Valve-in-valve Transcatheter Aortic Valve Implantation Research Articles

A multimodal approach to predict prosthesis-patient mismatch in patients undergoing valve-in-valve trans-catheter aortic valve implantation

AimsThe valve-in-valve transcatheter-aortic-valve-implantation (VIV-TAVI) represents an emerging procedure for the treatment of degenerated aortic bio-prostheses, and the occurrence of patient-prosthesis mismatch (PPM) after VIV-TAVI might affect its clinical efficacy. This study aimed to test a multimodal imaging approach to predict PPM risk during the TAVI planning phase and assess its clinical predictivity in VIV-TAVI procedures. MethodsConsecutive patients undergoing VIV-TAVI procedures at our Institution over 6 years were screened and those treated by self-expandable supra-annular valves were selected. The effective orifice area (EOA) was calculated with a hybrid Gorlin equation combining echocardiographic data with invasive hemodynamic assessment. Severe PPM was defined according to such original multimodality assessment as EOAi≤0.65 cm2/m2 (if BMI < 30 kg/m2) or < 0.55 cm2/m2 (if BMI ≥ 30 kg/m2). The primary endpoint was a composite of all-cause mortality and valve-related re-hospitalization during the clinical follow-up. ResultsA total of 40 VIV-TAVI was included in the analysis. According to the pre-specified multimodal imaging modality assessment, 18 patients (45.0 %) had severe PPM. Among all baseline clinical and anatomical characteristics, estimated glomerular filtration rate before VIV-TAVI (OR 0.872, 95%CI[0.765–0.994],p = 0.040), the echocardiographic pre-procedural ≥moderate AR (OR 0.023, 95%CI[0.001–0.964],p = 0.048), the MSCT-derived effective internal area (OR 0.958, 95%CI[0.919–0.999],p = 0.046) and the implantation depth (OR 2.050, 95%CI[1.028–4.086],p = 0.041) resulted as independent predictors of severe PPM at multivariable logistic analysis. At a mean follow-up of 630 days, patients with severe PPM showed a higher incidence of the primary endpoint (9.1%vs.44.4 %;p = 0.023). ConclusionIn VIV-TAVI using self-expandable supra-annular valves, a multimodal imaging approach might improve clinical outcome predicting severe PPM occurrence.

An unusual complication after transcatheter aortic valve implantation: a case report

Abstract Background Ventricular septal defect (VSD) is an unusual complication of transcatheter aortic valve implantation (TAVI). The risk factors are not well understood but may include oversizing, calcification amount and location, left-ventricular chamber morphology, and valve-in-valve (ViV) procedures. Percutaneous treatment is challenging but is usually the preferred option. Case summary An 80-year-old woman with two previous surgical aortic valve replacements was admitted to our Cardiology Department for decompensated heart failure. New bioprosthesis degeneration (19 mm Mitroflow™, Sorin Group, Canada) was observed with severe intraprosthetic aortic regurgitation. After evaluation, the heart team chose to perform ViV TAVI. Because of the high risk of coronary obstruction, chimney stenting of both coronary arteries was performed. A 23 mm self-expandable Navitor™ valve (Abbott, IL, USA) was implanted, but the Mitroflow™ valve had to be cracked to minimize the persistent high gradient. During valve fracture, the non-compliant balloon broke and a small iatrogenic VSD appeared. However, the patient remained stable, so conservative management was selected. During follow-up, she developed severe haemolytic anaemia and heart failure; therefore, percutaneous closure of the iatrogenic VSD was performed twice, which was a difficult challenge. Discussion A viable alternative to redo surgery is ViV TAVI. Risks include higher rates of prosthesis–patient mismatch and coronary obstruction. Occasionally, bioprosthetic valve fracture is required, particularly in small bioprostheses, to achieve low gradients. Anecdotally, fracture has led to annular rupture and VSD. Most VSDs are small and without clinical or haemodynamic repercussions; however, in symptomatic cases, percutaneous closure is a viable alternative to surgery.

Long-Term Outcomes of Valve-in-Valve Transcatheter Aortic Valve Implantation Versus Redo Surgical Aortic Valve Replacement: Meta-Analysis of Kaplan–Meier–Derived Data

Valve-in-valve (ViV) transcatheter aortic valve implantation (ViV-TAVI) in patients with failed bioprostheses arose as an alternative to redo surgical aortic valve replacement (SAVR). To evaluate all-cause mortality in ViV-TAVI versus redo-SAVR, we performed a study-level meta-analysis of reconstructed time-to-event data from Kaplan-Meier curves of nonrandomized studies published by August 2023. A total of 16 studies met our eligibility criteria, with a total of 4,373 patients (2,204 patients underwent ViV-TAVI and 2,169 patients underwent redo-SAVR). Pooling all the studies, ViV-TAVI showed a lower risk of all-cause mortality in the first 6months (hazard ratio [HR] 0.58, 95% confidence interval [CI] 0.46 to 0.73, p <0.001), with an HR reversal after this time point favoring redo-SAVR (HR 1.92, 95% CI 1.58 to 2.33, p <0.001). Pooling only the matched populations (which represented 64.6% of the overall population), ViV-TAVI showed a lower risk of all-cause mortality in the first 6 months (HR 0.56, 95% CI 0.43 to 0.73, p <0.001], with a reversal after 6 months favoring redo-SAVR (HR 1.55, 95% CI 1.25 to 1.93, p <0.001). The meta-regression analyses revealed a modulating effect of the following covariates: age, coronary artery disease, history of coronary artery bypass graft surgery, and implanted valves <25mm. In conclusion, ViV-TAVI is associated with better survival immediately after the procedure than redo-SAVR; however, this primary advantage reverses over time, and redo-SAVR seems to offer better survival at a later stage. Because these results are pooled data from observational studies, they should be interpreted with caution, and randomized controlled trials are warranted.

Prognostic Impact of Residual Moderate Mitral Regurgitation Following Valve-in-Valve Transcatheter Aortic Valve Implantation.

The impact of mitral regurgitation (MR) on valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) in patients with failed bioprostheses remains unclear. The purpose of this study was to assess the prognostic impact of residual moderate MR following VIV-TAVI. We retrospectively analyzed 127 patients who underwent VIV-TAVI between March 2010 and November 2021. At least moderate MR was observed in 51.2% of patients before the procedure, and MR improved in 42.1% of all patients. Patients with postoperative severe MR, previous mitral valve intervention, and patients who died before postoperative echocardiography were excluded from further analyses. The remaining 114 subjects were divided into two groups according to the degree of postprocedural MR: none-mild MR (73.7%) or moderate MR (26.3%). Propensity score matching yielded 23 pairs for final comparison. No significant differences were found between groups before and after matching in early results. In the matched cohort, survival probabilities at one, three, and five years were 95.7% vs. 87.0%, 85.0% vs. 64.5%, and 85.0% vs. 29.0% in the none-mild MR group vs. moderate MR-group, respectively (log-rank P=0.035). Among survivors, patients with moderate MR had worse functional status according to New York Heart Association (NYHA) class at follow-up (P=0.006). MR is common in patients with failed aortic bioprostheses, and improvement in MR-status was observed in over 40% of patients following VIV-TAVI. Residual moderate MR after VIV-TAVI is not associated with worse early outcomes, however, it was associated with increased mortality at five years of follow-up and worse NYHA class among survivors.

Short- and Medium-Term Outcomes Comparison of Native- and Valve-in-Valve TAVI Procedures.

In high-risk patients with degenerated aortic bioprostheses, valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) has emerged as a less invasive alternative to surgical valve replacement. To compare outcomes of ViV and native valve (NV) TAVI procedures. 34 aortic ViV-TAVI performed between 2012 and 2022 using self-expanding valves, were included in this retrospective analysis. Propensity score matching (1:2 ratio, 19 criteria) was used to select a comparison NV-TAVI group from a database of 1206 TAVI procedures. Clinical and echocardiographic endpoints, short- and long-term all-cause mortality (ACM) and cardiovascular mortality (CVM) data were obtained. Subgroup analyses were completed according to the true internal diameter, dividing patients into a small ( 19 mm) valve group (SVG) and a large ( 19 mm) valve group (LVG). Clinical outcomes of ViV- and NV-TAVI were comparable, including device success [88.2% vs. 91.1%, p = 0.727], major adverse cardiovascular and cerebrovascular events [5.8% vs. 5.8%, p = 1.000], hemodialysis need [5.8% vs. 2.9%, p = 0.599], pacemaker need [2.9% vs. 11.7%, p = 0.265], major vascular complications [2.9% vs. 1.4%, p = 1.000], life-threatening or major bleeding [2.9% vs. 1.4%, p = 1.000] and in-hospital mortality [8.8% vs. 5.9%, p = 0.556]. There was a significant difference in the immediate post-intervention mean residual aortic valve gradient (MAVG) [14.6 8.5 mm Hg vs. 6.4 4.5 mm Hg, p 0.0001], which persisted at 1 year [p = 0.0002]. There were no differences in 12- or 30-month ACM [11.8% vs. 8.8%, p = 0.588; 23.5% vs. 27.9%, p = 0.948], and CVM [11.8% vs. 7.3%, p = 0.441; 23.5% vs. 16.2%, p = 0.239]. Lastly, there was no difference in CVM at 1 year and 30 months [11.1% vs. 12.5%, p = 0.889; 22.2% vs. 25.0%, p = 0.742]. Analyzing a limited group (n = 34) of ViV-TAVI procedures out of 1206 TAVIs done at a single institution, ViV-TAVI appeared to be an acceptable approach in patients not deemed appropriate candidates for redo valve replacement surgery. Clinical outcomes of ViV-TAVI were comparable to TAVI for native valve stenosis.

Valve-in-valve TAVI and risk of coronary obstruction: Validation of the VIVID classification

BackgroundThe Valve-in-Valve International Data (VIVID) registry proposed a simplified classification to assess the risk of coronary obstruction during valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) based on preprocedural multi-detector computed tomography (MDCT). We investigated the validity of the VIVID classification in patients undergoing ViV-TAVI for degenerated bioprostheses. MethodsPatients undergoing ViV-TAVI for degenerated bioprostheses were prospectively included in this study. The risk of coronary obstruction among patients treated with stented valves was retrospectively evaluated based on anatomical assessment on pre-procedural MDCT. ResultsAmong a total of 137 patients that underwent ViV-TAVI between August 2007 and June 2021, 109 patients had stented, sutureless, or transcatheter degenerated bioprosthesis of which 96 (88%) had adequate MDCT data for risk assessment. High-risk anatomy for coronary obstruction (VIVID type IIB, IIIB, or IIIC) in either the left or right coronary artery was observed in 30 patients (31.3%). Of the 30 patients with high-risk anatomy, coronary protection using wire protection or BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) was performed in 3 patients (10.0%). Three patients treated with stentless valves and one patient treated with a stented valve with externally mounted leaflets had coronary obstruction. None of the patients with high risk anatomy according to MDCT had coronary obstruction even without coronary protection. ConclusionsCoronary obstruction occurred in none of the patients classified as high-risk patients according to the VIVID classification despite the absence of coronary protection. Refined tools are required to assess the risk of coronary obstruction. Clinical trial registrationhttps://www.clinicaltrials.gov. NCT01368250.

Redo Surgical Aortic Valve Replacement versus Valve-In-Valve Transcatheter Aortic Valve Implantation: A Systematic Review and Reconstructed Time-To-Event Meta-Analysis.

Valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) has emerged as a useful alternative intervention to redo-surgical aortic valve replacement (Redo-SVAR) for the treatment of degenerated bioprosthesis valve. However, there is no robust evidence about the long-term outcome of both treatments. The aim of this meta-analysis was to analyze the long-term outcomes of Redo-SVAR versus ViV-TAVI by reconstructing the time-to-event data. The search strategy consisted of a comprehensive review of relevant studies published between 1 January 2000 and 30 September 2022 in three electronic databases, PubMed, Cochrane Central Register of Controlled Trials (CENTRAL) and EMBASE. Relevant studies were retrieved for the analysis. The primary endpoint was the long-term mortality for all death. The comparisons were made by the Cox regression model and by landmark analysis and a fully parametric model. A random-effect method was applied to perform the meta-analysis. Twelve studies fulfilled the eligibility criteria and were included in the final analysis. A total of 3547 patients were included. Redo-SAVR group included 1783 patients, and ViV-TAVI included 1764 subjects. Redo-SAVR showed a higher incidence of all-cause mortality within 30-days [Hazard ratio (HR) 2.12; 95% CI = 1.49-3.03; p &lt; 0.0001)], whereas no difference was observed between 30 days and 1 year (HR = 1.03; 95% CI = 0.78-1.33; p = 0.92). From one year, Redo-SAVR showed a longer benefit (HR = 0.52; 95% CI = 0.40-0.67; p &lt; 0.0001). These results were confirmed for cardiovascular death (HR = 2.04; 95% CI = 1.29-3.22; p = 0.001 within one month from intervention; HR = 0.35; 95% CI = 0.18-0.71; p = 0.003 at 4-years follow-up). Although the long-term outcomes seem similar between Redo-SAVR and ViV-TAVI at a five-year follow-up, ViV-TAVI shows significative lower mortality within 30 days. This advantage disappeared between 30 days and 1 year and reversed in favor of redo-SAVR 1 year after the intervention.

Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA) in valve-in-valve Transcatheter Aortic Valve Implantation (ViV-TAVI): First experience in Poland.

Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA) in valve-in-valve Transcatheter Aortic Valve Implantation (ViV-TAVI): First experience in Poland.

Valve-in-valve transcatheter aortic valve replacement or re-surgical aortic valve replacement in degenerated bioprostheses: A systematic review and meta-analysis of short and midterm results.

Despite limited to short and midterm outcomes, valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) has emerged as a valid alternative to re-surgical aortic valve replacement (re-SAVR) for high- and intermediate-risk patients with degenerated surgical bioprosthesis. All studies comparing multivariate adjustment between ViV TAVI and re-SAVR were screened. The primary end-points were all-cause and cardiovascular (CV) mortality at 30 days and at Midterm follow-up. Short-term complications were the secondary endpoints. We obtained data from 11 studies, encompassing 8570 patients, 4224 undergoing ViV TAVI, and 4346 re-SAVR. Four studies included intermediate-risk patients and seven high-risk patients. 30-day all-cause and CV mortality were significantly lower in ViV (odds ratio [OR] 0.43, 95% confidence intervals [CIs] 0.29-0.64 and OR 0.44, 0.26-0.73 respectively), while after a mean follow-up of 717 (180-1825) days, there was no difference between the two groups (OR 1.04, 0.87-1.25 and OR 1.05, 0.78-1.43, respectively). The risk of stroke (OR 1.03, 0.59-1.82), MI (OR 0.70, 0.34-1.44), major vascular complications (OR 0.92, 0.50-1.67), and permanent pacemaker implantation (OR 0.67, 0.36-1.25) at 30 days did not differ, while major bleedings and new-onset atrial fibrillation were significantly lower in ViV patients (OR 0.41, 0.25-0.67 and OR 0.23, 0.12-0.42, respectively, all 95% CIs). In high- and intermediate-risk patients with degenerated surgical bioprostheses, ViV TAVI is associated with reduced short-term mortality, compared with re-SAVR. Nevertheless, no differences were found in all-cause and CV mortality at midterm follow-up. PROSPERO CRD42021226488.

Outcomes in Valve-in-Valve Transcatheter Aortic Valve Implantation

The use of valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) is increasing, but studies evaluating clinical outcomes in these patients are scarce. Also, there are limited data to guide the choice of valve type in ViV-TAVI. Therefore, this CENTER-study evaluated clinical outcomes in patients with ViV-TAVI compared to patients with native valve TAVI (NV-TAVI). In addition, we compared outcomes in patients with ViV-TAVI treated with self-expandable versus balloon-expandable valves. A total of 256 patients with ViV-TAVI and 11333 patients with NV-TAVI were matched 1:2 using propensity score matching, resulting in 256 patients with ViV-TAVI and 512 patients with NV-TAVI. Mean age was 81±7 years, 58% were female, and the Society of Thoracic Surgeons Predicted Risk of Mortality was 6.3% (4.0% to 12.8%). Mortality rates were comparable between ViV-TAVI and NV-TAVI patients at 30 days (4.1% vs 5.9%, p=0.30) and 1 year (14.2% vs 17.3%, p=0.34). Stroke rates were also similar at 30 days (2.8% vs 1.8%, p=0.38) and 1 year (4.9% vs 4.3%, p=0.74). Permanent pacemakers were less frequently implanted in patients with ViV-TAVI (8.8% vs 15.0%, relative risk 0.59, 95% confidence interval [CI] 0.37 to 0.92, p=0.02). Patients with ViV-TAVI were treated with self-expandable valves (n=162) and balloon-expandable valves (n=94). Thirty-day major bleeding was less frequent in patients with self-expandable valves (3% vs 13%, odds ratio 5.12, 95% CI 1.42 to 18.52, p=0.01). Thirty-day mortality was numerically lower in patients with self-expandable valves (3% vs 7%, odds ratio 3.35, 95% CI 0.77 to 14.51, p=0.11). In conclusion, ViV-TAVI seems a safe and effective treatment for failing bioprosthetic valves with low mortality and stroke rates comparable to NV-TAVI for both valve types.

Valve-in-valve transcatheter aortic valve implantation versus repeat surgical aortic valve replacement in patients with a failed aortic bioprosthesis.

Limited data are available regarding clinical outcomes of valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) following the United States Food and Drug Administration approval of ViV TAVI in 2015. The aim of this study was to evaluate in-hospital, 30-day, and 6-month outcomes of ViV TAVI versus repeat surgical aortic valve replacement (SAVR) in patients with a failed aortic bioprosthetic valve. This retrospective cohort study identified patients who underwent ViV TAVI or repeat SAVR utilising the Nationwide Readmission Database from 2016 to 2018. Primary outcomes were all-cause readmission (at 30 days and 6 months) and in-hospital death. Secondary outcomes were in-hospital stroke, pacemaker implantation, 30-day/6-month major adverse cardiac events (MACE), and mortality during readmission. Propensity score-matching (inverse probability of treatment weighting) analyses were implemented. Out of 6,769 procedures performed, 3,724 (55%) patients underwent ViV TAVI, and 3,045 (45%) underwent repeat SAVR. ViV TAVI was associated with lower in-hospital all-cause mortality (odds ratio [OR] 0.42, 95% confidence interval [CI]: 0.20-0.90, p=0.026) and a higher rate of 30-day (hazard ratio [HR] 1.46, 95% CI: 1.13-1.90, p=0.004) and 6-month all-cause readmission (HR 1.54, 95% CI: 1.14-2.10, p=0.006) compared with repeat SAVR. All secondary outcomes were comparable between the two groups. ViV TAVI was associated with lower in-hospital mortality but higher 30-day and 6-month all-cause readmission. However, there was no difference in risk of in-hospital stroke, post-procedure pacemaker implantation, MACE, and mortality during 30-day and 6-month readmission compared with repeat SAVR, suggesting that ViV TAVI can be performed safely in carefully selected patients.

Magnetic retrieval of prosthetic heart valves for redo-TAVI

Bioprosthetic aortic heart valves are known to degenerate within 7–15 years of implantation. Currently, the options for treating a failing valve are (a) redo surgical aortic valve replacement or, increasingly, (b) valve-in-valve transcatheter aortic valve implantation (ViV-TAVI). The ViV-TAVI procedure is referred to as redo-TAVI when the failing valve is a TAVI device. Repeated procedures, such as two or three valve-in-valves, significantly reduce the effective valve flow area, putting a limit on recurrent treatments. With increasing life expectancy and the use of TAVI in younger, lower-risk patients, the demand for multiple replacement procedures will inevitably increase. Against this background, we describe a novel valve system named exchangeable-TAVI (e-TAVI) in which an electromagnetic catheter is used to remove and retrieve a failed exchangeable valve, followed by the immediate deployment of a new valve. The e-TAVI system comprises (i) an exchangeable valve, (ii) a permanent holding member that anchors the exchangeable valve and (iii) a dedicated catheter with electromagnets for removal of the exchangeable valve. Simulations have been performed to determine the forces, frame design and electromagnetic parameters required to crimp and retrieve a 26 mm diameter valve. An optimum configuration was found to comprise a 12 cell self-expanding frame with circular ferromagnetic regions of 1 mm radius and 0.5 mm thickness, along with eight electromagnets of 1 mm radius and 2 mm thickness. A force of 2.87 N and a current of 2.52 A per electromagnet were required to partially crimp the frame to an envelope radius of 11 mm. While this amount of force allowed the frame to be crimped solely through magnetic attraction, re-sheathing of the frame was not possible due to the weaker shear holding force of the magnets. Also, the current was close to the fusing current of the copper wire needed to fit sufficient windings into the available volume. These issues led to the conclusion that, in addition to the magnetic coupling, a mechanical mating between the removal catheter and the exchangeable valve is needed. This would decrease both the force that the electromagnets had to exert during crimping and the current required to generate this force.

Abstract 8962: Meta-Meta-Analysis of Outcomes of Valve-in-Valve TAVI Compared to Redo-SAVR

Introduction: Redo-Surgical valve replacement (Redo-SAVR) is the gold standard treatment for failed degenerated bioprosthetic valves. Recently approved less invasive Valve-In-Valve Transcatheter Aortic Valve Implantation (ViV-TAVI) procedure is becoming more popular but with limited evidence of its safety and efficacy compared to redo-SAVR. Hypothesis: We aimed to conduct the meta-meta analysis to evaluate the outcomes of ViV-TAVI compared to redo-SAVR. Methods: We conducted a systematic search of meta-analysis studies assessing outcomes of ViV-TAVR vs redo-SAVR using PubMed search engine and following PRISMA guidelines from inception to May 2021. A meta-meta-analysis was performed by obtaining a pooled odds ratio, 95% confidence interval (95%CI) using random-effects models to analyze outcomes of 30-day all-cause mortality and procedural mortality. Results: Nine meta-analysis studies were included. We found that there was a significantly lower odds of 30-day all-cause mortality (pooled OR:0.60; 95%CI:0.53-0.68; p&lt;0.00001) with 0% heterogeneity (I2= 0%;p=0.53) in the ViV-TAVI compared to redo-SAVR. We also found a reduced risk of procedural mortality with ViV-TAVI compared to redo-SAVR (pooled OR:0.52; 95%CI:0.27-0.98; p=0.04) with 0% heterogeneity (I2= 0%;p=0.69) (Figure). Conclusions: ViV-TAVI is significantly associated with reduced risk of 30-day all-cause mortality, and procedural mortality compared to redo-SAVR. Our meta-meta-analysis supports that minimally invasive ViV-TAVI is a safe and better procedure for degenerated bioprosthetic valves in high-risk candidates.

Valve-in-valve transcatheter aortic valve replacement or re-surgical aortic valve replacement in degenerated bioprostheses: a systematic review and meta-analysis of short and mid-term results

Abstract Introduction Despite limited to short and mid-term outcomes, Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) has emerged as a less invasive alternative to redo surgery for high and intermediate-risk patients with good outcomes across different surgical risk profiles. Purpose The aim of the resent meta-analysis is to compare short and mid-term outcomes of VIV and surgical redo fo patients with a degenerative aortic bioprosthesis. Methods All studies comparing with multivariate adjustment between ViV TAVI and re-SAVR were screened. All-cause mortality at 30-day and at follow-up were the primary endpoints, while Valve Academy research Consortium (VARC) endpoints at 30 days including stroke, myocardial infarction (MI), major vascular complications, major bleeding, new onset atrial fibrillation (AF) and permanent pacemaker implantation (PPI) during the index hospitalization were the secondary endpoints. Subgroup analysis were performed according to the surgical risk. All the analyses were stratified according to the design of the study (observational vs propensity-matched study). Results We obtained data from 11 studies, encompassing 8570 patients, 4224 undergoing ViV TAVI and 4346 re-SAVR. Four studies included intermediate-risk patients and seven high-risk patients. Mean age was 76 and 71.5 years in the ViV and re-SAVR group respectively, with a 60.2% and 61.3% of male. For the ViV procedure, BE prostheses were used in the 49.6% of patients and SE prostheses in the 45.8%. The ViV group have higher prevalence of previous CAD (53.8% vs 41.1%) and CABG (35% vs 23.6%) and more history of HF (72.1% vs 65.6%), CKD (26.6% vs 14.8%) and COPD (25.4 vs 14.8%). 30-day all-cause and CV mortality were significantly lower in ViV (OR 0.43, 0.29–0.64 and OR 0.44, 0.26–0.73 respectively), while after a mean follow-up of 717 (180–1825) days, there were no difference between the two groups (OR 1.04, 0.87–1.25 and OR 1.05, 0.78–1.43 respectively). The result were consistent both in intermediate and high-risk classes. The risk of stroke (OR 1.03, 0.59–1.82), MI (OR 0.70, 0.34–1.44), major vascular complications (OR 0.92, 0.50–1.67) and permanent pacemaker implantation (OR 0.67, 0.36–1.25) at 30 days did not differ, while major bleedings and new onset atrial fibrillation were significantly lower in ViV patients (OR 0.41, 0.25–0.67 and OR 0.23, 0.12–0.42 respectively, all CI 95%). Conclusions In patients with a degenerated aortic bioprosthesis, ViV TAVI is associated with better short-term outcomes, including all-cause mortality, without any difference in all-cause and cardiovascular mortality at mid-term follow-up compared to surgical redo. Funding Acknowledgement Type of funding sources: None.

Late Clinical and Hemodynamic Outcomes in patients with degenerated bioprosthetic aortic valves undergoing transcatheter valve-in-valve implantation

Abstract Background Clinical studies have shown promising early outcomes for valve-in-valve transcatheter aortic valve implantation (ViV-TAVI); however, the late outcomes of this procedure remain under-investigated. Purpose We performed the present analysis to assess the late clinical and hemodynamic outcomes of ViV-TAVI in patients with degenerated bioprosthetic aortic valves. Methods A comprehensive chart review was performed for eligible patients to retrieve data on procedural characteristics, admission details following the procedure, and echocardiographic parameters. Clinical outcomes included all-cause mortality, heart failure hospitalization and structural valve deterioration (SVD), as defined by VARC-II criteria, up to 5 years of follow-up. To assess the trends in mean and peak transvalvular gradients, data from the follow-up echocardiographic reports were analyzed using Syngo Dynamics imaging software. Results A total of 188 patients were included with a mean age of 75.8±10.4 years. Balloon- and self-expandable valves were used in 155 (82.4%) and 33 (17.6%) patients, respectively. At 30 days, 3 (1.6%) patients died and 8 (4.2%) required hospitalization for heart failure, while at 5 years, both events were recorded in 29 (15.4%) and 37 (19.7) patients, respectively. Kaplan-Meier survival analysis showed that patients with smaller surgical valves (internal diameter ≤21 mm) had a significantly higher mortality rate (log-rank p=0.021) than those with larger valves; however, no significant difference (log-rank p=0.59) was detected between different transcatheter valves (self vs. balloon-expandable). Three patients underwent re-intervention, performed via a transcatheter approach. Further, assessment of follow-up echocardiographic reports revealed 9 (4.8%) cases of SVD, as well as stable mean (16.3±6.9 at discharge and 16.9±11.3) and peak (30.3±12.1 at discharge and 30.7±18.4 at 5 years) transvalvular gradients. No difference (p&amp;gt;0.05) was observed based on transcatheter valve type or surgical valve internal diameter in terms of mean and peak transvalvular gradients throughout the follow-up period. Conclusion The present study showed good clinical outcomes among patients undergoing VIV-TAVI, with stable VIV performance over a five-year period. Future long-term studies are warranted to analyze the predictors of outcomes following ViV-TAVI and explore the role of this treatment option in the life-long management of aortic stenosis. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Jennifer and Robert McNeil Donation to the Heart, Thoracic, and Vascular Institute at Cleveland Clinic. Figure 1

Long term outcomes of patients with aortic structural valve deterioration treated with transcatheter valve in valve implantation

Abstract Introduction The Valve-in-Valve (ViV) technique is an established alternative for the treatment of structural bioprosthetic valve deterioration (SVD). Data describing the long term follow up of patients treated with this approach is scarce. We report on our long-term follow up outcomes of patients with SVD in the Aortic position treated with ViV. Methods Included were patients with symptomatic SVD in the aortic position valve who were treated by Valve in valve transcatheter aortic valve implantation (ViV-TAVI) during the years 20102019 in our center. Three main outcomes were examined during follow up: NYHA functional class, hemodynamic of the VIV-TAVI per echocardiography, and overall mortality. Results Our cohort consisted of 84 patients (mean age 78.8±8.9 years). The indications for aortic ViV were: SVD isolated aortic stenosis in 37.6%, SVD isolated aortic regurgitation in 42.2% and combined valve pathology in 20.0%. Self-expandable and balloon-expandable devices were used in 73 (85.9%) and 12 (14.1%), respectively. Average time of follow up was 3.74±2.4 years. 95% and 91% of patients were in NYHA functional class I/II at 1 and 5 year follow up respectively. At one year the mean trans-aortic valve pressure was 15.3±9.3 and rates of ≥ moderate aortic regurgitation were 3.7%. Survival was 91.4% (95% CI 85.6–97.7) at one year and 79.5% (95% CI 70.2–90.0) at 3 years. Conclusion ViV in the aortic position offers an effective and durable treatment option for patient with SVD, with low rates of all-cause mortality, excellent hemodynamic and improved functional capacity at 3 years follow up. Funding Acknowledgement Type of funding sources: None. NYHA functional class over follow up

High-degree atrioventricular block after valve-in-valve transcatheter aortic valve implantation: incidence and predictors

Abstract Background High-degree atrioventricular (AV) block and permanent pacemaker (PPM) implantation represent major complications after transcatheter aortic valve implantation (TAVI). Data on the incidence of AV block for patients undergoing valve-in-valve (ViV) TAVI are scarce. We examined the incidence and predictors of periinterventional AV conduction disturbances in a cohort of subjects undergoing ViV TAVI compared to subjects undergoing TAVI of native aortic valves. Methods In 50 consecutive patients who underwent ViV TAVI, clinical characteristics, incidence and predictors for AV conduction disturbances as well as intrahospital outcome were assessed. Applying a matched pair approach for age, gender, type and size of transcatheter valve, these subjects were compared to 50 patients undergoing TAVI of native tricuspid aortic valves. Results Mean age in both groups was 80±6 years and 50% of subjects were male. In the ViV group, 22 patients (44%) had a stented bioprosthesis, 10 patients (20%) a stentless bioprosthesis and 18 patients (36%) a previous TAVI prosthesis (balloon-expandable: n=15, self-expandable n=3). The majority of subjects (92% in each group) were treated using balloon-expandable valves (ViV group: Sapien XT, n=20 or Sapien 3, n=26, control group: Sapien XT, n=19 or Sapien 3, n=27). Periinterventional, non-reversible 3rd degree AV-block occurred in 6 patients within each group (12%), and all of the affected patients underwent PPM implantation. Among the 32 patients who underwent ViV-TAVI of a surgically placed bioprosthesis, only 2 (6%) developed a high-degree AV block (1/22 with a stented bioprosthesis and 1/10 with a stentless bioprosthesis). In contrast, high-degree AV block occurred in 4/18 patients (22%) who underwent ViV TAVI of a prior TAVI prosthesis. There was a significant difference in the occurrence of total high-degree AV blocks requiring postinterventional PPM implantation (p=0.033) between subjects who received TAVI of stented bioprostheses and those who received re-TAVI. In logistic regression analysis, pre-existing RBBB represented a significant predictor for periinterventional 3rd degree AV block across the whole cohort (p=0.001, Exp(B)=10.667), both in ViV subjects (p=0.016, Exp(B)=12.0) and in the control group (p=0.018, Exp(B)=10.0). Conclusion Periinterventional AV block occurs infrequently in subjects undergoing ViV TAVI for treatment of degenerated surgical bioprostheses. However, patients undergoing ViV TAVI for degenerated transcatheter prostheses as well as subjects with pre-existing RBBB are at substantial risk for the occurence of AV block and require close peri-interventional monitoring. Funding Acknowledgement Type of funding sources: None.

Bioprosthetic valve fracture for valve‐in‐valve transcatheter aortic valve implantation in patients with structural valve degeneration: Systematic review with meta‐analysis

To determine the outcomes of bioprosthetic valve fracture (BVF) in valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) for patients with structural valve degeneration (SVD) of bioprosthetic surgical valves (BSV) implanted during surgical aortic valve replacement (SAVR). A systematic review was conducted including studies published by May 2021. The primary endpoints of the study were 30-day mortality, annular rupture, stroke, paravalvular leak, pacemaker implantation, and coronary obstruction. The secondary endpoints were mean valve gradients (mmHg) and aortic valve area (AVA-cm2 ). A meta-analysis was conducted using the software R, version 3.6.3 (R Foundation for Statistical Computing). Four studies including 242 patients met our eligibility criteria. The overall proportions for 30-day mortality, annular rupture, stroke, paravalvular leak, pacemaker implantation and coronary obstruction were 2.1%, <1.0%, <1.5%, <1.0%, <1.0%, and <1.5%, respectively. After ViV-TAVI with BVF, the difference in means for mean valve gradients showed a significant reduction (random-effects model: -26.7; -28.8 to -24.7; p < .001), whereas the difference in means for AVA showed a significant increase (random-effects model: 0.55 cm2 ; 0.13-0.97; p = .029). Despite the improvement in AVA means, these remain too low after the procedure highly likely due to the small size of the bioprosthetic valves implanted during the index SAVR. ViV-TAVI with BVF has proven to be a promising option but data are still too scarce to enable us to draw definitive conclusions. Despite the decrease in gradients, postprocedural AVA remains worrisome. Studies with better designs and larger sample sizes are needed to advance this treatment option.

Predictors of Procedural Success in Patients With Degenerated Surgical Valves Undergoing Transcatheter Aortic Valve-in-Valve Implantation

Background: Valve-in-Valve transcatheter aortic valve implantation (ViV-TAVI) is a growing alternative for redo-surgery in patients with degenerated surgical valves. To our knowledge, data are lacking on the determinants on ViV-TAVI procedural success in patients with degenerated surgical valves.Methods: All consecutive patients undergoing ViV-TAVI for degenerated surgical valves at the Cleveland Clinic were analyzed. Data were extracted from our patient registry on baseline patient characteristics, echocardiographic parameters, and procedural details. To identify possible predictors of ViV-TAVI procedural success, we employed a multivariate logistic regression model.Results: A total of 186 patients who underwent ViV-TAVI were analyzed, with procedural success (VARC-2 device success and absence of periprocedural MACCE) reported in 165 (88.7%) patients. Patients with successful ViV-TAVI were significantly younger and had more frequent utilization of the transfemoral access than those with failed procedure. Other baseline and procedural characteristics were comparable between both groups. In terms of echocardiographic parameters, the procedural success group had a significantly lower AV peak pressure gradient (62.1 ± 24.7 vs. 74.1 ± 34.6 mmHg; p = 0.04) and lower incidence of moderate-to-severe aortic regurgitation [AR] (30.4 vs. 55%; p = 0.04). However, no significant differences between both groups were noted in terms of AV mean pressure gradient and left ventricular measurements. In multivariate analysis, lower AV peak pressure gradient (OR = 0.97, 95% CI: 0.95–0.99) and absence of moderate-to-severe AR (OR = 0.65, 95% CI: 0.44–0.95) at baseline emerged as independent predictors of ViV-TAVI procedural success.Conclusion: Valve-in-Valve TAVI for degenerated surgical valves is a feasible approach with high success rates, especially in those with lower AV peak pressure gradient and absence of moderate-to-severe AR. Studies with larger sample size and longer follow-up are required to further characterize the predictors of ViV-TAVI success and other clinical outcomes.

5 Year Outcomes of Patients With Aortic Structural Valve Deterioration Treated With Transcatheter Valve in Valve - A Single Center Prospective Registry.

The Valve-in-Valve (ViV) technique is an established alternative for the treatment of structural bioprosthetic valve deterioration (SVD). Data describing the intermediate term follow up of patients treated with this approach is scarce. We report on our intermediate-term outcomes of patients with SVD in the Aortic position treated with ViV. Included were patients with symptomatic SVD in the aortic position valve who were treated by Valve in valve transcatheter aortic valve implantation (ViV-TAVI) during the years 2010-2019 in our center. Three main outcomes were examined during the follow up period: NYHA functional class, ViV-TAVI hemodynamic per echocardiography, and mortality. Our cohort consisted of 85 patients (mean age 78.8 ± 8.9 years). The indications for aortic ViV were: SVD isolated aortic stenosis in 37.6%, SVD isolated aortic regurgitation in 42.2% and combined valve pathology in 20.0%. Self-expandable and balloon-expandable devices were used in 73 (85.9%) and 12 (14.1%), respectively. Average follow up was 3.7 ± 2.4 years. 95 and 91% of patients were in NYHA functional class I/II at 1 and 5 year follow up respectively. At one year, the mean trans-aortic valve pressure was 15 ± 9 mmHg and rates of ≥ moderate aortic regurgitation were 3.7%. Mortality at one year was 8.6% (95% CI 2.3–14.4) and 31% (95% CI 16.5–42.5) at 5 years. ViV in the aortic position offers an effective and durable treatment option for patient with SVD, with low rates of all-cause mortality, excellent hemodynamic and improved functional capacity at intermediate follow up.