Anna Ścibisz

Incidence, Predictors and Impact of Severe Periprocedural Bleeding According to VARC-2 Criteria on 1-Year Clinical Outcomes in Patients After Transcatheter Aortic Valve Implantation

There are differences in reporting bleeding complications after transcatheter aortic valve implantation (TAVI), which is a consequence of the lack of consensus for their definition. Furthermore, the amount of data on the impact of peri-procedural bleeding on the mid-term prognosis is still limited. The aim of this study was to investigate the incidence, predictors, and impact of life-threatening and major bleedings as defined by the Valve Academic Research Consortium 2 (VARC-2) in patients after TAVI over the mid-term prognosis.Consecutive patients who underwent TAVI from March 2010 to December 2013 were included. All data were classified according to the VARC-2 criteria. We assessed the incidence and the predictors of serious bleeding events (SBE), defined as life-threatening/disabling (LT/D) or major bleeding, and analyzed their impact on 30-day and 1-year clinical outcome.A total of 129 patients were included (79.1 ± 8.3 years; mean EuroSCORE = 17.8 ± 12.7). The SBE occurred in 25 patients (19.4%), of which 9 (7.0%) had LT/D and 16 (12.4%) had major bleeding. Trans-subclavian (TS) access (OR 4.38, 95% CI 2.13-14.29, P = 0.01) and diabetes (OR 2.93, 95% CI 1.08-7.93, P = 0.03) were identified as independent predictors of SBE. Patients with SBE had higher 30-day mortality (20.0% versus 4.0% P = 0.02) and 1-year mortality (40.0% versus 11.1%, P < 0.002). SBE independently predicted 1-year, all-cause mortality (HR 5.88, 95% CI 1.7319,94, P = 0.005).SBE are frequent after TAVI and are associated with decreased short and mid-term survival. Diabetes and TS access are independent risk factors for SBE.

Access for percutaneous coronary intervention in ST segment elevation myocardial infarction: radial vs. femoral ??? a prospective, randomised clinical trial (OCEAN RACE)

BACKGROUND Percutaneous treatment of patients with ST segment elevation myocardial infarction (STEMI) has become the standard and default mode of management as recommended by the European Society of Cardiology guidelines for managing acute myocardial infarction in patients presenting with STEMI. The choice of vascular access is made by the operator and has a potential impact on the safety and efficacy of the procedure and outcomes. AIM To understand the influence of a radial approach on bleeding complications and angiographic success, we performed a prospective, controlled randomised trial. METHODS Patients were allocated to radial (TR) or femoral (TF) vascular access. The primary endpoints were major bleeding by the REPLACE-2 scale and minor bleeding by the EASY scale (TR arm) or the FEMORAL scale (TF arm). Other outcomes included procedural data, in-hospital and long-term survival. RESULTS There were 103 patients analysed in total, 52 in the TR arm and 51 in the TF arm. The demographic and clinical baseline characteristics were well matched between the two study groups. The frequency of the primary endpoint was the same in both arms (TR: 25.0% vs. TF: 33.3%, p = 0.238). In per protocol analysis, there was a significant benefit of the TR approach among independent operators (17.4% vs. 36.8%, p = 0.038). Major bleeding by the REPLACE-2 scale occurred in 4.2% of patients (TR: 5.8% vs. TF: 3.9%, p = 0.509). There were no differences in terms of the rate of major cardiac adverse events, which happened in 10.7% of the study population (TR: 9.6% vs. TF: 11.8%, p = 0.48). In the TF arm, there was a trend towards a higher risk of local bleedings (TR: 22.4% vs. TF: 37.7%, p = 0.081) and a significantly higher frequency of local haematoma (class III, EASY/FEMORAL) (TR: 0% vs. TF: 9.8%, p = 0.027). CONCLUSIONS There were no significant differences between the TR and TF approaches in terms of clinical efficacy and patient safety. However, patients treated by independent operators might benefit from TR access. The overall complication risk of percutaneous coronary intervention treatment of STEMI patients remains low.

A prospective randomised comparison of minor bleedings in transradial vs. transfemoral access percutaneous coronary interventions for STEMI: a new FEMORAL bleeding classification

BACKGROUND Local bleedings related to vascular access site in percutaneous procedures are relatively common complications. However, no uniform definitions exist to classify them. AIM To compare minor bleedings related to transradial (TR) and transfemoral (TF) percutaneous coronary intervention (PCI) approaches in ST elevation myocardial infarction (STEMI). In addition, a new classification of TF access-related bleeding - the FEMORAL scale - was proposed. METHODS OCEAN RACE is a prospective, randomised, open-label, clinical trial performed in STEMI patients treated with primary PCI. Patients were randomly assigned to the TR or TF arm. Bleedings related to the TR approach were assessed by the EASY scale, whereas bleedings related to the TF approach were classified according to the new FEMORAL scale. A combined analysis of all bleedings was performed using the TIMI scale. RESULTS There were 103 patients analysed, including 52 in the TR arm and 51 in the TF arm. Analysis of demographic and clinical baseline characteristics revealed no significant differences between the two study groups. In-hospital bleedings related to the access site were observed in 29.8% of patients. In the TR group, a trend towards lower risk of local bleedings was observed compared to the TF group (TR: 22.4% vs. TF: 37.7%, p = 0.081). Analysis of each class of access site bleeding according to EASY/FEMORAL scales showed that patients in the TR group had a significantly lower risk of class III local haematoma compared to the TF group (TR: 0% vs. TF: 9.8%, p = 0.027). The risk of bleeding in other classes was comparable in both groups. A trend towards less frequent minimal bleedings according to the TIMI scale was observed in the TR group (HR: 0.41, 95% CI: 0.152-1.112, p = 0.059). CONCLUSIONS TF patients had a higher risk of access-related bleedings than TR patients. The FEMORAL scale was effective in the classification of TF access-related bleedings. Although the popularity of TF access in PCI decreases, this approach is increasingly used in transcatheter aortic valve implantation, renal denervation and closure of paravalvular leaks. Therefore a scale accessing local bleeding in the TF approach may be useful.

Tissue coverage of paclitaxel and sirolimus eluting stents in long term follow-up: optical coherence tomography study.

BACKGROUND Implantation of drug eluting stents (DES) has become a standard treatment of patients undergoing percutaneous coronary intervention (PCI). Incomplete strut coverage is a potential risk factor for late stent thrombosis. Optical coherence tomography (OCT) enables in vivo identification of incomplete neointimal coverage. METHODS Study included 62 patients after sirolimus eluting stents (SES) or paclitaxel eluting stents (PES) implantation. OCT examination was performed at least 24 months after the initial procedure (35.4± 9.4 months). In cross-sectional still frames selected from each 1 mm of analyzed stents a total number of visible struts and number of struts with or without complete neointimal coverage was assessed. Measurements of neointimal coverage, presented as a mean thickness of tissue, were performed. Patients were followed up for 3 years and the frequency ofmajor adverse cardiac events was recorded. RESULTS In the analyzed 28 SES and 37 PES 9998 struts were identified. Complete neointimalcoverage was observed in 83.5% and 79.2% of SES and PES struts respectively (p = 0.48).There was no difference in incidence of not covered or malapposed struts between SES and PES groups. Mean thickness of the tissue covering SES struts was 0.165 ± 0.095 mm, and 0.157 ± 0.121 mm for PES. The mean neointimal thickness difference (SES vs. PES) was notstatistically significant. In a 36 months follow-up 1 death was observed - potentially attributed to stent thrombosis. CONCLUSIONS A long term OCT follow-up after DES implantation shows high incidence ofuncovered struts regardless of the stent type. Clinical significance of this finding remains questionable and requires further large scale trials.

Comparison between optical coherence tomography and intravascular ultrasound in detecting neointimal healing patterns after stent implantation

BACKGROUND The amount of data comparing intravascular ultrasound (IVUS) and optical coherence tomography (OCT) for the detection of stent coverage in clinical settings is limited. AIM To make a qualitative and quantitative assessment of the vascular healing patterns in patients after stent implantations visualised by both IVUS and OCT. METHODS Images were obtained in patients with clinical symptoms of angina, who had had a bare metal stent implanted in the previous 12 months. Angiography, IVUS and OCT were performed in 14 coronary arteries. Measurements of stent, lumen and neo-intima areas and dimensions were performed in stented regions and in both 10 mm references. IVUS, OCT, and angiographic data were compared in matched regions. Off-line analyses were performed by an independent core lab. RESULTS 14 stents were imaged without any procedural complications. The nominal stent length was 28 ± 4.5 mm. OCT was the most accurate technique for assessing stent length (28.12 ± 6.8 mm), while QCA underestimated length due to foreshortening (22.16 ± 6.39 mm) and IVUS was vulnerable to random error due to discontinuous pullbacks and vessel movements (24.21 ± 7.90 mm). Minimum lumen area (MLA) and minimum lumen diameter (MLD) in reference sites were comparable in IVUS and OCT, whereas there were significant differences between these two modalities for MLA (3.30 ± 1.49 vs. 2.19 ± 1.30 mm², p = 0.0046) and for MLD (2.42 ± 0.51 vs. 1.58 ± 0.56 mm², p = 0.0023) in stented segments. There was a slight overestimation of lumen volume (130.18 ± 70.61 vs. 117.82 ± 67.02 mm³, p = 0.7256),a marked overestimation of stent volume (179.29 ± 97.58 vs. 226.46 ± 108.76 mm³, p = 0.0544) and a statistically significant difference in the neointima volume (49.11 ± 39.70 vs. 108.64 ± 43.77 mm³, p = 0.0060) by IVUS compared to OCT. Mean neointima burden in IVUS was much smaller than in OCT (20.79 ± 14.27% vs. 58.16 ± 18.25%, p = 0.0033). CONCLUSIONS OCT can precisely quantify struts coverage and is more accurate than IVUS in the assessment of vascular healing in patients after stent implantation.