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.

Baseline platelet indices and bleeding after transcatheter aortic valve implantation.

Bleeding complications are frequent and independently predict mortality after transcatheter aortic valve implantation (TAVI). It has been demonstrated that certain platelet parameters are indicative of platelet reactivity. We sought to determine the possible correlation between simple platelet indices and bleeding complications in patients undergoing TAVI. Platelet indices--platelet count, mean platelet volume (MPV), platelet distribution width and plateletcrit--were measured in 110 consecutive patients on the day preceding TAVI. In-hospital bleeding events after TAVI were assessed according to the Valve Academic Research Consortium-2 classification as any bleeding, major and life-threatening bleeding (MLTB) and need for transfusion. By receiver-operating characteristic analysis, only MPV was able to distinguish between patients with and without any bleeding [area under the curve (AUC) 0.629, 95% confidence interval (CI) 0.531-0.719, P = 0.0342], MLTB (AUC 0.730, 95% CI 0.637-0.811, P = 0.0004) and need for transfusion (AUC 0.660, 95% CI 0.563-0.747, P = 0.0045). By multivariate logistic regression, high MPV (>10.6) and low platelet distribution width (<14.8) were associated with increased risk of any bleeding [odds ratio (OR) 4.08, 95% CI 1.66-10.07, P = 0.0022; and OR 3.82, 95% CI 1.41-10.36, P = 0.0084, respectively] and MLTB (OR 10.76, 95% CI 3.05-38, P = 0.0002; and OR 8.46, 95% CI 1.69-42.17, P = 0.0092, respectively). Additionally, high MPV independently correlated with the need for transfusion (OR 4.11, 95% CI 1.71-9.86, P = 0.0016). Larger and less heterogenic platelets may be associated with increased risk of short-term bleeding complications after TAVI.

Comparison of one- and 12-month outcomes of transcatheter aortic valve replacement in patients with severely stenotic bicuspid versus tricuspid aortic valves (results from a multicenter registry).

The aim of the study was to evaluate the transcatheter aortic valve replacement (TAVR) in high-risk patients with severe bicuspid aortic valve (BAV) stenosis and to compare the outcomes with a matched group of patients with tricuspid aortic valve. TAVR became an alternative treatment method in high-risk patients with symptomatic aortic stenosis; however, BAV stenosis is regarded as a relative contraindication to TAVR. The study population comprised 28 patients with BAV who underwent TAVR. BAV was diagnosed based on a transesophageal echocardiography. CoreValve and Edwards SAPIEN prostheses were implanted. The control group consisted of 84 patients (3:1 matching) with significant tricuspid aortic valve stenosis treated with TAVR. There were no significant differences between patients with and without BAV in device success (93% vs 93%, p = 1.0), risk of annulus rupture (0% in both groups), or conversion to cardiosurgery (4% vs 0%, respectively, p = 0.25). The postprocedural mean pressure gradient (11.5 ± 6.4 vs 10.4 ± 4.5 mm Hg, p = 0.33), aortic regurgitation grade ≥2 of 4 (32% vs 23%, p = 0.45), 30-day mortality (4% vs 7%, p = 0.68), and 1-year all-cause mortality (19% vs 18%, p = 1.00) did not differ between the groups. Echocardiography showed well-functioning valve prosthesis with a mean prosthetic valve area of 1.6 ± 0.4 cm(2) versus 1.7 ± 0.3 cm(2) (p = 0.73), a mean pressure gradient of 10.3 ± 5.4 versus 9.8 ± 2.8 mm Hg (p = 0.64), and aortic regurgitation grade ≥2 of 4 (22% vs 22%, p = 1.00) for the 2 groups. In conclusion, selected high-risk patients with BAV can be successfully treated with TAVR, and their outcomes are similar to those reported in patients without BAV.

Quality of life in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention--radial versus femoral access (from the OCEAN RACE Trial).

Numerous studies have compared transradial (TR) versus transfemoral (TF) access for percutaneous coronary intervention (PCI) in patients with acute ST-segment elevation myocardial infarction. These studies have focused on clinical efficacy and safety; yet little is known about the effect of the vessel access on the health-related quality of life (HRQoL). In the present study, patients were randomly assigned to TR (n = 52) or TF (n = 51) access groups. Generic (EQ-5D-3L) and cardiac-specific (Quality of Life Index and MacNew) tools were used to assess HRQoL before PCI and 2 hours and 4 days after PCI. Baseline HRQoL was comparable in both groups and improved after PCI. The mean ± SD EQ-5D-3L health utility score 2 hours after PCI was 0.46 ± 0.291 and was higher in the TR group (TR: 0.60 ± 0.299 versus TF: 0.32 ± 0.283, p <0.001). Patients in the TR group reported fewer problems with mobility (TR: 71.7% vs TF: 94.4%, p <0.01) and self-care (TR: 62.5% vs TF: 97.2%, p <0.001). At day 4, fewer patients reported problems with anxiety and/or depression in the TR group than in the TF group (TR: 42.9% vs TF: 75.0%, p <0.001); no differences between groups in other measures were observed (Quality of Life Index and MacNew). The N-terminal of the prohormone brain natriuretic peptide levels were inversely correlated with EQ-5D-3L visual analog scale (r = -0.348, p <0.05) and EQ-5D-3L health utility score (r = -0.322, p <0.05). There was a correlation between in-hospital mortality and 2 MacNew domains: physical (r = -0.329, p <0.05) and emotional (r = -0.374, p <0.01). In conclusion, radial access should be the preferred approach in patients with ST-segment elevation myocardial infarction undergoing PCI when considering HRQoL. Radial access is associated with fewer problems with mobility and self-care and better psychological outcome after PCI.

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.

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.

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.

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.

[Assessment of the susceptibility of the gram-negative rods isolated from hospitalized patients to cefoperazone/sulbactam]. / Ocena wrazliwosci na cefoperazon/sulbaktam szczepów paleczek gram-ujemnych izolowanych od chorych hospitalizowanych.

The susceptibility to cefoperazone/sulbactam of 197 strains of Gram-negative rods demonstrating an ESBL-positive phenotype was determined. The assortment of the investigated strains was as follows (numbers of strains are given in the brackets): E. cloacae (63), S. marcescens (46), K. pneumoniae (21), P. mirabilis (17), E. coli (9), P. vulgaris (8), P. aeruginosa (20) and A. baumanni (13). 83 strains from 197 were susceptible (42.1%). The MIC values were determined and the disc-diffusion method was performed. The susceptibilities among particular species were as follows (the order of data in the brackets is: % of the susceptible strains/MIC50/MIC90): E. cloacae (54.0/16/64), S. marcescens (23.9/64/> or = 128), K. pneumoniae (38.1/32/64), P. mirabilis (41.2/32/64), E. coli (44.4/32/32), P. vulgaris (75.0/8/32), P. aeruginosa (35.0/32/64), A. baumannii (46.2/32/64). Using disc-diffusion method, for 184 strains the difference between diameter of the inhibition zone around the disc with cefoperazone and the disc with cefoperazone/sulbactam was calculated. This difference amounted 5 mm or more in the case of 76.6% of the investigated strains. The results indicate that the comparison of the inhibition zones around cefoperazone and cefoperazone/sulbactam discs may be an additional method useful for phenotypic detection of ESBL producing organisms. These results highly correlated with results obtained by using analogous test with cefpirome and cefpirome/clavulanic acid (85.6% of concordance).