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In the early 1990s, the idea of Transcatheter Aortic Valve Implantation (TAVI) emerged from clinicians by the insight that the long-term hemodynamic and clinical results of aortic balloon valvuloplasty to treat aortic stenonosis were not satisfying. Thus, Anderson and Cribier developed the balloon-expandable and Figulla and Laborde the self-expendable TAVI systems. Sceptical views by the surgical colleagues and the industry delayed the rapid development of this disruptive new therapy until 2002, when Alain Cribier demonstrated for the first time the proof of his concept. Bulky devices and paravalvular leakages in patients treated in terms of compassionate care resulted in high mortality rates. From 2005 onwards, the treatment of patients not at highest risk using smoother devices in clinical trials could demonstrate that the technology was equivalent to surgical aortic valve replacement. The transapical access route initiated the heart team approach with the surgical colleagues, however, this access route is presently expiring due to its greater trauma. The need to treat also aortic regurgitation is addressed by the "clipping technology" of JenaValve™. Ongoing clinical trials investigate an extended indication for TAVI at an earlier stage of aortic stenosis, or in reduced ejection fraction, and just demonstrated the safety and efficiency even in low surgical risk patients.

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Patients with severe aortic stenosis who require non-cardiac surgery present a difficult clinical problem. The most recent clinical practice guidelines from the American College of Cardiology/American Heart Association and the European Society of Cardiology for the perioperative cardiovascular assessment and management of patients undergoing noncardiac surgery were both published in 2014. These guidelines are reviewed in the light of recently published randomised controlled trial data regarding the efficacy of transcatheter aortic valve implantation to treat aortic stenosis.

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BACKGROUND: Transcatheter aortic valve implantation (TAVI) has rapidly evolved to the standard-of-care for inoperable patients with severe, symptomatic aortic valve stenosis, and to an alternative treatment option for high-risk patients. However, the randomized PARTNER trial excluded patients with conditions frequently encountered in daily clinical practice. METHODS: From 2006 to 2011, 467 high-risk patients, who underwent transfemoral TAVI (Edwards Sapien n = 166; Medtronic CoreValve n = 301) at two German centers were divided into a "PARTNER-like" (n = 227) and a "Real-World" cohort (n = 240), based on the original PARTNER trial in- and exclusion criteria. Differences in 30-day and 2-year mortality and morbidity were assessed. RESULTS: Mean age of patients was 80 ± 8 years with a logistic EuroSCORE of 22 ± 16%. The most frequent exclusion criteria were previous PCI (15.4%), prior valve surgery (13.7%), chronic renal failure (12.0%), and severe mitral regurgitation (10.8%). Despite significant differences in baseline data, estimated perioperative mortality in terms of STS and logistic EuroScore was identical between both groups. However, patients in the "Real-World" cohort had a non-significant trend towards a higher 30-day mortality (10.0% vs. 6.7%, P = 0.088) and a significantly higher 2-year mortality (23.3% vs. 14.5%, P = 0.016) compared with patients of the "PARTNER-like" cohort. CONCLUSION: Patients meeting PARTNER study exclusion criteria had an acceptable outcome at 30 days and 2 years, however, with significant differences to "PARTNER-like" patients. Still, our results indicate that also real-life patients with relevant comorbidities, who would have been excluded from the randomized PARTNER trials, benefit from TAVI with acceptable short- and long-term outcome.

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As the French population is aging, a growing number of elderly patients with symptomatic severe aortic stenosis are going to require therapeutic management. Approximately 30 to 40 % of these patients do not undergo surgical treatment and a high proportion is considered to be at high risk for surgery. The transluminal aortic valve implantation technique has been increasingly used over the past few years, thus providing a solution to a major therapeutic issue in our industrialized countries. Thanks to major randomized studies such as the PARTNER US trial, this treatment has been approved for high-risk patients. Expertise and new devices are now opening the way to intermediate risk population.

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BACKGROUND: Transapical (TA) aortic valve replacement was an integral part of the Placement of Transcatheter Aortic Valves (PARTNER) trial. Enrollment during the randomized trial included 104 transapical (premarket approval TA [PMA-TA]) and 92 surgical aortic valve replacements (SAVR) within the TA cohort. On completion of the trial, enrollment continued in a nonrandomized continued access (NRCA) program. We compared the outcomes of NRCA-TA procedures with those of PMA-TA and SAVR. METHODS: In 22 centers, 975 patients underwent TA aortic valve replacement as part of the NRCA registry. Inclusion and exclusion criteria were unchanged from the previously reported PARTNER trial. All patients were followed up for at least 1 year. RESULTS: Thirty-day or in-hospital mortality was 8.8% for the NRCA-TA cohort, compared with 10.6% and 12.0% for the PMA-TA and SAVR patients, respectively (p = 0.54). One-year mortality in the NRCA-TA cohort was 22.1%, not significantly lower than the mortality in PMA-TA and SAVR patients at 29.0% and 25.3%, respectively (p = 0.27). Thirty-day or in-hospital stroke was 2.2% among NRCA-TA patients in contrast to the 6.7% stroke rate observed in the PMA-TA group and 5.4% in SAVR patients (p = 0.008). Lower rates of neurologic adverse events in the NRCA-TA group persisted at 1 year compared with the PMA-TA and SAVR patients. CONCLUSIONS: Among the 975 patients in the NRCA-TA cohort, rates of major outcomes including death and stroke compared favorably with outcomes of PMA-TA and SAVR patients enrolled in the PARTNER trial. This trend toward improved outcomes may be attributed to improved patient selection, individual centers surmounting the procedural learning curve, and refinements in surgical technique.

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Conventional aortic valve replacement (AVR) surgery has been in clinical use since 1960. Results, particularly in high-risk populations such as the very elderly and frail, continue to improve in response to the challenges posed by this growing segment of the patient population. Transcatheter aortic valve implantation (TAVI) is a fairly recent development, performed for the first time in 2002. The last decade has seen an exponential growth in the application of this technology in higher-risk populations. Results of recent randomized prospective trials demonstrate both the future promise and current problems of the TAVI approach. Many patients deemed inoperable for AVR have been treated successfully by TAVI. However, elevated procedural and late mortality rates, excessive early and late stroke, and a significant incidence of periprosthetic aortic valve insufficiency and patient-prosthesis mismatch all suggest caution in extending this technology to patients able to undergo conventional AVR with a low risk of early or late complications.

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Transcatheter aortic valve replacement (TAVR) has proven to be a viable tool for the high-surgical-risk population with severe aortic valve stenosis. Vascular access complications are not uncommon with TAVR and may increase early and late mortality. Avoiding these serious complications is the goal. With experience and careful screening, we are now able to risk-stratify patients who may be at increased risk of vascular complications. While the traditional iliofemoral access site remains the most common for TAVR, alternate access sites that have proven to be viable and safe alternatives include the transapical, direct-aortic, and subclavian techniques. TAVR teams should be familiar and comfortable with these approaches as each of them has its own advantages and weaknesses. The best option is usually one in which the procedure is tailored to the patient. The present review examines our current access planning and strategies for TAVR.

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Transcather aortic valve replacement (TAVR) has rapidly gained worldwide acceptance for treating very high-risk patients with symptomatic severe aortic stenosis. Two valve systems are currently in common use worldwide and under trial in the United States. The Edwards SAPIEN valve has completed its PARTNER trial and has been approved for use in nonoperative patients. The Medtronic CoreValve is currently completing its US pivotal trial. Both plan studies of intermediate-risk patients. The use of TAVR in Europe has grown rapidly and is now about 23% of the total aortic valve replacements done in which a tissue valve is chosen (generally patients over 60 to 65 years of age). This technology is used in a patient population that was either not receiving any surgical therapy due to extreme risk or was considered very high risk for conventional surgery. The procedure requires a highly trained TAVR team, advanced imaging, and the devices themselves, which are expensive. Medical device trials are generally designed to establish if the device works as planned. For TAVR in today's world of rising health care costs, the additional question of cost effectiveness is important to address. Fortunately, the PARTNER trial addressed this and the CoreValve trial has built this into the trial design as well. This article examines what is currently known about the cost-effectiveness of TAVR.

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