Wael E. Saad

Impact of runoff on superficial femoral artery endoluminal interventions for rest pain and tissue loss

BACKGROUND While aggressive endoluminal therapy for superficial femoral artery (SFA) occlusive disease is commonplace, the implications of runoff on long-term outcomes of these interventions in patients with rest pain and tissue loss is unclear. Runoff is known to negatively effect graft patency. The aim of this study is to examine the impact of distal runoff on long-term outcomes of SFA interventions for critical ischemia. METHODS A prospective database of patients undergoing endovascular treatment of the SFA between 1986 and 2007 was queried. Patients with Rutherford symptom classification 4, 5, and 6 were selected. Patients with concomitant tibial interventions were excluded. Pre-operative angiograms were reviewed in all cases to assess distal popliteal and tibial runoff and were scored according to modified Society of Vascular Surgery criteria for both vessels such that a higher score implies worse runoff (minimum 1 and maximum 19). Three runoff score groups were identified: <5 (good), 5-10 (compromised), and >10 (poor). Kaplan-Meier survival analyses were performed to assess time-dependent outcomes. Multivariate and factor analyses were performed. RESULTS Three hundred six limbs in 241 patients (57% male, mean age 68 years) underwent endovascular treatment for critical ischemia (44% rest pain and 56% tissue loss.) Technical success was 96% with 61% SFA undergoing angioplasty, 37% SFA primary stenting and 2% SFA an atherectomy. Overall mortality was 1% and overall morbidity was 16% at 90 days after the procedure. At 5 years, vessels with compromised and poor runoff had significantly worse cumulative patency (82 +/- 9%, 56 +/- 4%, and 52 +/- 7% for good, compromised, and poor runoffs, respectively, mean +/- standard error of the mean [SEM]). Freedom from recurrent symptoms (65 +/- 8%, 39 +/- 9%, and 18 +/- 9% for good, compromised, and poor runoffs, respectively) and limb salvage (65 +/- 5%, 41 +/- 4%, and 20 +/- 6% for Good, Compromised, and Poor runoffs, respectively) were incrementally curtailed by worsening runoff with significant decreases as runoff category deteriorated. CONCLUSIONS In patients presenting with rest pain and tissue loss who are treated with SFA percutaneous interventions, patency is negatively affected by compromised and poor runoffs in keeping with the bypass literature. More importantly, freedom from recurrent symptoms and limb salvage are incrementally curtailed as runoff scores worsen. These findings are consistent with the bypass literature.

The long-term outcomes of percutaneous therapy for renal artery fibromuscular dysplasia

BACKGROUND Percutaneous intervention for symptomatic renal artery fibromuscular dysplasia (FMD) has replaced surgical therapy as first-line treatment. This study evaluates the factors that impact long-term anatomic and functional outcomes of endovascular therapy for symptomatic renal artery FMD. METHODS Records of patients who underwent renal artery angioplasty for FMD between January 1990 and December 2007 were retrospectively analyzed. Indication for intervention was poorly controlled hypertension (diastolic blood pressure >90 mm Hg or systolic blood pressure >140 mm Hg, or both, taking >2 antihypertensive medications). Twenty-nine women (average age, 45 years [range, 18-80]; 86% with a history of hypertension <8 years) underwent 38 attempted interventions. Sixty-six percent of contralateral kidneys were normal (31% had a </=60% stenosis), 13% had >60% stenosis, and the remainder were nonfunctioning or absent. Creatinine was >1.5 mg/dL in 4%, 24% had hyperlipidemia, 17% had metabolic syndrome, and 4% were considered diabetic. OUTCOMES All interventions were successfully performed. Stent placement was required in 13% for technical failure and flow-limiting dissection. Seventy-three percent of these lesions were in the proximal renal artery, with the remainder in the middle renal artery. Technical success (<30% residual stenosis) was achieved in all vessels. There were no periprocedural or 90-day deaths. The procedurally related complication rate was 8%. Median follow-up was 2 years. All patients were alive at follow-up. Primary and assisted primary patency rates were 66% and 87% at 5 years. Restenosis was considered a 50% reduction in luminal area on angiography during follow-up. The restenosis rate was 28% at 5 years (10 vessels underwent repeat percutaneous intervention). Immediate clinical benefit was seen in hypertension in 72% (improved or cured </=3 months) and was maintained in 73% at 5 years by life-table analysis. Proportional hazard analysis showed the predictors of long-term clinical benefit were duration of hypertension <8 years, creatinine <1.5 mg/dL, ipsilateral kidney size >9 cm, functional status of the contralateral kidney, a fasting blood glucose <110 mg/dL, triglycerides <150 mg/dL, and high-density lipoprotein >50 mg/dL. Neither age <50 years nor statin administration appeared significant. CONCLUSIONS Percutaneous endovascular intervention for clinically symptomatic FMD in the renal arteries is technically successful, safe, and durable. Most patients have immediate clinical benefit, with continued long-term results out to 5 years. It appears that the presence of existing renal pathology and markers of prediabetic state are associated with recurrence of hypertensive symptoms.

Percutaneous superficial femoral artery interventions for claudication--does runoff matter?

Endoluminal therapy for superficial femoral artery (SFA) occlusive disease for claudication is commonplace, but the implications of tibial vessel runoff on long-term outcomes of these interventions in patients with claudication are unclear. Runoff is known to negatively affect graft patency, but no data are available on the impact of runoff on percutaneous SFA interventions and their implications during follow-up. We examined the impact of distal popliteal and tibial runoff on long-term outcomes of SFA interventions for claudication. A prospective database of patients undergoing endovascular treatment of the SFA between 1986 and 2007 was queried. Patients with Rutherford symptom classifications 1, 2, and 3 were selected; those with concomitant tibial interventions were excluded. Angiograms were reviewed preoperatively in all cases to assess distal popliteal and tibial runoff and scored according to modified Society for Vascular Surgery criteria for both vessels such that a higher score implies worse runoff (minimum 1, maximum 19). Three run-off score groups were identified: <5 (good), 5-10 (compromised), and >10 (poor). Kaplan-Meier survival analyses were performed to assess time-dependent outcomes. Multivariate and factor analyses were performed. There were 481 limbs in 347 patients (70% male, average age 66 years) that underwent endovascular SFA treatment for claudication: 87% had hypertension, 51% had diabetes mellitus, 67% had hyperlipidemia, and 16% had chronic renal insufficiency (1% on hemodialysis). Technical success was 92%, with 63% SFA undergoing angioplasty, 26% SFA undergoing primary stenting, and 3% SFA undergoing atherectomy. Overall mortality was 1.1% and overall morbidity was 17% at 90 days after the procedure. At 5 years, vessels with compromised and poor runoff had significantly lower freedom from recurrent symptoms and lower freedom from restenosis. Primary and assisted primary patency rates were significantly worse in patients with poor runoff. However, secondary patency was equivalent between the groups. Compromised or poor runoff was associated with incremental lower limb salvage. Following SFA percutaneous interventions for claudication, runoff can identify patients more likely to develop restenosis and recurrent symptoms and, more importantly, those at higher risk of limb loss. Defining such subgroups allows a clear risk stratification of patients with claudication and can guide the intensity of surveillance in the outpatient setting.

Implications of Acute Functional Injury following Percutaneous Renal Artery Intervention

Percutaneous renal artery revascularization for hypertension and renal dysfunction is now common, and there is an increasing realization that renal artery intervention can be associated with parenchymal injury. The frequency, cause, and outcomes of acute functional injury associated with renal intervention are poorly delineated. Our aim was to determine the frequency of acute functional renal injury 30 days after renal artery intervention, to identify factors associated with functional renal injury and determine whether functional renal injury related to renal intervention is associated with late adverse clinical events. A retrospective analysis of patients undergoing renal artery interventions for atherosclerotic renal artery disease between 1990 and 2007 was performed. No distal embolic protection devices were used. Acute functional parenchymal renal injury was defined as a persistent increase in serum creatinine of > or =0.5 mg/dL at 1 month after the procedure. Freedom from kidney-related morbidity (increase in persistent creatinine >20% of baseline, progression to hemodialysis, death from kidney-related causes) and patient survival were measured. There were 418 patients who underwent 581 renal artery interventions: 57% for hypertension, 23% for hypertension associated with chronic renal insufficiency, and 12% for renal insufficiency. Acute functional renal injury occurred in 20% of the patients. The occurrence of a functional injury was associated with a significant decrement in freedom from kidney-related morbidity (mean +/- SEM 80 +/- 2% vs. 55 +/- 10%, no injury vs. injury, p < 0.01) and markedly decreased survival at 5-year follow-up (71 +/- 4% vs. 41 +/- 10%, p < 0.01). At 5-year follow-up, three times as many patients with functional injury progressed to hemodialysis compared to those without injury (19% vs. 7%, p < 0.01). By multivariate analysis, the presence of an unrepaired abdominal aortic aneurysm (AAA), low estimated glomerular filtration rate, non-insulin-dependent diabetes mellitus, contralateral renal artery disease, and a solitary kidney were significantly associated with functional injury and poor long-term clinical benefit. Hypertension, hyperlipidemia, and contrast volume were determined to be not significant. Acute functional renal injury occurs in approximately 20% of patients undergoing percutaneous renal artery intervention and is more likely in the presence of an unrepaired AAA, non-insulin-dependent diabetes mellitus, and preexisting renal disease. Acute functional renal injury is a negative predictor of survival and is associated with subsequent renal failure, need for dialysis, and death. While this data set does not establish a causal relationship, patients who are predisposed to acute functional injury may have underlying factors that also lead to decreased long-term renal function and decreased survival.

Outcomes of reintervention for recurrent disease after percutaneous iliac angioplasty and stenting

Purpose To evaluate the outcomes of percutaneous therapy for symptomatic >50% angiographic restenosis after iliac intervention versus outcomes of the primary procedure. Methods A retrospective analysis was performed of 937 patients (733 men; mean age 65 years) who underwent 1532 endovascular interventions for symptomatic atherosclerotic iliac artery obstruction and were followed by duplex ultrasound between 1990 and 2009. In this population, 374 vessels restenosed (>50% on duplex); about half (176, 47%) were associated with recurrent symptoms. In 102 symptomatic patients (58 men; mean age 61 years), 147 limbs (84%) had repeat angioplasty/stenting and were compared to the primary treatment group. Results Thirty-day mortality was <1% in both primary and recurrent treatment groups, but morbidity was doubled in the reintervention group (4% versus 8%; p<0.05). While the incidence of systemic complications was low in both groups, the drivers for increased morbidity in the recurrent group were lesion-specific and access-site complications. In the 937-patient cohort, the rate of >50% restenosis on duplex was 15%±1% at 5 years. Gender (p=0.03), diabetes (p=0.04), metabolic syndrome (p=0.001), symptoms (p<0.001), angioplasty alone (p=0.04), concurrent superficial femoral artery occlusion (p=0.02), and increasing complexity of the iliac intervention (p=0.02) were associated with primary failure. Patency rates at 10 years for primary versus recurrent treatment were 73%±2% versus 66±8% for primary patency (p=0.004); 88%±2% versus 74%±7% for assisted primary patency (p=0.005); and 90%±2% versus 78%±10% for secondary patency (p=0.002). Female gender (p=0.01), continued smoking (p=0.02), eGFR <60 mL/min/1.73m2 (p=0.03), lesion length (p=0.02), lesion calcification (p=0.005), and TASC II category (p=0.04) negatively influenced patency of recurrent lesions. Sustained clinical success (absence of recurrent symptoms) was 74%±2% in the primary group and 66%±8% in the restenotic group (p=0.014) at 10 years. Symptoms (p=0.04), female gender (p=0.002), hypertension (p=0.004), eGFR <60 mL/min/1.73 m2 (p=0.02), external iliac artery disease (p=0.02), lesion length (p=0.02), and poor immediate clinical outcome (p<0.001) negatively influenced clinical success of recurrent lesions. Conclusion Percutaneous reintervention for recurrent iliac artery disease has a higher procedure-related morbidity compared to primary intervention. Longer-term outcomes are also poorer than for primary lesions. The patients who present with restenosis are more likely to be younger and of female gender than patients presenting for primary intervention. Both patency and functional outcomes after reintervention are worse than those for primary interventions.

Implications of In Situ Thrombosis and Distal Embolization during Superficial Femoral Artery Endoluminal Intervention

BACKGROUND Endoluminal therapy for superficial femoral artery (SFA) occlusive disease is commonplace, but the incidence and outcomes of in situ thrombosis (IST) and distal embolization (DE) have not been well defined. The aim of this study was to examine the impact of IST and DE on long-term outcomes of SFA interventions. METHODS A database of patients undergoing endovascular treatment of the SFA was queried. Patients who developed either IST treated by pharmacomechanical lytic therapy or DE were selected and compared to those without either event (control). Kaplan-Meier survival analyses were performed to assess time-dependent outcomes, with 2-year outcomes reported. Factor analyses were performed using a Cox proportional hazard model for time-dependent variables. RESULTS There were 818 limbs that underwent endovascular treatment for symptomatic SFA disease (59% for claudication and 41% rest pain and tissue loss). In the control group, 69% underwent angioplasty, 16% underwent primary stenting, and 15% underwent laser/directional atherectomy. In the IST group, these numbers were 41%, 28%, and 31%, respectively, while in the DE group they were 35%, 32%, and 33%, respectively. Overall the rates were 7.3% with 3.5% suffering IST (all treated with lytic therapy) and 3.8% suffering DE (68% treated percutaneously and the remainder treated by embolectomy). Females were more likely to experience either event. Compared to the control group, only one-third of the patients who suffered DE had primary angioplasty, while the remainder underwent primary stenting or laser/directional atherectomy. There was no difference in primary, assisted primary, or secondary patency rates between the control and DE groups. DE resulted in significantly lower limb salvage (87 + or - 2% vs. 68 + or - 8%, control vs. DE, p<0.05) and freedom from recurrent symptoms (73 + or - 2% vs. 69 + or - 8%, control vs. DE, p<0.05), while IST treated with lytic therapy was associated with lower patency (67 + or - 2% vs. 37 + or - 6% primary, 77 + or - 2% vs. 41 + or - 9% assisted primary, and 79 + or - 2% vs. 44 + or - 9%, secondary, control vs. IST, p<0.01). There was no difference in outcomes based on whether surgical or percutaneous therapy was used to treat DE. While preoperative tibial runoff did not influence limb loss after DE, it was significantly associated with decreased patency after IST. CONCLUSION DE during SFA interventions is associated with limb loss independently of preoperative runoff and subsequent intervention while the use pharmacomechanical lytic therapy for IST is associated with loss of patency but equivalent limb salvage and freedom from recurrent symptoms.

Impact of metabolic syndrome on the outcomes of percutaneous renal angioplasty and stenting

BACKGROUND Endovascular therapy for symptomatic atherosclerotic renal artery stenosis (ARAS) is common and effective in the well-selected patient. Hypertension is a common indication for intervention and a major component of metabolic syndrome (MetS). The impact of MetS on outcomes after percutaneous renal intervention is unknown. METHODS We performed a retrospective analysis of records from patients who underwent endovascular intervention for ARAS and were followed by duplex ultrasound between January 1990 and January 2008. MetS was defined as the presence of >or=3 of the following criteria: Blood pressure >or=140 mm Hg/>or=90 mm Hg; triglycerides >or=150 mg/dL; high-density lipoprotein <or=50 mg/dL for women and <or=40 mg/dL for men; fasting blood glucose >or=110 mg/dL; or body mass index >or=30 kg/m(2). The average follow-up period was 3.3 years. Clinical benefit defined as freedom from renal-related morbidity (increase in persistent creatinine >20% of baseline, progression to hemodialysis, death from renal-related causes) or freedom from recurrent hypertension, anatomic patency, restenosis, and patient survival were measured. RESULTS Five hundred ninety-two renal artery interventions were performed in 427 patients. Fifty-two percent were identified as having MetS. Patients with MetS were more often female (35% vs 50%, NoMetS vs MetS). There were no significant differences in presenting symptoms. There was no peri-operative mortality and equivalent morbidity (6% vs 7%, NoMetS vs MetS). Patients with MetS had equivalent survival and cumulative patency. However, the MetS group had a lower five-year freedom from restenosis (87+/-2% vs 69+/-9%, NoMetS vs MetS; P < .01) and lower five-year retained clinical benefit (71+/-8% vs 45+/-8%, NoMetS vs MetS; P < .01) with a higher number progressing to hemodialysis (3% vs 13%, NoMetS vs MetS; P < .01). Individually, the components of MetS did not influence outcomes. Statin therapy did not influence outcomes. CONCLUSION MetS is associated with markedly reduced renal clinical benefit and increased progression to hemodialysis following endovascular intervention for atherosclerotic renal artery stenosis. MetS is thus a risk factor for poor long-term outcomes following renal interventions.

Endovascular revascularization of renal artery stenosis in the solitary functioning kidney

BACKGROUND Endovascular therapy for symptomatic atherosclerotic renal artery stenosis (ARAS) is considered effective. This study evaluates the factors that impact long term anatomic and functional outcomes of endovascular therapy of ARAS in patients with a solitary functioning kidney. METHODS We performed a retrospective analysis of records from patients who underwent endovascular intervention for ARAS and identified patients with a solitary functioning kidney (absent or nonfunctioning contralateral kidney) and patients with contralateral normal kidney (for comparison) between January 1990 and January 2008. Indications for intervention in the solitary functioning kidney were poorly controlled hypertension (diastolic blood pressure [BP] >90 mm Hg on >3 antihypertensive medications) and/or elevated creatinine (Cr >/=1.5 mg/dL). Clinical benefit was defined as freedom from composite recurrent symptoms (recurrent hypertension or renal-related morbidity-increase in persistent creatinine >20% of baseline, progression to hemodialysis, and death from renal-related causes), anatomic patency and patient survival were measured. RESULTS A total of 242 patients (56% male, average age 69 years, range, 45-90) underwent angioplasty (23%) or primary stenting (77%) of a single renal artery with a normal contralateral renal vessel and kidney and 73 patients (58% male, average age 70 years, range, 52-89) underwent angioplasty (37%) or primary stenting (63%) for a solitary functioning kidney. There were no significant differences in mortality or morbidity between the groups. There was a significant difference in the long-term survival with 55 +/- 8% patients with a normal contralateral kidney vs 27 +/- 7% patients with a solitary functioning kidney alive at 10 years. Clinical benefit was 67 +/- 6% and 67 +/- 4% at 5 years and 63 +/- 8% and 62 +/- 4% at 10 years for solitary functioning kidney and normal contralateral groups, respectively. Using proportional hazard analysis, the predictors of long-term clinical benefit were ipsilateral kidney size (>9 cm), no immediate deterioration in function, and an estimated Glomerular Filtration Rate (eGFR) >30 mL/min/1.73m(2). Neither control of diabetes nor the administration of statins was shown to influence outcomes in the solitary functioning kidney. CONCLUSION Intervention in patients with a solitary functioning kidney is a safe procedure and improves or stabilizes renal function in 82% of patients. Clinical benefit is dictated by preoperative GFR, renal size, and the occurrence of acute functional injury after the procedure.

Outcomes of interventions for recurrent disease after endoluminal intervention for superficial femoral artery disease

BACKGROUND Aggressive endoluminal therapy for superficial femoral artery (SFA) occlusive disease is commonplace, but the outcomes of current management of recurrent disease have not been well defined. This study examined the outcomes of endoluminal and open interventions for recurrent SFA disease. METHODS A database of patients undergoing endovascular treatment of the SFA between 1986 and 2008 was retrospectively queried, and those with recurrent disease were selected. Outcomes were determined by Kaplan-Meier survival analyses, and the Cox proportional hazard model was used for time-dependent variables. RESULTS Symptomatic SFA disease resulted in endovascular treatment in 735 limbs in 631 patients (64% male; average age, 67 years). The restenosis rate was 16% +/- 3% at 5 years. Restenosis developed in 222 patients, of whom 58 remained asymptomatic and 164 underwent repeat intervention comprising percutaneous transluminal angioplasty (PTA) in 59% and bypass in 41%. Bypass was used for critical ischemia (rest pain/tissue loss: 52% repeat PTA vs 75% bypass) and in more extensive recurrent disease (TransAtlantic Inter-Society Consensus [TASC] II C/D lesions: 42% repeat PTA vs 67% bypass). Primary and repeat PTA had mean +/- standard error of the mean equivalent cumulative patency (73% +/- 9% vs 73% +/- 3% at 5 years) and duration of symptom relief (66% +/- 3% vs 63% +/- 6%). Bypass had significantly superior outcomes for patency (93% +/- 8%) and symptom relief (81% +/- 8%), but morbidity was 28% vs 16% for PTA. Critical ischemia, TASC-II lesion (C/D), and one-vessel tibial runoff were significant predictors of failure in the repeat PTA group. CONCLUSIONS Reintervention is required in a minority of patients selected for SFA angioplasty. Bypass for recurrent disease is used more commonly for extensive disease and is associated with superior long-term outcomes but higher mortality. Bypass rather than repeat PTA may be the better strategy for progressive, complex recurrent disease.

Renal parenchymal preservation after percutaneous renal angioplasty and stenting

BACKGROUND The intent of endovascular therapy for symptomatic atherosclerotic renal artery stenosis (ARAS) is to preserve parenchyma and avoid renal-related morbidity. The aim of this study is to examine the impact of renal artery intervention on parenchymal preservation. METHODS We performed a retrospective analysis of records from patients who underwent endovascular intervention for ARAS and were followed by duplex ultrasound between 1990 and 2008. Renal volume (in cm(3)) was estimated in all patients as renal length (cm) x renal width (cm) x renal depth (cm) x 0.5. The normal renal volume was calculated as 2 x body weight (kg) in cm(3). Failure of preservation was considered to be a persistent 10% decrease in volume. Clinical benefit defined as freedom from renal-related morbidity (increase in persistent creatinine >20% of baseline, progression to hemodialysis, death from renal-related causes) was calculated. RESULTS Five hundred ninety-two renal artery interventions were performed. One hundred eighty-six kidneys suffered parenchymal loss (>5%) with an actuarial parenchymal loss rate of 29% +/- 1% at five years respectively. There were no significant differences in age, gender, starting renal volume, or kidney size. However, patients with parenchymal loss had lower eGFR (45 +/- 24 vs 53 +/- 24 mL/min/1.73 m(2); Loss vs noLoss, P = .0002, Mean +/- SD) higher resistive index (0.75 +/- 0.9 vs 0.73 +/- 0.10; P = .0001) and worse nephrosclerosis grade (1.43 +/- 0.55 vs 1.30 +/- 0.49; P = .006) then those not suffering parenchymal loss. Parenchymal loss was associated with significantly worse five-year survival (26% +/- 4% vs 48% +/- 2%; Loss vs noLoss; P < .001) and freedom from renal-related morbidity (70% +/- 5% vs 82% +/- 2%; P < .05) with increased numbers progressing to dialysis (17% vs 7%; P < .006). CONCLUSION While parenchymal preservation occurs in most patients, parenchymal loss occurs in 31% of patients and is associated with markers of impaired parenchymal perfusion (resistive index and nephrosclerosis grade) at the time of intervention. Pre-existing renal size or volumes were not predictive of parenchymal loss. Parenchymal loss is associated with a significant decrease in survival and a marked increased renal related morbidity and progression to hemodialysis.