Citations

Abstract Aims Transcatheter mitral valve replacement (TMVR) with the Tendyne Mitral Valve System is a treatment option for patients with severe symptomatic mitral regurgitation (MR) unsuitable for conventional mitral valve surgery or transcatheter edge-to-edge repair (TEER). This study sought to evaluate the safety and effectiveness of TMVR through 5-year follow-up. Methods and Results The Tendyne Expanded Clinical Study is a prospective, single-arm, multicentre study that enrolled patients between November 2014 and June 2020. The study enrolled 191 patients (mean age 74.1 ± 8.0 years, 62.8% male, 70.2% New York Heart Association Class (NYHA) class III/IV, 88.5% secondary MR), of whom 186 (97.4%) underwent TMVR with Tendyne. MR grade decreased from ≥3+ in 99.5% patients at baseline to grade ≤1+ in 95.3% at 5 years. In those patients surviving to 5 years (n = 49), durable symptomatic improvement was evidenced by 73.5% patients being in NYHA class I/II at 5 years. The Kansas City Cardiomyopathy Questionnaire overall summary score increased from 48.5 ± 22.5 points at baseline to 67.6 ± 21.5 points at 5 years. Serious adverse events that occurred through 5 years included life-threatening bleeding (11.5%), fatal bleeding (2.6%), renal insufficiency/failure (28.8%), endocarditis (7.3%), device thrombosis (5.8%), and new onset atrial fibrillation (13.1%). No structural device degeneration or device embolism occurred through 5 years. Conclusions The Tendyne TMVR was effective at achieving immediate and sustainable elimination of MR, which was associated with symptomatic improvement and absence of structural valve degeneration in a high-risk cohort over 5 years. These findings support TMVR with the Tendyne System as an alternative for patients with appropriate mitral valve anatomy and symptomatic secondary MR unsuitable for mitral surgery or TEER.

Abstract Objectives In an effort to maintain the technical aspects of traditional prosthetic surgical aortic valve replacement (AVR) while reducing invasiveness and facilitate options for concomitant operations, transaxillary lateral mini-thoracotomy endoscopic robotic-assisted aortic valve replacement (RAVR) has been introduced. The present data highlight the contemporary international collaborative experience. METHODS All consecutive patients undergoing standardized RAVR across 10 international sites (1/2020–7/2024) were evaluated using a central database with 1 year follow-up. RESULTS A total of 300 patients were analysed with a median predicted risk of 1.6% with aortic stenosis in 85.7%, nearly half with bicuspid valves. Biological prostheses were implanted in 220 (73.3%) with a median valve size 23 mm, 10% receiving aortic root enlargement, with 17% of all patients undergoing concomitant procedures. Median cross-clamp 120 min with no conversions to sternotomy. Median length of stay was 5 days, 4.3% with prolonged ventilation, 1.7% renal failure, 1.0% stroke and 8.3% required re-thoracotomy for evacuation of haemothorax. There were two 30-day operative mortalities (0.7%). The new permanent pacemaker rate for the full cohort was 2.6%. Of 163 patients with complete 1-year clinical and echocardiographic follow-up, mean aortic valve gradient was 10 mmHg and all but 2 patients (1.2%) had trace to no prosthetic or paravalvular insufficiency. CONCLUSIONS RAVR is safe and effective, providing the reproducible benefits of surgical AVR while affording a less invasive approach that permits the opportunity for concomitant procedures. For low and intermediate risk patients with aortic valve disease, RAVR is a potential reproducible alternative for patients and heart teams.

Background: Robust models exist to predict risk-adjusted mortality following congenital heart surgery. It is known that underlying diagnosis modifies predicted risk of operations, and institution-level outcomes vary based on their unique case mix. We therefore evaluated risk-adjusted outcomes for a subset of diagnosis-procedure (D-P) combinations within the Society of Thoracic Surgeons' (STS) congenital heart surgery database (CHSD). Methods: A clinician panel identified the most frequently encountered D-P combinations in CHSD between 07/2017 and 06/2021. Candidate modeling techniques were compared in a random 80% development cohort. Model performance was assessed using internal and cross-validation calibration, discrimination plots and optimism adjusted C-statistics. The final selected model was evaluated in the 20% validation sample. Results: The chosen subset of D-P combinations represented 45,384 of 87,589 (52%) unique episodes of surgical care in CHSD during this time-period. The development cohort (36,350 episodes) had 1.8% mortality (667 deaths). All candidate models had excellent discrimination with C-statistics ranging from 0.862 to 0.876. The model with the best combination of discrimination, calibration, and clinical face validity was a modified version of the current STS mortality risk model. This version included all current risk model variables with the addition of indicator variables for D-P combinations. In the 20% validation sample (9,034 episodes), this model was well calibrated (Figure) and had excellent discrimination (C = 0.879). Conclusion: We describe a cohort of D-P combinations widely encountered in the STS CHSD. Further, we refined the existing STS CHSD risk model for application to these D-P dyads to derive empirical risk-adjusted benchmark outcomes. This approach will benefit quality improvement efforts at an institutional level and may have implications for publicly reporting congenital heart surgery outcomes.

Background Data on national trends in mortality due to infective endocarditis (IE) in the United States are limited. Methods and Results Utilizing the multiple causes of death data from the Centers for Disease Control and Prevention's Wide‐Ranging Online Data for Epidemiologic Research database from 1999 to 2020, IE and substance use were identified using the International Classification of Diseases, Tenth Revision, Clinical Modification codes. Between 1999 and 2020, the IE‐related age‐adjusted mortality rates declined. IE‐related crude mortality accelerated significantly in the age groups 25–34 years (average annual percentage change, 5.4 [95% CI, 3.1–7.7]; P <0.001) and 35–44 years (average annual percentage change, 2.3 [95% CI, 1.3–3.3]; P <0.001), but remained stagnant in those aged 45–54 years (average annual percentage change, 0.5 [95% CI, −1.9 to 3]; P =0.684), and showed a significant decline in those aged ≥55 years. A concomitant substance use disorder as multiple causes of death in those with IE increased drastically in the 25–44 years age group ( P <0.001). The states of Kentucky, Tennessee, and West Virginia showed an acceleration in age‐adjusted mortality rates in contrast to other states, where there was predominantly a decline or static trend for IE. Conclusions Age‐adjusted mortality rates due to IE in the overall population have declined. The marked acceleration in mortality in the 25‐ to 44‐year age group is a cause for alarm. Regional differences with acceleration in IE mortality rates were noted in Kentucky, Tennessee, and West Virginia. We speculate that this acceleration was likely due mainly to the opioid crisis that has engulfed several states and involved principally younger adults.

Background Studies assessing the differential impact of sex on outcomes of aortic valve replacement ( AVR ) yielded conflicting results. We sought to investigate sex‐related differences in AVR utilization, patient risk profile, and in‐hospital outcomes using the Nationwide Inpatient Sample. Methods and Results In total, 166 809 patients (63% male and 37% female) who underwent AVR between 2003 and 2014 were identified, and 48.5% had a concomitant cardiac surgery procedure. Compared with men, women were older and had more nonatherosclerotic comorbid conditions including hypertension, diabetes mellitus, obstructive pulmonary disease, atrial fibrillation/flutter, and anemia but fewer incidences of coronary and peripheral arterial disease and prior sternotomies. In‐hospital mortality was significantly higher in women (5.6% versus 4%, P <0.001). Propensity matching was performed to assess the impact of sex on the outcomes of isolated AVR and yielded 28 237 matched pairs of male and female participants. In the propensity‐matched groups, in‐hospital mortality was higher in women (3.3% versus 2.9%, P <0.001). Along with vascular complications and blood transfusion (6% versus 5.6%, P =0.027 and 40.4% versus 33.9%, P <0.001, respectively). Rates of stroke, permanent pacemaker implantation, and acute kidney injury requiring dialysis were similar (2.4% versus 2.4%, P =0.99; 6% versus 6.3%, P =0.15; and 1.4% versus 1.3%, P =0.14, respectively). Length of stay median and interquartile range were both similar between groups (7±6 days). Rates of nonhome discharge were higher among women (27.9% versus 19.6%, P <0.001). Conclusions Women have worse in‐hospital mortality following AVR compared with men. Coupled with the accumulating evidence suggesting higher magnitude of benefit of transcatheter AVR over AVR in women, women should perhaps be offered transcatheter AVR over AVR at a lower threshold than men.