Impact of chronic total occlusion on prognosis in cardiogenic shock due to unprotected left main coronary artery culprit lesion. Insights from the Polish Registry of Acute Coronary Syndromes.

BACKGROUND: Notwithstanding readily available revascularization, significant advancements in mechanical circulatory support, and pharmacological progress, cardiogenic shock (CS) secondary to unprotected left main culprit lesion-related acute myocardial infarction (ULMCL-related AMI) is associated with very high mortality. In this population, chronic total occlusion (CTO) is relatively frequent. AIMS: This study sought to assess the association between the presence of CTO and 12-month mortality in patients with CS due to ULMCL-related AMI. RESULTS: The study included consecutive patients admitted for AMI-related CS with ULMCL who underwent percutaneous coronary intervention (PCI) and were enrolled in the prospective Polish Registry of Acute Coronary Syndromes (PL-ACS) between January 2017 and December 2021. The patients were stratified into two groups based on the presence of at least one CTO. The primary endpoint was all-cause death at 12 months. Of the 250 included patients, 60 (24%) patients had one or more CTOs of a major coronary artery (+CTO), and in 190 (76%) patients, the presence of CTO was not observed (-CTO). The 12-month mortality rates for the +CTO and -CTO patients were 85% and 69.8%, respectively (P log-rank = 0.03). After multivariable adjustment for differences in the baseline characteristics, the presence of CTO remained significantly associated with higher 12-month mortality (hazard ratio, 1.423; 95% CI, 1.027-1.973; P = 0.034). CONCLUSIONS: Our analysis showed that in patients with CS due to ULMCL-related AMI treated with PCI, the presence of CTO is associated with worse 12-month prognosis.

Double protection in patients with a massive thrombus in the infarct-related artery - a single-center retrospective study.

Introduction: ST-segment elevation myocardial infarction (STEMI) is associated with thrombus formation on a ruptured or ulcerated atherosclerotic plaque. The consequences of a massive thrombus (MT) may include lack of reperfusion, extensive myocardial infarction (MI) and its complications. Although there are various treatment options for patients with coronary thrombi, double protection (DP) - manual thrombectomy (MTH) with a distal protection device (DPD) - has not been tested yet. Aim: To present DP outcomes in the treatment of patients with STEMI and MT patients. Material and methods: Fourteen patients with STEMI and MT were included in the study. Those patients underwent primary percutaneous coronary intervention (PPCI) with DP. Results: Inferior MI was found in 12 (85.8%) patients. Stents were implanted in 13 (92.8%) patients. Thrombolysis In Myocardial Infarction (TIMI) Thrombus Grade 5 was present in 11 (78.6%) patients and Grade 4 in 3 (21.4%) patients. The median thrombus length was 39.1 mm. Complete reperfusion (TIMI flow 3) was observed in 11 (78.6%) patients and TIMI flow 2 in 3 (21.4%) patients. Myocardial Blush Grade (MBG) was used in patients with TIMI flow 3 and Grade 3 was found in 5 (35.7%) patients. Resolution in ST-segment elevation > 50% was obtained in 13 (92.8%) patients. No myocardial rupture, stroke, or death occurred during hospitalization. Conclusions: DP in MT patients is a safe and feasible procedure. However, further observations and studies are needed to assess the efficacy of this method.

Stepwise relationship between delay in percutaneous coronary intervention and long-term mortality in patients with non-ST-segment elevation myocardial infarction.

BACKGROUND: Current guidelines recommend coronary catheterization in patients with non-ST- -segment elevation myocardial infarction (NSTEMI) within 24 hours of hospital admission. However, whether there is a stepwise relationship between the time to percutaneous coronary intervention (PCI) and long-term mortality in patients with NSTEMI treated invasively within 24 hours of admission has not been established yet. AIMS: The study aimed to evaluate the association between door-to-PCI time and all-cause mortality at 12 and 36 months in NSTEMI patients presenting directly to a PCI-capable center who underwent PCI within the first 24 hours of hospitalization. METHODS: We analyzed data of patients hospitalized for NSTEMI between 2007-2019, included in the nationwide registry of acute coronary syndromes. Patients were stratified into twelve groups based on 2-hour intervals of door-to-PCI time. The mortality rates of patients within those groups were adjusted for 33 confounding variables by the propensity score weighting method using overlap weights. RESULTS: A total of 37 589 patients were included in the study. The median age of included patients was 66.7 (interquartile range [IQR], 59.0-75.8) years; 66.7% were male, and the median GRACE (Global Registry of Acute Coronary Events) score was 115 (98-133). There were increased 12-month and 36-month mortality rates in consecutive groups of patients stratified by 2-hour door-to-PCI time intervals. After adjustment for patient characteristics, there was a significant positive correlation between the time to PCI and the mortality rates (rs = 0.61; P = 0.04 and rs = 0.65; P = 0.02 for 12-month and 36-month mortality, respectively). CONCLUSIONS: The longer the door-to-PCI time, the higher were 12-month and 36-month all-cause mortality rates in NSTEMI patients.

Comparison of outcomes in patients with severe aortic stenosis treated with small and large Medtronic Evolut R and Evolut PRO self-expandable prosthetic valves.

Introduction: Indications for transcatheter aortic valve implantation (TAVI) continue to expand. Very often TAVI must be done in large annuli. Implantation of the bigger prostheses is often associated with more procedural problems, which may affect the outcomes. Aim: To compare the outcomes of TAVI procedures using the self-expandable Medtronic Evolut R 34 with the smaller Evolut R or Evolut Pro 23, 26 or 29. Material and methods: We analysed 87 patients who received self-expandable Medtronic Evolut R and Pro valves. Group I consisted of 59 (67.81%) patients with Evolut 23, 26 or 29, and group II consisted of 28 (32.18%) patients who received an Evolut 34 valve. Results: EuroSCORE II was 5.59 in group I vs 7.87 in group II (p = 0.02). The oversizing rate was higher in group II: 24.1% vs. 18.5% (p < 0.001). The procedure and fluoroscopy times were longer in group II: 209 vs. 187 min (p = 0.03), 44 vs. 27 min (p = 0.01). Moderate paravalvular leak was found more frequently in group II: 5 v 1 (p = 0.04). There was less device success in group II: 22 (78.57%) vs. 57 (96.6%) (p = 0.05). Early safety criteria were similar in both groups: 52 (88.1%) and 24 (92.3%) (p = 0.56). 30-day mortality was similar: 4 (6.7%) vs. 0 in group I and II respectively (p = 0.16). Conclusions: TAVI procedures in patients requiring an Evolut R 34 prosthesis are more challenging than in those who need smaller valves. Paravalvular leaks are more frequently observed after TAVI with Evolut R 34, which results in lower device success.

Transcatheter Versus Surgical Valve Replacement: A 24-months Propensity-matched Analysis of the SILCARD Registry.

BACKGROUND: Data concerning the comparison between transcatheter aortic valve implantation and surgical aortic valve replacement in a real-world setting are scarce and in Central and Eastern Europe no such data exist. In this study, we aimed at analyzing retrospectively the characteristics and outcome of patients with aortic stenosis treated either with surgical aortic valve replacement or transcatheter aortic valve implantation between 2006 and 2016 in the Silesian Province, Poland in a representative real-world cohort. METHODS: In the Silesian Cardiovascular Database we retrospectively identified 5186 patients who received either transcatheter aortic valve implantation or surgical aortic valve replacement in 1 of 3 tertiary cardiovascular centers. Baseline characteristics, including relevant clinical history, and outcomes were compared before and after propensity-score matching of both groups, with 348 pairs of patients constituting the propensity-matched study cohort. The primary end-point was 24-month all-cause mortality. RESULTS: Preoperative characteristics of propensity-matched groups were similar. There was no difference between transcatheter aortic valve implantation and surgical aortic valve replacement groups with respect to the death rate at 2 years (19.9% vs. 15.6%; P =.479). In the transcatheter aortic valve implantation group, cardiac resynchronization therapy devices were more frequently implanted after the procedure (3.7% vs. 0.0, P <.001). The groups had similar rates of myocardial infarction, stroke, and re-hospitalization. Hospital stay in the matched groups was shorter after transcatheter aortic valve implantation: 14.1 versus 15.7 days (P <.001). CONCLUSIONS: At 24 months, transcatheter aortic valve implantation patients had similar outcomes as surgical aortic valve replacement except for a higher rate of cardiac resynchronization therapy device implantation and shorter hospital stay.

Transcatheter aortic valve­in­valve implantation for failed surgical bioprostheses: results from the Polish Transcatheter Aortic Valve-in-Valve Implantation (ViV­TAVI) Registry

INTRODUCTION: Transcatheter aortic valve­in ­valve implantation (ViV­TAVI) has emerged as an alternative to redo surgery in patients with failed surgical aortic bioprosthesis. OBJECTIVES: We evaluated the safety and efficacy of ViV­TAVI in Polish patients after surgical aortic valve replacement. PATIENTS AND METHODS: This was a nationwide multicenter registry of ViV­TAVI procedures. Data were collected using an online form, and the clinical follow ­up lasted 1 year. RESULTS: From 2008 to 2020, 130 ViV­TAVI procedures were performed (1.9% of all transcatheter aortic valve implantation [TAVI] cases). A considerable increase in ViV­TAVI procedures since 2018 has been observed (n = 59, 45% of ViV­TAVI cases). Hancock II, Freestyle, and homograft were the most frequently treated bioprostheses. The self ­expanding supra ­annular Corevalve / Evolut valve was used in 76% of cases. In 21% of cases, the mean postprocedural pressure gradient (PG) exceeded 20 mm Hg. All­cause mortal­ity at 1 year was 10.8%. Aortic valve stenosis was associated with a higher mean PG than aortic valve regurgitation or mixed disease (P = 0.004). Supra ­annular transcatheter aortic valves were associated with lower mean PGs than intra ­annular valves (P = 0.004). Second ­generation devices were associated with shorter procedure time (120 min vs 135 min, P = 0.04), less frequent need for additional TAVI (2% vs 10%, P = 0.04), and lower 1­year cardiovascular mortality (95% vs 82.8%, P = 0.03) than first­generation valves. CONCLUSIONS: Transcatheter treatment of failed bioprostheses is increasingly common, with the best hemodynamic effect shown for supra ­annular valves. The introduction of second­generation valves has improved procedural and clinical outcomes.

Development and Validation of a Practical Model to Identify Patients at Risk of Bleeding After TAVR.

OBJECTIVES: No standardized algorithm exists to identify patients at risk of bleeding after transcatheter aortic valve replacement (TAVR). The aim of this study was to generate and validate a useful predictive model. BACKGROUND: Bleeding events after TAVR influence prognosis and quality of life and may be preventable. METHODS: Using machine learning and multivariate regression, more than 100 clinical variables from 5,185 consecutive patients undergoing TAVR in the prospective multicenter RISPEVA (Registro Italiano GISE sull'Impianto di Valvola Aortica Percutanea; NCT02713932) registry were analyzed in relation to Valve Academic Research Consortium-2 bleeding episodes at 1 month. The model's performance was externally validated in 5,043 TAVR patients from the prospective multicenter POL-TAVI (Polish Registry of Transcatheter Aortic Valve Implantation) database. RESULTS: Derivation analyses generated a 6-item score (PREDICT-TAVR) comprising blood hemoglobin and serum iron concentrations, oral anticoagulation and dual antiplatelet therapy, common femoral artery diameter, and creatinine clearance. The 30-day area under the receiver-operating characteristic curve (AUC) was 0.80 (95% confidence interval [CI]: 0.75-0.83). Internal validation by optimism bootstrap-corrected AUC was 0.79 (95% CI: 0.75-0.83). Score quartiles were in graded relation to 30-day events (0.8%, 1.1%, 2.5%, and 8.5%; overall p <0.001). External validation produced a 30-day AUC of 0.78 (95% CI: 0.72-0.82). A simple nomogram and a web-based calculator were developed to predict individual patient probabilities. Landmark cumulative event analysis showed greatest bleeding risk differences for top versus lower score quartiles in the first 30 days, when most events occurred. Predictivity was maintained when omitting serum iron values. CONCLUSIONS: PREDICT-TAVR is a practical, validated, 6-item tool to identify patients at risk of bleeding post-TAVR that can assist in decision making and event prevention.

Comparison of the results of transcatheter aortic valve implantation in patients with bicuspid and tricuspid aortic valve.

INTRODUCTION: Indications for transcatheter aortic valve implantation (TAVI) are constantly expanding, including younger patients. Bicuspid aortic valves (BAV) often occur in this group. In order to achieve optimal treatment results in younger patients, it is necessary to develop an effective method for selecting the size of implanted valves. AIM: To compare the results of TAVI with use of a self-expanding prosthesis in patients with a BAV and a tricuspid aortic valve (TAV) with valve selection based on annular sizing. MATERIAL AND METHODS: The diagnosis of BAV and TAV and measurements (annular sizing) were based on multi-slice computed tomography scans. Eighty-three patients received a self-expanding CoreValve or Evolut R prosthesis. In group I (BAV) there were 21 (25.3%) patients and in group II (TAV) there were 62 (74.7%) patients. RESULTS: The groups did not differ in terms of baseline clinical characteristics. Device success was achieved in 16 (76.2%) and 55 (88.7%) (p = NS) in group I and II respectively. Composite endpoints: early safety occurred in 5 (23.8%) and 11 (17.7%) patients (p =NS) in group I and II respectively; clinical efficacy occurred in 10 (47.6%) and 28 (45.2%) patients (p = NS) in group I and II respectively. 30-day mortality was 4.8% vs 9.7%, 1-year mortality was 28.6% vs 17.7% (p = NS) in group I and II respectively. CONCLUSIONS: TAVI in patients with severe aortic stenosis and BAV is as effective as in patients with TAV using self-expanding prostheses if the valve selection is based on annular sizing.

Long-term outcomes of 11 021 patients with chronic coronary syndromes and after coronary angiography: the PRESAGE registry.

INTRODUCTION: There is a paucity of real­world registries concerning patients with chronic coronary syndromes (CCS). OBJECTIVES: We aimed to assess the long­term outcomes of patients with CCS and after coronary angiography performed in accordance with the treatment strategy. PATIENTS AND METHODS: The analysis involved 11 021 patients treated in a single center between 2006 and 2016 who were enrolled into the ongoing PRESAGE registry. Based on the results of coronary angiography and the treatment strategy adopted, patients were classified into 4 groups: with nonsignificant lesions (n = 3637), undergoing percutaneous coronary intervention (n = 4678), undergoing coronary artery bypass grafting (CABG; n = 997), and receiving conservative treatment (notwithstanding significant lesions on an angiogram; n = 1709). All­cause death, assessed in every study group at 1-, 3-, and 5­year follow­up, was regarded as the primary outcome measure. RESULTS: The mean (SD) age of the study patients was 64.6 (9.5) years, and women constituted 35% of the cohort. Patients treated conservatively were the oldest (mean [SD] age, 64.9 [9.3] years) in the group and showed the highest prevalence of previous myocardial infarction (50.5%), CABG (31.8%), diabetes (40.3%), chronic total occlusion (65.5%), and left ventricular ejection fraction below 35% (24.4%). Death from any cause in patients with nonsignificant lesions, undergoing percutaneous coronary intervention, undergoing CABG, and receiving conservative treatment occurred 5 years following the index hospitalization in 11.2%, 16.2%, 9.7%, and 21% of those patients, respectively. CONCLUSIONS: The PRESAGE registry provides valuable information about the clinical characteristics and long­term outcomes of patients with CCS. The population of CCS patients is heterogeneous, and long­term prognosis is also varied. The poorest characteristics and outcomes were reported in patients with significant lesions and ineligible for revascularization procedures.

Gender-related disparities in the treatment and outcomes in patients with non-ST-segment elevation myocardial infarction: results from the Polish Registry of Acute Coronary Syndromes (PL-ACS) in the years 2012-2014.

INTRODUCTION: Gender-related differences in the treatment of patients with non-ST elevation myocardial infarction (NSTEMI) have been reported in many previous studies despite the fact that an equal approach is recommended in all current guidelines. The aim of the study was to investigate whether gender-related discrepancies in the management of NSTEMI patients have changed. MATERIAL AND METHODS: Between 2012 and 2014 a total of 66,667 patients (38.3% of whom were women) with the final diagnosis of NSTEMI were included into the retrospective analysis of the Polish Registry of Acute Coronary Syndromes (PL-ACS). Differences in clinical profile, treatment, and outcomes were analysed. RESULTS: Women were older than men and more often had comorbidities. They were less likely to undergo coronary angiography (88.4% vs. 92.1%, p < 0.05) as well as percutaneous coronary intervention (59.6% vs. 71.9%, p < 0.05). In the general population women had also significantly worse in-hospital prognosis as well as in 12-month follow-up. After the age adjustment the outcomes in women were at least as good as in men. In multivariate analysis females had the same risk as men in-hospital RR = 1.02 (95% CI: 0.97-1.08, p = 0.45) and lower in 12-month observation RR = 0.94 (95% CI: 0.92-0.97, p < 0.0001). CONCLUSIONS: In comparison with previous reports on NSTEMI patients, gender-related disparities in the treatment and outcomes were radically reduced. Unadjusted mortality rates were still higher in women as a consequence of their older age. After the age adjustment, mortality ratios were similar in both genders. The long-term prognosis seems to be even better in women.

Female gender and the clinical and periprocedural profile and clinical outcomes of transcatheter aortic valve implantation: experiences of a tertiary Polish centre.

INTRODUCTION: Despite the establishment of multiple factors influencing short- and mid-term outcomes in patients treated with transcatheter aortic valve implantation (TAVI), the real-world data on the association between gender and outcomes after TAVI remain conflicting. AIM: To evaluate the association of female gender with the clinical and periprocedural characteristics along with in-hospital, short- and medium-term outcomes of patients treated with TAVI in comparison with male patients. MATERIAL AND METHODS: Data from the prospective, single-centre registry of consecutive patients with severe AS referred for TAVI from 26 November 2008 to 31 December 2018 were analysed retrospectively. The study population comprised 275 patients who were divided by gender. The primary endpoint of the study was all-cause mortality at 1 year. RESULTS: Women constituted 132 (48.0%) of the overall population. Women were significantly older, but had a significantly higher left ventricular ejection fraction (LVEF) and had less frequently undergone coronary artery bypass grafting (CABG) before TAVI. The implantation success rate was comparable between genders, but women less frequently required implantation of a pacemaker after TAVI, although they more frequently required blood transfusion due to severe bleeding. The primary endpoint occurred in 13.6% of women and 7.7% of men (p = 0.12). CONCLUSIONS: Despite advanced age and prevalence of cardiovascular risk factors, the overall short- and medium-term mortality in patients treated with TAVI in our analysis of the real-world population remains relatively low. Although women seemed to have a slightly better clinical baseline profile, their in-hospital, 30-day, 6-month and 12-month outcomes did not differ significantly from the male patients.

Impact of routine invasive strategy on outcomes in patients with non-ST-segment elevation myocardial infarction during 2005-2014: A report from the Polish Registry of Acute Coronary Syndromes (PL-ACS).

BACKGROUND: Non-ST-segment elevation myocardial infarction (NSTEMI) has become the most frequently encountered type of myocardial infarction. The patient clinical profile and management has evolved over the past decade. As there is still a scarcity of data on the latest trends in NSTEMI, changes herein were observed and assessed in the treatment and outcomes in Poland between 2005 and 2014. METHODS: A total of 197,192 patients with NSTEMI who enrolled in the Polish Registry of Acute Coronary Syndromes (PL-ACS) between 2005 and 2014 were analyzed. In-hospital and 12-month mortality were assessed. RESULTS: Coronary angiography use increased from 35.8% in 2005-2007 to 90.7% in 2012-2014 (p < 0.05), whereas percutaneous coronary intervention increased from 25.7% in 2005-2007 to 63.6% in 2012-2014 (p < 0.05). There was a 50% reduction in in-hospital mortality (from 5.6% in 2005-2007 to 2.8% in 2012-2014; p < 0.05) and a 30% reduction in 1-year mortality (from 19.4% in 2005-2007 to 13.7% in 2012-2014; p < 0.05). A multivariate analysis confirmed an immense impact of invasive strategy on patient prognosis during in-hospital observation with an odds ratio (OR) of 0.31 (95% confidence interval [CI] 0.29-0.33; p < 0.05) as well as during the 12-month observation with an OR of 0.51 (95% CI 0.49-0.52; p < 0.05). CONCLUSIONS: Over the past 10 years, an important advance in the management of NSTEMI has taken place in Poland. Routine invasive strategy resulted in a significant decrease in mortality rates in all groups of NSTEMI patients.

Percutaneous access to coronary arteries in patients after transcatheter aortic valve implantation procedures - is it a real problem?

Transcatheter aortic valve implantation (TAVI) is still developing and changing our approach to treating patients with severe symptomatic aortic stenosis. Aortic stenosis frequently coexists with coronary artery disease. Both diseases have similar risk factors for their development and one should expect a future progression of coronary artery disease. The current guidelines have expanded TAVI indications to include intermediate-risk patients, and perhaps they will be expanded to include low-risk patients in the future. Survival after TAVI in younger patients will depend on the durability of the aortic valves and methods of coronary artery disease treatment. This paper presents some aspects of performing coronary angiography and percutaneous coronary intervention in patients who had TAVI performed using the two most popular aortic valves - balloon expandable aortic valves (Edward Sapien/Edward Sapien XT/Sapien 3) and self-expandable aortic valves (CoreValve/Evolut R) - on the basis of several examples. This paper also focuses on technical aspects associated with a proper implantation of aortic valves to ensure easy access to coronary arteries, as well as on possible problems when the implantation is not optimal. We discuss interactions between the structure of the aortic valve stent, catheters, commissures of new aortic valves, and coronary ostia.