Two-year single centre results with covered endovascular reconstruction of aortic bifurcation (CERAB) in the treatment of extensive aorto-iliac occlusive disease

Objective To report the results of a single-centre in the treatment of extensive aorto-iliac occlusive disease (AIOD) by the covered endovascular reconstruction of aortic bifurcation (CERAB) technique. Methods A retrospective analysis was conducted on data obtained from the review of medical charts of all consecutive patients treated with CERAB technique for AIOD between January 2016 and December 2019 in San Giovanni-Addolorata Hospital (Rome, Italy). Clinical examination, duplex ultrasound with ankle-brachial index measurement and contrast-enhanced computed tomography angiography were performed preoperatively. A clinical and ultrasound follow-up was carried out at one month and then half yearly after the intervention to evaluate patients’ clinical status, limb salvage, target lesion revascularization rate, primary and secondary patency rate. Results During the study period, 24 patients (14 men, 58.3%; 10 women, 41.7%; median age 59 years, range 37–79 years) underwent CERAB for AIOD (TASC II C 29.2%, TASC II D 70.8%). Indications for treatment were: intermittent claudication in 18 patients (75%) and critical limb ischemia in 6 (25%). Technical success was achieved in all cases. Perioperative minor complications occurred in three cases (12.5%). One patient reported an intraoperative iliac rupture requiring adjunctive covered stenting. Median hospital length of stay was two days (range 1–9). No patient died perioperatively nor at the last follow-up. At a median follow-up of 18 months (range 6–48 months), mean ankle-brachial index increased significantly (from 0.62 ± 0.15 before the procedure to 0.84 ± 0.18) ( P < 0.001) and target lesion revascularization rate was 12.5%. At two years, the limb salvage rate was 100%, and primary and secondary patency rates were 87.5% and 100%, respectively. Conclusion CERAB technique demonstrated to be effective at the mid-term follow-up with low rate of complications and short length of stay. Long-term results and more robust data are needed to affirm this technique as the first-line treatment for extensive AIOD. However, it could become the preferred option especially in fragile patients and during contemporary COVID-19 pandemic due to the current limitations in vascular and critical care bed capacity.

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Midterm results of endovascular treatment of iliac artery lesions: analysis of 59 cases

Jornal Vascular Brasileiro ◽

10.1590/s1677-54492013000200002 ◽

2013 ◽

Vol 12 (2) ◽

pp. 91-101

Author(s):

Leonardo Ghizoni Bez

Keyword(s):

Endovascular Treatment ◽

Iliac Artery ◽

Peripheral Arterial Occlusive Disease ◽

Ankle Brachial Index ◽

Arterial Occlusive Disease ◽

Occlusive Disease ◽

Secondary Patency ◽

Iliac Arteries ◽

Peripheral Arterial

BACKGROUND: Endovascular treatment of peripheral arterial occlusive disease has become increasingly frequent in the past few years. Because it is a less invasive procedure, lower morbidity and mortality rates are associated with this form of treatment. OBJECTIVES: To describe the endovascular procedures performed in iliac arteries for the treatment of peripheral arterial occlusive disease. METHODS: This retrospective study assesses 59 cases of iliac artery angioplasty performed according to a specific protocol from January 2004 to February 2010. RESULTS: Mean age of patients was 62 years (minimum: 42, maximum: 89). Thirty seven were male (62.72%) and 22 female (37.28%). The main indications for treatment were moderate to severe intermittent claudication in 30 cases (50.84%) and rest pain or trophic lesions (critical ischemia) in 29 cases (49.15%). Postoperative follow-up included ankle-brachial index measurements and a duplex ultrasound at 30 days, 3 months, 6 months, 12 months, and every 6 months thereafter. Minimum follow-up time was 3 months, and maximum, 72 months (6 years), with primary and secondary patency rates of 91.37 and 94.82%, respectively. CONCLUSIONS: The results of this case series, combined with literature review results, allow to conclude that the endovascular approach is an effective and safe option to treat peripheral arterial occlusive disease in iliac arteries.

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Treatment of Aortoiliac Occlusive Disease With the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique: Results of a UK Multicenter Study

Journal of Endovascular Therapy ◽

10.1177/15266028211025028 ◽

2021 ◽

pp. 152660282110250

Author(s):

Athanasios Saratzis ◽

Murtaza Salem ◽

Cezar Sabbagh ◽

Said Abisi ◽

Bella Huasen ◽

...

Keyword(s):

Multicenter Study ◽

Primary Patency ◽

Occlusive Disease ◽

Tissue Loss ◽

Preoperative Imaging ◽

Secondary Patency ◽

Aortic Bifurcation ◽

Medium Term ◽

Aortoiliac Occlusive Disease

Objective This UK multicenter study aims to report early- and medium-term results following covered endovascular reconstruction of aortic bifurcation (CERAB) for the treatment of aortoiliac occlusive disease (AIOD) in patients with chronic limb threatening ischemia (CLTI) or intermittent claudication (IC). Materials and Methods Retrospective case analysis was performed of patients who underwent CERAB between November 1, 2012 and March 31, 2020 in 6 centers across the United Kingdom. Anatomical data, including degree of plaque calcification, were assessed using preoperative imaging. Outcome measures included mortality, perioperative complications, target lesion reintervention (TLR), and major limb amputation. Primary, assisted primary, and secondary patencies were calculated at set intervals. Results A total of 116 patients underwent CERAB over the study period for the following reasons [48% presenting with CLTI (Rutherford 4–6) and 52% with IC (Rutherford 1–3)]; 82% presented had Trans-Atlantic Inter-Society Consensus (TASC) D AIOD disease. Median age was 65 years (range 42–90 years); 76% of the cohort were male. Severely calcified aortic and iliac lesions were noted in 90% and 80% of patients, respectively. Over a median follow-up of 18 months (range 1–91 months), 2 (1.7%) patients were lost to follow up. In total 5, (4.3%) patients died and 2 (1.7%) had a major amputation. Endovascular TLR was required in 14 (12.1%) patients at last follow up. Surgical TLR was performed in 4 (3.4%) patients at last follow-up. Seven (6%) patients developed an aortic/iliac stent occlusion at last follow-up. The Kaplan-Meier (KM) freedom from TLR at 1 year was 94% and KM 1-year primary patency, assisted primary patency, and secondary patency were 88%, 94%, and 98% respectively. Subanalysis found the following features were associated with need for TLR; TASC D disease (OR = 2.45, 95% CI 1.44 to 3.71), severe aortic calcification (OR = 2.01, 95% CI 1.03 to 2.20), and presence of tissue loss at baseline (OR = 1.43, 95% CI 1.01 to 4.63). Conclusion Perioperative (<30 days) and medium-term morbidity, mortality, and patency rates in this pragmatic cohort of patients with severe AIOD lesions show that CERAB is a valid revascularization option. A direct comparison with surgical treatments for AIOD in a randomized controlled trial is justified.

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First-in-Human Experience With the Gore Balloon-Expandable Covered Endoprosthesis in Iliac Artery Occlusive Disease

Journal of Endovascular Therapy ◽

10.1177/1526602816680570 ◽

2016 ◽

Vol 24 (1) ◽

pp. 11-18 ◽

Cited By ~ 11

Author(s):

Andrew Holden ◽

Stephen Merrilees ◽

Brendan Buckley ◽

Brigid Connor ◽

Frances Colgan ◽

...

Keyword(s):

Iliac Artery ◽

De Novo ◽

Ankle Brachial Index ◽

Human Experience ◽

Performance Outcomes ◽

Occlusive Disease ◽

Secondary Patency ◽

Aortoiliac Occlusive Disease ◽

Safety Endpoint

Purpose: To report the first-in-human iliac artery experience of a new balloon-expandable covered endoprosthesis. Methods: A prospective, single-center pilot study recruited 30 symptomatic patients (mean age 64 years; 18 men) to evaluate the safety and early efficacy of the new Gore balloon-expandable covered endoprosthesis for the treatment of de novo or restenotic common and/or external iliac artery lesions. According to protocol, up to 2 discrete lesions could be treated with a maximum total treated length ≤110 mm. Follow-up included clinical evaluation with duplex ultrasound at 1, 6, and 12 months. Data are presented through 12-month follow-up. The primary safety endpoint was a composite of device- or procedure-related death, myocardial infarction, or amputation in the treated leg within 30 days of the index procedure. Multiple performance outcomes were also evaluated. Results: The primary 30-day safety endpoint was 0%. Per-subject estimates of primary patency, freedom from target lesion revascularization, and freedom from target vessel revascularization were 100% at 1 and 6 months and 96.6% at 12 months. Estimates of assisted primary and secondary patency were both 100% at 12 months. Freedom from major adverse events at 12 months was 100%. Most patients experienced improvements in Rutherford category, ankle-brachial index, and functional status that were sustained to 12 months. Conclusion: This positive first-in-human experience with the Gore balloon-expandable covered endoprosthesis suggests this device will have an important role in the management of aortoiliac occlusive disease.

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First-in-man experience of self-expanding nitinol stents combined with drug-coated balloon in the treatment of femoropopliteal occlusive disease

Vascular ◽

10.1177/1708538117705805 ◽

2017 ◽

Vol 26 (1) ◽

pp. 3-11 ◽

Cited By ~ 6

Author(s):

Bibombe Patrice Mwipatayi ◽

Kalpa Perera ◽

Ali Daneshmand ◽

Rhys Daniel ◽

Jackie Wong ◽

...

Keyword(s):

Target Lesion ◽

Bare Metal Stent ◽

Primary Patency ◽

Occlusive Disease ◽

Secondary Patency ◽

Target Lesion Revascularisation ◽

Metal Stent ◽

The Mean ◽

Drug Coated Balloon

Purpose The present study aimed to determine the safety and efficacy of a drug-coated balloon inflated within a thin-strut self-expanding bare-metal stent in patients with severe and complex femoropopliteal occlusive disease. Methods This prospective study used the Pulsar-self-expanding stent and Passeo-18 Lux drug-coated balloon in patients with severe and complex femoropopliteal occlusive disease. The primary endpoint was the 12-month primary patency, and the secondary endpoints included 24-month primary patency, assisted primary patency, secondary patency, and clinically associated target lesion revascularisation. Results The study included 44 patients (51 limbs). The mean age of the patients was 67.6 ± 10.2 years, with 73% men. Chronic limb severity was classified as Rutherford Category III in 41% of the patients, stage IV in 31%, and stage V in 27%. Lesions were predominantly Trans-Atlantic Inter-Society Consensus (TASC 2007) D (51%) and C (45%), with 32 (63%) chronic total occlusions. Procedural success was obtained in all cases. The mean lesion length was 200 ± 74.55 mm (95% CI = 167.09–208.01) with a mean number of stents per limb used of 1.57 ± 0.70 (95% CI = 1.37–1.76). Distal embolisation occurred in two patients. The primary patency rates at the 12- and 24-month follow-up were 94% (95% CI = 82.9–98.1) and 88% (95% CI = 75.7–94.5), respectively. The assisted primary was 94% (95% CI = 82.9–98.1) and secondary patency was 96% (95% CI = 85.2–99.0) at 24-month follow-up. The cumulative stent fracture rate at the 24-month follow-up was 10%. Freedom from clinically driven target lesion revascularisation was 94% (95% CI = 83–98%) at 12-month follow-up and 88% (95% CI = 76–94%) at 24-month follow-up, with two patients requiring a bypass graft. Conclusion Our novel approach involving the combination of a thin-strut bare-metal stent and a drug-coated balloon may be safe and effective, with sustainable and promising clinical outcomes up to 24 months after treatment.

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Drug-eluting stents for treatment of focal infrapopliteal lesions

VASA ◽

10.1024/0301-1526/a000170 ◽

2012 ◽

Vol 41 (2) ◽

pp. 90-95 ◽

Cited By ~ 10

Author(s):

Rastan ◽

Noory ◽

Zeller

Keyword(s):

Limb Salvage ◽

Bare Metal Stents ◽

Target Lesion ◽

Drug Eluting Stents ◽

Metal Stents ◽

Target Lesion Revascularisation ◽

Randomized Studies ◽

Drug Eluting ◽

The Mean

We have investigated the role of drug-eluting stents on patency rates after treatment of focal infrapopliteal lesions in patients with intermittent claudication and critical limb ischemia. Reports indicate that drug-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. A Pub Med, EMBASE, Cochrane database review search of non-randomized studies investigating patency rates, target lesion revascularisation rates, limb salvage rates and mortality rates in an up to 3-year follow-up period after drug-eluting stent placement was conducted. In addition, preliminary results of randomized studies comparing drug-eluting stents with bare-metal stents and plain balloon angioplasty in treatment of focal infrapopliteal lesions were included in this review. A total of 1039 patients from 10 non-randomized and randomized studies were included. Most commonly used drug-eluting stents were sirolimus-eluting. The mean follow-up period was 12.6 (range 8 - 24). The mean 1-year primary patency rate was 86 ± 5 %. The mean target lesion revascularization rate and limb salvage rate was 9.9 ± 5 % and 96.6 %±4 %, respectively. Results from non-randomized and preliminary results from prospective, randomized trials show a significant advantage for drug-eluting stents in comparison to plain balloon angioplasty and bare-metal stents concerning target lesion patency and in parts target lesion revascularisation. No trial reveals an advantage for drug-eluting stents with regard to limb salvage and mortality.

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Treatment of de novo coronary artery lesions with paclitaxel drug coated balloons (DCB) in diabetic and non-diabetic patients

European Heart Journal ◽

10.1093/ehjci/ehaa946.1486 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

K.M.Z Mohd Saad Jalaluddin

Keyword(s):

Myocardial Infarction ◽

Coronary Artery ◽

De Novo ◽

Target Lesion ◽

Diabetic Group ◽

Target Lesion Revascularization ◽

Diabetic Patients ◽

Coronary Artery Lesions ◽

Artery Disease

Abstract Background Drug-coated balloon has been widely used to treat In-Stent Restenosis as recommended by ESC/EACT coronary intervention guideline. However, trials of effectiveness of DCB in treating de novo lesions in diabetic patients are limited. This study will highlight the impact of DCB in diabetic patients with only de novo lesions against non-diabetic patients. Aim To compare the outcomes of Paclitaxel Drug Coated Balloon (DCB) in Diabetic and non-diabetic patients with only de novo coronary artery disease. Methods A retrospective, single center study was conducted from January 2016 till December 2018. All diabetic and non-diabetic patients underwent angioplasty to only de novo coronary artery lesions were included in the study. Patients' baseline characteristic, angiographic data, post procedural and 12 months follow-up outcomes including major adverse coronary artery event (MACE), target lesion revascularization (TLR) and myocardial infarction (MI) are compared. Results A total of 1257 patients (726 diabetic and 531 non-diabetic patients) with total 1385 de novo coronary artery lesions (791 lesions in diabetic group and 594 lesions in non-diabetic group) were included in this study. Mean age for non-diabetic group was 57.6±10.6 years and diabetic group was 59.6±9.6 years with male predominance (91.1% in non-diabetic group, n=484 and 79.2% in diabetic group, n=575). Majority of diabetic group has hypertension (83.7%, n=608 vs 58.6%, n+311), chronic renal failure (10.3%, n=75 vs 1.9%, n=10), documented coronary artery disease (55.6%, n=404 vs 47.5%, n=252) and previous coronary angioplasty 39.5%, n=287 vs 28.8%, n=153). Adequate pre-dilatation was done in both groups (98.5%, n=585 in non-diabetic group and 99.4%, n=786 in diabetic group; p=0.000). Mean DCB diameter and length were almost similar in both groups. Mean residual stenosis after DCB was 11.15±16.9% in non-diabetic group and 13.13±13.4% in the diabetic group (p=0.008). 74.6% of non-diabetic group (n=396) and 77.1% of diabetic group (n=560) were on double antiplatelet therapy for 12 months. 86.8% (n=461) of non-diabetic and 88.4% (n=642) of diabetic patients were available for follow up. MACE events were significantly higher (p=0.000) in diabetic group (4.3%, n=31) as compare to non-diabetic group (0.6%, n=3). Target lesion revascularization (TLR) and myocardial infarction (MI) was also significantly higher in diabetic group (TLR 1.4%, N=10 vs 0.6%, n=3, p=0.049; MI 2.6%, n=19 vs 0.4%, n=2, p=0.002). Conclusion Treating de novo coronary lesions in diabetic patients with DCB associated with significantly higher MACE events, target lesion revascularization and myocardial infarction. Diabetic patients appear to have a greater volume of atherosclerotic plaque and increased propensity for atherosclerotic plaque rupture. Funding Acknowledgement Type of funding source: None

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Photoablative atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis in instent femoro-popliteal obstructions (PHOTOPAC)

VASA ◽

10.1024/0301-1526/a000959 ◽

2021 ◽

pp. 1-7

Author(s):

Tanja Böhme ◽

Elias Noory ◽

Ulrich Beschorner ◽

Frederik Lerke ◽

Andrej Schmidt ◽

...

Keyword(s):

Primary Endpoint ◽

Ankle Brachial Index ◽

Target Lesion ◽

Primary Patency ◽

Small Sample ◽

Adverse Event Rate ◽

Control Cohort ◽

Procedural Success ◽

Laser Atherectomy

Summary: Background: To evaluate the safety and effectiveness of preparing instent femoropopliteal lesion with photoablative laser atherectomy or plain balloon angioplasty (POBA) prior to drug-coated balloon (DCB) angioplasty. Patients and methods: The prospective, multicenter, randomized study enrolled patients with Rutherford-Becker-class (RBC) 1 to 5 and instent lesions located in superficial femoral artery and/or popliteal artery above the knee joint. Primary endpoint was target lesion percent stenosis at 1 year as determined by the angiographic core-laboratory. Secondary endpoints included procedural success, major adverse event rate, clinical improvement and improvement in ankle-brachial index (ABI), clinically-driven target lesion revascularization (CD-TLR), and primary patency rate at until 2-year follow-up. Results: The study was terminated prior to the enrollment goal due to slow enrollment. Thirty patients were included in the laser plus DCB cohort and 31 patients in the control cohort. Primary endpoint was not significantly different (p=0.331). Procedural success was 83.3% and 87.1% for the laser plus DCB and the control cohort, respectively. Serious adverse events at 30 days and 1-year were not statistically different between the two cohorts. For the ABI, significant improvements were present at discharge as well as at the follow-up visits. This was also evident for the RBC at the follow-up visits. One- and two-year freedom from CD-TLR was 86.7% vs. 87.1%, and 63.6% vs. 72%, respectively. Duplex derived primary patency was 90% at 6-months, 65.5% at one year and 56.5% at two year for the laser cohort and 90.3%, 75.9% and 53.8% for the control cohort. Conclusions: Safety of instent photoablative laser atherectomy followed by DCB angioplasty is confirmed by this study. Due to the small sample size, no benefit over POBA as vessel preparation could be shown.

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Meta-analysis of Individual Patient Data After Kissing Stent Treatment for Aortoiliac Occlusive Disease

Journal of Endovascular Therapy ◽

10.1177/1526602818810535 ◽

2018 ◽

Vol 26 (1) ◽

pp. 31-40 ◽

Cited By ~ 5

Author(s):

Erik Groot Jebbink ◽

Suzanne Holewijn ◽

Michel Versluis ◽

Frederike Grimme ◽

Jan Willem Hinnen ◽

...

Keyword(s):

Meta Analysis ◽

Ankle Brachial Index ◽

Primary Patency ◽

Occlusive Disease ◽

Primary Study ◽

Secondary Patency ◽

Aortoiliac Occlusive Disease ◽

Cox Regression Analysis ◽

Stent Treatment ◽

Kissing Stent

Purpose: To evaluate short- and long-term technical and clinical outcomes after kissing stent treatment of aortoiliac occlusive disease (AIOD) based on an individual participant data (IPD) meta-analysis. Materials and Methods: A search of the Scopus database identified 156 articles on KS treatment of AIOD; of these 22 met the inclusion criteria. Authors of 19 articles with contact information were approached to join an IPD consortium. Eight author groups responded and 5 provided anonymized data for merging into an IPD database. The number of included procedures was equal before and after 2005. The primary study outcome was the cumulative patency at 24 months. Secondary outcomes were patency at up to 60 months, complications, and changes in Rutherford category and ankle-brachial index. The predictive value of stent protrusion length, pre-/postdilation, stent type, and patient demographics on primary patency were examined with Cox proportional hazard modeling; outcomes are reported as the hazard ratio (HR). The Kaplan-Meier method was employed to estimate patency rates. Results: In total, 605 (40.9%) of 1480 patients presented in the literature were included in the IPD analysis. The indication for intervention was intermittent claudication in 84.2% and critical limb ischemia in 15.8%. Lesions were classified as TransAtlantic Inter-Society Consensus (TASC) A or B in 52.8% and TASC C and D in 47.2%. The overall primary patency estimate was 81% at 24 months. Primary patency significantly increased after 2005 (p=0.005). Cox regression analysis revealed only age as a significant predictor of sustained primary patency (HR 0.60, p<0.005). Any previous endovascular intervention (HR 2.52, p=0.02) was the main predictor for loss of secondary patency; history of cardiovascular disease (HR 0.27, p=0.04) was the main predictor of sustained secondary patency. Conclusion: The kissing stent technique has a good safety profile and acceptable patency rates up to 2 years, even in TASC C and D lesions, supporting an endovascular-first approach for AIOD.

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Systematic Review and Proportional Meta-Analysis of Endarterectomy and Endovascular Therapy with Routine or Selective Stenting for Common Femoral Artery Atherosclerotic Disease

Journal of Interventional Cardiology ◽

10.1155/2019/1593401 ◽

2019 ◽

Vol 2019 ◽

pp. 1-12 ◽

Cited By ~ 2

Author(s):

Khalid Hamid Changal ◽

Mubbasher Ameer Syed ◽

Tawseef Dar ◽

Muhammad Asif Mangi ◽

Mujeeb Abdul Sheikh

Keyword(s):

Endovascular Treatment ◽

Femoral Artery ◽

Meta Analysis ◽

Common Femoral Artery ◽

Target Lesion ◽

Target Lesion Revascularization ◽

Inclusion Criteria ◽

One Year ◽

New Evidence

Introduction. Common femoral endarterectomy (CFE) has been the therapy of choice for common femoral artery atherosclerotic disease (CFA-ASD). In the past, there was inhibition to treat CFA-ASD endovascularly with stents due to fear of stent fracture and compromise of future vascular access site. However, recent advances and new evidence suggest that CFA may no longer be a ‘stent-forbidden zone’. In the light of new evidence, we conducted a meta-analysis to determine the use of endovascular treatment for CFA-ASD and compare it with common femoral endarterectomy in the present era.Methods. Using certain MeSH terms we searched multiple databases for studies done on endovascular and surgical treatment of CFA-ASD in the last two decades. Inclusion criteria were randomized control trials, observational, prospective, or retrospective studies evaluating an endovascular treatment or CFE for CFA-ASD. For comparison, studies were grouped based on the treatment strategy used for CFA-ASD: endovascular treatment with selective stenting (EVT-SS), endovascular treatment with routine stenting (EVT-RS), or common femoral endarterectomy (CFE). Primary patency (PP), target lesion revascularization (TLR), and complications were the outcomes studied. We did proportional meta-analysis using a random-effect model due to heterogeneity among the included studies. If confidence intervals of two results do not overlap, then statistical significance is determined.Results. Twenty-eight studies met inclusion criteria (7 for EVT-RS, 8 for EVT-SS, and 13 for CFE). Total limbs involved were 2914 (306 in EVT-RS, 678 in EVT-SS, and 1930 in CFE). The pooled PP at 1 year was 84% (95% CI 75-92%) for EVT-RS, 78% (95% CI 69-85%) for EVT-SS, and 93% (95% CI 90-96%) for CFE. PP at maximum follow-up in EVT-RS was 83.7% (95% CI 74-91%) and in CFE group was 88.3% (95% CI 81-94%). The pooled target lesion revascularization (TLR) rate at one year was 8% (95% CI 4-13%) for EVT-RS, 19% (95% CI 14-23%) for EVT-SS, and 4.5% (95% CI 1-9%) for CFE. The pooled rate of local complications for EVT-RS was 5% (95% CI 2-10%), for EVT-SS was 7% (95% CI 3 to 12%), and CFE was 22% (95% CI 14-32%). Mortality at maximum follow-up in CFE group was 23.1% (95% CI 14-33%) and EVT-RS was 5.3% (95% CI 1-11%).Conclusion. EVT-RS has comparable one-year PP and TLR as CFE. CFE showed an advantage over EVT-SS for one-year PP. The complication rate is lower in EVT RS and EVT SS compared to CFE. At maximum follow-up, CFE and EVT-RS have similar PP but CFE has a higher mortality. These findings support EVT-RS as a management alternative for CFA-ASD.

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Outcomes of Deferred Revascularization Following Physiological Coronary Assessment Using Fractional Flow Reserve

Indian Journal of Cardiovascular Disease in Women WINCARS ◽

10.1055/s-0039-3402825 ◽

2019 ◽

Vol 04 (04) ◽

pp. 190-194

Author(s):

Shabbir Ali Shaik ◽

Aramalla Sunitha ◽

Indrani Garre ◽

VS Bharathi Lakshmi

Keyword(s):

Fractional Flow Reserve ◽

Event Rate ◽

Coronary Event ◽

Target Lesion ◽

Target Lesion Revascularization ◽

Fractional Flow ◽

Noninvasive Test ◽

Flow Reserve ◽

One Year

Abstract Objective Outcomes of patients with deferred revascularization for intermediate stenosis coronary lesion based upon physiological assessment using fractional flow reserve ([FFR] >0.80). Methods Patients with chest pain with angiographic intermediate stenosis, (40–70% stenosis) without noninvasive test evidence of ischemia were selected and underwent an FFR assessment between January 1, 2015, and August 31, 2018. Patients with intermediate lesions of FFR > 0.80 were followed, and those patients with lesion with FFR < 0.8 were excluded from the study. The primary outcomes of the study were to know the composite of target lesion revascularization (TLR), myocardial infarction (MI), and other vascular complications (major adverse cardiovascular events [MACE]). Results In 102 patients who underwent deferred revascularization (FFR > 0.80), 104 FFR studies were done and followed over one year. Four patients needed target lesion revascularization (3.92%). Three patients underwent percutaneous coronary intervention (2.94%) within nine months of follow-up, and one patient underwent coronary artery bypass graft (CABG) (0.98%) at one year of follow-up. Two patients died with acute MI with sudden cardiac arrest (1.96%). Two patients developed right hemiparesis (2.94%) on one year of follow-up due to acute ischemic stroke of a middle cerebral artery, and one patient underwent permanent pacemaker implantation for complete heart block (CHB). The incidence of the total events was 8.82%, TLR was 3.92%, Coronary event rate was 5.88%, and MACE was 7.84%. Conclusions Our study shows that there was a significant increase in the incidence of coronary event rate (5.88%) and the MACE rate (7.84%) in patients of deferred coronary revascularization based on higher FFR values (>0.8).

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