Bartosz Rymuza

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.

Outcome prediction following transcatheter aortic valve implantation: Multiple risk scores comparison.

BACKGROUND The aim of the study was to compare 7 available risk models in the prediction of 30-day mortality following transcatheter aortic valve implantation (TAVI). Heart team decision supported by different risk score calculations is advisable to estimate the individual procedural risk before TAVI. METHODS One hundred and fifty-six consecutive patients (n = 156, 48% female, mean age 80.03 ± 8.18 years) who underwent TAVI between March 2010 and October 2014 were in-cluded in the study. Thirty-day follow-up was performed and available in each patient. Base-line risk was calculated according to EuroSCORE I, EuroSCORE II, STS, ACEF, Amblers, OBSERVANT and SURTAVI scores. RESULTS In receiver operating characteristics analysis, neither of the investigated scales was able to distinguish between patients with or without an endpoint with areas under the curve (AUC) not exceeding 0.6, as follows: EuroSCORE I, AUC 0.55; 95% confidence intervals (CI) 0.47-0.63, p = 0.59; EuroSCORE II, AUC 0.59; 95% CI 0.51-0.67, p = 0.23; STS, AUC 0.55; 95% CI 0.47-0.63, p = 0.52; ACEF, AUC 0.54; 95% CI 0.46-0.62, p = 0.69; Amblers, AUC 0.54; 95% CI 0.46-0.62, p = 0.70; OBSERVANT, AUC 0.597; 95% CI 0.52-0.67, p = 0.21; SURTAVI, AUC 0.535; 95% CI 0.45-0.62, p = 0.65. SURTAVI model was calibrated best in high-risk patients showing coherence between expected and observed mortality (10.8% vs. 9.4%, p = 0.982). ACEF demonstrated best classification accuracy (17.5% vs. 6.9%, p = 0.053, observed mortality in high vs. non-high-risk cohort, respectively). CONCLUSIONS None of the investigated risk scales proved to be optimal in predicting 30-day mortality in unselected, real-life population with aortic stenosis referred to TAVI. This data supports primary role of heart team in decision process of selecting patients for TAVI.

Direct transcatheter aortic valve implantation – one-year outcome of a case control study

Introduction Transaortic valve implantation (TAVI) has a well-established position in the treatment of high-risk and inoperable patients with severe aortic stenosis (AS). The TAVI protocol requires a pre-dilatation for native valve preparation. Aim To assess the safety and feasibility of TAVI without pre-dilatation and to compare it with the procedure with pre-dilatation. Material and methods Out of 101 TAVI patients, in 10 the procedure was performed without balloon predilatation, and 8 patients were included in the analysis. The procedural, echocardiographic, and clinical outcomes were compared with a case control matched cohort (1: 2 ratio). A 12-month follow-up was done in all cases. Results The procedure was successfully completed in all patients in the study group (SG), but there was one procedural failure in the control group (CG). All patients received a CoreValve (Medtronic) bioprosthesis. There was a significant immediate decrease in transvalvular gradients (TG) in both study arms after the procedure (SG: mean TG: from 46.0 ±14.0 mm Hg to 10.0 ±4.8 mm Hg, p < 0.001; CG: mean TG: from 55.9 ±12.0 mm Hg to 9.9 ±2.9 mm Hg, p < 0.001). A marked increase in the effective orifice areas was observed in both cohorts (SG: 1.63 ±0.13 cm2 and CG: 1.67 ±0.25 cm2, p = 0.75). The periprocedural complication rate was equally distributed in both arms. The 12-month all-cause mortality was 12.5% in both groups. Conclusions The direct TAVI approach seams to be safe and feasible. The clinical and echocardiographic results are not different from those achieved in patients treated with standard TAVI protocol with pre-dilatation.

Common carotid artery access for transcatheter aortic valve implantation

Transcatheter aortic valve implantation (TAVI) is an alternative method of treatment for severe symptomatic aortic stenosis in patients who are at high risk of surgical aortic valve replacement (AVR). In randomised clinical trials TAVI was shown to be superior to standard medical therapy in a cohort of inoperable patients and non-inferior to AVR in high-risk operable patients. Additionally, in a recent trial with self-expandable prosthesis use, TAVI was associated with lower mortality compared with surgery. Usually, femoral arteries are the most common vascular access to deliver the bioprosthesis; however, in some cases (up to 20%) this route may not be applied because of significant peripheral artery disease or tortuosity. In this article, we present the first two TAVI procedures in Poland performed via the left common carotid artery.

Transcatheter aortic valve replacement in bicuspid aortic valve disease.

Purpose of review Bicuspid aortic valve stenosis is regarded as a relative contraindication for transcatheter aortic valve replacement (TAVR) according to current guidelines, as patients with bicuspid anatomy (BiAV) were excluded from landmark clinical trials. In this review, we will discuss the feasibilty, safety and outcomes of TAVR in BiAV, based upon the current literature and our own experience. Recent findings The currently available data come from observational registries with low sample size, and only in a few were the results of TAVR in BiAV compared with those achieved in the cohort with tricuspid anatomy. TAVR proved to be technically feasible in selected BiAV patients, and the mid-term clinical outcomes are acceptable. Nevertheless, there are still some unresolved issues, such as long-term valve durability and the relatively high rate of paravalvular leakage. Summary The existing literature supports the use of TAVR in selected high-risk BiAV patients, although the final role of this technique in this cohort of patients can only be established once a larger, preferably randomized, study comparing TAVR with surgery is performed.

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.

Platelet distribution width predicts left ventricular dysfunction in patients with acute coronary syndromes treated with percutaneous coronary intervention.

BACKGROUND The role of platelets in the pathophysiology of acute coronary syndromes (ACS) is undeniable, but precise relationships between platelet activity and treatment outcomes are a matter of continuant investigation. Among platelet indices, mean platelet volume (MPV) has proven to be a valuable predicting factor in cardiac patients. However, platelet distribution width (PDW) is reported to be a more specific marker of platelet reactivity. Thus, application of PDW in risk stratification of ACS treatment is an up-to-date subject of research. PDW values in the assessment of left ventricular (LV) function have not been previously studied. AIM The aim of the study was to evaluate whether admission PDW can predict LV systolic function in patients with ACS treated with stent implantation. METHODS On-admission PDW was measured in 278 consecutive patients with diagnosis of ACS, who underwent stent(s) implantation. Echocardiogram with LV ejection fraction (LVEF) estimation was performed within 24 h of percutaneous coronary intervention. Additionally, patients were under one-year follow-up, and one-year all-cause mortality was assessed. RESULTS According to receiver-operating characteristics (ROC) analysis, a PDW value greater than 12.8 fL could predict LVEF ≤ 35% with sensitivity of 81% and specificity of 39% (AUC 0.614; p = 0.0177). Only a trend was noted in ROC for PDW and one-year mortality (AUC 0.608; p = 0.0815). Multivariate logistic regression analysis has shown that the PDW parameter correlates independently with both systolic heart failure with LVEF ≤ 35% (PDW cut-off: 12.8 fL, OR 2.8107, CI 1.1401-6.9293, p = 0.0248) and one-year mortality (PDW cut-off: 16 fL, OR 2.6750, CI 1.0190-7.0225, p = 0.0457). CONCLUSIONS Admission PDW may serve as a simple and widely available predictor of impaired LV function in patients with ACS. Association between PDW and mortality needs to be confirmed in larger studies.

Transcatheter aortic valve implantation (TAVI) in a patient with severe aortic insufficiency of aortic valve homograft

We present the case of a 64-year-old female who was admitted to our centre with severe aortic insufficiency and advanced heart failure symptoms (NYHA class III–IV). Her medical history included: surgical homograft aortic valve replacement due to severe aortic insufficiency 14 years ago, chronic atrial fibrillation, and hypothyroidism. The patient’s logistic EuroSCORE was 32%, EuroSCORE II 9.1%, and STS score 3.95%. Preprocedural transthoracic echocardiographic examination revealed akinesis of the basal and mid segments of interventricular septum, global hypokinesis of remaining segments with ejection fraction of 19%, enlargement of the left ventricle and atrium (diameter of 68 and 43 mm, respectively), regurgitant orifice area of 0.3 cm2, regurgitant volume of 58 mL, and regurgitant jet width to left ventricular outflow tract ratio of 66% (Fig. 1). An additional transoesophageal echocardiographic examination was performed for more precise measurement: this showed aortic annulus diameter of 24 mm. Angiography and computed tomography were also performed, showing no lesions in either the coronary or peripheral arteries. On the basis of the abovementioned clinical conditions, the Heart Team decided to refer the patient to transcatheter aortic valve implantation (TAVI) via femoral access. The procedure was performed under general anaesthesia with a temporary pacemaker placed through the jugular vein and vascular access obtained with 18 Fr sheath by puncture of the right femoral artery. Due to lack of calcifications, two pig-tail catheters were placed in order to mark the plane of the annulus (Fig. 2) and 29 mm Medtronic CoreValveTM bioprosthesis was implanted under rapid pacing. Despite these preventive measures, the final position of prosthesis was too low with moderate-to-severe aortic insufficiency (Fig. 3) that persisted even after postdilatation with a 28 mm balloon. Therefore, the decision to implant another 29 mm CoreValve 10 to 15 mm higher was made. Finally, in control imaging, only a mild paravalvular leak was present (Fig. 4), and on discharge the ejection fraction had improved to 43%. TAVI is an effective treatment option for severe aortic stenosis in inoperable and high-risk patients. However, failure (mostly insufficiency) of a previous homograft aortic valve poses a challenge for any interventional treatment. In selected patients, TAVI can be a feasible alternative for high risk re-operation. TAVI may also be considered in some cases of native aortic insufficiency where there is favourable anatomy.

Holographic imaging during transcatheter aortic valve implantation procedure in bicuspid aortic valve stenosis

We present a case of an 80-year-old male patient with symptomatic aortic stenosis, admitted to the 1st Department of Cardiology, Medical University of Warsaw for valve replacement. His prior medical history included: non-obstructive coronary artery disease, transurethral prostatectomy, right-sided hernia, and right-sided nephrolithiasis surgery. Transthoracic echocardiography showed mean aortic pressure gradient of 40 mm Hg, aortic valve area (AVA) of 0.77 cm2, and peak velocity of 4.3 m/s. For precise aortic annulus measurement, transoesophageal echocardiography (TEE) and a multi-sliced computed tomography (MSCT; Fig. 1) scan were performed. On TEE the aortic annulus perimeter was 83 mm, with diameters 24 × 29 mm. On MSCT annulus perimeter was 87 mm with diameters of 23 × 32 mm. Both imaging techniques revealed that the patient had bicuspid aortic valve with raphe between left and right coronary cusps (Type I L-R) and protruding calcium to the left ventricular outflow tract. The “prospected” annulus perimeter based on MSCT was 79.3 mm. The patient was referred by the local Heart Team to transcatheter aortic valve implantation (TAVI) via the femoral route. To better visualise the complex anatomy of the patient with bicuspid AS the use of holographic imaging was applied. CarnaLife Holo® (MedApp S.A., Krakow, Poland) visualises the individual patient’s heart as an interactive holographic image based on computed tomography (CT) or a magnetic resonance imaging (MRI) scan of the patient (Fig. 2A–C). Possible interactions using voice commands and hand gestures include visualising the structure of the heart (3D), also during its cardiac cycle (4D), slicing, and partitioning. Users see and interact with those images via a Microsoft HoloLens® head-mounted display (Fig. 2D), which creates the visual illusion of a solid 3D object by recreating depth cues (perspective, occlusion, convergence, and parallax). The software supports loading of the medical data sets in common DICOM file format and adjusting the transfer function to achieve effective visualisation of skin, hard tissues like bones, and soft tissue organs like heart, based on methods well-established in the medical visualisation field. This method allows for the use of raw medical data acquired from CT and MRI devices, in contrast to the common approach with additional surface reconstruction to polygonal models, as in the case of typical surgery approaches with head-mounted displays. The periprocedural use of CarnaLife Holo® enabled the operator to view holographic image during the course of the procedure, facilitating precise visualisation of the aortic root. Ultimately the patient was implanted with a 29-mm Evolut R (Medtronic Int.) valve with small paravalvular leak (AVA 1.74 cm2, mean pressure gradient 9 mm Hg, Vmax 2.4 m/s) and no conduction disturbances. The patient was discharged home on day 2 after the procedure in good clinical condition. Figure 1. Multi-sliced computed tomography (MSCT) curved three-dimensional multiplanar reconstruction (3D MPR); A. Cross-section of the aortic valve at the level of the sinus of Valsalva showing bicuspid anatomy with raphe between left and right coronary cusps; B. Preprocedural 3D MPR maximal intensity projection (MIP) showing heavily calcified aortic valve with calcification extending into the left ventricular outflow tract; C. Post-procedural 3D MPR MIP with correct apposition of implanted bioprosthesis

Successful percutaneous coronary intervention after transcatheter aortic valve implantation with CoreValve bioprosthesis

We present a case of an 84-year-old male patient who was admitted to our department due to recurrent angina 17 months after transcatheter aortic valve implantation (TAVI) with a 29 mm CoreValve bioprosthesis (Figure 1). Symptoms were increasing in the past several weeks, and on admission the patient was in Canadian Cardiovascular Society class 3. His past medical history included hypertension and chronic atrial fibrillation. Non-invasive diagnostics was initially started with trans-thoracic echocardiography, which did not show signs of left ventricle wall motion abnormalities. Secondly, single-photon emission computed tomography (SPECT) was performed, showing a significant perfusion drop in the left ventricle anterior wall after dipyridamole administration. The patient was referred for coronary angiography. During the examination a critical ostial lesion of the left anterior descending (LAD) artery was discovered with impaired myocardial flow to the distal portion of the artery (TIMI 2). On examination performed 2 months prior to TAVI there were no significant lesions in coronary arteries. Percutaneous intervention (PCI) started with the positioning of a 6 Fr EBU 3.5 catheter between aortic bioprosthesis struts and into the ostium of the left coronary artery (LCA). Afterwards standard PCI with stent implantation was performed. Percutaneous coronary intervention result was good with no significant residual stenosis and restored normal TIMI flow. At discharge, triple antithrombotic therapy was recommended (aspirin, clopidogrel, vitamin K antagonist (VKA)) for 1 month, which should be followed by dual therapy for up to 1 year (aspirin/clopidogrel, VKA). Even though the nitinol frame of the CoreValve bioprosthesis extends to the ascending aorta, the space between the struts is wide enough to ensure coronary access. Navigating through the struts may be burdened with additional difficulties depending on the bioprosthesis final position in relation to the coronary ostia, which may be hidden behind the frame struts or behind the parts of the leaflets sewn to the nitinol frame. Crossing through the gaps may not be necessary when it comes to diagnostic angiography. In some cases sub-selective contrast injection may fully visualize the coronary sinus and coronary arteries, and may be helpful when struts are crossing the coronary ostia. In terms of TAVI, PCI performed prior to the valve implantation is believed to be gold standard, yet the optimal timing of PCI relative to TAVI is still uncertain and is the subject of constant discussion regardless of growing experience. However, due to improvement of long-term TAVI outcomes, increase of frequency of post-TAVI PCI dictated by the progression of coronary artery disease (CAD) is expected. The above-mentioned procedure is achievable, but may prove demanding – especially when valve prostheses’ elements/struts are in the close vicinity of the coronary ostia, making it difficult to gain optimal support. Different types of new generation bioprosthesis may have valve-specific crossing and support issues, which make intervention more challenging. Further investigations are necessary to assess the safety of post-TAVI PCI and to develop the best solutions for different patients [1–4]. Figure 1 Steps of the procedure: coronary angiography showing critical lesion in the proximal LAD (A); catheter placement and wire crossing (B); stent implantation (C); final result (D); *possibile locations of the coronary ostia (RCA – NCC); – ...