Publications by authors named "George L Zorn"

Unlabelled: A 61-year-old man with end-stage ischemic cardiomyopathy post HeartMate 3 (Abbott laboratories, Chicago, Illinois, USA) left ventricular assist device (LVAD) implant was hospitalized after he had recurrent ventricular tachycardia requiring implantable cardioverter-defibrillator shocks. His transthoracic echocardiogram and computed tomography angiography of the chest showed presence of trace aortic insufficiency (AI) and aortic root thrombus (ART) of non-coronary cusp without obstruction of right or left coronary artery ostium despite therapeutic international normalized ratio. He presented again 3 months later with worsening heart failure signs and symptoms.

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Objective: Patients with elevated CHADS-VASc scores are at high risk for atrial fibrillation (AF) and thromboembolic events (TE) after cardiac surgery. Left atrial appendage exclusion (LAAE) is a permanent, continuous approach to stroke prevention in AF, overcoming limitations of oral anticoagulation (OAC). We report ATLAS trial results focused on LAAE technical success and perioperative safety and TE rates with and without LAAE in cardiac surgery patients who developed postoperative AF (POAF).

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Patients with type B aortic dissection (TBAD) often present as an emergency. Operative repair of TBAD can be indicated for selected patients in the setting of hemodynamic instability or rupture. Thoracic endovascular aortic repair of TBAD has achieved significant popularity.

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Article Synopsis
  • The Evolut Low Risk Trial examined the effectiveness of transcatheter aortic valve replacement (TAVR) in low-risk patients and found it to be comparable to traditional surgical aortic valve replacement (AVR) for reducing all-cause mortality and disabling strokes over two years.
  • The study involved 1,414 patients randomized to either TAVR or surgical AVR, with 730 and 684 attempts at implantation, respectively.
  • Results showed a 2-year primary endpoint event rate of 4.3% for TAVR and 6.3% for surgery, indicating that TAVR is noninferior to surgery, with slightly better outcomes than initially projected in early analyses.
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Background: An increasing body of evidence suggests that packed red blood cell (PRBC) transfusion may be associated with increased morbidity and mortality after transcatheter and surgical aortic valve replacement. It remains unclear whether PRBC transfusion is a surrogate marker or truly an independent risk factor for mortality after aortic valve replacement in different populations.

Methods: The Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial randomized 1660 patients with symptomatic, severe aortic stenosis at intermediate risk for operative death to transcatheter aortic valve replacement or surgical aortic valve replacement.

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Article Synopsis
  • Paravalvular regurgitation (PVR) after transcatheter aortic valve replacement (TAVR) can lead to higher risks of complications and reduced long-term success, prompting the development of the Evolut PRO valve to improve outcomes.
  • A study involving 60 high-risk patients found that after 3 years, significant clinical improvements were observed, with a 25.8% all-cause mortality rate and a 10.7% incidence of disabling strokes, but no repeat valve interventions.
  • The Evolut PRO valve showed excellent hemodynamic performance, with 88.2% of patients experiencing no or only trace PVR and 80.6% reporting minimal symptoms (NYHA class I) three
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Background: Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients.

Methods: We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk. When 850 patients had reached 12-month follow-up, we analyzed data regarding the primary end point, a composite of death or disabling stroke at 24 months, using Bayesian methods.

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Background: The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality-risk patients.

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Objectives: This study sought to evaluate the Medtronic Evolut PRO Transcatheter Aortic Valve System in patients with severe symptomatic aortic stenosis.

Background: A next-generation self-expanding transcatheter aortic valve was designed with an external pericardial wrap with the intent to reduce paravalvular leak while maintaining the benefits of a low-profile, self-expanding, and repositionable supra-annular valve.

Methods: The Medtronic Evolut PRO Clinical Study included 60 patients undergoing transcatheter aortic valve replacement with the Evolut PRO valve at 8 investigational sites in the United States.

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Background: This analysis evaluates the relationship of annular size to hemodynamics and the incidence of prosthesis-patient mismatch (PPM) in surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) patients.

Methods: The CoreValve US Pivotal High Risk Trial, described previously, compared TAVR using a self-expanding valve with SAVR. Multislice computed tomography was used to categorize TAVR and SAVR subjects according to annular perimeter-derived diameter: large (≥26 mm), medium (23 to <26 mm), and small (<23 mm).

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Procedural complications following transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) are usually reported as retrospective analyses. We report the first comparison of complications following SAVR or self-expanding TAVR from a prospectively randomized study of high-risk SAVR patients. Three hundred ninety-five TAVR and 402 SAVR patients were prospectively enrolled and randomized 1:1 to TAVR with a CoreValve bioprosthesis or a surgical bioprosthetic valve.

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Background: Iliofemoral arterial disease can preclude transfemoral (TF) transcatheter aortic valve replacement (TF-TAVR). Transthoracic access by direct aortic or a transapical approach imparts a greater risk of complications and death than TF access. We hypothesized that subclavian/axillary arterial (SCA) access offers equivalent risks and outcomes as TF access.

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Objective: Explore causes and timing of death from the CoreValve US Pivotal High-Risk Trial.

Methods: An independent clinical events committee adjudicated causes of death, followed by post hoc hierarchical classification. Baseline characteristics, early outcomes, and causes of death were evaluated for 3 time periods (selected based on threshold of surgical 30-day mortality and on the differences in the continuous hazard between the 2 groups): early (0-30 days), recovery (31-120 days), and late (121-365 days).

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Importance: Transcatheter aortic valve replacement (TAVR) is now a well-accepted alternative to surgical AVR (SAVR) for patients with symptomatic aortic stenosis at increased operative risk. There is interest in whether TAVR would benefit patients at lower risk.

Objective: The Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) has trended downward in US TAVR trials and the STS/American College of Cardiology Transcatheter Valve Therapy Registry.

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Background: The CoreValve US High-Risk Clinical Study compared clinical outcomes and serial echocardiographic findings in patients with severe aortic valve stenosis after transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis or surgical aortic valve replacement (SAVR).

Methods And Results: Eligible patients were randomly assigned 1:1 to TAVR with a self-expanding bioprosthesis or SAVR (N=747). Echocardiograms were obtained at baseline, discharge, 30 days, 6 months, and 1 year after the procedure and were analyzed at a central core laboratory.

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Background: In patients with severe aortic stenosis at increased risk for surgery, self-expanding transcatheter aortic valve replacement (TAVR) is associated with improved 2-year survival compared with surgery.

Objectives: This study sought to determine whether this clinical benefit was sustained over time.

Methods: Patients with severe aortic stenosis deemed at increased risk for surgery by a multidisciplinary heart team were randomized 1:1 to TAVR or open surgical valve replacement (SAVR).

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Objectives: We compared the incidence of prosthesis-patient mismatch (PPM) between transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis and surgical aortic valve replacement (SAVR) in the CoreValve US High Risk Pivotal Trial. We sought to determine the influence of PPM on clinical outcomes.

Methods: Patients with severe aortic stenosis and at increased risk for surgery were randomized 1:1 to TAVR or SAVR.

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Background: Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) are treatment options for aortic stenosis in patients with prior coronary artery bypass graft surgery. We assessed the major clinical outcomes of such patients enrolled in the CoreValve High Risk (CHR) study.

Methods: Of the 795 CHR study patients, 226 had prior coronary artery bypass graft surgery; 115 underwent TAVR and 111 underwent SAVR.

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Objectives: This study sought to compare the health status outcomes for patients treated with either self-expanding transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (AVR).

Background: In patients at increased surgical risk, TAVR with a self-expanding bioprosthesis is associated with improved 1-year survival compared with AVR. However, elderly patients may be just as concerned with quality-of-life improvement as with prolonged survival as a goal of treatment.

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Background: The U.S. pivotal trial for the self-expanding valve found that among patients with severe aortic stenosis at increased risk for surgery, the 1-year survival rate was 4.

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Objectives: The CoreValve Extreme Risk US Pivotal Trial enrolled patients with symptomatic severe aortic stenosis deemed unsuitable for surgical aortic valve replacement. Implants were attempted using transfemoral access (n = 489) or an alternative access (n = 150). In present analysis, we sought to examine the safety and efficacy of CoreValve transcatheter aortic valve replacement using alternative access.

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Cardiac surgeons are increasingly faced with a more complex patient who has developed a pattern of diffuse coronary artery disease that cannot be completely revascularized by CAGB alone. Considering the increased operative and long-term cardiac risks predicted by incomplete revascularization, and the documented operative and long-term benefits associated with sole therapy and adjunctive TMR in randomized patients with diffuse coronary artery disease, increased use of sole therapy and adjunctive TMR therapy is warranted.

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Background: CD154 mediates key facets of humoral and cellular immunity to alloantigens, and is tolerogenic to influenza antigens in primates. Barriers to CD154-based tolerance induction for primate cardiac allografts have not previously been defined.

Methods: Heterotopic cardiac allograft outcomes in cynomolgus monkeys treated with a CD154 inhibitor, IDEC-131 (n=27), were compared to no treatment (n=4) or cyclosporine A (n=6).

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