The Unforgettable Cornerstone Colombo, Antonio, MD; Ancona, Marco B., MD; Chieffo, Alaide, MD
Journal of the American College of Cardiology,
02/2017, Volume:
69, Issue:
6
Journal Article
Background
Bifurcation percutaneous coronary intervention (PCI) is a challenging procedure, but there are currently inadequate data about definite stent thrombosis (ST) rates of single‐stent versus ...double‐stent strategies (SS and DS, respectively).
Methods and results
Randomized clinical trials (RCTs) comparing SS and DS strategies were searched through PubMed, Embase, and the Cochrane Central Register of Controlled Trials. Fourteen RCTs involving 3,107 patients were analyzed. Owing to the high crossover rate (16.49%), both intention‐to‐treat (ITT) and as‐treated (AT) analyses were performed. In the ITT population, there was a significantly lower rate of early definite ST in the SS group (0.26%; DS group 1.14%; P = 0.021). Similarly, in the AT population, there was a significantly lower rate of early definite ST in the SS group (0.23%, DS group 1.07%; P = 0.042). True bifurcation subgroup analysis also showed a significantly lower early definite ST in the SS group (OR = 0.36, 95% CI = 0.15–0.86, P = 0.042) in the ITT population. There was no significant difference of overall, acute, subacute, and late definite ST between the 2 groups.
Conclusions
Early definite ST is reduced when a SS strategy is used in bifurcation lesions.
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;
<0.001), cardiac death (RR, 0.49 95% CI, 0.34-0.71;
<0.001), stent thrombosis (RR, 0.63 95% CI, 0.40-0.99;
=0.046), target-lesion revascularization (RR, 0.67 95% CI, 0.49-0.91;
=0.01), and target-vessel revascularization (RR, 0.60 95% CI, 0.45-0.80;
<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;
=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.
Background
The prevalence of both chronic kidney disease (CKD) and aortic stenosis (AS) increase with age. Although baseline CKD is frequent in patients undergoing transcatheter aortic valve ...replacement (TAVR), its significance among women is largely unknown.
Methods
Women's INternational Transcatheter Aortic Valve Implantation (WIN‐TAVI) is a multinational, prospective registry of women undergoing TAVR for severe AS. We included patients with available baseline estimated glomerular filtration rate (eGFR) and completed 1‐year follow‐up. Patients were categorized into three groups based on their eGFR: No CKD (normal kidney function to stage 2 CKD: eGFR ≥60 ml/min/1.73 m2); (b) mild CKD (stage 3a CKD: eGFR = 45–59 ml/min/1.73 m2); and (c) moderate/severe CKD (stage ≥3b CKD: eGFR <45 ml/min/1.73 m2). All events were adjudicated according to the Valve Academic Research Consortium (VARC)‐2 criteria.
Result
Out of 852 women undergoing TAVR, 326 (38.3%) had no CKD, 225 (26.4%) had mild CKD, and 301 (35.3%) had moderate/severe CKD. Women with higher stage of CKD at baseline were more likely to have a history of hypertension, diabetes, atrial fibrillation, anemia, chronic lung disease, hemodialysis, prior percutaneous coronary intervention, and pacemaker implantation. After multivariate adjustment, moderate/severe CKD was associated with a greater risk of 1‐year VARC‐2 safety endpoints hazard ratio (HR) 1.68, 95% confidence interval (CI): 1.10–2.60, all‐cause death (HR 2.00, 95% CI: 1.03–3.90), and composite of death, myocardial infarction, stroke or life‐threatening bleeding (HR 1.70, 95% CI: 1.04–2.76). There were no differences in 30‐day and 1‐year VARC‐2 efficacy and 30‐day VARC‐2 safety outcomes.
Conclusion
CKD is associated with substantial and independent risk for mortality and morbidity at 1‐year follow‐up in women undergoing TAVR.
Abstract Objectives This study aimed to investigate the clinical outcomes of patients presenting with recurrent drug-eluting stent (DES) in-stent restenosis (ISR) treated with a second-generation DES ...or with a drug-coated balloon (DCB). Background To date, there are no reports of DCB treatment and limited data with regard to the efficacy of further DES implantation for recurrent ISR. Methods Between January 2008 and December 2013, 171 lesions were assessed for eligibility (82 lesions in the second-generation DES group and 89 lesions in the DCB group). Results Acute gain was greater in the second-generation DES group (second-generation DES, 2.09 ± 0.53 mm vs. DCBs, 1.60 ± 0.62 mm, p < 0.001). The rates of major adverse cardiac events were comparable (at 1 year, DES 14.0% vs. DCBs 12.3%; at 2 years, DES 28.8% vs. DCBs 43.5%, p = 0.21). Major adverse cardiac event rates were mainly driven by target lesion revascularization (at 1 year, DES 12.5% vs. DCBs 10.9%; at 2 years, DES 27.7% vs. DCBs 38.3%; p = 0.40). Definite scaffold thrombosis occurred in 2 patients (1 patient in each group). Multivariable analysis revealed ISR recurrence within 1 year (hazard ratio: 2.43, 95% confidence interval: 1.14 to 5.18, p = 0.02) and lesion length (per 10-mm increase) (hazard ratio: 1.15, 95% confidence interval: 1.00 to 1.32, p = 0.049) to be independent predictors of TLR. Conclusions The results after both treatments were equivalent. ISR recurrence within 1 year of the first reintervention and lesion length were independent predictors of future target lesion revascularization. Larger studies are required to confirm the late (>1 year) differences with regard to clinical outcomes.
There are no direct comparisons between transapical aortic valve implantation (TA-AVI) and transfemoral aortic valve implantation (TF-AVI). Therefore, the aim of this study was to compare the ...short-term and midterm outcomes of TA-AVI versus TF-AVI.
Data from four European centers were pooled and analyzed. To minimize differences between TA-AVI and TF-AVI multivariable analysis was used. Study endpoints were defined according to the Valve Academic Research Consortium-I criteria at 30 days and 1 year. Primary endpoints of this study were 30-day all-cause mortality and mortality during follow-up.
A total of 882 patients underwent TAVI, of whom 793 (89.9%) underwent TF-AVI and 89 (10.1%) underwent TA-AVI. Patients undergoing TA-AVI had a higher estimated risk of mortality as defined by the logistic European System for Cardiac Operative Risk Evaluation score (median 27.0, interquartile range IQR: 20.2 to 33.8 versus median 20.0, IQR: 12.3 to 27.7; p < 0.001) and The Society of Thoracic Surgeons Score (median 10.2, IQR: 5.3 to 9.9 versus median 6.7, IQR: 3.5 to 9.9; p < 0.001) and had more comorbidities. At 30 days, there was an increased risk of all-cause mortality in the TA-AVI group (odds ratio OR 3.12, 95% confidence interval CI: 1.43 to 6.82; p = 0.004). TF-AVI was associated with a higher frequency of major (OR 0.33, 95% CI: 0.12 to 0.90; p = 0.031) and minor vascular complications (OR 0.17, 95% CI: 0.04 to 0.71; p = 0.0015). In-hospital stay was significantly longer among patients undergoing TA-AVI (OR 2.29, 95% CI: 1.28 to 4.09; p = 0.05). During a median follow-up of 365 days (IQR: 174 to 557), TA-AVI was associated with an increased risk of all-cause mortality (hazard ratio 1.88, 95% CI: 1.23 to 2.87; p = 0.004).
In institutions performing a low volume of TA-AVI, the technique is associated with an increased risk of all-cause mortality and longer hospital stay but less vascular complications in comparison with TF-AVI. The interaction between experience and type of treatment on outcome requires further investigation before advocating one treatment over the other.
Abstract The cardiac catheterization laboratory is an important source of radiation for patients and operators and it is good practice to limit exposure as much as possible. The purpose of this study ...was to evaluate the effectiveness and impact of a radiological Low Dose Protocol (LDP) in terms of reduction in patient radiation exposure during percutaneous coronary interventions (PCI). Between November 2014 and October 2015, 906 consecutive patients who underwent PCI were evaluated. Of these, 571 patients (63%) were treated with the Standard Dose Protocol (SDP) of 15 frames per second (fps) for cine acquisition and standard settings for fluoroscopy, and 335 patients (37%) with the LDP of 7.5 fps for cine acquisition and low dose settings for fluoroscopy. In the LDP group, we observed a significant reduction of Kerma Area Product (53.3 LDP vs 115 SDP Gycm2 , p<0.0001 and Air Kerma at Interventional Reference Point (AK at IRP) (0.79 LDP vs 1.976 SDP Gy, p<0.0001). Marked differences were observed regarding the exceeding of International Commission on Radiological Protection and National Council on Radiation Protection and Measurements’ AK at IRP trigger level (cut-off for potential skin injuries), which were significantly lower in the LDP group (1.8 vs 7.2 %, p<0.0001). Such difference was more relevant in complex PCI. In conclusion, the implementation of LDP allowed a marked reduction in patient dosimetric parameters for PCI and significantly reduced the risk of exceeding the ICRP/NCRP trigger levels for potential skin injuries.
Background Women represent an increasing percentage of interventional cardiologists in Italy compared with other countries. However, gaps exist in understanding and adapting to the impact of these ...changing demographics. Methods and Results We performed a national survey to analyze demographics, gender-based professional difference, needs in terms of catheterization laboratory (Cath-Lab) abstention, and radiation safety issues in Italian Cath-Lab settings. A survey supported by the Italian Society of Interventional Cardiology (Società Italiana di Cardiologia Interventistica-Gruppo Italiano di Studi Emodinamici SICI-GISE) was mailed to all SICI-GISE members. Categorical data were compared using the χ
test.
<0.05 was considered significant. There were 326 respondents: 20.2% were <35 years old, and 64.4% had >10 years of Cath-Lab experience. Notably, 26.4% were women. Workload was not gender-influenced (women performed "on-call" duty 69.8% versus men 68.3%;
=0.97). Women were more frequently unmarried (22.1% women versus 8.7% men;
=0.002) and childless (43.9% versus 56.1%;
<0.001). Interestingly, 69.8% of women versus 44.6% of men (
<0.001) argued that pregnancy/breastfeeding negatively impacts professional skill development and career advancement. For Cath-Lab abstention, 38.9% and 69.6% of respondents considered it useful to perform percutaneous coronary intervention robotic simulations and "refresh-skill" sessions while they were absent or on return to work, respectively, without gender differences. Overall, 80% of respondents described current radioprotection counseling efforts as inadequate and not gender specific. Finally, 26.7% faced some type of job discrimination, a significantly higher proportion of whom were women. Conclusions Several gender-based differences exist or are perceived to exist among interventional cardiologists in Italian Cath-Labs. Joint strategies addressing Cath-Lab abstention and radiation exposure education should be developed to promote gender equity in interventional cardiologists.
Abstract The use of bioresorbable scaffolds (BRS) may be associated with benefits including restoration of endothelial function, positive vessel remodeling, and reduced risk for very late (stent) ...thrombosis compared with metallic stents by virtue of their complete absorption within 3 to 4 years of implantation. When treating bifurcation lesions, these advantages may be even more pronounced. The aim of this review is to summarize current experiences and technical considerations of bifurcation treatment with BRS. Because of the physical properties of current-generation BRS, there are concerns with regard to the efficacy and safety of this novel technology for the treatment of bifurcations, with the potential for increased rates of scaffold thrombosis and side-branch occlusions, and as a consequence, bifurcations have been excluded from the major BRS trials. Nevertheless, BRS have been used for this indication in clinical practice, as evidenced by “real-world” registries. Considering the potential limitations, specific technical considerations and modified bifurcation strategies should be used in an attempt to attenuate problems and achieve optimal procedural and clinical outcomes.
High-risk PCI: one device cannot fix it all Chieffo, Alaide; Iannaccone, Mario
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,
01/2024, Volume:
20, Issue:
2
Journal Article
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