The Prognostic Significance of Atrial Fibrillation and Left Atrium Size in Patients with Aortic Stenosis.

Aim    Aortic stenosis increases left atrial (LA) pressure and may lead to its remodeling. This can cause supraventricular arrhythmia. The aim of this study was to determine if the size of the LA and the presence of atrial fibrillation are related to the prognosis of patients with aortic stenosis.Material and methods    Clinical evaluation and standard transthoracic echocardiographic studies were performed in 397 patients with moderate to severe aortic stenosis.Results    In all patients, LA dimension above the median (≥43 mm) was associated with a significantly higher risk of death [HR 1.79 (CL 1.06-3.03)] and a LA volume above the median of 80 ml was associated with a significantly higher risk of death [HR 2.44 (CI 1.12-5.33)]. The presence of atrial fibrillation was significantly associated with a higher risk of death (p <0.0001). The presence of atrial fibrillation [HR 1.69 (CI 1.02-2.86)], lower left ventricular ejection fraction [HR 1.23 (CI 1.04-1.45)], higher NYHA heart failure class [HR 4.15 (CI 1.40-13.20)] and renal failure [HR 2.10 (CI 1.31-3.56)] were independent risk factors of death in patients in aortic stenosis.Conclusion    The size and volume of the LA and the occurrence of atrial fibrillation are important risk factors for death in patients with aortic stenosis. The presence of renal dysfunction, low left ventricular ejection fraction, high NYHA functional class and atrial fibrillation are independent risk factors of poor prognosis in patients with aortic stenosis.

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.

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.

Ultrasonographic caval indices do not significantly contribute to predicting fluid responsiveness immediately after coronary artery bypass grafting when compared to passive leg raising.

BACKGROUND: Appropriate fluid management is one of the most important elements of early goal-directed therapy after cardiothoracic surgery. Reliable determination of fluid responsivenss remains the fundamental issue in volume therapy. The purpose of the study was to assess the usefulness of dynamic IVC-derived parameters (collapsibility index, distensibility index) in comparison to passive leg raising, in postoperative fluid management in mechanically ventilated patients with left ventricular ejection fraction ≥ 30 %, immediately after elective coronary artery bypass grafting. METHODS: Prospective observational case series study including 35 patients with LVEF ≥ 30 %, undergoingelective coronary artery bypass grafting was conducted. Transthoracic echocardiography, passive leg raising and intravenous administration of saline were performed in all study subjects. Dynamic parameters derived from ultrasonographic assessment of the IVC diameter (collapsibility index-CI and distensibility index-DI), cardiac output RESULTS: There were 24 (68.57 %) responders in the study population. There were no statistical differences between the groups in relation to: clinical parameters, pre- and postoperative LVEF, fluid balance and CVP. Change in cardiac output after passive leg raising correlated significantly with that after the volume expansion (p=0.000, r=0.822). Dynamic IVC derivatives were slightly higher in fluid responders, however this trend did not reach statistical significance. None of the caval indices correlated with fluid responsiveness. CONCLUSION: Dynamic IVC-derived parameters do not predict fluid responsiveness in mechanically ventilated patients with preserved ejection fraction immediately after elective coronary artery bypass grafting. Passive leg raising is not inferior to volume expansion in differentiating between fluid responders and nonresponders. Immediate fluid challenge after CABG is safe and well tolerated.

Preoperative and mid-term right ventricular systolic function assessment, at rest and during exercise, with speckle-tracking echocardiography after left ventricular assist device implantation.

OBJECTIVES: The study aimed to compare pre- and postoperative resting as well as postprocedural resting and exertional right ventricular speckle-tracking echocardiographic parameters at a mid-term follow-up after left ventricular assist device (LVAD) implantation. METHODS: Patients with implanted third-generation LVADs with hydrodynamic bearings were prospectively enrolled (NCT05063006). Myocardial deformation was evaluated before pump implantation and at least three months after the procedure, both at rest and during exercise. RESULTS: We included 22 patients, 7.3 months (IQR, 4.7-10.2) after the surgery. The mean age was 58.4 ± 7 years, 95.5% were men, and 45.5% had dilated cardiomyopathy. The RV strain analysis was feasible in all subjects both at rest and during exercise. The RV free wall strain (RVFWS) worsened from -13% (IQR, -17.3 to -10.9) to -11.3% (IQR, -12.9 to -6; p = 0.033) after LVAD implantation with a particular decline in the apical RV segment [-11.3% (IQR, -16.4 to -6.2) vs -7.8% (IQR, -11.7 to -3.9; p = 0.012)]. The RV four-chamber longitudinal strain (RV4CSL) remained unchanged [-8.5% (IQR, -10.8 to -6.9) vs -7.3% (IQR, -9.8 to -4.7; p = 0.184)]. Neither RVFWS (-11.3% (IQR, -12.9 to -6) vs -9.9% (IQR, -13.5 to -7.5; p = 0.077) nor RV4CSL [-7.3% (IQR, -9.8 to -4.7) vs -7.9% (IQR, -9.8 to -6.3; p = 0.548)] changed during the exercise test. CONCLUSIONS: In patients who are pump-supported, the right ventricular free wall strain tends to worsen after LVAD implantation and remains unchanged during a cycle ergometer stress test.

Thrombin generation, fibrin clot permeation and lysis in patients with severe mitral regurgitation undergoing transcatheter edge-to-edge mitral valve repair: Mitral Fibrin Study.

INTRODUCTION: The intricate management of heart failure (HF), especially in the context of reduced ejection fraction, is compounded by an elevated risk of thromboembolic events. Existing studies offer inconclusive insights into the interplay between MR and the coagulation system. OBJECTIVES: This study aimed to investigate the impact of transcatheter edge-to-edge repair (TEER) on specific coagulation parameters in HF patients. PATIENTS AND METHODS: A cohort of 31 HF patients with severe MR undergoing TEER underwent systematic evaluation at three time points (V1, V2, and V3). Coagulation parameters, including fibrinogen concentration, thrombin generation, fibrin clot permeability (Ks), and clot lysis time (CLT), were assessed (n = 27 [V2], and n = 25 [V3]). RESULTS: TEER induced changes in fibrinogen levels (P = 0.01, V3 vs. V2) and improved fibrin clot properties over a 50-day follow-up (Ks, P = 0.01, V3 vs. V2). No significant differences were observed among time points in analyzed blood clot parameters. Correlation analysis showed that baseline CLT was significantly associated with delta NT-proBNP, (P = 0.049; r = 0.40). Multivariable analysis demonstrated that baseline CLT was an independent predictor of the early post-TEER NT-proBNP change (R2 = 0.55, P = 0.02). CONCLUSIONS: We found that fibrinogen levels decreased, and permeation coefficient increased over a median 50-day post-TEER follow-up, compared to early post-procedure assessments. Other blood coagulation parameters remained unchanged from baseline to both follow-up periods after TEER. Finally, CLT was an independent predictor of early NT-proBNP increase, emphasizing its role as an indicator of the hemodynamic response to TEER.

Hemodynamic parameters of aortic valve prostheses - KRAK-AS registry analysis.

Introduction: The treatment of choice for aortic stenosis is a valve replacement. Some patients have post-procedural increased pressure gradient on the implanted prosthesis because of patient-prosthesis mismatch (PPM), known to adversely influence prognosis. The PPM risk should be initially predicted and effort made to avoid this complication, specifically in large body size patients. Aim: To assess the frequency of PPM taking into account the valvular prosthesis type in a real-life population of consecutive patients included in the Krakow aortic stenosis registry. Material and methods: The KRAK-AS registry was conducted in July-October 2016. Patients were assessed before and after valve surgery and during the 3-year follow-up. Patients who underwent aortic valve intervention were clinically and echocardiographically evaluated within a month after surgery and divided into groups depending on the implanted prosthesis type. Analysis of patients with a smaller (< 23 mm) and larger than median (≥ 23 mm) valve diameter was performed. Results: The valve implantation was performed in 229 patients (42 mechanical, 139 biological, 48 transcatheter). No differences between patient groups compared by PPM occurrence was seen at baseline. Median age was 70 years; 55.5% were men. At least moderate PPM (iEOA ≤ 0.85 cm2/m2) was observed in 40% of mechanical valves, 33% of biological valves, and was significantly less frequent (10%) in patients after transcatheter valve implantation, p = 0.0001. Severe PPM (iEOA < 0.65 cm2/m2) was found in 17.6% of mechanical valve PPM patients, 4.3% of biological ones, and no patients after transcatheter procedure. Conclusions: PPM is a frequent phenomenon in the real-life population of patients undergoing surgical aortic valve replacement, being significantly less frequent in the case of a transcatheter procedure.

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.

Right ventricular-pulmonary arterial coupling in patients with implanted left ventricular assist devices.

OBJECTIVE: Both the right ventricular (RV) contractile function and pulmonary arterial (PA) pressure influence clinical outcomes in patients supported with left ventricular assist devices (LVADs), but the impact of RV-PA coupling is unknown. This study aimed to determine the prognostic impact of RV-PA coupling in patients with implanted LVADs. METHODS: Patients with implanted third-generation LVADs were retrospectively enrolled. The RV-PA coupling was assessed preoperatively by the ratio of RV free wall strain (RVFWS) derived from speckle-tracking echocardiography and noninvasively measured peak RV systolic pressure (RVSP). The primary end point was a composite of all-cause mortality or right heart failure (RHF) hospitalization. Secondary end points consisted of all-cause mortality at a 12-month follow-up and RHF hospitalization. RESULTS: A total of 103 patients were screened, and 72 with good RV myocardial imaging were included. The median age was 57 years; 67 patients (93.1%) were men, and 41 (56,9%) had dilated cardiomyopathy. A receiver-operating characteristic analysis (AUC 0.703, 51.5% sensitivity, 94.9% specificity) was used to identify the optimal cutoff point (0.28%/mmHg) for the RVFWS/TAPSE threshold. Nineteen subjects (26.4%) had advanced RV-PA uncoupling. Event rates were estimated using the Kaplan-Meier method showing a strong association with an increased risk for the primary end point of death or RHF hospitalization (89.47% vs. 30.19%, p < 0.001). A similar observation applied to all-cause mortality (47.37% vs. 13.21%, p = 0.003) and RHF hospitalization (80.43% vs. 20%, p < 0.001). CONCLUSIONS: An advanced RV dysfunction assessed by RV-PA coupling may serve as a predictor of adverse outcomes in patients with implanted LVADs.

Computed tomography guided tailored approach to transfemoral access in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Transfemoral approach (TFA) is the most common access route for transcatheter aortic valve implantation (TAVI). Percutaneous femoral access (PA) is preferred over the surgical approach (SA), however, may be associated with a higher risk of access site complications. Thus, we aimed to assess outcomes of computed tomography-guided tailored approach to percutaneous and surgical TFA in patients undergoing TAVI. METHODS: We evaluated data of 158 patients, who underwent TAVI via femoral route between January 2017 and December 2018. In the PA group, vascular closure was performed with the use of two percutaneous suture devices and an additional mechanical seal device. We compared complications rate and outcomes. RESULTS: Of the 158 patients (92%; mean age 79.6 years, 60.8% female), in 92 (61%) patients PA was performed and in 66 (39%) patients SA was used. Median (interquartile range) radiation exposure as well as contrast volume dose was higher in the PA group compared to the SA group 614.0 (410.0; 1104.0) mGy vs. 405 (240.5; 658.0) mGy (p < 0.001) and 150.0 (120.0; 180.7) mL vs. 130.0 (100.0; 160.0) mL (p = 0.04), respectively. Bleeding complications were similar in the PA group 11 (12.2%) compared to 5 (8.62%) in the SA group (p = 0.48). Median length of hospital stay was also similar in the PA and the SA group 6.00 (5.00; 8.00) days vs. 6.00 (4.00; 8.00) days, respectively (p = 0.31). CONCLUSIONS: Computed tomography-guided PA in TAVI may provide comparable procedural outcomes compared to the SA, despite a higher radiation dose and the use of contrast dye, while being less invasive.

How to Improve the Outcomes of LVAD Implantation?

BACKGROUND: Heart transplantation is the treatment of choice for selected patients with end-stage heart failure. Persistent donor organ shortage has resulted in a growing interest in mechanical circulatory support not only as a bridge to transplantation but also as a destination therapy. METHODS: The aim of the study was to analyze the indications, comorbidities, operative technique, complications, and follow-up of all patients undergoing left ventricular assist device implantation in one of the most experienced clinics in Poland between 2015 and 2020 and state the best timing of the procedure. RESULTS: This study included 78 individuals (72 males, 92%; 6 females, 8%) with a median age of 57 years (range, 50-62 years). The median body mass index was 27.12 (range, 25.2-29.5). The etiology of cardiomyopathy was ischemic (n = 31, 39%), dilated cardiomyopathy (n = 47, 60%), and others. Sixty-four patients presented with New York Heart Association class IV (82%). Leading heart rhythm was sinus (n = 31, 40%) and pacemaker rhythm (n = 47, 60%). Sixty-four patients had implantable cardioverter defibrillator implantation (82%). Preoperative echocardiography revealed a median left ventricle ejection fraction of 14.5% (range, 10%-15%) and LV dimension 7.55 cm (range, 6.9-8.275 cm). In 51 patients (65%), imaging confirmed pulmonary hypertension. The intensive care unit stay was 6 days (range, 4.25-11.75 days). Median time to extubation was 25 hours (range, 23.75-70 hours). The median time to discharge was 31.5 days (range, 25-31.85 days). In-hospital mortality was 12 patients (15%). Median follow-up time was 19.5 months (range, 11.25-31 months) months, with the longest follow-up of about 53 months. CONCLUSIONS: Appropriate selection of candidates and timing of left ventricular assist device implantation are critical for improved outcomes of destination therapy.

Echo-guided left ventricular assist device speed optimisation for exercise maximisation.

OBJECTIVE: Current generation left ventricular assist devices (LVADs) operate with a fixed rotation speed and no automated speed adjustment function. This study evaluates the concept of physiological pump speed optimisation based on aortic valve opening (AVO) imaging during a cardiopulmonary exercise test (CPET). METHODS: This prospective crossover study (NCT05063006) enrolled patients with implanted third-generation LVADs with hydrodynamic bearing. After resting speed optimisation, patients were randomised to a fixed-modified speed or modified-fixed speed CPET sequence. Fixed speed CPET maintained baseline pump settings. During the modified speed CPET, the LVAD speed was continuously altered to preserve periodic AVO. RESULTS: We included 22 patients, the mean age was 58.4±7 years, 4.5% were women and 54.5% had ischaemic cardiomyopathy. Exertional AVO assessment was feasible in all subjects. Maintaining periodic AVO allowed to safely raise the pump speed from 2900 (IQR 2640-3000) to 3440 revolutions per minute (RPM) (IQR 3100-3700; p<0.001). As a result, peak oxygen consumption increased from 11.1±2.4 to 12.8±2.8 mL/kg/min (p<0.001) and maximum workload from 1.1 (IQR 0.9-1.5) to 1.2 W/kg (IQR 0.9-1.7; p=0.028). The Borg scale exertion level decreased from 15.2±1.5 to 13.5±1.2 (p=0.005). CONCLUSIONS: Transthoracic AVO imaging is possible during CPETs in patients with LVAD. Dynamic echo-guided pump speed adjustment based on the AVO improves exercise tolerance and augments peak oxygen consumption and maximum workload.

Balloon aortic valvuloplasty for severe aortic stenosis may reduce mitral regurgitation in mid-term follow-up.

Introduction: Mitral regurgitation (MR) is a frequent complication in patients with severe aortic stenosis (AS). Material and methods: Echocardiographic assessment of MR was performed at baseline, at 30 days and at 6 months after balloon aortic valvuloplasty (BAV). Results: Data of 271 patients were included in our final analysis, of which 21.2% (n = 85) had at least moderate MR at baseline (in 19 (22.3%) subjects MR was diagnosed as primary). Both groups showed similar severity of AS, but patients in the MR group had a greater left ventricle (LV) size (p = 0.003 for LVESD, p = 0002 for LVEDD) and slightly lower LV ejection fraction (p = 0.04). Mitral regurgitation parameters significantly improved both at 30 days and 6 months after BAV in the MR group (MR jet area: 7.2 (4.5-9.9) vs. 3.6 (2.3-7.2) cm2, and 7.2 (4.5-9.9) vs. 3.2 (2.1-6.7) cm2; %MR/left atrial area 34.5 (23.4-42.7) vs. 17.5 (9.3-29.5) and 34.5 (23.4-42.7) vs. 14.5 (8.3-24.5), p < 0.001 for all). In multivariate logistic regression analysis, the change at 30 days, from baseline, in the LVESD (OR = 1.87; 95% CI: 1.23-2.87; p < 0.001) and LVEF (OR = 0.95; 95% CI: 0.87-1.01; p < 0.001); MR jet area (OR = 2.2, 95% CI: 1.5-4.6; p < 0.001) and the presence of primary MR (OR = 3.2, 95% CI: 1.04-5.98; p < 0.001) were retained as independent predictors of significant persisting MR at 6 months. Conclusions: Balloon aortic valvuloplasty may reduce MR in mid-term follow-up. Predictors of persistent MR at 6 months after BAV included an increase of LVESD and MR jet area and decrease of LVEF at 30 days.

Balloon Aortic Valvuloplasty for Severe Aortic Stenosis as Rescue or Bridge Therapy.

The study aimed to assess procedural complications, patient flow and clinical outcomes after balloon aortic valvuloplasty (BAV) as rescue or bridge therapy, based on data from our registry. A total of 382 BAVs in 374 patients was performed. The main primary indication for BAV was a bridge for TAVI (n = 185, 49.4%). Other indications included a bridge for AVR (n = 26, 6.9%) and rescue procedure in hemodynamically unstable patients (n = 139, 37.2%). The mortality rate at 30 days, 6 and 12 months was 10.4%, 21.6%, 28.3%, respectively. In rescue patients, the death rate raised to 66.9% at 12 months. A significant improvement in symptoms was confirmed after BAV, after 30 days, 6 months, and in survivors after 1 year (p < 0.05 for all). Independent predictors of 12-month mortality were baseline STS score [HR (95% CI) 1.42 (1.34 to 2.88), p < 0.0001], baseline LVEF <20% [HR (95% CI) 1.89 (1.55-2.83), p < 0.0001] and LVEF <30% at 1 month [HR (95% CI) 1.97 (1.62-3.67), p < 0.0001] adjusted for age/gender. In everyday clinical practice in the TAVI era, there are still clinical indications to BAV a standalone procedure as a bridge to surgery, TAVI or for urgent high risk non-cardiac surgical procedures. Patients may improve clinically after BAV with LV function recovery, allowing to perform final therapy, within limited time window, for severe AS which ameliorates long-term outcomes. On the other hand, in patients for whom an isolated BAV becomes a destination therapy, prognosis is extremely poor.

Inpatient Cardiac Rehabilitation after Transcatheter Aortic Valve Replacement Is Associated with Improved Clinical Performance and Quality of Life.

Cardiac rehabilitation (CR) provides multifactorial support and intervention for cardiac patients and improves quality of life (QoL). We aimed to assess clinical performance and QoL changes in patients undergoing transcatheter aortic valve replacement (TAVR) scheduled directly to inpatient CR (CR group) and those who were discharged home (DH group). The following patient-related outcomes were recorded: 5 m walk time (5MWT), 6 min walk test (6MWT), handgrip strength (HGS) with dynamometer, Katz index of Independence of Activities in Daily Living (KI of ADL), Hospital Anxiety and Depression Scores (HADS) Score. Quality of life was evaluated with Kansas City Cardiomyopathy Questionnaire (KCCQ). Baseline data, 30-day and 6- and 12-month data were assessed. The CR group consisted of 52 patients and 53 were in the discharged home (DH group). When we compared outcomes between the groups, the 5MWT, 6MWT, HGS KI of ADL, and KCCQ were significantly better in the CR group at 30 days (p = 0.03, p = 0.01, p = 0.02, p = 0.048, respectively), and no difference was found in HADS scores. At 6 months, the effect of CR was sustained for 6MWT, HGS, KI of ADL, and KCCQ (p = 0.001, p = 0.001, p = 0.03, p = 0.003, respectively) but not for 5MWT. Interestingly, at 12 months, the CR group had better performance only in 6MWT and HGS compared with the DH group (p = 0.04, p = 0.03, respectively). We showed that inpatient CR is strongly associated with better clinical performance and QoL in patients undergoing TAVR. All patients may benefit from CR after TAVR. The most important aspect of inpatient CR after TAVR from the patient's perspective may be better performance in daily activities; however, performance was attenuated after 1 year.

Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis.

OBJECTIVES: Long-term durability of bioprosthetic valves is predominantly limited by structural valve deterioration. RESILIA™ tissue has exhibited reduced calcification in pre-clinical and early clinical studies. This study evaluated the 5-year clinical and haemodynamic outcomes of an aortic valve with this tissue. METHODS: This was a prospective, non-randomized, single-arm study of 133 patients implanted with a RESILIA aortic bioprosthesis between July 2011 and February 2013 at 2 sites in Poland. Clinical outcomes and haemodynamic performance were assessed annually for 5 years post-implant. Safety events were adjudicated by a Clinical Events Committee and echocardiographic data were assessed by an independent core laboratory. RESULTS: Mean patient age was 65.3 ± 13.5 years, with 34 patients (25.6%) ≤60. The mean follow-up was 4.2 ± 1.5 years. Early (≤30 days) and late (>30 days) all-cause mortality were 2.3% (N = 3) and 3.2%/late patients-years (N = 18) respectively. Early events included thromboembolism in 3 patients (2.3%). Late valve-related events included endocarditis in 1 patient, which led to explant, and valve thrombosis in another patient. There were no events of structural valve deterioration throughout the study. At 5 years, mean gradient was 14.8 ± 7.6 mmHg and effective orifice area was 1.4 ± 0.5 cm2, a marked improvement over baseline values. All New York Heart Association class III patients and most class II patients at baseline had improved classifications at 5 years. CONCLUSIONS: The bioprosthesis with RESILIA tissue demonstrated a good safety profile with excellent haemodynamic performance over 5 years of follow-up. These encouraging outcomes warrant additional investigation of this novel tissue. CLINICAL TRIAL REGISTRATION NUMBER: NCT01651052.

Twelve-month outcomes of transapical transcatheter aortic valve implantation in patients with severe aortic valve stenosis.

INTRODUCTION: Transapical access (TA) transcatheter aortic valve implantation (TAVI) (TA-TAVI) represents one of the possible routes in patients with severe aortic stenosis (AS) who are not suitable for transfemoral access. AIM: To assess early- and mid-term clinical outcomes after TA-TAVI. MATERIAL AND METHODS: Patients with severe symptomatic AS undergoing TA-TAVI from November 2008 to December 2019 were enrolled. Clinical and procedural characteristics as well as clinical outcomes including all-cause mortality during 12-month follow-up were assessed. RESULTS: Sixty-one consecutive patients underwent TA-TAVI for native AS. Patients were elderly with median age of 80.0 (76.0-84.0) years; 55.7% were males. Median baseline EuroSCORE I and STS scores were 18.2% (11.6-27.7) and 4.8% (3.3-8.2), respectively. The procedural success rate was 96.7%. In-hospital, 30-day and 12-month mortality rates were 9.8%; 18.0% and 24.6%, respectively. The main periprocedural and in-hospital complications were bleeding complications (14.8%). The following factors were associated with 12-month mortality: previous cerebrovascular event (CVE), glomerular filtration rate (GFR), aortic valve area (AVA), right ventricular systolic pressure (RVSP) and serum level of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) (RR for CVE 3.17, 95% confidence interval (CI): 1.15-8.76: p = 0.026; RR for AVA per 0.1 cm2 1.28, 95% CI: 1.03-1.55: p = 0.024; RR for GFR per 1 ml/min 0.96: 95% CI: 0.94-0.99: p = 0.007; RR for NT-proBNP per 1000 pg/ml 1.07: 95% CI: 1.01-1.17: p = 0.033; RR for RVSP per 1 mm Hg 1.07: 95% CI 1.02-1.16: p = 0.011). CONCLUSIONS: Transapical TAVI in high-risk patients provides good hemodynamic results with acceptable outcomes.

Direct left ventricular wire pacing during transcatheter aortic valve implantation.

BACKGROUND: Rapid ventricular pacing is used during balloon aortic valvuloplasty, balloon­expandable transcatheter aortic valve implantation (TAVI), and for postdilatation. Right ventricular (RV) lead pacing has been regarded as a gold standard. Direct left ventricular (LV) wire pacing has recently been considered safe and effective in TAVI interventions. AIMS: This study aimed to analyze procedural outcomes of direct LV pacing compared with RV stimulation in unselected patients undergoing TAVI. METHODS: Direct LV wire pacing was provided via available preshaped guidewires and used only when no predictors of atrioventricular block were present. The primary study objective was the assessment of the efficacy of direct LV wire pacing. The secondary objectives included the evaluation of procedure duration and safety in comparison with the conventional method. A combined endpoint (major adverse cardiovascular event) was defined as the occurrence of death, stroke, venous puncture-related complications, and cardiac tamponade. RESULTS: In 2017 and 2018, 143 patients underwent transfemoral TAVI. Of these, 114 (79.7%) had self­ ­expandable valves implanted. Direct LV wire pacing was the dominant method of pacing (82 patients [57.3%]), and its efficacy reached 97.6%. The median (interquartile range) procedure time was shorter in the direct LV wire pacing group (80 [70-90] min vs 85 [70-95] min; P = 0.02). Major adverse cardiovascular events were more frequent in the RV lead pacing group (11.5% vs 4.9%), but no statistical significance was achieved (P = 0.13). CONCLUSIONS: Direct LV wire pacing during TAVI is a simple, reproducible, and safe technique, which provides reliable, sustained stimulation with a low complication rate and potential reduction of procedural time.

Early results of the ongoing Polish Registry of Valve Thrombosis after Transcatheter Aortic Valve Implantation (ZAK­POLTAVI).

BACKGROUND: Conflicting data exist regarding the risk factors for transcatheter heart valve thrombosis (THVT). In addition, no optimal pharmacological strategy to treat THVT has been established so far Aims: The aim of this study was to assess the incidence, risk factors, diagnostic workup, and treatment of THVT in Poland. METHODS: Data were collected retrospectively in themulticenter registry of patients with THVT (ZAK­POLTAVI) between November 2008 and November 2018. Transcatheter heart valve thrombosis was defined as an increased mean transvalvular gradient accompanied by a decreased effective orifice area or severe aortic regurgitation, reversible after treatment. Baseline characteristics and procedural data were compared between patients with THVT and those without THVT (matched by age, sex, and diabetic status). RESULTS: In a group of 2307 patients undergoing transcatheter aortic valve implantation (TAVI), 26 patients with THVT were identified (incidence, 1.14%). In half of the patients, THVT was diagnosed within 6 months after TAVI. As compared with the control group, patients with THVT more frequently had chronic obstructive pulmonary disease (P = 0.035), a smaller aortic valve area (P = 0.007), a higher mean postprocedural transvalvular gradient (P = 0.037), and a lower platelet count (P = 0.029) at the time of the diagnosis. A total of 24 patients (84.6%) received anticoagulation therapy for THVT, and complete resolution of THVT was noted in 12 individuals (46.1%). We observed thromboembolic complications in 2 patients (7.7%). CONCLUSIONS: Transcatheter heart valve thrombosis is a rare complication of TAVI. However, a higher risk of THVT may be expected in patients with chronic obstructive pulmonary disease, a smaller aortic valve area, a higher mean postprocedural transvalvular gradient, and a lower platelet count. Anticoagulation alone or combined with antiplatelet therapy seems to be the optimal pharmacological treatment in this population.

Intermediate-term outcomes after aortic valve replacement with a novel RESILIATM tissue bioprosthesis.

BACKGROUND: The durability of bioprosthetic heart valves is limited by structural valve deterioration (SVD) due to long-term calcification. A novel bioprosthetic tissue (RESILIATM) has been developed which, in preclinical studies, has shown reduced calcification. The purpose of this study was to evaluate the intermediate-term clinical outcomes and hemodynamic performance of this tissue. METHODS: A prospective, single-arm, observational trial was conducted in patients who required surgical aortic valve replacement (AVR). Between July 2011 and February 2013, 133 patients were implanted at two sites in Poland. Hemodynamic performance and clinical outcomes were assessed annually through 4 years of follow-up. All safety events were adjudicated by an independent Clinical Events Committee, and echocardiographic data were evaluated by a core laboratory. RESULTS: Patients were 65.3±13.5 years old and 26% were ≤60 years old. The average follow-up was 3.8±1.1 (median: 4.1; IQR, 4.0-4.3) years. Early (≤30 day) and late (>30 day) all-cause mortality rates were 2.3% (n=3) and 3.2% late patient-years (n=16), respectively. There were no cases of early or late SVD. There was one early case of major paravalvular leak (0.8%), and no late cases. At 4 years, the mean gradient was 14.5±7.4 mmHg and the effective orifice area was 1.6±0.4 cm2, both markedly improved from baseline. At 4 years, the New York Heart Association functional class had improved from baseline in 54.5% of patients. CONCLUSIONS: The aortic bioprosthesis with novel RESILIATM tissue demonstrated excellent hemodynamic performance and safety outcomes over 4 years. Longer follow-up will be important to confirm the durability of this bioprosthesis.