Permanent Pacemaker Implantation Following Valve-in-Valve Transcatheter Aortic Valve Replacement: VIVID Registry.

BACKGROUND: Permanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs). OBJECTIVES: The goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures. METHODS: Data were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs. RESULTS: A total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups). CONCLUSIONS: In a contemporary large series of ViV-TAVR patients, the rate of periprocedural PPI was relatively low, and its incidence decreased with the use of new-generation THV systems. PPI following ViV-TAVR was associated with a trend toward increased mortality at follow-up.

The effect of transcatheter aortic valve implantation approaches on mortality.

OBJECTIVES: We aimed to evaluate the effect of transcatheter aortic valve implantation (TAVI) approaches on mortality and identify effect modifiers and predictors for mortality. BACKGROUND: Alternative access routes to transfemoral (TF) TAVI include the surgical intra-thoracic direct-aortic (DA) and transapical (TA) approach. TA TAVI has been associated with a higher mortality rate. We hypothesized that this is related to effect modifiers, in particular the left ventricular ejection fraction (LVEF). METHODS: This multicentre study derived its data from prospective registries. To adjust for confounders, we used propensity-score based, stabilized inverse probability weighted Cox regression models. RESULTS: In total, 5,910 patients underwent TAVI via TF (N = 4,072), DA (N = 524), and TA (N = 1,314) access. Compared to TF, 30-day mortality was increased among DA (HR 1.87, 95%CI 1.26-2.78, p = .002) and TA (HR 3.34, 95%CI 2.28-4.89, p < .001) cases. Compared to TF, 5-year mortality was increased among TA cases (HR 1.50, 95%CI 1.24-1.83, p < .001). None of the variables showed a significant interaction between the approaches and mortality. An impaired LVEF (≤35%) increased mortality in all approaches. CONCLUSIONS: The surgical intra-thoracic TA and DA TAVI are both associated with a higher 30-day mortality than TF TAVI. TA TAVI is associated with a higher 5-year mortality than TF TAVI. The DA approach may therefore have some advantages over the TA approach when TF access is not feasible.

Causes of death in intermediate-risk patients: The Randomized Surgical Replacement and Transcatheter Aortic Valve Implantation Trial.

OBJECTIVES: Examine the causes and timing of death in the Surgical Replacement and Transcatheter Aortic Valve Implantation intermediate-risk randomized trial for transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). METHODS: Causes of death were adjudicated by an independent clinical event committee and by post-hoc hierarchical classification. Causes of death were evaluated and characteristics and procedural parameters compared between patients who died and survivors for 3 time periods: early (0-30 days), recovery (31-120 days), and late (121-365 days). RESULTS: All-cause mortality at 1 year was 6.5% after TAVR and 6.7% after SAVR. There were no differences in mortality rates between TAVR and SAVR for any of the 3 time periods. Early mortality was primarily due to technical, procedure-related problems in TAVR and due to complications in SAVR. For TAVR and SAVR, most deaths during recovery were caused by complications. Other causes, including comorbid conditions, accounted for most late deaths. CONCLUSIONS: Mortality rates were similar for patients treated with TAVR or SAVR at any time period including at 1 year. Early cause of death was more commonly technical failure after TAVR and due to complications after SAVR. Recovery phase cause of death was dominated by complications from TAVR and SAVR. Late cause of death appeared to be independent of the procedure in both groups.

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

AIMS: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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.

Impact of Pre-Existing Prosthesis-Patient Mismatch on Survival Following Aortic Valve-in-Valve Procedures.

OBJECTIVES: The aim of this study was to determine whether the association of small label size of the surgical valve with increased mortality after transcatheter valve-in-valve (ViV) implantation is, at least in part, related to pre-existing prosthesis-patient mismatch (PPM) (i.e., a bioprosthesis that is too small in relation to body size). BACKGROUND: Transcatheter ViV implantation is an alternative for the treatment of patients with degenerated bioprostheses. Small label size of the surgical valve has been associated with increased mortality after ViV implantation. METHODS: Data from 1,168 patients included in the VIVID (Valve-in-Valve International Data) registry were analyzed. Pre-existing PPM of the surgical valve was determined using a reference value of effective orifice area for each given model and size of implanted prosthetic valve indexed for body surface area. Severe PPM was defined according to the criteria proposed by the Valve Academic Research Consortium 2: indexed effective orifice area <0.65 cm2/m2 if body mass index is <30 kg/m2 and <0.6 cm2/m2 if BMI is ≥30 kg/m2. The primary study endpoint was 1-year mortality. RESULTS: Among the 1,168 patients included in the registry, 89 (7.6%) had pre-existing severe PPM. Patients with severe PPM had higher 30-day (10.3%, p = 0.01) and 1-year (unadjusted: 28.6%, p < 0.001; adjusted: 19.3%, p = 0.03) mortality rates compared with patients with no severe PPM (4.3%, 11.9%, and 10.9%, respectively). After adjusting for surgical valve label size, Society of Thoracic Surgeons score, renal failure, diabetes, and stentless surgical valves, presence of pre-existing severe PPM was associated with increased risk for 1-year mortality (odds ratio: 1.88; 95% confidence interval: 1.07 to 3.28; p = 0.03). Patients with severe PPM also more frequently harbored high post-procedural gradients (mean gradient ≥20 mm Hg). CONCLUSIONS: Pre-existing PPM of the failed surgical valve is strongly and independently associated with increased risk for mortality following ViV implantation.

A meta-analysis on clinical outcomes after transaortic transcatheter aortic valve implantation by the Heart Team.

AIMS: We aimed to perform a meta-analysis on transaortic (TAo) transcatheter aortic valve implantation (TAVI) in order to gain more insight into the safety and efficacy of the approach in addition to the data available from selected centres with small numbers of patients. METHODS AND RESULTS: PubMed and EMBASE were searched on 31 August 2016. The search yielded 251 studies, of which 16 with 1,907 patients were included in the meta-analysis. All were observational, single-arm studies. The rate of conversion to sternotomy was 3.2% (95% CI: 2.3-3.5%; I2=0) among nine studies. Device success among 10 studies was 91% (95% CI: 86.7-94.0%; I2=25.5). Major vascular complications occurred at a rate of 3.1% (95% CI: 1.6-6.0%; I2=60.8). Moderate or severe paravalvular leakage/aortic valve regurgitation (PVL/AR) was reported to be 6.7% (95% CI: 4.3-10.1%; I2=58.9). Permanent pacemaker implantation was required in 11.7% (95% CI: 9.2-14.8%; I2=26.5) of patients. Pooled 30-day post-TAVI complication rates were 9.9% (95% CI: 8.6-11.3%; I2=0) for mortality, 3.7% (95% CI: 2.4-5.6%; I2=28.7) for all stroke, and 1.0% for myocardial infarction (95% CI: 0.5-1.7%; I2=0). The Valve Academic Research Consortium-2 (VARC-2) composite safety endpoint occurred at a pooled rate of 16.7% (95% CI: 10.6-25.3%; I2=58.7). CONCLUSIONS: In this meta-analysis of observational studies, transaortic TAVI appears to be a safe procedure with low complication rates.

Matched Comparison of Self-Expanding Transcatheter Heart Valves for the Treatment of Failed Aortic Surgical Bioprosthesis: Insights From the Valve-in-Valve International Data Registry (VIVID).

BACKGROUND: Transcatheter valve-in-valve implantation is an established therapy for high-risk patients with failed surgical aortic bioprosthesis. There are limited data comparing outcomes of valve-in-valve implantation using different transcatheter heart valves (THV). METHODS AND RESULTS: Patients included in the Valve-in-Valve International Data registry (VIVID) and treated with self-expanding THV devices were analyzed using centralized core laboratory blinded to clinical events. St. Jude Medical Portico versus Medtronic CoreValve were compared in a 1:2 fashion after propensity score matching. A total of 162 patients, Portico- (n=54) and CoreValve- (n=108) based valve-in-valve procedures comprised the study population with no significant difference in baseline characteristics (age, 79±8.2 years; 60% women; mean STS [Society of Thoracic Surgery] score 8.1±5.5%). Postimplantation, CoreValve was associated with a larger effective orifice area (1.67 versus 1.31 cm2; P=0.001), lower mean gradient (14±7.5 versus 17±7.5 mm Hg; P=0.02), and lower core laboratory-adjudicated moderate-to-severe aortic insufficiency (4.2% versus 13.7%; P=0.04), compared with Portico. Procedural complications including THV malpositioning, second THV requirement, or coronary obstruction were not significantly different between the 2 groups. Survival and stroke rates at 30 days were similar, but overall mortality at 1 year was higher among patients treated with Portico compared with CoreValve (22.6% versus 9.1%; P=0.03). CONCLUSIONS: In this first matched comparison of THVs for valve-in-valve implantations, Portico and CoreValve demonstrated differences in postprocedural hemodynamics and long-term clinical outcomes. Although this could be related to THV design characteristics, the impact of other procedural factors cannot be excluded and require further evaluation.

One-Year Outcomes of Transcatheter Aortic Valve Implantation Using the Direct Aortic Approach.

BACKGROUND: The direct aortic (DA) approach allows for transcatheter aortic valve implantation (TAVI) in patients with difficult peripheral vascular anatomy. The CoreValve ADVANCE Direct Aortic (ADVANCE DA) study was performed to assess the outcomes of DA TAVI with the CoreValve System (Medtronic, Minneapolis, MN) in routine practice. METHODS: Patients were selected for the DA approach by local cardiac surgical teams, and TAVI was performed with patients under general anesthesia. Safety events were adjudicated according to the Valve Academic Research Consortium-2 definitions by an independent clinical events committee. All imaging data, including that from multislice computed tomography and follow-up echocardiography, were analyzed by an independent core laboratory. RESULTS: From September 2012 to February 2014, 100 patients were enrolled (52.0% male, age 81.9 ± 5.9 years, The Society of Thoracic Surgeons Score 5.9 ± 3.2%) at 9 centers in Europe. Peripheral vascular disease was present in 51.0% of patients, and 38.0% had diabetes. Of the 100 patients enrolled, 92 underwent TAVI. At 30 days after TAVI, 98.1% were free of moderate or severe paravalvular leak. At 1 year, 16 patients had died (Kaplan-Meier rate 17.9%), 1 (1.1%) patient had had a stroke, classified as nondisabling, and 15 (17.0%) patients had received a permanent pacemaker. Most patients experienced improved quality of life as measured by the Kansas City Cardiomyopathy Questionnaire overall summary score (mean change from baseline to 1 year, 39.6 ± 26.3; p < 0.01). CONCLUSIONS: The DA approach provides a feasible alternative for patients with challenging anatomic features that may otherwise preclude use of the TAVI procedure.

Transcatheter Aortic Valve Replacement Using the Portico System: 10 Things to Remember.

The Portico system (St. Jude Medical, Minneapolis, MN, USA) consists of a self-expanding valve prosthesis and a delivery system designed for transcatheter aortic valve replacement (TAVR). We describe this system, its 10-steps implantation procedure, and provide tips and tricks based on our personal experience with this system.

Transcatheter aortic valve implantation using a direct aortic approach: a single-centre Heart Team experience.

OBJECTIVES: The transaortic (TAo) approach has been introduced as an alternative to transapical and transaxillary aortic valve implantation for patients with symptomatic severe aortic stenosis in whom a transfemoral approach is not feasible. However, only very limited data from a minimal number of specialized centres are available on this approach. Therefore, the aim of this study was to evaluate the early postoperative 30-day outcomes of the direct aortic approach performed by a single-centre multidisciplinary Heart Team. METHODS: Between May 2011 and July 2013, 159 patients underwent transcatheter aortic valve implantation (TAVI) at our institution; of which, 44 were believed to benefit most from the TAo as assessed by a multidisciplinary Heart Team. All patients underwent an upper 'J' median hemi-sternotomy through a 6-cm incision. The evaluation of early operative results was made according to the Valve Academic Research Consortium (VARC) consensus criteria. These include device success endpoints and combined safety endpoints at 30 days. RESULTS: The mean age of the patients was 78 years, the mean logistic EuroSCORE was 25.9 ± 14.4% and the mean Society of the Thoracic Surgeons score 5.8 ± 4.5%. Seventeen patients (39%) underwent redo operations; 4 (9%) received a transcatheter valve in a degenerated bioprosthesis. The procedure was performed using the Medtronic CoreValve Revalving system in 36 patients, with the Edwards SAPIEN XT in 7 cases and the St Jude Medical Portico valve in 1. Device success was achieved in 90.8% of the cases. Complications included; major stroke (n = 1), re-exploration for cardiac tamponade (n = 3), transient renal failure requiring temporary haemodialysis (n = 1) and permanent pacemaker implantation (n = 5). There were no myocardial infarctions. The total 30-day mortality rate was 6.8% (3 patients). Postoperative intensive care unit stay was 2.6 ± 3.6 days, and the mean hospitalization was 12 ± 9.6 days. CONCLUSIONS: The TAo TAVI approach is feasible and offers a safe alternative for patients in whom a transfemoral approach is not feasible or desirable.

Transcatheter aortic valve implantation in patients with severe aortic valve stenosis and large aortic annulus, using the self-expanding 31-mm Medtronic CoreValve prosthesis: first clinical experience.

OBJECTIVES: With the introduction of the 31-mm Medtronic CoreValve prosthesis, patients with large aortic annulus have become eligible for transcatheter aortic valve implantation. The aim of this study was to evaluate the feasibility, efficacy, and safety of transcatheter aortic valve implantation using the 31-mm Medtronic CoreValve in patients with severe aortic valve stenosis and large aortic annulus. METHODS: Five institutions in the Netherlands and Italy participated in a retrospective multicenter registry. Clinical, procedural, and imaging data of patients treated with the 31-mm Medtronic CoreValve were retrospectively collected in accordance with the Valve Academic Research Consortium-2 criteria. RESULTS: Between August 2011 and November 2012, 47 patients (44 men, mean age 77.6 ± 8.9 years) received the 31-mm Medtronic CoreValve prosthesis for severe aortic stenosis. Device success (correct positioning of a single valve with intended performance and no all-cause 30-day mortality) was achieved in 31 patients (66.0%). Reasons for failing the device success criteria were significant prosthetic aortic regurgitation in 3 patients (6.4%), second valve implantation in 10 patients (21.2%) (8 cases of malpositioning with high-grade aortic regurgitation, 1 acute valve dislocation, and 1 delayed valve dislocation), 1 of whom died intrahospital, and in-hospital mortality in a further 3 patients (6.4%). Peak and mean transaortic gradients decreased significantly (P < .01). The rate of new pacemaker implantations was 41.7%. CONCLUSIONS: In this retrospective multicenter registry, transcatheter treatment of severe aortic valve stenosis with the 31-mm Medtronic CoreValve seemed to be challenging, even in experienced hands. If the prosthesis is properly implanted, it offers adequate valve hemodynamics and proper functioning.

Minimally invasive transaortic transcatheter aortic valve implantation of the CoreValve prosthesis: the direct aortic approach through a mini-sternotomy.

Transcatheter implantation of the CoreValve bioprosthesis (Medtronic, Minneapolis, MN, USA) can be performed surgically through a minimally invasive approach: using an upper-J mini-sternotomy to the second or third intercostal space, the ascending aorta is exposed at a convenient location. After placing two purse-string sutures on the ascending aorta at least 7 cm above the aortic valve annulus, the CoreValve delivery system is advanced under fluoroscopy to the optimal position and the valve is deployed. Because of the short distance between the access point and the aortic annulus, positioning of the valve can be done more accurately in comparison with the transfemoral approach. We report a brief description of this surgical technique, its indications and limitations and the short-term results of our first series.