Transcatheter aortic valve replacement is an effective treatment for aortic stenosis currently, especially in elderly, surgical high-risk, and surgical procedures-intolerant patients with severe aortic stenosis. After several generations of updates in design and function, the self-expandable valves have shown significant efficacy in treating aortic stenosis patients with bicuspid aortic valve, bioprosthetic valve failure or small annulus, and superiority in terms of valve durability, and the favorable hemodynamic outcomes could translate into clinical endpoint benefit. This literature review summarizes the advantages and recent advances of the self-expandable valves in transcatheter aortic valve replacement.
Objective To evaluate the safety and efficacy of transcatheter aortic valve replacement (TAVR) using the SAPIEN 3 system. MethodsThis was a prospective, multicenter, single arm study in 4 centers in China. The clinical data of 50 patients with high-risk symptomatic severe aortic stenosis who underwent TAVR using the SAPIEN 3 system from June 2017 to June 2019 were analyzed, including 27 males and 23 females aged 76.8±6.1 years. ResultsThe Society of Thoracic Surgeon score was 6.0%±2.8%. Totally, 20.0% of patients had severe bicuspid aortic stenosis. The operation time was 41.8±16.5 min and the hospital stay time was 8.5±5.0 d. At the postoperative 30-day follow-up, no all-cause mortality occurred and the device success rate was 89.5%. Major vascular complications occurred in one (2.0%) patient, stroke in one (2.0%) patient, new pacemaker implantation in one (2.0%) patient, as well as coronary artery obstruction in one (2.0%) patient. There was no moderate or moderate/severe paravalvular leak. The aortic pressure gradient was decreased from 49.2±16.2 mm Hg before the operation to 12.4±4.6 mm Hg at the postoperative 30-day follow-up, and the valvular area was increased from 0.6±0.3 cm2 to 1.3±0.3 cm2 (P<0.01). Moreover, the New York Heart Association classification in 83.7% of the patients was improved during the follow-up. ConclusionThis pre-marketing multicenter study has demonstrated the safety and effectiveness of transfemoral TAVR with the SAPIEN 3 transcatheter valve system in Chinese aortic stenosis patients at high risk for surgery.
ObjectiveTo analyze the factors influencing the occurrence of subclinical leaflet thrombosis (SLT) after percutaneous aortic valve replacement using balloon-expandable valve (Sapien3, S3). Methods Retrospective analysis was made on 62 patients with severe aortic stenosis undergoing percutaneous aortic valve replacement using S3 in our center from September 2020 to June 2022. Patients with a history of vascular atherosclerosis or with significant increase or insignificant decrease of aortic valve flow or gradient pressure during follow-up were selected for CT examination. Results A total of 26 patients were finally included, with an average age of 70.31±8.90 years, and the male proportion was higher (n=15, 57.69%). Among them, 5 patients had SLT. Compared with the non-SLT group, patients in the SLT group were older (68.52±8.80 years vs. 77.80±4.66 years, P=0.007). The age factor (≥75 years) and the diameter of the ascending aorta were associated with SLT (both P<0.05). Conclusion The incidence of SLT is higher in the elderly patients. It is speculated that SLT is related to the characteristics of short balloon dilation valves and low blood flow dynamics of valve racks.
ObjectiveTo analyze the efficacy and safety of percutaneous balloon pulmonary valvuloplasty (PBPV) for pulmonary valve stenosis guided by ultrasound.MethodsFrom March 2016 to July 2019, 32 patients with pulmonary valve stenosis were treated in our hospital. There were 19 males and 13 females with an average age of 1-12 (6.2±3.1) years and weight of 7-45 (22.7±9.2) kg. The clinical efficacy of PBPV guided by transthoracic echocardiography (TTE) was evaluated.ResultsThe transvalvular pressure gradient (PG) of the patients before PBPV was 65.4±11.9 mm Hg. All patients successfully received PBPV under TTE guidance. The PG was 19.7±4.0 mm Hg immediately after operation, which was significantly decreased (P<0.001). All patients survived without any serious complications. The PG values at 3 months, 6 months and 12 months after operation were 18.4±4.0 mm Hg, 16.4±3.9 mm Hg, 15.2±3.3 mm Hg, respectively, which were significantly lower than that before the operation (P<0.001).ConclusionPBPV guided by echocardiography is safe and effective in the treatment of pulmonary valve stenosis with low complications rate.
ObjectiveTo evaluate the safety and effect of balloon sinuplasty for the treatment of chronic sphenoid sinusitis. MethodsFrom November 2011 to March 2013, 17 patients received balloon catheter dilation of sinus ostia. All the patients were followed up for 12 months postoperatively and the therapeutic effect was evaluated. ResultsAt the end of the following-up, the clinical symptoms of all the patients got relieved. Through nasal endoscopic examination, we found that apertura sphenoidalis developed well in 15 cases, sinus mucosa edema in one case, sinus stenosis in one case, and no postoperative complications occurred. The mean visual analogue scale (VAS) scores were 5.21±1.51 preoperatively and 3.23±1.34, 3.35±1.41, 3.58±1.46 at 3, 6 and 12 months postoperatively. The mean sino-nasal outcome test-20 scores were 12.50±1.96 preoperatively and 7.30±1.79, 7.64±1.93, 7.77±2.02 at 3, 6, 12 months postoperatively. The mean Lund-Kennedy endoscopic mucosal morphology scores were 3.51±1.47 preoperatively and 1.77±1.11, 1.88±1.01, 2.00±0.97 at 3, 6, 12 months postoperatively. The mean CT scores were 1.57±1.06 preoperatively and 0.85±0.62 at 12 months postoperatively. Compared with the preoperative scores, the postoperative scores were significantly different. ConclusionBalloon sinuplasty is worthy of clinical application for its advantages of good clinical effect and safety.
Objective A meta-analysis was performed for a comparison of outcomes between surgery and balloon angioplasty (BA) for native coarctation of the aorta (NCA) in pediatric patients. Methods Electronic databases, including PubMed, EMbase, Medline, Cochrane Library, Weipu Data, Wanfang Data and CNKI were searched systematically for the literature aimed mainly at comparing the therapeutic effects for NCA administrated by surgery and BA. Corresponding data sets were extracted and two reviewers independently assessed the methodological quality. Results Ten studies meeting the inclusion criteria were included, involving a total of 723 subjects. It was observed that compared with BA, surgery was significantly associated with a lower incidence of recoarctation (OR, 0.43; 95%CI, 0.30–0.63; P<0.001), repeat intervention due to recoarctation (OR, 0.40; 95%CI, 0.27–0.61;P<0.001) and lower residual transcoarctation gradient in mid to long term follow up (WMD –0.85; 95%CI, –12.34 to –3.76;P<0.001). Compared with BA, surgery was significantly associated with a longer hospitalization time (WMD, 19.40; 95%CI, 15.82–22.99;P<0.001). Incidence of aneurysm formation (OR, 0.64; 95%CI, 0.26–1.57;P=0.33), complications(OR, 1.77; 95%CI, 0.95–3.28; P=0.07), perioperative mortality (OR, 2.57; 95%CI, 0.87–7.61, P=0.09) and immediate transcoarctation residual gradient (WMD –1.66; 95%CI, –4.23–0.90; P=0.2) were not statistically different between surgery and BA. Conclusions Compared with BA, surgery was significantly associated with a lower incidence of recoarctation, repeat intervention due to re-CoA and residual transcoarctation gradient in mid to long term follow up. On the contrary, BA was significantly associated with a shorter hospitalization time. Incidence of aneurysm formation, perioperative mortality, complications and immediate transcoarctation residual gradient were similar between surgery and BA.
Objective To evaluate the effectiveness and the value of balloon kyphoplasty in treating aged osteoporosis thoracolumbar vertebrae burst fracture. Methods Between January 2003 and January 2008, 36 thoracolumbar vertebrae burst fracture patients were treated. There were 15 males and 21 females with an average age of 65.4 years (range, 59-72 years). Fourteen cases had no obvious history of trauma, 19 had a history of sl ight trauma, and 3 had a history of severe trauma. Forty vertebral bodies were involved, including 1 T7, 3 T9, 8 T10, 10 T12, 9 L1, 7 L2, and 2 L4. All patients displayed local pain and osteoporosis by bone density measurement with no neurological symptom of both lower limbs. Balloon kyphoplasty through unilateral (31 cases) or bilateral (5 cases) vertebral pedicles with polymethylmethacrylate was performed at the injection volume of (3.46 ± 0.86) mL per vertebral body. Before and after operation, the anterior height and posterior height of fractured vertebral body and the sagittal displacement were measured. Results Two cases had intraoperative cerebrospinal fluid leakage; 1 case had no remission of waist-back pain and pain was released after symptomatic treatment. All 36 patients were followed up 2.3 years on average (range, 1.5-4.0 years). No cement leakage was found with good diffusion of cement on X-ray film. The restoration of the height of vertebral bodies was satisfactory without nerve compression symptoms and other compl ications. The Visual Analogue Score at last follow-up (2.34 ± 1.03) was significantly lower than that of preoperation (6.78 ± 1.21), (P lt; 0.05). The compressive percentage of anterior height (19.80% ± 1.03%) of fractured vertebral body after operation was significantly lower than that before operation(25.30% ± 2.50%), (P lt; 0.05). There was no significant difference in posterior compressive percentage and sagittal displacement between pre- and post- operation (P gt; 0.05). Conclusion Based on roentgenographic scores, balloon kyphoplasty is selectively used to treat aged osteoporosis thoracolumbar vertebrae burst fracture, and the radiographic and cl inical results were satisfactory.