Early Experience of Transaortic TAVI���The Future of Surgical TAVI? (original) (raw)
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First experience with the Edwards SAPIEN transcatheter aortic valve implantation (TAVI)
2012
Background: Transcatheter aortic valve implantation (TAVI) is an exciting new technology that was launched in South Africa in October 2009 for the treatment of aortic stenosis in patients at high risk for conventional surgery. We report our initial experience with TAVI in the Western Cape, South Africa. Methods: 70 patients with severe symptomatic aortic stenosis underwent TAVI with the Edwards SAPIEN device (26 via transapical approach and 44 via transfemoral) at Panorama and Vergelegen Mediclinic hospitals in the Western Cape. All implants were performed by a team consisting of 2 cardiothoracic anaesthesiologists, 2 cardiothoracic surgeons, 2 cardiologists and an echo expert. Results: Patients were at high risk with a mean age of 80 years and a mean logistic EuroSCORE of 26. The acute procedural success rate was 97% with two acute deaths. At 30 days, there were a total of 5 deaths. Major vascular complications were seen in 6 cases (9%). Only one stroke was seen during the follow-u...
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
Trans-Catheter Aortic Valve Implantation (Tavi)-A Case Series at Afic/Nihd
Pakistan Armed Forces Medical Journal, 2021
Objective: To share our experience of percutaneous trans-catheter aortic valve implantation in patients with severe symptomatic aortic stenosis. Study Design: A retrospective cross sectional study. Place and Duration of Study: The study was conducted at Armed Forces Institute of Cardiology/National Institute of Heart Diseases (AFIC/NIHD) Rawalpindi, from Mar 2015 to Feb 2020. Methodology: Retrospective analysis of all consecutive patients who underwent percutaneous trans-catheter aortic valve implantation was done to assess its immediate, short and long term outcome and safety. Twenty patients have undergone trans-catheter aortic valve implantation since 2015 in the institute. Base line blood chemistry including creatinine clearance, ultra-sonography abdomen, carotid Doppler, chest X-ray, High-Resolution Computed Tomography chest was done in all cases as part of the protocol. Mean age of the patients was 73 ± 7.91. There were sixteen males (80.0%) and four females (20.0%). All patie...
The American Journal of Cardiology, 2015
Many patients have ilio-femoral vessel anatomy unsuitable for conventional transfemoral (TF) trans-catheter aortic valve implantation (TAVI). Safe and practical alternatives to the TF approach are therefore needed. This study compared outcomes of alternative non-femoral routes, trans-apical (TA), direct aortic (DA) and subclavian (SC), with standard femoral access. In this retrospective study, data from 3,962 patients in the UK TAVI registry were analysed. All patients who received TAVI via a femoral, subclavian, transapical or direct aortic approach were eligible for inclusion. The primary outcome measure was survival up to two years. Median Logistic EuroSCORE was similar for SC, DA, and TA, but significantly lower in the TF cohort (22.1% vs 20.3% vs 21.2% vs 17.0% respectively, p<0.0001). Estimated oneyear survival was similar for TF (84.6±0.7%) and SC (80.5±3%, p=0.27), but significantly worse for TA (74.7±1.6%, p<0.001) and DA (75.2±3.3%, p<0.001). A Cox proportional hazard model was used to analyse survival up to 2-years. Survival in the SC group was not significantly different to the TF group (HR 1.22, 95% CI 0.88-1.70, p=0.24). In contrast, survival in the TA (HR 1.74, 95% CI 1.43-2.11;p<0.001) and DA (HR 1.55, 95% CI 1.13-2.14; p<0.01) cohorts was significantly reduced compared to TF. In conclusion, trans-apical and direct aortic TAVI were associated with similar survival, both significantly worse than with the trans-femoral route. In contrast, subclavian access was not significantly different to trans-femoral, and may represent the safest non-femoral access route for TAVI.
Unexpected Complications of Transapical Aortic Valve Implantation
The Annals of Thoracic Surgery, 2009
Background. Recent series have reviewed the results of transapical aortic valve implantation (TAVI). However, specific problems of this new procedure are not welldescribed. Unexpected complications due to the procedure and their management are reported. Methods. Eighteen patients underwent TAVI using the Edwards Sapien bioprosthesis (Edwards Lifesciences Inc, CA) between September 2007 and June 2008 due to contraindications of conventional surgery (n ؍ 5) or high operative risk (n ؍ 13). The system was introduced through 2 purse string sutures in the apex under echocardiographic and fluoroscopic control. Results. The implantation success rate and initial procedural success were 100%. There was no intraoperative death and no stroke. During the procedure, two cases of ventricular fibrillation consequent to rapid pacing were treated by cardioversion. Acute mitral regurgitation due to traction of the subvalvular apparatus by the guidewire and acute aortic regurgitation from pressure on a bioprosthesis cusp by the guidewire were diagnosed by transesophageal echocardiography and reversed by the removal of the guidewire. Another case of aortic regur-gitation was due to incomplete deployment of the bioprosthesis and was managed by a "valve after valve" procedure. Two patients died on postoperative day 2 from left ventricular failure. In one patient the postmortem study showed, despite correct implantation of the bioprosthesis, a hematoma of the septum with a small ventricular septal defect. The total in-hospital death was 27.7% (5 patients). There was no periprocedural bleeding but in one patient delayed rupture of the apex (36 hours after the procedure) necessitated emergency surgery. A false aneurysm of the apex appeared 3 months after surgery in another patient. Closure of the apex was performed through sternotomy and cardiopulmonary bypass with an uneventful follow-up. Conclusions. The TAVI is associated with incidents and complications different to those encountered in conventional aortic valve surgery. Recognizing their existence contributes to elucidating their mechanisms and to propose solutions to avoid or treat them.
Transapical Aortic Valve Implantation in High-Risk Patients With Severe Aortic Valve Stenosis
The Annals of Thoracic Surgery, 2011
Background. Transapical aortic valve implantation (TA-TAVI) represents an alternative in patients with symptomatic severe aortic valve stenosis (SSAVS) who cannot be operated on or have a high surgical risk. The aim of this prospective multicenter observational study was to assess early and 2-year clinical and hemodynamic outcomes after TA-TAVI.
2018
Transcatheter aortic valve implantation (TAVI) has become the treatment of choice in patients with severe symptomatic aortic stenosis (AS) considered inoperable or at high surgical risk. More recently, TAVI has been performed also to lower risk patients based on the Heart Team decision. Few studies have studied interaction between surgical risk categories and outcomes. Aim of the study To analyze safety and efficacy (VARC-2 defined) TAVI treated patients as function of different preoperative risk. To assess independent predictors of death. Methods Four-hundred-eighty-two patients who underwent TAVI in our center between 2007 and 2017 were included in the study. According to Society of Thoracic Surgeons (STS) score and to other parameters, all the patients were retrospectively stratified into 4 groups: prohibitive (contraindications to aortic valve replacement, n = 124), high (STS > 8, n = 131), intermediate (4 ≤ STS ≤ 8, n = 112) and low (STS < 4, n = 115) risk. Early, 1-year ...
Transapical Versus Transfemoral Aortic Valve Implantation: A Comparison of Survival and Safety
The Annals of Thoracic Surgery, 2011
Background. Transcatheter aortic valve implantation (TAVI) is a therapeutic option for high-risk patients with aortic stenosis. Procedural mortality remains high in comparison with conventional aortic valve replacement (AVR) because patients determined for TAVI are commonly denied conventional surgery. We aimed to evaluate access-related complications between the transfemoral (TF) and the transapical (TA) approach and to compare survival between TAVI and conventional AVR in propensity-score-matched patients.