Chronic thromboembolic pulmonary hypertension (CTEPH): Updated Recommendations from the Cologne Consensus Conference 2018.

Chronic thromboembolic pulmonary hypertension (CTEPH) is a subgroup of pulmonary hypertension that differs from all other forms of PH in terms of its pathophysiology, patient characteristics and treatment. For implementation of the European Guidelines on Diagnosis and Treatment of Pulmonary Hypertension in Germany, the Cologne Consensus Conference 2016 was held and last updated in spring of 2018. One of the working groups was dedicated to CTEPH, practical and controversial issues were commented and updated. In every patient with suspected PH, CTEPH or chronic thromboembolic disease (CTED, i.e. symptomatic residual vasculopathy without pulmonary hypertension) should be excluded. Primary treatment is surgical pulmonary endarterectomy (PEA) in a multidisciplinary CTEPH centre. Inoperable patients or patients with persistent or recurrent CTEPH after PEA are candidates for targeted drug therapy. There is increasing experience with balloon pulmonary angioplasty (BPA) for inoperable patients; this option, like PEA, is reserved for specialised centres with expertise in this treatment method.

Drug-Coated Balloon vs. Conventional Balloon Angioplasty in Dialysis Patients With Symptomatic Femoropopliteal Disease　- A Matched Comparison.

BACKGROUND: Recent randomized trials have shown the treatment benefits of use of a drug-coated balloon (DCB) over conventional percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal disease. However, the effectiveness and safety of DCB for dialysis patients remain unclear.Methods and Results:Consecutive dialysis patients, who underwent PTA or DCB for femoropopliteal disease, were assessed retrospectively via 2:1 propensity score matching. Effectiveness and safety endpoints, including binary restenosis, clinically driven target lesion revascularization (CD-TLR), amputations, major adverse cardiac events (MACE), and deaths, were compared between groups. A total of 278 dialysis patients with 339 limbs were eligible for matching: 84 limbs from 77 patients treated with PTA and 46 limbs from 37 patients treated with DCB were compared after matching. Baseline patient and lesion characteristics were not different between groups. Patients treated with DCB had significantly higher rates of freedom from binary restenosis (52.4% vs. 18.6%, P<0.001) and CD-TLR (56.4% vs. 25.9%, P=0.001) at 2 years compared with patients treated with PTA. Both groups had similar outcomes for amputation, MACE, and death. Cox proportional analysis showed that treatment with DCB was independently associated with a reduction of binary restenosis (hazard ratio [HR] 0.368, P=0.001) and CD-TLR (HR 0.390, P=0.004). CONCLUSIONS: This study suggested superior 2-year outcomes using DCB compared with PTA and similar safety profiles in dialysis patients with femoropopliteal disease.

Dual lumen balloon catheter - An effective substitute for two single lumen catheters in treatment of vascular targets with challenging anatomy.

The aim of this study was to describe our experience in the treatment of various pathological conditions of the cranial and spinal blood vessels and hypervascularized lesions using dual lumen balloon catheters. Twenty-five patients were treated with endovascular techniques: two with vasospasm of cerebral blood vessels caused by subarachnoid hemorrhage, one with a hypervascularized metastasis in the vertebral body, two with spinal dural fistula, four with cerebral dural fistula, three with cerebral arteriovenous malformations, and 13 with aneurysms. The dual lumen balloon catheters were used for remodeling of the coil mesh, injection of various liquid embolic agents, particles and nimodipine, for the prevention of reflux and deployment of coils and stents. The diameter of catheterized blood vessels varied from 0.7 mm to 4 mm. Two complications occurred: perforation of an aneurysm in one case and gluing of the tip of balloon catheter by embolic material in another case. All other interventions were uneventful, and therapeutic goals were achieved in all cases except in the case with gluing of the tip of balloon catheter. The balloons effectively prevented reflux regardless of the type of the embolic material and diameter of blood vessel. The results of our study show that dual lumen balloon catheters allow complex interventions in the narrow cerebral and spinal blood vessels where the safe use of two single lumen catheters is either limited or impossible.

Balloon angioplasty versus stenting for pulmonary vein stenosis after pulmonary vein isolation for atrial fibrillation: A meta-analysis.

BACKGROUND: The incidence of pulmonary vein stenosis (PVS) as complication after pulmonary vein isolation (PVI) for atrial fibrillation (AF) has decreased in the last decade. However, as PVI for AF is becoming more prevalent, the incidence remains considerable in absolute terms. The purpose of this meta-analysis is to investigate the optimal approach for management of PVS after PVI for AF. METHODS AND RESULTS: We searched electronic scientific databases for studies comparing plain balloon angioplasty (BA) versus stenting for PVS after PVI for AF. Aggregate data were pooled to perform a meta-analysis. The primary and secondary outcomes were restenosis requiring repeated intervention and procedure-related complications, respectively. A total of 4 studies, treating 315 PVS in 188 patients (BA, n=171 versus stent, n=144 PVS) were considered. After a median follow-up of 32months, the overall incidence of restenosis was 46%. A percutaneous therapy with BA was associated with a higher risk for restenosis requiring repeat intervention compared to stent (risk ratio - RR, 95% confidence interval [95% CI]=2.18 [1.64-2.89], p<0.001). Procedure-related complications were comparable between BA and stent (RR [95% CI]=0.96 [0.19-4.96], p=0.96). The time to diagnosis of PVS after PVI for AF did not modify the treatment effect for the primary outcome with BA versus stent (p for interaction=0.16). CONCLUSIONS: In patients presenting PVS after PVI for AF, a percutaneous therapy with BA is associated with higher risk for restenosis requiring repeat intervention as compared to stent. These percutaneous therapies display comparable safety.

Improvement in Quality of Life and Hemodynamics in Chronic Thromboembolic Pulmonary Hypertension Treated With Balloon Pulmonary Angioplasty.

BACKGROUND: The effect of balloon pulmonary angioplasty (BPA) on improvement in functional and hemodynamic parameters in chronic thromboembolic pulmonary hypertension (CTEPH) is known, but the quality of life (QoL) of patients treated with BPA has never been studied before.Methods and Results:Twenty-five patients with inoperable or persistent CTEPH were enrolled in the study and filled out the 36-item Short Form (SF-36v2) questionnaire twice: prior to commencement of BPA treatment and after ≥3 BPA sessions. In addition WHO functional class, distance on the 6-min walk test (6MWT) and hemodynamic parameters such as right atrial pressure (RAP), mean pulmonary artery pressure (mPAP), cardiac index (CI) and pulmonary vascular resistance (PVR) were assessed. QoL improved significantly in all domains, except for physical pain. Improvement in RAP (10.5±3.4 vs. 6.2±2.2 mmHg; P<0.05), mPAP (51.7±10.6 vs. 35.0±9.1 mmHg; P<0.05), CI (2.2±0.5 vs. 2.5±0.4 L/min·m2; P=0.04), PVR (10.4±3.9 vs. 5.5±2.2 Wood units; P<0.05), functional class (96% vs. 20% in WHO class III and IV, P<0.05) and improvement in 6MWT distance (323±135 vs. 410±109 m; P<0.05) was observed. The only significant correlation was between the mental component summary score of QoL after completion of treatment and percentage improvement in the 6MWT (-0.404, P<0.05). CONCLUSIONS: Alongside improvement in functional and hemodynamic parameters, BPA also provides significant improvement in QoL.

What Is the Acute Antral Lesion Size After Pulmonary Vein Isolation Using Different Balloon Ablation Technologies?

BACKGROUND: Clinical outcome after pulmonary vein isolation (PVI) may be linked to both durability of PVI and the antral lesion size. Data on balloon-guided technologies are scarce. We investigated the size of the isolated surface area (ISA) acutely after PVI achieved by cryoballoon (CB) or laser balloon (LB), both using voltage mapping.Methods and Results:In 40 patients (73% male, mean age 66±9 years), a bipolar voltage map before and after PVI in sinus rhythm was acquired to delineate the isolated antral surface area (IASA, contiguous area of low voltage <0.5 mV) and the ISA (relative size of the low-voltage area in relation to the whole antral surface area including the posterior wall). IASA (CB: 57±14 cm2vs. LB: 42±15 cm2; P=0.002) as well as ISA (65±8% vs. 54±10%; P=0.001) were significantly larger in the CB than in the LB group. No periprocedural complications occurred. During a mean follow-up of 326±142 days, 4/20 and 5/20 patients experienced an AF/AT recurrence in the CB and LB groups, respectively. No differences in clinical outcome were observed between patients with a large (≥55%) or small (<55%) ISA. CONCLUSIONS: Balloon-guided PVI is associated with antral lesion formation. CB-guided PVI is associated with the largest ISA as compared with LB procedures. ISA size did not correlate with clinical outcome after a single procedure in the present study population.

Asymptomatic carotid artery stenosis: who should be screened, who should be treated and how should we treat them?

Although stopping smoking, lowering blood pressure and reducing lipid levels will reduce global stroke risk and cardiovascular mortality, these remain leading causes of death and disability especially in ageing populations. Further prevention strategies are needed and, in the first part of this review, we explore the potential benefits of appropriate screening for carotid artery disease to reduce stroke and identify those who may have related cardiac disease. Although whole-population carotid screening is an inefficient and costly means of identifying candidates with tight carotid stenosis who might warrant intervention, it can identify many people with lower levels of stenosis who may benefit from cardiovascular risk-reducing medications. Longer-term benefits and cost-effectiveness of any targeted screening program needs further evaluation. Patients with carotid stenosis are known to be at increased risk of stroke and vascular death. Whilst randomized clinical trials and guidelines have reported stroke hazards and benefits of interventional treatment for carotid stenosis, uncertainty remains about their optimal medical management. In the second part of this review we discuss Level I evidence for medical and surgical treatment of asymptomatic carotid stenosis, reasons for the current lack of consensus on interventional management of these patients and future studies which may help to clarify which groups will (and which will likely not) benefit from interventions.

[Better regulatory framework needed for medical devices]. / Bättre regelverk behövs för medicintekniska produkter - HTA-utredning av läkemedelsavgivande stentar och ballonger vid benartärsjukdom visar på bristerna.

We summarize an HTA report regarding patient values of drug-eluting stents and balloons for treatment of atherosclerotic disease in the lower extremities. We found 17 randomized controlled trials, 4 cohort studies and 13 case series. The total number of studied patients was substantial (about 3,000) but there was a strong heterogeneity regarding site of lesion, symptom pattern, device, drug used and outcome measures, making the analysis difficult and based on relatively small subgroups. We found low certainty of evidence (GRADE ++) for a reduced risk of restenosis in patients with critical ischemia and lesions below the knee, and also a modest beneficial effect on ischemic symptoms in a mixed patient population. However, we also identified a worrying safety signal, with increased risk for amputation in a group of patients with below-the-knee disease and critical ischemia. The results highlight the need for a structured system for validation of medical devices, a system analogous to that currently used for evaluation of new pharmacological products.

Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA.

BACKGROUND: Evidence from large, randomized, controlled peripheral artery disease trials reporting long-term outcomes using drug-coated balloons (DCBs) is limited. Previously, the DCB showed favorable 1-year outcomes compared with conventional percutaneous transluminal angioplasty (PTA), yet durability of the treatment effect with DCBs remains unknown. OBJECTIVES: This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions. METHODS: We enrolled 331 patients with symptomatic (Rutherford 2 to 4) femoropopliteal lesions up to 18 cm in length. Patients were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The 24-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), major adverse events, and quality of life and functional outcomes as assessed by the EuroQOL-5D quality-of-life questionnaire, walking impairment questionnaire, and 6-min walk test. RESULTS: At 24 months, patients treated with DCB showed significantly higher primary patency when compared with PTA (78.9% vs. 50.1%; p < 0.001). The rates of CD-TLR were 9.1% and 28.3% (p < 0.001) for the DCB and PTA groups, respectively. The overall mortality rate in the DCB group was 8.1% versus 0.9% in the PTA group (p = 0.008). There were no device- or procedure-related deaths and no major amputations in either group through 24-month follow-up. The rate of vessel thrombosis was low (1.5% DCB vs. 3.8% PTA; p = 0.243), with no new events reported between 1 and 2 years. Both groups showed similar functional improvement at 2 years, although DCB patients achieved this level of function with 58% fewer reinterventions. CONCLUSIONS: The 24-month outcomes from the trial demonstrate a durable and superior treatment effect of DCB versus PTA with significantly higher primary patency, lower CD-TLR, and similar functional status improvement with fewer repeat interventions. (Randomized Trial of IN.PACT Admiral Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; and IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461).

The impact of feedback of intraoperative technical performance in surgery: a systematic review.

OBJECTIVES: Increasing patient demands, costs and emphasis on safety, coupled with reductions in the length of time surgical trainees spend in the operating theatre, necessitate means to improve the efficiency of surgical training. In this respect, feedback based on intraoperative surgical performance may be beneficial. Our aim was to systematically review the impact of intraoperative feedback based on surgical performance. SETTING: MEDLINE, Embase, PsycINFO, AMED and the Cochrane Database of Systematic Reviews were searched. Two reviewers independently reviewed citations using predetermined inclusion and exclusion criteria. 32 data-points per study were extracted. PARTICIPANTS: The search strategy yielded 1531 citations. Three studies were eligible, which comprised a total of 280 procedures by 62 surgeons. RESULTS: Overall, feedback based on intraoperative surgical performance was found to be a powerful method for improving performance. In cholecystectomy, feedback led to a reduction in procedure time (p=0.022) and an improvement in economy of movement (p<0.001). In simulated laparoscopic colectomy, feedback led to improvements in instrument path length (p=0.001) and instrument smoothness (p=0.045). Feedback also reduced error scores in cholecystectomy (p=0.003), simulated laparoscopic colectomy (p<0.001) and simulated renal artery angioplasty (p=0.004). In addition, feedback improved balloon placement accuracy (p=0.041), and resulted in a smoother learning curve and earlier plateau in performance in simulated renal artery angioplasty. CONCLUSIONS: Intraoperative feedback appears to be associated with an improvement in performance, however, there is a paucity of research in this area. Further work is needed in order to establish the long-term benefits of feedback and the optimum means and circumstances of feedback delivery.

Treatment of peripheral arterial disease in diabetes: a consensus of the Italian Societies of Diabetes (SID, AMD), Radiology (SIRM) and Vascular Endovascular Surgery (SICVE).

Diabetic foot (DF) is a chronic and highly disabling complication of diabetes. The prevalence of peripheral arterial disease (PAD) is high in diabetic patients and, associated or not with peripheral neuropathy (PN), can be found in 50% of cases of DF. It is worth pointing out that the number of major amputations in diabetic patients is still very high. Many PAD diabetic patients are not revascularised due to lack of technical expertise or, even worse, negative beliefs because of poor experience. This despite the progress obtained in the techniques of distal revascularisation that nowadays allow to reopen distal arteries of the leg and foot. Italy has one of the lowest prevalence rates of major amputations in Europe, and has a long tradition in the field of limb salvage by means of an aggressive approach in debridement, antibiotic therapy and distal revascularisation. Therefore, we believe it is appropriate to produce a consensus document concerning the treatment of PAD and limb salvage in diabetic patients, based on the Italian experience in this field, to share with the scientific community.

Outcomes of infrapopliteal endoluminal intervention for transatlantic intersociety consensus C and D lesions in patients with critical limb ischaemia.

BACKGROUND: Recent data suggest that infrapopliteal percutaneous transluminal angioplasty (PTA) is a reasonable primary therapy for critical limb ischaemia (CLI). Based on the transatlantic intersociety consensus (TASC) classification, this has been found to be true for lesions classified as A, B or C. We report our experience with infrapopliteal PTA stratified by TASC classification. METHODS: A retrospective study of patients who underwent infrapopliteal PTA with or without stenting from October 2007 to July 2011 was conducted, revealing 83 limbs. The primary outcome variables were freedom from reintervention and freedom from index limb amputation. Secondary outcomes were technical success, post-operative complications and survival. TASC classification was assessed for the individual vessel(s) chosen for intervention. RESULTS: Median age was 76 years and radiological success was 86.75%. Average follow-up was 15 months. At 1 and 2 years, freedom from re-intervention, or amputation was 65.1% and 55.6%. Limb salvage was 77.7%. Within 2 years, 2% underwent bypass and 18% repeat infrapopliteal PTA. The 30-day mortality was 5%. Overall survival was 84.5%, 71.8% and 61.6% at 1, 2 and 3 years. Eighty-two per cent were classified as TASC D lesions. Radiological success was achieved in 100% of TASC C lesions in contrast to 86.7% of TASC D lesions. There was not a statistically significant relationship between primary outcomes and TASC D classification. DISCUSSION: Given the encouragingly high rates of radiological success and limb salvage, an attempt at PTA is indicated as an alternative to primary amputation even in patients with radiologically demonstrated severe disease.

Invasive interventional management of post-hemorrhagic cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage.

Current clinical practice standards are addressed for the invasive interventional management of post-hemorrhagic cerebral vasospasm (PHCV) in patients with aneurysmal subarachnoid hemorrhage. The conclusions, based on an assessment by the Standards Committee of the Society of Neurointerventional Surgery, included a critical review of the literature using guidelines for evidence based medicine proposed by the Stroke Council of the American Heart Association and the University of Oxford, Centre for Evidence Based Medicine. Specifically examined were the safety and efficacy of established invasive interventional therapies, including transluminal balloon angioplasty (TBA) and intra-arterial vasodilator infusion therapy (IAVT). The assessment shows that these invasive interventional therapies may be beneficial and may be considered for PHCV-that is, symptomatic with cerebral ischemia and refractory to maximal medical management. As outlined in this document, IAVT may be beneficial for the management of PHCV involving the proximal and/or distal intradural cerebral circulation. TBA may be beneficial for the management of PHCV that involves the proximal intradural cerebral circulation. The assessment shows that for the indications described above, TBA and IAVT are classified as Class IIb, Level B interventions according to the American Heart Association guidelines, and Level 4, Grade C interventions according to the University of Oxford Centre for Evidence Based Medicine guidelines.

[Stent implantation in recoarctation of aorta in infant]. / Wykorzystanie stentu w leczeniu wtórnego zwezenia luku aorty w okresie niemowlecym.

We present the case of a 12 month-old infant with critical coarctaion of aorta, arch hypoplasia, atrial and ventricular septal defects who underwent interventional treatment with stent implantation due to recoarctation of aorta. In neonatal period the patient went through complete surgical correction. At the age of four months balloon angioplasty of recurrent coractation was conducted. Eight months later the patient was hospitalised with heart failure (HF) symptoms. Clinical and echographic examination confirmed critical stenosis of aortic isthmus. We performed heart catheterisation with stent implantation to transverse and descending arch with immediate reduction of gradient from 45 mm Hg to 0 mm Hg, widening of the isthmus from 2 to 8 mm and gradual regression of HF symptoms. At 3 years of observation the patient has not presented with any signs of recurrence of the stenosis. The child remains free of HF symptoms with arterial hypertension controlled with pharmacotherapy and with good left ventricular function on echocardiographic examination.

[Composed angioplasty of the multilevel right common and internal carotid artery stenoses with implantation stents with used of proximal and distal protection system]. / Zlozona angioplastyka prawej tetnicy szyjnej wewnetrznej i wspólnej z implantacja stentów z zastosowaniem równoczesnej protekcji proksymalnej i dystalnej.

We present a case of a 73 year-old man with, long-segment thigh stenosis in the right common and internal carotid artery with occlusion left common carotid artery. Complex angioplasty with modification proximal and distal system protection was successful performed. There were no procedure-related complications. We concluded that in very complex, multilevel lesions in carotid artery, there is a place for safe double system protection. This maneuver can increase safe of the carotid artery stenting and minimise potential complications.

[Carotid endarterectomy versus stenting: where do we stand today?]. / Karotis arter endarterektomisine karsi karotis artere stent: Bugün nerede duruyoruz?

Carotid artery stenosis is the major cause of the stroke associated with ischemic origin and carries increased mortality and morbidity. Since carotid artery endarterectomy (CEA) was first performed in 1950, in conjunction with the advanced technology and increased experience under the guidance of randomized controlled trials, balloon angioplasty and carotid artery stenting, which have similar mortality and morbidity, have become comparable with CEA. Determining the optimal treatment option for each patient is the most important issue in carotid artery stenosis. Today, there have been improvements in technology and recent advances in the cardiovascular sciences. Moreover, there is increased experience, increased attention to patient selection, and a team approach to find the most suitable treatment for the patient. In this review, we briefly discuss the current treatment approaches for carotid artery stenosis under the guidance of the modern studies.

[Carotid endarterectomy or carotid stenting: optimal therapeutic decision-making for patients with carotid artery stenoses].

The work was aimed at comparatively studying the outcomes of carotid endarterectomy and carotid stenting for optimal therapeutic decision-making in patients presenting with carotid artery stenoses. We examined and treated a total of one hundred and sixty-seven patients. In the group of endarterectomy, we performed a total of 91 operations in 85 patients, and in the group of carotid stenting, a total of 87 stenting procedures were carried out on the internal carotid artery with cerebral protection in 82 patients. This was followed by analysing both short- and long-term outcomes with a follow-up period ranging from 1 year to 3 years. We examined the following postoperative parameters: «stroke + lethality¼, incidence of transitory ischaemic attacks, as well as the rate of craniocerebral neuropathy and acute myocardial infarction. In the remote period we evaluated the prevalence rate of the parameter «stroke + myocardial infarction + lethality¼, as well as restenosis recurrence. In the carotid-endarterectomy group, the predictors of unfavourable surgical outcomes were contralateral occlusion (p=0.048) and cardial pathology (p=0.0245). In the group of carotid stenting, these predictors turned out to be a heterogeneous atherosclerotic plaque with an uneven or ulcerated contour (p=0.004), and the degree of cerebrovascular insufficiency (p=0.005).

Comparison of plain balloon and cutting balloon angioplasty for the treatment of restenosis with drug-eluting stents vs bare metal stents.

BACKGROUND: The efficacy of cutting or plain balloon angioplasty (CBA or PBA) has not been analyzed for the treatment of drug-eluting stent (DES) restenosis vs bare metal stent (BMS) restenosis. METHODS AND RESULTS: The 252 in-stent restenosis (ISR) lesions in 224 consecutive patients treated by CBA (n=167) or PBA (n=85) between July 2002 and December 2007 were analyzed. At 6-month angiographic and 12-month clinical follow-up, CBA and PBA showed similar efficacies: repeat-ISR (37.0% vs 37.8%, P=0.90), late loss (0.62+/-0.60 vs 0.61+/-0.47 mm, P=0.92), and target lesion revascularization (18.3% vs 22.4%, P=0.50). This comparable efficacy was maintained for treatment in the DES-ISR and BMS-ISR subgroups. However, target lesion-related myocardial infarction (n=9) occurred more frequently in the CBA than in the PBA arm (6.2% vs 0%, P=0.03), most of which developed early after ISR treatment (n=7; 54+/-26 days). Independent predictors of repeat-ISR were diffuse ISR and smaller pretreatment minimal lumen diameter, both of which might imply heavier plaque burden in the ISR group. CONCLUSIONS: Plain or cutting balloon angioplasty for ISR seems to be comparable, as the angiographic or clinical endpoints were not affected by initial stent type but by parameters related to the plaque burden of the ISR lesion. However, CBA might be associated with higher risk of myocardial infarction than PBA, suggesting more attention to dual-antiplatelet therapy after its use for ISR.