Simplified balloon-BASILICA: A different perspective.

Nowadays, the long-life management of patients with aortic stenosis has emerged as one of the most debated issues. Transcatheter aortic valve replacement is more frequently performed in younger patients with lower surgical risk, and also the number of valve-in-valve (ViV) procedures has increased in the last few years. However, coronary obstruction is the most dreadful complication related to this procedure. To prevent coronary obstruction in the context of transcatheter aortic ViV implantation, the BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) technique was developed. Although effective, BASILICA is complex and time-consuming. Hence, simpler, reproducible, and faster strategies are desirable. Here we present a promising simplified BASILICA technique employing an Armada Balloon to perform the leaflet laceration.

Eligibility to COAPT trial in the daily practice: A real-world experience.

BACKGROUND: The COAPT Trial was the first ever to demonstrate a survival benefit in treating functional mitral regurgitation (FMR). That was achieved through transcatheter mitral repair in selected patients. The exact proportion of patients fulfilling COAPT selection criteria in the real-world is unknown. AIMS: To assess the applicability of COAPT criteria in real world and its impact on patients' survival. METHODS: We assessed the clinical data and follow-up results of all consecutive patients admitted for FMR at our Department between January 2016 and May 2021 according to COAPT eligibility. COAPT eligibility was retrospectively assessed by a cardiac surgeon and a cardiologist. RESULTS: Among 394 patients, 56 (14%) were COAPT eligible. The most frequent reasons for exclusion were MR ≤ 2 (22%), LVEF < 20% or >50% (19%), and non-optimized GDMT (21.3%). Among Non-COAPT patients, weighted 4-year survival was higher in patients who received MitraClip compared to those who were left in optimized medical therapy (91.5% confidence interval [CI: 0.864, 0.96] vs. 71.8% [CI: 0.509, 0.926], respectively, p = 0.027). CONCLUSIONS: Only a minority (14%) of real-world patients with FMR referred to a tertiary hospital fulfilled the COAPT selection criteria. Among Non-COAPT patients, weighted 4-year survival was higher in patients who received MitraClip compared to those who were left in optimized medical therapy (91.5% [0.864, 0.96] vs. 71.8% [0.509, 0.926], respectively, p = 0.027).

Remote proctoring during structural heart procedures: Toward a widespread diffusion of knowledge using mixed reality.

BACKGROUND: Despite its wide diffusion in surgical procedures, very few experiences are reported so far about the possible applications of remote proctoring (RP) in structural heart interventions. AIMS: Our aim was to demonstrate the feasibility, safety, and efficacy of RP during transcatheter edge-to-edge repair using a mixed reality-based head-mounted display (HMD). METHODS: Two users (a doctor and a proctor), wearing HMDs, were connected through a 5G network, allowing them to share audio and video signals. During the procedure, the proctor was located in a contiguous room, without any direct connection with the operator. The primary endpoint was noninferiority of HMD-mediated interaction if compared with direct in-person interaction. It was assessed using an operator-proctor interaction test based on six questions asked by the doctor to the proctor on six key procedural steps. RESULTS: Between September 2021 and April 2022, nine patients were enrolled in the study (15 clips delivered). The primary endpoint was reached in 9/15 clips implanted (60%). The first three failures were due to a chat software problem, and the others were linked with a 5G network malfunction. However, the HMD and its mixed reality tools were well tolerated by the operators, and no interference with the procedure was registered in any of the cases. CONCLUSIONS: In our experience, RP during structural heart interventions is feasible and efficacious. Wearing the HMD is comfortable and does not affect safety and effectiveness of interventional procedures. However, especially if considering a wide geographic use of this tool, a stable internet connection is imperative.

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

BACKGROUND: 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. AIMS: 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. METHODS: 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. RESULTS: 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%). CONCLUSION: In our study FEops HEARTguide™ simulations identified patients at risk for >trace PVL with ACURATE Neo2 TAVI but not for PPI.

Treatment of late paravalvular regurgitation after transcatheter aortic valve implantation: prognostic implications.

AIMS: Paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI) is associated with increased morbidity and mortality. The effect of transcatheter interventions to treat PVR after the index TAVI was investigated. METHODS AND RESULTS: A registry of consecutive patients who underwent transcatheter intervention for ≥ moderate PVR after the index TAVI at 22 centers. The principal outcomes were residual aortic regurgitation (AR) and mortality at 1 year after PVR treatment. A total of 201 patients were identified: 87 (43%) underwent redo-TAVI, 79 (39%) plug closure, and 35 (18%) balloon valvuloplasty. Median TAVI-to-re-intervention time was 207 (35; 765) days. The failed valve was self-expanding in 129 (63.9%) patients. The most frequent devices utilized were a Sapien 3 valve for redo-TAVI (55, 64%), an AVP II as plug (33, 42%), and a True balloon for valvuloplasty (20, 56%). At 30 days, AR ≥ moderate persisted in 33 (17.4%) patients: 8 (9.9%) after redo-TAVI, 18 (25.9%) after plug, and 7 (21.9%) after valvuloplasty (P = 0.036). Overall mortality was 10 (5.0%) at 30 days and 29 (14.4%) at 1 year: 0, 8 (10.1%), and 2 (5.7%) at 30 days (P = 0.010) and 11 (12.6%), 14 (17.7%), and 4 (11.4%) at 1 year (P = 0.418), after redo-TAVI, plug, and valvuloplasty, respectively. Regardless of treatment strategy, patients in whom AR was reduced to ≤ mild had lower mortality at 1 year compared with those with AR persisting ≥ moderate [11 (8.0%) vs. 6 (21.4%); P = 0.007]. CONCLUSION: This study describes the efficacy of transcatheter treatments for PVR after TAVI. Patients in whom PVR was successfully reduced had better prognosis. The selection of patients and the optimal PVR treatment modality require further investigation.

Post-infarct mitral insufficiency: when to resort to reparative surgery, when to the mitral clip.

Severe mitral insufficiency is a feared complication that develops in 10-12% of patients with myocardial infarction and ST elevation. It results from the rupture of the papillary muscle or is secondary to an acute remodelling of the left ventricle in its entirety or of the infarcted region. The mortality of patients with acute clinical onset reaches 50%. The ideal treatment of acute mitral insufficiency is controversial and still a source of debate. Most of these patients are at high surgical risk or inoperable; therefore, they are treated conservatively and have a poor prognosis. In these candidates, percutaneous treatment of insufficiency with percutaneous edge to edge can be considered an alternative.

Update on supra-annular sizing of transcatheter aortic valve prostheses in raphe-type bicuspid aortic valve disease according to the LIRA method.

Recent evidence has shown that transcatheter heart valve (THV) anchoring in bicuspid aortic valve (BAV) patients occurs at the level of the raphe, known as the LIRA (Level of Implantation at the RAphe) plane. Our previous work in a cohort of 20 patients has shown that the delineation of the perimeter and device sizing at this level is associated with optimal procedural outcome. The goals of this study were to confirm the feasibility of this method, evaluate 30-day outcomes of LIRA sizing in a larger cohort of patients, assess interobserver variation and reproducibility of this sizing methodology, and analyse the interaction of LIRA-sized prostheses with the surrounding anatomy. The LIRA sizing method was applied to consecutive patients presenting to our centre with raphe-type BAV disease between November 2018 and October 2021. Supra-annular self-expanding THVs were sized based on baseline CT scan perimeters at the LIRA plane and the virtual basal ring. In cases where there was discrepancy between the two measurements, the plane with the smallest perimeter was considered the reference for prosthesis sizing. Post-procedural device success, defined according to Valve Academic Research Consortium-2 (VARC-2) criteria, was evaluated in the overall cohort. A total of 50 patients (mean age 80 ± 6 years, 70% male) with raphe-type BAV disease underwent transcatheter aortic valve replacement (TAVR) using different THV prostheses. The LIRA plane method appeared to be highly successful (100% VARC-2 device success) with no procedural mortality, no valve migration, no moderate-severe paravalvular leak, and low transprosthetic gradients (residual mean gradient 8.2 ± 3.4 mmHg). There were no strokes, no in-hospital or 30-day mortality, and an incidence of in-hospital pacemaker implantation of 10%. Furthermore, measurement of the LIRA plane perimeter was highly reproducible between observers (r = 0.980; P < 0.001) and predictive of the post-procedural prosthetic valve perimeter on CT scanning (r = 0.981; P < 0.001). We confirm the feasibility of supra-annular sizing using the LIRA method in a large cohort of patients with high procedural success and good clinical outcomes at 30 days. Application of the LIRA method optimizes THV prosthesis sizing in patients with raphe-type BAV disease.

Self-expanding transcatheter aortic valve infolding: Current evidence, diagnosis, and management.

BACKGROUND: Prosthetic valve infolding is a rare but severe complication of transcatheter aortic valve implantation (TAVI) with self-expanding valves. However, currently available clinical data are limited and fragmented. OBJECTIVES: This report aims to provide a comprehensive overview of this complication focusing on predisposing factors, clinical presentation, diagnostic findings, treatment and clinical outcomes. METHODS: A systematic review of the literature was performed to identify cases of infolding occurring during TAVI with self-expanding valves published until August 2020. These data were pooled with all the retrospectively identified infolding cases occurred at San Raffaele Scientific Institute between December 2014 and August 2020. RESULTS: A total of 34 cases were included. Among patients with available data, 38% received a first-generation CoreValve, and 62% a second-generation Evolut R (82%) or Evolut PRO (18%). Infolding occurred mostly with ≥29-mm valves (94%). Predisposing factors included resheathing of a second-generation valve (82%), heavy calcification of the native valve (65%), lack of predilatation (16%), Sievers type-1 bicuspid aortic valve (11%), and improper valve loading (5%). Infolding resulted in severe PVL causing hemodynamic instability (29%) or cardiac arrest (12%). Postdilatation was the treatment strategy in 68%, while prosthesis replacement with a new device in 23% of cases. Device success rate was 82%. Death and stroke occurred in 3% and 12% of cases. CONCLUSIONS: Prosthetic valve infolding is typically observed after resheathing of a large-size self-expanding TAVI. When infolding is timely diagnosed, prosthesis removal and replacement should be pursued. Further studies are required to precisely define predisposing factors to prevent this complication.

The effect of transcatheter aortic valve implantation approaches on mortality.

OBJECTIVES: We aimed to evaluate the effect of transcatheter aortic valve implantation (TAVI) approaches on mortality and identify effect modifiers and predictors for mortality. BACKGROUND: Alternative access routes to transfemoral (TF) TAVI include the surgical intra-thoracic direct-aortic (DA) and transapical (TA) approach. TA TAVI has been associated with a higher mortality rate. We hypothesized that this is related to effect modifiers, in particular the left ventricular ejection fraction (LVEF). METHODS: This multicentre study derived its data from prospective registries. To adjust for confounders, we used propensity-score based, stabilized inverse probability weighted Cox regression models. RESULTS: In total, 5,910 patients underwent TAVI via TF (N = 4,072), DA (N = 524), and TA (N = 1,314) access. Compared to TF, 30-day mortality was increased among DA (HR 1.87, 95%CI 1.26-2.78, p = .002) and TA (HR 3.34, 95%CI 2.28-4.89, p < .001) cases. Compared to TF, 5-year mortality was increased among TA cases (HR 1.50, 95%CI 1.24-1.83, p < .001). None of the variables showed a significant interaction between the approaches and mortality. An impaired LVEF (≤35%) increased mortality in all approaches. CONCLUSIONS: The surgical intra-thoracic TA and DA TAVI are both associated with a higher 30-day mortality than TF TAVI. TA TAVI is associated with a higher 5-year mortality than TF TAVI. The DA approach may therefore have some advantages over the TA approach when TF access is not feasible.

Aortic and mitral bioprosthetic valve dysfunction: surgical or percutaneous solutions?

In the last years, there has been a trend to prefer biological prostheses, especially among young patients, with the aim to avoid anticoagulant treatment. Surgical tissue valves have so far demonstrated their solid long-term durability. However, younger age has been identified as one of the main risk factors for developing structural valve deterioration (SVD). As a consequence, the proportion of subjects at risk for valve dysfunction will constantly rise in the near future. However, while surgical reintervention has always been considered the gold standard for treatment of prosthesis deterioration, the introduction of transcatheter heart valves could offer new therapeutical options, particularly among high-risk patients, aiming a second less invasive chance. The recent standardization of valve durability definitions will soon allow a more comprehensive understanding of the mechanism underlying SVD and guide the choice of prosthesis for patients needing valve replacement.

First-in-man Valve-in-Valve with the new balloon-expandable Myval transcatheter heart valve in a failed sutureless Perceval bioprosthesis.

Sutureless aortic bioprostheses were introduced more than ten years ago, with the aim of decreasing cross-clamp time and thus becoming the first choice in older patients for many surgeons. However, published data are limited to a 5-year follow-up, and some cases of deterioration have already been described. High-risk patients who once have benefitted from a fast sutureless aortic replacement and now are experiencing a prosthesis dysfunction, could take advantage of a percutaneous Valve-in-Sutureless technique. Furthermore, thanks to technological improvement, new transcatheter prostheses have been designed, allowing a more precise positioning. In this report, we described the first Myval-in-Perceval case, which resulted in a safe and effective procedure.

Complicated postoperative course in isolated tricuspid valve surgery: Looking for predictors.

BACKGROUND: This study aims at better defining the profile of patients with a complicated versus noncomplicated postoperative course following isolated tricuspid valve (TV) surgery to identify predictors of a favorable/unfavorable hospital outcome. METHODS: All patients treated with isolated tricuspid surgery from March 1997 to January 2020 at our institution were retrospectively reviewed. Considering the complexity of most of these patients, a regular postoperative course was arbitrarily defined as a length-of-stay in intensive care unit less than 4 days and/or postoperative length-of-stay less than 10days. Patients were therefore divided accordingly in two groups. RESULTS: One hundred and seventy-two patients were considered, among whom 97 (56.3%) had a regular (REG) and 75 (43.6%) a non-regular (NEG) postoperative course. The latter had worse baseline clinical and echocardiographic characteristics, with higher rate of renal insufficiency, previous heart failure hospitalizations, cardiac operations, and right ventricular dysfunction. NEG patients more frequently needed tricuspid replacement and experienced a greater number of complications (p < .001) and higher in-hospital mortality (13% vs. 0%, p < .001). The majority of these complications were related to more advanced stage of the tricuspid disease. Among most important predictors of a negative outcome univariate analysis identified chronic kidney disease, ascites, previous right heart failure hospitalizations, right ventricular dysfunction, previous cardiac surgeries, TV replacement and higher MELD scores. At multivariate analysis, liver enzymes and diuretics' dose were predictors of complicated postoperative course. CONCLUSION: In isolated TV surgery a complicated postoperative course is observed in patients with more advanced right heart failure and organ damage. Earlier surgical referral is associated to excellent outcomes and should be recommended.

Comparing traditional aortic valve surgery and transapical approach to transcatheter aortic valve implant.

During the last 15 years, transcatheter aortic valve implant (TAVI) has become a valid alternative to surgical aortic valve replacement in symptomatic patients with severe aortic stenosis, and high or intermediate operative risk. Transcatheter aortic valve implant could be approached through various access sites, among which the transapical has long been one of the most popular. Through the years, this procedure has shown results similar to the standard surgical approach, but not as good as the same procedure via the transfemoral approach. For this reason, along with continuous technological advances, the transfemoral approach is used, presently, in 90% of the patient, while the transapical route has been limited, progressively, to a minority of patients. Currently the Heart Team should decide, in every single patient, between conventional surgery and TAVI. In clinical practice, TAVI is favoured in high-risk patients, and in the elderly at intermediate surgical risk with favourable anatomical features. In patients in whom TAVI is preferable to surgery, but have 'non-usable' femoral approach, alternative routes, such as transaxillary or transapical, could be considered.

Severe aortic stenosis in the young, with or without bicuspid valve: is transcatheter aortic valve implantation the first choice?

During the last decade, transcatheter aortic valve implantation (TAVI) has represented a valid alternative to surgical aortic valve replacement in patients with aortic stenosis and elevated surgical risk. Recent randomized clinical trials reported excellent results also for patients at low surgical risk, but in clinical practice, the mean age of the patients treated remain over 75 years, and the presence of a bicuspid aortic valve still represents an important exclusion criteria. Today, aortic valve replacement with a mechanical prosthesis remains the treatment of choice for young adults with aortic stenosis, although the desire to avoid oral anticoagulants drives more patients younger than 65 years of age towards biological prostheses. Furthermore, despite the follow-up of patients after TAVI is still limited to a few years, the opportunity of a second percutaneous treatment (TAVI-in-TAVI), extends the scope of percutaneous strategy. In the next few years, TAVI has to face many challenges to become a valid alternative to surgery in the younger patients as well.

Self-expandable valve-in-valve treatment for failing sutureless aortic bioprosthesis.

Aortic valve replacement still represents the gold standard treatment for severe symptomatic aortic stenosis. Sutureless bioprostheses have been so far developed to enhance the minimally invasive approach, resulting in a reduction of cross-clamp time. Even if the first implantation was carried out more than 10 years ago, some cases of valve degeneration treated with balloon-expandable valve-in-valve procedures have been previously described in the literature. Here, we present a case of early sutureless valve degeneration resulting in severe aortic regurgitation. After careful evaluation of the patient's comorbidities, a successful valve-in-valve was finally performed using a self-expandable transcatheter prosthesis. A wide discussion of the Heart Team decision-making process and of the technical aspects has been addressed.

Mid-term outcomes (up to 5 years) of percutaneous edge-to-edge mitral repair in the real-world according to regurgitation mechanism: A single-center experience.

OBJECTIVES: To report mid-term results after MitraClip repair, according to mitral regurgitation (MR) mechanism, in a real-world single-center experience. BACKGROUND: Mid-term outcomes of percutaneous edge-to-edge mitral repair in the real world are still limited. METHODS: We assessed the follow-up results of patients treated with MitraClip at a single high-volume mitral center from 2008 to 2016. All patients underwent Heart-Team discussion, prospective data collection and enrolment in a dedicated outpatient clinic. Functional (FMR, n = 242, 68.6%) and degenerative (DMR, n = 97, 27.5%) MR patients were separately analyzed. RESULTS: 5-Year survival was 53.5 ± 4.5% in FMR vs 57.1 ± 7.5% in DMR (P = 0.087). Reduced survival was strongly associated with worse left ventricle remodeling (ESV HR 1.01, CI 1.01-1.02, P < 0.001) in FMR, and with worse symptoms (New York Heart Association IV HR 6.72, CI 1.78-25.45, P = 0.005) in DMR. 5-Year cumulative incidence function for MR ≥ 3 was 23.7 ± 3.4% in FMR vs 27.9 ± 5.9% in DMR (P = 0.39), being associated with residual MR = 2 both in FMR (HR 4.67, CI 2.49-8.74, P < 0.001) and DMR (HR 7.15, CI 2.72-18.75, P < 0.001). At 5-year, patients in NYHA class I-II increased from 17.9% to 45.3% in FMR (P < 0.001) and from 33.3% to 51.3% in DMR (P < 0.001). CONCLUSIONS: In this single-center real-world experience, 5-year after MitraClip, half of the patients were alive and 3/4 were free from MR, both in FMR and DMR. Symptoms benefit was sustained in both groups. Advanced ventricular remodeling, advanced symptoms, and suboptimal MR reduction were associated with worse results. Refined patient selection, improved efficacy and more data will be all required to improve long-term outcomes.

Anatomic and procedural associations of transcatheter heart valve displacement following Evolut R implantation.

OBJECTIVES: This study aimed to predict the displacement of self-expanding transcatheter heart valves (THV) during final deployment. BACKGROUND: Accurate device positioning during transcatheter aortic valve implantation (TAVI) is crucial for optimal results. METHODS: At our institution, 103 patients who underwent transfemoral TAVI with Evolut R were retrospectively identified. Multiple linear regression models were created, and a predictor equation was built to quantify the factors that may affect THV behavior. RESULTS: Multiple linear regression analysis for THV displacement on the left coronary cusp (LCC) identified the angle between the THV and the ascending aorta (ATA), predilation, and less operator experience as independent predictors of upward displacement, whereas estimated glomerular filtration rate (eGFR) was inversely related with THV behavior (95% confidence interval: 0.219 to 0.340, 0.447 to 2.092, 0.165 to 1.757, and -0.053 to -0.011, respectively). Predictors of THV displacement on the noncoronary cusp side could not be identified using this model. CONCLUSIONS: The ATA at the point of recapture, predilation, and less operator experience were independent predictors of upward displacement of THV on the LCC side. eGFR was an independent predictor of THV downward displacement on the LCC side. Of them, the ATA was the strongest predictor. Physicians may need to adjust this angle adequately before deployment to achieve the appropriate position.

Anesthesiologic Management of Patients Undergoing Cardiac Transapical Procedures: Which Challenges in the Modern Era?

OBJECTIVE: Patients undergoing transapical cardiac procedure are a minority of cardiac surgery patients but represent a challenge for cardiac anesthesiologists because they generally are older and have more comorbidities than do open heart cardiac surgery patients. The aims of this study were to describe the anesthetic experience with transapical procedures in a single high-volume center and to analyze the most critical aspects for anesthetic management. DESIGN: Retrospective study. SETTING: IRCCS San Raffaele Scientific Institute, Milan, Italy. PARTICIPANTS: All patients undergoing a cardiac transapical procedure from January 2009 to April 2018 were included in this case series. INTERVENTIONS: Patients were managed by a multidisciplinary heart team. The perioperative anesthetic approach and hemodynamic management were consistent and performed by a group of trained cardiac anesthesiologists. MEASUREMENTS AND MAIN RESULTS: The study population comprised 143 patients: 81 (57%) underwent an aortic valve procedure, 60 (42%) a mitral valve intervention, 1 patient underwent a procedure involving both the aortic and mitral valves, and 1 patient underwent correction of a congenital heart defect. A major intraoperative complication occurred in 5 (3.5%) patients, the procedure was not technically feasible because of unsuitable anatomy in 3 patients, and conversion to open heart surgery was needed in 2 patients. All patients were admitted to the intensive care unit. Intensive care unit stay was 1 (1-3) days, and hospital stay was 6 (5-8) days. Hospital survival was 94%. CONCLUSIONS: Patients undergoing transapical cardiac procedures are a minority of cardiac surgery patients, but represent a high-risk population. A patient-tailored anesthetic approach, in the context of the therapeutic strategy shared by the heart team, is crucial to improve outcomes.

A comparison of the fully repositionable and retrievable Boston Lotus and direct flow medical valves for the treatment of severe aortic stenosis: A single center experience.

BACKGROUND: Second generation transcatheter aortic valve implantation (TAVI) devices have been designed to reduce the rate of paravalvular leak (PVL) and other complications. An important technological advancement has been the ability to fully reposition devices to facilitate optimal implantation depth and position to reduce the likelihood of PVL. OBJECTIVES: To compare procedural and 30-day outcomes according to the Valve Academic Research Consortium (VARC)-2 criteria following TAVI with the fully repositionable and retrievable Lotus and DFM devices. METHODS AND RESULTS: 175 patients with severe aortic stenosis underwent transfemoral TAVI with the Lotus (n = 60) and DFM (n = 115) valve. Baseline clinical characteristics did not differ between the two groups. All devices were successfully implanted, with one case of valve embolization in the Lotus group. Device success (95 vs. 98.2%, P = 0.89), VARC-defined combined safety (90 vs. 93%, P = 0.48), and clinical efficacy (86.7 vs. 90.4%, P = 0.65) rates at 30-days were similar between Lotus and DFM groups. There was no severe PVL; one patient in both Lotus and DFM group developed moderate PVL after the procedure. The Lotus valve was associated with a higher rate of new pacemaker implantation (37.3 vs. 11.2%, P < 0.001) and a lower mean aortic gradient (9.4 ± 5 vs. 12.3 ± 5, P < 0.001) at 30-days as compared with the DFM valve. CONCLUSIONS: In this single-center, retrospective analysis, both Lotus and DFM devices demonstrated excellent device success, safety and efficacy at 30-day follow-up. The DFM valve was associated with minimally higher transvalvular gradients but lower new pacemaker implantation rates when compared to the Lotus valve.