Transcatheter edge-to-edge repair (TEER) has become the most common percutaneous technique for patients affected by severe regurgitation, either mitral or tricuspid, as recommended by the latest European and American guidelines on valvular heart disease. Among the available devices, the PASCAL Precision system (Edwards Lifesciences, Irvine, California) is the latest technology introduced on the market, with a CE Mark obtained in 2019 for MR and in 2020 for TR treatment. Several studies have demonstrated its safety and effectiveness in both the treatment of MR and TR, but optimal TEER results are closely connected to the operator's experience. In this perspective, the aim of the present manuscript is to provide a full guide on basic and advanced movements of the PASCAL system for the treatment of MR and TR.
BACKGROUND:Recent studies have questioned whether iodinated contrast is causally related to acute kidney injury (AKI). AIM:We pursed a contemporary analysis to determine the impact of contrast dose on AKI following coronary procedures in an era of lower contrast doses and less nephrotoxic agents. METHODS:This national cohort study examined patients who had percutaneous coronary intervention (PCI) or diagnostic angiography from October 2010 to May 2023. We used logistic regression to test associations between (1) baseline (pre-procedural) AKI risk and contrast dose, and (2) contrast dose and post-procedure AKI. Contrast exposure was quantified as a proportion of the maximal allowable contrast dose (MACD; 2.5 mL × body weight (kg)/serum creatinine). RESULTS:Median contrast volume decreased during our study period for PCI (200 to 150 mL, p < 0.01) and angiography (95 to 60 mL, p < 0.01). In the combined cohort of 175,963 procedures, the mean patient age was 68.5 years; 97.5% were male. Decile plots revealed that patients at higher baseline risk of AKI received lower contrast volumes. When the contrast dose exceeded MACD, there was a stepwise association between contrast dose and adjusted odds of AKI. The highest odds of AKI were observed for patients with eGFR < 30 who received > 200% of the MACD (OR, 2.89; 95% CI, 2.21 to 3.79). CONCLUSIONS:In this large national cohort of patients undergoing coronary procedures, there was a reduction in contrast dose over time and evidence that physicians are reducing contrast volume for high-risk patients. The MACD remains a reasonable target to reduce AKI.
BACKGROUND:New-onset atrial fibrillation (NOAF) is a frequent complication after transcatheter aortic valve implantation (TAVI) and is associated with adverse outcomes, yet simple pre-procedural tools to identify at-risk patients are limited. The HATCH score predicts incident atrial fibrillation in other settings but has not been evaluated in TAVI. We assessed whether the HATCH score predicts NOAF after transfemoral TAVI and compared it with the CHA2DS2-VASc score. METHODS:In this retrospective single-center study, 268 patients in sinus rhythm who underwent transfemoral TAVI for severe aortic stenosis between October 2022 and January 2026 were included. NOAF was defined as atrial fibrillation or flutter lasting ≥ 30 s during the index hospitalization. Independent predictors were identified by multivariable logistic regression; discrimination was assessed by the area under the receiver operating characteristic curve (AUC), compared using the DeLong test, and internally validated by bootstrapping. RESULTS:NOAF occurred in 44 patients (16.4%). The HATCH score was higher in the NOAF group (2.75 ± 0.81 vs. 2.03 ± 0.85; p < 0.001). On multivariable analysis, the HATCH score (adjusted odds ratio [OR] 2.69, 95% CI 1.75-4.13; p < 0.001) and aortic root angulation (adjusted OR 1.05 per degree, 95% CI 1.02-1.09; p = 0.002) were independent predictors of NOAF. The HATCH score yielded an AUC of 0.730 (95% CI 0.672-0.782), numerically higher than that of the CHA2DS2-VASc score (0.668, 95% CI 0.608-0.724), although the difference was not significant (p = 0.216); a HATCH score ≥ 3 provided 63.6% sensitivity and 77.7% specificity. The optimism-corrected C-statistic was 0.761 with a calibration slope of 0.918. NOAF was associated with a higher rate of in-hospital stroke (15.9% vs. 3.6%; p = 0.005). CONCLUSIONS:The HATCH score independently predicted NOAF after transfemoral TAVI and performed at least as well as the CHA2DS2-VASc score; aortic root angulation was an additional independent correlate. As a simple, bedside tool, the HATCH score may aid pre-procedural risk stratification, pending external validation.
Hemophilia A combined with acute myocardial infarction (AMI) is rare and challenging to treat. This article reports a 65-year-old patient with hemophilia A admitted for acute inferior ST-segment elevation myocardial infarction, who successfully underwent emergency drug-coated balloon (DCB) angioplasty with factor VIII replacement support. Dual antiplatelet therapy (DAPT) was discontinued 3 weeks after the operation, after which the patient received neither antithrombotic therapy nor replacement therapy, while comprehensive risk factor control was intensified. No recurrent thrombotic or hemorrhagic events were observed during the 1-year follow-up. This case suggests that the DCB strategy can shorten the required duration of antithrombotic treatment, and discontinuing antithrombotic and replacement therapies may be safe for selected patients, with comprehensive risk factor control serving as the core antithrombotic intervention at this stage.
Directional coronary atherectomy (DCA) requires precise spatial orientation. Although the tip detection method is established for intravascular ultrasound, its application in optical coherence tomography (OCT)-guided DCA remains unestablished. We present a case of functionally significant stenosis at the left anterior descending (LAD) artery ostium treated with OCT-guided DCA. We adapted the tip detection method using a second guidewire with a tip curve. Aligning the fluoroscopically directed guidewire with the 3 o'clock position on the OCT cross-section achieved precise three-dimensional spatial co-registration, enabling accurate plaque localization. This first report demonstrates that OCT-guided tip detection offers a safe and sophisticated debulking strategy for complex coronary lesions.
Membranous ventricular septal aneurysm (MSA) is an uncommon anatomical finding that may significantly alter the geometry of the aortic annulus and left ventricular outflow tract, creating challenges for transcatheter aortic valve replacement (TAVR). We report the case of a 78-year-old woman with symptomatic severe bicuspid aortic stenosis and a large MSA who underwent successful TAVR following CT-guided procedural planning. Cardiac computed tomography demonstrated interruption of annular continuity by the aneurysmal cavity, making conventional annular sizing unreliable. A virtual annular plane excluding the aneurysm was reconstructed to estimate the effective landing zone, yielding an annular area of 387 mm2 and a perimeter of 71.4 mm. Given the large aneurysmal neck and bicuspid valve with a calcified raphe, a 29-mm Evolut FX+ self-expanding valve was selected. Following balloon valvuloplasty, valve implantation was successfully performed with excellent positioning and minimal residual aortic regurgitation. At 2-month follow-up, the patient reported marked symptomatic improvement. Cardiac CT demonstrated stable prosthesis positioning, absence of leaflet thrombosis, and reduction of MSA systolic volume from 2.81 cm3 to 1.55 cm3. This case highlights the importance of multimodality imaging, CT-based virtual annular reconstruction, and individualized valve selection in patients with complex structural anatomy undergoing TAVR.
BACKGROUND:Transcatheter closure (TCC) of sinus venosus defects (SVD) using balloon-expandable covered stents is an emerging alternative to surgery. ZephyrCS (Sahajanand Laser Technologies, Gandhinagar, India) is available in long lengths to suit SVD closure. A recent hybrid design with a short uncovered end intends to prevent left innominate vein and additional high-draining pulmonary vein occlusion. AIMS:Study the procedural success, serious adverse events, stent performance parameters and need for reintervention after SVD closure. METHODS:This retrospective, single-center observational study analysed all consecutive SVD closures using ZephyrCS between January 2022 and December 2025. RESULTS:TCC was attempted in 100 patients with a median age of 33 years (4-73 years). Availability of long stents allowed a single-stent strategy (hybrid in 14) in 79% and elective overlapping stents only in 21%. 79 mm stent length was more frequently used. Additional stents to bail-out embolization, caudal migration, and fabric leak were required in 22%. Median stent shortening was 9%, and recoil was negligible (median 2%). Procedural success was 98%; two embolizations required surgery. 73.5% had no residual shunt at 1-year transesophageal echocardiography. At a median follow-up of 21 months (2-41 months), residual leak warranted two reinterventions. Asymptomatic intraluminal stent thrombosis was noted in 10.2%, and minor insignificant fabric leak in 11.2%. CONCLUSIONS:ZephyrCS is safe, feasible, and effective for SVD closure, with acceptable mid-term outcomes. Long stents and hybrid design are useful for most anatomic variations. Even though minor fabric leak and intraluminal stent thrombus were not clinically significant, they need to be addressed.
The BATMAN (Balloon-Assisted Translocation of the Mitral Anterior leaflet) technique, a novel approach for modifying the anterior leaflet during transcatheter mitral valve replacement (TMVR), has recently demonstrated efficacy in preventing left ventricular outflow tract obstruction (LVOT) which constitutes a high-risk complication in valve-in-valve TMVR procedures. We describe three complex cases of severe bioprosthetic mitral stenosis who underwent successful valve-in-valve TMVR utilizing a modified transseptal BATMAN technique. We highlight the procedural methodology and explore the potential for this technique to be standard of care for valve-in-valve TMVR.
Coronary obstruction (CO) represents a rare yet critical complication following transcatheter aortic valve replacement (TAVR), characterized by significant mortality and morbidity. Computed tomography plays a pivotal role in the pre-procedural assessment and prediction of this risk. While various techniques have been devised to mitigate the occurrence of CO, management of such complications remains challenging with few available treatment options. Herein, we present a case involving left main CO that was successfully managed through retrograde angioplasty and stenting utilizing a saphenous venous graft.
BACKGROUND:Transcatheter aortic valve implantation (TAVI) with the Acurate Neo has been linked to a significant incidence of paravalvular leakage (PVL), addressed by the Acurate Neo 2 incorporating an active sealing skirt. Recent findings suggest that midframe under-expansion is associated with worse outcomes. AIMS:We investigated the hemodynamic and clinical outcomes after TAVI with Acurate Neo 2 compared to Acurate Neo and assessed the impact of midframe under-expansion. METHODS:Patients who received Acurate Neo (n = 124) or Acurate Neo 2 (n = 133) between February 2018 and December 2021 (switch to Acurate Neo 2 in November 2020) were included. The primary outcomes were VARC-3 defined device success and early safety. RESULTS:Device success was higher with Acurate Neo 2 compared with Acurate Neo (94.7% vs. 86.3%, p = 0.020), as was early safety (87.2% vs. 74.2%, p = 0.008). The rate of mild/moderate PVL was significantly lower in Acurate Neo 2. Kaplan-Meier estimated 1-year survival (Acurate Neo 2: 87.8% vs. Acurate Neo: 89.0, p = 0.930) and freedom from the combined clinical endpoint death, stroke, myocardial infarction, and heart failure rehospitalization at 1 year (Acurate Neo 2: 81.2% vs. Acurate Neo: 79.3%, p = 0.528) were comparable between groups. A long-term analysis of these endpoints revealed no difference between groups. Midframe under-expansion occurred in 13.3% and was associated with lower freedom from the combined clinical endpoint at 1 year, irrespective of prosthesis generation. CONCLUSION:Acurate Neo 2 demonstrated significant improvements in device success and early safety compared to Acurate Neo. Midframe under-expansion occurred with both generations and was associated with worse clinical outcomes within the first year.
BACKGROUND:Percutaneous closure of femoral arterial access is a critical step in transcatheter aortic valve implantation (TAVI). A hybrid strategy combining a suture-based device (Perclose ProStyle) and a collagen-based device (Angio-Seal) has emerged as an alternative to the conventional double Perclose ProStyle technique. AIMS:The objective of the study is to compare femoral vascular complications between a hybrid strategy (1 Perclose ProStyle+ 1 Angio-Seal) and a non-hybrid strategy (2 Perclose ProStyle) in a large single-center experience. METHODS:This prospective, single-center, non-randomized study included 633 consecutive patients who underwent transfemoral TAVI at Timone University Hospital (Marseille, France) between November 2024 and March 2026. The choice of closure strategy was left to the operator's discretion. The primary endpoint was the occurrence of any femoral vascular complication (classified according to VARC-3 criteria). RESULTS:A total of 273 patients underwent hybrid closure, and 360 underwent non-hybrid closure. The overall rate of vascular complications was 4.9% (31/633), with no significant difference between groups (hybrid 4.8% vs. non-hybrid 5.0%; p = 1.000). There were no differences in major VARC-3 complications (2.2% vs. 1.9%, p = 1.000) or minor complications (2.6% vs. 3.1%, p = 0.899). In univariate analysis, preprocedural dual antiplatelet therapy was the main predictor of overall complications, hematoma, pseudoaneurysm, and minor VARC-3 complications. Dialysis was associated with major VARC-3 complications. CONCLUSION:The hybrid closure strategy (1 Perclose ProStyle + 1 Angio-Seal) demonstrates a vascular safety profile comparable to the conventional strategy (2 Perclose ProStyle) in transfemoral TAVI. Preprocedural antithrombotic therapy, rather than the closure device strategy, appears to be the main determinant of vascular complications.
BACKGROUND:The expanding utilization of extraplaque (EP) strategies has led to increasing success rates in coronary chronic total occlusion (CTO) recanalization. The contemporary EP techniques have shown mid-term outcomes comparable to intraplaque (IP) recanalization approaches. Differential neointimal healing after CTO recanalization by various approaches remains to be identified. AIM:This study aimed to assess the vascular healing response across different CTO recanalization techniques using optical coherence tomography (OCT)-derived Neointimal Healing Score (NIHS). METHODS:This was a prospective, observational, analytic, single-center study recruiting 50 consecutive patients who underwent successful recanalization of 51 coronary CTOs. The recanalization technique (EP vs. IP) was according to the operator's discretion based on the CTO anatomical characteristics. The study aimed to compare the impact of the EP versus IP recanalization technique on the vascular healing assessed by OCT-derived NIHS (evaluating the presence of uncovered and/or malapposed stent struts and intraluminal filling defects), 6 months after the index procedure. RESULTS:The mean age was 58 ± 8 years, and 35 (70%) were males. EP and IP techniques were used in 15 and 36 of the recanalized CTOs, respectively. At 6 months, clinical and angiographic follow-ups were completed for all patients, while interpretable OCT imaging was available for 39 patients (77%). The mean NIHS for all patients was 14.3 ± 9.7. The NIHS was comparable between EP and IP techniques (18 ± 7.4 vs. 14.1 ± 8.4; p = 0.51). Target vessel failure (TVF) occurred in 23.5% of all patients with a numerically nonsignificant higher rate in the EP compared to the IP technique (27% vs. 22%; p = 0.73). CONCLUSION:CTO recanalization using EP techniques is associated with a nonsignificant numerical increase in NIHS without leading to a significant difference in TVF compared to IP techniques at mid-term follow-up.
BACKGROUND:Percutaneous patent foramen ovale (PFO) closure is established for selected patients with PFO-associated cryptogenic stroke and other dedicated indications; however, long-term outcome data remain limited. AIMS:Evaluate procedural, echocardiographic, and long-term clinical outcomes after percutaneous PFO closure. METHODS:Consecutive patients undergoing PFO closure at Heart Center Lucerne between February 2017 and December 2024 were analyzed. The primary endpoint was a combined endpoint of recurrent cerebrovascular events and death. Follow-up included 6-month echocardiography and clinical follow-up up to 8 years using electronic health records and structured telephone interviews. RESULTS:A total of 331 patients (mean age 51 ± 12 years, 39% women, 80% prior cryptogenic stroke) were analyzed. Atrial septal aneurysm was present in 31%, grade 3 shunt in 72%, and the median RoPE score was 7 (IQR 6-7). Technical success was 99%. Devices used were Amplatzer (52%), Figulla Flex (42%), NobleStitch (6%), and Gore (1%). Double-disc devices achieved higher effective closure (residual shunt ≤ grade 1) than suture-based closure (97% vs. 68%; p < 0.001); a double-disc closure for relevant residual shunt was required after 7/21 suture-based closures. During a median follow-up of 3.7 years (IQR 2.1-5.7) 12 patients had a primary outcome (three ischemic strokes, two hemorrhagic strokes, five transient-ischemic-attacks, and two deaths). The primary outcome rate was 0.93/100 patient-years and stroke recurrence rate was 0.39 per 100 patient-years. Residual shunt grade ≥ 2 showed a trend toward increased cerebrovascular risk (HR 4.3, 95% CI 0.9-20.9; p = 0.068). Atrial fibrillation was documented in 5.4% of patients during long-term follow-up. CONCLUSIONS:Percutaneous PFO closure showed high technical success and low long-term ischemic stroke recurrence. Double-disc devices provided higher effective closure than suture-based closure, and residual shunt may indicate increased cerebrovascular risk. A considerable proportion of patients developed atrial fibrillation following PFO closure.
BACKGROUND:Limited data are available on the use of intravascular ultrasound (IVUS) in patients presenting with ST-segment elevation myocardial infarction (STEMI). AIMS:This study aimed to assess the impact of IVUS-guided primary percutaneous coronary intervention (PCI). METHODS:SPECTRUM (NCT05007535) was a prospective, single-center, observational cohort study. STEMI patients presenting within 12 h after symptom onset with stable hemodynamics and undergoing primary PCI of a native culprit lesion (angiographic reference diameter ≥ 2.25 mm) were eligible. Pre-intervention, post-intervention and post-optimization (if applicable) HD-IVUS pullbacks were obtained per protocol. The primary endpoint was target vessel failure (TVF) at 12 months, a composite of cardiovascular death, target vessel myocardial infarction, and target vessel revascularization. The secondary endpoint was presence of IVUS-guided optimization. RESULTS:A total of 200 STEMI patients were included. Mean age was 62.1 (±12.5) years, 69% were male, 11.0% had diabetes and the left anterior descending was the culprit vessel in 44.0%. IVUS-guided optimization was performed in 41.1%. Optimal PCI, based on predefined IVUS criteria, increased from 52.1% post intervention to 65.5% post optimization (p < 0.001). A stent-edge plaque burden > 50% was the main reason for not achieving optimal PCI results after IVUS-guided optimization (94.4%). TVF at 12 months occurred in 3.0% (95% CI 1.1%-6.4%). CONCLUSIONS:SPECTRUM is the first dedicated prospective study demonstrating the potential of IVUS to optimize outcomes in a primary PCI setting. IVUS guidance in primary PCI was safe, significantly increased the number of STEMI patients with an optimal PCI result and resulted in low rates of TVF at 12 months.
BACKGROUND:Despite recommendations in international guidelines, Intracoronary pressure wire assessment (PWA) utilization remains limited in clinical practice. This study aims to describe (i) trends of PWA during Percutaneous coronary interventional (PCI), (ii) factors that predict its application, and (iii) association with in-hospital outcomes. METHODS:Adults with PCI for chronic coronary syndrome or Non-ST-elevation acute coronary syndrome in the British Cardiovascular Intervention Society (BCIS) database from January 2012 to March 2020 were included. Adjusted odds ratios (aOR) of PWA predictors and its association with in-hospital major adverse cardiovascular and cerebrovascular events (MACCE; a composite of total mortality, stroke/transient ischaemic attack, and new/reinfarction) were assessed using logistic regression models. RESULTS:303,453 records identified of which 10.74% had PWA. There was a modest rise in the use of PWA from 9.1% in 2012 to peak just over 13% in 2018. Intracoronary imaging (aOR: 1.23, 95% CI: 1.18-1.27, p < 0.001), and previous PCI (aOR: 1.30, 95% CI: 1.26-1.34, p < 0.001) were positive predictors of PWA. MACCE was lower with PWA (aOR: 0.73, 95% CI: 0.62-0.87, p < 0.001) in the overall population. PWA was associated with lower procedural complications (aOR: 0.90, 95% CI: 0.84-0.96, P: 0.001). CONCLUSION:PWA remains underutilized in UK real world practice. Among patients undergoing PCI, PWA was associated with lower in-hospital procedural complications and MACCE. It's association with in-hospital MACCE should be viewed as a hypothesis-generating for future studies. Using pressure wire as a performance and a quality metric for PCI might help improve adoption in the future.
INTRODUCTION:The prevalence of bioprosthetic aortic valve failure is increasing due to the broader use of bioprosthetic valves, both surgical and transcatheter, and an ageing population. Registry data indicate a higher risk of coronary obstruction and elevated gradients following valve-in-valve transcatheter aortic valve implantation (TAVI). We report outcomes of the Allegra transcatheter heart valve system in valve-in-valve TAVI. METHODS:In this retrospective multicentre cohort study, all patients undergoing valve-in-valve TAVI with the Allegra system between 2019 and 2025 at five UK centers were included. The combined primary outcomes were technical success, device success, and early safety at 30 days, as per the VARC-3 (Valve Academic Research Consortium-3) criteria. A key secondary outcome was all-cause mortality at the longest documented follow-up. RESULTS:A total of 106 patients underwent valve-in-valve TAVI. The mean age was 79 ± 6 years, with 57.5% being female. Almost half of the patients had an index valve ≤ 21 mm, with an STS (Society of Thoracic Surgery) score of 7.1% (5.1-12.0). The post-implant aortic valve mean pressure gradient was 12 ± 6 mmHg, and the mean valve area was 1.7 ± 0.5 cm2. The combined primary outcomes were technical success of 86.8% (CI 80.3%-93.2%), device success of 75.5% (CI 67.3%-83.7%), and early safety of 86.8% (CI 80.3%-93.2%). All-cause mortality at 30 days was 0%. All-cause mortality occurred in 6.6% at a median follow-up of 15 months. CONCLUSIONS:The Allegra TAVI system demonstrates promising technical and device success rates, with early safety and good post-implant haemodynamic performance in high-risk patients undergoing valve-in-valve TAVI. Larger randomized trials are needed to confirm these results.
BACKGROUND:Optimal stent expansion is a key determinant of long-term outcomes after PCI. Intravascular imaging provides the most accurate assessment of stent deployment but remains underused, especially in older patients with MI and multivessel disease. ESV is an angiographic enhancement technology that may help detect gross stent underexpansion when advanced imaging is not feasible. AIMS:To evaluate the procedural and clinical impact of enhanced stent visualization (ESV)-guided percutaneous coronary intervention (PCI) in older patients with myocardial infarction (MI) and multivessel disease. METHODS:In this prespecified sub-study of the FIRE trial, we evaluated the impact of ESV use during PCI in older MI patients. Among 1445 enrolled patients, 331 underwent ESV-guided PCI and 1114 standard angiography-guided PCI. Procedural optimization triggered by ESV was defined as additional postdilation, extra stent implantation, or use of intravascular imaging. Minimal lumen diameter (MLD) was assessed before and after ESV-guided optimization. Clinical outcomes were compared using multivariable and competing-risk adjusted Cox models. RESULTS:Operator-driven optimization occurred in 85% of ESV cases, primarily through postdilation (96%). ESV guidance resulted in a significant MLD increase from 2.51 [2.22-2.87] to 2.93 [2.41-3.32] mm (p < 0.001), yielding an acute luminal gain of 0.42 mm (95% CI 0.37-0.47). At 3 years, the composite primary endpoint (death, MI, stroke, or ischemia-driven revascularization) was lower in the ESV group (adjusted HR 0.70, 95% CI 0.54-0.91; p = 0.008). CONCLUSIONS:In older MI patients with complex multivessel disease, ESV-guided PCI was associated with greater procedural optimization, improved acute stent expansion, and lower long-term adverse events. While not a substitute for intracoronary imaging, ESV represents a pragmatic and valuable adjunct to enhance PCI quality in settings where intravascular imaging is seldom performed. TRIAL REGISTRATION:ClinicalTrials.gov identifier NCT03772743.
BACKGROUND:CTO PCI success depends on consistent equipment performance. Equipment friction (Stingray guidewire lumen fatigue, microcatheter internal lumen friction, and retrograde externalization friction) causes procedural delay and failure. The standard solution is device exchange, which is time-consuming and adds cost. To our knowledge, no published technique addresses CTO-specific equipment friction with an alternative to Rotaglide, which is unavailable in most countries. AIMS:This report aims to describe and illustrate the Propoglide technique, the use of propofol 1% lipid emulsion as an off-label lubricant to overcome equipment friction in CTO PCI across three clinically distinct scenarios. METHODS:We describe the Propoglide technique: propofol 1% lipid emulsion (soybean oil carrier) applied as an off-label lubricant across three CTO PCI scenarios: (A) Stingray balloon guidewire lumen, (B) microcatheter inner lumen, and (C) retrograde externalization. Device-specific dead space estimates for common coronary microcatheters guide propofol volume selection. Three illustrative cases demonstrate clinical application. RESULTS:Propofol lubrication resolved friction-related failure in all illustrated cases, restoring device function within a single application without device exchange. Propofol volumes ranged from 0.3 to 0.8 mL (3-8 mg), pharmacologically negligible relative to sedation doses. No adverse events were observed in the illustrative cases. CONCLUSIONS:Propofol 1% emulsion provides practical, safe lubrication for CTO PCI equipment across three clinically distinct friction scenarios, with particular relevance in settings where dedicated lubricants and externalization wires are unavailable. Prospective validation is warranted.
BACKGROUND:Vascular access site complications (VASCs) remain an important source of morbidity following percutaneous interventions. Although the sheath-to-femoral artery ratio is a recognized risk factor in transcatheter aortic valve implantation (TAVI), its role across a broader range of femoral procedures is less well defined. OBJECTIVE:To evaluate the association between the sheath‑to‑artery diameter (SHAD) ratio and early VASCs in patients undergoing femoral percutaneous interventions with sheaths > 6 Fr. METHODS:A nested case-control study was performed within a retrospective cohort of 2660 consecutive patients. A total of 177 patients who developed VASCs within 7 days were identified and compared with 353 propensity score-matched controls without complications. The propensity score included age, sex, body mass index, hypertension, diabetes mellitus, peripheral artery disease, and prior femoral access. The SHAD ratio was calculated using pre‑procedural computed tomography angiography (CTA). Inter‑observer agreement for arterial diameter was excellent (intraclass correlation coefficient 0.94). Receiver operating characteristic analysis identified the optimal cutoff (Youden index), and multivariable logistic regression with backward stepwise selection was internally validated by bootstrap. Anatomical factors (calcification, tortuosity) were examined as potential confounders. RESULTS:After matching, all baseline characteristics were well balanced (standardized differences < 0.10). The SHAD ratio was significantly higher in patients with VASCs than in controls (1.26 vs. 0.75; p < 0.001). A SHAD ratio ≥ 1.07 optimally predicted complications (AUC 0.83, 95% CI 0.80-0.87; sensitivity 82%; specificity 78%). In the final multivariable model, SHAD ≥ 1.07 remained the strongest independent predictor (OR 6.71, 95% CI 3.87-11.64; p < 0.001). Dual femoral access (OR 2.95, 95% CI 1.65-5.28) and procedural urgency (OR 1.98, 95% CI 1.18-3.32) also increased risk. Ultrasound‑guided puncture (OR 0.15, 95% CI 0.08-0.28) and fluoroscopy‑guided access (OR 0.14, 95% CI 0.07-0.26) were strongly protective. Anterior wall calcification was associated with a higher complication risk in univariable analysis but did not remain significant after adjustment for SHAD. Bootstrap internal validation yielded an optimism‑corrected AUC of 0.91 (95% CI 0.89-0.93), indicating good discrimination. CONCLUSIONS:A SHAD ratio ≥ 1.07 is a robust predictor of early VASCs across multiple large‑bore femoral interventions. Maintaining a sheath‑to‑artery relationship ≤ 1.0, together with image‑guided access, may substantially reduce complications. The incorporation of SHAD assessment into pre‑procedural planning is supported, pending external validation.
