The degree of permanent pacemaker dependence and clinical outcomes following transcatheter aortic valve implantation: implications for procedural technique.

Aims: Conduction abnormalities necessitating permanent pacemaker (PPM) implantation remain the most frequent complication post-transcatheter aortic valve implantation (TAVI), yet reliance on PPM function varies. We evaluated the association of right-ventricular (RV)-stimulation rate post-TAVI with 1-year major adverse cardiovascular events (MACE) (all-cause mortality and heart failure hospitalization). Methods and results: This retrospective cohort study of patients undergoing TAVI in two high-volume centers included patients with existing PPM pre-TAVI or new PPM post-TAVI. There was a bimodal distribution of RV-stimulation rates stratifying patients into two groups of either low [≤10%: 1.0 (0.0, 3.6)] or high [>10%: 96.0 (54.0, 99.9)] RV-stimulation rate post-TAVI. Hazard ratios (HR) and 95% confidence intervals (CI) were calculated comparing MACE in patients with high vs. low RV-stimulation rates post-TAVI. Of 4659 patients, 408 patients (8.6%) had an existing PPM pre-TAVI and 361 patients (7.7%) underwent PPM implantation post-TAVI. Mean age was 82.3 ± 8.1 years, 39% were women. A high RV-stimulation rate (>10%) development post-TAVI is associated with a two-fold increased risk for MACE [1.97 (1.20, 3.25), P = 0.008]. Valve implantation depth was an independent predictor of high RV-stimulation rate [odds ratio (95% CI): 1.58 (1.21, 2.06), P=<0.001] and itself associated with MACE [1.27 (1.00, 1.59), P = 0.047]. Conclusion: Greater RV-stimulation rates post-TAVI correlate with increased 1-year MACE in patients with new PPM post-TAVI or in those with existing PPM but low RV-stimulation rates pre-TAVI. A shallower valve implantation depth reduces the risk of greater RV-stimulation rates post-TAVI, correlating with improved patient outcomes. These data highlight the importance of a meticulous implant technique even in TAVI recipients with pre-existing PPMs.

Comparison of collagen-based vascular closure devices in patients with vs. without severe peripheral artery disease.

PURPOSE: To compare complication rates of a collagen-based vascular closure device (VCD) in patients with vs. without significant peripheral artery disease (PAD). METHODS: A total of 382 patients (268 men; mean age 64.6±10.8 years) undergoing either an endovascular procedure of the lower limb (PAD group, n=132) or a percutaneous coronary intervention (PCI group, n=250) via a common femoral artery access were enrolled in this prospective study if hemostasis was achieved using the collagen-based Angio-Seal. In the PCI group, significant PAD was excluded by measurement of the ankle-brachial index. In-hospital major complications (bleeding, large hematoma, pseudoaneurysm, vessel occlusion, dissection) were recorded. RESULTS: Similar and low rates of major complications were observed in both arms of the study: 2 (1.5%) major complications in the PAD group and 3 (1.2%) in the PCI group (p=1.0). There was no significant difference in efficacy of the VCDs in the groups (PAD group 99.2% vs. 100% in PCI group, p=0.35). CONCLUSION: Our study shows no significant differences in the rate of major complications after utilization of a collagen-based VCD for femoral artery access site closure in patients with severe lower limb PAD compared to those without; however, complications in the PAD group tended to be more severe, with the need for surgical repair.

Endovascular stent-graft treatment of penetrating aortic ulcer: results over a median follow-up of 27 months.

BACKGROUND: Penetrating aortic ulcer (PAU) is increasingly acknowledged as a pathological variant of classic false-lumen aortic dissection with a high incidence of bleeding complications and rupture in up to 40% of patients. The objective of this study was to investigate the results of endovascular stent-graft placement for the treatment of patients with PAUs. METHODS: Between July 1999 and December 2004, endovascular stent-graft repair of PAU was performed in 22 patients (69.1 +/- 7.8 years, 16 men), 3 (14%) of whom had contained aortic rupture. Stent-graft placement was performed in the cardiac catheterization laboratory with the patient under general anesthesia, using a surgical access. RESULTS: Procedural success was achieved in all but 1 patient (technical success rate 96%). Postoperatively, 1 (5%) patient had minor stroke with transient amentia. There were no other inhospital complications or deaths. During a median follow-up of 27 (range 1-62) months, 1 patient underwent adjunctive stent-graft placement for type I endoleak. Three patients died unrelated to the aortic disease late during follow-up. Overall survival rates were 100% at 30 days, 100% at 1 year, 82.5% +/- 11.3% at 2 years, and 61.9% +/- 20.0% at 5 years. CONCLUSIONS: Endovascular stent-graft treatment is an effective treatment for patients with PAU and is associated with low procedural morbidity. Both acute and midterm mortality of this novel treatment concept appear to be favorable compared with the natural course of the disease.

Endovascular stent-graft placement for acute and contained rupture of the descending thoracic aorta.

OBJECTIVES: To identify determinants of postinterventional death after endovascular stent-graft placement for acute rupture of the descending thoracic aorta, an emerging therapeutic modality for this highly life-threatening condition. METHODS: Between July 1999 and November 2004, 17 patients (14 males; mean age, 65+/-16 (25-83) years) underwent stent-graft repair of the descending thoracic aorta for acute rupture from a thoracic aneurysm (TAA, n=6), acute aortic dissection (AAD, n=6), penetrating aortic ulcer (PAU, n=3), or blunt chest trauma (n=2). Immediate, 30-day, 1-year, and 3-year mortality was assessed. Twenty-one clinical and procedural variables were evaluated in a post-hoc analysis regarding their influence on mortality. Of these, four preprocedural factors with the greatest impact were used to construct a rupture score with a scale from 0 (no adverse prognostic factors present) to 4 (all four adverse factors present). RESULTS: Stent-graft placement was technically feasible in all patients. Complete exclusion of the ruptured aortic pathology could be achieved in only 11 (65%) patients, despite implantation of 1.6+/-0.9 stent-grafts per patient, with a median length of 130 mm. There was one procedure-related early complication (bleeding at the access site). One patient died immediately following the procedure because of progressive mediastinal hematoma, although the rupture site was effectively sealed. Overall survival rates were (76.5+/-10.3)% at 30 days and (52.9+/-12.1)% at 1 year and remained at (52.9+/-12.1)% at 3 years. The four most important preprocedural denominators of death were (1) TAA or AAD as the underlying etiology of aortic rupture (P=0.024), (2) maximum aortic diameter>5 cm (P=0.024), (3) presence of mediastinal hematoma (P=0.056), and (4) an estimated lesion length requiring >1 stent-graft to be covered (P=0.009). Furthermore, residual leakage at the conclusion of the procedure (P=0.009), postprocedural need for dialysis (P=0.004), and prolonged ventilation (P=0.043) were significantly associated with postprocedural death. Using a threshold of >or=3, the rupture score constructed on the basis of the four preprocedural denominators of death was found to be well suited to discriminate postprocedural death (1-year survival: (20.0+/-12.7)% in patients with a rupture score>or=3 vs. 100% in patients with a rupture score<3, P=0.001). CONCLUSION: Endovascular stent-graft placement in patients with acute aortic rupture was technically feasible, albeit still associated with high mortality. A simple risk score constructed in retrospect, on the basis of preprocedural prognostic factors, appeared to provide a useful separation of candidates who are likely to benefit from a straightforward endovascular procedure and should be tested prospectively in future studies.