Background Iodinated contrast used during percutaneous coronary intervention (PCI) risks contrast-induced acute kidney injury. Reducing this risk is essential as PCI procedures become more complex. Dynamic Coronary Roadmap (DCR) is a PCI tool that overlays a virtual roadmap on fluoroscopy and has been shown to reduce contrast use. Methods This secondary analysis from the Dynamic Coronary Roadmap for Contrast Reduction study evaluates the feasibility of obtaining high-quality roadmaps suitable for PCI, its influence on contrast reduction and the relationship between PCI complexity and roadmap quality, and its effect on the contrast-sparing capabilities of DCR compared with standard angiographic guidance. The study was prospective and randomized, conducted in 6 centers across Europe (n = 3), Israel (n = 1), and the United States (n = 2). Patients were assigned to either DCR guidance or conventional guidance, and contrast usage and roadmap quality were compared. Results The study included 365 patients (181 DCR and 184 control). Both groups were comparable in demographics and procedure characteristics. The DCR arm showed clinically usable roadmap quality in 97.2% of cases. Contrast volume was significantly lower with DCR guidance and lowest when the roadmap scored better: 63.5 ± 50.3 mL for “DCR good” (n = 147) vs 79.3 ± 42.8 mL for “DCR fair/poor” (n = 34) vs 90.2 ± 53.3 mL for “Control” (n = 184) (P < .001). DCR’s efficacy increased with PCI complexity (using the SYNTAX score of the treated vessel [SSv] as an index): 71.4% of first tertile (SSv < 4), 79.7% of second tertile (4 ≤ SSv < 8), and 93.1% of third tertile (SSv ≥ 8) scored “very good” or “good” (P < .05). Conclusions This multicenter study shows that DCR technology provides consistent high-quality roadmap support, reducing iodinated contrast usage significantly, particularly as PCI complexity increases.
Transcatheter aortic valve replacement (TAVR) has become a widely accepted procedure for treating patients with symptomatic aortic stenosis. While transfemoral access remains the primary route due to its lower complication rates and favorable outcomes, a subset of patients have anatomical or clinical factors precluding this approach. For these patients, alternative access routes such as transaxillary, transcarotid, and transcaval provide viable options. This expert consensus statement aims to provide a comprehensive review of case selection, technical considerations, and outcomes associated with these alternative access routes in TAVR. Additionally, this document highlights the advancements in device technology and imaging guidance that have contributed to improving the safety and efficacy of alternative access TAVR. This consensus statement serves as a practical guide on best practices for interventional cardiologists, cardiothoracic surgeons, and heart teams in selecting patients and performing alternative access TAVR.
OBJECTIVE:Thoracic endovascular aortic repair (TEVAR) and transcatheter aortic valve replacement (TAVR) necessitate large-bore arterial access for stent/valve delivery. With improvement of device delivery technology, percutaneous access has become the standard. This may be associated with fewer complications, although the literature is conflicting. The purpose of this study was to compare the outcomes of open versus percutaneous large-bore arterial access at a single institution. METHODS:A total of 1,018 patients who underwent TEVAR or TAVR between 2006 and 2022 were included. Only groins accessed for delivery sheath were included in the analysis, with sizes ranging from 12 to 28 Fr. Access complications included bleeding (hematoma, perforation, rupture, pseudoaneurysm), infection, seroma, dissection, and distal embolization. RESULTS:Delivery sites were successfully closed using a median of 2 percutaneous closure devices. Larger sheath diameter was associated with conversion to open (20 Fr vs 16 Fr, P = 0.004). There was a significantly higher rate of total complications (35.0% vs 8.6%, P < 0.001), infection, bleeding, seroma, dissection, and distal embolization in open compared with percutaneous cases. Multivariable analysis confirmed a significantly lower rate of complication with the percutaneous approach relative to the open approach (odds ratio = 0.17, P < 0.001). CONCLUSIONS:Percutaneous access is associated with significantly lower rates of total complications, infection, bleeding, dissection, and distal embolization when compared with surgical cutdown. Delivery sheath size was associated with conversion to open arteriotomy closure, but the overall incidence was low. Large-bore arterial access closure can be safely achieved using a percutaneous strategy, resulting in fewer complications than with the open approach.
Background:Interventional cardiology (IC) is well suited to simulation education, with a wide spectrum of digital and physical models for procedural training. Despite this, standardization, validation, and access to simulation training remains inconsistent in the United States and globally. Ten years have elapsed since the last Society for Cardiovascular Angiography & Interventions (SCAI) expert consensus statement on simulation in IC, which included a survey of US program directors. In this document, we report the results of a follow-up survey with the goal of broadening polling to all career stages, both in the US and internationally. Methods:A web-based 19-item survey with embedded subquestions was sent out via email solicitation to SCAI members from September 2023 to December 2023. Results:In total, 420 responses were collected, with a 15% response rate. Nearly 70% of respondents were from the US. There was equal distribution in responses for all stages of training, with most respondents performing coronary procedures. Two-thirds had previous exposure to simulation training with most using digital simulators and reporting only 1 to 2 days of exposure for each type or procedure. A majority (71%) felt that they had insufficient simulation training; most felt that simulation fidelity was average. The biggest barrier to simulation training was a lack of access. Conclusions:Despite efforts to develop simulation in IC training, there remain gaps in accessibility, exposure, and curricula. Professional organizations, industry, and educational governing bodies must collaborate on specific, actionable strategies to enhance access to high-fidelity IC simulation training globally.
[This corrects the article DOI: 10.1016/j.jscai.2024.102514.].
BACKGROUND:The American College of Cardiology, American Heart Association, and Centers for Medicare and Medicaid Services recommend shared decision-making (SDM) for patients with severe aortic stenosis choosing between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). Although tools such as patient decision aids (DAs) and training in SDM have been shown to improve SDM, implementation of SDM and DAs is limited. The IMproving treatment decisions for Patients with AortiC stenosis Through Shared Decision Making (IMPACT SDM) study aims to (1) determine the effectiveness of the interventions (a DA and clinician SDM training) in achieving SDM (primary outcome) and improving the quality of decisions about aortic valve replacement, (2) determine the reach of the DAs and adoption of training, and (3) explore potential mechanisms of effectiveness and implementation at the patient-, clinician-, and clinic-level. METHODS:The study is a hybrid type II effectiveness-implementation study using a cluster randomized batched stepped wedge trial with 8 sites across the USA. Eligible patients will be surveyed before and after visits with the heart valve team; clinicians will be surveyed after visits. Reach of DAs and adoption of training will be tracked. Clinicians will be interviewed regarding barriers and facilitators to implementation. DISCUSSION:The IMPACT SDM Study seeks to provide evidence of the ability of the interventions to improve SDM and decision quality, and also to shed light on barriers and facilitators to SDM implementation to promote future implementation efforts. TRIAL REGISTRATION:ClinicalTrials.gov NCT06171737. Registered on December 15, 2023.
Identification of long-term calcium channel blocker (CCB) responders with acute vasodilator challenge is critical in the evaluation of patients with pulmonary arterial hypertension. Currently there is no standardized approach for use of supplemental oxygen during acute vasodilator challenge. In this retrospective analysis of patients identified as acute vasoresponders, treated with CCBs, all patients had hemodynamic measurements in three steps: (1) at baseline; (2) with 100% fractional inspired oxygen; and (3) with 100% fractional inspired oxygen plus inhaled nitric oxide (iNO). Those meeting the definition of acute vasoresponsiveness only after first normalizing for the effects of oxygen in step 2 were labeled "iNO Responders." Those who met the definition of acute vasoresponsiveness from a combination of the effects of 100% FiO2 and iNO were labeled "oxygen responders." Survival, hospitalization for decompensated right heart failure, duration of CCB monotherapy, and functional data were collected. iNO responders, when compared to oxygen responders, had superior survival (100% vs. 50.1% 5-year survival, respectively), fewer hospitalizations for acute decompensated right heart failure (0% vs. 30.4% at 1 year, respectively), longer duration of CCB monotherapy (80% vs. 52% at 1 year, respectively), and superior 6-min walk distance. Current guidelines for acute vasodilator testing do not standardize oxygen coadministration with iNO. This study demonstrates that adjusting for the effects of supplemental oxygen before assessing for acute vasoresponsiveness identifies a cohort with superior functional status, tolerance of CCB monotherapy, and survival while on long-term CCB therapy.
A 51-year-old patient with progressive right heart dysfunction was found to have a large calcified right atrial mass on echocardiography. As part of the work up for an intracardiac mass he had a cardiac computed tomogram which detailed a large coronary cameral fistula from the circumflex coronary artery to the right atrium associated with a spherical calcific pseudo-aneurysmal sac. Transcatheter occlusion of the exit point into the atrium with a vascular plug was performed directly from a right atrial approach without the need for an arteriovenous wire loop. This case details a unique presentation of a coronary cameral fistula to an unusual position within the right atrium which facilitated the rare ability to occlude the fistula from a venous approach without creating an arteriovenous wire rail.
BACKGROUND: The American College of Cardiology Reduce the Risk: PCI Bleed Campaign was a hospital-based quality improvement campaign designed to reduce post-percutaneous coronary intervention (PCI) bleeding events. The aim of the campaign was to provide actionable evidence-based tools for participants to review, adapt, and adopt, depending upon hospital resources and engagement. METHODS: We used data from 8 757 737 procedures in the National Cardiovascular Data Registry between 2015 and 2021 to compare patient and hospital characteristics and bleeding outcomes among campaign participants (n=195 hospitals) and noncampaign participants (n=1384). Post-PCI bleeding risk was compared before and after campaign participation. Multivariable hierarchical logistic regression was used to determine the adjusted association between campaign participation and post-PCI bleeding events. Prespecified subgroups were examined. RESULTS: Campaign hospitals were more often higher volume teaching facilities located in urban or suburban locations. After adjustment, campaign participation was associated with a significant reduction in the rate of bleeding (bleeding: adjusted odds ratio, 0.61 [95% CI, 0.53–0.71]). Campaign hospitals had a greater decrease in bleeding events than noncampaign hospitals. In a subgroup analysis, the reduction in bleeding was noted in non–ST-segment–elevation acute coronary syndrome and ST-segment–elevation myocardial infarction patients, but no significant reduction was seen in patients without acute coronary syndrome. CONCLUSIONS: Participation in the American College of Cardiology Reduce the Risk: PCI Bleed Campaign was associated with a significant reduction in post-PCI bleeding. Our results underscore that national quality improvement efforts can be associated with a significant impact on PCI outcomes.
INTRODUCTION:Despite the growing adoption of transcatheter aortic valve replacement (TAVR), there remains a lack of clinical data evaluating procedural safety and discharge practices. AIMS:This study aims to investigate if there have been improvements in postoperative clinical outcomes following TAVR. METHODS:In this large-scale, retrospective cohort study, patients who underwent TAVR as an inpatient were identified from 2016 to 2020 using the National Readmissions Database. The primary outcome was temporal trends in the rates of discharge to home. Secondary endpoints assessed annual discharge survival rates, 30-day readmissions, length of stay, and periprocedural cardiac arrest rates. RESULTS:Over the 5-year study period, a total of 31,621 inpatient TAVR procedures were identified. Of these, 79.2 % of patients were successfully discharged home with home disposition increasing year-over-year from 74.5 % in 2016 to 85.9 % in 2020 (Odds ratio: 2.01; 95 % CI 1.62-2.48, p < 0.001). The mean annual discharge survival rate was 97.7 % which did not change significantly over the 5-year study period (p = 0.551). From 2016 to 2020, 30-day readmissions decreased from 14.0 % to 10.3 %, respectively (p = 0.028). Perioperative cardiac arrest occurred in 1.8 % (n = 579) of cases with rates remaining unchanged during the study (p = 0.674). CONCLUSION:Most TAVR patients are successfully discharged alive and home, with decreasing 30-day readmissions observed over recent years. This data suggests potential improvements in preoperative planning, procedural safety, and postoperative care. Despite perioperative cardiac arrest being associated with high mortality, it remains a relatively rare complication of TAVR.
Delays in initiation of targeted temperature management (TTM) have been observed in randomized trials evaluating immediate or delayed coronary angiography among survivors of ventricular tachycardia (VT) or ventricular fibrillation (VF) out-of-hospital cardiac arrest (OHCA), but whether delays are associated with adverse clinical outcomes is unknown. Resuscitated survivors of VT/VF OHCA who received TTM between April 2011 and June 2015 were identified and time to TTM initiation was described. The association between TTM initiation <2 versus >= 2 hours, neurologically favorable, and overall survival to hospital discharge was assessed. In a propensity-weighted analysis of 2954 patients, a significantly larger proportion of patients undergoing percutaneous coronary intervention (PCI) had TTM initiation >= 2 hours (48.6%) as compared to patients undergoing angiography (41.4%) or those who did not undergo a procedure (33.0%; p < 0.001 for all comparisons). In this cohort, the odds of neurologically favorable survival (odds ratios [OR]: 0.88, 95% confidence intervals [CI] = 0.75-1.02) and overall survival (OR: 0.92, 95% CI = 0.83-1.03) to hospital discharge were similar among ST-elevation myocardial infarction (STEMI) patients who underwent PCI with TTM initiation <2 versus >= 2 hours. Patients without STEMI who underwent PCI with TTM initiation >= 2 hours and did not have a "do not resuscitate" order or withdrawal of life-sustaining care had decreased odds of neurologically favorable survival to hospital discharge (OR: 0.45, 95% CI = 0.22-0.93) compared to TTM initiation <2 hours. PCI was associated with delays in TTM initiation >= 2 hours among resuscitated survivors of VT/VF OHCA. Delays in TTM initiation >= 2 hours were associated with decreased odds of neurologically favorable survival among patients without STEMI who underwent PCI.
HomeJournal of the American Heart AssociationVol. 13, No. 5Heterogeneity in the Prognosis of Acute Kidney Injury Following Percutaneous Coronary Intervention Open AccessRapid CommunicationPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toOpen AccessRapid CommunicationPDF/EPUBHeterogeneity in the Prognosis of Acute Kidney Injury Following Percutaneous Coronary Intervention Jiun‐Ruey Hu, Karthik Murugiah, Xin Xin, Mitsuaki Sawano, Yuan Lu, F. Perry Wilson, Frederick A. Masoudi, John C. Messenger, Harlan M. Krumholz and Chenxi Huang Jiun‐Ruey HuJiun‐Ruey Hu https://orcid.org/0000-0003-1390-508X , Center for Outcomes Research and Evaluation, , Yale‐New Haven Hospital, , New Haven, , CT, , USA, , Section of Cardiovascular Medicine, Department of Internal Medicine, , Yale School of Medicine, , New Haven, , CT, , USA, , Karthik MurugiahKarthik Murugiah https://orcid.org/0000-0001-7932-382X , Center for Outcomes Research and Evaluation, , Yale‐New Haven Hospital, , New Haven, , CT, , USA, , Section of Cardiovascular Medicine, Department of Internal Medicine, , Yale School of Medicine, , New Haven, , CT, , USA, , Xin XinXin Xin https://orcid.org/0000-0002-0223-923X , Center for Outcomes Research and Evaluation, , Yale‐New Haven Hospital, , New Haven, , CT, , USA, , Mitsuaki SawanoMitsuaki Sawano https://orcid.org/0000-0003-2789-1758 , Center for Outcomes Research and Evaluation, , Yale‐New Haven Hospital, , New Haven, , CT, , USA, , Yuan LuYuan Lu https://orcid.org/0000-0001-5264-2169 , Center for Outcomes Research and Evaluation, , Yale‐New Haven Hospital, , New Haven, , CT, , USA, , F. Perry WilsonF. Perry Wilson https://orcid.org/0000-0002-2633-2412 , Section of Nephrology, Department of Medicine, , Yale School of Medicine, , New Haven, , CT, , USA, , Frederick A. MasoudiFrederick A. Masoudi https://orcid.org/0000-0002-5681-6709 , Ascension Health, , St. Louis, , MO, , USA, , Division of Cardiology, Department of Medicine, , University of Texas at Austin Dell Medical School, , Austin, , TX, , USA, , John C. MessengerJohn C. Messenger https://orcid.org/0000-0003-0501-1000 , Division of Cardiology, Department of Medicine, , University of Colorado School of Medicine, , Aurora, , CO, , USA, , Harlan M. KrumholzHarlan M. Krumholz https://orcid.org/0000-0003-2046-127X , Center for Outcomes Research and Evaluation, , Yale‐New Haven Hospital, , New Haven, , CT, , USA, , Section of Cardiovascular Medicine, Department of Internal Medicine, , Yale School of Medicine, , New Haven, , CT, , USA, , Department of Health Policy and Management, , Yale School of Public Health, , New Haven, , CT, , USA, and Chenxi HuangChenxi Huang * Correspondence to: Chenxi Huang, PhD, Center for Outcomes Research and Evaluation, Yale‐New Haven Hospital, 195 Church Street, Sixth Floor, New Haven, CT 06510. Email: E-mail Address: [email protected] https://orcid.org/0000-0001-8624-4652 , Center for Outcomes Research and Evaluation, , Yale‐New Haven Hospital, , New Haven, , CT, , USA, Originally published23 Feb 2024https://doi.org/10.1161/JAHA.123.033649Journal of the American Heart Association. 2024;13:e033649Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: February 23, 2024: Ahead of Print Acute kidney injury (AKI) affects 7% of patients who undergo percutaneous coronary intervention (PCI) and is associated with increased in‐hospital and long‐term mortality.1 Reducing rates of AKI has been a focus of quality improvement initiatives.2 The National Cardiovascular Data Registry (NCDR) CathPCI registry reports risk‐adjusted rates of AKI following PCI as a hospital performance metric.However, post‐PCI AKI is currently measured as a binary event based on a serum creatinine (SCr) increase of ≥50% or ≥0.3 mg/dL.3 This approach has several shortcomings. An equal increase in SCr represents different degrees of decrease in estimated glomerular filtration rate for different baseline renal function. Further, the prognostic effect of an AKI event could vary based on the degree of AKI and on the patient's baseline renal function.In order to better characterize the prognostic implications of AKI with respect to baseline SCr, we assessed the association of AKI with 30‐day all‐cause mortality by levels of preprocedural baseline SCr and AKI severity using the NCDR CathPCI registry linked with Medicare claims.4 The area under the curve for the NCDR model was 0.85 for predicting 30‐day mortality.Data are available, upon request, from the American College of Cardiology NCDR in Washington, DC at https://cvquality.acc.org/NCDR‐Home.We included all PCIs from the 2016 CathPCI registry among Medicare fee‐for‐service beneficiaries. PCIs with missing SCr measurement pre‐ or post‐PCI, patients on dialysis pre‐PCI, and PCIs with preprocedural SCr >4 mg/dL (99.5th percentile) were excluded. Post‐PCI AKI was defined as a rise in SCr ≥0.3 mg/dL or ≥50%, in accordance with the Acute Kidney Injury Network and Kidney Disease Improving Global Outcomes guidelines.3 Stage II/III AKI was defined as a rise in SCr of ≥200%. We first tested the existence of an interaction between AKI and baseline SCr in the association with mortality. We then used a generalized additive model with a logic link function separately for stage I and stage II/III AKI to quantify this association, using penalized thin plate regression splines to accommodate nonlinearity. Nonlinearity was assessed via F‐tests. We adjusted for variables in the validated NCDR mortality model, including estimated glomerular filtration rate, ejection fraction, chronic lung disease, diabetes, and prior PCI.5 We performed these analyses separately for (1) elective PCI and (2) PCI for acute myocardial infarction (AMI), as these represent 2 distinct clinical syndromes. The Yale University Institutional Review Board approved the study and waived informed consent.The study cohort included 117 353 PCIs (33.6% elective and 41.3% for AMI) among 103 714 Medicare beneficiaries. The mean (SD) patient age was 75.0 (7.0) years; 36.1% were female. Baseline glomerular filtration rate was 67.4 mL/min per 1.73 m2. Of the study cohort, 46 909 (40%) had diabetes, 51 669 (44%) had prior PCI, and 27 208 (23%) had prior coronary artery bypass grafting. AKI occurred in 10 144 (8.6%); 8262 (7.0%) were stage I, and 1882 (1.6%) were stage II/III AKI. The interaction of AKI and baseline SCr in the association with mortality was significant for both elective PCIs (P=0.035) and for AMI (P=0.001).In elective PCIs, the variation of adjusted odds ratio (OR) of AKI for mortality across baseline SCr was significant for stage II/III AKI (P=0.026) but not for stage I AKI (P=0.064; Figure). For both stage I and stage II/III AKIs, the OR for mortality was lower at higher baseline SCr. In patients with a baseline SCr of 1.0 mg/dL, the OR for mortality was 4.0 (95% CI, 2.7–6.1) for those with stage I AKI and 34.0 (95% CI, 21.2–54.6) for those with stage II/III AKI, compared with those without AKI. Whereas in patients with a baseline SCr of 4.0 mg/dL, the OR for mortality was 0.7 (95% CI, 0.1–3.1) for those with stage I AKI and 0.4 (95% CI, 0.0–8.8) for those with stage II/III AKI, compared with those without AKI.Download figureDownload PowerPointFigure . Adjusted odds ratios for 30‐day all‐cause mortality associated with acute kidney injury (AKI) in patients who underwent elective percutaneous coronary intervention (PCI) (top row) and PCI for acute myocardial infarction (AMI) (middle row).The bottom row displays the risk of mortality (percentage) in patients without AKI, corresponding to left column of top and middle rows; and odds ratios for mortality in patients with stage I AKI and stage II/III AKI compared with patients without AKI, corresponding to middle and right columns of top and middle rows. Results are displayed with 95% CI. Cr indicates creatinine.Among PCIs for AMI, the variation of adjusted OR of AKI for mortality across baseline SCr was significant for both stage I AKI (P=0.001) and stage II/III AKI (P<0.001). In patients with a baseline SCr of 1.0 mg/dL, the OR for mortality was 3.6 (95% CI, 3.2–4.1) in those with stage I AKI and 25.0 (95% CI, 20.3–30.8) for those with stage II/III AKI, compared with those without AKI. Whereas in patients with a baseline SCr of 4.0 mg/dL, the OR for mortality was 1.0 (95% CI, 0.4–2.6) for those with stage I AKI and 2.1 (95% CI, 0.5–8.4) for those with stage II/III AKI, compared with those without AKI.Our study, the first in a PCI population, finds a higher risk of mortality in stage II/III AKI than stage I AKI. More important, we found that the mortality risk associated with post‐PCI AKI varied nonlinearly across the range of baseline SCr. Patients with normal baseline renal function had a greater prognostic effect of AKI on mortality. This pattern was observed in both elective populations and populations with AMI and for mild and severe AKI. The reduction in prognostic impact of AKI with increasing baseline SCr appeared more pronounced for severe AKI than for mild AKI.Reasons for a lesser prognostic effect of AKI among those with elevated baseline SCr may be that a 0.3‐mg/dL increase in SCr represents a proportionally less severe reduction in estimated glomerular filtration rate in those with impaired renal function than among those with preserved function. Alternatively, the mechanisms of AKI may differ among those with and without preexisting chronic kidney disease. Additionally, greater test‐to‐test variation at higher SCr may add noise and affect the relationship of AKI with mortality among those with chronic kidney disease.Our study calls for caution while using binary post‐PCI AKI as a performance metric. Patients with normal renal function are affected more by AKI, whereas mild AKI does not confer additional mortality risk in patients with reduced renal function. Study limitations include lack of information on AKI subtype and coexistent conditions, which may affect AKI outcomes. Missing pre‐/post‐PCI SCr measurements may introduce selection bias. Nevertheless, this study is strengthened by the large number of patients and national representativeness of the NCDR registry.Sources of FundingThis publication was made possible by Clinical and Translational Science Awards grant number UL1 TR001863 from the National Center for Advancing Translational Science, a component of the National Institutes of Health. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health. The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the article; and decision to submit the article for publication.DisclosuresDr Murugiah received support from the National Heart, Lung, and Blood Institute of the National Institutes of Health (under award K08HL157727). Dr Wilson received support from the National Institute of Diabetes and Digestive and Kidney Disease (R01DK113191), the Agency for Health Research and Quality (R01HS027626), and from AstraZeneca, Whoop, and Vifor Pharma. Dr Masoudi previously had a contract with the American College of Cardiology as chief Scientific Advisor, National Cardiovascular Data Registry. Dr Messenger received institutional grant support from Philips Medical Systems and Medtronic for the University of Colorado School of Medicine. In the past 3 years, Harlan Krumholz received expenses and/or personal fees from UnitedHealth, Element Science, Eyedentifeye, and F‐Prime. He is a cofounder of Refactor Health and HugoHealth, and is associated with contracts, through Yale New Haven Hospital, from the Centers for Medicare & Medicaid Services and through Yale University from Janssen, Google, and Pfizer. The remaining authors have no disclosures to report.AcknowledgmentsChenxi Huang and Xin Xin had full access to all of the data in the study and take responsibility for the integrity of the data and accuracy of the data analysis. Concept and design: Jiun‐Ruey Hu, Karthik Murugiah, Harlan Krumholz, Chenxi Huang. Acquisition, analysis, or interpretation of data: Jiun‐Ruey Hu, Karthik Murugiah, Xin Xin, Mitsuaki Sawano, Harlan Krumholz, Chenxi Huang. Drafting of the article: Jiun‐Ruey Hu, Karthik Murugiah, Chenxi Huang. Critical revision of the article for important intellectual content: Jiun‐Ruey Hu, Karthik Murugiah, Mitsuaki Sawano, Yuan Lu, F. Perry Wilson, Frederick A. Masoudi, John C. Messenger, Harlan Krumholz, Chenxi Huang. Statistical analysis: Xin Xin, Chenxi Huang; Supervision: Harlan Krumholz, Chenxi Huang.Footnotes* Correspondence to: Chenxi Huang, PhD, Center for Outcomes Research and Evaluation, Yale‐New Haven Hospital, 195 Church Street, Sixth Floor, New Haven, CT 06510. Email: chenxi.huang@yale.eduThis article was sent to Ferhaan Ahmad, MD, PhD, Senior Associate Editor, for review by expert referees, editorial decision, and final disposition.For Sources of Funding and Disclosures, see page 3.References1 Rihal CS, Textor SC, Grill DE, Berger PB, Ting HH, Best PJ, Singh M, Bell MR, Barsness GW, Mathew V, et al. Incidence and prognostic importance of acute renal failure after percutaneous coronary intervention. Circulation. 2002; 105:2259–2264. doi: 10.1161/01.CIR.0000016043.87291.33LinkGoogle Scholar2 Brar SS, Aharonian V, Mansukhani P, Moore N, Shen AY, Jorgensen M, Dua A, Short L, Kane K. Haemodynamic‐guided fluid administration for the prevention of contrast‐induced acute kidney injury: the POSEIDON randomised controlled trial. Lancet. 2014; 383:1814–1823. doi: 10.1016/S0140-6736(14)60689-9CrossrefMedlineGoogle Scholar3 Tsai TT, Patel UD, Chang TI, Kennedy KF, Masoudi FA, Matheny ME, Kosiborod M, Amin AP, Messenger JC, Rumsfeld JS, et al. Contemporary incidence, predictors, and outcomes of acute kidney injury in patients undergoing percutaneous coronary interventions: insights from the NCDR CATH‐PCI registry. JACC Cardiovasc Interv. 2014; 7:1–9. doi: 10.1016/j.jcin.2013.06.016CrossrefMedlineGoogle Scholar4 Chui PW, Parzynski CS, Nallamothu BK, Masoudi FA, Krumholz HM, Curtis JP. Hospital performance on percutaneous coronary intervention process and outcomes measures. J Am Heart Assoc. 2017; 6:e004276. doi: 10.1161/JAHA.116.004276LinkGoogle Scholar5 Brennan JM, Curtis JP, Dai D, Fitzgerald S, Khandelwal AK, Spertus JA, Rao SV, Singh M, Shaw RE, Ho KK, et al. Enhanced mortality risk prediction with a focus on high‐risk percutaneous coronary intervention: results from 1,208,137 procedures in the NCDR (National Cardiovascular Data Registry). JACC Cardiovasc Interv. 2013; 6:790–799. doi: 10.1016/j.jcin.2013.03.020CrossrefMedlineGoogle Scholar eLetters(0)eLetters should relate to an article recently published in the journal and are not a forum for providing unpublished data. Comments are reviewed for appropriate use of tone and language. Comments are not peer-reviewed. Acceptable comments are posted to the journal website only. Comments are not published in an issue and are not indexed in PubMed. Comments should be no longer than 500 words and will only be posted online. References are limited to 10. 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Published on behalf of the American Heart Association, Inc., by Wiley BlackwellThis is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.https://doi.org/10.1161/JAHA.123.033649PMID: 38390832 Manuscript receivedNovember 22, 2023Manuscript acceptedJanuary 30, 2024Originally publishedFebruary 23, 2024 Keywordsacute kidney injurychronic kidney diseasecreatininemortalitypercutaneous coronary interventionPDF download SubjectsCatheter-Based Coronary and Valvular InterventionsComplicationsEpidemiologyMortality/SurvivalPercutaneous Coronary Intervention
BACKGROUND: Decreasing the amount of iodinated contrast is an important safety aspect of percutaneous coronary interventions (PCI), particularly in patients with a high risk of contrast-induced acute kidney injury (CI-AKI). Dynamic Coronary Roadmap (DCR) is a PCI navigation support tool projecting a motion-compensated virtual coronary roadmap overlay on fluoroscopy, potentially limiting the need for contrast during PCI. AIMS: This study investigates the contrast-sparing potential of DCR in PCI, compared to standard angiographic guidance. METHODS: The Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast) trial is a multicentre, international, prospective, unblinded, stratified 1:1 randomised controlled trial. Patients were randomised to either DCRguided PCI or to conventional angiography-guided PCI. The primary endpoint was the total volume of iodinated contrast administered, and the secondary endpoint was the number of cineangiography runs during PCI. RESULTS: The study population included 356 randomised patients (179 in DCR and 177 in control groups, respectively). There were no differences in patient demographics, angiographic characteristics or estimated glomerular filtration rate (eGFR) between the two groups. The total contrast volume used during PCI was significantly lower with DCR guidance compared with conventional angiographic guidance (64.6 +/- 44.4 ml vs 90.8 +/- 55.4 ml, respectively; p<0.001). The total number of cineangiography runs was also significantly reduced in the DCR group (8.7 +/- 4.7 vs 11.7 +/- 7.6 in the control group; p<0.001). CONCLUSIONS: Compared to conventional angiography-guided PCI, DCR guidance was associated with a significant reduction in both contrast volume and the number of cineangiography runs during PCI. (ClinicalTrials.gov: NCT04085614)
BACKGROUND: Cerebral embolic protection devices (EPDs) were developed to mitigate the risk of stroke during transcatheter aortic valve replacement (TAVR), but their benefit remains unproven. In the PROTECTED-TAVR trial (Stroke Protection With Sentinel During Transcatheter), EPD use did not reduce periprocedural stroke (primary study outcome) but led to a 62% reduction in the secondary end point of disabling stroke. Given these results, the impact of EPDs during TAVR remains unclear. METHODS: We used STS/ACC TVT registry data to examine the association between EPD use and a proxy for disabling stroke among transfemoral TAVR patients between January 2018 and June 2023. The primary outcome was in-hospital disabling stroke-defined as stroke associated with either in-hospital death or discharge to a nonhome location. We evaluated the association between EPD use and disabling stroke using instrumental variable analysis with a site-level preference for EPD use as the instrument-a quasi-experimental approach that can support causal inference. In addition, we performed a propensity score-based comparison using overlap weighting as a secondary analysis. RESULTS: The study population consisted of 414649 patients of whom 53389 (12.9%) received an EPD. The unadjusted rate of in-hospital disabling stroke was 0.7% among the EPD group and 0.9% in the no-EPD group. EPD use was associated with a reduction in disabling stroke in both instrumental variable analysis (relative risk, 0.87 [95% CI, 0.73-1.00]) and propensity-weighted analysis (odds ratio, 0.79 [95% CI, 0.70-0.90]) but was not associated with a reduction in nondisabling stroke. In subgroup analyses, the benefit of EPD was greater among those with versus without prior stroke (P-interaction<0.05 for both instrumental variable and propensity-weighted analyses). CONCLUSIONS: In the largest study to date, among patients undergoing TAVR, EPD use was associated with a small, borderline significant reduction in stroke associated with death or discharge to a nonhome location (a proxy for disabling stroke) that is likely to be causal in nature. Taken together with previous mechanistic and clinical studies, these findings provide credible evidence that EPDs benefit patients undergoing TAVR.
Background:Calcified coronary lesions are a challenge for percutaneous coronary interventions (PCIs). Coronary intravascular lithotripsy (IVL) is a novel calcium modification technology approved for commercial use in February 2021, but little is known about its uptake in US clinical practice. Methods:We described trends in use of calcium modification strategies, variation in use across hospitals, and predictors of calcium modification and IVL use in PCI. We included National Cardiovascular Data Registry CathPCI Registry patients who underwent PCI between April 1, 2018, and December 31, 2022. We examined trends and hospital variation in calcium modification and IVL use. We used multivariate hierarchical logistic regression to identify predictors of calcium modification and IVL use at hospitals in 2022. Results:Of 2,733,494 PCIs across 1676 hospitals over 4.75 years, 11.4% were performed with calcium modification. Coronary IVL use increased rapidly from 0% of PCIs in Q4 2020 to 7.8% of PCIs in Q4 2022, which was accompanied by an overall increase in use of all calcium modification strategies (11.1%-16.0%) during this period with a slight corresponding decrease in coronary atherectomy use (5.4%-4.4%). In 2022, there was wide variation in IVL use across hospitals (median, 3.86%; IQR, 0%-8.19%), with IVL being the most common calcium modification strategy in 48% of hospitals. The treating hospital was the strongest predictor of calcium modification (median odds ratio [OR], 2.49; 95% CI, 2.40-2.57) and IVL use (median OR, 2.89; 95% CI, 2.74-3.04). Conclusions:IVL has rapidly changed the landscape of calcium modification use for PCI, although there remains wide variation across hospitals.
The Society for Cardiovascular Angiography & Interventions (SCAI) endeavors to serve the interventional cardiology community, including both clinicians and patients. The SCAI Scientific Oversight Committee is charged with annually reviewing the scientific needs of the membership at large, including survey-based research of the practice patterns and perspectives of SCAI members and stakeholders. This document is intended as a reference by the survey proponents, document writing groups, external collaborators, SCAI representatives, peer reviewers, and anyone seeking information about the SCAI surveys program. The aims of this SCAI document are to: (1) provide a framework for members to develop survey requests that are relevant, feasible, and align with the Society’s missions and goals; (2) promote transparency and clarity for the process of performing a survey through SCAI; (3) establish the criteria for evaluating survey requests and provide input on reliable and meaningful design, data collection, and best practices; and (4) facilitate collaboration and communication between the survey committee and members of SCAI to maximize the impact of the findings to the interventional community at large.
Coronary interventions, and specifically the number of percutaneous coronary intervention (PCI) procedures, are increasing, together with their complexity. Contrast media administration during those procedures assists in visualising vessels anatomy, but also increases the risk of contrast-induced nephropathy (CIN), which remains one of the most common complications, and has been associated with poor clinical outcomes. Dynamic Coronary Roadmap (DCR) is a technology that creates a dynamic, motion-compensated, real-time view of the coronary anatomy overlaid on a 2D fluoroscopic image, creating a coloured map that adjusts automatically, and providing continuous visual feedback on the positioning of wires and catheters. The technology, which is already being used in clinical practice, has posed the promise of not only assisting in navigating wires and catheters, but also reducing the use of contrast during PCI. DCR4Contrast was a randomised clinical trial conducted in the USA, Europe, and Israel that enrolled more than 356 patients. The primary endpoint for the study was the reduction in contrast administered with the use of DCR, compared with the control group. The secondary endpoint was the potential reduction in the number of cineangiography runs. In the trial, DCR reduced the total contrast volume per PCI procedure by an average of 28.8%, and reduced the number of contrast-enhanced cineangiography runs per procedure by 26.3%. It was also demonstrated that the more complex the PCI procedure, the larger the reduction in contrast with DCR. Here, interventional cardiology experts discussed the need for contrast reduction, and the evidence for DCR.
Stent failure remains the major drawback to the use of coronary stents as a revascularization strategy. Recent advances in imaging have substantially improved our understanding of the mechanisms underlying these occurrences, which have in common numerous clinical risk factors and mechanical elements at the time of stent implantation. In-stent restenosis remains a common clinical problem despite numerous improvements in-stent design and polymer coatings over the past 2 decades. It generates significant health care cost and is associated with an increased risk of death and rehospitalization. Stent thrombosis causes abrupt closure of the stented artery and therefore carries a high risk of myocardial infarction and death. This Society for Cardiovascular Angiography & Interventions (SCAI) Expert Consensus Statement suggests updated practical algorithmic approaches to in-stent restenosis and stent thrombosis. A pragmatic outline of assessment and management of patients presenting with stent failure is presented. A new SCAI classification that is time-sensitive with mechanistic implications of in-stent restenosis is proposed. Emphasis is placed on frequent use of intracoronary imaging and assessment of timing to determine the precise etiology because that information is crucial to guide selection of the best treatment option. SCAI recommends image-guided coronary stenting at the time of initial implantation to minimize the occurrence of stent failure. When in-stent restenosis and stent thrombosis are encountered, imaging should be strongly considered to optimize the subsequent approach.
Dynamic Coronary Roadmap is a PCI navigation support tool which may potentially facilitate PCI and increase procedural safety by projecting a virtual coronary roadmap on the moving fluoroscopy, thus potentially decreasing the amount of contrast needed for PCI. While this has been FDA approved, evaluation of the quality of the roadmap for guiding simple and complex PCI has not been compared to standard PCI techniques in a real-world setting. The Dynamic Coronary Roadmap for Contrast Reduction trial (DCR4Contrast) is a multi-center, prospective, unblinded, stratified 1:1 randomized controlled trial investigating the use of Dynamic Coronary Roadmap, an automatic software tool integrated into the interventional X-ray system that provides the PCI operator with a real time, motion compensated dynamic overlay of the coronary tree on fluoroscopy. DCR4Contrast enrolled 371 patients undergoing PCI from six centers in the US and Europe. We will report the endpoint of roadmap quality as evaluated by the operators as well as the quality when used for single versus multivessel PCI. This is a placeholder as the enrollment was completed on 2023 Feb 09. Trial results will be available for presentation at SCAI 2023 for the Late Breaking Science session. Dynamic Coronary Roadmap has the potential to contribute to increased procedural safety by potentially reducing iodinated contrast utilization and radiation. Key to this is the quality of the roadmaps generated in the real-world setting. This is the first multi-center randomized assessment of the use of this medical device software developed to aid in the performance of PCI.