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Preventing Acute Radial Artery Occlusion: A Battle on Multiple Fronts [Comment]

Rymer, Jennifer A; Rao, Sunil V
PMID: 30391385
ISSN: 1876-7605
CID: 5222032

Heparin use for diagnostic cardiac catheterization with a radial artery approach: An international survey of practice patterns

Bossard, Matthias; Lavi, Shahar; Rao, Sunil V; Cohen, David J; Cantor, Warren J; Bainey, Kevin R; Valettas, Nicholas; Jolly, Sanjit S; Mehta, Shamir R
OBJECTIVES:We aimed to describe global practice patterns of unfractionated heparin (UFH) use for diagnostic transradial cardiac catheterization. BACKGROUND:The use of the radial artery approach for cardiac catheterization is increasing globally. Limited contemporary data exist to support the use or optimal dosing of UFH to prevent radial artery occlusion (RAO) and other thromboembolic complications. METHODS:We performed a web-based international survey of 450 interventional cardiologists from 34 countries. We collected information regarding the experience and use of UFH for diagnostic transradial cardiac catheterization. RESULTS:The survey was conducted between June and July 2016 and was completed by 227 (50.4%) interventional cardiologists. Overall, 83.3% performed >75% of their coronary angiograms via a radial approach, with the plurality (41.9%) having 10-20 years of clinical experience. Of all respondents, 7.5% did not use UFH for routine diagnostic transradial heart catheterization. Of the 92.5% who did use UFH, it was preferentially administered intra-arterially by 60% and intravenously by 40%. The majority (62.6%) of interventionalists used a fixed UFH dose with 5,000 IU being the most common dose (used in 48%). For those using a weight-based UFH (50 IU/kg) dosing regimen for diagnostic procedures (36.1%), the administered UFH dose ranged from 2,000 up to 10,000 IU. CONCLUSIONS:Despite the lack of firm evidence, the majority of interventional cardiologists who participated in the survey use UFH to prevent RAO for diagnostic transradial coronary angiography. However, there exist large practice disparities with regards to dose and route of administration. Given this knowledge gap, a dedicated randomized trial is warranted.
PMID: 29405556
ISSN: 1522-726x
CID: 5221792

Efficacy and Safety of Drug-Eluting Stents Optimized for Biocompatibility vs Bare-Metal Stents With a Single Month of Dual Antiplatelet Therapy: A Meta-analysis

Shah, Rahman; Rao, Sunil V; Latham, Samuel B; Kandzari, David E
Importance:A significant number of patients receive bare-metal stents (BMSs) instead of drug-eluting stents (DESs) to shorten the duration of dual antiplatelet therapy (DAPT). Emerging evidence suggests that new-generation DESs, particularly those optimized for biocompatibility, may be more efficacious and safer than BMSs, even with a single month of DAPT after stent implantation. Objective:To evaluate the efficacy and safety of DESs compared with BMSs for coronary intervention with a single month of DAPT. Data Sources:Human studies found in PubMed, the Cochrane databases through April 2018, and reference lists of selected articles. Study Selection:Randomized clinical trials were included if they enrolled patients undergoing percutaneous coronary intervention and randomly assigned each patient to treatment with either DESs or BMSs. The additional inclusion criterion was use of only 1 month of DAPT poststent implantation. Data Extraction and Synthesis:Two reviewers independently extracted the data. Odds ratios (ORs) were calculated using random-effects models. Main Outcomes and Measures:The efficacy end points were major adverse cardiac events, myocardial infarction, target vessel revascularization, ischemia-driven target lesion revascularization, cardiac mortality, and all-cause mortality at 1 year. The safety outcomes were stent thrombosis and bleeding complications. Results:Data from 3 randomized clinical trials involving 3943 patients were included (2457 men [62.3%]; mean [SD] age ranging from 75.7 [9.3] years to 81.4 [4.3] years per trial subgroup). Coronary intervention with DESs reduced the rates for major adverse cardiac events (OR, 0.68 [95% CI, 0.57-0.82]; P < .001), target lesion revascularization (OR, 0.38 [95% CI, 0.22-0.67]; P = .001), target vessel revascularization (OR, 0.50 [95% CI, 0.38-0.65]; P < .001), and myocardial infarction (OR, 0.51 [95% CI, 0.31-0.83]; P = .01) compared with BMSs at 1 year. The incidence of stent thrombosis was also lower with DESs compared with BMSs (1.8% vs 2.8%), but this difference was not statistically significant in the random-effects model. Additionally, the 2 stent types did not differ in the risks of all-cause mortality, cardiac mortality, and bleeding. Conclusions and Relevance:In the limited number of randomized clinical trials comparing DESs with BMSs with shortened DAPT durations in patients who have high bleeding risk or are uncertain candidates for prolonged DAPT, coronary intervention with specific DESs optimized for biocompatibility is not only safe but also efficacious, even with only 1 month of DAPT.
PMID: 30383145
ISSN: 2380-6591
CID: 5222022

Association of Same-Day Discharge After Elective Percutaneous Coronary Intervention in the United States With Costs and Outcomes

Amin, Amit P; Pinto, Duane; House, John A; Rao, Sunil V; Spertus, John A; Cohen, Mauricio G; Pancholy, Samir; Salisbury, Adam C; Mamas, Mamas A; Frogge, Nathan; Singh, Jasvindar; Lasala, John; Masoudi, Frederick A; Bradley, Steven M; Wasfy, Jason H; Maddox, Thomas M; Kulkarni, Hemant
Importance:Same-day discharge (SDD) after elective percutaneous coronary intervention (PCI) is associated with lower costs and preferred by patients. However, to our knowledge, contemporary patterns of SDD after elective PCI with respect to the incidence, hospital variation, trends, costs, and safety outcomes in the United States are unknown. Objective:To examine (1) the incidence and trends in SDD; (2) hospital variation in SDD; (3) the association between SDD and readmissions for bleeding, acute kidney injury (AKI), acute myocardial infarction (AMI), or mortality at 30, 90, and 365 days after PCI; and (4) hospital costs of SDD and its drivers. Design, Setting, and Participants:This observational cross-sectional cohort study included 672 470 patients enrolled in the nationally representative Premier Healthcare Database who underwent elective PCI from 493 hospitals between January 2006 and December 2015 with 1-year follow-up. Exposures:Same-day discharge, defined by identical dates of admission, PCI procedure, and discharge. Main Outcomes and Measures:Death, bleeding requiring a blood transfusion, AKI and AMI at 30, 90, or 365 days after PCI, and costs from hospitals' perspective, inflated to 2016. Results:Among 672 470 elective PCIs, 221 997 patients (33.0%) were women, 30 711 (4.6%) were Hispanic, 51 961 (7.7%) were African American, and 491 823 (73.1%) were white. The adjusted rate of SDD was 3.5% (95% CI, 3.0%-4.0%), which increased from 0.4% in 2006 to 6.3% in 2015. We observed substantial hospital variation for SDD from 0% to 83% (median incidence rate ratio, 3.82; 95% CI, 3.48-4.23), implying an average (median) 382% likelihood of SDD at one vs another hospital. Among SDD (vs non-SDD) patients, there was no higher risk of death, bleeding, AKI, or AMI at 30, 90, or 365 days. Same-day discharge was associated with a large cost savings of $5128 per procedure (95% CI, $5006-$5248), driven by reduced supply and room and boarding costs. A shift from existing SDD practices to match top-decile SDD hospitals could annually save $129 million in this sample and $577 million if adopted throughout the United States. However, residual confounding may be present, limiting the precision of the cost estimates. Conclusions and Relevance:Over 2006 to 2015, SDD after elective PCI was infrequent, with substantial hospital variation. Given the safety and large savings of more than $5000 per PCI associated with SDD, greater and more consistent use of SDD could markedly increase the overall value of PCI care.
PMID: 30267035
ISSN: 2380-6591
CID: 5222002

Impact of sheath size and hemostasis time on radial artery patency after transradial coronary angiography and intervention in Japanese and non-Japanese patients: A substudy from RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT) randomized multicenter trial

Aminian, Adel; Saito, Shigeru; Takahashi, Akihiko; Bernat, Ivo; Jobe, Robert Lee; Kajiya, Takashi; Gilchrist, Ian C; Louvard, Yves; Kiemeneij, Ferdinand; van Royen, Niels; van Leeuwen, Maarten; Yamazaki, Seiji; Matsukage, Takashi; Iglesias, Juan F; Rao, Sunil V
BACKGROUND:During transradial (TR) access, it remains unclear whether differences in baseline patients characteristics and hemostasis care impact the rate of radial artery occlusion (RAO). We sought to compare the rate of RAO after TR access with the 6 French(Fr) Glidesheath Slender (GSS6Fr, Terumo, Japan) or a standard 5 Fr sheath in Japanese and non-Japanese patients. METHODS AND RESULTS:The Radial Artery Patency and Bleeding, Efficacy, Adverse evenT (RAP and BEAT) trial randomized 1,836 patients undergoing TR coronary angiography and/or interventions to receive the GSS6Fr or the standard 5 Fr Glidesheath (GS5Fr, Terumo, Japan). Out of this study population, 1,087 were Japanese patients and 751 non-Japanese patients. The overall incidence of RAO was significantly higher in Japanese patients (3.6% vs. 1.2%, P = 0.002). Use of GSS6Fr was associated with higher rates of RAO than GS5Fr in Japanese patients (5% vs. 2.2%, P = 0.02) and with similar RAO rates in non-Japanese patients (1.3 vs. 1.1%, P = 1). The mean hemostasis time was significantly longer in Japanese patients (378 ± 253 vs. 159 ± 136 min, P < 0.001) and more Japanese patients had a hemostasis time of more than 6 hr (16.2% vs. 4.9%, P < 0.0001). Longer hemostasis time was an independent predictor of RAO (OR per additional hour 1.070, 95% CI 1.008-1.136, P = 0.03). CONCLUSIONS:Use of GSS6Fr was associated with a higher rate of RAO than a standard 5 Fr sheath in Japanese patients but not in non-Japanese patients. Whether improvement in post-procedural care and reduced hemostasis time could impact the incidence of RAO in Japanese patients should be further assessed.
PMID: 29451949
ISSN: 1522-726x
CID: 5221822

Percutaneous or surgical access for transfemoral transcatheter aortic valve implantation

Vora, Amit N; Rao, Sunil V
Transcatheter aortic valve implantation is an important therapeutic option for patients with symptomatic, severe aortic stenosis at increased risk for open surgical aortic valve replacement. Although a number of alternative vascular access sites have been developed, transfemoral access is overwhelmingly the dominant access strategy for this procedure. Access was achieved in the initial clinical experience primarily via surgical cutdown, but more recently, there has been increasing use of a fully percutaneous approach. This is likely driven by improvements in technology, more experience with large bore vascular closure devices (VCDs), and pressures to reduce hospital length of stay. This review will describe temporal trends of percutaneous versus surgical transfemoral access, identify the advantages and disadvantages of each approach, and describe the best practices for achieving safe transfemoral percutaneous access.
PMCID:6242926
PMID: 30505540
ISSN: 2072-1439
CID: 5222072

Thrombus Aspiration in Patients With High Thrombus Burden in the TOTAL Trial

Jolly, Sanjit S; Cairns, John A; Lavi, Shahar; Cantor, Warren J; Bernat, Ivo; Cheema, Asim N; Moreno, Raul; Kedev, Sasko; Stankovic, Goran; Rao, Sunil V; Meeks, Brandi; Chowdhary, Saqib; Gao, Peggy; Sibbald, Matthew; Velianou, James L; Mehta, Shamir R; Tsang, Michael; Sheth, Tej; Džavík, Vladimír
BACKGROUND:Routine thrombus aspiration in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) does not improve clinical outcomes. However, there is remaining uncertainty about the potential benefit in those patients with high thrombus burden, where there is a biological rationale for greater benefit. OBJECTIVES:The purpose of this study was to evaluate the benefit of thrombus aspiration among STEMI patients with high thrombus burden. METHODS:TOTAL (ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI) was a randomized trial of routine manual thrombectomy versus PCI alone in patients with STEMI (n = 10,732). High thrombus burden (Thrombolysis In Myocardial Infarction thrombus grade ≥3) was a pre-specified subgroup. RESULTS:The primary outcome of cardiovascular (CV) death, MI, cardiogenic shock, or heart failure was not different at 1 year with thrombus aspiration in patients with high thrombus burden (8.1% vs. 8.3% thrombus aspiration; hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.84 to 1.13) or low thrombus burden (6.0% vs. 5.0% thrombus aspiration; HR: 1.22; 95% CI: 0.73 to 2.05; interaction p = 0.41). However, among patients with high thrombus burden, stroke at 30 days was more frequent with thrombus aspiration (31 [0.7%] thrombus aspiration vs. 16 [0.4%] PCI alone, HR: 1.90; 95% CI: 1.04 to 3.48). In the high thrombus burden group, thrombus aspiration did not significantly improve CV mortality at 30 days (HR: 0.78; 95% CI: 0.61 to 1.01; p = 0.06) and at 1 year (HR: 0.88; 95% CI: 0.72 to 1.09; p = 0.25). Irrespective of treatment assignment, high thrombus burden was an independent predictor of death (HR: 1.78; 95% CI: 1.05 to 3.01). CONCLUSIONS:In patients with high thrombus burden, routine thrombus aspiration did not improve outcomes at 1 year and was associated with an increased rate of stroke. High thrombus burden is still an important predictor of outcome in STEMI. (A Trial of routine aspiration ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI [TOTAL]; NCT01149044).
PMID: 30261959
ISSN: 1558-3597
CID: 5221982

Length of stay following percutaneous coronary intervention: An expert consensus document update from the society for cardiovascular angiography and interventions

Seto, Arnold H; Shroff, Adhir; Abu-Fadel, Mazen; Blankenship, James C; Boudoulas, Konstantinos Dean; Cigarroa, Joaquin E; Dehmer, Gregory J; Feldman, Dmitriy N; Kolansky, Daniel M; Lata, Kusum; Swaminathan, Rajesh V; Rao, Sunil V
Since the publication of the 2009 SCAI Expert Consensus Document on Length of Stay Following percutaneous coronary intervention (PCI), advances in vascular access techniques, stent technology, and antiplatelet pharmacology have facilitated changes in discharge patterns following PCI. Additional clinical studies have demonstrated the safety of early and same day discharge in selected patients with uncomplicated PCI, while reimbursement policies have discouraged unnecessary hospitalization. This consensus update: (1) clarifies clinical and reimbursement definitions of discharge strategies, (2) reviews the technological advances and literature supporting reduced hospitalization duration and risk assessment, and (3) describes changes to the consensus recommendations on length of stay following PCI (Supporting Information Table S1). These recommendations are intended to support reasonable clinical decision making regarding postprocedure length of stay for a broad spectrum of patients undergoing PCI, rather than prescribing a specific period of observation for individual patients.
PMID: 29691963
ISSN: 1522-726x
CID: 5221862

Two-year mortality of primary angioplasty for acute myocardial infarction during regular working hours versus off-hours

Dharma, Surya; Dakota, Iwan; Sukmawan, Renan; Andriantoro, Hananto; Siswanto, Bambang Budi; Rao, Sunil V
BACKGROUND:Studies with short-term follow-up found higher mortality in patients with STEMI who underwent primary PCI during off-hours as compared to regular working hours. We analyzed the interaction between one and two-year survival of patients with STEMI who underwent primary PCI during regular working hours and off-hours in a tertiary care academic teaching hospital. METHODS:A total of 1126 STEMI patients treated with primary PCI between 2008 and 2013 were analyzed. Two-years follow-up were available in 941 (83%) patients. Multivariable survival analysis was used to estimate the relationship between treatment during off-hours versus regular hours and the incidence of all-cause mortality at 2-years follow-up. Logistic regression was used to calculate interaction p-values between time of admission and time (between ≤1 year and ≤2 year). RESULTS:At 2-years, the mortality rate of patients admitted during off-hours and regular hours was similar (15% vs. 19%; adjusted hazard ratio 0.77; 95% confidence interval 0.52-1.16). Of the 941 patients, those who admitted during off-hours (N = 717) had similar median door-to-device time (94 min vs. 91 min), final Thrombolysis In Myocardial Infarction 3 flow grade (93% vs. 91%) and use of dual antiplatelet within 24 h (96% vs. 98% respectively) as compared with regular hours admission (N = 224). There were no mortality difference observed between one year and two years (p interaction >0.05). CONCLUSION:In this analysis, the similar mortality observed at one year between patients with STEMI treated by primary PCI during off-hour and regular hour were maintained at two years.
PMID: 29730236
ISSN: 1878-0938
CID: 5221872

Ultrasound-guided versus palpation-guided radial artery catheterization in adult population: A systematic review and meta-analysis of randomized controlled trials

Moussa Pacha, Homam; Alahdab, Fares; Al-Khadra, Yasser; Idris, Amr; Rabbat, Firas; Darmoch, Fahed; Soud, Mohamad; Zaitoun, Anwar; Kaki, Amir; Rao, Sunil V; Kwok, Chun Shing; Mamas, Mamas A; Alraies, M Chadi
BACKGROUND:The radial artery (RA) is routinely used for both hemodynamic monitoring and for cardiac catheterization. Although cannulation of the RA is usually undertaken through manual palpation, ultrasound (US)-guided access has been advocated as a mean to increase cannulation success rates and to lower RA complications; however, the published data are mixed. We sought to evaluate the impact of US-guided RA access compared with palpation alone on first-pass success to access RA. METHODS AND RESULTS:Meta-analysis of 12 randomized controlled trials comparing US-guided with palpation-guided radial access in 2,432 adult participants was done. Hemodynamic monitoring was the most common reason for RA catheterization. Only 2 randomized controlled trials evaluated patients undergoing cardiac catheterization. Ultrasound-guided radial access was associated with increased first-attempt success rate (risk ratio [RR] 1.35, 95% CI 1.16-1.57]) and decreased failure rate (RR 0.52, 95% CI 0.32-0.87). There were no significant differences in the risk of hematoma (RR 0.43, 95% CI 0.27-1.06), the mean time to first successful attempt (mean difference 25.13 seconds, 95% CI -1.06 to 51.34) or to any successful attempt (mean difference -4.74 seconds; 95% CI -22.67 to 13.18) between both groups. CONCLUSIONS:Ultrasound-guided technique for RA access has higher first-attempt success and lower failure rate compared with palpation alone, with no significant differences in access site hematoma or time to a successful attempt. These findings support the routine use of US guidance for RA access.
PMID: 30077047
ISSN: 1097-6744
CID: 5221942