Fig 3 - uploaded by David Paniagua
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Aortic and ventricular pressure traces A) before and B) after percutaneous heart valve implantation.
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The transcatheter route is an emerging approach to treating valvular disease in high-risk patients. The 1st clinical antegrade transcatheter placement of an aortic valve prosthesis was reported in 2002. We describe the first retrograde transcatheter implantation of a new aortic valve prosthesis, in a 62-year-old man with inoperable calcific aortic...
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... implantation and fluoroscopy procedures took 130 and 22 minutes, respectively. After the valve was deployed, the patient's hemodynamic values improved significantly. The aortic pressure increased from 80/ 50 to 110/60 mmHg, and the transvalvular gradient decreased from 36 to <5 mmHg (Fig. 3). Immediate- ly after valve expansion, a complete atrioventricular block occurred, and cardiac pacing was required for 45 seconds, after which the heart spontaneously re- turned to sinus rhythm. The cardiac output increased from 1.0 to 2.8 L/min (later, 4.8 L/min), and urine production increased to 200 ...
Citations
... TAVR has undergone a significant evolution over the past two decades, highlighted in Figure 2. The first TAVR procedure in humans was reported in 2002, using an antegrade transseptal approach in a patient with severe aortic stenosis, multiple comorbidities, and cardiogenic shock, who had a prior balloon aortic valvuloplasty with restenosis [6]. The first retrograde TAVR in humans using a transfemoral arterial access was performed in Venezuela in 2005 in a patient with severe aortic stenosis and acute decompensated heart failure refractory to medical therapy [7]. Shortly after, in 2006, the first case of transapical TAVR was performed in a patient with severe aortic stenosis, with prohibitive surgical risk, that was not a candidate for transfemoral access due to a large infrarenal aortic aneurysm and bilateral aortoiliac disease [8]. ...
Transcatheter aortic valve replacement (TAVR) has emerged as an alternative treatment option for patients with severe aortic stenosis regardless of surgical risk, particularly in those with a high and prohibitive risk. Since the advent of TAVR, transfemoral access has been the standard of care. However, given comorbidities and anatomical limitations, a proportion of patients are not good candidates for a transfemoral approach. Alternative access, including transapical, transaortic, transaxillary, transsubclavian, transcarotid, and transcaval, can be considered. Each alternative access has advantages and disadvantages, so the vascular route should be tailored to the patient’s characteristics. However, there is no standardized algorithm when choosing the optimal alternative vascular access. In this review, we analyzed the evolution and current evidence for the most common alternative access for TAVR and proposed an algorithm for choosing the optimal vascular access in this patient population.
... However, at month 4 postprocedure the patient passed away due to complicated lower limb ischemia. Paniagua and colleagues (2) in 2005 published the first retrograde TAVR experience in a 62 year-old suffering from severe AS with good immediate result but, yet again, the patient was sadly exitus vitae at day 2. ...
... 7 In 2002, Anderson et al. used TAVI in animals, 7 and later Cribier implanted a valve prosthesis via the transcatheter route in humans. 8 The method was improved by Webb who switched to the even less invasive route of placing the valve via retrograde arterial wall. 9 However, from the viewpoint of HVTE, the TAVI procedure brings forth new challenges. ...
The steady increase in the number of patients with diseased aortic valves demands the development
of effective aortic valve replacement procedures. Engineering and technology offer various
manufactured alternatives, but none can exactly match the natural human valve. In addition to the
experts of heart valve tissue engineering, many researchers focus on specific aspects of the
manufacturing of artificial valves. The aim of this study was to benefit such manufacturing processes.
From the contributor’s perspective, it is vital to gain comprehensive knowledge before embarking on
this project. The perfect/optimal shape of the valve is the fundamental aspect that needs to be
considered by all participants. It is noteworthy that the geometry not only limits the functionality of the structure but also determines the choice of material and engineering methods. In this study, we
attempt to determine if current knowledge is sufficient to reach consensus on the issue of the optimum
shape of the valve. Here, we not only provide a brief overview of traditional literature but also
include the opinions of experts. This innovative way of scientific communication is unprecedented
in scientific literature, and we hope that both professionals and contributors will find this study useful.
... Although this open, invasive procedure is not practicable to treat established human AKI, other intravascular approaches using endovascular catheters can effectively deliver solutions via retrograde delivery in large animal models and humans. [47][48][49][50][51][52] The proposed lack of no-reflow in large animal models as well as humans is often a point of contention with the use of various animal models in experimental AKI. [53][54][55][56][57] However, several of these studies described a lack of the no-reflow phenomenon where renal blood flow returned to baseline levels very early (e.g., 2 minutes) after reperfusion. ...
Highly aerobic organs like the kidney are innately susceptible to ischemia-reperfusion (I/R) injury, which can originate from sources including myocardial infarction, renal trauma, and transplant. Therapy is mainly supportive and depends on the cause(s) of damage. In the absence of hypervolemia, intravenous fluid delivery is frequently the first course of treatment but does not reverse established AKI. Evidence suggests that disrupting leukocyte adhesion may prevent the impairment of renal microvascular perfusion and the heightened inflammatory response that exacerbate ischemic renal injury. We investigated the therapeutic potential of hydrodynamic isotonic fluid delivery (HIFD) to the left renal vein 24 hours after inducing moderate-to-severe unilateral IRI in rats. HIFD significantly increased hydrostatic pressure within the renal vein. When conducted after established AKI, 24 hours after I/R injury, HIFD produced substantial and statistically significant decreases in serum creatinine levels compared with levels in animals given an equivalent volume of saline via peripheral infusion (P<0.05). Intravital confocal microscopy performed immediately after HIFD showed improved microvascular perfusion. Notably, HIFD also resulted in immediate enhancement of parenchymal labeling with the fluorescent dye Hoechst 33342. HIFD also associated with a significant reduction in the accumulation of renal leukocytes, including proinflammatory T cells. Additionally, HIFD significantly reduced peritubular capillary erythrocyte congestion and improved histologic scores of tubular injury 4 days after IRI. Taken together, these results indicate that HIFD performed after establishment of AKI rapidly restores microvascular perfusion and small molecule accessibility, with improvement in overall renal function.
... Soon after, Paniagua et al. attempted the first retrograde transfemoral implantation of an aortic valve [3]. This technique was further enhanced and refined by Webb et al. in 2006 through modification of the delivery system, and it remained as the predominant access route for transcatheter aortic valve implantation (TAVI) as of today [4]. ...
There is a growing trend for high‐risk patients with severe aortic stenosis who are denied open heart surgery to undergo transcatheter aortic valve implantation ( TAVI ). Since its invention more than two decades ago, TAVI has evolved rapidly from the proof‐of‐concept phase to become an established Food and Drug Administration‐approved technology. This article reviews the developmental histories and current status, as well as the future advancement of the technique.
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... Proof-of-concept for a catheter-mounted stent in humans came in 2000, when Bonhoeffer et al. implanted a platinum-iridium stent housing a bovine internal jugular vein conduit into the pulmonary artery of a boy with pulmonary atresia [4]. This was closely followed in 2002 by the first successful transcatheter aortic valve implantation (TAVI) for AS in a human via an anterograde transvenous approach using the historic Percutaneous Heart Valve™ (Percutaneous Heart Valves, Inc., NJ, USA), and the first retrograde transarterial approach was performed in 2003 [5]. ...
... It comprised a balloon-expandable stent with a bovine pericardium valve. This was housed in an 11Fr or 16Fr delivery catheter for transarterial delivery [5]. ...
The efficacy of transcatheter aortic valve implantation (TAVI) in high surgical risk and inoperable patients with severe aortic stenosis (AS) is rapidly gaining credibility with an ever-expanding body of supporting evidence. The potential of TAVI to be a treatment option for a significant cohort of patients with aortic stenosis has fuelled a drive for the optimum device and resulted in exponential advances in the technology with a focus on adverse event minimization and procedural simplification. Consequently, a plethora of new transcatheter valve choices are now available for clinical study or in the pipeline. The evaluation of past, current and emerging devices allows for an appreciation of the design considerations involved in this process and an insight to the future direction of the technology.
... This is, however, not required for the development of the theoretical and numerical methods described below, as they can be generalized to stents of arbitrary geometry with struts of different lengths. We have, in fact, used this ture of our numerical method to test the mechanical properties of a nonuniform stent designed for a transcatheter implantation of an aortic valve prosthesis [16, 17, 20]. The presentation of the methods, however, is much clearer if we assume throughout this paper that our stent has a uniform geometry. ...
We present a mathematical model for a study of the mechanical properties of endovascular stents in their expanded state. The model is based on the theory of slender curved rods. Stent struts are modeled as linearly elastic curved rods that satisfy the kinematic and dynamic contact conditions at the "vertices" where the struts meet. This defines a stent as a mesh of curved rods. A weak formulation for the stent problem is defined and a finite element method for a numerical computation of its solution was developed. Numerical simulations showing the pressure-displacement (axial and radial) relationship for the entire stent are presented. From the numerical data and from the energy of the problem we deduced an "effective" pressure-displacement relationship of the law of Laplace-type for the mechanical behavior of stents, where the proportionality constant in the Laplace law was expressed explicitly in terms of the geometric and mechanic properties of a stent.
... Tehnicile percutane au fost dezvoltate începând cu 1985, când Cribier a efectuat prima valvuloplastie aortică [19]. În 2000 a fost raportată primul stent valvular introdus percutan, iar în 2002 prima protezare aortică percutană [20][21][22][23]. ...
... Tehnica retrogradă, în care calea de acces este reprezentată de artera femurală, abordul valvei aortice fiind realizat retrograd. Prima protezare prin abord retrograd a fost raportată în 2005, de Paniagua D et al [23], de la Centrul de cardiologie din Caracas, la un bărbat de 62 ani, cu SAo calcificată severă şi multiple comorbidităţi (hipertensiune pulmonară severă, insuficienţă cardiacă congestivă, insuficienţă renală cronică), dar pacientul a decedat în a 5-a zi postoperator ca urmare a unei embolii pulmonare, deşi proteza valvulară funcţiona corespunzător din punct de vedere hemodinamic. ...
Degenerative aortic stenosis is one of the most frequent valvular disease. About 25% from the people over 65 years old had aortic sclerosis and about 4% from the inhabitants older then 75 years old had aortic stenosis. Aortic valve replacement (AVR) is the treatment of choice. The overall postoperative mortality of this operation is under 5% especially in large volume surgical centers. For the patients older then 80 years old and with severe comorbidities the postoperative mortality rate of AVR operation is over 15%. For this category of patients the best approach is AVR using a minimally invasive approach, especially the percutaneous approach. The paper describes the different tehniques and valvular prosthesis for minimally invasive AVR. The data from the literature - actual indications, valvular prosthetic types and results of different minimally invasive tehniques - are discussed.
... This is, however, not required for the development of the theoretical and numerical methods described below, as they can be generalized to stents of arbitrary geometry with struts of different lengths. We have, in fact, used this fea- ture of our numerical method to test the mechanical properties of a nonuniform stent designed for a transcatheter implantation of an aortic valve prosthesis [16,17,20]. The presentation of the methods, however, is much clearer if we assume throughout this paper that our stent has a uniform geometry. ...
We present a novel mathematical model to study the mechanical properties of endovascular stents in their expanded state. The model is based on the theory of slender curved rods. Stent struts are modeled as linearly elastic curved rods that satisfy the kinematic and dynamic contact conditions at the vertices where the struts meet. A weak for-mulation for the stent problem is defined and a Finite Element Method for a numerical computation of its solution is used to study mechani-cal properties of two commonly used coronary stents (Palmaz-like and Xience-like stent) in their expanded, fractured state. A simple fracture (separation), corresponding to one stent strut being disconnected from one vertex in a stent, was considered. Our results show a drastic differ-ence in the response of the two stents to the physiologically reasonable uniform compression and bending forces.
... There are several other aortic PHVs that have already done the first-in-man application, such as the Paniagua PHV of Endoluminal Technology Research (Miami, Florida) (Fig. 3) (29), the Enable PHV of ATS (Minneapolis, Minnesota) (3-F) (Fig. 4), the AorTx PHV of Hansen Medical (Mountain View, California) (Fig. 5), the Direct (Fig. 6), the Lotus PHV from Sadra Medical (Campbell, California) (Fig. 7), the Perceval PHV from Sorin Group (Arvada, Colorado) (Fig. 8), and the Jena PHV from JenaValve Technology (Wilmington, Delaware) ( Fig. 9) (Table 1). Furthermore, several other innovative devices are currently in the developmental stage or in pre-clinical testing (30,31). ...
Aortic valve stenosis is increasing in frequency as the population ages. Surgical aortic valve replacement is the gold standard for symptomatic patients with severe aortic valve stenosis. However, in a subset of high-risk patients, the surgical option is excluded due to severe comorbidities. Recently, an alternative to surgical aortic valve replacement--percutaneous aortic valve replacement (PAVR)--has emerged. Since the first PAVR in a human in 2002, the percutaneous heart valves (PHVs) have already undergone several modifications from first generation devices. Currently, there are 2 PHVs in clinical application, a balloon-expandable and a self-expandable PHV, with several others achieving first-in-man application. With the extremely rapid technological advancements, PAVR is probably here to stay. The next steps required would be to formulate goals to assess results and outcomes of PAVR, and plan trials to test their clinical applicability. This article discusses how best to assess results and outcomes, which may require a paradigm shift in mindset. Apart from the randomized controlled trial, some of the more novel concepts in trial design, which may be more suitable in this area, are also explored.
