Significant Paravalvular Leak Research Articles

Long-term outcomes of aortic stenosis patients with different flow/gradient patterns undergoing transcatheter aortic valve implantation

Abstract Background Few data exist on the comparative long-term outcomes of severe aortic stenosis (AS) patients with different flow-gradient patterns undergoing transcatheter aortic valve implantation (TAVI). This study sought to evaluate the impact of the pre-TAVI flow-gradient pattern on long-term clinical outcomes after TAVI. Methods Consecutive patients with severe AS undergoing TAVI in our institution were screened and prospectively enrolled. Patients were divided into four subgroups according to pre-TAVI flow/gradient pattern: (i) low flow—low gradient (LF-LG): stroke volume indexed (SVi) ≤ 35 mL/m2 and mean gradient (MG) < 40 mmHg); (ii) normal flow—low gradient (NF-LG): SVi > 35 mL/m2 and MG < 40 mmHg; (iii) low flow—high gradient (LF-HG): Svi 35 mL/m2 and MG ≥ 40 mmHg and (iv) normal flow—high gradient (NF-HG): SVi > 35 mL/m2 and MG ≥ 40 mmHg. Clinical follow-up was obtained at 12 months, and yearly thereafter until 5-year follow-up was complete for all patients. Results A total of 272 patients with complete echocardiographic and clinical follow-up were included in our analysis. Their mean age was 80 ± 7 years and the majority of patients (N = 138, 50.8%) were women. 62 patients (22.8% of the study population) were distributed in the LF-LG group, 98 patients (36%) were LF-HG patients, 95 patients (34.9%) were NF-HG, and 17 patients (6.3%) were NF-LG. There was a greater prevalence of comorbidities among LF-LG AS patients. One-year all-cause mortality differed significantly between the four subgroups of AS patients (log-rank p: 0.022) and was more prevalent among LF-LG patients (25.8%) compared to LF-HG (11.3%), NF-HG (6.3%) and NF-LG patients (18.8%). At 5-year follow-up, global mortality remained persistently higher among LF-LG patients (64.5%) compared to LF-HG (47.9%), NF-HG (42.9%), and NF-LG patients (58.8%) (log-rank p: 0.029) (Figure 1). At multivariable Cox hazard regression analysis, baseline SVi (HR: 0.951, 95% C.I.; 0.918–0.984), the presence of at least moderate tricuspid regurgitation at baseline (HR: 3.091, 95% C.I: 1.645–5.809) and at least moderate paravalvular leak (PVL) post-TAVI (HR: 1.456, 95% C.I.: 1.106–1.792) were significant independent predictors of late global mortality. Conclusions Patients with LF-LG AS have acceptable 1-year outcomes, but exhibit exceedingly high 5-year mortality following TAVI. The presence of low transvalvular flow and at least moderate tricuspid regurgitation at baseline and significant paravalvular leak post-TAVI were associated with poorer long-term outcomes in the entire cohort of AS patients.

CT-derived simulations to predict outcomes in patients undergoing transcatheter aortic valve implantation with an ACURATE Neo2 valve the PRECISE-TAVI cohort B trial.

Paravalvular leakage (PVL) and conduction disorders that require permanent pacemaker implantation (PPI) remain clinically relevant challenges after transcatheter aortic valve implantation (TAVI). Computed tomography-based simulations may predict the risk of significant PVL and PPI. To evaluate the feasibility and accuracy of preprocedural computer simulation with FEops HEARTguide™ to predict >trace PVL and PPI after TAVI with the self-expanding supra-annular ACURATE Neo2 transcatheter heart valve. Prospective multicenter observational study that included consecutive patients undergoing TAVI with an ACURATE Neo2 valve. Computer simulations were performed before the TAVI procedure as part of the preprocedural planning. Follow-up period for PPI and PVL was 30 days. Sixty-five patients were included (median age 81 years (25th-75th percentile 77-84.5)). New left bundle branch block occurred in five patients (7.7%) and PPI in two patients (3%). Contact pressure index (CPI) was similar for patients with vs without new conduction disorders. Patients with PPI had numerically higher CPI than those without PPI (median CPI 20.0% (25th-75th percentile 15.0-25.0) vs. 13.0% (25th-75th percentile 5.5-18), p = 0.27). More than trace PVL occurred in 30%. Median PVL was significantly lower in patients with none-trace PVL (3.2 mL/s [25th-75th percentile 2.2-5.0]), compared to mild PVL (5.2 mL/s [25th-75th percentile 3.2-10.3]) and moderate PVL (12.6 mL/s [25th-75th percentile 3.9-21.3])(p = 0.036). A simulated PVL-cutoff of 9.65 mL/s identified patients with >trace PVL (AUC 0.70 (95% CI 0.55-0.85), sensitivity 42%, specificity 95%). In our study FEops HEARTguide™ simulations identified patients at risk for >trace PVL with ACURATE Neo2 TAVI but not for PPI.

Long-Term Outcomes of Aortic Stenosis Patients with Different Flow/Gradient Patterns Undergoing Transcatheter Aortic Valve Implantation.

Background: Few data exist on the comparative long-term outcomes of severe aortic stenosis (AS) patients with different flow-gradient patterns undergoing transcatheter aortic valve implantation (TAVI). This study sought to evaluate the impact of the pre-TAVI flow-gradient pattern on long-term clinical outcomes after TAVI and assess changes in the left ventricular ejection fraction (LVEF) of different subtypes of AS patients following TAVI. Methods: Consecutive patients with severe AS undergoing TAVI in our institution were screened and prospectively enrolled. Patients were divided into four subgroups according to pre-TAVI flow/gradient pattern: (i) low flow-low gradient (LF-LG): stroke volume indexed (SVi) ≤ 35 mL/m2 and mean gradient (MG) < 40 mmHg); (ii) normal flow-low gradient (NF-LG): SVi > 35 mL/m2 and MG < 40 mmHg; (iii) low flow-high gradient (LF-HG): Svi 35 mL/m2 and MG ≥ 40 mmHg and (iv) normal flow-high gradient (NF-HG): SVi > 35 mL/m2 and MG ≥ 40 mmHg. Transthoracic echocardiography was repeated at 1-year follow-up. Clinical follow-up was obtained at 12 months, and yearly thereafter until 5-year follow-up was complete for all patients. Results: A total of 272 patients with complete echocardiographic and clinical follow-up were included in our analysis. Their mean age was 80 ± 7 years and the majority of patients (N = 138, 50.8%) were women. 62 patients (22.8% of the study population) were distributed in the LF-LG group, 98 patients (36%) were LF-HG patients, 95 patients (34.9%) were NF-HG, and 17 patients (6.3%) were NF-LG. There was a greater prevalence of comorbidities among LF-LG AS patients. One-year all-cause mortality differed significantly between the four subgroups of AS patients (log-rank p: 0.022) and was more prevalent among LF-LG patients (25.8%) compared to LF-HG (11.3%), NF-HG (6.3%) and NF-LG patients (18.8%). At 5-year follow-up, global mortality remained persistently higher among LF-LG patients (64.5%) compared to LF-HG (47.9%), NF-HG (42.9%), and NF-LG patients (58.8%) (log-rank p: 0.029). At multivariable Cox hazard regression analysis, baseline SVi (HR: 0.951, 95% C.I.; 0.918-0.984), the presence of at least moderate tricuspid regurgitation at baseline (HR: 3.091, 95% C.I: 1.645-5.809) and at least moderate paravalvular leak (PVL) post-TAVI (HR: 1.456, 95% C.I.: 1.106-1.792) were significant independent predictors of late global mortality. LF-LG patients and LF-HG patients exhibited a significant increase in LVEF at 1-year follow-up. A lower LVEF (p < 0.001) and a lower Svi (p < 0.001) at baseline were associated with LVEF improvement at 1-year. Conclusions: Patients with LF-LG AS have acceptable 1-year outcomes with significant improvement in LVEF at 1-year follow-up, but exhibit exceedingly high 5-year mortality following TAVI. The presence of low transvalvular flow and at least moderate tricuspid regurgitation at baseline and significant paravalvular leak post-TAVI were associated with poorer long-term outcomes in the entire cohort of AS patients. The presence of a low LVEF or a low SVi predicts LVEF improvement at 1-year.

Impact of prosthesis oversizing on clinical outcomes of transcatheter aortic valve implantation using a self-expandable Evolut R valve

BackgroundTranscatheter Aortic Valve Implantation (TAVI) has a growing target population after being indicated even in low-surgical-risk patients with severe symptomatic aortic stenosis. However, postoperative outcomes can be compromised due to para-valvular leakage (PVL). A lot of procedural steps have been investigated to decrease this partially avoidable operational hazard. Oversizing is a main technique to decrease the PVL, despite being itself a risky step. Many studies have been conducted to identify the optimum degree of oversizing. However, studies about oversizing by more than 20% are scarce. We aimed to evaluate the safety and efficacy of oversizing equal to or more than 20%.Results209 patients who underwent TAVI using the self-expandable valve Evolut R were initially included. 66 patients were excluded because of the baseline conduction disturbance and lack of sufficient data, so 143 patients, 60 females and 83 males, were enrolled in our study as two groups based on the degree of oversizing: Group A included 97 patients with an oversizing index (OI) of less than 20%, and Group B included 46 patients with an OI of 20% or more. We conducted a new technique for more accurate measuring of the OI in the context of the implantation depth, and our patients were categorized using this technique. Our findings have met our primary end point in terms of the safety and efficacy of oversizing by 20% or more. There was no significant difference between both groups in terms of new-onset conduction disturbance (NOCD), with zero cases of annular rupture or coronary encroachment. In terms of efficacy, The incidence of significant PVL (grade 2 or more) in group B was less than in group A (P value 0.007). The ROC curve found that the minimum depth of implantation-derived oversizing (DIDO) to predict no significant PVL was less than 17%.ConclusionProsthesis oversizing by 20% using the self-expandable Evolut R valve is safe and effective, with no significant effect on the conduction system, coronary encroachment, or annular injury, and warrants a greater reduction in the incidence of significant PVL.

Impact of left ventricular end-diastolic pressure as a marker for diastolic dysfunction on long-term outcomes in patients undergoing transcatheter aortic valve replacement

ObjectiveThe aim of this study was to investigate the proportion of elevated left ventricular end-diastolic pressure (LVEDP) as an indicator of diastolic function after transcatheter aortic valve replacement (TAVR) and its implication in predicting long-term mortality. MethodsWe analyzed retrospectively collected data on 3328 patients with severe aortic stenosis undergoing TAVR in our institution between July 2009 and June 2021. Patients were stratified into two groups based on invasive post-procedural LVEDP measurements: normal (<15 mmHg) vs. elevated (≥15 mmHg) LVEDP. ResultsMean age of the patients was 81.6 years, and 53.3% were female. Elevated post-procedural LVEDP was identified in 2408 (72.3%) patients. The 5-year mortality rates were higher in the group with elevated LVEDP compared with the group with normal LVEDP (27.4% vs. 8.3%, p = 0.01; hazard ratio [HR] 1.22, 95% CI 1.05-1.41). A multivariate model revealed the following independent predictors of mortality after TAVR: post-procedural elevated LVEDP (HR 1.24, 95% CI 1.01-1.53), pre-procedural significant tricuspid regurgitation (HR 1.24, 95% CI 1.02-1.52) and pulmonary hypertension (PH) (HR 1.53, 95% CI 1.26-1.86). In the present study, a significant paravalvular leak after TAVR was not associated with higher mortality (HR 1.45, 95% CI-0.95-2.19, p = 0.75). ConclusionElevated post-procedural LVEDP in patients who undergo TAVR is an independent predictor of all-cause mortality. Furthermore, PH and tricuspid regurgitation were also identified as predictors of mortality. These data confirm that diastolic dysfunction is an important predictor of mortality in TAVR and should be considered to guide procedure timing, favoring an early interventional approach and management in aortic stenosis patients.

Minimally Invasive Surgical Versus Transcatheter Aortic Valve Replacement: A Retrospective Observational Single-Center Study in Japan.

This study aimed to compare the outcomes of minimally invasive aortic valve replacement (MICS-AVR) versus transfemoral transcatheter aortic valve replacement (TF-TAVR) in Asian patients. We conducted a retrospective, observational, single-center study in Japan, including cases of MICS-AVR (n = 202) and TF-TAVR (n = 248) between 2014 and 2021. In a total of 450 cases, propensity score matching was performed at a ratio of 1:1, resulting in 96 pairs. Furthermore, we performed competing-risk regression and mediation analyses to determine the treatment effect on outcomes of interests, considering death as a competing risk, and to evaluate the mediation effect of paravalvular leak (PVL) severity. There were similar incidences of all-cause death, cardiac death, stroke and cerebral hemorrhage, and aortic valve reintervention between the 2 groups. However, the TF-TAVR cohort had a longer hospital length of stay and higher rates of significant PVL compared with the MICS-AVR cohort. Multivariable-adjusted Cox regression analyses revealed that heart failure hospitalization (hazard ratio [HR] = 0.129, 95% confidence interval [CI]: 0.038 to 0.445, p = 0.001) and permanent pacemaker implantation (HR = 0.050, 95% CI: 0.006 to 0.409, p = 0.005) favored MICS-AVR. Competing-risk regression analyses confirmed similar findings. All outcomes were unrelated to PVL severity. To our knowledge, this is the first comparative study of clinical outcomes in Asian patients undergoing MICS-AVR versus TF-TAVR, revealing that MICS-AVR could be a feasible and efficient alternative to TF-TAVR. Future larger-scale randomized controlled trials are needed to validate the present results.

Comparison of Paravalvular Leak in SAPIEN 3 and EVOLUT PRO Valves in Transcatheter Aortic Valve Replacement: A Multicenter Registry

Paravalvular leak (PVL), conduction disturbances, and vascular complications remain the most common complications after TAVR. To address these adverse outcomes, the third generation of transcatheter heart valves has been developed. The last generation prosthesis provides an outer pericardial wrap for enhanced sealing and PVL prevention. This study aimed to compare the incidence and severity of PVL and 1-year survival after TAVR using SAPIEN 3 with those using EVOLUT PRO. An observational retrospective analysis was conducted in 1,481 patients who underwent TAVR for symptomatic severe aortic stenosis in 6 different European centers. The primary end point was to assess the frequency and severity of PVL at 30 days after TAVR. The secondary end point was to compare 1-year survival using EVOLUT PRO with that using SAPIEN 3. SAPIEN 3 transcatheter heart valve was implanted in 78.3% of study participants (n=1,160) whereas EVOLUT PRO was implanted in 21.7% (n=321). PVL is more commonly observed in patients treated with EVOLUT PRO at prehospital discharge (55.1% vs 37.3%) and at 1-month (51% vs 41.4%) and 1-year (51.3% vs 39.3%) follow-up. This difference mainly concerns low-grade (mild/trace) PVL. The frequency of high-degree (moderate/severe) PVL was almost similar in both groups throughout the study period (5.3% vs 5.8% before hospital discharge, 4% vs 3.1% at 1 month, and 3.2% vs 4.9% at 1 year). No significant difference in survival over 1 year has been observed (hazard ratio 0.73 [0.33 to 1.63], p=0.442) (Graphical abstract). In conclusion, the detection rate of PVL after TAVR with third-generation heart valves remains high, and there are no major differences between the devices regarding the frequency of significant (moderate/severe) PVL and survival.

Extrathoracic Against Intrathoracic Vascular Accesses for Transcatheter Aortic Valve Replacement: A Systematic Review With Meta-Analysis

Alternative vascular accesses to transfemoral access for transcatheter aortic valve replacement (TAVR) can be divided into intrathoracic (IT)-transapical and transaortic- and extrathoracic (ET)-transcarotid, transsubclavian, and transaxillary. This study aimed to compare the outcomes and safety of IT and ET accesses for TAVR as alternatives to transfemoral access. A systematic review with meta-analysis was performed by searching PubMed/MEDLINE and EMBASE databases for all studies comparing IT-TAVR with ET-TAVR published until April 2023. Outcomes included in-hospital or 30-day all-cause mortality (ACM), 1-year ACM, postoperative and 30-day complications. A total of 18 studies with 6,800 IT-TAVR patients and 5,032 ET-TAVR patients were included. IT accesses were associated with a significantly higher risk of in-hospital or 30-day ACM (relative risk 1.99, 95% confidence interval 1.67 to 2.36, p <0.001), and 1-year ACM (relative risk 1.31, 95% confidence interval 1.21 to 1.42, p <0.001). IT-TAVR patients presented more often with postoperative life-threatening bleeding, 30-day new-onset atrial fibrillation or flutter, and 30-day acute kidney injury needing renal replacement therapy. The risks of postoperative permanent pacemaker implantation and significant paravalvular leak were lower with IT-TAVR. ET-TAVR patients were more likely to be directly discharged home. There was no statistically significant difference regarding the 30-day risk of stroke. Compared with ET-TAVR, IT-TAVR was associated with higher risks of in-hospital or 30-day ACM, 1-year ACM and higher risks for some critical postprocedural and 30-day complications. Our results suggest that ET-TAVR could be considered as the first-choice alternative approach when transfemoral access is contraindicated.

Transcatheter aortic valve-in-valve implantation within stentless landing zones: Procedural insights from a single-center experience.

Valve-in-valve (VIV) transcatheter aortic valve implantation (TAVI) is a less invasive therapeutic option compared with redo surgical valve replacement for high-risk patients. Relative to procedures within stented surgical valves, VIV-TAVI within stentless valves is associated with a higher complication rate due to challenging underlying anatomy and absence of fluoroscopic landmarks. We share a single-center experience with VIV-TAVI in stentless valves, discussing our procedural insights and associated outcomes. Our institutional database was queried, and 25 patients who had undergone VIV-TAVI within a stentless bioprosthesis, homograft, or valve-sparing aortic root replacement between 2013 and 2022 were found. Outcome endpoints were based on the Valve Academic Research Consortium-3 criteria. The mean age of the cohort was 69.5 ± 13.6 years. VIV implantation was performed within a homograft in 11 patients, a stentless bioprothesis in 10 patients, and a valve-sparing aortic root replacement in 4 patients. Nineteen (76%) balloon-expandable valves, 5 (20%) self-expanding valves, and one mechanically-expandable (4%) valve were implanted with 100% procedural success, with no instances of significant paravalvular leak, coronary occlusion, or device embolization. There was one (4%) in-hospitality mortality after an emergency procedure; one (4%) patient experienced a transient ischemic attack; and two (8%) patients required permanent pacemaker implantation. The median length of hospital stay was 2 days. After a median follow-up time of 16.5 months, valve function was acceptable in all patients with available data. VIV-TAVI within stentless valves can be safely performed with methodical procedural technique and can provide clinical benefit in patients at high reoperation risk.

Multimodality imaging (3D Echocardiography, 3D printing and confocal microscopy) for paravalvular leak visualization

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – EU funding. Main funding source(s): National Center for Research and Development as part of the strategic program "Prevention and treatment of civilization diseases" Strategmed II Project "Integrated paravalvular leak closure system" -acronym VALE, Paravalvular leak (PVL) may occur in 15% of patients undergoing surgical mitral valve replacement. Visualization of PVL channels may be challenging due to its proximity to the prosthetic valve and complex anatomy. The main aim of this study was to use a confocal microscope to measure PVL channel dimensions. With 3D-TEE (Philips Epiq) an anteromedial mitral defect was visualized. Qlab Station was used to export the 3D recording of the PVL with surrounding tissue in cartesian DICOM format. Next Slicer, a free open-source software, was used for segmentation and preparation of a STL (stereolithography) file. The PVL model was printed with Starsys Object 30 printer using Med620 material. PVL diameters were measured both after MPR of source echocardiographic data and in the printed model with a confocal microscope. The same results were obtained. Thus, the possibility of using the standard 3D-TEE and open source software for preparation of 3D models of anatomically complex mitral PVLs was confirmed. In addition, a confocal microscope can be used to measure PVL dimensions of models printed from echocardiographic data. Background Paravalvular leak (PVL) may occur in almost 15% of patients undergoing surgical mitral valve replacement. This complication can cause patient’s significant deterioration (congestive heart failure and hemolysis). Visualization of PVL channel may be challenging due to its proximity to prosthetic valve (shadowing) and complex and tortuos anatomy. 3D imaging from CT and echocardiography is essential for assessment of PVLs. 3D-TEE-based 3D-printing might be useful in preprocedural planning of PVL closure for the optimization of transcatether procedures. As feasibility of such printing is proven, now we are looking for best techniques to measure PVL channels. Purpose Confocal microscope appliance to measure PVL chanel dimensions Methods In case of a significant PVL around a mitral prosthetic valve is presented. In 3DTEE (Philips Epiq) anteromedial defects were visualized (surgical view). Qlab Station was used to export the 3D recording of PVLs with surrounding tissue in cartesian DICOM format. Next Slicer, a free open-source software, was used for segmentation and preparation of a STL (stereolithography) file. The PVL model was printed with Starsys Object 30 printer using Med620 material. PVL diameters were measured in MPR from 3D Echocardiography and after analysis in confocal microscope at printed model. Measurements were the same 10/5 mm. Results Confocal microscope can be used to measure PVL dimensions from printed models from echocardiography. Figure1 MPR 2D measurements of PVLs, and printed model of PVL. Figure 2 Measurements form confocal microscope. Conclusion(s) Proof of concept study confirms feasibility of using multimodality imagine for measurements of PVL. Further studies to assess clinical applicability of the presented methodology are ongoing.

Quantity and location of aortic valve calcification predicts paravalvular leakage after transcatheter aortic valve replacement: a systematic review and meta-analysis.

Transcatheter aortic valve replacement (TAVR) is the first-line treatment for patients with moderate-to-high surgical risk of severe aortic stenosis. Paravalvular leakage (PVL) is a serious complication of TAVR, and aortic valve calcification contributes to the occurrence of PVL. This study aimed to investigate the effect of location and quantity of calcification in the aortic valve complex (AVC) and left ventricular outflow tract (LVOT) on PVL after TAVR. We performed a systematic review and meta-analysis to evaluate the effect of quantity and location of aortic valve calcification on PVL after TAVR using observational studies from PubMed and EMBASE databases from inception to February 16, 2022. Twenty-four observational studies with 6,846 patients were included in the analysis. A high quantity of calcium was observed in 29.6% of the patients; they showed a higher risk of significant PVL. There was heterogeneity between studies (I2 = 15%). In the subgroup analysis, PVL after TAVR was associated with the quantity of aortic valve calcification, especially those located in the LVOT, valve leaflets, and the device landing zone. A high quantity of calcium was associated with PVL, regardless of expandable types or MDCT thresholds used. However, for valves with sealing skirt, the amount of calcium has no significant effect on the incidence of PVL. Our study elucidated the effect of aortic valve calcification on PVL and showed that the quantity and location of aortic valve calcification can help predict PVL. Furthermore, our results provide a reference for the selection of MDCT thresholds before TAVR. We also showed that balloon-expandable valves may not be effective in patients with high calcification, and valves with sealing skirts instead of those without sealing skirts should be applied more to prevent PVL from happening. https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=354630, identifier: CRD42022354630.

Two innovative aortic bioprostheses evaluated in the real-world setting. First results from a two-center study.

The increasing use of biological substitutes for surgical aortic valve replacement (AVR), has led to the development of new bioprostheses with improved hemodynamics and expected durability. In this observational retrospective two-center cohort study, two innovative bioprostheses, INSPIRIS Resilia and AVALUS were analyzed. We analyzed early and 2.4-year follow-up results in terms of safety, clinical outcome and hemodynamic performance. From November 2017 to February 2021, 148 patients underwent AVR with INSPIRIS Resilia (N.=74) or AVALUS (N.=74) bioprosthesis. The 30-day and mid-term mortality was comparable (1% vs. 3%, P=0.1 and 7% vs. 4%, P=0.4, respectively). Valve-related mortality was observed in one AVALUS patient. Three (4%) patients of the AVALUS group developed prosthetic endocarditis and two of them died after reoperation. No other cases of prosthetic endocarditis were observed. No cases of structural valve degeneration or significant paravalvular leak were detected at follow-up. Median follow-up peak pressure gradient was 21 vs. 23 mmHg (P=0.4) and the mean pressure gradient was 12 vs. 13 mmHg (P=0.9) for Inspiris and AVALUS, respectively. The effective orifice area (EOA) and indexed EOA were 1.5 cm2 vs. 1.4 cm2 (P=0.4) and 0.8 vs. 0.7 cm2/m2 (P=0.5), respectively. Indexed left ventricular mass regression was -33 vs. -52 g/m2 for the Inspiris and AVALUS groups, respectively, (R2-adjusted =0.14; P<0.01). INSPIRIS Resilia and AVALUS bioprostheses were reliable with comparable results in safety, clinical outcome and hemodynamic performance. After statistical adjustment, AVALUS was associated with better left ventricular mass reduction. Long-term follow-up would provide definitive comparative results.

Left Axillary Access for Transcatheter Aortic Valve Implantation in a Patient With Two Dependent Internal Mammary Artery Grafts and a Permanent Left-Sided Implanted Pacemaker

Transfemoral access has been established as the gold standard approach for the majority of patients undergoing transcatheter aortic valve implantation (TAVI). However, in cases with anatomical difficulties or severely diffused peripheral arterial disease, alternative vascular access may be considered such as the transaxillary approach. We present the case of a 92-year-old gentleman with exertional dyspnea due to severe symptomatic aortic stenosis and a history of peripheral femoro-femoral bypass surgery, coronary arterial bypass surgery and a permanent dual-chamber left-side implanted pacemaker. Due to the high surgical risk and the severe anatomical difficulties, the method of TAVI using the left axillary approach was opted. A 14-F vascular sheath was inserted with surgical cutdown and with fluoroscopic guidance while small injections of contrast confirmed the non-occlusive position and the patency of the left internal mammary artery (LIMA) graft. A stiff guidewire was used to cross the heavily calcified aortic valve and subsequently was placed into the left ventricle. Balloon aortic valvuloplasty was performed followed by a successful TAVI with no significant aortic regurgitation or paravalvular leak. The patient recuperated uneventfully and was discharged after 72 h. Axillary access for TAVI is a feasible option for high-risk patients with extended peripheral arteriopathy. To our knowledge this is the first case report describing the implantation of a newer type of intra-annular self-expanding valve platform in a nonagenarian patient with severe comorbidities and such a remarkable history of multiple previous interventions in the selected access site. Meticulous upfront strategy planning and efficient collaboration between specialties is of outmost importance in hybrid procedures for favorable clinical outcomes, especially in cases with challenging anatomies.

Device Closure of Aortic Paravalvular Leak

Significant paravalvular leak is a serious complication of surgical valve replacement. Approximately 1–5% of PVLs can lead to serious clinical consequences, including congestive heart failure and/or haemolytic anaemia. Surgical intervention was the standard care of treatment for this for years. We describe a case of aortic paravalvular leak, managed with transcatheter closure. Keywords Paravalvular leak, vascular plug, trans catheter closure

Aortic valve morphology and paravalvular leak regression after a self-expandable transcatheter aortic valve replacement.

Aims: The study aimed to compare paravalvular leak (PVL) changes after a transcatheter aortic valve replacement (TAVR) with self-expandable prosthesis between different aortic valve morphologies and evaluate the impact of paravalvular leak regression on clinical prognosis. Methods: Patients with aortic stenosis (AS) successfully treated with a self-expandable TAVR who were followed up for at least 1year at our centre were consecutively enrolled from January 2016 to August 2019. Paired serial changes in paravalvular leak and other haemodynamic parameters by echocardiography were collected and compared between the bicuspid valve (BAV) and tricuspid aortic valve (TAV). A logistic regression model was used to explore the predictors of paravalvular leak regression (<1 grade) 1year after transcatheter aortic valve replacement, while its impact on subsequent clinical outcomes (all-cause mortality and rehospitalisation for heart failure (HF)) was further evaluated using Kaplan-Meier analysis. Results: A total of 153 bicuspid valve and 114 tricuspid aortic valve patients were finally enrolled; haemodynamic parameters and paravalvular leak severity were comparable before the discharge between the two groups. The peak transaortic velocity, mean transvalvular gradient, and effective orifice area all significantly improved (p < 0.05) without intergroup differences at all follow-up timepoints. Significant paravalvular leak reduction was observed only in the TAV group (1.75% vs. 4.39%, p = 0.029), while moderate paravalular leak was still more prevalent in BAV (7.19% vs. 1.75%, p = 0.041) at the 1-year follow-up. Multivariable analyses identified the bicuspid valve, asymmetric calcification, and undersizing as independent predictors of failure of the 1-year paravalvular leak reduction in patients with mild or moderate paravalvular leak after discharge. Patients without a paravalvular leak reduction within 1 year showed a relatively higher 2-year all-cause mortality and HF (HR: 5.994, 95% CI: 1.691-21.240, and p = 0.053) rates thereafter. Conclusion: In AS patients after self-expandable transcatheter aortic valve replacement, paravalvular leak regression within 1year was less prevalent in bicuspid valve morphology. The failure of paravalvular leak reduction might lead to an increased risk of poorer prognosis in the long run.

3D printing from transesophageal echocardiography for planning mitral paravalvular leak closure - feasibility study.

Transcatheter closure of paravalvular leak (PVL) is still a demanding procedure due to the complex anatomy of PVL channels and risk of interference between the implanted occluder and surrounding structures. Efforts are made to improve procedural outcomes in transcatheter structural heart interventions by establishing treatment strategy in advance with the use of 3D-printed physical models based on data obtained from cardiac computed tomography (CT) studies. In this feasibility study 3D printing of PVL models based on data recorded during transesophageal echocardiography (TEE) examinations was evaluated. 3D-TEE data of patients with significant PVL around mitral valve prostheses were used to prepare 3D models. QLab software was used to export DICOM images in Cartesian DICOM format of each PVL with the surrounding tissue. Image segmentation was performed in Slicer, a free, open-source software package used for imaging research. Models were printed to actual size with the Polyjet printer with a transparent, rigid material. We measured dimensions of PVLs both in TEE recordings and printed 3D models. The results were correlated with sizes of occluding devices used to close the defects. In 7 out of 8 patients, there was concordance between procedurally implanted occluders and pre-procedurally matched closing devices based on 3D-printed models. 3D-printing from 3D-TEE is technically feasible. Both shape and location of PVLs are preserved during model preparation and printing. It remains to be tested whether 3D printing would improve outcomes of percutaneous PVL closure.

A Contrast Frugal Approach to Transcatheter Aortic Valve Replacement in Chronic Kidney Disease: A Pilot Study.

Transcatheter aortic valve replacement (TAVR) is now regarded as a viable treatment option for all cases of severe aortic stenosis (AS). Acute kidney injury (AKI) is common and lowers the survival of patients after TAVR and iodine-based contrast-induced nephropathy (CIN) plays a significant adverse role in AKI. Therefore, in chronic kidney disease (CKD) patients requiring pre-operative evaluation for TAVR, the risk of CIN is of particular concern. It was a single-center study including eight CKD patients who underwent pre-operative evaluation for TAVR with minimized contrast exposure by means of pre-operative contrast-sparing evaluation and intra-operative contrast minimization. All patients had glomerular filtration rate (eGFR) calculated before TAVR and on a follow-up about one month and one year post-operatively to document the impact of this TAVR protocol on prognosis of kidney function in patients with advanced CKD. New York Heart Association (NYHA) functional classification demonstrated significant improvement of symptomatology (p = 0.0001) by one-year post-TAVR. Patients' mean AS gradient was significantly improved (p = 0.00004) after the TAVR procedure. No significant post-operative paravalvular aortic regurgitation was noted on follow up echocardiogram. eGFR data showed mean eGFR for the group was slightly better (27.38 ml/min/per 1.73 m2 BSA vs. 30.38 ml/min/per 1.73 m2 BSA) after TAVR. "Contrast frugal" approach is feasible and safe for pre-TAVR evaluation and the procedure itself. Our pilot study showed no significant paravalvular leak of the prosthetic valve following this proposed protocol. No statistically significant decrease in eGFR was noted on a one-year follow-up.

TAVI With or Without Predilation: Trends From a Large, Propensity-Score Weighted German Aortic Valve Registry (GARY) Population.

Currently, it is unclear whether transcatheter aortic valve implantation (TAVI) without predilation (direct TAVI; d-TAVI) or with preimplantation balloon valvuloplasty (b-TAVI) provides similar clinical safety and efficacy. Therefore, we analyzed patients undergoing d-TAVI or b-TAVI for severe aortic stenosis (AS) with either self-expanding or balloon-expandable transcatheter heart valves (THVs) from the German Aortic Valve Registry (GARY). Between 2011 and 2017, a total of 44,783 TAVI patients were collected, with 25,717 (57.4%) receiving a balloon-expandable THV and 19,066 (42.6%) receiving a self-expanding THV. A propensity-score weighted model was used to compare d-TAVI vs b-TAVI regarding differences in outcome. B-TAVI was performed in 71% and d-TAVI was performed in 29% of patients. In the investigated time interval, frequency of b-TAVI declined from 88.4% to 58.2%, accompanied by a constant rate of postdilation. After propensity weighting of patients receiving balloon-expandable THV, d-TAVI vs b-TAVI was associated with more frequent postoperative transvalvular mean pressure gradients (mPG) >15 mm Hg (20.7% vs 18.4%; P<.001), similar rates of paravalvular leakage (PVL) ≥ moderate (18.0% vs 16.9%; P=.08), fewer postdilations (13.4% vs 15.5%; P<.001), and fewer complications (permanent pacemaker implantation, 10.2% vs 11.9% [P=.01]; vascular complications, 1.9% vs 2.6% [P<.01]; pericardial tamponade, 0.5% vs 0.9% [P<.01]; and stroke, 0.9% vs 1.3% [P=.02]). In patients receiving self-expanding THVs, d-TAVI vs b-TAVI was associated with more frequent postimplantation mean PG ≥ 15 mm Hg (12.7% vs 10.4%; P<.01), higher rates of PVL ≥ moderate (24.8% vs 16.5%; P<.001), and similar complication rates including permanent pacemaker implantation. The safety and efficacy of d-TAVI vs b-TAVI depends on the type of THV implanted. For balloon-expandable valves, d-TAVI provides an advantage, while self-expanding valves offer a similar safety profile for d-TAVI compared with b-TAVI. However, increased mPG post intervention with both valve types and more significant PVL in self-expanding THVs emphasize the importance of proper patient selection and evaluation of valve anatomy to identify suitable cases for d-TAVI.

Transcatheter Aortic Valve Implantation for Severe Bicuspid Aortic Stenosis - 2 Years Follow up Experience From India.

Transcatheter Aortic Valve Implantation for Severe Bicuspid Aortic Stenosis - 2 Years Follow up Experience From India.

Macroscopic and microscopic features of surgically explanted transcatheter aortic valve prostheses.

With the extended indications of transcatheter aortic valve (TAV) replacement (TAVR) to lower-risk patients, there is an increasing number of patients requiring surgical explantation of failed TAV. We sought to describe macroscopic and microscopic features of surgically explanted percutaneous aortic valve prostheses. Preoperative and surgical characteristic of patients undergoing surgical explantation of TAV were retrospectively analyzed from 2007 to 2020. Surgical and pathologic features of these valves, and outcomes of the surgical valve replacement were described. Out of 1764 patients who underwent a TAVR procedure, 21 were operated for TAV failure. Isolated or combined indications for surgery included: significant paravalvular leak (n = 15), delayed prosthesis migration (n = 5), significant increase of trans-TAV gradients (n = 6), and endocarditis (n = 3). Mean time elapsed between TAVR and explantations was 674.9 ± 803.9 days. Macroscopic lesions found on explanted percutaneous valves were severe adhesions to the aorta (n = 10), calcifications (n = 7), leaflet thrombosis (n = 4), and vegetations (n = 3). Except for patients with endocarditis, one or more pathological lesions were found in 15 patients. Pathology analyses on these valves showed fibro-calcific degenerations (n = 12), pannus formation (n = 9), and chronic inflammation (n = 3). One patient (4.8%) died after surgical explantation, and 13 (61.9%) had concomitant procedures. The survival rate at 1 year was 94.4%. Microscopic findings of fibro-calcific leaflet degeneration, and pannus formation in addition to macroscopic calcification and thrombosis present early, (within a mean of 2 years) after TAVR. Further investigation with a higher number of patients and echocardiographic follow-up is warranted.