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A randomized comparison of modified subcutaneous "Z"-stitch versus manual compression to achieve hemostasis after large caliber femoral venous sheath removal

Pracon, Radoslaw; Bangalore, Sripal; Henzel, Jan; Cendrowska-Demkow, Iwona; Pregowska-Chwala, Barbara; Tarnowska, Agnieszka; Dzielinska, Zofia; Chmielak, Zbigniew; Witkowski, Adam; Demkow, Marcin
OBJECTIVES: To compare subcutaneous "Z"-stitch versus manual compression in attaining hemostasis after large bore femoral venous access, and to assess its impact on venous patency. BACKGROUND: Structural interventions increasingly require large caliber venous access, for which convenient, safe, and effective method of postprocedural hemostasis is needed. "Z"-stitch has been introduced for this purpose in some centers but systematic data on its performance is limited. METHODS: This single center study randomized consecutive patients with femoral venous access sites requiring >/=10F sheaths to the "Z"-stitch or manual compression for hemostasis in a 2:1 fashion. There were three co-primary endpoints: time to hemostasis, time to ambulation, and a composite safety endpoint comprising vascular access site complications. Groin Doppler-Duplex was performed with the stitch in place and after its removal. RESULTS: 86 consecutive patients with 90 access sites were randomized. Mean age was 61.7 +/- 19.1 years, 33.3% were men. Median sheath size was 14 F (range 10-22 F). Patients randomized to "Z"-stitch achieved hemostasis quicker [<1 min vs. 12.0 (IQR 10.0-15.0) min, P < 0.001] and ambulated sooner [7.0 (IQR 4.0-12.0) vs. 16.0 (IQR 11.8-20.3) hr post procedure, P < 0.001] when compared with manual compression alone. The "Z"-stitch reduced rates of access site complications (OR = 0.27, 95%CI 0.09-0.76, P = 0.01). All imaged veins were patent before and after stitch removal. CONCLUSIONS: The "Z"-stitch is a safe and effective method of achieving hemostasis after large bore femoral venous sheath removal and results in faster hemostasis, early patient ambulation and less access site complications, without compromising vein patency when compared with manual compression alone. (c) 2017 Wiley Periodicals, Inc.
PMID: 28303670
ISSN: 1522-726x
CID: 2490162

Does VALIDATE-SWEDEHEART invalidate the use of bivalirudin in myocardial infarction? [Comment]

Ong, Caroline; Bangalore, Sripal
PMCID:5863208
PMID: 29600024
ISSN: 2072-1439
CID: 3011022

Drug-Eluting vs Bare-Metal Stents in Patients With Chronic Kidney Disease and Coronary Artery Disease: Insights From a Systematic Review and Meta-Analysis

Volodarskiy, Alexander; Kumar, Sunil; Pracon, Radoslaw; Sidhu, Mandeep; Kretov, Evgeny; Mazurek, Tomasz; Bockeria, Olga; Kaul, Upendra; Bangalore, Sripal
BACKGROUND: Most drug-eluting stent (DES) trials have excluded patients with chronic kidney disease (CKD). The efficacy of DES implantation in patients with CKD is therefore not known. OBJECTIVES: To evaluate the outcomes with DES vs bare-metal stent (BMS) implantation in patients with CKD. METHODS AND RESULTS: MEDLINE, EMBASE, and CENTRAL were searched for studies including at least 100 patients with CKD (estimated glomerular filtration rate .05) except all-cause mortality, where there was no difference between DES vs BMS in RCTs (Pinteraction=.04). The effects were greater with 2nd-generation DES vs BMS (for example, ST: RR, 0.38; 95% CI, 0.20-0.72). CONCLUSIONS: In patients with CKD, the available evidence, largely from observational studies, suggests significantly fewer events with DES vs BMS with even a lower ST rate with 2nd-generation DES. These findings should be tested in large, randomized trials.
PMID: 28915510
ISSN: 1557-2501
CID: 2701932

Detection of Atherosclerotic Cardiovascular Disease in Patients with Advanced Chronic Kidney Disease in the Cardiology and Nephrology Communities

Chaudhry, Rafia I; Mathew, Roy O; Sidhu, Mandeep S; Sidhu-Adler, Preety; Lyubarova, Radmila; Rangaswami, Janani; Salman, Loay; Asif, Arif; Fleg, Jerome L; McCullough, Peter A; Maddux, Frank; Bangalore, Sripal
BACKGROUND:Atherosclerotic cardiovascular disease (ASCVD) is a leading cause of morbidity and mortality among patients with chronic kidney disease (CKD) with a glomerular filtration rate of < 60 mL/min/1.73 m2 body surface area. The availability of high-quality randomized controlled trial data to guide management for the population with CKD and ASCVD is limited. Understanding current practice patterns among providers caring for individuals with CKD and CVD is important in guiding future trial questions. METHODS:A qualitative survey study was performed. An electronic survey regarding the diagnosis and management of CVD in patients with CKD was conducted using a convenience sample of 450 practicing nephrology and cardiology providers. The survey was administered using Qualtrics® (https://www.qualtrics.com). RESULTS:There were a total of 113 responses, 81 of which were complete responses. More than 90% of the respondents acknowledged the importance of CVD as a cause of morbidity and mortality in patients with CKD. Outside the kidney transplant evaluation setting, 5% of the respondents would screen an asymptomatic patient with advanced CKD for ASCVD. Outside the kidney transplant evaluation scenario, the respondents did not opt for invasive management strategies in advanced CKD. CONCLUSIONS:The survey results reveal a lack of consensus among providers caring for patients with advanced CKD about the management of ASCVD in this setting. Future randomized controlled trials will be needed to better inform the clinical management of ASCVD in these patients. The limitations of the study include its small sample size and the relatively low response rate among the respondents.
PMID: 30078001
ISSN: 1664-5502
CID: 3226422

Cholesterol variability: a marker for increased risk or a risk factor?

Bangalore, Sripal
PMID: 29140424
ISSN: 1522-9645
CID: 2785272

Do We Need a Trial of DES Versus CABG Surgery in Diabetic Patients With ACS? [Editorial]

Bangalore, Sripal; Bhatt, Deepak L
PMID: 29241488
ISSN: 1558-3597
CID: 2837282

The State of the Absorb Bioresorbable Scaffold: Consensus From an Expert Panel

Bangalore, Sripal; Bezerra, Hiram G; Rizik, David G; Armstrong, Ehrin J; Samuels, Bruce; Naidu, Srihari S; Grines, Cindy L; Foster, Malcolm T; Choi, James W; Bertolet, Barry D; Shah, Atman P; Torguson, Rebecca; Avula, Surendra B; Wang, John C; Zidar, James P; Maksoud, Aziz; Kalyanasundaram, Arun; Yakubov, Steven J; Chehab, Bassem M; Spaedy, Anthony J; Potluri, Srini P; Caputo, Ronald P; Kondur, Ashok; Merritt, Robert F; Kaki, Amir; Quesada, Ramon; Parikh, Manish A; Toma, Catalin; Matar, Fadi; DeGregorio, Joseph; Nicholson, William; Batchelor, Wayne; Gollapudi, Raghava; Korngold, Ethan; Sumar, Riyaz; Chrysant, George S; Li, Jun; Gordon, John B; Dave, Rajesh M; Attizzani, Guilherme F; Stys, Tom P; Gigliotti, Osvaldo S; Murphy, Bruce E; Ellis, Stephen G; Waksman, Ron
Significant progress has been made in the percutaneous coronary intervention technique from the days of balloon angioplasty to modern-day metallic drug-eluting stents (DES). Although metallic stents solve a temporary problem of acute recoil following balloon angioplasty, they leave behind a permanent problem implicated in very late events (in addition to neoatherosclerosis). BRS were developed as a potential solution to this permanent problem, but the promise of these devices has been tempered by clinical trials showing increased risk of safety outcomes, both early and late. This is not too dissimilar to the challenges seen with first-generation DES in which refinement of deployment technique, prolongation of dual antiplatelet therapy, and technical iteration mitigated excess risk of very late stent thrombosis, making DES the treatment of choice for coronary artery disease. This white paper discusses the factors potentially implicated in the excess risks, including the scaffold consideration and deployment technique, and outlines patient and lesion selection, implantation technique, and dual antiplatelet therapy considerations to potentially mitigate this excess risk with the first-generation thick strut Absorb scaffold (Abbott Vascular, Abbott Park, Illinois). It remains to be seen whether these considerations together with technical iterations will ultimately close the gap between scaffolds and metal stents for short-term events while at the same time preserving options for future revascularization once the scaffold bioresorbs.
PMID: 29216997
ISSN: 1876-7605
CID: 2838002

Safety vs Efficacy of Lowering Blood Pressure

Bavishi, Chirag; Bangalore, Sripal; Messerli, Franz H
PMID: 28979975
ISSN: 2380-6591
CID: 2720202

Chelation Therapy as a Cardiovascular Therapeutic Strategy: the Rationale and the Data in Review

Mathew, Roy O; Schulman-Marcus, Joshua; Nichols, Elizabeth L; Newman, Jonathan D; Bangalore, Sripal; Farkouh, Michael; Sidhu, Mandeep S
Chelation therapy, typically used to remove heavy metal toxins, has also been controversially used as a treatment for coronary artery disease. The first Trial to Assess Chelation Therapy (TACT) aimed to provide evidence on chelation therapy's potential for benefit or harm. Although TACT had some significant results, the trial does not provide enough evidence to recommend routine chelation therapy and has limitations. The second TACT was recently funded reigniting a discussion about the value of chelation therapy, its efficacy, and allocation of research resources. Despite limited evidence, patients continue to pursue chelation therapy as a treatment for coronary artery disease. As the medical community has a responsibility to understand all treatments patients pursue, it is important to comprehensively appraise chelation therapy for cardiovascular disease. Understanding the background of heavy metal toxicity, the putative target of chelation therapy, on the cardiovascular system is important to contextualize the role of chelation therapy in cardiovascular disease prevention. We review the clinical evidence of heavy metal toxicity and cardiovascular disease, and available clinical trial data on use of chelation therapy to minimize the cardiovascular burden of heavy metal toxicity.
PMID: 29129003
ISSN: 1573-7241
CID: 2785412

Renal denervation: will the Phoenix rise from the ashes?

Messerli, Franz H; Bangalore, Sripal
PMID: 29020271
ISSN: 1522-9645
CID: 2732192