Drug-coated balloon for the treatment of small vessel disease: 9 months of angiographic results and 12 months of clinical outcomes of the PEPCAD China SVD study.

BACKGROUND: Whether the drug-coated balloons (DCBs)-alone strategy was superior to plain old balloon angioplasty (POBA) in treating SVD remains unknown. AIMS: We aimed to evaluate the efficacy and safety of DCBs for the treatment of coronary de novo small vessel disease (SVD) and provide further evidence for extending the clinical indications of DCBs. (ChiCTR1800014966). METHODS: Eligible patients were randomized at a 2:1 ratio to receive DCB treatment or POBA in this prospective, multicenter clinical trial. The reference vessel diameter of lesions was visually assessed to be 2.0 to 2.75 mm. The primary endpoint of the study was angiographic in-segment late luminal loss (LLL) at the 9-month follow-up to demonstrate the superiority of DCB treatment to POBA in SVD. The composite clinical endpoints included clinically driven target lesion revascularization (CD-TLR), target lesion failure (TLF), major adverse cardiac events (MACEs), and thrombosis at the 12-month follow-up. RESULTS: A total of 270 patients were enrolled (181 for DCB, 89 for POBA) at 18 centers in China. The primary endpoint of 9-month in-segment LLL in the intention-to-treat population was 0.10 ± 0.33 mm with DCB and 0.25 ± 0.38 mm with POBA (p = 0.0027). This difference indicated significant superiority of DCB treatment (95% CI: -0.22, -0.04, psuperiority = 0.0068). The rates of the clinical endpoints-CD-TLR, TLF, and MACEs-were comparable between groups. No thrombosis events were reported. CONCLUSIONS: DCB treatment of de novo SVD was superior to POBA with lower 9-month in-segment LLL. The rates of clinical events were comparable between the two devices.

Drug-eluting balloons for de novo coronary artery disease: a meta-analysis of angiographic and clinical data.

OBJECTIVES: To evaluate the effectiveness of drug-eluting balloons (DEBs) in the treatment of de novo coronary artery disease by performing a meta-analysis of randomized controlled trials (RCTs). BACKGROUNDS: Current evidence regarding the success of DEBs is insufficient to formulate formal recommendations. METHODS: Seven RCTs were ultimately included. The primary angiographic endpoint was in-segment diameter stenosis, compared by measuring weighted mean difference (WMD). The primary clinical endpoint was incidence of major adverse cardiovascular events (MACEs) during a 1-year follow-up, compared by measuring pooled risk ratio (RR). RESULTS: For de novo native coronary lesions intervention, DEB plus bare metal stent (BMS) was not superior to BMS alone in both primary angiographic and clinical endpoints (in-segment diameter stenosis: WMD, -2.59% [95% confidence interval (CI): -9.13% to 3.94%]; MACEs: RR, 0.83 [95%CI: 0.48-1.46]), and DEB with/without BMS was associated with worse outcomes when compared with DES alone (in-segment diameter stenosis: WMD, 10.64% [95%CI: 2.41-18.87%]; MACEs: RR, 1.54 [95%CI: 0.91-2.61]). Subgroup analysis showed that DEB plus BMS significantly increased the risk of MACEs for simple de novo coronary lesions intervention when compared with DES alone (RR, 1.87 [95%CI: 1.33-2.63]). CONCLUSIONS: Current data does not support the use of DEBs for de novo coronary lesions, especially for simple coronary lesions.

Case report: Transcatheter pulmonary valve-in-valve implantation in a deteriorated self-expandable valve caused by infective endocarditis.

Background: Infective endocarditis is a complication with high mortality in patients with congenital heart disease, particularly for those with bioprosthetic valve. Case summary: We report a case of a 54-year-old female with a history of tetralogy of Fallot who had been surgically repaired using a transannular patch due to severe pulmonary insufficiency with right heart enlargement and presented with worsening dyspnea. She had received transcatheter pulmonary valve implantation (TPVI) 5 years ago. Unfortunately, bioprosthesis-associated infective endocarditis occurred due to dental caries. Given persistent antibiotic medication, she became clinically stable with prosthesis functional recovery. However, dysfunctional bioprosthesis was still detected 3 years later, which was successfully treated by valve-in-valve TPVI with the help of modified buddy wire technique. At a 12-month follow-up after valve-in-valve TPVI, she was completely recovered with improved symptoms of heart failure. Conclusion: This is the first report of valve-in-valve TPVI of a self-expandable valve in a degenerated self-expandable valve. The case highlights increased surveillance for infective endocarditis of transcatheter pulmonary valve should be emphasized. Subsequent valve-in-valve TPVI is an effective treatment for valve failure in defined conditions improving the hemodynamics.

Mechanical properties and biocompatibility of melt processed, self-reinforced ultrahigh molecular weight polyethylene.

The low efficiency of fabrication of ultrahigh molecular weight polyethylene (UHMWPE)-based artificial knee joint implants is a bottleneck problem because of its extremely high melt viscosity. We prepared melt processable UHMWPE (MP-UHMWPE) by addition of 9.8 wt% ultralow molecular weight polyethylene (ULMWPE) as a flow accelerator. More importantly, an intense shear flow was applied during injection molding of MP-UHMWPE, which on one hand, promoted the self-diffusion of UHMWPE chains, thus effectively reducing the structural defects; on the other hand, increased the overall crystallinity and induced the formation of self-reinforcing superstructure, i.e., interlocked shish-kebabs and oriented lamellae. Aside from the good biocompatibility, and the superior fatigue and wear resistance to the compression-molded UHMWPE, the injection-molded MP-UHMWPE exhibits a noteworthy enhancement in tensile properties and impact strength, where the yield strength increases to 46.3 ± 4.4 MPa with an increment of 128.0%, the ultimate tensile strength and Young's modulus rise remarkably up to 65.5 ± 5.0 MPa and 1248.7 ± 45.3 MPa, respectively, and the impact strength reaches 90.6 kJ/m(2). These results suggested such melt processed and self-reinforced UHMWPE parts hold a great application promise for use of knee joint implants, particularly for younger and more active patients. Our work sets up a new method to fabricate high-performance UHMWPE implants by tailoring the superstructure during thermoplastic processing.