Long-Term Outcomes After Melody Transcatheter Pulmonary Valve Replacement in the US Investigational Device Exemption Trial

Background: The Melody valve was developed to extend the useful life of previously implanted right ventricular outflow tract (RVOT) conduits or bioprosthetic pulmonary valves, while preserving RV function and reducing the lifetime burden of surgery for patients with complex congenital heart disease. Methods: Enrollment for the US Investigational Device Exemption study of the Melody valve began in 2007. Extended follow-up was completed in 2020. The primary outcome was freedom from transcatheter pulmonary valve (TPV) dysfunction (freedom from reoperation, reintervention, moderate or severe pulmonary regurgitation, and/or mean RVOT gradient >40 mm Hg). Secondary end points included stent fracture, catheter reintervention, surgical conduit replacement, and death. Results: One hundred seventy-one subjects with RVOT conduit or bioprosthetic pulmonary valve dysfunction were enrolled. One hundred fifty underwent Melody TPV replacement. Median age was 19 years (Q1–Q3: 15–26). Median discharge mean RVOT Doppler gradient was 17 mm Hg (Q1–Q3: 12–22). The 149 patients implanted >24 hours were followed for a median of 8.4 years (Q1–Q3: 5.4–10.1). At 10 years, estimated freedom from mortality was 90%, from reoperation 79%, and from any reintervention 60%. Ten-year freedom from TPV dysfunction was 53% and was significantly shorter in children than in adults. Estimated freedom from TPV-related endocarditis was 81% at 10 years (95% CI, 69%–89%), with an annualized rate of 2.0% per patient-year. Conclusions: Ten-year outcomes from the Melody Investigational Device Exemption trial affirm the benefits of Melody TPV replacement in the lifetime management of patients with RVOT conduits and bioprosthetic pulmonary valves by providing sustained symptomatic and hemodynamic improvement in the majority of patients. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT00740870.

397 Long-term follow-up after balloon expandable covered stents implantation for management of TAVI-related vascular access complications

Aims Despite increasing experience and device innovation with transcatheter aortic valve implantation (TAVI), vascular complications are still a major problem and endovascular management is generally the first option. When stent implantation is required, self expandable (SE) stents are generally preferred over balloon expandable (BE) stents as they are more elastic and less compressible. However, BE stents support higher radial outward force, adhere to the vase lumen with greater precision and are less expensive. As no large registry reported data about stents BE alone in this setting, we report our experience with BE stents implantation to manage a vascular complication after TAVI. We believe that our work could be useful and possibly serves as a starting point for future research. Methods and results We retrospectively collected baseline, procedural and follow-up data about 78 patients who were implanted with a BE stent to manage a vascular complication after TAVI. At a median clinical follow-up of 410 days (IQR: 66–1016 days), no percutaneous or surgical interventions were reported after discharge. No cases of symptomatic leg-ischaemia were reported and only one patient was symptomatic for claudication. Doppler follow-up (available for 25 patients; 32%) showed no cases of stent fracture or displacement. Conclusions Our experience showed good acute and long-term results of BE covered stent implantation to manage a vascular complication after TAVI. It is possible that a greater radial outward force is a good choice in terms of hemostasis without necessarily being associated with stent deformation/fracture resulting in restenosis or further interventions. While present data may not be generalized, they may be useful to critically re-evaluate (and eventually reduce) the need of SE stents when treating femoral arteries bleedings.

Peri-Contrast Staining as a Marker of Stent Failure: Restenosis, Thrombosis, and Fracture

The introduction of stents has led to significant improvement in the management of coronary artery disease. In-stent thrombosis, target lesion revascularization, and stent fracture (SF) have been identified as causes of in-stent restenosis. Peri-contrast staining (PSS) has been associated with in-stent restenosis, stent thrombosis, stent fracture, and the development of coronary aneurysm. As the frequency of patients with first generation sirolimus-eluting coronary stents becomes infrequent; PSS may go unrecognized. Herein, we present a patient with a decade of longitudinal follow-up, who developed PSS identified on coronary angiogram with recurrent stent failure.

A case report of successful stent implantation through a fractured stent-strut in a superficial femoral artery based on bench testing simulation

Background Stent implantation through the stent-strut of a previously implanted self-expandable stent in the superficial femoral artery (SFA) is not usually performed because the additional stent cannot dilate sufficiently. The key point to achieve sufficient expansion of an additional stent is to break the stent-strut of the previously implanted stent. However, there is no report of how to break the stent-strut. Case summary A 72-year-old man was admitted to our hospital with acute rest pain and coldness of his left leg; he was diagnosed with acute limb ischaemia. The angiogram demonstrated a fractured stent as well as stent occlusion in the left distal SFA. The guidewire could pass only through the stent-strut because of stent fracture. Fortunately, balloon angioplasty through the stent-strut and thrombolysis achieved successful revascularization. Thereafter, an additional stent was implanted in an attempt to manage the fractured and deformed stent. To obtain sufficient expansion of the additional stent, an experimental study to examine the balloon diameter and pressure to break the stent-strut was performed. Based on the results of the experiment, the stent-strut was successfully broken, and the additional stent was expanded through the stent-strut on the second intervention. Discussion If an additional self-expandable stent is deployed through the stent-strut directly, it would not be sufficiently dilated. The key point in such a case is to break the stent-strut of the previously implanted stent by balloon inflation before deployment of the additional stent. The experimental study examined the balloon diameter and pressure that can break the stent-strut. This information would be useful when we implant an additional stent through a stent-strut.

Multicenter Experience With Large Diameter Balloon-Expandable Stent-Grafts for the Treatment of Infrarenal Penetrating Aortic Ulcers

Purpose To describe the use of large-diameter balloon-expandable stent-grafts (BeGraft aortic stent-graft, Bentley InnoMed GmbH, Hechingen, Germany) in the treatment of infrarenal penetrating aortic ulcer (iPAU). Materials and Methods Retrospective analysis of patients undergoing endovascular treatment with the BeGraft aortic stent-graft in 8 European centers from January 2017 to October 2020. Demographics, perioperative data, and midterm outcomes were collected. Endpoints of the study were technical feasibility, early mortality, and morbidity. Results A total of 40 patients were included. The mean age was 73.9±7.05 years and 63.2% were male. Indications for treatment included size and morphology (65%), presence of symptoms (29.5%), and contained ruptures (5.5%). Urgent treatment was performed in 5% of cases. Technical success was 97.5%. Median operation time was 58 minutes (19–170 minutes), with 27.5% of patients having additional procedures during the main intervention (1 additional repair with a C-TAG (W.L. Gore & Associates, Inc, Flagstaff, AZ, USA) thoracic endoprosthesis, 5 covered endovascular reconstruction of aortic bifurcation procedures, 3 extensions with proximal cuffs, and 2 percutaneous angioplasties of the common iliac arteries). Percutaneous femoral access was used in 72.5%, while groin cut-down was performed in 27.5%. Repair was successful with only 1 stent in 45% of cases, while 37.5% required 2 stents and nearly 17.5% required 3/4 stent-grafts. The 30-day mortality was 0%, with a 2.5% reintervention rate (1 patient required evacuation of an intra-abdominal hematoma). Median follow-up was 13.9 months (2–39 months), during which no vascular-related reinterventions or deaths were reported. In 4 patients, a type II endoleak was observed. No cases of graft migration, thrombosis, or stent-fracture were observed. Conclusions The treatment of iPAU with the BeGraft aortic stent-graft in a selective patient group is feasible with low rate of perioperative morbidity and mortality. Balloon-expandable stent-grafts offer the option to repair iPAUs with a shorter coverage of the aorta using low-profile sheath, that enables treatment in the presence of calcified access vessels and small diameter aortic bifurcations.

Evaluation of the Feasibility and Effectiveness of Placement of Fully Covered Self-Expandable Metallic Stents via Various Insertion Routes for Benign Biliary Strictures

Background and aims: The goals of the management of benign biliary stricture (BBS) are to relieve symptoms and resolve short-/long-term stricture. We performed fully covered self-expandable metallic stent (hereafter, FCSEMS) placement for BBS using various methods and investigated the treatment outcomes and adverse events (AEs). Methods: We retrospectively studied patients who underwent FCSEMS placement for refractory BBS through various approaches between January 2017 and February 2020. FCSEMS were placed for 6 months, and an additional FCSEMS was placed if the stricture had not improved. Technical success rate, stricture resolution rate, and AE were measured. Results: A total of 26 patients with BBSs that were difficult to manage with plastic stents were included. The mean overall follow-up period was 43.3 ± 30.7 months. The cause of stricture was postoperative (46%), inflammatory (31%), and chronic pancreatitis (23%). There were four insertion methods: endoscopic with duodenoscopy, with enteroscopy, EUS-guided transmural, and percutaneous transhepatic. The technical success rate was 100%, without any AE. Stricture resolution was obtained in 19 (83%) of 23 cases, except for three cases of death due to other causes. Stent migration and cholangitis occurred in 23% and 6.3%, respectively. Stent fracture occurred in two cases in which FCSEMSs were placed for more than 6 months (7.2 and 10.3 months). Conclusion: FCSEMS placement for refractory BBS via various insertion routes was feasible and effective. FCSEMSs should be exchanged every 6 months until stricture resolution because of stent durability. Further prospective study for confirmation is required, particularly regarding EUS-guided FCSEMS placement.

Outcomes of Advanta V12 Covered Stents After Fenestrated Endovascular Aneurysm Repair

Purpose: Fenestrated endovascular aneurysm repair (FEVAR) is a well-established endovascular treatment option for pararenal abdominal aortic aneurysms in which balloon-expandable covered stents (BECS) are used to bridge the fenestration to the target vessels. This study presents midterm clinical outcomes and patency rates of the Advanta V12 BECS used as a bridging stent. Methods: All patients treated with FEVAR with at least 1 Advanta V12 BECS were included from 2 large-volume vascular centers between January 2012 and December 2015. Primary endpoints were freedom from all-cause reintervention, and freedom from BECS-associated complications and reintervention. BECS-associated complications included significant stenosis, occlusion, type 3 endoleak, or stent fracture. Secondary endpoints included all-cause mortality in-hospital and during follow-up. Results: This retrospective study included 194 FEVAR patients with a mean age of 72.2±8.0 years. A total of 457 visceral arteries were stented with an Advanta V12 BECS. Median (interquartile range) follow-up time was 24.6 (1.6, 49.9) months. The FEVAR procedure was technically successful in 93% of the patients. Five patients (3%) died in-hospital. Patient survival was 77% (95% CI 69% to 84%) at 3 years. Freedom from all-cause reintervention was 70% (95% CI 61% to 78%) at 3 years, and 33% of all-cause reinterventions were BECS associated. Complications were seen in 24 of 457 Advanta V12 BECSs: type 3 endoleak in 8 BECSs, significant stenosis in 4 BECSs, occlusion in 6 BECSs, and stent fractures in 3 BECSs. A combination of complications occurred in 3 BECSs: type 3 endoleak and stenosis, stent fracture and stenosis, and stent fracture and occlusion. The freedom from BECS-associated complications for Advanta V12 BECSs was 98% (95% CI 96% to 99%) at 1 year and 92% (95% CI 88% to 95%) at 3 years. The freedom from BECS-associated reinterventions was 98% (95% CI 95% to 100%) at 1 year and 94% (95% CI 91% to 97%) at 3 years. Conclusion: The Advanta V12 BECS used as bridging stent in FEVAR showed low complication and reintervention rates at 3 years. A substantial number of FEVAR patients required a reintervention, but most were not BECS related.