Outcomes of a Rapid Deployment Aortic Valve Versus Its Conventional Counterpart: A Propensity-Matched Analysis.

OBJECTIVE: The aim of this study was to compare outcomes after rapid-deployment aortic valve replacement (RDAVR) and conventional aortic valve replacement (AVR) from two studies. METHODS: Patients who underwent RDAVR (INTUITY valve) in the prospective, 5-year, single-arm multicenter TRITON study, or conventional AVR (Perimount Magna Ease valve) in the prospective Perimount Magna Ease postmarket study, were propensity score matched and compared for procedural, hemodynamic, safety, and clinical outcomes. RESULTS: Matched RDAVR (n = 106) and conventional AVR (n = 106) patients had similar baseline characteristics (mean ± SD age, 72.8 ± 7.6 vs 72.5 ± 7.4 years; male 59.4% vs 61.3%) and procedures (concomitant procedures: 41.5% vs 50.9%). Mean ± SD aortic cross-clamp time was significantly shorter in RDAVR than AVR patients (51.8 ± 20.9 vs 73.9 ± 33.2 minutes; P < 0.001), as was mean cardiopulmonary bypass time (82.8 ± 34.2 vs 102.4 ± 41.7 minutes; P < 0.001). At 1 year, RDAVR patients showed significantly lower mean ± SD and peak aortic valve gradients (9.0 ± 3.4 and 17.0 ± 6.2 mm Hg, respectively) than conventional AVR patients (13.4 ± 5.5 and 24.2 ± 10.8 mm Hg, respectively; all P < 0.001). Patient-prosthesis mismatch was significantly less common with RDAVR than with AVR [overall: 16/66 (24.2%) vs 46/76 (60.5%); P = 0.007; severe: 2/66 (3.0%) vs 13/76 (17.1%)]. There were no significant differences between the RDAVR and AVR groups regarding 30-day safety endpoints. Survival rates in the RDAVR and conventional AVR groups were, respectively, 99.1% and 100.0% at 30 days, 97.1% and 95.1% at 1 year, and 93.3% and 94.1% at 3 years (P = nonsignificant). CONCLUSIONS: In this retrospective study with matched populations, the RDAVR with the INTUITY valve system provided superior procedural and hemodynamic outcomes than a standard bioprosthesis without compromising safety.

One-year outcomes after rapid-deployment aortic valve replacement.

OBJECTIVE: The goals of rapid-deployment aortic valve replacement include facilitation of minimally invasive surgery and reduced aortic crossclamp time. We report the short-term outcomes of a series of 493 patients undergoing rapid-deployment aortic valve replacement with the EDWARDS INTUITY valve system (Edwards Lifesciences, LLC, Irvine, Calif). METHODS: Assessing Standard oF Care and Clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, Active, pOst-market surveillaNce Study was a prospective, multicenter (n = 26) European registry designed to evaluate the safety and performance of the valve system. During rapid-deployment aortic valve replacement, device technical success and crossclamp time were assessed. Procedural outcomes, hemodynamic performance, and various adverse events and clinical outcomes were evaluated up to 2 years. RESULTS: Between 2012 and 2014, 493 of 517 enrolled patients successfully received implants with the study valve (95.4% technical success). Mean crossclamp times for 163 full sternotomies, 128 mini-upper sternotomies, and 36 right anterior thoracotomies isolated aortic valve replacements were 47.3, 52.0, and 73.3 minutes, respectively. Mean follow-up was 1.8 years, with 870 total patient-years of follow-up. Mean effective orifice area increased from 0.72 (baseline) to 1.88 cm2, and mean pressure gradient decreased from 47.6 to 9.6 mm Hg (1 year). Mean effective orifice area index increased (0.39-1.01 cm2/m2), and 28 of 287 patients (9.8%) exhibited severe prosthesis-patient mismatch at 1 year. After 1 year, 68.1% and 21.7% of patients were in New York Heart Association class I and II, respectively. Freedom from death, major bleeding, major perivalvular leak, reoperation, and device explant at 1 year were 0.935, 0.939, 0.976, 0.975, and 0.983, respectively. CONCLUSIONS: These results demonstrate commendable safety and performance of the test valve system over the short term in a broad European setting.

Long-term outcomes of a rapid deployment aortic valve: data up to 5 years.

OBJECTIVES: Rapid deployment aortic valve replacement (AVR) has been developed to facilitate minimally invasive approaches for cardiac surgery and shorten procedural times. TRITON is a prospectively designed study to assess safety and efficacy of rapid deployment AVR with Edwards INTUITY valve system. This report presents the 5-year outcomes of the TRITON trial. METHODS: A total of 295 patients with aortic valve stenosis were enrolled in the TRITON trial and 287 patients received the study valve. Procedural, early (≤30 days) and late (>30 days) outcomes were collected. Valve haemodynamic performance was evaluated at specified time points by an independent Echocardiography Core Laboratory and clinical events adjudicated by an independent Clinical Events Committee. RESULTS: Mean age was 75.3 ± 6.7 years. A total of 158 patients underwent isolated AVR and 129 patients underwent AVR with concomitant procedures. The 5-year survival rates were 85.7 ± 3.4% and 75.2 ± 4.9% for isolated AVR and concomitant AVR, respectively. Overall, freedom from valve-related death at 5 years was 98.2 ± 0.8%. At 5 years, the valve effective orifice area was 1.6 ± 0.3 cm 2 , mean gradient was 10.5 ± 5.4 mmHg and peak gradient was 18.9 ± 9.3 mmHg. CONCLUSIONS: The 5-year outcomes of the TRITON trial demonstrate acceptable long-term safety and excellent haemodynamic performance of rapid deployment AVR with the Edwards INTUITY valve system. CLINICALTRIALS.GOV: NCT01445171.

Prevalence of isolated uncontrolled systolic blood pressure among treated hypertensive patients in primary care in Belgium: results of the I-inSYST survey.

OBJECTIVE: To evaluate the prevalence of isolated uncontrolled systolic blood pressure (on-treatment isolated systolic hypertension) in treated hypertensive patients and identify the characteristics and treatment strategy in these patients. METHODS: Prospective cross-sectional survey in primary care. Participating physicians enrolled more than 13 consecutive treated hypertensive patients. Patients were considered to have isolated systolic hypertension when systolic blood pressure was at least 140 mmHg and diastolic blood pressure was less than 90 mmHg. RESULTS: On-treatment isolated systolic hypertension occurred in 28% of evaluable patients (n = 11562) and in 36% of uncontrolled patients (n = 9080). Among the isolated systolic hypertension and among other uncontrolled patients, 53% and 47%, respectively, used more than one antihypertensive drug class. beta-Blockers were the most frequently prescribed antihypertensive drugs. Patients with isolated uncontrolled systolic blood pressure were more frequently treated with diuretics (43 vs. 39%) and angiotensin II receptor antagonists (23 vs. 17%). Despite blood pressure being under control in only 21% of the patients, hypertension treatment was not changed in 46% of patients with isolated uncontrolled systolic blood presssure vs. 14% of patients with both uncontrolled systolic and diastolic blood pressure. CONCLUSION: In Belgium, the prevalence of on-treatment isolated systolic hypertension in treated hypertensive patients, was 28%. The goal blood pressure was likely not reached in most patients due to inadequate treatment. The overall control rate was worse for systolic than for diastolic blood pressure. Furthermore, antihypertensive treatment was less frequently adapted in patients with isolated uncontrolled systolic blood pressure than in those patients with both uncontrolled systolic and diastolic blood pressure.