G. Michael Deeb

Transcatheter aortic-valve replacement with a self-expanding prosthesis.

BACKGROUND We compared transcatheter aortic-valve replacement (TAVR), using a self-expanding transcatheter aortic-valve bioprosthesis, with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery. METHODS We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center. Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors. Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (TAVR group) or to surgical aortic-valve replacement (surgical group). The primary end point was the rate of death from any cause at 1 year, evaluated with the use of both noninferiority and superiority testing. RESULTS A total of 795 patients underwent randomization at 45 centers in the United States. In the as-treated analysis, the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group (14.2% vs. 19.1%), with an absolute reduction in risk of 4.9 percentage points (upper boundary of the 95% confidence interval, -0.4; P<0.001 for noninferiority; P = 0.04 for superiority). The results were similar in the intention-to-treat analysis. In a hierarchical testing procedure, TAVR was noninferior with respect to echocardiographic indexes of valve stenosis, functional status, and quality of life. Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke. CONCLUSIONS In patients with severe aortic stenosis who are at increased surgical risk, TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement. (Funded by Medtronic; U.S. CoreValve High Risk Study ClinicalTrials.gov number, NCT01240902.).

Intermediate-Term Outcome Of Mitral Reconstruction In Cardiomyopathy

OBJECTIVE Severe mitral regurgitation is a frequent complication of end-stage cardiomyopathy that contributes to heart failure and predicts a poor survival. We studied the intermediate-term outcome of mitral reconstruction in 48 patients who had cardiomyopathy with severe mitral regurgitation and were operated on between June 1993 and June 1997. METHODS Ages ranged from 33 to 79 years (63 +/- 6 years) with left ventricular ejection fractions of 8% to 25% (16% +/- 3%). All patients were receiving maximal drug therapy and were in New York Heart Association class III-IV with severe, refractory 4+ mitral regurgitation. Operatively, all 48 had undersized flexible annuloplasty rings inserted, 7 had coronary bypass grafts for incidental disease, 11 had prior bypass grafts, and 11 also had tricuspid valve repair. RESULTS One operative death occurred as a result of right ventricular failure. Postoperative transesophageal echocardiography revealed mild mitral regurgitation in 7 patients and no mitral regurgitation in 41. There were 10 late deaths, 2 to 47 months after mitral reconstruction. The 1- and 2-year actuarial survivals have been 82% and 71%. At a mean follow-up of 22 months, the number of hospitalizations for heart failure has decreased, and 1 patient has had heart transplantation. Significantly, New York Heart Association class improved from 3.9 +/- 0.3 before the operation to 2.0 +/- 0.6 after the operation. Twenty-four months after the operation, left ventricular volume and sphericity have decreased, whereas ejection fraction and cardiac output have increased. CONCLUSION Whether this favorable modification of left ventricular function and geometry will persist remains unknown. However, mitral repair for cardiomyopathy with mitral regurgitation allows new strategies for these patients.

Preoperative Amiodarone as Prophylaxis against Atrial Fibrillation after Heart Surgery

Background Atrial fibrillation occurs commonly after open-heart surgery and may delay hospital discharge. The purpose of this study was to assess the use of preoperative amiodarone as prophylaxis against atrial fibrillation after cardiac surgery. Methods In this double-blind, randomized study, 124 patients were given either oral amiodarone (64 patients) or placebo (60 patients) for a minimum of seven days before elective cardiac surgery. Therapy consisted of 600 mg of amiodarone per day for seven days, then 200 mg per day until the day of discharge from the hospital. The mean (±SD) preoperative total dose of amiodarone was 4.8±0.96 g over a period of 13 ± 7 days. Results Postoperative atrial fibrillation occurred in 16 of the 64 patients in the amiodarone group (25 percent) and 32 of the 60 patients in the placebo group (53 percent) (P = 0.003). Patients in the amiodarone group were hospitalized for significantly fewer days than were patients in the placebo group (6.5 ± 2.6 vs. 7.9 ± 4.3 days, P = 0.04). ...

Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery

OBJECTIVES This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery. BACKGROUND Untreated severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy. METHODS We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG). RESULTS A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis). CONCLUSIONS TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients

Background Although transcatheter aortic‐valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk. Methods We evaluated the clinical outcomes in intermediate‐risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self‐expanding prosthesis) with surgical aortic‐valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic‐valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement. Results A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (±SD) age of the patients was 79.8±6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5±1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, ‐5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic‐valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group. Conclusions TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910.)

Early outcome of mitral valve reconstruction in patients with end-stage cardiomyopathy

Uncontrollable severe mitral regurgitation is a frequent complication of end-stage cardiomyopathy, significantly contributing to heart failure in these patients, and predicts a poor survival. Although elimination of mitral valve regurgitation could be most beneficial in this group, corrective mitral valve surgery has not been routinely undertaken in these very ill patients because of the presumed prohibitive operative mortality. We studied the early outcome of mitral valve reconstruction in 16 consecutive patients with cardiomyopathy and severe, refractory mitral regurgitation operated on between June 1993 and April 1994. There were 11 men and five women, aged 44 to 78 years (64 +/- 8 years) with left ventricular ejection fractions of 9% to 25% (16% +/- 5%). Preoperatively all patients were in New York Heart Association class IV, had severe mitral regurgitation (graded 0 to 4+ according to color flow Doppler transesophageal echocardiography) and two were listed for transplantation. Operatively, a flexible annuloplasty ring was implanted in all patients. Four patients also had single coronary bypass grafting for incidental coronary disease. In four patients the operation was performed through a right thoracotomy because of prior coronary bypass grafting, and four patients also underwent tricuspid valve reconstruction for severe tricuspid regurgitation. No patient required support with an intraaortic balloon pump. There were no operative or hospital deaths and mean hospital stay was 10 days. There were three late deaths at 2, 6, and 7 months after mitral valve reconstruction, and the 1-year actuarial survival has been 75%. At a mean follow-up of 8 months, all remaining patients are in New York Heart Association class I or II, with a mean postoperative ejection fraction of 25% +/- 10%. There have been no hospitalizations for congestive heart failure, and a decrease in medications required has been noted. For patients with cardiomyopathy and severe mitral regurgitation, mitral valve reconstruction as opposed to replacement can be accomplished with low operative and early mortality. Although longer term follow-up is mandatory, mitral valve reconstruction may allow new strategies for patients with end-stage cardiomyopathy and severe mitral regurgitation, yielding improvement in symptomatic status and survival.

The dissected aorta: Percutaneous treatment of ischemic complications - Principles and results

PURPOSE Describe the principles and results of percutaneous treatment of ischemic complications of aortic dissection. MATERIALS AND METHODS Twenty-four patients with aortic dissection complicated by ischemic compromise of the liver or bowel (n = 15), kidney (n = 18), or lower extremity (n = 13) were evaluated by means of aortography, intravascular ultrasound, and manometry, and were treated percutaneously. Visceral arteries were classified as obstructed or nonobstructed. Obstruction was classified as static, in which the dissecting hematoma extended into and narrowed the lumen of a branch artery, or dynamic, in which the dissection flap prolapsed into the vessel origin or narrowed the true lumen (TL) above it. Treatment consisted of vascular stents alone (n = 4), or balloon fenestration (n = 20) without (n = 8) or with (n = 12) vascular stents. RESULTS Obstruction was present in 77 arteries and was static in 12 arteries, dynamic in 45 arteries, static and dynamic in 17 arteries, and indeterminate in three arteries. Percutaneous treatment did not alter false lumen (FL) pressure, but reduced the peak systolic interluminal pressure gradient from 28 mm Hg to 2 mm Hg and restored flow in 71 of 77 arteries (92%). Six patients died within 30 days (25% operative mortality), none as a result of the procedure. Two additional patients died in follow-up from complications of an expanding FL. Technical complications in two patients due to altered hemodynamics after initial intervention were recognized and corrected percutaneously during the same procedure. CONCLUSIONS Percutaneous fenestration and endovascular stent deployment are indicated to restore blood flow to arteries compromised by aortic dissection. The prognosis of patients is related to the ischemic injury sustained prior to the percutaneous interventional procedure and, in patients with acute type I dissection who have not undergone surgery, to the preoperative stability of the FL.

Iatrogenic aortic dissection

Given the difference in risk factors, clinical presentation, and outcomes, clinicians should be vigilant for the presence of iatrogenic AD, particularly in those patients with unexplained hemodynamic instability or myocardial ischemia following invasive vascular procedures or CABG.

Accuracy of intraoperative transesophageal echocardiography for estimating the severity of functional mitral regurgitation

Although intraoperative transesophageal echocardiography (TEE) is used to guide mitral valve reconstructive procedures, the effects of hemodynamic alterations accompanying general anesthesia on mitral regurgitation (MR) are unknown. This study was performed to evaluate the effect of general anesthesia on MR jet size using TEE with color Doppler imaging in patients undergoing mitral valve surgery. Matched preoperative TEEs performed with the patient under intravenous conscious sedation, and intraoperative studies performed with the patient under general anesthesia were retrospectively reviewed in 46 patients undergoing mitral valve surgery. Patients were divided into groups based on etiology of MR, including 21 patients with myxomatous degeneration and leaflet flail, 19 patients with structurally normal leaflets and functional regurgitation due to abnormal leaflet coaptation, and 6 patients with rheumatic mitral disease. On both preoperative and intraoperative studies, regurgitation was quantified using maximal jet area and jet diameter at the vena contracta on color flow Doppler. Patients with leaflet flail and patients with functional MR had similar measures of regurgitation severity on preoperative imaging. On intraoperative imaging, regurgitant jet size was unchanged compared with preoperative studies among patients with leaflet flail (jet diameter 1.04 +/- 0.26 vs 1.10 +/- 0.28 cm, area 9.8 +/- 4.5 vs 10.1 +/- 5.2 cm2 on preoperative studies), although jet size decreased significantly in patients with functional MR (jet diameter 0.79 +/- 0.33 vs 1.10 +/- 0.29 cm [p < 0.001], area 5.7 +/- 3.5 vs 10.0 +/- 3.8 cm2 [p < 0.001] on preoperative studies). These findings were not accounted for by variation in heart rate, blood pressures, echocardiographic instrumentation, or Doppler Nyquist limit.(ABSTRACT TRUNCATED AT 250 WORDS)

Operative delay for peripheral malperfusion syndrome in acute type A aortic dissection: a long-term analysis.

BACKGROUND We previously reported an improvement in early mortality for patients presenting with acute type A dissection with malperfusion using a strategy of initial percutaneous intervention to restore end-organ perfusion and delayed operative repair after resolution of the malperfusion syndrome. This study evaluates the late outcomes with this approach. METHODS A total of 196 patients were admitted with acute type A dissection (1997-2007). Seventy patients with ischemic end-organ dysfunction underwent percutaneous fenestration or branch vessel stenting. Operative therapy was planned after resolution of the reperfusion injury. Outcomes were compared for patients with (MP) and without (UC) dissection with ischemic end-organ dysfunction. RESULTS The mean age of the patients was 57.1 years, and 173 patients underwent operative repair (n = 126 UC group; n = 47 MP group). The remaining 23 patients in the MP group died before repair from complications of malperfusion (11) or aortic rupture (12) while awaiting resolution of the malperfusion syndrome. Operative mortality was seen in 9.2% of all patients (9.5% in UC group vs 8.5% in MP group; P = 1.0). On analysis of the entire cohort (n = 196), the mean survival was higher for the uncomplicated group (95.9 months for UC group vs 53.7 months for MP group; P < .001). A subgroup analysis of patients who underwent operation (n = 173) revealed similar mean survival (95.9 months for UC group vs 80.5 months for MP group; P = .45). CONCLUSION A strategy of immediate reperfusion, stabilization, and planned operative repair for acute type A dissection with malperfusion still carries a significant risk for early and late mortality. However, those patients who survive the initial malperfusion and undergo repair have a similar operative and late survival when compared with those patients presenting with uncomplicated dissection.