Samir Pancholy

Prevention of radial artery occlusion-patent hemostasis evaluation trial (PROPHET study): a randomized comparison of traditional versus patency documented hemostasis after transradial catheterization.

Objective: The objective of this study was to evaluate the efficacy of hemostasis with patency in avoiding radial artery occlusion after transradial catheterization. Background: Radial artery occlusion is an infrequent but discouraging complication of transradial access. It is related to factors such as sheath to artery ratio and is less common in patients receiving heparin. Despite being clinically silent in most cases, it limits future transradial access. Patients and Methods: Four hundred thirty‐six consecutive patients undergoing transradial catheterization were prospectively enrolled in the study. Two hundred nineteen patients were randomized to group I, and underwent conventional pressure application for hemostasis. Two hundred seventeen patients were randomized to group II and underwent pressure application confirming radial artery patency using Barbeaus test. Radial artery patency was studied at 24 hr and 30 days using Barbeaus test. Results: Thirty‐eight patients had evidence of radial artery occlusion at 24 hr. Twenty patients had persistent evidence of radial artery occlusion at 1 month. Group II, with documented patency during hemostatic compression, had a statistically and clinically lower incidence of radial artery occlusion (59% decrease at 24 hr and 75% decrease at 30 days, P < 0.05), compared with patients in group I. Low body weight patients were at significantly higher risk of radial artery occlusion. No procedural variables were found to be associated with radial artery occlusion. Conclusion: Patent hemostasis is highly effective in reducing radial artery occlusion after radial access and guided compression should be performed to maintain radial artery patency at the time of hemostasis, to prevent future radial artery occlusion.

Transradial Approach for Coronary Angiography and Interventions: Results of the First International Transradial Practice Survey

OBJECTIVES The aim of this study was to evaluate practice of transradial approach (TRA). BACKGROUND TRA has been adopted as an alternative access site for coronary procedures. METHODS A questionnaire was distributed worldwide with Internet-based software. RESULTS The survey was conducted from August 2009 to January 2010 among 1,107 interventional cardiologists in 75 countries. Although pre-TRA dual hand circulation testing is not uniform in the world, >85% in the U.S. perform Allen or oximetry testing. Right radial artery is used in almost 90%. Judkins catheters are the most popular for left coronary artery angiographies (66.5%) and right coronary artery angiographies (58.8%). For percutaneous coronary intervention (PCI), 6-F is now standard. For PCI of left coronary artery, operators use standard extra back-up guiding catheters in >65% and, for right coronary artery 70.4% use right Judkins catheters. Although heparin remains the routine antithrombotic agent in the world, bivalirudin is frequently used in the U.S. for PCI. The incidence of radial artery occlusion before hospital discharge is not assessed in >50%. Overall, approximately 50% responded that their TRA practice will increase in the future (68.4% in the U.S.). CONCLUSIONS TRA is already widely used across the world. Diagnostic and guiding-catheters used for TRA remain similar to those used for traditional femoral approach, suggesting that specialized radial catheters are not frequently used. However, there is substantial variation in practice as it relates to specific aspects of TRA, suggesting that more data are needed to determine the optimal strategy to facilitate TRA and optimize radial artery patency after catheterization.

Randomized Trial of Primary PCI with or without Routine Manual Thrombectomy

BACKGROUND During primary percutaneous coronary intervention (PCI), manual thrombectomy may reduce distal embolization and thus improve microvascular perfusion. Small trials have suggested that thrombectomy improves surrogate and clinical outcomes, but a larger trial has reported conflicting results. METHODS We randomly assigned 10,732 patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI to a strategy of routine upfront manual thrombectomy versus PCI alone. The primary outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within 180 days. The key safety outcome was stroke within 30 days. RESULTS The primary outcome occurred in 347 of 5033 patients (6.9%) in the thrombectomy group versus 351 of 5030 patients (7.0%) in the PCI-alone group (hazard ratio in the thrombectomy group, 0.99; 95% confidence interval [CI], 0.85 to 1.15; P=0.86). The rates of cardiovascular death (3.1% with thrombectomy vs. 3.5% with PCI alone; hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P=0.34) and the primary outcome plus stent thrombosis or target-vessel revascularization (9.9% vs. 9.8%; hazard ratio, 1.00; 95% CI, 0.89 to 1.14; P=0.95) were also similar. Stroke within 30 days occurred in 33 patients (0.7%) in the thrombectomy group versus 16 patients (0.3%) in the PCI-alone group (hazard ratio, 2.06; 95% CI, 1.13 to 3.75; P=0.02). CONCLUSIONS In patients with STEMI who were undergoing primary PCI, routine manual thrombectomy, as compared with PCI alone, did not reduce the risk of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA class IV heart failure within 180 days but was associated with an increased rate of stroke within 30 days. (Funded by Medtronic and the Canadian Institutes of Health Research; TOTAL ClinicalTrials.gov number, NCT01149044.).

Transradial arterial access for coronary and peripheral procedures: executive summary by the Transradial Committee of the SCAI.

In response to growing U.S. interest, the Society for Coronary Angiography and Interventions recently formed a Transradial Committee whose purpose is to examine the utility, utilization, and training considerations related to transradial access for percutaneous coronary and peripheral procedures. With international partnership, the committee has composed a comprehensive overview of this subject presented herewith.

Best practices for transradial angiography and intervention: a consensus statement from the society for cardiovascular angiography and intervention's transradial working group.

Duke University Medical Center, Durham, North Carolina Stanford University Medical Center, Palo Alto, California Penn State Hershey Medical Center, Hershey, Pennsylvania Brigham and Women’s Hospital, Boston, Massachusetts Mayo Clinic, Rochester, Minnesota University of Illinois at Chicago/Jesse Brown VA Medical Center, Chicago, Illinois First Coast Heart and Vascular Center, Jacksonville, Florida G.V. (Sonny) Montgomery VA Medical CenterJackson, Mississippi. Stern Cardiovascular Foundation, Memphis, Tennessee Reid Heart Center at FirstHealth of the Carolinas, Pinehurst, North Carolina Deborah Heart & Lung Institute, Browns Mills, New Jersey Duke University Medical Center, Durham, North Carolina Lahey Clinic, Burlington, Massachusetts Geisinger Medical Center, Danville, Pennsylvania Apex Heart Institute, Seth N.H.L. Municipal Medical College, Ahmedabad, Gujarat, India The Wright Center for Graduate Medical Education, The Commonwealth Medical College, Scranton, Pennsylvania

The Learning Curve for Transradial Percutaneous Coronary Intervention Among Operators in the United States A Study From the National Cardiovascular Data Registry

Background— Adoption of transradial percutaneous coronary intervention (TRI) in the United States is low and may be related to challenges learning the technique. We examined the relationships between operator TRI volume and procedural metrics and outcomes. Methods and Results— We used CathPCI Registry data from July 2009 to December 2012 to identify new radial operators, defined by an exclusively femoral percutaneous coronary intervention approach for 6 months after their first percutaneous coronary intervention in the database and ≥15 total TRIs thereafter. Primary outcomes of fluoroscopy time, contrast volume, and procedure success were chosen as markers of technical proficiency. Secondary outcomes included in-hospital mortality, bleeding, and vascular complications. Adjusted outcomes were analyzed by using operator TRI experience as a continuous variable with generalized linear mixed models. Among 54 561 TRI procedures performed at 704 sites, 942 operators performed 1 to 10 procedures, 942 operators performed 11 to 50 procedures, 375 operators performed 51 to 100 procedures, and 148 operators performed 101 to 200 procedures. As radial caseload increased, more TRIs were performed in women, in patients presenting with ST-segment elevation myocardial infarction, and for emergency indications. Decreased fluoroscopy time and contrast use were nonlinearly associated with greater operator TRI experience, with faster reductions observed for newer (<30–50 cases) compared with more experienced (>30–50 cases) operators. Procedure success was high, whereas mortality, bleeding, and vascular complications remained low across TRI volumes. Conclusions— As operator TRI volume increases, higher-risk patients are chosen for TRI. Despite this, operator proficiency improves with greater TRI experience, and safety is maintained. The threshold to overcome the learning curve appears to be approximately 30 to 50 cases.

Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial

BACKGROUND Two large trials have reported contradictory results at 1 year after thrombus aspiration in ST elevation myocardial infarction (STEMI). In a 1-year follow-up of the largest randomised trial of thrombus aspiration, we aimed to clarify the longer-term benefits, to help guide clinical practice. METHODS The trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients with STEMI (TOTAL) was a prospective, randomised, investigator-initiated trial of routine manual thrombectomy versus percutaneous coronary intervention (PCI) alone in 10,732 patients with STEMI. Eligible adult patients (aged ≥18 years) from 87 hospitals in 20 countries were enrolled and randomly assigned (1:1) within 12 h of symptom onset to receive routine manual thrombectomy with PCI or PCI alone. Permuted block randomisation (with variable block size) was done by a 24 h computerised central system, and was stratified by centre. Participants and investigators were not masked to treatment assignment. The trial did not show a difference at 180 days in the primary outcome of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure. However, the results showed improvements in the surrogate outcomes of ST segment resolution and distal embolisation, but whether or not this finding would translate into a longer term benefit remained unclear. In this longer-term follow-up of the TOTAL study, we report the results on the primary outcome (cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure) and secondary outcomes at 1 year. Analyses of the primary outcome were by modified intention to treat and only included patients who underwent index PCI. This trial is registered with ClinicalTrials.gov, number NCT01149044. FINDINGS Between Aug 5, 2010, and July 25, 2014, 10,732 eligible patients were enrolled and randomly assigned to thrombectomy followed by PCI (n=5372) or to PCI alone (n=5360). After exclusions of patients who did not undergo PCI in each group (337 in the PCI and thrombectomy group and 331 in the PCI alone group), the final study population comprised 10,064 patients (5035 thrombectomy and 5029 PCI alone). The primary outcome at 1 year occurred in 395 (8%) of 5035 patients in the thrombectomy group compared with 394 (8%) of 5029 in the PCI alone group (hazard ratio [HR] 1·00 [95% CI 0·87-1·15], p=0·99). Cardiovascular death within 1 year occurred in 179 (4%) of the thrombectomy group and in 192 (4%) of 5029 in the PCI alone group (HR 0·93 [95% CI 0·76-1·14], p=0·48). The key safety outcome, stroke within 1 year, occurred in 60 patients (1·2%) in the thrombectomy group compared with 36 (0·7%) in the PCI alone group (HR 1·66 [95% CI 1·10-2·51], p=0·015). INTERPRETATION Routine thrombus aspiration during PCI for STEMI did not reduce longer-term clinical outcomes and might be associated with an increase in stroke. As a result, thrombus aspiration can no longer be recommended as a routine strategy in STEMI. FUNDING Canadian Institutes of Health Research, Canadian Network and Centre for Trials Internationally, and Medtronic Inc.

Sex differences in short-term and long-term all-cause mortality among patients with ST-segment elevation myocardial infarction treated by primary percutaneous intervention: a meta-analysis.

IMPORTANCE Although outcomes in patients with ST-segment elevation myocardial infarction (STEMI) have improved in the past 2 decades, a sex disparity exists in survival, with women having higher mortality than men. OBJECTIVE To conduct a meta-analysis of observational studies that examined differences in mortality by sex in patients with STEMI treated with primary percutaneous coronary intervention (PPCI). DATA SOURCES MEDLINE, EMBASE, Cochrane central, and electronic databases were searched for relevant studies in all languages and without time restriction. STUDY SELECTION Studies were included if (1) they studied patients who presented with STEMI, (2) primary percutaneous coronary intervention (PPCI) was the treatment for STEMI, (3) PPCI was performed within 12 hours of symptom onset, and (4) sex-specific in-hospital and/or 1-year mortality were reported. DATA EXTRACTION AND SYNTHESIS Two investigators independently reviewed retrieved citations and assessed eligibility. Discrepancies were resolved by consensus. Quality of included studies was assessed using Newcastle-Ottawa Quality Assessment Scale for cohort studies. Data were pooled using a random-effects model. MAIN OUTCOMES AND MEASURES Sex-specific in-hospital and 1-year all-cause mortality. Risk ratios (RRs) of mortality were used for these 2 time points, if reported. RESULTS Of the 149 studies identified, 35 met inclusion criteria, representing 18 555 women and 49 981 men. In the unadjusted analyses, women were at a higher risk for in-hospital (RR, 1.93; 95% CI, 1.75-2.14 [P < .001, I2 = 14%]) and 1-year all-cause mortality (RR, 1.58; 95% CI, 1.36-1.84 [P < .001, I2 = 51%]) compared with men. However, when adjusted RRs were used, the association between women and higher risk of all-cause mortality was attenuated but still significantly elevated for in-hospital mortality (RR, 1.48; 95% CI, 1.07-2.05 [P = .02, I2 = 56%]), but the higher risk for 1-year mortality in women was no longer significant (RR, 0.90; 95% CI, 0.69-1.17 [P = .42, I2 = 58%]). CONCLUSIONS AND RELEVANCE An increased mortality in women with STEMI treated with PPCI was detected in this large meta-analysis but is likely confounded by baseline cardiovascular risk factors and the differences in clinical profile of male and female patients with STEMI. Intensive cardiovascular risk modification efforts in women may help to reduce this sex disparity.

Effect of duration of hemostatic compression on radial artery occlusion after transradial access

To evaluate the effect of duration of hemostatic compression on the incidence of radial artery occlusion (RAO) after transradial coronary intervention. Background: RAO occurs in 2–10% of patients after transradial access. The effect of duration of hemostatic compression on occurrence of RAO is unknown.

Prognostic implications of normal exercise tomographic thallium images in patients with angiographic evidence of significant coronary artery disease

This study examines the prognostic implications of normal exercise tomographic thallium images in medically treated patients with angiographic evidence of coronary artery disease (CAD). There were 97 patients aged 60 +/- 10 years; 52 had 1-, 30 had 2-, and 15 had 3-vessel CAD (> or = 50% diameter stenosis). The exercise test was submaximal in 51 patients (53%); ST-segment depression during exercise occurred in 20 patients (21%), and angina during exercise occurred in 23 patients (24%). Most patients (71%) were receiving antianginal therapy. During a mean follow-up of 32 months, only 3 patients had cardiac events: 2 died of cardiac causes and 1 had nonfatal myocardial infarction (event rate 1.1%/year). None of those 3 patients had positive ST response during exercise. Thus, medically treated patients with CAD (including those with multivessel CAD) have a benign prognosis in the presence of normal exercise thallium images. These results have important implications in patient management and cost of health delivery.