Influence of a long-term proctoring process on the effectiveness of chronic total occlusion percutaneous coronary interventions.

BACKGROUND: Despite the complexity of the chronic total occlusion (CTO) percutaneous coronary intervention (PCI) procedures and unsatisfactory results in centers with low volume experience, the practice of training and certifying operators is not a routine. AIMS: The study aimed to identify factors influencing the effectiveness and complications of PCI CTOs during a proctoring program. METHODS: The study group consisted of 194 consecutive patients (226 PCI CTOs) as part of the proc-toring program. The relationships between clinical and treatment parameters and the experience gained along with the duration of the proctoring program on the effectiveness and safety of the procedure were assessed. RESULTS: The multivariable analysis showed an independent effect of CTO morphology (odds ratio [OR], 0.38; 95% confidence interval [CI], 0.21-0.71; P <0.01) and an independent effect of increasing operator's experience (OR, 2.62; 95% CI, 1.24-5.60; P = 0.01) on the effectiveness of the procedure. The increase in the efficiency of the PCI CTO, related to the treatment experience gained during the program, was observed especially in the first 50 procedures, treatment effectiveness increased from 55% to 72% (P <0.05). The success of procedures was higher in months when ≥3 procedures were performed (75% vs. 52%; P <0.001). Periprocedural complications occurred in 11 patients (4.9%). In the multivariable analysis, no independent factors influencing the risk of complications were identified. CONCLUSIONS: The effectiveness of PCI CTO depended on lesion complexity and broadening oper-ator's experience. No independent factors affecting the risk of complications were identified. The number of >50 procedures under the proctor's supervision should be considered in designing teaching programs.

Influence of heart rate on FFR measurements: An experimental and clinical validation study.

BACKGROUND: Functional lesion assessment in stable coronary disease is considered the gold standard. The result of fractional flow reserve (FFR) in stable coronary disease is often a decision-maker for patient qualification. Taking into account the paramount position of FFR, it is crucial to acknowledge and reduce all potential bias. AIMS: In the present study, we quantified the influence of elevated HR on FFR results using a preclinical model and then validated the results in a clinical setting. METHODS AND RESULTS: The relationship between FFR and HR was first explored experimentally in a porcine model. A clinical validation study was conducted in patients with isolated moderate lesions in the left anterior descending artery (LAD) or right coronary artery (RCA). In both the experimental and clinical arms, FFR was measured at resting HR and with pacing at 100, 130, 160, and 180 (for pigs) beats per minute. In the porcine model and in the clinical settings, a significant correlation between FFR and HR was confirmed in the LAD (r = 0.89, p < .0001; r = 0.53, p = .00002), but not in the RCA (r = -0.19, p = .5; r = 0.14, p = .3). Post hoc analyses revealed that the FFR values in the LAD at 130/min and above tended to be significantly different from the baseline HR. CONCLUSIONS: The results of this study indicate that in an experimental setting, tachycardia might be responsible for an overestimation of FFR results in LAD lesions.

Impact of Routine Invasive Physiology at Time of Angiography in Patients With Multivessel Coronary Artery Disease on Reclassification of Revascularization Strategy: Results From the DEFINE REAL Study.

OBJECTIVES: This study sought to prospectively assess the impact of routine invasive physiology at the time of angiography on reclassification of therapeutic management of multivessel disease (MVD) patients, and to assess how implementation of instantaneous wave-free ratio (iFR) alters the process. BACKGROUND: Routine invasive physiology in intermediate coronary lesions at the time of diagnostic angiography, primarily in patients with single-vessel disease and using fractional flow reserve (FFR), reclassifies coronary revascularization management in 26% to 44% of patients. The role of invasive physiology in patients with MVD is unclear. METHODS: In 18 centers, 484 patients undergoing diagnostic angiography disclosing MVD with lesions >40% by visual assessment were included. Investigators were asked to prospectively define their initial management strategy based on angiography and clinical information. Invasive physiology (FFR or iFR driven) was then performed and final strategy defined. Initial and final vessel, patient, procedural, and overall management were described. Reclassification was defined as the difference between initial and final strategy. RESULTS: The majority of patients were clinically stable (82.2%). Two- and 3-vessel disease was present in 73.3% and 26.7% of patients, respectively. Lesions investigated were "intermediate" with median percent stenosis, median FFR, and median iFR at 60% (interquartile range [IQR]: 50% to 70%), 0.84 (IQR: 0.78 to 0.90), and 0.92 (IQR: 0.85 to 0.96), respectively. Vessel management was reclassified by physiology in 30.0% (249 of 828) of vessels. Patient and overall management were reclassified in 26.9% (130 of 484) and 45.7% (211 of 484) of patients, respectively. Reclassification rates were high irrespective of initial management (optimal medical therapy, percutaneous coronary intervention, or coronary artery bypass grafting), and performance and results of pre-procedural noninvasive tests. Reclassification of overall management in particular increased with the number of vessels investigated (1 vessel: 37.3%; 2 vessels: 45.0%; 3 vessels: 66.7%; p = 0.002). Incorporating iFR in the decision process was associated with investigation of more vessels (p = 0.04) and higher reclassification (p = 0.0001). CONCLUSIONS: In patients with MVD and intermediate coronary lesions, invasive physiology at time of angiography reclassifies revascularization strategy in a large proportion of cases (26.9%) and investigation of more vessels is associated with higher reclassification rates.

Interventional radiology treatments for iatrogenic severe bleeding during percutaneous coronary interventions.

PURPOSE: Interventional cardiology and interventional radiology are separate medical disciplines in which intra-arterial contrast media are used. Interventional cardiology has resigned from many types of treatment techniques that are now used and developed in the field of interventional radiology. In the event of iatrogenic bleeding during coronary interventions, there is an urgent need to use safe and efficient rescue procedures that are as efficient as cardiosurgery but use simpler treatment options. Serious perforations require immediate endovascular interventions. Medical history may reveal risk factors for artery perforation. Medicines, location of artery perforation, and extent of bleeding are directly associated with the prognosis. Most often, arterial perforations are due to inappropriate wire manipulation or use of oversized balloons or cutting balloons. Prolonged, artery-occluding balloon inflation, covered stent implantation, and embolisation with different agents are among the available treatment options for artery ruptures. MATERIAL AND METHODS: A retrospective analysis was carried out among selected patients with iatrogenic vascular complications during procedures involving either coronary or non-coronary arteries. RESULTS: Only representative cases were selected and presented in the patient subsection. CONCLUSIONS: Artery perforation during cardiac catheterisation can lead to dire consequences. To manage this complication, clinicians need pre-established procedures, adequate resources, and knowledge. Interventional radiology can be used as a salvage therapy in such cases.

[Bioresorbable scaffolds in the treatment of coronary artery disease. Expert consensus statement of the Association of Cardiovascular Interventions of the Polish Cardiac Society (ACVI PCS)]. / Zastosowanie rusztowan bioresorbowalnych w leczeniu choroby wiencowej. Stanowisko grupy ekspertów Asocjacji Interwencji Sercowo-Naczyniowych Polskiego Towarzystwa Kardiologicznego (AISN PTK).

Bioresorbable scaffold coated with antimitotic drug is the latest development in the coronary stents technology. The concept of temporary scaffolding and natural vessel healing after angioplasty is a very attractive alternative to conventional metal stents. The results of the first observational studies have confirmed their ultimate biodegradation. Newest results of randomised trials and registries in broader clinical and anatomical indications also revealed the limitations of the first generation of scaffolds. The relatively thick polymeric struts and compliance with specific implantation protocol may influence the results. In this document, the group of experts presents the current state of knowledge, with a particular focus on the advantages and limitations of the new technology; it presents practical guidelines for optimal implantation techniques and clarifies documented indications for patients and lesions selection.

Can we improve the accuracy of risk assessment in patients with non ST-segment elevation acute coronary syndromes?

BACKGROUND: In patients with non-ST segment elevation acute coronary syndromes (NSTE-ACS), the long-term risk of deathand myocardial infarction (MI) is estimated by scores based on noninvasively derived variables. Much less is known about the relation between the degree of atherosclerotic burden in the coronary tree and the long-term risk of patients with NSTE-ACS. AIM: To evaluate the accuracy of a wide spectrum of coronary angiographic and clinical data in predicting outcomes ina long-term follow-up of patients successfully treated invasively for NSTE-ACS. METHODS: The study group consisted of 112 consecutive patients (age 62 ± 10 years; 76 men) treated invasively for NSTE-ACS.27 (24%) patients had a history of diabetes mellitus (DM) and 37 (33%) patients a history of MI. The coronary angiograms priorto intervention were evaluated blindly for the four angiographic scores: (1) Stenosis score derived from the assessment of thedegree of stenosis in 15 segments of the coronary tree; (2) Vessel score showing the number of main vessels stenosed > 70%; (3) Extensity score assessing the proportion of lumen length irregularity in 15 segments; and (4) Complexity score describingthe number of complex plaques. The angiographic analysis also focused on the flow, presence of thrombus and collateralsupply prior to intervention (according to TIMI) and the size of the culprit lesion vessel. The intervention was successful in 95% of cases. All patients were followed-up for 6-24 months for the occurrence of death or MI. RESULTS: In the follow-up period, the composite end point of death or MI occurred in 20 (17%) patients. In order to indicate therisk predictors from the group of clinical and angiographic variables (age, sex, history of DM, history of MI, four angiographicscores and culprit lesion vessel characterisation), logistic regression analysis was performed. The independent angiographic predictors of composite end point (selected by forward conditional selection) were stenosis score (OR 1.13; 95% CI 1.05-1.2;p < 0.001) and size of the vessel (OR 0.08; 95% CI 0.01-0.6; p = 0.02). CONCLUSIONS: Our preliminary data shows that attempting to add angiographic variables into the risk assessment scoring systems in order to strengthen their predictive accuracy is justified.

Assessment of the prognostic value of coronary angiography in patients with non-ST segment elevation myocardial infarction.

BACKGROUND: Management of patients with acute non-ST segment elevation myocardial infarction (NSTEMI) depends on risk evaluation. The recommended approach involves the use of risk stratification tools such as TIMI and GRACE risk scores. However, these clinical scores do not include variables derived from coronary angiography which is currently performed in most patients. AIM: To evaluate the prognostic value of adding selected coronary angiographic parameters to the established TIMI and GRACE risk scores. METHODS: We studied consecutive patients with NSTEMI who underwent coronary angiography. We evaluated selected vascular variables (vessel score, lesion location, percent stenosis, presence of thrombus, lesion length, vessel size, TIMI flow, lesion type according to the ACA/AHA classification, and extent score) and estimated risk using the TIMI and GRACE scores. We assessed total mortality at 30 days, 180 days, and 3 years. To determine the prognostic value of vascular variables and risk scores, we used a logit model and the Hosmer-Lemeshow test. Diagnostic utility of the models was measured by the area under receiver operating characteristic (ROC) curves. To determine usefulness of selected vascular variables as outcome predictors in addition to the GRACE and TIMI scores, we used Net Reclassification Improvement (NRI) and Integrated Discrimination Improvement (IDI) indices. RESULTS: The study included 237 patients (mean age 65.5 years, 62% men). The TIMI and GRACE risk scores were good predictors of mortality in the evaluated periods. Among vascular variables, independent prognostic factors included the extent score which predicted mortality at 30 days (odds ratio [OR] 12.7, 95% confidence interval [CI] 1.6-99, p = 0.016), 180 days (OR 8.8, 95% CI 2.3-33.7, p = 0.002), and 3 years (OR 3.5, 95% CI 1.6-8.0, p = 0.003), and distal lesion location which predicted mortality at 180 days (OR 3.1, 95% CI 1.0-9.4). Addition of the extent score to the TIMI risk score improved the prognostic value of the latter at all time points, as confirmed by NRI and IDI indices. The GRACE risk score itself had good prognostic value which was not significantly improved by any of the evaluated vascular variables. CONCLUSIONS: The extent score added to the TIMI risk score improves the prognostic value of the latter in patients with NSTEMI. Angiographic variables should be more widely used in risk stratification models in patients with acute coronary syndromes.

Participation in thrombolytic trials delays reperfusion therapy in acute myocardial infarction.

BACKGROUND: Shortening the time delay at the beginning of treatment in ST-segment elevation myocardial infarction (STEMI) has proven to be clinically essential. Invasive vs. thrombolytic treatment strategy is currently under investigation, particularly in terms of the time from the onset of symptoms to treatment initiation. It is likely that enrolment to trials in STEMI may paradoxically prolong the time delay to treatment if randomisation procedures are too complex. AIM: To evaluate time to the onset of reperfusion therapy (door-to-thrombolysis time - DtT) in patients randomised to trials (TT) or treated routinely with thrombolytics (Thrx). METHODS: We evaluated DtT in a group of 189 consecutive STEMI patients (TT: n = 96; Thrx: n = 93). The inclusion criteria for the analysis were identical in both groups: 1. STEMI diagnosis was given on admission. 2. Patients had no signs of heart failure. 3. Patients did not require any additional therapy prior to thrombolysis (no need for electrical cardioversion or blood pressure lowering). 4. There were no contraindications for immediate reperfusion therapy. The comparison of DtT between evaluated groups was performed. To find out the independent predictors of DtT prolongation, the impact of patients' age, gender, admission time, pre-hospital delay and trial participation has been evaluated in multivariate analysis. RESULTS: Highly statistically longer mean value of DtT was measured in the entire TT group than in Thrx (41 ± 18 vs. 22 ± 8 min; p 〈 0.001). The difference was also significant for patients who constituted the subgroup of TT who were proposed and refused to participate in trials (37 ± 13 vs. 22 ± 8 min; p 〈 0.01). No differences in DtT were found between groups of patients enrolled to various trials. The participation in TT was found to be the strongest predictor of DtT prolongation over 30 min (OR 13.2; 95% CI 6.1-28.5; p 〈 0.001). The risk of over 30 min DtT prolongation was five times higher if patients were admitted in an early phase of the trial. CONCLUSIONS: 1. Participating in trials delays the beginning of reperfusion therapy. 2. This delay may be clinically important, particularly in patients hospitalised in a very early phase of STEMI. 3. The call for reappraisal of informed consent issues and randomisation procedures in the context of simplicity seems to be justified.

The diagnostic and prognostic value of right ventricular myocardial velocities in inferior myocardial infarction treated with primary percutaneous intervention.

BACKGROUND: Right ventricular (RV) involvement increases mortality and morbidity in inferior myocardial infarction (MI). There are sparse data on the usefulness of pulsed tissue Doppler imaging (TDI) in the diagnosis of RV dysfunction in ST segment elevation MI (STEMI) treated by primary percutaneous coronary intervention (pPCI). AIM: To evaluate the diagnostic and prognostic significance of RV myocardial velocities compared to classical electrocardiographic RVMI diagnostic criteria in this group of patients. METHODS: Consecutive patients with first, acute, inferior STEMI treated with pPCI were prospectively assessed. The RVMI was defined as an ST-segment elevation ≥ 0.1 mV in lead V4R. Echocardiography with TDI was performed after pPCI within 24 h of the onset of symptoms. Follow up including in-hospital events was performed. RESULTS: Out of 101 patients (58 males, mean age 63.7 ± 11.1 years), RVMI was found in 37 (37%). In multivariate analysis, peak systolic RV velocity (SmRV) (OR 5.12), peak early diastolic RV velocity (EmRV) (OR 5.03) and RV wall motion abnormalities (OR 4.94) were independent parameters for RVMI diagnosis. Receiver operating characteristics revealed high diagnostic significance of SmRV (C statistics = 0.90) and EmRV (C statistics = 0.89). The SmRV < 12 cm/s as a cut-off for a diagnosis of RVMI had a 89% sensitivity and a 83% specificity, whereas EmRV < 10 cm/s - 81% and 80%, respectively. Multivariate analysis showed that two variables - SmRV and ST-segment elevation ≥ 0.1 mV in lead V4R, were independent predictors of in-hospital prognosis. CONCLUSIONS: Right ventricular myocardial velocities derived from TDI predict ECG diagnosis of RVMI with relatively high sensitivity and specificity. Their high negative predictive value may be of practical importance when ECG tracings are equivocal. More importantly, decreased RV systolic myocardial Doppler velocity predicts unfavourable clinical outcomes in patients with inferior STEMI independently of ECG changes.

Efficacy and safety of closing postcatheterisation pseudoaneurysms with ultrasound-guided thrombin injections using two approaches: bolus versus slow injection. A prospective randomised trial.

BACKGROUND: Thrombin injection is a widely accepted treatment of an iatrogenic arterial pseudoaneurysm. However, the optimal mode of injection and type of pseudoaneurysm amenable to this therapy have yet been established. AIM: To compare efficacy and safety of two approaches to ultrasound-guided thrombin injections into a femoral artery pseudoaneurysm with or without long neck that developed as an iatrogenic complication of cardiac catheterisation. METHODS: Patients were randomised to thrombin administration in a bolus or slow injection. The length and width of aneurysm neck and blood flow velocity in the neck were measured with color Doppler ultrasonography before the closure procedure. Thrombin dose, time to thrombotic occlusion, blood oxygen saturation in a toe of the extremity with the pseudoaneurysm (a marker of silent microembolisation), and clinical signs of distal embolisation were recorded. Between 2006 and 2009, 73 consecutive patients (33 males; mean age 67.8 ± 11.9 years) with femoral pseudoaneurysms complicating cardiac catheterisation were randomised into two groups that were treated with thrombin bolus (n = 40) or slow injection (n = 33). RESULTS: The efficacy of aneurysm closure with either method was similarly high (100% vs 96.8%, NS, respectively) and did not depend on the length and width of the aneurysm neck. Independent risk factors for distal embolisation were: thrombin dose (OR 4.2; 95% CI 0.92-19.3), the length of aneurysm neck (OR 4.66; 95% CI 1.1-19.9), age above 80 years (OR 10.9; 95% CI 1.0-116.8), and bolus treatment (OR 7.6; 95% CI 1.3-44.9). We observed silent microembolisation phenomenon that was common (occurring in 38% of patients in the bolus group vs 33% of patients in the slow injection group) but in most cases asymptomatic. CONCLUSIONS: Femoral pseudoaneurysm closure with a low dose of thrombin is a valid and beneficial treatment. Either method (bolus or slow injection) was similarly efficacious and safe even in the subgroup of patients with neckless aneurysms. We observed and confirmed silent microembolisation phenomenon during thrombin injections.

Impact of diabetes on survival in patients with ST-segment elevation myocardial infarction treated by primary angioplasty: insights from the POLISH STEMI registry.

BACKGROUND: It has been shown that, among patients with ST-segment elevation myocardial infarction (STEMI), diabetes is associated with a significantly higher mortality. The aim of this study was to investigate in a large cohort of patients the impact of diabetes on mortality in a large cohort of patients with STEMI treated with primary angioplasty. METHODS: Our population is represented by consecutive patients with STEMI treated by primary angioplasty and enrolled in the POLISH registry in 2003. All clinical, angiographic, and follow-up data were prospectively collected. Diagnosis of diabetes was based on history of diabetes at admission. RESULTS: Among 7193 patients, 877 (12.2%) had diabetes at admission. Diabetes was associated with more advanced age (p<0.0001), higher prevalence of female gender (p<0.0001), hyperlipidemia (p<0.0001), shock at presentation (p<0.0001), renal failure (p<0.0001), previous myocardial infarction (p<0.0001), more often treated after 6h from symptom onset (p<0.0001). Diabetes was associated with more extensive coronary artery disease (p<0.0001), less often treated with stenting (p<0.0001). Diabetes was significantly associated with impaired epicardial reperfusion (TIMI 0-2: OR [95% CI]=1.81 [1.5-2.18], p<0.0001), that persisted after correction for baseline confounding factors (OR [95% CI]=1.33 [1.075-1.64], p=0.009). At a mean follow-up of 524+/-194 days, diabetes was associated with higher mortality (unadjusted cumulative mortality: 23.5% vs. 12.6%, unadjusted HR=1.95 [1.66-2.3], p<0.0001), that persisted after correction for confounding factors (adjusted cumulative mortality: 13.3% vs. 10.7%, adjusted HR=1.23 [1.04-1.46], p=0.013). CONCLUSIONS: This study shows that among STEMI treated by primary angioplasty diabetes is independently associated with impaired epicardial reperfusion and higher mortality.

Influence of different antiplatelet treatment regimens for primary percutaneous coronary intervention on all-cause mortality.

AIMS: The aim of this analysis was to examine the influence of different in-cath-lab antiplatelet regimens for the primary percutaneous coronary intervention (PCI) on all-cause mortality. METHODS AND RESULTS: The study group consisted of 7193 patients (pts) undergoing primary PCI in 38 centres in 2003 in Poland. All patients received pretreatment with 300 mg of aspirin, 992 pts (14%) received glycoprotein (GP) IIb/IIIa inhibitors, 2690 pts (37%) were treated with 300 mg loading dose of clopidogrel, and 1566 (22%) received combined antiplatelet treatment with both GP IIb/IIIa inhibitors and clopidogrel. Remaining 1945 patients (27%) did not receive GP IIb/IIIa inhibitors or clopidogrel. Primary endpoint of the study was all-cause mortality up to 1 year from ST-segment elevation myocardial infarction (STEMI). One year mortality rates in the four groups were: 10.4%, 9.0%, 9.7%, and 15.3%, respectively. Propensity-adjusted survival analysis showed significant reduction of mortality for combination therapy with GP IIb/IIIa inhibitors and clopidogrel, clopidogrel alone, and GP IIb/IIIa inhibitors alone over aspirin alone. No additive effect on survival was seen for a combination therapy with GP IIb/IIIa inhibitors and clopidogrel in comparison to treatment with clopidogrel alone. CONCLUSION: In this large cohort, multicentre STEMI registry in-cath-lab use of GP IIb/IIIa inhibitors and clopidogrel alone or in combination was associated with the reduction of 1 year all-cause mortality in the setting of primary PCI in comparison with aspirin only. However, the use of GP IIb/IIIa inhibitors on top of 300 mg loading dose of clopidogrel did not further reduce mortality.