The concept of transcatheter aortic valve replacement was developed with the goal of offering a therapeutic solution to patients with severe symptomatic aortic stenosis who are not considered good ...candidates for surgical valve replacement. Initial attempts were complicated by vascular access problems and lack of appropriate tools. With time and experience, early problems were solved and the concepts of valve sizing, valve positioning, and patient selection were defined. Technological improvements allowed the use of smaller arterial sheaths to decrease vascular trauma, special catheters to facilitate valve delivery, and treatments on the valve prostheses that would ensure longer durability. After 5 years, the number of transcatheter aortic valve replacements has grown significantly, and will likely continue as this technology becomes increasingly available. Currently, 2 valve models, the Edwards SAPIEN valve (Edwards Lifescience, Irvine, California) and the CoreValve ReValving system (CoreValve Inc., Irvine, California), have been used in over 4,000 cases worldwide for the treatment of symptomatic aortic stenosis. Midterm follow-up shows no evidence of restenosis or prosthetic valve dysfunction. Transfemoral and transapical delivery routes can be selected depending on the quality of vascular access and the type of prosthesis used. Randomized trials that are currently underway will confirm procedural safety and guide the applicability of this technology.
Intermediate-risk patients with aortic stenosis were randomly assigned to undergo either transcatheter or surgical aortic-valve replacement. At 5 years, there was no significant difference between ...the two groups in the incidence of death or disabling stroke. The incidence of aortic regurgitation was higher with transcatheter AVR.
In a randomized trial involving more than 2000 patients, transcatheter aortic-valve replacement was noninferior to surgical replacement in the primary end point of death from any cause or disabling ...stroke at 2 years.
Transcatheter aortic-valve replacement (TAVR) is a new therapy for patients with severe aortic stenosis who are not candidates for surgery
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or who are at high risk for complications due to surgery.
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The acceptance of the use of TAVR in high-risk patients was based on evidence from clinical trials
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that used early-generation TAVR devices; these procedures were associated with considerable procedure-related complications.
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Recently, increased operator experience and enhanced transcatheter valve systems have led to a worldwide trend to use TAVR in patients who are at low or intermediate risk.
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This trend has been evaluated in small . . .
Neurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP).
This study evaluated the safety and efficacy of ...TCEP during TAVR.
Nineteen centers randomized 363 patients undergoing TAVR to a safety arm (n = 123), device imaging (n = 121), and control imaging (n = 119). The primary safety endpoint consisted of major adverse cardiac and cerebrovascular events (MACCE) at 30 days, and the primary efficacy endpoint was reduction in new lesion volume in protected brain territories on magnetic resonance imaging scans at 2 to 7 days. Patients underwent neurocognitive assessments, and the debris captured was analyzed.
The rate of MACCE (7.3%) was noninferior to the performance goal (18.3%, pnoninferior < 0.001) and not statistically different from that of the control group (9.9%; p = 0.41). New lesion volume was 178.0 mm3 in control subjects and 102.8 mm3 in the device arm (p = 0.33). A post hoc multivariable analysis identified pre-existing lesion volume and valve type as predictors of new lesion volume. Strokes at 30 days were 9.1% in control subjects and 5.6% in patients with devices (p = 0.25) Neurocognitive function was similar in control subjects and patients with devices, but there was a correlation between lesion volume and neurocognitive decline (p = 0.0022). Debris found within filters in 99% of patients included thrombus, calcification, valve tissue, artery wall, and foreign material.
TCEP was safe, captured embolic debris in 99% of patients, and did not change neurocognitive function. Reduction in new lesion volume on magnetic resonance scans was not statistically significant. (Cerebral Protection in Transcatheter Aortic Valve Replacement SENTINEL; NCT02214277)
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This study provides 2-year data from the PARTNER trial, in which patients with aortic stenosis received transcatheter aortic-valve replacement (TAVR) or surgical replacement. Overall mortality was ...similar, but paravalvular leak increased mortality in the TAVR group.
Aortic stenosis is associated with high mortality after the appearance of cardiac symptoms.
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Nevertheless, many patients do not undergo surgical aortic-valve replacement owing to real or perceived increased risks associated with surgery.
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Transcatheter aortic-valve replacement (TAVR) has emerged as an alternative therapy in high-risk patients with aortic stenosis.
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Observational registries from various countries have reported 1-month and 1-year outcomes after TAVR,
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but there are limited long-term follow-up data.
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The Placement of Aortic Transcatheter Valves (PARTNER) trial was a randomized trial comparing TAVR with standard-of-care therapies in high-risk patients with aortic stenosis. One-year mortality outcomes from PARTNER showed . . .
Background Although preoperative renal dysfunction (RD) is associated with increased mortality and morbidity after surgical aortic valve replacement, its impact on clinical outcomes after ...transcatheter aortic valve replacement (TAVR) is less defined. Methods TAVR patients in the PARTNER (Placement of Aortic Transcatheter Valves) trial with a calculable glomerular filtration rate (GFR) using the Modification of Diet in Renal Disease equation were included. Patients were divided into three groups: GFR >60 mL/min (none/mild RD), GFR 31 to 60 mL/min (moderate RD), and GFR ≤30 mL/min (severe RD). Operative characteristics and clinical outcomes were analyzed. Cox regression models were used to determine multivariable predictors of 1-year all-cause mortality. Results A total of 2,531 inoperable or high surgical risk patients from the PARTNER trial and continued access registries had a calculable GFR level: 767 (30%) had normal renal function or mild RD, 1,473 (58%) had moderate RD, and 291 (12%) presented with severe RD. The mean Society of Thoracic Surgeons Predicted Risk of Mortality for the cohort was 11.5%, and it was highest in those with severe RD (13.8%). Patients with severe RD were more often women with a higher prevalence of diabetes. Patients with severe RD had the highest incidence of 30-day and 1-year all-cause mortality and rehospitalization. The 30-day rate of death from any cause was 10.7% in the severe RD group versus 6.0% in the moderate and mild RD groups ( p = 0.01). The 1-year rate of death from any cause was 34.4% in the severe RD group versus 21.5% in the moderate RD and 20.8% in the none/mild RD groups (adjusted hazard ratio HR 2.24, p < 0.0001 for severe versus none/mild; adjusted HR 1.14, p = 0.24 for severe versus moderate). Other significant predictors of 1-year all-cause mortality included lower body mass index, frailty, the transapical approach, a lower ejection fraction, oxygen-dependent chronic obstructive pulmonary disease, liver disease, and male sex. Conclusions Preoperative severe RD is a significant predictor for 1-year mortality in TAVR patients. Careful risk stratification by the heart team is required in patients with severe preprocedural RD.
Abstract Transcatheter aortic valve replacement (TAVR) has been shown to significantly impact mortality and quality of life in patients with severe aortic stenosis (AS) who are deemed high risk for ...surgical aortic valve replacement (SAVR). Essential to these outcomes is proper patient selection. The multidisciplinary TAVR heart team was created to provide comprehensive patient evaluation and aid in proper selection. This review with outline the history and components of the heart team, and delineate the team’s role in risk and frailty assessment, evaluation of common co-morbidities that impact outcomes, and the complex multi-modality imaging necessary for procedural planning and patient selection. The heart team is critical in determining patient eligibility and benefit and the optimal operative approach for TAVR. The future of structural heart disease will certainly require a team approach, and the TAVR heart team will serve as the successful model.
Abstract
Aims
In patients randomized to transcatheter or surgical aortic valve replacement (TAVR, SAVR), we sought to determine whether SAVR is associated with worsening right ventricular (RV) ...function and whether RV deterioration is associated with mortality.
Methods and results
In 1376 patients from PARTNERIIA with paired baseline and 30-day core lab echocardiograms, worsening RV function was defined as decline by at least one grade from baseline to 30 days. Our primary outcome was all-cause mortality from 30 days to 2 years. Among 744 patients with TAVR, 62 (8.3%) had worsening RV function, compared with 156 of 632 patients with SAVR (24.7%) (P < 0.0001). In a multivariable model, SAVR odds ratio (OR) 4.05, 95% confidence interval (CI) 2.55–6.44, a dilated RV (OR 2.38, 95% CI 1.37–4.14), and more than mild tricuspid regurgitation (TR) (OR 2.58, 95% CI 1.25–5.33) were associated with worsening RV function. There were 169 deaths, and patients with worsening RV function had higher all-cause mortality hazard ratio (HR) 1.98, 95% CI 1.40–2.79. This association remained robust after adjusting for clinical and echocardiographic variables. Among patients with worsening RV function, there was no mortality difference between TAVR and SAVR (HR 1.16, 95% CI 0.61–2.18). The development of moderate or severe RV dysfunction from baseline normal RV function conferred the worst prognosis (HR 2.87, 95% CI 1.40–5.89).
Conclusion
After aortic valve replacement, worsening RV function is more common in patients with baseline RV dilation, more than mild TR, and in patients treated with SAVR. Worsening RV function and the magnitude of deterioration have important prognostic implications.
Background Smaller transcatheter aortic valve replacement (TAVR) delivery systems have increased the number of patients eligible for transfemoral procedures while decreasing the need for transaortic ...(TAo) or transapical (TA) access. As a result, newer TAVR centers are likely to have less exposure to these alternative access techniques, making it harder to achieve proficiency. The purpose of this study was to evaluate the learning curve for TAVR approaches and compare perioperative outcomes. Methods From January 2008 to December 2014, 400 patients underwent TAVR (transfemoral, n = 179; TA, n = 120; and TAo, n = 101)). Learning curves were constructed using metrics of contrast utilization, procedural, and fluoroscopy times. Outcomes during the learning curve were compared with after proficiency was achieved. Results Depending on the metric, learning curves for all three routes differed slightly but all demonstrated proficiency by the 50th case. There were no significant differences in procedural times whereas improvements in contrast use were most notable for TA (69 ± 40 mL versus 50 ± 23 mL, p = 0.002). For both TA and TAo, fewer patients received transfusions once proficiency was reached (62% versus 34%, p = 0.003, and 42% versus 14%, p = 0.002, respectively). No differences in 30-day or 1-year mortality were seen before or after proficiency was reached for any approach. Conclusions The learning curves for TA and TAo are distinct but technical proficiency begins to develop by 25 cases and becomes complete by 50 cases for both approaches. Given the relatively low volume of alternative access, achieving technical proficiency may take significant time. However, technical proficiency had no effect on 30-day or 1-year mortality for any access approach.
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