ABSTRACT
@#Objective To evaluate the early and mid-term safety of transcatheter aortic valve replacement via transfemoral (TF), transapical (TAp) and transsubclavian (TSc) approaches by meta-analysis. Methods We systematically searched the clinical comparative trials published from inception to June 2019 from PubMed, Web of Science, EMbase and The Cochrane Library, to evaluate the safety of transcatheter aortic valve replacement through TF, TAp or TSc approaches. The information of all-cause mortality at 30 days, 1 year, 2 years and the incidence of common complications at 30 days after operation (including pacemaker-dependent block, major vascular complications, severe bleeding events, acute renal injury and stroke) were exacted, and a meta-analysis was conducted by RevMan 5.3 software. Results This study included 11 literatures, with a total of 7 833 patients, among whom 5 348 patients were treated by TF TAVR, 1 796 patients by TAp TAVR and 689 patients by TSc TAVR. The results of the meta-analysis were as follows: (1) at 30 days after operation, the mortality of TF and TSc approaches were lower than that of the TAp approach (TF vs. TAp:OR=0.57, 95%CI 0.39-0.84, P=0.004; TSc vs. TAp: OR=4.12, 95%CI 1.93-8.79, P=0.000 3). There was no statistical difference between the TF and TSc approaches (TF vs. TSc: OR=0.98, 95%CI 0.38-2.51, P=0.97); at 1 year, there was no statistical difference in mortality among the three approaches (P>0.05); at 2 years, there was no statistical difference between TSc and TF or TAp approaches (TF vs. TSc: OR=1.21, 95%CI 0.95-1.54, P=0.13; TSc vs. TAp: OR=1.02, 95%CI 0.76-1.36, P=0.91). (2) The incidence of acute kidney injury after TF approach was lower than that of the TAp approach (OR=0.30, 95%CI 0.22-0.41, P<0.000 01). (3) There was no statistical difference in major vascular complications between TSc and TF or TAp approaches (TF vs. TSc: OR=0.75, 95%CI 0.38-1.49, P=0.41; TSc vs. TAp: OR=1.37, 95%CI 0.56-3.32, P=0.49). (4) There was no statistical difference in severe bleeding events between TF and TSc (OR=0.97, 95%CI 0.53-1.76, P=0.92). (5) There was no statistical difference in the incidence of postoperative stroke, pacemaker dependent block among the three approaches (P>0.05). Conclusion TAp and TSc approaches are safe and effective. They are not only an alternative to TF approach, but also the first choice in some patients with poor condition of iliofemoral artery.
ABSTRACT
Objective The purpose of this study was to investigate the preparation of a pulmonary self-expanding valved stent and the percutaneous implantation of a valved stent in the pulmonary valve position without cardiopulmonary bypass.Methods A bovine jugular valve conduit was trimmed to remove the extraneous materials to reduce profile,and then was sutured onto nitinol stents to form a pulmonary self-expanding valved stent.In vitro,it was tested by a pulsatile mock loop system.Through a 24F delivery system,the valved stents were deployed in the pulmonary valve position of 8 pigs,and then in vivo assessment with echocardiography and a postmortem examination were carried out.Results The pulmonary self-expanding valved stent has an inner diameter of (21.9 ± 1.6) mm,an outer diameter of (24.6 ± 1.5 ) mm,a length of (27.9 ± 4.3 )mm,and an effective orifice area of ( 1.8 ±0.2) cm2.7 of the 8 valved stents were exactly deployed in the native pulmonary valve position,1 valved stent failed.The transvalvular pressure gradient was (7.9 ± 3.3 ) mm Hg by catheter measurement,(9.3 ±4.1 ) mm Hg by Doppler echocardiography.The angiography showed no migration,no regurgitation and no paravalvular leak.The echocartiography showed all the new valves opened and closed well with 2 cases of mild regurgitation.Postmortem examination confirmed the valved stent straddled the pulmonary annuli without migration,the native valve was locked between the stent and arterial wall.Conclusion The acute study demonstrates that the self-expanding valved stent can be successfully implanted in the pulmonary position by a catheter delivery system and function well.Percutaneous pulmonary valve implantation without cardiopulmonary bypass is feasible and has a wide clinical perspective.
ABSTRACT
The statistical index of diagnosis coincidence was the base for the evaluation of diagnostic quality. By the problem analysis of diagnostic coincidence assessing, we were to establish standard criteria uniform and strict methods of evaluation; to enhance diagnosis coincidence rate, and to make full use of statistical index.