Stented Valve Research Articles

Perioperative platelet reduction after sutureless or stented valve implantation: results from the PERSIST-AVR controlled randomized trial.

Platelet count reduction is a common but not fully understood phenomenon after aortic valve replacement (AVR) with bioprosthesis implantation. The aim of the present study was to investigate the occurrence and the clinical impact of platelet count reduction in patients receiving the Perceval bioprosthesis compared to those receiving standard sutured stented bioprosthetic aortic valve in a randomized, controlled AVR study. PERceval Sutureless Implant versus STandard Aortic Valve Replacement is a prospective, randomized, adaptive, open-label trial. Patients were randomized (March 2016-September 2018) to AVR with a sutureless or stented valve. Ad hoc analyses have been performed to evaluate the occurrence of platelet count reduction and the clinical impact of the platelet variations in the 2 groups. The Perceval group showed a higher platelet reduction than the control group (46% vs 32%). The phenomenon was transient in both groups, with a slow recovery of the platelet count by hospital discharge. No differences were observed between groups regarding need of transfusions, blood loss, major bleeding and stroke events. The Perceval sutureless aortic bioprosthesis implantation is associated with higher rate of transient platelet reduction as compared to stented bioprostheses for AVR. However, the platelet count reduction is transient and the decline does not affect the patient's clinical outcomes. Current explanations for this phenomenon are speculative, and further investigations are required to elucidate it. NCT02673697-ClinicalTrials.gov-4 February 2016.

Simultaneous transcatheter treatment of ascending aortic aneurysm with aortic and mitral regurgitation: an in vitro study.

We sought to explore the efficacy of the endovascular repair of an ascending aortic aneurysm with aortic and mitral regurgitation by 2 novel valved stents. We established models of ascending aortic aneurysms combined with aortic and mitral regurgitation in 10 pig hearts, then implanted self-expanding aortic fenestrated and mitral valved stents via the transapical approach. We applied a fluoroscopy-guided in vitro setting to test the approach, then analysed continuous circulating flushing at 37°C. Finally, we determined operating times, echocardiography and changes of coronary flow as well as fenestration alignment with the coronary ostia. This approach resulted in a 100% overall technical success rate, excellent handling properties and precise positioning. The time taken to implant the 2 valved stents was 59 ± 12 min. Flow of the left and right coronary arteries did not significantly decrease after the stents were implanted (330.4 ± 12.06 ml/min vs 289.4 ± 5.29 ml/min, P < 0.001; 376.8 ± 10.5 ml/min vs 350.0 ± 14.5 ml/min; P < 0.001). We found no obvious regurgitation and perivalvular leakage; nor did the gradients of the aortic and mitral valves as well as of the left ventricular outflow tract increase significantly. The final angiographic examination and profile of the coronary opening confirmed the good position of the valved stents, the exclusion of the aneurysm and the patency of both coronary arteries. These findings indicate the potential for combined transcatheter aortic root and mitral valve replacement in treating aortic root pathologies. In future, in vivo studies are expected to validate this approach and ascertain its durability.

Strategies to Improve Survival from Surgery for Heart Valve Implantation in Sheep.

Sheep are a commonly used and validated model for cardiovascular research and, more specifically, for heart valve research. Implanting a heart valve on the arrested heart in sheep is complex and is often complicated by difficulties in restarting the heart, causing significant on-table mortality. Therefore, optimal cardioprotective management during heart valve implantation in sheep is essential. However, little is known about successful cardioprotective management techniques in sheep. This article reports our experience in the cardioprotective management of 20 female sheep that underwent surgical aortic valve replacement with a stented tissue-engineered heart valve prosthesis. During this series of experiments, we modified our cardioprotection protocol to improve survival. We emphasize the importance of total body hypothermia and external cooling of the heart. Furthermore, we recommend repeated cardioplegia administration at 20 min intervals during surgery, with the final dosage of cardioplegia given immediately before the de-clamping of the aorta. To reduce the number of defibrillator shocks during a state of ventricular fibrillation (VF), we have learned to restart the heart by reclamping the aorta, administering cardioplegia until cardiac arrest, and de-clamping the aorta thereafter. Despite these encouraging results, more research is needed to finalize a protocol for this procedure.

Impact of Patient Prosthesis Mismatch on the Outcome of Transcatheter Pulmonic Valve Implantation

Patient prosthesis mismatch (PPM) is an important factor of the outcome in transcatheter aortic valve implantation. However, the impact of PPM in transcatheter pulmonic valve implantation (TPVI) has not been studied. Based on the narrowest valve stent diameters in two views of fluoroscopy, internal geometric orifice area (GOA) of the valve stent was calculated and indexed by body surface area (BSA), deriving iGOA. To define PPM in TPVI, receiver operating characteristics (ROC) curve analysis for iGOA for predicting significant residual right ventricular outflow tract (RVOT) gradient was used to derive the optimal cut-off value of iGOA. Our cohort were divided into 2 groups: PPM versus non-PPM. The clinical data were compared between 2 groups. TPVI was performed using Melody valve in 101 patients. Significant RVOT residual pressure gradient (≥ 15 mmHg) was observed in 31 patients (39.6%). Over a mean follow up periods of 6.9 ± 2.7 years, 22 patients (21.8%) required repeat interventions (16 transcatheter, 11 surgical, and both in 5 patients). Based on the ROC analysis, the best cut-off value of iGOA was 1.25 cm2/m2 (area under the curve 0.873, p < 0.001) to define PPM. PPM was present in 42 patients (42%). On the Kaplan-Meier survival analysis, PPM was associated with the need of repeat intervention (p = 0.02). In conclusion, in TPVI, PPM was a strong predictor for the need of re-intervention. Considering PPM, target diameter of valve stent would depend on the patient body size and should be taken into account for optimal outcome of TPVI.

Left ventricular outflow tract area after percutaneous transseptal transcatheter mitral valve implantation: A three‐dimensional transesophageal echocardiography study

Left ventricular (LV) outflow tract (LVOT) obstruction increases mortality in patients undergoing transcatheter mitral valve implantation (TMVI) in degenerated bioprostheses, annuloplasty rings, and native mitral valves. We aimed to evaluate the LVOT area after TMVI using 3-dimensional (3D) transesophageal echocardiography (TEE) and to investigate the preprocedural cardiac geometry that affects the LVOT area after TMVI. We retrospectively reviewed echocardiography data in 43 patients who had TMVI. A change in pressure gradient across LVOT from before to after TMVI (∆PG) and postprocedure 3D LVOT cross-sectional area at the level of the most distal portion of the mitral valve stent that was closest to the LV apex were assessed as evidence of LVOT narrowing. Transcatheter mitral valve implantation with the use of balloon-expandable valve system was performed for 24 bioprostheses, 7 annuloplasty rings, and 12 native valves. Compared to patients without increase in LVOT gradient (∆PG <10mm Hg; n=33), patients with increase in LVOT gradient (∆PG ≥10mm Hg; n=10) had smaller LV end-systolic volume (LVESV), greater LV ejection fraction (LVEF), and smaller aorto-mitral (AM) angle. The LVOT area at the valve stent distal edge showed strong association with ∆PG (r=-.68, P<.0001). Only a small AM angle was associated with a small LVOT area at the valve stent distal edge on multivariable analysis, independent of LVESV and LVEF. Small LV size, preserved LVEF, and small AM angle were associated with LVOT narrowing. 3D-derived AM angle might be independently associated with LVOT narrowing in patients undergoing transcatheter mitral valve-in-valve, valve-in-ring, and valve-in-native valve implantation, independent of LVESV and LVEF.

Fifty years of the pericardial valve: Long-term results in the aortic position.

It is now 50 years since the development of the first pericardial valve in 1971. In this time significant progress has been made in refining valve design aimed at improving the longevity of the prostheses. This article reviews the current literature regarding the longevity of pericardial heart valves in the aortic position. Side by side comparisons of freedom from structural valve degeneration are made for the valves most commonly used in clinical practice today, including stented, stentless, and sutureless valves. Strategies to reduce structural valve degeneration are also discussed including methods of tissue fixation and anti-calcification, ways to minimise mechanical stress on the valve, and the role of patient prosthesis mismatch.

Durability of Pulmonary Valve Replacement with Large Diameter Stented Porcine Bioprostheses

There is limited information about durability of large diameter porcine bioprostheses implanted for pulmonary valve replacement (PVR). We studied patients who underwent surgical PVR from 2002-2019 with a stented porcine bioprosthetic valve (BPV) with a labeled size ≥27 mm. The primary outcome was freedom from reintervention. During the study period, 203 patients underwent PVR using a porcine BPV ≥27 mm, 94% of whom received a Mosaic valve (Medtronic Inc., Minneapolis, MN). Twenty patients underwent reintervention from 3.4-12.0 years after PVR: 5 surgical and 15 transcatheter PVR procedures. The indication for reintervention was regurgitation in 13 patients, stenosis in 2, mixed disease in 4, and endocarditis in 1. Estimated freedom from reintervention was 97±1% at 5 years and 82±4% at 10 years, and freedom from prosthesis dysfunction (moderate or severe regurgitation and/or a maximum Doppler gradient ≥50 mm Hg) over time was 91±2% at 5 years and 74±4% at 10 years. Younger age and smaller true valve diameter were associated with shorter freedom from reintervention, but valve oversizing was not. The durability of large stented porcine bioprostheses in the pulmonary position is generally excellent, particularly in adolescents and adults, similar to various other types of BPV. In the current study, relative valve size was not associated with valve longevity, although the low event-rate in this population was a limiting factor.

Interposition Technique for Pulmonary Valve Replacement.

Stented bioprosthesis implant at surgical pulmonary valve replacement (PVR) ideally should be 25 to 27 mm to facilitate future percutaneous PVR. This often requires accommodating 35 to 37 mm diameter sewing ring in the pulmonary position and requires anterior patch augmentation of the right ventricular outflow tract (RVOT). We present a novel "interposition" technique of PVR that allows upsizing the valve without RVOT patch augmentation. Using standard cardiopulmonary bypass, the main pulmonary artery (MPA) is dissected and transected at an appropriate level. The remnants of pulmonary valve leaflets are excised. The valve stent posts are telescoped into distal MPA, the MPA continuity is restored by end-to-end anastomosis of the proximal and distal MPA, with the interposed prosthetic valve sewing ring in the suture line between the two edges of the MPA with the bulk of the sewing ring extravascular. A total of seven patients (tetralogy of Fallot, three; congenital pulmonary stenosis, four; age range: 15-33 years) underwent the procedure. No patient required RVOT patch augmentation, all patients were extubated in the operating room and were fast-tracked to recovery. Our proposed technique of PVR has the following advantages: accommodate larger size valve, eliminates risk of a paravalvar leak, coronary compression, and anterior tilting of the prosthesis. The valve interposition technique avoids the need for RVOT patch, allows implantation of an adequate sized prosthetic valve, maintains native geometry of the pulmonary artery without the risk of tilting of the prosthesis, and eliminates the risk of paravalvular regurgitation and left coronary compression.

Mid-term outcomes of modified valve-sparing aortic root replacement versus the Bentall procedure for middle-aged Chinese patients with acute DeBakey I aortic dissection: a single-center retrospective study

BackgroundThe mid-term and long-term efficacies of valve preservation in acute DeBakey I aortic dissection (AD) are controversial. Thus, it is unclear whether middle-aged patients with acute DeBakey I AD should undergo modified valve-sparing procedures or the Bentall procedure in an emergency setting.MethodsThis study included 213 middle-aged Chinese patients (under 60 years old) who were treated for acute DeBakey I AD between January 2009 and June 2015. The treatments involved modified valve-sparing aortic root replacement (VSARR) (117 patients) or the Bentall procedure (96 patients). Preoperative, intraoperative, postoperative, and follow-up data were analyzed. Echocardiography and thoracoabdominal computed tomography angiography (CTA) findings were reviewed at 3 months, 1 year, and then annually after surgery.ResultsNo significant differences were observed in terms of the preoperative, intraoperative, in-hospital mortality, and postoperative parameters. There were also no significant differences in aortic regurgitation (AR). However, follow-up examinations using CTA revealed that 6 patients had endoleakage at the distal end of the triple-branched stent (0/110 patients [0.0%] vs. 6/90 patients [6.7%], P = 0.022). The anticoagulation-related thromboembolism/bleeding events was significantly lower in group A than in group B (0/110 patients [0.0%] vs. 11/90 patients [11.1%], P = 0.001). And postoperative aortic valve re-operation rate was significantly lower in group A (1/110 patients [0.9%] vs. 8/90 patients [8.9%], P = 0.020). There was no significant difference in survival during the follow-up period (log-rank P > 0.05).ConclusionFor middle-aged patients with acute DeBakey I AD, VSARR were associated with a lower rate of endoleakage at the distal end of the triple-branched stent, thromboembolism/bleeding events and aortic valve re-operation (vs. the Bentall procedure).

Late follow-up of Persistent Truncus Arteriosus, after one-stage Repair, with Right Ventricular Remodeling.

We report long-term outcome after one-stage, surgical repair, in a two months-old girl with persistent truncus arteriosus type I, II. The operation was carried out with the remodeling of the right ventricle, using a swine bicuspid pulmonary prosthesis. Twenty-six years later, the patient is in excellent clinical condition, CF I (NYHA), with normal peripheral oxygen saturation. Recent invasive and not invasive imaging show: absence of intracardiac shunt and growing of the right ventricle outlet tract and discrete double lesion of the pulmonary valve. The pulmonary flow directed uniformly for both lungs. In selected cases, the long-term prognosis of patients with persistent truncus arteriosus, undergoing early surgical repair, avoiding the use of valved conduit, makes for an excellent evolution, without new interventions. Endovascular procedures, now well standardized, for the implantation of a pulmonary valve stent, through a catheter, will allow an effective approach, in the presence of late obstructions, in patients who have undergone right ventricular remodeling, without the use of valved conduits.

Prosthesis-patient mismatch after aortic valve in valve procedure: incidence, predictors and clinical outcomes

Abstract Funding Acknowledgements Type of funding sources: None. Background. Transcatheter aortic valve-in-valve (TAVI ViV) implantation is an appealing treatment option for patients with degenerated bioprostheses. However, elevated residual gradients after TAVI ViV procedure are very common. These are an unwanted effects of prosthesis-patient mismatch (PPM). Currently, the actual incidenceof PPM, its predictors and its clinical outcomes have not been completely investigated. Purpose. The aims of this study was to investigate the incidence, predictors and clinical outcome of PPM and therefore of elevated gradients after TAVI ViV. Methods. 75 patients (age 78 ± 9 years, 36 male), who underwent TAVI-ViV due to failed aortic biological valve (60 stented, 15 stentless), were enrolled. Mechanism of bioprosthetic valve failure was stenosis (34 cases, 45%), regurgitation (24 cases, 32%) or combination (17 cases, 23%). Elevated residual gradients were defined as a mean DP&amp;gt; 20 mmHg. PPM was identified by the indexed effective orifice area (EOAi) measured by echocardiography (moderate PPM if 0.65 &amp;lt; EOAi &amp;lt; 0.85 cm²/m²; severe PPM if EOAi &amp;lt; 0.6 cm²/m²). Results. ViV TAVI was feasible in all patients, 33 patients (44%) were implanted with a balloon-expandable valve and 42 (56%) with a self-expandable valve. Post-procedural post-ballooning was performed in 16 out of 42 patients (38%) receiving a self-expandable valve. Post-operative mean DP&amp;gt; 20 mmHg was found in 35 patients (48%). Moderate PPM was found in 24 cases (33%) and severe PPM in 15 (20%). A logistic regression analyses identified small size of surgical prosthesis (size &amp;lt; 23 mm) [OR: 6.061(2.127-17.267), p = 0.001] and failed stented valve [OR: 20.727(2.522-170.364), p = 0.005] as independent predictors for the occurrence PPM. Interestingly PPM did not affect early and 1 years mortality (1 years mortality 1.3 %), while mortality was higher in pts with stentless prostheses (9%) Conclusions. PPM is a frequent finding after ViV procedures. Despite elevated residual gradients, TAVI ViV resolved prosthetic dysfunction and PPM did not affect mortality. Therefore, this procedure represents a promising new option for patients with failed biological prosthetic valves.

Transcatheter pulmonary valve replacement: a new polycarbonate urethane valve.

Transcatheter pulmonary valve replacement has become a valid treatment option for right ventricular outflow tract diseases. However, some limitations occur in patients with wide, compliant right ventricular outflow tracts that might be amenable to treatment with self-expanding valved protheses. An experimental ovine study was designed to evaluate a novel dip-coated, low-profile trileaflet polycarbonate urethane (PCU) heart valve mounted into a self-expandable nitinol stent. The PCU valves were produced by a dip-coating technique, mounted in a conical-shaped nitinol stent and provided with a leaflet thickness of 100-150 µm. The valved stents were implanted percutaneously via transfemoral access in 6 consecutive sheep divided into 2 groups. Three animals were followed up for 1 month and the remainder, for 6 months. Angiographic measurements and transthoracic echocardiography were performed before and after implantation and at the end of the 1- or 6-month observation period, respectively. Orthotopic positioning of the valve was achieved in all animals. All except 1 had competent valves during the follow-up period. The peak-to-peak gradient across the PCU valved stents was 4.6 ± 1.0 mmHg after 1 month and 4.4 ± 2.3 mmHg after 6 months of follow-up. Macroscopic and microscopic post-mortem evaluation indicated good morphological and structural results. There were no stent fractures, leaflet calcification or thrombus formation. This study demonstrates successful transcatheter pulmonary valve replacement with a novel dip-coated valved nitinol stent. The trileaflet PCU prostheses indicated good functional and biocompatible properties after a 6-month observation period.

Transcatheter Mitral Valve Replacement: A Novel Anchor Technology.

Mitral valved stents tend to migrate or to develop paravalvular leakage due to high-left ventricular pressure in this cavity. Thus, this study describes a newly developed mitral valved stent anchoring technology. Based on an existing mitral valved stent, four anchoring units with curved surgical needles were designed and fabricated using three-dimensional (3D) software and print technology. Mitral nitinol stents assembled with four anchoring units were successively fixed on 10 porcine annuli. Mechanical tests were performed with a tensile force test system and recorded the tension forces of the 10 nitinol stents on the annulus. The average maximum force was 28.3 ± 5.21 N, the lowest was 21.7 N, and the highest was 38.6 N until the stent lost contact with the annulus; for the break force (zero movement of stent from annulus), the average value was 18.5 ± 6.7 N with a maximum value of 26.9 N and a minimum value of 6.07 N. It was additionally observed that the puncture needles of the anchoring units passed into the mitral annulus in all 10 hearts and further penetrated the myocardium in only one additional heart. The anchoring units enhanced the tightness of the mitral valved stent and did not destroy the circumflex coronary artery, coronary sinus, right atrium, aortic root, or the left ventricular outflow tract. The new anchoring units for mitral nitinol stents were produced with 3D software and printing technology; with this new type of anchoring technology, the mitral valved stent can be tightly fixed toward the mitral annulus.

Comparison of safety and haemodynamic performance between the Avalus\u2122 stented aortic valve bioprosthesis and Magna\u2122 valve in Japanese patients

ObjectivesA new stented bovine pericardial valve (Avalus™) has been proven safe and effective with good hemodynamic performance in Western populations. However, its use in Japanese patients is poorly understood. We retrospectively compared the feasibility, safety, and valve haemodynamics between the Avalus™ and Magna™ valves in patients who underwent surgical aortic valve replacement (SAVR).MethodsThis study included 87 patients receiving an Avalus™ valve and 387 receiving a Magna™ valve. We evaluated adverse events, outcomes, and valve haemodynamics within 1 year postoperatively. There were no significant differences in any surgical risk scores.ResultsNo in-hospital mortality occurred in the Avalus™ group, but two mortality events occurred in the Magna™ group. No pacemaker implantation for complete atrioventricular block was required in the Avalus™ group. There was no significant difference in in-hospital or clinical outcomes between the two groups until 1 year postoperatively. Left ventricular mass index reduction appeared to predominate in the Avalus™ over Magna™ group. There was no significant difference in the mean pressure gradient or effective orifice area of each valve size at 1 week or 1 year between the two groups, apart from the mean pressure gradient of the 23-mm valve at 1 week. Three patients (3.4%) in the Avalus™ group and 39 (10.8%) in the Magna™ group (p = 0.12) had severe patient–prosthesis mismatch at 1 week postoperatively.ConclusionsThe new Avalus™ stented aortic valve bioprosthesis was associated with good in-hospital outcomes and good valve functionality post-SAVR in Japanese patients.

Bovine pericardial versus porcine stented replacement mitral valves: early hemodynamic performance and clinical results of a randomized comparison of the Perimount and the Mosaic valves.

BackgroundTo compare the hemodynamic and clinical outcomes following mitral valve replacement with the Perimount valve with those of the Mosaic valve.MethodsA total of 145 consecutive patients with rheumatic heart valve disease who underwent single bioprosthetic mitral valve replacement were randomized to receive either the Perimount (n=72) valve or the Mosaic bioprosthesis (n=73). The mean age of patients was 72.1 years (range, 58–89 years) with a sex distribution of 55.2% female and 44.8% male. Patients underwent follow up transthoracic echocardiography at 3 months and 1 year postoperatively. We compared demographics, preoperative clinical data, operative data, hemodynamic profiles, and clinical outcomes.ResultsThe cross-clamp time was similar, with 50.7±15.3 minutes for the Perimount and 50.7±21.8 minutes for the Mosaic bioprosthesis. The total bypass time was also similar, with 91.3±25.7 minutes for the Perimount and 87.8±25.6 minutes for the Mosaic valve. The peak and mean pressure gradients were lower in the Perimount group for all valve sizes and the difference was statistically significant at 1 year. The effective orifice area (EOA) was slightly larger in the Perimount valve (1.98±0.21 vs. 1.89±0.71 cm2, P=0.538) postoperatively, but there was no significant difference at 1 year. There were no differences in preoperative or postoperative left atrium diameter (LAD), left ventricular diastolic diameter (LVDD), left ventricular systolic diameter (LVSD), left ventricular ejection fraction (LVEF), pulmonary artery pressure (PAP). The mortality and major complications rate were similar between the two groups.ConclusionsThe Perimount prostheses is superior to the Mosaic prostheses after mitral valve replacement, achieving statistically significant lower gradients and larger EOA when compared on the basis of manufacturer-labeled valve sizes. Both valves appear to provide satisfactory clinical results.

Intraoperative Nursing Care of Patients Undergoing Transcatheter Aortic Valve Replacement via Femoral Artery Approach

<i>Objective:</i> Intend to explore the main points of intraoperative nursing care of patients with aortic valve stenosis undergoing transcatheter aortic valve replacement through femoral artery approach, summarize the scientific and effective nursing methods in operation. <i>Methods:</i> The intraoperative nursing methods of 9 patients undergoing transcatheter aortic valve replacement through femoral artery approach in our hospital from November 2019 to January 2021 were analyzed retrospectively. These methods include preoperative preparation, transmission of operative consumables, invasive blood pressure monitoring, use of high pressure syringe and temporary pacemaker, nursing of balloon dilatation and valve release, observation and nursing of intraoperative complications, postoperative nursing and so on. <i>Results:</i> The success rate of transcatheter aortic valve replacement was 100% in 9 patients who underwent transcatheter aortic valve replacement through femoral artery approach. In addition, the average operation time was 194.1 minutes. Besides, 1 case was implanted with middle valve, 1 case was protected by coronary artery, and 1 case was rescued during postoperative transportation. Moreover, no serious operative complications such as valve stent shedding, perivalvular leakage, coronary artery occlusion, stroke and malignant arrhythmia occurred in 9 patients. <i>Conclusion:</i> Full preoperative preparation, familiarity with the whole operation process and key steps, proficiency in the use of high pressure syringe and temporary pacemaker and nursing cooperation during balloon dilatation and valve release are the key to the successful completion of the operation in transfemoral approach transcatheter aortic valve replacement. Through active and effective intraoperative nursing, the operative quality of transfemoral artery approach transcatheter aortic valve replacement can be improved effectively, the operative time can be shortened, and the occurrence of intraoperative complications can be reduced, and the life safety of patients can be guaranteed.

Late Follow-Up of Persistent Truncus Arteriosus, after one-Stage Repair, With Right Ventricular Remodeling

We report long-term outcome after one-stage, surgical repair, in a two months- old girl with Persistent Truncus Arteriosus type I, II. The operation was carried out with the remodeling of the right ventricle, using a swine bicuspid pulmonary prosthesis. Twenty-six years later, the patient is in excellent clinical condition, CF I (NYHA), with normal peripheral oxygen saturation. Recent invasive and not invasive imaging show: absence of intracardiac shunt and growing of the right ventricle outlet tract and discrete double lesion of the pulmonary valve. The pulmonary flow directed uniformly for both lungs. In selected cases, the long- term prognosis of patients with truncus arteriosus, undergoing early surgical repair, avoiding the use of valved conduit, makes for an excellent evolution, without new interventions. Endovascular procedures, now well standardized, for the implantation of a pulmonary valve stent, through a catheter, will allow an effective approach, in the presence of late obstructions, in patients who have undergone right ventricular remodeling, without the use of valved conduits.

Sutureless versus conventional bioprostheses for aortic valve replacement in severe symptomatic aortic valve stenosis

ObjectiveSutureless aortic valves are a novel option for aortic valve replacement. We sought to demonstrate noninferiority of sutureless versus standard bioprostheses in severe symptomatic aortic stenosis. MethodsThe Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement is a prospective, randomized, adaptive, open-label trial. Patients were randomized (March 2016 to September 2018) to aortic valve replacement with a sutureless or stented valve using conventional or minimally invasive approach. Primary outcome was freedom from major adverse cerebral and cardiovascular events (composite of all-cause death, myocardial infarction, stroke, or valve reintervention) at 1 year. ResultsAt 47 centers (12 countries), 910 patients were randomized to sutureless (n = 453) or conventional stented (n = 457) valves; mean ages were 75.4 ± 5.6 and 75.0 ± 6.1 years, and 50.1% and 44.9% were female, respectively. Mean ± standard deviation Society of Thoracic Surgeons scores were 2.4 ± 1.7 and 2.1 ± 1.3, and a ministernotomy approach was used in 50.4% and 47.3%, respectively. Concomitant procedures were performed with similar rates in both groups. Noninferiority was demonstrated for major adverse cerebral and cardiovascular events at 1 year, whereas aortic valve hemodynamics improved equally in both groups. Use of sutureless valves significantly reduced surgical times (mean extracorporeal circulation times: 71.0 ± 34.1 minutes vs 87.8 ± 33.9 minutes; mean crossclamp times: 48.5 ± 24.7 vs 65.2 ± 23.6; both P < .0001), but resulted in a higher rate of pacemaker implantation (11.1% vs 3.6% at 1 year). Incidences of perivalvular and central leak were similar. ConclusionsSutureless valves were noninferior to stented valves with respect to major adverse cerebral and cardiovascular events at 1 year in patients undergoing aortic valve replacement (alone or with coronary artery bypass grafting). This suggests that sutureless valves should be considered as part of a comprehensive valve program.

Early Hemodynamics after Aortic Valve Replacement.

Background and objectives: The aims of this study were to investigate changes in the hemodynamics associated with different types of aortic prostheses and to evaluate patient-prosthesis mismatch (PPM) at rest and after exercise. Materials and Methods: We retrospectively analyzed 150 patients who presented with indications for aortic valve replacement (AVR) with/without concomitant surgery from March 2019 to January 2020. The study population included 90 (60%) men and 60 (40%) women (mean age, 67.33 ± 10.22 years; range, 37–88 years). Echocardiography data such as peak and mean transprosthetic pressure gradients (Gmax, Gmean), velocity (V), effective orifice area (EOA), and indexed EOA (iEOA) were derived at rest and after exercise at baseline and before discharge. The study patients performed the six-minute walk test (6MWT) on the 5th–7th postoperative day. Results: Stented tissue valves showed excellent performance at rest and after exercise in comparison with mechanical valves, which showed favorable hemodynamics at rest only. At the time of discharge, moderate PPM was observed in 7/74 patients (9.5%) at rest and 5/98 (3.3%) patients after exercise. None of the patients showed severe PPM. EOA and iEOA were not significantly different between the groups. However, the stented group showed more pronounced changes in EOA and iEOA after exercise, whereas the changes in the mechanical valve group did not reach significance. Conclusions: In the early postoperative period, mechanical valves and stented valves showed favorable resting hemodynamics. The PPM rate measured after exercise was lower than that at rest.

A preclinical trial of perventricular pulmonary valve implantation: Pericardial versus aortic porcine valves mounted on self-expandable stent.

Perventricular pulmonary valve implantation (PPVI) of a xenograft valve can be a less invasive technique that avoids cardiopulmonary bypass in patients who require pulmonary valve replacement. We compared the hemodynamics, durability, and histologic changes between two different xenogenic valves (pericardial vs. aortic valve porcine xenografts) implanted into the pulmonary valve position using a PPVI technique and evaluated the safety and efficacy of PPVI as a preclinical study. In 18 sheep, pericardial (group porcine pericardial [PP], n=9) or aortic valve (group porcine aortic valve [PAV], n=9) xenogenic porcine valves manufactured as a stented valve were implanted using a PPVI technique. The porcine tissues were decellularized, alpha-galactosidase treated, fixed with glutaraldehyde after space-filler treatment, and detoxified to improve durability. Hemodynamic and immunohistochemical studies were performed after the implantation; radiologic and histologic studies were performed after a terminal procedure. All stented valves were positioned properly after the implantation, and echocardiography and cardiac catheterization demonstrated good hemodynamic state and function of the valves. All the anti-α-Gal IgM and IgG titers were below 0.3 optical density. Computed tomography of extracted valves demonstrated no significant differences in the degree of calcification between the two groups (P=.927). Microscopic findings revealed a minimal amount of calcification and no significant infiltration of macrophage or T-cell in both groups, regardless of the implantation duration. The PPVI is a feasible technique. Both stented valves made of PP and PAV showed no significant differences in hemodynamic profile, midterm durability, and degree of degenerative dystrophic calcification.