Background/Objectives: Severe arterial calcification remains a major challenge during femoropopliteal endovascular intervention, limiting luminal gain and increasing the risk of vessel-wall injury, restenosis, and bailout stenting. Pulsatile intravascular lithotripsy (PIVL) is a novel calcium-modification technology that converts pneumatic pulses into short-duration hydraulic pressure waves delivered through a non-compliant balloon. POWER PAD I evaluated the first-in-human feasibility, safety, and procedural performance of PIVL in calcified femoropopliteal arterial disease. Methods: POWER PAD I was a prospective, single-arm, two-center feasibility study. Adults with Rutherford category 2–4 symptomatic peripheral arterial disease and moderately or severely calcified superficial femoral or popliteal lesions were treated with PIVL, followed by adjunctive therapy when clinically indicated. Angiographic and duplex ultrasound outcomes were assessed by an independent core laboratory, and adverse events were adjudicated by an independent clinical events committee. Results: Nine patients underwent treatment of 20 lesions. Mean age was 76.2 ± 12.6 years, 19 lesions were severely calcified, and five lesions were chronic total occlusions. Patient-level device and procedural success were each achieved in 8 of 9 patients; technical success was achieved in all patients. Mean diameter stenosis decreased from 76.5 ± 18.0% before treatment to 28.1 ± 6.9% after PIVL-containing lesion preparation and before adjunctive drug-coated-balloon angioplasty, and to 20.6 ± 5.8% after adjunctive therapy. Mean minimal luminal diameter increased from 1.3 ± 1.0 mm to 3.8 ± 0.5 mm after PIVL-containing lesion preparation and to 4.3 ± 0.6 mm at final angiography. No perforation, distal embolization, thrombus, abrupt closure, no-reflow, bailout stenting, or grade D or higher dissection occurred. Freedom from clinically driven target-lesion revascularization was 100% at 30 days and 6 months. Conclusions: PIVL-containing lesion preparation was feasible in heavily calcified superficial femoral and popliteal lesions and was associated with substantial acute luminal gain before adjunctive DCB therapy and no severe angiographic complications. Favorable 6-month clinical and patency outcomes were observed after the combined treatment strategy of PIVL vessel preparation and adjunctive DCB therapy; therefore, longer-term outcomes cannot be attributed to PIVL alone. Larger controlled studies are warranted.

Background:The prevalence and case fatality of ischemic heart disease in India has increased over the past 2 decades. ST-segment elevation myocardial infarction (STEMI) accounts for up to 60% of all myocardial infarctions in India, with only 25% to 40% of patients undergoing primary percutaneous coronary intervention (PPCI). A national access gap persists in India that needs to be bridged with the implementation of in-hospital processes and regional systems of collaborative care. Methods:The single-center, observational, retrospective Myocardial Infarction Delhi Primary Angioplasty Study (MIDAS) was conducted at Max Super Specialty Hospital (New Delhi, India) between January 1, 2015, and December 31, 2019. All patients presenting to the emergency department with ongoing chest discomfort suggestive of ischemia and ST elevation on electrocardiogram were included. PPCI, initiated by a "CODE STEMI" team activation call, was employed as a single reperfusion strategy to treat all patients and minimize system delays. Systematic data collection of door-to-balloon (D2B) time regular audit, feedback, and multidisciplinary team engagement was implemented to refine processes and improve efficiency. The consistency of the process in maintaining D2B time during day and night hours, as well as on weekends and holidays was evaluated. Data from the electronic health record were collected and summarized to evaluate the impact of processes on in-hospital patient outcomes. Results:A total of 887 patients meeting eligibility criteria were included in the analysis, of whom 45.2% were admitted during off hours, weekends, or holidays, and 92.3% underwent PPCI, 2.8% underwent PPCI followed by CABG, 1.8% underwent CABG, and 2.6% required medical therapy. The median D2B was 51 minutes (interquartile range, 40-60 minutes), and on holidays the mean D2B was 55 minutes (interquartile range, 40-75 minutes). The overall mortality was 5.2%. Conclusions:This study demonstrates that implementing a team-based standardized protocol can achieve guideline-recommended D2B times in a diverse STEMI population presenting to a percutaneous coronary intervention-capable hospital. Protocols reduce variation in care and enable the delivery of equitable high-quality care consistently across diverse demographic groups.

Background:The Ringer perfusion catheter (Teleflex) features a novel design with a spiral-shaped inflatable balloon that approximates a hollow cylinder when inflated to manage hemorrhage associated with coronary artery perforation (CAP) during percutaneous coronary intervention while enabling distal perfusion. Methods:In a multicenter, prospective, single-arm study, the safety and efficacy of using the Ringer device in the treatment of CAP were assessed. The primary efficacy end point included successful Ringer delivery across the perforation site, angiographic confirmation of no extravasation with balloon inflation, and demonstration of antegrade coronary flow. The primary safety end point was freedom from device-related thrombosis and coronary dissection. Clinical and angiographic outcomes were independently adjudicated. Results:Among 30 patients with CAP, lesion characteristics included: chronic total occlusion, 50%; severe calcification, 63.3%; lesion length 34.1 ± 23.4 mm. Ellis type II and III perforations occurred in 50% and 30% of patients, respectively. For all patients, the primary efficacy end point was 73.3% by intention to treat analysis. However, among the 26 patients with successful Ringer delivery across the perforation site, the primary end point was 84.6%. In this latter group, acute resolution of contrast extravasation was 84.6%, and maintenance of thrombolysis in myocardial infarction 2/3 antegrade flow during device inflation was 100%. No device-related safety events were observed. Conclusions:Treatment of CAP with a novel perfusion balloon catheter achieved favorable rates of deliverability and reduction in hemorrhage while maintaining antegrade flow. These results demonstrate that the Ringer perfusion catheter is a safe and effective method to manage CAP until definitive treatment is decided.

Cardiovascular disease is the leading cause of death for women worldwide, with mortality rates due to cardiogenic shock (CS) remaining exceedingly high. Sex-based disparities in the timely delivery of optimal CS treatment contribute to poor outcomes; addressing these disparities is a major priority to improve women’s cardiovascular health. This consensus statement provides a comprehensive summary of the current state of treatment of CS in women across the spectrum of cardiovascular disease states and identifies important gaps in evidence. As sex-based data are limited in contemporary literature, clinicians may use this document as a resource to guide practice. Further investigations are necessary to inform best practices for the diagnosis and treatment of women with CS.

Background:The 30-day Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) has been used to risk-stratify patients undergoing transcatheter aortic valve replacement (TAVR). Whether surgical mortality risk predicts stroke and neurocognitive outcomes following TAVR is unknown. We evaluated the association between STS-PROM and clinical outcomes, including stroke, acute brain injury on diffusion-weighted magnetic resonance imaging (DW-MRI), and cognitive decline in patients undergoing TAVR. Methods:Patient-level data were pooled from 4 prospective trials: (1) DEFLECT III (N = 87), (2) NeuroTAVR (N = 44), (3) REFLECT I (N = 214), and (4) REFLECT II (N = 258). All studies included patients undergoing TAVR with a protocol-mandated predischarge DW-MRI and serial cognitive and neurologic assessments. All patients were evaluated by a board-certified neurologist at baseline, postprocedure, and 30 days. Clinical outcomes, including stroke, cognitive decline (Montreal Cognitive Assessment score), death, myocardial infarction, vascular, and bleeding complications were adjudicated by the same clinical events committee. Imaging analysis was performed by a single core laboratory using identical methods. The DW-MRI measures included total lesion number, individual lesion volume, and total lesion volume. Outcomes were compared between low (STS <4), intermediate (STS 4-8), and high (STS >8) risk groups. Results:In total, 537 of 603 patients with DW-MRI and complete STS assessment undergoing transfemoral TAVR were included in this pooled analysis, of which 253 (47%) were low risk, 198 (37%) intermediate risk, and 86 (16%) high risk patients. At 30 days, high risk patients had higher rates of all-cause and cardiovascular mortality, myocardial infarction, acute kidney injury, bleeding, and vascular complications. Rates of stroke, disabling stroke, DW-MRI measures of brain injury, and cognitive decline were similar across risk categories. Conclusions:This pooled analysis demonstrates that the STS score does not predict stroke, cognitive decline, or acute brain injury after TAVR.

OBJECTIVE:To investigate the long-term prognosis of coronary microvascular dysfunction (CMD) in emergency department (ED) patients with chest pain for major adverse cardiac events (MACE) due to all-cause mortality, myocardial infarction (MI), heart failure (HF), or stroke. METHODS:A prospective cohort of ED patients evaluated by hybrid cardiac positron emission tomography with attenuation computed tomography within 24 h of arrival. Patients were classified as: (1) Controls - coronary flow reserve (CFR) ≥2 without perfusion defect or coronary calcification; (2) CMD: CFR <2 without defect or calcification; or (3) CAD/CALC - established or new coronary artery disease (CAD) or calcification (CALC). We conducted annual follow-ups for MACE and all-cause healthcare utilization (hospitalizations and ED visits). We adjusted incidence rates (aIR) and hazard ratio (aHR) for demographics, comorbidities, and medications. RESULTS:Between 2014 and 2020, 189 patients were enrolled: 95 (50 %) Controls, 34 (18 %) with CMD, and 60 (32 %) with CAD/CALC. Median follow-up time was 50 months (38-92), and a total of 187 unique MACE were recorded in 44 patients. CMD patients had 4× higher MACE risk than controls (aIR 3.8; 95 % CI: 2.1-6.6). CAD/CALC patients had similarly higher risk than controls (aIR: 4.5; 95 % CI: 2.6-7.8). CMD patients had 4× higher risk for time to first MACE than controls (aHR: 3.6; 95 % CI: 1.2-10.7) and higher healthcare utilization per 100 person-months (aIR: 124; 95 % CI: 119-130). Using Seattle Angina Questionnaire, CMD patients showed worse angina frequency than controls (difference: -16.4, 95 % CI: -29.5 to -3.4). CONCLUSIONS:Patients with contemporary phenotypes of ischemia (CMD and CAD/CALC) had higher adverse events than controls, positing ED encounters as an opportunity for early identification and treatment.

[This corrects the article DOI: 10.1016/j.jscai.2024.102432.].

Background To understand the relative safety and efficacy of endovascular treatment modalities used for superficial femoral artery (SFA) disease, we performed a network meta-analysis to compare outcomes between percutaneous transluminal angioplasty (PTA), atherectomy (A), bare metal stent (BMS), brachytherapy/radiotherapy, covered stent graft (CSG), cutting balloon angioplasty (CBA), drug-coated balloon (DCB), drug-eluting stent (DES), and intravascular lithotripsy (L). Methods We performed a systematic literature search of PubMed from January 2000 to January 2023 to identify randomized trials comparing endovascular interventions for the treatment of SFA disease. The primary end points were technical success and 12-month primary patency. Results In total, 57 studies (9089 patients) were included. The mean age of the included patients was 68.4 years, 41.4% had diabetes, 18.3% had critical limb ischemia, and 81.3% had de novo lesions. A mean of 1.2 lesions were treated per patient. Technical success was superior for CSG, BMS, and A+DCB compared with PTA, while A+DCB and CSG were superior to DCB. All interventions except brachytherapy alone had superior primary patency compared with PTA. There were no significant differences in 12-month mortality or major amputation. All interventions except L+DCB, PTA+A, and CBA were superior to PTA regarding target lesion revascularization, while only DCB, DES, and BMS were better than PTA at improving Rutherford classification. Conclusions In SFA disease, PTA alone is mostly inferior to other endovascular techniques. This comparison of other endovascular techniques will be valuable for endovascular device selection in the treatment of SFA disease.

Background In patients undergoing high‐risk percutaneous coronary intervention, Impella has become an important adjunctive tool to support revascularization. The impact of age on the outcomes of patients undergoing high‐risk percutaneous coronary intervention is limited. The aim of this study is to describe the characteristics and outcomes of patients ≥75 years of age undergoing Impella‐supported high‐risk percutaneous coronary intervention. Methods and Results Baseline characteristics and outcomes of patients ≥75 years of age versus those of patients <75 years of age in patients enrolled in the cVAD PROTECT III (Catheter‐Based Ventricular Assist Device Prospective, Multi‐Center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump in Patients Undergoing Non Emergent High Risk Percutaneous Coronary Intervention) study (NCT04136392). Major adverse cardiovascular and cerebral events (composite of all‐cause death, nonfatal myocardial infarction, stroke/transient ischemic attack, and repeat revascularization) were assessed at 30 and 90 days and all‐cause death at 1 year. Out of 1237 patients, 493 (39.9%) patients were ≥75 years of age. Patients ≥75 years of age had less diabetes and prior myocardial infarction, more hypertension and dyslipidemia, worse renal function, more severe valvular heart disease, but higher left ventricular ejection fraction (P<0.05 for all comparisons). Baseline Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores were similar between groups. Older patients underwent more left main percutaneous coronary intervention (58% versus 39%; P<0.0001), atherectomy (32% versus 22%; P<0.0001), and femoral access (87% versus 79%, P=0.0003) as compared with younger patients. In‐hospital vascular complications did not differ, but rates of respiratory failure, pericardial tamponade, and cardiogenic shock were higher in older patients. Rates of all‐cause death and major adverse cardiovascular and cerebral events did not differ between groups at 30 and 90 days. Rates of all‐cause death at 1 year were higher in patients ≥75 years (adjusted hazard ratio, 1.99 [95% CI, 1.24–3.18], P=0.004). Conclusions Impella‐supported high‐risk percutaneous coronary intervention in older patients is feasible with an acceptable safety profile. However, age ≥75 years remained a statistically significant predictor for all‐cause death at 1 year. Registration URL: https://clinicaltrials.gov; Unique Identifier: NCT04136392.

Cardiovascular disease is the leading cause of death for women worldwide, with mortality rates due to cardiogenic shock (CS) remaining exceedingly high. Sex-based disparities in the timely delivery of optimal CS treatment contribute to poor outcomes; addressing these disparities is a major priority to improve women's cardiovascular health. This consensus statement provides a comprehensive summary of the current state of treatment of CS in women across the spectrum of cardiovascular disease states and identifies important gaps in evidence. As sex-based data are limited in contemporary literature, clinicians may use this document as a resource to guide practice. Further investigations are necessary to inform best practices for the diagnosis and treatment of women with CS.

Objectives. The financial well-being of cardiologists has received limited study. Methods. The authors performed an online, anonymous, international survey of the financial well-being of cardiologists from June to August 2024. Results. Three hundred thirty-eight attending cardiologists participated in this survey. Most were from the United States (78%), men (89%), and had a median age of 46 to 50 years. US participants had a median yearly income of $600 000 to $699 000, spent a median of 60 hours/week at work, had a median of 5 weeks/year of vacation, and 14.5% had college/medical school debt. Median incomes varied by practice type: university ($500 000-$599 000), private group ($700 000-$799 000), and community hospital ($700 000-$799 000). Less than half (44%) of the US participants received cardiology-related income such as royalties, 9% took locum/moonlighting shifts, and most (55%) had individual, own- occupation, specialty-specific disability insurance. Most (79%) were married and never divorced. Most (73%) led family financial planning, 59% had an investment advisor, 91% used tax-advantaged investment accounts, 70% knew where their money was invested, and 28% owned real estate with tenants. The median net worth of the US participants was $3 to $5 million, and 78% had a retirement net worth goal, with a median target of approximately $10 million. Half (50%) had trust and estate planning. One-third (32%) of the US participants said they would take a 25% pay cut to work 25% less. Multiple linear regression analysis showed that past divorce and longer work hours were associated with emotional exhaustion, while higher net worth was associated with higher life satisfaction and less emotional exhaustion. Conclusions. The survey provides novel insights into the financial well-being of cardiologists.

Background:Robotic percutaneous coronary intervention (R-PCI) reduces occupational hazards for interventional cardiologists. However, there is a lack of clinical data in a large patient cohort. The aims of this study were to evaluate the safety and efficacy of R-PCI with both the first (CorPath 200) and second (CorPath GRX) (Corindus, Siemens Company) generation robotic systems. Methods:These prospective, multicenter, single-armed studies enrolled patients with symptomatic coronary artery disease from 2013-2017 (PRECISION; CorPath 200) and 2017-2020 (PRECISION GRX; CorPath GRX). The primary outcome measures were clinical success, defined as <30% residual stenosis in the absence of major adverse cardiovascular events, and technical success, defined as clinical success without conversion to manual PCI. Results:A total of 1734 R-PCI procedures (PRECISION: 754 procedures, 950 lesions; PRECISION GRX: 980 procedures, 1233 lesions) were performed. Clinical (96.9% and 98.1% PRECISION and PRECISION GRX respectively, P = ns) and technical (89.6% and 89.2% PRECISION and PRECISION GRX respectively, P = ns) success rates were similar. Higher clinical success rates were observed in moderate/severe calcification lesions, bifurcation lesions, and long lesions with the second-generation system, and higher technical success rates were observed with the second-generation system in moderate/severe calcification lesions, bifurcation lesions, and angulated lesions. Conclusions:This multicenter experience with R-PCI demonstrates high clinical and technical success for patients treated with either the first- or second-generation robotic platform. Clinical and technical success rates with the second-generation robotic platform were higher for several complex lesion types. These data support the safety and efficacy of R-PCI in clinical practice.

Background Percutaneous left ventricular assist devices are used prophylactically to prevent hypotension during high‐risk percutaneous coronary intervention. However, the impact of preprocedural hemodynamic profiles on procedural and clinical outcomes in these patients is unknown. Methods and Results Patients from the central venous access device PROTECT III registry (NCT04136392) were categorized according to preprocedural mean blood pressure (MBP). Procedural and in‐hospital outcomes, including hypotensive episodes, need for prolonged percutaneous left ventricular assist device support, and in‐hospital death, were compared between groups. We also assessed the relationship between preprocedural MBP and 90‐day major adverse cardiovascular and cerebrovascular events, which included all‐cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization, as well as with 1‐year mortality. A total of 1159 patients underwent percutaneous left ventricular assist device‐supported high‐risk percutaneous coronary intervention and were stratified into 4 hemodynamic profiles of preprocedural MBP level: MBP>100 mm Hg (n=242), >90 to ≤100 mm Hg (n=264), >80 to ≤90 mm Hg (n=306), and ≤80 mm Hg (n=347). Lower preprocedural MBP was associated with baseline anemia, history of heart failure, left main disease, and transfer from another hospital. In‐hospital and procedural adverse outcomes did not differ between the BP categories. However, 90‐day major adverse cardiovascular and cerebrovascular events rates and 1‐year mortality increased with decreasing baseline BP levels. The association between BP category and 1‐year mortality remained significant after adjustment for other factors (hazard ratio [HR], 0.79 [95% CI, 0.71–0.88], P<0.001). Conclusions In a real‐world cohort undergoing high‐risk percutaneous coronary intervention with percutaneous left ventricular assist device support, there was no association between hemodynamic status and in‐hospital outcomes. Lower preprocedural BP was associated with higher rates of 90‐day major adverse cardiovascular and cerebrovascular events and 1‐year mortality. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04136392.