Thrombus containing lesions strategies during primary percutaneous coronary interventions in ST-segment elevation myocardial infarction: insights from ORPKI National Registry.

In the era of potent P2Y12 inhibitors, according to current guidelines, treatment with glycoprotein IIb/IIIa inhibitors (GPIs) should be limited to bail-out and/or highly thrombotic situations. Similarly, the recommendation for aspiration thrombectomy (AT) is downgraded to very selective use. We examine the prevalence, and predictors of GPI and AT use in STEMI patients referred to primary percutaneous coronary intervention (PCI). Data on 116,873 consecutive STEMI patients referred to primary PCI in Poland between 2015 and 2020 were analyzed. GPIs were administered in 29.3%, AT was used in 11.6%, and combined treatment with both in 6.1%. There was a mild trend toward a decrease in GPI and AT usage during the analyzed years. On the contrary, there was a rapid growth of the ticagrelor/prasugrel usage rate from 6.5 to 48.1%. Occluded infarct-related artery at baseline and no-reflow during PCI were the strongest predictors of GPI administration (OR 2.3; 95% CI 2.22-2.38 and OR 3.47; 95% CI 3.13-3.84, respectively) and combined usage of GPI and AT (OR 4.4; 95% CI 4.08-4.8 and OR 3.49; 95% CI 3.08-3.95 respectively) in a multivariate logistic regression model. Similarly, the administration of ticagrelor/prasugrel was an independent predictor of both adjunctive treatment strategies. In STEMI patients in Poland, GPIs are selectively used in one in four patients during primary PCI, and the combined usage of GPI and AT is marginal. Despite the rapid growth in potent P2Y12 inhibitors usage in recent years, GPIs are selectively used at a stable rate during PCI in highly thrombotic lesions.

Experience with Optical Coherence Tomography Enhanced by a Novel Software (Ultreon™ 1.0 Software)-The First One Hundred Cases.

Introduction: Optical coherence tomography (OCT) intravascular imaging including the latest version Ultreon™ 1.0 Software (Abbott Vascular, Santa Clara, CA, USA), not only improve patients prognosis, but also facilitates improved percutaneous coronary intervention (PCI). Objectives: The aim of the study was to compare procedure related decision making, procedural indices, clinical outcomes according to the extent of stent expansion and assess risk factors of underexpansion in patients treated with PCI using OCT. Methods: The study comprised 100 patients, which were divided in groups according to the extent of stent expansion: <90 (29 patients) and ≥90% (71 patients). Comparison of OCT parameters, selected clinical and procedural characteristics was performed between groups. We assessed clinical outcomes during the follow-up: major adverse cardiovascular events and risk factors of stent underexpansion. Results: Patients from the stent underexpansion group were treated more often in the past with percutaneous peripheral interventions (p=0.02), no other significant differences being noted in general characteristics, procedural characteristics or clinical outcomes comparing both groups. Significant predictors of stent underexpansion assessed by simple linear univariable analysis included: hypercholesterolemia, obstructive bronchial diseases and treatment with inhalators, family history of cardiovascular disease, PCI of other than the left main coronary artery, stent and drug-eluting stent implantation, PCI without drug-eluting balloon, paclitaxel antimitotic agent, greater maximal stent diameter and lower mean Euroscore II value. Univariable logistic regression analysis revealed a correlation between stent underexpansion and greater creatinine serum concentration before [OR: 0.97, 95%CI: 0.95-0.99, p=0.01] and after PCI [OR: 0.98, 95%CI: 0.96-0.99, p=0.02]. Conclusions: Based on the presented analysis, the degree of stent expansion is not related to the selected procedural, OCT imaging indices and clinical outcomes. Logistic regression analysis confirmed such a relationship for creatinine level.

Effects of Transendocardial Delivery of Bone Marrow-Derived CD133+ Cells on Left Ventricle Perfusion and Function in Patients With Refractory Angina: Final Results of Randomized, Double-Blinded, Placebo-Controlled REGENT-VSEL Trial.

RATIONALE: New therapies for refractory angina are needed. OBJECTIVE: Assessment of transendocardial delivery of bone marrow CD133+ cells in patients with refractory angina. METHODS AND RESULTS: Randomized, double-blinded, placebo-controlled trial enrolled 31 patients with recurrent Canadian Cardiovascular Society II-IV angina, despite optimal medical therapy, ≥1 myocardial segment with inducible ischemia in Tc-99m SPECT who underwent bone marrow biopsy and were allocated to cells (n=16) or placebo (n=15). Primary end point was absolute change in myocardial ischemia by SPECT. Secondary end points were left ventricular function and volumes by magnetic resonance imaging and angina severity. After 4 months, there were no significant differences in extent of inducible ischemia between groups (summed difference score mean [±SD]: 2.60 [2.6] versus 3.63 [3.6], P=0.52; total perfusion deficit: 3.60 [3.6] versus 5.01 [4.3], P=0.32; absolute changes of summed difference score: -1.38 [5.2] versus -0.73 [1.9], P=0.65; and total perfusion deficit: -1.33 [3.3] versus -2.19 [6.6], P=0.65). There was a significant reduction of left ventricular volumes (end-systolic volume: -4.3 [11.3] versus 7.4 [11.8], P=0.02; end-diastolic volume: -9.1 [14.9] versus 7.4 [15.8], P=0.02) and no significant change of left ventricular ejection fraction in the cell group. There was no difference in number of patients showing improvement of ≥1 Canadian Cardiovascular Society class after 1 (41.7% versus 58.3%; P=0.68), 4 (50% versus 33.3%; P=0.63), 6 (70% versus 50.0%; P=0.42), and 12 months (55.6% versus 81.8%; P=0.33) and use of nitrates after 12 months. CONCLUSION: Transendocardial CD133+ cell therapy was safe. Study was underpowered to conclusively validate the efficacy, but it did not show a significant reduction of myocardial ischemia and angina versus placebo. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01660581.

In-hospital and long-term outcomes of percutaneous balloon aortic valvuloplasty with concomitant percutaneous coronary intervention in patients with severe aortic stenosis.

BACKGROUND: Severe aortic stenosis (AS) often coexists with significant coronary artery disease. OBJECTIVE: To evaluate procedural complications and long-term outcomes of patients with severe AS undergoing balloon aortic valvuloplasty (BAV) and percutaneous coronary intervention (PCI). METHODS: A total of 97 patients with severe AS underwent 104 BAVs as palliative procedure, bridge to definitive treatment, or before urgent non-cardiac surgery. Patients were followed-up for at least 12 months. RESULTS: Of the 97 patients, 34 (35.0%) underwent standalone BAV, 45 (46.4%) underwent BAV with coronary angiography, and 18 (18.6%) BAV with PCI. There were no differences in baseline characteristics and indications for BAV among the groups (P > 0.05). No higher risk of complications after BAV performed with concomitant coronary angiography/PCI was observed. Transcatheter aortic valve implantation was performed after BAV in 13 (13.4%) patients and surgical aortic valve replacement in three (3.1%) patients. In spite of no difference in in-hospital mortality (5.6% vs. 8.9%; P = 0.76), patients with BAV and concomitant PCI had lower long-term mortality than patients with BAV and concomitant coronary angiography (28.5% vs. 51.0%; P = 0.03). In multivariable Cox analysis adjusted for age, sex, and body mass index, the Society of Thoracic Surgeons Predicted Risk of Mortality score was identified as the only independent predictor of long-term mortality for all patients (HR: 1.09, 95%CI: 1.04-1.15, P = 0.0006). CONCLUSIONS: Concomitant PCI or coronary angiography performed with BAV may not increase the risk of major and vascular complications. Patients with BAV and concomitant PCI may have better survival than patients with BAV and concomitant coronary angiography.

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.

Impact of frailty on mortality after transcatheter aortic valve implantation.

BACKGROUND: We sought to investigate the relation between frailty indices and 12-month mortality after transcatheter aortic valve implantation (TAVI). METHODS: We included 101 consecutive patients with severe aortic stenosis who have undergone TAVI. Frailty indices according to Valve Academic Research Consortium-2 recommendations (5-m walk test [5MWT] and hand grip strength) as well as other available scales of frailty (Katz index, Elderly Mobility Scale [EMS], Canadian Study of Health and Aging [CSHA] scale, Identification of Seniors at Risk [ISAR] scale) were assessed at baseline. The primary endpoint was 12-month all-cause mortality. RESULTS: Twelve-month all-cause mortality was 17.8%. According to 5MWT, 17.8% were frail; hand grip test: 6.9%; Katz index: 17.8%; EMS: 7.9%; CSHA scale: 16.9%; and ISAR scale: 52.5%. Associations between frailty indices and 12-month all-cause mortality after TAVI were significant in Cox regression analysis (frail vs not frail, presented as hazard ratio[95%CI] adjusted for logistic EuroSCORE): for 5MWT, 72.38 (15.95-328.44); for EMS, 23.39 (6.89-79.34); for CSHA scale, 53.97 (14.67-198.53); for Katz index, 21.69 (6.89-68.25); for hand grip strength, 51.54 (12.98-204.74); and for ISAR scale, 15.94 (2.10-120.74). Similarly, such relationship was confirmed when 5MWT, EMS, and CSHA were used as continuous variables (hazard ratio [95%CI] adjusted for logistic EuroSCORE: for 5MWT per 1-second increase, 2.55 [1.94-3.37]; for EMS per 1-point decrease, 2.90 (1.99-4.21); and for CSHA per 1-point increase, 3.13 [2.17-4.53]). CONCLUSIONS: Our study confirmed a strong predictive ability of most of the proposed frailty indices for 12-month mortality after TAVI. For patients scheduled for TAVI, the use of frailty indices, which are easy and quick to assess on clinical basis but with strong performance, for example, 5MWT, EMS, or hand grip test, may be advocated.

Acute and long-term outcomes of percutaneous balloon aortic valvuloplasty for the treatment of severe aortic stenosis.

OBJECTIVES: This study aimed to evaluate the indications, short- and long-term outcomes of balloon aortic valvuloplasty (BAV) in patients with severe aortic stenosis (AS). METHODS: A cohort of 112 patients with AS underwent 114 BAV procedures between October 2012 and July 2015 in two Polish interventional cardiology centers. Clinical and echocardiographic data were prospectively collected within 1, 6, and 12 months follow-up. RESULTS: BAV was performed as a bridge to TAVI (51.8%), surgical aortic valve replacement (AVR, 5.4%), before urgent noncardiac surgery (8.0%), for symptom relief (33.0%) and cardiogenic shock (1.8%). Periprocedural, in-hospital, 1-, 6-, 12-month mortality were 2.7%; 8.9%; 8.9%; 16.9%; 22.3%, respectively. Serious periprocedural adverse events occurred in 18.8% of patients. After the procedure, mean aortic valve area (AVA) increased from 0.59 ± 0.18 to 0.82 ± 0.24 cm2 , mean peak aortic valve gradient (pAVG) decreased from 94.0 ± 27.6 to 65.4 ± 20.0 mm Hg, mean aortic gradient decreased from 58.0 ± 17.8 to 40.5 ± 14.6 mm Hg, P < 0.05 for all. Left ventricular ejection fraction (LVEF) increased from median (interquartile range) of 53.5 (30 - 64) to 60 (45 - 65)% after 1 month (P < 0.05). In patients with impaired left ventricle function (LVEF <40%), LVEF significantly improved (median increase of 16%) after 1 and 6 months (P < 0.05). At 12 months patients had higher AVA, pAVG, and LVEF as compared to baseline (P < 0.05). CONCLUSIONS: BAV is a useful procedure in high-risk AS patients, where achieved effects can be sufficient in bridging patients for TAVI/AVR. © 2016 Wiley Periodicals, Inc.

Association Between Blood Transfusions and 12-Month Mortality After Transcatheter Aortic Valve Implantation.

Blood transfusions are considered as an important predictor of adverse outcome in patients with severe aortic (AS) undergoing transcatheter aortic valve implantation (TAVI). We sought to investigate the association between blood transfusions and mortality after TAVI. We enrolled 101 consecutive patients with severe AS undergoing TAVI. Patients who required transfusion were defined as patients in whom at least one unit of packed red blood cells (PRBCs) was transfused in the perioperative period. Twelve-month outcomes were assessed based on Valve Academic Research Consortium definitions. A total of 28 (27.7%) patients required blood transfusion after TAVI. Baseline characteristics of the patients with and without a transfusion were similar. Median amount of PRBCs was 2 (interquartile range, 2-4). Twelvemonth all-cause mortality was higher in patients with than without a blood transfusion (39.3% versus 9.6%; P = 0.001). Importantly, the need for a blood transfusion after TAVI was an independent predictor of higher mortality rates after 12 months (hazard ratio (HR) 2.84 95%CI (1.06-7.63); P = 0.039; (HR for incomplete coronary revascularization 10.86, 95%CI 3.72-31.73; P < 0.001; HR for a history of stroke/TIA 3.93, 95%CI 1.39-11.07; P < 0.001). The duration of inhospital stay was longer in patients requiring transfusion (16.0 (14.0-22.0) versus 7.0 (7.0-11.5) days; P = 0.014). In conclusion, blood transfusions after TAVI were associated with higher mortality rates after 12 months, longer in-hospital stay, and were identified as an independent predictor of impaired clinical outcome.

Impact of Coronary Artery Disease Burden on 12-Month Mortality of Patients After Transcatheter Aortic Valve Implantation.

OBJECTIVES: The aim of the study was to compare 12-month mortality rate of patients with and without complete coronary revascularization before transcatheter aortic valve implantation (TAVI). BACKGROUND: There are limited data on the impact of coronary artery disease burden in patients with severe aortic stenosis undergoing TAVI. METHODS: One hundred and one consecutive patients undergoing TAVI were enrolled. Of them 16 (15.8%) had an incomplete coronary revascularization. The primary endpoint was 12-month all-cause mortality. RESULTS: Twelve-month all-cause mortality was higher in patients with incomplete coronary revascularization than in patients with complete coronary revascularization or without significant lesions (75.0% vs 7.1%; P < 0.001). Importantly, incomplete coronary revascularization was an independent predictor of higher mortality rate after 12 months (hazard ratio (HR) for incomplete coronary revascularization 10.86, 95% CI 3.72-31.73; P < 0.001; HR for a history of stroke/TIA 3.93, 95% confidence interval (CI) 1.39-11.07; P < 0.001; HR for blood transfusion 2.84 95% CI (1.06-7.63); P = 0.039). In 9 of 16 (56.3%) patients, incomplete revascularization was related to the presence of chronic total occlusions (CTO). Patients with CTO had an increased mortality rate after 12 months (55.6% vs 14.1%; P = 0.008) as compared to patients without the CTO. CONCLUSIONS: Incomplete coronary revascularization and a history of stroke or TIA may be independent predictors of all-cause mortality in patients undergoing TAVI. However, further studies are recommended to confirm the results, especially in terms of the impact of CTO presence on long-term mortality after TAVI.

Radial artery spasms - angiographic morphology, risk factors and management.

Introduction: Radial artery is the preferred access for coronary interventions. However, the procedure is sometimes interrupted by a spasm which causes pain, prolongs the procedure, and can force the access crossover. Aim: To observe factors contributing to a symptomatic radial artery spasm. Material and methods: In this prospective study, we present results of 103 consecutive patients regarding radial artery spasm and angiographic image of the punctured artery. Angiography of the radial artery was performed in 70 (68.0%) patients. Potential risk factors for radial artery spasm were evaluated. Results: The overall incidence of the radial artery spasm was high - 25 (24.3%). Signs of spasm were present in 37.1% of radial artery angiographies before the procedure and 60.1% after, however, it did not always indicate a symptomatic spasm. Risk factors related to radial artery spasm included female sex (OR = 2.94, p = 0.02), failure of the first puncture attempt (OR = 3.12, p = 0.014) and use of non-hydrophilic sheath (OR = 9.56, p = 0.036). Radial artery narrowing at the tip of the sheath was also a risk factor for spasm (p = 0.022). No spasms were observed after hydrophilic sheath application (n = 13). The administration of a radial cocktail was not observed to significantly decrease the spasm odds. Conclusions: Risk factors for radial artery spasm include female sex and multiple puncture attempts. Hydrophilic sheath coating protects against radial artery spasm. Overall signs of a spasm in the angiography are common and do not imply a symptomatic spasm, which can be predicted by a tight narrowing at the tip of the sheath.

A clinical evaluation of the ProNOVA XR polymer-free sirolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions (EURONOVA XR I study).

AIMS: Evaluation of safety and efficacy of ProNOVA XR, a new generation of polymer-free sirolimus eluting stents (SES), utilizing a pharmaceutical excipient for timed release of sirolimus from the XR platform. METHODS AND RESULTS: Safety and efficacy of ProNOVA XR coronary stent system was examined in EURONOVA prospective, single arm, multi-center registry of 50 patients with de novo native coronary lesions up to 28 mm in length in arteries between 2.25 and 4 mm. At 6-month, in-stent late lumen loss by QCA was 0.45 ± 0.41 mm and in-stent neointimal volume obstruction in the IVUS sub-study was 14 ± 11%. One-year clinical follow-up revealed a favorable safety profile, with 2% of in-hospital MACE and 6.4% of MACE from hospital discharge up to 12 months (including 1 cardiac death >30 days after stent implantation and 2 TLRs). According to the ARC definition, there was no definite or probable stent thrombosis and 1 possible stent thrombosis (2%) up to 12 months of clinical follow-up. CONCLUSIONS: In this preliminary evaluation, ProNOVA XR polymer-free sirolimus eluting stent system appeared safe with an early promise of adequate effectiveness in the treatment of de novo coronary lesions in up to 12 months of clinical, angiographic and IVUS follow-up.

Is single-catheter technique for coronary angiography an optimal tool for beginners in interventional cardiology?-randomized controlled study TRACT 2: Transradial Coronary Angiography Trial 2.

Background: Transradial coronary angiography can be performed using a dual-catheter technique (DCT) or single-catheter technique (SCT). The current study aimed to compare DxTerity SCT Ultra and the Trapease curve SCT catheters with DCT catheters in procedures performed by young, less experienced, interventional cardiologists. Methods: For this prospective, single-blinded, randomized study 107 were enrolled and assigned to 1 of 3 groups. They underwent planned coronary angiography at the Second Department of Cardiology Jagiellonian University in Kraków. In groups 1 (n=37) and 2 (n=35), DxTerity SCT Ultra catheters and the Trapease curve were used, respectively. In control group 3 (n=35), standard DCT Judkins catheters were applied. One patient was excluded from group 2, bringing the total number of cases analysed to 106. The study endpoints comprised the percentage of optimal stability, proper ostial artery engagement, a good quality angiogram, the duration of each procedure stage, the amount of contrast and the radiation dose. Results: The highest percentage of optimal stability was observed in group 1 for the right coronary artery (RCA): 94%, and in group 3, for the left coronary artery (LCA): 85%. The necessity to change the catheter was most common in group 2. Group 1 was characterised by a shorter total procedural time. The contrast volume was higher in group 2, while there were no differences in radiation dose. Conclusions: SCT is at least as adequate as DCT for young cardiologists. SCT was associated with lower necessity of catheter exchange during RCA visualization. The DxTerity Ultra curve catheter allows shortening the total procedure time.

Safety and efficacy of repeated balloon aortic valvuloplasty in patients with symptomatic severe aortic stenosis.

BACKGROUND: Long-term outcomes of balloon aortic valvuloplasty (BAV) in patients with severe symptomatic aortic stenosis (AS) are poor, and this procedure needs to be repeated in selected cases. AIMS: We aimed to investigate the safety and efficacy of repeated BAV (reBAV). METHODS: We included consecutive patients who underwent reBAV in three Polish centers between 2010 and 2019. Baseline clinical, echocardiographic, procedural, and outcome data were analyzed. RESULTS: Thirty-five patients (median age 81.5 years, 57.1% women) who underwent reBAV were enrolled. In 42.9% of the patients, index BAV was considered a palliative treatment, and in 54.3% a bridge to definitive treatment. Index BAV decreased peak aortic valve gradient (pAVG) from a median of 78.0 mm Hg to 46.0 mm Hg (P <0.001). After a mean of 255.8 days, reBAV was performed. In most cases (71.4%), the reason for reBAV was the worsening of heart failure symptoms and in 54.3% of patients, reBAV was still considered a palliative option. A decrease in pAVG max from a median of 73.0 mm Hg to 45.0 mm Hg (P <0.001), comparable to index BAV, was observed. The frequency of complications were numerically higher for repeated procedures. During the median (IQR) follow-up of 403.0 (152.0-787.0) days from the index procedure, 80.0% of the patients died. CONCLUSIONS: Acute hemodynamic results of reBAV are comparable to those achieved during index BAV. However, reBAV may carry an increased risk of complications. Moreover, mortality is high due to unfavorable risk profiles or delays in receiving definitive therapy.

The impact of sex on in-hospital and long-term mortality rates in patients undergoing surgical aortic valve replacement: The SAVR and SEX study.

BACKGROUND: Surgical aortic valve replacement (SAVR) is among the most commonly performed valvular surgeries. Despite many previous studies conducted in this setting, the impact of sex on outcomes in patients undergoing SAVR is still unclear. AIMS: This study aimed to define sex differences in short- and long-term mortality in patients undergoing SAVR. METHODS: We analyzed retrospectively all the patients undergoing isolated SAVR from January 2006 to March 2020 in the Department of Cardiovascular Surgery and Transplantology in John Paul II Hospital in Kraków. The primary endpoint was in-hospital and long-term mortality. Secondary endpoints included the duration of hospital stay and perioperative complications. Groups of men and women were compared with regard to the prosthesis type. Propensity score matching was performed to adjust for differences in baseline characteristics. RESULTS: A total number of 4 510 patients undergoing isolated surgical SAVR were analyzed. A follow- up median (interquartile range [IQR]) was 2120 (1000-3452) days. Females made up 41.55% of the cohort and were older, displayed more non-cardiac comorbidities, and faced a higher operative risk. In both sexes, bioprostheses were more often applied (55.5% vs. 44.5%; P <0.0001). In univariable analysis, sex was not linked to in-hospital mortality (3.7% vs. 3%; P = 0.15) and late mortality rates (23.37% vs. 23.52 %; P = 0.9). Upon adjustment for baseline characteristics (propensity score matching analysis) and considering 5-year survival, a long-term prognosis turned out to be better in women (86.8%) compared to men (82.7%, P = 0.03). CONCLUSIONS: A key finding from this study suggests that female sex was not associated with higher in-hospital and late mortality rates compared to men. Further studies are needed to confirm longterm benefits in women undergoing SAVR.

Multicenter registry of Impella-assisted high-risk percutaneous coronary interventions and cardiogenic shock in Poland (IMPELLA-PL).

BACKGROUND: Impella is a percutaneous mechanical circulatory support device for treatment of cardiogenic shock (CS) and high-risk percutaneous coronary interventions (HR-PCIs). IMPELLA-PL is a national retrospective registry of Impella-treated CS and HR-PCI patients in 20 Polish interventional cardiological centers, conducted from January 2014 until December 2021. AIMS: We aimed to determine the efficacy and safety of Impella using real-world data from IMPELLA-PL and compare these with other registries. METHODS: IMPELLA-PL data were analyzed to determine primary endpoints: in-hospital mortality and rates of mortality and major adverse cardiovascular and cerebrovascular events (MACCE) at 12 months post-discharge. RESULTS: Of 308 patients, 18% had CS and 82% underwent HR-PCI. In-hospital mortality rates were 76.4% and 8.3% in the CS and HR-PCI groups, respectively. The 12-month mortality rates were 80.0% and 18.2%, and post-discharge MACCE rates were 9.1% and 22.5%, respectively. Any access site bleeding occurred in 30.9% of CS patients and 14.6% of HR-PCI patients, limb ischemia in 12.7% and 2.4%, and hemolysis in 10.9% and 1.6%, respectively. CONCLUSIONS: Impella is safe and effective during HR-PCIs, in accordance with previous registry analyses. The risk profile and mortality in CS patients were higher than in other registries, and the potential benefits of Impella in CS require investigation.

Quantitative flow ratio for evaluation of borderline coronary lesions in patients with severe aortic stenosis.

INTRODUCTION AND OBJECTIVES: Quantitative flow ratio (QFR) is a novel noninvasive method for evaluating coronary physiology. However, data on the QFR in patients with aortic stenosis (AS) and coronary artery disease are scarce. Thus, we compared the diagnostic performance of the QFR with that of the resting distal to aortic coronary pressure (Pd/Pa) ratio, fractional flow reserve (FFR), and instantaneous wave-free ratio (iFR), as well as angiographic indices. METHODS: A total of 221 AS patients with 416 vessels undergoing FFR/iFR measurements were enrolled in the study. RESULTS: The mean percent diameter stenosis (%DS) was 58.6%±13.4% and the mean Pd/Pa ratio, FFR, iFR, and QFR were 0.95±0.03, 0.85±0.07, 0.90±0.04, and 0.84±0.07, respectively. A FFR ≤ 0.80 was noted in 26.0% of interrogated vessels, as well as an iFR ≤ 0.89 in 33.2% and QFR ≤ 0.80 in 31.7%. The QFR had better agreement with FFR (intraclass correlation coefficient [ICC], 0.96; 95% confidence interval [95%CI], 0.95-0.96) than with the iFR (ICC, 0.79; 95%CI, 0.75-0.82) and Pd/Pa ratio (ICC, 0.52; 95%CI, 0.44-0.58). In addition, the QFR showed better diagnostic accuracy (98.6% vs 94.2%; P <.001) and discriminant function (area under the curve=0.996 vs 0.988; P <.001) when the iFR was used as the reference instead of FFR. CONCLUSIONS: In patients with AS, the QFR has good agreement with both FFR and iFR. However, the agreement appears to be even better when the iFR is used as the reference, presumably due to the complex nature of the coronary physiology in the assessment of coronary artery disease in patients with severe AS.

Clinical outcomes in patients undergoing complex, high-risk percutaneous coronary intervention and haemodynamic support with intra-aortic balloon versus Impella pump: Real-life single-centre preliminary results.

BACKGROUND: Patients and mechanical circulatory support assortment, as well as periprocedural and post-procedural clinical outcomes in complex high-risk percutaneous coronary interventions (PCIs) underpinned by percutaneous left ventricular assist devices (pLVAD) are the subject of debate. AIMS: The study aimed to identify differences between patients qualified for complex high-risk PCIs with an intra-aortic balloon pump (IABP) or Impella pump support and to compare peri- and post-procedural clinical outcomes. METHODS: The presented analysis is a single-center study, which comprised consecutive patients undergoing complex high-risk PCIs performed with the pLVAD, either IABP or Impella. Patients included in the current analysis were recruited between January 2018 and December 2021. There were 28 (56%) patients in the Impella group and 22 (44%) in the IABP group. The primary endpoints included overall mortality and major adverse cardiovascular events (MACE) such as all-cause mortality, myocardial infarction, revascularization, and cerebrovascular events. RESULTS: Patients from the IABP group were significantly older, had higher left ventricular ejection fraction (LVEF), and less frequent history of PCI, while the in-hospital risk of death assessed by EuroSCORE II remained similar in the Impella and IABP groups (median interquartile range [IQR] 2.8 [2-3.8] vs. 2.5 [1.8-5.2]; P = 0.73). Patients undergoing complex high-risk PCIs with pLVAD support presented similar results during the follow-up, assessed by log-rank estimates in terms of MACE (P = 0.41) and mortality rate (P = 0.65). CONCLUSIONS: The use of pLVAD devices in patients undergoing complex high-risk PCIs, with reduced left ventricular ejection fraction, is a promising treatment option for patients disqualified from surgery by cardiac surgeons.

Impact of diabetes mellitus on the diagnostic performance of fractional flow reserve in patients with severe aortic stenosis.

BACKGROUND: The validity of functional assessment of coronary artery disease with fractional flow reserve (FFR) and/or instantaneous wave-free ratio (iFR) in patients with severe aortic stenosis (AS) might be affected by AS per se and other factors, including diabetes mellitus. AIMS: We aimed to evaluate the impact of diabetic status on FFR performance in severe AS. METHODS: The functional significance of 416 stenoses of intermediate angiographic severity in 221 patients with severe AS was assessed with iFR and FFR. Patients treated with insulin or oral hypoglycemic agents were classified as diabetic patients. RESULTS: Of 221 enrolled patients, 68 (32.1%) patients were diabetic. A total of 128 (30.8%) lesions in patients with and 288 in patients without diabetes mellitus were assessed. The mean (SD) FFR was 0.85 (0.07), and iFR was 0.90 (0.04) with no difference between nondiabetic and diabetic patients. Good agreement between iFR and FFR was confirmed for non-diabetic (ICC, 0.83 [95% confidence interval, CI, 0.79-0.86]) and diabetic (ICC, 0.82 [95% CI, 0.76-0.87]) patients. Among patients without diabetes mellitus, the optimal cutoff value for FFR to detect iFR ≤0.89 was 0.81 with sensitivity and specificity of 96.6% and 100.0%. The optimal cutoff value for FFR to detect iFR ≤0.89 for diabetic patients was 0.83 with sensitivity and specificity of 98.0% and 100.0%. CONCLUSIONS: In patients with severe AS, FFR correlates well with iFR. However, the optimal threshold for FFR to identify significant ischemia (iFR ≤0.89) in those patients may differ from the standard threshold of FFR ≤0.80 and might be affected by the diabetic status.

Frailty as a Predictor of In-Hospital Outcome in Patients with Myocardial Infarction.

(1) Background: Frailty is a condition associated with aging, co-morbidity, and disability. We aimed to investigate the relationship between frailty and in-hospital outcome in patients with myocardial infarction (MI), including the occurrence of delirium, hospital-acquired pneumonia (HAP), and length of hospital stay. (2) Methods: We analyzed 55 patients ≥ 75 years old with ST-elevation and non-ST-elevation MI. Assessment with Abbreviated Mental Test Score (AMTS), Activity of Daily Living (ADL), Instrumental Activity of Daily Living (IADL) and Clinical Frailty Scale (CFS) was performed. (3) Results: In ROC analysis, IADL and CFS presented good predictive values for the occurrence of delirium (AUC = 0.81, p = 0.023, and AUC = 0.86, p = 0.009, respectively). For predicting HAP, only AMTS showed a significant value (AUC = 0.69, p = 0.036). In regression analyses, all tests presented significant predictive values for delirium. For predicting HAP, only IADL and CFS presented significant values (in an analysis adjusted for age, gender and type of MI). Frail patients (≥5 points in CFS) had longer hospital stays (10 days IQR: 8-17 vs. 8 days IQR: 7-10; p = 0.03). (4) Conclusions: While recognizing the limitations of our study associated with the relatively low sample size, we believe that our analysis shows that frailty is a predictor of poorer in-hospital outcomes in patients with MI, including higher rates of delirium, HAP and longer hospital stay.

Prognostic Factors in Patients with Sudden Cardiac Arrest and Acute Myocardial Infarction Undergoing Percutaneous Interventions with the LUCAS-2 System for Mechanical Cardiopulmonary Resuscitation.

Sudden cardiac arrest (SCA) is one of the most perilous complications of acute myocardial infarction (AMI). For years, the return of spontaneous circulation (ROSC) has had to be achieved before the patient could be treated at the catheterization laboratory, as simultaneous manual chest compression and angiography were mutually exclusive. Mechanical chest compression devices enabled simultaneous resuscitation and invasive percutaneous procedures. The aim was to characterize the poorer responders that would allow one to predict the positive outcome of such a treatment. We retrospectively analyzed the medical charts of 94 patients with SCA due to AMI, who underwent mechanical cardiopulmonary resuscitation during angiography. In total, 48 patients, 8 (17%) of which survived the event, were included in the final analysis, which revealed that 83% of the survivors had mild to moderate hyperkalemia (potassium 5.0−6.0 mmol/L), in comparison to 15% of non-survivors (p = 0.002). In the age- and sex-adjusted model, patients with serum potassium > 5.0 mmol/L had 4.61-times higher odds of survival until discharge from the hospital (95% CI: 1.41−15.05, p = 0.01). Using the highest Youden index, we identified the potassium concentration of 5.1 mmol/L to be the optimal cut-off value for prediction of survival until hospital discharge (83.3% sensitivity and 87.9% specificity). The practical implications of these findings are that patients with potassium levels between 5.0 and 6.0 mmol/L may actually benefit most from percutaneous coronary interventions with ongoing mechanical chest compressions and that they do not need immediate correction for this electrolyte abnormality.