Off-Label Use of Balloon-Expandable Transcatheter Valves to Treat Pure Aortic Regurgitation.

Transcatheter aortic valve implantation (TAVI) in native pure aortic regurgitation (AR) with off-label use of balloon-expandable valves (BEV) has been reported. However, there are scant data regarding optimal oversizing and its safety, and our study assessed BEV oversizing and outcomes of TAVI. Thirteen consecutive tricuspid aortic valve patients who underwent transfemoral TAVIs for pure AR with Sapien BEV at our center between 2019 and 2023 (69.2% males, mean age 80.8 years, Society of Thoracic Surgeons 4.0%) were divided into small annulus (SA) group (≤618 mm2) where ≥20% oversizing is achievable based on published data on BEV overexpansion, and larger annulus (LA) group (>618 mm2). Overexpansion and actual oversizing were measured on postprocedural computed tomography scan. Technical success was 92.3% with 1 valve embolization in the LA group. The postprocedural computed tomography showed a mean 28.3% oversizing, significantly higher in SA (31.2%) than in LA group (19.4%), p = 0.0092. Oversizing ≥20% was achieved in 100% SA versus 33.3% LA patients (p = 0.046). In conclusion, TAVI in pure AR with oversized Sapien BEV showed good procedural and short-term outcomes when ≥20% oversizing was predictably achievable.

The role of the vascular surgeon in transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become the standard treatment for severe aortic valve stenosis in patients at increased surgical risk. Percutaneous transfemoral (TF) is the access of choice due to its reduced invasiveness and perioperative morbidity/mortality compared with the trans-axillary, aortic, and apical routes. On the other hand, vascular access complications (VACs) of the TF access are associated with prolonged hospitalization, 30-day, and 1-year mortality. In addition, the concomitance of peripheral arterial disease may require associated endovascular management. A multidisciplinary team with Interventional Cardiologists and Vascular Surgeons may minimize the rate of VACs in patients with challenging femoral-iliac access or concomitant disease of other vascular districts, thus optimizing the outcome of TF-TAVI. The aim of this study was to evaluate the role of Vascular Surgeons in TF TAVI procedures. METHODS: We conducted a retrospective single-center review of all TF-TAVI procedures assisted by Vascular Surgeons between January 2016 and December 2020 in a high-volume tertiary hospital. Pre, intra, and postoperative data were analyzed by a dedicated group of Interventional Cardiologists and Vascular Surgeons. VACs were defined according with the Valve Academic Research Consortium (VARC) three guidelines. The outcomes of TF-TAVI procedures with Vascular Surgeons involvement were assessed as study's endpoints. RESULTS: Overall, 937 TAVI procedures were performed with a TF approach ranging between 78% (2016) and 98% (2020). Vascular Surgeons were involved in 67 (7%) procedures with the following indications: concomitant abdominal aortic aneurysm (EVAR + TAVI) - 3 (4%), carotid stenosis (TAVI + CAS) - 2 (3%), hostile femoral/iliac access, or VACs - 62 (93%). Balloon angioplasty of iliac artery pre-TAVI implantation was performed in 51 cases (conventional PTA: 38/51%-75%; conventional PTA + intravascular lithotripsy: 13/51%-25%; stenting: 5/51%-10%). TAVI procedure was successfully completed by percutaneous TF approach in all 62 cases with challenging femoral/iliac access. VACs necessitating interventions were 18/937 (2%) cases, localized to the common femoral or common/external iliac artery in 15/18 (83%) and 3/18 (17%) cases, respectively. They were managed by surgical or endovascular maneuvers in 3/18 (17%) and 15/18 (83%) cases, respectively. Fifteen/18 (83%) VACs were treated during the index procedure. There was no procedure-related mortality or 30-day readmission. CONCLUSION: In our experience, Vascular Surgeon assistance in TAVI procedures was not infrequent and allowed safe and effective device introduction through challenging TF access. Similarly, the concomitant significant disease of other vascular districts could be safely addressed, potentially reducing postoperative related mortality and morbidity. The implementation of multidisciplinary team with interventional cardiologists and vascular surgeons should be encouraged whenever possible.

A novel high-risk aortic root anatomy for right coronary artery occlusion during TAVI.

Acute coronary occlusion during transcatheter aortic valve implantation (TAVI) is a rare but potentially lethal complication. Main mechanisms are sinus insufficiency or sinus sequestration with well-described risk factors. We present two cases of acute right coronary artery occlusion during TAVI with a self-expanding valve in the absence of classical risk factors and propose a novel mechanism.

Comparison of different percutaneous revascularisation timing strategies in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: The optimal timing to perform percutaneous coronary interventions (PCI) in transcatheter aortic valve implantation (TAVI) patients remains unknown. AIMS: We sought to compare different PCI timing strategies in TAVI patients. METHODS: The REVASC-TAVI registry is an international registry including patients undergoing TAVI with significant, stable coronary artery disease (CAD) at preprocedural workup. In this analysis, patients scheduled to undergo PCI before, after or concomitantly with TAVI were included. The main endpoints were all-cause death and a composite of all-cause death, stroke, myocardial infarction (MI) or rehospitalisation for congestive heart failure (CHF) at 2 years. Outcomes were adjusted using the inverse probability treatment weighting (IPTW) method. RESULTS: A total of 1,603 patients were included. PCI was performed before, after or concomitantly with TAVI in 65.6% (n=1,052), 9.8% (n=157) or 24.6% (n=394), respectively. At 2 years, all-cause death was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (6.8% vs 20.1% vs 20.6%; p<0.001). Likewise, the composite endpoint was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (17.4% vs 30.4% vs 30.0%; p=0.003). Results were confirmed at landmark analyses considering events from 0 to 30 days and from 31 to 720 days. CONCLUSIONS: In patients with severe aortic stenosis and stable coronary artery disease scheduled for TAVI, performance of PCI after TAVI seems to be associated with improved 2-year clinical outcomes compared with other revascularisation timing strategies. These results need to be confirmed in randomised clinical trials.

Predictors of bail-out stenting in patients with small vessel disease treated with drug-coated balloon percutaneous coronary intervention.

BACKGROUND: Drug-coated balloons (DCBs) have shown comparable results with drug-eluting stents in small vessel disease (SVD) percutaneous coronary intervention (PCI) in terms of target vessel revascularization and a reduced incidence of myocardial infarction. However, the relatively high rate of bail-out stenting (BOS) still represents a major drawback of DCB PCI. AIMS: The aim of the study was to investigate the clinical, anatomic, and procedural features predictive of BOS after DCB PCI in SVD. METHODS: We included all consecutive patients undergoing PCI at our institution between January 2020 and May 2022 who were treated with DCB PCI of a de novo lesion in a coronary vessel with a reference vessel diameter (RVD) between 2.0 and 2.5 mm. Angiographic success was defined as a residual stenosis <30% without flow-limiting dissection. Patients who did not meet these criteria underwent BOS. RESULTS: A total of 168 consecutive patients and 216 coronary stenoses were included. The rate of bail-out stent was 13.9%. On multivariate analysis, DCB/RVD ratio (odds ratio [OR]: 4.39, 95% confidence interval [CI]: 1.71-11.29, p < 0.01), vessel tortuosity (OR: 7.00, 95% CI: 1.66-29.62, p < 0.01), distal vessel disease (OR: 5.66, 95% CI: 2.02-15.83, p < 0.01), and high complexity (Grade C of ACC/AHA classification) coronary stenoses (OR: 6.31, 95% CI: 1.53-26.04, p = 0.01) were independent predictors of BOS. CONCLUSIONS: BOS is not an infrequent occurrence in DCB PCI of small vessels and is correlated with vessel tortuosity, distal diffuse vessel disease, higher lesion complexity, and balloon diameter oversizing.

Vascular Access in Patients With Peripheral Arterial Disease Undergoing TAVR: The Hostile Registry.

BACKGROUND: The optimal access route in patients with severe peripheral artery disease (PAD) undergoing transcatheter aortic valve replacement (TAVR) remains undetermined. OBJECTIVES: This study sought to compare clinical outcomes with transfemoral access (TFA), transthoracic access (TTA), and nonthoracic transalternative access (TAA) in TAVR patients with severe PAD. METHODS: Patients with PAD and hostile femoral access (TFA impossible, or possible only after percutaneous treatment) undergoing TAVR at 28 international centers were included in this registry. The primary endpoint was the propensity-adjusted risk of 30-day major adverse events (MAE) defined as the composite of all-cause mortality, stroke/transient ischemic attack (TIA), or main access site-related Valve Academic Research Consortium 3 major vascular complications. Outcomes were also stratified according to the severity of PAD using a novel risk score (Hostile score). RESULTS: Among the 1,707 patients included in the registry, 518 (30.3%) underwent TAVR with TFA after percutaneous treatment, 642 (37.6%) with TTA, and 547 (32.0%) with TAA (mostly transaxillary). Compared with TTA, both TFA (adjusted HR: 0.58; 95% CI: 0.45-0.75) and TAA (adjusted HR: 0.60; 95% CI: 0.47-0.78) were associated with lower 30-day rates of MAE, driven by fewer access site-related complications. Composite risks at 1 year were also lower with TFA and TAA compared with TTA. TFA compared with TAA was associated with lower 1-year risk of stroke/TIA (adjusted HR: 0.49; 95% CI: 0.24-0.98), a finding confined to patients with low Hostile scores (Pinteraction = 0.049). CONCLUSIONS: Among patients with PAD undergoing TAVR, both TFA and TAA were associated with lower 30-day and 1-year rates of MAE compared with TTA, but 1-year stroke/TIA rates were higher with TAA compared with TFA.

One-year outcomes after transcatheter aortic valve implantation with the latest-generation SAPIEN balloon-expandable valve: the S3U registry.

BACKGROUND: Initial data about the performance of the new-generation SAPIEN 3 Ultra (S3U) valve are highly promising. However, evidence about the longer-term performance and safety of the S3U is scarce. AIMS: We aimed to investigate the 1-year clinical and echocardiographic outcomes of transcatheter aortic valve implantation (TAVI) using the S3U compared with its predecessor, the SAPIEN 3 valve (S3). METHODS: The SAPIEN 3 Ultra registry included consecutive patients who underwent transfemoral TAVI at 12 European centres with the S3U or S3 between October 2016 and December 2020. One-to-one propensity score (PS) matching was performed to account for differences in baseline characteristics. The primary outcomes of interest were all-cause death and the composite of all-cause death, disabling stroke and hospitalisation for heart failure at 1 year. RESULTS: The overall study cohort encompassed 1,692 patients treated with either the S3U (n=519) or S3 (n=1,173). The PS-matched population had a total of 992 patients (496 per group). At 1 year, the rate of death from any cause was 4.9% in the S3U group and 6.3% in the S3 group (p=0.743). Similarly, there were no significant differences in the rates of the primary composite outcome (9.5% in the S3 group and 6.6% in the S3U group; p=0.162). The S3U was associated with lower rates of mild paravalvular leak (PVL) compared with the S3 (odds ratio 0.63, 95% confidence interval: 0.44 to 0.88; p<0.01). No significant differences in transprosthetic gradients were observed between the two groups. CONCLUSIONS: Compared with the S3, the S3U transcatheter heart valve was associated with similar 1-year clinical outcomes but reduced rates of mild PVL.

Coronary ectasia in different scenarios, primarily in myocardial infarction with nonobstructive coronary artery disease.

AIMS: Several causes have been reported for coronary artery ectasia (CAE), mostly atherosclerosis and tunica media abnormalities. The main aim of the present study was to investigate if CAE extension differs in distinct clinical settings. METHODS: Three hundred and forty-one patients with diagnosis of CAE were identified among 9659 coronary angiographies and divided into four groups according to the patient's admission diagnosis: stable or unstable angina (S-UA), myocardial infarction (MI), aortic disease, aortic valvular disease (AVD). S-UA and MI were subgrouped according to the presence of obstructive coronary artery disease (OCAD). Multivariable logistic regression was used to investigate the relationship between clinical diagnosis and CAE extension as expressed by Markis classification and number of coronary vessels affected by CAE. RESULTS: No significant differences in CAE extension were found among the four groups, in terms of vessels affected by CAE (P = 0.37) or Markis class (P = 0.33). CAE was not related to the extension of OCAD as assessed by the Gensini score, which was higher in MI and S-UA groups (P < 0.01). However, when ischemic patients were sub-divided on the basis of the presence of OCAD, MI without obstructive coronary artery disease (MINOCA) was associated with a higher extension of CAE in terms of Markis class 1 (OR 5.08, 95% CI 1.61-16.04; P < 0.01). CONCLUSION: The extension of CAE is comparable in patients referred to coronary angiography for different clinical scenarios, including S-UA, MI, aortic disease, and AVD; however, patients with MINOCA were associated with a higher extension of CAE.Graphical abstract: Difference in coronary artery ectasia extension in terms of Markis class severity, respectively, stratified by clinical presentation and obstructive coronary artery disease presence, http://links.lww.com/JCM/A519.

Management of Myocardial Revascularization in Patients With Stable Coronary Artery Disease Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: The best management of stable coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI) is still unclear due to the marked inconsistency of the available evidence. METHODS: The REVASC-TAVI registry (Management of Myocardial Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation With Coronary Artery Disease) collected data from 30 centers worldwide on patients undergoing TAVI who had significant, stable CAD at preprocedural work-up. For the purposes of this analysis, patients with either complete or incomplete myocardial revascularization were compared in a propensity score matched analysis, to take into account of baseline confounders. The primary and co-primary outcomes were all-cause death and the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure, respectively, at 2 years. RESULTS: Among 2407 patients enrolled, 675 pairs of patients achieving complete or incomplete myocardial revascularization were matched. The primary (21.6% versus 18.2%, hazard ratio' 0.88 [95% CI, 0.66-1.18]; P=0.38) and co-primary composite (29.0% versus 27.1%, hazard ratio' 0.97 [95% CI, 0.76-1.24]; P=0.83) outcome did not differ between patients achieving complete or incomplete myocardial revascularization, respectively. These results were consistent across different prespecified subgroups of patients (< or >75 years of age, Society of Thoracic Surgeons score > or <4%, angina at baseline, diabetes, left ventricular ejection fraction > or <40%, New York Heart Association class I/II or III/IV, renal failure, proximal CAD, multivessel CAD, and left main/proximal anterior descending artery CAD; all P values for interaction >0.10). CONCLUSIONS: The present analysis of the REVASC-TAVI registry showed that, among TAVI patients with significant stable CAD found during the TAVI work-up, completeness of myocardial revascularization achieved either staged or concomitantly with TAVI was similar to a strategy of incomplete revascularization in reducing the risk of all cause death, as well as the risk of death, stroke, myocardial infarction, and rehospitalization for heart failure at 2 years, regardless of the clinical and anatomical situations.

Overinflation of balloon-expandable valves for transcatheter treatment of pure noncalcified native aortic regurgitation: How much oversizing is needed and achievable?

Transcatheter aortic valve implantation (TAVI) in noncalcified pure aortic valve regurgitation is challenging as dedicated valves are not widely available. We present a case series of four inoperable patients who underwent compassionate TAVI for this indication at our institution with a balloon-expandable valve. In this context, we analyzed the relevant technical aspects such as the need for larger oversizing of the transcatheter prosthesis and the safety and limits of valve overexpansion.

Reduced Mortality With Antiplatelet Therapy Deescalation After Percutaneous Coronary Intervention in Acute Coronary Syndromes: A Meta-Analysis.

BACKGROUND: Antiplatelet therapy deescalation has been suggested as an alternative to standard treatment with potent dual antiplatelet therapy (DAPT) for 1 year in low bleeding risk patients with acute coronary syndromes undergoing percutaneous coronary intervention to mitigate the increased risk of bleeding. Whether this strategy preserves the ischemic and survival benefits of potent DAPT is uncertain. METHODS: We performed a pairwise meta-analysis in patients with acute coronary syndrome undergoing percutaneous coronary intervention treated with either 1-year standard potent DAPT versus deescalation therapy (potent DAPT for 1-3 months followed by either reduced potency DAPT or ticagrelor monotherapy for up to 1 year). Randomized trials comparing standard DAPT versus deescalation therapy in patients with acute coronary syndrome undergoing percutaneous coronary intervention were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. The primary end point was 1-year all-cause mortality. RESULTS: The meta-analysis included 6 trials in which 20 837 patients were randomized to potent DAPT for 1 to 3 months followed by deescalation therapy for up to 1 year (n=10 392) or standard potent DAPT for 1 year (n=10 445). Deescalation therapy was associated with lower 1-year rates of all-cause mortality compared with standard therapy (odds ratio, 0.75 [95% CI, 0.59-0.95]; P=0.02). Deescalation therapy was also associated with lower rates of major bleeding (odds ratio, 0.59 [95% CI, 0.48-0.72]; P<0.0001), with no significant difference in major adverse cardiac events (major adverse cardiovascular events; odds ratio, 0.89 [95% CI, 0.77-1.04]; P=0.14). CONCLUSIONS: In low bleeding risk patients with acute coronary syndrome undergoing percutaneous coronary intervention, compared with 1-year of potent DAPT, antiplatelet therapy deescalation therapy after 1 to 3 months was associated with decreased mortality and major bleeding with similar rates of major adverse cardiovascular events.

Gender-related differences in changes of estimated bleeding risk in patients on dual antiplatelet therapy: the RE-SCORE multicenter prospective registry.

The risk of bleeding as predicted by the PRECISE-DAPT score can vary over time after percutaneous coronary intervention (PCI). We sought to compare the predictive ability of the PRECISE-DAPT score calculated at baseline and reassessed during follow-up in male and female patients undergoing PCI. The RE-SCORE was a multicenter, prospective registry including patients undergoing PCI treated with dual antiplatelet therapy (DAPT) for 1 year. The primary endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding. The PRECISE-DAPT score was determined for each patient at the time of PCI and at 1, 4 and 8-month follow-up visits or before the occurrence of an endpoint event. A total of 480 patients undergoing PCI were included. At baseline, median PRECISE-DAPT score was similar in males (23.2 [IQR 20.1-24.2]) and females (23.4 [IQR 20.2-25.3]; p = .22). During follow-up, an increase in the PRECISE-DAPT occurred significantly more often in females (44%) than in males (23%; p < .001). The discrimination of the PRECISE-DAPT score calculated at baseline was marginal in both males (c-index = 0.59, 95% CI: 0.51-0.65) and females (c-index = 0.55, 95% CI: 0.49-0.60). The discriminative ability of the score reassessed at follow-up was excellent in females (c-index = 0.84; 95% CI: 0.77-0.91) but remained modest in males (c-index = 0.61; 95% CI: 0.55-0.70). The bleeding predictive ability of the PRECISE-DAPT score can vary over time, more commonly in females than males. The discrimination of the score calculated during follow-up appeared improved in females but remained modest in males.Clinical Trial Registration - ClinicalTrials.gov Identifier: NCT03526614.

Iliac "paving & cracking" technique for transcatheter aortic valve implantation.

Challenging femoral/iliac access (CA) can lead to vascular complications which can hamper the clinical benefit of transfemoral (TF) transcatheter aortic valve implantation (TAVI). In this sense, iliac artery rupture is a severe complication associated with significant morbidity and mortality. We report a case of TF-TAVI managed with the "paving and cracking technique" to overcome CA.

Female gender and mortality in ST-segment-elevation myocardial infarction treated with primary PCI.

AIMS: To investigate gender difference in mortality among patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous angioplasty (PPCI). METHODS: We analyzed data from the prospective registries of two hub PPCI centres over a 10-year period to assess the role of female gender as an independent predictor of both all-cause and cardiac death at 30 days and 1 year. To account for all confounding variables, a propensity score (PS)-adjusted multivariable Cox regression model and a PS-matched comparison between the male and female were used. RESULTS: Among 4370 consecutive STEMI patients treated with PPCI at participating centres, 1188 (27.2%) were women. The survival rate at 30 days and 1 year were significantly lower in women (Log-rank P-value < 0.001). At PS-adjusted multivariable Cox regression analysis, female gender was independently associated with an increased risk of 30-day all-cause death [hazard ratio (HR) = 2.09; 95% confidence interval (CI): 1.45-3.01, P < 0.001], 30-day cardiac death (HR = 2.03;95% CI:1.41-2.93, P < 0.001), 1-year all-cause death (HR = 1.45; 95% CI:1.16-1.82, P < 0.001) and 1-year cardiac death (HR = 1.51; 95% CI:1.15-1.97, P < 0.001). For the study outcome, we found a significant interaction of gender with the multivessel disease in females who were at increased risk of mortality in comparison with men in absence of multivessel disease. After the PS matching procedure, a subset of 2074 patients were identified. Women still had a lower survival rate and survival free from cardiac death rate both at 30-day and at 1-year follow-up. CONCLUSION: As compared with men, women with STEMI treated with PPCI have higher risk of both all-cause death and cardiac mortality at 30-day and 1-year follow-up.

Pattern of arterial inflammation and inflammatory markers in people living with HIV compared with uninfected people.

STUDY DESIGN: To compare arterial inflammation (AI) between people living with HIV (PLWH) and uninfected people as assessed by 18F-Fluorodeoxyglucose (18F-FDG)-positron emission tomography (PET). METHODS: We prospectively enrolled 20 PLWH and 20 uninfected people with no known cardiovascular disease and at least 3 traditional cardiovascular risk factors. All patients underwent 18F-FDG-PET/computed tomography (CT) of the thorax and neck. Biomarkers linked to inflammation and atherosclerosis were also determined. The primary outcome was AI in ascending aorta (AA) measured as mean maximum target-to-background ratio (TBRmax). The independent relationships between HIV status and both TBRmax and biomarkers were evaluated by multivariable linear regression adjusted for body mass index, creatinine, statin therapy, and atherosclerotic cardiovascular 10-year estimated risk (ASCVD). RESULTS: Unadjusted mean TBRmax in AA was slightly higher but not statistically different (P = .18) in PLWH (2.07; IQR 1.97, 2.32]) than uninfected people (2.01; IQR 1.85, 2.16]). On multivariable analysis, PLWH had an independent risk of increased mean log-TBRmax in AA (coef = 0.12; 95%CI 0.01,0.22; P = .032). HIV infection was independently associated with higher values of interleukin-10 (coef = 0.83; 95%CI 0.34, 1.32; P = .001), interferon-γ (coef. = 0.90; 95%CI 0.32, 1.47; P = .003), and vascular cell adhesion molecule-1 (VCAM-1) (coef. = 0.75; 95%CI: 0.42, 1.08, P < .001). CONCLUSIONS: In patients with high cardiovascular risk, HIV status was an independent predictor of increased TBRmax in AA. PLWH also had an increased independent risk of IFN-γ, IL-10, and VCAM-1 levels.

Peripheral intravascular lithotripsy for transcatheter aortic valve implantation: a multicentre observational study.

BACKGROUND: The presence of severe calcific atherosclerosis at the iliofemoral axis may preclude transcatheter aortic valve implantation (TAVI) by the transfemoral (TF) approach. Intravascular lithotripsy (IVL) is a novel technology that fractures intimal/medial calcium and increases vessel compliance allowing TF TAVI in selected patients with peripheral artery disease (PAD). AIMS: The aim of this study was to report on the safety and efficacy of IVL-assisted TF TAVI in an all-comers population. METHODS: Clinical, imaging and procedural data on all consecutive patients treated by IVL-assisted TF TAVI in six high-volume European centres (2018-2020) were collected in this prospective, real-world, multicentre registry. RESULTS: IVL-assisted TF TAVI was performed in 108 patients, increasing from 2.4% to 6.5% of all TAVI from 2018 to 2020, respectively. The target lesion was most often localised at the common and/or external iliac artery (93.5% of cases; average TL-MLD 4.6±0.9 mm with 318 degrees of calcium arc). Transfemoral aortic valve delivery was successful in 100% of cases; final procedural success in 98.2% (two conversions to cardiac open surgery for annular rupture and valve migration). Complications of the IVL-treated segments consisted of 1 perforation and 3 major dissections requiring stent implantation (2 covered stents and 2 BMS). Access-site-related complications included 3 major bleedings. Three in-hospital deaths were recorded (2.8%, 1 failed surgical conversion after annular rupture, 1 cardiac arrest after initial valvuloplasty, 1 late hyperkalaemia in renal dysfunction). CONCLUSIONS: IVL-assisted TF TAVI proved to be a safe and effective approach, which helps to expand the indications for TF TAVI in patients with severe calcific PAD. However, these patients continue to have a higher-than-average incidence of periprocedural complications.