Oral anticoagulation therapy in atrial fibrillation patients at high risk of bleeding: Clinical characteristics and treatment strategies based on data from the Polish multicenter register of atrial fibrillation (POL-AF).

BACKGROUND: Despite its benefits, oral anticoagulant (OAC) therapy in patients with atrial fibrillation (AF) is associated with hemorrhagic complications. AIMS: We aimed to evaluate clinical characteristics of AF patients at high risk of bleeding and the frequency of OAC use as well as identify factors that predict nonuse of OACs in these patients. METHODS: Consecutive AF patients hospitalized for urgent or planned reasons in cardiac centers were prospectively included in the registry in 2019. Patients with HAS-BLED ≥3 (high HAS-BLED group) were assumed to have a high risk of bleeding. RESULTS: Among 3598 patients enrolled in the study, 29.2% were at high risk of bleeding (44.7% female; median [Q1-Q3] age 72 [65-81], CHA2DS2-VASc score 5 [4-6], HAS-BLED 3 [3-4]). In this group, 14.5% of patients did not receive OACs, 68% received NOACs, and 17.5% VKAs. In multivariable analysis, the independent predictors of nonuse of oral OACs were as follows: creatinine level (odds ratio [OR], 1.441; 95% confidence interval [CI], 1.174-1.768; P <0.001), a history of gastrointestinal bleeding (OR, 2.918; 95% CI, 1.395-6.103; P = 0.004), malignant neoplasm (OR, 3.127; 95% CI, 1.332-7.343; P = 0.009), and a history of strokes or transient ischemic attacks (OR, 0.327; 95% CI, 0.166-0.642; P = 0.001). CONCLUSIONS: OACs were used much less frequently in the group with a high HAS-BLED score than in the group with a low score. Independent predictors of nonuse of OACs were creatinine levels, a history of gastrointestinal bleeding, and malignant neoplasms. A history of stroke or transient ischemic attack increased the chances of receiving therapy.

Comparison of safety and effectiveness between the right and left radial artery approach in percutaneous coronary intervention.

INTRODUCTION AND OBJECTIVES: There is a paucity of data comparing the left radial approach (LRA) and right radial approach (RRA) for percutaneous coronary intervention (PCI) in all-comers populations and performed by operators with different experience levels. Thus, we sought to compare the safety and clinical outcomes of the RRA and LRA during PCI in "real-world" patients with either stable angina or acute coronary syndrome (ACS). METHODS: To overcome the possible impact of the nonrandomized design, a propensity score was calculated to compare the 2 radial approaches. The study group comprised 18 716 matched pairs with stable angina and 46 241 with ACS treated with PCI and stent implantation between 2014 and 2017 in 151 tertiary invasive cardiology centers in Poland (the ORPKI Polish National Registry). RESULTS: The rates of death and periprocedural complications were similar for the RRA and LRA in stable angina patients. A higher radiation dose was observed with PCI via the LRA in both clinical presentations (stable angina: 1067.0±947.1 mGy vs 1007.4±983.5 mGy, P=.001; ACS: 1212.7±1005.5 mGy vs 1053.5±1029.7 mGy, P=.001). More contrast was used in LRA procedures but only in ACS patients (174.2±75.4mL vs 167.2±72.1mL, P=.001). Furthermore, periprocedural complications such as coronary artery dissection (0.16% vs 0.09%, P=.008), no-reflow phenomenon (0.65% vs 0.49%, P=.005), and puncture site bleeding (0.09% vs 0.05%, P=.04) were more frequently observed with the LRA in ACS patients. There was no difference in mortality between the 2 groups (P=.90). CONCLUSIONS: Our finding of poorer outcomes with the LRA may be related to lower operator experience with this approach. While both the LRA and RRA are safe in the setting of stable angina, the LRA was associated with a higher rate of periprocedural complications during PCI in ACS patients.

Why Did All Patients with Atrial Fibrillation and High Risk of Stroke Not Receive Oral Anticoagulants? Results of the Polish Atrial Fibrillation (POL-AF) Registry.

BACKGROUND: Most atrial fibrillation (AF) patients are at high risk of thromboembolic, and the use of oral anticoagulants (OACs) is advised in such cases. The aim of the study was to evaluate the frequency at which OACs were used in patients with AF and high risk thromboembolic complications, and identify factors that result in OACs not being used in the researched group of patients. METHODS: The prospective, multicenter and non-interventional POL-AF registry is a study that includes AF patients from ten Polish cardiology centers. They were consecutively hospitalized between January and December of 2019. All the patients in the study were of high stroke risk. RESULTS: A total of 3614 patients with AF and high stroke risk were included. Among the total study population, 91.5% received OAC therapy; antiplatelet therapy was prescribed for 3.7% of patients, heparin for 2.7%, and 2.1% of patients did not receive any stroke prevention therapy. Independent predictors of no OAC prescription were intracranial bleeding (OR 0.15, 95%CI 0.07-0.35, p < 0.001), gastrointestinal bleeding (OR 0.25, 95%CI 0.17-0.37, p < 0.001), cancer (OR 0.37, 95%CI 0.25-0.55, p < 0.001), hospitalization due to acute coronary syndrome (OR 0.48, 95%CI 0.33-0.69, p < 0.001), and anemia (OR 0.62, 95%CI 0.48-0.81, p < 0.001). CONCLUSIONS: Most AF patients with a high thromboembolic risk received OACs. The factors predisposing a lack of OAC use in these patients were conditions that significantly increased the risk of bleeding complications.

Radial approach reduces mortality in patients with ST-segment elevation myocardial infarction and cardiogenic shock.

INTRODUCTION: The beneficial outcome of the radial (RA) over femoral approach (FA) in ST-segment elevation myocardial infarction (STEMI) has been widely demonstrated. However, most of the studies excluded patients with STEMI and cardiogenic shock (CS). OBJECTIVES: We sought to evaluate periprocedural outcomes of percutaneous coronary intervention (PCI) with RA and FA in patients with STEMI complicated by CS using data from the Polish National PCI Registry (ORPKI). PATIENTS AND METHODS: A total of 3,565 consecutive patients with STEMI and CS treated with emergent PCI and stent implantation were included. Data was collected prospectively between 2014 and 2018 from 151 tertiary primary-PCI centers in Poland. To avoid possible selection bias, a propensity score matching (PSM) was used to create 945 matched pairs treated via RA or FA. RESULTS: No differences were reported in baseline characteristics, clinical presentation and delays in treatment between RA and FA after the PSM. Similar radiation doses and the total amount of contrast were used in both groups. A similar rate of periprocedural complications was observed in both RA and FA. However, RA was associated with reduced periprocedural mortality (9.4% (89) vs. 18.6% (176); P=0.001) and lower incidence of cardiac arrest (9.7% (92) vs. 16.1% (152); P=0.001). In multivariable analysis, FA was the strongest independent predictor for increased periprocedural mortality (OR 2.087, 95% CI 1.629-2.674; P=0.001). CONCLUSIONS: The radial approach was associated with lower periprocedural mortality compared with FA in patients with STEMI complicated by CS. RA seems to be a valuable option in technically feasible situations.

Percutaneous coronary intervention during on- and off-hours in patients with ST-segment elevation myocardial infarction.

OBJECTIVE: There are conflicting data on the clinical outcomes of percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) based on the time of admission to the catheterization laboratory. Thus, we aimed to assess clinical outcomes in an unselected cohort of consecutive patients with STEMI treated with PCI during on-and-off hours of work. METHODS: A total of 99,783 patients were included in the analysis. Patients were divided using the most frequently used definition: On-hours (Monday-Friday 07:00 AM-04:59 PM); off-hours (Monday-Friday 05:00 PM-06:59 AM, Saturday, Sunday, and nonworking holidays) (37,469 matched pairs). To avoid potential preselection bias, a propensity score was calculated to compare on-and-off hour groups. RESULTS: Higher radiation doses were observed for PCIs performed during off-hours (1055.2(±1006.5) vs. 1081.6(±1003.25)[mGy] and p = 0.001). A similar prevalence of periprocedural complications was observed during on- and off-hours. However, there was a higher mortality rate during off-hours than during regular working hours (1.17% (439) vs. 1.49% (559) and p = 0.001). CONCLUSIONS: Primary PCIs in STEMI performed during off-hours might be associated with a higher rate of periprocedural mortality and higher radiation doses than procedures conducted during regular working hours.

Characteristics of patients presenting with myocardial infarction with non-obstructive coronary arteries (MINOCA) in Poland: data from the ORPKI national registry.

Myocardial infarction (MI) with non-obstructive coronary arteries (MINOCA) is an important clinical problem especially in the era of extensive utilization of coronary angiography in MI patients. Its pathophysiology is poorly understood which makes diagnostics and treatment of MINOCA challenging in everyday clinical practice. The aim of the study was to assess characteristics of MINOCA patients in Poland based on data from the Polish National ORPKI Registry. In 2016, 49,893 patients with non-ST-segment elevation (NSTEMI) or ST-segment elevation (STEMI) myocardial infarction entered the ORPKI registry. MINOCA was defined as a non-obstructive coronary artery disease (CAD) and a lack of previous coronary revascularization. MINOCA was identified in 3924 (7.8%) patients and clinical presentation was more often NSTEMI than STEMI (MINOCA: 78 vs. 22%; obstructive CAD 51.1 vs. 48.9%; p < 0.0001). MINOCA patients were younger and more often females with significantly lower rates of diabetes, smoking, arterial hypertension, kidney disease, previous MI and previous stroke comparing to patients with obstructive CAD. Myocardial bridge was visualized in angiography more often in the MINOCA group (2.2 vs. 0.4%; p < 0.0001). Additional coronary assessment inducing fractional flow reserve, intravascular ultrasound, optical coherence tomography was marginally (< 1%) used in both groups. Periprocedural mortality was lower in MINOCA group (0.13% vs. 0.95%; p < 0.0001). MINOCA patients represent a significant proportion of MI patients in Poland. Due to multiple potential causes, MINOCA should be considered rather as a working diagnosis after coronary angiography and further efforts should be taken to define the cause of MI in each individual patient.

Impact of On-Site Surgical Backup on Periprocedural Outcomes of Primary Percutaneous Interventions in Patients Presenting With ST-Segment Elevation Myocardial Infarction (From the ORPKI Polish National Registry).

Conflicting data exist regarding the associations between on-site surgical backup and outcomes after primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Thus, we sought to assess the impact of such a backup on periprocedural outcomes of primary PCI using data from the Polish National Registry of PCI. From 2014 to 2016 data on 66,707 patients presenting with STEMI undergoing primary PCI from 154 centers were collected. Patients were divided into 2 groups based on the presence of on-site surgical backup. Of 66,707 patients, 15,040 (22.6%) patients were treated in 28 centers with on-site surgical backup. On-site surgical backup was associated with a higher center PCI annual volume (662.4 ± 301.8 vs 1098.7 ± 483.5; p <0.001), but a lower operator PCI annual volume (226.7 ± 126.0 vs 207.8 ± 96.6; p <0.001). The periprocedural mortality (1.60% vs 1.09%; p <0.001) was lower in patients from centers with on-site cardiac surgery and both on-site surgical backup (odds ratio [95% confidence interval], 0.618 [0.517; 0.738]; p <0.001) and the mean number of PCIs by operator per year (odds ratio per 10 [95% confidence interval], 0.990 [0.984; 0.996]; p = 0.001] were independent predictors of periprocedural death. In conclusion, results of our study suggest that periprocedural mortality in patients undergoing primary PCI for STEMI is lower in centers than without on-site cardiac surgical backup. Whether this effect on mortality is attributable to such backup itself and/or whether surgical backup is a marker of overall better medical care and adherence to professional guidelines, this needs clarification in further studies.

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.

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.

Effect of diabetes mellitus on clinical outcomes and quality of life after transcatheter aortic valve implantation for severe aortic valve stenosis.

BACKGROUND: Diabetes mellitus (DM) is considered a marker of poor prognosis after cardiac surgery. We sought to investigate the effect of DM on clinical outcomes and quality of life (QoL) after transcatheter aortic valve implantation (TAVI). METHODS: A total of 148 consecutive patients with symptomatic, severe aortic stenosis who underwent TAVI were included. Baseline characteristics, procedural and long-term clinical outcomes, and the results of frailty and QoL assessment with EQ-5D-3L questionnaire were compared between patients with and without DM. RESULTS: DM was present in 48 of 148 (32.4%) patients. No differences in periprocedural risk (Logistic Euroscore and Society of Thoracic Surgeons (STS) scale) between groups were observed. There were no differences in 30-day and 12-month all-cause mortality between groups [DM(-) vs. DM(+): 7 (7.0%) vs. 5 (10.4%), p = 0.53 and 12 (12.0%) vs. 10 (20.8%), p = 0.16, respectively]. No influence of DM presence on the risk of death was confirmed after adjustment for age and gender (for 30-day mortality, age/gender-adjusted OR 1.55, 95%CI 0.47-5.17; for 12-month mortality, age/gender-adjusted OR 2.05, 95%CI 0.79-5.32). Similarly, at the longest available follow-up, mortality did not differ between groups [14 (29.2%) vs. 19 (19.0%), p = 0.16; age/gender-adjusted OR 1.81, 95%CI 0.80-4.08]. Similar rates of other complications after TAVI were noted. Frailty measured with the 5-meter walking test was more frequently reported in patients with DM [11 (22.9%) vs. 10 (10.0%), p = 0.035]. No differences in QoL parameters at baseline and 12 months were noted. CONCLUSIONS: Patients with DM undergoing TAVI demonstrated similar mortality, complication rates, and QoL outcomes compared to patients without DM.

Impact of chronic obstructive pulmonary disease and frailty on long-term outcomes and quality of life after transcatheter aortic valve implantation.

BACKGROUND: Association between chronic obstructive pulmonary disease (COPD) and long-term mortality as well as the quality of life (QoL) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) is still unclear. AIM: We sought to evaluate the impact of COPD on mortality and QoL of patients with AS undergoing TAVI. METHODS: A total of 148 consecutive patients who underwent TAVI were enrolled and stratified by history of COPD. RESULTS: Of 148 patients enrolled, 19 (12.8%) patients had a history of COPD. Patients with COPD were high-risk patients with higher prevalence of incomplete revascularization and frailty features. At follow-up of 15.8 months, all-cause mortality in patients with COPD was over four times higher than in patients without COPD [17.8% vs. 52.6%; p = 0.002-age/gender-adjusted OR (95% CI) 4.73 (1.69-13.24)]. On the other hand, in Cox regression model, the only independent predictors of all-cause death at long-term follow-up were: incomplete coronary revascularization [HR (95% CI) 5.45 (2.38-12.52); p = 0.001], estimated glomerular filtration rate [per 1 ml/min/1.73 m2 increase: 0.96 (0.94-0.98); p = 0.001], and previous stroke/transient ischemic attack [2.86 (1.17-7.00); p = 0.021]. Also, the difference in mortality between patients with and without COPD was not significant after adjustment for the most of frailty indices. Importantly, groups were comparable in terms of QoL at baseline and 12 months. CONCLUSION: COPD may pose an important factor affecting long-term outcomes of patients with severe AS undergoing TAVI. However, its effects might be partially related to coexisting comorbidities and frailty.

Reduced periprocedural mortality and bleeding rates of radial approach in ST-segment elevation myocardial infarction. Propensity score analysis of data from the ORPKI Polish National Registry.

AIMS: We sought to evaluate bleeding complications and periprocedural outcomes of the radial approach (RA) as compared to the femoral approach (FA) during percutaneous coronary intervention (PCI) in "real-world" patients with ST-segment elevation myocardial infarction (STEMI). METHODS AND RESULTS: The study group consisted of 22,812 consecutive patients with STEMI treated with PCI and stent implantation between January 2014 and June 2015 in 151 tertiary invasive cardiology centres in Poland (the ORPKI Polish National Registry). Patients treated using the RA and FA were compared using a propensity score analysis to avoid possible selection bias. The analysis was carried out in an "as-treated" manner. The FA was used in 9,334 (40.9%) and the RA in 13,478 (59.1%) patients. After propensity score matching, a higher total amount of contrast (191.8±8.0 vs. 174.8±68.8 ml; p=0.001) and lower radiation doses (1,279.5±1,346.3 vs. 1,182.6±887 mGy; p=0.02) were reported in FA. More access-site-related bleeding complications after both angiography (0.17% vs. 0.02%; p=0.004) and PCI (0.23% vs. 0.09%; p=0.049) were reported in the FA group. Periprocedural death (1.94% vs. 0.93%; p=0.001) was more common after PCI performed with the FA. CONCLUSIONS: The radial approach was associated with a lower incidence of periprocedural death in STEMI patients as well as a significant reduction of bleeding complications at the access site.

Desmoid tumor of lung with pleural involvement - the case of unique location of aggressive fibromatosis.

Desmoid tumors (DTs) are rare mesenchymal neoplasms with unpredictable natural history. There is a high risk of recurrence despite adequate surgical resection, however DTs do not have the capacity to metastasize. The estimated incidence in general population is 2-4 cases/million/year. They may occur at any age but most commonly in the third and fourth decades. Both sexes may be affected, but there is a slight female predominance. DTs can occur at any body site. The exact etiology remains unclear, but trauma, hormonal disturbances, pregnancy, genetic and hereditary factors are postulated to be in association with its' development. Potential to attain large size, infiltration and destruction of adjacent vital structures and tendency to recur are main management problems and important causes of morbidity and mortality. Wide excision is standard first-line treatment of primary or recurrent symptomatic desmoids. We present case of 33-years-old Caucasian female patient admitted to hospital with 2 months history of squeezing pain in right upper quadrant which appeared after meals. The patient was in general good condition. There were no abnormalities on basic laboratory tests on admission. CT of chest revealed hydrothorax to the level of the apex of the right lung and tumor sized 7 × 13 × 13 cm located in the lower lobe of right lung. Histopathological diagnosis of desmoid tumor of right lung was formulated. We report, to our knowledge for the first time in Poland, case of aggressive fibromatosis of lung with invasion of pleura.

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.

Enterocolic lymphocytic phlebitis: an unusual cause of abdominal complaints.

Enterocolic lymphocytic phlebitis (ELP) is a rare disease of unknown etiology involving most often the intramural and mesenteric small and medium-sized veins of the gastrointestinal tract. The diagnosis of the disorder is based on the histopathological examination of a surgical specimen as endoscopically obtained diagnostic material is usually too superficial. Clinical manifestation of ELP most frequently is characterized by acute symptoms, such as acute abdomen, signs suggesting acute appendicitis, gastrointestinal hemorrhage, sometimes it manifests as chronic gastrointestinal complaints. We report, to our knowledge for the first time in Poland, a case of ELP with clinical symptoms pointing to acute appendicitis, on laparoscopy manifesting as a tumorous mass in the colonic wall with an unchanged appendix.