Mild Paravalvular Regurgitation Research Articles

HAEMODYNAMIC FORCES ANALYSIS IN PATIENTS WITH PARAVALVULAR REGURGITATION AFTER TAVR: A PROPENSITY–SCORE MATCHED RETROSPECTIVE STUDY

Abstract Background Paravalvular regurgitation (PVR) after TAVR is a frequent complication, but its direct quantification and grading with conventional echocardiography is still limited by several factors. LV remodeling has still a role in the evaluation of PVR and its pathophysiology. Hemodynamic forces (HDF) analysis has emerged as a new tool to evaluate LV cardiac function in addiction to ejection fraction (EF) and global longitudinal strain (GLS). Aim of the study: To evaluate the difference in pre– and post–TAVR HDF in patients with preserved EF, using a propensity–matched analysis comparing patients with more than mild PVR to patients with mild or no PVR. Medis Ultrasound Suite software has been used for the estimation of HDF in order to differentiate earlier LV function modification between the two groups and its relationship with clinical outcomes. Material and Methods 25 patients from two European high–volume centers with more than mild PVR and coupled pre– and post–TAVR echocardiographic evaluation available for HDF analysis were retrospectively included, paired 1:2 with 50 patients, matched for characteristics that may influence HDF analysis and with mild or none PVR. Clinical outcome was a composite of heart failure (HF) valve–related hospitalization and worsening HF at 1 year. Results No significative differences were found at baseline clinical and echocardiography evaluation between the two groups: median age was 83 years, mean LVEF was 61%. Post–procedural echocardiographic evaluation was performed at 34 days after TAVR (IQR 5 – 50). Patients with significant PVR had higher LV end–diastolic volume (p = 0.044), lower endocardial GLS (p = 0.07) and lower LV diastolic apex–base longitudinal forces (LVD Apex–Base) (p = 0.045). The difference between LVD Apex–base pre– and post–TAVR was significantly lower in the significant PVR group (–0.8 vs 0.3%, p = 0.021). At Cox regression analysis, LV longitudinal force (LVLF) Ratio turned out to be predictive of clinical outcome (HR 1.11, 95CI 1.02 – 1.20, p = 0.017) in the overall population. Conclusion HDF analysis seems to be superior to conventional echocardiographic values of left ventricular cardiac function to detect the early effects of LV volume overload in patients with significant PVR after TAVR. Furthermore, in the overall population, LVLF Ratio predicts clinical outcomes and could be a promising new index to better evaluate the development of heart failure in patients with AS undergoing TAVR.

Paravalvular regurgitation after transcatheter aortic valve replacement: incidence, quantification, and prognostic impact

Abstract Transcatheter aortic valve replacement (TAVR) is standard of care in aortic stenosis (AS) with results comparable to surgical aortic valve replacement (SAVR). However, paravalvular regurgitation (PVR) is more common after TAVR. With the alteration of devices and implantation techniques, the incidence of moderate or more PVR has declined. Mild PVR is still common in around 30% of TAVR patients in low risk trials. Progression of AS causes myocardial hypertrophy and varying degrees of diastolic dysfunction which may cause heart failure even in combination with small volumes of PVR. Any degree of PVR is associated with increased risk of overall and cardiovascular mortality. Predictors of PVR are annular eccentricity, severe calcification of the aortic valve, bicuspid aortic valves, and type of prosthesis where balloon-expandable devices are associated with less PVR. PVR is diagnosed using echocardiography, aortic angiogram with or without videodensitometry, hemodynamic parameters, or cardiac magnetic resonance (CMR). PVR can be treated using post-dilation, interventional treatment using a vascular plug, or implantation of a second device. Successful post-dilation depends on balloon size which should at least be equal to or more than 95% of the mean annulus diameter. Implantation of a second device to reduce PVR is successful in approximately 90% of cases, either through lengthening of the sealing skirt in case of inadequate position or through further expansion of the index device. Implantation of a vascular plug can successfully reduce PVR and reduce mortality.

Multicentre experience of sutureless prostheses inside degenerated stentless aortic valves and bioroots.

Patients with failed stentless aortic prostheses are a challenging population to treat, as reoperative procedures may be complex and catheter-based treatments are associated with a high rate of procedural events. Reoperative surgery using sutureless valves may be an alternative. In this multicentre experience, we assess outcomes of 17 patients who underwent reoperative surgery using the Perceval valve (Corcym UK Limited, London, UK) inside Freestyle prosthesis (Medtronic Inc., Dublin, Ireland) or bioroots from 2018 to 2023. Mean age was 71.1 ± standard deviation 15.1 years and mean EuroSCORE II was 13.5 ± 15.8%, Society of Thoracic Surgeons Score was 5.9 ± 11.7%. Mean transvalvular gradient at baseline was 25.3 ± 19.9 mmHg and left ventricular ejection fraction was 53.5 ± standard deviation 8.5%. In 70.6% (12/17), moderate or severe aortic regurgitation was present. Implant success was 100%. Aortic cross-clamp time was 44.5 ± standard deviation 23.6 min. No patient needed a pacemaker and no mild paravalvular regurgitation occurred. Mean gradient was 12.5 ± 4.7 mmHg; 30-day mortality was 5.9% (1/17). Rate of mortality was lower than predicted by EuroSCORE II in these high-risk patients and haemodynamic outcomes were favourable. Heart teams should consider this treatment concept when discussing patients with failed stentless valves or bioroots.

Third-Generation Transcatheter Aortic Heart Valve with Reverse Parachute Sealing Cuff in Patients with Aortic Valve Disease

The Navitor (Abbott Inc, IL, USA) transcatheter heart valve is a novel third-generation self-expanding bioprosthesis with specific features to mitigate paravalvular regurgitation (PVR). Owing to its novelty, there is a paucity of data on its application in clinical practice. Consecutive cohort analysis of the use of the Navitor system in an as-treated clinical setting at a quaternary heart hospital. Sixty consecutive non-clinical trial patients treated with Navitor were identified. All patients underwent a successful procedure. The mean age was 79.3 years (±SD 7.82), 56.67% (n=34) were female, and the mean STS score was 4.87 (±SD 5.70). At 30 days post-procedure, all patients were alive with no readmissions for heart failure. One patient had a major vascular complication (1.7%). Four patients (7.14% of patients without a pre-existing pacemaker) received a new permanent pacemaker. Two patients (3.4%) had a non-disabling stroke. PVR at 30 days was trivial or none in 75% of patients, and no patient had worse than mild PVR. The Navitor system in this as-treated cohort was associated with favourable clinical, haemodynamic, and safety outcomes.

Mixed aortic valve disease: association with paravalvular leak and reduced survival after transcatheter aortic valve replacement.

Transcatheter aortic valve replacement (TAVR) revolutionized the therapy of severe aortic stenosis (AS) with rising numbers. Mixed aortic valve disease (MAVD) treated by TAVR is gaining more interest, as those patients represent a more complex cohort as compared with isolated AS. However, concerning long-term outcome for this cohort only, limited data are available. The aim of the study is to assess the prevalence of MAVD in TAVR patients, investigate its association with paravalvular regurgitation (PVR), and analyse its impact on long-term mortality after TAVR. We conducted a registry-based cohort study using the Vienna TAVR registry, enrolling patients who underwent TAVR at Medical University of Vienna between January 2007 and May 2020 with available transthoracic echocardiography before and after TAVR (n = 880). Data analysis included PVR incidence and long-term survival outcomes. A total of 647 (73.52%) out of 880 patients had ≥ mild aortic regurgitation next to severe AS. MAVD was associated with PVR compared with isolated AS with an odds ratio of 2.06, 95% confidence interval (CI): 1.51-2.81 (P = <0.001). More than mild PVR after TAVR (n = 168 out of 880: 19.09%) was related to higher mortality compared with the absence of PVR with a hazard ratio (HR) of 1.33, 95% CI: 1.05- 1.67 (P = 0.016). MAVD patients developing ≥ mild PVR after TAVR were also associated with higher mortality compared with the absence of PVR with an HR of 1.30 and 95% CI: 1.04-1.62 (P = 0.022). MAVD is prevalent among TAVR patients and presents unique challenges, with increased PVR risk and worse outcomes compared with isolated AS. Long-term survival for MAVD patients, not limited to those developing PVR post-TAVR, is compromised. Earlier intervention before the occurrence of structural myocardial damage or surgical valve replacement might be a potential workaround to improve outcomes.

Five-Year Follow-Up from the CoreValve Expanded Use Transcatheter Aortic Valve-in-Surgical Aortic Valve Study

Transcatheter aortic valve replacement (TAVR) provides an option for extreme-risk patients who underwent reoperation for a failed surgical aortic bioprosthesis. Long-term data on patients who underwent TAVR within a failed surgical aortic valve (TAV-in-SAV) are limited. The CoreValve Expanded Use Study evaluated patients at extreme surgical risk who underwent TAV-in-SAV. Outcomes at 5 years were analyzed by SAV failure mode (stenosis, regurgitation, or combined). Echocardiographic outcomes are site-reported. TAV-in-SAV was attempted in 226 patients with a mean age of 76.7 ± 10.8 years; 63.3% were male, the Society of Thoracic Surgeons predicted risk of mortality score was 9.0 ± 6.7%, and 87.5% had a New York Heart Association classification III or IV symptoms. Most of the failed surgical bioprostheses were stented (81.9%), with an average implant duration of 10.2 ± 4.3 years. The 5-year all-cause mortality or major stroke rate was 47.2% in all patients; 54.4% in the stenosis, 37.6% in the regurgitation, and 38.0% in the combined groups (p=0.046). At 5 years, all-cause mortality was higher in patients with versus without 30-day severe prosthesis-patient mismatch (51.7% vs 38.3%, p=0.026). The overall aortic valve reintervention rate was 5.9%; highest in the regurgitation group (12.6%). The mean aortic valve gradient was 14.1 ± 9.8 mm Hg and effective orifice area was 1.57 ± 0.70 at 5 years. Few patients had >mild paravalvular regurgitation at 5 years (5.5% moderate, 0.0% severe). TAV-in-SAV with supra-annular, self-expanding TAVR continues to represent a safe and lasting intermediate option for extreme-risk patients who have appropriate sizing of the preexisting failed surgical valve. Clinical and hemodynamic outcomes were stable through 5 years.

Association between three-year mortality after transcatheter aortic valve implantation and paravalvular regurgitation graded by videodensitometry in comparison with visual grading

BackgroundEstimation of regurgitant fraction by videodensitometry (VD-AR) of aortic root angiograms is a new tool for objective grading of paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI). Stratification with boundaries at 6% and 17% has been proposed to reflect “none/trace”, “mild” and “moderate or higher” PVR.ObjectiveWe sought to investigate the association of strata of VD-AR with 3-year mortality and to compare VD-AR with visual grading of angiograms.MethodsWe interrogated our database for patients undergoing transfemoral TAVI from 2008 to 2018. Vital status of the patients was obtained from population registers. To test differences in survival and estimate adjusted hazard ratios (HRs) we fitted Cox models.ResultsOur retrospective study included 699 patients with evaluable angiograms at completion of the TAVI procedure. Cumulative 3-year mortality was 35.0% in 261 (37.3%) patients with VD-AR < 6%, 33.9% in 325 (46.5%) patients with VD-AR between 6 and 17% (HR [95% confidence interval] 1.06 [0.80–1.42]; P = 0.684) and 47.2% in 113 (16.2%) patients with VD-AR > 17% (HR 1.57 [1.11–2.22]; P = 0.011). Visually, PVR was graded as “none/trace” in 470 (67.2%) patients, as “mild” in 219 (31.3%) and as “moderate” in 10 (1.4%). Both mild PVR and moderate PVR on visual grading were significantly associated with mortality (HRs 1.31 [1.12–1.54]; P = 0.001 and 1.92 [1.13–3.24]; P = 0.015; respectively).ConclusionsVD-AR > 17%, but not VD-AR 6–17%, was independently associated with mortality. Compared with subjective visual evaluation, VD-AR resulted in a smaller proportion of patients with PVR classified as prognostically relevant.Graphical

Consistency of transesophageal echocardiography and angiography in grading paravalvular regurgitation during transcatheter aortic valve replacement.

The Valve Academic Research Consortium 3 (VARC-3) standardizes the classification criteria and Doppler parameters for paravalvular regurgitation (PVR) by echocardiography. However, the consistency between transesophageal echocardiography (TEE) and angiography in grading (using the VARC-3 criteria) of PVR during transcatheter aortic valve replacement (TAVR) is unclear. Forty-six patients who underwent TEE and angiography during TAVR were retrospectively included. All patients had complete baseline information, TEE and angiography data. The Doppler parameters measured by TEE included the circumferential extent of PVR, regurgitation volume, regurgitation fraction, and the effective regurgitant orifice area. PVR was classified into four grades: absent, mild, moderate and severe. The weighted kappa coefficient was used to analyze the consistency between the two techniques. Kendall's W coefficient was used to evaluate the consistency of parameters measured by TEE. Among all patients, there were 43 cases (93.5%) with consistent assessments between TEE and angiography. PVR was observed in 19 cases. TEE assessed mild PVR in 17 cases and moderate PVR in two cases; Angiography assessed mild PVR in 14 cases and moderate PVR in two cases. The weighted kappa coefficient between angiography and the circumferential extent of PVR, regurgitation volume, regurgitation fraction, and the effective regurgitant orifice area respectively was .84, .79, .74, .85 (P < .001). Kendall's W coefficient was .83 (P < .001). TEE and angiography had strong consistency in the grading (using the VARC-3 criteria) of PVR during TAVR. TEE was a convenient diagnostic tool to quantify and grade PVR during TAVR.

Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement Compared With Surgical Valve Replacement in Intermediate-Risk Patients

BackgroundPrevious studies demonstrated transcatheter aortic valve replacement (TAVR) with an earlier generation balloon-expandable valve to be noninferior to surgical aortic valve replacement (SAVR) for death and disabling stroke in intermediate-risk patients with symptomatic, severe aortic stenosis at 5 years. However, limited long-term data are available with the more contemporary SAPIEN 3 (S3) bioprosthesis. ObjectivesThe aim of this study was to compare 5-year risk-adjusted outcomes in intermediate-risk patients undergoing S3 TAVR vs SAVR. MethodsPropensity score matching was performed to account for baseline differences in intermediate-risk patients undergoing S3 TAVR in the PARTNER 2 (Placement of Aortic Transcatheter Valves) S3 single-arm study and SAVR in the PARTNER 2A randomized clinical trial. The primary composite endpoint consisted of 5-year all-cause death and disabling stroke. ResultsA total of 783 matched pairs of intermediate-risk patients with severe aortic stenosis were studied. There were no differences in the primary endpoint between S3 TAVR and SAVR at 5 years (40.2% vs 42.7%; HR: 0.87; 95% CI: 0.74-1.03; P = 0.10). The incidence of mild or greater paravalvular regurgitation was more common after S3 TAVR. There were no differences in structural valve deterioration–related stage 2 and 3 hemodynamic valve deterioration or bioprosthetic valve failure. ConclusionsIn this propensity-matched analysis of intermediate-risk patients, 5-year rates of death and disabling stroke were similar between S3 TAVR and SAVR. Rates of structural valve deterioration–related hemodynamic valve deterioration were similar, but paravalvular regurgitation was more common after S3 TAVR. Longer-term follow-up is needed to further evaluate differences in late adverse clinical events and bioprosthetic valve durability. (PII S3i [PARTNER II Trial: Placement of Aortic Transcatheter Valves II – S3 Intermediate], NCT03222128; PII A (PARTNER II Trial: Placement of Aortic Transcatheter Valves II – XT Intermediate and High Risk], NCT01314313)

Immediate right chambers remodelling after orthotopic transcatheter valve tricuspid replacement.

An 84-year-old man with atrial fibrillation, ischemic heart disease with surgical and percutaneous revascularization, complained about effort abdominal pain and dyspnoea (NYHA III), with asthenia and peripheral oedema. Transoesophageal echocardiography showed torrential atrial tricuspid regurgitation and dilated right ventricle with preserved ejection fraction (Panels A–C). Invasive systolic pulmonary pressure was 30 mmHg. The TRI-SCORE was 30%. Considering the symptoms and signs of right heart failure despite optimal medical treatment and the prohibitive surgical risk, the patient was selected for tricuspid transcatheter valve replacement with Cardiovalve (VenusMedtech, Hangzhou, China) according to Heart Team evaluation. Repair percutaneous techniques were rejected, transcatheter annuloplasty due to right coronary artery proximity and thin tissue, and edge-to-edge approach because of the gap of 1 cm. The 32-F Large Cardiovalve system was inserted via surgically exposed femoral vein and was advanced into the right atrium. Under transesophageal echocardiographic and fluoroscopic guidance, the device legs were opened in the atrium and advanced into ventricle and grasp the 3 native leaflets by pulling the system (Panel D). Finally, the atrial followed the ventricular flanges that were released (Panel E). There was a posterior mild paravalvular regurgitation (Panels F and G, Supplementary data online, Videos S1 and S2). After 1 month, the patient is NYHA class I, neither having effort abdominal pain nor peripheral oedema. CT scan showed a significant reduction of the right ventricular diastolic volume from 256 to 216 mL, and the right atrium from 89 to 71 mL, even persisting atrial fibrillation (Panel H, Supplementary data online, Video S3).

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.

3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis

BackgroundRandomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) with surgery in low–surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process. ObjectivesThe authors evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial. MethodsLow-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years. ResultsThere were 1,414 attempted implantations (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR: 0.70; 95% CI: 0.49-1.00; P = 0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: −1.8% at year 1; −2.0% at year 2; and −2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P < 0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were <1% and not significantly different. Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs 12.1 mm Hg surgery; P < 0.001) at 3 years. ConclusionsWithin the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared with surgery with respect to all-cause mortality or disabling stroke. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283)

Impact of Mild Paravalvular Regurgitation on Long-Term Clinical Outcomes After Transcatheter Aortic Valve Implantation

The impact of mild paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI) remains controversial. We evaluated the impact of mild PVR after TAVI on long-term clinical outcomes. We included patients who underwent TAVI for severe symptomatic aortic stenosis between December 2008 and June 2019 at 2 international centers and compared all-cause death between the group with mild PVR (group 1) and the group with none or trace PVR (group 2). PVR was categorized using a 3-class grading scheme, and patients with PVR ≧ moderate and those who were lost to follow-up were excluded. This retrospective analysis included 1,404 patients (mean age 81.7 ± 6.5 years, 58.0% women). Three hundred fifty eight patients (25.5%) were classified into group 1 and 1,046 patients (74.5%) into group 2. At baseline, group 1 was older and had a lower body mass index, worse co-morbidities, and more severe aortic stenosis. To account for these differences, propensity score matching was performed, resulting in 332 matched pairs. Within these matched groups, during a mean follow-up of 3.2 years, group 1 had a significantly lower survival rate at 5 years (group 1: 62.0% vs group 2: 68.0%, log-rank p=0.029, hazard ratio: 1.41 [95% confidence interval: 1.04 to 1.91]). In the matched cohort, patients with mild PVR had a significant 1.4-fold increased risk of mortality at 5 years after TAVI compared with those with none or trace PVR. Further studies with more patients are needed to evaluate the impact of longer-term outcomes.

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.

Left ventricular reverse remodeling in post operative aortic stenosis patients: prevalence and predictor(s)

Abstract Background In patients with severe aortic stenosis (AS), left ventricular (LV) remodeling is believed to be a compensatory adaptive process which should reverse after aortic valve intervention. However, this is not always the rule and remodeling persistence may negatively impact post-procedural outcomes and survival. Aim To assess the prevalence and predictors of morphological LV reverse remodeling in severe symptomatic AS patients after surgical aortic valve replacement (AVR). Methods We prospectively studied 75 patients (72y [68–77y], 45% male) with severe symptomatic AS - mean gradient (AVM): 61±17mmHg; mean indexed aortic valve area (AVAi) 0.41±0.10 cm2/m2 with no previous history of ischemic cardiomyopathy, all with high gradient, 4 with low-flow, 81% with hypertension, 27% with type 2 diabetes mellitus and 35% patients with stage 3 chronic kidney disease: median MDR creat clearance: 70.4mL/min [40–102]. All patients performed pre-operative cardiac magnetic resonance (CMR) at a mean period of 3.4 months (0–17 months) before AVR and at the 3–6th months after AVR, for LV reverse remodeling assessment. It was defined as at least the occurrence of one of the following: &amp;gt;15% reduction in LVEDVi; &amp;gt;15% reduction in LVMi by CMR; &amp;gt;10% reduction in geometric remodeling ratio. Clinical, AV severity data, preoperative functional LV and tissue characterization data were analyzed at multivariate regression to predict the occurrence of LV reverse remodeling. Results Overall, at pre-operative CMR: mean LV indexed mass (LVMi): 82±28.9 g/m2; mean end-diastolic LV indexed volume (LVEDVi): 87.4±26.6 mL/m2; mean geometric remodeling (LV mass/end-diastolic volume): 0.92±0.2 g/mL. After AVR, at echocardiographic evaluation, no patient had prosthetic obstruction or prosthetic patient mismatch: median LV-Ao gradient 12mmHg [9.1–14 mmHg]; 5 of them had mild paravalvular regurgitation. LV reverse remodeling occurred in 65 patients (88%) (Figure 1A) and these were younger, had significantly smaller preoperative AVAi and higher valvular gradients (Figure 1B). At multivariate analysis, only preoperative AVAi remained an independent predictor (odds ratio 0.85, 95% CI 0.735–0.984, p=0.029). Conclusions In this prospective cohort of patients LV reverse remodeling after surgical AVR was highly frequent, occurring in almost nine out of every ten patients. Funding Acknowledgement Type of funding sources: None.

Five-year outcomes of mild paravalvular regurgitation after transcatheter aortic valve implantation.

Mild paravalvular regurgitation (PVR) remains a frequent and underappreciated adverse event after transcatheter aortic valve implantation (TAVI) despite remarkable progress in device technology and implantation technique. This study sought to investigate the impact of mild PVR after TAVI on five-year clinical outcomes. In a prospective TAVI registry, PVR prior to discharge was retrospectively assessed in an echocardiographic core laboratory. Patients with ≥moderate PVR were excluded. Mild PVR was categorised into mild and mild-to-moderate PVR using a recently proposed unifying 5-class grading scheme. A total of 1,128 patients undergoing TAVI between 2007 and 2015 were enrolled. Of these, 560 patients had mild PVR, including 433 with mild (5-class) PVR and 127 with mild-to-moderate PVR. Patients with mild PVR were older (83 years vs 82 years, p=0.013) and had a higher surgical risk compared to patients with none/trace PVR (STS-PROM: 6.49±4.68 vs 5.41±3.48, p<0.001). At five years, patients with mild PVR had a higher risk of mortality than those with none/trace PVR (54.6% vs 43.8%; HRadjusted 1.26, 95% CI: 1.06-1.50). When applying the 5-class grading scheme, only mild-to-moderate PVR was associated with an increased risk of mortality at five years (mild PVR: HRadjusted 1.19, 95% CI: 0.99-1.43, mild-to-moderate PVR: HRadjusted 1.56, 95% CI: 1.20-2.02). The effect of mild PVR on five-year mortality was consistent across major subgroups. Mild PVR was associated with an increased risk of mortality at five years after TAVI. The detrimental effect was primarily driven by mild-to-moderate PVR using the 5-class grading scheme. https://www. gov. NCT01368250.

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.

Novel pressure-regulated deployment strategy for improving the safety and efficacy of balloon-expandable transcatheter aortic valves

Abstract Background The optimal method for balloon-expandable transcatheter heart valve (THV) deployment remains unknown. Current implantation protocols are volume-dependent and rely on ad-hoc filling of the deployment apparatus without accounting for annular wall tension during prosthesis expansion, predisposing patients to inconsistent clinical outcomes. During THV deployment, the annular wall tension exerted by the expanding prosthesis is determined by prosthesis diameter and balloon pressure (Laplace's Law). Objective We proposed and tested a novel method for balloon-expandable THV deployment, aimed at controlling balloon pressure and the resulting annular wall tension to allow optimal prosthesis-annulus apposition while preventing significant tissue injury. Methods 330 consecutive patients with severe native aortic stenosis who underwent balloon-expandable THV implantation between 2015–2020 were included. 106 patients were considered high-risk for annular rupture. THVs were deployed until reaching a pre-determined balloon pressure; 4–4.5atm in earlier cases to establish experience and safety, later increasing to 5–6.5atm in most cases. Post-dilatation was performed to reduce &amp;gt;mild angiographic regurgitation (PVR). Using a biomechanical model, annular wall stress (tension) was estimated for each case and assessed against recorded rates of post-dilatation, ≥mild paravalvular regurgitation (PVR) on TTE, new PPM or LBBB and annular rupture. Results Patients with wall stress &amp;gt;3MPa (n=184) had reduced post-dilatation rate (p&amp;lt;0.001) and final PVR (≥mild, p=0.014). Annular rupture occurred in 2/3 high-risk cases with wall stress &amp;gt;3.5MPa; no rupture occurred in 102 high-risk cases with wall stress ≤3.5MPa. Based on these results, we defined target deployment wall stress levels (3–3.5MPa) and associated deployment pressure per THV size. Patients within this target range (n=136) had 8.1% new PPM, 12.5% new LBBB, 12.7% mild PVR with no cases of ≥moderate PVR. Importantly, there was an inconsistent relationship between deployment balloon volume and resulting annular wall stress. Conclusion Pressure-regulated THV deployment is a simple, easily reproducible, safe and effective method, regardless of high-risk anatomical complexities. Funding Acknowledgement Type of funding sources: None. Annular wall stress and PVRModel, stress vs volume and new strategy

Outcomes of sutureless aortic valve replacement versus conventional aortic valve replacement and transcatheter aortic valve replacement, updated systematic review, and meta-analysis.

Sutureless aortic valve replacement (SuAVR) is an alternative to surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). This study compares the effectiveness of SuAVR to SAVR and TAVR. We searched MEDLINE and EMBASE from inception to July 2021 for studies evaluating SuAVR, SAVR, and TAVR in adults with aortic stenosis. We performed screening, full-text assessment, data collection, and risk of bias evaluation independently and in duplicate. We evaluated risk of bias using by Cochrane and CLARITY's tools, and certainty in evidence using the GRADE framework. Data were pooled using a random-effects model. We identified one randomized and 78 observational studies (n = 60,689; SuAVR vs. SAVR = 39,171, vs. TAVR = 21,518). All studies were at high or unclear risk of bias, with very-low certainty in effect estimates. Compared to TAVR, SuAVR demonstrates no significant difference in mortality at 30-days (odds ratio [OR]: 0.52, 95% confidence interval [CI: 0.85, 1.16], I2 = 0%), but decreased odds at 2-years (OR: 0.39, 95% CI [0.17, 0.88], I2 = 0%). SuAVR also reduced odds of mild paravalvular regurgitation (OR: 0.11, 95% CI [0.06, 0.21], I2 = 50%). Compared to SAVR, SuAVR was associated with a similar mortality at 30-days (OR: 0.99, 95% CI [0.85, 1.16], I2 = 0%) and 2-years (OR:0.99, 95% CI [0.43-2.30], I2 = 7%). SuAVR significantly increased odds of permanent pacemaker implantation (OR: 2.5, 95% CI [2.25, 2.77], I2 = 0%). Pooled effect estimates were consistent with results from the randomized trial comparing SuAVR and SAVR. Based on very-low quality evidence, SuAVR is associated with similar short- and midterm outcomes compared to TAVR and SAVR. Comparative randomized data with long-term follow-up are required to clarify the role of SuAVR.

Impact of Annular Oversizing on Paravalvular Regurgitation and ValveHemodynamics: New Insights From PARTNER 3.

This study sought to investigate the impact of computed tomography (CT)-based area and perimeter oversizing on the incidence of paravalvular regurgitation (PVR) and valve hemodynamics in patients treated with the SAPIEN 3 transcatheter heart valve (THV). The incremental value of considering annular perimeter or left ventricular outflow tract measurements and the impact of THV oversizing on valve hemodynamics are not well defined. The PARTNER 3 (Placement of Aortic Transcatheter Valves 3) trial included 495 low-surgical-risk patients with severe aortic stenosis who underwent THV implantation. THV sizing was based on annular area assessed by CT. Area- and perimeter-based oversizing was determined using systolic annular CT dimensions and nominal dimensions of the implanted THV. PVR, effective orifice area, and mean gradient were assessed on 30-day transthoracic echocardiography. Of 485 patients with available CT and echocardiography data, mean oversizing was 7.9 ± 8.7% for the annulus area and 2.1 ± 4.1% for the perimeter. A very low incidence of≥moderate PVR (0.6%) was observed, including patients with minimal annular oversizing. Incidence of≥mild PVR and need for procedural post-dilatation were inversely related to the degree of oversizing. For patients with annular dimensions suitable for 2 THV sizes, the larger THV with both area and perimeter oversizing was associated with the lowest incidence of≥mild PVR (12.0% vs 43.4%; P<0.0001). Left ventricular outflow tract area oversizing was not associated with PVR. THV prosthesis size, rather than degree of oversizing, had greatest impact on effective orifice area and mean gradient. In low-surgical-risk patients, a low incidence of≥moderate PVR was observed, including patients with minimal THV oversizing. The degree of prosthesis oversizing had the greatest impact on reducing mild PVR and incidence of post-dilatation, without impacting valve hemodynamics. In selected patients with annular dimensions in between 2 valve sizes, the larger THV device oversized to both the annular area and perimeter reduced PVR and optimized THV hemodynamics.