Cardiology

Cullen, M. W., R. B. McCully, R. J. Widmer, D. R. Schroeder, B. R. Salonen, D. Raslau, K. K. Sundsted, A. B. Mohabbat, B. M. Dougan, D. M. Bierle, A. Widmer, D. Banerjee, P. Gaba, R. Tellez, G. C. Kane, P. A. Pellikka and K. F. Mauck (2020). “Preoperative Dobutamine Stress Echocardiography and Clinical Factors for Assessment of Cardiac Risk after Noncardiac Surgery.” J Am Soc Echocardiogr 33(4): 423-432.

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BACKGROUND: The role of dobutamine stress echocardiography (DSE) in the risk stratification of patients undergoing noncardiac surgery in the current era is unclear. The aim of this study was to evaluate the yield of DSE and the additive role of DSE to clinical criteria for preoperative risk stratification of patients undergoing noncardiac surgery. METHODS: The study included 4,494 patients undergoing DSE /=3 had an event rate of 7.5%. The event rates for patients with wall motion score index >/=1.7 at baseline, left ventricular ejection fractions <40% at peak stress, or ischemic thresholds <70% of age-predicted maximal heart rate were 7.1%, 8.6%, and 7.9%, respectively. After adjusting for clinical variables, the overall result of DSE (P < .001), baseline and peak-stress wall motion score index (P < .001 and P = .014, respectively), peak-stress left ventricular ejection fraction (P < .001), and the number of ischemic segments (P = .027) were all associated with postoperative cardiac events. Incremental multivariate analysis demonstrated that an overall abnormal result on DSE, added to clinical variables, was associated with an increased risk for postoperative cardiac events (odds ratio, 2.07; 95% CI, 1.35-3.17; P < .001). CONCLUSIONS: Baseline and peak-stress findings on preoperative DSE add to the prognostic utility of clinical variables for stratifying cardiac risk after noncardiac surgery.

Bohm, M., K. Kario, D. E. Kandzari, F. Mahfoud, M. A. Weber, R. E. Schmieder, K. Tsioufis, S. Pocock, D. Konstantinidis, J. W. Choi, C. East, D. P. Lee, A. Ma, S. Ewen, D. L. Cohen, R. Wilensky, C. M. Devireddy, J. Lea, A. Schmid, J. Weil, T. Agdirlioglu, D. Reedus, B. K. Jefferson, D. Reyes, R. D’Souza, A. S. P. Sharp, F. Sharif, M. Fahy, V. DeBruin, S. A. Cohen, S. Brar and R. R. Townsend (2020). “Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial.” Lancet Mar 27. pii: S0140-6736(20)30554-7. [Epub ahead of print].

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BACKGROUND: Catheter-based renal denervation has significantly reduced blood pressure in previous studies. Following a positive pilot trial, the SPYRAL HTN-OFF MED (SPYRAL Pivotal) trial was designed to assess the efficacy of renal denervation in the absence of antihypertensive medications. METHODS: In this international, prospective, single-blinded, sham-controlled trial, done at 44 study sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK, and the USA, hypertensive patients with office systolic blood pressure of 150 mm Hg to less than 180 mm Hg were randomly assigned 1:1 to either a renal denervation or sham procedure. The primary efficacy endpoint was baseline-adjusted change in 24-h systolic blood pressure and the secondary efficacy endpoint was baseline-adjusted change in office systolic blood pressure from baseline to 3 months after the procedure. We used a Bayesian design with an informative prior, so the primary analysis combines evidence from the pilot and Pivotal trials. The primary efficacy and safety analyses were done in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT02439749. FINDINGS: From June 25, 2015, to Oct 15, 2019, 331 patients were randomly assigned to either renal denervation (n=166) or a sham procedure (n=165). The primary and secondary efficacy endpoints were met, with posterior probability of superiority more than 0.999 for both. The treatment difference between the two groups for 24-h systolic blood pressure was -3.9 mm Hg (Bayesian 95% credible interval -6.2 to -1.6) and for office systolic blood pressure the difference was -6.5 mm Hg (-9.6 to -3.5). No major device-related or procedural-related safety events occurred up to 3 months. INTERPRETATION: SPYRAL Pivotal showed the superiority of catheter-based renal denervation compared with a sham procedure to safely lower blood pressure in the absence of antihypertensive medications. FUNDING: Medtronic.

Makkar, R. R., V. H. Thourani, M. J. Mack, S. K. Kodali, S. Kapadia, J. G. Webb, S. H. Yoon, A. Trento, L. G. Svensson, H. C. Herrmann, W. Y. Szeto, D. C. Miller, L. Satler, D. J. Cohen, T. M. Dewey, V. Babaliaros, M. R. Williams, D. J. Kereiakes, A. Zajarias, K. L. Greason, B. K. Whisenant, R. W. Hodson, D. L. Brown, W. F. Fearon, M. J. Russo, P. Pibarot, R. T. Hahn, W. A. Jaber, E. Rogers, K. Xu, J. Wheeler, M. C. Alu, C. R. Smith and M. B. Leon (2020). “Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement.” New England Journal of Medicine 382(9): 799-809.

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BACKGROUND: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk. METHODS: We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke. RESULTS: At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery. CONCLUSIONS: Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).

Xenogiannis, I., F. Gkargkoulas, D. Karmpaliotis, O. Krestyaninov, D. Khelimskii, F. A. Jaffer, J. J. Khatri, D. E. Kandzari, R. M. Wyman, A. H. Doing, P. Dattilo, C. Toma, R. W. Yeh, H. Tamez, J. W. Choi, W. Jaber, H. Samady, A. M. Sheikh, S. Potluri, M. Patel, E. Mahmud, B. Elbaruni, M. P. Love, M. Koutouzis, I. Tsiafoutis, B. K. Jefferson, T. Patel, B. Uretsky, J. W. Moses, N. J. Lembo, M. Parikh, A. J. Kirtane, Z. A. Ali, A. B. Hall, M. S. Megaly, E. Vemmou, I. Nikolakopoulos, B. V. Rangan, P. W. Morley, B. Bou Dargham, S. Abdullah, S. Garcia, S. Banerjee, M. N. Burke, E. S. Brilakis and K. Alaswad (2020). “Retrograde Chronic Total Occlusion Percutaneous Coronary Intervention via Saphenous Vein Graft.” JACC Cardiovasc Interv 13(4): 517-526.

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OBJECTIVES: The aim of this study was to examine the use of saphenous vein grafts (SVGs) for retrograde crossing during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: The use of SVGs for retrograde crossing during CTO PCI has received limited study. METHODS: A total of 1,615 retrograde CTO PCIs performed between 2012 and 2019 at 25 centers were examined. Clinical, angiographic, and technical characteristics and procedural outcomes were compared among retrograde cases via SVGs (SVG group) versus other collateral vessels (non-SVG group). RESULTS: Retrograde CTO PCI via SVGs was performed in 189 cases (12%). Patients in the SVG group were older (mean age 70 +/- 9 years vs. 64 +/- 10 years; p < 0.01) and had higher rates of prior myocardial infarction (62% vs. 51%; p < 0.01) and prior PCI (81% vs. 70%; p < 0.01). They were more likely to have moderate or severe calcification (81% vs. 65%; p < 0.01) and moderate or severe tortuosity (53% vs. 44%; p = 0.02) and had similar J-CTO (Multicenter CTO Registry in Japan) scores (3.2 +/- 1.0 vs. 3.1 +/- 1.1; p = 0.13) but higher PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) scores (4.7 +/- 1.7 vs. 3.1 +/- 1.1; p < 0.01). Technical (85% vs. 78%; p = 0.04) and procedural (81% vs. 74%; p = 0.04) success rates were higher in the SVG group, with no difference in in-hospital major adverse events (6.4% vs. 4.4%; p = 0.22). Contrast volume was lower in the SVG group (225 ml [173 to 325 ml] vs. 292 ml [202 to 400 ml]; p < 0.01). CONCLUSIONS: Use of SVGs for retrograde crossing is associated with higher rates of technical and procedural success and similar rates of in-hospital major adverse cardiac events compared with retrograde CTO PCI via other collateral vessels.

Xenogiannis, I., F. Gkargkoulas, D. Karmpaliotis, K. Alaswad, O. Krestyaninov, D. Khelimskii, J. W. Choi, F. A. Jaffer, M. Patel, E. Mahmud, J. J. Khatri, D. E. Kandzari, A. H. Doing, P. Dattilo, C. Toma, M. Koutouzis, I. Tsiafoutis, B. Uretsky, R. W. Yeh, H. Tamez, R. M. Wyman, B. K. Jefferson, T. Patel, W. Jaber, H. Samady, A. M. Sheikh, B. A. Malik, E. Holper, S. Potluri, J. W. Moses, N. J. Lembo, M. Parikh, A. J. Kirtane, Z. A. Ali, A. B. Hall, E. Vemmou, I. Nikolakopoulos, B. B. Dargham, B. V. Rangan, S. Abdullah, S. Garcia, S. Banerjee, M. N. Burke and E. S. Brilakis (2020). “The Impact of Peripheral Artery Disease in Chronic Total Occlusion Percutaneous Coronary Intervention (Insights From PROGRESS-CTO Registry).” Angiology 71(3): 274-280.

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The impact of peripheral artery disease (PAD) in patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. We reviewed 3999 CTO PCIs performed in 3914 patients between 2012 and 2018 at 25 centers, 14% of whom had a history of PAD. We compared the clinical and angiographic characteristics and procedural outcomes of patients with versus without history of PAD. Patients with PAD were older (67 +/- 9 vs 64 +/- 10 years, P < .001) and had a higher prevalence of cardiovascular risk factors. They also had more complex lesions as illustrated by higher Japanese CTO score (2.7 +/- 1.2 vs 2.4 +/- 1.3, P < .001). In patients with PAD, the final crossing technique was less often antegrade wire escalation (40% vs 51%, P < .001) and more often the retrograde approach (23 vs 20%, P < .001) and antegrade dissection/reentry (20% vs 16%, P < .001). Technical success was similar between the 2 study groups (84% vs 87%, P = .127), but procedural success was lower for patients with PAD (81% vs 85%, P = .015). The incidence of in-hospital major adverse cardiac events was higher among patients with PAD (3% vs 2%, P = .046). In conclusion, patients with PAD undergoing CTO PCI have more comorbidities, more complex lesions, and lower procedural success.