Abstract Background Three in ten severe aortic stenosis patients undergoing transcatheter aortic valve implantation (TAVI) are frail. Frailty correlates with adverse post-procedure patient outcomes, such as higher 1-year mortality, increased adverse events, prolonged hospital stays, and diminished quality of life. Despite the urgency for evidence-based frailty management in this population, research in this area is limited. Methods A pilot, cluster randomised controlled trial to assess the feasibility of implementing a Frailty Response Program intervention in 10 hospital TAVI programs for frail patients with aortic stenosis undergoing valve replacement. The intervention includes an implementation strategy and a Frailty Response Clinical Protocol, focused on malnutrition identification, patient education, general practitioner notification, comprehensive geriatric assessment, and cardiac rehabilitation. Eligible hospitals will be randomised (1:1) to either the intervention or control (standard care). Primary outcome: proportion of patients receiving nutritional assessment upon frailty identification. Secondary outcomes include mortality and hospital admissions, frailty improvement, quality of life, and evidence-based frailty management. Implementation outcomes will be evaluated through a process assessment. Discussion The trial aims to bridge the gap between the recognition of frailty in patients with aortic stenosis undergoing TAVI and the implementation of evidence-based frailty management practices to improve patient outcomes and care quality.
Background— Transcatheter aortic valve-in-valve implantation is an emerging therapeutic alternative for patients with a failed surgical bioprosthesis and may obviate the need for reoperation. We evaluated the clinical results of this technique using a large, worldwide registry. Methods and Results— The Global Valve-in-Valve Registry included 202 patients with degenerated bioprosthetic valves (aged 77.7±10.4 years; 52.5% men) from 38 cardiac centers. Bioprosthesis mode of failure was stenosis (n=85; 42%), regurgitation (n=68; 34%), or combined stenosis and regurgitation (n=49; 24%). Implanted devices included CoreValve (n=124) and Edwards SAPIEN (n=78). Procedural success was achieved in 93.1% of cases. Adverse procedural outcomes included initial device malposition in 15.3% of cases and ostial coronary obstruction in 3.5%. After the procedure, valve maximum/mean gradients were 28.4±14.1/15.9±8.6 mm Hg, and 95% of patients had ≤+1 degree of aortic regurgitation. At 30-day follow-up, all-cause mortality was 8.4%, and 84.1% of patients were at New York Heart Association functional class I/II. One-year follow-up was obtained in 87 patients, with 85.8% survival of treated patients. Conclusions— The valve-in-valve procedure is clinically effective in the vast majority of patients with degenerated bioprosthetic valves. Safety and efficacy concerns include device malposition, ostial coronary obstruction, and high gradients after the procedure.
The impact of transcatheter aortic valve implantation (TAVI) on left ventricular (LV) mass regression is not well defined. We aimed to measure LV mass regression, changes in LV volumes and dimensions, as well as mitral valve function after TAVI.Eighty patients who underwent TAVI between 2008 and 2010 were studied. Echocardiographic findings before procedure and at 6- and 12-month follow-up were analyzed.Aortic valve area increased from 0.71 (0.27) cm before procedure to 1.89 (0.64) cm at 12 months (P < 0.001), which was associated with reduction in peak [80.79 (23) vs 16.9 (6.5) mm Hg, P < 0.001] and mean [47.65 (14.2) vs 8.77 (3.29) mm Hg, P < 0.001] gradients. At 1 year, there was a change in LV end-systolic volume [46.12 (36.6) to 48.96 (4.05) mL, P = 0.042] and LV mass [202.4 (92.2) to 183.6 (98.2) g, P = 0.04]. Left ventricular mass index regressed from 130.7 (28.9) to 122.1 (28.9) g/m (P = 0.01). Maximum wall thickness decreased from 1.28 (0.18) to 1.25 (0.17) cm (P < 0.001). There was no significant change in LV ejection fraction, LV end-systolic and end-diastolic diameters, as well as mitral valve regurgitation.Transcatheter aortic valve implantation is associated with significant regression of LV hypertrophy at 1 year. However, this regression was not associated with changes in LV systolic and diastolic functions, size, or changes in mitral valve regurgitation.
The first implantation of a Starr-Edwards valve prosthesis was in 1960.1 This valve was extremely successful and many thousands of patients benefited from it. It has been superseded by new valve designs.
A 75-year-old woman with a Starr-Edwards valve in the mitral position inserted in 1996 for mitral stenosis developed symptomatic severe aortic stenosis in 2011. She was considered not suitable for surgical aortic valve replacement due to general frailty and the high risks of a repeat sternotomy and the decision was …
e17104 Background: Understanding the prognostic impact of BRCA mutation status across prostate cancer (PCa) patient segments is critical to deploying the right therapies at the right time in a patient’s journey. Prior studies have shown that germline BRCA mutations are associated with poorer outcomes in an all-risk localized PCa population. To examine whether this association extends to a high-risk PCa population with either somatic or germline BRCA mutations, we evaluate the prevalence and independent prognostic impact of BRCA mutations in a real-world (RW), high-risk, localized/locoregional PCa population. Methods: A retrospective study (2016-2023) was performed using a de-identified multimodal RW dataset of patients undergoing Tempus xT next-generation sequencing. Eligible patients had localized/locoregional PCa at primary diagnosis (pDx), were biopsied prior to metastatic diagnosis, received adjuvant radiotherapy and/or had a prostatectomy, and had an evaluable Gleason score (GS). Risk groups were categorized as low/intermediate (low/int)-risk (total GS <8) and high-risk (total GS ≥8). BRCA status was defined as BRCAm if the patient had a short variant that was predicted or known to be pathogenic or a copy number loss in BRCA1 or BRCA2 and BRCAwt if no mutation was detected. Median real-world metastasis-free survival (rwMFS), defined as time from primary intervention to first metastatic diagnosis, was estimated using Kaplan-Meier methods and stratified by combined BRCA status and risk group (BRCAm high-risk, BRCAm low/int-risk, BRCAwt high-risk, BRCAwt low/int-risk). To assess the independent prognostic value of BRCA status among all patients and within a high-risk subset, two multivariate Cox models were performed adjusting for risk group, age at pDx, baseline PSA, primary intervention type, and T and N stage at pDx. Results: Among 607 eligible patients, 67 (11%) had a BRCA mutation (11 germline, 27 somatic, 29 tumor/unknown). Median rwMFS was longest in the BRCAwt low/int-risk group (n=147) at 50 mos (95% CI: 41, NA), followed by the BRCAwt high-risk group (n=393) at 36 mos (95% CI: 31, 42), and the BRCAm high-risk group (n=61) at 22 mos (95% CI: 11, 45). Median rwMFS estimates in the BRCAm low/int-risk group were unreliable due to a small sample size (n=6). From the adjusted Cox model, BRCAm patients had higher risk of metastasis compared to BRCAwt patients in the all-risk group (HR=1.48, 95% CI: 1.06, 2.09) and in the high-risk subset (HR=1.50, 95% CI: 1.04, 2.17). Conclusions: Our findings show that BRCAm is independently prognostic of metastasis in a RW, localized/locoregional, high-risk PCa population. We identify high-risk BRCAm patients as a subgroup with significantly elevated risk of developing metastasis; clinical trials with targeted therapeutic intervention may be needed to address the clinical unmet need.
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