Performance of the minimalistic hybrid approach algorithm versus other conventional algorithms in the percutaneous treatment of chronic total occlusions.

BACKGROUND: The "Minimalistic Hybrid Approach" (MHA) has been proposed to reduce the invasiveness of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). AIMS: This study aims to assess whether MHA may also reduce the utilization of PCI resources (devices, radiations, and contrast) by comparing it with other conventional algorithms. METHODS: We aimed to assess the impact of MHA on device, radiation, and contrast usage during CTO-PCI analyzing data from the Belgian Working Group on CTO (BWG-CTO) registry. Patients were divided, depending on the algorithm used, into two groups: Conventional versus Minimalistic. Primary objectives were procedure performance measures such as device usage (microcatheters and guidewires), radiological parameters, and contrast use. At 1-year follow-up, patients were evaluated for target vessel failure (TVF), defined as a composite of cardiac death, new myocardial infarction, and target vessel revascularization. RESULTS: Overall, we analyzed 821 CTO-PCIs (Conventional n = 650, Minimalistic n = 171). The Minimalistic group demonstrated higher complexity of CTO lesions. After adjusting for propensity score, the Minimalistic group had a significantly lower number of microcatheters used (1.49 ± 0.85 vs. 1.24 ± 0.64, p = 0.026), while the number of guidewires was comparable (4.80 ± 3.29 vs. 4.35 ± 2.94, p = 0.30). Both groups had similar rates of success and procedural complications, as well as comparable procedural and fluoroscopic times and contrast volume used. At the 1-year follow-up, both groups showed comparable rates of TVF (hazard ratio: 0.57; 95% confidence interval: 0.24-1.34, p = 0.195). CONCLUSION: The MHA may slightly reduce the number of dedicated devices used during CTO-PCI, without adversely affecting the procedural success or long-term outcome.

Heart Failure-Related Outcomes in Patients with Left Ventricular Dysfunction Undergoing Percutaneous Chronic Total Occlusion Revascularization.

Background: The presence of a chronic total occlusion (CTO) and severe left ventricular (LV) systolic dysfunction are known negative prognostic factors in patients with coronary artery disease. Several studies have examined the effect of CTO revascularization on mortality, symptoms, occurrence of myocardial infarction (MI), and cardiac function in patients with normal or reduced LV function. However, the effect of CTO revascularization on heart failure-related events in patients with LV dysfunction, such as heart failure hospitalization (HFH), the occurrence of atrial fibrillation (AF), and a worsening renal function (WRF), has not yet been evaluated. To assess the success rate and safety of CTO percutaneous coronary interventions (PCIs) in coronary patients with LV ejection fractions of ≤ 40% and evaluate the impact of successful CTO revascularization on HFH, occurrence of AF, and WRF. Methods: Prospectively, data were collected from CTO PCIs performed at three referral centers and analyzed. From a total of 1435 CTO PCIs, 132 (9.2%) patients with a left ventricular ejection fraction (LVEF) of ≤ 40% were included in this analysis. The median follow-up duration was 23.18 months (interquartile range (IQR): 11.02-46.66 months). Results: A successful CTO PCI was achieved in 109 of these patients, while the procedure was unsuccessful in 23 patients (82.5% procedural success rate). Overall, the intervention had an acceptable number of peri-procedural (or in-hospital) complications (9.1%). During the follow-up period, the rates of all-cause death, cardiovascular death, and non-fatal MI were not significantly different between the two groups. The rates of HFH were significantly lower in the successful PCI group, while WRF and AF did not differ between successful and unsuccessful PCI groups. Successful PCI and higher estimated glomerular filtration rate (eGFR) were independent predictors of a lower risk of HFH, while prior stroke and diabetes were independent predictors of a higher risk of HFH. Conclusions: In patients with reduced LV systolic function (ejection fraction, EF ≤ 40%), CTO PCI is a safe and effective procedure and successful CTO PCI is independently associated with a lower risk of HFH during follow-up. Further expansion of this cohort is necessary to confirm these results.

Comparison of Radifocus versus Silverway Guidewires for Percutaneous Radial Angiography Following Failed Use of a J-Tip Guidewire.

BACKGROUND During transradial coronary angiography, when conventional J-tip wires fail to deliver catheters to the aortic root due to anatomical obstacles, additional hydrophilic wires, such as Radifocus (Terumo) or Silverway (Asahi), are used. We recently showed that the Silverway guidewire was effective at delivering the catheter to the aortic root. In this study, we aimed to compare the efficacy and safety of Radifocus and Silverway guidewires in 100 patients after failed use of the J-tip guidewire. MATERIAL AND METHODS After patients had a failure of a conventional J-tip wire to reach the aortic root, 100 patients were 1:1 randomized to either the Silverway or Radifocus wire. All patients with failure of the J-tip wire were eligible. The primary endpoint was the time between wire entry in the catheter and successful delivery of the catheter to the aortic root. Secondary endpoints included change of access site, number of complications, and questionnaires on subjective wire assessments by the performing interventional cardiologist. RESULTS The primary endpoint was significantly shorter in patients randomized to the Silverway arm (median 30 s [21-39] vs 48 s [36-66]; P<0.001)). The percentage of patients with change of access site was not different between the groups (2 vs 2, not significant). Only 1 minor complication (2%) occurred, in the Radifocus group. Questionnaires revealed that torque control, crossing, and support were all significantly better with the Silverway wire (P<0.001). CONCLUSIONS Silverway showed superior torque control, resulting in faster catheter delivery to the aortic root when compared with the Radifocus guidewire.

Management of stent underexpansion using intravascular lithotripsy-Defining the utility of a novel device.

OBJECTIVES: This study aimed to present a case series of patient treated for stent underexpansion resistant to conventional treatment with intravascular lithotripsy (IVL). BACKGROUND: Stent underexpansion is a powerful predictor of long-term stent patency and correlates with unfavorable clinical outcomes. This case series demonstrates the utility of IVL in managing stent underexpansion resistant to conventional treatment. METHODS: We describe a case series of patients with stent underexpansion due to calcific coronary artery disease treated with IVL. Stent underexpansion was identified as an inability to adequately expand stents with conventional treatment. Only cases that failed to achieve adequate expansion with high-pressure noncompliant balloon inflation were included. RESULTS: Thirteen patients from six institutions have been included in this case series. The average age was 70.25 years with 76.9% of male patients. The average pre-IVL minimal stent area (MSA) was 2.71 mm2 , which improved to 6.44 mm2 post-IVL treatment, representing an average MSA gain of 238%. There were no procedural, peri-procedural, or 30-day major adverse cardiac and cerebrovascular event. CONCLUSION: This case series demonstrates that IVL is a feasible, safe alternative for the management of stent underexpansion due to calcific coronary disease.

FFR pressure wire comparative study: piezoresistive versus optical sensor.

BACKGROUND: This study aimed to assess the reliability of pressure derived fractional flow reserve (FFR) measurement and the handling performance of the OptoWire Deux with an optical pressure sensor relative to both the PressureWire X and the Verrata Pressure wire with piezoresistive pressure sensors. METHODS: This single centre study included 80 patients between October 2016 and May 2017 undergoing a diagnostic coronary angiography. The reliability of FFR measurement measured with the OptoWire Deux relative to the PressureWire X and Verrata Pressure wire was assessed by the presence of drift. Drift was defined as a Pd/Pa measurement different from 1.00 ± 0.02 when pulled back after a FFR measurement at the location of the initial equalisation. Handling characteristics for all pressure wires were assessed qualitatively with respect to the PressureWire Aeris. RESULTS: Ninety-eight measurements in 78 patients were performed; two patients were excluded because the lesion could not be crossed. Very stable and reliable FFR measurements with the optical sensors were registered, relative to the piezoresistive pressure sensors. Drift was found in 11%, 37%, and 33% of the measurements for OptoWire Deux, PressureWire X, and Verrata Pressure wire respectively. The handling performance of the OptoWire Deux was better rated for steerability and torqueability in relation to the standard FFR wire. The handling of the PressureWire X was rated equally good whereas the handling of the Verrata pressure wire was rated inferior in relation to the standard FFR wire. CONCLUSIONS: In patients undergoing FFR measurement, the OptoWire Deux has a stable and reliable pressure hence FFR measurement with fewer drift events and has good handling characteristics.

FFR pressure wire comparative study for drift: piezo resistive versus optical sensor.

BACKGROUND: This study aimed to assess the stability of pressure derived fractional flow reserve (FFR) measurement and the handling performance of the OptoWire Deux with an optical pressure sensor relative to the PressureWire X with piezo resistive pressure sensors. METHODS: This multicenter centre observational study included 50 patients between June 2017 and November 2018 undergoing a diagnostic coronary angiography with FFR measurement of moderate to severe lesions. The reliability of FFR measurement measured with the OptoWire Deux relative to the PressureWire X in each lesion was assessed by the presence of drift. Handling characteristics for both pressure wires were assessed by a 5-point scale and by comparing the time between equalization and crossing the distal target lesion. RESULTS: Hundred and sixteen measurements in 50 patients were performed. Very stable and reliable FFR measurements with the optical sensors were registered, relative to the piezo resistive pressure sensors. There is statistically significant difference in favor of the OptoWire Deux over the PressureWire X (P=0.001). However, the differences are small, when drift values were compared as continuous variables, no statistically significant difference was found for both directional (P=0.435) as for absolute drift (P=0.058). CONCLUSIONS: In patients undergoing FFR measurement, both optical sensor pressure wires (Optowire Deux) as piezo resistive sensor pressure wires (PressureWire X) generate stable and reliable pressure and thus FFR measurement. The optical pressure sensor is less susceptible for drift relative to the piezo resistive pressure sensor, but the difference is within an acceptable range.

Postdischarge prognostic significance of periprocedural myocardial injury after percutaneous intervention of chronic total occlusion.

BACKGROUND: The postdischarge prognostic implication of periprocedural myocardial injury in patients undergoing percutaneous coronary intervention (PCI) of a chronic total occlusion (CTO) remains scarcely studied. AIMS: The aim of this study is to assess the prognostic value of periprocedural myocardial injury, defined by increased high-sensitive troponin T (hs-TnT) levels according to updated guidelines, after CTO PCI. METHODS: Between September 2011 and April 2020, 726 patients undergoing CTO PCI at 2 Belgian referral centres were prospectively included and divided into 4 groups based on postprocedural hs-TnT levels (unelevated; ≥5 times the upper limit of normal (ULN); ≥35 times the ULN; ≥70 times the ULN). Postprocedural hs-TnT levels were subsequently related to patient and procedural characteristics, 1-year major adverse cardiac and cerebrovascular events (MACCE; excluding in-hospital MACCE) as well as 1-year mortality. RESULTS: At 1 year follow-up (FU), elevated hs-TnT≥5 times and ≥35 times the ULN were associated with higher MACCE rates (p=0.001; p=0.007, respectively). In addition, they also resulted in a higher 1-year mortality rate (p=0.009;p=0.021, respectively). Patients with increased hs-TnT≥5 times the ULN (35% of patients) more frequently had signs of more advanced atherosclerotic disease (previous CABG p<0.001; stroke p≤0.001 and peripheral vascular disease p<0.001) and had higher procedural complexity (Japanese CTO Score p=<0.001, stent length>48 mm p<0.001, procedure time p<0.001). Antegrade wire escalation did not result in lower event rate of postdischarge MACCE compared with the other CTO crossing techniques combined (p=0.158). CONCLUSION: Periprocedural myocardial injury was associated with a significantly higher rate of MACCE and all-cause mortality after 12 months of FU.

Influence of percutaneous transcatheter closure of an atrial septal defect on the atrioventricular conduction.

OBJECTIVE: This study aimed at determining the effect of percutaneous ASD closure on the AV conduction. Percutaneous closure of ostium secundum atrial septal defects (ASDs) has been widely accepted and has become the standard treatment of this malformation. However, some complications have been reported. Because of the close proximity between the discs of the device and the atrioventricular (AV) node, atrioventricular conduction disturbances (AVCD) are a likely complication. METHODS AND RESULTS: From the database of congenital heart disease, 46 patients (mean age 54 +/- 12 y) who underwent percutaneous ASD closure and 46 patients who underwent a percutaneous patent foramen ovale (PFO) closure were matched according to age, gender and follow-up time. Demographic, clinical, biochemical, and ECG variables were compared. Before closure, the PR interval in the ASD group was significantly longer than in the PFO group (169 +/- 22 ms versus 158 +/- 25 ms, P= 0.031), which persisted after a mean follow-up time of 4.5 years (180 +/- 39 ms versus 163 +/- 23 ms, P= 0.007). PR interval increased significantly from closure to latest follow-up in the ASD (P=0.038), but not in the PFO group (P=0.058). CONCLUSIONS: ASD patients presented with significantly longer PR interval than PFO patients before closure. In contrast with the PFO group, the PR interval increased in the ASD group after medium-term follow-up. These findings indicate the need for further follow-up after ASD repair in order to detect potential late AVCD.

Left ventricular function recovery after ST-elevation myocardial infarction: correlates and outcomes.

BACKGROUND: Contemporary data on left ventricular function (LVF) recovery in patients with left ventricular dysfunction after ST-elevation myocardial infarction (STEMI) are scarce and to date, no comparison has been made with patients with a baseline normal LVF. This study examined predictors of LVF recovery and its relation to outcomes in STEMI. METHODS: Patients presenting with STEMI between January 2010 and December 2016 were categorized in three groups after 3 months according to left ventricular ejection fraction (EF): (i) baseline normal LVF (EF ≥ 50% at baseline); (ii) recovered LVF (EF < 50% at baseline and ≥ 50% after 3 months); and (iii) reduced LVF (EF < 50% at baseline and after 3 months). Heart failure hospitalization, all-cause mortality and cardiovascular mortality were compared between the three groups. RESULTS: Of 577 patients, 341 (59%) patients had a baseline normal LVF, 112 (19%) had a recovered LVF and 124 (22%) had a reduced LVF. Independent correlates of LVF recovery were higher baseline EF, lower peak troponin and cardiac arrest. After median 5.8 years, there was no difference in outcomes between patients with LVF recovery and baseline normal LVF. In contrast, even after multivariate adjustment, patients with persistently reduced LVF had a higher risk for heart failure hospitalization (HR 5.00; 95% CI 2.17-11.46) and all-cause mortality (HR 1.87; 95% CI 1.11-3.16). CONCLUSION: In contemporary treated STEMI patients, prognosis is significantly worse in those with a persistently reduced LVF after 3 months, compared with patients with a baseline normal LVF and those with LVF recovery.

Prognostic value of the high-sensitivity troponin T assay after percutaneous intervention of chronic total occlusions.

AIMS: The prognostic value of postprocedural high-sensitivity troponin T (hs-TnT) after percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) is currently unclear. We aimed to assess the prognostic value of elevated hs-TnT after elective CTO-PCI. METHODS: The current study included 409 patients undergoing elective CTO-PCI between September 2011 and August 2016 at two centres who had postprocedural hs-TnT measurements available. Clinical, angiographic and procedural characteristics were correlated with any or at least five times the 99th percentile hs-TnT elevation, as well as a 1-year combined endpoint of major adverse cardiac and cerebrovascular events (MACCE) and mortality. RESULTS: Post-CTO-PCI hs-TnT elevation was observed in 85% (n = 349/409) and at least five times hs-TnT elevation occurred in 42% (n = 172/409) of cases. hs-TnT elevation was more frequent in more complex patients (postcoronary artery bypass grafting, peripheral vascular disease, chronic kidney disease, heart failure and multivessel disease) as well as in the more complex CTO procedures (higher Japanese CTO complexity, use of retrograde and antegrade dissection re-entry techniques). After 1 year of follow-up (FU), MACCE was not associated with postprocedural hs-TnT elevation, both any elevation (10.9 vs. 11.7%; P = 0.846) and at least five times hs-TnT elevation (15.7 vs. 11.7%; P = 0.451; hazard ratio = 1.375, confidence interval: 0.599-3.157, P = 0.453), compared with no elevation. A nonsignificant trend towards higher mortality in the at least five times hs-TnT vs. no elevation group (4.7 vs. 0%; P = 0.091) was observed. CONCLUSION: In patients undergoing CTO-PCI, postprocedural hs-TnT elevation is frequent, but is not correlated with higher MACCE and mortality rates after 1-year FU in our small study population, suggestive of the limited long-term impact of troponin elevation.

Outcomes of the amphilimus-eluting polymer-free stent for chronic total occlusion treatment: a multicentre experience.

AIMS: Late stent thrombosis and delayed vessel wall healing remain an important issue in coronary vessels treated with drug-eluting stents (DES), especially when long-vessel segments need to be covered, like in chronic total occlusions (CTO). Avoiding polymer use to avoid chronic inflammatory responses is a potential solution to reduce target vessel failure (TVF). We aimed to validate the clinical safety and efficacy at 1 year of the polymer-free Cre8 DES vs. nonpolymer-free DES for the percutaneous treatment of CTO. METHODS: Between September 2011 and August 2016, patients were prospectively enrolled in three CTO centres. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), including cardiac death, any myocardial infarction, stent thrombosis, TVF and target vessel revascularization. RESULTS: A total of 102 Cre8 and 133 non-Cre8 patients were enrolled. At 1 year, a low cumulative MACCE was observed in the Cre8 group (6.9%, respectively). Moreover, a numerical trend towards better MACCE was observed in the Cre8 group vs. the non-Cre8 group (6.9 vs. 14.3%; P = 0.065). The clinically driven TVF rate was not statistically different between Cre8 and non-Cre8 patients (6.9 vs. 9.8%; P = 0.373). A borderline significant difference regarding mortality was observed in favour of Cre8 patients (0 vs. 3.8%; P = 0.049). CONCLUSION: Low rates of MACCE and TVF up to 1 year were observed in the Cre8 group, supportive of the use of polymer-free DES for lesions with high complexity.