Transcatheter Aortic Valve Implantation Centres Research Articles

Outcomes and predictors of left ventricle recovery in patients with severe left ventricular dysfunction undergoing transcatheter aortic valve implantation.

Data on the likelihood of left ventricle (LV) recovery in patients with severe LV dysfunction and severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) and its prognostic value are limited. We aimed to assess the likelihood of LV recovery following TAVI, examine its association with midterm mortality, and identify independent predictors of LV function. In our multicentre registry of 17 TAVI centres in Western Europe and Israel, patients were stratified by baseline LV function (ejection fraction [EF] >/≤30%) and LV response: no LV recovery, LV recovery (EF increase ≥10%), and LV normalisation (EF ≥50% post-TAVI). Our analysis included 10,872 patients; baseline EF was ≤30% in 914 (8.4%) patients and >30% in 9,958 (91.6%) patients. The LV recovered in 544 (59.5%) patients, including 244 (26.7%) patients whose LV function normalised completely (EF >50%). Three-year mortality for patients without severe LV dysfunction at baseline was 29.4%. Compared to this, no LV recovery was associated with a significant increase in mortality (adjusted hazard ratio 1.32; p<0.001). Patients with similar LV function post-TAVI had similar rates of 3-year mortality, regardless of their baseline LV function. Three variables were associated with a higher likelihood of LV recovery following TAVI: no previous myocardial infarction (MI), estimated glomerular filtration rate >60 mL/min, and mean aortic valve gradient (mAVG) (expressed either as a continuous variable or as a binary variable using the standard low-flow, low-gradient aortic stenosis [AS] definition). LV recovery following TAVI and the extent of this recovery are major determinants of midterm mortality in patients with severe AS and severe LV dysfunction undergoing TAVI. Patients with no previous MI and those with an mAVG >40 mmHg show the best results following TAVI, which are at least equivalent to those for patients without severe LV dysfunction. (ClinicalTrials.gov: NCT04031274).

Telemedical management in patients waiting for transcatheter aortic valve implantation: the ResKriVer-TAVI study design.

The majority of patients with severe aortic stenosis (AS) planned for transcatheter aortic valve implantation (TAVI) are elective outpatients. During the COVID-19 pandemic, the time between the heart team's decision and TAVI increased due to limited healthcare resources. We therefore implemented telemedical approaches to identify AS patients at risk for clinical deterioration during the waiting time. The purpose of the prospective, randomized, controlled ResKriVer-TAVI study (DRKS00027842) is to investigate whether a digital concept of telemedical interventional management (TIM) in AS patients waiting for TAVI improves the clinical outcomes. In the present article, we report the study protocol of the ResKriVer-TAVI trial. ResKriVer-TAVI will enroll AS patients planned for elective TAVI. Randomization to the TIM group or standard care will be made on the day of the heart team's decision. TIM will include a daily assessment of weight, blood pressure, a 2-channel electrocardiogram, peripheral capillary oxygen saturation, and a self-rated health status until admission for TAVI. TIM will allow optimization of medical therapy or an earlier admission for TAVI if needed. Standard care will not include any additional support for patients with AS. All patients of the TIM group will receive a rule-based TIM including standard operating procedures when a patient is crossing prespecified values of a vital sign. The primary endpoint consists of days lost due to cardiovascular hospitalization and death of any cause within 180 days after the heart team's decision. Major secondary endpoints include all-cause mortality within 365 days, the number of telemedical interventions, and adherence to TIM. Follow-up visits will be conducted at admission for TAVI as well as 6 and 12 months after the heart team's decision. ResKriVer-TAVI will be the first randomized, controlled trial investigating a telemedical approach before TAVI in patients with AS. We hypothesize that primary and secondary endpoints of AS patients with TIM will be superior to standard care. The study will serve to establish TIM in the clinical routine and to increase the resilience of TAVI centers in situations with limited healthcare resources.

Comparison of MANTA versus Perclose Prostyle large-bore vascular closure devices during transcatheter aortic valve implantation.

New vascular closure devices (VCD) are being introduced for achieving hemostasis after transcatheter aortic valve implantation (TAVI). However, no safety or efficacy data have been published compared to other contemporary VCD. To compare the safety and efficacy of suture-based Perclose Prostyle as compared to plug-based MANTA device. A total of 408 consecutive TAVI patients from two high volume TAVI centers were included in the present study. Patients were grouped according to VCD: Prostyle versus MANTA. Propensity score matching (PSM) and multivariable analysis were utilized to compare clinical endpoints between the two groups. The primary endpoint was any vascular complication (VC) according to VARC-3 criteria. After PSM, a total of 264 patients were analyzed, of them 132 in each group. Overall baseline characteristics of the two groups were comparable. Primary end-point was similar between MANTA as compared to Prostyle (16.7% vs. 15.3% respectively, p = 0.888). The main driver for VC among MANTA group were minor vascular complications (15.2%). Conversely, minor and major VC contributed equally to the primary endpoint among Prostyle group (7.6%) (p = 0.013). No outcome predictors were identified in multivariate analysis. VCD for transfemoral TAVI using the new-generation Prostyle device or the MANTA device achieved comparable VARC-3 VC rates.

Valve Hemodynamics by Valve Size and 1-Year Survival Following Implantation of the Portico Valve in the Multicenter CONFIDENCE Registry

BackgroundThe CONtrolled delivery For ImproveD outcomEs with cliNiCal Evidence registry was initiated to characterize the clinical safety and device performance from experienced transcatheter aortic valve implantation (TAVI) centers in Europe and Australia that use the Portico valve to treat patients with severe aortic stenosis. We herein report for the first time the valve performance at 30-day across all implanted valve sizes and the 1-year survival from this registry. MethodsThis was a prospective, multicenter, single-arm observational clinical investigation of patients clinically indicated for implantation of a Portico valve in experienced TAVI centers. Patients were treated with a commercially available valve (size 23, 25, 27, or 29 mm) using either the first-generation delivery system (DS) (n = 501) or the second-generation (FlexNav) DS (n = 500). Adverse events were adjudicated by an independent clinical events committee according to Valve Academic Research Consortium-2 criteria. Echocardiographic outcomes were assessed at 30 days by an independent core laboratory, and a survival check was performed at 1 year. ResultsWe enrolled 1001 patients (82.0 years, 62.5% female, 63.7% New York Heart Association functional class III/IV at baseline) from 27 clinical sites in 8 countries across Europe and one site in Australia. Implantation of a single valve was successful in 97.5% of subjects. Valve hemodynamics at 30 days were substantially improved relative to baseline, with large aortic valve areas and low mean gradients across all implanted valve sizes (aortic valve areas were 1.7 ± 0.4, 1.7 ± 0.5, 1.8 ± 0.5, and 2.0 ± 0.5 cm2, and mean gradients were 7.0 ± 2.7, 7.5 ± 4.7, 7.3 ± 3.3, and 6.4 ± 3.3 mmHg for 23, 25, 27, and 29 mm valve sizes, respectively). Across all implanted valve sizes, most patients (77.1%) had no patient-prosthesis mismatch. Death from any cause within 1 year occurred in 13.7% of the patients in the first-generation DS group as compared with 11.0% in the second-generation DS group (p = 0.2). ConclusionsThe Portico valve demonstrated excellent hemodynamic performance across all valve sizes in a large cohort of subjects implanted in experienced TAVI centers. One-year survival rates were favorable when using both the first-generation and second-generation (FlexNav) DSs in this high-risk cohort. ClinicalTrials.gov IdentifierNCT03752866.

Contemporary European practice in transcatheter aortic valve implantation: results from the 2022 European TAVI Pathway Registry.

A steep rise in the use of transcatheter aortic valve implantation (TAVI) for the management of symptomatic severe aortic stenosis occurred. Minimalist TAVI procedures and streamlined patient pathways within experienced Heart Valve Centres are designed to overcome the challenges of ever-increasing procedural volume. The 2022 European TAVI Pathway Survey aims to describe contemporary TAVI practice across Europe. Between October and December 2022, TAVI operators from 32 European countries were invited to complete an online questionnaire regarding their current practice. Responses were available from 147 TAVI centres in 26 countries. In 2021, the participating centres performed a total number of 27,223 TAVI procedures, with a mean of 185 TAVI cases per centre (median 138; IQR 77-194). Treatment strategies are usually (87%) discussed at a dedicated Heart Team meeting. Transfemoral TAVI is performed with local anaesthesia only (33%), with associated conscious sedation (60%), or under general anaesthesia (7%). Primary vascular access is percutaneous transfemoral (99%) with secondary radial access (52%). After uncomplicated TAVI, patients are transferred to a high-, medium-, or low-care unit in 28%, 52%, and 20% of cases, respectively. Time to discharge is day 1 (12%), day 2 (31%), day 3 (29%), or day 4 or more (28%). Reported adoption of minimalist TAVI techniques is common among European TAVI centres, but rates of next-day discharge remain low. This survey highlights the significant progress made in refining TAVI treatment and pathways in recent years and identifies possible areas for further improvement.

Comparison of transcarotid versus transapical transcatheter aortic valve implantation outcomes in patients with severe aortic stenosis and contraindications for transfemoral access.

The purpose of this study was to compare the safety and clinical outcomes of transcarotid (TC) and transapical access (TA) transcatheter aortic valve implantation (TAVI) patients whom the transfemoral approach (TF) was not feasible. The analysis included consecutive patients with severe symptomatic aortic stenosis treated from 2017 to 2020 with TC-TAVI or TA-TAVI in two high-volume TAVI centers. The approach was selected by multidisciplinary heart teams after analyzing multislice computed tomography of the heart, aorta and peripheral arteries, transthoracic echocardiography and coronary angiography. One hundred and two patients were treated with alternative TAVI accesses (TC; n = 49 and TA; n = 53) in our centers. The groups were similar regarding age, gender, New York Heart Association class, and echocardiography parameters. Patients treated with TC-TAVI had significantly higher surgical risk. The procedural success rate was similar in both groups (TC-TAVI 98%; TA-TAVI 98.1%; p = 0.95). The rate of Valve Academic Research Consortium-2 defined clinical events was low in both groups. The percentage of new-onset rhythm disturbances and permanent pacemaker implantation was similar in TC and TA TAVI (4.1% vs. 11.3%; p = 0.17 and 10.2% vs. 5.7%; p = 0.39, respectively). In the TA-TAVI group, significantly more cases of pneumonia and blood transfusions were observed (11% vs. 0%; p = 0.01 and 30.2% vs. 12.2%; p = 0.03). The 30-day mortality was similar in TC and TA groups (4.1% vs. 5.7%; p = 0.71, respectively). Both TC and TA TAVI are safe procedures in appropriately selected patients and are associated with a low risk of complications.

Machine learning for prediction of all-cause mortality after transcatheter aortic valve implantation.

Prediction of adverse events in mid-term follow-up after transcatheter aortic valve implantation (TAVI) is challenging. We sought to develop and validate a machine learning model for prediction of 1-year all-cause mortality in patients who underwent TAVI and were discharged following the index procedure. The model was developed on data of patients who underwent TAVI at a high-volume centre between January 2013 and March 2019. Machine learning by extreme gradient boosting was trained and tested with repeated 10-fold hold-out testing using 34 pre- and 25 peri-procedural clinical variables. External validation was performed on unseen data from two other independent high-volume TAVI centres. Six hundred four patients (43% men, 81±5 years old, EuroSCORE II 4.8 [3.0-6.3]%) in the derivation and 823 patients (46% men, 82±5 years old, EuroSCORE II 4.7 [2.9-6.0]%) in the validation cohort underwent TAVI and were discharged home following the index procedure. Over the 12 months of follow-up, 68 (11%) and 95 (12%) subjects died in the derivation and validation cohorts, respectively. In external validation, the machine learning model had an area under the receiver-operator curve of 0.82 (0.78-0.87) for prediction of 1-year all-cause mortality following hospital discharge after TAVI, which was superior to pre- and peri-procedural clinical variables including age 0.52 (0.46-0.59) and the EuroSCORE II 0.57 (0.51-0.64), P<0.001 for a difference. Machine learning based on readily available clinical data allows accurate prediction of 1-year all-cause mortality following a successful TAVI.

In-Hospital Outcomes of Surgical Aortic Valve Replacement at Transcatheter Valve Implantation Centers

The availability of transcatheter aortic valve implantation (TAVI) has led to the development of a multidisciplinary team, the "heart team," at institutions offering both TAVI and surgical aortic valve replacement (SAVR). Whether this approach has improved in-hospital outcomes in patients who underwent SAVR at institutions offering TAVI versus those not offering TAVI is largely unknown. The National Inpatient Sample (2011 to 2018) was used to study trends in visits for SAVR and in-hospital outcomes at TAVI and non-TAVI centers. Survey estimation commands were used to determine weighted national estimates. There were 559,365 inpatient visits during 2011 to 2018 for aortic valve replacement, with 65.9 ± 0.8% and 34.0 ± 0.8% at TAVI and non-TAVI centers, respectively. Patients who underwent SAVR at TAVI hospitals had more co-morbidities and were less likely to receive mechanical prosthesis (24.7 ± 0.5% vs 35.5 ± 0.6%). Adjusted in-hospital mortality was lower among any SAVR (odds ratio 0.84, 95% confidence interval 0.75 to 0.94) and isolated SAVR (odds ratio 0.83, 95% confidence interval 0.70 to 0.98) recipients at TAVI centers. There was no difference in the incidence of stroke, permanent pacemaker placement, and acute kidney injury after SAVR in TAVI and non-TAVI centers. Although patients who underwent SAVR at TAVI centers had more co-morbidities, in-hospital mortality was lower at TAVI centers than non-TAVI centers. This may be attributable to several factors, including but not limited to experience, resource availability, and operative volumes and the use of the heart team.

Apical versus subclavian transcatheter aortic valve implantation: An 8-year United Kingdom analysis.

Subclavian (SC) and transapical (TA) approaches are the main alternatives to the default femoral delivery for transcatheter aortic valve implantation (TAVI). The aim of this study was to comparecomplications and morbidity/mortality associated with SC and TA in a long-term time frame. From January 2007 to July 2015, 1506 patients underwent TAVI surgery in 36 United Kingdom TAVI centers. Primary outcomes were complications according to VARC-2 criteria. The secondary outcome was long-term survival. The enrolled patients were distributed as follows: 1216 in the TAgroup and 290 in the SCgroup. There were no differences in the rates of acute myocardial infarction, emergency valve-in-valve, paravalvular leak, balloon post dilatation, cardiac tamponade, stroke, renal replacement therapy, vascular injuries, and 30-daymortality among the groups. Conversely, the rate of permanent pacemaker implantation (p = .02), the procedural time duration (p = .04), and the 12-month mortality (p = .03) was higher in SC than in TA, while in-hospital length of stay was reduced in SC than in TA (p = .01). Up to 8 years, the long-term mortality was not different among groups (p = .77), and no difference in long-term survival between self- versus balloon-expandable devices was found (p = .26). According to our results, TA provided the best 12-monthsurvival compared to SC, while the long-term survival up to 2900 days is not significantly different between groups, so SC and TA may both represent a safe non-femoral access if femoral is precluded.

Machine Learning for Predicting Mortality in Transcatheter Aortic Valve Implantation: An Inter-Center Cross Validation Study.

Current prognostic risk scores for transcatheter aortic valve implantation (TAVI) do not benefit yet from modern machine learning techniques, which can improve risk stratification of one-year mortality of patients before TAVI. Despite the advancement of machine learning in healthcare, data sharing regulations are very strict and typically prevent exchanging patient data, without the involvement of ethical committees. A very robust validation approach, including 1300 and 631 patients per center, was performed to validate a machine learning model of one center at the other external center with their data, in a mutual fashion. This was achieved without any data exchange but solely by exchanging the models and the data processing pipelines. A dedicated exchange protocol was designed to evaluate and quantify the model’s robustness on the data of the external center. Models developed with the larger dataset offered similar or higher prediction accuracy on the external validation. Logistic regression, random forest and CatBoost lead to areas under curve of the ROC of 0.65, 0.67 and 0.65 for the internal validation and of 0.62, 0.66, 0.68 for the external validation, respectively. We propose a scalable exchange protocol which can be further extended on other TAVI centers, but more generally to any other clinical scenario, that could benefit from this validation approach.

Percutaneous mechanical circulatory support from the collaborative multicenter Mechanical Unusual Support in TAVI (MUST) Registry.

To evaluate the use and outcomes of percutaneous mechanical circulatory support (pMCS) utilized during transcatheter aortic valve implantation (TAVI) from high-volume centers. Our international multicenter registry including 13 high-volume TAVI centers with 87 patients (76.5± 11.8 years, 63.2% men) who underwent TAVI for severe aortic stenosis and required pMCS (75.9% VA-ECMO, 19.5% Impella CP, 4.6% TandemHeart) during the procedure (prior to TAVI 39.1%, emergent rescue 50.6%, following TAVI 10.3%). The procedures were considered high-risk, with 50.6% having severe left ventricular dysfunction, 24.1% biventricular dysfunction, and 32.2% severe pulmonary hypertension. In-hospital and 1-year mortality were 27.5% and 49.4%, respectively. Patients with prophylactic hemodynamic support had lower periprocedural mortality compared to patients with rescue insertion of pMCS (log rank=0.013) and patients who did not undergo cardiopulmonary resuscitation during the TAVI procedure had better short and long term survival (log rank <0.001 and 0.015, respectively). Given the overall survival rate and low frequency of pMCS-related complications, our study results support the use of pMCS prophylactically or during the course of TAVI (bailout) in order to improve clinical outcomes in high-risk procedures or in case of acute life-threatening hemodynamic collapse.

The Polish Interventional Cardiology TAVI Survey (PICTS): 10 years of transcatheter aortic valve implantation in Poland. The landscape after the first stage of the Valve for Life Initiative.

Few studies assessed thedevelopment of transcatheter aortic valve implantation (TAVI) in Poland since its introduction in2008. Effects of theValve for Life Initiative in thecountry have not been reported. Theaim of thestudy was to investigate TAVI adoption and practice in Poland in theyears 2008 to2019. ThePolish Interventional Cardiology TAVI Survey (PICTS) analyzed reports of TAVI activity in all 23 TAVI centers. It consisted of 94 questions and encompassed thefollowing topics: 1) characteristics of centers; 2) theannual number of TAVI procedures in theyears 2008 to 2019; 3) pre-, intra-, and postprocedural management of patients; and 4) alist of TAVI team members. It was obligatory to answer all questions. Theregistry survey was published online. Since 2008, 102 certified operators have performed atotal of 6910 procedures. In 2019, theannual number of TAVI reached 1550 (40.38 implants per 1000000 inhabitants). Among patients aged65 years and older, TAVI penetration rate was 18.65% in2019. Inoperable and high-risk patients were treated in all centers, while 18 also treated medium- and 5 treated low-risk individuals. Therate of transfemoral implantations increased to 93.5% of all procedures. Thesurvey highlighted aslow increase in therate of TAVI adoption in Poland. We found asignificant treatment gap in patients with severe aortic stenosis. Remarkable regional variations in TAVI experience exist among Polish TAVI centers. Further multinational cooperation is warranted to tackle theidentified limitations in access to this life-saving procedure.

Outcomes of the First 300 Cases of Transcatheter Aortic Valve Implantation at a High-Volume Australian Private Hospital

Transcatheter aortic valve implantation (TAVI) was first performed in Australia in 2008 with a steady increase in the number of implanting centres from seven in 2008 to 42 in 2018 (24 private and 18 public hospitals). There is limited published data on outcomes from Australian centres and no published data from Australian private hospitals. We describe outcomes of the first 300 cases at Queensland's first TAVI implanting private hospital. From July 2015 to August 2018, 300 patients with severe, symptomatic aortic stenosis underwent TAVI at our centre. A heart team assessed all patients as suitable. All patients underwent computed tomography (CT) assessment of valve sizing and peripheral access. Median age was 85 years, 58% male, mean Society of Thoracic Surgeons' score 4.0%, 49% had New York Heart Association Class III/IV, 28% previous coronary artery bypass grafts, 14% peripheral vascular disease and 3.7% renal impairment (creatinine >177 μmol/L). At 30 days mortality was 1%, stroke 1.3%, myocardial infarction (MI) 0.3%, major vascular complication 3.0%, no life-threatening or disabling bleeding and new permanent pacemaker (PPM) requirement was 9.0%. Paravalvular leak was none, trace and mild in 27%, 53% and 20% respectively with 0.3%≥moderate paravalvular leak. At 1 year, mortality was 4.2%, stroke 2.1%, MI 0.3%, no life-threatening bleeding and PPM 11.4%. Lower rates of mortality, stroke, and major vascular complications were observed compared to the well-established TAVI centres in USA and Germany. Excellent TAVI clinical outcomes can be achieved in the Australian private hospital setting. Expert heart team assessment and CT guided procedural planning are key to these outcomes.

Impact of Coronary Artery Severity and Revascularization Prior to Transcatheter Aortic Valve Implantation

The prevalence of coexisting coronary artery disease (CAD) is high in patients who underwent transcatheter aortic valve implantation (TAVI). Our objective was to first determine if the severity of CAD before TAVI had an important impact on post-TAVI outcomes and second, if revascularization with percutaneous coronary intervention (PCI) before TAVI modified this relation. In this retrospective population-based study in Ontario, Canada, we identified all patients with obstructive CAD who underwent TAVI from April 1, 2012 to March 31, 2017. Our primary outcomes of interest were all-cause mortality within 30-day and 1-year post-TAVI procedure. Secondary outcomes included 30-day and 1-year all-cause readmissions. We developed multivariable Cox proportional hazard models, with a robust sandwich-type variance estimator to account for clustering within TAVI centers. These models included an interaction term between severity of CAD and PCI before TAVI. The study cohort included 888 of whom 444 (50%) patients underwent PCI before TAVI procedure. In the Cox models, we found that severity of CAD before TAVI was not significantly associated with post-TAVI outcomes. The only exception was 1 to 2 vessel/s disease which was a significant predictor of 1-year readmission. Pre-TAVI PCI was not significantly associated with outcomes, nor did it modify the relation between severity of CAD pre-TAVI and outcomes. In conclusion, we did not find a consistent relation between severity of CAD and revascularization with post-TAVI outcomes.

3326Infective endocarditis after transcatheter aortic valve implantation: findings from a UK nationwide linkage study

Abstract Introduction Infective endocarditis (IE) is a potentially fatal complication of prosthetic valve replacement and increasing use of transcatheter aortic valve implantation (TAVI) has resulted in a new elderly and frail population at increased risk of IE. The incidence of IE after TAVI and factors that influence the risk and subsequent outcome are relatively unknown. Purpose To describe the incidence, predictors, echocardiographic findings, microbiology and clinical outcomes of IE following TAVI in the United Kingdom (UK). Methods Patients who underwent TAVI between Jan 1 2007 and Dec 31 2016 were identified from the UK TAVI database held by the National Institute for Cardiovascular Outcomes Research. For this cohort, all hospital admissions with a primary diagnosis of IE were identified by linkage with the NHS Hospital Episode Statistics Admitted Patient Care database, or by contact with regional TAVI centres. Additional information concerning clinical presentation, imaging findings, microbiology, management and patient outcome were obtained where possible from the treating physician. Results A total of 16,014 patients underwent TAVI, of whom 157 developed IE over a median follow-up of 23.8 (IQR 7.8–52.4) months - an overall incidence of 0.98% (0.53% at one year post-TAVI). The mean age of patients with IE was 79.2±7.8 years, and 69% were male. The median time to IE following TAVI was 10.0 (IQR 4.0–22.3) months. On multivariate analysis, IE was significantly more common in men (HR 2.05, 95% CI 1.35–3.11, p=0.001) and in patients receiving mechanically-expandable (HR 2.15, 95% CI 1.16–4.01, p=0.015) or balloon-expandable valves (HR 1.60, 95% CI 1.01–2.52, p=0.045) compared to self-expanding valves. IE was also more common in those with an aortic valve peak gradient following TAVI deployment greater than median (HR 1.81, 95% CI 1.23–2.67, p=0.003). The most common presenting symptom was fever (present in 67.1%). The most frequent causal organisms were enterococci (25.9%), followed by oral streptococci (16.4%) and Staphylococcus aureus (11.8%). Transoesophageal echocardiography demonstrated vegetations in 72.5% of patients, most commonly on the TAVI valve leaflets (58.8%). Only 8.24% of patients underwent surgical valve intervention. Survival rates at hospital discharge and one year follow up were 61.4% and 54.4%, respectively. Specific factors associated with one-year mortality were cardiogenic shock (HR 4.6, 95% CI 2.1–10.3, p=0.0002), septic shock (HR 3.4, 95% CI 1.4–8.3, p=0.006) and stroke (HR 4.9, 95% CI 1.46–16.7, p=0.01). Conclusions The incidence of IE one year after TAVI was 0.53% and greater risk was associated with male sex, mechanically-expandable and balloon-expandable valves, and elevated post-deployment valve gradient. Enterococci were the most common causative organism. Overall survival at one year was 54.4%, with adverse outcome predicted by cardiogenic shock, septic shock or stroke.

Safety and feasibility of balloon aortic valvuloplasty in non-TAVI centers: The "BAV for life" experience.

To evaluate the safety and the feasibility of balloon aortic valvuloplasty (BAV) procedure made by trained operators in centers not performing transcatheter aortic valve implantation (TAVI). BAV is a valuable therapeutic tool for patients with symptomatic severe aortic valve stenosis (AS) at prohibitive risk for TAVI or surgery. Consecutive high-risk AS patients underwent BAV in five non-TAVI centers, where BAV operators had completed a 6-month training period in high-volume TAVI centers (Group A). All clinical, echocardiographic, and procedural data were prospectively collected and compared with data of patients treated in TAVI center (Group B). Between June 2016 and June 2017, 55 patients (83.9 ± 7.0 years) were enrolled: 25 in Group A and 30 in Group B. After BAV, a substantial reduction of the peak-to-peak aortic valve gradient was obtained in both groups (-35.3 ± 15.2 vs -28.8 ± 13.9 mmHg, P =0.25). No major bleeding or vascular complications occurred. In-hospital death was observed in three patients of Group A and two patients of Group B (P =0.493). The mean follow-up time was 303 ± 188 days; no patients were lost. The 1-year survival free from overall death (Group A 75.8% vs Group B 68.8%; P =0.682) and heart failure rehospitalization (Group A 73.0% vs Group B 66.8%; P =0.687) was similar in the two groups. At multivariable analysis, low left ventricular (LV) ejection fraction (HR: 0.943; P = 0.011) and cardiogenic shock (HR: 5.128; P = 0.002) at admission were independent predictors of mortality. BAV is a safe and effective procedure that can be performed by trained operators in centers not performing TAVI.

PP17 Comprehensive Evaluation Of A Technology With Expanding Indications

Introduction:The use of transcatheter aortic valve implantation (TAVI) is evolving. Our Cardiovascular Evaluation Unit is implementing a comprehensive approach to inform decision-makers on optimal use of TAVI, including the development of quality standards. We are implementing a multifaceted evaluation framework in collaboration with clinical stakeholders.Methods:Our unit has carried out a continuous field evaluation in collaboration with the clinical teams at all six TAVI centers in Québec for the past four years (1 April 2013–31 March 2017), with regular feedback to the teams and sharing of results with each individual center. Hospital documentation was reviewed according to established national quality indicator definitions. Field evaluation data were combined with the results of systematic literature review to establish provincial standards for practice, through a deliberation process by an interdisciplinary committee of clinical experts from each center. Systematic surveillance of the literature is ongoing.Results:In the period 2013–2017, use of TAVI in Québec was limited to very elderly patients with significant comorbidities at high risk of operative mortality. We observed improvements in both processes of care (e.g. documentation of risk scores) and clinical outcomes (e.g. 30-day and 1-year mortality) over time. Our consensus standards recognize the potential value of TAVI for patients at moderate operative risk, identify uncertainties and recommend best practices for patient evaluation and clinical decision-making about choice of treatment.Conclusions:A comprehensive, long-term evaluation process of TAVI with feedback to centers is associated with improvements in processes of care and outcomes. In the present context of expanding clinical indications, we will continue to evaluate patient selection, processes and outcomes according to the newly-established provincial quality standards. This iterative approach facilitates continued evidence generation and decision-making for optimal use of an evolving intervention. We acknowledge the contribution of the members of the expert clinical committee.

ACCELERATED TRANSFER TO THE CARDIOLOGY WARD AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION IN THE CARDIAC CATH LAB: NURSE-LED INITIATIVE TO MATCH CARE TO CONTEMPORARY PRACTICE

Advances in technology and procedural approaches are contributing to the adoption of increasingly minimalist strategies for patients undergoing transcatheter aortic valve implantation (TAVI). The use of local anaesthesia, the avoidance of invasive monitoring lines, and the availability of lower profile devices, augmented by the raised awareness of the risks of rapid deconditioning of the frail elderly, creates opportunities for cardiovascular nurses to revisit historical post-procedure care. The purpose of this presentation is to report on a nurse-led initiative to operationalize the accelerated transfer to the cardiology ward of patients following transfemoral TAVI in the cardiac cath lab. We will discuss the rationale, planning and implementation of the project; we will highlight how we capitalized on the expertise of critical care nurses to provide mentorship to cardiology ward nurses while strengthening transition of care and patient safety. We will present the post-procedure nursing protocol informed by the unique needs of elderly TAVI patients. Lastly, we will report on the findings of the evaluation of the first year of implementation, the lessons learned, and recommendations for TAVI centres to match nursing expertise to the rapidly evolving needs of patients. Cardiovascular nurses have a unique opportunity to lead the transformation of the way we care for TAVI patients to reflect contemporary practice, and maximize nurses’ scope of practice and expertise.

SICI-GISE commuNity CAmpania survey doNna TAVI (INCANTA): perioperative and short-term outcome of transcatheter aortic valve implantation in women

Nowadays the prognostic role of gender as a relevant factor after transcatheter aortic valve implantation (TAVI) is still unfair, since available data in the literature are few and uneven. The aim of this survey was to collect acute and 30-day safety and efficacy clinical data in high- and intermediate-risk women, who underwent TAVI with new-generation devices, in the Campania Region. All medium and high-volume TAVI centers in Campania have been invited to fulfill an online, ad-hoc questionnaire, collecting pre-, peri- and post-procedural data concerning female patients, treated between January and December 2016. 331 women (representing the 61% of the overall population treated; mean age 83 ± 7 years) underwent TAVI in the participating Campania centers. Age >80 years (72%), high surgical risk score (63%) and frailty (55%) were found to be the top three reasons for the TAVI choice. Overall, 95% of the procedures were performed by transfemoral approach with local anesthesia; the remaining 5% (16 cases) were conducted via transapical (14, 4%) and transaortic (2, 1%) accesses, under general anesthesia. Edwards Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and Medtronic Evolut R (Medtronic Inc., Minneapolis, MN, USA) were the most frequently implanted valves (146, 44% and 132, 43%, respectively). The questioned Centers reported a mean length of hospital stay of 5.5 ± 1.1 days, 1.6 ± 0.37 of which in a cardiac care unit. The most prevalent in-hospital complication was pacemaker implantation (15%), followed by life-threatening vascular complications (3%). The 30-day VARC-2 composite endpoint occurred in 7% of cases, all-cause death in 4%, and stroke in 1%. This survey, the first representative of women undergoing TAVI in Campania, appears to confirm the good safety and efficacy profile of this procedure, also in the high- and intermediate-risk settings, probably favored by a prevalent use of new-generation devices and a low rate prevalence of significant patient comorbidities.

Management of Nonagenarian Patients With Severe Aortic Stenosis: The Role of Comorbidity

The number of nonagenarian patients with aortic stenosis will likely increase due to the ageing population. We assessed the clinical characteristics, management, and outcomes of nonagenarian patients with severe aortic stenosis. A total of 177 (117 females and 60 males) consecutive nonagenarian patients from two large contemporary registries were included in this study. Clinical characteristics, comorbidity as assessed by the Charlson Index, clinical management, and outcomes were recorded. The main outcome measure was 1-year mortality. The mean patient age was 91.1 years, and 56 patients (31.6%) had a Charlson Index <3. A strong association between comorbidity and 1-year overall mortality was observed, with higher 1-year mortality in patients with Charlson Index ≥3 (66.4% vs. 32.1%, p<0.001). A total of 150 patients (84.7%) were managed conservatively, and 27 (15.3%) underwent transcatheter aortic valve implantation (TAVI). Predictors of a conservative management were treatment out of TAVI centres, lower mean aortic gradient and better functional class. Clinical management was not significantly different with different degrees of comorbidity. A trend toward higher mortality in patients undergoing conservative management was observed (58% vs. 40.7%, p=0.097). Independent predictors of mortality were higher Charlson Index, lower creatinine clearance, lower mean aortic gradient, poorer left ventricular ejection fraction, significant mitral regurgitation and conservative management. About one third of nonagenarians with severe aortic stenosis have few comorbidities. The clinical management was similar irrespective of the Charlson Index. Both higher Charlson Index values and a conservative management were independently associated with a higher mortality.