Durability of the Blood Pressure Effects of Renal Pelvis Denervation in Patients with Hypertension During a 12-Month Observation.

INTRODUCTION: We previously completed a trial of renal pelvic denervation for treating hypertension that reduced blood pressure by the 2-month primary endpoint. However, information on the durability of effectiveness is a critical requirement for device therapy and we now report data up to 12 months. METHODS: This was an open label single-arm feasibility study in patients with increased blood pressure despite taking an average of 2.7 medications. The key endpoint reported here was ambulatory blood pressure at 12 months following renal pelvic denervation. RESULTS: In the 17 patients (mean age 56) studied, there was a reduction from the baseline of 148 + 8.7 mmHg in the primary endpoint of mean daytime systolic blood pressure at 12 months of 19.1 (26.7, 11.6) mmHg, P<0.001, as compared with the 2-month result of 19.4 (24.9, 14.0) mmHg. The 24-hour systolic blood pressure fell by 19.3 (26.7, 11.9), P<0.001, and nighttime systolic fell by 18.7 (27.5, 9.8), P<0.001, mmHg at 12 months. Diastolic pressures also fell significantly from baseline at 12 months. As well, automated office systolic blood pressure was reduced from the baseline of 156.5 + 12.3 by 24.8 (33.2. 16.8) mmHg, P<0.001, at 12 months as compared with 22.4 (31.5, 13.3) at 2-months. . All blood pressure changes at 12 months were not different from those at 2 months, thus confirming the durability of the procedure. There were no serious procedural, clinical or laboratory adverse events related to the intervention. Serum creatinine fell from 1.03 + 0.22 to 0.82 + 0.16 mg/dl and estimated glomerular filtration rate rose from 79.6 + 17.8 to 96.3 + 16.4 ml/min/1.73m2 by 12 months, again sustaining effects seen at 2 months. DISCUSSION/CONCLUSION: These findings provide evidence that the significant blood pressure-lowering effects of renal pelvis denervation are durable and safe for at least one year and provide the basis for a pivotal randomized blinded trial to further define the safety and effectiveness of this procedure.

Impact of Renal Pelvic Denervation on Systemic Hemodynamics and Neurohumoral Changes in a Porcine Model.

INTRODUCTION: The blood pressure (BP) response to arterial renal denervation (RDN) is variable. METHODS: This study examined the effectiveness of renal pelvic denervation (RPD) on BP, heart rate (HR), norepinephrine (NE), and histopathology in 42 swine. NE levels were measured immediately, 7, 14, 30, and 90 days after RPD. Intra-arterial BP and HR were measured throughout RPD and after 14 days in 5 swine. RESULTS: During the procedure, RPD immediately reduced systolic BP (-20.6 ± 18.3 mm Hg), diastolic BP (-6.0 ± 8.3 mm Hg), and HR (-5.4 ± 5.6 bpm), which remained decreased at follow-up. The porcine kidneys had a mean NE reduction of 76% directly post procedure and 60% after 7 days, 64% after 14 days, 57% after 30 days, and 65% after 90 days. Histopathological examination confirmed nerve ablation. CONCLUSIONS: These preliminary findings suggest that the renal pelvis nerve ablation is an encouraging target for RDN. Clinical trials are required to test the feasibility of RPD in human hypertension.

"Back to the future: Beta radiation to treat recurrent in-stent restenosis".

When a patient presents with restenosis and two layers of previously place drug eluting stents this is a true treatment dilemma for the interventionist. Beta radiation has proven its efficacy to decrease in-stent restenosis compared to standard PCI. No drug-coated balloons are currently available in the United States for treatment of in-stent restenosis.

Belt and suspenders: Why it pays to protect and cover during carotid stenting.

Carotid stenting results show equivalence to carotid endarterectomy. Most patients undergoing carotid intervention are asymptomatic. Using embolic protection with a covered mesh stent shows promise in this first large multicenter study.

Lithotripsy for peripheral artery disease: Encouraging immediate results But show us the money!

Of adults, 12% have PAD, with nearly 30% older than 70 years with the disorder. With obesity, diabetes mellitus, tobacco abuse, hypercholesterolemia, and poorly controlled hypertension, the incidence of PAD continues to increase. Endovascular treatment of femoropopliteal disease has an alarmingly high rate of restenosis, even with new technology with target lesion revascularization rates at 40-60% at 1 year. Intravascular lithotripsy appears to be safe and acutely effective, but there is no long-term data on whether it has a role in effective treatment of PAD.

Covered stents: A 25-year odyssey.

The concept of the PTFE-covered stent was introduced 25 years ago in the treatment of an aneurysmal vein graft. The study by Pavani et al. represents the largest cohort of patients treated with covered stents for Ellis type 3 perforations. Covered stents are effective in treating coronary perforations and remain an invaluable tool in the cardiac catheterization lab.

PCI on a tear: Not all perforations need coverage.

Coronary perforations are a potentially lethal complication of PCI requiring prompt treatment. The study by Rosseel et al demonstrates no difference in 5-year outcomes in patients with large coronary perforations treated with and without covered stents. Covered stents are effective in treating coronary perforations and are invaluable in the cardiac catheterization lab.

Perforations and how to manage: The coronary interventionalist and peripheral interventionalist working together for a solution.

Perforations can occur in both peripheral and coronary interventional procedures potentially resulting in severe morbidity A readily available therapeutic option to treat perforations should be present in every cath lab that does coronary and peripheral procedures The use of a coagulated thrombus injection can be an effective treatment option, but if a major vessel is affected that must remain patent, one viable option is to administer the patients' own clotted blood to recanalize the vessel without permanent sequelae.

Which embolic protection device is ideal during carotid artery stenting?

Embolic stroke is one of the main risks of carotid artery stenting. The EMBOLDEN trial demonstrates the safety and efficacy of the Gore® embolic filter. There is no clear evidence for the benefit of one filter-type over another. It is important to choose the device with which the interventionalist has significant familiarity.

Is the S.M.A.R.T® stent the smart option to treat femoropopliteal disease?

The femoropopliteal (FP) artery is a common site for endovascular interventions. S.M.A.R.T.® stent is effective in treating FP lesions with results comparable to other treatment options. Without head-to-head randomized controlled trials, the ideal treatment strategy for FP lesions remains unknown.

Between a Rock and a Hard Place: Adventures in Treating Calcific Femoropopliteal Disease.

SFA disease has unique challenges A myriad of interventional techniques have been proposed to treat calcific femoral disease It appears a combination of atherectomy and drug elution may be the procedure of choice in these patients New innovative therapies may be a viable option in the future.

Make PCI great again: Come on USA, catch up with the rest of the world.

Same day discharge after PCI lags in the USA The radial approach to PCI reduces complications compared to the femoral approach USA physicians need to seize the opportunity to not only perform PCI safely, but with economic responsibility.

Evidence for polymicrobial communities in explanted vascular filters and atheroma debris.

RATIONALE: Microbial communities have been implicated in a variety of disease processes and have been intermittently observed in arterial disease; however, no comprehensive unbiased community analysis has been performed. We hypothesize that complex microbial communities may be involved in chronic vascular diseases as well and may be effectively characterized by molecular assays. OBJECTIVE: The main objective is to survey vascular debris, atheroma, and vascular filters for polymicrobial communities consisting of prokaryotic and eukaryotic microbes, specifically eukaryotic microbes. METHODS AND RESULTS: We examined vascular aspirates of atheromatous debris or embolic protection filters in addition to matched peripheral blood samples, from fifteen patients, as well as three cadaveric coronary arteries from two separate patients, for microbial communities. General fluorescence microscopy by Höechst and ethidium bromide DNA stains, prokaryotic and eukaryotic community analysis by Next Generation DNA Sequencing (NGS), and a eukaryotic microbial 9 probe multiplexed quantitative PCR were used to detect and characterize the presence of putative polymicrobial communities. No prokaryotes were detected in peripheral blood; however, in 4 of 9 sequenced filters and in 2 of 7 sequenced atheroma debris samples, prokaryotic populations were identified. By DNA sequencing, eukaryotic microbes were detected in 4 of 15 blood samples, 5 of the 9 sequenced filters, and 3 of the 7 atheroma debris samples. The quantitative multiplex PCR detected sequences consistent with eukaryotic microbes in all 9 analyzed filter samples as well as 5 of the 7 atheroma debris samples. Microscopy reveals putative polymicrobial communities within filters and atheroma debris. The main contributing prokaryotic species in atheroma debris suggest a diverse and novel composition. Additionally, Funneliformis mosseae, an arbuscular mycorrhizal fungus in the Glomeraceae family, was detected in the coronary hard plaque from two patients. Well studied biofilm forming bacteria were not detectable in circulating peripheral blood and were not universally present in atheroma or filters. Analyses of the sequenced eukaryotes are consistent with a diverse of array poorly studied environmental eukaryotes. In summary, out of 15 patients, 6 exhibited molecular evidence of prokaryotes and 14 had molecular evidence of eukaryotic and/or polymicrobial communities in vivo, while 2 post-mortem coronary plaque samples displayed evidence of fungi. CONCLUSION: Prokaryotes are not consistently observed in atheroma debris or filter samples; however, detection of protozoa and fungi in these samples suggests that they may play a role in arterial vascular disease or atheroma formation.

Stroke care: Room for improvement.

Endovascular devices to treat stroke will continue to improve Stroke care is suboptimal with IV TPA with such a narrow treatment window Interventional cardiologists should be involved in stroke care with appropriate training.

Back to nature: A more natural alternative to the PTFE covered stent: Twenty-two years in the making.

The introduction of easily deployed covered stents has made PCI safer. The homemade venous and PTFE covered stent were effective but not practical for sealing perforations. The novel pericardial covered stent graft goes back to a more natural covering and is more easily deployed.

ACS Treatment Continues to Improve: But Price Matters.

Over 90% of patients achieve adequate levels of platelet inhibition with both Prasugrel and Ticagrelor. The introduction of Prasugrel was met with some hesitation from physicians because of the significant increase in cost. This pharmaceutically sponsored and authored retrospective study suggests that both agents are effective.