James W. Choi M.D.

Tajti, P., D. Karmpaliotis, K. Alaswad, C. Toma, J. W. Choi, F. A. Jaffer, A. H. Doing, M. Patel, E. Mahmud, B. Uretsky, A. Karatasakis, J. Karacsonyi, B. A. Danek, B. V. Rangan, S. Banerjee, I. Ungi and E. S. Brilakis (2018). “Prevalence, Presentation and Treatment of ‘Balloon Undilatable’ Chronic Total Occlusions: Insights from a Multicenter US Registry.” Catheter Cardiovasc Interv. Jan 23. [Epub ahead of print].

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BACKGROUND: The prevalence, treatment and outcomes of balloon undilatable chronic total occlusions (CTOs) have received limited study. METHODS: We examined the prevalence, clinical and angiographic characteristics, and procedural outcomes of percutaneous coronary interventions (PCIs) for balloon undilatable CTOs in a contemporary multicenter US registry. RESULTS: Between 2012 and 2017 data on balloon undilatable lesions were available for 425 consecutive CTO PCIs in 415 patients in whom guidewire crossing was successful: 52 of 425 CTOs were balloon undilatable (12%). Mean patient age was 65 +/- 10 years and most patients were men (84%). Patients with balloon undilatable CTOs were more likely to be diabetic (67 vs. 41%, P < 0.001) and have heart failure (44 vs. 28%, P = 0.027). Balloon undilatable CTOs were longer (40 mm [interquartile range, IQR 20-50] vs. 30 [IQR 15-40], P = 0.016), more likely to have moderate/severe calcification (87 vs. 54%, P < 0.001), and had higher J-CTO score (3.2 +/- 1.1 vs. 2.5 +/- 1.3, P < 0.001) and PROGRESS-CTO complications score (3.9 +/- 1.7 vs. 3.1 +/- 2.0, P < 0.005). They were associated with lower technical and procedural success (92 vs. 98%, P = 0.024; and 88 vs. 96%, P = 0.034, respectively) and higher risk for in-hospital major adverse events (8 vs. 2%, P = 0.008) due to higher perforation rates. The most frequent treatments for balloon undilatable CTOs were high pressure balloon inflations (64%), rotational atherectomy (31%), laser (21%), and cutting balloons (15%). CONCLUSIONS: Balloon undilatable CTOs are common and are associated with lower success and higher complication rates. CLINICAL TRIAL REGISTRATION: NCT02061436, Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS CTO).

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.

Oguayo, K. N., C. C. Oguayo, R. Vallabhan and J. W. Choi (2017). “Microcatheter balloon pinning technique to facilitate wiring of a left circumflex chronic total occlusion.” Cardiovasc Ther 35(6): 2017 Nov [Epub ahead of print].

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INTRODUCTION: Coronary chronic total occlusions (CTOs) are commonly encountered during diagnostic angiograms. With recent advances, especially in experienced centers, success rates with CTO percutaneous coronary intervention (PCI) have approached 80% or higher. It is important to note that despite these advancements in techniques, CTOs remain difficult to treat. We present a case of a left circumflex artery (LCX) CTO that was successfully revascularized using a microcatheter balloon pinning technique that allowed additional wire support. CASE REPORT: A 77-year-old woman status post-two-vessel coronary artery bypass graft surgery presented with new onset angina at rest and was found to have a patent graft to the left anterior descending artery, and an unrevascularized proximal LCX CTO. PCI was attempted with a microcatheter using an antegrade approach. This approach was unsuccessful due to the lack of support and the left circumflex angle. As a result, we used a balloon to pin the microcatheter to the wall of the left main to allow for successful wiring of the LCX. A stent was successfully deployed in the LCX, and the patient was discharged from the hospital 2 days later. At follow-up, the patient was asymptomatic and returned to her usual activity. DISCUSSION: After conducting a thorough literature search, it appears that this is the first case that a microcatheter has been pinned with a balloon. We believe that in LCX CTOs that require support, the microcatheter pinning technique can provide adequate support in wiring CTO’s. LCX CTOs can be very difficult to treat, we present a case of a LCX CTO that required the use of the microcatheter balloon pinning technique to allow additional wire support for successful wiring and ultimately treatment.

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: 2017 Aug [Epub ahead of print].

Full text of this article.

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.