Coronary artery disease (CAD) is a leading cause of heart failure (HF), including HF with severely reduced left ventricular ejection fraction (LVEF ≤ 35%). While revascularization may improve outcomes, optimal treatment strategies remain uncertain, especially in patients with multivessel disease (MVD). To compare long-term outcomes of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) in a real-world cohort of patients with MVD and HF with LVEF ≤ 35%. In this prospective observational study, 586 patients with LVEF ≤ 35% were evaluated by a multidisciplinary Heart Team and assigned to PCI (n = 394) or CABG (n = 192). Outcomes over a 6-year of follow-up included all-cause mortality, hospitalization for HF, myocardial infarction (MI), stroke and need for repeat revascularization (RR). The primary endpoint (all-cause mortality or hospitalization for HF) at 6 years was comparable between both cohorts (56.8% vs. 64.7% for PCI, p = 0.06). We found no significant differences in overall rates of death between CABG and PCI (40.1% vs. 47.4% for PCI, p = 0.09) or hospitalization for HF (27.1% vs. 32.7% for PCI, p = 0.16), however these rates were lower in CABG-cohort. Individuals who underwent PCI had higher incidences of MI and RR (18.8% vs. 9.9% for CABG, p = 0.003 and 25.9% vs. 12.5% for CABG, p = 0.0002, respectively), while higher rates of strokes (9.4% vs. 4.8% for PCI, p = 0.03) penalized CABG. Furthermore, patients who underwent surgery experienced also longer postprocedural hospital stay (9.3 (3.1) vs. 2.8 (1.4) days, p < 0.001). In-hospital mortality was nonsignificantly higher in CABG-cohort (5.2% vs. 2.3% for PCI, p = 0.06). Over a 6-year of follow-up, for real-life all-comer patients with MVD and severe LV dysfunction, we found no significant differences between surgery or percutaneous approach - all-cause mortality and hospitalization for HF were similar, rates of MI and RR favour CABG, while patients who underwent PCI were burdened with lower incidence of stroke. Nevertheless, an increased perioperative risks in this cohort highlight the need for individualized, Heart Team-driven decisions. Further randomized-controlled trials to optimize management in this high-risk population are strongly desirable.
INTRODUCTION:Severe aortic stenosis (AS) can be treated with transcatheter aortic valve implantation (TAVI). There is emerging evidence suggesting that high lipoprotein(a) (Lp[a]) levels may be associated with worse outcomes after TAVI. OBJECTIVES:We aimed to compare major adverse cardiac and cerebrovascular events (MACCEs) within 12 months after TAVI and long‑term survival in patients with high and low Lp(a) levels. PATIENTS AND METHODS:In this prospective, multicenter cohort study we included patients with severe AS qualified for TAVI with stored plasma available for Lp(a) measurement. The patients were stratified into high- and low‑Lp(a) groups (cutoff, 30 mg/dl). Two primary end points were 12‑month MACCE and long‑term overall survival. Secondary end points were individual components of MACCE. RESULTS:Between November 2018 and September 2021, TAVI was performed across 3 clinical sites; stored plasma was available for Lp(a) level measurement in 82 patients. We observed no difference in MACCE occurrence in the high- and low‑Lp(a) groups. In unadjusted analyses, the patients with elevated Lp(a) levels had worse long‑term survival during median follow‑up of 2.8 years (log‑rank P = 0.045) but this difference lost significance after adjustments for age and sex in a Cox regression model (hazard ratio, 2.85; 95% CI, 0.85-9.55; P = 0.054). None of the secondary end points differed significantly between the groups. CONCLUSIONS:The patients with elevated Lp(a) level had a comparable risk of 12‑month MACCE after TAVI to those with low Lp(a) level but might have worse long‑term survival. Long‑term findings should be considered exploratory and require further confirmation.
Fractional flow reserve (FFR) is the gold standard for evaluating the functional significance of coronary stenosis. With advances in methods based on computational fluid dynamics and three-dimensional vessel reconstructions, non-invasive assessment using indices such as vessel FFR (vFFR) has become feasible. To evaluate the association between vFFR and optical coherence tomography (OCT)-derived parameters in patients with chronic coronary syndromes (CCS). In this single-center, prospective, observational study, patients with CCS and intermediate coronary stenoses (40–80
BACKGROUND:Transcatheter aortic valve implantation (TAVI) has become a cornerstone in the treatment of severe aortic stenosis, with expanding indications for lower-risk patients. However, real-world data, especially regarding post-discharge outcomes, from multicenter registries are scarce but needed. AIMS:To evaluate the in-hospital and mid-term outcomes of patients undergoing TAVI in all Polish centers between 2019 and 2023. MATERIAL AND METHODS:Clinical data were extracted from the Polish E-Health database of the National Health Fund. Procedures were identified using specific procedural codes. Long-term outcomes were established based on National Health Fund data, with outcome occurrence derived from the primary/secondary diagnoses for admissions during the one-year duration of follow-up, with a censoring date of December 31, 2023. RESULTS:Between 2019 and 2023, 11 351 TAVIs were performed in Poland. The in-hospital mortality rate was 2.9%. Of the total group, 7860 underwent the procedure between 2019 and 2022, providing a one-year follow-up to the censoring date. In those patients, the overall all-cause 1-year mortality was 12.7%, with higher rates among patients with atrial fibrillation, heart failure, and among men. Myocardial infarction occurred in 1.2%, stroke in 2.3%, and 23.3% patients required hospitalization for heart failure. The 12-month rate of cardiac implantable electronic device implantation was 11.8%. CONCLUSIONS:This study provides the first real-world TAVI outcomes in Polish patients based on the national, multicenter registry, showing an in-hospital mortality of 2.9% and a 12-month all-cause mortality of 12.7%. The 1-year outcomes of patients treated with TAVI in Poland are comparable to international registries.
BACKGROUND:The COAPT risk score, developed based on the COAPT trial, is a tool to predict the risk of death or hospitalization for heart failure (HFH) within two years after transcatheter edge-to-edge repair (TEER) of mitral regurgitation using a MitraClip device. We aimed to validate the Score in a Polish population. METHODS:Patients with severe mitral regurgitation who underwent TEER with MitraClip at three cardiology centers in Poland between November 2015 and February 2023 were included. Patients were divided into two groups based on the COAPT trail criteria: COAPT eligible and COAPT non-eligible. Clinical data were collected from medical records and the COAPT risk score was calculated for each patient. Outcomes were collected during the two-year follow-up period. The primary endpoint was a composite of all-cause mortality and HFH at two-year follow-up and evaluated in the overall cohort and separately for COAPT-eligible and -non-eligible patients. RESULTS:A total of 225 patients were included in the study: 134 COAPT eligible (60%) and 91 COAPT non-eligible (40%). Higher COAPT risk score was associated with increased risk of primary endpoint in the overall population and in COAPT-eligible patients. The score demonstrated moderate discrimination (area under curve [AUC] = 0.581) and poor calibration (Hosmer-Lemeshow [HL] p = 0.085) in the overall population, whereas it showed moderate discrimination (AUC = 0.600) and good calibration (HL p = 0.308) in COAPT-eligible patients. CONCLUSIONS:In Polish patients fulfilling COAPT criteria, the COAPT risk score has moderate predictive value for post-procedural outcomes. In COAPT non-eligible patients, novel tools are required to predict outcomes.
Background: Aortic stenosis (AS) is the most common valvular pathology in Europe and North America, with its prevalence rising due to age-related degeneration and calcification of the aortic valve. The global number of transcatheter aortic valve replacement (TAVR) procedures is rapidly increasing. Nevertheless, the ischemic cerebrovascular events remain among the most significant complications of this procedure. This study aimed to assess the long-term incidence of neurological events and identify the most powerful predictors of stroke following TAVR in a high-volume cardiovascular care center. Methods: 705 patients who underwent TAVR between January 2016 and September 2022, with a median follow-up of 60 months were analyzed. Baseline patient characteristics, procedural data, and long-term neurological outcomes were evaluated. Results: At five years the cumulative incidence of any neurological events, strokes and disabling strokes reached 28.5%, 20.3% and 13.2%, respectively. Periprocedural strokes occurred in 1.4% of patients. The multivariable analysis performed was aimed at identifying the relationship between a range of clinical and procedural variables and the incidence of stroke within five years following TAVR. Conclusions: The findings highlight the importance of long-term neurological follow-up after TAVR, as stroke mechanisms evolve over time - from periprocedural embolization to thrombus formation or chronic conditions like frailty and atherosclerosis. Future research should focus on more targeted stroke prevention and long-term management strategies enhancing safety for the TAVR recipient population.
BACKGROUND Many randomized controlled trials have explored the optimal revascularization strategy for patients with diabetes, but real-life outcomes are still poorly investigated. We assessed the complete 6-year outcomes of diabetic individuals with multivessel coronary artery disease (MVD) treated either with coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). MATERIAL AND METHODS We reviewed data of all patients from 176 local Heart Team meetings and their treatment recommendations and assessed primary and secondary endpoints of 317 MVD patients with diabetes qualified either for CABG or PCI (98 and 219 patients, respectively) with subsequent optimal medical therapy. RESULTS At 6 years, no significant difference in overall mortality was observed (16.3% vs 20.5% for PCI, P=0.38). The incidence of myocardial infarction (MI) was higher in patients treated percutaneously (4.1% vs 12.3% for PCI, P=0.02), while those undergoing CABG had significantly longer postprocedural hospital stay (10.7 vs 4.4 days for PCI, P<0.01). The occurrence of major adverse cardiac and cerebrovascular events (MACCE), mainly driven by the increased rate of repeat revascularization (RR), was higher in the PCI group (83.6% vs 44.9%, P<0.01 and 47.0% vs 17.3%, P<0.01, respectively). The rates of stroke and in-hospital mortality were similar between the 2 groups. CONCLUSIONS For MVD patients with diabetes, CABG was superior in real-life clinical practice in terms of rates of MI, RR, and MACCE, while postprocedural hospital stays were shorted with PCI. The rates of all-cause death, stroke, and in-hospital mortality were comparable between groups.
Objectives: The aim of this study is to evaluate the safety and efficacy of repeat transcatheter aortic valve implantation (redo-TAVI) in the polish population. Methods: In this multicentre nationwide registry (ClinicalTrials.gov identifier, NCT03361046), we provide characteristics, periprocedural variables and long-term outcomes of high-risk patients who underwent redo-TAVI. Results: The mean age among 32 individuals who underwent redo-TAVI was 75 ± 13 years, and 62.5% were male. The mean time from index TAVI to redo-TAVI was 4.7 ± 3.5 years, with failed procedures (up to 1 year) occurring in 7 (21.9%) and failed transcatheter heart valve (THV, beyond 1 year) in the remaining majority of the 25 (78.1%) patients. Computed tomography-based native bicuspid aortic anatomy was found frequently in 37.5% of cases (58.3% in failed procedures and 41.7% in failed THV). The mean failed THV size was large (27.7 ± 3 mm) and predominantly presenting with pure regurgitation (59.4%). In more than two-thirds (68.7%), balloon-expandable or self-expandable THV was the most common strategy of redo-TAVI. None or mild regurgitation was found in 90.6%, and the mean transvalvular gradient was 13.1 ± 5.5 mmHg, with only three cases with >20 mmHg of the residual gradient (9.4%). Peri-procedural and 30-day complications were low, and cardiovascular and all-cause mortality at 1 year was 9.4 and 15.6%, respectively. There was a relatively high incidence of non-procedural stroke after redo-TAVI (n = 5, 15.6%), with all cases observed after 30 days. Conclusions: Initial data of redo-TAVI in Poland suggest that the procedure is safe and characterized by favourable efficacy and low rates of short-term adverse outcomes. A high frequency of baseline native bicuspid anatomy and late stroke occurrence after the redo-procedure warrants further investigation in larger cohorts.
Background: Tricuspid regurgitation (TR) is a common valvular heart disease that often causes disabling symptoms. Caval valve implantation with the TricValve system is one of the transcatheter treatment options proposed for TR symptom reduction. With this prospective registry, we aim to summarize our early experience with TricValve system implantation. Methods: Registry participants, selected out of patients who were referred for TR treatment but who were not eligible for the transcatheter tricuspid edge-to-edge valve repair (T-TEER), were qualified for the caval valve implantation following a HeartTeam discussion. Results: Four patients (four women; median age 71 years; 67.5-77 years) in whom a one-year follow-up was completed were included in the study. The patients were highly symptomatic in the NYHA class III despite intensive diuretic treatment; all of them were considered a high-mortality risk during conventional cardiac surgery. The TricValve system was successfully implanted in all patients. At 6-month follow-up, we observed a reduction in symptoms in three out of four patients. Up to 12 months, only one patient survived, with a reduction in symptoms of NYHA class II; two patients died because of heart failure; one died due to a progression in neoplastic disease. Conclusions: In highly symptomatic TR patients who were not eligible for the T-TEER and who had a prohibitive risk of cardiac surgery, TricValve implantation led to a reduction in symptoms in a 6-month perspective. Long-term survival was limited mainly by heart failure progression and severe concomitant disorders. Further studies are needed to fully elucidate the role of caval valve implantation in the treatment of TR patients.
INTRODUCTION:Impella CP is a percutaneous left ventricular assist device used in selected patients undergoing high‑risk percutaneous coronary interventions (HR‑PCIs). To improve outcomes of Impella‑supported HR‑PCI, institutional Impella programs have been developed. OBJECTIVES:We evaluated the association between the use of a standardized periprocedural management algorithm and outcomes of patients undergoing HR‑PCI included in the national IMPELLA‑PL registry. PATIENTS AND METHODS:Consecutive patients undergoing HR‑PCI supported with Impella CP (n = 253), enrolled in the IMPELLA‑PL registry between January 2014 and December 2021, were retrospectively divided into those fulfilling (n = 77) and not fulfilling (n = 176) the criteria of a standardized management algorithm, as proposed in the Roadmap Towards an Institutional Impella Program for HR‑PCI (ROAD TIP). RESULTS:Implementation of the standardized management algorithm allowed for selection of patients at a higher baseline risk, manifested by higher prevalence of acute coronary syndrome (P = 0.001), higher EuroScore (P = 0.02), and greater coronary artery disease complexity (P = 0.003). It also allowed for performing more complex PCI procedures, including a higher proportion of left main PCIs (P = 0.005), bifurcation PCIs (P <0.001), and use of calcium modification techniques (P = 0.02), more frequent Impella implantation before PCI (P = 0.002), and a higher proportion of ultrasound‑guided punctures (P <0.001). Despite higher baseline risk and greater procedural complexity, 12‑month outcomes of the patients treated according to the ROAD TIP algorithm were comparable to those of the individuals not fulfilling the algorithm criteria, who had a more favorable risk profile and underwent less complex procedures. In low‑volume centers, 12‑month mortality was lower in the standardized management group (P = 0.047), whereas in high‑volume centers, it was comparable between the groups. CONCLUSIONS:Implementation of a dedicated management algorithm might improve outcomes of Impella‑assisted HR‑PCI, especially in low‑volume centers.
Background/Objectives: The aim of this study was to analyze the presence of vasa vasorum in optical coherence tomography (OCT) among patients undergoing coronary angiogram for chronic coronary syndrome with intermediate-grade coronary stenoses in relation to long-term follow-up. Methods: This prospective, observational, single-center study enrolled patients with chronic coronary syndrome and intermediate-grade coronary stenosis. OCT was used to assess the presence of vasa vasorum, type of plaque, mean lumen area, fibrous cap thickness (FCT), and minimal lumen diameter. Patients were divided into two groups based on the presence of vasa vasorum. Results: Overall, 97 patients were enrolled, of whom 82.5% were male. Lesions with vasa vasorum were found in 76 patients. Comorbidities such as diabetes mellitus, hypertension, dyslipidemia, and chronic kidney disease did not differ significantly between groups. Among patients with vasa vasorum, there were higher serum creatinine levels (1.03 ± 0.24 vs. 0.87 ± 0.22, p = 0.009). OCT showed that minimal lumen diameter differed between groups (2.26 ± 0.38 mm vs. 2.57 ± 0.57 mm p = 0.026) for the vasa vasorum group and no vasa vasorum, respectively, however minimal lumen area was similar in both groups (3.88 ± 1.76 mm2 vs. 4.01 ± 2.00 mm2, p = 0.731, for vasa vasorum and no vasa vasorum, respectively). Furthermore, the presence of vasa vasorum seemed to have no significant correlation with cardiovascular events in the 2-year, 5-year, and 10-year follow-up. Conclusions: The presence of lesions with vasa vasorum was not shown to be linked to any unfavorable patients’ outcomes. Among men, coronary atherosclerotic plaques were more likely to contain OCT-visualized vasa vasorum.
Background: The optimal revascularization strategy for patients with left main coronary artery (LMCA) disease has been repeatedly addressed in randomized controlled trials (RCTs), although outcomes from real-life clinical studies are still poorly investigated. Objectives: This retrospective study aimed to assess the complete 5-year outcomes for individuals with multivessel coronary artery disease (MVD) involving LMCA disease treated with coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) as recommended by a local HT. Methods: From 2016 to 2019, 176 Heart Team (HT) meetings were held. Primary and secondary endpoints of 267 patients with MVD involving LMCA disease qualified either for CABG or PCI (109 and 158 patients, respectively) with subsequent optimal medical therapy (OMT) were assessed. The primary endpoint of the study was as an overall mortality, while secondary endpoints contained major adverse cardiac and cerebrovascular events (MACCE)—specifically, stroke, myocardial infarction (MI), repeat revascularization (RR), and the individual components of MACCE. Results: At 5 years, we found no significant difference in overall mortality between the both cohorts (22.9%-CABG vs. 24.7%-PCI, p = 0.74). The rate of MI was higher in patients treated percutaneously (7.3% vs. 15.8% for PCI, p = 0.04), while the incidence of stroke was higher in patients who underwent CABG (3.8% vs. 11.0% for CABG, p = 0.02). A MACCE occurrence was higher in PCI cohort (77.2% vs. 55.0%, p < 0.001), mainly driven by higher rates of RR was higher in patients treated percutaneously (32.9% vs. 13.8%, p < 0.001). Conclusions: For patients with LMCA disease, neither CABG nor PCI following HT decisions showed overwhelming superiority in real-life clinical practice: occurrence of all-cause death was similar, rates of MACCE, MI, and repeat revascularization advocated CABG, while incidence of strokes favored PCI.