Transfemoral Transcatheter Aortic Valve Implantation Research Articles

Long-term mortality and impact of implantation-associated factors on the incidence of patient-prosthesis mismatch after transcatheter aortic valve implantation in patients with small annuli

BackgroundProsthesis-patient mismatch (PPM) is a common phenomenon after transcatheter aortic valve implantation (TAVI), especially in patients with small aortic annuli (SAA). Whether factors during implantation, such as the implantation depth, have an impact on the occurrence of PPM is currently unclear. Objectives of our study were (i) to investigate the influence of procedure planning and implantation-related factors on the occurrence of PPM and (ii) to evaluate the impact of PPM on long-term mortality after TAVI. Methods and ResultsData from 315 patients with SAA, defined as multidetector computed tomography-derived annulus area < 400 mm2, treated with transfemoral TAVI between 2014 and 2021 were retrospectively analyzed. TAVI was performed with ballon-expandable valves (BEV) in 113 and self-expanding valves (SEV) in 202 cases. PPM was defined according to VARC 3 and follow-up was obtained within 5 years after TAVI.Overall, PPM occurred in 121 patients (38.4%) and was significantly more frequent in patients treated with BEV (54.9%) than with SEV (29.2%, p<0.001). Evaluation of planning- and implantation-related factors found that deeper implantation of BEV significantly increased the risk of PPM (p=0.014), while no association was observed in SEV. Overall mortality at 3 and 5 years was 25.5% and 43.1%, respectively, without significant differences between patients with and without PPM. ConclusionPPM occurred frequently, especially after BEV implantation. In these patients, implantation depth was identified as a predictor of PPM while no association was found for SEV implantation. In addition, there was no difference in longer-term mortality between patients with and without PPM.

Anesthésie locale comparée à l'anesthésie locorégionale dans les procédures TAVI par voie transfémorale

IntroductionTranscatheter aortic valve implantation (TAVI) has become the treatment of choice for the most fragile patients with severe aortic stenosis. The transfemoral route is preferred as the simplest and safest. The aim of our study was to compare the efficacy, tolerance and safety of local vs. locoregional anesthesia in trans-femoral TAVI procedures. Material and methodThis was a single-center retrospective study. Patients treated with femoral TAVI between February 25 and November 15, 2022 at the University Hospital of Reims were included, and two groups (local and locoregional anesthesia) were compared. ResultsTAVI success rate (92.9%), death rate (3.0%) and procedure duration (90.5 ± 13.5 minutes) did not differ between groups (p = 0.18, 0.15 and 0.55 respectively). For intra- and post-procedural treatments, the use of sedation, analgesics and benzodiazepines did not differ between groups. The cumulative dose of Remifentanil used per-procedure was lower in the local anesthesia group than in the locoregional anesthesia group (148.6 ± 71.9 mcg vs. 208.9 ± 110.0 mcg; p = 0.025). ConclusionsIn this non-randomized retrospective study, local and locoregional anesthesia had comparable safety and efficacy in transfemoral TAVI procedures. In a constrained context and with a view to simplification, these results encourage transfemoral TAVIs to be performed under local anaesthesia, and to consider a “PCI-like” approach, without the presence of an anaesthetist, for selected patients without respiratory, musculoskeletal or agitation disorders, or vascular approach difficulties.

Comparison of strategies for vascular ACCESS closure after transcatheter aortic valve implantation: the ACCESS-TAVI randomized trial.

Data from randomized trials investigating different access closure strategies after transfemoral transcatheter aortic valve implantation (TF-TAVI) remain scarce. In this study, two vascular closure device (VCD) strategies to achieve hemostasis after TF-TAVI were compared. The ACCESS-TAVI (Comparison of Strategies for Vascular ACCESS Closure after Transcatheter Aortic Valve Implantation) is a prospective, multicenter trial in which patients undergoing TF-TAVI were randomly assigned to a strategy with a combined suture-/plug-based VCD strategy (suture/plug group) using one ProGlideTM/ProStyleTM (Abbott Vascular) and one Angio-Seal® (Terumo) versus a suture-based VCD strategy (suture-only group) using two ProGlidesTM/ProStylesTM. The primary endpoint was a composite of major or minor access site-related vascular complications during index hospitalization according to Valve Academic Research Consortium (VARC)-3 criteria. Key secondary endpoints included time to hemostasis, VARC-3 bleeding type ≥2 and all-cause mortality over 30 days. Between September 2022 and April 2024, 454 patients were randomized. The primary endpoint occurred in 27% (62/230) in the suture/plug group and 54% (121/224) in the suture-only group (relative risk [RR] 0.55 [95% confidence interval: 0.44;0.68]; p<0.001). Time to hemostasis was significantly shorter in the suture/plug group compared to the suture-only group (108±208 s vs. 206±171 s; p <0.001). At 30 days, bleeding type ≥2 occurred less often in the suture/plug group compared to the sutureonly group (6.2% vs. 12.1%, RR 0.66 [0.43;1.02]; p=0.032), with no significant difference in mortality. With regard to the composite of major or minor access-related vascular complications, a combined suture-/plug-based VCD strategy was superior to a suturebased VCD strategy for vascular access closure in patients undergoing TF-TAVI.

Comparison of patients with occlusive or hemorrhagic access site complications requiring reintervention after percutaneous transfemoral transcatheter aortic valve implantation.

Background: Transcatheter aortic valve implantation (TAVI) via transfemoral (TF) access is increasingly integral to aortic valve disease treatment, expanding beyond high-risk patients. Despite technical advancements, access-related vascular complications, occurring in approximately 10% of TAVI procedures, remain a substantial challenge. Objective: This study investigated the clinical and morphological characteristics of percutaneous TF-TAVI patients experiencing occlusive (OC) and hemorrhagic (HC) complications managed with surgical or endovascular reintervention. Methods: The cohort included patients from a Dutch and a German tertiary referral hospital, managed with TF-TAVI procedures between 2017 and 2021 that required reintervention for OC or HC. Demographics, comorbidities, procedural details, and preoperative imaging data were collected and compared between groups. Results: Among 109 TF-TAVI patients, 32 with OC and 77 with HC required reintervention. The OC group presented significantly smaller access arterial diameters (common femoral artery: OC 6.7 mm vs. HC 8.9 mm, p<.001; external iliac artery: OC 7.2 mm vs. HC 8.3 mm, p<.001; common iliac artery: OC 9.4 mm vs. HC 10.5 mm, p=.012) while the HC group presented higher tortuosity index (TI) (OC 1.24 vs. HC 1.30; p=.017). No differences were observed regarding baseline characteristics, vessel calcification or vascular closure device use. Conclusions: In patients requiring reintervention following TF-TAVI, smaller arterial diameters were associated with OC, while higher TI was linked to HC. These findings emphasize the importance of preoperative imaging in developing individualized prevention strategies.

Single arterial access versus standard access in TAVI: results from a large multicenter registry

Abstract Background The transfemoral approach has become the gold standard primary access for transcatheter aortic valve implantation (TAVI) due to low complication rates. An additional secondary access (ScA) is used for angiographic guidance of the procedure. Recently, small, single-center studies demonstrated feasibility of single-access for transfemoral TAVI without a secondary access. However, comparative and large-scale data are missing. Purpose We assessed vascular and bleeding complications of ScA and Single access (SA) approaches in a large multicenter registry to evaluate both strategies. Methods The PULSE registry (Plug or sUture based vascuLar cloSurE after TAVI) retrospectively evaluated data of 10,120 patients who underwent transfemoral TAVI at 10 high-volume German heart centers from 2016 to 2021. In 9,457 patients who qualified for analysis ScA (80.7% femoral, 19.3% radial) were performed in 8709 (92%) and SA in 748 (8%). Outcomes were evaluated in accordance with the Valve Academic Research Consortium (VARC-3) definitions. Results Median age was 81.9[IQR 78.2, 85.1] years and 48.9% of patients were female (median logistic EuroSCORE II: 3.3% [IQR 2.1, 5.6]). Peripheral artery disease was comparable between groups (13.5 vs. 14.0%, p=0.73). While overall major access-related vascular complications did not differ significantly (6.1% vs. 4.8%, p=0.20), there was a higher incidence of minor complications for ScA compared to SA (9.0% vs. 2.8%, p&amp;lt;0.001). Secondary access complications amounted to 2.7% in the ScA group and were mainly characterized as bleeding (1.2%) and pseudoaneurysms (1.2%) mostly treated conservatively (1.2%), yet in some cases surgical repair was needed (0.8%). No significant difference was observed regarding type III/IV bleeding (4.1% vs. 4.3%, p=0.91), stroke rate (2.4% vs. 3.6%, p=0.05), stage III/IV acute kidney injury (2.4% vs. 2.4%, p=1.00) or all-cause 30-day mortality (5.8% and 5.7%, p=0.99) for ScA compared to SA groups. Conclusion In patients treated with transfemoral TAVI, a single access approach was associated with lower rates of minor access-related vascular complications without compromising overall outcomes, suggesting potential benefits of a minimally-invasive TAVI approach with the omission of additional vascular access.

Predisposing and precipitating factors of post-operative delirium after transfemoral TAVI

Abstract Background Transcatheter aortic valve implantation (TAVI) represents the treatment of choice for aortic stenosis (AS) patients at higher age (&amp;gt; 75y) or with relevant comorbidities. Post-operative delirium (POD) is a frequent complication which has been associated with worse outcome. Thus, preventive options are highly needed. The aim of our single-center study was to investigate predisposing and precipitating factors of POD after transfemoral TAVI, with a focus on the influence of anaesthesia. Methods Risk factors for POD after TAVI were analysed in 2 merged cohorts of 480 study patients (43% women; mean age 80 years), enrolled in 2017-2022 (n=375, TAVI in 95% in general anaesthesia) and in 2022-2024 (n=105, TAVI in 91% in local anaesthesia). Incidence of POD was evaluated retrospectively by nursing documentation, medical records, and DRG coding. The association of demographics, comorbidities, echo parameters, procedural parameters, anaesthesia, and peri-procedural complications with POD incidence was investigated. Results In total, 29 patients (6%) developed POD, with a tendency towards a lower incidence in the later cohort (6.7% vs. 3.8%; p=0.28). Regarding baseline characteristics, patients experiencing POD were more likely to be male (p=0.03), frail (Katz Index &amp;lt;6, p=0.049), and to suffer from low-gradient AS (p=0.005 for paradoxical, p=0.02 for classical low-flow, low-gradient AS; see also fig. 1A). Total procedure time was significantly longer in patients with POD (median, 86 vs. 62 min, p=0.004; fig 1B), and a tendency towards a more frequent implantation of other than ballon-expandable valves could be observed (p=0.07). Concerning the role of anaesthesia, POD did not differ significantly after general anaesthesia (n=24/360, 6.7%), conscious sedation (n=1/19, 5.3%), and local anaesthesia (n=4/100, 4%) (p=0.38). Regarding procedural complications, POD patients were characterized by lower minimum hemoglobin post-TAVI (9.3 vs. 10.1 g/dl, p=0.05; fig. 1C) and higher incidences of intra-procedural resuscitation (11% vs. 2%, p=0.03), cerebrovascular accidents (10% vs. 2%, p=0.04) and new permanent pacemaker implantations (25% vs. 10%, p=0.02). In POD patients, long-term survival after TAVI was significantly reduced, with a median survival of only 2 years (Kaplan-Meier curves in fig. 2; p=0.001). Conclusions POD after TAVI stays common and unfavourable. The role of anaesthesia seems less pronounced than expected. Total procedure time and relevant anaemia after TAVI emerged as most important modifiable risk factors. Future research is warranted, since strategies to reduce precipitating factors for POD may have a significant impact on post-TAVI outcomes.Selected risk factors for PODConsequence of POD: Reduced Survival

Procedural and clinical outcomes according to ultrasound-guided access in TAVI: a propensity-matched comparative sub-analysis from the PULSE registry

Abstract Background Access-related vascular and bleeding complications during transcatheter aortic valve implantation (TAVI) are associated with significant morbidity and mortality. Ultrasound-guided (USG) puncture may reduce the incidence of these events, particularly in large-bore arterial access. However, large-scale data on this approach are limited and it has not yet fully been implemented into standard clinical practice during TAVI. Purpose We compared access-related vascular and bleeding complications in USG versus fluoroscopy-guided (FG) access from a large multicenter TAVI registry. Methods The PULSE registry (Plug or sUture based vascuLar cloSurE after TAVI) retrospectively evaluated data of 9,295 patients who underwent transfemoral TAVI at 10 high-volume German heart centers from 2016 to 2021. USG and FG access were performed in 1,992 (21.4%) and 7,303 (78.6%) patients, respectively. A propensity score was used to match 1,023 FG with 1,023 USG access patients in a 1:1 fashion. The primary endpoint was a composite of minor and major vascular complications at the TAVI-access site or bleeding type II-IV. Outcomes were evaluated in accordance with the Valve Academic Research Consortium (VARC-3) definitions. Results Mean age was 81.9±6.25 years and 48.0% of patients were female. Comorbidities and clinical variables were well-balanced in matched groups. The overall risk profile was comparable in USG vs. FG (mean EuroSCORE II: 3.4 [2.1, 6.4] vs. 3.6 [2.2, 5.7], p=0.54). The primary end point occurred in 12.0% in the USG and 17.7% in the FG group, p&amp;lt;0.001. While major large bore access-related vascular complications did not differ significantly (3.5% vs. 4.2%, p=0.49), there was a trend towards lower minor complications for USG compared to FG (5.9% vs. 7.8%, p=0.096). Large bore access-related bleeding occurred in 5.5% versus 7.8% (p=0.04) of patients. Endovascular balloon inflation was required in 0.6% and 3.3% (p&amp;lt;0.001) of all large-bore access vascular complications. Stroke (1.7% vs. 1.5%, p=0.86) and stage III/IV acute kidney injury (3.0% vs. 2.2%, p=0.42) were similar in both groups. Conclusion In patients treated with transfemoral TAVI, ultrasound-guidance for gaining access was associated with lower rates of access-related vascular complications or type II-IV bleeding. Endovascular treatment was required more frequently in case of a fluoroscopy-guided approach. These findings challenge the fact that most TAVI procedures were performed with fluoroscopy-guidance.

Long-term clinical and imaging outcomes of patients undergoing percutaneous femoral intervention following TAVI-related vascular access complications

Abstract Introdcution: Vascular access complications (VAC) are the most common in-hospital adverse event following transcatheter aortic valve implantation (TAVI). Often, ileo-femoral VAC requires bail-out percutaneous interventions with either prolonged balloon inflation and/or stent implantation. The long-term outcomes of these procedures have not been characterized. We aim to assess the clinical and imaging outcomes of patients who underwent bailout percutaneous vascular interventions due to VAC following TAVI. Methods Single-centre prospective study including all consecutive patients with a VAC following trans-femoral TAVI, between 2015-July 2023. VAC was defined as uncontrolled bleeding, acute occlusion or flow limiting stenosis of the femoral vessel leading to percutaneous treatment. Clinical and imaging follow-up was performed with bilateral arterial ultrasound (US) Doppler to assess patency and peak systolic velocity of common femoral arteries. Results A total of 1518 patients underwent TF-TAVI, of which 107 (7%) underwent concomitant ileo-femoral percutaneous angioplasty (PTA) intervention in the same day as TAVI. In patients submitted to PTA, 7 were treated to gain access for TAVI, and 100 (7%) were performed to treat vascular access complications. At a mean follow-up time of 23±3 months, 37 patients died (37%), 6 (16%) from in-hospital complications and 31 (84%) from non-vascular causes after discharge. From the surviving 63 patients (study group) – mean age 83±6 years-old, 29% male, 46% with previous peripheral arterial disease –, 24 underwent bilateral US. Unable to perform imaging on 39 patients due to geographical or mobility issues. At a mean follow-up time of 30±23 months, only 6 patients (10%) reported intermittent claudication, of which 4 (67%) had pre-TAVI symptoms. No patient had at rest symptoms or amputation history. All but one had patent vessel on US. The mean peak systolic velocity of the treated vessel and the contralateral vessel were 71.1±22.9cm/s and 73.1±23.8cm/s, respectively, with no statistically significant difference between them in each patient (mean difference 1.9±25.4, p=0.709). We found no statistically significant differences between peak systolic velocities between both vessels in each patient, accordingly with the treated vessel (Table 2). Conclusion This prospective study shows that patients submitted to percutaneous bailout iliofemoral interventions have a very low rate of lower limb adverse events with very good patency rates at mean follow up of 2.5 years.

Safety of electrophysiological study in atrioventricular block risk stratification in new-onset persistent left bundle brunch block following transcathether aortic valve implantation

Abstract Background A significant percentage of patients develops a persistent complete left bundle branch block (LBBB) following TAVI. Electrophysiological (EP) study could be useful to stratify the risk of atrioventricular block (AVB) in these patients, guiding the need of follow-up and the indication of definite pacemaker. Purpose The primary objective of the study was describing the incidence of bradyarrhythmic events in the 30-day follow-up of patients with new-onset LBBB: AV block with ECG long-term monitoring system (Nuubo) in patients with negative EP study, and ≥ 5 % of ventricular stimulation in patients with positive EP study and pacemaker implantation. Methodology Observational prospective study of consecutive patients without previous permanent pacemaker implantation where transfemoral TAVI was implanted between 2021 and 2023. In case new-onset complete LBBB was present after TAVI, an EP study was performed. EP study was considered positive when His-Ventricule interval was more than 70ms, or after procainamide infusion at 10mg/kg, more than 100ms or more than double the basal HV interval. In case EP was positive, a permanent pacemaker was implanted. In case EP was negative, a 30-day follow-up with ECG long-term monitoring system (Nuubo) was performed. Results In this cohort, 266 patients without pacemaker following TAVI were included. Persistent new-onset left bundle branch block was present in 10,15% of patients (n=27). EP study was positive in 29.62% of patients (n=8), following a definite pacemaker implantation. During follow-up, only one patient (12.5%) was dependent of ventricular stimulation. The group with negative EP study (n=19) were monitored with a 30-day ECG long-term monitoring system (Nuubo). No bradyarrhythmic events were registered in this group. Conclusions Approximately one tenth of patients develop persistent new-onset LBBB after TAVI. Events were seldom in both study groups. Positive EP study patients were dependent of ventricular stimulation in 12.5% of cases, and there was no bradyarrhythmic event registered in EP negative group. EP study could be a safe tool to stratify AVB risk in new-onset LBBB following TAVI.

TAVI for treating severe aortic valve disease in cardiogenic shock: a single centre experience

Abstract Introduction Recent evidence shows the safety and efficacy of TAVI in patients with aortic valve disease (AVD) presenting in cardiogenic shock (CS). However, there is limited data regarding CS management in the cardiac intensive care unit (CICU) and its outcomes. We aimed to describe the CS features, pre-TAVI management and short-term clinical outcomes of a cohort of CS patients (pts) submitted to TAVI. Methods Single-centre retrospective registry of consecutive pts with AVD undergoing TAVI in CS, from January 2020 to October 2023. CS was defined as pre-procedural hypotension/hypoperfusion requiring vasoactive drugs or mechanical circulatory support (MCS) devices. The severity of CS was defined according to the SCAI classification. Procedural related outcomes according to the VARC-3 criteria and 30-day mortality were assessed. Results A total of 16 pts (1% of our global TAVI cohort, 62% male, mean age 79±5 years) meet the inclusion criteria. The majority (n=13) presented severe aortic stenosis, two had degenerated aortic bioprosthesis with severe regurgitation and one had native valve severe regurgitation. 6 pts (38%) had isolated left ventricle (LV) dysfunction and 10 (62%) had biventricular dysfunction. The admission LVEF was 33±8% and the mean transaortic gradient for those with aortic stenosis was 46±13mmHg. The EuroSCORE II estimated for a single non-CABG emergency procedure was 37±15%. All patients were refused for surgical treatment upon Heart Team discussion. At admission, 12 (75%) patients presented in CS SCAI-C, 1 (6%) in SCAI-D and 3 (19%) in SCAI-E. These last 3 patients presented in cardiac arrest upon admission to the CICU (time to ROSC from 2 to 15 minutes). The peak lactate level at 48 hours was 3.4 mmol/L [2.1-5.1] and the highest Vasoactive-Inotropic Score (VIS) during admission was 21 [11-45]. None of the patients needed MCS pre-TAVI. 5 (31%) patients required invasive mechanical ventilation and 5 (31%) renal replacement therapy. Median time between CICU admission and transfemoral TAVI was 2.5 days [IQR 1-7]. Procedural success was 100%, with 57% receiving a balloon-expandable and 43% a self-expandable valve. Post-TAVI CICU length of stay was 6 days [IQR 5-9]. Most common procedural complication were the need for permanent pacemaker implantation (n=2, 12%) and access-related bleeding (n=2, 12%). Hospital length-of-stay was 20±15 days. Thirty-day mortality was 12% (n=2). Conclusion In this cohort of CS patients selected for TAVI treatment, procedural success was achieved in all cases. While complications were similar to the general TAVI population, in-hospital mortality remained high but very acceptable. These results suggest that, if correctly selected, aortic valve disease patients in CS represent a niche for whom brief stabilization and urgent percutaneous valve treatment might impact their dismal prognosis.

Procedure-related radiation and contrast use during TAVI procedures with balloon-expandable versus self-expanding devices

Abstract Background Transcatheter aortic valve implantation (TAVI) procedures show some fundamental differences, depending on the use of balloon-expandable (BEV) or self-expanding (SEV) devices. We aimed to assess, how it translates into contrast use and radiation exposure. Methods From five high volume European centers consecutive patients were included, who underwent transfemoral TAVI procedure. Patient- and procedural characteristics were recorded and compared in relation to the used TAVI device. Results In total 3131 patients were included. 53% were male and the mean age was 80±9 years. 1273 (41%) patients were treated with BEV, while 1858 (59%) with a SEV system. Patients, receiving SEV were older (81±9 vs 79±9 years, respectively; p&amp;lt;0.01) and were more often females (57% vs 33%, respectively; p&amp;lt;0.01). There was also a trend for less peripheral artery disease (14% vs 17%, respectively; p=0.06). Overall total radiation time was 15±9 min., that was markedly shorter for BEV than for SEV (13±8 vs. 17±10 min., respectively; p&amp;lt;0.01). On average 130±65 mL contrast media was used, that was less for BEV than for SEV (104±52 vs. 148±67 mL, respectively; p&amp;lt;0.01) In terms of contrast use, retrievable- and non-retrievable SEVs were comparable (148±71 vs. 146±63 mL, respectively; p=0.41), but both markedly higher, than for BEVs (p&amp;lt;0.01 for both). Non-retrievable SEVs required less radiation (14±7 vs. 18±10 mins, respectively; p&amp;lt;0.01), but still markedly more than BEVs (p&amp;lt;0.01). Conclusion TAVI procedures with BEV require shorter radiation exposure for the team and markedly less contrast, than with SEV. This might be reasonable to consider during patient-tailored procedure planning.Radiation and contrast usage during TAVI

TAVI-related vascular access complications: are Viabahn stents a good option?

Abstract Background Vascular access complications (VACs) remain one of the biggest challenges when performing transcatheter aortic valve implantation (TAVI). Historically, concerns regarding stent placement in flexing points have been a deterrent to the percutaneous treatment of VACs, due to the potential development of claudication over time. The Viabahn stent, being a covered stent that offers flexibility and conformability, may be well-suited for deployment in these anatomies. Purpose This study aimed to evaluate the safety and efficacy of the iliofemoral Viabahn stenting for treating TAVI-related VACs. Methods Retrospective analysis of patients submitted to Viabahn stenting in the iliofemoral sector for TAVI-related VACs in a single tertiary centre between January 2017 and October 2023. Baseline characteristics, procedure data and complications were noted according to the Valve Academic Research Consortium-2. Results A total of 722 patients were submitted to transfemoral TAVI during the study period. Of these, 25 (3.6%) underwent Viabahn stenting to treat TAVI-related VACs and were included in this study. Patient mean age was 82.1±6.13 years, 61.2% were male. At the baseline, patients had a mean Euroscore II of 2.73±1.91. A unilateral access approach was used in 40% of cases. The median size of the main access sheath was 14 Fr [IQ 14-16], and the closure devices deployed were Manta® in 72%, and Perclose® in 28%. The Viabahn stent treated different types of VACS, including vessel rupture in 56%, acute dissection in 28% (12% with no antegrade flow), and failed sealing in 16%. The complicated artery was the common femoral in 82%, and the external iliac in 18%. Percutaneous treatment with Viabahn stenting was successful in 92% of cases. In two cases (8%), one of acute occlusion and one of vessel rupture, vascular surgery was required. During the hospital stay, there were no further vascular or hemorrhagic complications. After a mean follow-up of 15 months, 20% of patients were evaluated by Doppler which showed no signs of restenosis or stent complications. Only one patient experienced lower limb claudication at 1 year due to stent restenosis detected in the CT scan, which was managed with medical therapy. There were no other adverse vascular events during follow-up. Conclusion Our study suggests that Viabahn stenting emerges as a valuable therapeutic option, ensuring long-term safety and efficacy, in the complex realm of TAVI-related vascular complications.

Close clinical monitoring of patients after TAVI implantation using artificial intelligence with a virtual voice assistant

Abstract Introduction The number of procedures and patients candidates for transcatheter aortic valve implantation (TAVI) has increased considerably due to population ageing and the rise in scientific evidence supporting this technique in patients with increasingly lower surgical risk. Early discharge would allow for a more efficient use of available resources, in addition to improving patients’ functionality and quality of life. Objective The use of a virtual voice assistant based on artificial intelligence, could be an effective and safe alternative to closely monitor patients after TAVI implantation in order to facilitate early identification of complications and a more efficient use of the resources available in Cardiology services. Material and methods Observational, prospective, single-center and consecutive study of the implementation of a technology based on artificial intelligence and natural language processing to monitor all patients undergoing transfemoral TAVI implantation, according to usual clinical practice, in the hemodynamics unit of our hospital in the year 2023. The virtual voice assistant, "Lola", carries out a telephonic follow-up during week 1, week 2, month 1, month 3 and 12. In these calls, it asks a series of questions mainly related to vascular access and with the patient's cardiovascular situation. After finishing the call, all the information collected is uploaded to a web platform where we monitor the collected data and thus take the appropriate measures. Results After 12 months, 274 patients have been included to whom 1,039 calls have been made with a total of 385 hours of autonomous conversation. In 44% of the calls, no alerts were detected and, therefore, did not required further review. From the remaining calls, a total of 926 alerts were collected, the predominant ones being: dizziness (24.9%), contact with the emergency services (11.3%) and alteration of general status (10.4%). The number of alerts decreases as the follow-up progresses, reflecting the need for closer monitoring in the initial stages after implantation. These alerts generated at least one intervention in 57% of the calls, the predominant ones being: medical contact (43.0%), nursing contact (26.3%) and medication adjustment (4.0%). These calls resulted in a total of 15 in-person examinations (5.4% of patients), detecting in 2 of them a 3rd degree atrioventricular block, in 3 a femoral pseudoaneurysm and in 1 a critical stenosis of the common femoral artery. According to a patient survey, 88.9% of patients were satisfied or very satisfied (Customer Satisfaction score 4.68/5). Conclusions The application of artificial intelligence permits strict control of the patient after TAVI implantation, thus facilitating early detection of complications. Patient satisfaction regarding this follow-up system was very high.

Successful surgical repair of aortic root rupture during transcatheter aortic valve implantation: a case report

BackgroundAortic root rupture is a rare but potentially fatal complication of transcatheter aortic valve implantation (TAVI). Herein, we report a case of aortic root rupture during TAVI that was successfully managed with partial aortic root repair and aortic valve replacement.Case presentationAn 83-year-old woman with severe bicuspid aortic stenosis underwent transfemoral TAVI using a 26 mm SAPIEN 3 Ultra RESILIA valve. Soon after valve implantation, transesophageal echocardiography detected pericardial effusion, which was accompanied by immediate hemodynamic instability. Subxiphoid pericardial drainage was performed, and extracorporeal membrane oxygenation was promptly initiated. Owing to the eruptive hemorrhage, we converted to open-heart surgery. Direct visualization enabled the detection of the aortic root rupture and the performance of partial aortic root repair using bovine pericardium and aortic valve replacement using a 19 mm INSPIRIS RESILIA valve. The patient was transferred to a different hospital 60 days after surgery without complications and is currently doing well as an outpatient.ConclusionsIn the present case, prompt treatment decisions and smooth cooperation among the institutional heart team led to the successful repair of aortic root rupture during TAVI and good clinical outcomes.

Prognostic utility of mid-regional pro-adrenomedullin and growth differentiation factor 15 in patients undergoing transfemoral transcatheter aortic valve implantation.

Risk prediction in patients with severe, symptomatic aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) remains an unsolved issue. In addition to classical risk scoring systems, novel circulating biomarkers like mid-regional pro-adrenomedullin (MR-proADM) and growth differentiation factor 15 (GDF-15) may be of value in assessing risk. Consecutive patients undergoing elective transfemoral TAVI were included in this prospective observational study. Baseline information, imaging findings, blood samples, and clinical outcomes were collected. Blood levels of the classical biomarkers interleukin-6 (IL-6) and high-sensitivity C-reactive peptide (hsCRP) and of the novel biomarkers MR-proADM and GDF-15 were measured and their predictive utility for mortality assessed. The study cohort consisted of 92 patients undergoing TAVI. The median age was 80.7years [IQR 77.2;83.3], and 48 (52.2%) were male. Analysis of the area under the curve (AUC) of the receiver-operating characteristics showed that the hsCRP levels discriminated poorly (AUC 0.66, 95% CI [0.52;0.8], p = 0.027), whereas all other biomarkers reached a higher level of discrimination (IL-6: AUC 0.76, 95% CI [0.66;0.86], p < 0.001; MR-proADM: AUC 0.73, 95% CI [0.61;0.85], p = 0.002; GDF-15: AUC 0.73, 95% CI [0.61;0.85], p = 0.002). Kaplan-Meier analysis in conjunction with Youden J-statistics yielded the optimal cutoff points for each biomarker to predict survival: IL-6 4.65pg/mL, hsCRP 12.9mg/L, MR-proADM 1.02nmol/L, and GDF-15 2400.1pg/mL. Novel circulating biomarkers like MR-proADM and GDF-15 may provide additional value in predicting survival after TAVI.

Costs Associated with Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement in Korea.

This study compared the costs associated with transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in Korea by utilizing the National Health Insurance Service database. Between June 2015 and May 2019, 1,468 patients underwent primary isolated transfemoral TAVI, while 2,835 patients received primary isolated SAVR with a bioprosthesis. We assessed the costs of index hospitalization and subsequent healthcare utilization, categorizing the cohort into 6 age subgroups: <70, 70-74, 75-79, 80-84, 85-89, and ≥90 years. The median follow-up periods were 2.5 and 3.0 years in the TAVI and SAVR groups, respectively. The index hospitalization costs were 41.0 million Korean won (KRW) (interquartile range [IQR], 39.1-44.7) for the TAVI group and 24.6 million KRW (IQR, 21.3-30.2) for the SAVR group (p<0.001). The TAVI group exhibited relatively constant index hospitalization costs across different age subgroups. In contrast, the SAVR group showed increasing index hospitalization costs with advancing age. The healthcare utilization costs were 5.7 million KRW per year (IQR, 3.3-14.2) for the TAVI group and 4.0 million KRW per year (IQR, 2.2-9.0) for the SAVR group (p<0.001). Healthcare utilization costs were higher in the TAVI group than in the SAVR group for the age subgroups of <70, 70-74, and 75-79 years, and were comparable in the age subgroups of 80-84, 85-89, and ≥90 years. TAVI had much higher index hospitalization costs than SAVR. Additionally, the overall healthcare utilization costs post-discharge for TAVI were also marginally higher than those for SAVR in younger age subgroups.

Upper- vs Lower-Extremity Secondary Access During Transcatheter Aortic Valve Implantation

An upper-extremity approach for secondary access during transfemoral transcatheter aortic valve implantation (TAVI) may reduce clinically relevant secondary access site-related bleeding. To investigate the safety and efficacy of an upper-extremity approach compared with a lower-extremity approach in patients undergoing TAVI. The TAVI XS trial was a randomized clinical trial performed between November 28, 2022, and November 15, 2023, with a 30-day follow-up, in 4 TAVI centers in the Netherlands. Eligibility was determined first, and only those patients with severe aortic stenosis and no contraindication for upper- or lower-extremity secondary access were informed about the study and asked to participate. Participants were randomized 1:1 between the upper-extremity approach (radial artery diagnostic access and upper-arm vein for temporary pacing lead placement) and lower-extremity approach (femoral artery diagnostic access and femoral vein for temporary pacing lead placement) for secondary access during TAVI. Primary end point was clinically relevant bleeding (Bleeding Academic Research Consortium type 2, 3, or 5) of the randomized secondary access. Secondary end points included any clinically relevant bleeding, time to mobilization, duration of hospitalization, secondary access failure, and procedural time. Of a total of 324 eligible patients, 238 patients undergoing transfemoral TAVI (mean [SD] age, 79.4 [6.5] years; 150 male [63.0%]; median European System for Cardiac Operative Risk Evaluation II score, 2.2% [IQR, 1.5%-3.5%]) were included. The primary end point occurred in 5 of 119 patients (4.2%) in the upper-extremity group and 16 of 119 (13.4%) in the lower-extremity group (odds ratio [OR], 0.28 [95% CI, 0.10-0.80]; P = .01). Incidence of any clinically relevant bleeding was decreased in the upper-extremity group (25 of 119 [21.0%] vs 41 of 119 [34.5%] patients; OR, 0.51 [95% CI, 0.28-0.91]; P = .02). There was no difference in time to mobilization or duration of hospitalization. Secondary access failure (14 of 119 [11.8%] vs 1 of 119 [0.8%] patients; OR, 15.73 [95% CI, 2.03-121.69]; P = .001) and procedural time (60.0 [IQR, 39.0-88.0; 95% CI, 53.0-70.0] vs 48.0 [IQR, 34.0-64.0; 95% CI, 40.0-55.0] minutes; P = .002) were higher in the upper-extremity cohort. In this randomized clinical trial of patients undergoing transfemoral TAVI, the upper-extremity approach for secondary access was associated with less clinically relevant access site-related bleeding compared with the conventional lower-extremity approach and should be considered to reduce periprocedural bleeding complications. ClinicalTrials.gov Identifier: NCT05672823.

Zero-Contrast Transcatheter Aortic Valve Implantation vs. Standard Practice: Periprocedural and Long-Term Clinical Outcomes.

Background: We aimed to compare the procedural efficacy and long-term clinical results of a totally contrast-free Transcatheter Aortic Valve Implantation (TAVI) procedure (i.e., contrast dye was not used for either the pre-procedural assessment or during the procedure) to those of standard practice in patients with severe renal dysfunction. Methods: All consecutive patients with a glomerular filtration rate (GFR) ≤ 35 mL/min and severe aortic stenosis who were treated with transfemoral TAVI at our Institution were included in the registry. The zero-contrast patients underwent carbon dioxide angiography and a non-contrast CT scan for assessment of vascular access suitability, and aortic annulus sizing was performed by a TEE, and the procedural guidance was fluoroscopic and echocardiographic. Procedural outcomes were evaluated, and clinical long-term follow-up was performed for all included patients. Results: A total of 44 patients (median age, 85 (IQR, 80.75-87.00)) were included in the zero-contrast group (TEE guidance and general anesthesia in 37 (84%) patients), while 63 patients were included in the standard practice arm (82 ± 78 mL of contrast dye used). Procedural success was obtained in 100% of cases. There were no differences in procedural outcomes, including final mean aortic gradients (5.5 (IQR, 5.0-10.0) mmHg in the zero-contrast group vs. 6.0 (IQR, 5.0-10.0) mmHg in the standard practice group) and rate of at least a moderate paravalvular leak (0% vs. 1.6% in the zero-contrast and standard practice groups, respectively; p = 0.31). No differences in AKI during the hospital stay were observed. Over a median follow-up of 3.3 years, there was a significantly lower rate of AKI (1.2% vs. 25.9%, p < 0.001) and rehospitalizations (1.6% vs. 35.5%, p < 0.00) in standard practice group. Conclusions: We showed for the first time the feasibility and efficacy of a totally contrast-free strategy compared to standard practice in TAVI patients with severe renal dysfunction. Besides achieving comparable procedural results, the zero-contrast strategy showed a better long-term clinical outcome in reducing hospital readmissions for kidney function deterioration.

Single-center experience with self-expanding transcatheter aortic valve system for symptomatic high-risk patients with severe aortic regurgitation: One-year outcomes.

To evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) for the treatment of aortic regurgitation (AR). From September 2019 to February 2022, 62 patients who underwent transfemoral TAVI procedure for pure, symptomatic severe AR with the VitaFlow system were enrolled in the current study. The outcomes were assessed according to the Valve Academic Research Consortium 3 criteria. Procedural results and clinical outcomes for 1 year were analyzed. The mean age was 71.56 ± 7.34 years and 58.1% were male. The mean Society of Thoracic Surgeons score was 5.44 ± 3.22%. The device success rate was 79.0%. Only one patient was converted to open surgery. The in-hospital mortality rate was 1.6%. The 1-year all-cause mortality rate was 6.5%. The new permanent pacemaker implantation rate was 29.0% in-hospital and 30.7% at 1-year follow-up. The second valve implantation rate was 14.5%. No patient developed more than moderate paravalvular leakage during follow-up. The mean ejection fraction improved from 54.05 ± 10.83% at baseline to 59.32 ± 8.70% (p < 0.001 compared with baseline) at 12 months. Left ventricular end-diastolic diameter decreased from 61.62 ± 5.58 mm at baseline to 55.20 ± 4.51 mm (p < 0.001 compared with the baseline) at 12 months. Transfemoral TAVI procedure shows efficacy in treating patients with severe pure native AR. The safety is improved with the development of the VitaFlow system.

Coagulation, fibrinolysis and platelet drop in patients undergoing transfemoral transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) leads to transient platelet activation and hypercoagulation status, resulting in thrombocytopenia. This study investigated the associations of coagulation/fibrinolysis status after transfemoral TAVI with valve type, post-TAVI thrombocytopenia, and complication of TAVI. Thrombin-antithrombin complex (TAT) and fibrin/fibrinogen degradation product (FDP) levels were measured before and 1 h, 1 day, and 2 days after TAVI. A percentage drop in platelet count (DPC) was determined from the pre- and lowest post-procedural values. SAPIEN 3 (S3) was implanted in 158 patients and Evolut PRO/PRO+ (Evolut) in 117. Both TAT and FDP increased after TAVI. Pre-TAVI balloon dilatation was generally performed on patients undergoing implantation with Evolut. Peak TAT was then stratified into 4 quartiles (Q1 to Q4). Of all 275 study patients, 69 patients reached ultra-hypercoagulation status (Q4). S3, TAVI without pre-balloon dilatation, DPC and bleeding complications were significantly associated with the ultra-hypercoagulation status after TAVI. TAT was significantly greater 1 h after S3 implantation than Evolut (median [IQR], 43.1 [34.1-59.6] vs. 31.0 [25.0-40.4] ng/mL; p < 0.001). In contrast, FDP levels did not differ between the two at any measurement point. The difference in DPC among the peak TAT quartiles was statistically significant (p < 0.001). The occurrence of bleeding complications was significantly higher in the group with ultra-hypercoagulation status (5.8% vs. 1.0%, p = 0.036). The increase in coagulation status and post-TAVI thrombocytopenia were significantly greater after S3 implantation. Ultra-hypercoagulation after TAVI was related to bleeding complications.