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Catheter Aspiration after Every Stage during Primary Percutaneous Angioplasty; ADMIT Trial.

ABSTRACT: We assess the epicardial and microcirculation flow characteristics, and clinical outcome by using catheter aspiration after each stage of primary percutaneous coronary intervention (PPCI). Conflicting data are reported regarding early and late benefit of using aspiration catheter in the initial phase PPCI. A total of 100 patients with ST-segment elevation acute myocardial infarction (STEMI) were included: 51 underwent PPCI without using an aspiration device (SA group) and 49 underwent PPCI by activating an aspiration catheter after each stage of procedure; wiring, ballooning and stenting, respectively (MA group). Thrombolysis in myocardial infarction (TIMI) flow grade, TIMI frame counts and myocardial blush grade (MBG) were evaluated in each group during every stage of procedure. Major adverse cardiac events were evaluated in the index hospitalization and during 30 and 180 days of follow-up. A TIMI flow grade 2-3 was more prevalent in the MA group compared with the SA group only after wiring: 65.9 versus 39.1% (p = 0.01), but TIMI frame counts were lower in the MA versus SA group throughout all procedural steps. MBG 2-3 was statistically higher in the MA group compared with the SA group mainly after wiring. After stenting there were no significant changes in both epicardial and microcirculation flow parameters. There were no significant differences between the groups in early and late clinical outcomes. Improved flow parameters were noticed in the MA group only by activating the aspiration device after wiring. This early advantage disappeared after stenting. The initial better flow characteristic in the MA group was not translated into a better early or late clinical outcome.

SUBMITTER: Turgeman Y

PROVIDER: S-EPMC3933502 | biostudies-other | 2014 Mar

REPOSITORIES: biostudies-other

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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.

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.

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Catheter Aspiration after Every Stage during Primary Percutaneous Angioplasty; ADMIT Trial.

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