Optical Coherence Tomography Findings in Patients With Coronary Stent Thrombosis: A Report of the PRESTIGE Consortium (Prevention of Late Stent Thrombosis by an Interdisciplinary Global European Effort).

BACKGROUND: Stent thrombosis (ST) is a serious complication following coronary stenting. Intravascular optical coherence tomography (OCT) may provide insights into mechanistic processes leading to ST. We performed a prospective, multicenter study to evaluate OCT findings in patients with ST. METHODS: Consecutive patients presenting with ST were prospectively enrolled in a registry by using a centralized telephone registration system. After angiographic confirmation of ST, OCT imaging of the culprit vessel was performed with frequency domain OCT. Clinical data were collected according to a standardized protocol. OCT acquisitions were analyzed at a core laboratory. Dominant and contributing findings were adjudicated by an imaging adjudication committee. RESULTS: Two hundred thirty-one patients presenting with ST underwent OCT imaging; 14 (6.1%) had image quality precluding further analysis. Of the remaining patients, 62 (28.6%) and 155 (71.4%) presented with early and late/very late ST, respectively. The underlying stent type was a new-generation drug-eluting stent in 50.3%. Mean reference vessel diameter was 2.9±0.6 mm and mean reference vessel area was 6.8±2.6 mm2. Stent underexpansion (stent expansion index <0.8) was observed in 44.4% of patients. The predicted average probability (95% confidence interval) that any frame had uncovered (or thrombus-covered) struts was 99.3% (96.1-99.9), 96.6% (92.4-98.5), 34.3% (15.0-60.7), and 9.6% (6.2-14.5) and malapposed struts was 21.8% (8.4-45.6), 8.5% (4.6-15.3), 6.7% (2.5-16.3), and 2.0% (1.2-3.3) for acute, subacute, late, and very late ST, respectively. The most common dominant finding adjudicated for acute ST was uncovered struts (66.7% of cases); for subacute ST, the most common dominant finding was uncovered struts (61.7%) and underexpansion (25.5%); for late ST, the most common dominant finding was uncovered struts (33.3%) and severe restenosis (19.1%); and for very late ST, the most common dominant finding was neoatherosclerosis (31.3%) and uncovered struts (20.2%). In patients presenting very late ST, uncovered stent struts were a common dominant finding in drug-eluting stents, and neoatherosclerosis was a common dominant finding in bare metal stents. CONCLUSIONS: In patients with ST, uncovered and malapposed struts were frequently observed with the incidence of both decreasing with longer time intervals between stent implantation and presentation. The most frequent dominant observation varied according to time intervals from index stenting: uncovered struts and underexpansion in acute/subacute ST and neoatherosclerosis and uncovered struts in late/very late ST.

Left ventricular function and clinical outcome in transient left ventricular ballooning syndrome.

BACKGROUND: It is unknown if the severity of left ventricular dysfunction in patients with transient left ventricular ballooning syndrome (TLVBS) adversely affects clinical outcome. Furthermore, it remains unclear if the patterns of ventricular involvement are distinct patterns or if they represent varying stages of ventricular involvement. METHODS AND RESULTS: All patients with TLVBS who presented to our hospital from August 1998 to August 2012 were prospectively identified and entered into a clinical database. Available ventriculograms were reviewed, the ejection fraction (EF) calculated and a new severity score of left ventricular (LV) involvement was developed to determine the degree of LV dysfunction. The incidence of in-hospital mortality, cardiogenic shock and major cardiac events (heart failure/pulmonary oedema or major cardiac arrhythmia) was recorded. In total, 145 TLVBS episodes were identified in 139 patients. Age at presentation was 67 ± 12 years and 89% (n = 123) of patients were female. Patients who developed cardiogenic shock or other acute cardiac events had a worse LVEF compared to those who did not (P < 0.01 and P = 0.05, respectively). In-hospital mortality was not related to worse EF (P = 0.58). In-hospital and 1-year mortality rates were 6.9% and 12.6%, respectively. Median time from symptom onset to clinical diagnosis was similar between the apical ballooning (n = 104; 12 [3-30] hours) and the mid-ventricular ballooning group (n = 25; 11 [4-35] hours, P = 0.97). CONCLUSIONS: In TLVBS patients the severity of LV dysfunction determines the incidence of cardiogenic shock and early cardiac events. Apical and mid-ventricular forms of TLVBS appear to be distinct patterns.

Unusual stent fracture: diagnosis with optical coherence tomography.

: We report an unusual case of new-generation drug-eluting stent fracture, diagnosed and managed with aid of optical coherence tomography.

COmplex coronary Bifurcation lesions: RAndomized comparison of a strategy using a dedicated self-expanding biolimus-eluting stent versus a culotte strategy using everolimus-eluting stents: primary results of the COBRA trial.

AIMS: We aimed to compare healing responses with optical coherence tomography, and clinical and angiographic outcome after treatment of coronary bifurcation lesions with a dedicated stent versus a conventional culotte technique. METHODS AND RESULTS: Forty patients with true and complex coronary bifurcation lesions were randomly assigned to treatment with the Axxess™ bifurcation stent in the proximal main vessel (MV) and additional BioMatrix™ stents in the branches (Biosensors Europe SA, Morges, Switzerland), versus a culotte technique using XIENCE™ stents (Abbott Vascular, Santa Clara, CA, USA). The primary endpoint of percentage of uncovered struts at nine months was similar with the dedicated strategy vs. culotte in the proximal MV (median 17.8 [IQR 3.3-24.7] vs. 6.8 [2.0-20.5]; p=0.19), bifurcation core (9.5 [5.7-19.5] vs. 4.0 [0.7-17.6]; p=0.17), distal MV (2.6 [2.3-18] vs. 2.2 [0.5-6.0]; p=0.09) and side branch (5.7 [1.5-11.5] vs. 1.9 [0-5.8]; p=0.14). As compared with culotte, a strategy using Axxess resulted in a significantly larger lumen in the proximal MV both acutely (minimum lumen diameter 3.03±0.51 vs. 2.71±0.44 mm, p=0.04) and at follow-up (mean lumen area 10.0±2.1 vs. 7.1±1.8 mm2, p<0.001), and in a lower angiographic late lumen loss (p=0.05). Both strategies resulted in good clinical outcomes at one year, and no stent thromboses. CONCLUSIONS: As compared with a culotte strategy with XIENCE stents, complex bifurcation stenting using a dedicated strategy combining Axxess and BioMatrix stents results in similar stent strut coverage at nine-month follow-up, and a significantly larger lumen and lower angiographic late lumen loss in the proximal MV.

STACCATO (Assessment of Stent sTrut Apposition and Coverage in Coronary ArTeries with Optical coherence tomography in patients with STEMI, NSTEMI and stable/unstable angina undergoing everolimus vs. biolimus A9-eluting stent implantation): a randomised controlled trial.

AIMS: To compare tissue coverage in coronary lesions stented with durable fluoropolymer-coated everolimus-eluting stents (EES) vs. biodegradable polymer-coated biolimus A9-eluting stents (BES). METHODS AND RESULTS: Sixty-four patients (64 lesions) with de novo coronary artery lesions were randomised to percutaneous treatment with XIENCE EES (Abbott Vascular, Santa Clara, CA, USA) vs. BioMatrix BES (Biosensors, Morges, Switzerland). The primary endpoint was the percentage of uncovered struts, as assessed with OCT, at nine months. The average percentage of uncovered struts was significantly lower with EES (4.3±4.8% vs. 8.7±7.8% with BES, p=0.019). There was no difference in the average percentage of malapposed struts at baseline (6.8±6.9% vs. 6.9±7.0%, respectively, p=0.974) and at follow-up (0.1±0.3% vs. 0.6±1.3%, p=0.143). Neointimal thickness at nine months was 109±43 µm in EES vs. 64±18 µm in BES (p<0.001), and angiographic LLL was 0.15 mm in EES vs. 0.10 mm in BES (p=0.581). We did not observe differences in the incidence of MACE and ST. CONCLUSIONS: A significantly higher percentage of uncovered struts was detected in the BioMatrix BES compared with the XIENCE EES at nine-month follow-up. Our findings do not support a preferential use of stents with biodegradable polymer-based biolimus elution to reduce the risk for ST.

Additional tricuspid annuloplasty in mitral valve surgery results in better clinical outcome.

OBJECTIVE: The clinical benefit of tricuspid annuloplasty (TA) in patients undergoing mitral valve surgery (MVS) is still debated. We evaluated the immediate surgical success, postoperative outcome and the medium-term effect of TA in MVS. METHODS: Patients were included between September 2003 and December 2009 and followed until September 2013 to achieve a median follow-up time of 5 years (IQR 3.7-6.9). The end point of mortality due to cardiac causes and combined end point of cardiac mortality or hospitalisation for heart failure were evaluated. Propensity score adjusted Cox regression was used to evaluate the clinical benefit of TA at the time of MVS. RESULTS: Of 150 patients (84 female; 67±12 years), 82 presented with tricuspid regurgitation (TR) <2/4 and underwent isolated MVS. Of 68 patients presenting with TR≥2/4, 31 underwent isolated MVS whereas 37 underwent additional TA. In patients with preoperative TR≥2/4, TR was significantly reduced until 5 years postoperatively (mean reduction 0.81±1.31; p=0.04) when additional TA was done. The combined end point occurred in 29% vs 6% at 1 year and in 57% vs 39% at 5 years follow-up for patients with isolated MVS and patients undergoing concomitant TA, respectively. Patients with preoperative TR≥2/4 had worse unadjusted survival than those with TR<2/4 (logrank p=0.009). In the patients with TR≥2/4, propensity score-adjusted risk for the combined end point was higher in those with isolated MVS versus MVS with additional TA (Cox HR 2.855 (1.082-7.532), p=0.035). CONCLUSIONS: Additional TA is an effective surgical measure to reduce functional TR severity. This approach results in a decreased risk of cardiac mortality and hospitalisation in patients with preoperative TR≥2/4.

The apical nipple sign: a useful tool for discriminating between anterior infarction and transient left ventricular ballooning syndrome.

AIMS: Even after coronary angiography, transient left ventricular ballooning syndrome (TLVBS) can be misdiagnosed as ST-elevation myocardial infarction (STEMI) caused by transient thrombotic occlusion of the left anterior descending artery, as the appearance of the left ventricular angiograms is often very similar. As prognosis and antithrombotic treatment of these two conditions differ widely, it is desirable to make a correct diagnosis as early as possible. METHODS: Between January 1998 and August 2012, we identified 145 patients diagnosed with TLVBS in a single tertiary hospital, based on the Mayo criteria and (near) normalization of left ventricular function over weeks. For 119 of these patients, coronary and left ventricular angiograms were available for detailed study. RESULTS: In 27 (22.7%) patients, mid-ventricular ballooning was observed, with preserved contractility of the apex, while in 92 (77.3%) typical apical ballooning was seen, with extensive akinesis of the apex. In 28 of the patients with typical apical ballooning (30.4%), we observed the presence of a very small zone with preserved contractility in the most apical portion of the left ventricle. We coined this phenomenon 'apical nipple sign'. For comparison, we reviewed the left ventricular angiograms of 405 patients who had been treated for anterior STEMI by emergency percutaneous intervention on the left anterior descending artery in our hospital between February 2007 and October 2012. On careful review, the apical nipple sign was not seen in any of these. CONCLUSION: While discrimination between TLVBS and anterior STEMI is warranted as early as possible after admission, this is very difficult, especially in the majority of cases presenting with the classical apical ballooning phenotype. By observing the herein-described apical nipple sign, the attending physician can make the diagnosis of TLVBS with virtual certainty in almost one-third of cases.

Healing course of acute vessel wall injury after drug-eluting stent implantation assessed by optical coherence tomography.

BACKGROUND: Vessel wall injury after drug-eluting stent (DES) implantation can be characterized in detail by optical coherence tomography (OCT). Little is known about the healing course of these phenomena. METHODS AND RESULTS: In 62 lesions (62 patients), the incidence of acute vessel trauma was assessed in the stented region and the edge segments immediately after DES implantation. The healing course of these injuries was assessed at 9-month OCT follow-up using a software algorithm allowing for reliable spatial comparison of baseline and follow-up cross-sectional images. Tissue prolapse (TP) and tissue protrusions were detected in 81 and 35% of lesions, respectively. A total of 342 intra-stent dissection flaps (ISD) and 114 intra-stent dissection cavities (ISC) were visualized in 98 and 81% of lesions, respectively. Thirty-five lesions (56%) showed edge dissections (EDs). No residual TP or protrusion was observed at follow-up. Incomplete healing was seen in 8% of ISD and in 20% of ISC. For ED, a residual flap was observed in one-third of the initially dissected stent edges. Incomplete healing of acute vessel injury was associated with the presence of underlying atherosclerotic disease at baseline. Uncovered and malapposed stent struts were observed more often with incomplete healing of vessel injury at follow-up. CONCLUSIONS: Acute vessel wall trauma is highly prevalent immediately after DES implantation. Most of these injuries are minor and resolve at mid-term follow-up. Incomplete healing of ISDs seems to be associated with other OCT findings suggesting delayed arterial healing.

Automated detection and quantification of clusters of malapposed and uncovered intracoronary stent struts assessed with optical coherence tomography.

To date, accurate quantification and localization of malapposed and uncovered struts needs manual and time consuming analysis of large datasets. To develop an algorithm for automated detection and quantification of clusters of malapposed and uncovered struts in optical coherence tomography (OCT) pullbacks, including comprehensive information about their three-dimensional spatial distribution. 64 lesions in 64 patients treated with drug-eluting stent underwent assessment with OCT immediately after implantation and at 9-month follow-up (55 patients). An automated algorithm was used to detect and quantify stent strut malapposition at baseline and coverage at follow-up on an individual strut level. We subsequently applied an algorithm for the automated clustering of malapposed and uncovered struts and for the quantification of clusters' properties. In the 64 baseline examinations, a total of 24,013 struts were analyzed, of which 1,519 (6 %) were malapposed. Most malapposed struts (78 %) occurred in clusters and more than half of patients had malapposition clusters. The mean number of struts per cluster was 19.7 ± 11.8 with a mean malapposition distance of 213 ± 66 µm. In the 55 follow-up pullbacks, a total of 20,484 struts were analyzed, of which 1,320 (6 %) were uncovered. Again, most uncovered struts (85 %) occurred in clusters. The mean number of struts per cluster was 21.1 ± 14.7. We developed an automated algorithm for studying clustering of malapposed or uncovered struts. This algorithm might facilitate future investigations of the prognostic impact of clusters of malapposed or uncovered struts.