National Trends and Outcomes of Acute Myocardial Infarction After Transcatheter Aortic Valve Replacement.

BACKGROUND: Prior studies have reported decreased use of an invasive approach for acute myocardial infarction (AMI) in patients undergoing transcatheter aortic valve replacement (TAVR). OBJECTIVES: The aim of this study was to determine whether prior TAVR affects the use of subsequent coronary revascularization and outcomes of AMI in a contemporary national data set. METHODS: Consecutive TAVR patients from 2016 to 2022 were identified from the U.S. Vizient Clinical Data Base who were hospitalized after the index TAVR hospitalization with ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI). Patients with STEMI or NSTEMI with or without prior TAVR from the same time period were compared for the use of coronary angiography, revascularization, and in-hospital outcomes. Propensity score matching was used to account for imbalances in patient characteristics. RESULTS: Among 206,229 patients who underwent TAVR, the incidence of STEMI was 25 events per 100,000 person-years of follow-up, and that of NSTEMI was 229 events per 100,000 person-years. After propensity matching, the use of coronary revascularization was similar in the prior TAVR and no TAVR cohorts in both the STEMI (65.3% vs 63.9%; P = 0.81) and NSTEMI (41.4% vs 41.7%; P = 0.88) subgroups. Compared with patients without prior TAVR, in-hospital mortality was higher in the prior TAVR cohort in patients with STEMI (27.1% vs 16.7%; P = 0.03) and lower in those with NSTEMI (5.8% vs 8.2%; P = 0.02). CONCLUSIONS: In this large, national retrospective study, AMI events after TAVR were infrequent. There were no differences in the use of coronary revascularization for STEMI or NSTEMI in TAVR patients compared with the non-TAVR population. In-hospital mortality for STEMI is higher in TAVR patients compared with those without prior TAVR.

Five-Year Follow-Up from the CoreValve Expanded Use Transcatheter Aortic Valve-in-Surgical Aortic Valve Study.

Transcatheter aortic valve replacement (TAVR) provides an option for extreme-risk patients who underwent reoperation for a failed surgical aortic bioprosthesis. Long-term data on patients who underwent TAVR within a failed surgical aortic valve (TAV-in-SAV) are limited. The CoreValve Expanded Use Study evaluated patients at extreme surgical risk who underwent TAV-in-SAV. Outcomes at 5 years were analyzed by SAV failure mode (stenosis, regurgitation, or combined). Echocardiographic outcomes are site-reported. TAV-in-SAV was attempted in 226 patients with a mean age of 76.7 ± 10.8 years; 63.3% were male, the Society of Thoracic Surgeons predicted risk of mortality score was 9.0 ± 6.7%, and 87.5% had a New York Heart Association classification III or IV symptoms. Most of the failed surgical bioprostheses were stented (81.9%), with an average implant duration of 10.2 ± 4.3 years. The 5-year all-cause mortality or major stroke rate was 47.2% in all patients; 54.4% in the stenosis, 37.6% in the regurgitation, and 38.0% in the combined groups (p = 0.046). At 5 years, all-cause mortality was higher in patients with versus without 30-day severe prosthesis-patient mismatch (51.7% vs 38.3%, p = 0.026). The overall aortic valve reintervention rate was 5.9%; highest in the regurgitation group (12.6%). The mean aortic valve gradient was 14.1 ± 9.8 mm Hg and effective orifice area was 1.57 ± 0.70 at 5 years. Few patients had >mild paravalvular regurgitation at 5 years (5.5% moderate, 0.0% severe). TAV-in-SAV with supra-annular, self-expanding TAVR continues to represent a safe and lasting intermediate option for extreme-risk patients who have appropriate sizing of the preexisting failed surgical valve. Clinical and hemodynamic outcomes were stable through 5 years.

Challenges and Controversies in Peer Review: JACC Review Topic of the Week.

The process of peer review has been the gold standard for evaluating medical science, but significant pressures from the recent COVID-19 pandemic, new methods of communication, larger amounts of research, and an evolving publication landscape have placed significant pressures on this system. A task force convened by the American College of Cardiology identified the 5 most significant controversies associated with the current peer-review process: the effect of preprints, reviewer blinding, reviewer selection, reviewer incentivization, and publication of peer reviewer comments. Although specific solutions to these issues will vary, regardless of how scientific communication evolves, peer review must remain an essential process for ensuring scientific integrity, timely dissemination of information, and better patient care. In medicine, the peer-review process is crucial because harm can occur if poor-quality data or incorrect conclusions are published. With the dramatic increase in scientific publications and new methods of communication, high-quality peer review is more important now than ever.

Feasibility of Coronary Access Following Redo-TAVR for Evolut Failure: A Computed Tomography Simulation Study.

BACKGROUND: Coronary accessibility following redo-transcatheter aortic valve replacement (redo-TAVR) is increasingly important, particularly in younger low-risk patients. This study aimed to predict coronary accessibility after simulated Sapien-3 balloon-expandable valve implantation within an Evolut supra-annular, self-expanding valve using pre-TAVR computed tomography (CT) imaging. METHODS: A total of 219 pre-TAVR CT scans from the Evolut Low-Risk CT substudy were analyzed. Virtual Evolut and Sapien-3 valves were sized using CT-based diameters. Two initial Evolut implant depths were analyzed, 3 and 5 mm. Coronary accessibility was evaluated for 2 Sapien-3 in Evolut implant positions: Sapien-3 outflow at Evolut node 4 and Evolut node 5. RESULTS: With a 3-mm initial Evolut implant depth, suitable coronary access was predicted in 84% of patients with the Sapien-3 outflow at Evolut node 4, and in 31% of cases with the Sapien-3 outflow at Evolut node 5 (P<0.001). Coronary accessibility improved with a 5-mm Evolut implant depth: 97% at node 4 and 65% at node 5 (P<0.001). When comparing 3- to 5-mm Evolut implant depth, sinus sequestration was the lowest with Sapien-3 outflow at Evolut node 4 (13% versus 2%; P<0.001), and the highest at Evolut node 5 (61% versus 32%; P<0.001). CONCLUSIONS: Coronary accessibility after Sapien-3 in Evolut redo-TAVR relates to the initial Evolut implant depth, the Sapien-3 outflow position within the Evolut, and the native annular anatomy. This CT-based quantitative analysis may provide useful information to inform and refine individualized preprocedural CT planning of the initial TAVR and guide lifetime management for future coronary access after redo-TAVR. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02701283.

Impact of the COVID-19 Pandemic on Infective Endocarditis Management and Outcomes: Analysis of a National Clinical Database.

COVID-19 has widely affected health care delivery, but its impact on the management of infective endocarditis (IE), including valve surgery, is uncertain. We compared the national trends in admissions, demographics, and outcomes of IE before and after COVID-19 onset, using a national sample of IE admissions between 2016 and 2022 from the Vizient Clinical Database. The pre-COVID-19 and post-COVID-19 time periods were separated by the start of the second quarter of 2020, the time during which the COVID-19 pandemic was declared. For all admissions and for admissions involving valve surgery, pre-COVID-19 versus post-COVID-19 baseline characteristics and outcomes were compared using 2-sample t tests or chi-square tests. Propensity score-matched cohorts were similarly compared. Before COVID-19, there were 82,867 overall and 11,337 valve-related surgical admissions, and after COVID-19, there were 45,672 overall and 6,322 valve-related surgical admissions. In the matched analysis for all admissions, the in-hospital mortality increased from 11.4% to 12.4% after COVID-19 onset (p <0.001); in-hospital stroke (4.9% vs 6.0%, p <0.001), myocardial infarction (1.3% vs 1.4%, p = 0.03), and aspiration pneumonia (1.8% vs 2.4%, p <0.001) also increased, whereas other complications remained stable. In the matched analysis of surgical admissions, there was decreased in-hospital mortality (7.7% vs 6.7%, p = 0.03) and intensive care unit stay (8.5 ± 12.5 vs 8.0 ± 12.6 days, p = 0.04); other outcomes remained stable. In conclusion, patients admitted with IE after COVID-19 were more medically complex with worsened outcomes and mortality, whereas patients who underwent valve surgery had stable outcomes and improved mortality despite the pandemic.

Cardiac catheterization, coronary intervention, and wait times for transcatheter aortic valve replacement.

OBJECTIVES: Prolonged wait times for transcatheter aortic valve replacement (TAVR) are associated with increased morbidity and mortality. The incidence and predictors of short TAVR wait times (STWT: defined as ≤ 30 days from referral to TAVR procedure) have not been defined. This study examined the impact of clinical characteristics, demographics, and pre-TAVR cardiac catheterization on wait times for TAVR. METHODS: This was a retrospective observational analysis of 831 patients with severe aortic stenosis undergoing TAVR from 2019 to mid-2022 at the University of Vermont Medical Center. Demographics, timing of treatment [stratified by COVID-19 onset (1 March 2020)], TAVR center travel distance, baseline clinical factors, and process-related variables were analyzed to determine univariate STWT predictors (P < 0.10). Multivariable analysis was performed to determine independent STWT predictors. RESULTS: Approximately 50% of TAVR patients in this study achieved a STWT. The proportion of patients with STWT was higher (54.7% vs. 45.2%; P = 0.008) after the onset of COVID-19 pandemic. STWT was not related to travel distance (P = 0.61). Patients with left ventricular ejection fraction (LVEF) > 60% were less likely to achieve STWT compared to patients with LVEF < 40% (OR 0.45, P = 0.003). Patients who required catheterization or percutaneous coronary intervention (PCI) before TAVR were significantly less likely to achieve STWT (OR 0.65, P = 0.01). CONCLUSION: TAVR wait times were not affected by the COVID-19 pandemic or single rural TAVR center travel distance. Sicker patients were more likely to achieve STWT while catheterization/PCI before TAVR was associated with longer wait times.

Trends and Predictors of Short Length of Stay Following Transcatheter Aortic Valve Replacement.

BACKGROUND: Minimalist approaches to Transcatheter aortic valve replacement (TAVR) have allowed for improved efficiency in care of patients. We hypothesized that improved efficiencies in care process may have led to increased adoption of a one night length of stay (LOS) in this patient group. OBJECTIVES: The authors aimed to study temporal trends in short length of stay following TAVR. METHODS: This is a nationwide temporal trends study using the 2016-2019 National In Patient Sample (NIS) registry. Short stay was defined as LOS of one night or less. Trends in proportion of patients with short stay were obtained. A multivariate model to identify predictors of short stay was built after adjusting for confounders. Secondary analysis of temporal trends was stratified by presence or absence of major complications (major bleeding requiring transfusion or pacemaker implantation [PPMI]). RESULTS: A total of 217,110 patients were included in the weighted sample. The proportion of patients with short stay significantly increased for those with and without complications (Ptrend < 0.001). The morbidity burden, as defined by the proportion of patients with a Charlson comorbidity index (CCI) score of ≥2 and rate of major complications decreased significantly. On multivariate analysis short stay was predicted by male sex, white ethnicity, Southern/Western regions and lower CCI score. Patients with major bleeding requiring transfusion or PPMI were less likely to have short stay (aOR 0.23 and aOR 0.12, p < 0.001 respectively). CONCLUSION: There is a national trend towards shorter LOS following TAVR. There is a decrease in major post procedural complication rates from 2016 to 2019.

Multicenter experience with valve-in-valve transcatheter aortic valve replacement compared with primary, native valve transcatheter aortic valve replacement.

BACKGROUND: Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) offers an alternative to reoperative surgical aortic valve replacement. The short- and intermediate-term outcomes after ViV TAVR in the real world are not entirely clear. PATIENTS AND METHODS: A multicenter, retrospective analysis of a consecutive series of 121 ViV TAVR patients and 2200 patients undergoing primary native valve TAVR from 2012 to 2017 at six medical centers. The main outcome measures were in-hospital mortality, 30-day mortality, stroke, myocardial infarction, acute kidney injury, and pacemaker implantation. RESULTS: ViV patients were more likely male, younger, prior coronary artery bypass graft, "hostile chest," and urgent. 30% of the patients had Society of Thoracic Surgeons risk score <4%, 36.3% were 4%-8% and 33.8% were >8%. In both groups many patients had concomitant coronary artery disease. Median time to prosthetic failure was 9.6 years (interquartile range: 5.5-13.5 years). 82% of failed surgical valves were size 21, 23, or 25 mm. Access was 91% femoral. After ViV, 87% had none or trivial aortic regurgitation. Mean gradients were <20 mmHg in 54.6%, 20-29 mmHg in 30.6%, 30-39 mmHg in 8.3% and ≥40 mmHg in 5.87%. Median length of stay was 4 days. In-hospital mortality was 0%. 30-day mortality was 0% in ViV and 3.7% in native TAVR. There was no difference in in-hospital mortality, postprocedure myocardial infarction, stroke, or acute kidney injury. CONCLUSION: Compared to native TAVR, ViV TAVR has similar peri-procedural morbidity with relatively high postprocedure mean gradients. A multidisciplinary approach will help ensure patients receive the ideal therapy in the setting of structural bioprosthetic valve degeneration.

Concordance of Guideline-Based Risk Stratification and Selection of Patients for Transcatheter Aortic Valve Implantation or Surgical Replacement.

The 2020 American Health Association/American College of Cardiology valve guidelines recommend surgical aortic valve replacement (SAVR) for symptomatic patients with aortic stenosis (AS) age <65 years and transcatheter aortic valve implantation (TAVI) for patients with AS age >80 years. We analyzed TAVI versus SAVR practice patterns using age-based recommendations. We compared 2016-to-2019 TAVI and isolated SAVR in northern New England at 5 centers according to guideline-recommended age groups. Multivariable logistic regression was performed to identify independent predictors of TAVI for the intermediate age group. The study was approved by each site's institutional review board in accordance with ongoing participation and quality improvement efforts in the Northern New England Cardiovascular Study Group. Among 4,161 patients with isolated severe AS, TAVI increased from 2016 to 2019: 55.8% versus 76.1%, p <0.01 for trend. SAVR for patients with AS age >80 years was uncommon and decreased over time: 13.1% versus 1.6%, p <0.01. TAVI utilization nearly doubled over time in young patients with AS age <65 years (14.3% vs 26.2%, p <0.01). Preference for SAVR decreased by 50% over time (p <0.01) in the intermediate age group (65 to 80 years). Independent predictors of TAVI among patients aged 65 to 80 years included older age, chronic obstructive pulmonary disease, previous stroke, and coronary artery bypass grafting, whereas vascular disease and clinical urgency favored SAVR. In conclusion, consistent with current American Health Association/American College of Cardiology guidelines, TAVI was the treatment of choice in >97% of severe patients with AS age >80 years by 2019. TAVI utilization in patients <65 years has doubled over time and thus may not reflect current guideline recommendations. TAVI is the preferred choice in those aged 65 to 80 years, especially among patients with previous stroke or coronary artery bypass grafting.

Optical coherence tomography in coronary atherosclerosis assessment and intervention.

Since optical coherence tomography (OCT) was first performed in humans two decades ago, this imaging modality has been widely adopted in research on coronary atherosclerosis and adopted clinically for the optimization of percutaneous coronary intervention. In the past 10 years, substantial advances have been made in the understanding of in vivo vascular biology using OCT. Identification by OCT of culprit plaque pathology could potentially lead to a major shift in the management of patients with acute coronary syndromes. Detection by OCT of healed coronary plaque has been important in our understanding of the mechanisms involved in plaque destabilization and healing with the rapid progression of atherosclerosis. Accurate detection by OCT of sequelae from percutaneous coronary interventions that might be missed by angiography could improve clinical outcomes. In addition, OCT has become an essential diagnostic modality for myocardial infarction with non-obstructive coronary arteries. Insight into neoatherosclerosis from OCT could improve our understanding of the mechanisms of very late stent thrombosis. The appropriate use of OCT depends on accurate interpretation and understanding of the clinical significance of OCT findings. In this Review, we summarize the state of the art in cardiac OCT and facilitate the uniform use of this modality in coronary atherosclerosis. Contributions have been made by clinicians and investigators worldwide with extensive experience in OCT, with the aim that this document will serve as a standard reference for future research and clinical application.

Cost-effectiveness analysis of a resource-intensive approach versus minimally invasive strategy for high-risk transcatheter aortic valve replacement patients.

Aortic stenosis has a high mortality rate in patients who do not receive aortic valve replacement. Previously, transcatheter aortic valve replacement (TAVR) was an intervention reserved for individuals deemed high-risk for surgery. Since that time, TAVR has increasingly been offered to lower risk patients, yet it is unclear whether TAVR will meet an acceptable cost-effectiveness threshold in this group. In this cost-effectiveness study, we employed a decision tree model with Monte Carlo probability sensitivity analysis to determine the incremental cost (in US$) per quality-adjusted life year (QALY) and life year (LY) of performing the TAVR procedure using the resource-intensive approach versus the minimally invasive strategy in high-risk surgical patients.