Outcomes Of Transcatheter Aortic Valve Implantation Research Articles

Insight on patient specific computer modeling of transcatheter aortic valve implantation in patients with bicuspid aortic valve disease

The aim of this study was to describe the early use of dedicated patient specific computer modeling in patients with bicuspid aortic valve (BAV) undergoing transcatheter aortic valve implantation (TAVI), in predicting procedure feasibility and patient related outcome. Dedicated patient specific computer modeling, used for optimizing TAVI procedures, is currently validated for the prediction of contact pressure, valve morphology and paravalvular leakage (PVL). The simulation of TAVI procedures is increasingly used in patients with tricuspid aortic valve stenosis. Currently, BAV disease is considered as a relative contra-indication for TAVI due to its specific anatomical characteristics. This single center study consisted of seven patients with BAV undergoing TAVI. A patient specific computer simulation was performed based on multislice computer tomography images. The model advised the best fitting prosthetic valve size or sizes and simulated this valve on different implantation depths with the corresponding presence and severity of PVL and prosthetic valve morphology. The simulation results were compared with the procedural outcomes using transesophageal echocardiography (TEE) and fluoroscopy. The patient specific computer modeling predicted accurately the outcome (PVL and valve morphology) of TAVI in all cases. In one case, the TAVI procedure was unsuccessful and retrospectively not suitable for TAVI, which was correctly predicted by the model. The patient specific computer modeling adequately predicts feasibility and outcome of TAVI in patients with BAV disease and may extend the applicability of TAVI. Moreover, it improves decision-making and therefore individual procedural outcomes in this difficult patient population.

Position paper of French Interventional Group (GACI) for TAVI in France in 2018

Aortic stenosis is a frequent disease in the elderly. Its prevalence is 0.4% with a sharp increase after the age of 65, and its outcome is very poor when the patient becomes symptomatic. The interventional procedure known as TAVI (trans-catheter aortic valve implantation), which was developed in France and carried out for the first time in Rouen by Prof. Alain Cribier and his team in 2002, has proven to be a valid alternative to surgical aortic valve replacement. At first, this technique was shown to be efficient in patients with contra-indications to surgical treatment or deemed to be at high surgical risk. Given the very promising outcomes achieved as a result of close heart team collaboration, appropriate patient selection, simplified procedures and reduced complication rates, transfemoral (TF) TAVI is now preferred in symptomatic intermediate risk patients>75 years old according to the latest ESC guidelines. In 2017, in France, TAVI is currently performed in 50 centers with on-site cardiac surgery. The 2016 TAVI outcomes recorded in the French national TAVI registry (France TAVI) are very encouraging and show that for 7133 patients treated (age 83.4±7 years, logistic Euroscore 14%), 87% of whom via the TF approach, cross-over to surgery was very low (0.5%) with a 3.0% in-hospital mortality rate. The substantial increase in TAVI indications and the improvement of its outcomes may in the near future call for a reconsideration of the number of high volume centers authorized to carry out this technique.

One-year outcomes of patients with severe aortic stenosis and an STS PROM of less than three percent in the SURTAVI trial

The indication for transcatheter aortic valve implantation (TAVI) has evolved from inoperable patients to patients at increased surgical risk. In low-risk patients, surgical aortic valve replacement (SAVR) remains the standard of care. The aim of this study was to explore the outcomes of TAVI and SAVR in patients with a Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) score below 3% in the SURTAVI trial. In SURTAVI, patients at intermediate surgical risk based on Heart Team consensus were randomised to TAVI or SAVR. We stratified the overall patient population into quintiles based on the STS PROM score; the one-year mortality was correlated with the mean STS PROM score in each quintile. The quintiles were regrouped into three clinically relevant categories of STS score: less than 3%, 3 to <5%, and >5%. All-cause mortality or disabling stroke in each risk stratum was compared between TAVI and SAVR. Linear regressions between mean values of STS PROM in each quintile and observed all-cause mortality at one year showed great association for the global population (r2=0.92), TAVI (r2=0.89) and SAVR cohorts (r2=0.73). All-cause mortality or disabling stroke of TAVI vs. SAVR was 1.5% vs. 6.5% (p=0.04), 6.5% vs. 7.6% (p=0.52) and 13.5% vs. 11.0% (p=0.40) in the <3%, 3-5%, and ≥5% STS score strata, respectively. Among patients at intermediate surgical risk but with an STS PROM <3%, TAVI may achieve superior clinical outcomes compared to SAVR. These findings support the need for an adequately powered randomised trial to compare TAVI with SAVR in patients at low operative risk.

Incidence, Predictors, and In-Hospital Outcomes of Transcatheter Aortic Valve Implantation After Nonelective Admission in Comparison With Elective Admission: From the Nationwide Inpatient Sample Database

Candidates for transcatheter aortic valve implantation (TAVI) are generally older with multiple co-morbidities and are therefore susceptible to nonelective admissions before scheduled TAVI. Frequency, predictors, and outcomes of TAVI after nonelective admission are under-explored. We queried the Nationwide Inpatient Sample database, an administrative database, from January 2012 to September 2015 to identify hospitalization in those age ≥50 who had transarterial TAVI. A propensity-matched cohort was created to compare the outcomes between nonelective and elective admission who had TAVI. The primary outcome was in-hospital mortality. A total of 9,521 TAVI admissions were identified during the study period. Of these admissions, 22.3% were nonelective admissions. Pulmonary circulation disorders (adjusted odds ratio [aOR] 1.38), anemia (aOR 1.54), congestive heart failure (aOR 1.37), chronic kidney disease (aOR 1.28; all p <0.001), and atrial fibrillation (aOR 1.17, p = 0.006) were independent risk factors for nonelective admission. In a propensity-matched cohort (1,683 admissions in each cohort), in-hospital mortality was similar (4.0% vs 2.8%, p = 0.052). Nonelective admissions had higher rates of acute myocardial infarction (5.2% vs 0.7%), fatal arrhythmia (9.4% vs 6.0%), acute kidney injury (25.9% vs 17.1%), respiratory failure requiring intubation (0.26% vs 0.19%), cardiogenic shock (5.1% vs 2.1%; all p <0.001), and bleeding requiring transfusion (13.1% vs 10.1%, p = 0.006) during the index-hospitalization. Hospital length of stay (11.4 days vs 6.5 days, p <0.001) and hospital cost ($68,669 vs $57,442, p <0.001) were both increased in nonelective admissions. Nonelective admission accounted for approximately one-fifth of total TAVI with significantly different cohort profiles. Our results suggest that nonelective TAVI has higher adverse outcomes and increased health resource utilization. Expedition in TAVI process in high-risk cohorts may result in better outcomes.

Comparison of Outcomes of Transfemoral Versus Transapical Approach for Transcatheter Aortic Valve Implantation

Post hoc analyses of clinical trials have shown superior outcomes for a transfemoral (TF) compared with a transapical (TA) approach for transcatheter aortic valve implantation (TAVI). There are few contemporary data on utilization and outcomes of TF versus TA TAVI in real-world patient populations. Using the National Inpatient Sample 2011 to 2014, we identified TF-TAVI and TA-TAVI procedures using ICD-9 procedure codes 35.05 and 35.06, respectively. A propensity-matched cohort of TF and TA TAVI procedures balanced on 23 baseline characteristics was assembled. Outcomes included in-hospital mortality, acute kidney injury (AKI), AKI requiring dialysis (AKI-D) and postoperative stroke. A total of 7,973 TAVI procedures representative of 39,745 procedures nationally were included in the study. Of these, 80.2% were performed using a TF approach while 19.8% used a TA approach. Patients in the TF-TAVI group were older (mean age 81.7 vs 80.4 years, p < 0.001), with a higher prevalence of heart failure (12.7% vs 7.6%, p < 0.001) and lower prevalence of peripheral vascular disease (28.0% vs 35.5%, p < 0.001) compared with the TA-TAVI group. In 1,576 propensity-matched pairs of TF-TAVI and TA-TAVI procedures, TF-TAVI was associated with significantly lower in-hospital mortality (odds ratio [OR] 0.61, 95% confidence interval [CI] 0.42 to 0.88, p = 0.01), lower rates of AKI (0.53, 95% CI 0.44 to 0.63, p < 0.001), similar rates of AKI-D (OR 0.77, 95% CI 0.44 to 1.38, p = 0.38) and postoperative stroke (OR 1.19, 95% CI 0.67 to 2.10, p = 0.56) compared with TA-TAVI. In conclusion, TF-TAVI is associated with lower rates of in-hospital mortality and AKI compared with TA-TAVI. A TF approach should be preferred over a TA approach for TAVI whenever possible.

Comparison of Hospital Outcomes of Transcatheter AorticValve Implantation With Versus Without Hypothyroidism

Comparative outcomes of transcatheter aortic valve implantation (TAVI) in patients with and without hypothyroidism were not previously reported. This study aimed to appraise the clinical outcomes and impact of hypothyroidism on patients who underwent TAVI. Patients with hypothyroidism who underwent TAVI from 2011 to 2014 were identified in the National Inpatient Sample database using the International Classification of Diseases, ninth Revision, Clinical Modification. The primary outcome was the effect of hypothyroidism on inpatient mortality. Secondary outcomes were the impact of hypothyroidism on post-TAVI complications. We also evaluated the length of hospital stay and the cost of hospitalization. Propensity score-matched analysis was performed to address potential confounding. The hypothyroid patients who underwent TAVI had no significant increase in the risk of in-hospital mortality (odds ratio 0.78; 95% confidence interval 0.51 to 1.21, p = 0.282), or most postprocedural complications. However, hypothyroid patients were more likely to develop hemorrhage requiring transfusion (odds ratio 1.36, 95% confidence interval 1.05 to 1.76, p = 0.043). In conclusion, TAVI is a feasible and relatively safe alternative with reasonable in-hospital outcomes in patients with hypothyroidism and severe symptomatic aortic stenosis. However, hypothyroid patients are more likely to require a blood transfusion after TAVI. Additional randomized trials are needed to evaluate TAVR outcomes in hypothyroid patients.

Do frailty measures improve prediction of mortality and morbidity following transcatheter aortic valve implantation? An analysis of the UK TAVI registry

ObjectivesPrevious studies indicate frailty to be associated with poor outcomes following transcatheter aortic valve implantation (TAVI), but there is limited evidence from multicentre registries. The aim was to investigate the...

Meta-analysis of the Impact of Avoiding Balloon Predilation in Transcatheter Aortic Valve Implantation

Balloon predilation (BPD) has been an integral part of transcatheter aortic valve implantation (TAVI) since inception. We sought to investigate the effect of avoiding BPD on outcomes of TAVI across different valve types. Articles were included if outcomes of TAVI without BPD were reported. Pooled meta-analysis used a random effects model and reported odds ratios (ORs). Twenty-one studies with 10,752 patients were pooled for analysis. Age and gender were well matched between NoBPD and BPD groups. There was no difference in mortality, stroke, bleeding, and acute kidney injury. NoBPD showed lower pacemaker rates (OR 0.84, 95% confidence interval [CI] 0.72 to 0.97), vascular complications (OR 0.77, 95% CI 0.62 to 0.95), and early safety at 30 days (OR 0.81, 95% CI 0.66 to 0.99). For balloon-expandable valves, lower rates of aortic regurgitation (OR 0.73, 95% CI 0.53 to 0.99) and early safety (OR 0.68, 95% CI 0.55 to 0.85) were seen. Self-expanding valves showed lower pacemaker (OR 0.80, 95% CI 0.66 to 0.97) and vascular complications (OR 0.70, 95% CI 0.50 to 0.99), with a trend toward higher postdilation (OR 1.51, 95% CI 0.85 to 2.67). TAVI without BPD is safe and effective. NoBPD is associated with fewer vascular complications, less aortic regurgitation, and fewer pacemaker requirements and composite early safety end points.

Updated clinical indications for transcatheter aortic valve implantation in patients with severe aortic stenosis: expert opinion of the Italian Society of Cardiology and GISE.

: The introduction of percutaneous treatment of severe aortic stenosis with transcatheter aortic valve implantation (TAVI) remains one of the greatest achievements of interventional cardiology. In fact, TAVI emerged as a better option than either medical therapy or balloon aortic valvuloplasty for patients who cannot undergo surgical aortic valve replacement (SAVR) or are at high surgical risk. Recently, increased operator experience and improved device systems have led to a worldwide trend toward the extension of TAVI to low-risk or intermediate-risk patients. In this expert opinion paper, we first discuss the basic pathophysiology of aortic stenosis in different settings then the key results of recent clinical investigations on TAVI in intermediate-risk aortic stenosis patients are summarized. Particular emphasis is placed on the results of the nordic aortic valve intervention, placement of aortic transcatheter valves (PARTNER) 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Randomized trials. The PARTNER 2 was the first large randomized trial that evaluated the outcome of TAVI in patients at intermediate risk. The PARTNER 2 data demonstrated that TAVI is a feasible and reasonable alternative to surgery in intermediate-risk patients (Society of Thoracic Surgeons 4-8%), especially if they are elderly or frail. There was a significant interaction between TAVI approach and mortality, with transfemoral TAVI showing superiority over SAVR. Moreover, we examine the complementary results of the recently concluded Surgical Replacement and Transcatheter Aortic Valve Implantation trial. This prospective randomized trial demonstrated that TAVI is comparable with surgery (primary end point 12.6% in the TAVI group vs. 14.0% in the SAVR group) in severe aortic stenosis patients deemed to be at intermediate risk. We review the most relevant clinical evidence deriving from nonrandomized studies and meta-analyses. Altogether, clinical outcome available data suggest that TAVI with a newer generation device might be the preferred treatment option in this patient subgroup. Finally, the differences between the latest European and American Guidelines on TAVI were reported and discussed. The conclusion of this expert opinion article is that TAVI, if feasible, is the treatment of choice in patients with prohibitive or high surgical risk and may lead to similar or lower early and midterm mortality rates compared with SAVR in intermediate-risk patients with severe aortic stenosis.

Two-Year Outcomes of Transcatheter Compared With Surgical Aortic Valve Replacement in “Minimal-Risk” Patients Lacking EuroSCORE Co-morbidities (from the TAVIK Registry)

We aimed to compare the outcomes of transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) in an elderly but nonfrail, minimally co-morbid population. Although data comparing these 2 procedures in intermediate- and low-risk patients are mounting, no distinction has been made between co-morbidity and age/gender as driving forces for surgical risk. Patients undergoing isolated TAVI or SAVR between May 2008 and March 2015 were documented. Data for 225 patients (TAVI 132, SAVR 93) aged ≥75 and <86 years and fulfilling minimal-risk criteria were analyzed. Patients who underwent TAVI were older (80.7 vs 77.4 years, p <0.0001) and had a higher mean Society of Thoracic Surgeons score (2.16% vs 1.72%, p <0.0001). Mild prosthetic valve regurgitation (odds ratio [OR] 4.9, 95% confidence interval [CI] 3.34 to 7.20) was more likely after TAVI, as were renal complications (predominantly stage I acute kidney injury; OR 2.86, 95% CI 1.79 to 4.55) and new pacemaker implantation (OR 3.33, 95% CI 1.76 to 6.26) at 30 days; however, life-threatening bleeding (OR 0.58, 95% CI 0.36 to 0.93) and reintervention for bleeding (OR 0.03, 95% CI 0.01 to 0.13) were less likely. Survival was comparable between groups at 30 days (99.2% vs 100%, p = 1.0) and 1 year (96.2% vs 96.8%, OR 0.85, 95% CI 0.20 to 3.63, p = 0.823), but it was poorer for patients who underwent TAVI at 2 years (OR 0.31, 95% CI 0.16 to 0.61). In conclusion, the short-term outcomes of TAVI in elderly, low-risk, minimally co-morbid patients appear to be similar to those of SAVR, with access-specific complications. Although these results point toward the potential for more liberal use of TAVI in minimal-risk patients, poorer midterm survival remains a concern, requiring further exploration.

Comprehensive geriatric assessment in patients undergoing transcatheter aortic valve implantation \u2013 results from the CGA-TAVI multicentre registry

BackgroundIn older patients with aortic stenosis (AS) undergoing TAVI, the potential role of prior CGA is not well established. To explore the value of comprehensive geriatric assessment (CGA) for predicting mortality and/or hospitalisation within the first 3 months after transcatheter aortic valve implantation (TAVI).MethodsAn international, multi-centre, prospective registry (CGA-TAVI) was established to gather data on CGA results and medium-term outcomes in geriatric patients undergoing TAVI. Logistic regression was used to evaluate the predictive value of a multidimensional prognostic index (MPI); a short physical performance battery (SPPB); and the Silver Code, which was based on administrative data, for predicting death and/or hospitalisation in the first 3 months after TAVI (primary endpoint).ResultsA total of 71 TAVI patients (mean age 85.4 years; mean log EuroSCORE I 22.5%) were enrolled. Device success according to VARC criteria was 100%. After adjustment for selected baseline characteristics, a higher (poorer) MPI score (OR: 3.34; 95% CI: 1.39–8.02; p = 0.0068) and a lower (poorer) SPPB score (OR: 1.15; 95% CI: 1.01–1.54; p = 0.0380) were found to be associated with an increased likelihood of the primary endpoint. The Silver Code did not show any predictive ability in this population.ConclusionsSeveral aspects of the CGA have shown promise for being of use to physicians when predicting TAVI outcomes. While the MPI may be useful in clinical practice, the SPPB may be of particular value, being simple and quick to perform. Validation of these findings in a larger sample is warranted.Trial registrationThe trial was registered in ClinicalTrials.gov on November 7, 2013 (NCT01991444).

Abstract 21309: Transcatheter Aortic Valve Implantation Outcomes in Patients With History of Previous Cardiac Surgery: A National in Patient Sample Analysis

Introduction: The influence of previous cardiac surgery (CABG, Valve Replacement or both) on In-hospital clinical outcomes in patients(pts) undergoing Transcatheter Aortic Valve Implantation (TAVI) has not been well established. Methods: We analyzed the clinical characteristics and periprocedural in-hospital outcomes among pts undergoing TAVI using 2011-2014 HCUP-Nationwide Inpatient Sample database. ICD-9-CM codes were used to identify pts undergoing TAVI with and without history cardiac surgery. Propensity score matching has been attempted to minimize bias. SAS software was used for statistical analysis with p &lt; .05 used to indicate statistical significance. Results: Among a total of 8466 pts who underwent TAVI during the study period, 1982 had a history of previous cardiac surgery. It was noted that pts with prior cardiac surgery were dominantly male and had a higher prevalence of unfavorable clinical characteristics except pulmonary hypertension (Table). The propensity-matched analysis for 3834 patients showed that the incidence of periprocedural of stroke (2.61% vs1.62%,p=0.03) was lower in pts with previous cardiac surgery. Whereas the prevalence of In-hospital mortality(3.29% vs 2.35% p=0.07), vascular complications(9.96% vs 9.08%,p=0.34), transfusion(23% vs 20.45%,p=0.055), Acute Kidney Injury (AKI)(18.41% vs 16.95%, p=0.23), and pacemaker implantation(10.64 vs 9.29, p=0.16) were comparable for the two cohorts. Conclusions: In Pts with a history of previous cardiac surgery undergoing TAVI there is a lower incidence of periprocedural stroke compared to those without a history of cardiac surgery. The rates of in-hospital mortality, vascular complications, transfusion, Acute Kidney Injury (AKI), and pacemaker implantation were similar between both the groups.

Transcatheter aortic valve implantation for mixed versus pure stenotic aortic valve disease.

In addition to patients with pure/predominant aortic stenosis (PAS), real-world transcatheter aortic valve implantation (TAVI) referrals include patients with mixed aortic valve disease (MAVD; severe stenosis+moderate-severe regurgitation). We sought to compare TAVI outcomes in patients with MAVD vs. PAS. Out of 793 consecutive patients undergoing TAVI, 106 (13.4%) had MAVD. Patients with MAVD were younger and had a higher operative risk, a more severe adverse cardiac remodelling, and a worse functional status than patients with PAS. Moderate-severe prosthetic valve regurgitation (PVR) was significantly more frequent in patients with MAVD than in patients with PAS (15.7% vs. 3.6%, p=0.003), even after propensity-score and multivariable adjustments. Moderate-severe PVR was associated with increased one-year mortality in patients with PAS (log-rank p=0.002), but not in patients with MAVD (log-rank p=0.27). Eventually, all-cause and cardiac mortality as well as the functional capacity were similar in the two study groups up to one year. A significant proportion of patients referred for TAVI in a real-world registry has MAVD. Moderate-severe AR at baseline can influence the rate and modify the clinical sequelae of post-TAVI PVR. Eventually, clinical outcomes in patients with MAVD are comparable to those in patients with PAS in the acute and midterm phases, in spite of a baseline higher risk. MAVD should not be considered a contraindication for TAVI.

Effectiveness and Safety of Transcatheter Aortic Valve Implantation for Aortic Stenosis in Patients With “Porcelain” Aorta

Surgical aortic valve replacement (SAVR) in patients with porcelain aorta is considered a high-risk procedure. Hence, transcatheter aortic valve implantation (TAVI) is emerging as the intervention of choice. However, there is a paucity of data directly comparing TAVI with SAVR in patients with porcelain aorta. We compared outcomes of TAVI versus SAVR in high-risk patients with porcelain between March 2012 and June 2015. The TAVI group included 54 patients, whereas 130 SAVR patients with porcelain aorta were identified (operated on between 2004 and 2015). Both groups were matched 1:1 based on the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score with a 0.5% a priori caliper, resulting in 52 matched pairs. The mean STS-PROM was 7.3 ± 3.9 for both groups (p = 0.98), whereas mean age was 77.5 years for TAVI and 78.8 years for SAVR (p = 0.46). Compared with SAVR, TAVI patients had lower operative mortality (3.8% vs 17.3%; p = 0.052), significantly shorter median intensive care unit (40 vs 107 hours; p < 0.001) and hospital (5 vs. 7 days; p < 0.001) length of stay (LOS), but similar postoperative stroke rates (7.7% vs 11.5%; p = 0.74). One-year unadjusted survival was 81.7% (95% confidence interval [CI]: 69.8% to 93.5%) in the TAVI group versus 71.2% (95% CI: 61.0% to 85.1%) in the SAVR group, p = 0.093. Cox proportional hazard modeling identified preoperative chronic kidney disease (hazard ratio: 2.63 [95% CI: 1.03 to 6.70]; p = 0.043) and SAVR (hazard ratio: 2.641 [95% CI: 1.07 to 6.51]; p = 0.035) as significant predictors for decreased survival. Overall, TAVI was associated with reduced operative mortality, increased survival, and shorter intensive care unit and hospital length of stay compared with SAVR in patients with porcelain aorta. This study demonstrates that TAVI is a safe intervention in this high-risk population.

TCT-784 Evolution of TAVI over an seven-year period – a single-centre experience in 2,000 patients (TAVIK Registry)

Use of transcatheter aortic valve implantation (TAVI) to treat severe aortic stenosis (AS) has gained popularity over time, accompanied by an evolution of patient and clinical factors. We aimed to characterise these changes and evaluate their impact on TAVI outcomes. Prospective, single center

Transapical transcatheter aortic valve implantation in patients with a low ejection fraction.

It may be expected that patients with left ventricular dysfunction may be at greater risk of complications after transcatheter aortic valve implantation (TAVI) via transapical (TA) access compared with via transfemoral (TF) access. There is a lack of data comparing the outcomes of TAVI using TA and TF access in patients with a reduced left ventricular ejection fraction (EF). This is a retrospective analysis of data from a high-volume heart centre in Germany. TAVI access route assignment was based on a 'best for TF' approach, where only patients who met a strict set of criteria underwent TF-TAVI, with the remainder receiving TA-TAVI. For this analysis, patients were included if they had a pre-TAVI EF of ≤ 40%. Early mortality and late (1-year) mortality were compared through multivariate logistic regression. A total of 342 patients in the registry had an EF of ≤ 40%, of which 74.9% underwent TA-TAVI and 25.1% underwent TF-TAVI. Higher proportions of the TA group presented with certain comorbidities, and their logistic EuroSCORE and Society of Thoracic Surgeons (STS) risk scores were higher than in the TF group. At 1 year, TA access was associated with greater mortality in the univariate analysis (odd ratio 2.43; 95% confidence interval 1.04-5.69). However, after multivariate adjustment, no significant differences were found in either 30-day or 1-year mortality rates. The data suggest that, for patients with a reduced EF, TA-TAVI is not associated with a poorer outcome compared with TF-TAVI. Therefore, TA access should not be discounted based on the presence of left ventricular dysfunction alone.

Mid-term study of transcatheter aortic valve implantation in an Asian population with severe aortic stenosis: two-year Valve Academic Research Consortium-2 outcomes.

Transcatheter aortic valve implantation (TAVI) is an effective treatment for high-risk or inoperative patients with severe aortic stenosis. Given the unique characteristics of Asian populations, questions regarding mid-term outcomes in Asians undergoing TAVI have yet to be addressed. We evaluated the two-year clinical outcomes of TAVI in an Asian population using Valve Academic Research Consortium-2 definitions. This prospective study recruited 59 patients from a major academic medical centre in Singapore. The main outcomes were two-year survival rates, peri-procedural complications, symptom improvement, valvular function and assessment of learning curve. Mean age was 76.8 years (61.0% male), mean body surface area 1.6 m2 and mean logistic EuroSCORE 18.7%. Survival was 93.2%, 86.0% and 79.1% at 30 days, one year and two years, respectively. At 30 days post TAVI, the rate of stroke was 1.7%, life-threatening bleeding 5.1%, acute kidney injury 25.0%, major vascular complication 5.1%, and new permanent pacemaker implantation 6.8%. 29.3% of TAVI patients were rehospitalised (47.1% cardiovascular-related) within one year. These composite outcomes were measured: device success (93.2%); early safety (79.7%); clinical efficacy (66.1%); and time-related valve safety (84.7%). Univariate analysis found these predictors of two-year all-cause mortality: logistic EuroSCORE (hazard ratio [HR] 1.07; p < 0.001); baseline estimated glomerular filtration rate (HR 0.97; p = 0.048); and acute kidney injury (HR 5.33; p = 0.022). Multivariate analysis identified non-transfemoral TAVI as a predictor of cardiovascular-related two-year mortality (HR 14.64; p = 0.008). Despite the unique clinical differences in Asian populations, this registry demonstrated favourable mid-term clinical and safety outcomes in Asians undergoing TAVI.

Outcomes of Transcatheter Versus Surgical Aortic Valve Implantation for Aortic Stenosis in Patients With Hepatic Cirrhosis

Current risk prediction tools for transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) do not include variables associated with clinically significant hepatic disease. Accordingly, outcome data of TAVI or SAVR in patients with liver cirrhosis are limited. We sought to assess contemporary trends and outcomes of TAVI and SAVR in patients with liver cirrhosis using a national database. The Nationwide Inpatient Sample was used to identify patients with liver cirrhosis who underwent TAVI or SAVR between 2003 and 2014. Outcomes of propensity-matched groups of patients undergoing TAVI or SAVR were assessed. The reported number of TAVI and SAVR procedures in patients with liver cirrhosis increased from 376 cases in 2003 to 1,095 cases in 2014. A total of 1,766 patients with liver cirrhosis who underwent TAVI (n = 174) or SAVR (n = 1,592) were included in the analysis. In-hospital mortality was higher in patients who underwent SAVR versus TAVI (20.2% vs 8%, p <0.001). Major adverse events were also more frequent after SAVR. Propensity matching attained 2 groups of 268 patients who underwent TAVI (n = 134) or SAVR (n = 134). Following propensity matching, in-hospital mortality remained higher in the SAVR group (18.7% vs 8.2%, p = 0.018), but major adverse events were not different between the 2 groups. Hospital length of stay was longer, and nonhome disposition rates were higher in the SAVR group. In conclusion, the number of reported TAVI and SAVR in patients with liver cirrhosis and aortic stenosis increased 3-folds between 2003 and 2014. In these patients, TAVI was associated with lower in-hospital mortality when compared with SAVR.

Systematic review and meta-analysis to compare outcomes between intermediate- and high-risk patients undergoing transcatheter aortic valve implantation.

Recent studies have reported non-inferior outcomes for transcatheter aortic valve implantation (TAVI) compared with surgical aortic valve replacement (SAVR) in intermediate-risk patients. However, a comparison of outcomes among TAVI patients depending upon the surgical risk score has not been performed in a large study. Our aim was to compare the outcomes of TAVI in low-, intermediate-, and high-risk patients, to ascertain if the morbidity and mortality is related to the patient's risk profile or the procedure itself. A thorough computer-based search was performed using Ovid MEDLINE, EMBASE, Google Scholar, and PubMed databases. We included original research studies reporting data on TAVI in the low-, intermediate-, and high-risk groups. Patients in intermediate-risk group were compared to the high-risk cohort for device success, mortality, and complications. A total of 2414 patients in the intermediate-risk group were compared with 1597 high-risk patients. On meta-analysis, intermediate-risk group demonstrated similar device success [odds ratio (OR) 1.29, 95% confidence interval (CI) 0.87-1.90, I2 = 0%, P = 0.2) but a lower 30-day mortality OR 0.54, 95% CI 0.34-0.86, I2 = 49%, P = 0.009). There was no difference in the incidence of stroke (OR 1.17, 95% CI 0.80-1.71, I2 = 36%, P = 0.42) or permanent pacemaker implantation between the two groups (OR 1.04, 95% CI 0.82-1.32, I2 = 41%, P = 0.74). Transcatheter aortic valve implantation in intermediate-risk patients carries a low mortality and high success. Incidence of pacemaker and stroke remains high in the lower risk group.

OBSERVANT II: OBservational Study of Effectiveness of transcatheter aortic valve implantation with new geneRation deVices for severe Aortic steNosis Treatment. Study protocol

The rapid spread of transcatheter aortic valve implantation (TAVI) for the treatment of severe symptomatic aortic stenosis in the last decade in Italy has led to a gradually increasing use of TAVI procedures also in patients potentially eligible for aortic valve replacement (AVR). For this subset of patients, the OBSERVANT study (2011-2012) evaluated the short- and medium term outcome of TAVI vs AVR, at least for the first generations of TAVI devices, but failed to gather information on all the technological innovations occurred in recent years. The launch of a phase II of the study will allow to recruit a new series of TAVI, with different risk profiles compared with the historical OBSERVANT TAVI cohort, in order to assess whether and how much the use of new-generation devices mitigate the differences in outcomes recorded in the OBSERVANT study. OBSERVANT II is an observational multicenter, prospective, cohort study collecting data on patients with severe symptomatic aortic stenosis undergoing TAVI in Italian hospitals since December 15, 2016, for at least 12 months. For each patient, data on demographic characteristics, health status, type of intervention and presence of comorbidities will be collected. Mortality and incidence of in-hospital major adverse cardiac and cerebrovascular events (MACCE) within 36 months of intervention will be the primary adverse outcome. Secondary outcomes will include 30-day mortality and the incidence of MACCE at 12 and 24 months. The statistical hypotheses were formulated considering the results from the OBSERVANT study. Testing these hypotheses will require the recruitment of at least 823 new TAVI. The risk/propensity-adjustment techniques will be used to comparatively evaluate the effectiveness of TAVI vs AVR. Safety and efficacy profiles of the new-generation TAVI prosthesis; comparative effectiveness of the new TAVI prosthesis as compared to TAVI procedures of the OBSERVANT historical cohort; comparative effectiveness of the new TAVI prosthesis as compared to AVR procedures of the OBSERVANT historical cohort. The results of OBSERVANT II will provide information on the effectiveness of TAVI employing new-generation devices and will be a valuable support to give professionals and policy makers evidence-based results useful for decision-making processes.