This investigation demonstrates that, while pregnancy outcomes in teenagers have improved in recent years relative to historical patterns, teenagers face continuing problems requiring special attention by care givers.
While this life-threatening complication is rare, it is important for all who care for obstetric patients to be aware of it and alert to its development. Early recognition is critical given the need to treat affected women expeditiously to help avoid potentially fatal adverse consequences. Prophylactic thiamine supplementation should be considered in the care of gravidas with hyperemesis.
Background
The B‐Laser™ atherectomy system (Eximo Medical, Israel) is a 355 nm solid‐state Nd:YAG short pulse laser for de‐novo and restenotic infrainguinal PAD with enhanced affinity for atheroma and calcified plaque.
Methods
The study was a prospective, single‐arm, multi‐center, international, open‐label study assessing the B‐Laser™ in symptomatic (Rutherford 2 to 4) infrainguinal peripheral artery disease. Primary core lab efficacy was mean reduction in diameter stenosis >20% by the B‐Laser™ catheter alone. Cardiovascular death, major amputation, target lesion revascularization, WIQ, ABI and Rutherford class were obtained at baseline and out to 6 months. Duplex ultrasound patency (PSVR <2.5), was evaluated by Core Lab.
Results
97 (77 in USA) PAD subjects (51 male, mean 70.5 years [range 46–86]) with 107 lesions were treated with B‐Laser™ (average length 5.4 cm [range 1–24], 29.0% infrapopliteal. 77.6% calcification [26.2% severe], 21.5% chronic total occlusions, 20.6% re‐stenotic). Average reduction in residual stenosis post B‐Laser™ alone was 33.6 ± 14.2%. Baseline and final stenosis (post laser and adjunctive therapy) were 85.7 ± 12.2% and 17.7 ± 11.0%, respectively. Duplex patency was 96.8% at 30‐days and 85.6% at 6 months (95.7% 6‐month patency with severe calcification), and did not differ between POBA vs. DCB sub‐groups. ABI, Rutherford category and WIQ all improved. There was one MAE and three TLRs out of 101 lesions. No procedural distal embolization was noted and there were no major device‐related dissections.
Conclusions
Experience with the B‐Laser™ atherectomy system in infrainguinal PAD procedures demonstrates a high level of safety and efficacy for denovo and restenotic infrainguinal arterial lesions.
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