How to treat severe symptomatic structural valve deterioration of aortic surgical bioprosthesis: transcatheter valve-in-valve implantation or redo valve surgery?

How to treat severe symptomatic structural valve deterioration of aortic surgical bioprosthesis:... Abstract The optimal management of aortic surgical bioprosthesis presenting with severe symptomatic structural valve deterioration is currently a matter of debate. Over the past 20 years, the number of implanted bioprostheses worldwide has been rapidly increasing at the expense of mechanical prostheses. A large proportion of patients, however, will require intervention for bioprosthesis structural valve deterioration. Current options for older patients who often have severe comorbidities include either transcatheter valve-in-valve (TVIV) implantation or redo valve surgery. The emergence of TVIV implantation, which is perceived to be less invasive than redo valve surgery, offers an effective alternative to surgery for these patients with proven safety and efficacy in high-risk patient groups including elderly and frail patients. A potential caveat to this strategy is that results of long-term follow-up after TVIV implantation are limited. Redo surgery is sometimes preferable, especially for young patients with a smaller-sized aortic bioprosthesis. With the emergence of TVIV implantation and the long experience of redo valve surgery, we currently have 2 complementary treatment modalities, allowing a tailor-made and patient-orientated intervention. In the heart team, the decision-making should be based on several factors including type of bioprosthesis failure, age, comorbidities, operative risk, anatomical factors, anticipated risks and benefits of each alternative, patient’s choice and local experience. The aim of this review is to provide a framework for individualized optimal treatment strategies in patients with failed aortic surgical bioprosthesis. Valve-in-valve , Transcatheter valve implantation , Bioprosthesis , Redo valve surgery , Structural valve deterioration INTRODUCTION Over the past 20 years, the number of implanted bioprostheses worldwide has been increasing rapidly at the expense of mechanical prostheses [1], with a marked acceleration since the implementation of transcatheter aortic valve replacement (TAVR) procedures [2]. In 2016, 89% of all aortic prostheses surgically implanted in Germany were bioprostheses [3]. This trend is particularly marked in younger patients. Several factors may explain the substantial increase in the number of implanted bioprostheses: the decrease in the incidence of rheumatic valvulopathy in the West, the current predominance of degenerative valvulopathies in older patients, the extended durability of some bioprostheses and, in particular, the availability of transcatheter valve-in-valve (TVIV) implantation in case of structural deterioration. Indeed, the main disadvantage of bioprosthesis is the risk of structural valve deterioration (SVD) in the short term or medium term with the need for repeat surgery, in patients who are older and more fragile. The emergence of TVIV procedures, perceived as less invasive than redo valve surgery for an elderly patient, offers an effective alternative for these patients and has influenced the decision to choose a bioprosthesis over mechanical prostheses, particularly in middle-aged patients [4]. Compared to mechanical prosthesis, the strategy to implant aortic bioprosthesis at the first operation and to perform TVIV implantation in case of SVD allows to avoid the mandatory lifelong vitamin K antagonist therapy. Indeed, long-term anticoagulant therapy can be difficult to maintain in elderly patients due to the bleeding complications and frailty of these patients [5]. Literature search This review was designed by drawing information from a study of Stroup et al. [6]. We started on 1 November 2017 and launched searches on Pub Med, EMBASE and CINAHL using the following search terms: aortic valve replacement and redo surgery, aortic valve replacement and SVD, TVIV—degenerated (or failed) bioprosthetic aortic valve and TVIV versus redo aortic valve surgery. We assessed a large number of publications from 2001 to 2017 in humans who were scheduled for aortic valve redo surgery and those who were treated by redo surgical aortic valve replacement (SAVR) or TVIV implantation. In addition, we searched the Cochrane library by entering the following key words: ‘degenerated bioprosthetic aortic valve’ or ‘redo aortic valve surgery’ or ‘TVIV’ to access titles and abstracts for detailed analysis of the manuscript. The literature has been screened by 2 reviewers (D.A. and F.N.) who analysed the titles and abstracts of all selected studies. Inclusion criteria included completeness and high quality of follow-up >90% and studies with a cohort size ranging from 45 [7] to 3380 patients [8], reflecting the level of centre experience. The target criteria of study included indication for aortic redo surgery due to SVD, mortality and/or morbidity after TVIV or SVAR procedure that were evaluated in patients with prior aortic valve replacement with stented xenograft prosthesis. Particular attention was given to randomized controlled trials and register studies that reported on a large number of patients. When authors addressed multiple publications related to the same patient population, the most recent report was selected. In cases of disagreement, the analysis for review collection data was stopped until an agreement was found. The list of publications overview is reported in Tables 1–3. Table 1: Publications overview: aortic TVIV implantation Authors Year of publication Time span Number of patients Mean age (years) 30-Day mortality (%) 1-Year mortality (%) Eggebrecht et al. [7] 2011 2005–2010 47 80.3 17 NA Dvir et al. [9] 2012 2010–2012 202 77.7 8.4 14.2 Ihlberg et al. [10] 2013 2008–2012 45 80.6 4.4 11.9 Dvir et al. [11] 2014 2007–2013 459 77.6 7.6 16.8 Webb et al. [12] 2017 2011–2016 365 78.9 2.7 12.4 Authors Year of publication Time span Number of patients Mean age (years) 30-Day mortality (%) 1-Year mortality (%) Eggebrecht et al. [7] 2011 2005–2010 47 80.3 17 NA Dvir et al. [9] 2012 2010–2012 202 77.7 8.4 14.2 Ihlberg et al. [10] 2013 2008–2012 45 80.6 4.4 11.9 Dvir et al. [11] 2014 2007–2013 459 77.6 7.6 16.8 Webb et al. [12] 2017 2011–2016 365 78.9 2.7 12.4 NA: not available; NS: no significant; TVIV: transcatheter valve-in-valve. Table 1: Publications overview: aortic TVIV implantation Authors Year of publication Time span Number of patients Mean age (years) 30-Day mortality (%) 1-Year mortality (%) Eggebrecht et al. [7] 2011 2005–2010 47 80.3 17 NA Dvir et al. [9] 2012 2010–2012 202 77.7 8.4 14.2 Ihlberg et al. [10] 2013 2008–2012 45 80.6 4.4 11.9 Dvir et al. [11] 2014 2007–2013 459 77.6 7.6 16.8 Webb et al. [12] 2017 2011–2016 365 78.9 2.7 12.4 Authors Year of publication Time span Number of patients Mean age (years) 30-Day mortality (%) 1-Year mortality (%) Eggebrecht et al. [7] 2011 2005–2010 47 80.3 17 NA Dvir et al. [9] 2012 2010–2012 202 77.7 8.4 14.2 Ihlberg et al. [10] 2013 2008–2012 45 80.6 4.4 11.9 Dvir et al. [11] 2014 2007–2013 459 77.6 7.6 16.8 Webb et al. [12] 2017 2011–2016 365 78.9 2.7 12.4 NA: not available; NS: no significant; TVIV: transcatheter valve-in-valve. Table 2: Publication overview: redo SAVR (with SAVR as first cardiac surgery) Authors Year of publication Time span Number of patients Mean age (years) Proportion of patients non-eligible for TVIVa (%) Proportion of SVD (%) 30-Day mortality (%) Jones et al. [13] 2001 1969–1998 187 54.7 NA NA 6.4 Jamieson et al. [14] 2003 1975–1999 322 NA 0% 100% 6.8 Potter et al. [15] 2005 1993–2001 162 64 56.5 (13% IE) 43.5% 5 Eitz et al. [16] 2006 1991–2004 71 All ≥80 years 23.9 (11.3% IE) 76.1% 16.4 Davierwala et al. [17] 2006 1990–2002 216 59 10 (7.9% IE) NA 4.6 Leontyev et al. [18] 2011 1994–2008 155 58.1 45.2 (27.1% IE) 23.8% 3.5 Chan et al. [19] 2012 1971–2008 437 58.6 NA NA 6 Ruggieri et al. [20] 2013 1975–2011 164 67.8 42.7% 57.3% 10.6 Onorati et al. [21] 2015 2003–2013 324 31.2% >75 years 33% IE 55.2% 7.7 Kaneko et al. [8] 2015 2011–2013 3380 66 13.1% IE NA 4.6 Naji et al. [22] 2015 2000–2012 276 (stenotic bioprosthesis) 64 5% IE 0.5% thrombosis 95% (47% with size ≤21 mm) 2.5 Authors Year of publication Time span Number of patients Mean age (years) Proportion of patients non-eligible for TVIVa (%) Proportion of SVD (%) 30-Day mortality (%) Jones et al. [13] 2001 1969–1998 187 54.7 NA NA 6.4 Jamieson et al. [14] 2003 1975–1999 322 NA 0% 100% 6.8 Potter et al. [15] 2005 1993–2001 162 64 56.5 (13% IE) 43.5% 5 Eitz et al. [16] 2006 1991–2004 71 All ≥80 years 23.9 (11.3% IE) 76.1% 16.4 Davierwala et al. [17] 2006 1990–2002 216 59 10 (7.9% IE) NA 4.6 Leontyev et al. [18] 2011 1994–2008 155 58.1 45.2 (27.1% IE) 23.8% 3.5 Chan et al. [19] 2012 1971–2008 437 58.6 NA NA 6 Ruggieri et al. [20] 2013 1975–2011 164 67.8 42.7% 57.3% 10.6 Onorati et al. [21] 2015 2003–2013 324 31.2% >75 years 33% IE 55.2% 7.7 Kaneko et al. [8] 2015 2011–2013 3380 66 13.1% IE NA 4.6 Naji et al. [22] 2015 2000–2012 276 (stenotic bioprosthesis) 64 5% IE 0.5% thrombosis 95% (47% with size ≤21 mm) 2.5 a IE, paraprosthetic leaks, thrombosis. IE: infective endocarditis; SAVR: surgical aortic valve replacement; SVD: structural valve deterioration; TVIV: transcatheter valve-in-valve. Table 2: Publication overview: redo SAVR (with SAVR as first cardiac surgery) Authors Year of publication Time span Number of patients Mean age (years) Proportion of patients non-eligible for TVIVa (%) Proportion of SVD (%) 30-Day mortality (%) Jones et al. [13] 2001 1969–1998 187 54.7 NA NA 6.4 Jamieson et al. [14] 2003 1975–1999 322 NA 0% 100% 6.8 Potter et al. [15] 2005 1993–2001 162 64 56.5 (13% IE) 43.5% 5 Eitz et al. [16] 2006 1991–2004 71 All ≥80 years 23.9 (11.3% IE) 76.1% 16.4 Davierwala et al. [17] 2006 1990–2002 216 59 10 (7.9% IE) NA 4.6 Leontyev et al. [18] 2011 1994–2008 155 58.1 45.2 (27.1% IE) 23.8% 3.5 Chan et al. [19] 2012 1971–2008 437 58.6 NA NA 6 Ruggieri et al. [20] 2013 1975–2011 164 67.8 42.7% 57.3% 10.6 Onorati et al. [21] 2015 2003–2013 324 31.2% >75 years 33% IE 55.2% 7.7 Kaneko et al. [8] 2015 2011–2013 3380 66 13.1% IE NA 4.6 Naji et al. [22] 2015 2000–2012 276 (stenotic bioprosthesis) 64 5% IE 0.5% thrombosis 95% (47% with size ≤21 mm) 2.5 Authors Year of publication Time span Number of patients Mean age (years) Proportion of patients non-eligible for TVIVa (%) Proportion of SVD (%) 30-Day mortality (%) Jones et al. [13] 2001 1969–1998 187 54.7 NA NA 6.4 Jamieson et al. [14] 2003 1975–1999 322 NA 0% 100% 6.8 Potter et al. [15] 2005 1993–2001 162 64 56.5 (13% IE) 43.5% 5 Eitz et al. [16] 2006 1991–2004 71 All ≥80 years 23.9 (11.3% IE) 76.1% 16.4 Davierwala et al. [17] 2006 1990–2002 216 59 10 (7.9% IE) NA 4.6 Leontyev et al. [18] 2011 1994–2008 155 58.1 45.2 (27.1% IE) 23.8% 3.5 Chan et al. [19] 2012 1971–2008 437 58.6 NA NA 6 Ruggieri et al. [20] 2013 1975–2011 164 67.8 42.7% 57.3% 10.6 Onorati et al. [21] 2015 2003–2013 324 31.2% >75 years 33% IE 55.2% 7.7 Kaneko et al. [8] 2015 2011–2013 3380 66 13.1% IE NA 4.6 Naji et al. [22] 2015 2000–2012 276 (stenotic bioprosthesis) 64 5% IE 0.5% thrombosis 95% (47% with size ≤21 mm) 2.5 a IE, paraprosthetic leaks, thrombosis. IE: infective endocarditis; SAVR: surgical aortic valve replacement; SVD: structural valve deterioration; TVIV: transcatheter valve-in-valve. Table 3: Publication overview: TVIV implantation versus rAVR Authors Year of publication Time span Number of patients (TVIV vs rAVR) Mean age (years) Post-procedure mean gradient (mmHg) (TVIV vs rAVR) 30-Day mortality (%) (TVIV vs rAVR) Erlebach et al. [23] 2015 2001–2014 50 TVIV vs 52 rAVR TVIV 78.1 18.8 ± 8.7 vs 13.8 ± 5.4, P = 0.008 4% vs 0%, P = 0.24 rAVR 66.2 Silaschi et al. [24] 2016 2002–2015 71 TVIV vs 59 rAVR TVIV 78.6 19.7 ± 7.7 vs 12.2 ± 5.7, P < 0.01 4.2% vs 5.1%, P = 1 rAVR 72.9 Gozdek et al. [25] 2017 NA 176 TVIV vs 166 rAVR TVIV 75.3 No significant difference 5.4% vs 4.6%, P = NS rAVR 69 Spaziano et al. [26] 2017 2007–2015 78 TVIV vs 78 rAVR TVIV 77.4 18.1 ± 7.4 vs 14.3 ± 6.2, P = 0.01 3.9% vs 6.4%, P = 0.49 rAVR 78 Authors Year of publication Time span Number of patients (TVIV vs rAVR) Mean age (years) Post-procedure mean gradient (mmHg) (TVIV vs rAVR) 30-Day mortality (%) (TVIV vs rAVR) Erlebach et al. [23] 2015 2001–2014 50 TVIV vs 52 rAVR TVIV 78.1 18.8 ± 8.7 vs 13.8 ± 5.4, P = 0.008 4% vs 0%, P = 0.24 rAVR 66.2 Silaschi et al. [24] 2016 2002–2015 71 TVIV vs 59 rAVR TVIV 78.6 19.7 ± 7.7 vs 12.2 ± 5.7, P < 0.01 4.2% vs 5.1%, P = 1 rAVR 72.9 Gozdek et al. [25] 2017 NA 176 TVIV vs 166 rAVR TVIV 75.3 No significant difference 5.4% vs 4.6%, P = NS rAVR 69 Spaziano et al. [26] 2017 2007–2015 78 TVIV vs 78 rAVR TVIV 77.4 18.1 ± 7.4 vs 14.3 ± 6.2, P = 0.01 3.9% vs 6.4%, P = 0.49 rAVR 78 rAVR: redo aortic valve replacement; TVIV: transcatheter valve-in-valve. Table 3: Publication overview: TVIV implantation versus rAVR Authors Year of publication Time span Number of patients (TVIV vs rAVR) Mean age (years) Post-procedure mean gradient (mmHg) (TVIV vs rAVR) 30-Day mortality (%) (TVIV vs rAVR) Erlebach et al. [23] 2015 2001–2014 50 TVIV vs 52 rAVR TVIV 78.1 18.8 ± 8.7 vs 13.8 ± 5.4, P = 0.008 4% vs 0%, P = 0.24 rAVR 66.2 Silaschi et al. [24] 2016 2002–2015 71 TVIV vs 59 rAVR TVIV 78.6 19.7 ± 7.7 vs 12.2 ± 5.7, P < 0.01 4.2% vs 5.1%, P = 1 rAVR 72.9 Gozdek et al. [25] 2017 NA 176 TVIV vs 166 rAVR TVIV 75.3 No significant difference 5.4% vs 4.6%, P = NS rAVR 69 Spaziano et al. [26] 2017 2007–2015 78 TVIV vs 78 rAVR TVIV 77.4 18.1 ± 7.4 vs 14.3 ± 6.2, P = 0.01 3.9% vs 6.4%, P = 0.49 rAVR 78 Authors Year of publication Time span Number of patients (TVIV vs rAVR) Mean age (years) Post-procedure mean gradient (mmHg) (TVIV vs rAVR) 30-Day mortality (%) (TVIV vs rAVR) Erlebach et al. [23] 2015 2001–2014 50 TVIV vs 52 rAVR TVIV 78.1 18.8 ± 8.7 vs 13.8 ± 5.4, P = 0.008 4% vs 0%, P = 0.24 rAVR 66.2 Silaschi et al. [24] 2016 2002–2015 71 TVIV vs 59 rAVR TVIV 78.6 19.7 ± 7.7 vs 12.2 ± 5.7, P < 0.01 4.2% vs 5.1%, P = 1 rAVR 72.9 Gozdek et al. [25] 2017 NA 176 TVIV vs 166 rAVR TVIV 75.3 No significant difference 5.4% vs 4.6%, P = NS rAVR 69 Spaziano et al. [26] 2017 2007–2015 78 TVIV vs 78 rAVR TVIV 77.4 18.1 ± 7.4 vs 14.3 ± 6.2, P = 0.01 3.9% vs 6.4%, P = 0.49 rAVR 78 rAVR: redo aortic valve replacement; TVIV: transcatheter valve-in-valve. RESULTS Structural valve deterioration of bioprostheses The main disadvantage of bioprostheses is the risk of SVD leading to intraprosthetic regurgitation, stenosis or both (mixed type). Indeed, morphological SVD may be associated to severe haemodynamic changes [27, 28]. For aortic bioprosthesis, severe regurgitation-type SVD [defined by regurgitant orifice area >0.30 cm2 or vena contracta >6 mm or new or worsening (>2+/4+) from baseline] is usually caused by wear and tear or flail of the cusps, whereas severe stenosis-type SVD (mean transprosthetic gradient ≥ 40 mmHg or mean transprosthetic gradient ≥ 20 mmHg change from baseline) may be linked to fibrosis, calcification or pannus deposition (Fig. 1) [27, 29]. Therefore, redo valve surgery may be necessary to address SVD of a bioprosthetic valve, alongside other aetiologies of bioprosthesis dysfunction, such as endocarditis or paraprosthetic leak. Figure 1: View largeDownload slide Explanted aortic bioprosthesis for stenosis-type structural valve deterioration. Presence of severe calcification of the leaflets. Figure 1: View largeDownload slide Explanted aortic bioprosthesis for stenosis-type structural valve deterioration. Presence of severe calcification of the leaflets. Bourguignon et al. [30] published the results of a long-term follow-up conducted on 2659 patients 20 years after the implantation of Carpentier-Edwards Perimount aortic pericardial bioprostheses (Edwards Lifesciences, Irvine, CA, USA). In patients aged ≤60 years, freedom from reoperation due to SVD at 15 years was 70.8% ± 4.1%, with a low mortality rate (2.3%) for reoperation, when needed. The expected valve durability was 17.6 years for patients aged ≤60 years compared to 19.7 years for the entire cohort [30, 31]. However, not all bioprosthetic surgical valves have the same durability [32, 33]. In fact, Senage et al. [34] have reported a risk of rapid SVD for the Mitroflow bioprosthesis valve (Sorin Group Inc.), especially in small-calibre bioprosthesis (19–21 mm), where it significantly impacted the 5-year mortality rate. This predilection for early SVD has been recently confirmed by other reports, especially for smaller bioprostheses [35, 36]. Redo aortic valve replacement In elderly patients with comorbidities, redo aortic valve surgery may confer a higher risk of mortality than the initial surgery [13, 37]. However, the risk of death depends mainly on the comorbidities and the reasons for redo SAVR. Thus, it is important to emphasize that the risk of mortality is much higher for redo SAVR related to infective endocarditis (IE) or periprosthetic leaks than for SVD [13, 38]. In series reporting patients with IE undergoing redo SAVR, the operative mortality may exceed 10% [16, 20]. Other main risk factors of mortality include preoperative left ventricular ejection fraction (LVEF) <30%, preoperative New York Heart Association (NYHA) class III–IV, age >75 years, renal failure or concomitant chronic obstructive pulmonary disease [21, 39]. In Europe, an international multicentre registry reported that the rate of in-hospital mortality after repeat SAVR (i.e. reintervention on aortic valve prosthesis for failure or endocarditis of a previous AVR) was 7.7% [21]. When considering redo SAVR for SVD of a previous AVR, Jamieson et al. [14] have reported a similar operative mortality at 6.8% in a series of 322 patients in a period between 1975 and 1999. However, the operative mortality has decreased during recent years and now approaches that of the primary surgery. Thus, Naji et al. [22] have recently reported excellent outcomes for patients with severe stenotic bioprostheses undergoing redo SAVR with a 30-day mortality at 2.5%. In elderly patients, Onorati et al. [40] recently reported similar immediate postoperative outcomes for octogenarians and younger patients, with an in-hospital mortality rate of 3% and a 5-year survival rate of 83%. Although the mortality rate is acceptable, there is significant morbidity involved, such as haemodynamic instability, acute renal failure and prolonged intubation. There are also longer periods of aortic clamping and extracorporeal circulation, and a higher risk of bleeding and transfusions [21]. Redo surgery is associated with a higher risk of scar tissue, adhesions and iatrogenic effects on adjacent structures, with higher risk of post-operative pacemaker. Finally, a major surgical risk is vascular injury during dissection, causing damage to the bypass graft(s) during redo sternotomy. This life-threatening complication may be prevented by a preoperative computed tomography (CT) scan to visualize the relationship between the mediastinal contents and the sternum, and to identify the patients at risk of injury during re-entry. Aortic transcatheter valve-in-valve implantation Over the past decade, TAVR has become the treatment of choice for patients with prohibitive surgical risk and a safe and less invasive alternative to surgery in both high- and intermediate-risk patients with severe symptomatic native aortic stenosis [41–43]. Important breakthroughs were made regarding TVIV implantation using trans-femoral and apical approaches after a few isolated cases were reported [7, 9]. The safety and efficacy of this innovative and less-invasive approach were demonstrated in a high-risk population including elderly and frail patients [9]. One of the largest studies of aortic TVIV therapy is the international multicentre prospective Global Valve-in-Valve Registry [9, 11], which included 459 high-risk patients (mean age 77 years) who underwent aortic TVIV implantation: 40% for stenosis-type degeneration, 30% for regurgitation-type degeneration and 30% for mixed degeneration. On average, the procedure took place 9 years after the first aortic valve surgery (earlier in stenosis-type degeneration compared to regurgitation-type degeneration). Small-calibre bioprosthesis ≤ 21 mm) tended to degenerate more often towards stenosis than large-calibre bioprosthesis (≥ 25 mm), which tended to degenerate towards regurgitation. Mortality rates were 7.6% after 30 days and 16.8% after 1 year. After TVIV implantation, the mean valve-in-valve gradient was significantly higher in stenosis-type degeneration than in regurgitation-type degeneration (18 mmHg vs 12 mmHg, P < 0.001). Multivariate analysis indicated that the main risk factors of all-cause mortality for TVIV implantation were stenosis-type degeneration, small-calibre bioprosthesis surgical valve (≤21 mm), transapical approach for the procedure and a high Society of Thoracic Surgeons (STS) score [11]. Webb et al. [12] have also recently reported excellent outcomes for 365 high-risk patients (mean age 78.9 ± 10.2 years, mean STS score 9.1 ± 4.7%) with a very low 30-day mortality at 2.7% and a 1-year mortality at 12.4%, with an important effect on the procedural learning curve. However, long-term follow-up data are not available. In these publications, the causes of death were not reported, but the residual mean gradient after TVIV implantation was probably a major factor. Thus, Webb et al. [12] have shown that elevated transvalvular gradients (≥20 mmHg) after TVIV implantation was correlated to an increased 1-year mortality. Eggebrecht et al. [7] also reported a high proportion of patients (44%) with elevated transvalvular gradients (≥20 mmHg) after TVIV implantation, especially for those with degenerated surgical bioprostheses of small diameters. The smaller the degenerated bioprosthesis is, the higher the risk of an increase in mean gradient after TVIV implantation exists, because the TVIV prosthesis is inserted inside a non-elastic stent of the surgical bioprosthesis, thus predisposing to underexpansion of the TVIV prosthesis and leading to a smaller effective orifice area than when it is more fully expanded in a native aortic annulus [44]. Furthermore, Pibarot et al. [45] recently published a study indicating that pre-existing severe patient–prosthesis mismatch (more frequent with smaller bioprosthetic valves) was associated with a higher prevalence of elevated transaortic gradient after TVIV implantation and with 2.4- and 1.8-fold higher rates of 30-day mortality and 1-year mortality, respectively. Stenosis-type bioprosthesis degeneration increases the risk of mortality, potentially due to pressure-overload-induced remodelling and concentric left ventricular hypertrophy, which may result in heart failure with preserved LVEF, worsened by an elevated mean gradient after TVIV implantation. Many questions persist regarding outcomes of patients who have benefited from TVIV implantation: the longevity of the valve-in-valve bioprosthesis, the potential risk of rapid SVD especially with smaller bioprosthesis and the risks of bioprosthetic valve thrombosis. Compared to the wealth of knowledge on aortic surgical bioprosthesis longevity, there is indeed very scarce data concerning mid-term outcomes of patients treated using percutaneous approach: 5 years in TAVR [46, 47] and 1 year for TVIV implantation [11, 12]. Therefore, it is essential to conduct clinical and echocardiographic follow-ups every 6–12 months. Follow-up cardiac CT can also be useful to confirm satisfactory positioning after procedure (Fig. 2) and to detect early or late prosthesis dysfunction after TVIV, although the exact role of CT in the follow-up of these patients has not been established. Figure 2: View largeDownload slide Fluoroscopy performed during transcatheter valve-in-valve implantation of an aortic bioprosthesis (A). Post-procedural computed tomography scan performed to ensure that aortic transcatheter valve-in-valve implantations are satisfactory (B, C). Figure 2: View largeDownload slide Fluoroscopy performed during transcatheter valve-in-valve implantation of an aortic bioprosthesis (A). Post-procedural computed tomography scan performed to ensure that aortic transcatheter valve-in-valve implantations are satisfactory (B, C). Cases of TVIV implant degeneration have been treated by transcatheter aortic valve-in-valve-in-valve replacement [48], but it is difficult to assess how far this ‘Russian doll system’ may benefit patients given the iterative reduction in effective orifice area and increase in gradients that occur with each subsequent TVIV procedure. TVIV implantation requires extensive preparation with emphasis on the size of the bioprosthesis selected for implantation. Cardiovascular CT imaging provides key information on the internal diameter of the bioprosthesis, the distance between the annulus and the coronary arteries and the diameter of the access sites. The goal of this careful evaluation is to avoid 2 major complications during the procedure: malposition of the TVIV and coronary occlusion. Malposition of an aortic TVIV induces major aortic periprosthetic leakage or coronary occlusion and is more common in stentless bioprostheses because of the lack of fluoroscopic markers to guide the TVIV implantation procedure. Coronary occlusion is a rare (2.3%), but very serious (52% mortality), complication of TVIV implantation [49]. There may be a higher risk of coronary occlusion with bioprostheses containing cusps sewn outside of the sewing ring (Sorin Mitroflow, St-Jude Trifecta) due to the length of these cusps, particularly in patients with small aortic roots. For procedures at high risk of coronary occlusion, redo SAVR associated with coronary artery bypass grafting remains the first therapeutic option. However, in case of prohibitive surgical risk, the heart team can discuss TVIV implantation combined with a bailout procedure such as having a guidewire and a stent ready to be deployed into the coronary artery at risk of occlusion, as well as backup emergency coronary artery bypass grafting in case of complications. Transcatheter valve-in-valve implantation versus redo aortic valve replacement To date, no randomized prospective study has compared TVIV implantation and redo SAVR. Three retrospective studies have reported similar mortality rates for TVIV implantation and redo SAVR after 30 days (approximately 4–5%) [23, 24, 26]. However, patients treated by TVIV implantation were older and had a higher logistic EuroSCORE than patients treated by redo SAVR. Finally, the postoperative mean transprosthetic gradient was higher for the patients treated by TVIV implantation. Paravalvular leaks were more common after TVIV implantation than after redo SAVR [23]. A recent meta-analysis that included 5 observational studies (n = 342) found no statistical difference in procedural mortality, 30-day mortality and cardiovascular mortality at a mean follow-up period of 18 months. The authors concluded that (i) TVIV implantation was a safe and feasible alternative to redo aortic valve surgery that may offer an effective, less invasive treatment for patients with failed surgical aortic bioprostheses who are inoperable or at high risk and (ii) redo surgery should remain the standard of care particularly in the low-risk population, because it offers superior haemodynamic outcomes with low mortality rates [25]. ASSESSMENT AND TREATMENT International guidelines statements The latest European Society of Cardiology (ESC) guidelines of 2017 recommend that a bioprosthesis should be considered in patients older than 65 years in the aortic position or those with a life expectancy lower than the presumed durability of the bioprosthesis, whereas mechanical prosthesis should be offered only to patients younger than 60 years. For patients between the ages of 60 and 65 years, both types of prosthesis can be considered [50]. Given the improvements in bioprosthesis durability and the results published in recent years on TVIV implantation, the 2017 American Heart Association/American College of Cardiology (AHA/ACC) Focused Update of Guidelines for the Management of Patients With Valvular Heart Disease are going further by reserving mechanical prostheses only to patients under 50 years of age, due to a high risk of structural deterioration at 15 years [51]. For patients between the ages of 50 and 70 years, a mechanical prosthesis or a bioprosthesis may be used. The choice must then be individualized and the risk of long-term anticoagulant treatment needs to be compared with the risk of a repeat intervention (TVIV procedure or redo surgery). Factors to consider include benefit/risk ratio of a long-term anticoagulation, predicted compliance with close International Normalized Ratio (INR) monitoring, expected valve durability, expected haemodynamics for a specific valve type and size, the need for a surgical redo surgery or the possibility of TVIV intervention in case of SVD, patient values and preferences. The prospect of TVIV implantation in case of SVD is often attractive for patients and physicians, as it avoids a second surgery. However, results on long-term follow-up are limited, and redo surgery is sometimes preferable, especially for patients with a smaller-sized bioprosthesis. Multidisciplinary team approach for transcatheter valve-in-valve procedure: why is it so important? Current guidelines recommend a multidisciplinary heart team to facilitate shared decision-making regarding strategies for patients with severe valvular heart disease aimed to better support the patient selection and referring process [52]. There is increasing evidence that treatment decisions for patients with severe aortic valve disease are best made through a process of shared decision-making that includes the patient, the patient’s family, an interventional cardiologist, a cardiac surgeon and ideally, the patient’s general cardiologist or primary care physician (Fig. 3). The latter plays a substantial role in decision-making as they are well versed with the progression of aortic valve disease over time and have intimate knowledge on the patient’s comorbidities. This approach is useful for assessment of the patient’s risk–benefit best advocated by primary care physicians. The choice of treatment of failed bioprosthesis should be made with input from expertise teams performing TVIV implantation and/or SAVR. As a by-product of familiarity with TAVR procedures, increasing number of aortic bioprosthetic surgical valves presenting with SVD are treated by TVIV implantations. Moreover, there is a drive to routinely perform TVIV procedures in the near future even in younger patients and intermediate-risk patients. A potential ethical concern is the implantation of aortic bioprostheses in younger patients who refuse the anticoagulant treatment and prefer redo intervention (surgery or TVIV). In the future, the unvalidated trend of implanting aortic bioprostheses in younger patients with the aim of performing TVIV procedures in case of future SVD may result in ‘a boomerang return effect’ with younger patients presenting with smaller functional aortic surfaces and/or more frequent mismatches. This concern may very soon become a topic of discussion for the multidisciplinary heart team in patients who will be exposed to a lifetime of repeat interventions (TVIV or redo SAVR). For surgeons, the intervention strategy is deemed successful when the maximum durability of the bioprosthetic aortic valves is achieved, while minimizing early postoperative gradients. Aortic valve surgery will be performed concurrently with selective use of root enlargement to permit better effective orifice, thereby justifying these goals once the risk is minimized [25]. Figure 3: View largeDownload slide Clinical perspective and take-home messages. The need for a multidisciplinary management is shown: a process of shared decision-making including the patient, cardiologists, imaging specialists, specialist in geriatrics, anaesthetist and cardiac surgeon. The role played by the patient’s primary care physician allows for a comprehensive knowledge of patient’s background and life style that can, therefore, help in understanding the risk profile and the level of care potentially needed after procedure. We, therefore, believe that implementing a systematic approach based on a multidisciplinary team effort is crucial in the management of these patients. A multidisciplinary approach, involving different professionals contributing with their expertise to the decision-making, should converge towards an early referral of the patient to specialized centres with the aim of performing surgery or TVIV at an early stage according to the patient’s condition. CT: computed tomography; SVD: structural valve deterioration; TVIV: transcatheter valve-in-valve. Figure 3: View largeDownload slide Clinical perspective and take-home messages. The need for a multidisciplinary management is shown: a process of shared decision-making including the patient, cardiologists, imaging specialists, specialist in geriatrics, anaesthetist and cardiac surgeon. The role played by the patient’s primary care physician allows for a comprehensive knowledge of patient’s background and life style that can, therefore, help in understanding the risk profile and the level of care potentially needed after procedure. We, therefore, believe that implementing a systematic approach based on a multidisciplinary team effort is crucial in the management of these patients. A multidisciplinary approach, involving different professionals contributing with their expertise to the decision-making, should converge towards an early referral of the patient to specialized centres with the aim of performing surgery or TVIV at an early stage according to the patient’s condition. CT: computed tomography; SVD: structural valve deterioration; TVIV: transcatheter valve-in-valve. Although the TVIV concept is actually a valuable option for treating high-risk patients with degenerated bioprostheses, very little data exist on the valve-in-valve concept for treating all patients with SVD as an alternative procedure to standard redo aortic surgery. Potential complication and adverse event after TVIV procedure such as coronary obstruction, device mal-positioning, elevated post-procedural gradients and severe patient–prosthesis mismatch after TVIV procedure need to be further studied. Transcatheter valve-in-valve implantation and redo valve surgery: 2 complementary approaches With the emergence of TVIV implantation and the long experience of redo surgery, we now have 2 complementary therapies permitting an individualized approach. To help clinicians in decision making, we suggest an algorithm based on type of bioprosthesis failure, age, comorbidities, operative risk, anatomical factors, anticipated risks and benefits of each alternative, patient’s choice and local experience (Fig. 4). The choice of treatment depends first on the type of bioprosthesis failure. In IE, redo surgery is the only option. In patients presenting with periprosthetic leaks, either percutaneous transcatheter closure or redo surgery can be considered. Bioprosthesis thrombosis should be first treated using optimized anticoagulation, and surgery should be discussed in the absence of improvement. For patients with SVD, redo aortic valve surgery should be considered as first-line treatment for SVD of a small-calibre bioprosthesis (≤21 mm), especially in young patients with pre-existent severe mismatch, if the risk level of the procedure is not excessive. For patients contraindicated or at high risk for redo surgery, the heart team should suggest TVIV implantation as a first-line treatment for severe symptomatic SVD of aortic bioprosthesis. However, some patients are good candidates for TVIV implantation and redo surgery. The spontaneous choice of the patient is to choose a less-invasive treatment and thus to prefer TVIV in case of SVD. However, the role of the heart team is to give full explanations on both types of procedure (immediate results but also long-term results, i.e. long durability of surgical bioprosthesis and lack of long-term follow-up after TVIV) and to clearly recommend redo surgery when it provides the best long-term outcomes with a low operative risk. Figure 4: View largeDownload slide Algorithm to guide clinical decision-making for patients presenting with aortic surgical bioprosthesis dysfunction. Figure 4: View largeDownload slide Algorithm to guide clinical decision-making for patients presenting with aortic surgical bioprosthesis dysfunction. As previously mentioned, cases of patient–prosthesis mismatch after the first aortic procedure should also be addressed using redo surgery consisting of redo AVR and widening of the annulus when possible to implant a larger bioprosthetic valve. However, these patients are sometimes contraindicated for redo surgery, leading one to reconsider TVIV implantation. Recently, several authors have reported the more favourable haemodynamic performance of high (more supra-annular) TVIV implantation [53, 54]. In case of small-diameter bioprosthesis and prohibitive risk for redo surgery, TVIV implantation using a self-expandable prosthesis with supra-annular leaflet could be discussed as an alternative to redo surgery in high-risk patients. Furthermore, the recent development of surgical bioprosthesis specifically designed for later TVIV implantation is attractive, especially in patients at risk of pre-existing severe patient–prosthesis mismatch. For example, the INSPIRIS valve (Edwards Lifesciences), recently approved by the U.S. Food and Drug Administration, has an expandable stent frame, as well as fluoroscopically visible size markers, which may facilitate and optimize a future TVIV procedure. For high-risk patients presenting with smaller bioprosthesis at high risk of post-TVIV elevated gradients, it is possible to fracture the stent of the bioprosthesis by pre-dilation with an oversized non-compliant balloon to facilitate TVIV implantation using either balloon-expandable or self-expanding transcatheter heart valve and potentially reduce residual transvalvular gradients [45, 55]. CONCLUSION Aortic TVIV implantation is an excellent alternative to redo aortic valve surgery because it enables the successful treatment of very high-risk patients using a minimally invasive approach, thus allowing quick postoperative recovery. However, TVIV implantation may lead to an increase in mean aortic gradient (especially for small-calibre bioprosthetic valves), and the long-term effects remain unclear. For young low-risk patients presenting with stenosis-type degeneration of a small-calibre aortic bioprosthesis (≤21 mm), redo aortic valve surgery should be preferred. With the emergence of TVIV implantation and the long experience of redo valve surgery, the heart team currently has 2 complementary treatment modalities, allowing for a tailor-made and patient-orientated intervention. Based on the evolving experience since the introduction of TAVR [56, 57], implementation of percutaneous approaches such as TVIV implantation often leads to a rapid increase in the number of procedures, beginning with high-risk patients and moving towards younger and lower-risk patients. However, randomized clinical trials should be conducted before the indications for TVIV implantations are extended to lower-risk and younger patients in case of SVD. Conflict of interest: none declared. REFERENCES 1 Brown JM , O’Brien SM , Wu C , Sikora JA , Griffith BP , Gammie JS. Isolated aortic valve replacement in North America comprising 108,687 patients in 10 years: changes in risks, valve types, and outcomes in the Society of Thoracic Surgeons National Database . J Thorac Cardiovasc Surg 2009 ; 137 : 82 – 90 . Google Scholar CrossRef Search ADS 2 Mohr FW. Decade in review–valvular disease: current perspectives on treatment of valvular heart disease . Nat Rev Cardiol 2014 ; 11 : 637 – 8 . 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How to treat severe symptomatic structural valve deterioration of aortic surgical bioprosthesis: transcatheter valve-in-valve implantation or redo valve surgery?

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Oxford University Press
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© The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
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Abstract

Abstract The optimal management of aortic surgical bioprosthesis presenting with severe symptomatic structural valve deterioration is currently a matter of debate. Over the past 20 years, the number of implanted bioprostheses worldwide has been rapidly increasing at the expense of mechanical prostheses. A large proportion of patients, however, will require intervention for bioprosthesis structural valve deterioration. Current options for older patients who often have severe comorbidities include either transcatheter valve-in-valve (TVIV) implantation or redo valve surgery. The emergence of TVIV implantation, which is perceived to be less invasive than redo valve surgery, offers an effective alternative to surgery for these patients with proven safety and efficacy in high-risk patient groups including elderly and frail patients. A potential caveat to this strategy is that results of long-term follow-up after TVIV implantation are limited. Redo surgery is sometimes preferable, especially for young patients with a smaller-sized aortic bioprosthesis. With the emergence of TVIV implantation and the long experience of redo valve surgery, we currently have 2 complementary treatment modalities, allowing a tailor-made and patient-orientated intervention. In the heart team, the decision-making should be based on several factors including type of bioprosthesis failure, age, comorbidities, operative risk, anatomical factors, anticipated risks and benefits of each alternative, patient’s choice and local experience. The aim of this review is to provide a framework for individualized optimal treatment strategies in patients with failed aortic surgical bioprosthesis. Valve-in-valve , Transcatheter valve implantation , Bioprosthesis , Redo valve surgery , Structural valve deterioration INTRODUCTION Over the past 20 years, the number of implanted bioprostheses worldwide has been increasing rapidly at the expense of mechanical prostheses [1], with a marked acceleration since the implementation of transcatheter aortic valve replacement (TAVR) procedures [2]. In 2016, 89% of all aortic prostheses surgically implanted in Germany were bioprostheses [3]. This trend is particularly marked in younger patients. Several factors may explain the substantial increase in the number of implanted bioprostheses: the decrease in the incidence of rheumatic valvulopathy in the West, the current predominance of degenerative valvulopathies in older patients, the extended durability of some bioprostheses and, in particular, the availability of transcatheter valve-in-valve (TVIV) implantation in case of structural deterioration. Indeed, the main disadvantage of bioprosthesis is the risk of structural valve deterioration (SVD) in the short term or medium term with the need for repeat surgery, in patients who are older and more fragile. The emergence of TVIV procedures, perceived as less invasive than redo valve surgery for an elderly patient, offers an effective alternative for these patients and has influenced the decision to choose a bioprosthesis over mechanical prostheses, particularly in middle-aged patients [4]. Compared to mechanical prosthesis, the strategy to implant aortic bioprosthesis at the first operation and to perform TVIV implantation in case of SVD allows to avoid the mandatory lifelong vitamin K antagonist therapy. Indeed, long-term anticoagulant therapy can be difficult to maintain in elderly patients due to the bleeding complications and frailty of these patients [5]. Literature search This review was designed by drawing information from a study of Stroup et al. [6]. We started on 1 November 2017 and launched searches on Pub Med, EMBASE and CINAHL using the following search terms: aortic valve replacement and redo surgery, aortic valve replacement and SVD, TVIV—degenerated (or failed) bioprosthetic aortic valve and TVIV versus redo aortic valve surgery. We assessed a large number of publications from 2001 to 2017 in humans who were scheduled for aortic valve redo surgery and those who were treated by redo surgical aortic valve replacement (SAVR) or TVIV implantation. In addition, we searched the Cochrane library by entering the following key words: ‘degenerated bioprosthetic aortic valve’ or ‘redo aortic valve surgery’ or ‘TVIV’ to access titles and abstracts for detailed analysis of the manuscript. The literature has been screened by 2 reviewers (D.A. and F.N.) who analysed the titles and abstracts of all selected studies. Inclusion criteria included completeness and high quality of follow-up >90% and studies with a cohort size ranging from 45 [7] to 3380 patients [8], reflecting the level of centre experience. The target criteria of study included indication for aortic redo surgery due to SVD, mortality and/or morbidity after TVIV or SVAR procedure that were evaluated in patients with prior aortic valve replacement with stented xenograft prosthesis. Particular attention was given to randomized controlled trials and register studies that reported on a large number of patients. When authors addressed multiple publications related to the same patient population, the most recent report was selected. In cases of disagreement, the analysis for review collection data was stopped until an agreement was found. The list of publications overview is reported in Tables 1–3. Table 1: Publications overview: aortic TVIV implantation Authors Year of publication Time span Number of patients Mean age (years) 30-Day mortality (%) 1-Year mortality (%) Eggebrecht et al. [7] 2011 2005–2010 47 80.3 17 NA Dvir et al. [9] 2012 2010–2012 202 77.7 8.4 14.2 Ihlberg et al. [10] 2013 2008–2012 45 80.6 4.4 11.9 Dvir et al. [11] 2014 2007–2013 459 77.6 7.6 16.8 Webb et al. [12] 2017 2011–2016 365 78.9 2.7 12.4 Authors Year of publication Time span Number of patients Mean age (years) 30-Day mortality (%) 1-Year mortality (%) Eggebrecht et al. [7] 2011 2005–2010 47 80.3 17 NA Dvir et al. [9] 2012 2010–2012 202 77.7 8.4 14.2 Ihlberg et al. [10] 2013 2008–2012 45 80.6 4.4 11.9 Dvir et al. [11] 2014 2007–2013 459 77.6 7.6 16.8 Webb et al. [12] 2017 2011–2016 365 78.9 2.7 12.4 NA: not available; NS: no significant; TVIV: transcatheter valve-in-valve. Table 1: Publications overview: aortic TVIV implantation Authors Year of publication Time span Number of patients Mean age (years) 30-Day mortality (%) 1-Year mortality (%) Eggebrecht et al. [7] 2011 2005–2010 47 80.3 17 NA Dvir et al. [9] 2012 2010–2012 202 77.7 8.4 14.2 Ihlberg et al. [10] 2013 2008–2012 45 80.6 4.4 11.9 Dvir et al. [11] 2014 2007–2013 459 77.6 7.6 16.8 Webb et al. [12] 2017 2011–2016 365 78.9 2.7 12.4 Authors Year of publication Time span Number of patients Mean age (years) 30-Day mortality (%) 1-Year mortality (%) Eggebrecht et al. [7] 2011 2005–2010 47 80.3 17 NA Dvir et al. [9] 2012 2010–2012 202 77.7 8.4 14.2 Ihlberg et al. [10] 2013 2008–2012 45 80.6 4.4 11.9 Dvir et al. [11] 2014 2007–2013 459 77.6 7.6 16.8 Webb et al. [12] 2017 2011–2016 365 78.9 2.7 12.4 NA: not available; NS: no significant; TVIV: transcatheter valve-in-valve. Table 2: Publication overview: redo SAVR (with SAVR as first cardiac surgery) Authors Year of publication Time span Number of patients Mean age (years) Proportion of patients non-eligible for TVIVa (%) Proportion of SVD (%) 30-Day mortality (%) Jones et al. [13] 2001 1969–1998 187 54.7 NA NA 6.4 Jamieson et al. [14] 2003 1975–1999 322 NA 0% 100% 6.8 Potter et al. [15] 2005 1993–2001 162 64 56.5 (13% IE) 43.5% 5 Eitz et al. [16] 2006 1991–2004 71 All ≥80 years 23.9 (11.3% IE) 76.1% 16.4 Davierwala et al. [17] 2006 1990–2002 216 59 10 (7.9% IE) NA 4.6 Leontyev et al. [18] 2011 1994–2008 155 58.1 45.2 (27.1% IE) 23.8% 3.5 Chan et al. [19] 2012 1971–2008 437 58.6 NA NA 6 Ruggieri et al. [20] 2013 1975–2011 164 67.8 42.7% 57.3% 10.6 Onorati et al. [21] 2015 2003–2013 324 31.2% >75 years 33% IE 55.2% 7.7 Kaneko et al. [8] 2015 2011–2013 3380 66 13.1% IE NA 4.6 Naji et al. [22] 2015 2000–2012 276 (stenotic bioprosthesis) 64 5% IE 0.5% thrombosis 95% (47% with size ≤21 mm) 2.5 Authors Year of publication Time span Number of patients Mean age (years) Proportion of patients non-eligible for TVIVa (%) Proportion of SVD (%) 30-Day mortality (%) Jones et al. [13] 2001 1969–1998 187 54.7 NA NA 6.4 Jamieson et al. [14] 2003 1975–1999 322 NA 0% 100% 6.8 Potter et al. [15] 2005 1993–2001 162 64 56.5 (13% IE) 43.5% 5 Eitz et al. [16] 2006 1991–2004 71 All ≥80 years 23.9 (11.3% IE) 76.1% 16.4 Davierwala et al. [17] 2006 1990–2002 216 59 10 (7.9% IE) NA 4.6 Leontyev et al. [18] 2011 1994–2008 155 58.1 45.2 (27.1% IE) 23.8% 3.5 Chan et al. [19] 2012 1971–2008 437 58.6 NA NA 6 Ruggieri et al. [20] 2013 1975–2011 164 67.8 42.7% 57.3% 10.6 Onorati et al. [21] 2015 2003–2013 324 31.2% >75 years 33% IE 55.2% 7.7 Kaneko et al. [8] 2015 2011–2013 3380 66 13.1% IE NA 4.6 Naji et al. [22] 2015 2000–2012 276 (stenotic bioprosthesis) 64 5% IE 0.5% thrombosis 95% (47% with size ≤21 mm) 2.5 a IE, paraprosthetic leaks, thrombosis. IE: infective endocarditis; SAVR: surgical aortic valve replacement; SVD: structural valve deterioration; TVIV: transcatheter valve-in-valve. Table 2: Publication overview: redo SAVR (with SAVR as first cardiac surgery) Authors Year of publication Time span Number of patients Mean age (years) Proportion of patients non-eligible for TVIVa (%) Proportion of SVD (%) 30-Day mortality (%) Jones et al. [13] 2001 1969–1998 187 54.7 NA NA 6.4 Jamieson et al. [14] 2003 1975–1999 322 NA 0% 100% 6.8 Potter et al. [15] 2005 1993–2001 162 64 56.5 (13% IE) 43.5% 5 Eitz et al. [16] 2006 1991–2004 71 All ≥80 years 23.9 (11.3% IE) 76.1% 16.4 Davierwala et al. [17] 2006 1990–2002 216 59 10 (7.9% IE) NA 4.6 Leontyev et al. [18] 2011 1994–2008 155 58.1 45.2 (27.1% IE) 23.8% 3.5 Chan et al. [19] 2012 1971–2008 437 58.6 NA NA 6 Ruggieri et al. [20] 2013 1975–2011 164 67.8 42.7% 57.3% 10.6 Onorati et al. [21] 2015 2003–2013 324 31.2% >75 years 33% IE 55.2% 7.7 Kaneko et al. [8] 2015 2011–2013 3380 66 13.1% IE NA 4.6 Naji et al. [22] 2015 2000–2012 276 (stenotic bioprosthesis) 64 5% IE 0.5% thrombosis 95% (47% with size ≤21 mm) 2.5 Authors Year of publication Time span Number of patients Mean age (years) Proportion of patients non-eligible for TVIVa (%) Proportion of SVD (%) 30-Day mortality (%) Jones et al. [13] 2001 1969–1998 187 54.7 NA NA 6.4 Jamieson et al. [14] 2003 1975–1999 322 NA 0% 100% 6.8 Potter et al. [15] 2005 1993–2001 162 64 56.5 (13% IE) 43.5% 5 Eitz et al. [16] 2006 1991–2004 71 All ≥80 years 23.9 (11.3% IE) 76.1% 16.4 Davierwala et al. [17] 2006 1990–2002 216 59 10 (7.9% IE) NA 4.6 Leontyev et al. [18] 2011 1994–2008 155 58.1 45.2 (27.1% IE) 23.8% 3.5 Chan et al. [19] 2012 1971–2008 437 58.6 NA NA 6 Ruggieri et al. [20] 2013 1975–2011 164 67.8 42.7% 57.3% 10.6 Onorati et al. [21] 2015 2003–2013 324 31.2% >75 years 33% IE 55.2% 7.7 Kaneko et al. [8] 2015 2011–2013 3380 66 13.1% IE NA 4.6 Naji et al. [22] 2015 2000–2012 276 (stenotic bioprosthesis) 64 5% IE 0.5% thrombosis 95% (47% with size ≤21 mm) 2.5 a IE, paraprosthetic leaks, thrombosis. IE: infective endocarditis; SAVR: surgical aortic valve replacement; SVD: structural valve deterioration; TVIV: transcatheter valve-in-valve. Table 3: Publication overview: TVIV implantation versus rAVR Authors Year of publication Time span Number of patients (TVIV vs rAVR) Mean age (years) Post-procedure mean gradient (mmHg) (TVIV vs rAVR) 30-Day mortality (%) (TVIV vs rAVR) Erlebach et al. [23] 2015 2001–2014 50 TVIV vs 52 rAVR TVIV 78.1 18.8 ± 8.7 vs 13.8 ± 5.4, P = 0.008 4% vs 0%, P = 0.24 rAVR 66.2 Silaschi et al. [24] 2016 2002–2015 71 TVIV vs 59 rAVR TVIV 78.6 19.7 ± 7.7 vs 12.2 ± 5.7, P < 0.01 4.2% vs 5.1%, P = 1 rAVR 72.9 Gozdek et al. [25] 2017 NA 176 TVIV vs 166 rAVR TVIV 75.3 No significant difference 5.4% vs 4.6%, P = NS rAVR 69 Spaziano et al. [26] 2017 2007–2015 78 TVIV vs 78 rAVR TVIV 77.4 18.1 ± 7.4 vs 14.3 ± 6.2, P = 0.01 3.9% vs 6.4%, P = 0.49 rAVR 78 Authors Year of publication Time span Number of patients (TVIV vs rAVR) Mean age (years) Post-procedure mean gradient (mmHg) (TVIV vs rAVR) 30-Day mortality (%) (TVIV vs rAVR) Erlebach et al. [23] 2015 2001–2014 50 TVIV vs 52 rAVR TVIV 78.1 18.8 ± 8.7 vs 13.8 ± 5.4, P = 0.008 4% vs 0%, P = 0.24 rAVR 66.2 Silaschi et al. [24] 2016 2002–2015 71 TVIV vs 59 rAVR TVIV 78.6 19.7 ± 7.7 vs 12.2 ± 5.7, P < 0.01 4.2% vs 5.1%, P = 1 rAVR 72.9 Gozdek et al. [25] 2017 NA 176 TVIV vs 166 rAVR TVIV 75.3 No significant difference 5.4% vs 4.6%, P = NS rAVR 69 Spaziano et al. [26] 2017 2007–2015 78 TVIV vs 78 rAVR TVIV 77.4 18.1 ± 7.4 vs 14.3 ± 6.2, P = 0.01 3.9% vs 6.4%, P = 0.49 rAVR 78 rAVR: redo aortic valve replacement; TVIV: transcatheter valve-in-valve. Table 3: Publication overview: TVIV implantation versus rAVR Authors Year of publication Time span Number of patients (TVIV vs rAVR) Mean age (years) Post-procedure mean gradient (mmHg) (TVIV vs rAVR) 30-Day mortality (%) (TVIV vs rAVR) Erlebach et al. [23] 2015 2001–2014 50 TVIV vs 52 rAVR TVIV 78.1 18.8 ± 8.7 vs 13.8 ± 5.4, P = 0.008 4% vs 0%, P = 0.24 rAVR 66.2 Silaschi et al. [24] 2016 2002–2015 71 TVIV vs 59 rAVR TVIV 78.6 19.7 ± 7.7 vs 12.2 ± 5.7, P < 0.01 4.2% vs 5.1%, P = 1 rAVR 72.9 Gozdek et al. [25] 2017 NA 176 TVIV vs 166 rAVR TVIV 75.3 No significant difference 5.4% vs 4.6%, P = NS rAVR 69 Spaziano et al. [26] 2017 2007–2015 78 TVIV vs 78 rAVR TVIV 77.4 18.1 ± 7.4 vs 14.3 ± 6.2, P = 0.01 3.9% vs 6.4%, P = 0.49 rAVR 78 Authors Year of publication Time span Number of patients (TVIV vs rAVR) Mean age (years) Post-procedure mean gradient (mmHg) (TVIV vs rAVR) 30-Day mortality (%) (TVIV vs rAVR) Erlebach et al. [23] 2015 2001–2014 50 TVIV vs 52 rAVR TVIV 78.1 18.8 ± 8.7 vs 13.8 ± 5.4, P = 0.008 4% vs 0%, P = 0.24 rAVR 66.2 Silaschi et al. [24] 2016 2002–2015 71 TVIV vs 59 rAVR TVIV 78.6 19.7 ± 7.7 vs 12.2 ± 5.7, P < 0.01 4.2% vs 5.1%, P = 1 rAVR 72.9 Gozdek et al. [25] 2017 NA 176 TVIV vs 166 rAVR TVIV 75.3 No significant difference 5.4% vs 4.6%, P = NS rAVR 69 Spaziano et al. [26] 2017 2007–2015 78 TVIV vs 78 rAVR TVIV 77.4 18.1 ± 7.4 vs 14.3 ± 6.2, P = 0.01 3.9% vs 6.4%, P = 0.49 rAVR 78 rAVR: redo aortic valve replacement; TVIV: transcatheter valve-in-valve. RESULTS Structural valve deterioration of bioprostheses The main disadvantage of bioprostheses is the risk of SVD leading to intraprosthetic regurgitation, stenosis or both (mixed type). Indeed, morphological SVD may be associated to severe haemodynamic changes [27, 28]. For aortic bioprosthesis, severe regurgitation-type SVD [defined by regurgitant orifice area >0.30 cm2 or vena contracta >6 mm or new or worsening (>2+/4+) from baseline] is usually caused by wear and tear or flail of the cusps, whereas severe stenosis-type SVD (mean transprosthetic gradient ≥ 40 mmHg or mean transprosthetic gradient ≥ 20 mmHg change from baseline) may be linked to fibrosis, calcification or pannus deposition (Fig. 1) [27, 29]. Therefore, redo valve surgery may be necessary to address SVD of a bioprosthetic valve, alongside other aetiologies of bioprosthesis dysfunction, such as endocarditis or paraprosthetic leak. Figure 1: View largeDownload slide Explanted aortic bioprosthesis for stenosis-type structural valve deterioration. Presence of severe calcification of the leaflets. Figure 1: View largeDownload slide Explanted aortic bioprosthesis for stenosis-type structural valve deterioration. Presence of severe calcification of the leaflets. Bourguignon et al. [30] published the results of a long-term follow-up conducted on 2659 patients 20 years after the implantation of Carpentier-Edwards Perimount aortic pericardial bioprostheses (Edwards Lifesciences, Irvine, CA, USA). In patients aged ≤60 years, freedom from reoperation due to SVD at 15 years was 70.8% ± 4.1%, with a low mortality rate (2.3%) for reoperation, when needed. The expected valve durability was 17.6 years for patients aged ≤60 years compared to 19.7 years for the entire cohort [30, 31]. However, not all bioprosthetic surgical valves have the same durability [32, 33]. In fact, Senage et al. [34] have reported a risk of rapid SVD for the Mitroflow bioprosthesis valve (Sorin Group Inc.), especially in small-calibre bioprosthesis (19–21 mm), where it significantly impacted the 5-year mortality rate. This predilection for early SVD has been recently confirmed by other reports, especially for smaller bioprostheses [35, 36]. Redo aortic valve replacement In elderly patients with comorbidities, redo aortic valve surgery may confer a higher risk of mortality than the initial surgery [13, 37]. However, the risk of death depends mainly on the comorbidities and the reasons for redo SAVR. Thus, it is important to emphasize that the risk of mortality is much higher for redo SAVR related to infective endocarditis (IE) or periprosthetic leaks than for SVD [13, 38]. In series reporting patients with IE undergoing redo SAVR, the operative mortality may exceed 10% [16, 20]. Other main risk factors of mortality include preoperative left ventricular ejection fraction (LVEF) <30%, preoperative New York Heart Association (NYHA) class III–IV, age >75 years, renal failure or concomitant chronic obstructive pulmonary disease [21, 39]. In Europe, an international multicentre registry reported that the rate of in-hospital mortality after repeat SAVR (i.e. reintervention on aortic valve prosthesis for failure or endocarditis of a previous AVR) was 7.7% [21]. When considering redo SAVR for SVD of a previous AVR, Jamieson et al. [14] have reported a similar operative mortality at 6.8% in a series of 322 patients in a period between 1975 and 1999. However, the operative mortality has decreased during recent years and now approaches that of the primary surgery. Thus, Naji et al. [22] have recently reported excellent outcomes for patients with severe stenotic bioprostheses undergoing redo SAVR with a 30-day mortality at 2.5%. In elderly patients, Onorati et al. [40] recently reported similar immediate postoperative outcomes for octogenarians and younger patients, with an in-hospital mortality rate of 3% and a 5-year survival rate of 83%. Although the mortality rate is acceptable, there is significant morbidity involved, such as haemodynamic instability, acute renal failure and prolonged intubation. There are also longer periods of aortic clamping and extracorporeal circulation, and a higher risk of bleeding and transfusions [21]. Redo surgery is associated with a higher risk of scar tissue, adhesions and iatrogenic effects on adjacent structures, with higher risk of post-operative pacemaker. Finally, a major surgical risk is vascular injury during dissection, causing damage to the bypass graft(s) during redo sternotomy. This life-threatening complication may be prevented by a preoperative computed tomography (CT) scan to visualize the relationship between the mediastinal contents and the sternum, and to identify the patients at risk of injury during re-entry. Aortic transcatheter valve-in-valve implantation Over the past decade, TAVR has become the treatment of choice for patients with prohibitive surgical risk and a safe and less invasive alternative to surgery in both high- and intermediate-risk patients with severe symptomatic native aortic stenosis [41–43]. Important breakthroughs were made regarding TVIV implantation using trans-femoral and apical approaches after a few isolated cases were reported [7, 9]. The safety and efficacy of this innovative and less-invasive approach were demonstrated in a high-risk population including elderly and frail patients [9]. One of the largest studies of aortic TVIV therapy is the international multicentre prospective Global Valve-in-Valve Registry [9, 11], which included 459 high-risk patients (mean age 77 years) who underwent aortic TVIV implantation: 40% for stenosis-type degeneration, 30% for regurgitation-type degeneration and 30% for mixed degeneration. On average, the procedure took place 9 years after the first aortic valve surgery (earlier in stenosis-type degeneration compared to regurgitation-type degeneration). Small-calibre bioprosthesis ≤ 21 mm) tended to degenerate more often towards stenosis than large-calibre bioprosthesis (≥ 25 mm), which tended to degenerate towards regurgitation. Mortality rates were 7.6% after 30 days and 16.8% after 1 year. After TVIV implantation, the mean valve-in-valve gradient was significantly higher in stenosis-type degeneration than in regurgitation-type degeneration (18 mmHg vs 12 mmHg, P < 0.001). Multivariate analysis indicated that the main risk factors of all-cause mortality for TVIV implantation were stenosis-type degeneration, small-calibre bioprosthesis surgical valve (≤21 mm), transapical approach for the procedure and a high Society of Thoracic Surgeons (STS) score [11]. Webb et al. [12] have also recently reported excellent outcomes for 365 high-risk patients (mean age 78.9 ± 10.2 years, mean STS score 9.1 ± 4.7%) with a very low 30-day mortality at 2.7% and a 1-year mortality at 12.4%, with an important effect on the procedural learning curve. However, long-term follow-up data are not available. In these publications, the causes of death were not reported, but the residual mean gradient after TVIV implantation was probably a major factor. Thus, Webb et al. [12] have shown that elevated transvalvular gradients (≥20 mmHg) after TVIV implantation was correlated to an increased 1-year mortality. Eggebrecht et al. [7] also reported a high proportion of patients (44%) with elevated transvalvular gradients (≥20 mmHg) after TVIV implantation, especially for those with degenerated surgical bioprostheses of small diameters. The smaller the degenerated bioprosthesis is, the higher the risk of an increase in mean gradient after TVIV implantation exists, because the TVIV prosthesis is inserted inside a non-elastic stent of the surgical bioprosthesis, thus predisposing to underexpansion of the TVIV prosthesis and leading to a smaller effective orifice area than when it is more fully expanded in a native aortic annulus [44]. Furthermore, Pibarot et al. [45] recently published a study indicating that pre-existing severe patient–prosthesis mismatch (more frequent with smaller bioprosthetic valves) was associated with a higher prevalence of elevated transaortic gradient after TVIV implantation and with 2.4- and 1.8-fold higher rates of 30-day mortality and 1-year mortality, respectively. Stenosis-type bioprosthesis degeneration increases the risk of mortality, potentially due to pressure-overload-induced remodelling and concentric left ventricular hypertrophy, which may result in heart failure with preserved LVEF, worsened by an elevated mean gradient after TVIV implantation. Many questions persist regarding outcomes of patients who have benefited from TVIV implantation: the longevity of the valve-in-valve bioprosthesis, the potential risk of rapid SVD especially with smaller bioprosthesis and the risks of bioprosthetic valve thrombosis. Compared to the wealth of knowledge on aortic surgical bioprosthesis longevity, there is indeed very scarce data concerning mid-term outcomes of patients treated using percutaneous approach: 5 years in TAVR [46, 47] and 1 year for TVIV implantation [11, 12]. Therefore, it is essential to conduct clinical and echocardiographic follow-ups every 6–12 months. Follow-up cardiac CT can also be useful to confirm satisfactory positioning after procedure (Fig. 2) and to detect early or late prosthesis dysfunction after TVIV, although the exact role of CT in the follow-up of these patients has not been established. Figure 2: View largeDownload slide Fluoroscopy performed during transcatheter valve-in-valve implantation of an aortic bioprosthesis (A). Post-procedural computed tomography scan performed to ensure that aortic transcatheter valve-in-valve implantations are satisfactory (B, C). Figure 2: View largeDownload slide Fluoroscopy performed during transcatheter valve-in-valve implantation of an aortic bioprosthesis (A). Post-procedural computed tomography scan performed to ensure that aortic transcatheter valve-in-valve implantations are satisfactory (B, C). Cases of TVIV implant degeneration have been treated by transcatheter aortic valve-in-valve-in-valve replacement [48], but it is difficult to assess how far this ‘Russian doll system’ may benefit patients given the iterative reduction in effective orifice area and increase in gradients that occur with each subsequent TVIV procedure. TVIV implantation requires extensive preparation with emphasis on the size of the bioprosthesis selected for implantation. Cardiovascular CT imaging provides key information on the internal diameter of the bioprosthesis, the distance between the annulus and the coronary arteries and the diameter of the access sites. The goal of this careful evaluation is to avoid 2 major complications during the procedure: malposition of the TVIV and coronary occlusion. Malposition of an aortic TVIV induces major aortic periprosthetic leakage or coronary occlusion and is more common in stentless bioprostheses because of the lack of fluoroscopic markers to guide the TVIV implantation procedure. Coronary occlusion is a rare (2.3%), but very serious (52% mortality), complication of TVIV implantation [49]. There may be a higher risk of coronary occlusion with bioprostheses containing cusps sewn outside of the sewing ring (Sorin Mitroflow, St-Jude Trifecta) due to the length of these cusps, particularly in patients with small aortic roots. For procedures at high risk of coronary occlusion, redo SAVR associated with coronary artery bypass grafting remains the first therapeutic option. However, in case of prohibitive surgical risk, the heart team can discuss TVIV implantation combined with a bailout procedure such as having a guidewire and a stent ready to be deployed into the coronary artery at risk of occlusion, as well as backup emergency coronary artery bypass grafting in case of complications. Transcatheter valve-in-valve implantation versus redo aortic valve replacement To date, no randomized prospective study has compared TVIV implantation and redo SAVR. Three retrospective studies have reported similar mortality rates for TVIV implantation and redo SAVR after 30 days (approximately 4–5%) [23, 24, 26]. However, patients treated by TVIV implantation were older and had a higher logistic EuroSCORE than patients treated by redo SAVR. Finally, the postoperative mean transprosthetic gradient was higher for the patients treated by TVIV implantation. Paravalvular leaks were more common after TVIV implantation than after redo SAVR [23]. A recent meta-analysis that included 5 observational studies (n = 342) found no statistical difference in procedural mortality, 30-day mortality and cardiovascular mortality at a mean follow-up period of 18 months. The authors concluded that (i) TVIV implantation was a safe and feasible alternative to redo aortic valve surgery that may offer an effective, less invasive treatment for patients with failed surgical aortic bioprostheses who are inoperable or at high risk and (ii) redo surgery should remain the standard of care particularly in the low-risk population, because it offers superior haemodynamic outcomes with low mortality rates [25]. ASSESSMENT AND TREATMENT International guidelines statements The latest European Society of Cardiology (ESC) guidelines of 2017 recommend that a bioprosthesis should be considered in patients older than 65 years in the aortic position or those with a life expectancy lower than the presumed durability of the bioprosthesis, whereas mechanical prosthesis should be offered only to patients younger than 60 years. For patients between the ages of 60 and 65 years, both types of prosthesis can be considered [50]. Given the improvements in bioprosthesis durability and the results published in recent years on TVIV implantation, the 2017 American Heart Association/American College of Cardiology (AHA/ACC) Focused Update of Guidelines for the Management of Patients With Valvular Heart Disease are going further by reserving mechanical prostheses only to patients under 50 years of age, due to a high risk of structural deterioration at 15 years [51]. For patients between the ages of 50 and 70 years, a mechanical prosthesis or a bioprosthesis may be used. The choice must then be individualized and the risk of long-term anticoagulant treatment needs to be compared with the risk of a repeat intervention (TVIV procedure or redo surgery). Factors to consider include benefit/risk ratio of a long-term anticoagulation, predicted compliance with close International Normalized Ratio (INR) monitoring, expected valve durability, expected haemodynamics for a specific valve type and size, the need for a surgical redo surgery or the possibility of TVIV intervention in case of SVD, patient values and preferences. The prospect of TVIV implantation in case of SVD is often attractive for patients and physicians, as it avoids a second surgery. However, results on long-term follow-up are limited, and redo surgery is sometimes preferable, especially for patients with a smaller-sized bioprosthesis. Multidisciplinary team approach for transcatheter valve-in-valve procedure: why is it so important? Current guidelines recommend a multidisciplinary heart team to facilitate shared decision-making regarding strategies for patients with severe valvular heart disease aimed to better support the patient selection and referring process [52]. There is increasing evidence that treatment decisions for patients with severe aortic valve disease are best made through a process of shared decision-making that includes the patient, the patient’s family, an interventional cardiologist, a cardiac surgeon and ideally, the patient’s general cardiologist or primary care physician (Fig. 3). The latter plays a substantial role in decision-making as they are well versed with the progression of aortic valve disease over time and have intimate knowledge on the patient’s comorbidities. This approach is useful for assessment of the patient’s risk–benefit best advocated by primary care physicians. The choice of treatment of failed bioprosthesis should be made with input from expertise teams performing TVIV implantation and/or SAVR. As a by-product of familiarity with TAVR procedures, increasing number of aortic bioprosthetic surgical valves presenting with SVD are treated by TVIV implantations. Moreover, there is a drive to routinely perform TVIV procedures in the near future even in younger patients and intermediate-risk patients. A potential ethical concern is the implantation of aortic bioprostheses in younger patients who refuse the anticoagulant treatment and prefer redo intervention (surgery or TVIV). In the future, the unvalidated trend of implanting aortic bioprostheses in younger patients with the aim of performing TVIV procedures in case of future SVD may result in ‘a boomerang return effect’ with younger patients presenting with smaller functional aortic surfaces and/or more frequent mismatches. This concern may very soon become a topic of discussion for the multidisciplinary heart team in patients who will be exposed to a lifetime of repeat interventions (TVIV or redo SAVR). For surgeons, the intervention strategy is deemed successful when the maximum durability of the bioprosthetic aortic valves is achieved, while minimizing early postoperative gradients. Aortic valve surgery will be performed concurrently with selective use of root enlargement to permit better effective orifice, thereby justifying these goals once the risk is minimized [25]. Figure 3: View largeDownload slide Clinical perspective and take-home messages. The need for a multidisciplinary management is shown: a process of shared decision-making including the patient, cardiologists, imaging specialists, specialist in geriatrics, anaesthetist and cardiac surgeon. The role played by the patient’s primary care physician allows for a comprehensive knowledge of patient’s background and life style that can, therefore, help in understanding the risk profile and the level of care potentially needed after procedure. We, therefore, believe that implementing a systematic approach based on a multidisciplinary team effort is crucial in the management of these patients. A multidisciplinary approach, involving different professionals contributing with their expertise to the decision-making, should converge towards an early referral of the patient to specialized centres with the aim of performing surgery or TVIV at an early stage according to the patient’s condition. CT: computed tomography; SVD: structural valve deterioration; TVIV: transcatheter valve-in-valve. Figure 3: View largeDownload slide Clinical perspective and take-home messages. The need for a multidisciplinary management is shown: a process of shared decision-making including the patient, cardiologists, imaging specialists, specialist in geriatrics, anaesthetist and cardiac surgeon. The role played by the patient’s primary care physician allows for a comprehensive knowledge of patient’s background and life style that can, therefore, help in understanding the risk profile and the level of care potentially needed after procedure. We, therefore, believe that implementing a systematic approach based on a multidisciplinary team effort is crucial in the management of these patients. A multidisciplinary approach, involving different professionals contributing with their expertise to the decision-making, should converge towards an early referral of the patient to specialized centres with the aim of performing surgery or TVIV at an early stage according to the patient’s condition. CT: computed tomography; SVD: structural valve deterioration; TVIV: transcatheter valve-in-valve. Although the TVIV concept is actually a valuable option for treating high-risk patients with degenerated bioprostheses, very little data exist on the valve-in-valve concept for treating all patients with SVD as an alternative procedure to standard redo aortic surgery. Potential complication and adverse event after TVIV procedure such as coronary obstruction, device mal-positioning, elevated post-procedural gradients and severe patient–prosthesis mismatch after TVIV procedure need to be further studied. Transcatheter valve-in-valve implantation and redo valve surgery: 2 complementary approaches With the emergence of TVIV implantation and the long experience of redo surgery, we now have 2 complementary therapies permitting an individualized approach. To help clinicians in decision making, we suggest an algorithm based on type of bioprosthesis failure, age, comorbidities, operative risk, anatomical factors, anticipated risks and benefits of each alternative, patient’s choice and local experience (Fig. 4). The choice of treatment depends first on the type of bioprosthesis failure. In IE, redo surgery is the only option. In patients presenting with periprosthetic leaks, either percutaneous transcatheter closure or redo surgery can be considered. Bioprosthesis thrombosis should be first treated using optimized anticoagulation, and surgery should be discussed in the absence of improvement. For patients with SVD, redo aortic valve surgery should be considered as first-line treatment for SVD of a small-calibre bioprosthesis (≤21 mm), especially in young patients with pre-existent severe mismatch, if the risk level of the procedure is not excessive. For patients contraindicated or at high risk for redo surgery, the heart team should suggest TVIV implantation as a first-line treatment for severe symptomatic SVD of aortic bioprosthesis. However, some patients are good candidates for TVIV implantation and redo surgery. The spontaneous choice of the patient is to choose a less-invasive treatment and thus to prefer TVIV in case of SVD. However, the role of the heart team is to give full explanations on both types of procedure (immediate results but also long-term results, i.e. long durability of surgical bioprosthesis and lack of long-term follow-up after TVIV) and to clearly recommend redo surgery when it provides the best long-term outcomes with a low operative risk. Figure 4: View largeDownload slide Algorithm to guide clinical decision-making for patients presenting with aortic surgical bioprosthesis dysfunction. Figure 4: View largeDownload slide Algorithm to guide clinical decision-making for patients presenting with aortic surgical bioprosthesis dysfunction. As previously mentioned, cases of patient–prosthesis mismatch after the first aortic procedure should also be addressed using redo surgery consisting of redo AVR and widening of the annulus when possible to implant a larger bioprosthetic valve. However, these patients are sometimes contraindicated for redo surgery, leading one to reconsider TVIV implantation. Recently, several authors have reported the more favourable haemodynamic performance of high (more supra-annular) TVIV implantation [53, 54]. In case of small-diameter bioprosthesis and prohibitive risk for redo surgery, TVIV implantation using a self-expandable prosthesis with supra-annular leaflet could be discussed as an alternative to redo surgery in high-risk patients. Furthermore, the recent development of surgical bioprosthesis specifically designed for later TVIV implantation is attractive, especially in patients at risk of pre-existing severe patient–prosthesis mismatch. For example, the INSPIRIS valve (Edwards Lifesciences), recently approved by the U.S. Food and Drug Administration, has an expandable stent frame, as well as fluoroscopically visible size markers, which may facilitate and optimize a future TVIV procedure. For high-risk patients presenting with smaller bioprosthesis at high risk of post-TVIV elevated gradients, it is possible to fracture the stent of the bioprosthesis by pre-dilation with an oversized non-compliant balloon to facilitate TVIV implantation using either balloon-expandable or self-expanding transcatheter heart valve and potentially reduce residual transvalvular gradients [45, 55]. CONCLUSION Aortic TVIV implantation is an excellent alternative to redo aortic valve surgery because it enables the successful treatment of very high-risk patients using a minimally invasive approach, thus allowing quick postoperative recovery. However, TVIV implantation may lead to an increase in mean aortic gradient (especially for small-calibre bioprosthetic valves), and the long-term effects remain unclear. For young low-risk patients presenting with stenosis-type degeneration of a small-calibre aortic bioprosthesis (≤21 mm), redo aortic valve surgery should be preferred. With the emergence of TVIV implantation and the long experience of redo valve surgery, the heart team currently has 2 complementary treatment modalities, allowing for a tailor-made and patient-orientated intervention. 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European Journal of Cardio-Thoracic SurgeryOxford University Press

Published: Jun 2, 2018

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