Transcatheter aortic-valve replacement for inoperable severe aortic stenosis.

BACKGROUND: Transcatheter aortic-valve replacement (TAVR) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The outcomes beyond 1 year in such patients are not known. METHODS: We randomly assigned patients to transfemoral TAVR or to standard therapy (which often included balloon aortic valvuloplasty). Data on 2-year outcomes were analyzed. RESULTS: A total of 358 patients underwent randomization at 21 centers. The rates of death at 2 years were 43.3% in the TAVR group and 68.0% in the standard-therapy group (P<0.001), and the corresponding rates of cardiac death were 31.0% and 62.4% (P<0.001). The survival advantage associated with TAVR that was seen at 1 year remained significant among patients who survived beyond the first year (hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.92; P=0.02 with the use of the log-rank test). The rate of stroke was higher after TAVR than with standard therapy (13.8% vs. 5.5%, P=0.01), owing, in the first 30 days, to the occurrence of more ischemic events in the TAVR group (6.7% vs. 1.7%, P=0.02) and, beyond 30 days, to the occurrence of more hemorrhagic strokes in the TAVR group (2.2% vs. 0.6%, P=0.16). At 2 years, the rate of rehospitalization was 35.0% in the TAVR group and 72.5% in the standard-therapy group (P<0.001). TAVR, as compared with standard therapy, was also associated with improved functional status (P<0.001). The data suggest that the mortality benefit after TAVR may be limited to patients who do not have extensive coexisting conditions. Echocardiographic analysis showed a sustained increase in aortic-valve area and a decrease in aortic-valve gradient, with no worsening of paravalvular aortic regurgitation. CONCLUSIONS: Among appropriately selected patients with severe aortic stenosis who were not suitable candidates for surgery, TAVR reduced the rates of death and hospitalization, with a decrease in symptoms and an improvement in valve hemodynamics that were sustained at 2 years of follow-up. The presence of extensive coexisting conditions may attenuate the survival benefit of TAVR. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).

Randomized trial of surgical cutdown versus percutaneous access in transfemoral TAVR.

OBJECTIVES: To compare iliofemoral arterial complications with transfemoral transcatheter aortic valve replacement (TF-TAVR) utilizing surgical cutdown versus percutaneous access with closure devices in a randomized trial. BACKGROUND: Major vascular complications following TAVR are a significant risk of the procedure. There are no randomized data comparing whether access method in TF-TAVR influences the risk of such complications. METHODS: From June to December 2011, 30 consecutive patients undergoing TF-TAVR were randomized to either surgical cutdown (C) or percutaneous (P) access. Subjects underwent preoperative CT scans, pre- and post-operative bilateral femoral arterial ultrasound and angiography. The primary endpoint was the composite of major and minor vascular complications at 30 days, as defined by the Valve Academic Research Consortium-2. Multivariate predictors of vascular complications were identified. RESULTS: Of the 30 subjects enrolled, 27 were treated with the randomized method of access as randomized. Iliofemoral complications were observed in eight patients (26.7%; C = 4, P = 4), all of which were dissections and/or stenoses that required percutaneous and/or surgical intervention. There were two (13.3%) major and two (13.3%) minor complications in each group. Two covariates that were significantly associated with vascular complications included female sex and baseline femoral arterial velocity on ultrasound. CONCLUSIONS: While surgical cutdown in TF-TAVR is the recommended access for new centers initiating a TAVR program, this small randomized pilot study suggests the lesser invasive percutaneous method in an experienced center is equivalent in safety to the surgical method. Doppler ultrasound may be useful in predicting complications prior to the procedure.

Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis.

Background- Transcatheter aortic valve replacement (TAVR) has been shown to improve survival compared with standard therapy in patients with severe aortic stenosis who cannot have surgery. The effects of TAVR on health-related quality of life have not been reported from a controlled study. Methods and Results- The Placement of Aortic Transcatheter Valves (PARTNER) trial randomized patients with symptomatic, severe aortic stenosis who were not candidates for surgical valve replacement to TAVR (n=179) or standard therapy (n=179). Health-related quality of life was assessed at baseline and at 1, 6, and 12 months with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the 12-item Short Form-12 General Health Survey (SF-12). The primary end point was the KCCQ overall summary score (range, 0-100; higher=better). At baseline, mean KCCQ summary scores (35±20) and SF-12 physical summary scores (28±7) were markedly depressed. Although the KCCQ summary score improved from baseline in both groups, the extent of improvement was greater after TAVR compared with control at 1 month (mean between-group difference, 13 points; 95% confidence interval, 8-19; P<0.001) with larger benefits at 6 months (mean difference, 21 points; 95% confidence interval, 15-27; P<0.001) and 12 months (mean difference, 26 points; 95% confidence interval, 19-33; P<0.001). At 12 months, TAVR patients also reported higher SF-12 physical and mental health scores with mean differences compared with standard care of 5.7 and 6.4 points, respectively (P<0.001 for both comparisons). Conclusions- Among inoperable patients with severe aortic stenosis, compared with standard care, TAVR resulted in significant improvements in health-related quality of life that were maintained for at least 1 year. Clinical Trials Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

Influence of surgical volume on outcomes in low-risk patients undergoing isolated surgical aortic valve replacement.

BACKGROUND: Intermediate- and high-risk patients undergoing isolated surgical aortic valve replacement have superior outcomes at higher-volume compared with lower-volume hospitals. This study examines the impact of hospital volume on outcomes in low-risk patients undergoing aortic valve replacement. METHODS: Using data from our 29 North Texas hospital collaborative, we examined 2066 low-risk cases (Society of Thoracic Surgeons Predicted Risk of Mortality of ≤3%) undergoing aortic valve replacement surgery between January 1, 2012, and December 31, 2017. Cases from 3 high-volume hospitals (≥200 aortic valve replacement cases total) and 26 low-volume hospitals (<200 cases total) were examined. RESULTS: Some 53.5% of the cases were at high-volume hospitals. No statistical differences were seen in the Predicted Risk of Mortality or pertinent demographics between the high-volume and low-volume hospitals. Significant differences in outcomes were seen between the 2 groups in operative mortality (2.28% vs 1.19%, P = .007), renal failure (2.14% vs 1.00%, P = .003), and readmission within 30 days (9.72% vs 6.25%, P < .001) when comparing low-volume with high-volume hospitals. In patients undergoing aortic valve replacement, undergoing the procedure in a low-volume hospital was an independent predictor for operative mortality (odds ratio, 1.95; 95% confidence interval, 1.20-3.20; P = .008) and renal failure (odds ratio, 2.25; 95% confidence interval, 1.33-3.81; P = .003). CONCLUSIONS: Operative mortality in low-risk patients undergoing aortic valve replacement is higher in low-volume compared with high-volume hospitals. The probability of a major complication, such as renal failure, is also greater in low-volume hospitals. The relationship between volume and outcomes in low-risk patients will require more research to understand the causes and design appropriate interventions.

The safety and efficacy of temporary distal aortic occlusion to facilitate TAVR large-bore arterial closure.

OBJECTIVES: To evaluate the safety and efficacy of temporary distal aortic occlusion (TDAO) for facilitated large-bore arterial closure during transcatheter aortic valve replacement (TAVR). BACKGROUND: Ipsilateral iliac artery occlusion and TDAO have been used to facilitate TAVR delivery sheath access-site closure, but ipsilateral iliac artery occlusion has been associated with arterial complications at the balloon site. METHODS: TDAO was performed in 117 consecutive transfemoral TAVR cases from July 2010 to April 2012. The valve delivery access site was preclosed with suture-mediated closure devices (n = 100) or had a planned surgical cutdown performed (n = 17). TDAO was performed using a 22 mm x 5 cm Tyshak II balloon, which was deployed at the minimum pressure to stop antegrade blood flow in the distal abdominal aorta via a contralateral 8 Fr femoral sheath. This served to occlude iliac run-off as the TAVR delivery sheath access site was closed. Final aortogram with bilateral run-off was performed to evaluate for aortic, iliac, or femoral dissection or rupture, or ilio-femoral vascular complications in accordance with Valve Academic Research Consortium (VARC)-2 criteria. RESULTS: TDAO was successfully performed in all patients with no complications related to the TDAO technique itself. There were vascular complications related to the TAVR procedure. 7 patients (6.0%) had VARC-2 major vascular complications and 16 patients (13.7%) had VARC-2 minor vascular complications. CONCLUSIONS: TDAO is a safe and effective technique to facilitate large-bore arterial closure by both percutaneous and open surgical closure techniques.

Early regression of severe left ventricular hypertrophy after transcatheter aortic valve replacement is associated with decreased hospitalizations.

OBJECTIVES: This study sought to examine the relationship between left ventricular mass (LVM) regression and clinical outcomes after transcatheter aortic valve replacement (TAVR). BACKGROUND: LVM regression after valve replacement for aortic stenosis is assumed to be a favorable effect of LV unloading, but its relationship to improved clinical outcomes is unclear. METHODS: Of 2,115 patients with symptomatic aortic stenosis at high surgical risk receiving TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) randomized trial or continued access registry, 690 had both severe LV hypertrophy (left ventricular mass index [LVMi] ≥ 149 g/m(2) men, ≥ 122 g/m(2) women) at baseline and an LVMi measurement at 30-day post-TAVR follow-up. Clinical outcomes were compared for patients with greater than versus lesser than median percentage change in LVMi between baseline and 30 days using Cox proportional hazard models to evaluate event rates from 30 to 365 days. RESULTS: Compared with patients with lesser regression, patients with greater LVMi regression had a similar rate of all-cause mortality (14.1% vs. 14.3%, p = 0.99), but a lower rate of rehospitalization (9.5% vs. 18.5%, hazard ratio [HR]: 0.50, 95% confidence interval [CI]: 0.32 to 0.78; p = 0.002) and a lower rate of rehospitalization specifically for heart failure (7.3% vs. 13.6%, p = 0.01). The association with a lower rate of rehospitalization was consistent across subgroups and remained significant after multivariable adjustment (HR: 0.53, 95% CI: 0.34 to 0.84; p = 0.007). Patients with greater LVMi regression had lower B-type natriuretic peptide (p = 0.002) and a trend toward better quality of life (p = 0.06) at 1-year follow-up than did those with lesser regression. CONCLUSIONS: In high-risk patients with severe aortic stenosis and severe LV hypertrophy undergoing TAVR, those with greater early LVM regression had one-half the rate of rehospitalization over the subsequent year compared to those with lesser regression.

Transapical aortic valve replacement for severe aortic stenosis: results from the nonrandomized continued access cohort of the PARTNER trial.

BACKGROUND: Transapical (TA) aortic valve replacement was an integral part of the Placement of Transcatheter Aortic Valves (PARTNER) trial. Enrollment during the randomized trial included 104 transapical (premarket approval TA [PMA-TA]) and 92 surgical aortic valve replacements (SAVR) within the TA cohort. On completion of the trial, enrollment continued in a nonrandomized continued access (NRCA) program. We compared the outcomes of NRCA-TA procedures with those of PMA-TA and SAVR. METHODS: In 22 centers, 975 patients underwent TA aortic valve replacement as part of the NRCA registry. Inclusion and exclusion criteria were unchanged from the previously reported PARTNER trial. All patients were followed up for at least 1 year. RESULTS: Thirty-day or in-hospital mortality was 8.8% for the NRCA-TA cohort, compared with 10.6% and 12.0% for the PMA-TA and SAVR patients, respectively (p = 0.54). One-year mortality in the NRCA-TA cohort was 22.1%, not significantly lower than the mortality in PMA-TA and SAVR patients at 29.0% and 25.3%, respectively (p = 0.27). Thirty-day or in-hospital stroke was 2.2% among NRCA-TA patients in contrast to the 6.7% stroke rate observed in the PMA-TA group and 5.4% in SAVR patients (p = 0.008). Lower rates of neurologic adverse events in the NRCA-TA group persisted at 1 year compared with the PMA-TA and SAVR patients. CONCLUSIONS: Among the 975 patients in the NRCA-TA cohort, rates of major outcomes including death and stroke compared favorably with outcomes of PMA-TA and SAVR patients enrolled in the PARTNER trial. This trend toward improved outcomes may be attributed to improved patient selection, individual centers surmounting the procedural learning curve, and refinements in surgical technique.

Temporary aortic occlusion to facilitate large-bore arterial closure.

Percutaneous closure of large-bore arterial sheaths remains a clinical challenge. We report a case of facilitated large-bore closure using a low-profile valvuloplasty balloon for aortic occlusion. This technique enhanced percutaneous closure device deployment and improved hemostasis during arteriotomy closure.

Method for coronary angiography in morbidly obese patients.

Cardiac catheterization in morbidly obese patients is difficult. In addition to problems regarding vascular access and radiographic penetration of the chest, the engineering parameters and physical limitations of the table and its supporting structures may limit these patients' ability to undergo clinically indicated coronary angiography. We describe a method for cardiac catheterization in which much of the obese patient's body weight is supported on a stretcher placed at right angles to the catheterization table, with only the thorax on the table under the image intensifier. Using this method, five consecutive successful diagnostic procedures and one coronary stent procedure have been performed without complication. Limitations of this procedure include inability to achieve the normal variety of angiographic views due to constraints on image intensifier rotation and skew.