Perivalvular Regurgitation Research Articles

Effect of TAVR generation on conduction abnormalities – is newer always better?

Abstract Objective Transcatheter aortic valve replacement has become an established approach to treat severe symptomatic aortic stenosis in patients of all risk levels. Development of conduction abnormality and the need for a permanent pacemaker are known complications of TAVR. The introduction of third generation valves with cuffs has resulted in a significant decrease in post-deployment perivalvular regurgitation. However, there is concern for an increase in development of a new onset left bundle branch (LBBB) and the need for permanent pacemaker (PPM) implantation. This study aimed to identify whether newer valve generations along with the move away from transesophageal echocardiography (TEE) guidance for valve deployment is associated with changes in frequency of conduction block. Methods 601 consecutive patients who underwent transfemoral TAVR implantation with a balloon expandable valve in a native aortic valve at a single institution from July 2009 to March 2019 were included in the study. 40 patients with LBBB and 91 patients with pacemakers prior to TAVR were excluded from the LBBB analysis. Multivariate logistic regression was used to test for significance. Results New LBBB occurred significantly more frequently with the newer generation valves, 1st Gen 2/104 (1.9%), 2nd Gen 9/88 (10.2%), 3rd Gen 33/278 (11.9%) (p<0.01). There was no statistically significant increase in pacemakers across valve generations, 1st Gen 7/113 (6.2%), 2nd Gen 7/92 (7.6%), 3rd Gen 30/305 (9.8%). Use of TEE guidance had no effect on either LBBB or pacemaker. There was a strong trend (p=0.057) toward need for pacemaker as larger valves where used, with OR of pacemaker relative to 29 mm valve for 23 mm valve of 0.26 and for 26 mm valve of 0.63. Conclusion Newer TAVR valves, although beneficial in reducing perivalvular regurgitation, increases the risk of LBBB, without increasing risk need for pacemaker, suggesting possibly different mechanisms for the two complications. Understanding the mechanism for avoiding these complications may be important to avoiding them, as we move to a lower risk population where complication free results are even more important. Funding Acknowledgement Type of funding sources: None.

Feasibility, efficacy and safety of transbrachial access for interventional therapy on paravalvular leak post surgical valve replacement

Objective: To investigate the feasibility, efficacy and safety of transbrachial access for interventional therapy on prosthetic paravalvular leak (PVL) post surgical valve replacement. Methods: This is a retrospective study. Patients with PVL after surgical valve replacement who underwent interventional therapy via the brachial artery approach in Structural heart disease center of Fuwai hospital between August 2017 and October 2019, were included. All patients underwent puncture of the brachial artery under local anesthesia, angiography and transcatheter closure procedure were performed. The procedure was performed under transthoracic echocardiography (TTE) guidance. Baseline data, operation data and pre-and post-operative TTE examination results were collected and analyzed. Postoperative complications were recorded and operational adverse events were obtained during follow up in the outpatient department after discharge. The operation success rate was calculated, which was defined as the degree of perivalvular regurgitation decrease by 1 grade and above according to TTE without interfering the valve movement and coronary artery blood flow within 30 days after occluder placement. Results: A total of 10 patients were enrolled in this study, the mean age was (57.5±14.6) years, and 6 patients were males. There were 7 cases with aortic PVL, and 3 cases with mitral PVL. Except for one patient who was converted to the femoral vein-transseptal approach, the other 9 patients were successfully implanted with the devices via the brachial artery approach. The operation time was (103.3±34.0) minutes, and there was no need for rigorous bed rest after the operation. The median hospital stay was 7.5 (3.0, 9.8) days. The operation success rate was 9/10 via the brachial artery approach. The differences in the degree of perivalvular regurgitation, New York Heart Association (NYHA) classification, left ventricular end diastolic diameter and left atrial diameter before and after operation were statistically significant (all P<0.05). One case developed new hemolysis with renal insufficiency on the second day after procedure and discharged after successful dialysis. Another case experienced complication of brachial artery pseudoaneurysm after procedure and discharged after successful treatment with thrombin injection. The mean follow-up time was (14.3±7.9) months. During the follow-up, NYHA classification remained as Ⅰ/Ⅱ in 9 patients, no operational adverse events were observed. Conclusions: Transbrachial access for interventional therapy on PVL post surgical valve replacement is a feasible, effective, and safe procedure. It has the advantages of simplifying the operation process and reducing postoperative bed rest time.

Composite Metric for Benchmarking Site Performance in Transcatheter Aortic Valve Replacement: Results From the STS/ACC TVT Registry.

Transcatheter aortic valve replacement (TAVR) is a transformative therapy for aortic stenosis. Despite rapid improvements in technology and techniques, serious complications remain relatively common and are not well described by single outcome measures. The purpose of this study was to determine whether there is site-level variation in TAVR outcomes in the United States using a novel 30-day composite measure. We performed a retrospective cohort study using data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry to develop a novel ranked composite performance measure that incorporates mortality and serious complications. The selection and rank order of the complications for the composite was determined by their adjusted association with 1-year outcomes. Sites with risk-adjusted outcomes significantly more or less frequent than the national average based on a 95% probability interval were classified as performing worse or better than expected. The development cohort consisted of 52 561 patients who underwent TAVR between January 1, 2015, and December 31, 2017. Based on associations with 1-year risk-adjusted mortality and health status, we identified 4 periprocedural complications to include in the composite risk model in addition to mortality. Ranked empirically according to severity, these included stroke, major, life-threatening or disabling bleeding, stage III acute kidney injury, and moderate or severe perivalvular regurgitation. Based on these ranked outcomes, we found that there was significant site-level variation in quality of care in TAVR in the United States. Overall, better than expected site performance was observed in 25/301 (8%) sites, performance as expected was observed in 242/301 sites (80%), and worse than expected performance was observed in 34/301 (11%) sites. Thirty-day mortality; stroke; major, life-threatening, or disabling bleeding; and moderate or severe perivalvular leak were each substantially more common in sites with worse than expected performance as compared with other sites. There was good aggregate reliability of the model. There are substantial variations in the quality of TAVR care received in the United States and 11% of sites were identified as providing care below the average level of performance. Further study is necessary to determine structural, process-related, and technical factors associated with high- and low-performing sites.

Role of Cardiac CT in Pre-Procedure Planning for Transcatheter Mitral Valve Replacement

ObjectivesThis study sought to evaluate cardiac computed tomography (CCT) findings and their clinical impact among patients being considered for transcatheter mitral valve replacement (TMVR). BackgroundCCT is used to evaluate whether patients are candidates for TMVR, but limited data exist on the yield of such tests. MethodsPatients referred for pre-procedural CCT for TMVR planning in the context of failing mitral bioprosthetic valves, annuloplasty rings, and severe native valve disease with annular calcification were included in this study. CCT findings were analyzed to evaluate for suitability for TMVR. In the subset of patients who underwent TMVR, echocardiographic and procedural characteristics were recorded. ResultsAmong 80 patients who underwent pre-procedural CCT, the mean age was 71.8 ± 11.4 years, 60% were women, and the mean Society of Thoracic Surgeon score was 9.4 ± 6.7. Most cases were referred for valve-in-native annular calcification planning (n = 43), followed by valve-in-valve (n = 29), and valve-in-ring procedures (n = 8). A total of 51 (64%) patients did not undergo TMVR, 37 of whom had high-risk features identified on CCT. The most common reason for exclusion was related to large annular size, followed by heightened risk of left ventricular outflow tract (LVOT) obstruction. Among 29 patients (36%) who underwent TMVR, the 30-day mortality rate was 17%. Five patients experienced LVOT obstruction, 4 of whom were predicted by CCT. Following TMVR, 5 patients had at least moderate peri-valvular regurgitation. ConclusionsA minority of patients referred for TMVR planning ultimately undergo the procedure. CCT identifies unsuitable anatomy and leads to exclusion in a significant number of cases.

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

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

Midterm Outcomes for Valve-in-Valve Transcatheter Aortic Valve Replacement in the Failed Freestyle Bioprosthesis

Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) is acceptable in patients at high risk for reoperation. Studies suggest that ViV TAVR in stentless valves may be technically more challenging. This study sought to evaluate midterm outcomes for ViV TAVR in the degenerative Freestyle ((Medtronic, Minneapolis, MN)) stentless bioprosthesis. Between October 2014 and January 2019, 56 patients underwent ViV TAVR for a failed Freestyle valve at a single institution using a commercially available self-expanding transcatheter aortic valve. Patient baseline characteristics and clinical outcomes data were collected retrospectively. Valve Academic Research Consortium-2 definitions were applied. Mean patient age was 75 ± 8 years and The Society of Thoracic Surgeons mean risk score was 9% ± 8%. The predominant mode of Freestyle valve failure was regurgitation (77%), and 36 patients (64%) required urgent intervention for refractory acute heart failure. Device success using a self-expanding TAVR was 82%, with 6 cases (11%) requiring deployment of two transcatheter valves. There were 3 operative mortalities (5%). At 30-day follow-up, no patient had greater than moderate perivalvular regurgitation. Device success was higher in the later patients compared with patients done earlier (P= .02). Mean aortic valve gradients at 30 days and 1 year were 11 ± 8 and 9 ± 8 mm Hg, respectively. For patients alive beyond day 30, 3-year survival was 82%. Performing ViV TAVR in the Freestyle valve using a self-expanding transcatheter valve presents a technical challenge, but may be feasible with good midterm results. Procedural success is associated with an early hazard learning curve.

Transcatheter aortic valve implantation using the ACURATE neo in bicuspid and tricuspid aortic valve stenosis: a propensity-matched analysis of a European experience.

The aim of this study was to assess the performance of a self-expanding valve in bicuspid aortic valve (BAV) stenosis. An international registry included a total of 712 patients with aortic stenosis treated with the ACURATE neo in bicuspid (n=54; 7.5%) or tricuspid (n=658; 92.4%) anatomy. The overall mean age was 81±5.6 years. At baseline, no significant differences were found between the two groups. BAV more frequently required both predilatation (94.4% vs. 78.1%, p=0.004) and post-dilation (57.4% vs. 38.7%, p=0.007). Moderate perivalvular regurgitation was more frequently found in patients with BAV (7.4% vs. 3.18%, p=0.0001). After propensity score matching (PSM), the rate of predilation and post-dilation was confirmed to be higher in the BAV group (94.4% vs. 66.6%, p=0.001, and 57.4% vs. 37.1%, p=0.034, respectively), while the incidence of moderate perivalvular regurgitation was similar between the two groups (BAV 3.1% vs. 5.5% in tricuspid anatomy, p=0.734). In unmatched cohorts, the 30-day outcome showed a higher rate of stroke in the BAV group (7.4% vs. 1.8%, p=0.001). After adjustment for PSM quintiles, the rate of stroke resulted in being similar (odds ratioadj 1.20, 95% confidence interval [CI]: 0.81-1.76, p=0.819). The other 30-day clinical endpoints were similar between the two populations. This preliminary analysis shows that the use of the ACURATE neo in bicuspid aortic valves is feasible and has acceptable 30-day outcomes. Larger studies are needed to confirm our preliminary findings.

TAVR in Patients with a Low STS Score: A Cohort Study with a Mean Follow Up of 2 Years.

Partner 2 and SURTAVI trials (mean STS score of 5.8 and 4.5) support extending TAVR into the intermediate risk group. We present our results of TAVR in a group with mean STS score of 2.9 and 2 year follow up. This is a prospective cohort study of 46 consecutive patients undergoing TAVR between 2011 and 2016. All patients had severe symptomatic AS. Age, functional status, coronary disease, co-morbidity and imaging parameters were assessed. Patients were followed up for 12-60 months. 46 patients with a mean age of 75 years were enrolled. Mean EF 56%, mean MG 52 mm Hg and mean PG 87 mm Hg. The mean STS score was 2.9. Forty-two underwent transfemoral and 4 transaortic TAVR. Forty-five of 46 valves were implanted successfully. One patient had moderate perivalvular regurgitation (PVR). Post-procedure mean MG was 11 mm Hg. There was one procedure related stroke and one intraprocedural death. Five patients (10.8%) required a permanent pacemaker. 30-day mortality was 2 of 46 (4.3%). Mean follow up was 28 months. Mean MG at 2 years was 12 mm Hg. Late cardiac mortality occurred in 1 patient. TAVR in this group with a low STS score was successful with excellent valve performance. Although the STS score identifies intermediate and high risk patients, it does not account for the overall frailty and limited mobility of many elderly patients placing them at a higher surgical risk despite their low STS scores. A scoring system that captures all such factors is required. Finally, a large scale randomized trial with long term follow up determining the validity of TAVR in truly low risk individuals is necessary.

Treatment with Corticosteroid and/or Immunosuppressive Agents before Surgery can Effectively Improve the Surgical Outcome in Patients with Takayasu's Arteritis

ABSTRACTObjective: To analyze the clinical outcome of corticosteroid and/or immunosuppressive treatment preoperatively in patients with Takayasu's arteritis. Patients and Methods: Forty-six patients with Takayasu's arteritis who received cardiovascular surgery between January 2010 and December 2015 in Beijing Anzhen Hospital were enrolled in this study. Their clinical characteristics, preoperative drug therapy, surgical treatment, and pathological examination results were retrospectively analyzed for the effect of drugs on outcome of the surgery. Results: All 8 patients with active disease prior to surgery had postoperative complications including one death due to stubborn perivalvular regurgitation induced heart failure during the perioperative period. Among 38 patients without active disease prior to surgery, only 4 patients (10.5%) had postoperative complications. Thirty-four patients showed symptomatic relief in the perioperative period, of whom 23 patients treated with corticosteroid and/or immunosuppressive agents preoperatively. Conclusion: The surgery can effectively improve the symptoms of patients with Takayasu's arteritis. Active disease of Takayasu's arteritis markedly increased risk for postoperative complication and resulted in poor outcome of the surgery. Treatment with corticosteroid and/or immunosuppressive agents before surgery can effectively control the patient's condition, improve the rate of remission, and effectively reduce the incidence of postoperative complications.

Transcatheter Aortic Valve Implantation.

Severe aortic stenosis (AS) is a life-threatening condition when left untreated. Aortic valve replacement (AVR) is the gold standard treatment for the majority of patients; however, transcatheter aortic valve implantation/replacement (TAVI/TAVR) has emerged as the preferred treatment for high-risk or inoperable patients. The concept of transcatheter heart valves originated in the 1960s and has evolved into the current Edwards Sapien and Medtronic CoreValve platforms available for clinical use. Complications following TAVI, including cerebrovascular events, perivalvular regurgitation, vascular injury, and heart block have decreased with experience and evolving technology, such that ongoing trials studying TAVI in lower risk patients have become tenable. The multidisciplinary team involving the cardiac surgeon and cardiologist plays an essential role in patient selection, procedural conduct, and perioperative care.

Abstract 20183: Intraprocedural C-Arm CT Imaging Identifies Incomplete Stent Frame Expansion in Self-Expanding Aortic Valve Prostheses Associated With Perivalvular Aortic Regurgitation

Introduction: Transcatheter aortic valve replacement has revolutionized the treatment of severe aortic stenosis, but post implantation perivalvular aortic regurgitation may result in increased mortality. Hypothesis: The purpose of this study was to identify structural abnormalities in the frame of self-expanding aortic valve prostheses (CoreValve®, Medtronic, Minneapolis, MN) immediately following implantation and evaluate their relationship to subsequent perivalvular aortic regurgitation severity. Methods/Results: After implantation of CoreValve, 14 patients with evidence of frame deformation by fluoroscopy underwent intraprocedural C-arm CT imaging (syngo DynaCT®, Siemens Medical Solutions, USA) acquired using 5-s, 200° rotation under breath-hold and rapid right ventricular pacing (120-140bpm). CT-like multi-planar reconstructions (Figure) were performed; perimeter (P), maximum (Dmax) and minimum (Dmin) diameters of the CoreValve frame were measured at multiple levels (0mm, 8mm, 16mm) orthogonal to the longitudinal axis. Ellipticity index (EI) was measured as Dmax divided by Dmin. Color Doppler transthoracic echo was performed the day following valve implantation to assess perivalvular regurgitation. One-way ANOVA demonstrated that degree of perivalvular aortic regurgitation was significantly related to valve frame perimeter underexpansion at the inferior margin of the frame (20.8% [17.2-25.7%], p=0.011) and increased ellipticity index both at the 8mm above the edge of the frame (1.4, [1.3-1.5], p=0.012) and 16mm above the edge of the frame (1.4, [1.3-1.5], p=0.038). Conclusions: Intraprocedural DynaCT effective at determining aortic valve frame deformations in 3D, which was associated with increased perivalvular aortic regurgitation, and may provide a method for risk stratifying post-implantation aortic regurgitation and need for additional procedural maneuvers such as post-stent dilation or additional revalving.

Complete and partly unexpected diagnostic findings at 18F-FDG-PET/CT scanning in patients with suspected prosthetic valve endocarditis

A 76-year-old male with previous aortic valve replacement presented with intermittent fever. No apparent source of infection was found at clinical inspection. Blood cultures were positive for Streptococcus anginosus . Infective endocarditis was suspected and transoesophageal echocardiography (TOE) was performed. The exam showed a mildly degenerated bioprosthesis with thickened leaflets; there was an increased gradient (mean gradient 22 mmHg); neither valvular nor perivalvular regurgitation was identified. These findings were suspect for …

大動脈炎症候群を伴った大動脈弁置換術後弁周囲逆流の1例

大動脈炎症候群を伴った大動脈弁置換術後弁周囲逆流の1例

TCT-91 Peri-valvular Aortic Regurgitation in Balloon-expendable and Self-expendable TAVI procedures: Predictors and Impact on clinical outcome - Insights from the FRANCE2 Registry

A significant perivalvular aortic regurgitation (AR) is observed in 10-20% after a successful TAVI procedure. The prognostic value and the predictors of such complication in Balloon-expendable (BE) and Self-expendable (SE) TAVI procedures remain unclear. 2,769 patients consecutive with a successful

TCT-827 Interaction Between Perivalvular aortic regurgitation and delivery approach: Impact on clinical outcome after TAVI - Insights from the France 2 Registry

TCT-827 Interaction Between Perivalvular aortic regurgitation and delivery approach: Impact on clinical outcome after TAVI - Insights from the France 2 Registry

Transcatheter aortic valve implantation: Our vision of the future

Transcatheter aortic valve implantation (TAVI), introduced 10 years ago by Alain Cribier, has now been performed in more than 50,000 patients worldwide. Our vision of the main directions for the future are fourfold. Firstly, the 'Heart Team' is and will remain, essential for patient selection and the performance of the procedure. Careful training and controlled diffusion of the technique to medico-surgical centres are also keys to success. Secondly, patient selection must be refined, in order to predict the risk of surgery and that of TAVI. The technique is currently limited to very high-risk patients or those with contraindications to surgery. It will be extended to include lower risk patients once there are adequate trial data, the safety of the procedure has been improved and better knowledge of long-term outcomes from the procedure has been obtained. Thirdly, the procedure will be simplified, and should also be safer with an expected decrease in the occurrence of strokes, vascular complications and perivalvular regurgitation. Fourthly, the devices will also improve, with the addition of the potential for repositioning and improvement in durability. The role of imaging with the use of multimodality techniques will no doubt increase and ease the efficacy and safety of the procedure. Overall, the use of TAVI will undoubtedly increase over time, enabling a larger number of patients with severe aortic stenosis to be treated in an effective and safe way, in complement to surgical aortic valve replacement.

Prosthetic valve endocarditis caused by Staphylococcus capitis: report of 4 cases

Although Staphylococcus capitis is considered to be a rare causative organism for prosthetic valve endocarditis, we report 4 such cases that were encountered at our hospital over the past 2 years. Case 1 was a 79-year-old woman who underwent aortic valve replacement with a bioprosthetic valve and presented with fever 24 days later. Transesophageal echocardiography revealed an annular abscess in the aorto-mitral continuity and mild perivalvular regurgitation. We performed emergency surgery 5 days after the diagnosis of prosthetic valve endocarditis was made. Case 2 was a 79-year-old woman presenting with fever 40 days after aortic valve replacement with a bioprosthesis. Transesophageal echocardiography showed vegetation on the valve, and she underwent urgent surgery 2 days after prosthetic valve endocarditis was diagnosed. In case 3, a 76-year-old man presented with fever 53 days after aortic valve replacement with a bioprosthesis. Vegetation on the prosthetic leaflet could be seen by transesophageal echocardiography. He underwent emergency surgery 2 days after the diagnosis of prosthetic valve endocarditis was made. Case 4 was a 68-year-old woman who collapsed at her home 106 days after aortic and mitral valve replacement with bioprosthetic valves. Percutaneous cardiopulmonary support was started immediately after massive mitral regurgitation due to prosthetic valve detachment was revealed by transesophageal echocardiography. She was transferred to our hospital by helicopter and received surgery immediately on arrival. In all cases, we re-implanted another bioprosthesis after removal of the infected valve and annular debridement. All patients recovered without severe complications after 2 months of antibiotic treatment, and none experienced re-infection during 163 to 630 days of observation. Since the time interval between diagnosis of prosthetic valve endocarditis and valve re-replacement ranged from 0 to 5 days, early surgical removal of the infected prosthesis and an appropriate course of antibiotics were attributed to good clinical outcomes in our cases.

673 Hypercholesterolemia is associated with increased incidence of bioprosthetic valve degeneration

673 Hypercholesterolemia is associated with increased incidence of bioprosthetic valve degeneration

“Flap Valve Phenomenon” Limiting Aortic Regurgitation in Prosthetic Valve Dehiscence

The authors describe the case of a 52-year-old man with a history of supra-annular mechanical aortic valve replacement who presented with fever and abdominal pain. He was found to have an abdominal wall abscess. Subsequent transesophageal echocardiography revealed dehiscence of his mechanical aortic valve, supporting a diagnosis of prosthetic valve endocarditis. Transesophageal echocardiography demonstrated that the dehisced aortic valve rocked on a hinge point, mimicking the motion of a flap valve. As the prosthetic valve rose with systole, it permitted flow into the aorta and, falling back in diastole, formed enough of a seal against the wall of the aortic annulus to limit aortic insufficiency. This "flap valve phenomenon" resulted in minimal perivalvular regurgitation, and the patient remained hemodynamically stable without heart failure before valve replacement.

Transcatheter Repair of Perivalvular Regurgitation

Hemodynamically significant perivalvular regurgitation affects about 1.5% of all prosthetic valve implants. Reoperation carries increased risk--especially in the setting of concomitant comorbidities of left ventricular dysfunction, prior coronary artery bypass grafts, renal dysfunction, and advanced age. Transcatheter closure of the perivalvular regurgitant channel using a variety of occluders has been available for several years; however, recent improvements in technology and technique have made this therapy more effective and available to a wider group of patients. This article describes the recent advances and the state of the art of this therapy.