Access For Transcatheter Aortic Valve Implantation Research Articles

Importance of pseudoaneurysms after TAVI - a retrospective analysis of 2063 patients.

Background: Bifemoral arterial access is common in patients undergoing transcatheter aortic valve implantation (TAVI), with a primary treatment access (TAVI access) and a secondary non-TAVI access. Pseudoaneurysm (PSA) is an important complication of femoral arterial puncture. Major vascular complications after TAVI are well described, but little is known about PSA. Patients and methods: A total of 2063 patients underwent transfemoral TAVI between January 2014 and January 2020. Vascular ultrasound of the common femoral artery was assessed before and after TAVI. We compared patient characteristics, periprocedural risk scores, procedural characteristics, and access site bleeding events according to Valve Academic Research Consortium 3 (VARC-3) criteria, length of stay (LOS), and all-cause mortality at one year between patients with (46) and without (2017) PSA. Results: The incidence of PSA after TAVI was 2.2% (46/2063). All PSA were successfully treated with ultrasound-guided manual compression (UGMC) or thrombin injection (UGTI) without complications. Patients with PSA had lower platelet counts (210×1000/μl vs. 234×1000/μl; p<0.05), more heart failure symptoms on admission (91% vs. 25%; p<0.05), were more often treated with (N)OACs for atrial fibrillation (AF; 54% vs. 38%; p <0.05), and were less often treated with aspirin (35% vs. 51%; p<0.03). Multivariate analysis identified secondary access site (odds ratio [OR] 8.11; p<0.001) and (N)OAC therapy (OR 1.31; p = 0.037) as risk factors for PSA development. PSA is associated with VARC-3 type 1-3 access site bleeding and longer LOS (15.2 ± 11.3 d vs. 11.6 ± 8.9 d; p<0.01), but this did not affect one year mortality (17% vs. 14%; p = 0.53). Conclusions: Pseudoaneurysms are an important complication after TAVI and are associated with access site bleeding and prolonged hospital stay. (N)OAC therapy and secondary access are important risk factors. Pseudoaneurysms can be safely and effectively treated with thrombin injection and do not affect one-year mortality.

The role of external iliac artery diameter indexed to BSA score in predicting vascular access complications after transfemoral transcatheter aortic valve implantation.

Aortic stenosis is the most common primary valve disease and requires invasive treatment. Transcatheter aortic valve implantation (TAVI) from a transfemoral access is a routine intervention worldwide. To investigate the correlation between external iliac artery diameter (EIAD) indexed to body surface area (BSA) (EIAD-BSA) and access site complications in patients undergoing TAVI via transfemoral access (TF) (TF-TAVI). Patients underwent TF-TAVI in 2017-2019 at the Upper-Silesian Medical Center in Katowice. Based on the preoperative multi-slice computed tomography (MSCT), pre-specified measurements of the ilio-femoral vessels were performed. The results were indexed to BSA and body mass index (BMI). Complications after TAVI were defined by Valve Academic Research Consortium 3 (VARC-3). The primary outcome regarding the adverse events after TAVI was the composite of access site complications requiring surgical intervention or blood transfusion. The registry included 193 unselected patients with severe symptomatic aortic stenosis. Vascular and access-related complications including bleeding occurred in 17.1% of patients. Major TAVI access site complications (VARC-3) were reported in 5.7% of patients, while minor complications (VARC-3) occurred in 2.6%. EIAD-BSA demonstrated a positive correlation with the access site complications primary endpoint. Patients with greater EIAD-BSA had a numerically higher number of access site adverse events requiring surgical intervention or blood transfusion: n = 12 (5%) vs. n = 4 (4%), p = 0.011. External iliac artery diameter indexed to BSA could be an underestimated indicator of unfavorable outcomes after TF-TAVI, predicting periprocedural access site complications.

Transcatheter Aortic Valve Implantation Access Sites: Same Goals, Distinct Aspects, Various Merits and Demerits.

Transcatheter aortic valve implantation (TAVI) has been established as a safe and efficacious treatment for patients with severe symptomatic aortic stenosis (AS). Despite being initially developed and indicated for high-surgical-risk patients, it is now offered to low-risk populations based on the results of large randomized controlled trials. The most common access sites in the vast majority of patients undergoing TAVI are the common femoral arteries; however, 10-20% of the patients treated with TAVI require an alternative access route, mainly due to peripheral atherosclerotic disease or complex anatomy. Hence, to achieve successful delivery and implantation of the valve, several arterial approaches have been studied, including transcarotid (TCr), axillary/subclavian (A/Sc), transapical (TAp), transaortic (TAo), suprasternal-brachiocephalic (S-B), and transcaval (TCv). This review aims to concisely summarize the most recent literature data and current guidelines as well as evaluate the various access routes for TAVI, focusing on the indications, the various special patient groups, and the advantages and disadvantages of each technique, as well as their adverse events.

Transaxillary versus transfemoral access as default access in TAVI: A propensity matched analysis

BackgroundTransfemoral (TF) access is default in transcatheter aortic valve implantation (TAVI). Transaxillary (TAx) access has been shown to be a safe alternative in case of prohibitive iliofemoral anatomy, but whether TAx as preferred access has similar safety and efficacy as TF access is unknown. The aim of this study was to compare outcomes between patients treated with self-expanding devices using TF or TAx route as preferred access in TAVI. MethodsA single center cohort of 354 patients treated using TAx as preferred access and a multi-center cohort of 5980 patients treated using TF access were compared. Propensity score matching was used to reduce selection bias and potential confounding. After propensity score matching, each group consisted of 322 patients. Clinical outcomes according to VARC-2 were compared using chi-square test. ResultsIn 6334 patients undergoing TAVI, mean age was 81.4 ± 7.0 years, 57% was female and median logistic EuroSCORE was 14.7% (IQR 9.5–22.6). In the matched population (age 79.3 ± 7.0, 50% female, logistic EuroSCORE 13.4%, IQR 9.0–21.5), primary outcomes 30-day and one-year all-cause mortality were similar between Tax and TF groups (30 days: 5% versus 6%, p = 0.90; 1 year: 20% versus 16%, p = 0.17). Myocardial infarction was more frequent in patients undergoing Tax TAVI compared with TF (4% versus 1%, p = 0.05), but new permanent pacemakers were less frequently implanted (12% versus 21%, p = 0.001). ConclusionTAx as preferred access is feasible and safe with outcomes that are comparable to TF access.

Transcatheter Aortic Valve Implantation Using the Transcervical Vascular Access (from a 7-Year Experience from a Swiss Tertiary Center)

The gold-standard transfemoral (TF) access for transcatheter aortic valve implantation (TAVI) is not suitable in 10% to 15% of patients, and alternative accesses are needed. Studies have suggested that the transcervical (TC) access might yield outcomes comparable to the TF access. In our center, TC-TAVI is the first-line alternative to TF-TAVI. We herein present our 7-year experience regarding the use of the TC access in TAVI. We included all consecutive patients referred for TC-TAVI between January 1, 2016 and December 31, 2022. Data regarding the patients' characteristics,perioperative and 30-day outcomes were prospectively collected. Patients were separated into 2 temporal groups (group 1: January 1, 2016 to June 30, 2019; group 2: July 1, 2019 to December 31, 2022) to assess the changes of their characteristics and outcomes over time. A total of 95 patients were included, with more belonging to group 2 (n=56 vs n=39 in group 1). Patients in group 2 were significantly younger (81.0 [interquartile range 77.0 to 87.0] vs 89.0 [interquartile range 83.0 to 92.0] years, p <0.001) and had a higher prevalence of hypertension (87.5% vs 66.7%, p=0.028) and chronic pulmonary disease (35.7% vs 15.4%, p=0.029). There was no significant difference regarding other co-morbidities or surgical scores. All-cause mortality and the risk of stroke at 30days were low and similar (group 2 vs group 1, 3.6% vs 2.5%, p=0.787 and 1.8% vs 0%, p=0.397, respectively), as were the risks of permanent pacemaker implantation, postoperative acute kidney injury, cardiac tamponade, life-threatening bleeding, and major vascular complications. In conclusion, the use of the TC access increased over time. The rates of adverse events did not change, despite patients from mid-2019 onward having slightly more co-morbidities.

Nationwide experience with transcarotid transcatheter aortic valve implantation: Insights from the POL-CAROTID registry.

The carotid artery is an alternative access route for transcatheter aortic valve implantation (TAVI), especially useful in patients unsuitable for traditional access routes including transfemoral (TF), subclavian, transapical, and aortic. To investigate the feasibility and safety of transcarotid (TC) access for TAVI in comparison to the TF approach in a multicenter setting. A total of 41 patients, treated between December 2014 and December 2018, were retrospectively reported to the Polish Registry of Common Carotid Artery Access for TAVI (POL-CAROTID). The median follow-up time was 619 (365-944) days, and Valve Academic Research Consortium-2 (VARC-2) definitions were applied. Clinical outcomes were compared with 41 propensity-matched TF-TAVI patients. The mean (standard deviation [SD]) patients' age was 78.0 (7.2) years, and 29 patients (70.7%) were men. Prohibitive iliofemoral anatomy and/or obesity (46.3%) and/or the presence of a stent graft in the abdominal aorta (31.7%) were the most common indications for TC-TAVI. Device success for TC-TAVI was comparable with the matched TF-TAVI group (90.2% vs. 95.3%, respectively, P = 0.396), and no periprocedural mortality was observed. Moreover, early safety was similar between the two groups (92.7% vs. 95.3%, respectively, log-rank P = 0.658) with only 1 case of non-disabling stroke during the first month after TC-TAVI. Consequently, no cerebrovascular events were observed in the mid-term, and the clinical efficacy of TC-TAVI corresponded well with TF-TAVI (90.2% vs. 92.7%, respectively, log-rank P = 0.716). A total of 4 (9.8%) deaths were noted in the TC-TAVI cohort in comparison to 3 (7.3%) in the TF-TAVI group. The results of the study indicated that the first cohort of Polish patients with implantations of second-generation transcarotid transcatheter heart valves had a similar prognosis to TF-TAVI with regard to safety and feasibility. TC access may be considered an optimal alternative for patients in whom the TF approach is precluded.

Combined CT Coronary Artery Assessment and TAVI Planning

Computed tomography angiography (CTA) of the aorta and the iliofemoral arteries is crucial for preprocedural planning of transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis (AS), because it provides details on a variety of aspects required for heart team decision-making. In addition to providing relevant diagnostic information on the degree of aortic valve calcification, CTA allows for a customized choice of the transcatheter heart valve system and the TAVI access route. Furthermore, current guidelines recommend the exclusion of relevant coronary artery disease (CAD) prior to TAVI. The feasibility of coronary artery assessment with CTA in patients scheduled for TAVI has been established previously, and accumulating data support its value. In addition, fractional flow reserve determined from CTA (CT-FFR) and machine learning-based CT-FFR were recently shown to improve its diagnostic yield for this purpose. However, the utilization of CTA for coronary artery evaluation remains limited in this specific population of patients due to the relatively high risk of CAD coexistence with severe AS. Therefore, the current diagnostic work-up prior to TAVI routinely includes invasive catheter coronary angiography at most centers. In this article, the authors address technological prerequisites and CT protocol considerations, discuss pitfalls, review the current literature regarding combined CTA coronary artery assessment and preprocedural TAVI evaluation, and provide an overview of unanswered questions and future research goals within the field.

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

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

Emergent transcatheter aortic valve implantation combined with enterectomy for acute decompensated heart failure caused by severe aortic stenosis and strangulated femoral hernia.

A 74-year-old female was admitted to our department with orthopnea, oliguria, and vomiting. She had a pacemaker implanted two years ago. Physical examination revealed an 8 cm × 6 cm bulge in the right groin. The transthoracic echocardiography showed that the area of aortic orifice was 0.4 cm2 and the left ventricle ejection fraction (LVEF) was 25%. The Society of Thoracic Surgeons score was 25.6%. Abdominal ultrasound demonstrated right femoral hernia with intestinal obstruction. Because of hemodynamic instability and the risk of intestinal necrosis, emergent transcatheter aortic valve implantation (TAVI) combined with hernia repair was scheduled to perform. The procedure was performed under general anesthesia with intubation. The transesophageal echocardiography (TEE) showed that the maximal and mean pressure gradient was 64 and 35 mmHg, respectively (Panels A–C); coronary angiography indicated no coronary artery stenosis. We chose left femoral artery access for TAVI through a totally percutaneous approach. According to TEE, aortic root angiography and based on the balloon pre-dilation (Panel D), 26 Venus-A self-expandable valve was successfully implanted (Panel F). And then, the right oblique cutdown was performed, and a tense hernial sac was revealed, in which we observed an 8-cm-long necrotic bowel (Panel E). The gastrointestinal surgeon had to resect the strangulated and anastomose the normal bowel. TEE showed that the maximal and mean aortic pressure gradient was 13 and 7 mmHg, respectively (Panels G and H). Thirteen days later after the operation, the patient was discharged from the hospital with no complications. Follow-up echocardiography demonstrated that the device position was appropriate, no perivalvular leakage, and the LVEF increased to 50%.

Using Intravascular Lithotripsy to Facilitate Transfemoral Arterial Access for Transcatheter Aortic Valve Implantation.

Peripheral vascular assessment is important in pre-procedural planning for transcatheter aortic valve implantation (TAVI). While alternative vascular access sites have been used in patients with hostile iliofemoral anatomy, femoral access has been established as the superior access method for procedural outcomes. Intravascular lithotripsy (IVL) can facilitate transfemoral access for TAVI in patients with calcific stenoses of the iliofemoral arteries. This How-To-Do-It article describes the procedural planning and methods for performing IVL in these patients.

Clinical outcomes following single access transfemoral transcatheter aortic valve implantation.

We describe the first experience using calcification of anatomical landmarks to obviate the need for transcatheter aortic valve implantation(TAVI) alignment aortography and secondary TAVI access. TAVI alignment conventionally involves secondary femoral access for contrast aortography using a second catheter. Secondary femoral access accounts for up to 25% of all vascular complications. Heavily calcified aortic leaflets are often visible fluoroscopically and can act as markers for TAVI alignment. We considered 100 consecutive patients for transfemoral TAVI. The first group was considered for a conventional dual access technique and the subsequent group was considered for a single access technique. Relevant baseline, and procedural and outcome measures were recorded. Baseline characteristics were comparable between groups. Balloon-expandable transcatheter heart valves(THV)were used in all cases. THV implantation was successful in 100% of cases with no procedural or in-hospital mortality. Procedural time and contrast use were lower in the single access group. There were no Valve Academic Research Consortium (VARC)-2major vascular complications with the single access technique. This is the first study describing the use of calcification of anatomical landmarks to obviate the need for secondary TAVI access. Notable observations included successful device implantation in all cases, no VARC-2 major vascular complications, comparable rates of paravalvular leak and permanent pacemaker requirement, shorter procedural times, and lower contrast use. Single access TAVI is a viable alternative technique to minimize vascular access, contrast use, and procedural duration in experienced centers and with selected patients, allowing successful device implantation and low complication rates while further streamlining TAVI workflow.

Vascular Access for TAVI in the Era of Intravascular Lithotripsy

Transcatheter aortic valve implantation (TAVI) is an established alternative to surgical aortic valve replacement (SAVR) across a range of indications and surgical risk categories [1]. Peripheral vascular assessment is important in pre-procedural planning for TAVI, as femoral access has been established as the superior access method for procedural outcomes [2,3]. Unfortunately, severe calcific iliofemoral disease can impede femoral access, and alternative access methods, which carry higher risks of peri-procedural complications, were previously used in these cases.

Distal Radial Secondary Access for Transcatheter Aortic Valve Implantation: The Minimalistic Approach

BackgroundAlthough not yet recommended by the guidelines, distal radial access, a new site for cardiovascular interventions, has been rapidly acknowledged and adopted by many centers due to its high rate of success, safety and fewer complications. We present our experience using secondary distal radial access during transcatheter aortic valve implantation (TAVI), proposing a new, even more minimal approach. MethodsAs of November 2020, a systematic distal radial approach as secondary access site for TAVI was adopted in our center. Primary endpoints were technical success and major adverse events (MAEs). Secondary endpoints: the access site complication rate, hemodynamic and clinical results of the intervention, procedural related factors, crossover rate to the femoral access site, and hospitalization duration (in days). ResultsFrom November 2020, 41 patients underwent TAVI using this strategy. Patients had a mean age of 76 ± 11.2 years, 41% were male. Six (14.63%) patients received a balloon-expandable valve and 35 (85.37%) received a self-expandable valve. TAVI was successful in all cases. No complications occurred due to transradial access. Puncture success, defined as completed sheath placement was maximum (N = 41/41,100%) and emergent transfemoral secondary access was not required in any case. Primary transfemoral vascular access site complications occurred in 7 cases (17%) of which 4 (13.63%) were resolved through distal radial access: one occlusion, two flow-limiting stenoses and four perforations of the common femoral artery. There were no additional major vascular complications at 30 days. Overall MACE rate was 2.4%. ConclusionThe use of the distal radial approach for secondary access in TAVI is safe, feasible and has several advantages over old access sites.

TAVI via alternative access routes: patient selection and 10-year center experience

Abstract Background Femoral access is considered the gold standard for transcatheter aortic valve implantation (TAVI). However, this route might be precluded due to the presence of tortuosity, small vessel diameter and/or peripheral artery disease. We aimed to investigate TAVI through an alternative access (AA), focusing on the selection criteria and clinical outcomes compared to the femoral route (TF). Methods We conducted an all-comers longitudinal single-centre prospective registry in whom a TAVI was performed. The feasibility, safety and efficacy of TAVI by means of an access route other than standard TF was assessed, according to the VARC-2 criteria. The prospective surgical criteria used at our institution to accept an AA route were: a) TF deemed inappropriate; b) acceptable haemorrhagic risk; c) acceptable general anaesthesia risk; and d) adequate anatomy and diameter within acceptable range (subclavian, axillar, transaortic) or e) age &amp;lt;85 years and non-frail patient (transapical). The primary endpoint was all-cause death at 1-year. Results From 2008 to 2018, there were 548 patients submitted to TAVI [median age 84 (79–87) years, males 45.4%]. An AA route was used in 100 patients (79 trans-apical, 9 trans-aortic, and 12 trans-subclavian), with a decreasing rate over follow-up (−11% per year). Compared to TF, these patients were younger [80 (77–84) vs. 85 (80–87) years; p&amp;lt;0.001) with a similar baseline surgical risk as per EuroSCORE II [5.1 (3.3–9.0) vs. 4.7 (3.3–7.0); p=0.410). AA patients presented a higher burden of atherosclerotic disease, namely coronary (54.0 vs. 41.3%; p&amp;lt;0.001) and peripheral artery disease (35.0 vs. 16.5%, p&amp;lt;0.001) despite a lower number of other comorbidities (e.g. glomerular filtration rate &amp;lt;50mL/min: 53.1 vs. 64.8%; p=0.030). Left ventricular ejection fraction (56±13 vs 55±12%; p=0.203) and aortic stenosis severity (e.g. valve area: 0.70±0.19 vs. 0.67±0.18cm2; p=0.302) were similar between groups. Haemorrhagic events (minor or major) following TAVI were less often documented in the AA group (11.0 vs 21.7%; p=0.015), contrasting with de novo atrial fibrillation (18.5 vs 7.6%; p=0.048). Overall, 67 patients met the primary endpoint (18.8 vs 16.2%; p=0.584). After adjusted multivariate analysis, the independent predictors of one-year mortality did not include the TAVI access route. Conclusion In the first 10 years of experience, 1 in every 6 patients was treated with a TAVI by means of an AA, most often trans-apically initially and, nowadays, via a trans-subclavian approach. The use of meticulous prospective selection criteria seems to explain the one-year similar results, regardless of the access route. Funding Acknowledgement Type of funding sources: None.

Management strategies for acutely decompensated aortic stenosis

Abstract Background Uncertainty exists over the optimal treatment strategy for patients presenting with acutely decompensated severe aortic stenosis (AS). The available options include a bridging balloon aortic valvuloplasty (BAV) or a direct transcatheter aortic valve implantation (TAVI). Purpose Our study compares TAVI outcomes in patients treated with two different strategies in acutely decompensated severe AS: bridged TAVI vs direct TAVI. Methods In this observational study all patients admitted with decompensated severe AS who underwent balloon aortic balloon valvuloplasty (BAV) and/or TAVI on the index admission were included. Comparison was made between bridged TAVI group (defined as initial BAV followed by TAVI) and direct TAVI group (TAVI on the index admission without bridging BAV). For this analysis we excluded patients in cardiogenic shock. Baseline characteristics, echocardiographic and periprocedural data were recorded in hospital database. Major adverse cardiovascular events (MACE) were defined as death, major bleeding, rehospitalisation for heart failure, or stroke). The follow-up data was obtained by outpatient visits and/or telephone calls. Results 178 patients with acutely decompensated AS were analysed: 58 bridged TAVI, 23 direct TAVI, 9 bridged SAVR and 88 destination BAV (defined as BAV non followed by a definite treatment). There was no statistically significant difference between bridged TAVI and direct TAVI group in mean age (83.6±6.6 vs 80.4±8.3 years), the prevalence major comorbidities (coronary, respiratory, neurological or peripheral vascular disease), renal function (eGFR 43.4±18.9 vs 45.2±20.9 ml/min/m2), the mean LV ejection fraction (53.4±13.8 vs 48.6±14.6%) or aortic valve gradient (39.4±13.0 vs 34.1±12.3mmHg), respectively. Direct TAVI patients had a higher mean surgical risk scores (STS 6.1±3.7 vs 9.1±7.0%, logES 18.8±11.5 vs 30.8±20.9%, p=0.01) and higher prevalence of significant aortic regurgitation (5% vs 43%, p=0.0001). The femoral TAVI access was used in 98% of bridged and 78% of direct TAVI patients (p=0.006). The estimated 1-year survival and 1-year MACE-free survival did not differ significantly between the bridged TAVI and direct TAVI groups (86.8% vs 78.3%, p=0.20 and 79.7% vs 64.2%, p=0.11, respectively). Conclusions A large proportion of patients admitted with acutely decompensated AS were not eligible for definite treatment. There is no difference in procedural success, 1-year all-cause mortality and 1-year major adverse cardiovascular events between the bridged TAVI or direct TAVI strategies in acute decompensated aortic stenosis allowing to personalize treatment strategy for individual patient. Funding Acknowledgement Type of funding sources: None. Table 1. Clinical and procedural data

Stroke Severity in Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement: A Systematic Review and Meta-Analysis

ObjectivesAn assessment of the comparative incidence of fatal or disabling stroke may influence choice of intervention for patients with severe aortic stenosis. We explored whether transcatheter aortic valve implantation (TAVI) is associated with a lower incidence of fatal or disabling stroke, compared to surgical aortic valve replacement (SAVR). Materials & MethodsWe classified stroke into two categories; fatal or disabling, or non-disabling, and completed meta-analyses for each. We explored randomised controlled trials to assess the effect publication year, predicted operative risk, and route of TAVI access. ResultsThere was no difference between treatment groups per 100 person years of follow up for disabling or non-disabling stroke outcomes. In a stratified analysis by year of publication, there was a lower rate of fatal or disabling stroke with TAVI in trials published after 2015, compared to those published in 2015 or before (p-interaction = 0.01 at 30 days). Higher proportions of transfemoral route access (>90%), more common in recent trials, were associated with a lower rate of fatal or disabling stroke (p-interaction = 0.03 at 30 days). Lower average surgical risk scores were associated with lower rates of fatal or disabling stroke (p = 0.02 at 30 days). ConclusionWe found that treatment of aortic stenosis with TAVI compared with SAVR was not associated with an overall reduced risk in fatal or disabling stroke. Subgroup analyses suggested a lower risk of fatal or disabling stroke with TAVI in situations which reflect contemporary practice.

A case report of a transcarotid transcatheter aortic valve implantation with concomitant carotid endarterectomy.

BackgroundTranscarotid transcatheter aortic valve implantation (TAVI) is a worthwhile substitute in patients who might otherwise be inoperable; however, it is applied in <10% of TAVI cases. In patients with established carotid artery stenosis, the risk of complications is increased with the transcarotid access route.Case summaryWe report a case of concomitant transcarotid TAVI and carotid endarterectomy (CEA) in a patient with bovine aortic arch and previous complex infrarenal EndoVascular Aortic Repair (EVAR). The integrity and positioning of the previous EVAR endograft was risked by transfemoral access. The right subclavian artery was only 4.5 mm and the left subclavian was totally occluded so transcarotid access was chosen. The patient recovered well, with no neurological deficit and was discharged home after 72 h. He was last seen and was doing well 6 months post-procedure.DiscussionIn patients with severe aortoiliac disease, or previous aortic endografting, transfemoral access for TAVI can be challenging or even prohibitive. Alternative access sites such as transapical or transaortic are associated with added risk because they carry increased risk of major adverse cardiovascular events, longer intensive care unit and hospital stay, and increased cost. A transcaval approach for TAVI has also been reported but was not suitable for our patient due to prior EVAR. Concomitant TAVI via transcarotid access and CEA can be successful in experienced hands. This case highlights the importance of a team-based approach to complex TAVI cases in high-risk patients with complex vascular access.

Transcarotid trancatheter aortic valve implantation under local anesthesia in real life, a retrospective observational comparison with femoral access

Abstract Background Trans-femoral approach is the most commonly used access for trans-catheter aortic valve implantation (TAVI). However, in case of unsuitability, several alterative access routes have been described, namely trans-axillary, trans-aortic and trans-apical. The trans-carotid approach, rarely used, can be of particular help. Purpose To compare trans-carotid with trans-femoral access for TAVI, regarding epidemiological, clinical, procedural features and in hospital prognosis. Methods We retrospectively analyzed the data of 1272 patients treated with TAVI between January 2013 and December 2019. Patients were divided into 2 groups and compared according to the vascular approach: trans-carotid group (n=84) and trans-femoral group (n=1188). Results The trans-carotid group, representing 6.6% of all patients undergoing TAVI, had significantly more hypertension (89.9% vs 75.8%; p=0.002), history of coronary artery disease (78.6% vs 50.5%; p&amp;lt;0.001), peripheral arteriopathy (58.7% vs 9.3%; p&amp;lt;0.0001), ischemic stroke (24% vs 10.5%; p=0.03), chronic obstructive pulmonary disease (30.8% vs 18.4%; p=0.004), surgical aortic valve replacement (12% vs 4.3%; p=0.008) and contralateral carotid endarterectomy (4% vs 0.4%; p=0.012). Average scores of LOGISTIC EUROSCORE and EUROSCORE II were significantly higher in this group (respectively 22.4 vs 15.2 and 8.3 vs 5.56; p&amp;lt;0.0001) and patients were more frequently considered by the Heart Team as at high surgical risk (91.3% vs 68.2%; p&amp;lt;0.0001). When performing TAVI, balloon predilatation and postdilatation were significantly less frequent in the trans-carotid group (respectively 13.3% vs 26.4%; p=0.03 and 21.7% vs 37.6%; p=0.006). However, there was no significant difference between the 2 groups concerning neither the implantation of self-expanding/balloon-expandable valves nor in the fluoroscopy time and dose-area product averages. On post-procedural echocardiographic findings, transaortic mean gradient average and the incidence of significant paravalvular leak were similar. During intra-hospital follow-up, patients in the trans-carotid group had significantly less vascular complications (9.3% vs 23%; p=0.02) and less urgent need of endovascular repair (0% vs 15.8%; p=0.013) without any impact on the need for transfusion. However, the incidence of atrial fibrillation was significantly higher (17.4% vs 9.4%; p=0.036). There was no significant difference between the two groups for the incidence of haemodynamic and neurological complications, high-degree atrioventricular block and in-hospital mortality. Conclusion According to our study, trans-carotid TAVI under local anesthesia can be feasible and safe, especially in more friable patients at higher risk. It was associated with lower incidence of vascular complications but a higher incidence of atrial fibrillation, without impact on in-hospital mortality. Randomized controlled trials are needed to establish a firm conclusion about this novel approach. Funding Acknowledgement Type of funding source: None

Meta-analysis Comparing Transradial Versus Transfemoral Secondary Access in Transcatheter Aortic Valve Implantation

Up to a quarter of vascular complications during transcatheter aortic valve implantation (TAVI) result from secondary access via the femoral artery (FA). The radial artery (RA) is increasingly used as an alternative to the FA for secondary access in TAVI. Limited data exist on the outcomes of RA secondary access versus FA secondary access. We therefore conducted a systematic review and meta-analysis comparing secondary access sites. PubMed, EMBASE, Scopus, Cochrane library and CINAHL were searched systematically for studies comparing RA and FA as secondary access sites for TAVI. Primary outcomes of interest were vascular complications and major bleeding. Secondary outcomes included all-cause mortality, stroke and myocardial infarction (MI). Risk ratio (RR), standardized mean difference and corresponding 95% confidence intervals (CI) were calculated using a random effects model. Six observational studies comprising 6,373 patients (RA: 1,514, FA: 4,859) met inclusion criteria. Secondary access was utilized for aortography during valve deployment and to manage primary access site complications. Procedural characteristics were similar in both groups. RA was associated with a lower risk of major bleeding (RR: 0.51, 95% CI: 0.40 to 0.64, p <0.00001). No statistically significant difference was observed in the incidence of overall vascular complications, however, the risk of major vascular complications was lower with RA (RR: 0.45, 95% CI: 0.32 to 0.63, p <0.00001). The incidence of stroke and all-cause mortality was lower in RA, whereas no difference was observed in the risk of MI. In conclusion, our meta-analysis suggests that RA secondary access is associated with better outcomes for TAVI than FA.

Anticoagulation with or without Clopidogrel after Transcatheter Aortic-Valve Implantation

BackgroundThe roles of anticoagulation alone or with an antiplatelet agent after transcatheter aortic-valve implantation (TAVI) have not been well studied.MethodsWe performed a randomized trial of clopidogrel in patients undergoing TAVI who were receiving oral anticoagulation for appropriate indications. Patients were assigned before TAVI in a 1:1 ratio not to receive clopidogrel or to receive clopidogrel for 3 months. The two primary outcomes were all bleeding and non–procedure-related bleeding over a period of 12 months. Procedure-related bleeding was defined as Bleeding Academic Research Consortium type 4 severe bleeding, and therefore most bleeding at the puncture site was counted as non–procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non–procedure-related bleeding, stroke, or myocardial infarction at 12 months (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2), both tested for noninferiority (noninferiority margin, 7.5 percentage points) and superiority.ResultsBleeding occurred in 34 of the 157 patients (21.7%) receiving oral anticoagulation alone and in 54 of the 156 (34.6%) receiving oral anticoagulation plus clopidogrel (risk ratio, 0.63; 95% confidence interval [CI], 0.43 to 0.90; P=0.01); most bleeding events were at the TAVI access site. Non–procedure-related bleeding occurred in 34 patients (21.7%) and in 53 (34.0%), respectively (risk ratio, 0.64; 95% CI, 0.44 to 0.92; P=0.02). Most bleeding occurred in the first month and was minor. A secondary composite 1 event occurred in 49 patients (31.2%) receiving oral anticoagulation alone and in 71 (45.5%) receiving oral anticoagulation plus clopidogrel (difference, −14.3 percentage points; 95% CI for noninferiority, −25.0 to −3.6; risk ratio, 0.69; 95% CI for superiority, 0.51 to 0.92). A secondary composite 2 event occurred in 21 patients (13.4%) and in 27 (17.3%), respectively (difference, −3.9 percentage points; 95% CI for noninferiority, −11.9 to 4.0; risk ratio, 0.77; 95% CI for superiority, 0.46 to 1.31).ConclusionsIn patients undergoing TAVI who were receiving oral anticoagulation, the incidence of serious bleeding over a period of 1 month or 1 year was lower with oral anticoagulation alone than with oral anticoagulation plus clopidogrel. (Funded by the Netherlands Organization for Health Research and Development; POPular TAVI EU Clinical Trials Register number, 2013-003125-28; ClinicalTrials.gov number, NCT02247128.)