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Background: With the introduction of transcatheter aortic valve implantation, the role of surgical aortic valve replacement (SAVR) in elderly patients has been called into question. We investigated the short-term outcomes of SAVR in the elderly population. Methods: All patients aged ≥ 70 years who underwent isolated SAVR in our centre between 2008 and 2017 were included in the study. Survival at 30 days and 1 year were compared for patients aged 70–79 years (n = 809) versus patients aged ≥ 80 years (n = 322). Factors associated with poorer survival outcomes were identified using multivariable Cox regression analysis. Results: Patients aged 70–79 years and patients aged ≥ 80 years had similar survival rates at 30 days (98.1% vs. 98.4%, p = 0.732) and 1 year (96.0% vs. 94.1%, p = 0.162) post-SAVR. This remained true after multivariable adjustment. Risk factors for 30 day all-cause mortality included insulin dependent diabetes (HR 6.17, 95% CI 1.32–28.92, p = 0.021) and increasing cardiopulmonary bypass time (HR 2.72, 95% CI 1.89–3.91, p < 0.0001). Significant risk factors for 1 year all-cause mortality were New York Heart Association (NYHA) class IV (HR 6.25, 95% CI 1.55–25.24, p = 0.010) and longer cardiopulmonary bypass time (HR 1.94, 95% CI 1.40–2.69, p < 0.0001). Similar results were obtained for cardiac-specific mortality. Conclusions: Short-term outcomes of SAVR are excellent in elderly patients and age alone is not a predictor of poorer outcomes. However, the increased risk of mortality in patients with insulin-dependent diabetes and those with severe functional impairment (NYHA class IV) should be carefully considered when selecting patients for SAVR in this elderly population. [ABSTRACT FROM AUTHOR]

Background: To compare functional and health related quality of life outcomes post-transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in patients with critical aortic stenosis (AS) across low to high-risk surgical candidates. These patient-centred factors will be compared between both groups in the short to medium term time frames and will aid in shared decision making between patients and healthcare workers. Materials and methods: We conducted a systematic review and meta-analysis of randomised controlled trials which compared TAVI with SAVR and reported on quality of life (QoL) and functional scores. The scores used were the Kansas City Cardiomyopathy Questionnaire (KCCQ), Euroqol-5DL (EQ5DL), the short form-36/12 (SF-36/12) and the NYHA. Results: We identified eight trials with a total of 8898 participants. Both groups showed improvements from baseline at one month. At one month there was a statistically significant difference in standardised mean difference (SMD) in favour of TAVI for EQ5DL (SMD 0.37, 95% CI 0.26,0.49), KCCQ (SMD 0.53,95% CI 0.48, 0.58), SF physical summary (SMD 0.55, 95% CI 0.31 – 0.78) and SF mental summary (SMD 0.34, 95% CI 0.27 – 0.40). At one year there was no statistically significant difference between any of these QoL metrics. For NYHA, no significant difference in odds ratio of class III/IV was observed at one month between TAVI and SAVR (OR 0.94, 95% CI 0.83, 1.07), however, TAVI was associated with reduced odds ratio of NYHA class I/II at one year (OR 0.87, 95% CI 0.78, 0.98). Conclusion: Both groups were associated with improvements in QoL and functional outcomes with TAVI reporting more significant improvements in QoL at one-month post-procedures. No significant improvements between groups were seen at one year. This is the largest meta-analysis comparing post-operative health-related quality of life outcomes post SAVR and TAVI and has major implications in shared decision making for the treatment of aortic stenosis. Key points: Aim: To compare functional and health related quality of life outcomes across all surgical risk groups post-transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in patients with critical aortic stenosis (AS). Findings: Both groups were associated with improvements in QoL and functional outcomes with TAVI reporting more significant improvements in QoL at one-month post-procedures. No significant improvements between groups were seen at one year. Message: Greater short-term improvements in quality of life/functional outcome measures seen in the TAVI group are likely due to its less invasive nature and this should be taken into consideration in patient-centred decision-making. [ABSTRACT FROM AUTHOR]

Background: Transcatheter aortic valve replacement (TAVR) is increasingly used to treat patients with severe aortic stenosis (AS). Cardiovascular magnetic resonance imaging (CMR) provides reliable and reproducible estimates for assessment of cardiac structure and function after TAVR. The goal of this study was to conduct a systematic review and meta-analysis of the literature to assess left ventricular (LV) volumes, mass and function by CMR after TAVR. Methods: Using Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines, we searched PubMed and Embase for studies reporting CMR findings before and at least 1 month after TAVR. Main factors of interest were LV end-diastolic volume index (LVEDVi), LV end-systolic volume index (LVESVi), LV mass index (LVMi), and left ventricular ejection fraction (LVEF). Standardized mean differences (SMD) were pooled by random effects meta-analytic techniques. Results: Of 453 screened publications, 10 studies (published between 2012 and 2018) were included. A total of 305 patients completed pre- and post-TAVR follow-up CMR (mean age range 78.6–85.0 years, follow-up range 6–15 months). Random effects analysis showed TAVR resulted in reduced LVEDVi (SMD: -0.25, 95% CI: − 0.43 to − 0.07, P = 0.006), LVESVi (SMD: -0.24, 95% CI: − 0.44 to − 0.05, P = 0.01), LVMi (SMD: -0.82, 95% CI: − 1.0 to − 0.63, P < 0.001) and increased LVEF (SMD: 22, 95% CI: 6 to 38%, P = 0.006). Heterogeneity across studies was low (I2: 0%, Pheterogeneity > 0.05 for all). The median reduction was 4 ml/m2 (IQR: 3.1 to 8.2) for LVEDVi, 5 ml/m2 (IQR: 3.0 to 6.0) for LVESVi, and 15.1 g/m2 (IQR: 11.8 to 18.3) for LVMi. The median increase for LVEF was 3.4% (IQR 1.0 to 4.6%). Conclusions: CMR demonstrates reverse LV remodeling occurrs within 6–15 months after TAVR, with reductions in LVEDVi, LVESVi and LVMi, and increased LVEF. [ABSTRACT FROM AUTHOR]

Background: In older patients with aortic stenosis (AS) undergoing TAVI, the potential role of prior CGA is not well established. To explore the value of comprehensive geriatric assessment (CGA) for predicting mortality and/or hospitalisation within the first 3 months after transcatheter aortic valve implantation (TAVI).Methods: An international, multi-centre, prospective registry (CGA-TAVI) was established to gather data on CGA results and medium-term outcomes in geriatric patients undergoing TAVI. Logistic regression was used to evaluate the predictive value of a multidimensional prognostic index (MPI); a short physical performance battery (SPPB); and the Silver Code, which was based on administrative data, for predicting death and/or hospitalisation in the first 3 months after TAVI (primary endpoint).Results: A total of 71 TAVI patients (mean age 85.4 years; mean log EuroSCORE I 22.5%) were enrolled. Device success according to VARC criteria was 100%. After adjustment for selected baseline characteristics, a higher (poorer) MPI score (OR: 3.34; 95% CI: 1.39-8.02; p = 0.0068) and a lower (poorer) SPPB score (OR: 1.15; 95% CI: 1.01-1.54; p = 0.0380) were found to be associated with an increased likelihood of the primary endpoint. The Silver Code did not show any predictive ability in this population.Conclusions: Several aspects of the CGA have shown promise for being of use to physicians when predicting TAVI outcomes. While the MPI may be useful in clinical practice, the SPPB may be of particular value, being simple and quick to perform. Validation of these findings in a larger sample is warranted.Trial Registration: The trial was registered in ClinicalTrials.gov on November 7, 2013 ( NCT01991444 ). [ABSTRACT FROM AUTHOR]

Background: Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence has suggested that aortic valvuloplasty may cause complications and that high success rates may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation of the aortic valve and using new-generation balloon-expandable transcatheter heart valves is associated with a better net clinical benefit than TAVI performed with predilatation.Methods/design: The transcatheter aortic valve implantation without prior balloon dilatation (DIRECTAVI) trial is a randomized controlled open label trial that includes 240 patients randomized to TAVI performed with prior balloon valvuloplasty (control arm) or direct implantation of the valve (test arm). All patients with an indication for TAVI will be included excepting those requiring transapical access. The trial tests the hypothesis that the strategy of direct implantation of the new-generation balloon-expandable SAPIEN 3 valve is noninferior to current medical practice using predilatation of the valve. The primary endpoint assessing efficacy and safety of the procedure consists of immediate procedural success and secondary endpoints include complications at 30-day follow-up (VARC-2 criteria). A subgroup analysis evaluates neurological ischemic events with cerebral MRI imaging (25 patients in each strategy group) performed before and between 1 and 3 days after the procedure.Discussion: This prospective randomized study is designed to assess the efficacy and safety of TAVI performed without prior dilatation of the aortic valve using new-generation balloon-expandable transcatheter heart valves. We aim to provide robust evidence of the advantages of this strategy to allow the interventional cardiologist to use it in everyday practice.Trial Registration: ClinicalTrials.gov identifier: NCT02729519 . Registered on 15 July 2016. [ABSTRACT FROM AUTHOR]

Background: Previous studies have suggested that concomitant mitral regurgitation (MR) is a risk factor for acute transcatheter aortic valve implantation (TAVI) failure, but may improve afterwards. Aim of this study was to assess the prevalence, clinical meaning and modifications of MR in patients undergoing TAVI.Methods: In a retrospective, two-center (Potenza-San Carlo and Roma- San Camillo) study, from January 2010 to June 2014 we enrolled 165 consecutive patients (age =80 ± 5 years, 74 males, Ejection Fraction 51 ± 9 %) referred for TAVI with either Medtronic Core-ReValving System (in 114 patients, 69%) or balloon-expandable Edwards SAPIEN/SAPIEN XT (in 51 patients, 31%). All patients underwent TTE and TEE assessment of MR (from 1, mild to 4 = severe according to ESC latest guidelines) with core lab reading by a single observer blinded to patient identity and status. Assessment was performed at baseline (24 h prior to intervention) and at 1, 6, 12 and 24 months.Results: Mild-to-Moderate MR (grade 1-2) was present in 137 patients and Moderate-to-Severe MR (grade 3-4) was present in 28 patients. No significant differences were seen comparing perioperative mortality and morbidity between the two groups. In the group of preoperative MR grade 3-4 the mean decrease from MR pre-TAVI to MR at 1 month post-TAVI was 0.464 (p < 0.0001) and this improvement was persistent at 6 months (p < 0.0001) and at 12 months (p < 0.0001), with partial benefit loss at 1 and 2 years. The mean difference from Left Atrial volume post-TAVI at 1 month was 16.5 ml (p < 0.0001) and this improvement was persistent at 12 months 12.12 ml (p < 0.0001).Conclusions: TAVI effectively treats the aortic valve but as a beneficial by product also ameliorates concomitant MR. The presence of moderate-to-severe MR does not increase the acute risk of failure of TAVI. In successful procedures, the MR improves immediately and persistently. [ABSTRACT FROM AUTHOR]

Background: Aortic stenosis is a prevalent heart valvular disorder in Iran. Transcatheter Aortic Valve Implantation (TAVI) and Surgical Aortic Valve Replacement (SAVR) are two common procedures for treating the disease in the current clinical pathway. However, TAVI is an expensive procedure, and for Iran with severe limitations in financial resources, it is crucial to investigate the cost-effectiveness of the technology against other competing alternatives with the same purpose. This study aims to analyse the cost-effectiveness of TAVI vs SAVR in elderly patients who are at a higher risk of surgery., Methods: This study is a decision economic evaluation modeling, with a lifetime horizon and a healthcare payer (health insurer) perspective. The utility values are from a previous study, transitional probabilities come from an established clinical trial called PARTNER-1, and the unit costs are from Iran's national fee schedule for medical services. The probabilistic and one-way sensitivity analyses have been performed to mitigate the uncertainty., Results: The incremental cost, effectiveness, and cost-effectiveness ratio for the base case were: 368,180,101 Iranian Rial, (US$ 1,473), 0.37 QALY-per-patient, and, 995,081,354 Iranian Rial (US$ 3,980), respectively. The probabilistic sensitivity analysis yielded 981,765,302 I.R.I Rials (US$ 3,927) per patient for the ICER. The probability of being cost-effective at one and three times the country's Gross Domestic Production (GDP) is 0.31 and 0.83, respectively., Conclusions: TAVI does not seem a cost-effective procedure in comparison with SAVR at the current willingness to pay thresholds of the country. However, by increasing the WTP threshold to 3 times the GDP per capita the probability of being cost-effective will raise to 83%., (© 2022. The Author(s).)

Increased life expectancy has led to the presentation of more complicated patients in old age for the replacement of the aortic valve. The emergence of Transcatheter Aortic Valve Implantation (TAVI) was considered as a significant breakthrough in the management of symptomatic, moribund patients suffering from aortic valve stenosis who had been rejected for surgical intervention. A novel technology often has a long journey from the point at which it is created to its every-day-use. It is now obvious that TAVI practice in multiple institutes around the world has gone beyond the evidence. Serious concerns have been raised questioning the current TAVI practice. Analysis of future TAVI use may assist clinicians and healthcare managers to understand and deploy this technology in accordance with the evidence. [ABSTRACT FROM AUTHOR]