Population characteristics, treatment assignment, and clinical outcome of patients with severe aortic stenosis who were not eligible to participate in a clinical trial evaluation percutaneous aortic valve replacement

Abstracts / Cardiovascular Revascularization Medicine 10 (2009) 195–212 mean age was 68.7 years. The mean duration of the procedure after the initial surgery was 8.3 years (range, 8 months to 19 years). Haemolytic anaemia was a feature in all cases. Percutaneous intervention was the chosen modality due to high surgical risk in three patients, complications during previous surgery in two, and patient preference in one. The patients were evaluated with transthoracic and transesophageal echocardiography (TEE) in all cases. Live three-dimensional TEE was an additional modality used in five cases. Patients had preprocedure cardiac magnetic resonance imaging (MRI) scans in four cases. There was good correlation with the TEE and MRI findings, and both were useful in assessing the paravalvular geometry and suitability for percutaneous closure. There were no deaths or MACE during the procedure. Implantation of the device was technically successful in five out of six patients. One patient had entrapment of the mitral valve replacement lateral disc with the occluder device, which was retrieved percutaneously and patient referred for surgery. One patient had significant residual (though improved) leak post procedure and was operated on 3 weeks later. All patients without MACE at a mean follow-up of 7 months (range, 1–16 months). Conclusions: Transcatheter percutaneous paravalvular leak closure is a technically demanding but feasible procedure. Cardiac imaging using TEE, 3D TEE and MRI allows for accurate evaluation of paravalvular geometry and aid intraprocedural guidance to achieve the best possible results. doi:10.1016/j.carrev.2009.04.042

Population characteristics, treatment assignment, and clinical outcome of patients with severe aortic stenosis who were not eligible to participate in a clinical trial evaluation percutaneous aortic valve replacement Itsik Ben-Dor, Augusto D Pichard, Lowell F Satler, Petros Okubagzi, Rebecca Torguson, Zhenyi Xue, Asmir I Syed, Sara D Collins, Kimberly Kaneshige, William O Suddath, Kenneth M Kent, Ron Waksman Washington Hospital Center, Washington, DC Background: Percutaneous aortic valve replacement (PAVR) is currently evaluated in clinical trial for patients with severe aortic stenosis (AS), who are considered high-risk surgical candidates. However, many patients are not eligible to participate in the trial. The aim of the present study was study the demographics and the outcome of the patients that could not enter the trial. Methods: The study cohort was consisted of 231 patients with severe AS who were referred to participate in the clinical trial of PAVR. All patients were evaluated based on the protocol inclusion/exclusion criteria, and the group deferred from the study was continued to be followed clinically.

Table Characteristics and outcomes of the study population Medically treated (n=61) Age (years) Thoracic surgeons score (%) Logistic EuroSCORE (%) Ejection fraction (%) Aortic valve area (cm2) Mean gradient (mmHg) Mean duration of follow-up (days) Mean time from screening to mortality (days) Mortality (%)

Surgical Balloon aortic valve valvuloplasty replacement (n= 75) (n=35) P

82.3±8.6 11.2±5.6

81.0±9.7 12.1±5.9

81.3±9.2 7.6±5.2

.41 b.001

36.7±23.1

45.0±21.5

19.9±12.3

b.001

50.1±16.6 0.80±0.21 37.5±14.7 185±182

47.6±18.4 0.69±0.12 40.9±12.3 211±192

59.0±11.9 0.71±0.19 48.8±20.8 249±169

b.001 .001 .008 .17

93.8±101.6 122.7±155.1

27.6±27.9

.04

26.2

17.1

.003

41.3

207

Results: Of the 231 patients referred for PAVR, 171 (74.0%) were rejected. The major reasons for rejection were peripheral vascular disease 25.1%, Society of Thoracic Surgeons b10%–21.6%, AVA N0.8 cm2 11.7%, and coronary artery disease 11.1%. This cohort was divided in three: (1) medically treated 35.7%, (2) balloon aortic valvuloplasty (BAV) 43.8%, and (3) surgery 20.5%. There was no difference between groups in the mean age. The STS and EuroSCORE were significantly lower in the surgical group. The mean aortic valve area was higher and the mean gradients were lower in the medically treated group. The ejection fraction was lower in the BAV group. Death was lower in surgical group (Table). Conclusion: Most of the patients refereed for PAVR are not eligible for the procedure mainly due to concomitant peripheral artery disease or failing one or more of the inclusion criteria for the protocol. The mortality among this group is very high with currently available options for treatment. doi:10.1016/j.carrev.2009.04.043

Severity of aortic stenosis, not STS score, predicts procedural mortality in elderly patients undergoing balloon aortic valvuloplasty Michael Anderson, Robert S Schwartz, Christopher Pedersen, Anil K Poulose, Michael R Mooney, Charlene R Boisjolie, Peg Demmer, Timothy D Henry, Wes R Pedersen Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, MN Background: Balloon Aortic Valvuloplasty (BAV) for aortic stenosis is required as an essential step in the delivery of percutaneous aortic valves and, on occasion, is used as stand alone therapy. BAV is not without procedural mortality and requires a better understanding to minimize the risk as these procedures increase in frequency. Methods: Between June 2003 and July 2008, 210 BAVs were performed resulting in 7 (3.3%) procedural mortalities (PMs). Medical records, operative reports, and when available, autopsy findings were reviewed to determine cause of death. Patient and procedural characteristics were analyzed for comparison between PM and non-PM patient groups. Results: PM was determined to be aortic root tear in four patients, electrical mechanical dissociation in one, pulmonary hemorrhage in one, and irreversible hemodynamic collapse of undetermined etiology in the final patient. Abrupt release in residual indentation of the inflated balloon contour at the annulus with progressive inflation beyond moderate resistance was documented on final inflation in three of four aortic root tear patients followed by abrupt hemodynamic collapse. Conclusion: The most common cause of PM following BAV was aortic root dissection. Predictors of PM included measures of AS severity, not Society of Thoracic Surgeons score, left ventricular outflow tract, or balloon diameter. Overly aggressive balloon inflations beyond moderate manual resistance to fully expand residual balloon indentation at the annulus should be avoided, especially in patients with extremely stenotic valves.

Variable Age (years), mean (SD) STS score Pre-BAV LVEF (%) Pre-BAV mean gradient (mmHg) Pre-BAV AVA (cm2) LVOT diameter (mm) Max balloon diameter (mm) No. of inflations doi:10.1016/j.carrev.2009.04.044

PM group (n=7) (mean±SD)

Non-PM group (n=203) (mean±SD)

P

88.3±3.1 11.1±4.6% 53.6±13.7 64.3±20.3

86.8±6.4 12.6±5.7% 49.0±16.6 40±18.8

.55 .36 .58 .051

0.4±0.11 19.8±1.9 23.3±0.5 4.0±2.7

0.6±0.4 20.0±1.6 23.0±1.5 3.8±2.2

.009 .45 .14 .90