ABSTRACT: A ground-breaking, US Food and Drug Administration clinical trial for the treatment of critical aortic stenosis commenced at our institution in November 2007 with our first transcatheter aortic valve repair (TAVR). This novel procedure created a new treatment option for high-risk patients with aortic stenosis. Although the pivotal trial completed enrollment in 2009, continued access was implemented by the Food and Drug Administration in response to an unprecedented demand for this new procedure by patients and physicians. This is an overview of one site's management strategy for patient referrals.
Patients underwent evaluation with a comprehensive assessment in a multidisciplinary transcatheter aortic valve clinic. All screened patients were classified as either traditional open surgical candidates or nonsurgical candidates. Major exclusions for open procedures included low Society of Thoracic Surgeons score, coronary artery disease, and other valvular disease. Major exclusions of nonsurgical candidates resulted from physician discretion or multiple comorbidities such as renal failure, significant liver or lung disease, and progressive cancer. A third group of patients was excluded because of inadequate femoral access.
From November 2007 to November 2010, 681 patients were referred for evaluation, including 578 screened patients and 103 patients whose evaluation was pending. During the screening process, 82 patients died (12%). Among 343 patients who did not qualify for enrollment (50%), 108 received open surgical intervention and 235 were nonsurgical candidates; 35 of these patients underwent balloon aortic valvuloplasty. A total of 153 patients were enrolled in the TAVR trial.
With the availability of a novel treatment option for aortic stenosis in high-risk patients, institutions offering these alternative methods will be forced to reevaluate patient management. A careful strategy that includes multidisciplinary evaluation is crucial in order to have a successful transcatheter aortic valve program.
The Annals of thoracic surgery 12/2011; 92(6):2072-6; discussion 2076-7. · 3.74 Impact Factor
ABSTRACT: There have been major advances in the management of aortic valve disease. Because bicuspid aortic valve is common and predicts an increased risk of adverse aortic events, these patients merit aortic surveillance and consideration for ascending aortic replacement when its diameter exceeds 4.0 cm. Serial quantitative echocardiographic analysis, as compared with traditional clinical markers, can result in better timing of surgical intervention for aortic regurgitation. Furthermore, echocardiographic analysis of aortic regurgitation can classify the mechanism based on cusp mobility to guide aortic valve repair. In aortic root replacement, aortic valve preservation with reimplantation is a mainstream surgical option in Marfan syndrome to offer freedom from valve-related anticoagulation. Prosthetic aortic root replacement has further alternatives with the introduction of the aortic neosinus design and acceptable clinical outcomes with the porcine xenograft. Because aortic valve prosthesis-patient mismatch (PPM) may adversely affect patient outcome, its perioperative prevention is important. Furthermore, significant functional mitral regurgitation in association with aortic stenosis often resolves after aortic valve replacement. Echocardiographic assessment of the aortic valve must include valve area because the transaortic pressure gradient may be low in severe stenosis. Aortic valve replacement with partial sternotomy is safe and offers a reasonable less invasive alternative. Transcatheter aortic valve replacement, whether transfemoral or transapical, has revolutionized aortic valve replacement; it remains a major theme in the specialty for 2009 and beyond.
Journal of cardiothoracic and vascular anesthesia 07/2009; 23(4):569-76. · 1.06 Impact Factor
ABSTRACT: Acute type A aortic dissection is a surgical emergency, with an operative mortality as high as 25%. Ischemia is a known predictor of mortality. We tested the efficacy of a classification system--the Penn classification, which is based on ischemic pattern at clinical presentation--to stratify operative mortality risk and identify high-risk groups of patients for further intervention and study.
In this prospective observational study, patients underwent a standard aortic dissection repair protocol at the University of Pennsylvania, Philadelphia, PA, from 1993 to 2004. Patients were classified as having no ischemia, branch vessel malperfusion with localized organ ischemia, generalized ischemia with circulatory collapse, with or without cardiac involvement, or a combination of localized and generalized ischemia.
The cohort comprised 221 patients. The mean age was 61.6 (+/- 14.8) years and 66.5% were male. At presentation 57.9% of patients had no ischemia, 17.6% had localized ischemia, 15.4% had generalized ischemia, and 9.0% had both localized and generalized ischemia. Overall, 28 (12.7%) patients died during the perioperative period. All-cause mortality differed significantly between groups (no ischemia 3.1%, localized ischemia 25.6%, generalized ischemia 17.6%, combined ischemia 40.0%), yielding an overall 8.3-fold difference for no compared with any ischemia (3.1% versus 25.8%, P = 0.0001). Ischemic presentations together accounted for 85.7% of all deaths.
The Penn classification of acute type A aortic dissection enabled stratification of patients by operative mortality risk. The system requires further validation, but might facilitate new ways to analyze mortality data for this disorder.
Nature Clinical Practice Cardiovascular Medicine 01/2009; 6(2):140-6. · 7.04 Impact Factor