Location of side branch access critically affects results in bifurcation stenting: Insights from bench modeling and computational flow simulation

Background

The aim of this study was to evaluate the impact of stent design and side branch access on final strut apposition during bifurcation stenting.

Methods and results

A series of 6 different commercially available Drug Eluting Stents (DES) (n = 42) were deployed in an identical model of a coronary bifurcation. Kissing Balloon (KB) optimization was performed after either proximal or distal recrossing of the guidewire and results were analyzed by micro-Computed-Tomography.Stent design only had a minor impact on side branch lumen area free of stent struts. Similar rate of strut malapposition was observed within the bifurcation when a consistent KB optimization protocol and an optimal distal recrossing of the wire to reaccess the side branch (SB) are followed.Conversely, proximal instead of distal cell recrossing toward the side branch produced a significant lower area of the side branch lumen free of struts than an optimal distal recrossing (60.3 ± 7.1% versus 81.1 ± 8.0%, p < 0.0001), as well as a higher rate of strut malapposed toward the SB ostium (40.6 ± 6.0% versus 26.0 ± 5.7%, p = 0.0005).

Conclusions

Optimal cell recrossing of the guidewire may be critical to ensure successful stent optimization in bifurcation PCI.     

Dedicated two-stent technique in complex bifurcation percutaneous coronary intervention with use of everolimus-eluting stents: The EES-bifurcation study

Objectives

To compare the outcomes of initial one-stent (1S) versus dedicated two-stent (2S) strategies in complex bifurcation percutaneous coronary intervention (PCI) using everolimus-eluting stents (EES).

Background

PCI of true bifurcation lesions is technically challenging and historically associated with reduced procedural success and increased restenosis. Prior studies comparing initial one-stent (1S) versus dedicated two-stent (2S) strategies using first-generation drug-eluting stents have shown no reduction in ischemic events and more complications with a 2S strategy.

Methods

We performed a retrospective study of 319 consecutive patients undergoing PCI at a single referral center with EES for true bifurcation lesions, defined by involvement of both the main vessel (MV) and side branch (SB). Baseline, procedural characteristics, quantitative coronary angiography and clinical outcomes in-hospital and at one year were compared for patients undergoing 1S (n = 175) and 2S (n = 144) strategies.

Results

Baseline characteristics were well-matched. 2S strategy was associated with greater SB acute gain (0.65 ± 0.41 mm vs. 1.11 ± 0.47 mm, p < 0.0001). In-hospital serious adverse events were similar (9% with 2S vs. 8% with 1S, p = 0.58). At one year, patients treated by 2S strategy had non-significantly lower rates of target vessel revascularization (5.8% vs. 7.4%, p = 0.31), myocardial infarction (7.8% vs. 12.2%, p = 0.31) and major adverse cardiovascular events (16.6% vs. 21.8%, p = 0.21).

Conclusion

In this study of patients undergoing PCI for true coronary bifurcation lesions using EES, 2S strategy was associated with superior SB angiographic outcomes without excess complications or ischemic events at one year.     

A “Jail Escape Technique” (JET) for distal side branch wiring during provisional stenting: Feasibility and first‐in‐man study

Objective

To evaluate the feasibility of a novel technique for achieving distal SB access and improve strut apposition during provisional stenting.

Background

While distal rewiring and stent expansion toward the side branch (SB) are associated with better results during provisional stenting of coronary artery bifurcation lesions, these techniques are technically challenging and often leave unopposed struts near the carina.

Methods

The “Jail Escape Technique” (JET) is performed by passing the proximal tip of the SB wire between the main vessel (MV) stent struts and balloon before implantation, allowing the MV stent to push the SB wire against the distal part of the carina. The MV stent can then be deployed without jailing the SB wire. Distal SB access and strut distribution at the carina were tested in phantom and swine models. Stent distortion, dislodgement forces, and material damage were evaluated with tensile testing. Human feasibility was then tested on 32 patients.

Results

Preclinical testing demonstrated that the SB wire was located at the most distal part of the carina and no strut malapposition at the carina was present after balloon inflation. Stent distortion, dislodgement forces, or material damage were not affected. JET was successfully performed in 30 of 32 patients. No major adverse cardiovascular events occurred in any patient at 6‐month follow‐up.

Conclusion

The “JET” enables distal SB access and eliminates strut malapposition at the carina. Further studies with larger numbers of patients are needed to further investigate this technique.

     

Ultrasound study of the prevalence of plaque at the carina in lesions that affect the coronary bifurcation. Implications for treatment with provisional stent

Introduction and objectives

The plaque distribution patterns in coronary bifurcation lesions are not well understood. It has been speculated that carina is free of plaque partly because of high wall shear stress providing an atheroprotective effect. To study plaque distribution with intravascular ultrasound (IVUS) in the coronary bifurcation and the prevalence of carina involvement.

Methods

IVUS study was performed on 195 coronary bifurcation lesions in the main vessel (MV) and on 91 in the side branch (SB). Plaque at the carina was considered when its thickness was > 0.3 mm. Plaque burden was measured at different levels: proximal reference, distal, carina and at the point of minimal lumen area (MLA).

Results

The prevalence of plaque at the carina was 32%. Its thickness was 0.8 (0.36) mm, less than that observed at the counter-carina [1.22 (0.54) mm; P < .01]. The prevalence was higher (52%) when the MLA point was distal to the carina. The plaque at the carina was associated with a lower incidence of damage at the SB ostium after stenting the MV (32% vs 54%; P < .04).

Conclusions

The carina is not immune to atherosclerosis, showing plaque at this level in one third of the bifurcations. The incidence of plaque is higher in those bifurcations with the MLA point distal to the carina and seems to be associated with a lower incidence of damage to the SB ostium.Full English text available from: www.revespcardiol.org     

Relation between poststenting peristent plaque components and late stent malapposition after drug-eluting stent implantation: Virtual histology-intravascular ultrasound analysis

Background

Impact of plaque composition on late stent malapposition (LSM) after drug-eluting stent (DES) implantation has not been evaluated.

Methods

We evaluated the relation between plaque components at poststenting peristent area (between external elastic membrane and stent areas) and LSM after DES implantation in 266 patients (314 native lesions; paclitaxel-eluting stent in 205 lesions, sirolimus-eluting stent in 66 lesions, zotarolimus-eluting stent in 32 lesions and everolimus-eluting stent in 11 lesions) in whom virtual-histology intravascular ultrasound was performed at index (poststenting) and follow-up (mean: 11.7 ± 4.8 months).

Results

LSM occurred in 24 patients with 30 lesions (9.6%) and there were no significant differences in the incidences of LSM among 4 DES groups [21/205 (10.2%) in paclitaxel-eluting stent, 6/66 (9.1%) in sirolimus-eluting stent, 2/32 (6.3%) in zotarolimus-eluting stent and 1/11 (9.1%) in everolimus-eluting stent, p = 0.5)]. Patients with LSM were presented with more acute myocardial infarction (50% vs. 28%, p = 0.026) and were more diabetics (50% vs. 30%, p = 0.030) compared with those without LSM. Lesions with LSM had more poststenting peristent %necrotic core (NC) volume compared with those without LSM (25.8 ± 11.1% vs. 21.0 ± 5.7%, p < 0.001). Independent predictors of LSM were poststenting peristent %NC volume [odds ratio (OR); 1.216, 95% CI; 1.053–1.405, p = 0.008], acute myocardial infarction (OR; 2.897, 95% CI; 1.675–4.118, p = 0.029), and diabetes mellitus (OR; 2.413, 95% CI; 1.543–3.996, p = 0.038).

Conclusions

Poststenting peristent NC component especially in patients with acute myocardial infarction and in those with diabetes mellitus is associated with the development of LSM after DES implantation.     

Differential healing response attributed to culprit lesions of patients with acute coronary syndromes and stable coronary artery after implantation of drug-eluting stents: An optical coherence tomography study

Background

Pathology studies have shown delayed arterial healing in culprit lesions of patients with acute coronary syndrome (ACS) compared with stable coronary artery disease (CAD) after placement of drug-eluting stents (DES). It is unknown whether similar differences exist in-vivo during long-term follow-up. Using optical coherence tomography (OCT), we assessed differences in arterial healing between patients with ACS and stable CAD five years after DES implantation.

Methods and results

A total of 88 patients comprised of 53 ACS lesions with 7864 struts and 35 stable lesions with 5298 struts were suitable for final OCT analysis five years after DES implantation. The analytical approach was based on a hierarchical Bayesian random-effects model. OCT endpoints were strut coverage, malapposition, protrusion, evaginations and cluster formation. Uncovered (1.7% vs. 0.7%, adjusted p = 0.041) or protruding struts (0.50% vs. 0.13%, adjusted p = 0.038) were more frequent among ACS compared with stable CAD lesions. A similar trend was observed for malapposed struts (1.33% vs. 0.45%, adj. p = 0.072). Clusters of uncovered or malapposed/protruding struts were present in 34.0% of ACS and 14.1% of stable patients (adj. p = 0.041). Coronary evaginations were more frequent in patients with ST-elevation myocardial infarction compared with stable CAD patients (0.16 vs. 0.13 per cross section, p = 0.027).

Conclusion

Uncovered, malapposed, and protruding stent struts as well as clusters of delayed healing may be more frequent in culprit lesions of ACS compared with stable CAD patients late after DES implantation. Our observational findings suggest a differential healing response attributable to lesion characteristics of patients with ACS compared with stable CAD in-vivo.     

Clinical outcome of patients with de novo coronary bifurcation lesions treated with the Tryton Side Branch Stent. The SAFE-TRY prospective multicenter single arm study

Background

Coronary bifurcation lesions represent a difficult problem regularly confronting interventional cardiologist, in part due to the lack of dedicated device.

Objective

To investigate the feasibility, safety and effectiveness of the Tryton™ Side Branch Stent (Tryton Medical, Durham, NC, USA), a dedicated bare metal stent deployed in conjunction with a standard drug-eluting stent to treat bifurcation lesions.

Methods

The SAFE-TRY is a prospective single arm multicenter registry including patients with de novo bifurcation lesions in native coronary arteries and syntax score < 32. The primary endpoint was target vessel failure (TVF) at 30 days that comprised cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization. Secondary endpoints included device, angiographic and procedural success, 9-month major adverse cardiac and cerebrovascular event (MACCE), and stent thrombosis (ST) rates (ClinicalTrials.gov identifier: NCT01174433).

Results

Among 252 enrolled patients, 24% had diabetes and 35.3% unstable angina. True bifurcation lesions involving both branches occurred in 96.8% of cases with Medina classification 1.1.1 in 62%. The left anterior descending artery and the left main were treated in 70% and 8.3% of the patients, respectively. A 6 Fr guide catheter was used in 61% of the cases. Device, angiographic and procedural success rates were 99.6%, 99.6% and 97.2% respectively. The 30-day TVF was 2.8%; the 9-month MACCE rate was 13.7%, with target lesion revascularization being 4.4%. No definite ST occurred.

Conclusions

This prospective, multicenter study confirmed the feasibility, safety and effectiveness of the Tryton Side Branch Stent to treat patients with de novo complex bifurcation lesions.     

Optical coherence tomography analysis of strut coverage in biolimus- and sirolimus-eluting stents: 3-Month and 12-month serial follow-up

Background

No randomized studies have been conducted to investigate serial changes in optical coherence tomography (OCT) analyses following implantation of biolimus-A9-eluting stents (BES) and sirolimus-eluting stents (SES).

Methods

A total of 60 patients fulfilling the study criteria were randomly assigned into BES (n = 30) and SES (n = 30) implantation groups. Serial OCT evaluation at post-procedure, 3- and 12-month follow-up was performed in 46 patients [BES (n = 22) and SES (n = 24)]. OCT analyses were compared according to the type of stents and the follow-up time intervals. The percentage of uncovered struts was defined as the ratio of uncovered struts to total struts in all cross-sections. The primary endpoint was the percentage change (Δ) of uncovered struts in the 3- and 12-month follow-up samples.

Results

The percentage of uncovered struts at the 3-month time period was not significantly different in the BES and SES groups; the median value (interquartile range) was 14.7% (0.0–23.4) versus 8.6% (0.7–21.5) (p = 0.98), respectively. However, OCT at the 12-month follow-up showed a significantly lower percentage of uncovered struts [2.6% (0.8–5.6) versus 6.2% (1.7–14.7), (p = 0.028), respectively] without significant difference of neointimal thickness. BES showed a greater reduction of percentage Δ of uncovered struts from 3–12 months than that of SES [− 17.2 ± 14.5% versus − 7.7 ± 16.3%, respectively (p = 0.043)].

Conclusions

Both drug-eluting stents showed a high percentage of incomplete strut coverage at 3 months. However, BES showed a significantly lower percentage of uncovered struts at 12 months compared to that of SES. This was achieved by superior strut coverage from 3 to 12 months.     

Bifurcation coronary lesions treated with the "crush" technique: an intravascular ultrasound analysis

OBJECTIVES: We report intravascular ultrasound (IVUS) findings after crush-stenting of bifurcation lesions. BACKGROUND: Preliminary results with the crush-stent technique are encouraging; however, isolated reports suggest that restenosis at the side branch (SB) ostium continues to be a problem. METHODS: Forty patients with bifurcation lesions underwent crush-stenting with the sirolimus-eluting stent. Postintervention IVUS was performed in both branches in 25 lesions and only the main vessel (MV) in 15 lesions; IVUS analysis included five distinct locations: MV proximal stent, crush area, distal stent, SB ostium, and SB distal stent. RESULTS: Overall, the MV minimum stent area was larger than the SB (6.7 +/- 1.7 mm2 vs. 4.4 +/- 1.4 mm2, p < 0.0001, respectively). When only the MV was considered, the minimum stent area was found in the crush area (rather than the proximal or MV distal stent) in 56%. When both the MV and the SB were considered, the minimum stent area was found at the SB ostium in 68%. The MV minimum stent area measured <4 mm2 in 8% of lesions and <5 mm2 in 20%. For the SB, a minimum stent area <4 mm2 was found in 44%, and a minimum stent area <5 mm2 in 76%, typically at the ostium. "Incomplete crushing"--incomplete apposition of SB or MV stent struts against the MV wall proximal to the carina--was seen in >60% of non-left main lesions. CONCLUSIONS: In the majority of bifurcation lesions treated with the crush technique, the smallest minimum stent area appeared at the SB ostium. This may contribute to a higher restenosis rate at this location.     

Neointimal coverage and stent strut apposition six months after implantation of a paclitaxel eluting stent in acute coronary syndromes: An optical coherence tomography study

Objectives

Prospective optical coherence tomography (OCT) study of strut apposition and neointimal hyperplasia thickness (NIH) of a paclitaxel eluting stent (PES), (Infinium, Sahajanand Medical Technologies Pvt Ltd.).

Background

Few data exist concerning neointimal coverage of PES. Uncovered and malapposed struts are more common following stenting in acute coronary syndromes (ACS) than in non-ACS lesions.

Methods

All consecutive patients with ACS, treated with the above PES for single native coronary lesions between August 2008 and January 2009, who consented to invasive follow-up with OCT at six months (N = 13), were included.

Results

At 6 months no patient demonstrated angiographic restenosis. 3180 struts from 20 stents were analyzed, and 91.3% were covered with neointima (NIH 204.8 ± 159.5 μm). Standard statistics and least squares estimates (LSE) derived from a hierarchical ANCOVA model to take into account clustering effects are presented. Rate of uncovered struts was 8.6%, LSE 7.39 (95% CI 3.05-11.73), malapposed struts 2.2%, LSE 1.76 (95% CI 0.05-3.58), and protruding struts 2.9%, LSE 2.8 (95% CI 1.35-4.65). The proportion of uncovered malapposed struts was significantly higher compared to uncovered embedded struts (55.7% vs. 6.8%, p < 0.01). In total, 5 (25%) PES were fully covered by neointima. No intracoronary thrombus or clinical events were detected.

Conclusions

Six months after implantation of a specific PES in patients with ACS, most of the stents were only partially covered with neointima, especially at sites of strut malapposition or protrusion. These findings emphasize the need for optimal stent apposition during implantation and for prolonged dual antiplatelet therapy.     

Feasibility and clinical outcomes of rotational atherectomy for heavily‐calcified side branches of complex coronary bifurcation lesions in the real‐world practice of the drug‐eluting stent era

Objectives

To evaluate the outcomes of rotational atherectomy for heavily‐calcified side branches of coronary bifurcation lesions.

Background

Side‐branch (SB) preservation is clinically important but technically challenging in heavily‐calcified non‐left main true bifurcation lesions. SB rotational atherectomy (SB RA) is sometimes mandatory but the clinical outcomes are not well studied.

Methods

We retrospectively studied the outcomes of patients who underwent RA at our institute for heavily calcified, balloon‐uncrossable or—undilatable SB lesions over an approximately 5‐year period (January 2011 to September 2016).

Results

Two hundred and forty‐four patients underwent main vessel only RA (SB?MV + RA group) and another 48 patients underwent SB RA (SB + MV ± RA group) for 49 side branches. The demographic variables were comparable between the two groups. However, patients underwent SB RA experienced more SB perforations and greater acute contrast‐induced nephropathy (CIN). Among the SB RA patients, 30 (62.5%) underwent RA for both SB and MV (SB + MV + RA subgroup), whereas the other 18 underwent SB only RA (SB + MV?RA subgroup). Patients in these two subgroups could be completed with similar procedural, fluoroscopic durations, and contrast doses. The long‐term MACE rate of SB RA was 27.1% over a mean follow‐up period of 25.1 months with no differences between the two subgroups.

Conclusions

RA for SB preservation in complex and heavily‐calcified bifurcation lesions was feasible with high success rate and quite favorable long‐term outcomes in the drug‐eluting stent (DES) era. Given the higher rates in SB perforation and acute CIN, we recommend that SB RA should be conducted by experienced operators.

     

Rapamycin-eluting stents for the treatment of bifurcated coronary lesions: a randomized comparison of a simple versus complex strategy

Background

Rapamycin-eluting stents (RES) have been shown to reduce restenosis in many types of lesions. However, the ideal strategy for the treatment of coronary bifurcated lesions has not been established to date. This randomized study compares 2 strategies for the RES treatment of bifurcation lesions: a simple approach (stenting the main vessel and balloon dilatation for the side branch [SB]) versus a complex approach (stents for both vessels).

Methods

To compare both strategies, a randomized study was conducted in 91 patients with true coronary bifurcation lestions. All patients received an RES at the main vessel, covering the SB. Patients from group A (n = 47) were assigned to balloon dilation of the involved SB (simple strategy); patients in group B (n = 44) were randomized to receive a second stent at the SB origin (complex strategy). There were no differences between groups regarding baseline clinical and angiographic data.

Results

Major adverse cardiac events occurred in 3 patients from group A (2 non-Q-wave myocardial infarctions and 1 target lesion revascularization). Six-month angiographic reevaluation was obtained in 80 patients (88%). Restenosis of the main vessel was observed in 1 (2%) patient from group A and in 4 (10%) from group B. Restenosis of the SB appeared in 2 (5%) patients from group A and in 6 (15%) from group B.

Conclusions

Both strategies are effective in reducing the restenosis rate, with no differences in terms of clinical outcome. Elective SB stenting seems to provide no advantages over the simpler stent jail followed by SB balloon dilation.     

Clinical outcomes of secondary stent-in-stent self-expanding metal stent placement for primary stent malfunction in malignant gastric outlet obstruction

Background

Although a substantial number of patients require secondary stents insertion due to primary stent malfunction in malignant gastric outlet obstruction, data on the outcomes of secondary self-expanding metal stents are sparse.

Aim

To investigate clinical outcomes and factors related with secondary stent malfunction in patients with malignant gastric outlet obstruction given secondary stent-in-stent self-expanding metal stent insertion.

Methods

For this retrospective study, a total 77 patients who underwent secondary stent-in-stent self-expanding metal stent placement for primary stent malfunction in malignant gastric outlet obstruction were enrolled. We compared the effectiveness and complications of secondary covered and uncovered stents and explored the predictive factors for stent malfunction.

Results

Stent-in-stent self-expanding metal stent placements were technically successful in all patients. Both groups also had comparable clinical success rates (covered stent, 87.2% and uncovered stent, 90.0%, P = 1.000). Stent malfunction rates (31.9% and 36.7% respectively, P = 0.805) and median patency time of stent (165 [95% confidence interval: 112–218] and 165 [95% confidence interval: 126–204] days, respectively, P = 0.358) were similar between secondary covered and uncovered stents. Longer patients’ survival time (≥100 days) was associated with increased risk of stent malfunction (odds ratio: 4.598; 95% confidence interval: 1.473–14.355; P = 0.009).

Conclusions

Secondary stent-in-stent self-expanding metal stent placement is feasible and effective treatment for primary stent malfunctions in malignant gastric outlet obstruction. Covered and uncovered stent are equally acceptable in terms of stent-related complications and stent patency, regardless of primary stent type.     

A novel buddy balloon technique to recross a T‐stented bifurcation

The T technique is not uncommonly used to stent bifurcation lesions. It requires recrossing into the side branch with a guidewire and balloon to perform final Kissing Balloon dilations, but recrossing can be difficult. We describe a case of bifurcation stenting where balloon recrossing following guidewire placement into the side branch proved very challenging, and was finally achieved via a combination of forward pressure on a low‐profile balloon with its tip wedged at the stent struts along with simultaneous low‐pressure inflation of a larger parallel balloon. This altered the stent architecture and also allowed for a more favorable vector of force transmission to allow recrossing and hence successful completion of the procedure. © 2009 Wiley‐Liss, Inc.     

Comparison of frequency and severity of longitudinal stent deformation among various drug-eluting stents: An intravascular ultrasound study

Background

Longitudinal stent deformation (LSD) in drug-eluting stents (DES) has been described as a disruption of stent structure. This study aimed to compare first- versus second-generation DES with respect to their actual stent length post deployment.

Methods

A total of 617 DES for de novo coronary lesions in 552 patients were analyzed. Intravascular ultrasound (IVUS) was utilized to compare the degree and rate of LSD among six different DES types. IVUS-measured stent length was compared to the labeled length for calculation of absolute difference in stent length and relative absolute difference (absolute difference divided by the labeled length).

Results

The baseline characteristics were comparable between groups, except for higher calcification in the sirolimus-eluting stent (SES) group (p = 0.037). The absolute and relative difference in length showed the lowest degree in the SES group and the highest degree in the Endeavor zotarolimus-eluting stent group (p = 0.085 and 0.078, respectively). The percentage of more than 5% relative absolute difference was the lowest in the SES group compared to the other groups (p = 0.018). However, the percentage of significant (> 15%) relative absolute difference was similar among groups (p = 0.99). In multivariate linear regression analysis, labeled stent length and stent diameter, but not stent type, were identified as independent correlates to the absolute and relative difference in the actual stent length post-deployment.

Conclusion

This IVUS analysis confirms that among second-generation DES, there is overall similar frequency and severity of LSD when deploying in common coronary lesions.     

Tornus catheter and rotational atherectomy in resistant chronic total occlusions

Background

Although the inability to cross the chronic total occlusion (CTO) with a guidewire is the most common reason for failure, one of the most frustrating situations that may occur during a recanalization procedure is when a guidewire crosses successfully but it is impossible to advance any device over the wire through the occluded segment. We assessed the application of the Tornus catheter and/or rotational atherectomy to improve the success rate of percutaneous recanalization of CTO.

Methods

From October 2009 to May 2011, 55 consecutive patients with CTO resistant to recanalization by conventional techniques were treated by the following step-by-step approach: 1) Tornus catheter and 2) eventual high speed rotational atherectomy.

Results

Twenty-four lesions were successfully crossed by the Tornus catheter (43.5%). Rotational atherectomy was used in 31 patients (one with Tornus success and 30 with Tornus failure). A final angiographic success was obtained in 50/55 patients (91%) whereas in 5 patients both bail-out strategies failed (9%). As compared to the 24 CTO successfully treated by the Tornus catheter (Tornus-success group), the 31 patients in the Tornus-failure group were treated more often with the 2.1 F Tornus catheter and had more severely calcified lesions. By multivariable regression analysis the single independent predictor of Tornus failure was the presence of severely calcified lesions.

Conclusions

The Tornus catheter is a safe and effective device allowing us to overcome the inability to cross a CTO with a balloon catheter in approximately 45% of cases. In severely calcified CTO rotational atherectomy should be performed first.     

Quantitative assessment of tissue prolapse on optical coherence tomography and its relation to underlying plaque morphologies and clinical outcome in patients with elective stent implantation

Background

Tissue prolapse (TP) is sometimes observed after percutaneous coronary intervention (PCI), but its clinical significance remains unclear. We investigated the relationship between TP volume on optical coherence tomography (OCT) after PCI and underlying plaque morphologies and the impact of TP on clinical outcomes.

Methods

We investigated 178 native coronary lesions with normal pre-PCI creatine kinase-myocardial band (CK-MB) values (154 lesions with stable angina; 24 with unstable angina). TP was defined as tissue extrusion from stent struts throughout the stented segments. All lesions were divided into tertiles according to TP volume. The differences in plaque morphologies and 9-month clinical outcomes were evaluated.

Results

TP volume was correlated with lipid arc (r = 0.374, p < 0.0001) and fibrous cap thickness (r = − 0.254, p = 0.001) at the culprit sites. The frequency of thin-cap fibroatheroma (TCFA) was higher in the largest TP tertile (≥ 1.38 mm³) (p = 0.015). In multivariate analysis, right coronary artery lesion (odds ratio [OR]: 2.779; p = 0.005), lesion length (OR: 1.047; p = 0.003), and TCFA (OR: 2.430; p = 0.022) were related to the largest TP tertile. Lesions with post-PCI CK-MB elevation (> upper reference limit) had larger TP volume than those without (1.28 [0.48 to 3.97] vs. 0.70 [0.16 to 1.64] mm³, p = 0.007). The prevalence of cardiac events during the 9-month follow-up was not significantly different according to TP volume.

Conclusions

TP volume on OCT was related to plaque morphologies and instability, and post-PCI myocardial injury, but not to worse 9-month outcomes.     

Factors associated with reduced insertion depth at double balloon enteroscopy: A retrospective,multivariate analysis

Background

Deep small bowel insertion during double balloon enteroscopy can be difficult to achieve.

Aims

To determine the factors influencing depth of insertion during double balloon enteroscopy.

Methods

History of abdomino-pelvic surgery, route of insertion, type of enteroscope, age, sedation or general anaesthesia used and gender were considered as potential influencing factors; procedures were categorised accordingly and maximal depth of insertion calculated.

Results

At multivariate analysis, maximal depth of insertion was significantly associated with history of abdominal-pelvic surgery (P < 0.001), rectal approach (P = 0.011), gender (P = 0.02) and use of the therapeutic enteroscope (P = 0.047). Mean maximal depth of insertion was 266 ± 12 cm, 255 ± 9 cm (P = 0.50), 197 ± 10 cm (P < 0.0001), 160 ± 12 cm (P < 0.01) and 103 ± 33 cm (P < 0.15) when 0, 1, 2, 3 and 4 influencing factors were present, respectively.

Conclusion

Maximal depth of insertion was significantly influenced by history of abdomino-pelvic surgery, insertion route, gender and type of enteroscope used.     

Seguimiento de 3 años de pacientes con lesiones de bifurcación tratados con stents liberadores de sirolimus o everolimus: estudio de colaboración de SEAside y CORpal

Introduction and objectives

To compare the 3-year incidence of major events in patients with bifurcation lesions treated with provisional sirolimus-eluting stents vs everolimus-eluting stents.

Methods

A pooled analysis of 2 prospective randomized trials with similar methodology (SEAside and CORpal) was performed. In these trials, 443 patients with bifurcation lesions were randomly assigned to treatment with either sirolimus-eluting stents or everolimus-eluting stents. The clinical follow-up was extended up to 3 years to assess major adverse cardiovascular events (death or acute myocardial infarction or target vessel revascularization).

Results

At 3 years, survival free of major adverse cardiovascular events was 93.2% vs 91.3% in the everolimus-eluting stent group vs the sirolimus-eluting stent group (P = .16). Exploratory land-mark analysis for late events (occurring after 12 months) showed significantly fewer major adverse cardiovascular events in the everolimus-eluting stent group: 1.4% vs 5.4% in the sirolimus-eluting stent group (P = .02).

Conclusions

Provisional stenting with either sirolimus-eluting stents or everolimus-eluting stents in bifurcation lesions is associated with low rates of major adverse events at 3-years’ follow-up. The results of a subanalysis of events beyond 1 year, showing a lower event rate with everolimus-eluting stents than with sirolimus-eluting stents, suggest that studies exploring the long-term clinical benefit of the latest generation of drug-eluting stents are warranted.Full English text available from: www.revespcardiol.org/en     

Transapical mitral valved stent implantation: Enhanced survival and decreased paravalvular leakages

Background/Objectives

This study presents the recent results of transapical implantation of a new design of a mitral valved stent with up to three months follow-up.

Methods

A self-expanding re-designed mitral valved stent was implanted via transapical approach into the beating heart of eight pigs. Echocardiographic- and hemodynamic parameters were assessed before (n = 8), at 1 h (n = 8), at one month (n = 6), at two months (n = 2), and at three months (n = 1) after implantation and a cardiac CT was conducted.

Results

The stent was successfully deployed in all animals. Two animals died within the first month due to incorrect fixation force. Echocardiographic evaluation showed low gradients (3.9 ± 1.4 mm Hg and 1.9 ± 0.8 mm Hg across the valved stent and aortic valve) and a normal mitral annular plane systolic excursion (1.1 ± 0.2 cm) after one month. No paravalvular leakages (PVL) were detected after 1 h. The pulmonary artery pressure did not increase after valved stent implantation (p ≥ 0.106). The pulmonary capillary wedge pressure (PCWP) slightly increased to 16 ± 3 mm Hg after one month (p = 0.033). The left ventricular end-diastolic pressure was mildly elevated (15.8 ± 8.6 mm Hg) after one month.

Conclusions

Secure deployment and correct position of the valved stents were reproducibly achieved in the off-pump implantation procedure. No paravalvular leakages after 1 h as well as low gradients, few stent fractures and a normal longitudinal function after one month were achieved with this newly developed and well-aligned prototype. However, a number of challenges have been identified during this study and potential for improvement has been identified.