K. Balzer

Prospective randomized trial of operative vs interventional treatment for renal artery ostial occlusive disease (RAOOD)

INTRODUCTION AND OBJECTIVES Patients with either renovascular hypertension (RVH) and/or renal insufficiency (RI) due to renal artery ostial occlusive disease (RAOOD) can successfully undergo an open surgical reconstruction procedure (OSRP), but since the publication of Blum et al(1) percutaneous balloon stent angioplasty (PTRA + stent) leaving a small part of the stent within the aorta has become very popular. However, balloon dilatation and stenting does not remove the atherosclerotic plaque, which is often heavily calcified but leads to disruption of the plaque causing myointimal hyperplasia and recurrent stenosis. Therefore, a comparison of the two treatment modalities concerning complications and durability in a prospective randomized design was felt to bring more insight to the discussion. METHODS From 1998 to 2004, we performed OSRP in 330 patients with RVH and/or RI for various locations of RAOOD. During this time period, 50 patients (female 18, male 32, mean age 64.4 years) with RAOOD of at least 70% stenosis (DSA and duplex criteria) in one or both renal arteries, who did not require other aorto/mesenteric/iliac reconstructive procedures agreed and were randomized to either OSRP (n = 25 patients, 49 arteries) or PTRA + stent (n = 25 patients, 28 arteries). Two patients crossed over to surgical treatment. Patients were followed on a regular basis for 4 years and longer. Endpoints were re-occurrence of RAOOD and impairment of either kidney function or RVH. RESULTS We approached 77 arteries. There was no early mortality in either group, but directly procedure-related morbidity was 13% in the interventional group and 4% in the surgical group. Four-year follow-up mortality was 18% in the interventional group and 25% in the surgical group. Both groups showed significant improvement of RVH (P < .001 in each group) as well as improvement or stabilization in patients with insufficient renal function. Freedom from recurrent RAOOD (>70%) was achieved in 90.1% of the surgical group and 79.9% of the interventional group. CONCLUSION Both treatment modalities showed good early results concerning RVH, kidney function, and renal perfusion. Despite a higher number of bilateral renal artery reconstructions in patients undergoing OSRP, which was probably due to the preferred technique of transaortic endarterectomy eliminating the plaque originating in the aorta and usually extending into both renal arteries, mortality was not higher and procedure-related morbidity was even lower compared to PTRA + stent. These findings and also longer durability of OSRP imply that surgical reconstruction remains the gold standard for patients with RAOOD before PTRA + stent may be considered.

Current practice of first-line treatment strategies in patients with critical limb ischemia.

OBJECTIVE Critical limb ischemia (CLI) is growing in global prevalence and is associated with high rates of limb loss and mortality. However, a relevant gap of evidence about the most optimal treatment strategy still exists. The aim of this study of the prospective, multicenter First-Line Treatments in Patients With Critical Limb Ischemia (CRITISCH) registry was to assess the current practice of all first-line treatments strategies in CLI patients in German vascular centers. METHODS Between January 2013 and September 2014, five first-line treatment strategies-endovascular revascularization (ER), bypass surgery (BS), femoral/profundal artery patchplasty (FAP), conservative treatment, and primary amputation-were determined among CLI patients in 27 vascular tertiary centers. The main composite end point was major amputation or death, or both, during the hospital stay. Secondary outcomes were hemodynamic failure, major adverse cardiovascular and cerebral events, and reintervention. Univariate logistic models were additionally built to preselect possible risk factors for either event, which were then used as candidates for a multivariate logistic model. RESULTS The study included 1200 consecutive patients. First-line treatment of choice was ER in 642 patients (53.4%), BS in 284 (23.7%), FAP in 126 (10.5%), conservative treatment in 118 (9.8%), and primary amputation in 30 (2.5%). The composite end point was met in 24 patients (4%) after ER, in 17 (6%) after BS, in 8 (6%) after FAP, and in 9 (8%) after conservative treatment (P = .172). The highest rate of in-hospital death was observed after primary amputation (10%) and of hemodynamic failure after conservative treatment (91%). Major adverse cardiovascular and cerebral events developed in 4% of patients after ER, in 5% after BS, in 6% after FAP, in 5% after conservative treatment, and in 13% after primary amputation. The reintervention rate was 8%, 14%, 6%, 5%, and 3% in each group, respectively. In the multivariate regression model, coronary artery disease (odds ratio [OR], 2.96; 95% confidence interval [CI], 1.42-6.17) and previous myocardial infarction (PMI) <6 months (OR, 3.67, 95% CI, 1.51-8.88) were identified as risk factors for the composite end point. Risk factors for amputation were dialysis (OR, 3.31, 95% CI, 1.44-7.58) and PMI (OR, 3.26, 95% CI, 1.23-8.36) and for death, BS compared with ER (OR, 3.32; 95% CI, 1.10-10.0), renal insufficiency without dialysis (OR, 6.34; 95% CI, 1.71-23.5), and PMI (OR, 7.41; 95% CI, 2.11-26.0). CONCLUSIONS The CRITISCH registry revealed ER as the most common first-line approach in CLI patients. Coronary artery disease and PMI <6 months were independent risk factors for the composite end point. Special attention should be also paid to CLI patients with renal insufficiency, with or without dialysis, and those undergoing BS.

Surgical Treatment for Agenesis of the Vena Cava: A Single-centre Experience in 15 Cases

OBJECTIVE Agenesis of the inferior vena cava (IVC) is a rare vascular malformation. Deep vein thrombosis (DVT) and bilateral pelvic thrombosis develop quite frequently, making surgical therapy necessary. PATIENTS AND METHODS Between 1982 and 2006, 15 patients (nine male, six female, mean age 28 standard deviance 9 years) with agenesis of the IVC (IVCA) were treated surgically because of acute or subacute DVT. These patients underwent bilateral transfemoral ante- and retrograde thrombectomy of the iliofemoral and sometimes popliteal veins and replacement of the IVC with an external ring supported PTFE-graft. Bi- or unilateral arteriovenous fistulae were created in the femoral region. The fistulae were closed, on average, 8 months after trans-arterial venography was performed. These patients were examined clinically and by duplex ultrasound imaging during follow-up to assess graft patency and to allow CEAP classification. Patients were assessed for the development of post-thrombotic syndrome (PTS). RESULTS No patient died during any part of their treatment or within 60 days. Primary patency of the venous reconstruction was 53%, secondary and long time follow-up patency was 83%. The mean duration of follow-up was 41 SD 12 months. Minor complications were observed in five cases (33%). PTS showed no progression during a follow-up of 41 SD 12 months in all patients. There was no change in the CEAP clinical stage during follow-up nor did any leg ulcer develop. CONCLUSION A surgical approach to restore venous patency is effective and appears to prevent the deterioration of CVI over time.

Renal Cysts in Living Donor Kidney Transplantation: Long-Term Follow-up in 25 Patients

INTRODUCTION The acceptance of a living donor kidney bearing cysts might implicate complications after the transplantation due to the natural history of renal cysts. We have presented our experience with transplantation of living donor kidneys containing cysts but not polycystic disease. PATIENTS AND METHODS We retrospectively reviewed donor and recipient records of all living kidney transplants performed between January 1997 and April 2008. We analyzed serum creatinine and urea levels, as well as ultrasound scans concerning cyst size and morphology at hospital discharge as well as at 12 and 24 months after transplantation. RESULTS Among 268 living kidney transplantations, we noted 25 donors with renal cysts. In the computed tomography scan reports, 19 kidneys were described to show a single and six, multiple cysts. The size of 10 single cysts was <5 mm; the other nine were a mean of 17.33 mm. Two of the multiple cyst kidneys had lesions <5 mm; in four kidneys, the mean cyst size was 27.25 mm. The renal function of the recipients was normal or almost normal at discharge with a tendency to lower levels at 12 and 24 months after transplantation. Ultrasound revealed changes in cyst diameter among 6/23 kidneys; the mean diameter increased after 12 months, namely, 8.25 mm to 11.5 mm after 24 months. The subgroup of patients with enlarged cysts showed creatinine and urea levels slightly higher than in the entire group. No aspects of malignancy were found, according to the Bosniak and Israel classification system. One suspicious cyst was tomographically confirmed to be hemorrhagic without any need for treatment. None of the living donors had any problems related to the donor nephrectomy or a need for dialysis due to renal insufficiency in the long term. In addition, the living donors who had even beforehand cystic lesions in their contralateral nonremoved kidney at the time of transplantation did not show complications upon follow-up. CONCLUSIONS In our study, 25 living donor kidneys carried cysts. Neither cyst-related complications nor dysfunction of the transplanted organs occurred. An unroofing or excision of the cyst was generally not necessary. Regular ultrasound scans and optional computed tomography scans are recommended for follow-up. Based on this experience, we concluded that kidneys presenting cystic diseases should be considered to be suitable for transplantation without a hazard to the recipients, thus extending the pool of organs.

Early and long-term results after reconstructive surgery in 42 children and two young adults with renovascular hypertension due to fibromuscular dysplasia and middle aortic syndrome.

OBJECTIVES This retrospective study presents the early and late results of pediatric patients who underwent reconstructive surgery for renovascular hypertension (RVH) between 1979 and 2009. METHODS From 1979 to 2009 44 patients (male 22; mean age 13±5.2 years, range 1-19 years; early childhood 7 [1-6 years], middle childhood 5 [7-10 years]; adolescents 32 [11-19 years]) with renovascular hypertension underwent surgery for abdominal aortic stenoses (n=6), renal artery stenosis (RAS) (n=25) or for combined lesions (n=13). Nineteen aortic stenoses (bypass/interposition 10/5, patch dilatation/thromboendarterectomy 2/2), 51 renal arteries (interposition 36, resection+reimplantation 13, patch dilatation/aneurysmorraphy 1 each), and 10 visceral arteries (resection+reimplantation 6, interposition 3, patch dilatation 1) were reconstructed. Each patient underwent duplex studies and if required intra-arterial digital subtraction angiography. Reoperations within 30 postoperative days were required in four (9%) of the patients for occlusion of four arteries (6%), achieving a combined technical success rate of 94%. RESULTS After 114±81 months 36 patients were re-examined by duplex and magnetic resonance angiography (2 not surgery-related deaths 7/12 years postoperatively, 8 patients lived abroad). Twelve patients had required a second and three a third procedure. Hypertension was cured early/late postoperatively in 27%/56%, improved in 41%/44%, and remained unchanged in 32%/0%. Best late results were obtained in patients with isolated aortic disease and at the age of middle childhood. CONCLUSIONS Reconstructive surgery for pediatric RVH yields good results at every age and every type of lesion. However, these children should be followed up closely and to avoid early cardiovascular disease and death in later life, surgery should not be delayed.

Association between statin therapy and amputation-free survival in patients with critical limb ischemia in the CRITISCH registry

Objective Secondary prevention in patients with critical limb ischemia (CLI) is crucial for the reduction of cardiovascular morbidity and mortality. Nonetheless, current recommendations are extrapolated from other high‐risk populations because of the lack of CLI‐dedicated trials. The aim of this explorative study was to evaluate the association of statin therapy with the outcomes of CLI patients. Methods The First‐Line Treatments in Patients With Critical Limb Ischemia (CRITISCH) registry is a prospective multicenter registry analyzing the effectiveness of all available treatment strategies in 1200 CLI patients. For the purposes of this analysis, patients were divided into two groups based on statin administration. Treatment crossovers and nonadherent patients were excluded from analysis. The primary composite end point of this study was the amputation‐free survival (AFS). Major adverse cardiovascular and cerebral events (MACCEs), time to death, and time to major amputation were also analyzed. Results Statin therapy was applied in 445 individuals (37%), 371 (31%) patients received no statins, and 384 subjects were excluded from analysis (treatment crossovers). Patients receiving statins were more likely to be younger (P < .001) and to have a history of coronary heart disease (P < .001) or previous intervention at index limb (P < .001). Patients receiving statin therapy had a lower hazard regarding AFS (hazard ratio [HR], 0.45; 95% confidence interval [CI], 0.34‐0.63; P < .001) and death (HR, 0.40; 95% CI, 0.24‐0.66; P < .001) as well as lower odds of MACCE (odds ratio, 0.41; 95% CI, 0.23‐0.69; P = .001). However, statin therapy was not associated with reduced amputation rates (HR, 1.02; 95% CI, 0.67‐1.56; P = .922). Statin effect on AFS was consistent among diabetics (HR, 0.47; 95% CI, 0.31‐0.70; P < .001), patients with chronic kidney disease (HR, 0.53; 95% CI, 0.32‐0.87; P = .012), and patients older than 75 years (HR, 0.40; 95% CI, 0.26‐0.60; P < .001). Statin administration was also associated with an improved AFS in patients with antiplatelet medication (HR, 0.64; 95% CI, 0.41‐0.99; P = .049) and without antiplatelet medication (HR, 0.26; 95% CI, 0.12‐0.57; P = .001) and after both endovascular therapy (HR, 0.51; 95% CI, 0.34‐0.76; P = .001) and bypass revascularization (HR, 0.38; 95% CI, 0.21‐0.68; P = .001). Conclusions Statin therapy in CLI patients is associated with an increased AFS and lower rates of mortality and MACCEs without improving, however, the salvage rates of the affected limb.

One-Year Results of First-Line Treatment Strategies in Patients With Critical Limb Ischemia (CRITISCH Registry):

Purpose: To examine the outcomes of all first-line strategies for the treatment of critical limb ischemia (CLI), identify factors that influenced the treatment choice, and determine the risk of amputation or death after each treatment. Methods: CRITISCH (ClinicalTrials.gov identifier NCT01877252) is a multicenter, national, prospective registry evaluating all available treatment strategies applied in 1200 consecutive CLI patients in 27 vascular centers in Germany. The recruitment started in January 2013 and was completed in September 2014. Treatment options were endovascular revascularization (642, 53.5%), bypass surgery (284, 23.7%), femoral artery patchplasty (126, 10.5%) with or without concomitant peripheral intervention, conservative treatment (118, 9.8%), and primary major amputation (30, 2.5%). The primary endpoint of this study was amputation-free survival (AFS). The Society of Vascular Surgery’s suggested objective performance goal (OPG) for AFS (71%) was used as the effectiveness criterion. Multivariable regression methods were employed to identify variables that influenced the treatment selection and AFS after each treatment; results are presented as the hazard ratio (HR) and 95% confidence interval (CI). Results: The 12-month AFS estimates following endovascular therapy, bypass grafting, femoral patchplasty, and conservative treatment were 75%, 72%, 73%, and 72%, respectively. Factors influencing treatment choice were age, chronic kidney disease (CKD), diabetes, smoking, prior vascular procedures in the index leg, TransAtlantic Inter-Society Consensus II C/D lesions, and absence of runoff vessels. Cox regression analysis identified CKD (HR 2.07, 95% CI 1.26 to 3.41, p=0.004), the use of a prosthetic bypass conduit (HR 1.97, 95% CI 1.23 to 3.14, p=0.004), and previous vascular intervention in the index limb (HR 1.52, 95% CI 0.94 to 2.43, p=0.085) as independent risk factors for diminished AFS after bypass surgery. CKD (HR 1.47, 95% CI 1.09 to 1.99, p=0.012) and Rutherford category 6 (HR 1.81, 95% CI 1.30 to 2.52, p<0.001) compromised the performance of endovascular revascularization. Conclusion: CRITISCH registry data revealed that all first-line treatment strategies selected and indicated by the treating physicians met the suggested OPGs. CKD was an important determinant of patient prognosis after treatment regardless of the revascularization method.

Vena-cava-Filter: Fakten und Trends

PCT No. PCT/GB95/01408 Sec. 371 Date Dec. 13, 1996 Sec. 102(e) Date Dec. 13, 1996 PCT Filed Jun. 16, 1995 PCT Pub. No. WO95/34339 PCT Pub. Date Dec. 21, 1995A vena-cava filter features an inflatable balloon at or near the distal end of an elongate flexible multiple-lumen core or stem. The balloon is suitably configured in a preferred construction at or near the distal end of an elongate flexible multiple-lumen core. The balloon is suitably configured in a preferred embodiment for femoral-vein insertional installation; and in another embodiment the balloon is suitably configured for jugular-vein insertional installation. In both embodiments, the balloon is deflated prior to insertion; it is inflated to become a filter when properly positioned in the vein, and finally it is deflated for removal purposes. Installation may proceed pursuant to guide-wire techniques commonly used for catheter installation. Each of the indicated two embodiments is described for the case of additionally providing for injection of a tracer or a thrombolytic agent at a location in the vein at proximal (i.e., upstream) offset from the region of filter action.

Outcomes of dialysis patients with critical limb ischemia after revascularization compared with patients with normal renal function

Objective An analysis was conducted of intermediate outcomes and possible influencing factors in patients with end‐stage renal disease (ESRD) and critical limb ischemia after lower limb revascularization compared with patients with regular renal function (non‐ESRD). Methods Data collection was performed by inquiry of the German multicenter registry of First‐Line Treatments in Patients with Critical Limb Ischemia (CRITISCH); 102 ESRD patients and 674 non‐ESRD patients were included. Four different therapy modalities were analysed: bypass surgery, endovascular therapy (EVT), femoral artery endarterectomy, and no vascular intervention (conservative treatment or primary major amputation). Predefined end points were amputation‐free survival (AFS), death, major amputation, and reintervention. Cox regression models were built to analyze independent risk factors for outcome parameters. Results ESRD patients showed inferior results at 2 years in the rate of AFS (ESRD, 35.4%; non‐ESRD, 67.2%; P < .001). Similarly, death rate (ESRD, 55.0%; non‐ESRD, 20.7%; P < .001) and major amputation rate (ESRD, 24.5%; non‐ESRD, 15.8%; P = .029) were significantly elevated for ESRD patients. The choice of therapeutic approach in ESRD did not influence the incidence of the investigated end points (death or major amputation: EVT, 56.9% vs bypass, 76.9% [P = .225]; death: EVT, 46.2% vs bypass, 61.5% [P = .372]; amputation: EVT, 15.4% vs bypass, 15.4% [P = 1.000]; reintervention: EVT, 32.3% vs bypass, 15.4% [P = .324]). Cox regression analysis indicated that dialysis patients carry a twofold increased hazard of death or major amputation (hazard ratio, 2.27; 95% confidence interval, 1.67‐3.10; P < .001), and open surgical treatment (all patients combined) was associated with reduced risk of death compared with EVT (hazard ratio, 0.58; 95% confidence interval, 0.37‐0.91; P = .017). Comorbidities were not found to have a noticeable impact on AFS, survival, reintervention, or major amputation. Conclusions Two‐year AFS, overall survival, and freedom from major amputation were decreased in ESRD patients compared with non‐ESRD patients with critical limb ischemia. Cardiovascular comorbidities were without significant impact on outcome parameters, whereas choice of treatment modality within the ESRD group did not influence AFS. Decision‐making in ESRD as to choice of therapeutic approach in dialysis patients should notably account for the individuals lesion characteristics and vascular disease; surgical revascularization and EVT may be used as complementary options.

Outcomes After Endovascular Revascularization in Octogenarians and Non-Octogenarians With Critical Limb Ischemia

Purpose: To determine the outcome and periprocedural risk of endovascular revascularization in octogenarians with critical limb ischemia (CLI) compared with their younger counterparts. Methods: The multicenter, prospective registry for First-line Treatments in Patients With Critical Limb Ischemia (CRITISCH) enrolled 642 patients treated with endovascular techniques ( ClinicalTrials.gov identifier NCT01877252). The patients were dichotomized according to age <80 years (n=421; mean age 69 years, 292 men; group 1) or ≥80 years (n=221; mean age 85 years, 113 men; group 2). The groups had similar distributions in Rutherford categories 4 to 6, but group 1 had more men, smokers, diabetics, and patients on dialysis. The primary composite endpoint of the study was amputation and/or death. Key secondary endpoints were in-hospital mortality and major amputation, as well as major adverse limb events (MALE; any reintervention or major amputation involving the index limb) at 1 year. Results: The in-hospital mortality was 1% in group 1 and 2% in group 2 (p=0.204) and the major amputation rates were 4% and 2% (p=0.169), respectively. Amputation-free survival at 1 year was 75% in group 1 and 77% in group 2 (p=0.340), whereas freedom from MALE was significantly different between the groups [62% group 1 vs 72% group 2; hazard ratio (HR) 1.45, 95% confidence interval (CI) 1.09 to 1.93, p=0.016). Limb salvage was 90% in group 1 and 95% in group 2 (HR 2.16, 95% CI 1.27 to 3.69, p=0.01). Conclusion: Octogenarians with CLI treated by endovascular means showed comparable early and 1-year amputation-free survival rates vs their younger counterparts, and limb salvage and freedom from MALE rates were even higher in octogenarians.