Matteo Pagnesi

Clinical outcomes of a real-world cohort following bioresorbable vascular scaffold implantation utilising an optimised implantation strategy.

AIMS It has become apparent that, in comparison to metallic stents, bioresorbable vascular scaffolds (BVS) require specific implantation techniques. The aim of this study was to investigate outcomes following BVS implantation using a dedicated strategy for optimal deployment. METHODS AND RESULTS Four hundred consecutive lesions (264 patients) treated with the Absorb BVS were analysed. All procedures were performed based on the following principles: 1) aggressive lesion preparation; 2) high-pressure post-dilation; and 3) a low threshold for intravascular imaging. The majority of target lesions (74.8%) were type B2 or C lesions. Predilation (97.3%) and post-dilation (99.8%) were performed in almost all cases. The mean post-dilation pressure was 21±5 atm, and the total scaffold length per patient was 53.2±32.5 mm. Intravascular imaging was performed in the majority of cases (85.8%) and, when utilised after post-dilatation, a further intervention was required in 24.5% of lesions. The cumulative target lesion failure rates were 7.9% at one year and 11.6% at two years. Definite/probable scaffold thrombosis occurred in three patients (1.2% at one and two years). CONCLUSIONS Clinical outcomes following implantation of current-generation BVS, in a real-world population with a high prevalence of complex lesions, were acceptable when utilising our optimised implantation strategy.

Silent cerebral injury after transcatheter aortic valve implantation and the preventive role of embolic protection devices: A systematic review and meta-analysis

BACKGROUND The aims of this study were: 1) to evaluate silent cerebral injury detected by cerebral diffusion weighted magnetic resonance imaging (DW-MRI) after transcatheter aortic valve implantation (TAVI); and 2) to assess the efficacy of embolic protection devices (EPDs) on DW-MRI endpoints. METHODS We included in a pooled analysis 25 prospective studies reporting post-procedural cerebral DW-MRI data after TAVI (n=1225). Among these studies, we included in a meta-analysis 6 studies investigating TAVI performed with versus without EPDs (n=384). Primary endpoints were the number of new lesions per patient and the total lesion volume, while secondary endpoints were the number of patients with new lesions and the single lesion volume. RESULTS The main pooled DW-MRI outcomes were: patients with new ischemic lesions, 77.5% (95% confidence interval=71.7-83.3%); total lesion volume, 437.5mm(3) (286.7-588.3mm(3)); single lesion volume, 78.1mm(3) (56.7-99.5mm(3)); and number of new lesions per patient, 4.2 (3.4-5.0). The use of EPDs was associated with a significant reduction in total lesion volume (mean difference [95% confidence interval]=-111.1mm(3) [-203.6 to -18.6mm(3)]; p=0.02) and single lesion volume (-12.1mm(3) [-18.3 to -6.0mm(3)]; p=0.0001) after TAVI. CONCLUSIONS Silent cerebral injury occurs in the majority of patients undergoing TAVI and DW-MRI allows a precise characterization of new ischemic brain lesions. EPDs reduce the total and single volume of such lesions detected after the procedure, although the number of new lesions per patient and the number of patients with new lesions are not significantly reduced by such devices.

Tricuspid annuloplasty versus a conservative approach in patients with functional tricuspid regurgitation undergoing left-sided heart valve surgery: A study-level meta-analysis

BACKGROUND Tricuspid valve (TV) repair at the time of left-sided valve surgery is indicated in patients with either severe functional tricuspid regurgitation (TR) or mild-to-moderate TR with coexistent tricuspid annular dilation or right heart failure. We assessed the benefits of a concomitant TV repair strategy during left-sided surgical valve interventions, focusing on mortality and echocardiographic TR-related outcomes. METHODS A meta-analysis was performed of studies reporting outcomes of patients who underwent left-sided (mitral and/or aortic) valve surgery with or without concomitant TV repair. Primary endpoints were all-cause and cardiac-related mortality; secondary endpoints were the presence of more-than-moderate TR, TR progression, and TR severity grade. All endpoints were evaluated at the longest available follow-up. RESULTS Fifteen studies were included for a total of 2840 patients. TV repair at the time of left-sided valve surgery was associated with a significantly lower risk of cardiac-related mortality (odds ratio [OR] 0.38; 95% confidence interval [CI]: 0.25-0.58; p<0.001), with a trend towards a lower risk of all-cause mortality (OR 0.57; 95% CI: 0.32-1.05; p=0.07) at a mean weighted follow-up of 6years. The presence of more-than-moderate TR (OR 0.19; 95% CI: 0.12-0.30; p<0.001), TR progression (OR 0.03; 95% CI: 0.01-0.05; p<0.001), and TR grade (standardized mean difference -1.11; 95% CI: -1.57 to -0.65; p<0.001) were significantly lower in the TV repair group at a mean weighted follow-up of 4.7years. CONCLUSIONS A concomitant TV repair strategy during left-sided valve surgery is associated with a reduction in cardiac-related mortality and improved echocardiographic TR outcomes at follow-up.

Outcome after percutaneous edge-to-edge mitral repair for functional and degenerative mitral regurgitation: a systematic review and meta-analysis

Objectives Differences in terms of safety and efficacy of percutaneous edge-to-edge mitral repair between patients with functional and degenerative mitral regurgitation (MR) are not well established. We performed a systematic review and meta-analysis to clarify these differences. Methods PubMed, EMBASE, Google scholar database and international meeting abstracts were searched for all studies about MitraClip. Studies with <25 patients or where 1-year results were not delineated between MR aetiology were excluded. This study is registered with PROSPERO. Results A total of nine studies investigating the mid-term outcome of percutaneous edge-to-edge repair in patients with functional versus degenerative MR were included in the meta-analysis (n=2615). At 1 year, there were not significant differences among groups in terms of patients with MR grade≤2 (719/1304 vs 295/504; 58% vs 54%; risk ratio (RR) 1.12; 95% CI: 0.86 to 1.47; p=0.40), while there was a significantly lower rate of mitral valve re-intervention in patients with functional MR compared with those with degenerative MR (77/1770 vs 80/818; 4% vs 10%; RR 0.60; 95% CI: 0.38 to 0.97; p=0.04). One-year mortality rate was 16% (408/2498) and similar among groups (RR 1.26; 95% CI: 0.90 to 1.77; p=0.18). Functional MR group showed significantly higher percentage of patients in New York Heart Association class III/IV (234/1480 vs 49/583; 16% vs 8%; p<0.01) and re-hospitalisation for heart failure (137/605 vs 31/220; 23% vs 14%; p=0.03). No differences were found in terms of single leaflet device attachment (25/969 vs 20/464; 3% vs 4%; p=0.81) and device embolisation (no events reported in both groups) at 1 year. Conclusions This meta-analysis suggests that percutaneous edge-to-edge repair is likely to be an efficacious and safe option in patients with both functional and degenerative MR. Large, randomised studies are ongoing and awaited to fully assess the clinical impact of the procedure in these two different MR aetiologies.

Mechanism and Implications of the Tricuspid Regurgitation: From the Pathophysiology to the Current and Future Therapeutic Options

The tricuspid valve was virtually ignored for a long time in the past. However, significant tricuspid regurgitation (TR) often accompanies left-side heart valve pathology and does not always reverse with its correction. If left untreated, TR can progress and result in progressive right ventricular failure. Current guideline recommendations still hold minor differences. Nevertheless, there is a consensus to operate on patients with severe TR undergoing left-sided valve surgery (class I) or those with mild to moderate TR with a dilated annulus (≥40 or ≥21 mm2, Class IIa). However, in case of the primary TR, surgical options is limited by a relatively high risk of mortality and morbidity. For these patients, new percutaneous approaches are becoming available but no long-term data are still available. In this review, we provide a comprehensive overview of the epidemiological and pathophysiological aspects of TR, and the current and future directions of therapy.

Clinical outcomes following bifurcation double‐stenting with bioresorbable scaffolds

To investigate outcomes following bifurcation double‐stenting utilizing a bioresorbable scaffold (BRS) in the main branch (MB) and either a BRS or metallic drug‐eluting stent (DES) in the side branch (SB).

Cerebral Embolic Risk During Transcatheter Mitral Valve Interventions: An Unaddressed and Unmet Clinical Need?

As new transcatheter mitral valve (MV) interventions continuously evolve, potential procedure-related adverse events demand careful investigation. The risk of cerebral embolic damage is ubiquitous in any left-sided structural heart intervention (and potentially linked to long-term neurocognitive sequelae); therefore, efforts to evaluate these aspects in the field of catheter-based MV procedures are justified. Given the peculiarities of MV anatomy, MV disease, and MV procedures, the lessons learned from other transcatheter heart interventions (i.e., transcatheter aortic valve replacement) cannot be directly translated to MV applications. Through a systematic assessment of available evidence, the authors present and discuss procedure- and patient-related factors potentially associated with cerebral embolic risk during catheter-based MV interventions. Given the paucity of available data in this field, future large, dedicated studies are needed to understand whether cerebral embolic injury represents a real clinical issue during MV procedures.

Preliminary Report of Clinical Outcomes After Single Crossover Bioresorbable Scaffold Implantation Without Routine Side Branch Strut Dilation.

The objective of this study was to investigate clinical outcomes following single crossover bioresorbable scaffold (BRS) implantation without routine side branch (SB) strut dilation.

Relationship between Syntax Score and prognostic localization of coronary artery lesions with conventional risk factors, plasma profile markers, and carotid atherosclerosis (CAPP Study 2)

BACKGROUND Data concerning the relationship between cardiovascular risk factors, plasmatic markers, carotid disease and extent of coronary lesions are lacking. OBJECTIVES To evaluate the role of cardiovascular risk factors, plasmatic levels of high sensitivity C-reactive protein (hs-CRP), fibrinogen, lipoprotein(a), and carotid plaque extension in predicting the severity of coronary artery disease (CAD). METHODS We analyzed 574 subjects undergoing first coronary angiography. For angiographic analysis, we used the Syntax Score and we defined the prognostic localization of CAD as a critical stenosis of the left main and/or proximal segment of left anterior descending artery. Levels of hs-CRP >3mg/L, lipoprotein(a) plasma levels >30mg/dL and plasma fibrinogen >300mg/dL were considered critical. Significant carotid disease (SCD) was defined by the presence of lesions producing a 50% diameter stenosis with a peak systolic velocity >125cm/s. A mean carotid intima media thickness (IMT) >0.9mm was considered abnormal. RESULTS In the adjusted analysis the presence of SCD was found to be an independent predictor of high Syntax Score (p<0.001), while high fibrinogen levels were independently associated with the presence of CAD in prognostic localization (p=0.04). In the sub-group of patients without SCD, IMT >0.9mm was found to be an independent predictor of the presence of CAD (p<0.001). CONCLUSIONS SCD strongly predicts high Syntax Score, while IMT shows excellent positive predictive value for the presence of CAD. In addition, high plasma fibrinogen levels are associated with coronary stenoses in prognostic localization.

Predilatation Prior to Transcatheter Aortic Valve Implantation: Is it Still a Prerequisite?

Predilatation has been historically considered a mandatory step before transcatheter aortic valve implantation (TAVI) since it facilitates valve crossing and prosthesis delivery, ensures optimal valve expansion and improves hemodynamic stability during valve deployment. However, as a result of procedural evolution over time, direct TAVI (without pre-implantation balloon aortic valvuloplasty) has emerged as an interesting option to simplify the procedure and to avoid potential valvuloplasty-related complications. Several real-world retrospective studies and one small randomised study have shown that direct TAVI (with both self-expanding and balloon-expandable prostheses) is feasible, safe and associated with outcomes similar to standard TAVI with pre-implantation balloon aortic valvuloplasty. In the absence of high-quality, robust evidence, the current review aims to discuss the advantages and disadvantages of omitting predilatation prior to TAVI.