Safety of Retrograde Tibial-Pedal Access and Intervention in Patients with Single Remaining Non-Occluded Infra-Popliteal Runoff Artery.

BACKGROUND: The adaptation of retrograde tibial-pedal access for peripheral angiogram and intervention is limited by the lack of operator experience and concern for small distal vessel injury. This study evaluates the safety of the retrograde tibial-pedal access for peripheral angiogram and intervention in patients with two vessel infra-popliteal artery chronic total occlusions, where the access point is the sole remaining non-occluded infra-popliteal artery. METHODS: A retrospective analysis of 5687 consecutive patients who underwent peripheral angiograms by retrograde tibial-pedal access via the single remaining non-occluded infra-popliteal artery was performed. Patients who had retrograde tibial-pedal access at the sole remaining infra-popliteal artery confirmed by angiography were included. Clinical and ultrasound data of the accessed infra-popliteal vessel up to 6 months were collected. RESULTS: The cohort consisted of 314 patients (152 males; mean age 77.9 years). At 6 months, access vessel complications occurred in 15 patients (4.8%). Access vessel occlusion occurred in 9 out of 314 patients (2.9%), arteriovenous fistula in 4 (1.3%), with spontaneous resolution in 2, pseudoaneurysm requiring thrombin injection in 2 (0.6%) and non-cardiovascular death in 1 (0.3%). No uncontrolled bleeding, procedure-related hospitalizations or limb amputations occurred. CONCLUSIONS: Routine primary retrograde tibial-pedal access for lower extremity peripheral artery diagnostic angiography and intervention in patients with single infra-popliteal artery runoff can be safety performed in an outpatient setting with infrequent and manageable complications.

Epidemiology of Diabetes and Atherosclerotic Cardiovascular Disease Among Asian American Adults: Implications, Management, and Future Directions: A Scientific Statement From the American Heart Association.

Asian American individuals make up the fastest growing racial and ethnic group in the United States. Despite the substantial variability that exists in type 2 diabetes and atherosclerotic cardiovascular disease risk among the different subgroups of Asian Americans, the current literature, when available, often fails to examine these subgroups individually. The purpose of this scientific statement is to summarize the latest disaggregated data, when possible, on Asian American demographics, prevalence, biological mechanisms, genetics, health behaviors, acculturation and lifestyle interventions, pharmacological therapy, complementary alternative interventions, and their impact on type 2 diabetes and atherosclerotic cardiovascular disease. On the basis of available evidence to date, we noted that the prevalences of type 2 diabetes and stroke mortality are higher in all Asian American subgroups compared with non-Hispanic White adults. Data also showed that atherosclerotic cardiovascular disease risk is highest among South Asian and Filipino adults but lowest among Chinese, Japanese, and Korean adults. This scientific statement discusses the biological pathway of type 2 diabetes and the possible role of genetics in type 2 diabetes and atherosclerotic cardiovascular disease among Asian American adults. Challenges to provide evidence-based recommendations included the limited data on Asian American adults in risk prediction models, national surveillance surveys, and clinical trials, leading to significant research disparities in this population. The large disparity within this population is a call for action to the public health and clinical health care community, for whom opportunities for the inclusion of the Asian American subgroups should be a priority. Future studies of atherosclerotic cardiovascular disease risk in Asian American adults need to be adequately powered, to incorporate multiple Asian ancestries, and to include multigenerational cohorts. With advances in epidemiology and data analysis and the availability of larger, representative cohorts, furthering refining the Pooled Cohort Equations, in addition to enhancers, would allow better risk estimation in segments of the population. Last, this scientific statement provides individual- and community-level intervention suggestions for health care professionals who interact with the Asian American population.

Tibio-pedal arterial pressure assessment during endovascular intervention to improve quality-of-life in patients with intermittent claudication.

Objective: The aim of this study is to compare the quality-of-life (QOL) outcomes and the tibio-pedal arterial pressure post-endovascular intervention. Background: Physiological assessment of peripheral arterial lesions is infrequently performed during endovascular interventions. Materials and methods: We retrospectively reviewed all 343 patients with intermittent claudication who underwent an endovascular intervention via tibio-pedal artery access from October 2018 to May 2021. The baseline and post-intervention tibio-pedal arterial pressures from the pedal sheaths were measured. QOL was assessed using a pre-validated Walking Impairment Questionnaire (WIQ) score before and at 30-day after intervention. We compared the baseline tibio-pedal arterial pressure, post-intervention tibio-pedal arterial pressure, delta pressure (post-intervention minus baseline), baseline WIQ scores, 30-day WIQ scores, and delta score (30-day minus baseline). Results: All 343 patients had successful tibio-pedal accesses. The average tibio-pedal arterial pressure at baseline was 87.0 ± 1.8 mmHg vs. 135.5 ± 1.7 mmHg post-intervention (p < 0.001). Average baseline and 30-day WIQ scores were summation (99.8 ± 3.3 vs. 115.0 ± 3.1, p < 0.001), walking distance (35.7 ± 1.3 vs. 42.5 ± 1.3, p < 0.001), walking speed (21.1 ± 0.9 vs. 23.6 ± 0.8, p = 0.036), stair climbing (4.7 ± 1.4 vs. 24.2 ± 1.4, p = 0.019), and symptoms (18.8 ± 0.2 vs. 20.1 ± 0.2, p < 0.001), respectively. When comparing the increased post-intervention tibio-pedal arterial pressure <60 mmHg vs. ≥60 mmHg, the average delta WIQ scores were all significantly improved with summation (10.0 ± 3.9 to 25.8 ± 5.5, p = 0.01), walking distance (4.1 ± 1.7 to 9.8 ± 2.5, p = 0.02), walking speed (1.5 ± 1.1 to 4.3 ± 1.5, p = 0.02), stair climbing (2.3 ± 1.8 to 9.4 ± 2.5, p = 0.02), and symptoms (1.0 ± 0.3 to 1.8 ± 0.4, p = 0.04), respectively. Conclusion: Increasing the post-intervention tibio-pedal arterial pressure by 60 mmHg can enhance QOL as suggested by improvement of WIQ scores.

Successful Transcatheter Closure of a Rare Malaligned Atrial Septal Defect With a Membranous Chord.

Atrial septal defect (ASD) is a common congenital defect that leads to various hemodynamic complications if untreated. Transcatheter closure (TCC) of isolated secundum ASD is the preferred treatment. Herein we describe a unique malaligned ASD secondary to a membranous chord. With balloon sizing and intracardiac echocardiography (ICE), TCC was successfully pursued. (Level of Difficulty: Beginner.).

Lower Extremity Peripheral Artery Disease: Contemporary Epidemiology, Management Gaps, and Future Directions: A Scientific Statement From the American Heart Association.

Lower extremity peripheral artery disease (PAD) affects >230 million adults worldwide and is associated with increased risk of various adverse clinical outcomes (other cardiovascular diseases such as coronary heart disease and stroke and leg outcomes such as amputation). Despite its prevalence and clinical importance, PAD has been historically underappreciated by health care professionals and patients. This underappreciation seems multifactorial (eg, limited availability of the first-line diagnostic test, the ankle-brachial index, in clinics; incorrect perceptions that a leg vascular disease is not fatal and that the diagnosis of PAD would not necessarily change clinical practice). In the past several years, a body of evidence has indicated that these perceptions are incorrect. Several studies have consistently demonstrated that many patients with PAD are not receiving evidence-based therapies. Thus, this scientific statement provides an update for health care professionals regarding contemporary epidemiology (eg, prevalence, temporal trends, risk factors, and complications) of PAD, the present status of diagnosis (physiological tests and imaging modalities), and the major gaps in the management of PAD (eg, medications, exercise therapy, and revascularization). The statement also lists key gaps in research, clinical practice, and implementation related to PAD. Orchestrated efforts among different parties (eg, health care providers, researchers, expert organizations, and health care organizations) will be needed to increase the awareness and understanding of PAD and improve the diagnostic approaches, management, and prognosis of PAD.

Perclose ProGlide embolization as a complication: case report and review of literature.

Background: Vascular closure devices have replaced mechanical compression for closure of femoral access sites after endovascular procedures. Case: We present an 87-year-old male with symptomatic infrarenal aortic aneurysm measuring 4.8 cm presenting for elective endovascular repair of the aortic aneurysm. A Perclose ProGlide Suture-Mediated Closure was used for closure. The closure was complicated by a separation of the ProGlide device resulting in the migration of the footplate to the descending aorta. Correction required snare retrieval via radial access, and the patient recovered without complications. Discussion: We highlight an important complication of the Perclose ProGlide Suture-Mediated Closure device that is rare but important to know when performing endovascular closures with this device.

Direct transpedal pressure measurement during transpedal below-the-knee interventions in critical limb ischemia.

AIM: The aim of this study was to assess the feasibility of the distal pressure measurement during transpedal below-the-knee interventions in chronic limb-threatening ischemia (CLTI) and to assess the hemodynamic response after percutaneous transluminal angioplasty. METHODS: The clinical and angiographic data of 137 consecutive patients treated via transpedal access in CLTI (Rutherford 4-6) were evaluated. Distal pedal pressure (PP) at the end of the pedal sheath was measured and the pedal-to-aortic pressure index (PAPI) was also calculated before and after the intervention. RESULTS: Good angiographic results was achieved in 131 patients (95.6%) in the femoro-popliteal and at least in one below-the-knee artery. Significant differences were found in PP and PAPI between before- and after-intervention values (103.2 ± 41.6 mmHg vs. 138.2 ± 37.8 mmHg and 0.74 ± 0.29 vs. 1.03 ± 0.34), respectively. Post-procedural PP and PAPI were significantly higher in patients who underwent good and borderline/unsuccessful intervention 141.7 [135.8-147.6] versus 82.6 [33.8-131.5] mmHg and 1.05 [1-1.1] versus 0.53 [0.2-0.8], respectively. PP's are significantly different in various Rutherford classification groups. Among the studied parameters, postprocedural PAPI was found to have the best discriminatory power to predict 3-month amputation (c-statistic: 0.749, 95% CI: 0.546-0.952, p = .016, sensitivity: 57.1%, specificity: 92.3% using the cut-off criterion ≤0.58). Major adverse event was detected in 17 patients at 3 months follow up (12.4%), including 7 major amputations (5.1%). CONCLUSION: Transpedal pressure and pedal-to-aortic pressure index significantly increased during transpedal below-the-knee angioplasty and final pressure and index correlates significantly with limb salvage.

Heart Disease and Stroke Statistics-2020 Update: A Report From the American Heart Association.

BACKGROUND: The American Heart Association, in conjunction with the National Institutes of Health, annually reports on the most up-to-date statistics related to heart disease, stroke, and cardiovascular risk factors, including core health behaviors (smoking, physical activity, diet, and weight) and health factors (cholesterol, blood pressure, and glucose control) that contribute to cardiovascular health. The Statistical Update presents the latest data on a range of major clinical heart and circulatory disease conditions (including stroke, congenital heart disease, rhythm disorders, subclinical atherosclerosis, coronary heart disease, heart failure, valvular disease, venous disease, and peripheral artery disease) and the associated outcomes (including quality of care, procedures, and economic costs). METHODS: The American Heart Association, through its Statistics Committee, continuously monitors and evaluates sources of data on heart disease and stroke in the United States to provide the most current information available in the annual Statistical Update. The 2020 Statistical Update is the product of a full year's worth of effort by dedicated volunteer clinicians and scientists, committed government professionals, and American Heart Association staff members. This year's edition includes data on the monitoring and benefits of cardiovascular health in the population, metrics to assess and monitor healthy diets, an enhanced focus on social determinants of health, a focus on the global burden of cardiovascular disease, and further evidence-based approaches to changing behaviors, implementation strategies, and implications of the American Heart Association's 2020 Impact Goals. RESULTS: Each of the 26 chapters in the Statistical Update focuses on a different topic related to heart disease and stroke statistics. CONCLUSIONS: The Statistical Update represents a critical resource for the lay public, policy makers, media professionals, clinicians, healthcare administrators, researchers, health advocates, and others seeking the best available data on these factors and conditions.

Approach to Tibiopedal Retrograde Revascularization of Below-The-Knee Peripheral Arterial Diseases With or Without Transradial Guidance Peripheral Angiography.

OBJECTIVE: We sought to compare the use of transradial peripheral angiography to guide retrograde revascularization of below-the-knee (BTK) lesions using tibiopedal access (TPA). BACKGROUND: Tibiopedal retrograde revascularization of BTK lesions is an emerging technique in peripheral interventions. METHODS: We performed an observational cohort study of 194 consecutive adult patients with critical limb ischemia (CLI) who underwent endovascular intervention for BTK diseases using peripheral angiography and primary TPA access with vs without transradial (TR) guidance at 2 centers (New York, USA and Budapest, Hungary). The primary endpoints were procedure success, 30-day major adverse event rate, 30-day access-site complication rate, and 30-day access-site patency rate by ultrasound. Secondary endpoints were periprocedural complications, fluoroscopy time, procedure length, and crossover rate to femoral access. RESULTS: There were 78 patients in the TR-guidance group and 116 patients in the non-TR guidance group. Overall procedure success rates with TR guidance vs without TR guidance were 97% and 98%, respectively. Fluoroscopy times (732.8 ± 615.7 seconds vs 769.8 ± 565.8 seconds; P=NS) and procedure times (46.5 ± 24.4 minutes vs 55.4 ± 12.6 minutes; P=NS) were similar in the TR-guidance group vs the non-TR guidance group, but contrast volumes were higher in the TR-guidance group (100.0 ± 60.1 mL vs 43.8 ± 10.2 mL in the non-TR guidance group; P<.05). There was no difference in 30-day major adverse events, other than higher amputation rate in the TR-guidance group (15.3%), which was attributed to severe baseline complex CLI status in this patient group. There was 1 case of arteriovenous fistula, 1 case of pseudoaneurysm, and 1 case of tibiopedal artery occlusion at 30 days in the group without TR guidance. There were 3 cases (3.8%) of radial artery occlusion in the TR-guidance group. CONCLUSIONS: The treatment of CLI with BTK lesions is feasible and safe, with a high procedural success rate and low access-site complication rate using the TPA approach regardless of whether or not TR guidance is utilized.

3-Year Outcomes of the DKCRUSH-V Trial Comparing DK Crush With Provisional Stenting for Left Main Bifurcation Lesions.

OBJECTIVES: The present study aimed to investigate the difference in target lesion failure (TLF) at 3 years after double kissing (DK) crush stenting versus provisional stenting (PS) for unprotected left main distal bifurcation (UPLMb) lesions. BACKGROUND: The multicenter and randomized DKCRUSH-V (Double Kissing Crush versus Provisional Stenting for Left Main Distal Bifurcation Lesions: The DKCRUSH-V Randomized Trial) study showed fewer 1-year TLF after DK crush for UPLMb lesions compared with PS. The study reports the 3-year clinical outcome of the DKCRUSH-V study. METHODS: A total of 482 patients with UPLMb lesions who were randomly assigned to either the DK crush group (DK group) or PS group in the DKCRUSH-V study were followed for 3 years. The primary endpoint was the occurrence of a TLF at 3 years. Stent thrombosis (ST) was the safety endpoint. Patients were classified by lesion's complexity and NERS (New Risk Stratification) II or SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) score. RESULTS: At 3 years, TLF occurred in 41 (16.9%) patients in the PS group and in 20 (8.3%) patients in the DK group (p = 0.005), mainly driven by increased target vessel myocardial infarction (5.8% vs. 1.7%; p = 0.017) and target lesion revascularization (10.3% vs. 5.0%; p = 0.029). Definite or probable ST rate at 3 years was 4.1% in the PS group and 0.4% in the DK group (p = 0.006). Notably, DK crush was associated with a significant reduction in both primary and secondary endpoints for patients with complex lesions or at high risk. CONCLUSIONS: Provisional stenting for UPLMb lesions was associated with significantly increased rates of TLF and ST over 3 years of follow-up. Further randomized study is warranted to confirm the benefits of DK crush stenting for complex UPLMb lesions. (Double Kissing and Double Crush versus Provisional T Stenting Technique for the Treatment of Unprotected Distal Left Main True Bifurcation Lesions: A Randomized, International, Multi-center Clinical Trial; ChiCTR-TRC-11001213).

Functional hemodynamics assessment during endovascular Tibio-pedal retrograde intervention of peripheral arterial disease.

OBJECTIVE: We sought to use a novel technique to measure the functional hemodynamics of peripheral arterial lesions during endovascular interventions. BACKGROUND: Functional hemodynamics has not been thoroughly evaluated during endovascular interventions. The aim of our study is to evaluate the feasibility and the potential benefits of pedal pressures measurements from tibio-pedal access. METHODS: We retrospectively reviewed 100 consecutive patients who underwent endovascular interventions via tibio-pedal artery access between October 3, 2018 and December 15, 2018. Baseline and postintervention pedal pressures from the pedal sheaths were measured. We also evaluated the pedal-brachial index (PBI) which is defined as the pedal sheath pressure divided by the simultaneously brachial cuff pressure. We compared baseline pedal pressures, postintervention pedal pressures, baseline PBI, postintervention PBI, % change of PBI ([postintervention PBI minus baseline PBI]/baseline PBI), and resting ankle-brachial index (ABI) versus baseline PBI in this cohort of patients. RESULTS: All 100 patients had successful tibio-pedal artery access. Baseline pedal pressure was 70 + 30 mmHg with post intervention pedal pressure of 133 + 27 mmHg (p < .001). Baseline PBI was 0.75 + 0.24 with post intervention PBI of 1.09 + 0.19 (p < .001). The correlation coefficient of resting ABI vs. baseline PBI was 0.55. The % change of PBI was 63.2 + 52.4%. There was significant improvement of postintervention PBI when compared to baseline PBI in the majority of patients. CONCLUSIONS: Obtaining pedal pressures and PBI from tibio-pedal access can be a feasible tool for endovascular interventions. This simple technique can provide us important functional hemodynamics information before and after peripheral revascularization.

Transpedal vs. femoral access for peripheral arterial interventions-A single center experience.

OBJECTIVE: To compare the transpedal approach to established femoral approach for endovascular treatment of infrainguinal peripheral arterial disease. BACKGROUND: Endovascular treatment of infrainguinal peripheral arterial disease is on the rise. Femoral approach is widely used but has significant complications. Recently the primary transpedal approach has been described for endovascular interventions. We hypothesized that transpedal approach could reduce access site related complications. We compared the two approaches in a retrospective cross-sectional study at a single center. METHODS: We analyzed demographics, procedural parameters, and complications in patients who underwent a primary transpedal approach for infrainguinal intervention and compared to patients with a traditional femoral approach in our outpatient based endovascular lab. RESULTS: The success rate for access was lower in transpedal group compared to femoral (94% vs. 100%, p = .0002). The contrast dose (44 ± 11 mL vs. 68 ± 13 mL, p < .0001), radiation dose (25 mGy [16-43] vs. 48 mGy [36-67], p < .0001) and fluoroscopy time (5.48 min [3.48-11.71] vs. 9.35 min [6.63-14.11], p < .0001) were significantly lower in transpedal group. CONCLUSION: The transpedal approach for infrainguinal revascularization appears to be a reasonable primary approach with high success and low complication rate with significant reduction in radiation and contrast dose. These findings should be further studied in a randomized controlled trial.

A Novel Patent Hemostasis Protocol - Prevention of Pseudoaneurysm after Tibiopedal Arterial Access for Evaluation and Treatment of Peripheral Arterial Disease.

BACKGROUND: Pseudoaneurysm (PSA) is a rare complication (0.2%) after transpedal arterial access (TPA) for endovascular treatment of peripheral arterial disease, occurring only in the posterior tibial artery (PTA) likely related to the anatomy of the vessel leading to unfavorable circumstances for adequate hemostasis. We describe a novel patent hemostasis protocol for TPA access to avoid PSA. METHODS: We prospectively studied 586 patients with symptomatic PAD who underwent 1038 peripheral procedures between 02/2016 and 02/2017 via TPA (dorsalis pedis artery (DP)/anterior tibial artery (ATA), PTA or peroneal artery (PA)). Hemostasis for the DP/ATA was achieved with the Vasostat™ device, while TR Band™ was used for PTA/PA, as per our new protocol (figure). Patent hemostasis technique was confirmed using Doppler. RESULTS: Of the 1038 procedures, 733 (88% interventional) were done via the DP/ATA, 176 (92% interventional) were done via the PTA and 129 (64% interventional) were via the PA. The incidence of PSA related to any access site was 0.0%. All access sites were patent on Doppler ultrasound at 30 day follow up. CONCLUSION: PSA associated with TPA is very rare, it can be easily prevented with the above described patent hemostasis protocol while preserving the patency of the access site. CONDENSED ABSTRACT: Pseudoaneurysm (PSA) is a rare complication (0.2%) after transpedal arterial access (TPA). We describe a novel patent hemostasis protocol for TPA access to avoid PSA. We prospectively studied 586 patients with symptomatic PAD who underwent 1038 endovascular procedures via TPA (dorsalis pedis artery (DP)/anterior tibial artery (ATA), PTA or peroneal artery (PA)). Hemostasis for the DP/ATA was achieved with the Vasostat™ device, while TR Band™ was used for PTA/PA, as per our new protocol (figure). Patent hemostasis technique was confirmed using Doppler. The incidence of PSA related to any access site was 0.0%. All access sites were patent on Doppler ultrasound at 30 day follow up. PSA associated with TPA is very rare, it can be easily prevented with the above described patent hemostasis protocol while preserving the patency of the access site.

Transradial versus tibiopedal access approach for endovascular intervention of superficial femoral artery chronic total occlusion.

BACKGROUND: Improved equipment and techniques have resulted in transition from surgical bypass to endovascular intervention to treat superficial femoral artery (SFA) chronic total occlusions (CTO). A change in access site to radial (TRA) or tibiopedal (TPA) artery for the treatment of these SFA CTO has been reported. The feasibility, efficacy and safety of these two access sites for treatment of SFA CTO have not been reported. METHODS: We performed an as treated analysis of 184 SFA CTO interventions in 161 patients from 01/2014 to 09/2016 using either primary TRA or TPA (operator discretion) at two institutions. Primary end point was 30 day major adverse event (MAE) - death, amputation or target vessel revascularization, secondary endpoint was success of procedure. RESULTS: Primary TRA was used in 46 patients with 47 CTO lesions .Primary TPA was used in 115 patients with 137 CTO lesions. Primary crossing success rate was higher with TRA compared to TPA (74% vs 54%, P = 0.01). Dual TRA-TPA was required in 72 prior uncrossed lesions resulting in a crossing and procedural success of 99% and 96% respectively. The overall crossing and procedural success rate using either of these approaches was 99% and 98% respectively. The 30 day MAE was 5% in TRA arm, 0% in TPA arm and 2% in dual TRA-TPA arm, P = 0.08. All access sites were patent, confirmed by ultrasound. CONCLUSION: The treatment of SFA CTO is feasible and safe using both TRA or TPA approach providing high success rates and no access site complications.

Double Kissing Crush Versus Provisional Stenting for Left Main Distal Bifurcation Lesions: DKCRUSH-V Randomized Trial.

BACKGROUND: Provisional stenting (PS) is the most common technique used to treat distal left main (LM) bifurcation lesions in patients with unprotected LM coronary artery disease undergoing percutaneous coronary intervention. The double kissing (DK) crush planned 2-stent technique has been shown to improve clinical outcomes in non-LM bifurcations compared with PS, and in LM bifurcations compared with culotte stenting, but has never been compared with PS in LM bifurcation lesions. OBJECTIVES: The authors sought to determine whether a planned DK crush 2-stent technique is superior to PS for patients with true distal LM bifurcation lesions. METHODS: The authors randomized 482 patients from 26 centers in 5 countries with true distal LM bifurcation lesions (Medina 1,1,1 or 0,1,1) to PS (n = 242) or DK crush stenting (n = 240). The primary endpoint was the 1-year composite rate of target lesion failure (TLF): cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Routine 13-month angiographic follow-up was scheduled after ascertainment of the primary endpoint. RESULTS: TLF within 1 year occurred in 26 patients (10.7%) assigned to PS, and in 12 patients (5.0%) assigned to DK crush (hazard ratio: 0.42; 95% confidence interval: 0.21 to 0.85; p = 0.02). Compared with PS, DK crush also resulted in lower rates of target vessel myocardial infarction I (2.9% vs. 0.4%; p = 0.03) and definite or probable stent thrombosis (3.3% vs. 0.4%; p = 0.02). Clinically driven target lesion revascularization (7.9% vs. 3.8%; p = 0.06) and angiographic restenosis within the LM complex (14.6% vs. 7.1%; p = 0.10) also tended to be less frequent with DK crush compared with PS. There was no significant difference in cardiac death between the groups. CONCLUSIONS: In the present multicenter randomized trial, percutaneous coronary intervention of true distal LM bifurcation lesions using a planned DK crush 2-stent strategy resulted in a lower rate of TLF at 1 year than a PS strategy. (Double Kissing and Double Crush Versus Provisional T Stenting Technique for the Treatment of Unprotected Distal Left Main True Bifurcation Lesions: A Randomized, International, Multi-Center Clinical Trial [DKCRUSH-V]; ChiCTR-TRC-11001213).

Cutoff Value and Long-Term Prediction of Clinical Events by FFR Measured Immediately After Implantation of a Drug-Eluting Stent in Patients With Coronary Artery Disease: 1- to 3-Year Results From the DKCRUSH VII Registry Study.

OBJECTIVES: This study aimed to investigate the cutoff of post-drug-eluting stent (DES) fractional flow reserve (FFR) for prediction of 1- to 3-year target vessel failure (TVF). BACKGROUND: FFR immediately after a DES implantation correlates with clinical events. However, the cutoff of post-DES FFR for predicting long-term clinical events remains understudied. METHODS: Between May 2012 and September 2013, a total of 1,476 patients who had FFR <0.8 at maximal and at baseline underwent DES implantation were prospectively studied in 9 centers. Post-DES FFR was repeat measured. The primary endpoint was the 1-year TVF rate after procedures. Receiver-operating characteristic curves were used to calculate the post-DES FFR value for TVF, then patients were classified on the basis of this value and followed up for 3 years. RESULTS: By the end of the first year, 88 (6.0%) TVFs were recorded. A post-DES FFR ≤0.88 strongly correlated with TVF. Disease in the left anterior descending coronary artery (LAD), stent length, and stent diameter were independent factors of impaired post-DES FFR, whereas post-procedure FFR ≤0.88 was the only predictor of TVF, with 40 (4.0%) TVFs in the FFR >0.88 and 48 (8.0%) in the FFR ≤0.88 group (p = 0.001), mainly driven by target vessel revascularization (3.8% vs. 8.8%; p = 0.005) and cardiac death (0.2% vs. 1.3%; p = 0.017). The difference in TVF between 2 groups was maintained through 3-year follow-up (p = 0.002). For patients with LAD lesions, a post-DES FFR ≤0.905 predicted 1-year TVF. CONCLUSIONS: Post-DES FFR strongly correlated with TVF rate. Mechanisms attributed to and treatments for impaired FFR after stenting should be studied in future studies. (Post-DES FFR Predicts the Clinical Outcomes: DK CRUSH-VII, A Prospective, Multicenter, Registry Study [DK CRUSH-VII]; ChiCTR-PRCH-12001976).

Clinical Outcome of Double Kissing Crush Versus Provisional Stenting of Coronary Artery Bifurcation Lesions: The 5-Year Follow-Up Results From a Randomized and Multicenter DKCRUSH-II Study (Randomized Study on Double Kissing Crush Technique Versus Provisional Stenting Technique for Coronary Artery Bifurcation Lesions).

BACKGROUND: Provisional stenting is effective for anatomic simple bifurcation lesions. Double kissing crush stenting reduces the 1-year rate of target lesion revascularization. This study aimed to investigate the 5-year clinical results of the DKCRUSH-II study (Randomized Study on Double Kissing Crush Technique Versus Provisional Stenting Technique for Coronary Artery Bifurcation Lesions). METHODS AND RESULTS: A total of 370 patients with coronary bifurcation lesions who were randomly assigned to either the double kissing crush or provisional stenting group in the DKCRUSH-II study were followed for 5 years. The primary end point was the occurrence of a major adverse cardiac event at 5 years. Patients were classified by simple and complex bifurcation lesions according to the DEFINITION criteria (Definitions and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents). At 5 years, the major adverse cardiac event rate (23.8%) in the provisional stenting group was insignificantly different to that of the double kissing group (15.7%; P=0.051). However, the difference in the target lesion revascularization rate between 2 groups was sustained through the 5-year follow-up (16.2% versus 8.6%; P=0.027). The definite and probable stent thrombosis rate was 2.7% in each group (P=1.0). Complex bifurcation was associated with a higher rate of target lesion revascularization (21.6%) at 5 years compared with 11.1% in patients with a simple bifurcation (P=0.037), with an extremely high rate in the provisional stenting group (36.8% versus 12.5%, P=0.005) mainly because of final kissing balloon inflation (19.4% versus 5.2%; P=0.036). CONCLUSIONS: The double kissing crush stenting technique for coronary bifurcation lesions is associated with a lower rate of target lesion revascularization. The optimal stenting approach based on the lesions' complexity may improve the revascularization for patients with complex bifurcations. CLINICAL TRIAL REGISTRATION: URL: http://www.chictr.org. Unique identifier: ChiCTR-TRC-0000015.

Pseudoaneurysm after transpedal arterial access for evaluation and treatment of peripheral arterial disease.

BACKGROUND: There has been an increasing use of transpedal arterial access (TPA) for evaluation and treatment of peripheral arterial disease (PAD) over a transfemoral approach (TFA). TPA, it is expected to be associated with better patient comfort, less recovery time and possibly less access site complications compared to standard TFA. Access site complications and pseudoaneurysm (PSA) associated with the TPA have not been previously reported. OBJECTIVE: Here we report a series of pedal artery PSA related to access site complicating TPA catheterization. METHODS: We studied 1460 patients with symptomatic PAD who underwent 2236 peripheral diagnostic and/or interventional procedures between 06/2014 and 01/2016 via TPA. Hemostasis was achieved using patent hemostasis technique by a radial artery compression device for 2h. PSA related to the access site were suspected clinically and confirmed with arterial duplex ultrasound. RESULTS: The incidence of PSA related to any access site was 0.002%. In this series all PSA occurred only in the posterior tibial artery, after an interventional procedure. All patients were treated successfully with thrombin injection with no residual complications. CONCLUSIONS: PSA associated with TPA is extremely rare and seems to occur exclusively after posterior tibial artery access. It is easily treatable by thrombin injection.

Percutaneous Femoropopliteal Recanalization Using a Completely Transpedal/Transtibial Approach.

PURPOSE: To report preliminary experience with femoropopliteal revascularization using a completely transpedal/transtibial approach. MATERIALS AND METHODS: Three patients with Rutherford 3-4 disease underwent revascularization of TASC C/D lesions using a pedal/tibial artery as the only site of arterial access. RESULTS: One patient with a chronic superficial femoral artery occlusion had continuity achieved to the common femoral artery using a dedicated reentry device and stenting; in a second patient, an occluded popliteal artery stent was successfully revised with an endograft; and in a third patient with morbid obesity, a chronic SFA occlusion was successfully stented. All patients experienced complete resolution of presenting symptoms; no puncture site complications were seen. CONCLUSIONS: Use of a pedal/tibial approach as the sole site of arterial access may become an important access technique for femoropopliteal revascularization when patients have limited femoral access options.