Baylor Heart and Vascular Institute

Parsa, P., J. Eidt, A. Rios, D. Gable and J. Vasquez, Jr. (2018). “Case Report: An Innovative Endovascular Technique for Repair of Descending Thoracic Aortic Aneurysm following an Open Coarctation Repair.” Ann Vasc Surg 46: 205.

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It was once postulated that open surgical repair of coarctation of the aorta during childhood patients was cured. However, long-term follow-up has been significant for late problems such as an aneurysm. The incidence of such aneurysm after open surgical coarctation repair is 11-24%. If such an aneurysm is left untreated, patients are at a high risk of morbidity and mortality. Prior to the endovascular era, patients would require a redo open repair which in itself is a highly morbid operation. Currently, thoracic endovascular aortic repair (TEVAR) has been reported as a feasible and safe alternative to open surgical reprocedures in this context. However, TEVAR might be challenging due to the proximity of the pathology to supraaortic vessels and the ongoing presence of the coarctation. We are reporting a unique case of a 48-year-old male undergoing TEVAR due to aortic aneurysm after previous surgical coarctation treatment and successful closure of the coarctation with a vascular plug device.

Feldman, T. E., M. J. Reardon, V. Rajagopal, R. R. Makkar, T. K. Bajwa, N. S. Kleiman, A. Linke, D. J. Kereiakes, R. Waksman, V. H. Thourani, R. C. Stoler, G. J. Mishkel, D. G. Rizik, V. S. Iyer, T. G. Gleason, D. Tchetche, J. D. Rovin, M. Buchbinder, I. T. Meredith, M. Gotberg, H. Bjursten, C. Meduri, M. H. Salinger, D. J. Allocco and K. D. Dawkins (2018). “Effect of Mechanically Expanded vs Self-Expanding Transcatheter Aortic Valve Replacement on Mortality and Major Adverse Clinical Events in High-Risk Patients With Aortic Stenosis: The REPRISE III Randomized Clinical Trial.” Jama 319(1): 27-37.

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Importance: Transcatheter aortic valve replacement (TAVR) is established for selected patients with severe aortic stenosis. However, limitations such as suboptimal deployment, conduction disturbances, and paravalvular leak occur. Objective: To evaluate if a mechanically expanded valve (MEV) is noninferior to an approved self-expanding valve (SEV) in high-risk patients with aortic stenosis undergoing TAVR. Design, Setting, and Participants: The REPRISE III trial was conducted in 912 patients with high or extreme risk and severe, symptomatic aortic stenosis at 55 centers in North America, Europe, and Australia between September 22, 2014, and December 24, 2015, with final follow-up on March 8, 2017. Interventions: Participants were randomized in a 2:1 ratio to receive either an MEV (n = 607) or an SEV (n = 305). Main Outcomes and Measures: The primary safety end point was the 30-day composite of all-cause mortality, stroke, life-threatening or major bleeding, stage 2/3 acute kidney injury, and major vascular complications tested for noninferiority (margin, 10.5%). The primary effectiveness end point was the 1-year composite of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak tested for noninferiority (margin, 9.5%). If noninferiority criteria were met, the secondary end point of 1-year moderate or greater paravalvular leak was tested for superiority in the full analysis data set. Results: Among 912 randomized patients (mean age, 82.8 [SD, 7.3] years; 463 [51%] women; predicted risk of mortality, 6.8%), 874 (96%) were evaluable at 1 year. The primary safety composite end point at 30 days occurred in 20.3% of MEV patients and 17.2% of SEV patients (difference, 3.1%; Farrington-Manning 97.5% CI, -infinity to 8.3%; P = .003 for noninferiority). At 1 year, the primary effectiveness composite end point occurred in 15.4% with the MEV and 25.5% with the SEV (difference, -10.1%; Farrington-Manning 97.5% CI, -infinity to -4.4%; P<.001 for noninferiority). The 1-year rates of moderate or severe paravalvular leak were 0.9% for the MEV and 6.8% for the SEV (difference, -6.1%; 95% CI, -9.6% to -2.6%; P < .001). The superiority analysis for primary effectiveness was statistically significant (difference, -10.2%; 95% CI, -16.3% to -4.0%; P < .001). The MEV had higher rates of new pacemaker implants (35.5% vs 19.6%; P < .001) and valve thrombosis (1.5% vs 0%) but lower rates of repeat procedures (0.2% vs 2.0%), valve-in-valve deployments (0% vs 3.7%), and valve malpositioning (0% vs 2.7%). Conclusions and Relevance: Among high-risk patients with aortic stenosis, use of the MEV compared with the SEV did not result in inferior outcomes for the primary safety end point or the primary effectiveness end point. These findings suggest that the MEV may be a useful addition for TAVR in high-risk patients.

Bangalore, S., H. G. Bezerra, D. G. Rizik, E. J. Armstrong, B. Samuels, S. S. Naidu, C. L. Grines, M. T. Foster, J. W. Choi, B. D. Bertolet, A. P. Shah, R. Torguson, S. B. Avula, J. C. Wang, J. P. Zidar, A. Maksoud, A. Kalyanasundaram, S. J. Yakubov, B. M. Chehab, A. J. Spaedy, S. P. Potluri, R. P. Caputo, A. Kondur, R. F. Merritt, A. Kaki, R. Quesada, M. A. Parikh, C. Toma, F. Matar, J. DeGregorio, W. Nicholson, W. Batchelor, R. Gollapudi, E. Korngold, R. Sumar, G. S. Chrysant, J. Li, J. B. Gordon, R. M. Dave, G. F. Attizzani, T. P. Stys, O. S. Gigliotti, B. E. Murphy, S. G. Ellis and R. Waksman (2017). “The State of the Absorb Bioresorbable Scaffold: Consensus From an Expert Panel.” JACC Cardiovasc Interv 10(23): 2349-2359.

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Significant progress has been made in the percutaneous coronary intervention technique from the days of balloon angioplasty to modern-day metallic drug-eluting stents (DES). Although metallic stents solve a temporary problem of acute recoil following balloon angioplasty, they leave behind a permanent problem implicated in very late events (in addition to neoatherosclerosis). BRS were developed as a potential solution to this permanent problem, but the promise of these devices has been tempered by clinical trials showing increased risk of safety outcomes, both early and late. This is not too dissimilar to the challenges seen with first-generation DES in which refinement of deployment technique, prolongation of dual antiplatelet therapy, and technical iteration mitigated excess risk of very late stent thrombosis, making DES the treatment of choice for coronary artery disease. This white paper discusses the factors potentially implicated in the excess risks, including the scaffold consideration and deployment technique, and outlines patient and lesion selection, implantation technique, and dual antiplatelet therapy considerations to potentially mitigate this excess risk with the first-generation thick strut Absorb scaffold (Abbott Vascular, Abbott Park, Illinois). It remains to be seen whether these considerations together with technical iterations will ultimately close the gap between scaffolds and metal stents for short-term events while at the same time preserving options for future revascularization once the scaffold bioresorbs.

Townsend, R. R., F. Mahfoud, D. E. Kandzari, K. Kario, S. Pocock, M. A. Weber, S. Ewen, K. Tsioufis, D. Tousoulis, A. S. P. Sharp, A. F. Watkinson, R. E. Schmieder, A. Schmid, J. W. Choi, C. East, A. Walton, I. Hopper, D. L. Cohen, R. Wilensky, D. P. Lee, A. Ma, C. M. Devireddy, J. P. Lea, P. C. Lurz, K. Fengler, J. Davies, N. Chapman, S. A. Cohen, V. DeBruin, M. Fahy, D. E. Jones, M. Rothman and M. Bohm (2017). “Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (spyral htn-off med): A randomised, sham-controlled, proof-of-concept trial.” Lancet 390(10108): 2160-2170.

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BACKGROUND: Previous randomised renal denervation studies did not show consistent efficacy in reducing blood pressure. The objective of our study was to evaluate the effect of renal denervation on blood pressure in the absence of antihypertensive medications. METHODS: SPYRAL HTN-OFF MED was a multicentre, international, single-blind, randomised, sham-controlled, proof-of-concept trial. Patients were enrolled at 21 centres in the USA, Europe, Japan, and Australia. Eligible patients were drug-naive or discontinued their antihypertensive medications. Patients with an office systolic blood pressure (SBP) of 150 mm Hg or greater and less than 180 mm Hg, office diastolic blood pressure (DBP) of 90 mm Hg or greater, and a mean 24-h ambulatory SBP of 140 mm Hg or greater and less than 170 mm Hg at second screening underwent renal angiography and were randomly assigned to renal denervation or sham control. Patients, caregivers, and those assessing blood pressure were blinded to randomisation assignments. The primary endpoint, change in 24-h blood pressure at 3 months, was compared between groups. Drug surveillance was done to ensure patient compliance with absence of antihypertensive medication. The primary analysis was done in the intention-to-treat population. Safety events were assessed at 3 months. This study is registered with ClinicalTrials.gov, number NCT02439749. FINDINGS: Between June 25, 2015, and Jan 30, 2017, 353 patients were screened. 80 patients were randomly assigned to renal denervation (n=38) or sham control (n=42) and followed up for 3 months. Office and 24-h ambulatory blood pressure decreased significantly from baseline to 3 months in the renal denervation group: 24-h SBP -5.5 mm Hg (95% CI -9.1 to -2.0; p=0.0031), 24-h DBP -4.8 mm Hg (-7.0 to -2.6; p<0.0001), office SBP -10.0 mm Hg (-15.1 to -4.9; p=0.0004), and office DBP -5.3 mm Hg (-7.8 to -2.7; p=0.0002). No significant changes were seen in the sham-control group: 24-h SBP -0.5 mm Hg (95% CI -3.9 to 2.9; p=0.7644), 24-h DBP -0.4 mm Hg (-2.2 to 1.4; p=0.6448), office SBP -2.3 mm Hg (-6.1 to 1.6; p=0.2381), and office DBP -0.3 mm Hg (-2.9 to 2.2; p=0.8052). The mean difference between the groups favoured renal denervation for 3-month change in both office and 24-h blood pressure from baseline: 24-h SBP -5.0 mm Hg (95% CI -9.9 to -0.2; p=0.0414), 24-h DBP -4.4 mm Hg (-7.2 to -1.6; p=0.0024), office SBP -7.7 mm Hg (-14.0 to -1.5; p=0.0155), and office DBP -4.9 mm Hg (-8.5 to -1.4; p=0.0077). Baseline-adjusted analyses showed similar findings. There were no major adverse events in either group. INTERPRETATION: Results from SPYRAL HTN-OFF MED provide biological proof of principle for the blood-pressure-lowering efficacy of renal denervation.

Packer, M. (2017). “The imminent demise of cardiovascular drug development.” JAMA Cardiol: 2017 Nov [Epub ahead of print].

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The development of new cardiovascular drugs is at its deepest nadir in decades.¹ Major pharmaceutical companies have ended research activities in cardiology,² and applications to and approvals by the US Food and Drug Administration for new cardiovascular pharmaceuticals have declined dramatically even as innovations in other therapeutic areas have soared.