Effect of thrombophilia on clinical outcomes of chronic post-thrombotic patients after iliofemoral stenting with nitinol venous stents.

OBJECTIVE: Thrombophilia is a prothrombotic condition that increases the risk of venous thromboembolism. It is unclear whether the presence of thrombophilia alters the clinical outcomes after deep venous stenting. The aim of the present study was to examine the relationship between thrombophilia and outcomes after stenting for post-thrombotic syndrome. METHODS: Consecutive patients (2012-2017) receiving a nitinol venous stent for chronic post-thrombotic venous occlusive disease with a minimum of 18 months of follow-up in one center using the same anticoagulation protocol were included. The clinical history and thrombophilia testing results were reviewed. The outcomes were stent patency, which was assessed using duplex ultrasonography at 24 hours, 2 and 6 weeks, 3 months, 6 months, and annually thereafter; and reinterventions, which were performed when the stent diameter was <50% or occluded. RESULTS: Of the 136 patients who had undergone intervention, 55 (40%) had had a provoked deep vein thrombosis (DVT) and 81 (60%) had had an unprovoked DVT and had therefore undergone thrombophilia testing. Of the 81 patients, 38 (47%) had had either inherited (n = 19; 50%) or acquired (n = 19; 50%) thrombophilia. Of the 136 patients who had undergone stenting, 68 had required reintervention (50%) during follow-up to maintain stent patency. Of the 55 patients with a provoked DVT, 29 (53%) had required reintervention. Of the 81 patients with an unprovoked DVT, 39 (48%) had required reintervention (P = .420). Of the 38 patients with unprovoked DVT and thrombophilia, 17 (45%) had required reintervention. Of the 43 patients with unprovoked DVT and no thrombophilia, 22 (51%) had required reintervention (P = .766). The cumulative patency rate was 80% for patients with provoked DVT and 88% for those with unprovoked DVT (P = .193). The presence of thrombophilia was not associated with patency loss (92% cumulative patency for patients with thrombophilia and 84% for patients without thrombophilia; P = .307). CONCLUSIONS: Using our anticoagulation protocol, patients with and without thrombophilia had similar clinical outcomes after deep venous stenting and should not be excluded from iliofemoral venous stenting. We found no significant differences in outcomes in conjunction with appropriate postoperative anticoagulation therapy.

Comparison of Outcomes Using the First and Second Generation Cryoballoon to Treat Atrial Fibrillation.

BACKGROUND: Pulmonary vein isolation using cryoballoon ablation is an effective treatment for patients with atrial fibrillation. We sought to compare outcomes with the first and second generation cryoballoon, with the second generation balloon incorporating the Achieve Lasso catheter, in terms of freedom from symptomatic recurrence and major complications. METHODS: The first 200 patients who underwent cryoballoon ablation with the first generation balloon were compared with the first 200 patients using the second-generation balloon. All patients had symptomatic atrial fibrillation and had failed at least one antiarrhythmic drug. The primary efficacy endpoint was freedom from symptomatic recurrence of atrial fibrillation (AF) after a single pulmonary vein isolation (PVI) procedure using the cryoballoon. The primary safety endpoint was major procedural complications. RESULTS: At 12 months, freedom from symptomatic AF after a single procedure in the first generation cohort was 64.3% compared with 78.6% in the second-generation cohort (p = 0.002). At 24 months, freedom from symptomatic AF in the first generation cohort was 51.3% compared with 72.6% in the second-generation cohort (p < 0.001). Procedural time (150 min vs 101 min; p < 0.001) and fluoroscopy time (32.5 min vs 21.4 min; p < 0.001) was lower in the second-generation group. The rate of major complications was comparably low in both groups. CONCLUSIONS: The second-generation cryoballoon was associated with improved freedom from symptomatic AF with reduction in procedure and fluoroscopy time, with a similar low rate of major complications.

Persistent iatrogenic atrial septal defects after pulmonary vein isolation: long-term follow-up with contrast transesophageal echocardiography.

PURPOSE: Pulmonary vein isolation using cryoballoon ablation is an established approach to treating atrial fibrillation. The procedure involves insertion of a 15-Fr sheath into the left atrium across the interatrial septum. This creates an iatrogenic atrial septal defect, which may have important long-term clinical relevance, especially in younger patients. We sought to determine the long-term incidence of these defects and determine the direction of shunt using contrast transesophageal echocardiography. METHODS: Individuals who had undergone a single pulmonary vein isolation procedure were invited to attend for transesophageal echocardiography (TOE). Patients who had undergone more than one procedure involving puncture of the interatrial septum were excluded. The interatrial septum was interrogated using two-dimensional imaging, color flow Doppler, and microbubble contrast study. RESULTS: A total of 27 patients were recruited with a median follow-up time of 553 days from pulmonary vein isolation to TOE. Seven patients had persistent iatrogenic atrial septal defects with three demonstrating right to left shunt either at rest or with Valsalva. There were no reported adverse events during the study period. CONCLUSIONS: Persistent iatrogenic atrial septal defects are relatively common following cryoballoon ablation procedures. Right to left shunting can be observed using microbubble contrast in a subset of patients with iatrogenic atrial septal defect (iASD). Further studies that longitudinally assess shunt fraction, pulmonary artery pressure, and the incidence of paradoxical embolism are needed to better understand the clinical impacts of such defects.

Long Term Follow-up of Pulmonary Vein Isolation Using Cryoballoon Ablation.

BACKGROUND: Cryoballoon ablation is an established catheter-based approach to treating atrial fibrillation (AF). There is little data regarding the long-term efficacy of this approach. METHODS: We enrolled 200 consecutive patients with symptomatic AF who had failed therapy with at least one anti-arrhythmic medication and followed them for five years. The primary efficacy endpoint was symptomatic recurrence of AF after a single cryoballoon ablation procedure. RESULTS: Two hundred patients formed the study group. Median follow-up was 56 months. Following a single procedure, 46.7% of patients with paroxysmal AF remained free of symptomatic recurrence of AF compared to 35.6% of patients with persistent AF. When allowing for repeat ablations, at the end of the follow-up period 53.3% of patients in the paroxysmal group remained free of symptomatic AF compared to 47.5% in the persistent group. The rate of complications was low. CONCLUSIONS: Cryoballoon ablation is an effective catheter-based approach for treating symptomatic AF with a low risk of complications.

Treating atrial fibrillation: pulmonary vein isolation with the cryoballoon technique.

BACKGROUND: Cryoballoon ablation is a recently introduced technique to isolate the pulmonary veins in patients with atrial fibrillation (AF). It can potentially reduce procedural times and serious complications associated with radiofrequency ablation. METHOD: We present data for 200 consecutive patients who underwent cryoballoon ablation for symptomatic AF with a mean follow-up of 16 months. RESULTS: Over 214 procedures that involved cryoballoon technique the mean procedure and fluoroscopy times fell to 130 and 30 min, respectively. 93.6% of pulmonary veins targeted were isolated with the cryoballoon only and 97.7% could be isolated with the addition of a radiofrequency ablation catheter. At one year 70% of patients in the paroxysmal AF group and 59% of patients in the persistent AF group were free from symptomatic recurrence. Three percent of patients experienced phrenic nerve palsy that persisted beyond the procedure. The major complication rate in this study was 0.9%. CONCLUSION: This represents the earliest and largest experience with cryoballoon ablation for AF in Australia. The major complication rate was low with no pulmonary vein stenosis, atrio-oesophageal fistula, stroke or cardiac tamponade in this series. The majority of patients were free from symptomatic recurrence at two years follow up.

Combined bezafibrate and medroxyprogesterone acetate have efficacy without haematological toxicity in elderly and relapsed acute myeloid leukaemia (AML).

Acute myeloid leukaemia (AML) causes life-threatening deficits of functional blood cells that require management using red cell and platelet transfusion and aggressive treatment of neutropenic infections. Current cytotoxic chemotherapy further worsens the problem of reduced haemopoiesis and two-thirds of patients are too frail to tolerate intensive chemotherapy at all. Median survival amongst these patients remains at <3 months emphasizing the urgent need for anti-AML therapies that do not suppress haemopoiesis. Our laboratory studies showed combined Bezafibrate and Medroxyprogesterone acetate (BaP) had activity against AML without toxicity to normal stem cells. Here we report the safety and efficacy of BaP in 20 patients (19 AML, 1 high-risk myelodysplasia) for whom intensive chemotherapy was not an option. No patient exhibited haematological toxicity from BaP. Eleven patients took BaP alone for >4 weeks. One reverted from high risk myelodysplasia and remains transfusion independent after 201 weeks of therapy. Three AML patients gained major haematological improvements for 22-30 weeks; in one, marrow was available to document a partial AML response. Thus, this trial indicates that BaP therapy has potential for treatment of elderly and relapsed AML.