Leaflet Dimensions as a Guide to Remodeling Annuloplasty During Aortic Valve Repair.

OBJECTIVE: In chronic aortic insufficiency (AI), the method and degree of annular downsizing required to achieve durable coaptation in aortic valve repair (AVr) remains poorly defined. This study evaluated the relationship between leaflet size and annular diameter to predict adequate annular sizing in remodeling AVr. METHODS: Under regulatory supervision, 74 patients with chronic tri-leaflet AI underwent AVr using ring annuloplasty and leaflet reconstruction. Fifty-four (73%) had ascending aortic (n = 25) and/or root (n = 29) aneurysms, and aortic grafts were sized 5 to 7 mm larger than the rings. Intraoperatively, leaflet free-edge length (FEL) was measured with special ball sizers positioned in the coronary sinus, and "normal" annular diameter was predicted from the validated formula: Required "normal" diameter = FEL/1.5. "Normal" annular diameters predicted from FEL were compared with pathologic diameters measured intraoperatively with Hegar dilators, and both were correlated with gender, age, and BSA. RESULTS: Average age was 62.1 ± 13.3 years (mean ± SD), 73% (54/74) were male, and 96% (71/74) had moderate-to-severe AI. All patients had annular dilatation, with a pathologic diameter 26.6 ± 2.3 mm before repair, and a predicted "normal" diameter of 21.7 ± 1.7 mm (P < 0.001). Both predicted and pathologic annular diameters were larger in men (P < 0.001), but no relationship existed with age. BSA correlated with both predicted and pathologic diameters, although variability was large. CONCLUSIONS: Based on a simple validated method to predict "normal" annular diameter, all patients with chronic AI have some degree of annular dilatation. This finding implies that most AVr should include annuloplasty, with adequate and precise annular reduction based on leaflet size.

Bicuspid aortic valve repair using geometric ring annuloplasty: A first-in-humans pilot trial.

OBJECTIVE: As bicuspid aortic valve (BAV) repair evolves, more effective annular reduction and stabilization could be advantageous. A geometric annuloplasty ring has been developed, and 2-year regulatory outcomes of a first-in-humans pilot trial are reported. METHODS: A prospective first-in-humans trial of BAV ring annuloplasty was completed in 16 patients. Patient age was 44.4 ± 11.3 (mean ± standard deviation) years, preoperative aortic insufficiency grade was 2.5 ± 1.0, New York Heart Association class 1.8 ± 0.4, and mean systolic gradient 13.4 ± 12.9 mm Hg. Three patients had Sievers type 0 BAV, 11 had type 1, and 2 were type 2. The Dacron-covered titanium rings had circular base geometry with 180° subcommissural posts and were implanted subannularly. Leaflets were reconstructed using plication/cleft closure, creating an effective height of ≥8 mm, even if modest gradients were induced. RESULTS: Mean pre-repair annular diameter was 28.6 ± 3.3 mm, and the average ring diameter was 22.3 ± 1.6 mm. All valves required leaflet plication/reconstruction; pericardium was avoided; and 7 patients had aortic replacement for aneurysms. No early mortalities or major complications occurred. Two patients required early prosthetic valve replacement for technical errors, and all were between 24-38 months' postoperative at follow-up. No late mortalities or valve-related complications occurred, and all patients reverted to New York Heart Association class I. Aortic insufficiency reduction was significant to grade 0.9 ± 0.5 at 2-years (P < .0001). Mean valve gradients were acceptable (13.3 ± 5.0 mm Hg at 2 years; overall P = .11) and tended to fall over time (P < .0001). CONCLUSIONS: Geometric ring annuloplasty was safe and effective for BAV repair. AI reduction was significant, valve gradients were satisfactory, and clinical outcomes were excellent. Geometric ring annuloplasty could simplify and standardize BAV repair.

Geometric Ring Annuloplasty for Aortic Valve Repair During Aortic Aneurysm Surgery: Two-Year Clinical Trial Results.

OBJECTIVE: An aortic annuloplasty ring could be useful for aortic valve repair. This trial evaluated intermediate-term outcomes of internal geometric ring annuloplasty for repair of trileaflet and bicuspid aortic insufficiency associated with ascending aortic and/or aortic root aneurysms. METHODS: Under regulatory supervision, 47 patients with aortic insufficiency and ascending aortic (n = 22) and/or aortic root (n = 25) aneurysms were managed with aortic valve repair and aneurysm resection. Valve repair was performed using trileaflet (n = 40) or bicuspid (n = 7) internal geometric rings, together with leaflet reconstruction. Ascending aortic and/or remodeling root replacements were accomplished with Dacron grafts 5 to 7 mm larger than the rings. An Echo Core Lab provided independent echocardiographic assessments, and changes over time were evaluated by Friedman tests. RESULTS: Mean ± SD age was 60 ± 14 years, 57% (27/47) were male, 15% (7/47) had bicuspid valves, 87% (41/47) had moderate-to-severe aortic insufficiency, and 13% (6/47) had mild aortic insufficiency. All patients had annular dilatation, with a mean ± SD of 26.5 ± 2.6 mm before repair, and mean ± SD ring sizes were 21.7 ± 1.7 mm. Follow-up was 42 months (mean = 27 months). No operative mortality or valve-related complications occurred. Two patients died beyond 1 year from nonvalve-related causes. One patient required valve replacement for repair failure. Survival free of complications or valve replacement was 94% at 2 years. Significant reduction in aortic insufficiency and New York Heart Association class were observed (P < 0.0001), and valve gradients remained low. No heart block or direct ring complications occurred. CONCLUSIONS: In preliminary regulatory studies, aortic ring annuloplasty seemed safe and effective during aortic aneurysm surgery. This approach could help standardize aortic valve repair.

Right Minithoracotomy Versus Full Sternotomy for Mitral Valve Repair: A Propensity Matched Comparison.

BACKGROUND: Mitral valve (MV) repair through a right minithoracotomy (RT) is technically more demanding than through a median sternotomy (MS) and has been cited for a higher rate of reoperation, increased postoperative bleeding, thromboembolic events, poor visualization, and longer operative times. Randomized studies are not available, however, and specific characteristics of patients who undergo operation with either technique are usually highly different. Therefore, a propensity matching study was performed to reduce selection bias. METHODS: A retrospective analysis was made of 745 patients, 501 in group RT (67%) and 244 in group MS (33%), who underwent isolated MV repair between 2000 and 2010. Propensity matching identified 97 matched patient pairs for comparison of functional outcome, survival, incidence of reoperation, and quality of life after MV repair. RESULTS: Propensity matched patients in group RT had longer cardiopulmonary bypass time (120 ± 28 versus 99 ± 30 minutes, p < 0.001) and cross-clamp time (86 ± 23.5 versus 74 ± 25 minutes, p < 0.001). Thirty-day mortality was similar for both groups (RT, 0%; MS, 1%; p = 0.13). There were no significant differences in other outcomes such as amount of red blood cell transfusion, ventilation time, and hospital stay. Five-year survival in group RT (93.5% ± 3.7%) versus group MS (87.4% ± 3.6%, p = 0.556) and freedom from MV reoperation (93.3% ± 2.9% versus 97.9% ± 1.5%, respectively; p = 0.157) were not different. Functional outcome and quality of life variables were similar. CONCLUSIONS: Mitral valve surgery through a right minithoracotomy is a safe procedure associated with a very low operative mortality comparable to the standard sternotomy approach. In addition to improved cosmetics, minimally invasive MV surgery provides equally durable results as the standard sternotomy approach.

Placement of Neochords in Mitral Valve Repair: Enhanced Exposure of the Papillary Muscles Using a Standard Valve Sizer.

Minimally invasive mitral valve repair with placement of artificial chordae for mitral valve regurgitation has become the standard of care. In some cases, such as Barlow's disease or bileaflet prolapse, papillary muscle exposure may be difficult. By using a valve sizer to retract both leaflets, visualization can be optimized, thus simplifying suture placement and thereby minimizing cross-clamp and cardiopulmonary bypass times. This technique is simple, is cost effective, and can be applied quickly.

Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device.

OBJECTIVES: This study assessed the safety and efficacy of an internal geometric annuloplasty ring in a regulatory trial of aortic valve reconstruction (ClinicalTrials.gov Identifier: NCT01400841). METHODS: Sixty-five patients with predominant moderate-to-severe trileaflet aortic insufficiency (AI) underwent aortic valve repair with an average age of 63 ± 13 years (mean ± SD). All had initial implantation of an internal aortic annuloplasty ring to correct annular dilatation and facilitate leaflet reconstruction. Leaflet plication was performed for prolapse in 80% of patients, and more complex leaflet procedures, usually employing autologous pericardium, were required in 22%. Ascending aortic and/or root aneurysms were replaced in 62%. RESULTS: Follow-up was for a maximum of 3 years and a mean of 2 years. No in-hospital operative mortalities, major complications or early or late valve-related events occurred. The annular diameter before repair was 26.5 ± 2.3 mm, and the average ring diameter used was 21.5 ± 1.6 mm. The preoperative AI grade (0-4) was 2.9 ± 0.8 and improved after repair to 0.6 ± 0.7 (P < 0.0001), as did the NYHA class. The mean valve gradient was 8.6 ± 4.3 mmHg, and at 3 years, the Kaplan-Meier survival rate was 95%, with no valve-related mortality. Over the 3 years, aortic valve replacement was required in 7 patients (10.8%) for reasons usually related to surgical technique. Most repair failures occurred early, and results stabilized after 6 months. No structural complications of the rings were observed. CONCLUSIONS: Geometric ring annuloplasty was a safe and effective adjunct to aortic valve repair. Initial correction of annular dilatation seemed to facilitate overall reconstruction. Because most early repair failures were technical, increasing experience with geometric ring annuloplasty for aortic valve reconstruction has the potential to standardize and improve outcomes.

Complete Aortic Valve Cusp Replacement in the Pediatric Population Using Tissue-Engineered Bovine Pericardium.

Three clinical cases of severe pediatric aortic valve defects undergoing complete aortic valve cusp replacement using tissue-engineered bovine pericardium are reported. All patients achieved excellent early results, and are being followed without complications.

First-in-Man, Mitral Valve-in-Valve Transcatheter Implantation Through an Innovative Minimally Invasive Surgical Approach.

Degeneration of a surgically implanted valve bioprosthesis may occur in elderly, frail patients with an extremely high risk to undergo redo cardiac surgery. Transapical or fully percutaneous transseptal approaches have been described in order to treat degenerated aortic and mitral bioprosthesis. We performed the first-in-man successful mitral transcatheter valve delivery with a valve-in-valve technique through an innovative route; ie, a video-assisted endoscopic direct access to the left atrium, in an 82-year-old patient who previously underwent surgical replacement of the mitral valve and with a prohibitive surgical risk.

A Regulated Trial of Bicuspid Aortic Valve Repair Supported by Geometric Ring Annuloplasty.

BACKGROUND: Annular stabilization is important during bicuspid aortic valve (BAV) repair to obtain the best long-term results. This report describes the early outcomes of a novel bicuspid annuloplasty ring for this purpose. METHODS: Under regulatory supervision (NCT02071849), a geometric bicuspid annuloplasty ring was used during valve repair in 16 patients. Three patients had Sievers type 0 valves, 11 had Sievers type 1, and 2 had Sievers type 2. Thirteen patients had left-/right-coronary cusp fusion, 1 had right-/noncoronary cusp fusion, and 2 had both. Moderate to severe aortic insufficiency (AI) was present in 13 of 16 patients, and 3 had mild AI with aortic aneurysms. Ascending aortic aneurysms, root aneurysms, or both were replaced in 7 of 16 patients. The Dacron-covered titanium ring had circular base geometry and two outwardly flaring subcommissural posts positioned opposite on the circumference. The ring was implanted into the annulus beneath the valve, and then leaflet repair was performed. RESULTS: Immediate postrepair echocardiograms showed grade 0 residual AI in all patients, with good cusp mobility and effective height, and satisfactory gradients. There were no in-hospital or late mortalities. Two patients experienced leaflet tears from long annular suture tails, requiring late valve replacement. After implementation of a lateral suture fixation technique, no more failures occurred. At a mean follow-up time of 9 months, the remaining 14 patients were in New York Heart Association class I, with predominant grade 0 AI. CONCLUSIONS: As a technique for BAV repair, internal ring annuloplasty produces major annular remodeling and stabilization. Annular reduction and reshaping to a 50/50% symmetric circular geometry facilitates leaflet repair and enhances cusp coaptation. Geometric ring annuloplasty could have useful applications in BAV repair.

A geometric model of the normal human aortic root and design of a fully anatomic aortic root graft.

OBJECTIVE: Available aortic root grafts generally flare outward in the sinus region, and this feature improves procedural ease. However, no current device is based on normal aortic root geometry, and a fully anatomic aortic root graft could further facilitate valve-sparing root operations. METHODS: To develop a model of the normal human aortic root, high-resolution computed tomographic angiogram images from 11 normal human aortas generated high-density x, y, z coordinates of valve and root structures in Mathematica. Three-dimensional least-squares regression analyses assessed geometry of the aortic valve and root. Shapes and dimensions were quantified, and minor variations in geometry were simplified during graft design. RESULTS: Normal aortic valve and root geometry was represented as three leaflet-sinus general ellipsoids nested within a cylindrical aorta. Sinotubular junction diameter was 5 mm larger than the valve base-with a slight funnel-shaped outward commissural flare but cylindrical geometry above the midvalve. The valve base was elliptical, but the midvalve and the sinotubular junction were circular above the midvalve level. Commissural locations on the base circumference were equidistant. On the basis of average three-dimensional geometry, a root graft was designed for root remodeling procedures-to be used with an internal geometric annuloplasty ring of the same design. CONCLUSIONS: An aortic root graft was designed on the basis of mathematical analyses of computed tomographic angiogram images. The design incorporated three anatomic sinuses, commissural symmetry, and compatibility with geometric ring annuloplasty. The anatomic graft may prove useful for restoring aortic root geometry toward normal during aortic valve and root surgery.

Valve-sparing aortic root replacement in the presence of coronary anomalies.

Aortic root replacement in the presence of coronary anomalies can be challenging. Because the anomalous coronary often arises close to a commissure, reconstruction with traditional buttons can be technically difficult without compromising either the leaflets or the coronary artery. A method of valve sparing root surgery termed "aortic valve and root restoration," using aortic ring annuloplasty and formal valve repair, and then incorporating the anomalous coronary into the commissural suture line, may offer a simple solution to this problem.

Leaflet reconstructive techniques for aortic valve repair.

BACKGROUND: Refining leaflet reconstruction has become a primary issue in aortic valve repair. This descriptive analysis reviews leaflet pathology, repair techniques, and early results in a prospective regulatory trial of aortic valve repair. METHODS: Sixty-five patients underwent valve repair for predominant moderate to severe aortic insufficiency (AI). The mean age was 63 ± 13 years, and 69% of the patients were male. Ascending aortic/root replacement was required in 62%. As a first step, ring annuloplasty was performed, and then leaflet repair included leaflet plication for prolapse, nodular unfolding, double pericardial patching of commissural defects or holes, complete pericardial leaflet replacement, leaflet extension, and Gore-Tex reinforcement. Leaflet techniques and causes of adverse outcomes were evaluated. RESULTS: The follow-up time was 2-years maximal and 0.9 years mean, with a survival of 97%. Eighty percent of patients required repair of leaflet defects: leaflet prolapse (52/65-80%), ruptured commissures (6/65-9%), leaflet holes (4/65-6%), and nodular retraction (6/65-9%). The average preoperative AI grade of 2.9 ± 0.8 fell to 0.7 ± 0.7 (p < 0.0001). Three patients (4.6%) required interval valve replacement because of (1) suture untying, (2) iatrogenic leaflet tear, or (3) diphtheroid endocarditis. Five other patients experienced grade 2 or grade 3 AI: probable suture untying in 1 patient, ineffective leaflet extensions in 2 patients, and unsuccessful Gore-Tex reinforcements in 2 patients. Two patients with single pericardial leaflet replacements and all those with double pericardial reconstructions did well. CONCLUSIONS: Leaflet defects are common in patients with moderate to severe AI. Leaflet plication, nodular unfolding, and double pericardial patching performed well. Gore-Tex and leaflet extension seemed less satisfactory. Standardization and experience with leaflet reconstruction will be important for optimizing the outcomes of aortic valve repair.

Sex-related differences in 2197 patients undergoing isolated surgical aortic valve replacement.

OBJECTIVES: The aim of this study is to evaluate gender-related differences in clinical presentation and mortality in patients undergoing isolated surgical aortic valve replacement (SAVR). METHODS: We performed a retrospective analysis of all patients undergoing isolated SAVR from 2000 to 2011 in our center. Patient data were compared with regard to gender including baseline characteristics, 30-day, and late mortality. Kaplan-Meier survival curves were used to analyze long-term survival up to 10 years follow-up. Independent risk factors for 30-day and late mortality were identified using a Cox regression model. RESULTS: Two thousand one hundred ninety-seven patients were included, 1290 (58.7%) male patients and 907 (41.3%) female patients. Female patients were older (70 ± 11 vs. 64 ± 13 years, p < 0.001), presented with higher logistic EuroSCORE (7.5 ± 5.8 vs. 5.6 ± 6%, p = 0.006), and more common NYHA class III or IV (71 vs. 65%, p = 0.05). Male patients presented more often with LV dysfunction (7.5 vs. 2.8%, p < 0.001) and endocarditis (4.1 vs. 1.7%, p < 0.001) than female patients. Intraoperatively, female patients were more likely to have had a complete sternotomy (65 vs. 52%, p < 0.001) and SAVR with a bioprosthesis (87 vs. 78%, p < 0.001). Female patients exhibited a higher 30-day mortality (4.4 vs. 1.6%, p < 0.001) and late mortality (13 vs. 9.6%, p = 0.04) than male patients. After adjustment for baseline characteristics, only female gender was an independent predictor for 30-day mortality (HR 2.2, 95% CI 0.98 to 5.2, p = 0.05) and age as independent predictor for late mortality (HR 1.07, 95% CI 1.03 to 1.1, p < 0.001). CONCLUSION: Female patients were older and sicker and may therefore exhibit higher 30-day and late mortality than male patients. Female gender per se was a predictor for 30-day but not for late mortality.

Techniques of autologous pericardial leaflet replacement for aortic valve reconstruction.

Glutaraldehyde-fixed autologous pericardium rarely calcifies or retracts, and it is a useful substitute for cardiac valve leaflets. Current understanding of aortic valve geometry provides good models for aortic leaflet design, and pericardial leaflet construction is illustrated in this article for bicuspid and tri-leaflet valves. Outcomes have been characterized by low valve-related complication rates, and results of recent series are encouraging. Perhaps sufficient data are available to consider autologous pericardial leaflet replacement in highly selected younger patients with irreparable leaflets and contraindications to warfarin.

Erroneous measurement of the aortic annular diameter using 2-dimensional echocardiography resulting in inappropriate CoreValve size selection: a retrospective comparison with multislice computed tomography.

OBJECTIVES: This study sought to assess the differential adherence to transcatheter heart valve (THV)-oversizing principles between transesophageal echocardiography (TEE) and multislice computed tomography (CT) and its impact on the incidence of paravalvular leak (PVL). BACKGROUND: CT has emerged as an alternative to 2-dimensional TEE for THV sizing. METHODS: In our early experience, TEE-derived aortic annular diameters determined THV size selection. CT datasets originally obtained for vascular screening were retrospectively interrogated to determine CT-derived annular diameters. Annular dimensions and expected THV oversizing were compared between TEE and CT. The incidence of PVL was correlated to TEE- and CT-based oversizing calculations. RESULTS: Using TEE-derived annulus measurements, 157 patients underwent CoreValve implantation (23 mm: n = 66; 29 mm: n = 91). The estimated THV oversizing on the basis of TEE was 20.1 ± 8.2%. Retrospective CT analysis yielded larger annular diameters than TEE (p < 0.0001). When these CT diameters were used to recalculate the percentage of oversizing achieved with the TEE-selected CoreValve, the actual THV oversizing was only 10.4 ± 7.8%. Consequently, CT analysis suggested that up to 50% of patients received an inappropriate CoreValve size. When CT-based sizing criteria were satisfied, the incidence of PVL was 21% lower than that with echocardiography (14% vs. 35%; p = 0.003). Adherence to CT-based oversizing was independently associated with a reduced incidence of PVL (odds ratio 0.36; 95% confidence interval: 0.14 to 0.90; p = 0.029); adherence to TEE-based sizing was not. CONCLUSIONS: Retrospective CT-based annular analysis revealed that CoreValve size selection by TEE was incorrect in 50% of patients. The percentage of oversizing with CT was one-half of that calculated with TEE resulting in the majority of patients receiving a THV that was too small.

Early hemodynamic performance of the BioValsalva valved conduit after aortic root replacement.

BACKGROUND AND AIM OF THE STUDY: The study aim was to examine the hemodynamic performance of the BioValsalva porcine aortic valve conduit in the aortic root position. METHODS: Between February 2007 and April 2012, a total of 223 patients underwent aortic root replacement at the authors' institution. The BioValsalva valved conduit was implanted in 131 patients, and 86 of these patients (mean age 64.7 +/- 9.7 years) consented to participate in the present study. The parameters assessed to evaluate prosthetic valve function included mean pressure gradient (MPG) as measured by transthoracic Doppler echocardiography, and the effective orifice area (EOA) by means of the continuity equation. Hemodynamic data were obtained from all 86 patients within 10 days and six months postoperatively. RESULTS: The mean aortic cross-clamp time was 103 +/- 30 min. Concomitant procedures were performed in 50 patients (56.5%). Four patients developed valve dysfunction due to endocarditis, and underwent a reoperation without the need to perform a redo Bentall. The early MPG across the implanted valve was 12 +/- 4.6 mmHg (range: 4-24.8 mmHg), and the early mean EOA was 1.81 +/- 0.6 cm2 (range: 0.9-3.2 cm2). After six months the MPG was 11.6 +/- 4.6 mmHg (range: 2.2-25.5 mmHg) and the EOA was 1.69 +/- 0.43 cm2 (range: 0.8-2.6 cm2). CONCLUSION: Based on its special design with a stentless valve, which is not incorporated into the proximal suture line, the BioValsalva conduit has an advantage over intraoperatively prepared conduits in cases of reoperation. Besides simplified intraoperative handling, the BioValsalva conduit exhibits good systolic hemodynamic performance with large EOAs.

Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study.

AIM: Transcatheter aortic valve implantation has become an alternative to surgery in higher risk patients with symptomatic aortic stenosis. The aim of the ADVANCE study was to evaluate outcomes following implantation of a self-expanding transcatheter aortic valve system in a fully monitored, multi-centre 'real-world' patient population in highly experienced centres. METHODS AND RESULTS: Patients with severe aortic stenosis at a higher surgical risk in whom implantation of the CoreValve System was decided by the Heart Team were included. Endpoints were a composite of major adverse cardiovascular and cerebrovascular events (MACCE; all-cause mortality, myocardial infarction, stroke, or reintervention) and mortality at 30 days and 1 year. Endpoint-related events were independently adjudicated based on Valve Academic Research Consortium definitions. A total of 1015 patients [mean logistic EuroSCORE 19.4 ± 12.3% [median (Q1,Q3), 16.0% (10.3, 25.3%)], age 81 ± 6 years] were enrolled. Implantation of the CoreValve System led to a significant improvement in haemodynamics and an increase in the effective aortic valve orifice area. At 30 days, the MACCE rate was 8.0% (95% CI: 6.3-9.7%), all-cause mortality was 4.5% (3.2-5.8%), cardiovascular mortality was 3.4% (2.3-4.6%), and the rate of stroke was 3.0% (2.0-4.1%). The life-threatening or disabling bleeding rate was 4.0% (2.8-6.3%). The 12-month rates of MACCE, all-cause mortality, cardiovascular mortality, and stroke were 21.2% (18.4-24.1%), 17.9% (15.2-20.5%), 11.7% (9.4-14.1%), and 4.5% (2.9-6.1%), respectively. The 12-month rates of all-cause mortality were 11.1, 16.5, and 23.6% among patients with a logistic EuroSCORE ≤10%, EuroSCORE 10-20%, and EuroSCORE >20% (P< 0.05), respectively. CONCLUSION: The ADVANCE study demonstrates the safety and effectiveness of the CoreValve System with low mortality and stroke rates in higher risk real-world patients with severe aortic stenosis.