BACKGROUND: The CardioMEMS HF System is a wireless pulmonary artery pressure monitoring device approved for heart failure management. While clinical trials have demonstrated favorable safety profiles, comprehensive post-...BACKGROUND: The CardioMEMS HF System is a wireless pulmonary artery pressure monitoring device approved for heart failure management. While clinical trials have demonstrated favorable safety profiles, comprehensive post-market surveillance analyses of real-world adverse event reports remain limited. METHODS: All adverse event reports for the CardioMEMS HF System were extracted from the FDA MAUDE database. Descriptive analyses, diversity indices, Pareto analyses, disproportionality measures (Proportional Reporting Ratio [PRR] and Reporting Odds Ratio [ROR]), and co-occurrence network analyses with community detection were performed using R version 4.3.3. RESULTS: A total of 5468 MAUDE reports were analyzed. The vast majority (98.0%) were classified as device malfunctions, with 110 reports (2.0%) designated as serious events. Patient-problem coding was dominated by administrative "no-impact" descriptors (97.9%). The most frequent device problems, including Material Frayed, Device Displays Incorrect Message, and Sparking, are attributable to the external home electronics unit rather than the implanted sensor and were not disproportionately associated with serious outcomes. Disproportionality analysis identified safety signals for Incorrect Measurement, Adverse Event Without Identified Device or Use Problem, Unintended Electrical Shock, and Dyspnea, which, while rare, were strongly associated with serious events. Co-occurrence network analysis revealed clinically interpretable community structure, including a heart failure decompensation cluster and a procedural complication cluster. CONCLUSIONS: The CardioMEMS HF System demonstrates a favorable post-market safety profile, with the overwhelming majority of MAUDE reports reflecting benign device malfunctions without clinical consequences. The majority of reported adverse events are attributable to the external home electronics unit rather than the implanted sensor, a distinction with important implications for clinical counseling and device management. Disproportionality analysis effectively separates high-volume, low-severity events from rare but clinically significant safety signals, providing a complementary perspective to clinical trial safety data.
LaRaja A, Chakraborty A, Talmor N
… +11 more, Graves C, Kozloff S, Major VJ, Shah B, Babaev A, Razzouk L, Rao SV, Attubato M, Feit F, Slater J, Smilowitz NR
BACKGROUND: Myocardial injury after percutaneous coronary intervention (PCI) is common and associated with adverse outcomes. Contemporary definitions of periprocedural myocardial infarction require biomarker elevation wi...BACKGROUND: Myocardial injury after percutaneous coronary intervention (PCI) is common and associated with adverse outcomes. Contemporary definitions of periprocedural myocardial infarction require biomarker elevation with or without ischemic electrocardiographic (ECG) findings. However, the incremental prognostic value of ECG beyond biomarker-defined injury alone remains uncertain. OBJECTIVES: To determine the incidence and independent prognostic value of ischemic ECG changes after elective PCI. METHODS: Consecutive adults age ≥ 18 years undergoing elective PCI at NYU Langone Health between 2011 and 2020 were included. Creatine kinase-myocardial band (CKMB) concentrations were measured at 1 and 3 h post-PCI. Among patients with myocardial injury, baseline and post-PCI ECGs (within 24 h) were reviewed to identify development of ischemic ECG changes (ST segment abnormalities, T wave abnormalities, and Q waves). Relationships between ischemic ECG findings and mortality were evaluated in Cox proportional hazards models adjusted for age, sex, and assay-normalized CKMB. RESULTS: Among 10,735 patients, 1741 (16.2%) developed post-PCI myocardial injury. New ischemic ECG changes occurred in 18.4% of patients with myocardial injury and increased stepwise with higher concentrations of CKMB. New T wave abnormalities were most common (11%), followed by ST depressions (4.9%), Q waves (3.0%), and ST elevations (1.5%). Over a median follow-up of 5.3 years, new ischemic ECG changes were not independently associated with increased mortality among patients with myocardial injury (aHR 1.27, 95% CI 0.82-1.96). CONCLUSIONS: Among patients with myocardial injury after elective PCI, new ischemic ECG changes were uncommon and did not confer independent prognostic value for long-term mortality.
Arow Z, Iwata J, Masumoto A
… +7 more, Millin A, Aker A, Vaknin-Assa H, Assali A, De Biase C, Dumonteil N, Tchetche D
Cardiovasc Revasc Med
· 2026 Jun · PMID 42399160
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BACKGROUND: Frailty is common among TAVR candidates. While guidelines recommend formal geriatric assessment for risk stratification, frailty is often evaluated in daily practice using physician judgment - "eyeball test"....BACKGROUND: Frailty is common among TAVR candidates. While guidelines recommend formal geriatric assessment for risk stratification, frailty is often evaluated in daily practice using physician judgment - "eyeball test". This study compared outcomes of frail versus non-frail patients undergoing TAVR using frailty classification based on eyeballing or formal geriatric assessment. METHODS: This study included all patients undergoing TAVR for severe aortic stenosis (AS) with balloon-expandable or self-expandable valves between 2012 and 2024. Frailty was assessed in two cohorts: by physician clinical judgment (the "eyeball" cohort) or by formal comprehensive geriatric assessment, which was reserved for cases deemed uncertain by the treating clinician. The primary endpoint was 1-year all-cause mortality. RESULTS: A total of 6343 patients were included in the study. Frailty was assessed by eyeballing in 4603 patients and by comprehensive geriatric assessment in 1740 patients. In the eyeball assessment cohort, frail patients exhibited significantly higher rates of in-hospital mortality (2.1% vs. 1.0%, p = 0.006) and 1-year mortality (8.1% vs. 6.3%, p = 0.024). In the formal geriatric assessment cohort, frail patients demonstrated a numerically higher 1-year mortality rate compared with non-frail patients (7.3% vs. 5.3%); however, this difference did not reach statistical significance (p = 0.160). In both cohorts, there were no significant differences in the composite safety endpoint, PPM implantation, or moderate or greater PVL. CONCLUSION: Frailty assessed by routine clinical "eyeballing" provided prognostic stratification after TAVR. A pragmatic two-step strategy - routine eyeballing with comprehensive geriatric assessment reserved for uncertain cases, may represent an efficient approach for frailty evaluation in contemporary TAVR practice.
Thakkar HV, Besis G, McCormick L
… +6 more, Gooley R, Chew D, Michail M, Nerlekar N, Ko B, Brown AJ
Cardiovasc Revasc Med
· 2026 Jun · PMID 42392909
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BACKGROUND AND AIMS: Peripheral arterial disease (PAD) and coronary artery disease (CAD) are both clinical manifestations of atherosclerosis, sharing pathobiological features with aortic stenosis (AS). Pre-transcatheter...BACKGROUND AND AIMS: Peripheral arterial disease (PAD) and coronary artery disease (CAD) are both clinical manifestations of atherosclerosis, sharing pathobiological features with aortic stenosis (AS). Pre-transcatheter aortic valve replacement (TAVR) planning routinely includes CT assessment of aorto-iliac and common femoral arterial disease. The aim was to assess the feasibility and accuracy of a novel PAD scoring system (Hostile score) to exclude obstructive CAD pre-TAVR. METHODS: Peripheral CTs of patients pre-TAVR, between 2019 and 2023, were retrospectively analysed and Hostile score calculated (low score ≤ 8.5, high score > 8.5). Obstructive CAD was defined as diameter stenosis ≥50% on invasive angiography. Feasibility and reproducibility of Hostile score was assessed. ROC analysis was performed to assess the accuracy of Hostile score to exclude obstructive CAD. RESULTS: 350 patients included (age 82 ± 7.2 yrs); 78% hypertension; 29% diabetes, 59% CKD and obstructive CAD present in 32.6%. Median Hostile score was 5 (IQR 2-8.9) with a median analysis time of 2.14 min (IQR 1.68-4.40). There was excellent intra-observer correlation (r = 0.91, 95%CI 0.84, 0.96) and a good interobserver correlation (r = 0.84, 95% CI 0.72, 0.91). Sensitivity, specificity, positive and negative predictive value of Hostile score to exclude obstructive CAD was 91.1%, 58.8%, 82.1% and 76.1%, respectively, with a diagnostic accuracy of 80.6% (AUC 0.82). Patients with high Hostile score had increased risk of all-cause mortality (OR 2.13, 95%CI 1.13, 4.02, p = 0.02). CONCLUSION: Hostile score has a high sensitivity and accuracy for excluding obstructive CAD in patients with severe AS and was associated with a higher all-cause mortality. Incorporating Hostile score as a screening tool on TAVR-CT may potentially reduce the requirement for invasive angiography.
Jurin I, Pavlov M, Manola Š
… +4 more, Poljak TBD, Krčmar T, Rudež I, Hadžibegović I
Cardiovasc Revasc Med
· 2026 Jun · PMID 42386402
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BACKGROUND: Lipoprotein(a) [Lp(a)] is an inherited lipid-related risk factor that may be overlooked in invasive coronary practice. We assessed the yield of Lp(a) testing in patients undergoing coronary angiography and it...BACKGROUND: Lipoprotein(a) [Lp(a)] is an inherited lipid-related risk factor that may be overlooked in invasive coronary practice. We assessed the yield of Lp(a) testing in patients undergoing coronary angiography and its association with anatomic coronary disease burden. METHODS: We performed a retrospective registry analysis of consecutive patients undergoing invasive coronary angiography between 15 June 2024 and 1 January 2026. Patients with available Lp(a) measurement were included. We assessed clinically relevant Lp(a) thresholds, reconstructed phase 3 trial-like frameworks for emerging Lp(a)-lowering therapies, and evaluated the association between Lp(a) ≥149 nmol/L and an anatomic complex coronary artery disease endpoint defined as SYNTAX score ≥23, chronic total occlusion, or left main disease. Index revascularization was excluded from this composite. RESULTS: Among 2379 unique patients, 2230 had available Lp(a) measurement. Men accounted for 1508 (67.6%) and women for 722 (32.4%). The cohort was overwhelmingly White European, although race/ethnicity was not systematically recorded and exact proportions were unavailable. Lp(a) was ≥125, ≥149, ≥175 and ≥200 nmol/L in 473 (21.2%), 413 (18.5%), 330 (14.8%) and 255 (11.4%) patients, respectively. After conservative renal exclusion, 264 patients (11.8%) remained potential candidates for at least one major phase 3 trial-like framework. Lp(a) ≥149 nmol/L was associated with anatomic complex CAD (adjusted odds ratio 1.50, 95% confidence interval 1.16-1.94; p = 0.002). CONCLUSIONS: In this male-predominant registry, Lp(a) elevation was common and identified a subgroup with trial-like screening relevance and greater anatomic CAD burden. Cross-sectional findings do not establish improved management or outcomes; generalizability by sex, age and ancestry requires prospective validation.
Moore X, Chan K, Ho SM
… +4 more, Basra S, Smalling R, Kar B, Dhoble A
Cardiovasc Revasc Med
· 2026 Jun · PMID 42379973
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BACKGROUND: Sex-related disparities after transcatheter aortic valve replacement (TAVR) have been described in tricuspid aortic stenosis, but long-term data in bicuspid aortic valve (BAV) stenosis remain limited. AIMS: T...BACKGROUND: Sex-related disparities after transcatheter aortic valve replacement (TAVR) have been described in tricuspid aortic stenosis, but long-term data in bicuspid aortic valve (BAV) stenosis remain limited. AIMS: To evaluate sex-based differences in long-term mortality and predictors of outcomes after TAVR in patients with BAV stenosis. METHODS: We retrospectively analyzed 327 patients with BAV stenosis (183 men, 144 women) who underwent TAVR from 2014 to 2025. Baseline, anatomic, procedural, and clinical outcomes were compared by sex. Cox models evaluated predictors of all-cause mortality and exploratory sex interactions. RESULTS: Over a median follow-up of 4.5 years by reverse Kaplan-Meier analysis, 93 deaths occurred (57 men, 36 women). Men had more coronary artery disease and greater aortic valve calcium burden than women (median 3519 vs 1815 AU; p < 0.001). Long-term mortality did not differ significantly by sex, although a nonsignificant late trend toward worse survival was observed in men (31.1% vs 25.0%; log-rank p = 0.095). Older age independently predicted mortality, while higher STS score and prior CABG demonstrated borderline associations. Exploratory interaction analyses identified sex interactions for eGFR (HR 0.965, 95% CI 0.944-0.987; p = 0.002) and diabetes (HR 0.217, 95% CI 0.076-0.620; p = 0.004). Higher eGFR was associated with lower mortality among women, whereas diabetes was associated with mortality among men. CONCLUSIONS: Long-term mortality after TAVR for BAV stenosis did not differ significantly by sex. Exploratory findings suggest selected clinical comorbidities may be more informative than the anatomic parameters evaluated in this cohort.
Garg K, Bhanushali V, Gautam N
… +12 more, Sawalha K, Rana A, Agrawal A, Spraggins RF, Bruich L, Alhwarat B, Almasri M, Saucedo JF, AbuHalimeh A, Tayal B, Rahman F, Al'Aref SJ
Cardiovasc Revasc Med
· 2026 Jun · PMID 42364947
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Acute coronary syndrome (ACS) remains a leading cause of emergency department presentations, yet triage based on the ST-elevation myocardial infarction (STEMI)/non-ST-elevation myocardial infarction (NSTEMI) paradigm mis...Acute coronary syndrome (ACS) remains a leading cause of emergency department presentations, yet triage based on the ST-elevation myocardial infarction (STEMI)/non-ST-elevation myocardial infarction (NSTEMI) paradigm misses approximately 25-34% of acute coronary occlusion myocardial infarction (OMI). Early artificial intelligence-electrocardiography (AI-ECG) models showed retrospective promise for detecting ischemic ECG patterns but lacked prospective validation. This review synthesizes emerging multicenter registry, prospective cohort, and pathway trial evidence for AI-ECG in ACS triage, including the Queen of Hearts registry, ROMIAE, and DIFOCCULT-3 studies. It is essential to distinguish two separate clinical tasks: (1) detecting OMI for emergent catheterization laboratory activation, and (2) ruling out acute myocardial infarction (MI), which requires serial high-sensitivity troponin and cannot be achieved by ECG alone. Contemporary findings suggest AI-ECG significantly improves OMI detection sensitivity (92% vs. 71% for standard care) and reduces false-positive catheterization laboratory activations by up to 91% among biomarker-negative patients. For acute MI rule-out, AI-ECG shows promise as an adjunct to troponin-based strategies, with a negative predictive value of approximately 99% when combined with high-sensitivity troponin and clinical risk scores. We propose a 'Second Opinion' framework in which AI augments physician judgment as a clinical decision support tool. Key implementation challenges include algorithmic bias, alert fatigue, documentation, and the risk of widening the digital divide. AI-ECG represents a shift toward a physiologically driven OMI vs. non-occlusive myocardial infarction (NOMI) diagnostic framework.
Rmilah AA, Asad T, Awashra A
… +8 more, Hmeedan A, Khatib L, Shubietah A, Alzu'bi H, Al-Muhaisen R, Alzeghoul A, Lackey A, Arias J
Cardiovasc Revasc Med
· 2026 Jun · PMID 42350254
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BACKGROUND: Transcatheter edge-to-edge repair (TEER) has expanded treatment options for severe tricuspid regurgitation (TR), but outcomes remain heterogeneous and patient selection remains challenging. TRI-SCORE, a disea...BACKGROUND: Transcatheter edge-to-edge repair (TEER) has expanded treatment options for severe tricuspid regurgitation (TR), but outcomes remain heterogeneous and patient selection remains challenging. TRI-SCORE, a disease-specific score developed for isolated tricuspid valve surgery, may help identify high-risk patients before tricuspid TEER. We performed a systematic review and meta-analysis evaluating the association between baseline TRI-SCORE and outcomes after tricuspid TEER. METHODS: MEDLINE and Embase were searched from inception through January 2026. Eligible studies included adults undergoing tricuspid TEER and reported outcomes according to baseline TRI-SCORE category, most commonly ≥6 versus <6. Random-effects models were used to calculate pooled risk ratios (RRs) with 95% confidence intervals (CIs). RESULTS: Five observational studies including 2074 patients were included. Higher TRI-SCORE was associated with greater all-cause mortality at in-hospital/30-day (RR, 3.17; 95% CI, 1.71-5.89), 3-month (RR, 4.03; 95% CI, 2.62-6.17), 6-month (RR, 2.97; 95% CI, 2.05-4.32), and 1-year follow-up (RR, 2.62; 95% CI, 1.88-3.66). Higher TRI-SCORE was also associated with lower likelihood of residual TR grade ≤2 in-hospital (RR, 0.88; 95% CI, 0.81-0.97), at 30 days (RR, 0.86; 95% CI, 0.76-0.97), and at 3 months (RR, 0.75; 95% CI, 0.58-0.98). The composite of death and/or heart failure rehospitalization was more frequent in high-risk patients. CONCLUSIONS: In patients undergoing tricuspid TEER, high baseline TRI-SCORE identifies advanced clinical risk associated with excess mortality, less frequent TR reduction, and more adverse events. TRI-SCORE may support interventional heart-team evaluation but should complement anatomy, right ventricular function, frailty, and hemodynamic assessment.
Makita T, Omori H, Miyazaki Y
… +4 more, Iwama M, Morishita K, Umeda Y, Noda T
Cardiovasc Revasc Med
· 2026 Jun · PMID 42350253
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BACKGROUND: FFRangio, which derives FFR from coronary angiography, has been reported to exhibit high diagnostic concordance with invasive FFR, rendering it an appealing diagnostic tool. However, its diagnostic performanc...BACKGROUND: FFRangio, which derives FFR from coronary angiography, has been reported to exhibit high diagnostic concordance with invasive FFR, rendering it an appealing diagnostic tool. However, its diagnostic performance in the presence of coronary microvascular dysfunction (CMD) remains unexamined. Consequently, we conducted a study to assess the diagnostic performance of FFRangio in patients with CMD. METHODS: The study included 111 vessels (94 patients) in which FFRangio, invasive FFR, and the index of microcirculatory resistance (IMR) were measured. CMD status was categorized into two groups: low IMR (IMR < 25) and high IMR (IMR ≥ 25). The impact of CMD on the diagnostic performance of FFRangio was assessed with invasive FFR as the reference standard. RESULTS: The diagnostic performance (area under the curve: AUC) of FFRangio was high in the overall cohort (AUC: 0.92 [95% CI: 0.87 to 0.98]). However, when assessed according to microcirculatory status, the AUC of FFRangio was significantly lower in the high-IMR group compared to the low-IMR group (low-IMR group 0.98 [95% CI: 0.94 to 1.00] vs. high-IMR group 0.83 [95% CI: 0.69 to 0.96]; p = 0.04). The correlation between invasive FFR and FFRangio was lower in the high-IMR group than in the low-IMR group (r = 0.60 vs. 0.79). The agreement between FFRangio and invasive FFR was -0.03 (limits of agreement: -0.14-0.08) in the low-IMR group and - 0.06 (limits of agreement: -0.22-0.09) in the high-IMR group. CONCLUSIONS: CMD may contribute to reduced diagnostic concordance between FFRangio and invasive FFR.
Galo J, Al-Qaraghuli A, Haberman D
… +10 more, Jena N, Abusnina W, Cellamare M, Offit M, Zhang C, Verma B, Rubio PM, Ben-Dor I, Waksman R, Rogers T
Cardiovasc Revasc Med
· 2026 Jun · PMID 42350252
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BACKGROUND: Stroke is a major adverse event following transfemoral transcatheter aortic valve replacement (TAVR), often attributed to embolization of debris from the aortic valve or aorta. This study evaluated the relati...BACKGROUND: Stroke is a major adverse event following transfemoral transcatheter aortic valve replacement (TAVR), often attributed to embolization of debris from the aortic valve or aorta. This study evaluated the relationship between severe aortic wall thrombus (AWT) on pre-TAVR imaging and peri-procedural stroke in a single-center cohort. METHODS: Patients with peri-procedural stroke after transfemoral TAVR (January 2013-December 2023) were compared with a randomly selected stroke-free control group. Severe AWT on baseline CT was assessed using a validated segmental scoring system. Associations with stroke were examined using Firth penalized logistic regression, with a pre-specified multivariable model adjusting for severe aortic root calcification, pre-TAVR albumin, recent heart failure, and valve type. RESULTS: Fifty-six patients with peri-procedural stroke (mean age 82 ± 8.6 years) and 92 controls (mean age 79 ± 9.8 years) were included. Strokes occurred a median of 1.5 days (interquartile range, 0-4 days) following TAVR. Severe AWT was present in 21.4% of stroke patients versus 3.3% of controls, corresponding to a univariable odds ratio (OR) of 7.18 (95% CI 2.28-29.16, p < 0.001). In the multivariable Firth model, severe AWT remained independently associated with stroke (OR 8.98, 95% CI 2.01-49.55, p = 0.004). AWT most frequently involved the descending thoracic (43%) and abdominal aorta (54%), and less commonly the ascending aorta (9-16%). CONCLUSION: Severe AWT on pre-TAVR CT was independently associated with peri-procedural stroke in this single-center analysis. Given the retrospective design and temporal differences between groups, these hypothesis-generating findings warrant prospective validation.
Szekely M, Lopez-Trevino MG, Gecse II
… +13 more, Kritya M, Kharsa C, Sarfaraz ZK, Aoun J, Reul RM, Quarti AG, Lawrie GM, Goel SS, Ramchandani M, Del Val FR, Kleiman NS, Reardon MJ, Atkins MD
Cardiovasc Revasc Med
· 2026 Jun · PMID 42315444
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OBJECTIVE: Indications for transcatheter aortic valve replacement (TAVR) are expanding into younger, lower-risk patients, and TAVR explants are increasing. We report our 10-year single-center experience and outcomes foll...OBJECTIVE: Indications for transcatheter aortic valve replacement (TAVR) are expanding into younger, lower-risk patients, and TAVR explants are increasing. We report our 10-year single-center experience and outcomes following TAVR explant. METHODS: All TAVR explants performed between January 2015 and September 2025 were retrospectively reviewed. Patients were stratified into early-explant (≤30 days from index TAVR) and late-explant (>30 days) groups. Late-explant patients were further categorized as lower-risk (SAVR after TAVR risk score ≤ 8) or high-risk (>8). The primary endpoint was operative mortality; secondary endpoints included observed-to-expected (O/E) mortality and midterm survival. RESULTS: Sixty-six TAVR explants were performed: 9 (13.6%) early and 57 (86.4%) late. Among late explants, 40 (70.2%) were lower-risk and 17 (29.8%) high-risk. Median time to explant in this cohort was 37.3 months (IQR:17.2-66.1). Indications were structural valve degeneration (33.3%), endocarditis (30%), valve thrombosis (6.1%), non-structural dysfunction (16.7%) and acute causes (13.6%). Within the late-explant cohort, only 13 patients (22.8%) had an isolated aortic valve replacement; most required concomitant procedures. Operative mortality was 22.2% for early and 15.8% for late explants. Among late cases, operative mortality was higher in the high-risk group (41.2% vs 5%, p = 0.002), with a substantially increased O/E mortality ratio (2.81 vs 1.40). Survival at 1, 2, and 3 years was 82.8%, 78.4%, and 65.8% in the lower-risk group versus 45.3% at all time points in the high-risk group. CONCLUSIONS: TAVR explantation carries operative mortality higher than anticipated, particularly in high-risk patients. A TAVR-first strategy in younger and lower-risk populations warrants careful consideration within a lifetime management framework.
Cardiovasc Revasc Med
· 2026 Jun · PMID 42315443
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INTRODUCTION: Surgical intervention for aortic regurgitation (AR) is often deferred for high-risk patients. Our study evaluated patient outcomes with non- or minimally calcified AR undergoing TAVR with self-expanding val...INTRODUCTION: Surgical intervention for aortic regurgitation (AR) is often deferred for high-risk patients. Our study evaluated patient outcomes with non- or minimally calcified AR undergoing TAVR with self-expanding valves, regardless of anatomical features, including those with LVAD support. METHODS: A retrospective observational cohort study was conducted at a single academic center from 01/01/2012 to 12/01/2024. Eligible patients were those with greater than moderate AR, high/inoperable surgical risk, aortic valve calcium score < 400. Primary outcomes were all-cause and cardiovascular (CV)-related mortality rates at 1 and 12 months. Secondary outcomes included rehospitalization rates, procedural complications, in-hospital events, and Valve Academic Research Consortium-3 (VARC) success rates at 1 month. RESULTS: 25 patients who underwent TAVR were included, 13 were female with mean age 67 ± 14 years. The majority (76%) of patients presented with severe AR with a mean aortic valve calcium score of 61.5 ± 109.2. No intraprocedural death or conversion to open surgery occurred. Only one all-cause mortality occurred within 30 days, with Kaplan-Meier survival rate of 96% and 84%, at 1 month and 12 months, respectively. Heart failure-related hospitalization occurred in less than 10% of patients at 12 months. Technical success rate was 80%, with ventricular device migration occurring in five patients (20%), two of which were on LVAD support. In those cases, a second balloon-expandable valve was implanted achieving ≤ mild AR. All patients achieved mild or less residual AR at 12 months. CONCLUSION: Off-label TAVR use with self-expanding valves for AR is achievable with favorable safety and efficacy in select patients with and without LVADs.
Cardiovasc Revasc Med
· 2026 Jun · PMID 42315442
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Fractional flow reserve (FFR) remains the most widely adopted invasive physiologic index for determining the functional significance of epicardial coronary artery disease (CAD). By applying a validated binary threshold f...Fractional flow reserve (FFR) remains the most widely adopted invasive physiologic index for determining the functional significance of epicardial coronary artery disease (CAD). By applying a validated binary threshold for myocardial ischemia, FFR guides clinical decision-making regarding the need for coronary revascularization. However, CAD is often heterogeneous, with varying patterns of focal and diffuse atherosclerotic involvement that are not fully captured by a single distal FFR value. Assessment of pressure changes along the vessel using hyperaemic pullback recordings provides additional pathophysiologic insight by depicting the spatial distribution of pressure loss as a pullback curve. Traditionally, interpretation of these curves has been largely visual and subjective, resulting in considerable interobserver variability and limited reproducibility. The pullback pressure gradient (PPG) index has emerged as a novel quantitative tool to overcome these limitations. By integrating the magnitude and longitudinal distribution of pressure gradients, PPG characterizes CAD patterns on a continuous scale from 0 to 1, where higher values indicate predominantly focal disease and lower values reflect diffuse disease. This review critically appraises the conceptual framework, clinical evidence, practical implications, and future directions of PPG in contemporary coronary physiology.
Suruagy-Motta RFO, Martins-Pedrosa R, Amaral Barros M
… +11 more, de Brito Pontes AB, Aguiar-Barros ABP, Bert de Mendonça MC, Souza-Carvalho JA, Barbosa GLV, Pileggi B, Souza MO, Cervone AC, Filho EM, Fernandes JR, Stone GW
Cardiovasc Revasc Med
· 2026 Jun · PMID 42265030
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INTRODUCTION: Mitral transcatheter edge-to-edge repair (M-TEER) has become a cornerstone for treating patients with mitral regurgitation (MR). However, the prognostic impact of baseline tricuspid regurgitation (TR) on ou...INTRODUCTION: Mitral transcatheter edge-to-edge repair (M-TEER) has become a cornerstone for treating patients with mitral regurgitation (MR). However, the prognostic impact of baseline tricuspid regurgitation (TR) on outcomes after M-TEER remains uncertain. This systematic review and meta-analysis evaluates the influence of baseline TR in patients undergoing M-TEER. METHODS: We searched PubMed, Embase, SCOPUS, Cochrane Library, and Web of Science through January 2026. Studies comparing outcomes in patients with none/mild TR versus moderate/severe TR after M-TEER were included. Data were synthesized using random-effects models. RESULTS: Eight observational studies involving 24,129 patients were included. Compared to patients with none/mild TR, those with baseline moderate/severe TR had a 2.05-fold higher risk of all-cause mortality (RR 2.05; 95% CI: 1.41-2.98) and an 82% higher risk of heart failure rehospitalization (RR 1.82; 95% CI: 1.22-2.73). Moderate/severe TR was also associated with a 5% lower likelihood of procedural success (RR 0.95; 95% CI: 0.94-0.97). Regarding echocardiographic outcomes, patients with baseline moderate/severe TR had a 12% lower probability of achieving none/mild residual MR (RR 0.88; 95% CI: 0.80-0.97) and a 20% higher risk of moderate residual MR (RR 1.20; 95% CI: 1.05-1.38), though the risk of severe residual MR did not differ significantly between groups. Baseline moderate/severe TR was associated with a 48% higher risk of NYHA class ≥ III at follow-up (RR 1.48; 95% CI: 1.27-1.73). Although statistically significant, the pooled differences in follow-up sPAP (MD: 0.25 mmHg) and LVEF (MD: -0.08%) were clinically negligible, while no significant differences were observed in TAPSE. CONCLUSIONS: Baseline moderate/severe TR is strongly associated with a worse prognosis and limited functional recovery following M-TEER. Further studies are warranted to determine whether simultaneous or staged TR interventions improve outcomes in patients undergoing M-TEER.
Sachdeva R, Towbin N, Mullinax B
… +2 more, Warnock R, Kumar G
Cardiovasc Revasc Med
· 2026 Jun · PMID 42252250
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BACKGROUND: Resting distal-to-aortic coronary pressure (Pd/Pa), resting full-cycle ratio (RFR), fractional flow reserve (FFR), coronary flow reserve (CFR), and index of microvascular resistance (IMR) are established tool...BACKGROUND: Resting distal-to-aortic coronary pressure (Pd/Pa), resting full-cycle ratio (RFR), fractional flow reserve (FFR), coronary flow reserve (CFR), and index of microvascular resistance (IMR) are established tools for assessing obstructive coronary artery disease but remain poorly characterized in chronic total occlusion (CTO). Evaluating immediate hemodynamic changes after CTO revascularization may serve as a marker of benefit from intervention. METHODS: We retrospectively analyzed hemodynamic data from patients undergoing CTO percutaneous coronary intervention (PCI) at a Veterans Affairs hospital between January 2024 and July 2025. Measurements (Pd/Pa, RFR, FFR, CFR, IMR) were obtained after successful CTO crossing and compared pre- and post-PCI using the CoroFlow system (Abbott Vascular, Lake County, IL). Demographics, procedural characteristics, and clinical outcomes-including death, myocardial infarction (MI), target lesion revascularization (TLR), and angina improvement-were recorded. RESULTS: Twenty patients were included. CTO locations were the left anterior descending (35%), right coronary artery (35%), and left circumflex (25%). Mean lesion length was 47.6 ± 23.1 mm, with a median J-CTO score of 2 ± 1. Pre-PCI Pd/Pa (0.60 ± 0.14), RFR (0.51 ± 0.18), and FFR (0.46 ± 0.10) improved significantly post-PCI to 0.96 ± 0.04, 0.95 ± 0.04, and 0.87 ± 0.08, respectively. Post-PCI CFR was 3.30 ± 2.74 and IMR 23.9 ± 33.5. No peri-procedural complications occurred; 5% experienced MI and 10% required TLR at 7.2 ± 3.5 months. CONCLUSION: There was marked improvement in hemodynamic indices after PCI of the evaluated CTO lesions, and microvascular function was normalized immediately following revascularization.
Khraisat O, Messer T, Aljabali A
… +8 more, Alqaseer A, Ismail W, Samardali H, Alkhawaldeh E, Alahmad A, Patel D, Schwarcz A, Hastings RS
Cardiovasc Revasc Med
· 2026 Jun · PMID 42250996
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BACKGROUND: Stroke remains a significant complication after transcatheter aortic valve replacement (TAVR), and embolic debris generated during the procedure is a major contributor. The Sentinel Cerebral Protection System...BACKGROUND: Stroke remains a significant complication after transcatheter aortic valve replacement (TAVR), and embolic debris generated during the procedure is a major contributor. The Sentinel Cerebral Protection System is designed to reduce periprocedural stroke and stroke-related complications, but real-world data on device-related complications remain limited. METHODS: We performed a retrospective descriptive analysis of post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database (September 2022-January 2026) to assess Sentinel-related adverse events, including deaths, injuries, and device malfunctions. Reports were categorized by event type, and findings were summarized as counts and percentages. RESULTS: A total of 340 reports were included. Malfunctions were most frequent (77.9%), followed by injuries (20.6%) and deaths (1.5%). Stroke and associated cerebrovascular events accounted for 48 of patient-related adverse events. Common device issues included difficulty in removal in 147 cases, breakage in 64 cases, and positioning problems in 57 cases. Rare complications such as detachment, contamination, and mechanical failure were also noted. CONCLUSIONS: This MAUDE database analysis found that reported Sentinel-related events were predominantly technical in nature, although clinically important adverse events were also identified. These findings provide real-world insights into device performance, highlight areas for procedural and design improvement, and underscore the importance of ongoing post-market surveillance.