosis who had undergone transfemoral TAVR using SEV (n=153; Venus-A, 97; VitaFlow, 56) or BEV (n=25; Sapien3) from September 2020 to April 2021 were retrospectively enrolled, and 25 pairs were propensity-score matched for 10 baseline variables. The primary study outcomes were aortic valve hemodynamics and postoperative complications at discharge and 3-month follow-up. Results: TAVR was successful in all patients. Compared with SEV group, the BEV group had similarly distributed baseline characteristics, procedural time, hospital stay, new pacemaker implantation, and paravalvular regurgitation grade. We also observed that the BEV group had lower rates of balloon pre-dilation (60% vs. 92%, P=0.018), post-dilation (0 vs. 20%, P=0.050) and second valve implantation (0 vs. 24%, P=0.022); higher mean transaortic gradient (14.3±6.1 vs. 10.8±4.9, P=0.030) and proportion of patients with elevated gradients (20% vs. 0, P=0.050) at discharge; and similar rehospitalization, mean transaortic gradient, new pacemaker implantation, and paravalvular regurgitation grade than the SEV group at the 3-month follow-up. There were no deaths in either group. However, the proportion of patients with elevated gradients in SEV group was higher at 3 months than before discharge (24% vs. 0, P=0.022). Conclusions: BEV and SEV for transfemoral TAVR appear comparably safe and effective, with high device success and favorable 3-month clinical outcomes. However, the transaortic gradient and new pacemaker implantation in the SEV group increased during follow-up, warranting larger studies with longer-term follow-up.

A novel double-balloon catheter for percutaneous balloon pulmonary valvuloplasty under echocardiographic guidance only.

BACKGROUND: Percutaneous balloon pulmonary valvuloplasty (PBPV) is the procedure of choice for uncomplicated severe or symptomatic pulmonary stenosis. Echocardiography (echo)-guided PBPV can completely avoid the use of radiation and contrast agents compared to fluoroscopy-guided PBPV. Although we have confirmed that echo-guided PBPV is feasible in humans, the poor visibility of the traditional catheter under echo greatly limits the promotion of this new technology. METHODS: We produced a novel double-balloon catheter to make the catheter easy to be detected by echo through adding a guiding balloon at the distal end of the catheter. Echo-guided PBPV was performed on thirty healthy swine using either a novel catheter or a traditional catheter to evaluate the feasibility and safety of the novel double-balloon catheter. The feasibility was evaluated by the success rate of balloon inflation at the pulmonary valve annulus and the operating time. The safety was evaluated by the frequency of balloon slippage and the incidence of complications. RESULTS: There were no significant between-group differences in terms of weight and the ratio of balloon diameter to pulmonary annulus diameter. The success rate was 93.3% and 60% in the novel and traditional groups, respectively. The novel group had significantly (p<0.05) lower mean procedure time (6.33±6.86min vs 24.8±9.79min) and lower frequency of balloon slippage (0.07±0.26 vs 0.53±0.52), arrhythmia (0.07±0.26 vs 0.47±0.52), and tricuspid regurgitation (6.7% vs 40%) than the traditional group. No myocardial hematoma or pericardial tamponade occurred in the novel catheter group. CONCLUSION: Although further studies and improvements are required, the study results indicate that the novel double-balloon catheter for echo-guided PBPV is feasible and safe.

Multicenter Comparison of Percutaneous and Surgical Pulmonary Valve Replacement in Large RVOT.

BACKGROUND: A percutaneous approach for pulmonary valve replacement (PVR) is a feasible alternative to surgical PVR in selected patients with severe pulmonary regurgitation after repair of tetralogy of Fallot. However, large right ventricular outflow tract (diameter ≥ 25 mm) remains challenging. METHODS: This retrospective multicenter study enrolled consecutive patients with large right ventricular outflow tract who underwent percutaneous PVR (Venus P-valve, Venus MedTech Inc, Hangzhou, China) (n = 35) or surgical PVR (homograft valve; n = 30) between May 2014 and April 2017. Patients were followed up at 1, 3, 6, and 12 months, and yearly thereafter. Main study outcomes were pulmonary valve function and right ventricular function at discharge and midterm follow-up. RESULTS: PVR was successful in all patients. Percutaneous compared with surgical PVR group had: similarly distributed baseline characteristics; shorter hospitalization, intensive care unit stay, and endotracheal intubation duration; lower cost; lower pulmonary valve gradient before discharge; lower pulmonary valve regurgitant grade (mean difference, -0.63; 95% CI -1.11 to -0.20, P = .022), pulmonary valve gradient (mean difference, -5.7 mm Hg; 95% CI -9.4 to -2.2 mm Hg, P = .005), and right ventricular end-diastolic volume index (mean difference, -9.5 mL/m2; 95% CI -16.9 to -3.1 mL/m2, P = .022); and greater right ventricular ejection fraction (mean difference, 5.4%; 95% CI 2.4%-8.3%, P = .002) at median 36 months follow-up, without deaths in either group. CONCLUSIONS: Percutaneous PVR using Venus P-valve appeared to be a safe, efficacious and minimally invasive alternative to surgical PVR in selected patients with large right ventricular outflow tract yielding better right ventricular and pulmonary valve function at midterm follow-up.

Percutaneous closure of patent foramen ovale under transthoracic echocardiography guidance-midterm results.

BACKGROUND: Conventional percutaneous closure of patent foramen ovale (PFO) is usually performed under the guidance of fluoroscopy. Whether closure of PFO under transthoracic echocardiography (TTE) guidance only is safe and effective is unknown. The present study therefore aimed to assess the safety and efficacy of percutaneous closure of PFO under TTE guidance only. METHODS: This study retrospectively enrolled a total of 52 consecutive patients (55.8% male, mean age 34.0±13.0 years, range, 10-59 years) with PFO treated at our institution from June 2015 to September 2017 by percutaneous closure under echocardiographic guidance only. The patients mean body weight was 58.7±10.8 kg. Patients underwent follow-up by TTE immediately post procedure by electrocardiogram and TTE at 1, 3, 6 and 12 months after discharge and annually thereafter, and by clinical evaluation at all time points. RESULTS: Of the 52 patients, 47 (90.4%) were successfully treated by percutaneous closure under TTE guidance. The mean procedure duration (from puncture to sheath removal) was 21.0±6.2 (range, 11-33) minutes. A trivial residual shunt which disappeared 24 hours later was observed in only 1 (1.9%) patient immediately post procedure. Median hospital stay was 3.0 days without severe complications such as peripheral vascular injury or cardiac perforation at discharge. At median 15.5 (11.3, 18.0) months follow-up, there were no complications such as death, stroke, transient ischemic attack (TIA) and residual shunt. CONCLUSIONS: In this single center study of mostly lean patients, percutaneous closure of PFO under TTE guidance as the only imaging tool appeared effective at midterm follow-up, while avoiding radiation exposure, endotracheal intubation and contrast agent use.

A Novel Wire Is Effective for Echo-Guiding Percutaneous Atrial Septal Defect Closure: A Preclinical Study.

Objective: To assess the effectiveness of a novel ultrasound wire for echo-guiding percutaneous atrial septal defect (ASD) closure in a sheep model. Methods: After right lateral thoracotomy, ASDs were created in 20 sheep by transseptal needle puncture followed by balloon dilatation. Animals were evenly randomized into 2 groups to undergo ASD closure using echography as the only imaging tool with either COOK wire (control group) or new ultrasound wire (study group). The total procedural time, passing time (time needed for the guide wire to enter the left atrium), frequency of delivery sheath dropping into the right atrium, frequency of arrhythmias, and 1-week rate of complications were compared between the two groups. Results: All animals survived defect creation procedures uneventfully. ASD devices were successfully implanted in all sheep. Compared with the control group, the study group had significantly (P < 0.05) lower mean procedure time (15.36 ± 4.86 versus 25.82 ± 7.85 min), lower mean passing time (2.69 ± 0.82 versus 5.58 ± 3.34 min), lower frequency of the guide wire dropping into the right atrium (0% versus 40%), and lower frequency of atrial (4.41 ± 2.61 versus 9.60 ± 3.68) or ventricular premature contractions (0.75 ± 0.36 versus 1.34 ± 0.68), respectively, without serious complications up to one week. Conclusion: The novel ultrasound specialized guide wire was effective in echo-guiding percutaneous ASD closure.

Feasibility and effectiveness of percutaneous balloon mitral valvuloplasty under echocardiographic guidance only.

OBJECTIVE: Percutaneous balloon mitral valvuloplasty (PBMV) is the treatment of choice in patients with isolated mitral stenosis. This study aimed to assess the feasibility of PBMV under echocardiography guidance only of isolated mitral stenosis (MS). METHODS: From October 2016 to Dec 2017, 20 consecutive patients with severe MS underwent PBMV with echocardiography as the only imaging modality at a single center. Outpatient follow-up including chest radiography, electrocardiography, and transthoracic echocardiography was conducted at 1, 3,6, and 12 months after the procedure. RESULTS: All 20 patients successfully underwent PBMV under echocardiography guidance without radiation and contrast agent. Among them, 2 patients were pregnant, 5 had chronic renal failure, and 1 had history of allergy to contrast. Mitral transvalvular pressure gradient measured at catheterization dropped from 13.35 ± 2.85 mm Hg to 5.10 ± 1.17 mm Hg (P < .01). Mitral valve area increased from 0.82 ± 0.10 cm2 pre-PBMV to 1.88 ± 0.24 cm2 post-PBMV (P < .01). Mean balloon diameter was 26.63 ± 0.93 mm. Mild mitral regurgitation developed in 6 patients. Mean follow-up duration was 6.27 ± 3.12 months. At last follow-up, mitral valve area remained high (1.71 ± 0.14 cm2 ) and mean transmitral pressure gradient low (6.07 ± 1.03 mm Hg). No pericardial effusion or peripheral vascular complications occurred. CONCLUSION: In this small experience, PBMV could be successfully performed under only echocardiography guidance and appeared safe and effective while avoiding radiation and contrast agent use.

Hybrid Balloon Valvuloplasty for the Treatment of Severe Congenital Aortic Valve Stenosis in Infants.

BACKGROUND: Surgical or percutaneous interventional treatment of severe congenital aortic valve stenosis (CAS) in early infancy remains challenging. This single-center, retrospective study analyzed midterm outcomes of a hybrid balloon valvuloplasty procedure through the ascending aorta by way of median sternotomy, including cases with improved technique. METHODS: Included were 45 consecutive infants (aged <90 days) with CAS and selected for biventricular repair who underwent hybrid balloon valvuloplasty in a hybrid or ordinary operating room from October 2010 to March 2016. Patients were assessed at 1, 3, 6, and 12 months and yearly thereafter. RESULTS: Hybrid balloon valvuloplasty was successful in all patients, with the last 8 treated in an ordinary operating room under only echocardiography guidance with a new sheath. Thirty-two patients were successfully rescued from low heart rate or left ventricular systolic dysfunction, or both, by cardiac massage under direct visualization; none required cardiopulmonary bypass. The degree of new aortic insufficiency was mild in 7 patients and changed from mild to moderate in 1 patient. Aortic valve pressure gradient decreased from 70.6 ± 17.5 mm Hg preoperatively to 15.2 ± 4.2 mm Hg immediately postoperatively (p < 0.001). Fluoroscopy time was 4.8 ± 2.3 minutes. At a median of 32.1 months (range, 1 to 68 months) follow-up, all patients were alive and healthy. Aortic valve pressure gradient remained low (19.1 ± 5.2 mm Hg). Left ventricular ejection fraction increased from 0.515 ± 0.134 (range, 0.21 to 0.70) preoperatively to 0.633 ± 0.035 (range, 0.58 to 0.75; p < 0.001). No aortic insufficiency developed, and no patient required reintervention. CONCLUSIONS: For infants with severe CAS, hybrid balloon valvuloplasty through the ascending aorta by way of a median sternotomy appears efficacious and safe up to midterm follow-up.

Perventricular device closure of perimembranous ventricular septal defect: effectiveness of symmetric and asymmetric occluders.

Objectives: To assess safety and effectiveness of symmetric and asymmetric occluders in perventricular device closure without cardiopulmonary bypass of perimembranous ventricular septal defects (pmVSDs). Methods: The present retrospective study enrolled 581 patients who underwent perventricular device closure of pmVSDs under transoesophageal echocardiography guidance from May 2011 to April 2016, and outpatient electrocardiography and transthoracic echocardiography assessments at 1, 3, 6 and 12 months, and yearly thereafter. Results: The overall success rate of device implantation was 92.6% (43 surgical conversions immediately). Between patients receiving symmetric ( n = 353) and asymmetric ( n = 185) occluders, there were no significant differences in age, weight and defect diameter distributions; however, both before discharge and at mean 28.6 ± 21.2 (range, 1-60)-month follow-up, the symmetric group had lower rates of trivial residual shunt (5.7% vs 11.4%, P = 0.018; and 0.8% vs 5.9%, P = 0.001) and bundle branch block (0.8% vs 5.4%, P = 0.002; and 0.6% vs 3.8%, P = 0.009); and at follow-up, the asymmetric group had lower residual shunt (47.6% vs 85.0%, P = 0.020) and similar branch block (30.0% vs 33.3%, P = 1.000) disappearance rates. There were no severe complications, i.e. aortic regurgitation, malignant arrhythmias, haemolysis or device dislocation. Conclusions: Perventricular device closure of pmVSDs appears safe and effective with symmetric and asymmetric occluders. However, the lower residual shunt disappearance and higher branch block incidence rates for asymmetric occluders would favour more proactive conversion to surgical repair immediately when residual shunt is present intraoperatively.

First-in-Human Percutaneous Balloon Pulmonary Valvuloplasty Under Echocardiographic Guidance Only.

OBJECTIVE: The objective of this study was to assess the feasibility of percutaneous balloon pulmonary valvuloplasty (PBPV) under echocardiographic guidance only. SETTING: PBPV has become the preferred choice for pulmonary valve stenosis (PS). We report the first-in-human successful PBPV under only echocardiography guidance for isolated PS. METHODS: From March 2013 to December 2014, 34 patients with congenital PS underwent PBPV with echocardiography as the only imaging modality in the ordinary operation room or catheter lab. Outpatient follow-up including chest radiography, electrocardiography, and transthoracic echocardiography (TTE) was conducted at 1, 3, 6, and 12 months. RESULTS: All 34 patients successfully underwent PBPV under echocardiography guidance without radiation and contrast agent. The pulmonic transvalvular pressure gradient dropped from 62.8 ± 10.1 mm Hg to 14.7 ± 4.2 mm Hg measured on catheterization (P < .05). The balloon diameter/pulmonary annulus diameter ratio was 1.34 ± 0.07. Slight regurgitation of the pulmonary valve occurred in five patients and mild pulmonary regurgitation occurred in one patients. The pulmonic transvalvular pressure gradient measured on TTE 12 months after the procedure was 14.1 ± 4.6 mm Hg. No pericardial effusion and peripheral vascular complications occurred. CONCLUSION: This study demonstrated that PBPV can be successfully performed under only echocardiography guidance and appears safe and effective while avoiding radiation and contrast agent use.

Echocardiographic Guided Closure of Perimembranous Ventricular Septal Defects.

BACKGROUND: Transesophageal echocardiogram-guided minimally invasive periventricular device closure of perimembranous ventricular septal defects (pmVSDs) without cardiopulmonary bypass is a treatment option for pmVSDs. We introduce our improvements to this technique and mid-term follow-up results. METHODS: From May 2011 to May 2014, 187 patients with pmVSDs aged 6 months to 31 years (8.2 ± 10.2 years) were enrolled in this study. The procedure was performed through a new transthoracic approach of 1 to 2 cm without sternotomy. Device selection and the operative procedure were monitored by transesophageal echocardiogram. The patients underwent follow-up examinations of echocardiography and electrocardiogram at 1 month, 3 months, 6 months, and 1 year after the operation and annually thereafter. RESULTS: The defects were closed successfully in 179 patients (95.7%), and in 8 patients the operation was converted to conventional surgical repair. Six patients (3.4%) had an incomplete right bundle branch block. One patient experienced an intermittent complete atrioventricular block on the fourth day after the operation, and sinus rhythm was restored by corticosteroid therapy after 5 days. A trivial residual shunt was observed in 8 patients (4.5%) during the procedure. The average hospital stay was 3.1 ± 0.9 days. Follow-up in all patients ranged from 1 month to 36 months (median, 12.6 months), and aortic regurgitation, malignant arrhythmia, and device dislocation were not observed in any patients. However, 3 patients (1.7%) still had a trivial residual shunt at their last follow-up. CONCLUSIONS: Periventricular device closure through a modified transthoracic approach without sternotomy is a potentially safe and effective treatment option for pmVSDs. Controlled studies with long-term follow-up are necessary.

Percutaneous Closure of Atrial Septal Defects Under Transthoracic Echocardiography Guidance Without Fluoroscopy or Intubation in Children.

OBJECTIVE: Demonstrate the benefits of percutaneous atrial septal defect (ASD) closure under guidance of transthoracic echocardiography (TTE) without fluoroscopy. METHODS: From February 2013 to April 2014, 127 consecutive patients with an isolated type II ASD were recruited to undergo percutaneous closure under either TTE (n = 60, TTE group) or TEE (n = 67, TEE group) guidance. The TTE group received local anesthesia or sedation with propofol, and the TEE group received general anesthesia with endotracheal intubation. Follow-up examinations were performed for both groups at 1 month, 3 months, 6 months, and 1 year after discharge and annually thereafter. RESULTS: The TTE group had a significantly shorter procedure time and respirator ventilation duration than the TEE group. The dose of propofol required, the cost, and the pharyngeal complication rate were significantly lower in the TTE group than in the TEE group. The median follow-up of 11.6 months was uneventful in all patients. CONCLUSIONS: Percutaneous ASD closure with TTE guidance as the only imaging tool avoids fluoroscopy, endotracheal intubation, and probe insertion and is associated with a satisfactory procedural success rate and lower costs. This procedure is a safe and reliable treatment for ASD.

Hybrid balloon valvuloplasty through the ascending aorta via median sternotomy in infants with severe congenital valvular aortic stenosis: feasibility of a new method†.

OBJECTIVES: To evaluate a novel hybrid balloon valvuloplasty procedure for severe congenital valvular aortic stenosis in low-weight infants, performed through the ascending aorta via median sternotomy. METHODS: Eighteen infants (<90 days of age) with severe congenital aortic stenosis were included in this study. Hybrid balloon valvuloplasty procedures were performed in a hybrid operating room. Patients were followed up at 3 months, 6 months, 1 year and then annually following the procedure. RESULTS: The hybrid balloon valvuloplasty procedure was successful in all patients. Eight patients were successfully rescued from left ventricular systolic dysfunction by cardiac compression under direct vision. The aortic valve pressure gradient decreased from 80.3 ± 20.8 mmHg preoperatively to 16.0 ± 3.6 mmHg immediately postoperatively (P < 0.001). None of the patients developed significant aortic insufficiency. The fluoroscopy time was 6.2 ± 2.9 min. Intraoperative blood transfusions and pacing were not required. The patients were all alive and healthy at the end of the follow-up period (mean 21.3 months; range 3-41 months), and the aortic valve pressure gradient remained low (21.7 ± 5.3 mmHg). Reintervention was not required in any of the patients. CONCLUSIONS: Hybrid balloon valvuloplasty through the ascending aorta via median sternotomy is an effective and safe procedure for infants with severe congenital aortic stenosis.

Modified anastomosis for repair of supracardiac total anomalous pulmonary venous connection in infants.

Recurrent pulmonary venous obstruction after repair of total anomalous pulmonary venous connection (TAPVC) is usually restricted to the anastomosis between the pulmonary venous confluence and the left atrium. We describe a modified technique for repair of supracardiac TAPVC in infants. An L-shaped incision of left atrium is utilized and the right-sided anastomosis is enlarged by using autologous pericardium to create a large and tension-free anastomosis.