Search

Objectives: To examine whether percutaneous alcohol septal ablation affects coronary flow reserve (CFR) in patients with hypertrophic cardiomyopathy (HCM). Methods: CFR was measured immediately before and after septal ablation in patients with symptomatic obstructive HCM. CFR was also obtained in normal subjects (NL) for comparison. Results: Patients with HCM (n = 11), compared with NL (n = 22), had a lower mean (SD) baseline CFR (1.96 (0.5) vs 3.0 (0.7), p<0.001), a lower coronary resistance (1.04 (0.45) vs 3.0 (2.6), p = 0.002), a higher coronary diastolic/systolic velocity ratio (DSVR; 5.1 (3.0) vs 1.8 (0.5), p = 0.04) and a lower hyperaemic coronary flow per left ventricular (LV) mass (0.73 (0.4) vs 1.1 (0.6) ml/min/g, p = 0.007). Septal ablation in the HCM group (n = 7) reduced the outflow tract gradient but not the left atrial or LV diastolic pressures. Ablation resulted in immediate normalisation of CFR (to 3.1 (1), p = 0.01) and DSVR (to 1.9 (0.8), p = 0.09) and an increase in coronary resistance (to 1.91 (0.6), p = 0.02). This was probably related to an improvement in the systolic coronary flow. Conclusions: This study demonstrates that successful septal ablation in patients with symptomatic HCM results in immediate improvement in CFR, which is reduced in HCM partly because of the increased systolic contraction load. [ABSTRACT FROM AUTHOR]

Objectives: Slow flow phenomenon is a serious complication of percutaneous coronary intervention (PCI) and is associated with a poor prognosis. We sought to evaluate the characteristics of lesions predisposing to the slow/no-reflow phenomenon during primary PCI in patients with acute myocardial infarction. Methods: The study subjects consisted of 57 consecutive patients (mean age 58.5 (SD 14.5) years, 45 males) who underwent primary PCI for acute myocardial infarction and intravascular ultrasound-virtual histology (IVUS-VH) examination. Slow flow was defined as Results: Slow flow developed in 12 patients (eight males). Patients with slow flow were likely to be older (67.5 (13.8) years vs 56.2 (13.9) years, p = 0.015), had more cardiogenic shock (16.7% vs 2.2%, p = 0.046), larger fibrofatty volume over the entire lesion length (36.7 (25.5) mm(3) vs 18.0 (18.6) mm(3), p = 0.006), higher remodelling index (1.10 (0.17) vs 0.99 (0.16), p = 0.043), larger plaque area (16.2 (5.4) mm(2) vs 12.5 (4.9) mm(2), p = 0.025), fibrous area (8.0 (3.3) mm(2) vs 5.4 (3.0) mm(2), p = 0.014) and fibrofatty area (2.7 (2.2) mm(2) vs 1.3 (1.6) mm(2), p = 0.016) at the minimal lumen site than those without slow flow (37 males). Multivariate analysis revealed that the fibrofatty volume over the entire lesion length was the only independent factor (beta = 0.359, 95% confidence interval 0.002 to 0.012, p = 0.006) for slow flow during primary PCI. Conclusions: This study suggests that slow flow may be dependent on the tissue characterisation (fibrofatty volume) of the underlying lesion at the time of the primary PCI for acute myocardial infarction. [ABSTRACT FROM AUTHOR]

Objectives: Our aim was to examine whether gender-based differences in mortality after percutaneous coronary interventions (PCIs) have changed in the past 25 years.Background: Women with coronary artery disease have a higher risk of adverse outcomes after PCIs than do men. Recent temporal trends in short-term and long-term mortality in women after PCIs are unknown.Methods: We performed a retrospective cohort study of 18,885 consecutive, unique patients who underwent PCIs between 1979 and 1995 (early group, n = 7,904, 28% women) and between 1996 and 2004 (recent group, n = 10,981, 31% women). Thirty-day and long-term mortality were compared by gender.Results: Compared with men, women undergoing PCIs were older and more likely to have diabetes mellitus, hypertension, or hypercholesterolemia. Overall, PCI was successful in 89% of women and 90% of men. In the recent group, 30-day mortality was significantly reduced compared with that in the early group in women (2.9% vs. 4.4%, p = 0.002) and men (2.2% vs. 2.8%, p = 0.04). However, long-term survival was similar between the early and recent groups among both men and women. After adjustment for risk factors, there was no difference between men and women from 1994 onward for either 30-day or long-term outcomes.Conclusions: The 30-day mortality after PCI in men and women has decreased in the past 25 years. After accounting for baseline risks, no differences in short-term or long-term mortality were observed between men and women. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To derive risk models for percutaneous coronary intervention (PCI) outcomes from clinical and laboratory variables available before the procedure so they can be used for preprocedure risk stratification. PATIENTS AND METHODS: Using the Mayo Clinic registry, we analyzed 9035 PCIs on 7640 unique patients from January 1, 2000, through April 30, 2005. We included only the first PCI per patient (n=7457). Logistic regression was used to model the calculated risk score and major procedural complications. Separate risk models were made for mortality and major adverse cardiovascular events (MACE) derived solely from baseline and laboratory characteristics. Final risk scores for procedural death, defined as any death during the index hospitalization, and MACE contained the same 7 variables (age, myocardial infarction less than or equal to 24 hours, preprocedural shock, serum creatinine level, left ventricular ejection fraction, congestive heart failure, and peripheral artery disease). RESULTS: Models had adequate goodness of fit, and areas under the receiver operating characteristic curve were 0.74 and 0.89 for MACE and procedural death, respectively, indicating excellent overall discrimination. The model was robust across many subgroups, including those undergoing elective PCI, those having diabetes mellitus, and elderly patients. Bootstrap analysis indicated that the model was not overfit to the available data set. CONCLUSION: Before coronary angiography is performed, a risk-scoring system based on 7 variables can be used conveniently to predict cardiovascular complications after PCI. This model may be useful for providing patients with individualized, evidence-based estimates of procedural risk as part of the informed consent process. [ABSTRACT FROM AUTHOR]

BACKGROUND: Low procedural complication rates, barriers to access, and patient preference have encouraged the development of percutaneous coronary intervention (PCI) programs at centers that are often closer to home but without on-site cardiac surgical capability. OBJECTIVES: We compared clinical and economic outcomes associated with performing low-risk elective PCI at a community hospital without on-site cardiac surgery with those obtained at a more remote tertiary care center with on-site cardiac surgery. DESIGN AND MEASURES: We matched 257 patients undergoing low-risk, elective PCI at a community hospital (Immanuel St. Joseph's Hospital [ISJ] between January 27, 2000, and July 31, 2002) to 514 PCI patients treated at a tertiary care hospital (Saint Marys Hospital [SMH] between January 27, 2000, and April 30, 2002) based on clinical and lesion criteria. Clinical outcomes (in-hospital procedural success and target vessel failure during long-term follow up) and economic outcomes (direct medical costs, billed charges, and hospital length of stay [LOS]) were compared between groups. The Mayo Clinic PCI Registry (containing clinical, angiographic, and follow-up data) and administrative data were used in matching and outcomes assessment. RESULTS: Procedural success was achieved more often among ISJ-treated patients (99% vs. 95%; P = 0.02); however, no difference in target vessel failure rates was observed during a median follow-up time of 3.1 years (estimated 1-year event rate: 15.2% vs. 14.8%; P = 0.46). ISJ-treated patients incurred, on average, $3024 more in estimated total costs ($13,771 vs. $10,746; P < 0.001) and $6084 more in billed charges (P < 0.001), but incurred similar LOS post procedure (1.53 days). CONCLUSIONS: Similar clinical outcomes were achieved at a community hospital without on-site cardiac surgery but at significantly increased direct medical cost. Patients, providers, hospitals, payers, and policymakers should consider whether the benefits associated with locally provided specialized cardiovascular services warrant this additional cost. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To determine the clinical and angiographic characteristics of patients who underwent coronary artery bypass graft (CABG) surgery before the availability of drug-eluting stents (DES) and to project the potential impact of percutaneous coronary intervention using DES. PATIENTS AND METHODS: We reviewed the coronary angiograms obtained between March 1999 and December 2001 of 192 consecutive patients from Olmsted County, Minnesota, who had undergone isolated CABG surgery for the first time. Three interventional cardiologists categorized the patients into 1 of 4 groups on the basis of technical feasibility of complete revascularization by percutaneous coronary intervention with DES. RESULTS: The study population consisted primarily of men (78%), with a mean age of 67 years. Of the 192 patients, 58 (30%) had diabetes mellitus, and 124 (65%) had 3-vessel disease. Twelve patients (6%) had lesions suitable for stents that matched the inclusion criteria for DES in recently published trials; 77 (40%) had lesions suitable for stents but had lesion characteristics not included in the initial DES trials. Thirty-two patients (17%) had target lesions considered technically difficult, but feasible, for stent placement. Seventy-one patients (37%) had lesions unsuitable for percutaneous coronary intervention (75% of these due to chronic occlusions) with the current stent delivery technology. CONCLUSION: This population-based analysis suggests that only a small proportion of patients undergoing CABG surgery meets the strict angiographic eligibility criteria for DES on the basis of recent trials. However, up to 46% of current CABG patients may ultimately undergo conversion to DES. The remaining 54% of this patient population may still not be ideal candidates for DES with the current stent delivery technology. [ABSTRACT FROM AUTHOR]

Endomyocardial biopsy (EMB) is widely used for surveillance of cardiac allograft rejection and for the diagnosis of unexplained ventricular dysfunction. Typically, EMB is performed through the jugular or femoral veins and is associated with a serious acute complication rate of less than 1% using current flexible bioptomes. Although it is accepted that EMB should be used to monitor for rejection after transplant, use of EMB for the diagnosis of various myocardial diseases is controversial. Diagnosis of myocardial disease in the nontransplant recipient is often successful via noninvasive investigations including laboratory evaluation; echocardiography, nuclear studies, and magnetic resonance imaging can yield specific diagnoses in the absence of invasive EMB. Therefore, use of the technique is patient specific and depends on the potential prognostic and treatment information gained by establishing a pathologic diagnosis beyond noninvasive testing. [ABSTRACT FROM AUTHOR]

Coronary artery disease (CAD) is the single most common cause of death in the developed world, responsible for about 1 in every 5 deaths. The morbidity, mortality, and socioeconomic importance of this disease make timely accurate diagnosis and cost-effective management of CAD of the utmost importance. This comprehensive review of the literature highlights key elements in the diagnosis, risk stratification, and management strategies of patients with chronic CAD. Relevant articles were identified by searching the PubMed database for the following terms: chronic coronary artery disease or stable angina. Novel imaging modalities, pharmacological treatment, and invasive (percutaneous and surgical) interventions have revolutionized the current treatment of patients with chronic CAD. Medical treatment remains the cornerstone of management, but revascularization continues to play an important role. In the current economic climate and with health care reform very much on the horizon, the issue of appropriate use of revascularization is important, and the indications for revascularization, in addition to the relative benefits and risks of a percutaneous vs a surgical approach, are discussed. [ABSTRACT FROM AUTHOR]

Objectives: To determine the frequency of urgent coronary angiography in patients with acute pericarditis and to examine clinical characteristics associated with coronary angiography.Patients and Methods: This is a retrospective analysis of all incident cases of acute viral or idiopathic pericarditis evaluated at Mayo Clinic's site in Rochester, MN, between January 1, 2000, and December 31, 2006. The main outcome measures were use of urgent coronary angiography and rate of concomitant coronary artery disease in patients with pericarditis.Results: There were 238 patients with a final diagnosis of acute pericarditis (mean age, 47.7+/-17.9 years; 157 [66.0%] were male). On the initial electrocardiogram, 146 patients (61.3%) had ST-segment elevation, and 92 (38.7%) had no ST-segment elevation. Coronary angiography was performed in 40 patients (16.8% of all patients); the frequency was 5-fold higher among those with ST-segment elevation (24.7% vs 4.3%; P<.001). Additionally, 7 patients (4.8%) with ST-segment elevation received thrombolytics before transfer to our institution; no patients without ST-segment elevation received thrombolysis (P=.05). Characteristics associated with a higher likelihood of coronary angiography included typical anginal chest pain, ST-segment elevation, previous percutaneous coronary intervention, elevated troponin T values, diaphoresis, and male sex. Coronary angiography revealed concomitant mild to moderate coronary artery disease in 14 (35.0%) of the 40 patients who underwent this procedure.Conclusion: Urgent coronary angiography is commonly performed in patients with acute pericarditis, particularly those with ST-segment elevation, typical myocardial infarction symptoms, and elevated troponin T values. Coronary artery disease was present angiographically in one-third of patients undergoing the procedure. Although patients with ST-segment elevation myocardial infarction must receive prompt reperfusion, clinicians must also consider the diagnosis of pericarditis to avoid unneeded coronary angiography. [ABSTRACT FROM AUTHOR]

Frailty is a geriatric syndrome characterized by functional impairments and is associated with poor outcomes; however, the prevalence of frailty and its association with health status in patients treated with percutaneous coronary intervention (PCI) are unknown. To assess the prevalence of frailty and its association with health status in PCI-treated patients, we studied 629 patients ≥65 years old undergoing PCI from October 2005 through September 2008. Frailty was characterized using the Fried criteria: weight loss >10 lbs. in previous 1 year, exhaustion, low physical activity, poor gait speed, and poor grip strength (3 features = frail; 1 feature to 2 features = intermediate frailty; 0 feature = not frail). Health status was assessed using the Short-Form 36 and the Seattle Angina Questionnaire (SAQ). Multivariable linear regression models were used to estimate the independent association between frailty and health status. Complete data on 545 patients demonstrated that 19% (n = 117) were frail, 47% (n = 298) had intermediate frailty, and 21% (n = 130) were not frail. Frail patients had more co-morbidities and more frequent left main coronary artery or multivessel disease after adjusting for age and gender (p <0.05 across groups). Multivariable linear regression demonstrated poorer health status in frail patients compared to nonfrail patients as evidenced by lower Short-Form 36 scores, lower SAQ scores for physical limitation, and lower SAQ scores for quality of life (p <0.001 for each health status domain). In conclusion, 1/5 of older patients are frail at the time of PCI and have greater comorbid burden, angiographic disease severity, and poorer health status than nonfrail adults. [ABSTRACT FROM AUTHOR]

Myocarditis, an inflammatory disease of heart muscle, is an important cause of dilated cardiomyopathy worldwide. Viral infection is also an important cause of myocarditis, and the spectrum of viruses known to cause myocarditis has changed in the past 2 decades. Several new diagnostic methods, such as cardiac magnetic resonance imaging, are useful for diagnosing myocarditis. Endomyocardial biopsy may be used for patients with acute dilated cardiomyopathy associated with hemodynamic compromise, those with life-threatening arrhythmia, and those whose condition does not respond to conventional supportive therapy. Important prognostic variables include the degree of left and right ventricular dysfunction, heart block, and specific histopathological forms of myocarditis. We review diagnostic and therapeutic strategies for the treatment of viral myocarditis. English-language publications in PubMed and references from relevant articles published between January 1, 1985, and August 5, 2008, were analyzed. Main keywords searched were myocarditis, dilated cardiomyopathy, endomyocardial biopsy, cardiac magnetic resonance imaging, and immunotherapy. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To study clinical outcomes in patients given glycoprotein (GP) IIb/IIIa inhibitors with concomitant clopidogrel at the time of ad hoc percutaneous coronary interventions (PCI). PATIENTS AND METHODS: We studied 30-day and long-term outcomes of patients undergoing elective or urgent PCI from March 1, 1998, to December 31, 2006, stratified by administration of GP IIb/IIIa inhibitors with concomitant clopidogrel treatment at the time of ad hoc PCI. RESULTS: The mean+/-SD age was 66.3+/-11.9 years in 5196 patients receiving compared with 67.8+/-11.8 years in 4681 patients not receiving a GP IIb/IIIa inhibitor (P<.001). Overall, 30-day unadjusted mortality was lower in patients who received a GP IIb/IIIa inhibitor (1.0% vs 1.2%; P=.22). Long-term mortality was significantly lower (P<.001) in patients receiving GP IIb/IIIa inhibitors at the time of PCI. After propensity analysis to adjust for the likelihood of receiving GP IIb/IIIa inhibitors on the basis of clinical, angiographic, and procedural characteristics, a significant reduction in 30-day mortality with GP IIb/IIIa inhibitor use was identified (hazard ratio, 0.56; 95% confidence interval, 0.36-0.87; P=.01). Kaplan-Meier analysis (median follow-up, 48 months) revealed a significant improvement in long-term survival in patients receiving a GP IIb/IIIa inhibitor at the time of ad hoc PCI that persisted after propensity adjustments (hazard ratio, 0.88; 95% confidence interval, 0.79-0.98; P=.021). Patients treated with drug-eluting stents showed a significant improvement in adjusted long-term mortality. CONCLUSION: In patients undergoing elective or urgent ad hoc PCI, coadministration of a GP IIb/IIIa inhibitor and dual antiplatelet therapy is associated with reduced risk-adjusted 30-day and long-term mortality. [ABSTRACT FROM AUTHOR]

Objective: To compare outcomes among patients receiving eptifibatide or abciximab during primary percutaneous coronary intervention (PCI) for acute myocardial infarction (MI) with ST elevation or new left bundle branch block.Patients and Methods: From January 1999 through January 2004, 576 patients underwent primary PCI and received adjunctive glycoprotein IIb/IIIa receptor antagonists. Propensity scores were used to adjust for baseline differences between groups. Logistic regression and Cox proportional hazards were used to model the association between choice of glycoprotein IIlb/IIIa receptor antagonist and adverse events.Results: Abciximab was given to 327 patients (57%) and eptifibatide to 249 (43%). Observed rates of in-hospital death or MI did not differ between groups (eptifibatide, 6%; abciximab, 5%; P = .95). This result persisted with adjustment for various patient characteristics (adjusted odds ratio, 1.03; 95% confidence interval, 0.40-2.65; P = .95). Kaplan-Meier estimated rates of death, MI, or target vessel revascularization at 1-year follow-up were 20.9% with eptifibatide and 22.3% with abciximab. The adjusted hazard ratio for the composite end point during a median follow-up of 12 months was 1.36 (95% confidence interval, 0.89-2.07; P = -.16).Conclusion: In this observational analysis, outcomes were similar with use of either abciximab or eptifibatide among patients undergoing primary PCI for acute MI. Additional comparative research is warranted to confirm these results. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To compare the short-term and long-term outcomes of patients with coronary artery disease and peripheral arterial disease (PAD) who underwent intracoronary (IC) stent Implantation during percutaneous coronary intervention (PCI) with the outcomes of patients with isolated coronary artery disease but without PAD who underwent IC stent implantation. PATIENTS AND METHODS: We analyzed the outcomes of 7696 patients who underwent IC stent implantation during PCI at the Mayo Clinic in Rochester, Minn, between January 1996 and December 2002. Outcomes of 6299 patients (82%) with Isolated coronary artery disease and without PAD who underwent IC stent implantation (group 1) were compared with outcomes of 1397 patients (18%) with coronary artery disease and PAD (group 2) who underwent PCI with IC stent implantation. RESULTS: Patients in group 2 were older (71.1+/-10.2 years vs 65.0+/-12.0 years; P<.001) and had a higher prevalence of hypertension (79% vs 61%; P<.001), diabetes mellitus (33% vs 20%; P<.001), hyperlipidemia (76% vs 70%; P<.001), and history of smoking (70% vs 63%; P<.001) compared with group 1. Prevalence of multivessel disease was higher in group 2 (79% vs 68%; P<.001). Procedural success was significantly lower In group 2 (95% vs 97%; P<.001). In-hospital complications were higher in group 2: death (3% vs 1%; P<.001), any myocardial Infarction (MI) (8% vs 5%; P<.001), death/MI/coronary artery bypass grafting (CABG)/target vessel revascularization (11% vs 7%; P<.001), and blood loss requiring transfusion (11% vs 5.8%; P<.001). After adjustment for other risk factors, the odds ratio for in-hospital death was 1.84 (95% confidence interval [CI], 1.16-2.90; P=.009), and for death/MI/CABG/target vessel revascularization, the odds ratio was 1.25 (95% CI, 1.00-1.55; P=.048) in patients with PAD treated with IC stents. Median follow-up was 3.1 years. Six-month, 1-year, and 2-year Kaplan-Meier estimates of survival free of death/MI/CABG/target vessel revascularization were 84%, 77%, and 69%, respectively, for group 2 and were significantly worse compared with group 1 (89%, 85%, and 80%, respectively; P<.001). This effect remained after adjustment for other risk factors (hazard ratio, 1.36; 95% CI, 1.22-1.51). CONCLUSIONS: Compared with patients who had isolated coronary artery disease but no PAD, patients with coronary artery disease and PAD had lower procedural success and higher in-hospital major cardiovascular complications, including higher blood loss requiring transfusion, after PCI with stent Implantation. On follow-up, the short-term and long-term outcomes of patients with PAD were worse, with higher mortality, MI, and need for repeated target vessel revascularization. [ABSTRACT FROM AUTHOR]

Background: The perception of takotsubo syndrome (TTS) has evolved significantly over the years, primarily driven by increased recognition of acute complications and mortality., Objectives: This study aimed to explore temporal trends in demographic patterns, risk factors, clinical presentations, and outcomes in patients with TTS., Methods: Patients diagnosed with TTS between 2004 and 2021 were enrolled from the InterTAK (International Takotsubo) registry. To assess temporal trends, patients were divided into 6 groups, each corresponding to a 3-year interval within the study period., Results: Overall, 3,957 patients were included in the study. There was a significant demographic transition, with the proportion of male patients rising from 10% to 15% (P = 0.003). Although apical TTS remained the most common form, the diagnosis of midventricular TTS increased from 18% to 28% (P = 0.018). The prevalence of physical triggers increased from 39% to 58% over the years (P < 0.001). There was a significant increase in 60-day mortality over the years (P < 0.001). However, a landmark analysis excluding patients who died within the first 60 days showed no differences in 1-year mortality (P = 0.150)., Conclusions: This study of temporal trends in TTS highlights a transition in patients demographic with a growing prevalence among men, increasing recognition of midventricular TTS type, and increased short-term mortality and rates of cardiogenic shock in recent years. This transition aligns with the rising prevalence of physical triggers, as expression of increased recognition of TTS in association with acute comorbidities., Competing Interests: Funding Support and Author Disclosures Dr Templin has received institutional grants from Abbott Vascular, Medtronic, and SMT; and has received consulting grants from Biotronik, Microport, and Innova. Dr Airaksinen has received grants or has contracts with the Finnish Foundation for Cardiovascular Research; and has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Bayer, Pfizer, Boehringer Ingelheim, and AstraZeneca. Dr Bauersachs has received grants from or has contracts with Abiomed, CVRx, Norgine, Roche, and Zoll; holds patents PCT/EP2007/008772 and PCT/EP2009/051986 for microRNA and downstream targets for diagnostics and therapeutic purposes; has received consulting fees from Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Cardior, Corvia, CVRx, Edwards, Norgine, Novartis, Pfizer, Roche, and Vifor; and has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Cardior, CVRx, Norgine, Novartis, Pfizer, and Vifor. Dr Boehm has received grants from or has contracts with Deutsche Forschungsgemeinschaft research support (DFG, SFB-TTR 219, S-01); has received speaker honoraria from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cytokinetics, Medtronic, Novartis, Servier, and Vifor; and is on the advisory board of Amgen, Bayer, Boehringer Ingelheim, Cytokinetics, Medtronic, Novartis, Pfizer, ReCor, Servier, and Vifor. Dr Ferreira has received payments for lectures, presentations, speakers bureaus, manuscript writing, or educational events from A Menarini, Medinfar, Bayer, AstraZeneca, Biotronik, and Medtronic; and has received payments for participation on a Data Safety Monitoring Board or Advisory Board from Medtronic. Dr Dichtl has received consulting fees from Reata. Dr Kaiser has received consulting fees from the Swiss Federal Office of Public Health; and has received support for attending meetings and/or travel from Medtronic, Abbott, and Europa Organization. Dr Kobza has received institutional grants on behalf of the Luzerner Kantonsspital from Biosense Webster, Boston Scientific, Biotronik, Medtronik, and Sis-Medical; and has received consulting fees from Biosense Webster, Biotronik, and Medtronic. Dr Koenig has received grants and provision of reagents to the institution from Singulex, Dr.Beckmann Pharma, Abbott, and Roche Diagnostics; has received consulting fees from AstraZeneca, Novartis, Amgen, Pfizer, The Medicines Company, DalCor Pharmaceuticals, Kowa, Corvidia Therapeutics, OMEICOS, Daiichi-Sankyo, Novo Nordisk, New Amsterdam Pharma, TenSixteen Bio, Esperion, and Genentech; and has received lecture fees from Bristol Myers Squibb, Novartis, Amgen, Berlin-Chemie, Sanofi, and AstraZeneca. Dr Lüscher has received research or educational grants to the institution from Abbott, Amgen, AstraZeneca, Boehringer Ingelheim, Daiichi-Sankyo, Novartis, Novo Nordisk, Sanofi, and Vifor; is the president elect of the European Society of Cardiology; is chairman of the research committee of the Swiss Heart Foundation; is President of the Board of the Zurich Heart House; and is Trustee of the London Heart House. Dr Karakas has received grants or has contracts with Vifor Pharma and Daiichi-Sankyo; has received consulting fees or payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Vifor, Pharmacosmos, and Sphingotec; and has received equipment, materials, drugs, medical writing, gifts or other services from Sphingotec and Vifor Pharma. Dr Niederseer has received consulting fees from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi-Sankyo, Gerson Lehmann Group (GLG) Consulting, Novo Nordisk, Pfizer and Zoll; has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi-Sankyo, Novartis, Novo Nordisk, and Pfizer; and has received support for attending meetings and/or travel from Abbott, Amgen, Bayer, and Novo Nordisk. Dr Roffi has received institutional research grants from Boston Scientific, Cordis, Terumo, Biotronik, and Medtronic. Dr Ruschitzka has not received personal payments by pharmaceutical companies or device manufacturers in the last 3 years; the Department of Cardiology (University Hospital of Zurich/University of Zurich), however, reports research, educational, and/or travel grants from Abbott, Abiomed, Alexion, Amgen, AstraZeneca, At the Limits Ltd, Bayer, Berlin Heart, B. Braun, Biosense Webster, Biosensors Europe AG, Biotronik, Bristol Myers Squibb, Boehringer Ingelheim, Boston Scientific, Bracco, Cardinal Health Switzerland, Concept Medical, Corteria, CSL, Daiichi-Sankyo, Diatools AG, Edwards Lifesciences, Guidant Europe NV, Hamilton Health Sciences, IHF, Innosuisse, Johnson/Johnson, Kaneka Corporation, Kantar, Kiniksa, Labormedizinisches Zentrum, MedAlliance, Medical Education Global Solutions, Medtronic, MicroPort, MSD, Mundipharma Medical Company, Novartis, Novo Nordisk, Orion, Pfizer, Quintiles Switzerland Sarl, RecorMedical, Roche Diagnostics, Roche Pharma, Sahajanand IN, Sanofi, Sarstedt AG, Servier, SIS Medical, Sorin CRM SAS, SSS International Clinical Research, Stromal, Terumo Deutschland, Trama Solutions, V-Wave, Vascular Medical, Vifor, Wissens Plus, and ZOLL. Prof Ruschitzka has not received personal payments by pharmaceutical companies or device manufacturers in the last 3 years; remuneration for the time spent in the following consulting activities were made directly to the University of Zurich and do not impact on his personal remuneration: AstraZeneca (IMC), Bayer, Boehringer Ingelheim, Citi Research, Klub Class, Novo Nordisk, Radcliffe Group, Stiftung Pfizer Forschungspreis, and Vifor; remuneration for the following lectures were made directly to the University of Zurich and do not impact on his personal remuneration: Abbott, Amgen, AstraZeneca (A+ Science AB), Bayer (At the Limits), Boehringer Ingelheim, Boston Scientific (CCE Services), Brigham and Women’s Hospital Boston, C.T.I GmbH, FomF, Hôpitaux Universitaires des Genève (GECORE), Luzerner Kantonsspital, Sanofi-Aventis, Servier, Medcon, Medscape (WebMD), Medtronic, Medworld, Novartis, Roche, Ruwag, Swiss Heart Failure Academy, The Hong Kong Heart Failure Society, Trama Solutions SL, Inselspital Bern, Charité–Universitätsmedizin Berlin (Medical Education Global Solutions), Romanian Society of Cardiology, ÖKG Österreichische Gesellschaft für Kardiologie, and Zoll; has received support for attending meetings and/or travel from AstraZeneca (IMC/A+ Science AB), Boehringer Ingelheim, Centro Hospitaler de Vila Nova de Gaia, C.T.I. GmbH (Universitätsklinikum Düsseldorf), European Society of Cardiology, Monocle, Novartis, Spektar Putovanja, Austrian Heart Failure Association, and Heart Failure Association of the ESC; remuneration for following Advisory Boards were made directly to the University of Zurich and do not impact on his personal remuneration: Bayer, Roche, IMC/AstraZeneca, and Amgen; and he has received secretarial and administrative support of the HFA for his role as President/Past-President for 2018 to 2020. Dr Schunkert has received consulting fees from Amgen, Daiichi-Sankyo, Merck Sharp and Dohme, AstraZeneca, Bayer, Boehringer Ingelheim, Novartis, and Servier; has received honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events and support for attending meetings and/or travel from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi-Sankyo, Merck Sharp and Dohme, Novartis, Sanofi Aventis, Servier, and Synlab; and has received honoraria for his participation on a Data Safety Monitoring Board or Advisory Board of Boehringer Ingelheim, Daiichi-Sankyo, Novartis, and Amgen. Dr Wolfrum has received consulting fees from NVT/Biosensors as well as payments for lectures, presentations, speakers bureaus, manuscript writing, or educational events from NVT/Biosensors; and has equities in Hi-D Imaging, Winterthur, Switzerland. Dr Crea has received personal fees from Amgen, AstraZeneca, Abbott, Menarini, Chiesi, and Daiichi-Sankyo, outside of the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Patients with aortic stenosis (AS) and cardiogenic shock (CS) are an extremely high-risk population with a poor prognosis in the absence of definitive therapy., Aims: To compare the outcomes of transcatheter aortic valve replacement (TAVR) with surgical AVR (SAVR) in patients with AS-CS., Methods: We queried the Nationwide Readmission Database (2016-2021) to identify patients hospitalized for AS-CS who underwent isolated TAVR or SAVR. In-hospital outcomes of TAVR vs SAVR were compared using multivariable regression and propensity-matching analyses. Ninety-day readmissions were compared using Cox proportional hazards regression model., Results: Of 16,072 patients hospitalized for AS-CS, 6,381 (39.7%) underwent isolated TAVR, and 9,691 (60.3%) underwent isolated SAVR. From 2016 through 2021, the proportion of TAVR increased from 29.5% to 46.5% and the proportion of SAVR correspondingly decreased in AS-CS (ptrend<0.01). After adjustment for baseline characteristics, TAVR was associated with lower odds of stroke (adjusted odds ratio [aOR] 0.59, 95% confidence interval [CI] 0.44-0.79), acute kidney injury (aOR 0.79, 95% CI 0.68-0.92), and major bleeding (aOR 0.54, 95% CI 0.40-0.72) and higher odds of vascular complications (aOR 1.55, 95% CI 1.22-1.96) compared with SAVR. In-hospital mortality, myocardial infarction, permanent pacemaker placement, and 90-day all-cause and heart failure readmissions were similar. Length of stay was shorter and total costs and nonhome discharges were lower with TAVR., Conclusions: This nationwide observational analysis showed that TAVR is increasingly performed in patients with AS-CS and is associated with similar in-hospital mortality and 90-day readmissions, but lower in-hospital complications and resource utilization compared with SAVR., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Objective: To evaluate whether major adverse cardiac events (MACE) continue to be a major causative factor for mortality after noncardiac surgery., Patients and Methods: We performed retrospective study of 75,410 adult noncardiac surgery patients at Mayo Clinic Rochester, between January 1, 2016, and May 4, 2018. Electronic medical records were reviewed and data collected on all deaths within 30 days (n=692 patients) of surgery. The incidence of death due to MACE was calculated., Results: Postoperative MACE occurred in 150 patients (21.4 events per 10,000 patients; 95% CI, 18.2-25.2 events per 10,000 patients) with most occurring within 3 days of surgery (n=113). Postoperative MACE events were associated with atrial fibrillation with rapid rate response in 25 patients (16.7%), sepsis in 15 patients (10%), and bleeding in 15 patients (10%). There were 12 intraoperative deaths of which 9 were due to exsanguination (75%) and the remaining 3 (25%) due to cardiac arrest. Of the 56 deaths on the first 24 hours after surgery, 7 were due to hemorrhage, 17 due to cardiovascular causes, 20 due to sepsis, and 7 due to neurologic disease. The leading cause of total death over 30 days postoperatively was sepsis (28%), followed by malignancy (27%), cardiovascular disease (12%) neurologic disease (12%), and hemorrhage (5%)., Conclusion: MACE was not the leading cause of death both intraoperatively and postoperatively., Competing Interests: The authors report no competing interests., (© 2024 The Authors.)

Background: Previous transcatheter valve therapy registry analyses of transcatheter mitral valve in valve (MViV) replacement of degenerated bioprosthesis reported early experience in the United States. Given recent increases in transseptal MViV volumes and introduction of the SAPIEN 3 Ultra valve, it is important to determine contemporary outcomes for patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV replacement., Methods: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry was used to extract data for all patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV from 2015 to September 2022. Primary efficacy outcome was 1-year all-cause mortality. Secondary end points included 30-day mortality, functional class, quality of life, and mitral valve performance. Primary safety outcomes were device success and in-hospital complications., Results: A total of 4243 patients with a mean STS score of 9.2±7.7 underwent transseptal MViV at 455 sites. The rate of Mitral Valve Academic Research Consortium technical (96.6%) success was high, and procedural complications were low. All-cause in-hospital, 30-day, and 1-year mortality rates were 3.2%, 4.3%, and 13.4%, respectively. Significant improvements in New York Heart Association class (New York Heart Association I/II, 18% to 87%) and quality of life (Kansas City Cardiomyopathy Questionnaire score, 38 to 78) were noted at 1 year ( P <0.0001 for both) after MViV. Upon stratifying by STS scores, it was observed that the low-risk group (STS<4) had a significantly lower in-hospital mortality rate of 0.4%, whereas the intermediate-risk group (STS, 4-8) had an in-hospital mortality rate of 1.9%. From 2015 to 2022, the number of transseptal MViV cases/year increased significantly, whereas procedure times, length of stay, and intensive care unit hours shortened significantly. At the same time, there was a significant trend toward reduced in-hospital ( P =0.0005), 30-day ( P =0.004), and 1-year mortality rates ( P =0.01)., Conclusions: This multicenter, prospective study reports excellent procedural outcomes, 1-year mortality rates, and a significant improvement in quality of life for patients undergoing transseptal MViV in the contemporary era. Patients in the low-risk and intermediate-risk STS score categories had significantly better outcomes compared with those in the high-risk category. MViV is a reasonable therapy for the majority of patients with degenerated bioprosthetic mitral valves, who are anatomical candidates.

Background: A significant proportion of patients requiring mitral valve (MV) intervention have undergone prior coronary artery bypass grafting (CABG). Reoperative heart surgery is associated with increased risk., Aims: To evaluate the utilization and outcomes of transcatheter versus surgical MV interventions in patients with prior CABG., Methods: We queried the Nationwide Readmission Database (2016-2021) to identify adults with prior CABG hospitalized for transcatheter or surgical MV intervention. In-hospital outcomes were compared using multivariable regression and propensity-matching analyses. Readmissions were compared using Cox proportional hazards regression model., Results: Of 305,625 weighted hospitalizations for MV intervention, 23,506 (7.7%) occurred in patients with prior CABG. From 2016-2021, the use of transcatheter MV interventions increased among patients with prior CABG (72 to 191 for repair and 6 to 45 for replacement per 100,000 hospitalizations, both ptrend<0.001). Compared with surgical MV repair and replacement, transcatheter MV repair and replacement were associated with similar in-hospital mortality (adjusted odds ratio [aOR] 0.44, 95% confidence interval [CI] 0.20-1.03 for repair; aOR 0.61, 95% CI 0.38-1.02 for replacement) and 180-day heart failure readmissions (adjusted hazard ratio [aHR] 1.56, 95% CI 0.85-2.87 for repair; aHR 1.15, 95% CI 0.63-2.09 for replacement) and lower stroke, acute kidney injury, permanent pacemaker placement, length of stay, and nonhome discharges, respectively. Vascular complications were higher with transcatheter versus surgical MV replacement., Conclusions: Transcatheter MV interventions are increasingly used as the preferred modality of MV intervention in patients with prior CABG and are associated with similar in-hospital mortality and 180-day heart failure readmissions compared with surgical MV interventions., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Purpose: Chronic kidney disease (CKD) is a risk factor for ischemic and bleeding events with dual antiplatelet therapy after percutaneous coronary intervention (PCI). Whether the presence of CYP2C19 loss of function (LOF) alleles modifies this risk, and whether a genotype-guided (GG) escalation of P2Y 12 inhibitor therapy post PCI is safe in this population is unclear., Methods: This was a post hoc analysis of randomized patients in TAILOR PCI. Patients were divided into two groups based on estimated glomerular filtration rate (eGFR) threshold of < 60 ml/min/1.73 m 2 for CKD (n = 539) and non-CKD (n = 4276). The aggregate of cardiovascular death, stroke, myocardial infarction, stent thrombosis, and severe recurrent coronary ischemia at 12-months post-PCI was assessed as the primary endpoint. Secondary endpoint was major or minor bleeding., Results: Mean (standard deviation) eGFR among patients with CKD was 49.5 (8.4) ml/min/1.72 m 2 . Among all patients, there was no significant interaction between randomized strategy and CKD status for any endpoint. Among LOF carriers, the interaction between randomized strategy and CKD status on composite ischemic outcome was not significant (p = 0.2). GG strategy was not associated with an increased risk of bleeding in either CKD group., Conclusions: In this exploratory analysis, escalation of P2Y 12 inhibitor therapy following a GG strategy did not reduce the primary outcome in CKD. However, P2Y 12 inhibitor escalation following a GG strategy was not associated with increased bleeding risk in CKD. Larger studies in CKD are needed., Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT01742117?term=TAILOR-PCI&draw=2&rank=1 . NCT01742117., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Conduction disease is an important and common complication post-transcatheter aortic valve replacement (TAVR). Previously, we developed a conduction disease risk stratification and management protocol post-TAVR. This study aims to evaluate high-grade aortic valve block (HAVB) incidence and risk factors in a large cohort undergoing ambulatory cardiac monitoring post-TAVR according to conduction risk grouping., Methods: This single-center, retrospective study evaluated all patients discharged on ambulatory cardiac monitoring between 2016 and 2021 and stratified them into 3 groups based on electrocardiogram predictors of HAVB risk (group 1 [low], group 2 [intermediate], and group 3 [high]). HAVB was defined as ≥2 consecutive nonconducted P waves in sinus rhythm or bradycardia <50 beats/minute with a fixed rate for atrial fibrillation/flutter. Descriptive statistics were used to show the incidence and timeline, while logistic regression was utilized to evaluate predictors of HAVB., Results: Five hundred twenty-eight patients were included (median age 80 years [74-85]; 43.8% female). Forty-one patients (7.8%) developed HAVB during ambulatory monitoring (68% were asymptomatic). Over a median follow-up of 2 years (1.3-2.7), the overall mortality rate was 15.0% (30-day mortality rate of 0.57%, n = 3). Risk factors for HAVB were male sex (odds ratio [OR] = 2.46, p = 0.02, 95% CI = 1.21-5.43), baseline right bundle branch block (OR = 2.80, p = 0.01, 95% CI = 1.17-6.19), and post-TAVR QRS >150 ​ms (OR = 2.16, p = 0.03, 95% CI = 1.01-4.40). The negative predictive value for patients in groups 1 and 2 for 30-day HAVB was 95.0 and 93.8%, respectively., Conclusions: The risk of 30-day HAVB post-TAVR on ambulatory monitoring post-TAVR varies according to post-TAVR electrocardiogram findings, and a 3-group algorithm effectively identifies groups with a low negative predictive value for HAVB., Competing Interests: The authors report no conflict of interest., (© 2024 The Authors.)

Background: Data on the prognostic factors after mitral valve (MV) transcatheter edge-to-edge repair (TEER; MV-TEER) are limited. Pulsed-wave Doppler interrogation of pulmonary vein flow (PVF) is a convenient method to assess the hemodynamic burden of residual mitral regurgitation (MR), which could be of utility as a predictor of outcomes., Methods: Patients that underwent MV-TEER between May 2014 and December 2021 at our institution were evaluated. Pulmonary vein flow patterns post-MV-TEER were reviewed on the procedural transesophageal echocardiogram and classified as normal (systolic dominant or codominant) or abnormal (systolic blunting or reversal). The PVF pattern was correlated with all-cause mortality at follow-up., Results: Two-hundred sixty-five patients had diagnostic PVF post-MV-TEER, with 73 (27.5%) categorized as normal and 192 (72.5%) categorized as abnormal. Patients with abnormal PVF morphology were more likely to have atrial fibrillation (70% vs 42%, P < .001) and greater than moderate residual MR (16% vs 3%, P = .01) and had higher mean left atrial pressure (18.1 ± 5.0 vs 15.9 ± 4.2 mm Hg, P = .002) and left atrial V wave (26.6 ± 8.5 vs 21.4 ± 7.3 mm Hg, P < .001) postprocedure. In multivariable analysis, abnormal PVF morphology post-MV-TEER was independently associated with mortality at follow-up (hazard ratio = 1.70; 95% CI, 1.06-2.74; P = .03) after correction for end-stage renal disease, atrial fibrillation, and residual MR. Results were similar in subgroups of patients with moderate or less and those with mild or less residual MR., Conclusions: Pulmonary vein flow morphology is a simple and objective tool to assess MR severity immediately post-MV-TEER and offers important prognostic information to optimize procedural results. Additional studies are needed to determine whether patients with abnormal PVF pattern post-MV-TEER would benefit from more intensive goal-directed medical therapy postprocedure., Competing Interests: Conflicts of Interest None., (Copyright © 2024 American Society of Echocardiography. Published by Elsevier Inc. All rights reserved.)

Background: Adequate valve performance after surgical mitral valve repair with an annuloplasty ring is not always sustained over time. The risk of repeat mitral valve surgery may be high in these patients. Transcatheter mitral valve-in-ring (MViR) is emerging as an alternative for high-risk patients., Objectives: The authors sought to assess contemporary outcomes of MViR using third-generation balloon-expandable aortic transcatheter heart valves., Methods: Patients who underwent MViR and were enrolled in the STDS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between August 2015 and December 2022 were analyzed., Results: A total of 820 patients underwent MViR at 236 sites, mean age was 72.2 ± 10.4 years, 50.9% were female, mean STS score was 8.2% ± 6.9%, and most (78%) were in NYHA functional class III to IV. Mean left ventricular ejection fraction was 47.8% ± 14.2%, mean mitral gradient was 8.9 ± 7.0 mm Hg, and 75.5% had ≥ moderate mitral regurgitation. Access was transseptal in 93.9% with 88% technical success. All-cause mortality at 30 days was 8.3%, and at 1 year, 22.4%, with a reintervention rate of 9.1%. At 1-year follow-up, 75.6% were NYHA functional class I to II, Kansas City Cardiomyopathy Questionnaire score increased by 25.9 ± 29.1 points, mean mitral valve gradient was 8.4 ± 3.4 mm Hg, and 91.7% had ≤ mild mitral regurgitation., Conclusions: MViR with third-generation balloon-expandable aortic transcatheter heart valves is associated with a significant reduction in mitral regurgitation and improvement in symptoms at 1 year, but with elevated valvular gradients and a high reintervention rate. MViR is a reasonable alternative for high-risk patients unable undergo surgery who have appropriate anatomy for the procedure. (STS/ACC TVT Registry Mitral Module [TMVR]; NCT02245763)., Competing Interests: Funding Support and Author Disclosures As this analysis was restricted to the Edwards Lifesciences SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra Resilis transcatheter heart valves, statistical analyses were performed by Edwards Lifesciences. The views or opinions presented here do not represent those of the American College of Cardiology (ACC), Society of Thoracic Surgeons (STS), or the STS/ACC TVT Registry. Dr Guerrero has received institutional research grant support from Abbott Structural Heart and Edwards Lifesciences. Dr Bapat has received speaker/consultancy fees and research grant support from Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, and 4C Medical. Dr Mahoney has served as a consultant for Edwards Lifesciences and Medtronic. Dr Eng has served as a clinical proctor for Edwards Lifesciences and Medtronic. Dr Yadav has served as a consultant for Edwards Lifesciences, Medtronic Inc., Abbott Vascular, and Shockwave Medical. Dr Coylewright has received research funding from Boston Scientific and Edwards Lifesciences; and consulting fees from Medtronic, Abbott, Occlutech, Boston Scientific, and Edwards Lifesciences. Dr Makkar has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific; has served as national principal investigator for Portico (Abbott) and Acurate (Boston Scientific) U.S. investigation device exemption trials; has received personal proctoring fees from Edwards Lifesciences; and has received travel support from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Szerlip has served as National Principal Investigator for trial sponsored by Edwards Lifesciences; has served on steering committees for trials by Abbott and Medtronic; and has served as speaker for Medtronic, Abbott, and Edwards Lifesciences. Dr Nazif has received consulting fees or honoraria from Boston Scientific, Medtronic, Opsens Medical, Teleflex, and Encompass Technologies and institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott. Dr. Kodali is a consultant for Admedus, Meril Lifesciences, JenaValve, Abbott Vascular; and has equity in Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve Inc, Supira, and Admedus. Dr. George has served as a consultant for Cardiomech, Atricure, Valcare Medical, Mitremedical, Ethicon, Zimmer Biomet, Durvena, and Vdyne. Drs Greenbaum and Babaliaros have received institutional research support from Abbott Vascular, Ancora Heart, Edwards Lifesciences, Gore Medical, Jena Valve, Medtronic, Polares Medical, Transmural Systems, and 4C Medical; received consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic; and have equity interest in Transmural Systems. Dr Whisenant has served as a consultant for Edwards Lifesciences. Dr Thourani has been an advisor for Abbott Vascular, ARtivion, Atricure, Boston Scientific, Edwards Lifesciences, Medtronic, and Shockwave. Dr McCabe has served as a consultant for Edwards, Medtronic, Boston Scientific, and Cardiovascular System Inc; and has equity in ConKay Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)