Impact of leaflet splitting on coronary access after redo-TAVI for degenerated supra-annular self-expanding platforms.

BACKGROUND: Coronary access (CA) is a major concern in redo-transcatheter aortic valve implantation (TAVI) for failing supra-annular self-expanding transcatheter aortic valves (TAVs). AIMS: This ex vivo study evaluated the benefit of leaflet splitting (LS) on subsequent CA after redo-TAVI in anatomies deemed at high risk of unfeasible CA. METHODS: Ex vivo, patient-specific models were printed three-dimensionally. Index TAVI was performed using ACURATE neo2 or Evolut PRO (TAV-1) at the standard implant depth and with different degrees of commissural misalignment (CMA). Redo-TAVI was performed using the balloon-expandable SAPIEN 3 Ultra (TAV-2) at different implant depths with commissural alignment. Selective CA was attempted for each configuration before and after LS in a pulsatile flow simulator. The leaflet splay area was assessed on the bench. RESULTS: In matched comparisons of 128 coronary cannulations across 64 redo-TAVI configurations, the overall feasibility of CA significantly increased after LS (60.9% vs 18.7%; p<0.001). The effect of LS varied according to the sinotubular junction height, TAV-1 design, TAV-1 CMA, and TAV-2 implant depth, given TAV-2 alignment. LS enabled CA for up to CMA 45° with the ACURATE neo2 TAV-1 and up to CMA 30° with the Evolut PRO TAV-1. The combination of LS and a low TAV-2 implant provided the highest feasibility of CA after redo-TAVI. The leaflet splay area ranged from 25.60 mm2 to 37.86 mm2 depending on the TAV-1 platform and TAV-2 implant depth. CONCLUSIONS: In high-risk anatomies, LS significantly improves CA feasibility after redo-TAVI for degenerated supra-annular self-expanding platforms. Decisions on redo-TAVI feasibility should be carefully individualised, taking into account the expected benefit of LS on CA for each scenario.

Sex Differences in Outcomes After Percutaneous Coronary Intervention or Coronary Artery Bypass Graft for Left Main Disease: From the DELTA Registries.

Background Controversy exists over whether sex has significant interaction with revascularization strategy for unprotected left main coronary artery disease. Higher mortality has been reported among women treated with percutaneous coronary intervention compared with coronary artery bypass grafting. Methods and Results The DELTA (Drug-Eluting Stents for Left Main Coronary Artery Disease) and DELTA-2 registries are international, multicentric registries evaluating the outcomes of subjects undergoing coronary revascularization for unprotected left main coronary artery disease. The primary outcome was a composite of death, myocardial infarction, or cerebrovascular accidents. The population consisted of 6253 patients, including 1689 (27%) women. Women were older and more likely to have diabetes and chronic kidney disease than men (P<0.05). At a median follow-up of 29 months (interquartile range 12-49), a significant interaction between sex and revascularization strategy was observed for the primary end point (pint=0.012) and all-cause death (pint=0.037). Among women, compared with percutaneous coronary intervention, coronary artery bypass grafting was associated with lower risk of the primary end point (event rate 9.5% versus 15.3%; adjusted hazard ratio [AHR], 0.53; 95% CI, 0.35-0.79, P<0.001) and all-cause death (event rate 5.6% versus 11.7% AHR, 0.50; 95% CI, 0.30-0.82) and no significant differences were observed in men. Conclusions In women undergoing coronary revascularization for unprotected left main coronary artery disease, coronary artery bypass grafting was associated with lower risk of death, myocardial infarction, or cerebrovascular accidents whereas no significant differences between coronary artery bypass grafting and percutaneous coronary intervention were observed in men. Further dedicated studies are needed to determine the optimal revascularization strategy in women with unprotected left main coronary artery disease.

Patients younger than 70 undergoing transcatheter aortic valve implantation: Procedural outcomes and mid-term survival.

INTRODUCTION: Based on recent data, the indication for transcatheter aortic valve implantation (TAVI) is expanding to individuals at lower surgical risk, who are generally younger than subjects historically treated for severe aortic stenosis. Indeed, younger patients have traditionally been under-represented in current TAVI literature. The aim of the present study is to report about clinical features, procedural outcomes and mid-term outcomes of patients younger than 70 who underwent TAVI in a single high-volume center. MATERIALS AND METHODS: Consecutive patients younger than 70 years of age who underwent TAVI for severe, symptomatic aortic stenosis between 2007 and 2019 at a single, tertiary referral center have been included in this retrospective study. Procedural and mid-term outcomes were analyzed, comparing 1st generation with 2nd generation devices. RESULTS: Between 2007 and 2019, 1740 TAVI procedures were performed in our center. Among these, one hundred twenty-nine (7.4%) patients were younger than 70 years at the time of the intervention and were included in the present analysis. Fifty-eight patients (45%) were implanted with a 1st generation prosthesis while seventy-one patients (55%) were implanted with a 2nd generation device. Reasons which lead to a transcatheter approach in this population were: previous CABG (27.9%); porcelain aorta (24%); severe left ventricular systolic dysfunction (21.7%); prior chest radiation (19.4%); severe lung disease (8.5%); hemodynamic instability (7.0%); advanced liver disease (4.6%) and active cancer (3.9%). Overall device success rate was 89%, with no differences among 1st and 2nd generation devices. Threeyears all-cause mortality was 34%, with no difference among the two groups. Low incidence of aortic-valve re-intervention was observed at mid-term follow-up (late valve re-intervention = 2.3%). CONCLUSIONS: TAVI in young patient with appropriate indication for intervention is a safe procedure, associated with low rate of in hospital mortality and low rate of severe complications both with 1st and with 2nd generation devices. When considering long term durability, more data are needed; in our case series long-term follow up shows a good survival and also an extremely low rate of valve re-intervention.

Mitral valve surgery after a failed MitraClip procedure.

OBJECTIVES: Among patients undergoing transcatheter mitral valve repair with the MitraClip device, a relevant proportion (2-6%) requires open mitral valve surgery within 1 year after unsuccessful clip implantation. The goal of this review is to pool data from different reports to provide a comprehensive overview of mitral valve surgery outcomes after the MitraClip procedure and estimate in-hospital and follow-up mortality. METHODS: All published clinical studies reporting on surgical intervention for a failed MitraClip procedure were evaluated for inclusion in this meta-analysis. The primary study outcome was in-hospital mortality. Secondary outcomes were in-hospital adverse events and follow-up mortality. Pooled estimate rates and 95% confidence intervals (CIs) of study outcomes were calculated using a DerSimionian-Laird binary random-effects model. To assess heterogeneity across studies, we used the Cochrane Q statistic to compute I2 values. RESULTS: Overall, 20 reports were included, comprising 172 patients. Mean age was 70.5 years (95% CI 67.2-73.7 years). The underlying mitral valve disease was functional mitral regurgitation in 50% and degenerative mitral regurgitation in 49% of cases. The indication for surgery was persistent or recurrent mitral regurgitation (grade >2) in 93% of patients, whereas 6% of patients presented with mitral stenosis. At the time of the operation, 80% of patients presented in New York Heart Association functional class III-IV. Despite favourable intraoperative results, in-hospital mortality was 15%. The rate of periprocedural cerebrovascular accidents was 6%. At a mean follow-up of 12 months, all-cause death was 26.5%. Mitral valve replacement was most commonly required because the possibility of valve repair was jeopardized, likely due to severe valve injury after clip implantation. CONCLUSIONS: Surgical intervention after failed transcatheter mitral valve intervention is burdened by high in-hospital and 1-year mortality, which reflects reflecting the high-risk baseline profile of the patients. Mitral valve replacement is usually required due to leaflet injury.

Meta-Analysis Comparing P2Y12 Inhibitors in Acute Coronary Syndrome.

Dual antiplatelet therapy combining aspirin with a P2Y12-receptor inhibitor reduces atherothrombotic events following an acute coronary syndromes (ACS), but the relative merits of different P2Y12 inhibitors remain unclear, despite several recent large-scale trials. We performed a network meta-analysis, representing the largest evidence to date to inform P2Y12 inhibitor choice in patients with ACS. Fourteen studies were included, for a total population of 145,019 patients. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were used in this systematic review. A network meta-analysis using a frequentist approach with surface under the cumulative ranking probability calculation was performed. Major adverse cardiovascular events (MACE), all-cause death, myocardial infarction (MI), definite stent thrombosis (ST) and major bleeding at 30-day and 1-year all-cause death and MI were the study endpoints. At 30-day, prasugrel was superior to both clopidogrel and ticagrelor in MACE, all-cause death and definite ST endpoints. Both prasugrel and ticagrelor were superior to clopidogrel in MI endpoint. Ticagrelor also reduced all-cause death compared with clopidogrel. Ticagrelor, prasugrel, and clopidogrel resulted equivalent in terms of the safety outcome of 30-day major bleeding. No significant difference was found among clopidogrel, prasugrel, and ticagrelor with respect to 1-year MACE outcome. Both prasugrel and ticagrelor reduced the occurrence of 1-year all-cause death compared with clopidogrel. Prasugrel reduced 1-year MI rate as compared with clopidogrel, while ticagrelor did not. At probability analyses, prasugrel ranked best in all 30-day and 1-year efficacy and safety endpoints. In conclusion, in this network meta-analysis, prasugrel showed the highest efficacy in reducing adverse outcomes in ACS patients and had the highest probability of being the best P2Y12 inhibitor to reduce hard adverse events both at 30-day and 1-year follow-up.

Rotational atherectomy-based percutaneous coronary intervention and the risk of contrast-induced nephropathy.

BACKGROUND: Rotational atherectomy (RA)-related complications (e.g., no-reflow and perforation) may be associated with increased risk of contrast-induced nephropathy (CIN), causing hypotension, acute heart failure, and periprocedural myocardial infarction. Our aim was to evaluate the incidence of CIN in patients undergoing RA-based vs. non-RA-based percutaneous coronary intervention (PCI). METHODS: This single-center retrospective registry included all patients who underwent PCI between 2012 and 2016 for whom post-procedural creatinine was determined. Study endpoint was CIN, defined as an increase of serum creatinine ≥0.3 mg/dL or ≥50% from baseline within 72 h post-PCI. Propensity score matching (PSM) was performed to account for selection bias between RA and non-RA patients. RESULTS: Study population included 2580 patients: 70 (3%) had RA PCI and 2510 (97%) had non-RA PCI. Following PSM, there were 70 patients in RA and 280 patients in non-RA group with good overall adjustment between groups, although RA patients received larger contrast volume (263±126 vs. 224±118 mL, P=0.01) and showed higher Mehran risk score at baseline (11.1±6.6 vs. 8.9±4.8, P=0.01). The incidence of CIN was similar between RA and non-RA patients (15.7% vs. 13.2%, P=0.59). New need for dialysis was required in 0% vs. 0.7% patients, respectively (P=0.48). On multivariate analysis, RA PCI was not independently associated with development of CIN. CONCLUSIONS: Despite being performed in patients with a higher burden of comorbidities and with larger volumes of contrast, RA PCI is not associated with higher risk of CIN, compared with PCI in non-RA patients.

Thrombotic Risk and Antithrombotic Strategies After Transcatheter Mitral Valve Replacement.

Severe mitral regurgitation (MR) is fairly common in the general population and is associated with significant morbidity and mortality. Although surgical mitral valve (MV) repair and replacement are well established treatment options for MV disease, as much as one-half of patients with severe, symptomatic MR are not referred for surgery due to prohibitive procedural risk. Novel transcatheter alternatives are therefore being developed to provide an alternative treatment for these patients. A growing experience with transcatheter MV replacement (TMVR) strategies is accumulating and promising early results have been reported. However, the risk of transcatheter heart valve (THV) thrombosis seems to be relevant after TMVR, potentially higher than that observed after transcatheter aortic valve replacement, and routine anticoagulant therapy appears to be necessary to mitigate this risk. Hereafter, the authors: 1) review available evidence on thrombotic risk after TMVR (including new dedicated THVs for native MV, valve-in-valve, valve-in-ring, and valve-in-mitral annular calcification); and 2) discuss the antithrombotic treatment strategies after TMVR.

Risk of contrast-induced nephropathy in patients undergoing complex percutaneous coronary intervention.

BACKGROUND: Complex percutaneous coronary intervention (PCI) is associated with increased procedural challenges and high contrast load. We aimed to evaluate the association between complex PCI and contrast-induced nephropathy (CIN). METHODS: This single-center retrospective study included all-comers undergoing PCI between January 2012 and December 2016. Complex PCI was defined as a procedure with ≥1 of the following characteristics: 3 vessels treated, ≥3 stents implanted, two-stent bifurcation intervention, total stent length >60 mm, PCI on a chronic total occlusion, saphenous vein graft, or left main, protected PCI, use of rotational/laser atherectomy. CIN was defined as an increase in post-PCI creatinine of ≥0.3 mg/dl or ≥50% from baseline. RESULTS: We included 2660 patients (n = 1128 complex PCI, n = 1532 non-complex PCI). Complex PCI patients tended to be older, and had higher cardiovascular comorbidity and Mehran CIN risk score. They also had a higher prevalence of type B2/C lesions and need for mechanical circulatory support, and received a higher mean contrast volume (284 ±â€¯137 vs. 189 ±â€¯90 ml, p < 0.001). CIN incidence was similar in complex vs. non-complex PCI patients (12.1% vs. 11.5%, p = 0.63), as was the need for in-hospital dialysis (0.5% vs. 0.2%, p = 0.25). Upon multivariable adjustment, age, female sex, diabetes, ejection fraction, periprocedural hypotension, presentation with acute coronary syndrome, and contrast volume were independently associated with CIN, while complex PCI was not. CONCLUSIONS: Complex PCI is not associated with an increased risk of CIN in all-comers. Further studies should confirm our findings and investigate novel effective strategies to decrease the risk of this serious complication.

One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in patients needing short dual antiplatelet therapy. Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry).

BACKGROUND: This study aimed to evaluate real-world clinical outcome of patients needing short dual antiplatelet therapy (S-DAPT) following PCI with Ultimaster® thin-strut, biodegradable polymer sirolimus-eluting stent (BP-SES), which was supposed to induce faster stent endothelialization and reduce device thrombogenicity. METHODS: In this sub-group analysis of patients enrolled in the ULISSE registry, two groups were identified: 1) patients discharged with S-DAPT (≤3-month) due to high bleeding risk or need for urgent major non-cardiac surgery and 2) patients discharged with recommended DAPT (R-DAPT) duration (≥6-month). The primary ischemic-safety and bleeding-safety endpoints were TLF (composite of cardiac-death, target vessel MI, and clinically driven target lesion revascularization), and BARC major bleedings (≥type-3a) at 1-year follow-up. To account for events occurring before DAPT discontinuation we performed 3-month landmark analysis. RESULTS: 82 patients (5%) were discharged with ≤3-month DAPT (57 ±â€¯27 days), and 1558 patients (94%) were discharged with ≥6-month DAPT (318 ±â€¯75 days). No significant differences between S-DAPT and R-DAPT group were observed in TLF at 1-year (7.9% vs. 4.6%). The rate of BARC major bleeding resulted significantly higher in S-DAPT group (3.9% vs. 0.3%; p = 0.001), with the majority of bleeding events occurring within 3 months. The landmark analysis showed no significant differences in BARC major bleedings between groups (1.4% vs. 0.3%; p = 0.142). CONCLUSIONS: As compared to those treated with R-DAPT (≥6-month), patients needing -S-DAPT (≤3-month) after PCI with Ultimaster® BP-SES had similar rates of 1-year TLF and BARC major bleedings following early DAPT discontinuation.

Contrast-Induced Nephropathy After Percutaneous Coronary Intervention for Chronic Total Occlusion Versus Non-Occlusive Coronary Artery Disease.

Contrast volume is associated with the incidence of contrast-induced nephropathy (CIN), and CIN risk could be particularly high in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Our aim was to evaluate the incidence of CIN in patients who underwent CTO versus non-CTO PCI. All PCIs performed at our institution from January 2012 to December 2016 were included in this study. CIN was defined as an increase of ≥0.3 mg/dl or ≥50% from baseline within 72 hours. Multivariable logistic regression analysis was performed to identify independent predictors of CIN. A total of 2,580 patients were included (n = 309 CTO PCI and n = 2271 non-CTO PCI). Estimated glomerular filtration rate was lower in the non-CTO group (73.9 ± 27.3 vs 77.1 ± 24.7 ml/min/1.73/m2, p = 0.05). Patients in the non-CTO PCI group presented more often with acute coronary syndrome (47% vs 15%, p < 0.001). Contrast volume (347 ± 159 vs 215 ± 107 ml, p < 0.001) and contrast-volume-to-creatinine-clearance ratio (4.7 ± 2.1 vs 3.2 ± 1.8, p < 0.001) were higher in the CTO group. There was no difference in CIN rates between CTO and non-CTO groups (9.4% vs 12.1%, p = 0.17). This was confirmed in a sensitivity analysis including only patients who underwent PCI in a stable clinical setting (7.7% vs 8.5%, p = 0.66). On multivariate analysis hypotension during/before PCI (odds ratio [OR] 2.86), acute coronary syndrome (OR 1.86), age (OR 1.54), female sex (OR 1.51), left ventricular ejection fraction (OR 0.64), diabetes mellitus (OR 1.49), and contrast volume (OR 1.17) were independent predictors of CIN, while CTO PCI was not. In conclusion, CTO PCI is associated with similar rates of CIN, compared with non-CTO PCI. These findings persisted on sensitivity and multivariable analyses.

Two-year cardiac mortality after MitraClip treatment of functional mitral regurgitation in ischemic and non-ischemic dilated cardiomyopathy.

BACKGROUND: MitraClip implantation has evolved as a new tool for treatment of inoperable or high-risk patients with severe functional mitral regurgitation (FMR) due to dilated cardiomyopathy (DCM). Limited data are available regarding MitraClip outcomes comparing patients with ischemic and non-ischemic DCM. METHODS: From 2008 to 2016, 314 patients received MitraClip for FMR at four institutions: Brescia, Zurich and Milan. Patients were stratified according to MR aetiology in non-ischemic FMR (n = 99) and ischemic FMR (n = 215). Preoperative risk factors, operative variables and outcomes up to 2-year were evaluated. A multivariable Cox Proportional Hazards survival model with covariate adjustments was used to assess the relationship between FMR aetiology and 2-year cardiac mortality. RESULTS: As expected, patients with ischemic FMR had significantly more risk factors and comorbidities. Overall procedural success rate was 80% and in-hospital cardiac mortality was 3% without significant differences between aetiology. Two-year overall (25% vs. 19%, p = 0.574) and cardiac (18% vs. 16%, p = 0.990) mortality rates were comparable. No differences were detected in terms of re-hospitalization rates (32%), LVAD implantation (4.5%) and mitral valve surgery (1%). LVEF ≤ 25%, LVEDV > 216 ml, NT-proBNP ≥ 10.000 pg/ml and AF were the strongest baseline predictors of 2-year cardiac mortality. Greater improvements of 6MWT and NYHA functional class were observed in patients with non-ischemic FMR. CONCLUSIONS: The ischemic or non-ischemic aetiology of DCM did not affect in-hospital and 2-year cardiac mortality after MitraClip in patients with FMR. In case of unfavorable baseline clinical condition, the indication for MitraClip should be carefully weighed in favour of conservative medical therapy alone or left ventricular assist device.