Risk Of Patient-prosthesis Mismatch Research Articles

First-in-human: Leaflet laceration with balloon mediated annihilation to prevent coronary obstruction with radiofrequency needle (LLAMACORN) for valve-in-valve transcatheter aortic valve replacement.

Coronary obstruction (CO) is a potential pitfall for transcatheter aortic valve replacement (TAVR), especially in valve in valve procedures into degenerated surgical or transcatheter prostheses. Bioprosthetic leaflet modification techniques that incorporate electrosurgery are evolving as the preferred strategy to mitigate the risk of CO in high CO risk settings. The UNICORN method is proposed as a more predictable leaflet modification strategy than the earlier described BASILICA approach, but its proponents have hitherto mandated the use of a balloon-expandable valve (BEV) prosthesis. Many patients have small prostheses and therein face a significant risk of patient prosthesis mismatch with BEV in this setting. This risk may be curtailed if a self-expanding valve (SEV) prosthesis could be used. Herein described is a modified approach to allow for the utilization of SEV systems in this setting.

In Vivo Computed Tomography Sizing for Redo-Transcatheter Aortic Valve Replacement in Evolut Valves: Impact on Sizing, Feasibility, and Prosthesis-Patient Mismatch.

SAPIEN3 (S3) is a ubiquitous redo-transcatheter aortic valve (TAV) replacement alternative for degenerated Evolut valves, but S3 sizing for S3-in-Evolut remains unclear. We sought to compare the impact of in vivo computed tomography (CT)-sizing on redo-TAV feasibility for S3-in-Evolut with traditional bench-sizing. CT scans of 290 patients treated using Evolut R/PRO/PRO+ between July 2015 and December 2021 were analyzed. S3-in-Evolut was simulated using S3 outflow/neoskirt plane (NSP) at node-6, -5, and -4. CT-sizing for S3 was determined by averaging 4 areas of the Evolut stent frame at NSP level and 3 nodes below. Redo-TAV was deemed feasible if the NSP was below the coronaries, or the narrowest valve (virtual S3)-to-aorta distance was >4 mm. Risk of prosthesis-patient mismatch was estimated using predicted indexed-effective orifice area. Compared with bench-sizing, CT-sizing yielded smaller S3 size in 82% at node-6, 81% at node-5, and 84% at node-4. Factors associated with CT-sizing less than bench-sizing were larger index Evolut size, underexpansion of index Evolut, and shallower implant depth (all P<0.05). CT-sizing increased redo-TAV feasibility by +8% at node-6, +10% at node-5, and +4% at node-4. Redo-TAV feasibility increased with annulus size, sinotubular junction dimensions, coronary heights, index Evolut size, deeper Evolut implant depth, and lower NSP levels (all P<0.05). CT-sizing had a slightly higher estimated risk of severe prosthesis-patient mismatch (9% at node-6, 7% at node-5, and 6% at node-4), which could be mitigated by changing the NSP. CT-sizing for S3-in-Evolut is associated with higher feasibility of redo-TAV compared with bench-sizing, potentially reducing the risk of excessive oversizing and S3 underexpansion. Further validation using real-world clinical data is necessary.

Aortic root enlargement and replacement of the ascending aorta in type 0 aortic valve stenosis.

This case report aims to describe an aortic root enlargement in combination with the replacement of the ascending aorta in a patient presenting with severe aortic valve stenosis. A 68-year-old woman with severe aortic stenosis due to a type 0 bicuspid aortic valve and an aortic aneurysm underwent surgery for treatment. The annulus was preoperatively measured with 19mm. Enlargement was performed by using a tissue patch to create a neo-noncoronary sinus and enlarge the root. Patients with a small aortic root face an increased risk of patient prosthesis mismatch. Enlarging the aortic root can mitigate this, but it extends cross-clamp and overall operative times. This case shows the need for carefully planned surgical interventions to optimize outcomes in complex anatomies. Each step of the performed surgery is well-established, however the combination and the creation of a neo-noncoronary sinus is not described so far.

Clinical Impact of Patient-Prosthesis Mismatch After Aortic Valve Replacement With a Mechanical or Biological Prosthesis.

Patient-prosthesis mismatch (PPM) may impair functional capacity and survival after aortic valve replacement. This study aimed to investigate the impact of PPM on long-term survival and quality of life after mechanical and biological aortic valve replacement. This study included 595 consecutive patients who had undergone isolated aortic valve replacement. Patients were divided into 2 groups according to prosthesis type. The baseline and operative characteristics, survival rates, complications, and quality of life of the groups with and without PPM were compared for up to 6 years. The PPM calculation was performed using the effective orifice area value provided by the manufacturer divided by the patient's body surface area. The moderate to severe PPM rates were 69.8% and 3.7% after biological and mechanical prosthesis implantation, respectively. Mean survival for patients in the biological group who had PPM was statistically significantly shorter (50.2 months [95% CI, 45.2-55.3]) than for patients in the biological group without PPM (60.1 months [95% CI, 55.7-64.4]; P = .04). In the mechanical prosthesis group, there was no difference in mean survival between the subgroup with PPM (66.6 months [95% CI, 58.3-74.9]) and the subgroup without PPM (64.9 months [95% CI, 62.6-67.2]; P = .50). A quality-of-life questionnaire's scores did not differ between the groups. Mismatch is common after biological valve implantation and statistically significantly affects long-term survival and quality of life. If the risk of PPM after implantation of a biological prosthesis is suspected, adopting strategies to avoid PPM at the time of surgery is warranted.

All surgical supra-annular aortic valvar tissue prostheses are labelled too large.

Surgical supra-annular aortic valvar tissue prostheses are labelled in an inconsistent and confusing manner. This increases the risk for patient prosthesis mismatch (PPM), when the replaced valve is too small for a given patient, which is associated with the risk of morbidity and mortality. Labelled diameter (LD) of these valves should coincide with inflow orifice diameter (IOD). Therefore, we set out to measure all relevant IOD's. Valvar design was assessed as to their intended position in relation to the patient's annulus. IOD's of all available supra-annular aortic valvar prostheses were measured using a conical gauge. IOD's were compared to LD's. We searched for instructions for use, websites, packing boxes and regulatory institutions involved in the process. Eight valve models of four manufacturers were included. None of these valves were clearly labelled as supra-annular on the packing box, although in three this could be found in the specifications. All valves had an IOD smaller than their LD, with a median difference of 15%, range: 4% - 25%. The departure from LD differed per valve model and valve size. Valve packages should be labelled accurately and clearly for surgeons to make a well-informed choice. Currently essential information is missing, since intended position in relation to the annulus is not consistently marked on the packing boxes, and valve sizes are labelled incorrectly. We propose a change for the better, and relabelling of all valves according to their true IOD in a structured manner.

Management of Failed Bioprosthetic Aortic Valves: Mitigating Complications and Optimizing Outcomes.

The use of bioprosthetic prostheses during surgical aortic valve replacements has increased dramatically over the last two decades, accounting for over 85% of surgical implantations. Given limited long-term durability, there has been an increase in aortic valve reoperations and reinterventions. With the advent of new technologies, multiple treatment strategies are available to treat bioprosthetic valve failure, including valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR). However, ViV TAVR has an increased risk of higher gradients and patient prosthesis mismatch (PPM) secondary to placing the new valve within the rigid frame of the prior valve, especially in patients with a small surgical bioprosthesis in situ. Bioprosthetic valve fracture allows for placement of a larger transcatheter valve, as well as a fully expanded transcatheter valve, decreasing postoperative gradients and the risk of PPM.

Aortic valve replacement using On-X valve in a child postorthotopic heart transplantation.

A 20-month-old girl presented with severe dilated cardiomyopathy and decompensated congestive cardiac failure. Despite escalating inotropic and mechanical ventilation support, she required placement on extracorporeal membrane oxygenation and transfer to the transplant centre in Newcastle, England. She was placed on biventricular assist device and then Berlin Heart but failed to show any recovery of ventricular function. She underwent orthotopic heart transplantation at 2 years of age. She developed bacterial endocarditis with Enterococcus faecalis resulting in severe aortic valve regurgitation requiring aortic valve replacement with a 19 mm On-X valve (Airtivion) 11 days after her transplant. Given the size of the donor heart, it was possible to implant a 19-mm valve in this 12 kg child with minimal risk of patient prosthesis mismatch. She was anticoagulated with warfarin (On-X valve INR 2-3 for first 3 months; INR 1.5-2.0 thereafter). Although she suffered several other post-operative complications, including malabsorption, nasojejunal feeding, liver dysfunction, vertebral fractures, renal impairment and renal calcification, and need for repeat opening of her tracheostomy site following her initial decannulation, her aortic valve function has remained stable.

Outcomes of aortic root enlargement during isolated aortic valve replacement.

Aortic root enlargement (ARE) lowers the risk of patient prosthesis mismatch after surgical aortic valve replacement (SAVR) in patients with small annular size. Whether AREis associated with increased operative mortality is controversial. This study compares the early and intermediate outcomes in patients undergoing SAVR with and without ARE. All patients undergoing isolated SAVR with and without ARE from 2015 to 2020 were analyzed. Propensity-matching was used to adjust for possible confounding variables. Kaplan-Meier analysis and log-rank test were used to estimate and compare overall outcomes and survival in the study cohorts. Among 868 isolated SAVRs, ARE was performed in 54 (6.2%) patients. Before matching, mean age was similar but female sex (67.4% vs. 29.6%; SD: -0.82) and previous AVR (18.9% vs. 3.9%; SD: -0.48) were more common in patients undergoing SAVR + ARE versus SAVR alone. A bovine pericardial patch was used for 81.5%(44 of 54) of ARE, with a Dacron patch in the rest. After propensity matching, the average cardiopulmonary bypass (138.2 ± 34.9 vs. 102.9 ± 33.0 min; p < 0.01) and cross-clamp times (113.8 ± 26.7 vs. 83.0 ± 28.4 min; p < 0.01) were longer in the SAVR + ARE group. There were no significant differences in postoperative stroke, new-onset dialysis, pacemaker placement, reoperation for bleeding, length of hospital stay, or 30-day readmission. Thirty-day mortality (0% vs. 0.6%, p = 1.0) and 5-year survival (96.3% vs. 95.7%, p = 0.86) were also similar. ARE during surgical AVR can be safely performed without an increase in complications with excellent early and intermediate-term survival.

TAVI - New Frontiers

TAVI - New Frontiers Abstract. In this overview, the current major challenges in the field of TAVI are discussed with available supporting data. Valve-in-valve procedures have become routine with reliable evidence to optimise outcomes and minimise the risk of patient prosthesis mismatch. Treating bicuspid aortic valve anatomy remains a challenge with no imminent sign of randomised data to assist treatment decisions; however, it seems clear that improving transcatheter technology and operator experience can lead to excellent results in selected patients. Despite the lingering risk of valve leaflet thrombosis, dual-antiplatelet therapy after TAVI appears to do more harm than good in comparison to single antiplatelet therapy. Whether oral anticoagulation may yet tip the scales toward net clinical benefit remains to be determined. Finally, with TAVI firmly established as the preferred treatment for patients with high and intermediate surgical risk, and as a suitable alternative to surgery in some low risk patients, increasing attention is being turned to the timing of valve intervention. In particular, there is a clear trend away from the traditional symptomatology and strict haemodynamic parameter-driven strategies that have dictated treatment algorithms until now, toward investigating and treating aortic stenosis before the occurrence of deleterious extra-valvular effects.

Aortic Annular Enlargement in the Elderly: Short and Long-Term Outcomes in the United States

BackgroundPatient prosthesis mismatch is associated with significant long-term morbidity and mortality after aortic valve replacement, but the role and outcomes of annular enlargement (AE) remain poorly defined. We hypothesized that increasing rates of AE may lead to improved outcomes for patients at risk for severe patient prosthesis mismatch. MethodsPatients over age 65 years undergoing surgical aortic valve replacement with or without coronary artery bypass grafting from 2008-2016 in The Society of Thoracic Surgeons Adult Cardiac Surgery Database with matching Centers for Medicare & Medicaid Services data were included (n=189,268). Univariate, multivariate, and time-to-event analysis was used to evaluate the association between AE and early and late outcomes. Patients were stratified by projected degree of patient prosthesis mismatch based on calculated effective orifice area index. ResultsA total of 5412 (2.9%) patients underwent AE. The Society of Thoracic Surgeons Adult Cardiac Surgery Database–predicted mortality was similar between AE and non-AE groups (2.97% vs 2.99%, P = .052). Patients undergoing AE had higher risk-adjusted rates of 30-day complications and death (5.4% vs 3.4%, P < .0001), but no differences in long-term rates of stroke, heart failure re-hospitalization,s or aortic valve reoperation. Survival analysis demonstrated a higher risk of mortality with AE during the first 3 years, after which the survival curves cross, favoring AE. ConclusionsThese data suggest that annular enlargement during surgical aortic valve replacement is associated with increased short-term risk in a Medicare population. Survival curves crossed after 3 years, which may portend a benefit in select patients. However, annular enlargement is still only performed in the minority of patients who are at risk for patient prosthesis mismatch.

Preoperative multidetector computed tomography for isolated surgical aortic valve replacement: Planning for future transcatheter options.

Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) has become a valuable option in patients with bioprosthetic failure. However, potential issues with ViV TAVR may occur in patients with high-risk anatomy for coronary obstruction and patients with baseline smaller bioprosthetic valves at risk for patient prosthesis mismatch. The purpose of this study was, therefore, to use preoperative electrocardiography-gated, multidetector computed tomography (MDCT) in patients undergoing isolated surgical aortic valve replacement (SAVR) to (1) identify which would be high risk for coronary occlusion with ViV TAVR, and (2) predict intraoperative SAVR sizing. Among 223 patients from our institutions' database that underwent SAVR for aortic insufficiency (AI) or aortic stenosis (AS) between January 2012 and January 2020, 48 patients had MDCT imaging before surgery (AI; n = 31, AS; n = 17). Of all patients, 67% (n = 32) were bicuspid morphology. With the use of virtual valve implantation, all patients with AI and bicuspid AS had feasible anatomy for ViV TAVR, while 38% of patients with tricuspid AS were high risk for coronary obstruction. There was a strong correlation between actual valve size implanted and preoperative MDCT measurements using annulus average diameter, area, and/or perimeter. Preoperative MDCT in patients undergoing SAVR is a useful tool for lifetime management, particularly in patients with tricuspid AS. Decisions for surgical management may change based on MDCT's ability to predict intraoperative SAVR size and determine which patients may be high-risk candidates for future ViV TAVR due to coronary artery obstruction.

Prosthesis-patient mismatch after transcatheter aortic valve implantation: prevalence and prognostic impact with respect to baseline left ventricular function

We aimed to assess the prevalence and features of prosthesis-patient mismatch (PPM) following transcatheter aortic valve implantation (TAVI) and its prognostic impact considering baseline left ventricular ejection fraction (LVEF). Data from 1,309 patients undergoing TAVI for severe aortic stenosis were derived from a single-centre dedicated TAVI registry. PPM was assessed according to echocardiography at discharge and was defined in accordance with VARC-2. Median follow-up time was 2.03 years. Moderate and severe PPM was detected in 22.9% and 12.9%, respectively. Patients with severe PPM had smaller annuli and more often received transcatheter heart valve (THV) sizes ≤23 mm. Supra-annular THV design showed the lowest rate of PPM. In patients with LVEF <40%, but not in those with LVEF ≥40%, severe PPM was associated with an increased three-year mortality rate (no vs. severe PPM for LVEF ≥40%: 34.6% vs. 29.5%, p=0.96; LVEF <40%: 45.1% vs. 68.0%, p=0.041) and was independently predictive of all-cause mortality according to multivariate analysis in these patients (HR 2.97; 95% CI: 1.58-5.59, p<0.001). The presence of severe PPM depends on annular dimensions and THV size and design and is an independent predictor of mortality in patients with reduced LVEF. Hence, the risk of PPM should be considered within the process of THV selection.

The Prognostic Significance of Patient-Prosthesis Mismatch after Aortic Valve Replacement.

Patient-prosthesis mismatch (PPM) is a controversial issue in current clinical practice. PPM has been reported to have a negative impact on patients’ prognosis after aortic valve replacement in several studies, showing increased all-cause and cardiac mortality. Moreover, a close relationship has recently been described between PPM and structural valve deterioration in biological prostheses. In patients at risk for PPM, several issues should be considered, and in the current era of cardiac surgery, preoperative planning should consider the different types of valves available and the various surgical techniques that can be used to prevent PPM. The present paper analyses the state of the art of the PPM issue.

Sutureless aortic valve replacement: a theoretical analysis of the effective orifice area in comparison with stented valves

Objective: Sutureless aortic valve replacement has recently been introduced as an alternative to conventional surgery to minimize the operative risk in elderly patients, shortening the cardiopulmonary bypass time and enhancing the minimally invasive approach. The aim of our study is to demonstrate that the sutureless bioprosthesis, compared to a conventional sutured prosthesis, has a corresponding larger effective orifice area, resulting in a better hemodynamic performance of the left ventricle. Materials and methods: In this prospective observational study, between January 2014 and September 2015, among our population of 37 sutureless aortic valve replacements, we examined 17 patients (sutureless, A group), in which a second measurement with a standard stented valve sizer has been performed during surgery. As a control group, we analyzed 10 additional aortic valve replacements who received conventional stented bioprosthesis (sutured, B group), in which an additional measurement with the sutureless sizer has been used to compare size and effective orifice areas differences between the sutureless and the sutured valves for any given annulus. Results: The size of the implanted bioprosthesis was 23,1 ± 1,9 mm and 23 ± 1,6 mm for the sutureless and sutured groups, respectively. In both groups, there were significative differences between the effective orifice areas of the implanted and the control sized prosthesis, always in favour of the sutureless valve (sutureless, A group: 2,6 ± 0,3 vs 1,4 ± 0,0 cm2, p < 0,001; sutured, B group: 1,5 ± 0,2 vs 2,9 ± 0,3 cm2, p < 0,001). Conclusions: Previous studies compared nominal sizes regardless of the effective orifice areas. For the first time, we analyzed the areas of the sutureless versus sutured bioprosthesis. For every single patient considered, the effective orifice area was significantly larger with the sutureless rather than with the sutured bioprosthesis that could fit. In sutureless aortic valve replacements, the benefits go far beyond the cardiopulmonary bypass and cross-clamp time reduction, providing larger areas and less risk of patient-prosthesis mismatch.

Stentless versus Stented Bioprosthetic Aortic Valves

: The purpose of this consensus conference was to determine whether stentless bioprosthetic valves improve clinical and resource outcomes compared with stented valves in patients undergoing aortic valve replacement, and to outline evidence-based recommendations for the use of stentless and stented bioprosthetic valves in adult aortic valve replacement. : Before the consensus conference, the best available evidence was reviewed in that systematic reviews, randomized trials, and nonrandomized trials were considered in descending order of validity and importance. At the consensus conference, evidence-based statements were created, and consensus processes were used to determine the ensuing recommendations. The American Heart Association/American College of Cardiology system was used to label the level of evidence and class of recommendation. : Seventeen randomized studies published in 23 articles involving 1317 patients, and 14 nonrandomized trial published in 18 articles involving 2485 patients were included in the meta-analysis and consensus conference. All randomized trials inserted the stentless bioprosthetic valves in the subcoronary configuration. The consensus panel agreed upon the following statements and recommendations in patients undergoing aortic valve replacement:Because there were no randomized control trial comparing subcoronary stentless prosthetic valve and root replacement, the following recommendations are derived from expert opinion:

Early and Midterm Results of Aortic Annular Enlargement

From November 1987 to May 1998, 16 patients with a small aortic annulus underwent patch enlargement of the aortic valve by Nicks' technique (in 9) or Manouguian's method (in 7). The mean age of the patients was 40 years (range, 22 to 58 years), mean body surface area was 1.54 m2 (range, 0.95 to 2.05 m2), and 11 were female. Concomitant procedures were mitral valve replacement in 4 cases, tricuspid commissurotomy and De Vega annuloplasty in 2, and one case each of patent ductus arteriosus ligation and coronary bypass. Aortic annular sizes were 15 to 19 mm (mean, 17.4 mm) preoperatively and 20 to 24 mm (mean, 22.1 mm) after the procedure. Two patients (12.5%) died in the early postoperative period. Peak pressure gradients across the prostheses were 15 to 22 mm Hg (mean, 19.4 mm Hg) on echocardiography. The mean duration of follow-up was 32.85 months (3 months to 8 years) and it was 92.8% complete. There were no late deaths. Mitral valve function was good except in one patient who had minimal mitral regurgitation after Manouguian's procedure. Both methods were found to be effective and reliable and should be performed when there is a risk of patient-prosthesis mismatch.