Underwent Transcatheter Aortic Valve Implantation Procedure Research Articles

Echocardiographic and clinical features of patients developing prosthesis-patient mismatch after TAVI: insights from an international multicenter registry

Abstract Background The impact of prosthesis-patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI) is controversial. Purpose Our study aims to evaluate the impact of PPM on mortality and clinical-echocardiographic progression of cardiac damage in a "real world" cohort of patients at intermediate and low surgical risk and to characterize its main predictors. Methods 963 patients who underwent TAVI procedure between 2017 and 2021, from an international multicenter observational registry, were included in this analysis. Multiparametric echocardiographic data were analyzed at 1-year follow-up (FU). Clinical and echocardiographic features were stratified by presence of PPM and PPM severity, as per the most current international recommendations (VARC-3 criteria). Results 18% of patients developed post-TAVI PPM, (7.7% of the whole cohort severe). At baseline, 50.3% of patients with PPM were male (vs 46.2% in the cohort without PPM, p=0.33), aged 82y (interquartile range (IQR) 79-85y) vs 82y (IQR 78-86y; p=0.46), and 55.6% had Balloon-Expandable valves implanted (vs 46.8% of patients without PPM, p=0.04); they had smaller left ventricular outflow tract (LVOT) diameter (20mm, IQR 19-21 vs 20mm, IQR 20-22, p=0.02), reduced Stroke Volume index (SVi) (34.2 vs 38 ml/m2, p<0.01) and transaortic flow rate (190.6 vs 211 ml/s, p<0.01). At pre-discharge FU patients with PPM had more paravalvular aortic regurgitation (AR) (moderate/severe AR 15.8% vs 9.2%, p<0.01). At a median FU of 1.46 years (IQR 1-4), there was no evidence of a significant impact of PPM on overall mortality (15.3% vs 13.1%, p=0.46) nor on rehospitalization rate for heart failure (4.3% vs 8.0%, p=0.10). At 1-year FU, maladaptive alterations of left ventricular parameters were found in patients with PPM, with a significant increase in endsystolic diameter (ESD) (33 vs 28mm, p=0.03) and a statistically non-significant increase in LV mass index (121 vs 106g/m2, p=0.07). Interestingly, trajectory parameters of patients with PPM from baseline to 1-year FU showed a reduced cardiac remodeling compared to patients without PPM, including no LVEF improvement (p=0.88), absent reduction of LV end-diastolic volume (p=0.70), indexed LV mass (p=0.31), ESD (p=0.48) and pulmonary artery systolic pressure (p=0.82), and an increase of basal RV diameter (p<0.001). Patients with moderate/severe PPM had worse NYHA functional class at 1 year (NYHA III-IV 13% vs 7.8%, p=0.03). Independent predictor of PPM at multivariable logistic regression was male gender (OR=1.93, p=0.04); while SVi (OR=0.86, p<0.001), prosthetic size >23mm (OR=0.62, p=0.03) and LVOT diameter (OR=0.79, p=0.02) had protective effect. Conclusions There was no evidence of a short- or medium-term impact of PPM on mortality. However, clinical-echocardiographic evaluations demonstrated a PPM-related pattern of early ventricular maladaptive alterations associated with a significant deterioration in NYHA class at 1 year.

Cardiac output in patients with small annuli undergoing transcatheter aortic valve implantation with self-expanding versus balloon expandable valve (COPS-TAVI)

BackgroundThere is limited data on cardiac output in patients with small aortic annuli undergoing trans-catheter aortic valve implantation (TAVI) according to the implanted platform of balloon-expandable (BEV) compared to self-expanding valves (SEV). MethodsThis is a retrospective analysis of consecutive patients with severe aortic stenosis and small annuli who underwent successful TAVI. Cardiac output was measured using echocardiography within 4 weeks following TAVI. Data were recorded and analysed by an experienced operator who was not aware of the type of the implanted valve. Results138 patients were included in the analysis, of whom 57 % underwent TAVI with BEV. Clinical and echocardiographic characteristics were comparable between the two platforms, except for more frequent previous cardiac surgery and smaller indexed aortic valve in the BEV group. There was no relationship between computed tomography-derived aortic annulus area and cardiac output post TAVI. When compared to patients who underwent TAVI with BEV, those with SEV had larger cardiac output [mean difference − 0.50 l/min, 95 % CI (−0.99, −0.01)] and cardiac index [mean difference − 0.20 l/min/m2, 95 % CI (−0.47, 0.07)], although the latter did not reach statistical significance. Unlike patients with small body surface area, in those with large body surface area both cardiac output and cardiac index were statistically larger in patients who underwent SEV compared to BEV. ConclusionCardiac output, as measured by echocardiography, was larger in patients with small annuli who underwent TAVI procedure with SEV compared to BEV. Such difference was more evident in patients with large body surface area.

The Association between Blood Pressure and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation.

Transcatheter aortic valve implantation (TAVI) has emerged as a common and effective treatment for patients with severe aortic stenosis. Changes in systemic blood pressure after TAVI have been described, yet their prognostic value is not established. Thus, we aimed to examine the association of the periprocedural changes in systolic blood pressure (SBP) and in pulse pressure on clinical outcomes after the procedure. A retrospective study of consecutive patients who underwent TAVI procedure in our medical center. We assessed the effect of the periprocedural changes in blood pressure measurements on mortality, acute myocardial infarction, stroke and hospitalizations at 1 year and on the combined outcome of death, myocardial infarction, and stroke 1 year following the procedure. Our cohort included 455 patients (44% males). Of them, 343 patients (75.4%) had raised SBP immediately after the procedure. Patients with raised SBP had a significantly higher rate of the 1-year composite outcome, compared to patients who did not have a raise in SBP following the procedure (43 [13%] vs. 6 [5.4%], respectively, p = 0.033). After adjustment for age and sex, the postprocedural increase in SBP was significantly associated with the composite outcome, with a hazard ratio of 2.42, 95% CI: 1.03-5.7. An immediate increase in SBP after TAVI is associated with worse 1-year clinical cardiovascular outcomes.

EFFECTS OF HYPERTENSION ON TAVI OUTCOMES

Objective: Severe aortic stenosis (AS) is the most common valvular disease in elderly and transcatheter aortic valve implantation (TAVI) is the standard of care treatment for AS in patients with high surgical risk. Hypertension accompanies with AS in this population in general. We aimed to evaluate the impact of hypertension on TAVI related outcomes. Design and method: All of the patients who underwent TAVI procedure between January 2010 and March 2020 were screened and patients with eligible datas were included. Datas were obtained from hospital electronic database. Results: A total of 306 cases were enrolled. Mean age of the population was 76.0 ± 10.4 61.4% of the cases were female. Median follow-up was 28.4 (13.0-49.5) months. Age was significantly higher (77.0 ±8.2 vs. 72.7± 14.8; p = 0.018) and diabetes was more frequent (37.6% vs. 16.9%; p = 0.001) in hypertensive patients. Use of RAS blockers (62.0% vs 28.6%; p<0.001) and calcium channel blockers (34.5% vs. 3.9%; p<0.001) were more frequent in hypertensive cases as expected. Baseline characteristics and outcomes were summarized in Table-1. Left ventricular mass index was similar between the two groups (129.5 ± 32.8 vs. 132.7 ± 39.3; p = 0.502). Rates of contrast induced nephropathy, insertion site complications and need of de novo pacemaker implantation due to advanced heart block were not different between the two arms. Stroke rates were distinctly higher in patients with hypertension (7.4% vs 0%; p = 0.009), while all-cause mortality during follow-up was similar between patients with and without hypertension. Conclusions: Left ventricular mass index increases in patients with severe AS and hypertension also leads left ventricular hypertrophy by raising afterload. However, LVMI values were similar between patients with and without hypertension contrary to as expected. Higher proportion of RAS blocker use that has favorable effects on cardiac remodelling can explain this finding. Significantly increased risk of stroke in patients with hypertension is another attractive finding that should be kept in mind.

Aortic valve and vascular calcium score in pre-TAVI CT: correlation with early post-procedural complications

PurposeThe aim of our study was to evaluate the prevalence of early complications after Transcatheter Aortic Valve Implantation (TAVI) and their correlation with the Calcium Score (CS) of the aortic valve, aorta and ilio-femoral arteries derived from pre-procedural computed tomography (CT).Materials and methodsWe retrospectively reviewed 226 patients (100 males, mean age 79.4 ± 6.7 years) undergoing 64-slice CT for pre-TAVI evaluation from January 2018 to April 2021. The population was divided into CS quartiles.ResultsOverall, 173 patients underwent TAVI procedure, of whom 61% presented paravalvular leak after the procedure, 28% presented bleeding or vascular complications, 25% presented atrioventricular block, and 8% developed acute kidney injury. The prevalence of paravalvular leak and vascular complications was higher in the upper CS quartiles for aortic valve and ilio-femoral arteries.ConclusionsAortic valve and vascular CS could help to predict post-TAVI early complications.

Impact of mitral valve regurgitation severity on clinical outcomes in patients with severe aortic stenosis undergoing TAVI

Abstract Background Significant mitral regurgitation (MR) is among the most common cardiac diseases associated with severe aortic stenosis (AS). It is frequently caused or exacerbated by increased left ventricular diastolic pressure and/or diameter, with consequent stretching of the mitral annulus and reduction of leaflet coaptation. Transcatheter aortic valve implantation (TAVI) has been established as an alternative treatment in patients with severe AS, with a prevalence of MR that ranges from 3–37%, but in this setting is typically left untreated. Prognostic clinical impact of concomitant MR in patients undergoing TAVI on outcomes is not clear and conflicting results have been reported. Purpose We sought to investigate the clinical impact of significant MR (≥2+) on mortality at 1-year follow-up in a group of patients with severe aortic stenosis that underwent TAVI procedure. Secondary objective was to evaluate the rate of re-hospitalization during that time. Methods From July 2010 to December 2019 information was gathered from a total 400 patients with severe aortic stenosis who underwent successful TAVI procedure at a University Hospital. We performed a monocentric, non-randomized, observational and prospective study that evaluated clinical outcomes following TAVI in patients with severe aortic stenosis and significant MR (≥2+; Group A) compared to those with mild or absent MR (<2+; Group B). The primary end point was the percentage of all-cause mortality at 1-year follow-up. Secondary end point was the rate of re-hospitalization following TAVI procedure at 1-year follow-up. Results The mean age of the global population (n=400) was 83±7 years and 243 were females (60.7%). Among the total sample, 72 (18%) patients had baseline moderate to severe MR (Group A) and were compared to the remaining 328 patients with mild or absent MR (Group B). At one-year follow-up, we observed a statistically significant higher all-cause mortality in 10 (22.3%) patients from Group A compared to 10 (6.7%) in Group B (p=0.05). The rate of re-hospitalization was significantly higher (p=0.01), occurring in 38.8% (85) of patients in Group A compared to 25.9% (28) in Group B. Conclusion Baseline significant MR (≥2+) in patients with severe aortic stenosis that underwent TAVI was associated with higher all-cause mortality and re-hospitalization at 1-year follow-up. To date, it is not clear whether this association is related to MR severity or if is simply a marker of worst prognosis. Further studies are warranted to reproduce these results. Funding Acknowledgement Type of funding sources: None. Kaplan-Meier estimates of survival

Improvement in Vascular Endothelial Function following Transcatheter Aortic Valve Implantation.

Background and objectives: Endothelial dysfunction is associated with exercise intolerance and adverse cardiovascular events. Transcatheter aortic valve implantation (TAVI) is applied to treat elderly patients with severe aortic stenosis, but less is known about the impact of TAVI on endothelial dysfunction, which can be assessed by measuring flow-mediated vasodilation (FMD). In this parameter, a low value indicates impaired endothelial function. Materials and Methods: Vascular endothelial function was evaluated by FMD of the brachial artery just before and one week after TAVI. Factors associated with the normalization of FMD and their prognostic impact were investigated. Results: Fifty-one patients who underwent TAVI procedure (median 86 years old, 12 men) were included. FMD improved significantly from baseline to one week following TAVI (from 5.3% [3.7%, 6.7%] to 6.3% [4.7%, 8.1%], p < 0.001). Among 33 patients with baseline low FMD (≤6.0%), FMD normalized up to >6.0% following TAVI in 15 patients. Baseline higher cardiac index was independently associated with normalization of FMD following TAVI (odds ratio 11.8, 95% confidence interval 1.12–124; p < 0.04). Conclusions: Endothelial dysfunction improved following TAVI in many patients with severe aortic stenosis. The implication of this finding is the next concern.

Comparison of anesthesia management in transcatheter aortic valve implantation: a retrospective cohort study

Background and objectivesWe aimed to investigate the effects of two different anesthetic techniques in our patients who underwent transcatheter aortic valve implantation (TAVI). MethodsIn this study, 303 patients who underwent TAVI procedure with a diagnosis of severe aortic stenosis between January 1, 2012 and December 31, 2018 were retrospectively evaluated. The patients were divided according to the type of anesthesia given during each procedure as; general anesthesia (GA), local anesthesia (LA). ResultsLA was preferred in 245 (80.8%) of 303 patients who underwent TAVI, while GA was preferred in 58 patients (19.1%). Median ages ​​of our patients who received LA and GA were 83 and 84, respectively. The procedure and anesthesia durations of the patients in the GA group were longer than the LA group (p< 0.00001, p < 0.00001, respectively). Demographic and pre-operative clinical data were similar in comparison between two groups (p > 0.05) except for peripheral artery disease. Hypertension was the most common comorbidity in both groups. While the number of inotrope use was significantly higher in patients who received GA (p < 0.00001), no significant differences were found between LA and GA patients in terms of major complications and mortality (p > 0.05). Intensive care and hospital stays were significantly shorter in the LA group (p = 0.001, p = 0.023, respectively). ConclusionThe anesthetic technique of TAVI procedure did not have a significant effect on outcomes including; complications, mortality and success of the procedure. LA provides shorter duration of procedure and hospital stay.

Predictors of Mitral Regurgitation Severity Improvement in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.

BackgroundMitral regurgitation (MR) is frequently associated with severe aortic stenosis (AS). Significant MR is associated with less favorable prognosis after transcatheter aortic valve implantation (TAVI), including higher early and late mortality rate. The severity of MR is improved in about half of patients undergoing TAVI. However, the predictors of MR improvement after TAVI are unknown. We sought to investigate whether several demographic, clinical, echocardiographic and laboratory parameters and procedure characteristics are predictive of MR severity improvement after TAVI procedure.MethodsA total of 309 consecutive patients with severe symptomatic AS underwent TAVI procedure in our center from July 1, 2015 till December 31, 2019. The 85 patients had concomitant significant (grade 2 or 3) MR. We performed logistic regression analysis of age, sex, atrial fibrillation, left ventricular ejection fraction, end diastolic diameter, end systolic diameter, left atrial diameter, left atrial area, MR etiology (functional vs. degenerative), CHA2DS2-VASc score, pre-procedure B-type natriuretic peptide (BNP) levels and type of TAVI bioprosthesis as possible predictors of post-TAVI improvement of severity of MR.ResultsThe 35 patients have at least one grade reduction in the severity of MR in follow-up echo. None of the analyzed parameters were predicting of the MR severity improvement.ConclusionsIn this small single-center cohort study, we were unable to find any feasible demographic, clinical, echocardiographic or laboratory predictors of MR improvement after TAVI. There was no correlation between etiology of MR or type of TAVI bioprosthesis used and MR improvement.

Deterioration of peripheral microvascular tissue perfusion after transcatheter aortic valve implantation (TAVI) measured by 2D near-infrared spectroscopy (NIRS)

Abstract Background The data on the effect of transcatheter aortic valve implantation (TAVI) on peripheral microcirculation is scarce. Therefore, in this study, we investigate the changes of peripheral microvascular tissue perfusion before and after TAVI measured by a 2D near-infrared spectroscopy (NIRS) camera. NIRS allows measurement of hemoglobin oxygen saturation (StO2) in the blood perfusing the volume tissue under scrutiny. Methods In this prospective, single center study, patients with symptomatic, severe aortic stenosis either planned for elective TAVI procedure or elective cardiac catheterization were included. 2-D StO2 maps of all distal extremities (i.e. hand/foot) were acquired before and after TAVI by using a NIRS camera; macrovascular function of the tibial and forearm arteries was assessed by Doppler ultrasound with spectral analysis including ankle-brachial index (ABI) and applanation tonometry. Results 26 subjects (19 male, age 83±6 years) undergoing TAVI procedure and 5 subjects (4 male, age 76±10) undergoing cardiac catheterization were included in this trial. In the group undergoing TAVI procedure, 5 patients had diabetes mellitus (19%), one of whom was insulin-dependent, 3 patients had a history of peripheral artery disease (12%) and 1 patient had a history of smoking (4%). TAVI procedure was successful without major complications in all cases.Mean peripheral StO2 decreased significantly on all extremities after TAVI, i.e. right hand (from 71±14% to 61±16%; p=0.01), left hand (from 70±12 to 62±16%; p=0.03), right foot (from 70±11% to 61±15%; p&amp;lt;0.01) and left foot (from 66±15% to 58±14%; p=0.03). ABI did not change after TAVI (right ABI baseline mean 1.08±0.2; Δ0.06; left ABI baseline 1.05; Δ0.05). Macrovascular function of the forearm and tibial arteries did not deteriorate as measured by Doppler ultrasound. Furthermore, aortic mean pressure (from 108±21 mmHg to 87±13 mmHg; p=0.002) and augmentation index (from 34±8 mmHg to 24±8 mmHg; p&amp;lt;0.001) decreased significantly while subendocardial viability ratio (from 128±22 to 147±7; p&amp;lt;0.001), a marker for coronary microvascular function, improved significantly after TAVI. In the group undergoing cardiac catheterization, there were no statistically significant changes in macro- or microvascular function. Conclusion This is, to our knowledge, the first study investigating the effect of peripheral microvascular tissue perfusion measured by NIRS after TAVI. Our results show that peripheral microvascular tissue perfusion was significantly deteriorated after TAVI procedure. StO2 before and after TAVI procedure Funding Acknowledgement Type of funding source: None

Short term improvement of global left ventricular longitudinal strain by speckle tracking echocardiography after transcatheter aortic valve implantation in patients with severe aortic stenosis

Abstract Background Global longitudinal strain (GLS) has incremental value in assessing left ventricular (LV) function in patients with severe aortic stenosis (AS). Long-standing AS causes LV hypertrophy which predisposes to increased cardiac morbidity and mortality. The recent development of transcatheter aortic valve implantation (TAVI) device for treatment of severe symptomatic AS, offers an option for high risk patients. Objectives Our aim was to investigate the correlation between the time elapsed after performing a TAVI procedure and the LV GLS by Speckle tracking echocardiography (STE) and its correlation with progressive degree of regression in LV mass (LVM) by transthoracic echocardiography (TTE). Methods TTE was performed on 54 patients with severe AS who underwent TAVI procedure. TTE was performed at baseline (before the procedure) and then at 3 months and 6 months post TAVI. GLS was calculated for every patient from STE of the three apical views (apical 4, apical 2 and apical long axis views). The LV muscle volume was calculated by subtraction of LV pericardial volume from LV endocardial volume using biplane Simpson's formula. LVM was then calculated by multiplying LV mass volume by muscle density (1.05). Results The study included 54 patients with severe AS (average PG =79.5 mmHg and average mean gradient 40.5 mmHg), with a mean age of 79±10 years and 46 were male. All patients underwent TAVI and average mean gradient post TAVI was 7 mmHg. The mean ± SD of GLS were −15.3±2.0, −15.9±1.7 and −17.2±1.8 for STE obtained at baseline, 3- and 6-months post TAVI, respectively. There was significant difference in LV GLS when comparing baseline measurements with measurements obtained at both 3 months {mean difference ± SD (MD±SD) was 0.57±0.7 (p&amp;lt;0.001)} and at 6 months post TAVI was 1.8±0.8 (p&amp;lt;0.0001). There was significant difference when comparing LV GLS measurements at 3- and 6- months post TAVI MD±SD was 1.2±0.65 (p&amp;lt;0.001). The mean±SD of LVM was 118.5±31, 110.5±29.2 and 101.1±26.4 at baseline, 3- and 6-months post TAVI, respectively. There was significant difference between baseline and 3 months measurement of LVM, MD±SD is 7.6±6.0 (p&amp;lt;0.001). There was significant difference between baseline and 6 months measurement of LVM, MD±SD was 17.0±10.5 (p&amp;lt;0.0001). In addition, there was significant difference of LVM calculation at 3 and 6 months with MD±SD of 9.4±7.9 and (P&amp;lt;0.001). Conclusions In patient with severe AS that underwent TAVI, there is short term continues significant improvement of LV GLS by STE. This could be attributed to relieving the pressure overload and regression of LVM over time. Decreasing LV hypertrophy and increasing LV GLS on the short term indicate high efficacy of TAVI procedure and subsequently improving patient prognosis and quality of life. Funding Acknowledgement Type of funding source: None

Transapical Transcatheter Aortic Valve Implantation in Ukraine: Primary Experience in XPand Device Usage

Background. Recent developments in the field of transcatheter aortic valve implantation (TAVI) have led to arised interest for the optimization of this procedure and related devices for patients with severe aortic valve stenosis. This is the first study to examine novel XPand device, jointly developed by German, French and Ukrainian scientists. This study aims to contribute to this growing area of research by exploring efficacy and safety in patients with severe aortic stenosis. Objective. To evaluate the procedure effectiveness and long-term outcomes for XPand device implantation in patients with severe aortic valve stenosis. Materials and methods. We initiated a single-center clinical trial to evaluate the XPand device and already perform an initial analysis of the primary outcomes. After patients fitted the inclusion criteria full examination they underwent TAVI procedure using the XPand system. Postoperative result evaluation was performed according to the established protocol. Outcomes. Primary good results for TAVI XPand were obtained in all patients (n = 7). The average length of stay in the hospital after the procedure was 20 ± 1.25 days. The postoperative period was unremarkable. In 71.5% of patients the minimal paravalvular insufficiency or insufficiency absence were obtained after the final aortography. Comments. The first experience of using modern device XPand for transcatheter implantation of the aortic valve prosthesis confirms its effectiveness and safety in patients with severe aortic stenosis.

P3722Platelet reactivity changes following transcatheter aortic valve implantation

Abstract Introduction Although recent studies described changes in platelet reactivity (PR) in days following transcatheter aortic valve implantation (TAVI), precise time course and duration of these changes have not been fully investigated. Purpose To investigate PR changes during and after TAVI. Methods Study included 42 consecutive patients with severe and symptomatic aortic stenosis undergoing TAVI procedure in our institution. Patients' clinical characteristics were collected from medical records. All patients who did not have chronic dual antiplatelet therapy received loading dose of aspirin and clopidogrel (300 mg) one day before the procedure followed by their standard maintenance doses for next three months. PR was measured in six time points: just before induction of anaesthesia (T1), after heparin administration (T2), at the end of procedure (T3), and on 3rd, 6th and 30th postoperative day (T4–6). PR was measured using impedance aggregometer (Multiplate® analyzer, Roche, Munich, Germany) in response to three platelet aggregation agonists: arachidonic acid (ASPItest), ADP (ADPtest) and thrombin receptor activating peptide-6 (TRAPtest). Results Mean patient age was 82.1 years with majority of patients being male 57.1% (N=24). Mean valve area and mean transvalvular gradient prior to procedure were 0.71±0.21 cm2 and 49.1±18.7 mmHg, respectively. All patients underwent successful TAVI procedure using either self-expandable (N=25, 59.5%) or balloon-expandable valve. Two patients (4.7%) underwent transapical TAVI, while transfemoral approach was used in all other patients. Mean postimplantation gradient was 10.2±7.1 mmHg. Mean PR on T1 was 24.3±23.1 U for ASPItest, 41.6±26.5 U for ADPtest and 90.1±33.3 U for TRAPtest. There was no significant difference in PR on T2. However, on T3, ignificant reduction of PR in all 3 tests was observed (ASPI 9.4±10.1 U (p=0.001), ADP 23.1±15.0 U (p&lt;0.001) and TRAP 64.5±27.3 U (p&lt;0.001)). Lowest PR values for all tests were reached on T4, after which incline in PR has been observed. On T5, value of ASPItest reached levels not significantly different to those on T1 (15.1±17.2 U, p=0.13), while ADPtest and TRAPtest remained significantly lower (27.3±18.5 U, p=0.007 and 68.6±33.2 U, p=0.003, respectively). All PR values returned to initial levels on T6 (figure 1). Conclusions Our results show that successful TAVI procedure induces transient decrease in PR regardless of the platelet activation pathway. These findings add new knowledge in understanding complexed relations in intravascular milieu following TAVI. Further research on a larger number of patients is needed to confirm and asses clinical significance of these results. Acknowledgement/Funding Croatian Science Foundation

An alternative solution for patient with high risk of coronary obstruction underwent TAVI procedure using a novel second-generation device \u2013 a case series

BackgroundObstruction of the left or right coronary artery is a rare but lethal complication during transcatheter aortic valve implantation (TAVI). The new J-Valve™ prosthesis is a new second generation TAVI device which has several features to avoid the coronary obstruction such as low profile design and clip fixation of the native leaflets. The aim of this study is to report our initial experience of using this valve in treating patient with high risk factors for coronary obstruction during TAVI procedure.Case presentationThree high surgical risk patients (All females with 77, 76, and 75 years old) with symptomatic aortic stenosis were enrolled. All patients have the common feature of low coronary ostium height (< 10 mm) with narrowed aortic sinus (< 30 mm) on CT angiogram and marked leaflet calcification. Three 25 mm J-Valve prostheses were successfully implanted through trans-apical approach. No coronary obstruction was noted for these patients. Effective aortic open area was significantly increased after valve implantation (Preoperative 0.7, 0.7 and 0.65 cm2 – Postoperative 1.8, 1.9 and 2.0 cm2). Only one patient was noted to have trivial degree paravalvular leakage.ConclusionThe new J-Valve prosthesis is a new second generation TAVI device. This system may provide another safety treatment option for patient with high risk factor for coronary obstruction underwent TAVI procedure.

Safety and Efficacy of Pressure Regulated Deployment of Balloon-expandable Transcatheter Aortic Valve Implantation (TAVI)

Introduction: Currently no optimal strategy exists for deployment of balloon-expandable transcatheter aortic valves. Prosthesis oversizing is associated with the devastating complication of aortic annular rupture as well as increased post-procedural atrioventricular conduction disease. Conversely, valve undersizing is associated with greater paravalvular regurgitation and poor long-term outcomes. We propose a novel pressure regulated deployment strategy that enables optimal apposition between prosthesis and annulus while also carefully preventing significant annular overstretching and injury. Methods: 251 consecutive patients underwent TAVI procedure with balloon-expandable valves across two Australian centres. Prosthesis sizing was determined using device manufacturer and previously published charts. In all patients the valve prosthesis was deployed using a pressure regulated expansion strategy. Following initial deployment, an additional intraprocedural post-dilatation with Balloon Aortic Valvuloplasty was occasionally performed to reduce paravalvular leak. 41 patients underwent prosthesis implantation that would have otherwise resulted in >20% oversizing by traditional volume expansion. For this group the deployment pressure was limited to 5.5 atm. Results: No cases of aortic annular rupture occurred and overall rates of PPM insertion and development of new LBBB were 6.3% and 12.2%, respectively. There was no significant association between the degree of valve oversizing and sustained postprocedural conduction disease. However, there was a strongly significant inverse relationship between valve oversizing and resulting paravalvular leak. Higher deployment pressures resulted in fewer post-dilatation BAV. Conclusion: Pressure regulated deployment of transcatheter aortic balloon-expandable valves is a safe and efficacious strategy.

Insulin like growth factor binding protein 2 (IGFBP-2) for risk prediction in patients with severe aortic stenosis undergoing Transcatheter Aortic Valve Implantation (TAVI)

IntroductionSevere aortic stenosis (AS) caused by degenerative calcification is the most frequent acquired valvular heart disease worldwide and mortality rates are considerably high. Transcatheter Aortic Valve Implantation (TAVI) is a well-established method for valve replacement in high risk patients with AS. However, there is a lack of reliable predictors for patients undergoing TAVI since commonly used scores were developed for surgical populations. Materials and methods208 patients subjected to TAVI were included in this study. Plasma samples were obtained before TAVI and were evaluated for IGFBP-2 using commercially available ELISA kits. IGFBP-2 levels were analyzed for their ability for risk prediction after TAVI. ResultsIGFBP-2 levels measured before TAVI correlated significantly with left ventricular ejection fraction, EUROSCORE and other functional and prognostic parameters like the 6-minute walking test. When patients were retrospectively divided in two groups with a cut-off of serum IGFBP-2 levels of 275 ng/ml, IGFBP-2 was a strong predictor for 30-day and one-year mortality (3% vs. 11%, p = 0.05 and 18.2% vs. 46.2%; p < 0.001 respectively). Compared to an EUROSCORE above 20 or an STS score cut-off above 8, IGFBP-2 plasma levels above 275 ng/ml outperformed the established risk score for prediction of one-year mortality as assessed by NRI (0.65 95% CI 0.37–0.94; p < 0.001 and 0.54 95% CI 0.25–0.82; p < 0.001, respectively). ConclusionsOur results indicate that IGFBP-2 could serve as new outcome predictor for patients undergoing TAVI procedure. By providing additional information to the commonly used EUROSCORE, IGFPB-2 analysis could further assist Heart Team decision making.

Transapical Transcatheter Aortic Valve Implantation Using a New TAVI System for High-Risk Patients With Severe Aortic Stenosis

To evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) for high-risk patients with aortic stenosis using the J-Valve system. 30 high-risk patients with severe AS underwent TAVI procedure were enrolled with mean age 74.5±4.5 years and mean logistic Euro-SCORE-I of 28.4±9.6%. All patients were followed up for 6 months. Outcomes were analysed in accordance with the updated standardised endpoints defined by the Valve Academic Research Consortium -2 (VRAC-2) criteria. VARC-2 defined device success was obtained in 93% (28 of 30 patients). No operative mortality was noted. No major complications such as third-degree AV-block, myocardium infraction or cerebrovascular events were noted during procedure and follow-up. Transvalvular PG was decreased at 6 months compared with preoperative state (PG mean: 55.4±14.9 vs 14.6±6.9mmHg p<0.01). No moderate or above degree paravalvular leakage (PVL) was noted. All patients with successful valve implantation were alive with improved exercise tolerance. Our initial result has demonstrated that the J-Valve system has the potential to become a feasible treatment option for high-risk patients with severe AS.

Using a multidimensional prognostic index (MPI) based on comprehensive geriatric assessment (CGA) to predict mortality in elderly undergoing transcatheter aortic valve implantation

BackgroundSelection of appropriate elderly who can benefit from transcatheter aortic valve implantation (TAVI) is challenging. We evaluated the prognosis of this procedure according to the comprehensive geriatric assessment (CGA) based on the multidimensional prognostic index (MPI). MethodsProspective observational monocentric study from January 2013 to December 2015. Consecutive patients aged ≥75 who underwent TAVI and a complete CGA were included. Baseline demographic, geriatric and cardiologic data were collected. CGA was used to calculate the MPI score that is divided in three groups according to the mortality risk. Follow up was performed until December 2016 and mortality rate was assessed at one, six and 12months. Results116 patients were included. Mean age was 86.2±4.2years, mean European system for cardiac operative risk evaluation (EuroSCORE) was 19.2±11.3%, mean MPI score was 0.39±0.13. Forty-five (38.8%) patients belonged to MPI-1 group, 68 (58.6%) to MPI-2 group and three to MPI-3 group. MPI score and Euroscore were moderately correlated (Spearman correlation coefficient rs=0.27, p=0.0035). Mortality rate was significantly different between MPI groups at six and 12months (p=0.040 and p=0.022). Kaplan Meier survival estimates at one year stratified by MPI groups was significantly different (hazard ratio HR=2.83, 95%confidence interval (CI) 1.38–5.82, p=0.004). Among variables retained to perform logistic regression analysis, the score of instrumental activities of daily living appeared the most relevant (p<0.001). ConclusionThis study indicates that CGA based on MPI tool is accurate to predict prognosis in elderly patients undergoing TAVI procedure.

Prognostic value of the ratio between prosthesis area and indexed annulus area measured by MultiSlice-CT for transcatheter aortic valve implantation procedures.

BackgroundPostprocedural aortic regurgitations following transcatheter aortic valve implantation (TAVI) procedures remain an issue. Benefit of oversizing strategies to prevent them isn't well established. We compared different level of oversizing in our cohort of consecutive patients to address if severe oversizing compared to normal sizing had an impact on post-procedural outcomes.MethodsFrom January 2010 to August 2013, consecutive patients were referred for TAVI with preoperative Multislice-CT (MSCT) and the procedures were achieved using Edwards Sapien® or Corevalve devices®. Retrospectively, according to pre-procedural MSCT and the valve size, patients were classified into three groups: normal, moderate and severe oversizing; depending on the ratio between the prosthesis area and the annulus area indexed and measured on MSCT. Main endpoint was mid-term mortality and secondary endpoints were the Valve Academic Research Consortium (VARC-2) endpoints.ResultsTwo hundred and sixty eight patients had a MSCT and underwent TAVI procedure, with mainly Corevalve®. While all-cause and cardiovascular mortality rates were similar in all groups, post-procedural new pacemaker (PM) implantation rate was significantly higher in the severe oversizing group (P = 0.03), while we observed more in-hospital congestive heart-failure (P = 0.02) in the normal sizing group. There was a trend toward more moderate to severe aortic regurgitation (AR) in the normal sizing group (P = 0.07).ConclusionsDespite a higher rate of PM implantation, oversizing based on this ratio reduces aortic leak with lower rates of post-procedural complications and a similar mid-term survival.

Microparticles in patients undergoing transcatheter aortic valve implantation (TAVI)

Degenerative aortic stenosis (AS) is the most frequent form of acquired valvular heart disease. AS is known to entail endothelial dysfunction caused by increased mechanical shear stress leading to elevated circulatory levels of microparticles. Endothelial and platelet microparticles (EMP and PMP) are small vesicles that originate from activated cells and thrombocytes. We sought to evaluate whether transcatheter aortic valve implantation (TAVI) procedure would elicit effects on circulating EMP and PMP. 92 patients undergoing TAVI procedure for severe AS were included in this study. Samples were obtained at each visit before TAVI, 1 week post-procedure and at 1, 3 and after 6 months after TAVI and were evaluated using flow cytometry. A 12 month clinical follow-up was also performed. CD62E+ EMP concentration before TAVI was 21.11 % (±6.6 % SD) and declined to 20.99 % (±6.8 % SD) after 1 week, to 16.63 % (±5.4 % SD, p < 0.0001) after 1 month, to 17.08 % (±4.6 % SD, p < 0.0001) after 3 months and to 15.94 % (±5.4 % SD, p < 0.0001) after 6 months. CD31+/CD42b−, CD31+/Annexin+/− EMP remained unchanged. CD31+/CD41b+ PMP evidenced a slight, but statistically significant increase after TAVI and remained elevated during the entire follow-up. Apart from a procedure-related improvement in echocardiographic parameters, TAVI procedure led also to a decline in CD62E+ EMP. The reduction in pressure gradients with less hemodynamic shear stress seems also to have beneficially affected endothelial homeostasis.