Pre-procedural abnormal function of von Willebrand Factor is predictive of bleeding after surgical but not transcatheter aortic valve replacement.

Both transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) have been proven to effectively correct von Willebrand Factor (vWF) pathologies, however there is limited data simultaneously comparing outcomes of both approaches. We prospectively enrolled patients with severe aortic stenosis referred for TAVI (n = 52) or SAVR (n = 48). In each case, vWF antigen (vWF:Ag), vWF activity (vWF:Ac) and activity-to-antigen (vWF:Ac/Ag) ratio were assessed at baseline, 24 h and 72 h after procedure. VWF abnormalities were defined as reduced vWF:Ac/Ag ratio (< 0.8). Bleeding events in both arms were classified according to Valve Academic Research Consortium (VARC-2) definitions. Overall, there was no difference between patients referred for TAVI and SAVR in vWF:Ac (1.62 ± 0.52 vs 1.71 ± 0.64; p = 0.593), vWF:Ag (1.99 ± 0.81 vs 2.04 ± 0.81; p = 0.942) or vWF:Ac/Ag ratio (0.84 ± 0.16 vs 0.85 ± 0.12; p = 0.950). Pathological vWF:Ac/Ag ratio was found in 20 (38%) TAVI and 15 (31%) SAVR patients (p = 0.407). Normalization of vWF:Ac/Ag ratio at day 3 after procedure was achieved in 19 (95%) TAVI and 13 (87%) SAVR patients (p = 0.439). Similar prevalence of major or life-threatening bleedings (MLTB) after TAVI and SAVR in entire groups was observed (19% vs. 23%, p = 0.652). VWF abnormalities were associated with higher incidence of MLTB in SAVR (53% vs 9%, p < 0.001), but not TAVI (15% vs. 22%, p = 0.132). Accordingly, in receiver-operating characteristic curve analysis vWF:Ac/Ag ratio < 0.8 showed significant sensitivity and specificity for predicting MLTB in SAVR group (AUC 0.735, 95% CI 0.538-0.931, p = 0.019). We proved that abnormal function of vWF is corrected successfully after both TAVI and SAVR, but vWF abnormalities are predictive of MLTB only in surgical patients.

Percutaneous pulmonary valve implantation in patients after Ross procedure: role of intravascular ultrasound.

Coronary compression exclusion during right ventricle outflow tract stenting is recommended and potential oversight may be fatal. Balloon inflation in right ventricle outflow tract with simultaneous aortography can be inconclusive or falsely negative. We present a case of 27-year-old male post Ross operation qualified for percutaneous pulmonary valve implantation. Neither of the conventional views obtained provided a definite exclusion of coronary compression, therefore an intravascular ultrasound of the left coronary artery before and during balloon inflation in right ventricle outflow tract was performed. Acquired images allowed excluding potential constriction, thus a covered stent and pulmonary valve were implanted and the procedure was concluded. Two hours later, the patient complained of chest pain. Transthoracic echocardiography demonstrated a significant pericardial effusion. Retrospective analysis of the final angiogram revealed a possibility of subtle extravasation at the distal part of the homograft. A hybrid procedure consisting of additional covered stent implantation, pericardial drainage, and second pulmonary valve implantation was performed with an acceptable result. To conclude, in case of doubtful or unconvincing images obtained from aortography or selective angiography during balloon inflation in right ventricle outflow tract, intravascular ultrasound might be a feasible and useful technique. Signs of homograft rupture may be subtle, whereas symptoms of cardiac tamponade delayed. In selected patients percutaneous treatment of homograft rupture is achievable and beneficial.

Concomitant coronary artery disease and its management in patients referred to transcatheter aortic valve implantation: Insights from the POL-TAVI Registry.

BACKGROUND: Coronary artery disease (CAD) and degenerative aortic stenosis often coexist. However, the impact of CAD and its management on the prognosis after transcatheter aortic valve implantation (TAVI) remains uncertain. We sought to evaluate the impact of obstructive CAD, SYNTAX score (Ss), and percutaneous coronary intervention (PCI) prior to TAVI on short-term outcome. METHODS: Overall, 896 patients who underwent TAVI after heart team decision was included. Pre-procedural angiograms were analysed to calculate baseline Ss (bSs) and residual Ss (rSs). Baseline, procedural and follow-up data up to 30 days was acquired from the national POL-TAVI registry. RESULTS: Patients with obstructive CAD at baseline (n = 462, 52%) had higher mortality as compared with the remaining (8.7 vs. 5.1%, log-rank P = 0.039). Also, after correction for confounding factors obstructive CAD was identified as independent predictor of mortality (hazard ratio [HR] 1.74, 95% confidence intervals [CIs] 1.03-2.94, P = 0.037). In obstructive CAD, neither bSs (AUC 0.47, CI 0.38-0.56, P = 0.47) nor rSs (AUC 0.47, CI 0.30-0.64, P = 0.72 for those undergoing PCI and AUC 0.48, CI 0.37-0.59, P = 0.75 for the remaining) was predictive of mortality. When revascularization status was considered, patients with PCI prior to TAVI had similar outcome as those without obstructive CAD at baseline (7.7 vs. 5.1%, log-rank P = 0.23) with no negative impact on mortality (HR 1.13, CI 0.62-2.09, P = 0.69). CONCLUSIONS: In conclusion, obstructive CAD at baseline evaluation for TAVI has independent negative impact on short-term prognosis. However, neither baseline nor residual Ss values have prognostic ability in patients undergoing TAVI. Revascularization prior to TAVI seems to improve survival to levels comparable with patients without obstructive CAD at baseline.

Percutaneous Closure of Post-Infarction Ventricular Septal Defects-An Over Decade-long Experience.

OBJECTIVES: To report an over decade-long experience with percutaneous post-infarction ventricular septal defect (PIVSD) closure. BACKGROUND: PIVSDs remains a major clinical challenge with extremely high mortality. Data concerning interventional closure of PIVSD is scarce. METHODS: All percutaneous PIVSD closures performed between 2003 and 2016 in 8 participating centres were identified. Data concerning patients and procedures was acquired. Patients were divided into two groups, based on the time interval between VSD diagnosis and closure (≤14 days-acute phase, >14 days-non-acute phase). RESULTS: Twenty-one percutaneous PIVSD closures were performed on 20 patients (9 females, mean age: 70 years). Mean interval between the diagnosis and the procedure was 182.6 ± 500 days (range: 7-2228). Defects were mostly located in apical (55%) segments of the septum. In 7 cases (33%) the procedure was performed in the acute phase. The closure was technically successful in 17 cases (81%). Four patients died within 48 hours after the procedure. 30-days survival rate of the entire cohort was 70%. Univariate analysis revealed impact of technical success of the procedure (HR 0.13, CI 0.03-0.68 P = 0.016) and white blood cell count (HR 1.36 per unit increase, CI 1.1-1.69, P = 0.005) on 30-day mortality. CONCLUSIONS: In a selected population of patients percutaneous PIVSD closure is feasible and provides satisfactory survival rate. Procedural success has a protective impact on survival. Timing of the closure remains controversial. Procedure in the non-acute phase carries lower mortality, but at the same time introduces a selection bias. Larger registry-based studies are required.

Percutaneous closure of an aortopulmonary window using Amplatzer Duct Occluder II: Additional Sizes: the first reported case.

To date, there are no reported cases of the Amplatzer Duct Occluder II: Additional Sizes' use in percutaneous closure of an aortopulmonary window. We report a case of percutaneous closure of an aortopulmonary window in a 4.5-month-old, 6 kg child. Owing to the patient's low weight, high risk of damage to the pulmonary valve, as well as the possibility of aortic and pulmonary artery obstruction, classic implants were deemed unsuitable and a decision was made to use the Amplatzer Duct Occluder II: Additional Sizes. The implant performed very well - the soft waist filled the aortopulmonary connection and both retention discs were properly shaped and pressed against vessel walls. Echocardiogram performed 12 hours after the procedure confirmed a correct occluder position. Low-profile retention discs had no impact on pulmonary valve function, despite the defect's proximity to the valve. No obstruction of the aortic or pulmonary artery lumen was noted. The Amplatzer Duct Occluder II: Additional Size implant is a safe and useful device for percutaneous closure of an aortopulmonary window in a carefully selected group of patients.

Impact of previous coronary artery revascularization on outcomes in patients undergoing transcatheter aortic valve implantation.

Introduction: Coexistence of coronary artery disease (CAD) in patients with severe aortic stenosis (AS) referred for transcatheter aortic valve implantation (TAVI) raises questions regarding the safety and efficacy of TAVI in this subset of patients. Aim: To evaluate the impact of previous coronary revascularization in terms of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) on clinical outcomes after TAVI. Material and methods: A total of 507 consecutive patients who underwent TAVI were divided into: non-revascularization (NR), post-PCI and post-CABG groups. The endpoints were established according to VARC-2 definitions. Results: Patients with previous coronary revascularization (36.7% of the population) were younger, more often male and their EuroSCORE II risk evaluation was significantly higher (NR 7.9% vs. post-PCI 8.0% vs. post-CABG 20.5%, p < 0.0001). Patients after PCI or CABG prior to TAVI had similar 30-day all-cause mortality rates as those without coronary revascularization at baseline (NR vs. post-PCI vs. post-CABG: 8.1% vs. 5.5% vs. 6.8%, respectively; p = 0.6). There were no differences in 12-month all-cause mortality rates between groups (NR vs. post-PCI vs. post-CABG: 15.3% vs. 14.2% vs. 16.9%, respectively; log-rank p = 0.67). In the Cox proportional-hazards regression model, acute kidney injury stage 2-3 (HR = 3.7, 95% CI: 2.14-6.33; p < 0.001) and post-TAVI stroke (HR = 3.5, 95% CI: 1.57-7.8; p = 0.002) were independently correlated with 1-year mortality. Conclusions: TAVI seems to be a safe and effective procedure for the treatment of severe AS in patients with previous coronary revascularization.

Long-Term Mortality After TAVI for Bicuspid vs. Tricuspid Aortic Stenosis: A Propensity-Matched Multicentre Cohort Study.

Objectives: Patients with bicuspid aortic valve (BAV) stenosis were excluded from the pivotal trials of transcatheter aortic valve implantation (TAVI). We compared the in-hospital and long-term outcomes between patients undergoing TAVI for bicuspid and tricuspid aortic valve (TAV) stenosis. Methods: We performed a retrospective registry-based analysis on patients who underwent TAVI for BAV and TAV at five different centers between January 2009 and August 2017. The primary outcome was long-term all-cause mortality. Secondary outcomes were in-hospital mortality, procedural complications, and valve performance. Results: Of 1,451 consecutive patients who underwent TAVI, two propensity-matched cohorts consisting of 130 patients with BAV and 390 patients with TAV were analyzed. All-cause mortality was comparable in both groups up to 10 years following TAVI (HR 1.09, 95% CI: 0.77-1.51). Device success and in-hospital mortality were comparable between the groups (96 vs. 95%, p = 0.554 and 2.3 vs. 2.1%, p = 0.863, respectively). Incidence of procedural complications was similar in both groups, with a trend toward a higher rate of stroke in patients with BAV (5 vs. 2%, p = 0.078). Incidence of moderate or severe paravalvular leak (PVL) at discharge was comparable in both groups (2 vs. 2%, p = 0.846). Among patients with BAV, all-cause mortality was similar in self-expanding and balloon-expandable prostheses (HR 1.02, 95% CI: 0.52-1.99) and lower in new-generation devices compared to old-generation valves (HR 0.27, 95% CI 0.12-0.62). Conclusion: Patients who had undergone TAVI for BAV had comparable mortality to patients with TAV up to 10 years after the procedure. The device success, in-hospital mortality, procedural complications, and PVL rate were comparable between the groups. The high rate of neurological complications (5%) in patients with BAV warrants further investigation.

Impact of transcatheter aortic valve implantation on coexistent mitral regurgitation parameters.

BACKGROUND: Data on the impact of transcatheter aortic valve implantation (TAVI) on coexisting mitral regurgitation (MR) are still inconsistent. AIMS: The study aimed to evaluate the impact of TAVI on coexistent MR depending on its etiology. METHODS: Out of 311 patients treated with TAVI, we selected 48 with coexistent MR: functional (FMR; n = 26) or nonfunctional (nFMR; n = 22). The impact of the procedure on MR was quantitatively assessed during a 1­year follow­up using MR effective regurgitant orifice area (MR­EROA) and volume (MRV). RESULTS: Compared with baseline, no change of MR­EROA was observed at 1­year follow­up in all patients with MR (median [interquartile range (IQR)], 0.2 [0.17-0.23]cm2 vs 0.17 [0.14-0.2]cm2 ; P = 0.054). No change in MR­EROA was also noted either in FMR (median [IQR], 0.21 [0.17-0.27]cm2 vs 0.19 [0.14-0.25]cm2 ; P = 0.142) or nFMR (median [IQR], 0.17 [0.12-0.23] cm2 vs 0.17 [0.1-0.2] cm2 ; P = 0.238) cohorts. Decreased MRV was seen in theoverall MR population after TAVI (median [IQR], 32 [28-36]ml/beat vs 26 [22-28]ml/beat; P = 0.002). Similarly, decreased MRV was noted in both FMR (median [IQR], 33 [26-42] ml/beat vs 26 [20-40] ml/beat; P = 0.042) and nFMR (median [IQR], 30 [20-46] ml/beat vs 24 [15-33] ml/beat; P = 0.015) cohorts. CONCLUSIONS: Transcatheter aortic valve implantation had no impact on MR­EROA regardless of the etiology of regurgitation. However, the procedure reduced MRV in both FMR and nFMR.

Protamine sulfate during transcatheter aortic valve implantation (PS TAVI) - a single-center, single-blind, randomized placebo-controlled trial.

BACKGROUND: Bleeding complications after transcatheter aortic valve implantation (TAVI) negatively affect the post-procedural prognosis. Routine use of protamine sulfate (PS) to reverse unfractionated heparin after TAVI was never assessed in a randomized controlled trial. AIMS: The aim of this study was to assess the impact of PS on bleeding complications after TAVI. METHODS: Between December 2016 and July 2020 311 patients qualified to TAVI in one academic center were screened. Patients that met the inclusion criteria were randomized to either PS or normal saline administration at the moment of optimal valve deployment. Baseline, procedural, and follow-up data for up to 30 days were collected and analyzed. The primary endpoint (PE) was a composite of life-threatening and major bleeding according to Valve Academic Research Consortium within 48 hours after the procedure. RESULTS: Overall, 100 patients (48 males, median age 82 years) met the inclusion criteria and were included in the study. Forty-seven subjects (47%) were randomized to PS. The primary endpoint occurred in 29% of the study population. Despite numerically lower rates of PE in patients randomized to PS, a statistical significance was not reached (21% in the PS group and 36% in the placebo group; odds ratio [OR], 0.48; 95% confidence intervals [CI] 0.2-1.2; P = 0.11). There were no significant differences in secondary endpoints. CONCLUSIONS: Routine protamine sulfate administration did not significantly decrease the rate of major and life-threatening bleeding complications after TAVI. Larger studies are required to assess the impact of routine PS use.

Temporal trends of transcatheter aortic valve implantation in a high-volume academic center over 10 years.

BACKGROUND: Indications for transcatheter aortic valve implantation (TAVI) have gradually expanded since its introduction. AIMS: The aim was to analyze temporal trends in TAVI characteristics based on the experience of a high-volume academic center over the period of 10 years. METHODS: Five hundred and six consecutive (n = 506) patients with 1-year follow-up were divided into early (G1, years 2010-2013, n = 130), intermediate (G2, 2014-2016, n = 164) and recent (G3, 2017-2019, n = 212) experience groups. RESULTS: Patient's age remained constant over time (mean [SD]; G1 = 79.1 [7.1] years vs G2 = 79.1 [7.1] years vs G3 = 79.7 [6.6] years, P = 0.73) but surgical risk in G3 was lower (log Euroscore, median [IQR]: G1 = 14.0 [8.4-20.2] vs G2 = 12.0 [7.0-22.2] vs G3 = 5.1 [3.5-8.5]; P <0.001). Major/life-threatening bleeding (G1 = 26.9% vs G2 = 12.8% vs G3 = 9.4%; P <0.001), major vascular complications (G1 = 15.4% vs G2 = 8.5% vs G3 = 5.7%; P = 0.02) and moderate/severe paravalvular leak (G1 = 16.2% vs G2 = 11% vs G3 = 7.5%; P = 0.046) were decreasing with time. There was a significant drop in all-cause 1-year mortality in G3 (G1 = 20% vs G2 = 17.7% vs G3 = 9.1%; log rank = 0.01). CONCLUSIONS: The age of TAVI recipients remained unchanged over the last decade. Decreasing surgical risk coupled with improvements in procedural technique and care resulted in fewer periprocedural complications and better 1-year survival.

Percutaneous tricuspid edge-to-edge repair - patient selection, imaging considerations, and the procedural technique. Expert opinion of the Working Group on Echocardiography and Association of CardioVascular Interventions of the Polish Cardiac Society.

Tricuspid regurgitation (TR) is a common acquired valvular heart disease (VHD). TR has progressive character and is associated with impaired long-term survival in both symptomatic and asymptomatic subjects. Despite this knowledge, the overall number of tricuspid valve surgeries is very low worldwide and many patients with clear indications for intervention are left untreated. The development of less invasive transcatheter techniques may offer new treatment options in this growing population of patients. Out of various percutaneous methods proposed, tricuspid edge-to-edge repair has recently gained considerable attention. The article summarizes available data regarding this new treatment method.

Use of protamine sulfate during transfemoral transcatheter aortic valve implantation - a preliminary assessment of administration rate and impact on complications.

INTRODUCTION: Bleeding complications after transcatheter aortic valve implantation (TAVI) are an important issue and negatively affect survival. The rate and impact of protamine sulfate (PS) administration on bleeding complications after TAVI remain unclear. AIM: To assess the impact of PS on bleeding complications after TAVI. MATERIAL AND METHODS: Between March 2010 and November 2016 two hundred fifty-eight patients qualified for TAVI in one academic center were screened. Baseline, procedural and follow-up data up to 30 days were collected and analyzed. The primary endpoint (PE) was major bleeding according to the Valve Academic Research Consortium up to 48 h after the procedure. RESULTS: Overall, 186 patients (96 females, mean age: 80 years) met the inclusion criteria. Thirty-nine (21%) subjects received PS. PE occurred in 24.7% of the study population. There were no significant differences in terms of the PE rate between the groups (25.6% in the PS group and 24.7% in the remaining cohort, p = 0.9, odds ratio (OR) = 1.05, confidence interval (CI): 0.47-2.4, p = 0.9). Multivariate analysis identified female gender (OR = 2.2, CI: 1.08-4.4, p = 0.03) as an independent predictor of PE occurrence. Similarly, female gender (OR = 2, CI: 1.06-3.84, p = 0.03) as well as general anesthesia (GA, OR = 2.23, CI: 1.13-4.63, p = 0.02) and dose of unfractionated heparin per kilogram (UFH/kg, OR = 1.02, CI: 1-1.03 per 1 IU increment, p = 0.02) predicted the occurrence of a composite of major and minor bleeding. CONCLUSIONS: In this analysis, PS administration did not decrease the PE rate. Female gender predicted PE occurrence. Randomized, placebo-controlled trials are required to accurately assess the impact of PS.

Transcatheter aortic valve implantation in patients with bicuspid aortic valve stenosis utilizing the next-generation fully retrievable and repositionable valve system: mid-term results from a prospective multicentre registry.

BACKGROUND: The aim of this study was to evaluate the outcomes of transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BiAV) stenosis using a mechanically expanded Lotus™ device. The prior experience with first-generation devices showed disappointing results mainly due to increased prevalence of aortic regurgitation (AR) that exceeded those observed in tricuspid stenosis. METHODS AND RESULTS: We collected baseline, in-hospital, 30-day and 2-year follow-up data from a prospective, multicentre registry of patients with BiAV undergoing TAVI using Lotus™ valve. Safety and efficacy endpoints were assessed according to VARC-2 criteria. The study group comprised 24 patients. The mean age was 73.5 years and the mean EuroSCORE 2 was 4.35 ± 2.56%. MDCT analysis revealed Type 1 BiAV in 75% of patients. The mean gradient decreased from 60.1 ± 18.3 to 15 ± 6.4 mm Hg, the AVA increased from 0.6 ± 0.19 to 1.7 ± 0.21 cm2. One in-hospital death was observed secondary to aortic perforation. There was no severe AR and the rate of moderate AR equalled 9% at 30 days (n = 2). Device success was achieved in 83% and the 30-day safety endpoint was 17%. In the 2-year follow-up, the overall mortality was 12.5% and the 2-year composite clinical efficacy endpoint was met in 25% of the patients (n = 6) CONCLUSIONS: The TAVI in selected BiAV patients using the Lotus™ is feasible and characterized by encouraging valve performance and mid-term clinical outcomes.

Paradoxical low-flow aortic stenosis - baseline characteristics, impact on mortality.

INTRODUCTION: Paradoxical low-flow, low-gradient aortic stenosis (pLF-LGAS) constitutes an important part of the population undergoing transcatheter aortic valve implantation (TAVI). However, it remains the least defined subtype of aortic stenosis (AS). AIM: To investigate baseline characteristics and impact on mortality of pLF-LGAS in patients treated with TAVI. MATERIAL AND METHODS: Two-hundred and thirty-one consecutive patients (mean aortic valve area: 0.76 ±0.41 cm2) who underwent TAVI in our centre during the period of 6 years were included in the study. Based on echocardiographic examination, patients with pLF-LGAS were identified, analysed and compared to a population with high-gradient AS (HGAS) and low-flow, low-gradient AS with reduced ejection fraction (classical, cLF-LGAS). The primary endpoints of the study were all-cause mortality after 30 days and 1 year. RESULTS: pLF-LGAS was diagnosed in 42 (18.2%) patients, whereas 40 (17.3%) had cLF-LGAS and 149 (64.5%) had HGAS. The pLF-LGAS population was younger, had higher prevalence of hypertension, and had higher ejection fraction (EF) than the HGAS population, and had a smaller proportion of heavily symptomatic patients than the cLF-LGAS population. Overall, 46 (19.9%) patients died within 12 months after TAVI. The 30-day and 1-year survival was comparable between AS subtypes. Multivariate analysis identified severe renal failure as an independent predictor of mortality among all patients. CONCLUSIONS: pLF-LGAS is common among subjects undergoing TAVI. Patients with paradoxical AS are younger, more often burdened with hypertension and have higher EF than the HGAS population, while being less symptomatic than the cLF-LGAS group. Presence of pLF-LGAS does not seem to affect short- and mid-term survival. Severe renal failure is an independent predictor of mortality after TAVI.

Thromboelastography for predicting bleeding in patients with aortic stenosis treated with transcatheter aortic valve implantation.

BACKGROUND: Bleeding complications are frequent and independently impact mortality after transcatheter aortic valve implantation (TAVI). Thromboelastography (TEG) measures viscoelastic properties of clot formation and is currently best known for perioperative management to reduce blood transfusion in cardiac surgery. AIM: We sought to determine whether TEG may be predictive of bleeding in patients treated with TAVI. METHODS AND RESULTS: Overall, 54 consecutive patients with severe aortic stenosis treated with TAVI were prospectively included. In all patients, two blood samples were obtained for TEG measurement (the first - 12 h prior to procedure tested with citrated kaolin [CK] TEG assay, and the second - immediately after prosthesis deployment tested with CK and citrated heparinised kaolin assay [CHK]). Major or life-threatening bleeding (MLTB) was diagnosed in 13 (24%) patients. In receiver-operating characteristic (ROC) curve analysis the only TEG parameters showing significant sensitivity and specific-ity for predicting MLTB were those obtained in the CK sample at the end of the procedure: R value (reaction time, time to initiation of clot formation) area under the curve (AUC) 0.69, 95% confidence interval (CI) 0.49-0.88, p = 0.04; angle (the rate of clot formation), AUC 0.75, 95% CI 0.59-0.92, p = 0.007, and maximum amplitude (MA, ultimate strength of fibrin clot), AUC 0.77, 95% CI 0.62-0.93, p = 0.003. After controlling for confounding factors on multivariate logistic regression, MA remained as the only TEG parameter that significantly correlated with bleeding after TAVI, both as a continuous variable (p = 0.004; 95% CI 0.92-0.98; odds ratio [OR] 0.95 per 1 mm increment) and after using the cut-off value derived from ROC analysis; MA < 46.6 mm (OR 10.4; 95% CI 2.1-51.8; p = 0.004). CONCLUSIONS: Low strength of fibrin clot measured by TEG immediately after TAVI may serve as an independent predictor of short-term major and life-threatening bleeding complications.

Patient-prosthesis mismatch in patients treated with transcatheter aortic valve implantation - predictors, incidence and impact on clinical efficacy. A preliminary study.

INTRODUCTION: Patient-prosthesis mismatch (PPM) is relatively frequent after surgical aortic valve replacement (SAVR) and negatively impacts prognosis. AIM: We sought to determine the frequency and clinical effects of PPM after transcatheter aortic valve implantation (TAVI). MATERIAL AND METHODS: Overall, 238 patients who underwent TAVI were screened. Moderate PPM was defined as indexed effective orifice area (EOAi) between 0.65 and 0.85 cm2/m2, and severe PPM as < 0.65 cm2/m2. All-cause mortality and the Valve Academic Research Consortium 2 (VARC-2) defined composite of clinical efficacy at 1 year were the primary endpoints. RESULTS: Finally, 201 patients were included (mean age: 79.6 ±7.4 years, 52% females). The femoral artery served as the delivery route in 79% and most of the prostheses were self-expanding (68%). Any PPM was present in 48 (24%) subjects, and only 7 (3.5%) had severe PPM. Body surface area (BSA) independently predicted any PPM (OR = 16.9, p < 0.001) whereas post-dilation tended to protect against PPM (OR = 0.46, p = 0.09). All-cause mortality was similar in patients with moderate or severe PPM as compared to those with no PPM (14.6% vs. 14.3% vs. 13.1%, respectively, log-rank p = 0.98). Neither moderate (OR = 1.6, 95% CI: 0.8-3.2, p = 0.16) nor severe PPM (OR = 1.67, 95% CI: 0.36-7.7, p = 0.51) had a significant impact on composite endpoint, or its elements, with the exception of transvalvular pressure gradient > 20 mm Hg. CONCLUSIONS: Severe PPM after TAVI is rare, can be predicted by larger BSA and does not seem to affect mid-term mortality or composite clinical outcome. Larger studies are needed to find different independent predictors of PPM and elucidate its impact in terms of device durability and long-term clinical efficacy.

Left ventricular remodelling pattern and its relation to clinical outcomes in patients with severe aortic stenosis treated with transcatheter aortic valve implantation.

INTRODUCTION: Left ventricular hypertrophy (LVH) is a common compensating process in the pressure overload mechanism of aortic stenosis (AS). AIM: To identify a group of patients with a LVH pattern which may alter periprocedural and 1-year outcomes after transcatheter aortic valve implantation (TAVI). MATERIAL AND METHODS: Echocardiographic examinations of 226 patients with severe AS treated with TAVI between March 2010 and February 2016 were retrospectively analysed and correlated with echocardiographic parameters and clinical outcomes in the study group. Ultimately 208 patients were enrolled in the study. Based on left ventricular mass index (LVMI) and relative wall thickness (RWT) patients were divided into three categories: concentric remodelling (CR), concentric hypertrophy (CH) and eccentric hypertrophy (EH). Most of the patients with severe AS referred for TAVI were found to have CH (n = 150, 72.8%), then EH (n = 33, 16%) and CR (n = 16, 7.8%). RESULTS: There were no significant differences between groups in terms of periprocedural outcomes or complications. After a mean observation time of 561.8 ±239.0 days, the observed all-cause mortality rate was 19.9%. After multivariable adjustment, CR remained associated with a higher risk of mortality (HR = 4.31; 95% CI: 1.607-11.538; p = 0.004). CONCLUSIONS: Left ventricular hypertrophy is common in patients with severe AS prior to TAVI. The LVH pattern does not affect TAVI-related complications. In patients with severe AS referred for TAVI, CR seems to be the least favourable geometry of LVH, increasing the risk of 1-year all-cause death.

Platelet distribution width predicts left ventricular dysfunction in patients with acute coronary syndromes treated with percutaneous coronary intervention.

BACKGROUND: The role of platelets in the pathophysiology of acute coronary syndromes (ACS) is undeniable, but precise relationships between platelet activity and treatment outcomes are a matter of continuant investigation. Among platelet indices, mean platelet volume (MPV) has proven to be a valuable predicting factor in cardiac patients. However, platelet distribution width (PDW) is reported to be a more specific marker of platelet reactivity. Thus, application of PDW in risk stratification of ACS treatment is an up-to-date subject of research. PDW values in the assessment of left ventricular (LV) function have not been previously studied. AIM: The aim of the study was to evaluate whether admission PDW can predict LV systolic function in patients with ACS treated with stent implantation. METHODS: On-admission PDW was measured in 278 consecutive patients with diagnosis of ACS, who underwent stent(s) implantation. Echocardiogram with LV ejection fraction (LVEF) estimation was performed within 24 h of percutaneous coronary intervention. Additionally, patients were under one-year follow-up, and one-year all-cause mortality was assessed. RESULTS: According to receiver-operating characteristics (ROC) analysis, a PDW value greater than 12.8 fL could predict LVEF ≤ 35% with sensitivity of 81% and specificity of 39% (AUC 0.614; p = 0.0177). Only a trend was noted in ROC for PDW and one-year mortality (AUC 0.608; p = 0.0815). Multivariate logistic regression analysis has shown that the PDW parameter correlates independently with both systolic heart failure with LVEF ≤ 35% (PDW cut-off: 12.8 fL, OR 2.8107, CI 1.1401-6.9293, p = 0.0248) and one-year mortality (PDW cut-off: 16 fL, OR 2.6750, CI 1.0190-7.0225, p = 0.0457). CONCLUSIONS: Admission PDW may serve as a simple and widely available predictor of impaired LV function in patients with ACS. Association between PDW and mortality needs to be confirmed in larger studies.

Outcome prediction following transcatheter aortic valve implantation: Multiple risk scores comparison.

BACKGROUND: The aim of the study was to compare 7 available risk models in the prediction of 30-day mortality following transcatheter aortic valve implantation (TAVI). Heart team decision supported by different risk score calculations is advisable to estimate the individual procedural risk before TAVI. METHODS: One hundred and fifty-six consecutive patients (n = 156, 48% female, mean age 80.03 ± 8.18 years) who underwent TAVI between March 2010 and October 2014 were in-cluded in the study. Thirty-day follow-up was performed and available in each patient. Base-line risk was calculated according to EuroSCORE I, EuroSCORE II, STS, ACEF, Ambler's, OBSERVANT and SURTAVI scores. RESULTS: In receiver operating characteristics analysis, neither of the investigated scales was able to distinguish between patients with or without an endpoint with areas under the curve (AUC) not exceeding 0.6, as follows: EuroSCORE I, AUC 0.55; 95% confidence intervals (CI) 0.47-0.63, p = 0.59; EuroSCORE II, AUC 0.59; 95% CI 0.51-0.67, p = 0.23; STS, AUC 0.55; 95% CI 0.47-0.63, p = 0.52; ACEF, AUC 0.54; 95% CI 0.46-0.62, p = 0.69; Ambler's, AUC 0.54; 95% CI 0.46-0.62, p = 0.70; OBSERVANT, AUC 0.597; 95% CI 0.52-0.67, p = 0.21; SURTAVI, AUC 0.535; 95% CI 0.45-0.62, p = 0.65. SURTAVI model was calibrated best in high-risk patients showing coherence between expected and observed mortality (10.8% vs. 9.4%, p = 0.982). ACEF demonstrated best classification accuracy (17.5% vs. 6.9%, p = 0.053, observed mortality in high vs. non-high-risk cohort, respectively). CONCLUSIONS: None of the investigated risk scales proved to be optimal in predicting 30-day mortality in unselected, real-life population with aortic stenosis referred to TAVI. This data supports primary role of heart team in decision process of selecting patients for TAVI.