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It is important that the medical profession play a significant role in critically evaluating the use of diagnostic procedures and therapies as they are introduced in the detection, management,

/pdf/acc-aha-2006-guidelines-for-the-management-of-patients-with-27qfh9fc7i.pdf

ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease

Background Many patients with severe aortic stenosis and coexisting conditions are not candi dates for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve implantation (TAVI) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis. Methods We randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve. The primary end point was the rate of death from any cause. Results A total of 358 patients with aortic stenosis who were not considered to be suitable candidates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan–Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P<0.001). The rate of the composite end point of death from any cause or repeat hospitalization was 42.5% with TAVI as com pared with 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35 to 0.59; P<0.001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among patients who had undergone TAVI than among those who had received standard therapy (25.2% vs. 58.0%, P<0.001). At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs. 1.1%, P = 0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001). In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram. Conclusions In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.)

/pdf/transcatheter-aortic-valve-implantation-for-aortic-stenosis-54sqmga4d1.pdf

Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery

A b s t r ac t Background The use of transcatheter aortic-valve replacement has been shown to reduce mortality among high-risk patients with aortic stenosis who are not candidates for surgical replacement. However, the two procedures have not been compared in a randomized trial involving high-risk patients who are still candidates for surgical replacement. Methods At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either transcatheter aortic-valve replacement with a balloon-expandable bovine pericardial valve (either a transfemoral or a transapical approach) or surgical replacement. The primary end point was death from any cause at 1 year. The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement. Results The rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P = 0.07) and 24.2% and 26.8%, respectively, at 1 year (P = 0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; P = 0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P = 0.20) and 5.1% and 2.4%, respectively, at 1 year (P = 0.07). At 30 days, major vascular compli- cations were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, P<0.001); adverse events that were more frequent after surgical replacement included major bleeding (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%, P = 0.006). More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days, but by 1 year, there was not a significant between-group difference. Conclusions In high-risk patients with severe aortic stenosis, transcatheter and surgical proce- dures for aortic-valve replacement were associated with similar rates of survival at 1 year, although there were important differences in periprocedural risks. (Funded by Edwards Lifesciences; Clinical Trials.gov number, NCT00530894.)

/pdf/transcatheter-versus-surgical-aortic-valve-replacement-in-1g5w8nl0h8.pdf

Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients

https://www.medpagetoday.com/upload/2014/3/3/02536-1.pdf

2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease

2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines

From 1962-1977, 99 patients, mean age 65 +/- 0.5 years (range 60-81 years) underwent valve replacement for severe calcific aortic valve stenosis. Ninety-three percent of the patients were in New York Heart Association functional class III or IV. The aortic valve gradient was 76 +/- 3 mm Hg and the aortic valve area index was 0.34 +/- 0.01 cm2/m2. Left ventricular systolic pressure was 207 +/- 4 mm Hg, cardiac index was 2.5 +/- 0.1 l/min/m2, left ventricular ejection fraction was 0.57 +/- 0.02 and left ventricular end-diastolic volume index was 108 +/- 60 ml/m2; left ventricular ejection fraction and end-diastolic volume were normal in 63% of the patients. The operative mortality was 16%. Mean follow-up is 55 +/- 4 months. Using life-table analysis, the 10-year survival, excluding cardiac deaths, is 57.5 +/- 7%. Ninety-one percent of the survivors are in functional class I or II. We conclude that the left ventricular function is normal in two-thirds of elderly patients with severe aortic valve stenosis. After valve replacement, the 10-year survival is most encouraging and most of the survivors are functionally improved.

Severe aortic stenosis in patients 60 years of age or older: left ventricular function and 10-year survival after valve replacement.

We studied the effects of afterload reduction in chronic severe aortic insufficiency by measuring the hemodynamic response to oral hydralazine in 10 consecutive patients. Hemodynamics were also measured during maximal exercise in eight of these patients. At rest, hydralazine reduced pulmonary artery wedge pressure from 14 to 9 mm Hg (p less than 0.01), and increased cardiac index by 70% and stroke volume index by 35% (both p less than 0.001). Before hydralazine, pulmonary artery wedge pressure exceeded 20 mm Hg in five patients during maximal exercise; with hydralazine, at identical levels of exercise, pulmonary artery wedge pressure remained below 20 mm Hg in all patients. For the group, hydralazine reduced pulmonary artery wedge pressure from 21 to 12 mm Hg (p less than 0.05) and increased cardiac index by 31% (p less than 0.05) during exercise; changes in stroke volume index were more variable and there was no significant increase for the group, although several patients increased stroke volume substantially and the overall increase was 34%. These data show that afterload reduction has beneficial effects on cardiac performance in chronic severe aortic insufficiency both at rest and during exercise. Hydralazine may be of use in such patients either in preparation for valve replacement or as interim therapy.

Beneficial effects of hydralazine on rest and exercise hemodynamics in patients with chronic severe aortic insufficiency.

We prospectively followed 257 patients with bifascicular and trifascicular conduction-system disease and intact atrioventricular conduction who had undergone His-bundle studies. Forty-seven per cent had associated coronary-artery disease, and 23 per cent primary conduction-system disease. His-ventricular interval was moderately prolonged in 43 per cent and markedly prolonged in 12 per cent. During an average follow-up period of 25 months 50 patients died. However, death was sudden in only 27, and 17 of the sudden deaths were not due to bradyarrhythias. Actuarial analysis showed an overall mortality rate (mean +/- S.E.) of 19 +/- 2.6 per cent at two years, mortality from sudden death being 10 +/- 2.6 per cent. Permanent heart block occurred in 12. No clinical symptoms (including syncope), electrocardiographic findings, electrophysiologic data or their combination identified patients at high risk of sudden death. Sudden death due to bradyarrhythmia is uncommon in patients with bundle-branch block and intact atrioventricular conduction. Therefore, routine prophylactic use of permanent pacemakers in all such patients is inappropriate. Pacemaker implantation should be reserved for those with documented symptomatic bradyarrhythmias.

A Prospective Study of Sudden Death in High-Risk Bundle-Branch Block

To determine how arteriolar dilation improves cardiac performance in aortic insufficiency, we evaluated the acute effects of hydralazine in 10 patients with chronic severe aortic insufficiency. Control measurements of intracardiac and intravascular pressures, cardiac output and left ventricular volumes were obtained at cardiac catheterization. Hydralazine, 0.3 mg/kg i.v. (maximal dose 20 mg), was administered and all measurements were repeated 30 minutes later. A reduction in systemic vascular resistance from 1264 to 710 dyn-sec-cm-5 was associated with significant increases in forward cardiac index (2.9 to 5.1 l/min/m2) and stroke volume index (37 to 55 ml/m2). Left ventricular end-diastolic pressure was reduced from 19 to 12 mm Hg. There was a significant reduction in mean arterial pressure (88 to 83 mm Hg) and a significant increase in heart rate (81 to 94 beats/min). Regurgitant stroke volume was reduced by more than 10 ml/m2 in seven patients and for the group was significantly reduced, from 65 to 53 ml/m2. Regurgitant fraction was reduced in all patients; the overall reduction from 0.64 to 0.48 was highly significant. Ejection fraction increased more than 0.10 in four patients, by 0.08 in an additional patient and for the group increased significantly from 0.50 to 0.57. Left ventricular end-diastolic volume decreased by more than 25 ml/m2 in four patients, by 19 ml/m2 in an additional patient and was decreased significantly, from 208 to 190 ml/m2, for the group. Arteriolar dilators improve cardiac performance in aortic insufficiency by reducing the amount of aortic regurgitation and, in some patients, by substantially improving systolic pump fraction. These data suggest a role for arteriolar dilators in the management of selected patients with aortic insufficiency.

Mechanism for improved cardiac performance with arteriolar dilators in aortic insufficiency.

We studied 16 patients with severe mitral regurgitation to determine the acute effects of hydralazine on cardiac performance at rest and during exercise and to assess the long-term clinical response to therapy. At rest, optimal-dose hydralazine (range 50-225 mg) reduced systemic vascular resistance from 1385 ± 88 to 964 ± 76 dyn-sec-cm-5 (mean ± SEM) (p < 0.001). As a result, pulmonary artery wedge pressure decreased from 18 ± 2 to 15 ± 2 mm Hg (p < 0.025), cardiac index increased from 2.5 ± 0.1 to 3.7 ± 0.2 I/min/m2 (p < 0.001) and stroke volume index increased from 30 ± 2 to 39 ± 2 mI/m' (p < 0.001). The effects of hydralazine on exercise hemodynamics were evaluated in 12 patients. Before treatment, the patients exercised at increasing work loads until limited by symptoms. After hydralazine therapy, exercise was repeated at identical work loads. Although exercise alone resulted in a reduction in systemic vascular resistance, from 1385 ± 88 to 1111 ± 118 dyn-sec-cm-, the addition of hydralazine caused a further reduction in resistance, from 1111 ± 118 to 755 ± 72 dyn-sec-cm' (p < 0.005). Hydralazine reduced pulmonary artery wedge pressure during exercise from 27 ± 2 to 21 ± 1 mm Hg and increased cardiac index from 3.7 ± 0.3 to 4.9 ± 0.3 1/min/m2 (bothp < 0.001) and stroke volume index from 36 ± 3 to 45 ± 2 ml/in (p < 0.005). All 16 patients were discharged on hydralazine therapy and their clinical course was followed. A marked improvement in symptoms from New York Heart Association functional class III-VI to class I-II, which was sustained for at least 6 months, occurred in seven patients (44%). One patient improved from class IV to class III. The mean follow-up in these eight patients has been 13 ± 4 months. In four of the eight remaining patients, hydralazine was discontinued because of intolerable side effects. Mitral valve surgery was performed in three of these patients as well as in four patients who demonstrated an initial hemodynamic response to therapy but failed to experience symptomatic improvement. These data demonstrate that hydralazine therapy results in substantial improvement in cardiac performance in patients with mitral regurgitation. The beneficial effects seen at rest are maintained during exercise. The acute improvement in hemodynamics resulted in sustained clinical improvement in half the patients with mitral regurgitation; the other half needed valve surgery. Arterial dilator therapy is of benefit for some patients with severe mitral regurgitation.

Edward S. Murphy

Papers

Severe aortic stenosis in patients 60 years of age or older: left ventricular function and 10-year survival after valve replacement.

Beneficial effects of hydralazine on rest and exercise hemodynamics in patients with chronic severe aortic insufficiency.

A Prospective Study of Sudden Death in High-Risk Bundle-Branch Block

Mechanism for improved cardiac performance with arteriolar dilators in aortic insufficiency.

Arterial dilators in mitral regurgitation: effects on rest and exercise hemodynamics and long-term clinical follow-up.