Treatment of coronary artery disease with a new-generation drug-coated balloon: final results of the Italian Elutax SV rEgistry-DCB-RISE.

AIMS: Drug-coated balloons (DCBs) are a recognized alternative to stents for the treatment of in-stent restenosis (ISR), and there is some initial clinical evidence about their efficacy for the treatment of small coronary vessels. Newer-generation DCBs were developed to overcome the reduced deliverability of the previous generation, also warranting a more effective drug delivery to vessel wall. However, the vast majority of new-generation DCBs still lack of reliability due to paucity of clinical data. METHODS: Between 2012 and 2015, all patients treated with Elutax SV DCB (Aachen Resonance, Germany) at nine Italian centers were enrolled in this retrospective registry. Primary outcome was the occurrence of target-lesion revascularization (TLR) at the longest available follow-up. Secondary endpoints were procedural success and occurrence of device-oriented adverse cardiovascular events including cardiac death, target-vessel myocardial infarction, stroke, and TLR. A minimum 6-month clinical follow-up was required. RESULTS: We enrolled 544 consecutive patients treated at 583 sites. Fifty-three per cent of the patients had ISR, and the rest native vessel coronary artery disease. Procedural success occurred in 97.5%. At the longest available clinical follow-up (average 13.3 ±â€Š7.4 months), 5.9% of the patients suffered a TLR and 7.1% a device-oriented adverse cardiovascular event. We did not register cases of target-vessel abrupt occlusion. At multivariate analysis, severe calcification at the lesion site was the first determinant for the occurrence of TLR. CONCLUSION: This registry on the performance of a new-generation DCB shows an adequate profile of safety and efficacy at mid-term clinical follow-up.

Clinical outcomes with reservoir-based polymer-free amphilimus-eluting stents in real-world patients according to diabetes mellitus and complexity: The INVESTIG8 registry.

BACKGROUND: Patients with diabetes mellitus (DM) remain at higher risk of restenosis after percutaneous coronary intervention despite the use of contemporary drug-eluting stents. The Cre8 amphilimus-eluting stent (AES) has shown promising results in DM patients. Whether this holds true irrespective of patient's clinical and angiographic complexity is unknown. METHODS: Five hundred and ninety five consecutive patients (738 lesions) undergoing AES implantation were included in the INVESTIG8 multicenter registry. Patients were stratified according to DM status and further stratified according to patients' complexity. The prespecified primary endpoint was target lesion failure (TLF)-defined as the composite of cardiac death, target-vessel myocardial infarction, and target lesion revascularization (TLR). RESULTS: DM patients were more often complex as compared to non-DM patients (70% vs. 61%, P = 0.015). At 18-month follow-up, there was a trend to a higher TLF rate in DM than in non-DM patients (6.9% vs. 3.5%, P = 0.063). This was largely driven by a markedly higher risk of TLF among complex DM patients as compared to simple DM patients (8.9% vs. 2.4%, P = 0.053). A multivariate analysis identified complexity (HR 6.11, 95% CI: 1.42-26.2) but not DM (HR 1.59; 95% CI 0.71-3.56) as an independent predictor of TLF. Of note, TLR rates were similar between DM and non-DM patients (3.3% vs. 1.9%, P = 0.228). CONCLUSIONS: In this real-world, multicenter registry the Cre8 AES showed favorable clinical outcomes in DM patients. Increased risk of TLF appears to be driven by patients' complexity rather than DM status. These findings will need to be confirmed in a large-scale randomized trial.

Real-time assessment of myocardial viability in the catheterization laboratory using the intracoronary electrograms recorded by the PTCA guidewire in patients with left ventricular dysfunction: comparison with delayed-enhancement magnetic resonance imaging.

OBJECTIVES: This study aimed to determine whether the intracoronary electrograms (IC-EGMs) recorded using a standard percutaneous coronary intervention guidewire could provide myocardial viability information. BACKGROUND: The revascularization of dysfunctional but viable myocardium may confer prognostic benefits compared with medical therapy in patients with post-ischemic heart failure. However, knowledge of myocardial viability is often unavailable at the time of the procedure. METHODS: The peak-to-peak voltage of 317 IC-EGMs recordings from 25 patients with a previous myocardial infarction and systolic dysfunction were matched with corresponding delayed-enhancement magnetic resonance imaging sites using a 17-segment model of the left ventricle. RESULTS: Sixty-seven recordings were obtained from segments classified as complete scar on delayed-enhancement magnetic resonance imaging (group A), 162 from partially viable segments (group B), and 88 from fully viable segments (group C). Three high-pass (HP) filters (0.5, 30, and 100 Hz) were applied to the signals to modulate their spatial resolution. For all filters, the peak-to-peak voltage significantly decreased from group C to group B to group A (p < 0.001 for all comparisons). When receiver-operating characteristic analysis was used to compare nonviable (group A) with viable (group B + C) segments, the optimal discriminating voltages were 4.6, 2.2, and 0.78 mV for, respectively, HP-0.5, HP-30, and HP-100 filters, with a sensitivity of 92%, 94%, and 99% and a specificity of 70%, 79%, and 69%. CONCLUSIONS: The amplitude of the IC-EGMs discriminates viable from nonviable left ventricular segments. Because this technique is simple and inexpensive and provides real-time results, it is potentially useful to aid decision making in the catheterization laboratory.

Differences in cardiovascular risk factors and clinical outcomes between Western European and Southeast Asian patients treated with the Genous Bio-engineered R stent: an e-HEALING worldwide registry substudy.

OBJECTIVE: Percutaneous coronary interventions (PCIs) are increasingly being performed worldwide to treat patients with coronary artery disease. However, studies on the influence of ethnicity on clinical outcomes after PCI are scarce. In our current analysis, we evaluate the differences in baseline clinical, angiographic and procedural characteristics, and 12-month clinical outcomes in patients undergoing nonurgent PCI in Western Europe and in Asia. METHODS: We analyzed all patients enrolled in the worldwide e-HEALING (electronic Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) registry living in Western Europe and Asia. All patients were treated with at least one endothelial progenitor cell capturing stent. The main study outcome was target vessel failure at the 12-month follow-up, defined as the composite of cardiac death or myocardial infarction and target vessel revascularization. RESULTS: A total of 3504 patients, 2873 living in Western Europe and 731 living in Asia, were assessed in the current analysis. Almost all of the baseline clinical and angiographic characteristics differed significantly between both populations. Target vessel failure at the 12-month follow-up occurred in 11.4% of the Western Europe patients and in 5.6% of the Asian patients (P<0.01). CONCLUSION: We conclude that differences exist in the baseline, angiographic, and procedural characteristics between Western European and Asian patients undergoing nonurgent PCI. In addition, the 1-year clinical outcomes differ significantly after PCI between Western European and Asian patients. Our results indicate that reports from studies performed worldwide should include both overall and regional subgroup outcomes.

Intracoronary electrocardiogram ST segment shift evaluation during intravenous adenosine infusion: a comparison with fractional flow reserve.

BACKGROUND: By measuring the pressure decline caused by coronary narrowing, fractional flow reserve (FFR) is an index of the physiological significance of a vessel stenosis. Intracoronary electrocardiogram (IC-ECG) recording from an angioplasty guidewire is more sensitive than standard ECG in detecting regional myocardial ischemia. The aim of the study was to assess if unipolar IC-ECG ST segment recording from angioplasty guidewire during maximal pharmacologic vasodilation could be used as an indirect estimation of FFR results. METHODS: Forty-eight clinically stable patients with intermediate stenosis underwent FFR evaluation and IC-ECG recording during intravenous adenosine infusion. RESULTS: FFR values were ≤ 0.80 in 26 (54%) patients and > 0.80 in 22 (46%). After adenosine, standard ECG was abnormal in only nine (19%) patients, while IC-ECG showed a significant ST segment shift (IST) in 24 (50%) patients: ST elevation in 19 patients and depression in five). IST was documented in 21/26 patients with FFR ≤ 0.80 (81%) and in 3/22 with FFR > 0.80 (p < 0.001). Sensitivity of IST for predicting an abnormal FFR value was 81%, specificity 86%, positive and negative predictive accuracies were 88% and 79%, respectively. CONCLUSIONS: Intracoronary ST segment shift evaluation during adenosine infusion may be of value in assessing the functional significance of a borderline stenosis. The presence of IST during adenosine infusion could obviate the need for additional FFR evaluation.

Right ventricular pressure changes during induced ventricular tachycardias predict clinical symptoms of cerebral hypoperfusion: implications for a reduction of unnecessary, painful ICD shocks.

BACKGROUND: ICD shocks occurring in conscious patients (as in the case of well-tolerated arrhythmias, electromagnetic interference, or oversensing) have a deleterious impact on the quality of life. We evaluated if a hemodynamic parameter, calculated from the right ventricular pressure (RVP) or systemic arterial pressure (AP) signals, could predict early clinical symptoms of cerebral hypoperfusion during induced ventricular tachycardias (VTs). METHODS AND RESULTS: We analyzed 42 tolerated (no symptoms) and 30 untolerated (syncope or severe symptoms within 30 seconds from the onset) VTs, induced during electrophysiological study. The cycle length (CL) and the hemodynamic data (mean AP and RVP, arterial pulse pressure and RV pulse pressure, and maximum AP and RVP dP/dT) were automatically sampled in two VT epochs: the "detection" window, from beat 24 to 32, and the "preintervention" window, immediately before the first therapeutic attempt. Although the CL and all the hemodynamic parameters (expressed as % change versus pre-VT values) were significantly lower in untolerated versus tolerated VTs both at detection and preintervention (with the exception of the mean RVP which progressively increased in both groups), ROC analysis demonstrated that only the preintervention RV pulse pressure showed no overlap between groups, providing 100% sensitivity and positive predictive value. CONCLUSIONS: The reduction of the RV pulse pressure is a better predictor of early cerebral symptoms than CL or other hemodynamic indexes during induced VTs. Since long-term RVP monitoring is feasible, this parameter could be incorporated into ICDs decisional path, in the perspective of reducing unnecessary, painful shocks.

Intracoronary ST-segment shift soon after elective percutaneous coronary intervention accurately predicts periprocedural myocardial injury.

BACKGROUND: Elevation of cardiac biomarkers after coronary angioplasty (percutaneous coronary intervention [PCI]) reflects periprocedural myocardial damage and is associated with adverse cardiac events. We assessed whether periprocedural myocardial damage that occurs despite successful PCI could be rapidly and easily identified by intracoronary ST-segment recording with the use of a catheter guidewire. METHODS AND RESULTS: In 108 consecutive stable patients undergoing elective single-vessel PCI, we recorded unipolar ECG from the intracoronary guidewire in the distal coronary before PCI and 2 minutes after the last balloon inflation. After PCI, intracoronary ST-segment shift > or = 1 mm from baseline was considered significant. Troponin I levels were measured at baseline and at 8 and 24 hours after intervention, and myocardial damage was defined as troponin I increase above the upper normal value after intervention. All patients had normal cardiac marker values before PCI, and PCI was successful in all (residual stenosis < 20%, Thrombolysis in Myocardial Infarction grade 3 flow). After PCI, long-term follow-up data were collected; myocardial damage was detected in 50 patients (46%), although abnormal creatine kinase-MB values were documented in only 11 (10%). Significant intracoronary ST-segment shift after PCI was present in 40 patients (37%; group A) and absent in the remaining 68 (63%; group B). Procedural myocardial damage was documented in 37 group A patients (93%) and in 13 group B patients (19%; P<0.001); significant ECG changes were found on standard ECG after intervention in only 5 patients (13%) and 1 patient (1%) (P<0.05). Sensitivity of intracoronary ST-segment shift for predicting myocardial damage was 74%, and specificity was 95%, with positive and negative predictive values of 93% and 81%, respectively. On multivariate analysis, intracoronary ST-segment shift was the sole independent predictor of myocardial damage (odds ratio, 54.1; 95% confidence interval, 12.1 to 240; P<0.0001). At a median follow-up of 12+/-5 months, major coronary event-free survival was significantly worse in group A patients (log-rank test chi2=4.0; P<0.05). CONCLUSIONS: After successful single-vessel PCI, intracoronary ST-segment shift allows the prompt and inexpensive identification of patients developing myocardial injury, who may require adjunctive therapy and longer in-hospital stay.

Intracoronary ST segment evolution during primary coronary stenting predicts infarct zone recovery.

In patients with acute myocardial infarction (AMI), early ST segment elevation resolution on ECG predicts myocardial reperfusion and LV recovery. Intracoronary ECG is more sensitive than surface ECG to detect regional ischemia. In patients undergoing primary percutaneous coronary intervention (PCI), we investigated if failed myocardial reperfusion, despite successful infarct vessel recanalization, could be rapidly and easily identified by intracoronary ST segment monitoring from guidewire recording. We recorded intracoronary and standard ECG during primary coronary stenting (PCI) in 50 patients with AMI (59 +/- 11 years; anterior AMI in 66%). All patients had a successful PCI and underwent 2D echocardiography soon after PCI and 6 months later. Following PCI, intracoronary ST resolution >/= 50% from baseline was documented in 39 patients (78%; group A; from 11 +/- 8 to 1 +/- 2 mm) but not in 11 (22%; group B; from 11 +/- 8 to 8 +/- 5 mm). Group A had slightly shorter ischemic time (202 +/- 94 vs. 238 +/- 112 min in B; P = 0.2) and smaller peak CK values (2,752 +/- 2,038 vs. 4,802 +/- 3,671 U/L in B; P = 0.02). After PCI, ST resolution was found on standard ECG in 34 (87%) group A and in 3 (27%) group B patients. At 6-month follow-up, left ventricular ejection fraction was greater in group A (47% +/- 8% vs. 39% +/- 8% in B; P < 0.001) with improved wall motion score index (from 2.2 +/- 0.3 to 1.7 +/- 0.3 in A; from 2.3 +/- 0.4 to 2.1 +/- 0.4 in B; P < 0.001). There were no significant differences between intracoronary and standard ECG for sensitivity (92% vs. 86%) and specificity (62% vs. 57%) to predict improved infarct zone recovery after 6 months. ST elevation resolution on intracoronary recording during PCI predicts infarct zone recovery. Monitoring ST segment evolution by intracoronary ECG allows prompt and inexpensive identification in the catheterization laboratory of those patients without myocardial reperfusion, who may require adjunctive therapeutic interventions after successful infarct vessel recanalization.