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Cryopreserved aortic allograft with aortic arch

Cryopreserved aortic allograft with aortic arch

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Article
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The Ross operation is the operation of choice for children who require aortic valve replacement (AVR) and may also provide a good option in selected adult patients. Although the autograft does not require anticoagulation and has a superior haemodynamic profile, concern regarding autograft and allograft longevity has risen. In this light, we report...

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Context 1
... 15-year freedom from reoperation was 81.4%±6.2% ( Figure 3); for allograft patients 75.8%±9.0% and for mechanical prosthesis patients 92.9%±6.9% ...
Context 2
... The necessity for reoperation will increase for both valves in the second decade after operation and this increase seems larger for autograft patients. This trend is already to some extent seen in Figure 3 and is also reported in other series. [ easier to perform. ...
Context 3
... of death are described below by study center. 98.4% at 10 year for age-matched individuals in the general population and after homograft and mechanical prosthesis implantation 84.8% and 84.4%, respectively (see Figure 3). ...
Context 4
... died of multi-organ failure between the 6 th and 16 th day postoperative. Late death occurred in another 3 patients: two Figure 3. Cumulative survival after autograft aortic root replacement, survival of a 35-year-old male in the UK population, and microsimulation-based survival estimates of 35-year-old patient with a cryopreserved homograft or bileafl et mechanical prosthesis. ...
Context 5
... at 13 years 87.1%±5.5% (Figure 3). Freedom from allograft reoperation for structural failure did not differ for patients younger than 16 years compared to patients aged 16 years and older at the time of operation (80.0%±1.1% versus 92.5%±3.8% at 13 years (Log-rank test p=0.73)). ...

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Citations

... The Ross procedure is the only living aortic valve substitute available [13], translating to optimal hemodynamics, requiring no anticoagulation, and having excellent long-term outcomes in experienced hands [137,139]. However, it transforms single-valve disease to double-valve disease and is technically demanding [140]. The unique benefits and drawbacks of all substitutes become immediately clear, but it remains a challenge to implement this into the decision-making process. ...
Article
Full-text available
During the Renaissance, Leonardo Da Vinci was the first person to successfully detail the anatomy of the aortic root and its adjacent structures. Ever since, novel insights into morphology, function, and their interplay have accumulated, resulting in advanced knowledge on the complex functional characteristics of the aortic valve (AV) and root. This has shifted our vision from the AV as being a static structure towards that of a dynamic interconnected apparatus within the aortic root as a functional unit, exhibiting a complex interplay with adjacent structures via both humoral and mechanical stimuli. This paradigm shift has stimulated surgical treatment strategies of valvular disease that seek to recapitulate healthy AV function, whereby AV disease can no longer be seen as an isolated morphological pathology which needs to be replaced. As prostheses still cannot reproduce the complexity of human nature, treatment of diseased AVs, whether stenotic or insufficient, has tremendously evolved, with a similar shift towards treatments options that are more hemodynamically centered, such as the Ross procedure and valve-conserving surgery. Native AV and root components allow for an efficient Venturi effect over the valve to allow for optimal opening during the cardiac cycle, while also alleviating the left ventricle. Next to that, several receptors are present on native AV leaflets, enabling messenger pathways based on their interaction with blood and other shear-stress-related stimuli. Many of these physiological and hemodynamical processes are under-acknowledged but may hold important clues for innovative treatment strategies, or as potential novel targets for therapeutic agents that halt or reverse the process of valve degeneration. A structured overview of these pathways and their implications for cardiothoracic surgeons and cardiologists is lacking. As such, we provide an overview on embryology, hemodynamics, and messenger pathways of the healthy and diseased AV and its implications for clinical practice, by relating this knowledge to current treatment alternatives and clinical decision making.
... The Ross procedure is the only living aortic valve substitute available [13], translating to optimal hemodynamics, requiring no anticoagulation, and having excellent long-term outcomes in experienced hands [137,139]. However, it transforms single-valve disease to double-valve disease and is technically demanding [140]. The unique benefits and drawbacks of all substitutes become immediately clear, but it remains a challenge to implement this into the decision-making process. ...
Preprint
Full-text available
During the Renaissance, Leonardo Da Vinci was the first person to successfully detail the anatomy of the aortic root and its adjacent structures. Ever since, novel insights into morphology, function and their interplay have accumulated resulting in advanced knowledge on complex functional characteristics of the aortic valve (AV) and root. This shifted the vision from the AV as being a static structure towards that of a dynamic interconnected apparatus within the aortic root as a functional unit, exhibiting a complex interplay with adjacent structures via both humoral and mechanical stimuli. This paradigm shift has stimulated surgical treatment strategies of valvular disease that seek to recapitulate healthy AV function, whereby AV disease can no longer be seen as an isolated morphological pathology which needs to be replaced. As prostheses still cannot reproduce the complexity of human nature, treatment of diseased AVs, whether stenotic or insufficient, has tremendously evolved with a similar shift towards treatments options that are more hemodynamically centered such as the Ross procedure and valve-conserving surgery. Native AV and root components allow for an efficient Venturi effect over the valve to allow for optimal opening during the cardiac cycle, while also alleviating the left ventricle. Next to that, several receptors are present on native AV leaflets, enabling messenger pathways based on their interaction with blood and other shear-stress related stimuli. Many of these physiological and hemodynamical processes are under acknowledged but may hold important clues for innovative treatment strategies, or as potential novel targets for therapeutic agents that halt or reverse the process of valve degeneration. A structured overview of these pathways and their implications for cardiothoracic surgeons and cardiologists is lacking. As such, we provide an overview on embryology, hemodynamics, and messenger pathways of the healthy and diseased AV and its implications for clinical practice, by relating this knowledge to current treatment alternatives and clinical decision-making.
... A notable theme arises when analyzing the historical context and implementation outcomes of the Ross procedure, noting initial enthusiasm was later met with skepticism after publications of poor outcomes and complications led to concerns of feasibility, which in turn created hesitation to adopt Ross as a treatment option for adult aortic valvular heart disease [4,5]. A recent systematic review and meta-analysis sought to compare the Ross procedure with mechanical aortic valve replacement (mAVR) in adult patients, citing that the Ross procedure was found to have improved freedom from all-cause mortality and challenging decades of concerns over the perception that the Ross procedure imposes increased surgical risk and high rates of reintervention [6][7][8]. Thus, the dichotomy between recent data and existing guidelines again frames the question of what is the optimal aortic valve substitute in young and middle-aged adults requiring aortic valve surgery? The aim of this manuscript is to review the historical context of the Ross procedure, highlighting the past and current evidence, as well as to characterize the barriers to dissemination and implementation of Ross within current practice. ...
... The estimated peak of Ross procedures within North American was postulated to be circa 1998, when it accounted for approximately 1.2% of aortic valve replacements (AVR) and was then followed by a steady decline through 2010 [7]. During this era of decline, multiple studies conveyed concern regarding the efficacy of the Ross procedure and further contributed to the ongoing decline in implementation into clinical practice [8,15,16]. In 2014, Reece et al. performed a propensity-matched analysis from the STS database, publishing findings that the Ross procedure was Implementation process • Active change process • Aimed to achieve individual and organization use of an intervention associated with a 3-fold higher operative mortality comparted to conventional AVR (2.7% vs. 0.9%) [7]; however, Mazine and El-Hamamsy diligently note that the median annual number of Ross procedures performed per center was less than 1, and only 6 of the 231 centers analyzed had performed greater than or equal to 5 Ross procedures annually, raising concern for confounding given prior data on aortic root surgery volume and outcomes [17,18]. ...
Article
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Background The science of dissemination and implementation (D&I) aims to improve the quality and effectiveness of care by addressing the challenges of incorporating research and evidence-based practice into routine clinical practice. This lens of D&I has challenged the interpretation and incorporation of data, noting that failure of a given therapy may not reflect lack of efficacy, but instead reflect an imperfect implementation. The aim of this manuscript is to review the influence of the Ross procedure’s historical context on its D&I. Methods A contextual baseline of the Ross procedure was defined from the procedure’s original description in the literature to major publications since the 2017 valvular heart disease guidelines. D&I evaluation was conducted using the Consolidated Framework for Implementation Research (CFIR), using constructs from each of the five respective domains to define the main determinants. Results Each of the five CFIR domains appears to be correlated with a factor influencing the Ross procedure’s varied history of enthusiasm and acceptance. The complex nature of Ross required adaptation for optimization, with a strong correlation of center volume on outcomes that were not considered in non-contemporary studies. Outcomes later published from those studies influenced social and cultural contexts within the aortic surgery community, and led to further organizational uncertainty, resulting in slow guideline incorporation. Conclusions The D&I of the Ross procedure was a result of inadequate appreciation of technical complexity, effect of patient selection, and complex aortic surgery experience, resulting in dismissal of an efficacious procedure due to a misunderstanding of effectiveness.
... Despite this, Ross procedures have declined in the past two decades due to the technical complexity involved. In addition, the procedure relies on only one surgeon's expertise [9, 10], despite the increased surgical risk and rising rates of autograft failure requiring reintervention [11,12], Further, new surgical alternatives to mechanical, bioprosthetic, and autograft valves have been proposed, including homograft valves derived from deceased donors or the Ozaki procedure [13]. Aortic valve neocuspidization, or the Ozaki procedure, involves shaping the pericardium into an aortic valve contour, but its effectiveness is still debated compared to conventional substitutes [14]. ...
Article
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Background There has been a resurgence in interest regarding the Ross procedure due to recent publications detailing positive long-term outcomes. Conversely, surgical aortic valve replacement (SAVR) with a pulmonary homograft (PH), mechanical (MV), bioprosthetic (BV), or the Ozaki procedure each has its own technical advantages and disadvantages. Therefore, we performed a network meta-analysis (NMA) comparing other alternatives to Ross procedure. Methods Medical databases were comprehensively searched for studies comparing the Ross procedure with AVR using a PH, MV, BV, or the Ozaki procedure. Outcomes were pooled as risk ratios (RR) with their 95% confidence intervals (95% CI). Results A total of 7816 patients were pooled for our NMA from 24 studies. Compared to Ross procedure, both BV and MV were associated with significantly higher rates of 30-day mortality of RR (2.37, 95% CI 1.20–4.67) and (1.88 95% CI 1.04–3.40), respectively, with no significant difference regarding PH or Ozaki. However, only MV was associated with a higher risk of 30-day stroke (RR 8.42, 95% CI 1.57–45.23) with no significant difference in the other alternatives, as well as 30-day MI which showed no significant differences between any of the aortic conduits compared to the Ross procedure. Regarding 30-day major bleeding, MV was associated with a higher when compared to the Ross procedure RR (4.58, 95% CI 1.94–10.85), PH was associated with a lower risk of major bleeding with RR (0.35, 95% CI 0.17–0.71), and BV showed no significant difference. With a mean follow-up duration of 8.5 years compared to the Ross procedure, BV, PH, and MV were associated with a higher risk of long-term mortality with RR (1.89, 95% CI 1.38–2.58), (1.38, 95% CI 1.0–1.87), and (1.94, 95% CI 1.52–2.47), respectively, with the Ozaki procedure showed no significant difference. Regarding long-term stroke—with a mean of 6.3-year follow-up duration—there were no significant differences between any of the aortic conduits compared to the Ross procedure. Nevertheless, long-term need for reintervention—with a mean follow-up duration of 17.5 years—was significant of higher risk with both BV and PH with RR (3.28, 95% CI 1.21–8.84) and (2.42, 95% CI 1.05–5.58), respectively, compared to Ross procedure with MV and Ozaki having no significant difference. Conclusions The Ross procedure is a viable treatment option for patients undergoing SAVR, showing promising outcomes at short- and long-term follow-ups.
... Despite this, Ross procedures have declined in the past two decades due to the technical complexity involved. In addition, the procedure relies on only one surgeon's expertise [9, 10], despite the increased surgical risk and rising rates of autograft failure requiring reintervention [11,12], Further, new surgical alternatives to mechanical, bioprosthetic, and autograft valves have been proposed, including homograft valves derived from deceased donors or the Ozaki procedure [13]. Aortic valve neocuspidization, or the Ozaki procedure, involves shaping the pericardium into an aortic valve contour, but its effectiveness is still debated compared to conventional substitutes [14]. ...
... Creating a two-valve problem has long been perceived as the weakness of the Ross procedure. By 2010, the Ross procedure accounted for only <0.1% of all aortic valve replacements performed [37,38]. One of the most important factors driving this regression was the complexity of the procedure; despite adjustments to simplify it, it remains challenging and perioperative mortality in lowvolume centers is non-negligible [37,39,40]. ...
... One of the most important factors driving this regression was the complexity of the procedure; despite adjustments to simplify it, it remains challenging and perioperative mortality in lowvolume centers is non-negligible [37,39,40]. Studies also reported that the potential failure of two valves exposes patients to complex reoperations [38,41,42]. ...
... Several centers worldwide however continued to perform the operation as a complex alternative for conventional valve replacements. Long-term results and adaptation processes were closely Concerns remain regarding late autograft dilatation, particularly in patients with preoperative aortic regurgitation [38,57]. Almost all failed autograft replacements will have had regurgitation as the initial pathology [58]. ...
Thesis
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Background: The Ross procedure uses a patient’s own pulmonary valve to replace the diseased aortic valve. It is an alternative to conventional valve replacement especially in the younger patient population. This patient group, and patients with contraindications against conventional valve re- p lacements, may benefit from a Ross procedure if it can be performed safely and with adequate durability. The aim of this study was to assess the reproducibility, survival, and durability of pulmo- nary autograft replacements in our institution. Methods: Bet ween December 1995 and December 2020, 202 patients (male 73%; mean age 35.4±11.4 years) underwent the Ross procedure at our institution. Eight patients were lost to follow up and were excluded from the long term analysis. One patient was intraoperatively c onverted to a Bentall procedure. Five patients underwent a cylinder Ross procedure and 196 patients a full root replacement. Aortic v alve morphology was unicuspid in 87 ( bicuspid in 76 ( and tricus- pid in 25 ( patients. Fourteen patients had undergone valve replacement previously, and the morphology could not be determined. Results: Overall, 202 patients were analyzed, 10 patients died, and 8 patients were lost to follow up. The pulmonary valve was replaced with a ho mograft in 156 patients, with a bovine jugular vein graft in 35 patients, and in 10 patients with a stentless bio logical valve prosthesis Mean myocardial ischemia time was 91±20minutes; mean perfusion time was 125±33 minutes. Fifty eight patients required a concomitant procedure during their Ross operation, most commonly as- cending aortic replacement (n= There was one perioperative death, no myocardial infarction, and one neurological complication. A permanent pacemaker was implanted in four cases ( There was one late deat h from a non cardiac cause. Twenty three patients required reinterventions after the Ross procedure (pulmonary autograft n=16, pulmonary conduit n= 7). A valve sparing pro- cedure was performed in the majority of cases. At 10 years, survival was 93%, simila r to that of the age and gender matched German population. Freedom from autograft reintervention at 10 years was 89% and freedom from RV PA reintervention was 93%. Median and mean follow up were 5.7 [range 0.1 24.4] years and 7.8 ±7 years. Clinical and echocardiography follow up were 95% and 92% complete (1467 patient years). Conclusion The Ross procedure represents a safe and valid option in young and middle aged patients. It is associated with low perioperative morbidity and mortality. The probabilit y of reinterven- tions is low and long term survival is excellent, similar to that of the age and gender matched general German population.
... In the best hands, dilation of the free-standing autograft will result in a failure rate of around 25% of these valves within 20 years. 5,6 Following the pioneering work of Skillington, it became clear that Authors have nothing to disclose concerning commercial support. *Division of Cardiac Surgery, Children's National Hospital, The George ...
Article
The Ross procedure is superior as a valve substitute in children and early adulthood because of its clear survival benefits. The free standing-root implantation is associated with failure of the autograft and inclusion techniques that support externally the autograft warrants its longevity. The current technique consists in the implantation of the autograft within the native aortic root thereby both supporting the autograft and avoiding any coronary distortion.
... The major drawback to the Ross procedures is the possible need of reoperation due to potential failure of both the autograft and/or the pulmonary homograft. This is often referred to the "Achilles' heel" of the Ross procedure [24]. This could be one of a few reasons why the Ross procedure is not included as a first-line Class Ia recommendation in cardiology and cardiac surgery societal guidelines on AV replacement [25,26]. ...
... This could be one of a few reasons why the Ross procedure is not included as a first-line Class Ia recommendation in cardiology and cardiac surgery societal guidelines on AV replacement [25,26]. Older reports found that after 13 years of follow-up, freedom from autograft and homograft reoperation was 57% and 93% respectively [24]. Of note, when compared to other AVR options, studies have shown that the Ross has superior long-term freedom from valverelated mortality and all-cause mortality compared to mechanical valves (97% vs. 89%) [27,28]. ...
Chapter
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Congenital aortic valve stenosis represents 3–5% of patients with congenital heart disease. Management options include both transcatheter and surgical. Open valvotomy/valvuloplasty and aortic valve replacement represent the main surgical choices, and while aortic valve repair is preferred, replacement may be the only option for non-repairable valves. Current available replacement options include pulmonary autograft, homografts, and biological or mechanical prostheses. The Ross procedure first introduced in 1967 by Donald Ross utilizes the patient’s pulmonary valve (autograft) as an aortic valve substitute. Despite being technically challenging it carries the advantages of maintaining the growth potentials and freedom from anticoagulation which are important in young patients. The procedure gained wide interest initially, however it fell out of favor due to concerns related to its complexity and risks of creating “two-valve” disease. Recently, long-term data confirmed the Ross procedure excellent outcomes and better survival in comparison to other aortic valve replacement options. As a result, currently it is considered the procedure of choice for young adults with congenital aortic valve stenosis at many institutions. This chapter discusses the technical aspects of the Ross procedure, and its modifications, and available options for the failing Ross, in addition to outcomes and future directions.
... Nevertheless, advancements in surgical techniques and perioperative care as well as standardization of the procedure in expert centres have led to a significant improvement in results [3][4][5][6][7]. According to the available evidence, the Ross procedure is currently the only surgical replacement modality for the treatment of aortic valve disease offering a long-term survival comparable with that of the general population [3,[8][9][10]. The population of young and middle-aged adults could therefore benefit from this strategy the most. ...
... The Ross procedure is the only surgical replacement modality that may offer these patients survival comparable to that of the general age-and sex-matched population [3,8,10,19]. However, mAVR remains the standard of care in many centres in this patient group because of the complexity of the operation and the inherent risk of reoperation in the long term after the Ross procedure [2,9]. Two recent meta-analyses have compared these 2 competing strategies, both of which support the longterm benefit of the Ross procedure [6,7]. ...
Article
OBJECTIVES The choice of optimal surgical treatment for young and middle-aged adults with aortic valve disease remains a challenge. Mechanical aortic valve replacement (mAVR) is generally preferred despite promising recent outcomes of the Ross procedure. Our goal was to compare the strategies at a nationwide level. METHODS This study was a retrospective analysis of prospectively recorded data from the National Registry of Cardiac Surgery of the Czech Republic. Using propensity score matching, we compared the outcomes of patients undergoing the Ross procedure in 2 dedicated centres with all mAVRs performed in country between 2009 and 2020. RESULTS Throughout the study period, 296 adults underwent the Ross procedure and 5120 had an mAVR. We found and compared 291 matched pairs. There were no in-hospital deaths, and the risk of perioperative complications was similar in both groups. Over the average follow-up period of 4.1 vs 6.1 years, the Ross group had a lower all-cause mortality (0.7 vs 6.5%; P = 0.015). This result remained significant even when accounting for cardiac- and valve-related deaths only (P = 0.048). Unlike the Ross group, the mAVR group had a significantly lower relative survival compared with the age- and sex-matched general population. There was no difference in the risk of reoperation (4.5 vs 5.5%; P = 0.66). CONCLUSIONS The Ross procedure offers a significant midterm survival benefit over mAVR. The procedures have a comparable risk of perioperative complications. Patients after mAVR have reduced survival. Thus, the Ross procedure should be the preferred treatment option for young and middle-aged adults with aortic valve disease in dedicated centres.
... 5 The main concern with root replacement is the vulnerability to progressive dilatation of the PA with or without aortic valve incompetence, with reported incidence of freedom from reoperations varying from 69% to 93% at 15 years. 5,6 To avoid dilatation, some have advocated external reinforcement of the PA with polyethylene terephthalate grafts, polytetrafluoroethylene, or bovine pericardium. 3 The insertion of the PA inside a rigid synthetic graft may distort the normal geometry, restricting sinus expansion and autograft distensibility, which may influence the normal leaflet opening-and-closing mechanism, coronary flow reserve, and left ventricular impedance. ...