Introduction Of Transcatheter Aortic Valve Implantation Research Articles

Contemporary Outcomes of Surgical Aortic Valve Replacement in Japan.

Given the rapid expansion in the use of transcatheter aortic valve implantation (TAVI), recent outcomes of surgical aortic valve replacement (SAVR) should be re-evaluated.Methods and Results:Using the data from the Japan Cardiovascular Surgery Database of 160 enrolled hospitals, trends in elective isolated SAVR were evaluated until the introduction of TAVI in Japan. Trend analyses were performed over 4 periods: period 1, 2008-2009 (4,415 cases); period 2, 2010-2011 (4,861 cases); period 3, 2012-2013 (5,674 cases); and period 4, 2014-2015 (5,563 cases). Baseline risk, evaluated on JapanSCORE, increased significantly over the 4 periods, from a median of 1.56 (IQR, 0.99-2.61) in period 1 to 2.08 (IQR, 1.33-3.96) in period 4 (P<0.001, trend test). Despite the increased risk, the composite major complication and operative mortality rate decreased significantly (10.7% in period 1 to 9.2% in period 4, P=0.01). Using a risk-adjusted model, the OR of operative mortality was 1.61 (95% CI: 1.29-2.02) in period 1 (P<0.0001) compared with period 4. An increase in the use of bioprostheses was also observed, from 60.4% to 76.8% (P<0.001) over the 4 periods. Even in a short 8-year period, SAVR outcomes improved in Japan. This should be taken into account when discussing the indications for aortic valve intervention.

IMPACT OF TRANSCATHETER AORTIC VALVE IMPLANTATION ON THE BURDEN OF AORTIC STENOSIS IN THE PROVINCE OF QUÉBEC, CANADA

Transcatheter aortic valve implantation (TAVI) has been shown to have comparable or better outcomes in aortic stenosis (AS) patients compared to surgical aortic valve replacement (SAVR). The objective of this study was to evaluate the burden and mortality of AS in the province of Québec before (2005) and after the introduction of TAVI (2015). People aged ≥20 years were identified from the Québec Integrated Chronic Disease Surveillance System. Specific International Classification of Diseases (ICD) codes versions 9 and 10, in any position in the hospital files were used to identify AS. To be classified as "operated” AS, specific interventions codes had to be paired with these ICDs codes. Moving averages were used among incident patients. The 2011 Québec standard population was used for age standardization and 95% confidence intervals (CI) were computed. In 2015, the crude prevalence and mortality rate of AS were 0.8% (n=51,785) and 11.7% (n=6,035), respectively. Age-standardized prevalence increased by +7.5%, between 2005 (0.67% [95% CI: 0.66-0.68]) and 2015 (0.72% [0.71-0.73]) while the age-standardized mortality rate decreased by -8.9%, (from 3.5% [3.0-4.5]) to 3.2% [2.8-4.6]). Among incident AS cases in 2014-2016, 3,155 and 195 underwent SAVR and TAVI during initial hospitalization, respectively. Mean ages were 75.13 (SE=0.09) years in 2004-2006 and increased to 77.83 (SE=0.07) in 2014-2016 (p < 0.0001) among incident patients. During this time, the average number of comorbidities per incident patient from the combined Charlson-Elixhauser index increased from 4.71 (SE=0.02) to 5.48 (SE=0.02) and the average score rose from 3.99 (SE=0.03) to 4.60 (SE=0.02). In non-operated patients, age-standardized 30-day mortality rates were 7.0% [6.6-7.4] in 2004-2006 and 7.4% [7.0-7.8] in 2014-2016 (figure 1A), increasing to a 1-year rate of 22.6% [22.0-23.5] in 2004-2006 and 21.5-% [21.0-22.2] in 2014-2016 (figure 1B). The age-standardized 30-day post-SAVR and 1-year mortality rates decreased from 8.6% [7.1-10.6] in 2004-2006 to 4.4% [3.6-5.5] in 2014-2016 and from 13.2% [11.4-15.7] to 8.4% [7.2-9.8], respectively. The age-standardized 30-day and 1-year post-TAVI mortality rate were 2.5% [1.1-5.5] and 7.5% [4.3-13.3], respectively in 2014-2016. Between 2005 and 2015, the AS burden in the province of Québec has increased. Incident patients in 2014-2016 are older, tend to have more comorbidities and survival rates have increased or remained stable. As the major change in AS care in the last decade, the introduction of TAVI could explain this development as the oldest, most fragile or inoperable AS patients now have a safer alternative to SAVR.

A proctoring system to manage the learning curve associated with the introduction of transcatheter aortic valve implantation in Japan.

As transcatheter aortic valve implantation (TAVI) requires multidisciplinary collaboration, operators and the entire heart team must overcome a steep learning curve. A web-based screening and traditional on-site proctoring system were developed for the introduction of TAVI in Japan. To assess the learning curve involved with the introduction of TAVI under the supervision of a novel proctoring system. We divided 749 consecutive patients enrolled in the OCEAN-TAVI study between October 2013 and August 2015 into the trans-femoral (TF, n=608) and transapical (TA, n=141) approach groups to compare outcomes in patients who underwent TAVI during the early proctoring period (proctoring group) and after the procedures began to be performed independently (independent group). The primary endpoint was the rate of composite events regarding early safety (at 30days) according to the valve academic research consortium-2 criteria. For TF-TAVI, the logistic EuroSCORE and the rate of peripheral artery disease were significantly lower during the independent period. The rate of device success significantly increased during the independent period (90.5 vs. 81.8%, p=0.005). The rate of the primary endpoint was significantly reduced during the independent period compared to that during the proctoring period for TA-TAVI (21.3 vs. 37.9%, p=0.031); however, no difference was observed for TF-TAVI (16.8 vs. 13.1%, p=0.283). No deaths occurred within 30days during the proctoring period for TF-TAVI. After adjustment using propensity score matching, the procedure time for TF-TAVI (88±43 vs. 102±36min, p=0.004) and the rate of life-threatening bleeding for TA-TAVI (3.6 vs. 25%, p=0.026) reduced during the independent period compared to the values during the proctoring period. During the introduction of TAVI under the supervision of a new proctoring system in Japan, clinical outcomes and technical aspects improved significantly. There are differences in the steepness of the learning curve between TF-TAVI and TA-TAVI.

Surgical aortic valve replacement outcomes in the transcatheter era

BackgroundThe primary objective of this study was to evaluate the influence of transcatheter aortic valve implantation (TAVI) on the characteristics and outcomes of patients undergoing surgical aortic valve replacement (SAVR) in a single high-volume Canadian center. MethodsBetween January 2003 and December 2013, 1593 patients underwent isolated SAVR at our institution. The study period was divided into 2 distinct cohorts of patients undergoing SAVR: before (n = 529) and after (n = 1064) the first TAVI procedure in May 2007. We compared the risk profiles and clinical outcomes of the 2 cohorts and assessed the multivariate predictors of in-hospital mortality. ResultsThe ratio of isolated SAVR to the total number of cardiac surgery cases per year rose significantly after the introduction of TAVI (7.2% vs 9.1%; P < .0001). There was significantly more diabetes, obesity, recent myocardial infarction, and use of a bioprosthesis among SAVR patients in the post-TAVI era (all P values < .05). In-hospital mortality decreased significantly among SAVR patients following the introduction of TAVI (3.6% vs 1.8%; P = .03). Independent risk factors for in-hospital mortality among the entire study population were SAVR in the pre-TAVI era, baseline creatinine, age, and prosthesis size ≤ 21 mm for the pre-TAVI group only. ConclusionsThe number of isolated SAVR cases increased following the introduction of TAVI. There was a significant reduction in operative mortality of SAVR in the post-TAVI era despite greater severity of several markers of risk. Patient referrals for TAVI should take into consideration the changing risk profiles and improved results of conventional surgery.

Activity and outcomes for aortic valve implantations performed in England and Wales since the introduction of transcatheter aortic valve implantation.

The first transcatheter aortic valve implantation (TAVI) in England and Wales was performed in 2007. This study presents the subsequent national activity and outcomes for both TAVI and aortic valve replacement (AVR). Data for all AVR and TAVI procedures between January 2006 and December 2012 in England and Wales were included. The number of procedures, patient characteristics, in-hospital and 30-day mortality, postoperative length of stay (PLOS) and survival were analysed separately for: isolated AVR; AVR + coronary artery bypass graft (CABG) surgery; AVR + other surgery and TAVI. The number of TAVIs increased from 66 in 2007 (0.8% of all implants) to 1186 in 2012 (10.9% of all implants). AVR activity also increased over the study period. TAVI patients were older and had a higher mean logistic EuroSCORE than all AVR groups. The 30-day mortality rates were 2.1% for isolated AVR, 3.9% for AVR + CABG, 7.7% for AVR + other surgery and 6.2% for TAVI. In-hospital mortality has significantly improved for all groups. The 5-year survival rates were 82.6% for isolated AVR, 81.7% for AVR + CABG, 74.5% for AVR + other surgery and 46.1% for TAVI. The median PLOS after TAVI was similar to that of isolated AVR but shorter than that of the other AVR groups. Since the introduction of TAVI, there has been an increase in both TAVI and AVR activity. TAVIs now represent over 10% of all aortic valve implants. There are distinct differences between procedural groups with respect to patient risk factors. Outcomes for all procedural groups have improved, but long-term TAVI results are required before its role in the treatment of aortic stenosis can be fully defined.

The changing characteristics and outcomes of patients undergoing surgical aortic valve replacement in the transcatheter aortic valve implantation era.

Transcatheter aortic valve implantation (TAVI) is thought to change the characteristics and outcome of patients with aortic stenosis undergoing surgical aortic valve replacement (SAVR). We investigated the difference in clinical characteristics and outcomes of SAVR patients in the TAVI era. Two cohorts of consecutive patients undergoing isolated SAVR for severe tricuspid aortic stenosis, in 4 years before (period-1) and 4 years after (period-2) the introduction of TAVI were analysed. Primary endpoint of 1-year mortality by Cox proportional hazard models was analysed. Secondary endpoints included 1-year, 30-day mortality and adverse perioperative events. The study consisted of 207 patients in period-1 and 200 in period-2. Mean age was 74.9 ± 9.6 and 73.5 ± 9.4 years in periods 1 and 2, respectively. Mean EuroSCORE was 11.5 ± 10.3 during period-1 vs. 8.4 ± 7.2 during period-2 (P = 0.001). One-year mortality decreased from 15.5 to 7.5% (P = 0.013). Composite of major adverse perioperative complications dropped from 12.6 to 6% (P = 0.027). EuroSCORE was an independent predictor of 30-day and 1-year mortality in period-1 (P < 0.005 for both) and not in period-2. Chronic pulmonary disease and preoperative atrial fibrillation were also independent predictors of 1-year mortality in period-1 only, although lower haemoglobin predicted mortality in both periods. We show a dramatic decrease in 1-year mortality and adverse perioperative events in patients undergoing SAVR for severe aortic stenosis during recent years. This change is likely related to selection of lower-risk patients for AVR in the TAVI era.

143 AN ALL-EMBRACING ANALYSIS COMBINING THE UK TAVI AND CARDIAC SURGICAL REGISTRIES (IN NICOR) TO DESCRIBE THE ACTIVITY, TREND AND OUTCOMES IN 36 026 PATIENTS WHO UNDERWENT AORTIC VALVE INTERVENTION IN THE 5 YEARS FROM 2006 TO 2010

Purpose Transcatheter aortic valve implantation (TAVI), allows treatment of patients with aortic stenosis for whom there were previously no therapeutic options available (or only at prohibitive risk). This, and evolving population demographics, have resulted in a rapid change in the overall management of all patients with aortic valve disease. The purpose of this study was to describe trends in activity levels, demographics and clinical outcomes of all patients who underwent aortic valve implantation (by surgical or catheter based approaches) during the first few years of TAVI roll out in England and Wales. Methods All cardiac surgical procedures and all catheter based implants (TAVIs) in the UK are entered into National Registries hosted by NICOR (National Institute for Cardiovascular Outcomes Research). These Registries have the same infrastructure and contain the same demographic data with compatible definitions. All aortic valve interventions over 5 years between 1 January 2006 and 31 December 2010 were included in this analysis, which was restricted to England and Wales where near 100% mortality tracking could be effected for both Registries. Results 35 406 patients underwent surgical AVR (isolated or with concomitant CABG) (SAVR); 1620 underwent TAVI. The numbers of SAVR peaked in 2008 then declined slightly (for the first time ever in the UK). There was a steady growth in TAVI, so that by 2010 TAVI represented just over 10% of all interventions for aortic stenosis. For patients >80 years old there was almost a 100% increase in all aortic valve interventions (from 1055 up to 2035 in 2010). This increase was about 50% due to an increase in TAVI and 50% SAVR. There was a very marked variation in the rate of uptake of TAVI by geographical region ranging from 1.4 to 36 pmp (rising to between 4.3 and 47 pmp in 2011). The TAVI cohort had a much greater risk profile even in the patients >80 years old. The 30 day and 1 year mortality was predictably higher in the TAVI cohort but this decreased markedly from 13.9% in 2007 to 6.2% in 2010. The trends in the timing of death post procedure between the conventional and TAVI groups will be presented, as will the 2011 data which will have been validated by January 2013 (a further >1000 TAVI procedures). Conclusions By capturing all procedures in England and Wales, this study provides a detailed insight into the evolution of aortic intervention during the introduction of TAVI in a defined population.

Emerging indications, in-hospital and long-term outcome of balloon aortic valvuloplasty in the transcatheter aortic valve implantation era

The introduction of transcatheter aortic valve implantation (TAVI) has generated a renewed interest in the treatment of high-risk patients with severe aortic stenosis. This study describes the indications and long-term outcome of balloon aortic valvuloplasty (BAV) in recent years. Between 2000 and 2010, 415 consecutive patients at our institution underwent BAV. The number of BAV per year increased sharply after the introduction of TAVI. Patients were 77.5±10.9 years old and showed important comorbidities (average logistic EuroSCORE=23.9±15.3%). We identified four cohorts according to the indications: 1) bridge for TAVI (B-TAVI; n=162); 2) bridge for aortic valve replacement (B-AVR, n=97); 3) cardiogenic shock (n=23); 4) palliation (n=133). Baseline characteristics were significantly different among groups. In-hospital mortality was 5.1%, and occurred predominantly in patients who underwent BAV in the setting of cardiogenic shock (56.5% vs. around 2% in the other subgroups). Other major events were stroke (0.5%), major vascular complications (2.2%), and life-threatening bleedings (1.5%). The cumulative one-year and two-year mortality rates were 33.2% and 57.4%, respectively, with the highest incidence in the shock group (70.7% and 80.4%) and the lowest in the B-AVR group (21.7% and 38.4%). Rehospitalisation for heart failure was 26.3% at one-year and 47.2% at two-year follow-up. The number of BAV is increasing, mainly due to increased referral of high-risk patients and to the emerging indication of bridge for TAVI. In this complex population, BAV is relatively safe but two-year survival remains poor, and more effective and definitive treatments should be pursued in a timely fashion.

The impact of transcatheter aortic valve implantation on patients' profiles and outcomes of aortic valve surgery programmes: a multi-institutional appraisal

The aim of this retrospective multicenter study was to assess how the development of transcatheter aortic valve implantation (TAVI) influenced the characteristics and outcomes of patients undergoing aortic valve procedures. We reviewed 1395 patients who underwent isolated surgical aortic valve replacement (SAVR) or TAVI in three centres with a high-volume TAVI programme. Patients were divided into two groups: 'Pre-TAVI' (395 patients, 28.3%) and 'Post-TAVI' (1000 patients, 71.7%) operated on before and after the introduction of TAVI into clinical practice. We evaluated age, logistic EuroSCORE I (LES) and hospital mortality according to time periods and the procedure performed, whether SAVR or TAVI. 'Post-TAVI' patients were older (78.2 ± 7.8 vs 76.8 ± 6.7 years; P = 0.002) and with a significantly higher LES (17.8 ± 14.7 vs 9.1 ± 9.2%; P < 0.001) than 'Pre-TAVI' patients. Hospital mortality was not significantly different between groups ('Pre-TAVI' vs 'Post-TAVI': 2 vs 3.4%; P = 0.17). Of the 1000 'Post-TAVI' patients, 605 (60.5%) underwent TAVI and 395 (39.5%), SAVR. Patients undergoing TAVI were older (79.9 ± 7.1 vs 75.5 ± 9.2 years; P < 0.001) and with a higher LES (22.9 ± 15.3 vs 9.7 ± 9.3%; P < 0.001) than 'Post-TAVI' SAVR patients, but their hospital mortality was similar (3.9 vs 2.5%; P = 0.22). LES was similar between 'Pre-TAVI' and 'Post-TAVI' SAVR patients (9.1 ± 9.2 vs 9.7 ± 9.3%; P = 0.26). Furthermore, we did not find significant differences in the overall hospital mortality between SAVR and TAVI patients: 2.3 vs 3.9%, P = 0.08. This analysis shows that the development of TAVI has caused an increase in the preoperative risk profile of patients scheduled for aortic valve procedures (SAVR or TAVI) without increasing hospital mortality.

Abstract 19309: What is the Impact of Transcatheter Aortic Valve Implantation on Patients' Profile and on Outcomes of Aortic Valve Surgery Programs? A Multi-Institutional Appraisal

Objective: Aim of this retrospective multicenter study was to assess how the introduction of transcatheter aortic valve implantation (TAVI) influenced the characteristics and the outcomes of patients undergoing aortic valve procedures. Methods: We analyzed data from 1395 patients who underwent isolated surgical aortic valve replacement (SAVR) or TAVI in 3 centers with a high-volume TAVI program. We considered two different time periods: “Pre-TAVI”, 395 patients (28.3%) operated on before the introduction of TAVI and “Post-TAVI”, 1000 patients (71.7%) operated on after the introduction of TAVI into clinical practice. We evaluated patients’ age, preoperative risk stratification (logistic Euroscore) and hospital mortality according to time periods and to the procedure performed. Results: “Post-TAVI” patients were older (78.2±7.8 vs 76.8±6.7 years; p=0.002) and with a significantly higher risk profile (Logistic Euroscore: 17.8±14.7% vs 9.1±9.2%; p&lt;0.001) when compared to “Pre-TAVI” patients. However, hospital mortality was not significantly different between groups (“Pre-TAVI”: 8 patients, 2% vs “Post-TAVI”: 34 patients, 3.4%; p=0.17). Out of the 1000 “Post-TAVI” period patients, 605 (60.5%) underwent TAVI and 395 (39.5%) underwent SAVR. Patients undergoing TAVI were older (79.9±7.1 vs 75.5±9.2 years; p&lt;0.001) and had a higher Euroscore (22.9±15.3% vs 9.7±9.3%) than “Post-TAVI” SAVR patients but their hospital mortality was similar (24 patients, 3.9% vs 10 patients, 2.5%; p=0.22). Preoperative risk stratification was similar between “Pre-TAVI” and “Post-TAVI” SAVR patients (9.1±9.2% vs 9.7±9.3%; p=0.26). Furthermore, we did not find significant differences in the overall hospital mortality between SAVR and TAVI patients: 18 patients, 2.3% vs 24 patients, 3.9%, p=0.08. Conclusions: The development of TAVI has determined an increase of preoperative risk profile of patients scheduled for aortic valve procedures (SAVR or TAVI) without increasing hospital mortality. TAVI patients were older and with higher Euroscore than SAVR patients but hospital mortality was similar. Therefore these data justify the introduction of TAVI into routine practice since it allows treatment of high risk patients without an adverse impact on mortality.

The Next Revolution: Percutaneous Aortic Valve Replacement

Aortic valve replacement (AVR) is a treatment of choice for patients with symptomatic severe aortic stenosis (AS). However, a significant proportion of these patients do not undergo surgical AVR due to high-risk features. Transcatheter aortic valve implantation (TAVI) has emerged as an alternative for patients with severe AS who are not candidates for open-heart surgery. Since the introduction of TAVI to the medical community in 2002, there has been an explosive growth in procedures. The balloon-expandable Edwards SAPIEN valve and the self-expanding CoreValve ReValvingTM system contribute the largest patient experience with more than 10,000 patients treated with TAVI to date. Clinical outcomes have stabilized in experienced hands, with 30-day mortality less than 10%. Careful patient selection, growing operator experience, and an integrated multidisciplinary team approach contribute to notable improvement in outcomes. In the first randomized pivotal PARTNER trial, in patients with severe AS not suitable candidates for surgical AVR, TAVI compared with standard therapy, significantly improved survival and cardiac symptoms, but was associated with higher incidence of major strokes and major vascular events. The results of randomized comparison of TAVI with AVR among high-risk patients with AS for whom surgery is a viable option are eagerly awaited to provide further evidence on the applicability of TAVI in these patients.

093 Treatment of high risk aortic stenosis in 2010—more than just TAVI

Introduction The treatment of high risk patients with severe aortic stenosis (AS) has been transformed by the availability of transcatheter aortic valve implantation (TAVI) alongside conventional high risk aortic valve replacement (AVR). Selection of patients for this procedure is clinically challenging and best achieved using a dedicated and experienced multidisciplinary team (MDT). A TAVI programme was established at our institution in September 2008 and the MDT from the outset comprised two interventional cardiologists, an imaging specialist, two cardiac surgeons, cardiac anaesthetist, general cardiologist and a nurse specialist. We report the MDT decision and outcome of 135 patients referred over the subsequent 15 months and the implication on service provision for all aspects of the management of AS. Methods Clinical details of all patients referred to the high-risk aortic stenosis MDT were recorded and analysed prospectively. Outcome data were derived from the hospital database. Results One thirty five patients (mean age 82 years, 50% male) were referred to the high-risk AS MDT (51% local cardiologists, 4% local surgeons, 34% DGH, 11% out of region). Many patients were referred with sufficient data to allow decision making and 45 underwent detailed assessment prior to consideration of TAVI (either following an index inpatient event or during elective admission). To date, 29 of the 135 referred (20%, mean logistic Euroscore 20%) have undergone TAVI (nine apical and 20 femoral) with one (3.4%) procedural mortality, 30-day survival rate 90% and post-TAVI permanent pacemaker requirement 31%. Ten patients (mean logistic Euroscore 22%) were unsuitable for TAVI but appropriate for palliative balloon valvuloplasty either due to significant left ventricular impairment or the presence of co-existent disease with impact on life expectancy. This procedure was undertaken with no in-hospital mortality, a mean reduction in trans-valvular gradient of 25% and a 30-day mortality of 5%. Thirteen patients (mean logistic Euroscore 17.6%) have been referred for high risk AVR. There was one death (8%) 47 days post-AVR. Continued medical therapy was recommended in 27 patients (20 excessive risk or unsuitable for TAVI or valvuloplasty, seven non-severe AS or alternative irreversible aetiology for symptoms eg, pulmonary disease). Overall 12-month mortality for the entire cohort was 20%, highest mortality being seen in those patients deemed too high risk for any form of intervention (41%). Two patients died of AS while the TAVI programme was being conceived. Conclusion Many patients with severe AS previously felt to be at excess risk for any intervention may be suitable for TAVI, surgical AVR or balloon valvuloplasty. Careful patient selection undertaken by a specialist MDT leads to excellent survival outcomes even in this high-risk patient population. The introduction of TAVI has increased surgical referral for AVR and re-introduced balloon valvuloplasty as a successful method of treatment.