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Introduction: Patients with aortic stenosis often develop hypertrophy and fibrosis, regardless of symptoms. Cardiac Magnetic Resonance (CMR) represents the gold standard for the evaluation of fibrosis despite numerous limitations: cost, availability, atrial fibrillation, claustrophobia, kidney failure or inability to apnea. Purpose: The aim is to validate the role of echocardiographic parameters, such as Global Longitudinal Strain (GLS), as early markers of fibrosis. Clinical and laboratory data, particularly B-type Natriuretic Peptide (BNP), were also analyzed. Material and methods: In our study we recruited 33 patients with severe aortic stenosis, correlating echocardiographic values of GLS with the qualitative analysis of Late Gadolinium Enhancement (LGE) and the quantitative analysis of T1 mapping of CMR. Results: 70% of patients with an alteration of GLS had LGE+. Univariate logistic regression shows that the factors associated with the presence of LGE on CMR are hypertension (p = 0.043), GLS (p = 0.032), and elevated BNP values (p = 0.021); for GLS, Odds Ratio (OR) is 5 so the chance of finding fibrosis on CMR increases 5 times in presence of an altered GLS. The multivariate analysis confirms the association with impaired GLS values (p = 0.033) and hypertension (p = 0.025), but not with elevated Pro-BNP values. Conclusion: In patients with severe aortic stenosis, the association between GLS, LGE, and T1 mapping can help identify earlier those patients with structural changes caused by the disease, who could benefit from early intervention. It remains to be established how the presence of these alterations has a role in determining the intervention time and the outcome of these patients.

BACKGROUND: The next-generation ACURATE neo2 transcatheter aortic valve was designed for simplified implantation and to mitigate the risk of paravalvular leak (PVL) compared to the earlier device.AIMS: To collect clinical outcomes and device performance data, including echocardiography and 4-dimensional computed tomography (4D-CT) data, with the ACURATE neo2 transcatheter heart valve in patients with severe aortic stenosis (AS).METHODS: ACURATE neo2 PMCF is a single-arm, multicentre study of patients with severe AS treated in routine clinical practice. The primary safety endpoint was all-cause mortality at 30-days. The primary imaging endpoint was hypo-attenuated leaflet thickening (HALT), measured by core laboratory-adjudicated 4D-CT at 30 days. Secondary endpoints included VARC safety endpoints, procedural success, and evaluation of valve performance via core laboratory-adjudicated echocardiography.RESULTS: The study enrolled 250 patients at 18 European centres (mean age: 80.8 years; 63.6% female; mean STS score: 2.9±2.0%); 246 (98.4%) were successfully treated with ACURATE neo2. The 30-day rates for mortality and disabling stroke were 0.8% and 0%, respectively. The new permanent pacemaker implantation rate was 6.5%. HALT >50% was present in 9.3% of patients at 30 days. Valve haemodynamics improved from baseline to 30 days (mean aortic valve gradient: from 47.6±14.5 mmHg to 8.6±3.9 mmHg; mean aortic valve area: from 0.7±0.2 cm2 to 1.6±0.4 cm2). At 30 days, PVL was evaluated as none/trace in 79.2% of patients, mild in 18.9%, moderate in 1.9%, and severe in 0%.CONCLUSIONS: The study results support the safety and efficacy of TAVI with ACURATE neo2 in patients in routine clinical practice.

Background: The optimal access route in patients with severe peripheral artery disease (PAD) undergoing transcatheter aortic valve replacement (TAVR) remains undetermined. Objectives: This study sought to compare clinical outcomes with transfemoral access (TFA), transthoracic access (TTA), and nonthoracic transalternative access (TAA) in TAVR patients with severe PAD. Methods: Patients with PAD and hostile femoral access (TFA impossible, or possible only after percutaneous treatment) undergoing TAVR at 28 international centers were included in this registry. The primary endpoint was the propensity-adjusted risk of 30-day major adverse events (MAE) defined as the composite of all-cause mortality, stroke/transient ischemic attack (TIA), or main access site–related Valve Academic Research Consortium 3 major vascular complications. Outcomes were also stratified according to the severity of PAD using a novel risk score (Hostile score). Results: Among the 1,707 patients included in the registry, 518 (30.3%) underwent TAVR with TFA after percutaneous treatment, 642 (37.6%) with TTA, and 547 (32.0%) with TAA (mostly transaxillary). Compared with TTA, both TFA (adjusted HR: 0.58; 95% CI: 0.45-0.75) and TAA (adjusted HR: 0.60; 95% CI: 0.47-0.78) were associated with lower 30-day rates of MAE, driven by fewer access site–related complications. Composite risks at 1 year were also lower with TFA and TAA compared with TTA. TFA compared with TAA was associated with lower 1-year risk of stroke/TIA (adjusted HR: 0.49; 95% CI: 0.24-0.98), a finding confined to patients with low Hostile scores (Pinteraction = 0.049). Conclusions: Among patients with PAD undergoing TAVR, both TFA and TAA were associated with lower 30-day and 1-year rates of MAE compared with TTA, but 1-year stroke/TIA rates were higher with TAA compared with TFA.

BACKGROUND In the first report from the MitraBridge registry, MitraClip as a bridge to heart transplantation (HTx) proved to be at 1-year an effective treatment strategy for 119 patients with advanced heart failure (HF) who were potential candidates for HTx. We aimed to determine if benefits of MitraClip procedure as a bridge-to-transplant persist up to 2-years. METHODS By the end of the enrollment period, a total of 153 advanced HF patients (median age 59 years, left ventricular ejection fraction 26.9 ± 7.7%) with significant secondary mitral regurgitation, who were potential candidates for HTx and were treated with MitraClip as a bridge-to-transplant strategy, were included in the MitraBridge registry. The primary endpoint was the 2-year composite adverse events rate of all-cause death, first hospitalization for HF, urgent HTx or LVAD implantation. RESULTS Procedural success was achieved in 89.5% of cases. Thirty-day mortality was 0%. At 2-year, Kaplan-Meier estimates of freedom from primary endpoint was 47%. Through 24 months, the annualized rate of HF rehospitalization per patient-year was 44%. After an overall median follow-up time of 26 (9-52) months, elective HTx was successfully performed in 30 cases (21%), 19 patients (13.5%) maintained or obtained the eligibility for transplant, and 32 patients (22.5%) no longer had an indication for HTx because of significant clinical improvement. CONCLUSIONS After 2-years of follow-up, the use of MitraClip as a bridge-to-transplant was confirmed as an effective strategy, allowing elective HTx or eligibility for transplant in one third of patients, and no more need for transplantation in 22.5% of cases.

BACKGROUND The optimal access route in patients with severe peripheral artery disease (PAD) undergoing transcatheter aortic valve replacement (TAVR) remains undetermined. OBJECTIVES This study sought to compare clinical outcomes with transfemoral access (TFA), transthoracic access (TTA), and nonthoracic transalternative access (TAA) in TAVR patients with severe PAD. METHODS Patients with PAD and hostile femoral access (TFA impossible, or possible only after percutaneous treatment) undergoing TAVR at 28 international centers were included in this registry. The primary endpoint was the propensity-adjusted risk of 30-day major adverse events (MAE) defined as the composite of all-cause mortality, stroke/transient ischemic attack (TIA), or main access site-related Valve Academic Research Consortium 3 major vascular complications. Outcomes were also stratified according to the severity of PAD using a novel risk score (Hostile score). RESULTS Among the 1,707 patients included in the registry, 518 (30.3%) underwent TAVR with TFA after percutaneous treatment, 642 (37.6%) with TTA, and 547 (32.0%) with TAA (mostly transaxillary). Compared with TTA, both TFA (adjusted HR: 0.58; 95% CI: 0.45-0.75) and TAA (adjusted HR: 0.60; 95% CI: 0.47-0.78) were associated with lower 30-day rates of MAE, driven by fewer access site-related complications. Composite risks at 1 year were also lower with TFA and TAA compared with TTA. TFA compared with TAA was associated with lower 1-year risk of stroke/TIA (adjusted HR: 0.49; 95% CI: 0.24-0.98), a finding confined to patients with low Hostile scores (Pinteraction = 0.049). CONCLUSIONS Among patients with PAD undergoing TAVR, both TFA and TAA were associated with lower 30-day and 1-year rates of MAE compared with TTA, but 1-year stroke/TIA rates were higher with TAA compared with TFA.

Data on left main (LM) percutaneous coronary interventions (PCI) have mostly been obtained in studies using drug-eluting stent (DES) platforms without dedicated large-vessel devices and with limited expansion capability.Our study aimed to investigate the safety and efficacy of LM PCI with the latest-generation Resolute Onyx DES.ROLEX (Revascularization Of LEft main with resolute onyX) is a prospective, multicentre study (ClinicalTrials.gov: NCT03316833) enrolling patients with unprotected LM coronary artery disease and a SYNTAX score33 undergoing PCI with the Resolute Onyx zotarolimus-eluting coronary stent, that includes dedicated extra-large vessel platforms. The primary endpoint (EP) was target lesion failure (TLF): a composite of cardiac death, target vessel myocardial infarction (TVMI) and ischaemia-driven target lesion revascularisation (ID-TLR), at 1 year. All events were adjudicated by an independent clinical event committee. An independent core lab analysed all procedural angiograms.A total of 450 patients (mean age 71.8 years, SYNTAX score 24.5±7.2, acute coronary syndrome in 53%) were enrolled in 26 centres. Of these, 77% of subjects underwent PCI with a single-stent and 23% with a 2-stent technique (8% double kissing [DK] crush, 6% culotte, 9% T/T and small protrusion [TAP] stenting). Intravascular imaging guidance was used in 45% (42% intravascular ultrasound [IVUS], 3% optical coherence tomography [OCT]). At 1 year, the primary EP incidence was 5.1% (cardiac death 2.7%, TVMI 2.7%, ID-TLR 2.0%). The definite/probable stent thrombosis rate was 1.1%. In a prespecified adjusted subanalysis, the primary EP incidence was significantly lower in patients undergoing IVUS/OCT-guided versus angio-guided PCI (2.0 vs 7.6%; hazard ratio [HR] 0.28, 95% confidence interval [CI]: 0.13-0.58; p0.001).In this large, multicentre, prospective registry, LM PCI with the Resolute Onyx DES showed good safety and efficacy at 1 year, particularly when guided by intracoronary imaging.

We evaluated the acute and two-year safety and efficacy of using the Corevalve, Evolut R, and Evolut PRO valves for treating failed surgical bioprosthesis from the Italian CoreValve Clinical Service Project.Valve-in-valve (ViV) TAVR is an emerging treatment option for failed surgical bioprosthesis. Choice of transcatheter valve is an important determinant of procedural and clinical outcomes, however, longer-term data are lacking.The Clinical Service Project is a national clinical data repository evaluating the use of implantable devices across Italy. The present multi-center analysis includes consecutive patients who underwent ViV-TAVR with the Medtronic CoreValve series between October 2008 to June 2019. Evaluated endpoints included rates of overall mortality, cardiovascular mortality, myocardial infarction, and cerebrovascular accidents at 2-year follow-up. Procedural success, complications, and echocardiographic outcomes were reported according to VARC-2 criteria.A total of 139 patients (mean age, 80 ± 7 years; 47.5% male; mean STS score, 10.0 ± 9.7%) underwent ViV-TAVR with CoreValve (28.5%), Evolut R (68.6%), and Evolut Pro (2.9%) valves. Device success was achieved in 68% and acute coronary obstruction requiring PCI was observed in 4 patients (2.9%). Moderate PVL was observed in 3.7% and 2.8% of patients at 30-day and 2-year follow-up and moderate structural valve degeneration seen only 5 patients (3.6%). All-cause and cardiovascular mortality were 3.6% and 2.9% at 30 days, respectively, and 20.6% and 10.2% at 2-year follow-up.This real-world nationwide analysis demonstrates the acute and longer-term safety and efficacy of using the self-expanding Medtronic THV for ViV-TAVR.

Background: The best management of stable coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI) is still unclear due to the marked inconsistency of the available evidence. Methods: The REVASC-TAVI registry (Management of Myocardial Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation With Coronary Artery Disease) collected data from 30 centers worldwide on patients undergoing TAVI who had significant, stable CAD at preprocedural work-up. For the purposes of this analysis, patients with either complete or incomplete myocardial revascularization were compared in a propensity score matched analysis, to take into account of baseline confounders. The primary and co-primary outcomes were all-cause death and the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure, respectively, at 2 years. Results: Among 2407 patients enrolled, 675 pairs of patients achieving complete or incomplete myocardial revascularization were matched. The primary (21.6% versus 18.2%, hazard ratio‚ 0.88 [95% CI, 0.66–1.18]; P =0.38) and co-primary composite (29.0% versus 27.1%, hazard ratio‚ 0.97 [95% CI, 0.76–1.24]; P =0.83) outcome did not differ between patients achieving complete or incomplete myocardial revascularization, respectively. These results were consistent across different prespecified subgroups of patients (< or >75 years of age, Society of Thoracic Surgeons score > or or P values for interaction >0.10). Conclusions: The present analysis of the REVASC-TAVI registry showed that, among TAVI patients with significant stable CAD found during the TAVI work-up, completeness of myocardial revascularization achieved either staged or concomitantly with TAVI was similar to a strategy of incomplete revascularization in reducing the risk of all cause death, as well as the risk of death, stroke, myocardial infarction, and rehospitalization for heart failure at 2 years, regardless of the clinical and anatomical situations.

The first-generation ACURATE neo transcatheter heart valve (THV) (Boston Scientific) was associated with a non-negligible occurrence of moderate or greater paravalvular aortic regurgitation (AR) following transcatheter aortic valve replacement. To overcome this issue, the ACURATE neo2 iteration, which incorporates a taller outer skirt aimed at reducing the occurrence of paravalvular AR, has recently been developed.The aim of this study was to assess the efficacy and safety of the ACURATE neo2 (Boston Scientific) THV in patients with severe aortic valve stenosis.ITAL-neo was an observational, retrospective, multicenter registry enrolling consecutive patients with severe aortic valve stenosis, treated with first- and second-generation ACURATE neo THVs, via transfemoral and trans-subclavian access, in 13 Italian centers. One-to-one propensity score matching was applied to account for baseline characteristics unbalance. The primary endpoint was the occurrence of moderate or greater paravalvular AR on predischarge echocardiographic assessment. Secondary endpoints included postprocedural technical success and 90-day device success and safety.Among 900 patients included in the registry, 220 received the ACURATE neo2 THV, whereas 680 were treated with the first-generation device. A total of 410 patients were compared after 1:1 propensity score matching. The ACURATE neo2 THV was associated with a 3-fold lower frequency of postprocedural moderate or greater paravalvular AR (11.2% vs 3.5%; P 0.001). No other hemodynamic differences were observed. Postprocedural technical success was similar between the 2 cohorts. Fewer adverse events were observed in patients treated with the ACURATE neo2 at 90 days.Transfemoral transcatheter aortic valve replacement using the ACURATE neo2 was associated with a significant lower frequency of moderate or greater paravalvular AR compared with the earlier generation ACURATE neo device, with encouraging short-term safety and efficacy.

Transcatheter aortic valve implantation (TAVI) has revolutionised the treatment of severe, symptomatic aortic stenosis and it is now a proven and effective alternative to surgery for patients regardless of preoperative risk stratification. Nevertheless, the consequent expansion towards younger patients with longer life expectancy focuses attention on long-term considerations. In particular, although the prevalence of coronary artery disease has been shown to decrease with the lowering of estimated risk stratification, the chance of requirement of future coronary interventions after TAVI increases dramatically as a function of patients' life expectancy. To date, however, only a few studies have investigated the feasibility and reproducibility of coronary artery cannulation after TAVI. Different conditions related mainly to aortic root anatomy and specific transcatheter aortic valve (TAV) designs and deployment have been associated with impaired coronary access after TAVI. In the present review, we will examine the conditions that may make coronary access after TAVI more challenging or even impossible.

Vascular complications still represent an important issue after transcatheter aortic valve implantation (TAVI).The aim of this study was to evaluate the effectiveness of upfront use of an adjunctive Angio-Seal (AS) plug-based system on top of suture-based devices (SBDs) for endovascular haemostasis after transfemoral (TF) TAVI.From January 2019 to April 2020, 332 consecutive patients with preprocedural computed tomography angiography (CTA) assessment underwent fully percutaneous TF-TAVI. The primary outcomes were 30-day major vascular complications and major or life-threatening (LT) bleeding due to endovascular closure system failure. A total of 246 TF-TAVI patients (123 pairs), undergoing either isolated SBD or SBD+AS, were matched using the propensity-score method.At 30 days, patients receiving SBD+AS had lower rates of major/LT bleeding (1.6% vs 8.9%, odds ratio [OR] 0.17, 95% confidence interval [CI]: 0.04-0.78; p0.01) and major vascular complications (1.6% vs 8.9%, OR 0.17, 95% CI: 0.04-0.78; p0.01). In addition, the use of SBD+AS was associated with a significant cost saving related to the vascular event (mean difference -315.3 € per patient, 95% CI: -566.4 € to -64.1 €; p=0.01), and a higher probability of next-day discharge (NDD) after TAVI (30.9% vs 16.3%, OR 2.30, 95% CI: 1.25-4.25; p0.01). No difference in all-cause 30-day mortality was observed (3.3% vs 1.6% for SBD and SBD+AS groups, respectively, OR 0.49, 95% CI: 0.09-2.74; p=0.41).An upfront combined strategy with an additional AS plug-based device on top of SBDs was shown to reduce major vascular complications and major/LT bleeding due to closure system failure after TF-TAVI. This approach was associated with a cost saving and with a higher probability of NDD compared to the use of isolated SBD. Visual summary. Effectiveness of the upfront combined strategy for endovascular haemostasis in transfemoral transcatheter aortic valve implantation using Angio-Seal on top of a suture-based device (SBD) versus the isolated use of SBD. LT: life-threatening; TF-TAVI: transfemoral transcatheter aortic valve implantation.

The novel sirolimus-eluting ultra-high molecular weight 115-microns strut thickness APTITUDE® Bioreabsorbable vascular scaffold (BRS) (Amaranth Medical Inc., Mountain View, CA) displays higher mechanical strength, expansion capabilities and resistance to fracture compared to clinically available BRS technologies. RENASCENT II is a prospective, multi-center first-in-human clinical study to evaluate the clinical performance of the APTITUDE® BRS in the treatment of single de novo coronary lesions among patients undergoing percutaneous coronary intervention.

The aim of this study was to investigate the safety and efficacy of coronary protection by preventive coronary wiring and stenting across the coronary ostia in patients at high risk for coronary obstruction after transcatheter aortic valve replacement (TAVR).

The Italian Society of Interventional Cardiology (GIse) registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO) was conceived in order to assess the safety and efficacy of MitraClip therapy in Italy. The aim of this study was to assess procedural and mid-term outcomes, and clinical and echocardiographic predictors of mid-term mortality after MitraClip therapy, stratifying the results according to the diagnosis of functional and degenerative mitral regurgitation (FMR vs. DMR).Between January 2016 and March 2020, 1659 patients were prospectively included in the GIOTTO registry (FMR 59.4% vs. DMR 40.6%). Acute Mitral Valve Academic Research Consortium (MVARC) technical success was achieved in 97.2% of patients, without differences between FMR and DMR and with sustained results at 30 days. In the study population, all-cause mortality was 4.0%, 17.5% and 34.6% at 30 days, 1 year and 2 years, respectively. Cardiovascular death was the most frequent cause of mortality. Overall hospitalization rates were 6.3%, 23.4% and 31.7% at 30 days, 1 year and 2 years, respectively. The most frequent cause of hospitalization was heart failure, particularly in the first 30 days. FMR and MVARC structural and functional failure were strongly associated with 1-year mortality. Residual mitral regurgitation 1+ (rMR) was independently related to a reduced risk of 1-year mortality (hazard ratio 0.62; P = 0.005). Coherently, at 2-year follow up, FMR was associated with worse outcomes than DMR, and Kaplan-Meier all-cause mortality was related to rMR.Functional mitral regurgitation aetiology affects 1-year mortality after MitraClip implantation, and differences in mortality and hospitalization rates between FMR and DMR can be observed within 2 years. Optimal rMR 1+ was correlated to a more favourable mid-term outcome, particularly in FMR.

Background Polymer-free drug-eluting stents are based on different technologies for drug binding and release without the use of polymer coatings. It is unknown whether different polymer-free drug-eluting stents are comparable in terms of safety and efficacy profiles. Methods and Results Polymer-free BioFreedom biolimus-eluting stents (BES) and polymer-free Cre8 amphilimus-eluting stents (AES) were investigated in 2 recent multicenter registries including 2320 all-comer patients undergoing percutaneous coronary interventions at 22 Italian centers. Using propensity score matching, safety and efficacy outcomes were compared among 1280 patients (640 matched pairs) treated with BioFreedom BES or Cre8 AES. The primary end point was target lesion failure-a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization (TLR). At 1 year, target lesion failure occurred in 4.0% of BES and 4.2% of AES-treated patients (hazard ratio [HR] 0.98, 95% CI, 0.57-1.70). Risks of cardiac death (2.0% versus 2.1%; HR, 1.03; 95% CI, 0.47-2.26), target vessel myocardial infarction (0.8% versus 0.3%; HR, 1.89; 95% CI, 0.50-6.80), TLR (1.5% versus 2.2%; HR, 0.74; 95% CI, 0.34-1.62), and definite/probable stent thrombosis (0.9% versus 0.8%; HR, 1.17; 95% CI, 0.36-3.81) were comparable in patients treated with BioFreedom BES and Cre8 AES. A differential treatment effect by diabetes mellitus status was observed, indicating a benefit of AES in patients with diabetes mellitus ( P interaction=0.003). Conclusions The present study shows that BioFreedom BES and Cre8 AES have favorable and comparable safety and efficacy profiles in all-comer patients undergoing percutaneous coronary intervention. Further evaluation in large-scale, randomized trials are necessary to confirm our findings.

The aims of this study were to investigate the feasibility of coronary ostia cannulation after transcatheter aortic valve replacement (TAVR) and to assess potential predictors of coronary access impairment.Certain data concerning the feasibility and reproducibility of coronary cannulation after TAVR are lacking.RE-ACCESS (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent) was an investigator-driven, single-center, prospective, registry-based study that enrolled consecutive patients undergoing TAVR using all commercially available devices. All patients underwent coronary angiography before and after TAVR. The primary endpoint was the rate of unsuccessful coronary ostia cannulation after TAVR. Secondary endpoints were the identification of factors associated with the inability to selectively cannulate coronary ostia after TAVR.Among 300 patients enrolled in the RE-ACCESS study from December 2018 to January 2020, a total of 23 cases (7.7%) of unsuccessful coronary cannulation after TAVR were documented. This issue occurred in 22 of 23 cases with the use of Evolut R/PRO transcatheter aortic valves (TAVs) (17.9% vs. 0.4%; p 0.01). In multivariate analysis, the use of Evolut R/PRO TAVs (odds ratio [OR]: 29.6; 95% confidence interval [CI]: 2.6 to 335.0; p 0.01), the TAV-sinus of Valsalva relation (OR: 1.1 per 1-mm increase; 95% CI: 1.0 to 1.2; p 0.01), and the mean TAV implantation depth (OR: 1.7 per 1-mm decrease; 95% CI: 1.3 to 2.3; p 0.01) were found to be independent predictors of unsuccessful coronary cannulation after TAVR. A model combining these factors was demonstrated to predict with very high accuracy the risk for unsuccessful coronary cannulation after TAVR (area under the curve: 0.94; p 0.01).Unsuccessful coronary cannulation following TAVR was observed in 7.7% of patients and occurred almost exclusively in those receiving Evolut TAVs. The combination of Evolut TAV, a higher TAV-sinus of Valsalva relation, and implantation depth predicts with high accuracy the risk for unsuccessful coronary cannulation after TAVR. (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent [RE-ACCESS]; NCT04026204).

Transcatheter edge-to-edge mitral valve repair is a viable alternative to surgery in patients with severe mitral regurgitation and high surgical risk. Yet the specific group of patients who would optimally benefit from this therapy remains to be determined. Selection of patients for transcatheter strategy is currently based on surgical prognostic scores and technical feasibility. Meanwhile, various clinical, anatomic, and procedural factors have been recently recognized as predictors of adverse outcomes following transcatheter edge-to-edge mitral valve repair, including device failure, recurrent mitral regurgitation, and mortality. Integration of these prognostic factors in the decision-making process of the heart team might improve patient management and outcomes. Herein, the authors review the different factors related to symptomatic status, comorbidity, serum biomarkers, echocardiographic findings, and procedural technique that have been identified as independent predictors of adverse outcome following transcatheter edge-to-edge mitral valve repair and discuss their potential application in everyday clinical practice.

Aims To evaluate the impact of the COVID-19 pandemic on patient admissions to Italian cardiac care units (CCUs). Methods and Results We conducted a multicentre, observational, nationwide survey to collect data on admissions for acute myocardial infarction (AMI) at Italian CCUs throughout a 1 week period during the COVID-19 outbreak, compared with the equivalent week in 2019. We observed a 48.4% reduction in admissions for AMI compared with the equivalent week in 2019 (P < 0.001). The reduction was significant for both ST-segment elevation myocardial infarction [STEMI; 26.5%, 95% confidence interval (CI) 21.7–32.3; P = 0.009] and non-STEMI (NSTEMI; 65.1%, 95% CI 60.3–70.3; P < 0.001). Among STEMIs, the reduction was higher for women (41.2%; P = 0.011) than men (17.8%; P = 0.191). A similar reduction in AMI admissions was registered in North Italy (52.1%), Central Italy (59.3%), and South Italy (52.1%). The STEMI case fatality rate during the pandemic was substantially increased compared with 2019 [risk ratio (RR) = 3.3, 95% CI 1.7–6.6; P < 0.001]. A parallel increase in complications was also registered (RR = 1.8, 95% CI 1.1–2.8; P = 0.009). Conclusion Admissions for AMI were significantly reduced during the COVID-19 pandemic across Italy, with a parallel increase in fatality and complication rates. This constitutes a serious social issue, demanding attention by the scientific and healthcare communities and public regulatory agencies.

AIMS The safety and efficacy of single vs. dual antiplatelet therapy (DAPT) in patients undergoing TAVI remain to be addressed. The aim of our study was to evaluate the usefulness of a DAPT compared to a single platelet therapy in patients undergoing TAVI with a balloon-expandable prosthesis. METHODS AND RESULTS All consecutive patients enrolled in the ITER registry were included. Patients undergoing TAVI discharged with aspirin alone were compared to those taking DAPT before and after selection using propensity score with matching. Subgroup analysis was performed for those on OAT. Prosthetic heart valve dysfunction at follow-up was the primary endpoint, whereas all-cause death, cardiovascular death, bleedings, vascular complications and cerebrovascular accidents were the secondary ones. From 1,364 patients, after propensity score with matching, 605 were selected for each group (aspirin alone vs. DAPT). At 30 days, rates of VARC mortality were lower in patients with aspirin alone (1.5% vs. 4.1%, p=0.003), mainly driven by a reduction of major vascular complications (5.3% vs. 10.7%, p

Transcatheter aortic valve implantation (TAVI) has revolutionized the management of patients with symptomatic severe aortic stenosis and has become the standard of care for inoperable patients and the preferred therapy for those at increased surgical risk with peculiar clinical and anatomic features. Technology advances, growing experience and accumulating data prompted the update of the 2011 Italian Society of Interventional Cardiology (SICI-GISE) position paper on institutional and operator requirements to perform TAVI. The main objective of this document is to provide a guidance to assess the potential of institutions and operators to initiate and maintain an efficient TAVI program.

OBJECTIVES The aim of this study was to compare transcatheter aortic valve replacement (TAVR) with the Acurate neo (NEO) and Evolut PRO (PRO) devices. BACKGROUND The NEO and PRO bioprostheses are 2 next-generation self-expanding devices developed for TAVR. METHODS The NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) registry retrospectively included patients who underwent transfemoral TAVR with either NEO or PRO valves at 24 centers between January 2012 and March 2018. One-to-one propensity score matching resulted in 251 pairs. Pre-discharge and 30-day Valve Academic Research Consortium (VARC)-2 defined outcomes were evaluated. Binary logistic regression was performed to adjust the treatment effect for propensity score quintiles. RESULTS A total of 1,551 patients (n = 1,263 NEO; n = 288 PRO) were included. The mean age was 82 years, and the mean Society of Thoracic Surgeons score was 5.1%. After propensity score matching (n = 502), VARC-2 device success (90.6% vs. 91.6%; p = 0.751) and pre-discharge moderate to severe (II+) paravalvular aortic regurgitation (7.3% vs. 5.7%; p = 0.584) were comparable between the NEO and PRO groups. Furthermore, there were no significant differences in any 30-day clinical outcome between matched NEO and PRO pairs, including all-cause mortality (3.2% vs. 1.2%; p = 0.221), stroke (2.4% vs. 2.8%; p = 1.000), new permanent pacemaker implantation (11.0% vs. 12.8%; p = 0.565), and VARC-2 early safety endpoint (10.6% vs. 10.4%; p = 1.000). Logistic regression on the unmatched cohort confirmed a similar risk of VARC-2 device success, paravalvular aortic regurgitation II+, and 30-day clinical outcomes after NEO and PRO implantation. CONCLUSIONS In this multicenter registry, transfemoral TAVR with the NEO and PRO bioprostheses was associated with high device success, acceptable rates of paravalvular aortic regurgitation II+, and good 30-day clinical outcomes. After adjusting for potential confounders, short-term outcomes were similar between the devices.

Rationale. The impact of transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (AVR) on cognitive status and quality of life in high-risk patients has been incompletely investigated. Methods. We conducted a prospective, multicenter study including all patients treated with TAVI and high-risk patients undergoing AVR (age ≥80 years or logistic EuroSCORE ≥15%) at participating centers. Multidimensional geriatric evaluation including Mini Mental State Examination (MMSE), EuroQol 5D (EQ5D) and Minnesota Living With Heart Failure Questionnaire (MLHFQ) were performed at baseline and at 3- and 12-month follow-up. Results. A total of 518 patients (151 AVR and 367 TAVI) were enrolled in 10 Italian institutions. Patients receiving AVR were older (82.7 ± 2.4 years), with a lower logistic EuroSCORE (12.5 ± 7.1%) as compared with TAVI patients (81.5 ± 6.2 years and 19.6 ± 14.0%, respectively, p=0.001 and p

Background Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking. Objectives This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice. Methods The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter, observational study. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in 1,038 patients with symptomatic, severe AS at 53 centers on 4 continents. Results Mean age was 81.8 ± 6.2 years, 64.9% were women, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5%, and 33.9% of patients were deemed frail. The repositioning feature of the THV was applied in 25.8% of patients. A single valve was implanted in the proper anatomic location in 98.9% of patients. The mean aortic valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9% at discharge. All-cause mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The expected-to-observed early surgical mortality ratio was 0.35. A pacemaker was implanted in 17.5% of patients. Conclusions TAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369)

Item does not contain fulltext AIMS: Bioresorbable vascular scaffolds (BVS) represent a novel therapeutic option for the treatment of coronary artery diseases. The objective of this study was to evaluate the feasibility of BVS implantation in complex chronic total occlusions (CTO). METHODS AND RESULTS: The present report is a multicentre registry evaluating results after BVS deployment in challenging CTO lesions, defined as J-CTO score >/=2 (difficult or very difficult). A total of 105 patients were included in the present analysis. The mean J-CTO score was 2.61 (difficult 52.4%, very difficult 47.6%). Device success and procedural success rates were 98.1% and 97.1%, respectively. The retrograde approach was used in 25.7% of cases. After wire crossing, predilatation was performed in all cases with a mean predilatation balloon diameter of 2.73+/-0.43 mm. The mean scaffold length was 59.75+/-25.85 mm, with post-dilatation performed in 89.5% of the cases and a mean post-dilatation balloon diameter of 3.35+/-0.44 mm. Post-PCI minimal lumen diameter was 2.50+/-0.51 mm and percentage diameter stenosis 14.53+/-10.31%. At six-month follow-up, a total of three events were reported: one periprocedural myocardial infarction, one late scaffold thrombosis and one additional target lesion revascularisation. CONCLUSIONS: The present report suggests the feasibility of BVS implantation in complex CTO lesions, given adequate lesion preparation and post-dilatation, with good acute angiographic results and midterm clinical outcomes.

We report on the mid-term outcomes of patients undergoing percutaneous coronary intervention with bioresorbable vascular scaffolds (BVS) for the treatment of acute coronary syndromes (ACS) and compare with those of patients with stable coronary artery disease (sCAD).

Objectives: The aim of this study was to evaluate midterm outcomes of bioresorbable vascular scaffolds (BVS) implanted in bifurcation lesions. Background: BVS have emerged as an alternative to conventional metallic drug-eluting stents for the treatment of coronary complex lesions. Methods: Between November 2011 and January 2014, 1189 patients underwent percutaneous coronary intervention with BVS at 10 European centers (GHOST EU registry). Of these, 289 consecutive patients (302 bifurcation lesions) treated with either single-stenting (n = 260) or double-stenting (n = 42) were evaluated. Results: True bifurcations were treated in 44.7%. Intravascular ultrasound and optical coherence tomography were utilized only in 22.2% and 21.2%, respectively. Predilation was performed in 95.4%, while postdilation of the main branch was performed in 61.3%. Final kissing inflation with no or minimal protrusion of a side-branch balloon into main branch was performed in 18.9%. Median follow-up period was 356 (IQR 191–419) days. The Kaplan–Meier estimated rates of target lesion failure and scaffold thrombosis (ST) were 6.4% and 2.5% at 360 days, respectively. Independent predictors for TLF were ACS and diabetes mellitus (HR 4.67; 95% CI: 1.78–12.3; P = 0.002 and HR 3.37; 95% CI: 1.38–8.26; P = 0.008, respectively). Conclusions: BVS use for coronary bifurcation lesions in an “all-comer” population was associated with acceptable TLF rates up to midterm follow-up. However, ST rates were higher than seen with contemporary metallic stents possibly due to the low incidence of intravascular guidance and postdilation resulting in a higher likelihood of scaffold underexpansion and malapposition, further supporting the importance of meticulous implantation technique. © 2016 Wiley Periodicals, Inc.

Aims Left atrial appendage closure is a non-pharmacological alternative for stroke prevention in high-risk patients with non-valvular atrial fibrillation. The objective of the multicentre EWOLUTION registry was to obtain clinical data on procedural success and complications, and long-term patient outcomes, including bleeding and incidence of stroke/transient ischaemic attack (TIA). Here, we report on the peri-procedural outcomes of up to 30 days. Methods and results Baseline/implant data are available for 1021 subjects. Subjects in the study were at high risk of stroke (average CHADS 2 score: 2.8 ± 1.3, CHA 2 DS 2 -VASc: 4.5 ± 1.6) and moderate-to-high risk of bleeding (average HAS-BLED score: 2.3 ± 1.2). Almost half of the subjects (45.4%) had a history of TIA, ischaemic stroke, or haemorrhagic stroke; 62% of patients were deemed unsuitable for novel oral anticoagulant by their physician. The device was successfully deployed in 98.5% of patients with no flow or minimal residual flow achieved in 99.3% of implanted patients. Twenty-eight subjects experienced 31 serious adverse events (SAEs) within 1 day of the procedure. The overall 30-day mortality rate was 0.7%. The most common SAE occurring within 30 days of the procedure was major bleeding requiring transfusion. Incidence of SAEs within 30 days was significantly lower for subjects deemed to be ineligible for oral anticoagulation therapy (OAT) compared with those eligible for OAT (6.5 vs. 10.2%, P = 0.042). Conclusion Left atrial appendage closure with the WATCHMAN device has a high success rate in complete LAAC with low peri-procedural risk, even in a population with a higher risk of stroke and bleeding, and multiple co-morbidities. Improvement in implantation techniques has led to a reduction of peri-procedural complications previously limiting the net clinical benefit of the procedure.

Background—Chronic liver disease is a known risk factor for perioperative morbidity and mortality in patients undergoing cardiac surgery. Very little data exist about such patients treated with transcatheter aortic valve replacement (TAVR). Our objective was to evaluate early and late clinical outcomes in a large cohort of patients with liver disease undergoing TAVR and to determine predictive factors of mortality among these patients. Methods and Results—This multicenter study collected data from 114 patients with chronic liver disease who underwent TAVR in 12 institutions. Perioperative and long-term outcomes were compared with a cohort of 1118 patients without liver disease after a propensity score–matching analysis (114 matched pairs). In-hospital mortality and vascular and bleeding complications were similar between matched groups. Acute kidney injury was more common in liver disease group (30.8% versus 13.5%; P=0.010). Although cardiovascular mortality was similar between groups (9.4% versus 6.5%; P=0.433) at 2-year follow-up, noncardiac mortality was higher in the liver group (26.4% versus 14.8%; P=0.034). Lower glomerular filtration rate (hazard ratio, 1.10, for each decrease of 5 mL/min in estimated glomerular filtration rate; 95% confidence interval, 1.03–1.17; P=0.005) and Child-Pugh class B or C (hazard ratio, 3.11; 95% confidence interval, 1.47–6.56; P=0.003) were the predictors of mortality in patients with chronic liver disease, with a mortality rate of 83.2% at 2-year follow-up in patients with both factors (estimated glomerular filtration rate

Background Long‐term data on durability of currently available transcatheter heart valves are sparse. We sought to assess the incidence of long‐term (8‐year) structural valve dysfunction and bioprosthetic valve failure in a cohort of patients with transcatheter aortic valve replacement ( TAVR ) who reached at least 5‐year follow‐up. Methods and Results Consecutive patients with at least 5‐year follow‐up available undergoing TAVR from June 4, 2007 to March 30, 2012 were included. Structural valve dysfunction and bioprosthetic valve failure were defined according to newly standardized European Association of Percutaneous Cardiovascular Interventions/ European Society of Cardiology/European Association for Cardio‐Thoracic Surgery criteria and reported as cumulative incidence function to account for the competing risk of death. A total of 288 consecutive patients with a mean age of 80.7±5.3 years and with a mean Society of Thoracic Surgery mortality score of 8.1±5.1% were analyzed. Survival rate at 8 years was 29.8%. Mean pressure gradients decreased from 53.3±15.9 mm Hg (pre‐ TAVR ) to 10.5±4.5 mm Hg (in‐hospital post‐ TAVR ) ( P Bioprosthetic valve failure was observed in a total of 11 patients (8‐year cumulative incidence function: 4.51%; 95% confidence interval , 1.95%–8.76%). Severe and moderate structural valve dysfunctions were reported in 7 patients (8‐year cumulative incidence function: 2.39%; 95% confidence interval, 0.77%–5.71%) and 13 patients (8‐year cumulative incidence function: 5.87%; 95% confidence interval , 3.06%–9.96%), respectively. Aortic valve reintervention (redo TAVR ) was successfully performed in 2 patients (0.7%) presenting with symptomatic severe restenosis and intraprosthetic regurgitation subsequent to endocarditis. Conclusions In an aged population of patients with symptomatic severe aortic stenosis treated with first‐generation bioprostheses, TAVR was associated with a survival rate of 30% but low rates of bioprosthetic valve failure and structural valve dysfunction at 8 years.

Objectives: Culprit plaque characteristics in young patients who experience an Acute Coronary Syndrome (ACS) evaluated by OCT (Optical Coherence Tomography) have to be defined. The OCT-FORMIDABLE is a multicentre retrospective registry enrolling consecutive patients with ACS who performed OCT in 9 European centres. Methods: Patients were divided in two groups according to age at presentation: juvenile-ACS (age 50 years). Primary end-point was the prevalence of plaque rupture (PR). Secondary end point was the prevalence of thin cap fibro atheroma (TCFA), fibrocalcific and fibrotic plaque. Results: 285 patients were included, 71 (24.9%) in juvenile-ACS group and 215 (75.1%) in not juvenile-ACS group. Younger patients showed a trend for a higher prevalence of TCFA (70 vs. 58%, P = 0.06) and thrombus presence (62 vs. 51%, P = 0.1), while no statistical difference concerning PR (70 vs. 64%, P = 0.29). Of interest patients younger that 35 years showed a higher prevalence of PR compared to patients aged between 35 and 45 or 45 and 50 years (100 vs. 72 vs. 55%, P = 0.03). Culprit plaque in juvenile-ACS group showed more frequently a reduced mean cap thickness (119 +/- 66 vs. 155 +/- 95 nm, P = 0.05) and less frequently fibrotic (32 vs. 57%, P < 0.001) or fibrocalcific (17 vs. 36%, P = 0.003) characteristics. Conclusions:young patients with ACS show a trend for a higher prevalence of culprit PR, a thinner cap and less fibrotic or fibrocalcific components.

The aim of this study was to evaluate clinical outcomes of unprotected left main coronary artery percutaneous coronary intervention (PCI) with new-generation drug-eluting stents in a "real world" population.PCI of the unprotected left main coronary artery is currently recommended as an alternative to coronary artery bypass grafting (CABG) in selected patients.All consecutive patients with unprotected left main coronary artery stenosis treated by PCI with second-generation drug-eluting stents were analyzed in this international, all-comers, multicenter registry. The results were compared with those from the historical DELTA 1 (Drug Eluting Stent for Left Main Coronary Artery) CABG cohort using propensity score stratification. The primary endpoint was the composite of death, myocardial infarction (MI), or stroke at the median time of follow-up.A total of 3,986 patients were included. The mean age was 69.6 ± 10.9 years, diabetes was present in 30.8%, and 21% of the patients presented with acute MI. The distal left main coronary artery was involved in 84.6% of the lesions. At a median of 501 days (≈17 months) of follow-up, the occurrence of the primary endpoint of death, MI, or cerebrovascular accident was lower in the PCI DELTA 2 group compared with the historical DELTA 1 CABG cohort (10.3% vs. 11.6%; adjusted hazard ratio: 0.73; 95% confidence interval: 0.55 to 0.98; p = 0.03). Of note, an advantage of PCI was observed with respect to cerebrovascular accident (0.8% vs. 2.0%; adjusted hazard ratio: 0.37; 95% confidence interval: 0.16 to 0.86; p = 0.02), while an advantage of CABG was observed with respect to target vessel revascularization (14.2% vs. 2.9%; adjusted hazard ratio: 3.32; 95% confidence interval: 2.12 to 5.18; p 0.0001).After a median follow-up period of 17 months, PCI with new-generation drug-eluting stents was associated with an overall low rate of the composite endpoint of death, MI, or cerebrovascular accident.

Background: Overlapping implantation of bioresorbable scaffolds (BRSs) are frequent in long coronary lesions. Its impact on clinical outcomes is unknown. Objective: To compare the clinical outcomes of patients treated with overlapping BRS with those patients treated with no-overlap BRS. Methods: We analyzed the 1-year clinical outcomes of 1,477 patients treated with BRS in the GHOST-EU registry, according to the implantation of overlapping BRS. Primary endpoint was patient oriented composite endpoint (PoCE) of: all-cause death, any myocardial infarction (MI) and any repeated revascularization. Scaffold thrombosis, according to Academic Research Consortium definition, was also analyzed. Results: A total of 320 (21.7%) patients were treated with overlapping BRS (overlap group), whereas the remaining 1,157 (78.3%) received no-overlap BRS (no-overlap group). The overlap group had significantly higher frequency of male sex, diabetes mellitus, stable angina, B2/C lesion type, SYNTAX score ≥22, lesion length >34 mm, use of intracoronary imaging guidance, pre- and postdilatation. At 1-year, there were no differences in PoCE between the overlap versus no-overlap group (18.4% vs. 18.2%; HR 1.07, [0.80–1.44]; P = 0.636), even after adjustment (HR 1.05, [0.48–2.20]; P = 0.904). Scaffold thrombosis rate did not differ either at one-month (1.3% vs. 1.5%, P = 0.769) or at 1-year (1.9% vs. 2.1%, P = 0.823). Conclusions: In “Real-world” clinical practice, overlapping BRS does not appear to have an impact on clinical outcomes as compared to no-overlapping BRS. These preliminary data should be confirmed. © 2016 Wiley Periodicals, Inc.

The authors aimed to determine the procedural learning curve and minimum annual institutional volumes associated with optimum clinical outcomes for transcatheter aortic valve replacement (TAVR).Transcatheter aortic valve replacement (TAVR) is a complex procedure requiring significant training and experience for successful outcome. Despite increasing use of TAVR across institutions, limited information is available for its learning curve characteristics and minimum annual volumes required to optimize clinical outcomes.The study collected data for patients at 16 centers participating in the international TAVR registry since initiation of the respective TAVR program. All cases were chronologically ordered into initial (1 to 75), early (76 to 150), intermediate (151 to 225), high (226 to 300), and very high (300) experience operators for TAVR learning curve characterization. In addition, participating institutions were stratified by annual TAVR case volume into low-volume (50), moderate-volume (50 to 100), and high-volume (100) groups for comparative analysis. Procedural and 30-day clinical outcomes were collected and multivariate regression analysis performed for 30-day mortality and the early safety endpoint.A total of 3,403 patients comprised the study population. On multivariate analysis, all-cause mortality was significantly higher for initial (odds ratio [OR]: 3.83; 95% confidence interval [CI]: 1.93 to 7.60), early (OR: 2.41; 95% CI: 1.51 to 5.03), and intermediate (OR: 2.53; 95% CI: 1.19 to 5.40) experience groups compared with the very high experience operators. In addition, the early safety endpoint was significantly worse for all experience groups compared with the very high experience operators. Low annual volume (50) TAVR institutions had significantly higher all-cause 30-day mortality (OR: 2.70; 95% CI: 1.44 to 5.07) and worse early safety endpoint (OR: 1.60; 95% CI: 1.17 to 2.17) compared with the moderate- and high-volume groups. There was no difference in patient outcomes between intermediate and high annual volume groups.TAVR procedures display important learning curve characteristics with both greater procedural safety and a lower mortality when performed by experienced operators. In addition, TAVR performed at low annual volume (50 procedures) institutions is associated with decreased procedural safety and higher patient mortality. These findings have important implications for operator training and patient care at centers performing TAVR.