Chronic total occlusions (CTO) in coronary angiographies present a significant challenge nowadays. Intravascular ultrasound (IVUS) is a valuable tool during CTO-PCI, aiding in planning and achieving procedural success. However, the impact of IVUS on clinical and procedural outcomes in CTO-PCI remains uncertain. This meta-analysis aimed to compare IVUS-guided and angiography-guided approaches in CTO-PCI. The study included five studies and 2320 patients with stable coronary artery disease (CAD) and CTO. The primary outcome of major adverse cardiac events (MACE) did not significantly differ between the groups (p = 0.40). Stent thrombosis was the only secondary clinical outcome that showed a significant difference, favoring the IVUS-guided approach (p = 0.01). Procedural outcomes revealed that IVUS-guided procedures had longer stents, larger diameters, and longer procedure and fluoroscopy times (p = 0.007, p < 0.001, p = 0.03, p = 0.002, respectively). Stent number and contrast volume did not significantly differ between the approaches (p = 0.88 and p = 0.33, respectively). In summary, routine IVUS use did not significantly improve clinical outcomes, except for reducing stent thrombosis. Decisions in CTO-PCI should be individualized based on patient characteristics and supported by a multi-parametric approach.
Background conduction disturbances requiring permanent pacemaker (PPM) implantation are among the most common adverse events in patients undergoing transcatheter aortic valve replacement (TAVR). The introduction in clinical practice of a new generation of TAVR devices has contributed to a significant reduction in procedural complications. However, limited data is available regarding the usual timing of PPM implantation after TAVR with the latest available valves. Therefore, in this analysis, we aimed to investigate the incidence, risk factors, and timing of new permanent pacemakers after TAVR, with respect to the type of valve implanted. Methods Patients who underwent TAVR at our Institution from September 2008 to June 2022 were included in this analysis. Patients with previous PPM/ICD implantation or receiving only balloon angioplasty were excluded, as well as cases with procedural unsuccess. The independent association between baseline clinical and procedural variables and the occurrence of PPM implantation was investigated with cross-sectional logistic regression analysis. Results A total of 497 patients were included in the study, with a mean age of 80.4±5.6 years old; 59% were females, 37.2% of patients had diabetes, 60.2% had dyslipidemia, and 25.8% had chronic kidney disease. The mean left ventricular ejection fraction (LVEF) was 52.1%, and the mean Euroscore II was 7.7±5.1. The new generation of self-expandable valves was used in 280 (56.3%) patients, while the new generation of balloon-expandable devices was implanted in 118 (23.7%). After TAVR, 109 (21.3%) patients underwent PPM/ICD implantation after a mean time of 4.1±3.1 days. After adjustment, self-expandable devices, larger valve sizes (29 or 34 mm), and diabetes were significantly associated with PPM/ICD implantation. Of note, the new generation of valve devices was associated with a lower risk of PPM/ICD implantation. Conclusion The necessity for a permanent pacemaker is a well-known possible adverse effect after TAVR. In this analysis, we confirm the previous evidence of an increasing risk of PPM implantation with self-expandable compared to balloon-expandable devices. Interestingly, the new valve generation was associated with a lower risk of conduction disturbances requiring PPM implantation. Further analyses and investigations will be needed to assess the impact of developing interventional techniques and advanced technologies on the occurrence of conduction disturbances.
Background Transcatheter aortic valve replacement (TAVR), is the treatment of choice for most patients with aortic stenosis. Transfemoral access remains the most widely used peripheral vascular approach for TAVR and dedicated plug-based or suture-based vascular closure devices are available to achieve femoral hemostasis. However, the comparative safety of such strategies is controversial in patients undergoing transfemoral TAVR. Objectives in this study, we aimed to evaluate the rates of vascular access complications according to the use of plug-based or suture-based vascular closure in patients undergoing TAVR. Methods Data were retrospectively collected from two high-volume TAVR centers from September 2009 to March 2022. Patients were categorized according to the use of plug-based or suture-based vascular closure devices. The plug-based platform used was MANTA (Teleflex), while the suture-based devices were the Perclose ProGlide™ or the Prostar™ Systems (Abbott Vascular). Baseline demographic, clinical, and echocardiographic variables were compared between these groups using an independent-sample Student's t-test for continuous variables, presented as mean±SD, and the chi-square test for categorical or binary variables, presented as number and percentage, as appropriate. The odds ratio (OR) for vascular complications was calculated using a multivariate logistic regression model including as dependent variables all relevant baseline and procedural characteristics. The closure device variable was included in the multivariate model using the Prostar™ XL device group as reference. Vascular complications were adjudicated according to the Valve Academic Research Consortium definitions 3. Results Out of 874 patients, hemostasis was achieved with Prostar™ XL PVS in 120 (13.7%) patients, with Perclose ProGlide™ in 525 (60.1%), and with MANTA 229 (26.2%). No differences in age and common cardiovascular risk factors were observed between the group except for the prevalence of peripheral arterial disease (30.6% vs. 17.0%, p<0.0001) and dyslipidemia (58.9% vs. 68.6%, p=0.01) as well as for the echo and procedural variables except for the Euroscore II that was lower in the plug-based group (6.0±5.6 vs. 5.1±4.68), and for the higher use of new generation devices (79.1% vs. 98.3%, p<0.0001). After adjustment for common cardiovascular risk factors and procedural features, no differences were observed for total vascular complications [OR: 0.68 (95% confidence interval (CI): 0.33 to 1.38) and OR: 0.60 (95% CI: 0.33 to 1.53), for Perclose ProGlide™ and MANTA groups, respectively]. Likewise, no substantial differences were observed for major and minor vascular complications. Conclusions Both suture-based and plug-based devices have comparable outcomes with regard to the risk of vascular complications. Further randomized clinical trials are warranted to confirm this observation in high-risk sub-group patients with for example heavily calcified access or obesity.
Background The use of TAVR has been spreading out globally due to its favorable safety profile and the excellent efficacy data from randomized controlled trials. With the growing number of treated patients, the attention is rising around specific issues, such as the treatment of intercurrent coronary artery disease. Commissural alignment of transcatheter heart valves (THV) has the potential to reduce the impact of the prosthesis on accessibility of coronary ostia, as misalignment of the neo-commissures could be responsible for partial overlap with coronary artery ostia. However, no definitive evidence is available, despite multiple trials have addressed this issue. Methods The aim of this meta-analysis was to investigate the impact of the commissural alignment on coronary filling. We examined the techniques of commissural alignment and their impact on coronary access and coronary overlap. Eligible studies were searched for on Pubmed and SCOPUS and selected using the PRISMA guidelines. The primary endpoint is a composite of severe coronary overlap and failure of transcatheter coronary access. Odds Ratio were used as the metric for comparison between the groups. A random effects meta-analysis was selected as the calculation model. Results Six studies with a total of 1213 patients were included in this analysis. Of these patients, 757 patients underwent TAVR with commissural alignment and 456 underwent TAVR without commissural alignment. The composite endpoint of coronary overlap and failure of coronary access occurred in 118 patients undergoing TAVR with commissural alignment and in 124 patients without commissural alignment (OR=0.20, 95% CI 0.08-0.48; p= 0.0003). Conclusions Commissural alignment was associated with significantly lower rates of commissure-to-coronary-ostia overlap and failure of coronary access. Therefore, a modified insertion technique could reduce coronary overlap and coronary occlusion, particularly in supra-annular valves. Commissural alignment performed during TAVR could therefore have an important role in coronary re-access and re-intervention especially in younger patients.
Introduction although transcatheter aortic valve replacement (TAVR) represents a milestone in the treatment of degenerative aortic stenosis, stroke remains an important complication compared to surgical aortic valve replacement (SAVR). Multiple magnetic resonance imaging (MRI) studies demonstrated a substantial rate of new cerebral ischemic lesions after TAVR. In order to avoid debris passage into the circulation and to prevent procedure-related embolic stroke, cerebral embolic protection (CEP) devices were developed. However, their safety and efficacy remain controversial. Very recently, new studies provided additional evidence on this topic. Aim to assess the entire body of evidence from randomized controlled studies about neurological outcomes after TAVR. Materials and Methods a systematic meta-analysis was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched MEDLINE, Scopus, and Google Scholar for randomized controlled studies. The following keywords were used for the search: “transcatheter aortic valve implantation” or “stroke prevention” or “embolic protection” and “cerebral protection”. Study groups were defined as a the “CEP group” and the “control group”. Non-randomized studies reporting outcomes with cerebral embolic protection (CEP) during TAVR were excluded to reduce the selection and confounding bias of observational pilot studies. The primary outcome was post-procedural stroke. Secondary outcomes included total lesion volume on MRI and new ischemic lesions on MRI. Results nine trials including 4077 patients were eligible for analysis and included to the meta-analysis. Of those, 2203 patients were randomized to cerebral embolic protection and 1874 patients to control group. Despite the rate of post-procedural stroke was higher in the CEP arm (2.27%) compared to the control arm (2.87%, p<0.001), the use of cerebral embolic protection was not associated with a significantly lower risk of stroke (OR=0.82, 95% CI 0.59-1.15; p=0.255). Cumulative meta-analysis revealed a trend towards a lower impact on stroke prevention with more recent trials. Conclusions use of cerebral embolic protection devices during TAVR is a safe procedure. However, the current outline of results from all randomized controlled trials available does not support its routine use, as no significant reduction of stroke risk was evident. The use of these devices might be considered in selected high-risk patients, such as in the setting of heavy calcified cusps or atherosclerotic aortic lesions.
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