Femoral or Radial Approach in Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial.

OBJECTIVES: The aim of this study was to compare transradial access (TRA) with transfemoral access (TFA) for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: TRA reduces the risk for vascular access complications but may make complex PCI, such as CTO PCI, more challenging. METHODS: FORT CTO (Femoral or Radial Approach in the Treatment of Coronary Chronic Total Occlusion) (NCT03265769) was a prospective, noninferiority, randomized controlled study of TRA vs TFA for CTO PCI. The primary study endpoint was procedural success, defined as technical success without any in-hospital major adverse cardiovascular events. The secondary study endpoint was major access-site complications. RESULTS: Between 2017 and 2021, 610 of 800 patients referred for CTO PCI at 4 centers were randomized to TRA (n = 305) or TFA (n = 305). Mean J-CTO (Multicenter CTO Registry in Japan) (2.1 ± 0.1 vs 2.2 ± 0.1; P = 0.279), PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) (1.3 ± 0.9 vs 1.1 ± 1.0; P = 0.058) and PROGRESS CTO complication (2.4 ± 1.8 vs 2.3 ± 1.8; P = 0.561) scores and use of the retrograde approach (11% vs 14%; P = 0.342) were similar in the TRA and TFA groups. TRA was noninferior to TFA for procedural success (84% vs 86%; P = 0.563) but had fewer access-site complications (2.0% vs 5.6%; P = 0.019). There was no difference between TFA and TRA in procedural duration, contrast volume, or radiation dose. CONCLUSIONS: TRA was noninferior to TFA for CTO PCI but had fewer access-site complications.

Ankaferd blood stopper as a new strategy to avoid early complications after transradial procedures: A randomized clinical trial.

BACKGROUND: We planned a three arm randomized study to evaluate the safety and efficacy of a new blood stopper, Ankaferd blood stopper (ABS) along with short-time compression, compared to either short-time compression with conventional sterile gauzes (CSG) or with a TR band after transradial (TRA) procedures. METHODS: The Ankaferd blood stopper as a new strategy to avoid early complications. After transradial procedures (ABS transradial) trial is designed in a prospective, randomized, placebo-controlled fashion and registered with http://clinicaltrials.gov (NCT02982733). Six hundred and thirty patients were randomized into three arms in a 1:1:1 fashion corresponding to three different strategies of patent hemostasis techniques after diagnostic or interventional catheterization. RESULTS: One (0.49%) patient in the CSG group and one patient (0.48%) in the TR Band group developed RAO at the end of the hemostasis, compared with 0 (0%) in the ABS group. At 30 days follow-up none of the groups had any patients with RAO. As a secondary end-points the difference was not statistically significant regarding hematoma among the three groups (P = 0.70). Bleeding during deflation of the TR Band or removal of the elastic bandage occurred in 55 patients (26.96%) in the CSG group and in 56 (27.31%) patients in the TR Band group compared to 19 patients (9.40%) in the ABS group (P < 0.001). CONCLUSION: Ankaferd blood stopper is a promising device for use in patent hemostasis, with no evidence on RAO at short-term or long term and with reduced risk of re-bleeding at the end of hemostasis.

Rise of serum troponin levels following uncomplicated elective percutaneous coronary interventions in patients without clinical and procedural signs suggestive of myocardial necrosis.

INTRODUCTION: The new definition of periprocedural myocardial infarction (type 4a MI) excludes patients without angina and electrocardiographic or echocardiographic changes suggestive of myocardial ischemia even though significant serum troponin elevations occur following percutaneous coronary intervention (PCI). AIM: To evaluate the incidence and predictors of serum troponin rise following elective PCI in patients without clinical and procedural signs suggestive of myocardial necrosis by using a high-sensitivite troponin assay (hsTnT). MATERIAL AND METHODS: Three hundred and four patients (mean age: 60.8 ±8.8 years, 204 male) undergoing elective PCI were enrolled. Patients with periprocedural angina, electrocardiographic or echocardiographic signs indicating myocardial ischemia or a visible procedural complication such as dissection or side branch occlusion were excluded. Mild-moderate periprocedural myocardial injury (PMI) and severe PMI were defined as post-PCI (12 h later) elevation of serum hsTnT concentrations to the range of 14-70 ng/l and > 70 ng/l, respectively. RESULTS: The median pre-procedural hsTnT level was 9.7 ng/l (interquartile range: 7.1-12.2 ng/l). Serum hsTnT concentration elevated (p < 0.001) to 19.4 ng/l (IQR: 12.0-38.8 ng/l) 12 h after PCI. Mild-moderate PMI and severe PMI were detected in 49.3% and 12.2% of patients, respectively. Post-procedural hsTnT levels were significantly higher in multivessel PCI, overlapping stenting, predilatation and postdilatation subgroups. In addition, post-procedural hsTnT levels were correlated (r = 0.340; p < 0.001) with the stent lengths. CONCLUSIONS: High-sensitivite troponin measurements indicate a high incidence of PMI even though no clinical or procedural signs suggestive of myocardial ischemia exist. Multivessel PCI, overlapping stenting, predilatation, postdilatation and longer stent length are associated with PMI following elective PCI.

A New Specific Device in Transcatheter Prosthetic Paravalvular Leak Closure: A Prospective Two-Center Trial.

BACKGROUND: This study sought to compare various outcomes among a new specifically designed transcatheter paravalvular leak closure (TPVLC) device and the devices that are being utilized off-label. METHODS: Between April 2012 and January 2015, in a prospective two-center study, 52 patients who needed surgical reintervention due to a hemodynamically significant prosthetic paravalvular leak were studied. This study population was divided into two groups. Group I was composed of 32 patients who underwent paravalvular leak (PVL) closure with the currently available devices that are being utilized off-label, while group II consisted of 20 patients who were treated with the new specifically designed Occlutech PVL device. RESULTS: Demographic and clinical variables indicated a higher rate of atrial fibrillation (P = 0.027) and chronic obstructive airway disease (P = 0.009) in group II. The apical approach was the most commonly used intervention route used for group II (P = 0.019). The procedural success rate was 100% (29 of 29 leaks) in group II while the rate was 92% (39 of 42 leaks) in group I. However, more secondary events were observed in group I, but they did not reach statistical significance (8 vs. 1, P = 0.064). CONCLUSIONS: With its high procedural success rate and encouraging outcome results, the Occlutech device seems to satisfy the expectations of a specifically designed PVL closure device. © 2016 Wiley Periodicals, Inc.

Comparison of Effects of Low- versus High-Dose Heparin on Access-Site Complications during Transradial Coronary Angiography: A Double-Blind Randomized Study.

OBJECTIVES: Although heparin is highly effective in reducing the rate of radial artery occlusion after transradial catheterization, the optimal heparin dose is still controversial. The aim of this study was to evaluate the efficacy and safety of two different heparin doses during transradial coronary angiography. METHODS: 490 consecutive patients undergoing transradial coronary angiography were prospectively enrolled into this double-blind randomized trial. A total of 202 patients enrolled in the low-dose (LD; 2,500 U of heparin) group and 202 patients enrolled in the high-dose (HD; 5,000 U of heparin) group were included in the final analysis. The primary endpoint of the study was radial artery occlusion. Bleeding and hematomas were the secondary outcome measures. RESULTS: At day 7, radial artery occlusion occurred in 5.9% of the patients in the LD group and in 5.4% of the patients in the HD group (p = 0.83). Bleeding during deflation of the transradial band occurred in 6.4% of the patients in the LD group and in 18.3% of the patients in the HD group; the difference was statistically significant (p < 0.001). Higher-dose heparin was found to be an independent predictor of bleeding (p = 0.007). CONCLUSION: A lower dose of heparin (i.e. 2,500 U) decreases bleeding during transradial band deflation without an increase in radial artery occlusion.

Impact of increased admission lipid levels on periprocedural myocardial injury following an elective percutaneous coronary intervention.

OBJECTIVE: Periprocedural myocardial injury (PMI) is known to be a predictor of in-hospital cardiac events and long-term adverse outcomes following a percutaneous coronary intervention (PCI). We aimed to evaluate the correlation between preprocedural serum lipid levels and PMI in patients undergoing elective PCI. PATIENTS AND METHODS: The final study group included 195 patients (60.1±0.7 years old, 68 women and 127 men). Serum high-sensitive troponin T (hscTnT) concentrations were measured immediately before PCI and 12 h after PCI. Serum total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), and triglyceride (TG) levels were determined immediately before PCI. Serum hscTnT concentrations were adjusted for the clinical and procedural characteristics of the patients using the weighted least-square regression analysis. RESULTS: The average preprocedural hscTnT concentration was 8.1±0.2 ng/l. The average serum hscTnT concentration increased to 34.1±2.8 ng/l (P<0.001) 12 h after PCI. Postprocedural hscTnT concentrations were correlated positively to serum concentrations of TC (r=0.435; P<0.001), LDL-C (r=0.349; P<0.001), and TG (r=0.517; P<0.001). There was also a positive correlation (r=0.205; P<0.01) between postprocedural hscTnT and lesion length. Mild-moderate PMI (postprocedural hscTnT≥14 to <70 ng/l) and severe PMI (postprocedural hscTnT≥70 ng/l) were observed in 122 (48.7%) and 27 (13.9%) patients, respectively. The patients with severe PMI had higher serum TC (P<0.001), LDL-C (P<0.001), and TG (P<0.001) concentrations. CONCLUSION: The present study indicates that increased preprocedural TC, LDL-C, and TG serum levels are associated with PMI and its severity following elective PCI.

The long-term incidence and predictors of radial artery occlusion following a transradial coronary procedure.

BACKGROUND: Radial artery occlusion (RAO) is an infrequent complication of transradial coronary procedures (TRA). To our knowledge, there is no satisfactory data regarding the late term incidence and predictors of RAO in the literature. Our aim was to establish the long-term incidence of radial artery occlusion and investigate its predictors. METHODS: This was a single center prospective study. A total number of 409 consecutive patients undergoing their first TRA were recruited. Clinical and procedural data were all recorded. Doppler ultrasound examination was performed at 6-15 months following the intervention. RESULTS: RAO was detected in 67 patients and 342 patients maintained radial artery patency. The overall RAO incidence was 16.4% at late term. Patients with RAO were younger than the patients with patent radial arteries (55.9 ± 9.7 vs. 59.1 ± 9.4 years, p = 0.014). The incidence of RAO in hypertensive patients (9.8%) was lower (p < 0.001) than the observed incidence (23%) in non-hypertensive patients. RAO group had higher rate (28%, p = 0.027) of post--procedural access site pain. Regression analysis revealed that hypertension was negative while post-procedural access site pain was positive independent predictors for RAO. In addition, the relative risk for RAO also increased significantly (p < 0.001) when the ratio of sheath/artery diameter (S/A) was > 1. CONCLUSIONS: The present study reveals that the long-term incidence of RAO is 16.4%. Hypertension, post-procedural access site pain and S/A ratio > 1 are independent predictors of RAO at late term.

Incidence and predictors of radial artery spasm at the beginning of a transradial coronary procedure.

OBJECTIVES: Our aim was to establish the frequency of radial artery spasm (RAS) and its predictors at the beginning of a transradial approach (TRA). METHODS: This was a single-center prospective study. A total of 1,722 consecutive patients undergoing their first transradial coronary procedure were recruited. After radial artery puncture, a hydrophilic sheath was used to complete arterial puncture, then 500 µg glycerol trinitrate and 2.5 mg verapamil were injected into radial artery along the sheath. After retrograde radial arteriography spasm was defined angiographically as a stenosis greater than 25%. Patient demographics, procedural data such as total procedural duration, the number of catheters and guidewires used, the amount of contrast media usage, dose area product (DAP) and fluoroscopy time, and vascular complications were recorded. RESULTS: The overall spasm incidence was 10.3%. The procedural success rate was lower in patients with spasm than in patients without spasm (80% vs. 95.7%, P < 0.001). The patients with spasm were older (mean age 63.9 ± 9.4 years vs. 60.0 ± 11.2 years, P < 0.001) and more commonly female (51.3% vs. 34.4%, P < 0.001). Spasm was more common in hypertensive patients (66% vs. 56%, P < 0.009). Surprisingly, smoking was less common in patients with spasm (17% vs. 29%, P < 0.001). Multiple logistic regression analysis showed that female gender (OR = 1,524, 95% CI: 1.033-2.248, P = 0.034) was the only independent predictor of RAS at the beginning of the procedure. CONCLUSIONS: The incidence of RAS was 10,3%, and female gender was the sole independent predictor of RAS at the very beginning of the procedure in patients undergoing a TRA.

Arterial anatomic variations and its influence on transradial coronary procedural outcome.

OBJECTIVES: Our aim was to establish the frequency of arterial anatomic variations and its relation to coronary procedural outcome in patients undergoing a first transradial coronary procedure. METHODS: This was a single center prospective study. A total of 1,446 consecutive patients undergoing their first transradial coronary procedure were recruited. Retrograde radial arteriography was performed to define radial artery anatomy. If the operator encountered serious problems during crossing the subclavian-aortic truncus, retrograde subclavian arteriography was also performed. Patient demographics; procedural data such as: total procedural duration, the number of catheters and guidewires used, the amount of contrast media usage, dose area product (DAP), and fluoroscopy time; and vascular complications were recorded. RESULTS: Anatomic variations were noted in 270 patients (18.6%), and these patients were significantly older (mean age 64.4 ± 10.4 vs. 59.2 ± 10.8 years, P < 0.001) and more commonly female (46% vs. 33%, P < 0.001) with significantly higher procedural failure rates (8.8% vs. 5.6%, P = 0.006). In addition, procedural duration (P < 0.001) and fluoroscopy time (P < 0.001) were statistically longer in patients with anatomic variations. Anatomic variations also had an adverse impact on the amount of contrast agent usage (63.9 ± 28.3 mL vs. 59.1 ± 25.3 mL, P = 0.006) and minor vascular complication rate (P = 0.007). CONCLUSIONS: This study indicates that anatomic variation of the arterial path has an adverse impact on transradial coronary procedural outcome.

A randomized study comparing the effectiveness of right and left radial approach for coronary angiography.

OBJECTIVES: Our aim was to compare the effectiveness between right radial approach (RRA) and left radial approach (LRA) by means of a randomized study in a large unselected patient population undergoing diagnostic coronary angiography. METHODS: Totally, 1,000 patients were randomized to undergo to RRA (n = 500) or LRA (n = 500). Procedure success was defined as coronary angiography completed with the initial radial artery approach without changing to another route. Performance of the procedure: Total procedural duration, the number of catheters and guidewires used were recorded. Safety of the procedure: The parameters collected for radiation exposure were dose area product (DAP) and fluoroscopy time. RESULTS: The percentage of success was not different between the two aproaches (LRA, 94.0%; RRA,93.8%; P = 0.96). The crossover rate to femoral was low, accounting for 38 cases (3.8%), without differences between RRA and LRA (20 and 18 cases, respectively, P > 0.05). An almost triple incidence of operator-reported subclavian tortuosity in the RRA compared with LRA was observed (44 cases vs. 15 cases, P < 0.001). With respect to the total procedural duration there was no difference between those two aproaches (LRA, 8.54 ± 4.09 min vs. RRA, 8.63 ± 5.20; P = 0.772). However, the fluoroscopy time was significantly shorter via the LRA compared with RRA (2.76 ± 2.00 min vs. 3.08 ± 2.62 min; P = 0.029). CONCLUSIONS: LRA for coronary angiography is associated with the same success rate and procedural duration time compared with RRA. However, the fluoroscopy time is significantly shorter in favor of LRA.

Comparison of primary percutaneous coronary intervention and streptokinase for acute isolated inferior ST elevation myocardial infarction with a predicted low risk profile.

BACKGROUND: Primary percutaneous coronary intervention (PCI) is the treatment of choice for acute myocardial infarction, especially for high-risk patients, but the data for low-risk patients are conflicting. A very low-risk subgroup of acute inferior myocardial infarction can be identified by electrocardiographic and clinical criteria during admission. We aimed to compare the outcomes of primary PCI and streptokinase treatment in this subgroup, which has not been evaluated separately before. MATERIAL/METHODS: We retrospectively analyzed in-hospital and 10-month follow-up outcomes of 97 patients with inferior acute myocardial infarction and clinical and electrocardiographic criteria predicting low risk who have been treated with primary PCI or streptokinase. RESULTS: Forty-eight patients received streptokinase, and 49 had undergone primary PCI. Both during the in-hospital period and follow-up, the groups did not differ in the end points of death, reinfarction, or stroke (in-hospital: 2.1% versus 4.1%, P=.57; follow-up: 8.9% versus 8.9%, P=1.000). Length of hospital stay was longer in the streptokinase group (6.5+/-2.5 versus 9.1+/-3.7 days, P=.001). Rate of repeat revascularization was reduced in the PCI group at 10 months (28.9% versus 55.6%, P=.002). CONCLUSIONS: When streptokinase and primary PCI are compared in isolated inferior acute myocardial infarction patients with a low-risk profile, there are no differences for in-hospital and long-term rates of death, reinfarction, or stroke. Primary angioplasty reduces the length of initial hospital stay, and reduces repeat admissions by decreasing the need for subsequent revascularization procedures. Large-scale studies are needed to reach a final conclusion.

Comparison of left ventricular contractility in pressure and volume overload: a strain rate study in the clinical model of aortic stenosis and regurgitation.

OBJECTIVE: The aim of this study is to compare the impact of two different loading conditions on myocardial contractility in asymptomatic patients with normal EF by using stain rate imaging (SRI). METHODS: A total of 27 patients with severe aortic regurgitation (mean age 50 ± 11 years) and 25 patients with severe aortic stenosis (mean age 53 ± 15 years) were prospectively recruited. Fifteen healthy subjects (mean age 50 ± 6 years) were enrolled as the control group. For the evaluation myocardial contractility, longitudinal LV function was chosen and, midventricular segment shortening was analyzed for the septum, LV lateral wall from apical four-chamber view and for the anterior, inferior wall from apical two-chamber view. RESULTS: Longitudinal peak systolic strain rate values of each segment derived from analysis of a total of 804 segments were significantly decreased in the patients population (P < 0.001). Global longitudinal peak systolic strain rate was also significantly decreased in aortic stenosis and regurgitation compared to the control group (-1 ± 0.5, -0.9 ± 0.3, and -1.6 ± 0.3, P = 0.001). As far as the comparison between patients with aortic stenosis and aortic regurgitation, neither global strain rate nor strain rate for each wall was found to be different. CONCLUSION: We conclude that longitudinal LV function is reduced in both pressure and volume overload, and both of this overload patterns are equally harmful to the ventricle.

Prediction of cardiovascular mortality in patients with ST-elevation myocardial infarction after primary percutaneous coronary intervention.

OBJECTIVES: We analyzed a large patient group to develop a clinical risk score that could be applied to patients after primary percutaneous coronary intervention (PCI). METHODS: We reviewed 2529 consecutive patients treated with primary PCI for ST-elevation myocardial infarction between 2003 and 2008. All clinical, angiographic and follow-up data were retrospectively collected. Independent predictors of in-hospital cardiovascular mortality were determined by multivariate Cox regression analysis in all study patients. RESULTS: Five variables (Killip class 2/3, unsuccessful procedure, contrast-induced nephropathy, diabetes mellitus, and age >70 years) were selected from the initial multivariate model. Each of them was weighted with 1 point according to their respective odds ratio for in-hospital mortality and then total risk score was calculated for each patient with a range of 0-5 points. For simplicity, four strata of risk were defined (low risk, score 0; intermediate risk, score 1; high risk, score 2 and very high risk, score > or =3). Each risk strata had a strong association with in-hospital cardiovascular mortality (P<0.001 for trend). Moreover, among survivors after an in-hospital period, our risk score continued to be a powerful predictor of long-term mortality (P<0.001 for trend). CONCLUSION: In patients treated with primary PCI, a risk score, which was developed from five risk factors readily available after intervention, may be useful to predict in-hospital and long-term cardiovascular mortality.

The outcome of primary percutaneous coronary intervention for stent thrombosis causing ST-elevation myocardial infarction.

BACKGROUND: There are very few scientific data about the effectiveness of primary percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarction (STEMI) due to stent thrombosis (ST). The purpose of the present study is to investigate the efficacy and outcome of primary PCI for STEMI due to ST in the largest consecutive patient population with ST reported to date. METHODS: A total of 2,644 consecutive STEMI patients undergoing primary PCI were retrospectively enrolled into the present study. The primary end point of this study was successful angiographic reperfusion defined as postprocedural Thrombolysis In Myocardial Infarction grade III flow. The secondary end points were cardiovascular death and reinfarction. RESULTS: Stent thrombosis was the cause of STEMI in 118 patients (4.4%). In patients with ST, angiographic success (postprocedural Thrombolysis In Myocardial Infarction grade III flow) was worse than in patients with de novo STEMI (76.3% vs 84.8%, P = .01). Patients with ST had significantly higher incidence of in-hospital cardiovascular mortality than patients with de novo STEMI (10.2% vs 5.3%, P = .02). In-hospital reinfarction rate was similar in both groups. In addition, long-term (mean 22 months) cardiovascular mortality and reinfarction rates were significantly higher in patients with ST compared with those without (17.4% vs 10.5%, P = .02 and 15.6% vs 9.5%, P = .03, respectively). CONCLUSIONS: Primary PCI for treatment of ST is less effective, and these patients are at increased risk for in-hospital and long-term mortality compared with patients undergoing primary PCI due to de novo STEMI.