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Biomedical subjects

David Hildick-Smith

Publications and source records attributed to David Hildick-Smith.

5 recordsLinked to original sources
PubMed2006

BioSTAR Evaluation STudy (BEST): a prospective, multicenter, phase I clinical trial to evaluate the feasibility, efficacy, and safety of the BioSTAR bioabsorbable septal repair implant for the closure of atrial-level shunts.

BACKGROUND: The use of permanent synthetic implants to close atrial septal defects (ASD) and patent foramen ovale (PFO) has a number of limitations, including late complications and the limiting of transeptal access to the left heart should it be required for the later treatment of acquired heart disease. BioSTAR is a novel, bioabsorbable, atrial septal repair implant. This phase I pilot study evaluates the feasibility, safety, and effectiveness of BioSTAR for the first time in humans. METHODS AND RESULTS: We conducted a prospective, open-label, multicenter clinical study in 58 patients aged 28 to 68 years who had a clinically significant ASD or PFO. Percutaneous shunt closure was undertaken with the BioSTAR septal repair implant. Successful device implantation was achieved in 57 (98%) of 58 patients. Closure at 30 days and 6 months, assessed by contrast transthoracic echocardiography, was 48 (92%) of 52 and 54 (96%) of 56, respectively. There was no evidence of a clinically significant response to the device. Transient atrial arrhythmia occurred in 5 patients after implantation. No major safety issues were observed. CONCLUSIONS: This study demonstrates the feasibility, safety, and effectiveness of BioSTAR for the closure of ASD and PFO in humans with a high rate of early and complete shunt closure. BioSTAR is a novel septal repair implant designed to provide biological closure of atrial-level defects using the patient's natural healing response. Because 90% to 95% of the implant is absorbed and replaced with healthy native tissue, future access to the left atrium may be achieved.

Absorbable Implants↗
PubMed2006

Refractory hypoxemia after mitral valve surgery: an unusual cause and its successful percutaneous treatment.

We describe the case of a patient who underwent elective mitral valve replacement and whose postoperative progress was complicated by a persistently high inspired oxygen requirement and consequent inability to wean from respiratory support. The reason for this was initially unclear, but transesophageal echocardiography identified the cause as a postoperative iatrogenic atrial septal defect (ASD). This complication was specifically related to the transseptal surgical approach that had been employed. The refractory arterial hypoxemia encountered postoperatively was due to an element of right-to-left shunting across the defect, in the absence of raised pulmonary artery pressures, likely related to a baffle-like effect of the residual atrial septal tissue. This postulated mechanism was supported both by Doppler color flow mapping across the defect at transesophageal echocardiography, and later by observing a rise in systemic arterial oxygen saturations immediately after device closure of the ASD. Once the iatrogenic ASD had been diagnosed, there was a consensus of opinion that the patient was too unwell to survive further open heart surgery. Hence, percutaneous closure of the defect was performed using an Amplatzer occluder device. This was technically successful and led to a marked improvement in the patient's clinical state, subsequent rapid weaning from ventilatory support and later hospital discharge. This case illustrates a rare presentation of an occasional complication of mitral valve surgery. Percutaneously delivered device closure of the ASD proved highly effective in this patient for whom no other options were felt to be feasible.

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PubMed2004

Comparison of transradial and transfemoral approaches for coronary angiography and angioplasty in octogenarians (the OCTOPLUS study).

This prospective multicenter study was conducted to compare the incidence of significant vascular complications delaying hospital discharge after coronary angiography and percutaneous coronary intervention (PCI) between the radial approach (n = 192) and the femoral approach (n = 185) in octogenarians, a rapidly growing population with numerous risk factors for complications. By intention-to-treat analysis, the incidence of vascular complications was found to be significantly less in the radial group (1.6% vs 6.5%, p = 0.03), without any decrease in the efficacy of PCI and only a slight increase in procedure duration for coronary angiography. All vascular complications, except for 1, occurred in patients treated with the transfemoral approach.

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