Evolution of right ventricular dysfunction and tricuspid regurgitation after TAVI: A prospective study.

BACKGROUND: Right ventricular (RV) dysfunction and tricuspid regurgitation (TR) may impact prognosis of patients undergoing Transcatheter Aortic Valve Implantation (TAVI). We aimed to evaluate the evolution of previous RV dysfunction and/or significant TR after TAVI procedure. METHODS: All patients undergoing TAVI between January 2018 and January 2019 were enrolled in this prospective cohort. Patients with at least one right heart (RH) abnormality at baseline including RV dysfunction (TAPSE < 17 mm, S-wave < 9.5 cm/s, Fractional area change < 35%, Strain > -20%, Tei > 0.54) and/or significant TR (Effective Regurgitant Orifice Area ≥ 40 mm2 and/or Regurgitant Volume ≥ 45 mL) underwent transthoracic echocardiography at day 1 and 6-month after TAVI. The primary endpoint was the regression of pre-TAVI RV dysfunction and/or significant TR at 6-month follow-up. RESULTS: The study enrolled 144 patients including 76 women (52.8%) with a mean age of 81.1 ± 6.8 yo, a mean EuroSCORE 2 of 5.2 ± 3.9%. At least one RH abnormality was observed in 53 patients (36.8%). At 6-month, at least one RV dysfunction parameter significantly improved in 26 patients (63.4%), TAPSE increasing from 13.0 ± 2.6 to 16.0 ± 9.8 mm, p < 0.0001 and S-wave from 7.7 ± 1.2 to 10.0 ± 2.6 cm/s, p = 0.004. Among 31 patients with baseline significant TR, TR decreased in 14 (45.2%); p = 0.003. Among patients with baseline RH abnormalities, 13 (24.5%) fully recovered. Baseline significant TR was predictive of 6-month clinical outcomes (OR = 3.1, 95%CI = [1.01-9.0], p = 0.03). CONCLUSION: In our recent intermediate surgical risk TAVI population, RV dysfunction and/or significant TR are frequent at baseline and fully or partially recover in most patients at 6-month follow-up.

Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement: Results From the DIRECTAVI Trial.

OBJECTIVES: The aim of this study was to evaluate device success of transcatheter aortic valve replacement (TAVR) using new-generation balloon-expandable prostheses with or without balloon aortic valvuloplasty (BAV). BACKGROUND: Randomized studies are lacking comparing TAVR without BAV against the conventional technique of TAVR with BAV. METHODS: DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) was an open-label noninferiority study that randomized patients undergoing TAVR using the Edwards SAPIEN 3 valve with or without prior balloon valvuloplasty. The primary endpoint was the device success rate according to Valve Academic Research Consortium-2 criteria, which was evaluated using a 7% noninferiority margin. The secondary endpoint included procedural and 30-day adverse events. RESULTS: Device success was recorded for 184 of 236 included patients (78.0%). The rate of device success in the direct implantation group (n = 97 [80.2%]) was noninferior to that in the BAV group (n = 87 [75.7%]) (mean difference 4.5%; 95% confidence interval: -4.4% to 13.4%; p = 0.02 for noninferiority). No severe prosthesis-patient mismatch or severe aortic regurgitation occurred in any group. In the direct implantation group, 7 patients (5.8%) required BAV to cross the valve. Adverse events were related mainly to pacemaker implantation (20.9% in the BAV group vs. 19.0% in the direct implantation group; p = 0.70). No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation. CONCLUSIONS: Direct TAVR without prior BAV was noninferior to the conventional strategy using BAV with new-generation balloon-expandable valves, but without procedural simplification. BAV was needed to cross the valve in a few patients, suggesting a need for upstream selection on the basis of patient anatomy. (TAVI Without Balloon Predilatation [of the Aortic Valve] SAPIEN 3 [DIRECTAVI]; NCT02729519).

Hemodynamic Performances and Clinical Outcomes in Patients Undergoing Valve-in-Valve Versus Native Transcatheter Aortic Valve Implantation.

Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) emerged has a less invasive treatment than surgery for patients with degenerated bioprosthesis. However, few data are currently available regarding results of ViV versus TAVI in native aortic valve. We aimed to compare hemodynamic performances and 1-year outcomes between patients who underwent ViV procedure and patients who underwent non-ViV TAVI. This bicentric study included all patients who underwent aortic ViV procedure for surgical bioprosthetic aortic failure between 2013 and 2017. All patients who underwent TAVI were included in the analysis during the same period. ViV and non-ViV patients were matched with 1:2 ratio according to size, type of TAVI device, age (±5 years), sex, and STS score. Primary end point was hemodynamic performance including mean aortic gradient and aortic regurgitation at 1-year follow-up. A total of 132 patients were included, 49 in the ViV group and 83 in the non-ViV group. Mean age was 82.8 ± 5.9 years, 55.3% were female. Mean STS score was 5.2% ± 3.1%. Self-expandable valves were implanted in 78.8% of patients. At 1-year follow-up, aortic mean gradient was significantly higher in ViV group (18.1 ± 9.4 mm Hg vs 11.4 ± 5.4 mm Hg; p < 0.0001) and 17 (38.6%) patients had a mean aortic gradient ≥20 mm Hg vs 6 (7.8%) in the non-ViV group (p = 0.0001). Aortic regurgitation > grade 2 were similar in both groups (p = 0.71). In the ViV group, new pacemaker implantation was less frequent (p = 0.01) and coronary occlusions occurred only in ViV group (n = 2 [4.1%]). At 1-year follow-up, 3 patients (2.3%) died from cardiac cause, 1 (2.1%) in the ViV group vs 2 (2.4%) in the non-ViV group (p = 0.9). There was no stroke. In conclusion, compared with TAVI in native aortic stenosis, ViV appears as a safe and feasible strategy in patients with impaired bioprosthesis. As 1-year hemodynamic performances seem better in native TAVI procedure, long-term follow-up should be assessed to determinate the impact of residual stenosis on outcomes and durability.

Safety of Percutaneous Coronary Intervention Without P2Y12 Inhibitor Pretreatment From a Cohort of Unselected Patients.

OBJECTIVES: Recent studies have challenged systematic pretreatment with a P2Y12 inhibitor before percutaneous coronary intervention (PCI) in elective and non-ST segment elevation myocardial infarction (NSTEMI) patients. The aim of this study was to assess outcomes after performing PCI immediately after coronary angiography with an exclusive "on-the-table" P2Y12 inhibitor loading dose, by evaluating ischemic and bleeding complications in unselected patients. METHODS: Consecutive patients admitted for elective PCI or NSTEMI were included in this two-center, prospective, observational study, and received a P2Y12 inhibitor after coronary angiography when PCI was decided. The primary composite endpoint was first occurrence of cardiovascular death, myocardial infarction, stroke, urgent revascularization, or use of bail-out glycoprotein IIb/IIIa inhibitors at 30 days after PCI. Stent thrombosis and bleeding criteria (Bleeding Academic Research Consortium [BARC]) were evaluated. RESULTS: Among 299 included patients, a total of 188 were admitted for elective PCI and 111 for NSTEMI. The incidence of the primary endpoint was 8.5% (95% confidence interval [CI], 5.7-12.4). No definite stent thrombosis occurred. Three independent predictive factors were associated with the primary endpoint: NSTEMI setting (odds ratio [OR], 5.61; 95% CI, 1.75-17.98), thrombotic coronary lesion (OR, 4.26; 95% CI, 1.45-12.54), and longer procedure duration (OR, 1.06; 95% CI, 1.03-1.09). Clinically relevant bleedings (BARC 2, 3, or 5) occurred in 5.4% of patients. CONCLUSIONS: In an unselected population admitted for elective PCI or NSTEMI in real-world clinical practice, administration of a P2Y12 inhibitor only after coronary angiography is associated with a low rate of ischemic and bleeding events at 30 days.

Prognostic Impact of Calcium Score after Transcatheter Aortic Valve Implantation Performed With New Generation Prosthesis.

Calcium score (CS) is a well-known prognostic factor after transcatheter aortic valve implantation (TAVI) performed with first generation prosthesis but few data are available concerning new generation valves. The aim of this study was to evaluate if CS remains a prognostic factor after Sapien 3 and Evolut R valves implantation. Agatston CS was evaluated on multislice computed tomography before TAVI in 346 patients implanted with Sapien XT (n = 61), CoreValve (n = 57) devices, (group 1, n = 118), and with new generation Sapien 3 (n = 147), Evolut R (n = 81) prosthesis, (group 2, n = 228). Major adverse cardiovascular events and aortic regurgitation (AR) were evaluated at 1 month. The 2 groups were similar at baseline except for logistic Euroscore (20.1% in group 1 vs 15.0 % in group 2; p = 0.001), chronic renal failure (44.1% vs 37.2% respectively, p = 0.007) and preprocedural CS (4,092 ± 2,176 vs 3,682 ± 2,109 respectively, p = 0.022). In group 1, 28 patients (23.7%) had adverse clinical events vs 21 (9.2%) in group 2 (p <0.01). In multivariate analysis, a higher CS was predictive of adverse events in group 1 (5,785 ± 3,285 vs 3,565 ± 1,331 p <0.0001) but not in group 2 (p = 0.28). A higher CS was associated with AR in group 1 (6,234 ± 2711 vs 3,429 ± 1,505; p <0.001) and in patients implanted with an Evolut R device from group 2 (4,085 ± 3,645 vs 2,551 ± 1,356; p = 0.01). In conclusion, CS appears as an important prognostic factor of major events after TAVI with first generation valves but not with new generation devices. CS remains associated with AR only with new generation self-expandable Evolut R devices.

Vascular Complications and Bleeding After Transfemoral Transcatheter Aortic Valve Implantation Performed Through Open Surgical Access.

Major vascular complications (VC) remain frequent after transcatheter aortic valve implantation (TAVI) and may be associated with unfavorable clinical outcomes. The objective of this study was to evaluate the rate of VC after transfemoral TAVI performed using an exclusive open surgical access strategy. From 2010 to 2014, we included in a monocentric registry all consecutive patients who underwent transfemoral TAVI. The procedures were performed with 16Fr to 20Fr sheath systems. VC were evaluated within 30 days and classified as major or minor according to the Valve Academic Research Consortium 2 definition. The study included 396 patients, 218 were women (55%), median age was 85 years (81 to 88), and the median logistic Euroscore was 15.2% (11 to 23). The balloon-expandable SAPIEN XT and the self-expandable Medtronic Core Valve prosthesis were used in 288 (72.7%) and 108 patients (27.3%), respectively. The total length of the procedure was 68 ± 15 minutes including 13 ± 5 minutes for the open surgical access. Major and minor VC were observed in 9 (2.3%) and 16 patients (4%), respectively, whereas life-threatening and major bleeding concerned 18 patients (4.6%). The median duration of hospitalization was 5 days (interquartile range 2 to 7), significantly higher in patients with VC (7 days [5 to 15], p <0.001). Mortality at 1-month and 1-year follow-up (n = 26, 6.6%; and n = 67, 17.2%, respectively) was not related to major or minor VC (p = 0.6). In multivariable analysis, only diabetes (odds ratio 2.5, 95% confidence interval 1.1 to 6.1, p = 0.034) and chronic kidney failure (odds ratio 3.0, 95% confidence interval 1.0 to 9.0, p = 0.046) were predictive of VC, whereas body mass index, gender, Euroscore, and lower limb arteriopathy were not. In conclusion, minimal rate of VC and bleeding can be obtained after transfemoral TAVI performed using an exclusive surgical strategy, with a particular advantage observed in high-risk bleeding patients.