John Heiser

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.).

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.)

Cardiac Surgeons and the Quality Movement: the Michigan Experience

The Michigan Society of Thoracic and Cardiovascular Surgeons created a voluntary quality collaborative with all the cardiac surgeons in the state and all hospitals doing adult cardiac surgery. Utilizing this collaborative over the last 3 years and creating a unique relationship with a payor, an approach to processes and outcomes has produced improvements in the quality of care for cardiac patients in the state of Michigan.

Prosthesis–patient mismatch in high-risk patients with severe aortic stenosis: A randomized trial of a self-expanding prosthesis

OBJECTIVES We compared the incidence of prosthesis-patient mismatch (PPM) between transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis and surgical aortic valve replacement (SAVR) in the CoreValve US High Risk Pivotal Trial. We sought to determine the influence of PPM on clinical outcomes. METHODS Patients with severe aortic stenosis and at increased risk for surgery were randomized 1:1 to TAVR or SAVR. Postoperative PPM was defined by the effective orifice area index (EOAi) as severe PPM (EOAi ≤ 0.65 cm(2)/m(2)) and no severe PPM (EOAi > 0.65 cm(2)/m(2)); clinical outcomes were analyzed in the TAVR arm (n = 389) and SAVR arm (n = 353). Left ventricular mass index and regression were analyzed at baseline and 1 year. RESULTS The incidence of severe PPM in the SAVR group at 1 year was 25.7% versus 6.2% in the TAVR group (P < .0001). Left ventricular mass index regression at 1 year was 6.8% for TAVR and 15.1% for SAVR in patients with severe PPM. At 1 year the rate of all-cause mortality and acute kidney injury were significantly greater in all patients (TAVR + SAVR) with severe PPM compared with no severe PPM (20.6% vs 12.0% [P = .0145] for death and 19.2% vs 8.5% [P = .0008] for acute kidney injury). CONCLUSIONS In patients with high surgical risk and severe aortic stenosis, severe PPM is more common in patients treated with SAVR than those treated with TAVR. Patients with severe PPM are a greater risk for death and acute kidney injury than patients without severe PPM.

Self-expanding transcatheter aortic valve replacement using alternative access sites in symptomatic patients with severe aortic stenosis deemed extreme risk of surgery

OBJECTIVES The CoreValve Extreme Risk US Pivotal Trial enrolled patients with symptomatic severe aortic stenosis deemed unsuitable for surgical aortic valve replacement. Implants were attempted using transfemoral access (n = 489) or an alternative access (n = 150). In present analysis, we sought to examine the safety and efficacy of CoreValve transcatheter aortic valve replacement using alternative access. METHODS The present study included 150 patients with prohibitive iliofemoral anatomy who were treated with the CoreValve transcatheter heart valve delivered by way of the subclavian artery (n = 70) or a direct aortic approach (n = 80). The echocardiograms were read by an independent core laboratory. The primary endpoint was all-cause mortality or major stroke at 12 months. RESULTS The preoperative aortic valve area was 0.72 ± 0.27 cm(2) and mean aortic valve gradient was 49.5 ± 17.0 mm Hg. After the transcatheter aortic valve replacement, the effective aortic valve area was 1.82 ± 0.64 cm(2) at 1 month and 1.85 ± 0.51 cm(2) at 12 months. The mean aortic valve gradient was 9.7 ± 5.8 mm Hg at 30 days and 9.5 ± 5.7 mm Hg at 12 months. The death or major stroke rate was 15.3% at 30 days and 39.4% at 12 months. The individual rate of all-cause mortality and major stroke was 11.3% and 7.5% at 30 days and 36.0% and 9.1% at 12 months. CONCLUSIONS These data demonstrate that the CoreValve transcatheter heart valve delivered by an alternative access provides a suitable alternative for treatment of extreme risk patients with symptomatic severe aortic stenosis, who have prohibitive iliofemoral anatomy and no surgical options.

Outcomes in the Randomized CoreValve US Pivotal High Risk Trial in Patients With a Society of Thoracic Surgeons Risk Score of 7% or Less

Importance Transcatheter aortic valve replacement (TAVR) is now a well-accepted alternative to surgical AVR (SAVR) for patients with symptomatic aortic stenosis at increased operative risk. There is interest in whether TAVR would benefit patients at lower risk. Objective The Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) has trended downward in US TAVR trials and the STS/American College of Cardiology Transcatheter Valve Therapy Registry. We hypothesized that if the Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) alone is sufficient to define decreased risk, the contribution to survival based on the degree of invasiveness of the TAVR procedure will decrease, making it more difficult to show improved survival and benefit over SAVR. Design, Setting, and Participants The CoreValve US Pivotal High Risk Trial was a multicenter, randomized, noninferiority trial. This retrospective analysis evaluated patients who underwent an attempted implant and had an STS PROM of 7% or less. The trial was performed at 45 US sites. Patients had severe aortic stenosis and were at increased surgical risk based on their STS PROM score and other risk factors. Interventions Eligible patients were randomly assigned (1:1) to self-expanding TAVR or to SAVR. Main Outcomes and Measures We retrospectively stratified patients by the overall median STS PROM score (7%) and analyzed clinical outcomes and quality of life using the Kansas City Cardiomyopathy Questionnaire in patients with an STS PROM score of 7% or less. Results The mean (SD) ages were 81.5 (7.6) years for the TAVR group and 81.2 years (6.6) for the SAVR group. A little more than half were men (57.9% in the TAVR group and 55.8% in the SAVR group). Of 750 patients who underwent attempted implantation, 383 (202 TAVR and 181 SAVR) had an STS PROM of 7% or less (median [interquartile range]: TAVR, 5.3% [4.3%-6.1%]; SAVR, 5.3% [4.1%-5.9%]). Two-year all-cause mortality for TAVR vs SAVR was 15.0% (95% CI, 8.9-10.0) vs 26.3% (95% CI, 19.7-33.0) (log rank P = .01). The 2-year rate of stroke for TAVR vs SAVR was 11.3% vs 15.1% (log rank P = .50). Quality of life by the Kansas City Cardiomyopathy Questionnaire summary score showed significant and equivalent increases in both groups at 2 years (mean [SD] TAVR, 20.0 [25.0]; SAVR, 18.6 [23.6]; P = .71; both P < .001 compared with baseline). Medical benefit, defined as alive with a Kansas City Cardiomyopathy Questionnaire summary score of at least 60 and a less than 10-point decrease from baseline, was similar between groups at 2 years (TAVR, 51.0%; SAVR, 44.4%; P = .28). Conclusions and Relevance Self-expanding TAVR compares favorably with SAVR in high-risk patients with STS PROM scores traditionally considered intermediate risk. Trial Registration Clinicaltrials.gov Identifier: NCT01240902.

Aortic Valve Replacement in Octogenarians With Prior Cardiac Surgery

BACKGROUND Transcatheter aortic valve implantation (TAVI) has been advocated for very elderly patients with aortic stenosis, and prior cardiac surgery as a less invasive treatment option. Although surgical aortic valve replacement (AVR) is safe and effective in selected elderly patients, the perioperative and mid-term outcomes of AVR in very elderly with prior cardiac surgery are unknown. METHODS The Society of Thoracic Surgeons (STS) Database at our center enrolled 3,735 patients after AVR since 1997. In this time interval, we identified 61 patients 80 years and older who underwent AVR for severe AS or failed aortic bioprosthesis after having prior cardiac surgery. All clinical parameters were derived from the STS database. Follow-up mortality was assessed using the Social Security Death Index. RESULTS The average age of the patients was 83 ± 2 years, 77% were male, and 75% underwent an isolated coronary artery bypass graft (CABG) as their first cardiac procedure. The mean ejection fraction was 0.53 ± 0.13. The CABG was performed concurrently in 49% of patients at the time of redo sternotomy and AVR. Stented bioprosthesis was implanted in 61% of patients and stentless in 39%. Perioperative mortality was 1.6% (1 of 61). One, 3, 5, and 7 year survival rates were 85%, 69%, 63%, and 43%, respectively. Patients with AVR only had similar survival to patients who underwent concomitant AVR and CABG. Type of aortic prosthesis did not influence postoperative survival. CONCLUSIONS In selected patients over the age of 80 with history of prior cardiac surgery, AVR can be performed safely with very good mid-term outcomes. Age alone should not be exclusion criteria for surgical AVR in octogenarians with prior cardiac surgery.

Five-year real world outcomes of GeoForm ring implantation in patients with ischemic mitral regurgitation.

BACKGROUND Reductive ring annuloplasty represents the current standard surgical therapy for ischemic mitral regurgitation (IMR); however, the clinical results have been suboptimal. Etiology-specific prostheses such as the GeoForm annuloplasty ring have been designed to better address the annular and subvalvular perturbations associated with IMR. However, clinical experience is limited, and mid-term results are lacking. METHODS We reviewed the clinical outcomes of 86 patients who had undergone implantation of a GeoForm ring at our center from 2005 to 2011. Perioperative mortality and clinical parameters were derived from The Society of Thoracic Surgeons database. Follow-up survival was assessed using the Social Security Death Index. Surviving patients were interviewed by telephone for valve-specific follow-up data and to complete the Medical Outcomes Study, short-form, 36-item, quality-of-life questionnaire. RESULTS The mean grade of IMR preoperatively was 3.1±0.8 (range, 1-4+), 0.2±0.4 in the immediate postoperative period, and 0.7±0.7 at the last mean follow-up point of 41 months; only 2 patients developed ≥2+IMR during the follow-up period, for a 5-year freedom from recurrent 2+ IMR of 86%. The mean left ventricular end-diastolic and end-systolic diameters decreased from before to after surgery from 6.0±0.0 cm to 5.3±09 cm and 5.0±0.9 cm to 4.3±1.1 cm, respectively (P<.001). Perioperative mortality was 5.8% (5 of 86), and 1-, 3-, and 5-year survival was 87%, 81%, and 75%, respectively. At the last follow-up point, 80% of patients were in New York Heart Association class I and II, and their quality of life was equal to, or better than, age-matched controls from the general population. CONCLUSIONS Implantation of the GeoForm ring offers very good control of IMR, with low rate of recurrent IMR at mid-term follow-up. The use of this prosthesis was associated with good perioperative mortality, mid-term survival, and quality of life.

Transcatheter Aortic Valve Replacement in Patients With Severe Mitral or Tricuspid Regurgitation at Extreme Risk for Surgery

Objectives: Patients with symptomatic severe aortic stenosis and severe mitral regurgitation or severe tricuspid regurgitation were excluded from the major transcatheter aortic valve replacement trials. We studied these 2 subgroups in patients at extreme risk for surgery in the prospective, nonrandomized, single‐arm CoreValve US Expanded Use Study. Methods: The primary end point was all‐cause mortality or major stroke at 1 year. A favorable medical benefit was defined as a Kansas City Cardiomyopathy Questionnaire overall summary score greater than 45 at 6 months and greater than 60 at 1 year and with a less than 10‐point decrease from baseline. Results: There were 53 patients in each group. Baseline characteristics for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were age 84.2 ± 6.4 years and 84.9 ± 6.5 years; male, 29 (54.7%) and 22 (41.5%), and mean Society of Thoracic Surgeons score 9.9% ± 5.0% and 9.2% ± 4.0%, respectively. Improvement in valve regurgitation from baseline to 1 year occurred in 72.7% of the patients with severe mitral regurgitation and in 61.8% of patients with severe tricuspid regurgitation. A favorable medical benefit occurred in 31 of 47 patients (66.0%) with severe mitral regurgitation and 33 of 47 patients (70.2%) with severe tricuspid regurgitation at 6 months, and in 25 of 44 patients (56.8%) with severe mitral regurgitation and 24 of 45 patients (53.3%) with severe tricuspid regurgitation at 1 year. All‐cause mortality or major stroke for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were 11.3% and 3.8% at 30 days and 21.0% and 19.2% at 1 year, respectively. There were no major strokes in either group at 1 year. Conclusions: Transcatheter aortic valve replacement in patients with severe mitral regurgitation or severe tricuspid regurgitation is reasonable and safe and leads to improvement in atrioventricular valve regurgitation.

Self-Expanding Transcatheter Aortic Valve Replacement or Surgical Valve Replacement in High-Risk Patients: 5-Year Outcomes

ISS Fro syl Ce D pa dio Ca og olo Un syl De of BACKGROUND The CoreValve US Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality–risk patients. OBJECTIVES The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability. METHODS Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient