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Renal denervation - radiofrequency vs. ultrasound: insights from a mixed treatment comparison meta-analysis of randomized sham controlled trials

Bangalore, Sripal; Maqsood, M Haisum; Bakris, George L; Rao, Sunil V; Messerli, Franz H
BACKGROUND AND AIMS/OBJECTIVE:Multiple randomized trials have shown that renal denervation (RDN) reduces blood pressure (BP) when compared with sham control but the antihypertensive efficacy of radiofrequency vs. ultrasound-based RDN is uncertain. We aimed to compare the outcomes of radiofrequency RDN (rRDN) and ultrasound RDN (uRDN), when compared with sham in patients with hypertension. METHODS:PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized sham-controlled trials (RCTs) of rRDN or uRDN or for trials of rRDN vs. uRDN. Primary efficacy outcome was 24-h ambulatory SBP. A mixed treatment comparison meta-analysis was performed comparing the efficacy and safety against sham and against each other. RESULTS:Among 13 RCTs that enrolled 2285 hypertensive patients, rRDN reduced 24-h ambulatory SBP [(MD = 2.34 mmHg; 95% confidence interval (95% CI): 0.72-3.95], office SBP (MD = 5.04 mmHg; 95% CI: 2.68-7.40)], and office DBP (MD = 2.95 mmHg; 95% CI: 1.68-4.22) when compared with sham. Similarly, uRDN reduced 24-h ambulatory SBP (MD = 4.74 mmHg; 95% CI: 2.80-6.67), day-time ambulatory SBP (MD = 5.40 mmHg; 95% CI: 3.68-7.13), night-time ambulatory SBP (MD = 3.84 mmHg; 95% CI: 0.02-7.67), and office SBP (3.98 mmHg; 95% CI: 0.78-7.19) when compared with sham. There was significantly greater reduction in 24-h ambulatory SBP (MD = 2.40 mmHg; 95% CI: 0.09-4.71), day-time ambulatory SBP (MD = 4.09 mmHg; 95% CI: 1.61-6.56), and night-time ambulatory SBP (MD = 5.76 mmHg; 95% CI: 0.48-11.0) with uRDN when compared with rRDN. For primary efficacy outcome, uRDN ranked #1, followed by rRDN (#2), and sham (#3). CONCLUSION/CONCLUSIONS:In hypertensive patients, rRDN and uRDN significantly reduced 24-h ambulatory and office SBP when compared with sham control with significantly greater reduction in ambulatory BP with uRDN than with rRDN at 4 months (mean) of follow-up. A large-scale randomized head-to-head trial of rRDN or uRDN is warranted to evaluate if there are differences in efficacy.
PMID: 39466083
ISSN: 1473-5598
CID: 5746742

The DanGer of Using Age to Decide About Using Microaxial Flow Pumps in Cardiogenic Shock [Editorial]

Samsky, Marc D; Kadosh, Bernard S; Nanna, Michael G; Rao, Sunil V
PMID: 39818661
ISSN: 1558-3597
CID: 5777132

Outcomes with distal transradial access in patients with advanced chronic kidney disease

Mosarla, Ramya C; Ahmed, Hamza; Rao, Shaline D; Kadosh, Bernard S; Cruz, Jennifer A; Goldberg, Randal I; Saraon, Tajinderpal; Gelb, Bruce E; Mattoo, Aprajita; Rao, Sunil V; Bangalore, Sripal
Radial artery occlusion (RAO), a complication of transradial access, has an incidence of 4.0% to 9.1% in patients with advanced chronic kidney disease (CKD) and may preclude its use creation of arteriovenous fistula. Distal transradial access (dTRA) has lower rates of RAO compared with TRA, but prior studies excluded patients with advanced CKD. This was a single center study of patients with advanced CKD who underwent coronary procedures with dTRA from January 1, 2019 to May 12, 2022 who were retrospectively evaluated for radial artery patency in follow-up with reverse Barbeau testing or repeat access of the artery. Of 71 patients, 66% were on hemodialysis and the remainder had CKD 3 to 5. Access was ultrasound-guided, and all received adequate spasmolytic therapy and patent hemostasis. Proximal radial arteries were patent in 100% of the patients at follow-up. Our data suggest that dTRA is safe for patients with advanced CKD and preserves radial artery patency.
PMID: 39150435
ISSN: 1557-2501
CID: 5727012

Evaluation of Peer Review of Percutaneous Coronary Intervention Operator Performance

Doll, Jacob A; Hebbe, Annika L; Simons, Carol E; Stein, Elliot J; Eisenbarth, Stephan; Waldo, Stephen W; Rao, Sunil V; Au, David H
BACKGROUND/UNASSIGNED:Case-based peer review of percutaneous coronary intervention (PCI) is used by many hospitals for quality improvement and to make decisions regarding physician competency. However, there are no studies testing the reliability or validity of peer review for PCI performance evaluation. METHODS/UNASSIGNED:We recruited interventional cardiologists from 12 Veterans Affairs Health System facilities throughout the United States to provide PCI cases for review. Ten reviewers performed blinded reviews such that each case was reviewed twice. Cases were rated on a scale of 1 to 5 (with 5 being the best) for 6 care domains (Appropriateness, Lesion Suitability, Strategy, Technical Performance, Outcome, and Documentation) with a summary performance score calculated as the average of all domains. Separately, reviewers determined whether the standard of care was met. Interobserver reliability of the summary performance score was calculated using interclass correlation coefficient. We examined procedural complications and 30-day mortality and major adverse cardiac events for all PCIs performed by these operators from 2019 to 2022 when stratified in tertiles by summary performance score. RESULTS/UNASSIGNED:<0.01) compared with the highest-rated tertile. CONCLUSIONS/UNASSIGNED:Case-based peer review identifies variation in physician performance that is correlated with PCI outcomes. However, reviewer disagreements about the standard of care raise concerns about the use of peer review for high-stakes assessments of physician competency.
PMID: 39749476
ISSN: 1941-7705
CID: 5778282

Restrictive versus Liberal Transfusion in Myocardial Infarction - A Patient-Level Meta-Analysis

Carson, Jeffrey L; Fergusson, Dean A; Noveck, Helaine; Mallick, Ranjeeta; Simon, Tabassome; Rao, Sunil V; Cooper, Howard; Stanworth, Simon J; Portela, Gerard T; Ducrocq, Gregory; Bertolet, Marnie; DeFilippis, Andrew P; Goldsweig, Andrew M; Kim, Sarang; Triulzi, Darrell J; Menegus, Mark A; Abbott, J Dawn; Lopes, Renato D; Brooks, Maria Mori; Alexander, John H; Hébert, Paul C; Goodman, Shaun G; Steg, P Gabriel
BACKGROUND:Clinical guidelines have concluded that there are insufficient data to provide recommendations for the hemoglobin threshold for the use of red cell transfusion in patients with acute myocardial infarction (MI) and anemia. After the recent publication of the Myocardial Infarction and Transfusion (MINT) trial, we performed an individual patient-level data meta-analysis to evaluate the effect of restrictive versus liberal blood transfusion strategies. METHODS:We conducted searches in major databases. Eligible trials randomly assigned patients with MI and anemia to either a restrictive (i.e., transfusion threshold of 7-8 g/dl) or liberal (i.e., transfusion threshold of 10 g/dl) red cell transfusion strategy. We used individual patient data from each trial. The primary outcome was a composite of 30-day mortality or MI. RESULTS:We included 4311 patients from four trials. The primary outcome occurred in 334 patients (15.4%) in the restrictive strategy and 296 patients (13.8%) in the liberal strategy (relative risk [RR] 1.13, 95% confidence interval [CI], 0.97 to 1.30). Death at 30 days occurred in 9.3% of patients in the restrictive strategy and in 8.1% of patients in the liberal strategy (RR 1.15, 95% CI, 0.95 to 1.39). Cardiac death at 30 days occurred in 5.5% of patients in the restrictive strategy and in 3.7% of patients in the liberal strategy (RR 1.47, 95% CI, 1.11 to 1.94). Heart failure (RR 0.89, 95% CI, 0.70 to 1.13) was similar in the transfusion strategies. All-cause mortality at 6 months occurred in 20.5% of patients in the restrictive strategy compared with 19.1% of patients in the liberal strategy (hazard ratio 1.08, 95% CI, 1.05 to 1.11). CONCLUSIONS:Pooling individual patient data from four trials did not find a definitive difference in our primary composite outcome of MI or death at 30 days. At 6 months, a restrictive transfusion strategy was associated with increased all-cause mortality. (Partially funded by a grant from the U.S. National Heart, Lung, and Blood Institute [R01HL171977].).
PMID: 39714935
ISSN: 2766-5526
CID: 5767312

Inflammation in the Peri-ACS Period: Ready for Prime Time?

Rao, Sunil V; Lerner, Johanna Ben-Ami
Inflammation has been demonstrated to negatively impact patients in the peri-ACS period. This narrative review outlines the inflammatory response in ACS, highlighting the role of the NLRP3 inflammasome pathway following acute plaque rupture and coronary intervention and its potential as a pharmacologic target. RECENT: nvestigators have leveraged medications targeting the NLRP3 inflammasome currently used for other inflammatory pathologies, including colchicine, tocilizumab and anakinra. Investigation into these drugs in the peri-ACS period has yielded varying results, with the most encouraging findings in ACS patients treated with tocilizumab. More conflicting data exists for the role of colchicine and anakinra, with many studies limited in their power to detect clinical outcomes and heterogeneity in their patient populations and endpoints. Despite conflicting data, the NLRP3 remains an attractive therapeutic target in the peri-ACS period. Further investigation is required to prove benefit and safety with large clinical trials adequately powered for clinical outcomes.
PMID: 39714732
ISSN: 1534-6242
CID: 5767282

The Utility of Coronary Revascularization to Reduce Ventricular Arrhythmias in Coronary Artery Disease Patients: A Systematic Review

Junarta, Joey; Siddiqui, Muhammad U; Abaza, Ehab; Zhang, Peter; Patel, Anjani; Park, David S; Aizer, Anthony; Razzouk, Louai; Rao, Sunil V
Ventricular arrhythmias (VA) are a major cause of morbidity and mortality in patients with coronary artery disease (CAD). Current guidelines recommend revascularization of significant CAD to improve survival in patients with ventricular fibrillation (VF), polymorphic ventricular tachycardia (VT), or those who are post-cardiac arrest. However, revascularization is not recommended for CAD patients with suspected scar-mediated monomorphic VT. There is a paucity of data detailing the utility of revascularization in reducing VA in CAD patients who do not present with acute coronary syndrome (ACS) and are not immediately post-cardiac arrest, which is the focus of this review. Medline, Scopus, and the Cochrane Central Register of Controlled Trials were systematically searched to identify relevant studies addressing this question. Studies that included patients presenting with ACS or those who were immediately post-cardiac arrest at the time of revascularization were excluded. In total, five studies comprising 2663 patients were reviewed.
PMID: 39696811
ISSN: 1522-726x
CID: 5764642

Correction: Factor XIa inhibition as a therapeutic strategy for atherothrombosis

Bailey, Eric; Lopes, Renato D; Gibson, C Michael; Eikelboom, John W; Rao, Sunil V
PMID: 39681813
ISSN: 1573-742x
CID: 5764222

Restrictive Versus Liberal Transfusion in Patients with Type 1 or Type 2 Myocardial Infarction: A Prespecified Analysis of the Myocardial Ischemia and Transfusion (MINT) Trial

DeFilippis, Andrew P; Abbott, J Dawn; Herbert, Brandon M; Bertolet, Marnie H; Chaitman, Bernard R; White, Harvey D; Goldsweig, Andrew M; Polonsky, Tamar S; Gupta, Rajesh; Alsweiler, Caroline; Silvain, Johanne; de Barros E Silva, Pedro G M; Hillis, Graham S; Daneault, Benoit; Tessalee, Meechai; Menegus, Mark A; Rao, Sunil V; Lopes, Renato D; Hébert, Paul C; Alexander, John H; Brooks, Maria M; Carson, Jeffrey L; Goodman, Shaun G; ,
BACKGROUND:The MINT trial raised concern for harm from a restrictive versus liberal transfusion strategy in patients with acute myocardial infarction (MI) and anemia. Type 1 and type 2 MI are distinct pathophysiological entities that may respond differently to blood transfusion. This analysis sought to determine if the effects of transfusion varied among patients with a type 1 or a type 2 MI and anemia. We hypothesized that the liberal transfusion strategy would be of greater benefit in type 2 than in type 1 MI. METHODS:We compared rates of death or MI at 30 days in patients with type 1 (n=1460) and type 2 (n=1955) MI and anemia who were randomly allocated to a restrictive (threshold of 7 to 8 g/dL) or a liberal (threshold of 10 g/dL) transfusion strategy. RESULTS:= 0.16). CONCLUSIONS:The concern for harm with a restrictive transfusion strategy in patients with acute MI and anemia raised in the MINT primary outcome manuscript may be more apparent in patients with type 1 than type 2 MI. CLINICAL TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov number, NCT02981407.
PMID: 39206549
ISSN: 1524-4539
CID: 5729912

Rationale and design of the PE-TRACT trial: A multicenter randomized trial to evaluate catheter-directed therapy for the treatment of intermediate-risk pulmonary embolism

Sista, Akhilesh K; Troxel, Andrea B; Tarpey, Thaddeus; Parpia, Sameer; Goldhaber, Samuel Z; Stringer, William W; Magnuson, Elizabeth A; Cohen, David J; Kahn, Susan R; Rao, Sunil V; Morris, Timothy A; Goldfeld, Keith S; Vedantham, Suresh
BACKGROUND:The optimal management of patients with intermediate-risk pulmonary embolism (PE), who have right heart dysfunction (determined by a combination of imaging and cardiac biomarkers) but a normal blood pressure, is uncertain. These patients suffer from reduced functional capacity and a lower quality of life over the long-term, despite use of anticoagulant therapy. Catheter-directed therapy (CDT) is a promising treatment for acute PE that rapidly removes thrombus and potentially improves cardiac dysfunction. However, CDT has risk and is costly, and it is not known whether it improves long-term cardiorespiratory fitness and/or quality of life compared with anticoagulation alone. METHODS:) with cardiopulmonary exercise testing at 3 months and reduce New York Heart Association (NYHA) Class at 12 months compared with No-CDT. These 2 primary efficacy outcomes will be analyzed sequentially using a "gatekeeping" procedure; for NYHA class to be compared, peak oxygen consumption must first be shown to be significantly increased by CDT. Safety and cost-effectiveness will also be assessed. CONCLUSION/CONCLUSIONS:When completed, PE-TRACT will provide important evidence regarding the benefits and risks of CDT to treat intermediate-risk PE compared with anticoagulation alone. TRIAL REGISTRATION/BACKGROUND:clinicaltrials.gov: NCT05591118.
PMID: 39638275
ISSN: 1097-6744
CID: 5780192