Procedural and clinical outcomes of patients undergoing a TAVI in TAVI procedure: Rationale and design of the multicentre, prospective, observational ReTAVI registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is increasingly being used in younger patients and those with lower peri-procedural risk, meaning more patients will live long enough to experience structural valve deterioration (SVD) of the bioprosthesis, indicating repeated TAVI. Experience of repeated TAVI-transcatheter heart valve (THV) implantation into an index THV is limited. This registry aims to assess the peri-procedural and short-term safety, efficacy and durability of repeated TAVI. METHODS: The ReTAVI Prospective observational registry is an investigator-initiated, multicentre, international, prospective registry of patients undergoing repeated TAVI using balloon-expandable SAPIEN prosthesis to evaluate procedural and short-term safety, efficacy and durability as well as anatomical and procedural factors associated with optimal results. The registry will enrol at least 150 patients across 60 high-volume centres. Patients must be ≥18 years old, have had procedural success with their first TAVI, have index THV device failure, intend to undergo repeated TAVI and be considered suitable candidates by their local Heart Team. All patients will undergo a 30-day and 12-month follow-up. The estimated study completion is 2025. CONCLUSIONS: The registry will collect pre-, peri-, postoperative and 12-months data on patients undergoing repeated TAVI procedures with THVs for failure of the index THV and determine VARC-3-defined efficacy and safety at 30 days and functional outcome at 12 months. The registry will expand existing data sets and identify patient characteristics/indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis.

Vascular Access in Patients With Peripheral Arterial Disease Undergoing TAVR: The Hostile Registry.

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.

Periprocedural myocardial injury according to optical characteristics of neointima and treatment modality of in-stent restenosis.

AIMS: Aim of the present study was to investigate the impact of increasing neointimal inhomogeneity and neoatherosclerosis as well as of treatment modality of in-stent restenosis (ISR) on the occurrence of periprocedural myocardial injury (PMI). METHODS AND RESULTS: Patients with normal or stable/falling increased baseline high-sensitivity troponin T (hs-cTnT) undergoing intravascular optical coherence tomography (OCT) and subsequent percutaneous coronary intervention (PCI) of ISR by means of drug-coated balloon (DCB) or drug-eluting stent (DES) were included. Overall, 128 patients were subdivided into low (n = 64) and high (n = 64) inhomogeneity groups, based on the median of distribution of non-homogeneous quadrants. No significant between-group differences were detected in terms of hs-cTnT changes (28.0 [12.0-65.8] vs. 25.5 [9.8-65.0] ng/L; p = 0.355), or the incidence of major PMI (31.2 vs. 31.2%; p = 1.000). Similarly, no differences were observed between DCB- and DES-treated groups in terms of hs-cTn changes (27.0 [10.0-64.0] vs. 28.0 [11.0-73.0] ng/L; p = 0.795), or the incidence of major PMI (28.9 vs. 35.6%; p = 0.566). Additionally, no significant interaction was present between optical neointimal characteristics and treatment modality in terms of changes in hs-cTnT (Pint = 0.432). No significant differences in PMI occurrence were observed between low and high neoatherosclerosis subgroups. CONCLUSIONS: In patients undergoing PCI for ISR, there was no association between increasing neointimal inhomogeneity, or increasing expression of neoatherosclerotic changes and occurrence of PMI. PMI occurrence was not influenced by the treatment modality (DCB vs. DES) of ISR lesions, a finding that supports the safety of DCB treatment for ISR.

Prognostic implications of impaired longitudinal left ventricular systolic function assessed by tissue Doppler imaging prior to transcatheter aortic valve implantation for severe aortic stenosis.

Change in longitudinal left ventricular (LV) systolic function serves as an early marker of the deleterious effect of aortic stenosis (AS) and other cardiac comorbidities on cardiac function. We explored the prognostic value of tissue Doppler imaging (TDI)-derived longitudinal LV systolic function, defined by the peak systolic average of lateral and septal mitral annular velocities (average S') among symptomatic patients with severe AS undergoing transcatheter aortic valve implantation (TAVI). 297 consecutive patients with severe AS undergoing TAVI at three european centers with available average S' at preprocedural echocardiography were retrospectively included. The primary endpoint was the Kaplan Meier estimate of all-cause mortality. After a median 18 months (IQR 12-18) follow-up, 36 (12.1%) patients had died. Average S' was associated with all-cause mortality (per 1 cm/sec decrease: HR 1.29, 95%CI 1.03-1.60, p = 0.025), the cut-off of 6.5 cm/sec being the most accurate. Patients with average S' < 6.5 cm/sec (55.2%) presented characteristics of more advanced LV remodeling and functional impairment along with higher burden of cardiac comorbidities, and experienced higher all-cause mortality (17.6% vs. 7.5%, p = 0.007), also when adjusted for in-study outcome predictors (adj-HR: 2.69, 95%CI 1.22-5.93, p = 0.014). Results were consistent among patients with preserved ejection fraction, normal-flow AS, high-gradient AS and in those without LV hypertrophy. Longitudinal LV systolic function assessed by average S' is independently associated with long-term all-cause mortality among TAVI patients. An average S' below 6.5 cm/sec best defines clinically meaningful reduced longitudinal systolic function and may aid clinical risk stratification in these patients.