Feasibility and Initial Results of Percutaneous Aortic Valve Implantation Including Selection of the Transfemoral or Transapical Approach in Patients With Severe Aortic Stenosis

doi:10.1016/j.amjcard.2008.06.061

The American Journal of Cardiology

Volume 102, Issue 9, 1 November 2008, Pages 1240-1246

https://doi.org/10.1016/j.amjcard.2008.06.061 Get rights and content

The purpose of this study was to evaluate the feasibility and initial results of a multidisciplinary percutaneous aortic valve implantation (PAVI) program including the transfemoral approach (TFA) and the transapical approach (TAA). This was a prospective registry including all patients with symptomatic severe aortic stenosis who were evaluated for PAVI and those who finally underwent the procedure. All patients were considered very high risk or nonsurgical candidates, and an algorithm based on prespecified criteria was used to determine the most appropriate approach (TFA vs TAA) for each patient. The Edwards-Sapien valve was used in all cases, and all procedures were performed without cardiopulmonary bypass. A total of 29 consecutive patients were evaluated for PAVI, and 22 of them underwent the procedure (mean age 84 ± 7 years, predicted surgical mortality 26 ± 16%), with 11 patients selected for each approach. Reasons for selecting TAA rather than TFA were the following: small diameter and/or severe calcification of the iliofemoral arteries (4 patients), peripheral vascular disease (4 patients), porcelain aorta (2 patients), and horizontal ascending aorta (1 patient). Successful aortic valve implantation was obtained in 91% of the procedures, and procedural and 30-day mortality were 4.3% and 8.7%, respectively. There were no cases of myocardial infarction, vascular complications, or cerebrovascular accident. PAVI was associated with a significant reduction in mean aortic gradient (baseline 34 ± 10 mm Hg, postprocedure 9 ± 3 mm Hg, p <0.001), with no cases of severe aortic regurgitation. After a median follow-up period of 6 months, there were no additional major adverse cardiac events, and no significant changes in hemodynamic aortic valve parameters were observed. In conclusion, this study demonstrates the feasibility and low complication rate of a PAVI program using a prospective strategy for the selection of the TFA or TAA, with half of the patients selected for each approach.

Section snippets

Patients

The study was a prospective registry including all patients evaluated for PAVI and those who finally underwent the procedure at our center from April 2007 to January 2008. PAVI has been approved for compassionate clinical use by the Department of Health and Welfare (Ottawa, Ontario, Canada) in patients with symptomatic severe aortic stenosis considered nonoperable or at very high surgical risk. All patients provided informed consent for the procedures.

The potential candidates for PAVI underwent

Results

A total of 29 patients were screened for PAVI during the study period, and 24 of them (83%) were finally accepted for the procedure (Figure 1). Reasons for excluding patients for PAVI were the following: significant cognitive impairment due to Alzheimer's dementia (1 patient), concomitant severe mitral structural disease (1 patient), Child's class B hepatic cirrhosis (1 patient), very poor physical condition with extremely limited mobility (1 patient), and patient's refusal (1 patient). Two of

Discussion

This study demonstrates the feasibility and good preliminary results of a multidisciplinary PAVI program that involves the systematic use of a decision algorithm for the selection of the most suitable approach (TFA vs TAA) in a given patient. Such a program implies a multidisciplinary approach, with close collaboration between cardiac surgeons and interventional cardiologists. Although only half of the patients were considered eligible for the TFA, having the TAA as an alternative allowed us to

Acknowledgment

We would like to thank Jacinthe Aubé, RN, and Stephanie Dionne, RA, for their exceptional work on data collection and patient follow-up. Dr. Josep Rodés-Cabau is a consultant for Edwards Lifesciences Inc.

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Developing the technique of percutaneous implantation of aortic valves (TAVI) for the treatment of degenerative aortic stenosis: Where are we and what future for TAVI?
2023, Bulletin de l'Academie Nationale de Medecine
Le TAVI (Transcatheter Aortic Valve Implantation) est une innovation française, initiée en 2002 par l’équipe de cardiologie du CHU de Rouen et dont on célèbre cette année le 20^e anniversaire. Cette technique consiste à implanter une prothèse valvulaire au sein de la valve aortique calcifiée du rétrécissement valvulaire dégénératif de l’adulte (RAC) en utilisant des techniques usuelles de cathétérisme cardiaque. Le RAC est la maladie valvulaire acquise la plus fréquente de l’adulte, touchant principalement les sujets âgés. Sa prévalence augmente avec l’âge, concernant environ 7 % de la population au-dessus de 75 ans, ce qui est considérable. De très nombreux patients ne peuvent pas bénéficier du seul traitement possible, le remplacement valvulaire chirurgical (RVA), en raison de leur grand âge ou de comorbidités. Ces patients sont voués à une mort certaine à court terme, 80 % dans les trois ans après l’apparition des premiers symptômes. Ceci a motivé notre intérêt pour le développement de techniques alternatives interventionnelles moins invasives que le RVA, d’abord la dilatation percutanée aortique au ballonnet avec un premier cas mondial à Rouen en 1985, puis le TAVI afin de pallier les limitations de cette première approche. Le développement de cette procédure, a été une fascinante odyssée de vingt ans dont les principales étapes sont rappelées dans cet article. Cette technique, dont la seule évocation soulevait les pires critiques, a connu un succès considérable et une expansion mondiale qui défie l’imagination. Ceci a résulté de la combinaison d’avancées technologiques continuelles depuis le premier cas et d’une évaluation scientifique des plus rigoureuses par d’innombrables registres contrôlés, mais également par plusieurs études randomisées successives contre le RVA chez des patients à risque chirurgical dégressif. La non-infériorité ou la supériorité du TAVI par rapport au RVA sur l’amélioration des patients et la mortalité à moyen et long terme ont ainsi pu être constamment démontrés, ce qui a créé un nouveau paradigme pour l’approche thérapeutique du RAC. À l’heure actuelle, le TAVI peut être proposé en première intention à tout patient âgé de plus de 65 ans aux USA et de plus de 75 ans en Europe, quel que soit le risque chirurgical, le RVA restant indiqué pour les patients non candidats au TAVI. Plus de 1,5 million de patients ont été traités par TAVI dans le monde et une croissance de 4 à 10 % est prévue annuellement. Depuis 2019, le nombre de TAVI dépasse celui du RVA dans plusieurs pays dont les USA. Les effets collatéraux de cette technologie de rupture sur les pratiques médicales et sur le développement de nombreuses techniques interventionnelles pour d’autres maladies valvulaires ou structurelles myocardiques sont notables. À cet égard, l’histoire du TAVI pourrait constituer une grande source d’inspiration pour tous les jeunes médecins et chercheurs qui se vouent à l’amélioration des techniques médicales.
The TAVI (Transcatheter Aortic Valve Implantation) is a French innovation, initiated in 2002 by the cardiology team of Rouen University Hospital and whose 20th anniversary is being celebrated this year. This technique consists of implanting a valve prosthesis within the native aortic valve of adults suffering from calcific degenerative aortic stenosis (AS) using standard cardiac catheterization techniques. AS is the most frequent acquired valvular disease of adults, mainly affecting the elderly. Its prevalence increases with age, concerning about 7% of a population older than 75 years, which is considerable. Many patients cannot benefit fromthe only possible treatment, surgical aortic valve replacement (SAVR), a heavy open-heart surgery, due to their advanced age or comorbidities. These patients are doomed to early death, 80% within three years after the onset of the first symptoms. This has motivated our interest for the development of less invasive interventional techniques, such as balloon aortic valve dilatation in 1985, then TAVI in order to overcome the limitations of the first approach. The development of TAVI was a fascinating 20-year odyssey, the main stages of which are summarized in this article. This technique, the mere mention of which raised the worst criticisms, has known a considerable success and a worldwide expansion that defy the imagination. This has resulted from the combination of continuous technological advances since the first case, with rigorous scientific evaluation using a number of controlled registries, but also by several several successive randomized studies comparing TAVI to SAVR in patients at decreasing surgical risk. The non-inferiority or superiority of TAVI on patients improvement and mortality at mid- and long-term could be consistently demonstrated and this led to a change in paradigm for the treatment of AS. Currently, TAVI is being validated for any patient, whatever the surgical risk, older than 65 years in the USA or 75 years in Europe, whereas SAVR remains indicated for patients who are not optimal candidates to TAVI. More than 1.5 million patients have been treated with TAVI worldwide and a growth of 4 to 10% per year is predicted. Since 2019, the number of TAVI exceeds that of SAVR in several countries including the USA. Finally, the collateral effects of this breakthrough technology on medical practice and on the development of other valvular and structural interventional techniques is particularly noteworthy. In this regard, the history of TAVI should be very inspiring for the young clinicians and scientists aimed at improving medical therapies.
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Calcification of the ascending aorta complicates aortic valve replacement. Transcatheter aortic valve replacement is an alternative procedure in this situation, but it requires manipulation through the hostile area in the ascending aorta. We reviewed our transcatheter aortic valve insertion experience to better understand the surgical mortality risk of valve insertion in patients with extensive calcification of the ascending aorta.
We retrospectively reviewed the records of 665 consecutive patients who received transcatheter aortic valve insertion from November 2008 through December 2015. We defined a hostile ascending aorta on the basis of preoperative computed tomography scan documenting significant aortic calcification that the surgeon believed precluded safe aortic cross-clamp application. There were 36 patients (5%) who met our definition of a hostile ascending aorta (hostile aorta group) and 629 (95%) who did not (control group).
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Transcatheter aortic valve insertion can be performed with low procedure-related morbidity and mortality in patients with hostile calcification of the ascending aorta. Our data support a transfemoral-first paradigm in this patient population.
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TAVI is a percutaneous approach to aortic valve replacement in high surgical risk patients deemed inoperable.
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Acute kidney injury (AKI) frequently occurs following transcatheter aortic valve implantation (TAVI) and has been related to a worse outcome. We investigated the importance of contrast medium composition, either iso-osmolar (IOCM) or low-osmolar (LOCM) and assessed predictors for AKI after TAVI.
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Despite the minimally invasive nature of transcatheter aortic valve implantation (TAVI), the incidence of acute kidney injury (AKI) and mortality is of major concern. Several studies showed that outcome was influenced by the systemic inflammatory response syndrome (SIRS) in patients undergoing percutaneous TAVI. The purpose of this study was to investigate whether SIRS after transapical TAVI was associated with short-term outcome.
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none.
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Valvular heart diseaseFeasibility and Initial Results of Percutaneous Aortic Valve Implantation Including Selection of the Transfemoral or Transapical Approach in Patients With Severe Aortic Stenosis

Section snippets

Patients

Results

Discussion

Acknowledgment

J Am Coll Cardiol

J Am Coll Cardiol

J Thorac Cardiovasc Surg

Ann Thorac Surg

Transapical transcatheter aortic valve implantation in humansInitial clinical experience

Circulation

Minimally invasive transapical beating heart aortic valve implantation – proof of concept

Eur J Cardiothorac Surg

Valvular heart disease
Feasibility and Initial Results of Percutaneous Aortic Valve Implantation Including Selection of the Transfemoral or Transapical Approach in Patients With Severe Aortic Stenosis