Computed tomography derived anatomical predictors of vascular access complications following transfemoral transcatheter aortic valve implantation: A systematic review.

BACKGROUND: Vascular complications after percutaneous transfemoral transcatheter aortic valve implantation (TAVI) are associated with adverse clinical outcomes and remain a significant challenge. AIMS: The purpose of this review is to synthesize the existing evidence regarding the iliofemoral artery features predictive of vascular complications after TAVI on pre-procedural contrast-enhanced multidetector computed tomography (MDCT). METHODS: A systematic search was performed in Embase and Medline (Pubmed) databases. Studies of patients undergoing transfemoral TAVI with MDCT were included. Studies with only valve-in-valve TAVI, planned surgical intervention and those using fluoroscopic assessment were excluded. Data on study cohort, procedural characteristics and significant predictors of vascular complications were extracted. RESULTS: We identified 23 original studies involving 8697 patients who underwent TAVI between 2006 and 2020. Of all patients, 8514 (97.9%) underwent percutaneous transfemoral-TAVI, of which 8068 (94.8%) had contrast-enhanced MDCT. The incidence of major vascular complications was 6.7 ± 4.1% and minor vascular complications 26.1 ± 7.8%. Significant independent predictors of major and minor complications related to vessel dimensions were common femoral artery depth (>54 mm), sheath-to-iliofemoral artery diameter ratio (>0.91-1.19), sheath-to-femoral artery diameter ratio (>1.03-1.45) and sheath-to-femoral artery area ratio (>1.35). Substantial iliofemoral vessel tortuosity predicted 2-5-fold higher vascular risk. Significant iliofemoral calcification predicted 2-5-fold higher risk. The iliac morphology score was the only hybrid scoring system with predictive value. CONCLUSIONS: Independent iliofemoral predictors of access-site complications in TAVI were related to vessel size, depth, calcification and tortuosity. These should be considered when planning transfemoral TAVI and in the design of future risk prediction models.

Association of endogenous sex hormone levels with tooth loss due to periodontitis in men and post-menopausal women: The multi-ethnic study of atherosclerosis.

AIM: To investigate the association between endogenous sex hormone levels and history of tooth loss related to periodontitis in healthy middle-aged to older men and post-menopausal women. METHODS: This cross-sectional study included 5649 participants aged 45-84 (mean age, 63 ± 10 years) from the Multi-Ethnic Study of Atherosclerosis cohort who had sex hormone levels measured and answered a questionnaire regarding perceived periodontal status at exam 1. Multivariable logistic regression was used to examine the association of sex hormones (exposure) with history of tooth loss (outcome), stratified by sex. RESULTS: Among post-menopausal women, higher free testosterone (per 1SD) was associated with a greater prevalence of tooth loss [OR 1.49 (95% CI, 1.08-2.05)], whereas higher sex hormone binding globulin (SHBG) was associated with a lower prevalence of tooth loss [OR 0.74 (0.58-0.94)], after adjustment for cardiometabolic risk factors and reproductive factors. In men, higher free testosterone and lower SHBG were associated with a lower prevalent probability of tooth loss in unadjusted analysis, but these associations lost significance after covariate adjustment. CONCLUSION: A higher androgenic sex hormone profile in post-menopausal women (i.e., increased free testosterone, lower SHBG) was associated with an increased prevalence of tooth loss, after adjusting cardiometabolic risk factors. No such association was found in men. These findings suggest that sex hormones may influence or serve as a marker for periodontal health.

Clinical outcomes following single access transfemoral transcatheter aortic valve implantation.

OBJECTIVES: We describe the first experience using calcification of anatomical landmarks to obviate the need for transcatheter aortic valve implantation (TAVI) alignment aortography and secondary TAVI access. BACKGROUND: TAVI alignment conventionally involves secondary femoral access for contrast aortography using a second catheter. Secondary femoral access accounts for up to 25% of all vascular complications. Heavily calcified aortic leaflets are often visible fluoroscopically and can act as markers for TAVI alignment. METHODS: We considered 100 consecutive patients for transfemoral TAVI. The first group was considered for a conventional dual access technique and the subsequent group was considered for a single access technique. Relevant baseline, and procedural and outcome measures were recorded. RESULTS: Baseline characteristics were comparable between groups. Balloon-expandable transcatheter heart valves (THV) were used in all cases. THV implantation was successful in 100% of cases with no procedural or in-hospital mortality. Procedural time and contrast use were lower in the single access group. There were no Valve Academic Research Consortium (VARC)-2 major vascular complications with the single access technique. CONCLUSIONS: This is the first study describing the use of calcification of anatomical landmarks to obviate the need for secondary TAVI access. Notable observations included successful device implantation in all cases, no VARC-2 major vascular complications, comparable rates of paravalvular leak and permanent pacemaker requirement, shorter procedural times, and lower contrast use. Single access TAVI is a viable alternative technique to minimize vascular access, contrast use, and procedural duration in experienced centers and with selected patients, allowing successful device implantation and low complication rates while further streamlining TAVI workflow.

Association of HIV infection with clinical features and outcomes of patients with aortic aneurysms.

Data on the characteristics and outcomes of hospitalized patients with aortic aneurysms (AA) and HIV remain scarce. This is a cohort study of hospitalized adult patients with a diagnosis of AA from 2013 to 2019 using the US National Inpatient Readmission Database. Patients with a diagnosis of HIV were identified. Our outcomes included trends in hospitalizations and comparison of clinical characteristics, complications, and mortality in patients with AA and HIV compared to those without HIV. Among 1,905,837 hospitalized patients with AA, 4416 (0.23%) were living with HIV. There was an overall age-adjusted increase in the rate of HIV among patients hospitalized with AA over the years (14-29 per 10,000 person-years; age-adjusted p-trend < 0.001). Patients with AA and HIV were younger than those without HIV (median age: 60 vs 76 years, p < 0.001) and were less likely to have a history of smoking, hypertension, dyslipidemia, diabetes mellitus, and obesity. Thoracic aortic aneurysms were more prevalent in those with HIV (37.5% vs 26.7%, p < 0.001). On multivariable logistic regression, HIV was not associated with increased risk of aortic rupture (OR: 0.79; 95% CI: 0.61-1.01, p = 0.06), acute aortic dissection (OR: 0.73; 95% CI: 0.51-1.06, p = 0.3), readmissions (OR: 1.04; 95% CI: 0.95-1.13, p = 0.4), or aortic repair (OR: 0.89; 95% CI: 0.79-1.00, p = 0.05). Hospitalized patients with AA and HIV had a lower crude mortality rate compared to those without HIV (OR: 0.75 (0.63-0.91), p = 0.003). Hospitalized patients with AA and HIV likely constitute a distinct group of patients with AA; they are younger, have fewer traditional cardiovascular risk factors, and a higher rate of thoracic aorta involvement. Differences in clinical features may account for the lower mortality rate observed in patients with AA and HIV compared to those without HIV.

COVID-19 risk index (CRI): a simple and validated emergency department risk score that predicts mortality and the need for mechanical ventilation.

Although certain risk factors have been associated with morbidity and mortality, validated emergency department (ED) derived risk prediction models specific to coronavirus disease 2019 (COVID-19) are lacking. The objective of this study is to describe and externally validate the COVID-19 risk index (CRI). A large retrospective longitudinal cohort study was performed to analyze consecutively hospitalized patients with COVID-19. Multivariate regression using clinical data elements from the ED was used to create the CRI. The results were validated with an external cohort of 1799 patients from the MI-COVID19 database. The primary outcome was the composite of the need for mechanical ventilation or inpatient mortality, and the secondary outcome was inpatient mortality. A total of 1020 patients were included in the derivation cohort. A total of 236 (23%) patients in the derivation cohort required mechanical ventilation or died. Variables independently associated with the primary outcome were age ≥ 65 years, chronic obstructive pulmonary disease, chronic kidney disease, cerebrovascular disease, initial D-dimer > 1.1 µg/mL, platelet count < 150 K/µL, and severity of SpO2:FiO2 ratio. The derivation cohort had an area under the receiver operator characteristic curve (AUC) of 0.83, and 0.74 in the external validation cohort Calibration shows close adherence between the observed and expected primary outcomes within the validation cohort. The CRI is a novel disease-specific tool that assesses the risk for mechanical ventilation or death in hospitalized patients with COVID-19. Discrimination of the score may change given continuous updates in contemporary COVID-19 management and outcomes.

Association of autosomal dominant polycystic kidney disease with cardiovascular disease: a US-National Inpatient Perspective.

PURPOSE: Data on the epidemiology of cardiovascular diseases (CVD) in patients with autosomal dominant polycystic kidney disease (ADPKD) are limited. In this study, we assess the prevalence of CVD in patients with ADPKD and evaluate associations between these two entities. METHODS: Using the National Inpatient Sample database, we identified 71,531 hospitalizations among adults aged ≥ 18 years with ADPKD, from 2006 to 2014 and collected relevant clinical data. RESULTS: The prevalence of CVD in the study population was 42.6%. The most common CVD were ischemic heart diseases (19.3%), arrhythmias (14.2%), and heart failure (13.1%). The prevalence of CVD increased with the severity of renal dysfunction (RD). We found an increase in hospitalizations of patients with ADPKD and CVD over the years (ptrend < 0.01), irrespective of the degree of RD. CVD was the greatest independent predictor of mortality in these patients (OR: 3.23; 95% CI 2.38-4.38 [p < 0.001]). In a propensity matched model of hospitalizations of patients with CKD with and without ADPKD, there was a significant increase in the prevalence of atrial fibrillation/flutter (AF), pulmonary hypertension (PHN), non-ischemic cardiomyopathy (NICM), and hemorrhagic stroke among patients with ADPKD when compared to patients with similar degree of RD without ADPKD. CONCLUSIONS: The prevalence of CVD is high among patients with ADPKD, and the most important risk factor associated with CVD is severity of RD. We found an increase in the trend of hospitalizations of patients with ADPKD associated with increased risk of AF, PHN, NICM, and hemorrhagic stroke. History of CVD is the strongest predictor of mortality among patients with ADPKD.

Incidence and clinical outcomes of bleeding complications and acute limb ischemia in STEMI and cardiogenic shock.

BACKGROUND: Bleeding complications and acute limb ischemia (ALI) are devastating vascular complications in patients with ST-segment elevation myocardial infarction (STEMI). Cardiogenic shock (CS) can further increase this risk due to multiorgan failure. In the contemporary era, percutaneous mechanical circulatory support is commonly used for management of CS. We hypothesized that vascular complications may be an important determinant of clinical outcomes for CS due to STEMI (CS-STEMI). OBJECTIVE: We evaluated 10-year national trends, resource utilization and outcomes of bleeding complications, and ALI in CS-STEMI. METHODS: We performed a retrospective cohort study of CS-STEMI patients from a large U.S. national database (National Inpatient Sample) between 2005 and 2014. Events were then divided into four different groups: no MCS, with intra-aortic balloon pump, percutaneous ventricular assist device includes Impella or Tandem Heart or extracorporeal membrane oxygenation. RESULTS: Bleeding complications and ALI were observed in 31,389 (18.2%) and 1,628 (0.9%) out of 172,491 admissions with CS-STEMI, respectively. Between 2005 and 2014, overall trends increased for ALI; however, the number of bleeding events decreased. ALI was associated with increased in-hospital mortality in comparison to those without any ALI. However, bleeding complications were not associated with increased in-hospital mortality. Compared to patients without complications, both bleeding and ALI were associated with increased length of stay (LOS) and hospitalization costs. CONCLUSIONS: Bleeding and ALI are common complications associated with CS-STEMI in the contemporary era. Both complications are associated with increased hospital costs and LOS. These findings highlight the need to develop algorithms focused on vascular safety in CS-STEMI.

Incidence and clinical outcomes of stroke in ST-elevation myocardial infarction and cardiogenic shock.

OBJECTIVE: The authors sought to evaluate 10-year national trends, incidence and clinical outcomes of stroke in CS-STEMI. BACKGROUND: Stroke is a devastating complication among patients with ST-elevation myocardial infarction (STEMI). Concomitant cardiogenic shock (CS) may further increase the risk of stroke. Use of percutaneous mechanical circulatory support (pMCS) devices may further increase stroke risk in CS-STEMI. No studies have evaluated the risk of stroke in contemporary CS-STEMI. METHODS: We performed a retrospective cohort study of CS-STEMI patients from a large U.S. national database between 2005 and 2014. Previously validated codes for stroke were used to identify events of ischemic or hemorrhagic stroke. They were then divided into different groups: without MCS, with intra-aortic balloon pump, percutaneous ventricular assist device (PVAD, includes Impella or TandemHeart devices), or extracorporeal membrane oxygenation. RESULTS: In 172,491 admissions, stroke was noted in 5,613 (3.2%). Between 2005 and 2014, we observed an increase in the events of overall stroke from 3.1% in 2005 to 5.0% in 2014 (p for the trend <.001). The number of ischemic stroke events (2.4%) was higher than hemorrhagic stroke (0.1%) during the study period. Presence of stroke was associated with higher in-hospital mortality (40.6 vs. 29.8%, 95% CI adjusted odds ratio: 1.57, 1.44-1.67; p < .0001 among stroke vs. without stroke). CONCLUSIONS: The incidence of stroke events in CS-STEMI patients increased between 2005 and 2014, and is associated with higher in-hospital mortality, length of stay, and cost of hospitalization. The incidence of both hemorrhagic and ischemic stroke was higher with pMCS device use. Stroke prevention is a priority for CS-STEMI patients.

Unmasking pulmonary hypertension following tricuspid valve replacement.

In this Viewpoint, we highlight a possible hemodynamic problem arising following tricuspid valve replacement (TVR) in patients with severe chronic tricuspid regurgitation, represented by "unmasking" of pulmonary hypertension (PH) following the surgery. We share an observation that should alert cardiologists to the fact that this increasingly utilized surgery is not risk free, and careful assessment of the right ventricular function and pulmonary circulation preoperatively is extremely important, especially in patients with preexisting risk factors for PH, since TVR may lead to a sudden increase in right ventricular afterload.

Transcatheter aortic valve implantation in acute decompensated aortic stenosis.

OBJECTIVES: To assess the safety and efficacy of first-line transcatheter aortic valve implantation (TAVI) in patients presenting with acute decompensated aortic stenosis (ADAS). BACKGROUND: ADAS is common and is often treated medically or using balloon aortic valvuloplasty in the first instance. This temporizing measure results in suboptimal outcomes. In the current era, TAVI provides an alternative option. METHODS: Consecutive patients who had either a TAVI for ADAS or electively were included in the study. The primary outcome was procedural and 30-day mortality and hospital length of stay (LOS). Secondary outcomes included 1-year mortality and procedural complications. RESULTS: Of note, 893 patients (mean age 83 ± 7, 50.5% male) underwent TAVI (19% ADAS, 81% elective). ADAS patients were more unwell with worse echocardiographic parameters than elective patients. ADAS patients of 55.9% were known to have significant aortic stenosis prior to their decompensation. Procedural mortality was not different between the ADAS and elective cohorts (1.2 vs. 0.7%; p = .62). The ADAS cohort had a higher 30-day mortality (5.3 vs. 1.1%; p = .002) and longer LOS (31.9 ± 20.7 days vs. 6.1 ± 6.5 days; p < .001). Multivariate analysis identified acute kidney injury and ADAS as significant predictors of 30-day mortality. CONCLUSIONS: TAVI for ADAS is safe and effective with procedural outcomes similar to elective patients. However, compared to elective patients, they have worse physiological baseline features, poorer prognosis at 30 days, and longer hospital admissions. Majority of patients who presented with ADAS were known to have AS prior to admission.

Trends in the Incidence of In-Hospital Mortality, Cardiogenic Shock, and Utilization of Mechanical Circulatory Support Devices in Myocarditis (Analysis of National Inpatient Sample Data, 2005-2014).

BACKGROUND: Myocarditis may be associated with hemodynamic instability and portends a poor prognosis when associated with cardiogenic shock (CS). There are limited data available on the incidence of in-hospital mortality, CS, and utilization of mechanical circulatory support (MCS) devices in these patients. METHODS: We queried the 2005-2014 National Inpatient Sample databases to identify all patients aged >18 years with myocarditis in the United States. RESULTS: The number of reported cases of myocarditis per 1 million gradually increased from 95 in 2005 to 144 in 2014 (Pfor trend <.01). The trend and incidence of endomyocardial biopsy remained the same despite the increase in clinical diagnosis. Overall, in-hospital mortality was 4.43% of total admissions without a change in overall trend over the study period. We also observed a significant increase in the incidence of CS from 6.94% in 2005 to 11.99% in 2014 (Pfor trend <.01). There was a parallel increase in the utilization of advanced MCS devices during the same time period such as extracorporeal membrane oxygenation or percutaneous cardiopulmonary support (0.32% in 2005 to 2.1% in 2014; P< .01) and percutaneous ventricular assist devices such as Impella/tandem heart (0.176% in 2005 to 1.75% in 2014; P< .01). CONCLUSION: Although the incidence of myocarditis has increased in the last decade, the in-hospital mortality has remained the same despite increases in the incidence of CS, possibly reflecting the benefits of increased usage of advanced MCS devices. We noted that increasing age, presence of multiple comorbidities and CS were associated with an increase in in-patient mortality.

Variations in the referral patterns to pharmacologic and exercise myocardial perfusion imaging.

BACKGROUND: Myocardial perfusion imaging (MPI) is commonly utilized for the non-invasive evaluation of patients with suspected coronary artery disease (CAD). It is either performed with exercise or pharmacologic stress. The objective of this study is to compare the referral patterns and diagnostic findings in patients referred for pharmacologic vs exercise MPI. METHODS AND RESULTS: This was a prospective study of 429 consecutive patients who were referred for MPI at the American University of Beirut Medical Center (23% had pharmacologic stress with dipyridamole and 77% had exercise stress testing). Patients referred to pharmacologic stress were older, had a higher percentage of women, and a higher prevalence of diabetes and hypertension. There were more abnormal scans in the pharmacologic stress group (38% vs 20%, P < 0.001), as well as a higher prevalence of ischemia (21% vs 13%, P < 0.001) and impaired left ventricular function with an ejection fraction < 50% (19% vs 7.9%, P < 0.001). The significant predictors for referral to pharmacologic stress by multivariable logistic regression analysis were older age (OR = 2.01 (1.57-2.57), P < 0.001) and diabetes (OR = 2.04 (1.19-3.49), P = 0.009). CONCLUSION: Patients referred for pharmacologic stress MPI are at a higher risk than those referred for exercise stress MPI with more CAD risk factors, older age, and a higher prevalence of abnormal MPI findings.

Interventions for smoking cessation in patients admitted with Acute Coronary Syndrome: a review.

Tobacco smoking contributes to about six million deaths per year and is predicted to increase in the future. Several pharmacological interventions are used for smoking cessation. Trials using nicotine replacement therapy (NRT) in acute coronary syndrome (ACS) showed inconclusive results. Furthermore, three trials using bupropion in patients admitted with ACS failed to show improvement in smoking cessation compared with placebo. Interestingly, only one trial using varenicline was successful in achieving smoking abstinence in the acute setting. With regard to behavioural interventions, a meta-analysis found that telephone counselling was successful in both the acute and stable settings, with greater effect in the acute setting. The best results for smoking cessation were found in trials that used a combination of pharmacological and behavioural interventions. The objective of this report is to review the results of studies on interventions used for smoking cessation after an ACS.

Reverse Takotsubo Cardiomyopathy and Cardiogenic Shock Associated With Methamphetamine Consumption.

BACKGROUND: Reverse Takotsubo cardiomyopathy is characterized by transient myocardial hypokinesia affecting predominantly the basal myocardial wall. It is a rare variant of Takotsubo cardiomyopathy affecting younger patients. CASE REPORT: We report a case of a young man who having consumed methamphetamines presented with cardiogenic shock and severe left ventricular systolic dysfunction, affecting predominantly the basal segments with sparing of the apex. After inotropic support, the left ventricular ejection fraction improved. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: It is important that emergency physicians are aware of the danger of methamphetamine consumption, and how it can lead to potentially fatal acute cardiac syndromes, including reverse Takotsubo cardiomyopathy and cardiogenic shock.

Age Is a Predictor of In-Hospital Outcomes for Left Ventricular Assist Device Implantation: A Nationwide Analysis.

The 2018 heart allocation system has significantly influenced heart transplantation and left ventricular assist device (LVAD) utilization. Our study aims to investigate age-related outcomes following LVAD implantation in the post-allocation era. Using the National Inpatient Sample, we analyzed data from 7375 patients who underwent LVAD implantation between 2019 and 2020. The primary endpoint was in-hospital mortality following LVAD implantation, stratified by age categories. The age groups were 18-49, 50-59, 60-69, and over 70. These represented 26%, 26%, 31%, and 17% of patients, respectively. Patients aged 60-69 and those over 70 exhibited higher in-hospital mortality rates of 12% and 17%, respectively, compared to younger age groups (7% for 18-49 and 6% for 50-59). The age groups 60-69 and over 70 were independent predictors of mortality, with adjusted odds ratios of 1.99 (p = 0.02; 95% confidence interval [CI], 1.12-3.57) and 2.88 (p = 0.002; 95% CI, 1.45-5.71), respectively. Additionally, a higher Charlson Comorbidity Index was associated with increased in-hospital mortality risk (adjusted odds ratio 1.39; p = 0.02; 95% CI, 1.05-1.84). Additionally, patients above 70 experienced a statistically shorter length of stay. Nonhome discharge was found to be significantly high across all age categories. However, the difference in hospitalization cost was not statistically significant across the age groups. Our study highlights that patients aged 60 and above face an increased risk of in-hospital mortality following LVAD implantation in the post-allocation era. This study sheds light on age-related outcomes and emphasizes the importance of considering age in LVAD patient selection and management strategies.

Contrast Volume-to-Estimated Glomerular Filtration Rate Ratio as a Predictor of Short-Term Outcomes Following Transcatheter Aortic Valve Implantation.

Background/Objectives: Contrast-induced acute kidney injury (AKI) is associated with early mortality and adverse events. However, in the setting of transcatheter aortic valve implantation (TAVI), previous literature has failed to establish a correlation between the absolute volume of contrast media administered and mortality. We aimed to investigate the impact of contrast volume administered normalised to estimated glomerular filtration rate (CV/eGFR) on the development of AKI and on 30-day all-cause mortality in TAVI patients. Methods: We retrospectively analysed a cohort of 1150 patients who underwent TAVI at our unit between 2015 and 2018. Results: Follow-up was complete for 1064 patients. There were 23 deaths within the follow-up period and 76 cases of AKI, 9 of which required new renal replacement therapy (RRT). Receiver-operating characteristic (ROC) curve analysis showed fair discrimination for 30-day all-cause mortality at a CV/eGFR ratio of 3.6 (area under the ROC curve (AUC) 0.671). Of patients in whom CV data were available, 86.0% (n = 757) had a CV/eGFR < 3.6 and 14.0% (n = 123) had a CV/eGFR ≥ 3.6. In multivariate logistic regression analysis, CV/eGFR ≥ 3.6 was the strongest predictor of 30-day all-cause mortality (odds ratio 5.06, 95% confidence interval [1.61-15.7], p = 0.004). Other independent predictors were procedural urgency (3.28 [1.04-10.3], p = 0.038) and being under general anaesthesia (4.81 [1.10-17.3], p = 0.023). CV/eGFR ≥ 3.6 was also independently associated with significantly increased odds of AKI (2.28 [1.20-4.17], p = 0.009) alongside significant non-left main stem coronary artery disease (2.56 [1.45-4.66], p = 0.001), and diabetes (1.82 [1.03-3.19], p = 0.037). In supplementary ROC curve analysis, a similar CV/eGFR cut point of 3.6 was found to be an excellent predictor for new RRT (AUC 0.833). Conclusions: In conclusion, a CV/eGFR ≥ 3.6 post-TAVI was found to be a strong predictor of 30-day mortality and AKI. The maximum contrast volume that can be safely administered in each patient without significantly increasing the risk of mortality and AKI can be calculated using this ratio.

Clinical Outcomes Among Immunotherapy-Treated Patients With Primary Cardiac Soft Tissue Sarcomas: A Multicenter Retrospective Study.

Background: Primary cardiac soft tissue sarcomas (CSTS) affect young adults, with dismal outcomes. Objectives: The aim of this study was to investigate the clinical outcomes of patients with CSTS receiving immune checkpoint inhibitors (ICIs). Methods: A retrospective, multi-institutional cohort study was conducted among patients with CSTS between 2015 and 2022. The patients were treated with ICI-based regimens. The Kaplan-Meier method was used to estimate overall survival (OS) and progression-free survival (PFS). Objective response rates were determined according to Response Evaluation Criteria in Solid Tumors version 1.1. Treatment-related adverse events were graded per the Common Terminology Criteria for Adverse Events version 5.0. Results: Among 24 patients with CSTS, 17 (70.8%) were White, and 13 (54.2%) were male. Eight patients (33.3%) had angiosarcoma. At the time of ICI treatment, 18 patients (75.0%) had metastatic CSTS, and 4 (16.7%) had locally advanced disease. ICIs were administered as the first-line therapy in 6 patients (25.0%) and as the second-line therapy or beyond in 18 patients (75.0%). For the 18 patients with available response data, objective response rate was 11.1% (n = 2 of 18). The median PFS and median OS in advanced and metastatic CSTS (n = 22) were 5.7 months (95% CI: 2.8-13.3 months) and 14.9 months (95% CI: 5.7-23.7 months), respectively. The median PFS and OS were significantly shorter in patients with cardiac angiosarcomas than in those with nonangiosarcoma CSTS: median PFS was 1.7 vs 11 months, respectively (P < 0.0001), and median OS was 3.0 vs 24.0 months, respectively (P = 0.008). Any grade treatment-related adverse events occurred exclusively in the 15 patients with nonangiosarcoma CSTS (n = 7 [46.7%]), of which 6 (40.0%) were grade ≥3. Conclusions: Although ICIs demonstrate modest activity in CSTS, durable benefit was observed in a subset of patients with nonangiosarcoma, albeit with higher toxicity.

Impact of Intraprocedural Mitral Regurgitation and Gradient Following Transcatheter Edge-to-Edge Repair for Primary Mitral Regurgitation.

BACKGROUND: The impact of intraprocedural results following transcatheter edge-to-edge repair (TEER) in primary mitral regurgitation (MR) is controversial. OBJECTIVES: This study sought to investigate the prognostic impact of intraprocedural residual mitral regurgitation (rMR) and mean mitral valve gradient (MPG) in patients with primary MR undergoing TEER. METHODS: The PRIME-MR (Outcomes of Patients Treated With Mitral Transcatheter Edge-to-Edge Repair for Primary Mitral Regurgitation) registry included consecutive patients with primary MR undergoing TEER from 2008 to 2022 at 27 international sites. Clinical outcomes were assessed according to intraprocedural rMR and mean MPG. Patients were categorized according to rMR (optimal result: ≤1+, suboptimal result: ≥2+) and MPG (low gradient: ≤5 mm Hg, high gradient: > 5 mm Hg). The prognostic impact of rMR and MPG was evaluated in a Cox regression analysis. The primary endpoint was 2-year all-cause mortality or heart failure hospitalization. RESULTS: Intraprocedural rMR and mean MPG were available in 1,509 patients (median age = 82 years [Q1-Q3: 76.0-86.0 years], 55.1% male). Kaplan-Meier analysis according to rMR severity showed significant differences for the primary endpoint between rMR ≤1+ (29.1%), 2+ (41.7%), and ≥3+ (58.0%; P < 0.001), whereas there was no difference between patients with a low (32.4%) and high gradient (42.1%; P = 0.12). An optimal result/low gradient was achieved in most patients (n = 1,039). The worst outcomes were observed in patients with a suboptimal result/high gradient. After adjustment, rMR ≥2+ was independently linked to the primary endpoint (HR: 1.87; 95% CI: 1.32-2.65; P < 0.001), whereas MPG >5 mm Hg was not (HR: 0.78; 95% CI: 0.47-1.31; P = 0.35). CONCLUSIONS: Intraprocedural rMR but not MPG independently predicted clinical outcomes following TEER for primary MR. When performing TEER in primary MR, optimal MR reduction seems to outweigh the impact of high transvalvular gradients.