Tomasz Tokarek

Assessment of quality of life in patients after surgical and transcatheter aortic valve replacement.

Transcatheter aortic valve implantation (TAVI) and minimally invasive aortic valve replacement (mini‐thoracotomy, mini‐sternotomy, MIAVR) have become an appealing alternative to conventional surgical (SAVR) treatment of severe aortic stenosis (AS) in high‐risk patients.

Twelve months clinical outcome after bioresorbable vascular scaffold implantation in patients with stable angina and acute coronary syndrome. Data from the Polish National Registry

Introduction There are limited data describing bioresorbable vascular scaffold (BVS) implantation in complex lesions. Only short-term clinical outcomes are available for patients with acute coronary syndrome (ACS). Aim To evaluate 12-month clinical outcome, safety and effectiveness of BVS implantation in complex lesions and in stable angina (SA) or ACS. Material and methods Five hundred ninety-one patients with SA/ACS were enrolled between October 2012 and November 2013 in 30 invasive cardiology centres in Poland. At least one BVS implantation during percutaneous coronary intervention (PCI) was the only inclusion criteria. The clinical endpoint was the occurrence of a major adverse cardiovascular event (MACE) (all-cause death, myocardial infarction (MI), clinically driven target lesion revascularisation (TLR) with urgent PCI or target vessel revascularisation (TVR) with urgent coronary artery bypass grafting (CABG)) and device-oriented composite endpoint (DOCE) (cardiac death, urgent target vessel revascularisation with PCI/CABG, target vessel MI) during 12-month follow-up. Results After 12 months TLR with urgent PCI was significantly more often reported in patients with diagnosed UA (4.59%; p < 0.02) in comparison with other PCI indications. No significant differences were found in terms of composite MACE endpoint, cumulative MACE (p = 0.09), stent thrombosis (p = 0.2) or restenosis (p = 0.2). There were no significant differences in cumulative MACE and composite MACE endpoint between patients with no/mild versus moderate/severe tortuosity and no/mild versus moderate/severe calcification of the target vessel. No significant difference was found between groups of patients with or without bifurcation of the target vessel. Device-oriented composite endpoint was significantly more often reported in the ACS group (3.2% vs. 0.47%; p < 0.03), most frequently in patients with diagnosed UA (5.5%). Conclusions Bioresorbable vascular scaffold can be successfully and safely used for ACS treatment and in lesions of higher complexity.

Borderline trend towards long-term mortality benefit from drug eluting stents implantation in ST-elevation myocardial infarction patients in Poland-data from NRDES registry.

To analyze long‐term outcome of ST‐Elevation Myocardial Infarction (STEMI) and non‐STEMI (NSTEMI) patients treated with Drug Eluting Stents (DES) stents with regard to mortality and stent thrombosis rates based on the national Polish PCI registry database.

Usefulness of Psoas Muscle Area and Volume and Frailty Scoring to Predict Outcomes After Transcatheter Aortic Valve Implantation

Numerous scales were implemented for frailty assessment. However, limited evidence and recommendations for frailty tools for everyday clinical practice in patients who underwent transcatheter aortic valve implantation (TAVI) exist. Thus, we aimed to determine the long-term predictive value of different frailty scores and objective assessment of sarcopenia by imaging techniques in patients after TAVI. Frailty indexes according to Valve Academic Research Consortium-2 (VARC-2) recommendations, as well as other available scales of frailty, were assessed at baseline. Sarcopenia was evaluated with psoas muscle area (PSA) and psoas muscle volume (PSV) using computed tomography (CT) scans. The primary end point was 12-month all-cause mortality. We enrolled 153 patients who underwent TAVI with analyzable CT scans and complete frailty data. The median of PSA normalized for body surface area was 2,581.1 (2,214.9 to 2,654.9) mm2/m2, and the median of normalized PSV was 338.8 (288.1-365.6) cc/m2. At 12 months, all-cause mortality and new-onset atrial fibrillation were highest in the lowest tertile of normalized PSA. In the receiver operating characteristic analysis, all the tested frailty indexes, as well as PSA and PSV, were good predictors of 12-month all-cause mortality after TAVI with the highest area under the curve value for PSA and PSV normalized for body surface area. In conclusion, normalized PSA and PSV values are strong predictors of long-term mortality after TAVI. CT evaluation of psoas muscles could be incorporated to preprocedural comprehensive clinical models used for prediction of outcomes in patients scheduled for TAVI.

Patient profile and periprocedural outcomes of bioresorbable vascular scaffold implantation in comparison with drug-eluting and bare-metal stent implantation. Experience from ORPKI Polish National Registry 2014–2015

Introduction There are limited data on the comparison of bioresorbable vascular scaffold (BVS) and drug-eluting stent (DES)/bare-metal stent (BMS) implantation in an unselected population of patients with coronary artery disease. Aim To compare the periprocedural outcomes and patient profile of BVS and DES/BMS implantation in an all-comer population from the ORPKI Polish National Registry. Material and methods A total of 141,324 consecutive patients from 151 invasive cardiology centers in Poland were included in this prospective registry between January 2014 and June 2015. Periprocedural data on patients with at least one BVS (Absorb, Abbott Vascular, Santa Clara, CA, USA), DES or BMS (all available types) implantation in de novo lesions during index percutaneous coronary intervention for stable angina (SA) or acute coronary syndrome were collected. Results Bioresorbable vascular scaffold was the most often used in patients with SA, in single-vessel disease and in younger male patients. Bioresorbable vascular scaffold implantation was significantly more often associated with periprocedural administration of ticagrelor/prasugrel (6.8% vs. 3.6%; p = 0.001) and use of intravascular ultrasound and optical coherence tomography in comparison with the DES/BMS group (2.8% vs. 0.6% and 1.8% vs. 0.1%, respectively; p = 0.001 for both). The incidence of periprocedural death was significantly lower in the BVS group than the DES/BMS group (0.04% vs. 0.32%; p = 0.02), but this difference was no longer significant after adjustment for covariates. On the other hand, coronary artery perforation occurred significantly more often during BVS delivery (0.31% vs. 0.12%; p = 0.01), and BVS implantation was identified as an independent predictor of coronary artery perforation in multivariate logistic regression analysis (OR = 6.728, 95% CI: 2.394–18.906; p = 0.001). Conclusions Patients treated with BVS implantation presented an acceptable safety and efficacy profile in comparison with the DES/BMS group. However, lower risk patients were the most frequent candidates for BVS implantation.

The network of invasive cardiology facilities in Poland in 2016 (data from the ORPKI Polish National Registry)

INTRODUCTION Despite significant advancements in cardiac care, cardiovascular diseases (CVDs) are the main cause of mortality in Poland. Thus, they should be a priority in the national health policy. In addition, further optimisation of medical care requires maintenance of an effective, integrated, and networked structure of the treatment of CVDs. In Poland, treatment of coronary artery disease, including acute coronary syndrome (ACS), is currently provided complimentarily by a network of highand low-volume percutaneous coronary intervention (PCI) centres. Importantly, the network has been organised and developed by Polish cardiologists for almost 20 years. During that period, multiple strategies have been introduced to improve the safety and efficacy of national care for patients with ACS. These have included a reduction of the time from first medical contact to reperfusion through an increase in the availability of primary-PCI centres, direct transfer, bypassing non-PCI-capable hospitals or emergency departments, and early cath lab activation after electrocardiogram teletransmission from the field [1–5]. Despite this, approximately 50% of patients with ST-segment elevation myocardial infarction (STEMI) are still not transferred directly to the appropriate facility and may experience an unnecessary delay to reperfusion [3, 4]. Thus, regional and countrywide systems of care face an ongoing challenge of determining the best policies for geographical distribution of cath labs and time frames of transferring the patients from referring centres to primary-PCI hospitals. Data on the current activity and geographical distribution of cath labs may be helpful to refine the network. Thus, we sought to evaluate the current number, performance, and localisation of PCI facilities in Poland, based on data from the Polish National PCI Registry (ORPKI). METHODS The ORPKI Registry is operated by the Jagiellonian University Medical College in Krakow, Poland (https://www.orpki.cm-uj. krakow.pl/) and is endorsed by the Polish Association of Cardiovascular Interventions of the Polish Cardiac Society (AISN PTK) [6]. The registration in the ORPKI database is voluntary; however, as much as 98% of all catheterisation laboratories in Poland have joined the registry. For this study, complete data for 2016 collected from 157 cath labs were extracted. The centres were divided into high-volume (≥ 400 PCIs/year) and low-volume (< 400 PCIs/year), depending on the total number of all PCIs performed in a particular cath lab in 2016. A cut-off value of 400 PCIs/year was selected, as recommended by the European Society of Cardiology (ESC) guidelines on myocardial revascularisation [6]. In addition, data from the highest-volume centres, according to a cut-off value of 1000 PCIs/year, were assessed. Subsequently, data concerning numbers of PCIs were stratified by the initial diagnosis.

Sex-related differences in clinical outcomes and quality of life after transcatheter aortic valve implantation for severe aortic stenosis

Introduction There are inconsistent data on the sex-related differences in clinical outcomes and quality of life (QoL) after transcatheter aortic valve implantation (TAVI). Aim We sought to investigate sex-related differences in procedural, clinical and QoL outcomes of TAVI. Material and methods A total of 101 consecutive patients undergoing TAVI were enrolled. Patients were stratified by gender. Baseline characteristics, procedural and long-term clinical outcomes as well as frailty and QoL indices (EQ-5D-3L questionnaire) were compared between women and men. Results Women represented 60.4% of the study population. Periprocedural risk measured with the Logistic EuroSCORE and STS scale was similar for women and men. There were no differences in 30-day or 12-month all-cause mortality between groups (women vs. men: 9.8% vs. 12.5%; age-adjusted odds ratio (OR) (95% CI): 1.38 (0.39–4.94); 13.1% vs. 25.0%; age-adjusted OR (95% CI): 2.51 (0.87–7.25)). Men were at higher risk of new onset atrial fibrillation at follow-up (1.6% vs. 17.5%; age-adjusted OR (95% CI): 14.61 (1.68–127.37)). In multivariable Cox regression analysis, a history of stroke/transient ischemic attack (TIA) (hazard ratio (HR)) (95% CI): 3.93 (1.39–11.07) and blood transfusion (HR (95% CI): 2.84 (1.06–7.63)) were identified as independent factors affecting 12-month mortality. No differences in QoL parameters were noted. Conclusions The TAVI can be considered as an effective and safe treatment in high-risk patients with severe aortic stenosis, regardless of gender.

Long-term quality of life and clinical outcomes in patients with resistant hypertension treated with renal denervation

Introduction Pharmacological treatment combined with lifestyle modifications is an effective treatment for arterial hypertension. However, there are still patients who do not respond to standard treatments. Patients with pharmacologically resistant hypertension may benefit from renal denervation (RDN). Aim To assess long-term quality of life (QoL) after RDN and effectiveness in reduction of blood pressure (BP) in patients with resistant hypertension. Material and methods From 2011 to 2014, 12 patients with previously diagnosed resistant hypertension, treated by RDN, were included in this study. The QoL was assessed using a standardized Polish version of the Nottingham Health Profile questionnaire (NHP). Results The median age was 54 (IQR: 51–57.5) years. Mean baseline ambulatory pre-procedural systolic/diastolic BP was 188/115 ±29.7/18 mm Hg. The mean values of systolic/diastolic BP measured perioperatively and 3, 6, 12 and 24 months postoperatively were 138/86, 138/85, 146/82, 152/86, and 157/91. All p-values for mean systolic and diastolic BP before versus successive time points after RDN were statistically significant; p-value for all comparisons < 0.05. Improvement of QoL was only observed in two sections of the NHP questionnaire: emotional reaction and sleep disturbance. The analysis of the NHP index of Distress (NHP-D) showed a lower distress level perioperatively and 3, 6, 12 and 24 months after RDN as compared to baseline. The RDN was not associated with any significant adverse events. Conclusions Patients with pharmacologically resistant hypertension treated with RDN achieved significant reduction in BP during 24-month follow-up. Furthermore, a significant improvement in the QoL was observed in those patients.

Comparison of radiation dose exposure in patients undergoing percutaneous coronary intervention vs. peripheral intervention

Introduction Most endovascular techniques are associated with patient and personal exposure to radiation during the procedure. Ionising radiation can cause deterministic effects, such as skin injury, as well as stochastic effects, which increase the long-term risk of malignancy. Endovascular operators need to be aware of radiation danger and take all necessary steps to minimise the risk to patients and staff. Some procedures, especially percutaneous peripheral artery revascularisation, are associated with increased radiation dose due to time-consuming operations. There is limited data comparing radiation dose during percutaneous coronary intervention (PCI) with percutaneous transluminal angioplasty (PTA) of peripheral arteries. Aim To compare the radiation dose in percutaneous coronary vs. peripheral interventions in one centre with a uniform system of protection methods. Material and methods A total of 352 patients were included in the study. This included 217 patients undergoing PCI (single and multiple stenting) and 135 patients undergoing PTA (in lower extremities, carotid artery, renal artery, and subclavian artery). Radiation dose, fluoroscopy time, and total procedural time were reviewed. Cumulative radiation dose was measured in gray (Gy) units. Results The total procedural time was significantly higher in PTA (PCI vs. PTA: 60 (45–85) min vs. 75 (50–100) min), p < 0.001. The radiation dose for PCI procedures was significantly higher in comparison to PTA (PCI vs. PTA: 1.36 (0.83–2.23) Gy vs. 0.27 (0.13–0.46) Gy), p < 0.001. There was no significant difference in the fluoroscopy time (PCI vs. PTA: 12.9 (8.2–21.5) min vs. 14.4 (8.0–22.6) min), p = 0.6. The analysis of correlation between radiation dose and fluoroscopy time in PCI and PTA interventions separately shows a strong correlation in PCI group (r = 0.785). However, a weak correlation was found in PTA group (r = 0.317). Conclusions The radiation dose was significantly higher during PCI in comparison to PTA procedures despite comparable fluoroscopy time and longer total procedure time in PTA. Fluoroscopy time is a reliable parameter to control the radiation dose exposure in coronary procedures. The increasing complexity of endovascular interventions has resulted in the increase of radiation dose exposure during PCI procedures.

Impact of previous cardiac surgery with sternotomy on clinical outcomes and quality of life after transcatheter aortic valve implantation for severe aortic stenosis

BACKGROUND Transcatheter aortic valve implantation (TAVI) has evolved as an effective treatment in patients with symptomatic severe aortic stenosis (AS) and increased operative risk. Data on the influence of previous sternotomy on the risk of TAVI are limited. AIM We sought to investigate the effect of previous cardiac surgery with sternotomy on clinical outcomes and quality of life (QoL) after TAVI. METHODS The study included 148 consecutive patients with symptomatic severe AS, who underwent TAVI. Baseline charac-teristics, procedural and long-term clinical outcomes, and QoL assessment with the EQ-5D-3L questionnaire were compared between patients with and without previous sternotomy. RESULTS Patients with previous sternotomy (23.0% of the population) were younger and more often male, had higher rate of previous myocardial infarction (MI; 26 [22.8%] vs. 22 [64.7%], p = 0.001), and lower median left ventricular ejection frac-tion (60.0% [50.0-65.0] vs. 50.0% [42.0-60.0], p = 0.004). Periprocedural risk measured with the Logistic Euroscore and the Society of Thoracic Surgeons scale was comparable in both groups. There were no differences in 30-day and 12-month all-cause mortality between the groups with and without sternotomy (10 [8.8%] vs. 2 [5.9%], p = 0.7; odds ratio [OR] adjusted for age/sex/previous MI, 0.56, 95% confidence interval [CI] 0.10-3.29; for 12-month mortality adjusted OR 0.19, 95% CI 0.04-0.99). At the longest available follow-up, mortality was higher in patients without sternotomy (30 [26.3%] vs. 3 [8.8%], p = 0.03; adjusted OR 0.10, 95% CI 0.02-0.42). Similar rates of other complications after TAVI were noted. No differences in the EQ-5D-3L questionnaire at baseline and 12-month follow-up were confirmed. CONCLUSIONS TAVI seems to be a safe and effective technique for the treatment of severe AS in patients with previous cardiac surgery.