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The aim of this study was to investigate bipolar radiofrequency renal denervation in patients with hypertension not receiving medications at baseline.A blood pressure-reducing effect of renal denervation has been difficult to isolate in clinical investigations.REDUCE HTN: REINFORCE (Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension) was a randomized, sham-controlled multicenter trial. Patients with office systolic blood pressure (SBP) of 150 to 180 mm Hg and average 24-h ambulatory SBP of 135 to 170 mm Hg after medication washout underwent bipolar radiofrequency renal denervation or a sham procedure. The planned outcome was 8-week change in 24-h ambulatory SBP. Enrollment was terminated for apparent futility before a sufficient sample for powered efficacy comparisons was enrolled. Safety assessments included all-cause death, renal failure, severe hypotension or syncope, hypertensive crisis, and renal artery stenosis.Baseline 24-h blood pressure was 148.3 ± 10.9/85.7 ± 9.1 mm Hg for the denervation group (n = 34, mean age 58.5 ± 10.1 years, 47% women) and 149.1 ± 7.2/86.4 ± 9.8 mm Hg for the control group (n = 17, mean age 58.2 ± 9.8 years, 24% women). At 8 weeks, mean 24-h SBP reductions for the renal denervation and control groups were -5.3 mm Hg (95% confidence interval [CI]: -8.8 to -1.8 mm Hg) and -8.5 mm Hg (95% CI: -13.3 to -3.8 mm Hg), respectively (difference 3.3 mm Hg; 95% CI: -2.8 to 9.3 mm Hg; p = 0.30). Antihypertensive medications could then be added. By 6 months, decreases in SBP were greater for the denervation group, yielding between-group differences of -7.2 mm Hg (95% CI: -15.2 to 0.8 mm Hg; p = 0.08), -9.7 mm Hg (95% CI: -17.7 to -1.7 mm Hg; p = 0.02), and -11.4 mm Hg (95% CI: -19.2 to -3.7 mm Hg; p 0.01) for 24-h, daytime ambulatory, and office measurements, respectively. Through 12 months, 1 patient (renal denervation group) had a hypertensive urgency requiring immediate management, and 1 experienced progression of renal artery stenosis.Future studies of radiofrequency renal denervation must anticipate delayed treatment effects. (Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension [REDUCE HTN: REINFORCE]; NCT02392351).

An increasing number of patients have refractory angina despite optimal medical therapy and are without further revascularization options. Preclinical studies indicate that human CD34

Rationale: A growing number of patients with coronary disease have refractory angina. Preclinical and early-phase clinical data suggest that intramyocardial injection of autologous CD34+ cells can improve myocardial perfusion and function. Objective: Evaluate the safety and bioactivity of intramyocardial injections of autologous CD34+ cells in patients with refractory angina who have exhausted all other treatment options. Methods and Results: In this prospective, double-blind, randomized, phase II study (ClinicalTrials.gov identifier: NCT00300053), 167 patients with refractory angina received 1 of 2 doses (1×10 5 or 5×10 5 cells/kg) of mobilized autologous CD34+ cells or an equal volume of diluent (placebo). Treatment was distributed into 10 sites of ischemic, viable myocardium with a NOGA mapping injection catheter. The primary outcome measure was weekly angina frequency 6 months after treatment. Weekly angina frequency was significantly lower in the low-dose group than in placebo-treated patients at both 6 months (6.8±1.1 versus 10.9±1.2, P =0.020) and 12 months (6.3±1.2 versus 11.0±1.2, P =0.035); measurements in the high-dose group were also lower, but not significantly. Similarly, improvement in exercise tolerance was significantly greater in low-dose patients than in placebo-treated patients (6 months: 139±151 versus 69±122 seconds, P =0.014; 12 months: 140±171 versus 58±146 seconds, P =0.017) and greater, but not significantly, in the high-dose group. During cell mobilization and collection, 4.6% of patients had cardiac enzyme elevations consistent with non-ST segment elevation myocardial infarction. Mortality at 12 months was 5.4% in the placebo-treatment group with no deaths among cell-treated patients. Conclusions: Patients with refractory angina who received intramyocardial injections of autologous CD34+ cells (10 5 cells/kg) experienced significant improvements in angina frequency and exercise tolerance. The cell-mobilization and -collection procedures were associated with cardiac enzyme elevations, which will be addressed in future studies.

Introduction: Percutaneous balloon mitral valvuloplasty (PBMV) is a well-established alternative to commissurotomy and is recommended for patients with Mitral stenosis (MS) and echocardiographic (ECHO) score b8 and no calcified mitral valves. However, the question remains whether simultaneous intracardiac echocardiography (ICE) is useful to perform PBMV in suboptimal candidates without provoking excessive mitral regurgitation (MR). Materials and Methods: Fifty-seven consecutive PBMV procedures under ICE guidance were performed under local anesthesia and mild sedation between May 2004 and October 2008 at University of Alabama at Birmingham. Left femoral vein was used for ICE insertion while the right was used for transseptal access. Transthoracic echocardiography was used to assess the mitral valve pre and post PBMV. The corresponding preand postPBMVmitral valve areas (MVA) were calculated. Inhospital adverse clinical events were collected. Results: There were 10 (18%) men. The mean age was 53.9±14 years (range, 26–94 years). Two thirds had ECHO score N8, and 33% had moderate to severe MR before PBMV. After PBMV, MVA increased from 1.1±0.29 cm to 1.8±0.9 cm (Pb.005) by planimetry, from 1.25±0.58 cm to 1.97±0.57 cm (Pb.005) by Gorlin's formula. The mean mitral valve gradient decreased from 14±5 mm Hg to 7±3 mm Hg (Pb.005). None had cardiac tamponade or died during the procedure. Fifty-two patients (91.2%) had successful PBMV without in-hospital adverse events. Three (5.2%) required MVR. Two patients developed flail MV leaflet due to rupture of chordae. The third with Grade 3 MR prior to PBMV had progressively worsening symptoms for 7 days requiring MVR. One patient, with prePBMV valve area of 0.6 cm had improvement in MVA to 1.4 cm but developed MRSA sepsis and acute renal failure, which resolved during her hospital stay. Conclusion: MS patients with poor MVanatomy and moderate to high risk for PBMV have been traditionally relegated to medical therapy. With ICE guidance, PBMV can be extended to these patients with unsuitable MV anatomy with reasonable procedural success and safety. To our knowledge, this is the largest case series reporting the use of ICE to facilitate PBMV in such moderate to high-risk patients

Hepatocyte growth factor (HGF) has shown promise in treating patients with critical limb ischemia (CLI). We performed this phase II study to assess the safety and efficacy of the intramuscular (IM) injection of VM202, plasmid DNA expressing 2 isoforms of HGF, in CLI patients. We enrolled 52