Progress and Current Status of Percutaneous Aortic Valve Replacement: Results of Three Device Generations of the CoreValve Revalving System

Abstract

Background— Percutaneous aortic valve replacement is a new emerging technology for interventional treatment of severe aortic valve stenosis in surgical high-risk patients. This study was intended to provide a summary of the development and current safety and efficacy status of the self-expanding CoreValve Revalving prosthesis. Method and Results— Between 2005 and 2008, we have enrolled 136 consecutive patients with percutaneous aortic valve replacement using the CoreValve prosthesis. In this prospective nonrandomized, single-center trial, we analyzed procedural outcome, complications and clinical status up to 1 year. First, second, and third generation of the CoreValve prosthesis were implanted in 10, 24, and 102 consecutive high-risk patients (logistic EuroScore: 23.1�15.0%) with severe symptomatic aortic valve stenosis. Mean transvalvular pressure gradient was 41.5�16.7 mm Hg. The procedural success rate increased from generation 1/2 to 3 from 70.0%/70.8% to 91.2% ( P =0.003). The 30-day combined rate of death/stroke/myocardial infarction was 40.0%/20.8%/14.7% ( P =0.11) for generation 1, 2, and 3, with no procedural death in generation 3. Pressure gradients improved significantly with a final mean gradient of 8.1�3.8 mm Hg. Overall functional status assessed by New York Heart Association class improved from 3.3�0.5 (pre) to 1.7�0.7 (post) ( P <0.001) and remained stable in the follow-up. Conclusion— In experienced hands, percutaneous aortic valve replacement with the CoreValve system for selected patients with severe aortic valve stenosis has a high acute success rate associated with a low periprocedural mortality/stroke rate as well as remarkable clinical and hemodynamic improvements, which persist over time. Additional studies are now required to confirm these findings, particularly head-to-head comparisons with surgical valve replacement in different risk populations.

Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study)

“…7,8 The procedures were performed according to standard local hospital practices, which included the selection of access location (transfemoral, or subclavian), the type of access (surgical cutdown or completely percutaneous), and the type of anesthesia (GA or non-GA). Procedural characteristics analyzed for the comparisons between anesthesia groups included access type and site, procedure duration, fluoroscopy time, quantity of contrast agent used, procedural complications, and length and type of hospital stay.…”

Transcatheter Versus Surgical Aortic Valve Replacement

“…Rates of death in the transcatheter group at 30 days (3.4% in the intention-to-treat analysis and 5.2% in the as-treated analysis) were also excellent, as compared with earlier results in the PARTNER trial in patients who were not candidates for surgical valve replacement 35 and with data from other registries of transcatheter replacement. [24][25][26][29][30][31][32][33][34] As in previous observational studies of transcatheter Subgroup analyses are shown for the primary end point of death from any cause at 1 year among patients in the intention-to-treat population who were randomly assigned to undergo either transcatheter aortic-valve replacement or surgical aortic-valve replacement. The P value for interaction represents the likelihood of interaction between the variable and the relative treatment effect.…”

“…[22][23][24][25][26][27][28][29][30][31][32][33][34] In the randomized Placement of Aortic Transcatheter Valves (PARTNER) trial, a subgroup of patients with aortic stenosis who were not candidates for surgical aortic-valve replacement and who underwent transfemoral placement had an improvement of 20% in the 1-year survival rate and also had reduced symptoms. 35 This report describes results for the highrisk subgroup of patients in the PARTNER trial who were still candidates for surgical valve replacement and who were randomly assigned to undergo either transcatheter or surgical replacement of the aortic valve.…”

Manejo anestésico e complicações no implante percutâneo de válvula aórtica

“…The anesthetic technique remains uncertain, as there are schools using the deep sedation technique, others using general anesthesia, and still another school using combined epidural anesthesia with sedation 4,[12][13][14][15][16] . General anesthesia and deep sedation have been used in several studies with good results 4,10,[16][17][18][19][20][21][22][23][24][25][26][27] . In our case series, we used general anesthesia due to the need for prolonged immobilization of patients in uncomfortable tables, tendency for hypothermia, the team's learning curve, need for surgical repair of catheterized arteries, TEE use, possibility of neurological complications and surgical intervention with cardiopulmonary bypass (CPB), and little knowledge on the technique.…”