Expanded Polytetrafluoroethylene Combined with Human Acellular Dermis Matrix for the Nasal Reconstruction in Patients with Postoperative Deformities.

INTRODUCTION: Augmentation rhinoplasty is one of five aesthetic surgeries in the world. Expanded polytetrafluoroethylene (ePTFE) has been reported as a rational choice to augment the nasal dorsum and tip. However, its application for nasal tip augmentation has some debates. This study presented a technique using ePTFE grafts combined with human acellular dermis matrix (HADM) to reconstruct a deformed nose caused by previous rhinoplasties. METHODS: 50 female patients who came to the hospital from 08/2022 to 09/2022 for surgical revision of their nasal deformity. ePTFE was applied to reconstruct the nasal dorsum, tip, and columella strut. HADM grafts were utilized to reinforce the reconstructed framework. Patients were evaluated for at least 12 months for both aesthetic and functional results. RESULTS: Postoperatively, the nasal dorsal length increased from 38.9 ± 1.32 to 43.4 ± 1.22 mm; while, the projection of the nasal tip also raised from 19.8 ± 1.16 to 23.9 ± 1.05 mm. 38 patients (76%) reported that their breathing and smelling were improved compared to preoperatively. No cases had implant reactions, extrusion, or warping columella strut. Most of the patients (84%) were satisfied with the surgical outcomes. Three patients (6%) had redness at the nasal tip. The nasal tip of ten patients (20%) was hardened for 3 months postoperatively. There were 6% of patients who developed an infection and 2% of patients had asymmetric soft tissues of the tip 3 postoperative months. CONCLUSION: This technique brought satisfactory aesthetic and functional results to patients, with no extrusion or rejection observed 12 months postoperatively. Infection was a prominent complication that should be considered and strictly monitored. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Design and performance of double-layered artificial chordae.

Surgical repair with artificial chordae replacement has emerged as a standard treatment for mitral regurgitation. Expanded polytetrafluoroethylene (ePTFE) sutures are commonly employed as artificial chordae; however, they have certain limitations, such as potential long-term rupture and undesired material/tissue response. This study introduces a novel approach to artificial chordae design, termed the New Artificial Chordae (NAC), which incorporates a double-layered structure. The NAC comprises a multi-strand braided core composed of ultra-high molecular weight polyethylene (UHMWPE) fibers as the inner core, and an outer tube made of hydrophobic porous ePTFE. Compared to traditional ePTFE sutures, NAC exhibits increased flexibility, enhanced tensile strength, longer elongation and improved fatigue resistance. Moreover, NAC exhibits a more hydrophobic surface, which contributes to enhanced hemocompatibility. The study also includes in vivo investigations conducted on animal models to evaluate the biocompatibility and functional efficacy of the artificial chordae. These experiments demonstrate the enhanced durability and biocompatibility of the NAC, characterized by improved mechanical strength, minimal tissue response and reduced thrombus formation. These findings suggest the potential application of NAC as a prosthetic chordae replacement, offering promising prospects to address the limitations associated with current artificial chordae materials and providing novel ideas and approaches for the development of sustainable and biocompatible regenerative biomaterials.

Hybrid Approach: Combining Surgical Thrombectomy and AngioJet™ Aspirational Thrombectomy in Limb Graft Occlusion Post-FEVAR with Fenestrated Anaconda™ and in ePTFE Bypass Graft Occlusion.

Acute limb ischemia due to limb-graft occlusion (LGO) after fenestrated endovascular aneurysm repair (FEVAR) and acute bypass graft occlusion with an ePTFE graft pose critical challenges, necessitating prompt intervention to prevent limb loss. This paper discusses two cases of acute limb ischemia treated with a hybrid approach using the AngioJet™ Ultra Thrombectomy System as an adjunct to Fogarty thrombectomy. Case I involved a 69-year-old male post-FEVAR with contralateral iliac limb graft occlusion of the fenestrated Anaconda™, while Case II featured a 70-year-old male (ASA IV) post-bypass surgery (iliopopliteal arterial bypass with ePTFE Graft) with acute bypass graft occlusion. Both cases underwent successful recanalization using the AngioJet™ Ultra Thrombectomy System (ZelanteDVT™ 8F catheter, Solent™ Proxi 6F catheter) (Boston Scientific, Marlborough, MA, USA), combined with adjunctive techniques including Fogarty thrombectomy, balloon angioplasty, stenting, and local lysis. Immediate postoperative and follow-up assessments after 6 months revealed restored limb perfusion and improved clinical outcomes, with palpable pulses and improved ulcer healing. The aim of this treatment strategy is not only to alleviate limb ischemia but also to preserve future options in the event of graft failure. The use of the AngioJet™ Thrombectomy System in cases of LGO aims not only to clear the thrombus load but also to avoid the need for graft relining. In the case of acute arterial bypass graft occlusion in a patient with ASA IV, the goal of using the thrombectomy device is to preserve the native vessels for future procedures, such as long infragenual bypass, in addition to limb salvage. These cases demonstrate the efficacy of a hybrid surgical approach in managing acute limb ischemia following graft occlusion following FEVAR and bypass surgery. Long-term follow-up will further elucidate the durability of these interventions and their impact on limb salvage and overall patient outcomes. By combining mechanical thrombectomy with adjunctive techniques, such as balloon angioplasty and stenting, this hybrid approach offers a comprehensive solution to acute limb ischemia, addressing both the underlying occlusive pathology and ensuring optimal limb perfusion. Furthermore, the utilization of the AngioJet™ Ultra Thrombectomy System provides a minimally invasive yet effective method for thrombus removal, reducing procedural time and potential complications associated with open surgical techniques. As such, this approach represents a valuable addition to the armamentarium of treatments for acute limb ischemia, particularly in cases of graft occlusion following complex endovascular and bypass procedures.

Percutaneous intervention of a giant native coronary artery aneurysm using self-expanding stents.

In the absence of standardized management guidelines, coronary artery aneurysms (CAAs) present therapeutic challenges. Percutaneous coronary intervention (PCI) is rarely explored, especially in giant aneurysms with persistent angina, where surgery might be presumed as a preferred option. We describe the technical aspects and feasibility of PCI using Gore Viabahn expanded polytetrafluoroethylene (ePTFE)-covered nitinol self-expanding stents in a 66-year-old woman with a complex medical history and an enlarging, symptomatic right coronary artery aneurysm. The case was complicated by endoleak after the first stent, but intravascular ultrasound guidance enabled the precise deployment of additional stents, resulting in the successful exclusion of the aneurysm. This case demonstrates steps to successful CAA PCI with Gore Viabahn ePTFE-covered nitinol self-expanding stents and emphasizes that in unsuitable surgical candidates, PCI might be a potential alternative for symptomatic CAAs.

Expanded polytetrafluoroethylene mesh in chest-wall reconstruction: A 27-year experience.

OBJECTIVE: The study objective was to evaluate the success of expanded polytetrafluoroethylene mesh in chest-wall reconstruction. METHODS: We retrospectively reviewed patients who underwent expanded polytetrafluoroethylene (Gore-Tex) chest-wall reconstruction. The main outcome was a mesh-related event, defined as a mesh-related reoperation (eg, mesh infection requiring debridement with/without explant, tumor recurrence with explant) or structural dehiscence/mesh loosening with/without a hernia. Demographics and surgical outcomes were reported. RESULTS: A total of 246 reconstructions met inclusion (1994-2021). Fifty-five reconstructions (22.4%) had mesh-related events within a median of 1.08 years (interquartile range, 0.08-4.53) postoperatively; those without had a stable chest for a median of 3.9 years (interquartile range, 1.59-8.23, P < .001). Forty-one meshes (16.6%) became infected, requiring reoperation. Eighty-eight percent (36/41) were completely explanted; 8.3% (3/36) required additional mesh placement. Predictors of mesh-related events were prior chest-wall radiation (odds ratio, 9.73, CI, 3.47-30.10, P < .001), higher body mass index (odds ratio, 1.08, CI, 1.01-1.16, P = .019), and larger defects (odds ratio, 1.48, CI, 1.02-2.17, P = .042). The risk of mesh-related events with obesity was higher with prior chest-wall radiation. CONCLUSIONS: Most patients (78%) with an expanded polytetrafluoroethylene mesh had a stable reconstruction after a median of 4 years. Obesity, larger defects, and prior chest-wall radiation were associated with a higher risk of a mesh-related event mostly due to mesh infections. Seventeen percent of reconstructions had reoperation for mesh infection; 88% were completely explanted. Only 8% required replacement mesh, suggesting that experienced surgeons can safely manage them without replacement. Future studies should compare various meshes for high-risk patients to help guide the optimal mesh selection.

Custom-Made Implant Fabrication for Chin Augmentation Using Piled-Up Expanded Polytetrafluoroethylene Sheets: An Innovative Surgical Technique and Literature Review.

BACKGROUND: Alloplastic chin augmentation is the most common esthetic surgical treatment to reshape the chin. However, factory-made chin implants are typically standardized rather than custom-made and have potential to cause complications. Although the fabrication of custom-made implants by using computer-assisted planning and 3D-printing technology has become widespread, the process has several disadvantages, including long preoperative prosthesis preparation times, high costs, and unsuitability for patients with asymmetric chins or those who undergo combined mandibuloplasty before implant placement. The present study developed an innovative chin augmentation technique involving stacked expanded polytetrafluoroethylene (e-PTFE) sheets that is suitable for most patients and has minimal side effects. MATERIALS AND METHODS: A retrospective review of a single surgeon's experience was performed over a 2 year period for patients who underwent a procedure involving piled-up e-PTFE sheets for alloplastic chin augmentation. This study analyzed the outcomes, complications (temporary nerve numbness, wound infection, hematoma formation, and implant displacement), and patient satisfaction during follow-up. RESULTS: Between January 2018 and December 2020, 38 patients underwent the procedure involving piled-up e-PTFE sheets for alloplastic chin augmentation. Six patients (15.8%) experienced nerve-related temporary numbness, and one (2.6%) experienced wound infection. None had developed major complications such as implant displacement or wound infection at follow-up. Moreover, the patients demonstrated a high level of satisfaction with the surgical results. CONCLUSION: Piled-up e-PTFE sheets can be used to produce custom-fit porous polyethylene chin implants that result in minimal complications and a very high satisfaction rate. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Outcomes for expanded polytetrafluoroethylene strip in frontalis suspension surgery.

PURPOSE: This study evaluates surgical outcomes and complication rates of frontalis suspension with expanded polytetrafluoroethylene (ePTFE). METHODS: This retrospective cohort study reviewed all patients undergoing frontalis suspension surgery using ePTFE as the sling material from January 1 2012 to March 3 2020 by a single surgeon at a single academic center. Two different surgical techniques were evaluated in the placement of the sling material. Demographic, clinical, and operative data were extracted. Outcome data including postoperative lid height, reoperation, and complication rate were extracted for the cohort and compared between the two surgical techniques. Descriptive statistics were utilized. RESULTS: Sixty-four eyes from 49 unique patients were included in this study. Forty-three (67.2%) patients had isolated congenital blepharoptosis; 14 (21.9%) had blepharophimosis, ptosis, and epicanthus inversus syndrome (BPES); and 2 (3.1%) had cranial nerve III palsy. Fifty-one (79.7%) patients had no prior blepharoptosis surgery. Lid crease incision and stab incision techniques were utilized for 24 (37.5%) and 40 (62.5%) eyes, respectively. Overall, 21 (32.8%) eyes required reoperation with ePTFE to achieve appropriate eyelid height or contour. Only one patient experienced implant infection, requiring removal of ePTFE sling after a second reoperation. There were no cases of implant exposure or granuloma formation noted during the study period. CONCLUSION: An ePTFE strip soaked in cefazolin prior to utilization in surgery is a viable material for frontalis suspension surgery, with a lower infectious or inflammatory complication rate than previously reported. However, reoperation rate was still relatively high.

Leveraging the Dielectric Barrier Discharge Plasma Process to Create Regenerative Biocidal ePTFE Membranes.

The utilization of dielectric barrier discharge (DBD) plasma treatment for modifying substrate surfaces constitutes an easy and simple approach with a potential for diverse applications. This technique was used to modify the surface of a commercial porous expanded poly(tetrafluoroethylene) (ePTFE) film with either dimethylaminoethyl methacrylate (DMAEMA) or (trimethylamino)ethyl methacrylate chloride (TMAEMA) monomers, aiming to obtain antibacterial ePTFE. Physicochemical analyses of the membranes revealed that DBD successfully enhanced the surface energy and surface charge of the membranes while maintaining high porosity (>75%) and large pore size (>1.0 µm). Evaluation of the bacteria killing-releasing (K-R) function revealed that both DMAEMA and TMAEMA endowed ePTFE with the ability to kill Escherichia coli bacteria. However, only TMAEMA-grafted ePTFE allowed for the release of dead bacteria from the surface upon washing with sodium hexametaphosphate (SHMP) saline solution, owing to its cationic charge derived from the quaternary amine. Washing with SHMP disturbed the electrostatic force between the polymer brushes and dead bacteria, which caused the release of the dead bacteria. Lastly, dead-end bacteria filtration showed that the TMAEMA-grafted ePTFE was able to kill 99.78% of the bacteria, while approximately 61.55% of bacteria were killed upon contact. The present findings support the feasibility of using DBD plasma treatment for designing surfaces that target bacteria and aid in the containment of disease-causing pathogens.

Biological mechanisms of infection resistance in tissue engineered blood vessels compared to synthetic expanded polytetrafluoroethylene grafts.

Objective: Synthetic expanded polytetrafluoroethylene (ePTFE) grafts are known to be susceptible to bacterial infection. Results from preclinical and clinical studies of bioengineered human acellular vessels (HAVs) have shown relatively low rates of infection. This study evaluates the interactions of human neutrophils and bacteria with ePTFE and HAV vascular conduits to determine whether there is a correlation between neutrophil-conduit interactions and observed differences of their infectivity in vivo. Methods: A phase III comparative clinical study between investigational HAVs (n = 177) and commercial ePTFE grafts (n = 178) used for hemodialysis access (ClinicalTrials.gov Identifier: NCT02644941) was evaluated for conduit infection rates followed by histological analyses of HAV and ePTFE tissue explants. The clinical histopathology of HAV and ePTFE conduits reported to be infected was compared with immunohistochemistry of explanted materials from a preclinical model of bacterial contamination. Mechanistic in vitro studies were then conducted using isolated human neutrophils seeded directly onto HAV and ePTFE materials to analyze neutrophil viability, morphology, and function. Results: Clinical trial results showed that the HAV had a significantly lower (0.93%; P = .0413) infection rate than that of ePTFE (4.54%). Histological analysis of sections from infected grafts explanted approximately 1 year after implantation revealed gram-positive bacteria near cannulation sites. Immunohistochemistry of HAV and ePTFE implanted in a well-controlled rodent infection model suggested that the ePTFE matrix permitted bacterial infiltration and colonization but may be inaccessible to neutrophils. In the same model, the HAV showed host recellularization and lacked detectable bacteria at the 2-week explant. In vitro results demonstrated that the viability of human neutrophils decreased significantly upon exposure to ePTFE, which was associated with neutrophil elastase release in the absence of bacteria. In contrast, neutrophils exposed to the HAV material retained high viability and native morphology. Cocultures of neutrophils and Staphylococcus aureus on the conduit materials demonstrated that neutrophils were more effective at ensnaring and degrading bacteria on the HAV than on ePTFE. Conclusions: The HAV material seems to demonstrate a resistance to bacterial infection. This infection resistance is likely due to the HAV's native-like material composition, which may be more biocompatible with host neutrophils than synthetic vascular graft material.

The Development of a Permanent Implantable Spacer with the Function of Size Adjustability for Customized Treatment of Regurgitant Heart Valve Disease.

The Pivot Mandu is an innovative device featuring a leak-tight adjustable 3D balloon spacer, incorporating inner mesh support, an outer e-PTFE layer, and a compliant balloon in the middle layer with a specialized detachable system. To assess its feasibility, proof of concept was rigorously evaluated through bench testing and survival porcine animal experiments. The results demonstrated successful remote inflation of the balloon system, with the balloon spacer exhibiting sustained patent and functional integrity over an extended observation period of up to 6 months. A noteworthy feature of the newly designed 3D balloon spacer is its capability for easy size adjustment during procedures, enhancing its adaptability and practicality in clinical settings. This three-layered 3D balloon spacer, with its established long-term patency, exhibits highly encouraging outcomes that hold promise in overcoming the current limitations of spacer devices for heart valve diseases. Given the compelling results from preclinical investigations, the translation of the Pivot Mandu into human trials is strongly warranted.

Anti-thrombotic poly(AAm-co-NaAMPS)-xanthan hydrogel-expanded polytetrafluoroethylene (ePTFE) vascular grafts with enhanced endothelialization and hemocompatibility properties.

Cardiovascular diseases (CVDs) are the leading cause of death among all non-communicable diseases globally. Although expanded polytetrafluoroethylene (ePTFE) has been widely used for larger-diameter vascular graft transplantation, the persistent thrombus formation and intimal hyperplasia of small-diameter vascular grafts (SDVGs) made of ePTFE to treat severe CVDs remain the biggest challenges due to lack of biocompatibility and endothelium. In this study, bi-layered poly(acrylamide-co-2-Acrylamido-2-methyl-1-propanesulfonic acid sodium)-xanthan hydrogel-ePTFE (poly(AAm-co-NaAMPS)-xanthan hydrogel-ePTFE) vascular grafts capable of promoting endothelialization and prohibiting thrombosis were synthesized and fabricated. While the external ePTFE layer of the vascular grafts provided the mechanical stability, the inner hydrogel layer offered much-needed cytocompatibility, hemocompatibility, and endothelialization functions. The interface morphology between the inner hydrogel layer and the outer ePTFE layer was observed by scanning electron microscope (SEM), which revealed that the hydrogel was well attached to the porous ePTFE through mechanical interlocking. Among all the hydrogel compositions tested with cell culture using human umbilical vein endothelial cells (HUVECs), the hydrogel with the molar ratio of 40:60 (NaAMPS/AAm) composition (i.e., Hydrogel 40:60) exhibited the best endothelialization function, as it produced the largest endothelialization area that was three times more than of that of plain ePTFE on day 14, maintained the highest average cell viability, and had the best cell morphology. Hydrogel 40:60 also showed excellent hemocompatibility, prolonged activated partial thromboplastin time (aPTT), and good mechanical properties. Overall, bi-layered poly(AAm-co-NaAMPS)-xanthan hydrogel-ePTFE vascular grafts with the Hydrogel 40:60 composition could potentially solve the critical challenge of thrombus formation in vascular graft transplantation applications.

Small diameter expanded polytetrafluoroethylene vascular graft with differentiated inner and outer biomacromolecules for collaborative endothelialization, anti-thrombogenicity and anti-inflammation.

Without differentiated inner and outer biological function, expanded polytetrafluoroethylene (ePTFE) small-diameter (<6 mm) artificial blood vessels would fail in vivo due to foreign body rejection, thrombosis, and hyperplasia. In order to synergistically promote endothelialization, anti-thrombogenicity, and anti-inflammatory function, we modified the inner and outer surface of ePTFE, respectively, by grafting functional biomolecules, such as heparin and epigallocatechin gallate (EGCG), into the inner surface and polyethyleneimine and rapamycin into the outer surface via layer-by-layer self-assembly. Fourier-transform infrared spectroscopy showed the successful incorporation of EGCG, heparin, and rapamycin. The collaborative release profile of heparin and rapamycin lasted for 42 days, respectively. The inner surface promoted human umbilical vein endothelial cells (HUVECs) adhesion and growth and that the outer surface inhibited smooth muscle cells growth and proliferation. The modified ePTFE effectively regulated the differentiation behavior of RAW264.7, inhibited the expression of proinflammatory mediator TNF-α, and up-regulated the expression of anti-inflammatory genes Arg1 and Tgfb-1. The ex vivo circulation results indicated that the occlusions and total thrombus weight of modified ePTFE was much lower than that of the thrombus formed on the ePTFE, presenting good anti-thrombogenic properties. Hence, the straightforward yet efficient synergistic surface functionalization approach presented a potential resolution for the prospective clinical application of small-diameter ePTFE blood vessel grafts.

The clinical effectiveness of staple line reinforcement with different matrix used in surgery.

Staplers are widely used in clinics; however, complications such as bleeding and leakage remain a challenge for surgeons. To tackle this issue, buttress materials are recommended to reinforce the staple line. This Review provides a systematic summary of the characteristics and applications of the buttress materials. First, the physical and chemical properties of synthetic polymer materials and extracellular matrix used for the buttress materials are introduced, as well as their pros and cons in clinical applications. Second, we review the clinical effects of reinforcement mesh in pneumonectomy, sleeve gastrectomy, pancreatectomy, and colorectal resection. Based on the analysis of numerous research data, we believe that buttress materials play a crucial role in increasing staple line strength and reducing the probability of complications, such as bleeding and leakage. However, considering the requirements of bioactivity, degradability, and biosafety, non-crosslinked small intestinal submucosa (SIS) matrix material is the preferred candidate. It has high research and application value, but further studies are required to confirm this. The aim of this Review is to provide comprehensive guidance on the selection of materials for staple line reinforcement.

Polyetheretherketone (PEEK) as a Potential Material for the Repair of Maxillofacial Defect Compared with E-poly(tetrafluoroethylene) (e-PTFE) and Silicone.

Silicone and e-poly(tetrafluoroethylene) (e-PTFE) are the most commonly used artificial materials for repairing maxillofacial bone defects caused by facial trauma and tumors. However, their use is limited by poor histocompatibility, unsatisfactory support, and high infection rates. Polyetheretherketone (PEEK) has excellent mechanical strength and biocompatibility, but its application to the repair of maxillofacial bone defects lacks a theoretical basis. The microstructure and mechanical properties of e-PTFE, silicone, and PEEK were evaluated by electron microscopy, BOSE machine, and Fourier transformed infrared spectroscopy. Mouse fibroblast L929 cells were incubated on the surface of the three materials to assess cytotoxicity and adhesion. The three materials were implanted onto the left femoral surface of 90 male mice, and samples of the implants and surrounding soft tissues were evaluated histologically at 1, 2, 4, 8, and 12 weeks post-surgery. PEEK had a much higher Young's modulus than either e-PTFE or silicone (p < 0.05 each), and maintained high stiffness without degradation long after implantation. Both PEEK and e-PTFE facilitated L929 cell adhesion, with PEEK having lower cytotoxicity than e-PTFE and silicone (p < 0.05 each). All three materials similarly hindered the motor function of mice 12 weeks after implantation (p > 0.05 each). Connective tissue ingrowth was observed in PEEK and e-PTFE, whereas a fibrotic peri-prosthetic capsule was observed on the surface of silicone. The postoperative infection rate was significantly lower for both PEEK and silicone than for e-PTFE (p < 0.05 each). PEEK shows excellent biocompatibility and mechanical stability, suggesting that it can be effective as a novel implant to repair maxillofacial bone defects.

A review of the development of interventional devices for mitral valve repair with the implantation of artificial chords.

Mitral regurgitation (MR) was the most common heart valve disease. Surgical repair with artificial chordal replacement had become one of the standard treatments for mitral regurgitation. Expanded polytetrafluoroethylene (ePTFE) was currently the most commonly used artificial chordae material due to its unique physicochemical and biocompatible properties. Interventional artificial chordal implantation techniques had emerged as an alternative treatment option for physicians and patients in treating mitral regurgitation. Using either a transapical or a transcatheter approach with interventional devices, a chordal replacement could be performed transcatheter in the beating heart without cardiopulmonary bypass, and the acute effect on the resolution of mitral regurgitation could be monitored in real-time by transesophageal echo imaging during the procedure. Despite the in vitro durability of the expanded polytetrafluoroethylene material, artificial chordal rupture occasionally occurred. In this article, we reviewed the development and therapeutic results of interventional devices for chordal implantation and discuss the possible clinical factors responsible for the rupture of the artificial chordal material.

Clinical investigation of the GORE drug-coated PTA balloon catheter for CE mark approval.

OBJECTIVES: Paclitaxel-coated balloon angioplasty has been established as the first-line therapy for femoropopliteal artery disease. The primary objectives of the study were to evaluate the performance and the safety of the GORE-DCB Catheter in the treatment of atherosclerotic femoropopliteal lesions in patients with peripheral artery disease for CE-Mark approval. METHODS: Prospective, single-arm, multicenter study with 24 months follow-up. The GORE-DCB Catheter consists of a drug-coated nylon (inner layer)/ePTFE (outer layer) composite balloon. The ePTFE layer is coated with paclitaxel (concentration: 3.5 µg/mm2) and the excipient stearic acid/tromethamine (tris). The primary endpoints were 6-month late lumen loss (LLL) and 30-day of freedom from Major Adverse Events (MAE). RESULTS: Fifty-two subjects were enrolled, 69% men, median age 69 (49-83) years. Acute device success was 100%, the 30-day MAE rate was zero. Study primary endpoint of LLL (-0.17 mm) showed significant superiority compared to the performance goal of uncoated PTA balloon catheters from literature. At 1 and 2 years, primary patency rates were 81.8% and 68.7%, respectively, and freedom from clinically driven target lesion revascularization rates was 87.9% and 83.4%, respectively. CONCLUSION: The study demonstrates that the treatment of lesions in femoropopliteal arteries with the GORE-DCB Catheter is safe and effective.

Anatomical and biometric study of the mitral valve apparatus: application in valve repair surgery.

OBJECTIVE: Most mitral valve repair techniques provide excellent surgical results by removing regurgitation, but all of these techniques simultaneously reduce posterior valve mobility. A comprehensive biometric study of the mitral valve apparatus will provide landmarks that would help improve this posterior valve mobility. MATERIALS AND METHODS: Thirty one (31) human hearts have been studied, from 14 women and 17 men. The characteristics of the studied sample were analyzed descriptively. The difference in means of the variables between women and men were tested using a Student t test. Correlations between the different measures were determined by simple regression analysis. Mean values are shown with ± 1 standard deviation and the limit of significance was set at 0.05. RESULTS: The mean weight of the hearts was 275.3 ± 2.4 g. The anteroposterior diameter of the mitral annulus was 29.3 ± 1.22 mm, the intertrigonal distance was 25.2 ± 3.50 mm and the anterior leaflet to posterior leaflet ratio was 1.9 ± 0.10, the length of the chordae A2 = 19.4 ± 1.15 mm and P2 = 14.5 ± 0.85 mm. The length of the anterior papillary muscle averaged 30.9 ± 7.20 mm and that of the posterior one 30.0 ± 8.75 mm. The comparison of the different values measured between women and men showed no statistically significant difference (p > 0.05). There was no correlation between these different measured values (p > 0.05). CONCLUSION: A perfect knowledge of anatomy and biometry is therefore essential to offer alternative techniques that reproduce the real anatomy and physiology with a complete reconstruction of the mitral valve.

Percutaneous reduction of septal-to-lateral mitral annular distance to increase mitral leaflet coaptation length: Preclinical study results.

Objectives: Percutaneous indirect annuloplasty has emerged as a treatment strategy for functional/ischemic mitral regurgitation. This study sought to evaluate the feasibility of percutaneous indirect annuloplasty technique using a new device. Methods: The device has 3 components: the "saddle" inserted into the great cardiac vein, the "plug" positioned in the left ventricular outflow tract, and the "bridge," a transatrial suture connecting the 2 holding elements. The aim was to shorten the septal-to-lateral distance of the mitral annulus by pulling on the saddle element. The procedure was performed through venous access in healthy adult sheep. A dedicated catheter holding a needle was used to deploy the saddle into the great cardiac vein and pierce its wall toward the left atrium to deploy the expanded polytetrafluoroethylene suture that is part of the bridge. A catheter for transseptal puncture was inserted for crossing the interatrial septum and piercing the aortic-mitral curtain, thereby allowing the plug to be deployed. The plug was held in place by the second part of the expanded polytetrafluoroethylene bridge. The 2 parts of the bridge were then joined to reduce the septal-to-lateral mitral annular distance. The septal-to-lateral distance and the coaptation length at P2 level were measured before and after the procedure using echocardiography. Results: Overall, 10 animals were treated, 7 successfully. The mean procedure duration was 110 ± 81 minutes. Septal-to-lateral distance decreased from 3.8 mm to 2.6 mm (30%), and maximum increase of mitral leaflet coaptation was 4 mm. Conclusions: This new approach seems promising for percutaneous treatment of functional mitral regurgitation.

1-Year Patency of Biorestorative Polymeric Coronary Artery Bypass Grafts in an Ovine Model.

Many attempts have been made to inhibit or counteract saphenous vein graft (SVG) failure modes; however, only external support for SVGs has gained momentum in clinical utility. This study revealed the feasibility of implantation, and showed good patency out to 12 months of the novel biorestorative graft, in a challenging ovine coronary artery bypass graft model. This finding could trigger the first-in-man trial of using the novel material instead of SVG. We believe that, eventually, this novel biorestorative bypass graft can be one of the options for coronary artery bypass graft patients who have difficulty harvesting SVG.

Trans-Cervical Endovascular Management of Saccular Aneurysm of the Extracranial Internal Carotid Artery Using a Self-Expanding Nitinol Base ePTFE Covered Stent.

Saccular aneurysm of the extracranial internal carotid artery is rare. We present a 56-year-old lady presented with a progressively enlarging pulsatile swelling over the right neck, and the right internal carotid artery aneurysm was successfully treated with trans-carotid endovascular stenting of right common to right carotid artery using a self-expanding nitinol base ePTFE covered stent (COVERA Plus™ stent, Bard, Tempe, USA). The external carotid artery was prophylactically embolised to prevent back bleeding. New generation covered stents have consistently improved flexibility and conformability, and this is to our knowledge the first reported case in the world's literature of using this type of self-expanding nitinol base ePTFE covered stent in endovascular stenting of carotid artery aneurysms, with excellent short-term results.