Natural History of Mitral Regurgitation After Transcatheter Aortic Valve Implantation.

BACKGROUND: This study sought to determine the impact of mitral regurgitation (MR) on outcomes after transcatheter aortic valve implantation (TAVI). METHODS: This was an observational study of TAVI for aortic stenosis (AS) from November 2012 to December 2021; 25% of patients were excluded because post-TAVI echocardiograms were unavailable. Excluded patients had a higher Society of Thoracic Surgeons predicted risk of mortality score than included patients (5.6% vs 4.9%). Patients were dichotomized according to the severity of pre-TAVI MR: < moderate vs ≥ moderate. RESULTS: A total of 2250 patients underwent TAVI, of whom 329 (14.6%) had MR ≥ moderate before TAVI. Baseline MR ≥ moderate was associated with reduced survival (46.2% for MR ≥ moderate vs 58.7% for MR < moderate; P < .001) and a higher incidence of heart failure readmission at 5 years after TAVI; 11% of patients had progression or persistence of MR ≥ moderate at 1 year after TAVI, which was also associated with reduced survival. On multivariable logistic regression, increasing age, women, lower ejection fraction, prior acute coronary syndrome, concomitant aortic insufficiency ≥ moderate, low-flow low-gradient AS, pulmonary hypertension, baseline tricuspid regurgitation ≥ moderate, and lower mean pre-TAVI aortic transvalvular pressure gradient were associated with progression or persistence of MR ≥ moderate at 1 year after TAVI, whereas procedural variables and postprocedural complications were not. CONCLUSIONS: Significant MR before and after TAVI was associated with reduced survival. Whereas various clinical variables were associated with significant MR after TAVI, periprocedural variables were not. Evolution of MR must be carefully surveilled after TAVI, and more data are needed to establish guidelines for managing mixed AS and MR.

Characterization of adverse events in injured patients at risk of hemorrhagic shock: a secondary analysis of three harmonized prehospital randomized clinical trials.

Background: The reporting of adverse events (AEs) is required and well defined in the execution of clinical trials, but is poorly characterized particularly in prehospital trials focusing on traumatic injury. In the setting of prehospital traumatic injury trials, no literature currently exists analyzing the clinical implications of AEs and their associations with mortality and morbidity. We sought to analyze AEs from three prehospital hemorrhagic shock trials and characterize their time course, incidence, severity, associated clinical outcomes, and relatedness. Methods: We performed a secondary analysis of three prehospital randomized clinical trials. We analyzed AEs at both the patient level as well as the individual AE level. We categorized patients who had no AEs, a single documented AE and those with multiple events (>1 AE). We characterized AE timing, severity, relatedness and attributable mortality outcomes. Results: We included 1490 patients from the three harmonized clinical trials, with 299 (20.1%) individual patients having at least a single AE documented with 529 AEs documented overall as a proportion of patients had multiple events. Over 44% of patients had a death-related misclassified AE. Patients with at least a single documented AE had a significantly higher 28-day mortality (log-rank χ2=81.27, p<0.001) compared with those without an AE documented. Patients with a single AE had a significant higher mortality than those with multiple AEs, potentially due to survival bias (log-rank χ2=11.80, p=0.006). When relatedness of each individual AE was characterized, over 97% of AEs were classified as 'definitely not related' or 'probably not related' to the intervention. Conclusions: AEs in hemorrhagic shock trials are common, occur early and are associated with mortality and survival bias. The potential for inaccurate reporting exists, and education and training remain essential for appropriate treatment arm comparison. The current results have important relevance to injury-related clinical trials. Trial registration numbers: NCT01818427, NCT02086500 and NCT03477006. Level of evidence: II.

Long-Term Outcomes of Tricuspid Valve Replacement With Mechanical Versus Tissue Valves: Meta-Analysis of Reconstructed Time-to-Event Data.

Tricuspid valve replacement (TVR) with mechanical versus tissue valves remains a controversial subject. To evaluate the long-term effects of types of valves on patient-relevant outcomes, we performed a systematic review with meta-analysis of reconstructed time-to-event data of studies published by March 15, 2024 (according to referred the Reporting Items for Systematic Reviews and Meta-analyses guidelines). A total of 21 studies met our eligibility criteria and included 7,166 patients (mechanical: 2,495 patients, 34.8%). Patients who underwent mechanical TVR had a lower risk of death than those who received a tissue valve (hazard ratio [HR] 0.77, 95% confidence interval [CI] 0.70 to 0.84, p <0.001). Mechanical TVR was associated with lifetime gain, as evidenced by the restricted mean survival time, which was 2.2 years longer in patients who underwent TVR with mechanical valves (12.4 vs 10.2 years, p <0.001). Our landmark analysis for reoperations revealed the following: from the time point 0 to 7 years, we found no difference in the risk of reoperation between mechanical and tissues valves (HR 0.98, 95% CI 0.60 to 1.61, p = 0.946); however, from the time point 7 years onward, we found that mechanical TVR had a lower risk of reoperation in the follow-up (HR 0.24, 95% CI 0.08 to 0.72, p = 0.001). The meta-regression analysis demonstrated a modulating effect of atrial fibrillation on the association between mechanical valves and mortality; the HRs for all-cause death tended to decrease in the presence of populations with a larger proportion of atrial fibrillation (p = 0.018). In conclusion, our results suggest that TVR with mechanical valves, whenever considered clinically reasonable and accepted by patients as an option, can offer a better long-term survival and lower risk of reoperation in the long run.

Phase-specific survival after endovascular versus open surgical repair of descending thoracic aortic aneurysm.

INTRODUCTION: Thoracic endovascular aortic repair (TEVAR) has gained preference over open surgical repair (OSR) as the intervention of choice for patients with descending thoracic aortic aneurysm (DTA). This study aimed to compare the outcomes of patients with DTA undergoing OSR and TEVAR with contemporary findings. EVIDENCE ACQUISITION: A comprehensive search of MEDLINE and EMBASE databases was conducted to identify relevant randomized controlled trials or studies utilizing propensity-score analysis or reporting risk-adjusted outcomes. The search was performed up until March 2023. EVIDENCE SYNTHESIS: Eight studies met the inclusion criteria, including 4 studies using propensity-score matching and four studies reporting risk-adjusted outcomes, comprising 14,873 patients with DTA undergoing OSR (N.=10,882) and TEVAR (N.=3991). Operative mortality was similar between the two interventions (odds ratio 0.92, 95% CI 0.70-1.21, P=0.57, I2=0%). However, overall long-term mortality was significantly higher after TEVAR compared to OSR (Hazard Ratio [HR] 1.30, 95% CI 1.05-1.59, P=0.01, I2=0%). Phase-specific analysis revealed comparable risks of mortality within 1 year and between one and two years after interventions, while the risk of mortality was significantly higher after TEVAR compared to OSR beyond two years (HR 1.77, 95% CI, 1.19-2.63, P=0.01. I2=0%). CONCLUSIONS: This study demonstrated comparable operative mortality between OSR and TEVAR, but higher long-term mortality associated with TEVAR in patients with DTA. The phase-specific analysis highlighted the survival advantage of OSR beyond 2 years. These findings suggest a need for reconsidering OSR indications in the management of DTA.

Missingness matters: a secondary analysis of thromboelastography measurements from a recent prehospital randomized tranexamic acid clinical trial.

Background: Tranexamic acid (TXA) has been hypothesized to mitigate coagulopathy in patients after traumatic injury. Despite previous prehospital clinical trials demonstrating a TXA survival benefit, none have demonstrated correlated changes in thromboelastography (TEG) parameters. We sought to analyze if missing TEG data contributed to this paucity of findings. Methods: We performed a secondary analysis of the Study of Tranexamic Acid During Air Medical and Ground Prehospital Transport Trial. We compared patients that received TEG (YES-TEG) and patients unable to be sampled (NO-TEG) to analyze subgroups in which to investigate TEG differences. TEG parameter differences across TXA intervention arms were assessed within subgroups disproportionately present in the NO-TEG relative to the YES-TEG cohort. Generalized linear models controlling for potential confounders were applied to findings with p<0.10 on univariate analysis. Results: NO-TEG patients had lower prehospital systolic blood pressure (SBP) (100 (78, 140) vs 125 (88, 147), p<0.01), lower prehospital Glascow Coma Score (14 (3, 15) vs 15 (12, 15), p<0.01), greater rates of prehospital intubation (39.4% vs 24.4%, p<0.01) and greater mortality at 30 days (36.4% vs 6.8%, p<0.01). NO-TEG patients had a greater international normalized ratio relative to the YES-TEG subgroup (1.2 (1.1, 1.5) vs 1.1 (1.0, 1.2), p=0.04). Within a severe prehospital shock cohort (SBP<70), TXA was associated with a significant decrease in clot lysis at 30 min on multivariate analysis (ß=-27.6, 95% CI (-51.3 to -3.9), p=0.02). Conclusions: Missing data, due to the logistical challenges of sampling certain severely injured patients, may be associated with a lack of TEG parameter changes on TXA administration in the primary analysis. Previous demonstration of TXA's survival benefit in patients with severe prehospital shock in tandem with the current findings supports the notion that TXA acts at least partially by improving clot integrity. Level of evidence: Level II.

Lung Transplantation Outcomes in Recipients Aged 70 Years or Older and the Impact of Center Volume.

OBJECTIVE: To evaluate trends and outcomes of lung transplants (LTx) in recipients ≥ 70 years. METHODS: We performed a retrospective analysis of the UNOS database identifying all patients undergoing LTx (May 2005-December 2022). Baseline characteristics and postoperative outcomes were compared by age (<70 years, ≥70 years) and center volume. Kaplan-Meier analyses were performed with pairwise comparisons between subgroups. RESULTS: 34,957 patients underwent LTx, of which 3236 (9.3%) were ≥70 years. The rate of LTx in recipients ≥ 70 has increased over time, particularly in low-volume centers (LVCs); consequently, high-volume centers (HVCs) and LVCs perform similar rates of LTx for recipients ≥ 70. Recipients ≥ 70 had higher rates of receiving from donor after circulatory death lungs and of extended donor criteria. Recipients ≥ 70 were more likely to die of cardiovascular diseases or malignancy, while recipients < 70 of chronic primary graft failure. Survival time was shorter for recipients ≥ 70 compared to recipients < 70 old (hazard ratio (HR): 1.36, 95% confidence interval (CI): 1.28-1.44, p < 0.001). HVCs were associated with a survival advantage in recipients < 70 (HR: 0.91, 95% CI: 0.88-0.94, p < 0.001); however, in recipients ≥ 70, survival was similar between HVCs and LVCs (HR: 1.11, 95% CI: 0.99-1.25, p < 0.08). HVCs were more likely to perform a bilateral LTx (BLT) for obstructive lung diseases compared to LVCs, but there was no difference in BLT and single LTx likelihood for restrictive lung diseases. CONCLUSIONS: Careful consideration is needed for recipient ≥ 70 selection, donor assessment, and post-transplant care to improve outcomes. Further research should explore strategies that advance perioperative care in centers with low long-term survival for recipients ≥ 70.

Valve-in-valve transcatheter aortic valve replacement versus isolated redo surgical aortic valve replacement.

OBJECTIVE: To compare outcomes of patients undergoing valve-in-valve transcatheter aortic valve replacement (ViV TAVR) versus redo surgical aortic valve replacement (SAVR). METHODS: This was a retrospective study using institutional databases of transcatheter (2013-2022) and surgical (2011-2022) aortic valve replacements. Patients who underwent ViV TAVR were compared with patients who underwent redo isolated SAVR. Clinical and echocardiographic outcomes were analyzed. Kaplan-Meier survival estimation and Cox regression were performed. Cumulative incidence functions were generated for heart failure readmissions. RESULTS: A total of 4200 TAVRs and 2306 isolated SAVRs were performed. Of these, there were 198 patients who underwent ViV TAVR and 147 patients who underwent redo SAVR. Operative mortality was 2% in each group, but observed to expected operative mortality in the redo SAVR group was higher than in the ViV TAVR group (1.2 vs 0.32). Those who underwent redo SAVR were more likely to require transfusions and reoperation for bleeding, to have new-onset renal failure requiring dialysis, and to require a permanent pacemaker postoperatively than those in the ViV group. Mean gradient was significantly lower in the redo SAVR group than in the ViV group at 30 days and 1 year. Kaplan-Meier survival estimates at 1 year were comparable, and on multivariable Cox regression, ViV TAVR was not significantly associated with an increased hazard of death compared with redo SAVR (hazard ratio, 1.39; 95% CI, 0.65-2.99; P = .40). Competing-risk cumulative incidence estimates for heart-failure readmissions were higher in the ViV cohort. CONCLUSIONS: ViV TAVR and redo SAVR were associated with comparable mortality. Patients who underwent redo SAVR had lower postoperative mean gradients and greater freedom from heart failure readmissions, but they also had more postoperative complications than the VIV group, despite their lower baseline risk profiles.