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143


Suprasternal Aortic Valve Replacement: Key Technology and Techniques

Kiser, Andy C; Caranasos, Thomas G; Peterson, Mark D; Buller, Christopher E; Borger, Michael A
PURPOSE/OBJECTIVE:Suprasternal transcatheter aortic valve replacement offers patients, with unsuitable femoral artery anatomy, an alternative to transapical, direct aortic, and subclavian approaches. DESCRIPTION/METHODS:The Transit System (Aegis Surgical, Galway, Ireland) enables transcatheter aortic valve replacement directly into the ascending aorta or innominate artery through a small, suprasternal incision. The valve introducer sheath is inserted through a standard pursestring suture, which facilitates secure arterial closure. The proximity to the aortic valve promotes precise control. EVALUATION/RESULTS:Proper patient selection and preoperative imaging is essential. A heart team working collaboratively in a hybrid operating room ensures procedural success. Using this approach, four different manufacturer's transcatheter valves have been used successfully. CONCLUSIONS:Suprasternal transcatheter aortic valve replacement is a safe and effective addition to the surgeon's armamentarium.
PMID: 28935306
ISSN: 1552-6259
CID: 5450152

Clinical outcomes after trans-catheter aortic valve replacement in men and women in Ontario, Canada

Czarnecki, Andrew; Qiu, Feng; Koh, Maria; Prasad, Treesa J; Cantor, Warren J; Cheema, Asim N; Chu, Michael W A; Feindel, Christopher; Fremes, Stephen E; Kingsbury, Kori; Natarajan, Madhu K; Peterson, Mark D; Ruel, Marc; Strauss, Bradley H; Wijeysundera, Harindra C; Ko, Dennis T
OBJECTIVE:Our objective was to evaluate sex-differences in outcomes after trans-catheter aortic valve replacement (TAVR) in a population-based cohort from Ontario, Canada. BACKGROUND:Prior studies comparing outcomes in men and women after TAVR have yielded divergent results. Some studies have suggested that women have better survival than men while others have not corroborated this finding. METHODS:A retrospective observational cohort study was conducted using chart abstraction data on all TAVR procedures performed between 2007 and 2013 in Ontario, Canada. Patients who had emergency TAVR procedures were excluded. The primary outcome was all-cause mortality at 30-days and 1-year. Secondary outcomes included mortality at last follow-up, cause-specific, and all-cause hospital readmission. Inverse probability of treatment weighting (IPTW) using propensity score was used to adjust for baseline differences between men and women. RESULTS:The final study cohort consisted of 453 women and 546 men with a mean follow-up of 3.5 years. Women were generally older and more frail but had less comorbid conditions. Women had lower unadjusted mean EuroScores (7% ± 5% vs 8% ± 7%; P = 0.008), but underwent significantly more trans-apical procedures (26.5% vs 19.2%; P = 0.006) than men. After IPTW, the groups were well balanced. Although mortality was numerically higher for women at 30-days (7.2% vs 5.4%), this was not statistically significant (P = 0.34). At 1-year, there was no difference in mortality (18.2% vs 19.2%; P = 0.85). There were no significant differences in all-cause readmission. CONCLUSION/CONCLUSIONS:In this population-based cohort including all patients undergoing TAVR, mortality or all-cause readmission were not significantly different between men and women. © 2017 Wiley Periodicals, Inc.
PMID: 28145088
ISSN: 1522-726x
CID: 5450072

From sutures to wires: The evolving necessities of cardiac surgery training [Editorial]

Pelletier, Marc P; Kaneko, Tsuyoshi; Peterson, Mark D; Thourani, Vinod H
PMID: 28645829
ISSN: 1097-685x
CID: 5450102

2-Year Outcomes After Transcatheter Mitral Valve Replacement

Regueiro, Ander; Ye, Jian; Fam, Neil; Bapat, Vinayak N; Dagenais, François; Peterson, Mark D; Windecker, Stephan; Webb, John G; Rodés-Cabau, Josep
OBJECTIVES:This study sought to determine late (2-year) outcomes following transcatheter mitral valve replacement (TMVR) with the FORTIS valve (Edwards Lifesciences, Irvine, California). BACKGROUND:No data exist on long-term clinical outcomes following TMVR in patients with severe native mitral regurgitation (MR). METHODS:This multicenter registry included consecutive patients with severe MR who underwent TMVR with the FORTIS valve under a compassionate clinical use program. Clinical and echocardiographic data were collected at baseline, 30-day, and 1- and 2-year follow-up. RESULTS:Thirteen patients (71 ± 8 years, 10 men, logistic European System for Cardiac Operative Risk Evaluation score = 23.7 ± 12.1%) with severe MR were included. MR was of ischemic origin in most (76.9%) patients, and the mean left ventricular ejection fraction was 34 ± 9%. Technical success was achieved in 10 patients (76.9%), and 5 patients (38.5%) died within the 30 days following the procedure. At 30-day follow-up, mean transmitral gradient was 3 ± 1 mm Hg, and there were no cases of moderate-severe residual MR or left ventricular outflow tract obstruction. Two patients died during the follow-up period due to terminal heart failure, leading to an all-cause mortality rate of 54% at 2-year follow-up. At 2-year follow-up, all patients but 1 were in New York Heart Association functional class II, and there were no cases of valve malfunction (increasing gradients or MR recurrence). Computed tomography exams performed at 2-year follow-up in 3 patients showed no valve prosthesis fractures or displacement. CONCLUSIONS:TMVR with the FORTIS valve was feasible. MR reduction after TMVR was maintained at 2-year follow-up and no late device-related events were observed.
PMID: 28838478
ISSN: 1876-7605
CID: 5450142

Frailty in Older Adults Undergoing Aortic Valve Replacement: The FRAILTY-AVR Study

Afilalo, Jonathan; Lauck, Sandra; Kim, Dae H; Lefèvre, Thierry; Piazza, Nicolo; Lachapelle, Kevin; Martucci, Giuseppe; Lamy, Andre; Labinaz, Marino; Peterson, Mark D; Arora, Rakesh C; Noiseux, Nicolas; Rassi, Andrew; Palacios, Igor F; Généreux, Philippe; Lindman, Brian R; Asgar, Anita W; Kim, Caroline A; Trnkus, Amanda; Morais, José A; Langlois, Yves; Rudski, Lawrence G; Morin, Jean-Francois; Popma, Jeffrey J; Webb, John G; Perrault, Louis P
BACKGROUND:Frailty is a geriatric syndrome that diminishes the potential for functional recovery after a transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) procedure; however, its integration in clinical practice has been limited by a lack of consensus on how to measure it. OBJECTIVES/OBJECTIVE:This study sought to compare the incremental predictive value of 7 different frailty scales to predict poor outcomes following TAVR or SAVR. METHODS:A prospective cohort of older adults undergoing TAVR or SAVR was assembled at 14 centers in 3 countries from 2012 to 2016. The following frailty scales were compared: Fried, Fried+, Rockwood, Short Physical Performance Battery, Bern, Columbia, and the Essential Frailty Toolset (EFT). Outcomes of interest were all-cause mortality and disability 1 year after the procedure. RESULTS:The cohort was composed of 1,020 patients with a median age of 82 years. Depending on the scale used, the prevalence of frailty ranged from 26% to 68%. Frailty as measured by the EFT was the strongest predictor of death at 1 year (adjusted odds ratio [OR]: 3.72; 95% confidence interval [CI]: 2.54 to 5.45) with a C-statistic improvement of 0.071 (p < 0.001) and integrated discrimination improvement of 0.067 (p < 0.001). Moreover, the EFT was the strongest predictor of worsening disability at 1 year (adjusted OR: 2.13; 95% CI: 1.57 to 2.87) and death at 30 days (adjusted OR: 3.29; 95% CI: 1.73 to 6.26). CONCLUSIONS:Frailty is a risk factor for death and disability following TAVR and SAVR. A brief 4-item scale encompassing lower-extremity weakness, cognitive impairment, anemia, and hypoalbuminemia outperformed other frailty scales and is recommended for use in this setting. (Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions; NCT01845207).
PMID: 28693934
ISSN: 1558-3597
CID: 5450112

Early Outcomes of Acute Retrograde Dissection From the International Registry of Acute Aortic Dissection

Nauta, Foeke J H; Kim, Joon Bum; Patel, Himanshu J; Peterson, Mark D; Eckstein, Hans-Henning; Khoynezhad, Ali; Ehrlich, Marek P; Eusanio, Marco Di; Corte, Alessandro Della; Montgomery, Daniel G; Nienaber, Christoph A; Isselbacher, Eric M; Eagle, Kim A; Sundt, Thoralf M; Trimarchi, Santi
To provide data on the management and outcomes of patients with acute retrograde aortic dissection (AD) originating from a tear in the descending aorta with extension into the aortic arch or ascending aorta. All patients enrolled in the International Registry of Acute Aortic Dissection from 1996-2015 were reviewed. Retrograde AD was defined by primary tear in the descending aorta with proximal extension into the arch or ascending aorta. Primary end points were in-hospital management strategy and mortality. We identified 101 patients with retrograde AD (67 men; 63.2 ± 14.0 years). During index hospitalization, medical (MED), open surgical (SURG), and endovascular (ENDO) therapies were undertaken in 44, 33, and 22 patients, respectively. The SURG group presented with larger ascending aorta (P = 0.04) and more frequent ascending aortic involvement (81.8% [27/33] vs 22.7% [15/66], P < 0.001) compared with the MED and ENDO groups. Early mortality rate was 9.1% (4/44), 18.2% (6/33), and 13.6% (3/22), for the MED, SURG, and ENDO groups (P = 0.51), respectively. A favorable early mortality rate was observed in patients with retrograde extension limited to the arch (8.6% [5/58]) vs into the ascending aorta (18.6% [8/43], P = 0.14). Early mortality rate of patients with retrograde AD with primary tear in the descending aorta (12.9% [13/101]) was significantly lower than those with classic type A AD presenting with primary tear in the ascending aorta (20.0% [195/977], P = 0.001). A subset of patients with acute retrograde AD originating from primary tear in the descending aorta might be managed less invasively with acceptable early results, particularly among those with proximal extension limited to the arch.
PMID: 28823321
ISSN: 1532-9488
CID: 5450132

Axillary versus innominate artery cannulation for antegrade cerebral perfusion in aortic surgery: design of the Aortic Surgery Cerebral Protection Evaluation (ACE) CardioLink-3 randomised trial

Garg, Vinay; Peterson, Mark D; Chu, Michael Wa; Ouzounian, Maral; MacArthur, Roderick Gg; Bozinovski, John; El-Hamamsy, Ismail; Victor Chu, F; Garg, Ankit; Hall, Judith; Thorpe, Kevin E; Dhingra, Natasha; Teoh, Hwee; Marotta, Thomas R; Latter, David A; Quan, Adrian; Mamdani, Muhammad; Juni, Peter; David Mazer, C; Verma, Subodh
INTRODUCTION:Neurological injury remains the major cause of morbidity and mortality following open aortic arch repair. Systemic hypothermia along with antegrade cerebral perfusion (ACP) is the accepted cerebral protection approach, with axillary artery cannulation being the most common technique used to establish ACP. More recently, innominate artery cannulation has been shown to be a safe and efficacious method for establishing ACP. Inasmuch as there is a lack of high-quality data comparing axillary and innominate artery ACP, we have designed a randomised, multi-centre clinical trial to compare both cerebral perfusion strategies with regards to brain morphological injury using diffusion-weighted MRI (DW-MRI). METHODS AND ANALYSIS:110 patients undergoing elective aortic surgery with repair of the proximal arch requiring an open distal anastamosis will be randomised to either the innominate artery or the axillary artery cannulation strategy for establishing unilateral ACP during systemic circulatory arrest with moderate levels of hypothermia. The primary safety endpoint of this trial is the proportion of patients with new radiologically significant ischaemic lesions found on postoperative DW-MRI compared with preoperative DW-MRI. The primary efficacy endpoint of this trial is the difference in total operative time between the innominate artery and the axillary artery cannulation group. ETHICS AND DISSEMINATION:The study protocol and consent forms have been approved by the participating local research ethics boards. Publication of the study results is anticipated in 2018 or 2019. If this study shows that the innominate artery cannulation technique is non-inferior to the axillary artery cannulation technique with regards to brain morphological injury, it will establish the innominate artery cannulation technique as a safe and potentially more efficient method of antegrade cerebral perfusion in aortic surgery. TRIAL REGISTRATION NUMBER:NCT02554032.
PMCID:5623414
PMID: 28601820
ISSN: 2044-6055
CID: 5450832

Comparison of Outcomes of Balloon-Expandable Versus Self-Expandable Transcatheter Heart Valves for Severe Aortic Stenosis

Wijeysundera, Harindra C; Qiu, Feng; Koh, Maria; Prasad, Treesa J; Cantor, Warren J; Cheema, Asim; Chu, Michael W A; Czarnecki, Andrew; Feindel, Christopher; Fremes, Stephen E; Kingsbury, Kori J; Natarajan, Madhu K; Peterson, Mark; Ruel, Marc; Strauss, Bradley; Ko, Dennis T
Transcatheter aortic valve implantation (TAVI) is the treatment of choice for inoperable and high-risk patients with severe aortic stenosis. Our objectives were to elucidate potential differences in clinical outcomes and safety between balloon-expandable versus self-expandable transcatheter heart valves (THV). We performed a retrospective cohort study of all transfemoral TAVI procedures in Ontario, Canada, from 2007 to 2013. Patients were categorized into either balloon-expandable or self-expandable THV groups. The primary outcomes were 30-day and 1-year death, with secondary outcomes of all-cause readmission. Safety outcomes included bleeding, permanent pacemaker implantation, need for a second THV device, postprocedural paravalvular aortic regurgitation, stroke, vascular access complication, and intensive care unit length of stay. Inverse probability of treatment-weighted regression analyses using a propensity score were used to account for differences in baseline confounders. Our cohort consisted of 714 patients, of whom 397 received a self-expandable THV, whereas 317 had a balloon-expandable THV system. There were no differences in death or all-cause readmission. In terms of safety, the self-expandable group was associated with significantly higher rates of inhospital stroke (p value <0.05), need for a second THV device (5.3% vs 2.7%; p value = 0.013), and permanent pacemaker (22.6% vs 8.9%; p value <0.001), whereas the balloon-expandable group had more vascular access site complications (23.1% vs 16.7%; p value = 0.002). Thus, we found similar clinical outcomes of death or readmission for patients who underwent transfemoral TAVI with either balloon-expandable or self-expandable THV systems. However, there were important differences in their safety profiles.
PMID: 28153349
ISSN: 1879-1913
CID: 5450082

Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease

Stone, Gregg W; Sabik, Joseph F; Serruys, Patrick W; Simonton, Charles A; Généreux, Philippe; Puskas, John; Kandzari, David E; Morice, Marie-Claude; Lembo, Nicholas; Brown, W Morris; Taggart, David P; Banning, Adrian; Merkely, Béla; Horkay, Ferenc; Boonstra, Piet W; van Boven, Ad J; Ungi, Imre; Bogáts, Gabor; Mansour, Samer; Noiseux, Nicolas; Sabaté, Manel; Pomar, José; Hickey, Mark; Gershlick, Anthony; Buszman, Pawel; Bochenek, Andrzej; Schampaert, Erick; Pagé, Pierre; Dressler, Ovidiu; Kosmidou, Ioanna; Mehran, Roxana; Pocock, Stuart J; Kappetein, A Pieter; van Es, Gerrit-Anne; Leon, Martin B; Gersh, Bernard; Chaturvedi, Seemant; Kint, Peter-Paul; Valgimigli, Marco; Colombo, Antonio; Costa, Marco; Di Mario, Carlo; Ellis, Stephen; Fajadet, Jean; Fearon, William; Kereiakes, Dean; Makkar, Raj; Mintz, Gary S; Moses, Jeffrey W; Teirstein, Paul; Ruel, Marc; Sergeant, Paul; Mack, Michael; Fontana, Greg; Mohr, Frederick-Wilhelm; Nataf, Patrick; Smith, Craig; Boden, Bill; Fox, Keith; Maron, David; Steg, Gabriel; Blackstone, Eugene; Juni, Peter; Parise, Helen; Wallentin, Lars; Bertrand, Michel; Krucoff, Mitchell; Turina, Marko; Ståhle, Elisabeth; Tijssen, Jan; Brill, David; Atkins, Cary; Applegate, Bob; Argenziano, Michael; Faly, Richard C; Dauerman, Harold; Davidson, Charles; Griffith, Bartley; Reisman, Mark; Rizik, David; Sakwa, Marc; Shemin, Richard; Romano, Mauro; Hamm, Christian; Gummert, Jan; Tamburino, Corrado; Alfieri, Ottavio; Savina, C; de Bruyne, Bernard; Machado, Francisco Pereira; Uva, Souza; Moccetti, Tiziano; Siclari, Francesco; Hildick-Smith, David; Szekely, Laszlo; Erglis, Andrejs; Stradins, Peteris; Abizaid, Alex; Bento Sousa, Luis Carlos; Belardi, Jorge; Navia, Daniel; Park, S J; Lee, Jay-Wo; Meredith, Ian; Smith, Julian; Yehuda, Ori-Ben; Schneijdenberg, Rob; Ronden, Jacintha; Jonk, Judith; Jonkman, Anja; van Remortel, Eric; de Zwart, Ingrid; Elshout, Liliane; de Vries, Ton; Andreae, Rick; Tol van, Judith; Teurlings, Eva; Balachandran, Saranya; Breazna, Aurora; Jenkins, Paul; McAndrew, Tom; Marx, Steven O; Connolly, Mark W; Hong, Mun K; Weinberger, Jesse; Wong, Shing Chiu; Dizon, Joe; Biviano, Angelo; Morrow, John; Wang, Daniel; Corral, Maria; Alfonso, Maria; Sanchez, Raquel; Wright, Douey; Djurkovic, Champika; Lustre, Mitchel; Jankovic, Ivana; Sanidas, Elias; LaSalle, Laura; Maehara, Akiko; Matsumura, Mitsuaki; Sun, Eric; Iacono, Stephen; Greenberg, Tess; Jacobson, Jaclyn; Pullano, Anthony; Gacki, Marek; Liu, Shen; Cohen, David J; Magnuson, Elizabeth; Baron, Suzanne J; Wang, Kaijun; Traylor, Kendra; Worthley, Stephen; Stuklis, Robert; Barbato, Emanuele; Stockman, Bernard; Dubois, Christophe; Meuris, Bart; Vrolix, Mathias; Dion, Robert; Abizaid, Alexandre; Bento de Souza, Luis Carlos; Costantini, Costantino; Woitowicz, Vinicius; Hueb, Whady; Stolf, Noedir; Beydoun, Hussein; Baskett, Roger; Curtis, Michael; Kieser, Teresa; Doucet, Serge; Pellerin, Michel; Hamburger, Jaap; Cook, Richard; Kutryk, Michael; Peterson, Mark; Madan, Minakshi; Fremes, Stephen; Mehta, Shamir; Cybulsky, Irene; Prabhakar, Manu; Peniston, Charles; Welsh, Robert; MacArthur, Roderick; Berland, Jacques; Bessou, Jean Paul; Carrié, Didier; Glock, Yves; Darremont, Oliver; Deville, Claude; Grimaud, Jean-Phillipe; Soula, Philippe; Lefèvre, Thierry; Maupas, Eric; Durrleman, Nicolas; Silvestri, Marc; Houel, Remi; Pratt, Alain; Francis, Juthier; Van Belle, Eric; Vicentelli, André; Luchner, Andreas; Hilker, Michael; Endemann, Dierk-Hannes; Felix, Stephan; Wollert, Hans-Georg; Walther, Thomas; Erbel, Raimund; Jacob, Heinz; Kahlert, Philipp; Kupatt, Christian; Näbauer, Michael; Schmitz, Christoph; Scholtz, Werner; Börgermann, Jochen; Schuler, Gerhard; Borger, Michael; Davierwala, Piroze; Fontos, Geza; Székely, László; Bedogni, Francesco; Panisi, Paolo; Berti, Sergio; Glauber, Mattia; Marzocchi, Antonio; Di Bartolomeo, Roberto; Merlo, Maurizio; Guagliumi, Giulio; Fenili, Francesca; Napodano, Massimo; Gerosa, Gino; Ribichini, Flavio; Faggian, Giuseppe; Saccà, Salvatore; Giacomin, Alessandro; Mignosa, Carmelo; Tumscitz, Carlo; Savini, Carlo; Van Mieghem, Nicolas; von Birgelen, C; Grandjean, J; Kubica, Jacek; Anisimowicz, Lech; Zmudka, Krzysztof; Sadowski, Jerzy; Lee, Jae Won; Park, Seung Jung; Hernández García, Jose; Such, Miguel; Macaya, Carlos; Rodríguez Hernández, José Enrique; Maroto, Luis; Serra, Antonio; Padro, Jose; Tenas, Manel Sabaté; De Souza, Anthony; Egred, Mohaned; Clark, Stephen; Trivedi, Uday; Jain, Ajay; Uppal, Rakesh; Redwood, Simon; Young, Christopher; Stables, Rodney H; Pullan, Mark; Uren, Neal; Pessotto, Renzo; Abu-Fadel, Mazen; Peyton, Marvin; Allaqaband, Suhail; O’Hair, Daniel; Bachinsky, William; Mumtaz, Mumbashir; Blankenship, James; Casale, Al; Brott, Brigitta; Davies, James; Brown, David; Cannon, Louis; Talbott, James; Chang, George; Macheers, Steven; Choi, James; Henry, Carl; Cutlip, Donald; Khabbaz, Kamal; Das, Gladwin; Liao, Kenneth; Diver, Daniel; Thayer, John; Dobies, David; Fliegner, Karsten; Fischbein, Michael; Feldman, Ted; Pearson, Paul; Foster, Malcolm; Briggs, Richard; Giugliano, Gregory; Engelman, Daniel; Gordon, Paul; Ehsan, Afshin; Grantham, James; Allen, Keith; Grodin, Jerrold; Jessen, Michael; Gruberg, Luis; Taylor, James R Jr; Gupta, Sandeep; Hermiller, James Jr; Heimansohn, David; Iwaoka, Robert; Chan, Barry; Kander, N Howard; Duff, Steve; Brown, William; Karmpaliotis, Dimitri; Kini, Annapoorna; Filsoufi, Farzan; Kong, David; Lin, Shu; Kutcher, Michael; Kincaid, Edward; Leya, Ferdinand; Bakhos, Mamdouh; Liberman, Henry; Halkos, Mike; Lips, Daniel; Eales, Frazier; Mahoney, Paul; Rich, Jeffrey; Barreiro, Christopher; Cheng, Wen; Metzger, Chris; Greenfield, Tyler; Moses, Jeffrey; Palacios, Igor; MacGillivray, Thomas; Perin, Emerson; Del Prete, Jennifer; Pompili, Vincent; Kilic, Ahmet; Ragosta, Michael; Kron, Irving; Rashid, John; Mueller, Dale; Riley, Robert; Reimers, Carl; Patel, Nirav; Resar, Jon; Shah, Ashish; Schneider, Joel; Landvater, Lance; Shah, Alpesh; Reardon, Michael; Shavelle, David; Baker, Craig; Singh, Jasvindar; Maniar, Hersh; Smith, Conrad; Wei, Lawrence; Strain, Janet; Zapolanski, Alex; Taheri, Hamid; Ad, Niv; Tannenbaum, Mark; Prabhakar, Ganga; Waksman, Ron; Corso, Paul; Wang, John; Fiocco, Michael; Wilson, B Hadley; Steigel, R Mark; Chadwick, Stephanie; Zidar, Frank; Oswalt, John
BACKGROUND:Patients with obstructive left main coronary artery disease are usually treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable alternative to CABG in selected patients with left main coronary disease. METHODS:We randomly assigned 1905 eligible patients with left main coronary artery disease of low or intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). Anatomic complexity was assessed at the sites and defined by a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary anatomy). The primary end point was the rate of a composite of death from any cause, stroke, or myocardial infarction at 3 years, and the trial was powered for noninferiority testing of the primary end point (noninferiority margin, 4.2 percentage points). Major secondary end points included the rate of a composite of death from any cause, stroke, or myocardial infarction at 30 days and the rate of a composite of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. RESULTS:At 3 years, a primary end-point event had occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence limit, 4.0 percentage points; P=0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval, 0.79 to 1.26; P=0.98 for superiority). The secondary end-point event of death, stroke, or myocardial infarction at 30 days occurred in 4.9% of the patients in the PCI group and in 7.9% in the CABG group (P<0.001 for noninferiority, P=0.008 for superiority). The secondary end-point event of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years occurred in 23.1% of the patients in the PCI group and in 19.1% in the CABG group (P=0.01 for noninferiority, P=0.10 for superiority). CONCLUSIONS:In patients with left main coronary artery disease and low or intermediate SYNTAX scores by site assessment, PCI with everolimus-eluting stents was noninferior to CABG with respect to the rate of the composite end point of death, stroke, or myocardial infarction at 3 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776 .).
PMID: 27797291
ISSN: 1533-4406
CID: 5451162

Shock complicating type A acute aortic dissection: Clinical correlates, management, and outcomes

Bossone, Eduardo; Pyeritz, Reed E; Braverman, Alan C; Peterson, Mark D; Ehrlich, Marek; O'Gara, Patrick; Suzuki, Toru; Trimarchi, Santi; Gilon, Dan; Greason, Kevin; Desai, Nimesh D; Montgomery, Daniel G; Isselbacher, Eric M; Nienaber, Christoph A; Eagle, Kim A
AIMS:Shock is among the most dreaded and common complications of type A acute aortic dissection (TAAAD). However, clinical correlates, management, and short- and long-term outcomes of TAAAD patients presenting with shock in real-world clinical practice are not known. METHODS AND RESULTS:We evaluated 2,704 patients with TAAAD enrolled in the International Registry of Acute Aortic Dissection between January 1, 1996, and August 18, 2012. On admission, 407 (15.1%) TAAAD patients presented with shock. Most in-hospital complications (coma, myocardial or mesenteric ischemia or infarction, and cardiac tamponade) were more frequent in shock patients. In-hospital mortality was significantly higher in TAAAD patients with than without shock (30.2% vs 23.9%, P=.007), regardless of surgical or medical treatment. Most shock patients underwent surgical repair, with medically managed patients demonstrating older age and more complications at presentation. Estimates using Kaplan-Meier survival analysis indicated that most (89%) TAAAD patients with shock discharged alive from the hospital survived 5years, a rate similar to that of TAAAD patients without shock (82%, P=.609). CONCLUSIONS:Shock occurred in 1 of 7 TAAAD patients and was associated with higher rates of in-hospital adverse events and mortality. However, TAAAD survivors with or without shock showed similar long-term mortality. Successful early and aggressive management of shock in TAAAD patients has the potential for improving long-term survival in this patient population.
PMID: 27264225
ISSN: 1097-6744
CID: 5450062