Health status after transcatheter aortic valve replacement in patients at extreme surgical risk: results from the CoreValve U.S. trial.

OBJECTIVES: The purpose of this study was to characterize health status outcomes after transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis among patients at extreme surgical risk and to identify pre-procedural patient characteristics associated with a poor outcome. BACKGROUND: For many patients considering TAVR, improvement in quality of life may be of even greater importance than prolonged survival. METHODS: Patients with severe, symptomatic aortic stenosis who were considered to be at prohibitive risk for surgical aortic valve replacement were enrolled in the single-arm CoreValve U.S. Extreme Risk Study. Health status was assessed at baseline and at 1, 6, and 12 months after TAVR using the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Short Form-12, and the EuroQol-5D. The overall summary scale of the KCCQ (range 0 to 100; higher scores = better health) was the primary health status outcome. A poor outcome after TAVR was defined as death, a KCCQ overall summary score (OS) <45, or a decline in KCCQ-OS of 10 points at 6-month follow-up. RESULTS: A total of 471 patients underwent TAVR via the transfemoral approach, of whom 436 (93%) completed the baseline health status survey. All health status measures demonstrated considerable impairment at baseline. After TAVR, there was substantial improvement in both disease-specific and generic health status measures, with an increase in the KCCQ-OS of 23.9 points (95% confidence interval [CI]: 20.3 to 27.5 points) at 1 month, 27.4 points (95% CI: 24.2 to 30.6 points) at 6 months, 27.4 points (95% CI: 24.1 to 30.8 points) at 12 months, along with substantial increases in Short Form-12 scores and EuroQol-5D utilities (all p < 0.003 compared with baseline). Nonetheless, 39% of patients had a poor outcome after TAVR. Baseline factors independently associated with poor outcome included wheelchair dependency, lower mean aortic valve gradient, prior coronary artery bypass grafting, oxygen dependency, very high predicted mortality with surgical aortic valve replacement, and low serum albumin. CONCLUSIONS: Among patients with severe aortic stenosis, TAVR with a self-expanding bioprosthesis resulted in substantial improvements in both disease-specific and generic health-related quality of life, but there remained a large minority of patients who died or had very poor quality of life despite TAVR. Predictive models based on a combination of clinical factors as well as disability and frailty may provide insight into the optimal patient population for whom TAVR is beneficial. (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).

Mitral valve operations through standard and smaller incisions.

OBJECTIVE: Evaluate the operative results of mitral valve repair (MVV) and mitral valve replacement (MVR) performed through standard and smaller incisions. METHODS: From January 1997 through December 2002, 821 consecutive patients underwent mitral valve operation. Of these procedures, 475 were MVV and 346 were MVR. A logistic regression model was developed to identify the risk factors for early mortality and to evaluate the effect of replacement versus repair and standard versus small incision. RESULTS: Replacement patients were older, more likely New York Heart Association (NYHA) class III or IV, more likely female, and had more frequent previous median sternotomy and stroke (all P <.05). The mitral diagnoses in the 2 groups were markedly different. Prolapse and ischemia dominated the repairs, whereas calcific and rheumatic diagnoses required replacement. There were 667 concomitant procedures performed on these patients, most commonly coronary artery bypass graft (229), aortic valve replacement (170), maze (79), and tricuspid valve (TV) repair/replacement (73). Thirty-three patients (4.0%) died in the postoperative period, 2.3% after repair and 6.4% after replacement ( P <.01). Endocarditis (4/17), calcific disease (7/73), and ischemic disease (9/121) accounted for 26% of patients and 60% of deaths. Multivariate regression analysis identified NYHA class, emergent status, concomitant TV operation, and history of renal failure, but not repair versus replacement, as independent risk factors predicting mortality. We estimated that 356 of the 821 patients (43%) were candidates for small-incision operations, the others were excluded by the need for concomitant procedure or other cause. A total of 205/356 (57%) actually underwent small-incision operations, all with central cannulation and standard techniques. From 1997-1999, 32% of eligible patients were so treated, but from 2000-2002, with increasing surgeon experience, this percentage rose significantly to 71% ( P <.01). Eligible patients who underwent small-incision operation were younger and had lower NYHA classifications, lower preoperative creatinine, and shorter length of stay (all P <.01) than those who had standard incisions. Cross-clamp time, perfusion time, and mortality rate were not significantly different. CONCLUSIONS: The mortality rate for MV operations is concentrated among a few diagnoses. In some patients surgery may be approached safely through smaller incisions without introducing new elements of operative risk.

The risks and benefits of reoperative aortic valve replacement.

BACKGROUND: Many patients are advised to have mechanical aortic valve replacement (AVR) because their expected longevity exceeds that of tissue prostheses. This strategy may avoid the risks of reoperation but exposes patients to the risks of long-term anticoagulation therapy. Which risk is greater? METHODS: We reviewed the records of 1213 consecutive, unselected AVR patients, 60% of whom had concomitant procedures, who were treated from 1994 through 2002. Of these patients, 887 were first-time AVR patients, and 326 underwent reoperation. Of the reoperation patients, 134 had previously undergone AVR (redo). We constructed a risk model from these 1213 cases to assess the factors that predicted mortality and to examine the extent to which reoperation affected outcome. RESULTS: Multiple logistic regression analysis indicated that factors of reoperation and redo operation did not predict mortality. In fact, the mortality rate was 4.1% for all first AVR operations and 3.1% for all reoperation AVR ( P =.891). Significant predicting factors (with odds ratios) were reoperative dialysis (6.03), preoperative shock (3.68), New York Heart Association class IV (2.20), female sex (1.76), age (1.61), and cardiopulmonary bypass time (1.26). CONCLUSIONS: In this series, the risk of reoperation AVR is comparable with the published risks of long-term warfarin sodium (Coumadin) administration after mechanical AVR. Any adult who requires AVR may be well advised to consider tissue prostheses.

Biventricular pacing during cardiac operations.

BACKGROUND: Biventricular pacing (resynchronization therapy) improves the duration and quality of life in a subset of patients with congestive heart failure, but this technique has received little attention in the cardiac surgery literature. This report presents some preliminary ideas about its rationale and technique, and some likely indications for this procedure during the performance of cardiac operations. METHODS: We briefly summarize the theory and the results of the randomized clinical trials of resynchronization therapy that led us to consider biventricular pacing for high-risk cardiac surgery patients. We present s ome techniques for using temporary and permanent biventricular pacing in the operating room. We review the hospital records and present early results of the first 25 patients in whom we implanted permanent left ventricular free wall pacing electrodes with the intent of implanting biventricular pacing devices. CONCLUSIONS: Biventricular pacing has great potential to simplify the management and improve the outcomes of some cardiac surgical patients.

Routine enlargement of the small aortic root: a preventive strategy to minimize mismatch.

BACKGROUND: We routinely use aortic root enlargement (ARE) as part of one strategy to avoid prosthesis-patient mismatch in patients with relatively small aortic roots who are undergoing aortic valve replacement (AVR). METHODS: We performed a retrospective review of 657 consecutive stented AVR patients at a single institution between 1995 to 2001. Of these, 114 (17%) patients underwent ARE. Root enlargement was selectively performed in patients at risk for prosthesis-patient mismatch, defined as calculated projected indexed effective orifice area (iEOA) less than 0.85 cm2/m2. This involved extension of the aortotomy between the left and noncoronary cusps, valve implantation, and Dacron patch closure of the aorta, thus permitting replacement with a valve size appropriate to body surface area. RESULTS: The mean age of ARE patients was 72.5 +/- 11.0 years, with 32% aged 80 years or more. Of the patients, 61% were female and 27% had undergone previous cardiac operations. Combined procedures included coronary bypass in 57 patients and mitral repair or replacement in 24. The prevalence of mismatch was less than 3%. The ARE required an average of 19 minutes of additional aortic clamp time. The 30-day mortality was 0.9%. Logistic regression showed perfusion time to be the only independent predictor of mortality. CONCLUSIONS: Our results show that ARE can be performed readily and with minimal added risk relative to standard AVR. We also present a preventive strategy to minimize mismatch predicted at time of operation from the reference value of effective orifice area for a given prosthesis and the patient's size. This includes use of ARE to enhance the potential benefit of AVR.