Transfemoral Procedures Research Articles

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.

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<0.01) and were more often females (57% vs 33%, respectively; p<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<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<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<0.01 for both). Non-retrievable SEVs required less radiation (14±7 vs. 18±10 mins, respectively; p<0.01), but still markedly more than BEVs (p<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

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.

SURgical vs. PERcutaneous ACCESS in Transfemoral Transcatheter Aortic Valve Implantation (SU-PER-ACCESS Study).

Background: The transfemoral (TF) approach is the most common route in TAVI, but it is still associated with a risk of bleeding and vascular complications. The aim of this study was to compare the clinical outcomes between surgical cut-down (SC) and percutaneous (PC) approach. (2) Methods: Between January 2018 and June 2022, 774 patients underwent a transfemoral TAVI procedure. After propensity matching, 323 patients underwent TAVI in each group. (3) Results: In the matched population, 15 patients (4.6%) in the SC group vs. 34 patients in the PC group (11%) experienced minor vascular complications (p = 0.02), while no difference for major vascular complication (1.5% vs. 1.9%) were reported. The rate of minor bleeding events was higher in the percutaneous group (11% vs. 3.1%, p <.001). The SC group experienced a higher rate of non-vascular-related access complications (minor 8% vs. 1.2%; major 2.2% vs. 1.2%; p < 0.001). (4) Conclusions: SC for TF-TAVI did not alter the mortality rate at 30 days and was associated with reduced minor vascular complication and bleeding. PC showed a lower rate of non-vascular-related access complications and a lower length of stay. The specific approach should be tailored to the patient's clinical characteristics.

Comparing Obtura Vascular Closure Device to Manual Compression for Achieving Hemostasis After Percutaneous Transfemoral Procedures: A Randomized Study.

This trial was designed and aimed to compare safety and efficacy of Obtura™ vascular closure device (VCD) to manual compression (MC) among patients undergoing transfemoral catheterization. This prospective, randomized, controlled, multicenter trial of Obtura VCD against MC randomized patients in 1:1 (n=268; 134:134) ratio. Safety and efficacy were measured by primary endpoints (time to hemostasis [TTH] and deployment success) and secondary endpoints which included technical success, device-related adverse events, and time to ambulation (TTA). The procedural access using right femoral artery was performed in 95.52% of patients in Obtura VCD versus 96.27% in standard MC method, whereas 2.99% of patients in each group underwent left femoral access. Bilateral access was performed in 1.49% (n=2) versus 0.75% (n=1) in Obtura VCD versus MC, respectively. Both the technical success and deployment success were 100%. Patients in Obtura VCD group had shorter TTH (3.26±3.39 vs 23.95±8.24 minutes; p<0.0001) and TTA (155.44±125.32 vs 723.84±197.98 minutes; p<0.0001) than MC group. No access site complications (re-bleeding, infection, arteriovenous fistula, and transient access site nerve injury) were noted at 2-week, 1-month, and 3-month follow-ups. There were 4 (3%) and 6 (4.5%) cases of hematoma, respectively, in Obtura VCD versus MC and 1 case (0.7%) of post-procedural arterial pseudoaneurysm each in both the groups which were successfully resolved and patients were discharged with no further complications. Further follow-up was without any adverse events. The study demonstrated favorable safety and efficacy of Obtura™ VCD with a significantly short TTH and TTA compared to MC. In patients undergoing cardiac catheterization, vascular closure devices (VCDs) can achieve hemostasis faster after successful implantation of the device with fewer complications such as bleeding and ambulation can be achieved faster. In terms of effectiveness, Obtura VCD was found to be better than manual compression in achieving early hemostasis and higher technical and deployment success was accomplished. Obtura VCD does not require enlargement of the route through the tissues, uses the same existing arterial sheath as its conduit, and does not cause patients' access sites to feel uncomfortable while it is being deployed.

Passive Approximator Vascular Closure Device Use in Patients with Shallow Femoral Artery Depth Increases Puncture-site Complications in Neuroendovascular Treatment

Puncture-site complications in interventional radiology sometimes cause severe conditions. Vascular closure devices play an important role in preventing puncture-site complications. Vascular closure devices are divided into 2 types, the directly suturing or clipping type (active approximators) and adherent sealant types (passive approximators). However, which types of vascular closure device are the safest and most effective for achieving hemostasis remains unclear. We analyzed the efficacy of each type of vascular closure device and risk factors for puncture-site complications. This study investigated 327 consecutive cases of neuroendovascular surgery using a transfemoral procedure during a 2-year study period. Passive approximators (Angioseal [St Jude Medical, Saint Paul, MN] and Exoseal [Cordis Corporation, Miami, FL]) were mainly used in the first half and active approximators (Perclose [Abbot Vascular, Santa Clara, CA]) in the second. We compared groups and estimated risk factors for puncture-site complications. All procedures were successful. Comparing groups with and without puncture-site complications, use of passive approximators and ≥3 antithrombotic medications tended to be more frequent and distance from skin to femoral artery and body mass index tended to be lower in the group with complications without significance. The cutoff for femoral artery depth calculated from a receiver operating characteristic curve was 16.43 mm. Multivariate analysis revealed ≥3 antithrombotic medications (P= 0.002, OR 15.29, 95% CI 2.76-85.76) and passive approximator use in patients with femoral artery depth <16.43 mm (P < 0.001, OR 17.08, 95% CI 2.95-57.80) were significantly higher in the group with puncture-site complications. Passive approximator use in patients with shallow femoral artery depth increases puncture-site complications in neuroendovascular treatment.

104 Use of the eShunt Implant in Treatment of Aneurysmal Subarachnoid Hemorrhage Communicating Hydrocephalus

INTRODUCTION: Aneurysmal subarachnoid hemorrhage (aSAH) may cause communicating hydrocephalus and elevated intracranial pressure (ICP) not amenable to weaning of cerebrospinal fluid (CSF) external ventricular drainage (EVD), often requiring surgical ventriculoperitoneal shunting (VPS) with risk of hemorrhage and infection. METHODS: Patients having intractable elevated ICP with EVD clamping and favorable inferior petrosal sinus and bony anatomy were included. ICP was monitored before and after eShunt deployment for 36-48 hours. Primary endpoint was reached if ICP remained &lt;20 cmH2O enabling EVD removal. CT imaging of the brain was obtained immediately post-eShunt placement to evaluate eShunt placement and assess for any presence of new procedural hemorrhage. RESULTS: Seven out of eight patients (5 female; age 64 ± 12 years) underwent successful transfemoral transvenous eShunt procedure at 25.3 days (Range 14-38) post aSAH. Primary endpoint was achieved in all with EVD removal by 36-48 hours without procedural or delayed hemorrhage. Mean ICP rapidly decreased from 33.4 to 13 cmH2O at 1 hour (p &lt; 0.0001) and to 9 cmH2O (p &lt; 0.0001) at 36 hours post eShunt placement. CONCLUSIONS: These early encouraging results of the eShunt implant suggest clinical role and utility in the management of subarachnoid hemorrhage associated hydrocephalus possibly eschewing the need for VP shunt surgery and enabling minimally invasive CSF diversion in patients requiring dual anti-platelet or anticoagulant therapy.

A comparative study on the transbrachial and transfemoral approaches for the treatment of superior mesenteric artery lesions.

Superior Mesenteric Artery (SMA) lesions present a significant challenge in endovascular surgery. Both the transbrachial (TBA) and the transfemoral (TFA) approaches have been employed for the treatment of these lesions, but the comparative effectiveness of these methods remains unclear. A retrospective analysis was conducted on patients who underwent TBA and TFA at a tertiary center between June 2020 and February 2023. Key parameters including technical success, procedural details, and complication rates were examined. In a study of 99 patients, 66 underwent Transfemoral Approach (TFA) and 33 underwent Transbrachial Approach (TBA). No significant age or gender differences were noted between groups. TFA procedures were longer (90.0 vs 63.5 min, p = 0.002) and had higher fluoroscopy times (59.0 vs 43.0 min, p = 0.02) and selective SMA times (366.0 vs 245.0 min, p = 0.038) compared to TBA, especially with a smaller aortomesenteric angle (<90°). Technical success rates were high in both groups (TFA 97%, TBA 93.9%, p = 0.60). Complication rates were similar between groups, with no significant predictors for access site complications identified. Both the TBA and the TFA are effective for the treatment of SMA lesions, with TBA potentially offering advantages in terms of efficiency and patient recovery, particularly in cases with certain anatomy. No significant differences in complication rates were found between the two groups. Further research, including prospective randomized trials, is needed to confirm these findings.

Strategies to Minimize Access Site-related Complications in Patients Undergoing Transfemoral Artery Procedures with Large-bore Devices.

Large bore accesses refer to accesses with a diameter of 10 French or greater and are necessary for various medical devices, including those used in transcatheter aortic valve replacement, endovascular aneurysm repair stent-grafts, and percutaneous mechanical support devices. Notably, the utilization of these devices via femoral access is steadily increasing due to advancements in technology and implantation techniques, which are expanding the pool of patients suitable for percutaneous procedures. However, procedures involving large bore devices carry a high risk of bleeding and vascular complications (VCs), impacting both morbidity and long-term mortality. In this review article, we will first discuss the incidence, determinants, and prognostic impact of VCs in patients undergoing large bore access procedures. Subsequently, we will explore the strategies developed in recent years to minimize VCs, including techniques for optimizing vascular puncture through femoral cannulation, such as the use of echo-guided access cannulation and fluoroscopic guidance. Additionally, we will evaluate existing vascular closure devices designed for large bore devices. Finally, we will consider new pharmacological strategies aimed at reducing the risk of periprocedural access-related bleeding.

Choice of anesthesia technique is associated with earlier hospital discharge and reduced costs after transcatheter transfemoral aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) has become a viable alternative to palliation in patients with severe aortic stenosis. We compared general anesthesia to conscious sedation for TAVI procedures with respect to post operative morbidity, hospital length of stay, and financial burden. We conducted a retrospective review of prospectively collected data in patients undergoing transfemoral TAVI procedures from 2012 to 2017. Patients were matched based on age and sex and classed into either general anesthesia or conscious sedation groups respectively. Conscious sedation was provided with a dexmedetomidine infusion, and patients in general anesthesia group received a standard induction, tracheal intubation, and maintenance with sevoflurane. The hospital case costs were compared between the two groups before and after adjustment for inflation. We matched 124 pairs for a total of 248 patients. Both groups were similar with respect to demographic data, past medical history, medications, and intraoperative characteristics. There was no difference in postoperative morbidity and mortality between the two groups. The median hospital length of stay was 5 [interquartile range (IQR): 3, 10] and 7 (IQR: 4, 12) days, P=0.01, and after adjustment for inflation, the total hospital case costs were $48,984 (IQR: $44,802, $61,438) Canadian (CAD) vs. $55,333 (IQR: $46,832, $68,702) CAD, P=0.01, in the conscious sedation and general anesthesia groups, respectively. Advancements in TAVI technologies, conscious sedation and a collaborative, multidisciplinary team approach reduces overall length of hospital stay and procedure costs.

Impact of Access Site on Periprocedural Bleeding and Cerebral and Coronary Events in High-Bleeding-Risk Percutaneous Coronary Intervention: Findings from the RIVA-PCI Trial.

The preference for using transradial access (TRA) over transfemoral access (TFA) in patients requiring percutaneous coronary intervention (PCI) is based on evidence suggesting that TRA is associated with less bleeding and fewer vascular complications, shorter hospital stays, improved quality of life, and a potential beneficial effect on mortality. We have limited study data comparing the two access routes in a patient population with atrial fibrillation (AF) undergoing PCI, who have a particular increased risk of bleeding, while AF itself is associated with an increased risk of thromboembolism. Using data from the RIVA-PCI registry, which includes patients with AF undergoing PCI, we analyzed a high-bleeding-risk (HBR) cohort. These patients were predominantly on oral anticoagulants (OAC) for AF, and the PCI was performed via radial or femoral access. Endpoints examined were in-hospital bleeding (BARC 2-5), cerebral events (TIA, hemorrhagic or ischemic stroke) and coronary events (stent thrombosis and myocardial infarction). Out of 1636 patients, 854 (52.2%) underwent TFA, while 782 (47.8%) underwent the procedure via TRA, including nine patients with brachial artery puncture. The mean age was 75.5years. Groups were similar in terms of age, sex distribution, AF type, cardiovascular history, risk factors, and comorbidities, except for a higher incidence of previous bypass surgeries, heart failure, hyperlipidemia, and chronic kidney disease (CKD) with a glomerular filtration rate (GFR) < 60ml/min in the TFA group. No clinically relevant differences in antithrombotic therapy and combinations were present at the time of PCI. However, upon discharge, transradial PCI patients had a higher rate of triple therapy, while dual therapy was preferred after transfemoral procedures. Radial access was more frequently chosen for non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina pectoris (UAP) cases (NSTEMI 26.6% vs. 17.0%, p < 0.0001; UAP 21.5% vs. 14.5%, p < 0.001), while femoral access was more common for elective PCI (60.3% vs. 44.1%, p < 0.0001). No differences were observed for ST-segment elevation myocardial infarction (STEMI). Both groups had similar rates of cerebral events (TFA 0.2% vs. TRA 0.3%, p = 0.93), but the TFA group had a higher incidence of bleeding (BARC 2-5) (4.2% vs. 1.5%, p < 0.01), mainly driven by BARC 3 bleeding (1.5% vs. 0.4%, p < 0.05). No significant differences were found for stent thrombosis and myocardial infarction (TFA 0.2% vs. TRA 0.3%, p = 0.93; TFA 0.4% vs. TRA 0.1%, p = 0.36). In HBR patients with AF undergoing PCI for acute or chronic coronary syndrome, the use of TRA might be associated with a decrease in in-hospital bleeding, while not increasing the risk of embolic or ischemic events compared to femoral access. Further studies are required to confirm these preliminary findings.

Sheathless radial approach in contemporary coronary rotational atherectomy: data from two high-volume centers

Aim: To analyze the feasibility and procedural outcome of percutaneous coronary intervention (PCI) using rotational atherectomy (RA), performed via transradial sheathless guiding catheter, as compared to a standard radial and femoral vascular approach. Methods: All consecutive patients undergoing RA at two high-volume PCI centers from May 2011 to May 2023 were included. Comparisons were made between the two transradial approaches and between the three types of vascular access. Results: Two hundred twenty-three patients were enrolled. Baseline characteristics were similar, with the exception of gender. We observed, in percentages, fewer cases of failure for sheathless than standard transradial attempts (7.5% vs. 11.5%, respectively), whereas all trans-femoral attempts were successful. Transfemoral procedures were longer and more frequently performed under mechanical circulatory support. There was no difference in procedural success between the three vascular approaches. A trend towards a higher rate of vascular and bleeding complications was found in the femoral group. Conclusion: Sheathless transradial vascular access is a viable option when performing RA during complex PCI procedures, tending to result in fewer failures than the standard transradial approach and reduced bleeding and vascular complications compared to the femoral method.

Transradial versus transfemoral approach in cerebral angiography: A meta-analysis.

Cerebral angiography has two common access sites: Transradial approach and transfemoral approach. However, there's no definitive answer to which one is superior. Compare transradial approach and transfemoral approach for a cerebral angiography procedure. A systematic review of the literature of studies reporting both transradial approach and transfemoral approach results was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. PubMed, Cochrane Library, and Embase were queried. The meta-analysis examined 18 studies comprising 9388 patients undergoing cerebral angiography. Among the patients, 4598 underwent transradial approach (48.9%) and 4790 underwent transfemoral approach (51.1%). Our results revealed no statistical differences between the approaches regarding procedure success, crossover to transfemoral approach, procedure and fluoroscopy time between both approaches in cerebral angiography. Total, major, and minor complications comparisons were more favorable to transradial approach for this procedure. These findings suggest, despite the ultimate decision regarding the choice of access method might be influenced by the physician's experience and personal preference, the data distinctly lean toward transradial approach as the preferable option for cerebral angiography. The advantages of transradial approach, highlighted by its lower complication rates, especially major complications, suggest that its adoption could contribute to enhanced patient safety and procedural outcomes.

Surgical Versus Interventional Treatment of Major Access Site Complications During Transfemoral TAVI Procedures at a Large Volume Center.

Access-related vascular complications in transfemoral transcatheter aortic valve implantation (TAVI) can be treated endovascularly or surgically. The aim of this study was to evaluate the short- and long-term outcomes of endovascular treatment compared with surgical repair for access-related vascular complications. This retrospective study was performed from January 1, 2018, to December 31, 2020. All transfemorally treated TAVI patients in whom a surgical or endovascular treatment for an access site complication was needed were included. The primary outcome was the need for any related vascular re-operation. In total, 1219 transfemoral TAVI procedures were conducted during the study period. 19 patients suffered an access complication requiring endovascular treatment, while 54 patients required surgical repair. No differences were seen with regard to re-operations (endovascular 15.8% vs surgical 14.8%; p=0.919), wound infections (endovascular 0% vs surgical. 11.1%; p=0.129), and wound healing disorders (endovascular 15.8% vs surgical 29.6%; p=0.237). Patients undergoing endovascular treatment were discharged earlier (endovascular 11.2 vs surgical 14.9 days; p=0.028). After surgical repair, patients received significantly more blood transfusions than endovascularly treated patients (endovascular 1.00 vs surgical 3.1 red blood cell concentrate bags; p<0.001). No differences were found regarding the new onset of walking pain, rest pain, and ischemic ulcers during follow-up. In this retrospective cohort, endovascular treatment of access-related vascular complications of transfemoral TAVI procedures was safe and feasible. During the hospital stay, endovascularly treated patients received fewer blood transfusions and were discharged faster than surgically treated patients. No differences regarding clinical outcomes and re-intervention rates were seen during the follow-up. Given the in this retrospective study demonstrated safety and feasibility of endovascular treatment for major access-related vascular complications, along with the in-hospital benefits and absence of follow-up disadvantages compared to surgical treatment, endovascular treatment should be considered in cases of major access-related vascular complications in transfemoral TAVI patients.

Predictors of Transfemoral Access Site Complications in Neuroendovascular Procedures: A large Single-Center Cohort Study

ObjectiveThe transfemoral (TF) route has historically been the preferred access site for endovascular procedures. However, despite its widespread use, TF procedures may confer morbidity as a result of access site complications. The aim of this study is to provide the rate and predictors of TF access site complications for neuroendovascular procedures. MethodsThis is a single center retrospective study of TF neuroendovascular procedures performed between 2017 and 2022. The incidence of complications and associated risk factors were analyzed across a large cohort of patients. ResultsThe study comprised of 2043 patients undergoing transfemoral neuroendovascular procedures. The composite rate of access site complications was 8.6 % (n = 176). These complications were divided into groin hematoma formation (n = 118, 5.78 %), retroperitoneal hematoma (n = 14, 0.69 %), pseudoaneurysm formation (n = 40, 1.96 %), and femoral artery occlusion (n = 4, 0.19 %). The cross-over to trans radial access rate was 1.1 % (n = 22). On univariate analysis, increasing age (OR=1.0, p = 0.06) coronary artery disease (OR=1.7, p = 0.05) peripheral vascular disease (OR=1.9, p = 0.07), emergent mechanical thrombectomy procedures (OR=2.1, p < 0.001) and increasing sheath size (OR=1.3, p < 0.001) were associated with higher TF access site complications. On multivariate analysis, larger sheath size was an independent risk factor for TF access site complications (OR=1.8, p = 0.02). ConclusionSeveral pertinent factors contribute towards the incidence of TF access site complications. Factors associated with TF access site complications include patient demographics (older age) and clinical risk factors (vascular disease), as well as periprocedural factors (sheath size).

Vascular complications of ProGlide versus Prostar in transcatheter aortic valve replacement (TAVR) procedures: meta-analysis.

The aim of this study was to compare the vascular complications of ProGlide and Prostar in percutaneous transfemoral transcatheter aortic valve replacement. Electronic databases were searched in July 2022 for studies that compared the vascular complications of ProGlide and Prostar for percutaneous closure in transcatheter aortic valve replacement. The primary outcome was major vascular complications and the secondary outcomes were minor vascular complications, types of access-site vascular complications, device failure, and additional intervention. Estimates of relative effects were pooled to generate ORs and their 95 per cent c.i. using a random-effects model. The risk of bias in non-randomized comparative studies was assessed using the Risk Of Bias In Non-randomized Studies - of Interventions ('ROBINS-I') tool. Nine studies were identified and a total of 7529 patients were included. Among them, 4144 patients received ProGlide and 3385 received Prostar. The pooled data showed that the risk of major vascular complications was significantly lower with ProGlide versus Prostar (OR 0.50, 95 per cent c.i. 0.32 to 0.78). Regarding the types of vascular complications, vascular trauma was the most common complication and the risk was similar between groups (OR 1.02, 95 per cent c.i. 0.55 to 1.91). ProGlide had a lower risk of bleeding complications (OR 0.46, 95 per cent c.i. 0.22 to 0.94), but a higher risk of ischaemia complications (OR 1.90, 95 per cent c.i. 1.10 to 3.27). The risk of device failure was lower in the ProGlide group (OR 0.45, 95 per cent c.i. 0.21 to 0.95). Both groups had a similar risk of having additional interventions for vascular complications (OR 1.02, 95 per cent c.i. 0.75 to 1.39). The use of ProGlide was associated with a lower risk of additional surgical treatments (OR 0.52, 95 per cent c.i. 0.34 to 0.80), but a higher risk of endovascular treatments (OR 2.69, 95 per cent c.i. 1.29 to 5.63). In percutaneous transfemoral transcatheter aortic valve replacement procedures, ProGlide has superior safety and efficacy when compared with Prostar; it is associated with fewer major vascular complications and device failures. The vascular complications of ProGlide are more likely to be dealt with using endovascular treatments than surgical treatments.

Results and insights after 413 TAVI procedures performed by cardiac surgeons on their own.

Current evidence on transcatheter aortic valve implantation (TAVI) has been generated exclusively by cardiology studies and no operative data from cardiac surgeons are available. Here, we describe the development of our TAVI programme and report the results of transfemoral (TF) TAVI done by cardiac surgeons on their own. This study included all the TAVI procedures on native valve performed at Cardiac Surgery Unit, Ospedali Riuniti di Ancona, during the period October 2018 to July 2022. Relevant prospectively collected preoperative, intraprocedural and postoperative data were retrieved from the Institutional database. A total of 413 patients were included in the study. Mean patients' age was 82 years and among them 44% (180/413) were male. STS score was 3.1% (2.2-4.4). Eighty patients underwent transapical TAVI and 333 patients had a TF approach. We progressively moved from transapical TAVI towards TF procedures that are now routinely performed on conscious sedation and using a fully percutaneous approach. After TF TAVI, 30-day mortality rate was 1%, cerebral stroke occurred in 2% of the cases, permanent pacemaker implantation was necessary in 23% of the patients and in 6% of the cases there was a moderate/severe degree of aortic regurgitation. There was no association between operators performing TAVI and 30-day mortality. The acquisition of catheter-based skills and an adequate training allowed cardiac surgeons to perform on their own awake and fully percutaneous TF TAVI with similar results when compared with major randomized clinical trials and registries' experiences.

Novel computational protocol to support transfemoral prosthetic alignment procedure using machine learning techniques

BackgroundThe prosthetic alignment procedure considers biomechanical, anatomical and comfort characteristics of the amputee to achieve an acceptable gait. Prosthetic malalignment induces long-term disease. The assessment of alignment is highly variable and subjective to the experience of the prosthetist, so the use of machine learning could assist the prosthetist during the judgment of optimal alignment. Research objectiveTo assist the prosthetist during the assessment of prosthetic alignment using a new computational protocol based on machine learning. MethodsSixteen transfemoral amputees were recruited for training and validation of the alignment protocol. Four misalignments and one nominal alignment were performed. Eleven prosthetic limb ground reaction force parameters were recorded. A support vector machine with a Gaussian kernel radial basis function and a Bayesian regularization neural network were trained to predict the alignment condition, as well as the magnitude and angle of required to align the prosthesis correctly. The alignment protocol was validated by one junior and one senior prosthetist during the prosthetic alignment of two transfemoral amputees. ResultsThe support vector machine-based model detected the nominal alignment 92.6 % of the time. The neural network recovered 94.11 % of the angles needed to correct the prosthetic misalignment with a fitting error of 0.51°. During the validation of the alignment protocol, the computational models and the prosthetists agreed on the alignment assessment. The gait quality evaluated by the prosthetists reached a satisfaction level of 8/10 for the first amputee and 9.6/10 for the second amputee. ImportanceThe new computational prosthetic alignment protocol is a tool that helps the prosthetist during the prosthetic alignment procedure thereby decreasing the likelihood of gait deviations and musculoskeletal diseases associated with misalignments and consequently improving the amputees-prosthesis adherence.

Dedicated Next Day Discharge Post Minimalist TAVI: The Tasmanian Experience.

To assess the safety, feasibility and independent predictors of next day discharge (NDD) in patients undergoing minimalist transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) in a real-world Australian population. This single centre study reviewed 135 consecutive patients who underwent minimalist transfemoral TAVI from June 2020 to February 2022. Baseline demographics, procedural characteristic and outcomes were obtained. All patients were assessed by the local protocol for NDD. Patients were then divided into two groups: those who achieved next day discharge (NDD) and those requiring >1 overnight hospital stay. Univariate, bivariate and stepwise multivariate logistic regression modelling was used to identify the predictors of successful next day discharge. The mean age of the cohort was 82.9±5.7 years with 62.3% patients male, the average STS score was 4.1±2.4. All 135 patients underwent a successful transfemoral TAVI procedure, with 131 (97%) receiving a balloon-expandable valve. Ninety-seven (97) (71.9%) patients achieved NDD. Thirty (30)-day outcomes were excellent with a 30-day mortality of 0.7%, transient ischaemic attack/cardiovascular accident (TIA/CVA) 1.5%, major vascular complication 1.5% and 11.4% need for permanent pacemaker (PPM). In patients not achieving NDD, the average length of stay (LOS) was 3.0 days. Baseline characteristics demonstrated pre-existing first degree atrioventricular (AV) block and right bundle branch block (RBBB) as statistically significant negative predictors of NDD on univariate analysis. Next day discharge was achievable in only 50% of patients who suffered any minor or major procedural complication (15/30). Stepwise multivariate logistic regression modelling demonstrated female gender (OR 3.094, 95% CI 1.141-8.391, p=0.026), smaller aortic valve area (AVA) (OR 48.265, 95% CI 2.269-102.6, p=0.013), the presence of diabetes mellitus (OR 0.594, 95% CI 0.356-0.991, p=0.046) and a longer procedure time (OR 0.960, 95% CI 0.935-0.986, p=0.002) as statistically significant negative predictors of NDD. In addition, there was no difference in 30-day readmission rates between the NDD and non-NDD cohort (7.2% vs 10.5%, p=0.386). Next day discharge is safe and feasible in almost three quarters of patients undergoing minimalist TAVI for severe AS in a predominantly balloon expandable valve cohort, with a very low rate of 30-day readmission. NDD provides advantages for hospital efficiency and improved cost-effectiveness. Female gender, smaller AVA, the presence of diabetes mellitus and a longer procedure time were independent negative predictors of successful NDD.

Clinical evaluation of a new technique for custom-made spacers in septic two-stage revision of total hip arthroplasties.

In septic two-stage revision surgery, success depends on numerous factors. Key steps are the procedure of ex- and reimplantation and the choice of spacer in the interim phase. The latter is still a matter of debate. Recently, we showed the microbial non-inferiority of a spacer technique using prosthetic cemented implants with an individualized antibiotic mixture in the cement applying a mechanically inferior cementation method. The aim of the present study was to evaluate the clinical results of these spacers in view of either an endofemoral or a transfemoral procedure. Our collective consisted of 86 patients (45 endofemoral and 41 transfemoral procedures). The collective was analyzed with respect to complications, reinfection rate and clinical status at the end of the interim phase. Results of an endofemoral and transfemoral approach were compared. With a median Staffelstein-Score of 60 (range 31-81) at the end of the interim phase, the first clinical results are promising. The reinfection-free rate after a median follow-up of 50months was 90%. Spacer-related complications occurred in 8% of the total collective. Comparing the endo- and transfemoral procedure, there were no statistical differences in complications or regarding the clinical and infectiological outcome. In this study, we were able to show good clinical results for the presented spacer technique. With no relevant difference in outcome, the decision for an endofemoral or transfemoral technique can be based on technical deliberations. Further prospective comparative studies are necessary to show the clinical benefit of this procedure.