Prediction of Mortality and Heart Failure Hospitalization After Transcatheter Tricuspid Valve Interventions: Validation of TRISCORE.

BACKGROUND: Data on the prognostic role of the TRI-SCORE in patients undergoing transcatheter tricuspid valve intervention (TTVI) are limited. OBJECTIVES: The aim of this study was to evaluate the performance of the TRI-SCORE in predicting outcomes of patients undergoing TTVI. METHODS: TriValve (Transcatheter Tricuspid Valve Therapies) is a large multicenter multinational registry including patients undergoing TTVI. The TRI-SCORE is a risk model recently proposed to predict in-hospital mortality after tricuspid valve surgery. The TriValve population was stratified based on the TRI-SCORE tertiles. The outcomes of interest were all-cause death and all-cause death or heart failure hospitalization. Procedural complications and changes in NYHA functional class were also reported. RESULTS: Among the 634 patients included, 223 patients (35.2%) had a TRI-SCORE between 0 and 5, 221 (34.8%) had 6 or 7, and 190 (30%) had ≥8 points. Postprocedural blood transfusion, acute kidney injury, new atrial fibrillation, and in-hospital mortality were more frequent in the highest TRI-SCORE tertile. Postprocedure length of stay increased with a TRI-SCORE increase. A TRI-SCORE ≥8 was associated with an increased risk of 30-day all-cause mortality and all-cause mortality and the composite endpoint assessed at a median follow-up of 186 days (OR: 3.00; 95% CI: 1.38-6.55; HR: 2.17; 95% CI: 1.78-4.13; HR: 2.08, 95% CI: 1.57-2.74, respectively) even after adjustment for procedural success and EuroSCORE II or Society of Thoracic Surgeons Predicted Risk of Mortality. The NYHA functional class improved across all TRI-SCORE values. CONCLUSIONS: In the TriValve registry, the TRI-SCORE has a suboptimal performance in predicting clinical outcomes. However, a TRISCORE ≥8 is associated with an increased risk of clinical events and a lack of prognostic benefit after successful TTVI.

Transcatheter Aortic Valve Implantation to Treat Degenerated Aortic, Mitral and Tricuspid Bioprosthesis.

Transcatheter aortic valve implantation (TAVI) is now well established as the treatment of choice for patients with native aortic valve stenosis who are high or intermediate risk for surgical aortic valve replacement. Recent data has also supported the use of TAVI in patients at low surgical risk and also in anatomical subsets that were previously felt to be contra-indicated including bicuspid aortic valves and aortic regurgitation. With advancements and refinements in procedural techniques, the application of this technology has now been further expanded to include the management of degenerated bioprosthesis. After the demonstration of feasibility and safety in the management of degenerated aortic bioprosthetic valves, mitral and tricuspid bioprosthetic valve treatment is now also well-established and provides an attractive alternative to performing redo surgery. In this review, we appraise the latest clinical evidence and highlight procedural considerations when utilising TAVI technology in the management of degenerated aortic, mitral or tricuspid prosthesis.

Comparison of Mid-Term Prognosis in Intermediate-to-Low-Risk Contemporary Population with Guidelines-Oriented Age Cutoff.

BACKGROUND: Current European guidelines support transcatheter aortic valve implantation (TAVI) in intermediate-to-low-risk patients ≥75 years-old, but its prognostic relevance is unknown. METHODS: Intermediate-to-low-risk (The Society of Thoracic Surgeons score <8%) patients enrolled in the HORSE registry were included. We compared the populations aged under 75 with those over 75. The primary endpoint was all-cause mortality. RESULTS: A total of 2685 patients were included: 280 (8.6%) < 75 and 2405 ≥ 75 years. Through a mean follow-up of 437 ± 381 days, 198 (8.2%) and 23 (8.2%) patients died in the two arms without statistically significant differences (log-rank p = 0.925). At Cox regression analysis, age did not predict the occurrence of all-cause death, neither as a continuous variable (HR 1.01, 95% CI 0.99-1.04, p = 0.294) nor dichotomizing according to the prespecified cutoff of 75 years (HR 0.97, 95% CI 0.63-1.51, p = 0.924). Time-to-event ROC curves showed low accuracy of age to predict all-cause mortality (area under the curve of 0.54 for both 1-year and 2-year outcomes). CONCLUSIONS: TAVI has comparable benefits across age strata for intermediate-to-low-risk patients. The age cutoff suggested by the current guidelines is not predictive of the risk of adverse events during hospital stays or of all-cause mortality through a mid-term follow-up.

Clinical and procedural outcomes of percutaneous coronary intervention for de novo lesions involving the ostial left circumflex coronary artery.

BACKGROUND: Percutaneous treatment for ostial left circumflex artery (LCx) lesions is known to be associated with suboptimal results. AIMS: The present study aims to assess the procedural and long-term clinical outcomes of percutaneous coronary intervention (PCI) for de novo ostial LCx lesions overall and according to the coronary revascularization strategy. METHODS: Consecutive patients undergoing PCI with second generation drug eluting stents or drug coated balloons for de novo ostial LCx lesions in three high-volume Italian centers between 2012 and 2021 were retrospectively evaluated. The primary endpoint was target-vessel revascularization (TVR) at 2 years. Secondary endpoints included major adverse cardiovascular and cerebrovascular events (MACCE), target lesion revascularization, myocardial infarction, stroke, all-cause death, and repeat revascularization. RESULTS: A total of 366 patients were included in the analysis with a median follow-up of 901 (IQR: 450-1728) days. 79.5% of the patients were male, 33.6% were diabetic, 49.7% had a previous PCI, and 23.1% a prior surgical revascularization. Very ostial LCx stenting was performed in 34.1%, crossover from left main to LCx in 17.3%, and a two-stent strategy in 48.6% of cases, respectively. In the overall population, the incidence of TVR at 2 years was 19.0% while MACCE rate was 25.7%. No major differences in clinical outcomes were found according to the stenting strategy. Use of intracoronary imaging was associated with fewer MACCE (HR: 0.47, 95% CI: 0.25-1.13, p = 0.01), while the diameter of the stent implanted in the ostial LCx was associated with less TVR (HR: 0.43, 95% CI: 0.25-0.75, p = 0.002). CONCLUSIONS: Percutaneous revascularization of the ostial LCx is associated with a high rate of TVR, regardless of the stenting strategy. Intracoronary imaging and proper stent sizing may reduce the failure rates.

Drug-Coated Balloon Angioplasty for De Novo Lesions on the Left Anterior Descending Artery.

BACKGROUND: Drug-coated balloons (DCB) are an emerging tool for modern percutaneous coronary intervention (PCI), but evidence on their use for de novo lesions on large vessels is limited. METHODS: Consecutive patients undergoing DCB-based PCI on the left anterior descending artery in 2 Italian centers from 2018 to 2022 were retrospectively enrolled and compared with patients who received left anterior descending PCI with contemporary drug-eluting stents (DES). In-stent restenosis was excluded. The DCB group included both patients undergoing DCB-only PCI and those receiving hybrid PCI with DCB and DES combined. The primary end point was target lesion failure at 2 years, defined as the composite of target lesion revascularization, cardiac death, and target vessel myocardial infarction. RESULTS: We included 147 consecutive patients undergoing DCB-based treatment on the left anterior descending artery and compared them to 701 patients who received conventional PCI with DES. In the DCB group, 43 patients (29.2%) were treated with DCB only and 104 (70.8%) with a hybrid approach; DCB length was greater than stent length in 55.1% of cases. Total treated length was higher in the DCB group (65 [40-82] versus 56 [46-66] mm; P=0.002), while longer DESs were implanted (38 [24-62] versus 56 [46-66] mm; P<0.001) and a higher rate of large vessels were treated (76.2% versus 83.5%; P=0.036) in the DES cohort. The cumulative 2-year target lesion failure incidence was not significantly different between the 2 groups (DCB, 4.1% versus DES, 9.8%; hazard ratio, 0.51 [95% CI, 0.20-1.27]; P=0.15). After a 1:1 propensity score matching resulting in 139 matched pairs, the DCB-based treatment was associated with a lower risk for target lesion failure at 2 years compared with DES-only PCI (hazard ratio, 0.2 [95% CI, 0.07-0.58]; P=0.003), mainly driven by less target lesion revascularization. CONCLUSIONS: A DCB-based treatment approach for left anterior descending revascularization allows a significantly reduced stent burden, thereby potentially limiting target lesion failure risk at midterm follow-up.

Impact of design characteristics among studies comparing coronary computed tomography angiography to noninvasive functional testing in chronic coronary syndromes.

BACKGROUND: Coronary computed tomography angiography (CCTA) is widely adopted to detect obstructive coronary artery disease (CAD) in patients with chronic coronary syndromes (CCS). However, it is unknown to which extent study-specific characteristics yield different conclusions. METHODS: We summarized non-randomized and randomized studies comparing CCTA and noninvasive functional testing for CCS with information on the outcome of myocardial infarction (MI). We evaluated the differential effect according to study characteristics using random-effect meta-analysis with Hartung-Knapp-Sidik-Jonkman adjustments. RESULTS: Fifteen studies (8 non-randomized, 7 randomized) were included. CCTA was associated with decrease in relative (odds ratio (OR) 0.54, 95%CI 0.47 to 0.62, P < .001) and absolute MI risk (risk difference (RD) -0.4%, 95%CI -0.6 to -0.1, P = .005). The results remained consistent among the non-randomized (RD -0.4%, 95%CI -0.7 to -0.1, P=.029), but not among the randomized trials where there was no difference in the observed risk (RD 0.2%, 95%CI -0.6 to 0.1, P = .158). CCTA was not associated with MI reduction in studies with clinical outcome definition (OR 0.77, 95%CI 0.41 to 1.44, P = .212), research driven follow-up (OR 0.54, 95%CI 0.24 to 1.21, P = .090), central event assessment (OR 0.63, 95%CI 0.21 to 1.86, P = .207), outcome adjudication (OR 0.74, 95%CI 0.24 to 2.23, P = .178), or at low-risk of bias (OR 0.74, 95%CI 0.24 to 2.23, P = .178). CONCLUSIONS: Among studies of any design, CCTA was associated with lower risk of MI in CCS compared to noninvasive functional testing. This benefit was diminished among studies with clinical outcome definition, central outcome assessment/adjudication or at low-risk of bias.

Symptoms-to-emergency-call timing delay in acute coronary syndrome before and during COVID-19: independent predictors and their impact on mortality.

BACKGROUND: The COVID-19 pandemic severely impacted global health. The aim of this study was to compare predictors of symptoms-to-emergency-call timing delay in acute coronary syndrome (ACS) and their impact on mortality before and during the COVID-19 outbreak. METHODS: We collected sociodemographic, clinical data, procedural features, preadmission and intra-hospital outcomes of consecutive patients admitted for ACS in seventeen Italian centers from March to April 2018, 2019, and 2020. RESULTS: In 2020, a 32.92% reduction in ACS admissions was observed compared to 2018 and 2019. Unstable angina, typical and atypical symptoms, and intermittent angina were identified as significant predictors of symptoms-to-emergency-call timing delay before and during the COVID-19 pandemic (P<0.005 for all the items). Differently from 2018-2019, during the pandemic, hypertension and dyspnea (P=0.002 versus P=0.490 and P=0.001 vs. P=0.761 for 2018-2019 and 2020, respectively) did not result as predictors of delay in symptoms-to-emergency-call timing. Among these predictors, only the atypical symptoms (HR 3.36; 95% CI: 1.172-9.667, P=0.024) in 2020 and the dyspnea (HR 2.64; 95% CI: 1.345-5.190, P=0.005) in 2018-2019 resulted significantly associated with higher mortality. Finally, the family attendance at the onset of the symptoms resulted in a reduction in symptoms-to-emergency-call timing (in 2020 P<0.001; CI: -1710.73; -493.19) and in a trend of reduced mortality (HR 0.31; 95% CI: 0.089-1.079, P=0.066) in 2020. CONCLUSIONS: During the COVID-19 outbreak, atypical symptoms and family attendance at ACS onset were identified, respectively, as adverse and favorable predictors of symptoms-to-emergency-call timing delay and mortality.

Long Stent Implantation on the Left Anterior Descending Coronary Artery at a Follow-Up of More Than Five Years.

BACKGROUND: Stent implantation represents the standard of care in coronary intervention. While a short stent implanted on a focal lesion located on the left anterior descending artery (LAD) seems a reasonable alternative to an internal mammary implant, the same for long stents is still debated. METHODS: We reported the long-term data of 531 consecutive patients who underwent Percutaneous Coronary Intervention (PCI) with long stents in two highly specialized centres. The main inclusion criteria were the implantation of stents longer than 30 mm on the LAD and a minimum follow-up (FU) of five years. The primary endpoint was mortality, and the secondary endpoints were any myocardial infarction (MI), target vessel and lesion revascularization (TVR and TLR, respectively), and stent thrombosis (ST) observed as definite, probable, or possible. RESULTS: In this selected population with characteristics of complex PCI (99.1%), the long-term follow-up (mean 92.18 ± 35.5 months) estimates of all-cause death, cardiovascular death, and any myocardial infarction were 18.3%, 10.5%, and 9.3%, respectively. Both all-cause and cardiovascular deaths are significantly associated with three-vessel disease (HR 6.8; confidence of interval (CI) 95% 3.844-11.934; p < 0.001, and HR 4.7; CI 95% 2.265-9.835; p < 0.001, respectively). Target lesion (TLR) and target vessel revascularization (TVR) are associated with the presence of three-lesion disease on the LAD (HR 3.4; CI 95% 1.984-5.781; p < 0.001; HR 3.9 CI 95% 2.323-6.442; p < 0.001, respectively). Re-PCI for any cause occurred in 31.5% of patients and shows an increased risk for three-lesion stenting (HR 4.3; CI 95% 2.873-6.376; p < 0.001) and the treatment of bifurcation with two stents (HR 1.6; 95% CI 1.051-2.414; p = 0.028). Stent thrombosis rate at the 5-year FU was 4.4% (1.3% definite; 0.9% probable; 2.1% possible), including a 1.7% rate of very-late thrombosis. The stent length superior to 40 mm was not associated with poor outcomes (all-cause death p = 0.349; cardiovascular death p = 0.855; MI p = 0.691; re-PCI p = 0.234; TLR p = 0.805; TVR p = 0.087; ST p = 0.189). CONCLUSION: At an FU of longer than five years, patients treated with stents longer than 30 mm in their LAD showed acceptable procedural results but poor outcomes.

Coronary access following ACURATE neo implantation for transcatheter aortic valve-in-valve implantation: Ex vivo analysis in patient-specific anatomies.

Background: Coronary access after transcatheter aortic valve implantation (TAVI) with supra-annular self-expandable valves may be challenging or un-feasible. There is little data concerning coronary access following transcatheter aortic valve-in-valve implantation (ViV-TAVI) for degenerated surgical bioprosthesis. Aims: To evaluate the feasibility and challenge of coronary access after ViV-TAVI with the supra-annular self-expandable ACURATE neo valve. Materials and methods: Sixteen patients underwent ViV-TAVI with the ACURATE neo valve. Post-procedural computed tomography (CT) was used to create 3D-printed life-sized patient-specific models for bench-testing of coronary cannulation. Primary endpoint was feasibility of diagnostic angiography and PCI. Secondary endpoints included incidence of challenging cannulation for both diagnostic catheters (DC) and guiding catheters (GC). The association between challenging cannulations with aortic and transcatheter/surgical valve geometry was evaluated using pre and post-procedural CT scans. Results: Diagnostic angiography and PCI were feasible for 97 and 95% of models respectively. All non-feasible procedures occurred in ostia that underwent prophylactic "chimney" stenting. DC cannulation was challenging in 17% of models and was associated with a narrower SoV width (30 vs. 35 mm, p < 0.01), STJ width (28 vs. 32 mm, p < 0.05) and shorter STJ height (15 vs. 17 mm, p < 0.05). GC cannulation was challenging in 23% of models and was associated with narrower STJ width (28 vs. 32 mm, p < 0.05), smaller transcatheter-to-coronary distance (5 vs. 9.2 mm, p < 0.05) and a worse coronary-commissural overlap angle (14.3° vs. 25.6 o , p < 0.01). Advanced techniques to achieve GC cannulation were required in 22/64 (34%) of cases. Conclusion: In this exploratory bench analysis, diagnostic angiography and PCI was feasible in almost all cases following ViV-TAVI with the ACURATE neo valve. Prophylactic coronary stenting, higher implantation, narrower aortic sinus dimensions and commissural misalignment were associated with an increased challenge of coronary cannulation.

The Incidence and Impact of In-Hospital Bleeding in Patients with Acute Coronary Syndrome during the COVID-19 Pandemic.

BACKGROUND: The COVID-19 pandemic increased the complexity of the clinical management and pharmacological treatment of patients presenting with an Acute Coronary Syndrome (ACS). AIM: to explore the incidence and prognostic impact of in-hospital bleeding in patients presenting with ACS before and during the COVID-19 pandemic. METHODS: We evaluated in-hospital Thrombolysis In Myocardial Infarction (TIMI) major and minor bleeding among 2851 patients with ACS from 17 Italian centers during the first wave of the COVID-19 pandemic (i.e., March-April 2020) and in the same period in the previous two years. RESULTS: The incidence of in-hospital TIMI major and minor bleeding was similar before and during the COVID-19 pandemic. TIMI major or minor bleeding was associated with a significant threefold increase in all-cause mortality, with a similar prognostic impact before and during the COVID-19 pandemic. CONCLUSIONS: the incidence and clinical impact of in-hospital bleeding in ACS patients was similar before and during the COVID-19 pandemic. We confirmed a significant and sizable negative prognostic impact of in-hospital bleeding in ACS patients.

Prediction of type 4a myocardial infarction with the angiography-derived hemodynamic (ADDED) index.

Percutaneous coronary intervention (PCI) is frequently complicated by type 4a myocardial infarction (MI), which is associated with an increased risk of mortality. We assessed the usefulness of the angiography-derived hemodynamic index (ADDED), which is based on the extent of myocardium at risk and on the anatomical lesion severity, in predicting type 4a MI in patients with chronic coronary syndrome (CCS) undergoing PCI. We enrolled 442 patients treated with single-vessel PCI. The ADDED index was calculated as the ratio of the Duke Jeopardy Score to the minimum lumen diameter assessed with quantitative angiography analysis. Type 4a MI was defined according to the 4th Universal Definition of MI. The overall population was divided into tertiles of ADDED index. Type 4a MI occurred in 5 patients (3.3%) in the ADDED-low tertile, 8 (5.5%) in the ADDED-mid tertile, and 26 (17.7%) in the ADDED-high tertile (p < 0.0001). At ROC curve analysis, the ADDED index could significantly discriminate between patients with and without type 4a MI (area under the curve 0.745). At multivariate analysis, an ADDED index value > 5.25 was the strongest independent predictor type 4a MI. Our results support the role of the ADDED index as a predictor of type 4a MI in patients with CCS treated with elective PCI of a single vessel. Whether a selective use of additional preventive measures in patients considered at high risk based on ADDED index values may improve peri-procedural and long-term outcomes remains to be tested in dedicated investigations.

Platelet reactivity and clinical outcomes following percutaneous coronary intervention in complex higher-risk patients.

AIMS: To investigate the levels of platelet reactivity and the impact of high platelet reactivity (HPR) on long-term clinical outcomes of complex higher-risk and indicated patients (CHIP) with stable coronary artery disease (CAD) treated with elective percutaneous coronary intervention (PCI). METHODS: We enrolled 500 patients undergoing elective PCI for stable CAD and treated with aspirin and clopidogrel. Patients were divided into four groups based on the presence of CHIP features and HPR. Primary endpoint was the occurrence of major adverse clinical events (MACE) at 5 years. RESULTS: The prevalence of HPR was significantly greater in the CHIP population rather than non-CHIP patients (39.9% vs 29.8%, P = 0.021). Patients with both CHIP features and HPR showed the highest estimates of MACE (22.1%, log-rank P = 0.047). At Cox proportional hazard analysis, the combination of CHIP features and HPR was an independent predictor of MACE (hazard ratio 2.57, 95% confidence interval 1.30-5.05, P = 0.006). CONCLUSION: Among patients with stable CAD undergoing elective PCI and treated with aspirin and clopidogrel, the combination of CHIP features and HPR identifies a cohort of patients with the highest risk of MACE at 5 years, who might benefit from more potent antiplatelet strategies.