Dataset Information

Sequential Venous Percutaneous Transluminal Angioplasty and Balloon Dilatation of the Interatrial Septum during Percutaneous Edge-to-Edge Mitral Valve Repair.

ABSTRACT: Percutaneous edge-to-edge mitral valve repair (PMVR) is widely used for selected, high-risk patients with severe mitral valve regurgitation (MR). This report describes a case of 81-year-old woman presenting with severe and highly symptomatic mitral valve regurgitation (MR) caused by a flail of the posterior mitral valve leaflet (PML). PMVR turned out to be challenging in this patient because of a stenosis and tortuosity of both iliac veins as well as sclerosis of the interatrial septum, precluding the vascular and left atrial access by standard methods, respectively. We managed to achieve atrial access by venous percutaneous transluminal angioplasty (PTA) and balloon dilatation of the interatrial septum. Subsequently, we could advance the MitraClip® system to the left atrium, and deployment of the clip in the central segment of the mitral valve leaflets (A2/P2) resulted in a significant reduction of MR.

SUBMITTER: Jorbenadze R

PROVIDER: S-EPMC5568623 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Sequential Venous Percutaneous Transluminal Angioplasty and Balloon Dilatation of the Interatrial Septum during Percutaneous Edge-to-Edge Mitral Valve Repair.

Jorbenadze Rezo R Patzelt Johannes J Gawaz Meinrad M Seizer Peter P Langer Harald F HF

Case reports in cardiology 20170809

Percutaneous edge-to-edge mitral valve repair (PMVR) is widely used for selected, high-risk patients with severe mitral valve regurgitation (MR). This report describes a case of 81-year-old woman presenting with severe and highly symptomatic mitral valve regurgitation (MR) caused by a flail of the posterior mitral valve leaflet (PML). PMVR turned out to be challenging in this patient because of a stenosis and tortuosity of both iliac veins as well as sclerosis of the interatrial septum, precludi ...[more]

PMID: 28852577

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Project description:BackgroundVertebral artery stenosis (narrowing of the vertebral artery) is an important cause of posterior circulation ischaemic stroke. Medical treatment (MT) e.g. controlling risk-factors and drug treatment, surgery, and endovascular treatment (ET) are the prevailing treatment strategies for symptomatic vertebral artery stenosis. ET consist s of percutaneous transluminal angioplasty (balloon catheter through the skin), with or without stenting. However, optimal management of people with symptomatic vertebral artery stenosis has not yet been established.ObjectivesTo assess the safety and efficacy of percutaneous transluminal angioplasty, with or without stenting, combined with MT, compared to MT alone, in people with episodes of cerebral ischaemia due to vertebral artery stenosis.Search methodsWe searched the Cochrane Stroke Group, MEDLINE, Embase, BIOSIS, and two other indexes in Web of Science, China Biological Medicine Database, Chinese Science and Technique Journals Database, China National Knowledge Infrastructure and Wanfang Data, as well as ClinicalTrials.gov trials register and the World Health Organization (WHO) International Clinical Trials Registry Platform to 23 July 2021.Selection criteriaWe included all randomised controlled trials (RCTs) that compared ET plus MT with MT alone in treating people aged 18 years or over with symptomatic vertebral artery stenosis. We included all types of ET modalities (e.g. angioplasty alone, balloon-mounted stenting, and angioplasty followed by placement of a self-expanding stent). MT included risk factor control, antiplatelet therapy, lipid-lowering therapy, and individualised management for people with hypertension or diabetes.Data collection and analysisTwo review authors independently screened potentially eligible studies, extracted data, and assessed trial quality and risk of bias. We applied the GRADE approach to assess the certainty of evidence. The primary outcomes were 30-day post-randomisation death/stroke (short-term outcome) and fatal/non-fatal stroke after 30 days post-randomisation to completion of follow-up (long-term outcome). MAIN RESULTS: We included three RCTs with 349 participants with symptomatic vertebral artery stenosis with a mean age of 64.4 years. The included RCTs were at low risk of bias overall. However, all included studies had a high risk of performance bias because blinding of the ET was not feasible. There was no significant difference in 30-day post-randomisation deaths/strokes between ET plus MT and MT alone (risk ratio (RR) 2.33, 95% confidence interval (CI) 0.77 to 7.07; 3 studies, 349 participants; low-certainty evidence). There were no significant differences between ET plus MT and MT alone in fatal/non-fatal strokes in the territory of the treated vertebral artery stenosis after 30 days post-randomisation to completion of follow-up (RR 0.51, 95% CI 0.26 to 1.01; 3 studies, 349 participants; moderate-certainty evidence), ischaemic or haemorrhagic stroke during the entire follow-up period (RR 0.77, 95% CI 0.44 to 1.32; 3 studies, 349 participants; moderate-certainty evidence), death during the entire follow-up period (RR 0.78, 95% CI 0.37 to 1.62; 3 studies, 349 participants; low-certainty evidence), and stroke or transient ischaemic attack (TIA) during the entire follow-up period (RR 0.65, 95% CI 0.39 to 1.06; 2 studies, 234 participants; moderate-certainty evidence).Authors' conclusionsThis Cochrane Review provides low- to moderate-certainty evidence indicating that there are no significant differences in either short- or long-term risks of stroke, death, or TIA between people with symptomatic vertebral artery stenosis treated with ET plus MT and those treated with MT alone.

Project description:BackgroundNumerous studies have reported favorable outcomes using drug-coated balloons (DCBs) for treatment of symptomatic peripheral artery disease of the superficial femoral and popliteal arteries. However, the treatment effect compared with an uncoated balloon has differed greatly among the randomized trials, with better outcomes observed with higher-dose DCBs. This European trial was designed to assess the safety and effectiveness of a next-generation low-dose (2-µg/mm2 surface dose of paclitaxel) DCB.MethodsThis was a prospective, randomized, multicenter, single-blinded trial. Patients were randomized (3:1) to treatment with a low-dose DCB or an uncoated percutaneous transluminal angioplasty (PTA) balloon. The primary safety end point was a composite of freedom from device- and procedure-related death through 30 days after the procedure and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months after the procedure. The primary effectiveness end point was primary patency at 12 months.ResultsPatients were randomized to treatment with a DCB (222 patients, 254 lesions) or uncoated PTA balloon (72 patients, 79 lesions) after successful predilatation. Mean lesion length was 7.2 and 7.1 cm, and 19.2% and 19.0% of lesions represented total occlusions, respectively. The primary safety end point was met, and superiority was demonstrated; freedom from a primary safety event was 94.1% (193 of 205) with DCB and 83.3% (50 of 60) with PTA, for a difference of 10.8% (95% confidence interval, 0.9%-23.0%). The primary effectiveness end point was met, and superiority of DCB over PTA was achieved (83.9% [188 of 224] versus 60.6% [40 of 66]; P<0.001). Outcomes with DCB were also superior to PTA per the Kaplan-Meier estimate for primary patency (89.0% versus 65.0% at 365 days; log-rank P<0.001) and for rates of clinically driven target lesion revascularization (5.9% versus 16.7%; P=0.014).ConclusionsSuperiority with a low-dose DCB for femoropopliteal interventions was demonstrated over PTA for both the safety and effectiveness end points.Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01858363.

Project description:BackgroundTo treat stenosed coronary arteries, percutaneous transluminal coronary angioplasty (PTCA) balloon catheters must combine pushability, trackability, crossability, and rewrap behavior. The existing anatomic track model (ASTM F2394) for catheter testing lacks 3D morphology, vessel tortuosity, and compliance, making evaluating performance characteristics difficult. This study aimed to develop a three-dimensional patient-specific phantom (3DPSP) for device testing and safe training for interventional cardiologists.MethodsA range of silicone materials with different shore hardnesses (00-30-45 A) and wall thicknesses (0.5 mm, 1 mm, 2 mm) were tested to determine compliance for creating coronary vessel phantoms. Compliance was assessed using optical coherence tomography (OCT) and compared to values in the literature. Stenosis was induced using multilayer casting and brushing methods, with gypsum added for calcification. The radial tensile properties of the samples were investigated, and the relationship between Young's modulus and compliance was determined. Various methods have been introduced to approximate the friction between silicone and real coronary vessel walls. Computerized tomography (CT) scans were used to obtain patient-specific anatomy from the femoral artery to the coronary arteries. Artery lumens were segmented from the CT scans to create dissolvable 3D-printed core models.ResultsA 15A shore hardness silicone yielded an experimental compliance of 12.3-22.4 mm2mmHg·103 for stenosed tubes and 14.7-57.9 mm2mmHg·103 for uniform tubes, aligning closely with the literature data (6.28-40.88 mm2mmHg·103 ). The Young's modulus ranged from 43.2 to 75.5 kPa and 56.6-67.9 kPa for the uniform and calcified materials, respectively. The dependency of the compliance on the wall thickness, Young's modulus, and inner diameter could be shown. Introducing a lubricant reduced the silicone friction coefficient from 0.52 to 0.13. The 3DPSP was successfully fabricated, and comparative analyses were conducted among eight commercially available catheters.ConclusionThis study presents a novel method for crafting 3DPSPs with realistic mechanical and frictional properties. The proposed approach enables the creation of comprehensive and anatomically precise setups spanning the right femoral artery to the coronary arteries, highlighting the importance of such realistic environments for advancing medical device development and fostering safe training conditions.

Dataset Information

Sequential Venous Percutaneous Transluminal Angioplasty and Balloon Dilatation of the Interatrial Septum during Percutaneous Edge-to-Edge Mitral Valve Repair.

Publications

Sequential Venous Percutaneous Transluminal Angioplasty and Balloon Dilatation of the Interatrial Septum during Percutaneous Edge-to-Edge Mitral Valve Repair.

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