Balloon aortic valvuloplasty in high risk aortic stenosis patients with left ventricular ejection fractions <20%.

OBJECTIVES: To determine outcomes following balloon aortic valvuloplasty (BAV) in aortic stenosis (AS) patients with a left ventricular ejection fraction (LVEF) <20%. BACKGROUND: Severe AS patients with a LVEF <20% are excluded from United States (U.S.) transcatheter aortic valve replacement (TAVR) trials and often surgical aortic valve replacement (AVR). The role for BAV to enhance LVEF is unclear. METHODS: Our BAV database of 270 consecutive patients extending from 2005 through 2010 was queried for a preoperative LVEF <20%. Demographics, echocardiograms, procedural technique, and outcomes were analyzed. Pre- and postoperative echocardiograms were used to determine improvement in aortic valve area (AVA) and LVEF. RESULTS: Sixteen patients were identified with a median age of 82 years. The composite Society of Thoracic Surgeons' (STS) mortality risk was 16.4%. The median preoperative AVA and LVEF were 0.60 cm(2) and 16%, respectively, and postoperative AVA and LVEF were 0.77 cm(2) and LVEF 19%, respectively. About 15 of the 16 patients had postoperative echocardiograms available for comparison. And 7 of these 15 (47%) demonstrated improvement in LVEF to ≥20% (median LVEF 25%). The absence of coronary disease and improvement in AVA of ≥0.2 cm(2) was associated with postoperative LVEF of ≥20%. Procedural mortality was 0%. The 30-day, 6-month, and 1-year survival was 69%, 56%, and 29%. STS's mortality risk score ≥15% was associated with short-term mortality. CONCLUSION: With appropriate technique, BAV can be reasonably safe in patients with LVEF <20%. Roughly half of these patients demonstrated improvement in LVEF to ≥20%.

Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study.

OBJECTIVES: The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study (HRS) assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, California) in patients with significant mitral regurgitation (MR) at high risk of surgical mortality rate. BACKGROUND: Patients with severe MR (3 to 4+) at high risk of surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR. METHODS: Patients with severe symptomatic MR and an estimated surgical mortality rate of ≥12% were enrolled. A comparator group of patients screened concurrently but not enrolled were identified retrospectively and consented to compare survival in patients treated by standard care. RESULTS: Seventy-eight patients underwent the MitraClip procedure. Their mean age was 77 years, >50% had previous cardiac surgery, and 46 had functional MR and 32 degenerative MR. MitraClip devices were successfully placed in 96% of patients. Protocol-predicted surgical mortality rate in the HRS and concurrent comparator group was 18.2% and 17.4%, respectively, and Society of Thoracic Surgeons calculator estimated mortality rate was 14.2% and 14.9%, respectively. The 30-day procedure-related mortality rate was 7.7% in the HRS and 8.3% in the comparator group (p = NS). The 12-month survival rate was 76% in the HRS and 55% in the concurrent comparator group (p = 0.047). In surviving patients with matched baseline and 12-month data, 78% had an MR grade of ≤2+. Left ventricular end-diastolic volume improved from 172 ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p = 0.001). New York Heart Association functional class improved from III/IV at baseline in 89% to class I/II in 74% (p < 0.0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 [p = 0.014] and the mental component score from 45.5 to 48.7 [p = 0.065]) at 12 months. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32 (p = 0.034). CONCLUSIONS: The MitraClip device reduced MR in a majority of patients deemed at high risk of surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months. (Pivotal Study of a Percutaneous Mitral Valve Repair System [EVEREST II]; NCT00209274).

iCoapsys mitral valve repair system: Percutaneous implantation in an animal model.

OBJECTIVE: Determine if the iCoapsys device could be accurately and safely implanted using a novel transcatheter system. BACKGROUND: Functional mitral regurgitation is a ventricular disease characterized by mitral insufficiency in the absence of structural valve abnormalities. It occurs in the presence of ischemic or non-ischemic cardiomyopathy. The Coapsys (surgical) transventricular device, currently undergoing randomized evaluation, offers a more integrated treatment strategy. METHODS: The iCoapsys transcatheter mitral valve repair system was developed for percutaneous delivery of an implant designed to emulate the surgical (i.e. Coapsys) device. Nine operators tested the ability of this novel catheter system to successfully deliver and position the iCoapsys implant in 12 adult sheep. RESULTS: Post mortem evaluation in this acute model demonstrated precise percutaneous delivery and implantation in all 12 animals using fluoroscopic, coronary angiographic, and epicardial echo guidance. There was no excessive bleeding, hemodynamic compromise or sustained arrhythmias. CONCLUSIONS: A novel transcatheter methodology was developed to consistently deliver and accurately position the iCoapsys implant. The percutaneous iCoapsys system was successfully implanted without complication in this acute animal model series.

Comparison of outcomes in high-risk patients>70 years of age with aortic valvuloplasty and percutaneous coronary intervention versus aortic valvuloplasty alone.

The goal of this study was to compare outcomes of combined balloon aortic valvuloplasty (BAV) plus percutaneous coronary intervention (PCI) with BAV alone in a surgically high risk, older (>70 years) population with both aortic stenosis (AS) and coronary artery disease (CAD). The medical records, coronary angiograms, and procedural reports of 100 consecutive patients who underwent BAV and coronary angiography at our institution from July 2003 to November 2006 were reviewed. Seventeen patients (mean age 86.2+/-6.4 years) underwent combined (nonstaged) BAV and PCI with a calculated Society of Thoracic Surgery risk score of 13.5%+/-6.7; 13 of these underwent coronary stenting before BAV and 4 after BAV. All 17 patients were successfully treated with this combined strategy. The incidence of periprocedural mortality, myocardial infarction, and stroke was zero. An additional 25 patients (mean age 85.9+/-6.9) with CAD were identified who underwent BAV alone with a Society of Thoracic Surgery risk score of 12.6+/-5.7%. PCI in these patients was avoided primarily because of greater lesion complexity or a perceived low probability of symptomatic benefit. There was 1 procedural death, no myocardial infarction, and 1 postprocedural stroke in these 25 patients. The procedural duration and hospital length of stay for the combined BAV and PCI group was 98.8+/-17.6 minutes and 4.1+/-2.8 days, respectively, and for the BAV only group was 86.2+/-27.3 minutes and 3.3+/-2.1 days, respectively. In conclusion, with appropriate selection, BAV plus PCI was safely performed in this retrospective series of elderly, high-risk patients with severe AS and CAD.

A regional system to provide timely access to percutaneous coronary intervention for ST-elevation myocardial infarction.

BACKGROUND: Percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) is superior to fibrinolysis when performed in a timely manner in high-volume centers. Recent European trials suggest that transfer for PCI also may be superior to fibrinolysis and increase access to PCI. In the United States, transfer times are consistently long; therefore, many believe a transfer for PCI strategy for STEMI is not practical. METHODS AND RESULTS: We developed a standardized PCI-based treatment system for STEMI patients from 30 hospitals up to 210 miles from a PCI center. From March 2003 to November 2006, 1345 consecutive STEMI patients were treated, including 1048 patients transferred from non-PCI hospitals. The median first door-to-balloon time for patients <60 miles (zone 1) and 60 to 210 miles (zone 2) from the PCI center was 95 minutes (25th and 75th percentiles, 82 and 116 minutes) and 120 minutes (25th and 75th percentiles, 100 and 145 minutes), respectively. Despite the high-risk unselected patient population (cardiogenic shock, 12.3%; cardiac arrest, 10.8%; and elderly [> or =80 years of age], 14.6%), in-hospital mortality was 4.2%, and median length of stay was 3 days. CONCLUSIONS: Rapid transfer of STEMI patients from community hospitals up to 210 miles from a PCI center is safe and feasible using a standardized protocol with an integrated transfer system.

Feasibility of transcatheter intervention for severe aortic stenosis in patients >or=90 years of age: aortic valvuloplasty revisited.

OBJECTIVES: The goals of this study were to determine the feasibility, safety, and early outcomes of balloon aortic valvuloplasty (BAV) for severe aortic stenosis in a nonagenarian population. BACKGROUND: This very elderly population is expanding rapidly, has a high incidence of aortic stenosis, and uncommonly undergoes surgical aortic valve replacement. These patients may best be treated with a transcatheter approach due to comorbidities, surgical risk, and personal preference. METHODS: We reviewed 31 consecutive patients >or=90 years of age who underwent BAV at our institution from July 2003 to August 2006 for data pertinent to patient characteristics, procedural techniques, and 30-day outcomes. RESULTS: Our patients had a mean age of 93 +/- 3.0 years (90-101). The society of thoracic surgery risk score was 18.5 (+/-10.2) and logistic Euroscore was 35.8 (+/-19.3). Twenty-five patients (81%) underwent retrograde BAV and 6 (19%) antegrade BAV. Five patients (16%) underwent combined BAV and coronary stenting. Overall mean aortic valve area increased from 0.52 cm2 (+/-0.17) to 0.92 cm2 (+/-0.22) and mean New York Heart Association (NYHA) functional class improved from 3.4 to 1.8. Intraprocedural mortality occurred in one patient (3.2%) and 30-day mortality in three patients (9.7%). CONCLUSIONS: BAV can be carried out in high risk nonagenarian patients with an acceptable complication rate, low perioperative mortality, and early improvement in NYHA functional class.

Radiation following percutaneous balloon aortic valvuloplasty to prevent restenosis (RADAR pilot trial).

OBJECTIVES: We wished to determine the feasibility and early safety of external beam radiation therapy (EBRT) used following balloon aortic valvuloplasty (BAV) to prevent restenosis. BACKGROUND: BAV for calcific aortic stenosis (AS) has been largely abandoned because of high restenosis rates, i.e., > 80% at 1 year. Radiation therapy is useful in preventing restenosis following vascular interventions and treating other benign noncardiovascular disorders. METHODS: We conducted a 20-patient, pilot study evaluating EBRT to prevent restenosis following BAV in elderly patients with calcific AS. Total doses ranging from 12-18 Gy were delivered in fractions over a 3-5 day post-op period to the aortic valve. Echocardiography was performed pre and 2 days post-op, 1, 6, and 12 months following BAV. RESULTS: One-year follow-up is completed (age 89 +/- 4). There were no complications related to EBRT. Eight patients died prior to 1 year; 5 of 10 (50%) in the low-dose (12 Gy) group and 3 of 10 (30%) in the high-dose (15-18 Gy) group. None of these 8 patients had restenosis, i.e., > 50% loss of the initial AVA gain, and only three deaths were cardiac in origin. One patient underwent aortic valve replacement and none repeated BAV. By 1 year, 3 of the initial 10 (30%) in the low-dose group and 1 of 9 (11%) in the high-dose group demonstrated restenosis (21% overall). CONCLUSIONS: EBRT following BAV in elderly patients with AS is feasible, free of early complications, and holds promise in reducing the 1 year restenosis rate in a dose-dependent fashion.