Sergio Buccheri

Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation

BACKGROUND The majority of transcatheter aortic valve implantation (TAVI) procedures are currently performed by percutaneous transfemoral approach. The potential contribution of the type of vascular closure device to the incidence of vascular complications is not clear. AIM To compare the efficacy of a Prostar XL- vs. Perclose ProGlide-based vascular closure strategy. METHODS The ClOsure device iN TRansfemoral aOrtic vaLve implantation (CONTROL) multi-center study included 3138 consecutive percutaneous transfemoral TAVI patients, categorized according to vascular closure strategy: Prostar XL- (Prostar group) vs. Perclose ProGlide-based vascular closure strategy (ProGlide group). Propensity-score matching was used to assemble a cohort of patients with similar baseline characteristics. RESULTS Propensity matching identified 944 well-matched patients (472 patient pairs). Composite primary end point of major vascular complications or in-hospital mortality occurred more frequently in Prostar group when compared with ProGlide group (9.5 vs. 5.1%, P = 0.016), and was driven by higher rates of major vascular complication (7.4 vs. 1.9%, P < 0.001) in the Prostar group. However, in-hospital mortality was similar between groups (4.9 vs. 3.5%, P = 0.2). Femoral artery stenosis occurred less frequently in the Prostar group (3.4 vs. 0.5%, P = 0.004), but overall, Prostar use was associated with higher rates of major bleeding (16.7 vs. 3.2%, P < 0.001), acute kidney injury (17.6 vs. 4.4%, P < 0.001) and with longer hospital stay (median 6 vs. 5 days, P = 0.007). CONCLUSIONS Prostar XL-based vascular closure in transfemoral TAVI procedures is associated with higher major vascular complication rates when compared with ProGlide; however, in-hospital mortality is similar with both devices.

Transcatheter aortic valve replacement with new-generation devices: A systematic review and meta-analysis

OBJECTIVE The aim of this study was to conduct a weighted meta-analysis to determine the rates of acute (≤30days) major outcomes after (TAVR) with second-generation devices. METHODS A comprehensive search of multiple electronic databases from January 2011 to May 2017 was conducted using predefined criteria. New-generation TAVR devices were defined as any device which received CE mark approval or is still under evaluation for CE marking after CoreValve and SAPIEN XT prostheses. RESULTS A total of 37 studies including 10,822 patients met inclusion criteria and were included in the analysis. Devices investigated in the studies were the following: SAPIEN 3 (n=5423, 45.9%), Lotus Valve (n=3007, %), Portico (n=130, 1.1%), JenaValve (n=345, 2.9%), Symetis Acurate (n=1314, 11,1%), and Evolut R (n=1603, 13.6%). Thirty-day all-cause and cardiovascular 30-day death were 2.2% (95% CI: 1.6% to 2.8%) and 1.6% (95% CI: 0.9% to 2.3%), respectively; Any stroke and major/disabling stroke occurred at a pooled estimate rate of 2.6% (95% CI: 2.0% to 3.3%) and 0.9% (95% CI: 0.2% to 1.6%), respectively; life-threatening bleeding, 3.9% (95% CI: 2.9% to 5.0%); major vascular complications, 4.5% (95% CI: 3.7% to 5.4%); pacemaker implantation, 16.2% (95% CI: 12.7% to 19.6%); more than mild aortic regurgitation, 1.6% (95% CI: 0.9 to 2.3). CONCLUSIONS Second-generation TAVR devices are associated with very low mortality and major complications rates at 30-day, and improved prosthesis performance with <2% of patients having more than mild post-procedural aortic regurgitation. On the other hand, the need for pacemaker implantation seems to remain an unresolved issue, and warrants further investigation.

Optimized Screening of Coronary Artery Disease With Invasive Coronary Angiography and Ad Hoc Percutaneous Coronary Intervention During Transcatheter Aortic Valve Replacement

Background— We sought to describe an optimized approach to coronary artery disease (CAD) screening and management in patients undergoing transcatheter aortic valve replacement (TAVR). Methods and Results— When invasive coronary angiography showed CAD, the treatment strategy and completeness of revascularization was determined based on coronary anatomy. TAVR was performed in the same setting if percutaneous coronary intervention (PCI) was uncomplicated; otherwise TAVR was postponed. A total of 604 patients undergoing CAD screening at the time of TAVR procedure were prospectively included in this study. Severe CAD was found in 136 patients (22.5%). Among patients with severe CAD, 53 patients (8.8%) underwent uncomplicated PCI. After PCI, TAVR was postponed in 2 patients (0.3%). In 83 patients (13.8%), coronary angiography showed severe CAD that was left untreated. After TAVR, all-cause and cardiovascular 30-day mortality rates were 2.4% and 1.4%, respectively. Disabling stroke, myocardial infarction, and life-threatening bleeding occurred in 0.5%, 0.8%, and 4.0% of patients, respectively. Acute kidney injury II or III rate was 3.3%. At 2 years, all-cause mortality rate was 14.1%. Disabling stroke and myocardial infarction occurred in 2.5% and 1.8% of patients, respectively. Patients undergoing TAVR and PCI in the same session had similar rate of the composite of death, disabling stroke, and myocardial infarction when compared with patients without CAD, and patients with severe CAD left untreated (TAVR+PCI: 10.4%; severe CAD left untreated: 15.4%; no-CAD: 14.8%; P=0.765). Conclusions— In patients undergoing TAVR, screening of CAD with invasive coronary angiography and ad hoc PCI during TAVR is feasible and was not associated with increased periprocedural risks. PCI followed by TAVR in the same session had similar outcomes than TAVR in which PCI was not performed.

Preventive Strategies for Contrast-Induced Acute Kidney Injury in Patients Undergoing Percutaneous Coronary Procedures: Evidence From a Hierarchical Bayesian Network Meta-Analysis of 124 Trials and 28 240 Patients

Background— The effectiveness of currently available effective preventive strategies for contrast-induced acute kidney injury (CIAKI) is a matter of debate. Methods and Results— We performed a Bayesian random-effects network meta-analysis of 124 trials (28 240 patients) comparing a total of 10 strategies: saline, statin, N-acetylcysteine (NAC), sodium bicarbonate (NaHCO3), NAC+NaHCO3, ascorbic acid, xanthine, dopaminergic agent, peripheral ischemic preconditioning, and natriuretic peptide. Compared with saline, the risk of CIAKI was reduced by using statin (odds ratio [OR], 0.42; 95% credible interval [CrI], 0.26–0.67), xanthine (OR, 0.32; 95% CrI, 0.17–0.57), ischemic preconditioning (OR, 0.48; 95% CrI, 0.26–0.87), NAC+NaHCO3 (OR, 0.50; 95% CrI, 0.33–0.76), NAC (OR, 0.68; 95% CrI, 0.55–0.84), and NaHCO3 (OR, 0.66; 95% CrI, 0.47–0.90). The benefit of statin therapy was consistent across multiple sensitivity analyses, whereas the efficacy of all the other strategies was questioned by restricting the analysis to high-quality trials. Overall, high heterogeneity was observed for comparisons involving xanthine and ischemic preconditioning, although the impact of NAC and xanthine was probably influenced by publication bias/small-study effect. Hydration alone was the least effective preventive strategy for CIAKI. Meta-regressions did not reveal significant associations with baseline creatinine and contrast volume. In patients with diabetes mellitus, no strategy was found to reduce the incidence of CIAKI. Conclusions— In patients undergoing percutaneous coronary procedures, statin administration is associated with a marked and consistent reduction in the risk of CIAKI compared with saline. Although xanthine, NAC, NaHCO3, NAC+NaHCO3, ischemic preconditioning, and natriuretic peptide may have nephroprotective effects, these results were not consistent across multiple sensitivity analyses.

Feasibility, Reproducibility, and Agreement between Different Speckle Tracking Echocardiographic Techniques for the Assessment of Longitudinal Deformation

Background. Left ventricular (LV) longitudinal deformation can be assessed with new echocardiographic techniques like triplane echocardiography (3PE) and four-dimensional echocardiography (4DE). We aimed to assess the feasibility, reproducibility, and agreement between these different speckle-tracking techniques for the assessment of longitudinal deformation. Methods. 101 consecutive subjects underwent echocardiographic examination. 2D cine loops from the apical views, a triplane view, and an LV 4D full volume were acquired in all subjects. LV longitudinal strain was obtained for each imaging modality. Results. 2DE analysis of LV strain was feasible in 90/101 subjects, 3PE strain in 89/101, and 4DE strain in 90/101. The mean value of 2DE and 3PE longitudinal strains was significantly higher with respect to 4DE. The relationship between 2DE and 3PE derived strains (r = 0.782) was significantly higher (z = 3.72, P < 0.001) than that between 2DE and 4DE (r = 0.429) and that between 3PE and 4DE (r = 0.510; z = 3.09, P = 0.001). The mean bias between 2DE and 4DE strains was −6.61 ± 7.31% while −6.42 ± 6.81% between 3PE and 4DE strains; the bias between 2DE and 3PE strain was of 0.21 ± 4.16%. Intraobserver and interobserver variabilities were acceptable among the techniques. Conclusions. Echocardiographic techniques for the assessment of longitudinal deformation are not interchangeable, and further studies are needed to assess specific reference values.

Reference Values for Real Time Three-Dimensional Echocardiography–Derived Left Ventricular Volumes and Ejection Fraction: Review and Meta-Analysis of Currently Available Studies

Current guidelines recommend three‐dimensional echocardiography (3DE) as the reference technique to assess left ventricular (LV) volumes and ejection fraction (EF). We performed a meta‐analysis to identify normative reference values by real time 3DE in healthy subjects.

Procedural Management of Patients With Advanced Heart Failure Undergoing MitraClip Implantation (From the GRASP Registry).

Cite this article as: Sergio Buccheri, Marco Barbanti, Davide Capodanno, Antonio Popolo Rubbio, Piera Capranzano, Umberto Scaglione, Giuseppe Giuliano, Salvatore Scandura, Sarah Mangiafico, Sebastiano Immé, Silvia Farruggio, Sandra Giaquinta, Carmelo Grasso and Corrado Tamburino, Procedural management of patients with advanced heart failure undergoing MitraClip implantation (from the GRASP registry), Journal of Cardiothoracic and Vascular Anesthesia, http://dx.doi.org/10.1053/j.jvca.2016.09.013

Strategies and Outcomes of Repeat Mitral Valve Interventions after Failed MitraClip Therapy.

Percutaneous mitral valve repair (PMVR) with the MitraClip system (Abbott Vascular, Santa Clara, CA, USA) is a valid therapeutic option for patients with severe mitral regurgitation (MR) deemed to be at high or prohibitive surgical risk. Despite the reassuring data on efficacy and long-term durability of the procedure, the proportion of patients with residual or relapsing severe MR after MitraClip therapy is not negligible. In light of the detrimental prognostic impact of severe MR, repeat interventions are increasingly performed in clinical practice using different techniques. In high-risk settings, percutaneous procedures have proven to be effective and safe at reducing MR. Building on this, we sought to summarize the current landscape and clinical experience of reinterventions after failed MitraClip therapy, so as to assist physicians facing the clinical hurdle of proper treatment management after failed PMVR.

Chemotherapy-induced cardiotoxicity: Subclinical cardiac dysfunction evidence using speckle tracking echocardiography

Objectives: In our study, we aimed to identify early markers of cardiac dysfunction in patients treated with mitoxantrone. We also looked at cardiac functional changes during therapy by analyzing longitudinal deformation and by measuring left ventricular (LV) and left atrial (LA) global strain. Materials and Methods: LA and LV global longitudinal strain were analyzed in 20 patients affected by multiple sclerosis and treated with mitoxantrone. Patients underwent echocardiography before treatment, after every drug administration during the 12-months treatment period, and finally after 6 and 12 months of drug discontinuation. Results: Compared with baseline values, patients showed a significant reduction of both LA and LV longitudinal global strain at the end of treatment with mitoxantrone (LA_GS% T10 vs. T0 values: 15,2 ± 12,5 vs. 20,2 ± 11,1; LV_GS%: ─16,4 ± 2,5 vs. ─17,4 ± 3,8). Strain reduction reverted after treatment discontinuation (LA_GS% FU vs. T0 values: 20,4 ± 15,7 vs. 20,2 ± 11,1; LV_GS%: ─17,3 ± 3,3 vs. ─17,4 ± 3,8). Conclusions: Impairment of longitudinal deformation during mitoxantrone therapy may indicate a dysfunction related to early myocardial damage. These findings appear to be reversible after treatment discontinuation.

Operator volume and mortality in percutaneous coronary intervention: a call for better competency metrics

In manual disciplines, increasing levels of practice are expected to parallel the individual’s ability to perform a specific action or technique. In the field of interventional cardiology, a skilled operator is able to optimize all the steps of percutaneous coronary intervention (PCI), from vascular access to stent implantation, while reducing the total amount of contrast dye administered and procedural time. On top of sound clinical judgment, these factors may translate into a better prognosis. Improved outcomes with proficient operators are even more obvious in complex anatomical (e.g. left main disease or chronic total occlusions) and clinical (e.g. primary PCI or cardiogenic shock) settings, or at the time of managing procedural complications (e.g. perforations, dissections, or bleeding). Based on European guidelines for myocardial revascularization, interventional cardiologists are considered independent operators if they have personally performed at least 200 PCI procedures under the guidance of a supervisor, including a third of cases performed in the setting of an emergency or an acute coronary syndrome (ACS). Maintaining proficiency in interventional cardiology also requires a certain volume of procedures performed per year, e.g. at least 75 PCIs in the context of an ACS or at least 75 PCIs in the context of stable coronary artery disease. All these recommendations are class IIa, indicating conflicting evidence and/or a divergence of opinion about the true impact of practice volumes on the early prognosis of PCI (the so-called ‘volume–outcome relationship’). A study of more than 3 million procedures from the National Cardiovascular Data Registry CathPCI registry, which collects detailed information on >90% of PCIs performed in the USA, recently suggested an inverse relationship between operator volume and in-hospital mortality that persisted in risk-adjusted analyses. In this issue of the European Heart Journal, Hulme et al. add to the debate on the volume–outcome relationship with conflicting findings from the UK’s perspective. Using data from 133 970 PCI procedures performed by 540 interventional cardiologists in England and Wales, the authors did not find a significant relationship between 30-day mortality and operator volume (defined as the total number of procedures the operator was responsible for in the previous 12 months) after accounting for operatorand center-level effects and adjusting for case-mix and potential confounders. This finding, which was consistent across subgroups of patients presenting with ACS or undergoing primary PCI, and in a sensitivity analysis using in-hospital mortality as the outcome measure, applies to a quite contemporary (2013–14) scenario where radial access was the dominant strategy, most patients had an ACS, 30-day mortality was 2.6%, the median volume across all procedures was as high as 178 per year, and only 5% of procedures were performed by low-volume operators. These figures should be considered when generalizing the study findings outside the boundaries of the UK, where many countries have lower operator volumes. To put these results in perspective, for example, the proportion of operators who performed <50 PCI procedures per year was only 14% in this study vs. 44% in the CathPCI registry. Compared with previous studies addressing the volume–outcome relationship in PCI, this report has several strengths. First, the definition of operator volume was based on a rolling measure that allowed the updating of operator volume every month instead of using the calendar year as a reference value. Through one year (i.e. from January to December), this approach overcomes the caveat of considering the total number of PCI procedures performed up to December (i.e. a future calendar date) when assessing 30-day mortality in January. Second, the British Cardiovascular Intervention Society registry is one of the few platforms in Europe offering complete national coverage of all consecutive patients undergoing PCI with subsequent administrative linkage to mortality outcomes. Third, the authors must be congratulated for proficiently undertaking complex