Calcified Common Femoral Artery Research Articles

Intravascular Lithotripsy for Treatment of Severely Calcified Common Femoral Artery Disease: Results From the Disrupt PAD III Observational Study.

Surgical endarterectomy is currently considered the front-line therapy for the treatment of calcified lesions in the common femoral artery (CFA). Endovascular interventions have evolved, and their use is increasing in frequency. Intravascular lithotripsy (IVL) has shown promising safety and effectiveness in calcified CFA lesions in a small pilot study, but "real-world" evidence from a larger cohort is lacking. The Disrupt PAD III Observational Study (NCT02923193) was a prospective, multicenter registry designed to assess the acute safety and effectiveness of IVL treatment for calcified peripheral arterial disease. Any concomitant treatment with other calcium-modifying technologies as well as definitive treatment strategies was at the discretion of the operators. Patients with CFA lesions were evaluated for acute angiographic safety and effectiveness outcomes following IVL treatment as determined by an independent angiographic core lab. Common femoral artery treatment was indicated in 177 patients (n=163 could be analyzed based on core-laboratory data) enrolled at 23 sites. Characteristics for 164 treated lesions included moderate-severe calcification 95.1%, diameter stenosis 74.8±17.7%, and lesion length 53.6±53.1 mm. Concomitant calcium-modifying therapy was used in 32.3% of lesions. Final therapy included drug-coated balloons in 68.9% and stenting in 16.5% of lesions. Post-IVL and final residual stenoses were 29.2±16.5%and 23.6±11.5%, respectively. No vascular complications (flow-limiting dissections, perforations, embolization, slow or no reflow, or abrupt closure) were present at the end of the procedure by core-laboratory assessment, with 1 (0.8%) flow-limiting dissection initially occurring immediately following IVL treatment. This study represents the largest real-world experience of IVL treatment in heavily calcified CFA lesions. Intravascular lithotripsy treatment showed significant stenosis reduction and favorable periprocedural safety in this challenging patient population. In this study we show that calcified common femoral artery disease can be safely and effectively treated with shockwave balloon angioplasty with high procedural success and low complication rates and in clinical practice can now be offered as an alternative to surgical treatment in those patients reluctant to or high risk for vascular surgery. This opens another option for clinicians to treat calcified common femoral artery disease without the risk of dissection, perforation or distal embolization that are associated with atherectomy. This study shows that shockwave lithoplasty offers an innovative plaque modification technology to tackle calcified disease in the common femoral artery.

Analysis of Determinants for Suture-mediated Closure Device Failure During EVAR Procedures.

Endovascular aortic repair (EVAR) for elective and emergency infrarenal aortic pathologies is the primary approach for treatment nowadays. During such procedure, the suture-mediated closure device (SMCD) (Perclose ProGlideTM, Abbott Laboratories, Chicago, IL, USA) is commonly used. This study aimed to identify potential contributors for SMCD failure in a patient cohort of elective and emergency EVAR. Archived medical records from patients who underwent EVAR for aortic pathologies in elective and emergency setting at the University Hospital Düsseldorf, Germany were included. Patient's co-morbidities, access vessel morphologies and hemostasis-related blood parameters were evaluated on their association with SMCD failure applying different statistical methods. A total of 71 patients (139 femoral accesses) was included. The mean age was 73.5 ± 8.4years. Overall SMCD failure rate was 4.3%, 4.1% for elective and 5.9% for emergency cases, respectively. Total procedure time was longer for the SMCD failure group (323 ± 117.8min vs 171 ± 43.7min). The calcification status of the common femoral artery (CFA), the diameter of the aortic bifurcation, and dual anti-platelet therapy (DAPT) on the medication plan prior to the procedure were associated with SMCD failure. Univariate binary logistic regression analysis nominated several potentially relevant predictors for SMCD failure who underwent subsequent multivariable binary logistic regression analysis. Here, DAPT on the medication plan was identified as being promising in predicting SMCD failure (OR 30.5), while anterior plaque formation in the CFA maintained as only statistically relevant determinant (OR 44.9). This study confirms the CFA calcification status to be associated with SMCD failure. Although discontinued prior to endovascular treatment, DAPT was also found to be associated with SMCD failure. Our results may advocate to perform obligatory platelet testing prior to EVAR to maximize patient safety.

The Safety and Effectiveness of the Prostar XL Closure Device Compared to Open Groin Cutdown for Endovascular Aneurysm Repair.

The aim of this study is to compare the outcomes of percutaneous femoral closure with the Prostar XL for endovascular aneurysm repair (EVAR) to those of open femoral cutdown, and to evaluate factors which may predict the failure of percutaneous closure. Patients undergoing endovascular aneurysm repair for an infrarenal abdominal aortic aneurysm between 2005 and 2013 were included. Patient characteristics, anatomic femoral artery measurements, and postoperative complications were recorded retrospectively. Operator experience was defined with a cut-off point of >30 Prostar XL closures performed. Comparisons were made per access site. A total of 443 access sites were included, with percutaneous closure used in 257 cases (58.0%) and open cutdown in 186 cases (42.0%). The complication rate was 2.7% for the percutaneous and 4.3% for the open cutdown group (P = .482). No significant differences between groups were found with respect to 30-day mortality, wound infections, thrombosis, seromas, or bleeding complications. Fourteen failures (5.4%) of percutaneous closure occurred. The success rates were similar for experienced and unexperienced operators (94.2% vs 95.5%, P = .768). Renal insufficiency was more common in the failed than in the successful percutaneous closure group (64.3% vs 24.7%, P = .003). Common femoral artery calcification or diameter, BMI, sheath size, or operator experience did not predict failure. No further complications were seen in follow-up CT at 1-3years postoperatively. The use of the Prostar XL is safe compared to open cutdown. The success rate is 94.6%. Operator experience, sheath size, obesity, or femoral artery diameter or calcification do not appear to predict a failure of percutaneous closure. Complications seem to occur perioperatively, and late complications are rare.

Fracking compared to conventional balloon angioplasty alone for calcified common femoral artery lesions using intravascular ultrasound analysis: 12-month results

BackgroundFracking is a novel technique to crack calcified lesions by hydraulic pressure. This study aimed to compare the performance of fracking and conventional balloon angioplasty without stenting for calcified common femoral artery (CFA) lesions using intravascular ultrasound (IVUS) analysis.MethodsThis retrospective, single-center, comparative observational study included 59 patients (67 limbs) with calcified CFA lesions treated with either fracking (n = 30) or balloon angioplasty (n = 29) between January 2018 and December 2020. The primary endpoint was 1-year primary patency. The secondary endpoints included procedure success, freedom from target lesion revascularization (TLR), procedure-related complications, and freedom from major adverse limb events (MALE). Predictors of restenosis were identified using multivariate Cox proportional hazards analysis.ResultsThe mean follow-up duration was 403 ± 236 days. The fracking group had significantly higher incidence of 1-year primary patency (89.8% versus 49.2%, P < 0.001), procedure success (96.9% versus 74.3%, P = 0.009), and freedom from TLR (93.5% versus 74.2%, P = 0.038) than the balloon group. The rate of freedom from MALE was significantly higher in the fracking group than in the balloon group (76.9% versus 48.6%, P = 0.033). The groups had no significant difference in procedure-related complications (6.2% versus 5.7%, P = 0.928). A larger postprocedural IVUS-estimated minimum lumen area (MLA) was associated with a lower risk of restenosis (hazard ratio, 0.78; 95% confidence interval, 0.67–0.91; P < 0.001), with a cut-off value of 16.0 mm2 determined using receiver operating characteristics curve analysis. The incidence of 1-year primary patency in patients with a postprocedural MLA ≥16.0 mm2 (n = 37) was significantly higher than that in those with a postprocedural MLA < 16.0 mm2 (n = 30) (87.8% versus 44.6%, P < 0.001).ConclusionThis study demonstrated the superior procedural efficacy of fracking compared to balloon angioplasty in treating calcified CFA lesions. The safety outcomes after fracking were comparable to those after balloon angioplasty. Large postprocedural MLA was an independent positive predictor of patency.

Intravascular Lithotripsy and Drug-Coated Balloon Angioplasty for Severely Calcified Common Femoral Artery Atherosclerotic Disease

Objectives: Intravascular lithotripsy (IVL) followed by drug-coated balloon (DCB) angioplasty might be a valuable alternative to surgery for calcified common femoral artery (CFA) atherosclerotic disease. Nonetheless, the 12 months performance of this treatment strategy remains unknown. This study reports on the 12 months outcomes of IVL with adjunctive DCB angioplasty for calcified CFA lesions. Methods: This is a retrospective single-center, single-arm study. Consecutive patients treated by IVL and DCB for calcified CFA disease between February 2017 and September 2020 were evaluated. The primary measure outcome of this analysis was primary patency. Procedural technical success (<30% stenosis), freedom from target lesion revascularization (TLR), secondary patency, and overall mortality were additionally analyzed. Results: Thirty-three (n=33) patients were included in this study. The majority presented with lifestyle limiting claudication (n=20, 61%), 52% (n=17) of the patients had chronic kidney disease (CKD) and 33% (n=11) had diabetes. The procedural technical success was 97% (n=32). A flow-limiting dissection post IVL was observed in 2 patients (6%) and a peripheral embolization in a single patient (3%), while the bail-out stenting rate amounted to 12% (n=4). No perforation was observed. The median length of hospital stay was 2 days (interquartile range 2–3). At 12 months, the primary patency was 72%. The freedom from TLR and the secondary patency rates were 94% and 88%, respectively. The 12-month survival amounted to 100% and 75% (n=25) of the patients were asymptomatic or presented with mild claudication. The presence of chronic limb-threatening ischemia (CLTI) (hazard ratio [HR], 0.92; confidence interval (CI); 0.18–4.8, p=0.7) or CKD (HR, 1.30; 95% CI, 0.29–5.8; p=0.72), as well as the use of a 7 mm IVL catheter (HR, 0.59; 95% CI, 0.13–2.63; p=0.49) or of high-dose DCB (HR, 0.68; 95% CI, 0.13–3.53; p=0.65) did not influence the primary patency. Conclusions: In this study, the combination of IVL and DCB angioplasty for calcified CFA disease was associated with low risk for periprocedural complications, acceptable 12 months clinical outcomes, and low rates of reinterventions. Clinical Impact Intravascular lithotripsy in combination with DCB angioplasty can be an alternative to surgery in highly selected patients with CFA atherosclerotic disease. In this Cohort the combination therapy lead to acceptable clinical results and low reintervention rates at 12 months.

Combining transradial access and sheathless femoral access for complex iliac artery chronic total occlusions

BackgroundThe transradial approach (TRA) is associated with fewer serious access site-related complications compared with the transfemoral or transbrachial approach. However, TRA has associated problems in complex aortoiliac (AI) lesions, including the procedural difficulty. A bidirectional approach was used combining TRA with a sheathless technique for femoral artery (FA) puncture to treat complex AI lesions, as a minimally-invasive approach. This report describes a representative cases with AI chronic total occlusion in which the combination of TRA and a sheathless technique for FA puncture was useful for guidewire crossing.Case presentationCase 1 was a 71-year-old man with intermittent claudication (IC). Control angiography showed total occlusion of the left common iliac artery (CIA) ostium to the distal external iliac artery (EIA). Guidewire externalization was achieved by combining TRA using a 6Fr guiding sheath and a sheathless technique for the left FA. Two nitinol stents were deployed in the CIA to EIA. Case 2 was a 63-year-old man with IC. Control angiography revealed total occlusion of the right CIA ostium to the common femoral artery (CFA) with severe calcification. The antegrade wire could not pass through the CTO lesion because of the calcified CFA occlusion. A 21-G metal needle was used to penetrate the CFA calcification through the distal true lumen of the CFA, and the wire was inserted into the EIA for wire externalization. Three nitinol stents were deployed in the CIA to EIA, and a drug-coated balloon was dilated in the CFA with hemostasis of the distal puncture site. In both cases, the retrograde puncture site was hemostatic during the procedure and postoperative bed rest was not required.ConclusionsTRA combined with a sheathless technique from the FA has the potential to treat AI complex lesions in a less invasive manner.

Intravascular Lithotripsy vs Atherectomy in the Treatment of Calcified Common Femoral Artery Disease.

Common femoral artery (CFA) disease is often heavily calcified and prone to low patency rates with endovascular treatment compared with surgical endarterectomy. Recent data suggest promising short-term outcomes with the adjunct use of intravascular lithotripsy; however, data on its midterm effectiveness are lacking. We compared clinically driven target lesion revascularization (CD-TLR) between patients receiving drug-coated balloon angioplasty with adjunct intravascular lithotripsy (IVL-DCB) vs adjunct atherectomy (Ath-DCB) for treatment of CFA disease. In a single-center retrospective cohort study, patients receiving IVL-DCB vs Ath-DCB for symptomatic CFA disease from January 2015 to March 2020 were included. The primary outcome was cumulative CD-TLR with angiographic restenosis ≥50%, estimated by Kaplan-Meier analysis during 18-month follow-up and compared by log-rank test. Total of 68 CFA lesions (Ath-DCB, 35; IVL-DCB, 33) were included. Patients had a mean age (standard deviation) of 72 (8) years and were predominantly male (63.3%) and White (92%). Mean baseline angiographic stenosis was 78% (11) in the Ath-DCB group and 70% (10) in the IVL-DCB group (P = .002). Technical success was 100% in both groups. One flow-limiting dissection occurred in IVL-DCB requiring stent placement, whereas 2 bailout stentings were performed in the Ath-DCB group. Cumulative Kaplan-Meier freedom from CD-TLR was 91.2% (95% CI, 81.6%-100%) in the Ath-DCB group vs 79.4% (95% CI, 64.6%-94.2%) in the IVL-DCB group (Log-rank P = .167). The safety and effectiveness of IVL-DCB were comparable to those of Ath-DCB in the treatment of calcified CFA disease during the 18-month follow-up. Further studies are required to verify these findings.

Midterm Results of Intravascular Lithotripsy for Severely Calcified Common Femoral Artery Occlusive Disease: A Single-Center Experience.

Common femoral artery (CFA)-occlusive disease has traditionally been treated with open surgery, yet nowadays the frailty of patients has induced to find new techniques of revascularisation by endovascular means. So far, intravascular lithotripsy (IVL) has shown promising results in several lower limbs arterial districts. The purpose of this article is to report our experience with IVL for severely calcified peripheral arterial disease (PAD) of the CFA. From November 2018 and October 2020, 10 consecutive patients (12 limbs) treated with IVL were prospectively enrolled in a dedicated database. Inclusion criteria were CFA localization of PAD, with a severe degree of calcification, a lesion length ≥10 mm, and a degree of stenosis ≥70% (severe). The only admitted adjunctive treatment was drug-coated balloon (DCB) angioplasty. Primary outcomes were technical and procedural success, clinical success, and target lesion revascularisation (TLR). Secondary outcomes were target extremity revascularisation (TER) and major adverse events (MAEs). All patients underwent IVL with associated DCB angioplasty. The median percentage of achieved stenosis reduction was 55.5% (interquartile range [IQR] 50-60.75), with a technical and procedural success of 100%. Over the study period, TLR only occurred in one limb (8.3%), with a mean upgrade in Rutherford class of 2.7 ± 0.77. No target vessel and access site complications were reported, as well as no distal embolization. One death and one major amputation occurred over the follow-up period, both in the same patient. Based on our experience, IVL for selected cases of severely calcified CFA disease, associated with DCB angioplasty, may be considered a safe and effective technique. Of course, a long-term follow-up and a larger series of patients are needed to validate our results.

Endovascular Intravascular Lithotripsy in the Treatment of Calcific Common Femoral Artery Disease: A Case Series With an 18-Month Follow-Up

BackgroundIntravascular lithotripsy (IVL) is a novel endovascular treatment for calcified common femoral artery disease (CFA). Data on midterm effectiveness for clinically driven target lesions revascularization (CD-TLR) is lacking. This study investigated CD-TLR during 18-month follow-up in patients requiring IVL for CFA disease treatment. MethodsIn a single-center retrospective cohort study, electronic medical record of patients undergoing IVL for CFA disease from January 2018 to March 2020 were reviewed. Primary outcome was CD-TLR estimated by Kaplan-Meier method during 18-month follow-up. Univariate logistic regression was used to compare differences in CD-TLR by the type of adjunct therapy used. ResultsAmong 54 CFA lesions in 50 patients, mean age (SD) was 75(8) years, gender and race were predominantly male (74%, n = 37) and white (94%, n = 47), respectively. Rutherford class III claudication was most common (70%, n = 35) with mean ABI of 0.66 (0.26) and mean angiographic stenosis of 77% (13%). Adjunct use of drug-coated balloon (DCB) angioplasty was 83% (n = 45) and atherectomy was 39% (n = 21). Residual angiographic stenosis was <30% in all cases. Complications included dissection requiring stent placement (2%, n = 1). After 18-months, 18% (n = 9) died unrelated to procedural complications and 6% (n = 3) were lost to follow-up. 18-month cumulative freedom from CD-TLR was 80.6% (95% CI: 69.1%, 92%). Univariate logistic regression did not reveal a statistically significant difference in CD-TLR with type of adjunct therapy used (p > 0.05). ConclusionIVL with adjunct use of DCB and/or atherectomy is safe and effective in treatment of calcified CFA disease. Randomized studies are required to confirm these findings.

Preoperative Risk Factors for Access Site Failure in Ultrasound-Guided Percutaneous Treatment of TASC C and D Aorto-Iliac Occlusive Disease

At our institution, we adopted routinely ultrasound guided approach for all percutaneous procedures. The objective of this study was to describe the predictors of access site failures (ASFs) in patients undergoing percutaneous aorto iliac revascularization and to also evaluate whether other factors such as time period or different vascular devices may influence outcomes in terms of ASFs. We reviewed all consecutive percutaneous revascularizations performed for aortoiliac occlusion or stenosis at our institution from 2011 to 2020. All procedure were performed using an ultrasound (US) guided common femoral access. The primary outcome was ASFs, defined as bleeding or groin hematomas that required transfusions; pseduoaneurysm (diagnosed by US); retroperitoneal hematoma; artery laceration or ruptured (diagnosed intraoperatively); and thrombosis. Multivariable logistic regression was used to determine predictors of ASFs. A total of 502 femoral arteries were accessed under DUS guidance with no failure in sheath placement. Technical success was achieved in 498 of 502 procedures (99.2%). ASFs occurred in 21 patients (7%); but year of procedure appear to be associated with an excess of ASFs as rates were different between the first and second period of the study (10.9% vs. 4.8%, P = 0.04). Results of multivariable logistic regression model indicated that independent predictors of ASFs were common femoral artery (CFA) calcification peripheral artery calcium scoring system (PACCS) grade (odds ratio [OR], 8.7; 95% confidence interval [CI], 5.5-13.7), and CFA diameter (OR, 0.46; 95% CI, 0.25-0.85). Compared to patients with successful percutaneous access, ASFs resulted in longer post-op lengths of stay (P = < 0.001). Percutaneous US guided access can be safely performed in patients undergoing endovascular procedures for aorto iliac revascularization with TASC C and D lesions. CFA calcification PACCS grade greater than 3 and smaller femoral vessel diameter are independent risk factors for ASFs.

The \u201cFracking\u201d technique: a novel approach to crack deep calcified plaque in the common femoral artery with hydraulic pressure

BackgroundThe patency achieved by conventional peripheral interventions for atherosclerotic lesions in the common femoral artery (CFA), called the “no stenting zone”, is not superior to that achieved by surgical endarterectomy due to calcified plaque occupying the area. Plaque modification strategies to obtain acute gain in CFA patency provide the better clinical outcomes than standard balloon angioplasty. Atherectomy devices, which focus on the modification of superficial calcifications, contribute to the improvement of clinical outcomes. However, deep calcifications resist vessel expansion such that luminal gain is not easily achieved.Main textWe propose a novel calcified plaque modification technique, named the “fracking technique” (FT). The term fracking refers to how a rock is fractured by the high hydraulic pressure. In this technique, deep calcifications are cracked with hydraulic pressure via a balloon indeflator through an 18-gauge needle, which punctures calcifications to achieve greater acute luminal gain. Case 1 involved an 81-year-old male with eccentric calcified plaque in the right CFA. Conventional balloon angioplasty for the lesion yielded a suboptimal minimal lumen area (MLA), which increased from 6.2 to 10.7-mm2 on intravascular ultrasound (IVUS). The FT was implemented to obtain a larger MLA. After the FT was repeated at three locations at up to 8-atm, a greater MLA of 27.1-mm2 was achieved without complications. Case 2 involved a 72-year-old male undergoing hemodialysis due to diabetes mellitus who presented with ischemic pain in his right limbs at rest due to severe stenosis with eccentric calcification in the distal CFA. The MLA on IVUS before and after balloon angioplasty was 10.0-mm2 and 13.1-mm2, respectively, and this result was still suboptimal. The FT was attempted and successfully yielded a greater MLA of 28.9-mm2 without complications. Restenosis has not been detected for 2 years follow-up period.ConclusionsThe FT is an effective option for treating calcified CFA lesions to achieve a larger lumen area. Long-term follow-up studies are necessary.

Safety and effectiveness of Phoenix atherectomy for endovascular treatment in calcified common femoral artery lesions.

Background: Traditionally endarterectomy has been considered as the gold standard technique for the treatment of common femoral artery (CFA) lesions. The aim of this study is to investigate the procedural safety and mid-term outcomes of minimal invasive Phoenix atherectomy for the treatment of CFA lesions. Patients and methods: Phoenix atherectomy was used for treatment of 61 consecutive, moderately to heavily calcified CFA lesions in 56 patients. Lesions were classified based on the CFA occlusive disease classification (Type I, II&III lesions). Primary endpoints were technical, procedural, and clinical success rate. Safety endpoints (vessel perforation, peripheral embolization) and clinically driven target lesion revascularization (TLR) were also assessed. Results: Of 61 CFA lesions, 58 (95%) exhibited at least moderate/severe calcification (PACSS3 in 38 (62%) and PACSS4 in 20 (33%) cases). Type III lesions were present in 30 (49%), type I/II lesions in 31 (51%) cases. Technical and procedural success was achieved in 30 (49%) and all 61 (100%) lesions, respectively with low complication rates (0% perforation, 2% embolization). Adjunctive treatment after atherectomy was performed using drug-coated balloon (DCB) in 35 (57%) and bail-out stenting in 6 (10%) cases. Target lesion revascularization (TLR) occurred in 4 (7%) cases during a mean follow-up duration of 11±7months. All patients exhibited clinical improvement at follow-up, showing mean Rutherford category reduction from 3.7±1.1 to 1.5±1.1 (p<0.001). Conclusions: The Phoenix device can be used for the effective endovascular treatment of CFA lesions, due to its reasonable safety profile and mid-term results.

Efficacy of Multichannel Balloon Angioplasty in Calcified Common Femoral Artery Lesions

This report describes 7 cases in which multichannel balloon angioplasty was performed for severely calcified common femoral artery stenosis. After the successful passage of a guidewire through the stenosis, another guidewire with a tip load of 12g or 14 g was passed through a different channel inside the calcified plaques, followed by balloon angioplasty via each route. After the procedure, ankle brachial index improved from 0.49 ± 0.23 to 0.89 ± 0.05 on an average, and 6 of the 7 patients had patent arteries at a median follow-up period of 13 months. Multichannel balloon angioplasty offers the promise of being an effective endovascular intervention to expand calcified lesions.

Safety and efficacy of Mynx vascular closure device for the closure of common femoral artery access after ipsilateral stent placement.

To evaluate the feasibility and safety of the Mynx vascular closure device (VCD) for arteriotomy closure after stent placement near the common femoral artery (CFA) access site. A total of 88 patients (73 men; mean age, 72 ± 9.2 years; 136 procedures) who underwent closure of CFA arteriotomy using the Mynx VCD after stent placement in proximal superficial femoral artery (SFA) with antegrade approach, or in common or external iliac artery with retrograde approach were retrospectively studied. Technical success and access site complication were evaluated. Body mass index (BMI), platelet count, international normalized ratio, prior history of ipsilateral CFA access, access direction, degree of CFA calcification, stent location and diameter, total procedure time, and sheath size were analyzed to evaluate their relationship with technical failure and development of bleeding complications. Technical success was achieved in 94.9% (129/136) patients. The mean time to hemostasis was 0.7 ± 1.8 min. Technical failure was significantly associated with low BMI (p = 0.001). Other variables presented no significant relationship with technical failure and development of complications. Ultrasonography on the day after the procedure revealed that 8 (5.9%) patients had hematoma. Mynx VCD for arteriotomy closure is feasible and provides hemostatic safety after stent placement near antegrade or retrograde CFA access. However, Mynx VCD may have a poor technical success rate among patients with low BMI.

Incidence, Prognosis and Predictors of Major Vascular Complications and Percutaneous Closure Device Failure Following Contemporary Percutaneous Transfemoral Transcatheter Aortic Valve Replacement

ObjectivesTo determine the incidence, prognosis, and predictors of major Valve Academic Research Consortium (VARC-2) vascular complications (VCs) and percutaneous vascular closure device failure (PCDF) following contemporary percutaneous transfemoral transcatheter aortic valve replacement (TF-TAVR). BackgroundLimited data exists on the incidence and predictors of VCs and PCDFs following percutaneous TF-TAVR using contemporary 14–16 French (F) sheaths. MethodsWe recorded clinical and procedural characteristics, computer tomography (CT) angiographic data, 30-day VCs, mortality, and length of stay (LOS) in all consecutive percutaneous TF-TAVRs at a single center from June 2016 to October 2018. CT measures included common femoral artery (CFA) and external iliac artery (EIA) diameters, sheath to CFA and EIA ratios (SFAR and SEIAR), depth of CFA, extent and location of CFA calcification and pelvic vessel tortuosity (2 bends ≥90°). Multivariable regression was used to predict major VCs and percutaneous closure device failure (PCDF), respectively. ResultsThe final sample consisted of 303 percutaneous TF-TAVRs. Median age was 80 years, 51% were male, 86% Caucasian, 33% had diabetes mellitus (DM) and mean STS score was 5.8 ± 3.8%. Baseline characteristics were similar in patients with vs. without VCs, other than coronary artery disease (CAD) (69% vs. 54%, respectively; p = 0.029) and DM (21% vs. 36%, respectively; p = 0.02). There were 65 (21%) vascular complications: 19 major VCs [6.3%], 29 minor [VCs 9.6%] and 17 PCDFs [5.6%]. Overall, 30-day mortality was low (2.6%). Major VCs were associated with higher mortality (42% vs. 0%, p < 0.0001) while minor VCs (3% vs. 0%, mortality p = 0.99) and PCDFs (3% vs. 0% mortality, p = 0.99) were not. PCDFs were associated with a longer median LOS (4 vs. 3 days, p = 0.02). The independent predictors of major VCs were pelvic vessel tortuosity (OR 3.1; 95% CI 1.1–9.2) and presence of CAD (OR 8.2; 95% CI 1.8–37). Female gender showed a strong trend toward increased risk (OR 3.4; CI 0.84–14; p = 0.086). There were no independent predictors of PCDF. ConclusionContemporary percutaneous TF-TAVR is associated with a low risk of mortality, major VCs and PCDFs. Major VCs confer increased mortality and PCDFs prolong LOS. Pelvic vessel tortuosity and a history of CAD predict major VCs; there were no predictors of PCDFs. These results provide a contemporary update on the incidence and implications of these important vascular complications in the current era of percutaneous TF-TAVR using 14-16F vascular sheaths.

Factors in ProGlide® Vascular Closure Failure in Sheath Arteriotomies Greater than 16 French

The ProGlide® vascular closure device (Abbott Vascular, Redwood City, CA, USA) is approved for the closure of arterial punctures (typically 5-21 Fr sheath; maximum outer diameter, 26 Fr). However, a failure rate of about 2-8% is reported. This study was conducted to analyse factors predisposing to failure when the devices were used for the closure of large hole (16-26 Fr) arteriotomies, and to determine the predictive cut off values of predisposing factors. In this retrospective study, the ProGlide® device was used to achieve vascular access site closure in 458 patients undergoing repair of abdominal aortic aneurysm, thoracic aortic aneurysm, type B aortic dissection, or transcatheter aortic valve implantation. The primary endpoint was device failure, defined as inability to achieve common femoral artery (CFA) closure; successful repair, development of acute lower limb ischaemia and haemodynamic compromise; or delayed pseudoaneurysm formation during the follow up period, requiring open repair. Overall, ProGlide® failure occurred in 7.6% of cases. Factors that predisposed to failure included a history of peripheral arterial disease (PAD) (p<.001), the presence of CFA calcification (p<.001), the depth of the skin puncture site≥33mm (p<.001), body mass index (BMI) of ≥28.7kg/m2 (p<.001), and use of sheath size≥19 Fr (p<.001). Factors such as BMI, history of PAD, the presence of CFA calcification, the depth of the skin puncture site, and sheath size are significantly associated with ProGlide® failure. Hence, careful patient and device selection and operating procedure are paramount to achieve successful outcomes.

Usefulness of B-Flow for severe calcified common femoral artery

Usefulness of B-Flow for severe calcified common femoral artery

Acute procedural outcomes of orbital atherectomy for the treatment of common femoral artery disease: Sub-analysis of the CONFIRM Registries

This analysis compared the angiographic outcomes of patients treated with orbital atherectomy for calcified common femoral artery (CFA) and superficial femoral artery (SFA) disease. The ideal revascularization strategy for CFA disease is unknown. Endarterectomy has been considered the standard of care for CFA disease for over 50 years. Endovascular intervention is becoming more commonly used to revascularize the CFA given the advances in technology and the less invasive nature of the procedure. Patient demographics, lesion characteristics, and procedure data for all CONFIRM patients with at least one CFA lesion location ( n=147 patients; n=200 lesions) were compared to patients with at least one SFA lesion location ( n=1508 patients; n=2367 lesions). The primary endpoint was angiographic complication, defined as the composite of dissection, perforation, slow flow, closure, spasm, embolism, or thrombosis. The CFA group had more patients with Rutherford class 4 and shorter lesion length. The CFA group had a higher final residual stenosis, shorter total run time, and shorter total inflation time. The primary endpoint was lower in the CFA group compared with the SFA group (17% vs 24%, p=0.02), driven by a lower dissection rate (10% vs 15%, p=0.04). Plaque modification of the CFA with orbital atherectomy was safe and compared favorably with SFA disease. The need for bail-out stenting was low. A randomized trial is needed to determine the ideal treatment strategy for calcified CFA disease.

Totally Percutaneous Access Using Perclose Proglide for Endovascular Treatment of Aortic Diseases.

ObjectiveTo evaluate our experience following the introduction of a percutaneous program for endovascular treatment of aortic diseases using Perclose Proglide® assessing efficacy, complications and identification of potential risk factors that could predict failure or major access site complications.MethodsA retrospective cohort study during a two-year period was performed. All the patients submitted to totally percutaneous endovascular repair (PEVAR) of aortic diseases and transcatheter aortic valve implantation since we started the total percutaneous approach with the preclosure technique from November 2013 to December 2015 were included in the study. The primary endpoint was major ipsilateral access complication, defined according to PEVAR trial. ResultsIn a cohort of 123 patients, immediate technical success was obtained in 121 (98.37%) patients, with only two (0.82%) cases in 242 vascular access sites that required intervention immediately after the procedure. Pairwise comparisons revealed increased major access complication among patients with >50% common femoral artery (CFA) calcification vs. none (P=0.004) and > 50% CFA calcification vs. < 50% CFA calcification (P=0.002). Small artery diameter (<6.5 mm) also increased major access complication compared to bigger diameters (> 6.5 mm) (P=0.027).ConclusionThe preclosure technique with two Perclose Proglide® for PEVAR is safe and effective. Complications occur more often in patients with unfavorable access site anatomy and the success rate can be improved with proper patient selection.

Decalcification of a Heavily Calcified Common Femoral Artery and its Bifurcation with a Cavitron Ultrasonic Surgical Aspirator.

IntroductionSurgical endarterectomy is the preferred method for treating occlusive disease of the common femoral artery (CFA). However, endarterectomy is not always straightforward in cases with heavily calcified plaque. To overcome this limitation, a new method for decalcification, which utilizes a Cavitron ultrasonic surgical aspirator (CUSA) has been developed.ReportThe method involves full exposure of the calcified lesion. Following an arteriotomy, protruding calcification is removed using the CUSA, taking care to avoid vessel perforation. Preservation of the medial calcified layer can be accomplished by the accurate control provided by the device, which enables smooth termination in the distal area of the normal wall and does not require a tacking suture. A total of 12 patients underwent decalcification of 13 common femoral artery (CFA) lesions using CUSA with vein patch angioplasty. Concomitant profundaplasty was performed in five cases. The only intra-operative complication was perforation of the arterial wall in one patient, while another had a wound infection that required reintervention.DiscussionDecalcification of a heavily calcified CFA with CUSA appears to be feasible, although long-term follow-up examinations are warranted.