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634


Lifting the Regulatory Blanket Off of Covered Stents

Rao, Sunil V; Kandzari, David E
PMID: 37029040
ISSN: 1878-0938
CID: 5538162

Outcomes With Percutaneous Debulking of Tricuspid Valve Endocarditis

Zhang, Robert S; Alam, Usman; Maqsood, Muhammad H; Xia, Yuhe; Harari, Rafael; Keller, Norma; Elbaum, Lindsay; Rao, Sunil V; Alviar, Carlos L; Bangalore, Sripal
BACKGROUND:In patients with tricuspid valve infective endocarditis, percutaneous debulking is a treatment option. However, the outcomes of this approach are less well known. METHODS:We performed a retrospective analysis of all patients who underwent percutaneous vegetation debulking for tricuspid valve infective endocarditis from August 2020 to November 2022 at a large academic tertiary care public hospital. The primary efficacy outcome was procedural success defined by clearance of blood cultures. The primary safety outcome was any procedural complication. For the composite outcome of in-hospital mortality or heart block, outcomes were compared (sequential noninferiority and superiority) with published surgical outcomes data. RESULTS:=0.016). CONCLUSIONS:Percutaneous debulking is feasible, effective, and safe in treating patients with tricuspid valve infective endocarditis refractory to medical therapy.
PMID: 37417231
ISSN: 1941-7632
CID: 5535212

Outcomes and Institutional Variation in Arterial Access Among Patients With AMI and Cardiogenic Shock Undergoing PCI

Mahtta, Dhruv; Manandhar, Pratik; Wegermann, Zachary K; Wojdyla, Daniel; Megaly, Michael; Kochar, Ajar; Virani, Salim S; Rao, Sunil V; Elgendy, Islam Y
BACKGROUND:Contemporary data comparing the outcomes of transradial access (TRA) vs transfemoral access (TFA) among patients presenting with acute myocardial infarction and cardiogenic shock (AMI-CS) undergoing percutaneous coronary intervention (PCI) are limited. OBJECTIVES:This study examines in-hospital outcomes and institutional variation among patients with AMI-CS undergoing TRA-PCI vs TFA-PCI. METHODS:Patients admitted with AMI-CS from the NCDR CathPCI registry between April 2018 and June 2021 were included. Multivariable logistic regression and inverse probability weighting models were used to assess the association between access site and in-hospital outcomes. A falsification analysis using non-access site-related bleeding was performed. RESULTS:Among 35,944 patients with AMI-CS undergoing PCI, 25.6% were performed with TRA. The proportion of TRA-PCI increased over the study period (22.0% in the second quarter of 2018 vs 29.1% in the second quarter of 2021; P-trend <0.001). Significant institutional-level variability in the use of TRA-PCI was also observed: 20.9% of all sites using TRA in <2% of PCIs (low utilization) vs 1.9% of all sites using TRA in >80% of PCIs (high utilization). Patients undergoing TRA-PCI had a significantly lower adjusted incidence of major bleeding (odds ratio [OR]: 0.71; 95% confidence interval [CI]: 0.67-0.76), mortality (OR: 0.73; 95% CI: 0.69-0.78), vascular complications (OR: 0.67; 95% CI: 0.54-0.84), and new dialysis (OR: 0.86; 95% CI: 0.77-0.97). There was no difference in non-access site related bleeding (OR: 0.93; 95% CI: 0.84-1.03). Sensitivity analyses revealed similar benefit with TRA-PCI among patients without arterial cross-over. There were no significant interactions observed between TRA-PCI with mechanical circulatory support and in-hospital outcomes. CONCLUSIONS:In this large nationwide contemporary analysis of patients with AMI-CS, about quarter of PCIs were performed via TRA with wide variability across US institutions. TRA-PCI was associated with significantly lower incidence of in-hospital major bleeding, mortality, vascular complications, and new dialysis. This benefit was observed irrespective of mechanical circulatory support use.
PMID: 37380235
ISSN: 1876-7605
CID: 5538672

Defining Strategies of Modulation of Antiplatelet Therapy in Patients With Coronary Artery Disease: A Consensus Document from the Academic Research Consortium

Capodanno, Davide; Mehran, Roxana; Krucoff, Mitchell W; Baber, Usman; Bhatt, Deepak L; Capranzano, Piera; Collet, Jean-Philippe; Cuisset, Thomas; De Luca, Giuseppe; De Luca, Leonardo; Farb, Andrew; Franchi, Francesco; Gibson, C Michael; Hahn, Joo-Yong; Hong, Myeong-Ki; James, Stefan; Kastrati, Adnan; Kimura, Takeshi; Lemos, Pedro A; Lopes, Renato D; Magee, Adrian; Matsumura, Ryosuke; Mochizuki, Shuichi; O'Donoghue, Michelle L; Pereira, Naveen L; Rao, Sunil V; Rollini, Fabiana; Shirai, Yuko; Sibbing, Dirk; Smits, Peter C; Steg, P Gabriel; Storey, Robert F; Ten Berg, Jurrien; Valgimigli, Marco; Vranckx, Pascal; Watanabe, Hirotoshi; Windecker, Stephan; Serruys, Patrick W; Yeh, Robert W; Morice, Marie-Claude; Angiolillo, Dominick J
Antiplatelet therapy is the mainstay of pharmacologic treatment to prevent thrombotic or ischemic events in patients with coronary artery disease treated with percutaneous coronary intervention and those treated medically for an acute coronary syndrome. The use of antiplatelet therapy comes at the expense of an increased risk of bleeding complications. Defining the optimal intensity of platelet inhibition according to the clinical presentation of atherosclerotic cardiovascular disease and individual patient factors is a clinical challenge. Modulation of antiplatelet therapy is a medical action that is frequently performed to balance the risk of thrombotic or ischemic events and the risk of bleeding. This aim may be achieved by reducing (ie, de-escalation) or increasing (ie, escalation) the intensity of platelet inhibition by changing the type, dose, or number of antiplatelet drugs. Because de-escalation or escalation can be achieved in different ways, with a number of emerging approaches, confusion arises with terminologies that are often used interchangeably. To address this issue, this Academic Research Consortium collaboration provides an overview and definitions of different strategies of antiplatelet therapy modulation for patients with coronary artery disease, including but not limited to those undergoing percutaneous coronary intervention, and consensus statements on standardized definitions.
PMID: 37335828
ISSN: 1524-4539
CID: 5541042

International Psychological Well-Being Survey of Interventional Cardiologists

Simsek, Bahadir; Rempakos, Athanasios; Kostantinis, Spyridon; Karacsonyi, Judit; Rangan, Bavana V; Mastrodemos, Olga C; Kirtane, Ajay J; Bortnick, Anna E; Jneid, Hani; Azzalini, Lorenzo; Milkas, Anastasios; Alaswad, Khaldoon; Linzer, Mark; Egred, Mohaned; Allana, Salman S; Rao, Sunil V; Sandoval, Yader; Brilakis, Emmanouil S
PMID: 37316149
ISSN: 1876-7605
CID: 5540982

Leveraging electronic health records to streamline the conduct of cardiovascular clinical trials

Khan, Muhammad Shahzeb; Usman, Muhammad Shariq; Talha, Khawaja M; Van Spall, Harriette G C; Greene, Stephen J; Vaduganathan, Muthiah; Khan, Sadiya S; Mills, Nicholas L; Ali, Ziad A; Mentz, Robert J; Fonarow, Gregg C; Rao, Sunil V; Spertus, John A; Roe, Matthew T; Anker, Stefan D; James, Stefan K; Butler, Javed; McGuire, Darren K
Conventional randomized controlled trials (RCTs) can be expensive, time intensive, and complex to conduct. Trial recruitment, participation, and data collection can burden participants and research personnel. In the past two decades, there have been rapid technological advances and an exponential growth in digitized healthcare data. Embedding RCTs, including cardiovascular outcome trials, into electronic health record systems or registries may streamline screening, consent, randomization, follow-up visits, and outcome adjudication. Moreover, wearable sensors (i.e. health and fitness trackers) provide an opportunity to collect data on cardiovascular health and risk factors in unprecedented detail and scale, while growing internet connectivity supports the collection of patient-reported outcomes. There is a pressing need to develop robust mechanisms that facilitate data capture from diverse databases and guidance to standardize data definitions. Importantly, the data collection infrastructure should be reusable to support multiple cardiovascular RCTs over time. Systems, processes, and policies will need to have sufficient flexibility to allow interoperability between different sources of data acquisition. Clinical research guidelines, ethics oversight, and regulatory requirements also need to evolve. This review highlights recent progress towards the use of routinely generated data to conduct RCTs and discusses potential solutions for ongoing barriers. There is a particular focus on methods to utilize routinely generated data for trials while complying with regional data protection laws. The discussion is supported with examples of cardiovascular outcome trials that have successfully leveraged the electronic health record, web-enabled devices or administrative databases to conduct randomized trials.
PMID: 37098746
ISSN: 1522-9645
CID: 5465122

In-hospital Outcomes of Patients With and Without Previous Coronary Artery Bypass Graft Surgery Who Present With a Non-ST-Segment Elevation Myocardial Infarction

Dhaduk, Nehal; Xia, Yuhe; Feit, Frederick; Mamas, Mamas; Alviar, Carlos; Keller, Norma; Rao, Sunil V; Bangalore, Sripal
The clinical course of patients with a previous coronary artery bypass graft surgery (CABG) presenting with non-ST-elevation myocardial infarction (NSTEMI) is not well defined. We aimed to compare the management and outcomes of patients with and without previous CABG who present with an NSTEMI. Patients hospitalized with an NSTEMI between 2002 and 2018 were identified from the National Inpatient Sample. The baseline characteristics and outcomes of patients with and without a previous CABG were compared. The outcomes included the rates of invasive procedures (defined as coronary angiography, percutaneous coronary intervention [PCI], or CABG), and its individual components, and in-hospital mortality. A total of 1,445,545 cases of NSTEMI were found, of which 133,691 (9.3%) had a previous CABG. Patients with a previous CABG were older (72.4 vs 68.6 years, p <0.001), more likely men (68.8% vs 56.9%, p <0.001), and of White race (79.7% vs 74.8%, p <0.001). The previous CABG cohort had lower rates of invasive procedures (50.4% vs 65.6%, p <0.001), PCI (23.7% vs 32.0%, p <0.001), or CABG (1.2% vs 10.6%; p <0.001) in the unmatched analysis. The results were consistent in the propensity score-matched analysis with the previous CABG group less likely to receive any invasive procedures (odds ratio [OR] 0.48, 95% confidence interval [CI] 0.47 to 0.49), including coronary angiography (OR 0.54, 95% CI 0.53 to 0.55), PCI (OR 0.66, 95% CI 0.64 to 0.67), or repeat CABG (OR 0.11, 95% CI 0.10 to 0.12). Moreover, the risk of in-hospital mortality was higher in the previous CABG group (OR 1.15, 95% CI 1.10 to 1.21). In the subset of patients who were revascularized in both groups, this excess mortality was no longer observed (OR 0.82, 95% CI 0.66 to 1.03). In conclusion, a previous CABG in patients who present with NSTEMI is associated with lower rates of invasive procedures and revascularization and higher in-hospital mortality than patients without a previous CABG.
PMID: 36989550
ISSN: 1879-1913
CID: 5463292

Integrating Structural Heart Disease Trainees within the Dynamics of the Heart Team: The Case for Multimodality Training

Ibrahim, Homam; Lowenstern, Angela; Goldsweig, Andrew M.; Rao, Sunil V.
Structural heart disease is a rapidly evolving field. However, training in structural heart disease is still widely variable and has not been standardized. Furthermore, integration of trainees within the heart team has not been fully defined. In this review, we discuss the components and function of the heart team, the challenges of current structural heart disease models, and possible solutions and suggestions for integrating trainees within the heart team.
SCOPUS:85158876972
ISSN: 2474-8706
CID: 5500562

Same day discharge versus overnight observation following chronic total occlusion percutaneous coronary intervention: Insights from the PROGRESS-CTO registry

Simsek, Bahadir; Khatri, Jaikirshan; Young, Laura; Kostantinis, Spyridon; Karacsonyi, Judit; Rempakos, Athanasios; Alaswad, Khaldoon; Jaffer, Farouc A; Doshi, Darshan; Gorgulu, Sevket; Goktekin, Omer; Kerrigan, Jimmy; Haddad, Elias V; Rinfret, Stephane; Jaber, Wissam A; Nicholson, William; Krestyaninov, Oleg; Khelimskii, Dimitrii; Choi, James W; Patel, Taral N; Jefferson, Brian K; Bradley, Steven M; Rao, Sunil V; Rangan, Bavana V; Allana, Salman S; Sandoval, Yader; Burke, M Nicholas; Brilakis, Emmanouil S; Poommipanit, Paul B
BACKGROUND:Same day discharge (SDD) following chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. METHODS:We evaluated the clinical, angiographic, and procedural characteristics of patients discharged the same day versus those kept for overnight observation in the Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS-CTO, NCT02061436). RESULTS:Of the 7181 patients who underwent CTO PCI, 943 (13%) had SDD. The SDD rate increased from 3% in 2015 to 21% in 2022. Patients with SDD were less likely to have a history of heart failure (21% vs. 26%, p = 0.005), chronic lung disease (10% vs. 15%, p = 0.001), or anemia (12% vs. 19%, p < 0.001). Technical success (87% vs. 88%, p = 0.289) was similar, but in-hospital major adverse cardiovascular events (0.0% vs. 0.4%, p = 0.041) were lower in SDD. In multivariable logistic regression analysis, prior myocardial infarction odds ratio (OR): 0.71 (95% confidence interval [CI]: 0.59-0.87, p = 0.001), chronic lung disease OR: 0.64 (95% CI: 0.47-0.88, p = 0.006), and increasing procedure time OR: 0.93 (95% CI: 0.91-0.95, p < 0.001, per 10-min increase) were associated with overnight observation, while radial-only access OR: 2.45 (95% CI: 2.03-2.96, p < 0.001) had the strongest association with SDD. In the SDD, 2 (0.4%) of 514 patients were readmitted, due to retroperitoneal bleeding (n = 1) and ischemic stroke (n = 1). CONCLUSION/CONCLUSIONS:The overall frequency of SDD after CTO PCI was 13% and has been increasing over time. SDD is feasible in select patients following CTO PCI, and radial-only access had the strongest association with SDD.
PMID: 36960766
ISSN: 1522-726x
CID: 5462902

Optimal Hemostatic Band Duration After Transradial Angiography or Intervention: Insights From a Mixed Treatment Comparison Meta-Analysis of Randomized Trials

Maqsood, Muhammad Haisum; Pancholy, Samir; Tuozzo, Kristin A; Moskowitz, Nicole; Rao, Sunil V; Bangalore, Sripal
BACKGROUND:The optimal duration of hemostatic compression post transradial access is controversial. Longer duration increases the risk of radial artery occlusion (RAO) while shorter duration increases the risk of access site bleeding or hematoma. As such, a target of 2 hours is typically used. Whether a shorter or longer duration is better is not known. METHODS:A PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized clinical trials of different duration (<90 minutes, 90 minutes, 2 hours, and 2-4 hours) of hemostasis banding. The efficacy outcome was RAO, primary safety outcome was access site hematoma, and secondary safety outcome was access site rebleeding. Primary analysis compared the effect of various duration in reference to the 2 hours duration using a mixed treatment comparison meta-analysis. RESULTS:Of the 10 randomized clinical trials included with 4911 patients, when compared to the 2-hour reference duration, there was a significantly higher risk of access site hematoma with 90 minutes (odds ratio, 2.39 [95% CI, 1.40-4.06]) and <90 minutes (odds ratio, 3.61 [95% CI, 1.79-7.29]) but not with the 2 to 4 hours duration. When compared with the 2-hour reference, there was no significant difference in access site rebleeding or RAO with shorter or longer duration but the point estimates favored longer duration for access site rebleeding and shorter duration for RAO. Duration of <90 minutes and 90 minutes ranked 1 and duration of 2 hours ranked 2 as the most efficacious duration whereas duration of 2 hours ranked 1 and 2 to 4 hours ranked 2 as the safest duration. CONCLUSIONS:In patients undergoing transradial access for coronary angiography or intervention, a hemostasis duration of 2 hours offers the best balance for efficacy (prevention of RAO) and safety (prevention of access site hematoma/rebleeding).
PMID: 36802805
ISSN: 1941-7632
CID: 5427382