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In a trial involving patients with infrapopliteal artery disease, the use of a drug-eluting resorbable scaffold was superior to angioplasty in reducing reintervention and maintaining patency at 1 year.

IntroductionVasospasm is a morbid and often fatal complication of intracranial pathologies. Typically caused by aneurysmal subarachnoid hemorrhage (aSAH), it can also occur in association with intracranial infections. Heterogeneity exists in treatment regimens, but management usually involves intensive medical therapy. This may often require augmentation with endovascular therapy, most commonly intra-arterial calcium channel blocker infusion, with angioplasty historically reserved for refractory cases with a high risk for permanent neurological deficits. Given the high risk of iatrogenic complications with balloon angioplasty, alternative mechanical therapies have been explored. This series examines Dotter technique mechanical dilatation performed with Tenzing devices, or Tenzingplasty, of various sizes chosen to best approximate native premorbid calibers of affected arteries.MethodsAccording to IRB-approved protocols, retrospective analysis of prospectively maintained procedural databases and medical records was performed for patients undergoing Tenzingplasty at five high-volume cerebrovascular centers. Demographic and clinical features were recorded, including disease-specific features of vasospasm, details of pre-treatment management, noninvasive markers of vasospasm, technical elements of the Tenzingplasty procedure, and short-term clinical outcomes. Per-segment analysis was performed, including any treated arterial segment with narrowing >50%. The primary outcome was improvement of treated vessel narrowing to less than 50%. The primary safety outcome was any procedural complication. Secondary outcomes included absolute improvement in narrowing, post-treatment velocities on transcranial Doppler (TCD), and need for repeat endovascular therapy to be performed on a previously targeted segment. Statistical analysis was performed with the Exact test for non-continuous variables and T-tests for continuous variables. Mixed effects linear and logistic regression analysis was then performed as appropriate for multivariable analysis, excluding variables with p>0.20 in univariable tests to account for possible residual confounding.ResultsTwelve patients were treated with Tenzingplasty for vasospasm; 10 (83.3%) had aSAH, and 2 (16.7%) had meningitis. Tenzing devices were passed through 67 arterial segments. Among these, 56 (83.6%) had stenosis >50% and were included in the analysis. 73 passes were performed in total, with no procedural complications occurring after any treatment. All treated segments had improved narrowing, while 64 (95.5%) had residual narrowing <50%. 76.5% of segments interrogated with TCD following Tenzingplasty had normal velocities following treatment. Mean vessel narrowing improved from 79.9% ± 12.7 to 33.9% ± 14.2, with absolute improvement of narrowing 45.9% ± 16.6. Three (5.4%) segments required repeat endovascular therapy. In univariable and multivariable analysis, no demographic, clinical, or treatment variables were associated with any outcome measures.ConclusionTenzingplasty performed for vasospasm was safe and effective, with all vessel narrowing improving and 95.5% having <50% residual narrowing following the procedure. No procedural complications occurred in any treated segment. Improvement in post-treatment TCD velocities and low need for repeat endovascular therapy suggest durable clinical benefit.DisclosuresF. Behzadi: None. N. Mehta: None. W. Kim: 2; C; Route 92 Medical. 4; C; Route 92 Medical. F. Settecase: 2; C; Route 92 Medical. 4; C; Route 92 Medical. J. English: 2; C; Route 92 Medical, Stryker. 4; C; Route 92 Medical. J. Kim: 2; C; Route 92 Medical. 4; C; Route 92 Medical. B. Varjavand: None. T. Chaudhry: None. R. Khangura: None. N. Telischak: 2; C; Route 92 Medical. M. Alexander: 2; C; Certus Critical Care, Route 92 Medical, Medtronic, Ceronovus. 4; C; Piraeus Medical, Route 92 Medical.

IntroductionCoronary microvascular dysfunction (CMD) can persist following successful percutaneous coronary intervention (PCI). Endothelin-1 (ET-1) is a potent vasoconstrictor and may be an important mediator of CMD. We sought to assess the trans-myocardial gradient (TMG – coronary sinus minus coronary root levels) of ET-1 and its precursor - Big ET-1 and assess the correlation with pressure-wire indices of CMD: coronary flow reserve (CFR) and index of microvascular resistance (IMR).MethodsPaired blood samples from the aortic root and coronary sinus were collected before and after pressure wire guided PCI from patients with stable angina. Plasma was then analysed using specific enzyme linked immunosorbent assay (ELISA) for quantification of ET-1 and Big ET-1 and correlated with pressure-wire data.ResultsSamples were analysed from 66 patients. Both mean ET-1 and Big ET-1 concentrations increased post-PCI in both the aorta (ET-1: 1.0±0.4 pg/ml to 1.4±0.4 pg/ml, p<0.0001 and Big ET-1: 2.8±1.3 pg/ml to 3.4±1.6 pg/ml, p<0.0001) and coronary sinus (ET-1: 1.0±0.3 pg/ml to 1.2±0.3 pg/ml, p=0.03 and Big ET-1: 3.2±1.7 pg/ml to 3.8±1.5 pg/ml, p=0.01). TMG extraction of ET-1 increased following PCI: 0.05±0.25 pg/ml vs.-0.20±0.41 pg/ml, p=0.01. In contrast, there was TMG release of Big ET-1 before and after PCI: 0.46±1.26 pg/ml vs. 0.38±1.03 pg/ml, p=0.52 (figure 1). ET-1 extraction correlated with IMR post-PCI (Pearson’s r = 0.293, p=0.02, figure 2). Patients with CFR<2 post-PCI demonstrated a numerical trend towards higher mean ET-1 extraction than those with preserved CFR post-PCI (0.30±0.51 pg/ml vs. 0.16±0.42 pg/ml, p=0.31) as did those with criteria for Type 4a Myocardial Infarction compared with those without (0.39±0.57 vs. 0.15±0.41, p=0.11).Abstract 36 Figure 1ConclusionsET-1 and Big ET-1 significantly increase post-PCI. Trans-myocardial extraction of ET-1 increases post-PCI and correlates with post-PCI CMD.Conflict of Interestnone

IntroductionSubarachnoid haemorrhage (SAH) can result in cerebral vasospasms and delayed cerebral ischemia, which contribute significantly to morbidity and mortality. The effectiveness of endovascular treatment for this condition is still a subject of debate. However, the adjustable neck-bridging device Comaneci (Rapid Medical, Yokneam, Israel) may offer a safe and effective alternative to balloon angioplasty.Aim of StudyThe Comaneci Registry Trial is the first multicentre registry designed to evaluate the clinical and radiologic safety and efficacy of Comaneci in angioplasty of cerebral vasospasm in a standardized manner in patients with severe cerebral vasospasm after SAH.MethodsAll patients with severe vasospasm (>50%) in digital subtraction angiography (DSA) after aneurysmatic SAH treated with the Comaneci device as first-line therapy are included and evaluated through an angiographic vessel-by-vessel analysis using a 4-level scale as primary endpoint. All vessel-segments in anterior and posterior circulation up to M3-,A3- and P2-level are eligible for angioplasty with Comaneci. Clinical outcome is assessed with National Institutes of Health Stroke Scale (NIHSS) and modified Rankin Scale mRS.ResultsAlthough the study is still ongoing, the preliminary findings have demonstrated the safety and effectiveness of the treatment for vasospasm with Comaneci as a first-line angioplasty device.ConclusionThe Comaneci device has the potential to serve as a first-line device for providing therapeutic benefit to patients with SAH and vasospasm. However, future prospective trials are required.Disclosure of InterestNothing to disclose

ObjectivesAt this single centre, tri-modal monitoring of ICP, temperature and direct brain tissue oxygen tension (PbtO2) is used to guide management of delayed cerebral ischaemia (DCI). We describe our experience of PbtO2 monitoring and its relationship with symptoms of DCI, regional cerebral blood flow (rCBF, perfusion imaging), intra-arterial chemical angioplasty and CSF diversion.DesignProspective cohort.SubjectsPatients with aSAH who underwent over 24 hours of multi-modal PbtO2, temperature and intracranial pressure (ICP) monitoring via a Raumedic NEUROVENT-PTO probe.MethodsLongitudinal analysis of PbtO2 values, presented as mmHg (mean±SD).ResultsAnalysis of 1392 hours of tri-modal monitoring in 13 SAH patients. PbtO2 decreases >50% consistently reproduced focal neurological deficit. Symptomatic PbtO2 values ranged from 12–20 mmHg. Of the six patients who had reduced rCBF, all had a mean PbtO2 <15 mmHg. Five patients underwent intra-arterial chemical angioplasty (10 mg Verapamil in 100 ml NaCl over 30–40 mins). PbtO2 increased by at least 30% for 3.4±0.47 hours. CSF diversion resulted in a sustained mean increase in PbtO2 of 7.6±2.94 mmHg over the first 5 min (p=0.034).ConclusionsPbtO2 <15 mmHg may predict development of a clinical deficit. Chemical angioplasty resulted in a pronounced but short-lived increase in PbtO2. CSF diversion resulted in a persistent increase in PbtO2. PbtO2 targeted management may be a valuable addition to the clinicians’ arsenal against DCI.

BackgroundThere is strong evidence of FFR-guided treatment in multi-vessel disease. The presence of a concomitant CTO may influence the FFR measurement in donor vessel. We sought to investigate the influence of collateral regression after successful CTO recanalisation on donor vessel pressure-derived indices.Methods28 out of 34 consecutive patients underwent successful PCI to RCA CTOs and completed the follow up study (at 3 months post CTO-PCI). Resting Pd/Pa,iFR and FFR were measured pre and post successful CTO PCI and at follow-up in donor vessels.ResultsThe mean resting Pd/Pa, iFR and FFR pre and post-RCA CTO PCI and at follow-up procedures in major donor vessel were (0.893, 0.862, 0.764), (0.907, 0.886, 0.753) and (0.918, 0.901, 0.787) respectively. The mean resting Pd/Pa, iFR and FFR pre and post-RCA CTO PCI and at follow-up procedures in minor donor vessel were (0.979, 0.966, 0.890), (0.983, 0.979, 0.880) and (0.981, 0.974, 0.898) respectively. Changes in pressure-derived indices are summarised in table 1.Abstract 8 Table 1Changes in coronary pressure-derived measurements in donor vessel pre and post RCA CTO PCI and at fellow-up (FU: follow-up; PdPa: resting Pd/Pa; PCI: percutaneous coronary intervention; IFR: instantaneous wave-free ratio; FFR: fractional flow reserve; CTO: chronic total occlusion)ConclusionSuccessful recanalisation of a RCA CTO results in a significant increase in coronary pressure-derived indices of the major donor vessel at follow-up associated with a regression of collateral function. The expected change and the optimal timing to perform PCI in donor vessel should be considered when planning multi-vessel revascularisation in this setting.

AbstractObjectivesTo investigate whether a less intense antiplatelet regimen could be used for people receiving drug coated balloons.DesignMulticentre, randomised, open label, assessor blind, non-inferiority trial (REC-CAGEFREE II).Setting41 hospitals in China between 27 November 2021 and 21 January 2023.Participants1948 adults (18-80 years) with acute coronary syndrome who received treatment exclusively with paclitaxel-coated balloons according to the international drug coated balloon consensus.InterventionsParticipants were randomly assigned (1:1) to either the stepwise dual antiplatelet therapy (DAPT) de-escalation group (n=975) consisting of aspirin plus ticagrelor for one month, followed by five months of ticagrelor monotherapy, and then six months of aspirin monotherapy, or to the standard DAPT group (n=973) consisting of aspirin plus ticagrelor for 12 months.Main outcome measuresThe primary endpoint was net adverse clinical events (all cause death, stroke, myocardial infarction, revascularisation, and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding) at 12 months in the intention-to-treat population. Non-inferiority was established if the upper limit of the one sided 95% confidence interval (CI) for the absolute risk difference was smaller than 3.2%.ResultsThe mean age of participants was 59.2 years, 74.9% were men, 30.5% had diabetes, and 20.6% were at high bleeding risk. 60.9% of treated lesions were in small vessels, and 17.8% were in-stent restenosis. The mean drug coated balloon diameter was 2.72 mm (standard deviation 0.49). At 12 months, the primary endpoint occurred in 87 (8.9%) participants in the stepwise de-escalation group and 84 (8.6%) in the standard group (difference 0.36%; upper boundary of the one sided 95% CI 2.47%; Pnon-inferiority=0.013). In the stepwise de-escalation versus standard groups, BARC type 3 or 5 bleeding occurred in four versus 16 participants (0.4% v 1.6%, difference −1.19% (95% CI −2.07% to −0.31%), P=0.008), and all cause death, stroke, myocardial infarction, and revascularisation occurred in 84 versus 74 participants (8.6% v 7.6%, difference 1.05% (95% CI −1.37% to 3.47%), P=0.396). Treated as having hierarchical clinical importance by the win ratio method, more wins were noted with the stepwise de-escalation group (14.4% wins) compared with the standard group (10.1% wins) for the predefined hierarchical composite endpoint of all cause death, stroke, myocardial infarction, BARC type 3 bleeding, revascularisation, and BARC type 2 bleeding (win ratio 1.43 (95% CI 1.12 to 1.83), P=0.004). Results from the per-protocol and the intention-to-treat analysis were similar.ConclusionsAmong participants with acute coronary syndrome who could be treated by drug coated balloons exclusively, a stepwise DAPT de-escalation was non-inferior to 12 month DAPT for net adverse clinical events.Trial registrationClinicaltrials.gov NCT04971356

Purpose To evaluate longer outcomes of primary nitinol stenting for the treatment of femoropopliteal lesions up to 15 cm long after these stents were found to have superior short-term patency vs. balloon angioplasty. Methods Two hundred and six patients (143 men; mean age 67 years) with intermittent claudication due to superficial femoral and proximal popliteal artery lesions were randomized (2:1) to treatment with nitinol stents or balloon angioplasty at 24 US and European centers and followed for 3 years. In that time, 15 patients died, 20 withdrew consent, and 10 were lost to follow-up, leaving 161 (78.2%) patients for 36-month assessment. Results The 12-month freedom from target lesion revascularization (TLR) was 87.3% for the stent group vs. 45.2% for the angioplasty group (p<0.0001). At 3 years, there was no difference in survival (90.0% vs. 91.7%, p=0.71) or major adverse events (75.2% vs. 75.2%, p=0.98) between the stent and angioplasty groups. Duplex ultrasound was not mandated after the first year, so stent patency could not be ascertained beyond 1 year, but freedom from TLR at 3 years was significantly better in the stent group (75.5% vs. 41.8%, p<0.0001), as was clinical success (63.2% vs. 17.9%, p<0.0001). At 18 months, a 4.1% (12/291) stent fracture rate was documented. Conclusion In this multicenter trial, primary implantation of a nitinol stent for moderate-length lesions in the femoropopliteal segment of patients with claudication was associated with better long-term results vs. balloon angioplasty alone.

AbstractObjectiveTo determine which primary endovascular revascularisation strategy represents the most clinically effective treatment for patients with chronic limb threatening ischaemia who require endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.DesignThree arm, open label, pragmatic, multicentre, randomised, phase 3 superiority trial (BASIL-3).Setting35 UK NHS vascular units.ParticipantsPatients with chronic limb threatening ischaemia who required endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.InterventionsParticipants were randomly assigned (1:1:1) to femoro-popliteal plain balloon angioplasty with or without bare metal stenting (PBA±BMS), drug coated balloon angioplasty with or without bare metal stenting (DCBA±BMS), or drug eluting stenting (DES) as their first revascularisation strategy.Main outcome measuresThe primary outcome was amputation free survival defined as time to first major amputation or death from any cause. Secondary outcomes included the composite components of the primary outcome, major adverse limb events, major adverse cardiac events, and other prespecified clinical and patient reported outcome measures. Serious adverse events were collected up to 30 days after the first revascularisation procedure.ResultsBetween 29 January 2016 and 31 August 2021, 481 participants were randomised (167 (35%) women, mean age 71.8 years (standard deviation 10.8)). Major amputation or death occurred in 106 of 160 (66%) participants in the PBA±BMS group, 97 of 161 (60%) in the DCBA±BMS group, and 93 of 159 (58%) in the DES group (adjusted hazard ratios: PBA±BMS v DCBA±BMS: 0.84, 97.5% confidence interval 0.61 to 1.16, P=0.22; PBA±BMS v DES: 0.83, 0.60 to 1.15, P=0.20). No differences in serious adverse events were reported between the groups.ConclusionsNeither DCBA±BMS nor DES conferred significant clinical benefit over PBA±BMS in the femoro-popliteal segment in patients with chronic limb threatening ischaemia undergoing endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.Trial registrationISRCTN registry ISRCTN14469736

In this trial, patients with femoropopliteal artery disease were assigned to standard angioplasty or treatment with a paclitaxel-coated balloon. At 12 months, primary patency was seen more frequently with the drug-coated balloon than with standard angioplasty. Atherosclerotic disease in the femoral and popliteal (femoropopliteal) arteries compromises perfusion to the legs and feet. Although treatment with percutaneous transluminal angioplasty is effective in initially restoring blood flow, restenosis from vessel recoil and neointimal hyperplasia occur in more than 60% of patients within 1 year after the procedure. 1 Stents act as scaffolds to prevent recoil and reduce the incidence of restenosis, 2 – 9 but the permanent presence of an intravascular prosthesis may limit subsequent therapeutic options. Stent fracture, although infrequent, can have negative consequences. 10 – 13 Results with drug-eluting stents in peripheral vessels have varied, 14 – 18 although a recent study showed . . .