Surgical Bioprostheses Research Articles

Valve-in-valve procedures for degenerated surgical and transcatheter aortic valve bioprostheses using a latest-generation self-expanding intra-annular transcatheter heart valve.

Valve-in-valve (ViV) transfemoral transcatheter aortic valve implantation (TAVI) for failing aortic surgical bioprostheses or transcatheter heart valves (THV) has demonstrated a reasonable clinical and hemodynamic efficacy. Traditionally, self-expanding (SE) supra-annular THV are considered to result in superior hemodynamics compared with balloon-expandable intra-annular THV after ViV. However, so far no data are found on latest-generation intra-annular SE THV for aortic ViV procedures which might be superior with regard to coronary access or subsequent valve reintervention. We herein aim to evaluate a latest-generation SE intra-annular THV for aortic ViV procedures. Between May 2022 and November 2022, five consecutive patients (4/5 female with mean age of 76.2 years and mean Society of Thoracic Surgeons predicted risk of mortality score of 2.9%) received ViV TAVI using the Navitor system (Abbott, Chicago, IL, USA) for treatment of failing surgical bioprostheses or THV. Data were retrospectively analyzed according to updated Valve Academic Research Consortium 3 (VARC-3) definitions. At 30 days, absence of mortality and VARC-3 adjudicated clinical endpoints were documented. Echocardiography at 30 days revealed complete absence of paravalvular leakage and single-digit mean transvalvular gradients (mean of 6.0 mmHg) in all patients. The investigated intra-annular SE THV results in excellent 30-day outcomes for aortic ViV procedures for failing surgical bioprostheses or THV. Despite the intra-annular design, hemodynamic results were excellent, even in small bioprostheses. Ease of use of this valve platform is reflected by only two cycles of resheathing in five ViV procedures with hemodynamic stability during all steps of valve deployment.

5-Year Prospective Evaluation of Mitral Valve-in-Valve, Valve-in-Ring, and Valve-in-MAC Outcomes: MITRAL Trial Final Results

BackgroundThe MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective trial to evaluate the safety and feasibility of balloon-expandable aortic transcatheter heart valves in patients with failed surgical bioprostheses or annuloplasty rings and severe mitral annular calcification treated with mitral valve-in-valve (MViV), valve-in-ring (MViR), or valve–in–mitral annular calcification (ViMAC). ObjectivesThe aim of this study was to evaluate 5-year outcomes among these patients. MethodsA multicenter prospective study was conducted among patients at high surgical risk at 13 U.S. sites. Patients underwent MViV (n = 30), MViR (n = 30), or ViMAC (n = 31) and were followed annually for 5 years. Kansas City Cardiomyopathy Questionnaire scores were obtained at baseline and follow-up visits. Echocardiograms were analyzed at independent core laboratories. ResultsA total of 91 patients underwent transcatheter mitral valve replacement (February 2015 to December 2017). The mean age was 74.3 ± 8.9 years. At 5-year follow-up, the lowest all-cause mortality was observed in the MViV group (21.4%), 94.7% of patients were in NYHA functional class I or II, and the mean mitral gradient was 6.6 ± 2.5 mm Hg. The MViR and ViMAC groups had higher all-cause mortality (65.5% and 67.9%), most survivors were in NYHA functional classes I and II (50% and 55.6%), and mean mitral gradients remained stable (5.8 ± 0.1 and 6.7 ± 2.5 mm Hg). Significant improvements in Kansas City Cardiomyopathy Questionnaire scores were observed when all 3 arms were pooled. ConclusionsMViV, MViR, and ViMAC procedures were associated with sustained improvement of heart failure symptoms and quality of life among survivors at 5 years. Transcatheter heart valve function remained stable in all 3 groups. Patients treated with MViV had excellent survival at 5 years, whereas survival was lower in the MViR and ViMAC groups, consistent with underlying disease severity. Patients with more residual mitral regurgitation had higher mortality.

Infective Endocarditis After Transcatheter Versus Surgical Aortic Valve Replacement.

Scarce data are available comparing infective endocarditis (IE) following surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). This study aimed to compare the clinical presentation, microbiological profile, management, and outcomes of IE after SAVR versus TAVR. Data were collected from the "Infectious Endocarditis after TAVR International" (enrollment from 2005 to 2020) and the "International Collaboration on Endocarditis" (enrollment from 2000 to 2012) registries. Only patients with an IE affecting the aortic valve prosthesis were included. A 1:1 paired matching approach was used to compare patients with TAVR and SAVR. A total of 1688 patients were included. Of them, 602 (35.7%) had a surgical bioprosthesis (SB), 666 (39.5%) a mechanical prosthesis, 70 (4.2%) a homograft, and 350 (20.7%) a transcatheter heart valve. In the SAVR versus TAVR matched population, the rate of new moderate or severe aortic regurgitation was higher in the SB group (43.4% vs 13.5%; P < .001), and fewer vegetations were diagnosed in the SB group (62.5% vs 82%; P < .001). Patients with an SB had a higher rate of perivalvular extension (47.9% vs 27%; P < .001) and Staphylococcus aureus was less common in this group (13.4% vs 22%; P = .033). Despite a higher rate of surgery in patients with SB (44.4% vs 27.3%; P < .001), 1-year mortality was similar (SB: 46.5%; TAVR: 44.8%; log-rank P = .697). Clinical presentation, type of causative microorganism, and treatment differed between patients with an IE located on SB compared with TAVR. Despite these differences, both groups exhibited high and similar mortality at 1-year follow-up.

Comparison of a Novel Self-Expanding Transcatheter Heart Valve with Two Established Devices for Treatment of Degenerated Surgical Aortic Bioprostheses

Comparison of a Novel Self-Expanding Transcatheter Heart Valve with Two Established Devices for Treatment of Degenerated Surgical Aortic Bioprostheses

P13 THE PHANTOM OF TRICUSPID PROSTHESIS: CASE REPORT OF A PECULIAR TRANSCATHETER TRICUSPID VALVE–IN–VALVE IMPLANTATION

Abstract Background Transcatheter tricuspid valve–in–valve replacement for patients with degenerative tricuspid surgical bioprosthesis disease has emerged in recent years as a new treatment possibility in patients that required tricuspid valve replacement at young age and in circumstances where redo tricuspid valve replacement is not feasible because of the remarkable morbidity and mortality. Case presentation. A 76 year–old Caucasian male was referred to our center for worsening dyspnoea and fatigue. He had a pacemaker implanted for third degree atrio–ventricular block in 1996. After massive endocarditis affecting the tricuspid valve and the pacemaker right ventricular lead, the patient underwent surgical tricuspid valve replacement with a 32 mm Liotta BioImplant L.P.B., right ventricular lead extraction and concomitant epicardial pacemaker reimplantation. Transthoracic echocardiogram at hospital admission denoted a degenerative stenosis of the tricuspid prosthesis with a trans–valvular mean gradient of 8 mmHg associated with right atrial and inferior vena cava dilatation. Given the high surgical risk due to comorbidities (systemic arterial hypertension, paroxysmal atrial fibrillation in DOAC, grade II obesity, smoking history and chronic lymphoproliferative leukemia) the patient was deemed not suitable for a re–do surgical tricuspid valve replacement and was offered a percutaneous replacement. Preprocedural planning with computed tomography allowed accurate reconstruction of the tricuspidal prosthetic annulus and correct sizing of Edwards SAPIEN valve, the most used in valve–in–valve procedures. The degenerated prosthesis was not visible at fluoroscopy meaning no fluoroscopic landmarks available to provide an anatomic view for valve deployment. Therefore, a combination of balloon valvuloplasty and right atrium angiographies before the valve–in–valve deployment were critical to provide the correct valve position and yield the procedure effective and safe. Hemodynamic gradient post–TVIV was absent and no paravalvular leaks were observed. Clinical and echocardiographic improvement were confirmed after the procedure and at 1 year–follow up. Conclusion Tricuspid valve–in–valve replacement can be technically feasible and a safer alternative to re–do surgical valve replacement, also in radiolucent bioprosthesis. In our case the successful procedural outcome not only relied on meticulous planning before the procedure, but also on specific intra–procedural adjustments.

Aortic valve calcification of surgical bioprostheses and its impact on clinical outcome

Aortic valve calcification (AVC) of surgical valve bioprostheses (BP) has been poorly explored. We aimed to evaluate in vivo and ex vivo BP AVC and its prognosis value. Between 2011 and 2019, AVC was assessed in 361 patients with surgical BP on in vivo computed tomography (CT) scanner (6.4 ± 4.3 years after surgery). Follow-up was obtained in all patients. Ex vivo CT-scans were performed in 37 explanted BP. After exclusion of 19 (5.2%) CT-scans, mean in vivo AVC was 307 ± 500 AU in the remaining 342 BP (77 ± 9 years, 64% male). Of these, 183 (53.5%) had a structural valve degeneration (SVD) with an AVC of 562 ± 570 AU compared with 13 ± 43 AU (P < 0.0001) for non-SVD BP. Early calcification was observed in around 10% of BP (12/124) examined before the 3rd postoperative year. In explanted BP in vivo AVC correlated strongly with ex vivo AVC (r = 0.88, P < 0.0001). An in vivo AVC > 100 AU (n = 147, 43%) had an excellent specificity (96%) for diagnosing stage 2–3 SVD. Patients with AVC > 100 AU had worse survival compared with those with an AVC < 100 (n = 195, 57%). In multivariable analyses, AVC value was a predictor of overall mortality (HR = 1.16 [1.04–1.29]; P = 0.009), cardiovascular mortality (HR = 1.21 [1.03–1.41]; P = 0.021) and cardiovascular events (HR = 1.19 [1.08–1.31]; P = 0.001). After further adjustment for SVD diagnosis, AVC remained a predictor of overall mortality (HR = 1.24 [1.07–1.44]; P = 0.005), and cardiovascular events (HR = 1.16 [1.02–1.32]; P = 0.029). CT-scan AVC of surgical BP is a reliable tool for assessing leaflets calcification. Whereas calcification can develop early after surgery, an AVC > 100 AU is tightly associated with SVD, and is a strong predictor of overall mortality and cardiovascular events, even after adjustment for SVD diagnosis. Hence, AVC scoring is a complementary tool to echocardiography that should be used in the follow-up of patients with surgical aortic BP.

Outcomes and Hemodynamic Performances of Transcatheter Aortic Valve Replacement with Two Generations of Self-Expanding Transcatheter Aortic Valves.

The superiority of the new-generation self-expanding Evolut R compared with the first-generation CoreValve with regards to outcomes after transcatheter aortic valve replacement (TAVR) is unclear. The aim of this study was to investigate the hemodynamic and clinical performance of Evolut R compared with its direct predecessor, CoreValve, in a Taiwanese population. This study included all consecutive patients who underwent TAVR with either CoreValve or Evolut R between March 2013 and December 2020. Thirty-day Valve Academic Research Consortium-2 (VARC-2)-defined outcomes and hemodynamic performances were investigated. There were no significant differences in baseline demographic characteristics between the patients receiving CoreValve (n = 117) or Evolut R (n = 117). Aortic valve-in-valve procedures for failed surgical bioprosthesis and procedures under conscious sedation were performed significantly more often with Evolut R. Pre-dilatation was performed significantly more often and contrast media volume was significantly higher with CoreValve. Stroke (0% vs. 4.3%, p = 0.024) and the need for emergent conversion to open surgery (0% vs. 5.1%, p = 0.012) were significantly lower in Evolut R than in CoreValve recipients. Evolut R significantly reduced 30-day composite safety endpoint (4.3% vs. 15.4%, p = 0.004). Advancements in transcatheter valve technologies have resulted in improved outcomes for patients undergoing TAVR with self-expanding valves. With the new-generation Evolut R, device success was high and the 30-day composite safety endpoint was significantly reduced after TAVR compared with CoreValve.

Coronary Perfusion After Valve-in-Valve Transcatheter Aortic Valve Implantation in Small Aortic Root: In Vitro Experimental Assessment.

Coronary flow obstruction following transcatheter aortic valve-in-valve implantation (VIV-TAVI) is associated with a high mortality risk. The aim of this work was to quantify the coronary perfusion after VIV-TAVI in a high-risk aortic root anatomy. 3D printed models of small aortic root were used to simulate the implantation of a TAVI prosthesis (Portico 23) into surgical prostheses (Trifecta 19 and 21). The aortic root models were tested in a pulsatile in vitro bench setup with a coronary perfusion simulator. The tests were performed at baseline and post-VIV-TAVI procedure in aligned and misaligned commissural configurations under simulated hemodynamic rest and exercise conditions. The experimental design provided highly controllable and repeatable flow and pressure conditions. The left and right coronary mean flow did not differ significantly at pre- and post-VIV-TAVI procedure in any tested configurations. The commissural misalignment did not induce any significant alterations to the coronary flow. High-risk aortic root anatomy did not trigger coronary ostia obstruction or coronary flow alteration after transcatheter aortic valve implantation in a surgical bioprosthesis as shown from in-vitro flow loop tests.

Comparison of a novel self-expanding transcatheter heart valve with two established devices for treatment of degenerated surgical aortic bioprostheses

AimsThis study was performed to compare haemodynamic properties of a novel transcatheter heart valve (THV) with two established valve technologies for treatment of failing surgical aortic bioprosthetic valves (SAV). The ALLEGRA THV has been recently described with a proven safety and performance profile.Methods and resultsThe study was designed as a retrospective, single-centre study investigating 112 patients (77.7 ± 7.1 years, 53.8% female, STS score 6.8 ± 5.8% and logEuroSCORE I 27.4 ± 16.1%) with failing SAV. Patients were treated with the ALLEGRA THV (NVT, n = 24), the CoreValve/EvolutR (MTD, n = 64) or the Edwards Sapien/Sapien XT/Sapien 3 (EDW, n = 24). Adverse events, haemodynamic outcomes and patient safety were analysed according to VARC-3 definitions. Overall procedural success was high (94.6%), even though 58.9% of the treated SAV were classified as small (true inner diameter < 21 mm). After treatment, the mean pressure gradient was significantly reduced (baseline: 33.7 ± 16.5 mmHg, discharge: 18.0 ± 7.1 mmHg), with a corresponding increase in effective orifice area (EOA). The complication rates did not differ in between groups. There was a trend to lower mean transvalvular gradients after implantation of self-expanding THV with supra-annular valve function, despite a higher frequency of smaller SAVs in the NVT and MTD group. Additionally, comparison between NVT and MTD revealed statistically lower transvalvular gradients (NVT 14.9 ± 5.0 mmHg, MTD 18.7 ± 7.5 mmHg, p = 0.0295) in a subgroup analysis.ConclusionsValve-in-valve (ViV) treatment of failing SAV with supra-annular design like the ALLEGRA THV resulted in favourable haemodynamic outcomes with similar low clinical event rates and may therefore be an interesting alternative for VIV TAVI.Graphical abstract

Trifecta and Carpentier Edwards aortic bioprostheses: Comparison of six years follow-up outcomes.

To compare mid-term clinical outcomes and hemodynamic performance of the stented pericardial Trifecta bioprosthesis for surgical aortic valve replacement (AVR) with a technically comparable commonly used surgical bioprosthesis. Data from consecutive patients implanted with the TF or the Carpentier Edwards Magna Ease valve were retrospectively analyzed. Primary analysis was performed on a propensity score-matched cohort. Primary endpoints included the composite of death or reoperation and structural valve deterioration. The comparison also included echocardiographic assessments at one-week post-AVR and at the last documented follow-up. Two propensity score-matched groups of 170 patients each were identified from the overall population (n = 486). Incidence of postoperative mortality (2.9% vs. 7.1%, respectively, p = 0.08), and patient prosthesis mismatch (1.2% and 2.4%, p = 0.41) were similar. At mean follow-up of 5.84 (Trifecta) and 6.1 (Carpentier Edwards) years, the incidence of all-cause death/reoperation (15.3% vs. 15.9%, p = 0.88 for Trifecta and Carpentier Edwards, respectively) and structural valve disease (1.8% vs. 2.9%, p = 0.47) were similar. Overall, postoperative mean transvalvular pressure gradients were significantly lower in the Trifecta group than in the Carpentier Edwards group (7.7 ± 3.3 vs. 11.3 ± 3.6 mmHg, p < 0.01). Mean transvalvular gradient remained significantly lower through the last follow-up for small-sized Trifecta valves (19/21 mm; 10.5 ± 4.2 vs. 13.8 ± 5.9 mmHg, p = 0.039) but not for larger valves (10.3 ± 4.8 vs. 9.4 ± 3.5 mmHg, p = 0.31). The Trifecta valve is a valuable alternative to the Carpentier Edwards valve in terms of safety, hemodynamic performance, and mid-term durability. Smaller-sized valves provide additional clinical benefits, given their persistent hemodynamic advantages through mid-term follow-up.

Outcomes of Bioprosthetic Valve Fracture in Patients Undergoing Valve-in-Valve TAVR

BackgroundValve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) is increasingly used to treat degenerated surgical bioprostheses. Bioprosthetic valve fracture (BVF) has been shown to improve hemodynamic status in VIV TAVR in case series. However, the safety and efficacy of BVF are unknown. ObjectivesThe primary objective of this study was to assess the safety and efficacy of VIV TAVR using SAPIEN 3 and SAPIEN 3 Ultra valves with or without BVF using data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry. MethodsThe primary outcome was in-hospital mortality. Secondary outcomes included echocardiography-derived valve gradient and aortic valve area. Inverse probability of treatment weighting was used to adjust for baseline characteristics. ResultsA total of 2,975 patients underwent VIV TAVR from December 15, 2020, to March 31, 2022. BVF was attempted in 619 patients (21%). In adjusted analyses, attempted BVF was associated with higher in-hospital mortality (OR: 2.51; 95% CI: 1.30-4.84) and life-threatening bleeding (OR: 2.55; 95% CI: 1.44-4.50). At discharge, VIV TAVR with attempted BVF was associated with larger aortic valve area (1.6 cm2 vs 1.4 cm2; P < 0.01) and lower mean gradient (16.3 mm Hg vs 19.2 mm Hg; P < 0.01). When BVF was compared with no BVF according to timing (before vs after transcatheter heart valve implantation), BVF after transcatheter heart valve implantation was associated with improved hemodynamic status and similar mortality. ConclusionsBVF as an adjunct to VIV TAVR with the SAPIEN 3 and SAPIEN 3 Ultra valves is associated with a higher risk for in-hospital mortality and significant bleeding and modest improvements in echocardiography-derived hemodynamic status. The timing of BVF is an important determinant of safety and efficacy.

CRT-700.24 Comparison of a Novel Self-Expanding Transcatheter Heart Valve with Two Established Devices for Treatment of Degenerated Surgical Aortic Bioprostheses

CRT-700.24 Comparison of a Novel Self-Expanding Transcatheter Heart Valve with Two Established Devices for Treatment of Degenerated Surgical Aortic Bioprostheses

869 SUCCESSFUL TREATMENT OF COMBINED ANNULAR RUPTURE DURING TRANSCATHETER AORTIC VALVE IMPLANTATION: A CASE REPORT

Abstract Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of patients with severe, symptomatic aortic stenosis. Despite being less invasive than conventional open-chest surgery, TAVI remains associated with rare but serious complications such as vascular injury, stroke, coronary obstruction, cardiac perforation and annular rupture. We report a case of a combined annular rupture successful treated by emergent surgery. Case presentation: A low-risk (EuroSCORE:1.14%) 73-year-old male presenting with high-gradient, normal-flow severe aortic stenosis (AS) was referred to our centre. He had preserved left ventricular ejection fraction and heavily calcified aortic valve. The Heart Team recommended isolated surgical aortic valve replacement, but the patient refused this option. We decided to perform transfemoral-TAVI with a 26 mm Edwards valve which was deployed after predilatation with a 23 mm balloon. Immediately after valve deployment, the angiography revealed contrast leakage at the level of the Valsalva sinuses. The patient developed hypotension due to cardiac tamponade which was immediately managed with pericardial drainage. A bailout cardiac surgery was required to remove the TAVI prosthesis and the native aortic leaflets. A left ventricular outflow tract (LVOT) rupture was observed in addition to supra- annular and intra-annular injury. Repair of the left ventricle with a pericardial patch and implantation of a surgical bioprosthesis (Dafodil Meril 21 mm) were performed. No complications occurred post-operatively Annular rupture occurs in about 1% of all TAVI procedures and may involve the region of the aortic root and LVOT. According to the anatomical location of the injury, it can be classified into 4 types: intra-annular, sub-annular, supra-annular, and combined rupture. Annular rupture has been mainly observed after the use of balloon-expandable valves and only exceptionally after TAVI with self- expandable prosthesis. Nevertheless, the following anatomic characteristics are associated with an increased incidence of this catastrophic event: small aortic valve annulus (&amp;lt;20 mm), a narrow aortic root, heavy calcifications of aortic valve leaflets, annulus, LVOT and sinuses of Valsalva, bicuspid valve, short distance from a coronary artery to the annulus and LV hypertrophy. The voluminous amount of calcification located in the landing zone in addition to the force applied during the balloon expansion may be the main mechanism of this catastrophic complication. Clinical presentation is dramatic and emergent surgery can be the sole solution. Alternative bailout treatments, such as placing a second transcatheter valve to close the rupture have been occasionally reported. A precise preprocedural analysis of the device landing zone is mandatory. This includes determination of the size, morphology of all anatomical structures and a careful identification of possible factors for annular rupture. Moreover, in these cases, the availability of cardiac surgery onsite is pivotal to save patient's life. As more and younger patient will undergo TAVI in next years, our report highlightsthe need to optimize preprocedural planning and prosthesis selection. Improvements in devices, procedural techniques, and imaging tools may simplify TAVI and reduce possible complications.

BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs: design and rationale of the BASELINE trial

Surgical aortic valve bioprostheses may degenerate over time and require redo intervention. Transcatheter aortic valve replacement (TAVR) is a less invasive alternative to redo surgery. The BAlloon Expandable vs. SElf Expanding Transcatheter VaLve for Degenerated BioprosthesIs (BASELINE) trial was designed to compare the performance of the balloon-expandable SAPIEN-3 Ultra and the self-expanding EVOLUT PRO+ valve systems in symptomatic patients with a failing surgical bioprosthesis. The BASELINE trial is an investigator-initiated, non-funded, prospective, randomized, open-label, superiority trial enrolling a total of 440 patients in up to 50 sites in 12 countries in Europe and North-America. The primary endpoint is device success at 30-days defined by the Valve Academic Research Consortium-3 Criteria as the composite of technical success, freedom from mortality, freedom for surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication with an intended performance of the valve (mean gradient <20 mmHg and less than moderate aortic regurgitation). The co-primary endpoint at 1 year is defined as the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems. Independent Core Laboratories will conduct uniform analyses of echocardiography (pre-, post-, 1-year post-procedure), multi-sliced computed tomography (pre-, and if available post-procedure) and cine-fluoroscopy studies. The BASELINE trial is a head-to-head comparative trial investigating the 2 most used contemporary transcatheter heart valves for the treatment of a failing surgical aortic bioprosthesis. (ClinicalTrials.gov number NCT04843072).

Coronary access techniques following ACURATE neo2 implantation in surgical bioprosthesis.

Coronary access techniques following ACURATE neo2 implantation in surgical bioprosthesis.

Hemodynamic and Clinical Outcomes in Redo-Surgical Aortic Valve Replacement vs. Transcatheter Valve-in-Valve

BackgroundTranscatheter valve-in-valve replacement (ViV-TAVR) has emerged as an alternative to redo-surgical aortic valve replacement (Redo-SAVR) for the treatment of failed surgical aortic bioprostheses. However, the benefit of ViV-TAVR compared with Redo-SAVR remains debated with regard to short-term hemodynamic results and short- and long-term clinical outcomes. ObjectiveThis study aimed to compare short-term hemodynamic performance and long-term clinical outcomes of ViV-TAVR vs. Redo-SAVR in patients treated for surgical aortic bioprosthetic valve failure. MethodsWe retrospectively analyzed the data prospectively collected in 184 patients who underwent Redo-SAVR or ViV-TAVR. Transthoracic echocardiography was performed before and after the procedure and analyzed in an echocardiography core laboratory using the new Valve Academic Research Consortium-3 criteria. An inverse probability of treatment weighting was used to compare the outcomes between both procedures. ResultsViV-TAVR showed lower rate of intended hemodynamic performance (39.2% vs. 67.7%, p < 0.001) at 30 days, which was essentially driven by a higher rate (56.2% vs. 28.8%, p = 0.001) of high residual gradient (mean transvalvular gradient ≥20 mm Hg). Despite a trend for higher 30-day mortality in the Redo-SAVR vs. ViV-TAVR group (8.7% vs. 2.5%, odds ratio [95% CI]: 3.70 [0.77-17.6]; p = 0.10), the long-term mortality was significantly lower (24.2% vs. 50.1% at 8 years; hazard ratio [95% CI]: 0.48 [0.26-0.91]; p = 0.03) in the Redo-SAVR group. After inverse probability of treatment weighting analysis, Redo-SAVR remained significantly associated with reduced long-term mortality compared with ViV-TAVR (hazard ratio [95% CI]: 0.32 [0.22-0.46]; p < 0.001). ConclusionsViV-TAVR was associated with a lower rate of intended hemodynamic performance and numerically lower mortality at 30 days but higher rates of long-term mortality compared with Redo-SAVR.

Retracted: Oral Presentation No. 91 Valve-in-valve TAVI for treatment of degenerated surgical aortic bioprosthesis

This abstract has been withdrawn. Please see: https://doi.org/10.1093/cvr/cvac183

Temporal changes in aortic valve replacement according to age in Denmark: nationwide data from 2008 to 2020

Abstract Background Since the introduction of transcatheter aortic valve implantation (TAVI), the management of symptomatic severe aortic stenosis has changed. Recent published European guidelines (2021) favours TAVI over surgical aortic valve replacements (SAVR) in patients with older age (≥75 years of age) or patients with high surgical risk. The study of nationwide practice patterns for AVR is important and renders the possibility to evaluate whether clinical practice differs from current guidelines. Purpose To evaluate temporal changes in use of isolated aortic valve replacement (AVR) procedures according to age in the era of TAVI in Denmark. Methods We identified all first-time aortic valve replacement procedures (TAVI or SAVR) from 2008 until the end of 2020 through administrative registries in Denmark. Patients with no prior diagnosis of aortic stenosis at time of AVR were excluded. Patients with prior AVR or valve repair were excluded. SAVR was divided according to type of prostheses: surgical bioprostheses and mechanical prostheses. To evaluate changes according to age the study cohort was divided into two age groups: &amp;lt;75 and ≥75 years of age. Results Between 2008 and 2020, 12,313 first-time isolated AVR procedures were performed in Denmark. Volume of isolated AVR increased from 621 to 1256 procedures per year (ptrend &amp;lt;0.001). Isolated SAVR was performed in 6,548 patients (53.2%) and TAVI in 5,765 patients (46.8%). Median age of TAVI patients was 81.4 [76.9–85.2] years of age compared to 73.1 [68.0-≥77.7] in patients receiving surgical bioprostheses and TAVI patients had a higher degree of comorbidity (TAVI: 70% of patients with Charlson comorbidity score ≥1, surgical bioprostheses: 50% of patients with Charlson comorbidty score ≥1). TAVI increased during study period compared to isolated SAVR, where a decreasing trend was observed from 2014 and onwards. In &amp;lt;75-year-old patients, volume of TAVI significantly increased during study period (ptrend&amp;lt;0.001), whereas volume of surgical bioprostheses remained stable. Volume of mechanical prostheses decreased over time (ptrend &amp;lt;0.001) TAVI increased in ≥75-year-old patients (ptrend &amp;lt;0.001) and TAVI accounted for 91.5% of all isolated AVR procedures in 2020. In contrast, volume of isolated SAVR declined driven by a decreasing use of surgical bioprostheses (ptrend=0.001). (Figure 1). Conclusions Volume of isolated aortic valve replacement (AVR) doubled from 2008 and 2020. The increase in isolated AVR was driven by transcatheter aortic valve implantation (TAVI). TAVI has become the predominant choice of isolated AVR in management of aortic stenosis and our results suggest that real-world practise patterns are in line with current guideline recommendations. Funding Acknowledgement Type of funding sources: None.

Bioprosthetic valve fracture during valve-in-valve transcatheter aortic valve replacement: multicenter propensity matched analysis

Abstract Background Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) can be completed by bioprosthetic valve fracture (BVF) to reduce final transvalvular gradients. The aim was to compare outcomes in ViV-TAVI patients with versus without BVF. Methods Consecutive patients undergoing ViV-TAVI procedure in four international centers were included, from 2010 to 2021. We used a 1:2 propensity score-matching method to compare postprocedural hemodynamic, complications, and long-term outcomes. Patients were matched for baseline characteristics, time since prior surgery, and characteristics of surgical bioprothesis (type and size). Results A total of 390 patients were analyzed, including 40 BVF. Propensity matching 1:2 yielded 38 patients in BVF group and 76 patients in no-BVF group. There was no difference in procedural complications rate and in-hospital deaths (5.1%) between the two groups. Post-procedural hemodynamic parameters significantly improved using BVF: aortic valve area (1.4 cm2 [IQR: 1.23 to 2.3] vs. 1.3 cm2 [IQR: 1.05 to 1.61], p=0.008), mean aortic gradient (12mmHg [IQR: 7.5 to 16.5] vs. 17mmHg [IQR: 11 to 22], p=0.008) and peak velocity (2.2m/s [IQR: 1.8 to 2.7] vs. 2.6m/s [IQR: 2.2 to 3.1], p=0.027). BVF had an additional benefit in the smallest surgical valve (≤21 mm). The use of BVF was independently associated with improved hemodynamic parameters. Overall survival in the matched cohort was 87.8±3.7% at 2-year follow-up, without difference between groups (87.5±6.9% in the BVF group vs. 88.4±4.2% in the no-BVF group, p=0.85). Conclusion Compared to ViV-TAVI alone, BVF was safe and improved immediate hemodynamic and long-term outcomes, especially in patients with small surgical aortic bioprosthesis. Funding Acknowledgement Type of funding sources: None.

Early pacemaker insertion after aortic valve replacement with an Edwards Intuity sutureless valve

BackgroundPostoperative conduction disorders are serious adverse events in patients undergoing aortic valve replacement, and may prolong the duration of hospitalization and require pacemaker insertion. AimOur aim was to evaluate the rate of pacemaker insertion after implantation of an Edwards Intuity sutureless aortic valve (Edwards Lifesciences, Irvine, CA, USA) compared with a standard surgical bioprosthesis. MethodsThis retrospective single-centre study included patients who underwent aortic valve replacement with an Intuity sutureless aortic valve or a standard bioprosthetic valve between 4 June 2014 and 27 June 2016. The main outcome criterion was the rate of postoperative pacemaker insertion. Secondary outcome criteria included the rate of new conduction disorders, the rate of atrial arrhythmia or paroxysmal conduction disorders, mortality and duration of hospital stay. ResultsNinety-three patients received an Intuity sutureless aortic valve (median age 76 years, interquartile range 71–80 years), and 176 were implanted with a standard biological aortic valve (median age 73 years, interquartile range 68–79 years; P=0.007). The rate of postoperative pacemaker insertion, after adjustment, was 22.44% in the Intuity group and 5.66% in the standard aortic valve group (P=0.030). The main indications for postoperative pacemaker insertion were complete atrioventricular block and left bundle branch block with prolongation of the H-V interval. The rate of new postoperative left bundle branch block conduction disorders was significantly higher in patients implanted with an Intuity valve (odds ratio 5.28, 95% confidence interval 1.59 to 23.05; P=0.012). ConclusionHigher rates of pacemaker insertion and new conduction disorders were observed in patients implanted with an Intuity sutureless bioprosthesis compared with those who received a standard surgical aortic valve.