Impact of varying degrees of renal dysfunction on transcatheter and surgical aortic valve replacement

BackgroundRenal impairment portends adverse outcomes in patients undergoing valvular heart surgery. The relationship between renal dysfunction in patients undergoing transcatheter aortic valve replacement (TAVR) is incompletely understood.MethodsA retrospective review of 1336 patients undergoing surgical aortic valve replacement (SAVR; 2002-2012) and 321 patients undergoing TAVR (2007-2012) was performed. Patients were divided into 3 glomerular filtration rate (GFR) groups: GFR greater than 60 mL/min, GFR 31 to 60 mL/min, and GFR 30 mL/min or less. Logistic and linear regression analysis was performed to estimate the TAVR effect on outcomes. Risk adjustments were made using the Society for Thoracic Surgeons (STS) predicted risk of mortality (PROM).ResultsTAVR patients were older (82 vs 65 years; P < .001), had a poorer ejection fraction (48% vs 53%; P < .001), were more likely female (45% vs 41%; P = .23), and had a higher STS PROM (11.9% vs 4.6%; P < .001). In-hospital mortality rates for TAVR and SAVR were 3.5% and 4.1%, respectively (P = .60), a result that marginally favors TAVR after risk adjustment (adjusted odds ratio = .52, P = .06). In SAVR patients, worsening preoperative renal failure was associated with increased in-hospital mortality (P = .004) and hospital (P < .001) and intensive care unit (ICU) (P < .001) lengths of stay. In contrast, worsening renal function did not influence in-hospital mortality (P = .78) and hospital (P < .23) and ICU (P = .88) lengths of stay in TAVR patients.ConclusionsWorsening renal function was associated with increased in-hospital mortality, hospital length of stay, and ICU length of stay in SAVR patients, but not in TAVR patients. This unexpected finding may have important clinical implications in patients with aortic stenosis and preoperative renal dysfunction

Transcatheter Laceration of Aortic Leaflets to Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement: Concept to First-in-Human

OBJECTIVES: This study sought to develop a novel technique called bioprosthetic or native aortic scallop intentional laceration to prevent coronary artery obstruction (BASILICA). BACKGROUND: Coronary artery obstruction is a rare but fatal complication of transcatheter aortic valve replacement (TAVR). METHODS: We lacerated pericardial leaflets in vitro using catheter electrosurgery, and tested leaflet splaying after benchtop TAVR. The procedure was tested in swine. BASILICA was then offered to patients at high risk of coronary obstruction from TAVR and ineligible for surgical aortic valve replacement. BASILICA used marketed devices. Catheters directed an electrified guidewire to traverse and lacerate the aortic leaflet down the center line. TAVR was performed as usual. RESULTS: TAVR splayed lacerated bovine pericardial leaflets. BASILICA was successful in pigs, both to left and right cusps. Necropsy revealed full length lacerations with no collateral thermal injury. Seven patients underwent BASILICA on a compassionate basis. Six had failed bioprosthetic valves, both stented and stent-less. Two had severe aortic stenosis, including 1 patient with native disease, 3 had severe aortic regurgitation, and 2 had mixed aortic valve disease. One patient required laceration of both left and right coronary cusps. There was no hemodynamic compromise in any patient following BASILICA. All patients had successful TAVR, with no coronary obstruction, stroke, or any major complications. All patients survived to 30 days. CONCLUSIONS: BASILICA may durably prevent coronary obstruction from TAVR. The procedure was successful across a range of presentations, and requires further evaluation in a prospective trial. Its role in treatment of degenerated TAVR devices remains untested

Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial.

The SPYRAL HTN-OFF MED Pivotal trial ( https://clinicaltrials.gov/ct2/show/NCT02439749 ) demonstrated significant reductions in blood pressure (BP) after renal denervation (RDN) compared to sham control in the absence of anti-hypertensive medications. Prior to the 3-month primary endpoint, medications were immediately reinstated for patients who met escape criteria defined as office systolic BP (SBP) ≥ 180 mmHg or other safety concerns. Our objective was to compare the rate of hypertensive urgencies in RDN vs. sham control patients. Patients were enrolled with office SBP ≥ 150 and < 180 mmHg, office diastolic BP (DBP) ≥ 90 mmHg and mean 24 h SBP ≥ 140 and < 170 mmHg. Patients had been required to discontinue any anti-hypertensive medications and were randomized 1:1 to RDN or sham control. In this post-hoc analysis, cumulative incidence curves with Kaplan-Meier estimates of rate of patients meeting escape criteria were generated for RDN and sham control patients. There were 16 RDN (9.6%) and 28 sham control patients (17.0%) who met escape criteria between baseline and 3 months. There was a significantly higher rate of sham control patients meeting escape criteria compared to RDN for all escape patients (p = 0.032), as well as for patients with a hypertensive urgency with office SBP ≥ 180 mmHg (p = 0.046). Rate of escape was similar between RDN and sham control for patients without a measured BP exceeding 180 mmHg (p = 0.32). In the SPYRAL HTN-OFF MED Pivotal trial, RDN patients were less likely to experience hypertensive urgencies that required immediate use of anti-hypertensive medications compared to sham control

Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial

IMPORTANCE: Two initial sham-controlled trials demonstrated that ultrasound renal denervation decreases blood pressure (BP) in patients with mild to moderate hypertension and hypertension that is resistant to treatment. OBJECTIVE: To study the efficacy and safety of ultrasound renal denervation without the confounding influence of antihypertensive medications in patients with hypertension. DESIGN, SETTING, AND PARTICIPANTS: Sham-controlled, randomized clinical trial with patients and outcome assessors blinded to treatment assignment that was conducted between January 14, 2019, and March 25, 2022, at 37 centers in the US and 24 centers in Europe, with randomization stratified by center. Patients aged 18 years to 75 years with hypertension (seated office systolic BP [SBP] ≥140 mm Hg and diastolic BP [DBP] ≥90 mm Hg despite taking up to 2 antihypertensive medications) were eligible if they had an ambulatory SBP/DBP of 135/85 mm Hg or greater and an SBP/DBP less than 170/105 mm Hg after a 4-week washout of their medications. Patients with an estimated glomerular filtration rate of 40 mL/min/1.73 m2 or greater and with suitable renal artery anatomy were randomized 2:1 to undergo ultrasound renal denervation or a sham procedure. Patients were to abstain from antihypertensive medications until the 2-month follow-up unless prespecified BP criteria were exceeded and were associated with clinical symptoms. INTERVENTIONS: Ultrasound renal denervation vs a sham procedure. MAIN OUTCOMES AND MEASURES: The primary efficacy outcome was the mean change in daytime ambulatory SBP at 2 months. The primary safety composite outcome of major adverse events included death, kidney failure, and major embolic, vascular, cardiovascular, cerebrovascular, and hypertensive events at 30 days and renal artery stenosis greater than 70% detected at 6 months. The secondary outcomes included mean change in 24-hour ambulatory SBP, home SBP, office SBP, and all DBP parameters at 2 months. RESULTS: Among 1038 eligible patients, 150 were randomized to ultrasound renal denervation and 74 to a sham procedure (mean age, 55 years [SD, 9.3 years]; 28.6% female; and 16.1% self-identified as Black or African American). The reduction in daytime ambulatory SBP was greater with ultrasound renal denervation (mean, -7.9 mm Hg [SD, 11.6 mm Hg]) vs the sham procedure (mean, -1.8 mm Hg [SD, 9.5 mm Hg]) (baseline-adjusted between-group difference, -6.3 mm Hg [95% CI, -9.3 to -3.2 mm Hg], P < .001), with a consistent effect of ultrasound renal denervation throughout the 24-hour circadian cycle. Among 7 secondary BP outcomes, 6 were significantly improved with ultrasound renal denervation vs the sham procedure. No major adverse events were reported in either group. CONCLUSIONS AND RELEVANCE: In patients with hypertension, ultrasound renal denervation reduced daytime ambulatory SBP at 2 months in the absence of antihypertensive medications vs a sham procedure without postprocedural major adverse events. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03614260