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Variation in practice and concordance with guideline criteria for length of stay after elective percutaneous coronary intervention

Din, Jehangir N; Snow, Thomas M; Rao, Sunil V; Klinke, W Peter; Nadra, Imad J; Della Siega, Anthony; Robinson, Simon D
BACKGROUND:Considerable variability remains as regards the appropriate and safe length of stay after elective PCI. We performed a survey of interventional cardiologists to identify current views on appropriate and safe length of stay after PCI. METHODS:We created an online survey using the commercially available SurveyMonkey application. This was sent to interventional cardiologists in the US, Canada and the UK with the assistance of the national interventional cardiology societies (SCAI, CAIC/CCS, BCIS/BCS) as well as being made available on the theheart.org website. RESULTS:505 interventional cardiologists responded, of which 237 were practicing in the US. Of those from the US, 52% were not aware of any guidelines for length of stay and 48% reported that their unit did not have a standard practice for length of stay. Same-day discharge after PCI was practiced as routine by 14% of cardiologists in the US versus 32% of cardiologists from Canada (P = 0.003) and 57% (P < 0.0001) from the UK. Amongst respondents, there was significant variation between respondents and divergence from published SCAI guidelines regarding appropriate length of stay for patient specific and procedural related clinical factors. CONCLUSIONS:There is considerable variation in practice patterns regarding length of stay after PCI. Whilst most cardiologists practice overnight observation, a significant minority utilize same-day discharge. There is also lack of familiarity with published guidelines. This variation and knowledge gap confirms an urgent need for updated guidelines and a concerted effort to educate cardiologists on appropriate post-PCI length of stay. © 2017 Wiley Periodicals, Inc.
PMID: 28371209
ISSN: 1522-726x
CID: 5221632

Effect of post-primary percutaneous coronary intervention bivalirudin infusion on net adverse clinical events and mortality: A comprehensive pairwise and network meta-analysis of randomized controlled trials

Shah, Rahman; Matin, Khalid; Rogers, Kelly C; Rao, Sunil V
OBJECTIVE:To compare the efficacies of various post-percutaneous coronary intervenetion (PCI) bivalirudin doses on net adverse clinical events (NACEs) and mortality. BACKGROUND:In primary PCI, lower risk of bleeding with bivalirudin (vs. unfractionated heparin [UFH]) is counterbalanced by an increased risk of acute stent thrombosis (ST). Several randomized clinical trials (RCTs) and a recent meta-analysis suggest that acute ST risk may be eliminated without compromising the bleeding benefit, but only if the full dose, not a low dose, of bivalirudin is continued post-PCI. However, it is not known whether this improved risk leads to lower rates of NACEs and mortality. METHODS:Scientific databases and Web sites were searched for RCTs. Trials were included if study patients were undergoing primary PCI for acute ST-segment elevation myocardial infarction and were randomly assigned to bivalirudin or UFH treatment. The bivalirudin arm was divided based on post-PCI bivalirudin dosage: The Biv-Full group received 1.75 mg/kg/h, the Biv-Low group, 0.25 mg/kg/h, and the Biv-No group, none. RESULTS:Six RCTs involving 16,842 patients were found. In pairwise meta-analysis, bivalirudin improved 30-day all-cause mortality by 35% and cardiac mortality by 32%, but did not yield a NACE rate better than that achieved with UFH. Subgroup analysis showed the Biv-Full group had a 46% lower NACE rate and 47% lower all-cause mortality than UFH. These effects were not seen in the other two groups. Network meta-analysis yielded similar results. At treatment ranking, the Biv-Full group yielded the best treatment efficacy. CONCLUSIONS:In primary PCI, full-dose bivalirudin infusion for 3-4 hr after PCI appeared to improve NACE rates compared to UFH. It also seemed to be the most effective strategy for improving cardiac mortality and all-cause mortality. © 2016 Wiley Periodicals, Inc.
PMID: 27862911
ISSN: 1522-726x
CID: 5224842

Transradial approach for coronary angiography and intervention in the elderly: A meta-analysis of 777,841 patients

Alnasser, Sami M; Bagai, Akshay; Jolly, Sanjit S; Cantor, Warren J; Dehghani, Payam; Rao, Sunil V; Cheema, Asim N
BACKGROUND:Studies showing an advantage of transradial approach (TR) for coronary angiography and intervention (PCI) compared to the transfemoral approach (TF) predominantly included a younger population. Therefore, we conducted a meta-analysis of published studies to determine the efficacy of TR in the elderly population. METHODS AND RESULTS/RESULTS:A comprehensive search identified 16 studies [3 randomized controlled studies, 13 observational] comprising 777,841 elderly patients undergoing PCI. TR was used in 99,201 patients and TF in 678,640 patients. The results from observational studies showed that TR was associated with a lower rate of vascular complications (0.4% vs. 0.8%, OR 0.36, 95% CI 0.30-0.44), stroke (0.3% vs. 0.4%, OR 0.81, 95% CI 0.66-1.0) and death (2.0% vs. 2.2%, OR 0.51, 95% CI 0.41-0.63). RCTs confirmed findings from observational studies for both significant reduction in vascular complications (2.7% vs. 7%, OR 0.37, 95% CI 0.23-0.60) and stroke (0.4% vs. 1.4%, OR 0.31, 95% CI 0.10-0.97) but showed no effect on mortality (3.3% vs. 2.8%, OR 1.20, 95% CI 0.69-2.09). However, among patients with ST elevation myocardial infarction (STEMI), TR was associated with a mortality benefit (5% vs. 7%, OR 0.48, 95% CI 0.25-0.90, p=0.02). Access site crossover rate was higher for TR compared to the TF approach (11% vs. 3%, p=0.0003) but there was no difference in contrast media use, procedure duration, fluoroscopy time and door to balloon time for STEMI. CONCLUSION/CONCLUSIONS:TR for PCI in the elderly is associated with a reduced risk of stroke, lower rate of vascular complications overall and a mortality benefit for patients presenting with STEMI. The access site cross rate for TR is higher compared to TF but remains acceptably low. TR should be the preferred strategy for PCI in the elderly to optimize clinical benefit in this high-risk group.
PMID: 27863361
ISSN: 1874-1754
CID: 5224852

Radial artery diameter does not correlate with body mass index: A duplex ultrasound analysis of 1706 patients undergoing trans-radial catheterization at three experienced radial centers

Dharma, Surya; Kedev, Sasko; Patel, Tejas; Rao, Sunil V; Bertrand, Olivier F; Gilchrist, Ian C
BACKGROUND:We examined whether the radial artery diameter is correlated with body mass index (BMI) in patients undergoing transradial catheterization. METHODS:1706 patients undergoing trans-radial catheterization at three experienced, high-volume, radial centers were analyzed. Radial and ulnar artery diameters were determined by ultrasound in the distal third of the forearm one day post procedure. Pearson correlation test was used to measure the relationship between continuous variables. RESULTS:Radial diameter was larger than the ulnar artery [median 2.8mm (interquartile range (IQR): 2.4-3.1mm) vs. median 2.4mm (IQR: 2.1-2.6mm), p<0.001]. Women had smaller radial and ulnar arteries compared to men [median 2.6mm (IQR: 2.3-2.9mm) vs. median 2.8 (IQR: 2.4-3.2mm), p<0.001 and median 2.2mm (IQR: 2.0-2.5mm) vs. median 2.5mm (IQR: 2.2-2.7mm), p<0.001, respectively]. There was no correlation between radial diameter and BMI (Pearson correlation=0.003, p=0.88 (2-sided)), but a strong linear correlation between the radial and ulnar artery diameter existed (Pearson correlation=0.48, p<0.001 (2-sided)). After adjustment for clinical variables including diabetes, gender, and age, female gender was associated with smaller radial diameter (<2.8mm) (odds ratio 1.72; 95% CI 1.40-2.12, p<0.001). CONCLUSIONS:No correlation was observed between radial artery diameter and BMI, although female gender was associated with smaller radial diameter. This suggests catheterization can be performed without anthropometric consideration, although it should be recognized women may have smaller radial arteries. As the diameter of the radial is larger than the ulnar artery, the radial should remain the default catheterization access-site.
PMID: 27865181
ISSN: 1874-1754
CID: 5224862

Hospital Readmission as a Transcatheter Aortic Valve Replacement Performance Measure: Too Soon? [Comment]

Swaminathan, Rajesh V; Rao, Sunil V
PMID: 28034847
ISSN: 1941-7632
CID: 5224882

Revascularization Strategies and Outcomes in Elderly Patients With Multivessel Coronary Disease

Posenau, J Trevor; Wojdyla, Daniel M; Shaw, Linda K; Alexander, Karen P; Ohman, E Magnus; Patel, Manesh R; Smith, Peter K; Rao, Sunil V
BACKGROUND:Balancing risks and benefits of revascularization in elderly patients with multivessel coronary artery disease (CAD) is challenging. The appropriate revascularization strategy for elderly patients with multivessel CAD is unclear. METHODS:We used the Duke Databank for Cardiovascular Disease to identify patients aged 75 years or more who had multivessel disease and treatment with percutaneous coronary intervention or coronary artery bypass graft surgery (CABG) within 30 days of the index catheterization between October 1, 2003, and June 30, 2013. The primary outcome was a composite of all-cause death, myocardial infarction, and coronary revascularization through latest follow-up. Associations between bare-metal stents (BMS), drug-eluting stents (DES), CABG, and outcomes were determined using multivariable Cox proportional hazards modeling, adjusting for potential confounders with CABG as the reference. Comparisons between BMS and DES were done using BMS as the reference. RESULTS:We identified 763 patients who met the criteria (BMS, n = 202; DES, n = 411; CABG, n = 150). The median age was 79 years (interquartile range, 76 to 82), and the median follow-up was 6.28 years. After adjustment, both BMS and DES were associated with a higher risk of the primary outcome. The BMS versus CABG hazard ratio was 1.58 (95% confidence interval: 1.15 to 2.19, p = 0.01). The DES versus CABG hazard ratio was 1.45 (95% confidence interval: 1.08 to 1.95, p = 0.01). The adjusted hazard ratio for DES versus BMS (0.92, 95% confidence interval: 0.71 to 1.19, p = 0.51) was not statistically significant. CONCLUSIONS:In this single-center analysis of 763 elderly patients with multivessel disease, CABG was associated with the best overall clinical outcomes, but was selected for a minority of patients. An adequately powered, randomized trial should be considered to define the best treatment strategy for this population.
PMID: 28109574
ISSN: 1552-6259
CID: 5224892

Lipid-lowering Therapy in Patients With High Cardiovascular Risk: Dose or Combination?

Roever, Leonardo; Biondi-Zoccai, Giuseppe; Rao, Sunil V
Cardiovascular disease is the leading cause of death in the world. Dyslipidemia, manifested by elevated low-density lipoprotein cholesterol (LDL-C) levels, is central to the development and progression of atherosclerosis. Dyslipidemia has become a primary target of intervention in strategies for the prevention of cardiovascular events. Therapeutic lifestyle changes, such as increased physical activity, weight loss, smoking cessation, and adoption of a healthier diet, are effectively reducing cardiovascular risk in primary and secondary prevention. The combination therapy lowered LDL-C levels and achieved the LDL-C target in patients with high cardiovascular risk.
PMID: 28190598
ISSN: 1879-114x
CID: 5224902

Comparison of a new slender 6 Fr sheath with a standard 5 Fr sheath for transradial coronary angiography and intervention: RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT), a randomised multicentre trial

Aminian, Adel; Saito, Shigeru; Takahashi, Akihiko; Bernat, Ivo; Jobe, Robert Lee; Kajiya, Takashi; Gilchrist, Ian C; Louvard, Yves; Kiemeneij, Ferdinand; Van Royen, Niels; Yamazaki, Seiji; Matsukage, Takashi; Rao, Sunil V
AIMS/OBJECTIVE:The 6 Fr Glidesheath Slender (GSS6Fr) is a recently developed thin-walled radial sheath with an outer diameter (OD) that is smaller than the OD of standard 6 Fr sheaths. The purpose of this trial was to clarify whether the use of this new slender sheath would result in similar rates of RAO to a standard 5 Fr sheath in unselected patients undergoing transradial (TR) coronary angiography and/or intervention, and to assess the relative importance of sheath size and haemostasis protocol on the rate of RAO. METHODS AND RESULTS/RESULTS:We conducted a randomised, multicentre, non-inferiority trial comparing the GSS6Fr against the standard GS5Fr in patients undergoing TR coronary angiography and/or intervention. Patients in each group were subsequently randomised to undergo patent haemostasis or the institutional haemostasis protocol. The primary endpoint was the occurrence of RAO at discharge. A total of 1,926 patients were randomised in 12 centres. The incidence of RAO was 3.47% with GSS6Fr compared with 1.74% with GS5Fr (risk difference 1.73%, 95% CI: 0.51-2.95%; pnon-inferiority=0.150). Patients randomised to patent haemostasis had a similar rate of RAO compared with institutional haemostasis (2.61% vs. 2.61%, p=1). There was no difference with regard to all secondary endpoints, including vascular access-site complications, local bleeding and spasm. CONCLUSIONS:In this large multicentre randomised trial, the GSS6Fr was associated with a low event rate for the primary endpoint (RAO), although non-inferiority to the GS5Fr was not met, due to a lower than expected rate of RAO in the GS5Fr group. As compared to institutional haemostasis, the use of patent haemostasis was not associated with a reduced rate of RAO.
PMID: 28218605
ISSN: 1969-6213
CID: 5224912

Costs Associated With Access Site and Same-Day Discharge Among Medicare Beneficiaries Undergoing Percutaneous Coronary Intervention: An Evaluation of the Current Percutaneous Coronary Intervention Care Pathways in the United States

Amin, Amit P; Patterson, Mark; House, John A; Giersiefen, Helmut; Spertus, John A; Baklanov, Dmitri V; Chhatriwalla, Adnan K; Safley, David M; Cohen, David J; Rao, Sunil V; Marso, Steven P
OBJECTIVES:The aim of this study was to examine the independent impact of various care pathways, including those involving transradial intervention (TRI) and same-day discharge (SDD) after elective percutaneous coronary intervention (PCI), on hospital costs. BACKGROUND:PCI is associated with costs of $10 billion annually. Alternative payment models for PCI are being implemented, but few data exist on strategies to reduce costs. Various PCI care pathways, including TRI and SDD, exist, but their association with costs and outcomes is unknown. METHODS:In total, 279,987 PCI patients eligible for SDD in the National Cardiovascular Data Registry CathPCI Registry linked to Medicare claims files were analyzed. Hospital costs in 2014 U.S. dollars were estimated using cost-to-charge ratios. Propensity scores for TRI and SDD, with propensity adjustment via inverse probability weighting, was performed. RESULTS:Of the 279,987 PCI procedures, TRI was used in 9.0% (13.5% of which were SDD), and SDD was used in 5.3% of cases (23.1% of which were TRI). TRI (vs. transfemoral intervention) was associated with lower adjusted costs of $916 (95% confidence interval [CI]: $778 to $1,035), as was SDD ($3,502; 95% CI: $3,486 to $3,902). The adjusted cost associated with TRI and SDD was $13,389 (95% CI: $13,161 to $13,607), while the cost associated with transfemoral intervention and non-same-day discharge was $17,076 (95% CI: $16,999 to $17,147), a difference of $3,689 (95% CI: $3,486 to $3,902; p < 0.0001). Shifting current practice from transfemoral intervention non-same-day discharge to TRI SDD by 30% could potentially save a hospital performing 1,000 PCIs each year $1 million and the country $300 million annually. CONCLUSIONS:Among Medicare beneficiaries, TRI with SDD was independently associated with fewer complications and lower in-hospital costs. These findings have important implications for changing the current PCI care pathways to improve outcomes and reduce costs.
PMID: 28231901
ISSN: 1876-7605
CID: 5224922

Comparative Efficacy of Coronary Revascularization Procedures for Multivessel Coronary Artery Disease in Patients With Chronic Kidney Disease

Roberts, John K; Rao, Sunil V; Shaw, Linda K; Gallup, Dianne S; Marroquin, Oscar C; Patel, Uptal D
Patients with chronic kidney disease (CKD) are at increased risk of cardiovascular disease and death, yet little data exist regarding the comparative efficacy of coronary revascularization procedures in CKD patients with multivessel disease. We created a cohort of 4,687 adults who underwent cardiac catheterization, had a serum creatinine value measured within 30 days, and had more than one vessel with ≥50% stenosis. We used Cox proportional hazard regression modeling weighted by the inverse probability of treatment to examine the association between 4 treatment strategies (medical management, percutaneous coronary intervention [PCI] with bare metal stent, PCI with drug-eluting stent, and coronary artery bypass grafting [CABG]) and mortality among patients across categories of estimated glomerular filtration rate; secondary outcome was a composite of mortality, myocardial infarction, or revascularization. Compared with medical management, CABG was associated with a reduced risk of death for patients of any nondialysis CKD severity (hazard ratio [HR] range 0.43 to 0.59). There were no significant mortality differences between CABG and PCI, except a decreased death risk in CABG-treated CKD patients (HR range 0.54 to 0.55). Compared with medical management and PCI, CABG was associated with a lower risk of death, myocardial infarction, or revascularization in nondialysis CKD patients (HR range 0.41 to 0.64). There were similar associations between decreased estimated glomerular filtration rate and increased mortality across all multivessel coronary artery disease patient treatment groups. When accounting for treatment propensity, surgical revascularization was associated with improved outcomes in patients of all CKD severities. A prospective randomized trial in CKD patients is required to confirm our findings.
PMCID:5392163
PMID: 28318510
ISSN: 1879-1913
CID: 5224932