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.
Objective To analyse the correlative factors of secondary vertebral fracture after percutaneous kyphoplasty (PKP) in treatment of osteoporotic vertebral compression fracture (OVCF) at different levels (adjacent and/or nonadjacent levels). Methods Between December 2002 and May 2008, 84 patients with OVCF were treated with PKP, and the cl inical data were analysed retrospectively. There were 11 males and 73 females with an average age of 70.1 years (range, 55-90 years). All patients were followed up 24-96 months (mean, 38 months). Secondary vertebral fracture occurred in 12 cases at 3-52 months after PKP (secondary fracture group), no secondary fracture in 72 cases (control group) at over 24months. The preoperative bone mineral density, postoperative vertebral height compression rate, postoperative Cobb angle, amount of injected bone cement per vertebra, puncture pathway (uni- or bilateral puncture), age, gender, number of fracture segment, and cement intradiscal leakage were compared between 2 groups to find correlative factors of secondary vertebral fractures. Results There was no significant difference in preoperative bone mineral density, postoperative vertebral height compression rate, postoperative Cobb angle, amount of injected bone cement per vertebra, puncture pathway, age, gender, and number of fracture segment between 2 groups (P gt; 0.05). But the incidence of cement intradiscal leakage was much higher in secondary fracture group than in control group (χ2=5.294, P=0.032). Conclusion Cement intradiscal leakage may be the correlative factor of secondary vertebral fracture after PKP in OVCF.
目的 探讨4种输尿管镜入镜方法的成功率及对输尿管口的损伤。 方法 回顾性分析2008年7月－2011年3月间行输尿管镜手术的患者共553例，按其入镜方法分为4组，分别采用球囊扩张法、灌注泵加压灌注入镜法、内旋法及倒入法进行输尿管镜操作。分析其成功率及对输尿管口的损伤。 结果 气囊扩张法成功率为95%，但对输尿管口的损伤率为100%；灌注泵加压法成功率为67.5%，输尿管口损伤率为87.0%；内旋法的成功率为87.9%，损伤率为50.0%；倒入法成功率91.0%，对输尿管口损伤率为22.2%。4种方法中，灌注泵加压法一次性成功率最低，与其余3种方法比较，差异均有统计学意义（P＜0.008）；其余3种方法间一次性成功率差异无统计学意义（P＞0.008）。对输尿管口的损伤率，4种方法组间两两比较的差异均有统计学意义（P＜0.008），其中气囊扩张法损伤率最高，倒入法最低。 结论 倒入法是4种方法中成功率较高且损伤小的一种方法。
Objective To evaluate the safety and early-stage efficacy of transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) using a new generation balloon-expandable (BE) valve by collecting the baseline and follow-up data. Methods We retrospectively reviewed the clinical data of severe AS patients who received TAVR with BE valve (Sapien 3) in Fuwai Hospital from September 2020 to June 2022. We collected the echocardiographic data as well as follow-up results at post-procedure, 1, 3, 6 and 12 months. According to the Sievers classification criteria, the patients were divided into a normal group and a bicuspid aortic valve group. Results Finally 62 patients were collected, including 31 females and 31 males with an average age of 71.44±9.17 years. There was 61 patients implanted successfully with BE valve and only 1 was transferred to surgical replacement. There was no mortality or severe complications. Echocardiographic assessment showed significant reduction of the pressure gradient (P＜0.001) and the effect was consistent to postoperative 12 months. After the treatment of patients with different aortic valve morphology using balloon dilation, the condition of valve stenosis improved. ConclusionThe use of BE valves has good safety and early efficacy in patients with severe AS of different valve morphology.
ObjectiveTo discuss outcomes of arch reintervention for post-repair recoarctation in children.MethodsFrom 2009 to 2019, 48 patients underwent reintervention for post-repair recoarctation in Shanghai Children’s Medical Center. Of the 48 patients, 22 patients had surgical repair, 25 patients had balloon angioplasty (BA), and 1 patient had a stent implantation. The clinical data were analyzed, and the difference in time-to-event distribution between the surgical group and the BA group was determined by a log-rank test.ResultsThe median age at reintervention was 15.0 months (range, 3.0 months-15.1 years). The median weight at reintervention was 9.8 kg (range, 3.0-58.0 kg). The time to reintervention after initial repair was 12.5 months (range, 2.0 months-7.8 years). One patient (2.1%) died in hospital and 1 patient (2.1%) experienced arrhythmia after surgical repair. One late mortality (2.1%) occurred after surgical reintervention. One patient (2.1%) experienced aortic dissection after BA. No patient died after BA. Freedom from residual coarctation or new recurrences was 66.7%, 61.3%, and 56.9%, respectively, at 1, 2, and 5 years after reintervention. Freedom from residual coarctation or new recurrences was 90.0%, 81.8%, and 70.1%, respectively, at 1, 2, and 5 years after surgical repair. Freedom from residual coarctation or new recurrences was 52.0%, 48.0%, and 48.0%, respectively, at 1, 2, and 5 years after BA. Compared with BA, surgery-based reintervention had a lower incidence of residual coarctation or recurrences (χ2=4.400, P=0.036).ConclusionReintervention for recoarctation has favorable early outcomes. Compared with balloon angioplasty, surgical repair has a more lasting effect in relieving the recoarctation.
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.
ObjectiveTo discuss the operation skill and clinical effects of using domestic balloon-expandable Prizvalve® transcatheter "valve-in-valve" to treat the degenerated bioprosthesis in the tricuspid position.MethodsAll the admitted surgical tricuspid valve bioprosthetic valve replacement patients were evaluated by computerized tomography angiography (CTA), ultrasound, and 3D printing technology, and 2 patients with a degenerated bioprosthesis were selected for tricuspid valve "valve-in-valve" operation. Under general anesthesia, the retro-preset Prizvalve® system was implanted into degenerated tricuspid bioprosthesis via the femoral vein approach under the guidance of transesophageal echocardiographic and fluoroscopic guidance.ResultsTranscatheter tricuspid valve implantation was successfully performed in both high-risk patients, and tricuspid regurgitation disappeared immediately. The operation time was 1.25 h and 2.43 h, respectively. There was no serious complication in both patients, and they were discharged from the hospital 7 days after the operation.ConclusionThe clinical effect of the degenerated tricuspid bioprosthetic valve implantation with domestic balloon-expandable valve via femoral vein approach "valve-in-valve" is good. Multimodality imaging and 3D printing technology can safely and effectively guide the implementation of this innovative technique.
Objective To explore the effect of endovascular treatment guided by ultrasonography combined with portosystemic shunts on the patients with Budd-Chiari Syndrome （BCS）.Methods The clinical data of 136 patients with BCS treated by balloon angioplasty and stent implantation guided by Doppler ultrasonography in our hospital from January 1995 to January 2011 were retrospectively analyzed.After balloon angioplasty,53 patients were treated by inferior vena cava （IVC） stent implantation and 31 patients with hepatic venous occlusion underwent portosystemic shunts （PSSs） at one week after endovascular treatment.The long-and short-term effects after treatment were studied.Results After endovascular procedures,the IVC pressure of patients significantly decreased （P＜0.01）,while IVC diameter, flow velocity in the lesion,and right atrial pressure of patients showed significant increase（P＜0.01）.Slight heart dysfunction appeared in 13 cases of patients.After shunting,acute pancreatitis occurred in 3 cases, and 1 patient died of upper gastrointestinal hemorrhage on the 10 d after PSSs.Doppler ultrasonography for IVC and shunt vessels showed：the swollen liver and spleen lessened on 3d after endovascular procedures.The swollen liver lessened 2-7cm （mean 5.5cm）,swollen spleen lessened 3-8cm （mean 5.8cm）, and the time of ascites disappearance was 3-60d （mean 14d）.All the patients were followed up for 1 month to 15 years with an average of 3 years.Restenosis of the distal part of stent was found in 1 patient in 2 years after operation, hepatic vein occlusion occurred in 1 case in 1 year after treatment,hepatocellular carcinoma occurred in 1 patient in 3 years after stent implantation,and 1 patient died of C type hepatitis after 1 year,and 5 out of 6 cases of patients with infertility had babies after 1 year.All patients had no stent migration or occlusion of shunts and the symptoms of portal hypertension were obviously relieved.Conclusions Endovascular treatment guided by Doppler ultrasonography is a convenient,safe,and effective method for BCS.Portosystemic shunts are commended to patients with hepatic venous occlusions.The above mentioned methods provide a feasible and effective means for IVC stenosis and short segment occlusion with hepatic vein occlusion of BCS.
目的研究置管溶栓联合球囊扩张导管碎栓治疗下肢深静脉血栓形成（DVT）的疗效及安全性。 方法回顾性分析2011年9月至2015年1月本院收治的82例急性下肢DVT患者的临床资料。将患者分成两组：A组行单纯经导管直接溶栓（CDT）治疗，共32例，其中男10例、女22例，平均年龄（56±15）岁；B组行CDT联合机械碎栓（球囊扩张导管碎栓）治疗，共50例，其中男18例、女32例，平均年龄（57±17）岁。比较2组治疗前后静脉通畅率、静脉通畅度评分、健侧和患侧下肢周径差，比较2组尿激酶用量及溶栓导管留置时间，以出血并发症、肺栓塞的发生率评价治疗的安全性。 结果2组共82例患者完成溶栓及碎栓疗程，B组较A组溶栓时间更短，A组平均9（7，12）d；B组平均5（4，7）d，2组差异有统计学意义（P<0.01）；B组较A组尿激酶用量更少，A组平均7.250（6.355，8.255）×106 U，B组平均4.925（3.715，5.810）×106 U，2组差异有统计学意义（P<0.01）；B组治疗后的静脉通畅度评分显著优于A组，A组65.0%（40.5%，86.5%），B组为100%（90%，100%），差异有统计学意义（P<0.01）。治疗后2组出血并发症发生率差异无统计学意义（P=0.0976）。2组患者随访时间3～18个月，A组随访率50.0%，B组随访率58.0%，均未发生肺动脉栓塞。 结论在下腔静脉滤器保护下，CDT联合球囊扩张导管碎栓治疗急性下肢DVT较单纯CDT治疗，溶栓效果好、尿激酶用量少、不增加肺栓塞及出血发生率。