Introduction
Despite of the wide evidence of use fractional flow reserve (FFR), isolated angiography evaluation is still the main tool to indicate percutaneous coronary intervention. Quantitative ...flow ratio (QFR) is a new functional index to assess functional significance. Recently, few studies have showed the capacity of QFR to predict significance stenosis. The aim of this research has been to describe the evidence of QFR in this clinical setting, to analyze the global diagnosis accuracy of QFR versus FFR and to compare the difference in feasibility between retrospective and prospective analysis.
Methods and results
Systematic review of literature was performed. Eligible studies for the meta‐analysis were considered those directly evaluating de QFR versus FFR. Pooled values of diagnosis test and summary receiver operator curve were calculated. Main causes of not‐perform QFR analysis according to study design were also evaluated.
Sixteen studies were included. Good correlation and agreement were showed. Global sensibility, specificity, PPV, and NPV were 0.84, 0.89, 0.80, and 0.92, respectively. Then, 18% of evaluated vessels could not be analyzed. Significant differences were found in the percentage of discarded vessels and the cause of nonperformed analysis between retrospective or prospective analysis.
Conclusions
Excellent correlation and agreement between QFR and FFR was demonstrated. QFR assessment could be improved by its prospective analysis with a dedicated protocol.
Aims
Empirically, transfemoral (TF) approach is the first choice for transcatheter aortic valve implantation (TAVI). We aimed to investigate whether transubclavian (TSc) and TF approaches present ...comparable major outcomes according to current evidence.
Methods
We systematically searched PubMed, EMBASE, and Cochrane database for studies with symptomatic aortic stenosis patients who underwent TAVI through TF or TSc/axillary access from January/2006 to January/2017. Searched terms were: (“aortic stenosis” OR “transcatheter aortic” OR “TAVI” OR “TAVR”) and (“transfemoral” OR “transaxillary” OR “transubclavian”). Major outcomes according to Valve Academic Research Consortium‐2 criteria were gathered. The odds ratio (OR) was used as a summary statistic. A random‐effects model was used. A fully percutaneous TSc TAVI case from our institution illustrates minimalist approach.
Results
Final analysis was made with six studies including 4,504 patients (3,886 TF and 618 TSc). Baseline characteristics of compared groups in individual studies were similar, with the exception of a higher logistic EuroSCORE in the TSc group (23.7 ± 1.92 vs. 21.17 ± 3.51, P = 0.04) and higher prevalence of coronary and peripheral artery disease with OR = 0.67 95% CI: 0.54–0.83 (P = 0.0003) and OR = 0.08 95% CI: 0.05–0.12 (P < 0.00001), respectively. TSc group presented comparable 30‐day mortality (OR = 1.37; 95%CI: 0.85–2.21; P = 0.20). There were no differences for procedural success, 30‐day stroke rate, need for new pacemaker implantation, major vascular complications, and acute kidney injury requiring dialysis. Also, no differences were found concerning 1‐year mortality.
Conclusions
Our study suggests that TSc approach may be, not only an alternative route to TF approach for TAVI, but even a competitive one in certain patients with increased risk of femoral injury.
Objectives This study sought to evaluate the incidence, predictive factors, and prognostic value of new-onset atrial fibrillation (NOAF) following transcatheter aortic valve implantation (TAVI). ...Background Very few data exist on the occurrence of NOAF following TAVI. Methods A total of 138 consecutive patients with no prior history of atrial fibrillation (AF) underwent TAVI with a balloon-expandable valve. Patients were on continuous electrocardiogram monitoring until hospital discharge, and NOAF was defined as any episode of AF lasting >30 s. All clinical, echocardiographic, procedural, and follow-up data were prospectively collected. Results NOAF occurred in 44 patients (31.9%) at a median time of 48 h (interquartile range: 0 to 72 h) following TAVI. The predictive factors of NOAF were left atrial (LA) size (odds ratio OR: 1.21 for each increase in 1 mm/m2 , 95% confidence interval CI: 1.09 to 1.34, p < 0.0001) and transapical approach (OR: 4.08, 95% CI: 1.35 to 12.31, p = 0.019). At 30-day follow-up, NOAF was associated with a higher rate of stroke/systemic embolism (13.6% vs. 3.2%, p = 0.021, p = 0.047 after adjustment for baseline differences between groups), with no differences in mortality rate between groups (NOAF: 9.1%, no-NOAF: 6.4%, p = 0.57). At a median follow-up of 12 months (interquartile range: 5 to 20 months), a total of 27 patients (19.6%) had died, with no differences between the NOAF (15.9%) and no-NOAF (21.3%) groups, p = 0.58. The cumulative rate of stroke and stroke/systemic embolism at follow-up were 13.6% and 15.9%, respectively, in the NOAF group versus 3.2% in the no-NOAF group (p = 0.039, adjusted p = 0.037 for stroke; p = 0.020, adjusted p = 0.023 for stroke/systemic embolism). Conclusions NOAF occurred in about one-third of the patients with no prior history of AF undergoing TAVI and its incidence was increased in patients with larger LA size and those undergoing transapical TAVI. NOAF was associated with a higher rate of stroke/systemic embolism, but not a higher mortality, at 30 days and at 1-year follow-up.
Objectives
We aimed to describe hemodynamic performance and clinical outcomes at 30‐day follow‐up of the balloon‐expandable (BE) Myval transcatheter heart valve (THV) in low‐risk patients.
Background
...The results of the next‐generation BE Myval THV in low‐risk aortic stenosis (AS) patients are still unknown.
Methods
Retrospective registry performed in nine European centers including patients with low predicted operative mortality risk according to Society of thoracic surgeons (STS) and European system for cardiac operative risk evaluation (EuroSCORE‐II) scores.
Results
Between September 2019 and February 2021, a total of 100 patients (51% males, mean age 80 ± 6.5 years) were included. Mean STS score and EuroSCORE‐II were 2.4 ± 0.8% and 2.2 ± 0.7%, respectively. Intermediate sizes were used in 39% (21.5 mm: 8%, 24.5 mm: 15%, 27.5 mm: 15%). There were no cases of valve embolization, coronary artery occlusion, annulus rupture, or procedural death. A definitive pacemaker implantation was needed in eight patients (8%). At 30‐day follow‐up aortic valve area (0.7 ± 0.2 vs. 2.1 ± 0.6 cm2) and mean aortic valve gradient (43.4 ± 11.1 vs. 9.0 ± 3.7 mmHg) improved significantly (p < 0.001). Moderate aortic regurgitation occurred in 4%. Endpoints of early safety and clinical efficacy were 3 and 1%, respectively.
Conclusions
Hemodynamic performance and 30‐day clinical outcomes of the BE Myval THV in low‐risk AS patients were favorable. Longer‐term follow‐up is warranted.
Valve‐in‐valve (ViV) transcatheter procedures have emerged as a feasible, less‐invasive treatment option for bioprosthetic structural valve deterioration. However, in the presence of a small ...bioprosthesis, a significant residual gradient after ViV procedures often occurs and has been associated with poorer clinical outcomes. We report the use of the self‐expandable supra‐annular ACURATE neo™ valve to treat degenerated Mitroflow (Sorin) aortic bioprosthesis with severe residual elevated gradients followed by valve fracture with a postdilation using a noncompliant balloon leading to significant reduction in residual gradients. In conclusion, the use of ACURATE neo™ valve followed by the controlled fracture of the surgical bioprosthesis frame with a noncompliant balloon is a safe and effective approach for patients with Mitroflow® failing valves and residual elevated gradient after transcatheter aortic valve replacement.
Background
Transcatheter aortic valve replacement (TAVR) via transaxillary (TAx) approach with ACURATE neo valve is an off‐label procedure. Our aim was to gather information on ACURATE neo cases ...implanted via TAx approach and report major outcomes.
Methods and Results
The TRANSAX Study (NCT04274751) retrospectively gathered patients from nine centres in Europe and North America treated with ACURATE neo valve through TAx approach up to May/2019. Follow up was pre‐specified at 1‐year and was obtained for all patients.
A total of 75 patients (79 ± 10 years; 32% women) were included. Left axillary (72%) and conscious sedation (95.2%) were the most common setting. Risk scores were higher when right axillary artery and surgical cut‐down were selected. Severe complications including valve embolization, coronary obstruction, annulus rupture, and procedural mortality did not occur. Cardiac tamponade occurred in two cases (2.7%) with one requiring conversion to open surgery (1.3%). Bail‐out stenting and surgical vascular repair were required in 7 (9.3%) and 3 (4%) cases, respectively. The need for new permanent pacemaker was 8%. Procedural success (96%), in‐hospital (2.7%), and 1‐year mortality (8%) were comparable in all settings. Only one case (1.3%) complicated with cerebrovascular event and one (1.3%) presented moderate aortic regurgitation before discharge.
Conclusions
TAx TAVR procedures with the ACURATE neo valve were presented high success rate and low in‐hospital and 1‐year mortality.
Highlights
The TRANSAX Study (NCT04274751) retrospectively gathered 75 patients (79 ± 10 years; 32% women) from nine centres in Europe and North America treated with ACURATE neo valve through off‐label transaxillary approach. Most patients were treated through left axillary artery (72%) and under conscious sedation (95.2%). Severe complications as valve embolization, coronary obstruction, annulus rupture, and procedural mortality did not occur. Bail‐out stenting and surgical vascular repair were required in 7 (9.3%) and 3 (4%) cases, respectively. The procedure was feasible and safe with low rate of complications and mortality.
Aims
In heart failure (HF), implantable haemodynamic monitoring devices have been shown to optimize therapy, anticipating clinical decompensation and preventing hospitalization. Direct left‐sided ...haemodynamic sensors offer theoretical benefits beyond pulmonary artery pressure monitoring systems. We evaluated the safety, usability, and performance of a novel left atrial pressure (LAP) monitoring system in HF patients.
Methods and results
The VECTOR‐HF study (NCT03775161) was a first‐in‐human, prospective, multicentre, single‐arm, clinical trial enrolling 30 patients with HF. The device consisted of an interatrial positioned leadless sensor, able to transmit LAP data wirelessly. After 3 months, a right heart catheterization was performed to correlate mean pulmonary capillary wedge pressure (PCWP) with simultaneous mean LAP obtained from the device. Remote LAP measurements were then used to guide patient management. The miniaturized device was successfully implanted in all 30 patients, without acute major adverse cardiac and neurological events (MACNE). At 3 months, freedom from short‐term MACNE was 97%. Agreement between sensor‐calculated LAP and PCWP was consistent, with a mean difference of −0.22 ± 4.92 mmHg, the correlation coefficient and the Lin's concordance correlation coefficient values were equal to 0.79 (p < 0.0001) and 0.776 (95% confidence interval 0.582–0.886), respectively. Preliminary experience with V‐LAP‐based HF management was associated with significant improvements in New York Heart Association (NYHA) functional class (32% of patients reached NYHA class II at 6 months, p < 0.005; 60% of patients at 12 months, p < 0.005) and 6‐min walk test distance (from 244.59 ± 119.59 m at baseline to 311.78 ± 129.88 m after 6 months, p < 0.05, and 343.95 ± 146.15 m after 12 months, p < 0.05).
Conclusion
The V‐LAP™ monitoring system proved to be generally safe and provided a good correlation with invasive PCWP. Initial evidence also suggests possible improvement in HF clinical symptoms.
VECTOR‐HF trial highlights. 6MWT, 6‐min walk test; FUP, follow‐up; HF, heart failure; LAP, left atrial pressure; LVEF, left ventricular ejection fraction; M, months; MACNE, major adverse cardiac and neurological event; (NT‐pro‐)BNP, (N‐terminal pro‐)B‐type natriuretic peptide; NYHA, New York Heart Association; PCWP, pulmonary capillary wedge pressure; RHC, right heart catheterization.
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