Severe Paravalvular Regurgitation Research Articles

Transcatheter Aortic Valve Replacement for Isolated Aortic Regurgitation Using a New Self-Expanding TAVR System

BackgroundPatients with severe aortic regurgitation (AR) are often not considered for surgery because of increased surgical risk. Because of unique anatomical characteristics among patients with AR, interventional treatment options are limited, and implantation results are inconsistent compared with those among patients with aortic stenosis. ObjectivesThe authors describe the initial commercial experience of the first Conformité Européenne–marked transfemoral transcatheter aortic valve replacement system (JenaValve Trilogy [JV]) for the treatment of patients with AR. MethodsThis multicenter registry included 58 consecutive patients from 6 centers across Germany. Transcatheter aortic valve replacement was performed with the JV system for isolated severe and symptomatic AR. Patient characteristics, primary implantation outcomes, and valve performance up to 30 days were analyzed using Valve Academic Research Consortium 3 definitions. ResultsThe mean patient age was 76.5 ± 9 years, with a mean Society of Thoracic Surgeons score of 4.2% ± 4.3%. Device success was achieved in 98% of patients. The mean gradient was 4.3 ± 1.6 mm Hg, and no moderate or severe paravalvular regurgitation occurred. No conversion to open heart surgery or valve embolization was reported. There were no major vascular complications or bleeding events. The rate of new permanent pacemaker implantation was 19.6%. At 30 days, 92% of the patients were in NYHA functional class I or II, and the 30-day mortality rate was 1.7%. ConclusionsTreatment of patients with severe symptomatic AR using the transfemoral JV system is safe and effective. Given its favorable hemodynamic performance and low complication rates, this system may offer a new treatment option for patients with AR not suitable for surgery.

Chronological comparison of TAVI and SAVR stratified to surgical risk: a systematic review, meta-analysis, and meta-regression

ABSRACT Background Transcatheter aortic valve implantation (TAVI) has been established as a reasonable alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis. However, long-term outcomes including valve durability and the need for reintervention are unanswered, especially in younger patients who tend to be low surgical risk. We performed a meta-analysis comparing clinical outcomes after TAVI and SAVR over 5 years stratified to low, intermediate, and high surgical risks. Methods We identified propensity score-matched observational studies and randomised controlled trials comparing TAVI and SAVR. Primary outcomes, including all-cause mortality, moderate or severe aortic regurgitation, moderate or severe paravalvular regurgitation, pacemaker placement, and stroke, were extracted. Meta-analyses of outcomes after TAVI compared to SAVR were conducted for different periods of follow-up. Meta-regression was also performed to analyse the correlation of outcomes over time. Results A total of 36 studies consisting of 7 RCTs and 29 propensity score-matched studies were selected. TAVI was associated with higher all-cause mortality at 4–5 years in patients with low or intermediate surgical risk. Meta-regression time demonstrated an increasing trend in the risk of all-cause mortality after TAVI compared with SAVR. TAVI was generally associated with a higher risk of moderate or severe aortic regurgitation, moderate or severe paravalvular regurgitation, and pacemaker placement. Conclusions TAVI demonstrated an increasing trend of all-cause mortality compared with SAVR when evaluated over a long-term follow-up. More long-term data from recent studies using newer-generation valves and state-of-the-art techniques are needed to accurately assign risks.

Prevention and management of paravalvular regurgitation after transcatheter aortic valve implantation.

Management of paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI). Most patients with mild PVR can be managed medically with periodic imaging to detect any increase in regurgitant severity. In some patients with moderate to severe or severe PVR, medical therapy may be possible using guideline-directed medical therapy for heart failure or haemolytic anaemia. When intervention is needed, surgical aortic valve replacement (SAVR) may be considered, but many of these patients may be high risk for surgery or prefer to avoid surgical intervention. Transcatheter options include a vascular occluder device, a redo TAVI with placement of a second transcatheter valve (TAV-in-TAV), or balloon dilation of the initial TAVI valve.

Presence of Moderate or Severe Regurgitation after Transcatheter Aortic Valve Implant with the Cusp Overlap Strategy

Background: The aim of this study is to whether higher transcatheter aortic valve implantation (TAVI) with self-expandable valves using the right and left cusp overlap strategy (Cusp Overlap, COVL) is associated with a lower incidence of moderate or severe paravalvular regurgitation (PVR), compared with the conventional strategy (CON). Methods: A total of 206 consecutive patients undergoing TAVI with self-expandable valves between August 2019 and May2022 were analyzed. The CON technique was used in the first 101 patients (49%) and COVL was used in 105 (51%). The primary endpoint (PEP) was the presence of moderate or severe paravalvular regurgitation at 30 days. Results: There were no clinical differences between the groups in terms of mean age, sex or comorbidities, except for a trend towards more patients with diabetes and previous percutaneous coronary intervention in the COVL group. The STS score was greater in the COVL group (6.9 ± 2.2 vs. 5.8 ± 2.4 in the CON group; p = 0.01). There was no difference in the PEP at 30 days with 2% incidence of moderate PVR in the CON group and 0.9% in the COVL group, and none of them presented severe PVR. There were no differences in mortality, myocardial infarction, coronary artery obstruction, stroke, major bleeding or vascular complications. The need for permanent pacemaker was lower with the COVL strategy (6.7% vs. 17.8%, p = 0.01) and a new left bundle branch block occurred in 5.7% vs. 12.9% (p = 0.07). Conclusions: In this single-center series, the strategy of high transcatheter aortic valve implantation using the COVL strategy showed no difference in the presence of moderate or severe regurgitation compared with the conventional strategy, with no differences in complications, and was associated with a lower need for definitive pacemaker and with a trend towards lower incidence of left bundle branch block at 30 days.

Anatomical morphology of the aortic valve in Chinese aortic stenosis patients and clinical results after downsize strategy of transcatheter aortic valve replacement.

The study aimed to describe the aortic valve morphology in Chinese patients underwent transcatheter aortic valve replacement (TAVR) for symptomatic severe aortic stenosis (AS), and the impact of sizing strategies and related procedural outcomes. Patients with severe AS who underwent TAVR were consecutively enrolled from 2012 to 2019. The anatomy and morphology of the aortic root were assessed. "Downsize" strategy was preformed when patients had complex morphology. The clinical outcomes of patients who performed downsize strategy were compared with those received annular sizing strategy. The primary outcome was device success rate, and secondary outcomes included Valve Academic Research Consortium-3 clinical outcomes variables based on 1-year follow-up. A total of 293 patients were enrolled. Among them, 95 patients (32.4%) had bicuspid aortic valve. The calcium volume (Hounsfield Unit-850) of aortic root was 449.90 (243.15-782.15) mm 3 . Calcium is distributed mostly on the leaflet level. Downsize strategy was performed in 204 patients (69.6%). Compared with the patients who performed annular sizing strategy, those received downsize strategy achieved a similar device success rate (82.0% [73] vs . 83.3% [170], P = 0.79). Aortic valve gradients (downsize strategy group vs . annular sizing group, 11.28 mmHg vs. 11.88 mmHg, P = 0.64) and percentages of patients with moderate or severe paravalvular regurgitation 2.0% (4/204) vs . 4.5% (4/89), P = 0.21) were similar in the two groups at 30 days after TAVR. These echocardiographic results were sustainable for one year. Chinese TAVR patients have more prevalent bicuspid morphology and large calcium volume of aortic root. Calcium is distributed mostly on the leaflet level. Compare with annular sizing strategy, downsize strategy provided a non-inferior device success rate and transcatheter heart valve hemodynamic performance in self-expanding TAVR procedure.

210 TAVI WITH SAPIEN 3 ULTRA AND ACURATE NEO2: OUTCOMES FROM A HIGH VOLUME CENTER

Abstract Background Latest iterations of devices for transcatheter aortic valve implantation (TAVI) have brought refinements to further improve patients outcomes, but comparisons of balloon-expandable Sapien 3 ULTRA (ULTRA) and self-expanding Acurate Neo 2 (NEO2) valves are lacking. Objectives To compare hemodynamic and clinical outcomes of patients undergoing TAVI with ULTRA or NEO 2 devices. Methods Patients undergoing TAVI with ULTRA and NEO 2 and enrolled in the REPLACE Registry from June 2019 to July 2022 (n=174) were analyzed. The primary efficacy and safety outcomes were VARC-3 device success and early safety, respectively. Secondary outcomes included technical success, 30-day clinical outcomes and echocardiographic device performance. Results A total of 119 patients receiving ULTRA (68.4%) and 55 receiving NEO 2 (31.6%) were compared. The primary efficacy (90.8% vs. 87.3%, for ULTRA and NEO2 respectively, p=0.483) and safety (87.4% vs. 85.5%, for ULTRA and NEO2 respectively, p=0.725) outcomes did not differ between patients receiving ULTRA or NEO 2 transcatheter aortic valves. On post-TAVI echocardiography, no cases of severe PVR were detected. The rate of mild-to-moderate paravalvular regurgitation (PVR) was lower in the ULTRA group (0.9% vs. 6.1%, p=0.002), with similar mean transvalvular gradients between the study groups (median 10 vs. 8.5 mmHg, for ULTRA and NEO2 respectively, p=0.11). Conclusions In this comparison, device success rates were high with both new-generation devices, with overall low rates of adverse events at 30 days after TAVI. Very low PPI rates were reported with both devices. PVR rates were low, but higher in patients receiving NEO 2.

Minimalist transcatheter aortic valve replacement misses paravalvular regurgitation:Incidence and echocardiographic distribution of missed paravalvular regurgitation.

Paravalvular regurgitation (PVR) may be missed intraoperatively with transthoracic echocardiography (TTE) guided minimalist TAVR. We sought to determine the incidence and echocardiographic distribution of PVR missed on intra-op TTE, but detected on predischarge TTE. From July 2015 to 2020, 475 patients with symptomatic severe native aortic stenosis underwent TTE-guided minimalist TAVR. Missed PVR was defined as predischarge PVR that was ≥1 grade higher than the corresponding intra-op PVR severity. PVR was classified as anterior or posterior on the four standard TTE views; parasternal short-axis (PSAX), parasternal long-axis (PLAX), apical 3-chamber (A3C), and 5-chamber (A5C). Location-specific risk of missed PVR was then determined. Mild or greater PVR was seen in 55 (11.5%) cases intra-op and 91 (19.1%) at predischarge, with no severe PVR. Among the 91 patients with ≥mild predischarge PVR, missed PVR was present in 42 (46.2%). Compared to the corresponding anterior jets, missed PVR rate was significantly higher for posterior jets in PLAX (62.5% vs. 25.0%, p = 0.005), A5C (56.9% vs. 25.0%, p = 0.009), PSAX (66.7% vs. 24.3%, 0.001), but not A3C (58.5% vs. 40.0%, p = 0.28). Intraoperative TTE-guided minimalist TAVR either misses nearly half of ≥mild PVR or underestimates PVR by ≥1 grade when compared to predischarge TTE. Posterior PVR jets are more likely to be missed. Transesophageal echo guidance may help minimize missing PVR. Further studies are warranted.

Abstract 9991: Index Case of Prosthetic Mitral Valve Dehiscence Secondary to SARS CoV 2 Virus: Histopathologic Evidence of T-cell Mediated Injury

Introduction: SARS-Cov-2 virus has been shown to inflict damage on native cardiac valvular tissue. We present the index case of prosthetic mitral valve (MV) dehiscence secondary to SARS-Cov-2 virus as evidenced by histopathologic analysis of peri-valvular annular tissue . Case: 63-year-old male with history of MV replacement 2 years ago presented with complaint of dyspnea for 2 weeks. He was asymptomatic on a cardiology appointment a month ago and had an unremarkable transthoracic echocardiography (TTE) at that time. On arrival, he was hypoxic to 80% on room air and chest exam revealed bibasilar crackles. Complete blood count and electrolytes were within normal ranges. He tested positive for SARS-Cov-2 virus RNA and had a recent family history of COVID-19. Chest X-ray revealed bilateral pulmonary vascular congestion. He was given supplemental oxygen through nasal cannula with improvement in pulse oximetry. Repeat TTE revealed mitral paravalvular leak with suspicion for prosthetic dehiscence. Transesophageal echocardiogram showed multiple jets of severe paravalvular regurgitation and disruption of the MV apparatus. No vegetations were detected on echocardiography. He underwent a pre-operative right heart catheterization which confirmed severe MV regurgitation with pulmonary artery (PA) capillary wedge pressure of 45mmHg (Normal: <12) and a PA pressure of 40mmHg (Normal:<20). Intra-operatively, we found near-complete dehiscence of prosthetic MV with surrounding annular calcifications. Our patient underwent surgical MV replacement with a biosynthetic valve. Histopathologic analysis of the annular tissue revealed myxomatous degeneration and an inflammatory infiltrate of CD4 T helper cells consistent with subacute to chronic inflammation. Of note, neutrophils were not detected which usually signify acute bacterial endocarditis. Tissue and blood cultures remained sterile. Our patient improved hemodynamically after MV replacement and was discharged home in stable condition. Conclusion: We propose that SARS-Cov-2 virus may cause prosthetic MV dehiscence through CD4 T cell-mediated damage to annular tissue. Such cases would require surgical valve replacement to manage the resulting hemodynamic compromise.

Left ventricular outflow tract pseudoaneurysms and severe paravalvular aortic regurgitation treated by percutaneous approach in a Marfan syndrome patient

A 66-year-old male with a history of Marfan syndrome and resolved infective endocarditis was found to have shortness of breath after a previous aortic valve replacement in 2010. Several severe paravalvular leaks were seen on imaging, and left ventricular outflow tract pseudoaneurysms were identified as the cause of his symptoms which warranted treatment. Due to this patient’s risk of surgical intervention, a retrograde transaortic approach was used.

Transcatheter Aortic Valve Replacement With the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry

BackgroundThe latest iterations of devices for transcatheter aortic valve replacement (TAVR) have brought refinements to further improve patient outcomes. ObjectivesThis study sought to compare early outcomes of patients undergoing TAVR with the self-expanding (SE) Evolut PRO/PRO+ (Medtronic, Inc) or balloon-expandable (BE) Sapien 3 ULTRA (Edwards Lifesciences) devices. MethodsThe OPERA-TAVI (Comparative Analysis of Evolut PRO vs Sapien 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry collected data from 14 high-volume centers worldwide on patients undergoing TAVR with SE or BE devices. After excluding patients who were not eligible for both devices, patients were compared using 1:1 propensity score matching. The primary efficacy and safety outcomes were Valve Academic Research Consortium-3 device success and early safety, respectively. ResultsAmong 2,241 patients eligible for the present analysis, 683 pairs of patients were matched. The primary efficacy outcome did not differ between patients receiving SE or BE transcatheter aortic valves (SE: 87.4% vs BE: 85.9%; P = 0.47), but the BE device recipients showed a higher rate of the primary safety outcome (SE: 69.1% vs BE: 82.6%; P < 0.01). This finding was driven by the higher rates of permanent pacemaker implantation (SE: 17.9% vs BE: 10.1%; P < 0.01) and disabling stroke (SE: 2.3% vs BE: 0.7%; P = 0.03) in SE device recipients. On post-TAVR echocardiography, the rate of moderate to severe paravalvular regurgitation was similar between groups (SE: 3.2% vs BE: 2.3%; P = 0.41), whereas lower mean transvalvular gradients were observed in the SE cohort (median SE: 7.0 vs BE: 12.0 mm Hg; P < 0.01). ConclusionsThe OPERA-TAVI registry showed that SE and BE devices had comparable Valve Academic Research Consortium-3 device success rates, but the BE device had a higher rate of early safety. The higher permanent pacemaker implantation and disabling stroke rates in SE device recipients drove this composite endpoint.

Risk and Timing of Noncardiac Surgery After Transcatheter Aortic Valve Implantation

Noncardiac surgery after transcatheter aortic valve implantation (TAVI) is a clinical challenge with concerns about safety and optimal management. To evaluate perioperative risk of adverse events associated with noncardiac surgery after TAVI by timing of surgery, type of surgery, and TAVI valve performance. This cohort study was conducted using data from a prospective TAVI registry of patients at the tertiary care University Hospital in Bern, Switzerland. All patients undergoing noncardiac surgery after TAVI were identified. Data were analyzed from November through December 2021. Timing, clinical urgency, and risk category of noncardiac surgery were assessed among patients who had undergone TAVI and subsequent noncardiac surgery. A composite of death, stroke, myocardial infarction, and major or life-threatening bleeding within 30 days after noncardiac surgery. Among 2238 patients undergoing TAVI between 2013 and 2020, 300 patients (mean [SD] age, 81.8 [6.6] years; 144 [48.0%] women) underwent elective (160 patients) or urgent (140 patients) noncardiac surgery after TAVI and were included in the analysis. Of these individuals, 63 patients (21.0%) had noncardiac surgery within 30 days of TAVI. Procedures were categorized into low-risk (21 patients), intermediate-risk (190 patients), and high-risk (89 patients) surgery. Composite end points occurred within 30 days of surgery among 58 patients (Kaplan-Meier estimate, 19.7%; 95% CI, 15.6%-24.7%). There were no significant differences in baseline demographics between patients with the 30-day composite end point and 242 patients without this end point, including mean (SD) age (81.3 [7.1] years vs 81.9 [6.5] years; P = .28) and sex (25 [43.1%] women vs 119 [49.2%] women; P = .37). Timing (ie, ≤30 days from TAVI to noncardiac surgery), urgency, and risk category of surgery were not associated with increased risk of the end point. Moderate or severe prosthesis-patient mismatch (adjusted hazard ratio [aHR], 2.33; 95% CI, 1.37-3.95; P = .002) and moderate or severe paravalvular regurgitation (aHR, 3.61; 95% CI 1.25-10.41; P = .02) were independently associated with increased risk of the end point. These findings suggest that noncardiac surgery may be performed early after successful TAVI. Suboptimal device performance, such as prosthesis-patient mismatch and paravalvular regurgitation, was associated with increased risk of adverse outcomes after noncardiac surgery.

P395 INFECTIVE ENDOCARDITIS: A SUBTLE PRESENTATION

Abstract Background Infective endocarditis is still a serious and deadly disease. Despite improvements in its management, the diagnosis it is not always easy and thus it is still associated with high mortality and severe complications. This is especially true for patients with prosthetic valves, that have higher risk of developing infective endocarditis and more often associated with severe complications and a higher rate of mortality. Case Description A 75–years–old woman presented to the ED for persistent low–grade fever and mild dyspnoea. She had an aortic biologic prosthetic valve implanted the year before for severe aortic stenosis. She also complained a persistent back pain, present for about three months and irresponsive to pharmacological therapy and also physiotherapy. Getting back in time, she had been hospitalized few months before for genitourinary tract infection from multi–resistant E. faecalis, treated with antibiotic therapy and then discharged after few days. She underwent a transthoracic echocardiogram in ED that showed an apparently intraprosthetic moderate aortic regurgitation, never described in the previous cardiologic controls. In the strong suspect of endocarditis complicated by systemic embolization, she also underwent transoesophageal echocardiography, that showed dehiscence of the prosthetic valve with severe paravalvular abscess and regurgitation, without rocking motion of the prosthesis. A TC scan and then a spine MRI confirmed the presence of infectious spondylodiscitis, responsible for that persistent back pain. The patient was therefore urgently sent to cardiac surgery: a Bentall procedure (aortic valve and aortic root replacement) was performed. The patient, despite the severity of the sepsis and the cardiac endocarditis, survived the surgery and after 3 weeks of intensive care hospitalization was discharged and sent back to our Department for Cardiac Rehabilitation. Entering the ward, the patient was severely deconditioned, but after about 45 days of hospitalization she was discharged fit, with good functional capacity. Conclusion This case shows the subtle but serious evolution that usually controlled infections can have in patients with high risk of endocarditis, as patients with prosthetic valves. This underlines on one hand the importance of antibiotic prophylaxis in this subset of patients, on the other hand the role of multimodality imaging for diagnosis and management of infective endocarditis and its complications.

P326 SURGICAL VERSUS TRANSCATHETER AORTIC VALVE REPLACEMENT WITH NEWER GENERATION DEVICES IN REAL–WORLD PRACTICE: ONE–YEAR OUTCOMES FROM THE ITALIAN OBSERVANT STUDIES

Abstract Objective To compare the early and 1–year outcomes after transcatheter aortic valve replacement (TAVR) with new–generation devices over surgical replacement (SAVR) among patients with severe aortic stenosis (AS). Background TAVR is gaining acceptance for the treatment of lower risk patients with AS after several randomized and observational studies confirmed comparable early results to SAVR. On the other hand, clinical studies have shown that SAVR is still widely used in intermediate and high risk patients. There is need of data from large clinical registries to demonstrate the efficacy and safety of TAVR in the real–world setting, particularly after the introduction of new TAVR technology. Methods A total of 5706 AS patients who underwent SAVR and 2989 AS patients who underwent TAVR enrolled in the national, prospective OBSERVANT and OBSERVANT II studies, respectively in 2010–2012 and 2016–2018, were analyzed. Outcomes were adjusted using the propensity score matching. The primary outcomes of interest were all–cause mortality, major adverse cardiac and cerebrovascular events (MACCEs) and hospital readmission due to heart failure at 1–year. Secondary outcomes were major adverse events occurring during the index hospitalization. Results Among 1008 propensity score matched pairs, TAVR was associated with significantly lower 30–day mortality (1.8 vs. 3.5%, p = 0.020), stroke (0.8 vs. 2.3%, p = 0.005), acute kidney injury (0.6 vs. 8.2%, p &amp;lt; 0.001), infectious complications (3.8 vs. 6.5%, p = 0.006) and cardiogenic shock (1.4 vs. 5.1%, p &amp;lt; 0.001) compared to SAVR. Moderate–to–severe paravalvular regurgitation (5.9 vs. 2.0%, p &amp;lt; 0.001), major vascular complications requiring invasive treatment (2.2 vs. 0.1%, p &amp;lt; 0.001) and permanent pacemaker implantation (during the index hospitalization, 13.8 vs. 3.3%, p &amp;lt; 0.001) were more frequent after TAVR. At 1–year, TAVR was associated with lower risk of all–cause death (7.9 vs. 11.5%, p = 0.006), MACCE (12.0 vs. 15.8%, p = 0.011), readmission due to heart failure (10.8 vs. 15.9%, p &amp;lt; 0.001) and stroke (3.2 vs. 5.1%, p = 0.033) compared to SAVR. Conclusions In a real–world setting, patients with intermediate operative risk treated with newer generation TAVR devices had a low risk of major adverse events during the index–hospitalization and at 1–year follow–up. TAVR could become the treatment of choice for AS in the elderly provided that its durability is proved by long–term follow–up studies.

Rapid-deployment aortic valve replacement for patients with bicuspid aortic valve: a single-centre experience.

The benefit of rapid-deployment aortic valve replacement (RD-AVR) in patients with a bicuspid aortic valve (BAV) is controversial due to aortic root asymmetry and potential increased risk for valve dislocation and paravalvular leak. This study aimed to analyse the outcomes of surgical aortic valve replacement with a rapid-deployment bioprosthesis in patients with a BAV. Between May 2010 and December 2020, all consecutive patients who underwent RD-AVR at the Medical University of Vienna were included in our institutional database. Assessment of preoperative characteristics, operative outcomes, long-term survival and clinical events was performed. The outcomes of patients presenting with a native BAV were compared with a control group of patients with native tricuspid valve (TAV); reoperative aortic valve replacements were excluded. Out of 816 patients, who underwent RD-AVR at our institution, 107 patients with a BAV, mean age 68 (standard deviation: 8) years, were compared with a control group of 690 patients with a TAV, mean age 74 (standard deviation: 7) years; patients presenting with a BAV were significantly younger than patients with a TAV (P < 0.001). Concomitant procedures were performed in 44 (41.1%) patients in the BAV group and in 339 (49.1%) patients in the TAV group (P = 0.123); surgery of the ascending aorta was necessary in 24 (22.4%) in the BAV group, compared with 29 (4.2%) in the control group (P < 0.001). The 5-year cumulative incidence of moderate-to-severe paravalvular regurgitation in the BAV group was 10.7% [95% confidence interval (CI): 4.2-20.7%] and 3.9% (95% CI: 2.4-6.1%) in the TAV group (P = 0.057). Reoperation with valve explantation due to non-structural valve dysfunction at 5 years was 2.8% (95% CI: 0.5-8.8%) in the BAV group, compared to 1.9% (95% CI: 1.0-3.2%) in the TAV cohort (P = 0.89). The overall long-term survival rate in the BAV group was 92% (95% CI: 81-97%) at 5 years and 88% (95% CI: 73-95%), at 10 years, significantly better compared to the TAV group (log-rank test P = 0.002). RD-AVR can be performed in patients with a BAV with convincingly medical outcomes. However, a trend to increased frequency of moderate-severe paravalvular regurgitation was observed at long-term follow-up. Consequently, a different surgical approach, compared to tricuspid valves, with distinctly specific technical- and anatomical considerations and requirements, is recommended.

Successful delayed endovascular correction of migration of transcatheter aortic valve prosthesis in left ventricle outflow tract: case report

We report the successful endovascular correction of the migration of a transcatheter aortic valve prosthesis in the left ventricle outflow tract (LVOT). A 72-old man was underwent transcatheter aortic valve implantation (TAVI) at Almazov National Medical Research Centre for severe aortic stenosis. During the procedure, the self-expanding prosthesis dislocated 10–12 mm into the LVOT. The frame was optimised with the use of a balloon catheter, and aortic regurgitation I-II degree was achieved. However, on day 17 of hospitalisation, acute heart failure with episodes of asystole occurred as a result of severe paravalvular regurgitation; cardiopulmonary resuscitation was necessary. The prosthesis malpositioning was corrected by traction with endovascular snare devices. The patient was stable during the postprocedural period and discharged on day 31. Dislocation of self-expanding prostheses into the LVOT is a complication specific to TAVI that may quickly aggravate a patient’s condition; therefore, correction of valve malpositioning should be performed as soon as possible. The case reported here in an illustration of successful endovascular correction of dislocation performed with the snare traction technique. This bail-out approach can be used by interventional cardiologists in similar situations. Received 27 May 2021. Revised 29 July 2021. Accepted 30 July 2021. Funding: The study did not have sponsorship. Conflict of interest: Authors declare no conflict of interest. Contribution of the authorsLiterature review: A.D. Gorovaya, D.D. Zubarev, A.A. ProkhorikhinDrafting the article: A.D. Gorovaya, V.S. Krasnov, A.A. ProkhorikhinCritical revision of the article: A.D. Gorovaya, M.A. Chernyavskiy, A.A. ProkhorikhinSurgical treatment: D.D. Zubarev, V.S. Krasnov, A.A. ProkhorikhinFinal approval of the version to be published: A.D. Gorovaya, D.D. Zubarev, V.S. Krasnov, M.A. Chernyavskiy, A.A. Prokhorikhin

Sinus of Valsalva Dimension and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation

Ascending aortic root anatomy is routinely evaluated on pre-procedural multi-detector computed tomography (MDCT). However, its clinical significance has not been adequately studied. We aimed to investigate the impact of the sinus of Valsalva (SOV) dimension on clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). In a prospective TAVI registry, we retrospectively assessed SOV dimensions by pre-procedural MDCT. Patients were stratified according to tertiles of SOV diameter indexed to body surface area (SOVi). The primary endpoint was all-cause mortality at 1 year. Among 2066 consecutive patients undergoing TAVI between August 2007 and June 2018, 1554 patients were eligible for the present analysis. Patients in the large SOVi group were older (83 ± 6 vs 82 ± 6 vs 81 ± 6; P < .001) and had a higher Society of Thoracic Surgeons Predicted Risk of Mortality (6.3 ± 3.8 vs 5.1 ± 3.1 vs 4.9 ± 3.5; P < .001) than those in the other groups. Patients in the large SOVi group had a higher incidence of moderate or severe paravalvular regurgitation (11.9% vs 4.5% vs 3.5%; P < .001). At 1 year, a large SOVi was independently associated with an increased risk of mortality (HR: 1.62; 95% CI: 1.19-2.21; P=.002) and major or life-threatening bleeding (HR: 1.30; 95% CI: 1.02-1.65; P=.035). Dilatation of the aortic root at the SOV was associated with adverse outcomes after TAVI. The assessment of the aortic root should be integrated into the risk stratification system in patients undergoing TAVI.

Novel Pressure-Regulated Deployment Strategy for Improving the Safety and Efficacy of Balloon-Expandable Transcatheter Aortic Valves.

The authors propose a novel pressure-regulated method for balloon-expandable transcatheter heart valve (THV) deployment, aimed at optimizing prosthesis-annulus apposition while preventing significant tissue injury. The optimal method for balloon-expandable THV deployment remains debated. Current protocols are volume dependent, relying on under- and overfilling of the deployment apparatus. During deployment, the annular wall tension exerted by the expanding prosthesis is determined by maximal THV diameter and balloon pressure (Laplace's law). Three hundred thirty consecutive patients with severe native aortic stenosis who underwent TAVR with SAPIEN 3 THVs were included. One hundred and six patients were considered at high risk for annular rupture. THVs were deployed until reaching a predetermined balloon pressure. Postdilatation was performed to reduce mild or greater angiographic paravalvular regurgitation (PVR). Using a biomechanical model, annular wall stress was estimated for each case and assessed against rates of postdilatation, mild or greater PVR on transthoracic echocardiography, new permanent pacemaker placement or left bundle branch block, and annular rupture. Patients with wall stress >3 MPa had reduced postdilatation rate (P< 0.001) and reduced final PVR (P=0.014). Annular rupture occurred in 2 of 3 high-risk patients with wall stress >3.5 MPa (3.69 and 3.84 MPa); no rupture occurred in 95 high-risk patients with wall stress≤3.5 MPa. We defined a single target deployment pressure per THV size to ensure deployment within target wall stress levels of 3 to 3.5 MPa: 6.25 atm for 23-mm THVs, 5.5 atm for 26-mm THVs, and 5 atm for 29-mm THVs. Patients within this target range (n=136) had a 10.0% postdilatation rate, 12.7% mild PVR, and no moderate to severe PVR. The relationship between balloon filling volume and associated pressure and wall stress was inconsistent. Pressure-regulated THV deployment is a simple, reproducible, safe, and effective method, regardless of high-risk anatomical complexities.

Sinus of Valsalva Dimension and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation

Abstract Background Progressive dilatation of the aortic root is a common finding in patients with aortic stenosis. Although ascending aortic root anatomy is routinely evaluated on pre-procedural multi-detector computed tomography (MDCT), its clinical significance has not been adequately studied. Purpose We aimed to investigate the impact of the sinus of Valsalva (SOV) dimension on clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). Methods In a prospective TAVI registry, we retrospectively assessed SOV dimensions by pre-procedural MDCT. Patients were stratified according to tertiles of SOV diameter index to body surface area (SOVi). The primary endpoint was all-cause mortality at 1 year. Results Among 2066 consecutive patients undergoing TAVI between August 2007 and June 2018, 1554 patients were eligible for the present analysis. Patients in the large SOVi group were older (83±6 vs. 82±6 vs. 81±6; p&amp;lt;0.001) and had a higher Society of Thoracic Surgeons Predicted Risk of Mortality (6.3±3.8 vs. 5.1±3.1 vs. 4.9±3.5; p&amp;lt;0.001) than those in the other groups. Patients in the large SOVi group had a higher incidence of moderate or severe paravalvular regurgitation (11.9% vs. 4.5% vs. 3.5%; P&amp;lt;0.001). At 1 year, a large SOVi was independently associated with an increased risk of mortality (HR: 1.64; 95% CI: 1.21–2.23; P=0.001) and major or life-threatening bleeding (HR: 1.30; 95% CI: 1.03–1.65; P=0.029) after TAVI. Conclusions Dilatation of the aortic root at the SOV was associated with adverse outcomes after TAVI. The assessment of the aortic root should be integrated into the risk stratification system in AS patients undergoing TAVI. Funding Acknowledgement Type of funding sources: None. Figure 1Figure 2

Transcatheter Aortic Valve Replacement in Mixed Aortic Valve Disease: A Systematic Review and Meta-Analysis

BACKGROUND Utilization of transcatheter aortic valve replacement (TAVR) has expanded from high-risk patients to intermediate and select low-risk candidates with severe aortic stenosis (AS). TAVR is currently not indicated for patients with aortic insufficiency, and its outcomes in mixed aortic valve disease (MAVD) are unclear. METHODS A systematic search of PubMed, Medline, CINHAL and Cochrane databases was performed to identify studies comparing TAVR outcomes in patients with AS vs. MAVD. Primary outcomes included 30-day and late all-cause mortality, and paravalvular regurgitation (PVR). Secondary outcomes were major bleeding, vascular complications, device implantation success, permanent pacemaker and stroke. Pooled odds ratios (OR) and 95% confidence intervals (CIs) were calculated using Der Simonian-Laird random-effects model. RESULTS Six observational studies with 58,879 patients were included in the analysis. There was no significant difference in 30-day all-cause mortality (OR 1.03 [95% CI 0.92-1.15]; p = 0.63), however, MAVD group had higher odds of moderate to severe PVR (1.81 [1.41-2.31]; p<0.01). MAVD patients had lower odds of device implantation success (0.60 [0.40-0.91]; p = 0.02) while other secondary outcomes were similar in the two groups. CONCLUSIONS TAVR in MAVD is associated with increased odds of paravalvular regurgitation and lower odds of device implantation success when compared to severe aortic stenosis.

Evaluation of the safety and efficacy of transcatheter aortic valve replacement with domestic prostheses for patients with severely stenotic bicuspid aortic valve

Objective: To evaluate the safety and efficacy of transcatheter aortic valve replacement (TAVR) with domestic prostheses in patients with severely stenotic bicuspid aortic valve (BAV). Methods: This study was a prospective single-center non-randomized controlled study. Patients with symptomatic severe aortic stenosis (AS), who underwent TAVR with domestic prostheses at the First Affiliated Hospital of Air Force Medical University from January 2016 to April 2020 were consecutively included in our study. Patients were divided into BAV group and tricuspid aortic valve (TAV) group according to the aortic valve morphology. Baseline characteristics, procedural outcomes were compared between the two groups, and the primary endpoint was one-month all-cause mortality. Results: A total of 100 patients aged (69.8±8.9) years were enrolled, including 71 (71%) males. There were 51 cases in BAV group and 49 cases in TAV group. Compared with TAV group, patient in the BAV group was younger ((67.1±8.6) years vs. (72.7±8.4) years, P=0.002) and had larger ascending aortic diameter at proximal part ((39.7±5.7) mm vs. (36.0±4.2) mm, P<0.001), lower Society of Thoracic Surgeons-Predicted Risk of Mortality (STS-PROM) score (3.1 (1.9, 5.4) % vs. 5.9 (2.6, 12.3) %, P=0.002). In BAV group and TAV group, the incidence of 2nd prosthesis implantation was 15.7% (8/51) and 18.4% (9/49) (P=0.721), the incidence of moderate or severe paravalvular regurgitation was 2.0% (1/51) and 0 (P=1.000), the rate of device success was 82.4% (42/51) and 81.6% (40/49) (P=0.925), respectively. One-month all-cause mortality was 2.0% (1/51) and 10.2% (5/49) (P=0.108), respectively. Echocardiography showed that postprocedural mean pressure gradient (PGmean) was higher in the BAV group (13.0 (10.0, 16.0) mmHg vs. 9.0 (7.0, 14.0) mmHg, P=0.003) (1 mmHg=0.133 kPa), but the PGmean decrease post procedure as compared with that before TAVR was similar between the two groups ((36.7±16.6) mmHg vs. (36.2±17.5) mmHg, P=0.893). Conclusion: Favorable safety and efficacy are evidenced in patients with severely stenotic BAV undergoing TAVR with domestic prostheses.