Prognostic Value of Histopathological Thrombus Age in Large Vessel Occlusion-Related Stroke.

INTRODUCTION: Acute mechanical thrombectomy (MT) is the preferred treatment for large vessel occlusion-related stroke. Histopathological research on the obtained occlusive embolic thrombus may provide information regarding the aetiology and pathology of the lesion to predict prognosis and propose possible future acute ischaemic stroke therapy. METHODS: A total of 75 consecutive patients who presented to the Amphia Hospital with acute large vessel occlusion-related stroke and underwent MT were included in the study. The obtained thrombus materials were subjected to standard histopathological examination. Based on histological criteria, they were considered fresh (<1 day old) or old (>1 day old). Patients were followed for 2 years for documentation of all-cause mortality. RESULTS: Thrombi were classified as fresh in 40 patients (53%) and as older in 35 patients (47%). Univariate Cox regression analysis showed that thrombus age, National Institutes of Health Stroke Scale at hospital admission, and patient age were associated with long-term mortality (p < 0.1). Multivariable Cox hazards and Kaplan-Meier analysis demonstrated that after extensive adjustment for clinical and procedural variables, thrombus age persisted in being independently associated with higher long-term mortality (hazard ratio: 3.34; p = 0.038, log-rank p = 0.013). CONCLUSION: In this study, older thromboemboli are responsible for almost half of acute large ischaemic strokes. Moreover, the presence of an old thrombus is an independent predictor of mortality in acute large vessel occlusion-related stroke. More research is warranted regarding future therapies based on thrombus composition.

Professionals' views on shared decision-making in severe aortic stenosis.

OBJECTIVE: To provide insight into professionals' perceptions of and experiences with shared decision-making (SDM) in the treatment of symptomatic patients with severe aortic stenosis (AS). METHODS: A semistructured interview study was performed in the heart centres of academic and large teaching hospitals in the Netherlands between June and December 2020. Cardiothoracic surgeons, interventional cardiologists, nurse practitioners and physician assistants (n=21) involved in the decision-making process for treatment of severe AS were interviewed. An inductive thematic analysis was used to identify, analyse and report patterns in the data. RESULTS: Four primary themes were generated: (1) the concept of SDM, (2) knowledge, (3) communication and interaction, and (4) implementation of SDM. Not all respondents considered patient participation as an element of SDM. They experienced a discrepancy between patients' wishes and treatment options. Respondents explained that not knowing patient preferences for health improvement hinders SDM and complicating patient characteristics for patient participation were perceived. A shared responsibility for improving SDM was suggested for patients and all professionals involved in the decision-making process for severe AS. CONCLUSIONS: Professionals struggle to make highly complex treatment decisions part of SDM and to embed patients' expectations of treatment and patients' preferences. Additionally, organisational constraints complicate the SDM process. To ensure sustainable high-quality care, professionals should increase their awareness of patient participation in SDM, and collaboration in the pathway for decision-making in severe AS is required to support the documentation and availability of information according to the principles of SDM.

Percutaneous atrial shunt closure using the novel Occlutech Figulla device: 6-month efficacy and safety.

BACKGROUND: The Occlutech Figulla Occluder is a new innovative device for percutaneous closure of a patent foramen ovale (PFO) and an atrial septum defect (ASD). We describe the safety and efficacy of this new device at 6-month follow-up. METHODS: All 82 consecutive patients (51% female, mean age 49.0 ± 13.6 years) who underwent percutaneous PFO (n = 48) or ASD (n = 34) closure between October 2008 and October 2009 were included. RESULTS: Implantation success was 100%. The in-hospital complications were two new onset supraventricular tachycardia (SVT) (2.4%, both ASD patients), nine minimal groin hematoma's (11.0%, 4 PFO and 5 ASD patients), and one transient ST elevation during the procedure (1.2%, ASD patient). During 6 months follow-up (n = 79), no major complications or reoccurrences of cerebral thrombo-embolic events did occur. Seven patients (8.9%, 6 PFO and 1 ASD patient) experienced a new SVT. One patient developed a recurrent cerebral hemorrhage 5 months after ASD closure, which appeared not to be related to the procedure. Using contrast transthoracic echocardiography 6 months after PFO closure (n = 45), a residual shunt was present in 30.2% of the patients (small 25.6%, moderate 4.6%, severe 0%). In the ASD group (n = 34), a residual shunt was observed in 32.5% (small 17.7%, moderate 14.7%, severe 2.9%). CONCLUSION: The Occlutech Figulla Occluder appears to be easy to use, effective, and safe for percutaneous closure of PFO and ASD. We report a low complication rate but a relative high percentage of small residual shunts 6 months after closure.

Use of Lithotripsy in a Calcified Saphenous Vein Graft.

Percutaneous coronary interventions in saphenous vein grafts can pose a variety of challenges, such as severely calcified lesions. If these lesions are nondilatable, lithotripsy can arguably be a proper tool for lesion preparation. We present a case in which a nondilatable, calcified saphenous vein graft was successfully treated using Shockwave lithotripsy. (Level of Difficulty: Intermediate.).

Comparison of Outcome After Percutaneous Mitral Valve Repair With the MitraClip in Patients With Versus Without Atrial Fibrillation.

Percutaneous mitral valve repair with the MitraClip is an established treatment for patients with mitral regurgitation (MR) who are inoperable or at high risk for surgery. Atrial Fibrillation (AF) frequently coincides with MR, but only scarce data of the influence of AF on outcome after MitraClip is available. The aim of the current study was to compare the clinical outcome after MitraClip treatment in patients with versus without atrial fibrillation. Between January 2009 and January 2016, all consecutive patients treated with a MitraClip in 5 Dutch centers were included. Outcome measures were survival, symptoms, MR grade, and stroke incidence. In total, 618 patients were treated with a MitraClip. Patients with AF were older, had higher N-terminal B-type natriuretic peptide levels, more tricuspid regurgitation, less often coronary artery disease and a better left ventricular function. Survival of patients treated with the MitraClip was similar for patients with AF (82%) and without AF (non-AF; 85%) after 1 year (p = 0.30), but significantly different after 5-year follow-up (AF 34%; non-AF 47%; p = 0.006). After 1 month, 64% of the patients with AF were in New York Heart Association class I or II, in contrast to 77% of the patients without AF (p = 0.001). The stroke incidence appeared not to be significantly different (AF 1.8%; non-AF 1.0%; p = 0.40). In conclusion, patients with AF had similar 1-year survival, MR reduction, and stroke incidence compared with non-AF patients. However, MitraClip patients with AF had reduced long-term survival and remained more symptomatic compared with those without AF.

Three-year clinical outcome in the Primary Stenting of Totally Occluded Native Coronary Arteries III (PRISON III) trial: a randomised comparison between sirolimus-eluting stent implantation and zotarolimus-eluting stent implantation for the treatment of total coronary occlusions.

AIMS: Sirolimus-eluting stents (SES) have been shown to be superior to Endeavor zotarolimus-eluting stents (ZES) and comparable to Resolute ZES at eight-month angiography in patients treated for total coronary occlusions (TCO). This study investigated clinical outcome at three-year follow-up. METHODS AND RESULTS: The PRISON III trial investigated the efficacy and safety of SES against ZES (Endeavor and Resolute) in two study phases. In the first phase, 51 patients were randomised to receive SES and 46 to Endeavor ZES. In the second phase, 103 and 104 patients were randomised to SES or Resolute ZES, respectively. Between one and three years there were only a few additional clinical events in all groups. As a result, the rates of target lesion revascularisation 12.2% vs. 19.6%, p=0.49, target vessel failure 14.3% vs. 19.6%, p=0.68, and definite or probable stent thrombosis 4.1% vs. 2.2% were comparable between SES and Endeavor ZES at three years. In the second study phase, the rates of target lesion revascularisation 10% vs. 5.9%, p=0.42, target vessel failure 10% vs. 7.9%, p=0.79 and definite or probable stent thrombosis 1.0% vs. 0% were similar between SES and Resolute ZES. CONCLUSIONS: The present study demonstrated a low incidence of clinical events between one- and three-year follow-up with either SES compared to Endeavor ZES or SES versus Resolute ZES in patients treated for total coronary occlusions.

Late catch-up in lumen diameter at five-year angiography in MACE-free patients treated with sirolimus-eluting stents in the Primary Stenting of Totally Occluded Native Coronary Arteries: a randomised comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions (PRISON II).

AIMS: The present study was designed to examine the five-year angiographic follow-up of MACE-free patients enrolled in the PRISON II study. METHODS AND RESULTS: In the PRISON II study a total of 200 patients were randomised to either bare metal stents (BMS) or sirolimus-eluting stents (SES) after successful recanalisation of total coronary occlusions (TCO). Patients free of MACE with available angiography at six months were approached for repeated angiography at five years. The primary endpoint was in-stent very late luminal loss (VLLL) at five years. The secondary endpoint was additional late luminal loss (ALLL) between six months and five years. At five years, repeated angiography was performed in 72 patients, 50/82 (61%) in the SES group and 22/58 (38%) in the BMS group. In-stent VLLL was lower in the SES group (0.19 mm ± 0.72 vs. 0.51 mm ± 0.71, p=0.09) compared to the BMS group and in-segment VLLL was comparable in both groups (0.01 mm±0.58 vs. 0.03 mm ± 0.73, p=0.89). Late catch-up in lumen diameter was observed in the SES group with a trend towards increased ALLL compared to the BMS group (in-stent, 0.35 mm ± 0.88 vs. 0.04 mm ± 0.81, p=0.16; in-segment, 0.20 mm ± 0.74 vs. -0.05 mm ± 0.73, p=0.19). CONCLUSIONS: At five-year angiographic follow-up, late catch-up was observed after successful recanalisation of TCOs treated with SES. Despite a late catch-up, the angiographic results of SES were superior in-stent and similar in-segment compared to BMS.

Primary Stenting of Totally Occluded Native Coronary Arteries III (PRISON III): a randomised comparison of sirolimus-eluting stent implantation with zotarolimus-eluting stent implantation for the treatment of total coronary occlusions.

AIMS: We investigated whether sirolimus-eluting stents (SES) are superior to next-generation zotarolimus-eluting stents (ZES) in treating patients with total coronary occlusions (TCO). METHODS AND RESULTS: In a prospective, randomised trial we compared the SES with the zotarolimus-eluting stent (ZES; Endeavor or Resolute) after successful recanalisation of TCO. During the first phase of the trial, 51 patients were assigned to receive the SES and 46 patients to receive the Endeavor ZES. In the second phase we randomised 103 patients to the SES group and 104 patients to the Resolute ZES group. The primary endpoint was in-segment late lumen loss at eight-month follow-up. At eight months, patients in the SES group had less in-segment and in-stent late loss as compared to the Endeavor group: -0.13±0.3 mm vs. 0.27±0.6 mm (p=0.0002) and -0.13±0.5 mm vs. 0.54±0.5 mm (p<0.0001), respectively. In contrast, the SES and the Resolute ZES showed comparable amounts of in-segment (-0.03±0.7 mm vs. -0.10±0.7 mm, p=0.6) and in-stent (0.03±0.8 mm vs. 0.05±0.8 mm, p=0.9) late loss. CONCLUSIONS: In the treatment of TCOs, the SES was associated with superior angiographic outcomes compared to the Endeavor ZES. On the other hand, the SES and the Resolute ZES showed comparable angiographic outcomes.

Five-year clinical outcome after primary stenting of totally occluded native coronary arteries: a randomised comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions (PRISON II study).

AIMS: The aim of this study was to examine the five-year clinical outcome in patients enrolled in the Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II) study. METHODS AND RESULTS: Patients with totally occluded coronary arteries were randomised to either sirolimus-eluting stent (SES, n=100) or bare metal stent (BMS, n=100) implantation. At five years, patients in the SES group had significantly lower rates of target lesion revascularisation (12% vs. 30%, p=0.001), target vessel revascularisation (17% vs. 34%, p=0.009) and major adverse cardiac events (12% vs. 36%, p<0.001). There were no significant differences in death and myocardial infarction. Eight (8%) cases of stent thrombosis (seven definite and one probable; one early, one late, and six very late) were noticed in the SES group versus three cases (3%, one definite and two possible; all very late) in the BMS group (p=0.21). CONCLUSIONS: The results of the present study show that the documented superior short-term angiographic and clinical results of SES in patients with total coronary occlusions are maintained during long-term 5-year follow-up as compared with BMS. On the other hand, there is a trend to a higher stent thrombosis rate in the SES group.

Percutaneous edge-to-edge mitral valve repair in high-surgical-risk patients: do we hit the target?

OBJECTIVES: This study sought to assess the feasibility and safety of percutaneous edge-to-edge mitral valve (MV) repair in patients with an unacceptably high operative risk. BACKGROUND: MV repair for mitral regurgitation (MR) can be accomplished by use of a clip that approximates the free edges of the mitral leaflets. METHODS: All patients were declined for surgery because of a high logistic EuroSCORE (>20%) or the presence of other specific surgical risk factors. Transthoracic echocardiography was performed before and 6 months after the procedure. Differences in New York Heart Association (NYHA) functional class, quality of life (QoL) using the Minnesota questionnaire, and 6-min walk test (6-MWT) distances were reported. RESULTS: Fifty-five procedures were performed in 52 patients (69.2% male, age 73.2 ± 10.1 years, logistic EuroSCORE 27.1 ± 17.0%). In 3 patients, partial clip detachment occurred; a second clip was placed successfully. One patient experienced cardiac tamponade. Two patients developed inguinal bleeding, of whom 1 needed surgery. Six patients (11.5%) died during 6-month follow-up (5 patients as a result of progressive heart failure and 1 noncardiac death). The MR grade before repair was ≥3 in 100%; after 6 months, a reduction in MR grade to ≤2 was present in 79% of the patients. Left ventricular (LV) end-diastolic diameter, LV ejection fraction, and systolic pulmonary artery pressure improved significantly. Accompanied improvements in NYHA functional class, QoL index, 6-MWT distances, and log N-terminal pro-B-type natriuretic peptide were observed. CONCLUSIONS: In a high-risk population, MR reduction can be achieved by percutaneous edge-to-edge valve repair, resulting in LV remodeling with improvement of functional capacity after 6 months.

A randomized multicenter comparison of hybrid sirolimus-eluting stents with bioresorbable polymer versus everolimus-eluting stents with durable polymer in total coronary occlusion: rationale and design of the Primary Stenting of Occluded Native Coronary Arteries IV study.

BACKGROUND: Percutaneous recanalization of total coronary occlusion (TCO) was historically hampered by high rates of restenosis and reocclusions. The PRISON II trial demonstrated a significant restenosis reduction in patients treated with sirolimus-eluting stents compared with bare metal stents for TCO. Similar reductions in restenosis were observed with the second-generation zotarolimus-eluting stent and everolimus-eluting stent. Despite favorable anti-restenotic efficacy, safety concerns evolved after identifying an increased rate of very late stent thrombosis (VLST) with drug-eluting stents (DES) for the treatment of TCO. Late malapposition caused by hypersensitivity reactions and chronic inflammation was suggested as a probable cause of these VLST. New DES with bioresorbable polymer coatings were developed to address these safety concerns. No randomized trials have evaluated the efficacy and safety of the new-generation DES with bioresorbable polymers in patients treated for TCO. METHODS/DESIGN: The prospective, randomized, single-blinded, multicenter, non-inferiority PRISON IV trial was designed to evaluate the safety, efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with bioresorbable polymers (Orsiro; Biotronik, Berlin, Germany) compared with everolimus-eluting stents with durable polymers (Xience Prime/Xpedition; Abbott Vascular, Santa Clara, CA, USA) in patients with successfully recanalized TCOs. In total, 330 patients have been randomly allocated to each treatment arm. Patients are eligible with estimated duration of TCO ≥4 weeks with evidence of ischemia in the supply area of the TCO. The primary endpoint is in-segment late luminal loss at 9-month follow-up angiography. Secondary angiographic endpoints include in-stent late luminal loss, minimal luminal diameter, percentage of diameter stenosis, in-stent and in-segment binary restenosis and reocclusions at 9-month follow-up. Additionally, optical coherence tomography is performed in the first 60 randomized patients at 9 months to assess neointima thickness, percentage of neointima coverage, and stent strut malapposition and coverage. Personnel blinded to the allocated treatment will review all angiographic and optical coherence assessments. Secondary clinical endpoints include major adverse cardiac events, clinically driven target vessel revascularization, target vessel failure and stent thrombosis to 5-year clinical follow-up. An independent clinical event committee blinded to the allocated treatment will review all clinical events. TRIAL REGISTRATION: Clinical Trials.gov: NCT01516723. Patient recruitment started in February 2012.