Balloon-expandable transcatheter heart valves for treatment of aortic valve stenosis in patients with large aortic annuli: Evaluation of deployment balloon overfilling strategies.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) using balloon-expandable (BE) transcatheter heart valves (THV) in aortic annuli above 29 mm includes particular procedural steps, mainly involving overfilling of the deployment balloon. Data on overfilling strategies in clinical daily practice is scarce. We herein aimed for a retrospective description of utilized overfilling strategies in those patients. METHODS: Between January 2016 and December 2022, 45 patients (100% male, 76.9 ± 6.1 years) received TAVI in aortic annuli above 29 mm using a BE THV. Overfilling volumina of the deployment balloon were left to operators' discretion. Clinical and multislice computed tomography data were retrospectively collected. Clinical endpoints were adjudicated in accordance with the updated standardized VARC-3 definitions. RESULTS: Profound overfilling (+4/5 mL) was used in patients with a mild calcium burden (˂750 mm³) even in aortic annuli of 29.0-30.0 mm. Nominal/slight overfilling (+1 mL) was used in aortic annuli up to 32.5 mm but an intermediate to severe calcific burden (>750-3200 mm³). Accordingly, a low calcification group (˂750 mm³, n = 17) compared to a significant calcification group (≥750 mm³, n = 28), presented with higher overfilling volumina (2.1 ± 1.4 vs. 0.8 ± 1.0; p ˂ 0.001), although aortic annulus diameter was not different (29.8 ± 0.8 vs. 29.9 ± 0.9 mm; p = 0.7). All-cause 30-day mortality was 0%. Device success was 97.8%. Transvalvular mean pressure gradient at discharge was 9.5 ± 3.6 mmHg. No case of PVL >mild was documented. CONCLUSION: Extent of overfilling of the deployment balloon largely depends on calcification burden in addition to aortic annulus diameter with significant and profound overfilling particularly in patients with a calcification burden of the aortic valve complex ˂750 mm³.

Use of Sutureless Valve in Aortic Root Enlargement.

AIM: The small aortic annulus is a surgical challenge in patients undergoing aortic valve replacement which may lead to patient prosthesis mismatch. Management options include aortic root enlargement, aortic root replacement, and the use of sutureless valves. In this case series, we report our results with aortic root enlargement, sutureless valve implantation, and benchtop modelling of the radial forces exerted. METHODS: Five patients underwent aortic root enlargement and insertion of the Perceval valve as part of the management strategy to enlarge their effective orifice area. We further investigate this strategy with a benchtop model to quantify the radial forces exerted by the Perceval valve on the aortic annulus. Radial and hoop forces on the aortic annulus and inner ring of the Perceval valve were recorded using a Mylar force tester. RESULTS: Five female patients with native annulus between 18mm-20mm underwent root enlargement and insertion of a Perceval S valve. The postoperative course was uncomplicated for all patients except for one who required a permanent pacemaker insertion. Transvalvular pressure gradients remained low at up to 4 years of follow-up (12 mmHg-21 mmHg), with no evidence of paravalvular leak. Benchtop testing demonstrated radial forces exerted at the annulus in all-size Perceval S valves to be within physiological variables, whereas compressive forces required to deform the valves were supraphysiological. CONCLUSIONS: The deployment of a sutureless valve within a surgical enlarged aortic root is a feasible solution in patients with a small aortic root.

Flanged Bentall and Cabrol Procedures for Complex Aortic Root Diseases.

For complex aortic root lesions, the flanged Bentall procedure has more advantages than the traditional one. Here, we report two patients with complex root lesions treated with the flanged Bentall and Cabrol procedure: one was a 25-year-old male with interventricular septal dissection with Behçet's disease, and the other was a 4-year-old female with a very large ascending aortic aneurysm with a small annulus and Loeys-Dietz syndrome. Both patients recovered uneventfully and obtained good short-term results.

Dilated ascending aorta in the fetus.

INTRODUCTION: Prenatal recognition of dilated aortic root is extremely rare and there are significant challenges in counselling these patients. The primary aim of this case series is to describe the prevalence, associations and outcome of dilated ascending aorta diagnosed during fetal life. METHODS: This is a retrospective cohort study from two tertiary fetal cardiology centres. Dilated ascending aorta was defined as gestation-specific standard deviation > 1.96 at some point during gestation. RESULTS: Sixteen infants were live born and underwent postnatal echocardiography. Prenatally suspected bicuspid aortic valve (BAV) (n = 6) was confirmed in 5 cases (83%) postnatally. Thirteen children have been followed up for a period of minimum one year. No connective tissue disease was found. CONCLUSIONS: Prenatal dilated ascending aorta is a rare finding (0.06%). It is associated with BAV in 37% of cases and extracardiac abnormalities in 15.7%. Nuchal translucency measurement was >3.5 in 13% of cases. Connective tissue disease was not diagnosed postnatally. This is the largest prenatal cohort with dilated ascending aorta and postnatal outcomes to date. We showed a postnatal persistence of ascending aortic dilatation in 43% of babies. In the absence of extra-cardiac abnormalities, medium term outcome appears good but postnatal surveillance of aortic dilation is required.

A modern approach to aortic valve insufficiency: Aortic root restoration via HAART 300 internal annuloplasty ring.

BACKGROUND AND AIM OF THE STUDY: HAART 300 is an internal geometric annuloplasty ring. The safety and efficacy of this novel device in aortic valve (AV) repair in a single referral center are reported. METHODS: Twenty patients with trileaflet AV insufficiency with ascending aorta and/or aortic root enlargement were included. Subannular implantation was performed to correct annular dilatation, whereas concomitant leaflet repair was performed whenever required. All but two patients also received ascending aorta replacement, whereas selective sinus replacement was performed in all but five patients. RESULTS: Follow-up was for a maximum of 3.8 years and a mean of 2.2 years. Mean age was 54.2 years old. Moderate to severe preoperative AV insufficiency was noted in 75% of patients, whereas 70% of them had an ascending aorta over 45 mm. One patient was lost from follow-up. Overall mortality as well as major complication rates were zero. Early postoperatively, no more than mild AV regurgitation was detected, whereas only one patient appeared with moderate AV regurgitation during our 2.2-year follow-up. New York Heart Association class was also significantly lower compared to preoperative values and valve gradients remained low at last follow-up. CONCLUSIONS: Geometric ring annuloplasty is a safe and effective valve sparing approach to deal with AV insufficiency contributing to overall root reconstruction. Short-term results are excellent rendering this easily reproducible and versatile method very attractive.

New-Generation Transcatheter Aortic Valves in Patients With Small Aortic Annuli　- Comparison of Balloon- and Self-Expandable Valves in Asian Patients.

BACKGROUND: Asian patients have smaller aortic annuli. Although 20-mm balloon-expandable (BE) transcatheter heart valves (THV) are manufactured for transcatheter aortic valve implantation (TAVI) in these cases, the supra-annular design of self-expandable (SE) THV is considered more suitable; however, real-world comparative data are scarce.Methods and Results:Consecutive TAVI cases (n=330) in a single Japanese center were reviewed. Based on the cutoff for the new-generation 20-/23-mm BE-THV, a small aortic annulus was defined as <330 mm2. A considerable number of patients had small annuli: 49/302 (16%). Of these, 33 BE-THV and 13 SE-THV using new-generation valves were compared. Although the SE-THV group had smaller annulus area (median 297 (interquartile range, 280-313) vs. 309 (303-323) mm2(P=0.022)), it had more favorable post-procedural parameters; for SE-THV and BE-THV, respectively, effective orifice area (EOA), 1.5 (1.3-1.6) vs. 1.1 cm2(0.9-1.3) (P=0.002); mean pressure gradient, 7.6 (5.6-11.0) vs. 14.2 mmHg (11.2-18.8) (P=0.001); and peak velocity, 1.8 (1.6-2.4) vs. 2.7 m/s (2.3-3.1) (P=0.001). Although new left bundle branch block was higher with SE-THV (24% and 62%, P=0.02), patient-prosthesis mismatch (PPM) ≥ moderate (indexed EOA <0.85 cm2/m2) was significantly less with SE-THV than with BE-THV (8% vs. 55%; P=0.04). Hemodynamic findings were consistent up to 1 year. CONCLUSIONS: Small annuli are often seen in Asian patients, for whom SE-THV implantation results in favorable hemodynamics with less PPM.

Aortic Geometry in Patients with Duplication 7q11.23 Compared to Healthy Controls.

The aim of this study was to compare the size and geometry of the aorta in patients with 7q11.23 duplication (Dup7) to healthy controls. We retrospectively reviewed all echocardiograms in all patients with Dup7 evaluated at our institutions from June 2017 through September 2019. All standard aortic diameter measurements were made and recorded. Z-scores for the measurements were calculated. For comparison, a set of control echocardiograms was developed by randomly selecting 24 normal echocardiograms in age-matched patients who had undergone echocardiograms for an indication of either chest pain or syncope. In 58 echocardiograms from 21 Dup7 patients, all aortic measurements were increased compared to controls (p < 0.0001). Effacement of the sinotubular junction (STJ) of the aorta was present in all Dup7 patients. Our novel STJ-to-aortic annulus ratio of ≥ 1.15 had a 98.28% sensitivity (95% CI 90.76-99.96) and 100% specificity (95% CI 85.75-100) for distinguishing Dup7 from controls with a positive predictive value of 100% and a negative predictive value of 96.00% (95% CI 77.47-99.41). All patients in our study with Dup7 had echocardiographic evidence of aortopathy. Effacement of the STJ was present in all Dup7 patients. The STJ-to-annulus ratio is a better indicator of aortopathy in Dup7 than the aortic Z-score.

Tissue "valve-over-valve" implantation in previous mechanical Bentall.

Multiple studies have reported the adverse impact of audible clicks from mechanical heart valves on the quality of life. Sadly, this can become a lifelong liability in younger patients necessitating explantation. Bioprosthetic valve replacement is the treatment for this distressing condition associated with an isolated mechanical valve. However, patients who have undergone a mechanical Bentall's procedure represent a unique surgical challenge. In view of the significant complications associated with a redo aortic root operation, the alternative of a "valve-over-valve" implantation is an attractive option that might present reduced morbidity. We report a unique case of valve noise intolerance in a patient who underwent a bioprosthetic valve-over-valve replacement following previous Bentall's procedure with a mechanical valved conduit.

A New Surgical Approach for Aortic Root Aneurysm and Small Aortic Annulus.

Reconstruction of the aortic root in patients with aortic root aneurysm and small aortic annulus is an intricate surgical procedure. Here, we describe our technique performed in 2 patients, that involved aortic root enlargement with grafting in conjunction with annular implantation of the composite graft with a prosthetic mechanical valve, which allowed us to avoid incompatibility. This novel method offers an alternative combined surgical approach for patients with small aortic annulus and aortic root aneurysm that preserves the structure of the valved conduit at the level of the aortic annulus.

Clinical Outcomes of Transcatheter Aortic Valve Implantation in Patients With Extremely Large Annulus and SAPIEN 3 Dimensions Based on Post-Procedural Computed Tomography.

BACKGROUND: Patients with severe aortic stenosis (AS) and an extra-large annulus (ELA) area (>683 mm2) can rarely be treated by transcatheter aortic valve replacement (TAVR) because of the size limitation of the transcatheter heart valves. This study aimed to evaluate the feasibility of TAVR using a 29-mm SAPIEN3 (S3) valve in patients with ELA and S3-dimensions by post-procedural computed tomography (post-CT). Methods and Results: We included 261 patients undergoing TAVR using a 29-mm S3: 30 patients with ELA and 231 with non-ELA were identified. S3-dimensions were evaluated at the S3 inflow and annulus level by post-CT in 129 patients. The ELA group had a greater aortic annulus area measured by pre-procedural CT (737.3±54.7 vs. 578.4±41.9 mm2, P<0.0001), higher balloon inflation volume (36 vs. 33 mL, P<0.0001), a larger S3 area at inflow by post-CT (729.6±42.2 vs. 682.2±35.0 mm2, P<0.001), and a correlation between the inflation volume and S3 area (r=0.71, P=0.0005). No differences were observed between groups in paravalvular aortic regurgitation (PAR) ≥mild (43.3% vs. 27.6%, P=0.09), PAR ≥moderate (3.3% vs. 1.3%, P=0.39) or 1-year mortality (10.0% vs. 9.1%, P=0.87). CONCLUSIONS: TAVR using a 29-mm S3 with extra inflation of the delivery balloon can be considered as a treatment option for patients with severe AS and ELA.

Overexpansion of the 29 mm SAPIEN 3 transcatheter heart valve in patients with large aortic annuli (area > 683 mm2 ): A case series.

OBJECTIVES: To evaluate overexpanded 29 mm SAPIEN (S3) transcatheter heart valves in patients with aortic annuli area >683 mm2 . BACKGROUND: The largest valve area the 29 mm S3 is specified for is 683 mm2 . Valve overexpansion has been performed in patients with larger aortic annuli, but data are limited. Moreover, feasibility in areas >740 mm2 is unknown. METHODS: All 29 mm S3 transcatheter aortic valve replacements (TAVR) at a single center over 23-months were retrospectively reviewed. Patients with annulus areas >683 mm2 were included. Immediate post-TAVR hemodynamics and transthoracic echocardiography (TTE) findings on post-TAVR day-1 and day-30 were recorded. RESULTS: Of 81 29 mm S3 TAVR cases, 3 (3.7%) met inclusion criteria (patients 1, 2, and 3 had CT-scan derived areas of 748.1 mm2 , 793 mm2 , and 787 mm2 , respectively). Annular eccentricity index ranged from 0.12 to 0.25. All underwent transfemoral TAVR with 29 mm S3 valves overexpanded using +4 mL of contrast. Post-dilatation with +5 mL was performed in patient 2. The average valve shortening was 10.68 mm. On day 1, patients 1 and 2 had trace and mild paravalvular leak (PVL) (respectively), whereas, patient 3 had mild-moderate PVL. Patient 1 was also noted to have trace central AR on day 1. No other central AR was noted. Immediate post-procedure aortic regurgitation (AR) index in patients 1, 2, and 3 was 43, 34, and 33 respectively. At 30 days, AR was completely resolved in patient 1, whereas AR severity in patients 2 and 3 remained similar. No patients had > moderate AR at any point during follow-up. No valve migration or embolization occurred. Patient 1 required a permanent pacemaker. No other major complications were noted. All patients were clinically stable at 30 days. CONCLUSIONS: TAVR using overexpanded 29 mm S3 in valve areas >740 mm2 (up to 793 mm2 ) seemed to be safe and feasible in our small series. Further study in a larger series is needed to determine clinical outcomes in this patient population.

Aortic Regurgitation in Acute Type-A Aortic Dissection: A Clinical Classification for the Perioperative Echocardiographer in the Era of the Functional Aortic Annulus.

The functional aortic annulus offers a clinical approach for the perioperative echocardiographer to classify the mechanisms of aortic regurgitation in acute type-A dissection. Comprehensive examination of the functional aortic annulus in this setting using transesophageal echocardiography can guide surgical therapy for the aortic root by considering the following important aspects: severity and mechanism of aortic regurgitation, extent of root dissection, and the pattern of coronary artery involvement. The final choice of surgical therapy also should take into account factors, such as patient presentation and surgical experience, to limit mortality and morbidity from this challenging acute aortic syndrome. This review explores these concepts in detail within the framework of the functional aortic annulus, detailed anatomic considerations, and the latest literature.

Transcatheter Aortic Valve Implantation In Patients With a Large Aortic Annulus.

BACKGROUND: As the indications for transcatheter aortic valve implantation (TAVI) have expanded, so to have the demands on interventionists to allow as many patients to access this technology as possible. METHODS: We retrospectively reviewed our TAVI database for patients who had received a 29mm SAPIEN 3 valve despite having an annular area greater than the manufacturer-recommended upper limit of 683mm2, as determined by multi-detector computed tomography (MDCT). Procedural and inpatient outcome data were collected. RESULTS: The study population was 5 of 121 patients receiving a SAPIEN 3 valve since it became available in March 2015. Their annular area ranged from 691 to 800mm2. Valve deployment was successful in all patients. The deployment balloon volume was nominal, except for an additional 1ml in one patient. No patient had a new indication for permanent pacing, and no significant valvular or paravalvular regurgitation (PVR) was identified on post-procedure transthoracic echocardiography. All patients survived to hospital discharge. CONCLUSIONS: In this select group of patients we have demonstrated that it is safe and feasible to use the 29mm SAPIEN 3 in patients with annular dimensions greater than those recommended, with minimal balloon overfilling.

Abnormal distortion of aortic corevalve bioprosthesis with suicide left ventricle, aortic insufficiency, and severe mitral regurgitation during transcatheter aortic valve replacement.

We present a patient with critical degenerative aortic stenosis, mitral annular and aortomitral continuity calcification, and senile sigmoid septal hypertrophy who underwent transcatheter aortic valve replacement using the CoreValve bioprosthesis. Immediately after predilation of the aortic valve (18-mm balloon), the patient developed severe hypotension and dynamic left ventricular outflow tract (LVOT) obstruction with systolic anterior motion of the anterior mitral leaflet, causing severe mitral regurgitation. After deployment of a 26-mm bioprosthesis, a transesophageal echocardiogram and left ventriculogram showed that the frame of the bioprosthesis appeared distorted and underexpanded. On the mitral side of the aorta (side of the aortomitral curtain between 12:00 and 3:00, echo short axis view), we found moderate periprosthetic aortic insufficiency with worse mitral regurgitation. The left ventricle was small and hyperdynamic (ejection fraction >85%). The patient soon developed complete heart block, atrial fibrillation, and ventricular tachycardia. She was resuscitated with aggressive intravenous fluids, vasopressors, and an emergently placed atrioventricular sequential pacemaker. We postdilated the 26-mm bioprosthesis with a 22-mm Z-Med balloon and subsequently with a 25-mm balloon. Each balloon was inflated to its nominal volume and pressure and conformed the nitinol frame of the valve to the net circular shape and expected diameter. However, as soon as each balloon was deflated, the surrounding aortic root anatomy visibly recoiled and the frame returned to its smaller diameter with a distorted shape. A second 26-mm CoreValve bioprosthesis was then deployed in a "valve-in-valve" configuration. Soon after, the patient's hemodynamics improved, her clinical condition stabilized, and she completely recovered. © 2016 Wiley Periodicals, Inc.

Aortic root volume is associated with contained rupture of the aortic annulus in balloon-expandable transcatheter aortic valve replacement.

BACKGROUND: Aortic annulus rupture is a rare, but potentially fatal complication of transcatheter aortic valve replacement (TAVR), especially when it occurs by balloon-expandable devices. In order to improve the predictability of procedures and avoid ruptures we investigated whether or not the aortic root volume measures is a useful indicator of risk, and if it could be useful for the prosthesis size selection. METHODS AND RESULTS: From a retrospective series of 172 TAVR patients, seven experienced contained aortic annulus ruptures. The receiver operating curves were used to illustrate sensitivity and specificity of the different aortic annulus size and aortic root volume measures. The annulus area oversizing of ≥20% resulted in a sensitivity of 100%, specificity of 55.76%, and positive predictive value (PPV) of 8.75%. In patients receiving 26 mm prostheses, the aortic root volume (ARV <13600 mm(3)) provided a better specificity and PPV (79.63 and 18.52%, respectively). A two-step testing procedure considering the area derived average annulus diameter (Darea <23 mm) as a first separating parameter and then the ARV (<13,600 mm(3)) as a further indicator showed the most promising results with the PPV of 31.25%. Regardless of the procedure steps no false negative results were predicted. CONCLUSIONS: Our data show that the ARV provides a better predictive value for correct prosthesis sizing than established annulus measurements, especially in 'borderline' annuli. We suggest a two-step testing procedure for prostheses size selection, considering Darea and ARV to minimize the risk of annulus rupture. Prospective studies and examination of larger datasets are warranted to confirm these findings.

The functional aortic annulus in the 3D era: focus on transcatheter aortic valve replacement for the perioperative echocardiographer.

The functional aortic annulus represents a sound clinical framework for understanding the components of the aortic root complex. Recent three-dimensional imaging analysis has demonstrated that the aortic annulus frequently is elliptical rather than circular. Comprehensive three-dimensional quantification of this aortic annular geometry by transesophageal echocardiography and/or multidetector computed tomography is essential to guide precise prosthesis sizing in transcatheter aortic valve replacement to minimize paravalvular leak for optimal clinical outcome. Furthermore, three-dimensional transesophageal echocardiography accurately can quantify additional parameters of the functional aortic annulus such as coronary height for complete sizing profiles for all valve types in transcatheter aortic valve replacement. Although it is maturing rapidly as a clinical imaging modality, its role in transcatheter aortic valve replacement is seen best as complementary to multidetector computed tomography in a multidisciplinary heart team model.

Multidimensional MDCT angiography in the context of transcatheter aortic valve implantation.

OBJECTIVE: Transcatheter aortic valve implantation has emerged as a viable treatment alternative for patients with severe aortic stenosis who are not surgical candidates. Multidimensional (3D and 4D) MDCT angiography plays a critical role in the safety, success, and outcome of an institutional transcatheter aortic valve implantation program. CONCLUSION: Given the increasing therapeutic role of this innovative technique, an understanding of essential imaging concepts in its context is critical for appropriate image acquisition and interpretation.

Pattern of aortic dilatation in different bicuspid aortic valve phenotypes and its association with aortic valvular dysfunction and elasticity.

OBJECTIVES: We aim to study the pattern of aortic dilatation in different BAV phenotypes and to find any correlations between aortic dilatation, aortic elasticity and AS and/or AR in our local population. METHODS: All BAV patients and controls were retrospectively studied. Aortic distensibility and stiffness index of the ascending aorta were calculated. RESULTS: A total of 191 patients with BAV and 180 controls were enrolled. Aortic dilatation involving a single site was more common with dilatation involving only the ascending aorta (R-N phenotype) and aortic root (N-L phenotype). AR was most common in patients with N-L and R-L phenotypes and AS in R-N phenotype. Aortic elasticity had no correlation with the different BAV phenotypes. CONCLUSIONS: There are different patterns of aortic dilatation in different BAV phenotypes, which may further contribute to the development of aortic stenosis or regurgitation. Aortic elasticity is independent of the BAV phenotypes and is impaired in BAV patients regardless of AS or AR severity.

Influence of preoperative aortic regurgitation on long-term autograft durability and dilatation in children and adolescents undergoing the Ross procedure.

OBJECTIVE: Primary aortic insufficiency (AI) is a risk factor for autograft reintervention in adults undergoing the Ross procedure. We sought to examine the influence of preoperative AI on autograft durability in children and adolescents. METHODS: From 1993 to 2020, 125 consecutive patients between ages 1 and 18 underwent a Ross procedure. The autograft was implanted using a full-root technique in 123 (98.4%) and included in a polyethelene terephthalate graft in 2 (1.6%). Patients with aortic stenosis (aortic stenosis group) (n = 85) were retrospectively compared with those with AI or mixed disease (AI group) (n = 40). Median length of follow-up was 8.2 years (interquartile range, 3.3-15.4 years). The primary end point was the incidence of severe AI or autograft reintervention. Secondary end points included changes in autograft dimensions analyzed using mixed-effect models. RESULTS: The incidence of severe AI or autograft reintervention was 39.0% ± 13.0% in the AI group and 8.8% ± 4.4% in the aortic stenosis group at 15 years (P = .02). Annulus z scores increased in both aortic stenosis and AI groups over time (P < .001). However, the annulus dilated at a faster rate in the AI group (absolute difference, 3.8 ± 2.0 vs 2.5 ± 1.7; P = .03). Sinus of Valsalva z scores increased in both groups as well (P < .001), but at similar rates over time (P = .11). CONCLUSIONS: Children and adolescents with AI undergoing the Ross procedure have higher rates of autograft failure. Patients with preoperative AI have more pronounced dilatation at the annulus. Akin to adults, a surgical aortic annulus stabilization technique that modulates growth is needed in children.