Target Vessel Revascularization Research Articles

Long-term impact of intravascular ultrasound-guidance for percutaneous coronary intervention on unprotected left main. The IMPACTUS-LM, an observational, multicentric study

IntroductionThe potential benefit on long term outcomes of Percutaneous Coronary Intervention (PCI) on Unprotected Left Main (ULM) driven by IntraVascular UltraSound (IVUS) remains to be defined. MethodsIMPACTUS LM-PCI is an observational, multicenter study that enrolled consecutive patients with ULM disease undergoing coronary angioplasty in 13 European high-volume centers from January 2002 to December 2015. Major Adverse Cardiovascular Events (MACEs) a composite of cardiovascular (CV) death, target vessel revascularization (TVR) and myocardial infarction (MI) were the primary endpoints, while its single components along with all cause death the secondary ones. Results627 patients with ULM disease were enrolled, 213 patients (34%) underwent IVUS-guided PCI while 414 (66%) angioguided PCI. Patients in the two cohorts had similar prevalence of risk factors except for active smoking and clinical presentation. During a median follow-up of 7.5 years, 47 (22%) patients in the IVUS group and 211 (51%) in the angio-guided group underwent the primary endpoint (HR 0.42; 95% CI [0.31–0.58] p < 0.001). After multivariate adjustment, IVUS was significantly associated with a reduced incidence of the primary endpoint (adj HR 0.39; 95% CI [0.23–0.64], p < 0.001), mainly driven by a reduction of TVR (ad HR 0.30, 95% CI [0.15–0.62], p = 0.001) and of all-cause death (adj HR 0.47, 95% CI [0.28–0.82], p = 0.008). IVUS use, age, diabetes, side branch stenosis, DES and creatinine at admission were independent predictors of MACE. ConclusionsIn patients undergoing ULM PCI, the use of IVUS was associated with a reduced risk at long-term follow-up of MACE, all-cause death and subsequent revascularization.

Invasiveness of previous treatment for peripheral arterial disease and risk of adverse cardiac events after coronary stenting

Patients with peripheral arterial disease (PADs), undergoing percutaneous coronary intervention (PCI), have higher adverse event risks. The effect of invasiveness of PADs treatment on PCI outcome is unknown. This study assessed the impact of the invasiveness of previous PADs treatment (invasive or non-invasive) on event risks after PCI with contemporary drug-eluting stents. This post-hoc analysis pooled 3-year patient-level data of PCI all-comer patients living in the eastern Netherlands, previously treated for PADs. PADs included symptomatic atherosclerotic lesion in the lower or upper extremities; carotid or vertebral arteries; mesenteric arteries or aorta. Invasive PADs treatment comprised endarterectomy, bypass surgery, percutaneous transluminal angioplasty, stenting or amputation; non-invasive treatment consisted of medication and participation in exercise programs. Primary endpoint was (coronary) target vessel failure: composite of cardiac mortality, target vessel-related myocardial infarction, or clinically indicated target vessel revascularization. Of 461 PCI patients with PADs, information on PADs treatment was available in 357 (77.4%) patients; 249 (69.7%) were treated invasively and 108 (30.3%) non-invasively. Baseline and PCI procedural characteristics showed no between-group difference. Invasiveness of PADs treatment was not associated with adverse event risks, including target vessel failure (20.5% vs. 16.0%; HR: 1.30, 95%-CI 0.75–2.26, p = 0.35), major adverse cardiac events (23.3% vs. 20.4%; HR: 1.16, 95%-CI 0.71–1.90, p = 0.55), and all-cause mortality (12.1% vs. 8.3%; HR: 1.48, 95%-CI 0.70–3.13, p = 0.30). In PADs patients participating in PCI trials, we found no significant relation between the invasiveness of previous PADs treatment and 3-year outcome after PCI. Consequently, high-risk PCI patients can be identified by consulting medical records, searching for PADs, irrespective of the invasiveness of PADs treatment.Graphical abstractComparison of patients with non-invasive and invasive PADs treatment. PADs peripheral arterial disease, PCI percutaneous coronary intervention.

Coronary Angiography, Intravascular Ultrasound, and Optical Coherence Tomography for Guiding of Percutaneous Coronary Intervention: A Systematic Review and Network Meta-Analysis.

Results from multiple randomized clinical trials comparing outcomes after intravascular ultrasound (IVUS)- and optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) with invasive coronary angiography (ICA)-guided PCI as well as a pivotal trial comparing the 2 intravascular imaging (IVI) techniques have provided mixed results. Major electronic databases were searched to identify eligible trials evaluating at least 2 PCI guidance strategies among ICA, IVUS, and OCT. The 2 coprimary outcomes were target lesion revascularization and myocardial infarction. The secondary outcomes included ischemia-driven target lesion revascularization, target vessel myocardial infarction, death, cardiac death, target vessel revascularization, stent thrombosis, and major adverse cardiac events. Frequentist random-effects network meta-analyses were conducted. The results were replicated by Bayesian random-effects models. Pairwise meta-analyses of the direct components, multiple sensitivity analyses, and pairwise meta-analyses IVI versus ICA were supplemented. The results from 24 randomized trials (15 489 patients: IVUS versus ICA, 46.4%, 7189 patients; OCT versus ICA, 32.1%, 4976 patients; OCT versus IVUS, 21.4%, 3324 patients) were included in the network meta-analyses. IVUS was associated with reduced target lesion revascularization compared with ICA (odds ratio [OR], 0.69 [95% CI, 0.54-0.87]), whereas no significant differences were observed between OCT and ICA (OR, 0.83 [95% CI, 0.63-1.09]) and OCT and IVUS (OR, 1.21 [95% CI, 0.88-1.66]). Myocardial infarction did not significantly differ between guidance strategies (IVUS versus ICA: OR, 0.91 [95% CI, 0.70-1.19]; OCT versus ICA: OR, 0.87 [95% CI, 0.68-1.11]; OCT versus IVUS: OR, 0.96 [95% CI, 0.69-1.33]). These results were consistent with the secondary outcomes of ischemia-driven target lesion revascularization, target vessel myocardial infarction, and target vessel revascularization, and sensitivity analyses generally did not reveal inconsistency. OCT was associated with a significant reduction of stent thrombosis compared with ICA (OR, 0.49 [95% CI, 0.26-0.92]) but only in the frequentist analysis. Similarly, the results in terms of survival between IVUS or OCT and ICA were uncertain across analyses. A total of 25 randomized trials (17 128 patients) were included in the pairwise meta-analyses IVI versus ICA where IVI guidance was associated with reduced target lesion revascularization, cardiac death, and stent thrombosis. IVI-guided PCI was associated with a reduction in ischemia-driven target lesion revascularization compared with ICA-guided PCI, with the difference most evident for IVUS. In contrast, no significant differences in myocardial infarction were observed between guidance strategies.

Thoracoabdominal Aortic Aneurysm Repair Using Fenestrated and Branched Endovascular Grafts for High-Risk Patients: Evolving yet Safe

Purpose: The purpose was to investigate outcomes of high-risk patients undergoing thoracoabdominal aortic aneurysm (TAAA) repair using fenestrated or branched endovascular aneurysm repair (F/BEVAR) devices at a single center in Canada. Materials and Methods: A retrospective review of all patients undergoing endovascular TAAA repair with F/BEVAR from June 2007 to July 2020. Imaging and clinical endpoints of interest including death, reintervention, and target vessel patency were reported. Results: Ninety-five consecutive patients underwent endovascular TAAA repair using F/BEVAR stent grafts (63 males, median age 74 [interquartile range 70, 78] years). Repairs included 81 elective and 14 urgent/emergent cases (6 ruptures and 8 symptomatic). Graft deployment was 100% successful. Intraoperative target vessel revascularization was successful in 336/355 (94.6%) vessels with the celiac having the lowest success rate 72/82 (87.8%). In-hospital mortality was 9.5% (7.4% elective and 21.4% urgent/emergent, p=0.125) and permanent paraplegia was 4.2% (3.7% elective and 7.1% urgent/emergent, p=0.458). In-hospital complications included stroke in 5.3%, acute myocardial infarction in 8.4%, and bowel ischemia in 5.3%. No patients required permanent dialysis or tracheostomy during their hospital stay. However, 22 (23.2%) patients required additional unplanned procedures for various indications (branch occlusion, endoleaks, realignment) during their hospital stay. Patients were followed up for a mean of 3.6 ± 3.0 years. Clinical follow-up was 100%, with 80/86 (93%) having surveillance imaging. On follow-up imaging, 43 (50%) patients had at least 1 endoleak identified and 337/341 (98.8%) of the target vessels were found to be patent. At 5 years, cumulative probability of reintervention was 46.3% (95% confidence interval [CI], 36.1-56.4). Survival at 5 and 8 years was 50.1% (95% CI, 38.4-65.4) and 34.4% (95% CI, 22.5-52.8), respectively. Progression of aneurysmal disease leading to rupture on follow-up was confirmed in 1 patient at 10 years. Conclusion: Endovascular TAAA repair provides a safe treatment option with a high technical success rate and low pulmonary and renal complications. Long-term survival is similar to previous literature; however, high rates of secondary reintervention reaffirm the need for ongoing patient follow-up and further technical improvements. Clinical Impact This study demonstrates that endovascular repair of TAAAs can be performed in a high-risk elderly population with acceptable rates of mortality, TALE and SCI, using evolving technology. The incidences of post-operative respiratory failure and renal dysfunction were lower in patients who underwent endovascular repair compared with open repair. Future technical and procedural refinements in addition to increasing surgical experience are expected to lead to further improvements in short- and long-term outcomes exceeding those of open repair.

Performance of the minimalistic hybrid approach algorithm versus other conventional algorithms in the percutaneous treatment of chronic total occlusions.

The "Minimalistic Hybrid Approach" (MHA) has been proposed to reduce the invasiveness of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). This study aims to assess whether MHA may also reduce the utilization of PCI resources (devices, radiations, and contrast) by comparing it with other conventional algorithms. We aimed to assess the impact of MHA on device, radiation, and contrast usage during CTO-PCI analyzing data from the Belgian Working Group on CTO (BWG-CTO) registry. Patients were divided, depending on the algorithm used, into two groups: Conventional versus Minimalistic. Primary objectives were procedure performance measures such as device usage (microcatheters and guidewires), radiological parameters, and contrast use. At 1-year follow-up, patients were evaluated for target vessel failure (TVF), defined as a composite of cardiac death, new myocardial infarction, and target vessel revascularization. Overall, we analyzed 821 CTO-PCIs (Conventional n = 650, Minimalistic n = 171). The Minimalistic group demonstrated higher complexity of CTO lesions. After adjusting for propensity score, the Minimalistic group had a significantly lower number of microcatheters used (1.49 ± 0.85 vs. 1.24 ± 0.64, p = 0.026), while the number of guidewires was comparable (4.80 ± 3.29 vs. 4.35 ± 2.94, p = 0.30). Both groups had similar rates of success and procedural complications, as well as comparable procedural and fluoroscopic times and contrast volume used. At the 1-year follow-up, both groups showed comparable rates of TVF (hazard ratio: 0.57; 95% confidence interval: 0.24-1.34, p = 0.195). The MHA may slightly reduce the number of dedicated devices used during CTO-PCI, without adversely affecting the procedural success or long-term outcome.

A Comparison of 2 Paclitaxel-Coated Balloon Systems in Treatment of De Novo Coronary Artery Lesions

BackgroundIn percutaneous coronary intervention (PCI) of de novo lesions, drug-coated balloons (DCB) have been shown to be a promising strategy to improve clinical outcomes of patients with small vessel disease. Evidence of this strategy in PCI of de novo coronary lesions in a real-world setting is limited. The objective of this study was to compare the 12-month outcomes of 2 paclitaxel-coated balloon systems for the treatment of all de novo coronary artery lesions. MethodsAll patients who were treated for de novo coronary artery stenosis with either SeQuent Please or In.Pact Falcon DCB at a single center from January 2014 to December 2018 were included. The primary end point was the composite of cardiac death, nonfatal myocardial infarction, and target vessel revascularization (3-point major adverse cardiovascular events) at 12 months. ResultsA total of 496 patients with 623 lesions, of which 144 were treated with SeQuent Please and 352 were treated with In.Pact Falcon were included in the study. Baseline patient, lesion and procedural characteristics at baseline were similar between groups. At 12-month follow-up, 3-point major adverse cardiovascular event outcomes were similar (4.2% vs 2.3% respectively; P = .272). Deaths due to cardiovascular events were few and similar between groups (2.7% vs 1.1% respectively; P = .20). ConclusionsBoth paclitaxel DCB systems have similar efficacy and safety outcomes, suggesting that both may be an appropriate treatment choice for patients with de novo lesions. However, a larger randomized controlled study is needed to confirm these findings.

TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and multivessel or advanced coronary disease: The transcatheter valve and vessels trial (TCW trial): Design and rationale

Background: Patients with severe aortic stenosis (AS) frequently present with concomitant obstructive coronary artery disease (CAD). In those, current guidelines recommend combined coronary artery bypass grafting (CABG) and surgical aortic valve replacement (SAVR) as the preferred treatment option, although this surgical approach is associated with a high rate of clinical events. Combined transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) with or without FFR have evolved as a valid alternative for cardiac surgery in patients with AS and multivessel or advanced CAD. To date, no dedicated trial has prospectively evaluated the outcomes of a percutaneous versus surgical treatment for patients with both severe AS and CAD. Aims: To investigate whether fractional-flow reserve (FFR)-guided PCI and TAVI is non-inferior to combined CABG and SAVR for the treatment of severe AS and multivessel or advanced CAD. Methods: The Transcatheter Valve and Vessels (TCW) trial (clinicaltrial.gov: NCT03424941) is a prospective, randomized, controlled, open label, international trial. Patients ≥ 70 years with severe AS and multivessel (≥ 2 vessels) or advanced CAD, deemed feasible by the heart team for both; a full percutaneous or surgical treatment, will be randomised in a 1:1 fashion to either FFR-guided PCI followed by TAVI (intervention arm) vs. CABG and SAVR (control arm). The primary endpoint is a patient-oriented composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve re-intervention, and life threatening or disabling bleeding at one year. The TCW trial is powered for non-inferiority, and if met, superiority will be tested. Assuming a primary endpoint rate of 30% in the CABG-SAVR arm, with a significance level α of 5%, a non-inferiority limit delta of 15% and a loss to follow-up of 2%, a total of 328 patients are needed to obtain a power of 90%. The primary endpoint analysis is performed on an intention-to-treat basis. Summary: The TCW Trial is the first prospective randomized trial that will study if a less invasive percutaneous treatment for severe AS and concomitant advanced CAD (i.e., FFR-guided PCI - TAVI) is non-inferior to the guidelines recommended approach (CABG-SAVR).

Five-Year Safety and Effectiveness of Paclitaxel Drug-Coated Balloons Alone or With Provisional Bare Metal Stenting for Real-World Femoropopliteal Lesions: IN.PACT Global Study Subgroup Analysis.

The treatment of complex infra-inguinal disease with drug-coated balloons (DCBs) is associated with a significant number of patients undergoing provisional stenting to treat a suboptimal result. To determine the potential long-term impact of DCB treatment with provisional bare metal stenting in complex lesions in real-world patients, a post hoc analysis was performed on data from the IN.PACT Global Study (The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral Drug-Eluting Balloon). Five-year outcomes were compared between participants who were stented after DCB treatment versus those treated with DCB alone. The IN.PACT Global Study enrolled 1535 participants with intermittent claudication and/or ischemic rest pain caused by femoropopliteal lesions; 1397 patients were included in this subgroup analysis (353 stented and 1044 nonstented). Effectiveness was assessed as freedom from clinically driven target lesion revascularization through 60 months. The primary safety composite end point was defined as freedom from device- and procedure-related death through 30 days, and freedom from major target limb amputation and clinically driven target vessel revascularization through 60 months. Lesions in the stented group were longer (15.37 versus 10.98 cm; P<0.001) and had more total occlusions (54.7% versus 28.6%; P<0.001) compared with the nonstented group. The 5-year Kaplan-Meier estimated freedom from clinically driven target lesion revascularization was similar between groups (66.8% stented versus 70.0% nonstented group, log-rank P=0.22). The safety composite end point was achieved in 64.5% stented versus 68.2% nonstented participants (log-rank P=0.19) as estimated by the Kaplan-Meier method. No significant difference was observed in the cumulative incidence of major adverse events (49.1% stented versus 45.0% nonstented; log-rank P=0.17), including all-cause death (19.6% stented versus 19.3% nonstented, log-rank P=0.99). In this real-world study, revascularization of complex femoropopliteal artery lesions with DCB angioplasty alone or DCB followed by provisional bare metal stenting in certain lesions achieved comparable long-term safety and clinical effectiveness. URL: https://www.clinicaltrials.gov; Unique identifier: NCT01609296.

Covered versus bare-metal stenting of the mesenteric arteries in patients with chronic mesenteric ischaemia (CoBaGI): a multicentre, patient-blinded and investigator-blinded, randomised controlled trial

Mesenteric artery stenting with a bare-metal stent is the current treatment for atherosclerotic chronic mesenteric ischaemia. Long-term patency of bare-metal stents is unsatisfactory due to in-stent intimal hyperplasia. Use of covered stents might improve long-term patency. We aimed to compare the patency of covered stents and bare-metal stents in patients with chronic mesenteric ischaemia. We conducted a multicentre, patient-blinded and investigator-blinded, randomised controlled trial including patients with chronic mesenteric ischaemia undergoing mesenteric artery stenting. Six centres in the Netherlands participated in this study, including two national chronic mesenteric ischaemia expert centres. Patients aged 18 years or older were eligible for inclusion when an endovascular mesenteric artery revascularisation was scheduled and a consensus diagnosis of chronic mesenteric ischaemia was made by a multidisciplinary team of gastroenterologists, interventional radiologists, and vascular surgeons. Exclusion criteria were stenosis length of 25 mm or greater, stenosis caused by median arcuate ligament syndrome or vasculitis, contraindication for CT angiography, or previous target vessel revascularisation. Digital 1:1 block randomisation with block sizes of four or six and stratification by inclusion centre was used to allocate patients to undergo stenting with bare-metal stents or covered stents at the start of the procedure. Patients, physicians performing follow-up, investigators, and radiologists were masked to treatment allocation. Interventionalists performing the procedure were not masked. The primary study outcome was the primary patency of covered stents and bare-metal stents at 24 months of follow-up, evaluated in the modified intention-to-treat population, in which stents with missing data for the outcome were excluded. Loss of primary patency was defined as the performance of a re-intervention to preserve patency, or 75% or greater luminal surface area reduction of the target vessel. CT angiography was performed at 6 months, 12 months, and 24 months post intervention to assess patency. The study is registered with ClinicalTrials.gov (NCT02428582) and is complete. Between April 6, 2015, and March 11, 2019, 158 eligible patients underwent mesenteric artery stenting procedures, of whom 94 patients (with 128 stents) provided consent and were included in the study. 47 patients (62 stents) were assigned to the covered stents group (median age 69·0 years [IQR 63·0-76·5], 28 [60%] female) and 47 patients (66 stents) were assigned to the bare-metal stents group (median age 70·0 years [63·5-76·5], 33 [70%] female). At 24 months, the primary patency of covered stents (42 [81%] of 52 stents) was superior to that of bare-metal stents (26 [49%] of 53; odds ratio [OR] 4·4 [95% CI 1·8-10·5]; p<0·0001). A procedure-related adverse event occurred in 17 (36%) of 47 patients in the covered stents group versus nine (19%) of 47 in the bare-metal stent group (OR 2·4 [95% CI 0·9-6·3]; p=0·065). Most adverse events were related to the access site, including haematoma (five [11%] in the covered stents group vs six [13%] in the bare-metal stents group), pseudoaneurysm (five [11%] vs two [4%]), radial artery thrombosis (one [2%] vs none), and intravascular closure device (none vs one [2%]). Six (13%) patients in the covered stent group versus one (2%) in the bare-metal stent group had procedure-related adverse events not related to the access site, including stent luxation (three [6%] vs none), major bleeding (two (4%) vs none), mesenteric artery perforation (one [2%] vs one [2%]), mesenteric artery dissection (one [2%] vs one [2%]), and death (one [2%] vs none). The findings of this trial support the use of covered stents for mesenteric artery stenting in patients with chronic mesenteric ischaemia. Atrium Maquet Getinge Group.

The characteristic of acute coronary syndromes of patients with multivessel coronary artery disease in centers with and without cardiac surgery on-site.

Multivessel disease (MVD) is diagnosed in a fair number of patients with acute coronary syndrome (ACS). There are 36 cardiac-surgery (CS) centres and 157 catheterization laboratories dedicated to treat ACS in Poland. The aim of the study was to analyze MVD patient outcomes presented with ACS in centers with or without CS on-site. The present study is a retrospective analysis (2017-2020) of MVD ACS patients (n = 4618) outcomes between those treated in centers with CS on site (n = 595) and those without CS (n = 4023). Patients in CS centers had a higher prevalence of renal failure (13.3% vs. 8.8%, p ≤ 0.001) and a more frequent history of coronary angioplasty - percutaneous coronary intervention (18.9% vs. 14.4%, p = 0.005). During the coronary angiography a femoral artery access was more often used in CS center patients (47.1% vs. 15.2%, p < 0.001). Percutaneous coronary intervention of MVD was more often performed in CS centers (74.6% vs. 71.0%, p = 0.054). In-hospital death (7.6% vs. 4.6%, p = 0.002), reinfarction (1.1% vs. 0.1%, p < 0.001), hemorrhagic complications (6.4% vs. 1.6%, p < 0.001), recurrent target vessel revascularization (1.8% vs. 0.4%, p ≤ 0.001) and pulmonary edema (3.7% vs. 1.5%, p < 0.001) occurred more often in CS centers. The safety of ACS treatment in MVD patients in centers without CS on site is non-inferior to their treatment in centers with CS on site. Interestingly, there were more in-hospital adverse events observed in ACS MVD patients treated in centers with CS.

Endovascular treatment of chronic ilio-femoral vein obstruction with extension below the inguinal ligament in patients with post-thrombotic syndrome

ObjectiveThis study aimed to evaluate postoperative outcomes of patients with chronic iliofemoral venous outflow obstruction and post-thrombotic syndrome (PTS) who underwent endovascular recanalization and stenting across the inguinal ligament. MethodsAll consecutive patients with chronic iliofemoral venous outflow obstruction and PTS were included in the analysis, from January 2018 and February 2022. Preoperative, intraoperative, and postoperative outcomes were assessed. Primary endpoints analyzed were major adverse events (MAEs) at 30 days and primary patency rate at 2 years of follow-up. Secondary endpoints assessed were secondary patency rate, target vessel revascularization, and clinical improvement evaluated with the Venous Clinical Severity Score (VCSS) classification, Villalta scale, and visual analog scale (VAS), respectively. ResultsA total of 63 patients (mean age, 48.1 ± 15.5 years; female, 61.9%) were evaluated. No intraoperative and 30-day postoperative complications were documented. The technical success rate was achieved at 100%. Overall, one in-stent occlusion and five in-stent restenosis were detected during follow-up. The primary patency rate was 93.7% (95% confidence interval [CI], 87.8%-99.9%) and 92.1% (95% CI, 85.6%-99%), at 1- and 2-year follow-up, respectively (Kaplan-Meier analysis). Target vessel revascularization was conducted in two cases, resulting in a secondary patency of 98.4% (95% CI, 95.4%-100%) at 2 years of follow-up. Stent fracture and/or migration were not observed during follow-up. A significant clinical improvement in the patient’s quality of life was documented. The median improvement of VCSS and Villalta scores were 4 (interquartile range, 2-7; P = .001), and 3 (interquartile range, 1.5-5; P = .001) vs baseline at the last follow-up. Overall, pain reduction of 17 mm on the VAS scale was documented at 2 years of follow-up. At multivariate analysis, presence of trabeculation into the femoral vein and deep femoral vein (odds ratio, 1.89; 95% CI, 0.15-6.11; P = .043), and Villalta scale >15 points at admission (odds ratio, 1.89; 95% CI, 0.15-6.11; P = .043) were predictive for in-stent occlusion during the follow-up. ConclusionsThe use of a dedicated venous stent across the inguinal ligament was safe and effective for the treatment of symptomatic iliofemoral venous disease with acceptable primary and secondary patency rates at 2 years of follow-up.

Management and outcomes of spontaneous coronary artery dissection: a systematic review of the literature.

Contemporary management of spontaneous coronary artery dissection (SCAD) is still controversial. This systematic review of the literature aims to explore outcomes in the patients treated with conservative management vs. invasive strategy. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed when we extensively searched three electronic databases: PubMed, ScienceDirect, and Web of Science, for studies that compared conservative vs. invasive revascularization treatment outcomes for patients with SCAD from 2003 to 2023. The outcomes of interest were all-cause death and major adverse cardiovascular events (MACE), including acute coronary syndrome (ACS), heart failure (HF), need for additional revascularization, target vessel revascularization (TVR), SCAD recurrence, and stroke. The systematic review included 13 observational studies evaluating 1,801 patients with SCAD. The overall mean age was 49.12 +/- 3.41, and 88% were females. The overall prevalence of arterial hypertension was 33.2%, hyperlipidemia, 26.9%, smoking, 17.8%, and diabetes, 3.9%. Approximately 48.5% of the patients were diagnosed with non-ST elevated myocardial infarction (NSTEMI), 36.8% with ST elevated myocardial infarction (STEMI), 3.41% with unstable angina, 0.56% with stable angina, and 0.11% were diagnosed with various types of arrhythmias. The left anterior descending artery (LAD) was the most common culprit lesion in 51% of the patients. There were initially 65.2% of conservatively treated patients vs. 33.4% that underwent percutaneous coronary intervention (PCI) or 1.28% that underwent coronary artery bypass graft (CABG). SCAD-PCI revascularization was associated with a variable range of PCI failure. The most common complications were hematoma extension and iatrogenic dissection. SCAD-PCI revascularization frequently required three or more stents and had residual areas of dissection. The overall reported in-hospital and follow-up mortality rates were 1.2% and 1.3%, respectively. The follow-up range across studies was 7.3-75.6 months. The authors reported variable prevalence of MACE, recurrent SCAD up to 31%, ACS up to 27.4%, TVR up to 30%, repeat revascularization up to 14.7%, UA up to 13.3%, HF up to 17.4%, and stroke up to 3%. Our results highlight that conservative treatment should be the preferred method of treatment in patients with SCAD. PCI revascularization is associated with a high prevalence of periprocedural complications. SCAD poses a considerable risk of MACE, mainly associated with TVR, ACS, and recurrent SCAD.

Intravascular Imaging-Guided Versus Angiography-Guided Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis of Randomized Trials.

Despite the initial evidence supporting the utility of intravascular imaging to guide percutaneous coronary intervention (PCI), adoption remains low. Recent new trial data have become available. An updated study-level meta-analysis comparing intravascular imaging to angiography to guide PCI was performed. This study aimed to evaluate the clinical outcomes of intravascular imaging-guided PCI compared with angiography-guided PCI. A random-effects meta-analysis was performed on the basis of the intention-to-treat principle. The primary outcomes were major adverse cardiac events, cardiac death, and all-cause death. Mixed-effects meta-regression was performed to investigate the impact of complex PCI on the primary outcomes. A total of 16 trials with 7814 patients were included. The weighted mean follow-up duration was 28.8 months. Intravascular imaging led to a lower risk of major adverse cardiac events (relative risk [RR], 0.67 [95% CI, 0.55-0.82]; P<0.001), cardiac death (RR, 0.49 [95% CI, 0.34-0.71]; P<0.001), stent thrombosis (RR, 0.63 [95% CI, 0.40-0.99]; P=0.046), target-lesion revascularization (RR, 0.67 [95% CI, 0.49-0.91]; P=0.01), and target-vessel revascularization (RR, 0.60 [95% CI, 0.45-0.80]; P<0.001). In complex lesion subsets, the point estimate for imaging-guided PCI compared with angiography-guided PCI for all-cause death was a RR of 0.75 (95% CI, 0.55-1.02; P=0.07). In patients undergoing PCI, intravascular imaging is associated with reductions in major adverse cardiac events, cardiac death, stent thrombosis, target-lesion revascularization, and target-vessel revascularization. The magnitude of benefit is large and consistent across all included studies. There may also be benefits in all-cause death, particularly in complex lesion subsets. These results support the use of intravascular imaging as standard of care and updates of clinical guidelines.

Echocardiography vs hemodynamic assessment of diastolic dysfunction.

Ostial CTOs can be challenging to revascularize. We aim to describe the outcomes of ostial chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We examined the clinical and angiographic characteristics and procedural outcomes of 8788 CTO PCIs performed at 35 US and non-US centers between 2012 and 2022. In-hospital major adverse cardiac events (MACE) included death, myocardial infarction, urgent repeat target-vessel revascularization, tamponade requiring pericardiocentesis or surgery, and stroke. Ostial CTOs constituted 12% of all CTOs. Patients with ostial CTOs had higher J-CTO score (2.9 ± 1.2 vs 2.3 ± 1.3; P less than .01). Ostial CTO PCI had lower technical (82% vs. 86%; P less than .01) and procedural (81% vs. 85%; P less than .01) success rates compared with non-ostial CTO PCI. Ostial location was not independently associated with technical success (OR 1.03, CI 95% 0.83-1.29 P =.73). Ostial CTO PCI had a trend towards higher incidence of MACE (2.6% vs. 1.8%; P =.06), driven by higher incidence of in-hospital death (0.9% vs 0.3% P less than.01) and stroke (0.5% vs 0.1% P less than .01). Ostial lesions required more often use of the retrograde approach (30% vs 9%; P less than .01). Ostial CTO PCI required longer procedure time (149 [103,204] vs 110 [72,160] min; P less than .01) and higher air kerma radiation dose (2.3 [1.3, 3.6] vs 2.0 [1.1, 3.5] Gray; P less than .01). Ostial CTOs are associated with higher lesion complexity and lower technical and procedural success rates. CTO PCI of ostial lesions is associated with frequent need for retrograde crossing, higher incidence of death and stroke, longer procedure time and higher radiation dose.

A more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: an Italian post-maRketing study (the CAESAR registry).

The use of contemporary drug-eluting stents (DES) has significantly improved outcomes of patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, concerns exist regarding the long-term proinflammatory effects of durable polymer coatings used in most DES, potentially leading to long-term adverse events. First-generation polymer-free stent technologies, such as sirolimus- and probucol-eluting stents (PF-SES), have shown an excellent safety and efficacy profile. The aim of this study was to evaluate the safety and efficacy of the new ultrathin Coroflex ISAR NEO PF-SES, in a more-comers PCI population. The CAESAR (a more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: An Italian post-maRketing study) registry is a multicenter, prospective study conducted in Italy, enrolling more-comers CAD patients undergoing PCI with the Coroflex ISAR NEO stent. Patients with left main (LM) disease, cardiogenic shock (CS), or severely reduced left-ventricular ejection fraction (LVEF) were excluded. The primary endpoint was target-lesion revascularization (TLR) at 1 year. A total of 425 patients were enrolled at 13 centers (mean age 66.9 ± 11.6 years, Diabetes mellitus 29%, acute coronary syndrome 67%, chronic total occlusion 9%). Of these, 40.9% had multivessel disease (MVD) and in 3.3% cases, the target lesion was in-stent restenosis (ISR). Clinical device success was reached in 422 (99.6%) cases. At 1 year, only two (0.5%) subjects presented ischemia-driven TLR. The 1-year rates of target vessel revascularization and MACE were 0.5% and 5.1%, respectively. Major bleeding was observed in four (1.0%) patients. In this multicenter, prospective registry, the use of a new ultrathin Coroflex ISAR NEO PF-SES in a more-comers PCI population showed good safety and efficacy at 1 year.

A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery

ObjectiveThe aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population. MethodsWe conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization at 12 months. Secondary endpoints included technical success, target vessel revascularization, major limb amputation, and all-cause mortality. Results are presented as survival probabilities based on Kaplan-Meier survival estimates. ResultsPatients (N = 300) were 58% male, with a mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication, and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Lesions were categorized as occlusions in 43% (mean occluded length, 16 ± 10 cm). TASC type was A (17%), B (29%), C (38%), and D (15%). Technical success was 99%. Re-stenting was performed in 5% and thrombolysis in 0.6% of patients. Kaplan-Meier estimates for freedom from target lesion revascularization were 90%, 72%, and 62% at 12, 24, and 36 months. Freedom from target vessel revascularization was 88%, 68%, and 59% and freedom from major target limb amputation was 99.6%, 98.9%, and 98.9%, respectively, at 12, 24, and 36 months. Survival was 95%, 89%, and 85% at 12, 24, and 36 months. ConclusionsThis post-market registry-based study shows promising results in treating femoral-popliteal ISR with paclitaxel DCB in comparison to the results of plain balloon angioplasty reported in the literature. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.

Prognostic impact of in-stent restenosis in normal weight, overweight, and obese patients undergoing percutaneous coronary intervention.

Amongpatients undergoing percutaneous coronary intervention (PCI), in-stent restenosis (ISR) is related with a worse prognosis, while higher body mass index (BMI) values are associated with better outcomes. It is unclear whether the prognostic impact of ISR varies in function of BMI. Patients undergoing PCI at a large center from 2012 to 2019 not presenting with an acute myocardial infarction (MI) were included. Subjects with BMI < 18.5 kg/m2 or treated with bare metal stents were excluded. Patients were stratified according to type of lesion treated (ISR vs. no-ISR) and into fourBMI categories: normal weight (BMI 18.5-25 kg/m2 ), overweight (25.0-29.9 kg/m2 ), class I obesity (30.0-34.9 kg/m2 ), class II-III obesity (≥35.0 kg/m2 ). The primary outcome was major adverse cardiovascular events (MACE), a composite of all-cause death, MI, and target vessel revascularization (TVR) at 1 year. Out of 16,234 patients, 3694 (23%) underwent PCI for ISR. ISR as compared to no-ISR was associated with a consistent increased risk of MACE within the normal weight (18.8% vs. 7.8%, adj.hazard ratio(HR):1.99, 95%confidence interval[CI]:1.51-2.64), overweight (19.1% vs. 6.4%, adj. HR:2.35, 95% CI: 1.91-2.88), class I obesity (18.3% vs. 6.8%, adj. HR: 1.95, 95% CI: 1.47-2.57), and class II-III obesity (16.4% vs. 7.4%, adj. HR: 1.61, 95% CI: 1.09-2.37) groups (interaction p-value: 0.192). The ISR-related risks were mostly driven by an excess of TVR. At 1 year, ISR was associated with an increased risk of MACE irrespective of BMI, mostly due to an excess of TVR after ISR.

Confounding Factors Responsible for Elevated Lp(a) Levels in Patients with Coronary Artery Disease.

Cardiovascular diseases (CVDs) are a leading cause of global mortality, motivating research into novel approaches for their management. Lipoprotein(a) (Lp(a)), a unique lipoprotein particle, has been implicated in atherosclerosis and thrombosis, suggesting its potential as a therapeutic target for CVDs. This study aimed to investigate the association of Lp(a) levels with various cardiovascular parameters and events among patients with confirmed cardiovascular disease. A prospective study was conducted, enrolling 600 participants, predominantly comprising males (79%), with a mean age of 52.78 ± 0.412 years diagnosed with cardiovascular disease. The follow-up was done for 18 months. Patient demographics, blood investigations, and occurrence of major adverse cardiac events (MACE) were collected. SPSS version 21 was used to statistically analyze the relationships between elevated Lp(a) levels and factors such as age, glycated hemoglobin, mortality, MACE, cardiac death, target vessel revascularization, and stroke. The study revealed significant (P < 0.05) associations between elevated Lp(a) levels and advanced age, increased glycated hemoglobin levels, as well as occurrences of all-cause mortality, MACE, cardiac death, target vessel revascularization, and stroke. Notably, a significant (P < 0.05), association between high Lp(a) levels and acute coronary syndrome (ACS) emerged, suggesting Lp(a)'s role in advanced cardiac events. The findings highlight the potential significance of Lp(a) as a notable risk factor in cardiovascular health. The observed associations between elevated Lp(a) and adverse cardiovascular events, including ACS, underscore its pathogenic role. Consequently, this study supports the rationale for further research into Lp(a)-specific therapeutic interventions, offering substantial promise in refining the management strategies for cardiovascular diseases.

Optimal timing of percutaneous coronary intervention in elderly patients with acute ST-segment elevation myocardial infarction presenting late.

Primary percutaneous coronary intervention (PPCI) is an effective method for the clinical treatment of acute ST-segment elevation myocardial infarction (STEMI). For patients who miss the optimal time window, optimal management of these patients remains controversial. To compare the effects of different timing of percutaneous coronary intervention on the long-term prognosis of elderly patients with acute ST-segment elevation myocardial infarction (STEMI) with time from symptom onset > 12 hours. Elderly acute STEMI patients with time from symptom onset > 12 hours in the period from July 2021 to July 2022 in the Department of Cardiology, Affiliated Hospital of Hebei University, were randomly divided into four groups: group 1 (immediate invasive strategy, percutaneous coronary interventions (PCI) < 24 hours after symptoms onset, n = 80), group 2 (early invasive strategy, 24-< 72 hours after symptoms onset, n = 80), group 3 (delayed invasive strategy after symptoms onset, 72-< 168 hours after symptoms onset, n = 80), and group 4 (late PCI group after symptoms onset, ≥ 168 hours after symptoms onset, n = 80). Primary study end points were 12-month cardiac mortality, nonfatal myocardial infarction (MI), target-vessel revascularization, and heart failure-related rehospitalization. There were no significant differences between groups in cardiac mortality, nonfatal MI and target-vessel revascularization. During follow-up, heart failure-related rehospitalization was higher in group 1 than in the other groups (18.8% vs. 5.1% vs. 7.4% vs. 6.3%, p = 0.010). Compared with group 1, group 2, group 3 and group 4 had lower heart failure-related rehospitalization (HR = 0.250, 95% CI: 0.083-0.753, p = 0.014) (HR = 0.377, 95% CI: 0.146-0.971, p = 0.043) (HR = 0.320, 95% CI: 0.116-0.879, p = 0.027). For acute STEMI patients who missed the optimal time of PCI, immediate PCI did not reduce adverse clinical outcomes.

Change in left ventricular function and outcomes following high-risk percutaneous coronary intervention with Impella-guided hemodynamic support.

High-risk percutaneous coronary interventions (HRPCI) are a potential treatment option for patients with reduced left ventricular ejection fraction (LVEF) and coronary artery disease. The extent to which such intervention is coupled with improvement in LVEF and associated with favorable outcomes is unknown. We aimed to characterize the incidence and correlates of LVEF improvement after Impella-guided HRPCI, and compare clinical outcomes in patients with versus without LVEF improvement. Data on consecutive patients undergoing Impella-guided HRPCI from a single center registry were analyzed. LVEF-improvement was defined as an absolute increase of LVEF of ≥10% measured at ≥30-days after intervention. The primary outcome was a composite of all-cause death, myocardial infarction or target vessel revascularization within 1-year. Out of 161 consecutive patients undergoing Impella-guided HRPCI from June 2008 to December 2017, 43% (n = 70) demonstrated LVEF-improvement (baseline LVEF of 25.09 ± 6.19 to 33.30 ± 11.98 post intervention). Patients without LVEF-improvement had higher frequency of previous MI (61.5% vs. 37.1%, p = 0.0021), Q-waves on ECG (17.6% vs. 5.7%, p = 0.024) and higher SYNTAX scores (30.8 ± 17.6 vs. 25.2 ± 12.2; p = 0.043). After correction of these confounders by multivariable analysis, no significant differences were found regarding the composite endpoint in patients with versus without LVEF-improvement (34.9% vs. 38.3%; p = 0.48). In this single-center retrospective analysis, we report the following findings. First, LVEF improvement of at least 10% was documented in over 40% of patients undergoing Impella supported high-risk PCI. Second, a history of MI, Q-waves on admission ECG, and higher baseline SYNTAX scores were independent correlates of no LVEF improvement. Third, one year rates of adverse CV events were substantial and did not vary by the presence or absence of LVEF improvement Prospective studies with longer follow-up are needed to elucidate the impact of LVEF improvement on clinical outcomes.