TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and multivessel or advanced coronary disease: The transcatheter valve and vessels trial (TCW trial): Design and rationale.

BACKGROUND: Patients with severe aortic stenosis (AS) frequently present with concomitant obstructive coronary artery disease (CAD). In those, current guidelines recommend combined coronary artery bypass grafting (CABG) and surgical aortic valve replacement (SAVR) as the preferred treatment option, although this surgical approach is associated with a high rate of clinical events. Combined transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) with or without FFR have evolved as a valid alternative for cardiac surgery in patients with AS and multivessel or advanced CAD. To date, no dedicated trial has prospectively evaluated the outcomes of a percutaneous versus surgical treatment for patients with both severe AS and CAD. AIMS: To investigate whether fractional-flow reserve (FFR)-guided PCI and TAVI is noninferior to combined CABG and SAVR for the treatment of severe AS and multivessel or advanced CAD. METHODS: The Transcatheter Valve and Vessels (TCW) trial (clinicaltrial.gov: NCT03424941) is a prospective, randomized, controlled, open label, international trial. Patients ≥ 70 years with severe AS and multivessel (≥ 2 vessels) or advanced CAD, deemed feasible by the heart team for both; a full percutaneous or surgical treatment, will be randomised in a 1:1 fashion to either FFR-guided PCI followed by TAVI (intervention arm) vs. CABG and SAVR (control arm). The primary endpoint is a patient-oriented composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve reintervention, and life threatening or disabling bleeding at 1 year. The TCW trial is powered for noninferiority, and if met, superiority will be tested. Assuming a primary endpoint rate of 30% in the CABG-SAVR arm, with a significance level α of 5%, a noninferiority limit delta of 15% and a loss to follow-up of 2%, a total of 328 patients are needed to obtain a power of 90%. The primary endpoint analysis is performed on an intention-to-treat basis. SUMMARY: The TCW Trial is the first prospective randomized trial that will study if a less invasive percutaneous treatment for severe AS and concomitant advanced CAD (i.e., FFR-guided PCI-TAVI) is noninferior to the guidelines recommended approach (CABG-SAVR).

Percutaneous transaxillary approach through the first segment of the axillary artery for the Impella-supported PCI Versus TAVR.

Percutaneous transaxillary approach (PTAX) through the first segment of the axillary artery is not widely recognized as a safe method. Furthermore, PTAX has never been directly compared between Impella-supported percutaneous coronary interventions (Impella-PCI) and transcatheter aortic valve replacement (TAVR). This study evaluated the feasibility and safety of PTAX through the first axillary segment in Impella-PCI versus TAVR. In cases where standard imaging guidance was insufficient, a technique involving puncturing the axillary artery "on-the-balloon" was employed. The endpoints were bleeding and vascular complications, as defined by BARC and VARC-3 criteria. PTAX was successfully performed in all 46 attempted cases: 23 for Impella-PCI and 23 for TAVR. Strict adherence to BARC and VARC-3 criteria led to the frequent identification of major bleeding (57%) and a moderately frequent diagnosis of vascular complications (17%). These incidences were primarily based on post-procedural hemoglobin reduction (> 3 g/dl) but not overt bleeding. The Impella group exhibited a higher rate of BARC 3b bleeding due to a greater hemoglobin decline resulting from the prolonged implant duration and PCI itself. Left axillary access was linked to smaller blood loss. Bleeding and vascular complications, as per BARC and VARC-3 definitions, did not affect short-term prognosis, with only 3 Impella patients succumbing to heart failure unrelated to the procedures during one-month follow-up period.

Procedural success in transaxillary transcatheter aortic valve implantation according to type of transcatheter heart valve: results from the multicenter TAXI registry.

BACKGROUND: Transaxillary (TAx) transcatheter aortic valve implantation (TAVI) is a preferred alternative access in patients ineligible for transfemoral TAVI. AIMS: This study used the Trans-AXillary Intervention (TAXI) registry to compare procedural success according to different types of transcatheter heart valves (THV). METHODS: For the TAXI registry anonymized data of patients treated with TAx-TAVI were collected from 18 centers. Acute procedural, early and 1-month clinical outcomes were adjudicated in accordance with standardized VARC-3 definitions. RESULTS: From 432 patients, 368 patients (85.3%, SE group) received self-expanding (SE) THV and 64 patients (14.8%, BE group) received balloon-expandable (BE) THV. Imaging revealed lower axillary artery diameters in the SE group (max/min diameter in mm: 8.4/6.6 vs 9.4/6.8 mm; p < 0.001/p = 0.04) but a higher proportion of axillary tortuosity in BE group (62/368, 23.6% vs 26/64, 42.6%; p = 0.004) with steeper aorta-left ventricle (LV) inflow (55° vs 51°; p = 0.002) and left ventricular outflow tract (LVOT)-LV inflow angles (40.0° vs 24.5°; 0.002). TAx-TAVI was more often conducted by right sided axillary artery in the BE group (33/368, 9.0% vs 17/64, 26.6%; p < 0.001). Device success was higher in the SE group (317/368, 86.1% vs 44/64, 68.8%, p = 0.0015). In logistic regression analysis, BE THV were a risk factor for vascular complications and axillary stent implantation. CONCLUSIONS: Both, SE and BE THV can be safely used in TAx-TAVI. However, SE THV were more often used and were associated with a higher rate of device success. While SE THV were associated with lower rates of vascular complications, BE THV were more often used in cases with challenging anatomical circumstances.

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.

Roadmap towards an institutional Impella programme for high-risk coronary interventions.

Coronary artery disease (CAD) and its complications remain the main cause of morbidity and mortality worldwide. Patients with extensive CAD and multiple comorbidities who require complex, high-risk percutaneous coronary intervention (HR-PCI) are at risk of haemodynamic instability and may require short-term mechanical circulatory support (MCS) during the procedure to maintain sufficient perfusion and prevent ischaemia. Impella is a microaxial continuous blood flow pump used for percutaneous support of the left ventricle in patients undergoing HR-PCI. Data from randomized controlled trials and registries suggested an advantage for Impella devices in patients undergoing HR-PCI, compared with other types of MCS. As a thorough understanding of the benefits and drawbacks of the Impella technology is crucial for patient outcomes, we provide a technological overview of Impella and share our experiences gathered during the implementation of institutional Impella programmes in Poland as a roadmap of selection and periprocedural care for patients treated with Impella in the setting of HR-PCI. We propose 10 steps for implementation of an institutional Impella programme for HR-PCI, including (i) dedicated staff training; (ii) standard operating procedure and troubleshooting algorithms prior to the first intervention; (iii) patient selection by the multidisciplinary Heart Team; (iv) patient preparation using multimodality imaging; (v) procedure planning in terms of large-bore access, equipment, and complete revascularization; (vi) starting with HR-PCI support; (vii) starting with femoral artery access in a patient without extensive peripheral artery disease; (viii) multidisciplinary care after the procedure; (ix) haemodynamic and laboratory monitoring to ensure immediate diagnosis of access-site complications, bleeding, haemolysis, acute kidney injury, and infections; and (x) careful revision of every HR-PCI case with the team.

Clinical manifestations of cancer in patients with acute pulmonary embolism.

BACKGROUND: Neoplasmatic disease increases the risk of acute pulmonary embolism (APE) by different pathophysiological mechanisms that favor thrombosis in patients with cancer. Recently, the role of cancer (active and occult) in the prevalence of venous thromboembolism has been discussed more thoroughly in the subject literature. MATERIAL: Medical records of 366 consecutive patients with a diagnosis of APE (aged: mean = 65.0 ±â€Š16.6, median = 68, range = 19-94; men = 41%/women = 59%) were collected with a wide range of demographic data, medical history of coexisting diseases, computer examination, and laboratory tests. METHODS: The APE patients were analyzed in two groups: negative cancer cases (83%), i.e. without concomitant active malignancy or a history of cancer, and positive ones (17%), i.e. those hospitalized with concomitant active cancer disease or a history of cancer within the past 5 years. RESULTS: Based on the application of the Student's t -test for independent samples and the χ2 test of independence, a statistically significant difference ( P  < 0.05) between cancer (-) and cancer(+) groups of patients was calculated for the following selected risk factors: BMI, smoking status, hemoglobin, hematocrit, red blood cell, urea, glomerular filtration rate, high-sensitivity troponin T, C-reactive protein (CRP), D-dimer, and NT-proBNP. Using univariate Cox regression and a discrete-time hazard model, the estimated hazard ratios and odds ratios, respectively, for the risk of an earlier death from cancer as well as for a secondary APE episode in APE patients with malignancy are more than three times higher than in cancer-free patients and they are statistically significant ( P  < 0.05). Moreover, the modeled discrete-time hazard curves show a constant excess risk of death and a secondary APE episode in patients diagnosed with malignancy over the period of observation. CONCLUSION: Cancer and APE seem to go 'hand in hand'. Attention should be paid to many factors, primarily clinical, differentiating patients with cancer from those with an APE incident. The patients with cancer after a primary APE should receive anticoagulants to prevent a secondary APE episode and to reduce the risk of mortality.

Heart Rate Variability and Cardiorespiratory Fitness in Youth Populations: The Impact of Heart Rate on Data Analysis.

The positive association between heart rate variability and cardiorespiratory fitness in youth populations is unclear. In this regard, several methodological aspects related to heart rate variability analysis could partially explain the disagreement between studies. To the best of the authors' knowledge, the influence of the heart rate on data analysis is unclear. In the present short communication, we discuss the impact of the heart rate on the associations between heart rate variability and cardiorespiratory fitness in youth. In addition, we proposed some aspects that should be considered for statistical analyses when the relationship between heart rate variability and cardiorespiratory fitness is studied. Finally, we should acknowledge that these recommendations may be applicable for other health-related outcomes different than cardiorespiratory fitness (e.g., inflammatory markers, cognition, cardiovascular disease status).

Valve-in-valve transcatheter transfemoral mitral valve implantation (ViV-TMVI): Characteristics and early results from nationwide registry.

BACKGROUND: Valve-in-valve transcatheter transfemoral mitral valve implantation (ViV-TMVI) is an emerging treatment alternative to reoperation in high surgical risk patients with a failed mitral bioprostheses. AIM: To describe characteristics and evaluate 30-day outcomes of ViV-TMVI in the Polish population. METHODS: Nationwide registry was initiated to collect data of all patients with failed mitral bioprosthesis undergoing ViV-TMVI in Poland. This study presents 30-days clinical and echocardiographic follow-up. RESULTS: Overall, 27 ViV-TMVI were performed in 8 centers until May 2022 (85% since 2020). Mean (standard deviation [SD]) age was 73 (11.6) years with the median (interquartile range [IQR]) STS score of 5.3% (4.3%-14.3%). Mean (SD) time between surgical implantation and ViV-TMVI was 8.2 (3.2) years. Failed Hancock II (29%) and Perimount Magna (22%) were most frequently treated. Mechanisms of failure were equally often pure mitral regurgitation or stenosis (both 37%) with mixed etiology in 26%. Balloon-expandable Sapien 3/Ultra were used in all but 1 patient. Technical success was 96.3% (1 patient required additional prosthesis). Mean (SD) transvalvular mitral gradient reached 6.7 (2.2) mm Hg and mitral valve area was 1.8 (0.4) cm². None of the patients had moderate or severe mitral regurgitation with only 14.8% graded as mild. In 92.6% device success (2 patients had mean gradient ≥10 mm Hg) and in 85.6% procedural success was present. There were no deaths, cerebrovascular events or need for mitral valve surgery during 30-day follow-up. CONCLUSIONS: In short-term observation ViV-TMVI is safe and effective alternative for patients with failed mitral bioprosthesis at high surgical risk of re-operation. Longer observations on larger sample are warranted.

Nationwide experience with transcarotid transcatheter aortic valve implantation: Insights from the POL-CAROTID registry.

BACKGROUND: The carotid artery is an alternative access route for transcatheter aortic valve implantation (TAVI), especially useful in patients unsuitable for traditional access routes including transfemoral (TF), subclavian, transapical, and aortic. AIMS: To investigate the feasibility and safety of transcarotid (TC) access for TAVI in comparison to the TF approach in a multicenter setting. METHODS: A total of 41 patients, treated between December 2014 and December 2018, were retrospectively reported to the Polish Registry of Common Carotid Artery Access for TAVI (POL-CAROTID). The median follow-up time was 619 (365-944) days, and Valve Academic Research Consortium-2 (VARC-2) definitions were applied. Clinical outcomes were compared with 41 propensity-matched TF-TAVI patients. RESULTS: The mean (standard deviation [SD]) patients' age was 78.0 (7.2) years, and 29 patients (70.7%) were men. Prohibitive iliofemoral anatomy and/or obesity (46.3%) and/or the presence of a stent graft in the abdominal aorta (31.7%) were the most common indications for TC-TAVI. Device success for TC-TAVI was comparable with the matched TF-TAVI group (90.2% vs. 95.3%, respectively, P = 0.396), and no periprocedural mortality was observed. Moreover, early safety was similar between the two groups (92.7% vs. 95.3%, respectively, log-rank P = 0.658) with only 1 case of non-disabling stroke during the first month after TC-TAVI. Consequently, no cerebrovascular events were observed in the mid-term, and the clinical efficacy of TC-TAVI corresponded well with TF-TAVI (90.2% vs. 92.7%, respectively, log-rank P = 0.716). A total of 4 (9.8%) deaths were noted in the TC-TAVI cohort in comparison to 3 (7.3%) in the TF-TAVI group. CONCLUSIONS: The results of the study indicated that the first cohort of Polish patients with implantations of second-generation transcarotid transcatheter heart valves had a similar prognosis to TF-TAVI with regard to safety and feasibility. TC access may be considered an optimal alternative for patients in whom the TF approach is precluded.

Associations between different heart rate variability ratios and cardiometabolic risk factors in young adults.

AIMS: To study the association of two different heart rate variability (HRV) ratios with cardiovascular disease (CVD) risk factors in young adults. METHOD: A total of 132 participants (89 women) were included in this cross-sectional study. We assessed their HRV and computed the low frequency-to-high frequency ratio (LF/HF) and, from the Poincaré plot, the ratio of the inverse of the longitudinal (SD2) to the transversal (SD1) axes ([1000/SD2]/SD1; sympathetic: parasympathetic [S:PS] ratio). From blood samples, we determined total cholesterol, high-density (HDL-C) and low-density lipoprotein-cholesterol, triglycerides, glucose, insulin, and the homeostatic model assessment of insulin resistance (HOMA) index. Multiple linear regression models were adjusted for age. RESULTS: Both, the LF/HF and the S:PS ratios, were positively associated with glucose metabolism markers (glucose, insulin, HOMA index), and negatively associated with HDL-C in women but not in men. CONCLUSION: We showed that the LF/HF and the S:PS are associated similarly with CVD risk factors in young women.

Associations between heart rate variability and maximal fat oxidation in two different cohorts of healthy sedentary adults.

BACKGROUND AND AIMS: Resting heart rate variability (HRV) and maximal fat oxidation (MFO) during exercise are both considered as a noninvasive biomarkers for early detection of cardiovascular risk factors. Thus, this study aimed to analyze the relationship between resting HRV parameters and MFO during exercise, and the intensity of exercise that elicit MFO (Fatmax) in healthy sedentary adults. METHODS AND RESULTS: A total of 103 healthy young adults (22.2 ± 2.3 years old, 67% female; from the ACTIBATE cohort) and 67 healthy middle-aged adults (53.1 ± 5.0 years old, 52% female; from the FIT-AGEING cohort) were included in this cross-sectional study. HRV was assessed using a Polar RS800CX heart rate monitor, while MFO and Fatmax were determined during a graded exercise treadmill test using indirect calorimetry. No significant associations were observed for healthy young adults (standardized ß coefficients ranged from -0.063 to 0.094, and all P ≥ 0.347) and for middle-aged adults (standardized ß coefficients ranged from -0.234 to 0.090, and all P ≥ 0.056). Nevertheless, only a weak association was observed between one HRV parameter in time-domain (the percentage of R-R intervals that shows a difference higher than 50 ms [pNN50]) and MFO in the cohort of middle-aged adults (ß coefficient = -0.279, and P = 0.033). CONCLUSION: The results of this study suggest that resting HRV parameters are not associated with MFO and Fatmax during exercise in two independent cohorts of healthy sedentary young and middle-aged adults, respectively.

Percutaneous vs. surgical axillary access for transcatheter aortic valve implantation: the TAXI registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established management strategy for severe aortic valve stenosis. Percutaneous axillary approach for TAVI holds the promise of improving safety without jeopardizing effectiveness in comparison to surgical access. We aimed at appraising the comparative effectiveness of percutaneous vs. surgical axillary approaches for TAVI. METHODS: We performed an international retrospective observational study using de-identified details on baseline, procedural, and 1-month follow-up features. Valve Academic Research Consortium (VARC)-3 criteria were applied throughout. Outcomes of interest were clinical events up to 1 month of follow-up, compared with unadjusted and propensity score-adjusted analyses. RESULTS: A total of 432 patients were included, 189 (43.8%) receiving surgical access, and 243 (56.2%) undergoing percutaneous access. Primary hemostasis failure was more common in the percutaneous group (13.2% vs. 4.2%, P<0.001), leading to more common use of covered stent implantation (13.2% vs. 3.7%, P<0.001). Irrespectively, percutaneous access was associated with shorter hospital stay (-2.6 days [95% confidence interval: -5.0; -0.1], P=0.038), a lower risk of major adverse events (a composite of death, myocardial infarction, stroke, type 3 bleeding, and major access-site related complication; odds ratio=0.44 [0.21; 0.95], P=0.036), major access-site non-vascular complications (odds ratio=0.21 [0.06; 0.77], P=0.018), and brachial plexus impairment (odds ratio=0.16 [0.03; 0.76], P=0.021), and shorter hospital stay (-2.6 days [-5.0; -0.1], P=0.038). CONCLUSIONS: Percutaneous axillary access provides similar or better results than surgical access in patients undergoing TAVI with absolute or relative contraindications to femoral access.