Lalani C, Secemsky E, Song Y
… +12 more, Dong H, Kirtane AJ, Neupane S, Krishnaswamy A, Price MJ, Davies R, Frizzell JD, Kearney KE, Safirstein J, Ali ZA, Cavalcante R, Yeh RW
Circ Cardiovasc Interv
· 2026 May · PMID 42117274
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BACKGROUND: AGENT is the only coronary drug-coated balloon (DCB) approved for treatment of in-stent restenosis (ISR) to date. In this study, we describe trends in DCB use and compare characteristics and in-hospital outco...BACKGROUND: AGENT is the only coronary drug-coated balloon (DCB) approved for treatment of in-stent restenosis (ISR) to date. In this study, we describe trends in DCB use and compare characteristics and in-hospital outcomes between patients who received DCB versus alternative treatments. METHODS: We included patients in the American College of Cardiology National Cardiovascular Disease Registry CathPCI Registry who underwent percutaneous coronary intervention between April 2024 and June 2025 and received DCB, drug-eluting stent (DES), or plain old balloon angioplasty. Treatment groups were compared using standard mean differences. RESULTS: Between April 2024 and June 2025, 14 946 DCBs were used in 12 337 patients across 704 CathPCI Registry sites. The monthly rate of DCB use for ISR percutaneous coronary intervention grew from <1% to 17.5% during the study period. Of 96 452 ISR procedures performed overall, 9269 (9.61%) involved the use of DCB. DCB procedures were more likely to involve the use of specialty balloons (DCB 45.3% versus DES 17.5% versus plain old balloon angioplasty 28.3%), intravascular imaging (DCB 54.5% versus DES 35.1% versus plain old balloon angioplasty 30.9%), and atherectomy (DCB 14.9% versus DES 6.0% versus plain old balloon angioplasty 7.3%). Among patients treated with DCB, 0.4% experienced myocardial infarction, 0.7% developed cardiogenic shock, 0.2% had an ischemic stroke, and 0.9% died. DCB was separately used in 3459 of 810 483 (0.43%) non-ISR percutaneous coronary interventions. Unadjusted rates of in-hospital adverse outcomes after ISR and non-ISR DCB use were like those for DES (standard mean difference <10%). CONCLUSIONS: Real-world DCB use is increasing rapidly in the United States, driven by use in ISR lesions but also with growth among non-ISR lesions.
Fabris T, Arturi F, Buono A
… +60 more, de Biase C, Bellamoli M, Zito A, Mangieri A, Montarello N, Costa G, Alfadhel M, Koren O, Fezzi S, Bellini B, Massussi M, Scotti A, Bai L, Costa G, Mazzapicchi A, Giacomin E, Gorla R, Hug K, Briguori C, Bettari L, Messina A, Boiago M, Renker M, Garcia Gomez M, Napodano M, Fraccaro C, Nai Fovino L, Masiero G, Cardaioli F, Putortì F, Panza A, De Rosa ML, Trani C, Laterra G, Latini A, Pellegrini D, Ielasi A, Orbach A, Landes U, Rheude T, Testa L, Amat Santos I, Saia F, Favero L, Cernetti C, Chen M, Adamo M, Latib A, Petronio AS, Montorfano M, Makkar RR, Burzotta F, Barbanti M, Blackman DJ, Mylotte D, De Backer O, Tchètchè D, Maffeo D, Kim WK, Tarantini G
BACKGROUND: Evidence regarding prosthesis-patient mismatch (PPM), measured (mPPM), and predicted (pPPM), after transcatheter aortic valve replacement in bicuspid aortic valve stenosis remains limited. This study sought t...BACKGROUND: Evidence regarding prosthesis-patient mismatch (PPM), measured (mPPM), and predicted (pPPM), after transcatheter aortic valve replacement in bicuspid aortic valve stenosis remains limited. This study sought to evaluate the incidence, predictors, and prognostic implications of mPPM and pPPM in patients with Sievers type 1 bicuspid aortic valve undergoing transcatheter aortic valve replacement. METHODS: The AD-HOC registry is a retrospective, multicenter study including 781 patients with severe aortic stenosis and bicuspid aortic valve treated with transcatheter aortic valve replacement between 2016 and 2023 across 24 centers. PPM was defined according to Valve Academic Research Consortium-3 criteria. The primary outcome was all-cause mortality. RESULTS: Moderate-to-severe mPPM was more frequent than pPPM (22% versus 8%; <0.001). Balloon-expandable valves were independently associated with both mPPM and pPPM, while smaller valve size and supra-annular sizing predicted only pPPM. During a mean follow-up of 621±470 days, neither mPPM nor pPPM was associated with mortality in the overall cohort. Among patients with a small annulus (≤430 mm; n=145), pPPM occurrence was significantly higher (19% versus 5.5%; <0.001) and was associated with increased all-cause mortality, but not with cardiovascular mortality. CONCLUSIONS: In patients with Sievers type 1 bicuspid aortic valve undergoing transcatheter aortic valve replacement, pPPM occurred less frequently than mPPM and was predominantly driven by anatomic characteristics and sizing strategies. Although pPPM was associated with increased all-cause mortality among patients with small annuli, this association did not extend to cardiovascular mortality and should be considered hypothesis-generating. Further prospective investigations are warranted to better delineate the impact of anatomic constraints on clinical outcomes in this anatomically challenging subset.
Rudolph F, Goncharov A, Narang A
… +13 more, Körber ML, Puthumana JJ, Malaisrie SC, Meng Z, Baldrigde A, Rudolph TK, Friedrichs KP, Pfister R, Thomas JD, Potratz M, Rudolph V, Davidson CJ, Gerçek M
BACKGROUND: Observational registries have shown improved survival among patients with severe or greater tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve repair (TTVr) compared with conservative manag...BACKGROUND: Observational registries have shown improved survival among patients with severe or greater tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve repair (TTVr) compared with conservative management. However, it remains unclear whether this survival benefit persists when specifically comparing patients undergoing TTVr with those who screen failed. METHODS: We conducted a retrospective analysis of 547 patients from the TriSelect registry evaluated for TTVr-either transcatheter tricuspid valve edge-to-edge repair or direct transcatheter tricuspid valve annuloplasty at 3 tertiary centers in the United States and Germany between 2016 and 2021. The end point of 1-year survival was stratified by treatment group (TTVr versus screen fail) and procedural success (residual TR ≤ moderate versus > moderate). RESULTS: Of the 547 patients, 219 (41.9%) screen failed and 318 (58.1%) underwent TTVr (transcatheter tricuspid valve edge-to-edge repair, 61.6%; transcatheter tricuspid valve annuloplasty, 38.4%). Among treated patients, 224 (70.4%) achieved residual TR ≤ moderate. Unadjusted Kaplan-Meier-derived 1-year survival was significantly higher in patients who underwent TTVr compared with screen-fail patients (82.5% versus 68.4%, log-rank <0.001). In multivariable Cox proportional hazards analysis, treatment with TTVr was independently associated with lower 1-year mortality (hazard ratio, 0.40 [95% CI, 0.18-0.86]; =0.020). Among treated patients, survival was significantly higher in those with residual TR ≤ moderate versus those with greater than moderate residual TR (88.0% versus 69.2%, unadjusted log-rank =0.005). Notably, in patients with residual TR > moderate, there was no survival benefit compared with screen-fail patients (unadjusted log-rank =0.74). CONCLUSIONS: In this registry-based analysis, TTVr was associated with improved 1-year survival compared with screen-fail patients, but only when TR was reduced to moderate or less. These findings highlight the critical importance of achieving procedural success with a TTVr along with early referral and transcatheter tricuspid valve intervention device selection.
Qureshi AM, Justino H, Owada C
… +8 more, Numan M, Ebeid M, Forbes TJ, Nykanen D, Kobayashi D, Kolles J, Gutfinger D, Balzer D
Circ Cardiovasc Interv
· 2026 Jun · PMID 42083863
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BACKGROUND: The Amplatzer Muscular Ventricular Septal Defect (VSD) Occluder (Abbott Structural Heart, Plymouth, MN) was approved by the US Food and Drug Administration in 2007. As a condition of approval, a postapproval...BACKGROUND: The Amplatzer Muscular Ventricular Septal Defect (VSD) Occluder (Abbott Structural Heart, Plymouth, MN) was approved by the US Food and Drug Administration in 2007. As a condition of approval, a postapproval study was required to further evaluate its safety and effectiveness. This study reports the clinical outcomes from the postapproval study over 5 years of follow-up. METHODS: Patients with complex congenital muscular VSDs at high risk for surgical closure were enrolled between May 2008 and February 2020 in the United States and Canada. The primary effectiveness end points were technical implant success, acute procedure shunt-closure success, and 1-year shunt-closure success. The primary safety end point was the proportion of patients with any serious adverse event within 12 months of the procedure. RESULTS: A total of 92 patients (median age, 2 years; 50 females) were enrolled in the study. Technical implant success was achieved in 93.8% of patients, and acute shunt-closure success was achieved in 78.0%. Successful shunt closure at 1-year was 94.4% and increased to >98% between 2 and 5 years. Within 12 months of the procedure, all-cause serious adverse events occurred in 47 of the 90 (52.2%) patients which included 7 device-related and 23 procedure-related serious adverse events. Between 1 and 5 years, there was 1 additional device- and procedure-related serious adverse event. CONCLUSIONS: This postapproval study demonstrates that transcatheter muscular VSD closure with the Amplatzer Muscular VSD Occluder is a safe and effective therapy for the treatment of complex congenital muscular VSDs in patients who are at high-risk for surgical closure. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT00647387.
BACKGROUND: An early feasibility study was conducted to evaluate the performance of a low-profile, microaxial percutaneous ventricular assist device (pVAD; Supira Medical, Los Gatos, CA) capable of up to 5.5 L/min flow t...BACKGROUND: An early feasibility study was conducted to evaluate the performance of a low-profile, microaxial percutaneous ventricular assist device (pVAD; Supira Medical, Los Gatos, CA) capable of up to 5.5 L/min flow to provide hemodynamic support in high-risk percutaneous coronary intervention. METHODS: A prospective, single-arm feasibility study using the Supira pVAD in high-risk percutaneous coronary intervention was performed at 4 centers in the United States. The primary feasibility end point was defined as successful initiation and maintenance of hemodynamic support without sustained hypotension or need for alternative mechanical circulatory support. The primary safety end point was the occurrence of major device-related adverse events attributed to the study device or procedure from the time of device insertion to removal. RESULTS: Fifteen patients underwent elective high-risk percutaneous coronary intervention with hemodynamic support using the Supira pVAD system. Multivessel percutaneous coronary intervention was performed in 80% of cases, including unprotected left main revascularization (67%) and atherectomy and intravascular lithotripsy (60%). Technical and procedural success rates were 93.3% and 86.7%, respectively. The primary feasibility end point was achieved in all 15 patients (100%). The primary safety end point occurred in 1 patient (6.7%). By 90 days, there were 2 deaths unrelated to the study device. There were no bleeding events, vascular/limb complications requiring intervention, cardiac structural/valve injury, or stroke attributed to the study device. CONCLUSIONS: As an early feasibility study, treatment with the Supira pVAD demonstrated favorable performance and device-related safety. These findings add to existing experience with the Supira pVAD to support a forthcoming pivotal trial in high-risk percutaneous coronary intervention. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT06087575.
BACKGROUND: Although ambulatory ECG (AECG) monitoring has been assessed after transcatheter aortic valve replacement (TAVR), its impact on life-threatening cardiovascular events remains unclear. This study aimed to evalu...BACKGROUND: Although ambulatory ECG (AECG) monitoring has been assessed after transcatheter aortic valve replacement (TAVR), its impact on life-threatening cardiovascular events remains unclear. This study aimed to evaluate whether systematic AECG monitoring after TAVR reduces life-threatening cardiovascular events during the first year of follow-up. METHODS: The study included 1217 consecutive patients who underwent TAVR and were discharged without a permanent pacemaker. Of these, 211 consecutive patients received systematic 14-day AECG monitoring at discharge as part of the RECORD registry. The remaining 1006 patients who underwent TAVR within the 3 years before and after the registry period without systematic AECG monitoring constituted the control group. The primary end point was a composite of sudden cardiac death, syncope/presyncope due to symptomatic arrhythmias, or stroke at 1-year. RESULTS: Baseline and procedural characteristics were similar between groups, except for a higher use of self-expandable valves in the control group (=0.005). Systematic AECG monitoring was associated with a lower incidence of the primary end point (1.9% versus 6.6%; adjusted hazard ratio, 0.27 [0.10-0.74]; =0.011), mainly driven by a lower rate of sudden death or arrhythmic syncope/presyncope (0.9% versus 4.0%; adjusted hazard ratio, 0.22 [0.05-0.89]; =0.034). All sudden death cases occurred in the control group, at a median of 96 (33-235) days after TAVR. New-onset atrial fibrillation was diagnosed in 8.9% of the systematic AECG patients (versus 1.8% in the control group; adjusted hazard ratio, 5.31 [2.47-11.38]; <0.001), leading to new oral anticoagulation in 71.4% of cases. Stroke and permanent pacemaker implantation rates at 1 year were similar between groups, although permanent pacemaker implantation occurred earlier in the AECG group (25 versus 104 days; <0.001). CONCLUSIONS: Systematic AECG monitoring after TAVR enables earlier detection of severe arrhythmias and is associated with fewer life-threatening cardiovascular events within 1 year. These findings support the need for a randomized trial. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT04298593.
BACKGROUND: Drug-coated balloons (DCBs) are increasingly adopted in percutaneous coronary intervention. Bail-out drug-eluting stent (DES) implantation due to suboptimal immediate results after DCB angioplasty is not infr...BACKGROUND: Drug-coated balloons (DCBs) are increasingly adopted in percutaneous coronary intervention. Bail-out drug-eluting stent (DES) implantation due to suboptimal immediate results after DCB angioplasty is not infrequent, and the clinical outcomes of percutaneous coronary intervention with DCB angioplasty followed by bail-out DES implantation remain unexplored. The aim of this study was to evaluate the safety of bail-out DES implantation following DCB angioplasty in percutaneous coronary intervention. METHODS: The BAILOUT registry included consecutive patients undergoing bail-out DES implantation after DCB angioplasty at 17 European centers between 2011 and 2024. The primary end point was target lesion failure (TLF) at 1 year, defined as the composite of target lesion revascularization, target vessel myocardial infarction, and cardiac death. The TLF rate was compared with a performance goal of 7.0% for an upfront DES-only strategy, derived from a meta-analysis of contemporary randomized controlled trials. RESULTS: A total of 733 patients were included, accounting for 5.5% of all DCB-based percutaneous coronary interventions. At 1 year, the cumulative TLF incidence in the overall population was 7.0% (95% CI, 5.2%-9.3%), which was comparable to the performance goal (=0.916). This was mainly driven by target lesion revascularization (4.1%), while cardiac death and target vessel myocardial infarction occurred both in 1.9% of patients. The incidence of stent thrombosis was 0.6%. Independent predictors of 1-year TLF included lesion length (hazard ratio, 1.02 per mm increase [95% CI, 1.01-1.03]; <0.001), moderate-to-severe calcification (hazard ratio, 2.82 [95% CI, 1.48-5.40]; =0.002), and the use of paclitaxel- versus sirolimus-coated balloons (hazard ratio, 1.99 [95% CI, 1.01-4.05]; =0.048). CONCLUSIONS: In cases of suboptimal angiographic results after DCB angioplasty, bail-out DES implantation is safe, with no increased risk of TLF at 1 year compared with the expected performance goal for an upfront DES-only strategy.
BACKGROUND: The ideal timing for complete revascularization (CR) in patients with ST-segment-elevation myocardial infarction and multivessel disease is uncertain. This meta-analysis examined outcomes of immediate CR (ICR...BACKGROUND: The ideal timing for complete revascularization (CR) in patients with ST-segment-elevation myocardial infarction and multivessel disease is uncertain. This meta-analysis examined outcomes of immediate CR (ICR) versus staged CR (SCR). METHODS: Four databases were searched for randomized controlled trials that compared ICR and SCR in ST-segment-elevation myocardial infarction and multivessel disease. The primary end points of interest were short-term and long-term all-cause mortality. Outcomes are presented as risk ratios for short-term outcomes and incidence rate ratios for long-term outcomes with 95% CIs. RESULTS: The analysis included 9 randomized controlled trials in which 4213 patients were enrolled. Short-term all-cause mortality occurred in 2.0% of patients after ICR compared with 1.2% of patients after SCR (risk ratio, 1.66 [95% CI, 0.99-2.78], =0.053; =0%). Short-term cardiac death was increased after ICR (risk ratio, 2.19 [95% CI, 1.08-4.44], =0.03; =0%). At a median 1-year follow-up, all-cause mortality occurred in 4.7% of patients after ICR compared with 3.5% of patients after SCR (incidence rate ratio, 1.40 [95% CI, 0.97-2.03], =0.07; =0%). No significant differences were identified between the ICR and SCR strategies at either short-term or long-term follow-up for other outcomes, including myocardial infarction, repeat revascularization, stent thrombosis, stroke, major bleeding, and the composite of major adverse cardiac or cerebrovascular events. CONCLUSIONS: In hemodynamically stable patients with ST-segment-elevation myocardial infarction and multivessel disease, an ICR strategy may increase short-term cardiac death compared with SCR, and the possibility of increased early and late all-cause mortality cannot be excluded. Despite some uncertainty, these results currently favor a staged CR strategy for most patients with ST-segment-elevation myocardial infarction and multivessel disease. REGISTRATION:URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD420251163719.
Trimaille A, Avvedimento M, Gleeton G
… +13 more, Del Portillo JH, Giuliani C, Vidal-Calés P, Real C, Paradis JM, Mohammadi S, Poulin A, Beaupré F, Porterie J, Kalavrouziotis D, Dumont E, Pelletier-Beaumont E, Rodés-Cabau J
BACKGROUND: The clinical utility of physiology-guided revascularization for decision-making in patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD) remains uncertain. The aim of this study is to...BACKGROUND: The clinical utility of physiology-guided revascularization for decision-making in patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD) remains uncertain. The aim of this study is to evaluate the diagnostic performance and prognostic significance of fractional flow reserve (FFR) and nonhyperemic pressure ratios (NHPRs) according to the severity of CKD. METHODS: This subanalysis of the J-PRIDE registry, a prospective multicenter study conducted at 20 Japanese centers between September 2019 and February 2021, included 4296 lesions from 3194 patients who underwent both FFR and NHPR assessment. Patients were categorized by estimated glomerular filtration rate into non-CKD (≥60 mL/min per 1.73 m; n=1639), CKD (15-59; n=1321), and ESRD (<15 or on dialysis; n=234). The primary end point was 1-year target vessel failure, defined as a composite of cardiac death, target vessel myocardial infarction, and clinically driven target vessel revascularization. RESULTS: The 1-year incidence of target vessel failure was significantly higher in the ESRD group than in CKD and non-CKD groups (8.4% versus 2.4% and 2.6%; for CKD, adjusted hazard ratio, 3.09 [95% CI, 1.60-5.96]; <0.001; for non-CKD, adjusted hazard ratio, 2.88 [95% CI, 1.98-5.47]; =0.001). The NHPR cutoff predicting FFR ≤0.80 was lower in ESRD compared with CKD and non-CKD (0.85 versus 0.89 versus 0.89). Although the overall prevalence of FFR/NHPR discordance was comparable (23.6%, 19.7%, and 19.7%; =0.24), FFR-/NHPR+ discordance predominated in ESRD (18.6% versus 9.3% versus 7.0%; <0.001). FFR-/NHPR+ lesions in the ESRD group exhibited an excess risk compared with other lesions. Revascularization was beneficial in non-CKD patients with FFR+/NHPR- lesions, whereas no clear benefit was observed in patients with CKD and ESRD. CONCLUSIONS: Patients with ESRD exhibited distinct physiological characteristics and substantially worse outcomes, highlighting the need for tailored coronary revascularization strategies in this population. REGISTRATION:URL: https://www.umin.ac.jp/ctr; Unique identifier: UMIN000038403.
BACKGROUND: There is limited published information on bioprosthetic aortic valve durability. The purpose of this study was to assess the durability of bioprosthetic valves used for aortic valve replacement (AVR) in pedia...BACKGROUND: There is limited published information on bioprosthetic aortic valve durability. The purpose of this study was to assess the durability of bioprosthetic valves used for aortic valve replacement (AVR) in pediatric patients. METHODS: We reviewed all surgical AVR procedures performed from May 02 to July 24 in patients ≤21 years of age using a mechanical valve or bioprosthesis. Long-term valve-related outcomes were assessed with propensity-score-adjusted analysis. RESULTS: During the study period, 180 AVR procedures were performed in pediatric patients (median age, 14.3 years) using a bioprosthetic valve (n=79) or mechanical prosthesis (n=101). Freedom from reintervention was significantly shorter in patients with a bioprosthetic valve (77% at 5 years, 29% at 10 years) than those with a mechanical valve (88% at 5 years, 82% at 10 years; <0.001). By propensity score-adjusted multivariable Cox regression, a bioprosthetic valve (hazard ratio, 4.66 [95% CI, 2.26-9.62]; <0.001) and age <12 years at AVR (3.26 [1.81-5.87]; <0.001) were associated with shorter freedom from reintervention. Endocarditis was diagnosed in 16 patients, and thromboembolic or bleeding complications were reported in 8. CONCLUSIONS: In pediatric patients undergoing AVR, bioprosthetic valves have significantly worse durability than mechanical prostheses, with the disparity most pronounced in younger patients. Valve-related mortality and complications were relatively common. These findings should focus attention on the need for better replacement valves or therapeutic options in young patients with aortic valve disease.
Sullivan AE, Behroozian A, Coolbaugh C
… +15 more, Shardelow E, Smith EK, Wells QS, Clair DG, Aday AW, Garrard CL, Curci JA, Holder TA, Barnett JV, Freiberg MS, Crescenzi RL, Wakeham DJ, Hearon CM, Donahue MJ, Beckman JA
BACKGROUND: Percutaneous coronary intervention (PCI) is a cornerstone treatment for coronary artery disease. As procedural volumes continue to rise, the associated radiation risk from angiography systems has drawn increa...BACKGROUND: Percutaneous coronary intervention (PCI) is a cornerstone treatment for coronary artery disease. As procedural volumes continue to rise, the associated radiation risk from angiography systems has drawn increasing concern. Thus, we developed a novel ultra-low-dose Noise-Free technology to optimize angiography systems. This study aims to investigate whether it effectively reduces radiation exposure in real-world coronary interventions. METHODS: A comparative study on a single-center, real-world, observational cohort. The primary end point was an intergroup comparison of procedural radiation exposure, including dose area product, air kerma, and dose rate, stratified by exposure mode (fluoroscopy or cine) and procedure type (diagnostic coronary angiography, single-vessel PCI, or chronic total occlusion PCI). The secondary end point included an expert semi-quantitative assessment and a quantitative contrast-to-noise ratio for image quality. RESULTS: A total of 380 procedures (102 coronary angiography, 78 single-vessel PCI, and 200 chronic total occlusion PCI) were performed in 380 patients using 4 different angiography systems. There was no significant difference in baseline patient characteristics, procedural time, or operator experience. In coronary angiography procedures, the ultra-low-dose technique demonstrated a total air kerma of 60.3 (38.5-74.1) mGy, total dose area product of 4.0 (2.9-5.2) Gy·cm, fluoroscopy dose rate of 7.9 (6.0-9.6) mGy/min, and cine dose rate of 51.7 (37.4-64.9) mGy/min, corresponding to 40% to 70%, 37% to 66%, 16% to 62%, and 25% to 79% reductions than others, respectively. Similar radiation reductions were observed for single-vessel PCI. For chronic total occlusion PCI, the corresponding percentages of radiation reduction in total air kerma, total dose area product, fluoroscopy dose rate, and cine dose rate were 59% to 73%, 54% to 69%, 22% to 64%, and 60% to 79%, respectively, relative to the other 3 systems. The semi-quantitative assessment and contrast-to-noise ratio analysis showed comparable image quality between the 4 systems. CONCLUSIONS: The Noise-Free technique reduced radiation exposure across cumulative and rate metrics while preserving diagnostic image quality, with the greatest reduction observed in complex cases. These findings support its clinical utility for lowering radiation risk.