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).

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.

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.

Cardiovascular Risk Factors and Heart Rate Variability: Impact of the Level of the Threshold-Based Artefact Correction Used to Process the Heart Rate Variability Signal.

The associations between cardiovascular disease (CVD) risk factors and heart rate variability (HRV) have shown some inconsistencies. To examine the impact of the different Kubios threshold-based artefact correction levels on the associations between different CVD risk factors and a heart rate variability (HRV) score in three independent human cohorts. A total of 107 children with overweight/obesity, 132 young adults, and 73 middle-aged adults were included in the present study. Waist circumference and the HRV score were negatively associated using the medium and the strong Kubios filters in children (ß = -0.22 and - 0.24, P = 0.03 and 0.02 respectively) and the very strong Kubios filter in middle-aged adults (ß = -0.39, P = 0.01). HDL-C was positively associated with the HRV score across Kubios filters (ß ranged from 0.21 to 0.31, all P ≤ 0.04), while triglycerides were negatively associated with the HRV score using the very strong Kubios filter in young adults (ß = -0.22, P = 0.02). Glucose metabolism markers (glucose, insulin, and HOMA index) were inversely associated with the HRV score across Kubios filters in young adults (ß ranged from -0.29 to -0.22; all P ≤ 0.03). Importantly, most of these associations disappeared after including HR as a covariate, especially in children and young adults. It should be mandatory to report the Kubios filter used and to include the HR (as a confounder factor) to allow the comparability of the results across different studies.

Interaction between heart rate and heart rate variability.

Heart rate variability (HRV) is significantly associated with average heart rate (HR), therefore, HRV actually provides information on two quantities, that is, on HR and its variability. It is difficult to conclude which of these two plays a principal role in the HRV clinical value, or in other words, what is the HR contribution to the clinical significance of HRV. Moreover, the association between HRV and HR is both a physiological phenomenon and a mathematical one. The physiological HRV dependence on HR is determined by the autonomic nervous system activity, but the mathematical one is caused by the nonlinear relationship between RR interval and HR. By employing modification methods of the HRV and HR relationship, it is possible to investigate the HR contribution to the HRV clinical value. Recent studies have shown that the removal of the HR impact on HRV makes HRV more predictive for noncardiac death, however, the enhancement of this impact causes HRV to be a better predictor of cardiovascular mortality. Thus, HR seems to constitute a cardiovascular factor of the HRV predictive ability. HR also influences the reproducibility of HRV, therefore, HR changes should be considered when one compares HRV measurements in a given patient. This review summarizes methodological aspects of investigations of the HRV and HR interaction as well as latest observations concerning its clinical utility. The issues discussed in this article should also refer to any other heart rate dynamics analysis which indices are significantly associated with HR.

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.

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).

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.

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.

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.

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.

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.

Vasospastic angina with J-wave pattern and polymorphic ventricular tachycardia effectively treated with quinidine.

BACKGROUND: Myocardial ischemia during coronary spasm may generate malignant ventricular arrhythmias. The J-wave pattern was suggested to be a marker of a disorder associated with life-threatening arrhythmias. RESULTS: We report the case of a patient with vasospastic angina and J-wave pattern in inferior and lateral leads associated with polymorphic ventricular tachycardia which was effectively treated only with quinidine-vasodilating drugs were not able to prevent the arrhythmia although they were effective in preventing ischemic events. CONCLUSION: The J-wave pattern in inferolateral leads may be a sign of electrical vulnerability to lethal ventricular arrhythmia in patients suffering from vasospastic angina--quinidine can effectively prevent such arrhythmias in these patients.

Heart rate rather than heart rate variability is better associated with cardiorespiratory fitness in adults.

This study aimed to examine the association of heart rate (HR) and heart rate variability (HRV) with cardiorespiratory fitness (CRF) in adults. This cross-sectional study included 204 participants: 132 young adults (67% women; 22.3 ± 2.3 years) and 72 middle-aged adults (53% women; 53.2 ± 5 years). HR and HRV were measured using a Polar RS800CX heart rate monitor. CRF was assessed using a metabolic cart during an incremental test. HR was negatively associated with CRF relative to body weight (BW) in young adults adjusting for sex, age, and physical activity (ß ranged from -0.200 to -0.195; all P ≤ 0.022). These associations disappeared after including fat mass as a covariate (all P ≥ 0.106) while remained significant after adjusting for fat-free mass (FFM; all P ≤ 0.008). Neither HR nor HRV variables were associated with CRF expressed as absolute values or relative to FFM in young and middle-aged adults after adjusting for the abovementioned covariates (all P ≥ 0.074). Our results suggest that HR rather than HRV is better associated with CRF relative to BW in young adults. However, this association seems to be explained by the inclusion of fat mass in the calculation of CRF relative to BW. HighlightsHeart rate and heart rate variability variables have been associated with cardiorespiratory fitness.Our present results, and previous literature, suggest that the "simple" measurement of the heart rate could be easier to obtain and interpret than the heart rate variability variables.The heart rate variable rather than the heart rate variability variables is better associated with cardiorespiratory fitness relative to body weight in healthy young adults.

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.

Intravascular Lithotripsy for the Treatment of Stent Underexpansion: The Multicenter IVL-DRAGON Registry.

Background: Whereas the efficacy and safety of intravascular lithotripsy (IVL) have been confirmed in de novo calcified coronary lesions, little is known about its utility in treating stent underexpansion. This study aimed to investigate the impact of IVL in treating stent underexpansion. Methods and Results: Consecutive patients with stent underexpansion treated with IVL entered the multicenter IVL-Dragon Registry. The procedural success (primary efficacy endpoint) was defined as a relative stent expansion >80%. Thirty days device-oriented composite endpoint (DOCE) (defined as a composite of cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint. A total of 62 patients were enrolled. The primary efficacy endpoint was achieved in 72.6% of patients. Both stent underexpansion 58.5% (47.5−69.7) vs. 11.4% (5.8−20.7), p < 0.001, and the stenotic area 82.6% (72.4−90.8) vs. 21.5% (11.1−37.2), p < 0.001, measured by quantitative coronary angiography improved significantly after IVL. Intravascular imaging confirmed increased stent expansion following IVL from 37.5% (16.0−66.0) to 86.0% (69.2−90.7), p < 0.001, by optical coherence tomography and from 57.0% (31.5−77.2) to 89.0% (85.0−92.0), p = 0.002, by intravascular ultrasound. Secondary endpoint occurred in one (1.6%) patient caused by cardiac death. There was no target lesion revascularization or target vessel myocardial infarction during the 30-day follow-up. Conclusions: In this real-life, largest-to-date analysis of IVL use to manage underexpanded stent, IVL proved to be an effective and safe method for facilitating stent expansion and increasing luminal gain.

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.

Immersive Virtual Reality Influences Physiologic Responses to Submaximal Exercise: A Randomized, Crossover Trial.

Objectives: This cross-sectional, randomly assigned study aimed to assess the influence of immersive virtual reality (VR) on exercise tolerance expressed as the duration of a submaximal exercise test (ET) on a cycle ergometer. Methods: The study enrolled 70 healthy volunteers aged 22-25years. Each participant performed an ET with and without VR. Time- and frequency-domain heart rate variability (HRV) parameters were analyzed for the first 3min (T1), the last 3min (T2), and the time at which the shorter of the two tests terminated (Tiso). In the time domain, a SD of R-R intervals (SDNN) and a root mean square of successive R-R interval differences (RMSSD) in milliseconds were computed. The following spectral components were considered: low frequency (LF), high frequency (HF), total power (TP), and LF/HF ratio. The study was registered in ClinicalTrials.gov (NCT04197024). Results: Compared to standard ET, tests in immersive VR lasted significantly longer (694 vs. 591s, p<0.00001) and were associated with lower HR response across the range of corresponding exercise levels, averaging 5-8 beats/min. In the multiple regression analysis, the ET duration was positively determined by male sex, immersion in VR, and negatively determined by HRT1 and RMSSDT1. Conclusion: Exercising in VR is associated with lower HR which allowed subjects to exercise for a longer time before reaching target heart rate (HR). In addition, the increase in exercise duration was found to be related to an adjustment in autonomic nervous activity at a given work rate favoring parasympathetic predominance.