Surgical Bioprosthetic Valves Research Articles

Left ventricular guidewire pacing during transcatheter aortic valve replacement

Objective: To investigate the safety and efficacy of left ventricular guidewire pacing during transcatheter aortic valve replacement (TAVR). Methods: This is a retrospective study. Thirteen patients, who underwent TAVR with left ventricular guidewire pacing from October 2019 to December 2019 in Fuwai Hospital, were included. Clinical data and operational procedure data of the patients were collected. Changes in blood pressure and electrocardiogram were observed during operations. Ascending aorta angiography was performed to evaluate the regurgitation of aortic valve after valve implantion. The incidence of major adverse cardiac events during hospitalization and at 3-months after discharge was recorded. Results: There were 7 male and 6 female patients in this cohort,and age was (73.8±8.3) years old. Among the 13 patients, 9 were tricuspid aortic valves, 3 were bicuspid aortic valves, and 1 was degenerated bioprosthetic surgical aortic valve. TAVR were successfully performed in all of the 13 cases using pacing through the left ventricular guidewire. During balloon dilation, the blood pressure decreased to below 60 mmHg (1 mmHg=0.133 kPa) after 180 beats/min pacing, and the valve release process was smooth and the position was stable. The results of aortography showed that there was no regurgitation in 7 cases, mild regurgitation in 5 cases and moderate regurgitation in 1 case. Three patients required temporary pacing during the procedure due to complete heart block, among whom 1 patient was implanted with permanent pacemaker during hospitalization, and the other 2 patients recovered within 24 hours after operation. In another case, there was no significant change of electrocardiogram during the operation, and complete heart block occurred 10 days after the operation, and treated with permanent pacemaker. The other 10 patients began to carry out bedside activities and rehabilitation training 24 hours after operation. There was no death, myocardial infarction, stroke and other major adverse cardiac events during hospitalization and at 3-month follow-up after discharge. Conclusion: Left ventricular guidewire pacing is a safe and effective strategy for TAVR.

1-Year Outcomes following Bioprosthetic Valve Fracture to Facilitate Valve-in-Valve Transcatheter Aortic Valve Replacement

ABSTRACT Background: Bioprosthetic valve fracture (BVF) improves the hemodynamic results of valve-in-valve transcatheter aortic valve replacement (VIV TAVR) by facilitating optimal expansion of the transcatheter heart valve (THV). Long-term outcomes following BVF are unknown. Methods: Consecutive cases of VIV TAVR and BVF (n = 139) performed at 11 sites were analyzed retrospectively. Hemodynamic measurements and aortic valve area (AVA) were assessed during the procedure and by echocardiography at 30-day and 1-year follow-up. Results: VIV TAVR and BVF resulted in significant improvements in mean valve gradient (42.3 ± 17.1 vs. 9.4 ± 5.8 mmHg, p < 0.001) and AVA (0.8 ± 0.4 vs. 1.8 ± 0.7 cm2, p < 0.001) compared with baseline. Mortality was 2.3% at 30 days and 8.7% at 1-year. In adjusted models, mean valve gradient was higher (+5.1 [3.7, 6.5] mmHg, p < 0.001) and AVA was lower (−0.3 [−0.4, −0.2] cm2, p < 0.001) at 1 month as compared to post-procedure. Between 30 days and 1 year, no significant changes in mean valve gradient (+1.4 [−0.5, 3.4] mmHg, p = 0.15) or AVA (−0.1 [−0.3, 0.03] cm2, p = 0.11) were observed. In a multivariable analysis, use of a CoreValve (compared with a SAPIEN) THV was an independent predictor of a lower mean valve gradient at 1 year (−6.0 mmHg, p = 0.01). Conclusion: Survival is excellent following VIV TAVR and BVF and valve hemodynamics are stable between 30-day and 1-year follow-up. CoreValve use is a predictor of better hemodynamic results following VIV TAVR and BVF. Abbreviations: VIV TAVR: valve-in-valve transcatheter aortic valve replacement; THV: transcatheter heart valve; BSV: bioprosthetic surgical valve; PPM: patient prosthesis mismatch; BVF: bioprosthetic valve fracture; IQR: interquartile range; LVEF: left ventricular ejection fraction; AVA: aortic valve area; STS PROM: Society of Thoracic Surgeons predicted risk of mortality

Late incidence and recurrence of new-onset atrial fibrillation after isolated surgical aortic valve replacement

ObjectivesAtrial fibrillation (AF) is a common complication after cardiac surgery. More knowledge is needed about long-term AF recurrence and adverse outcomes related to new-onset AF (NOAF) during the index hospitalization. MethodsA total of 1073 patients underwent isolated surgical aortic valve replacement at the 4 participating hospitals (2002-2014). After the exclusion of patients with a history of any preoperative AF, the final study population included 529 patients in the bioprosthetic and 253 patients in the mechanical valve prosthesis cohort. Median follow-up time was 5.4 (interquartile range, 3.4-8.2) years in the combined cohort. ResultsAltogether 333 (42.6%) patients had in-hospital NOAF and 250 (32.0%) AF after hospital discharge. In the mechanical cohort, 64 (25.3%) experienced in-hospital NOAF and 74 (29.2%) AF after hospital discharge, whereas in the bioprosthetic cohort, 269 (50.9%) patients had in-hospital NOAF and 176 (33.3%) AF after hospital discharge. Patients with NOAF during the index hospital stay had a multifold risk of AF after hospital discharge in the combined cohort (hazard ratio [HR], 3.68; 95% confidence interval [CI], 2.82-4.81; P < .0001) as well as in both cohorts separately (bioprosthetic: HR, 4.35; 95% CI, 3.05-6.22; P < .001; mechanical: HR, 2.54; 95% CI, 1.59-4.03; P < .001). Patients with an in-hospital NOAF also had a significantly higher adjusted risk of death during the follow-up in the mechanical (HR, 2.05; 95% CI, 1.10-3.82; P = .025) and bioprosthetic (HR, 1.63; 95% CI, 1.17-2.28; P = .004) valve prosthesis cohorts. ConclusionsNOAF during the index hospitalization is associated with a 2- to 4-fold risk of later AF and 1.6- to 2.0-fold risk of all-cause mortality after mechanical and bioprosthetic surgical aortic valve replacement.

Off-label Use of Direct Oral Anticoagulants in Patients Receiving Surgical Mechanical and Bioprosthetic Heart Valves

This cohort study assesses direct oral anticoagulant use in patients with surgical prosthetic heart valves in the United States and evaluates differences in preoperative and postoperative profiles in patients discharged while receiving direct oral anticoagulant vs warfarin.

Meta-Analysis of Stroke and Mortality Rates in Patients Undergoing Valve-in-Valve Transcatheter Aortic Valve Replacement.

BackgroundDuring the past decade, the use of transcatheter aortic valve replacement (TAVR) was extended beyond treatment‐naïve patients and implemented for treatment of degenerated surgical bioprosthetic valves. Selection criteria for either valve‐in‐valve (viv) TAVR or redo surgical aortic valve replacement are not well established, and decision making on the operative approach still remains challenging for the interdisciplinary heart team.Methods and ResultsThis review was intended to analyze all studies on viv‐TAVR focusing on short‐ and mid‐term stroke and mortality rates compared with redo surgical aortic valve replacement or native TAVR procedures. A structured literature search and review process led to 1667 potentially relevant studies on July 1, 2020. Finally, 23 studies fulfilled the inclusion criteria for qualitative analysis. All references were case series either with or without propensity score matching and registry analyses. Quantitative synthesis of data from 8509 patients revealed that viv‐TAVR is associated with mean 30‐day stroke and mortality rates of 2.2% and 4.2%, respectively. Pooled data analysis showed no significant differences in 30‐day stroke rate, 30‐day mortality, and 1‐year mortality between viv‐TAVR and comparator treatment (native TAVR [n=11 804 patients] or redo surgical aortic valve replacement [n=498 patients]).ConclusionsThis review is the first one comparing the risk for stroke and mortality rates in viv‐TAVR procedures with native TAVR approach and contributes substantial data for the clinical routine. Moreover, this systematic review is the most comprehensive analysis on ischemic cerebrovascular events and early mortality in patients undergoing viv‐TAVR. In this era with increasing numbers of bioprosthetic valves used in younger patients, viv‐TAVR is a suitable option for the treatment of degenerated bioprostheses.

Outcomes of Surgical Mitral and Aortic Valve Replacements Among Kidney Transplant Candidates: Implications for Valve Selection.

BackgroundLimited literature exists that evaluated outcomes of kidney transplant–eligible patients who are having dialysis and who are undergoing valve replacement. Our main objective in this study was to compare mortality, reoperation, and bleeding episodes between bioprosthetic and mechanical valve procedures among kidney transplant–eligible patients who are having dialysis.Methods and ResultsWe studied 887 and 1925 dialysis patients from the United States Renal Data System, who underwent mitral valve replacement and aortic valve replacement (AVR) after being waitlisted for a kidney transplant (2000–2015), respectively. Time to death, time to reoperation, and time to bleeding requiring hospitalizations were compared separately for AVR and mitral valve replacement. Kaplan–Meier survival curves, Cox proportional hazards model for time to death, accelerated time to event model for time to reoperation, and counting process model for time to recurrent bleeding were used. There were no differences in mortality (hazard ratio [HR], 0.92; 95% CI, 0.77–1.09) or risk of reoperation or risk of significant bleeding events between bioprosthetic and mechanical mitral valve replacement. However, mechanical AVR was associated with a modestly significant less hazard of death (HR, 0.83; 95% CI, 0.74–0.94) compared with bioprosthetic AVR. There were no differences in time to reoperation, or time to significant bleeding events between bioprosthetic and mechanical AVR.ConclusionsFor kidney transplant waitlisted patients who are on dialysis and who are undergoing surgical valve replacement, bioprosthetic and mechanical valves have comparable survival, reoperation rates, and bleeding episodes requiring hospitalizations at both mitral and aortic locations. These findings emphasize that an individualized informed decision is recommended when choosing the type of valve for this special group of patients having dialysis.

Efficacy and safety of edoxaban in patients early after surgical bioprosthetic valve implantation or valve repair: A randomized clinical trial

ObjectiveEarly warfarin anticoagulation is recommended in patients undergoing surgical bioprosthetic valve implantation or valve repair. It is unclear whether non-vitamin K antagonist oral anticoagulants can be a full alternative to warfarin. This study aimed to compare efficacy and safety of edoxaban with warfarin in patients early after surgical bioprosthetic valve implantation or valve repair. MethodsThe Explore the Efficacy and Safety of Edoxaban in Patients after Heart Valve Repair or Bioprosthetic Valve Replacement study was a prospective, randomized (1:1), open-label, clinical trial conducted from December 2017 to September 2019. Patients were randomly assigned to receive edoxaban (60 mg or 30 mg once daily) or warfarin for the first 3 months after surgical bioprosthetic valve implantation or valve repair. The primary efficacy outcome was a composite of death, clinical thromboembolic events, or asymptomatic intracardiac thrombosis. The primary safety outcome was the occurrence of major bleeding. ResultsOf 220 participants, 218 (109 per group) were included in the modified intention-to-treat analysis. The primary efficacy outcome occurred in 4 patients (3.7%) taking warfarin and none taking edoxaban (risk difference, −0.0367; 95% confidence interval, –0.0720 to –0.0014; P < .001 for noninferiority). The primary safety outcome occurred in 1 patient (0.9%) taking warfarin and 3 patients (2.8%) taking edoxaban (risk difference, 0.0183; 95% confidence interval, –0.0172 to 0.0539; P = .013 for noninferiority). ConclusionsEdoxaban is noninferior to warfarin for preventing thromboembolism and is potentially comparable for risk of major bleeding during the first 3 months after surgical bioprosthetic valve implantation or valve repair.

18F-Sodium fluoride PET/CT detects transcatheter aortic valve degeneration

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): This work was supported by the British Heart Foundation, London, United Kingdom Background Early detection of transcatheter aortic valve implantation (TAVI) degeneration is challenging and only feasible when advanced haemodynamic valve dysfunction is apparent. Purpose We tested whether 18F-sodium fluoride (18F-NaF) positron emission tomography and computed tomography (PET/CT) could detect structural TAVI degeneration and haemodynamic valve dysfunction. Methods After TAVI implantation, patients underwent baseline echocardiography, CT angiography and 18F-NaF PET/CT (Figure). We assessed for morphological changes, stenosis or regurgitation on Doppler echocardiography, CT (hypoattenuated leaflet thickening [HALT] or spotty calcification) and PET (18F-NaF uptake; maximum target-to-background ratio, TBRmax). We categorised structural valve degeneration (SVD) according to the standardised definition for surgical and transcatheter bioprosthetic valves, as proposed in a recent consensus statement. Results We recruited 47 patients (81 ± 6 years old, 79% male) 1 month (n = 9), 2 years (n = 22) or 5 years (n = 16) after TAVI: 25 (53%) had received a balloon expanded bioprosthesis and 22 (47%) a self-expanding valve. There was moderate valve dysfunction on Doppler echocardiography in 3 (6%) patients, HALT on CT in 6 (13%) patients, spotty calcification in one patient and 18F-NaF uptake in 7 patients (15%) (TBRmax range: 1.59-5.88); all enrolled 5 years post-TAVI. All patients with increased 18F-NaF uptake (TBRmax ≥1.59) demonstrated either SVD without haemodynamic valve dysfunction (stage 1, n = 4) or structural valve dysfunction with moderate valve dysfunction and mean transprosthetic pressure gradients &amp;gt;20 mmHg (stage 2, n = 3). In patients without increased 18F-NaF uptake there was no evidence of structural valve degeneration (n = 40). Within the increased 18F-NaF uptake (n = 7) group, patients with stage 2 SVD (n = 3) demonstrated higher uptake compared to patients with stage 1 SVD (TBRmax 4.3 [3.02-5.88] versus 1.8 [1.59-2.28]). Patients with stage 2 SVD (n = 3) had over 3 times higher TBRmax than those without SVD (n = 40) (4.30 [3.02, 5.88] versus 1.31 [1.21, 1.46]; p &amp;lt; 0.001); Figure). Conclusion 18F-NaF PET/CT detects patients with SVD and potentially identifies those at risk of valve failure. Abstract Figure.

Impact of BASILICA on the thrombogenicity potential of valve-in-valve implantations

Subclinical leaflet thrombosis is becoming a major concern in valve-in-valve procedures, whereby a transcatheter aortic valve device is deployed inside a failed bioprosthetic surgical valve. Blood flow stagnation and prolonged residence times in the neo-sinuses have been suggested as possible explanations for leaflet thrombosis. The BASILICA technique, which was originally developed to treat coronary flow obstruction, has also been proposed as an alternative to reduce the risk of thrombus formation. The aim of this study is to understand the impact of BASILICA on the valve-in-valve thrombogenicity using computational fluid dynamics simulations. To this end, two Eulerian and two Lagrangian approaches were employed to estimate near-wall stagnation measures in eight valve-in-valve models. The models included an intact or lacerated Sorin Mitroflow surgical valve, and either a SAPIEN or Evolut transcatheter aortic valve device. The Lagrangian approaches predicted a high number of particles and vortices concentration in the proximal areas of the neo-sinuses, while the Eulerian approaches did so in the distal areas. As a consequence, this study demonstrated that Lagrangian approaches are better predictors of subclinical leaflet thrombosis, since they match experimental and clinical findings. Additionally, the SAPIEN valve possess a higher risk for developing leaflet thrombosis, and two lacerations are shown to provide the best results in terms of development of vortices and accumulation of particles within the neo-sinuses. This study highlights the potential of computational modeling in aiding clinicians in their decision-making in valve-in-valve and BASILICA procedures.

Bioengineered percutaneous heart valves for transcatheter aortic valve replacement: a comparative evaluation of decellularised bovine and porcine pericardia

Glutaraldehyde-treated, surgical bioprosthetic heart valves undergo structural degeneration within 10–15 years of implantation. Analogous preliminary results were disclosed for percutaneous heart valves (PHVs) realized with similarly-treated tissues. To improve long-term performance, decellularised scaffolds can be proposed as alternative fabricating biomaterials. The aim of this study was to evaluate whether bovine and porcine decellularised pericardia could be utilised to manufacture bioengineered percutaneous heart valves (bioPHVs) with adequate hydrodynamic performance and leaflet resistance to crimping damage.BioPHVs were fabricated by mounting acellular pericardia onto commercial stents. Independently from the pericardial species used for valve fabrication, bioPHVs satisfied the minimum hydrodynamic performance criteria set by ISO 5840-3 standards and were able to withstand a large spectrum of cardiac output conditions, also during extreme backpressure, without severe regurgitation, especially in the case of the porcine group. No macroscopic or microscopic leaflet damage was detected following bioPHV crimping.Bovine and porcine decellularized pericardia are both suitable alternatives to glutaraldehyde-treated tissues. Between the two types of pericardial species tested, the porcine tissue scaffold might be preferable to fabricate advanced PHV replacements for long-term performance. Condensed abstractCurrent percutaneous heart valve replacements are formulated with glutaraldehyde-treated animal tissues, prone to structural degeneration. In order to improve long-term performance, bovine and porcine decellularised pericardia were utilised to manufacture bioengineered replacements, which demonstrated adequate hydrodynamic behaviour and resistance to crimping without leaflet architectural alteration.

Endovascular snare technique to facilitate delivery of self-expanding valve during transcatheter aortic valve-in-valve replacement in angulated aortas: A case series.

Transcatheter aortic valve-in-valve replacement (ViV) has been widely accepted as a less invasive alternative to treat failed aortic surgical or transcatheter bioprosthetic valves. Angulated aortas present an additional challenge, particularly when using self-expanding transcatheter heart valves (SE-THV). Two patients with failed surgical bioprosthetic aortic valves and one patient with a failed transcatheter bioprosthetic aortic valve underwent transcatheter aortic ViV using SE-THV. All were deemed high-risk for surgical aortic valve replacement by a heart team. All three patients had initial failed SE-THV delivery using a conventional approach with subsequent successful delivery using the endovascular snare technique. In Cases 1 and 2, the SE-THV was biased towards the greater curve of the angulated aorta and behind the outer frame of the bioprosthetic valve frame. An endovascular snare was deployed through a secondary left femoral artery access, and the valve delivery system was advanced through the snare in the ascending aorta. The snare was tightened around the SE-THV capsule proximal to the hat-marker, allowing deflection of the SE-THV and successful delivery. In Case 3, the SE-THV interacted with the tall frame of a failed SE-THV. A snare via the left femoral artery was deployed in the descending artery. The SE-THV was advanced through the snare, and both the snare and SE-THV were advanced together to the ascending aorta where the SE-THV was deflected and successfully delivered. The endovascular snare technique is a feasible option for successful delivery of SE-THV during transcatheter aortic ViV in failed transcatheter or surgical bioprosthetic valves in angulated aortas.

Assessment of long-term structural deterioration of transcatheter aortic bioprosthetic valves

The durability of transcatheter aortic bioprosthetic valves is a crucial issue in the context of extension of indications in younger and lower-risk patients, but data are scarce, especially beyond 5 years of follow-up. The aim of this study was to evaluate the incidence of structural valve degeneration (SVD). Demographic, procedural, and in-hospital outcome data on patients who underwent transcatheter aortic valve implantation (TAVI) from 2002 to 2020 were obtained from our prospective institutional database. Patients in whom echocardiographic data were available both at baseline and follow-up post-TAVI were included. Clinical and echocardiographic follow-up were performed on site annually. Hemodynamic SVD was determined according to European task force committee guidelines. A total of 1824 patients (83.6 ± 6.8 years of age; 53% female) with paired post-procedure and late echocardiographic follow-up (median 1.9 years, max 10.9 years) were included. Among them, 223 (12.3%) patients have a follow-up of more than 5 years. A self-expandable valve was used in 160 (8.8%) patients while the remaining patients were treated with, a balloon-expandable valve (91.2%). Mean aortic gradient and effective aortic valve area remained unchanged during follow-up. SVD occurred in 16 (0.9%) patients. SVD was moderate in 8 (0.4%) patients and severe in 8 (0.4%) patients. Four (0.4%) patients required redo-TAVI for severe SVD. Our data do not demonstrate any alarm signal on transcatheter aortic valve durability. Careful prospective assessment in younger and lower risk patients and comparison with surgical bioprosthetic valves are required to further assess long-term durability of transcatheter valves.

Mechanism of Failure of Surgical Aortic Bioprosthetic Valves Undergoing Valve-in-Valve TAVI

Mechanism of Failure of Surgical Aortic Bioprosthetic Valves Undergoing Valve-in-Valve TAVI

Transcatheter Aortic Valve Implantation for Failed Surgical Aortic Bioprostheses Using a Self-Expanding Device (from the Prospective VIVA Post Market Study)

Patients with symptomatic aortic stenosis are often treated with a surgical valve replacement. Surgical bioprosthetic valves degenerate over time and therefore may necessitate a redo surgery. This analysis reports the 2-year clinical outcomes of the Valve-in-Valve study, which evaluated transcatheter aortic valve implantation using the CoreValve and Evolut R devices in patients with degenerated surgical aortic bioprostheses at high risk for surgery. The prospective Valve-in-Valve study enrolled 202 eligible patients with failing surgical aortic bioprostheses due to stenosis, regurgitation, or a combination of both. The Evolut R bioprosthesis was used in 90.5% of valve-in-valve transcatheter aortic valve implantation cases. Two-year all-cause and cardiovascular mortality rates were 16.5% and 11.1%, respectively. Other clinical events included stroke (7.9%), disabling stroke (1.7%), and new pacemaker implantation (10.1%). The 2-year all-cause mortality rate was significantly higher in patients with discharge mean gradients ≥20 mmHg vs. those with lower mean gradients (21.0% vs 7.6%, p = 0.025). Discharge mean gradients ≥20 mm Hg were associated with smaller surgical bioprostheses (OR, 7.2 [95% CI 2.3 to 22.1]. In patients with failing surgical aortic bioprostheses, valve-in-valve treatment using a supra-annular self-expanding bioprosthesis provides significant functional improvements with acceptable rates of complications, especially if a postprocedural mean gradient of <20 mmHg can be achieved.

Clinical outcomes of transcatheter aortic valve implantation in failed bioprosthetic surgical valves vs. native aortic stenosis: insights from a meta-analysis.

There is no meta-analysis comparing clinical outcomes between valve-in-valve transcatheter aortic valve implantation for failed surgical bioprosthetic valves (ViV-TAVI) and native valve TAVI for aortic stenosis (NV-TAVI). We aimed to investigate clinical outcomes between ViV-TAVI and NV-TAVI using a meta-analysis. EMBASE and MEDLINE were searched through April 2020 to investigate the comparative outcomes between ViV-TAVI and NV-TAVI. The main outcomes were short-term (30-day/in-hospital) mortality, pacemaker implantation (PMI), life threatening and/or major bleeding, stroke, and coronary obstruction, and long-term (1-year) mortality and stroke. Our search identified 5 observational studies enrolling a total of 8428 patients (1442 patients with ViV-TAVI and 6986 with NV-TAVI). ViV-TAVI was associated with significantly lower rates of short-term mortality, PMI, and life threatening and/or major bleeding, compared with NV-TAVI (relative risk [RR] [95% CI] 0.54 [0.34-0.84], P = 0.007; 0.25 [0.19-0.35], P < 0.0001; 0.64 [0.46-0.89], P = 0.008, respectively). There were no significant differences in rates of short-term stroke and coronary obstruction between ViV-TAVI and NV-TAVI (RR [95% CI] 0.59 [0.35-1.01], P = 0.06; 1.86 [0.78-4.41], P = 0.16, respectively). ViV-TAVI was also associated with a significantly lower rate of 1-year mortality compared with NV-TAVI (RR [95% CI] 0.64 [0.51-0.81], P = 0.0002), whereas there was no significant difference in long-term stroke (RR [95% CI] 0.71 [0.45-1.12], P = 0.51). ViV-TAVI was associated with significantly lower rates of short-term mortality, PMI, and life threatening and/or major bleeding, and long-term mortality, without increased risks of stroke and coronary obstruction, compared with NV-TAVI.

Assessment of long-term structural deterioration of transcatheter aortic bioprosthetic valves

Abstract Background The durability of transcatheter aortic bioprosthetic valves is a crucial issue in the context of extension of indications in younger and lower-risk patients, but data are scarce, especially beyond 5 years of follow-up. This study sought to evaluate the incidence of structural valve degeneration (SVD) 5 to 10 years post-procedure. Methods Demographic, procedural, and in-hospital outcome data on patients who underwent transcatheter aortic valve implantation (TAVI) from 2002 to 2014 were obtained from our prospective institutional database. Patients in whom echocardiographic data were available both at baseline and 5 years post-TAVI were included. Clinical and echocardiographic follow-up were performed on site annually. Hemodynamic SVD was determined according to European task force committee guidelines. Results A total of 208 patients (82.5±7.6 years of age; 53% female) with paired post-procedure and late echocardiographic follow-up (median 5.3 years, range 5 to 11.4 years) were included. Eleven (5.3%) patients were treated with a self-expandable valve and 197 (94.7%) patients with a balloon-expandable valve. Mean aortic valve gradient and effective aortic valve area remained unchanged during follow-up. There were 2 cases (1.0%) of severe SVD 6 and 7 years after implantation requiring redo-TAVI. There were 4 cases (1.9%) of moderate SVD (mean 6.0 years post-implantation; range 5 to 7 years). Conclusions Our data do not demonstrate any alarm on transcatheter aortic valve durability. Careful prospective assessment in younger and lower risk patients and comparison with surgical bioprosthetic valves are required to further assess long-term durability of transcatheter valves. Funding Acknowledgement Type of funding source: None

Risk of Coronary Obstruction Due to Sinus Sequestration in Redo Transcatheter Aortic Valve Replacement.

The aim of this study was to evaluate the risk of coronary obstruction due to sinus sequestration in redo transcatheter aortic valve replacement (TAVR) using post-TAVR computed tomography (CT). Little information is available regarding the risk of coronary obstruction due to sinus sequestration in redo TAVR inside a previously implanted TAV. Post-TAVR CT of 66 patients who received an Evolut R or Evolut PRO and 345 patients who received a SAPIEN 3 were analyzed. Redo TAVR was considered at risk of coronary obstruction due to sinus sequestration if: 1) the prior TAV commissure level was above sinotubular junction (STJ); and 2) the distance between TAV and STJ was<2.0mm in each coronary sinus. In total, 45.5% in the Evolut R/Evolut PRO group and 2.0% in the SAPIEN 3 group had CT-identified risk of sinus sequestration at 1 or both coronary arteries (p<0.001). CT-identified risk of sinus sequestration was observed in 39.4% for the left coronary artery and 24.2% for the right coronary artery in the Evolut R/Evolut PRO group, while those percentages were 2.0% for the left coronary artery and 0.6% for the right coronary artery in the SAPIEN 3 group. In a coronary-level analysis, overlaps between the first TAV commissural posts and coronary ostium were observed in 45.2% in the Evolut R/Evolut PRO group and 11.1% in in the SAPIEN 3 group among coronary arteries at CT-identified risk of sinus sequestration. The risk of sinus sequestration in redo TAVR should be carefully screened by CT, especially in patients with low STJ height. TAV with low commissure height that was designed to achieve commissure-to-commissure alignment with the native aortic valves may be preferable to avoid the risk of coronary obstruction due to sinus sequestration and allow for a preventive leaflet laceration procedure in future redo TAVR. (Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Thrombosis and Its TrEatment With Anticoagulation [RESOLVE]; NCT02318342).

Structural Deterioration of Transcatheter Versus Surgical Aortic Valve Bioprostheses in the PARTNER-2 Trial

BackgroundIt is unknown whether transcatheter valves will have similar durability as surgical bioprosthetic valves. Definitions of structural valve deterioration (SVD), based on valve related reintervention or death, underestimate the incidence of SVD. ObjectivesThis study sought to determine and compare the 5-year incidence of SVD, using new standardized definitions based on echocardiographic follow-up of valve function, in intermediate-risk patients with severe aortic stenosis given transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) in the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial and registry. MethodsIn the PARTNER 2A trial, patients were randomly assigned to receive either TAVR with the SAPIEN XT or SAVR, whereas in the SAPIEN 3 registry, patients were assigned to TAVR with the SAPIEN 3. The primary endpoint was the incidence of SVD, that is, the composite of SVD-related hemodynamic valve deterioration during echocardiographic follow-up and/or SVD-related bioprosthetic valve failure (BVF) at 5 years. ResultsCompared with SAVR, the SAPIEN-XT TAVR cohort had a significantly higher 5-year exposure adjusted incidence rates (per 100 patient-years) of SVD (1.61 ± 0.24% vs. 0.63 ± 0.16%), SVD-related BVF (0.58 ± 0.14% vs. 0.12 ± 0.07%), and all-cause (structural or nonstructural) BVF (0.81 ± 0.16% vs. 0.27 ± 0.10%) (p ≤ 0.01 for all). The 5-year rates of SVD (0.68 ± 0.18% vs. 0.60 ± 0.17%; p = 0.71), SVD-related BVF (0.29 ± 0.12% vs. 0.14 ± 0.08%; p = 0.25), and all-cause BVF (0.60 ± 0.15% vs. 0.32 ± 0.11%; p = 0.32) in SAPIEN 3 TAVR were not significantly different to a propensity score matched SAVR cohort. The 5-year rates of SVD and SVD-related BVF were significantly lower in SAPIEN 3 versus SAPIEN XT TAVR matched cohorts. ConclusionsCompared with SAVR, the second-generation SAPIEN XT balloon-expandable valve has a higher 5-year rate of SVD, whereas the third-generation SAPIEN 3 has a rate of SVD that was not different from SAVR. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII A [PARTNERII A]; NCT01314313; The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - PARTNERII - S3 Intermediate [PARTNERII S3i]; NCT03222128)

Outcomes of Sutureless/Rapid Deployment Valves Compared to Traditional Bioprosthetic Aortic Valves

Sutureless/rapid-deployment (SRD) valves for aortic valve replacement (AVR) are new surgical bioprosthetic valves that allow for expedited implantation and facilitate minimally invasive approaches. Although clinical trial data are available for SRDs in the United States, how their clinical outcomes compare with traditional stented bioprosthetic (SBP) valves is unknown in a post-approval, commercial setting. The Society of Thoracic Surgery Adult Cardiac Surgery Database was queried for patients who underwent an AVR. Transcatheter AVR cases were excluded. Thirty-day outcomes were compared between SRD valves (Perceval S [LivaNova, Houston, TX] and Intuity Elite [Edwards Lifesciences, Irvine CA]) and SBP valve patients. The SRD and SBP patients were propensity score-matched in a 1:(up to) 3 ratio. Primary outcome was 30-day mortality and secondary outcomes were major comorbidities, paravalvular regurgitation, and predischarge pacemaker implant. Propensity score matching resulted in 4486 SRD patients and 13,215 SBP patients. The SRD recipientshad more permanent pacemakers (11.4% vs 4.9%, P < .001) shorter cross-clamp times (median: 68vs 86 minutes, P < .001), and fewer full sternotomies (75% vs 77% , P < .024) than SBP but similar 30-daymortality (3.1% vs 3.1%, P= .98) and moderate or greater paravalvular regurgitation (0.2% vs 0.1%, P= .21). SRD implantation was associated with reduced operative times and smaller incisions. Rates of 30-day mortality, major comorbidities, and perivalvular regurgitation were similar between SRD and SBP patients. Longer follow-up is needed to determine the implications of increased permanent pacemaker implantation rates in SRD patients.

Transcatheter Tricuspid Valve-in-Valve Replacement by Transatrial Approach

Reoperation on the tricuspid valve after prior heart valve surgery is associated with an increased operative risk due to a poor clinical status with severe heart failure and late presentation. Transcatheter tricuspid valve-in-valve implantation emerged as an attractive alternative to a high-risk redo surgery. The authors report a case of successful treatment of a failed bioprosthetic tricuspid valve in a 58-year-old woman with severe heart failure, decompensated cardiac cirrhosis and atrial fibrillation using transcatheter tricuspid valve-in-valve implantation of a Sapien 3 valve (Edwards Lifesciences, Irvine, California) via a transatrial approach. This case demonstrates the efficiency of this novel approach for the treatment of dysfunctional surgical tricuspid bioprosthetic valves and the technical feasibility and safety of a rarely used route.