Background and Aims:Drug-coated balloons (DCBs) and drug-eluting stents (DESs) are commonly used in percutaneous coronary interventions (PCI), but their long-term comparative effectiveness remains unclear. This meta-analysis aimed to compare the clinical and angiographic outcomes of DCB versus DES in patients with in-stent restenosis (ISR) and de novo lesions, including ST-elevation myocardial infarction (STEMI) and small vessel disease (SVD). Methods:A systematic search identified randomized controlled trials (RCTs) comparing DCBs and DESs. The primary outcome was target lesion revascularization (TLR), with secondary outcomes including all-cause mortality, cardiovascular mortality, myocardial infarction, stent/lesion thrombosis, and late lumen loss (LLL). The frequentist network meta-analysis and binary random-effect analysis were used to compare DCB versus. DES. Results:A total of 21 RCTs with 4244 patients were included. In ISR patients, the risk of TLR was comparable between DCB vs. DES at 1-year (OR: 1.36, 95% CI: 0.86-2.14) and beyond 1-year (OR: 1.23, 95% CI: 0.79-1.93). DCB and DES showed no significant difference in other secondary outcomes at 1-year and beyond. In STEMI and SVD patients, DCB and DES demonstrated similar outcomes, except for a lower LLL after DCB in patients with SVD (SMD: -0.38, 95% CI: -0.53 to -0.22). Conclusion:DCB and DES were associated with a similar risk of TLR in patients with ISR, STEMI, and SVD. The results were consistent at 1-year and beyond time intervals. Furthermore, DCB was associated with a lower LLL compared to DES in patients with SVD.
Background Patients with coronary in-stent restenosis (ISR) within multiple layers of stent pose a specific clinical challenge because of higher rates of recurrent restenosis as well as a desire to avoid an additional layer of stent. Drug-coated balloons (DCBs) provide an alternative antiproliferative therapeutic option for multilayer ISR. Objectives We evaluated the efficacy and safety of a low-dose paclitaxel-coated vs uncoated balloon among patients with multilayer or single-layer ISR in the AGENT IDE (A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis) trial. Methods AGENT IDE is a prospective, multicenter trial that randomized patients with ISR (reference vessel diameter >2.0 mm to ≤4.0 mm and lesion length <26 mm) in a 2:1 allocation to paclitaxel-coated or an uncoated balloon following successful lesion preparation. Randomization was stratified by multi- vs single-layer ISR as well as by center. The primary study endpoint was 1-year target lesion failure (TLF): composite occurrence of ischemia-driven target lesion revascularization (TLR), target vessel-related myocardial infarction (MI), or cardiac death. Results Of the 600 patients randomized in the trial, multilayer ISR was present in 258 (44%) patients. Patients with multilayer ISR had higher rates of TLF at 1 year compared with those with single-layer ISR (29.0% vs 15.7%, P < 0.0001). The overall study results were consistent irrespective of multilayer vs single-layer ISR (Pinteraction = 0.66). Among patients with multilayer ISR, TLF was lower with paclitaxel-coated balloon compared with an uncoated balloon (23.8% vs 40.0%; HR: 0.55; 95% CI: 0.34-0.87; P = 0.01), driven by reductions in both TLR and target vessel-related MI. Similar findings were observed among patients with single layer ISR (1-year TLF: 13.5% with paclitaxel-coated vs 20.2% with uncoated balloon; HR: 0.64; 95% CI: 0.37-1.11; P = 0.11), although absolute event rates were lower. Conclusions Patients with ISR of multiple stent layers had higher rates of adverse stent-related events compared with patients with single-layer ISR. Treatment with a paclitaxel-coated balloon led to greater absolute risk reduction in 1-year TLF among patients with multilayer ISR compared with an uncoated balloon. (A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis [ISR] [AGENT IDE]; NCT04647253)
Cardiogenic shock (CS) remains a high-mortality condition that demands rapid diagnosis, coordinated multidisciplinary management, and timely initiation of mechanical circulatory support. As more institutions implement dedicated CS teams, substantial heterogeneity has emerged in how these teams are structured, activated, and sustained. To better characterize this variability and begin defining the components of an optimal CS team, the Society of Critical Care Cardiology (SoCCC), in partnership with the Society for Cardiovascular Angiography and Interventions (SCAI), convened the Inaugural Cardiogenic Shock Teams Think Tank. Held on October 17, 2024, as a preconference program to SCAI SHOCK 2024 in Washington, DC, the meeting brought together national leaders in CS care, mechanical circulatory support, and resuscitation to identify shared challenges and propose practical solutions. This manuscript summarizes key insights from this inaugural Think Tank, which represents the first in an ongoing series of collaborative efforts aimed at informing the standardization and optimization of CS teams nationwide. Specifically, we review the ideal composition and core competencies of a CS team; the rationale and emerging evidence supporting dedicated team-based CS care; activation algorithms and operational workflows; and common barriers to establishing and sustaining such teams. We also outline future directions and opportunities to strengthen collaborative infrastructure, refine clinical pathways, and enhance the reliability, responsiveness, and effectiveness of cardiogenic shock teams across diverse healthcare settings.
Interstitial lung disease (ILD) complicated by pulmonary hypertension (PH) is associated with poor outcomes. However, real-world data characterizing the hemodynamic profiles of ILD patients undergoing right heart catheterization (RHC) remain limited. We retrospectively analyzed ILD patients who underwent RHC between 2006 and 2024. Hemodynamic profiles were assessed according to the 5th, 6th, and 7th World Symposium on Pulmonary Hypertension (WSPH) definitions and for severe PH (pulmonary vascular resistance [PVR] > 5 Wood units). Correlations between pulmonary function testing (PFT) variables and PVR were explored, and baseline characteristics were compared across groups stratified by PH severity. There were 3541 ILD patients evaluated of whom 12.2% underwent RHC. Among 371 patients with available RHC data and pulmonary arterial wedge pressure (PAWP) ≤ 15 mmHg, 49.6%, 54.4%, and 69.4% met the 5th, 6th, and 7th WSPH criteria for precapillary PH, respectively, while 31.3% exhibited severe PH. Correlations between diffusing capacity for carbon monoxide (DLco)%, and forced vital capacity (FVC)%/DLco% ratio with PVR were weak. Our findings highlight the heterogeneous hemodynamic landscape of ILD-PH in clinical practice and underscore the need for heightened vigilance and lower thresholds for RHC. These real-world data can inform future clinical trial design, screening strategies, and management decisions for ILD-PH.
BACKGROUND AND AIMS:Calcific coronary lesions pose significant challenges to percutaneous coronary intervention (PCI), limiting stent delivery and expansion. Intravascular lithotripsy (IVL) and rotational atherectomy (RA) are widely used plaque modification techniques; however, comparative data on their effectiveness remain limited. We aimed to compare clinical and procedural outcomes between IVL and RA in the management of calcific coronary lesions. METHODS:PubMed, Embase, Scopus, and Cochrane Library were searched through January 2025 for randomized controlled trials (RCTs) and observational studies comparing IVL with RA in calcific coronary lesions undergoing PCI. The primary outcome was major adverse cardiovascular events (MACE). Secondary outcomes included all-cause mortality, myocardial infarction (MI), stroke, repeat revascularization, procedural outcomes, and minimum stent area (MSA). Random-effect models were used for outcome analysis, and meta-regression assessed the impact of baseline characteristics. RESULTS:A total of 14 studies (2 RCTs, 12 observational; 2056 IVL patients, 3099 RA patients) were included. IVL and RA showed a comparable risk of MACE (OR 0.81; 95% CI 0.57-1.16; p: 0.26) and similar risks of all-cause mortality, MI, stroke, and repeat revascularization. IVL was associated with a lower risk of coronary perforation (OR 0.43; 95% CI 0.32-0.57; p < 0.001) and slow or no-reflow (OR 0.34; 95% CI 0.14-0.79; p 0.02). Additionally, IVL resulted in shorter procedure duration (SMD -0.30; 95% CI -0.61-0.00; p 0.05) and fluoroscopy time (SMD -0.41; 95% CI -0.62, -0.20; p 0.004). Post-procedural MSA was similar between IVL and RA. CONCLUSION:IVL and RA demonstrated comparable efficacy in terms of MACE and clinical outcomes in patients with calcific coronary lesions undergoing PCI. However, IVL was associated with a lower risk of coronary perforation, slow or no-reflow phenomenon, and reduced procedure duration and fluoroscopy time, suggesting a potential procedural advantage over RA.
BACKGROUND:Managing coronary chronic total occlusion (CTO) in older adults remains challenging due to a scarcity of evidence. OBJECTIVES:We aimed to assess the association of attempted/successful CTO percutaneous coronary intervention (CTO-PCI) with quality of life (QoL) measures, all-cause mortality, and cardiovascular outcomes in studies that adequately represented older adults. METHODS:A systematic search of 6 databases was performed to identify randomized trials and observational studies comparing CTO-PCI with optimal medical therapy (OMT) in adults, with particular inclusion of studies adequately representing older individuals. Meta-regression analyses were conducted to estimate relative risks (RRs) for key outcomes. RESULTS:A total 29 studies encompassing 19,282 patients were included, of which 28 were observational. Compared with OMT, attempted CTO-PCI was significantly associated with reductions in cardiac death (RR: 0.55; 95% CI: 0.40-0.76), all-cause mortality (RR: 0.61; 95% CI: 0.50-0.75), and major adverse cardiovascular events (RR: 0.68; 95% CI: 0.60-0.78). Rates of myocardial infarction and revascularization were similar between groups. In analyses comparing successful vs failed CTO-PCI, only cardiac death and all-cause mortality were reduced. In addition, among the 4 studies that evaluated QoL, attempted/successful CTO-PCI yielded greater improvements than OMT/failed PCI. Evidence for the above results were derived from observational studies and remained less certain. CONCLUSIONS:In older adults, attempted or successful CTO-PCI may be associated with improved QoL and favorable cardiovascular outcomes compared with OMT; however, as these findings are largely derived from observational studies, they should be viewed as hypothesis-generating. Randomized trials in representative older populations are needed to confirm these associations.
Coronary chronic total occlusions (CTO) are present in up to one-third of patients with coronary artery disease (CAD). It is thus essential for all clinical cardiologists to possess a basic awareness and understanding of CTOs, including optimal evaluation and management. While percutaneous coronary intervention (PCI) for CTO lesions has many similarities to non-CTO PCI, there are important considerations pertaining to pre-procedural evaluation, interventional techniques, procedural complications, and post-procedure management and follow-up unique to patients undergoing this highly specialized intervention. Distinct from other existing topical reviews, the current manuscript focuses on key knowledge relevant to non-interventional cardiologists.
BACKGROUND: Cardiogenic shock (CS) mortality remains near 40%. In addition to inadequate cardiac output, patients with severe CS may exhibit vasodilation. We aimed to examine the prevalence and consequences of vasodilation in CS. METHODS: We analyzed all patients hospitalized at a CS referral center who were diagnosed with CS stages B to E and did not have concurrent sepsis or recent cardiac surgery. Vasodilation was defined by lower systemic vascular resistance (SVR), higher norepinephrine equivalent dose, or a blunted SVR response to pressors. Threshold SVR values were determined by their relation to 14-day mortality in spline models. The primary outcome was death within 14 days of CS onset in multivariable-adjusted Cox models. RESULTS: This study included 713 patients with a mean age of 60 years and 27% females; 14-day mortality was 28%, and 38% were vasodilated. The median SVR was 1308 dynes center dot s center dot cm(-5) (interquartile range, 870-1652), median norepinephrine equivalent was 0.11 mu g/kg per minute (interquartile range, 0-0.2), and 28% had a blunted pressor response. Each 100-dynes center dot s center dot cm(-5) decrease in SVR below 800 was associated with 20% higher mortality (adjusted hazard ratio, 1.23; P=0.004). Each 0.1-mu g/kg per minute increase in norepinephrine equivalent dose was associated with 15% higher mortality (adjusted hazard ratio, 1.12; P<0.001). A blunted pressor response was associated with a nearly 2-fold mortality increase (adjusted hazard ratio, 1.74; P=0.003). CONCLUSIONS: Pathophysiologic vasodilation is prevalent in CS and independently associated with an increased risk of death. CS vasodilation can be identified by SVR <800 dynes center dot s center dot cm(-5), high doses of pressors, or a blunted SVR response to pressors. Additional studies exploring mechanisms and treatments for CS vasodilation are needed.
Cardiogenic shock (CS) is a time-sensitive and hemodynamically complex syndrome with a broad spectrum of etiologies and clinical presentations. Despite contemporary therapies, CS continues to maintain high morbidity and mortality ranging from 35 to 50%. More recently, burgeoning observational research in this field aimed at enhancing the early recognition and characterization of the shock state through standardized team-based protocols, comprehensive hemodynamic profiling, and tailored and selective utilization of temporary mechanical circulatory support devices has been associated with improved outcomes. In this narrative review, we discuss the pathophysiology of CS, novel phenotypes, evolving definitions and staging systems, currently available pharmacologic and device-based therapies, standardized, team-based management protocols, and regionalized systems-of-care aimed at improving shock outcomes. We also explore opportunities for fertile investigation through randomized and non-randomized studies to address the prevailing knowledge gaps that will be critical to improving long-term outcomes.
Racial, Ethnic, Socioeconomic, and Geographic Inequities in Access to Mechanical Circulatory SupportJournal of the Society for Cardiovascular Angiography & Interventions101193PreviewHospital admissions for cardiogenic shock have increased in the United States. Temporary mechanical circulatory support (tMCS) can be used to acutely stabilize patients. We sought to evaluate the presence of racial, ethnic, and socioeconomic inequities in access to MCS in the United States among patients with cardiogenic shock. Full-Text PDF Open Access With advances in primary percutaneous coronary intervention and the integration of regionalized systems of care networks, in-hospital mortality following acute myocardial infarction (AMI) has dropped to <5%1McNamara R.L. Kennedy K.F. Cohen D.J. et al.Predicting in-hospital mortality in patients with acute myocardial infarction.J Am Coll Cardiol. 2016; 68: 626-635https://doi.org/10.1016/j.jacc.2016.05.049Crossref PubMed Scopus (158) Google Scholar; however, in the 5% to 12% of AMI complicated by circulatory collapse due to cardiogenic shock (CS), short-term mortality rates remain >40%.2Hochman J.S. Sleeper L.A. Webb J.G. et al.Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK investigators. Should we emergently revascularize occluded coronaries for cardiogenic shock.N Engl J Med. 1999; 341: 625-634https://doi.org/10.1056/NEJM199908263410901Crossref PubMed Scopus (2377) Google Scholar, 3Kolte D. Khera S. Aronow W.S. et al.Trends in incidence, management, and outcomes of cardiogenic shock complicating ST-elevation myocardial infarction in the United States.J Am Heart Assoc. 2014; 3e000590https://doi.org/10.1161/JAHA.113.000590Crossref Scopus (420) Google Scholar, 4Sterling L.H. Fernando S.M. Talarico R. et al.Long-term outcomes of cardiogenic shock complicating myocardial infarction.J Am Coll Cardiol. 2023; 82: 985-995https://doi.org/10.1016/j.jacc.2023.06.026Crossref Scopus (1) Google Scholar In response to these discouraging outcomes, an increasing number of patients with CS due to AMI or acutely decompensated heart failure undergo implantation of temporizing mechanical circulatory support (tMCS) devices to support hemodynamics and end-organ perfusion as a bridge to myocardial recovery or advanced cardiac replacement therapies.5Shah M. Patnaik S. Patel B. et al.Trends in mechanical circulatory support use and hospital mortality among patients with acute myocardial infarction and non-infarction related cardiogenic shock in the United States.Clin Res Cardiol. 2018; 107: 287-303https://doi.org/10.1007/s00392-017-1182-2Crossref PubMed Scopus (182) Google Scholar,6Schrage B. Becher P.M. Goßling A. et al.Temporal trends in incidence, causes, use of mechanical circulatory support and mortality in cardiogenic shock.ESC Heart Fail. 2021; 8: 1295-1303https://doi.org/10.1002/ehf2.13202Crossref PubMed Scopus (42) Google Scholar More recently, this surge in CS device-based therapy has been fueled by an increase in the deployment of microaxial left ventricular assist devices (mLVAD) and extracorporeal membrane oxygenation (ECMO), given their enhanced hemometabolic support capabilities compared with conventional intraaortic balloon pump (IABP).7Thiele H. Jobs A. Ouweneel D.M. et al.Percutaneous short-term active mechanical support devices in cardiogenic shock: a systematic review and collaborative meta-analysis of randomized trials.Eur Heart J. 2017; 38: 3523-3531https://doi.org/10.1093/eurheartj/ehx363Crossref PubMed Scopus (238) Google Scholar, 8Amin A.P. Spertus J.A. Curtis J.P. et al.The evolving landscape of Impella use in the United States among patients undergoing percutaneous coronary intervention with mechanical circulatory support.Circulation. 2020; 141: 273-284https://doi.org/10.1161/CIRCULATIONAHA.119.044007Crossref PubMed Scopus (242) Google Scholar, 9Syed M. Khan M.Z. Osman M. et al.Sixteen-year national trends in use and outcomes of VA-ECMO in cardiogenic shock.Cardiovasc Revasc Med. 2022; 44: 1-7https://doi.org/10.1016/j.carrev.2022.06.267Crossref Scopus (6) Google Scholar This trend continues despite an absence of randomized clinical trial (RCT) data demonstrating improvement in short-term survival with tMCS devices compared with medical therapy or IABP, and with clinical guidelines assigning their routine use in AMI-CS only a Class IIb (Level of Evidence: C) recommendation.10Karami M. Eriksen E. Ouweneel D.M. et al.Long-term 5-year outcome of the randomized IMPRESS in severe shock trial: percutaneous mechanical circulatory support vs. intra-aortic balloon pump in cardiogenic shock after acute myocardial infarction.Eur Heart J Acute Cardiovasc Care. 2021; 10: 1009-1015https://doi.org/10.1093/ehjacc/zuab060Crossref PubMed Scopus (24) Google Scholar, 11Thiele H. Zeymer U. Akin I. et al.Extracorporeal life support in infarct-related cardiogenic shock.N Engl J Med. 2023; 389: 1286-1297https://doi.org/10.1056/NEJMoa2307227Crossref Google Scholar, 12Levine G.N. Bates E.R. Blankenship J.C. et al.ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients with ST-elevation myocardial infarction: an update of the 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention and the 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction.Circulation. 2016; 133: 1135-1147https://doi.org/10.1161/CIR.0000000000000336Crossref PubMed Scopus (339) Google Scholar Perhaps, the increased use of tMCS devices is fueled by data from dedicated North American CS registries that show that the early use of hemodynamically tailored tMCS at institutions with appropriate levels of expertise is associated with improved survival.13Basir M.B. Kapur N.K. Patel K. et al.Improved outcomes associated with the use of shock protocols: updates from the national cardiogenic shock initiative.Catheter Cardiovasc Interv. 2019; 93: 1173-1183https://doi.org/10.1002/ccd.28307Crossref PubMed Scopus (271) Google Scholar, 14Tehrani B.N. Truesdell A.G. Sherwood M.W. et al.Standardized team-based care for cardiogenic shock.J Am Coll Cardiol. 2019; 73: 1659-1669https://doi.org/10.1016/j.jacc.2018.12.084Crossref PubMed Scopus (277) Google Scholar, 15Papolos A.I. Kenigsberg B.B. Berg D.D. et al.Management and outcomes of cardiogenic shock in cardiac ICUs with versus without shock teams.J Am Coll Cardiol. 2021; 78: 1309-1317https://doi.org/10.1016/j.jacc.2021.07.044Crossref PubMed Scopus (62) Google Scholar To muddy the waters in this field even further, there is marked regional variation in the expertise, access to, and use of tMCS devices for CS patients who remain unresponsive to conventional treatment strategies.8Amin A.P. Spertus J.A. Curtis J.P. et al.The evolving landscape of Impella use in the United States among patients undergoing percutaneous coronary intervention with mechanical circulatory support.Circulation. 2020; 141: 273-284https://doi.org/10.1161/CIRCULATIONAHA.119.044007Crossref PubMed Scopus (242) Google Scholar,16Shaefi S. O’gara B. Kociol R.D. et al.Effect of cardiogenic shock hospital volume on mortality in patients with cardiogenic shock.J Am Heart Assoc. 2015; 4e001462https://doi.org/10.1161/JAHA.114.001462Crossref Scopus (120) Google Scholar, 17Geller B.J. Sinha S.S. Kapur N.K. et al.Escalating and de-escalating temporary mechanical circulatory support in cardiogenic shock: a scientific statement from the American Heart Association.Circulation. 2022; 146: e50-e68https://doi.org/10.1161/CIR.0000000000001076Crossref PubMed Scopus (35) Google Scholar, 18Elbadawi A. Elgendy I.Y. Omer M.A. et al.Hospital volume and in-hospital outcomes with Impella guided percutaneous coronary interventions: insights from a national database.Am J Cardiol. 2020; 125: 1753-1754https://doi.org/10.1016/j.amjcard.2020.03.007Abstract Full Text Full Text PDF Scopus (2) Google Scholar How tMCS use is influenced by patient demographic characteristics, such as race, ethnicity, and social determinants of health has not been well studied. In this issue of JSCAI, Nathan et al19Nathan A.S. Reddy K.P. Eberly L.A. et al.Racial, ethnic, socioeconomic, and geographic inequities in access to mechanical circulatory support.J Soc Cardiovasc Angiogr Interv. 2023; Google Scholar examined racial, ethnic, and socioeconomic disparities in access to tMCS in Medicare beneficiaries with an admission or diagnosis discharge of CS who were treated with IABP, mLVAD, or ECMO at 1829 percutaneous coronary intervention-capable acute care facilities at the 25 largest core-based statistical areas in the United States. These authors should be commended for performing an in-depth analysis that provides insight into this device-related health care disparity. Using Medicare demographic characteristics to identify race and ethnicity, and individual assessments of median household income, Medicaid dual-eligibility, and distressed community index scores to categorize socioeconomic status, the authors (1) compared patient socioeconomic and hospital characteristics of institutions with and without mLVAD or ECMO programs; (2) determined the likelihood of mLVAD or ECMO use based on race, ethnicity, and socioeconomic status; and (3) described variations in ZIP code-level age-adjusted rates of mLVAD utilization. The findings were sobering; widespread disparities in access to these cutting-edge therapies were observed based on race and ethnicity. More than 90% of sites with mLVAD and ECMO programs were located in metropolitan areas, and these hospitals were more likely to treat patients with high median household incomes. Only 3 centers with mLVAD and 1 with ECMO capabilities were identified in rural areas. Racial and ethnic disparities were equally stark, with <10% of all patients receiving an mLVAD self-identifying as African American. Using generalized linear mixed effects models, they elucidated associations between socioeconomic status, race, ethnicity, and the likelihood of receiving an mLVAD. African American and dual Medicaid-eligible CS patients were at significant disadvantages, with the odds of receiving these advanced device-based treatment strategies reduced by 37% and 20%, respectively. More pronounced findings were noted with ECMO, such that for each $1000 decrement in median household income there was a 35% reduction in the likelihood of receiving this form of cardiopulmonary support. Again, African Americans and dual Medicaid eligible patients fared most poorly, as their odds of undergoing cannulation for refractory circulatory collapse were reduced by 36% and 62%, respectively. Chloropleth maps of the core-based statistical areas in question graphically reinforced these study findings by demonstrating that African Americans, Hispanics, and patients who were dual Medicaid eligible had markedly attenuated rates of implantation of these devices. There is precedent for demographic and geographic variations in access to cutting-edge technologies across the spectrum of interventional cardiology.20Damluji A.A. Fabbro M. Epstein R.H. et al.Transcatheter aortic valve replacement in low-population density areas: assessing healthcare access for older adults with severe aortic stenosis.Circ Cardiovasc Qual Outcomes. 2020; 13e006245https://doi.org/10.1161/CIRCOUTCOMES.119.006245Crossref Scopus (11) Google Scholar, 21Steitieh D. Zaidi A. Xu S. et al.Racial disparities in access to high-volume mitral valve transcatheter edge-to-edge repair centers.J Soc Cardiovasc Angiogr Interv. 2022; 1100398https://doi.org/10.1016/j.jscai.2022.100398Abstract Full Text Full Text PDF Scopus (2) Google Scholar, 22Kupsky D.F. Wang D.D. Eng M. et al.Socioeconomic disparities in access for watchman device insertion in patients with atrial fibrillation and at elevated risk of bleeding.Struct Heart. 2019; 3: 144-149https://doi.org/10.1080/24748706.2019.1569795Abstract Full Text Full Text PDF Google Scholar, 23Maknojia A. Gilani A. Ghatak A. Racial disparity in patients with chronic coronary total occlusion undergoing interventions.J Soc Cardiovasc Angiogr Interv. 2022; 1: E-21Google Scholar Using health care administrative inpatient claims data, Damluji et al20Damluji A.A. Fabbro M. Epstein R.H. et al.Transcatheter aortic valve replacement in low-population density areas: assessing healthcare access for older adults with severe aortic stenosis.Circ Cardiovasc Qual Outcomes. 2020; 13e006245https://doi.org/10.1161/CIRCOUTCOMES.119.006245Crossref Scopus (11) Google Scholar reported a nearly 7-fold difference in transcatheter aortic valve replacement utilization rates in the state of Florida, with the majority of dedicated valve centers located in high population density areas, and those residing in low population density areas having marked increases in travel time/distance and >6 fold higher procedural mortality. Parallel findings were noted in a contemporary analysis of 1567 hospital discharges following transcatheter edge-to-edge repair for severe mitral valve regurgitation from the Arizona, Colorado, Florida, Maryland, North Carolina, New Jersey, New York, and Virginia State Inpatient Databases. Specifically, there were significant racial disparities in access to high-volume mitral valve institutions, with African Americans and Hispanics being afforded 59% and 51% lower chances of access to transcatheter mitral valve repair at high-volume centers, respectively.21Steitieh D. Zaidi A. Xu S. et al.Racial disparities in access to high-volume mitral valve transcatheter edge-to-edge repair centers.J Soc Cardiovasc Angiogr Interv. 2022; 1100398https://doi.org/10.1016/j.jscai.2022.100398Abstract Full Text Full Text PDF Scopus (2) Google Scholar Hispanics were also 3 times more likely to experience in-hospital mortality post-procedure.21Steitieh D. Zaidi A. Xu S. et al.Racial disparities in access to high-volume mitral valve transcatheter edge-to-edge repair centers.J Soc Cardiovasc Angiogr Interv. 2022; 1100398https://doi.org/10.1016/j.jscai.2022.100398Abstract Full Text Full Text PDF Scopus (2) Google Scholar Unlike valve therapies, tMCS devices have not been associated with improved survival, and they are often implanted under emergency circumstances, in which the rates of major bleeding complications and acute limb ischemia may be as high as 40%.24Pahuja M. Ranka S. Chehab O. et al.Incidence and clinical outcomes of bleeding complications and acute limb ischemia in STEMI and cardiogenic shock.Catheter Cardiovasc Interv. 2021; 97: 1129-1138https://doi.org/10.1002/ccd.29003Crossref PubMed Scopus (26) Google Scholar, 25Cheng R. Hachamovitch R. Kittleson M. et al.Complications of extracorporeal membrane oxygenation for treatment of cardiogenic shock and cardiac arrest: a meta-analysis of 1,866 adult patients.Ann Thorac Surg. 2014; 97: 610-616https://doi.org/10.1016/j.athoracsur.2013.09.008Abstract Full Text Full Text PDF PubMed Scopus (610) Google Scholar, 26Stone G.W. Abraham W.T. Lindenfeld J. et al.Five-year follow-up after transcatheter repair of secondary mitral regurgitation.N Engl J Med. 2023; 388: 2037-2048https://doi.org/10.1056/NEJMoa2300213Crossref PubMed Scopus (30) Google Scholar, 27Mack M.J. Leon M.B. Thourani V.H. et al.Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients.N Engl J Med. 2019; 380: 1695-1705https://doi.org/10.1056/NEJMoa1814052Crossref PubMed Scopus (2900) Google Scholar There exist well-established relationships between volume and outcomes in CS.16Shaefi S. O’gara B. Kociol R.D. et al.Effect of cardiogenic shock hospital volume on mortality in patients with cardiogenic shock.J Am Heart Assoc. 2015; 4e001462https://doi.org/10.1161/JAHA.114.001462Crossref Scopus (120) Google Scholar Therefore, another unwanted impact of the low use of tMCS devices in nonmetropolitan hospitals is that these facilities may experience worse outcomes and higher complication rates with the infrequent use of devices. In the context of recent observational data suggesting the potential for improved outcomes when tMCS devices are implanted using standardized team-based protocols, one may argue that the demographic and geographic differences in outcomes with CS seen today are in part due to the nonuniform patterns of patient selection seen in real-world clinical practice.13Basir M.B. Kapur N.K. Patel K. et al.Improved outcomes associated with the use of shock protocols: updates from the national cardiogenic shock initiative.Catheter Cardiovasc Interv. 2019; 93: 1173-1183https://doi.org/10.1002/ccd.28307Crossref PubMed Scopus (271) Google Scholar Notwithstanding the absence of professional societal guideline support for the broad use of tMCS devices in CS, the findings of Nathan et al highlight pervasive racial and ethnic barriers to the use of advanced medical device therapies present in the US health care system. These inequities have historically and disproportionately affected segments of our society who not only have the greatest burden of health and social risk factors but who are also underrepresented in clinical trials and whose voices are often not heard28Caraballo C. Ndumele C.D. Roy B. et al.Trends in racial and ethnic disparities in barriers to timely medical care among adults in the US, 1999 to 2018.JAMA Health Forum. 2022; 10 (3)e223856https://doi.org/10.1001/jamahealthforum.2022.3856Crossref Scopus (7) Google Scholar, 29Epps K. Goel R. Mehran R. et al.Influence of race/ethnicity and sex on coronary stent outcomes in diabetic patients.J Soc Cardiovasc Angiogr Interv. 2023; 2https://doi.org/10.1016/j.jscai.2023.101053Abstract Full Text Full Text PDF Scopus (1) Google Scholar, 30Ortega R.F. Yancy C.W. Mehran R. Batchelor W. Overcoming lack of diversity in cardiovascular clinical trials: a new challenge and strategies for success.Circulation. 2019; 140: 1690-1692https://doi.org/10.1161/CIRCULATIONAHA.119.041728Crossref PubMed Scopus (33) Google Scholar within the cacophony of health care discussions. In the case of tMCS, further research is needed in the form of pragmatic and adequately powered RCT enriched with broad patient subsets and prespecified definitions and protocols. Coupled with multicenter collaborations such as the American Heart Association’s Cardiogenic Shock Registry31Cardiogenic Shock Registryhttps://www.heart.org/en/professional/quality-improvement/cardiogenic-shock-registryDate accessed: October 12, 2023Google Scholar and regionalized shock networks, these efforts may provide further insight into the utilization and outcomes associated with advanced device-based interventions for CS across race, ethnicity, sex, rurality, and socioeconomic status. However, at their core, the findings of Nathan et al are disturbingly emblematic of a much more complex and challenging sociopolitical problem that is deeply rooted in the world’s richest health care system. Therefore, to truly level the “device therapy playing field” will require not only more targeted health-related outcomes research but a national commitment to improve health care access and quality, in general, and especially for those most in need of acute lifesaving therapies. Behnam Tehrani has received research grant funding support from Boston Scientific, and he is an advisor to Abbott Medical. Kelly Epps has no disclosures. Wayne Batchelor has served as a consultant for Boston Scientific, Abbott, Medtronic, and V-Wave. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Background: Coronary in-stent restenosis (ISR) secondary to neointimal hyperplasia or neoatherosclerosis remains a significant challenge following percutaneous coronary interventions (PCI), with no consensus on the optimal revascularization strategy. We compared the outcome of PCI for ISR using drug-coated balloons (DCB) and drug-eluting stents (DES) and investigated the time trends in their clinical outcomes. Methods: PubMed, Embase, Scopus, and the Cochrane Library databases were searched through May 2024. We included randomized controlled trials (RCTs) comparing DCB versus DES among patients with coronary ISR. The primary outcome was target lesion revascularization (TLR). Secondary outcomes included all-cause mortality, myocardial infarction (MI), stent thrombosis, and late lumen loss (LLL). Random-effects models were employed to analyze outcomes within 1-year and beyond 1-year intervals. Meta-regression analysis was used to investigate the effect of age, sex, history of diabetes, hypertension, dyslipidemia, smoking, and ejection fraction on all outcomes by applying mixed-effect models. Results: We included 10 RCTs (1034 patients in the DCB group and 943 patients in the DES group). We found similar incidence of 1-year TLR (odds ratio [OR] 1.36; 95% confidence interval [CI] 0.86, 2.14; P 0.194; I 2 43.3%) and >1-year TLR (OR 0.94; 95% CI 0.57, 1.56; P 0.817; I 2 0%) with the use of DCB versus DES. The risks of all-cause mortality, MI, and stent thrombosis were comparable between DCB and DES in 1-year and beyond 1-year follow-ups. At 6-9 months angiographic follow-up, DCB was associated with non-significantly lower LLL compared to DES (standardized mean difference [SMD] -0.12 millimeters; 95% CI -0.29, 0.05; P 0.170; I 2 71.7%). Meta-regression indicated that higher prevalence of diabetes was associated with an increased risk of 1-year revascularization after DCB compared to DES (Estimate 0.07; P 0.003; I 2 0%). Additionally, male sex was associated with an increased LLL in DCB versus DES (Estimate 0.034; P 0.001; I 2 41.8%). No association was found between other baseline characteristics and measured clinical outcomes. Conclusion: DCB demonstrated comparable PCI outcomes compared to DES in patients with coronary ISR.
Genotype based personalized antiplatelet therapy in the setting of percutaneous coronary intervention (PCI) has been studied in clinical trials. Despite the demonstrated risk associated with CYP2C19 loss-of-function ( LoF ) carriage in clopidogrel-treated PCI patients, real-world implementation of genotyping for PCI has been low. The goal of the current study was to provide CYP2C19 genotype information to the interventionalist prior to the completion of the catheterization to facilitate immediate personalized antiplatelet therapy. Routine personalization of P2Y 12 inhibitor therapy for PCI in a community hospital cardiac catheterization laboratory by POC genotyping with the SpartanRx system was first offered in February 2017. A best practice advisory (BPA) based on the Clinical Pharmacogenetics Implementation Consortium Guideline for CYP2C19 genotype and clopidogrel therapy was placed in the electronic health record prescription medication ordering system. By December 2019, 1,052 patients had CYP2C19 genotype testing, 429 patients underwent PCI with genotype guided antiplatelet therapy, and 250 patients underwent PCI without genotype testing and received antiplatelet therapy at the discretion of the treating physician. BPA compliance was 93. 87% of LoF allele carriers were prescribed ticagrelor or prasugrel whereas 96% of non- LoF allele carriers were prescribed clopidogrel. The genotyping results were available within 1 h and made immediately available for decision making by the interventional cardiologist. POC CYP2C19 genotyping is feasible in a community hospital catheterization laboratory and is associated with high rate of best practice compliance. Clinical Trial Registration : https://clinicaltrials.gov/ct2/show/NCT03040622
Medical therapy, including antianginal treatment, is the cornerstone in the management of stable ischemic heart disease (SIHD). However, it remains unclear whether combining antianginal agents provides benefits beyond monotherapy in terms of quality of life (QoL) and cardiovascular outcomes. We used data from the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial, which compared cardiovascular and QoL outcomes in patients with SIHD and diabetes mellitus randomized to revascularization with intensive medical therapy or intensive medical therapy alone. We categorized patients into 3 groups: ≥2 versus 1 versus 0 antianginals. We compared patient characteristics, QoL metrics, and cardiovascular end points at baseline and at 5 years, creating a multivariable model to adjust for key clinical confounders. Of 2,368 patients, 348 patients (14.7%) were on 0 antianginals, 1,020 patients (43.1%) were on 1 antianginal, and 1,000 patients (42.2%) were on ≥2 antianginals at baseline. The most common antianginal class was β blockers. At baseline, patients on 0 antianginals had better QoL metrics (self-health score, Duke activity status index, and energy rating) than patients on ≥2 antianginals. However, at the 1-year follow-up, patients taking only 1 antianginal showed greater QoL improvement than those taking 0 antianginal, without any incremental benefit in QoL metrics seen in patients taking ≥2 antianginal agents, even after adjusting for multiple covariates such as age, heart failure, diabetes control, and myocardial jeopardy index. Lastly, at the 5-year follow-up, after adjustment, there were no differences in all-cause mortality, major adverse cardiovascular events, or myocardial infarction between patients taking different numbers of antianginals. Adults on a single antianginal for SIHD and diabetes mellitus had similar or better improvements in QoL than those on 2 or more antianginal agents at 1 year of follow-up. These findings merit further research to better understand the impact of medical therapy intensity on QoL in patients with SIHD and associated co-morbidities.
Background:Right heart catheterization (RHC) is the gold standard for diagnosing pulmonary hypertension (PH) in patients with interstitial lung disease (ILD). However, discrepancies between pulmonary arterial wedge pressure (PAWP) and left ventricular end-diastolic pressure (LVEDP) remain understudied in this population. Methods:We conducted a retrospective analysis of data from ILD patients who underwent RHC and had concomitant LVEDP measurements. Pulmonary vascular resistance (PVR) was calculated using both PAWP and LVEDP. Patients were categorized based on PAWP and LVEDP values using a threshold of 15 mm Hg and PVR values using a threshold of 2 or 3 Wood Units. After that patients were categorized as concordant or discordant if both values were on the same or opposite sides of these thresholds, respectively. A discordantly higher PAWP group (left atrial dysfunction, LAD) was defined as patients with a PAWP-LVEDP difference of more than 3 mm Hg. Results:Among 87 ILD patients, 9 patients (10.3%) showed discordance between PAWP and LVEDP. LAD was observed in 12 patients (13.8%) and was associated with lower forced vital capacity (Odd ratio [OR]: 0.956, p = 0.049) and a larger left atrium diameter (OR: 3.205, p = 0.033). Discordance in PVR values was also noted, with potential treatment targets for PH-specific therapy differing in 9 patients (22.0%) depending on whether PAWP or LVEDP was used. Conclusions:This study highlights the clinical significance of PAWP-LVEDP discrepancies in suspected PH-ILD patients, emphasizing the need for comprehensive assessments incorporating LVEDP and clinical context for accurate diagnosis, risk stratification, and treatment decisions.
Background Distal transradial access (dTRA) is an alternative to conventional forearm transradial access (fTRA) for coronary angiography (CAG). Differences in healing of the radial artery (RA) in the forearm have not been evaluated between these 2 access strategies. We sought to compare the mean difference in forearm RA intimal‐medial thickening (IMT) in patients randomized to dTRA versus fTRA. Methods and Results In this single‐center randomized clinical trial, 64 patients undergoing nonemergent CAG were randomized (1:1) to dTRA versus fTRA. Ultra–high‐resolution (55‐MHz) vascular ultrasound of the forearm and distal RA was performed pre‐CAG and at 90 days. The primary end point was the mean change in forearm RA IMT. Secondary end points included procedural characteristics, vascular injury, RA occlusion, and ipsilateral hand pain and function. Baseline demographics and clinical characteristics, mean forearm RA IMT, and procedural specifics were similar between the dTRA and fTRA cohorts. There was no difference in mean change in forearm RA IMT between the 2 cohorts (0.07 versus 0.07 mm; P=0.37). No RA occlusions or signs of major vascular injury were observed at 90 days. Ipsilateral hand pain and function (Borg pain scale score: 12 versus 11; P=0.24; Disabilities of the Arm, Shoulders, and Hand scale score: 6 versus 8; P=0.46) were comparable. Conclusions Following CAG, dTRA was associated with no differences in mean change of forearm RA IMT, hand pain, and function versus fTRA for CAG. Further investigation is warranted to elucidate mechanisms and predictors of RA healing and identify effective strategies to preserving RA integrity for repeated procedures. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04801901.