Effect of Patient-Reported Preprocedural Physical and Mental Health on 10-Year Mortality After Percutaneous or Surgical Coronary Revascularization.

BACKGROUND: Clinical and anatomical characteristics are often considered key factors in deciding between percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in patients with complex coronary artery disease (CAD) such as left-main CAD or 3-vessel disease. However, little is known about the interaction between self-reported preprocedural physical/mental health and clinical outcomes after revascularization. METHODS: This subgroup analysis of the SYNTAXES trial (SYNTAX Extended Survival), which is the extended follow-up of the randomized SYNTAX trial (Synergy Between PCI With Taxus and Cardiac Surgery) comparing PCI with CABG in patients with left-main CAD or 3-vessel disease, stratified patients by terciles of Physical (PCS) or Mental Component Summary (MCS) scores derived from the preprocedural 36-Item Short Form Health Survey, with higher PCS and MCS scores representing better physical and mental health, respectively. The primary end point was all-cause death at 10 years. RESULTS: A total of 1656 patients with preprocedural 36-Item Short Form Health Survey data were included in the present study. Both higher PCS and MCS were independently associated with lower 10-year mortality (10-point increase in PCS adjusted hazard ratio, 0.84 [95% CI, 0.73-0.97]; P=0.021; in MCS adjusted hazard ratio, 0.85 [95% CI, 0.76-0.95]; P=0.005). A significant survival benefit with CABG over PCI was observed in the highest PCS (>45.5) and MCS (>52.3) terciles with significant treatment-by-subgroup interactions (PCS Pinteraction=0.033, MCS Pinteraction=0.015). In patients with both high PCS (>45.5) and MCS (>52.3), 10-year mortality was significantly higher with PCI compared with CABG (30.5% versus 12.2%; hazard ratio, 2.87 [95% CI, 1.55-5.30]; P=0.001), whereas among those with low PCS (≤45.5) or low MCS (≤52.3), there were no significant differences in 10-year mortality between PCI and CABG, resulting in a significant treatment-by-subgroup interaction (Pinteraction=0.002). CONCLUSIONS: Among patients with left-main CAD or 3-vessel disease, patient-reported preprocedural physical and mental health status was strongly associated with long-term mortality and modified the relative treatment effects of PCI versus CABG. Patients with the best physical and mental health had better 10-year survival with CABG compared with PCI. Assessment of self-reported physical and mental health is important when selecting the optimal revascularization strategy. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; SYNTAXES Unique identifier: NCT03417050. URL: https://www. CLINICALTRIALS: gov; SYNTAX Unique identifier: NCT00114972.

Diabetes mellitus in transfemoral transcatheter aortic valve implantation: a propensity matched analysis.

BACKGROUND: Diabetes Mellitus (DM) affects a third of patients with symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI). DM is a well-known risk factor for cardiac surgery, but its prognostic impact in TAVI patients remains controversial. This study aimed to evaluate outcomes in diabetic patients undergoing TAVI. METHODS: This multicentre registry includes data of > 12,000 patients undergoing transfemoral TAVI. We assessed baseline patient characteristics and clinical outcomes in patients with DM and without DM. Clinical outcomes were defined by the second valve academic research consortium. Propensity score matching was applied to minimize potential confounding. RESULTS: Of the 11,440 patients included, 31% (n = 3550) had DM and 69% (n = 7890) did not have DM. Diabetic patients were younger but had an overall worse cardiovascular risk profile than non-diabetic patients. All-cause mortality rates were comparable at 30 days (4.5% vs. 4.9%, RR 0.9, 95%CI 0.8-1.1, p = 0.43) and at one year (17.5% vs. 17.4%, RR 1.0, 95%CI 0.9-1.1, p = 0.86) in the unmatched population. Propensity score matching obtained 3281 patient-pairs. Also in the matched population, mortality rates were comparable at 30 days (4.7% vs. 4.3%, RR 1.1, 95%CI 0.9-1.4, p = 0.38) and one year (17.3% vs. 16.2%, RR 1.1, 95%CI 0.9-1.2, p = 0.37). Other clinical outcomes including stroke, major bleeding, myocardial infarction and permanent pacemaker implantation, were comparable between patients with DM and without DM. Insulin treated diabetics (n = 314) showed a trend to higher mortality compared with non-insulin treated diabetics (n = 701, Hazard Ratio 1.5, 95%CI 0.9-2.3, p = 0.08). EuroSCORE II was the most accurate risk score and underestimated 30-day mortality with an observed-expected ratio of 1.15 in DM patients, STS-PROM overestimated actual mortality with a ratio of 0.77 and Logistic EuroSCORE with 0.35. CONCLUSION: DM was not associated with mortality during the first year after TAVI. DM patients undergoing TAVI had low rates of mortality and other adverse clinical outcomes, comparable to non-DM TAVI patients. Our results underscore the safety of TAVI treatment in DM patients. TRIAL REGISTRATION: The study is registered at clinicaltrials.gov (NCT03588247).

Genetic and RNA-related molecular markers of trastuzumab-chemotherapy-associated cardiotoxicity in HER2 positive breast cancer: a systematic review.

Cancer-therapy related cardiotoxicity (CTRCT) is a significant and frequent complication of monoclonal antibody directed therapy, especially Trastuzumab, for human epidermal growth factor receptor 2 (HER2) overexpressing breast cancers. Reliable, clinically available molecular predictive markers of CTRCT have not yet been developed. Identifying specific genetic variants and their molecular markers, which make the host susceptible to this complication is key to personalised risk stratification. A systematic review was conducted until April 2021, using the Medline, Embase databases and Google Scholar, to identify studies genetic and RNA-related markers associated with CTRCT in HER2 positive breast cancer patients. So far, researchers have mainly focused on HER2 related polymorphisms, revealing codons 655 and 1170 variants as the most likely SNPs associated with cardiotoxicity, despite some contradictory results. More recently, new potential genetic markers unrelated to the HER2 gene, and linked to known cardiomyopathy genes or to genes regulating cardiomyocytes apoptosis and metabolism, have been detected. Moreover, microRNAs are gaining increasing recognition as additional potential molecular markers in the cardio-oncology field, supported by encouraging preliminary data about their relationship with cardiotoxicity in breast cancers. In this review, we sought to synthesize evidence for genetic variants and RNA-related molecular markers associated with cardiotoxicity in HER2-positive breast cancer.

Volume of contrast to creatinine clearance ratio predicts early mortality and AKI after TAVI.

The volume of contrast to creatinine clearance ratio (CV/CrCl) is a useful indicator of the risk of acute kidney injury (AKI) in patients undergoing percutaneous interventional procedures. Association between CV/CrCl and adverse outcome after transcatheter aortic valve implantation (TAVI) was suggested but it is not well established. A large retrospective multicenter cohort of 1381 patients treated with TAVI was analyzed to assess the association between CV/CrCl and the risk of AKI and mortality at 90 days and 1 year after TAVI. Patients receiving renal replacement therapy at the time of TAVI were excluded. CV/CrCl ≥ 2.2 was associated with the risk of AKI and 90 days mortality after TAVI after adjustment for age, sex, diabetes, baseline left ventricular function, baseline chronic kidney disease (CKD), previous myocardial infarction and peripheral vascular disease (hazard ratio [HR]: 1.16, 95% confidence interval [CI]: 1.09-1.22, p < 0.0001). Importantly, CV/CrCl was associated with the adverse outcome independently from the presence of baseline CKD (p for interaction = 0.22). CV/CrCl was independently associated with the individual components of the composite primary outcome including AKI (odds ratio: 1.18, 95% CI: 1.08-1.28, p < 0.0001) and 90 days mortality (HR: 1.90, 95% CI: 1.01-3.60, p = 0.047) after TAVI. AKI (HR: 1.94, 95% CI: 1.21-3.11, p = 0.006) but not CV/CrCl was associated with the risk of 1-year mortality after TAVI. CV/CrCl is associated with excess renal damage and early mortality after TAVI. Procedural strategies to minimize the CV/CrCl during TAVI may improve early clinical outcomes in patients undergoing TAVI.

Hybrid treatment of aortic aneurism, type-A dissection, and aortic valve stenosis.

Hybrid multidisciplinary interventions are attractive care options for heart valve and vascular diseases in high-risk patients. We describe the feasibility of staged hybrid aortic arch repair to treat a type Ia endoleak and transcatheter aortic valve replacement to treat an aortic valve stenosis, achieving an escape strategy to treat an unexpected type-A aortic dissection.

Comparison of balloon-expandable vs. self-expandable valves in patients undergoing transfemoral transcatheter aortic valve implantation: from the CENTER-collaboration.

Aims: The aim of this study was to compare clinical outcomes of patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) with balloon-expandable (BE) valves vs. self-expandable (SE) valves. Transcatheter aortic valve implantation is a minimally invasive and lifesaving treatment in patients with aortic valve stenosis. Even though BE-valves and SE-valves are both commonly used on a large scale, adequately sized trials comparing clinical outcomes in patients with severe aortic valve stenosis treated with BE-valves compared with SE-valves are lacking. Methods and results: In this CENTER-collaboration, data from 10 registries or clinical trials, selected through a systematic search, were pooled and analysed. Propensity score methodology was used to reduce treatment selection bias and potential confounding. The primary endpoints were mortality and stroke at 30 days follow-up in patients treated with BE-valves compared with SE-valves. Secondary endpoints included clinical outcomes, e.g. bleeding during hospital admission. All outcomes were split for early-generation BE-valves compared with early-generation SE-valves and new-generation BE-valves with new-generation SE-valves. The overall patient population (N = 12 381) included 6239 patients undergoing TAVI with BE-valves and 6142 patients with SE-valves. The propensity matched population had a mean age of 81 ± 7 years and a median STS-PROM score or 6.5% [interquartile range (IQR) 4.0-13.0%]. At 30-day follow-up, the mortality rate was not statistically different in patients undergoing TAVI with BE-valves compared with SE-valves [BE: 5.3% vs. SE: 6.2%, relative risk (RR) 0.9; 95% confidence interval (CI) 0.7-1.0, P = 0.10]. Stroke occurred less frequently in patients treated with BE-valves (BE: 1.9% vs. SE: 2.6%, RR 0.7; 95% CI 0.5-1.0, P = 0.03). Also, patients treated with BE-valves had a three-fold lower risk of requiring pacemaker implantation (BE: 7.8% vs. SE: 20.3%, RR 0.4; 95% CI 0.3-0.4, P < 0.001). In contrast, patients treated with new-generation BE-valves more frequently experienced major and life-threatening bleedings compared with new-generation SE-valves (BE: 4.8% vs. SE: 2.1%, RR 2.3; 95% CI 1.6-3.3, P < 0.001). Conclusion: In this study, which is the largest study to compare valve types in TAVI, we demonstrated that the incidence of stroke and pacemaker implantation was lower in patients undergoing transfemoral TAVI with BE-valves compared with SE-valves. In contrast, patients treated with new-generation BE-valves more often suffered from major or life-threatening bleedings than patients with new-generation SE-valves. Mortality at 30-days was not statistically different in patients treated with BE-valves compared with SE-valves. This study was a propensity-matched analysis generated from observational data, accordingly current outcomes will have to be confirmed in a large scale randomized controlled trial.

Drug-coated balloon: Long-term outcome from a real world three-center experience.

OBJECTIVES: In-stent restenosis (ISR) and diffuse small vessel disease still represent challenging subsets for percutaneous coronary interventions, also in the new-generation DES era. We aim at reporting on the long-term clinical outcome of drug-coated balloons (DCB) in all-comers population. METHODS: Consecutive patients treated with DCB between January 2011 and December 2014 were retrospectively studied in three centers of northern Italy. The measured end-points were cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and major adverse cardiac events (MACE) defined as combination of cardiac death, MI, and TLR. RESULTS: We included 143 patients. Of the 167 lesions treated, 41 (24.5%) were de novo lesions in small coronary vessels (<2.5 mm) and 126 (75.4%) were ISR. Among ISR lesions, 78.5% were DES-ISR, 32.5% were focal, 15.8% multifocal, 30.1% diffuse, 18.2% proliferative, and 3.1% were total occlusions. Procedural success was achieved in 94.6% of cases. Overall survival free from MACEs was 91.6% at 12 months, and 75.3% at 48 months, with a total of 3 cardiac deaths, 8 MI, and 27 TLR. No thrombotic event occurred in the treated segments. There were no differences in MACESs between the ISR and de novo lesions groups. At multivariate analysis, acute coronary syndromes, previous MI, previous surgical revascularization, peripheral arterial disease and diabetes were independent predictors of MACEs at long-term follow-up. CONCLUSIONS: DCB proved a valid revascularization strategy in an all-comers population of patients with ISR and de novo lesions in small vessels, with an acceptable rate of cardiac events up to 48 months follow-up.

Intravascular lithotripsy-assisted transfemoral transcatheter aortic valve implantation after failed balloon angioplasty in patients with severe calcified peripheral artery disease.

Objectives: Calcific peripheral artery disease (PAD) is a common finding in patients scheduled for transcatheter aortic valve implantation (TAVI) and often requires iliofemoral axis preparation. However, evidence about the use of intravascular lithotripsy (IVL) in this setting is scarce. The aim of this study was to describe in-hospital and mid-term outcomes of IVL-assisted transfemoral (TF)-TAVI in patients with severe calcific PAD. Methods: The study included 13 patients with severe calcified PAD who were initially scheduled for balloon angioplasty (PTA)-assisted TF-TAVI but were eventually treated with peripheral IVL between October 2020 and February 2024. Accurate analysis of preoperative computed tomography scans revealed difficult TF access routes (severe calcified PAD with minimal lumen diameter ≤ 4.5 mm, circumferential calcification along iliofemoral axis, and marked vessels tortuosity). Results: In all cases, IVL was performed after PTA failure and allowed successful valve delivery. One patient had procedural bleeding (BARC-3a). The valve was successfully delivered without complications in 12 patients (92.3%), and no major adverse events were reported at the longest follow-up (median 18.5 months). Conclusions: IVL-assisted TF-TAVI may represent a feasible and safe option for patients presenting with severe aortic stenosis and severe calcified PAD. However, standardization of the access site severity as well as indications for a planned up-front IVL-assisted strategy are missing and require dedicated studies.

Performance of wearable watch-type home blood pressure measurement devices in a real-world clinical sample.

BACKGROUND: Independent testing of home blood pressure (BP) measurement (HBPM) devices is often lacking, particularly among older and multi-morbid patients. METHODS: We studied the Bpro G2 (using tonometry), Omron HeartGuide (using occlusive oscillometric technology), and Heartisans (using photoplethysmography) wrist watch HBPM devices against a gold standard brachial sphygmomanometer. To test device performance, we used the ISO81060-2 protocol (though this protocol cannot formally validate cuffless devices). We also used linear mixed models to compare adjusted longitudinal BP measurements between devices. Finally, as a surrogate for usability, we recorded instances of device failure where no BP measurement was returned. RESULTS: We enrolled 128 participants (median [Q1-Q3] age 53 [40-65] years, 51% male, 46% on antihypertensive drugs), of whom 100 were suitable for the primary analysis. All three devices had mean BP values within 5 mmHg of sphygmomanometry. However, due to insufficient reliability (e.g., wider than accepted standard deviations of mean BP), none of the three devices passed all criteria required by the ISO81060-2 protocol. In adjusted longitudinal analyses, the Omron device also systematically underestimated systolic and diastolic BP (- 8.46 mmHg; 95% CI 6.07, 10.86; p < 0.001; and - 2.53 mmHg; 95% CI - 4.03, - 1.03; p = 0.001; respectively). Nevertheless, compared to the Omron device, BPro and Heartisans devices had increased odds of failure (BPro: odds ratio [OR] 5.24; p < 0.0001; Heartisans: OR 5.61; p < 0.001). CONCLUSIONS: While we could not formally validate the cuffless devices, our results show that wearable technologies will require improvements to offer reliable BP assessment. This study also highlights the need for validation protocols specifically designed for cuffless BP measurement technologies.

Clinical Updates in Coronary Artery Disease: A Comprehensive Review.

Despite significant goals achieved in diagnosis and treatment in recent decades, coronary artery disease (CAD) remains a high mortality entity and continues to pose substantial challenges to healthcare systems globally. After the latest guidelines, novel data have emerged and have not been yet considered for routine practice. The scope of this review is to go beyond the guidelines, providing insights into the most recent clinical updates in CAD, focusing on non-invasive diagnostic techniques, risk stratification, medical management and interventional therapies in the acute and stable scenarios. Highlighting and synthesizing the latest developments in these areas, this review aims to contribute to the understanding and management of CAD helping healthcare providers worldwide.

Femoral Large Bore Sheath Management: How to Prevent Vascular Complications From Vessel Puncture to Sheath Removal.

Transfemoral access is nowadays required for an increasing number of percutaneous procedures, such as structural heart interventions, mechanical circulatory support, and interventional electrophysiology/pacing. Despite technological advancements and improved techniques, these devices necessitate large-bore (≥12 French) arterial/venous sheaths, posing a significant risk of bleeding and vascular complications, whose occurrence has been related to an increase in morbidity and mortality. Therefore, optimizing large-bore vascular access management is crucial in endovascular interventions. Technical options, including optimized preprocedural planning and proper selection and utilization of vascular closure devices, have been developed to increase safety. This review explores the comprehensive management of large-bore accesses, from optimal vascular puncture to sheath removal. It also discusses strategies for managing closure device failure, with the goal of minimizing vascular complications.

Coronary microvascular dysfunction in patients undergoing transcatheter aortic valve implantation.

OBJECTIVES: This study aimed to evaluate the prognostic value of coronary microvascular dysfunction (CMD) at long term after transcatheter aortic valve implantation (TAVI) and to explore its relationship with extravalvular cardiac damage (EVCD). Moreover, we sought to test the correlation between angiography-derived index of microcirculatory resistance (IMRangio) and invasive IMR in patients with aortic stenosis (AS). METHODS: This was a retrospective analysis of the Verona Valvular Heart Disease Registry (Italy) including 250 patients (83 (80-86) years, 53% female) with severe AS who underwent TAVI between 2019 and 2021. IMRangio was calculated offline using a computational flow model applied to coronary angiography obtained during the TAVI workup. CMD was defined as IMRangio ≥30 units.The primary endpoint was the composite of cardiovascular death and rehospitalisation for heart failure (HF). Advanced EVCD was defined as pulmonary circulation impairment, severe tricuspid regurgitation or right ventricular dysfunction.The correlation between IMR and IMRangio was prospectively assessed in 31 patients undergoing TAVI. RESULTS: The primary endpoint occurred in 28 (11.2%) patients at a median follow-up of 22 (IQR 12-30) months. Patients with CMD met the primary endpoint more frequently than those without CMD (22.9% vs 2.8%, p<0.0001). Patients with CMD were more frequently characterised by advanced EVCD (33 (31.4%) vs 27 (18.6%), p=0.024). CMD was an independent predictor of adverse outcomes (adjusted HR 6.672 (2.251 to 19.778), p=0.001) and provided incremental prognostic value compared with conventional clinical and imaging variables. IMRangio demonstrated fair correlation with IMR. CONCLUSIONS: CMD is an independent predictor of cardiovascular mortality and HF after TAVI.

Multivessel revascularization in non-ST segment elevation acute coronary syndromes: A systematic review and meta-analysis of 182,798 patients.

BACKGROUND: Patients experiencing non-ST segment elevation acute-coronary-syndromes (NSTE-ACS) often present with multivessel-coronary-artery-disease (MVD). An immediate complete multivessel revascularization (MVR) - within the index hospitalization - may be considered the default therapeutic strategy, although its risk-to-benefit profile has not been definitively established through dedicated clinical trials. METHODS: A systematic review and meta-analysis, adhering to MOOSE and PRISMA guidelines, was conducted to assess studies comparing immediate MVR versus a conservative culprit-only revascularization (COR) in NSTE-ACS with MVD. The main endpoints were all-cause death, major adverse cardiovascular events (MACE) and non-fatal myocardial infarction (MI). The incidence of any revascularization or further percutaneous-coronary-interventions (PCIs) were also collected. The primary analyses for the main endpoints were conducted on propensity-matched groups only. RESULTS: A total of 22 studies (182,798 patients) were identified. 7 studies, encompassing 11,372 patients, were included in the primary analysis of propensity score-matched groups. Immediate MVR significantly increased (28%) survival (OR 0.72, 95% CI 0.58-0.90, P < 0.01) along with a 35% reduction in MACE (OR 0.65, 95% CI 0.47-0.88, P = 0.01) and a 60% decrease in MI (OR 0.40, 95% CI 0.25-0.63, P < 0.01) during a mean 3-years follow-up compared to the propensity score-matched COR group. Results were consistent in the unmatched analyses. CONCLUSIONS: This meta-analysis supports an immediate MVR for improving clinical outcomes in patients with NSTE-ACS and MVD as compared to a conservative immediate COR. These data prompt further evaluations regarding optimal strategies in the pursuit of MVR, including patient selection, revascularization modality, and assessment methods of revascularization completeness.

[Drug-eluting stents in contemporary interventional practice: the STENT PANORAMA project (Part I)]. / Gli stent coronarici a rilascio di farmaco nella pratica interventistica contemporanea: progetto STENT PANORAMA (Parte I).

STENT PANORAMA is a project carried out by the Young Interventional Cardiologists of Triveneto coordinated by the Italian Society of Interventional Cardiology (GISE) Veneto delegation. The project includes two parts: the first, here reported, is aimed at describing in a standardized and easily usable way the main technological characteristics of the latest generation of the drug eluting stents (DES) that are most widely used in the Italian cath-labs. The second, to follow, will aim to summarize the main scientific evidence regarding the performance of individual devices with particular reference to subgroups of clinical interest. The ambitious goal of the STENT PANORAMA working group is to provide the interventional cardiologist with a thorough, practical, and functional knowledge of the DES currently available in the modern therapeutic armamentarium to promote a therapeutic strategy tailored to the patient.

Predicted clinical and economic burden associated with reduction in access to acute coronary interventional care during the COVID-19 lockdown in two European countries.

AIMS: As a consequence of untimely or missed revascularization of ST-elevation myocardial infarction (STEMI) patients during the COVID-19 pandemic, many patients died at home or survived with serious sequelae, resulting in potential long-term worse prognosis and related health-economic implications.This analysis sought to predict long-term health outcomes [survival and quality-adjusted life-years (QALYs)] and cost of reduced treatment of STEMIs occurring during the first COVID-19 lockdown. METHODS AND RESULTS: Using a Markov decision-analytic model, we incorporated probability of hospitalization, timeliness of PCI, and projected long-term survival and cost (including societal costs) of mortality and morbidity, for STEMI occurring during the first UK and Spanish lockdowns, comparing them with expected pre-lockdown outcomes for an equivalent patient group.STEMI patients during the first UK lockdown were predicted to lose an average of 1.55 life-years and 1.17 QALYs compared with patients presenting with a STEMI pre-pandemic. Based on an annual STEMI incidence of 49 332 cases, the total additional lifetime costs calculated at the population level were £36.6 million (€41.3 million), mainly driven by costs of work absenteeism. Similarly in Spain, STEMI patients during the lockdown were expected to survive 2.03 years less than pre-pandemic patients, with a corresponding reduction in projected QALYs (-1.63). At the population level, reduced PCI access would lead to additional costs of €88.6 million. CONCLUSION: The effect of a 1-month lockdown on STEMI treatment led to a reduction in survival and QALYs compared to the pre-pandemic era. Moreover, in working-age patients, untimely revascularization led to adverse prognosis, affecting societal productivity and therefore considerably increasing societal costs.

A randomised multicentre study of angiography- versus physiologyguided percutaneous coronary intervention in patients with coronary artery disease undergoing TAVI: design and rationale of the FAITAVI trial.

The treatment of coronary artery disease (CAD) in patients with severe aortic valve stenosis (AVS) eligible for transcatheter aortic valve implantation (TAVI) is not supported by clinical evidence, and the role of physiology over anatomy as well as the timing of coronary intervention are not defined. FAITAVI (ClinicalTrials.gov: NCT03360591) is a nationwide prospective, open-label, multicentre, randomised controlled study comparing the angiography-guided versus the physiology-guided coronary revascularisation strategy in patients with combined significant CAD and severe AVS undergoing TAVI. Significant CAD will be defined as coronary stenosis ≥50%, as assessed by visual estimation in vessels ≥2.5 mm. Physiology will be tested by fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR). The study will be conducted at 15 sites in Italy. In the angiography arm, percutaneous coronary intervention (PCI) will be performed either before TAVI, during the TAVI procedure - before or after the valve implantation - or within 1 month±5 days of the valve implantation, left to the operator's decision. In the physiology arm, FFR and iFR will be performed before TAVI, and PCI will be indicated for FFR ≤0.80, otherwise the intervention will be deferred. In case of borderline values (0.81-0.85), FFR and iFR will be repeated after TAVI, with PCI performed when needed. With a sample size of 320 patients, the study is powered to evaluate the primary endpoint (a composite of death, myocardial infarction, stroke, major bleeding, or ischaemia-driven target vessel revascularisation). TAVI indication, strategy and medical treatment will be the same in both groups. After discharge, patients will be contacted at 1, 6, 12 and 24 months after the procedure to assess their general clinical status, and at 12 months for the occurrence of events included in the primary and secondary endpoints. FAITAVI is the first randomised clinical trial to investigate "optimal" percutaneous coronary intervention associated with TAVI in patients with severe AVS and CAD.

Cerebrovascular Events in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation: A Pooled Patient-Level Study.

BACKGROUND: Cerebrovascular events remain one of the most devastating complications of transcatheter aortic valve implantation (TAVI). Data from real-world contemporary cohorts on longitudinal trends and outcomes remain limited. The aim of this study was to assess incidence, temporal trends, predictors, and outcomes of cerebrovascular events following transfemoral TAVI. METHODS AND RESULTS: The CENTER2 (Cerebrovascular Events in Patients Undergoing Transcatheter Aortic Valve Implantation With Balloon-Expandable Valves Versus Self-Expandable Valves 2) study includes patients undergoing TAVI between 2007 and 2022. The database contains pooled patient-level data from 10 clinical studies. A total of 24 305 patients underwent transfemoral TAVI (mean age 81.5±6.7 years, 56% women, median Society of Thoracic Surgeon Predicted Risk of Mortality 4.9% [3.1%-8.5%]). Of these patients, 2.2% (n=534) experienced stroke in the first 30 days after TAVI, and 40 (0.4%) had a transient ischemic attack. Stroke rates remained stable during the treatment period (2007-2010: 2.1%, 2011-2014: 2.5%, 2015-2018: 2.1%, 2019-2022: 2.1%; Ptrend=0.28). Moreover, 30-day cerebrovascular event rates were similar across Society of Thoracic Surgeon Predicted Risk of Mortality risk categories: 2.1% in low-risk, 2.6% in intermediate-risk, and 2.5% in high-risk patients (P=0.21). Mortality was higher in patients with 30-day stroke than without at 30 days (20.3% versus 4.7%; odds ratio, 5.1 [95% CI, 4.1-6.5]; P<0.001) and at 1 year (44.1% versus 15.0%; hazard ratio, 3.5 [95% CI, 3.0-4.2]; P<0.001). One-year mortality rates for stroke did not decline over time (2007-2010: 46.9%, 2011-2014: 46.0%, 2015-2018: 43.0%, 2019-2022: 39.1%; Ptrend=0.32). At 1 year, 7.0% of patients undergoing TAVI had a stroke. CONCLUSIONS: In 24 305 patients who underwent transfemoral TAVI, 30-day cerebrovascular event incidence remained ≈ 2.2% between 2007 and 2022. Thirty-day stroke rates were similar throughout Society of Thoracic Surgeon Predicted Risk of Mortality risk categories. Mortality rates after stroke remain high. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03588247.

One-year clinical outcomes of transcatheter aortic valve implantation with the latest iteration of self-expanding or balloonexpandable devices: insights from the OPERA-TAVI registry.

BACKGROUND: Midterm comparative analyses of the latest iterations of the most used Evolut and SAPIEN platforms for transcatheter aortic valve implantation (TAVI) are lacking. AIMS: We aimed to compare 1-year clinical outcomes of TAVI patients receiving Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices in current real-world practice. METHODS: Among patients enrolled in the OPERA-TAVI registry, patients with complete 1-year follow-up were considered for the purpose of this analysis. One-to-one propensity score matching was used to compare TAVI patients receiving PRO or ULTRA devices. The primary endpoint was a composite of 1-year all-cause death, disabling stroke and rehospitalisation for heart failure. Five prespecified subgroups of patients were considered according to leaflet and left ventricular outflow tract calcifications, annulus dimensions and angulation, and leaflet morphology. RESULTS: Among a total of 1,897 patients, 587 matched pairs of patients with similar clinical and anatomical characteristics were compared. The primary composite endpoint did not differ between patients receiving PRO or ULTRA devices (Kaplan-Meier [KM] estimates 14.0% vs 11.9%; log-rank p=0.27). Patients receiving PRO devices had higher rates of 1-year disabling stroke (KM estimates 2.6% vs 0.4%; log-rank p=0.001), predominantly occurring within 30 days after TAVI (1.4% vs 0.0%; p=0.004). Outcomes were consistent across all the prespecified subsets of anatomical scenarios (all pinteraction>0.10). CONCLUSIONS: One-year clinical outcomes of patients undergoing transfemoral TAVI and receiving PRO or ULTRA devices in the current clinical practice were similar, but PRO patients had higher rates of disabling stroke. Outcomes did not differ across the different anatomical subsets of the aortic root.