Indications for Transcatheter Aortic Valve Replacement Based on the PARTNER Trial (original) (raw)
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Revista Brasileira de cardiologia invasiva, 2012
background: One third of the elderly population with symptomatic calcified aortic stenosis cannot undergo surgery due to their high operative risk. The transcatheter aortic-valve implantation (TAVI) has emerged as an alternative therapy for this group of patients. Methods: All patients submitted to TAVI from November 2008 to April 2012 were included in our study. We report the baseline clinical characteristics, procedural data, hospital outcomes and clinical follow-up of this population. Definitions were based on the Valve Academic Research Consortium criteria. Results: TAVI was performed in 23 patients, with 79 ± 6.7 years of age, and 56% were female. The EuroSCORE was 20.4 ± 11.1%. The CoreValve ® prosthesis was used in 19 patients (82.6%) and the Edwards SAPIEN™ valve was used in the remaining ones. Procedure success rate was 96%. The mean follow-up was 22 ± 12.8 months, with 6 deaths (26.1%) in this period, 3 of which were observed in the first 30 days (13%) and other 2 (21.7%) by the end of the first year. One patient had a transient ischemic attack during hospitalization (4.3%), but there were no episodes of stroke or myocardial infarction in the periprocedural period or in the follow-up. The composite safety endpoint at 30 days was observed in 5 patients (21.7%) and the composite efficacy endpoint at 12 months was 78.3%. Conclusions: The results of this study demonstrate that TAVI is an attractive procedure for
2015
Introduction: Aortic stenosis (AS) is the most common form of heart valve disease in the western world. As the population ages, this disease is becoming an increasing burden on patients and on the health care system. Current drug therapies (medical management (MM)) cannot reverse the course of AS. For most individuals with severe AS, surgical aortic valve replacement (SAVR), which requires open heart surgery and cardiopulmonary bypass, remains the standard therapy. However, a subgroup of patients with aortic stenosis are unsuitable for or at high risk to undergo SAVR due to their frailty or other comorbidities. Transcatheter aortic valve implantation (TAVI)-a novel, less invasive treatment option-was developed as an alternative for patients who are not suitable or at high risk for undergoing surgery. Objective: This study is intended to assess the feasibility, safety, efficacy and clinical effectiveness of TAVI, using the transfemoral (TF) and transapical (TA) approaches, in comparison to medical management or SAVR in patients with severe symptomatic AS; and to compare the outcomes associated with the two different approaches for valve implantation (TF and TA). Methods: A comprehensive literature search was conducted using eight electronic databases to identify studies of TAVI (TF and/or TA) for the treatment of AS. Data from the selected studies were extracted by two reviewers. Outcomes considered were feasibility, safety, efficacy and effectiveness of TAVI. Study quality was assessed and information was tabulated to identify trends or patterns. Results were pooled across studies for each outcome. iii Results: Fifty six relevant studies were identified: 37 studies (including seven comparative studies) assessed clinical outcomes, 14 studies discussed health-related quality of life, and five studies examined the impact of the learning curve on feasibility and safety of TAVI on patient outcomes. The overall procedural success rate was 96% (88%-100%). Studies that examined the learning curve for TAVI demonstrated it had a significant impact-increasing the procedural success rate and decreasing 30-day mortality. The mean combined periprocedural and cumulative all-cause mortality rate at 30 days for TAVI compared to the control groups (MM and/or SAVR) in the same or different studies was 9.0%, n = 10,500 vs 2.8%, n = 179, and 6.7%, n = 302, respectively. Permanent pacemaker implantation was three times more common with the Medtronic CoreValve compared to the Edwards SAPIEN prosthesis (26.5% vs 8.2%), but when both TAVI valves were compared with SAVR, there was no statistically significant difference. Major vascular complications occurred more frequently in the TF group (11.6%) than in the MM, SAVR or the TA groups. The rate of acute kidney injury requiring renal replacement therapy did not differ significantly between the TAVI and control groups, but was three times higher with the TA compared to the TF approach (7.3% vs 2.5%). TAVI achieved significant hemodynamic improvement as measured by echocardiography. The pooled estimate for moderate or severe paravalvular aortic regurgitation after TAVI was 7.2% (with no significant difference between TAVI approaches). Paravalvular aortic regurgitation occurred more frequently with TAVI than with SAVR. One year survival rates ranged from 68% to 77% for TAVI patients in the comparative studies and 72% to 85.3% in the case series studies. For MM and SAVR, the one year iv survival rate was 45% to 49.7% and 73.4% to 83%, respectively. Studies that compared patients' quality of life before and after TAVI found significant improvement at one-year follow-up. Conclusions: TAVI offers a safe and effective treatment for severe aortic stenosis in patients who are not suitable for or are at high risk to undergo SAVR. Unfortunately, current shortcomings in the evidence on long term outcomes make it difficult to determine the effectiveness of TAVI in high risk patients who may be candidates for surgery. v
Implementation of a TAVI Program: How and Why
It has been about a decade since the first transcatheter aortic valve implantation that took place in 2002 by Cribier, since then several approaches have been developed in order to create the best one for each patient's criteria. As Aortic stenosis is the most common valvular disease and as the numbers of patients are increasing as the age expectancy of the population is increasing, the need of a TAVI team is mandatory. This research is conducted to analyse the TAVI techniques available, its complications and the role of a multidisciplinary team. The review included different medical trials and literature reviews published in the years
Annals of cardiothoracic surgery, 2017
Transcatheter aortic valve implantation/replacement (TAVI/TAVR) is becoming more frequently used to treat aortic stenosis (AS), with increasing push for the procedure in lower risk patients. Numerous randomized controlled trials have demonstrated that TAVI offers a suitable alternative to the current gold standard of surgical aortic valve replacement (SAVR) in terms of short-term outcomes. The present review evaluates long-term outcomes following TAVI procedures. Literature search using three electronic databases was performed up to June 2017. Studies which included 20 or more patients undergoing TAVI procedures, either as a stand-alone or concomitant procedure and with a follow-up of at least 5 years, were included in the present review. Literature search and data extraction were performed by two independent researchers. Digitized survival data were extracted from Kaplan-Meier curves in order to re-create the original patient data using an iterative algorithm and subsequently aggre...
Journal of Cardiovascular Medicine, 2014
Aims Transcatheter aortic valve implantation (TAVI) is increasingly considered as a viable alternative to conventional aortic valve replacement (AVR) in high-risk patients. Long-term results, however, are still scarce and medical community hesitates in enlarging indications to lower-risk patients. Moreover, available devices are expensive and a strict potential candidate selection is necessary.
Early Experience of Transaortic TAVI���The Future of Surgical TAVI?
2012
Background: Trans-catheter aortic valve implantation (TAVI) is now a well recognised procedure for the high risk surgical patient with native or bioprosthetic aortic valve stenosis. Transfemoral and transapical implantation techniques are well described. With increasing referral of more marginal transapical patients, we describe our experience of a transaortic TAVI approach which we believe reduces the postoperative wound pain, respiratory complications, operative risk and hospital stay. Methods: Patients referred for surgical TAVI underwent trans-catheter aortic valve implantation via an upper sternotomy and direct cannulation of the ascending aorta. Results: Thirteen patients with a mean age of 81 years underwent transaortic Edwards SAPIEN valve implantation. There was no in hospital mortality in our series. One patient required insertion of a permanent pacemaker for complete heart block. There were no aortic cannulation complications. Conclusion: The transaortic TAVI approach provides good exposure of the distal ascending aorta, a familiar cannulation site for cardiac surgeons. Our initial experience demonstrates the approach to be a safe technique with the potential for faster and less complicated recovery in patients undergoing surgical TAVI procedures. With further experience and greater acceptance, the transaortic approach may ultimately become the procedure of choice for patients unsuitable for a transfemoral approach.
New devices for TAVI: technologies and initial clinical experiences
Nature reviews. Cardiology, 2014
Treatment of aortic stenosis in high-risk surgical patients has been modified in the past 10 years owing to the introduction of transcatheter aortic valve implantation (TAVI). Several issues affecting outcomes with implantation of the first-generation TAVI devices remain unresolved, including haemorrhagic and vascular complications, neurological events, rhythm disturbances, and paravalvular leakage. Further technological improvements are, therefore, required before the indications for TAVI can be extended to young and low-risk patients with aortic stenosis. Many new-generation TAVI devices are currently in the early stages of clinical evaluation. Modifications in the new devices include the ability to reposition the valve before final deployment, features to reduce paravalvular leakage, and the introduction of low-profile delivery systems. The aim of this Review is to provide an overview of the new-generation transcatheter valvular technologies, including initial clinical reports.